Magnetic connection through a sterile field barrier

Abstract

A hub assembly for a robot-controlled intervention device may include an intervention device hub having the intervention device and at least one magnet. The hub assembly may be positioned on the sterile side of a sterile field barrier and configured to magnetically connect to a hub adapter on the non-sterile side of the sterile field barrier, the hub assembly moving axially in response to the axial movement of the hub adapter, and at least one magnet of the hub assembly rotating in response to the rotation of at least one magnet of the hub adapter.

Description

Technical Field

[0001] Incorporation by reference to priority applications Any and all applications in which foreign or domestic priority claims are identified in the application data sheet filed with this application are incorporated herein by reference under 37 CFR 1.57. This application claims priority to U.S. Provisional Patent Application No. 63 / 470,115, entitled "MAGNETIC COUPLING FOR TORQUE TRANSMISSION THROUGH A STERILE BARRIER", filed on May 31, 2023, the entire contents of which are incorporated herein by reference for all purposes and form a part of this specification.

[0002] This application relates to neurovascular procedures, and more specifically, to catheter assemblies and robotic control systems for neurovascular site access.

Background Art

[0003] Various neurovascular procedures, including thrombectomy, diagnostic angiography, coil deployment for embolism, and stent placement, can be achieved via transvascular access. However, the delivery of neurovascular care is limited or delayed by various challenges. For example, there are not enough trained intervention physicians and centers to meet the current demand for neurointerventions. Neurointerventions are difficult and involve complex setup requirements and demands on the surgeon's dexterity. Using both hands, the surgeon must perform precise control over 3-4 coaxial catheters while managing the fluoroscopy system and patient position. The long, winding anatomical structure requires delicate and precise handling. Inadvertent catheter movement can occur due to the storage and release of energy caused by frictional interaction between the coaxial shafts and the patient's vascular system. Supra-aortic access, necessary to reach the neurovascular system, is difficult to achieve, especially in the Type III arch. Once superior aortic access is achieved, adapting the system for neurovascular treatment is a time-consuming process, requiring the removal of guidewires and access catheters, as well as the addition of treatment catheters (and, in some cases, one or more additional catheters) to the stack.

[0004] Therefore, there remains a need for superior aortic access and neurovascular site access systems that address some or all of these challenges and improve the availability of neurovascular procedures. Preferably, the system can additionally drive the device further distally through the superior aortic access to achieve procedures in intracranial vessels. [Overview of the Initiative] [Means for solving the problem]

[0005] Disclosed herein are innovations and embodiments of robotic drive systems for interventional treatment. Several embodiments of the robotic drive systems disclosed herein use a hub adapter (also referred herein as a carriage) to move a hub (also referred herein as a pack or instrument coupler) positioned on the sterile side of a sterile barrier, and one or more surgical instruments are coupled to the hub. In some embodiments, a magnetic field can be generated between the hub adapter and the hub, and the movement of the hub adapter results in the movement of the hub as a result of the magnetic field between the hub and the hub adapter. This is one solution for controlling the movement of the hub of a robotic surgical system through a sterile barrier. In other words, magnetic coupling can be used in any embodiment of the robotic surgical systems disclosed herein, and the movement of a drive device on the non-sterile side of the sterile barrier can cause the movement of at least one device on the sterile side of the sterile barrier to move in any desired direction of movement (for example, in the direction of insertion and / or withdrawal of an instrument into a port entering the patient's body), thereby moving the instrument on the sterile side of the sterile barrier.

[0006] Also disclosed herein are innovations and embodiments of magnetic torque transfer units or systems that can be used to transfer torque loads through a sterile barrier to rotate instruments (e.g., catheters, guidewires, or other devices) configured to be inserted into the body during medical procedures. In some embodiments, a magnetic field can be generated between an active torque element or torque master element and a passive torque element (also referred herein to as a sterile-side torque device). Such a device can be configured such that the rotation of the active torque element on the non-sterile side of the sterile barrier rotates the passive torque element and the instrument connected thereto generally simultaneously. Due to the arrangement of the active torque element relative to the passive torque element, the passive torque element rotates in the opposite direction to the rotation of the active torque element, similar to a pair of meshed gears. In any embodiment, the sterile barrier can separate the active torque element from the passive torque element. In some embodiments, the active torque element and the passive torque element can each have a plurality of magnetic elements having opposite poles. The magnetic element may include a single magnet with multiple different poles (e.g., 4, 6, or 12, but not limited to) or multiple individual magnets with opposite poles in an alternating arrangement, such that the north pole of the magnet or portion of the magnet on the active torque element attracts the south pole of the magnet or portion of the magnet on the passive torque element. The magnetic force in the shear direction will cause the magnetic element of the passive torque element to rotate as the magnetic element of the active torque element rotates. This arrangement can significantly reduce the complexity and cost of the tool driver and the overall robotic drive system.

[0007] Embodiments of robot drive systems are disclosed herein. Some embodiments of robot drive systems may include a torque transfer system which may include an active torque element positioned on the non-sterile side of a sterile barrier and a passive torque element positioned on the sterile side of the sterile barrier. The active torque element may include at least one magnet, and the passive torque element may include at least one magnet and may be configured to be coupled with an intervention device. The active torque element may be configured to rotate in such a way that it applies torque to the passive torque element, thereby rotating the passive torque element and the intervention device.

[0008] Any embodiment of a robot drive system, its devices, and / or a method of using any embodiment of a robot drive system disclosed herein may, in additional embodiments, include, but are not required to include, one or more of the following features, components, steps, and / or details in any combination with any other features, components, steps, and / or details of any other embodiment disclosed herein: an active torque element includes a plurality of magnets arranged around the periphery of the active torque element; a passive torque element includes a plurality of magnets arranged around the periphery of the passive torque element; the robot drive system includes a motor, the motor is coupled to the active torque element and configured to rotate the active torque element; the robot drive system includes a microcontroller electronically coupled to the motor; the robot drive system includes a hub configured to be positioned on the sterile side of a sterile barrier, and the passive torque element is located at the hub The robot drive system includes a hub adapter configured to be positioned on the non-sterile side of the sterile barrier, and the active torque element is connected to the hub adapter; the intervention device is a guidewire, access catheter, guide catheter, or treatment catheter; at least one magnet of the passive torque element can be configured to rotate around a transverse axis with respect to the rotation axis of the intervention device; the active torque element can be configured to rotate around a transverse axis with respect to the rotation axis of the intervention device; the passive torque element includes multiple disk-shaped magnets; the active torque element includes multiple disk-shaped magnets; the active torque element includes multiple arc-segment shaped magnets arranged around the periphery of the active torque element; the active torque element includes multiple magnets arranged around the periphery of the active torque element, with the multiple magnets alternating in polarity of magnetic fields that protrude radially away from each of the multiple magnets;A passive torque element includes multiple arc-segment shaped magnets arranged around the periphery of the passive torque element; the passive torque element includes multiple magnets arranged around the periphery of the passive torque element, and the multiple magnets alternate in the polarity of the magnetic field that protrudes radially away from each of the multiple magnets; at least one magnet of an active torque element includes multiple magnetic poles extending away from the periphery of the active torque element; the multiple magnetic poles alternate between north and south poles around the periphery of at least one magnet of the active torque element; at least one magnet of a passive torque element includes multiple magnetic poles extending away from the periphery of the passive torque element; the multiple magnetic poles alternate between north and south poles around the periphery of at least one magnet of the passive torque element; the passive torque element can be configured to rotate around an axis parallel to the rotation axis of the intervention device; and / or, the active torque element can be configured to rotate around an axis parallel to the rotation axis of the intervention device.

[0009] In any embodiment of the robot drive systems disclosed herein, an active torque element may include a plurality of positive magnetic fields extending radially away from the periphery of the active torque element and a plurality of negative magnetic fields extending radially away from the periphery of the active torque element, each of the plurality of negative magnetic fields of the active torque element being positioned between two positive magnetic fields of the active torque element, and a passive torque element may include a plurality of positive magnetic fields extending away from the periphery of the passive torque element and a plurality of negative magnetic fields extending away from the periphery of the passive torque element, each of the plurality of negative magnetic fields of the passive torque element being positioned between two positive magnetic fields of the passive torque element.

[0010] Also disclosed herein are embodiments of torque transfer systems. In some embodiments, the torque transfer system may include an active torque element configured to be positioned on the non-sterile side of a sterile barrier and a passive torque element configured to be positioned on the sterile side of the sterile barrier. The passive torque element may include a shaft, which is configured to rotate about a longitudinal centerline axis of the shaft, and the passive torque element may include at least a first magnet connected to the shaft of the passive torque element. In any embodiment disclosed herein, the active torque element may include a shaft, which is configured to rotate about a longitudinal centerline axis of the shaft, and the active torque element may include at least a first magnet connected to the shaft of the active torque element. The torque transfer system may be configured such that the first magnet of the passive torque element is magnetically connectable to the first magnet of the active torque element. The torque transfer system can be configured such that, when the first magnet of the passive torque element is magnetically connected to the first magnet of the active torque element, the rotation of the shaft of the active torque element around the axis of the shaft of the active torque element exerts a torque on the shaft of the passive torque element, thereby biasing the passive torque element to rotate around the axis of the shaft of the passive torque element.

[0011] Any embodiment of the torque transfer system, the device thereof, and / or a method of using any embodiment of the torque transfer system disclosed herein may, in additional embodiments, include, but are not required to include, one or more of the following features, components, steps, and / or details in any combination with any other features, components, steps, and / or details of any other embodiment disclosed herein: the first magnet of the passive torque element has opposite polarity to the first magnet of the active torque element, such that the first magnet of the passive torque element is attracted to the first magnet of the active torque element; the active torque element further includes a second magnet, the second magnet being spaced apart from the first magnet of the active torque element and on the centerline axis of the shaft of the active torque element The passive torque element is further comprising a second magnet, which is spaced apart from the first magnet of the passive torque element and spaced apart from the centerline axis of the shaft of the passive torque element; the torque transfer system is configured such that the second magnet of the passive torque element is magnetically connectable to the second magnet of the active torque element; the second magnet of the active torque element has the opposite polarity to the first magnet of the active torque element, and the second magnet of the passive torque element has the opposite polarity to the first magnet of the passive torque element; the second magnet of the passive torque element has the opposite polarity to the second magnet of the active torque element, and the second magnet of the passive torque element is attracted to the second magnet of the active torque element;The active torque element includes a plurality of magnets, each magnet spaced radially apart from the others and spaced radially away from the centerline axis of the shaft of the active torque element; the passive torque element includes a plurality of magnets, each magnet spaced radially apart from the others and spaced radially away from the centerline axis of the shaft of the passive torque element; each of the plurality of magnets of the active torque element can be configured to be alignable and magnetically connectable with each of the plurality of magnets of the passive torque element; the active torque element further includes a second magnet and a third magnet, each magnet spaced radially apart from the others and spaced radially away from the first magnet of the active torque element and spaced radially away from the centerline axis of the shaft of the active torque element; the passive torque element further includes a second magnet and a third magnet, each magnet spaced radially apart from the others and spaced radially away from the first magnet of the passive torque element The torque transfer system can be configured such that the second magnet of the passive torque element is magnetically connectable to the second magnet of the active torque element, and the third magnet of the passive torque element is magnetically connectable to the third magnet of the active torque element; the active torque element further includes a fourth magnet, the fourth magnet is positioned at a distance from the first, second, and third magnets of the active torque element, and at a distance from the centerline axis of the shaft of the active torque element; the passive torque element further includes a fourth magnet, the fourth magnet is positioned at a distance from the first, second, and third magnets of the passive torque element, and at a distance from the centerline axis of the shaft of the passive torque element; the torque transfer system can be further configured such that the fourth magnet of the passive torque element is magnetically connectable to the fourth magnet of the active torque element;The active torque element includes a magnet support element connected to the distal end of the shaft of the active torque element, the magnet support element of the active torque element is configured to support a plurality of magnets in a planar radial arrangement around the centerline axis of the shaft of the active torque element, and the passive torque element includes a magnet support element connected to the distal end of the shaft of the passive torque element, the magnet support element of the passive torque element is configured to support a plurality of magnets in a planar radial arrangement around the centerline axis of the shaft of the passive torque element, and each of the plurality of magnets of the active torque element can be configured to be alignable and magnetically connectable with each of the plurality of magnets of the passive torque element; the magnet support element of the active torque element includes a disk-shaped body and a plurality of recesses formed within the disk-shaped body; Each of the multiple recesses formed in the disc-shaped body of the active torque element can be configured to receive each of the magnets of the active torque element; the disc-shaped body of the magnet support element of the active torque element has a longitudinal centerline axis that coincides with the centerline axis of the shaft of the active torque element; the magnet support element of the active torque element includes a disc-shaped body, the disc-shaped body includes a first recess formed in the disc-shaped body configured to receive a first magnet of the active torque element, and a second recess formed in the disc-shaped body configured to receive a second magnet of the active torque element; and / or the disc-shaped body of the magnet support element of the active torque element has a longitudinal centerline axis that coincides with the centerline axis of the shaft of the active torque element.

[0012] Any embodiment of the torque transfer system, the device thereof, and / or a method of using any embodiment of the torque transfer system disclosed herein may, in additional embodiments, include, but are not required to include, one or more of the following features, components, steps, and / or details in any combination with any other features, components, steps, and / or details of any other embodiment disclosed herein: the magnet support element of the passive torque element has a disk-shaped body and a plurality of recesses formed within the disk-shaped body; each of the plurality of recesses formed within the disk-shaped body of the passive torque element receives each of the magnets of the passive torque element therein It is possible to configure the passive torque element's magnet support element to have a disc-shaped body that has a longitudinal centerline axis that coincides with the centerline axis of the passive torque element's shaft; the passive torque element's magnet support element includes a disc-shaped body that includes a first recess formed in the disc-shaped body that is configured to receive a first magnet of the passive torque element, and a second recess formed in the disc-shaped body that is configured to receive a second magnet of the passive torque element, and the disc-shaped body of the passive torque element's magnet support element has a longitudinal centerline axis that coincides with the centerline axis of the passive torque element's shaft;The first magnet of the active torque element is positioned at a distance from the axis of the shaft of the active torque element, and the center of the first magnet of the active torque element is eccentric with respect to the axis of the shaft of the active torque element, and the first magnet of the active torque element can be configured to rotate in an orbit around the axis of the shaft of the active torque element; the first magnet of the passive torque element is positioned at a distance from the axis of the shaft of the passive torque element, and the center of the first magnet of the passive torque element is eccentric with respect to the axis of the shaft of the passive torque element, and the first magnet of the passive torque element can be configured to rotate in an orbit around the axis of the shaft of the passive torque element; the active torque element and the passive torque element each consist of only two magnets connected to the shafts of the active torque element and the passive torque element, respectively; the robot drive system includes a motor, and the motor controls the active torque element The active torque element is connected to a motor and configured to rotate the active torque element; the active torque element further includes a clutch plate between the shaft and the motor, the clutch plate configured to limit the magnitude of the torque transferred from the motor to the shaft; the robot drive system includes a controller electrically communicating with the motor of the active torque element, the controller configured to control the operation of the motor in response to the controller's input; the active torque element further includes a ball bearing around a portion of the shaft of the active torque element, and the passive torque element further includes a ball bearing around a portion of the shaft of the passive torque element; the active torque element is connected to a housing which may be configured to translate at least axially; the passive torque element further includes a first gear connected to the shaft of the passive torque element, the first gear configured to connect to a second gear and rotate the second gear when the shaft of the passive torque element is rotated;The first and second gears are miter gears; the second gear is connected to the intervention device in the rotational and axial directions, and the intervention device is configured to rotate when the second gear rotates; the passive torque element can be configured to be connected to the intervention device; the intervention device is a guidewire, guide catheter, access catheter, or treatment catheter; the treatment catheter is an aspiration catheter, embolization deployment catheter, stent deployment catheter, flow diverter deployment catheter, diagnostic angiography catheter, stent retriever catheter, blood clot retriever, balloon catheter, catheter for facilitating percutaneous valve repair or replacement, or ablation catheter; the passive torque element can be configured to be connected to a valve, and the passive torque element can be configured to rotate the valve between open and closed positions; the valve is a rotary hemostatic valve or stopcock valve; the first magnet of the active torque element is The first magnet of the passive torque element is positioned 0.4 inches or approximately 0.4 inches away from the centerline axis of the active torque element's shaft; the first magnet of the active torque element is positioned 0.25 inches or approximately 0.25 inches to 1 inch or approximately 1 inch away from the centerline axis of the active torque element's shaft. The first magnet of the passive torque element is positioned at a distance of 0.25 inches or approximately 0.25 inches to 1 inch or approximately 1 inch from the centerline axis of the shaft of the passive torque element; and / or, the first magnet of the active torque element and the first magnet of the passive torque element have diameters of 0.25 inches or approximately 0.25 inches, 0.375 inches or approximately 0.375 inches, or 0.5 inches or approximately 0.5 inches, respectively.

[0013] Also disclosed herein are embodiments of robot drive systems. Any embodiment of a robot drive system disclosed herein may include: a hub adapter, configured to be positioned on the non-sterile side of a sterile barrier and configured to move axially based on inputs provided by a user of the robot drive system; a hub, configured to be positioned on the sterile side of a sterile barrier and configured to move axially in response to the axial movement of the hub adapter in order to adjust the axial position of an intervention device connected to the hub adapter; and one or more torque transfer systems configured as in the embodiments of torque transfer systems disclosed herein. In some embodiments, each active torque element of one or more torque transfer systems can be connected to the hub adapter, and each passive torque element of one or more torque transfer systems can be connected to the hub.

[0014] In some embodiments, one or more torque transfer systems may include multiple torque transfer systems. Additionally, some embodiments of a robot drive system may include a drive magnet, which is connected to a hub adapter and configured to connect to a driven magnet, which is connected to a hub, and when the driven magnet is connected to the drive magnet, the driven magnet moves in response to the movement of the drive magnet, causing the hub to move axially.

[0015] Disclosed herein are embodiments of a method for rotating a surgical device located on the sterile side of a sterile barrier, the method which may include the steps of: magnetically connecting an active torque element located on the non-sterile side of the sterile barrier to a passive torque element located on the sterile side of the sterile barrier, the passive torque element being connected to a surgical device; and rotating the active torque element, thereby rotating the passive torque element magnetically connected to the active torque element and the surgical device connected to the passive torque element. In some embodiments, the surgical device may be a catheter. In some embodiments, the method may further include the step of rotating the passive torque element to move a seal around the catheter between an open position and a closed position.

[0016] Disclosed herein are embodiments of a method for performing a neurovascular procedure, the method comprising the steps of providing a multicatheter assembly including an access catheter, wherein the access catheter is connected to a first passive torque element positioned on the sterile side of a sterile barrier; magnetically connecting a first active torque element to the first passive torque element; and rotating the access catheter by rotating the first active torque element. In some embodiments, the multicatheter assembly may further include a guide wire connected to a second passive torque element, the method may further include the steps of magnetically connecting a second active torque element to a second passive torque element; and rotating the guide wire by rotating the second active torque element. In some embodiments, the first active torque element and the second active torque element may be independently movably supported by a hub adapter. In some embodiments, the multicatheter assembly may further include a guide catheter and a procedure catheter. The treatment catheter may be a suction catheter, embolism dislodgement catheter, stent dislodgement catheter, flow diverter dislodgement catheter, diagnostic angiography catheter, stent retriever catheter, blood clot retriever, balloon catheter, catheter for facilitating percutaneous valve repair or replacement, or ablation catheter.

[0017] Disclosed herein are embodiments of a robot drive system, which may include an active torque element configured to be positioned on the non-sterile side of a sterile barrier and comprising a plurality of magnets configured to rotate about a central axis, and a passive torque element configured to be positioned on the sterile side of the sterile barrier and comprising a plurality of magnets configured to rotate about a central axis. Each of the plurality of magnets of the active torque element may be coupled to one of the plurality of magnets of the active torque element, and the plurality of magnets of the passive torque element may rotate in response to the rotation of the plurality of magnets of the active torque element. Some embodiments may include an intervention device coupled to the passive torque element, which may rotate in response to the rotation of the plurality of magnets of the passive torque element. The intervention device may be configured to move axially along a transverse axis with respect to the central axis of the plurality of magnets of the passive torque element. In some embodiments, the intervention device may be configured to move axially along a transverse axis with respect to the central axis of the plurality of magnets of the passive torque element. The central axes of the multiple magnets in an active torque element can be coaxial with the central axes of the multiple magnets in a passive torque element. In some embodiments, the passive torque element can be connected to a hub. In some embodiments, the active torque element can be connected to a hub adapter.

[0018] Furthermore, embodiments of a method for rotating surgical instruments on the sterile side of a sterile barrier without passing any electrical cables through the sterile barrier are disclosed herein. Furthermore, embodiments of a method for rotating surgical instruments on the sterile side of a sterile barrier by a rotary hub without electrical cables connected to the rotary hub are disclosed herein.

[0019] Disclosed herein are embodiments of hub assemblies for robotically controlled intervention devices, the hub assembly may include an intervention device hub having the intervention device and at least one magnet. The hub assembly is positioned on the sterile side of a sterile field barrier and configured to magnetically connect to a hub adapter on the non-sterile side of the sterile field barrier, the hub assembly is configured to move axially in response to axial movement of the hub adapter, and at least one magnet of the hub assembly is configured to rotate in response to rotation of at least one magnet of the hub adapter. In some embodiments, at least one magnet of the hub assembly is configured to operably connect to an intervention device, the rotation of at least one magnet of the hub assembly causes rotation of the intervention device. In some embodiments, at least one magnet is configured to rotate about a transverse axis with respect to the rotation axis of the intervention device. In some embodiments, at least one magnet of the hub assembly is configured to connect to a valve of a fluid engineering subsystem of the hub assembly. In some embodiments, the valve is a hemostatic valve, and the rotation of at least one magnet of the hub assembly is configured to move the hemostatic valve between an open and a closed configuration. In some embodiments, the valve is configured to selectively facilitate the flow of fluid to or from an intervention device. In some embodiments, the valve is a three-way valve connected to a first flow path for vacuum and a second flow path for saline and contrast agents. In some embodiments, at least one magnet includes a polymagnet having multiple magnetic regions. In some embodiments, the hub assembly is configured to move axially in response to a magnetic force applied to at least one magnet of the hub assembly by at least one magnet of the hub adapter.In some embodiments, at least one magnet of the hub assembly comprises a plurality of magnets, and at least one magnet of the hub adapter comprises a plurality of magnets, and each of the plurality of magnets of the hub assembly is configured to rotate in response to the rotation of one of the plurality of magnets of the hub adapter. In some embodiments, the plurality of magnets of the hub assembly comprises a first magnet and a second magnet, the first magnet being connected to an intervention device such that the rotation of the first magnet causes the rotation of the intervention device, and the second magnet being connected to a valve of a fluid engineering subsystem. In some embodiments, the hub assembly comprises one or more detectable objects configured to be detected by one or more sensors located on the non-sterile side of a sterile field barrier. In some embodiments, the hub assembly comprises a passive torque element, the passive torque element comprising at least one magnet of the hub assembly and a magnet support, the at least one magnet of the hub assembly being mounted on the magnet support, and the passive torque element being configured to rotate in response to the rotation of at least one magnet of the hub adapter. In some embodiments, the magnet support is formed from an iron-based material. In some embodiments, at least one magnet and magnet support of the hub assembly are each disk-shaped. In some embodiments, the hub assembly includes a mount and an intervention device hub that is removably coupled to the mount. In some embodiments, at least one magnet of the hub assembly is mounted on the mount. In some embodiments, at least one magnet of the hub assembly is configured to rotate about a rotation axis, and the hub assembly is configured to move axially along a transverse axis with respect to the rotation axis of at least one magnet of the hub assembly. In some embodiments, the hub assembly includes a plurality of rollers configured to contact a drive surface. In some embodiments, the plurality of rollers are configured to position at least one magnet of the hub assembly away from the drive surface.

[0020] Disclosed herein are embodiments of a robot drive system, which may include a hub adapter, positioned on the non-sterile side of a sterile field barrier and configured to move axially. The hub adapter includes at least one magnet. The hub adapter is configured to connect to a hub assembly on the sterile side of the sterile field barrier, such that axial movement of the hub adapter causes axial movement of the hub assembly, and rotational movement of at least one magnet of the hub adapter causes rotational movement of at least one magnet of the hub assembly. In some embodiments, the hub adapter is configured to translate axially along a first axis, and the hub adapter includes a frame configured to translate axially along a second axis transverse to the first axis. In some embodiments, at least one magnet of the hub adapter is configured to rotate about a third axis, the third axis being parallel to the second axis. In some embodiments, the hub adapter is configured to move axially along the drive surface, and the hub adapter further includes a spring assembly, the spring assembly includes one or more springs, the one or more springs configured to bias at least one magnet of the hub adapter and maintain an air gap between at least one magnet and the drive surface. In some embodiments, at least one magnet of the hub adapter includes a polymagnet having multiple magnetic regions. In some embodiments, at least one magnet of the hub adapter includes multiple magnets, and at least one magnet of the hub assembly includes multiple magnets, and each of the multiple magnets of the hub adapter is configured to rotate to cause rotation of one of the multiple magnets of the hub assembly.In some embodiments, the hub adapter includes an active torque element, the active torque element includes at least one magnet of the hub adapter and a magnet support, the at least one magnet of the hub adapter is mounted on the magnet support, and the active torque element is configured to rotate to cause rotation of at least one magnet of the hub assembly. In some embodiments, the magnet support is formed from an iron-based material. In some embodiments, the magnet and magnet support of the hub adapter are each disc-shaped. In some embodiments, the hub adapter includes a plurality of rollers configured to contact a drive surface. In some embodiments, the plurality of rollers are configured to position at least one magnet of the hub adapter at a distance from the drive surface. In some embodiments, at least one magnet of the hub adapter is configured to rotate about a rotation axis, and the hub adapter is configured to move axially along a transverse axis with respect to the rotation axis of at least one magnet of the hub adapter. In some embodiments, the robot drive system further includes a hub assembly. In some embodiments, at least one magnet of the hub assembly is configured to be coupled to an intervention device of the hub assembly, and the rotation of at least one magnet of the hub assembly causes rotation of the intervention device. In some embodiments, at least one magnet of the hub assembly is configured to connect to a valve of the hub assembly's fluid engineering subsystem. In some embodiments, the valve is a hemostatic valve, and the rotation of at least one magnet of the hub assembly is configured to move the hemostatic valve between an open and a closed configuration. In some embodiments, the valve is configured to selectively facilitate the flow of fluid to or from an intervention device. In some embodiments, the hub assembly is configured to move axially in response to a magnetic force applied to at least one magnet of the hub assembly by at least one magnet of the hub adapter.In some embodiments, the hub assembly includes one or more detectable objects, and the hub adapter includes one or more sensors configured to detect one or more detectable objects. In some embodiments, the hub assembly includes a mount and an intervention device hub that is detachably coupled to the mount.

[0021] Disclosed herein are embodiments of a robot drive system, which may include a frame and at least one magnet positioned on the non-sterile side of a sterile field barrier. The at least one magnet is connected to the frame. The frame is configured to move from a retracted position to an extended position, and one or more magnets are positioned closer to the sterile field barrier in the extended position than in the retracted position. In some embodiments, the robot drive system further includes a hub adapter. The hub adapter includes at least one magnet and a frame, and the hub adapter is configured to move axially along a drive surface. In some embodiments, the hub adapter includes a spring assembly, which includes one or more springs, the one or more springs configured to bias at least one magnet when the frame is in the extended position and to maintain an air gap between the at least one magnet and the drive surface. In some embodiments, the hub adapter is configured to translate axially along a first axis, and the frame is configured to translate axially along a second axis transverse to the first axis between the retracted position and the extended position. In some embodiments, at least one magnet of the hub adapter is configured to rotate about a third axis, the third axis being parallel to a second axis. In some embodiments, the hub adapter includes a support assembly configured to maintain a minimum air gap between at least one magnet and the drive surface. In some embodiments, the support assembly includes a plurality of rollers.

[0022] Disclosed herein are embodiments of robot drive systems, which may include a torque transfer system. The torque transfer system may include an active torque element positioned on the non-sterile side of a sterile field barrier and a passive torque element positioned on the sterile side of the sterile field barrier. The active torque element includes at least one magnet, and the passive torque element includes at least one magnet. The passive torque element is configured to be coupled to an intervention device. The active torque element is configured to rotate to exert torque on the passive torque element, thereby rotating the passive torque element and the intervention device. In some embodiments, the robot drive system further includes a hub assembly configured to be positioned on the sterile side of a sterile field barrier, and the passive torque element is coupled to the hub. In some embodiments, the passive torque element is configured to rotate around a rotation axis perpendicular to the rotation axis of the intervention device.

[0023] Disclosed herein is an embodiment of a method for rotating a surgical device located on the sterile side of a sterile field barrier, the method which may include the steps of: magnetically connecting an active torque element located on the non-sterile side of a sterile field barrier to a passive torque element located on the sterile side of a sterile field barrier, the passive torque element being connected to a surgical device; and rotating the active torque element, thereby rotating the passive torque element magnetically connected to the active torque element and the surgical device connected to the passive torque element.

[0024] Also disclosed herein are embodiments of a method of performing a vascular procedure, the method comprising providing a multi-catheter assembly, magnetically coupling a first active torque element to a first passive torque element, and rotating the first active torque element to rotate an access catheter. The multi-catheter assembly includes an access catheter, which is coupled to a first passive torque element positioned on the sterile side of a sterile field barrier.

[0025] Also disclosed herein are embodiments of a method of performing a vascular procedure, the method comprising magnetically coupling a hub assembly having an intervention device on the sterile side of a sterile field barrier to a hub adapter on the non-sterile side of the sterile field barrier, and rotating at least one magnet of the hub adapter to cause rotation of at least one magnet of the hub assembly.

