Robotic drive system for enabling super-

Abstract

A drive system for effecting on-aortic access and neurovascular treatment site access includes a guidewire hub configured to adjust an axial position and a rotational position of a guidewire, a surgical catheter hub configured to adjust an axial position and a rotational position of a surgical catheter, a guide catheter hub configured to adjust an axial position and a rotational position of the surgical catheter, and an access catheter hub configured to access the surgical catheter. The guide catheter hub is configured to adjust an axial position of the guide catheter, and the access catheter hub is configured to adjust an axial position and a rotational position of the access catheter, the access catheter further configured to laterally deflect a distal deflection region of the access catheter.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] Pursuant to 37 CFR 1.57, any and all applications for which foreign and domestic priority claims are identified in the Application Data Sheet filed with the present application are hereby incorporated by reference. This application is an international application of and claims priority to the following applications: U.S. Application No. 18 / 060,935, filed on December 1, 2022, entitled “METHOD OF PRIMING AN INTERVENTIONAL DEVICE ASSEMBLY”, U.S. Application No. 18 / 073,291, filed on December 1, 2022, entitled “METHOD OF PRIMING CONCENTRICALLY STACKED INTERVENTIONAL DEVICES”, U.S. Application No. 17 / 959,924, filed on October 4, 2022, entitled “METHOD OF ROBOTICALLY DRIVING AMULTI CATHETER ASSEMBLY ABOVE THE AORTIC ARCH”, and U.S. Application No. 17 / 959,924, filed on October 4, 2022, entitled “ROBOTIC DRIVE SYSTEM FOR ACHIEVING SUPRA-AORTIC ARCH”. ACCESS”, U.S. Application No. 17 / 959,894, filed on October 4, 2022, entitled “METHOD OF PERFORMING A MULTI CATHETER ROBOTICNEUROVASCULAR PROCEDURE”, and U.S. Application No. 17 / 816,669, filed on August 1, 2022, entitled “METHOD OF SUPRA-AORTIC ACCESS FOR ANEUROVASCULAR PROCEDURE”.U.S. application No. 18 / 060,935, filed on December 1, 2022, entitled “METHOD OF PRIMING AN INTERVENTIONAL DEVICE ASSEMBLY,” is a continuation-in-part application of U.S. application No. 17 / 959,924, filed on October 4, 2022, entitled “METHOD OF ROBOTICALLY DRIVING A MULTI CATHETER ASSEMBLY ABOVE THE AORTIC ARCH,” U.S. application No. 17 / 959,894, filed on October 4, 2022, entitled “ROBOTIC DRIVE SYSTEM FOR ACHIEVING SUPRA-AORTIC ACCESS,” and U.S. application No. 17 / 960,014, filed on October 4, 2022, entitled “METHOD OF PERFORMING A MULTI CATHETER ROBOTIC NEUROVASCULAR PROCEDURE.” U.S. application No. 18 / 073,291 is a continuation-in-part of U.S. application No. 17 / 959,924, filed on October 4, 2022, entitled “METHOD OF ROBOTICALLY DRIVING A MULTI CATHETER ASSEMBLY ABOVE THE AORTICARCH,” U.S. application No. 17 / 959,894, filed on October 4, 2022, entitled “ROBOTIC DRIVE SYSTEM FOR ACHIEVING SUPRA-AORTIC ACCESS,” and U.S. application No. 17 / 960,014, filed on October 4, 2022, entitled “METHOD OF PERFORMING AMULTI CATHETER ROBOTIC NEUROVASCULAR PROCEDURE.” U.S. Application No. 17 / 959,924 is a continuation-in-part of U.S. Application No. 17 / 816,669, filed on August 1, 2022, entitled “METHOD OF SUPRA-AORTIC ACCESS FOR A NEUROVASCULAR PROCEDURE.” U.S. Application No. 17 / 959,894 is a continuation-in-part of U.S. Application No. 17 / 816,669, filed on August 1, 2022, entitled “METHOD OF SUPRA-AORTIC ACCESS FOR ANEUROVASCULAR PROCEDURE.”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 ANEUROVASCULAR PROCEDURE,” filed on August 1, 2022. The entire contents of each of the foregoing applications are incorporated herein by reference for all purposes and form a part of this specification. Technical Field

[0003] The present application relates to neurovascular surgery and, more particularly, to catheter assemblies and robotic control systems for accessing neurovascular sites. Background Art

[0004] A variety of neurovascular procedures can be performed via transvascular access, including thrombectomy, diagnostic angiography, embolic coil deployment, and stent placement. However, the delivery of neurovascular care is limited or delayed by multiple challenges. For example, there are not enough trained interventionalists and medical centers to meet the current demand for neurointervention. Neurointervention is difficult and places complex conditions and demands on the surgeon's dexterity. The surgeon must use two hands to precisely control 3 to 4 coaxial catheters while managing the fluoroscopic system and patient position. Long, curved anatomical structures require delicate, accurate manipulation. Due to the storage and release of energy caused by the frictional interaction between the coaxial axis and the patient's vascular system, inadvertent catheter movement may occur. It is challenging to achieve the supra-aortic access necessary to reach the neurovascular system, especially for type III arches. When supra-aortic access is achieved, adapting the system to neurovascular treatment is time-consuming and requires removing the guidewire and access catheter and adding the surgical catheter (and possibly one or more additional catheters) to the stack.

[0005] Therefore, there remains a need for a supra-aortic access and neurovascular site access system that addresses some or all of these challenges and increases the availability of neurovascular surgery. Preferably, the system is additionally capable of driving the device more distally through supra-aortic access to complete surgery in intracranial vessels. Summary of the invention

[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 each of the axial position and the rotational position of the guidewire; a guide catheter hub configured to adjust the guide catheter in the axial direction; and an access catheter hub configured to adjust each of the axial position and the rotational position of the access catheter. The access catheter hub can also laterally deflect the distal deflection region of the access catheter. The guidewire hub can additionally be configured to laterally deflect the distal portion of the guidewire.

[0007] A surgical catheter hub may also be provided that is configured to manipulate the surgical catheter. After robotic placement of the guidewire, access catheter, and guide catheter enables the guide catheter to achieve supra-aortic access, the guidewire and access catheter may be withdrawn proximally and the surgical catheter advanced through and beyond the guide catheter (with or without guidewire support (the guidewire may be smaller in diameter than the guidewire used to achieve supra-aortic access and / or more flexible than the guidewire used to achieve supra-aortic access)) to reach a more distal neurovascular treatment site. The surgical catheter may be an aspiration catheter; an embolization deployment catheter; a stent deployment catheter; a blood flow diverter deployment catheter, an access catheter; a diagnostic angiography catheter; a guide catheter, an imaging catheter, a physiological sensing / measurement catheter, an infusion or injection catheter, an ablation catheter, an RF ablation catheter or guidewire, a balloon catheter, or a microcatheter for delivering a stent retriever, a balloon catheter, or a stent retriever.

[0008] The control system can also include a driven magnet on each of the guidewire hub, the entry catheter hub and the guide catheter hub, and the driven magnet is configured to cooperate with the corresponding driving magnet so that the driven magnet moves in response to the movement of the corresponding driving magnet. The driving magnet can be independently carried by the support table and move axially. The driving magnet can be located outside the sterile area, separated from the driven magnet by a barrier, and the driven magnet can be within the sterile area. The barrier can include a tray made of a thin polymer film or a film of any non-ferromagnetic material.

[0009] The control system may also include a console that may be connected to the support table or may be located remotely from the support table. The position of each driven magnet and corresponding hub may be moved in response to manual operation of a guidewire drive control, an access catheter drive control, or a surgical catheter drive control on the console or on a specific controller not associated with the console.

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

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

[0012] Any one of the guidewire hub, the access catheter hub and the surgical catheter hub can also be equipped with a rotary driver for rotating the corresponding interventional device relative to the hub. The hub can also be equipped with an axial drive mechanism to advance to the far end or to retract the control element axially extending through the interventional device to the proximal end, to adjust the characteristics of the interventional device, such as shape or flexibility. In some embodiments, at least one control element can be an axially movable tubular body or fiber, ribbon or silk, such as extending through the interventional device to arrive at the silk of the distal deflection zone. In some embodiments, any number of control elements can be advanced, retracted or otherwise moved in a similar manner.

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

[0014] The control system may also include a deflection control configured to control deflection of the access catheter or the surgical 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 combined so that they drive corresponding devices at the same time and have the same motion. Alternatively, the control system can be configured to drive corresponding devices at the same time, but with different motions.

[0016] The control system may also include a physician interface for operating the control system. The physician interface may be carried by a support table having a drive system for the robotic interventional device. 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 also include a graphical user interface having at least one display for indicating a status of at least one device parameter, and / or indicating a status of at least one patient parameter.

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

[0019] In one embodiment, the sterile barrier is removably attached to the base to define a closed volume between the sterile barrier and the base. In another embodiment, the sterile barrier is in the form of a tubular closure for closing the sterile volume. The tubular closure can surround the base and at least one interventional device, and they are all within the sterile volume.

[0020] The hub can be oriented within the package so that the roller and magnet face the base. Alternatively, the base can be in the form of a tray with an elongated central axis. The upper sterile area side of the tray can have an elongated support surface for supporting and allowing one or more hubs to slide and move. At least one and optionally two elongated trays can be provided, extending parallel to the central axis. At least one hub and an interventional device can be provided in a tray, and a sterile tray with a sterile hub and an interventional device can be located in a sterile volume defined by a sterile barrier.

[0021] The base may be configured to be positioned on a support table adjacent to a patient, wherein an upper surface of the base is within the sterile field and a lower surface of the base is outside of the sterile field.

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

[0023] Any hub disclosed herein may also include a sensor for detecting a parameter of interest (e.g., the presence of a clot). In some cases, the sensor may be located on the flexible body. The sensor may include a pressure sensor or an optical sensor. In some embodiments, the sensor may include one or more of a force sensor, a positioning sensor, a temperature sensor, and / or an oxygen sensor. In some embodiments, the sensor may include a fiber Bragg grating sensor. For example, a fiber Bragg grating sensor (e.g., an optical fiber) may detect strain locally, which may facilitate detection and / or determination of the applied force. The device may also include a plurality of sensors. The plurality of sensors may each include one or more of any type of sensor disclosed herein. In some embodiments, a plurality of (e.g., 3 or more) sensors (e.g., fiber Bragg grating sensors) may be distributed around the border to facilitate detection and / or determination of the shape. In some cases, the position of the device may be determined by using one or more sensors to detect and / or determine the position. For example, one or more optical encoders may be located in or near one or more motors that drive linear motion so that the optical encoders may determine the position.

[0024] Also provided is a method of performing neurovascular surgery, wherein a first stage includes robotically achieving supra-aortic access, and a second stage includes manually or robotically performing the neurovascular surgery via supra-aortic access. The method includes the steps of providing an access catheter having an access catheter hub; connecting the access catheter hub to a hub adapter movably carried by a support table; driving 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 the access catheter hub may then be separated from the hub adapter; and a surgical catheter hub having a surgical catheter may then be connected to the hub adapter.

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

[0026] A method for performing neurovascular surgery is also provided, including the step of providing an access assembly including a guidewire, an access catheter, and a guide catheter. The access assembly can be releasably connected 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 achieving access on the aorta. The guidewire and access catheter can then be separated from the access assembly, leaving the guide catheter in place. A surgical assembly can be provided, which includes at least a guidewire and a first surgical catheter. The surgical assembly can be releasably connected to the robotic drive system; and the surgical assembly can be used to complete the neurovascular surgery. A second surgical catheter can also be provided for extending through the first surgical catheter to reach the treatment site.

[0027] The step of connecting the access assembly may include magnetically connecting a hub on each of the guide wire, the access catheter, and the guide catheter to separate a corresponding connector, the connector carrying a corresponding drive magnet independently and movably carried by the drive station. The surgical assembly may include a guide wire, a first catheter, and a second catheter. The guide wire and the first catheter may be concentrically located within the second catheter. The surgical assembly may be advanced as an assembly through at least a portion of the length of the guide catheter, and the surgery may include a neurovascular thrombectomy.

[0028] A method of performing a neurovascular procedure is also provided. The method includes the steps of providing a multi-catheter assembly including an access catheter, a guide catheter, and a surgical catheter, connecting 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, wherein the subset includes the guide catheter and the surgical catheter, proximally removing the access catheter, and performing the neurovascular procedure using the surgical catheter.

[0029] The neurovascular procedure may include a neurovascular thrombectomy. The assembly may also include a guidewire, wherein each of the guidewire, the access catheter, the guidewire catheter, and the surgical catheter is configured to be adjusted by a corresponding hub. Connecting the assembly to the robotic drive system may include magnetically connecting a first hub of the guidewire to a first drive magnet, magnetically connecting a second hub of the access catheter to a second drive magnet, magnetically connecting a third hub of the guide catheter to a third drive magnet, and magnetically connecting a fourth hub of the surgical catheter to a fourth drive magnet. Each of the first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet may be independently and movably carried by the drive station. The surgical catheter may be an aspiration catheter. The surgical catheter may be an embolization deployment catheter. The surgical catheter may be a stent deployment catheter. The surgical catheter may be a shunt deployment catheter. The surgical catheter may be a diagnostic angiography catheter. The surgical catheter may be a stent retriever catheter. The surgical catheter may be a clot retriever. The surgical catheter may be a balloon catheter. The surgical catheter may be a catheter that facilitates percutaneous valve repair or replacement. The surgical catheter may be an ablation catheter.

[0030] A method of performing a neurovascular procedure is also provided. The method includes the steps of providing an assembly including a guidewire, an access catheter, a guide catheter, and a surgical catheter, the assembly being coaxially movably assembled into a single multi-catheter assembly, connecting the assembly to a drive system, driving the assembly to achieve supra-aortic access, driving a subset of the assembly to an intracranial site, wherein the subset includes the guidewire, the guide catheter, and the surgical catheter, and performing a neurovascular procedure using the subset of the assembly.

[0031] Each of the guidewire, access catheter, guide catheter and surgical catheter can be configured to be adjusted by a corresponding hub. Connecting the assembly to the drive system can include magnetically connecting the first hub of the guidewire to the first drive magnet, magnetically connecting the second hub of the access catheter to the second drive magnet, magnetically connecting the third hub of the guide catheter to the third drive magnet, and magnetically connecting the fourth hub of the surgical catheter to the 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 and movably carried by a drive platform associated with the robotic drive system. Each of the first drive magnet, the second drive magnet, the third drive magnet and the fourth drive magnet can be independently and movably carried by the drive platform.

[0032] A method of performing neurovascular surgery is also provided. 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 connecting the guidewire hub to a first hub adapter, connecting the access catheter hub to a second hub adapter, and connecting the guide catheter hub to a third hub adapter, wherein each of the first hub adapter, the second hub adapter, and the third hub adapter is movably carried by a support table. The method also includes driving 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 achieve supra-aortic vascular access.

[0033] The method may include the step of driving a subset of the components along the support table until the subset of the components is positioned to perform a neurovascular procedure at a neurovascular treatment site, wherein the subset of the components includes a guidewire, a guide catheter, and a surgical catheter. The neurovascular procedure may include a thrombectomy. Connecting the guidewire hub to the first hub adapter may include magnetically connecting the guidewire hub to the first drive magnet. Connecting the access catheter hub to the second hub adapter may include magnetically connecting the access catheter hub to the second drive magnet. Connecting the guide catheter hub to the third hub adapter may include magnetically connecting the guide catheter hub to the 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 connected to the first driven magnet through the sterile field barrier. The second drive magnet may be connected to the second driven magnet through the sterile field barrier. The third drive magnet may be connected to the third driven magnet through the sterile field barrier. Connecting the guidewire hub to the first hub adapter may include mechanically connecting the guidewire hub to the first driver. Connecting the access catheter hub to the second hub adapter may include mechanically connecting the access catheter hub to the second driver. Connecting the guide catheter hub to the third hub adapter may include mechanically connecting the guide catheter hub to the third driver. After achieving supra-aortic access, the guidewire and guide catheter may be advanced as a combination along at least a portion of the length of the access catheter. The guidewire hub may be configured to adjust the axial position and rotational position of the guidewire. The assembly may also include a surgical catheter having a surgical catheter hub. The surgical catheter hub may be configured to adjust the axial position and rotational position of the surgical catheter. The surgical catheter hub may also be configured to laterally deflect the distal deflection region of the surgical catheter. The guidewire hub may be configured to adjust the axial position and rotational position of the guidewire. The surgical catheter hub may be configured to adjust the axial position and rotational position of the surgical catheter. The guide catheter hub may be configured to adjust the axial position of the guide catheter. The access catheter hub may be configured to adjust the axial position and rotational position of the access catheter. The surgical catheter hub may also be configured to laterally deflect the distal deflection region of the surgical catheter. The access catheter hub may also be configured to laterally deflect the distal deflection region of the access catheter. The guide catheter hub may be configured to adjust the axial position of the guide catheter. The access catheter hub can be configured to adjust the axial position and the rotational position of the access catheter.The access catheter hub can also be configured to laterally deflect the distal deflection region of the access catheter.

[0034] A drive system for achieving supra-aortic access and neurovascular treatment site access is also provided. The system includes: a guidewire hub configured to adjust the axial position and rotational position of the guidewire; a surgical catheter hub configured to adjust the axial position and rotational position of the surgical 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 position and rotational position of the access catheter.

[0035] The surgical catheter hub can also be configured to laterally deflect the distal deflection region of the surgical catheter. The guidewire hub can be configured to be connected to the guidewire hub adapter by magnetically connecting the guidewire hub to the first drive magnet. The entry catheter hub can be configured to be connected to the entry catheter hub adapter by magnetically connecting the entry catheter hub to the second drive magnet. The guide catheter hub can be configured to be connected to the guide catheter hub adapter by magnetically connecting the guide catheter hub to the third drive magnet. The surgical catheter hub can be configured to be connected to the surgical catheter hub adapter by magnetically connecting the surgical catheter hub to the 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 the drive station. The system can include a first driven magnet on the guidewire hub, which is configured to cooperate with the first drive magnet so that the first driven magnet moves in response to the movement of the first drive magnet. The first drive magnet can be configured to move outside the sterile area while being separated from the first driven magnet by the sterile area barrier, and the first driven magnet is within the sterile area. The position of the first drive magnet may move in response to operation of a surgical drive control on a console electrically connected to the drive station. The system may include a second driven magnet on the entry catheter hub, the second driven magnet being configured to cooperate with the second drive magnet so that the second driven magnet is configured to move in response to movement of the second drive magnet, wherein the second drive magnet is configured to move outside the sterile area while being separated from the second driven magnet by a barrier, while the second driven magnet is within the sterile area. The system may include a third driven magnet on the guide catheter hub, the third driven magnet being configured to cooperate with the third drive magnet so that the third driven magnet is configured to move in response to movement of the third drive magnet, wherein the third drive magnet is configured to move outside the sterile area while being separated from the third driven magnet by a barrier, while the third driven magnet is within the sterile area. The system may include a fourth driven magnet on the surgical catheter hub, the fourth driven magnet being configured to cooperate with the fourth drive magnet so that the fourth driven magnet is configured to move in response to the movement of the fourth drive magnet, wherein the fourth drive magnet is configured to move outside the sterile area while being separated from the fourth driven magnet by a barrier, and the fourth driven magnet is within the sterile area. The surgical catheter may be an aspiration catheter. The surgical catheter may be an embolization deployment catheter. The surgical catheter may be a stent deployment catheter. The surgical catheter may be a shunt deployment catheter. The surgical catheter may be a diagnostic angiography catheter. The surgical catheter may be a stent retriever catheter. The surgical catheter may be a balloon catheter. The surgical catheter may be a catheter that facilitates percutaneous valve repair or replacement. The surgical catheter may be an ablation catheter. The surgical catheter hub may be configured to adjust the rotational position of the surgical catheter. The entry catheter hub may be configured to laterally deflect the distal deflection region of the entry catheter.

