Robotic drive system for achieving supra-aortic access

Abstract

A drive system for achieving supra-aortic access and neurovascular treatment site access includes a guidewire hub configured to adjust the axial and rotational position of a guidewire, a treatment catheter hub configured to adjust the axial and rotational position of a treatment catheter, a guide catheter hub configured to adjust the axial position of a guide catheter, and an access catheter hub configured to adjust the axial and rotational position of an access catheter, the access catheter further configured to laterally deflect a distal deflection zone of the access catheter.

Description

[Technical Field]

[0001] Incorporation by reference to priority applications Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet filed with this application are hereby incorporated by reference under 37 CFR 1.57. This application is related to U.S. application Ser. No. 18 / 060,935, filed December 1, 2022, entitled "METHOD OF PRIMING AN INTERVENTIONAL DEVICE ASSEMBLY," U.S. application Ser. No. 18 / 073,291, filed December 1, 2022, entitled "METHOD OF PRIMING CONCENTRICALLY STACKED INTERVENTIONAL DEVICES," U.S. application Ser. No. 17 / 959,924, filed October 4, 2022, entitled "METHOD OF ROBOTICALLY DRIVING A MULTI-CATHETER ASSEMBLY ABOVE THE AORTIC ARCH," and U.S. application Ser. No. 17 / 959,924, filed October 4, 2022, entitled "ROBOTIC DRIVE SYSTEM FOR ACHIEVING SUPRA-AORTIC ARCH," and U.S. application Ser. This application claims the benefit of priority to U.S. application Ser. No. 17 / 959,894, entitled "METHOD OF PERFORMING A MULTI-CATHETER ROBOTIC NEUROVASCULAR PROCEDURE," filed October 4, 2022; U.S. application Ser. No. 17 / 960,014, entitled "METHOD OF PERFORMING A MULTI-CATHETER ROBOTIC NEUROVASCULAR PROCEDURE," filed August 1, 2022; and U.S. application Ser. No. 17 / 816,669, entitled "METHOD OF SUPRA-AORTIC ACCESS FOR A NEUROVASCULAR PROCEDURE," filed August 1, 2022.U.S. Application No. 18 / 060,935, filed December 1, 2022, entitled "METHOD OF PRIMING AN INTERVENTIONAL DEVICE ASSEMBLY," is a subsidiary of U.S. Application No. 17 / 959,924, filed October 4, 2022, entitled "METHOD OF ROBOTICALLY DRIVING A MULTI-CATHETER ASSEMBLY ABOVE THE AORTIC ARCH," U.S. Application No. 17 / 959,894, filed October 4, 2022, entitled "ROBOTIC DRIVE SYSTEM FOR ACHIEVING SUPRA-AORTIC ACCESS," and U.S. Application No. 17 / 959,894, filed October 4, 2022, entitled "METHOD OF PERFORMING A MULTI-CATHETER ROBOTIC NEUROVASCULAR ARCH," both of which are incorporated herein by reference. U.S. Application No. 18 / 073,291 is a continuation-in-part of U.S. Application No. 17 / 960,014, entitled "METHOD OF ROBOTICALLY DRIVING A MULTI-CATHETER ASSEMBLY ABOVE THE AORTIC ARCH PROCEDURE," filed October 4, 2022; U.S. Application No. 17 / 959,924, entitled "ROBOTIC DRIVE SYSTEM FOR ACHIEVING SUPRA-AORTIC ACCESS," filed October 4, 2022; and U.S. Application No. 17 / 960,014, entitled "METHOD OF PERFORMING A MULTI-CATHETER ROBOTIC NEUROVASCULAR PROCEDURE," filed October 4, 2022. U.S. Application No. 17 / 959,924 is a continuation-in-part of U.S. Application No. 17 / 816,669, entitled "METHOD OF SUPRA-AORTIC ACCESS FOR A NEUROVASCULAR PROCEDURE," filed August 1, 2022.U.S. Application No. 17 / 959,894 is a continuation-in-part of U.S. Application No. 17 / 816,669, entitled "METHOD OF SUPRA-AORTIC ACCESS FOR A NEUROVASCULAR PROCEDURE," filed August 1, 2022. U.S. Application No. 17 / 960,014 is a continuation-in-part of U.S. Application No. 17 / 816,669, entitled "METHOD OF SUPRA-AORTIC ACCESS FOR A NEUROVASCULAR PROCEDURE," filed August 1, 2022. The entire contents of each of the foregoing applications are incorporated by reference herein for all purposes and form a part of this specification.

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

[0003] Various neurovascular procedures, including thrombectomy, diagnostic angiography, embolization coil deployment, and stent placement, can be accomplished via transvascular access. However, the delivery of neurovascular care is limited or delayed by a variety of challenges. For example, there are insufficient trained interventionalists and centers to meet the current demand for neurointerventions. Neurointerventions are challenging, with complex setup requirements and demands on the surgeon's dexterity. Using both hands, the surgeon must exercise precise control over three to four coaxial catheters while managing the fluoroscopy system and patient positioning. Long, tortuous anatomies require delicate and precise manipulation. Inadvertent catheter movement can occur due to the storage and release of energy caused by frictional interactions between the coaxial shaft and the patient's vasculature. The supra-aortic access required to reach the neurovasculature is difficult to achieve, especially in type III arches. Once supra-aortic access is achieved, adapting the system for neurovascular treatment is time-consuming, requiring removal of the guidewire and access catheter and addition of the treatment catheter (and possibly one or more additional catheters) to the stack.

[0004] Thus, a need remains for a supra-aortic access and neurovascular site access system that addresses some or all of these challenges and improves the availability of neurovascular procedures. Preferably, the system would additionally be capable of driving devices further distally through the supra-aortic access to achieve procedures in intracranial vessels. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent No. 11,259,821 [Patent Document 2] U.S. Patent Application No. 63 / 256,743 [Patent Document 3] U.S. Patent Application Serial No. 17 / 527,393 [Patent Document 4] U.S. Patent Application Serial No. 17 / 879,614 Summary of the Invention [Means for solving the problem]

[0006] According to one aspect of the present disclosure, a supra-aortic access robotic control system is provided. The system includes a guidewire hub configured to adjust the axial and rotational positions of a guidewire; a guide catheter hub configured to adjust the axial position of a guide catheter; and an access catheter hub configured to adjust the axial and rotational positions of an access catheter. The access catheter hub is also capable of laterally deflecting a distal deflection zone of the access catheter. The guidewire hub can additionally be configured to laterally deflect a distal portion of the guidewire.

[0007] A treatment catheter hub configured to manipulate the treatment catheter can also be provided. Following robotic placement of the guidewire, access catheter, and guide catheter so that the guide catheter achieves supra-aortic access, the guidewire and access catheter can be withdrawn proximally, and the treatment catheter can be advanced through and over the guide catheter, with or without the support of the guidewire (which can be smaller in diameter and / or more flexible than the guidewire used to gain supra-aortic access), to reach a more distal neurovascular treatment site. The treatment catheter can be an aspiration catheter; an embolism deployment catheter; a stent deployment catheter; a flow diverter deployment catheter; an access catheter; a diagnostic angiography catheter; a guiding catheter, an imaging catheter, a physiological sensing / measuring catheter, an infusion or injection catheter, an ablation catheter, an RF ablation catheter or guidewire, a balloon catheter, or a microcatheter used to deliver a stent retriever, a balloon catheter, or a stent retriever.

[0008] The control system may further include a driven magnet on each of the guidewire hub, the access catheter hub, and the guide catheter hub, the driven magnet configured to cooperate with a corresponding drive magnet such that the driven magnet moves in response to movement of the corresponding drive magnet. The drive magnets may each be carried by the support table for independent axial movement. The drive magnet may be positioned outside the sterile field separated from the driven magnet by a barrier, and the driven magnet may be within the sterile field. The barrier may include a tray made of a thin polymer film or any film of a non-ferromagnetic material.

[0009] The control system can further include a control console, which can be connected to the support table or can be located remotely from the support table, and the position of each driven magnet and corresponding hub is movable in response to manual manipulation of a guidewire drive control, an access catheter drive control, or a treatment catheter drive control on the console or on a specific controller not associated with the console.

[0010] The control system can further include a processor for controlling the position of the drive magnet. The processor can be in wired or wireless communication with the control console. The driven magnet can be configured to remain engaged with the corresponding drive magnet until an axial breaking force of at least about 300 grams is applied.

[0011] Also provided is a robotically driven interventional device. The device includes an elongated flexible body having a proximal end and a distal end. A hub is provided at the proximal end. At least one rotatable roller is provided on a first surface of the hub; and at least one magnet is provided on the first surface of the hub. The roller can extend farther away from the first surface than the magnet. The hub can further be provided with at least a second roller.

[0012] Any of the guidewire hub, access catheter hub, and treatment catheter hub can be further provided with a rotational drive to rotate the corresponding interventional device relative to the hub. The hub can further be provided with an axial drive mechanism to distally advance or proximally retract a control element extending axially through the interventional device to adjust attributes such as the shape or flexibility of the interventional device. In some embodiments, at least one control element can be an axially movable tubular body or fiber, ribbon, or wire, such as a pull wire, that extends through the interventional device to, for example, the distal deflection zone. In some embodiments, any number of control elements can be similarly advanced, retracted, or otherwise moved.

[0013] Also provided is a control system for controlling movement of an interventional device. In one configuration, the control system includes a guidewire control configured to control the axial travel and rotation of the guidewire; an access catheter control configured to control the axial and rotational movement of the access catheter; and a guide catheter control configured to control the axial movement and / or rotation of the guide catheter.

[0014] The control system may further include a deflection control configured to control deflection of the access catheter or treatment catheter, and may be configured for wired or wireless communication with the robotic catheter drive system.

[0015] The control system can be configured to independently control three or more hubs in various modes. For example, two or more hubs can be selectively grouped together so that they drive each device simultaneously with the same motion. Alternatively, the control system can be configured to drive each device simultaneously but with different motions.

[0016] The control system may further include a physician interface for operating the control system. The physician interface may be carried by a support table having a robotic interventional device drive system. Alternatively, the physician interface for operating the control system may be carried on a portable handheld device or desktop computer and may be located in the same room as the patient, in the same facility as the patient, or in a remote facility.

[0017] The control system may further include a graphical user interface with at least one display for indicating the status of at least one device parameter and / or for indicating the status of at least one patient parameter.

[0018] Also provided is a sterile packaging assembly for transporting interventional devices to a robotic surgical site. The packaging assembly can include a base and a sterile barrier configured to enclose a sterile volume. At least one interventional device can be provided within the sterile volume, the device including a hub and an elongated, flexible body. The hub can include at least one magnet and at least one roller configured to roll on the base.

[0019] In one implementation, the sterile barrier is removably attached to the base and defines an enclosed volume between the sterile barrier and the base. In another implementation, the sterile barrier is in the form of a tubular enclosure for enclosing the sterile volume. The tubular enclosure can surround the base and at least one interventional device, which are within the sterile volume.

[0020] The hubs can be oriented in the packaging with the rollers and magnets facing the base. Alternatively, the base can be in the form of a tray having an elongated central axis. The upper sterile field side of the tray can have an elongated support surface for supporting and allowing sliding movement of the one or more hubs. At least one, and optionally two, elongated trays can be provided extending parallel to the central axis. At least one hub and interventional device can be provided in the tray, and the sterile tray with the sterile hub and interventional device can be positioned in the sterile volume defined by the sterile barrier.

[0021] The base can be configured to reside on a support table adjacent to the patient, with an upper surface of the base within the sterile field and a lower surface of the base outside the sterile field.

[0022] Any of the hubs disclosed herein can further include a fluid injection port and / or a wireless RF transceiver for communication and / or power transfer. The hub can include a visual indicator to indicate the presence of a clot. In some embodiments, the hub can also include wired electrical communication and power ports. The visual indicator can include a clot chamber with a transparent window. A filter can be provided in the clot chamber.

[0023] Any of the hubs disclosed herein can further include a sensor for detecting a parameter of interest, such as the presence of a blood clot. In some cases, the sensor can be positioned on the flexible body. The sensor can include a pressure sensor or an optical sensor. In some embodiments, the sensor can include one or more of a force sensor, a positioning sensor, a temperature sensor, and / or an oxygen sensor. In some embodiments, the sensor can include a fiber Bragg grating sensor. For example, a fiber Bragg grating sensor (e.g., an optical fiber) can locally detect strain, which can facilitate detection and / or determination of an applied force. The device can further include multiple sensors. The multiple sensors can each include one or more of any type of sensor disclosed herein. In some embodiments, multiple (e.g., three or more) sensors (e.g., fiber Bragg grating sensors) can be distributed around the perimeter to facilitate detection and / or determination of shape. The position of the device can, in some cases, be determined through the use of one or more sensors to detect and / or determine position. For example, one or more optical encoders can be positioned in or adjacent to one or more motors that drive linear motion, such that the optical encoders can determine position.

[0024] Also provided is a method for performing a neurovascular procedure, wherein a first aspect includes robotically achieving supra-aortic access and a second aspect includes manually or robotically performing a neurovascular procedure via supra-aortic access. The method includes the steps of providing an access catheter having an access catheter hub; coupling the access catheter hub to a hub adapter movably carried by a support table; and actuating the access catheter in response to movement of the hub adapter along the table until the access catheter is positioned to achieve supra-aortic access. The access catheter and access catheter hub can then be released from the hub adapter; and a treatment catheter hub with the treatment catheter can then be coupled to the hub adapter.

[0025] The method can additionally include advancing the treatment catheter hub to position a distal end of the treatment catheter at the neurovascular treatment site. Driving the access catheter can include driving the access catheter distally through the guide catheter. Driving the access catheter can include laterally deflecting a distal region of the access catheter to achieve supra-aortic access. In some embodiments, driving the access catheter can also include rotating the access catheter.

[0026] Also provided is a method for performing a neurovascular procedure, which includes providing an access assembly including a guidewire, an access catheter, and a guide catheter. The access assembly can be releasably coupled to a robotic drive system. The access assembly can be driven by the robotic drive system to achieve access to a desired point, such as to achieve supra-aortic access. The guidewire and access catheter can then be released from the access assembly, leaving the guide catheter in place. A treatment assembly can be provided including at least the guidewire and a first treatment catheter. The treatment assembly can be releasably coupled to the robotic drive system; the neurovascular procedure can be accomplished using the treatment assembly. Also provided is a second treatment catheter for extending through the first treatment catheter to a treatment site.

[0027] The step of coupling the access assembly can include magnetically coupling a hub on each of the guidewire, the access catheter, and the guide catheter to a separate corresponding coupler carrying a corresponding drive magnet independently movably carried by a drive table. The treatment assembly can include a guidewire, a first catheter, and a second catheter. The guidewire and the first catheter can be concentrically positioned within the second catheter. The treatment assembly can be advanced as a unit through at least a portion of the length of the guide catheter, and the treatment can include neurovascular thrombectomy.

[0028] Also provided is a method of performing a neurovascular procedure, comprising providing a multi-catheter assembly including an access catheter, a guide catheter, and a treatment catheter, coupling the assembly to a robotic drive system, driving the assembly to achieve supra-aortic access, driving a subset of the assembly to a neurovascular site, the subset including the guide catheter and the treatment catheter, proximally removing the access catheter, and performing the neurovascular procedure using the treatment catheter.

[0029] The neurovascular procedure can include neurovascular thrombectomy. The assembly can further include a guidewire, wherein the guidewire, access catheter, guide catheter, and treatment catheter are each configured to be adjusted by a respective hub. Coupling the assembly to the robotic drive system can include magnetically coupling a first hub of the guidewire to a first drive magnet, a second hub of the access catheter to a second drive magnet, a third hub of the guide catheter to a third drive magnet, and a fourth hub of the treatment catheter to a fourth drive magnet. The first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet can each be independently movably carried by a drive table. The treatment catheter can be an aspiration catheter. The treatment catheter can be an embolism deployment catheter. The treatment catheter can be a stent deployment catheter. The treatment catheter can be a flow diverter deployment catheter. The treatment catheter can be a diagnostic angiography catheter. The treatment catheter can be a stent retriever catheter. The treatment catheter can be a clot retriever. The treatment catheter can be a balloon catheter. The treatment catheter can be a catheter for facilitating percutaneous valve repair or replacement. The treatment catheter can be an ablation catheter.

[0030] Also provided is a method of performing a neurovascular procedure, the method comprising providing an assembly including a guidewire, an access catheter, a guide catheter, and a treatment catheter coaxially and movably assembled into a single multi-catheter assembly, coupling the assembly to a drive system, driving the assembly to achieve supra-aortic access, driving a subset of the assemblies to an intracranial site, the subset including the guidewire, the guide catheter, and the treatment catheter, and performing the neurovascular procedure using the subset of the assemblies.

[0031] Each of the guidewire, access catheter, guide catheter, and treatment catheter can be configured to be adjusted by a respective hub. Coupling the assembly to the drive system can include magnetically coupling a first hub of the guidewire to a first drive magnet, a second hub of the access catheter to a second drive magnet, a third hub of the guide catheter to a third drive magnet, and a fourth hub of the treatment catheter to a fourth drive magnet. The drive system can be a robotic drive system, and the first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet can each be independently movably carried by a drive table associated with the robotic drive system. The first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet can each be independently movably carried by the drive table.

[0032] Also provided is a method of performing a neurovascular procedure. The method includes providing an assembly including a guidewire having a guidewire hub, an access catheter having an access catheter hub, and a guide catheter having a guide catheter hub. The method also includes coupling the guidewire hub to a first hub adapter, coupling the access catheter hub to a second hub adapter, and coupling the guide catheter hub to a third hub adapter, each of the first hub adapter, the second hub adapter, and the third hub adapter being movably carried by a support table. The method also includes actuating the assembly in response to movement of each of the first hub adapter, the second hub adapter, and the third hub adapter along the support table until the assembly is positioned to provide supra-aortic vascular access.

[0033] The method may include driving a subset of assemblies along a support table until the subset of assemblies is positioned to perform a neurovascular procedure at a neurovascular treatment site, the subset of assemblies including a guidewire, a guide catheter, and a treatment catheter. The neurovascular procedure may include a thrombectomy. Coupling the guidewire hub to the first hub adapter may include magnetically coupling the guidewire hub to a first drive magnet. Coupling the access catheter hub to the second hub adapter may include magnetically coupling the access catheter hub to a second drive magnet. Coupling the guide catheter hub to the third hub adapter may include magnetically coupling the guide catheter hub to a third drive magnet. The first drive magnet, the second drive magnet, and the third drive magnet may be independently movably carried by the support table. The first drive magnet may be coupled to the first driven magnet across a sterile field barrier. The second drive magnet can be coupled to the second driven magnet across the sterile field barrier. The third drive magnet can be coupled to the third driven magnet across the sterile field barrier. Coupling the guidewire hub to the first hub adapter can include mechanically coupling the guidewire hub to a first drive unit. Coupling the access catheter hub to the second hub adapter can include mechanically coupling the access catheter hub to a second drive unit. Coupling the guide catheter hub to the third hub adapter can include mechanically coupling the guide catheter hub to a third drive unit. The guidewire and guide catheter can be advanced as a unit along at least a portion of the length of the access catheter after supra-aortic access is achieved. The guidewire hub can be configured to adjust the axial and rotational position of the guidewire. The assembly can further include a treatment catheter having a treatment catheter hub.The treatment catheter hub can be configured to adjust the axial and rotational position of the treatment catheter. The treatment catheter hub can be further configured to laterally deflect a distal deflection zone of the treatment catheter. The guidewire hub can be configured to adjust the axial and rotational position of the guidewire. The treatment catheter hub can be configured to adjust the axial and rotational position of the treatment catheter. The guide catheter hub can be configured to adjust the axial position of the guide catheter. The access catheter hub can be configured to adjust the axial and rotational position of the access catheter. The treatment catheter hub can be further configured to laterally deflect a distal deflection zone of the treatment catheter. The access catheter hub can be further configured to laterally deflect a distal deflection zone of the access catheter. The guide catheter hub can be configured to adjust the axial position of the guide catheter. The access catheter hub can be configured to adjust the axial and rotational position of the access catheter. The access catheter hub can be further configured to laterally deflect a distal deflection zone of the access catheter.

[0034] Also provided is a drive system for achieving supra-aortic access and neurovascular treatment site access, the system including a guidewire hub configured to adjust the axial and rotational position of a guidewire, a treatment catheter hub configured to adjust the axial position of a treatment catheter, a guide catheter hub configured to adjust the axial position of a guide catheter, and an access catheter hub configured to adjust the axial and rotational position of an access catheter.

