Contrast compatible guidewire and catheter stacks

Abstract

A system for delivering a fluid to a target site in a patient's vasculature includes a catheter and a guiding element, the catheter having a proximal end, a distal end, and a lumen defined by an inner surface of the catheter extending longitudinally through the catheter between the proximal and distal ends, the guiding element having a distal end, a proximal end, and an outer surface, the guiding element positioned within the lumen to create an area between the outer surface of the guiding element and the inner surface of the catheter having an effective cross-sectional area sized for fluid communication with the guiding element within the lumen. Also, a method for performing a neurovascular procedure includes providing a multi-catheter assembly including an access catheter, a guide catheter, and a treatment catheter, coupling the assembly to a robotic drive system, and injecting a contrast medium into the assembly without removing the guiding element.

Description

[Technical Field]

[0001] Incorporation by reference to priority applications Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet filed with this application are incorporated herein by reference under 37 CFR 1.57. This application claims the benefit of U.S. Provisional Application No. 63 / 477,370, filed December 27, 2022, the entire contents of which are incorporated herein by reference for all purposes and made a part hereof.

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

[0003] Various neurovascular procedures, including thrombectomy, diagnostic angiography, embolism coil deployment, and stent placement, can be accomplished via transvascular access. However, the delivery of neurovascular care is limited or delayed by a variety of challenges. For example, there are not enough trained interventionalists and centers to meet the current demand for neurointerventions. Neurointerventions are difficult, with complex setup requirements and demands on the surgeon's dexterity. Using both hands, surgeons must exercise precise control over three to four coaxial catheters while managing the fluoroscopy system and patient positioning. Long, tortuous anatomical structures require delicate and precise manipulation. Inadvertent catheter movement can occur due to the storage and release of energy caused by frictional interactions between the coaxial shaft and the patient's vasculature. The supra-aortic access required to reach the neurovasculature is difficult to achieve, especially in Type III arches. For example, during current neurothrombectomy procedures, physicians must remove the guidewire from the catheter to perform dye injection. Many dye injections are required to navigate through a complex vascular system to the brain; therefore, guidewires must be removed 10 or more times during a single procedure. The additional step of removing the guidewire increases the duration of the procedure, increasing cost and time, and incurring the risk of introducing air bubbles into the patient. Even if supra-aortic access is achieved, adapting the system for neurovascular treatment remains time-consuming, requiring removal of the guidewire and access catheter and the addition of a treatment catheter (and possibly one or more additional catheters) to the stack.

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

[0005] According to one aspect of the present disclosure, a supra-aortic access robotic control system is provided. The supra-aortic access robotic control system is capable of delivering fluid to a target site in a patient's vasculature. The system can include a catheter including a tubular shaft, a lumen extending longitudinally therethrough, a proximal end, and a distal end, and a guiding element, which is often a guidewire but can be another elongated medical device, including, but not limited to, a catheter. The guiding element and catheter are sized so that the guiding element can be positioned within the lumen of the catheter. For ease of reference when describing aspects of providing fluid to a target site through a lumen of a catheter with the guiding element positioned inside the lumen, the "guiding element" is often referred to herein simply as the "guidewire," and in many use cases, the guiding element is a guidewire. Thus, unless the context of the description dictates otherwise, references to a "guidewire" or a "guiding element" can refer to a guidewire, a catheter, or another elongated medical device. The guidewire can be configured to reside inside the catheter lumen, creating a space with a circular cross-section, and can be navigated by a user to a target site within a patient's vasculature, with the distal end of the catheter also being advanced to the target site. The guiding element can include surfaces with different properties, such as a hydrophilic coating at its distal end and a hydrophobic coating at its proximal end. In one example, the hydrophobic coating is polytetrafluoroethylene (PTFE) or a PTFE-based composition. The system can also include a pump, syringe, or injector configured to deliver fluid through the proximal end of the catheter at a pressure to achieve a desired flow rate, propelling the fluid through the annular lumen and out the distal end at the target site.In some embodiments, the catheter lumen that communicates fluid can have an inner diameter (ID) of at least about 0.045". For example, the ID can be between about 0.045" and about 0.048". The catheters and guidewires are configured to allow sufficient fluid to flow through the lumen even when the guidewire is positioned all or partially within the lumen (which reduces the effective cross-sectional area of ​​the lumen). "Effective cross-sectional area" refers to the cross-sectional area of ​​the catheter lumen available for fluid communication. In one example, the effective cross-sectional area of ​​a catheter lumen can be determined by subtracting the cross-sectional area of ​​the guiding element within the lumen from the cross-sectional area of ​​the lumen. In some embodiments, the catheters and guidewires are structured so that the lumen has an effective cross-sectional area (when the guidewire is positioned within the lumen) that is greater than about 0.001257 square inches. In some embodiments, the catheters and guidewires are structured so that the lumens have an effective cross-sectional area greater than about 0.001407 square inches (i.e., when the guidewire is positioned within the lumen). In some embodiments, the fluid can be a contrast medium. In some embodiments, the guidewire can have a diameter of 0.014 inches, 0.018 inches, or between 0.014 inches and 0.018 inches. In some embodiments, the guidewire can have a diameter of 0.018 inches, 0.020 inches, or between 0.018 inches and 0.020 inches. In some embodiments, the guidewire can have a diameter of 0.024 inches, or between 0.020 inches and 0.024 inches.Although some of the embodiments disclosed herein are described as including a guidewire, any suitable guiding element (e.g., guidewire, catheter, etc.) capable of assisting in navigating a catheter through the human anatomy can be used, where it should be understood that the cross-sectional shape (e.g., circular) and size (e.g., diameter) of the guiding element relative to the cross-sectional shape and size of the catheter's lumen when the guiding element is positioned within the lumen provides sufficient space within the lumen for the flow of fluid at a desired flow rate. The desired flow rate of fluid can be provided for a predetermined amount of time to provide the desired volume of fluid. The desired flow rate can be a predetermined rate. For example, even when the guiding element is positioned within the lumen, sufficient space exists within the catheter's lumen for a specific volume of contrast medium to flow through the catheter's lumen and out the distal end of the catheter when under a specific amount of pressure (e.g., less than or equal to about 400 psi). Thus, the terms guidewire and guiding element can be used interchangeably unless the context and / or the specific use of the terms dictates otherwise. In some embodiments, the distal end of the catheter can be thermoformed. In some embodiments, the distal end of the catheter can include a hypotube. In some embodiments, the hypotube can be laser cut. In some embodiments, the catheter wall can include a braided reinforcing layer of stainless steel wire surrounding some or all of the lumen. In some embodiments, the guidewire can have a hydrophilic coating.

[0006] According to another aspect of the present disclosure, there is further provided a method for delivering a fluid to a target site in a patient's vasculature, the method including: navigating a guidewire to the target site; navigating a lumen of the catheter over the guidewire until a distal end of the catheter is positioned at the target site; coupling a proximal end of the catheter to a fluid pump or injector; and pumping the fluid through the proximal end of the catheter, along the annular lumen, and out the distal end to the target site. In some embodiments, the lumen can have an inner diameter of at least 0.046 inches. In some embodiments, the lumen can have an effective cross-sectional area greater than 0.001257 square inches. In some embodiments, the fluid can be a contrast medium. In some embodiments, the guidewire can have a diameter of 0.018 inches, 0.020 inches, or between 0.018 inches and 0.020 inches. In some embodiments, the guidewire can have a diameter of 0.024 inches, or between 0.020 inches and 0.024 inches. In some embodiments, the guidewire can have a diameter of 0.014 inches, 0.018 inches, or between 0.014 inches and 0.018 inches. In some embodiments, the distal end can be thermoformed. In some embodiments, the distal end can include a hypotube. In some embodiments, the hypotube can be laser cut. In some embodiments, the lumen can further include a braided reinforcement layer of stainless steel wire. In some embodiments, the guidewire can have a hydrophilic coating.

[0007] Another innovation includes a system for delivering a fluid to a target site in a patient's vasculature, the system including: a catheter including a tubular catheter shaft having a proximal end, a distal end, and a lumen defined by an interior surface of the catheter shaft extending longitudinally through the catheter shaft between the proximal and distal ends; and a guiding element having a distal end, a proximal end, and an exterior surface positioned within the lumen and configured to create an effective cross-sectional area for fluid communication between the exterior surface of the guiding element and the interior surface of the catheter, the effective cross-sectional area being greater than or equal to about 0.001257 square inches, the system being configured to move the catheter and guiding element, the guiding element moving the catheter. The system includes a guiding element, the guiding element and the distal end of the catheter being adapted to advance toward the target site while the guiding element is at least partially within the lumen of the catheter; and a contrast pump coupled to the catheter in fluid communication with the lumen, the system being configured to operate the contrast pump to provide contrast medium into the proximal end of the catheter at a pump pressure less than or equal to about 400 psi while the guiding element is at least partially positioned within the lumen of the catheter, the provided contrast medium propagating along the exterior surface of the guiding element through the lumen of the catheter and exiting the distal end of the catheter, the effective cross-sectional area allowing a predetermined flow rate of the contrast medium to exit the distal end of the catheter. In some examples, the fluid is some fluid other than the contrast medium. In some embodiments, the predetermined flow rate is at or about 3 cc / sec. In some embodiments, the predetermined flow rate is at least 3 cc / sec. In some embodiments, the effective cross-sectional area (within the lumen when the guiding element is at least partially positioned within the catheter) can be annular in shape or an eccentric annular in shape.In some embodiments, the effective cross-sectional area can be greater than or equal to about 0.001257 square inches, which provides a channel within the lumen for communicating a fluid (e.g., a contrast medium) through the catheter and out the distal end of the catheter at a desired flow rate. In some embodiments, the effective cross-sectional area can be greater than or equal to about 0.001407 square inches, which provides a channel within the lumen for communicating a fluid (e.g., a contrast medium) through the catheter and out the distal end of the catheter at a desired flow rate. In one example, the desired flow rate is at least about 2 cc / sec. In another example, the desired flow rate is at least about 3 cc / sec. The guiding element can be, for example, a guidewire, a catheter, or another elongated medical device. In some examples, the guiding element has a diameter of about 0.014 inches or about 0.020 inches. In some examples, the guiding element has a diameter between about 0.014 inches and about 0.020 inches. In some examples, the diameter of the catheter lumen (i.e., the inner diameter of the catheter) is about 0.045 inches or about 0.049 inches, or the diameter of the catheter lumen is between about 0.045 inches and about 0.049 inches. In some examples, the distal end of the catheter is thermoformed. In some examples, the distal end of the catheter includes a hypotube, which can be a laser-cut hypotube. In some examples, the catheter includes a braided reinforcing layer of stainless steel wire around at least a portion of the lumen.In some embodiments of the system including multiple catheters, the catheter is a first catheter, and the system further includes a second catheter and a third catheter, the second catheter and the third catheter being positioned such that the guiding element, the first catheter, the second catheter, and the third catheter are concentrically arranged such that at least a portion of the guiding element, the first catheter, and the second catheter are inside the third catheter when providing contrast medium through the lumen of the first catheter. In some embodiments, the guiding element includes a hydrophilic coating.

[0008] Another innovation includes a method for delivering a fluid to a target site in a patient's vasculature using a robotic catheter system, the method comprising: moving a distal end of a guiding element toward the target site; moving the distal end of the catheter toward the target site while at least a portion of the guiding element is positioned within a lumen of the catheter; and providing a contrast medium into the proximal end of the catheter while at least a portion of the guiding element is positioned within the lumen of the catheter, the provided contrast medium propagating along an outer surface of the guiding element, through the lumen, and exiting the distal end of the catheter, the lumen and guiding element being sized to create an area between the outer surface of the guiding element and an inner surface of the catheter that provides a predetermined flow rate of the contrast medium from the distal end of the catheter at a pump pressure less than or equal to 400 psi. The fluid flow rate is affected by the pump pressure and the effective cross-sectional area. Thus, with a pump pressure of less than or equal to 400 psi, the effective cross-sectional area is sized to provide a flow rate of 3 cc / sec or about 3 cc / sec. In some embodiments, the effective cross-sectional area is sized to provide a predetermined flow rate of at least about 3 cc / sec. In one example, the desired flow rate is at least about 2 cc / sec. In some embodiments, the effective cross-sectional area is annular in shape, or the effective cross-sectional area is eccentric annular in shape. In some embodiments, the effective cross-sectional area is greater than or equal to 0.001257 square inches, or the effective cross-sectional area is greater than or equal to about 0.001257 square inches. In some embodiments, the effective cross-sectional area is greater than or equal to 0.001407 square inches, or the effective cross-sectional area is greater than or equal to about 0.001407 square inches.In some examples, the guiding element has a diameter of about 0.014 inches or about 0.020 inches, or the guiding element has a diameter between about 0.014 inches and about 0.020 inches. In some examples, the catheter has a lumen diameter (inner diameter) of about 0.045 inches or about 0.049 inches, or the catheter has a lumen diameter (inner diameter) between about 0.045 inches and about 0.049 inches. In some embodiments, the distal end of the catheter is thermoformed. The method can further include providing a contrast medium while moving at least one of the guiding element or the catheter toward the target site. In some embodiments, the catheters are a first catheter, a second catheter, and a third catheter, and the first catheter, the second catheter, and the third catheter are positioned such that the guiding element, the first catheter, the second catheter, and the third catheter are concentrically disposed such that at least a portion of the guiding element, the first catheter, and the second catheter are inside the third catheter when providing contrast medium through the lumen of the first catheter. In some embodiments, the guiding element is coupled to a first hub, the catheters are coupled to a second hub, the first hub is magnetically coupled to a first carriage of the drive assembly through a sterile barrier, and the second hub is magnetically coupled to a second carriage of the drive assembly through a sterile barrier, and moving the distal end of the guiding element and the distal end of the catheters includes moving the first carriage and moving the second carriage. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 is a schematic perspective view of an interventional setup having an imaging system, a patient support table, and a robotic drive system according to the present disclosure. [Figure 2]FIG. 1 is a longitudinal cross-sectional view showing the concentric relationship between a guidewire with two degrees of freedom, an access catheter with three degrees of freedom, and a guide catheter with one degree of freedom. [Figure 3A] FIG. 1 is an exploded schematic view of an interventional device hub separated from a support table by a sterile barrier. [Figure 3B] FIG. 10 shows an alternative sterility barrier in the form of a shipping tray having one or more storage channels for carrying interventional devices. [Figure 3C] FIG. 10 shows an alternative sterility barrier in the form of a shipping tray having one or more storage channels for carrying interventional devices. [Figure 3D] FIG. 10 shows an alternative sterility barrier in the form of a shipping tray having one or more storage channels for carrying interventional devices. [Figure 3E] FIG. 10 shows an alternative sterility barrier in the form of a shipping tray having one or more storage channels for carrying interventional devices. [Figure 3F] FIG. 10 shows an alternative sterility barrier in the form of a shipping tray having one or more storage channels for carrying interventional devices. [Figure 3G] 10A-10C show alternative sterility barrier embodiments having convex drive surfaces. [Figure 3H] 10A-10C show alternative sterility barrier embodiments having convex drive surfaces. [Figure 3I] 10A-10C show alternative sterility barrier embodiments having convex drive surfaces. [Figure 3J] 10A-10C show alternative sterility barrier embodiments having convex drive surfaces. [Figure 3K] 10A-10C show alternative sterility barrier embodiments having convex drive surfaces. [Figure 3L] 3A-3K depict examples of hubs that may be used with the sterility barriers of FIGS. 3G-3K. [Figure 3M] 3A-3K depict examples of hubs that may be used with the sterility barriers of FIGS. 3G-3K. [Figure 4]FIG. 1 is a schematic elevational cross-section through a hub adapter having a drive magnet separated from an interventional device hub and driven magnet by a sterile barrier. [Figure 5A] FIG. 10 is a diagram illustrating a schematic of an interventional device assembly having three interventional devices. [Figure 5B] FIG. 10 is a diagram illustrating a schematic diagram of an interventional device assembly having four interventional devices. [Figure 6] FIG. [Figure 7] FIG. 10 is a close-up view of the motor-driven end of the support table. [Figure 8] 1 is an elevational section through the motor and belt drive assembly. [Figure 9] FIG. 10 is a close-up view of the pulley end of the support table. [Figure 10] This is an elevational section through a belt pulley. [Figure 11] FIG. 5C is a side cross-sectional view through a distal portion of a catheter such as either of the catheters shown in FIGS. 5A and 5B. [Figure 12A] FIG. 10 is a diagram illustrating a schematic of a force sensor integrated into the sidewall of a catheter. [Figure 12B] FIG. 10 is a diagram illustrating a schematic of a force sensor integrated into the sidewall of a catheter. [Figure 13A] 10A and 10B are diagrams illustrating schematically a sensor for measuring the elastic force in the magnetic coupling between a hub and a corresponding carriage. [Figure 13B] 10A and 10B are diagrams illustrating schematically a sensor for measuring the elastic force in the magnetic coupling between a hub and a corresponding carriage. [Figure 14] FIG. 10 schematically illustrates a dual-encoder torque sensor for use with a catheter of the present disclosure. [Figure 15] 10A-10C illustrate a clot capture and visualization device that may be integrated into the hub and / or connected to a suction line. [Figure 16A]10A-10C illustrate exemplary control mechanisms for operating interventional devices driven by respective hubs. [Figure 16B] 10A-10C illustrate exemplary control mechanisms for operating interventional devices driven by respective hubs. [Figure 16C] 10A-10C illustrate exemplary control mechanisms for operating interventional devices driven by respective hubs. [Figure 17] FIG. 1 is a side schematic view of an interventional device assembly for supra-aortic access and neurointerventional procedures. [Figure 18] 1A-1C illustrate side cross-sectional views of two example catheters, at least a portion of which (e.g., the tip) is laser cut hypotube. [Figure 19] FIG. 10 is a close-up view of an example of a laser cut hypotube. [Figure 20A] 1A-1C depict an exemplary sequence of steps for introducing a catheter assembly configured to provide supra-aortic access and neurovascular site access. [Figure 20B] 1A-1C depict an exemplary sequence of steps for introducing a catheter assembly configured to provide supra-aortic access and neurovascular site access. [Figure 20C] 1A-1C depict an exemplary sequence of steps for introducing a catheter assembly configured to provide supra-aortic access and neurovascular site access. [Figure 20D] 1A-1C depict an exemplary sequence of steps for introducing a catheter assembly configured to provide supra-aortic access and neurovascular site access. [Figure 20E] 1A-1C depict an exemplary sequence of steps for introducing a catheter assembly configured to provide supra-aortic access and neurovascular site access. [Figure 21] 1A-1C are diagrams illustrating schematically embodiments of mechanical couplings between a driving mechanism and a driven mechanism. [Figure 22A]1A-1C depict an exemplary sequence of steps for priming a catheter assembly in a stacked configuration. [Figure 22B] 1A-1C depict an exemplary sequence of steps for priming a catheter assembly in a stacked configuration. [Figure 22C] 1A-1C depict an exemplary sequence of steps for priming a catheter assembly in a stacked configuration. [Figure 23A] 1A-1C depict an exemplary sequence of steps for priming a catheter assembly in a stacked configuration. [Figure 23B] 1A-1C depict an exemplary sequence of steps for priming a catheter assembly in a stacked configuration. [Figure 24] FIG. 23 depicts an exemplary test system for the priming process depicted in FIGS. 23A-23B. [Figure 25A] FIG. 1 depicts an example of a catheter assembly. [Figure 25B] FIG. 1 illustrates an example of a catheter assembly after a priming procedure. [Figure 25C] 1A-1C depict an example of a catheter assembly after a priming procedure involving relative movement between adjacent catheters. [Figure 25D] 25A-25C illustrate the exemplary catheter assembly. [Figure 25E] 25A-25C illustrate the exemplary catheter assembly. [Figure 25F] 25A-25C illustrate the exemplary catheter assembly. [Figure 26A] FIG. 1 illustrates one embodiment of a one-channel fluidics management system. [Figure 26B] FIG. 1 illustrates one embodiment of a three-channel fluidics management system. [Figure 27] FIG. 1 is a schematic diagram of an example three-channel fluidics system. [Figure 28]FIG. 2 is another schematic diagram of an example fluidics system. [Figure 29] FIG. 2 is another schematic diagram of an example fluidics system. [Figure 30] FIG. 1 illustrates an example of a fluidics system. [Figure 31] FIG. 1 illustrates an example embodiment of a saline subsystem. [Figure 32] FIG. 1 illustrates an example embodiment of a contrast agent subsystem. [Figure 33] FIG. 1 illustrates an example embodiment of a vacuum / aspiration ("V / A") subsystem ("vacuum subsystem"). [Figure 34] FIG. 10 illustrates an example of a catheter coupled to an embodiment of a hub and a tubing set connected at a distal end to the hub and at a proximal end to a cassette, the tubing set including saline tubing, contrast tubing, and vacuum tubing, and may include electrical connections, the tubing set forming part of a fluid communication system connecting the hub to the saline subsystem, contrast subsystem, and vacuum subsystem. [Figure 35] 10A-10C illustrate another example of a catheter coupled to an embodiment of a hub. [Figure 36] FIG. 1 illustrates an example of a tubing set that is part of a fluid communication system that provides channels for communicating substances (e.g., air, fluid, and / or materials) between multiple catheters and a saline subsystem, a contrast subsystem, and a vacuum subsystem, the tubing set being coupled to a cassette at a proximal end of the tubing set and to multiple hubs at a distal end of the tubing set, and in this example, the tubing set also including electrical connections between the cassette and the multiple hubs. [Figure 37]FIG. 1 illustrates a schematic diagram of an example robotic catheter system, including a remotely positioned system ("remote system") and a locally positioned system ("local system"), according to some embodiments, and also illustrates an example of specific components of the local system, including specific components of a fluid management system ("fluidics system"), including operable components operated by a controller and sensors that provide information to the controller for controlling the fluidics system and other aspects of the robotic catheter system. [Figure 38] 1A-1C illustrate example embodiments of a cassette and pump station illustrating certain components of the cassette (e.g., valves, electrical connections) and corresponding components of the pump station (e.g., motor, electrical connections). [Figure 39] 10A-10C illustrate examples of contrast injection processes that may be performed when the fluid system is in a contrast injection state. [Figure 40] FIG. 10 illustrates a process by which the system determines whether it is safe to inject contrast. [Figure 41] FIG. 10 illustrates an example of a contrast agent subsystem configuration, in which an insertion catheter coupled to the hub is selected for injecting contrast agent. [Figure 42] 10A-10C illustrate examples of hub configurations corresponding to selected catheters when contrast is injected. [Figure 43] 1 illustrates an example of a selected catheter hub configuration configured to inject a saline bolus. [Figure 44] 1 illustrates an overview of an exemplary trial sequence for a contrast injection study. [Figure 45] 1 is a graphical representation of the relationship between flow rate and catheter length. [Figure 46] 1 is a graphical representation of the relationship between flow rate and guidewire diameter. [Figure 47]1 is a graphical representation of the relationship between output flow rate and input flow rate. [Figure 48] 1 is a graphical representation of the relationship between output flow rate and injection volume. [Figure 49] 1 is a graphical representation of the relationship between pressure, flow rate, and viscosity. [Figure 50] FIG. 1 is a schematic diagram of an example control system. [Figure 51] FIG. 1 depicts an exemplary test system setup for glycerin viscosity testing. [Figure 52] 1 is a representation of an example of a distal end view of a concentric stack including a guide catheter, a treatment catheter, an insertion catheter, and a guiding element (e.g., a guidewire). DETAILED DESCRIPTION OF THE INVENTION

[0010] In certain embodiments, a system is provided for advancing a guide catheter from femoral or radial artery access into the ostium of one of the great vessels above the aortic arch, thereby achieving supra-aortic access. The surgeon can then take over and advance an interventional device into the cerebral vasculature via the robotically placed guide catheter.

