Magnetic connection through sterile area barrier

Abstract

A hub assembly for a robotically operated driven interventional device may include an interventional device hub having an interventional device and at least one magnet. The hub assembly may be configured to be located on a sterile side of the sterile zone barrier and magnetically connected with a hub adapter on a non-sterile side of the sterile zone barrier such that the hub assembly axially moves in response to axial movement of the hub adapter and the at least one magnet of the hub assembly rotates in response to rotation of the at least one magnet of the hub adapter.

Description

[0001] Cross-references to related applications

[0002] Pursuant to 37 CFR §1.57, any and all applications that identify foreign and domestic priority claims in the application data sheet filed with this application are hereby incorporated by reference. This application claims priority to U.S. Provisional Patent Application No. 63 / 470,115, filed May 31, 2023, entitled "MAGNETIC COUPLING FOR TORQUE TRANSMISSION THROUGH A STERILE BARRIER," the entire contents of which are incorporated herein by reference for all purposes and form part of this specification. Technical Field

[0003] This application relates to neurovascular surgery, and more specifically, to catheter assemblies and robotic control systems for access to neurovascular sites. Background Technology

[0004] Various neurovascular procedures can be performed via transvascular access, including thrombectomy, diagnostic angiography, embolization coil deployment, and stent placement. However, the delivery of neurovascular care is limited or delayed by a number of challenges. For example, there is a lack of trained interventional therapists and medical centers to meet the current demand for neurointervention. Neurointervention is difficult, placing complex conditions and demands on the surgeon's dexterity. The surgeon must precisely control three to four coaxial catheters with both hands while managing the fluoroscopic system and patient positioning. Long, curved anatomy requires delicate and accurate manipulation. Unintentional catheter movement can occur due to energy storage and release caused by frictional interactions between the coaxial system and the patient's vascular system. Achieving supra-aortic access, necessary to reach the neurovascular system, is challenging, especially for type III arches. Once supra-aortic access is achieved, adapting the system to neurovascular treatment is time-consuming and requires guidewire removal and access catheterization, and adding surgical catheters (and possibly one or more additional catheters) to the stack.

[0005] Therefore, there remains a need for systems with supra-aortic and neurovascular access that address some or all of these challenges and increase the availability of neurovascular surgery. Preferably, the system is additionally capable of driving further distally via supra-aortic access to perform surgery within intracranial vessels. Summary of the Invention

[0006] This document discloses innovations and implementation schemes for robotic drive systems used in interventional procedures. Some implementations of the robotic drive systems disclosed herein may use a hub adapter (also referred to herein as a trolley) to move a hub (also referred herein as a small circular element (puck) or instrument connector) located on the sterile side of a sterile barrier, wherein one or more surgical instruments are connected to the hub. In some implementations, a magnetic field can be generated between the hub adapter and the hub, such that movement of the hub adapter causes movement of the hub due to the magnetic field between the hub and the hub adapter. This is a solution for controlling the movement of the hub of a robotic surgical system through a sterile barrier. In other words, a magnetic connection can be used in any implementation of the robotic surgical system disclosed herein, such that movement of the drive device on the non-sterile side of the sterile barrier can cause movement of at least one device on the sterile side of the sterile barrier in any desired direction of movement (e.g., in the insertion and / or withdrawal direction of the instrument relative to the port into the patient's body), in order to move the instrument on the sterile side of the sterile barrier.

[0007] This document also discloses innovations and embodiments of magnetic torque transmission units or systems that can be used to transmit torque loads through a sterile barrier to rotate instruments (e.g., but not limited to, catheters, guidewires, or other devices) configured for insertion 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 to herein as a sterile-side torque device). Such a device can be configured such that rotation of the active torque element on the non-sterile side of the sterile barrier will cause the passive torque element and the instrument connected thereto to rotate substantially simultaneously. Due to the arrangement of the active torque element relative to the passive torque element, the passive torque element will rotate in the opposite direction to the rotation of the active torque element, similar to a pair of meshing 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 may each have a magnetic element having multiple opposite poles. The magnetic element can comprise a single magnet with multiple different poles (e.g., but not limited to 4, 6, or 12) or multiple individual magnets with alternating opposite poles, such that the north pole of the magnet, or a portion of the magnet on the active torque element, attracts the south pole of the magnet, or a portion of the magnet on the passive torque element. When the magnetic element of the active torque element rotates, the magnetic force along the shear direction will cause the magnetic element of the passive torque element to rotate. This arrangement can significantly reduce the complexity and cost of the machine actuator and the overall robot drive system.

[0008] This document discloses implementation schemes for robot drive systems. Some implementations of the robot drive system may include a torque transmission system, which may include an active torque element located on the non-sterile side of a sterile barrier and a passive torque element located 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 connect to an interventional device. The active torque element may be configured to rotate to apply torque to the passive torque element, thereby causing the passive torque element and the interventional device to rotate.

[0009] In additional embodiments, any embodiment of the robot drive system, its apparatus, and / or method of using any embodiment of the robot drive system disclosed herein may, but is 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: wherein the active torque element includes a plurality of magnets arranged in the periphery of the active torque element; wherein the passive torque element includes a plurality of magnets arranged in the periphery of the passive torque element; wherein the robot drive system includes an electric motor connected to and configured to rotate the active torque element. A torque element; wherein the robot drive system includes a microcontroller electrically connected to an electric motor; wherein the robot drive system includes a hub configured on the sterile side of a sterile barrier, wherein a passive torque element is connected to the hub; wherein the robot drive system includes a hub adapter configured on the non-sterile side of the sterile barrier, wherein an active torque element is connected to the hub adapter; wherein the interventional device is a guidewire, access catheter, guiding catheter, or surgical catheter; wherein at least one magnet of the passive torque element can be configured to rotate about an axis transverse to the rotational axis of the interventional device; wherein the active torque element can be configured to rotate about an axis transverse to the rotational axis of the interventional device. Rotation; wherein the passive torque element includes a plurality of disk-shaped magnets; wherein the active torque element includes a plurality of disk-shaped magnets; wherein the active torque element includes a plurality of arc-shaped magnets arranged near the periphery of the active torque element; wherein the active torque element includes a plurality of magnets arranged near the periphery of the active torque element, and wherein the polarities of the magnetic fields of the plurality of magnets alternate, the magnetic fields extending radially outward from each of the plurality of magnets; wherein the passive torque element includes a plurality of arc-shaped magnets arranged near the periphery of the passive torque element; wherein the passive torque element includes a plurality of magnets arranged near the periphery of the passive torque element, and wherein the polarities of the magnetic fields of the plurality of magnets alternate, the magnetic fields extending radially outward from each of the plurality of magnets. Each of the plurality of magnets extends radially outward; wherein at least one magnet of the active torque element includes a plurality of poles extending away from the periphery of the active torque element; wherein the plurality of poles alternate between a north pole and a south pole around the periphery of at least one magnet of the active torque element; wherein at least one magnet of the passive torque element includes a plurality of poles extending away from the periphery of the passive torque element; wherein the plurality of poles alternate between a north pole and a south pole around the periphery of at least one magnet of the passive torque element; wherein the passive torque element can be configured to rotate about an axis parallel to the rotation axis of the interventional device; and / or wherein the active torque element can be configured to rotate about an axis parallel to the rotation axis of the interventional device.

[0010] In any embodiment of the robot drive system disclosed herein, the active torque element may include a plurality of positive magnetic fields extending radially from the periphery of the active torque element and a plurality of negative magnetic fields extending radially from the periphery of the active torque element, wherein each of the plurality of negative magnetic fields of the active torque element is located between two positive magnetic fields of the active torque element, wherein the passive torque element includes a plurality of positive magnetic fields extending from the periphery of the passive torque element and a plurality of negative magnetic fields extending from the periphery of the passive torque element, and wherein each of the plurality of negative magnetic fields of the passive torque element is located between two positive magnetic fields of the passive torque element.

[0011] This document also discloses embodiments of a torque transmission system. In some embodiments, the torque transmission system may include an active torque element configured to be located on the non-sterile side of a sterile barrier and a passive torque element configured to be located on the sterile side of the sterile barrier. The passive torque element may include a shaft 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 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 transmission system may be configured such that the first magnet of the passive torque element is magnetically connected to the first magnet of the active torque element. The torque transmission system may 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, rotation of the shaft of the active torque element about the axis of the active torque element will result in a torque being applied to the shaft of the passive torque element, said torque biasing the passive torque element to rotate about the axis of the passive torque element.

[0012] In additional embodiments, any embodiment of the torque transmission system, its apparatus, and / or method of using any embodiment of the torque transmission system disclosed herein may, but is 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: wherein 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; wherein the active torque element further includes a second magnet, the second magnet being attracted to the first magnet of the active torque element. The passive torque element includes a first magnet spaced apart from and spaced apart from the centerline axis of the active torque element; the passive torque element further includes a second magnet spaced apart from the first magnet of the passive torque element and spaced apart from the centerline axis of the passive torque element; the torque transmission system is configured such that the second magnet of the passive torque element is magnetically connected to the second magnet of the active torque element; the second magnet of the active torque element has opposite polarity to the first magnet of the active torque element, and the second magnet of the passive torque element has opposite polarity to the first magnet of the passive torque element; the second magnet of the passive torque element is connected to the first magnet of the active torque element. The second magnet of the active torque element has opposite polarity, causing the second magnet of the passive torque element to be attracted to the second magnet of the active torque element; wherein the active torque element includes a plurality of magnets, each said magnet being radially spaced apart from each other and radially spaced apart from the centerline axis of the shaft of the active torque element, wherein the passive torque element includes a plurality of magnets, each said magnet being radially spaced apart from each other and radially spaced apart from 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 aligned and magnetically connected to each of the plurality of magnets of the passive torque element; wherein the active torque element also includes A second magnet and a third magnet, the second magnet and the third magnet being spaced apart from each other and spaced apart from the first magnet of the active torque element and spaced apart from the centerline axis of the shaft of the active torque element, wherein the passive torque element further includes a second magnet and a third magnet, the second magnet and the third magnet being spaced apart from each other and 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, and wherein the torque transmission system can be configured such that the second magnet of the passive torque element is magnetically connected to the second magnet of the active torque element and the third magnet of the passive torque element is magnetically connected to the third magnet of the active torque element;The active torque element further includes a fourth magnet, which is spaced apart from the first, second, and third magnets of the active torque element and spaced apart from the centerline axis of the active torque element's shaft. The passive torque element also includes a fourth magnet, which is spaced apart from the first, second, and third magnets of the passive torque element and spaced apart from the centerline axis of the passive torque element's shaft. The torque transmission system is further configured such that the fourth magnet of the passive torque element is magnetically connected 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, and the magnet support element of the active torque element is configured to support a plurality of magnets radially and planarly around the centerline axis of the shaft of the active torque element. The passive torque element also includes a magnet support element connected to the distal end of the shaft of the passive torque element, and the magnet support element of the passive torque element is configured to support a plurality of magnets radially and planarly around the centerline axis of the shaft of the passive torque element. The device supports multiple magnets, wherein each of the multiple magnets of the active torque element can be configured to be aligned and magnetically connected to each of the multiple magnets of the passive torque element; wherein the magnet support element of the active torque element includes a disk-shaped body and multiple recesses formed in the disk-shaped body; wherein each of the multiple recesses formed in the disk-shaped body of the active torque element can be configured to receive each of the magnets of the active torque element therein; and wherein the disk-shaped body of the magnet support element of the active torque element has a longitudinal centerline axis aligned with the centerline axis of the shaft of the active torque element; wherein the magnet support element of the active torque element includes a disk-shaped body, the disk-shaped body including a first recess formed in the disk-shaped body and a second recess formed in the disk-shaped body, the first recess being configured to receive a first magnet of the active torque element, and the second recess being configured to receive a second magnet of the active torque element; and / or wherein the disk-shaped body of the magnet support element of the active torque element has a longitudinal centerline axis aligned with the centerline axis of the shaft of the active torque element.

[0013] In additional embodiments, any embodiment of the torque transmission system, its apparatus, and / or method of using any embodiment of the torque transmission system disclosed herein may, but is 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: wherein the magnet support element of the passive torque element has a disc-shaped body and a plurality of recesses formed in the disc-shaped body; wherein each of the plurality of recesses formed in the disc-shaped body of the passive torque element can be configured to receive each of the magnets of the passive torque element therein; wherein the disc-shaped body of the magnet support element of the passive torque element has a longitudinal centerline axis aligned with the centerline axis of the shaft of the passive torque element; wherein the magnet support element of the passive torque element includes a disc-shaped body, the disc... The disc-shaped body includes a first recess formed in the disc-shaped body and a second recess formed in the disc-shaped body. The first recess is configured to receive a first magnet of the passive torque element, and the second recess is configured to receive a second magnet of the passive torque element. The disc-shaped body of the magnet support element of the passive torque element has a longitudinal centerline axis that is aligned with the centerline axis of the passive torque element's shaft. The first magnet of the active torque element is spaced apart from the axis of the active torque element's shaft such that the center of the first magnet of the active torque element is off-center from the axis of the active torque element's shaft. The first magnet of the active torque element can be configured to rotate in a track about the axis of the active torque element's shaft. The first magnet of the passive torque element is spaced apart from the axis of the passive torque element's shaft such that the center of the first magnet of the passive torque element is off-center from the axis of the passive torque element's shaft.The passive torque element has a first magnet configured to rotate in a track about the axis of its shaft; the active torque element and the passive torque element each include only two magnets connected to their respective shafts; the robot drive system includes a motor connected to and configured to rotate the active torque element; the active torque element also includes a driven disk between the shaft and the motor, configured to limit the magnitude of the torque transmitted from the motor to the shaft; the robot drive system includes a controller electrically communicating with the motor of the active torque element, configured to control the operation of the motor in response to inputs to the controller; the active torque element also includes a ball bearing about a portion of its shaft, and the passive torque element also includes a ball bearing about a portion of its shaft; the active torque element is connected to a housing configured to translate at least axially; the passive torque element also includes a first gear connected to the shaft of the passive torque element, configured to engage with and rotate a second gear when the shaft of the passive torque element rotates; the first gear and the second gear are equal-diameter bevel gears. The second gear is rotatably and axially connected to the interventional device, which is configured to rotate when the second gear rotates; a passive torque element may be configured to be connected to the interventional device; the interventional device is a guidewire, guiding catheter, access catheter, or surgical catheter; the surgical catheter is an aspiration catheter, embolization deployment catheter, stent deployment catheter, flow diverter deployment catheter, diagnostic angiography catheter, stent retrieval catheter, clot retrieval device, balloon catheter, catheter facilitating percutaneous flap repair or replacement, or ablation catheter; the passive torque element may be configured to be connected to a valve, and the passive torque element may be configured to rotate the valve between an open and closed position; the valve is a rotary hemostatic valve or a stopcock valve. (valve); wherein the first magnet of the active torque element is spaced 0.4 inches or about 0.4 inches from the centerline of the shaft of the active torque element, and the first magnet of the passive torque element is spaced 0.4 inches or about 0.4 inches from the centerline of the shaft of the passive torque element; wherein the first magnet of the active torque element is spaced 0.25 inches or about 0.25 inches to 1 inch or about 1 inch from the centerline of the shaft of the active torque element, and the first magnet of the passive torque element is spaced 0.25 inches or about 0.25 inches to 1 inch or about 1 inch from the centerline of the shaft of the passive torque element; and / or wherein the first magnet of the active torque element and the first magnet of the passive torque element each have a diameter of 0.25 inches or about 0.25 inches, or 0.375 inches or about 0.375 inches, or 0.5 inches or about 0.5 inches; This document also discloses embodiments of robot drive systems. Any embodiment of the robot drive system disclosed herein may include a hub adapter configured to be located on the non-sterile side of a sterile barrier and configured to move axially based on input provided by a user of the robot drive system; a hub configured to be located on the sterile side of a sterile barrier and configured to move axially in response to the axial movement of the hub adapter to adjust the axial position of an interventional device connected thereto; and one or more torque transmission systems configured as described in the embodiments of the torque transmission systems disclosed herein. In some embodiments, the active torque element of each of the one or more torque transmission systems may be connected to the hub adapter, and the passive torque element of each of the one or more torque transmission systems may be connected to the hub.

[0014] In some implementations, one or more torque transmission systems may include multiple torque transmission systems. Furthermore, some implementations of the robot drive system may include a drive magnet connected to a hub adapter and configured to connect to a driven magnet connected to the hub, such that when the driven magnet is connected to the drive magnet to axially move the hub, the driven magnet moves in response to the movement of the drive magnet.

[0015] This document also discloses an embodiment of a method for rotating a surgical device on the sterile side of a sterile barrier, which may include 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, wherein the passive torque element is connected to the surgical device and rotates 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 rotating the passive torque element to move a seal about the catheter between an open position and a closed position.

[0016] This document also discloses embodiments of a method for performing neurovascular surgery, which may include providing a multi-catheter assembly including an access catheter, wherein the access catheter is connected to a first passive torque element located on the sterile side of a sterile barrier, a first active torque element is magnetically connected to the first passive torque element, and the access catheter is rotated by rotating the first active torque element. In some embodiments, the multi-catheter assembly may further include a guidewire connected to a second passive torque element, wherein the method may further include magnetically connecting the second active torque element to the second passive torque element and rotating the guidewire by rotating the second active torque element. In some embodiments, the first and second active torque elements may each be movably carried independently by a hub adapter. In some embodiments, the multi-catheter assembly may further include a guiding catheter and a surgical catheter. The surgical catheter may be an aspiration catheter, an embolization deployment catheter, a stent deployment catheter, a flow shunt deployment catheter, a diagnostic angiography catheter, a stent retrieval catheter, a clot retrieval device, a balloon catheter, a catheter facilitating percutaneous flap repair or replacement, or an ablation catheter.

[0017] This document also discloses embodiments of a robot drive system, which may include an active torque element configured on the non-sterile side of a sterile barrier and a passive torque element configured on the sterile side of the sterile barrier. The active torque element includes a plurality of magnets configured to rotate about a central axis, and the passive torque element includes a plurality of magnets configured to rotate about a central axis. Each of the plurality of magnets in the active torque element may be connected to one of the plurality of magnets in the active torque element, such that the plurality of magnets in the passive torque element rotate in response to rotation of the plurality of magnets in the active torque element. Some embodiments may include an intervention device connected to the passive torque element, such that the intervention device rotates in response to rotation of the plurality of magnets in the passive torque element. The intervention device may be configured to move axially along an axis transverse to the central axis of the plurality of magnets in the passive torque element. In some embodiments, the intervention device may be configured to move axially along an axis transverse to the central axis of the plurality of magnets in the passive torque element. The central axis of the plurality of magnets in the active torque element may be coaxial with the central axis of the plurality of magnets in the passive torque element. In some embodiments, the passive torque element may be connected to a hub. In some embodiments, the active torque element may be connected to a hub adapter.

[0018] This document also discloses embodiments of a method for rotating surgical instruments on the sterile side of a sterile barrier without allowing any power cables to pass through the sterile barrier. Furthermore, this document discloses embodiments of a method for rotating surgical instruments on the sterile side of a sterile barrier using a rotating hub without any power cables connected to the rotating hub.

[0019] This document also discloses embodiments of a hub assembly for a robotically driven interventional device, which may include an interventional device hub having an interventional device and at least one magnet. The hub assembly is configured to be located on the sterile side of a sterile area barrier and magnetically connected to a hub adapter on the non-sterile side of the sterile area barrier, such that the hub assembly moves axially in response to axial movement of the hub adapter, and at least one magnet of the hub assembly rotates 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 be operatively connected to the interventional device, such that rotation of at least one magnet of the hub assembly causes rotation of the interventional device. In some embodiments, at least one magnet is configured to rotate about an axis transverse to the axis of rotation of the interventional device. In some embodiments, at least one magnet of the hub assembly is configured to be connected to a valve of a fluidic subsystem of the hub assembly. In some embodiments, the valve is a hemostatic valve, wherein rotation of at least one magnet of the hub assembly is configured to cause the hemostatic valve to move between an open and closed configuration. In some embodiments, the valve is configured to selectively actuate fluid into or out of the interventional 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 agent. In some embodiments, at least one magnet comprises a polymagnet having multiple magnetic zones. 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 multiple magnets, wherein at least one magnet of the hub adapter comprises multiple magnets, and each of the multiple magnets of the hub assembly is configured to rotate in response to rotation of one of the multiple magnets of the hub adapter. In some embodiments, the multiple magnets of the hub assembly include a first magnet connected to an interventional device (such that rotation of the first magnet causes rotation of the interventional device) and a second magnet connected to a valve of the fluid dynamics subsystem. In some embodiments, the hub assembly includes one or more detectable objects configured to be detected by one or more sensors on the non-sterile side of a sterile area barrier. In some embodiments, the hub assembly includes a passive torque element comprising at least one magnet of the hub assembly and a magnet support, wherein at least one magnet of the hub assembly is attached to the magnet support, and wherein the passive torque element is configured to rotate in response to rotation of at least one magnet of the hub adapter. In some embodiments, the magnet support is formed of a ferrous material. In some embodiments, at least one magnet of the hub assembly and the magnet support are each disc-shaped. In some embodiments, the hub assembly includes a mounting member and an intervention hub detachably connected to the mounting member. In some embodiments, at least one magnet of the hub assembly is attached to the mounting member.In some embodiments, at least one magnet of the hub assembly is configured to rotate about an axis of rotation, wherein the hub assembly is configured to move axially along an axis transverse to the axis of rotation 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 space at least one magnet of the hub assembly from the drive surface.

[0020] This document also discloses embodiments of a robot drive system that may include a hub adapter located on the non-sterile side of a sterile area barrier and configured for axial movement. 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 area 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, wherein 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, wherein the third axis is parallel to the second axis. In some embodiments, the hub adapter is configured to move axially along a drive surface, and the hub adapter further includes a spring assembly comprising one or more springs configured to bias at least one magnet of the hub adapter to 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 a plurality of magnets, wherein at least one magnet of the hub assembly includes a plurality of magnets, and each of the plurality of magnets of the hub adapter is configured to rotate to cause rotation of one of the plurality of magnets of the hub assembly. In some embodiments, the hub adapter includes an active torque element comprising at least one magnet of the hub adapter and a magnet support, wherein at least one magnet of the hub adapter is attached to the magnet support, and wherein 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 of a ferrous material. In some embodiments, the magnet of the hub adapter and the magnet support are each disk-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 space at least one magnet of the hub adapter from the drive surface. In some embodiments, at least one magnet of the hub adapter is configured to rotate about an axis of rotation, wherein the hub adapter is configured to move axially along an axis transverse to the axis of rotation 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 connected to an interventional device of the hub assembly, such that rotation of the at least one magnet of the hub assembly causes rotation of the interventional device. In some embodiments, at least one magnet of the hub assembly is configured to be connected to a valve of a fluidic subsystem of the hub assembly. In some embodiments, the valve is a hemostatic valve, wherein rotation of the at least one magnet of the hub assembly is configured to cause the hemostatic valve to move between an open and closed configuration. In some embodiments, the valve is configured to selectively actuate fluid into or out of the interventional 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, wherein the hub adapter includes one or more sensors configured to detect one or more detectable objects. In some embodiments, the hub assembly includes a mounting member and an intervention device hub detachably connected to the mounting member.

[0021] This document also discloses embodiments of a robot drive system, which may include at least one magnet and a frame, said at least one magnet being located on the non-sterile side of a sterile area barrier. At least one magnet is connected to the frame. The frame is configured to move from a retracted position to an extended position, wherein one or more magnets are positioned closer to the sterile area 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, wherein the hub adapter is configured to move axially along a drive surface. In some embodiments, the hub adapter includes a spring assembly comprising one or more springs configured to bias at least one magnet to maintain an air gap between at least one magnet and the drive surface when the frame is in the extended position. In some embodiments, the hub adapter is configured to translate axially along a first axis, wherein the frame is configured to translate axially between a retracted position and an extended position 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, wherein the third axis is parallel to the 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 implementations, the support components include multiple rollers.

[0022] This document also discloses embodiments of a robot drive system that may include a torque transmission system. The torque transmission system may include an active torque element located on the non-sterile side of a sterile area barrier and a passive torque element located on the sterile side of the sterile area 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 connect to an interventional device. The active torque element is configured to rotate to apply torque to the passive torque element, causing rotation of both the passive torque element and the interventional device. In some embodiments, the robot drive system further includes a hub assembly configured to be located on the sterile side of the sterile area barrier, wherein the passive torque element is connected to the hub. In some embodiments, the passive torque element is configured to rotate about an axis of rotation perpendicular to the axis of rotation of the interventional device.

[0023] This document also discloses an embodiment of a method for rotating a surgical device on the sterile side of a sterile area barrier, which may include magnetically connecting an active torque element located on the non-sterile side of the sterile area barrier to a passive torque element located on the sterile side of the sterile area barrier (wherein the passive torque element is connected to the surgical device), and rotating the active torque element to rotate the passive torque element magnetically connected to the active torque element and the surgical device connected to the passive torque element.

[0024] This document also discloses an embodiment of a method for performing vascular surgery, which may include providing a multi-catheter assembly, magnetically connecting a first active torque element to a first passive torque element, and rotating an access catheter by rotating the first active torque element. The multi-catheter assembly includes an access catheter, wherein the access catheter is connected to the first passive torque element located on the sterile side of a sterile area barrier.

[0025] This document also discloses an embodiment of a method for performing vascular surgery, which may include magnetically connecting a hub assembly having an interventional device on the sterile side of a sterile area barrier to a hub adapter on the non-sterile side of the sterile area barrier, and rotating at least one magnet of the hub adapter to cause rotation of at least one magnet of the hub assembly. Attached Figure Description

[0026] Figure 1 This is a schematic perspective view of an interventional setup including an imaging system, a patient support table, and a robot-driven system, according to this disclosure.

[0027] Figure 2 It is a longitudinal cross-section showing the concentric relationship between a guidewire with two degrees of freedom, an entry catheter with three degrees of freedom, and a guiding catheter with one degree of freedom.

[0028] Figure 3A This is an exploded schematic diagram of the interventional device hub, which is separated from the support platform by a sterile barrier.

[0029] Figures 3B to 3F An optional sterile barrier in the form of a transport tray is shown, which has one or more storage channels for carrying interventional devices.

[0030] Figure 3G to Figure 3K An implementation scheme of an alternative sterile barrier with a raised driving surface is shown.

[0031] Figure 3L and Figure 3M Depicting what can be with Figure 3G to Figure 3K An example of a hub used in conjunction with a sterile barrier.

[0032] Figure 4It is a schematic elevation cross-section through a hub adapter with a drive magnet, which is separated from the intervention device hub and driven magnet by a sterile barrier.

[0033] Figure 5A and Figure 5B The three-intervention device and four-intervention device assemblies are schematically shown.

[0034] Figure 6 This is a perspective view of the support platform.

[0035] Figure 7 This is a close-up view of the motor drive end of the support platform.

[0036] Figure 8 It is the vertical cross-section that runs through the motor and belt drive assembly.

[0037] Figure 9 This is a close-up view of the pulley end of the support platform.

[0038] Figure 10 It is the vertical cross-section that runs through the pulley.

[0039] Figure 11 It is through, for example Figure 5A and Figure 5B The elevation cross-section of the distal portion of those conduits shown.

[0040] Figure 12A and Figure 12B A force sensor integrated into the sidewall of a catheter is shown schematically.

[0041] Figure 13A and Figure 13B A sensor for measuring the elastic force of the magnetic connection between the hub and the corresponding hub adapter is schematically shown.

[0042] Figure 14 A dual encoder torque sensor is schematically shown for use with the conduit of this disclosure.