Brief Description of the Drawings

[0026] [Figure 1] Schematic perspective view of an intervention setup having an imaging system, a patient support table, and a robotic drive system according to the present disclosure. [Figure 2] Longitudinal cross-sectional view showing a concentric relationship between a guide wire having two degrees of freedom, an access catheter having three degrees of freedom, and a guide catheter having one degree of freedom. [Figure 3A] Exploded schematic view of an intervention device hub separated from a support table by a sterile barrier. [Figure 3B] Figure showing an alternative sterile barrier in the form of a shipping tray having one or more storage channels for carrying an intervention device. [Figure 3C] Figure showing an alternative sterile barrier in the form of a shipping tray having one or more storage channels for carrying an intervention device. [Figure 3D]This figure shows an alternative sterile barrier in the form of a shipping tray with one or more storage channels for carrying intervention devices. [Figure 3E] This figure shows an alternative sterile barrier in the form of a shipping tray with one or more storage channels for carrying intervention devices. [Figure 3F] This figure shows an alternative sterile barrier in the form of a shipping tray with one or more storage channels for carrying intervention devices. [Figure 3G] This figure shows an embodiment of an alternative sterile barrier having a convex driving surface. [Figure 3H] This figure shows an embodiment of an alternative sterile barrier having a convex driving surface. [Figure 3I] This figure shows an embodiment of an alternative sterile barrier having a convex driving surface. [Figure 3J] This figure shows an embodiment of an alternative sterile barrier having a convex driving surface. [Figure 3K] This figure shows an embodiment of an alternative sterile barrier having a convex driving surface. [Figure 3L] Figures 3G to 3K illustrate examples of hubs that can be used with sterile barriers. [Figure 3M] Figures 3G to 3K illustrate examples of hubs that can be used with sterile barriers. [Figure 4] This is a schematic elevation cross-sectional view through a hub adapter having a drive magnet separated from the intervention device hub and the driven magnet by a sterile barrier. [Figure 5A] The diagram schematically illustrates three intervention device assemblies. [Figure 5B] The diagram schematically illustrates the intervention device and the four intervention device assemblies. [Figure 6] This is a perspective view of the support table. [Figure 7] This is a close-up view of the motor drive end of the support table. [Figure 8] This is a vertical cross-section passing through the motor and belt drive assembly. [Figure 9] This is a close-up view of the pulley end of the support table. [Figure 10] This is a vertical cross-section showing the belt pulley. [Figure 11] This is a side cross-sectional view passing through the distal portion of a catheter, such as one of the catheters shown in Figures 5A and 5B. [Figure 12A] This diagram schematically illustrates a force sensor integrated into the side wall of a catheter. [Figure 12B] This diagram schematically illustrates a force sensor integrated into the side wall of a catheter. [Figure 13A] This diagram schematically illustrates a sensor for measuring the elastic force in the magnetic connection between a hub and a corresponding hub adapter. [Figure 13B] This diagram schematically illustrates a sensor for measuring the elastic force in the magnetic connection between a hub and a corresponding hub adapter. [Figure 14] This figure schematically illustrates a dual encoder torque sensor for use with the catheter of the present disclosure. [Figure 15] This figure illustrates a blood clot capture and visualization device that can be integrated into a hub and / or connected to a suction line. [Figure 16A] This diagram illustrates an exemplary control mechanism for operating intervention devices driven by each hub. [Figure 16B] This diagram illustrates an exemplary control mechanism for operating intervention devices driven by each hub. [Figure 16C] This diagram illustrates an exemplary control mechanism for operating intervention devices driven by each hub. [Figure 17] This is a schematic side view of an intervention device assembly for superior aortic access and neurointervention procedures. [Figure 18A]This diagram illustrates an exemplary sequence of steps for introducing a catheter assembly configured to provide superior aortic access and neurovascular site access. [Figure 18B] This diagram illustrates an exemplary sequence of steps for introducing a catheter assembly configured to provide superior aortic access and neurovascular site access. [Figure 18C] This diagram illustrates an exemplary sequence of steps for introducing a catheter assembly configured to provide superior aortic access and neurovascular site access. [Figure 18D] This diagram illustrates an exemplary sequence of steps for introducing a catheter assembly configured to provide superior aortic access and neurovascular site access. [Figure 18E] This diagram illustrates an exemplary sequence of steps for introducing a catheter assembly configured to provide superior aortic access and neurovascular site access. [Figure 19] This diagram schematically illustrates an embodiment of the mechanical connection between a drive mechanism and a driven mechanism. [Figure 20A] This diagram illustrates an exemplary sequence of steps for priming a catheter assembly in a stacked configuration. [Figure 20B] This diagram illustrates an exemplary sequence of steps for priming a catheter assembly in a stacked configuration. [Figure 20C] This diagram illustrates an exemplary sequence of steps for priming a catheter assembly in a stacked configuration. [Figure 21A] This diagram illustrates an exemplary sequence of steps for priming a catheter assembly in a stacked configuration. [Figure 21B] This diagram illustrates an exemplary sequence of steps for priming a catheter assembly in a stacked configuration. [Figure 22] Figures 21A and 21B illustrate an exemplary test system for the priming process. [Figure 23A] This figure shows an example of a catheter assembly. [Figure 23B] This figure shows an example of catheter assembly after priming. [Figure 23C] This is an example of catheter assembly after a priming procedure that includes relative movement between adjacent catheters. [Figure 23D] Figures 23A to 23C illustrate exemplary catheter assemblies. [Figure 23E] Figures 23A to 23C illustrate exemplary catheter assemblies. [Figure 23F] Figures 23A to 23C illustrate exemplary catheter assemblies. [Figure 24] This is a schematic diagram of the control system. [Figure 25] This is a perspective view of a portion of a robot drive system, showing the passive torque element of the torque transfer system connected to the hub and the active torque element of the torque transfer system connected to the hub adapter. [Figure 26] Figure 25 shows exploded views of the active torque element and passive torque element. [Figure 27] Figure 25 is a perspective view of the passive torque element. [Figure 28] Figure 25 is a second perspective view of the passive torque element. [Figure 29] Figure 25 is an exploded view of the passive torque element. [Figure 30] Figure 25 is a second exploded view of the passive torque element. [Figure 31] This is a perspective view of an embodiment of a passive torque element connected to a rotary hemostatic valve. [Figure 32] Figure 31 is a second perspective view of the passive torque element and hemostatic valve. [Figure 33] Figure 31 is an exploded view of the passive torque element and hemostatic valve. [Figure 34]This is a perspective view of a portion of a robot drive system, showing the passive torque element and active torque element connected to the hub. [Figure 35] This is a second perspective view of a portion of the robot control system shown in Figure 34. [Figure 36] This is a first perspective view of an embodiment of an active torque element. [Figure 37] Figure 36 is a second perspective view of the active torque element. [Figure 38] Figure 36 is an exploded perspective view of an embodiment of the active torque element. [Figure 39] Figure 36 is a front view of the magnet of the active torque element. [Figure 40] Figure 39 is a front view of the magnet. [Figure 41] This is a cross-sectional view of the magnet in Figure 40, taken along line AA. [Figure 42A] This is a side view of an embodiment of the torque transfer system. [Figure 42B] Figure 42A is a perspective view of the torque transfer system. [Figure 43A] This is a perspective view of an embodiment of a torque transfer system. [Figure 43B] Figure 43A is a side view of the torque transfer system. [Figure 43C] Figure 43A is a first exploded view of the torque transfer system. [Figure 43D] Figure 43A is a second exploded view of the torque transfer system. [Figure 43E] Figure 43A is a first perspective view of the disk-shaped main body of the active torque element of the torque transfer system. [Figure 43F] Figure 43E is a second perspective view of the disk-shaped main body. [Figure 43G] Figure 43A is a perspective view of multiple torque transfer systems. [Figure 43H] This is a perspective view of a portion of a robot drive system, including the hub, the hub adapter, and the torque transfer system shown in Figure 43A. [Figure 43I] Figure 43H is a second perspective view of a portion of the robot drive system. [Figure 43J] Figure 43H is a side view of a portion of the robot drive system. [Figure 43K] Figure 43H is a perspective view of the hub adapter. [Figure 43L] Figure 43H is a perspective view of the hub. [Figure 43M] Figure 43H is a perspective view of the hub adapter. [Figure 43N] Figure 43H is a perspective view of a portion of the hub. [Figure 43O] This is a second perspective view of the hub portion in Figure 43N. [Figure 43P] Figure 43H is a side view of a portion of the robot drive system. [Figure 44A] This is a perspective view of a portion of an embodiment of a torque transfer system, showing an active torque element and a passive torque element. [Figure 44B] Figure 44A is a top view of an embodiment of the active torque transfer element. [Figure 44C] Figure 44A is a top view of the magnet of the active torque transfer element. [Figure 44D] Figure 44A is a side view of the magnet of the active torque transfer element. [Figure 45A] This is a top perspective view of the active torque subsystem of the torque transfer system. [Figure 45B] Figure 45A is a bottom perspective view of the active torque subsystem. [Figure 45C] This is a top perspective view of the passive torque subsystem of the torque transfer system. [Figure 45D] Figure 45C is a bottom perspective view of the passive torque subsystem. [Figure 45E] Figure 45C is a top perspective view of a portion of the passive torque subsystem. [Figure 45F] Figure 45C is a top perspective view of a portion of the passive torque subsystem. [Figure 45G]Figure 45C is a top perspective view of a portion of the passive torque subsystem. [Figure 46A] This diagram illustrates an example of a method for generating repulsive force within a torque transfer system. [Figure 46B] This diagram illustrates an example of a method for generating repulsive force within a torque transfer system. [Figure 46C] This diagram illustrates an example of a method for generating repulsive force within a torque transfer system. [Figure 47A] This diagram illustrates an example of a method for generating repulsive force within a torque transfer system. [Figure 47B] This diagram illustrates an example of a method for generating repulsive force within a torque transfer system. [Figure 47C] This diagram illustrates an example of a method for generating repulsive force within a torque transfer system. [Figure 48A] This is a perspective view of the hub assembly. [Figure 48B] Figure 48A is a bottom view of the hub assembly. [Figure 48C] Figure 48A is a top view of the internal mechanism of the hub assembly. [Figure 48D] Figure 48A is a perspective view of the hub assembly mount. [Figure 48E] Figure 48A is a perspective view of the internal components of the hub assembly. [Figure 48F] Figure 48E is a top view of the internal components of the hub. [Figure 48G] Figure 48E is a side view of the internal components of the hub. [Figure 48H] Figure 48E is a cross-sectional view of the internal components of the hub. [Figure 48I] Figure 48E is a perspective view of the internal components of the hub. [Figure 48J] This is a schematic diagram of a fluid management system. [Figure 48K] Figure 48D is a top view of the fluid management system inside the mount. [Figure 49A] This is a perspective view of the hub adapter. [Figure 49B]Figure 49A is a bottom view of the hub adapter. [Figure 49C] Figure 49A is a side view of the hub adapter. [Figure 49D] This is a side view of the hub adapter shown in Figure 49A in its extended state. [Figure 49E] This is a side view of the hub adapter in Figure 49A in the retracted position. [Figure 49F] Figure 49A is a top view of the hub adapter. [Figure 49G] Figure 49A is a top view of the hub adapter with a non-planar drive surface. [Figure 50A] This is a rear view of the hub assembly. [Figure 50B] Figure 50A is a schematic diagram of the fluid dynamics management system within the hub assembly. [Figure 51A] This is a perspective view of multiple hub assemblies mounted on a drive table. [Figure 51B] This is a perspective view of multiple hub assemblies mounted on a drive table. [Figure 51C] This is a top view of multiple hub adapters aligned with their corresponding hub assemblies. [Figure 51D] This is a top view of multiple hub adapters aligned with their corresponding hub assemblies. [Figure 51E] This is a side view of the hub adapter, which is aligned with the hub assembly. [Figure 51F] This is a side view of the hub adapter, which is aligned with the hub assembly. [Figure 51G] This is a side view of the hub adapter, which is aligned with the hub assembly. [Figure 51H] This is a schematic diagram of a hub adapter compatible with a hub assembly having a hard stop mechanism. [Figure 51I] This is a schematic diagram of a hub adapter compatible with a hub assembly having a hard stop mechanism. [Figure 51J] This is a schematic diagram of a hub adapter compatible with a hub assembly having a disposable position sensor. [Figure 51K]This is a schematic diagram of a hub adapter compatible with a hub assembly having a disposable position sensor. [Figure 52A] This is a perspective view of a magnet. [Figure 52B] This is a top view of two magnets. [Figure 52C] This is a top view of the torque element subassembly. [Figure 53A] Figure 52B is a top view of the magnetic connection between the magnets. [Figure 53B] Figure 52B is a top view of the magnetic connection between the magnets. [Figure 53C] Figure 52B is a top view of the magnetic connection between the magnets. [Figure 53D] Figure 52B is a top view of the magnetic connection between the magnets. [Figure 54A] This is a top view of the torque element subassembly. [Figure 54B] This is a top view of the torque element subassembly. [Figure 54C] This is a top view of the torque element subassembly. [Figure 54D] This is a top view of the torque element subassembly. [Figure 54E] This is a top view of the torque element subassembly. [Figure 55A] This is a schematic diagram of a portion of the hub adapter. [Figure 55B] This is a schematic diagram of a movable component that may be used with the hub adapter shown in Figure 55A. [Modes for carrying out the invention]

[0027] In certain embodiments, a system is provided for advancing a guide catheter from a femoral or radial artery access into one of the ostiums of the great vessels located above the aortic arch, thereby achieving superior aortic access. The surgeon can then take over and advance the intervention device into the cerebrovascular system via the robotically controlled guide catheter.

[0028] In some implementations, the system can be additionally configured to obtain robotically controlled access to intracranial blood vessels and to perform aspiration thrombectomy or other neurovascular procedures.

[0029] The drive table can be positioned above or beside the patient and can be configured to advance and retract two, three, or more different intravascular devices (e.g., oriented concentrically or side by side) axially, and in some cases, rotate and / or deflect them laterally.

[0030] The hub or hub assembly is movable along a path parallel to the surface of the drive table, allowing the intervention device to be advanced or retracted as desired. Each hub (or hub assembly) may 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 catheter hubs. Each hub (or hub assembly) can electrically communicate with an electronic control system via a hardwired connection, an RF wireless connection, or a combination of both.

[0031] Each hub (or hub assembly) may be independently movable across the surface of the sterile field barrier membrane supported by a drive table. Each hub (or hub assembly) may be magnetically and detachably coupled to a specific drive carriage located on the table side of the sterile field barrier. The drive carriage may also be referred to as a hub adapter. The drive system can independently move each hub (or hub assembly) proximal or distal across the surface of the barrier, thereby moving the corresponding intervention device proximal or distal within the patient's vascular system.

[0032] The carriage or hub adapter on the drive table, which magnetically connects to the hub to provide linear motion action, can be universal. The functionality of the catheter / guidewire can be provided based on what is incorporated into the hub and shaft design. This allows for the flexibility to configure a system for performing a wide range of procedures using a variety of intervention devices on the same drive table. In addition, the intervention devices and methods disclosed herein can be readily adapted for use with any of the variety of other drive systems (e.g., any of the variety of robotic surgical drive systems).

[0033] Figure 1 is a schematic perspective view of an intervention setup 10 having a patient support table 12 for supporting a patient 14. An imaging system 16 may be provided together with a robotic intervention device drive system 18 according to this disclosure.

[0034] The drive system 18 may include, for example, a guidewire hub 26, an access catheter hub 28, and a support table 20 for supporting the guide catheter hub 30. In this context, the term “access” catheter can be any catheter having a lumen with at least one distally or laterally facing distal opening, which may be used to provide access for an additional device to be advanced through or along it for aspirating a thrombus, or for injecting saline, contrast medium, or therapeutic agent.

[0035] Depending on the desired clinical procedure, more or fewer intervention device hubs may be provided. For example, in a particular embodiment, a diagnostic angiography procedure may be performed using only a guidewire hub 26 and an access catheter hub 28 for driving a guidewire and an access catheter (in the form of a diagnostic angiography catheter), respectively. Multiple intervention devices 22 extend between a support table 20 and a femoral access point 24 over the patient 14 (in the illustrated example). Depending on the desired procedure, access may be achieved by percutaneous or cutdown access to any of the various arteries or veins, such as the femoral artery or radial artery. Although disclosed herein primarily in the context of neurovascular access and procedures, robot-driven systems and associated intervention devices can be readily configured for use in a wide variety of additional medical interventions in peripheral and coronary arterial and venous vascular systems, gastrointestinal systems, lymphatic systems, cerebrospinal fluid lumens or spaces (e.g., spinal canal, ventricles, and subarachnoid space), pulmonary airways, treatment sites accessible via transureteral or transurethral or fallopian tube navigation, or in other hollow organs or structures within the body (e.g., in intracardiac or structural cardiac applications such as valve repair or replacement, or in any intraluminal procedure).

[0036] For example, a display 23 for viewing fluoroscopic images, catheter data (e.g., fiber Bragg grating optical fiber sensor data or other force or shape detection data) or other patient data can be supported by a support table 20 and / or patient support 12. Alternatively, the physician input / output interface, including the display 23, can be located remotely from the patient, for example, behind radiation shielding, in a different room from the patient, or in a different facility from the patient.

[0037] In the illustrated example, the guidewire hub 26 is supported by a support table 20 and is movable along the table to advance the guidewire into and out of the patient 14. The access catheter hub 28 is also supported by the support table 20 and is movable along the table to advance the access catheter into and out of the patient 14. The access catheter hub may also be configured to rotate the access catheter in response to operation of the rotation control unit, and to deflect the deflectable portion of the access catheter laterally in response to operation of the deflection control unit.

[0038] Figure 2 is a longitudinal cross-sectional view schematically showing the motion relationship between a guide wire 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).

[0039] Referring to Figure 3A, the support table 20 includes a drive mechanism, described in more detail below, for independently driving the guidewire hub 26, the access catheter hub 28, and the guide catheter hub 30. A buckling prevention feature 34 may be provided in the proximal buckling prevention zone to resist buckling of the portion of the intervention device spanning the distance between the support table 20 and the femoral artery access point 24. The buckling prevention feature 34 may include a plurality of concentric, expandable, axially extendable, and foldable tubes through which the intervention device extends.

[0040] Alternatively, one or more proximal segments of the device shaft may be configured with reinforced stiffness to reduce buckling under compression. For example, the proximal reinforced segment may extend distally from the hub over a distance of at least about 5 or 10 centimeters, but typically no more than about 120 or 100 centimeters, to support the device between the hub and the access point 24 above the patient. Reinforcement can be achieved by using metal or polymer tubing, or by embedding at least one or two or more axially extending elements, such as elongated wires or ribbons, into the walls of the device shaft. In some implementations, the extending elements can be hollow and can be protected from wear, buckling, or damage at the input and output of the hub. In some embodiments, the hollow extending elements can be hollow flexible coatings attached to the hub. The hollow extending elements (e.g., hollow flexible coatings) can cover a portion of the device shaft when passed through the hub. In some embodiments, where the hollow, extending element is a coating, the coating can be attached to a portion of the hub, so that passing the catheter device through the hub 26, 28, or 30 also passes the catheter device through the coating. In some implementations, a buckling prevention device can be installed on, around, or surrounding the device shaft to avoid misalignment or insertion angle errors between the hubs or between the hubs and the insertion point. The buckling prevention device can be a laser-cut hypotube, a spring, a telescopic tube, or tensioned split tubing.

[0041] In some implementations, multiple deflection sensors can be placed along the length of the catheter to identify buckling. Identifying buckling can be done by detecting distal advancement of the hub while the distal tip of the catheter or intervention device remains stationary. In some implementations, buckling can be detected by detecting an energy load (e.g., due to friction) occurring between the catheter shafts.

[0042] Alternatively, a slender tubular stiffening structure can be embedded within or supported on the outside of the device wall, such as a tubular polymer extruder or hypotube of a certain length. Alternatively, a removable stiffening mandrel can be placed in the lumen in the proximal segment of the device and removed proximal following distal advancement of the hub toward the patient access site, preventing buckling of the proximal shaft during distal advancement of the hub. Alternatively, one or more proximal segments of the device shaft can be constructed as a tubular hypotube, which can be machined (e.g., by laser) so that its mechanical properties vary along its length. This proximal segment can be formed from stainless steel, nitinol, and / or cobalt-chromium alloy and optionally combined with a polymer component that can provide lubricity and hydraulic sealing. In some embodiments, this proximal segment can be formed from a polymer such as polyetheretherketone (PEEK). Alternatively, the wall thickness or diameter of the intervention device can be increased in the buckling prevention zone.

[0043] In certain embodiments, a device shaft with high rigidity (e.g., in the axial and torsional directions) can provide improved motion transmission from the proximal end to the distal end of the device shaft. For example, the device shaft can be more responsive to motion applied at the proximal end. Such embodiments may be advantageous for robotic drive in the absence of tactile feedback to the user.

[0044] In some embodiments, a flexible coating can be applied to the device shaft and / or hub to reduce the frictional force between the device shaft and / or hub and the second device shaft as the second device shaft passes through it.

[0045] The intervention device hub can be separated from the support table 20 by a sterile barrier 32, which may also be referred to as a sterile field barrier. The sterile barrier 32 may include a thin plastic film such as polyethylene terephthalate (PET), polyethylene terephthalate glycol (PETG), polyethylene terephthalate (PETE), high-density polyethylene (HDPE), polyvinyl chloride (PVC), low-density polyethylene (LDPE), polypropylene (PP), polystyrene (PS), or styrene. This allows the support table 20 and associated drive systems to be located on the non-sterile side (bottom) of the sterile barrier 32. The guidewire hub 26, access catheter hub 28, guide catheter hub 30, and associated intervention devices are all located on the sterile side (top) of the sterile barrier 32. The sterile barrier is preferably waterproof and may also serve as a tray used in packaging the intervention devices (further discussed below). The intervention device can be supplied individually or as a pre-assembled kit, which is shipped and stored in a tray and enclosed in sterile packaging.

[0046] Figures 3B–3F schematically illustrate an alternative sterile barrier in the form of a dual-function sterile barrier for placement on a support table during intervention procedures, and a shipping tray having one or more storage channels for carrying sterile intervention devices. The sterile barrier can also act as a sterile working surface for preparing catheters or other devices during procedures.

[0047] Referring to Figures 3B and 3C, a sterile barrier 32 in the form of a pre-shaped tray is illustrated to fit onto an elongated support table 20. When 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 the intervention device hub. In one implementation configuration, the support surface 104 has an axial length greater than the length of the intended intervention device in a linear drive configuration.

[0048] The length of the support surface 104 is typically at least about 100 centimeters and will range from about 100 centimeters to about 2.7 meters. Shorter lengths can be used in systems configured to advance the drive coupler along an arc-shaped path. In some embodiments, two or more support surfaces can be used instead of a single support surface 104. The two or more support surfaces can have a combined length between 100 centimeters and about 2.7 meters. The width of the linear drive table is preferably from about 30 centimeters to about 80 centimeters or less.

[0049] At least a first channel 106 may be provided, which extends axially over at least a portion of the length of the support table 20. In the illustrated configuration, the first channel 106 extends over the entire length of the support table 20. Preferably, the first channel 106 has sufficient length to hold the intervention device, as well as sufficient width and depth to hold the corresponding hub (for example, by providing lateral support to prevent the hub from dislodgement when a force is applied to the hub). The first channel 106 is defined within the floor 108, the outer sidewall 110, and the inner sidewall 111, forming an upward-facing concave surface. Optionally, a second channel 112 may be provided. The second channel 112 may be positioned on the same side or opposite side of the upper support surface 104 from the first channel 106. It is possible to provide two, three, or more additional recesses, such as additional channels or wells, to hold additional medical devices or supplies that may be useful during interventional procedures, and to collect fluids and function as a lavage tank for catheters and associated devices.

[0050] Referring to Figure 3D, the guide catheter hub 30 is shown positioned on the upper support surface 104 and magnetically coupled to a corresponding coupler that holds a drive magnet positioned below the sterile barrier 32. The access catheter hub 28 and access catheter 29, as well as the guide wire hub 26 and guide wire 27, are shown as being present in the first channel 106, for example, before introduction through the guide catheter 31 or following removal from the guide catheter 31.

[0051] The intervention device can be positioned within channel 106 and enclosed within a sterile barrier for shipment. In a clinical setting, the upper panel of the sterile barrier can be removed, or the tubular sterile barrier packaging can be opened and axially removed from the support table 20 and sterile barrier 32 assembly to expose the sterile upper side of the sterile barrier tray and any included intervention device. The intervention device can be carried separately within the channel, or it can be pre-assembled within an access assembly or treatment assembly, which is discussed in further detail below.

[0052] Figures 3D to 3F illustrate a support table with the sterile barrier in the appropriate position, and Figure 3E illustrates the intervention device configured within the access assembly for aortic access, following the connection of the access assembly to the corresponding carriage below the sterile barrier. The access assembly can be pre-assembled with the guidewire fully advanced through the access catheter and the access catheter fully advanced through the guide catheter. In embodiments where the access catheter or other catheter is pre-shaped (i.e., pre-curved or not straight), the guidewire and / or outer catheter can be positioned such that the relatively rigid section does not overlap with the curved, rigid section of the pre-shaped catheter, for example, to avoid creeping or straightening the pre-shaped catheter and / or to avoid introducing a curve into an otherwise straight catheter. The access assembly can be lifted from the channel 106 and positioned on the support surface 104 for connection to the respective drive magnets and for introduction into the patient. The guide catheter hub 30 is the most distal hub. The access catheter hub 28 is positioned proximal to the guide catheter hub, allowing the access catheter 29 to extend distally through the guide catheter. The guide wire hub 26 is positioned proximal to allow the guide wire 27 to advance through the access catheter 29 and the guide catheter 31.

[0053] The treatment assembly, following the introduction of the treatment assembly through the guide catheter 31 used to achieve superior aortic access, is illustrated in Figure 3F. In this configuration, the guide catheter 31 remains at the distal end of the intervention device. The first treatment catheter 120 and its corresponding hub 122 are illustrated to extend through the guide catheter 31. An optional second treatment catheter 124 and its corresponding hub 126 are illustrated to extend through the first treatment catheter 120. The guidewire 27 extends through at least a portion of the second treatment catheter 124 in the rapid exchange version of the second treatment catheter 124, or through the entire length of the second treatment catheter 124 in the over-the-wire configuration.

[0054] As discussed in more detail in relation to Figure 17, a multi-catheter stack can be used to achieve both access and endovascular procedures without the need for catheter changes. This can be achieved in either manually driven or robotically controlled procedures. In one example, the guide catheter 31 may include a catheter having an inner diameter of at least about 0.08 inches, and in one implementation, an inner diameter of about 0.088 inches. The first treatment catheter 120 may include a catheter having an inner diameter in the range of about 0.065 inches to about 0.075 inches, and in one implementation, catheter 120 has an inner diameter of about 0.071 inches. The second treatment catheter 124 may be an access catheter with an OD sized to allow advancement through the first treatment catheter 120. The second treatment catheter may be maneuverable and have a deflection control unit 2908 configured to deflect the distal end of the catheter laterally. Furthermore, the second access catheter may have an internal lumen sized to allow a suitably sized guidewire to remain inside the second access catheter while contrast agent is being injected through the second access catheter.

[0055] In certain embodiments, catheter 31 can be a “large bore” access catheter or guide catheter having a diameter of at least about 0.075 or at least about 0.080 inches. Catheter 120 can be a suction catheter having a diameter in the range of about 0.060 inches to about 0.075 inches. Catheter 124 can be a maneuverable catheter with a deflectable distal tip having a diameter in the range of about 0.025 inches to about 0.050 inches. Guidewire 27 can have a diameter in the range of about 0.014 inches to about 0.020 inches. In one example, catheter 31 can have a diameter of about 0.088 inches, catheter 120 can have a diameter of about 0.071 inches, catheter 124 can have a diameter of about 0.035 inches, and guidewire 27 can have a diameter of about 0.018 inches.

[0056] In one commercial implementation, a pre-assembled access assembly (guide catheter, access catheter, and guidewire) can be carried in a first channel on a sterile barrier tray, and a pre-assembled treatment assembly (one or two treatment catheters and guidewires) can be carried in the same or a different second channel on the sterile barrier tray. Additionally, one, two, or more additional catheters or intervention tools can be provided depending on potential needs during the intervention procedure.

[0057] Figures 3G to 3K illustrate an alternative embodiment of a sterile barrier having a convex driving surface (e.g., a convex crowned road-shaped driving surface). Figure 3G is a cross-sectional view of the sterile barrier 232. The sterile barrier 232 includes a convex upper support surface 204. Fluid channels 205 and 207 are positioned laterally and downward of the support surface 204 for self-clearing or draining of fluid from the support surface 204 (e.g., during an intervention procedure). Fluid channels 205 and 207 can extend axially to at least a portion of the length of the sterile barrier.

[0058] Figures 3I, 3J, and 3K illustrate a cross-sectional perspective view, a cross-sectional view, and a top cross-sectional view of the proximal end of the sterile barrier 232, respectively. As shown, in Figures 3I–3K, the sterile barrier 232 may include a trough 240 communicating with fluid channels 205 and 207. The trough 240 is capable of receiving fluid from channels 205 and 207 (for example, during an intervention procedure). The trough 240 may be positioned at least partially below the fluid channels 205 and 207 so that the fluid in channels 205 and 207 flows into the trough 240. In certain embodiments, the fluid channels 205 and 207 may be angled with respect to a horizontal plane (for example, descending from the end of the channel furthest from the trough 240 to the trough 240) so that the fluid in channels 205 and 207 is directed towards the trough 240. For example, channels 205 and 207 can increase in depth from the end of the channel furthest from the trough 240 toward the trough 240. Alternatively, the sterile barrier 232 and / or support table can be positioned at a predetermined angle to the horizontal plane during part or all of the intervention procedure, such that the ends of channels 205 and 207 furthest from the trough 240 are positioned higher than the trough 240. For example, the sterile barrier 232 and / or support table can be constructed or positioned in an angled configuration such that the end of the sterile barrier 232 and / or support table opposite the trough 240 is positioned higher than the trough 240. Alternatively or additionally, the drive mechanism is capable of temporarily tilting the sterile barrier 232 and / or support table so that the end of the sterile barrier 232 and / or support table opposite the trough 240 is positioned higher than the trough 240 (for example, by lifting the end of the sterile barrier and / or support table opposite the trough 240, or by lowering the end of the sterile barrier 232 and / or support table on which the trough 240 is positioned), allowing the fluid in channels 205 and 207 to flow into the trough 240.