[0011] In some implementations, the system can additionally be configured to robotically obtain intracranial vascular access and to perform aspiration thrombectomy or other neurovascular procedures.

[0012] The drive table can be positioned on or near the patient and can be configured to axially advance, retract, and in some cases rotate and / or laterally deflect two, three, or more different (e.g., concentrically or side-by-side oriented) intravascular devices. The hubs are movable along paths along the surface of the drive table to advance or retract the interventional devices as desired. Each hub can also contain mechanisms for rotating or deflecting the device as desired and is connected to fluid delivery tubing (not shown) of the type conventionally attached to catheter hubs. Each hub can be in electrical communication with an electronic control system via either a hardwired connection, an RF wireless connection, or a combination of both.

[0013] Each hub is independently movable across the surface of a sterile field barrier membrane carried by a drive table. In some embodiments, each hub is releasably magnetically coupled to a unique drive carriage on the table side of the sterile field barrier. The drive system independently moves each hub proximally or distally across the surface of the barrier to move a corresponding interventional device proximally or distally within the patient's vasculature.

[0014] The carriage on the drive table, which magnetically couples with the hub to provide linear motion actuation, is universal. Catheter / guidewire functionality is provided based on what is contained in the hub and shaft design. This allows for flexibility in configuring the system to perform a wide range of procedures using a wide variety of interventional devices on the same drive table. Additionally, the interventional devices and methods disclosed herein can be easily adapted for use with any of a wide variety of other drive systems (e.g., any of a wide variety of robotic surgical drive systems).

[0015] 1 is a schematic perspective view of an interventional setup 10 having a patient support table 12 for supporting a patient 14. An imaging system 16 can be provided along with a robotic interventional device drive system 18 according to the present disclosure.

[0016] Drive system 18 can include, for example, a support table 20 for supporting a guidewire hub 26, an access catheter hub 28, and a guide catheter hub 30. In this context, the term "access" catheter can be any catheter having a lumen with at least one distally or laterally facing distal opening that can be utilized to aspirate thrombus, to provide access for additional devices to be advanced therethrough, or to inject saline, contrast media, or therapeutic agents.

[0017] Depending on the desired clinical procedure, more or fewer interventional device hubs may be provided. For example, in certain embodiments, a diagnostic angiography procedure may be performed using only a guidewire hub 26 and an access catheter hub 28 for driving a guidewire and an access catheter (in the form of a diagnostic angiography catheter), respectively. Multiple interventional devices 22 extend between the support table 20 and (in the illustrated example) a femoral access point 24 on the patient 14. Depending on the desired procedure, access may be achieved by percutaneous or cut-down access to any of various arteries or veins, such as the femoral or radial arteries. Although disclosed herein primarily in the context of neurovascular access and procedures, the robotic drive systems and associated interventional devices can be readily adapted for use in a wide variety of additional medical interventions, such as in the peripheral and coronary arterial and venous vasculature, the gastrointestinal system, the lymphatic system, cerebrospinal fluid lumens or spaces (e.g., the spinal canal, ventricles, and subarachnoid space), the pulmonary airways, treatment sites reached via transurethral or urethral or tubal navigation, or in other hollow organs or structures within the body (e.g., in intracardiac or structural cardiac applications such as valve repair or replacement, or in any endoluminal procedure).

[0018] For example, a display 23 for viewing fluoroscopic images, catheter data (e.g., fiber Bragg grating optical fiber sensor data or other force or shape sensing data), or other patient data, etc. may be carried by support table 20 and / or patient support 12. Alternatively, the physician input / output interface including display 23 may be remote from the patient, e.g., behind radiation shielding, in a different room than the patient, or in a different facility than the patient.

[0019] In the illustrated example, a guidewire hub 26 is carried by the support table 20 and is movable along the table to advance a guidewire into and out of the patient 14. An access catheter hub 28 is also carried by the support table 20 and is movable along the table to advance an access catheter into and out of the patient 14. The access catheter hub can also be configured to rotate the access catheter in response to operation of a rotation control and to laterally deflect a deflectable portion of the access catheter in response to operation of a deflection control.

[0020] FIG. 2 is a longitudinal cross-sectional view that schematically illustrates the motion relationships between a guidewire 27 having two degrees of freedom (axial and rotational), an access catheter 29 having three degrees of freedom (axial, rotational, and lateral deflection), and a guide catheter 31 having one degree of freedom (axial).

[0021] 3A, support table 20 includes a drive mechanism, described in more detail below, for independently driving guidewire hub 26, access catheter hub 28, and guide catheter hub 30. Anti-buckling features 34 can be provided in the proximal anti-buckling zone to resist buckling of the portion of the interventional device spanning the distance between support table 20 and femoral artery access point 24. Anti-buckling features 34 can include a plurality of concentric, telescoping, axially extendable and collapsible tubes through which the interventional device extends.

[0022] Alternatively, one or more proximal segments of the device shaft can be configured with enhanced stiffness to reduce buckling under compression. For example, a proximal reinforced segment can extend distally from the hub for a distance of at least about 5 or 10 centimeters, but typically no more than about 120 or 100 centimeters, to support the device between the hub and the access point 24 on the patient. Reinforcement can be achieved by using metal or polymer tubing or by embedding at least one or two or more axially extending elements, such as elongated wires or ribbons, into the wall of the device shaft. In some implementations, the extending elements are hollow and can protect against wear, buckling, or damage at the input and output of the hub. In some embodiments, the hollow extending elements can be hollow flexible coatings attached to the hub. The hollow extending elements (e.g., hollow flexible coatings) can cover a portion of the device shaft when threaded through the hub. In some embodiments, the hollow extending element is a set of telescoping sections that nest inside each other and surround the shaft between the hubs. In some embodiments, the hollow extending element has a proximal end (closest to the insertion point) and a distal end (farthest from the insertion point), each end coupled to a hub. In some embodiments, the extending element is releasably coupled to the hub at least one end. In some embodiments where the hollow extending element is a coating, the coating can be attached to a portion of the hub such that passing a catheter device through the hub 26, 28, or 30 also passes the catheter device through the coating.In some implementations, an anti-buckling device can be placed on or around or surrounding the device shaft to avoid misalignment or insertion angle errors between the hubs or between the hub and the insertion point. The anti-buckling device can be a laser-cut hypotube, a spring, an expandable tube, or tensioned split tubing, etc.

[0023] In some implementations, multiple deflection sensors can be placed along the catheter length to identify buckling. Identifying buckling can be performed by detecting distal advancement of the hub while the distal tip of the catheter or interventional device is not being moved. In some implementations, buckling can be detected by detecting an energy load (e.g., due to friction) between the catheter shaft.

[0024] Alternatively, a thin tubular stiffening structure can be embedded within or carried on the exterior of the device wall, such as a tubular polymer extrusion or length of hypotube. Alternatively, a removable stiffening mandrel can be placed within the lumen in the proximal segment of the device and removed proximally following distal advancement of the hub toward the patient access site to prevent buckling of the proximal shaft during distal advancement of the hub. Alternatively, one or more proximal segments of the device shaft can be constructed as a tubular hypotube, which can be machined (e.g., by laser) so that its mechanical properties vary along its length. This proximal segment can be formed from stainless steel, nitinol, and / or cobalt-chromium alloy, optionally in combination with a polymer component capable of providing lubricity and hydraulic sealing. In some embodiments, this proximal segment can be formed from a polymer such as polyetheretherketone (PEEK). Alternatively, the wall thickness or diameter of the interventional device can be increased in the anti-buckling zone.

[0025] In certain embodiments, a device shaft with high stiffness (e.g., axially and torsionally) can provide improved motion transmission from the proximal end of the device shaft to the distal end of the device shaft. For example, the device shaft can be more responsive to motion applied at the proximal end. Such embodiments can be advantageous for robotic actuation in the absence of tactile feedback to the user.

[0026] In some embodiments, a flexible coating can be applied to the device shaft and / or hub to reduce frictional forces between the device shaft and / or hub and a second device shaft as the second device shaft passes through it.

[0027] The interventional device hub can be separated from the support table 20 by a sterile barrier 32. The sterile barrier 32 can comprise a thin plastic film, such as polyethylene terephthalate (PET), polyethylene terephthalate glycol (PETG), polyethylene terephthalate (PETE), high-density polyethylene (HDPE), polyvinyl chloride (PVC), low-density polyethylene (LDPE), polypropylene (PP), polystyrene (PS), or styrene. This allows the support table 20 and associated drive systems to reside on the non-sterile side (below) of the sterile barrier 32. The guidewire hub 26, access catheter hub 28, guide catheter hub 30, and associated interventional devices are all on the sterile side (above) of the sterile barrier 32. The sterile barrier is preferably waterproof and can also serve as a tray used in packaging the interventional devices (discussed further below). The interventional devices can be provided individually or as a coaxially pre-assembled kit, which is shipped and stored in a tray and enclosed in sterile packaging.

[0028] 3B-3F schematically illustrate an alternative sterile barrier in the form of a dual-function sterile barrier for placement on a support table during an interventional procedure and a shipping tray with one or more storage channels for carrying sterile interventional devices. The sterile barrier can also act as a sterile work surface for preparing catheters or other devices during the procedure.

[0029] 3B and 3C, a sterility barrier 32 is shown in the form of a pre-shaped tray to fit over the elongated support table 20. In use, the elongated support table 20 is positioned below the sterility barrier 32. The sterility barrier 32 extends between a proximal end 100 and a distal end 102 and includes an upper support surface 104 for supporting an interventional device hub. In one implementation, the support surface 104 has an axial length greater than the length of the intended interventional device in a linear drive configuration.

[0030] The length of the support surface 104 will typically be at least about 100 centimeters and will be in the range of about 100 centimeters to about 2.7 meters. Shorter lengths can be utilized in systems configured to advance the drive coupler along an arcuate path. In some embodiments, two or more support surfaces can be used in place of a single support surface 104. The two or more support surfaces can have a combined length between 100 centimeters and about 2.7 meters. The width of the linear drive table is preferably no more than about 30 centimeters to about 80 centimeters.

[0031] At least a first channel 106 may be provided, extending axially for at least a portion of the length of the support table 20. In the illustrated implementation, the first channel 106 extends the entire length of the support table 20. Preferably, the first channel 106 has a length sufficient to hold an interventional device and a width and depth sufficient to hold a corresponding hub (e.g., by providing lateral support to prevent dislodgement of the hub when force is applied to the hub). The first channel 106 is defined in the floor 108, the outer sidewall 110, and the inner sidewall 111 and forms an upwardly facing concave surface. Optionally, a second channel 112 may be provided. The second channel 112 may be located on the same or opposite side of the upper support surface 104 from the first channel 106. Two, three or more additional recesses, such as additional channels or wells, can be provided to hold additional medical devices or supplies that may be useful during the interventional procedure, as well as to collect fluids and act as washing reservoirs for the catheter and related devices.

[0032] 3D, guide catheter hub 30 is shown positioned on upper support surface 104 and magnetically coupled to a corresponding coupler holding a drive magnet positioned below sterile barrier 32. Access catheter hub 28 and access catheter 29, as well as guidewire hub 26 and guidewire 27, are shown to reside within first channel 106, e.g., prior to introduction through guide catheter 31 or following removal from guide catheter 31.

[0033] An interventional device can be positioned in the channel 106 and enclosed within a sterile barrier for shipping. At the clinical site, the upper panel of the sterile barrier can be removed, or the tubular sterile barrier packaging can be opened and axially removed from the support table 20 and sterile barrier 32 assembly, exposing the sterile top side of the sterile barrier tray and any contained interventional device. The interventional device can be carried separately in the channel or pre-assembled into an access or treatment assembly, which are discussed in additional detail below.

[0034] Figures 3D-3F illustrate the support table with the sterile barrier in place, and Figure 3E illustrates the interventional device configured into the access assembly for aortic access following coupling of the access assembly to a corresponding carriage below the sterile barrier. The access assembly can be pre-assembled with the guidewire fully advanced through the access catheter and the access catheter fully advanced through the guide catheter. In embodiments where the access catheter or other catheters are pre-shaped (i.e., not pre-curved or straight), the guidewire and / or outer catheter can be positioned so that the relatively stiff sections do not overlap the curved, stiffer sections of the pre-shaped catheter, e.g., to avoid creep or straightening of the pre-shaped catheter and / or to avoid introducing a curve into an otherwise straight catheter. The access assembly can be lifted from the channel 106 and positioned on the support surface 104 for coupling to the respective drive magnets and introduction into the patient. The guide catheter hub 30 is the distal-most hub. The access catheter hub 28 is positioned proximally to the guide catheter hub to allow the access catheter 29 to extend distally through the guide catheter. The guidewire hub 26 is positioned proximally most to allow the guidewire 27 to be advanced through the access catheter 29 and the guide catheter 31.

[0035] The treatment assembly is shown in FIG. 3F following its introduction through the guide catheter 31 used to achieve supra-aortic access. In this implementation, the guide catheter 31 remains the most distal of the interventional devices. A first treatment catheter 120 and corresponding hub 122 are shown extending through the guide catheter 31. An optional second treatment catheter 124 and corresponding hub 126 are shown extending through the first treatment catheter 120. A guidewire 27 extends through at least a portion of the second treatment catheter 124 in a rapid exchange version of the second treatment catheter 124, or through the entire length of the second treatment catheter 124 in an over-the-wire implementation.

[0036] As discussed in more detail in connection with FIG. 17 , a multi-catheter stack can be utilized to achieve both access and endovascular procedures without the need for catheter exchange. This can be accomplished with either manually or robotically driven procedures. In some embodiments, determining an appropriate catheter stack, each having specific dimensions, along with a fluidics system configured to perform contrast injection using the catheter stack configuration, facilitates access, endovascular procedures, and contrast injection without the need for catheter exchange. In one example, the guide catheter 31 can include a catheter having an inner diameter of at least about 0.08 inches, and in one implementation, an inner diameter of about 0.088 inches. The first treatment catheter 120 can include a catheter having an inner diameter within a range of about 0.065 inches to about 0.075 inches, and in one implementation, the catheter 120 has an inner diameter of about 0.071 inches. The second treatment catheter 124 can be an access catheter having an OD sized to allow advancement through the first treatment catheter 120. The second treatment catheter can be steerable and have a deflection control 2908 configured to laterally deflect the distal end of the catheter, and the second treatment (access) catheter can have an inner lumen sized to allow an appropriately sized guidewire to remain inside the second treatment catheter while performing contrast injection through the second treatment catheter.

[0037] In certain embodiments, catheter 31 can be a "large bore" access or guide catheter having an inner diameter of at least about 0.075 inches or at least about 0.080 inches. Catheter 120 can be an aspiration catheter having an inner diameter in the range of about 0.060 inches to about 0.075 inches. Catheter 124 can be a steerable catheter with a deflectable distal tip having an inner diameter in the range of about 0.025 inches to about 0.050 inches. Guidewire (or guiding element) 27 can have an outer diameter in the range of about 0.014 inches to about 0.020 inches. In one example, catheter 31 can have an inner diameter of about 0.088 inches, catheter 120 can have an inner diameter of about 0.071 inches, catheter 124 can have an inner diameter of about 0.035 inches, and guidewire 27 can have an outer diameter of about 0.018 inches. In another example, catheter 31 can have an inner diameter of approximately 0.088 inches, catheter 120 can have an inner diameter of approximately 0.071 inches, catheter 124 can have an inner diameter of approximately 0.045 inches, and guidewire 27 can have an outer diameter of approximately 0.018 inches.

[0038] In one commercial implementation, a pre-assembled access assembly (guide catheter, access catheter, and guidewire) can be carried in a first channel on the sterile barrier tray, and a pre-assembled treatment assembly (one or two treatment catheters and guidewire) can be carried in the same or a different second channel on the sterile barrier tray. One, two, or more additional catheters or interventional tools can also be provided, depending on potential needs during the interventional procedure.

[0039] 3G-3K illustrate an alternative sterility barrier embodiment having a convex drive surface (e.g., a convex crowned road drive surface). FIG. 3G is a cross-sectional view of sterility barrier 232. Sterility barrier 232 includes a convex upper support surface 204. Fluid channels 205 and 207 are positioned laterally and below support surface 204 for self-clearing or draining fluid from support surface 204 (e.g., during an interventional procedure). Fluid channels 205 and 207 can extend axially for at least a portion of the length of the sterility barrier.

[0040] 3I, 3J, and 3K illustrate a cross-sectional perspective view, a cross-sectional view, and a top cross-sectional view, respectively, of the proximal end of sterility barrier 232. As shown in FIGS. 3I-3K, sterility barrier 232 can include a trough 240 in communication with fluid channels 205 and 207. Trough 240 can receive fluid from channels 205 and 207 (e.g., during an interventional procedure). Trough 240 can be positioned at least partially below fluid channels 205 and 207 such that fluid in channels 205 and 207 flows into trough 240. In certain embodiments, fluid channels 205 and 207 can be angled relative to a horizontal plane (e.g., can descend from the end of the channel farthest from trough 240 into trough 240) such that fluid in channels 205 and 207 is directed toward trough 240. For example, channels 205 and 207 can increase in depth from the ends of the channels farthest from trough 240 to trough 240. Alternatively, sterility barrier 232 and / or support table can be positioned at an angle relative to a horizontal plane during part or all of the interventional procedure, such that the ends of channels 205 and 207 farthest from trough 240 are positioned higher than trough 240. For example, sterility barrier 232 and / or support table can be constructed or positioned in an angled arrangement such that the ends of sterility barrier 232 and / or support table opposite trough 240 are positioned higher than trough 240. Alternatively or additionally, the drive mechanism may be capable of temporarily tilting the sterile barrier 232 and / or support table (e.g., by lifting the end of the sterile barrier and / or support table opposite the trough 240 or by lowering the end of the sterile barrier 232 and / or support table on which the trough 240 is positioned) so that the end of the sterile barrier 232 and / or support table opposite the trough 240 is positioned higher than the trough 240, allowing the fluid in the channels 205 and 207 to flow into the trough 240.

[0041] The trough 240 can include a drain hole 242. The trough 240 can be shaped, sized, and / or otherwise configured to allow fluid in the trough 240 to empty into the drain hole 242. The drain hole 242 can include tubing, a barb fitting, and / or an on-off valve for removal of fluid from the trough 240. As shown in FIGS. 3I-3K, the trough 240 can be positioned at the proximal end of the sterility barrier 232. In an alternative embodiment, the trough 240 can be positioned at the distal end of the sterility barrier 232. In some embodiments, the sterility barrier 232 can include a first trough 240 at the proximal end and a second trough 240 at the distal end. In some embodiments, the trough 240 can also be used as a washing reservoir.

[0042] The first channel 206 can extend axially for at least a portion of the length of the sterility barrier 232. The channel 206 can have a length sufficient to hold an interventional device and a width and depth sufficient to hold a corresponding hub (e.g., by providing support to prevent the hub from dislodging when force is applied to the hub). Optionally, a second channel 212 can be provided. The second channel 212 can be positioned on the same or opposite side of the upper support surface 204 from the first channel 206. FIG. 3G illustrates the channel 212 positioned on the opposite side of the support surface 204 from the channel 206. FIG. 3H is a cross-sectional view illustrating an alternative embodiment of the sterility barrier 232 in which the channel 212 is on the same side of the support surface 204 as the channel 206.

[0043] 3G and 3H, channels 206 and 212 can have a generally triangular, wedge-shaped, or otherwise angled cross-section to hold the hub at an angle relative to the horizontal plane. Holding the hub at an angle relative to the horizontal plane can allow for a smaller width of sterility barrier 232.

[0044] Two, three or more additional recesses, such as additional channels or wells, can be provided to hold additional medical devices or supplies that may be useful during the interventional procedure, as well as to collect fluids and act as washing reservoirs for the catheter and related devices.

[0045] In some embodiments, the sterility barrier 232 can include one or more structural ribs 236. The sterility barrier 232 can further include one or more frame support bosses 228 and 238.

[0046] In the embodiment of the sterility barrier 232 shown in FIG. 3G, the width x1 can be 14 inches wide, approximately 14 inches wide, between 12 inches and 16 inches wide, between 10 inches and 18 inches wide, or any other suitable width. In the embodiment of the sterility barrier 232 shown in FIG. 3H, the width x1 can be 15 inches wide, approximately 15 inches wide, between 13 inches and 17 inches wide, between 11 inches and 19 inches wide, or any other suitable width. The height y1 of the support surface 204 can be 0.125 inches high, approximately 0.125 inches high, between 0.1 inches and 0.15 inches high, or any other suitable height. In some embodiments, the support surface 204 can be recessed from the top surface 233 of the sterility barrier 232. The height y2 between the bottom and top surface 233 of support surface 204 can be 0.5 inches high, approximately 0.5 inches high, between 0.25 inches and 0.75 inches high, or any other suitable height. The width x2 from the lateral edge of channel 205 to the lateral edge of channel 207 can be 5 inches wide, approximately 5 inches wide, between 4 inches and 6 inches wide, or any other suitable width. The width x3 of support surface 204 can be 4 inches wide, approximately 4 inches wide, between 3 inches and 5 inches wide, or any other suitable width. The height y3 of channel 206 and / or channel 212 can be 1.5 inches high, approximately 1.5 inches high, between 1 inch and 2 inches high, or any other suitable height. The width x4 of channel 206 and / or channel 212 can be 3 inches wide, approximately 3 inches wide, between 2 inches and 4 inches wide, or any other suitable width. Channel 206 and / or channel 212 can be defined by an arc angle α of 90°, an arc angle α of approximately 90°, an arc angle α of between 80° and 100°, or any other suitable angle, and by a radius of curvature of 0.125 inches, a radius of curvature of approximately 0.125 inches, a radius of curvature between 0.1 inches and 0.15 inches, or any other suitable radius of curvature.In certain embodiments, an arc angle α of 90° or approximately 90° can be used to hold a hub having a rectangular or generally rectangular cross-section. Support surface 204 can be defined by a radius of curvature of 13 inches, approximately 13 inches, between 11 and 15 inches, or any other suitable radius of curvature. Channel 205 and / or channel 207 can be defined by a radius of curvature of 0.25 inches, approximately 0.25 inches, between 0.15 and 0.35 inches, or any other suitable radius of curvature.