[0036] A method of achieving supra-aortic access and neurovascular treatment site access is also provided. The method includes the step of providing a drive system, the drive system including: a guidewire hub configured to adjust the axial position and rotational position of the guidewire; a surgical catheter hub configured to adjust the axial position and rotational position of the surgical 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 position and rotational position of the access catheter, the access catheter also being configured to laterally deflect a distal deflection region of the access catheter, and move at least one of the guidewire hub, the surgical catheter hub, the guide catheter hub, and the access catheter hub to drive movement of at least one of the guidewire, the surgical catheter, the guide catheter, and the access catheter hub. The method may also include controlling the surgical catheter hub to laterally deflect the distal deflection region of the surgical catheter.

[0037] A method of achieving supra-aortic access is also provided. The method comprises the steps of providing an assembly including a guidewire, an access catheter, and a guide catheter, the assembly being coaxially and movably assembled into a single multi-catheter assembly, connecting the assembly to a drive system, driving the assembly to the aortic arch, and advancing the access catheter to achieve supra-aortic access to a branch vessel branching from the aortic arch.

[0038] The method may also include driving a subset of the components to an intracranial location and performing a neurovascular procedure using the subset of the components. The subset may include a guidewire, a guide catheter, and a surgical catheter. The surgical catheter may be an aspiration catheter. The surgical catheter may be an embolization deployment catheter. The surgical catheter may be a stent deployment catheter. The surgical catheter may be a shunt deployment catheter. The surgical catheter may be a diagnostic angiography catheter. The surgical catheter may be a stent retriever catheter. The surgical catheter may be a clot retriever. The surgical catheter may be a balloon catheter. The surgical catheter may be a catheter that facilitates percutaneous valve repair or replacement. The surgical catheter may be an ablation catheter. The intracranial procedure may include intracranial thrombectomy. The neurovascular procedure may include neurovascular thrombectomy. At least one of the guidewire, the access catheter, and the guide catheter may include a hub configured to be connected to a robotic drive system. Connecting the component to the drive system may include magnetically connecting the guide catheter hub to the drive system. Connecting the component to the drive system may include mechanically connecting the guide catheter hub to the drive system. The drive system may be a robotic drive system, and at least the first drive magnet, the second drive magnet, and the third drive magnet are each independently movably carried by a drive stage associated with the robotic drive system.

[0039] A method of pre-filling an interventional device assembly is also provided. The method includes providing an interventional device assembly, the interventional device assembly including a first interventional device connected to a first hub and a second interventional device connected to a second hub in a concentric stacked arrangement, the second interventional device being located within a lumen of the first interventional device. The method includes: connecting the interventional device assembly to a drive system while being arranged in a concentric stack; axially advancing the first interventional device and the first hub relative to the second hub to reduce an insertion depth 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 insertion depth of the second interventional device within the lumen of the first interventional device.

[0040] The drive system may be a robotic drive system. Axially advancing the first interventional device and the first hub relative to the second hub may include axially moving the first robotic drive connected to the first hub relative to the second robotic drive connected to the second hub. Axially advancing the first interventional device and the first hub relative to the second hub may 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 may be a first catheter, and the second interventional device may be a second catheter. The first catheter may be a guide catheter, the first hub may be a guide catheter hub, the second catheter may be a surgical catheter, and the second hub may be a surgical catheter hub. The interventional device assembly may include an access catheter connected to an access catheter hub arranged in a concentric stack, the access catheter being located within a lumen of the surgical catheter. The method may include: after flushing the guide catheter with a fluid, returning the guide catheter to an initial position relative to the surgical catheter; axially advancing the guide catheter, the guide catheter hub, the surgical catheter, and the surgical catheter hub relative to the access catheter hub to reduce the insertion depth of the access catheter within the lumen of the surgical catheter, while maintaining the distal end of the access catheter within the lumen of the surgical catheter and substantially maintaining the relative position between the guide catheter and the surgical catheter; and after reducing the insertion depth of the access catheter within the lumen of the surgical catheter, flushing the surgical catheter with a fluid. The interventional device assembly may include a guidewire connected to a guidewire hub arranged in a concentric catheter stack, the guidewire being located in the lumen of the access catheter. The method may include: after flushing the surgical catheter with a fluid, returning the guide catheter and the surgical catheter to an initial position relative to the access catheter; advancing the guide catheter, the guide catheter hub, the surgical catheter, the surgical catheter hub, the access catheter, and the access catheter hub axially relative to the guidewire hub to reduce the insertion depth of the guidewire in the lumen of the access catheter, while keeping the distal end of the guidewire in the lumen of the access catheter, and substantially maintaining the relative position between the guide catheter, the surgical catheter, and the access catheter; and flushing the access catheter with a fluid after the depth of the guidewire inserted into the lumen of the access catheter is reduced. The method may include flushing the second catheter with a fluid, wherein the steps of flushing the first catheter and flushing the second catheter are performed simultaneously. The fluid may be saline, a contrast agent, or a combination of saline and a contrast agent. The first interventional device may be a catheter, and the second interventional device may be a guidewire. The method may include 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 the first interventional device with a fluid after reducing the insertion depth of the second interventional device within the lumen of the first interventional device.

[0041] A method of prefilling a multi-catheter assembly is also provided. The method includes providing a multi-catheter assembly including a guidewire, an access catheter, a surgical catheter, and a guide catheter in a concentrically stacked configuration; connecting the multi-catheter assembly to a drive system; moving the guide catheter distally relative to the guidewire, the access catheter, and the surgical catheter; flushing the guide catheter with a fluid; and moving the guide catheter proximally toward the guidewire, the access catheter, and the surgical catheter.

[0042] The drive system may be a robotic drive system. The method may include moving the surgical catheter and the guide catheter distally relative to the guide wire and the access catheter, flushing the surgical catheter with a fluid, and moving the surgical catheter and the guide catheter proximally toward the guide wire and the access catheter. The method may include moving the access catheter, the surgical catheter, and the guide catheter distally relative to the guide wire, flushing the access catheter with a fluid, and moving the access catheter, the surgical catheter, and the guide catheter proximally toward the guide wire. The fluid may be saline, a contrast agent, or a combination of saline and a contrast agent. The guide wire may be connected to a guide wire hub. The access catheter may be connected to an access catheter hub. The surgical catheter may be connected to a surgical catheter hub. The guide catheter may be connected to a guide catheter hub. In a concentrically stacked configuration, the surgical catheter is located within the lumen of the guide catheter, the access catheter is located within the lumen of the surgical catheter, and the guide wire is located within the lumen of the access catheter. The method may include reciprocating at least one of the guide catheter and the surgical catheter relative to the other of the guide catheter and the surgical catheter while flushing the guide catheter with a fluid.

[0043] A method of pre-filling an interventional device assembly is also provided. The method includes providing an interventional device assembly, the interventional device assembly including a first interventional device and a second interventional device, the second interventional device being 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 interventional device and the second interventional device relative to the other of the first interventional device and the second interventional device may include 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 in response to a control signal. 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 may include reciprocating at least one of a first robotic drive connected to the first interventional device and a second robotic drive connected 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 interventional device and the second interventional device relative to the other of the first interventional device and the second interventional device may include reciprocating at least one of the first interventional device and the second interventional device axially relative to the other of the first interventional device and the second interventional device. 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 may also include reciprocating at least one of the first interventional device and the second interventional device rotationally relative to the other of the first interventional device and the second interventional device. Reciprocating at least one of the first interventional device and the second interventional device axially relative to the other of the first interventional device and the second interventional device may include reciprocating at least one of the first interventional device and the second interventional device axially relative to the other of the first interventional device and the second interventional device over a stroke length of about 10 mm to about 250 mm. Reciprocating at least one of the first interventional device and the second interventional device axially relative to the other of the first interventional device and the second interventional device may include reciprocating at least one of the first interventional device and the second interventional device axially relative to the other of the first interventional device and the second interventional device over a stroke length of about 25 mm to about 125 mm. Reciprocating at least one of the first interventional device and the second interventional device axially relative to the other of the first interventional device and the second interventional device may include reciprocating at least one of the first interventional device and the second interventional device axially relative to the other of the first interventional device and the second interventional device over a stroke length of more than 20 mm. Reciprocating at least one of the first interventional device and the second interventional device axially relative to the other of the first interventional device and the second interventional device may include reciprocating at least one of the first interventional device and the second interventional device axially relative to the other of the first interventional device and the second interventional device at a reciprocating frequency not exceeding about 5 Hz. The reciprocating frequency may not exceed about 1 Hz.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 may include reciprocating at least one of the first interventional device and the second interventional device rotationally relative to the other of the first interventional device and the second interventional device. 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 may include reciprocating the first interventional device and the second interventional device relative to each other. 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 may be performed by a robot-driven table. The first interventional device may be a first catheter and the second interventional device may be a second catheter. The first interventional device may be a catheter and the second interventional device may be a guidewire.

[0045] A method of prefilling a multi-catheter assembly is also provided. The method includes providing a multi-catheter assembly including a guidewire, an access catheter, a surgical catheter, and a guide catheter arranged in a concentric catheter stack, wherein the guidewire is located within a lumen of the access catheter, the access catheter is located within a lumen of the surgical catheter, the surgical catheter is located within a lumen of the guide catheter, and the guide catheter is flushed with saline while reciprocating at least one of the guide catheter and the surgical catheter relative to the other of the guide catheter and the surgical catheter.

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

[0047] A system for performing neurovascular surgery is also provided. The system includes an interventional device assembly, the 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. The system includes: a first hub adapter, wherein the guidewire hub is configured to connect to the first hub adapter; a second hub adapter, wherein the access catheter hub is configured to connect to the second hub adapter; a third hub adapter, wherein the guide catheter hub is configured to connect to the third hub adapter; and a support table, wherein each of the first hub adapter, the second hub adapter, and the third hub adapter is movably carried by the support table, wherein the first hub adapter, the second hub adapter, and the third hub adapter are configured to move along the support table to drive the interventional device assembly until the interventional device assembly is positioned to achieve supra-aortic vascular access.

[0048] The interventional device assembly may include a surgical catheter having a surgical catheter hub. The system may include a fourth hub adapter, wherein the surgical catheter hub is configured to be connected 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 surgical catheter to a position for performing a neurovascular surgery at a neurovascular treatment site. The neurovascular surgery may be a thrombectomy. The guidewire hub may be configured to be connected to the first hub adapter by magnetically connecting the guidewire hub to the first drive magnet. The entry catheter hub may be configured to be connected to the second hub adapter by magnetically connecting the entry catheter hub to the second drive magnet. The guide catheter hub may be configured to be connected to the third hub adapter by magnetically connecting the guide catheter hub to the third drive magnet. The first drive magnet, the second drive magnet, and the third drive magnet may be independently and movably carried by the support table. The first drive magnet may be connected to the first driven magnet through the sterile field barrier. The second drive magnet may be connected to the second driven magnet through the sterile field barrier. The third drive magnet may be connected to the third driven magnet through the sterile field barrier. The guidewire and guide catheter can be configured to be advanced as a combination along at least a portion of the length of the access catheter after achieving access on the aorta. The guidewire hub can be configured to adjust the axial position and rotational position of the guidewire. The interventional device assembly can include a surgical catheter having a surgical catheter hub. The surgical catheter hub can be configured to adjust the axial position of the surgical 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 position and rotational position of the access catheter. The surgical catheter hub can be configured to adjust the rotational position of the surgical catheter. The surgical catheter hub can be configured to laterally deflect the distal deflection region of the surgical catheter. The access catheter hub can be configured to laterally deflect the distal deflection region 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 using a control system in response to user input. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] Figure 1 is a schematic perspective view of an interventional setup with an imaging system, a patient support, and a robotic drive system according to the present disclosure.

[0050] Figure 2 is a longitudinal cross section showing the concentric relationship between a guidewire with two degrees of freedom, an access catheter with three degrees of freedom, and a guide catheter with one degree of freedom.

[0051] Figure 3A is an exploded schematic diagram of an interventional device hub separated from a support platform by a sterile barrier.

[0052] FIG. 3B to FIG. 3F An alternative sterile barrier is shown in the form of a transport tray having one or more storage channels for carrying interventional devices.

[0053] Figure 3G to Figure 3K An alternative sterile barrier embodiment is shown having a raised actuation surface.

[0054] Figure 3L and Figure 3M Describes the Figure 3G to Figure 3K Example of a hub used with a sterile barrier.

[0055] Figure 4 is a schematic elevational cross section through a hub adapter having a drive magnet separated from an interventional device hub and a driven magnet by a sterile barrier.

[0056] Figure 5A and Figure 5B A three- and four-interventional device assembly is schematically shown.

[0057] Figure 6 is a perspective view of the support table.

[0058] Figure 7 is a close-up view of the engine drive end of the support table.

[0059] Figure 8 is an elevation cross section through the engine and belt drive assembly.

[0060] Fig. 9 is a close-up view of the pulley end of the support table.

[0061] Fig.10 It is a vertical cross section through the pulley.

[0062] Fig.11 is throughout, for example Figure 5A and Figure 5B Elevation cross-section of the distal portion of those catheters shown in .

[0063] Fig. 12A and Fig. 12B A force sensor integrated into the side wall of a catheter is schematically shown.

[0064] Fig.13A and Fig. 13B A sensor for measuring the spring force of the magnetic connection between a hub and a corresponding pulley is schematically shown.

[0065] Fig.14 A dual encoder torque sensor for use with the catheter of the present disclosure is schematically shown.

[0066] Fig.15A clot capture and visualization device is shown that may be integrated into the hub and / or connected to the aspiration line.

[0067] FIG. 16A to FIG. 16C Exemplary control mechanisms for steering interventional devices driven by respective hubs are shown.

[0068] Fig.17 A schematic side elevation view of an interventional device assembly for supra-aortic access and neurointerventional procedures is shown.

[0069] 18A to 18E Depicted is an example sequence of steps for introducing a catheter assembly configured to achieve supra-aortic access and neurovascular site access.

[0070] Fig.19 An embodiment of a mechanical coupling between a driving mechanism and a driven mechanism is schematically shown.

[0071] FIG. 20A to FIG. 20C An example sequence of steps for priming a catheter assembly in a stacked configuration is depicted.

[0072] FIG. 21A to FIG. 21B An example sequence of steps for priming a catheter assembly in a stacked configuration is depicted.

[0073] Fig. 22 Describes the use FIG. 21A to FIG. 21B An example test system for the priming process depicted in FIG.

[0074] Fig.23A An example of a catheter assembly is shown.

[0075] Fig. 23B An example of a catheter assembly after a priming procedure is shown.

[0076] Fig.23C An example of a catheter assembly is shown after a priming procedure including relative movement between adjacent catheters.

[0077] FIG. 23D to FIG. 23F Shows FIG. 23A to FIG. 23C An example catheter assembly of FIG.

[0078] Fig.24 A schematic diagram of the control system is depicted. DETAILED DESCRIPTION

[0079] In certain embodiments, a system is provided for advancing a guide catheter from the femoral or radial artery into the ostium of one of the great vessels at the top of the aortic arch, thereby achieving supra-aortic access. The surgeon can then take the interventional device via the robotically placed guide catheter and advance it into the cerebrovascular system.

[0080] In some embodiments, the system can additionally be configured to robotically gain intracranial vascular access and perform aspiration thrombectomy or other neurovascular procedures.

[0081] The drive table can be located above or to one side of the patient and is configured to axially advance, retract, and in some cases rotate and / or laterally deflect two or three or more different (e.g., concentrically or side-by-side oriented) intravascular devices. The hub can move along a path along the surface of the drive table to advance or retract the interventional device as needed. Each hub can also contain a mechanism to rotate or deflect the device as desired and be connected to a fluid delivery tube (not shown) of the type conventionally attached to a catheter hub. Each hub can be in electrical communication with an electronic control system via a hardwired connection, an RF wireless connection, or a combination of both.

[0082] Each hub is independently movable on the surface of a sterile field barrier membrane carried by a drive table. Each hub is releasably magnetically connected to a unique drive trolley on the table side of the sterile field barrier. The drive system independently moves each hub in a proximal or distal direction on the surface of the barrier to move a corresponding interventional device proximally or distally within the patient's vascular system.

[0083] The pulley on the drive stage that is magnetically connected to the hub to provide linear motion actuation is universal. The catheter / guidewire functionality is provided based on what is included in the hub and shaft design. This allows the system to be flexibly configured to perform a wide range of surgeries using a variety of interventional devices on the same drive stage. In addition, the interventional devices and methods disclosed herein can be easily adapted for use with a variety of other drive systems (e.g., any of a variety of robotic surgical drive systems).

[0084] Figure 1 is a schematic perspective view of an interventional device 10 having a patient support table 12 for supporting a patient 14. An imaging system 16 may be provided along with a robotic interventional device drive system 18 according to the present disclosure.

[0085] The drive system 18 may include a support platform 20 for supporting, for example, a guidewire hub 26, an access catheter hub 28, and a guide catheter hub 30. In the context of this document, the term "access" catheter may be any catheter having a lumen with at least one distal opening facing distally or laterally that may be used to aspirate thrombus, provide a channel for additional devices to be advanced therethrough or along, or to infuse saline or contrast or therapeutic agents.

[0086] Depending on the desired clinical procedure, more or fewer interventional device hubs may be provided. For example, in certain embodiments, a diagnostic angiographic procedure may be performed using only the guidewire hub 26 and access catheter hub 28 for driving a guidewire and access catheter (in the form of a diagnostic angiographic catheter). A plurality of interventional devices 22 extend between the support table 20 and (in the example shown) a femoral access point 24 on the patient 14. Depending on the desired procedure, access may be achieved by percutaneous or open access to any of a variety of arteries or veins, such as the femoral artery or radial artery. Although disclosed herein primarily in the context of neurovascular access and surgery, the robotic drive systems and associated interventional devices can be readily configured for a wide variety of additional medical interventions in the peripheral and coronary arterial and venous vascular systems, the gastrointestinal system, the lymphatic system, cerebrospinal fluid cavities or spaces (e.g., the vertebral canal, ventricles, and subarachnoid space), the pulmonary airways, treatment sites reached via transureteral or urethral or fallopian tube navigation, or other hollow organs or structures in the body (e.g., in intracardiac or structural heart applications, such as valve repair or replacement, or in any intracavitary surgery).

[0087] A display 23 (e.g., for viewing fluoroscopic images, catheter data (e.g., fiber Bragg grating fiber sensor data or other force or shape sensing data), or other patient data) may be carried by the support table 20 and / or the patient support 12. Alternatively, a physician input / output interface including the display 23 may be remote from the patient, such as behind a radiation shield, in a different room from the patient, or in a different facility from the patient.