[0043] Figure 15 A clot capture and visualization device that can be integrated into a hub and / or connected to a suction line is shown.

[0044] Figures 16A to 16C An exemplary control mechanism for manipulating interventional devices driven by a corresponding hub is shown.

[0045] Figure 17 A side elevation schematic view of an interventional device assembly for aortic access and neurointerventional procedures is shown.

[0046] Figures 18A to 18EAn example sequence of steps for introducing a catheter assembly configured to achieve access to the aorta and neurovascular sites is described.

[0047] Figure 19 An embodiment of the mechanical connection between the driving mechanism and the driven mechanism is schematically shown.

[0048] Figures 20A to 20C An example sequence of steps for pre-charging conduit components in a stacked configuration is described.

[0049] Figures 21A to 21B An example sequence of steps for pre-charging conduit components in a stacked configuration is described.

[0050] Figure 22 Describing for Figures 21A to 21B The example test system for the pre-charge process described in the document.

[0051] Figure 23A An example of a catheter assembly is shown.

[0052] Figure 23B An example of the conduit assembly after the pre-filling procedure is shown.

[0053] Figure 23C An example of a catheter assembly is shown after a pre-filling procedure that includes relative movement between adjacent catheters.

[0054] Figures 23D to 23F It shows Figures 23A to 23C Example catheter components.

[0055] Figure 24 A schematic diagram of the control system is shown.

[0056] Figure 25 This is a perspective view of a part of a robot drive system, showing the passive torque element of the torque transmission system connected to the hub and the active torque element of the torque transmission system connected to the hub adapter.

[0057] Figure 26 yes Figure 25 Exploded view of the active torque element and the passive torque element.

[0058] Figure 27 yes Figure 25 A perspective view of the passive torque element.

[0059] Figure 28 yes Figure 25 Second perspective view of the passive torque element.

[0060] Figure 29 yes Figure 25 Exploded view of the passive torque element.

[0061] Figure 30 yes Figure 25 The second exploded view of the passive torque element.

[0062] Figure 31 This is a perspective view of an implementation of a passive torque element connected to a rotary hemostatic valve.

[0063] Figure 32 yes Figure 31 Second perspective view of the passive torque element and hemostatic valve.

[0064] Figure 33 yes Figure 31 Exploded view of the passive torque element and hemostatic valve.

[0065] Figure 34 This is a perspective view of a part of a robot drive system, showing the passive torque element and the active torque element connected to the hub. Figure 35 yes Figure 34 A second perspective view of a part of the robot's control system.

[0066] Figure 36 This is a first perspective view of the implementation scheme of the active torque element.

[0067] Figure 37 yes Figure 36 Second perspective view of the active torque element.

[0068] Figure 38 yes Figure 36 An exploded perspective view of the implementation scheme of the active torque element.

[0069] Figure 39 yes Figure 36 Front view of the magnet of the active torque element.

[0070] Figure 40 yes Figure 39 Front view of the magnet.

[0071] Figure 41 It is the section AA along the line. Figure 40 A cross-sectional view of the magnet.

[0072] Figure 42A This is a side view of the implementation scheme of the torque transmission system.

[0073] Figure 42B yes Figure 42A A perspective view of the torque transmission system.

[0074] Figure 43A This is a perspective view of the implementation scheme of the torque transmission system.

[0075] Figure 43B yes Figure 43A A side view of the torque transmission system.

[0076] Figure 43C yes Figure 43A The first exploded view of the torque transmission system.

[0077] Figure 43D yes Figure 43A The second exploded view of the torque transmission system.

[0078] Figure 43E yes Figure 43A First perspective view of the disc-shaped main body of the active torque element of the torque transmission system.

[0079] Figure 43F yes Figure 43E The second perspective view of the disc-shaped main body.

[0080] Figure 43G yes Figure 43A A perspective view of multiple torque transmission systems.

[0081] Figure 43H It includes hubs, hub adapters, and Figure 43A A perspective view of a part of the robot drive system of the torque transmission system.

[0082] Figure 43I yes Figure 43H A second perspective view of a part of the robot's drive system.

[0083] Figure 43J yes Figure 43H A side view of a part of the robot's drive system.

[0084] Figure 43K yes Figure 43H A perspective view of the hub adapter.

[0085] Figure 43L yes Figure 43H A perspective view of the hub.

[0086] Figure 43M yes Figure 43H A perspective view of the hub adapter.

[0087] Figure 43N yes Figure 43H A perspective view of a portion of the hub.

[0088] Figure 430 yes Figure 43N A second perspective view of a portion of the hub.

[0089] Figure 43P yes Figure 43H A side view of a part of the robot's drive system.

[0090] Figure 44A This is a perspective view of a portion of an implementation scheme for a torque transmission system, showing the active torque element and the passive torque element.

[0091] Figure 44B yes Figure 44A A top view of an implementation scheme for an active torque transmission element.

[0092] Figure 44C yes Figure 44A A top view of the magnet of the active torque transmission element.

[0093] Figure 44D yes Figure 44A A side view of the magnet of the active torque transmission element.

[0094] Figure 45A This is a top perspective view of the active torque subsystem of the torque transmission system.

[0095] Figure 45B yes Figure 45A Bottom perspective view of the active torque subsystem.

[0096] Figure 45C This is a top perspective view of the passive torque subsystem of the torque transmission system.

[0097] Figure 45D yes Figure 45C Bottom perspective view of the passive torque subsystem.

[0098] Figure 45E yes Figure 45C Top perspective view of a part of the passive torque subsystem.

[0099] Figure 45F yes Figure 45C Top perspective view of a part of the passive torque subsystem.

[0100] Figure 45G yes Figure 45C Top perspective view of a part of the passive torque subsystem.

[0101] Figures 46A to 46C An example of a method for generating repulsive forces within a torque transmission system is described.

[0102] Figures 47A to 47C An example of a method for generating repulsive forces within a torque transmission system is described.

[0103] Figure 48A This is a perspective view of the hub assembly.

[0104] Figure 48B yes Figure 48A Bottom view of the hub assembly.

[0105] Figure 48C yes Figure 48A A top view of the internal structure of the hub assembly.

[0106] Figure 48D yes Figure 48A A perspective view of the mounting components of the hub assembly.

[0107] Figure 48E yes Figure 48A A perspective view of the internal components of the hub assembly.

[0108] Figure 48F yes Figure 48E A top view of the internal components of the hub.

[0109] Figure 48G yes Figure 48E Side view of the internal components of the hub.

[0110] Figure 48H yes Figure 48E A cross-sectional view of the internal components of the hub.

[0111] Figure 48I yes Figure 48E A perspective view of the internal components of the hub.

[0112] Figure 48J This is a schematic diagram of a fluid management system.

[0113] Figure 48K yes Figure 48D A top view of the fluid management system in the installation components.

[0114] Figure 49A This is a perspective view of the hub adapter.

[0115] Figure 49B yes Figure 49A Bottom view of the hub adapter.

[0116] Figure 49C yes Figure 49A Side view of the hub adapter.

[0117] Figure 49D It is in the unfolded state. Figure 49A Side view of the hub adapter.

[0118] Figure 49E It is in a retracted state. Figure 49A Side view of the hub adapter.

[0119] Figure 49F yes Figure 49A Top view of the hub adapter.

[0120] Figure 49G It has a non-planar driving surface Figure 49A Top view of the hub adapter.

[0121] Figure 50A This is the rear view of the hub assembly.

[0122] Figure 50B yes Figure 50A A schematic diagram of the fluid dynamics management system within the hub assembly.

[0123] Figures 51A to 51B It is a perspective view of multiple hub assemblies mounted on the drive unit.

[0124] Figures 51C to 51D This is a top view of multiple hub adapters aligned with their respective hub assemblies.

[0125] Figures 51E to 51G This is a side view of the hub adapter aligned with the hub assembly.

[0126] Figures 51H to 51I This is a schematic diagram of a hub adapter aligned with a hub assembly having a hard stop mechanism.

[0127] Figures 51J to 51K This is a schematic diagram of a hub adapter aligned with a hub assembly having a disposable position sensor.

[0128] Figure 52A This is a perspective view of a magnet.

[0129] Figure 52B This is a top view of two magnets.

[0130] Figure 52C This is a top view of the torque element subassembly.

[0131] Figures 53A to 53D yes Figure 52B A top view of the magnetic connection between magnets.

[0132] Figures 54A to 54E This is a top view of the torque element subassembly.

[0133] Figure 55A This is a schematic diagram of a part of a hub adapter.

[0134] Figure 55B It is possible to be with Figure 55A A schematic diagram of a movable component used in conjunction with a hub adapter. Detailed Implementation

[0135] In some embodiments, a system is provided for advancing a guide catheter from the femoral or radial artery into the opening of one of the major vessels at the top of the aortic arch, thereby achieving supra-aortic access. The surgeon can then take over the interventional device via a robotically placed guide catheter and advance it into the cerebrovascular system.

[0136] In some implementations, the system can be additionally configured to robotically achieve intracranial vascular access and perform thrombectomy or other neurovascular surgeries.

[0137] The drive unit can be located above or to the side of the patient and is configured to axially advance, retract, and in some cases rotate and / or laterally deflect two or three or more different (e.g., concentric or side-by-side oriented) intravascular devices.

[0138] The hub or hub assembly can move along a path along the surface of the drive stage to advance or retract the intervention device as desired. Each hub (or hub assembly) may also contain a mechanism for rotating or deflecting as desired and is connected to a fluid delivery tube (not shown) of a type conventionally attached to a conduit hub. Each hub (or hub assembly) may be in electrical communication with the electronic control system via hardwired connection, RF wireless connection, or a combination of both.

[0139] Each hub (or hub assembly) can move independently on the surface of a sterile area barrier membrane carried by a drive stage. Each hub (or hub assembly) can be releasably and magnetically attached to a unique drive trolley on the side of the sterile area barrier stage. The drive trolley may also be referred to as a hub adapter. The drive system can independently move each hub (or hub assembly) proximally or distally to the surface of the barrier to move the corresponding interventional device proximally or distally within the patient's vascular system.

[0140] The trolley or hub adapter magnetically connected to the hub on the drive stage to provide linear motion actuation can be generic. The functionality of the catheter / guidewire can be provided based on what is included in the hub and shaft design. This allows for flexible system configuration to perform a wide range of surgeries using a variety of interventional devices on the same drive stage. Furthermore, the interventional devices and methods disclosed herein can be readily adapted for use with a wide variety of other drive systems, such as any of a variety of robotic surgical drive systems.

[0141] Figure 1 This is a schematic perspective view of the interventional device 10 having a patient support table 12 for supporting the patient 14. An imaging system 16 may be provided together with a robotic interventional device drive system 18 according to this disclosure.

[0142] The drive system 18 may include a support platform 20 for supporting, for example, a guidewire hub 26, an access catheter hub 28, and a guide catheter hub 30. In the context of this document, the term "access" catheter can be any catheter having a lumen with at least one distally or laterally oriented distal opening, which can be used for aspirating thrombi, providing access for additional devices to pass through or advance along it, or injecting saline, contrast agents, or therapeutic agents.

[0143] Depending on the desired clinical procedure, more or fewer interventional device hubs may be provided. For example, in some embodiments, diagnostic angiography may be performed using only a guidewire hub 26 and an access catheter hub 28 for driving the guidewire and access catheter (in the form of a diagnostic angiography catheter). Multiple interventional devices 22 extend between the support platform 20 and the femoral access point 24 on the patient 14 (in the example shown). Depending on the desired procedure, access may be achieved percutaneously or by incision into any of a variety of arteries or veins, such as the femoral or radial artery. Although this article primarily discloses information in the context of neurovascular access and surgery, robotic-driven systems and associated interventional devices can be readily configured for a wide variety of additional medical interventions in peripheral and coronary and venous vascular systems, the gastrointestinal system, the lymphatic system, cerebrospinal fluid cavities or spaces (e.g., the spinal canal, ventricles, and subarachnoid space), pulmonary airways, treatment sites accessed via ureteral or urethral or fallopian tube navigation, or other hollow organs or structures in the body (e.g., in intracardiac or structural cardiac applications such as valve repair or replacement, or in any endovascular procedure).

[0144] Display 23 (e.g., for viewing fluoroscopic images, catheter data (e.g., fiber Bragg grating fiber sensor data or other force or shape sensing data) or other patient data) may be carried by support 20 and / or patient support 12. Alternatively, the physician input / output interface including display 23 may be located away from the patient, such as behind a radiation shield, in a different room from the patient, or in a different facility from the patient.

[0145] In the example shown, the guidewire hub 26 is supported by the support platform 20 and is movable along the platform to advance and exit the guidewire into and out of the patient 14. The access catheter hub 28 is also supported by the support platform 20 and is movable along the platform to advance and exit the access catheter into and out of the patient 14. The access catheter hub can also be configured to rotate the access catheter in response to rotation control operation, and can also be configured to laterally deflect the deflectable portion of the access catheter in response to deflection control operation.

[0146] Figure 2 It is a longitudinal cross-section schematically showing the kinematic relationship between a guidewire 27 with two degrees of freedom (axial and rotational), an inlet catheter 29 with three degrees of freedom (axial, rotational and lateral deflection), and a guide catheter 31 with one degree of freedom (axial).

[0147] refer to Figure 3AThe support platform 20 includes a drive mechanism, described in more detail below, to independently drive the guidewire hub 26, the access catheter hub 28, and the guide catheter hub 30. An anti-bending feature 34 may be provided in the proximal anti-bending region to resist bending of portions of the interventional device across the distance between the support platform 20 and the femoral artery entry point 24. The anti-bending feature 34 may include a plurality of concentric, retractable, axially extending, and foldable tubes through which the interventional device extends.

[0148] Alternatively, the proximal segment of one or more device shafts can be configured with enhanced stiffness to reduce buckling during compression. For example, the proximal reinforced segment may extend distally from the hub to a distance of at least about 5 cm or 10 cm, but typically not exceeding about 120 cm or 100 cm, to support the device between the hub and the entry point 24 on the patient. Reinforcement can be achieved by using metal or polymer tubing or by embedding at least one or more axially extending elements, such as long guide wires or strips, into the wall of the device shaft. In some embodiments, the extension elements may be hollow and prevent wear, buckling, or damage at the hub's inlet and outlet. In some embodiments, the hollow extension element may be a hollow and flexible cover attached to the hub. The hollow extension element (e.g., a hollow and flexible cover) may cover a portion of the device shaft as it passes through the hub. In some embodiments where the hollow extension element is a cover, the coating may be attached to a portion of the hub such that passing the catheter device through the hub 26, 28, or 30 also passes the catheter device through the cover. In some embodiments, the buckling resistance device can be mounted on or around the device shaft to avoid misalignment or insertion angle errors between hubs or between a hub and the insertion point. The buckling resistance device can be a laser-cut hyaluronic acid tube, a spring, a telescopic tube, a tensioned split tube, etc.

[0149] In some implementations, multiple deflection sensors can be placed along the length of the catheter to detect buckling. Buckling can be detected by sensing that the distal tip of the catheter or interventional device has not moved while the hub is advanced distally. In some implementations, buckling can be detected by sensing that an energy load has occurred between the catheter shafts (e.g., due to friction).

[0150] Alternatively, a thin, tubular reinforcing structure may be embedded in the device wall or extend to the outside of the device wall, such as a tubular polymer extrusion or a section of thiocyanate tube. Alternatively, a removable reinforcing spindle may be placed within the lumen of the proximal segment of the device and removed proximally after distal advancement toward the patient access position to prevent buckling of the proximal spindle during distal advancement of the hub. Alternatively, the proximal segment of one or more device spindles may be configured as a tubular thiocyanate tube, which may be machined (e.g., with a laser) such that its mechanical properties vary along its length. The proximal segment may be formed of stainless steel, nitinol, and / or cobalt-chromium alloys, optionally combined with a polymer component that provides lubrication and hydraulic sealing. In some embodiments, the proximal segment may be formed of a polymer, such as polyetheretherketone (PEEK). Alternatively, the wall thickness or diameter of the interventional device may be increased in the buckling-resistant region.

[0151] In some implementations, a device shaft with high stiffness (e.g., axial and torsional) 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 implementations may be advantageous for robot actuation in situations where tactile feedback to the user is not provided.

[0152] In some embodiments, a flexible covering layer may be applied to the device shaft and / or hub to reduce the friction between the device shaft and / or hub and the second device shaft when the second device shaft passes through the device shaft and / or hub with the second device shaft.

[0153] The interventional device hub can be separated from the support platform 20 by a sterile barrier 32, which may also be referred to as a sterile area barrier. The sterile barrier 32 may comprise a thin plastic film, such as polyethylene terephthalate (PET), polyethylene terephthalate glycol copolymer (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 platform 20 and the associated drive system to be located on the non-sterile (lower) side of the sterile barrier 32. The guidewire hub 26, the access catheter hub 28, the guide catheter hub 30, and the associated interventional device are all located on the sterile (upper) side of the sterile barrier 32. The sterile barrier is preferably waterproof and can also be used as a tray for use in the packaging of the interventional device, as will be discussed further below. The interventional device may be supplied individually or as a coaxial pre-assembled kit, which is transported and stored in a tray and packaged in sterile packaging.

[0154] Figures 3B to 3FAn optional sterile barrier and transport tray are schematically illustrated. The optional sterile barrier is in the form of a bifunctional sterile barrier placed on a support table during interventional procedures. The transport tray has one or more storage channels for carrying sterile interventional devices. The sterile barrier can also be used as a sterile working surface for the preparation of catheters or other devices during procedures.

[0155] refer to Figure 3B and Figure 3C A sterile barrier 32 in the form of a pre-formed tray is shown for mounting an elongated support platform 20. In use, the elongated support platform 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 hub of the interventional device. In one embodiment, in a linear drive configuration, the support surface 104 has an axial length greater than the intended length of the interventional device.

[0156] The length of the support surface 104 will typically be at least about 100 cm, and in the range of about 100 cm to about 2.7 m. Shorter lengths can be used in systems configured to advance the drive connector along an arcuate path. In some embodiments, two or more support surfaces may be used instead of a single support surface 104. The two or more support surfaces may have a combined length of about 100 cm to about 2.7 m. The width of the linear drive stage is preferably no more than about 30 cm and about 80 cm.

[0157] At least a first channel 106 may be provided, extending axially for at least a portion of the length of the support platform 20. In the illustrated embodiment, the first channel 106 extends along the entire length of the support platform 20. Preferably, the first channel 106 has sufficient length to accommodate interventional devices and sufficient width and depth to accommodate a corresponding hub (e.g., by providing lateral support to prevent hub displacement when forces are applied). The first channel 106 is defined within the base plate 108, the outer sidewall 110, and the inner sidewall 111, forming an upward-facing concave shape. Optionally, a second channel 112 may be provided. The second channel 112 may be located on the same side or opposite side of the upper support surface 104 as the first channel 106. Two, three, or more additional recesses (e.g., additional channels or holes) may be provided to accommodate additional medical devices or supplies useful during interventional procedures, as well as a wash basin for collecting fluids and serving as catheters and related devices.

[0158] refer to Figure 3DThe guide catheter hub 30 is shown positioned on the upper support surface 104 and magnetically connected to a corresponding connector housing a drive magnet, the connector being located below the sterile barrier 32. The entry catheter hub 28 and entry catheter 29, as well as the guidewire hub 26 and guidewire 27, are shown positioned within the first channel 106, for example, before introduction via the guide catheter 31 or after removal from the guide catheter 31.

[0159] The interventional device can be located within channel 106 and enclosed within a sterile barrier for transport. In a clinical location, the top panel of the sterile barrier can be removed, or the tubular sterile barrier package can be opened and axially removed from the support 20 and sterile barrier assembly 32, exposing the sterile top side of the sterile barrier tray and any included interventional device. The interventional device can be carried individually in the channel or pre-assembled into an access assembly or surgical assembly, which will be discussed in further detail below.

[0160] Figures 3D to 3F A support table with a sterile barrier in the appropriate location is shown, and... Figure 3E In this embodiment, an interventional device is configured in the access assembly for aortic access after the access assembly is connected to a corresponding trochle below a sterile barrier. The access assembly may be pre-assembled, with the guidewire fully advanced through the access catheter, which in turn is fully advanced through the guide catheter. In embodiments where the access catheter or other catheters are pre-formed (i.e., pre-bent or not straight), the guidewire and / or external catheter may be positioned such that the relatively rigid portion does not overlap with the more rigid, curved portion of the pre-formed catheter, for example, to avoid creep or straightening of the pre-formed catheter and / or introducing the bend into other straight catheters. The access assembly may be lifted out of channel 106 and positioned on support surface 104 for connection to a corresponding drive magnet and introduction into the patient. The guide catheter hub 30 is the most distal hub. The access catheter hub 28 is located proximally to the guide catheter hub, allowing the access catheter 29 to extend distally through the guide catheter. The guidewire hub 26 is located proximally to allow the guidewire 27 to advance through the access catheter 29 and the guide catheter 31.

[0161] Figure 3F The surgical assembly is shown after the surgical components have been introduced via a guiding catheter 31 for access over the aorta. In this embodiment, the guiding catheter 31 is held at the distal end of the interventional device. A first surgical catheter 120 and a corresponding hub 122 are shown extending through the guiding catheter 31. An optional second surgical catheter 124 and a corresponding hub 126 are shown extending through the first surgical catheter 120. A guidewire 27 extends through at least a portion of the second surgical catheter 124 in a quick-change version of the second surgical catheter 124, or through the entire length of the second surgical catheter 124 in an embodiment above a guide wire.

[0162] Such as combination Figure 17 In more detail, multiple catheter stacks can be used to achieve access and endovascular procedures without the need for catheter replacement. This can be performed in manual or robotically driven procedures. In one example, the guiding catheter 31 may include a catheter having an inner diameter of at least about 0.08 inches, and in one embodiment, about 0.088 inches. The first surgical catheter 120 may include a catheter having an inner diameter of about 0.065 inches to about 0.075 inches, and in one embodiment, catheter 120 has an inner diameter of about 0.071 inches. The second surgical catheter 124 may be an access catheter having an OD size that allows advance through the first surgical catheter 120. The second surgical catheter may be steerable and have a deflection control 2908 configured to laterally deflect the distal end of the catheter. The second surgical (access) catheter may also have a lumen sized to allow a properly sized guidewire to be held inside the second surgical catheter while contrast agent is injected through the second surgical catheter.

[0163] In some embodiments, catheter 31 may be a “large-bore” inlet or guide catheter having a diameter of at least about 0.075 inches or at least about 0.080 inches. Catheter 120 may be a suction catheter having a diameter of about 0.060 to about 0.075 inches. Catheter 124 may be a manipulable catheter with a deflectable distal tip having a diameter of about 0.025 inches to about 0.050 inches. Guidewire 27 may have a diameter of about 0.014 to about 0.020 inches. In one example, catheter 31 may have a diameter of about 0.088 inches, catheter 120 may have a diameter of about 0.071 inches, catheter 124 may have a diameter of about 0.035 inches, and guidewire 27 may have a diameter of about 0.018 inches.

[0164] In a commercial implementation, the pre-assembled access components (guiding catheter, access catheter, and guidewire) can be housed within a first channel on a sterile barrier tray, and the pre-assembled surgical components (one or two surgical catheters and a guidewire) can be housed within the same or different second channels on the sterile barrier tray. One or more additional catheters or interventional tools may also be provided, depending on potential needs during the interventional procedure.

[0165] Figure 3G to Figure 3K An embodiment of an alternative sterile barrier with a raised drive surface (e.g., a raised, arched road-like drive surface) is shown. Figure 3GThis is a cross-sectional view of a sterile barrier 232. The sterile barrier 232 includes a protruding upper support surface 204. Fluid channels 205 and 207 are located laterally to and below the support surface 204 for automatically removing or draining fluid from the support surface 204 (e.g., during interventional procedures). Fluid channels 205 and 207 may extend axially for at least a portion of the length of the sterile barrier.

[0166] Figure 3I , Figure 3J and Figure 3K A perspective view, a cross-sectional view, and a top cross-sectional view of the proximal end of the sterile barrier 232 are shown, respectively. Figures 3I to 3K As shown, the sterile barrier 232 may include a groove 240 communicating with fluid channels 205 and 207. The groove 240 may receive fluid from channels 205 and 207 (e.g., during interventional procedures). The groove 240 may be at least partially located below the fluid channels 205 and 207, allowing fluid within channels 205 and 207 to flow into the groove 240. In some embodiments, the fluid channels 205 and 207 may be at an angle relative to a horizontal plane (e.g., descending from the farthest end of the channel to the groove 240), guiding fluid within channels 205 and 207 into the groove 240. For example, the depth of channels 205 and 207 may increase from the farthest end of the channel to the groove 240. Alternatively, during part or all of the interventional procedure, the sterile barrier 232 and / or support platform can be positioned at an angle relative to the horizontal plane, such that the ends of channels 205 and 207 furthest from the groove 240 are positioned above the groove 240. For example, the sterile barrier 232 and / or support platform can be constructed or arranged at an angle such that the ends of the sterile barrier 232 and / or support platform opposite the groove 240 are positioned above the groove 240. Alternatively or additionally, the drive mechanism can temporarily tilt the sterile barrier 232 and / or support platform such that the ends of the sterile barrier 232 and / or support platform opposite the groove 240 are positioned above the groove 240 (e.g., by raising the ends of the sterile barrier and / or support platform opposite the groove 240, or lowering the ends of the sterile barrier 232 and / or support platform at the location of the groove 240), allowing fluid in channels 205 and 207 to flow into the groove 240.

[0167] The tank 240 may include a drain port 242. The tank 240 may be configured in a shape, size, and / or other manner as needed, such that fluid within the tank 240 is drained into the drain port 242. The drain port 242 may include a pipe, a barbed fitting, and / or a switching valve for removing fluid from the tank 240. Figures 3I to 3KAs shown, the groove 240 may be located at the proximal end of the sterile barrier 232. In an alternative embodiment, the groove 240 may be located at the distal end of the sterile barrier 232. In some embodiments, the sterile barrier 232 may include a first groove 240 at the proximal end and a second groove 240 at the distal end. In some embodiments, the groove 240 may also be used as a washing basin.

[0168] The first channel 206 may extend axially for at least a portion of the length of the sterile barrier 232. The channel 206 may have sufficient length to accommodate the interventional device and sufficient width and depth to accommodate the corresponding hub (e.g., by providing support to prevent the hub from dislodging when force is applied). Optionally, a second channel 212 may be provided. The second channel 212 may be located on the same side or opposite side of the upper support surface 204 as the first channel 206. Figure 3G Channel 212 is shown on the opposite side of channel 206 on support surface 204. Figure 3H This is a cross-sectional view showing an alternative embodiment of the sterile barrier 232, wherein channel 212 and channel 206 are on the same side of the support surface 204.

[0169] like Figure 3G and Figure 3H As shown, channels 206 and 212 can have generally triangular, wedge-shaped, or other angular cross-sections to accommodate the hub at an angle relative to the horizontal plane. Accommodating the hub at an angle relative to the horizontal plane allows for a smaller width of the sterile barrier 232.

[0170] Two, three or more additional recesses (e.g., additional channels or holes) may be provided to accommodate additional medical devices or supplies that may be useful during interventional procedures, as well as a wash basin for collecting fluids and serving as catheters and related devices.

[0171] In some embodiments, the sterile barrier 232 may include one or more structural ribs 236. The sterile barrier 232 may also include one or more frame support protrusions 228 and 238.