[0047] 3L and 3M depict exemplary dimensions of a hub 250 that may be used with the sterility barrier 232 as shown in FIGS. 3G-3K. The hub 250 can be any of the hubs described herein. In certain embodiments, the hub 250 can have a width w1 of 3.75 inches, a width w1 of approximately 3.75 inches, a width w1 of between 3.25 inches and 4.25 inches, or any other suitable width. The hub 250 can have a height h1 of 1.5 inches, a height h1 of approximately 1.5 inches, a height h1 of between 1.25 inches and 1.75 inches, or any other suitable height. Alternatively, the hub 250 can have a height h2 of 2 inches, a height h2 of approximately 2 inches, a height h2 of between 1.75 inches and 2.25 inches, or any other suitable height. In some embodiments, the hub 250 can have a length L1 of 2.5 inches, a length L1 of approximately 2.5 inches, a length L1 of between 2 and 3 inches, or any other suitable length. Alternatively, the hub 250 can have a length L2 of 4 inches, a length L2 of approximately 4 inches, a length L2 of between 3.25 and 4.75 inches, or any other suitable length.

[0048] In some embodiments, the upper surface of the support table can include surface features that generally correspond to those of the sterility barrier 232. For example, the support table can include a convex surface configured to correspond to the shape, size, and location of the support surface 204 and / or one or more recesses configured to correspond to the shape, size, and location of the channels 205 and 207.

[0049] In alternative embodiments, the planar support surface (e.g., support surface 104 of sterility barrier 32) can be positioned at an angle relative to the horizontal plane to facilitate drainage of fluids. In some embodiments, the sterility barrier and / or support table can be positioned at an angle relative to the horizontal plane to facilitate drainage of fluids during part or all of an interventional procedure. For example, the sterility barrier and / or support table can be constructed or positioned in an angled arrangement to facilitate drainage of fluids (e.g., one lateral side of the planar support surface is positioned higher than the other lateral side of the planar support surface, the proximal end is higher than the distal end, or the distal end is higher than the proximal end). Alternatively or additionally, the drive mechanism may temporarily tilt the sterile barrier and / or support table (e.g., so that one lateral side of the planar support surface is positioned higher than the other lateral side of the planar support surface, so that the proximal end is higher than the distal end, or so that the distal end is higher than the proximal end) to facilitate fluid drainage. For example, the drive mechanism may raise or lower one lateral side of the sterile barrier and / or support table, the proximal end of the sterile barrier and / or support table, and / or the distal end of the sterile barrier and / or support table.

[0050] In certain embodiments, the support surface (e.g., support surface 104 of sterile barrier 32) can be positioned in a vertical configuration rather than the horizontal configuration shown in, for example, FIGS. 3A-3F. For example, support surface 104 can be positioned approximately 90 degrees (or any other suitable angle) from the horizontal plane (e.g., rotated 90 degrees about the long axis of support surface 104 relative to the embodiment shown in FIGS. 3A-3F). The vertical configuration can provide easier interaction with drive system 18 by the physician. The vertical configuration can also provide a lower axis of catheter travel closer to the patient without adding standoff height to drive system 18.

[0051] In some embodiments, drive system 18 can be positioned at an angle relative to a horizontal plane to facilitate fluid drainage during part or all of an interventional procedure. For example, drive system 18 can be constructed or positioned in an angled arrangement (e.g., one lateral side of the planar support surface is positioned higher than the other lateral side of the planar support surface, the proximal end is higher than the distal end, or the distal end is higher than the proximal end) to facilitate fluid drainage. Alternatively or additionally, the drive mechanism can temporarily tilt drive system 18 to facilitate fluid drainage (e.g., one lateral side of drive system 18 is positioned higher than the other lateral side of drive system 18, the proximal end is higher than the distal end, or the distal end is higher than the proximal end). For example, the drive mechanism can raise or lower one lateral side of the system 18, the proximal end of the drive system 18, and / or the distal end of the drive system 18. In some embodiments, the drive system 18 can be angled so that it extends at an angle away from the access point 24 (e.g., so that the proximal end is higher than the distal end), for example, to allow clearance for the patient's feet.

[0052] Referring to FIG. 4 , the hub 36 can represent any of the hubs previously described. The hub 36 includes a housing 38 extending between a proximal end 40 and a distal end 42. An interventional device 44 (which can be any of the interventional devices disclosed herein) extends distally from the hub 36 into the patient 14 (not shown). The hub adapter 48, or carriage, acts as a shuttle by advancing proximally or distally along a track in response to operator commands or controller manipulation. The hub adapter 48 includes at least one drive magnet 67 configured to couple with a driven magnet 69 carried by the hub 36. This provides a magnetic coupling between the drive magnet 67 and the driven magnet 69 through the sterile barrier such that the hub 36 is moved across the top of the sterile barrier 32 in response to movement of the hub adapter 48 outside the sterile field. Movement of the hub adapter is driven by a drive system carried by the support table and described in additional detail below. The hub adapter is capable of acting as a robotic drive for an interventional device coupled to it.

[0053] To reduce friction within the system, the hub 36 can be provided with at least a first roller 53 and a second roller 55, which can be in the form of a wheel, a rotatable ball, or a drum. The rollers space the sterility barrier from the surface of the driven magnet 69 by at least about 0.008 inches, and typically about 0.03 inches or less. In some implementations, the space is within a range of about 0.010 inches to about 0.016 inches. The space between the drive magnet 67 and the driven magnet 69 is typically about 0.15 inches or less, and in some implementations, about 0.10 inches or less, such as within a range of about 0.085 inches to about 0.090 inches. The hub adapter 48 may likewise be provided with at least a first hub adapter roller 59 and a second hub adapter roller 63, which may be positioned opposite the respective first roller 53 and second roller 55, as shown in FIG. 4.

[0054] 6, one example of a low-profile linear drive support table 20 is illustrated schematically. The support table 20 includes an elongated frame 51 extending between a proximal end 52 and a distal end 54. At least one support table support 56 is provided for stabilizing the support table 20 relative to a patient (not shown). The support 56 may include one or more legs, or preferably, articulating arms, that are configured to allow movement and positioning of the frame 51 on or adjacent to the patient.

[0055] One example of the linear drive table 20 shown in FIG. 7 includes three individual drives. However, two drives or four or more drives (e.g., up to eight drives) can be included depending on the desired clinical performance. A first drive pulley 58 is engaged with a first drive belt 60. A first carriage bracket 61 is fixed to the first drive belt 60 such that rotation of the first drive pulley 58 causes rotation of the first drive belt 60 through an elongated closed-loop path. The first carriage bracket 61 can be advanced proximally or distally along the longitudinal axis of the support table 20 depending on the direction of rotation of the drive pulley 58. In the illustrated implementation, the drive pulley 58 is provided with surface structure, such as a plurality of drive pulley teeth 62, for engaging complementary teeth on the first drive belt 60.

[0056] The second drive pulley 64 can be engaged with a second drive belt 66, which is configured to axially move a second carriage bracket 68 along an axial path over the support table 20. The third drive pulley 70 can be configured to drive a third drive belt 72 to axially advance a third carriage bracket 73 along the support table 20. Each of the carriage brackets can be provided with a drive magnet assembly, not shown in FIG. 7 but previously discussed, to form a coupler for magnetically coupling to a corresponding driven magnet in the hub of an interventional device as discussed.

[0057] A detailed view of the drive system is shown schematically in FIG. 8 . A drive support 74 can be carried by the frame 51 for supporting the drive assembly. The second drive pulley 64 is shown in elevational section as being rotationally driven by a motor 75 via a rotatable shaft 76. The rotatable shaft 76 can be rotatably carried by the support 74 via a first bearing 78, a shaft coupling 80, and a second bearing 79. The motor 75 can be stabilized by a motor bracket 82 connected to the drive support 74 and / or the frame 51. The belt drive assemblies for the first drive belt 60 and the third drive belt 72 can be similarly constructed and will not be further detailed herein. In some embodiments, the drive system described herein can be a foldable rack-and-pinion drive table system. In such embodiments, the motor 75 can be attached to the carriage and move with the carriage.

[0058] 9 and 10, each of the first, second, and third drive belts extends around a corresponding first idler pulley 84, a second idler pulley 86, and a third idler pulley 88. Each idler pulley may be provided with a corresponding tensioning bracket 90 configured to adjust the idler pulley proximally or distally to adjust the tension of the respective belt. Accordingly, each tensioning bracket 90 is provided with a tensioning adjustment portion 92, such as a rotatable screw or the like.

[0059] As seen in FIG. 10, the second idler pulley 86 may be carried, for example, by a rotatable shaft 94 that is rotatably fixed relative to the mounting bracket by a first bearing 96 and a second bearing 98.

[0060] For example, any of the catheters illustrated in Figures 5A, 5B, or 11 generally include an elongated tubular body extending between a proximal end and a distal working end. The length and diameter of the tubular body depend on the desired application. For example, lengths in the area of ​​about 90 centimeters to about 195 centimeters or more are typical for use in percutaneous transluminal coronary applications with femoral access. Intracranial or other applications may require different catheter shaft lengths depending on the vascular access site.

[0061] Any of the catheters disclosed herein can be provided with a beveled distal tip. Referring to Figure 11, a distal catheter tip 1150 includes a tubular body 1152, which includes an advancement segment 1154, a marker band 1156, and a proximal segment 1158. An inner tubular liner 1160 can extend throughout the length of the distal catheter tip 1150 and can include dip-coated or extruded PTFE or other lubricious material.

[0062] A reinforcing element 1162, such as a braid and / or spring coils, is embedded within an outer jacket 1164, which may extend the entire length of the catheter.

[0063] The advancing segment 1154 terminates distally in an angled surface 1166 and provides a leading sidewall portion 1168 having a length measured between the distal end 130 of the marker band 1156 and a distal tip 1172. In some embodiments, the entire distal tip can be shaped to avoid snagging of the tip in the area of ​​an arterial bifurcation. The trailing sidewall portion 1174 of the advancing segment 1154 has an axial length that, in the illustrated embodiment, is approximately equal to the axial length of the leading sidewall portion 1168 as measured approximately 180 degrees around the catheter from the leading sidewall portion 1168. The leading sidewall portion 1168 can have an axial length in the range of about 0.1 millimeter to about 5 millimeters, and typically in the range of about 1 millimeter to 3 millimeters. The trailing sidewall portion 1174 can be equal to or at least about 0.1 or 0.5 or 1 millimeter or 2 millimeters or more shorter than the axial length of the leading sidewall portion 1168 depending on the desired performance.

[0064] The angled surface 1166 is inclined at an angle A ranging from about 45 degrees to about 80 degrees from the longitudinal axis of the catheter. For certain implementations, the angle is ranging from about 55 degrees to about 65 degrees from the longitudinal axis of the catheter. In one implementation, angle A is about 60 degrees. One result of an angle A less than 90 degrees is that the major axis of the distal port area is lengthened, which can increase the surface area of ​​the port and enhance clot aspiration or retention. Compared to the surface area of ​​a circular port (where angle A is 90 degrees), the area of ​​the angled port is generally at least about 105 percent and not more than about 130 percent, and in some implementations, is in the range of about 110 percent to about 125 percent, and in one example, is about 115 percent of the area of ​​the corresponding circular port (where angle A is 90 degrees).

[0065] In the illustrated embodiment, the axial length of the advancement segment is substantially constant around the circumference of the catheter, such that the angled surface 1166 is approximately parallel to the distal surface 1176 of the marker band 1156. The marker band 1156 has a proximal surface that is approximately transverse to the longitudinal axis of the catheter, creating a right-angled trapezoidal configuration for the marker band 1156 in side view. The short sidewall portion 1178 is rotationally aligned with the trailing sidewall portion 1174 and has an axial length in the range of about 0.2 millimeters to about 4 millimeters, with an axial length of about 0.5 millimeters to about 2 millimeters being typical. The opposing long sidewall portion 1180 is rotationally aligned with the leading sidewall portion 1168. The long sidewall 1180 of the marker band 1156 is generally at least about 10 or 20 percent longer than the short sidewall 1178, and depending on the desired performance, can be at least about 50, 70, or 90 percent or more longer than the short sidewall 1178. Generally, the long sidewall 1180 will have a length of at least about 0.5 millimeters or 1 millimeter and less than about 5 millimeters or less than 4 millimeters.

[0066] The marker band can be a continuous annular structure or can have at least one, and optionally two or three or more, axially extending slits throughout its length. The slits can be located on or between the short sidewall 1178 or the long sidewall 1180 depending on the desired bending characteristics. The marker band can comprise any of a variety of radiopaque materials, such as a platinum / iridium alloy, and the wall thickness is preferably about 0.003 inches or less, and in one implementation, about 0.001 inches.

[0067] The fluoroscopic appearance of the marker bands can be unique or individual for each catheter size or type when multiple catheters are utilized, such that the marker bands can be distinguishable from one another by a software algorithm. Distinguishing the marker bands of multiple catheters can be advantageous when multiple catheters are used together, for example, in a multi-catheter assembly or stack as described herein. In some embodiments, the marker bands of the catheters can be configured to allow a software algorithm to detect catheter tip movement.

[0068] The marker band zone of the assembled catheter can have a relatively high bending stiffness and high crush strength (e.g., at least about 50 percent or at least about 100 percent less than the proximal segment 1158, but not more than about 200 percent less than the proximal segment 1158). The high crush strength can provide radial support to the adjacent advancement segment 1154, particularly the leading sidewall portion 1168, and promote the distal tip 1172 to function as an atraumatic bumper during transluminal advancement and resist collapse under vacuum. The proximal segment 1158 preferably has a lower bending stiffness than the marker band zone, and the advancement segment 1154 preferably has an even lower bending stiffness and crush strength than the proximal segment 1158.

[0069] The advancement segment 1154 can include a distal extension of an outer tubular jacket 1164 and optionally an inner liner 1160 without any other internal support structure distal to the marker band 1156. The outer jacket 1164 can include an extruded polyurethane such as Tecothane® or NEUsoft™. The advancement segment 1154 can have a bending stiffness and radial crush stiffness that are about 50 percent or less, and in some implementations about 25 percent or less, 15 percent or less, or 5 percent or less, than the corresponding values ​​of the proximal segment 1158.

[0070] The catheter can further include an axial tension element or support, such as a ribbon or one or more filaments or fibers, to increase tension resistance and / or affect bending characteristics in the distal zone. The tension support can include one or more axially extending monostrand or multistrand filaments. One or more tension elements 1182 can be axially positioned inside the catheter wall near the distal end of the catheter. The one or more tension elements 1182 can function as tension supports and resist tip dislodgement or stretching of the catheter wall under tension (e.g., when the catheter is retracted proximally through a kinked outer catheter or tortuous or narrowed vasculature).

[0071] At least one of the one or more tension elements 1182 can extend proximally along the length of the catheter wall from within about 1.0 centimeter of the distal end of the catheter, to less than about 10 centimeters from the distal end of the catheter, to less than about 20 centimeters from the distal end of the catheter, to less than about 30 centimeters from the distal end of the catheter, to less than about 40 centimeters from the distal end of the catheter, or to less than about 50 centimeters from the distal end of the catheter.

[0072] One or more tension elements 1182 can have a length greater than or equal to about 40 centimeters, greater than or equal to about 30 centimeters, greater than or equal to about 20 centimeters, greater than or equal to about 10 centimeters, or greater than or equal to about 5 centimeters.

[0073] At least one of the one or more tension elements 1182 can extend over at least about the most distal 50 centimeters of the length of the catheter, at least about the most distal 40 centimeters of the length of the catheter, at least about the most distal 30 centimeters, or 20 centimeters, or 10 centimeters of the length of the catheter.

[0074] In some implementations, the tension element extends proximally from the distal end of the catheter along the length of the coil 24, terminating proximally within about 5 centimeters or 2 centimeters or less on either side of the transition between the distal coil and the proximal braid. The tension element can terminate at the transition without overlapping the braid.

[0075] One or more tension elements 1182 can be located near or radially outside the inner liner 1160. One or more tension elements 1182 can be located near or radially inside the braid and / or coil. One or more tension elements 1182 can be carried between the inner liner 1160 and the helical coil and can be secured to the surface of the inner liner or other underlying layer by adhesive before the addition of the next outer adjacent layer, such as a coil. Preferably, the tension elements 1182 are secured to the marker band 1156 by adhesive or mechanical interference. In one implementation, the tension elements 1182 extend distally over and beyond the marker band on a first (e.g., inner) surface of the marker band, then wrap around the distal end of the marker band, extend along a second (e.g., outer) surface in either a proximal angled direction or a circumferential direction, or both, and completely wrap around the marker band.

[0076] When two or more tension elements 1182 or filament bundles are circumferentially spaced apart within the catheter wall, the tension elements 1182 can be positioned in a radially symmetric manner. For example, the angle between two tension elements 1182 relative to the radial center of the catheter can be approximately 180 degrees. Alternatively, depending on the desired clinical performance (e.g., flexibility, trackability), the tension elements 1182 can be positioned in a radially asymmetric manner. The angle between any two tension elements 1182 relative to the radial center of the catheter can be less than or equal to approximately 180 degrees, less than or equal to approximately 165 degrees, less than or equal to approximately 135 degrees, less than or equal to approximately 120 degrees, less than or equal to approximately 90 degrees, less than or equal to approximately 45 degrees, or less than or equal to approximately 15 degrees.

[0077] The one or more tension elements 1182 can comprise materials such as Vectran®, Kevlar®, Polyester®, Spectra®, Dyneema®, Meta-Para-Aramide®, or any combination thereof. At least one of the one or more tension elements 1182 can comprise a single fiber or a multi-fiber bundle, and the fiber or bundle can have a round or rectangular (e.g., ribbon) cross-section. The terms fiber or filament do not convey composition; they can comprise any of a variety of high tensile strength polymers, metals, or alloys, depending on design considerations such as the desired tensile fracture limit and wall thickness. The cross-sectional dimension of the one or more tension elements 1182, as measured radially, can be approximately 2 percent or less, 5 percent or less, 8 percent or less, 15 percent or less, or 20 percent or less of that of the catheter 10.

[0078] The cross-sectional dimension of one or more tension elements 1182, as measured radially, can be about 0.03 millimeters (about 0.001 inches) or less, about 0.0508 millimeters (about 0.002 inches) or less, about 0.1 millimeters (about 0.004 inches) or less, about 0.15 millimeters (about 0.006 inches) or less, about 0.2 millimeters (about 0.008 inches) or less, or about 0.38 millimeters (about 0.015 inches) or less.

[0079] The one or more tensioning elements 1182 can increase the tensile strength of the distal zone of the catheter before failure under tension (e.g., marker band detachment) to at least about 1 lb, at least about 2 lb, at least about 3 lb, at least about 4 lb, at least about 5 lb, at least about 6 lb, at least about 7 lb, at least about 8 lb, or at least about 10 lb or more.

[0080] Depending on the desired data, any of a variety of sensors can be provided on either the catheter, hub, carriage, or table. For example, in some implementations, it may be desirable to measure axial tension or compression applied to the catheter, such as along a force-sensing zone. The distal end of the catheter would be made of a similar construction as shown in FIG. 11 with a helical coil distal section. However, instead of using a single helical coil of nitinol wire, first conductor 140 and second conductor 142 are wound into intertwined helical coils and are electrically isolated from each other, for example, by the plastic / resin of the tubular body. See FIG. 12A. Each coil is in electrical communication with the proximal hub by a unique electrical conductor, such as a conductive trace or a proximal extension of the wire.

[0081] This construction of dual, electrically isolated helical coils creates a capacitor, roughly equivalent to two plates of Nitinol with a plastic layer between them, as shown in FIG. 12B. Capacitance is inversely proportional to the distance between the wires. The only variable that will vary is d (the distance between the plates). When an axial compressive force is applied to the catheter, the wires (e.g., conductors 140 and 142) will move closer together, thus increasing the capacitance. When an axial tensile force is applied, the wires will move further apart, decreasing the capacitance. This capacitance can be measured at the proximal end of the catheter, providing a measure of the force on the helical capacitor. Although called a capacitor, the sensor is measuring the electrical interaction between the two coils of wire. There can be a measurable change in inductance or other resulting change due to the applied axial force.

[0082] At least a first helical capacitor can have at least one, five, ten, or more complete turns of each wire. The capacitor can be positioned within the distal-most 5, 10, or 20 centimeters of the catheter body to sense forces experienced at the distal end. At least a second capacitor can be provided within the proximal-most 5, 10, or 20 centimeters of the catheter body to sense forces experienced at the proximal end of the catheter.

[0083] It may also be desirable to measure the elastic force across the magnetic linkage between the hub and the corresponding carriage, using the magnetic linkage's natural springiness (compliance) to measure the force applied to the hub. The magnetic linkage between the hub and carriage creates a spring. When a force is applied to the hub, the hub will move a small amount relative to the carriage. See FIG. 13A. In robotics, this is called a series elastic actuator. This property can be used to measure the force applied to the hub from the carriage. To measure the force, the relative distance between the hub and carriage (dx shown in FIG. 13A) is determined to characterize some effective spring constant k between the two components. See FIG. 13B.

[0084] Relative distance can be measured in several different ways. One method for measuring the relative distance between the hub and carriage is with a magnetic sensor (e.g., a Hall effect sensor between the hub and carriage). A magnet is mounted on either the hub or the carriage, and a corresponding magnetic sensor is mounted on the other device (carriage or hub). The magnetic sensor can be a Hall effect sensor, a magnetoresistive sensor, or another type of magnetic field sensor. Generally, multiple sensors can be used to increase the reliability of the measurement. This reduces noise and reduces interference from external magnetic fields.

[0085] Other non-contact distance sensors can also be used. These include optical, inductive, and capacitive sensors. Optical sensors would preferably be configured in a manner that avoids the accumulation of blood or other fluids at the interface between the hub and the carriage. In some implementations, for example, wireless (i.e., inductive) power can be used to transduce movement and / or transfer information across the sterile barrier between the drive carriage and the hub.

[0086] The magnetic coupling between the hub and carriage has a shear or axial break threshold, which can be approximately 300 grams or 1000 grams or more. The processor can be configured to compare the axial force applied to the catheter to a preset axial trigger force that, if applied to the catheter, is perceived to create a risk to the patient. If the trigger force is reached, the processor can be configured to generate a response, such as visual, auditory, or tactile feedback to the physician, and / or to slow and stop further advancement of the catheter until a reset is achieved. An override feature can be provided so that the physician can choose to continue advancing the catheter at a force higher than the trigger force in situations where the physician believes incremental force is justified.