[0059] The trough 240 may include a drain hole 242. The trough 240 may be shaped, sized, and / or otherwise configured so that the fluid in the trough 240 empties into the drain hole 242. The drain hole 242 may include tubing, barb fittings, and / or an on / off valve for removing fluid from the trough 240. As shown in Figures 3I to 3K, the trough 240 may be positioned at the proximal end of the sterile barrier 232. In an alternative embodiment, the trough 240 may be positioned at the distal end of the sterile barrier 232. In some embodiments, the sterile barrier 232 may include a first trough 240 at its proximal end and a second trough 240 at its distal end. In some embodiments, the trough 240 may also be used as a washing tank.

[0060] The first channel 206 can extend axially to at least a portion of the length of the sterile barrier 232. The channel 206 can have sufficient length to hold the intervention device, as well as sufficient width and depth to hold the corresponding hub (for example, by providing support to prevent the hub from coming off when a force is applied to the hub). Optionally, a second channel 212 can be provided. The second channel 212 can be positioned on the same side as the first channel 206 or on the opposite side of the upper support surface 204. Figure 3G illustrates the channel 212 positioned on the opposite side of the support surface 204 from the channel 206. Figure 3H is a cross-sectional view illustrating an alternative embodiment of the sterile barrier 232 in which the channel 212 is on the same side as the channel 206 and the support surface 204.

[0061] As shown in Figures 3G and 3H, channels 206 and 212 can generally have triangular, wedge-shaped, or otherwise angled cross-sections to hold the hubs at a predetermined angle to the horizontal plane. Holding the hubs at a predetermined angle to the horizontal plane can allow for a smaller width of the sterile barrier 232.

[0062] It is possible to provide two, three, or more additional recesses, such as additional channels or wells, to hold additional medical devices or supplies that may be useful during interventional procedures, and to collect fluids and function as a lavage tank for catheters and associated devices.

[0063] In some embodiments, the sterile barrier 232 may include one or more structural ribs 236. The sterile barrier 232 may further include one or more frame support bosses 228 and 238.

[0064] In the embodiment of the sterile barrier 232 shown in Figure 3G, the width x1 can be 14 inches, approximately 14 inches, between 12 and 16 inches, between 10 and 18 inches, or any other suitable width. In the embodiment of the sterile barrier 232 shown in Figure 3H, the width x1 can be 15 inches, approximately 15 inches, between 13 and 17 inches, between 11 and 19 inches, or any other suitable width. The height y1 of the support surface 204 can be 0.125 inches, approximately 0.125 inches, between 0.1 and 0.15 inches, or any other suitable height. In some embodiments, the support surface 204 can be recessed from the upper surface 233 of the sterile barrier 232. The height y2 between the bottom of the support surface 204 and the top surface 233 can be 0.5 inches, approximately 0.5 inches, between 0.25 and 0.75 inches, or any other suitable height. The width x2 from the lateral edge of channel 205 to the lateral edge of channel 207 can be 5 inches, approximately 5 inches, between 4 and 6 inches, or any other suitable width. The width x3 of the support surface 204 can be 4 inches, approximately 4 inches, between 3 and 5 inches, or any other suitable width. The height y3 of channel 206 and / or channel 212 can be 1.5 inches, approximately 1.5 inches, between 1 and 2 inches, or any other suitable height. The width x4 of channel 206 and / or channel 212 can be 3 inches, approximately 3 inches, between 2 and 4 inches, or any other suitable width. Channel 206 and / or Channel 212 can be defined by an arc angle α of 90°, an arc angle α of approximately 90°, an arc angle α between 80° and 100°, or any other suitable angle, and by a radius of curvature of 0.125 inches, an arc angle α of approximately 0.125 inches, an arc angle α between 0.1 inches and 0.15 inches, or any other suitable radius of curvature.In certain embodiments, an arc angle α of 90° or approximately 90° can be used to hold a hub having a rectangular or generally rectangular cross-section. The support surface 204 can be defined by a radius of curvature of 13 inches, approximately 13 inches, between 11 and 15 inches, or any other suitable radius of curvature. The channels 205 and / or channels 207 can be defined by a radius of curvature of 0.25 inches, approximately 0.25 inches, between 0.15 and 0.35 inches, or any other suitable radius of curvature.

[0065] Figures 3L and 3M illustrate exemplary dimensions of a hub 250 that may be used with a sterile barrier 232 as shown in Figures 3G to 3K. The hub 250 can be any of the hubs described herein. In certain embodiments, the hub 250 can have a width w1 of 3.75 inches, a width w1 of about 3.75 inches, a width w1 between 3.25 inches and 4.25 inches, or any other suitable width. The hub 250 can have a height h1 of 1.5 inches, a height h1 of about 1.5 inches, a height h1 between 1.25 inches and 1.75 inches, or any other suitable height. Alternatively, the hub 250 can have a height h2 of 2 inches, a height h2 of about 2 inches, a height h2 between 1.75 inches and 2.25 inches, or any other suitable height. In some embodiments, the hub 250 can have a length L1 of 2.5 inches, a length L1 of approximately 2.5 inches, a length L1 between 2 and 3 inches, or any other suitable length. Alternatively, the hub 250 can have a length L2 of 4 inches, a length L2 of approximately 4 inches, a length L2 between 3.25 and 4.75 inches, or any other suitable length.

[0066] In some embodiments, the upper surface of the support table may include surface features that generally correspond to those of the sterile barrier 232. For example, the support table may include a convex surface configured to correspond to the shape, size, and location of the support surface 204, and / or one or more recesses configured to correspond to the shape, size, and location of the channels 205 and 207.

[0067] In alternative embodiments, a planar support surface (e.g., the support surface 104 of the sterile barrier 32) can be positioned at a predetermined angle to the horizontal plane to facilitate fluid drainage. In some embodiments, the sterile barrier and / or support table can be positioned at a predetermined angle to the horizontal plane to facilitate fluid drainage during part or all of the intervention procedure. For example, the sterile barrier and / or support table can be constructed or positioned in an angled configuration to facilitate fluid drainage (e.g., one lateral side of the planar support surface is positioned higher than the other lateral side of the planar support surface, with the proximal end higher than the distal end, or vice versa). Alternatively or additionally, the drive mechanism may temporarily tilt the sterile barrier and / or support table to facilitate fluid drainage (for example, by positioning one lateral side of the planar support surface higher than the other lateral side of the planar support surface, with the proximal end higher than the distal end, or vice versa). For example, the drive mechanism may raise or lower one lateral side of the sterile barrier and / or support table, the proximal end of the sterile barrier and / or support table, and / or the distal end of the sterile barrier and / or support table.

[0068] In certain embodiments, the support surface (e.g., the support surface 104 of the sterile barrier 32) can be positioned in a vertical configuration rather than, for example, the horizontal configuration shown in Figures 3A to 3F. For example, the support surface 104 can be positioned at approximately 90 degrees (or any other suitable angle) from the horizontal plane (e.g., rotated 90 degrees around the long axis of the support surface 104 (e.g., the longitudinal axis A1 shown in Figure 3C) relative to the embodiments shown in Figures 3A to 3F). The vertical configuration can provide easier interaction with the drive system 18 by the physician. The vertical configuration can also provide the lower axis of catheter travel closer to the patient without adding standoff height to the drive system 18.

[0069] In some embodiments, the drive system 18 can be positioned at a predetermined angle to the horizontal plane to facilitate fluid drainage during part or all of the intervention procedure. For example, the drive system 18 can be constructed or positioned in an angled configuration to facilitate fluid drainage (e.g., one lateral side of the planar support surface is positioned higher than the other lateral side of the planar support surface, with the proximal end higher than the distal end, or the distal end being higher than the proximal end). Alternatively or additionally, the drive mechanism can temporarily tilt the drive system 18 to facilitate fluid drainage (e.g., one lateral side of the drive system 18 is positioned higher than the other lateral side of the drive system 18, with the proximal end higher than the distal end, or the distal end being higher than the proximal end). For example, the drive mechanism can raise or lower one lateral side of the system 18, the proximal end of the drive system 18, and / or the distal end of the drive system 18. In some embodiments, the drive system 18 can be angled so that it extends at a predetermined angle away from the access point 24 (for example, so that the proximal end is higher than the distal end), for example, to allow clearance for the patient's foot.

[0070] Referring to Figure 4, the hub 36 can represent any of the previously described hubs. The hub 36 includes a housing 38, which extends between a proximal end 40 and a distal end 42. An intervention device 44 (which can be any of the intervention devices disclosed herein) extends distally from the hub 36 into the patient 14 (not shown). The hub adapter 48 or carriage acts as a shuttle by advancing proximal or distal along a track in response to operator commands or controller operations. The hub adapter 48 includes at least one drive magnet 67, which is configured to be coupled with a driven magnet 69 carried by the hub 36. This provides a magnetic coupling between the drive magnet 67 and the driven magnet 69 through the sterile barrier, so that the hub 36 moves across the top of the sterile barrier 32 in response to the movement of the hub adapter 48 outside the sterile field. The movement of the hub adapter is driven by a drive system supported by a support table, which is described in further detail below. The hub adapter can act as a robotic drive for the intervention device connected to it.

[0071] To reduce friction within the system, the hub 36 may be provided with at least a first roller 53 and a second roller 55, which may be in the form of wheels or rotatable balls or drums. The rollers position a sterile barrier at a distance of at least about 0.02 centimeters (about 0.008 inches) and generally no more than about 0.08 centimeters (about 0.03 inches) from the surface of the driven magnet 69. In some implementations, the space is in the range of about 0.03 centimeters (about 0.010 inches) to about 0.041 centimeters (about 0.016 inches). The space between the driving magnet 67 and the driven magnet 69 is generally no more than about 0.38 centimeters (about 0.15 inches), and in some implementations, it is no more than about 0.254 centimeters (about 0.10 inches), for example, in the range of about 0.216 centimeters (about 0.085 inches) to about 0.229 centimeters (about 0.090 inches). The hub adapter 48 may also be provided with at least a first hub adapter roller 59 and a second hub adapter roller 63, which can be positioned opposite the respective first roller 53 and second roller 55, as illustrated in Figure 4.

[0072] Referring to Figure 6, one example of a low-profile linear-driven support table 20 is schematically illustrated. The support table 20 includes an elongated frame 51 extending between a proximal end 52 and a distal end 54. At least one support table support 56 is provided to stabilize the support table 20 with respect to a patient (not shown). The support 56 may include one or more legs or preferably an articulated arm, which is configured to allow movement and positioning of the frame 51 on or adjacent to the patient.

[0073] One example of the linear drive table 20 illustrated in Figure 7 includes three separate drive units. However, two or more drive units (e.g., up to eight drive units) may be included depending on the desired clinical performance. A first drive pulley 58 engages with a first drive belt 60. A first carriage bracket 61 is fixed to the first drive belt 60 so that the rotation of the first drive pulley 58 causes the first drive belt 60 to rotate through an elongated closed-loop path. The first carriage bracket 61 can be advanced proximal or distal along the longitudinal axis of the support table 20 (e.g., longitudinal axis A2 shown in Figure 7) depending on the direction of rotation of the drive pulley 58. In the illustrated implementation, 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.

[0074] A second drive pulley 64 can engage with a second drive belt 66, which is configured to move a second carriage bracket 68 axially along an axial path on the support table 20. A third drive pulley 70 can be configured to drive a third drive belt 72 to advance a third carriage bracket 73 axially along the support table 20. Each of the carriage brackets may be provided with a drive magnet assembly, not shown in Figure 7 but previously discussed, to form a coupler for magnetically connecting to a corresponding driven magnet in the hub of the intervention device, as discussed.

[0075] A schematic diagram of the drive system is shown in Figure 8. The drive support 74 can be supported by a frame 51 for supporting the drive assembly. The second drive pulley 64 is shown in elevation section to be driven rotationally by a motor 75 via a rotatable shaft 76. The rotatable shaft 76 can be rotatably supported by the support 74 via a first bearing 78, a shaft coupling 80, and a second bearing 79. The motor 75 can be stabilized by a motor bracket 82 connected to the drive support 74 and / or the frame 51. Belt drive assemblies for the first drive belt 60 and the third drive belt 72 can be constructed similarly and are not further detailed herein. In some embodiments, the drive system described herein can be a foldable rack and pinion drive table system. In such embodiments, the motor 75 can be mounted on a carriage and moved with the carriage.

[0076] Referring to Figures 9 and 10, the first, second, and third drive belts each extend around the corresponding first idler pulley 84, second idler pulley 86, and third idler pulley 88. Each idler pulley may be provided with a corresponding tensioning bracket 90, which is configured to adjust the idler pulley proximal or distal to adjust the tension of the respective belt. Thus, each tensioning bracket 90 is provided with a tensioning adjustment unit 92, such as a rotatable screw.

[0077] As can be seen in Figure 10, the second idler pulley 86 can be supported, for example, by a rotatable shaft 94, which is rotatably fixed to the mounting bracket by a first bearing 96 and a second bearing 98.

[0078] For example, any of the catheters illustrated in Figure 5A, Figure 5B, or Figure 11 generally include 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 in the area of ​​approximately 90 centimeters to over 195 centimeters are typical for use in percutaneous transtubular coronal applications with femoral access. Intracranial or other applications may require different catheter shaft lengths depending on the site of vascular access.

[0079] Any of the catheters disclosed herein may be provided with an inclined distal tip. Referring to Figure 11, the distal catheter tip 1150 includes a tubular body 1152, which includes an advancing segment 1154, a marker band 1156, and a proximal segment 1158. An inner tubular liner 1160 may extend throughout the entire length of the distal catheter tip 1150 and may include dipped-coated or extruded PTFE or other lubricating material.

[0080] Reinforcement elements 1162, such as braids and / or spring coils, are embedded within an outer jacket 1164 that can extend along the entire length of the catheter.

[0081] The forward segment 1154 terminates distally at the angled surface 1166 and provides a leading sidewall portion 1168 having a length measured between the distal end 130 and the distal tip 1172 of the marker band 1156. In some embodiments, the entire distal tip can be shaped to avoid the tip catching in the area of ​​arterial bifurcation. The trailing sidewall portion 1174 of the forward segment 1154 has an axial length approximately equal to the axial length of the leading sidewall portion 1168 when measured approximately 180 degrees around the catheter from the leading sidewall portion 1168 in the illustrated embodiment. The leading sidewall portion 1168 can have an axial length in the range of about 0.1 mm to about 5 mm, and generally in the range of about 1 mm to 3 mm. The trailing sidewall portion 1174 can be equal to the axial length of the leading sidewall portion 1168, or at least about 0.1, 0.5, 1 millimeter, 2 millimeters, or more, depending on the desired performance.

[0082] The angled surface 1166 is inclined at an angle A ranging from approximately 45 to 80 degrees from the longitudinal axis of the catheter (represented by A3 in Figure 11). For a particular implementation, the angle ranges from approximately 55 to 65 degrees from the longitudinal axis of the catheter (e.g., longitudinal axis A3 shown in Figure 11). In one implementation, angle A is approximately 60 degrees. One consequence of an angle A less than 90 degrees is that the principal axis of the distal port area is elongated, which can increase the surface area of ​​the port and enhance blood clot aspiration or retention. Compared to the surface area of ​​a circular port (angle A is 90 degrees), the area of ​​an angled port is generally at least approximately 105 percent and no more than approximately 130 percent, and in some implementations, it ranges from approximately 110 percent to approximately 125 percent, in one example being approximately 115 percent of the area of ​​the corresponding circular port (angle A is 90 degrees).

[0083] In the illustrated embodiment, the axial length of the forward segment is substantially constant around the periphery of the catheter, and the angled surface 1166 is approximately parallel to the distal surface 1176 of the marker band 1156. The marker band 1156 has a proximal surface that is approximately transverse with respect to the longitudinal axis of the catheter, creating a marker band 1156 that has a right-angled trapezoidal configuration in the side view. The short sidewall portion 1178 is rotationally aligned with the trailing sidewall portion 1174 and has an axial length in the range of about 0.2 mm to about 4 mm, typically having an axial length of about 0.5 mm to about 2 mm. The opposing long sidewall portion 1180 is rotationally aligned with the leading sidewall portion 1168. The longer sidewall portion 1180 of the marker band 1156 is generally at least about 10 percent or 20 percent longer than the shorter sidewall portion 1178, and can be at least about 50 percent, 70 percent, 90 percent or more longer than the shorter sidewall portion 1178, depending on the desired performance. Generally, the longer sidewall portion 1180 will have a length of at least about 0.5 millimeters or 1 millimeter and less than about 5 millimeters or less than 4 millimeters.

[0084] The marker band can be a continuous annular structure, or it can have at least one and optionally two, three, or more axially extending slits throughout its entire length. The slits can be positioned on or between the short sidewalls 1178 or the long sidewalls 1180, depending on the desired bending properties. The marker band can contain any of a variety of radiopaque materials, such as a platinum / iridium alloy, and the wall thickness is preferably about 0.003 inches or less, and about 0.001 inches in one implementation configuration.

[0085] The fluoroscopic appearance of the marker bands can be unique or distinct for each catheter size or type when multiple catheters are used, and the marker bands can be distinguished from one another by a software algorithm. Distinguishing the marker bands of multiple catheters can be advantageous when multiple catheters are used together, for example, in a multi-catheter assembly or stack as described herein. In some embodiments, the catheter marker bands can be configured so that a software algorithm can detect the movement of the catheter tip.

[0086] The marker band zone of the assembled catheter can have relatively high flexural stiffness and high crush strength (e.g., at least about 50 percent or at least about 100 percent lower than the proximal segment 18, but no more than about 200 percent lower than the proximal segment 1158). High crush strength can provide radial support to the adjacent forward segment 1154, particularly to the leading sidewall portion 1168, facilitating the distal tip 1172 to function as a non-traumatic bumper during transcatheter advancement and resist collapse under vacuum. The proximal segment 1158 preferably has lower flexural stiffness than the marker band zone, and the forward segment 1154 preferably has lower flexural stiffness and even lower crush strength than the proximal segment 1158.

[0087] The forward segment 1154 may include a distal extension of the outer tubular jacket 1164 and optionally an inner liner 1160 without providing any other internal support structure distal to the marker band 1156. The outer jacket 1164 may include extruded polyurethane such as Tecothane®. The forward segment 1154 may have bending stiffness and radial crush stiffness of about 50 percent or less than the corresponding values ​​of the proximal segment 1158, and in some implementations, about 25 percent or less, or 15 percent or less, or 5 percent or less.

[0088] The catheter may further include axial tension elements or supports, such as ribbons or one or more filaments or fibers, for increasing tensile resistance and / or influencing the bending properties in the distal zone. The tension supports may include one or more axially extending monostrand or multistrand filaments. One or more tension elements 1182 may be axially positioned inside the catheter wall near the distal end of the catheter. One or more tension elements 1182 may function as tension supports and resist detachment or stretching of the tip of the catheter wall under tension (for example, when the catheter is being retracted proximally through a twisted outer catheter or a winding or narrowed vascular system).

[0089] At least one of the one or more tension elements 1182 can extend proximal along the length of the catheter wall from within about 1.0 centimeter from the distal end of the catheter to less than about 10 centimeters from the distal end of the catheter, less than about 20 centimeters from the distal end of the catheter, less than about 30 centimeters from the distal end of the catheter, less than about 40 centimeters from the distal end of the catheter, or less than about 50 centimeters from the distal end of the catheter.

[0090] One or more tension elements 1182 may have a length greater than or equal to about 40 centimeters, a length greater than or equal to about 30 centimeters, a length greater than or equal to about 20 centimeters, a length greater than or equal to about 10 centimeters, or a length greater than or equal to about 5 centimeters.

[0091] At least one of the one or more tension elements 1182 may extend to at least approximately 50 centimeters at the distal end of the catheter length, at least approximately 40 centimeters at the distal end of the catheter length, or at least approximately 30 centimeters, 20 centimeters, or 10 centimeters at the distal end of the catheter length.

[0092] In some implementations, the tension element extends proximal from the distal end of the catheter along the length of the coil 24 and terminates proximal within approximately 5 centimeters or less than 2 centimeters on either side of the transition between the distal coil and the proximal braid. The tension element can terminate at the transition without overlapping with the braid.

[0093] One or more tension elements 1182 can be positioned near the inner liner 1160 or radially outward from it. One or more tension elements 1182 can be positioned near the braid and / or coil or radially inward from it. One or more tension elements 1182 can be supported between the inner liner 1160 and the helical coil and can be fixed to the surface of the inner liner or other underlying layer by adhesive before the addition of the next adjacent outer layer, such as the coil. Preferably, the tension elements 1182 are fixed to the marker band 1156 by adhesive or by mechanical interference. In one implementation configuration, the tension elements 1182 extend distally beyond the marker band on a first (e.g., inner) surface of the marker band, then wrap around the distal end of the marker band, extend along a second (e.g., outer) surface in either or both of the proximal inclined direction or the circumferential direction, and wrap completely around the marker band.

[0094] When two or more tension elements 1182 or filament bundles are arranged circumferentially within the catheter wall at a distance from each other, the tension elements 1182 can be arranged in a radially symmetrical manner. For example, the angle between two tension elements 1182 with respect to the radial center of the catheter can be about 180 degrees. Alternatively, depending on the desired clinical performance (e.g., flexibility, traceability), the tension elements 1182 can be arranged in a radially asymmetrical manner. The angle between any two tension elements 1182 with respect 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.

[0095] One or more tension elements 1182 may include materials such as Vectran®, Kevlar®, Polyester®, Spectra®, Dyneema®, Meta-Para-Aramide®, or any combination thereof. At least one of the one or more tension elements 1182 may include a single fiber or a multi-fiber bundle, and the fiber or bundle may have a round or rectangular (e.g., ribbon) cross-section. The terms fiber or filament do not convey composition, and they may include any of a variety of high-tensile strength polymers, metals, or alloys, depending on design considerations such as desired tensile fracture limit and wall thickness. The cross-sectional dimensions of one or more tension elements 1182 may be about 2 percent or less, 5 percent or less, 8 percent or less, 15 percent or less, or 20 percent or less of those of the catheter 10 when measured radially.

[0096] The cross-sectional dimensions of one or more tension elements 1182 can be approximately 0.03 mm (approximately 0.001 inches) or less, approximately 0.0508 mm (approximately 0.002 inches) or less, approximately 0.1 mm (approximately 0.004 inches) or less, approximately 0.15 mm (approximately 0.006 inches) or less, approximately 0.2 mm (approximately 0.008 inches) or less, or approximately 0.38 mm (approximately 0.015 inches) or less when measured radially.

[0097] One or more tension elements 1182 can increase the tensile strength of the distal zone 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 failure under tension (e.g., marker band detachment).

[0098] Depending on the desired data, various sensors can be provided on either the catheter, hub, carriage, or table. For example, in some implementations, it may be desirable to measure axial tension or compressive force applied to the catheter, for example, along a force sensing zone. The distal end of the catheter will be made in a similar construction as illustrated in Figure 11, with a distal section of helical coils. However, instead of using a single helical coil of nitinol wire, the first conductor 140 and the second conductor 142 are wound to form an intertwined helical coil and electrically isolated from each other, for example, by plastic / resin in the tubular body. See Figure 12A. Each coil is electrically connected to the proximal hub by an intrinsic electrical conductor, such as a conductive trace or a proximal extension of the wire.

[0099] This construction of two electrically isolated helical coils generates a capacitor. This is roughly equivalent to two plates of Nitinol with a plastic layer between them, illustrated in Figure 12B. The capacitance is inversely proportional to the distance between the wires. The only variable that will change is d (distance between the plates). When an axial compressive force is applied to the catheter, the wires (e.g., conductor 140 and conductor 142) will move closer to each other, thus increasing the capacitance. When an axial tensile force is applied, the wires will move further apart, decreasing the capacitance. This capacitance can be measured at the proximal end of the catheter and gives a measurement of the force in the helical capacitor. Although referred to as a capacitor, this sensor measures the electrical interaction between the two coils of wire. Due to the applied axial force, there may be a measurable change in inductance, or a change resulting from other circumstances.

[0100] At least the first helical capacitor may have at least one, five, ten, or more complete rotations of each wire. The capacitor may be positioned within 5, 10, or 20 centimeters of the distal end of the catheter body to detect the force acting at the distal end. At least the second capacitor may be provided within 5, 10, or 20 centimeters of the nearest end of the catheter body to detect the force acting at the proximal end of the catheter.

[0101] Furthermore, to measure the force applied to the hub, it may also be desirable to measure the elastic force across the magnetic connection between the hub and the corresponding carriage, using the natural springiness (compliance) of the magnetic connection. The magnetic connection between the hub and carriage generates a spring. When a force is applied to the hub, the hub will move a small amount relative to the carriage. See Figure 13A. In robotics, this is called a series elastic actuator. This property can be used to measure the force applied from the carriage to the hub. To measure the force, the relative distance between the hub and carriage (dx shown in Figure 13A) is determined and a certain effective spring constant k between the two components is characterized. See Figure 13B.

[0102] Relative distance can be measured in several different ways. One method for measuring the relative distance between a hub and a carriage is using magnetic sensors (e.g., Hall effect sensors between the hub and the carriage). A magnet is mounted on either the hub or the carriage, and a corresponding magnetic sensor is mounted on the other device (carriage or hub). The magnetic sensor can be a Hall effect sensor, a magnetoresistive sensor, or another type of magnetic field sensor. Generally, multiple sensors can be used to increase the reliability of the measurement. This reduces noise and interference from external magnetic fields.

[0103] Other non-contact distance sensors may also be used. These include optical sensors, inductance sensors, and capacitance sensors. Optical sensors are preferably configured in a manner that avoids the accumulation of blood or other fluids at the interface between the hub and the carriage. In some implementations, wireless (i.e., inductive) power may be used, for example, to convert motion across the sterile barrier between the drive carriage and the hub and / or to transfer information.

[0104] The magnetic connection between the hub and carriage has a shear or axial fracture threshold, which can be approximately 300 grams or 1000 grams or more. The processor can be configured to compare the axial force applied to the catheter with a preset axial trigger force that, if applied to the catheter, is perceived to create a risk to the patient. If the trigger force is reached, the processor can be configured to generate a response to the physician, such as visual, auditory, or tactile feedback, and / or to delay and stop further advancement of the catheter until a reset is achieved. Override features can be provided, so that the physician can choose to continue advancing the catheter at a force higher than the trigger force in situations where the physician believes incremental force is justified.

[0105] Force and / or torque sensing optical fibers (e.g., fiber Bragg grating (FBG) sensors) can be incorporated into the catheter sidewall to measure force and / or torque at various locations along the catheter shaft, or alternatively, integrated into the guidewire. The fiber can measure axial strain, which can be converted into axial force or torque (when wound spirally). At least a first FBG sensor can be integrated into distal sensing zones, proximal sensing zones, and / or intermediate sensing zones on the catheter or guidewire to measure force and / or torque near the sensor.

[0106] Furthermore, it may be desirable to understand the three-dimensional configuration of the catheter or guidewire during and / or following transvascular placement. Shape-sensing optical fibers, such as arrays of FBG fibers, are used to detect the shape of the catheter and guidewire. By using multiple force-sensing fibers at known distances from each other, it is possible to determine the shape along the length of the catheter / guidewire.

[0107] A resistance strain gauge can be integrated into the catheter body or guidewire to measure force or torque. For example, it may be located at the distal and / or proximal end of the device.

[0108] Measurements of the force and / or torque applied to the catheter or guidewire shaft can be used to determine applied forces and / or torques that exceed a safety threshold. When the applied force and / or torque exceeds the safety threshold, a warning can be provided to the user. Furthermore, the applied force and / or torque measurements can be used to provide feedback related to better catheter manipulation and control. Additionally, the applied force and / or torque measurements can be used in conjunction with processed fluoroscopic imaging information to determine or characterize distal tip motion.

[0109] The absolute position of the hub (and corresponding catheter) along the length of the table can be determined in various ways. For example, a non-contact magnetic sensor can be configured to directly measure the position of the hub through a sterile barrier. Alternatively, the same type of sensor can be configured to measure the position of the carriage. Each hub can have at least one magnet attached to it. The robotic table will have a linear array of corresponding magnetic sensors along the entire length of the table. A processor can be configured to determine the position of the magnets along the length of the linear sensor array and to display the axial position information to the physician.

[0110] The aforementioned methods can, alternatively, be achieved using non-contact inductive sensors to directly measure the position of the hub through a sterile barrier. Each hub or carriage can be provided with an inductive "target" within it. A robotic table can be provided with an inductive sensing array along the entire working length of the table. As a further alternative, an absolute linear encoder can be used to directly measure the linear position of the hub or carriage. The encoder can use any of a variety of different techniques, including optical, magnetic, inductive, and capacitive methods.

[0111] In one implementation configuration, passive (non-electrically connected) target coils can be supported by their respective hubs. A linear printed circuit board (PCB) can run along the entire working length of a table (e.g., at least about 1.5 meters to about 1.9 meters) configured to ping an interrogator signal that stimulates the return signal from the passive coil. The PCB is configured to identify the return signal and its location.

[0112] The axial position of the carriage can be determined using a multi-turn rotary encoder to measure the rotational position of the pulley, and the rotational position of the pulley is directly correlated to the linear position of the carriage. Alternatively, direct measurement of the carriage position can be achieved by recording the number of steps commanded to a stepper motor to measure the rotational position of the pulley, and the rotational position of the pulley is directly correlated to the linear position of the carriage.