[0172] exist Figure 3G In the embodiment of the sterile barrier 232 shown, the width x1 can be 14 in, about 14 in, 12 to 16 in, 10 to 18 in, or any other suitable width. Figure 3HIn the embodiments of the sterile barrier 232 shown, the width x1 can be 15 in, about 15 in, 13 to 17 in, 11 to 19 in, or any other suitable width. The height y1 of the support surface 204 can be 0.125 in, about 0.125 in, 0.1 in to 0.15 in, or any other suitable height. In some embodiments, the support surface 204 may be recessed from the top surface 233 of the sterile barrier 232. The height y2 between the bottom and top surfaces 233 of the support surface 204 can be 0.5 in, about 0.5 in, 0.25 in to 0.75 in, 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 in, about 5 in, 4 in to 6 in, or any other suitable width. The width x3 of the support surface 204 can be 4 in, about 4 in, 3 in to 5 in, or any other suitable width. The height y3 of channel 206 and / or channel 212 can be 1.5 in, about 1.5 in, 1 in to 2 in, or any other suitable height. The width x4 of channel 206 and / or channel 212 can be 3 in, about 3 in, 2 in to 4 in, or any other suitable width. Channel 206 and / or channel 212 can be defined by an arc angle α of 90°, about 90°, 80° to 100°, or any other suitable angle, and a radius of curvature of 0.125 in, about 0.125 in, 0.1 in to 0.15 in, or any other suitable radius of curvature. In some embodiments, an arc angle α of 90° or about 90° can be used to accommodate a hub having a rectangular or generally rectangular cross-section. The support surface 204 can be defined by a radius of curvature of 13 in, about 13 in, 11 in to 15 in, or any other suitable radius of curvature. Channel 205 and / or channel 207 may be defined by a radius of curvature of 0.25 in, about 0.25 in, 0.15 in to 0.35 in, or any other suitable radius of curvature.

[0173] Figure 3L and Figure 3M Depicting what can be compared to Figure 3G to Figure 3KThe example dimensions of the hub 250 used in conjunction with the sterile barrier 232 are shown. The hub 250 can be any hub described herein. In some embodiments, the hub 250 can have a width w1 of 3.75 in, about 3.75 in, 3.25 in to 4.25 in, or any other suitable width. The hub 250 can have a height h1 of 1.5 in, about 1.5 in, 1.25 in to 1.75 in, or any other suitable height. Alternatively, the hub 250 can have a height h2 of 2 in, about 2 in, 1.75 in to 2.25 in, or any other suitable height. In some embodiments, the hub 250 can have a length L1 of 2.5 in, about 2.5 in, 2 in to 3 in, or any other suitable length. Alternatively, the hub 250 can have a length L2 of 4 in, about 4 in, 3.5 in to 4.75 in, or any other suitable length.

[0174] In some embodiments, the top surface of the support platform may include surface features that substantially correspond to the surface features of the sterile barrier 232. For example, the support platform may include raised surfaces and / or one or more recesses, the raised surfaces being configured to correspond to the shape, size, and location of the support surface 204, and the recesses being configured to correspond to the shape, size, and location of the channels 205 and 207.

[0175] In alternative embodiments, the planar support surface (e.g., support surface 104 of the sterile barrier 32) may be positioned at an angle relative to the horizontal plane to facilitate fluid drainage. In some embodiments, the sterile barrier and / or support table may be positioned at an angle relative to the horizontal plane during part or all of the interventional procedure to facilitate fluid drainage. For example, the sterile barrier and / or support table may be constructed or arranged at an angle (e.g., such that one lateral side of the planar support surface is higher than the other lateral side of the planar support surface, the proximal end is higher than the distal end, or the distal end is higher than the proximal end) to facilitate fluid drainage. Optionally or additionally, the drive mechanism may temporarily tilt the sterile barrier and / or support table (e.g., such that one lateral side of the planar support surface is higher than the other lateral side of the planar support surface, the proximal end is higher than the distal end, or the distal end is higher than the proximal end) to facilitate fluid drainage. For example, the drive mechanism can raise or lower a lateral side of the sterile barrier and / or support, the proximal end of the sterile barrier and / or support, and / or the distal end of the sterile barrier and / or support.

[0176] In some implementations, the support surface (e.g., support surface 104 of the sterile barrier 32) may be positioned in a vertical configuration, rather than, for example... Figures 3A to 3FThe horizontal configuration is shown. For example, the support surface 104 can be positioned at approximately 90 degrees (or any other suitable angle) relative to the horizontal plane (e.g., relative to...). Figures 3A to 3F The illustrated embodiment, around the long axis of the supporting surface 104 (e.g. Figure 3C The vertical configuration (shown as longitudinal axis A1) rotated 90 degrees) also provides easier interaction between the physician and the drive system 18. Furthermore, the vertical configuration allows for a lower axis closer to the patient's travel catheter without increasing the spacing height of the drive system 18.

[0177] In some embodiments, the drive system 18 may be positioned at an angle to the horizontal plane during part or all of the interventional procedure to facilitate fluid drainage. For example, the drive system 18 may be configured or arranged at an angle (e.g., such that one lateral side of the planar support surface is higher than the other lateral side of the planar support surface, the proximal end is higher than the distal end, or the distal end is higher than the proximal end) to facilitate fluid drainage. Alternatively or additionally, the drive mechanism may temporarily tilt the drive system 18 (e.g., such that one lateral side of the drive system 18 is higher than the other lateral side of the drive system 18, the proximal end is higher than the distal end, or the distal end is higher than the proximal end) to facilitate fluid drainage. For example, the drive mechanism may 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 may be angled such that it extends at an angle away from the pivot point 24 (e.g., such that the proximal end is higher than the distal end), for example, to allow space for the patient's feet.

[0178] refer to Figure 4 Hub 36 can represent any hub previously described. Hub 36 includes a housing 38 extending between a proximal end 40 and a distal end 42. An interventional device 44, which can be any interventional device disclosed herein, extends distally from hub 36 and enters patient 14 (not shown). Hub adapter 48 or trolley acts as a shuttle, propelled along a track proximally or distally in response to operator commands or controller operations. Hub adapter 48 includes at least one drive magnet 67 configured to connect with a driven magnet 69 carried by hub 36. This provides a magnetic connection between drive magnet 67 and driven magnet 69 via a sterile barrier, such that hub 36 moves on top of sterile barrier 32 in response to movement of hub adapter 48 outside the sterile area. Movement of hub adapter is driven by a drive system carried by a support platform, which is described in further detail below. Hub adapter can serve as a robotic actuator for an interventional device connected thereto.

[0179] To reduce friction in the system, hub 36 may be equipped 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 separate the sterile barrier from the surface of the driven magnet 69 by at least about 0.02 cm (about 0.008 inches), and typically not more than about 0.08 cm (about 0.03 inches). In some embodiments, the gap is in the range of about 0.03 cm (about 0.010 inches) to about 0.041 cm (about 0.016 inches). The gap between the driving magnet 67 and the driven magnet 69 typically does not exceed about 0.38 cm (about 0.15 inches), and in some embodiments does not exceed about 0.254 cm (about 0.10 inches), for example, in the range of about 0.216 cm (about 0.085 inches) to about 0.229 cm (about 0.090 inches). The hub adapter 48 may similarly be equipped with at least a first hub adapter roller 59 and a second hub adapter roller 63, which can be positioned relative to the corresponding first roller 53 and second roller 55, such as... Figure 4 As shown.

[0180] refer to Figure 6 An example of a low-profile linear drive support table 20 is schematically shown. The support table 20 includes an elongated frame 51 extending between a proximal end 52 and a distal end 54. At least one support table support 56 is provided to stabilize the support table 20 relative to a patient (not shown). The support 56 may include one or more legs, or preferably articulated arms, which are configured to allow the frame 51 to move and be positioned above or near the patient.

[0181] Figure 7 An example of the linear drive stage 20 shown includes three different drives. However, depending on the desired clinical performance, it may include two drives or four or more drives (e.g., up to eight drives). A first drive pulley 58 engages with a first drive belt 60. A first trolley support 61 is fixed to the first drive belt 60 such that rotation of the first drive pulley 58 causes the first drive belt 60 to rotate through an elongated closed-loop path. Depending on the direction of rotation of the drive pulley 58, the first trolley support 61 may be positioned along the longitudinal axis of the support stage 20 (e.g., Figure 7 The longitudinal axis A2 shown advances in the proximal or distal direction. In the illustrated embodiment, the drive pulley 58 is equipped with surface structures, such as a plurality of drive pulley teeth 62, for engaging with complementary teeth on the first drive belt 60.

[0182] A second drive pulley 64 may engage a second drive belt 66, which is configured to axially move a second trolley bracket 68 along an axial path on the support platform 20. A third drive pulley 70 may be configured to drive a third drive belt 72 to advance a third trolley bracket 73 axially along the support platform 20. Each trolley bracket may be equipped with the previously discussed but not described... Figure 7 The drive magnet assembly shown forms a connector for magnetically connecting to a corresponding driven magnet within the hub of the intervention device, as already discussed.

[0183] Figure 8 A schematic detailed view of the drive system is shown. Drive support 74 can be carried by frame 51 for supporting the drive assembly. Second drive pulley 64 is shown in the elevation cross-section as being driven by motor 75 via rotatable shaft 76. Rotatable shaft 76 can be rotatably carried by support 74 via first bearing 78, shaft connection 80, and second bearing 79. Motor 75 can be stabilized by motor bracket 82 connected to drive support 74 and / or frame 51. Belt drive assemblies for first drive belt 60 and third drive belt 72 can be similarly constructed and will not be described in detail herein. In some embodiments, the drive system described herein can be a collapsible rack and pinion drive system. In such embodiments, motor 75 can be attached to and move with a trolley.

[0184] refer to Figure 9 and Figure 10 Each of the first, second, and third drive belts extends around a corresponding first idler pulley 84, second idler pulley 86, and third idler pulley 88. Each idler pulley may be equipped with a corresponding tension bracket 90, which is configured to adjust the idler pulley in a proximal or distal direction to adjust the tension of the corresponding belt. Therefore, each tension bracket 90 is equipped with a tension adjusting element 92, such as a rotatable screw.

[0185] like Figure 10 As shown, for example, the second idler wheel 86 can be carried by a rotatable shaft 94, which is rotatably fixed relative to the mounting bracket by a first bearing 96 and a second bearing 98.

[0186] Any catheter (e.g., Figure 5A , Figure 5B or Figure 11 (As shown) It typically comprises an elongated tubular body extending between a proximal end and a distal functional end. The length and diameter of the tubular body depend on the desired application. For example, lengths of approximately 90 cm to approximately 195 cm or longer are commonly used for femoral access percutaneous transluminal coronary artery applications. Intracranial or other applications may require different catheter shaft lengths depending on the site of vascular access.

[0187] Any catheter disclosed herein can be equipped with a tilted distal tip. Reference Figure 11 The distal catheter tip 1150 includes a tubular body 1152, which includes an advance section 1154, a marking band 1156, and a proximal section 1158. An inner tubular liner 1160 may extend throughout the entire length of the distal catheter tip 1150 and may include impregnated or extruded PTFE or other lubricating materials.

[0188] A reinforcing element 1162 (e.g., braid and / or spring coil) is embedded in an outer sheath 1164 that can extend the entire length of the catheter.

[0189] The advance section 1154 terminates distally at an inclined surface 1166 to provide an anterior sidewall portion 1168, which has a length measured between the distal end 130 of the marking band 1156 and the distal tip 1172. In some embodiments, the entire distal tip may have a shape to prevent the tip from getting stuck in the arterial bifurcation region. The posterior sidewall portion 1174 of the advance section 1154, in the illustrated embodiment, has an axial length approximately equal to the axial length of the anterior sidewall portion 1168, which is measured from approximately 180 degrees around the catheter. The axial length of the anterior sidewall portion 1168 can be from about 0.1 mm to about 5 mm, and is typically from about 1 mm to 3 mm. The rear sidewall portion 1174 may be equal to or at least shorter than the axial length of the front sidewall portion 1168 by about 0.1 mm, 0.5 mm, 1 mm, 2 mm, or less, depending on the desired performance.

[0190] Inclined surface 1166 and the longitudinal axis of the conduit (in) Figure 11 (represented by A3) is inclined at an angle A of approximately 45 degrees to approximately 80 degrees. In some embodiments, the angle is relative to the longitudinal axis of the conduit (e.g., ...). Figure 11 The longitudinal axis A3 shown is approximately 55 degrees to approximately 65 degrees. In one embodiment, angle A is approximately 60 degrees. One result of an angle A less than 90 degrees is the elongation of the long axis of the region at the distal port, which increases the surface area of ​​the port and can enhance clot suction or retention. Compared to the surface area of ​​a circular port (angle A is 90 degrees), the area of ​​an inclined port is typically at least approximately 105% and no more than approximately 130%, in some embodiments approximately 110% to approximately 125%, and in one example approximately 115% of the area of ​​the corresponding circular port (angle A is 90 degrees).

[0191] In the illustrated embodiment, the axial length of the advancement section remains constant around the circumference of the catheter, such that the inclined surface 1166 is substantially parallel to the distal surface 1176 of the marking band 1156. The marking band 1156 has a proximal surface substantially transverse to the longitudinal axis of the catheter, resulting in an internal elevation view of the marking band 1156 with a right-angled trapezoidal configuration. The short sidewall 1178 is rotated-aligned with the posterior sidewall portion 1174 and has an axial length of about 0.2 mm to about 4 mm, and typically about 0.5 mm to about 2 mm. The opposing long sidewall 1180 is rotated-aligned with the anterior sidewall portion 1168. The long sidewall 1180 of the marking band 1156 is typically at least about 10% or 20% longer than the short sidewall 1178, and may be at least about 50% or 70% or 90% longer than the short sidewall 1178, depending on the desired performance. Typically, the long sidewall 1180 will have a length of at least about 0.5 mm or 1 mm and less than about 5 mm or 4 mm.

[0192] The marking strip can be a continuous annular structure, or it can have at least one and optionally two, three, or more axially extending slits running its entire length. The slits can be located on or between the short sidewall 1178 or the long sidewall 1180, depending on the desired bending characteristics. The marking strip can comprise any of a variety of radiopaque materials, such as a platinum / iridium alloy, and its wall thickness is preferably no more than about 0.003 inches, and in one embodiment about 0.001 inches.

[0193] When using multiple catheters, the perceptual appearance of the marking strips can be unique or different for each catheter size or type, allowing the marking strips to be distinguished from each other by software algorithms. Distinguishing the marking strips of multiple catheters can be advantageous when using multiple catheters together, such as in a multi-catheter assembly or stack as described herein. In some embodiments, the catheter marking strips can be configured to enable software algorithms to detect movement at the catheter tip.

[0194] The marking zone of the assembled catheter can have relatively high flexural stiffness and high crushing strength, for example, at least about 50% or at least about 100% smaller than the proximal section 1158, but typically no more than about 200% smaller than the proximal section 1158. High crushing strength can provide radial support for the adjacent advancement section 1154, and particularly for the anterior sidewall portion 1168, so that the distal tip 1172 functions as a damage-free buffer during transluminal advancement and prevents collapse under vacuum. The proximal section 1158 preferably has lower flexural stiffness than the marking zone, and the advancement section 1154 preferably has even lower flexural stiffness and crushing strength than the proximal section 1158.

[0195] The propulsion section 1154 may include an outer tubular sheath 1164 and an optional inner liner 1160 distal extension, without other internal support structures at the distal end of the unmarked band 1156. The outer sheath 1164 may include extruded polyurethane, such as Tecothane®. The propulsion section 1154 may have no more than about 50% of the bending stiffness and radial crushing stiffness, and in some embodiments, no more than about 25%, 15%, or 5% or less of the corresponding values ​​of the proximal section 1158.

[0196] The catheter may also include axial tension elements or supports, such as bands or one or more filaments or fibers, to increase tension resistance and / or influence tortuosity in the distal region. Tension supports may include one or more axially extending monofilaments or multifilaments. One or more tension elements 1182 may be axially positioned within the catheter wall near the distal end of the catheter. One or more tension elements 1182 may function as tension supports and prevent the catheter tip from disengaging or elongating in a tensioned state (e.g., when the catheter retracts proximally through a kinked external catheter or a tortuous or narrowed vascular system).

[0197] At least one of the one or more tension elements 1182 may extend proximally along the length of the catheter wall from about 1.0 cm toward the distal end of the catheter to less than about 10 cm toward the distal end of the catheter, less than about 20 cm toward the distal end of the catheter, less than about 30 cm toward the distal end of the catheter, less than about 40 cm toward the distal end of the catheter, or less than about 50 cm toward the distal end of the catheter.

[0198] One or more tension elements 1182 may have a length greater than or equal to about 40 cm, greater than or equal to about 30 cm, greater than or equal to about 20 cm, greater than or equal to about 10 cm, or greater than or equal to about 5 cm.

[0199] At least one of the tension elements 1182 can extend the catheter length by at least approximately 50 cm, extend the catheter length by at least approximately 40 cm, extend the catheter length by at least approximately 30 cm, 20 cm, or 10 cm.

[0200] In some embodiments, the tension element extends proximally along the length of the coil 24 from the distal end of the conduit and terminates proximally on both sides at a transition of approximately 5 cm or 2 cm or less between the distal coil and the proximal braid. The tension element may terminate at the transition without overlapping the braid.

[0201] One or more tension elements 1182 may be placed near the liner 1160 or radially positioned outside the liner 1160. One or more tension elements 1182 may be placed near the braid and / or coil or radially positioned inside the braid and / or coil. One or more tension elements 1182 may be carried between the liner 1160 and the helical coil and may be secured to the liner or other underlying surface by adhesive before the addition of the next adjacent outer layer (e.g., coil). Preferably, the tension elements 1182 are secured to the marking tape 1156, for example, by adhesive or by mechanical interference. In one embodiment, the tension elements 1182 extend distally beyond the marking tape on a first (e.g., inner) surface of the marking tape, then wrap around the distal end of the marking tape, and extend along a second (e.g., outer) surface in one or both directions of proximal oblique or circumferential to completely wrap around the marking tape.

[0202] When one or more tension elements 1182 or filament bundles are circumferentially spaced within the catheter wall, the tension elements 1182 can be positioned radially symmetrically. For example, the angle between two tension elements 1182 relative to the radial center of the catheter can be approximately 180 degrees. Alternatively, depending on desired clinical performance (e.g., flexibility, trackability), the tension elements 1182 can be positioned radially asymmetrically. The angle between any two tension elements 1182 relative to the radial center of the catheter can be less than approximately 180 degrees, less than or equal to approximately 165 degrees, less than or equal to approximately 135 degrees, less than or equal to approximately 120 degrees, less than or equal to approximately 90 degrees, less than or equal to approximately 45 degrees, or less than or equal to approximately 15 degrees.

[0203] One or more tension elements 1182 may comprise materials such as Vectran®, Kevlar®, Polyester®, Spectra®, Dyneema®, Meta-Para-Aramide®, or any combination thereof. At least one of the one or more tension elements 1182 may comprise a single fiber or a bundle of multiple fibers, and the fiber or bundle may have a circular or rectangular (e.g., ribbon) cross-section. The term fiber or filament does not express composition, and they may comprise any of a variety of high tensile strength polymers, metals, or alloys, depending on design considerations such as the desired tensile failure limit and wall thickness. The cross-sectional dimension of one or more tension elements 1182, measured radially, may not exceed about 2%, 5%, 8%, 15%, or 20% of the cross-sectional dimension of the conduit 10.

[0204] The cross-sectional dimensions of one or more tension elements 1182, measured in the radial direction, may not exceed about 0.03 mm (about 0.001 inch), about 0.0508 mm (about 0.002 inch), about 0.1 mm (about 0.004 inch), about 0.15 mm (about 0.006 inch), about 0.2 mm (about 0.008 inch), or about 0.38 mm (about 0.015 inch).

[0205] One or more tension elements 1182 can increase the tensile strength of the distal region of the catheter to at least about 1 pound, at least about 2 pounds, at least about 3 pounds, at least about 4 pounds, at least about 5 pounds, at least about 6 pounds, at least about 7 pounds, at least about 8 pounds, or at least about 10 pounds or more before failing under tension (e.g., the marker strip detaches).

[0206] Depending on the desired data, any of a variety of sensors can be provided on any of the catheter, hub, trolley, or stage. For example, in some embodiments, it may be necessary to measure, for example, the axial tension or compressive force applied to the catheter along the force-sensing region. The distal end of the catheter will be manufactured to have, for example, Figure 11 A similar structure is shown, but with a helical coil distal portion. However, unlike a single helical coil using nitinol wire, the first conductor 140 and the second conductor 142 are wound into an intertwined helical coil and are electrically insulated from each other, for example, by a plastic / resin tubular body. See also Figure 12A Each coil communicates with the near-end hub via a single electrical conductor (e.g., a conductive line of a wire or a near-end extension).

[0207] This double-isolated spiral coil structure creates a capacitor. This is roughly equivalent to two NiTiN plates with a plastic layer between them, such as... Figure 12B As shown. Capacitance is inversely proportional to the distance between the wires. The only variable that will change is d, the distance between the plates. If an axial compressive force is applied to the conduit, the wires (e.g., conductors 140 and 142) will move closer together, thus increasing the capacitance. If an axial tensile force is applied, the wires will be further separated, decreasing the capacitance. This capacitance can be measured at the proximal end of the conduit, thus giving a measurement of the force at the helical capacitor. Although called a capacitor, this sensor measures the electrical interaction between the coils of the two wires. Due to the applied axial force, there may be a measurable change in inductance or other resulting changes.

[0208] At least the first spiral capacitor may have at least one, five, ten or more complete turns for each wire. The capacitor may be located within 5 cm, 10 cm or 20 cm of the distal end of the catheter body to sense the force experienced at the distal end. At least one second capacitor may be provided within 5 cm, 10 cm or 20 cm of the proximal end of the catheter body to sense the force experienced at the proximal end of the catheter.

[0209] It might also be desirable to use the inherent elasticity (compliance) of the magnetic connection to measure the elastic force of the magnetic connection spanning the hub and the corresponding carriage, in order to measure the force applied to the hub. The magnetic connection between the hub and carriage creates a spring. When a force is applied to the hub, the hub will move slightly relative to the carriage. See also Figure 13A In robotics, this is known as a series elastic actuator. This property can be used to measure the force applied from the trolley to the hub. To measure the force, the relative distance between the hub and the trolley is determined. Figure 13A The figure shows dx), and characterizes some effective spring constant k between the two components. See also Figure 13B .

[0210] Relative distances can be measured in several different ways. One method for measuring the relative distance between a hub and a carriage is using a magnetic sensor (e.g., a Hall effect sensor between the hub and carriage). A magnet is mounted to the hub or 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 other types of magnetic field sensors. Typically, multiple sensors can be used to increase the reliability of the measurement. This reduces noise and interference from external magnetic fields.

[0211] Other non-contact distance sensors can also be used. These sensors include optical sensors, inductive sensors, and capacitive sensors. Optical sensors will preferably be configured in a way that avoids the accumulation of blood or other fluids at the interface between the hub and the carriage. In some embodiments, for example, wireless (i.e., inductive) power can be used to convert movement and / or transmit information across a sterile barrier between the drive carriage and the hub.

[0212] The magnetic connection between the hub and the trolley has a shear or axial breakage threshold, which can be approximately 300 grams, 1000 grams, or greater. The processor can be configured to compare the axial force applied to the catheter with a preset axial trigger force, which, if applied to the catheter, is perceived as posing a risk to the patient. If the trigger force is reached, the processor can be configured to generate a response to the physician (e.g., visual, auditory, or tactile feedback), and / or intervene and stop further advancement of the catheter until repositioning is complete. Over-control functionality can be provided, allowing the physician to choose to continue advancing the catheter with a force exceeding the trigger force if they deem it justifiable to increase the force.

[0213] Force and / or torque sensing fibers (e.g., fiber Bragg grating (FBG) sensors) can be embedded in the catheter sidewall to measure force and / or torque at different locations along the catheter axis, or optionally integrated into the guidewire. The fiber measures axial strain, which can be converted into axial force or torque (when helically wound). At least a first FBG sensor can be integrated into the distal sensing region, proximal sensing region, and / or intermediate sensing region on the catheter or guidewire to measure force and / or torque near the sensor.

[0214] It may also be desirable to understand the three-dimensional configuration of the catheter or guidewire during and / or after transvascular placement. Shape-sensing fibers, such as arrays of FBG fibers, are used to sense the shape of the catheter and guidewire. By using multiple force-sensing fibers spaced at known distances from each other, the shape along the length of the catheter / guidewire can be determined.

[0215] Resistance strain gauges can be integrated into the body of a catheter or guidewire to measure force or torque, for example, at the distal tip and / or proximal end of the device.

[0216] Measurements of the force and / or torque applied to the catheter or guidewire shaft can be used to determine the applied force and / or torque exceeding a safety threshold. When the applied force and / or torque exceeds the safety threshold, a warning can be issued to the user. Measurements of the applied force and / or torque can also be used to provide feedback related to better catheter manipulation and control. Measurements of the applied force and / or torque can also be used in conjunction with processed fluoroscopic imaging information to determine or characterize distal tip movement.

[0217] 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 measure the position of the hub directly through a sterile barrier. A similar sensor can also be configured to measure the position of the trolley. Each hub can have at least one magnet attached to it. The robotic stage will have a linear array of corresponding magnetic sensors traversing the entire length of the stage. The processor can be configured to determine the position of the magnet along the length of the linear sensor array and display the axial position information to the physician.

[0218] Alternatively, the above objective can be achieved by using non-contact sensing sensors to directly measure the position of the hubs through a sterile barrier. Each hub or trolley can be equipped with a sensing "target." The robotic stage can be equipped with a sensing array along the entire working length of the stage. Alternatively, an absolute linear encoder can be used to directly measure the linear position of the hubs or trolleys. The encoder can use any of a variety of different technologies, including optical, magnetic, inductive, and capacitive methods.

[0219] In one implementation, a passive (non-electrically connected) target coil may be carried by each hub. A linear printed circuit board (PCB) can operate along the entire working length of the worktable (e.g., at least about 1.5 meters to about 1.9 meters), the PCB being configured to verify an interrogator signal that triggers a return signal from the passive coil. The PCB is configured to identify the return signal and its location.

[0220] The axial position of the trolley can be determined using a multi-turn rotary encoder to measure the rotational position of the pulley, which is directly related to the linear position of the trolley. Alternatively, the direct measurement of the trolley position can be accomplished by recording the number of steps that command a stepper motor to measure the rotational position of the pulley, which is directly related to the linear position of the trolley.

[0221] The position of the catheter and guidewire within the 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 its absence, with commanded or actual proximal catheter or guidewire movement at the hub can be used to detect loss of relative motion, which can indicate device axis buckling, prolapse, kinking, or similar outcomes (e.g., device axis length along the body interior (e.g., in the aorta) or between hubs on the body exterior). Processing can be performed in real time to provide position / orientation data up to 30 Hz, although this technique only provides data when fluoroscopic imaging is open. In some implementations, machine vision algorithms can be used to generate and suggest optimal catheter maneuvers to approach or reach anatomical landmarks, similar to driver assistance. Machine vision algorithms can utilize data to automatically drive the catheter based on the anatomy presented by fluoroscopic examination.

[0222] A dual-encoder torque sensor can be used to determine the proximal torque applied to the catheter or guidewire shaft. (Reference) Figure 14 The first encoder 144 and the second encoder 146 are axially spaced along the shaft 148 and are used to measure the angular difference along the length of the flexible conduit / tube. Since the conduit / tube has a known torsional stiffness, the angular difference is interpolated to torque. When torque is applied to the shaft, the slightly flexible portion of the shaft will twist. The difference between the angles measured by the encoder (dθ) tells us the torque. T = k dθ, where k is the torsional stiffness.