[0035] The treatment catheter hub can be further configured to laterally deflect a distal deflection zone of the treatment catheter. The guidewire hub can be configured to couple to the guidewire hub adapter by magnetically coupling the guidewire hub to a first drive magnet. The access catheter hub can be configured to couple to the access catheter hub adapter by magnetically coupling the access catheter hub to a second drive magnet. The guide catheter hub can be configured to couple to the guide catheter hub adapter by magnetically coupling the guide catheter hub to a third drive magnet. The treatment catheter hub can be configured to couple to the treatment catheter hub adapter by magnetically coupling the treatment catheter hub to a fourth drive magnet. The first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet can be independently movably carried by a drive table. The system can further include a first driven magnet on the guidewire hub, the first driven magnet configured to cooperate with the first drive magnet such that the first driven magnet moves in response to movement of the first drive magnet. The first drive magnet can be configured to move outside the sterile field while separated from the first driven magnet by a sterile field barrier, while the first driven magnet is within the sterile field. The position of the first drive magnet can be movable in response to manipulation of a treatment drive control on a control console in electrical communication with the drive table. The system can further include a second driven magnet on the access catheter hub, the second driven magnet configured to cooperate with the second drive magnet such that the second driven magnet is configured to move in response to movement of the second drive magnet, the second drive magnet configured to move outside the sterile field while separated from the second driven magnet by a barrier, while the second driven magnet is within the sterile field.The system may further include a third driven magnet on the guide catheter hub, the third driven magnet configured to cooperate with the third drive magnet such that the third driven magnet is configured to move in response to movement of the third drive magnet, the third drive magnet configured to move outside the sterile field while separated from the third driven magnet by a barrier, while the third driven magnet is within the sterile field. The system may further include a fourth driven magnet on the treatment catheter hub, the fourth driven magnet configured to cooperate with the fourth drive magnet such that the fourth driven magnet is configured to move in response to movement of the fourth drive magnet, the fourth drive magnet configured to move outside the sterile field while separated from the fourth driven magnet by a barrier, while the fourth driven magnet is within the sterile field. The treatment catheter may be an aspiration catheter. The treatment catheter may be an embolism deployment catheter. The treatment catheter may be a stent deployment catheter. The treatment catheter can be a flow diverter deployment catheter. The treatment catheter can be a diagnostic angiography catheter. The treatment catheter can be a stent retriever catheter. The treatment catheter can be a balloon catheter. The treatment catheter can be a catheter for facilitating percutaneous valve repair or replacement. The treatment catheter can be an ablation catheter. The treatment catheter hub can be configured to adjust the rotational position of the treatment catheter. The access catheter hub can be configured to laterally deflect a distal deflection zone of the access catheter.

[0036] Also provided is a method for achieving supra-aortic access and neurovascular treatment site access. The method includes providing a drive system including a guidewire hub configured to adjust the axial and rotational position of a guidewire, a treatment catheter hub configured to adjust the axial and rotational position of a treatment catheter, a guide catheter hub configured to adjust the axial position of the guide catheter, and an access catheter hub configured to adjust the axial and rotational position of an access catheter, the access catheter further configured to laterally deflect a distal deflection zone of the access catheter, and the method includes moving at least one of the guidewire hub, treatment catheter hub, guide catheter hub, and access catheter hub to drive movement of at least one of the guidewire, treatment catheter, guide catheter, and access catheter. The method can further include controlling the treatment catheter hub to laterally deflect the distal deflection zone of the treatment catheter.

[0037] Also provided is a method of achieving supra-aortic access, the method comprising the steps of providing an assembly including a guidewire, an access catheter, and a guide catheter coaxially and movably assembled into a single multi-catheter assembly, coupling the assembly to a drive system, driving the assembly to the aortic arch, and advancing the access catheter to a branch vessel of the aortic arch to achieve supra-aortic access.

[0038] The method may further include driving a subset of the assemblies to an intracranial site and performing a neurovascular procedure using the subset of the assemblies. The subset may include a guidewire, a guide catheter, and a treatment catheter. The treatment catheter may be an aspiration catheter. The treatment catheter may be an embolism deployment catheter. The treatment catheter may be a stent deployment catheter. The treatment catheter may be a flow diverter deployment catheter. The treatment catheter may be a diagnostic angiography catheter. The treatment catheter may be a stent retriever catheter. The treatment catheter may be a clot retriever. The treatment catheter may be a balloon catheter. The treatment catheter may be a catheter for facilitating percutaneous valve repair or replacement. The treatment catheter may be an ablation catheter. The intracranial procedure may include an intracranial thrombectomy. The neurovascular procedure may include a neurovascular thrombectomy. At least one of the guidewire, access catheter, and guide catheter may include a hub configured to couple to a robotic drive system. Coupling the assembly to the drive system can include magnetically coupling the guide catheter hub to the drive system. Coupling the assembly to the drive system can include mechanically coupling the guide catheter hub to the drive system. The drive system can be a robotic drive system, wherein at least a first drive magnet, a second drive magnet, and a third drive magnet are each independently movably carried by a drive table associated with the robotic drive system.

[0039] Also provided is a method of priming an interventional device assembly, comprising: providing an interventional device assembly, the interventional device assembly including a first interventional device coupled to a first hub and a second interventional device coupled to a second hub arranged in a concentric stack, the second interventional device positioned within a lumen of the first interventional device; coupling the interventional device assemblies in the concentric stacked state to a drive system; axially advancing the first interventional device and the first hub relative to the second hub to reduce a depth of insertion of the second interventional device within the lumen of the first interventional device while maintaining a distal end of the second interventional device within the lumen of the first interventional device; and flushing the first interventional device with a fluid after reducing the depth of insertion of the second interventional device within the lumen of the first interventional device.

[0040] The drive system can be a robotic drive system. Axially advancing the first interventional device and the first hub relative to the second hub can include axially moving a first robotic drive coupled to the first hub relative to a second robotic drive coupled to the second hub. Axially advancing the first interventional device and the first hub relative to the second hub can include axially advancing the first interventional device and the first hub relative to the second hub in response to a control signal. The first interventional device can be a first catheter, and the second interventional device can be a second catheter. The first catheter can be a guide catheter, the first hub can be a guide catheter hub, the second catheter can be a treatment catheter, and the second hub can be a treatment catheter hub. The interventional device assembly can include an access catheter coupled to an access catheter hub arranged in a concentric stack, the access catheter positioned within a lumen of the treatment catheter. The method may include returning the guide catheter to an initial position relative to the treatment catheter after flushing the guide catheter with fluid, axially advancing the guide catheter, guide catheter hub, treatment catheter, and treatment catheter hub relative to the access catheter hub to reduce the depth of insertion of the access catheter within the lumen of the treatment catheter while maintaining the distal end of the access catheter within the lumen of the treatment catheter and substantially maintaining a relative position between the guide catheter and the treatment catheter, and flushing the treatment catheter with fluid after reducing the depth of insertion of the access catheter within the lumen of the treatment catheter. The interventional device assembly may include a guidewire coupled to a guidewire hub arranged in a concentric catheter stack, the guidewire being positioned within the lumen of the access catheter.The method may include returning the guide catheter and treatment catheter to their initial positions relative to the access catheter after flushing the treatment catheter with fluid; axially advancing the guide catheter, guide catheter hub, treatment catheter, treatment catheter hub, access catheter, and access catheter hub relative to the guidewire hub while maintaining the distal end of the guidewire within the lumen of the access catheter and substantially maintaining the relative positions among the guide catheter, treatment catheter, and access catheter, to reduce the insertion depth of the guidewire within the lumen of the access catheter; and flushing the access catheter with fluid after reducing the insertion depth of the guidewire within the lumen of the access catheter. The method may include flushing a second catheter with fluid, wherein the steps of flushing the first catheter and flushing the second catheter are performed simultaneously. The fluid may be saline, a contrast medium, or a combination of saline and a contrast medium. The first interventional device may be a catheter, and the second interventional device may be a guidewire. The method may include, after reducing the depth of insertion of the second interventional device within the lumen of the first interventional device, moving at least one of the first interventional device and the second interventional device back and forth relative to the other of the first interventional device and the second interventional device while flushing the first interventional device with a fluid.

[0041] Also provided is a method of priming a multi-catheter assembly, the method including providing a multi-catheter assembly including a guidewire, an access catheter, a treatment catheter, and a guide catheter in a concentric stacked configuration, coupling the multi-catheter assembly to a drive system, translating the guide catheter distally relative to the guidewire, the access catheter, and the treatment catheter, flushing the guide catheter with a fluid, and translating the guide catheter proximally toward the guidewire, the access catheter, and the treatment catheter.

[0042] The drive system can be a robotic drive system. The method can include translating the treatment catheter and the guide catheter distally relative to the guidewire and the access catheter, flushing the treatment catheter with a fluid, and translating the treatment catheter and the guide catheter proximally toward the guidewire and the access catheter. The method can include translating the access catheter, the treatment catheter, and the guide catheter distally relative to the guidewire, flushing the access catheter with a fluid, and translating the access catheter, the treatment catheter, and the guide catheter proximally toward the guidewire. The fluid can be saline, a contrast medium, or a combination of saline and a contrast medium. The guidewire can be coupled to a guidewire hub. The access catheter can be coupled to an access catheter hub. The treatment catheter can be coupled to a treatment catheter hub. The guide catheter can be coupled to a guide catheter hub. In the concentric stacked configuration, the treatment catheter is positioned within the lumen of the guide catheter, the access catheter is positioned within the lumen of the treatment catheter, and the guidewire is positioned within the lumen of the access catheter. The method can include reciprocating at least one of the guide catheter and the treatment catheter relative to the other of the guide catheter and the treatment catheter while flushing the guide catheter with a fluid.

[0043] Also provided is a method of priming an interventional device assembly, the method including providing an interventional device assembly including a first interventional device and a second interventional device positioned within the first interventional device, and reciprocating at least one of the first interventional device and the second interventional device relative to the other of the first interventional device and the second interventional device while flushing a lumen between the first interventional device and the second interventional device with a fluid to remove microbubbles from the lumen.

[0044] Reciprocating at least one of the first and second interventional devices relative to the other of the first and second interventional devices can include reciprocating at least one of the first and second interventional devices relative to the other of the first and second interventional devices in response to a control signal. Reciprocating at least one of the first and second interventional devices relative to the other of the first and second interventional devices can include reciprocating at least one of a first robotic drive coupled to the first interventional device and a second robotic drive coupled to the second interventional device relative to the other of the first robotic drive and the second robotic drive. Reciprocating at least one of the first and second interventional devices relative to the other of the first and second interventional devices can include reciprocating at least one of the first and second interventional devices axially relative to the other of the first and second interventional devices. Reciprocating at least one of the first and second interventional devices relative to the other of the first and second interventional devices can further include rotationally reciprocating at least one of the first and second interventional devices relative to the other of the first and second interventional devices. Reciprocating axially at least one of the first and second interventional devices relative to the other of the first and second interventional devices can include axially reciprocating at least one of the first and second interventional devices relative to the other of the first and second interventional devices over a stroke length of between about 10 mm and about 250 mm.Axially reciprocating at least one of the first and second interventional devices relative to the other of the first and second interventional devices can include axially reciprocating at least one of the first and second interventional devices relative to the other of the first and second interventional devices over a stroke length of between about 25 mm and about 125 mm. Axially reciprocating at least one of the first and second interventional devices relative to the other of the first and second interventional devices can include axially reciprocating at least one of the first and second interventional devices relative to the other of the first and second interventional devices over a stroke length greater than 20 mm. Axially reciprocating at least one of the first and second interventional devices relative to the other of the first and second interventional devices can include axially reciprocating at least one of the first and second interventional devices relative to the other of the first and second interventional devices at a reciprocating frequency of about 5 Hz or less. The reciprocating frequency can be about 1 Hz or less. Axially reciprocating at least one of the first and second interventional devices relative to the other of the first and second interventional devices can include rotationally reciprocating at least one of the first and second interventional devices relative to the other of the first and second interventional devices. Axially reciprocating at least one of the first and second interventional devices relative to the other of the first and second interventional devices can include reciprocating both the first and second interventional devices relative to each other.The reciprocating movement of at least one of the first and second interventional devices relative to the other of the first and second interventional devices can be performed by a robotic drive table. The first interventional device can be a first catheter, and the second interventional device can be a second catheter. The first interventional device can be a catheter, and the second interventional device can be a guidewire.

[0045] Also provided is a method of priming a multi-catheter assembly that includes providing a multi-catheter assembly including a guidewire, an access catheter, a treatment catheter, and a guide catheter arranged in a concentric catheter stack, the guidewire being positioned within a lumen of the access catheter, the access catheter being positioned within a lumen of the treatment catheter, and the treatment catheter being positioned within a lumen of the guide catheter, and flushing the guide catheter with saline while reciprocating at least one of the guide catheter and the treatment catheter relative to the other of the guide catheter and the treatment catheter.

[0046] Flushing the guide catheter with saline while reciprocating at least one of the guide catheter and the treatment catheter relative to the other of the guide catheter and the treatment catheter may include reciprocating at least one of the guide catheter and the treatment catheter relative to the other of the guide catheter and the treatment catheter in response to a control signal. Flushing the guide catheter with saline while reciprocating at least one of the guide catheter and the treatment catheter relative to the other of the guide catheter and the treatment catheter may include reciprocating at least one of a first robotic drive coupled to the guide catheter and a second robotic drive coupled to the treatment catheter relative to the other of the first robotic drive and the second robotic drive. Flushing the guide catheter with saline while reciprocating at least one of the guide catheter and the treatment catheter relative to the other of the guide catheter and the treatment catheter may include reciprocating at least one of the guide catheter and the treatment catheter axially, rotationally, or both axially and rotationally relative to the other of the guide catheter and the treatment catheter. The method can include flushing the treatment catheter with saline while reciprocating at least one of the treatment catheter and the access catheter relative to the other of the treatment catheter and the access catheter. Flushing the treatment catheter with saline while reciprocating at least one of the treatment catheter and the access catheter relative to the other of the treatment catheter and the access catheter can include reciprocating at least one of the treatment catheter and the access catheter axially, rotationally, or both axially and rotationally relative to the other of the treatment catheter and the access catheter.The method may include flushing the access catheter with saline while reciprocating at least one of the access catheter and the guidewire relative to the other of the access catheter and the guidewire. Flushing the access catheter with saline while reciprocating at least one of the access catheter and the guidewire may include reciprocating at least one of the access catheter and the guidewire axially, rotationally, or both axially and rotationally relative to the other of the access catheter and the guidewire. The steps of flushing the guide catheter with saline while reciprocating at least one of the guide catheter and the treatment catheter relative to the other of the guide catheter and the treatment catheter, flushing the treatment catheter with saline while reciprocating at least one of the treatment catheter and the access catheter relative to the other of the treatment catheter and the access catheter, and flushing the access catheter with saline while reciprocating at least one of the access catheter and the guidewire relative to the other of the access catheter and the guidewire may be performed simultaneously.

[0047] Also provided is a system for performing a neurovascular procedure, the system including an interventional device assembly including a guidewire having a guidewire hub, an access catheter having an access catheter hub, and a guide catheter having a guide catheter hub, a first hub adapter, where the guidewire hub is configured to couple to the first hub adapter, a second hub adapter, where the access catheter hub is configured to couple to the second hub adapter, a third hub adapter, where the guide catheter hub is configured to couple to the third hub adapter, and a support table on which each of the first hub adapter, the second hub adapter, and the third hub adapter are movably carried by the support table, the first hub adapter, the second hub adapter, and the third hub adapter configured to move along the support table to drive the interventional device assembly until the interventional device assembly is positioned to provide supra-aortic vascular access.

[0048] The interventional device assembly may include a treatment catheter having a treatment catheter hub. The system may include a fourth hub adapter, with the treatment catheter hub configured to couple to the fourth hub adapter. The first hub adapter, the third hub adapter, and the fourth hub adapter may be configured to move along the support table to drive the guidewire, the guide catheter, and the treatment catheter to a position for performing a neurovascular procedure at a neurovascular treatment site. The neurovascular procedure may be a thrombectomy. The guidewire hub may be configured to couple to the first hub adapter by magnetically coupling the guidewire hub to a first drive magnet. The access catheter hub may be configured to couple to the second hub adapter by magnetically coupling the access catheter hub to a second drive magnet. The guide catheter hub may be configured to couple to the third hub adapter by magnetically coupling the guide catheter hub to a third drive magnet. The first drive magnet, the second drive magnet, and the third drive magnet may be independently movably carried by the support table. The first drive magnet can be coupled to the first driven magnet across the sterile field barrier. The second drive magnet can be coupled to the second driven magnet across the sterile field barrier. The third drive magnet can be coupled to the third driven magnet across the sterile field barrier. The guidewire and guide catheter can be configured to advance as a unit along at least a portion of the length of the access catheter after supra-aortic access is achieved. The guidewire hub can be configured to adjust the axial and rotational position of the guidewire. The interventional device assembly can include a treatment catheter having a treatment catheter hub. The treatment catheter hub can be configured to adjust the axial position of the treatment catheter. The guide catheter hub can be configured to adjust the axial position of the guide catheter.The access catheter hub can be configured to adjust the axial and rotational position of the access catheter. The treatment catheter hub can be configured to adjust the rotational position of the treatment catheter. The treatment catheter hub can be configured to laterally deflect a distal deflection zone of the treatment catheter. The access catheter hub can be configured to laterally deflect a distal deflection zone of the access catheter. The first hub adapter, the second hub adapter, the third hub adapter, and / or the fourth hub adapter can be driven by a control system. The first hub adapter, the second hub adapter, the third hub adapter, and / or the fourth hub adapter can be driven in response to a user input using the control system. [Brief explanation of the drawings]

[0049] [Figure 1] FIG. 1 is a schematic perspective view of an interventional setup having an imaging system, a patient support table, and a robotic drive system according to the present disclosure. [Figure 2] FIG. 1 is a longitudinal cross-sectional view showing the concentric relationship between a guidewire with two degrees of freedom, an access catheter with three degrees of freedom, and a guide catheter with one degree of freedom. [Figure 3A] FIG. 1 is an exploded schematic view of an interventional device hub separated from a support table by a sterile barrier. [Figure 3B] FIG. 10 shows an alternative sterility barrier in the form of a shipping tray having one or more storage channels for carrying interventional devices. [Figure 3C] FIG. 10 shows an alternative sterility barrier in the form of a shipping tray having one or more storage channels for carrying interventional devices. [Figure 3D] FIG. 10 shows an alternative sterility barrier in the form of a shipping tray having one or more storage channels for carrying interventional devices. [Figure 3E]FIG. 10 shows an alternative sterility barrier in the form of a shipping tray having one or more storage channels for carrying interventional devices. [Figure 3F] FIG. 10 shows an alternative sterility barrier in the form of a shipping tray having one or more storage channels for carrying interventional devices. [Figure 3G] 10A-10C show alternative sterility barrier embodiments having convex drive surfaces. [Figure 3H] 10A-10C show alternative sterility barrier embodiments having convex drive surfaces. [Figure 3I] 10A-10C show alternative sterility barrier embodiments having convex drive surfaces. [Figure 3J] 10A-10C show alternative sterility barrier embodiments having convex drive surfaces. [Figure 3K] 10A-10C show alternative sterility barrier embodiments having convex drive surfaces. [Figure 3L] 3A-3K depict examples of hubs that may be used with the sterility barriers of FIGS. 3G-3K. [Figure 3M] 3A-3K depict examples of hubs that may be used with the sterility barriers of FIGS. 3G-3K. [Figure 4] FIG. 1 is a schematic elevational cross-section through a hub adapter having a drive magnet separated from an interventional device hub and driven magnet by a sterile barrier. [Figure 5A] FIG. 10 is a diagram illustrating a schematic of an interventional device assembly having three interventional devices. [Figure 5B] FIG. 10 is a diagram illustrating a schematic diagram of an interventional device assembly having four interventional devices. [Figure 6] FIG. [Figure 7] FIG. 10 is a close-up view of the motor-driven end of the support table. [Figure 8] 1 is an elevational section through the motor and belt drive assembly. [Figure 9] FIG. 10 is a close-up view of the pulley end of the support table. [Figure 10]This is an elevational section through a belt pulley. [Figure 11] FIG. 5C is a side cross-sectional view through a distal portion of a catheter such as either of the catheters shown in FIGS. 5A and 5B. [Figure 12A] FIG. 10 is a diagram illustrating a schematic of a force sensor integrated into the sidewall of a catheter. [Figure 12B] FIG. 10 is a diagram illustrating a schematic of a force sensor integrated into the sidewall of a catheter. [Figure 13A] 10A and 10B are diagrams illustrating schematically a sensor for measuring the elastic force in the magnetic coupling between a hub and a corresponding carriage. [Figure 13B] 10A and 10B are diagrams illustrating schematically a sensor for measuring the elastic force in the magnetic coupling between a hub and a corresponding carriage. [Figure 14] FIG. 10 schematically illustrates a dual-encoder torque sensor for use with a catheter of the present disclosure. [Figure 15] 10A-10C illustrate a clot capture and visualization device that may be integrated into the hub and / or connected to a suction line. [Figure 16A] 10A-10C illustrate exemplary control mechanisms for operating interventional devices driven by respective hubs. [Figure 16B] 10A-10C illustrate exemplary control mechanisms for operating interventional devices driven by respective hubs. [Figure 16C] 10A-10C illustrate exemplary control mechanisms for operating interventional devices driven by respective hubs. [Figure 17] FIG. 1 is a side schematic view of an interventional device assembly for supra-aortic access and neurointerventional procedures. [Figure 18A] 1A-1C depict an exemplary sequence of steps for introducing a catheter assembly configured to provide supra-aortic access and neurovascular site access. [Figure 18B]1A-1C depict an exemplary sequence of steps for introducing a catheter assembly configured to provide supra-aortic access and neurovascular site access. [Figure 18C] 1A-1C depict an exemplary sequence of steps for introducing a catheter assembly configured to provide supra-aortic access and neurovascular site access. [Figure 18D] 1A-1C depict an exemplary sequence of steps for introducing a catheter assembly configured to provide supra-aortic access and neurovascular site access. [Figure 18E] 1A-1C depict an exemplary sequence of steps for introducing a catheter assembly configured to provide supra-aortic access and neurovascular site access. [Figure 19] 1A-1C are diagrams illustrating schematically embodiments of mechanical couplings between a driving mechanism and a driven mechanism. [Figure 20A] 1A-1C depict an exemplary sequence of steps for priming a catheter assembly in a stacked configuration. [Figure 20B] 1A-1C depict an exemplary sequence of steps for priming a catheter assembly in a stacked configuration. [Figure 20C] 1A-1C depict an exemplary sequence of steps for priming a catheter assembly in a stacked configuration. [Figure 21A] 1A-1C depict an exemplary sequence of steps for priming a catheter assembly in a stacked configuration. [Figure 21B] 1A-1C depict an exemplary sequence of steps for priming a catheter assembly in a stacked configuration. [Figure 22] FIG. 21B depicts an exemplary test system for the priming process depicted in FIGS. 21A-21B. [Figure 23A] 1A-1C illustrate examples of catheter assemblies. [Figure 23B] 1A-1C illustrate an example of a catheter assembly after a priming procedure. [Figure 23C] 1 is an example of a catheter assembly after a priming procedure involving relative movement between adjacent catheters. [Figure 23D] 23A-23C illustrate the exemplary catheter assembly of FIG. [Figure 23E] 23A-23C illustrate the exemplary catheter assembly of FIG. [Figure 23F] 23A-23C illustrate the exemplary catheter assembly of FIG. [Figure 24] FIG. 1 is a schematic diagram of a control system. DETAILED DESCRIPTION OF THE INVENTION

[0050] In certain embodiments, a system is provided for advancing a guide catheter from femoral or radial artery access into the ostium of one of the great vessels above the aortic arch, thereby achieving supra-aortic access. The surgeon can then take over and advance an interventional device into the cerebral vasculature via the robotically placed guide catheter.