[0113] Furthermore, the location of the catheter and guidewire within anatomical structures can also be determined by processing fluoroscopic images with machine vision, for example, to determine the distal tip position, distal tip orientation, and / or guidewire shape. Comparing the distal tip position or movement, or absence thereof, with the commanded or actual proximal catheter or guidewire movement in the hub can be used to detect loss of relative motion, which can indicate buckling, dislocation, twisting, or similar results of the device shaft (e.g., along the device shaft length inside the body (e.g., in the aorta) or outside the body between hubs). Processing can be done in real time to provide position / orientation data at up to 30 Hz, although this technique will only provide data while fluoroscopic imaging is turned on. In some embodiments, machine vision algorithms can be used to generate and suggest optimal catheter maneuvers to access or reach anatomical landmarks, as well as driver assistance. Machine vision algorithms can utilize data to automatically drive the catheter in accordance with the anatomical structures presented by fluoroscopy.

[0114] The proximal torque applied to the catheter or guidewire shaft can be determined using a dual encoder torque sensor. Referring to Figure 14, a first encoder 144 and a second encoder 146 can be positioned axially spaced along the shaft 148 to measure the difference in angle over the length of the flexible catheter / tube. The difference in angle is interpolated as torque, since the catheter / tube has known torsional stiffness. When torque is applied to the shaft, the slightly flexible portion of the shaft will twist. The torque can be determined from the difference (dθ) between the angles measured by the encoders: T = k * dθ, where k is the torsional stiffness.

[0115] Furthermore, confirming the absence of bubbles in a fluid line can be achieved using a bubble sensor, particularly when the physician is remote from the patient. This can be achieved using a non-contact ultrasonic sensor, which measures the intensity and Doppler shift of reflected ultrasound through the sidewall of the fluid tubing to detect bubbles and measure the fluid flow rate or fluid level. The ultrasonic or optical sensor can be positioned adjacent to the inflow fluid channel in the hub or in the supply line connected to the hub. To detect the presence of air bubbles in an infusion line (which is formed from an ultrasonically or optically permeable material), the sensor can include a signal source on a first side of the channel and a receiver on a second side of the channel to measure the transmittance through the liquid passing through the tube to detect the bubbles. Alternatively, the reflected ultrasonic signal can be detected from the same side of the channel as the source, due to the relatively high echobrightness of the bubbles.

[0116] Preferably, the bubble removal system is automatically activated when bubbles are detected in the line. The processor can be configured to activate a valve positioned in the flow path downstream of the bubble detector when bubbles are detected. The valve redirects the column of fluid from the flow path to the patient into a reservoir. When no more bubbles are detected in the flow path, and after the volume of fluid in the flow path between the detector and the valve has passed through the valve, the valve can be activated to reconnect the fluid source to the patient through the flow path. In other embodiments, the bubble removal system can include a pump and control system upstream of the bubble detector for removing bubbles in the line. The processor can be configured to activate the pump when bubbles are detected, reverse the fluid flow, and remove the bubbles into a waste reservoir before re-establishing a bubble-free forward flow.

[0117] Additionally, it may be desirable for a physician to be able to view the aspirated blood clot at a predetermined location within a sterile field, and preferably as close to the patient as is practical for fluid management purposes. This can be achieved by providing a blood clot recovery device that is mounted on a hub or in a suction line leading away from the hub towards the pump. Referring to Figure 15, one example of a blood clot recovery device 370 may include a body 380 surrounding a chamber 381 communicating with a first port 310 and a second port 320.

[0118] In some embodiments, the main body 380 includes a housing having an upper portion 382 and a bottom portion 384. The main body 380 may include a filter 330, which is positioned in the chamber 381 between the upper portion 382 and the bottom portion 384. In some examples, the first port 310 is configured to connect to the first end of the first tube 340, which is fluidly connected to the proximal end of the suction catheter.

[0119] In embodiments configured to connect downstream from a hub, the first tube 340 includes a connector 342 located at a second end of the first tube 340, which is configured to engage with or mate with a corresponding connector on or communicating with the hub. A first port 310 communicates directly with the chamber upstream of the filter (e.g., the top side), and a second port 320 communicates directly with the chamber downstream of the filter (e.g., the bottom side), facilitating direct visualization of the material trapped upstream of the filter.

[0120] In implementations configured for remote operation, various sensors may be provided to detect blood clots passing through the suction line and / or trapped in the filter, such as optical sensors, pressure sensors, flow sensors, ultrasonic sensors, or others known in the art.

[0121] In some embodiments, the second port 320 is configured to connect to the first end of a second tube 350 which is fluidly connected to a suction supply source (e.g., a pump). In some embodiments, the second tube 350 includes a connector 352, which is positioned at the second end of the second tube 350 and is configured to engage or mate with a corresponding connector on the pump.

[0122] In some examples, the system 300 may include an on / off valve 360, such as a clamp 360. The clamp 360 may be positioned between the filter 330 and the patient (e.g., over the first tube 340) to allow a user to engage the clamp and to provide flow control by isolating the patient from the blood clot recovery device 370. Closing the valve 360 ​​and operating a remote vacuum pump (not shown) causes the vacuum pump and the canister associated with the chamber 381 to reach the same low pressure. Due to the short lumen distance and small line volume between the chamber 381 and the distal end of the catheter, a sharp negative pressure spike is received at the distal end of the catheter, rapidly following the opening of the valve 360. Additional details are disclosed in U.S. Patent No. 11,259,821, titled “Aspiration System with Accelerated Response,” issued to Buck et al. on 1 March 2022, which is expressly incorporated herein by reference. In some embodiments, a vacuum can be circulated over the blood clot to recover it. The vacuum can be controlled automatically and robotically to remove the blood clot.

[0123] The main body 380 may have an upper surface that is spaced apart from the bottom surface by tubular side walls. In the illustrated configuration, the upper and bottom surfaces are substantially circular and spaced apart by cylindrical side walls. The upper surface may have a diameter at least about 3 or 5 times or more the axial length of the side walls (transverse to the upper and bottom surfaces) to create a generally disk-shaped housing. Preferably, at least a portion of the upper wall is optically transparent to improve blood clot visibility when a blood clot is captured in the blood clot recovery device 370. Additional details can be found in U.S. Patent Application No. 63 / 256,743, which in whole is expressly incorporated herein by reference.

[0124] In some examples, the main body 380 may include a flush port (not shown) configured to allow the injection of an optically transparent medium (e.g., air, saline solution, or other fluid) into the chamber 381, clearing the optical path between the window and the filter to improve blood clot visualization once a blood clot is trapped in the filter 330.

[0125] The foregoing describes specific and concrete implementations of the drive table and related components and catheter. As those skilled in the art will recognize in light of the disclosure herein, a wide variety of different drive table constructions are possible to support and axially advance and retract two, three, four or more drive magnet assemblies for robotically driving intervention devices, fluid elements, and electrical umbilical elements for transmitting electrical signals and fluids to the catheter hub. Further details can be found in U.S. Patent Application No. 17 / 527,393, which is expressly incorporated herein by reference in its entirety.

[0126] While the foregoing describes intervention devices driven by robotic control and manually driven intervention devices, the devices can be manually driven, robotic controlled, or a combination of both, as will be apparent to those skilled in the art in light of the disclosure herein.

[0127] Figures 16A–16C illustrate exemplary control mechanisms 2200 for operating intervention devices driven by (or otherwise associated with) each hub. For example, each hub can be operated and / or otherwise moved using at least one control unit located within the control mechanism 2200. Each control unit can be adapted to move its own hub and associated intervention device during an intervention procedure.

[0128] As shown in Figure 16A, the control mechanism 2200 includes a first control unit 2202, a second control unit 2204, a third control unit 2206, and a fourth control unit 2208. Depending on the intended intervention device configuration, more or fewer control units may be provided. Each of the control units 2202-2208 is movably mounted on a shaft 2210, which is connected to a distal bracket 2212 and a proximal bracket 2214. The control units 2202-2208 can advance distally or retract proximal on the shaft 2210, as indicated by arrows 2218 and 2216. In addition, each of the control units 2202-2208 can also be rotated around the shaft 2210, as indicated by arrow 2220. The movement of each control unit can trigger a responsive movement in the corresponding carriage on the support table, which in turn can drive the movement of the corresponding hub, as has been discussed.

[0129] The control mechanism 2200 can be positioned on or near a patient support table having a set of hubs and catheter / intervention devices. In some implementations, the control mechanism 2200 can be positioned remotely from the support table, for example, behind a radiation shield in a telemedicine implementation, or in a different room or geographical location.

[0130] Each of the control units 2202-2208 is capable of responding to and driving the movement of the hub and / or combinations of the hub and intervention device. For example, control unit 2202 can be configured to drive hub 30 (Figure 3F) to move an intervention device such as a 0.088-inch guide catheter corresponding to hub 30. Similarly, control unit 2204 can be configured to drive hub 28 (122) to move an intervention device such as a 0.071-inch treatment catheter. Control unit 2206 can be configured to drive hub 126 to move an intervention device such as a maneuverable access catheter. Control unit 2208 can be configured to drive hub 26 to move an intervention device such as a guidewire in the axial and rotational directions.

[0131] Figure 16B illustrates an example of manually operating the control unit 2202 on the control mechanism 2200. When the user 2230 moves the control unit 2202 axially and distally along the shaft 2210, as indicated by arrow 2232, the corresponding connected hub and / or intervention device can move in the same direction in response by the same amount or a scaled amount. When the user 2230 rotates the control unit 2202 around the shaft 2210 and moves the control unit proximal, as indicated by arrow 2234, the corresponding connected intervention device will move in the rotational and proximal direction in response by the same amount or a scaled amount. When the user 2230 moves the control unit 2202 rotationally around the shaft 2210, as indicated by arrow 2236 or arrow 2238, the corresponding connected hub will drive the corresponding intervention device rotationally in the same direction and / or by the same amount or a scaled amount.

[0132] Other axes and degrees of freedom can be defined to enable the control unit 2202 to perform movements that can be converted into movement of the hub and / or intervention device. For example, the control mechanism may be provided with one or more deflection control units, each configured to initiate lateral deflection within a deflection zone on the corresponding intervention device.

[0133] The axial movement of the control unit can be configured to move the connected hub on a 1:1 base or on a non-1:1 scaled base. For example, if user 2230 advances the control unit 2022 distally along shaft 2210 by approximately 5 millimeters, the corresponding hub can respond by moving 5 millimeters distally.

[0134] If user 2230 rotates the control unit 2022 by 5 degrees around its axis of rotation (represented by A4 in Figure 16B), the connected hub will rotate the corresponding intervention device on a 1:1 basis or on a non-1:1 scaled basis. The scaling amount can be selected to reduce or increase the distance and rotation amount by which the hub and / or intervention device move in accordance with the movement of the control unit.

[0135] In some implementations, the scaled quantities described herein can be determined using a scale factor. The scale factor can be applied to either or both translational and rotational movements. In some implementations, a first scale factor is selected with respect to translational movement, and a second scale factor, different from the first scale factor, is selected with respect to rotational movement. The axial scaling factor can drive proximal catheter movement at a faster rate than distal catheter movement with respect to a given proximal or distal operation of the control unit.

[0136] The rotational scale factor can be 1:1, while the axial scale factor allows the hub to move a greater distance than the movement of the control unit, so that, depending on the desired axial length of the control assembly, the hub travel relative to the control unit travel is at least about 2:1, 5:1, 10:1, or greater.

[0137] The control mechanism 2200 can be configured to allow clinicians to adjust the scale factor with respect to different parts of the procedure. For example, distal advancement of the procedure catheter and access catheter through the guide catheter and to the selected orifice can preferably be achieved in "high-speed" mode. However, more distal travel into the neurovascular system can preferably be achieved in a relatively slow mode by operating the speed control.

[0138] In another implementation, one or more control units can be configured to gradually drive the forward or backward speed of the corresponding hub and associated catheter. For example, a distal control unit 2202 can drive the guide catheter. A slight distal movement of the control unit 2202 can cause the guide catheter to advance distally at a slow speed, while advancing the control unit 2202 distally by a greater distance increases the rate of distal travel of the guide catheter.

[0139] Controlling the speed of the corresponding hub in either the axial direction or both the axial and rotational directions can enhance the overall speed of the procedure. For example, the advancement of various devices from the femoral access point to the aortic arch can preferably be achieved at a faster rate than more distal navigation closer to the treatment site. Similarly, the proximal retracement of various devices (in particular guidewires, access catheters, and treatment catheters) can preferably be achieved at a relatively higher speed than distal advancement.

[0140] Figure 16C illustrates another example of manually operating the control units on the control mechanism 2200 to move the hub and / or other intervention devices. In some implementations, two or more control units 2202-2208 can be moved in combination to trigger the movement of one or more hubs and / or related intervention devices. In the example depicted, user 2230 moves control units 2204 and 2206 in combination (e.g., sequentially, simultaneously) to move, for example, a 0.088 guide catheter and a 0.071 suction catheter as a single unit simultaneously. Exemplary movement of control unit 2204 can include axial proximal movement in the direction indicated by arrow 2250. Sequentially or simultaneously, user 2230 can move control unit 2206 axially in either the direction indicated by arrows 2254 and 2256, and simultaneously move control unit 2206 rotationally in either the direction indicated by arrows 2258 and 2260.

[0141] In some implementations, each control mechanism and / or additional control unit (not shown) can be color-coded, shape-coded, tactilely coded, or otherwise distinguished to indicate to the user 2230 which color is configured to move which hub or intervention device. In some implementations, the color coding of the control units can also be applied to the hubs and / or intervention devices, allowing the user to visually match a particular hub / device with a particular control unit.

[0142] In some implementations, control operations other than translational and rotational movement can be performed using control units 2202-2208. For example, control units 2202-2208 can be configured to drive shape changes and / or stiffness changes of the corresponding intervention device. Control units 2202-2208 can be switched between different operating modes. For example, control units 2202-2208 can be switched between movement driven by acceleration and velocity and movement that reflects actual linear displacement or rotation.

[0143] In some implementations, the control mechanism 2200 may be provided with a visual display or other indicator of the relative position of the control unit that can correspond to the relative position of the intervention device. Such a display may depict any or all directions of movement, commands, percentages of movement performed, and / or hub and / or catheter indicators to indicate which device is controlled by a particular control unit. In some implementations, the display may depict the applied force or resistance encountered by the catheter, or other measurements detected or observed by a particular hub or intervention component.

[0144] In some implementations, the control mechanism 2200 may include tactile components to provide tactile feedback to the user operating the control unit. For example, if the control unit 2202 is triggering catheter movement and the catheter detects a large force at its tip, the control unit 2202 may generate tactile feedback to indicate to the user that the movement be stopped or reversed. In some implementations, tactile feedback may be generated in the control unit to indicate to the user that the control unit should be used to slow down or speed up the movement. In some implementations, tactile feedback may be provided regarding the accumulation of large torsional strains that may precede abrupt rotation, or the accumulation of large axial forces that may foreshadow catheter buckling.

[0145] The system described herein allows for the comparison of the actual fluoroscopic image position with the input displacement from the controller. A static fluoroscopic image of the patient can be captured, in which the patient's vascular system is indexed against bone landmarks or one or more implanted soft tissue reference markers. A real-time fluoroscopic image can then be displayed as an overlay, which is aligned with the static image by the alignment of the reference markers. Visual observation of the fit of real-time movement with the static image, supported by detected force data, can help confirm proper 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 distal tip output motion or lack thereof. Loss of relative motion at the distal tip can indicate shaft buckling, dislocation, torsion, or similar consequences either medially or laterally to the main body. Such comparisons may be useful when shaft buckling, dislocation, torsion, or similar consequences occur outside the current fluoroscopic field of view.

[0146] Figure 17 illustrates a schematic side view of the multi-catheter intervention device assembly 2900 for combined superior aortic access and / or neurovascular site access and treatment (e.g., aspiration), as described herein. The multi-catheter assembly 2900 can be configured for either manual or robotic treatment.

[0147] The intervention device assembly 2900 includes an insertion or access catheter 2902, a treatment catheter 2904, and a guide catheter 2906. However, it is not limited to other components, including one or more guidewires (e.g., a voluntary guidewire 2907), one or more guide catheters, an access sheath and / or one or more other treatment catheters, and / or an associated catheter (control) hub. In some embodiments, the assembly 2900 may also be configured to include a voluntary deflection control unit 2908 for controlling the deflection of one or more catheters in the assembly 2900.

[0148] During operation, the multi-catheter assembly 2900 can be used without the need to replace the hub components. For example, in a previously disclosed two-step procedure, the first step to achieve superior aortic access includes mounting the access catheter, guide catheter, and guidewire to a support table. Once superior aortic access is achieved, the access catheter and guidewire are typically removed from the guide catheter. The second catheter assembly is then introduced through the guide catheter, after mounting a new guidewire hub and procedure catheter hub to the corresponding drive carriage on the support table.

[0149] The single multi-catheter assembly 2900 in Figure 17 is configured to operate without the need to remove the hub and catheter, and without the addition of additional assemblies and / or hubs. Thus, the multi-component access and treatment configuration of assembly 2900 can utilize guidewires 2907 manufactured to function as access and navigation guidewires, enabling sufficient access to and support to specific distal treatment sites, as well as navigation. In a non-limiting example configured for robotic implementation, the catheter assembly may include a guidewire hub (e.g., guidewire hub 2909, or guidewire hub 26 positioned on the drive table and to the right of catheter 2902), an insertion or access catheter hub 2910, a treatment catheter hub 2912, a guide catheter hub 2914, and the corresponding catheter. In certain embodiments, one or more of the hubs may include or be connected to a hemostatic valve (e.g., a rotary hemostatic valve) to accommodate the introduction of an intervention device through it. Further details relating to the hemostatic valve are contained in U.S. Patent Application No. 17 / 879,614, filed on 2 August 2022, entitled "Multi Catheter System With Integrated Fluidics Management," which is expressly incorporated herein by reference in its entirety.

[0150] Once access to the superior aortic arch is achieved, the insertion or access catheter 2902 (associated with the insertion or access catheter hub 2910) can be placed near the carotid orifice, and the remainder or subset of the catheter assembly can be guided more distally toward a specific site (e.g., a blood clot site, surgical site, treatment site, etc.).

[0151] In some embodiments, other smaller treatment catheters may be added and used at the site. In a robotic configuration of the assembly 2900, as used herein with respect to the catheter assembly 2900, the guide catheter 2906 can function as a guide catheter. The treatment catheter 2904 can function as a treatment (e.g., aspiration) catheter. In some embodiments, the guide catheter 2906 can function to perform aspiration in addition to functioning as a guide catheter, either in place of or in addition to the treatment catheter 2904. The access catheter 2902 may have a distal deflection zone and may function to access a desired orifice. Those skilled in the art will recognize from Figures 18A–18E that either manual or robotic operation of a multi-catheter stack is contemplated herein.

[0152] In some embodiments, the catheter assembly 2900 (or other combined catheter assemblies described herein) can be driven to a predetermined location as a single unit. However, each catheter (or guidewire) component can instead be operated and driven independently of each other to the same or different locations.

[0153] In non-limiting examples, the catheter assembly 2900 can be used for diagnostic angiography. In some embodiments, the assembly 2900 may include only the guidewire 2907 and access catheter 2902 (in the form of a diagnostic angiography catheter) for performing the diagnostic angiography, or only the guidewire 2907 and access catheter 2902 may be used during the procedure. Alternatively, the guide catheter 2906 and procedure catheter 2904 may be retracted proximal to expose the distal end of the access catheter 2902 (e.g., a few centimeters of the distal end of the access catheter) to perform the diagnostic angiography.

[0154] As shown in Figure 17, the guide catheter 2906, treatment catheter 2904, access catheter 2902, and guidewire 2907 can be arranged concentrically. In certain embodiments, the guide catheter 2906 can be a “large bore” guide catheter or access catheter having a diameter of at least about 0.075 or at least about 0.080 inches. The treatment catheter 2904 can be a suction catheter having a diameter in the range of about 0.060 inches to about 0.075 inches. The access catheter 2902 can be a maneuverable catheter with a deflectable distal tip having a diameter in the range of about 0.025 inches to about 0.050 inches. The guidewire 2907 can have a diameter in the range of about 0.014 inches to about 0.020 inches. In one example, the guide catheter 2906 may have a diameter of approximately 0.088 inches, the treatment catheter 2904 may have a diameter of approximately 0.071 inches, the access catheter 2902 may have a diameter of approximately 0.035 inches, and the guidewire 2907 may have a diameter of approximately 0.018 inches.

[0155] Figures 18A–18E illustrate an exemplary sequence of steps for introducing a multi-catheter assembly configured to achieve access to a blood clot, either manually or robotically controlled. Figures 18A–18E can also be illustrated using the intervention device assembly of Figure 17. Other combinations of catheters can be substituted for the intervention device assembly, as will be recognized by those skilled in the art in light of the disclosure herein.

[0156] Referring to Figure 18A, a three-catheter intervention device assembly 2900 is shown to be driven into the descending aorta through the iliac artery 3004 via an introducer sheath 3002. Next, the access catheter 2902, treatment catheter 2904 (e.g., 0.071 inches), and guide catheter 2906 (e.g., 0.088 inches) are tracked to the aortic arch 3006, as shown in Figure 18B. Here, the distal end of the guide catheter 2906 can be placed below the aortic arch 3006, and the treatment catheter 2904, access catheter 2902 (positioned within the treatment catheter 2904 and not visible in Figure 18B), and guidewire 2907 can be driven into the orifice (e.g., simultaneously or separately). In some embodiments, the access catheter 2902 is advanced outward from the treatment catheter 2904 and guide catheter 2906 and first engages with the orifice. After the distal end of the access catheter 2902 is positioned within the desired orifice, the guidewire 2907 can be advanced distally into the orifice to secure access. After the access catheter 2902 and guidewire 2907 are positioned within the desired orifice, the treatment catheter 2904 and / or guide catheter 2906 can be advanced into (and, in some embodiments, beyond) the orifice, using the support of the access catheter 2902 and / or guidewire 2907 to maneuver through the aorta into the orifice. In the embodiment shown in Figure 18B, the treatment catheter 2904 has been advanced into the orifice, while the guide catheter 2906 remains positioned below the aortic arch 3006.

[0157] Referring to Figure 18C, the guidewire 2907 can be advanced distally, and its radiopaqueness can be used to confirm under fluoroscopic imaging that access through the desired orifice has been achieved. The guidewire 2907 engages with the origin of the brachiocephalic artery 3014. The guidewire 2907 is then advanced to the pyramidal segment 3018 of the internal carotid artery 3016.

[0158] Referring to Figure 18D, the guide catheter 2906 and the treatment catheter 2904 (positioned within the guide catheter 2906 and not visible in Figure 18D) can both be advanced (e.g., simultaneously or sequentially) over the guidewire 2907 and over the insertion or access catheter 2902 (positioned within the treatment catheter 2904 and not visible in Figure 18D), while the access catheter 2902 remains in the orifice for support. The guidewire 2907 can be further advanced beyond the pyramidal segment 3018 to the site of the blood clot 3020, such as the M1 segment.

[0159] Referring to Figure 18E, the guide catheter 2906 and the treatment catheter 2904 (positioned within the guide catheter 2906 and not visible in Figure 18E) are advanced (e.g., simultaneously or sequentially) to position the distal tip of the treatment catheter 2904 on the treatment site (e.g., on the plane of the blood clot 3020). The guidewire 2907 and the access catheter 2902 (positioned within the treatment catheter 2904 and not visible in Figure 18E) are removed, and aspiration of the blood clot 3020 is initiated through the treatment catheter 2904. That is, the guidewire 2907 and the access catheter 2902 are retracted proximal to allow aspiration through the treatment catheter 2904. After aspiration of the blood clot, the treatment catheter 2904 and the guide catheter 2906 can be removed (e.g., simultaneously or sequentially). For example, in some embodiments, the treatment catheter 2904 can be removed before the guide catheter 2906 is removed.

[0160] The catheter assembly 2900 can be used to perform neurovascular procedures, as illustrated in Figures 18A to 18E. For example, the neurovascular procedure may be neurovascular thrombectomy. The steps of the procedure may include providing an assembly comprising at least a guidewire, an access catheter, a guide catheter, and a procedure catheter. For example, the catheter assembly 2900 includes a guidewire 2907, an access (e.g., insertion) catheter 2902, a guide catheter 2906, and at least one procedure catheter 2904. The procedure catheter 2904 may include an aspiration catheter, an embolism deployment catheter, a stent deployment catheter, a flow diverter deployment catheter, a diagnostic angiography catheter, a stent retriever catheter, a blood clot retriever catheter, a balloon catheter, a catheter for facilitating percutaneous valve repair or replacement, an ablation catheter, and / or an RF ablation catheter or guidewire.

[0161] The neurovascular procedure may further include the steps of connecting the assembly to a non-robot or robotically driven system and driving the assembly to achieve superior aortic access. The steps may further 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 procedure catheter.

[0162] Each of the guide wire 2907, access catheter 2902, guide catheter 2906, and treatment catheter 2904 is configured to be adjustable by their respective hubs. For example, the guide wire 2907 may include (or be connected to) a hub mounted on one of the tray assemblies described herein. Similarly, the access catheter 2902 may be connected to an insertion or access catheter hub 2910. The guide catheter 2906 may be connected to a guide catheter hub 2914. The treatment catheter 2904 may be connected to a treatment catheter hub 2912.

[0163] Generally, the assembly connection can include magnetically connecting a first hub, such as a guide wire hub 2909 connected to a guide wire 2907, to a first drive magnet; magnetically connecting a second hub, such as an insertion or access catheter hub 2910 connected to an access catheter 2902, to a second drive magnet; magnetically connecting a third hub, such as a treatment catheter hub 2912 connected to a treatment catheter 2904, to a third drive magnet; and magnetically connecting a fourth hub, such as a guide catheter hub 2914 connected to a guide catheter 2906, to a fourth drive magnet. Generally, the first, second, third, and fourth drive magnets are each independently movably supported by a drive table, as described with respect to the tray assembly and control unit described herein. In some embodiments, the first, second, third, and fourth drive magnets are connected (e.g., to their respective catheter hubs) through sterile barriers (e.g., sterile barriers and fluid barriers) and are independently movably supported by a drive table having multiple driven magnets. In some embodiments, two or more drive magnets can be connected together or otherwise coupled so that they move as a single unit in response to a command from a single controller connected to or otherwise coupled to one of the drive magnets.

[0164] In some implementations, the step of performing a neurovascular procedure may include driving the assembly in response to each movement of the hub adapters along a support table until the assembly is positioned to achieve superior aortic vascular access. The hub adapters may include a coupler / carriage that acts as a shuttle by advancing proximal or distal along a track in response to operator commands, for example. The hub adapters described herein may each include at least one driving magnet configured to be coupled with a driven magnet carried by the respective hub. This provides a magnetic coupling between the driving and driven magnets through a sterile barrier, so that each hub moves across the top of the sterile barrier in response to the movement of the hub adapter outside the sterile field (as described in detail in Figure 4). The movement of the hub adapters is driven by a drive system carried by a support table on which the guidewire hub 2909, guide catheter hub 2914, procedure catheter hub 2912, and insertion or access catheter hub 2910 are mounted.

[0165] The step may further include driving a subset of the assembly in response to each movement of the hub adapter along the support table until the subset of the assembly is positioned to perform a neurovascular procedure at the neurovascular treatment site. The subset of the assembly may include a guide wire 2907, a guide catheter 2906, and a treatment catheter 2904.

[0166] In some embodiments, the guidewire 2907, guide catheter 2906, and treatment catheter 2904 are advanced as a single unit through at least a portion of the length of the access (e.g., insertion) catheter 2902 (with respect to the guidewire 2907) and over it (with respect to the guide catheter 2906 and treatment catheter 2904) after superior aortic access has been achieved.

[0167] In some embodiments, the catheter assembly 2900 can be part of a robotic control system for achieving superior aortic access and neurovascular treatment site access, as illustrated in Figures 18A to 18E. In some embodiments, the catheter assembly 2900 can be part of a manual control system for achieving superior aortic access and neurovascular treatment site access. In some embodiments, the catheter assembly 2900 can be part of a hybrid control system (equipped with manual and robotic components) for achieving superior aortic access and neurovascular treatment site access. For example, in such a hybrid system, superior aortic access can be driven by robotic control, while neurovascular site access and embolization or other procedures can be performed manually. Alternatively, in such a hybrid system, superior aortic access can be performed manually, while neurovascular site access can be achieved by robotic control. Furthermore, in such a hybrid system, any one or more of the guidewire, access catheter, guide catheter, or treatment catheter can be driven by robotic control or operated manually.

[0168] An exemplary robot control system may include at least a guidewire hub (e.g., guidewire hub 2909) configured to adjust the axial and rotational positions of the guidewire 2907, respectively. The robot control system may also include an insertion access catheter hub 2910 configured to adjust the axial and rotational movement of the access catheter 2902. The robot control system may also include a guide catheter hub 2914 configured to control the axial movement of the guide catheter 2906. The robot control system may also include a treatment catheter hub 2912 configured to adjust the axial and rotational positions of the treatment catheter 2904.

[0169] In some embodiments, the treatment catheter hub 2912 is further configured to laterally deflect the distal deflection zone of the treatment catheter 2904.

[0170] In some embodiments, the guidewire hub 2909 is configured to connect to the guidewire hub adapter by magnetically connecting the guidewire hub to a first drive magnet. The insertion or access catheter hub 2910 is configured to connect to the access catheter hub adapter by magnetically connecting the insertion or access catheter hub 2910 to a second drive magnet. The treatment catheter hub 2912 is configured to connect to the treatment catheter hub adapter by magnetically connecting the treatment catheter hub 2912 to a 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 a fourth drive magnet. In some embodiments, the first, second, third, and fourth drive magnets are independently movable and supported by a drive table.