[0223] Confirming the absence of air bubbles in the fluid line can also be accomplished using a bubble sensor, especially when the physician is far from the patient. This can be done using a non-contact ultrasonic sensor that measures the intensity and Doppler frequency shift of reflected ultrasound waves passing through the sidewalls of the fluid conduit to detect bubbles and measure fluid velocity or level. The ultrasonic or optical sensor can be located near the inlet fluid flow path within the hub or in the supply line leading to the hub. To detect the presence of air bubbles in the infusion line (formed from an ultrasonic or optically transmissive material), the sensor can include a signal source on a first side of the flow path and a receiver on a second side of the flow path to detect bubbles by measuring the transmission of liquid through the tube. Alternatively, due to the relatively high echogenicity of bubbles, reflected ultrasonic signals can be detected from the same side of the flow path as the source.

[0224] Preferably, the bubble removal system is automatically activated upon detection of bubbles in the line. The processor can be configured to activate a valve in the flow path downstream of the bubble detector upon detection of a bubble. The valve diverts a stream of fluid from the flow path to the patient and into a reservoir. When no more bubbles are detected in the flow path, and after the fluid volume 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 may 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 upon detection of a bubble to reverse the fluid flow and remove the bubbles into a waste reservoir before re-establishing a bubble-free forward flow.

[0225] Furthermore, it is desirable for physicians to be able to observe the aspirated clot at a location within a sterile area, preferably as close to the patient as possible for fluid management purposes. This can be accomplished by providing a clot retrieval device mounted on the hub, or by providing a clot retrieval device mounted in the suction line away from the hub in the direction of the pump. (Reference) Figure 15 An example of the clot retrieval device 370 may include a body 380 that encloses a chamber 381 communicating with a first port 310 and a second port 320.

[0226] In some embodiments, body 380 includes a housing having a top portion 382 and a bottom portion 384. Body 380 may include a filter 330 located between the top portion 382 and the bottom portion 384 in chamber 381. In some examples, a first port 310 is configured to connect to a first end of a first tube 340, which is fluidly connected to the proximal end of a suction catheter.

[0227] In an embodiment configured for downstream connection from the hub, the first tube 340 includes a connector 342 located at a second end of the first tube 340, the connector 342 being configured to engage or mate with a corresponding connector on the hub, or to engage or mate with a corresponding connector communicating with the hub. A first port 310 communicates directly with a chamber upstream (e.g., top side) of the filter, and a second port 320 communicates directly with a chamber downstream (e.g., bottom side) of the filter to facilitate direct visualization of material captured on the upstream side of the filter.

[0228] In embodiments configured for remote operation, any of a variety of sensors may be provided to detect clumps passing through the suction line and / or trapped in the filter, such as optical sensors, pressure sensors, flow rate sensors, ultrasonic sensors, or other sensors known in the art.

[0229] In some embodiments, the second port 320 is configured to connect to a first end of a second tube 350, which is in fluid connection to a suction source (e.g., a pump). In some embodiments, the second tube 350 includes a connector 352 located at a second end of the second tube 350, the connector 352 being configured to engage or mate with a corresponding connector on the pump.

[0230] In some examples, system 300 may include a switching valve 360, such as a clamp 360. The clamp 360 may be located between filter 330 and the patient, for example on the first tube 340, to allow the user to engage the clamp and provide flow control by isolating the patient from the clot removal device 370. Closing valve 360 ​​and operating a remote vacuum pump (not shown) causes the canister associated with the vacuum pump and chamber 381 to reach the same low pressure. Due to the short distance and small linear volume of the lumen between chamber 381 and the distal end of the catheter, a sharp negative pressure spike is rapidly experienced at the distal end of the catheter after opening valve 360. Additional details are disclosed in U.S. Patent No. 11,259,821, entitled “Aspiration System with Accelerated Response,” issued March 1, 2022, to Buck et al., the entire contents of which are expressly incorporated herein by reference. In some embodiments, the vacuum may be circulated to the clot to recover the clot. The vacuum may be automatically and robotically controlled to remove the clot.

[0231] The body 380 may have a top surface spaced apart from the bottom surface by tubular sidewalls. In the illustrated embodiment, the top and bottom surfaces are substantially circular and spaced apart by cylindrical sidewalls. The top surface may have a diameter at least three times, or five times or more, than the axial length of the sidewalls (transverse to the top and bottom surfaces) to create a generally disc-shaped housing. Preferably, at least a portion of the top wall is optically transparent to improve clot visualization after clots have been captured in the clot recovery device 370. Additional details can be found in U.S. Patent Application No. 63 / 256,743, the entire contents of which are expressly incorporated herein by reference.

[0232] In some examples, body 380 may include a flushing port (not shown) configured to allow the injection of an optically transparent medium, such as air, brine, or other fluid, into chamber 381 to clear the optical path between the window and the filter, thereby improving clot visualization when clots become trapped in filter 330.

[0233] The foregoing describes certain specific implementations of the drive stage and associated components and catheters. A wide variety of different drive stage structures can be fabricated to support and axially advance and retract two, three, four, or more drive magnet assemblies for robotically manipulating drive interventional devices, fluid elements, and electrical umbilical elements for transmitting electrical signals and fluid to the catheter hub, as will be understood by those skilled in the art in light of the disclosure herein. Additional details can be found in U.S. Patent Application No. 17 / 527,393, the entire contents of which are expressly incorporated herein by reference.

[0234] While robot-operated and manually operated interventional devices have been described above, the device may be manually operated, robot-operated, or a combination of manually and robot-operated interventional devices, as those skilled in the art will understand in light of the disclosure herein.

[0235] Figures 16A to 16C An example control mechanism 2200 for manipulating interventional devices driven (or otherwise associated with) respective hubs is shown. For example, each hub can be manipulated and / or otherwise moved using at least one control element mounted in the control mechanism 2200. Each control element may be adapted to move a unique hub-associated interventional device during the interventional procedure.

[0236] like Figure 16AAs shown, the control mechanism 2200 includes a first control element 2202, a second control element 2204, a third control element 2206, and a fourth control element 2208. Depending on the intended intervention device configuration, more or fewer controls may be provided. Each control element 2202-2208 is movably supported on a shaft 2210 connected to a distal support 2212 and a proximal support 2214. Control elements 2202-2208 can be advanced distally or retracted proximally on the shaft 2210, as indicated by arrows 2218 and 2216. Furthermore, each control element 2202-2208 can also rotate about the shaft 2210, as indicated by arrow 2220. Movement of each control element can trigger a responsive movement in a corresponding trolley on the support platform, which in turn can drive movement of the corresponding hub, as already discussed.

[0237] The control unit 2200 may be located on or near a patient support table having a set of hubs and catheter / interventional devices. In some embodiments, the control unit 2200 may be located remotely from the support table, such as behind a radiation shield or in a different room or geographical location in a telemedicine embodiment.

[0238] Each control element 2202-2208 may correspond to and drive the hub and / or a combination of hub and intervention device. For example, control element 2202 may be configured to drive hub 30 ( Figure 3F The control 2204 can be configured to drive hub 28 (122) to move an interventional device, such as a 0.088-inch guide catheter corresponding to hub 30. Similarly, control 2204 can be configured to drive hub 28 (122) to move an interventional device, such as a 0.071-inch surgical catheter. Control 2206 can be configured to drive hub 126 to move an interventional device, such as a steerable access catheter. Control 2208 can be configured to drive hub 26 to move an interventional device, such as a guidewire, axially and rotationally.

[0239] Figure 16B An example of a control element 2202 on a manually operated control mechanism 2200 is shown. In operation, if the user 2230 moves the control element 2202 axially and distally along axis 2210, as indicated by arrow 2232, the corresponding connected hub and / or interventional device can responsively move in the same direction by the same or proportional amount. If the user 2230 rotates the control element 2202 about axis 2210 and advances the control element proximally, as indicated by arrow 2234, the corresponding connected interventional device will correspondingly rotate and move proximally by the same or proportional amount. If the user 2230 rotates the control element 2202 about axis 2210, as indicated by arrows 2236 or 2238, the corresponding connected hub will rotate and drive the corresponding interventional device in the same direction and / or by the same or proportional amount.

[0240] Other axes and degrees of freedom can be defined to enable the control element 2202 to perform movements that can be converted into movements of the hub and / or interventional device. For example, the control mechanism may be equipped with one or more deflection controls configured to initiate lateral deflection in a deflection region on the corresponding interventional device.

[0241] The axial movement of the control element can be configured to move the connected hub on a 1:1 scale or on a non-1:1 scale. For example, if user 2230 advances control element 2202 about 5 mm distally along shaft 2210, the corresponding hub can move 5 mm distally accordingly.

[0242] If user 2230 causes control 2202 to rotate about its axis (in) Figure 16B Rotating the hub (represented by A1) by 5 degrees will cause the corresponding interventional device to rotate on a 1:1 scale or a non-1:1 scale. The scaling amount can be selected to reduce or increase the distance the hub and / or interventional device moves and the amount of rotation as the control unit moves.

[0243] In some implementations, a scaling factor can be used to determine the amount of scaling described herein. The scaling factor can be applied to one or both of translational and rotational movements. In some implementations, a first scaling factor is selected for translational movements, and a second scaling factor, different from the first scaling factor, is selected for rotational movements. For a given proximal or distal operation of the control, the axial scaling factor can drive proximal catheter movement at a faster rate than distal catheter movement.

[0244] The rotational scaling factor can be 1:1, while the axial scaling factor can allow the hub to move a greater distance than the control component, such that the hub travel relative to the control component is at least about 2:1 or 5:1 or 10:1 or greater, depending on the desired axial length of the control component.

[0245] The control mechanism 2200 can be configured to allow clinicians to adjust the scaling factors for different parts of the procedure. For example, the advancement of the surgical catheter and access catheter by guiding the catheter and proceeding distally to the selected opening may ideally be accomplished in a “rapid” mode. However, the more distal advance into the neurovascular system may ideally be accomplished in a relatively slow mode by speed-controlled actuation.

[0246] In another embodiment, one or more controls can be configured to progressively drive the advance or retraction speed of the corresponding hub and associated catheter. For example, the distal control 2202 can drive the guide catheter. Slight distal movement of the control 2202 can advance the guide catheter distally at a slower speed, while advancing the control 2202 distally a greater distance increases the rate of distal travel of the guide catheter.

[0247] Axial or axial-rotational control of the corresponding hub speed can improve the overall speed of the procedure. For example, the advancement of various devices from the femoral entry point to the aortic arch can ideally be accomplished at a faster rate than distal navigation closer to the treatment site. Moreover, the proximal retraction of various devices, especially guidewires, access catheters, and surgical catheters, can ideally be achieved at a relatively higher speed than distal advancement.

[0248] Figure 16C Another example of manually operating controls on control mechanism 2200 to move hubs and / or other interventional devices is shown. In some embodiments, two or more controls 2202-2208 may be moved in combination to trigger movement of one or more hubs and / or associated interventional devices. In the depicted example, user 2230 moves controls 2204 and 2206 in combination (e.g., sequentially, simultaneously) to move the 0.088 guide catheter and the 0.071 aspiration catheter as a combination simultaneously. Example movement of control 2204 may include axial proximal movement in the direction indicated by arrow 2250. Sequentially or simultaneously, user 2230 may move control 2206 axially in either direction indicated by arrows 2254 and 2256, and may also rotate control 2206 in either direction indicated by arrows 2258 and 2260.

[0249] In some embodiments, each control mechanism and / or additional control element (not shown) may be color-coded, shape-coded, tactile-coded, or otherwise coded to indicate to the user 2230 which color is configured to move which hub or intervention device. In some embodiments, color coding of control elements may also be applied to hubs and / or intervention devices, allowing the user to visually match a specific hub / device with a specific control element.

[0250] In some embodiments, controllers 2202-2208 can perform control operations other than translational and rotational movements. For example, controllers 2202-2208 can be configured to drive changes in the shape and / or stiffness of the corresponding intervention device. Controllers 2202-2208 can switch between different operating modes. For example, controllers 2202-2208 can switch between movements driven by acceleration and velocity and movements reflecting actual linear displacement or rotation.

[0251] In some embodiments, the control mechanism 2200 may be equipped with an indicator of the relative position of a visual display or other control element, the relative position of which may correspond to the relative position of the interventional 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 element. In some embodiments, the display may depict applied forces or resistance encountered by the catheter or other measurements detected or observed by a particular hub or interventional component.

[0252] In some embodiments, the control mechanism 2200 may include a tactile component to provide tactile feedback to a user operating the control. For example, if the control 2202 triggers movement of the catheter and a large force is detected at the catheter tip, the control 2202 may generate tactile feedback to instruct the user to stop or reverse the movement. In some embodiments, tactile feedback may be generated at the control to instruct the user to use the control to slow or accelerate the movement. In some embodiments, tactile feedback may provide feedback for large torsional strain accumulation that may precede sudden rotation, or for large axial force accumulation that may be a precursor to catheter buckling.

[0253] The system described herein compares the actual position in a fluoroscopic image with the input displacement from a controller. Static fluoroscopic images of the patient can be captured, in which the patient's vascular system is indicated relative to bone landmarks or one or more implanted soft tissue reference landmarks. The real-time fluoroscopic image can then be displayed as an overlay, aligned with the static image through registration with the reference landmarks. Visual observation of the consistency between the real-time movement and the static image, aided by detected force data, can help confirm the correct navigation of the associated catheter or guidewire. The system described herein can also display a comparison of the proximal mechanical translation of the catheter or guidewire input with the resulting distal tip output motion or its absence. Loss of relative motion at the distal tip can indicate axial flexion, prolapse, kinking, or similar outcomes, either internally or externally. Such comparisons can be beneficial when axial flexion, prolapse, kinking, or similar outcomes occur outside the current fluoroscopic view.

[0254] Figure 17 A side elevation schematic of a multicatheter interventional device assembly 2900 for combined aortic and / or neurovascular site access and procedures (e.g., aspiration) is shown, as described herein. The multicatheter assembly 2900 can be configured for manual or robotic surgery.

[0255] Interventional device assembly 2900 includes an insertion or access catheter 2902, a surgical catheter 2904, and a guiding catheter 2906. Other components may include, but are not limited to, one or more guidewires (e.g., optional guidewire 2907), one or more guiding catheters, an access sheath, and / or one or more other surgical catheters and / or associated catheter (control) hubs. In some embodiments, assembly 2900 may also be configured with an optional deflection control 2908 for controlling the deflection of one or more catheters of assembly 2900.

[0256] During the procedure, the multi-catheter assembly 2900 can be used without replacing the hub assembly. For example, in the previously disclosed two-stage procedure, the first stage for achieving supra-aortic access includes mounting the access catheter, guide catheter, and guidewire onto the support platform. Upon achieving supra-aortic access, the access catheter and guidewire are typically removed from the guide catheter. Then, after attaching a new guidewire hub and surgical catheter hub to the corresponding drive trolley on the support platform, the second catheter assembly is introduced through the guide catheter.

[0257] Figure 17 The single multi-catheter assembly 2900 is configured to operate without removing the hub and catheter and without adding additional components and / or hubs. Therefore, the multi-component access and surgical configuration of assembly 2900 can utilize guidewire 2907, manufactured to serve as an access guidewire and navigation guidewire, to allow sufficient access and support, as well as navigation to a specific distal treatment site. In a non-limiting example configured for a robotic implementation, the catheter assembly may include a guidewire hub (e.g., guidewire hub 2909 or guidewire hub 26 located on the drive platform and to the right of catheter 2902), an insertion or access catheter hub 2910, a surgical catheter hub 2912, a guide catheter hub 2914, and a corresponding catheter. In some embodiments, one or more hubs may include or be connected to a hemostatic valve (e.g., a rotary hemostatic valve) to accommodate the introduction of an interventional device therethrough. Additional details regarding the hemostatic valve are contained in U.S. Patent Application Serial No. 17 / 879,614, entitled “Multi Catheter System With Integrated Fluidics Management,” filed August 2, 2022, which is incorporated herein by reference in its entirety.

[0258] Once the access above the aortic arch is completed, the insertion or access catheter 2902 (associated with the insertion or access catheter hub 2910) can be positioned near the carotid orifice, and the remainder or subset of the catheter assembly can be directed more distally to specific sites (e.g., clot site, surgical site, surgical site, etc.).

[0259] In some embodiments, other smaller surgical catheters may also be added and used at the site. As used in the catheter assembly 2900 described herein, in a robotic configuration of assembly 2900, a guide catheter 2906 may be used as a guide catheter. A surgical catheter 2904 may be used as a surgical (e.g., aspiration) catheter. In some embodiments, instead of or in addition to the surgical catheter 2904, the guide catheter 2906 may also serve as a guide catheter for aspiration. An access catheter 2902 may have a distal deflection region and may be used to access the desired opening. Those skilled in the art will... Figures 18A to 18E As understood in this paper, manual or robotic operation of multi-duct stacking is to be expected.

[0260] In some implementations, the catheter assembly 2900 (or other combined catheter assemblies described herein) can be driven to a location as an assembly. However, each catheter (or guidewire) assembly can be operated and driven to the same or different locations independently of each other.

[0261] In a non-limiting example, catheter assembly 2900 can be used for diagnostic angiography procedures. In some embodiments, assembly 2900 may include only a guidewire 2907 and an access catheter 2902 (in the form of a diagnostic angiography catheter) for performing diagnostic angiography procedures, or only the guidewire 2907 and the access catheter 2902 may be used during the procedure. Alternatively, the guiding catheter 2906 and the surgical catheter 2904 may be retracted proximally to expose the distal end of the access catheter 2902 (e.g., a few centimeters of the distal end of the access catheter) for diagnostic angiography.

[0262] like Figure 17 As shown, the guiding catheter 2906, surgical catheter 2904, access catheter 2902, and guidewire 2907 can be arranged concentrically. In some embodiments, the guiding catheter 2906 can be a "large-bore" guiding or access catheter having a diameter of at least about 0.075 inches or at least about 0.080 inches. The surgical catheter 2904 can be an aspiration catheter having a diameter of about 0.060 inches to about 0.075 inches. The access catheter 2902 can be a manipulable catheter with a deflectable distal tip having a diameter of about 0.025 inches to about 0.050 inches. The guidewire 2907 can have a diameter of about 0.014 inches to about 0.020 inches. In one example, the guiding catheter 2906 may have a diameter of about 0.088 inches, the surgical catheter 2904 may have a diameter of about 0.071 inches, the access catheter 2902 may have a diameter of about 0.035 inches, and the guidewire 2907 may have a diameter of about 0.018 inches.

[0263] Figures 18A to 18EAn exemplary sequence of steps for introducing a multi-catheter assembly configured to achieve direct access to the clot, either manually or robotically. Figures 18A to 18E It can be used Figure 17 The interventional device components are described in this document. Other combinations of catheters may be used instead of the interventional device components, as will be understood by those skilled in the art in light of the disclosure herein.

[0264] refer to Figure 18A The three-catheter interventional device assembly 2900 is shown being driven through the guide sheath 3002, ascending through the iliac artery 3004 and into the descending aorta. Subsequently, the access catheter 2902, the surgical catheter 2904 (e.g., 0.071 inches), and the guiding catheter 2906 (e.g., 0.088 inches) are tracked to the aortic arch 3006, as... Figure 18B As shown. Here, the distal end of the guiding catheter 2906 can be positioned below the aortic arch 3006, and the surgical catheter 2904, the entry catheter 2902 (located within the surgical catheter 2904, and...) Figure 18B The access catheter 2902 (not visible in the mouth) and guidewire 2907 can be driven into the mouth (e.g., simultaneously or separately). In some embodiments, the access catheter 2902 is advanced by the surgical catheter 2904 and the guiding catheter 2906 to first engage the mouth. After the distal end of the access catheter 2902 is positioned within the desired endooral region, the guidewire 2907 can be advanced distally into the mouth to secure access. After the access catheter 2902 and guidewire 2907 are positioned within the desired endooral region, the surgical catheter 2904 and / or guiding catheter 2906 can be advanced into the mouth (and in some embodiments, beyond the mouth), while using the support of the access catheter 2902 and / or guidewire 2907 to manipulate through the aorta and into the mouth. Figure 18B In the illustrated implementation, the surgical catheter 2904 has been advanced into the mouth, while the guiding catheter 2906 has been kept below the aortic arch 3006.

[0265] refer to Figure 18C Guidewire 2907 can be advanced distally, and the non-transmissive linearity of guidewire 2907 can be used to confirm, under fluoroscopic imaging, that entry through the desired opening has been achieved. Guidewire 2907 is engaged at the origin of the brachiocephalic artery 3014. Then, guidewire 2907 is advanced superiorly to the petrous segment 3018 of the internal carotid artery 3016.

[0266] refer to Figure 18D Guiding catheter 2906 and surgical catheter 2904 (located within guiding catheter 2906, and...) Figure 18D (Not visible in the middle) on guidewire 2907 and inserted or entered catheter 2902 (located within surgical catheter 2904, and in...) Figure 18DThe guide wire 2907 (not visible in the middle) is advanced, while the guide tube 2902 remains at the opening for support. The guide wire 2907 can be further advanced through the rock segment 3018 to the part of the clot 3020, such as segment M1.

[0267] refer to Figure 18E Guiding catheter 2906 and surgical catheter 2904 (located within guiding catheter 2906, and...) Figure 18E The guidewire 2907 (not visible in the middle) is advanced (e.g., simultaneously or sequentially) to position the distal tip of the surgical catheter 2904 at the surgical site, such as on the surface of the clot 3020. The guidewire 2907 is removed and the inlet catheter 2902 (located within the surgical catheter 2904, and...) is inserted. Figure 18E (Not visible in the middle), and aspiration of the clot 3020 begins through surgical catheter 2904. That is, guidewire 2907 and access catheter 2902 are retracted proximally to allow aspiration through surgical catheter 2904. After aspiration of the clot, surgical catheter 2904 and guide catheter 2906 can be removed (e.g., simultaneously or sequentially). For example, in some embodiments, surgical catheter 2904 can be removed before guide catheter 2906 is removed.

[0268] The catheter assembly 2900 can be used in neurovascular surgery, such as... Figures 18A to 18E As shown. For example, neurovascular surgery can be neurovascular thrombosis resection. The steps of the procedure may include providing a component that includes at least a guidewire, an access catheter, a guiding catheter, and a surgical catheter. For example, catheter assembly 2900 includes a guidewire 2907, an access (e.g., insertion) catheter 2902, a guiding catheter 2906, and at least one surgical catheter 2904. Surgical catheter 2904 may include an aspiration catheter, an embolization deployment catheter, a stent deployment catheter, a flow shunt deployment catheter, a diagnostic angiography catheter, a stent retrieval catheter, a clot retrieval catheter, a balloon catheter, a catheter facilitating percutaneous flap repair or replacement, an ablation catheter, and / or an RF ablation catheter or guidewire.

[0269] Neurovascular surgery may also include the following steps: connecting the component to a non-robotic or robotic-driven system, and driving the component to achieve access to the aorta. The steps may also include driving a subset of the component to the neurovascular site and performing neurovascular surgery using the subset of the component. The subset of the component may include guidewires, guiding catheters, and surgical catheters.

[0270] Each of the guidewire 2907, inlet catheter 2902, guide catheter 2906, and surgical catheter 2904 is configured to be adjusted by a corresponding hub. For example, guidewire 2907 may include (or be connected to) a hub mounted on one of the tray assemblies described herein. Similarly, inlet catheter 2902 may be connected to insertion or inlet catheter hub 2910. Guide catheter 2906 may be connected to guide catheter hub 2914. Surgical catheter 2904 may be connected to surgical catheter hub 2912.

[0271] Typically, the connection of the components may include magnetically connecting a first hub (e.g., guidewire hub 2909) connected to guidewire 2907 to a first drive magnet, a second hub (e.g., insertion or access catheter hub 2910) connected to access catheter 2902 to a second drive magnet, a third hub (e.g., surgical catheter hub 2912) connected to surgical catheter 2904 to a third drive magnet, and a fourth hub (e.g., guide catheter hub 2914) connected to guide catheter 2906 to a fourth drive magnet. Typically, the first, second, third, and fourth drive magnets are each independently and movably carried by a drive stage, as described by the tray assembly and controls herein. In some embodiments, the first, second, third, and fourth drive magnets are connected (e.g., connected to their respective catheter hubs) via sterile barriers (e.g., sterile and fluid barriers) and are independently movably carried by a drive stage having a plurality of driven magnets. In some implementations, two or more drive magnets may be bolted together or otherwise connected to each other to move as a unit in response to a command from a single controller bolted to one of the drive magnets or otherwise connected to it.

[0272] In some embodiments, the steps of performing neurovascular surgery may include driving an assembly in response to each movement of the hub adapter along a support platform until the assembly is positioned to achieve access to a superior aortic vessel. The hub adapter may include, for example, a connector / roller that acts as a shuttle, being advanced proximally or distally along a track in response to operator commands. The hub adapters described herein may each include at least one drive magnet configured to engage with a driven magnet carried by the respective hub. This provides a magnetic connection between the drive and driven magnets via a sterile barrier, such that the respective hub moves into the top of the sterile barrier (e.g., [missing information]) in response to movement of the hub adapter outside the sterile area. Figure 4 (As described in detail in the text). The movement of the hub adapter is driven by a drive system carried by a support platform on which the guidewire hub 2909, guide catheter hub 2914, surgical catheter hub 2912, and insertion or access catheter hub 2910 are mounted.

[0273] The steps may also include driving a subset of the components in response to each movement along the support platform in the hub adapter until the subset of components is positioned for neurovascular surgery at the neurovascular treatment site. The subset of components may include guidewire 2907, guiding catheter 2906, and surgical catheter 2904.

[0274] In some embodiments, the guidewire 2907, the guiding catheter 2906, and the surgical catheter 2904 pass as a combination (relative to the guidewire 2907) and over (relative to the guiding catheter 2906 and the surgical catheter 2904) at least a portion of the length of the access (e.g., insertion) catheter 2902 after achieving access to the aorta.

[0275] In some implementations, the catheter assembly 2900 may be part of a robotic control system for achieving access to the aorta and neurovascular treatment sites, such as... Figures 18A to 18E As shown. In some embodiments, the catheter assembly 2900 may be part of a manually controlled system for achieving supra-aortic access and neurovascular treatment site access. In some embodiments, the catheter assembly 2900 may be part of a hybrid control system (with manual and robotic components) for achieving supra-aortic access and neurovascular treatment site access. For example, in such a hybrid system, supra-aortic access may be robotically driven, while neurovascular site access and embolectomy or other procedures may be manual. Alternatively, in such a hybrid system, supra-aortic access may be manual, while neurovascular site access may be robotically performed. Furthermore, in such a hybrid system, any one or more of the guidewire, access catheter, guiding catheter, or surgical catheter may be robotically driven or manually operated.

[0276] The example robot control system may include at least a guidewire hub (e.g., guidewire hub 2909) configured to adjust each of the axial and rotational positions of guidewire 2907. The robot control system may also include an insertion catheter hub 2910 configured to adjust the axial and rotational movement of insertion catheter 2902. The robot control system may also include a guide catheter hub 2914 configured to control the axial movement of guide catheter 2906. The robot control system may also include a surgical catheter hub 2912 configured to adjust the axial and rotational positions of surgical catheter 2904.

[0277] In some implementations, the surgical catheter hub 2912 is also configured to laterally deflect the distal deflection region of the surgical catheter 2904.