[0088] In the example shown, a guidewire hub 26 is carried by the support table 20 and is movable along the table to advance a guidewire into and out of the patient 14. An access catheter hub 28 is also carried by the support table 20 and is movable along the table to advance an access catheter into and out of the patient 14. The access catheter hub may also be configured to rotate the access catheter in response to operation of a rotation control, and may also be configured to laterally deflect a deflectable portion of the access catheter in response to operation of a deflection control.

[0089] Figure 2 is a longitudinal cross section schematically showing the kinematic relationship between a guidewire 27 having two degrees of freedom (axial and rotational), an access catheter 29 having three degrees of freedom (axial, rotational and lateral deflection), and a guide catheter 31 having one degree of freedom (axial).

[0090] refer to Figure 3A, the support platform 20 includes a drive mechanism described in more detail below to independently drive the guidewire hub 26, the access catheter hub 28, and the guide catheter hub 30. An anti-buckling feature 34 can be provided in the proximal anti-buckling region for resisting buckling of the portion of the interventional device that spans the distance between the support platform 20 and the femoral artery access point 24. The anti-buckling feature 34 can include a plurality of concentric, telescopically extending and collapsible tubes through which the interventional device extends.

[0091] Alternatively, the proximal section of one or more device shafts can be configured to have enhanced rigidity to reduce buckling during compression. For example, the segment of proximal reinforcement can extend from the hub to a distance of at least about 5 cm or 10 cm distally, but usually no more than about 120 cm or 100 cm, to support the device between the hub and the entry point 24 on the patient. Reinforcement can be achieved by using a metal or polymer tube or embedding at least one or two or more axially extending elements into the wall of the device shaft, such as a long wire or ribbon. In some embodiments, the extension element can be hollow and prevent the wear, buckling or damage at the input and output of the hub. In some embodiments, the hollow extension element can be a hollow and flexible covering layer attached to the hub. The hollow extension element (for example, a hollow and flexible covering layer) can cover a part of the device shaft when passing through the hub. In some embodiments where the hollow extension element is a covering layer, the coating can be attached to a part of the hub so that the catheter device is passed through the hub 26, 28 or 30 and the catheter device is also passed through the covering layer. In some embodiments, an anti-buckling device can be mounted on or around the device shaft to avoid misalignment or insertion angle errors between hubs or between hubs and insertion points. The anti-buckling device can be a laser cut hypotube, a spring, a telescoping tube, a split tube with tension, etc.

[0092] In some embodiments, multiple deflection sensors can be placed along the length of the catheter to identify buckling. Identifying buckling can be performed by sensing that the hub is advanced distally without the distal tip of the catheter or interventional device moving. In some embodiments, buckling can be detected by sensing that energy loading has occurred between the catheter shafts (e.g., due to friction).

[0093] Alternatively, a thin tubular reinforcement structure can be embedded in the device wall or continue outside the device wall, such as a tubular polymer extrusion or a section of hypotube. Alternatively, a removable reinforcing mandrel can be placed in the lumen in the proximal section of the device and removed from the proximal end after the hub is advanced distally toward the patient access position to prevent the buckling of the proximal shaft during the distal advancement of the hub. Alternatively, the proximal section of one or more device shafts can be configured as a tubular hypotube, which can be machined (e.g., with a laser) so that its mechanical properties vary along its length. The proximal section can be formed of stainless steel, nitinol and / or cobalt-chromium alloy, optionally in combination with a polymer component that can provide lubricity and hydraulic sealing. In some embodiments, the proximal section can be formed of a polymer, such as polyetheretherketone (PEEK). Alternatively, the wall thickness or diameter of the interventional device can be increased in the anti-buckling region.

[0094] In certain embodiments, a device shaft having a high degree of stiffness (e.g., axial and torsional) can provide improved motion transfer from the proximal end of the device shaft to the distal end of the device shaft. For example, the device shaft can be more responsive to motion applied at the proximal end. Such an embodiment may be advantageous for robotic actuation without tactile feedback to the user.

[0095] In some embodiments, a flexible covering layer can be applied to the device shaft and / or hub to reduce friction between the device shaft and / or hub and the second device shaft as the second device shaft passes through the device shaft and / or hub and the second device shaft.

[0096] The interventional device hub can be separated from the support platform 20 by a sterile barrier 32. The sterile barrier 32 may include a thin plastic film, such as polyethylene terephthalate (PET), polyethylene terephthalate glycol copolymer (PETG), polyethylene terephthalate (PETE), high-density polyethylene (HDPE), polyvinyl chloride (PVC), low-density polyethylene (LDPE), polypropylene (PP), polystyrene (PS) or styrene. This allows the support platform 20 and the associated drive system to be located on the non-sterile (lower) side of the sterile barrier 32. The guidewire hub 26, the entry catheter hub 28, the guide catheter hub 30 and the associated interventional device are all on the sterile (upper) side of the sterile barrier 32. The sterile barrier is preferably waterproof and can also be used as a tray used in the packaging of the interventional device, which will be discussed further below. The interventional device can be provided separately or as a coaxial pre-assembled kit, which is transported and stored in a tray and packaged in a sterile package.

[0097] FIG. 3B to FIG. 3FSchematically shown is an optional sterile barrier in the form of a dual-function sterile barrier placed on a support table during an interventional procedure, and a transport tray having one or more storage channels for carrying sterile interventional devices. The sterile barrier can also be used as a sterile work surface for the preparation of catheters or other devices during surgery.

[0098] refer to Figure 3B and Figure 3C , a sterile barrier 32 in the form of a preformed tray is shown for mounting the elongated support table 20. In use, the elongated support table 20 will be located below the sterile barrier 32. The sterile barrier 32 extends between a proximal end 100 and a distal end 102 and includes an upper support surface 104 for supporting an interventional device hub. In one embodiment, in a linear drive configuration, the support surface 104 has an axial length that is greater than the length of the intended interventional device.

[0099] The length of the support surface 104 will typically be at least about 100 centimeters, and in the range of about 100 centimeters to about 2.7 meters. Shorter lengths may be used in systems configured to advance the drive connector along an arc path. In some embodiments, two or more support surfaces may be used instead of a single support surface 104. The two or more support surfaces may have a combined length of 100 centimeters to about 2.7 meters. The width of the linear drive table is preferably no more than about 30 centimeters to about 80 centimeters.

[0100] At least a first channel 106 may be provided that extends axially for at least a portion of the length of the support platform 20. In the illustrated embodiment, the first channel 106 extends the entire length of the support platform 20. Preferably, the first channel 106 has sufficient length to accommodate the interventional device and has sufficient width and depth to accommodate the corresponding hub (e.g., by providing lateral support to prevent the hub from moving out when force is applied to the hub). The first channel 106 is defined within the bottom plate 108, the outer side wall 110, and the inner side wall 111, forming an upwardly facing concave shape. Optionally, a second channel 112 may be provided. The second channel 112 may be located on the same side of the upper support surface 104 as the first channel 106 or on the opposite side. Two or three or more additional recesses (e.g., additional channels or holes) may be provided to accommodate additional medical devices or supplies useful during the interventional procedure, as well as to collect fluids and serve as a wash basin for catheters and related devices.

[0101] refer to Figure 3D, guide catheter hub 30 is shown positioned on upper support surface 104 and magnetically connected to a corresponding connector housing a drive magnet, which connector is positioned below sterile barrier 32. Access catheter hub 28 and access catheter 29, as well as guidewire hub 26 and guidewire 27 are shown positioned within first channel 106, such as before introduction through guide catheter 31 or after removal from guide catheter 31.

[0102] The interventional devices may be located within the channel 106 and enclosed within the sterile barrier for transport. At the clinical location, the upper panel of the sterile barrier may be removed, or the tubular sterile barrier packaging may be opened and axially removed from the support table 20 and sterile barrier assembly 32, exposing the sterile top side of the sterile barrier tray and any included interventional devices. The interventional devices may be carried individually in the channel, or preassembled into an access assembly or a surgical assembly, which will be discussed in additional detail below.

[0103] Figures 3D to 3F A support table is shown with a sterile barrier in place and Figure 3E In, the intervention device is configured in the access assembly, for the aorta to enter after the access assembly is connected to the corresponding pulley below the sterile barrier. The access assembly can be preassembled, wherein the guide wire is fully advanced through the access catheter, and the access catheter is fully advanced through the guide catheter. In the access catheter or other catheters are preformed (that is, pre-bent or not straight) embodiments, the guide wire and / or the outer catheter can be positioned so that the relatively hard part does not overlap with the harder part of the bend of the preformed catheter, for example, to avoid the creep of the preformed catheter or straightening and / or the bending is introduced into other straight catheters. The access assembly can be lifted out of the passage 106 and positioned on the support surface 104, for being connected to the corresponding driving magnet and being introduced into the patient. The guide catheter hub 30 is the most distal hub. The access catheter hub 28 is located at the proximal end of the guide catheter hub, so that the access catheter 29 can be extended to the distal end by the guide catheter. The guide wire hub 26 is located at the most proximal end, so as to allow the guide wire 27 to be advanced through the access catheter 29 and the guide catheter 31.

[0104] Figure 3F The surgical components are shown after they have been introduced through a guide catheter 31 for achieving supra-aortic access. In this embodiment, the guide catheter 31 remains at the distal-most end of the interventional device. A first surgical catheter 120 and a corresponding hub 122 are shown extending through the guide catheter 31. An optional second surgical catheter 124 and a corresponding hub 126 are shown extending through the first surgical catheter 120. A guidewire 27 extends through at least a portion of the second surgical catheter 124 in a rapid exchange version of the second surgical catheter 124, or through the entire length of the second surgical catheter 124 in an over-the-wire embodiment.

[0105] As combined Fig.17 Discussed in more detail, multiple catheter stacks can be used to achieve access and intravascular surgery without the need to replace catheters. This can be done in manual or robotically driven surgery. In one example, the guide catheter 31 can include a catheter with an inner diameter of at least about 0.08 inches, and in one embodiment, an inner diameter of about 0.088 inches. The first surgical catheter 120 can include a catheter with an inner diameter of about 0.065 inches to about 0.075 inches, and in one embodiment, the catheter 120 has an inner diameter of about 0.071 inches. The second surgical catheter 124 can be an entry catheter with an OD size that allows advancement through the first surgical catheter 120. The second surgical catheter can be manipulable, having a deflection control 2908 configured to deflect the distal end of the catheter laterally. The second surgical (entry) catheter can also have a lumen, the size of which allows a guide wire of appropriate size to remain inside the second surgical catheter while angiography is injected through the second surgical catheter.

[0106] In certain embodiments, catheter 31 can be a "large bore" access catheter or guide catheter having a diameter of at least about 0.075 inches or at least about 0.080 inches. Catheter 120 can be an aspiration catheter having a diameter of about 0.060 to about 0.075 inches. Catheter 124 can be a steerable catheter having a deflectable distal tip having a diameter of about 0.025 inches to about 0.050 inches. Guidewire 27 can have a diameter of about 0.014 to about 0.020 inches. In one example, catheter 31 can have a diameter of about 0.088 inches, catheter 120 can have a diameter of about 0.071 inches, catheter 124 can have a diameter of about 0.035 inches, and guidewire 27 can have a diameter of about 0.018 inches.

[0107] In one commercial implementation, a preassembled access assembly (a guide catheter, an access catheter, and a guidewire) can be carried in a first channel on a sterile barrier tray, and a preassembled surgical assembly (one or two surgical catheters and a guidewire) can be carried in the same or different second channel on the sterile barrier tray. One or two or more additional catheters or interventional tools can also be provided, depending on potential needs during the interventional procedure.

[0108] Figure 3G to Figure 3K An embodiment of an alternative sterile barrier having a convex drive surface (eg, a convex, raised road-like drive surface) is shown. Figure 3G2 is a cross-sectional view of sterile barrier 232. Sterile barrier 232 includes a convex upper support surface 204. Fluid channels 205 and 207 are located laterally of support surface 204 and below support surface 204 for automatically clearing or draining fluid from support surface 204 (e.g., during an interventional procedure). Fluid channels 205 and 207 may extend axially over at least a portion of the length of the sterile barrier.

[0109] Fig. 3I , Figure 3J and Figure 3K A perspective cross-sectional view, a cross-sectional view, and a top cross-sectional view of the proximal end of the sterile barrier 232 are shown, respectively. FIG. 3I to FIG. 3K As shown, the sterile barrier 232 may include a groove 240 in communication with the fluid channels 205 and 207. The groove 240 may receive fluid from the channels 205 and 207 (e.g., during an interventional procedure). The groove 240 may be at least partially located below the fluid channels 205 and 207 so that the fluid in the channels 205 and 207 flows into the groove 240. In some embodiments, the fluid channels 205 and 207 may be at an angle relative to the horizontal plane (e.g., may descend from the end of the channel farthest from the groove 240 to the groove 240) so that the fluid in the channels 205 and 207 is directed to the groove 240. For example, the depth of the channels 205 and 207 may increase from the end of the channel farthest from the groove 240 to the groove 240. Alternatively, during a portion or all of the interventional procedure, sterile barrier 232 and / or support table may be positioned at an angle relative to the horizontal plane such that the ends of channels 205 and 207 farthest from slot 240 are positioned above slot 240. For example, sterile barrier 232 and / or support table may be constructed or arranged at an angle such that the ends of sterile barrier 232 and / or support table opposite slot 240 are positioned above slot 240. Alternatively or additionally, the drive mechanism may temporarily tilt sterile barrier 232 and / or support table such that the ends of sterile barrier 232 and / or support table opposite slot 240 are positioned above slot 240 (e.g., by lifting the ends of sterile barrier 232 and / or support table opposite slot 240, or lowering the ends of sterile barrier 232 and / or support table at the location of slot 240) such that fluid within channels 205 and 207 flows into slot 240.

[0110] The tank 240 may include a drain hole 242. The tank 240 may be shaped, sized, and / or otherwise configured as desired so that the fluid in the tank 240 drains into the drain hole 242. The drain hole 242 may include a pipe, a barbed fitting, and / or a switch valve for removing the fluid from the tank 240. FIG. 3I to FIG. 3KAs shown, the groove 240 can be located at the proximal end of the sterile barrier 232. In an alternative embodiment, the groove 240 can be located at the distal end of the sterile barrier 232. In some embodiments, the sterile barrier 232 can include a first groove 240 at the proximal end and a second groove 240 at the distal end. In some embodiments, the groove 240 can also be used as a wash basin.

[0111] The first channel 206 can extend axially for at least a portion of the length of the sterile barrier 232. The channel 206 can have sufficient length to accommodate the interventional device and have sufficient width and depth to accommodate the corresponding hub (e.g., by providing support to prevent the hub from moving out when force is applied to the hub). Optionally, a second channel 212 can be provided. The second channel 212 can be located on the same side of the upper support surface 204 as the first channel 206 or on the opposite side. Figure 3G Channel 212 is shown on the opposite side of support surface 204 from channel 206 . Figure 3H is a cross-sectional view illustrating an alternative embodiment of sterile barrier 232 in which channel 212 is on the same side of support surface 204 as channel 206 .

[0112] like Figure 3G and Figure 3H As shown, channels 206 and 212 can have a generally triangular, wedge-shaped or other angled cross-section to accommodate the hub at an angle relative to the horizontal plane. Accommodating the hub at an angle relative to the horizontal plane can allow for a sterile barrier 232 of a smaller width.

[0113] Two or three or more additional recesses (eg, additional channels or holes) may be provided to accommodate additional medical devices or supplies that may be useful during an interventional procedure, as well as to collect fluids and serve as a wash basin for catheters and associated equipment.

[0114] In some embodiments, the sterile barrier 232 can include one or more structural ribs 236. The sterile barrier 232 can also include one or more frame support protrusions 228 and 238.

[0115] exist Figure 3G In the embodiment of the sterile barrier 232 shown, the width x1 can be 14 in, about 14 in, 12 in to 16 in, 10 in to 18 in, or any other suitable width. Figure 3HIn the embodiment of the sterile barrier 232 shown, the width x1 can be 15 inches, about 15 inches, 13 inches to 17 inches, 11 inches to 19 inches, or any other suitable width. The height y1 of the support surface 204 can be 0.125 inches, about 0.125 inches, 0.1 inches to 0.15 inches, or any other suitable height. In some embodiments, the support surface 204 can be recessed from the top surface 233 of the sterile barrier 232. The height y2 between the bottom and top surface 233 of the support surface 204 can be 0.5 inches, about 0.5 inches, 0.25 inches to 0.75 inches, or any other suitable height. The width x2 from the lateral edge of the passage 205 to the lateral edge of the passage 207 can be 5 inches, about 5 inches, 4 inches to 6 inches, or any other suitable width. The width x3 of the support surface 204 can be 4 inches, about 4 inches, 3 inches to 5 inches, or any other suitable width. The height y3 of channel 206 and / or channel 212 can be 1.5in, about 1.5in, 1in to 2in, or any other suitable height. The width x4 of channel 206 and / or channel 212 can be 3in, about 3in, 2in to 4in, or any other suitable width. Channel 206 and / or channel 212 can be defined by an arc angle α of 90°, about 90°, 80° to 100°, or any other suitable angle, and a radius of curvature of 0.125in, about 0.125in, 0.1in to 0.15in, or any other suitable radius of curvature. In certain embodiments, an arc angle α of 90° or about 90° can be used to accommodate a hub with a rectangular or substantially rectangular cross section. Support surface 204 can be defined by a radius of curvature of 13in, about 13in, 11in to 15in, or any other suitable radius of curvature. Channel 205 and / or channel 207 may be defined by a radius of curvature of 0.25 in, approximately 0.25 in, 0.15 in to 0.35 in, or any other suitable radius of curvature.

[0116] Figure 3L and Figure 3M Describes how Figure 3G to Figure 3KThe example size of the hub 250 used together with the sterile barrier 232 shown.The hub 250 can be any hub as described herein.In certain embodiments, the hub 250 can have a width w1 of 3.75in, about 3.75in, 3.25in to 4.25in, or any other suitable width.The hub 250 can have a height h1 of 1.5in, about 1.5in, 1.25in to 1.75in, or any other suitable height.Selectively, the hub 250 can have a height h2 of 2in, about 2in, 1.75in to 2.25in, or any other suitable height.In some embodiments, the hub 250 can have a length L1 of 2.5in, about 2.5in, 2in to 3in, or any other suitable length.Selectively, the hub 250 can have a length L2 of 4in, about 4in, 3.5in to 4.75in, or any other suitable length.

[0117] In some embodiments, the top surface of the support table can include surface features that generally correspond to the surface features of the sterile barrier 232. For example, the support table can include a raised surface configured to correspond to the shape, size, and position of the support surface 204 and / or one or more recesses configured to correspond to the shape, size, and position of the channels 205 and 207.

[0118] In an optional embodiment, the planar support surface (e.g., support surface 104 of sterile barrier 32) can be positioned at an angle to the horizontal plane to facilitate the discharge of fluid. In some embodiments, during a portion or the entirety of the interventional procedure, the sterile barrier and / or support table can be positioned at an angle relative to the horizontal plane to facilitate the discharge of fluid. For example, the sterile barrier and / or support table can be constructed or arranged to be arranged at an angle (e.g., such that one lateral side of the planar support surface is higher than the other lateral side of the planar support surface, the proximal end is higher than the distal end, or the distal end is positioned higher than the proximal end) to facilitate the discharge of fluid. Alternatively or additionally, the drive mechanism can temporarily tilt the sterile barrier and / or support table (e.g., such that one lateral side of the planar support surface is higher than the other lateral side of the planar support surface, the proximal end is higher than the distal end, or the distal end is positioned higher than the proximal end) to facilitate the discharge of fluid. For example, the drive mechanism may raise or lower a lateral side of the sterile barrier and / or support table, a proximal end of the sterile barrier and / or support table, and / or a distal end of the sterile barrier and / or support table.