[0171] In some embodiments, the robot control system includes a first driven magnet on a guide wire hub 2909. The first driven magnet can be configured to cooperate with a first driving magnet, and the first driven magnet is configured to move in response to the movement of the first driving magnet. In some embodiments, the first driving magnet is configured to move outside a sterile field separated from the first driven magnet by a barrier, while the first driven magnet is within the sterile field. In some embodiments, the position of the first driven magnet is movable in response to operation of a procedure drive control unit on a control console associated with a drive table. The interaction between the driving magnet and the driven magnet is described in detail with respect to Figure 4 above.

[0172] In some embodiments, the robotic control system includes a second driven magnet on the insertion or access catheter hub 2910. The second driven magnet can be configured to cooperate with a second driving magnet, and the second driven magnet is configured to move in response to the movement of the second driving magnet. In some embodiments, the second driving magnet is configured to move outside a sterile field separated from the second driven magnet by a barrier, while the second driven magnet is within the sterile field.

[0173] In some embodiments, the robot control system includes a third driven magnet on the treatment catheter hub 2912. The third driven magnet can be configured to cooperate with a third driving magnet, and the third driven magnet is configured to move in response to the movement of the third driving magnet. In some embodiments, the third driving magnet is configured to move outside a sterile field separated from the third driven magnet by a barrier, while the third driven magnet is within the sterile field.

[0174] 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 a fourth driving magnet, and the fourth driven magnet is configured to move in response to the movement of the fourth driving magnet. In some embodiments, the fourth driving magnet is configured to move outside a sterile field separated from the fourth driven magnet by a barrier, while the fourth driven magnet is within the sterile field. In some embodiments, five or more driven magnets and corresponding catheter hubs may be present for additional catheter control.

[0175] In some embodiments, the devices described herein (e.g., hubs, hub adapters, intervention devices, and / or trays) can be used during robot-controlled procedures. For example, in a robot-controlled procedure, one or more of the intervention devices can be driven through the vascular system to the procedure site. Driving such devices by robot control can include engaging with electromechanical components controlled by user input. In some implementations, the user can provide input to a control system that interfaces with one or more hubs and hub adapters.

[0176] In some embodiments, the hubs, hub adapters, intervention devices, and trays described herein can be used during non-robot (e.g., manually driven) procedures. Manually driving such devices can include manually engaging the hubs to influence the movement of the intervention devices.

[0177] In some embodiments, the devices described herein can be used to carry out methods for performing intracranial procedures in an intracranial position. Methods for performing intracranial procedures can include any of the same steps as those described herein for performing neurovascular procedures. The procedures can be performed under robotic control, manually, or as a hybrid combination of both.

[0178] While the above describes the magnetic coupling of a hub to a drive magnet, in other embodiments, either the intervention device and / or the hub can be mechanically coupled to the drive system. Any of the methods described herein may include the step of mechanically coupling one or more intervention devices (e.g., guidewire hub 2907, access catheter 2902, treatment catheter 2904, and / or guide catheter 2906) and / or one or more hubs (e.g., guidewire hub 2909, insertion or access catheter hub 2910, treatment catheter hub 2912, and / or guide catheter hub 2914) with one or more drive mechanisms.

[0179] Figure 19 illustrates a mechanical coupling mechanism 1654 between the drive mechanism 1650 and the driven mechanism 1652. Unless otherwise described herein, the drive mechanism 1650 and the driven mechanism 1652 may have the same or similar features or functions as the drive magnet 67 and the driven magnet 69, respectively. The drive mechanism 1650 may be part of or coupled to a hub adapter (e.g., hub adapter 48). The driven mechanism 1652 may be part of or coupled to a hub (e.g., hub 36, guidewire hub 2909, insertion or access catheter hub 2910, treatment catheter hub 2912, or guide catheter hub 2914). In some cases, the mechanical coupling mechanism 1654 may include a structural support (e.g., a support rod or support strut) extending transversely through the seal in the sterile barrier 1632. The seal can allow the structural support to advance along the length of the sterile barrier 1632 while maintaining a seal with the structural support in order to maintain a sterile field when the drive mechanism 1650 and the driven mechanism 1652 are moved forward and / or backward, as described herein. For example, the seal can include a tongue and groove closing mechanism along the sterile barrier 1632, which is configured to close on either side of the structural support while allowing the structural support to pass through the sterile barrier 1632 and while maintaining a seal with the structural support as the structural support is advanced along the length of the sterile barrier 1632.

[0180] In some embodiments, the structural support can extend through an elongated self-closing seal between two adjacent joint edges of a flexible material extending along an axis (e.g., similar in shape to a duckbill valve). As the structural support advances along the axis between the joint edges, the joint edges can allow the structural support to advance and then be biased to retract to seal with each other as the structural support passes any given point along the axis.

[0181] In some embodiments, the drive mechanism can be a spline drive shaft (e.g., a non-sterile spline drive shaft). The mechanical coupling mechanism 1654 can include a pulley in a plate acting as a sterile barrier 1632 and a sterile spline shaft configured to be coupled to the driven mechanism 1652. The driven mechanism 1652 can be a sterile pulley that receives the sterile spline shaft from the sterile barrier. In some embodiments, one or more spline drive shafts can engage with corresponding pulleys in a plate acting as a sterile barrier and rotate them. Each hub can have a sterile pulley 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, and it can rotate the sterile pulley in the hub via the sterile spline shaft.

[0182] It will be understood by those skilled in the art that any embodiment described herein can be modified to incorporate a mechanical coupling mechanism, for example, as shown in Figure 19.

[0183] The intervention devices described herein may be provided individually, or at least some of the intervention devices may be provided in a pre-assembled (e.g., nested or stacked) configuration. For example, the intervention devices may be provided in the form of an intervention device assembly (e.g., intervention device assembly 2900) in a concentric nested or stacked configuration. If provided individually, each catheter (and, in some embodiments, each corresponding catheter hub) may be unpackaged and primed, and the air may be removed by flushing the catheter (and, in some embodiments, the corresponding catheter hub) to remove air from its inner lumen and replacing the air with a fluid (e.g., saline solution, contrast medium, or a mixture of saline solution and contrast medium). After priming, the intervention devices may be manually assembled into a stacked configuration so that they are ready to be introduced into the body for surgical procedures, for example, via an introducer sheath.

[0184] Assembling the devices into a stacked configuration can involve inserting the intervention devices individually into each other in order of size. For example, the intervention device with the second largest diameter can be inserted into the lumen of the intervention device with the largest diameter. Then, the intervention device with the third largest diameter can be inserted into the intervention device with the second largest diameter, and so on.

[0185] For example, with respect to Figure 17, assembly can be performed by first inserting the distal end of the treatment catheter 2904 into the guide catheter 2906 through the guide catheter hub 2914. The treatment catheter 2904 can be advanced through the guide catheter 2906 until its distal tip is coplanar with or extends beyond the distal tip of the guide catheter 2906, and / or until the treatment catheter 2904 can no longer be inserted. Next, the distal end of the catheter 2902 can be inserted into the treatment catheter 2904 through the treatment catheter hub 2912. The catheter 2902 can be advanced through the treatment catheter 2904 until its distal tip is coplanar with or extends beyond the distal tip of the treatment catheter 2904, and / or until the catheter 2902 can no longer be inserted. Next, the distal end of the guidewire 2907 can be inserted into the catheter 2902 through the insertion or access catheter hub 2910. The guidewire 2907 can be advanced through the catheter 2902 until its distal tip is coplanar with or extends beyond the distal tip of the catheter 2902, and / or until it can no longer be inserted further.

[0186] Embodiments in which two or more intervention devices are packaged together as a single unit in an assembled (e.g., nested or stacked) configuration can provide efficient unpackaging and preparation before use, as well as efficient assembly within a robotic control system. The intervention devices can be pre-mounted on their respective hubs before packaging. In certain embodiments, two, three, or more intervention devices can be packaged in a fully nested (i.e., fully axially inserted) or nearly nested configuration. In a fully nested configuration, each intervention device is inserted as far as possible into adjacent distal hubs and intervention devices. Such a fully nested configuration can minimize the total length of the intervention device assembly and minimize the size of the packaging required to house the intervention device assembly.

[0187] In some embodiments, the intervention device can also be sterilized while in the assembly configuration before packaging, for example, using ethylene oxide gas. In some embodiments, the intervention device can be packaged while in the assembly configuration before sterilization with ethylene oxide gas. With respect to intervention devices in nested or stacked configurations, ethylene oxide gas can be supplied for sterilization into the space between adjacent intervention devices (e.g., the annular lumen between the outer diameter of a first intervention device nested inside a second intervention device and the inner diameter of a second intervention device). In some embodiments, the intervention device assembly can be packaged in a thermoformed tray and sealed with an HDPE (e.g., Tyvek®) lid. The intervention device assembly can be unpackaged by a user in a non-sterile field removing the lid (e.g., opening or peeling it off). The user in a sterile field can then remove the intervention device assembly and place it on a sterile work surface, for example, a robot-driven table, as described herein.

[0188] Packaging the intervention devices in an assembled and sterile state can reduce the time associated with unpackaging and assembling individual intervention devices, and facilitate efficient connection to the robotic drive system. Each intervention device and hub combination can be further packaged with fluidic connections for connecting to a fluid supply source and / or vacuum supply source. In some embodiments, each hub or hemostatic valve connected to a hub can include a fluidic connection.

[0189] After the intervention device assembly has been unpackaged (for example, after the intervention device assembly has been positioned on a robot-driven table), priming can be performed while the devices are concentrically nested or stacked. This is preferably achieved in each fluid lumen, such as the annular lumen between the guide catheter 2906 and the treatment catheter 2904, and between each of the additional concentric intervention devices in the concentric stack. In certain embodiments, the fluid lumen may include a lumen between a distal hub and a proximal intervention device, such as the lumen between the guide catheter hub 2914 and the treatment catheter 2904. In certain embodiments, priming can be performed while the devices are still in sterile packaging. Fluidic connections can be connected to a fluidic system for delivering saline and contrast media to the catheter and for providing aspiration. In some embodiments, the fluidic connections can be routed outside the sterile field for connection to the fluidic system. Once connected, the fluid engineering system can perform a priming sequence to flush each catheter of the intervention device assembly with a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium). The priming sequence may also include flushing each corresponding catheter hub with the fluid. The fluid may be degassed or degassed by the fluid engineering system before priming. In some embodiments, a vacuum source of the fluid engineering system may also be used to remove air from each catheter during fluid flushing. In certain embodiments, the tip of the catheter may be placed in a container of fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) during priming, so that when a vacuum source is applied, the fluid (not air) in the container is drawn through the tip of the catheter.In other embodiments, the tip of the catheter can be sealed (e.g., using a plug) to prevent air from being drawn out of the tip of the catheter when a vacuum source is applied. In certain embodiments, the priming process can be automated so that a user can provide a single command and so that each catheter (and, in some embodiments, each corresponding catheter hub) can be primed sequentially (e.g., as described with respect to Figures 20A-20C) or simultaneously.

[0190] Further details relating to the fluid engineering system are disclosed in U.S. Patent Application No. 17 / 879,614, filed on 2 August 2022, entitled "Multi Catheter System With Integrated Fluidics Management," which is expressly incorporated herein by reference in its entirety.

[0191] When there is a reduction in lumen cross-sectional area for flow, for example, when a second intervention device (e.g., a catheter or guidewire) extends into the lumen of the first intervention device, the fluid resistance within the lumen can be greater. The amount of fluid resistance can be influenced by the length of the sectional constriction, for example, due to the depth of axial insertion of the second intervention device into the first intervention device. A second intervention device that partially extends through the lumen of the first intervention device will provide a smaller length of sectional constriction, and therefore may result in lower fluid resistance within the lumen of the first catheter than if the second intervention device fully extended through the lumen of the first intervention device. Thus, fluid resistance can be reduced by at least partially reducing the depth of axial insertion (i.e., axial overlap) of the second intervention device into the lumen through which fluid will be injected (e.g., the length of the second intervention device into its concentrically adjacent lumens).

[0192] In some embodiments, when the insertion depth of the second intervention device within the first intervention device exceeds a certain depth (e.g., when the second intervention device is at or near the maximum insertion depth within the first intervention device), the size of the fluid channel between the devices (e.g., the annular lumen between the first and second intervention devices) may lead to a fluid resistance higher than the desired amount of fluid resistance during the priming procedure. In some embodiments, the insertion depth of the second intervention device within the first intervention device can be reduced to lower the pressure required to prime the catheter and to reduce internal interference.

[0193] In some embodiments, a catheter within an intervention device assembly can be separated from other intervention devices for priming to reduce the pressure required to prime the catheter and to reduce internal interference. A primed catheter can be separated from intervention devices in the catheter lumen by retracting the intervention devices proximal to the catheter lumen. For example, an intervention device in the lumen of a primed catheter can be retracted as proximal as possible from the primed catheter while still maintaining a nested or stacked relationship (e.g., at least about 2 cm or 5 cm or more of axial overlap) to minimize the pressure required to prime the catheter and to minimize internal interference. In other words, a catheter can be separated from a more proximal intervention device for priming while the distal tip of an adjacent proximal intervention device remains positioned within the catheter lumen. Maintaining at least some of the distal tips of adjacent proximal intervention devices within the catheter lumen can allow for easier reinsertion and advancement of the proximal intervention device after priming.

[0194] In some embodiments, the axial overlap is between about 2 cm and about 20 cm, between about 2 cm and 10 cm, between about 2 cm and 5 cm, between about 5 cm and 20 cm, between about 5 cm and 10 cm, or can be in any other suitable range. In some embodiments, the axial overlap is at least about 2 cm, at least about 5 cm, at least about 10 cm, at least about 20 cm, 2 cm or less, 5 cm or less, 10 cm or less, 20 cm or less, about 2 cm, about 5 cm, about 10 cm, about 20 cm, or can be any other suitable amount.

[0195] In some embodiments, the robotic drive table can be programmed to retract the inner access device as proximally as possible from the primed catheter while still maintaining a nested or stacked relationship. In other embodiments, the robotic drive table can be programmed to separate the inner device from the primed catheter to a distance sufficient to optimize the length of the unobstructed lumen and to result in an amount of fluid resistance lower than a threshold value. After the primed catheter is separated from other access devices, the catheter can be primed by flushing the catheter with a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium, etc.).

[0196] After the catheter has been primed, it can be returned to its initial position, and the next catheter in the intervention device assembly can be separated from the other intervention devices in its lumen for priming. This sequence can be repeated for each catheter in the intervention device assembly. In other embodiments, after the catheter has been primed, it can be advanced to a ready or drive position for beginning insertion into the patient. While the foregoing describes separating the catheter to be primed by retracting the internal intervention device, the external catheter can also be separated from the internal intervention device by advancing the external catheter axially distal to the internal intervention device. Examples of the priming process are illustrated with reference to Figures 20A–20C.

[0197] FIG. 20A depicts an interventional device assembly 2900 assembled in a concentric stack configuration compressed axially. As shown in FIG. 20A, the interventional devices are capable of being fully nested within one another. This can be a configuration that follows packaging of the device assembly 2900 and placement onto a robotic drive table. The priming sequence can begin, for example, by axially advancing the guide catheter 2906 and guide catheter hub 2914 distally relative to the treatment catheter 2904, treatment catheter hub 2912, catheter 2902, insertion or access catheter hub 2910, guide wire 2907, and guide wire hub 2909 as far as possible while maintaining the distal tip of the treatment catheter 2904 within the lumen of the guide catheter 2906, as shown in FIG. 20B, or to a distance that will result in a desirable amount of fluid resistance for priming. In some embodiments, the guide catheter 2906 is advanced in response to a control signal from a control system. The guide 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. Priming the guide catheter 2906 can include priming the guide catheter hub 2914. For example, in certain embodiments, the guide catheter hub 2914 or a hemostatic valve connected thereto can include a fluidics connection for receiving the priming fluid from the fluidics system. After priming, the guide catheter 2906 can be returned to its initial position (e.g., a fully axially compressed configuration) as shown in FIG. 20A. In some embodiments, the guide catheter 2906 is returned to its initial position in response to a control signal from a control system.

[0198] After the guide catheter 2906 has been primed and returned to its initial position, the treatment catheter 2904 and the treatment catheter hub 2912 can be advanced distally axially relative to the catheter 2902, the insertion or access catheter hub 2910, the guidewire 2907, and the guidewire hub 2909, for example, as shown in Figure 20C, while maintaining the distal tip of the catheter 2902 within the lumen of the treatment catheter 2904, or to a distance that will result in a desired amount of fluid resistance for priming (and the guide catheter 2906 and the guide catheter hub 2914 can also be advanced distally axially without changing or minimally changing their relative positions to the treatment catheter 2904). In some embodiments, the treatment catheter 2904 and the guide catheter 2906 are advanced in response to control signals from a control system. The treatment catheter 2904 can then be primed by introducing a priming fluid using a fluid engineering system. In some embodiments, the priming fluid is introduced in response to a control signal from a control system. Priming the treatment catheter 2904 may include priming the treatment catheter hub 2912. For example, in certain embodiments, the treatment catheter hub 2912 or a hemostatic valve connected thereto may include a hydrodynamic connection for receiving the priming fluid from a fluid dynamics system. After priming, the treatment catheter 2904 and the guide catheter 2906 may be returned to their initial positions (e.g., a fully axially compressed configuration) as shown in Figure 20A. In some embodiments, the treatment catheter 2904 and the guide catheter 2906 are returned to their initial positions in response to a control signal from a control system.

[0199] After the treatment catheter 2904 has been primed and returned to its initial position, the catheter 2902 and the insertion or access catheter hub 2910 can be advanced distally axially relative to the guidewire 2907 and guidewire hub 2909, for example, as far as possible while maintaining the distal tip of the guidewire 2907 within the lumen of the catheter 2902, or to a distance that will result in a desired amount of fluid resistance for priming (and the guide catheter 2906, guide catheter hub 2914, treatment catheter 2904, and treatment catheter hub 2912 can also be advanced distally axially without changing or minimally changing their relative positions to the catheter 2902). In some embodiments, the catheter 2902, treatment catheter 2904, and guide catheter 2906 are advanced in response to control signals from a control system. The catheter 2902 can then be primed by introducing a priming fluid using a fluid engineering system. In some embodiments, the priming fluid is introduced in response to control signals from a control system. Priming catheter 2902 may include priming the insertion or access catheter hub 2910. For example, in certain embodiments, the insertion or access catheter hub 2910 or a hemostatic valve connected thereto may include a fluidic connection for receiving priming fluid from a fluidic system. After priming, catheters 2902 and 2904 and 2906 may be returned to their initial positions as shown in Figure 20A (e.g., a fully axially compressed configuration). In some embodiments, catheter 2902, treatment catheter 2904, and guide catheter 2906 are returned to their initial positions in response to control signals from a control system.

[0200] In some embodiments, the priming procedure described with respect to Figures 20A to 20C 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 specific control signals. In some embodiments, the priming of each specific intervention device can be performed in response to a specific control signal.

[0201] In an alternative embodiment, each catheter can be simultaneously separated distally from each other for priming. For example, catheter 2902 can be separated distally from guidewire 2907 while maintaining the distal tip of guidewire 2907 in the lumen of catheter 2902, treatment catheter 2904 can be separated distally from catheter 2902 while maintaining the distal tip of catheter 2902 in the lumen of treatment catheter 2904, and guide catheter 2906 can be separated distally from treatment catheter 2904 while maintaining the distal tip of treatment catheter 2904 in the lumen of guide catheter 2906. However, an embodiment in which only one set of adjacent hubs are separated at a time, as described with respect to Figures 20A-20C, can provide a smaller overall length of the assembly at any given time, which can enable use with a smaller robotic drive system. The separation of the outer catheter from the inner intervention device is described as advancing the catheter distally and axially relative to the inner intervention device; however, the separation may also include retracting the inner intervention device proximal to the outer catheter.

[0202] In an alternative embodiment, one or more of the catheters 2902, treatment catheter 2904, and guide catheter 2906 can be advanced to a ready or drive position after priming (for example, before priming the subsequent catheter) to begin insertion into the patient. In such an embodiment, the catheter can be advanced to the ready or drive position after priming without returning to its initial position.

[0203] As described above, in some embodiments, catheters 2902, 2904, and 2906 can be assembled into a concentric stack orientation illustrated in Figure 17 before flushing the catheters to remove air by replacing the air with a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium). This is preferably achieved in each fluid lumen, such as the annular lumen between the guide catheter 2906 and the treatment catheter 2904, and between each of the additional concentric intervention devices in the concentric stack. Infusion of a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure can replace substantially all of the air, but some small bubbles may remain and may adhere to the inner wall of the outer catheter (e.g., guide catheter 2906), the outer wall of the inner catheter (e.g., treatment catheter 2904), or both.

[0204] While the fluid is being introduced under pressure into the proximal end of the annular lumen (for example, into the hub of the outer catheter or a hemostatic valve connected thereto), the inner catheter can be moved relative to the outer catheter, breaking the retaining force between the microbubbles and the adjacent wall, allowing the bubbles to be carried downstream and exit through the distal opening of the lumen or removed by aspiration. The catheters can be moved axially, rotationally, or both relative to each other. In certain embodiments, the catheters can reciprocate axially, rotationally, or both relative to each other. In some embodiments, the catheters can be moved intermittently axially, rotationally, or both. In other embodiments, the catheters can be rotated continuously or in a constant direction.

[0205] In some implementations, the first catheter is moved axially and reciprocally with respect to an adjacent catheter or guidewire over a stroke length that is, for example, in the range of approximately 1 mm to approximately 250 mm, approximately 10 mm to approximately 250 mm, approximately 5 mm to approximately 125 mm, approximately 25 mm to approximately 125 mm, approximately 10 mm to approximately 50 mm, approximately 15 mm to approximately 30 mm, approximately 5 mm to approximately 30 mm, approximately 15 mm to approximately 25 mm, approximately 20 mm to approximately 40 mm, or any other suitable range. In some implementations, the first catheter is moved axially back and forth relative to an adjacent catheter or guidewire over stroke lengths such as, for example, at least 5 mm, at least 10 mm, at least 15 mm, at least 20 mm, at least 25 mm, at least 30 mm, at least 50 mm, 10 mm or less, 20 mm or less, 25 mm or less, 30 mm or less, 50 mm or less, 125 mm or less, 150 mm or less, approximately 5 mm, approximately 10 mm, approximately 15 mm, approximately 20 mm, approximately 25 mm, approximately 30 mm, approximately 50 mm, or any other suitable stroke length.

[0206] In some implementations, the first catheter is reciprocated axially with respect to an adjacent catheter or guidewire at reciprocating frequencies in the range of approximately 0.5 Hz to approximately 1 Hz, approximately 1 Hz to approximately 5 Hz, approximately 1 Hz to approximately 10 Hz, approximately 1 Hz to approximately 25 Hz, approximately 5 Hz to approximately 10 Hz, approximately 10 Hz to approximately 25 Hz, or any other suitable range of frequencies. In some implementations, the first catheter is reciprocated axially with respect to an adjacent catheter or guidewire at reciprocating frequencies of at least 0.5 Hz, at least 1 Hz, at least 2 Hz, at least 5 Hz, at least 10 Hz, at least 25 Hz, 0.5 Hz or less, 1 Hz or less, 2 Hz or less, 5 Hz or less, 10 Hz or less, 25 Hz or less, approximately 0.5 Hz, approximately 1 Hz, approximately 2 Hz, approximately 5 Hz, approximately 10 Hz, approximately 25 Hz, or any other suitable frequency.

[0207] In one implementation, the first catheter is reciprocated axially with respect to an adjacent catheter or guidewire over a stroke length ranging from approximately 0.5 inches to approximately 10 inches, or from approximately 1 inch to approximately 5 inches, at a reciprocating motion frequency of, for example, approximately 5 cycles per second or less or 2 cycles per second or less.

[0208] In several implementation configurations, the first catheter is, for example, in the range of approximately 5 to 180 degrees, approximately 5 to 360 degrees, approximately 15 to 180 degrees, approximately 15 to 150 degrees, approximately 15 to 120 degrees, approximately 15 to 90 degrees, approximately 15 to 60 degrees, approximately 15 to 30 degrees, approximately 30 to 180 degrees, approximately 30 to 150 degrees, approximately 30 to 120 degrees, approximately 30 to 90 degrees, approximately 30 to 60 degrees, and approximately 60 degrees. It is reciprocated in the rotational direction relative to the adjacent catheter or guidewire over a range of rotation angles per stroke, such as approximately 180 degrees, approximately 60 to approximately 150 degrees, approximately 60 to approximately 120 degrees, approximately 60 to approximately 90 degrees, approximately 90 to approximately 180 degrees, approximately 90 to approximately 150 degrees, approximately 90 to approximately 120 degrees, approximately 120 to approximately 180 degrees, approximately 120 to approximately 150 degrees, approximately 150 to approximately 180 degrees, or any other suitable range. In some implementations, the first catheter is reciprocated in a rotational direction relative to an adjacent catheter or guidewire over a rotational angle per stroke of, for example, at least 5 degrees, at least 15 degrees, at least 30 degrees, at least 60 degrees, at least 90 degrees, at least 120 degrees, at least 150 degrees, at least 180 degrees, at least 360 degrees, 5 degrees or less, 15 degrees or less, 30 degrees or less, 60 degrees or less, 90 degrees or less, 120 degrees or less, 150 degrees or less, 180 degrees or less, 360 degrees or less, approximately 5 degrees, approximately 15 degrees, approximately 30 degrees, approximately 60 degrees, approximately 90 degrees, approximately 120 degrees, approximately 150 degrees, approximately 180 degrees, approximately 360 degrees, or any other suitable angle.

[0209] In some implementations, the first catheter is reciprocated in a rotational direction relative to an adjacent catheter or guidewire at reciprocating frequencies in the range of approximately 0.5 Hz to approximately 1 Hz, approximately 1 Hz to approximately 5 Hz, approximately 1 Hz to approximately 10 Hz, approximately 1 Hz to approximately 25 Hz, approximately 5 Hz to approximately 10 Hz, approximately 10 Hz to approximately 25 Hz, or any other suitable frequency range. In some implementations, the first catheter is reciprocated in a rotational direction relative to an adjacent catheter or guidewire at reciprocating frequencies of at least 0.5 Hz, at least 1 Hz, at least 2 Hz, at least 5 Hz, at least 10 Hz, at least 25 Hz, 0.5 Hz or less, 1 Hz or less, 2 Hz or less, 5 Hz or less, 10 Hz or less, 25 Hz or less, approximately 0.5 Hz, approximately 1 Hz, approximately 2 Hz, approximately 5 Hz, approximately 10 Hz, approximately 25 Hz, or any other suitable frequency.

[0210] In some implementations, the first catheter is moved back and forth over an adjacent catheter or guidewire over a number of reciprocations between 1 and 200, between 1 and 100, between 1 and 50, between 1 and 25, between 1 and 15, between 1 and 10, between 1 and 5, between 5 and 25, between 5 and 15, between 5 and 10, or any other suitable range of reciprocations. In some implementations, the first catheter is moved back and forth over an adjacent catheter or guidewire over at least 1 reciprocation, at least 2 reciprocation, at least 5 reciprocation, at least 10 reciprocation, at least 15 reciprocation, at least 25 reciprocation, at least 50 reciprocation, 5 reciprocation or less, 10 reciprocation or less, 15 reciprocation or less, 25 reciprocation or less, 50 reciprocation or less, 100 reciprocation or less, 200 reciprocation or less, approximately 1 reciprocation, approximately 2 reciprocation, approximately 5 reciprocation, approximately 10 reciprocation, approximately 25 reciprocation, approximately 50 reciprocation, approximately 100 reciprocation, approximately 200 reciprocation, or any other suitable number. A single reciprocating motion can include movement from a first position to a second position (either axially or rotationally), followed by a return motion from the second position to the first position.

[0211] In some implementations, the first catheter is moved back and forth against an adjacent catheter or guidewire for a duration of time in the range of approximately 1 second to 60 seconds, approximately 1 second to 45 seconds, approximately 1 second to 30 seconds, approximately 1 second to 20 seconds, approximately 1 second to 15 seconds, approximately 1 second to 10 seconds, approximately 5 seconds to 45 seconds, approximately 5 seconds to 30 seconds, approximately 5 seconds to 20 seconds, approximately 5 seconds to 15 seconds, approximately 5 seconds to 10 seconds, approximately 10 seconds to 30 seconds, approximately 10 seconds to 20 seconds, or any other suitable range. In some implementations, the first catheter is moved back and forth against an adjacent catheter or guidewire for a period of time of at least 1 second, at least 5 seconds, at least 10 seconds, at least 15 seconds, at least 20 seconds, at least 30 seconds, at least 45 seconds, at least 60 seconds, 5 seconds or less, 10 seconds or less, 15 seconds or less, 20 seconds or less, 30 seconds or less, 45 seconds or less, 60 seconds or less, approximately 5 seconds, approximately 10 seconds, approximately 15 seconds, approximately 20 seconds, approximately 30 seconds, approximately 45 seconds, approximately 60 seconds, or any other suitable period of time.

[0212] The reciprocating motion of adjacent catheters to break microbubbles can be achieved manually by grasping the corresponding catheter hubs and by manually moving the catheters axially or rotationally relative to each other while delivering a pressurized fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium). Alternatively, in a system driven by robotic control, for example, the processor can be configured to robotically drive at least one of two adjacent catheter hubs (e.g., at least one of the guide catheter hub 2914 and the treatment catheter hub 2912) to achieve relative movement between adjacent catheters, thereby breaking and expelling microbubbles, for example, in response to user activation of flush control. For example, in certain embodiments, two adjacent intervention devices can be moved relative to each other in response to control signals from a control system. In certain embodiments, delivery of pressurized fluid can be performed in response to control signals from a control system.