[0278] In some embodiments, guidewire hub 2909 is configured to be connected to a guidewire hub adapter by magnetically connecting the guidewire hub to a first drive magnet. Insertion or entry catheter hub 2910 is configured to be connected to an entry catheter hub adapter by magnetically connecting the insertion or entry catheter hub 2910 to a second drive magnet. Surgical catheter hub 2912 is configured to be connected to a surgical catheter hub adapter by magnetically connecting the surgical catheter hub 2912 to a third drive magnet. Guiding catheter hub 2914 is configured to be connected to a guiding catheter hub adapter by magnetically connecting the guiding catheter hub 2914 to a fourth drive magnet. In some embodiments, the first, second, third, and fourth drive magnets are independently and movably carried by a drive stage.

[0279] In some embodiments, the robot control system includes a first driven magnet on the guidewire hub 2909. The first driven magnet can be configured to cooperate with a first driving magnet such that the first driven magnet is configured to move in response to movement of the first driving magnet. In some embodiments, the first driving magnet is configured to move through a barrier to the outside of a sterile area separated from the first driven magnet when the first driven magnet is within a sterile area. In some embodiments, the position of the first driven magnet can be moved in response to operation of surgical drive controls on a console associated with the drive stage. (See above reference) Figure 4 The interaction between the driving magnet and the driven magnet is described in detail.

[0280] In some embodiments, the robot control system includes a second driven magnet inserted into or entering the catheter hub 2910. The second driven magnet may be configured to cooperate with a second driving magnet such that the second driven magnet is configured to move in response to movement of the second driving magnet. In some embodiments, the second driving magnet is configured to move through a barrier to the outside of a sterile area separated from the second driven magnet while the second driven magnet is within a sterile area.

[0281] In some embodiments, the robot control system includes a third driven magnet on the surgical catheter hub 2912. The third driven magnet can be configured to cooperate with a third driving magnet such that the third driven magnet is configured to move in response to movement of the third driving magnet. In some embodiments, the third driving magnet is configured to move through a barrier to the outside of a sterile area separated from the third driven magnet when the third driven magnet is within a sterile area.

[0282] In some embodiments, the robot 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 actuating magnet, such that the fourth driven magnet is configured to move in response to movement of the fourth actuating magnet. In some embodiments, the fourth actuating magnet is configured to move through a barrier to the outside of a sterile area separated from the fourth driven magnet when the fourth driven magnet is within a sterile area. In some embodiments, there can be more than four driven magnets and corresponding catheter hubs for controlling additional catheters.

[0283] In some embodiments, the devices described herein (e.g., hubs, hub adapters, interventional devices, and / or trays) can be used in robot-operated surgeries. For example, in a robot-operated surgery, one or more interventional devices can be driven through the vascular system and reach the surgical site. Robotically operated devices may include electromechanical components that engage and are controlled by user input. In some embodiments, the user may provide input at a control system that interacts with one or more hubs and hub adapters.

[0284] In some implementations, the hub, hub adapter, interventional device, and tray described herein can be used during non-robotic (e.g., manually driven) procedures. Manually driving such a device may include manually engaging with the hub to influence the movement of the interventional device.

[0285] In some embodiments, the apparatus described herein can be used to perform intracranial surgery in an intracranial location. The method of performing intracranial surgery may include any of the same steps as those described herein for performing neurovascular surgery. The method may be performed robotically, manually, or a combination of both.

[0286] While the magnetic connection between the hub and the drive magnet has been described above, in other embodiments, any interventional device and / or hub may be mechanically connected to the drive system. Any method described herein may include the steps of mechanically connecting one or more interventional devices (e.g., guidewire 2907, insertion or access catheter 2902, surgical catheter 2904, and / or guiding catheter 2906) and / or one or more hubs (e.g., guidewire hub 2909, insertion or access catheter hub 2910, surgical catheter hub 2912, and / or guiding catheter hub 2914) to one or more drive mechanisms.

[0287] Figure 19A mechanical connection mechanism 1654 between the drive mechanism 1650 and the driven mechanism 1652 is shown. The drive mechanism 1650 and the driven mechanism 1652 may each have any features or functions identical or similar to those of the drive magnet 67 and the driven magnet 69, unless otherwise described herein. The drive mechanism 1650 may be part of or connected to a hub adapter (e.g., hub adapter 48). The driven mechanism 1652 may be part of or connected to a hub (e.g., hub 36, guidewire hub 2909, insertion or access catheter hub 2910, surgical catheter hub 2912, or guide catheter hub 2914). In some cases, the mechanical connection mechanism 1654 may include a structural support (e.g., a support rod or support strut) extending laterally through the seal in the sterile barrier 1632. When the drive mechanism 1650 and the driven mechanism 1652 are advanced and / or retracted as described herein, the seal can allow the structural support to be advanced along the length of the sterile barrier 1632 while still maintaining a seal with the structural support to preserve the sterile area. For example, the seal may include a tongue and groove closure mechanism along the sterile barrier 1632, configured to close on either side of the structural support while allowing the structural support to pass through the sterile barrier 1632 and holding the seal against the structural support as the structural support is advanced along the length of the sterile barrier 1632.

[0288] In some embodiments, the structural support may extend through an elongated self-closing seal (e.g., shaped like a duckbill valve) between two adjacent coaptive edges of a flexible material extending axially. As the structural support is advanced axially between the coaptive edges, the coaptive edges allow the structural support to advance, and then, as the structural support passes any given point along the axis, it can be biased back to a sealing engagement with each other.

[0289] In some embodiments, the drive mechanism may be a spline drive shaft (e.g., a non-sterile spline drive shaft). The mechanical connection mechanism 1654 may include pulleys within a plate serving as a sterile barrier 1632 and a sterile spline shaft configured to connect to the driven mechanism 1652. The driven mechanism 1652 may be a sterile pulley that receives a sterile spline shaft from the sterile barrier. In some embodiments, one or more spline drive shafts may engage and rotate corresponding pulleys in the plate serving as a sterile barrier. Each hub may have a sterile pulley configured to receive a sterile spline shaft from a sterile barrier plate. Rotation of the spline drive shaft can rotate pulleys in the sterile barrier plate, which in turn can rotate sterile pulleys in the hubs via the sterile spline shaft.

[0290] Those skilled in the art will understand that any of the embodiments described herein can be modified to incorporate a mechanical connection mechanism, for example, as Figure 19As shown.

[0291] The interventional devices described herein may be provided individually, or at least some of them may be provided in a pre-assembled (e.g., nested or stacked) configuration. For example, interventional devices may be provided in the form of interventional device assemblies (e.g., interventional device assembly 2900) in a concentric nested or stacked configuration. If provided individually, each catheter (and in some embodiments, each corresponding catheter hub) may be unpacked and pre-filled to remove air from its lumen, for example, by flushing the catheter (and in some embodiments, flushing the corresponding catheter hub) to remove air by displacing it with a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent). After pre-filling, the interventional devices may be manually assembled into a stacked configuration such that they are ready to be introduced into the body for surgical procedures, for example, via a guide sheath.

[0292] Assembling devices into a stacked configuration may include inserting interventional devices individually into each other in order of size. For example, an interventional device with the second largest diameter may be inserted into the lumen of an interventional device with the largest diameter. Then, an interventional device with the third largest diameter may be inserted into an interventional device with the second largest diameter, and so on.

[0293] For example, through Figure 17 Assembly can be performed by first inserting the distal end of surgical catheter 2904 through guide catheter hub 2914 and into guide catheter 2906. Surgical catheter 2904 can be advanced through guide catheter 2906 until the distal tip of surgical catheter 2904 is flush with or extends beyond the distal tip of guide catheter 2906, and / or until surgical catheter 2904 can no longer be inserted. Then, the distal end of catheter 2902 can be inserted through surgical catheter hub 2912 and into surgical catheter 2904. Catheter 2902 can be advanced through surgical catheter 2904 until the distal tip of catheter 2902 is flush with or extends beyond the distal tip of surgical catheter 2904, and / or until catheter 2902 can no longer be inserted. Then, the distal end of guidewire 2907 can be inserted through or into catheter hub 2910 and into catheter 2902. Guidewire 2907 can be advanced through catheter 2902 until the distal tip of guidewire 2907 is flush with or extends beyond the distal tip of catheter 2902, and / or until guidewire 2907 can no longer be inserted.

[0294] Implementations in which two or more interventional devices are packaged together as a single assembly in an assembled (e.g., nested or stacked) configuration can provide efficient unpacking and preparation before use, and efficient assembly within the robot control system. The interventional devices can be pre-installed into their respective hubs before packaging. In some embodiments, two or three or more interventional devices can be packaged in a fully nested (i.e., fully axially inserted) or nearly fully nested configuration. In a fully nested configuration, each interventional device is inserted as far as possible into the adjacent distal hub and interventional device. Such a fully nested configuration minimizes the overall length of the interventional device assembly and the size of the package required to house the interventional device assembly.

[0295] In some embodiments, the interventional device may also be sterilized prior to packaging while in an assembled configuration, for example, using ethylene oxide gas. In some embodiments, the interventional device may be packaged in an assembled configuration prior to sterilization with ethylene oxide gas. For nested or stacked configurations of interventional devices, ethylene oxide gas may be supplied for sterilization in the space between adjacent interventional devices (e.g., an annular lumen between the outer diameter of a first interventional device nested within a second interventional device and the inner diameter of a second interventional device). In some embodiments, the interventional device assembly may be packaged in a thermoformed tray and sealed with an HDPE (e.g., Tyvek®) cap. The interventional device assembly can be unpacked by the user removing (e.g., opening or peeling) the cap in a non-sterile area. The user in a sterile area can then remove the interventional device assembly and place it on a sterile working surface, such as a robotic stage, as described herein.

[0296] Packaging interventional devices in an assembled and sterilized state reduces the time associated with unpacking and assembling individual interventional devices and facilitates efficient connection to robot drive systems. Each combination of interventional device and hub may also include a fluidic connection for connection to a fluid source and / or vacuum source. In some embodiments, each hub or hemostatic valve connected to the hub may include a fluidic connection.

[0297] After unpacking the interventional device assembly (e.g., after positioning the interventional device assembly on a robotic stage), pre-filling can be performed while the devices are concentrically nested or stacked. This is preferably done in each fluid lumen, such as, for example, the annular lumen between guide catheter 2906 and surgical catheter 2904, and between each additional concentric interventional device in the concentric stack. In some embodiments, the fluid lumen may include a lumen between the distal hub and the proximal interventional device, such as, for example, the lumen between guide catheter hub 2914 and surgical catheter 2904. In some embodiments, pre-filling can be performed while the device is still in sterile packaging. A fluidic connection can be attached to a fluidic system for delivering saline and contrast agent to the catheters and providing aspiration. In some embodiments, the fluidic connection can be extended outside the sterile area for attachment to the fluidic system. Once attached, the fluidic system can perform a series of pre-fillings to flush each catheter in the interventional device assembly with fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent). A series of pre-fillings may also include flushing each corresponding catheter hub with fluid. The fluid can be de-aired or degassed by the fluid dynamics system prior to pre-filling. In some embodiments, the vacuum source of the fluid dynamics system can also be used to evacuate air from each catheter while flushing with fluid. In some embodiments, the catheter tip can be placed in a container of fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) during pre-filling, such that when a vacuum source is applied, the fluid in the container, rather than air, is drawn through the catheter tip. In other embodiments, the catheter tip can be sealed (e.g., using a plug) so that air is not drawn from the catheter tip when a vacuum source is applied. In some embodiments, the pre-filling process can be automated, allowing the user to provide a single command, and each catheter (and in some embodiments, each corresponding catheter hub) can be pre-filled sequentially or simultaneously (e.g., by means of...). Figures 20A to 20C (As described).

[0298] Additional details describing the fluid dynamics system are provided in U.S. Patent Application Serial No. 17 / 879,614, entitled “Multi Catheter System With Integrated Fluidics Management,” filed August 2, 2022, which is expressly incorporated herein by reference in its entirety.

[0299] When the cross-sectional area of ​​the lumen used for flow decreases, for example, when a second interventional device (e.g., a catheter or guidewire) extends within the lumen of a first interventional device, the fluid resistance within the lumen can be greater. For example, the amount of fluid resistance can be affected by the narrowing of the cross-sectional length due to the depth of axial insertion of the second interventional device within the first interventional device. A second interventional device that partially extends through the lumen of the first interventional device will provide a smaller cross-sectional narrowing, and thus may result in lower fluid resistance within the lumen of the first catheter compared to the case where the second interventional device extends fully through the lumen of the first interventional device. Therefore, fluid resistance can be reduced by at least partially reducing the depth of axial insertion (i.e., axial overlap) of the second interventional device into the lumen through which fluid is injected (e.g., the length of the second interventional device entering its concentrically adjacent lumen).

[0300] In some embodiments, at certain insertion depths of the second interventional device within the first interventional device (e.g., when the second interventional device is at or near the maximum insertion depth within the first interventional device), the size of the fluid passage between the devices (e.g., an annular cavity between the first and second interventional devices) can result in an amount of fluid resistance higher than desired during the pre-filling process. In some embodiments, the insertion depth of the second interventional device within the first interventional device can be reduced to decrease the pressure required for pre-filling the catheter and to reduce internal disturbances.

[0301] In some implementations, the catheter in the interventional device assembly can be dissociated from other interventional devices for pre-filling to reduce the pressure required for pre-filling the catheter and minimize internal disturbances. The catheter to be pre-filled can be dissociated from the interventional device within the catheter's lumen by retracting the interventional device proximally within the catheter's lumen. For example, the interventional device within the lumen of the catheter to be pre-filled can be retracted as far proximally as possible from the catheter to be pre-filled 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 for pre-filling the catheter and minimize internal disturbances. In other words, the catheter can be dissociated from a more proximal interventional device for pre-filling while the distal tip of the adjacent interventional device remains within the catheter's lumen. Retaining at least some of the distal tips of the adjacent interventional devices within the catheter's lumen allows for easier reinsertion and advancement of the proximal interventional device after pre-filling.

[0302] In some embodiments, the axial overlap can be about 2 cm to about 20 cm, about 2 cm to 10 cm, about 2 cm to 5 cm, about 5 cm to 20 cm, about 5 cm to 10 cm, or any other suitable range. In some embodiments, the axial overlap can be at least about 2 cm, at least about 5 cm, at least about 10 cm, at least about 20 cm, no more than 2 cm, no more than 5 cm, no more than 10 cm, no more than 20 cm, about 2 cm, about 5 cm, about 10 cm, about 20 cm, or any other suitable amount.

[0303] In some embodiments, the robotic stage can be programmed to retract the internal interventional device as far proximally as possible from the catheter to be pre-filled, while still maintaining a nested or stacked relationship. In other embodiments, the robotic stage can be programmed to disengage the internal device from the catheter to be pre-filled by a distance sufficient to optimize the length of the unobstructed lumen and result in fluid resistance below a threshold. After the catheter to be pre-filled is disengaged from the other interventional devices, it can be pre-filled by flushing the catheter with a fluid such as saline, contrast agent, or a mixture of saline and contrast agent.

[0304] After the catheter is pre-filled, it can return to its initial position, and the next catheter in the interventional device assembly can be dissociated from the other interventional devices within its lumen for pre-filling. This sequence can be repeated for each catheter in the interventional device assembly. In other embodiments, after the catheter is pre-filled, it can be advanced to a ready or driven position to begin insertion into the patient. While the dissociation of the catheter to be pre-filled by retraction of the internal interventional device has been described above, the external catheter can also be dissociated from the internal interventional device by axially advancing the external catheter distally relative to the internal interventional device. Figures 20A to 20C This describes an example of the pre-charge process.

[0305] Figure 20A An interventional device assembly 2900 is depicted in a configuration of concentric stacking and axial compression. (Example) Figure 20A As shown, the interventional devices can be completely nested within each other. This can be a configuration after the device assembly 2900 has been unpacked and placed on the robot drive stage. A series of pre-filling can be initiated by axially advancing the guide catheter 2906 and guide catheter hub 2914 distally relative to the surgical catheter 2904, surgical catheter hub 2912, catheter 2902, insertion or access catheter hub 2910, guidewire 2907, and guidewire hub 2909, for example, advancing as far as possible while holding the distal tip of the surgical catheter 2904 within the lumen of the guide catheter 2906, as... Figure 20BAs shown, or advanced to a distance that would result in the desired amount of fluid resistance for pre-filling. 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 pre-filled by introducing pre-filling fluid using a fluidic system. In some embodiments, the pre-filling fluid is introduced in response to a control signal from a control system. The pre-filling guide catheter 2906 may include a pre-filling guide catheter hub 2914. For example, in some embodiments, the guide catheter hub 2914 or a hemostatic valve connected thereto may include a fluidic connection to receive pre-filling fluid from the fluidic system. After pre-filling, the guide catheter 2906 may be returned to its initial position (e.g., a fully axially compressed configuration), as... Figure 20A As shown. In some embodiments, the guide conduit 2906 is returned to its initial position in response to a control signal from the control system.

[0306] After the guiding catheter 2906 is pre-filled and returned to its initial position, the surgical catheter 2904 and surgical catheter hub 2912 can be axially advanced distally relative to catheter 2902, inserted or inserted into catheter hub 2910, guidewire 2907, and guidewire hub 2909 (and also axially advanced distally to guiding catheter 2906 and guiding catheter hub 2914 without changing or minimally changing their relative positions to surgical catheter 2904), for example, advanced as far as possible while keeping the distal tip of catheter 2902 within the lumen of surgical catheter 2904, such as... Figure 20C As shown, or advanced to a distance that would result in the desired amount of fluid resistance for pre-filling. In some embodiments, surgical catheter 2904 and guide catheter 2906 are advanced in response to a control signal from a control system. Surgical catheter 2904 can then be pre-filled by introducing pre-filling fluid using a fluidic system. In some embodiments, pre-filling fluid is introduced in response to a control signal from a control system. Pre-filling surgical catheter 2904 may include a pre-filling surgical catheter hub 2912. For example, in some embodiments, surgical catheter hub 2912 or a hemostatic valve connected thereto may include a fluidic connection to receive pre-filling fluid from a fluidic system. After pre-filling, surgical catheter 2904 and guide catheter 2906 may be returned to their initial positions (e.g., a fully axially compressed configuration), such as... Figure 20A As shown. In some embodiments, the surgical catheter 2904 and the guiding catheter 2906 are returned to their initial positions in response to a control signal from the control system.

[0307] After the surgical catheter 2904 is pre-filled and returned to its initial position, catheter 2902 and insertion or access catheter hub 2910 can be axially advanced distally relative to guidewire 2907 and guidewire hub 2909 (and also axially advanced distally to guide catheter 2906, guide catheter hub 2914, surgical catheter 2904, and surgical catheter hub 2912 without changing or minimally changing their relative positions to catheter 2902), for example, advanced as far as possible while retaining the distal tip of guidewire 2907 within the lumen of catheter 2902, or advanced to a distance that will result in the desired amount of fluid resistance used for pre-filling. In some embodiments, catheter 2902, surgical catheter 2904, and guide catheter 2906 are advanced in response to a control signal from a control system. Catheter 2902 can then be pre-filled by introducing pre-filling fluid using a fluid dynamics system. In some embodiments, pre-filling fluid is introduced in response to a control signal from a control system. Pre-filled catheter 2902 may include pre-filled insertion or access to catheter hub 2910. For example, in some embodiments, the hemostatic valve inserted into or connected to catheter hub 2910 may include a fluidic connection to receive pre-filled fluid from a fluidic system. After pre-filling, catheters 2902 and 2904 and 2906 may be returned to... Figure 20A Their initial positions are shown (e.g., in a fully axially compressed configuration). In some embodiments, catheter 2902, surgical catheter 2904, and guiding catheter 2906 are returned to their initial positions in response to a control signal from the control system.

[0308] In some implementation schemes, through Figures 20A to 20C The described pre-charge procedure can be performed in response to a single control signal from the control system. In other embodiments, the various steps of the pre-charge procedure can be performed in response to unique control signals. In some embodiments, pre-charging of each unique intervention device can be performed in response to a unique control signal.

[0309] In alternative implementations, each of the catheters can be simultaneously dissociated distally from each other for pre-filling. For example, catheter 2902 can be dissociated distally from guidewire 2907 while retaining the distal tip of guidewire 2907 within the lumen of catheter 2902; surgical catheter 2904 can be dissociated distally from catheter 2902 while retaining the distal tip of catheter 2902 within the lumen of surgical catheter 2904; and guiding catheter 2906 can be dissociated distally from surgical catheter 2904 while retaining the distal tip of surgical catheter 2904 within the lumen of guiding catheter 2906. However, as by Figures 20A to 20CAs described, the implementation involves separating only one set of adjacent hubs at a time, providing a smaller total component length at any given time, which allows for use with smaller robot-driven systems. Although the separation of external catheters from their internal interventional devices is described as advancing the catheter distally axially relative to their internal interventional devices, separation may include retracting the internal interventional device proximally from the external catheter.

[0310] In an alternative implementation, one or more of catheters 2902, surgical catheter 2904, and guiding catheter 2906 may be advanced to a preparatory or driven position to begin insertion into the patient after pre-filling (e.g., before pre-filling a subsequent catheter). In such an implementation, the catheters may be advanced to a preparatory or driven position without returning to their initial position after pre-filling.

[0311] As described above, in some embodiments, catheters 2902, 2904, and 2906 can be assembled before flushing the catheter. Figure 17 The concentric stack orientation shown is for removing air by displacing it with a fluid (e.g., saline contrast agent or a mixture of saline and contrast agent). This is preferably done in each fluid lumen, such as, for example, the annular lumen between guide catheter 2906 and surgical catheter 2904, and between each of any additional concentric interventional devices in the concentric stack. Infusing the fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure can displace substantially all the air, but may retain some small air bubbles that adhere to the inner wall of the outer catheter (e.g., guide catheter 2906), the outer wall of the inner catheter (e.g., surgical catheter 2904), or both.

[0312] When fluid is introduced under pressure into the proximal end of the annular lumen (e.g., into the hub of the outer catheter or a hemostatic valve attached thereto), the inner catheter can move relative to the outer catheter to disrupt the retaining forces between the microbubbles and adjacent walls, allowing the bubbles to be carried downstream and drained through the distal opening of the lumen or removed via aspiration. The catheters can move axially, rotationally, or axially and rotationally relative to each other. In some embodiments, the catheters can reciprocate axially, rotationally, or axially and rotationally relative to each other. In some embodiments, the catheters can move reciprocally, axially, rotationally, or reciprocally axially and rotationally. In other embodiments, the catheters can rotate continuously or rotate in a constant direction.

[0313] In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, axially reciprocating over a travel length of about 1 mm to about 250 mm, about 10 mm to about 250 mm, about 5 mm to about 125 mm, about 25 mm to about 125 mm, about 10 mm to about 50 mm, about 15 mm to about 30 mm, about 5 mm to about 30 mm, about 15 mm to about 25 mm, about 20 mm to about 40 mm, or any other suitable range. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, over a travel length of at least 5 mm, at least 10 mm, at least 15 mm, at least 20 mm, at least 25 mm, at least 30 mm, at least 50 mm, not exceeding 10 mm, not exceeding 20 mm, not exceeding 25 mm, not exceeding 30 mm, not exceeding 50 mm, not exceeding 125 mm, not exceeding 150 mm, about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 50 mm, or any other suitable travel length.

[0314] In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, axially reciprocating at a reciprocating frequency of about 0.5 Hz to about 1 Hz, about 1 Hz to about 5 Hz, about 1 Hz to about 10 Hz, about 1 Hz to about 25 Hz, about 5 Hz to about 10 Hz, about 10 Hz to about 25 Hz, or any other suitable frequency range. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, axially reciprocating at a reciprocating frequency of at least 0.5 Hz, at least 1 Hz, at least 2 Hz, at least 5 Hz, at least 10 Hz, at least 25 Hz, not exceeding 0.5 Hz, not exceeding 1 Hz, not exceeding 2 Hz, not exceeding 5 Hz, not exceeding 10 Hz, not exceeding 25 Hz, about 0.5 Hz, about 1 Hz, about 2 Hz, about 5 Hz, about 10 Hz, about 25 Hz, or any other suitable frequency range.

[0315] In one implementation, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, axially reciprocating over a travel length of about 0.5 inches to about 10 inches, or axially reciprocating over a travel length of about 1 inch to about 5 inches at a reciprocating frequency of no more than about 5 cycles / second or two cycles / second or less.

[0316] In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, at intervals of about 5 degrees to about 180 degrees, about 5 degrees to about 360 degrees, about 15 degrees to about 180 degrees, about 15 degrees to about 150 degrees, about 15 degrees to about 120 degrees, about 15 degrees to about 90 degrees, about 15 degrees to about 60 degrees, about 15 degrees to about 30 degrees, about 30 degrees to about 180 degrees, about 30 degrees to about 150 degrees, about 30 degrees to about 120 degrees, and about 30 degrees. Rotational reciprocating movement within a range of approximately 90 degrees, approximately 30 degrees to approximately 60 degrees, approximately 60 degrees to approximately 180 degrees, approximately 60 degrees to approximately 150 degrees, approximately 60 degrees to approximately 120 degrees, approximately 60 degrees to approximately 90 degrees, approximately 90 degrees to approximately 180 degrees, approximately 90 degrees to approximately 150 degrees, approximately 90 degrees to approximately 120 degrees, approximately 120 degrees to approximately 180 degrees, approximately 120 degrees to approximately 150 degrees, approximately 150 degrees to approximately 180 degrees, or any other suitable range of rotation angle / stroke. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, by a rotational angle / stroke of at least 5 degrees, at least 15 degrees, at least 30 degrees, at least 60 degrees, at least 90 degrees, at least 120 degrees, at least 150 degrees, at least 180 degrees, at least 360 degrees, not exceeding 5 degrees, not exceeding 15 degrees, not exceeding 30 degrees, not exceeding 60 degrees, not exceeding 90 degrees, not exceeding 120 degrees, not exceeding 150 degrees, not exceeding 180 degrees, not exceeding 360 degrees, about 5 degrees, about 15 degrees, about 30 degrees, about 60 degrees, about 90 degrees, about 120 degrees, about 150 degrees, about 180 degrees, about 360 degrees, or any other suitable angle.

[0317] In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, at a reciprocating frequency of about 0.5 Hz to about 1 Hz, about 1 Hz to about 5 Hz, about 1 Hz to about 10 Hz, about 1 Hz to about 25 Hz, about 5 Hz to about 10 Hz, about 10 Hz to about 25 Hz, or any other suitable frequency range. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, at a reciprocating frequency of at least 0.5 Hz, at least 1 Hz, at least 2 Hz, at least 5 Hz, at least 10 Hz, at least 25 Hz, not exceeding 0.5 Hz, not exceeding 1 Hz, not exceeding 2 Hz, not exceeding 5 Hz, not exceeding 10 Hz, not exceeding 25 Hz, about 0.5 Hz, about 1 Hz, about 2 Hz, about 5 Hz, about 10 Hz, about 25 Hz, or any other suitable frequency range.

[0318] In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire for a number of reciprocating movements within a suitable range, such as 1 to 200 times, 1 to 100 times, 1 to 50 times, 1 to 25 times, 1 to 15 times, 1 to 10 times, 1 to 5 times, 5 to 25 times, 5 to 15 times, 5 to 10 times, or any other suitable range. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire for at least one reciprocation, at least two reciprocations, at least five reciprocations, at least ten reciprocations, at least 15 reciprocations, at least 25 reciprocations, at least 50 reciprocations, no more than five reciprocations, no more than ten reciprocations, no more than 15 reciprocations, no more than 25 reciprocations, no more than 50 reciprocations, no more than 100 reciprocations, no more than 200 reciprocations, approximately one reciprocation, approximately two reciprocations, approximately five reciprocations, approximately 10 reciprocations, approximately 25 reciprocations, approximately 50 reciprocations, approximately 100 reciprocations, approximately 200 reciprocations, or any other suitable number of reciprocating movements. A single reciprocating movement may include a movement (axial or rotational) from a first position to a second position, followed by a return from the second position to the first position.