[0119] In certain embodiments, a support surface (e.g., support surface 104 of sterile barrier 32) may be positioned in a vertical configuration, rather than, for example, FIG. 3A to FIG. 3FFor example, the support surface 104 can be positioned at about 90 degrees (or any other suitable angle) to the horizontal plane (e.g., relative to FIG. 3A to FIG. 3F 104 is rotated 90 degrees about the long axis of the support surface 104). The vertical configuration can also provide easier physician interaction with the drive system 18. The vertical configuration can also provide the lower shaft of the catheter to be advanced closer to the patient without increasing the standoff height of the drive system 18.

[0120] In some embodiments, the drive system 18 can be positioned at an angle to the horizontal plane during a portion or all of the interventional procedure to facilitate the discharge of fluid. For example, the drive system 18 can be configured or arranged in an angled arrangement (e.g., such that one lateral side of the planar support surface is higher than the other lateral side of the planar support surface, the proximal end is higher than the distal end, or the distal end is positioned higher than the proximal end) to facilitate the discharge of fluid. Alternatively or additionally, the drive mechanism can temporarily tilt the drive system 18 (e.g., such that one lateral side of the drive system 18 is higher than the other lateral side of the drive system 18, the proximal end is higher than the distal end, or the distal end is positioned higher than the proximal end) to facilitate the discharge of fluid. 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 axis point 24 (e.g., such that the proximal end is higher than the distal end), for example, to reserve clearance for the patient's foot.

[0121] refer to Figure 4 , the hub 36 can represent any hub 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 interventional device disclosed herein, extends distally from the hub 36 and enters the patient 14 (not shown). The hub adapter 48 or pulley acts as a shuttle by advancing proximally or distally along a track in response to an operator command or controller operation. The hub adapter 48 includes at least one drive magnet 67 configured to be connected to a driven magnet 69 carried by the hub 36. This provides a magnetic connection between the drive magnet 67 and the driven magnet 69 through the sterile barrier, so that the hub 36 moves on the top of the sterile barrier 32 in response to the movement of the hub adapter 48 outside the sterile area. The movement of the hub adapter is driven by a drive system carried by the support table and is described in additional detail below. The hub adapter can be used as a robot drive for an interventional device connected thereto.

[0122] In order to reduce friction in the system, the hub 36 can be equipped with at least a first roller 53 and a second roller 55, which can be in the form of wheels or rotatable balls or drums. The rollers separate the sterile barrier from the surface of the driven magnet 69 by at least about 0.02 cm (about 0.008 inches), and generally do not exceed about 0.08 cm (about 0.03 inches). In some embodiments, the gap is in the range of about 0.03 cm (about 0.010 inches) to about 0.041 cm (about 0.016 inches). The gap between the driving magnet 67 and the driven magnet 69 is generally no more than about 0.38 cm (about 0.15 inches), and in some embodiments no more than about 0.254 cm (about 0.10 inches), for example, in the range of about 0.216 cm (about 0.085 inches) to about 0.229 cm (about 0.090 inches). The hub adapter 48 may similarly be equipped with at least a first hub adapter roller 59 and a second hub adapter roller 63, which may be positioned relative to the corresponding first roller 53 and second roller 55, such as Figure 4 shown.

[0123] refer to Figure 6 , schematically illustrates one example of a low profile linear drive support table 20. The support table 20 includes an elongated frame 51 extending between a proximal end 52 and a distal end 54. At least one support table support 56 is provided to stabilize the support table 20 relative to a patient (not shown). The support 56 may include one or more legs, or preferably an articulated arm configured to allow the frame 51 to be moved and positioned above or near a patient.

[0124] Figure 7 One example of the linear drive table 20 shown includes three different drives. However, depending on the desired clinical performance, two drives or four or more drives (e.g., up to eight drives) may be included. The first drive pulley 58 is engaged with the first drive belt 60. The first pulley bracket 61 is fixed to the first drive belt 60 so that rotation of the first drive pulley 58 causes the first drive belt 60 to rotate through an elongated closed loop path. Depending on the direction of rotation of the drive pulley 58, the first pulley bracket 61 can be advanced in the proximal or distal direction along the longitudinal axis of the support table 20. In the embodiment shown, the drive pulley 58 is equipped with a surface structure, such as a plurality of drive pulley teeth 62, for engaging with complementary teeth on the first drive belt 60.

[0125] The second drive pulley 64 can be engaged with a second drive belt 66, which is configured to axially move a second trolley bracket 68 along an axial path on the support table 20. The third drive pulley 70 can be configured to drive a third drive belt 72 to axially advance a third trolley bracket 73 along the support table 20. Each trolley bracket can be equipped with the previously discussed but not Figure 7 , to form a connector for magnetically connecting to a corresponding driven magnet within the hub of the interventional device, as already discussed.

[0126] Figure 8 Detailed views of the drive system are schematically shown. The drive support 74 can be carried by the frame 51 for supporting the drive assembly. The second drive pulley 64 is shown in the elevation cross section as being driven by the engine 75 via a rotatable shaft 76. The rotatable shaft 76 can be rotatably carried by the support 74 via the first bearing 78, the shaft connection 80 and the second bearing 79. The engine 75 can be stabilized by the engine bracket 82 connected to the drive support 74 and / or the frame 51. The belt drive assembly for the first drive belt 60 and the third drive belt 72 can be similarly constructed, and this article will not be described in detail in addition. In some embodiments, the drive system described herein can be a foldable rack and pinion drive table system. In such an embodiment, the engine 75 can be attached to the pulley and move with the pulley.

[0127] refer to Fig. 9 and Fig.10 , each of the first, second and third drive belts extends around the corresponding first idler wheel 84, second idler wheel 86 and third idler wheel 88. Each idler wheel can be equipped with a corresponding tension bracket 90, which is configured to adjust the idler wheel in the proximal or distal direction to adjust the tension of the corresponding belt. Therefore, each tension bracket 90 is equipped with a tension adjustment member 92, such as a rotatable screw.

[0128] like Fig.10 As shown, for example, the second idler gear 86 may be carried by a rotatable shaft 94 that is rotatably fixed relative to the mounting bracket via a first bearing 96 and a second bearing 98 .

[0129] Any catheter (e.g. Figure 5A , Figure 5B or Fig.11 The catheter shaft of the present invention is generally comprised of an elongated tubular body extending between a proximal end and a distal functional end. The length and diameter of the tubular body depends on the desired application. For example, a length of about 90 cm to about 195 cm or longer is generally used for femoral access percutaneous transluminal coronary applications. Intracranial or other applications may require different catheter shaft lengths depending on the vascular access site.

[0130] Any of the catheters disclosed herein may be equipped with a beveled distal tip. Fig.11, the distal catheter tip 1150 includes a tubular body 1152 including a pusher section 1154, a marker band 1156, and a proximal section 1158. An inner tubular liner 1160 may extend throughout the entire length of the distal catheter tip 1150 and may include dip-coated or extruded PTFE or other lubricating material.

[0131] A reinforcement element 1162 (eg, braid and / or spring coils) is embedded in an outer sheath 1164, which can extend the entire length of the catheter.

[0132] The pusher section 1154 terminates at a beveled surface 1166 at the distal end to provide a front sidewall portion 1168 having a length measured between the distal end 130 of the marker band 1156 and the distal tip 1172. In some embodiments, the entire distal tip can have a shape that avoids the tip from getting stuck in the arterial bifurcation region. The rear sidewall portion 1174 of the pusher section 1154 has an axial length in the illustrated embodiment that is approximately equal to the axial length of the front sidewall portion 1168, which is measured from the front sidewall portion 1168 about 180 degrees around the catheter. The axial length of the front sidewall portion 1168 can be about 0.1 mm to about 5 mm, and is typically about 1 mm to 3 mm. The rear sidewall portion 1174 can be equal to the axial length of the front sidewall portion 1168 or at least about 0.1 mm or 0.5 mm or 1 mm or 2 mm or less shorter than the axial length of the front sidewall portion 1168, depending on the desired performance.

[0133] The inclined surface 1166 is inclined at an angle A of about 45 degrees to about 80 degrees to the longitudinal axis of the catheter. For some embodiments, the angle is about 55 degrees to about 65 degrees to the longitudinal axis of the catheter. In one embodiment, angle A is about 60 degrees. One result of an angle A of less than 90 degrees is an elongation of the major axis of the region of the distal port, which increases the surface area of ​​the port and can enhance clot aspiration or retention. Compared to the surface area of ​​a circular port (angle A is 90 degrees), the area of ​​the inclined port is typically at least about 105% and no more than about 130%, in some embodiments, about 110% to about 125%, and in one example, about 115% of the area of ​​the corresponding circular port (angle A is 90 degrees).

[0134] In the illustrated embodiment, the axial length of the advancement section remains constant around the circumference of the catheter so that the inclined surface 1166 is generally parallel to the distal surface 1176 of the marker band 1156. The marker band 1156 has a proximal surface that is generally transverse to the longitudinal axis of the catheter, thereby producing an internal elevation view of the marker band 1156 having a right-angled trapezoidal configuration. The short sidewall 1178 is rotationally aligned with the rear sidewall portion 1174 and has an axial length of about 0.2 mm to about 4 mm, and typically about 0.5 mm to about 2 mm. The opposing long sidewall 1180 is rotationally aligned with the front sidewall portion 1168. The long sidewall 1180 of the marker band 1156 is typically at least about 10% or 20% longer than the short sidewall 1178, and can be at least about 50% or 70% or 90% or more longer than the short sidewall 1178, depending on the desired performance. Typically, long sidewalls 1180 will have a length of at least about 0.5 mm or 1 mm and less than about 5 mm or 4 mm.

[0135] The marker band may be a continuous annular structure or may have at least one and optionally two or three or more axially extending slits throughout its entire length. The slits may be located on the short sidewall 1178 or the long sidewall 1180 or between the two, depending on the desired bending characteristics. The marker band may include any of a variety of radiopaque materials, such as a platinum / iridium alloy, and preferably has a wall thickness of no more than about 0.003 inches, and in one embodiment about 0.001 inches.

[0136] When using multiple catheters, the perspective appearance of the marker band can be unique or different for each catheter size or type, so that the marker band can be distinguished from each other by a software algorithm. When using multiple catheters together, for example, in a multi-catheter assembly or stacking as described herein, it may be advantageous to distinguish the marker bands of multiple catheters. In some embodiments, the marker band of a catheter can be configured to enable a software algorithm to detect the motion of the catheter tip.

[0137] The marker band region of the assembled catheter can have a relatively high bending stiffness and high crush strength, e.g., at least about 50% less or at least about 100% less than the proximal segment 1158, but typically no more than about 200% less than the proximal segment 1158. The high crush strength can provide radial support for the adjacent pusher segment 1154, and in particular for the anterior sidewall portion 1168, to facilitate the distal tip 1172 to function as an atraumatic buffer during transluminal advancement and prevent collapse under vacuum. The proximal segment 1158 preferably has a lower bending stiffness than the marker band region, and the pusher segment 1154 preferably has an even lower bending stiffness and crush strength than the proximal segment 1158.

[0138] The advancement section 1154 may include an outer tubular sheath 1164 and an optional distal extension of the inner liner 1160 without other internal support structures distal to the marker band 1156. The outer sheath 1164 may include an extruded polyurethane, such as The advancement segment 1154 may have a bending stiffness and a radial crush stiffness that is no more than about 50%, and in some embodiments no more than about 25%, or 15%, or 5%, or less, of the corresponding values ​​of the proximal segment 1158.

[0139] The catheter can also include an axial tension element or support, such as a ribbon or one or more filaments or fibers, for increasing tension resistance and / or affecting bending properties in the distal region. The tension support can include one or more axially extending single or multiple filaments. One or more tension elements 1182 can be placed axially within the catheter wall near the distal end of the catheter. One or more tension elements 1182 can be used as tension supports and prevent the tip of the catheter wall from detaching or extending in a tensioned state (for example, when the catheter is retracted proximally through a kinked outer catheter or a tortuous or narrowed vascular system).

[0140] At least one of the one or more tension elements 1182 can extend proximally along the length of the catheter wall from within approximately 1.0 centimeters of the distal end of the catheter to less than approximately 10 centimeters of the distal end of the catheter, less than approximately 20 centimeters of the distal end of the catheter, less than approximately 30 centimeters of the distal end of the catheter, less than approximately 40 centimeters of the distal end of the catheter, or less than approximately 50 centimeters of the distal end of the catheter.

[0141] One or more tension elements 1182 can have a length of greater than or equal to approximately 40 centimeters, greater than or equal to approximately 30 centimeters, greater than or equal to approximately 20 centimeters, greater than or equal to approximately 10 centimeters, or greater than or equal to approximately 5 centimeters.

[0142] At least one of the one or more tension elements 1182 can extend at least approximately up to 50 centimeters of the length of the catheter, extend at least approximately up to 40 centimeters of the length of the catheter, extend at least approximately up to 30 centimeters or 20 centimeters or 10 centimeters of the length of the catheter.

[0143] In some embodiments, the tensile element extends proximally from the distal end of the catheter along the length of the coil 24 and terminates proximally at about 5 cm or 2 cm or less on either side of the transition between the distal coil and the proximal braid. The tensile element may terminate at the transition without overlapping the braid.

[0144] One or more tension elements 1182 may be placed adjacent to or radially outside of the liner 1160. One or more tension elements 1182 may be placed adjacent to or radially inside of the braid and / or coil. One or more tension elements 1182 may be carried between the liner 1160 and the helical coil and may be secured to the liner or other underlying surface by an adhesive prior to adding the next outer adjacent layer (e.g., coil). Preferably, the tension element 1182 is secured to the marker band 1156, for example, by an adhesive or by mechanical interference. In one embodiment, the tension element 1182 extends distally beyond the marker band on a first (e.g., inner) surface of the marker band, then wraps around the distal end of the marker band and extends along a second (e.g., outer) surface in one or both of the proximal oblique or circumferential directions to completely wrap around the marker band.

[0145] When more than one tension element 1182 or filament bundle is circumferentially spaced apart in the catheter wall, the tension elements 1182 can be placed in a radially symmetrical manner. For example, the angle between two tension elements 1182 relative to the radial center of the catheter can be about 180 degrees. Alternatively, depending on the desired clinical performance (e.g., flexibility, trackability), the tension elements 1182 can be placed 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 about 180 degrees, less than or equal to about 165 degrees, less than or equal to about 135 degrees, less than or equal to about 120 degrees, less than or equal to about 90 degrees, less than or equal to about 45 degrees, or less than or equal to about 15 degrees.

[0146] The one or more tension elements 1182 may include materials such as: or any combination thereof. At least one of the one or more tension elements 1182 may include a single fiber or a bundle of multiple fibers, and the fibers or bundles may have a circular or rectangular (e.g., ribbon) cross-section. The terms fiber or filament do not convey composition, and they may include any of a variety of high tensile strength polymers, metals, or alloys, depending on design considerations such as desired tensile failure limit and wall thickness. The cross-sectional dimension of one or more tension elements 1182 measured in the radial direction may not exceed approximately 2%, 5%, 8%, 15%, or 20% of the cross-sectional dimension of the catheter 10.

[0147] The cross-sectional dimension of one or more tension elements 1182 measured in the radial direction may be no more than about 0.03 mm (about 0.001 inch), no more than about 0.0508 mm (about 0.002 inch), no more than about 0.1 mm (about 0.004 inch), no more than about 0.15 mm (about 0.006 inch), no more than about 0.2 mm (about 0.008 inch), or about 0.38 mm (about 0.015 inch).

[0148] One or more tension elements 1182 can increase the tensile strength of the distal region of the catheter to at least about 1 pound, at least about 2 pounds, at least about 3 pounds, at least about 4 pounds, at least about 5 pounds, at least about 6 pounds, at least about 7 pounds, at least about 8 pounds, or at least about 10 pounds or more before failing under tension (e.g., the marker band detaches).

[0149] Any of a variety of sensors may be provided on any of the catheter, hub, pulley, or table, depending on the desired data. For example, in some embodiments, it may be desirable to measure, for example, axial tension or compression applied to the catheter along the force sensing region. The distal end of the catheter will be manufactured to have a Fig.11 , and having a helical coil distal portion. However, unlike a single helical coil using a nitinol wire, the first conductor 140 and the second conductor 142 are wound into helical coils that are wound around each other and are electrically insulated from each other, for example, by the plastic / resin of the tubular body. Fig. 12A Each coil is in electrical communication with the proximal hub via a unique electrical conductor (eg, a conductive line of wire or a proximal extension).

[0150] This construction of two electrically isolated spiral coils creates a capacitor. This is roughly equivalent to two Nitinol plates with a plastic layer between them, such as Fig. 12B As shown. The capacitance is inversely proportional to the distance between the wires. The only variable that will change will be d, the distance between the plates. If an axial compressive force is applied to the catheter, the wires (e.g., conductor 140 and conductor 142) will move closer together, thereby increasing the capacitance. If an axial tensile force is applied, the wires will move further apart, reducing the capacitance. The capacitance can be measured at the proximal end of the catheter, giving a measure of the force at the spiral capacitor. Although referred to as a capacitor, the sensor measures the electrical interaction between the coils of two wires. There may be a measurable change in inductance or other resulting change due to the applied axial force.

[0151] At least the first helical capacitor may have at least one or five or ten or more complete rotations per wire. The capacitor may be located within the distal-most 5 cm or 10 cm or 20 cm of the catheter body to sense the forces experienced at the distal end. At least a second capacitor may be provided within the proximal-most 5 cm or 10 cm or 20 cm of the catheter body to sense the forces experienced at the proximal end of the catheter.

[0152] It may also be desirable to measure the elastic force across the magnetic connection between the hub and the corresponding trolley using the natural elasticity (compliance) of the magnetic connection to measure the force applied to the hub. The magnetic connection between the hub and trolley creates a spring. When a force is applied to the hub, the hub will move a small amount relative to the trolley. See Fig.13A In robotics, this is called a series elastic actuator. This property can be used to measure the force applied from the sled to the hub. To measure the force, the relative distance between the hub and the sled is determined ( Fig.13A dx) and characterizes some effective spring constant k between the two components. Fig. 13B .

[0153] The relative distance can be measured in a variety of different ways. One method for measuring the relative distance between the hub and the pulley is a magnetic sensor (e.g., a Hall effect sensor between the hub and the pulley). A magnet is mounted to the hub or the pulley, and a corresponding magnetic sensor is mounted on the other device (the pulley or the hub). The magnetic sensor can be a Hall effect sensor, a magnetoresistive sensor, or other type of magnetic field sensor. Typically, multiple sensors can be used to increase the reliability of the measurement. This reduces noise and reduces interference from external magnetic fields.