[0087] Force and / or torque sensing optical fibers (e.g., fiber Bragg grating (FBG) sensors) can be incorporated into the catheter sidewall or, alternatively, integrated into the guidewire to measure force and / or torque at various locations along the catheter shaft. The fiber measures axial strain, which (when helically wound) can be converted to axial force or torque. At least a first FBG sensor can be integrated into a distal, proximal, and / or intermediate sensing zone on the catheter or guidewire to measure force and / or torque in the vicinity of the sensor.

[0088] It may also be desirable to understand the three-dimensional configuration of a catheter or guidewire during and / or following transvascular placement. Shape-sensing optical fibers, such as arrays of FBG fibers, are used to sense the shape of catheters and guidewires. By using multiple force-sensing fibers at known distances from each other, the shape along the length of the catheter / guidewire can be determined.

[0089] Strain gauges can be integrated into the body of the catheter or guidewire to measure force or torque. In one example, the strain gauges are resistive strain gauges. In some embodiments, strain gauges are incorporated into the distal tip of the catheter, or into the proximal end of the catheter, and / or into the proximal end of the catheter. In some embodiments, strain gauges can be deposited on the wall of the catheter via thin film deposition techniques.

[0090] Measurements of the force and / or torque applied to the catheter or guidewire shaft can be used to determine applied force and / or torque above a safety threshold. A warning can be provided to the user when the applied force and / or torque exceeds the safety threshold. Measurements of the applied force and / or torque can also be used to provide feedback related to better catheter manipulation and control. Measurements of the applied force and / or torque can also be used in conjunction with processed fluoroscopic imaging information to determine or characterize distal tip motion.

[0091] The absolute position of the hub (and corresponding catheter) along the length of the table can be determined in a variety of ways. For example, a non-contact magnetic sensor can be configured to measure the position of the hub directly through the sterile barrier. The same type of sensor can also be configured to measure the position of the carriage. Each hub can have at least one magnet attached to it. The robotic table will have a corresponding linear array of magnetic sensors spanning the length of the table. A processor can be configured to determine the location of the magnet along the length of the linear sensor array and display the axial position information to the physician.

[0092] Alternatively, the foregoing can be accomplished using non-contact inductive sensors to directly measure the position of the hub through the sterile barrier. Each hub or carriage can be provided with an inductive "target" therein. The robot table can be provided with an inductive sensing array throughout the working length of the table. As a further alternative, an absolute linear encoder can be used to directly measure the linear position of the hub or carriage. The encoder can use any of a variety of different technologies, including optical, magnetic, inductive, and capacitive methods.

[0093] In one implementation, a passive (no electrical connection) target coil can be carried by each hub. A linear printed circuit board (PCB) can run the entire working length of the table (e.g., at least about 1.5 meters to about 1.9 meters) configured to ping an interrogator signal that stimulates a return signal from the passive coil. The PCB is configured to identify the return signal and its location.

[0094] The axial position of the carriage can be determined using a multi-turn rotary encoder to measure the rotational position of the pulley, which directly correlates to the linear position of the carriage. Direct measurement of the carriage location can alternatively be achieved by recording the number of steps commanded to a stepper motor to measure the rotational position of the pulley, which directly correlates to the linear position of the carriage.

[0095] The location of the catheter and guidewire within the anatomy can also be determined by processing fluoroscopic images with machine vision to, for example, determine distal tip position, distal tip orientation, and / or guidewire shape. Comparing distal tip position or movement, or lack thereof, to commanded or actual proximal catheter or guidewire movement at the hub can be used to detect loss of relative motion, which can indicate device shaft buckling, prolapse, kinking, or similar consequences (e.g., along the device shaft length inside the body (e.g., in the aorta) or outside the body between the hubs). Processing can be done in real time to provide position / orientation data at up to 30 Hz, although this technique will only provide data while fluoroscopic imaging is turned on. In some embodiments, similar to driver assistance, machine vision algorithms can be used to generate and suggest optimal catheter maneuvers to access or reach anatomical landmarks. Machine vision algorithms can utilize the data to automatically navigate the catheter according to the anatomy presented by fluoroscopy. Machine vision can also be used to analyze catheter straightness in response to increased tension. As tension increases in the catheter due to navigating anatomical tortuosity, the catheter begins to yield and buckle in a sinusoidal manner, thus becoming less straight. This increased tension, if increased sufficiently, can lead to more severe prolapse. Measuring the loss of straightness can be a signal to stop before prolapse can occur. This can be particularly useful when the area of ​​prolapse is outside the current X-ray field of view.

[0096] The proximal torque applied to a catheter or guidewire shaft can be determined using a dual-encoder torque sensor. Referring to FIG. 14, a first encoder 144 and a second encoder 146 can be spaced axially along a shaft 148 to measure the difference in angle over the length of a flexible catheter / tube. The difference in angle is interpolated as torque because the catheter / tube has a known torsional stiffness. When torque is applied to the shaft, the slightly flexible portion of the shaft will twist. The difference between the angles measured by the encoders (dθ) gives the torque: T=k*dθ, where k is the torsional stiffness.

[0097] Ensuring the absence of bubbles in the fluid line can also be achieved using a bubble sensor, especially when the physician is remote from the patient. This can be achieved using a non-contact ultrasonic sensor that measures the intensity and Doppler shift of reflected ultrasound through the sidewall of the fluid tubing to detect bubbles and measure fluid flow rate or level. An ultrasonic or optical sensor can be positioned adjacent to the inflow fluid flow path in the hub or in the supply line leading to the hub. To detect the presence of air bubbles in an infusion line (which is formed from an ultrasonically or optically transparent material), the sensor can include a signal source on a first side of the flow path and a receiver on a second side of the flow path to measure transmission through the liquid passing through the tubing to detect bubbles. Alternatively, the reflected ultrasound signal can be detected from the same side of the flow path as the source due to the relatively high echogenicity of bubbles.

[0098] Preferably, the bubble removal system is automatically activated upon detection of an in-line bubble. The processor can be configured to activate a valve positioned in the flow path downstream of the bubble detector upon detection of a bubble. The valve diverts the column of fluid from the flow path to the patient into the reservoir. Once bubbles are no longer detected in the flow path, and after 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 source of fluid to the patient through the flow path. In some embodiments, bubbles can be removed from the catheter wall via beamed ultrasonic energy from an ultrasound transducer. In other embodiments, the bubble removal system can include a pump and control system upstream of the bubble detector for removal of in-line bubbles. The processor can be configured to activate the pump upon detection of a bubble to reverse fluid flow and remove the bubble into a waste reservoir before reestablishing forward, bubble-free flow.

[0099] Additionally, it may be desirable for the physician to be able to view the aspirated clot at a predetermined location within the sterile field, and preferably as close to the patient as practical for fluid management purposes. This can be accomplished by providing a clot retrieval device mounted on the hub or mounted in the aspiration line leading away from the hub toward the pump. Referring to FIG. 15 , one example of a clot retrieval device 370 can include a body portion 380 enclosing a chamber 381 that communicates with a first port 310 and a second port 320.

[0100] In some embodiments, body 380 includes a housing having a top portion 382 and a bottom portion 384. Body 380 can include filter 330, which is positioned within chamber 381 between top portion 382 and bottom portion 384. In some examples, first port 310 is configured to connect to a first end of first tubing 340, which is fluidly connected to the proximal end of the suction catheter.

[0101] In embodiments configured to be connected downstream from a hub, first tube 340 includes connector 342 positioned at a second end of first tube 340 that is configured to engage or mate with a corresponding connector on or in communication with the hub. First port 310 is in direct communication with the chamber upstream (e.g., top side) of the filter, and second port 320 is in direct communication with the chamber downstream (e.g., bottom side) of the filter, facilitating direct visualization of captured material on the upstream side of the filter.

[0102] In implementations configured for remote operation, any of a variety of sensors may be provided to detect clots passing through the aspiration line and / or trapped in the filter, such as, for example, optical sensors, pressure sensors, flow sensors, ultrasonic sensors, or others known in the art.

[0103] In some embodiments, the second port 320 is configured to connect to a first end of a second tube 350 that is fluidly connected to a suction source (e.g., a pump). In some embodiments, the second tube 350 includes a connector 352 positioned at the second end of the second tube 350 that is configured to engage or mate with a corresponding connector on the pump.

[0104] In some examples, system 300 can include an on-off valve 360, such as clamp 360. Clamp 360 can be positioned between filter 330 and the patient (e.g., on first tube 340) to allow a user to engage the clamp and to provide flow control by isolating the patient from clot retrieval device 370. Closing valve 360 ​​and operating a remote vacuum pump (not shown) causes the vacuum pump and a canister associated with chamber 381 to reach the same low pressure. Due to the short lumen distance and small line volume between chamber 381 and the distal end of the catheter, a sharp negative pressure spike is experienced at the distal end of the catheter quickly following the opening of valve 360. Additional details are disclosed in U.S. Patent No. 11,259,821, entitled "Aspiration System with Accelerated Response," issued March 1, 2022 to Buck et al., the entire contents of which are expressly incorporated herein by reference. In some embodiments, a vacuum can be circulated over the clot to retrieve it. The vacuum can be automatically and robotically controlled to remove the clot.

[0105] The body portion 380 can have a top surface spaced apart from a bottom surface by a tubular sidewall. In the illustrated implementation, the top and bottom surfaces are substantially circular and spaced apart by a cylindrical sidewall. The top surface can have a diameter at least about three or five or more times the axial length (transverse to the top and bottom surfaces) of the sidewall to create a generally disk-shaped housing. Preferably, at least a portion of the top wall is optically transparent to improve clot visualization once the clot is trapped within the clot retrieval device 370. Additional details can be found in PCT / US2022 / 078113, filed October 14, 2022, the entire contents of which are incorporated herein by reference.

[0106] In some examples, the main body portion 380 can include a flush port (not shown) configured to allow injection of an optically transparent medium (e.g., air, saline, or other fluid) into the chamber 381 to clear the optical path between the window and the filter for improved clot visualization once the clot is trapped in the filter 330.

[0107] The foregoing represent certain specific implementations of drive tables and associated components and catheters. As those skilled in the art will recognize in light of the disclosure herein, a wide variety of different drive table configurations can be made to support and axially advance and retract two, three, four, or more drive magnet assemblies for robotically driving interventional devices, fluidic elements, and electrical umbilical elements for transmitting electrical signals and fluids to the catheter hub. Additional details can be found in U.S. Patent Application Serial No. 17 / 527,393, filed November 16, 2021, which is incorporated herein by reference in its entirety.

[0108] Although the foregoing describes robotically driven and manually driven interventional devices, the devices can be manually driven, robotically driven, or a combination of both manually and robotically driven interventional devices, as will be recognized by those skilled in the art in light of the disclosure herein.

[0109] 16A-16C illustrate an exemplary control mechanism 2200 for manipulating an interventional device driven by (or otherwise associated with) a respective hub. For example, each hub can be manipulated and / or otherwise moved using at least one controller located within the control mechanism 2200. Each controller can be adapted to move its own hub and associated interventional device during an interventional procedure.

[0110] 16A, the control mechanism 2200 includes a first control unit 2202, a second control unit 2204, a third control unit 2206, and a fourth control unit 2208. More or fewer controls may be provided depending on the intended interventional device configuration. Each control unit 2202-2208 is movably carried on a shaft 2210, which is coupled to a distal bracket 2212 and a proximal bracket 2214. The control units 2202-2208 may be advanced distally or retracted proximally on the shaft 2210, as indicated by arrow 2218 and arrow 2216. Additionally, each control unit 2202-2208 may also be rotated about the shaft 2210, as indicated by arrow 2220. Movement of each control can trigger a responsive movement in a corresponding carriage on the support table, which can drive movement of a corresponding hub, as discussed above.

[0111] The control mechanism 2200 can be positioned on or near a patient support table with a set of hubs and catheter / interventional devices. In some implementations, the control mechanism 2200 can be positioned remotely from the support table, such as behind a radiation shield in a telemedicine implementation, or in a different room or geographic location.

[0112] Each controller 2202-2208 can correspond to and drive the movement of a hub and / or a hub and interventional device combination. For example, controller 2202 can be configured to drive hub 30 (FIG. 3F) to move an interventional device, such as a 0.088-inch guide catheter, corresponding to hub 30. Similarly, controller 2204 can be configured to drive hub 28 (122) to move an interventional device, such as a 0.071-inch treatment catheter. Controller 2206 can be configured to drive hub 126 to move an interventional device, such as a steerable access catheter. Controller 2208 can be configured to drive hub 26 to move an interventional device, such as a guidewire, axially and rotationally.

[0113] 16B illustrates an example of manually manipulating the control 2202 on the control mechanism 2200. In operation, when the user 2230 moves the control 2202 axially and distally along the shaft 2210, as indicated by arrow 2232, the corresponding coupled hub and / or interventional device can responsively move in the same direction by the same or scaled amount. When the user 2230 rotates the control 2202 about the shaft 2210 and advances the control proximally, as indicated by arrow 2234, the corresponding coupled interventional device will responsively move rotationally and proximally by the same or scaled amount. When the user 2230 moves the control 2202 rotationally about the shaft 2210, as indicated by arrow 2236 or arrow 2238, the corresponding coupled hub will rotationally drive the corresponding interventional device in the same direction and / or by the same or scaled amount.

[0114] Other axes and degrees of freedom can be defined to enable the control unit 2202 to perform movements that can be translated into movements of the hub and / or interventional device. For example, the control mechanism can be provided with one or more deflection controls configured to initiate lateral deflection within a deflection zone on a corresponding interventional device.

[0115] Axial movement of the control can be configured to move the coupled hub on a 1:1 basis or on a non-1:1 scaled basis. For example, if the user 2230 advances the control 2022 distally along the shaft 2210 approximately 5 millimeters, the corresponding hub can move distally 5 millimeters in response.

[0116] If the user 2230 rotates the control 2022 by 5 degrees about its axis of rotation, the coupled hub will rotate the corresponding interventional device on a 1:1 basis or on a non-1:1 scaled basis. The scaled amount can be selected to reduce or increase the distance and amount of rotation that the hub and / or interventional device travels in accordance with the control movement.

[0117] In some implementations, the scaled amounts described herein can be determined using a scale factor. The scale factor can be applied to one or both of the translational and rotational movements. In some implementations, a first scale factor is selected for the translational movement, and a second scale factor, different from the first scale factor, is selected for the rotational movement. The axial scaling factor can drive proximal catheter movement at a faster rate than distal catheter movement for a given proximal or distal manipulation of the control.

[0118] The rotational scale factor can be 1:1, while the axial scale factor can move the hub a greater distance than the control travel, such that the hub travel to control travel ratio is at least about 2:1, or 5:1, or 10:1, or more, depending on the desired axial length of the control assembly.

[0119] The control mechanism 2200 can be configured to allow the clinician to adjust the scale factor for different parts of the procedure. For example, distal advancement of the treatment catheter and access catheter through the guide catheter and to the selected ostium can preferably be achieved in a "fast" mode, while more distal travel into the neurovasculature can preferably be achieved in a slower mode by actuation of the speed control.

[0120] In another implementation, one or more controls can be configured to incrementally drive the advancement or retraction rate of a corresponding hub and associated catheter. For example, the distal control 2202 can drive a guide catheter. Small distal movements of the control 2202 can advance the guide catheter distally at a slow rate, while advancing the control 2202 distally a greater distance increases the rate of distal travel of the guide catheter.

[0121] Controlling the speed of the corresponding hubs, either axially or both axially and rotationally, can enhance the overall speed of the procedure. For example, advancement of various devices from the femoral access point to the aortic arch can desirably be achieved at a faster rate than more distal navigation closer to the treatment site. Also, proximal retraction of various devices (guidewires, access catheters, and treatment catheters, among others) can desirably be achieved at a relatively higher rate than distal advancement.

[0122] FIG. 16C illustrates another example of manually manipulating controls on the control mechanism 2200 to move a hub and / or other interventional devices. In some implementations, two or more controls 2202-2208 can be moved in combination to trigger movement of one or more hubs and / or associated interventional devices. In the depicted example, the user 2230 moves the control unit 2204 and the control unit 2206 in combination (e.g., sequentially, simultaneously), such as to simultaneously move a 0.088 guide catheter and a 0.071 suction catheter as a unit. Exemplary movement of the control unit 2204 can include axial proximal movement in the direction indicated by arrow 2250. Sequentially or simultaneously, the user 2230 can move the control unit 2206 axially in either of the directions indicated by arrows 2254 and 2256 and simultaneously move the control unit 2206 rotationally in either of the directions indicated by arrows 2258 and 2260.

[0123] In some implementations, each control mechanism and / or additional controls (not shown) can be color-coded, shape-coded, tactilely coded, or otherwise coded to indicate to the user 2230 which color is configured to move which hub or interventional device. In some implementations, the color coding of the controls can also be applied to the hub and / or interventional device, allowing the user to visually match a particular hub / device with a particular control.

[0124] In some implementations, control operations other than translational and rotational movements can be performed using the controllers 2202-2208. For example, the controllers 2202-2208 can be configured to drive shape and / or stiffness changes of the corresponding interventional device. The controllers 2202-2208 can be switched between different operating modes. For example, the controllers 2202-2208 can be switched between movements driven by acceleration and velocity and movements reflecting actual linear displacement or rotation.

[0125] In some implementations, the control mechanism 2200 can be provided with a visual display or other indicator of the relative position of the controls, which can correspond to the relative position of the interventional device. Such a display can depict any or all movement directions, commands, movement percentages performed, and / or hub and / or catheter indicators to show which devices are controlled by a particular control. In some implementations, the display can depict the applied force or resistance encountered by the catheter, or other measurements being detected or observed by a particular hub or interventional component.

[0126] In some implementations, the control mechanism 2200 can include a haptic component to provide haptic feedback to a user operating the controller. For example, if the controller 2202 is triggering catheter movement and the catheter detects a large force at the tip, the controller 2202 can generate haptic feedback to indicate to the user to stop or reverse the movement that was performed. In some implementations, haptic feedback can be generated in the controller to indicate to the user to use the controller to slow or speed up the movement. In some implementations, haptics can provide feedback regarding the accumulation of large torsional strains that may precede a sharp rotation or the accumulation of large axial forces that may be a precursor to catheter buckling.

[0127] The systems described herein can compare actual fluoroscopic image positions with input displacements from a controller. A static fluoroscopic image of the patient can be captured, in which the patient's vasculature is indexed relative to bony landmarks or one or more implanted soft tissue fiducial markers. A real-time fluoroscopic image can then be displayed as an overlay, aligned with the static image by fiducial marker registration. Visual observation of the compatibility of real-time movement with the static image, aided by detected force data, can help confirm proper navigation of the associated catheter or guidewire. The systems described herein can also display a comparison of the input proximal mechanical translation of the catheter or guidewire and the resulting distal tip output motion, or lack thereof. Loss of relative motion at the distal tip can indicate shaft buckling, prolapse, kinking, or similar consequences, either inside or outside the body. Such a comparison can be beneficial when shaft buckling, prolapse, kinking, or similar consequences occur outside the current fluoroscopic field of view.

[0128] 17 illustrates a side schematic view of a multi-catheter interventional device assembly 2900 for combined supra-aortic and / or neurovascular site access and treatment (e.g., aspiration) as described herein. The multi-catheter assembly 2900 can be configured for either manual or robotic procedures.

[0129] Interventional device assembly 2900 includes an insertion or access catheter 2902, a treatment catheter 2904, and a guide catheter 2906. Other components are possible, including, but not limited to, one or more guidewires (e.g., optional guidewire 2907), one or more guide catheters, an access sheath, and / or one or more other treatment catheters, and / or associated catheter (control) hubs. In some embodiments, assembly 2900 can also be configured with an optional deflection control 2908 for controlling the deflection of one or more catheters of assembly 2900.

[0130] In operation, the multi-catheter assembly 2900 can be used without the need to exchange hub components. For example, in the previously disclosed two-stage procedure, the first stage to achieve supra-aortic access involves loading the access catheter, guide catheter, and guidewire onto a support table. Once supra-aortic access is obtained, the access catheter and guidewire are typically removed from the guide catheter. A second catheter assembly is then introduced through the guide catheter after attaching a new guidewire hub and procedure catheter hub to corresponding drive carriages on the support table.

[0131] The single multi-catheter assembly 2900 of FIG. 17 is configured to be operated without the need to remove hubs and catheters and without the addition of additional assemblies and / or hubs. Thus, the multi-component access and treatment configuration of assembly 2900 can utilize a guidewire 2907 that is fabricated (configured) to function as both an access guidewire and a navigation guidewire, allowing for sufficient access and support to, and navigation of, a particular distal treatment site. In a non-limiting example configured for robotic implementation, catheter assembly 2900 can include a guidewire hub (e.g., guidewire hub 2909, or guidewire hub 26 (e.g., FIG. 3A) positioned on the drive table and to the right of catheter 2902 with respect to the orientation of FIG. 17), an insertion or access catheter hub 2910, a treatment catheter hub 2912, a guide catheter hub 2914, and corresponding catheters. In certain embodiments, one or more of the hubs can include or be coupled to a hemostatic valve (e.g., a rotary hemostatic valve) to accommodate the introduction of an interventional device and / or the introduction of fluids (e.g., saline, contrast) therethrough. In certain embodiments, one or more of the hubs can include or be coupled to a fluid system (which can include a hemostatic valve) for the introduction of fluids (e.g., saline, contrast) and for the application of vacuum for aspiration functions. Additional examples of hemostatic valves, fluid systems, and aspiration systems are included in U.S. Patent Application No. 17 / 879,614, entitled "Multi-Catheter System With Integrated Fluidics Management," filed August 2, 2022, which is expressly incorporated herein by reference in its entirety.

[0132] Once access is achieved above the aortic arch, the insertion or access catheter 2902 (associated with the insertion catheter hub 2910) can be "placed," for example, near the carotid ostium, and the remainder or subset of the catheter assembly can be guided more distally toward a particular site (e.g., clot site, surgical site, treatment site, etc.).

[0133] In some embodiments, additional smaller treatment catheters may be used at the site. In some implementations, with respect to catheter assembly 2900, in a robotic configuration of assembly 2900, catheter 2906 may function as a guide catheter. Catheter 2904 may function as a treatment (e.g., suction) catheter. In some embodiments, catheter 2906 may function to perform suction in addition to functioning as a guide catheter, instead of or in addition to catheter 2904. Access catheter 2902 may have a distal deflection zone and may function to access the desired ostium. Those skilled in the art will recognize from FIGS. 20A-20E that either manual or robotic manipulation of a multi-catheter stack is contemplated herein.