[0051] In some implementations, the system can additionally be configured to robotically obtain intracranial vascular access and to perform aspiration thrombectomy or other neurovascular procedures.

[0052] The drive table can be positioned on or near the patient and can be configured to axially advance, retract, and in some cases rotate and / or laterally deflect two, three, or more different (e.g., concentrically or side-by-side oriented) intravascular devices. The hubs are movable along paths along the surface of the drive table to advance or retract the interventional devices as desired. Each hub can also contain mechanisms for rotating or deflecting the device as desired and is connected to fluid delivery tubing (not shown) of the type conventionally attached to catheter hubs. Each hub can be in electrical communication with an electronic control system via either a hardwired connection, an RF wireless connection, or a combination of both.

[0053] Each hub is independently movable across a surface of a sterile field barrier membrane carried by a drive table. Each hub is releasably magnetically coupled to a unique drive carriage on the table side of the sterile field barrier. The drive system independently moves each hub proximally or distally across the surface of the barrier to move a corresponding interventional device proximally or distally within the patient's vasculature.

[0054] The carriage on the drive table, which magnetically couples with the hub to provide linear motion actuation, is universal. Catheter / guidewire functionality is provided based on what is contained in the hub and shaft design. This allows for the flexibility to configure the system to perform a wide range of procedures using a wide variety of interventional devices on the same drive table. Additionally, the interventional devices and methods disclosed herein can be easily adapted for use with any of a wide variety of other drive systems (e.g., any of a wide variety of robotic surgical drive systems).

[0055] 1 is a schematic perspective view of an interventional setup 10 having a patient support table 12 for supporting a patient 14. An imaging system 16 can be provided along with a robotic interventional device drive system 18 according to the present disclosure.

[0056] Drive system 18 can include, for example, a support table 20 for supporting a guidewire hub 26, an access catheter hub 28, and a guide catheter hub 30. In this context, the term "access" catheter can be any catheter having a lumen with at least one distally or laterally facing distal opening that can be utilized to aspirate thrombus, to provide access for additional devices to be advanced therethrough, or to inject saline, contrast media, or therapeutic agents.

[0057] Depending on the desired clinical procedure, more or fewer interventional device hubs may be provided. For example, in certain embodiments, a diagnostic angiography procedure may be performed using only a guidewire hub 26 and an access catheter hub 28 for driving a guidewire and an access catheter (in the form of a diagnostic angiography catheter), respectively. Multiple interventional devices 22 extend between the support table 20 and (in the illustrated example) a femoral access point 24 on the patient 14. Depending on the desired procedure, access may be achieved by percutaneous or cut-down access to any of various arteries or veins, such as the femoral or radial arteries. Although disclosed herein primarily in the context of neurovascular access and procedures, the robotic drive systems and associated interventional devices can be readily adapted for use in a wide variety of additional medical interventions, such as in the peripheral and coronary arterial and venous vasculature, the gastrointestinal system, the lymphatic system, cerebrospinal fluid lumens or spaces (e.g., the spinal canal, ventricles, and subarachnoid space), the pulmonary airways, treatment sites reached via transurethral or urethral or tubal navigation, or in other hollow organs or structures within the body (e.g., in intracardiac or structural cardiac applications such as valve repair or replacement, or in any endoluminal procedure).

[0058] For example, a display 23 for viewing fluoroscopic images, catheter data (e.g., fiber Bragg grating optical fiber sensor data or other force or shape sensing data), or other patient data, etc. may be carried by support table 20 and / or patient support 12. Alternatively, the physician input / output interface including display 23 may be remote from the patient, e.g., behind radiation shielding, in a different room than the patient, or in a different facility than the patient.

[0059] In the illustrated example, a guidewire hub 26 is carried by the support table 20 and is movable along the table to advance a guidewire into and out of the patient 14. An access catheter hub 28 is also carried by the support table 20 and is movable along the table to advance an access catheter into and out of the patient 14. The access catheter hub can also be configured to rotate the access catheter in response to operation of a rotation control and to laterally deflect a deflectable portion of the access catheter in response to operation of a deflection control.

[0060] FIG. 2 is a longitudinal cross-sectional view that schematically illustrates the motion relationships between a guidewire 27 having two degrees of freedom (axial and rotational), an access catheter 29 having three degrees of freedom (axial, rotational, and lateral deflection), and a guide catheter 31 having one degree of freedom (axial).

[0061] 3A, support table 20 includes a drive mechanism, described in more detail below, for independently driving guidewire hub 26, access catheter hub 28, and guide catheter hub 30. Anti-buckling features 34 can be provided in the proximal anti-buckling zone to resist buckling of the portion of the interventional device spanning the distance between support table 20 and femoral artery access point 24. Anti-buckling features 34 can include a plurality of concentric, telescoping, axially extendable and collapsible tubes through which the interventional device extends.

[0062] Alternatively, one or more proximal segments of the device shaft can be configured with enhanced stiffness to reduce buckling under compression. For example, a proximal reinforced segment can extend distally from the hub for a distance of at least about 5 or 10 centimeters, but typically no more than about 120 or 100 centimeters, to support the device between the hub and the access point 24 on the patient. Reinforcement can be achieved by using metal or polymer tubing or by embedding at least one or two or more axially extending elements, such as elongated wires or ribbons, into the wall of the device shaft. In some implementations, the extending elements are hollow and can protect against wear, buckling, or damage at the input and output of the hub. In some embodiments, the hollow extending elements can be hollow flexible coatings attached to the hub. The hollow extending elements (e.g., hollow flexible coatings) can cover a portion of the device shaft when threaded through the hub. In some embodiments where the hollow extending element is a coating, the coating can be attached to a portion of the hub such that passing the catheter device through the hub 26, 28, or 30 also passes the catheter device through the coating. In some implementations, an anti-buckling device can be placed on or around or surrounding the device shaft to avoid misalignment or insertion angle errors between hubs or between the hub and the insertion point. The anti-buckling device can be laser-cut hypotube, a spring, telescoping tubing, tensioned split tubing, or the like.

[0063] In some implementations, multiple deflection sensors can be placed along the catheter length to identify buckling. Identifying buckling can be performed by detecting distal advancement of the hub while the distal tip of the catheter or interventional device is not being moved. In some implementations, buckling can be detected by detecting an energy load (e.g., due to friction) between the catheter shaft.

[0064] Alternatively, a thin tubular stiffening structure can be embedded within or carried on the exterior of the device wall, such as a tubular polymer extrusion or length of hypotube. Alternatively, a removable stiffening mandrel can be placed within the lumen in the proximal segment of the device and removed proximally following distal advancement of the hub toward the patient access site to prevent buckling of the proximal shaft during distal advancement of the hub. Alternatively, one or more proximal segments of the device shaft can be constructed as a tubular hypotube, which can be machined (e.g., by laser) so that its mechanical properties vary along its length. This proximal segment can be formed from stainless steel, nitinol, and / or cobalt-chromium alloy, optionally in combination with a polymer component capable of providing lubricity and hydraulic sealing. In some embodiments, this proximal segment can be formed from a polymer such as polyetheretherketone (PEEK). Alternatively, the wall thickness or diameter of the interventional device can be increased in the anti-buckling zone.

[0065] In certain embodiments, a device shaft with high stiffness (e.g., axially and torsionally) can provide improved motion transmission from the proximal end of the device shaft to the distal end of the device shaft. For example, the device shaft can be more responsive to motion applied at the proximal end. Such embodiments can be advantageous for robotic actuation in the absence of tactile feedback to the user.

[0066] In some embodiments, a flexible coating can be applied to the device shaft and / or hub to reduce frictional forces between the device shaft and / or hub and a second device shaft as the second device shaft passes through it.

[0067] The interventional device hub can be separated from the support table 20 by a sterile barrier 32. The sterile barrier 32 can comprise a thin plastic film, such as polyethylene terephthalate (PET), polyethylene terephthalate glycol (PETG), polyethylene terephthalate (PETE), high-density polyethylene (HDPE), polyvinyl chloride (PVC), low-density polyethylene (LDPE), polypropylene (PP), polystyrene (PS), or styrene. This allows the support table 20 and associated drive systems to reside on the non-sterile side (below) of the sterile barrier 32. The guidewire hub 26, access catheter hub 28, guide catheter hub 30, and associated interventional devices are all on the sterile side (above) of the sterile barrier 32. The sterile barrier is preferably waterproof and can also serve as a tray used in packaging the interventional devices (discussed further below). The interventional devices can be provided individually or as a coaxially pre-assembled kit, which is shipped and stored in a tray and enclosed in sterile packaging.

[0068] 3B-3F schematically illustrate an alternative sterile barrier in the form of a dual-function sterile barrier for placement on a support table during an interventional procedure and a shipping tray with one or more storage channels for carrying sterile interventional devices. The sterile barrier can also act as a sterile work surface for preparing catheters or other devices during the procedure.

[0069] 3B and 3C, a sterility barrier 32 is shown in the form of a pre-shaped tray to fit over the elongated support table 20. In use, the elongated support table 20 is positioned below the sterility barrier 32. The sterility barrier 32 extends between a proximal end 100 and a distal end 102 and includes an upper support surface 104 for supporting an interventional device hub. In one implementation, the support surface 104 has an axial length greater than the length of the intended interventional device in a linear drive configuration.

[0070] The length of the support surface 104 will typically be at least about 100 centimeters and will be in the range of about 100 centimeters to about 2.7 meters. Shorter lengths can be utilized in systems configured to advance the drive coupler along an arcuate path. In some embodiments, two or more support surfaces can be used in place of a single support surface 104. The two or more support surfaces can have a combined length between 100 centimeters and about 2.7 meters. The width of the linear drive table is preferably no more than about 30 centimeters to about 80 centimeters.

[0071] At least a first channel 106 may be provided, extending axially for at least a portion of the length of the support table 20. In the illustrated implementation, the first channel 106 extends the entire length of the support table 20. Preferably, the first channel 106 has a length sufficient to hold an interventional device and a width and depth sufficient to hold a corresponding hub (e.g., by providing lateral support to prevent dislodgement of the hub when force is applied to the hub). The first channel 106 is defined in the floor 108, the outer sidewall 110, and the inner sidewall 111 and forms an upwardly facing concave surface. Optionally, a second channel 112 may be provided. The second channel 112 may be located on the same or opposite side of the upper support surface 104 from the first channel 106. Two, three or more additional recesses, such as additional channels or wells, can be provided to hold additional medical devices or supplies that may be useful during the interventional procedure, as well as to collect fluids and act as washing reservoirs for the catheter and related devices.

[0072] 3D, guide catheter hub 30 is shown positioned on upper support surface 104 and magnetically coupled to a corresponding coupler holding a drive magnet positioned below sterile barrier 32. Access catheter hub 28 and access catheter 29, as well as guidewire hub 26 and guidewire 27, are shown to reside within first channel 106, e.g., prior to introduction through guide catheter 31 or following removal from guide catheter 31.

[0073] An interventional device can be positioned in the channel 106 and enclosed within a sterile barrier for shipping. At the clinical site, the upper panel of the sterile barrier can be removed, or the tubular sterile barrier packaging can be opened and axially removed from the support table 20 and sterile barrier 32 assembly, exposing the sterile top side of the sterile barrier tray and any contained interventional device. The interventional device can be carried separately in the channel or pre-assembled into an access or treatment assembly, which are discussed in additional detail below.

[0074] Figures 3D-3F illustrate the support table with the sterile barrier in place, and Figure 3E illustrates the interventional device configured into the access assembly for aortic access following coupling of the access assembly to a corresponding carriage below the sterile barrier. The access assembly can be pre-assembled with the guidewire fully advanced through the access catheter and the access catheter fully advanced through the guide catheter. In embodiments where the access catheter or other catheters are pre-shaped (i.e., not pre-curved or straight), the guidewire and / or outer catheter can be positioned so that the relatively stiff sections do not overlap the curved, stiffer sections of the pre-shaped catheter, e.g., to avoid creep or straightening of the pre-shaped catheter and / or to avoid introducing a curve into an otherwise straight catheter. The access assembly can be lifted from the channel 106 and positioned on the support surface 104 for coupling to the respective drive magnets and introduction into the patient. The guide catheter hub 30 is the distal-most hub. The access catheter hub 28 is positioned proximally to the guide catheter hub to allow the access catheter 29 to extend distally through the guide catheter. The guidewire hub 26 is positioned proximally most to allow the guidewire 27 to be advanced through the access catheter 29 and the guide catheter 31.

[0075] The treatment assembly is shown in FIG. 3F following its introduction through the guide catheter 31 used to achieve supra-aortic access. In this implementation, the guide catheter 31 remains the most distal of the interventional devices. A first treatment catheter 120 and corresponding hub 122 are shown extending through the guide catheter 31. An optional second treatment catheter 124 and corresponding hub 126 are shown extending through the first treatment catheter 120. A guidewire 27 extends through at least a portion of the second treatment catheter 124 in a rapid exchange version of the second treatment catheter 124, or through the entire length of the second treatment catheter 124 in an over-the-wire implementation.

[0076] As discussed in more detail in connection with FIG. 17 , a multi-catheter stack can be utilized to achieve both access and endovascular procedures without the need for catheter exchange. This can be accomplished with either manually or robotically driven procedures. In one example, the guide catheter 31 can include a catheter having an inner diameter of at least about 0.08 inches, and in one implementation, an inner diameter of about 0.088 inches. The first treatment catheter 120 can include a catheter having an inner diameter in the range of about 0.065 inches to about 0.075 inches, and in one implementation, the catheter 120 has an inner diameter of about 0.071 inches. The second treatment catheter 124 can be an access catheter with an OD sized to allow advancement through the first treatment catheter 120. The second treatment catheter can be steerable and include a deflection control 2908 configured to laterally deflect the distal end of the catheter. The second treatment (access) catheter can also have an inner lumen that is sized to allow an appropriately sized guidewire to remain inside the second treatment catheter while contrast injection is performed through the second treatment catheter.

[0077] In certain embodiments, catheter 31 can be a "large bore" access or guide catheter having a diameter of at least about 0.075 or at least about 0.080 inches. Catheter 120 can be an aspiration catheter having a diameter in the range of about 0.060 inches to about 0.075 inches. Catheter 124 can be a steerable catheter with a deflectable distal tip having a diameter in the range of about 0.025 inches to about 0.050 inches. Guidewire 27 can have a diameter in the range of about 0.014 inches to about 0.020 inches. In one example, catheter 31 can have a diameter of about 0.088 inches, catheter 120 can have a diameter of about 0.071 inches, catheter 124 can have a diameter of about 0.035 inches, and guidewire 27 can have a diameter of about 0.018 inches.

[0078] In one commercial implementation, a pre-assembled access assembly (guide catheter, access catheter, and guidewire) can be carried in a first channel on the sterile barrier tray, and a pre-assembled treatment assembly (one or two treatment catheters and guidewire) can be carried in the same or a different second channel on the sterile barrier tray. One, two, or more additional catheters or interventional tools can also be provided, depending on potential needs during the interventional procedure.

[0079] 3G-3K illustrate an alternative sterility barrier embodiment having a convex drive surface (e.g., a convex crowned road drive surface). FIG. 3G is a cross-sectional view of sterility barrier 232. Sterility barrier 232 includes a convex upper support surface 204. Fluid channels 205 and 207 are positioned laterally and below support surface 204 for self-clearing or draining fluid from support surface 204 (e.g., during an interventional procedure). Fluid channels 205 and 207 can extend axially for at least a portion of the length of the sterility barrier.

[0080] 3I, 3J, and 3K illustrate a cross-sectional perspective view, a cross-sectional view, and a top cross-sectional view, respectively, of the proximal end of sterility barrier 232. As shown in FIGS. 3I-3K, sterility barrier 232 can include a trough 240 in communication with fluid channels 205 and 207. Trough 240 can receive fluid from channels 205 and 207 (e.g., during an interventional procedure). Trough 240 can be positioned at least partially below fluid channels 205 and 207 such that fluid in channels 205 and 207 flows into trough 240. In certain embodiments, fluid channels 205 and 207 can be angled relative to a horizontal plane (e.g., can descend from the end of the channel farthest from trough 240 into trough 240) such that fluid in channels 205 and 207 is directed toward trough 240. For example, channels 205 and 207 can increase in depth from the ends of the channels farthest from trough 240 to trough 240. Alternatively, sterility barrier 232 and / or support table can be positioned at an angle relative to a horizontal plane during part or all of the interventional procedure, such that the ends of channels 205 and 207 farthest from trough 240 are positioned higher than trough 240. For example, sterility barrier 232 and / or support table can be constructed or positioned in an angled arrangement such that the ends of sterility barrier 232 and / or support table opposite trough 240 are positioned higher than trough 240. Alternatively or additionally, the drive mechanism may be capable of temporarily tilting the sterile barrier 232 and / or support table (e.g., by lifting the end of the sterile barrier and / or support table opposite the trough 240 or by lowering the end of the sterile barrier 232 and / or support table on which the trough 240 is positioned) so that the end of the sterile barrier 232 and / or support table opposite the trough 240 is positioned higher than the trough 240, allowing the fluid in the channels 205 and 207 to flow into the trough 240.

[0081] The trough 240 can include a drain hole 242. The trough 240 can be shaped, sized, and / or otherwise configured to allow fluid in the trough 240 to empty into the drain hole 242. The drain hole 242 can include tubing, a barb fitting, and / or an on-off valve for removal of fluid from the trough 240. As shown in FIGS. 3I-3K, the trough 240 can be positioned at the proximal end of the sterility barrier 232. In an alternative embodiment, the trough 240 can be positioned at the distal end of the sterility barrier 232. In some embodiments, the sterility barrier 232 can include a first trough 240 at the proximal end and a second trough 240 at the distal end. In some embodiments, the trough 240 can also be used as a washing reservoir.

[0082] The first channel 206 can extend axially for at least a portion of the length of the sterility barrier 232. The channel 206 can have a length sufficient to hold an interventional device and a width and depth sufficient to hold a corresponding hub (e.g., by providing support to prevent the hub from dislodging when force is applied to the hub). Optionally, a second channel 212 can be provided. The second channel 212 can be positioned on the same or opposite side of the upper support surface 204 from the first channel 206. FIG. 3G illustrates the channel 212 positioned on the opposite side of the support surface 204 from the channel 206. FIG. 3H is a cross-sectional view illustrating an alternative embodiment of the sterility barrier 232 in which the channel 212 is on the same side of the support surface 204 as the channel 206.

[0083] 3G and 3H, channels 206 and 212 can have a generally triangular, wedge-shaped, or otherwise angled cross-section to hold the hub at an angle relative to the horizontal plane. Holding the hub at an angle relative to the horizontal plane can allow for a smaller width of sterility barrier 232.

[0084] Two, three or more additional recesses, such as additional channels or wells, can be provided to hold additional medical devices or supplies that may be useful during the interventional procedure, as well as to collect fluids and act as washing reservoirs for the catheter and related devices.

[0085] In some embodiments, the sterility barrier 232 can include one or more structural ribs 236. The sterility barrier 232 can further include one or more frame support bosses 228 and 238.