[0154] Other non-contact distance sensors may also be used. These sensors include optical sensors, inductive sensors, and capacitive sensors. The optical sensor will preferably be configured in a manner to avoid accumulation of blood or other fluids in the interface between the hub pulley. In some embodiments, for example, a wireless (i.e., inductive) power source may be used to convert movement and / or transmit information across the sterile barrier between the drive pulley and the hub.

[0155] The magnetic connection between the hub and the pulley has a shear or axial fracture threshold, which can be approximately 300 grams or 1000 grams or greater. The processor can be configured to compare the axial force applied to the catheter to a preset axial trigger force, which is perceived as creating a risk to the patient if the preset axial trigger force is applied to the catheter. If the trigger force is reached, the processor can be configured to generate a response to the physician (e.g., visual, auditory, or tactile feedback), and / or intervene and shut down further advancement of the catheter until resetting is achieved. An override function can be provided so that the physician can choose to continue advancing the catheter at a force above the trigger force if the physician believes that an increase in force is reasonable.

[0156] Force and / or torque sensing optical fibers (e.g., fiber Bragg grating (FBG) sensors) can be built into the catheter sidewall to measure forces and / or torques at various locations along the axis of the catheter, or alternatively can be integrated into the guidewire. The fiber measures axial strain, which can be converted into axial force or torque (when helically wound). At least a first FBG sensor can be integrated into a distal sensing region, a proximal sensing region, and / or an intermediate sensing region on the catheter or guidewire to measure forces and / or torques near the sensor.

[0157] It may also be desirable to understand the three-dimensional configuration of a catheter or guidewire during and / or after transvascular placement. Shape sensing optical fibers, such as arrays of FBG optical 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.

[0158] Resistive strain gauges may be integrated into the body of a catheter or guidewire to measure force or torque, for example at the distal tip and / or proximal end of the device.

[0159] The measurement of the force and / or torque applied to the catheter or guidewire shaft can be used to determine the applied force and / or torque above a safety threshold. When the applied force and / or torque exceeds the safety threshold, a warning can be provided to the user. The applied force and / or torque measurement can also be used to provide feedback related to better catheter operation and control. The applied force and / or torque measurement can also be used with processed fluoroscopic imaging information to determine or characterize distal tip motion.

[0160] The absolute position of the hub (and corresponding catheter) along the length of the table can be determined in a variety of ways. For example, a non-contact magnetic sensor can be configured to measure the position of the hub directly through a sterile barrier. The same type of sensor can also be configured to measure the position of the trolley. Each hub can have at least one magnet attached to it. The robotic table will have a linear array of corresponding magnetic sensors that pass through the entire length of the table. The processor can be configured to determine the position of the magnet along the length of the linear sensor array and display the axial position information to the physician.

[0161] Alternatively, the above purpose can be accomplished by directly measuring the position of the hub through a sterile barrier using a non-contact inductive sensor. Each hub or trolley can be equipped with an inductive "target" therein. The robotic table can be equipped with an inductive sensing array over the entire working length of the table. As another option, an absolute linear encoder can be used to directly measure the linear position of the hub or trolley. The encoder can use any of a variety of different technologies, including optical, magnetic, inductive, and capacitive methods.

[0162] In one embodiment, a passive (no electrical connection) target coil may be carried by each hub. A linear printed circuit board (PCB) may run throughout the working length of the table (e.g., at least about 1.5 meters to about 1.9 meters), the linear printed circuit board being configured to interrogate an interrogator signal that excites a return signal from the passive coil. The PCB is configured to identify the return signal and its location.

[0163] The axial position of the trolley can be determined using a multi-turn rotary encoder to measure the rotational position of the pulley, which is directly related to the linear position of the trolley. Alternatively, direct measurement of the trolley position can be accomplished by recording the number of steps commanding a stepper motor to measure the rotational position of the pulley, which is directly related to the linear position of the trolley.

[0164] The position of the catheter and guidewire within the anatomical structure can also be determined by processing the fluoroscopic images with machine vision, for example, to determine the distal tip position, distal tip orientation, and / or guidewire shape. Comparing the distal tip position or movement or its lack thereof with the command 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 results (e.g., along the length of the device shaft inside the body (e.g., in the aorta) or outside the body between the hubs. Processing can be performed in real time to provide position / orientation data up to 30 Hz, although this technology can only provide data when fluoroscopic imaging is turned on. In some embodiments, machine vision algorithms can be used to generate and suggest optimal catheter operations to approach or reach anatomical landmarks, similar to driver assistance. Machine vision algorithms can use data to automatically drive the catheter based on the anatomical structure presented by the fluoroscopic examination.

[0165] A dual encoder torque sensor can be used to determine the proximal torque applied to a catheter or guidewire shaft. Fig.14 , the first encoder 144 and the second encoder 146 can be axially spaced apart along the axis 148 to measure the angular difference over the length of the flexible catheter / tube. Since the catheter / tube has a known torsional stiffness, the angular difference is interpolated as the torque. When torque is applied to the shaft, the slightly flexible portion of the shaft will twist. The difference between the angles measured by the encoders (dθ) tells us the torque. T = k*dθ, where k is the torsional stiffness.

[0166] Confirming that there are no bubbles in the fluid line can also be accomplished using a bubble sensor, particularly in situations where the physician is remote from the patient. This can be accomplished using a non-contact ultrasonic sensor that measures the intensity and Doppler shift of reflected ultrasound through the sidewalls of the fluid conduit to detect bubbles and measure fluid flow rate or fluid level. The ultrasonic or optical sensor can be located near the incoming fluid flow path within the hub, or in a supply line leading to the hub. In order to detect the presence of bubbles in an infusion line (formed from an ultrasonic or optically transmissive material), the sensor can include a signal source on a first side of the flow path and a receiver on a second side of the flow path to detect bubbles by measuring the transmission of liquid through the tube. Alternatively, due to the relatively high echogenicity of bubbles, the reflected ultrasonic signal can be detected from the same side of the flow path as the source.

[0167] Preferably, the bubble removal system is automatically activated when bubbles are detected in the line. The processor can be configured to activate a valve in the flow path downstream of the bubble detector when bubbles are detected. The valve diverts a column of fluid from the flow path to the patient and into the reservoir. When bubbles are no longer detected in the flow path, and after the volume of fluid in the flow path between the detector and the valve has passed through the valve, the valve can be activated to reconnect the fluid source to the patient through the flow path. In other embodiments, the bubble removal system may include a pump and a control system upstream of the bubble detector for removing bubbles in the line. The processor can be configured to activate the pump when bubbles are detected to reverse the fluid flow and clear the bubbles into a waste reservoir before reestablishing bubble-free forward flow.

[0168] Furthermore, it is desirable for the physician to be able to view the aspirated clot at a location within the sterile field, and preferably as close to the patient as possible for fluid management purposes. This can be accomplished by providing a clot retrieval device mounted on the hub, or by providing a clot retrieval device mounted in the aspiration line away from the hub in the direction of the pump. Fig.15 One example of a clot retrieval device 370 may include a body 380 enclosing a chamber 381 that communicates with the first port 310 and the second port 320 .

[0169] In some embodiments, the body 380 includes a housing having a top portion 382 and a bottom portion 384. The body 380 can include a filter 330 located between the top portion 382 and the bottom portion 384 in the chamber 381. In some examples, the first port 310 is configured to connect to a first end of a first tube 340 that is fluidly connected to a proximal end of the aspiration catheter.

[0170] In an embodiment configured to connect downstream from the hub, the first tube 340 includes a connector 342 at a second end of the first tube 340 that is configured to engage or mate with a corresponding connector on the hub or configured to engage or mate with a corresponding connector in communication with the hub. The first port 310 communicates directly with a chamber on the upstream (e.g., top side) of the filter, and the second port 320 communicates directly with a chamber on the downstream (e.g., bottom side) of the filter to facilitate direct visualization of material captured on the upstream side of the filter.

[0171] In embodiments configured for remote operation, any of a variety of sensors may be provided to detect clots passing through the aspiration line and / or trapped in the filter, such as optical sensors, pressure sensors, flow rate sensors, ultrasonic sensors, or other sensors known in the art.

[0172] In some embodiments, the second port 320 is configured to connect to a first end of a second tube 350, which is fluidly connected to a suction source (e.g., a pump). In some embodiments, the second tube 350 includes a connector 352 at a second end of the second tube 350, which is configured to engage or mate with a corresponding connector on the pump.

[0173] In some examples, the system 300 may include a switch valve 360, such as a clamp 360. The clamp 360 may be located between the filter 330 and the patient, such as on the first tube 340, to allow the user to engage the clamp and provide flow control by isolating the patient from the clot removal device 370. Closing the valve 360 ​​and operating a remote vacuum pump (not shown) causes the canister associated with the vacuum pump and the chamber 381 to reach the same low pressure. Due to the short distance and small line volume of the lumen between the chamber 381 and the distal end of the catheter, a sharp negative pressure spike is quickly experienced at the distal end of the catheter after opening the valve 360. Additional details are disclosed in U.S. Patent No. 11,259,821 entitled "Aspiration System with Accelerated Response" granted to Buck et al. on March 1, 2022, the entire contents of which are expressly incorporated herein by reference. In some embodiments, the vacuum can circulate the clot to recycle the clot. The vacuum can be automatically and robotically controlled to remove the clot.

[0174] The body 380 can have a top surface spaced apart from the bottom surface by a tubular sidewall. In the illustrated embodiment, the top and bottom surfaces are substantially circular and spaced apart by a cylindrical sidewall. The top surface can have a diameter that is at least about three times, or five times or more, than the axial length of the sidewall (transverse to the top and bottom surfaces) to produce a generally disc-shaped housing. Preferably, at least a portion of the top wall is optically transparent to improve visualization of the clot after the clot is captured in the clot recovery device 370. Additional details can be found in U.S. Patent Application No. 63 / 256,743, the entire contents of which are incorporated herein by reference.

[0175] In some examples, the body 380 may include a flush port (not shown) configured to allow an optically transparent medium, such as air, saline, or other fluid, to be injected into the chamber 381 to clear the optical path between the window and the filter to improve visualization of the clot once it is trapped in the filter 330.

[0176] The foregoing represents certain specific embodiments of drive stages and associated components and catheters. A wide variety of different drive stage structures can be manufactured for supporting and axially advancing and retracting two or three or four or more drive magnet assemblies to robotically drive interventional devices, fluidic elements, and electrical umbilical elements for transmitting electrical signals and fluids to the catheter hub, as will be understood by those skilled in the art in view of the disclosure herein. Additional details can be found in U.S. Patent Application No. 17 / 527,393, the entire contents of which are hereby incorporated herein by reference.

[0177] Although the foregoing describes a robotically driven interventional device and a manually driven interventional device, the device may be manually driven, robotically driven, or a combination of manually and robotically driven interventional devices, as will be understood by those skilled in the art in view of the disclosure herein.

[0178] FIG. 16A to FIG. 16C An example control mechanism 2200 is shown for manipulating interventional devices driven by (or otherwise associated with) a respective hub. For example, each hub may be manipulated and / or otherwise moved using at least one control mounted in the control mechanism 2200. Each control may be adapted to move a unique hub-associated interventional device during an interventional procedure.

[0179] like Fig.16AAs shown, the control mechanism 2200 includes a first control 2202, a second control 2204, a third control 2206, and a fourth control 2208. More or fewer controls may be provided depending on the intended interventional device configuration. Each control 2202 to 2208 is movably carried on a shaft 2210, which is connected to a distal support 2212 and a proximal support 2214. The controls 2202 to 2208 can be advanced distally or retracted proximally on the shaft 2210, as indicated by arrows 2218 and 2216. In addition, each control 2202 to 2208 can also rotate about the shaft 2210, as indicated by arrow 2220. Each control movement can trigger a corresponding movement in a corresponding pulley on the support table, which in turn can drive movement of the corresponding hub, as already discussed.

[0180] The control mechanism 2200 can be located on or near a patient support table having a set of hubs and catheter / interventional devices. In some embodiments, the control mechanism 2200 can be located remotely from the support table, such as behind a radiation shield or in a different room or different geographic location in a telemedicine embodiment.

[0181] Each control member 2202 to 2208 can correspond to a hub and / or a combination of a hub and an interventional device and drive its movement. For example, the control member 2202 can be configured to drive the hub 30 ( Figure 3F ) to move an interventional device, such as a 0.088 inch guide catheter corresponding to hub 30. Similarly, control 2204 can be configured to drive hub 28 (122) to move an interventional device, such as a 0.071 inch surgical catheter. Control 2206 can be configured to drive hub 126 to move an interventional device, such as a steerable access catheter. Control 2208 can be configured to drive hub 26 to axially and rotationally move an interventional device, such as a guidewire.

[0182] Fig. 16B An example of manually manipulating a control 2202 on a control mechanism 2200 is shown. In operation, if a user 2230 moves the control 2202 axially and distally along the axis 2210, as indicated by arrow 2232, the corresponding connected hub and / or interventional device may responsively move in the same direction by the same or proportional amount. If the user 2230 rotates the control 2202 about the axis 2210 and advances the control proximally, as indicated by arrow 2234, the corresponding connected interventional device will correspondingly rotationally and proximally move by the same or proportional amount. If the user 2230 rotationally moves the control 2202 about the axis 2210, as indicated by arrow 2236 or arrow 2238, the corresponding connected hub will rotationally drive the corresponding interventional device in the same direction and / or by the same or proportional amount.

[0183] Other axes and degrees of freedom may be defined to enable movement of the control member 2202 that can be translated into movement of the hub and / or interventional device. For example, the control mechanism may be equipped with one or more deflection controls configured to initiate lateral deflection in a deflection region on a corresponding interventional device.

[0184] The axial movement of the control can be configured to move the connected hub on a 1: 1 basis or on a non-1: 1 scaled basis. For example, if the user 2230 advances the control 2022 about 5 mm distally along the shaft 2210, the corresponding hub can correspondingly move 5 mm in the distal direction.

[0185] If the user 2230 rotates the control 2022 about its rotational axis by 5 degrees, the connected hub will rotate the corresponding interventional device on a 1: 1 basis or on a non-1: 1 scaled basis. The amount of scaling can be selected to reduce or increase the distance the hub and / or interventional device moves and the amount of rotation in response to the control movement.

[0186] In some embodiments, a scaling factor can be used to determine the amount of scaling described herein. The scaling factor can be applied to one or both of the translational and rotational movements. In some embodiments, a first scaling factor is selected for the translational movement, and a second scaling factor different from the first scaling factor is selected for the rotational movement. For a given proximal or distal operation of a control member, the axial scaling factor can drive the proximal catheter movement at a faster speed than the distal catheter movement.

[0187] The rotational scaling factor may be 1:1, while the axial scaling factor may cause the hub to move a greater distance than the control member such that hub travel relative to control member travel is at least about 2:1 or 5:1 or 10:1 or greater, depending on the desired axial length of the control assembly.

[0188] The control mechanism 2200 can be configured to enable the clinician to adjust the scaling factors for different parts of the procedure. For example, distal advancement of the surgical catheter and access catheter through the guide catheter and up to the selected port may be ideally accomplished in a "fast" mode. However, more distal advancement into the neurovascular system may be ideally accomplished in a relatively slow mode through actuation of the speed control.

[0189] In another embodiment, one or more controls can be configured to gradually drive the advancement or retraction speed of the corresponding hub and associated catheter. For example, the distal control 2202 can drive the guide catheter. Slight distal movement of the control 2202 can advance the guide catheter distally at a slower speed, while advancing the control 2202 distally over a greater distance increases the rate of distal travel of the guide catheter.

[0190] Controlling the speed of the corresponding hubs axially or axially and rotationally can increase the overall speed of the procedure. For example, advancement of various devices from a femoral entry point to the aortic arch can be desirably accomplished at a faster rate than distal navigation closer to the treatment site. Also, proximal retraction of various devices, particularly guidewires, access catheters, and surgical catheters can be desirably accomplished at a relatively higher rate than distal advancement.

[0191] Fig. 16C Another example of manually operating a control on a control mechanism 2200 to move a hub and / or other interventional device is shown. In some embodiments, two or more controls 2202 to 2208 can be moved in combination to trigger movement of one or more hubs and / or associated interventional devices. In the depicted example, a user 2230 moves control 2204 and control 2206 in combination (e.g., sequentially, simultaneously) to simultaneously move a 0.088 guide catheter and a 0.071 aspiration catheter as a combination. An example movement of control 2204 can include axial proximal movement in the direction indicated by arrow 2250. Sequentially or simultaneously, a user 2230 can move control 2206 axially in either direction indicated by arrows 2254 and 2256, while also being able to rotationally move control 2206 in either direction indicated by arrows 2258 and 2260.

[0192] In some embodiments, each control mechanism and / or additional controls (not shown) can be color coded, shape coded, tactile coded, or otherwise coded to indicate to the user 2230 which color is configured to move which hub or interventional device. In some embodiments, control color coding can also be applied to the hubs and / or interventional devices so that the user can visually match a particular hub / device with a particular control.

[0193] In some embodiments, controls 2202-2208 can be used to perform other control operations in addition to translational and rotational movement. For example, controls 2202-2208 can be configured to drive a shape change and / or a stiffness change of a corresponding interventional device. Controls 2202-2208 can be switched between different modes of operation. For example, controls 2202-2208 can be switched between movement driven by acceleration and velocity and movement reflecting actual linear displacement or rotation.

[0194] In some embodiments, the control mechanism 2200 can be equipped with a visual display or other indicator of the relative position of the control members, which can correspond to the relative position of the interventional devices. Such a display can depict any or all directions of movement, instructions, percentages of movement performed, and / or hub and / or catheter indicators to indicate which device is controlled by a particular control member. In some embodiments, the display can depict the applied force or resistance encountered by the catheter or other measurement detected or observed by a particular hub or interventional component.

[0195] In some embodiments, the control mechanism 2200 can include a haptic component to provide tactile feedback to a user operating the control. For example, if the control 2202 triggers movement of the catheter and the catheter detects a large force at the tip, the control 2202 can generate tactile feedback to indicate to the user to stop or reverse the movement in progress. In some embodiments, tactile feedback can be generated at the control to indicate to the user to slow down or speed up the movement using the control. In some embodiments, the haptics can provide feedback on the accumulation of large torsional strains that may precede a sudden rotation, or can provide feedback on the accumulation of large axial forces that may be a prelude to catheter buckling.

[0196] The system described herein can compare the actual perspective image position with the input displacement from the controller. A static perspective image of the patient can be captured, in which the patient's vascular system is indicated relative to a bone landmark or one or more implanted soft tissue fiducial markers. Then, the real-time perspective image can be displayed as an overlay, aligned with the static image by the registration of the fiducial markers. By visually observing the consistency of the real-time movement with the static image, assisted by the detected force data, it can help confirm the correct navigation of the associated catheter or guidewire. The system described herein can also display the comparison of the input proximal mechanical translation of the catheter or guidewire with the resulting output movement of the distal tip or its lack thereof. The loss of relative motion at the distal tip can indicate shaft buckling, prolapse, kink or similar results inside or outside the body. When shaft buckling, prolapse, kink or similar results appear outside the current perspective view, such a comparison may be beneficial.

[0197] Fig.17 A schematic side elevation view of a multi-catheter interventional device assembly 2900 for combined supra-aortic access and / or neurovascular site access and surgery (eg, aspiration) as described herein is shown. Multi-catheter assembly 2900 may be configured for manual or robotic surgery.