[0319] In some embodiments, the first catheter is moved back and forth relative to an adjacent catheter or guidewire over a time length of about 1 second to about 60 seconds, about 1 second to about 45 seconds, about 1 second to about 30 seconds, about 1 second to about 20 seconds, about 1 second to about 15 seconds, about 1 second to about 10 seconds, about 5 seconds to about 45 seconds, about 5 seconds to about 30 seconds, about 5 seconds to about 20 seconds, about 5 seconds to about 15 seconds, from about 5 seconds to about 10 seconds, about 10 seconds to about 30 seconds, about 10 seconds to about 20 seconds, or any other suitable range. In some embodiments, the first catheter is moved back and forth relative to the adjacent catheter or guidewire for a time length of at least 1 second, at least 5 seconds, at least 10 seconds, at least 15 seconds, at least 20 seconds, at least 30 seconds, at least 45 seconds, at least 60 seconds, no more than 5 seconds, no more than 10 seconds, no more than 15 seconds, no more than 20 seconds, no more than 30 seconds, no more than 45 seconds, no more than 60 seconds, about 5 seconds, about 10 seconds, about 15 seconds, about 20 seconds, about 30 seconds, about 45 seconds, about 60 seconds, or any other suitable time length.

[0320] The reciprocating movement of adjacent catheters to disrupt microbubbles can be accomplished by manually grasping the corresponding catheter hubs and manually moving the catheters axially or rotationally relative to each other while delivering pressurized fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent). Alternatively, for example in a robot-driven system, the processor can be configured to robot-driven at least one of two adjacent catheter hubs (e.g., at least one of guide catheter hub 2914 and surgical catheter hub 2912) to achieve relative movement between adjacent catheters, thereby disrupting and expelling microbubbles, for example in response to user activation of flushing control. For example, in some embodiments, two adjacent interventional devices can be moved relative to each other in response to a control signal from a control system. In some embodiments, the delivery of pressurized fluid can be performed in response to a control signal from a control system.

[0321] The reciprocating movement of adjacent catheters can generate shear forces to remove 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 pre-filling compared to a static surface. In some embodiments, the shear force can be increased by increasing the flow rate of the solution (e.g., saline, contrast agent, or a mixture of saline and contrast agent) supplied by the fluid dynamics system. In some embodiments, the flow rate and relative movement between adjacent catheters are controlled to remove air bubbles.

[0322] In some implementations, after each catheter is pre-filled by the fluid dynamics system, an ultrasonic bubble detector can be used to confirm that the catheter is substantially free of air bubbles. For example, an ultrasonic chip (e.g., mounted in a hub adjacent to the catheter receiving lumen) can extend along the length of the catheter to confirm that no air bubbles remain in the system.

[0323] pass Figures 21A to 21B An example of a pre-filling process involving the reciprocating movement of adjacent catheters is described.

[0324] Figure 21A An intervention device assembly 2900 assembled in a concentric stack configuration is depicted. For example... Figure 21A As shown, the intervention devices can be completely nested within each other. This can be a configuration after device assembly 2900 has been unpacked and placed onto the robot drive stage. Alternatively, individual intervention devices of device assembly 2900 can be assembled into device assembly 2900 on the drive stage.

[0325] A series of pre-filling processes can be initiated by pre-filling the guide catheter 2906. In some embodiments, the guide catheter 2906 can be pre-filled by introducing fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) into the lumen of the guide catheter 2906 under pressure, simultaneously generating axial, rotational, or axial-and-rotational reciprocating movement of the guide catheter 2906 and / or the guide catheter hub 2914 relative to the surgical catheter 2904. Pre-filling the guide catheter 2906 may include pre-filling the guide catheter hub 2914. For example, in some embodiments, the guide catheter hub 2914 or a hemostatic valve connected thereto may include a fluidic connection to receive pre-filling fluid from a fluidic system. In some embodiments, the guide catheter 2906 and / or the guide catheter hub 2914 may be along the longitudinal axis of the guide catheter 2906 (in... Figure 21A and Figure 21B (represented by axis A5) is axially stirred back and forth (e.g., in...) Figure 21A Location and Figure 21B (between positions). The axial and / or rotary reciprocating motion of the guide conduit 2906 and / or guide conduit hub 2914 can be performed manually or via a robotic drive. The reciprocating motion can be generated in response to a control signal from the control system. The introduction of fluid under pressure can be performed in response to a control signal from the control system.

[0326] In some embodiments, pre-filling of the guiding catheter 2906 can be performed by introducing fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of the guiding catheter 2906, simultaneously generating axial, rotational, or axial-rotational reciprocating movement of the surgical catheter 2904 and / or the surgical catheter hub 2912 relative to the guiding catheter 2906. The axial and / or rotational reciprocating movements of the surgical catheter 2904 and / or the surgical catheter hub 2912 can be performed manually or via a robotic stage. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of fluid under pressure can be performed in response to a control signal from a control system.

[0327] In some embodiments, pre-filling of the guiding catheter 2906 can be achieved by introducing fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) into the lumen of the guiding catheter 2906 under pressure, simultaneously generating axial, rotational, or axial-rotational reciprocating movement of both the guiding catheter 2906 (and / or the guiding catheter hub 2914) and the surgical catheter 2904 (and / or the surgical catheter hub 2912) relative to each other. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of fluid under pressure can also be performed in response to a control signal from a control system.

[0328] In some implementations, after pre-filling the guiding catheter 2906, the guiding catheter 2906 can be returned to, for example... Figure 21A The initial position is shown. In other embodiments, after pre-filling the guiding catheter 2906, the guiding catheter 2906 can be advanced to a ready or driven position to begin insertion into the patient.

[0329] In some embodiments, surgical catheter 2904 may be pre-filled after guide catheter 2906 has been pre-filled. Pre-filling surgical catheter 2904 may include a pre-filled surgical catheter hub 2912. For example, in some embodiments, surgical catheter hub 2912 or a hemostatic valve connected thereto may include a fluidic connection to receive pre-fill fluid from a fluidic system. In some embodiments, surgical catheter 2904 may be pre-filled by introducing fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of surgical catheter 2904, simultaneously generating axial, rotational, or axial-and-rotational reciprocating movement of surgical catheter 2904 and / or surgical catheter hub 2912 relative to catheter 2902. The reciprocating movement may be generated in response to a control signal from a control system. The introduction of fluid under pressure may be performed in response to a control signal from a control system.

[0330] In some embodiments, pre-filling of the surgical catheter 2904 can be performed by introducing fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of the surgical catheter 2904, simultaneously generating axial, rotational, or axial-rotational reciprocating motion of the catheter 2902 and / or insertion or entry into the catheter hub 2910 relative to the surgical catheter 2904. The axial and / or rotational reciprocating movement of the catheter 2902 and / or insertion or entry into the catheter hub 2910 can be performed manually or via a robotic stage. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of fluid under pressure can be performed in response to a control signal from a control system.

[0331] In some embodiments, pre-filling of the surgical catheter 2904 can be achieved by introducing fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) into the lumen of the surgical catheter 2904 under pressure, simultaneously generating axial, rotational, or axial-rotational reciprocating movement of both the surgical catheter 2904 (and / or the surgical catheter hub 2912) and the catheter 2902 (and / or insertion or insertion into the catheter hub 2910) relative to each other. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of fluid under pressure can also be performed in response to a control signal from a control system.

[0332] In some implementations, after pre-filling the surgical catheter 2904, the surgical catheter 2904 can be returned to, for example... Figure 21AThe initial position is shown. In some embodiments, after prefilling the surgical catheter 2904, the surgical catheter 2904 can be advanced to a ready or driven position to begin insertion into the patient.

[0333] In some embodiments, catheter 2902 may be pre-filled after surgical catheter 2904 has been pre-filled. Pre-filling catheter 2902 may include pre-filling insertion or entry catheter hub 2910. For example, in some embodiments, the hemostatic valve inserted into or connected to catheter hub 2910 may include a fluidic connection to receive pre-filling fluid from a fluidic system. In some embodiments, catheter 2902 may be pre-filled by introducing fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of catheter 2902, simultaneously generating axial, rotational, or axial-and-rotational reciprocating movement of catheter 2902 and / or insertion or entry catheter hub 2910 relative to guidewire 2907. Reciprocating movement may be generated in response to a control signal from a control system. Introducing fluid under pressure may be performed in response to a control signal from a control system.

[0334] In some embodiments, pre-filling of catheter 2902 can be performed by introducing fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) into the lumen of catheter 2902 under pressure, simultaneously generating axial, rotational, or axial-rotational reciprocating motion of guidewire 2907 and / or guidewire hub 2909 relative to catheter 2902. The axial and / or rotational reciprocating movement of guidewire 2907 and / or guidewire hub 2909 can be performed manually or via a robotic drive. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of fluid under pressure can be performed in response to a control signal from a control system.

[0335] In some embodiments, pre-filling of catheter 2902 can be achieved by introducing fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) into the lumen of catheter 2902 under pressure, simultaneously generating axial, rotational, or axial-rotational reciprocating movement of both catheter 2902 (and / or insertion into catheter hub 2910) and guidewire 2907 (and / or guidewire hub 2909) relative to each other. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of fluid under pressure can also be performed in response to a control signal from a control system.

[0336] In some implementations, after pre-filling catheter 2902, catheter 2902 can be returned to, for example... Figure 21A The initial position is shown. In other embodiments, after prefilling catheter 2902, catheter 2902 can be advanced to a ready or driven position to begin insertion into the patient.

[0337] In some implementation schemes, through Figure 21A and Figure 21B The described pre-charge procedure can be performed in response to a single control signal from the control system. In other embodiments, the various steps of the pre-charge procedure can be performed in response to unique control signals. In some embodiments, pre-charging of a unique intervention device can be performed in response to a unique control signal.

[0338] In this article Figure 21A and Figure 21B In the described series of pre-filling procedures, the catheters are pre-filled sequentially, starting with the guiding catheter 2906, followed by the surgical catheter 2904, and then the catheter 2902. However, it is conceivable that the catheters can be pre-filled in any order. The catheters can be pre-filled as described above. Figure 21A and Figure 21B They are pre-filled in series as described. Alternatively, two or more catheters or each catheter may be pre-filled in parallel.

[0339] In some embodiments, the pre-filled catheter may include reducing the depth to which the second interventional device is axially inserted (i.e., axially overlapped) into the lumen of the first interventional device, through which fluid is injected (e.g., the length of the second interventional device enters its concentrically adjacent lumen), such as by... Figures 20A to 20C As described, and also during pre-charging, relative reciprocating movement is generated between the first intervention device and the second intervention device axially, rotationally, or axially and rotationally, as by Figure 21A and Figure 21B As described.

[0340] In some embodiments, pre-filling of the conduit may include vibrating at least a portion of the conduit and / or its associated hub (when the associated hub is included). Vibration may be induced, for example, by a motor integrated into the hub of the conduit, or by a separate motor or a vibration source placed on the conduit during pre-filling. In some embodiments, at least a portion of a support platform on which the conduit and / or its associated hub is placed may vibrate during pre-filling of any one or more conduits to help remove air and / or air bubbles. Such vibration may be performed by a motor.

[0341] Example

[0342] Additional embodiments are disclosed in more detail in the embodiments described below, but these embodiments are not intended to limit the scope of the claims in any way.

[0343] Figure 22This is a diagram of a test system for detecting air bubble removal between concentrically stacked catheters. The test system includes an inner catheter 2108 located within the lumen of an outer catheter 2106 concentrically stacked. The outer catheter 2106 is connected to a rotary hemostatic valve 2104. The hemostatic valve 2104 is connected to a syringe 2102, such that fluid injected using the syringe will flow through the lumen between the inner catheter 2108 and the outer catheter 2106. In the test system, the inner catheter 2108 has a diameter of approximately 0.071 inches. The outer catheter 2106 has a diameter of approximately 0.088 inches. The outer catheter 2106 is transparent to allow observation of air bubbles within the lumen. The distal end of the outer catheter 2108 allows a small volume of fluid to exit the outer catheter. Figure 23A It is a photograph showing concentrically stacked catheters 2106 and 2108 before fluid injection. Figure 23D This is its illustration.

[0344] Example 1

[0345] In the first embodiment, syringe 2102 is used to inject water at a constant pressure of about 150 psi through hemostasis valve 2104 without moving catheter 2106 or catheter 2108. Figure 23B It is a photograph showing tubing 2106 and tubing 2108 after water has been injected. Figure 23E This is its illustration. (See diagram below.) Figure 23B As shown, air bubbles exist in the lumen between catheters 2106 and 2108.

[0346] Example 2

[0347] In the second embodiment, syringe 2102 is used to inject water at a constant pressure of approximately 150 psi through hemostasis valve 2104. Shortly after the injection begins, axial reciprocating movement of inner catheter 2108 is performed for approximately 10 seconds. The reciprocating movement is performed at a frequency of approximately 1 Hz (or lower) and a stroke length of approximately 20 mm (or more). Figure 23C It is a photograph showing catheters 2106 and 2108 after axial reciprocating movement. Figure 23F This is its illustration. (See diagram below.) Figure 23C As shown, the lumen between catheters 2106 and 2108 is essentially free of air bubbles.

[0348] Example 3

[0349] In the third embodiment, an outer catheter with a diameter of approximately 0.071 inches and an inner catheter with a diameter of approximately 0.035 inches were used in the test system 2100, instead of the outer catheter 2106 and inner catheter 2108 described in Examples 1 and 2. A syringe 2102 was used to inject water at a constant pressure of approximately 150 psi through a hemostatic valve 2104 connected to the outer catheter. Shortly after the water injection began, 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 lower) and a stroke length of approximately 20 mm (or more). After the axial reciprocating motion, visual inspection revealed that the lumen between the outer and inner catheters was substantially free of air bubbles.

[0350] control system

[0351] Figure 24 A schematic diagram illustrating an example of a control system 4000 is shown, which can be used to electronically control the systems and components described herein and / or perform the methods described herein. The control system 4000 can be configured to automatically adjust various motors, hub adapters, hubs, interventional devices, fluid dynamic components (e.g., valves, pumps, etc.), and / or any other components described herein in response to commands input by an operator (e.g., a physician). In response to operator commands, the control system 4000 can cause a series of responsive events to occur automatically.

[0352] In some embodiments, the control system 4000 may include one or more processors 4002. The one or more processors 4002 may be configured to automatically adjust various system components described herein in response to operator command input, for example, using one or more controls 4004 of the control system 4000. Figure 24 A single control element 4004 is shown. However, any suitable number of controls can be provided to correspond to the various functions of the system described herein. For example, in some embodiments, each interventional device may have its own unique control element 4004 or a set of controls 4004 that can control various functions of the interventional device (e.g., axial movement, rotational movement, fluid supply (e.g., saline, contrast agent, etc.), aspiration, etc.).

[0353] In some embodiments, one or more controls 4004 can control the pre-charge function of one or more interventional devices. For example, one or more controls 4004 can be operated to cause the interventional device to perform a pre-charge procedure, for example, by means of... Figures 20A to 20CAs described. For example, one or more controls 4004 can be operated to cause one or more interventional devices to move axially relative to one or more other interventional devices (e.g., by causing the corresponding hub and / or hub adapter to move axially). One or more controls 4004 can be operated to cause fluid to be introduced into the lumen of the interventional device, thereby pre-filling the interventional device.

[0354] In some implementations, one or more controls 4004 can be operated to cause the intervention device to perform a pre-charge procedure, for example, as by... Figures 21A to 21B As described. For example, one or more controls 4004 can be operated to cause one or more interventional devices to reciprocate relative to one or more other interventional devices (e.g., axial and / or rotational reciprocating movement) (e.g., by causing corresponding hubs and / or hub adapters to reciprocate). One or more controls 4004 can be operated to cause fluid to be introduced into the lumen macro of the interventional device, thereby pre-filling the interventional device (e.g., during relative reciprocating movement).

[0355] Processor 4002 may receive signals from one or more controllers 4004 and, in response, initiate corresponding actions in components of the system described herein. For example, processor 4002 may be configured to generate an output signal that causes the response action to be performed by the components described herein.

[0356] While robot-operated and manually operated interventional devices have been described above, these devices may be any combination of manually operated, robot-operated, or manually and robot-operated interventional devices, as those skilled in the art will understand in light of the disclosure herein.

[0357] The foregoing description outlines one specific implementation of a robot control system. A wide variety of different robot control system structures can be manufactured to support and axially advance and retract two, three, four, or more components to drive interventional devices for robot operation, as those skilled in the art will understand from the disclosure herein.

[0358] Although the interventional device driven by a drive station has been described above, other suitable robot drive systems or mechanisms can be used to drive the interventional device, as those skilled in the art will understand in light of the disclosure herein.

[0359] This article primarily describes various systems and methods in cases of neurovascular access or surgery (e.g., neurothrombosis resection). However, the catheters, systems (e.g., drive systems) and methods disclosed herein can be readily applied to any of a wide variety of other diagnostic and therapeutic applications throughout the body, particularly including endovascular procedures, such as those in the peripheral vascular system (e.g., deep vein thrombosis), the central vascular system (pulmonary embolism), and the coronary vascular system, as well as procedures in other hollow organs or tubular structures in the body.

[0360] Magnetic connection for torque transmission

[0361] In some implementations, magnets (e.g., neodymium magnets) can be used to transmit torque through a sterile barrier. For example, one or more magnets outside the sterile area can be connected to corresponding magnets inside the sterile area, such that rotation of one or more magnets outside the sterile area can cause rotation of one or more magnets inside the sterile area.

[0362] A torque transmission system can transmit torque from outside a sterile area (e.g., from a hub adapter) to within a sterile area (e.g., to the hub). Torque transmission systems may also be referred to as magnetic connections or rotary magnetic connections. In some embodiments, the hub adapter may be reusable (e.g., part of an asset device within the operating room), and the hub may be disposable. In some embodiments, the torque transmission system can facilitate the provision of torque to rotate interventional devices connected to the hub without requiring a motor and motor control board on a disposable hub, which can significantly reduce equipment and surgical costs. Furthermore, some embodiments of the torque transmission system disclosed herein eliminate the need for cable management for each hub, increasing simplicity and reducing system costs. In some embodiments, the torque transmission system can facilitate the provision of torque to rotate other instruments of a robotic surgical system (e.g., a robotic surgical system for neurovascular surgery). For example, a torque transmission system can be used to actuate one or more valves, as described herein. Instruments used in or for preparing for robotic surgical procedures (including interventional devices) may be referred to herein as surgical instruments.

[0363] Figure 25An embodiment of a portion of a robot drive system 6000 is shown, the robot drive system 6000 having a hub 6001, a hub adapter 6005, and a torque transmission system 6002, which can be used with any robot drive system embodiment disclosed herein to support and move instruments (e.g., interventional devices (e.g., catheters or guidewires)), the instruments being connected to the hub 6001 and configured to be inserted into the body during medical procedures. In some embodiments, the torque transmission system 6002 may include a drive-side torque transmission element and an instrument-side torque transmission element that is not physically in contact with the drive-side torque transmission element. The torque transmission element may also be referred to as a torque transmission unit or torque transmission device. Figures 26 to 30 Additional details of the torque transmission system 6002 are shown. In some embodiments, increasing the width of the magnet can linearly increase the magnitude of the magnetic connection force.

[0364] In some embodiments, the torque transmission system 6002 may include a drive-side torque transmission element and an instrument-side torque transmission element, the instrument-side torque transmission element being not connected to the drive-side torque transmission element via 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 stage (e.g., a wall) and a sterile barrier located on that section of the drive stage. The drive-side torque transmission element may be a non-sterile torque transmission element. The driven-side torque transmission element may be a sterile torque transmission element.

[0365] As described herein, although the implementation of the torque transmission system is not limited thereto, some implementations of the torque transmission system disclosed herein may have multiple magnets configured to provide magnetic connection force or magnetic shear force between the drive-side torque transmission element and the instrument-side torque transmission element to transmit torque from the drive-side torque transmission element to the instrument-side torque transmission element.

[0366] In any of the embodiments disclosed herein, the robot drive system 6000 and / or any component of the robot drive system 6000 may have any of the components, features, or other details of any other robot drive system embodiments disclosed herein, and vice versa. Hub 6001 may have any of the components, features, or other details of any other hub disclosed herein, and vice versa. Hub adapter 6005 may have any of the components, features, or other details of any other hub adapter disclosed herein, and vice versa.

[0367] Some embodiments of the torque transmission system 6002 may have an active torque element 6004 (also referred to herein as an active torque transmission element) and a passive torque element 6006 (also referred to herein as a passive torque transmission element). The active torque element 6004 may be a drive-side torque transmission element or a non-sterile-side torque transmission element. The passive torque element 6006 may be a drive-side torque transmission element or a sterile-side torque element.

[0368] Active torque element 6004 may be located on the non-sterile side of the sterile barrier, and passive torque element 6006 may be located on the sterile side of the sterile barrier. In some embodiments, passive torque element 6006 may be configured to be rotatably connected to a surgical instrument (e.g., any of the interventional devices described herein), such that rotation of passive torque element 6006 will generally cause rotation of the instrument connected to passive torque element 6006 (e.g., equal and simultaneous rotation), or at least cause rotation of the proximal portion of the instrument connected to passive torque element 6006 (e.g., provided that rotation of instrument I and passive torque element 6006 is not inhibited). In some embodiments, passive torque element 6006 may be configured to rotate due to the magnetic connection force between active torque element 6004 and passive torque element 6006 caused by rotation of active torque element 6004, as will be described in more detail herein.

[0369] The passive torque element 6006 may be part of, supported by, or otherwise connected to the hub 6001. The active torque element may be part of, supported by, or otherwise connected to the hub adapter 6005. A sterile barrier may be located between the passive torque element 6006 and the active torque element 6004, such that the active torque element 6004 is located on the non-sterile side of the sterile barrier, and the passive torque element 6006 is located on the sterile side of the sterile barrier. In some embodiments, there may be multiple torque transmission systems 6002, each of which is connected to or otherwise connected to a separate hub 6001.

[0370] In some embodiments, the electric motor 6030 may be connected to the active torque element 6004 below the sterile barrier. The electric motor 6030 can cause the active torque element 6004 to rotate, which in turn can cause the passive torque element 6006 to rotate due to the magnetic connection between the active torque element 6004 and the passive torque element 6006.

[0371] In some embodiments, hub 6001 may include a support housing 6080. As described herein, hub 6001 may be equipped with rollers that can be connected to support housing 6080. Hub adapter 6005 may include support housing 6081. As described herein, hub adapter 6005 may be equipped with rollers that can be connected to support housing 6081.

[0372] Hub 6001 can be configured to move along an axial direction, as described herein, to move passive torque element 6006 and any interventional device connected thereto. Robot drive system 6000 can be configured such that passive torque element 6006 can be rotated to move (e.g., rotate) surgical instruments (e.g., interventional devices) connected to hub 6001 without any puncture holes in the sterile barrier. In other words, this can be achieved without any wires or communication lines, drive components, structural components, or other tangible components connecting the hub to or passing through the sterile barrier on the non-sterile side of the sterile barrier.

[0373] In some embodiments, the interventional device connected to hub 6001 may be a guidewire, guiding catheter, surgical catheter, or entry or insertion catheter. In some embodiments, the surgical catheter may be an aspiration catheter, embolization deployment catheter, stent deployment catheter, flow shunt deployment catheter, diagnostic angiography catheter, stent retrieval device catheter, clot retrieval device, balloon catheter, catheter facilitating percutaneous valve repair or replacement, ablation catheter, or any other suitable or desired device.

[0374] Some embodiments of the torque transmission system 6002 can use magnets (e.g., but not limited to neodymium magnets) to transmit torque from the active torque element across a sterile barrier from the non-sterile side of the sterile barrier (e.g., the asset equipment side of the sterile barrier) to the sterile side of the sterile barrier (e.g., the disposable side) on hub 6001. In some embodiments, this can eliminate any penetration through the sterile barrier and eliminate the need for motors and motor control boards on disposable hubs or multiple hubs, which can significantly increase patient safety and reduce the cost of the procedure. Furthermore, the embodiments disclosed herein can eliminate or reduce the need for cable management for each hub, increasing the simplicity of the system.

[0375] In any embodiment of the torque transmission system 6002 disclosed herein, the magnets may be arranged in a circular or cylindrical configuration (e.g., around a central axis). For example, the active torque transmission element 6004 may include a configuration around a first central axis (e.g., Figure 26 Multiple magnets arranged in a circular or cylindrical shape (as shown by the central axis A6). The passive torque transmission element 6006 may include magnets arranged around a second central axis (e.g., Figure 27The central axis A7 shown represents a plurality of magnets arranged in a circular or cylindrical pattern. In some embodiments, the first central axis may be parallel to the second central axis. In some embodiments, the first and / or second central axes may be parallel to the central axis of the intervention device connected to the passive torque element.

[0376] 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 rotation of the active torque element 6004 on the non-sterile side of a sterile barrier will apply a rotational force or torque to the passive torque element 6006 and the surgical instrument (e.g., an interventional device) connected thereto. When the active torque element 6004 and the passive torque element 6006 are magnetically connected, this torque can cause the passive torque element 6006 and the surgical instrument connected thereto to rotate in response to the rotation of the active torque element 6004, provided that the passive torque element 6006 and / or the interventional device connected to the passive torque element 6006 are not prevented from rotating by external forces. In other words, in some implementations, when the active torque element 6004 and the passive torque element 6006 are magnetically connected (e.g., provided that any torque load on the passive torque element 6006 and / or the device connected to the passive torque element 6006 (if any) does not exceed the shear force generated by the magnetic field between the passive torque element 6006 and the active torque element 6004), the torque applied to the passive torque element 6006 by the active torque element 6004 can cause the passive torque element 6006 and any interventional device connected thereto to rotate.

[0377] In some embodiments, the rotation of the passive torque element 6006 can be delayed because the passive torque element 6006 can rotate in response to the rotation of the active torque element 6004, but after a short delay or hysteresis. In some embodiments, but not limited to this, such delay can be caused by the elasticity of the shear force between the active torque element 6004 and the passive torque element 6006 and / or by any force that inhibits the rotation of the passive torque element 6006 (e.g., frictional and / or inertial forces in the passive torque element 6006, frictional and / or inertial forces acting on surgical instruments (e.g., interventional devices) connected to the passive torque element 6006, or other torque-type forces). 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 that inhibits the rotation of the passive torque element 6006 and / or the surgical instrument. Due to the arrangement of the active torque element 6004 relative to the passive torque element 6006, in some embodiments, the passive torque element 6006 will rotate in the opposite direction to the rotation of the active torque element 6004, similar to a driven gear.

[0378] In any implementation, as described, a 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.

[0379] refer to Figure 25 In some embodiments, the active torque element 6004 may have a magnet element 6010 having a plurality of opposite poles, which are typically arranged in alternating positions such that a first magnet 6016 of the magnet element 6010 has a north (or positive) pole facing radially outward from the magnet element 6010, and a second magnet 6018 adjacent to the first magnet 6016 has a south (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 magnet element 6010, and so on in this alternating arrangement. In some embodiments, a plurality of first and second magnets 6016, 6018 may be supported between a first support 6012 and a second support 6014.

[0380] In some embodiments, the magnetic element 6010 may have eight or fewer (e.g., but not limited to 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, or 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 may have 12 or more (e.g., but not limited to 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 the instrument's rotational control, providing the surgeon with a finer level of control for rotating or torturing the instrument.