[0086] In the embodiment of the sterility barrier 232 shown in FIG. 3G, the width x1 can be 14 inches wide, approximately 14 inches wide, between 12 inches and 16 inches wide, between 10 inches and 18 inches wide, or any other suitable width. In the embodiment of the sterility barrier 232 shown in FIG. 3H, the width x1 can be 15 inches wide, approximately 15 inches wide, between 13 inches and 17 inches wide, between 11 inches and 19 inches wide, or any other suitable width. The height y1 of the support surface 204 can be 0.125 inches high, approximately 0.125 inches high, between 0.1 inches and 0.15 inches high, or any other suitable height. In some embodiments, the support surface 204 can be recessed from the top surface 233 of the sterility barrier 232. The height y2 between the bottom and top surface 233 of support surface 204 can be 0.5 inches high, approximately 0.5 inches high, between 0.25 inches and 0.75 inches high, or any other suitable height. The width x2 from the lateral edge of channel 205 to the lateral edge of channel 207 can be 5 inches wide, approximately 5 inches wide, between 4 inches and 6 inches wide, or any other suitable width. The width x3 of support surface 204 can be 4 inches wide, approximately 4 inches wide, between 3 inches and 5 inches wide, or any other suitable width. The height y3 of channel 206 and / or channel 212 can be 1.5 inches high, approximately 1.5 inches high, between 1 inch and 2 inches high, or any other suitable height. The width x4 of channel 206 and / or channel 212 can be 3 inches wide, approximately 3 inches wide, between 2 inches and 4 inches wide, or any other suitable width. Channel 206 and / or channel 212 can be defined by an arc angle α of 90°, an arc angle α of approximately 90°, an arc angle α of between 80° and 100°, or any other suitable angle, and by a radius of curvature of 0.125 inches, a radius of curvature of approximately 0.125 inches, a radius of curvature between 0.1 inches and 0.15 inches, or any other suitable radius of curvature.In certain embodiments, an arc angle α of 90° or approximately 90° can be used to hold a hub having a rectangular or generally rectangular cross-section. Support surface 204 can be defined by a radius of curvature of 13 inches, approximately 13 inches, between 11 and 15 inches, or any other suitable radius of curvature. Channel 205 and / or channel 207 can be defined by a radius of curvature of 0.25 inches, approximately 0.25 inches, between 0.15 and 0.35 inches, or any other suitable radius of curvature.

[0087] 3L and 3M depict exemplary dimensions of a hub 250 that may be used with the sterility barrier 232 shown in FIGS. 3G-3K. The hub 250 can be any of the hubs described herein. In certain embodiments, the hub 250 can have a width w1 of 3.75 inches, a width w1 of approximately 3.75 inches, a width w1 of between 3.25 inches and 4.25 inches, or any other suitable width. The hub 250 can have a height h1 of 1.5 inches, a height h1 of approximately 1.5 inches, a height h1 of between 1.25 inches and 1.75 inches, or any other suitable height. Alternatively, the hub 250 can have a height h2 of 2 inches, a height h2 of approximately 2 inches, a height h2 of between 1.75 inches and 2.25 inches, or any other suitable height. In some embodiments, the hub 250 can have a length L1 of 2.5 inches, a length L1 of approximately 2.5 inches, a length L1 of between 2 and 3 inches, or any other suitable length. Alternatively, the hub 250 can have a length L2 of 4 inches, a length L2 of approximately 4 inches, a length L2 of between 3.25 and 4.75 inches, or any other suitable length.

[0088] In some embodiments, the upper surface of the support table can include surface features that generally correspond to those of the sterility barrier 232. For example, the support table can include a convex surface configured to correspond to the shape, size, and location of the support surface 204 and / or one or more recesses configured to correspond to the shape, size, and location of the channels 205 and 207.

[0089] In alternative embodiments, the planar support surface (e.g., support surface 104 of sterility barrier 32) can be positioned at an angle relative to the horizontal plane to facilitate drainage of fluids. In some embodiments, the sterility barrier and / or support table can be positioned at an angle relative to the horizontal plane to facilitate drainage of fluids during part or all of an interventional procedure. For example, the sterility barrier and / or support table can be constructed or positioned in an angled arrangement to facilitate drainage of fluids (e.g., one lateral side of the planar support surface is positioned higher than the other lateral side of the planar support surface, the proximal end is higher than the distal end, or the distal end is higher than the proximal end). Alternatively or additionally, the drive mechanism may temporarily tilt the sterile barrier and / or support table (e.g., so that one lateral side of the planar support surface is positioned higher than the other lateral side of the planar support surface, so that the proximal end is higher than the distal end, or so that the distal end is higher than the proximal end) to facilitate fluid drainage. For example, the drive mechanism may raise or lower one lateral side of the sterile barrier and / or support table, the proximal end of the sterile barrier and / or support table, and / or the distal end of the sterile barrier and / or support table.

[0090] In certain embodiments, the support surface (e.g., support surface 104 of sterile barrier 32) can be positioned in a vertical configuration rather than the horizontal configuration shown in, for example, FIGS. 3A-3F. For example, support surface 104 can be positioned approximately 90 degrees (or any other suitable angle) from the horizontal plane (e.g., rotated 90 degrees about the long axis of support surface 104 relative to the embodiment shown in FIGS. 3A-3F). The vertical configuration can provide easier interaction with drive system 18 by the physician. The vertical configuration can also provide a lower axis of catheter travel closer to the patient without adding standoff height to drive system 18.

[0091] In some embodiments, drive system 18 can be positioned at an angle relative to a horizontal plane to facilitate fluid drainage during part or all of an interventional procedure. For example, drive system 18 can be constructed or positioned in an angled arrangement (e.g., one lateral side of the planar support surface is positioned higher than the other lateral side of the planar support surface, the proximal end is higher than the distal end, or the distal end is higher than the proximal end) to facilitate fluid drainage. Alternatively or additionally, the drive mechanism can temporarily tilt drive system 18 to facilitate fluid drainage (e.g., one lateral side of drive system 18 is positioned higher than the other lateral side of drive system 18, the proximal end is higher than the distal end, or the distal end is higher than the proximal end). For example, the drive mechanism can raise or lower one lateral side of the system 18, the proximal end of the drive system 18, and / or the distal end of the drive system 18. In some embodiments, the drive system 18 can be angled so that it extends at an angle away from the access point 24 (e.g., so that the proximal end is higher than the distal end), for example, to allow clearance for the patient's feet.

[0092] Referring to FIG. 4 , the hub 36 can represent any of the hubs previously described. The hub 36 includes a housing 38 extending between a proximal end 40 and a distal end 42. An interventional device 44 (which can be any of the interventional devices disclosed herein) extends distally from the hub 36 into the patient 14 (not shown). The hub adapter 48, or carriage, acts as a shuttle by advancing proximally or distally along a track in response to operator commands or controller manipulation. The hub adapter 48 includes at least one drive magnet 67 configured to couple with a driven magnet 69 carried by the hub 36. This provides a magnetic coupling between the drive magnet 67 and the driven magnet 69 through the sterile barrier such that the hub 36 is moved across the top of the sterile barrier 32 in response to movement of the hub adapter 48 outside the sterile field. Movement of the hub adapter is driven by a drive system carried by the support table and described in additional detail below. The hub adapter is capable of acting as a robotic drive for an interventional device coupled to it.

[0093] To reduce friction within the system, the hub 36 can be provided with at least a first roller 53 and a second roller 55, which can be in the form of a wheel, a rotatable ball, or a drum. The rollers space the sterility barrier from the surface of the driven magnet 69 by at least about 0.008 inches, and typically about 0.03 inches or less. In some implementations, the space is within a range of about 0.010 inches to about 0.016 inches. The space between the drive magnet 67 and the driven magnet 69 is typically about 0.15 inches or less, and in some implementations, about 0.10 inches or less, such as within a range of about 0.085 inches to about 0.090 inches. The hub adapter 48 may likewise be provided with at least a first hub adapter roller 59 and a second hub adapter roller 63, which may be positioned opposite the respective first roller 53 and second roller 55, as shown in FIG. 4.

[0094] 6, one example of a low-profile linear drive support table 20 is illustrated schematically. The support table 20 includes an elongated frame 51 extending between a proximal end 52 and a distal end 54. At least one support table support 56 is provided for stabilizing the support table 20 relative to a patient (not shown). The support 56 may include one or more legs, or preferably, articulating arms, that are configured to allow movement and positioning of the frame 51 on or adjacent to the patient.

[0095] One example of the linear drive table 20 shown in FIG. 7 includes three individual drives. However, two drives or four or more drives (e.g., up to eight drives) can be included depending on the desired clinical performance. A first drive pulley 58 is engaged with a first drive belt 60. A first carriage bracket 61 is fixed to the first drive belt 60 such that rotation of the first drive pulley 58 causes rotation of the first drive belt 60 through an elongated closed-loop path. The first carriage bracket 61 can be advanced proximally or distally along the longitudinal axis of the support table 20 depending on the direction of rotation of the drive pulley 58. In the illustrated implementation, the drive pulley 58 is provided with surface structure, such as a plurality of drive pulley teeth 62, for engaging complementary teeth on the first drive belt 60.

[0096] The second drive pulley 64 can be engaged with a second drive belt 66, which is configured to axially move a second carriage bracket 68 along an axial path over the support table 20. The third drive pulley 70 can be configured to drive a third drive belt 72 to axially advance a third carriage bracket 73 along the support table 20. Each of the carriage brackets can be provided with a drive magnet assembly, not shown in FIG. 7 but previously discussed, to form a coupler for magnetically coupling to a corresponding driven magnet in the hub of an interventional device as discussed.

[0097] A detailed view of the drive system is shown schematically in FIG. 8 . A drive support 74 can be carried by the frame 51 for supporting the drive assembly. The second drive pulley 64 is shown in elevational section as being rotationally driven by a motor 75 via a rotatable shaft 76. The rotatable shaft 76 can be rotatably carried by the support 74 via a first bearing 78, a shaft coupling 80, and a second bearing 79. The motor 75 can be stabilized by a motor bracket 82 connected to the drive support 74 and / or the frame 51. The belt drive assemblies for the first drive belt 60 and the third drive belt 72 can be similarly constructed and will not be further detailed herein. In some embodiments, the drive system described herein can be a foldable rack-and-pinion drive table system. In such embodiments, the motor 75 can be attached to the carriage and move with the carriage.

[0098] 9 and 10, each of the first, second, and third drive belts extends around a corresponding first idler pulley 84, a second idler pulley 86, and a third idler pulley 88. Each idler pulley may be provided with a corresponding tensioning bracket 90 configured to adjust the idler pulley proximally or distally to adjust the tension of the respective belt. Accordingly, each tensioning bracket 90 is provided with a tensioning adjustment portion 92, such as a rotatable screw or the like.

[0099] As seen in FIG. 10, the second idler pulley 86 may be carried, for example, by a rotatable shaft 94 that is rotatably fixed relative to the mounting bracket by a first bearing 96 and a second bearing 98.

[0100] For example, any of the catheters illustrated in Figures 5A, 5B, or 11 generally include an elongated tubular body extending between a proximal end and a distal working end. The length and diameter of the tubular body depend on the desired application. For example, lengths in the area of about 90 centimeters to about 195 centimeters or more are typical for use in percutaneous transluminal coronary applications with femoral access. Intracranial or other applications may require different catheter shaft lengths depending on the vascular access site.

[0101] Any of the catheters disclosed herein can be provided with a beveled distal tip. Referring to Figure 11, a distal catheter tip 1150 includes a tubular body 1152, which includes an advancement segment 1154, a marker band 1156, and a proximal segment 1158. An inner tubular liner 1160 can extend throughout the length of the distal catheter tip 1150 and can include dip-coated or extruded PTFE or other lubricious material.

[0102] A reinforcing element 1162, such as a braid and / or spring coils, is embedded within an outer jacket 1164, which may extend the entire length of the catheter.

[0103] The advancing segment 1154 terminates distally in an angled surface 1166 and provides a leading sidewall portion 1168 having a length measured between the distal end 130 of the marker band 1156 and a distal tip 1172. In some embodiments, the entire distal tip can be shaped to avoid snagging of the tip in the area of an arterial bifurcation. The trailing sidewall portion 1174 of the advancing segment 1154 has an axial length that, in the illustrated embodiment, is approximately equal to the axial length of the leading sidewall portion 1168 as measured approximately 180 degrees around the catheter from the leading sidewall portion 1168. The leading sidewall portion 1168 can have an axial length in the range of about 0.1 millimeter to about 5 millimeters, and typically in the range of about 1 millimeter to 3 millimeters. The trailing sidewall portion 1174 can be equal to or at least about 0.1 or 0.5 or 1 millimeter or 2 millimeters or more shorter than the axial length of the leading sidewall portion 1168 depending on the desired performance.

[0104] The angled surface 1166 is inclined at an angle A ranging from about 45 degrees to about 80 degrees from the longitudinal axis of the catheter. For certain implementations, the angle is ranging from about 55 degrees to about 65 degrees from the longitudinal axis of the catheter. In one implementation, angle A is about 60 degrees. One result of an angle A less than 90 degrees is that the major axis of the distal port area is lengthened, which can increase the surface area of the port and enhance clot aspiration or retention. Compared to the surface area of a circular port (where angle A is 90 degrees), the area of the angled port is generally at least about 105 percent and not more than about 130 percent, and in some implementations, is in the range of about 110 percent to about 125 percent, and in one example, is about 115 percent of the area of the corresponding circular port (where angle A is 90 degrees).

[0105] In the illustrated embodiment, the axial length of the advancement segment is substantially constant around the circumference of the catheter, such that the angled surface 1166 is approximately parallel to the distal surface 1176 of the marker band 1156. The marker band 1156 has a proximal surface that is approximately transverse to the longitudinal axis of the catheter, creating a right-angled trapezoidal configuration for the marker band 1156 in side view. The short sidewall portion 1178 is rotationally aligned with the trailing sidewall portion 1174 and has an axial length in the range of about 0.2 millimeters to about 4 millimeters, with an axial length of about 0.5 millimeters to about 2 millimeters being typical. The opposing long sidewall portion 1180 is rotationally aligned with the leading sidewall portion 1168. The long sidewall 1180 of the marker band 1156 is generally at least about 10 or 20 percent longer than the short sidewall 1178, and can be at least about 50, 70, or 90 percent or more longer than the short sidewall 1178, depending on the desired performance. Generally, the long sidewall 1180 will have a length of at least about 0.5 millimeters or 1 millimeter and less than about 5 millimeters or less than 4 millimeters.

[0106] The marker band can be a continuous annular structure or can have at least one, and optionally two or three or more, axially extending slits throughout its length. The slits can be located on or between the short side wall 1178 or the long side wall 1180 depending on the desired bending characteristics. The marker band can comprise any of a variety of radiopaque materials, such as a platinum / iridium alloy, and the wall thickness is preferably about 0.003 inches or less, and in one implementation, about 0.001 inches.

[0107] The fluoroscopic appearance of the marker bands can be unique or individual for each catheter size or type when multiple catheters are utilized, such that the marker bands can be distinguishable from one another by a software algorithm. Distinguishing the marker bands of multiple catheters can be advantageous when multiple catheters are used together, for example, in a multi-catheter assembly or stack as described herein. In some embodiments, the marker bands of the catheters can be configured to allow a software algorithm to detect catheter tip movement.

[0108] The marker band zone of the assembled catheter can have a relatively high bending stiffness and high crush strength (e.g., at least about 50 percent or at least about 100 percent less than the proximal segment 1158, but not more than about 200 percent less than the proximal segment 1158). The high crush strength can provide radial support to the adjacent advancement segment 1154, particularly the leading sidewall portion 1168, and promote the distal tip 1172 to function as an atraumatic bumper during transluminal advancement and resist collapse under vacuum. The proximal segment 1158 preferably has a lower bending stiffness than the marker band zone, and the advancement segment 1154 preferably has an even lower bending stiffness and crush strength than the proximal segment 1158.

[0109] The advancement segment 1154 can include a distal extension of an outer tubular jacket 1164 and optionally an inner liner 1160 without any other internal support structure distal to the marker band 1156. The outer jacket 1164 can include an extruded polyurethane such as Tecothane®. The advancement segment 1154 can have a bending stiffness and radial crush stiffness that are about 50 percent or less, and in some implementations about 25 percent or less, 15 percent or less, or 5 percent or less, than the corresponding values of the proximal segment 1158.

[0110] The catheter can further include an axial tension element or support, such as a ribbon or one or more filaments or fibers, to increase tension resistance and / or affect bending characteristics in the distal zone. The tension support can include one or more axially extending monostrand or multistrand filaments. One or more tension elements 1182 can be axially positioned inside the catheter wall near the distal end of the catheter. The one or more tension elements 1182 can function as tension supports and resist tip dislodgement or stretching of the catheter wall under tension (e.g., when the catheter is retracted proximally through a twisted outer catheter or tortuous or narrowed vasculature).

[0111] At least one of the one or more tension elements 1182 can extend proximally along the length of the catheter wall from within about 1.0 centimeter of the distal end of the catheter, to less than about 10 centimeters from the distal end of the catheter, to less than about 20 centimeters from the distal end of the catheter, to less than about 30 centimeters from the distal end of the catheter, to less than about 40 centimeters from the distal end of the catheter, or to less than about 50 centimeters from the distal end of the catheter.

[0112] One or more tension elements 1182 can have a length greater than or equal to about 40 centimeters, greater than or equal to about 30 centimeters, greater than or equal to about 20 centimeters, greater than or equal to about 10 centimeters, or greater than or equal to about 5 centimeters.

[0113] At least one of the one or more tension elements 1182 can extend over at least about the most distal 50 centimeters of the length of the catheter, at least about the most distal 40 centimeters of the length of the catheter, at least about the most distal 30 centimeters, or 20 centimeters, or 10 centimeters of the length of the catheter.

[0114] In some implementations, the tension element extends proximally from the distal end of the catheter along the length of the coil 24, terminating proximally within about 5 centimeters or 2 centimeters or less on either side of the transition between the distal coil and the proximal braid. The tension element can terminate at the transition without overlapping the braid.

[0115] One or more tension elements 1182 can be located near or radially outside the inner liner 1160. One or more tension elements 1182 can be located near or radially inside the braid and / or coil. One or more tension elements 1182 can be carried between the inner liner 1160 and the helical coil and can be secured to the surface of the inner liner or other underlying layer by adhesive before the addition of the next outer adjacent layer, such as a coil. Preferably, the tension elements 1182 are secured to the marker band 1156 by adhesive or mechanical interference. In one implementation, the tension elements 1182 extend distally over and beyond the marker band on a first (e.g., inner) surface of the marker band, then wrap around the distal end of the marker band, extend along a second (e.g., outer) surface in either or both a proximal angled direction or a circumferential direction, and completely wrap around the marker band.

[0116] When two or more tension elements 1182 or filament bundles are circumferentially spaced apart within the catheter wall, the tension elements 1182 can be positioned in a radially symmetric manner. For example, the angle between two tension elements 1182 relative to the radial center of the catheter can be approximately 180 degrees. Alternatively, depending on the desired clinical performance (e.g., flexibility, trackability), the tension elements 1182 can be positioned in a radially asymmetric manner. The angle between any two tension elements 1182 relative to the radial center of the catheter can be less than or equal to approximately 180 degrees, less than or equal to approximately 165 degrees, less than or equal to approximately 135 degrees, less than or equal to approximately 120 degrees, less than or equal to approximately 90 degrees, less than or equal to approximately 45 degrees, or less than or equal to approximately 15 degrees.

[0117] The one or more tension elements 1182 can 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 can comprise a single fiber or a multi-fiber bundle, and the fiber or bundle can have a round or rectangular (e.g., ribbon) cross-section. The terms fiber or filament do not convey composition; they can comprise any of a variety of high tensile strength polymers, metals, or alloys, depending on design considerations such as the desired tensile fracture limit and wall thickness. The cross-sectional dimension of the one or more tension elements 1182, as measured radially, can be approximately 2 percent or less, 5 percent or less, 8 percent or less, 15 percent or less, or 20 percent or less of that of the catheter 10.

[0118] The cross-sectional dimension of one or more tension elements 1182, as measured radially, can be about 0.03 millimeters (about 0.001 inches) or less, about 0.0508 millimeters (about 0.002 inches) or less, about 0.1 millimeters (about 0.004 inches) or less, about 0.15 millimeters (about 0.006 inches) or less, about 0.2 millimeters (about 0.008 inches) or less, or about 0.38 millimeters (about 0.015 inches) or less.

[0119] The one or more tensioning elements 1182 can increase the tensile strength of the distal zone of the catheter before failure under tension (e.g., marker band detachment) to at least about 1 lb, at least about 2 lb, at least about 3 lb, at least about 4 lb, at least about 5 lb, at least about 6 lb, at least about 7 lb, at least about 8 lb, or at least about 10 lb or more.

[0120] Depending on the desired data, any of a variety of sensors can be provided on either the catheter, hub, carriage, or table. For example, in some implementations, it may be desirable to measure axial tension or compression applied to the catheter, such as along a force-sensing zone. The distal end of the catheter would be made of a similar construction as shown in FIG. 11 with a helical coil distal section. However, instead of using a single helical coil of nitinol wire, first conductor 140 and second conductor 142 are wound into intertwined helical coils and are electrically isolated from each other, for example, by the plastic / resin of the tubular body. See FIG. 12A. Each coil is in electrical communication with the proximal hub by a unique electrical conductor, such as a conductive trace or a proximal extension of the wire.