[0134] In some embodiments, catheter assembly 2900 (or other combined catheter assemblies described herein) can be driven to a predetermined location as a single unit. However, each catheter (or guidewire) component can instead be actuated and driven to the same or different locations independently of one another. Because each catheter will have its own stiffness profile over its length, the position and stacking of the catheters can be adjusted to find a corresponding optimal stiffness profile to help navigate the catheter stack over various anatomical obstacles.

[0135] In a non-limiting example, catheter assembly 2900 can be used for a diagnostic angiography procedure. In some embodiments, assembly 2900 can include only guidewire 2907 and access catheter 2902 (in the form of a diagnostic angiography catheter) for performing a diagnostic angiography procedure, or only guidewire 2907 and access catheter 2902 can be utilized during the procedure. Alternatively, guide catheter 2906 and treatment catheter 2904 can be retracted proximally to expose the distal end of access catheter 2902 (e.g., several centimeters of the distal end of the access catheter) to perform a diagnostic angiography procedure.

[0136] As shown in FIG. 17 , guide catheter 2906, treatment catheter 2904, access catheter 2902, and guidewire (or guiding element) 2907 can be arranged concentrically. FIG. 52 illustrates a distal end view representation of guide catheter 2906, treatment catheter 2904, access catheter 2902, and guidewire 2907, illustrating the concentric arrangement. For example, as shown in FIG. 52 , outer diameter 33 of guidewire 2907 is smaller than inner diameter 35 of access catheter 2902, and the system is configured such that guidewire 2907 can be positioned at least partially within the lumen of access catheter 2902. Outer diameter 37 of access catheter 2902 is smaller than inner diameter 37 of treatment catheter 2904, and the system is configured such that access catheter 2902 can be positioned at least partially within the lumen of treatment catheter 2904. The outer diameter of the treatment catheter 2904 is smaller than the inner diameter 39 of the guide catheter 2906, and the system is configured such that the treatment catheter 2904 can be positioned at least partially within the lumen of the guide catheter 2906. In certain embodiments, the guide catheter 2906 can be a "large bore" guide or access catheter having an inner diameter 39 of at least about 0.075, or at least about 0.080 inches in diameter. In one example, the inner diameter 39 of the guide catheter 2906 is 0.088". The treatment catheter 2904 can be an aspiration catheter having an inner diameter 37 in the range of about 0.060 inches to about 0.075 inches. The access catheter 2902 can be a steerable catheter with a deflectable distal tip having an inner diameter 35 in the range of about 0.025 inches to about 0.050 inches. In some examples, the access catheter 2902 has an inner diameter 35 of between about 0.045" and 0.049". This configuration allows for an effective cross-sectional area of ​​the access catheter's lumen for fluid communication when an appropriately sized guidewire 2907 is positioned therein, as described further herein.In some instances, a properly sized guidewire 2907 has an outer diameter 35 in the range of about 0.014 inches to about 0.020 inches (0.020"). In some instances, the guidewire 2907 can have an outer diameter 35 of 0.014", 0.015", 0.016", 0.017", 0.018", 0.019", 0.020", 0.021", 0.022", 0.023", or 0.024" plus or minus 0.0005". However, guidewires of smaller diameters (e.g., 0.014" to 0.020") are preferred to provide a desired effective cross-sectional area of ​​the access catheter for fluid infusion when the guidewire 2907 is at least partially positioned within the lumen of the access catheter 2902. In one example of a system configuration in which the system can inject contrast media (or another fluid) into the patient through the access catheter 2902 while the catheter is partially or fully positioned, the guide catheter 2906 can have an inner diameter 39 of about 0.088 inches, the treatment catheter 2904 can have an inner diameter 37 of about 0.071 inches, the access catheter 2902 can have an inner diameter 35 of about 0.035 inches to about 0.048 inches, and the guidewire 2907 can have an outer diameter 33 of about 0.018 inches. In one example, the guide catheter 2906 can have an outer diameter of about 0.110 inches, the treatment catheter 2904 can have an outer diameter of about 0.083 inches, and the access catheter 2902 can have an outer diameter of about 0.061 inches.

[0137] In some embodiments, the access catheter 2902 can have an inner diameter 35 of between about 0.046 inches and 0.047 inches, and the guidewire 2907 can have an outer diameter 33 of less than or equal to 0.024 inches, for example, in a range of between about 0.014 inches and about 0.024 inches. These configurations provide sufficient annular space within the lumen of the access catheter 2902 for the contrast medium to propagate through the lumen of the access catheter 2902, thus allowing the guidewire 2907 to remain in place while the contrast medium is being injected into the catheter assembly 2900. This advantageously reduces the overall procedure time by eliminating the need to remove the guidewire 2907 each time the contrast medium is injected to create sufficient annular space within the lumen of the access catheter 2902 for the contrast medium to flow through the lumen of the access catheter 2902. For example, these configurations provide for allowing contrast to flow inside the catheter at a flow rate of approximately 3 cc per second at a pressure not exceeding 400 psi. In some instances, such catheters are between approximately 100 cm and 160 cm in length. Additionally, this configuration reduces the risk of air embolism associated with repeated removal and reinsertion of the guidewire 2907 from (and into) the catheter assembly 2900.

[0138] As further described with reference to examples / trials, to provide a desired fluid flow through the access catheter 2902 while the guiding element 2907 is positioned therein, a particular effective cross-sectional area 41 of the access catheter 2902 should be available for communicating fluid from the proximal end to the distal end of the catheter and out of the access catheter. With reference to FIG. 52 , the effective cross-sectional area 41 of the access catheter 2902 (i.e., the space within the lumen of the access catheter 2902 through which fluid can be communicated when the guiding element 2907 is positioned therein) is determined by subtracting the cross-sectional area 43 of the guiding element 2907 from the cross-sectional area of ​​the access catheter 2902. At the described working pressures (e.g., less than about 400 psi), it has been determined through testing related to this unique configuration providing fluid communication through the access catheter with the guiding element positioned therein. An effective cross-sectional area 41 of at least about 0.001257 square inches is desired. In one example, an effective cross-sectional area 41 of at least 0.001407 square inches is desired to produce the desired contrast fluid flow at less than about 400 psi. Various dimensions of the outer diameter 33 of the guiding element 2907 and the inner diameter 35 of the access catheter 2902 can be utilized to achieve an effective cross-sectional area of ​​at least about 0.001257 square inches, as shown in the table below, which shows examples of determined effective cross-sectional areas of the access catheter for various access catheter inner diameter dimensions and various guiding element (GE) outer diameter dimensions, where the shaded cells indicate effective cross-sectional areas below the 0.001257 square inch threshold. In one example, as illustrated in the table, an access catheter ID of 0.045" and a guiding element OD of 0.020" provides an effective cross-sectional area of ​​the access catheter of 0.001276 square inches, which is acceptable (not shaded). The reason is that it exceeds the threshold of 0.001257 square inches.In another example, as illustrated in the table, an access catheter ID of 0.045" and a guiding element OD of 0.021" provides an effective cross-sectional area of ​​the access catheter of 0.001244 square inches, which is unacceptable (shaded) because it is below the (predetermined) threshold of 0.001257 square inches. The table below illustrates some examples, but other exemplary configurations that meet this threshold are possible.

[0139] [Table 1]

[0140] In some embodiments, the length of the access catheter 2902 can be between about 100 centimeters and 193 centimeters. In certain embodiments, the wall of the access catheter 2902 surrounding the lumen can include a braided reinforcement layer and an inner liner (e.g., PEBAX). The braided reinforcement layer can include stainless metal ribbon wire in a tight braid pattern. In one example, the metal ribbon wire can have a cross-sectional dimension of about 0.002" x about 0.005". In other embodiments, the braided reinforcement layer can include stainless metal round wire having a 0.002 inch diameter in a tight braid pattern (e.g., a 1:1 braid pattern or a 2:2 braid pattern). In various examples, the ribbon material can be made of or include stainless steel or other materials, including titanium, CoCr alloy, Elgiloy, or Hastelloy (Hastelloy alloy), etc.

[0141] The guide catheter 2906 and the access catheter 2902 can have a proximal end 1810 and a distal end 1812, respectively. In some embodiments, the distal end 1812 of the guide catheter 2906 and the access catheter 2902 can have hypotube tips 1806 and 1802, respectively, as shown in FIG. 18 . In some examples, the tips can include nitinol. In one example, the catheter tip can include a laser-cut hypotube constructed from nitinol, which is joined to another proximal laser-cut hypotube constructed from stainless steel. This advantageously allows for better pushability and torqueability due to the enhanced rigidity of the stainless steel material. Flexibility of the metal hypotube can be achieved through a pattern of cuts in its wall. In one example, an interrupted spiral pattern can achieve this. In another example, multiple cuts (e.g., a pattern of cuts or apertures) can be used to achieve the desired stiffness / flexibility of the catheter tip. The length of the cuts and the pitch between them can help define the stiffness of the catheter. One or more lasers can be used to create the cuts. In some embodiments, the hypotube tip is the same diameter (e.g., the outer diameter of the hypotube tip is the same diameter as the portion of the catheter adjacent to the hypotube tip). In some embodiments, the hypotube tip has a smaller diameter than the portion of the catheter proximal to the tip (e.g., the outer diameter of the hypotube tip is smaller than the outer diameter of the portion of the catheter proximal to the hypotube tip). This advantageously allows the distal tip to be small enough to engage the distal anatomy while having a stiffer proximal end, which allows for better pushability and torque control and reduced susceptibility to buckling.

[0142] FIG. 19 shows a cross-sectional view of a laser-cut hypotube 1902. In some embodiments, the laser-cut hypotube can be comprised of a metal (e.g., nitinol, stainless steel, etc.) scaffold 1906 defining a plurality of apertures 1904. In some embodiments, the distal end of the access catheter 2902 can include the laser-cut hypotube 1902 due to its enhanced heat-setting properties, which allow the access catheter to be properly shaped to navigate the patient's vasculature. In some embodiments, using a nitinol hypotube allows the catheter to be folded or bent during packaging. This is advantageous because the catheter may be too long to be packaged straight. The superelastic properties of nitinol further allow the catheter to be torqued without catheter whipping.

[0143] While the embodiments disclosed herein are described with respect to the injection of a contrast medium, those skilled in the art will recognize that these concepts may be applicable to any fluid (e.g., saline, medication, etc.) injected into the catheter assembly 2900. The viscosity of the liquid being injected into the catheter assembly 2900 may affect the annular space required within the lumen of the access catheter 2902 to allow for sufficient flow rate. Thus, depending on the viscosity of the liquid being injected into the catheter assembly 2900, a different diameter and / or length of the access catheter 2902 may be desirable than those described above. Similarly, to promote desired flow characteristics, a guidewire of a different diameter or a guidewire with different properties (e.g., having a hydrophilic coating) may be desirable depending on the properties of the liquid being injected into the catheter system. In some embodiments, a guiding element (e.g., a guidewire) may include different surface properties at its proximal and distal ends. In one example, a guiding element may include a hydrophilic coating at its distal end and a hydrophobic coating at its proximal end. In one example, the hydrophobic coating is polytetrafluoroethylene (PTFE). In one example, the hydrophobic coating includes a PTFE-based composition. In one example, the PTFE-based composition is Teflon. Examples detailed at the end of this disclosure illustrate different configurations of several embodiments of the catheter assembly 2900 that may be used.

[0144] 20A-20E depict an exemplary sequence of steps for introducing, either manually or robotically, a multi-catheter assembly configured to provide access to a blood clot. 20A-20E can be described using the interventional device assembly of FIG. 17. Other combinations of catheters can be substituted for the interventional device assembly, as one of ordinary skill in the art would recognize in light of the disclosure herein.

[0145] Referring to FIG. 20A , a three catheter interventional device assembly 2900 is shown being driven through an introducer sheath 3002, through an iliac artery 3004, and into the descending aorta. Next, the access catheter 2902, the treatment catheter 2904 (e.g., 0.071 inches), and the guide catheter 2906 (e.g., 0.088 inches) are tracked to the aortic arch 3006, as shown in FIG. 20B . Here, the distal end of the guide catheter 2906 can be placed below the aortic arch 3006, and the treatment catheter 2904, the access catheter 2902 (positioned within the treatment catheter 2904 and not visible in FIG. 20B ), and the guidewire 2907 can be driven (e.g., simultaneously or separately) into the ostium. In some embodiments, the access catheter 2902 is advanced out of the treatment catheter 2904 and the guide catheter 2906, engaging the ostium first. After the distal end of the access catheter 2902 is positioned within the desired ostium, a guidewire 2907 can be advanced distally into the ostium to secure (or guide) access and / or confirm proper vessel selection and positioning. After the access catheter 2902 and guidewire 2907 are positioned within the desired ostium, a treatment catheter 2904 and / or guide catheter 2906 can be advanced into (and, in some embodiments, beyond) the ostium, using the support of the access catheter 2902 and / or guidewire 2907 to navigate through the aorta and into the ostium. In the embodiment shown in FIG. 20B , the treatment catheter 2904 has been advanced into the ostium, while the guide catheter 2906 remains indwelling below the aortic arch 3006.

[0146] 20C, the guidewire 2907 can be advanced distally, and the radiopacity of the guidewire 2907 can be used to confirm under fluoroscopic imaging that access through the desired ostium has been achieved. The guidewire 2907 engages the origin of the brachiocephalic trunk 3014. The guidewire 2907 is then advanced to the petrous segment 3018 of the internal carotid artery 3016.

[0147] 20D, guide catheter 2906 and treatment catheter 2904 (positioned within guide catheter 2906 and not visible in FIG. 20D) are both advanced (e.g., simultaneously or sequentially) over guidewire 2907 and over insertion or access catheter 2902 (positioned within treatment catheter 2904 and not visible in FIG. 20D), while access catheter 2902 remains at the ostium for support. Guidewire 2907 can be advanced further beyond cone segment 3018 to the site of clot 3020, such as the M1 segment.

[0148] 20E , guide catheter 2906 and treatment catheter 2904 (positioned within guide catheter 2906 and not visible in FIG. 20E ) are advanced (e.g., simultaneously or sequentially) to position the distal tip of treatment catheter 2904 at the treatment site (e.g., at the face of clot 3020). Guidewire 2907 and access catheter 2902 (positioned within treatment catheter 2904 and not visible in FIG. 20E ) are removed, and aspiration of clot 3020 begins through treatment catheter 2904. That is, guidewire 2907 and access catheter 2902 are retracted proximally to allow aspiration through treatment catheter 2904. After aspiration of the clot, treatment catheter 2904 and guide catheter 2906 can be removed (e.g., simultaneously or sequentially). For example, in some embodiments, treatment catheter 2904 can be removed before removing guide catheter 2906.

[0149] The catheter assembly 2900 can be used to perform a neurovascular procedure, as illustrated in FIGS. 20A-20E. For example, the neurovascular procedure can be a neurovascular thrombectomy. The steps of the procedure can include providing an assembly including at least a guidewire, an access catheter, a guide catheter, and a treatment catheter. For example, the catheter assembly 2900 includes a guidewire 2907, an access catheter 2902, a guide catheter 2906, and at least one treatment catheter 2904. The treatment catheter 2904 can include an aspiration catheter, an embolism deployment catheter, a stent deployment catheter, a flow diverter deployment catheter, a diagnostic angiography catheter, a stent retriever catheter, a clot retrieval catheter, a balloon catheter, a catheter for facilitating percutaneous valve repair or replacement, an ablation catheter, and / or an RF ablation catheter or guidewire.

[0150] The neurovascular procedure may further include coupling the assemblies to a non-robotic or robotic drive system and driving the assemblies to achieve supra-aortic access. The steps may further include driving a subset of the assemblies to a neurovascular site and performing the neurovascular procedure using the subset of the assemblies. The subset of assemblies may include a guidewire, a guide catheter, and a treatment catheter.

[0151] Each of guidewire 2907, access catheter 2902, treatment catheter 2904, and guide catheter 2906 is configured to be regulated by a respective hub. For example, guidewire 2907 can include (or be coupled to) a hub (e.g., hub 26, FIG. 3A ) mounted on one of the tray assemblies described herein. Similarly, access catheter 2902 can include (or be coupled to) catheter hub 2910. Treatment catheter 2904 can include (or be coupled to) treatment catheter hub 2912. Guide catheter 2906 can include (or be coupled to) guide catheter hub 2914.

[0152] Generally, coupling of assembly 2900 can include magnetically coupling first hub 2909 (which is coupled to guidewire 2907) to a first drive magnet; second hub 2910 (which is coupled to access catheter 2902) to a second drive magnet; third hub 2912 (which is coupled to treatment catheter 2904) to a third drive magnet; and fourth hub 2914 (which is coupled to guide catheter 2906) to a fourth drive magnet. In various embodiments, there can be one layer of material or multiple layers of material (i.e., one or more layers of material) between each of the first, second, third, and fourth hubs and their corresponding first, second, third, and fourth drive magnets, such that the magnetic coupling occurs through the layers of material. In various embodiments, each layer can be flexible, semi-rigid, or rigid. The layer can be a sterile barrier. When the system is configured for use, the first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet are each independently movable and movably carried by (or on) a drive table, for example, as described with respect to the tray assembly and controller described herein. In some embodiments, the first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet are coupled to their respective catheter hubs through a sterile barrier (e.g., a sterile barrier and a fluid barrier). Each of the first, second, third, and fourth drive magnets can be controlled to be independently movable relative to the other drive magnets. Each of the first, second, third, and fourth drive magnets can be incorporated onto a drive table having multiple drive magnets controlled to move along the drive table (e.g., along the longitudinal axis of the drive table).In some embodiments, two or more drive magnets can be tethered or otherwise coupled together to move as a unit in response to commands from a single controller. In some examples, the drive magnets can be coupled together to move together (e.g., physically coupled together or configured to move together by a controller). In one example, the first and second drive magnets can be configured to move together along the drive table. In another example, the first, second, third, and fourth drive magnets can be configured to move together. In another example, any two or more of the first, second, third, and fourth drive magnets (and correspondingly, the hubs to which the first, second, third, and fourth drive magnets are coupled) can be configured to move together along the drive table.

[0153] In some implementations, performing a neurovascular procedure can include driving the assembly in response to movement of the hub adapter along the support table until the assembly is positioned to provide supra-aortic vascular access. The hub adapter can include, for example, a coupler / carriage that acts as a shuttle by advancing proximally or distally along a track in response to an operator command. The hub adapters described herein can each include at least one drive magnet configured to couple with a magnet (sometimes referred to herein as a “driven magnet”) carried by the respective hub. This provides a magnetic coupling between the drive magnet and the driven magnet through the sterile barrier such that, in response to movement of the hub adapter positioned outside the sterile field (as described in detail in FIG. 4 ), the respective hub is moved across the top of the sterile barrier (within the sterile field). Movement of the hub adapters is driven by a drive system carried by the support table on which the guidewire hub 2909, access catheter hub 2910, procedure catheter hub 2912, and guide catheter hub 2914 are mounted.

[0154] Moving the catheter assembly 2900 during a procedure can include moving an upper portion of the catheter assembly 2900. For example, moving the catheter assembly 2900 during a procedure can further include actuating a subset of the assemblies in response to movement of one or more of the hub adapters along the support table until the subset of the assemblies is positioned to perform a neurovascular procedure at the neurovascular treatment site. The subset of the assemblies can include the guidewire 2907, the guide catheter 2906, and / or the treatment catheter 2904.

[0155] In some embodiments, the guidewire 2907, guide catheter 2906, and treatment catheter 2904 are advanced as a unit through (with respect to the guidewire 2907) and over (with respect to the guide catheter 2906 and treatment catheter 2904) at least a portion of the length of the access (e.g., insertion) catheter 2902 after supra-aortic access has been achieved.

[0156] In some embodiments, the catheter assembly 2900 can be part of a robotic control system for achieving supra-aortic access and neurovascular treatment site access, as illustrated in FIGS. 20A-20E. In some embodiments, the catheter assembly 2900 can be part of a manually controlled system for achieving supra-aortic access and neurovascular treatment site access. In some embodiments, the catheter assembly 2900 can be part of a hybrid control system (comprising manual and robotic components) for achieving supra-aortic access and neurovascular treatment site access. For example, in such a hybrid system, the supra-aortic access can be robotically driven, while the neurovascular site access and embolectomy or other procedure can be manual. Alternatively, in such a hybrid system, the supra-aortic access can be manual, while the neurovascular site access can be robotically achieved. Furthermore, in such a hybrid system, any one or more of the guidewire, access catheter, guide catheter, or treatment catheter can be robotically driven or manually operated.

[0157] The exemplary robotic control system can include at least a guidewire hub (e.g., guidewire hub 2909) configured to adjust the axial and rotational positions of guidewire 2907. The robotic control system can also include an access catheter hub 2910 configured to adjust the axial and rotational movement of access catheter 2902. The robotic control system can also include a guide catheter hub 2914 configured to control the axial movement of guide catheter 2906. The robotic control system can also include a treatment catheter hub 2912 configured to adjust the axial and rotational position of treatment catheter 2904.

[0158] In some embodiments, the treatment catheter hub 2912 is further configured to laterally deflect the treatment catheter 2904 through a distal deflection zone.

[0159] In some embodiments, guidewire hub 2909 is configured to couple to the guidewire hub adapter by magnetically coupling the guidewire hub to a first drive magnet. Access catheter hub 2910 is configured to couple to the access catheter hub adapter by magnetically coupling the access catheter hub 2910 to a second drive magnet. Treatment catheter hub 2912 is configured to couple to the treatment catheter hub adapter by magnetically coupling the treatment catheter hub 2912 to a third drive magnet. Guide catheter hub 2914 is configured to couple to the guide catheter hub adapter by magnetically coupling the guide catheter hub 2914 to a fourth drive magnet. In some embodiments, the first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet are independently movably carried by a drive table.

[0160] In some embodiments, the robotic control system includes a first driven magnet on the guidewire hub 2909. The first driven magnet can be configured to cooperate with the first drive magnet such that the first driven magnet is configured to move in response to movement of the first drive magnet. In some embodiments, the first drive magnet is configured to move outside the sterile field separated from the first driven magnet by a barrier, while the first driven magnet is within the sterile field. In some embodiments, the position of the first driven magnet is movable in response to manipulation of a treatment drive control on a control console associated with the drive table. The interaction of the drive magnet and driven magnet is described in detail in FIG. 4 above.

[0161] In some embodiments, the robotic control system includes a second driven magnet on the access catheter hub 2910. The second driven magnet can be configured to cooperate with the second drive magnet such that the second driven magnet is configured to move in response to movement of the second drive magnet. In some embodiments, the second drive magnet is configured to move outside the sterile field separated from the second driven magnet by a barrier, while the second driven magnet is within the sterile field.