[0381] In any of the embodiments disclosed herein, the robot drive system 6000 may have two or more, three or more, four or more torque transmission systems, wherein each torque transmission system may have an active torque element 6004 and a passive torque element 6006. In any of the embodiments disclosed herein, the robot drive system 6000 may have two or more, three or more, four or more torque transmission systems, wherein any torque transmission system may have an active torque element 6004 and / or a passive torque element 6006 that differs from another torque transmission system in terms of the number of magnets, the type of magnets, the size of the magnets, and the active torque element and / or passive torque element 6006.

[0382] In some embodiments, the first and second magnets 6016, 6018 may have an elongated cubic shape. The magnet element 6010 may have a space 6019 between each adjacent magnet. In some embodiments, each of the first and second magnets 6016, 6018 may have a wedge or arc segment shape, such that each of the first and second magnets 6016, 6018 can fit together tightly to minimize or eliminate all gaps between the first and second magnets 6016, 6018.

[0383] like Figure 26 As shown, the first and second support members 6012, 6014 may have multiple grooves or recesses 6015 configured to receive and support the first and second magnets 6016, 6018. The first and second support members 6012, 6014 may be connected together, or may be integral or made of a single piece of material. In some embodiments, as shown, the first and second support members 6012, 6014 may have a circular or disc-shaped shape. The magnet element 6010 may be axially and rotatably connected to a drive motor 6030. The drive motor 6030 may be configured to rotate the magnet element 6010 in response to user input, for example, but not limited to, when the user desires to rotate a catheter, guidewire, or any other desired interventional device (or other surgical instrument) connected to the passive torque element 6006. In some embodiments, the magnet may be connected to the first and / or second support members or other components of the magnet element by screws, pins, adhesives, grooves, recesses, and / or other mechanical fasteners.

[0384] Some embodiments of the magnet may have features configured to lock or secure with complementary features on the first and / or second support members. For example, but not limited to, some embodiments of the magnet may have a T-shaped groove or other locking groove or channel in its radially inward portion, the T-shaped groove or other locking groove or channel being configured to receive and / or engage complementary protrusions or features on the radially outward portion of the first and / or second support members. Similarly, for example, but not limited to, some embodiments of the magnet may have a T-shaped protrusion in its radially inward portion, the T-shaped protrusion being configured to slide into and engage with a T-shaped groove on the radially outward surface of the first and / or second support member. In some embodiments, each magnet may have a groove (e.g., a T-groove) on one side and complementary protrusions (e.g., T-shaped protrusions) on the opposite side surface, such that when in an assembled state or position, the magnets are configured to engage together during assembly and secure to each other against radial movement.

[0385] like Figure 26 As shown, some embodiments of the magnet element 6010 may have an opening 6017 passing through it. The opening 6017 may be configured to receive the shaft 6031 of the motor 6030 passing through it (e.g., ...). Figure 25 (As shown). The opening 6017 may have a flat surface for rotation with the shaft 6031 or to prevent the shaft 6031 from rotating relative to the magnet element 6010 in the assembled state.

[0386] In some embodiments, the magnet element 6010 may be formed of a single magnet having a plurality of alternating poles or a plurality of portions, each of which has a north or south pole, and the plurality of portions are arranged in an alternating manner. For example, but not limited to, the magnet element 6010 may be formed of a single magnet having 10 alternating poles or alternating polarity regions (i.e., 5 north poles and 5 south poles arranged alternately), or 12 or more alternating poles or alternating polarity regions (i.e., 6 north poles and 6 south poles arranged alternately), or 14 or more alternating poles or alternating polarity regions (i.e., 7 north poles and 7 south poles arranged alternately), or 16 or more alternating poles or alternating polarity regions (i.e., 8 north poles and 8 south poles arranged alternately), or 18 or more alternating poles or alternating polarity regions (i.e., 9 north poles and 9 south poles arranged alternately), or 20, 22, or 24 or more alternating poles.

[0387] Similarly, in some implementation schemes, reference is made to... Figure 25The passive torque element 6006 may have a magnet element 6050, which may have multiple north and south poles. These multiple north and south poles are typically arranged alternately, such that a first magnet 6056 of the magnet element 6050 has a north (or positive) pole facing radially outward from the magnet element 6050, and a second magnet 6058 adjacent to the first magnet 6056 has a south (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.

[0388] Compared to any embodiment of the magnet element 6010 described above, any embodiment of the magnet element 6050 can be similarly configured, for example, but not limited to, any embodiment of the magnet element 6050 can have wedge-shaped or truncated disc-shaped first and second magnets (e.g., as by means of...). Figures 36 to 41 The first and second magnets 6116, 6118 of the illustrated magnet element 6110 are described. Any embodiment of the magnet element 6050 may have any arrangement and number of magnets as described above for the magnet element 6010.

[0389] In some embodiments, the first and second magnets 6056, 6058 may have an elongated cubic shape, such as Figure 29 and Figure 30 As shown. The magnet element 6050 may have a space or opening 6059 between each adjacent magnet. In some embodiments, each of the first and second magnets 6056, 6058 may have a wedge or arc segment shape, such that each of the first and second magnets 6056, 6058 can fit together tightly to minimize or eliminate all gaps between the first and second magnets 6056, 6058.

[0390] In some embodiments, the magnetic element 6050 may have eight or fewer (e.g., but not limited to 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., but not limited to twelve, fourteen, sixteen, eighteen, or twenty or more) different poles (e.g., alternating poles) or magnets 6056, 6058.

[0391] In some embodiments, a plurality of first and second magnets 6056, 6058 may be supported between a first support 6052 and a second support 6054. The first and second supports 6052, 6054 may have a plurality of grooves or recesses 6055 configured to receive and support the first and second magnets 6056, 6058. The first and second supports 6052, 6054 may be connected together, or may be integral or made of a single piece of material. In some embodiments, as shown, the first and second supports 6052, 6054 may have a circular or disk-shaped shape. A magnet element 6050 may be axially and rotatably connected to an instrument connection element 6070, which may be configured to receive an interventional device and rotate the interventional device in response to rotation of the magnet element 6050.

[0392] like Figure 26 As shown, some embodiments of the magnet element 6050 may have a hub assembly 6057 configured to be at least partially received within an opening 6059 in the second support 6054 and an opening 6061 in the first support 6052. The opening 6059 may axially pass through the second support 6054. The opening 6061 may axially pass through the first support 6052. The hub assembly 6057 may be fixedly connected to the first and second supports 6052, 6054. In some embodiments, the first support 6052, the second support 6054, and the hub assembly 6057 may be manufactured as separate, independent components. In some embodiments, the first support 6052, the second support 6054, and the hub assembly 6057, along with a plurality of recesses or recesses 6055 and openings 6059, may be manufactured as a combined, single, integral component.

[0393] The instrument connector 6063 may have a cylindrical body portion 6065 that can be received within an opening 6067 axially passing through a hub assembly 6057. In some embodiments, the hub assembly 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 connected to the hub assembly 6057 and biased to disengage from the hub assembly 6057 by friction or interference fit. In some embodiments, the cylindrical body portion 6065 may be a locking Luer assembly for a guidewire. In some embodiments, the hub assembly 6057 may include a shoulder for bearing straddling.

[0394] The opening 6071 may extend axially through the instrument connector 6063. The instrument connector 6063 may be configured to selectively fasten and retract around the outer surface of a surgical instrument (e.g., an interventional device (e.g., a guidewire or catheter)) extending through the instrument connector 6063 to prevent axial movement of the instrument relative to the instrument connector 6063.

[0395] In some embodiments, the magnet element 6050 may be formed of a single magnet having a plurality of alternating poles or a plurality of portions, each of which has a north or south pole, and the plurality of portions are arranged in an alternating manner. For example, but not limited to, the magnet element 6050 may be formed of a single magnet having a region of 10 alternating poles or alternating polarities (i.e., 5 north poles and 5 south poles arranged alternately), or a region of more than 10 alternating poles or alternating polarities, or a region of 12 alternating poles or alternating polarities (i.e., 6 north poles and 6 south poles arranged alternately), or a region of more than 12 alternating poles or alternating polarities. In some embodiments, the magnet element 6050 may be formed from a single magnet having a region with 16 alternating poles or alternating polarities (i.e., 8 north poles and 8 south poles arranged alternately), or more than 16 alternating poles or alternating polarities, or a region with 18 alternating poles or alternating polarities (i.e., 9 north poles and 9 south poles arranged alternately), or more than 18 alternating poles or alternating polarities.

[0396] In some embodiments, the magnet element 6050 of the passive torque element 6006 may have a larger radius than the magnet element 6010 of the active torque element 6004. This can increase the torque applied to the interventional device connected to the passive torque element 6006, and also increase the rotational resolution of the interventional device connected to the passive torque element 6006.

[0397] The passive torque element 6006 can be supported by or connected to a support housing 6080, which can be configured in any desired direction (e.g., but not limited to, any axial direction parallel to the centerline axis of the intervention device connected to the passive torque element 6006). Figure 31 The support housing 6080 may have one or more bearings, slide plates, wheels, or other features to facilitate movement of the support housing in at least the axial direction.

[0398] 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, but not limited to, any other embodiment using magnets disclosed herein. Any such component can be combined with any of the components of the passive torque element 6006 in any combination to enable such axial movement of the support housing 6080.

[0399] In some embodiments, the magnet may be a neodymium magnet. Any support components to which the magnet is attached may be made of any suitable or desired plastic, metallic, or other material. In some embodiments, the first support 6012, the second support 6014, the first support 6052, and / or the second support 6054 may be molded plastic or metal, or may be 3D printed plastic or metal.

[0400] In some embodiments, as described, the torque element may use alternating polarity neodymium magnets arranged in a circular pattern. In some embodiments, the torque element (e.g., an active torque element or a passive torque element) may have 10 magnets arranged in a circular pattern, or any number of magnets disclosed herein or desired. The circle of any embodiment of the torque element disclosed herein may have an outer diameter of 1 inch, or about 1 inch, or 0.5 inches to 2 inches, or any value disclosed in the foregoing range. In some embodiments, the passive torque element may have 18 magnets arranged in a circular pattern. The circle may have an outer diameter of 1.48 inches, or about 1.5 inches, or 0.75 inches to 2.5 inches, or any value disclosed in the foregoing range. In some embodiments, the passive torque element may have a larger outer diameter than the active torque element compared to a smaller passive torque element to produce a gear reduction that increases the torque applied to the instrument. In some implementations, a larger diameter of the passive torque element can also cause the magnetic element of the passive torque element to be closer to the sterile barrier.

[0401] In some embodiments, the distance between the active torque element and the passive torque element can be 0 to 0.35 inches, or about 0.35 inches, or greater than 0.35 inches. The magnetic field strength between the active and passive torque elements will decrease as the space between them increases. The magnetic field strength decreases with the square of the distance, so after a certain distance, the transmitted torque decreases exponentially. At a barrier thickness of 0.185 inches, in some embodiments, the torque transmission system 6002 can transmit a peak torque of 46 mNm or about 46 mNm. In some embodiments, the guidewire and insertion catheter will be subjected to a torque force of 10 mNm or up to 20 mNm. Therefore, in some embodiments, the torque transmission system 6002 can be configured to transmit torque from 0 to 25 mNm or about 25 mNm, or from 0 to 20 mNm or about 20 mNm, or transmit a peak torque of 20 mNm or about 20 mNm, or 25 mNm or about 25 mNm, or 30 mNm or about 30 mNm.

[0402] Figure 31 This is a perspective view of an embodiment of a passive torque element 6106 connected to an interventional device I, which may be any of the interventional devices described herein. In any embodiment disclosed herein, the passive torque element 6106 may have any of the components, features, or other details of any other passive torque element embodiments disclosed herein, including but not limited to any embodiment of the passive torque element 6006 disclosed herein. Furthermore, any embodiment of the passive torque element 6106 may be configured to receive and connect any desired interventional device I.

[0403] For example, but not limited to, the passive torque element 6106 may have a magnet element 6150 having a plurality of opposite poles, which are typically arranged in an alternating manner such that a first magnet 6156 of the magnet element 6150 has a north (or positive) pole facing radially outward from the magnet element 6150, and a second magnet 6158 adjacent to the first magnet 6156 has a south (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 magnet element 6150, and so on in this alternating arrangement.

[0404] In some embodiments, the first and second magnets 6156, 6158 may have an elongated cubic shape, such as Figure 33As shown. Magnet element 6150 may have a space 6159 between each adjacent magnet. In some embodiments, each of the first magnet 6156 and the second magnet 6158 may have a wedge or arc segment shape, such that each of the first magnet 6156 and the second magnet 6158 can fit together tightly to minimize or eliminate all or excessive spacing between the first magnet 6156 and the second magnet 6158.

[0405] In some embodiments, the magnetic element 6150 may have eight or fewer (e.g., but not limited to 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., but not limited to twelve, fourteen, sixteen, eighteen, or twenty or more) different poles or magnets 6156, 6158.

[0406] The instrument connector 6163 may have a cylindrical body portion 6165, which may be received within an opening axially passing through the hub assembly 6157. The opening may extend axially through the instrument connector 6163. The instrument connector 6163 may be configured to selectively fasten and retract around the outer surface of an interventional device (e.g., a guidewire or catheter) extending through the instrument connector 6163 to prevent axial movement of the instrument relative to the instrument connector 6163.

[0407] like Figure 31 As shown, the instrument connector 6163 and / or the magnetic element 6150 can be connected to a hemostatic valve, such as a rotary hemostatic valve (RHV) 6160. RHV 6160 may include a fluid port 6162 that is in fluid communication with a fluid dynamics system for delivering fluid (e.g., saline and / or contrast agent) to instrument I and / or for aspirating fluid from instrument I. RHV 6160 may include a handle or lever 6164 that can be manually actuated to control RHV 6160. In other embodiments, RHV 6160 may be robotically actuated.

[0408] The RHV 6160 can be configured to receive a more proximal interventional device. The RHV 6160 is actuable between various states to allow and / or restrict movement of the interventional device through it and to allow and / or prevent fluid flow through it. For example, the RHV 6160 can be actuated between a first fully open state, a second partially open state (low sealing force state) (for sealing around the interventional device but allowing sliding movement of the interventional device), a third state (for sealing around the interventional device for high-pressure management), and a fourth fully closed state (with no interventional device extending through it).

[0409] In some embodiments, a plurality of first and second magnets 6156, 6158 may be supported between a first support 6152 and a second support 6154. The first and second supports 6152, 6154 may have a plurality of grooves or recesses 6155 configured to receive and support the first and second magnets 6156, 6158. The first and second supports 6152, 6154 may be connected together, or may be integral or made of a single piece of material. In some embodiments, as shown, the first and second supports 6152, 6154 may have a circular or disk-shaped shape. A magnet element 6150 may be axially and rotatably connected to an instrument connection element 6170, which may be configured to receive a surgical instrument I (e.g., an interventional device) and rotate the surgical instrument I in response to rotation of the magnet element 6150.

[0410] Figures 34 to 35 Alternative embodiments of the robot drive system 6000a are shown, wherein both the active torque element 6004 and the passive torque element 6006 are located on the sterile side (e.g., the disposable side). As shown, in some embodiments, the active torque element 6004 may be connected to the hub 6001. For example, the active torque element 6004 and / or the electric motor 6030 may be mounted above the passive torque element 6006.

[0411] Figures 36 to 41Another example embodiment of the magnet element 6110 is shown, the magnet element 6110 having a plurality of first magnets 6116 and second magnets 6118, the first magnets 6116 and second magnets 6118 having opposing outward-facing poles and arranged alternately such that the first magnets 6116 of the magnet element 6110 have a north (or positive) pole facing radially outward from the magnet element 6110, and the second magnets 6118 adjacent to the first magnets 6116 have a south (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 magnet element 6110, and so on in this alternating arrangement. In some embodiments, the plurality of first magnets 6116 and second magnets 6118 may be supported by a first support member 6112. In some embodiments, the cross-sectional shape of the first magnets 6116 and second magnets 6118 may be disc-shaped or have a truncated disc shape. Any embodiment of the magnet element 6110 can be used with any embodiment of the robot drive system 6000 disclosed herein.

[0412] In some embodiments, a fastener 6119 (e.g., a screw) may be used to connect each of the first magnet 6116 and the second magnet 6118 to the first support 6112. The fastener 6119 may be advanced through an opening 6122 (which extends longitudinally through each of the first and second magnets 6116, 6118) and through each of the openings 6124 in the first support 6112. In some embodiments, the opening 6124 may be threaded. In some embodiments, a recessed opening 6123 may be formed coaxially with the opening 6122, such that the head of the fastener 6119 can be embedded within each of the first and second magnets 6116, 6118. In some embodiments, a recessed opening (e.g., a recess 6126) may be formed coaxially with each opening 6124, such that a nut can be positioned and embedded within the first support 6112 for each fastener 6119. In some embodiments, the first support 6112 may have a central portion 6130 extending axially away from the flange portion 6132. The central portion 6130 may provide a support surface for the radially inward-facing surface of each of the first and second magnets. The central portion 6130 may be coaxial with the opening 6140 extending through the magnet element 6110.

[0413] like Figure 41 As shown, in some embodiments, the arc-shaped magnets 6116 and 6118 can have a total length L1 of 0.375 in, or approximately 0.375 inches. For example... Figure 39As shown, the arcuate segments may have sidewalls separated by an angle A of 29 degrees or approximately 29 degrees. The inner radius R1 of the arcuate segment magnets 6116, 6118 may be 0.250 in, or approximately 0.250 in, and the outer radius R2 of the arcuate segment magnets 6116, 6118 may be 0.50 in, or approximately 0.50 in. The diameter D1 of the opening 6122 extending through the arcuate segment magnets 6116, 6118 may 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 foregoing values ​​may be increased or decreased by 10%, or increased or decreased by 20%, or increased or decreased by 30%.

[0414] Figures 42A to 43P Additional embodiments of a torque transmission system in the form of a magnetic connection with magnets (e.g., neodymium magnets) are shown, which are used to transmit torque across a sterile barrier from an asset device (e.g., a hub adapter) to a disposable side of the surgical robot (e.g., to a hub, also referred to herein as a small circular element). As previously described, this can have the advantage of eliminating the need for a motor and motor control board on a disposable hub, significantly reducing the cost of the device and the surgery. Furthermore, some embodiments of the magnetic connectors disclosed herein eliminate the need for cable management for each hub, increasing simplicity and reducing the cost of the system.

[0415] Figures 42A to 43P It shows a butted shaft configuration (face magnet) instead of as shown Figures 25 to 41 The parallel-axis configuration shown is an edge magnet. Magnetic torque coupling transmits rotational power without mechanical attachments. The absence of mechanical attachments (such as drive shafts) allows torque to be transmitted across sterile barriers without the need for moving components. While magnetic coupling significantly simplifies workflows, it increases design complexity, and torque transmission is not yet fully understood. Empirical testing will be used to quantify the impact of magnetic torque and the following factors.

[0416] Figures 42A to 42B An embodiment of a torque transmission system 6500 is shown, which can be configured to transmit torque force through a sterile barrier (in...). Figure 42A(S is used to represent the torque). In some embodiments, the torque transmission system 6500 may include an active torque element 6502 and a passive torque element 6504, the active torque element 6502 being configured to be located on the non-sterile side of the sterile barrier (e.g., the asset equipment side), and the passive torque element 6504 being configured to be located on the sterile side of the sterile barrier (e.g., the disposable equipment side).

[0417] In some implementations, the active torque element 6502 may include a portion surrounding a central axis (in... Figure 42B Multiple magnets are arranged along axis A9. These magnets may include one or more first magnets 6514 and one or more second magnets 6516. One or more first magnets 6514 may have their axial faces facing the north or positive pole of the passive torque element 6504. One or more second magnets 6516 may have their axial faces facing the south or negative pole of the passive torque element 6504. Magnets 6514 and 6516 may be disk magnets. In some embodiments, the multiple magnets of the active torque element 6502 may be arranged in a planar arrangement on a plane parallel or substantially parallel to the sterile barrier.

[0418] 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 an axially facing south or negative pole of the active torque element 6502. The one or more second magnets 6556 may include an axially facing north or positive pole of the active torque element 6502. 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 arrangement on a plane parallel or substantially parallel to a sterile barrier.

[0419] 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. Rotation of the plurality of magnets of the active torque element 6502 about the central axis of the plurality of magnets of the active torque element 6502 can cause a corresponding rotation of the plurality of magnets of the passive torque element 6504 about the central axis of the plurality of magnets of the passive torque element 6504.

[0420] In some embodiments, the central axes of the plurality of magnets of the active torque element 6502 may be coaxial or parallel to the central axes of the plurality of magnets of the passive torque element 6504. In some embodiments, the central axes of the plurality of magnets of the active torque element 6502 and / or the central axes of the plurality of magnets of the passive torque element 6504 may be transverse to (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 transmission system 6500 are connected.

[0421] In some embodiments, the active torque element may include a shaft 6512 configured about a longitudinal centerline axis (in...) Figure 42B The axis 6512 (represented by A10) rotates. The longitudinal centerline of the shaft 6512 may be coaxial with the central axes (e.g., axis A9) of the plurality of magnets of the active torque element 6502. One or more first magnets 6514 and one or more second magnets 6516 may be connected to the shaft 6512. In some embodiments, the active torque element 6502 may include a magnet support element 6540 located at the distal end of the shaft 6512 of the active torque element 6502 (e.g., connected to or integrally formed with the distal end of the shaft 6512 of the active torque element 6502).

[0422] In some embodiments, the passive torque element 6504 may include a shaft 6522 configured to rotate about a longitudinal centerline axis. The longitudinal centerline axis of the shaft 6522 may be coaxial with the central axes of a plurality of magnets of the passive torque element 6504. One or more first magnets 6554 and one or more second magnets 6556 may be connected to the shaft 6522. In some embodiments, the passive torque element 6504 may include a magnet support element 6550 located at the distal end of the shaft 6522 of the passive torque element 6504 (e.g., connected to or integrally formed with the distal end of the shaft 6522 of the passive torque element 6504).

[0423] In some embodiments, the shaft 6512 of the active torque element 6502 can be rotated (e.g., by a motor) to cause rotation of the magnet support element 6540 and / or the plurality of magnets of the active torque element 6502. Rotation of the plurality of magnets of the active torque element 6502 can cause rotation of the plurality of magnets of the passive torque element 6504. Rotation of the plurality of magnets of the passive torque element 6504 and / or the magnet support element 6550 can cause rotation of the shaft 6522.

[0424] The plurality of magnets of the passive torque element 6504, the magnet support element 6550 and / or the shaft 6522 can be connected to surgical instruments (e.g., interventional devices, valves, etc.) (e.g., directly or indirectly) such that rotation of the plurality of magnets of the passive torque element 6504 causes corresponding movement of the surgical instruments (e.g., rotation of the interventional device, opening and / or closing of the valve, etc.).

[0425] refer to Figures 43A to 43P This document also discloses embodiments of a torque transmission system 7000, which can be configured to transmit torque force through a sterile barrier (represented by S in some figures). In some embodiments, the torque transmission system 7000 may include an active torque element 7002 and a passive torque element 7004, the active torque element 7002 being configured to be located on the non-sterile side of the sterile barrier S (e.g., the asset / equipment side), and the passive torque element 7004 being configured to be located on the sterile side of the sterile barrier S (e.g., the disposable equipment side).

[0426] 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 about a longitudinal centerline axis (in...) Figure 43E The first magnet 7014 is 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 configured to rotate about a longitudinal centerline axis of the shaft 7022, and the passive torque element 7004 may include at least a first magnet 7024 directly or indirectly connected to the shaft 7022 of the passive torque element 7004.

[0427] The torque transmission 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 transmission 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, rotation of the shaft 7012 of the active torque element 7002 about the axis of the shaft 7012 will cause a torque to be applied to the shaft 7022 of the passive torque element 7004, said torque biasing the passive torque element 7004 about the axis of the shaft 7022 (by...). Figure 43AIn this context, A12 indicates rotation. For example, rotation of shaft 7012 can cause movement of the first magnet 7014 of the active torque element 7002 (e.g., about the axis of shaft 7012 or about the central axis of the plurality of 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 (e.g., about the axis of shaft 7022 or about the central axis of the plurality of magnets of the passive torque element 7004). Movement of the first magnet 7024 can cause rotation of shaft 7022 about its axis.

[0428] Compared to the first magnet 7014 of the active torque element 7002, the first magnet 7024 of the passive torque element 7004 may have the opposite polarity, such 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 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, and the passive torque element 7004 may further include a second magnet 7026 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 transmission system 7000 may be configured such that the second magnet 7026 of the passive torque element 7004 can be magnetically connected to the second magnet 7016 of the active torque element 7002. Compared to the first magnet 7014 of the active torque element 7002, the second magnet 7016 of the active torque element 7002 may have the opposite polarity, and compared to the first magnet 7024 of the passive torque element 7004, the second magnet 7026 of the passive torque element 7004 may have the opposite polarity, 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.

[0429] In any of the embodiments disclosed herein, the active torque element 7002 may include a plurality of magnets (e.g., but not limited to, three or more magnets), each said magnet being radially spaced apart from each other and radially spaced apart 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 disk-shaped, having a first polarity on the top side of the disk and an opposite polarity on the bottom side of the disk. Similarly, the passive torque element 7004 may include a plurality of magnets, each said magnet being radially spaced apart from each other and radially spaced apart 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 disk-shaped, having a first polarity on the top side of the disk and an opposite polarity on the bottom side of the disk. Each of the plurality of magnets of the active torque element 7002 is configured to be alignable and magnetically connected to each of the plurality of magnets of the passive torque element 7004.

[0430] In some embodiments, the active torque element 7002 may further include a second magnet 7016 and a third magnet, both spaced apart from each other and from the first magnet 7014 of the active torque element 7002 and from the centerline axis of the shaft 7012 of the active torque element 7002. Similarly, the passive torque element 7004 may also include a second magnet 7026 and a third magnet, both spaced apart from each other and from the first magnet 7024 of the passive torque element 7004 and from the centerline axis of the shaft 7022 of the passive torque element 7004, wherein the torque transmission system 7000 may be configured such that the second magnet 7026 of the passive torque element 7004 may be aligned and / or magnetically connected to the second magnet 7016 of the active torque element 7002, and the third magnet of the passive torque element 7004 may be aligned and / or magnetically connected to the third magnet of the active torque element 7002.

[0431] In some embodiments, the active torque element 7002 may further include a fourth magnet spaced apart from the first magnets 7014, 7016, and 3 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 also include a fourth magnet spaced apart from the first magnets 7024, 7026, and 3 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 transmission system 7000 may be configured such that the fourth magnet of the passive torque element 7004 is magnetically connected to the fourth magnet of the active torque element 7002. Figures 42A to 42BThe diagram shows an implementation scheme for a torque transmission system having an active torque element with four magnets and a passive torque element with four magnets.

[0432] In any of the embodiments disclosed herein, the active torque element 7002 may include a magnet support element 7040 located at the distal end of the shaft 7012 of the active torque element 7002 (e.g., connected to or integrally formed thereto). The magnet support element 7040 of the active torque element 7002 may be configured to support a plurality of magnets in a radially plane arranged about a central axis of a 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 located at the distal end of the shaft 7022 of the passive torque element 7004 (e.g., connected to or integrally formed thereto). The magnet support element 7050 of the passive torque element 7004 may be configured to support a plurality of magnets in a radially plane arranged about a central axis of a plurality of magnets (which may 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 connected to each of the plurality of magnets of the passive torque element 7004.