[0121] This construction of dual, electrically isolated helical coils creates a capacitor, roughly equivalent to two plates of Nitinol with a plastic layer between them, as shown in FIG. 12B. Capacitance is inversely proportional to the distance between the wires. The only variable that will vary is d (the distance between the plates). When an axial compressive force is applied to the catheter, the wires (e.g., conductors 140 and 142) will move closer together, thus increasing the capacitance. When an axial tensile force is applied, the wires will move further apart, decreasing the capacitance. This capacitance can be measured at the proximal end of the catheter, providing a measure of the force on the helical capacitor. Although called a capacitor, the sensor is measuring the electrical interaction between the two coils of wire. There can be a measurable change in inductance or other resulting change due to the applied axial force.

[0122] At least a first helical capacitor can have at least one, five, ten, or more complete turns of each wire. The capacitor can be positioned within the distal-most 5, 10, or 20 centimeters of the catheter body to sense forces experienced at the distal end. At least a second capacitor can be provided within the proximal-most 5, 10, or 20 centimeters of the catheter body to sense forces experienced at the proximal end of the catheter.

[0123] It may also be desirable to measure the elastic force across the magnetic linkage between the hub and the corresponding carriage, using the magnetic linkage's natural springiness (compliance) to measure the force applied to the hub. The magnetic linkage between the hub and carriage creates a spring. When a force is applied to the hub, the hub will move a small amount relative to the carriage. See FIG. 13A. In robotics, this is called a series elastic actuator. This property can be used to measure the force applied to the hub from the carriage. To measure the force, the relative distance between the hub and carriage (dx shown in FIG. 13A) is determined to characterize some effective spring constant k between the two components. See FIG. 13B.

[0124] Relative distance can be measured in several different ways. One method for measuring the relative distance between the hub and carriage is with a magnetic sensor (e.g., a Hall effect sensor between the hub and carriage). A magnet is mounted on either the hub or the carriage, and a corresponding magnetic sensor is mounted on the other device (carriage or hub). The magnetic sensor can be a Hall effect sensor, a magnetoresistive sensor, or another type of magnetic field sensor. Generally, multiple sensors can be used to increase the reliability of the measurement. This reduces noise and reduces interference from external magnetic fields.

[0125] Other non-contact distance sensors can also be used. These include optical, inductive, and capacitive sensors. Optical sensors would preferably be configured in a manner that avoids the accumulation of blood or other fluids at the interface between the hub and the carriage. In some implementations, for example, wireless (i.e., inductive) power can be used to transduce movement and / or transfer information across the sterile barrier between the drive carriage and the hub.

[0126] The magnetic coupling between the hub and carriage has a shear or axial break threshold, which can be approximately 300 grams or 1000 grams or more. The processor can be configured to compare the axial force applied to the catheter to a preset axial trigger force that, if applied to the catheter, is perceived to create a risk to the patient. If the trigger force is reached, the processor can be configured to generate a response, such as visual, auditory, or tactile feedback to the physician, and / or to slow and stop further advancement of the catheter until a reset is achieved. An override feature can be provided so that the physician can choose to continue advancing the catheter at a force higher than the trigger force in situations where the physician believes incremental force is justified.

[0127] Force and / or torque sensing optical fibers (e.g., fiber Bragg grating (FBG) sensors) can be incorporated into the catheter sidewall or, alternatively, integrated into the guidewire to measure force and / or torque at various locations along the catheter shaft. The fiber measures axial strain, which (when helically wound) can be converted to axial force or torque. At least a first FBG sensor can be integrated into a distal, proximal, and / or intermediate sensing zone on the catheter or guidewire to measure force and / or torque in the vicinity of the sensor.

[0128] It may also be desirable to understand the three-dimensional configuration of a catheter or guidewire during and / or following transvascular placement. Shape-sensing optical fibers, such as arrays of FBG fibers, are used to sense the shape of catheters and guidewires. By using multiple force-sensing fibers at known distances from each other, the shape along the length of the catheter / guidewire can be determined.

[0129] Resistive strain gauges can be integrated into the body of the catheter or guidewire to measure force or torque, such as at the distal tip and / or proximal end of the device.

[0130] Measurements of the force and / or torque applied to the catheter or guidewire shaft can be used to determine applied force and / or torque above a safety threshold. A warning can be provided to the user when the applied force and / or torque exceeds the safety threshold. Measurements of the applied force and / or torque can also be used to provide feedback related to better catheter manipulation and control. Measurements of the applied force and / or torque can also be used in conjunction with processed fluoroscopic imaging information to determine or characterize distal tip motion.

[0131] The absolute position of the hub (and corresponding catheter) along the length of the table can be determined in a variety of ways. For example, a non-contact magnetic sensor can be configured to measure the position of the hub directly through the sterile barrier. The same type of sensor can also be configured to measure the position of the carriage. Each hub can have at least one magnet attached to it. The robotic table will have a corresponding linear array of magnetic sensors spanning the length of the table. A processor can be configured to determine the location of the magnet along the length of the linear sensor array and display the axial position information to the physician.

[0132] Alternatively, the foregoing can be accomplished using non-contact inductive sensors to directly measure the position of the hub through the sterile barrier. Each hub or carriage can be provided with an inductive "target" therein. The robot table can be provided with an inductive sensing array throughout the working length of the table. As a further alternative, an absolute linear encoder can be used to directly measure the linear position of the hub or carriage. The encoder can use any of a variety of different technologies, including optical, magnetic, inductive, and capacitive methods.

[0133] In one implementation, a passive (no electrical connection) target coil can be carried by each hub. A linear printed circuit board (PCB) can run the entire working length of the table (e.g., at least about 1.5 meters to about 1.9 meters) configured to ping an interrogator signal that stimulates a return signal from the passive coil. The PCB is configured to identify the return signal and its location.

[0134] The axial position of the carriage can be determined using a multi-turn rotary encoder to measure the rotational position of the pulley, which directly correlates to the linear position of the carriage. Direct measurement of the carriage location can alternatively be achieved by recording the number of steps commanded to a stepper motor to measure the rotational position of the pulley, which directly correlates to the linear position of the carriage.

[0135] The location of the catheter and guidewire within the anatomy can also be determined by processing fluoroscopic images with machine vision to, for example, determine distal tip position, distal tip orientation, and / or guidewire shape. Comparing distal tip position or movement, or lack thereof, to commanded or actual proximal catheter or guidewire movement at the hub can be used to detect loss of relative motion, which can indicate device shaft buckling, prolapse, kinking, or similar consequences (e.g., along the device shaft length inside the body (e.g., in the aorta) or outside the body between the hubs). Processing can be done in real time to provide position / orientation data at up to 30 Hz, although this technique will only provide data while fluoroscopic imaging is turned on. In some embodiments, similar to driver assistance, machine vision algorithms can be used to generate and suggest optimal catheter maneuvers to access or reach anatomical landmarks. Machine vision algorithms can utilize the data to automatically navigate the catheter according to the anatomy presented by fluoroscopy.

[0136] The proximal torque applied to a catheter or guidewire shaft can be determined using a dual-encoder torque sensor. Referring to FIG. 14, a first encoder 144 and a second encoder 146 can be spaced axially along a shaft 148 to measure the difference in angle over the length of a flexible catheter / tube. The difference in angle is interpolated as torque because the catheter / tube has a known torsional stiffness. When torque is applied to the shaft, the slightly flexible portion of the shaft will twist. The difference between the angles measured by the encoders (dθ) gives the torque: T=k*dθ, where k is the torsional stiffness.

[0137] Ensuring the absence of bubbles in the fluid line can also be achieved using a bubble sensor, especially when the physician is remote from the patient. This can be achieved using a non-contact ultrasonic sensor that measures the intensity and Doppler shift of reflected ultrasound through the sidewall of the fluid tubing to detect bubbles and measure fluid flow rate or level. An ultrasonic or optical sensor can be positioned adjacent to the inflow fluid flow path in the hub or in the supply line leading to the hub. To detect the presence of air bubbles in an infusion line (which is formed from an ultrasonically or optically transparent material), the sensor can include a signal source on a first side of the flow path and a receiver on a second side of the flow path to measure transmission through the liquid passing through the tubing to detect bubbles. Alternatively, the reflected ultrasound signal can be detected from the same side of the flow path as the source due to the relatively high echogenicity of bubbles.

[0138] Preferably, the bubble removal system is automatically activated upon detection of an in-line bubble. The processor can be configured to activate a valve positioned in the flow path downstream of the bubble detector upon detection of a bubble. The valve diverts the column of fluid from the flow path to the patient into the reservoir. Once bubbles are no longer detected in the flow path, and after a volume of fluid in the flow path between the detector and the valve has passed through the valve, the valve can be activated to reconnect the source of fluid to the patient through the flow path. In other embodiments, the bubble removal system can include a pump and control system upstream of the bubble detector for removal of in-line bubbles. The processor can be configured to activate the pump upon detection of a bubble to reverse fluid flow and remove the bubble into the waste reservoir before reestablishing forward, bubble-free flow.

[0139] Additionally, it may be desirable for the physician to be able to view the aspirated clot at a predetermined location within the sterile field, and preferably as close to the patient as practical for fluid management purposes. This can be accomplished by providing a clot retrieval device mounted on the hub or mounted in the aspiration line leading away from the hub toward the pump. Referring to FIG. 15 , one example of a clot retrieval device 370 can include a body portion 380 enclosing a chamber 381 that communicates with a first port 310 and a second port 320.

[0140] In some embodiments, body 380 includes a housing having a top portion 382 and a bottom portion 384. Body 380 can include filter 330, which is positioned within chamber 381 between top portion 382 and bottom portion 384. In some examples, first port 310 is configured to connect to a first end of first tubing 340, which is fluidly connected to the proximal end of the suction catheter.

[0141] In embodiments configured to be connected downstream from a hub, first tube 340 includes connector 342 positioned at a second end of first tube 340 that is configured to engage or mate with a corresponding connector on or in communication with the hub. First port 310 is in direct communication with the chamber upstream (e.g., top side) of the filter, and second port 320 is in direct communication with the chamber downstream (e.g., bottom side) of the filter, facilitating direct visualization of captured material on the upstream side of the filter.

[0142] In implementations configured for remote operation, any of a variety of sensors may be provided to detect clots passing through the aspiration line and / or trapped in the filter, such as, for example, optical sensors, pressure sensors, flow sensors, ultrasonic sensors, or others known in the art.

[0143] In some embodiments, the second port 320 is configured to connect to a first end of a second tube 350 that is fluidly connected to a suction source (e.g., a pump). In some embodiments, the second tube 350 includes a connector 352 positioned at the second end of the second tube 350 that is configured to engage or mate with a corresponding connector on the pump.

[0144] In some examples, system 300 can include an on-off valve 360, such as clamp 360. Clamp 360 can be positioned between filter 330 and the patient (e.g., on first tube 340) to allow a user to engage the clamp and to provide flow control by isolating the patient from clot retrieval device 370. Closing valve 360 and operating a remote vacuum pump (not shown) causes the vacuum pump and the canister associated with chamber 381 to reach the same low pressure. Due to the short lumen distance and small line volume between chamber 381 and the distal end of the catheter, a sharp negative pressure spike is experienced at the distal end of the catheter quickly following the opening of valve 360. Additional details are disclosed in U.S. Patent No. 11,259,821, entitled "Aspiration System with Accelerated Response," issued March 1, 2022 to Buck et al., the entire contents of which are expressly incorporated herein by reference. In some embodiments, a vacuum can be circulated over the clot to retrieve it. The vacuum can be automatically and robotically controlled to remove the clot.

[0145] The body portion 380 can have a top surface spaced apart from a bottom surface by a tubular sidewall. In the illustrated implementation, the top and bottom surfaces are substantially circular and spaced apart by a cylindrical sidewall. The top surface can have a diameter at least about three or five or more times the axial length (transverse to the top and bottom surfaces) of the sidewall to create a generally disk-shaped housing. Preferably, at least a portion of the top wall is optically transparent to improve clot visualization once the clot is trapped within the clot retrieval device 370. Additional details can be found in U.S. Patent Application No. 63 / 256,743, the entire contents of which are incorporated herein by reference.

[0146] In some examples, the main body portion 380 can include a flush port (not shown) configured to allow injection of an optically transparent medium (e.g., air, saline, or other fluid) into the chamber 381 to clear the optical path between the window and the filter for improved clot visualization once the clot is trapped in the filter 330.

[0147] The foregoing represents certain specific implementations of drive tables and associated components and catheters. As those skilled in the art will recognize in light of the disclosure herein, a wide variety of different drive table configurations can be made to support and axially advance and retract two, three, four, or more drive magnet assemblies for robotically driving interventional devices, fluidic elements, and electrical umbilical elements for transmitting electrical signals and fluids to the catheter hub. Additional details can be found in U.S. Patent Application Serial No. 17 / 527,393, the entirety of which is incorporated herein by reference.

[0148] Although the foregoing describes robotically driven and manually driven interventional devices, the devices can be manually driven, robotically driven, or a combination of both manually and robotically driven interventional devices, as will be recognized by those skilled in the art in light of the disclosure herein.

[0149] 16A-16C illustrate an exemplary control mechanism 2200 for manipulating an interventional device driven by (or otherwise associated with) a respective hub. For example, each hub can be manipulated and / or otherwise moved using at least one controller located within the control mechanism 2200. Each controller can be adapted to move its own hub and associated interventional device during an interventional procedure.

[0150] 16A, the control mechanism 2200 includes a first control unit 2202, a second control unit 2204, a third control unit 2206, and a fourth control unit 2208. More or fewer controls may be provided depending on the intended interventional device configuration. Each control unit 2202-2208 is movably carried on a shaft 2210, which is coupled to a distal bracket 2212 and a proximal bracket 2214. The control units 2202-2208 may be advanced distally or retracted proximally on the shaft 2210, as indicated by arrow 2218 and arrow 2216. Additionally, each control unit 2202-2208 may also be rotated about the shaft 2210, as indicated by arrow 2220. Movement of each control can trigger a responsive movement in a corresponding carriage on the support table, which can drive movement of a corresponding hub, as discussed above.

[0151] The control mechanism 2200 can be positioned on or near a patient support table with a set of hubs and catheter / interventional devices. In some implementations, the control mechanism 2200 can be positioned remotely from the support table, such as behind a radiation shield in a telemedicine implementation, or in a different room or geographic location.

[0152] Each controller 2202-2208 can correspond to and drive the movement of a hub and / or a hub and interventional device combination. For example, controller 2202 can be configured to drive hub 30 (FIG. 3F) to move an interventional device, such as a 0.088-inch guide catheter, corresponding to hub 30. Similarly, controller 2204 can be configured to drive hub 28 (122) to move an interventional device, such as a 0.071-inch treatment catheter. Controller 2206 can be configured to drive hub 126 to move an interventional device, such as a steerable access catheter. Controller 2208 can be configured to drive hub 26 to move an interventional device, such as a guidewire, axially and rotationally.

[0153] 16B illustrates an example of manually manipulating the control 2202 on the control mechanism 2200. In operation, when the user 2230 moves the control 2202 axially and distally along the shaft 2210, as indicated by arrow 2232, the corresponding coupled hub and / or interventional device can responsively move in the same direction by the same or scaled amount. When the user 2230 rotates the control 2202 about the shaft 2210 and advances the control proximally, as indicated by arrow 2234, the corresponding coupled interventional device will responsively move rotationally and proximally by the same or scaled amount. When the user 2230 moves the control 2202 rotationally about the shaft 2210, as indicated by arrow 2236 or arrow 2238, the corresponding coupled hub will rotationally drive the corresponding interventional device in the same direction and / or by the same or scaled amount.

[0154] Other axes and degrees of freedom can be defined to enable the control unit 2202 to perform movements that can be translated into movements of the hub and / or interventional device. For example, the control mechanism can be provided with one or more deflection controls configured to initiate lateral deflection within a deflection zone on a corresponding interventional device.

[0155] Axial movement of the control can be configured to move the coupled hub on a 1:1 basis or on a non-1:1 scaled basis. For example, if the user 2230 advances the control 2022 distally along the shaft 2210 approximately 5 millimeters, the corresponding hub can move distally 5 millimeters in response.

[0156] If the user 2230 rotates the control 2022 by 5 degrees about its axis of rotation, the coupled hub will rotate the corresponding interventional device on a 1:1 basis or on a non-1:1 scaled basis. The scaled amount can be selected to reduce or increase the distance and amount of rotation that the hub and / or interventional device travels in accordance with the control movement.

[0157] In some implementations, the scaled amounts described herein can be determined using a scale factor. The scale factor can be applied to one or both of the translational and rotational movements. In some implementations, a first scale factor is selected for the translational movement, and a second scale factor, different from the first scale factor, is selected for the rotational movement. The axial scaling factor can drive proximal catheter movement at a faster rate than distal catheter movement for a given proximal or distal manipulation of the control.

[0158] The rotational scale factor can be 1:1, while the axial scale factor can move the hub a greater distance than the control travel, such that the hub travel to control travel ratio is at least about 2:1, or 5:1, or 10:1, or more, depending on the desired axial length of the control assembly.

[0159] The control mechanism 2200 can be configured to allow the clinician to adjust the scale factor for different parts of the procedure. For example, distal advancement of the treatment catheter and access catheter through the guide catheter and to the selected ostium can preferably be achieved in a "fast" mode, while more distal travel into the neurovasculature can preferably be achieved in a slower mode by actuation of the speed control.

[0160] In another implementation, one or more controls can be configured to incrementally drive the advancement or retraction rate of a corresponding hub and associated catheter. For example, the distal control 2202 can drive a guide catheter. Small distal movements of the control 2202 can advance the guide catheter distally at a slow rate, while advancing the control 2202 distally a greater distance increases the rate of distal travel of the guide catheter.

[0161] Controlling the speed of the corresponding hubs, either axially or both axially and rotationally, can enhance the overall speed of the procedure. For example, advancement of various devices from the femoral access point to the aortic arch can desirably be achieved at a faster rate than more distal navigation closer to the treatment site. Also, proximal retraction of various devices (guidewires, access catheters, and treatment catheters, among others) can desirably be achieved at a relatively higher rate than distal advancement.

[0162] FIG. 16C illustrates another example of manually manipulating controls on the control mechanism 2200 to move a hub and / or other interventional devices. In some implementations, two or more controls 2202-2208 can be moved in combination to trigger movement of one or more hubs and / or associated interventional devices. In the depicted example, the user 2230 moves the control unit 2204 and the control unit 2206 in combination (e.g., sequentially, simultaneously), such as to simultaneously move a 0.088 guide catheter and a 0.071 suction catheter as a unit. Exemplary movement of the control unit 2204 can include axial proximal movement in the direction indicated by arrow 2250. Sequentially or simultaneously, the user 2230 can move the control unit 2206 axially in either of the directions indicated by arrows 2254 and 2256 and simultaneously move the control unit 2206 rotationally in either of the directions indicated by arrows 2258 and 2260.

[0163] In some implementations, each control mechanism and / or additional controls (not shown) can be color-coded, shape-coded, tactilely coded, or otherwise coded to indicate to the user 2230 which color is configured to move which hub or interventional device. In some implementations, the color coding of the controls can also be applied to the hub and / or interventional device, allowing the user to visually match a particular hub / device with a particular control.

[0164] In some implementations, control operations other than translational and rotational movements can be performed using the controllers 2202-2208. For example, the controllers 2202-2208 can be configured to drive shape and / or stiffness changes of the corresponding interventional device. The controllers 2202-2208 can be switched between different operating modes. For example, the controllers 2202-2208 can be switched between movements driven by acceleration and velocity and movements reflecting actual linear displacement or rotation.

[0165] In some implementations, the control mechanism 2200 can be provided with a visual display or other indicator of the relative position of the controls, which can correspond to the relative position of the interventional device. Such a display can depict any or all movement directions, commands, movement percentages performed, and / or hub and / or catheter indicators to show which devices are controlled by a particular control. In some implementations, the display can depict the applied force or resistance encountered by the catheter, or other measurements being detected or observed by a particular hub or interventional component.

[0166] In some implementations, the control mechanism 2200 can include a haptic component to provide haptic feedback to a user operating the controller. For example, if the controller 2202 is triggering catheter movement and the catheter detects a large force at the tip, the controller 2202 can generate haptic feedback to indicate to the user to stop or reverse the movement that was performed. In some implementations, haptic feedback can be generated in the controller to indicate to the user to use the controller to slow or speed up the movement. In some implementations, haptics can provide feedback regarding the accumulation of large torsional strains that may precede a sharp rotation or the accumulation of large axial forces that may be a precursor to catheter buckling.

[0167] The systems described herein can compare actual fluoroscopic image positions with input displacements from a controller. A static fluoroscopic image of the patient can be captured, in which the patient's vasculature is indexed relative to bony landmarks or one or more implanted soft tissue fiducial markers. A real-time fluoroscopic image can then be displayed as an overlay, aligned with the static image by fiducial marker registration. Visual observation of the compatibility of real-time movement with the static image, aided by detected force data, can help confirm proper navigation of the associated catheter or guidewire. The systems described herein can also display a comparison of the input proximal mechanical translation of the catheter or guidewire and the resulting distal tip output motion, or lack thereof. Loss of relative motion at the distal tip can indicate shaft buckling, prolapse, kinking, or similar consequences, either inside or outside the body. Such a comparison can be beneficial when shaft buckling, prolapse, kinking, or similar consequences occur outside the current fluoroscopic field of view.