[0162] In some embodiments, the robotic control system includes a third driven magnet on the treatment catheter hub 2912. The third driven magnet can be configured to cooperate with the third drive magnet such that the third driven magnet is configured to move in response to movement of the third drive magnet. In some embodiments, the third drive magnet is configured to move outside the sterile field separated from the third driven magnet by a barrier, while the third driven magnet is within the sterile field.

[0163] In some embodiments, the robotic control system includes a fourth driven magnet on the guide catheter hub 2914. The fourth driven magnet can be configured to cooperate with the fourth drive magnet such that the fourth driven magnet is configured to move in response to movement of the fourth drive magnet. In some embodiments, the fourth drive magnet is configured to move outside the sterile field separated from the fourth driven magnet by a barrier, while the fourth driven magnet is within the sterile field. In some embodiments, there can be more than four driven magnets and corresponding catheter hubs for control of additional catheters.

[0164] In some embodiments, the devices described herein (e.g., hubs, hub adapters, interventional devices, and / or trays) can be used during robotically driven procedures. For example, in a robotically driven procedure, one or more of the interventional devices can be driven through the vasculature to a treatment site. Robotically driving such devices can include engaging electromechanical components controlled by user input. In some implementations, a user can provide input at a control system that interfaces with one or more hubs and hub adapters.

[0165] In some embodiments, the hubs, hub adapters, interventional devices, and trays described herein can be used during non-robotic (e.g., manually driven) procedures. Manually driving such devices can include manually engaging the hub to affect movement of the interventional device.

[0166] In some embodiments, the devices described herein can be used to perform a method of performing an intracranial procedure at an intracranial site. The method of performing an intracranial procedure can include any of the same steps described herein for performing a neurovascular procedure. The procedure can be performed robotically, manually, or a hybrid combination of both.

[0167] While the foregoing describes magnetic coupling of the hub to the drive magnet, in other embodiments, either the interventional device and / or the hub can be mechanically coupled to the drive system. Any of the methods described herein can include mechanically coupling one or more interventional devices (e.g., guidewire 2907, access catheter 2902, treatment catheter 2904, and / or guide catheter 2906) and / or one or more hubs (e.g., guidewire hub 2909, access catheter hub 2910, treatment catheter hub 2912, and / or guide catheter hub 2914) to one or more drive mechanisms.

[0168] 21 illustrates an embodiment of a mechanical linkage 1654 between the drive mechanism 1650 and the driven mechanism 1652. The drive mechanism 1650 and the driven mechanism 1652 can have any of the same or similar features or functionality as the drive magnet 67 and the driven magnet 69, respectively, unless otherwise described herein. The drive mechanism 1650 can be part of or coupled to a hub adapter (e.g., hub adapter 48). The driven mechanism 1652 can be part of or coupled to a hub (e.g., hub 36, guidewire hub 2909, access catheter hub 2910, procedure catheter hub 2912, or guide catheter hub 2914). In some cases, the mechanical linkage 1654 can include structural support (e.g., support rods or support struts) extending transversely through a seal in the sterile barrier 1632. The seal can allow the structural support to be advanced along the length of the sterile barrier 1632 while still maintaining a seal with the structural support to maintain a sterile field when the drive mechanism 1650 and driven mechanism 1652 are advanced and / or retracted, as described herein. For example, the seal can include a tongue and groove closure mechanism along the sterile barrier 1632 that is configured to close on either side of the structural support while allowing passage of the structural support through the sterile barrier 1632 and maintaining a seal against the structural support as the structural support is advanced along the length of the sterile barrier 1632.

[0169] In some embodiments, the structural support can extend through an elongated self-closing seal between two adjacent joining edges (e.g., similar in shape to duckbill valves) of flexible material extending along an axis. As the structural support advances along the axis between the joining edges, the joining edges can allow the structural support to advance and then be biased back into sealing engagement with one another as the structural support passes any given point along the axis.

[0170] In some embodiments, the drive mechanism can be a splined drive shaft (e.g., a non-sterile splined drive shaft). The mechanical linkage 1654 can include a pulley in the plate that serves as the sterile barrier 1632 and a sterile splined shaft configured to couple to the driven mechanism 1652. The driven mechanism 1652 can be a sterile pulley that receives the sterile splined shaft from the sterile barrier. In some embodiments, one or more splined drive shafts can engage and turn a corresponding pulley in the plate that serves as the sterile barrier. Each hub can have a sterile pulley configured to receive the sterile splined shaft from the sterile barrier plate. Rotation of the splined drive shaft can turn a pulley in the sterile barrier plate, which can turn a sterile pulley in the hub via the sterile splined shaft.

[0171] It will be understood by those skilled in the art that any of the embodiments as described herein may be modified to incorporate a mechanical linkage, for example, as shown in FIG. 21.

[0172] The interventional devices described herein can be provided individually, or at least some of the interventional devices can be provided in a pre-assembled (e.g., nested or stacked) configuration, e.g., as part of a sterile kit. In one example, the interventional devices can be provided in the form of an interventional device assembly (e.g., interventional device assembly 2900) in a concentric nested or stacked configuration. If provided individually, each catheter (and, in some embodiments, each corresponding catheter hub) can be unpackaged and primed, e.g., by flushing the catheter (and, in some embodiments, each corresponding catheter hub) to remove air from its inner lumen and replacing it with a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium). After priming, the interventional devices can be manually assembled into a stacked configuration, e.g., through an introducer sheath, so that they are ready for introduction into the body for a surgical procedure.

[0173] Assembling the devices into a stacked configuration can include inserting the interventional devices individually into one another in order of size. For example, the interventional device with the second largest diameter can be inserted into the lumen of the interventional device with the largest diameter. Then, the interventional device with the third largest diameter can be inserted into the interventional device with the second largest diameter, and so on.

[0174] 17 , assembly can be performed by first inserting the distal end of catheter 2904 through hub 2914 and into catheter 2906. Catheter 2904 can be advanced through catheter 2906 until the distal tip of catheter 2904 is flush with or extends beyond the distal tip of catheter 2906 and / or until catheter 2904 cannot be inserted further. The distal end of catheter 2902 can then be inserted through hub 2912 and into catheter 2904. Catheter 2902 can be advanced through catheter 2904 until the distal tip of catheter 2902 is flush with or extends beyond the distal tip of catheter 2904 and / or until catheter 2902 cannot be inserted further. The distal end of guidewire 2907 can then be inserted through hub 2910 and into catheter 2902. Guidewire 2907 can be advanced through catheter 2902 until the distal tip of guidewire 2907 is flush with or extends beyond the distal tip of catheter 2902 and / or until guidewire 2907 cannot be inserted any further.

[0175] Embodiments in which two or more interventional devices are packaged together as a single unit in an assembled (e.g., nested or stacked) configuration can provide efficient unpackaging and preparation before use, as well as efficient assembly within a robotic control system. The interventional devices can be pre-loaded onto their respective hubs before packaging. In certain embodiments, two, three, or more interventional devices can be packaged in a fully nested (i.e., fully axially inserted) or nearly fully nested configuration. In a fully nested configuration, each interventional device is inserted as far as possible into the adjacent distal hub and interventional device. Such a fully nested configuration can minimize the total length of the interventional device assembly and minimize the size of the packaging required to accommodate the interventional device assembly.

[0176] In some embodiments, the interventional device can also be sterilized while in the assembled configuration prior to packaging, for example, using ethylene oxide gas. In some embodiments, the interventional device can be packaged while in the assembled configuration prior to sterilization with ethylene oxide gas. For interventional devices in a nested or stacked configuration, ethylene oxide gas can be provided in the space between adjacent interventional devices (e.g., the annular lumen between the outer diameter of a first interventional device nested within a second interventional device and the inner diameter of the second interventional device) for sterilization. In some embodiments, the interventional device assembly can be packaged in a thermoformed tray and sealed with an HDPE (e.g., Tyvek®) lid. The interventional device assembly can be unpackaged by a user in a sterile field by removing (e.g., opening or peeling) the lid. The user in the sterile field can then remove the interventional device assembly and place it on a sterile work surface, for example, of a robot-driven table, as described herein.

[0177] Packaging the interventional devices in an assembled configuration and in a sterile state can reduce the time associated with unpackaging and assembling individual interventional devices and facilitate efficient connection to a robotic drive system. Each interventional device and hub combination can be further packaged with fluidic connections for connection to a fluid source, or one or more fluid and / or vacuum sources. In some embodiments, each hub or a hemostasis valve coupled to the hub can include a fluidic connection.

[0178] Priming can be performed after the interventional device assembly is unpackaged (e.g., after the interventional device assembly is positioned on a robotic-driven table) while the devices are concentrically nested or stacked. This is preferably accomplished within each catheter lumen (e.g., the annular lumen between the guide catheter 2906 and the treatment catheter 2904) and between each additional concentric interventional device in the catheter stack. In certain embodiments, fluid can be introduced into one or more lumens of the catheter stack to prime one or more interventional devices. For example, fluid can be introduced into the lumen between the distal hub and the proximal interventional device (e.g., the lumen between the hub 2914 and the catheter 2904). In certain embodiments, priming can be performed while the devices are in sterile packaging. More typically, priming of one or more of the catheters in the catheter stack can be performed when the catheter assembly is removed from its packaging.

[0179] The fluidic connections of the catheter assemblies (e.g., fluidic connections to one or more of the hubs) can be connected to a fluidics system for delivering saline and contrast media to the catheters and for providing suction. In some embodiments, one or more of the fluidic connections (e.g., to saline, contrast media, or suction) can extend from the sterile field to outside the sterile field for connection to the fluidics system. Once connected, the fluidics system can perform a priming sequence to flush each catheter of the interventional device assemblies with a fluid (e.g., saline, contrast media, or a mixture of saline and contrast media). The priming sequence can also include flushing each corresponding catheter hub with the fluid. The fluid can be degassed or degassed by the fluidics system before priming. In some embodiments, a vacuum source of the fluidics system can be used to evacuate air from each catheter during fluid flushing. In certain embodiments, the catheter tip can be placed into a container of fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) during priming, such that when a vacuum source is applied, the fluid (but not air) in the container is aspirated through the catheter tip. In other embodiments, the catheter tip can be blocked (e.g., using a plug) to prevent air from being aspirated through the catheter tip when a vacuum source is applied. In certain embodiments, the priming process can be automated so that a user can provide a single command, and each catheter (and, in some embodiments, each corresponding catheter hub) can be primed sequentially (e.g., as described with respect to FIGS. 22A-22C) or simultaneously.

[0180] Additional details regarding the fluidics system are disclosed in U.S. Patent Application No. 17 / 879,614, entitled "Multi Catheter System With Integrated Fluidics Management," filed August 2, 2022, which is attached hereto (Appendix A) and expressly incorporated herein in its entirety.

[0181] When there is a reduction in the lumen cross-sectional area for flow, for example, when a second interventional device (e.g., a catheter or guidewire) extends into the lumen of a first interventional device, the fluid resistance within the lumen may be greater. The amount of fluid resistance may be affected by the length of the cross-sectional constriction, for example, due to the depth of axial insertion of the second interventional device within the first interventional device. A second interventional device extending partially through the lumen of the first interventional device may provide a smaller length of cross-sectional constriction and thus result in lower fluid resistance within the lumen of the first catheter than if the second interventional device extended completely through the lumen of the first interventional device. Therefore, fluid resistance can be reduced at least in part by reducing the depth of axial insertion (i.e., axial overlap) of the second interventional device into the lumen through which fluid will be injected (e.g., the length of the second interventional device into its concentrically adjacent lumen).

[0182] In some embodiments, when a certain depth of insertion of a second interventional device within a first interventional device is exceeded (e.g., when the second interventional device is at or near its maximum insertion depth within the first interventional device), the size of the fluid channel between the devices (e.g., the annular lumen between the first and second interventional devices) may lead to a higher than desirable amount of fluid resistance during the priming procedure. In some embodiments, the depth of insertion of the second interventional device within the first interventional device can be reduced to reduce the pressure required to prime the catheter and to reduce internal interference.

[0183] In some embodiments, catheters in an interventional device assembly can be separated from other interventional devices for priming to reduce the pressure required to prime the catheter and to reduce internal interference. The catheter being primed can be separated from the interventional device in the catheter's lumen by retracting the interventional device proximally within the catheter's lumen. For example, the interventional device in the lumen of the priming catheter can be retracted as proximally as possible from the priming catheter while still maintaining a nested or stacked relationship (e.g., at least about 2 cm or 5 cm or more of axial overlap) to minimize the pressure required to prime the catheter and to minimize internal interference. In other words, a catheter can be separated from a more proximal interventional device for priming while the distal tip of the adjacent proximal interventional device is still positioned within the catheter's lumen. Maintaining at least some of the distal tips of the adjacent proximal interventional devices within the catheter's lumen can allow for easier reinsertion and advancement of the proximal interventional device after priming.

[0184] In some embodiments, the axial overlap can be between about 2 cm and about 20 cm, between about 2 cm and 10 cm, between about 2 cm and 5 cm, between about 5 cm and 20 cm, between about 5 cm and 10 cm, or any other suitable range. In some embodiments, the axial overlap can be at least about 2 cm, at least about 5 cm, at least about 10 cm, at least about 20 cm, 2 cm or less, 5 cm or less, 10 cm or less, 20 cm or less, about 2 cm, about 5 cm, about 10 cm, about 20 cm, or any other suitable amount. For example, in some embodiments, the axial overlap can be about 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, 11 cm, 12 cm, 13 cm, 14 cm, 15 cm, 16 cm, 17 cm, 18 cm, 19 cm, or 20 cm, plus or minus 0.5 cm.

[0185] In some embodiments, the robotic drive table can be programmed to retract the inner interventional device as proximally as possible from the catheter being primed while still maintaining the nested or stacked relationship. In other embodiments, the robotic drive table can be programmed to separate the inner device from the catheter being primed a sufficient distance to optimize the length of the unobstructed lumen and to result in an amount of fluid resistance below a threshold. After the catheter being primed is separated from the other interventional devices, the catheter can be primed by flushing it with a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium, etc.).

[0186] After a catheter is primed, it can be returned to its initial position, and the next catheter in the interventional device assembly can be separated from the other interventional devices in its lumen for priming. This sequence can be repeated for each catheter in the interventional device assembly. In other embodiments, after a catheter is primed, it can be advanced to a ready or actuated position to begin insertion into the patient. While the foregoing describes separating the catheter to be primed by retracting the inner interventional device, the outer catheter can also be separated from the inner interventional device by advancing the outer catheter axially distally relative to the inner interventional device. An example of a priming process is described with reference to FIGS. 22A-22C.

[0187] FIG. 22A depicts the interventional device assembly 2900 assembled in an axially compressed configuration in a concentric stack. As shown in FIG. 22A, the interventional devices can be fully nested within one another. This can be the configuration following unpackaging and placement of the device assembly 2900 on a robotic drive table. The priming sequence can begin, for example, as shown in FIG. 22B, by axially advancing catheter 2906 and hub 2914 distally relative to catheter 2904, hub 2912, catheter 2902, hub 2910, guidewire 2907, and hub 2909 as far as possible while maintaining the distal tip of catheter 2904 within the lumen of catheter 2906, or to a distance that will result in a desired amount of fluid resistance for priming. In some embodiments, catheter 2906 is advanced in response to a control signal from a control system. Catheter 2906 can then be primed by introducing a priming fluid using the fluidics system. In some embodiments, the priming fluid is introduced in response to a control signal from a control system. Priming the catheter 2906 can include priming the hub 2914. For example, in certain embodiments, the hub 2914 or a hemostasis valve coupled thereto can include a fluidic connection for receiving the priming fluid from the fluidics system. After priming, the catheter 2906 can be returned to its initial position (e.g., a fully axially compressed configuration), as shown in FIG. 22A. In some embodiments, the catheter 2906 is returned to its initial position in response to a control signal from the control system.

[0188] After catheter 2906 has been primed and returned to its initial position, catheter 2904 and hub 2912 can be axially advanced distally relative to catheter 2902, hub 2910, guidewire 2907, and hub 2909 (and catheter 2906 and hub 2914 can be advanced axially distally without or only minimally changing their relative position with respect to catheter 2904), for example, as shown in FIG. 22C . In some embodiments, catheter 2904 and catheter 2906 are advanced in response to control signals from a control system. Catheter 2904 can then be primed by introducing a priming fluid using the fluidics system. In some embodiments, the priming fluid is introduced in response to a control signal from the control system. Priming catheter 2904 can include priming hub 2912. For example, in certain embodiments, hub 2912 or a hemostasis valve coupled thereto can include a fluidic connection for receiving priming fluid from a fluidics system. After priming, catheters 2904 and 2906 can be returned to their initial position (e.g., a fully axially compressed configuration), as shown in FIG. 22A. In some embodiments, catheters 2904 and 2906 are returned to their initial position in response to a control signal from a control system.

[0189] After catheter 2904 has been primed and returned to its initial position, catheter 2902 and hub 2910 can be advanced axially distally relative to guidewire 2907 and hub 2909 (and catheter 2906, hub 2914, catheter 2904, and hub 2912 can be advanced axially distally without or minimally changing their relative positions relative to catheter 2902), for example, as far as possible while maintaining the distal tip of guidewire 2907 within the lumen of catheter 2902, or to a distance that will result in a desired amount of fluid resistance for priming. In some embodiments, catheter 2902, catheter 2904, and catheter 2906 are advanced in response to control signals from a control system. Catheter 2902 can then be primed by introducing a priming fluid using the fluidics system. In some embodiments, the priming fluid is introduced in response to a control signal from the control system. Priming catheter 2902 can include priming hub 2910. For example, in certain embodiments, hub 2910 or a hemostasis valve coupled thereto can include a fluidic connection for receiving priming fluid from a fluidics system. After priming, catheter 2902 and catheters 2904 and 2906 can be returned to their initial positions (e.g., fully axially compressed configurations) shown in FIG. 22A. In some embodiments, catheter 2902, catheter 2904, and catheter 2906 are returned to their initial positions in response to control signals from a control system.

[0190] 22A-22C can be performed in response to a single control signal from a control system. In other embodiments, various steps of the priming procedure can be performed in response to unique control signals. In some embodiments, the priming of each unique interventional device can be performed in response to a unique control signal.

[0191] In an alternative embodiment, each of the catheters can be distally separated from one another simultaneously for priming. For example, catheter 2902 can be distally separated from guidewire 2907 while maintaining the distal tip of guidewire 2907 within the lumen of catheter 2902, catheter 2904 can be distally separated from catheter 2902 while maintaining the distal tip of catheter 2902 within the lumen of catheter 2904, and catheter 2906 can simultaneously be distally separated from catheter 2904 while maintaining the distal tip of catheter 2904 within the lumen of catheter 2906. However, as described with respect to FIGS. 22A-22C , embodiments in which only one set of adjacent hubs is separated at a time can provide a smaller overall length of the assembly at any particular time, which can enable use with smaller robotic drive systems. Although the separation of the outer catheter from the inner interventional device is described as advancing the catheter axially distally relative to the inner interventional device, the separation can include retracting the inner interventional device proximally from the outer catheter.

[0192] In alternative embodiments, one or more of catheter 2902, catheter 2904, and catheter 2906 can be advanced to a ready or driven position to begin insertion into a patient after priming (e.g., before priming a subsequent catheter). In such embodiments, the catheters can be advanced to the ready or driven position after priming without returning to their initial positions.

[0193] As explained above, in some embodiments, catheters 2902, 2904, and 2906 can be assembled into the concentric stack orientation shown in FIG. 17 before flushing the catheters to remove air by replacing it with a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium). This is preferably accomplished within each fluid lumen, such as the annular lumen between catheter 2906 and catheter 2904, and between each additional concentric interventional device in the concentric stack. Infusing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure can displace substantially all of the air, although some small bubbles may remain and may adhere to the inner wall of the outer catheter (e.g., guide catheter 2906), the outer wall of the inner catheter (e.g., treatment catheter 2904), or both.

[0194] While fluid is introduced under pressure into the proximal end of the annular lumen (e.g., into the hub of the outer catheter or a hemostatic valve connected thereto), the inner catheter can be moved relative to the outer catheter, breaking the holding forces between the microbubbles and the adjacent wall and allowing the bubbles to be carried downstream and exit through the distal opening of the lumen or removed via suction. The catheters can be moved axially, rotationally, or both relative to each other. In certain embodiments, the catheters can be reciprocated axially, rotationally, or both relative to each other. In some embodiments, the catheters can be moved axially, rotationally, or both intermittently. In other embodiments, the catheters can be rotated continuously or in a constant direction. In some embodiments, the catheters are moved using a drive mechanism (e.g., a magnetically coupled drive system) that moves the catheter hub.

[0195] In some implementations, the first catheter is reciprocated axially relative to an adjacent catheter or guidewire over a stroke length in the range of, for example, about 1 mm to about 250 mm, about 10 mm to about 250 mm, about 5 mm to about 125 mm, about 25 mm to about 125 mm, about 10 mm to about 50 mm, about 15 mm to about 30 mm, about 5 mm to about 30 mm, about 15 mm to about 25 mm, about 20 mm to about 40 mm, or any other suitable range. In some implementations, the first catheter is reciprocated axially relative to an adjacent catheter or guidewire over a stroke length of, for example, at least 5 mm, at least 10 mm, at least 15 mm, at least 20 mm, at least 25 mm, at least 30 mm, at least 50 mm, 10 mm or less, 20 mm or less, 25 mm or less, 30 mm or less, 50 mm or less, 125 mm or less, 150 mm or less, about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 50 mm, or any other suitable stroke length.

[0196] In some implementations, the first catheter is reciprocated axially relative to an adjacent catheter or guidewire at a reciprocating frequency in the range of about 0.5 Hz to about 1 Hz, about 1 Hz to about 5 Hz, about 1 Hz to about 10 Hz, about 1 Hz to about 25 Hz, about 5 Hz to about 10 Hz, about 10 Hz to about 25 Hz, or any other suitable range of frequencies, etc. In some implementations, the first catheter is reciprocated axially relative to an adjacent catheter or guidewire at a reciprocating frequency of, for example, at least 0.5 Hz, at least 1 Hz, at least 2 Hz, at least 5 Hz, at least 10 Hz, at least 25 Hz, 0.5 Hz or less, 1 Hz or less, 2 Hz or less, 5 Hz or less, 10 Hz or less, 25 Hz or less, about 0.5 Hz, about 1 Hz, about 2 Hz, about 5 Hz, about 10 Hz, about 25 Hz, or any other suitable frequency, etc.

[0197] In one implementation, the first catheter is reciprocated axially relative to an adjacent catheter or guidewire, for example, at a reciprocating frequency of about 5 cycles per second or less, or 2 cycles per second or less, over a stroke length in the range of about 0.5 inches to about 10 inches, or about 1 inch to about 5 inches.