[0198] The interventional device assembly 2900 includes an insertion or access catheter 2902, a surgical catheter 2904, and a guide catheter 2906. Other components may include, but are not limited to, one or more guidewires (e.g., optional guidewire 2907), one or more guidewire catheters, an access sheath, and / or one or more other surgical catheters and / or associated catheter (control) hubs. In some embodiments, the assembly 2900 may also be configured with an optional deflection control 2908 for controlling the deflection of one or more catheters of the assembly 2900.

[0199] In operation, the multi-catheter assembly 2900 can be used without having to replace the hub assembly. For example, in the two-stage procedure previously disclosed, the first stage for achieving supra-aortic access includes installing the access catheter, the guide catheter, and the guidewire onto the support table. When the supra-aortic access is achieved, the access catheter and the guidewire are typically removed from the guide catheter. Then, after attaching the new guidewire hub and the surgical catheter hub to the corresponding drive pulleys on the support table, the second catheter assembly is introduced through the guidewire catheter.

[0200] Fig.17 Single multi-catheter assembly 2900 is configured to operate without having to remove hub and catheter and without adding extra assembly and / or hub.Therefore, the multi-assembly entry and surgical configuration of assembly 2900 can utilize the guidewire 2907 that is manufactured to be used as entry guidewire and navigation guidewire, to allow enough entry and support, and navigate to specific distal treatment site.In the non-limiting example that is configured to be used for robot embodiment, catheter assembly can include guidewire hub (for example, guidewire hub 2909 or guidewire hub 26 that is positioned on the drive platform and positioned at catheter 2902 right side), insert or enter catheter hub 2910, surgical catheter hub 2912, guide catheter hub 2914 and corresponding catheter.In certain embodiments, one or more hubs can include hemostatic valve (for example, rotary hemostatic valve) or be connected thereto, to adapt to the introduction of interventional device through therein. Additional details regarding hemostatic valves are included in U.S. patent application serial number 17 / 879,614, filed on August 2, 2022, entitled “Multi Catheter System With Integrated Fluidics Management,” which is hereby incorporated by reference in its entirety.

[0201] Once access above the aortic arch is complete, the insertion or access catheter 2902 (associated with the insertion catheter hub 2910) can be parked near the carotid ostium and the remainder or subset of the catheter assembly can be directed more distally to a specific site (e.g., a clot site, a surgical site, a procedure site, etc.).

[0202] In some embodiments, other smaller surgical catheters may also be added and used at the site. As used in the catheter assembly 2900 herein, in the robotic configuration of the assembly 2900, the catheter 2906 may be used as a guide catheter. The catheter 2904 may be used as a surgical (e.g., suction) catheter. In some embodiments, instead of or in addition to the catheter 2904, the catheter 2906 may also function as a suction catheter in addition to functioning as a guide catheter. The entry catheter 2902 may have a distal deflection region and may be used to enter a desired port. Those skilled in the art will appreciate FIG. 18A to FIG. 18E It is understood that manual or robotic manipulation of multiple catheter stacks is contemplated herein.

[0203] In some embodiments, catheter assembly 2900 (or other combined catheter assembly described herein) can be driven to a certain position as an assembly. However, each catheter (or guidewire) assembly can be operated and driven to the same or different positions independently of each other.

[0204] In a non-limiting example, the catheter assembly 2900 can be used for a diagnostic angiography procedure. In some embodiments, the assembly 2900 can include only a guidewire 2907 and an access catheter 2902 (in the form of a diagnostic angiography catheter) for performing a diagnostic angiography procedure, or only a guidewire 2907 and an access catheter 2902 can be used during the procedure. Optionally, the guide catheter 2906 and the surgical catheter 2904 can be retracted proximally to expose the distal end of the access catheter 2902 (e.g., a few centimeters of the distal end of the access catheter) to perform a diagnostic angiography procedure.

[0205] like Fig.17 As shown, guide catheter 2906, surgical catheter 2904, entry catheter 2902 and guide wire 2907 can be arranged concentrically. In certain embodiments, guide catheter 2906 can be a "large-caliber" guide catheter or entry catheter with a diameter of at least about 0.075 inches or at least about 0.080 inches. Surgical catheter 2904 can be an aspiration catheter with a diameter of about 0.060 inches to about 0.075 inches. Entry catheter 2902 can be a steerable catheter with a deflectable distal tip having a diameter of about 0.025 inches to about 0.050 inches. Guide wire 2907 can have a diameter of about 0.014 inches to about 0.020 inches. In one example, guide catheter 2906 may have a diameter of approximately 0.088 inches, surgical catheter 2904 may have a diameter of approximately 0.071 inches, access catheter 2902 may have a diameter of approximately 0.035 inches, and guidewire 2907 may have a diameter of approximately 0.018 inches.

[0206] FIG. 18A to FIG. 18EDepicted is an exemplary sequence of steps for introducing a multi-catheter assembly configured to manually or robotically achieve access directly to a clot. 18A to 18E Can be used Fig.17 Other combinations of catheters may be substituted for the interventional device assembly, as will be appreciated by those skilled in the art in light of the disclosure herein.

[0207] refer to Fig.18A , the three-catheter interventional device assembly 2900 is shown as being driven through the introducer sheath 3002, up through the iliac arteries 3004 and into the descending aorta. Next, the access catheter 2902, the surgical catheter 2904 (e.g., 0.071 inches) and the guide catheter 2906 (e.g., 0.088 inches) are tracked to the aortic arch 3006, as shown. Fig.18B Here, the distal end of the guide catheter 2906 can be parked below the aortic arch 3006, and the surgical catheter 2904, the access catheter 2902 (located within the surgical catheter 2904, and Fig.18B The surgical catheter 2904 and the guidewire 2907 can be driven into the ostium (e.g., simultaneously or separately). In some embodiments, the access catheter 2902 is pushed out of the surgical catheter 2904 and the guide catheter 2906 to first engage the ostium. After the distal end of the access catheter 2902 is positioned within the desired ostium, the guidewire 2907 can be advanced distally into the ostium to secure access. After the access catheter 2902 and the guidewire 2907 are located within the desired ostium, the surgical catheter 2904 and / or the guidewire 2906 can be advanced into the ostium (and in some embodiments, beyond the ostium) while using the support of the access catheter 2902 and / or the guidewire 2907 to maneuver through the aorta and into the ostium. Fig.18B In the illustrated embodiment, the surgical catheter 2904 has been advanced into the mouth, while the guide catheter 2906 has been maintained below the aortic arch 3006.

[0208] refer to Fig.18C , the guidewire 2907 can be advanced distally, and the radiopacity of the guidewire 2907 can be used to confirm under fluoroscopic imaging that access through the desired ostium has been achieved. The guidewire 2907 engages the origin of the brachiocephalic artery 3014. The guidewire 2907 is then advanced upward to the petrous segment 3018 of the internal carotid artery 3016.

[0209] refer to Fig.18D , guide catheter 2906 and surgical catheter 2904 (located within guide catheter 2906 and Fig.18D 2904 and inserted into or into the catheter 2902 (located within the surgical catheter 2904 and Fig.18DThe guidewire 2907 can be further advanced through the rock segment 3018 to the site of the clot 3020, such as the M1 segment.

[0210] refer to Fig.18E , guide catheter 2906 and surgical catheter 2904 (located within guide catheter 2906 and Fig.18E 3020) are advanced (e.g., simultaneously or sequentially) to position the distal tip of surgical catheter 2904 at the surgical site, such as on the surface of clot 3020. Guidewire 2907 and access catheter 2902 (located within surgical catheter 2904 and Fig.18E 2906) and aspiration of clot 3020 begins through surgical catheter 2904. That is, guidewire 2907 and access catheter 2902 are retracted proximally to allow aspiration through surgical catheter 2904. After aspiration of the clot, surgical catheter 2904 and guide catheter 2906 can be removed (e.g., simultaneously or sequentially). For example, in some embodiments, surgical catheter 2904 can be removed before guide catheter 2906 is removed.

[0211] The catheter assembly 2900 can be used to perform neurovascular surgery, such as FIG. 18A to FIG. 18E As shown. For example, the neurovascular procedure can be a neurovascular thrombectomy. The steps of the procedure can include providing an assembly, the assembly comprising at least a guidewire, an access catheter, a guide catheter, and a surgical 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 surgical catheter 2904. The surgical catheter 2904 can include an aspiration catheter, an embolization deployment catheter, a stent deployment catheter, a shunt deployment catheter, a diagnostic angiography catheter, a stent retrieval catheter, a clot retrieval catheter, a balloon catheter, a catheter for facilitating percutaneous valve repair or replacement, an ablation catheter, and / or an RF ablation catheter or guidewire.

[0212] The neurovascular procedure may also include the steps of connecting the components to a non-robotic or robotic drive system, and driving the components to achieve supra-aortic access. The steps may also include driving a subset of the components to the neurovascular site, and performing the neurovascular procedure using the subset of the components. The subset of components may include a guidewire, a guide catheter, and a surgical catheter.

[0213] Each of the guidewire 2907, the access catheter 2902, the guide catheter 2906, and the surgical catheter 2904 is configured to be adjusted by a corresponding hub. For example, the guidewire 2907 may include (or be connected to) a hub mounted on one of the tray assemblies described herein. Similarly, the access catheter 2902 may be connected to a catheter hub 2910. The guide catheter 2906 may be connected to a guide catheter hub 2914. The surgical catheter 2904 may be connected to a surgical catheter hub 2912.

[0214] Typically, the connection of the components can include magnetically connecting the first hub 2909 on the guidewire 2907 to the first drive magnet, magnetically connecting the second hub 2910 on the access catheter 2902 to the second drive magnet, magnetically connecting the third hub 2912 on the surgical catheter 2904 to the third drive magnet, and magnetically connecting the fourth hub 2914 on the guide catheter 2906 to the fourth drive magnet. Typically, the first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet are each independently and movably carried by the drive station, as described by the tray assembly and control member described herein. In some embodiments, the first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet are connected (e.g., connected to their corresponding catheter hubs) through a sterile barrier (e.g., a sterile and fluid barrier) and are independently and movably carried by a drive station having a plurality of driven magnets. In some embodiments, two or more drive magnets may be bolted or otherwise connected together to move as an assembly in response to commands from a single controller bolted to or otherwise connected to one of the drive magnets.

[0215] In some embodiments, the step of performing a neurovascular procedure can include driving the assembly in response to movement of each of the hub adapters along the support table until the assembly is positioned to achieve supra-aortic vascular access. The hub adapter can include, for example, a connector / pulley that acts as a shuttle by being propelled proximally or distally along a track in response to operator commands. The hub adapters described herein can each include at least one drive magnet configured to connect to a driven magnet carried by a corresponding hub. This provides a magnetic connection between the drive magnet and the driven magnet through the sterile barrier so that the corresponding hub moves into the top of the sterile barrier (such as a sterile barrier) in response to movement of the hub adapter outside the sterile field. Figure 4 ). Movement of the hub adapter is driven by a drive system carried by a support platform on which the guidewire hub 2909, guide catheter hub 2914, surgical catheter hub 2912 and access catheter hub 2910 are mounted.

[0216] The steps may also include driving a subset of the components in response to movement of each of the hub adapters along the support table until the subset of components is positioned to perform a neurovascular procedure at a neurovascular treatment site. The subset of components may include a guidewire 2907, a guide catheter 2906, and a surgical catheter 2904.

[0217] In some embodiments, the guidewire 2907, guide catheter 2906, and surgical catheter 2904 are passed as an assembly (relative to the guidewire 2907) and over (relative to the guide catheter 2906 and surgical catheter 2904) at least a portion of the length of the entry (e.g., insertion) catheter 2902 after access over the aorta is achieved.

[0218] In some embodiments, catheter assembly 2900 can be part of a robotically controlled system for achieving supra-aortic access and neurovascular treatment site access, such as FIG. 18A to FIG. 18E As shown. In some embodiments, catheter assembly 2900 can be part of a manual control system for achieving supra-aortic access and neurovascular treatment site access. In some embodiments, catheter assembly 2900 can be part of a hybrid control system (having manual and robotic components) for achieving supra-aortic access and neurovascular treatment site access. For example, in such a hybrid system, supra-aortic access can be robotically driven, while neurovascular site access and embolectomy or other surgeries can be manual. Alternatively, in such a hybrid system, supra-aortic access can be manual, while neurovascular site access can be robotically achieved. In addition, in such a hybrid system, any one or more of the guidewire, access catheter, guide catheter, or surgical catheter can be robotically driven or manually operated.

[0219] The example robotic control system may include at least a guidewire hub (e.g., guidewire hub 2909) configured to adjust each of the axial position and the rotational position of the guidewire 2907. The robotic control system may also include an access catheter hub 2910 configured to adjust the axial and rotational movement of the access catheter 2902. The robotic control system may also include a guide catheter hub 2914 configured to control the axial movement of the guide catheter 2906. The robotic control system may also include a surgical catheter hub 2912 configured to adjust the axial position and the rotational position of the surgical catheter 2904.

[0220] In some embodiments, the surgical catheter hub 2912 is also configured to laterally deflect the distal deflection region of the surgical catheter 2904 .

[0221] In some embodiments, the guidewire hub 2909 is configured to be connected to the guidewire hub adapter by magnetically connecting the guidewire hub to the first drive magnet. The access catheter hub 2910 is configured to be connected to the access catheter hub adapter by magnetically connecting the access catheter hub 2910 to the second drive magnet. The surgical catheter hub 2912 is configured to be connected to the surgical catheter hub adapter by magnetically connecting the surgical catheter hub 2912 to the third drive magnet. The guide catheter hub 2914 is configured to be connected to the guide catheter hub adapter by magnetically connecting the guide catheter hub 2914 to the fourth drive magnet. In some embodiments, the first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet are independently and movably carried by the drive platform.

[0222] In some embodiments, the robotic control system includes a first driven magnet on the guidewire hub 2909. The first driven magnet can be configured to cooperate with the first drive magnet such that the first driven magnet is configured to move in response to movement of the first drive magnet. In some embodiments, the first drive magnet is configured to move through a barrier to the outside of the sterile area separated from the first driven magnet when the first driven magnet is within the sterile area. In some embodiments, the position of the first driven magnet can move in response to operation of a surgical drive control on a console associated with the drive station. Reference above Figure 4 The interaction of the driving and driven magnets is described in detail.

[0223] In some embodiments, the robotic control system includes a second driven magnet on the entry catheter hub 2910. The second driven magnet can be configured to cooperate with the second drive magnet so that the second driven magnet is configured to move in response to the movement of the second drive magnet. In some embodiments, the second drive magnet is configured to move through a barrier to the outside of the sterile area separated from the second driven magnet when the second driven magnet is within the sterile area.

[0224] In some embodiments, the robotic control system includes a third driven magnet on the surgical catheter hub 2912. The third driven magnet can be configured to cooperate with the third drive magnet so that the third driven magnet is configured to move in response to the movement of the third drive magnet. In some embodiments, the third drive magnet is configured to move through a barrier to the outside of the sterile area separated from the third driven magnet when the third driven magnet is within the sterile area.

[0225] In some embodiments, the robotic control system includes a fourth driven magnet on the guide catheter hub 2914. The fourth driven magnet can be configured to cooperate with the fourth drive magnet so that the fourth driven magnet is configured to move in response to the movement of the fourth drive magnet. In some embodiments, the fourth drive magnet is configured to move to the outside of the sterile area separated from the fourth driven magnet through a barrier when the fourth driven magnet is within the sterile area. In some embodiments, there can be more than four driven magnets and corresponding catheter hubs for controlling additional catheters.

[0226] In some embodiments, the devices described herein (e.g., hubs, hub adapters, interventional devices, and / or trays) can be used in robotically driven surgery. For example, in a robotically driven surgery, one or more interventional devices can be driven through the vascular system and reach the surgical site. Robotically driving such a device can include engaging an electromechanical assembly controlled by user input. In some embodiments, a user can provide input at a control system that interfaces with one or more hubs and hub adapters.

[0227] In some embodiments, the hubs, hub adapters, interventional devices, and trays described herein can be used during non-robotic (eg, manually driven) surgery. Manually driving such a device can include manually engaging the hub to affect movement of the interventional device.

[0228] In some embodiments, the devices described herein can be used to implement methods for performing intracranial surgery at an intracranial location. The methods for performing intracranial surgery can include any of the same steps as those described herein for performing neurovascular surgery. The methods can be performed robotically, manually, or a combination of both.

[0229] Although the foregoing describes a magnetic connection of a hub to a drive magnet, in other embodiments, any interventional device and / or hub may be mechanically connected to a drive system. Any method described herein may include the step of mechanically connecting one or more interventional devices (e.g., guidewire 2907, access catheter 2902, surgical catheter 2904, and / or guide catheter 2906) and / or one or more hubs (e.g., guidewire hub 2909, access catheter hub 2910, surgical catheter hub 2912, and / or guide catheter hub 2914) to one or more drive mechanisms.

[0230] Fig.19A mechanical connection mechanism 1654 between the drive mechanism 1650 and the driven mechanism 1652 is shown. The drive mechanism 1650 and the driven mechanism 1652 can have any features or functions that are the same or similar to the drive magnet 67 and the driven magnet 69, respectively, unless otherwise described herein. The drive mechanism 1650 can be part of or connected to a hub adapter (e.g., hub adapter 48). The driven mechanism 1652 can be part of or connected to a hub (e.g., hub 36, guidewire hub 2909, access catheter hub 2910, surgical catheter hub 2912, or guide catheter hub 2914). In some cases, the mechanical connection mechanism 1654 can include a structural support member (e.g., a support rod or support strut) that extends laterally through the seal in the sterile barrier 1632. When the drive mechanism 1650 and the driven mechanism 1652 are advanced and / or retracted as described herein, the seal can allow the structural support to be advanced along the length of the sterile barrier 1632 while still maintaining a seal with the structural support to maintain the sterile field. For example, the seal can include a tongue and groove closure mechanism along the sterile barrier 1632 that is configured to close on either side of the structural support while allowing the structural support to pass through the sterile barrier 1632 and maintaining the seal against the structural support as the structural support is advanced along the length of the sterile barrier 1632.

[0231] In some embodiments, the structural support can extend through an elongated self-closing seal (e.g., shaped like a duckbill valve) between two adjacent mating edges of a flexible material that extends along the shaft. As the structural support is advanced along the shaft between the mating edges, the mating edges can allow the structural support to be advanced and then biased back into sealing engagement with each other as the structural support passes any given point along the shaft.

[0232] In some embodiments, the drive mechanism can be a spline drive shaft (e.g., a non-sterile spline drive shaft). Mechanical connection 1654 can include a pulley in a plate used as a sterile barrier 1632 and a sterile spline shaft configured to be connected to a driven mechanism 1652. Driven mechanism 1652 can be a sterile pulley that receives a sterile spline shaft from a sterile barrier. In some embodiments, one or more spline drive shafts can engage and rotate the corresponding pulleys used as sterile barriers in the plate. Each hub can have a sterile pulley that is configured to receive a sterile spline shaft from a sterile barrier plate. The rotation of the spline drive shaft can rotate the pulley in the sterile barrier plate, and the sterile barrier plate can rotate the sterile pulley in the hub via a sterile spline shaft.

[0233] Those skilled in the art will appreciate that any of the embodiments described herein may be modified to incorporate mechanical attachment mechanisms, such as Fig.19 shown.