[0168] 17 illustrates a side schematic view of a multi-catheter interventional device assembly 2900 for combined supra-aortic and / or neurovascular site access and treatment (e.g., aspiration) as described herein. The multi-catheter assembly 2900 can be configured for either manual or robotic procedures.

[0169] Interventional device assembly 2900 includes an insertion or access catheter 2902, a treatment catheter 2904, and a guide catheter 2906. Other components are possible, including, but not limited to, one or more guidewires (e.g., optional guidewire 2907), one or more guide catheters, an access sheath, and / or one or more other treatment catheters, and / or associated catheter (control) hubs. In some embodiments, assembly 2900 can also be configured with an optional deflection control 2908 for controlling the deflection of one or more catheters of assembly 2900.

[0170] In operation, the multi-catheter assembly 2900 can be used without the need to exchange hub components. For example, in the previously disclosed two-stage procedure, the first stage to achieve supra-aortic access involves loading the access catheter, guide catheter, and guidewire onto a support table. Once supra-aortic access is obtained, the access catheter and guidewire are typically removed from the guide catheter. A second catheter assembly is then introduced through the guide catheter after attaching a new guidewire hub and procedure catheter hub to corresponding drive carriages on the support table.

[0171] The single multi-catheter assembly 2900 of FIG. 17 is configured to be operated without the need to remove hubs and catheters and without the addition of additional assemblies and / or hubs. Thus, the multi-component access and treatment configuration of assembly 2900 can utilize guidewire 2907, which is manufactured to function as both an access guidewire and a navigation guidewire, allowing for sufficient access and support to, and navigation of, a particular distal treatment site. In a non-limiting example configured for robotic implementation, the catheter assembly can include a guidewire hub (e.g., guidewire hub 2909 or guidewire hub 26 positioned on the drive table and to the right of catheter 2902), an insertion or access catheter hub 2910, a treatment catheter hub 2912, a guide catheter hub 2914, and corresponding catheters. In certain embodiments, one or more of the hubs can include or be coupled to a hemostasis valve (e.g., a rotary hemostasis valve) to accommodate the introduction of an interventional device therethrough. Additional details regarding hemostasis valves are contained in U.S. Patent Application No. 17 / 879,614, entitled "Multi Catheter System With Integrated Fluidics Management," filed August 2, 2022, which is expressly incorporated herein in its entirety.

[0172] Once access is achieved above the aortic arch, the insertion or access catheter 2902 (associated with the insertion catheter hub 2910) can be placed near the carotid ostium, and the remainder or subset of the catheter assembly can be guided more distally toward a particular site (e.g., clot site, surgical site, treatment site, etc.).

[0173] In some embodiments, additional smaller treatment catheters may be used at the site. As used herein with respect to catheter assembly 2900, in a robotic configuration of assembly 2900, catheter 2906 may function as a guide catheter. Catheter 2904 may function as a treatment (e.g., suction) catheter. In some embodiments, catheter 2906 may function to perform suction in addition to functioning as a guide catheter, instead of or in addition to catheter 2904. Access catheter 2902 may have a distal deflection zone and may function to access a desired ostium. Those skilled in the art will recognize from FIGS. 18A-18E that either manual or robotic manipulation of a multi-catheter stack is contemplated herein.

[0174] In some embodiments, catheter assembly 2900 (or other combined catheter assemblies described herein) can be driven to a predetermined location as a unit, but each catheter (or guidewire) component can instead be actuated and driven to the same or different locations independently of each other.

[0175] In a non-limiting example, catheter assembly 2900 can be used for a diagnostic angiography procedure. In some embodiments, assembly 2900 can include only guidewire 2907 and access catheter 2902 (in the form of a diagnostic angiography catheter) for performing a diagnostic angiography procedure, or only guidewire 2907 and access catheter 2902 can be utilized during the procedure. Alternatively, guide catheter 2906 and treatment catheter 2904 can be retracted proximally to expose the distal end of access catheter 2902 (e.g., several centimeters of the distal end of the access catheter) to perform a diagnostic angiography procedure.

[0176] 17, guide catheter 2906, treatment catheter 2904, access catheter 2902, and guidewire 2907 can be arranged concentrically. In certain embodiments, guide catheter 2906 can be a "large bore" guide or access catheter having a diameter of at least about 0.075 or at least about 0.080 inches. Treatment catheter 2904 can be an aspiration catheter having a diameter in the range of about 0.060 inches to about 0.075 inches. Access catheter 2902 can be a steerable catheter with a deflectable distal tip having a diameter in the range of about 0.025 inches to about 0.050 inches. Guidewire 2907 can have a diameter in the range of about 0.014 inches to about 0.020 inches. In one example, the guide catheter 2906 can have a diameter of approximately 0.088 inches, the treatment catheter 2904 can have a diameter of approximately 0.071 inches, the access catheter 2902 can have a diameter of approximately 0.035 inches, and the guidewire 2907 can have a diameter of approximately 0.018 inches.

[0177] 18A-18E depict an exemplary sequence of steps for introducing, either manually or robotically, a multi-catheter assembly configured to provide access to a blood clot. 18A-18E can be described using the interventional device assembly of FIG. 17. Other combinations of catheters can be substituted for the interventional device assembly, as one of ordinary skill in the art would recognize in light of the disclosure herein.

[0178] Referring to FIG. 18A, a three catheter interventional device assembly 2900 is shown being driven through an introducer sheath 3002, through an iliac artery 3004, and into the descending aorta. Next, the access catheter 2902, the treatment catheter 2904 (e.g., 0.071 inches), and the guide catheter 2906 (e.g., 0.088 inches) are tracked to the aortic arch 3006, as shown in FIG. 18B. Here, the distal end of the guide catheter 2906 can be placed below the aortic arch 3006, and the treatment catheter 2904, the access catheter 2902 (positioned within the treatment catheter 2904 and not visible in FIG. 18B), and the guidewire 2907 can be driven (e.g., simultaneously or separately) into the ostium. In some embodiments, the access catheter 2902 is advanced out of the treatment catheter 2904 and the guide catheter 2906, engaging the ostium first. After the distal end of the access catheter 2902 is positioned within the desired ostium, the guidewire 2907 can be advanced distally into the ostium to secure access. After the access catheter 2902 and guidewire 2907 are positioned within the desired ostium, the treatment catheter 2904 and / or guide catheter 2906 can be advanced into (and, in some embodiments, beyond) the ostium, using the support of the access catheter 2902 and / or guidewire 2907 to navigate through the aorta and into the ostium. In the embodiment shown in FIG. 18B , the treatment catheter 2904 has been advanced into the ostium, while the guide catheter 2906 remains indwelling below the aortic arch 3006.

[0179] 18C, the guidewire 2907 can be advanced distally, and the radiopacity of the guidewire 2907 can be used to confirm under fluoroscopic imaging that access through the desired ostium has been achieved. The guidewire 2907 engages the origin of the brachiocephalic trunk 3014. The guidewire 2907 is then advanced to the petrous segment 3018 of the internal carotid artery 3016.

[0180] 18D, guide catheter 2906 and treatment catheter 2904 (positioned within guide catheter 2906 and not visible in FIG. 18D) are both advanced (e.g., simultaneously or sequentially) over guidewire 2907 and over insertion or access catheter 2902 (positioned within treatment catheter 2904 and not visible in FIG. 18D), while access catheter 2902 remains at the ostium for support. Guidewire 2907 can be advanced further beyond cone segment 3018 to the site of clot 3020, such as the M1 segment.

[0181] 18E , guide catheter 2906 and treatment catheter 2904 (positioned within guide catheter 2906 and not visible in FIG. 18E ) are advanced (e.g., simultaneously or sequentially) to position the distal tip of treatment catheter 2904 at the treatment site (e.g., at the face of clot 3020). Guidewire 2907 and access catheter 2902 (positioned within treatment catheter 2904 and not visible in FIG. 18E ) are removed, and aspiration of clot 3020 begins through treatment catheter 2904. That is, guidewire 2907 and access catheter 2902 are retracted proximally to allow aspiration through treatment catheter 2904. After aspiration of the clot, treatment catheter 2904 and guide catheter 2906 can be removed (e.g., simultaneously or sequentially). For example, in some embodiments, treatment catheter 2904 can be removed before removing guide catheter 2906.

[0182] The catheter assembly 2900 can be used to perform a neurovascular procedure, as illustrated in FIGS. 18A-18E. For example, the neurovascular procedure can be a neurovascular thrombectomy. The steps of the procedure can include providing an assembly including at least a guidewire, an access catheter, a guide catheter, and a treatment catheter. For example, the catheter assembly 2900 includes a guidewire 2907, an access (e.g., insertion) catheter 2902, a guide catheter 2906, and at least one treatment catheter 2904. The treatment catheter 2904 can include an aspiration catheter, an embolism deployment catheter, a stent deployment catheter, a flow diverter deployment catheter, a diagnostic angiography catheter, a stent retriever catheter, a clot retrieval catheter, a balloon catheter, a catheter for facilitating percutaneous valve repair or replacement, an ablation catheter, and / or an RF ablation catheter or guidewire.

[0183] The neurovascular procedure may further include coupling the assemblies to a non-robotic or robotic drive system and driving the assemblies to achieve supra-aortic access. The steps may further include driving a subset of the assemblies to a neurovascular site and performing the neurovascular procedure using the subset of the assemblies. The subset of assemblies may include a guidewire, a guide catheter, and a treatment catheter.

[0184] Each of the guidewire 2907, access catheter 2902, guide catheter 2906, and treatment catheter 2904 is configured to be regulated by a respective hub. For example, the guidewire 2907 can include (or be coupled to) a hub mounted on one of the tray assemblies described herein. Similarly, the access catheter 2902 can be coupled to a catheter hub 2910. The guide catheter 2906 can be coupled to a guide catheter hub 2914. The treatment catheter 2904 can be coupled to a treatment catheter hub 2912.

[0185] Generally, coupling of the assemblies can include magnetically coupling a first hub 2909 on the guidewire 2907 to a first drive magnet, a second hub 2910 on the access catheter 2902 to a second drive magnet, a third hub 2912 on the treatment catheter 2904 to a third drive magnet, and a fourth hub 2914 on the guide catheter 2906 to a fourth drive magnet. Generally, the first, second, third, and fourth drive magnets are each independently movably carried by a drive table, as described with respect to the tray assemblies and controls described herein. In some embodiments, the first, second, third, and fourth drive magnets are coupled (e.g., to their respective catheter hubs) through a sterile barrier (e.g., a sterile barrier and a fluid barrier) and independently movably carried by a drive table having a plurality of driven magnets. In some embodiments, two or more drive magnets can be tethered or otherwise coupled together so that they move as a unit in response to commands from a single controller that is tethered or otherwise coupled to one of the drive magnets.

[0186] In some implementations, performing a neurovascular procedure can include driving the hub adapters in response to movement of each of the hub adapters along the support table until the assemblies are positioned to provide supra-aortic vascular access. The hub adapters can include, for example, a coupler / carriage that acts as a shuttle by advancing proximally or distally along a track in response to an operator command. The hub adapters described herein can each include at least one drive magnet configured to couple with a driven magnet carried by the respective hub. This provides a magnetic coupling between the drive magnet and the driven magnet through the sterile barrier such that the respective hubs are moved across the top of the sterile barrier in response to movement of the hub adapter outside the sterile field (as described in detail in FIG. 4 ). Movement of the hub adapters is driven by a drive system carried by the support table on which the guidewire hub 2909, guide catheter hub 2914, procedure catheter hub 2912, and access catheter hub 2910 are mounted.

[0187] The steps can further include actuating the subset of assemblies in response to respective movement of the hub adapters along the support table until the subset of assemblies is positioned to perform a neurovascular procedure at the neurovascular treatment site. The subset of assemblies can include a guidewire 2907, a guide catheter 2906, and a treatment catheter 2904.

[0188] In some embodiments, the guidewire 2907, guide catheter 2906, and treatment catheter 2904 are advanced as a unit through (with respect to the guidewire 2907) and over (with respect to the guide catheter 2906 and treatment catheter 2904) at least a portion of the length of the access (e.g., insertion) catheter 2902 after supra-aortic access has been achieved.

[0189] In some embodiments, the catheter assembly 2900 can be part of a robotic control system for achieving supra-aortic access and neurovascular treatment site access, as illustrated in FIGS. 18A-18E . In some embodiments, the catheter assembly 2900 can be part of a manually controlled system for achieving supra-aortic access and neurovascular treatment site access. In some embodiments, the catheter assembly 2900 can be part of a hybrid control system (comprising manual and robotic components) for achieving supra-aortic access and neurovascular treatment site access. For example, in such a hybrid system, the supra-aortic access can be robotically driven, while the neurovascular site access and embolectomy or other procedure can be manual. Alternatively, in such a hybrid system, the supra-aortic access can be manual, while the neurovascular site access can be robotically achieved. Furthermore, in such a hybrid system, any one or more of the guidewire, access catheter, guide catheter, or treatment catheter can be robotically driven or manually operated.

[0190] The exemplary robotic control system can include at least a guidewire hub (e.g., guidewire hub 2909) configured to adjust the axial and rotational positions of guidewire 2907. The robotic control system can also include an access catheter hub 2910 configured to adjust the axial and rotational movement of access catheter 2902. The robotic control system can also include a guide catheter hub 2914 configured to control the axial movement of guide catheter 2906. The robotic control system can also include a treatment catheter hub 2912 configured to adjust the axial and rotational position of treatment catheter 2904.

[0191] In some embodiments, the treatment catheter hub 2912 is further configured to laterally deflect a distal deflection zone of the treatment catheter 2904 .

[0192] In some embodiments, guidewire hub 2909 is configured to couple to the guidewire hub adapter by magnetically coupling the guidewire hub to a first drive magnet. Access catheter hub 2910 is configured to couple to the access catheter hub adapter by magnetically coupling the access catheter hub 2910 to a second drive magnet. Treatment catheter hub 2912 is configured to couple to the treatment catheter hub adapter by magnetically coupling the treatment catheter hub 2912 to a third drive magnet. Guide catheter hub 2914 is configured to couple to the guide catheter hub adapter by magnetically coupling the guide catheter hub 2914 to a fourth drive magnet. In some embodiments, the first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet are independently movably carried by a drive table.

[0193] In some embodiments, the robotic control system includes a first driven magnet on the guidewire hub 2909. The first driven magnet can be configured to cooperate with the first drive magnet such that the first driven magnet is configured to move in response to movement of the first drive magnet. In some embodiments, the first drive magnet is configured to move outside the sterile field separated from the first driven magnet by a barrier, while the first driven magnet is within the sterile field. In some embodiments, the position of the first driven magnet is movable in response to manipulation of a treatment drive control on a control console associated with the drive table. The interaction of the drive magnet and driven magnet is described in detail with respect to FIG. 4 above.

[0194] In some embodiments, the robotic control system includes a second driven magnet on the access catheter hub 2910. The second driven magnet can be configured to cooperate with the second drive magnet such that the second driven magnet is configured to move in response to movement of the second drive magnet. In some embodiments, the second drive magnet is configured to move outside the sterile field separated from the second driven magnet by a barrier, while the second driven magnet is within the sterile field.

[0195] In some embodiments, the robotic control system includes a third driven magnet on the treatment catheter hub 2912. The third driven magnet can be configured to cooperate with the third drive magnet such that the third driven magnet is configured to move in response to movement of the third drive magnet. In some embodiments, the third drive magnet is configured to move outside the sterile field separated from the third driven magnet by a barrier, while the third driven magnet is within the sterile field.

[0196] In some embodiments, the robotic control system includes a fourth driven magnet on the guide catheter hub 2914. The fourth driven magnet can be configured to cooperate with the fourth drive magnet such that the fourth driven magnet is configured to move in response to movement of the fourth drive magnet. In some embodiments, the fourth drive magnet is configured to move outside the sterile field separated from the fourth driven magnet by a barrier, while the fourth driven magnet is within the sterile field. In some embodiments, there can be more than four driven magnets and corresponding catheter hubs for control of additional catheters.

[0197] In some embodiments, the devices described herein (e.g., hubs, hub adapters, interventional devices, and / or trays) can be used during robotically driven procedures. For example, in a robotically driven procedure, one or more of the interventional devices can be driven through the vasculature to a treatment site. Robotically driving such devices can include engaging electromechanical components controlled by user input. In some implementations, a user can provide input at a control system that interfaces with one or more hubs and hub adapters.

[0198] In some embodiments, the hubs, hub adapters, interventional devices, and trays described herein can be used during non-robotic (e.g., manually driven) procedures. Manually driving such devices can include manually engaging the hub to affect movement of the interventional device.

[0199] In some embodiments, the devices described herein can be used to perform a method of performing an intracranial procedure at an intracranial site. The method of performing an intracranial procedure can include any of the same steps described herein for performing a neurovascular procedure. The procedure can be performed robotically, manually, or a hybrid combination of both.

[0200] While the foregoing describes magnetic coupling of the hub to the drive magnet, in other embodiments, either the interventional device and / or the hub can be mechanically coupled to the drive system. Any of the methods described herein can include mechanically coupling one or more interventional devices (e.g., guidewire 2907, access catheter 2902, treatment catheter 2904, and / or guide catheter 2906) and / or one or more hubs (e.g., guidewire hub 2909, access catheter hub 2910, treatment catheter hub 2912, and / or guide catheter hub 2914) to one or more drive mechanisms.

[0201] 19 illustrates a mechanical linkage 1654 between the drive mechanism 1650 and the driven mechanism 1652. The drive mechanism 1650 and the driven mechanism 1652 can have any of the same or similar features or functionality as the drive magnet 67 and the driven magnet 69, respectively, unless otherwise described herein. The drive mechanism 1650 can be part of or coupled to a hub adapter (e.g., hub adapter 48). The driven mechanism 1652 can be part of or coupled to a hub (e.g., hub 36, guidewire hub 2909, access catheter hub 2910, procedure catheter hub 2912, or guide catheter hub 2914). In some cases, the mechanical linkage 1654 can include structural support (e.g., a support rod or support strut) extending transversely through a seal in the sterile barrier 1632. The seal can allow the structural support to be advanced along the length of the sterile barrier 1632 while still maintaining a seal with the structural support to maintain a sterile field when the drive mechanism 1650 and driven mechanism 1652 are advanced and / or retracted, as described herein. For example, the seal can include a tongue and groove closure mechanism along the sterile barrier 1632 that is configured to close on either side of the structural support while allowing passage of the structural support through the sterile barrier 1632 and maintaining a seal against the structural support as the structural support is advanced along the length of the sterile barrier 1632.

[0202] In some embodiments, the structural support can extend through an elongated self-closing seal between two adjacent joining edges (e.g., similar in shape to duckbill valves) of flexible material extending along an axis. As the structural support advances along the axis between the joining edges, the joining edges can allow the structural support to advance and then be biased back into sealing engagement with one another as the structural support passes any given point along the axis.

[0203] In some embodiments, the drive mechanism can be a splined drive shaft (e.g., a non-sterile splined drive shaft). The mechanical linkage 1654 can include a pulley in the plate that serves as the sterile barrier 1632 and a sterile splined shaft configured to couple to the driven mechanism 1652. The driven mechanism 1652 can be a sterile pulley that receives the sterile splined shaft from the sterile barrier. In some embodiments, one or more splined drive shafts can engage and turn a corresponding pulley in the plate that serves as the sterile barrier. Each hub can have a sterile pulley configured to receive the sterile splined shaft from the sterile barrier plate. Rotation of the splined drive shaft can turn a pulley in the sterile barrier plate, which can turn a sterile pulley in the hub via the sterile splined shaft.

[0204] It will be understood by those skilled in the art that any of the embodiments as described herein may be modified to incorporate a mechanical linkage, for example, as shown in FIG. 19.

[0205] The interventional devices described herein can be provided individually, or at least some of the interventional devices can be provided in a pre-assembled (e.g., nested or stacked) configuration. For example, the interventional devices can be provided in the form of an interventional device assembly (e.g., interventional device assembly 2900) in a concentric nested or stacked configuration. If provided individually, each catheter (and, in some embodiments, each corresponding catheter hub) can be unpackaged and primed, e.g., by flushing the catheter (and, in some embodiments, each corresponding catheter hub) to remove air from its inner lumen and replacing the air with a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium). After priming, the interventional devices can be manually assembled into a stacked configuration, e.g., through an introducer sheath, so that they are ready for introduction into the body for a surgical procedure.

[0206] Assembling the devices into a stacked configuration can include inserting the interventional devices individually into one another in order of size. For example, the interventional device with the second largest diameter can be inserted into the lumen of the interventional device with the largest diameter. Then, the interventional device with the third largest diameter can be inserted into the interventional device with the second largest diameter, and so on.

[0207] 17 , assembly can be performed by first inserting the distal end of catheter 2904 through hub 2914 and into catheter 2906. Catheter 2904 can be advanced through catheter 2906 until the distal tip of catheter 2904 is flush with or extends beyond the distal tip of catheter 2906 and / or until catheter 2904 cannot be inserted further. The distal end of catheter 2902 can then be inserted through hub 2912 and into catheter 2904. Catheter 2902 can be advanced through catheter 2904 until the distal tip of catheter 2902 is flush with or extends beyond the distal tip of catheter 2904 and / or until catheter 2902 cannot be inserted further. The distal end of guidewire 2907 can then be inserted through hub 2910 and into catheter 2902. Guidewire 2907 can be advanced through catheter 2902 until the distal tip of guidewire 2907 is flush with or extends beyond the distal tip of catheter 2902 and / or until guidewire 2907 cannot be inserted any further.