[0213] The reciprocating motion of adjacent catheters can generate shear forces to eliminate air bubbles. For example, relative movement of the inner and outer surfaces of adjacent catheters can increase the fluid shear rate between adjacent catheters during priming compared to static surfaces. In some embodiments, the shear force can be increased by increasing the flow rate of the solution provided by the fluid engineering system (e.g., saline, contrast medium, or a mixture of saline and contrast medium). In certain embodiments, both the flow rate and the relative movement between adjacent catheters are controlled to eliminate air bubbles.

[0214] In some embodiments, after each catheter has been primed by a fluid engineering system, an ultrasonic bubble detector may be used to confirm that there are substantially no air bubbles in the catheter. For example, an ultrasonic tip (e.g., mounted in a hub adjacent to the catheter receiving lumen) is run along the length of the catheter to confirm that no air bubbles remain in the system.

[0215] An example of a priming process involving the reciprocating movement of adjacent catheters is described with respect to Figures 21A and 21B.

[0216] Figure 21A depicts an intervention device assembly 2900 assembled in a concentric stack configuration. As shown in Figure 21A, the intervention devices can be fully nested within each other. This configuration can be followed by unpackaging the device assembly 2900 and placing it on a robotic drive table. Alternatively, the individual intervention devices of the device assembly 2900 can be assembled into the device assembly 2900 on the drive table.

[0217] The priming sequence can begin by priming the guide catheter 2906. In some embodiments, the guide catheter 2906 can be primed by introducing a fluid (e.g., saline solution, contrast medium, or a mixture of saline solution and contrast medium) into the lumen of the guide catheter 2906 under pressure, while causing reciprocating movement of the guide catheter 2906 and / or the guide catheter hub 2914 axially, rotationally, or both, relative to the treatment catheter 2904. Priming the guide catheter 2906 can include priming the guide catheter hub 2914. For example, in certain embodiments, the guide catheter hub 2914 or a hemostatic valve connected thereto may include a hydrodynamic connection for receiving the priming fluid from a fluidic system. In certain embodiments, the guide catheter 2906 and / or the guide catheter hub 2914 can be axially agitated back and forth along the longitudinal axis of the guide catheter 2906 (represented by axis A5 in Figures 21A and 21B) (for example, between the position in Figure 21A and the position in Figure 21B). The axial and / or rotational reciprocating motion of the guide catheter 2906 and / or the guide catheter hub 2914 can be performed manually or by a robot-driven table. The reciprocating motion can be generated in response to a control signal from a control system. Introducing fluid under pressure can be performed in response to a control signal from a control system.

[0218] In some embodiments, priming of the guide catheter 2906 can be performed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) into the lumen of the guide catheter 2906 under pressure while generating an axial, rotational, or both axial and rotational reciprocating movement of the treatment catheter 2904 and / or the treatment catheter hub 2912 with respect to the guide catheter 2906. The axial and / or rotational reciprocating movement of the treatment catheter 2904 and / or the treatment catheter hub 2912 can be performed manually or by a robotic drive table. The reciprocating movement can be generated in response to a control signal from a control system. Introducing the fluid under pressure can be performed in response to a control signal from a control system.

[0219] In some embodiments, priming of the guide catheter 2906 can be performed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) into the lumen of the guide catheter 2906 under pressure while generating a reciprocating movement of both the guide catheter 2906 (and / or the guide catheter hub 2914) and the treatment catheter 2904 (and / or the treatment catheter hub 2912) axially, rotationally, or both axially and rotationally relative to each other. The reciprocating movement can be generated in response to a control signal from a control system. Introducing the fluid under pressure can be performed in response to a control signal from a control system.

[0220] In some embodiments, after priming of the guide catheter 2906, the guide catheter 2906 can be returned to its initial position as shown in FIG. 21A. In other embodiments, after priming the guide catheter 2906, the guide catheter 2906 can be advanced to a preparation position or a drive position for initiating insertion into a patient.

[0221] In some embodiments, the treatment catheter 2904 can be primed after the guide catheter 2906 has been primed. Priming the treatment catheter 2904 may include priming the treatment catheter hub 2912. For example, in certain embodiments, the treatment catheter hub 2912 or a hemostatic valve connected thereto may include a hydrodynamic connection for receiving priming fluid from a hydrodynamic system. In some embodiments, the treatment catheter 2904 can be primed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) into the lumen of the treatment catheter 2904 under pressure, while generating reciprocating motion of the treatment catheter 2904 and / or the treatment catheter hub 2912 axially, rotationally, or both relative to the catheter 2902. The reciprocating motion may be generated in response to a control signal from a control system. Introducing the fluid under pressure may be carried out in response to a control signal from a control system.

[0222] In some embodiments, priming of the treatment catheter 2904 can be performed by introducing a fluid (e.g., saline solution, contrast medium, or a mixture of saline solution and contrast medium) into the lumen of the treatment catheter 2904 under pressure, while generating reciprocating motion of the catheter 2902 and / or the insertion or access catheter hub 2910 in the axial direction, rotational direction, or both relative to the treatment catheter 2904. The axial and / or rotational reciprocating motion of the catheter 2902 and / or the insertion or access catheter hub 2910 can be performed manually or by a robot-driven table. 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.

[0223] In some embodiments, priming of the treatment catheter 2904 can be performed by introducing a fluid (e.g., saline solution, contrast medium, or a mixture of saline solution and contrast medium) into the lumen of the treatment catheter 2904 under pressure, while generating reciprocating motion of both the treatment catheter 2904 (and / or the treatment catheter hub 2912) and the catheter 2902 (and / or the insertion or access catheter hub 2910) axially, rotationally, or both relative to each other. The reciprocating motion can be generated in response to a control signal from a control system. Introducing the fluid under pressure can be performed in response to a control signal from a control system.

[0224] In some embodiments, after priming the treatment catheter 2904, it is possible to return the treatment catheter 2904 to its initial position, as shown in Figure 21A. In some embodiments, after priming the treatment catheter 2904, it is possible to advance the treatment catheter 2904 to a ready or drive position for beginning insertion into the patient.

[0225] In some embodiments, catheter 2902 may be primed after the treatment catheter 2904 has been primed. Priming catheter 2902 may include priming the insertion or access catheter hub 2910. For example, in certain embodiments, the insertion or access catheter hub 2910 or a hemostatic valve connected thereto may include a hydrodynamic connection for receiving priming fluid from a hydrodynamic system. In some embodiments, catheter 2902 may be primed by introducing fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) into the lumen of catheter 2902 under pressure, while generating reciprocating motion of catheter 2902 and / or insertion or access catheter hub 2910 axially, rotationally, or both relative to the guidewire 2907. The reciprocating motion may be generated in response to a control signal from a control system. Introducing fluid under pressure may be carried out in response to a control signal from a control system.

[0226] In some embodiments, priming of the catheter 2902 can be performed by introducing a fluid (e.g., saline solution, contrast medium, or a mixture of saline solution and contrast medium) into the lumen of the catheter 2902 under pressure, while generating reciprocating motion of the guidewire 2907 and / or guidewire hub 2909 in the axial direction, rotational direction, or both relative to the catheter 2902. The axial and / or rotational reciprocating motion of the guidewire 2907 and / or guidewire hub 2909 can be performed manually or by a robot-driven table. 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.

[0227] In some embodiments, priming of the catheter 2902 can be performed by introducing a fluid (e.g., saline solution, contrast medium, or a mixture of saline solution and contrast medium) into the lumen of the catheter 2902 under pressure, while generating reciprocating motion of both the catheter 2902 (and / or insertion or access catheter hub 2910) and the guidewire 2907 (and / or guidewire hub 2909) axially, rotationally, or both relative to each other. The reciprocating motion can be generated in response to a control signal from a control system. Introducing the fluid under pressure can be performed in response to a control signal from a control system.

[0228] In some embodiments, after priming the catheter 2902, it is possible to return the catheter 2902 to its initial position, as shown in Figure 21A. In other embodiments, after priming the catheter 2902, it is possible to advance the catheter 2902 to a ready or drive position for beginning insertion into the patient.

[0229] In some embodiments, the priming procedure described with respect to Figures 21A and 21B 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 specific control signals. In some embodiments, the priming of each specific intervention device can be performed in response to a specific control signal.

[0230] In the priming sequence described herein with respect to Figures 21A and 21B, the catheters are primed in the order starting with the guide catheter 2906, followed by the treatment catheter 2904, and then catheter 2902. However, it is intended that the catheters may be primed in any order. The catheters may be primed in series as described above with respect to Figures 21A and 21B. Alternatively, two or more of the catheters, or each of the catheters, may be primed in parallel.

[0231] In certain embodiments, priming a catheter can include reducing the depth of the axial insertion (i.e., axial overlap) of a second intervention device into the lumen of a first intervention device through which fluid will be injected (e.g., the length of the second intervention device into its concentrically adjacent lumen), as described with respect to Figures 20A-20C, and also, as discussed with respect to Figures 21A and 21B, generating relative reciprocating motion between the first and second intervention devices in the axial, rotational, or both directions during priming.

[0232] In some implementations, catheter priming may include vibrating at least a portion of the catheter and / or its associated hub, if any. The vibration may be induced, for example, by an electric motor incorporated into the catheter hub, or by a separate electric motor or vibration source placed against the catheter during priming. In some implementations, at least a portion of the support table on which the catheter and / or its associated hub rests may be vibrated during the priming of any one or more catheters to assist in the removal of air and / or air microbubbles. Such vibration may be performed by an electric motor.

[0233] (Examples) Additional embodiments are disclosed in further detail in the following embodiments, and are not intended to limit the scope of the claims.

[0234] Figure 22 is a diagram of a test system used to detect the removal of air bubbles between concentrically stacked catheters. The test system included an inner catheter 2108 positioned within the inner lumen of an outer catheter 2106 in a concentric stack. The outer catheter 2106 was connected to a swivel hemostatic valve 2104. The hemostatic valve 2104 was connected to a syringe 2102, so that fluid injected using the syringe would flow through the lumen between the inner catheter 2108 and the outer catheter 2106. In the test system, the inner catheter 2108 had a diameter of approximately 0.071 inches. The outer catheter 2106 had a diameter of approximately 0.088 inches. The outer catheter 2106 was transparent to allow visualization of bubbles in the lumen. The distal end of the outer catheter 2108 allowed a small volume of fluid to exit the outer catheter. Figure 23A is a photograph showing catheters 2106 and 2108 in a concentric stack before fluid injection. Figure 23D is an illustration thereof.

[0235] (Example 1) In the first embodiment, syringe 2102 was used to inject water at a constant pressure of approximately 150 psi through the hemostatic valve 2104 without moving catheter 2106 or catheter 2108. Figure 23B is a photograph showing catheters 2106 and 2108 following the injection of water. Figure 23E is an illustration thereof. As shown in Figure 23B, a bubble is present in the lumen between catheters 2106 and 2108.

[0236] (Example 2) In the second embodiment, syringe 2102 was used to inject water at a constant pressure of approximately 150 psi through hemostatic valve 2104. Immediately after injecting water, axial reciprocating motion of the inner catheter 2108 was performed for approximately 10 seconds. The reciprocating motion was performed at a frequency of approximately 1 Hz (or less) and a stroke length of approximately 20 mm (or more). Figure 23C is a photograph showing catheters 2106 and 2108 following the axial reciprocating motion. Figure 23F is an illustration thereof. As shown in Figure 23C, the lumen between catheters 2106 and 2108 was substantially bubble-free.

[0237] (Example 3) In the third embodiment, instead of the outer catheter 2106 and inner catheter 2108 described in Examples 1 and 2, an outer catheter having a diameter of approximately 0.071 inches and an inner catheter having a diameter of approximately 0.035 inches were used in the test system 2100. Syringe 2102 was used to inject water at a constant pressure of approximately 150 psi through a hemostatic valve 2104 connected to the outer catheter. Immediately after injecting water, axial reciprocating motion of the inner catheter was performed for approximately 10 seconds. The reciprocating motion was performed at a frequency of approximately 1 Hz (or less) and a stroke length of approximately 20 mm (or more). Following the axial reciprocating motion, the lumen between the outer catheter and the inner catheter was found to be substantially bubble-free by visual inspection.

[0238] control system Figure 24 illustrates a schematic diagram of an example of a control system 4000 that may be used to electronically control the systems and components described herein and / or to carry out the methods described herein. The control system 4000 can be configured to automatically adjust various motors, hub adapters, hubs, intervention devices, fluid engineering components (e.g., valves, pumps, etc.), and / or any other components described herein in response to commands entered by an operator such as a physician. In response to commands entered by an operator, the control system 4000 can automatically trigger a series of response events.

[0239] In certain embodiments, the control system 4000 may include one or more processors 4002. One or more processors 4002 may be configured, for example, to automatically adjust various system components described herein in response to commands entered by an operator, using one or more control units 4004 of the control system 4000. A single control unit 4004 is shown in Figure 24. However, any appropriate number of control units may be provided to correspond to various functions of the system described herein. For example, in certain embodiments, each intervention device may have its own intrinsic control unit 4004 or set of control units 4004 capable of controlling various functions of the intervention device (e.g., axial movement, rotational movement, fluid supply (e.g., saline, contrast agent, etc.), suction, etc.).

[0240] In certain embodiments, one or more control units 4004 can control a priming function for one or more intervention devices. For example, one or more control units 4004 can be operated to cause an intervention device to perform a priming procedure, as illustrated with reference to Figures 20A to 20C. For example, one or more control units 4004 can be operated to cause axial movement of one or more intervention devices relative to one or more other intervention devices (for example, by causing axial movement of the corresponding hub and / or hub adapter). One or more control units 4004 can be operated to cause the introduction of fluid into the lumen of an intervention device in order to prime the intervention device.

[0241] In certain embodiments, one or more control units 4004 can be operated to cause the intervention device to perform a priming procedure, as described, for example, with reference to Figures 21A to 21B. For example, one or more control units 4004 can be operated to cause one or more intervention devices to reciprocate (e.g., axial and / or rotational reciprocating) relative to one or more other intervention devices (e.g., by causing the corresponding hub and / or hub adapter to reciprocate). One or more control units 4004 can be operated to cause the introduction of fluid into the lumen of the intervention device to prime the intervention device (e.g., during the relative reciprocating motion).

[0242] The processor 4002 can receive signals from one or more control units 4004 and, in response, initiate corresponding actions in the components of the system described herein. For example, the processor 4002 can be configured to generate output signals that cause the components of the system described herein to perform a response action.

[0243] While the foregoing describes intervention devices driven by robotic control and manually driven intervention devices, the devices can be manually driven, robotic controlled, or any combination of manually driven and robotic controlled intervention devices, as will be apparent to those skilled in the art in light of the disclosure herein.

[0244] The foregoing represents one specific implementation of a robotic control system. As those skilled in the art will recognize in light of the disclosure herein, a wide variety of different robotic control system constructions can be fabricated to drive intervention devices by robotic control, to support two, three, four or more assemblies, and to move them forward and backward in the axial direction.

[0245] While the foregoing describes an intervention device driven by a drive table, other suitable robotic drive systems or mechanisms can be used to drive the intervention device, as those skilled in the art will recognize in light of the disclosure herein.

[0246] Various systems and methods are described herein primarily in the context of neurovascular access or procedures (e.g., nerve thrombectomy). However, the catheters, systems (e.g., drive systems), and methods disclosed herein can be readily adapted to any of the wide variety of other diagnostic and therapeutic applications throughout the body, including, among others, intravascular procedures 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 within the body.

[0247] Magnetic coupling for torque transmission In some embodiments, magnets (e.g., neodymium magnets) can be used to transmit torque through a sterile barrier. For example, one or more magnets outside a sterile field can be coupled to corresponding magnets inside the sterile field, so that the rotation of one or more magnets outside the sterile field can cause the corresponding rotation of one or more magnets inside the sterile field.

[0248] A torque transfer system can transmit torque from outside a sterile field (e.g., from a hub adapter) into a sterile field (e.g., to a hub). The torque transfer system may also be referred to as a magnetic coupling or a rotational magnetic coupling. In certain embodiments, the hub adapter may be reusable (e.g., part of capital equipment in an operating room), and the hub may be disposable. In some embodiments, the torque transfer system can facilitate the provision of torque for rotating an intervention device coupled to a hub without a motor and motor control board on a disposable hub, which can significantly reduce equipment and procedure costs. In addition, some embodiments of the torque transfer systems disclosed herein eliminate the need for cable management to each hub, increasing simplicity and reducing system costs. In some embodiments, the torque transfer system can facilitate the provision of torque for rotating other instruments in a robotic surgical system (e.g., a robotic surgical system for neurovascular procedures). For example, the torque transfer system can be used to actuate one or more valves, as described herein. Instruments used in robotic surgical procedures, or instruments used to prepare for robotic surgical procedures (including intervention devices), may be referred to as surgical instruments in this specification.

[0249] Figure 25 shows a partial embodiment of a robotic drive system 6000 having a hub 6001, a hub adapter 6005, and a torque transfer system 6002, which can be used with any embodiment of a robotic drive system disclosed herein and is capable of supporting and moving an instrument such as an intervention device (e.g., a catheter or guidewire), the instrument being connected to the hub 6001, and the instrument being configured to be inserted into the body during a medical procedure. In certain embodiments, the torque transfer system 6002 may include a drive-side torque transfer element and an instrument-side torque transfer element that is not in physical contact with the drive-side torque transfer unit. The torque transfer element may also be referred to as a torque transfer unit or torque transfer device. Figures 26–30 show additional details of the torque transfer system 6002. In some embodiments, increasing the width of the magnets can linearly increase the magnitude of the magnetic coupling force.

[0250] In certain embodiments, the torque transfer system 6002 may include a drive-side torque transfer element and an instrument-side torque transfer element, the instrument-side torque transfer element not connected to the drive-side torque transfer element by wires or other tangible or physical components. As described herein, the drive side of the robot drive system 6000 may be separated from the driven side by a sterile barrier. In some embodiments, the drive side of the robot drive system 6000 may be separated by a section of the drive table (e.g., a wall) and a sterile barrier positioned above the section of the drive table. The drive-side torque transfer element may be a non-sterile side torque transfer element. The driven side torque transfer element may be a sterile side torque transfer element.

[0251] While embodiments of torque transfer systems are not limited to those described herein, some embodiments of torque transfer systems disclosed herein may have a plurality of magnets configured to provide a magnetic coupling force or magnetic shear force between the drive-side torque transfer element and the fixture-side torque transfer element in order to transfer torque from the drive-side torque transfer element to the fixture-side torque transfer element.

[0252] In any embodiment disclosed herein, the robot drive system 6000 and / or any component of the robot drive system 6000 may have any component, feature, or other detail of any other embodiment of the robot drive system disclosed herein, and vice versa. The hub 6001 may have any component, feature, or other detail of any other hub disclosed herein, and vice versa. The hub adapter 6005 may have any component, feature, or other detail of any other hub adapter disclosed herein, and vice versa.

[0253] Some embodiments of the torque transfer system 6002 may include an active torque element 6004 (also referred to herein as the active torque transfer element) and a passive torque element 6006 (also referred to herein as the passive torque transfer element). The active torque element 6004 may be a drive-side torque transfer element or a non-sterile-side torque transfer element. The passive torque element 6006 may be a drive-side torque transfer element or a sterile-side torque element.

[0254] The active torque element 6004 can be positioned on the non-sterile side of a sterile barrier, and the passive torque element 6006 can be positioned on the sterile side of a sterile barrier. In some embodiments, the passive torque element 6006 can be configured to be rotationally coupled to a surgical instrument (e.g., any of the intervention devices described herein) so that the rotation of the passive torque element 6006 generally causes the rotation of the instrument coupled to the passive torque element 6006 (e.g., equal simultaneous rotations), or the rotation of at least the proximal portion of the instrument coupled to the passive torque element 6006 (e.g., unless the rotation of instrument I and the passive torque element 6006 is inhibited). In some embodiments, the passive torque element 6006 can be configured to be rotated by the rotation of the active torque element 6004 due to a magnetic coupling force between the active torque element 6004 and the passive torque element 6006, as will be described in more detail herein.

[0255] The passive torque element 6006 can be part of the hub 6001, supported by the hub 6001, or otherwise connected to the hub 6001. The active torque element can be part of the hub adapter 6005, supported by the hub adapter 6005, or otherwise connected to the hub adapter 6005. The sterile barrier can be positioned between the passive torque element 6006 and the active torque element 6004, such that the active torque element 6004 is positioned on the non-sterile side of the sterile barrier and the passive torque element 6006 is positioned on the sterile side of the sterile barrier. In certain embodiments, multiple torque transfer systems 6002 may exist, each connected to a separate hub 6001 or otherwise.

[0256] In certain embodiments, the motor 6030 can be coupled to the active torque element 6004 below the sterile barrier. The motor 6030 can cause the active torque element 6004 to rotate, and it can cause the passive torque element 6006 to rotate due to the magnetic coupling force between the active torque element 6004 and the passive torque element 6006.

[0257] In certain embodiments, the hub 6001 may include a support housing 6080. As described herein, the hub 6001 may be provided with rollers, which may be coupled to the support housing 6080. The hub adapter 6005 may include a support housing 6081. As described herein, the hub adapter 6005 may be provided with rollers, which may be coupled to the support housing 6081.

[0258] The hub 6001 can be configured to move axially, as described herein, to move the passive torque element 6006 and any intervention device connected thereto axially. The robotic drive system 6000 can be configured so that the passive torque element 6006 can be rotated to move (e.g., rotate) a surgical instrument (e.g., intervention device) connected to the hub 6001 without involving a puncture in the sterile barrier. In other words, this can be achieved without connecting the hub to any device or component on the non-sterile side of the sterile barrier, or without any electrical or communication wires, drive components, structural components, or other tangible components passing through the sterile barrier.

[0259] In certain embodiments, the intervention device connected to the hub 6001 may be a guidewire, guide catheter, treatment catheter, or access or insertion catheter. In certain embodiments, the treatment catheter may be a suction catheter, embolization deployment catheter, stent deployment catheter, flow diverter deployment catheter, diagnostic angiography catheter, stent retriever catheter, blood clot retriever, balloon catheter, catheter for facilitating percutaneous valve repair or replacement, ablation catheter, or any other suitable or desired device.

[0260] In some embodiments of the torque transfer system 6002, it is possible to use magnets (e.g., neodymium magnets, but not limited to) to transmit torque from an active torque element through a sterile barrier from the non-sterile side of the sterile barrier (e.g., the capital equipment side of the sterile barrier) to a hub 6001 located on the sterile side of the sterile barrier (e.g., the disposable side). In some embodiments, this makes it possible to eliminate penetration through the sterile barrier and also eliminate the need for motors and motor control boards on one or more disposable hubs, which can greatly increase patient safety and reduce the cost of treatment. In addition, the embodiments disclosed herein can eliminate or reduce the need for cable management to each hub, increasing the simplicity of the system.

[0261] In any embodiment of the torque transfer system 6002 disclosed herein, the magnets can be arranged in a circular or cylindrical arrangement (e.g., around a central axis). For example, the active torque transfer element 6004 can include a plurality of magnets arranged in a circular or cylindrical arrangement around a first central axis (e.g., central axis A6 shown in Figure 26). The passive torque transfer element 6006 can include a plurality of magnets arranged in a circular or cylindrical arrangement around a second central axis (e.g., central axis A7 shown in Figure 27). In some embodiments, the first central axis can be parallel to the second central axis. In some embodiments, the first central axis and / or the second central axis can be parallel to the central axis of an intervention device connected to the passive torque element.

[0262] A magnetic field can be generated between the active torque element 6004 and the passive torque element 6006. Such a device can be configured such that the rotation of the active torque element 6004, which is on the non-sterile side of the sterile barrier, acts a rotational force or torque on the passive torque element 6006 and the surgical instrument (e.g., intervention device) connected to it. This torque can rotate the passive torque element 6006 and the surgical instrument connected to it in response to the rotation of the active torque element 6004, provided that the passive torque element 6006 and / or the intervention device connected to the passive torque element 6006 are not prevented from rotating by an external force. In other words, in some embodiments, when the active torque element 6004 and the passive torque element 6006 are magnetically connected (for example, as long as any torque load on the passive torque element 6006 and / or (if present) the device connected to the passive torque element 6006 is not greater than the shear force generated by the magnetic field between the passive torque element 6006 and the active torque element 6004), the torque that can be exerted on the passive torque element 6006 by the active torque element 6004 is capable of rotating the passive torque element 6006 and any intervention device connected to it.

[0263] In some embodiments, the rotation of the passive torque element 6006 may be delayed in response to the rotation of the active torque element 6004, but after a short delay or lag time. This delay may, in some embodiments and not limited to, result from the elasticity of the shear force between the active torque element 6004 and the passive torque element 6006, and / or result from any force that inhibits the rotation of the passive torque element 6006, such as friction and / or inertial forces within the passive torque element 6006, friction and / or inertial forces or other torque-type forces acting on a surgical instrument (e.g., an intervention device) connected to the passive torque element 6006. In some embodiments, for the passive torque element 6006 and the instrument connected thereto to rotate, the shear or torque force provided by the magnetic field between the active torque element 6004 and the passive torque element 6006 must be greater than any force acting on the passive torque element 6006 and / or the surgical instrument that would impede rotation. Due to the arrangement of the active torque element 6004 relative to the passive torque element 6006, the passive torque element 6006 will, in some embodiments, rotate in the opposite direction to the direction in which the active torque element 6004 rotates, as well as the driven gear.

[0264] In any embodiment, as described, the sterile barrier can separate the active torque element 6004 from the passive torque element 6006. The magnetic field between the active torque element 6004 and the passive torque element 6006 can generate a torque that allows the passive torque element 6006 to rotate in response to the rotation of the active torque element 6004 without requiring any wiring or other connections to pass through the sterile barrier.

[0265] Referring to Figure 25, in some embodiments, the active torque element 6004 may have multiple magnetic elements 6010 having opposite poles, typically arranged in alternating positions, such that the first magnet 6016 of the magnetic element 6010 has a north pole (or positive pole) facing radially outward from the magnetic element 6010, and a second magnet 6018 adjacent to the first magnet 6016 has a south pole (or negative pole) facing radially outward. The next magnet in sequence may be another first magnet 6016 having a north pole facing radially outward from the magnetic element 6010, and so on in this alternating arrangement. In some embodiments, multiple first and second magnets 6016, 6018 may be supported between a first support 6012 and a second support 6014.

[0266] In some embodiments, the magnetic element 6010 may have eight or fewer (e.g., four, six, or eight) different poles or magnets 6016, 6018. In some embodiments, the magnetic element 6010 may have eight to twenty or more different poles or magnets 6016, 6018, ten to eighteen or more different poles or magnets 6016, 6018, or twelve to eighteen or more different poles or magnets 6016, 6018. In some embodiments, the magnetic element 6010 may have twelve to twenty different poles or magnets 6016, 6018, or twelve to twenty or more different poles or magnets 6016, 6018. In some embodiments, the magnetic element 6010 can have 12 or more (e.g., 12, 14, 16, 18, 20, 22, 24, or more) different poles or magnets 6016, 6018. In some embodiments, a higher number of poles can increase the resolution of rotational control of the instrument, providing the surgeon with a finer level of control for rotating or torqueing the instrument.

[0267] In any embodiment disclosed herein, the robot drive system 6000 may have two or more, three or more, or four or more torque transfer systems, each of which may have an active torque element 6004 and / or a passive torque element 6006.

[0268] In some embodiments, the first and second magnets 6016, 6018 can have an elongated rectangular parallelepiped shape. The magnet elements 6010 can have a space 6019 between each adjacent magnet. In some embodiments, each of the first and second magnets 6016, 6018 can have a wedge shape or an arc segment shape, so that each of the first and second magnets 6016, 6018 can fit together tightly and minimize or eliminate any gap between the first magnet 6016 and the second magnet 6018.

[0269] As shown in Figure 26, the first and second supports 6012, 6014 may have a plurality of grooves or recesses 6015 configured to receive and support the first and second magnets 6016, 6018. The first and second supports 6012, 6014 may be connected together, or may be monolithic, or may be fabricated from a single piece of material. As shown in some embodiments, the first and second supports 6012, 6014 may have a circular or disc-shaped form. The magnet element 6010 may be connected to a drive motor 6030 in the axial and rotational directions. The drive motor 6030 may be configured to rotate the magnet element 6010 in response to user input when the user wishes to rotate a catheter, guidewire, or any other desired intervention device (or other surgical instrument) connected to, for example, and not limited to, a passive torque element 6006. In certain embodiments, the magnet can be connected to a first and / or second support or other components of the magnetic element by screws, pins, adhesives, slots, grooves, and / or other mechanical fasteners.

[0270] Some embodiments of a magnet may have features configured to lock or secure to complementary features on a first and / or second support. For example, and not limited to, some embodiments of a magnet may have a T-shaped groove or other locking groove or channel in its radially inward-facing portion, which is configured to receive and / or engage with a complementary projection or feature on a radially outward-facing portion of the first and / or second support. Similarly, for example, and not limited to, some embodiments of a magnet may have a T-shaped projection on its radially inward-facing portion, which is configured to slide into and engage with a T-shaped slot on a radially outward-facing surface of the first and / or second support. In some embodiments, each magnet may have a slot (e.g., a T-shaped slot) on one side and a complementary projection (e.g., a T) on the opposite surface of the other side, and the magnets are configured to fit together during assembly, lock together with each other, and resist radial movement once assembled or in position.

[0271] As shown in Figure 26, some embodiments of the magnetic element 6010 may have an opening 6017 through which it passes. The opening 6017 may be configured to receive the shaft 6031 of the motor 6030 (as shown in Figure 25) through it. The opening 6017 may have a flat surface for indexing with the shaft 6031 or for preventing the shaft 6031 from rotating relative to the magnetic element 6010 in the assembled state.