[0198] In some implementations, the first catheter may be oriented at an angle, e.g., in the range of about 5 degrees to about 180 degrees, about 5 degrees to about 360 degrees, about 15 degrees to about 180 degrees, about 15 degrees to about 150 degrees, about 15 degrees to about 120 degrees, about 15 degrees to about 90 degrees, about 15 degrees to about 60 degrees, about 15 degrees to about 30 degrees, about 30 degrees to about 180 degrees, about 30 degrees to about 150 degrees, about 30 degrees to about 120 degrees, about 30 degrees to about 90 degrees, about 30 degrees to about 60 degrees, about 60 degrees to about to about 180 degrees, about 60 degrees to about 150 degrees, about 60 degrees to about 120 degrees, about 60 degrees to about 90 degrees, about 90 degrees to about 180 degrees, about 90 degrees to about 150 degrees, about 90 degrees to about 120 degrees, about 120 degrees to about 180 degrees, about 120 degrees to about 150 degrees, about 150 degrees to about 180 degrees, or any other suitable range of rotational angles per stroke. In some implementations, the first catheter is rotationally reciprocated relative to an adjacent catheter or guidewire through a rotational angle per stroke of, for example, at least 5 degrees, at least 15 degrees, at least 30 degrees, at least 60 degrees, at least 90 degrees, at least 120 degrees, at least 150 degrees, at least 180 degrees, at least 360 degrees, 5 degrees or less, 15 degrees or less, 30 degrees or less, 60 degrees or less, 90 degrees or less, 120 degrees or less, 150 degrees or less, 180 degrees or less, 360 degrees or less, about 5 degrees, about 15 degrees, about 30 degrees, about 60 degrees, about 90 degrees, about 120 degrees, about 150 degrees, about 180 degrees, about 360 degrees, or any other suitable angle.

[0199] In some implementations, the first catheter is reciprocated rotationally relative to an adjacent catheter or guidewire at a reciprocating frequency in the range of about 0.5 Hz to about 1 Hz, about 1 Hz to about 5 Hz, about 1 Hz to about 10 Hz, about 1 Hz to about 25 Hz, about 5 Hz to about 10 Hz, about 10 Hz to about 25 Hz, or any other suitable range of frequencies, etc. In some implementations, the first catheter is reciprocated rotationally relative to an adjacent catheter or guidewire at a reciprocating frequency of at least 0.5 Hz, at least 1 Hz, at least 2 Hz, at least 5 Hz, at least 10 Hz, at least 25 Hz, 0.5 Hz or less, 1 Hz or less, 2 Hz or less, 5 Hz or less, 10 Hz or less, 25 Hz or less, about 0.5 Hz, about 1 Hz, about 2 Hz, about 5 Hz, about 10 Hz, about 25 Hz, or any other suitable frequency, etc.

[0200] In some embodiments, the first catheter is reciprocated relative to an adjacent catheter or guidewire through between 1 and 200, between 1 and 100, between 1 and 50, between 1 and 25, between 1 and 15, between 1 and 10, between 1 and 5, between 5 and 25, between 5 and 15, between 5 and 10, or any other suitable range of reciprocations. In some embodiments, the first catheter is reciprocated relative to an adjacent catheter or guidewire through at least 1 reciprocation, at least 2 reciprocations, at least 5 reciprocations, at least 10 reciprocations, at least 15 reciprocations, at least 25 reciprocations, at least 50 reciprocations, 5 reciprocations or less, 10 reciprocations or less, 15 reciprocations or less, 25 reciprocations or less, 50 reciprocations or less, 100 reciprocations or less, 200 reciprocations or less, about 1 reciprocation, about 2 reciprocations, about 5 reciprocations, about 100 reciprocations, about 200 reciprocations, or any other suitable number. One reciprocating motion can include movement (axially or rotationally) from a first position to a second position, followed by movement from the second position back to the first position.

[0201] In some implementations, the first catheter is reciprocated or rotationally moved relative to the adjacent catheter or guidewire for a length of time in the range of about 1 second to about 60 seconds, about 1 second to about 45 seconds, about 1 second to about 30 seconds, about 1 second to about 20 seconds, about 1 second to about 15 seconds, about 1 second to about 10 seconds, about 5 seconds to about 45 seconds, about 5 seconds to about 30 seconds, about 5 seconds to about 20 seconds, about 5 seconds to about 15 seconds, about 5 seconds to about 10 seconds, about 10 seconds to about 30 seconds, about 10 seconds to about 20 seconds, or any other suitable range. In some implementations, the first catheter is reciprocated relative to the adjacent catheter or guidewire for a length of time of at least 1 second, at least 5 seconds, at least 10 seconds, at least 15 seconds, at least 20 seconds, at least 30 seconds, at least 45 seconds, at least 60 seconds, 5 seconds or less, 10 seconds or less, 15 seconds or less, 20 seconds or less, 30 seconds or less, 45 seconds or less, 60 seconds or less, about 5 seconds, about 10 seconds, about 15 seconds, about 20 seconds, about 30 seconds, about 45 seconds, about 60 seconds, or any other suitable length of time.

[0202] Reciprocating movement of adjacent catheters to destroy microbubbles can be accomplished manually by grasping the corresponding catheter hubs and manually moving the catheters axially or rotationally relative to one another while delivering pressurized fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium). Alternatively, such as in a robotically driven system, the processor can be configured to robotically drive at least one of two adjacent catheter hubs (e.g., at least one of hubs 2914 and 2912) to effect relative movement between the adjacent catheters, thereby destroying and expelling microbubbles, such as in response to user activation of a flush control. For example, in certain embodiments, two adjacent interventional devices can be moved relative to one another in response to control signals from a control system. In certain embodiments, delivery of pressurized fluid can be performed in response to control signals from the control system.

[0203] The reciprocating motion of adjacent catheters can generate shear forces that dislodge air bubbles. For example, relative movement of the inner and outer surfaces of adjacent catheters can increase the fluid shear rate between adjacent catheters during priming compared to static surfaces. In some embodiments, the shear forces can be increased by increasing the flow rate of the solution (e.g., saline, contrast medium, or a mixture of saline and contrast medium) being provided by the fluidics system. In certain embodiments, both the flow rate and the relative movement between adjacent catheters are controlled to dislodge air bubbles.

[0204] In some embodiments, after each catheter is primed by the fluidics system, an ultrasonic bubble detector can be used to verify that the catheter is substantially free of air bubbles. For example, an ultrasonic tip (e.g., mounted in a hub adjacent to the catheter receiving lumen) can be run along the length of the catheter to verify that no air bubbles remain in the system.

[0205] An example of a priming process involving reciprocating adjacent catheters is described with respect to Figures 23A-23B.

[0206] 23A depicts an interventional device assembly 2900 assembled in a concentric stack configuration. As shown in FIG. 23A, the interventional devices can be fully nested within one another. This can be the configuration following unpackaging and placement of the device assembly 2900 on a robotic drive table. Alternatively, the individual interventional devices of the device assembly 2900 can be assembled into the device assembly 2900 on the drive table.

[0207] The priming sequence can begin by priming catheter 2906. In some embodiments, catheter 2906 can be primed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2906 while causing reciprocating movement of catheter 2906 and / or hub 2914 axially, rotationally, or both relative to catheter 2906. Priming catheter 2906 can include priming hub 2914. For example, in certain embodiments, hub 2914 or a hemostasis valve coupled thereto can include a fluidic connection for receiving priming fluid from the fluidics system. In certain embodiments, catheter 2906 and / or hub 2914 can be axially agitated back and forth along the longitudinal axis of catheter 2906 (e.g., between the positions of FIGS. 23A and 23B ). The axial and / or rotational reciprocating movement of catheter 2906 and / or hub 2914 can be performed manually or by a robotic drive table. The reciprocating movement can occur in response to control signals from a control system. The introduction of fluid under pressure can be performed in response to control signals from the control system.

[0208] In some embodiments, priming of catheter 2906 can be performed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2906 while causing reciprocating movement of catheter 2904 and / or hub 2912 axially, rotationally, or both relative to catheter 2906. The axial and / or rotational reciprocating movement of catheter 2904 and / or hub 2912 can be performed manually or by a robotically driven table. The reciprocating movement can be caused in response to a control signal from a control system. The introducing of fluid under pressure can be performed in response to a control signal from a control system.

[0209] In some embodiments, priming of catheter 2906 can be performed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2906 while causing reciprocating movement of both catheter 2906 (and / or hub 2914) and catheter 2904 (and / or hub 2912) axially, rotationally, or both relative to one another. The reciprocating movement can be caused in response to a control signal from a control system. The introducing of the fluid under pressure can be performed in response to a control signal from a control system.

[0210] In some embodiments, after priming the catheter 2906, the catheter 2906 can be returned to an initial position, as shown in Figure 23 A. In other embodiments, after priming the catheter 2906, the catheter 2906 can be advanced to a ready or actuated position to begin insertion into the patient.

[0211] In some embodiments, catheter 2904 can be primed after catheter 2906 is primed. Priming catheter 2904 can include priming hub 2912. For example, in certain embodiments, hub 2912 or a hemostasis valve coupled thereto can include a fluidic connection for receiving a priming fluid from a fluidics system. In some embodiments, catheter 2904 can be primed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2904 while causing reciprocating movement of catheter 2904 and / or hub 2912 axially, rotationally, or both relative to catheter 2906. The reciprocating movement can be caused in response to a control signal from a control system. Introducing the fluid under pressure can be performed in response to a control signal from a control system.

[0212] In some embodiments, priming of catheter 2904 can be performed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2904 while causing reciprocating movement of catheter 2902 and / or hub 2910 axially, rotationally, or both relative to catheter 2904. The axial and / or rotational reciprocating movement of catheter 2902 and / or hub 2910 can be performed manually or by a robotically driven table. The reciprocating movement can be caused in response to a control signal from a control system. The introducing of the fluid under pressure can be performed in response to a control signal from a control system.

[0213] In some embodiments, priming of catheter 2904 can be performed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2904 while causing reciprocating movement of both catheter 2904 (and / or hub 2912) and catheter 2902 (and / or hub 2910) axially, rotationally, or both relative to one another. The reciprocating movement can be caused in response to a control signal from a control system. The introducing of the fluid under pressure can be performed in response to a control signal from a control system.

[0214] In some embodiments, after priming the catheter 2904, the catheter 2904 can be returned to an initial position, as shown in Figure 23 A. In some embodiments, after priming the catheter 2904, the catheter 2904 can be advanced to a ready or actuated position to begin insertion into the patient.

[0215] In some embodiments, catheter 2902 can be primed after catheter 2904 is primed. Priming catheter 2902 can include priming hub 2910. For example, in certain embodiments, hub 2910 or a hemostasis valve, three-way valve, or other fluid control valve coupled thereto can include a fluidic connection for receiving priming fluid from a fluidics system. In some embodiments, catheter 2902 can be primed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2902 while causing reciprocating movement of catheter 2902 and / or hub 2910 axially, rotationally, or both relative to guidewire 2907. The reciprocating movement can be caused in response to a control signal from a control system. Introducing the fluid under pressure can be performed in response to a control signal from the control system.

[0216] In some embodiments, priming of catheter 2902 can be performed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2902 while causing reciprocating movement of guidewire 2907 and / or hub 2909 axially, rotationally, or both relative to catheter 2902. The axial and / or rotational reciprocating movement of guidewire 2907 and / or hub 2909 can be performed manually or by a robotically driven table. The reciprocating movement can be caused in response to a control signal from a control system. The introducing of the fluid under pressure can be performed in response to a control signal from the control system.

[0217] In some embodiments, priming of catheter 2902 can be performed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2902 while causing reciprocating movement of both catheter 2902 (and / or hub 2910) and guidewire 2907 (and / or hub 2909) axially, rotationally, or both relative to one another. The reciprocating movement can be caused in response to a control signal from a control system. The introducing of the fluid under pressure can be performed in response to a control signal from the control system.

[0218] In some embodiments, after priming the catheter 2902, the catheter 2902 can be returned to an initial position, as shown in Figure 23 A. In other embodiments, after priming the catheter 2902, the catheter 2902 can be advanced to a ready or actuated position to begin insertion into the patient.

[0219] 23A and 23B can be performed in response to a single control signal from the control system. In other embodiments, various steps of the priming procedure can be performed in response to unique control signals. In some embodiments, the priming of each unique interventional device can be performed in response to a unique control signal.

[0220] 23A and 23B, the catheters are primed in order, starting with catheter 2906, followed by catheter 2904, and then catheter 2902. However, it is contemplated that the catheters may be primed in any order. The catheters may be primed serially as described above with respect to FIGS. 23A and 23B. Alternatively, two or more of the catheters, or each of the catheters, may be primed in parallel.

[0221] In certain embodiments, priming the catheter can include reducing the depth of axial insertion (i.e., axial overlap) of a second interventional device into the lumen of a first interventional device through which fluid is to be injected (e.g., the length of the second interventional device into its concentrically adjacent lumen), as described with respect to Figures 22A-22C, and also generating relative reciprocating movement between the first interventional device and the second interventional device, axially, rotationally, or both, during priming, as discussed with respect to Figures 23A and 23B.

[0222] Fluidics management system and method 26A illustrates one embodiment of one channel of a multi-channel fluidics management system 2600. The fluidics management system 2600 can be configured as an automated system for managing the delivery of fluids to or the withdrawal of materials from a patient via one or more interventional devices (e.g., catheters). As shown, the system 2600 can manage fluid delivery to a patient during a medical procedure. The fluidics management system 2600 includes at least one fluid source and / or sink 2612 coupled to a valve 2614, which is coupled to a manifold 2616. The manifold 2616 is either remote (e.g., on a support table or tower outside the sterile field) or coupled to a catheter hub 2618, which is coupled to at least one source and / or sink line 2116. The source and / or sink line 2116 is coupled to at least one catheter 120 through the hub 2618.

[0223] In some embodiments, fluid source and / or sink 2612 includes both a reservoir of fluid volume and a means for propelling such fluid to another component of system 2600 or a means for withdrawing fluid back to the source. Exemplary propelling means can include one or more propellers, impellers, syringes, and / or pumps for circulating and / or withdrawing fluid throughout system 2600. In some embodiments, the propelling means can be used to control volume, flow rate, and / or pressure. In certain embodiments, the propelling means can be activated to propel fluid to another component of the system or to withdraw fluid from the system, or can be deactivated to stop fluid movement.

[0224] In some embodiments, the fluidics management channels are substantially replicated for each catheter configured for use in a particular medical procedure. Different channels may differ with respect to the sensors, pumps, and / or valves employed based on the interventional device connected to each fluidics channel. For example, a fluidics system for a treatment catheter (e.g., for aspiration) may include an in-line vacuum pump and filter. Furthermore, a fluidics system for a guide catheter, access catheter, or insertion catheter, for example, may include an in-line drip rate sensor, air bubble sensor, pressure sensor, and / or air bubble filter.

[0225] Sources and / or sinks 2612 represent either fluid sources or fluid sinks (e.g., waste canisters). For example, a fluid source can include a container adapted to hold a fluid (e.g., saline, contrast, medication, blood, plasma, or other fluid) for use by the fluidics management system 2600. The container can be configured to release the fluid into a fluid delivery line (e.g., fluid delivery tubing) using active means (e.g., a pump, vacuum, etc.) or passive means (e.g., gravity). A fluid sink can include a container adapted to accept fluid (e.g., aspirate, clot, particles, saline, contrast, medication, blood, or other fluid, or a combination thereof) from a patient and / or from other fluidics infrastructure within the fluidics management system 2600.

[0226] Valve 2614 represents one or more valves coupled to a source and / or sink 2612 on a first side of the valve 2614 and coupled to a manifold 2616 on a second side of the valve 2614. The manifold 2616 is configured to connect each valve 2614 to a specific hub 2618. In some embodiments, the valves 2614 can instead be coupled directly to the hub 2618 to avoid the use of a separate manifold 2616. In some embodiments, the manifold 2616 can be integrated into the hub. In some embodiments, a second valve 2614 can connect the manifold 2616 to the hub 2618. For example, the second valve 2614 can be coupled to the manifold 2616 on a first side and to the hub 2618 on a second side.

[0227] The hubs 2618 are configured to be releasably or non-releasably coupled to an interventional device (catheter, guidewire, guiding element, or other medical device). For example, the catheter 120 has a proximal end attached to its own hub 2618 (sometimes referred to as a "puck"). In some embodiments, the hub 2618 is movable along a path along the surface of a robotic table to advance or retract the catheter 120 (or other medical and / or interventional device). Each hub 2618 can also contain mechanisms for rotating or deflecting the catheter 120 or guidewire as desired. The hubs 2618 can be connected to fluid delivery tubing (e.g., source / sink lines 2116) to provide fluid release or fluid capture. Each hub 2618 can be in electrical communication with an electronic control system via either a hardwired connection, an RF wireless connection, or a combination of both. Additional details of the hub, drive table, and associated systems can be found in U.S. patent application Ser. No. 17 / 816,669, entitled "Method of Supra-Aortic Access for a Neurovascular Procedure," filed August 1, 2022, which is expressly incorporated by reference in its entirety into this specification.

[0228] Any of the hubs disclosed herein can further include one or more fluid injection ports and / or a wireless RF transceiver for communication and / or power transfer. In some embodiments, the hub 2618 can also include wired electrical communication and power ports.

[0229] In some embodiments, the hub 2618 or the line 2116 leading to the hub 2618 can include a visual indicator to indicate the presence of an aspirated clot. The visual indicator can include a clot chamber having a transparent window. A filter can be provided within the clot chamber. Additional details of the clot capture filter and related features can be found in U.S. Provisional Patent Application No. 63 / 256,743, entitled "Device for Clot Retrieval," filed October 18, 2021, which is expressly incorporated herein by reference in its entirety.

[0230] Any of the hubs or interventional devices disclosed herein can further include sensors for detecting parameters of interest, such as the location or orientation of the distal tip or the status of the distal tip of the interventional device. The status of the distal tip can include, but is not limited to, detecting interaction between the vessel wall and the distal tip, detecting interaction between the vessel wall and a clot, or detecting an unobstructed distal tip. In some cases, the sensors can be positioned on the flexible body of the interventional device. The sensors can include a pressure sensor for capturing arterial blood pressure waveforms at the distal end of the catheter or an optical sensor for determining trapped clots or air bubbles. In some embodiments, the sensors can include one or more of a force sensor, a positioning sensor, a temperature sensor, a torque sensor, a strain sensor, and / or an oxygen sensor. In some embodiments, the sensors can include a fiber Bragg grating sensor. For example, a fiber Bragg grating sensor (e.g., an optical fiber) can locally detect strain, which can facilitate detection and / or determination of applied force.

[0231] 26B-43 illustrate schematic diagrams of multi-channel fluidics systems, parts of multi-channel fluidics systems, or the operation of multi-channel fluidics management systems. These fluidics systems, along with other systems (e.g., drive systems) and components described herein, can provide fluid to a target site in a patient's vasculature through one or more catheters. For example, these systems can include a catheter having a tubular catheter shaft having a proximal end, a distal end, and a lumen defined by an inner surface of the catheter shaft extending longitudinally through the catheter shaft between the proximal and distal ends. These systems can also include a guiding element having a distal end, a proximal end, and an outer surface configured to be positioned within the lumen of the catheter to create a predetermined area between the outer surface of the guiding element and the inner surface of the catheter, the area having an effective cross-sectional area for fluid communication of a specific amount of fluid at a specific pressure. In some embodiments, the effective cross-sectional area is equal to or greater than 0.001257 square inches, which allows a desired amount of fluid (e.g., contrast medium) to flow through the lumen when the guiding element is positioned within the lumen, providing a desired volume of fluid. For example, the system can include a contrast pump coupled to the catheter in fluid communication with the lumen. The system is configured to receive a signal to activate the contrast pump, and provide contrast medium into the proximal end of the catheter at a pump pressure less than or equal to about 400 psi while the guiding element is at least partially positioned within the lumen of the catheter, such that the provided contrast medium propagates along the exterior surface of the guiding element, through the lumen of the catheter, and exits the distal end of the catheter. The effective cross-sectional area allows a predetermined flow rate of contrast medium (e.g., at least about 3 cc per second) out of the distal end of the catheter.For example, the contrast medium may have a viscosity ranging from greater than 1 cP to about 30 cP. That is, the contrast medium may have a viscosity of greater than 1 cP, or may have a viscosity of about 2 cP, 2 cP, 4 cP, 5 cP, 6 cP, 7 cP, 8 cP, 9 cP, 10 cP, 11 cP, 12 cP, 13 cP, 14 cP, 15 cP, 16 cP, 17 cP, 18 cP, 19 cP, 20 cP, 21 cP, 22 cP, 23 cP, 24 cP, 25 cP, 26 cP, 27 cP, 28 cP, 29 cP, or 30 cP, plus or minus 0.5 cP. While having an effective cross-sectional area is important for any fluid, it is generally most important for viscous fluids, such as contrast media, which may require high pressures to communicate through a catheter lumen.

[0232] 26B illustrates a schematic diagram of a multi-channel fluidics management system 2610 having a first source 2612a, a second source 2612b, and a sink 2612c. The first source 2612a is coupled to a valve 2614a. The second source 2612b is coupled to a valve 2614b. The sink 2612c is coupled to a valve 2614c. The valves 2614a, 2614b, and 2614c are part of a valve manifold 2616. The valve manifold 2616 is coupled to a hub 2618. In certain embodiments, the valve manifold 2616 is part of or directly connected to the hub 2618. In other embodiments, the valve manifold 2616 is positioned remotely from the hub 2618 and is connected to the hub 2618 via one or more fluid lines. In other embodiments, the valve manifold is part of or directly connected to the hemostasis valve. In other embodiments, the valve manifold 2616 is positioned remotely from the hemostasis valve and connected to the hemostasis valve via one or more fluid lines. Valves 2614a, 2614b, and 2614c can be opened and closed to selectively place the first fluid source 2612a, the second fluid source 2612b, and the sink 2612c in communication with the lumen of the catheter 120. For example, the valve manifold 2616 can include fluid ports (e.g., a first port 2615a associated with valve 2614a, a second fluid port 2615b associated with valve 2614b, and a third port 2615c associated with valve 2614c) that can be selectively placed in communication with or out of communication with the lumen of the catheter 120. For example, in some embodiments, one of the first port, the second port, and the third port can be placed in communication with the lumen of the catheter 120, while the other two ports are blocked from communication with the catheter 120.

[0233] In certain embodiments, first source 2612a can be a source of heparinized saline. Source 2612b can be a source of contrast agent solution. In certain embodiments, one or more of sources 2612a, 2612b, and 2612c can be coupled to multiple manifolds 2616, each coupled to a unique interventional device 2618. Valve manifolds 2616 such as those shown herein can be utilized in any of the systems described herein.