[0234] The interventional devices described herein may be provided individually, or at least some of the interventional devices may be provided in a preassembled (e.g., nested or stacked) configuration. For example, the interventional devices may be provided in a concentric nested or stacked configuration in the form of an interventional device assembly (e.g., interventional device assembly 2900). If provided individually, each catheter (and in some embodiments, each corresponding catheter hub) may be unpacked and prefilled to remove air from its inner lumen, for example, by flushing the catheter (and in some embodiments, flushing the corresponding catheter hub) to remove air by replacing the air with a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent). After prefilling, the interventional devices may be manually assembled into a stacked configuration so that they are ready to be introduced into the body for surgical procedures, for example, via an introducer sheath.

[0235] Assembling the devices into a stacked configuration can include inserting the interventional devices individually into each other in order of size. For example, an interventional device having the second largest diameter can be inserted into the lumen of an interventional device having the largest diameter. An interventional device having the third largest diameter can then be inserted into an interventional device having the second largest diameter, and so on.

[0236] For example, by Fig.17 , can be assembled by first inserting the distal end of catheter 2904 through hub 2914 and into catheter 2906. Catheter 2904 can be advanced through catheter 2906 until the distal tip of catheter 2904 is flush with or extends beyond the distal tip of catheter 2906, and / or until catheter 2904 can no longer be inserted. Then, the distal end of catheter 2902 can be inserted through hub 2912 and into catheter 2904. Catheter 2902 can be advanced through catheter 2904 until the distal tip of catheter 2902 is flush with or extends beyond the distal tip of catheter 2904, and / or until catheter 2902 can no longer be inserted. Then, the distal end of guidewire 2907 can be inserted through hub 2910 and into catheter 2902. The guidewire 2907 may be advanced through the catheter 2902 until the distal tip of the guidewire 2907 is flush with or extends beyond the distal tip of the catheter 2902 and / or until the guidewire 2907 cannot be inserted any further.

[0237] Embodiments in which two or more interventional devices are packaged together as a single assembly in an assembled (e.g., nested or stacked) configuration can provide effective unpacking and preparation before use, and provide effective assembly within a robotic control system. The interventional devices can be pre-installed to their corresponding hubs before packaging. In certain embodiments, two or three or more interventional devices can be packaged in a fully nested (i.e., fully axially inserted) configuration or an almost fully nested configuration. In a fully nested configuration, each interventional device is inserted as far as possible into adjacent distal hubs and interventional devices. 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.

[0238] In some embodiments, the interventional device can also be sterilized prior to packaging while in the assembled configuration, e.g., using ethylene oxide gas. In some embodiments, the interventional device can be packaged 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., an annular lumen between the outer diameter of a first interventional device nested within a second interventional device and the inner diameter of a second interventional device) for sterilization. In some embodiments, the interventional device components can be packaged in a thermoformed tray and wrapped with HDPE (e.g., ) cover seal. The interventional device assembly can be unpacked by removing (e.g., opening or peeling off) the cover by a user in a non-sterile area. The user in the sterile area can then remove the interventional device assembly and place it on a sterile work surface, such as a robotic drive table, as described herein.

[0239] Packaging the interventional device in an assembled configuration and sterilized state can reduce the time associated with unpacking and assembly of individual interventional devices and facilitate efficient connection to a robotic drive system. Each interventional device and hub combination can also be packaged with a fluidic connector for connecting to a fluid source and / or a vacuum source. In some embodiments, each hub or hemostatic valve connected to the hub can include a fluidic connector.

[0240] After unpacking the interventional device assembly (e.g., after positioning the interventional device assembly on the robotic drive station), priming can be performed while the devices are concentrically nested or stacked. This is preferably done in each fluid lumen, e.g., the annular lumen between catheter 2906 and catheter 2904, and between each additional concentric interventional device in the concentric stack. In some embodiments, the fluid lumen may include a lumen between the distal hub and the proximal interventional device, e.g., the lumen between hub 2914 and catheter 2904. In some embodiments, priming can be performed while the device is still in sterile packaging.

[0241] Fluidics connector can be connected to fluidics system, for saline and contrast agent are delivered to conduit and suction is provided.In some embodiments, fluidics connector can be delivered to the outside of sterile area, for being connected to fluidics system.After connection, fluidics system can carry out a series of pre-filling to rinse each conduit of interventional device assembly with fluid (for example, saline, contrast agent, or the mixture of saline and contrast agent).A series of pre-filling can also include flushing each corresponding conduit hub with fluid.Fluid can be deaerated or degassed by fluidics system before pre-filling.In some embodiments, the vacuum source of fluidics system can also be used for evacuating air from each conduit while flushing with fluid.In certain embodiments, the tip of conduit can be placed in the container of fluid (for example saline, contrast agent, or the mixture of saline and contrast agent) during pre-filling, so that when applying vacuum source, the fluid in the container instead of air is sucked by the tip of conduit.In other embodiments, the tip of conduit can be closed (for example, using stopper), so that when applying vacuum source, air can not be sucked from the tip of conduit. In certain embodiments, the priming process can be automated such that a user can provide a single command, and each catheter (and in some embodiments, each corresponding catheter hub) can be primed sequentially or simultaneously (e.g., as by FIG. 20A to FIG. 20C described).

[0242] Additional details regarding the fluidics system are described in U.S. patent application serial number 17 / 879,614, filed on August 2, 2022, entitled “MultiCatheter System With Integrated Fluidics Management,” which is hereby expressly incorporated herein in its entirety.

[0243] When the cross-sectional lumen area available for flow is reduced, for example, when a second interventional device (e.g., a catheter or guidewire) is extended within the lumen of a first interventional device, the fluid resistance within the lumen can be greater. For example, the amount of fluid resistance can be affected by the length narrowing of the cross section due to the depth of axial insertion of the second interventional device within the first interventional device. A second interventional device that extends partially through the lumen of the first interventional device will provide a smaller length narrowing of the cross section, and therefore may result in a lower fluid resistance within the lumen of the first catheter than if the second interventional device extends completely through the lumen of the first interventional device. Therefore, fluid resistance can be reduced by at least partially reducing the depth of axial insertion (i.e., axial overlap) of the second interventional device into a lumen, which is a lumen through which fluid is injected (e.g., the length of the second interventional device into its concentrically adjacent lumen).

[0244] In some embodiments, at certain insertion depths of the second interventional device within the first interventional device (e.g., when the second interventional device is at or near a maximum insertion depth within the first interventional device), the size of the fluid pathway between the devices (e.g., an annular lumen between the first interventional device and the second interventional device) can result in a higher than desired amount of fluid resistance during the priming process. In some embodiments, the insertion depth of the second interventional device within the first interventional device can be reduced to reduce the pressure required to prime the catheter and reduce internal interference.

[0245] In some embodiments, the catheter in the interventional device assembly can be separated from other interventional devices for prefilling, to reduce the pressure required for prefilling catheter and reduce internal interference. By making the interventional device retract to the proximal end in the lumen of catheter, the catheter to be prefilled can be separated from the interventional device in the lumen of catheter. For example, the interventional device in the lumen of the catheter to be prefilled can be retracted to the proximal end as far as possible from the catheter to be prefilled, while still maintaining a nested or stacked relationship (for example, at least about 2cm or 5cm or more axial overlap), so as to minimize the pressure required for prefilling catheter and minimize internal interference. In other words, the catheter can be separated from the more proximal interventional device for prefilling, while the distal tip of the adjacent proximal interventional device is still located in the lumen of catheter. At least some distal tips of the adjacent proximal interventional devices are maintained in the lumen of catheter can allow to more easily reinsert and advance the proximal interventional device after prefilling.

[0246] In some embodiments, the axial overlap can be from about 2 cm to about 20 cm, from about 2 cm to 10 cm, from about 2 cm to 5 cm, from about 5 cm to 20 cm, from about 5 cm to 10 cm, or any other suitable range. In some embodiments, the axial overlap can be at least about 2 cm, at least about 5 cm, at least about 10 cm, at least about 20 cm, no more than 2 cm, no more than 5 cm, no more than 10 cm, no more than 20 cm, about 2 cm, about 5 cm, about 10 cm, about 20 cm, or any other suitable amount.

[0247] In some embodiments, the robotically driven stage can be programmed to retract the internal interventional device proximally from the catheter to be prefilled as much as possible while still maintaining a nested or stacked relationship. In other embodiments, the robotically driven stage can be programmed to separate the internal device from the catheter to be prefilled to a distance sufficient to optimize the length of the unobstructed lumen and result in an amount of fluid resistance below a threshold. After the catheter to be prefilled is separated from the other interventional devices, the catheter can be prefilled by flushing the catheter with a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent).

[0248] After the catheter is pre-filled, it can be returned to the initial position and the next catheter of the interventional device assembly can be separated from the other interventional devices within its lumen for pre-filling. This sequence can be repeated for each catheter of the interventional device assembly. In other embodiments, after the catheter is pre-filled, it can be advanced to a ready or drive position to begin insertion into the patient. Although the foregoing describes the separation of the catheter to be pre-filled by retracting the inner interventional device, the outer catheter can also be separated from the inner interventional device by axially advancing the outer catheter distally relative to the inner interventional device. FIG. 20A to FIG. 20C , an example of the precharging process is described.

[0249] Fig. 20A An interventional device assembly 2900 is depicted assembled in a concentrically stacked and axially compressed configuration. Fig. 20A As shown, the interventional devices can be completely nested within each other. This can be the configuration after the device assembly 2900 is unpacked and placed on the robotic drive table. A series of priming can be initiated by axially advancing the catheter 2906 and hub 2914 distally relative to the catheter 2904, hub 2912, catheter 2902, hub 2910, guidewire 2907 and hub 2909, for example, as far as possible while maintaining the distal tip of the catheter 2904 within the lumen of the catheter 2906, as shown. Fig. 20B As shown, or advanced 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 a fluidics system. In some embodiments, the priming fluid is introduced in response to a control signal from a control system. The priming catheter 2906 may include a priming hub 2914. For example, in certain embodiments, the hub 2914 or a hemostatic valve connected thereto may include a fluidics connector to receive the priming fluid from the fluidics system. After priming, catheter 2906 can be returned to its initial position (e.g., a fully axially compressed configuration), as shown. Fig. 20A In some embodiments, the catheter 2906 is returned to its initial position in response to a control signal from a control system.

[0250] After catheter 2906 is 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 (also axially advancing catheter 2906 and hub 2914 distally without changing or minimally changing their relative positions relative to catheter 2904), for example, as far as possible while maintaining the distal tip of catheter 2902 within the lumen of catheter 2904, as shown. Fig. 20Cas shown, or advanced to a distance that will result in a desired amount of fluid resistance for priming. In some embodiments, catheter 2904 and catheter 2906 are advanced in response to a control signal from a control system. Catheter 2904 can then be priming by introducing a priming fluid using a fluidics system. In some embodiments, the priming fluid is introduced in response to a control signal from a control system. Prefill catheter 2904 may include a priming hub 2912. For example, in certain embodiments, hub 2912 or a hemostatic valve connected thereto may include a fluidics connector to receive priming fluid from a fluidics system. After priming, catheter 2904 and catheter 2906 may be returned to their initial positions (e.g., a fully axially compressed configuration), as shown. Fig. 20A In some embodiments, conduit 2904 and conduit 2906 are returned to their initial positions in response to a control signal from a control system.

[0251] After the catheter 2904 is primed and returned to its initial position, the catheter 2902 and hub 2910 can be axially advanced distally relative to the guidewire 2907 and hub 2909 (also axially advancing the catheter 2906, hub 2914, catheter 2904 and hub 2912 distally without changing or minimally changing their relative positions relative to the catheter 2902), for example, as far as possible while keeping the distal tip of the guidewire 2907 within the lumen of the catheter 2902, or to a distance that will result in a desired amount of fluid resistance for priming. In some embodiments, the catheter 2902, catheter 2904 and catheter 2906 are advanced in response to a control signal from a control system. The catheter 2902 can then be primed by introducing a priming fluid using a fluidics system. In some embodiments, the priming fluid is introduced in response to a control signal from a control system. The priming catheter 2902 may include a priming hub 2910. For example, in some embodiments, hub 2910 or a hemostatic valve connected thereto may include a fluidic connector to receive a priming fluid from a fluidic system. After priming, catheter 2902 and catheters 2904 and 2906 may be returned to Fig. 20A Their initial positions are shown (eg, fully axially compressed configuration). In some embodiments, catheter 2902, catheter 2904, and catheter 2906 are returned to their initial positions in response to a control signal from a control system.

[0252] In some embodiments, by FIG. 20A to FIG. 20C The described priming procedure may be performed in response to a single control signal from a control system. In other embodiments, the various steps of the priming procedure may be performed in response to unique control signals. In some embodiments, the priming of each unique interventional device may be performed in response to a unique control signal.

[0253] In an alternative embodiment, each of the catheters can be separated distally from each other simultaneously for priming. For example, catheter 2902 can be separated distally from guidewire 2907 while maintaining the distal tip of guidewire 2907 within the lumen of catheter 2902, catheter 2904 can be separated distally from catheter 2902 while maintaining the distal tip of catheter 2902 within the lumen of catheter 2904, and catheter 2906 can be separated distally from catheter 2904 while maintaining the distal tip of catheter 2904 within the lumen of catheter 2906. However, as described above, the present invention provides a method for priming catheters. FIG. 20A to FIG. 20C In the described embodiments, only one set of adjacent hubs are separated at a time, which can provide a smaller overall assembly length at any particular time, which can allow for use with a smaller robotic drive system. Although separation of the outer catheters from their inner interventional devices is described as axially advancing the catheters distally relative to their inner interventional devices, separation can include retracting the inner interventional devices proximally from the outer catheters.

[0254] In an alternative embodiment, one or more of catheters 2902, 2904, and 2906 can be advanced to a ready or actuated position to begin insertion into a patient after priming (e.g., before priming a subsequent catheter). In such an embodiment, the catheters can be advanced to the ready or actuated positions without returning to their initial positions after priming.

[0255] As described above, in some embodiments, catheters 2902, 2904, and 2906 can be assembled prior to flushing the catheter. Fig.17 The concentric stack shown is oriented to remove air by displacing the air with a fluid (e.g., saline contrast or a mixture of saline and contrast). This is preferably done in each fluid lumen, e.g., the annular lumen between catheter 2906 and catheter 2904, and between each of the additional concentric interventional devices in the concentric stack. Infusing fluid (e.g., saline, contrast, or a mixture of saline and contrast) under pressure can displace substantially all of the air, but may retain some small bubbles that adhere to the inner wall of the outer catheter (e.g., guide catheter 2906), the outer wall of the inner catheter (e.g., surgical catheter 2904), or both.

[0256] When fluid is introduced into the proximal end of the annular lumen under pressure (for example, introduced into the hub of the outer catheter or the hemostatic valve connected thereto), the inner catheter can move relative to the outer catheter to destroy the holding force between microbubbles and adjacent walls, and allow the bubble to be brought downstream and discharged or removed via suction through the distal opening of the cavity. The catheter can move axially, rotationally or axially and rotationally relative to each other. In certain embodiments, the catheter can reciprocate axially, rotationally or axially and rotationally relative to each other. In some embodiments, the catheter can reciprocate, axially, rotationally or reciprocatingly axially and rotationally. In other embodiments, the catheter can rotate continuously or rotate in a constant direction.

[0257] In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, axially reciprocating over a stroke length of about 1 mm to about 250 mm, about 10 mm to about 250 mm, about 5 mm to about 125 mm, about 25 mm to about 125 mm, about 10 mm to about 50 mm, about 15 mm to about 30 mm, about 5 mm to about 30 mm, about 15 mm to about 25 mm, about 20 mm to about 40 mm, or any other suitable range. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, axially reciprocating over a stroke length of at least 5 mm, at least 10 mm, at least 15 mm, at least 20 mm, at least 25 mm, at least 30 mm, at least 50 mm, no more than 10 mm, no more than 20 mm, no more than 25 mm, no more than 30 mm, no more than 50 mm, no more than 125 mm, no more than 150 mm, about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 50 mm, or any other suitable stroke length.

[0258] In some embodiments, the first conduit reciprocates relative to an adjacent conduit or guidewire, for example, axially reciprocates with a reciprocating frequency of about 0.5 Hz to about 1 Hz, about 1 Hz to about 5 Hz, about 1 Hz to about 10 Hz, about 1 Hz to about 25 Hz, about 5 Hz to about 10 Hz, about 10 Hz to about 25 Hz, or any other suitable frequency range. In some embodiments, the first conduit reciprocates relative to an adjacent conduit or guidewire, for example, axially reciprocates with a reciprocating frequency of at least 0.5 Hz, at least 1 Hz, at least 2 Hz, at least 5 Hz, at least 10 Hz, at least 25 Hz, no more than 0.5 Hz, no more than 1 Hz, no more than 2 Hz, no more than 5 Hz, no more than 10 Hz, no more than 25 Hz, about 0.5 Hz, about 1 Hz, about 2 Hz, about 5 Hz, about 10 Hz, about 25 Hz, or any other suitable frequency.

[0259] In one embodiment, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example axially reciprocating over a stroke length of about 0.5 inches to about 10 inches, or axially reciprocating over a stroke length of about 1 inch to about 5 inches at a reciprocating frequency of no more than about 5 cycles / second or two cycles / second or less.

[0260] In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, at about 5 degrees to about 180 degrees, about 5 degrees to about 360 degrees, about 15 degrees to about 180 degrees, about 15 degrees to about 150 degrees, about 15 degrees to about 120 degrees, about 15 degrees to about 90 degrees, about 15 degrees to about 60 degrees, about 15 degrees to about 30 degrees, about 30 degrees to about 180 degrees, about 30 degrees to about 150 degrees, about 30 degrees to about 120 degrees, about 30 degrees to about 90 degrees, about 15 degrees to about 60 degrees, about 15 degrees to about 30 degrees, about 30 degrees to about 180 degrees, about 30 degrees to about 150 degrees, about 30 degrees to about 120 degrees, about 30 degrees to about 150 degrees. Rotatably reciprocatingly about an angle of rotation / stroke of about 90 degrees, about 30 degrees to about 60 degrees, about 60 degrees to about 180 degrees, about 60 degrees to about 150 degrees, about 60 degrees to about 120 degrees, about 60 degrees to about 90 degrees, about 90 degrees to about 180 degrees, about 90 degrees to about 150 degrees, about 90 degrees to about 120 degrees, about 120 degrees to about 180 degrees, about 120 degrees to about 150 degrees, about 150 degrees to about 180 degrees, or any other suitable range of rotation angle / stroke. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, rotationally reciprocating with a rotation angle / stroke of at least 5 degrees, at least 15 degrees, at least 30 degrees, at least 60 degrees, at least 90 degrees, at least 120 degrees, at least 150 degrees, at least 180 degrees, at least 360 degrees, no more than 5 degrees, no more than 15 degrees, no more than 30 degrees, no more than 60 degrees, no more than 90 degrees, no more than 120 degrees, no more than 150 degrees, no more than 180 degrees, no more than 360 degrees, about 5 degrees, about 15 degrees, about 30 degrees, about 60 degrees, about 90 degrees, about 120 degrees, about 150 degrees, about 180 degrees, about 360 degrees, or any other suitable angle.