[0208] Embodiments in which two or more interventional devices are packaged together as a single unit in an assembled (e.g., nested or stacked) configuration can provide efficient unpackaging and preparation before use, as well as efficient assembly within a robotic control system. The interventional devices can be pre-loaded onto their respective hubs before packaging. In certain embodiments, two, three, or more interventional devices can be packaged in a fully nested (i.e., fully axially inserted) or nearly fully nested configuration. In a fully nested configuration, each interventional device is inserted as far as possible into the adjacent distal hub and interventional device. Such a fully nested configuration can minimize the total length of the interventional device assembly and minimize the size of the packaging required to accommodate the interventional device assembly.

[0209] In some embodiments, the interventional device can also be sterilized while in the assembled configuration prior to packaging, for example, using ethylene oxide gas. In some embodiments, the interventional device can be packaged while in the assembled configuration prior to sterilization with ethylene oxide gas. For interventional devices in a nested or stacked configuration, ethylene oxide gas can be provided in the space between adjacent interventional devices (e.g., the annular lumen between the outer diameter of a first interventional device nested within a second interventional device and the inner diameter of the second interventional device) for sterilization. In some embodiments, the interventional device assembly can be packaged in a thermoformed tray and sealed with an HDPE (e.g., Tyvek®) lid. The interventional device assembly can be unpackaged by a user in a non-sterile field by removing (e.g., opening or peeling) the lid. A user in a sterile field can then remove the interventional device assembly and place it on a sterile work surface, for example, of a robot-driven table, as described herein.

[0210] Packaging the interventional devices in an assembled configuration and in a sterile state can reduce the time associated with unpackaging and assembling individual interventional devices and facilitate efficient connection to a robotic drive system. Each interventional device and hub combination can be further packaged with fluidic connections for connecting to a fluid and / or vacuum source. In some embodiments, each hub or a hemostasis valve connected to the hub can include the fluidic connections.

[0211] After the interventional device assembly is unpackaged (e.g., after the interventional device assembly is positioned on a robotically driven table), priming can be performed while the devices are concentrically nested or stacked. This is preferably accomplished within each fluid lumen, such as, for example, the annular lumen between catheter 2906 and catheter 2904, and between each additional concentric interventional device in the concentric stack. In certain embodiments, the fluid lumen can include the lumen between the distal hub and the proximal interventional device, such as, for example, the lumen between hub 2914 and catheter 2904. In certain embodiments, priming can be performed while the devices are still in sterile packaging.

[0212] The fluidics connections can be connected to a fluidics system for delivering saline and contrast medium to the catheters and for providing suction. In some embodiments, the fluidics connections can be routed outside the sterile field for connection to the fluidics system. Once connected, the fluidics system can perform a priming sequence to flush each catheter of the interventional device assembly with a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium). The priming sequence can also include flushing each corresponding catheter hub with the fluid. The fluid can be degassed or degassed by the fluidics system before priming. In some embodiments, a vacuum source of the fluidics system can be used to evacuate air from each catheter during fluid flushing. In certain embodiments, the tip of the catheter can be placed into a container of fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) during priming, such that the fluid (but not air) in the container is aspirated through the tip of the catheter when the vacuum source is applied. In other embodiments, the tip of the catheter can be blocked (e.g., using a plug) to prevent air from being drawn out of the tip of the catheter when the vacuum source is applied. In certain embodiments, the priming process can be automated so that the user can provide a single command and each catheter (and, in some embodiments, each corresponding catheter hub) can be primed sequentially (e.g., as described with respect to Figures 20A-20C) or simultaneously.

[0213] Additional details regarding the fluidics system are disclosed in U.S. Patent Application No. 17 / 879,614, entitled "Multi Catheter System With Integrated Fluidics Management," filed August 2, 2022, which is expressly incorporated herein in its entirety.

[0214] When there is a reduction in the lumen cross-sectional area for flow, for example, when a second interventional device (e.g., a catheter or guidewire) extends into the lumen of a first interventional device, the fluid resistance within the lumen may be greater. The amount of fluid resistance may be affected by the length of the cross-sectional constriction, for example, due to the depth of axial insertion of the second interventional device within the first interventional device. A second interventional device extending partially through the lumen of the first interventional device may provide a smaller length of cross-sectional constriction and thus result in lower fluid resistance within the lumen of the first catheter than if the second interventional device extended completely through the lumen of the first interventional device. Therefore, fluid resistance can be reduced at least in part by reducing the depth of axial insertion (i.e., axial overlap) of the second interventional device into the lumen through which fluid will be injected (e.g., the length of the second interventional device into its concentrically adjacent lumen).

[0215] In some embodiments, when a certain depth of insertion of a second interventional device within a first interventional device is exceeded (e.g., when the second interventional device is at or near its maximum insertion depth within the first interventional device), the size of the fluid channel between the devices (e.g., the annular lumen between the first and second interventional devices) may lead to a higher than desirable amount of fluid resistance during the priming procedure. In some embodiments, the depth of insertion of the second interventional device within the first interventional device can be reduced to reduce the pressure required to prime the catheter and to reduce internal interference.

[0216] In some embodiments, catheters in an interventional device assembly can be separated from other interventional devices for priming to reduce the pressure required to prime the catheter and to reduce internal interference. The catheter being primed can be separated from the interventional device in the catheter's lumen by retracting the interventional device proximally within the catheter's lumen. For example, the interventional device in the lumen of the priming catheter can be retracted as proximally as possible from the priming catheter while still maintaining a nested or stacked relationship (e.g., at least about 2 cm or 5 cm or more of axial overlap) to minimize the pressure required to prime the catheter and to minimize internal interference. In other words, a catheter can be separated from a more proximal interventional device for priming while the distal tip of the adjacent proximal interventional device is still positioned within the catheter's lumen. Maintaining at least some of the distal tips of the adjacent proximal interventional devices within the catheter's lumen can allow for easier reinsertion and advancement of the proximal interventional device after priming.

[0217] In some embodiments, the axial overlap can be between about 2 cm and about 20 cm, between about 2 cm and 10 cm, between about 2 cm and 5 cm, between about 5 cm and 20 cm, between about 5 cm and 10 cm, or any other suitable range. In some embodiments, the axial overlap can be at least about 2 cm, at least about 5 cm, at least about 10 cm, at least about 20 cm, 2 cm or less, 5 cm or less, 10 cm or less, 20 cm or less, about 2 cm, about 5 cm, about 10 cm, about 20 cm, or any other suitable amount.

[0218] In some embodiments, the robotic drive table can be programmed to retract the inner interventional device as proximally as possible from the catheter being primed while still maintaining the nested or stacked relationship. In other embodiments, the robotic drive table can be programmed to separate the inner device from the catheter being primed a sufficient distance to optimize the length of the unobstructed lumen and to result in an amount of fluid resistance below a threshold. After the catheter being primed is separated from the other interventional devices, the catheter can be primed by flushing it with a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium, etc.).

[0219] After a catheter is primed, it can be returned to its initial position, and the next catheter in the interventional device assembly can be separated from the other interventional devices in its lumen for priming. This sequence can be repeated for each catheter in the interventional device assembly. In other embodiments, after a catheter is primed, it can be advanced to a ready or actuated position to begin insertion into the patient. While the foregoing describes separating the catheter to be primed by retracting the inner interventional device, the outer catheter can also be separated from the inner interventional device by advancing the outer catheter axially distally relative to the inner interventional device. An example of a priming process is described with reference to FIGS. 20A-20C.

[0220] FIG. 20A depicts interventional device assembly 2900 assembled in an axially compressed configuration in a concentric stack. As shown in FIG. 20A , the interventional devices can be fully nested within one another. This can be the configuration following unpackaging and placement of device assembly 2900 on a robotic drive table. The priming sequence can begin, for example, as shown in FIG. 20B , by axially advancing catheter 2906 and hub 2914 distally relative to catheter 2904, hub 2912, catheter 2902, hub 2910, guidewire 2907, and hub 2909 as far as possible while maintaining the distal tip of catheter 2904 within the lumen of catheter 2906, or to a distance that will result in a desired amount of fluid resistance for priming. In some embodiments, catheter 2906 is advanced in response to a control signal from a control system. Catheter 2906 can then be primed by introducing a priming fluid using the fluidics system. In some embodiments, the priming fluid is introduced in response to a control signal from a control system. Priming the catheter 2906 can include priming the hub 2914. For example, in certain embodiments, the hub 2914 or a hemostasis valve coupled thereto can include a fluidic connection for receiving the priming fluid from the fluidics system. After priming, the catheter 2906 can be returned to its initial position (e.g., a fully axially compressed configuration), as shown in FIG. 20A . In some embodiments, the catheter 2906 is returned to its initial position in response to a control signal from the control system.

[0221] After catheter 2906 has been primed and returned to its initial position, catheter 2904 and hub 2912 can be axially advanced distally relative to catheter 2902, hub 2910, guidewire 2907, and hub 2909 (and catheter 2906 and hub 2914 can be axially advanced distally without or only minimally changing their relative position with respect to catheter 2904), for example, as shown in FIG. 20C . In some embodiments, catheter 2904 and catheter 2906 are advanced in response to control signals from a control system. Catheter 2904 can then be primed by introducing a priming fluid using the fluidics system. In some embodiments, the priming fluid is introduced in response to a control signal from the control system. Priming catheter 2904 can include priming hub 2912. For example, in certain embodiments, hub 2912 or a hemostasis valve coupled thereto can include a fluidic connection for receiving priming fluid from a fluidics system. After priming, catheter 2904 and catheter 2906 can be returned to their initial position (e.g., a fully axially compressed configuration), as shown in FIG. 20A. In some embodiments, catheter 2904 and catheter 2906 are returned to their initial position in response to a control signal from a control system.

[0222] After catheter 2904 has been primed and returned to its initial position, catheter 2902 and hub 2910 can be advanced axially distally relative to guidewire 2907 and hub 2909 (and catheter 2906, hub 2914, catheter 2904, and hub 2912 can be advanced axially distally without or minimally changing their relative positions relative to catheter 2902), for example, as far as possible while maintaining the distal tip of guidewire 2907 within the lumen of catheter 2902, or to a distance that will result in a desired amount of fluid resistance for priming. In some embodiments, catheter 2902, catheter 2904, and catheter 2906 are advanced in response to control signals from a control system. Catheter 2902 can then be primed by introducing a priming fluid using the fluidics system. In some embodiments, the priming fluid is introduced in response to a control signal from the control system. Priming catheter 2902 can include priming hub 2910. For example, in certain embodiments, hub 2910 or a hemostasis valve coupled thereto can include a fluidic connection for receiving priming fluid from a fluidics system. After priming, catheter 2902 and catheters 2904 and 2906 can be returned to their initial positions (e.g., fully axially compressed configurations) shown in FIG. 20A. In some embodiments, catheter 2902, catheter 2904, and catheter 2906 are returned to their initial positions in response to control signals from a control system.

[0223] 20A-20C can be performed in response to a single control signal from a control system. In other embodiments, various steps of the priming procedure can be performed in response to unique control signals. In some embodiments, the priming of each unique interventional device can be performed in response to a unique control signal.

[0224] In an alternative embodiment, each of the catheters can be distally separated from one another simultaneously for priming. For example, catheter 2902 can be distally separated from guidewire 2907 while maintaining the distal tip of guidewire 2907 within the lumen of catheter 2902, catheter 2904 can be distally separated from catheter 2902 while maintaining the distal tip of catheter 2902 within the lumen of catheter 2904, and catheter 2906 can simultaneously be distally separated from catheter 2904 while maintaining the distal tip of catheter 2904 within the lumen of catheter 2906. However, as described with respect to FIGS. 20A-20C , embodiments in which only one set of adjacent hubs is separated at a time can provide a smaller overall length of the assembly at any particular time, which can enable use with smaller robotic drive systems. Although the separation of the outer catheter from the inner interventional device is described as advancing the catheter axially distally relative to the inner interventional device, the separation can include retracting the inner interventional device proximally from the outer catheter.

[0225] In alternative embodiments, one or more of catheter 2902, catheter 2904, and catheter 2906 can be advanced to a ready or driven position to begin insertion into a patient after priming (e.g., before priming a subsequent catheter). In such embodiments, the catheters can be advanced to the ready or driven position after priming without returning to their initial positions.

[0226] As explained above, in some embodiments, catheters 2902, 2904, and 2906 can be assembled into the concentric stack orientation shown in FIG. 17 before flushing the catheters to remove air by replacing it with a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium). This is preferably accomplished within each fluid lumen, such as the annular lumen between catheter 2906 and catheter 2904, and between each additional concentric interventional device in the concentric stack. Infusing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure can displace substantially all of the air, although some small bubbles may remain and may adhere to the inner wall of the outer catheter (e.g., guide catheter 2906), the outer wall of the inner catheter (e.g., treatment catheter 2904), or both.

[0227] While fluid is introduced under pressure into the proximal end of the annular lumen (e.g., into the hub of the outer catheter or a hemostatic valve connected thereto), the inner catheter can be moved relative to the outer catheter, breaking the holding forces between the microbubbles and the adjacent wall and allowing the bubbles to be carried downstream and exit through the distal opening of the lumen or removed via suction. The catheters can be moved axially, rotationally, or both relative to each other. In certain embodiments, the catheters can be reciprocated axially, rotationally, or both relative to each other. In some embodiments, the catheters can be moved axially, rotationally, or both intermittently. In other embodiments, the catheters can be rotated continuously or in a constant direction.

[0228] In some implementations, the first catheter is reciprocated axially relative to an adjacent catheter or guidewire over a stroke length in the range of, for example, about 1 mm to about 250 mm, about 10 mm to about 250 mm, about 5 mm to about 125 mm, about 25 mm to about 125 mm, about 10 mm to about 50 mm, about 15 mm to about 30 mm, about 5 mm to about 30 mm, about 15 mm to about 25 mm, about 20 mm to about 40 mm, or any other suitable range. In some implementations, the first catheter is reciprocated axially relative to an adjacent catheter or guidewire over a stroke length of, for example, at least 5 mm, at least 10 mm, at least 15 mm, at least 20 mm, at least 25 mm, at least 30 mm, at least 50 mm, 10 mm or less, 20 mm or less, 25 mm or less, 30 mm or less, 50 mm or less, 125 mm or less, 150 mm or less, about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 50 mm, or any other suitable stroke length.

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

[0230] In one implementation, the first catheter is reciprocated axially relative to an adjacent catheter or guidewire, for example, at a reciprocating frequency of about 5 cycles per second or less, or 2 cycles per second or less, over a stroke length in the range of about 0.5 inches to about 10 inches, or about 1 inch to about 5 inches.

[0231] In some implementations, the first catheter may be oriented at an angle, e.g., in the range of about 5 degrees to about 180 degrees, about 5 degrees to about 360 degrees, about 15 degrees to about 180 degrees, about 15 degrees to about 150 degrees, about 15 degrees to about 120 degrees, about 15 degrees to about 90 degrees, about 15 degrees to about 60 degrees, about 15 degrees to about 30 degrees, about 30 degrees to about 180 degrees, about 30 degrees to about 150 degrees, about 30 degrees to about 120 degrees, about 30 degrees to about 90 degrees, about 30 degrees to about 60 degrees, about 60 degrees to about to about 180 degrees, about 60 degrees to about 150 degrees, about 60 degrees to about 120 degrees, about 60 degrees to about 90 degrees, about 90 degrees to about 180 degrees, about 90 degrees to about 150 degrees, about 90 degrees to about 120 degrees, about 120 degrees to about 180 degrees, about 120 degrees to about 150 degrees, about 150 degrees to about 180 degrees, or any other suitable range of rotational angles per stroke. In some implementations, the first catheter is rotationally reciprocated relative to an adjacent catheter or guidewire through a rotational angle per stroke of, for example, at least 5 degrees, at least 15 degrees, at least 30 degrees, at least 60 degrees, at least 90 degrees, at least 120 degrees, at least 150 degrees, at least 180 degrees, at least 360 degrees, 5 degrees or less, 15 degrees or less, 30 degrees or less, 60 degrees or less, 90 degrees or less, 120 degrees or less, 150 degrees or less, 180 degrees or less, 360 degrees or less, about 5 degrees, about 15 degrees, about 30 degrees, about 60 degrees, about 90 degrees, about 120 degrees, about 150 degrees, about 180 degrees, about 360 degrees, or any other suitable angle.

[0232] In some implementations, the first catheter is reciprocated rotationally relative to an adjacent catheter or guidewire at a reciprocating frequency in the range of about 0.5 Hz to about 1 Hz, about 1 Hz to about 5 Hz, about 1 Hz to about 10 Hz, about 1 Hz to about 25 Hz, about 5 Hz to about 10 Hz, about 10 Hz to about 25 Hz, or any other suitable range of frequencies, etc. In some implementations, the first catheter is reciprocated rotationally relative to an adjacent catheter or guidewire at a reciprocating frequency of at least 0.5 Hz, at least 1 Hz, at least 2 Hz, at least 5 Hz, at least 10 Hz, at least 25 Hz, 0.5 Hz or less, 1 Hz or less, 2 Hz or less, 5 Hz or less, 10 Hz or less, 25 Hz or less, about 0.5 Hz, about 1 Hz, about 2 Hz, about 5 Hz, about 10 Hz, about 25 Hz, or any other suitable frequency, etc.

[0233] In some embodiments, the first catheter is reciprocated relative to an adjacent catheter or guidewire through between 1 and 200, between 1 and 100, between 1 and 50, between 1 and 25, between 1 and 15, between 1 and 10, between 1 and 5, between 5 and 25, between 5 and 15, between 5 and 10, or any other suitable range of reciprocations. In some embodiments, the first catheter is reciprocated relative to an adjacent catheter or guidewire through at least 1 reciprocation, at least 2 reciprocations, at least 5 reciprocations, at least 10 reciprocations, at least 15 reciprocations, at least 25 reciprocations, at least 50 reciprocations, 5 reciprocations or less, 10 reciprocations or less, 15 reciprocations or less, 25 reciprocations or less, 50 reciprocations or less, 100 reciprocations or less, 200 reciprocations or less, about 1 reciprocation, about 2 reciprocations, about 5 reciprocations, about 100 reciprocations, about 200 reciprocations, or any other suitable number. One reciprocating motion can include movement (axially or rotationally) from a first position to a second position, followed by movement from the second position back to the first position.

[0234] In some implementations, the first catheter is reciprocated relative to the adjacent catheter or guidewire for a length of time in the range of about 1 second to about 60 seconds, about 1 second to about 45 seconds, about 1 second to about 30 seconds, about 1 second to about 20 seconds, about 1 second to about 15 seconds, about 1 second to about 10 seconds, about 5 seconds to about 45 seconds, about 5 seconds to about 30 seconds, about 5 seconds to about 20 seconds, about 5 seconds to about 15 seconds, about 5 seconds to about 10 seconds, about 10 seconds to about 30 seconds, about 10 seconds to about 20 seconds, or any other suitable range. In some implementations, the first catheter is reciprocated relative to the adjacent catheter or guidewire for a length of time of at least 1 second, at least 5 seconds, at least 10 seconds, at least 15 seconds, at least 20 seconds, at least 30 seconds, at least 45 seconds, at least 60 seconds, 5 seconds or less, 10 seconds or less, 15 seconds or less, 20 seconds or less, 30 seconds or less, 45 seconds or less, 60 seconds or less, about 5 seconds, about 10 seconds, about 15 seconds, about 20 seconds, about 30 seconds, about 45 seconds, about 60 seconds, or any other suitable length of time.

[0235] Reciprocating movement of adjacent catheters to destroy microbubbles can be accomplished manually by grasping the corresponding catheter hubs and manually moving the catheters axially or rotationally relative to one another while delivering pressurized fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium). Alternatively, such as in a robotically driven system, the processor can be configured to robotically drive at least one of two adjacent catheter hubs (e.g., at least one of hubs 2914 and 2912) to effect relative movement between the adjacent catheters, thereby destroying and expelling microbubbles, such as in response to user activation of a flush control. For example, in certain embodiments, two adjacent interventional devices can be moved relative to one another in response to control signals from a control system. In certain embodiments, delivery of pressurized fluid can be performed in response to control signals from the control system.

[0236] The reciprocating motion of adjacent catheters can generate shear forces that dislodge air bubbles. For example, relative movement of the inner and outer surfaces of adjacent catheters can increase the fluid shear rate between adjacent catheters during priming compared to static surfaces. In some embodiments, the shear forces can be increased by increasing the flow rate of the solution (e.g., saline, contrast medium, or a mixture of saline and contrast medium) being provided by the fluidics system. In certain embodiments, both the flow rate and the relative movement between adjacent catheters are controlled to dislodge air bubbles.

[0237] In some embodiments, after each catheter is primed by the fluidics system, an ultrasonic bubble detector can be used to verify that the catheter is substantially free of air bubbles. For example, an ultrasonic tip (e.g., mounted in a hub adjacent to the catheter receiving lumen) can be run along the length of the catheter to verify that no air bubbles remain in the system.

[0238] An example of a priming process involving reciprocating adjacent catheters is described with respect to Figures 21A-21B.