[0272] In some embodiments, the magnetic element 6010 can be formed from a single magnet, which has multiple alternating poles, or multiple parts, each having either a north pole or a south pole, and arranged in an alternating configuration. For example, and not limited to, the magnetic element 6010 can be formed from a single magnet having 10 alternating poles or regions of alternating polarity (i.e., 5 north poles and 5 south poles in an alternating arrangement), or 12 or more alternating poles or regions of alternating polarity (i.e., 6 north poles and 6 south poles in an alternating arrangement), or 14 or more alternating poles or regions of alternating polarity (i.e., 7 north poles and 7 south poles in an alternating arrangement), or 16 or more alternating poles or regions of alternating polarity (i.e., 8 north poles and 8 south poles in an alternating arrangement), or 18 or more alternating poles or regions of alternating polarity (i.e., 9 north poles and 9 south poles in an alternating arrangement), or 20, 22, or 24 or more alternating poles.

[0273] Similarly, in some embodiments, referring to Figure 25, the passive torque element 6006 may have a magnet element 6050 which may have multiple north poles and south poles, typically arranged in an alternating manner, such that the first magnet 6056 of the magnet element 6050 has a north pole (or positive pole) facing radially outward from the magnet element 6050, and the second magnet 6058 adjacent to the first magnet 6056 has a south pole (or negative pole) facing radially outward. The next magnet in sequence may be another first magnet 6056 having a north pole facing radially outward from the magnet element 6050, and so on, in this alternating arrangement.

[0274] Any embodiment of the magnetic element 6050 can be configured similarly to any embodiment of the magnetic element 6010 described above, and for example, any embodiment of the magnetic element 6050 may have wedge-shaped or pie-shaped first and second magnets (for example, as described with respect to the first and second magnets 6116, 6118 of the magnetic element 6110 as shown in Figures 36 to 41). Any embodiment of the magnetic element 6050 may have any arrangement and number of magnets as described above with respect to the magnetic element 6010.

[0275] In some embodiments, the first and second magnets 6056, 6058 can have an elongated rectangular parallelepiped shape, as shown in Figures 29 and 30. The magnet elements 6050 can have a space or opening 6059 between each adjacent magnet. In some embodiments, each of the first and second magnets 6056, 6058 can have a wedge shape or an arc segment shape, so that each of the first and second magnets 6056, 6058 can fit together tightly, minimizing or eliminating any gap between the first magnet 6056 and the second magnet 6058.

[0276] In some embodiments, the magnetic element 6050 may have eight or fewer (e.g., four, six, or eight) different poles or magnets 6056, 6058. In some embodiments, the magnetic element 6050 may have eight to twelve different poles or magnets 6056, 6058, or eight to fourteen or more different poles or magnets 6056, 6058. In some embodiments, the magnetic element 6050 may have twelve to twenty different poles or magnets 6056, 6058, or twelve to twenty or more different poles or magnets 6056, 6058. In some embodiments, the magnetic element 6050 may have twelve or more (e.g., twelve, fourteen, sixteen, eighteen, or twenty or more) different poles (e.g., alternating poles) or magnets 6056, 6058.

[0277] In some embodiments, multiple first and second magnets 6056, 6058 can be supported between a first support 6052 and a second support 6054. The first and second supports 6052, 6054 can have multiple grooves or recesses 6055, which are configured to receive and support the first and second magnets 6056, 6058. The first and second supports 6052, 6054 can be connected together, or they can be monolithic or fabricated from a single piece of material. In some embodiments, as shown, the first and second supports 6052, 6054 can have a circular or disc-shaped form. The magnetic element 6050 can be connected axially and rotationally to an instrument connecting element 6070, and the instrument connecting element 6070 can be configured to receive an intervention device and to rotate the intervention device in response to the rotation of the magnetic element 6050.

[0278] As shown in Figure 26, some embodiments of the magnetic element 6050 may have a hub component 6057, which is configured to be at least partially received in an opening 6059 of the second support 6054 and an opening 6061 of the first support 6052. The opening 6059 allows axial passage through the second support 6054. The opening 6061 allows axial passage through the first support 6052. The hub component 6057 can be fixedly connected to the first and second supports 6052 and 6054. In some embodiments, the first support 6052, the second support 6054, and the hub component 6057 can be manufactured as separate individual pieces. In some embodiments, the first support 6052, the second support 6054, and the hub component 6057 can be fabricated together as a single monolithic piece, along with a plurality of grooves or recesses 6055 and openings 6059.

[0279] The device coupler 6063 may have a cylindrical body portion 6065, which can be received into an opening 6067 through which a hub component 6057 passes axially. In some embodiments, the hub component 6057 may include a tapered opening that can be configured to receive the cylindrical body portion 6065. In some embodiments, the cylindrical body portion 6065 may be coupled to the hub component 6057 and may be biased so as not to disengage from the hub component 6057 by friction or by an interference fit. In some embodiments, the cylindrical body portion 6065 may be a locking lure component used for a guide wire. In some embodiments, the hub component 6057 may include a shoulder portion on which a bearing can be mounted.

[0280] The opening 6071 is capable of extending axially through the instrument coupler 6063. The instrument coupler 6063 is configured to selectively tighten and contract around the outer surface of a surgical instrument (e.g., an intervention device (e.g., a guidewire or catheter)) extending through the instrument coupler 6063, thereby preventing the instrument from moving axially relative to the instrument coupler 6063.

[0281] In some embodiments, the magnetic element 6050 can be formed from a single magnet having multiple alternating poles or multiple parts, each having either a north pole or a south pole, and arranged in an alternating configuration. For example, and not limited to, the magnetic element 6050 can be formed from a single magnet having 10 alternating poles or regions of alternating polarity (i.e., 5 north poles and 5 south poles in an alternating configuration), or more than 10 alternating poles or regions of alternating polarity, or 12 alternating poles or regions of alternating polarity (i.e., 6 north poles and 6 south poles in an alternating configuration), or more than 12 alternating poles or regions of alternating polarity. In some embodiments, the magnetic element 6050 can be formed from a single magnet having 16 alternating pole or alternating polarity regions (i.e., 8 north poles and 8 south poles in an alternating arrangement), or more than 16 alternating pole or alternating polarity regions, or 18 alternating pole or alternating polarity regions (i.e., 9 north poles and 9 south poles in an alternating arrangement), or more than 18 alternating pole or alternating polarity regions.

[0282] In some embodiments, the magnetic element 6050 of the passive torque element 6006 can have a larger radius than the magnetic element 6010 of the active torque element 6004. This makes it possible to increase the torque applied to the intervention device connected to the passive torque element 6006 and to increase the rotational resolution of the intervention device connected to the passive torque element 6006.

[0283] The support housing 6080 (in which the passive torque element 6006 can be supported by or connected to the support housing 6080) can be configured to translate in any desired direction (for example, but not limited to, any axial direction parallel to the centerline axis of the intervention device connected to the passive torque element 6006 (represented by axis A8 in Figure 31)). The support housing 6080 can have one or more bearings, slides, wheels, or other features to facilitate movement of the support housing at least in the axial direction.

[0284] In some embodiments, as described herein, the hub adapter 6005 on the non-sterile side of the sterile barrier can be used to move the support housing (for example, and not limited to, using magnets, as in any other embodiments disclosed herein). Any such component can be combined in any combination with any of the components of the passive torque element 6006 to enable such axial movement of the support housing 6080.

[0285] In some embodiments, the magnets can be neodymium magnets. Any of the support components to which the magnets are connected can be made from any suitable or desired plastic, metal, or other material. In some embodiments, the first support 6012, the second support 6014, the first support 6052, and / or the second support 6054 can be molded plastic or metal, or 3D printed plastic or metal.

[0286] As described in some embodiments, the torque element can use alternating polarity neodymium magnets arranged in a circle. In some embodiments, the torque element (e.g., an active torque element or a passive torque element) can have 10 magnets arranged in a circle, or any number or desired number of magnets disclosed herein. The circle of any embodiment of the torque element disclosed herein can have an outer diameter of 1 inch, or approximately 1 inch, or from 0.5 inches to 2 inches, or any value, or from any value to any value disclosed within the aforementioned range. In some embodiments, the passive torque element can have 18 magnets arranged in a circle. The circle can have an outer diameter of 1.48 inches, or approximately 1.5 inches, or from 0.75 inches to 2.5 inches, or any value, or from any value to any value disclosed within the aforementioned range. In some embodiments, the passive torque element has a larger outer diameter than the active torque element, which can generate gear reduction, and gear reduction can increase the torque acting on the instrument compared to a smaller passive torque element. Furthermore, the larger diameter of the passive torque element may result in the magnetic element of the passive torque element being in very close proximity to the sterile barrier in some embodiments.

[0287] In some embodiments, the distance between the active torque element and the passive torque element can be 0 inches to 0.35 inches, approximately 0.35 inches, or greater than 0.35 inches. The strength of the magnetic field between the active and passive torque elements will decrease as the space between them increases. The strength of the magnetic field decreases proportionally to the square of the distance, and therefore the transmitted torque will decrease exponentially after a certain distance. In some embodiments, with a barrier thickness of 0.185 inches, the torque transfer system 6002 is capable of transmitting a peak torque of 46 mNm or approximately 46 mNm. In some embodiments, the guidewire and insertion catheter will be subjected to a torque force that can range from 10 mNm to 20 mNm. Therefore, in some embodiments, the torque transfer system 6002 can be configured to transmit torque from 0 mNm to 25 mNm or approximately 25 mNm, or from 0 mNm to 20 mNm or approximately 20 mNm, or to transmit peak torque of 20 mNm or approximately 20 mNm, or 25 mNm or approximately 25 mNm, or 30 mNm or approximately 30 mNm.

[0288] Figure 31 is a perspective view of an embodiment of the passive torque element 6106 connected to an intervention device I, where the intervention device I can be any of the intervention devices described herein. In any embodiment disclosed herein, the passive torque element 6106 can have any of the components, features, or other details of any other passive torque element embodiment disclosed herein, including, but not limited to, any embodiment of the passive torque element 6006 disclosed herein. Additionally, any embodiment of the passive torque element 6106 can be configured to accept and connect to any desired intervention device I.

[0289] For example, and not limited to, the passive torque element 6106 may have multiple magnetic elements 6150 having opposite poles, typically arranged in an alternating pattern, such that the first magnet 6156 of the magnetic element 6150 has a north pole (or positive pole) facing radially outward from the magnetic element 6150, and the second magnet 6158 adjacent to the first magnet 6156 has a south pole (or negative pole) facing radially outward. The next magnet in sequence may be another first magnet 6156 having a north pole facing radially outward from the magnetic element 6150, and so on in this alternating arrangement.

[0290] In some embodiments, the first and second magnets 6156, 6158 can have an elongated rectangular parallelepiped shape, as shown in Figure 33. The magnet elements 6150 can have a space 6159 between each adjacent magnet. In some embodiments, each of the first and second magnets 6156, 6158 can have a wedge shape or an arc segment shape, so that each of the first and second magnets 6156, 6158 can fit together tightly and minimize or eliminate all or excessive spacing between the first magnet 6156 and the second magnet 6158.

[0291] In some embodiments, the magnetic element 6150 may have eight or fewer (e.g., four, six, or eight) different poles or magnets 6156, 6158. In some embodiments, the magnetic element 6150 may have eight to twelve different poles or magnets 6156, 6158, or eight to fourteen or more different poles or magnets 6156, 6158. In some embodiments, the magnetic element 6150 may have twelve to twenty different poles or magnets 6156, 6158, or twelve to twenty or more different poles or magnets 6156, 6158. In some embodiments, the magnetic element 6150 may have twelve or more (e.g., twelve, fourteen, sixteen, eighteen, or twenty or more) different poles or magnets 6156, 6158.

[0292] The instrument coupler 6163 may have a cylindrical body portion 6165, which can be received into an opening through which the hub component 6157 passes axially. The opening may extend axially through the instrument coupler 6163. The instrument coupler 6163 may be configured to selectively tighten and contract around the outer surface of an intervention device (e.g., a guidewire or catheter) extending through the instrument coupler 6163, thereby preventing the instrument from moving axially relative to the instrument coupler 6163.

[0293] As shown in Figure 31, the instrument coupler 6163 and / or the magnetic element 6150 can be connected to a hemostatic valve such as a rotary hemostatic valve (RHV) 6160. The RHV 6160 may include a fluid port 6162, which can be installed in fluid communication with a fluid engineering system for the delivery of fluid (e.g., saline and / or contrast medium) to the instrument I and / or for the suction of fluid from the instrument I. The RHV 6160 may include a handle or lever 6164, which can be manually operated to control the RHV 6160. In other embodiments, the RHV 6160 can be operated by robotic control.

[0294] The RHV6160 can be configured to accept more proximal intervention devices through it. The RHV6160 is operable between various states, allowing and / or restricting the movement of intervention devices through it, and allowing and / or preventing fluid flow through it. For example, the RHV6160 may be operable between a first fully open state, a second partially open state (low sealing force state) that seals around intervention devices but allows sliding movement of the intervention devices, a third state that seals around intervention devices for high-pressure management, and a fourth fully closed state where no intervention devices extend through it.

[0295] In some embodiments, multiple first and second magnets 6156, 6158 can be supported between a first support 6152 and a second support 6154. The first and second supports 6152, 6154 can have multiple grooves or recesses 6155, which are configured to receive and support the first and second magnets 6156, 6158. The first and second supports 6152, 6154 can be connected together, or they can be monolithic or fabricated from a single piece of material. In some embodiments, as shown, the first and second supports 6152, 6154 can have a circular or disc-shaped form. The magnetic element 6150 can be connected to the instrument connecting element 6170 in the axial and rotational directions, and the instrument connecting element 6170 can be configured to receive a surgical instrument I (e.g., an intervention device) and to rotate the surgical instrument I in response to the rotation of the magnetic element 6150.

[0296] Figures 34-35 show alternative embodiments of the robot drive system 6000a, where both the active torque element 6004 and the passive torque element 6006 are positioned on the sterile side (e.g., the disposable side). As shown, in certain embodiments, the active torque element 6004 can be coupled to the hub 6001. For example, the active torque element 6004 and / or the motor 6030 can be mounted above the passive torque element 6006.

[0297] Figures 36 to 41 show another exemplary embodiment of the magnetic element 6110, which has a plurality of first and second magnets 6116, 6118 having opposite outward-facing poles, and the magnetic elements 6110 are arranged in an alternating manner, such that the first magnet 6116 of the magnetic element 6110 has a north pole (or positive pole) facing radially outward from the magnetic element 6110, and the second magnet 6118 adjacent to the first magnet 6116 has a south pole (or negative pole) facing radially outward. In some embodiments, the next magnet in sequence may be another first magnet 6116 having a north pole facing radially outward from the magnetic element 6110, and so on in this alternating arrangement. In some embodiments, the plurality of first and second magnets 6116, 6118 may be supported by a first support 6112. In some embodiments, the cross-sectional shapes of the first and second magnets 6116, 6118 can be pie-shaped or have a pie-shaped top. Any embodiment of the magnet element 6110 can be used in conjunction with any embodiment of the robot drive system 6000 disclosed herein.

[0298] In some embodiments, fasteners 6119, such as screws, can be used to connect the first and second magnets 6116 and 6118, respectively, to the first support 6112. The fasteners 6119 can advance through openings 6122 that extend longitudinally through the first and second magnets 6116 and 6118, respectively, and through openings 6124 in the first support 6112. In some embodiments, the openings 6124 can be threaded. In some embodiments, a recessed opening 6123 can be formed coaxially with the opening 6122, so that the head of the fastener 6119 can be recessed into the first and second magnets 6116 and 6118, respectively. In some embodiments, recessed openings, such as recess 6126, can be formed coaxially with each opening 6124, so that threaded nuts can be positioned and recessed within the first support 6112 for each fastener 6119. In some embodiments, the first support 6112 can have a central portion 6130 that extends axially away from the flange portion 6132. The central portion 6130 can provide a support surface for the radially inward-facing surfaces of the respective first and second magnets. The central portion 6130 can be coaxial with an opening 6140 that extends through the magnet element 6110.

[0299] As shown in Figure 41, in some embodiments, the arc-segment shaped magnets 6116, 6118 can have an overall length L1 of 0.375 in or approximately 0.375 inches. As shown in Figure 39, the arc-shaped segments can have sidewalls separated by an angle A of 29 degrees or approximately 29 degrees. The inner radius R1 of the arc-segment shaped magnets 6116, 6118 can be 0.250 in or approximately 0.250 in, and the outer radius R2 of the arc-segment shaped magnets 6116, 6118 can be 0.50 in or approximately 0.50 in. The diameter D1 of the opening 6122 extending through the arc-segment shaped magnets 6116, 6118 can be 0.079 in or approximately 0.079 in. The recess 6126 may have a diameter D2 of 0.134 in or approximately 0.134 in. The recess 6126 may have a length of 0.063 in or approximately 0.063 in. In other embodiments, any of the aforementioned values ​​may be increased or decreased by 10%, 20%, or 30%.

[0300] Figures 42A–43P illustrate additional embodiments of a torque transfer system in the form of a magnetic coupling, having magnets (e.g., neodymium magnets) for transmitting torque through a sterile barrier from capital equipment (e.g., hub adapter) to the disposable side of a surgical robot (e.g., to the hub, also referred to herein as the pack). As previously described, this can have the advantage of eliminating the need for motors and motor control boards on the disposable hub, significantly reducing the cost of equipment and procedures. In addition, some embodiments of the magnetic couplers disclosed herein eliminate the need for cable management to each hub, increasing simplicity and reducing the cost of the system.

[0301] Figures 42A–43P show a butted shaft configuration (face magnets) instead of the parallel shaft configuration (edge ​​magnets) shown in Figures 25–41. Magnetic torque coupling transmits rotary power without mechanical attachments. The absence of mechanical attachments such as drive shafts allows torque to be transmitted across a sterile barrier without the need to move components. While magnetic coupling significantly simplifies the workflow, it increases design complexity, and torque transmission is not fully understood. Demonstration tests will be used to quantify the effects of magnetic torque and the following factors.

[0302] Figures 42A and 42B show embodiments of a torque transfer system 6500 that may be configured to transfer torque force through a sterile barrier (designated by S in Figure 42A). In some embodiments, the torque transfer system 6500 may include an active torque element 6502 configured to be positioned on the non-sterile side (e.g., capital equipment side) of the sterile barrier, and a passive torque element 6504 configured to be positioned on the sterile side (e.g., disposable equipment side) of the sterile barrier.

[0303] In some embodiments, the active torque element 6502 may include a plurality of magnets arranged around a central axis (represented by axis A9 in Figure 42B). The plurality of magnets may include one or more first magnets 6514 and one or more second magnets 6516. The one or more first magnets 6514 may include a north pole or a positive pole facing axially toward the passive torque element 6504. The one or more second magnets 6516 may include a south pole or a negative pole facing axially toward the passive torque element 6504. The magnets 6514 and 6516 may be disk magnets. In some embodiments, the plurality of magnets of the active torque element 6502 may be arranged in a planar configuration on a plane parallel or generally parallel to the sterile barrier.

[0304] The passive torque element 6504 may include a plurality of magnets arranged around a central axis (e.g., axis A9). The plurality of magnets may include one or more first magnets 6554 and one or more second magnets 6556. The one or more first magnets 6554 may include a south pole or negative pole facing axially toward the active torque element 6502. The one or more second magnets 6556 may include a north pole or positive pole facing axially toward the active torque element 6502. The magnets 6554 and 6556 may be disk magnets. In some embodiments, the plurality of magnets of the passive torque element 6504 may be arranged in a planar configuration on a plane parallel or generally parallel to the sterile barrier.

[0305] The first magnet 6514 of the active torque element 6502 can be magnetically connected to the first magnet 6554 of the passive torque element 6504, and the second magnet 6516 of the active torque element 6502 can be connected to the second magnet 6556 of the passive torque element 6504. The rotation of the multiple magnets of the active torque element 6502 around the central axis of the multiple magnets of the active torque element 6502 can cause a corresponding rotation of the multiple magnets of the passive torque element 6504 around the central axis of the multiple magnets of the passive torque element 6504.

[0306] In some embodiments, the central axes of the multiple magnets of the active torque element 6502 can be coaxial with or parallel to the central axes of the multiple magnets of the passive torque element 6504. In some embodiments, the central axes of the multiple magnets of the active torque element 6502, and / or the central axes of the multiple magnets of the passive torque element 6504 can be transverse (e.g., perpendicular) to the direction of axial movement of the hub adapter, hub, and / or intervention device to which the components of the torque transfer system 6500 are connected.

[0307] In some embodiments, the active torque element may include a shaft 6512 configured to rotate around its longitudinal centerline axis (represented by A10 in Figure 42B). The longitudinal centerline axis of the shaft 6512 may be coaxial with the centerlines of the multiple magnets of the active torque element 6502 (e.g., axis A9). One or more first magnets 6514 and one or more second magnets 6516 may be coupled to the shaft 6512. In some embodiments, the active torque element 6502 may include a magnet support element 6540 positioned at the distal end of the shaft 6512 of the active torque element 6502 (e.g., coupled to or integrally formed with the distal end).

[0308] In some embodiments, the passive torque element 6504 may include a shaft 6522 configured to rotate around the longitudinal centerline axis of the shaft 6522. The longitudinal centerline axis of the shaft 6522 may be coaxial with the centerlines of the multiple magnets of the passive torque element 6504. One or more first magnets 6554 and one or more second magnets 6556 may be coupled to the shaft 6522. In some embodiments, the passive torque element 6504 may include a magnet support element 6550 positioned at the distal end of the shaft 6522 of the passive torque element 6504 (for example, coupled to or integrally formed with the distal end).

[0309] In some embodiments, the shaft 6512 of the active torque element 6502 can be rotated (e.g., by a motor) to cause the rotation of the magnet support element 6540 and / or multiple magnets of the active torque element 6502. The rotation of the multiple magnets of the active torque element 6502 can cause the rotation of the multiple magnets of the passive torque element 6504. The rotation of the multiple magnets and / or magnet support element 6550 of the passive torque element 6504 can cause the rotation of the shaft 6522.

[0310] The multiple magnets of the passive torque element 6504, the magnet support element 6550, and / or the shaft 6522 can be connected (e.g., directly or indirectly) to surgical instruments (e.g., intervention devices, valves, etc.) so that the rotation of the multiple magnets of the passive torque element 6504 can cause the corresponding movement of the surgical instrument (e.g., rotation of an intervention device, opening and / or closing of a valve, etc.).

[0311] Referring to Figures 43A to 43P, also disclosed herein are embodiments of a torque transfer system 7000 that can be configured to transfer torque force through a sterile barrier (designated by S in some figures). In some embodiments, the torque transfer system 7000 may include an active torque element 7002 configured to be positioned on the non-sterile side (e.g., capital equipment side) of the sterile barrier and a passive torque element 7004 configured to be positioned on the sterile side (e.g., disposable equipment side) of the sterile barrier S.

[0312] In some embodiments, the active torque element 7002 may include a shaft 7012 and at least a first magnet 7014, the shaft 7012 being configured to rotate about its longitudinal centerline axis (represented by A11 in Figure 43E), and at least the first magnet 7014 being directly or indirectly connected to the shaft 7012 of the active torque element 7002. In some embodiments, the passive torque element 7004 may include a shaft 7022 being configured to rotate about its longitudinal centerline axis, and the passive torque element 7004 may include at least a first magnet 7024 being directly or indirectly connected to the shaft 7022 of the passive torque element 7004.

[0313] The torque transfer system 7000 can be configured such that the first magnet 7024 of the passive torque element 7004 can be magnetically connected to the first magnet 7014 of the active torque element 7002. The torque transfer system 7000 can be configured such that when the first magnet 7024 of the passive torque element 7004 is magnetically connected to the first magnet 7014 of the active torque element 7002, the rotation of the shaft 7012 of the active torque element 7002 around the axis of the shaft 7012 of the active torque element 7002 acts as a torque on the shaft 7022 of the passive torque element 7004, and the torque biases the passive torque element 7004 to rotate around the axis of the shaft 7022 of the passive torque element 7004 (represented by A12 in Figure 43A). For example, rotation of shaft 7012 can cause movement of the first magnet 7014 of the active torque element 7002 (for example, around the axis of shaft 7012, or around the central axis of the multiple magnets of the active torque element 7002). Movement of the first magnet 7014 can cause movement of the first magnet 7024 of the passive torque element 7004 (for example, around the axis of shaft 7022, or around the central axis of the multiple magnets of the passive torque element 7004). Movement of the first magnet 7024 can cause rotation of shaft 7022 around the axis of shaft 7022.

[0314] The first magnet 7024 of the passive torque element 7004 can have the opposite polarity to the first magnet 7014 of the active torque element 7002, so that the first magnet 7024 of the passive torque element 7004 is attracted to the first magnet 7014 of the active torque element 7002. In some embodiments, the active torque element 7002 may further include a second magnet 7016, which is positioned at a distance from the first magnet 7014 of the active torque element 7002 and also at a distance from the centerline axis of the shaft 7012 of the active torque element 7002. The passive torque element 7004 may further include a second magnet 7026, which is positioned at a distance from the first magnet 7024 of the passive torque element 7004 and also at a distance from the centerline axis of the shaft 7022 of the passive torque element 7004. The torque transfer system 7000 may be configured such that the second magnet 7026 of the passive torque element 7004 is magnetically connectable to the second magnet 7016 of the active torque element 7002. The second magnet 7016 of the active torque element 7002 can have the opposite polarity to the first magnet 7014 of the active torque element 7002, and the second magnet 7026 of the passive torque element 7004 can have the opposite polarity to the first magnet 7024 of the passive torque element 7004, so that the second magnet 7016 of the active torque element 7002 is attracted to the second magnet 7026 of the passive torque element 7004.

[0315] In any embodiment disclosed herein, the active torque element 7002 may include a plurality of magnets (e.g., and not limited to, three or more magnets) arranged radially apart from each other and radially away from the centerline axis of the shaft 7012 of the active torque element 7002. The magnets of the active torque element 7002 may be cylindrical or disc-shaped, with a first polarity on the upper side of the disc and the opposite polarity on the bottom side of the disc. Similarly, the passive torque element 7004 may include a plurality of magnets arranged radially apart from each other and radially away from the centerline axis of the shaft 7022 of the passive torque element 7004. The magnets of the passive torque element 7004 may be cylindrical or disc-shaped, with a first polarity on the upper side of the disc and the opposite polarity on the bottom side of the disc. Each of the multiple magnets in the active torque element 7002 is configured to be alignable and magnetically connectable with each of the multiple magnets in the passive torque element 7004.

[0316] In some embodiments, the active torque element 7002 may further include a second magnet 7016 and a third magnet, all of which are spaced apart from each other, spaced apart from the first magnet 7014 of the active torque element 7002, and spaced apart from the centerline axis of the shaft 7012 of the active torque element 7002. Similarly, the passive torque element 7004 may further include a second magnet 7026 and a third magnet, all of which are spaced apart from each other, spaced apart from the first magnet 7024 of the passive torque element 7004, and spaced apart from the centerline axis of the shaft 7022 of the passive torque element 7004. The torque transfer system 7000 may be configured such that the second magnet 7026 of the passive torque element 7004 can be matched and / or magnetically coupled to the second magnet 7016 of the active torque element 7002, and the third magnet of the passive torque element 7004 can be matched and / or magnetically coupled to the third magnet of the active torque element 7002.

[0317] In some embodiments, the active torque element 7002 may further include a fourth magnet, the fourth magnet being spaced apart from the first magnet 7014, second magnet 7016, and third magnet of the active torque element 7002, and spaced apart from the centerline axis of the shaft 7012 of the active torque element 7002. The passive torque element 7004 may further include a fourth magnet, the fourth magnet being spaced apart from the first magnet 7024, second magnet 7026, and third magnet of the passive torque element 7004, and spaced apart from the centerline axis of the shaft 7022 of the passive torque element 7004. The torque transfer system 7000 may be configured such that the fourth magnet of the passive torque element 7004 is magnetically connectable to the fourth magnet of the active torque element 7002. An embodiment of a torque transfer system having an active torque element with four magnets and a passive torque element with four magnets is shown in Figures 42A to 42B.

[0318] In any embodiment disclosed herein, the active torque element 7002 may include a magnet support element 7040 positioned at the distal end of the shaft 7012 of the active torque element 7002 (e.g., connected to or integrally formed with the distal end). The magnet support element 7040 of the active torque element 7002 may be configured to support a plurality of magnets in a radially planar arrangement around the central axis of the plurality of magnets (which may be coaxial with the central axis of the shaft 7012 of the active torque element 7002). Similarly, the passive torque element 7004 may include a magnet support element 7050 positioned at the distal end of the shaft 7022 of the passive torque element 7004 (e.g., connected to or integrally formed with the distal end). The magnet support element 7050 of the torque element 7004 can be configured to support a plurality of magnets in a radially planar arrangement around the central axis of the plurality of magnets (which can be coaxial with the central axis of the shaft 7022 of the passive torque element 7004). In some embodiments, each of the plurality of magnets of the active torque element 7002 is configured to be alignable and magnetically connectable with each of the plurality of magnets of the passive torque element 7004.

[0319] In some embodiments, the magnet support element 7040 of the active torque element 7002 may include a disc-shaped body portion 7042 and a plurality of recesses 7044 formed within the disc-shaped body portion 7042, each of which may be configured to receive each of the magnets of the active torque element 7002. The disc-shaped body portion 7042 of the magnet support element 7040 of the active torque element 7002 may have a longitudinal centerline axis that coincides with the centerline axis of the shaft 7012 of the active torque element 7002.

[0320] As shown in Figure 43E, in certain embodiments, the magnet support element 7040 of the active torque element 7002 may include a disc-shaped body 7042, which may include a first recess 7044a formed within the disc-shaped body, configured to receive a first magnet 7014 of the active torque element 7002, and a second recess 7044b formed within the disc-shaped body 7042, configured to receive a second magnet 7016 of the active torque element 7002. The disc-shaped body 7042 of the magnet support element 7040 of the active torque element 7002 may have a longitudinal centerline axis that coincides with the centerline axis of the shaft 7012 of the active torque element 7002, so that the disc-shaped body 7042 of the magnet support element 7040 of the active torque element 7002 is coaxially aligned with the shaft 7012 of the active torque element 7002.