[0261] In some embodiments, the first conduit reciprocates relative to an adjacent conduit or guidewire, for example, with a reciprocating frequency of about 0.5 Hz to about 1 Hz, about 1 Hz to about 5 Hz, about 1 Hz to about 10 Hz, about 1 Hz to about 25 Hz, about 5 Hz to about 10 Hz, about 10 Hz to about 25 Hz, or any other suitable frequency range. In some embodiments, the first conduit reciprocates relative to an adjacent conduit or guidewire, for example, with a reciprocating frequency of at least 0.5 Hz, at least 1 Hz, at least 2 Hz, at least 5 Hz, at least 10 Hz, at least 25 Hz, no more than 0.5 Hz, no more than 1 Hz, no more than 2 Hz, no more than 5 Hz, no more than 10 Hz, no more than 25 Hz, about 0.5 Hz, about 1 Hz, about 2 Hz, about 5 Hz, about 10 Hz, about 25 Hz, or any other suitable frequency range.

[0262] In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire for a reciprocating number of times within a suitable range of 1 to 200, 1 to 100, 1 to 50, 1 to 25, 1 to 15, 1 to 10, 1 to 5, 5 to 25, 5 to 15, 5 to 10, or any other suitable range. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire for 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, no more than 5 reciprocations, no more than 10 reciprocations, no more than 15 reciprocations, no more than 25 reciprocations, no more than 50 reciprocations, no more than 100 reciprocations, no more than 200 reciprocations, about 1 reciprocation, about 2 reciprocations, about 5 reciprocations, about 10 reciprocations, about 25 reciprocations, about 50 reciprocations, about 100 reciprocations, about 200 reciprocations, or any other suitable number of reciprocating movements. A reciprocating movement can include movement (axially or rotationally) from a first position to a second position, and then returning to the first position from the second position.

[0263] In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire over a length of time from about 1 second to about 60 seconds, from about 1 second to about 45 seconds, from about 1 second to about 30 seconds, from about 1 second to about 20 seconds, from about 1 second to about 15 seconds, from about 1 second to about 10 seconds, from about 5 seconds to about 45 seconds, from about 5 seconds to about 30 seconds, from about 5 seconds to about 20 seconds, from about 5 seconds to about 15 seconds, from about 5 seconds to about 10 seconds, from about 10 seconds to about 30 seconds, from about 10 seconds to about 20 seconds, or any other suitable range. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire for a period of at least 1 second, at least 5 seconds, at least 10 seconds, at least 15 seconds, at least 20 seconds, at least 30 seconds, at least 45 seconds, at least 60 seconds, no more than 5 seconds, no more than 10 seconds, no more than 15 seconds, no more than 20 seconds, no more than 30 seconds, no more than 45 seconds, no more than 60 seconds, about 5 seconds, about 10 seconds, about 15 seconds, about 20 seconds, about 30 seconds, about 45 seconds, about 60 seconds, or any other suitable period of time.

[0264] The reciprocating movement of adjacent catheters to destroy microbubbles can be accomplished by manually grasping the corresponding catheter hubs and manually moving the catheters axially or rotationally relative to each other while delivering a pressurized fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent). Alternatively, for example, in a robotically driven system, the processor can be configured to robotically drive at least one of two adjacent catheter hubs (e.g., at least one of hub 2914 and hub 2912) to achieve relative movement between adjacent catheters, thereby destroying and discharging microbubbles, such as in response to user activation of a flushing control. For example, in some embodiments, two adjacent interventional devices can be moved relative to each other in response to a control signal from a control system. In some embodiments, the delivery of a pressurized fluid can be performed in response to a control signal from a control system.

[0265] The reciprocating movement of adjacent conduits can generate a shear force that removes bubbles. For example, the relative movement of the inner and outer surfaces of adjacent conduits can increase the fluid shear rate between adjacent conduits during pre-filling compared to a static surface. In some embodiments, the shear force can be increased by increasing the flow rate of a solution (e.g., saline, contrast agent, or a mixture of saline and contrast agent) provided by a fluidics system. In certain embodiments, the flow rate and relative movement between adjacent conduits are controlled to remove bubbles.

[0266] In some embodiments, after each catheter is primed by the fluidics system, an ultrasonic bubble detector can be used to confirm that the catheter is substantially free of bubbles. For example, an ultrasonic chip (e.g., mounted in a hub adjacent to the catheter receiving lumen) can be extended along the length of the catheter to confirm that no bubbles remain in the system.

[0267] pass FIG. 21A to FIG. 21B An example of a priming procedure that includes reciprocating movement of adjacent catheters is described.

[0268] Fig.21A An interventional device assembly 2900 is depicted assembled into a concentric stacked configuration. Fig.21A As shown, the interventional devices can be completely nested in each other. This can be the configuration after the device assembly 2900 is unpacked and placed on the robotic drive table. Alternatively, the individual interventional devices of the device assembly 2900 can be assembled into the device assembly 2900 on the drive table.

[0269] A series of priming can be initiated by priming catheter 2906. In some embodiments, catheter 2906 can be primed by introducing a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of catheter 2906 while causing axial, rotational, or axial and rotational reciprocating movement of catheter 2906 and / or hub 2914 relative to catheter 2904. Prefilling catheter 2906 may include prefilling hub 2914. For example, in certain embodiments, hub 2914 or a hemostatic valve connected thereto may include a fluidic connector to receive a priming fluid from a fluidic system. In certain embodiments, catheter 2906 and / or hub 2914 may be moved along the longitudinal axis of catheter 2906 (e.g., at Fig.21A Location and Fig.21B The axial and / or rotational reciprocating motion of the conduit 2906 and / or hub 2914 may be performed manually or by a robotic drive stage. The reciprocating motion may be generated in response to a control signal from a control system. The introduction of the fluid under pressure may be performed in response to a control signal from a control system.

[0270] In some embodiments, priming of the catheter 2906 can be performed by introducing a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of the catheter 2906 while causing axial, rotational, or axial and rotational reciprocating movement of the catheter 2904 and / or hub 2912 relative to the catheter 2906. The axial and / or rotational reciprocating movement of the catheter 2904 and / or hub 2912 can be performed manually or by a robotic drive station. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0271] In some embodiments, priming of catheter 2906 can be performed by introducing a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of catheter 2906 while causing axial, rotational, or axial and rotational reciprocating movement of both catheter 2906 (and / or hub 2914) and catheter 2904 (and / or hub 2912) relative to each other. The reciprocating movement can be caused in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0272] In some embodiments, after priming catheter 2906, catheter 2906 can be returned to Fig.21A Initial position shown. In other embodiments, after priming catheter 2906, catheter 2906 can be advanced to a ready or driven position to begin insertion into the patient.

[0273] In some embodiments, after the catheter 2906 is pre-filled, the catheter 2904 can be pre-filled. The pre-filled catheter 2904 can include a pre-filled hub 2912. For example, in certain embodiments, the hub 2912 or a hemostatic valve connected thereto can include a fluidic connector to receive a pre-filled fluid from a fluidic system. In some embodiments, the catheter 2904 can be pre-filled by introducing a fluid (e.g., saline, a contrast agent, or a mixture of saline and a contrast agent) into the lumen of the catheter 2904 under pressure while causing the catheter 2904 and / or the hub 2912 to reciprocate axially, rotationally, or axially and rotationally relative to the catheter 2902. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0274] In some embodiments, priming of the catheter 2904 can be performed by introducing a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of the catheter 2904 while causing axial, rotational, or axial and rotational reciprocating movement of the catheter 2902 and / or hub 2910 relative to the catheter 2904. The axial and / or rotational reciprocating movement of the catheter 2902 and / or hub 2910 can be performed manually or by a robotic drive station. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0275] In some embodiments, priming of catheter 2904 can be performed by introducing a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of catheter 2904 while causing axial, rotational, or axial and rotational reciprocating movement of both catheter 2904 (and / or hub 2912) and catheter 2902 (and / or hub 2910) relative to each other. The reciprocating movement can be caused in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0276] In some embodiments, after priming catheter 2904, catheter 2904 can be returned to Fig.21A Initial position shown. In some embodiments, after priming catheter 2904, catheter 2904 can be advanced to a ready or driven position to begin insertion into the patient.

[0277] In some embodiments, after the catheter 2904 is pre-filled, the catheter 2902 can be pre-filled. The pre-filled catheter 2902 may include a pre-filled hub 2910. For example, in certain embodiments, the hub 2910 or a hemostatic valve connected thereto may include a fluidic connector to receive a pre-filled fluid from a fluidic system. In some embodiments, the catheter 2902 may be pre-filled by introducing a fluid (e.g., saline, a contrast agent, or a mixture of saline and a contrast agent) into the lumen of the catheter 2902 under pressure while generating an axial, rotational, or axial and rotational reciprocating movement of the catheter 2902 and / or the hub 2910 relative to the guidewire 2907. The reciprocating movement may be generated in response to a control signal from a control system. The introduction of the fluid under pressure may be performed in response to a control signal from a control system.

[0278] In some embodiments, the priming of the catheter 2902 can be performed by introducing a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of the catheter 2902 while causing the guidewire 2907 and / or the hub 2909 to reciprocate axially, rotationally, or axially and rotationally relative to the catheter 2902. The axial and / or rotational reciprocating movement of the guidewire 2907 and / or the hub 2909 can be performed manually or by a robotic drive station. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0279] In some embodiments, priming of the catheter 2902 can be performed by introducing a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of the catheter 2902 while causing axial, rotational, or axial and rotational reciprocating movement of both the catheter 2902 (and / or hub 2910) and the guidewire 2907 (and / or hub 2909) relative to each other. The reciprocating movement can be caused in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0280] In some embodiments, after priming catheter 2902, catheter 2902 can be returned to Fig.21A Initial position shown. In other embodiments, after priming catheter 2902, catheter 2902 can be advanced to a ready or driven position to begin insertion into the patient.

[0281] In some embodiments, by Fig.21A and Fig.21BThe described priming procedure may be performed in response to a single control signal from a control system. In other embodiments, various steps of the priming procedure may be performed in response to unique control signals. In some embodiments, priming of a unique interventional device may be performed in response to a unique control signal.

[0282] In this article through Fig.21A and Fig.21B In the series of priming described, the catheters are primed sequentially, starting with catheter 2906, followed by catheter 2904, and then catheter 2902. However, it is contemplated that the catheters may be primed in any order. The catheters may be primed as described above. Fig.21A and Fig.21B Alternatively, two or more catheters or each catheter may be primed in parallel.

[0283] In certain embodiments, the prefilling catheter may include reducing the depth of axial insertion (i.e., axial overlap) of the second interventional device into the lumen of the first interventional device through which the fluid is injected (e.g., the length of the second interventional device into its concentrically adjacent lumen), such as by FIG. 20A to FIG. 20C As described, and also during priming, relative reciprocating movement is generated axially, rotationally, or axially and rotationally between the first interventional device and the second interventional device, such as by Fig.21A and Fig.21B as described.

[0284] In some embodiments, priming of the catheter can include vibrating at least a portion of the catheter and / or its associated hub (when an associated hub is included). For example, the vibration can be induced by a motor integrated into the hub of the catheter, or by a separate motor or vibration source placed on the catheter when priming. In some embodiments, at least a portion of the support platform on which the catheter and / or its associated hub is placed can be vibrated during priming of any one or more catheters to help remove air and / or microbubbles of air. Such vibration can be performed by a motor.

[0285] Example

[0286] Additional embodiments are disclosed in more detail in the examples below, which are not intended to limit the scope of the claims in any way.

[0287] Fig. 222 is a diagram of a test system for detecting bubble removal between concentrically stacked catheters. The test system includes an inner catheter 2108 located inside the lumen of an outer catheter 2106 stacked concentrically. The outer catheter 2106 is connected to a rotary hemostatic valve 2104. The hemostatic valve 2104 is connected to a syringe 2102 so that fluid injected using the syringe will flow through the lumen between the inner catheter 2108 and the outer catheter 2016. In the test system, the inner catheter 2108 has a diameter of approximately 0.071 inches. The outer catheter 2106 has a diameter of approximately 0.088 inches. The outer catheter 2106 is transparent to allow observation of bubbles within the lumen. The distal end of the outer catheter 2108 allows a small volume of fluid to leave the outer catheter. Fig.23A is a photograph showing catheter 2106 and catheter 2108 in a concentric stack prior to injection of fluid. Fig.23D is its diagram.

[0288] Example 1

[0289] In a first embodiment, syringe 2102 is used to inject water at a constant pressure of approximately 150 psi through hemostasis valve 2104 without moving catheter 2106 or catheter 2108. Fig. 23B is a photograph showing the conduit 2106 and the conduit 2108 after water is injected. Fig.23E is a diagram of this. Fig. 23B As shown, there are bubbles in the lumen between catheter 2106 and catheter 2108.

[0290] Example 2

[0291] In the second embodiment, the syringe 2102 is used to inject water at a constant pressure of about 150 psi through the hemostatic valve 2104. Shortly after the water injection begins, the axial reciprocating movement of the inner catheter 2108 is performed for about 10 seconds. The reciprocating movement is 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 catheter 2106 and catheter 2108 after axial reciprocating movement. Fig.23F is a diagram of this. Fig.23C As shown, the lumen between catheter 2106 and catheter 2108 is substantially free of air bubbles.

[0292] Example 3

[0293] In a third embodiment, an outer catheter of about 0.071 inches in diameter and an inner catheter of about 0.035 inches in diameter are used in a test system 2100, rather than the outer catheter 2106 and inner catheter 2108 described in Examples 1 and 2. A syringe 2102 is used to inject water at a constant pressure of about 150 psi through a hemostatic valve 2104 connected to the outer catheter. Shortly after the water is injected, an axial reciprocating movement of the inner catheter is performed for about 10 seconds. The reciprocating movement is performed at a frequency of about 1 Hz (or lower) and a stroke length of about 20 mm (or more). After the axial reciprocating movement, it is found by visual inspection that the lumen between the outer catheter and the inner catheter is substantially free of bubbles.

[0294] Control System

[0295] Fig.24 A schematic diagram of an example of a control system 4000 is shown, which can be used to electronically control the systems and components described herein and / or perform the methods described herein. The control system 4000 can be configured to automatically adjust various motors, hub adapters, hubs, interventional devices, fluidics components (e.g., valves, pumps, etc.), and / or any other components described herein in response to command input by an operator (e.g., a doctor). In response to the operator's command input, the control system 4000 can cause a series of response events to occur automatically.

[0296] In certain embodiments, the control system 4000 may include one or more processors 4002. The one or more processors 4002 may be configured to automatically adjust various system components described herein in response to operator command input, for example, using one or more controls 4004 of the control system 4000. Fig.24 4004. However, any appropriate number of controls may be provided to correspond to the various functions of the systems described herein. For example, in certain embodiments, each interventional device may have its own unique control 4004 or a set of controls 4004 that may control various functions of the interventional device (e.g., axial movement, rotational movement, fluid supply (e.g., saline, contrast agent, etc.), aspiration, etc.).

[0297] In some embodiments, one or more controls 4004 can control the priming function of one or more interventional devices. For example, one or more controls 4004 can be operated to cause the interventional device to perform a priming procedure, such as by FIG. 20A to FIG. 20CFor example, one or more controls 4004 may be operated to cause one or more interventional devices to move axially relative to one or more other interventional devices (e.g., by causing a corresponding hub and / or hub adapter to move axially). One or more controls 4004 may be operated to cause fluid to be introduced into the lumen of an interventional device, thereby pre-filling the interventional device.

[0298] In some embodiments, one or more controls 4004 can be operated to cause the interventional device to undergo a priming procedure, such as by FIG. 21A to FIG. 21B For example, one or more controls 4004 may be operated to cause one or more interventional devices to reciprocate (e.g., axially and / or rotationally reciprocate) relative to one or more other interventional devices (e.g., by reciprocating a corresponding hub and / or hub adapter). One or more controls 4004 may be operated to cause fluid to be introduced into the lumen macro of the interventional device, thereby pre-filling the interventional device (e.g., during relative reciprocation).

[0299] The processor 4002 may receive signals from one or more controls 4004 and, in response, initiate corresponding actions in the components of the systems described herein. For example, the processor 4002 may be configured to generate output signals that cause a responsive action to be performed by a component described herein.

[0300] Although the foregoing describes robotically driven interventional devices and manually driven interventional devices, these devices may be manually driven, robotically driven, or any combination of manually and robotically driven interventional devices, as will be understood by those skilled in the art in light of the disclosure herein.

[0301] The foregoing describes one specific embodiment of a robotic control system. A variety of different robotic control system structures can be made for supporting and axially advancing and retracting two or three or four or more components to robotically drive an interventional device, as will be understood by those skilled in the art in light of the disclosure herein.

[0302] Although the foregoing describes an interventional device driven by a drive stage, other suitable robotic drive systems or mechanisms may be used to drive the interventional device, as will be appreciated by those skilled in the art in view of the disclosure herein.

[0303] Various systems and methods are described herein primarily in the context of neurovascular access or surgery (e.g., neurothrombectomy). However, the catheters, systems (e.g., drive systems), and methods disclosed herein can be readily adapted for use in any of a wide variety of other diagnostic and therapeutic applications throughout the body, particularly including endovascular procedures, such as in the peripheral vascular system (e.g., deep vein thrombosis), central vascular system (pulmonary embolism), and coronary vascular system, as well as in other hollow organs or tubular structures in the body.

Claims

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 surgical catheter hub configured to adjust an axial position of the surgical catheter; a guide catheter hub configured to adjust an axial position of the guide catheter; and An access catheter hub is configured to adjust the axial and rotational position of the access catheter. 2 . The drive system of claim 1 , wherein the surgical catheter hub is further configured to laterally deflect a distal deflection region of the surgical catheter.

3. The drive system according to claim 1, wherein: The guidewire hub is configured to be connected to a guidewire hub adapter by magnetically connecting the guidewire hub to a first drive magnet; The access catheter hub is configured to be connected to an access catheter hub adapter by magnetically connecting the access catheter hub to a second drive magnet; The guide catheter hub is configured to be connected to a guide catheter hub adapter by magnetically connecting the guide catheter hub to a third drive magnet; and The surgical catheter hub is configured to be connected to a surgical catheter hub adapter by magnetically connecting the surgical catheter hub to a fourth drive magnet, wherein the first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet are independently movably carried by a drive stage.

4. The drive system according to claim 3 further includes a first driven magnet located on the guide wire hub, wherein the first driven magnet is configured to cooperate with the first driving magnet so that the first driven magnet moves in response to the movement of the first driving magnet.

5. A drive system according to claim 4, wherein the first drive magnet is configured to move outside the sterile area while being separated from the first driven magnet by a sterile area barrier, and the first driven magnet is within the sterile area.

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

7. The drive system of claim 5, further comprising a second driven magnet on the entry catheter hub, the second driven magnet being 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, wherein the second drive magnet is configured to move outside the sterile area while being separated from the second driven magnet by the barrier while the second driven magnet is within the sterile area.

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

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

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

11. The drive system of claim 1, wherein the surgical catheter is an embolic deployment catheter.

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

13. The drive system of claim 1, wherein the surgical catheter is a shunt deployment catheter.

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

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

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

17. The drive system of claim 1, wherein the surgical catheter is a catheter that facilitates percutaneous valve repair or replacement.

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

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

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

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