[0239] 21A depicts an interventional device assembly 2900 assembled in a concentric stack configuration. As shown in FIG. 21A, the interventional devices can be fully nested within one another. This can be the configuration following unpackaging and placement of the device assembly 2900 on a robotic drive table. Alternatively, the individual interventional devices of the device assembly 2900 can be assembled into the device assembly 2900 on the drive table.

[0240] The priming sequence can begin by priming catheter 2906. In some embodiments, catheter 2906 can be primed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2906 while causing reciprocating movement of catheter 2906 and / or hub 2914 axially, rotationally, or both relative to catheter 2906. Priming catheter 2906 can include priming hub 2914. For example, in certain embodiments, hub 2914 or a hemostasis valve coupled thereto can include a fluidic connection for receiving priming fluid from a fluidics system. In certain embodiments, catheter 2906 and / or hub 2914 can be axially agitated back and forth along the longitudinal axis of catheter 2906 (e.g., between the positions of FIGS. 21A and 21B ). The axial and / or rotational reciprocating movement of catheter 2906 and / or hub 2914 can be performed manually or by a robotic drive table. The reciprocating movement can occur in response to control signals from a control system. The introduction of fluid under pressure can be performed in response to control signals from the control system.

[0241] In some embodiments, priming of catheter 2906 can be performed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2906 while causing reciprocating movement of catheter 2904 and / or hub 2912 axially, rotationally, or both relative to catheter 2906. The axial and / or rotational reciprocating movement of catheter 2904 and / or hub 2912 can be performed manually or by a robotically driven table. The reciprocating movement can be caused in response to a control signal from a control system. The introducing of fluid under pressure can be performed in response to a control signal from a control system.

[0242] In some embodiments, priming of catheter 2906 can be performed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2906 while causing reciprocating movement of both catheter 2906 (and / or hub 2914) and catheter 2904 (and / or hub 2912) axially, rotationally, or both relative to one another. The reciprocating movement can be caused in response to a control signal from a control system. The introducing of the fluid under pressure can be performed in response to a control signal from a control system.

[0243] In some embodiments, after priming the catheter 2906, the catheter 2906 can be returned to an initial position, as shown in Figure 21 A. In other embodiments, after priming the catheter 2906, the catheter 2906 can be advanced to a ready or actuated position to begin insertion into the patient.

[0244] In some embodiments, catheter 2904 can be primed after catheter 2906 is primed. Priming catheter 2904 can include priming hub 2912. For example, in certain embodiments, hub 2912 or a hemostasis valve coupled thereto can include a fluidic connection for receiving a priming fluid from a fluidics system. In some embodiments, catheter 2904 can be primed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2904 while causing reciprocating movement of catheter 2904 and / or hub 2912 axially, rotationally, or both relative to catheter 2906. The reciprocating movement can be caused in response to a control signal from a control system. Introducing the fluid under pressure can be performed in response to a control signal from a control system.

[0245] In some embodiments, priming of catheter 2904 can be performed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2904 while causing reciprocating movement of catheter 2902 and / or hub 2910 axially, rotationally, or both relative to catheter 2904. The axial and / or rotational reciprocating movement of catheter 2902 and / or hub 2910 can be performed manually or by a robotically driven table. The reciprocating movement can be caused in response to a control signal from a control system. The introducing of the fluid under pressure can be performed in response to a control signal from a control system.

[0246] In some embodiments, priming of catheter 2904 can be performed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2904 while causing reciprocating movement of both catheter 2904 (and / or hub 2912) and catheter 2902 (and / or hub 2910) axially, rotationally, or both relative to one another. The reciprocating movement can be caused in response to a control signal from a control system. The introducing of the fluid under pressure can be performed in response to a control signal from a control system.

[0247] In some embodiments, after priming the catheter 2904, the catheter 2904 can be returned to an initial position, as shown in Figure 21 A. In some embodiments, after priming the catheter 2904, the catheter 2904 can be advanced to a ready or actuated position to begin insertion into the patient.

[0248] In some embodiments, catheter 2902 can be primed after catheter 2904 is primed. Priming catheter 2902 can include priming hub 2910. For example, in certain embodiments, hub 2910 or a hemostasis valve coupled thereto can include a fluidic connection for receiving priming fluid from a fluidics system. In some embodiments, catheter 2902 can be primed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2902 while causing reciprocating movement of catheter 2902 and / or hub 2910 axially, rotationally, or both relative to guidewire 2907. The reciprocating movement can be caused in response to a control signal from a control system. Introducing the fluid under pressure can be performed in response to a control signal from the control system.

[0249] In some embodiments, priming of catheter 2902 can be performed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2902 while causing reciprocating movement of guidewire 2907 and / or hub 2909 axially, rotationally, or both relative to catheter 2902. The axial and / or rotational reciprocating movement of guidewire 2907 and / or hub 2909 can be performed manually or by a robotically driven table. The reciprocating movement can be caused in response to a control signal from a control system. The introducing of the fluid under pressure can be performed in response to a control signal from the control system.

[0250] In some embodiments, priming of catheter 2902 can be performed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2902 while causing reciprocating movement of both catheter 2902 (and / or hub 2910) and guidewire 2907 (and / or hub 2909) axially, rotationally, or both relative to one another. The reciprocating movement can be caused in response to a control signal from a control system. The introducing of the fluid under pressure can be performed in response to a control signal from the control system.

[0251] In some embodiments, after priming the catheter 2902, the catheter 2902 can be returned to an initial position, as shown in Figure 21 A. In other embodiments, after priming the catheter 2902, the catheter 2902 can be advanced to a ready or actuated position to begin insertion into the patient.

[0252] 21A and 21B can be performed in response to a single control signal from a control system. In other embodiments, various steps of the priming procedure can be performed in response to unique control signals. In some embodiments, the priming of each unique interventional device can be performed in response to a unique control signal.

[0253] 21A and 21B, the catheters are primed in order, starting with catheter 2906, followed by catheter 2904, and then catheter 2902. However, it is contemplated that the catheters may be primed in any order. The catheters may be primed serially as described above with respect to FIGS. 21A and 21B. Alternatively, two or more of the catheters, or each of the catheters, may be primed in parallel.

[0254] In certain embodiments, priming the catheter can include reducing the depth of axial insertion (i.e., axial overlap) of a second interventional device into the lumen of a first interventional device through which fluid is to be injected (e.g., the length of the second interventional device into its concentrically adjacent lumen), as described with respect to Figures 20A-20C, and also generating relative reciprocating movement between the first interventional device and the second interventional device, axially, rotationally, or both, during priming, as discussed with respect to Figures 21A and 21B.

[0255] In some implementations, priming a catheter can include vibrating at least a portion of the catheter and / or its associated hub, if included. The vibration can be induced, for example, by an electric motor built into the catheter hub or by a separate electric motor or vibration source placed against the catheter during priming. In some implementations, at least a portion of the support table on which the catheter and / or its associated hub rests can be vibrated during priming of any one or more catheters to aid in the removal of air and / or air microbubbles. Such vibration can be performed by an electric motor.

[0256] (Example) Additional embodiments are disclosed in more detail in the following examples, which are not intended to limit the scope of the claims in any way.

[0257] FIG. 22 is a diagram of a test system used to detect air bubble removal between concentrically stacked catheters. The test system included an inner catheter 2108 positioned within the internal lumen of an outer catheter 2106 in a concentric stack. The outer catheter 2106 was connected to a rotary hemostatic valve 2104. The hemostatic valve 2104 was connected to a syringe 2102 such that fluid injected using the syringe would flow through the lumen between the inner catheter 2108 and the outer catheter 2106. In the test system, the inner catheter 2108 had a diameter of approximately 0.071 inches. The outer catheter 2106 had a diameter of approximately 0.088 inches. The outer catheter 2106 was clear to allow visualization of bubbles within the lumen. The distal end of the outer catheter 2108 allowed a small volume of fluid to exit the outer catheter. Figure 23A is a photograph showing catheter 2106 and catheter 2108 in a concentric stack prior to fluid injection, and Figure 23D is an illustration of this.

[0258] Example 1 In a first example, syringe 2102 was used to inject water at a constant pressure of approximately 150 psi through hemostasis valve 2104 without moving catheter 2106 or catheter 2108. Figure 23B is a photograph showing catheter 2106 and catheter 2108 following the injection of water. Figure 23E is a diagrammatic representation. As shown in Figure 23B, a bubble is present in the lumen between catheter 2106 and catheter 2108.

[0259] Example 2 In a second example, the syringe 2102 was used to inject water through the hemostasis valve 2104 at a constant pressure of about 150 psi. Immediately after initiating the water injection, a reciprocating axial movement of the inner catheter 2108 was performed for about 10 seconds. The reciprocating movement was performed at a frequency of about 1 Hz (or less) and a stroke length of about 20 mm (or more). FIG. 23C is a photograph showing the catheter 2106 and catheter 2108 following the reciprocating axial movement. FIG. 23F is an illustration thereof. As shown in FIG. 23C, the lumen between the catheter 2106 and catheter 2108 was substantially free of bubbles.

[0260] Example 3 In the third example, instead of the outer catheter 2106 and inner catheter 2108 described with respect to Examples 1 and 2, an outer catheter having a diameter of approximately 0.071 inches and an inner catheter having a diameter of approximately 0.035 inches were used in the test system 2100. A syringe 2102 was used to inject water at a constant pressure of approximately 150 psi through a hemostasis valve 2104 connected to the outer catheter. Immediately after initiating the water injection, axial reciprocating motion of the inner catheter was performed for approximately 10 seconds. The reciprocating motion was performed at a frequency of approximately 1 Hz (or less) and a stroke length of approximately 20 mm (or more). Following the axial reciprocating motion, the lumen between the outer and inner catheters was found to be substantially free of bubbles by visual inspection.

[0261] Control System 24 illustrates a schematic diagram of an example control system 4000 that may be used to electronically control the systems and components described herein and / or to implement the methods described herein. The control system 4000 can be configured to automatically adjust various motors, hub adapters, hubs, interventional devices, fluidics components (e.g., valves, pumps, etc.), and / or any other components described herein in response to commands entered by an operator, such as a physician. In response to commands entered by the operator, the control system 4000 can automatically initiate a series of responsive events.

[0262] In certain embodiments, the control system 4000 can include one or more processors 4002. The one or more processors 4002 can be configured to automatically adjust various system components described herein in response to commands entered by an operator, for example, using one or more controllers 4004 of the control system 4000. A single controller 4004 is shown in FIG. 24 . However, any suitable number of controllers can be provided to correspond to various functions of the systems described herein. For example, in certain embodiments, each interventional device can have its own unique controller 4004 or set of controllers 4004 that can control various functions of the interventional device (e.g., axial movement, rotational movement, delivery of fluids (e.g., saline, contrast, etc.), aspiration, etc.).

[0263] In certain embodiments, the one or more controllers 4004 can control a priming function for one or more interventional devices. For example, the one or more controllers 4004 can be operated to cause an interventional device to perform a priming procedure, e.g., as described with reference to Figures 20A-20C. For example, the one or more controllers 4004 can be operated to cause axial movement of one or more interventional devices relative to one or more other interventional devices (e.g., by causing axial movement of corresponding hubs and / or hub adapters). The one or more controllers 4004 can be operated to cause introduction of a fluid into a lumen of an interventional device to prime the interventional device.

[0264] In certain embodiments, the one or more controllers 4004 can be operated to cause an interventional device to perform a priming procedure, e.g., as described with reference to Figures 21A-21B. For example, the one or more controllers 4004 can be operated to cause reciprocating movement (e.g., axial and / or rotational reciprocating movement) of one or more interventional devices relative to one or more other interventional devices (e.g., by causing reciprocating movement of corresponding hubs and / or hub adapters). The one or more controllers 4004 can be operated to cause introduction of a fluid into a lumen of an interventional device to prime the interventional device (e.g., during the relative reciprocating movement).

[0265] The processor 4002 can receive signals from one or more controllers 4004 and, in response, initiate corresponding actions in components of the systems described herein. For example, the processor 4002 can be configured to generate output signals that cause responsive actions to be performed by components of the systems described herein.

[0266] Although the foregoing describes robotically driven and manually driven interventional devices, the devices can be manually driven, robotically driven, or any combination of manually and robotically driven interventional devices, as will be recognized by those of ordinary skill in the art in light of the disclosure herein.

[0267] The foregoing represents one specific implementation of a robotic control system. As one of ordinary skill in the art will recognize in light of the disclosure herein, a wide variety of different robotic control system configurations can be created for robotically driving interventional devices, for supporting two, three, four, or more assemblies, and for axial advancement and retraction.

[0268] Although the foregoing describes an interventional device driven by a drive table, other suitable robotic drive systems or mechanisms can be used to drive the interventional device, as will be recognized by those skilled in the art in light of the disclosure herein.

[0269] Although the various systems and methods are described herein primarily in the context of neurovascular access or procedures (e.g., neurothrombectomy), the catheters, systems (e.g., drive systems), and methods disclosed herein can be readily adapted for any of a wide variety of other diagnostic and therapeutic applications throughout the body, including, for example, intravascular procedures in the peripheral vasculature (e.g., deep vein thrombosis), central vasculature (pulmonary embolism), and coronary vasculature, among others, as well as procedures in other hollow organs or tubular structures within the body. [Explanation of symbols]

[0270] 10 Interventional setup, 12 Patient support table, 14 Patient, 16 Imaging system, 18 Robotic interventional device drive system, 20 Support table, 22 Interventional device, 23 Display, 24 Femoral artery access point, 26 Guidewire hub, 27 Guidewire, 28 Access catheter hub, 29 Access catheter, 30 Guide catheter hub, 31 Guide catheter, 32 Sterile barrier, 34 Anti-buckling feature, 36 Hub, 38 Housing, 40 Proximal end, 42 Distal end, 48 Hub adapter, 51 Frame, 52 Proximal end, 53 First roller, 54 Distal end, 55 Second roller, 56 Support table support, 58 First drive pulley, 59 First hub adapter roller, 60 First drive belt, 61 First carriage bracket, 62 Drive pulley teeth, 63 Second hub adapter roller, 64 Second drive pulley, 66 Second drive belt, 67; drive magnet, 68; second carriage bracket, 69; driven magnet, 70; third drive pulley, 72; third drive belt, 73; third carriage bracket, 74; drive support, 75; motor, 76; rotatable shaft, 78; first bearing, 79; second bearing, 80; shaft coupling, 82; motor bracket, 84; first idler pulley, 86; second idler pulley, 88; third idler pulley, 90; tensioning bracket, 92; tensioning adjustment, 94; rotatable shaft, 96; first bearing, 98; second bearing, 100; proximal end, 102; distal end, 104; support surface, 106; first channel, 108; floor, 110; outer sidewall, 111; inner sidewall, 112; second channel, 120; first treatment catheter, 122 Hub, 124 Second treatment catheter, 126 Hub, 140 First conductor, 142 Second conductor, 144 First encoder, 146 Second encoder, 148 Shaft, 204 Upper support surface, 205 Channel, 206 Channel, 207 Channel, 212 Channel, 228 Frame support boss, 232 Sterile barrier, 233 Upper surface, 236 Structural rib, 238 Frame support boss, 240 Trough, 242 Drain hole, 250 Hub, 300 System, 310 First port, 320 Second port, 330Filter, 340 First tubing, 342 Connector, 350 Second tubing, 352 Connector, 360 Clamp, valve, 370 Clot retrieval device, 380 Body, 381 Chamber, 382 Top section, 384 Bottom section, 1150 Distal catheter tip, 1152 Tubular body, 1154 Advancement segment, 1156 Marker band, 1158 Proximal segment, 1160 Inner tubular liner, 1162 Reinforcing element, 1164 Outer jacket, 1166 Angled surface, 1168 Leading sidewall section, 1172 Distal tip, 1174 Trailing sidewall section, 1176 Distal surface, 1178 Short sidewall, 1180 Long sidewall, 1182 Tension element, 1632 Sterility barrier, 1650 Driving mechanism, 1652 Driven mechanism, 1654 Mechanical linkage, 2100 Test system, 2102 Syringe, 2104 Hemostasis valve, 2106 Outer catheter, 2108 Inner catheter, 2200 Control mechanism, 2202 First control unit, 2204 Second control unit, 2206 Third control unit, 2208 Fourth control unit, 2210 Shaft, 2212 Distal bracket, 2214 Proximal bracket, 2216 Arrow, 2218 Arrow, 2220 Arrow, 2230 User, 2232 Arrow, 2234 Arrow, 2236 Arrow, 2238 Arrow, 2250 Arrow, 2254 Arrow, 2256 Arrow, 2258 Arrow, 2260 Arrow, 2900 Multi-catheter interventional device assembly, 2902 Insertion or access catheter, 2904 procedure catheter, 2906 guide catheter, 2907 guidewire, 2908 deflection control unit, 2909 guidewire hub, 2910 insertion or access catheter hub, 2912 procedure catheter hub, 2914 guide catheter hub, 3002 introducer sheath, 3004 iliac artery, 3006 aortic arch, 3014 brachiocephalic artery, 3016 internal carotid artery, 3018 petrous segment, 3020 clot, 4000 control system, 4002 processor, 4004 control unit, A angle, d distance between plates, h1 height, h2 height, L1 length, L2 length 、w1 width, x1 width, x2 width from the lateral edge of channel 205 to the lateral edge of channel 207, x3 width of support surface 204, x4 width of channel 206 and / or channel 212, y1 height of support surface 204, y2 height between the bottom of support surface 204 and top surface 233, y3 height of channel 206 and / or channel 212, α arc angle

Claims

1. 1. A drive system for achieving supra-aortic access and neurovascular treatment site access, comprising: a guidewire hub configured to adjust the axial and rotational position of the guidewire; a treatment catheter hub configured to adjust the axial position of the treatment catheter; a guide catheter hub configured to adjust the axial position of the guide catheter; an access catheter hub configured to adjust the axial and rotational position of the access catheter; a drive system including:

2. The drive system of claim 1 , wherein the treatment catheter hub is further configured to laterally deflect a distal deflection zone of the treatment catheter.

3. the guidewire hub is configured to couple to a guidewire hub adapter by magnetically coupling the guidewire hub to a first drive magnet; the access catheter hub is configured to couple to an access catheter hub adapter by magnetically coupling the access catheter hub to a second drive magnet; the guide catheter hub is configured to couple to a guide catheter hub adapter by magnetically coupling the guide catheter hub to a third drive magnet; 2. The drive system of claim 1, wherein the treatment catheter hub is configured to couple to a treatment catheter hub adapter by magnetically coupling the treatment catheter hub to a fourth drive magnet, and the first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet are independently movably carried by a drive table.

4. 4. The drive system of claim 3, further comprising a first driven magnet on the guidewire hub, the first driven magnet configured to cooperate with the first drive magnet such that the first driven magnet moves in response to movement of the first drive magnet.

5. 5. The drive system of claim 4, wherein the first drive magnet is configured to travel outside of the sterile field while being separated from the first driven magnet by a sterile field barrier while the first driven magnet is within the sterile field.

6. 5. The drive system of claim 4, wherein the position of the first drive magnet is movable in response to manipulation of a treatment drive control on a control console in electrical communication with the drive table.

7. the drive system further includes a second driven magnet on the access catheter hub, the second driven magnet configured to cooperate with the second drive magnet such that the second driven magnet moves in response to movement of the second drive magnet; 6. The drive system of claim 5, wherein the second drive magnet is configured to travel outside the sterile field while being separated from the second driven magnet by the barrier while the second driven magnet is within the sterile field.

8. the drive system further includes a third driven magnet on the guide catheter hub, the third driven magnet configured to cooperate with the third drive magnet such that the third driven magnet is configured to move in response to movement of the third drive magnet; 8. The drive system of claim 7, wherein the third drive magnet is configured to travel outside the sterile field while being separated from the third driven magnet by the barrier while the third driven magnet is within the sterile field.

9. the drive system further includes a fourth driven magnet on the treatment catheter hub, the fourth driven magnet configured to cooperate with the fourth drive magnet such that the fourth driven magnet is configured to move in response to movement of the fourth drive magnet; 9. The drive system of claim 8, wherein the fourth drive magnet is configured to travel outside the sterile field while being separated from the fourth driven magnet by the barrier while the fourth driven magnet is within the sterile field.

10. The drive system of claim 1 , wherein the treatment catheter is an aspiration catheter.

11. The drive system of claim 1 , wherein the treatment catheter is an embolism deployment catheter.

12. The drive system of claim 1 , wherein the treatment catheter is a stent deployment catheter.

13. The drive system of claim 1 , wherein the treatment catheter is a flow diverter deployment catheter.

14. The drive system of claim 1 , wherein the treatment catheter is a diagnostic angiography catheter.

15. The drive system of claim 1 , wherein the treatment catheter is a stent retriever catheter.

16. The drive system of claim 1 , wherein the treatment catheter is a balloon catheter.

17. The drive system of claim 1 , wherein the treatment catheter is a catheter for facilitating percutaneous valve repair or replacement.

18. The drive system of claim 1 , wherein the treatment catheter is an ablation catheter.

19. The drive system of claim 1 , wherein the treatment catheter hub is configured to adjust the rotational position of the treatment catheter.

20. The drive system of claim 1 , wherein the access catheter hub is configured to laterally deflect a distal deflection zone of the access catheter.

Images