[0321] Similarly, the magnet support element 7050 of the passive torque element 7004 may have a disc-shaped body portion 7052 and a plurality of recesses 7054 formed within the disc-shaped body portion 7052, each of which may be configured to receive each of the magnets of the passive torque element 7004. The disc-shaped body portion 7052 of the magnet support element 7050 of the passive torque element 7004 may have a longitudinal centerline axis that coincides with the centerline axis of the shaft 7022 of the passive torque element 7004. In any embodiment disclosed herein, the magnet support element 7050 of the passive torque element 7004 may include a disk-shaped body 7052, which may include a first recess 7054 formed in the disk-shaped body 7052 configured to receive a first magnet 7024 of the passive torque element 7004, and a second recess 7054 formed in the disk-shaped body 7052 configured to receive a second magnet 7026 of the passive torque element 7004. The disc-shaped main body 7052 of the magnet support element 7050 of the passive torque element 7004 can have a longitudinal centerline axis that coincides with the centerline axis of the shaft 7022 of the passive torque element 7004, so that the disc-shaped main body 7052 of the magnet support element 7050 of the passive torque element 7004 is coaxially aligned with the shaft 7022 of the passive torque element 7004.

[0322] In certain embodiments, the first magnet 7014 (and any other magnets) of the active torque element 7002 can be positioned at a distance from the axis of the shaft 7012 of the active torque element 7002, the centers of the first magnet 7014 (and any other magnets) of the active torque element 7002 are eccentric with respect to the axis of the shaft 7012 of the active torque element 7002, and the first magnet 7014 (and any other magnets) of the active torque element 7002 are configured to rotate in an orbit around the axis of the shaft 7012 of the active torque element 7002. Similarly, the first magnet 7024 (and any other magnets) of the passive torque element 7004 can be positioned at a distance from the axis of the shaft 7022 of the passive torque element 7004, such that the center of the first magnet 7024 (and any other magnets) of the passive torque element 7004 is eccentric with respect to the axis of the shaft 7022 of the passive torque element 7004, and the first magnet 7024 (and any other magnets) of the passive torque element 7004 is configured to rotate in an orbit around the axis of the shaft 7022 of the passive torque element 7004. In any embodiment disclosed herein, the active torque element 7002 and the passive torque element 7004 may each include only two magnets connected to the shafts 7012 of the active torque element 7002 and the passive torque element 7004, or only three magnets connected to the shafts 7012 of the active torque element 7002 and the passive torque element 7004, or only four magnets connected to the shafts 7012 of the active torque element 7002 and the passive torque element 7004.

[0323] In some embodiments, the active torque element 7002 can be configured to be positioned on the non-sterile side of the sterile barrier (e.g., the capital equipment side), and the passive torque element 7004 can be configured to be positioned on the sterile side of the sterile barrier (e.g., the disposable equipment side). Furthermore, in any embodiment disclosed herein, the torque transfer system 7000 can be configured for use in a surgical robot drive system as described herein. For example, the active torque element 7002 can be coupled to a hub adapter, and the passive torque element 7004 can be coupled to a hub in the robot drive system.

[0324] In certain embodiments, the active torque element 7002 may include a motor 7070, which is connected to the shaft 7012 of the active torque element 7002 and configured to selectively apply torque force to the shaft 7012 of the active torque element 7002, thereby rotating the shaft 7012 of the active torque element 7002. In some embodiments, the motor 7070 may be a servomotor. The torque transfer system 7000 may include a controller 7072 (also referred to herein as a control module or control circuit) that electrically communicates with the motor 7070 of the active torque element 7002, as shown in Figure 43P, and the controller 7072 is configured to control the operation of the motor 7070 in response to inputs to the controller 7072. The controller 7072 may be a microcontroller.

[0325] In certain embodiments, the active torque element 7002 may further include a clutch plate 7078 between the shaft 7012 and the motor 7070. The clutch plate 7078 may be configured to limit the magnitude of the torque transferred from the motor 7070 to the shaft 7012. Some embodiments of the active torque element 7002 may further include a ball bearing 7080 around a portion of the shaft 7012 of the active torque element 7002, and the passive torque element 7004 may further include a ball bearing 7080 around a portion of the shaft 7022 of the passive torque element 7004.

[0326] As shown in Figures 43H and 43I, the active torque element 7002 can be connected to or supported by the hub adapter 7005. In some embodiments, the active torque element 7002 can be connected to or supported by a housing 7082 (e.g., of the hub adapter) which may be configured to be at least axially translated. The housing 7082 may be in the form of a support plate.

[0327] Similarly, the passive torque element 7004 can be connected to or supported by the hub 7001. In some embodiments, the passive torque element 7004 can be connected to or supported by a housing 7084 and / or a support plate (e.g., of the hub) or housing 7085, or can be enclosed or partially enclosed within the housing 7084 and / or housing 7085, which may be configured to be at least axially translated.

[0328] In some embodiments, the hub adapter 7005 can be configured to connect to a plurality of active torque elements 7002 (including two, three, four, five, or more than five active torque elements 7002) (for example, via housing 7082). In some embodiments, the hub 7001 can be configured to connect to a plurality of passive torque elements 7004 (including two, three, four, five, or more than five passive torque elements 7004) (for example, via housing 7084 and / or housing 7085).

[0329] In some embodiments, as shown in Figure 43M, the support plate or housing 7082 may include a plurality of recesses 7093, each of which is configured to receive a magnetic support element 7040 of the active torque element 7002. Each of the recesses 7093 may be sized to be slightly larger than the magnetic support element 7040, allowing the magnetic support element 7040 to rotate freely within the recesses 7093.

[0330] Similarly, as shown in Figure 43O, in some embodiments, the support plate or housing 7085 of the passive torque element 7004 may include a plurality of recesses 7095, each configured to receive a magnetic support element 7050 of the passive torque element 7004 therein. Each of the recesses 7095 may be sized slightly larger than the magnetic support element 7050, allowing the magnetic support element 7050 to rotate freely within the recesses 7095. Note that in some figures, for the purpose of clarity, not all aspects of the passive torque element 7004 are shown.

[0331] In some embodiments, as shown in Figure 43M, the hub adapter 7005 may have a plurality of rollers 7089 (e.g., connected to the housing 7082) configured to roll along a sterile barrier. In some embodiments, as shown in Figure 43O, the housing 7085 may have a plurality of rollers 7091 (e.g., connected to the housing 7085) configured to roll along a sterile barrier.

[0332] In some embodiments, as shown in Figures 43N to 43P, the passive torque element 7004 may further include a first gear 7090 connected to the shaft 7022 of the passive torque element 7004, the first gear 7090 being configured to rotate the second gear 7092 when the shaft 7022 of the passive torque element 7004 is rotated. In some embodiments, the first gear 7090 and the second gear 7092 may be miter gears (also referred to as bevel gears). In some embodiments, the second gear 7092 may be connected to a surgical instrument in the rotational and axial directions. As shown in Figures 43N to 43P, the second gear 7092 may be connected to an intervention device 7096 (e.g., a guidewire or catheter as described herein). The intervention device 7096 can be configured to rotate when the second gear 7092 rotates. In certain embodiments, the intervention device 7096 can be a guidewire, an insertion or access catheter, a guide catheter, or a treatment catheter. In some embodiments, the treatment catheter can be a suction catheter, an embolism deployment catheter, a stent deployment catheter, a flow diverter deployment catheter, a diagnostic angiography catheter, a stent retriever catheter, a blood clot retriever, a balloon catheter, a catheter for facilitating percutaneous valve repair or replacement, an ablation catheter, or any other suitable or desired instrument.

[0333] A passive torque element 7004 for rotating an intervention device is shown in Figures 43N and 43O, but it is intended that the passive torque element 7004 can be used to control a variety of surgical instruments, including, for example, additional components and / or functions of a hub 7001. For example, one or more passive torque elements 7004 can be coupled to a valve. The passive torque element 7004 can be configured to rotate the valve to various states (e.g., between open and closed positions). The valve can be a rotary hemostatic valve (RHV) or a stopcock valve. In some embodiments, the passive torque element 7004 can be configured to actuate the RHV between various states, allowing and / or restricting the movement of an intervention device through it, as well as allowing and / or preventing fluid flow through it. For example, the RHV may be operable between a first fully open state, a second partially open (low sealing force state) that seals around the intervention device but allows for sliding movement of the intervention device, a third state that seals around the intervention device for high-pressure management, and a fourth fully closed state in which no intervention devices extend through it.

[0334] In some embodiments, the passive torque element 7004 can be configured to be connected to a guidewire, and the passive torque element 7004 or another passive torque element 7004 can be configured to selectively deflect at least the distal portion of the guidewire when the passive torque element 7004 is rotated. In some embodiments, the passive torque element 7004 can be configured to be connected to a catheter, and the passive torque element 7004 or another passive torque element 7004 can be configured to selectively deflect at least the distal portion of the catheter when the passive torque element 7004 is rotated. In some embodiments, the passive torque element 7004 can be configured to selectively activate the function of an intervention device (e.g., suction, fluid delivery, etc.).

[0335] As described herein, the hub 7001 and hub adapter 7005 may be part of a robotic drive system, and the robotic drive system may include multiple combinations of hubs 7001 and hub adapter 7005 for coupling with different intervention devices. For example, one or more of the hubs of an intervention device assembly 2900 may be hubs 7001 configured to be coupled to a hub adapter 7005 to enable magnetic torque transmission.

[0336] The hub 7001 can be configured to be positioned on the sterile side of the sterile barrier and can be configured to adjust the axial position of the intervention device. The hub adapter 7005 can be configured to be positioned on the non-sterile side of the sterile barrier and can be configured to move in at least one direction based on input provided by the user of the robotic drive system.

[0337] Any embodiment of the drive system disclosed herein may have a plurality of torque transfer systems 7000 configured similarly to any one of the embodiments disclosed herein. In some embodiments, each active torque element 7002 of the plurality of torque transfer systems 7000 may be connected to a hub adapter, and each passive torque element 7004 of the plurality of torque transfer systems 7000 may be connected to one or more hubs of the embodiments of the robot drive system disclosed herein.

[0338] For example, with respect to Figure 4, as described herein, the hub adapter 7005 may further include a drive magnet, which is configured to be coupled to a driven magnet of the hub 7001, such that when the driven magnet is magnetically coupled to the drive magnet, the driven magnet and the hub 7001 move axially in response to the movement of the drive magnet.

[0339] In any embodiment disclosed herein, the robot drive system may include at least three or at least four hub adapters (e.g., hub adapter 7005), at least four hubs (e.g., hub 7001), and a plurality of torque transfer systems 7000 configured similarly to any one of the embodiments disclosed herein, wherein the three or at least four hub adapters (e.g., hub adapter 7005) are each configured to be positioned on the non-sterile side of a sterile barrier and to move in at least one direction based on inputs provided by a user of the robot drive system, and the at least four hubs (e.g., hub 7001) are each configured to be positioned on the sterile side of a sterile barrier and to adjust the axial position of an intervention device. Each of the at least three or at least four hub adapters may have at least one active torque element 7002 connected to the hub adapter, and each of the at least three or at least four hubs may have at least one passive torque element 7004 connected to the hub. In some embodiments, each of at least three or at least four hub adapters may have a plurality of active torque elements 7002 connected to the hub adapter, and each of at least three or at least four hubs may have a plurality of passive torque elements 7004 connected to the hub.

[0340] In certain embodiments, the first magnet 7014 of the active torque element 7002 and the first magnet 7024 of the passive torque element 7004 may have diameters of 0.25 inches or approximately 0.25 inches, 0.375 inches or approximately 0.375 inches, or 0.5 inches or approximately 0.5 inches, respectively. In certain embodiments, the first magnet 7014 of the active torque element 7002 may be positioned 0.4 inches or approximately 0.4 inches away from the centerline axis of the shaft 7012, or from the center (e.g., radial center) of the magnet support element 7040 of the active torque element 7002. In certain embodiments, the first magnet 7024 of the passive torque element 7004 can be positioned 0.4 inches or approximately 0.4 inches away from the centerline axis of the shaft 7022, or from the center (e.g., radial center) of the magnet support element 7050 of the passive torque element 7004. In certain embodiments, the first magnet 7014 of the active torque element 7002 can be positioned 0.25 inches or approximately 0.25 inches to 1 inch or approximately 1 inch away from the centerline axis of the shaft 7012, or from the center (e.g., radial center) of the magnet support element 7040 of the active torque element 7002. In certain embodiments, the first magnet 7024 of the passive torque element 7004 can be positioned at a distance of 0.25 inches or approximately 0.25 inches to 1 inch or approximately 1 inch from the centerline axis of the shaft 7022, or from the center (e.g., radial center) of the magnet support element 7050 of the passive torque element 7004.

[0341] Also disclosed herein are embodiments of a method for rotating a surgical device located on the sterile side of a sterile barrier. Some embodiments of this method may include the steps of: magnetically connecting an active torque element 7002, positioned on the non-sterile side of the sterile barrier, to a passive torque element 7004, positioned on the sterile side of the sterile barrier; connecting an instrument (e.g., an intervention device) to the passive torque element 7004; and rotating the active torque element 7002, thereby rotating the passive torque element 7004, which is magnetically connected to the active torque element 7002, and rotating the instrument connected to the passive torque element 7004. In some embodiments, the intervention device may be a catheter or a guidewire.

[0342] Some embodiments of this method may include the step of rotating the passive torque element 7004 to move the seal around the catheter between various states as described herein. Also disclosed herein are embodiments of a method for performing a neurovascular procedure. Some embodiments of this method may include the step of providing an intervention device assembly which may include a guidewire, an access catheter, a guide catheter, and / or a procedure catheter. This method may include one or more of the following steps: connecting a guidewire to a first passive torque element 7004 positioned on the sterile side of a sterile barrier; connecting an access catheter to a second passive torque element 7004 positioned on the sterile side of a sterile barrier; connecting a procedure catheter to a third passive torque element 7004 positioned on the sterile side of a sterile barrier; and connecting a guide catheter to a fourth passive torque element 7004. This method may include one or more of the following steps: magnetically connecting a first active torque element 7002 to a first passive torque element 7004; magnetically connecting a second active torque element 7002 to a second passive torque element 7004; magnetically connecting a third active torque element 7002 to a third passive torque element 7004; and magnetically connecting a fourth active torque element 7002 to a fourth passive torque element. This method may also include one or more of the following steps: rotating a guidewire by rotating the first active torque element 7002; rotating an access catheter by rotating the second active torque element 7002; rotating a treatment catheter by rotating the third active torque element 7002; and rotating a guide catheter by rotating the fourth active torque element 7002.In some embodiments, the first, second, third, and fourth active torque elements 7002 are each independently movably supported by separate hub adapters. In some embodiments, the treatment catheter can be a suction catheter, an embolism deployment catheter, a stent deployment catheter, a flow diverter deployment catheter, a diagnostic angiography catheter, a stent retriever catheter, a blood clot retriever, a balloon catheter, a catheter for facilitating percutaneous valve repair or replacement, or an ablation catheter.

[0343] Figure 44A shows a portion of an embodiment of a torque transfer system 7100 that may be configured to transfer torque force through a sterile barrier. The torque transfer system 7100 may have any of the same or similar features and / or functions as any of the other torque transfer systems described herein, and vice versa. In some embodiments, the torque transfer system 7100 may include an active torque element (e.g., a first active torque element 7102A) configured to be positioned on the non-sterile side (e.g., capital equipment side) of the sterile barrier, and a passive torque element (e.g., a first passive torque element 7104A) configured to be positioned on the sterile side (e.g., disposable equipment side) of the sterile barrier. The active torque element may have any of the same or similar features and / or functions as any of the other active torque elements described herein, and vice versa. The passive torque element may have any of the same or similar features and / or functions as any of the other passive torque elements described herein, and vice versa. Figures 44A and 44B illustrate typical magnetic connections between the first active torque element 7102A and the first passive torque element 7104A. These magnetic connections can represent any magnetic connection between the active and passive torque elements.

[0344] In some embodiments, the active torque element 7102A may include a plurality of magnets arranged around a central axis (represented by axis A13 in Figure 44A). The plurality of magnets may include one or more first magnets 7114 and one or more second magnets 7116. One or more first magnets 7114 may include a north pole or a positive pole facing axially toward the passive torque element. One or more second magnets 7116 may include a south pole or a negative pole facing axially toward the passive torque element. The magnets 7114 and 7116 may be wedge-shaped magnets. In some embodiments, wedge-shaped magnets may provide a larger magnetic surface area on the magnet support element compared to disk-shaped magnets positioned on the same magnet support element.

[0345] In some embodiments, the multiple magnets of the active torque element 7102A can be arranged in a planar configuration on a plane parallel or generally parallel to the sterile barrier.

[0346] The passive torque element may include a plurality of magnets arranged around a central axis (e.g., axis A13). The plurality of magnets may include one or more first magnets 7154 and one or more second magnets 7156. The one or more first magnets 7154 may include a south pole or negative pole facing axially toward the active torque element. The one or more second magnets 7156 may include a north pole or positive pole facing axially toward the active torque element. The magnets 7154 and 7156 may be wedge-shaped magnets. In some embodiments, the plurality of magnets of the passive torque element may be arranged in a planar configuration on a plane parallel or generally parallel to the sterile barrier.

[0347] The first magnet 7114 of the active torque element 7102A can be magnetically connected to the first magnet 7154 of the passive torque element 7104A, and the second magnet 7116 of the active torque element 7102A can be connected to the second magnet 7156 of the passive torque element 7104A. The rotation of the multiple magnets of the active torque element 7102A around the central axis of the multiple magnets of the active torque element can cause a corresponding rotation of the multiple magnets of the passive torque element 7104A around the central axis of the multiple magnets of the passive torque element.

[0348] In some embodiments, the central axes of the multiple magnets of the active torque element 7102A can be coaxial with or parallel to the central axes of the multiple magnets of the passive torque element 7104. In some embodiments, the central axes of the multiple magnets of the active torque element 7102A, and / or the central axes of the multiple magnets of the passive torque element 7104A, can be transverse (e.g., perpendicular) to the direction of axial movement of the hub adapter, hub, and / or intervention device to which the components of the torque transfer system 7100 are connected.

[0349] As shown in Figure 44A, in some embodiments, the active torque element 7102A may include a magnet support element 7140. The magnet support element 7140 may be configured to support multiple magnets of the active torque element. For example, the magnet support element 7140 may be configured to support multiple magnets of the active torque element in a radially planar arrangement around the central axis of the multiple magnets (e.g., axis A13). In some embodiments, the magnet support element 7140 may be formed from an iron-based material (e.g., steel) which may direct magnetic field lines away from the magnet support element 7140 (e.g., towards the passive torque element).

[0350] In some embodiments, the passive torque element 7104A may include a magnet support element 7150. The magnet support element 7150 may be configured to support multiple magnets of the passive torque element 7104A. For example, the magnet support element 7150 may be configured to support multiple magnets of the passive torque element 7104A in a radially planar arrangement around the central axis of the multiple magnets (e.g., axis A13). In some embodiments, the magnet support element 7150 may be formed from an iron-based material (e.g., steel) and it may be possible to direct magnetic field lines away from the magnet support element 7150 (e.g., towards the active torque element 7102A).

[0351] In some embodiments, the magnet support element 7140 and / or multiple magnets of the active torque element 7102A can be rotated (e.g., by a motor) to cause rotation of the multiple magnets and / or magnet support element 7150 of the passive torque element 7104A. As described herein, the multiple magnets and / or magnet support element 7150 of the passive torque element 7104A can be coupled to surgical instruments (e.g., intervention devices, valves,...

Claims

1. A hub assembly for an intervention device driven by robot control, An intervention device hub with an intervention device; At least one magnet, Includes, A hub assembly is positioned on the sterile side of a sterile field barrier and configured to magnetically connect to the hub adapter on the non-sterile side of the sterile field barrier, such that the hub assembly moves axially in response to the axial movement of the hub adapter, and at least one of the magnets of the hub assembly rotates in response to the rotation of at least one of the magnets of the hub adapter.

2. The hub assembly according to claim 1, wherein at least one of the magnets of the hub assembly is configured to be operably connected to the intervention device, and the rotation of at least one of the magnets of the hub assembly causes the rotation of the intervention device.

3. The hub assembly according to claim 2, wherein at least one of the magnets is configured to rotate about an axis transverse to the rotation axis of the intervention device.

4. The hub assembly according to claim 1, wherein at least one of the magnets of the hub assembly is configured to connect to a valve of the fluid engineering subsystem of the hub assembly.

5. The hub assembly according to claim 4, wherein the valve is a hemostatic valve, and the rotation of at least one of the magnets of the hub assembly is configured to move the hemostatic valve between an open configuration and a closed configuration.

6. The hub assembly according to claim 4, wherein the valve is configured to selectively facilitate the flow of fluid to or from the intervention device.

7. The hub assembly according to claim 6, wherein the valve is a three-way valve connected to a first flow path for vacuum and a second flow path for saline solution and contrast agent.

8. The hub assembly according to claim 1, wherein at least one of the magnets includes a polymagnet having a plurality of magnetic regions.

9. The hub assembly according to claim 1, wherein the hub assembly is configured to move axially in response to a magnetic force applied to at least one of the magnets of the hub assembly by at least one of the magnets of the hub adapter.

10. The hub assembly according to claim 1, wherein at least one of the magnets of the hub assembly comprises a plurality of magnets, at least one of the magnets of the hub adapter comprises a plurality of magnets, and each of the plurality of magnets of the hub assembly is configured to rotate in response to the rotation of one of the plurality of magnets of the hub adapter.

11. The hub assembly according to claim 10, wherein the plurality of magnets in the hub assembly include a first magnet and a second magnet, the first magnet being connected to the intervention device such that the rotation of the first magnet causes the rotation of the intervention device, and the second magnet being connected to a valve of a fluid engineering subsystem.

12. The hub assembly according to claim 1, wherein the hub assembly includes one or more detectable objects configured to be detected by one or more sensors located on the non-sterile side of the sterile field barrier.

13. The hub assembly according to claim 1, wherein the hub assembly includes a passive torque element, the passive torque element includes at least one of the magnets of the hub assembly and a magnet support, the at least one of the magnets of the hub assembly is mounted on the magnet support, and the passive torque element is configured to rotate in response to the rotation of at least one of the magnets of the hub adapter.

14. The hub assembly according to claim 13, wherein the magnet support is formed from an iron-based material.

15. The hub assembly according to claim 13, wherein at least one of the magnets and the magnet support of the hub assembly are each disk-shaped.

16. The hub assembly according to claim 1, comprising a mount and an intervention device hub detachably connected to the mount.

17. The hub assembly according to claim 16, wherein at least one of the magnets of the hub assembly is attached to the mount.

18. The hub assembly according to claim 1, wherein at least one of the magnets of the hub assembly is configured to rotate about a rotation axis, and the hub assembly is configured to move axially along a transverse axis with respect to the rotation axis of at least one of the magnets of the hub assembly.

19. The hub assembly according to claim 1, comprising a plurality of rollers configured to contact a drive surface.

20. The hub assembly according to claim 19, wherein the plurality of rollers are configured to be positioned at a distance from the drive surface of at least one of the magnets of the hub assembly.

21. A robotic drive system, It includes a hub adapter positioned on the non-sterile side of the sterile field barrier and configured to move axially, The hub adapter includes at least one magnet, A robotic drive system in which the hub adapter is configured to connect to a hub assembly on the sterile side of the sterile field barrier, the axial movement of the hub adapter causes the axial movement of the hub assembly, and the rotational movement of at least one of the magnets of the hub adapter causes the rotational movement of at least one magnet of the hub assembly.

22. The robot drive system according to claim 21, wherein the hub adapter is configured to translate axially along a first axis, and the hub adapter includes a frame configured to translate axially along a second axis transverse to the first axis.

23. The robot drive system according to claim 22, wherein at least one of the magnets of the hub adapter is configured to rotate about a third axis, the third axis being parallel to the second axis.

24. The robot drive system according to claim 22, wherein the hub adapter is configured to move axially along a drive surface, the hub adapter further comprises a spring assembly, the spring assembly comprises one or more springs, the one or more springs are configured to bias at least one of the magnets of the hub adapter and to maintain an air gap between at least one of the magnets and the drive surface.

25. The robot drive system according to claim 21, wherein at least one of the magnets of the hub adapter includes a polymagnet having a plurality of magnetic regions.

26. At least one of the magnets in the hub adapter includes a plurality of magnets, At least one of the magnets in the hub assembly includes a plurality of magnets, The robot drive system according to claim 21, wherein each of the plurality of magnets of the hub adapter is configured to rotate in such a way that it causes one of the plurality of magnets of the hub assembly to rotate.

27. The hub adapter includes an active torque element, The active torque element includes at least one of the magnets of the hub adapter and a magnet support, At least one of the magnets of the hub adapter is attached to the magnet support, The robot drive system according to claim 21, wherein the active torque element is configured to rotate to cause rotation of at least one of the magnets of the hub assembly.

28. The robot drive system according to claim 27, wherein the magnet support is formed from an iron-based material.

29. The robot drive system according to claim 27, wherein at least one of the magnets and the magnet support of the hub adapter are each disk-shaped.

30. The robot drive system according to claim 21, wherein the hub adapter includes a plurality of rollers configured to contact the drive surface.

31. The robot drive system according to claim 30, wherein the plurality of rollers are configured to position at least one of the magnets of the hub adapter at a distance from the drive surface.

32. The robot drive system according to claim 21, wherein at least one of the magnets of the hub adapter is configured to rotate about a rotation axis, and the hub adapter is configured to move axially along a transverse axis with respect to the rotation axis of at least one of the magnets of the hub adapter.

33. The robot drive system according to claim 21, further comprising the hub assembly.

34. The robot drive system according to claim 33, wherein at least one of the magnets of the hub assembly is configured to be connected to an intervention device of the hub assembly, and the rotation of at least one of the magnets of the hub assembly causes the rotation of the intervention device.

35. The robot drive system according to claim 33, wherein at least one of the magnets of the hub assembly is configured to be connected to a valve of the fluid engineering subsystem of the hub assembly.

36. The robot drive system according to claim 35, wherein the valve is a hemostatic valve, and the rotation of at least one of the magnets of the hub assembly is configured to move the hemostatic valve between an open configuration and a closed configuration.

37. The robot drive system according to claim 35, wherein the valve is configured to selectively facilitate the flow of fluid to or from the intervention device.

38. The robot drive system according to claim 33, wherein the hub assembly is configured to move axially in response to a magnetic force applied to at least one of the magnets of the hub assembly by at least one of the magnets of the hub adapter.

39. The robot drive system according to claim 33, wherein the hub assembly includes one or more detectable objects, and the hub adapter includes one or more sensors configured to detect one or more of the detectable objects.

40. The robotic drive system according to claim 33, wherein the hub assembly includes a mount and an intervention device hub detachably connected to the mount.

41. A robotic drive system, With at least one magnet positioned on the non-sterile side of the sterile field barrier; Frame and, Includes, At least one of the magnets is connected to the frame, The frame is configured to move from a retracted position to an extended position. A robotic drive system in which at least one of the magnets is positioned closer to the sterile field barrier in the extended position than in the retracted position.

42. The robot drive system further includes a hub adapter, The hub adapter includes at least one of the magnets and the frame, The robot drive system according to claim 41, wherein the hub adapter is configured to move axially along the drive surface.

43. The hub adapter includes a spring assembly, The spring assembly includes one or more springs, The robot drive system according to claim 42, wherein one or more springs are configured to bias at least one magnet and maintain an air gap between at least one magnet and the drive surface when the frame is in the extended position.

44. The hub adapter is configured to translate axially along the first axis, The robot drive system according to claim 42, wherein the frame is configured to translate axially along a second axis transverse to the first axis between the retracted position and the extended position.

45. At least one of the magnets of the hub adapter is configured to rotate about a third axis, The robot drive system according to claim 44, wherein the third axis is parallel to the second axis.

46. The robot drive system according to claim 42, wherein the hub adapter includes a support assembly configured to maintain a minimum air gap between at least one of the magnets and the drive surface.

47. The robot drive system according to claim 46, wherein the support assembly includes a plurality of rollers.

48. A robotic drive system, Including the torque transfer system, The aforementioned torque transfer system is An active torque element positioned on the non-sterile side of a sterile field barrier, comprising an active torque element including at least one magnet; A passive torque element positioned on the sterile side of the sterile field barrier, comprising at least one magnet and configured to be connected to an intervention device, and Includes, A robotic drive system in which the active torque element is configured to rotate in such a way that it applies torque to the passive torque element, thereby rotating the passive torque element and the intervention device.

49. The robot drive system further includes a hub assembly configured to be positioned on the sterile side of the sterile field barrier, The robot drive system according to claim 48, wherein the passive torque element is connected to the hub assembly.

50. The robot drive system according to claim 48, wherein the passive torque element is configured to rotate about a rotation axis perpendicular to the rotation axis of the intervention device.

51. A method for rotating a surgical device located on the sterile side of a sterile field barrier, A step of magnetically connecting an active torque element positioned on the non-sterile side of the sterile field barrier to a passive torque element positioned on the sterile side of the sterile field barrier, wherein the passive torque element is connected to the surgical device; The steps of rotating the active torque element, thereby rotating the passive torque element which is magnetically connected to the active torque element, and the surgical device which is connected to the passive torque element. Methods that include...

52. A method for performing vascular procedures, A step of providing a multi-catheter assembly including an access catheter, wherein the access catheter is connected to a first passive torque element positioned on the sterile side of a sterile field barrier; The steps include: magnetically connecting the first active torque element to the first passive torque element; The steps include rotating the access catheter by rotating the first active torque element, and Methods that include...

53. A method for performing vascular procedures, The steps include: magnetically connecting a hub assembly having an intervention device on the sterile side of a sterile field barrier to a hub adapter on the non-sterile side of the sterile field barrier; The steps include rotating at least one magnet of the hub adapter and causing rotation of at least one magnet of the hub assembly. Methods that include...

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