[0433] In some embodiments, the magnet support element 7040 of the active torque element 7002 may include a disc-shaped body 7042 and a plurality of recesses 7044 formed in the disc-shaped body 7042, wherein each of the plurality of recesses 7044 formed in the disc-shaped body 7042 of the active torque element 7002 may be configured to receive each of the magnets of the active torque element 7002 therein. 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.

[0434] like Figure 43EAs shown, in some embodiments, the magnet support element 7040 of the active torque element 7002 may include a disk-shaped body 7042. The disk-shaped body 7042 may include a first recess 7044a and a second recess 7044b formed therein. The first recess 7044a is configured to receive a first magnet 7014 of the active torque element 7002, and the second recess 7044b is configured to receive a second magnet 7016 of the active torque element 7002. The disk-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, such that the disk-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.

[0435] Similarly, the magnet support element 7050 of the passive torque element 7004 may have a disc-shaped body 7052 and a plurality of recesses 7054 formed in the disc-shaped body 7052, wherein each of the plurality of recesses 7054 formed in the disc-shaped body 7052 of the passive torque element 7004 may be configured to receive each of the magnets of the passive torque element 7004 therein. The disc-shaped body 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 of the embodiments disclosed herein, the magnet support element 7050 of the passive torque element 7004 may include a disk-shaped body 7052, the disk-shaped body 7052 including a first recess 7054 and a second recess 7054 formed therein, the first recess 7054 being configured to receive a first magnet 7024 of the passive torque element 7004, and the second recess 7054 being configured to receive a second magnet 7026 of the passive torque element 7004. The disk-shaped body 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, such that the disk-shaped 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.

[0436] In some embodiments, the first magnet 7014 (and any other magnet) of the active torque element 7002 may be spaced apart from the axis of the shaft 7012 of the active torque element 7002, such that the center of the first magnet 7014 (and any other magnet) of the active torque element 7002 is eccentric to the axis of the shaft 7012 of the active torque element 7002, and the first magnet 7014 (and any other magnet) of the active torque element 7002 is configured to rotate in a track about the axis of the shaft 7012 of the active torque element 7002. Similarly, the first magnet 7024 (and any other magnet) of the passive torque element 7004 may be spaced apart 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 magnet) of the passive torque element 7004 is eccentric to the axis of the shaft 7022 of the passive torque element 7004, and such that the first magnet 7024 (and any other magnet) of the passive torque element 7004 is configured to rotate in a track about the axis of the shaft 7022 of the passive torque element 7004. In any of the embodiments disclosed herein, the active torque element 7002 and the passive torque element 7004 may each include only two magnets connected to the shaft 7012 of the active torque element 7002 and the passive torque element 7004 respectively, or only three magnets connected to the shaft 7012 of the active torque element 7002 and the passive torque element 7004 respectively, or only four magnets connected to the shaft 7012 of the active torque element 7002 and the passive torque element 7004 respectively.

[0437] In some embodiments, the active torque element 7002 may be configured to be located on the non-sterile side of the sterile barrier (e.g., the asset / equipment side), and the passive torque element 7004 may be configured to be located on the sterile side of the sterile barrier (e.g., the disposable equipment side). Furthermore, in any of the embodiments disclosed herein, the torque transmission system 7000 may be configured for use in a surgical robot drive system as described herein. For example, the active torque element 7002 may be connected to a hub adapter, and the passive torque element 7004 may be connected to the hub of the robot drive system.

[0438] In some embodiments, the active torque element 7002 may include a motor 7070 connected to the shaft 7012 of the active torque element 7002 and configured to selectively apply a torque force to the shaft 7012 of the active torque element 7002 to cause rotation of the shaft 7012. In some embodiments, the motor 7070 may be a servo motor. The torque transmission system 7000 may include a controller 7072, such as... Figure 43PThe controller 7072 (also referred to herein as a control module or control circuit) is in electrical communication with the motor 7070 of the active torque element 7002. 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.

[0439] In some embodiments, the active torque element 7002 may further include a driven disk 7078 between the shaft 7012 and the motor 7070. The driven disk 7078 may be configured to limit the magnitude of the torque transmitted from the motor 7070 to the shaft 7012. Some embodiments of the active torque element 7002 may also include a ball bearing 7080 surrounding a portion of the shaft 7012 of the active torque element 7002, and the passive torque element 7004 may also include a ball bearing 7080 surrounding a portion of the shaft 7022 of the passive torque element 7004.

[0440] like Figure 43H and Figure 43I As shown, 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., the housing of the hub adapter), which can be configured to translate at least axially. The housing 7082 can be in the form of a support plate.

[0441] Similarly, the passive torque element 7004 may be connected to or supported by the hub 7001. In some embodiments, the passive torque element 7004 may be connected to or supported by a housing 7084 and / or a support plate or housing 7085 (e.g., the housing 7084 and / or support plate or housing 7085 of the hub), or may be enclosed or partially enclosed within a housing 7084 and / or housing 7085, which may be configured to at least translate axially.

[0442] In some embodiments, the hub adapter 7005 may be configured to connect to a plurality of active torque elements 7002 (e.g., via housing 7082), including two, three, four, five, or more than five active torque elements 7002. In some embodiments, the hub 7001 may be configured to connect to a plurality of passive torque elements 7004 (e.g., via housing 7084 and / or housing 7085), including two, three, four, five, or more than five passive torque elements 7004.

[0443] In some implementation schemes, such as Figure 43MAs shown, the support plate or housing 7082 may include a plurality of recesses 7093, each of which is configured to receive a magnet support element 7040 of the active torque element 7002 therein. The dimensions of each of the plurality of recesses 7093 may be slightly larger than that of the magnet support element 7040, such that the magnet support element 7040 can rotate freely within the recesses 7093.

[0444] Similarly, such as Figure 430 As shown, in some embodiments, the support plate or housing 7085 of the passive torque element 7004 may include a plurality of recesses 7095, each of said recesses 7095 being configured to receive a magnet support element 7050 of the passive torque element 7004 therein. The respective dimensions of the plurality of recesses 7095 may be slightly larger than the magnet support element 7050, such that the magnet support element 7050 can rotate freely within the recess 7095. Note that in some figures, not all of the passive torque elements 7004 are shown for clarity.

[0445] In some implementation schemes, such as Figure 43M As shown, 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, such as Figure 430 As shown, the housing 7085 may have a plurality of rollers 7091 (e.g., connected to the housing 7085) configured to roll along a sterile barrier.

[0446] In some implementation schemes, such as Figures 43N to 43P As shown, 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 is configured to engage with and rotate a second gear 7092 when the shaft 7022 of the passive torque element 7004 rotates. In some embodiments, the first gear 7090 and the second gear 7092 may be equal-diameter bevel gears (also known as conical gears). In some embodiments, the second gear 7092 may be rotatably and axially connected to a surgical instrument. Figures 43N to 43P As shown, the second gear 7092 can be connected to an interventional device 7096 (e.g., a guidewire or catheter described herein). The interventional device 7096 can be configured to rotate when the second gear 7092 rotates. In some embodiments, the interventional device 7096 can be a guidewire, an insertion or access catheter, a guiding catheter, or a surgical catheter. In some embodiments, the surgical catheter can be an aspiration catheter, an embolization deployment catheter, a stent deployment catheter, a flow shunt deployment catheter, a diagnostic angiography catheter, a stent retrieval catheter, a clot retrieval device, a balloon catheter, a catheter facilitating percutaneous flap repair or replacement, an ablation catheter, or any other suitable or desired device.

[0447] Despite Figure 43N and Figure 430 The diagram shows a passive torque element 7004 for rotating an interventional device, but it is conceivable that the passive torque element 7004 could be used to control various surgical instruments, including additional components and / or functions such as hub 7001. For example, one or more passive torque elements 7004 can be connected to a valve. The passive torque element 7004 can be configured to rotate the valve between various states (e.g., open and closed positions). The valve can be a rotary hemostatic valve (RHV) or a plug valve. In some embodiments, the passive torque element 7004 can be configured to actuate the RHV between various states to allow and / or restrict movement of the interventional device therethrough, and to allow and / or prevent fluid flow through it. For example, the RHV can be actuated between a first fully open state, a second partially open (low sealing force state) (for sealing around the interventional device but allowing sliding movement of the interventional device), a third state (for sealing around the interventional device for high pressure management), and a fourth fully closed state (without any interventional device extending through it).

[0448] In some embodiments, the passive torque element 7004 may be configured to be connected to a guidewire, and the passive torque element 7004 or another passive torque element 7004 may be configured to selectively deflect at least a distal portion of the guidewire as the passive torque element 7004 rotates. In some embodiments, the passive torque element 7004 may be configured to be connected to a catheter, and the passive torque element 7004 or another passive torque element 7004 may be configured to selectively deflect at least a distal portion of the catheter as the passive torque element 7004 rotates. In some embodiments, the passive torque element 7004 may be configured to selectively actuate the function of the interventional device, such as aspiration, fluid delivery, etc.

[0449] As described herein, hub 7001 and hub adapter 7005 may be part of a robot drive system, which may include combinations of multiple hubs 7001 and hub adapters 7005 for connection to different intervention devices, as described herein. For example, one or more hubs of intervention device assembly 2900 may be hubs 7001 configured to connect to hub adapter 7005 to allow magnetic torque transmission.

[0450] Hub 7001 can be configured to be located on the sterile side of a sterile barrier and is configured to adjust the axial position of the interventional device. Hub adapter 7005 can be configured to be located on the non-sterile side of a sterile barrier and is configured to move in at least one direction based on user-provided input from a robot drive system.

[0451] Any embodiment of the drive system disclosed herein may have multiple torque transmission systems 7000 configured as in any of the embodiments disclosed herein. In some embodiments, the active torque element 7002 of each of the multiple torque transmission systems 7000 may be connected to a hub adapter, and the passive torque element 7004 of each of the multiple torque transmission systems 7000 may be connected to one or more hubs of the robot drive system embodiment disclosed herein.

[0452] As described in this article, for example, refer to Figure 4 The hub adapter 7005 may further include a drive magnet configured to connect with a driven magnet of the hub 7001 such that when the driven magnet is magnetically connected to the drive magnet, the driven magnet and the hub 7001 move axially in response to movement of the drive magnet.

[0453] In any of the embodiments disclosed herein, the robot drive system may include at least three or at least four hub adapters (e.g., hub adapter 7005) and at least four hubs (e.g., hub 7001) and a plurality of torque transmission systems 7000, each hub adapter configured to be located on the non-sterile side of a sterile barrier and configured to move in at least one direction based on user-provided input to the robot drive system, each hub configured to be located on the sterile side of a sterile barrier and configured to adjust the axial position of the interventional device, the plurality of torque transmission systems 7000 configured as in any of the embodiments disclosed herein. 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 the 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 the at least three or at least four hubs may have a plurality of passive torque elements 7004 connected to the hub.

[0454] In some embodiments, the first magnet 7014 of the active torque element 7002 and the first magnet 7024 of the passive torque element 7004 may each have a diameter of 0.25 inches or about 0.25 inches, or 0.375 inches or about 0.375 inches, or 0.5 inches or about 0.5 inches. In some embodiments, the first magnet 7014 of the active torque element 7002 may be spaced 0.4 inches or about 0.4 inches 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 some embodiments, the first magnet 7024 of the passive torque element 7004 may be spaced 0.4 inches or about 0.4 inches 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 some embodiments, the first magnet 7014 of the active torque element 7002 may be spaced apart 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 by 0.25 inches or about 0.25 inches to 1 inch or about 1 inch. In some embodiments, the first magnet 7024 of the passive torque element 7004 may be spaced apart 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 by 0.25 inches or about 0.25 inches to 1 inch or about 1 inch.

[0455] This document also discloses embodiments of a method for rotating a surgical device on the sterile side of a sterile barrier. Some embodiments of the method may include magnetically connecting an active torque element 7002 located on the non-sterile side of the sterile barrier to a passive torque element 7004 located on the sterile side of the sterile barrier; connecting an instrument (e.g., an interventional device) to the passive torque element 7004; and rotating the active torque element 7002, thereby causing the passive torque element 7004, which is magnetically connected to the active torque element 7002, to rotate, and causing the instrument connected to the passive torque element 7004 to rotate. In some embodiments, the interventional device may be a catheter or a guidewire.

[0456] Some implementations of the method may include rotating the passive torque element 7004 to move the seal between various states around the conduit as described herein.

[0457] This document also discloses embodiments of a method for performing neurovascular surgery. Some embodiments of the method may include providing an interventional device assembly, which may include a guidewire, an access catheter, a guiding catheter, and / or a surgical catheter. The method may include one or more of the following: connecting a guidewire to a first passive torque element 7004 located on the sterile side of a sterile barrier, connecting an access catheter to a second passive torque element 7004 located on the sterile side of a sterile barrier, connecting a surgical catheter to a third passive torque element 7004 located on the sterile side of a sterile barrier, and connecting a guiding catheter to a fourth passive torque element 7004. The method may include one or more of the following: 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. The method may include one or more of the following: rotating a guidewire by rotating a first active torque element 7002, rotating an insertion catheter by rotating a second active torque element 7002, rotating a surgical catheter by rotating a third active torque element 7002, and rotating a guiding catheter by rotating a fourth active torque element 7002. In some embodiments, the first, second, third, and fourth active torque elements 7002 are each independently and movably carried by a separate hub adapter. In some embodiments, the surgical catheter may be an aspiration catheter, an embolization deployment catheter, a stent deployment catheter, a flow shunt deployment catheter, a diagnostic angiography catheter, a stent retrieval catheter, a clot retrieval device, a balloon catheter, a catheter facilitating percutaneous flap repair or replacement, or an ablation catheter.

[0458] Figure 44AA portion of an embodiment of a torque transmission system 7100 is shown, which can be configured to transmit torque force through a sterile barrier. The torque transmission system 7100 may have any features and / or functions that are the same as or similar to any other torque transmission system described herein, and vice versa. In some embodiments, the torque transmission system 7100 may include an active torque element (e.g., a first active torque element 7102A) and a passive torque element (e.g., a first passive torque element 7104A), the active torque element being configured to be located on the non-sterile side of the sterile barrier (e.g., the asset / equipment side), and the passive torque element being configured to be located on the sterile side of the sterile barrier (e.g., the disposable equipment side). The active torque element may have any features and / or functions that are the same as or similar to any other active torque element described herein, and vice versa. The passive torque element may have any features and / or functions that are the same as or similar to any other passive torque element described herein, and vice versa. Figures 44A to 44B A representative magnetic connection between the first active torque element 7102A and the first passive torque element 7104A is depicted. The magnetic connection can represent any magnetic connection between the active torque element and the passive torque element.

[0459] In some implementations, the active torque element 7102A may include a plurality of elements surrounding a central axis (in Figure 44A The magnets are arranged along axis A13. Multiple magnets may include one or more first magnets 7114 and one or more second magnets 7116. One or more first magnets 7114 may have an axial orientation towards the north pole or positive pole of the passive torque element. One or more second magnets 7116 may have an axial orientation towards the south pole or negative pole of the passive torque element. Magnets 7114 and 7116 may be wedge-shaped magnets. In some embodiments, wedge-shaped magnets can provide a larger magnetic surface area on the magnet support element compared to disk-shaped magnets located on the same magnet support element.

[0460] In some implementations, the multiple magnets of the active torque element 7102A may be arranged in a planar configuration on a plane parallel or substantially parallel to the sterile barrier.

[0461] 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 an axially facing south or negative pole of the active torque element. The one or more second magnets 7156 may include an axially facing north or positive pole of the active torque element. 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 arrangement on a plane parallel or substantially parallel to a sterile barrier.

[0462] 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. Rotation of the plurality of magnets of the active torque element 7102A around the central axis of the plurality of magnets of the active torque element 7102A can cause corresponding rotation of the plurality of magnets of the passive torque element 7104A around the central axis of the plurality of magnets of the passive torque element.

[0463] In some embodiments, the central axes of the plurality of magnets of the active torque element 7102A may be coaxial or parallel to the central axes of the plurality of magnets of the passive torque element 7104. In some embodiments, the central axes of the plurality of magnets of the active torque element 7102A and / or the central axes of the plurality of magnets of the passive torque element 7104A may 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 transmission system 7100 are connected.

[0464] like Figure 44A As shown, 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 a plurality of magnets of the active torque element. For example, the magnet support element 7140 may be configured to support a plurality of magnets of the active torque element in a radially planar arrangement around a central axis of a plurality of magnets (e.g., shaft A13). In some embodiments, the magnet support element 7140 may be formed of a ferrous material (e.g., steel), which may guide magnetic field lines away from the magnet support element 7140 (e.g., toward the passive torque element).

[0465] 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 a plurality of magnets of the passive torque element 7104A. For example, the magnet support element 7150 may be configured to support a plurality of magnets of the passive torque element 7104A in a radially planar arrangement around a central axis of a plurality of magnets (e.g., shaft A13). In some embodiments, the magnet support element 7150 may be formed of a ferrous material (e.g., steel), which may guide magnetic field lines away from the magnet support element 7150 (e.g., toward the active torque element 7102A).

[0466] In some embodiments, the plurality of magnets of the magnet support element 7140 and / or the active torque element 7102A can be rotated (e.g., by a motor) to cause rotation of the plurality of magnets of the passive torque element 7104A and / or the magnet support element 7150. As described herein, the plurality of magnets of the passive torque element 7104A and / or the magnet support element 7150 can be connected to a surgical instrument (e.g., an interventional device, a valve, etc.) such that rotation of the plurality of magnets of the passive torque element 7104A causes a corresponding movement of the surgical instrument (e.g., rotation of the interventional device, opening and / or closing of a valve (e.g., a stopcock or a hemostatic valve), etc.).

[0467] As described herein, the plurality of magnets of the active torque element 7102A can be configured to cause the plurality of magnets of the passive torque element 7104A to rotate across a sterile barrier.

[0468] Figure 44B Multiple magnets and magnet support elements 7140 of the active torque element 7102A are depicted. Figures 44C to 44D An example of magnet 7114 is depicted.

[0469] Figures 45A to 45B An implementation scheme of an active torque subsystem 7103 of a torque transmission system 7100 is described, which can be used to transmit torque force through a sterile barrier. Figures 45C to 45G An embodiment of the passive torque subsystem 7106 of the torque transmission system 7100 is described. The active torque subsystem 7103 can be configured to be located on the non-sterile side of a sterile barrier (e.g., the asset / equipment side). The passive torque subsystem 7106 can be configured to be located on the sterile side of a sterile barrier (e.g., the disposable equipment side).

[0470] The active torque subsystem 7103 may include one or more active torque elements. For example, the active torque subsystem 7103 may include a first active torque element 7102A, a second active torque element 7102B, and a third active torque element 7102C. Each active torque element may include, for example, […]. Figures 44A to 44DThe magnetic support element 7140 and the plurality of magnets 7114 and 7116 are described.

[0471] In some embodiments, each of one or more active torque elements may include a first gear 7186 connected to a second gear 7188. In some embodiments, the first gear 7186 and the second gear 7188 may be equal-diameter bevel gears (also referred to as conical gears). The first gear 7186 may be connected to a motor 7170. The motor 7170 may be configured to selectively apply torque to the first gear 7186 to cause the first gear 7186 to rotate. The first gear 7186 may be configured to rotate the second gear 7188. The second gear 7188 may be connected to a plurality of magnets 7114 and 7116 of the active torque elements. The plurality of magnets of the active torque elements may be configured to rotate when the second gear 7188 rotates. In some embodiments, the second gear 7188 may be connected to a magnet support element 7140 and configured to rotate the magnet support element 7140.

[0472] In some embodiments, the motor 7170 may be a servo motor. In some embodiments, as described herein, the torque transmission system 7100 may include a controller that is electrically in communication with the motor 7170, the active torque element, and the controller is configured to control the operation of the motor 7170 in response to inputs to the controller. The controller may be a microcontroller.

[0473] As described herein, in some embodiments, the active torque subsystem 7103 may be configured to be located on the non-sterile side of a sterile barrier (e.g., the asset / equipment side), and the passive torque subsystem 7106 may be configured to be located on the sterile side of a sterile barrier (e.g., the disposable equipment side). Furthermore, in any of the embodiments disclosed herein, the torque transmission system 7100 may be configured for use in a surgical robot drive system as described herein. For example, the active torque subsystem 7103 may be connected to a hub adapter, and the passive torque subsystem 7106 may be connected to the hub of the robot drive system.

[0474] In some embodiments, the active torque subsystem 7103 may include a support plate or a housing 7182. The housing 7182 may include a plurality of recesses 7178, each recess 7178 configured to receive a magnet support element 7140 of the active torque element therein. The respective dimensions of the plurality of recesses 7178 may be slightly larger than the magnet support element 7140, such that the magnet support element 7140 can rotate freely within the plurality of recesses 7178.

[0475] In some implementations, the passive torque subsystem 7106 may include one or more passive torque elements. For example... Figures 45C to 45GAs shown, the passive torque subsystem may include one or more passive torque elements. For example, the passive torque subsystem may include a first passive torque element 7104A, a second passive torque element 7104B, and a third passive torque element 7104C. Each of the one or more passive torque elements may be configured to cause responsive movement of other features of the surgical instrument or robotic surgical system in response to the transmission of magnetic force (e.g., torque force) from the active torque element to the passive torque element. For example, the first passive torque element 7104A may be configured to cause responsive movement of other features of the surgical instrument or robotic surgical system in response to the transmission of magnetic force from the first active torque element 7102A, the second passive torque element 7104B may be configured to cause responsive movement of other features of the surgical instrument or robotic surgical system in response to the transmission of magnetic force from the second active torque element 7102B, and the third passive torque element 7104C may be configured to cause responsive movement of other features of the surgical instrument or robotic surgical system in response to the transmission of magnetic force from the third active torque element 7102C.

[0476] In some embodiments, one or more passive torque elements may be configured to control the function of a hub or hub assembly (e.g., hub assembly 7200). In some embodiments, one or more passive torque elements may be configured to control medical devices or components of a robotic medical system. For example, in some embodiments, one or more passive torque elements may be configured to control the movement of an interventional device and / or control fluidic components connected to the interventional device (e.g., controllably select a fluidic configuration for a fluidic management system). For example, one or more passive torque elements may be configured to rotate an interventional device (e.g., a catheter or guidewire), translate an interventional device, manipulate an interventional device (in the case of a deflectable tip catheter), and / or rotate a valve to controllably select an active fluidic configuration. In some embodiments, one or more passive torque elements may be configured to manipulate sensors, e.g., to position a sensor (e.g., a bubble sensor) at a desired location for operation. In some embodiments, one or more passive torque elements may be configured to increase tension in the system. For example, one or more passive torque elements may cause tension to be applied to a stent retrieval device to allow the stent retrieval device to pull other interventional devices.

[0477] In some implementations, the first passive torque element 7104A can be configured as a rotary interventional device (e.g., a catheter or guidewire). ...

Claims

1. A hub assembly for an intervention device for robot operation driving, the hub assembly comprising: An interventional device hub, which has an interventional device; and At least one magnet, The hub assembly is configured to be located on the sterile side of a sterile area barrier and magnetically connected to a hub adapter on the non-sterile side of the sterile area barrier, such that the hub assembly moves axially in response to axial movement of the hub adapter, and at least one magnet of the hub assembly rotates in response to rotation of at least one magnet of the hub adapter.

2. The hub assembly of claim 1, wherein at least one magnet of the hub assembly is configured to be operatively connected to the interventional device such that rotation of at least one magnet of the hub assembly causes rotation of the interventional device.

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

4. The hub assembly of claim 1, wherein at least one magnet of the hub assembly is configured to be connected to a valve of the fluidic subsystem of the hub assembly.

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

6. The hub assembly of claim 4, wherein the valve is configured to selectively actuate fluid into or out of the intervention device.

7. The hub assembly of 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 and contrast agent.

8. The hub assembly of claim 1, wherein the at least one magnet comprises a magnet having a plurality of magnetic regions.

9. The hub assembly of claim 1, wherein 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.

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

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

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

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

14. The hub assembly of claim 13, wherein the magnet support is formed of ferrous material.

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

16. The hub assembly of claim 1, wherein the hub assembly includes a mounting member and an intervention device hub detachably connected to the mounting member.

17. The hub assembly of claim 16, wherein at least one magnet of the hub assembly is attached to the mounting member.

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

19. The hub assembly of claim 1, wherein the hub assembly includes a plurality of rollers configured to contact a drive surface.

20. The hub assembly of claim 19, wherein the plurality of rollers are configured to space at least one magnet of the hub assembly from the drive surface.

21. A robot drive system, comprising: A hub adapter, located on the non-sterile side of a sterile area barrier and configured for axial movement, includes at least one magnet. The hub adapter is configured to connect to a hub assembly on the sterile side of the sterile area 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.

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

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

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

25. The robot drive system of claim 21, wherein at least one magnet of the hub adapter comprises a cohesive magnet having a plurality of magnetic regions.

26. The robot drive system of claim 21, wherein at least one magnet of the hub adapter comprises a plurality of magnets, wherein at least one magnet of the hub assembly comprises a plurality of magnets, wherein each of the plurality of magnets of the hub adapter is configured to rotate to cause rotation of one of the plurality of magnets of the hub assembly.

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

28. The robot drive system of claim 27, wherein the magnet support is formed of an ferrous material.

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

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

31. The robot drive system of claim 30, wherein the plurality of rollers are configured to space at least one magnet of the hub adapter from the drive surface.

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

33. The robot drive system of claim 21, further comprising a hub assembly.

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

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

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

37. The robot drive system of claim 35, wherein the valve is configured to selectively actuate fluid into or out of the intervention device.

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

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

40. The robot drive system of claim 33, wherein the hub assembly includes a mounting member and an intervention device hub detachably connected to the mounting member.

41. A robot drive system, comprising: At least one magnet is located on the non-sterile side of a sterile area barrier; and A frame, with at least one magnet connected to the frame; The frame is configured to move from a retracted position to an extended position, wherein at least one magnet is closer to the sterile area barrier in the extended position than in the retracted position.

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

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

44. The robot drive system of claim 42, wherein the hub adapter is configured to translate axially along a first axis, and 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. The robot drive system of claim 44, wherein at least one magnet of the hub adapter is configured to rotate about a third axis, wherein the third axis is parallel to the second axis.

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

47. The robot drive system of claim 46, wherein the support component comprises a plurality of rollers.

48. A robot drive system, comprising: A torque transmission system, comprising: An active torque element located on the non-sterile side of a sterile area barrier, the active torque element comprising at least one magnet; A passive torque element located on the sterile side of the sterile area barrier, the passive torque element comprising at least one magnet and configured to be connected to an interventional device; The active torque element is configured to rotate to apply torque to the passive torque element, thereby causing the passive torque element and the intervention device to rotate.

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

50. The robot drive system of 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 of rotating a surgical device on the sterile side of a sterile area barrier, the method comprising: An active torque element located on the non-sterile side of a sterile area barrier is magnetically connected to a passive torque element located on the sterile side of a sterile area barrier, wherein the passive torque element is connected to the surgical device. and Rotating the active torque element causes the passive torque element, which is magnetically connected to the active torque element, and the surgical device connected to the passive torque element to rotate.

52. Methods of performing vascular surgery include: A multi-catheter assembly including an access catheter is provided, wherein the access catheter is connected to a first passive torque element located on the sterile side of a sterile area barrier; The first active torque element is magnetically connected to the first passive torque element; and The inlet conduit is rotated by rotating the first active torque element.

53. Methods of performing vascular surgery include: A hub assembly with an intervention device on the sterile side of a sterile area barrier is magnetically connected to a hub adapter on the non-sterile side of the sterile area barrier. Rotate at least one magnet of the hub adapter to cause rotation of at least one magnet of the hub assembly.

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