[0234] 27 illustrates a schematic diagram of a three-channel fluidics system 2700 for use with the fluidics management system 2600, which includes a stack of four concentrically arranged interventional devices. The fluidics system 2700 shown here includes a fluid management portion 2702 and an interventional portion 2704. In some embodiments, the interventional portion 2704 can include a concentric catheter and guidewire stack configured for manual manipulation by a physician. In some embodiments, the interventional portion 2704 can include a concentric catheter and guidewire stack configured for manipulation by a robotically driven system. In some embodiments, the interventional portion 2704 includes a combination of both robotically driven and manually operated medical devices.

[0235] The components of the fluid management portion 2702 can be positioned outside of the sterile field or within the sterile field, in some embodiments, the fluid management portion 2702 is positioned outside of the sterile field but is connected to the interventional portion 2704 (which is positioned within the sterile field) by flexible tubing and flexible electrical conductors.

[0236] Fluid management portion 2702 can include at least two or more channels (e.g., parallel channels) of the type shown in FIG. 26A, each for a separate fluid source or fluid sink. In the illustrated embodiment, fluid management portion 2702 includes three channels, each in communication with one of three catheters via a corresponding catheter hub. Two channels provide delivery of two separate fluids to each of the catheters, each with a controllable pressure, volume, and delivery rate. A third channel provides suction from each catheter into a sink.

[0237] Each of the two or more fluid channels can be primed by completely degassing and filling with the respective fluid so that it is ready for delivery into the catheter and into the body cavity. In some embodiments, the fluid lines, catheter, and / or catheter lumens can be simultaneously flushed and primed with a fluid (e.g., saline).

[0238] In some embodiments, systems 2700, 2800 can be configured to backfill each sink connection to each catheter with a fluid (e.g., saline) during treatment initialization and / or between fluidics steps. This can provide a column of backfilled saline downstream of the sink connection, ensuring, for example, that contrast injection flows to the distal tip of a particular catheter and not to the sink. In some embodiments, systems 2600, 2700 can be configured to provide a column of backfilled saline upstream of a saline valve at the hub, ensuring, for example, that contrast injection flows to the distal tip of a particular catheter or to the sink without passing through the saline valve.

[0239] 27, fluid management portion 2702 of fluidics system 2700 includes first supply 2710a, second supply 2710b, and sink 2712. Sources 2710a and 2710b can each be configured to hold and dispense at least one fluid (e.g., saline, contrast, medication, blood, or other fluids, or a combination thereof). Sink 2712 can be configured to accept waste fluids and / or waste products from a selected aspiration line leading to a corresponding catheter. While two fluid sources and one fluid sink are shown, any number of fluid sources and / or fluid sinks are possible (e.g., one fluid source and one fluid sink, two fluid sources with no fluid sink, three or more fluid sources, etc.) depending on the fluid delivery and / or aspiration needs of a particular procedure.

[0240] A plurality of valves (and / or valve arrays) are provided for stopping and starting the flow of respective fluids to or through one or more fluid lines and / or hubs in sections 2702 and / or 2704. In the illustrated implementation, a first valve array 2716a (e.g., comprising three valves) is carried by a first manifold 2718a, a second valve array 2716b (e.g., comprising three valves) is carried by a second manifold 2718b, and a third valve array 2716c (e.g., comprising three valves) is carried by a third manifold 2718c. While a valve array comprising three valves is shown, any number of valves is possible, and can correspond to the number of catheters and / or fluid sources used in the procedure or the number of subsets of interventional devices used in the procedure. For example, in some situations, each valve array can include at least one valve, two valves, three valves, or four or more valves.

[0241] In some embodiments, each valve in a valve array (e.g., valve array 2716a) can be configured to independently control and / or adjust the fluid resistance, flow rate, and / or pressure of the fluid flowing through the valve and corresponding tubing. In some embodiments, each valve in a valve array can be independently and / or simultaneously adjusted for each catheter and / or for two or more catheters.

[0242] In the illustrated implementation, the fluidics channels are duplicated for each catheter and will therefore only be described in relation to source 2710a below. A first outlet valve 2717a communicates with a first catheter 2726 by a unique source line 2720a. A second outlet valve 2717b communicates with a second catheter 2728 by a unique source line 2720b. A third outlet valve 2717c communicates with a third catheter 2730 by a unique source line 2720c. Each valve 2717a-2717c is preferably electronically actuated between a fully closed, fully open, or partially open position in response to a signal from a control system. Any of a variety of valve mechanisms can be utilized, such as ball valves driven by stepper motors, solenoids, stopcock valves (e.g., rotary stopcock valves), rotary valves, or other actuation mechanisms known in the art. The drive mechanism can provide automated control and sequencing of the valves. For example, valve actuation can be achieved using stepper motors with built-in encoding to provide consistent switching and sequencing. The drive mechanism can be controlled using a motor controller in a user control interface (e.g., or computer system). The control system can include a module that reads values ​​from sensors (e.g., flow, bubble, pressure, etc.) and displays the values ​​to control the behavior of the fluid system.

[0243] In some embodiments, stopcock valve mechanisms (e.g., rotary stopcock valves) can be used in the manifolds described herein. For example, one or more stopcock valves can be located adjacent to (or integrated into) the hub to avoid managing the fluid column in a particular tubing. Such tubing can be sterile, disposable tubing that can be provided for single use. Installing a manifold with stopcock valves near or integrated into the hub has the advantage of simplicity, without the need to manage the fluid column in the tubing. Having the manifold and stopcock valves remote from the hub can allow both the manifold and stopcock valves to be used outside the sterile field with non-sterile equipment. Such a configuration can provide the advantage of preserving the sterility of components within the sterile field.

[0244] In some embodiments, the fluidics control system can further include a drive mechanism configured to adjust the sealing strength of the hemostasis valve in response to a signal from the control system (e.g., from a processor of the control system). The control system (e.g., processor) can be configured to increase the sealing strength of the hemostasis valve in response to operating the contrast control to introduce contrast into the catheter. The control system (e.g., processor) can additionally be configured to decrease the sealing strength of the hemostasis valve in response to operating the contrast control to stop introducing contrast into the catheter. In some embodiments, the control system (e.g., processor) can be configured to decrease the sealing strength of the hemostasis valve in response to a signal received to drive a catheter or guidewire through the hemostasis valve. Such a feature can provide the advantage of, for example, reducing friction between the hemostasis valve and a moving catheter shaft.

[0245] In operation, all three valves 2717a-2717c can be in an open configuration to allow saline to flow through each of the three catheters. The forward flow of saline (flow in the direction of arrow 2722a) can be driven by pump 2714 (e.g., an electronically controlled peristaltic infusion pump or a rotary piston pump, etc.). Alternatively, any one of the valves can be open with the other two closed, depending on the desired performance. Alternatively or additionally, other sources of volume and / or pressure (e.g., pump 2714) can be deactivated or disconnected to prevent flow.

[0246] In the concentric catheter stack illustrated in FIG. 27, the first catheter 2726 can be a "large bore" guide catheter having an inner diameter of at least about 0.075 inches or at least about 0.080 inches. The second catheter 2728 can be an aspiration catheter having an inner diameter in the range of about 0.060 inches to about 0.075 inches. The third catheter 2730 can be an access catheter. In one example, the access catheter is a steerable catheter with a deflectable distal tip having an inner diameter in the range of about 0.025 inches to about 0.050 inches (in one example, an inner diameter in the range of about 0.045 inches to about 0.049 inches). The guidewire 2732 can have an outer diameter in the range of about 0.014 inches to about 0.020 inches. In one particular example, the first catheter can have a diameter of about 0.088 inches, the second catheter can have a diameter of about 0.071 inches, the third catheter can have a diameter of about 0.035 inches, and the guidewire can have a diameter of about 0.018 inches.

[0247] The available lumen in the first catheter 2726 is the difference between the inner diameter (ID) of the first catheter 126 and the outer diameter (OD) of the second catheter 2728. It can be different from the available lumen in the second catheter 2728 (which can be the difference between the ID of the second catheter 2728 and the OD of the third catheter 2730), and it can be different from the available lumen in the third catheter 2730 (which can be the ID of the third catheter 2730 or the difference between the ID of the third catheter 2730 and the OD of the guidewire 2732). To produce the same delivered infusion flow rate through each of the catheters, the control system can be configured to adjust the pump 2714 and / or each of the valves 2717a-2717c to compensate for the difference in the effective cross-section of the respective flow paths to achieve the same delivered flow rate through each catheter. The system can use parameter files associated with attached devices (catheters and guidewires), the parameter files containing dimensional information for the devices (e.g., ID, OD, length), and can adjust the pump based on the dimensional information and information about the fluid being communicated inside the catheter (e.g., density and / or viscosity of the contrast medium being communicated through the catheter lumen).

[0248] In one implementation of the invention, the catheters can be assembled into the concentric stack orientation shown in FIG. 27 and air removed by replacing the air with a fluid (e.g., saline) prior to flushing the catheters. This is preferably accomplished in each fluid lumen (e.g., the annular lumen between the first catheter 2726 and the second catheter 2728) and between each of the additional concentric interventional devices in the stack orientation. Infusing saline under pressure can replace substantially all of the air, although some small bubbles may remain, for example, adhering to the inner wall of the first catheter 2726, the outer wall of the second catheter 2728, or both.

[0249] While saline is introduced under pressure into the proximal end of the annular lumen between the two interventional devices (e.g., the annular lumen between the first catheter 2726 and the second catheter 2728), the inner catheter can be moved relative to the outer catheter (e.g., the second catheter 2728 can be moved relative to the outer catheter), breaking the holding forces between the microbubbles and the adjacent wall and allowing the bubbles to be carried downstream and exit through the distal opening of the lumen. The catheters can be moved axially, rotationally, or both relative to each other. In one implementation, the first catheter is reciprocated relative to an adjacent catheter or guidewire, e.g., axially over a range of about 0.5 inches to about 10 inches, or about 1 inch to about 5 inches, at a reciprocating frequency of about 5 cycles per second or less, or 2 cycles per second or less.

[0250] Reciprocating movement of adjacent catheters to destroy microbubbles can be accomplished manually by grasping the corresponding catheter hubs and manually moving the catheters axially or rotationally relative to one another while delivering pressurized saline. Alternatively, such as in a robotically driven system, the processor can be configured to robotically drive at least one hub of two adjacent catheters (e.g., at least one of hub 2724a and hub 2724b) to achieve relative movement between the adjacent catheters, thereby destroying and expelling microbubbles, such as in response to user activation of a flush control.

[0251] Source 2710b is in fluid communication with manifold 2718b, allowing fluid to flow to any number (e.g., three) of valves in valve array 2716b, as indicated by arrow 2722b. The forward flow of contrast (flow in the direction of arrow 2722b) can be driven by pump 2736 (e.g., a syringe pump, a high-pressure positive displacement pump, a contrast injection pump, etc.). Any one of the valves in valve array 2716b can be open with the other two closed, depending on the desired performance. Alternatively or additionally, other sources of volume and / or pressure (e.g., pump 2736) can be deactivated or disconnected to prevent flow. The proximal opening of each source line 2721a, 2721b, 2721c can be coupled to a respective output port on a corresponding valve in valve array 2716b. The distal opening of each source line 2721 a, 2721 b, 2721 c can be coupled to a respective hub 2724 a, 2724 b, 2724 c and thus to a corresponding catheter 2726, catheter 2728, and / or catheter 2730. Each catheter 2726, catheter 2728, catheter 2730, and / or guidewire 2732 can be guided into a patient (not shown). Additional hubs and / or catheters can be added to system 2700, and corresponding fluidics management system components (e.g., system 2600) can be added to system 2700. In other embodiments, system 2700 can include fewer hubs and / or catheters, for example, two hubs and / or catheters.

[0252] Sink 2712 is coupled to manifold 2718c to receive fluid from aspiration lines 2723a, 2723b, 2723c in the direction indicated by arrow 2722c. The aspiration lines are configured to receive fluid and embolic material from one, two, or all three respective catheters 126, 128, and 130, depending on input from a physician to the control system. When the physician determines which catheter is to be placed in aspiration mode and activates the corresponding aspiration control, the corresponding valve in valve array 2716c can open, allowing fluid to flow through the corresponding catheter and into sink 2712, in response to the control system activating aspiration pump 2715. Any one of the valves in valve array 2716c can be open with the other two closed, depending on desired performance. Alternatively or additionally, other sources of volume and / or pressure (e.g., pump 2715) can be deactivated or isolated to prevent flow.

[0253] In the exemplary embodiment, fluidics system 2700 represents an aspiration configuration, where source 2710a contains heparinized saline and source 2710b contains a contrast agent solution. Sink 2712 in this example can contain waste blood / saline / embolic material aspirated from a patient (not shown). Other additional sources and / or sinks can also be used in combination with the respective fluids.

[0254] Similarly, contrast solution contained by source 2710b can flow in the direction of arrow 2722b and into manifold 2718b. In a given procedure, a physician can decide to inject contrast through any of the three catheters, and typically through the most distal catheter, at a given injection time. In response to a contrast injection command, the control system will open the valve corresponding to the selected catheter and typically keep the other two valves closed. In some embodiments, a physician can simultaneously inject contrast into two or more catheters. In some embodiments, contrast or suction can be applied simultaneously, for example, while actuating a catheter or guidewire.

[0255] In some embodiments, each valve (or valve array) can be housed within or carried by a respective hub 2724a, 2724b, 2724c. In some embodiments, each valve (or valve array) can be housed adjacent to or remote from a respective hub. In such instances, additional fluid lines (e.g., 2720, 2721, 2723) can be added between each manifold and the corresponding valve. Fluid lines 2720a-c, 2721a-c, and 2723a-c can be tubing. In some embodiments, any of fluid lines 2720a-c, 2721a-c, and 2723a-c can be removably coupled to their respective hubs. Alternatively, any of fluid lines 2720a-c, 2721a-c, and 2723a-c can be permanently connected to the hub and removably coupled to other components of fluid management portion 2702 (e.g., valve arrays 2716a-c or manifolds 2718a-c, etc.).

[0256] In some embodiments, the fluidics system 2700 can also include any number of pressure sensors, volume sensors, flow sensors, tubing sets, connectors, and bubble sensors / detectors, as will be discussed. In the illustrated implementation, a pressure transducer 2734a is in pressure-sensing communication with a first catheter 2726 via a hub 2724a. Additional pressure transducers 2734b, 2734c can be placed in communication with their corresponding catheters, as shown.

[0257] The control system can be configured to automatically adjust the various manifold valves, pumps, and hemostasis valves (discussed below) in response to commands entered by the physician. For example, the physician may enter a command to infuse contrast through the third catheter 2730. The control system can automatically initiate a series of response events. At a minimum, saline valve 2717c will close. Valves 2717a and 2717b can be closed or can remain open, providing positive pressure through the first and second catheters and preventing backflow of contrast.

[0258] A control signal is sent to the hemostasis valves in each of the first and second catheter hubs 2724a and 2724b to clamp down from a low pressure sliding fit to a high pressure clamp around the second and third catheters 2728 and 2730, respectively. This will prevent contrast from escaping proximally through the first and second catheters 2726 and 2728. A control signal is additionally sent to valve 2719c to place the third catheter 2730 in fluid communication with a second source 2710b containing the contrast solution.

[0259] If the space between the OD of guidewire 2732 and the ID of third catheter 2730 is insufficient to allow the desired contrast infusion rate, a further signal will be sent from the control system to the drive system controlling hub 2724d to retract guidewire 2732 proximally from third catheter 2730 a sufficient distance to allow contrast flow through catheter 2730. An additional control signal can be sent to a hemostasis valve carried by hub 2724c to clamp around a distal portion of guidewire 2732 in a high pressure mode, or into a fully closed configuration if guidewire 2732 is fully retracted. A further control signal can be sent to an electronically activated high pressure pump 2736 (e.g., a syringe pump, a high pressure positive displacement pump, a contrast injection pump, etc.) to deliver the contrast solution through third catheter 2730.

[0260] If the physician initiates a command to perform suction through first catheter 2726, for example, the control system can automatically send another series of control signals to carry out the command. A signal is sent to each of the hemostasis valves to move them from a high-pressure configuration to a low-pressure configuration, which generates less friction against the catheter shaft or guidewire. Such a configuration can allow relative movement of the various devices and proximal retraction of second catheter 2728 and third catheter 2730 from first catheter 2726 while still limiting proximal blood loss through the hemostasis valves. A signal is sent to the drive system to proximally retract each of hubs 2724b, 2724c, and 2724d. Valve 2716c will be opened to place first catheter 2726 in fluid communication with sink 2712. A signal will be sent to activate vacuum pump 2715, thereby aspirating blood and clots into sink 2712. In some embodiments, for example, when performing aspiration of first catheter 2726, communication between catheter 2726 and first fluid source 2710a and second fluid source 2710b can be blocked. For example, corresponding valves in valve arrays 2716a and 2716b can be closed to block manifolds 2718a and 2718b. Alternatively, volume and / or pressure sources (e.g., pumps 2714 and 2736) can be deactivated or disconnected.

[0261] All of the fluid lines between the first and second sources 2710a and 2710b and each of the catheters, as well as the sink 2712 and each of the catheters, are preferably completely flushed free of bubbles and filled with fluid (e.g., saline, etc.) during pre-treatment system preparation. This allows for seamless transitions between infusion, aspiration, and catheter and guidewire manipulation without the need to disconnect and reconnect any fluid lines between the sources, sinks, and catheters, eliminating the risk of introducing air emboli during such exchanges.

[0262] It may also be desirable to be able to confirm that no bubbles are present in any of the fluid lines. This can be achieved by placing bubble sensors in proximity to each of the fluid lines (e.g., in or upstream of each of the hubs, or in the manifold, etc.). This may be particularly desirable in telemedicine applications, where the physician is at a remote workstation and out of direct line of sight with the patient.

[0263] This can be accomplished using a non-contact ultrasonic sensor that measures the intensity and Doppler shift of reflected ultrasound through the sidewall of the fluid tubing to detect bubbles and measure fluid flow or level. The ultrasonic or optical sensor can be positioned adjacent to the incoming fluid flow path in the hub or in the supply line leading to the hub.

[0264] For example, to detect the presence of air bubbles in an infusion line (which is formed from an ultrasonically or optically transparent material), the sensor can include a signal source on a first side of the flow path and a receiver on a second side of the flow path to measure transmission through the liquid passing through the tubing to detect the bubble. Alternatively, the reflected ultrasound signal can be detected from the same side of the flow path as the source due to the relatively high echogenicity of the bubble.

[0265] Alternatively, an optical sensor can be provided to detect changes in optical transmittance or reflectance due to the presence of a bubble, or to send a visual signal to a display at a remote workstation where a physician can visually observe the presence of a bubble traveling through the tubing. In systems with a bubble detector, the control system can be configured to automatically shut down all fluid flow in response to detecting a bubble, allowing personnel an opportunity to plan next steps.

[0266] In one implementation, the bubble removal system is automatically activated upon detection of an in-line bubble. The processor can be configured to activate a valve positioned in the flow path downstream of the bubble detector upon detection of a bubble. The valve diverts the column of fluid containing the detected bubble from the flow path leading to the patient into a bypass flow path or a reservoir instead. Once 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 source of fluid with the patient through the flow path. In some embodiments, the flow path can include any number of bubble filters and / or traps to remove bubbles from the flow path.

[0267] Robotic system portion 2704 can include a drive table configured to accept (e.g., couple to) any number of hubs (2724a, 2724b, 2724c, 2724d, etc.). Additional details of the hubs, drive tables, and associated systems can be found in U.S. patent application Ser. No. 17 / 816,669, entitled "Method of Supra-Aortic Access for a Neurovascular Procedure," filed Aug. 1, 2022, which is expressly incorporated herein by reference in its entirety. Each hub is configured to couple to a catheter or guidewire, one or more fluidics lines, one or more electrical lines, one or more controls, and / or one or more displays. For example, a drive table can be positioned on or near a patient and can be configured to support axial advancement, retraction, and in some cases rotational and / or lateral deflection of two or three or more different (e.g., concentrically or side-by-side oriented) devices (e.g., catheters, guidewires, etc.).

[0268] The drive system independently drives the movement of each hub in a proximal or distal direction across the table surface to move the corresponding interventional device (e.g., catheter 2726, catheter 2728, catheter 2730, and / or guidewire 2732) proximally or distally within the patient's vasculature.

[0269] Respective catheters 2726, 2728, 2730, and / or guidewire 2732 can be guided into a body cavity (not shown) as a single concentric catheter stack in response to movement of respective hubs 2724a, 2724b, and 2724c, as discussed elsewhere herein. System 2700 can also include guidewire hub 2724d for controlling guidewire 2732, which can also be introduced into the body cavity along with one or more of catheters 2726, 2728, and / or 2730.

[0270] In some embodiments, a driven magnet is provided on each hub. Each driven magnet is configured to cooperate with a drive magnet associated with the table such that the driven magnet moves in response to movement of the drive magnet. In such an example, the drive magnet can be axially movably carried by the support table.

[0271] Because multiple sources and / or sinks are configured to be coupled (and remain coupled) to each catheter hub (e.g., hubs 2724a, 2724b, and 2724c), fluidics system 2700 provides the advantage of enabling faster treatment than conventional fluidics systems that utilize manual removal, addition, and / or switching of fluids, catheters, hubs, etc., during a treatment. For example, fluidics system 2700 allows each fluid line / catheter hub to be connected to its respective source fluid and / or sink before beginning a treatment. When the interventionalist (or other medical personnel) performing the treatment is ready to use a particular source fluid or sink, system 2700 is already configured and ready to enable use of the particular source fluid or sink without having to switch between different fluid lines for a particular catheter. In some embodiments, system 2700 can be used to provide a method of treatment that does not require a fluid source to be connected and / or disconnected from a medical device multiple times during a treatment.

[0272] Thus, because each catheter hub 2724a, 2724b, 2724c is always provided with access to all fluid lines, the interventional physician can inject any of the fluids contained in the fluid sources 2710a, 2710b and / or collect aspirate from any of the catheters 2726, 2728, and / or 2730 at any time during the procedure.

[0273] Because multiple fluid sources indicated for a particular procedure are pre-configured to connect to their respective catheters / catheter hubs, the interventionalist (or other medical personnel) can be confident that they will not repeatedly connect and disconnect syringes or other source fluid containers, fluid lines, etc. during the procedure. This confidence eliminates the possibility of introducing bubbles into the catheter flow during the procedure, since connecting or disconnecting fluid sources is not necessary with the use of system 2700. Instead, each fluid source and sink is connected and tested prior to the procedure and is not removed until after the procedure is completed. In some embodiments, the constant connection of fluid sources and sinks to the catheter hubs associated with the operation of system 2700 eliminates the variability and risk in remote procedures where the interventionalist is in a control room rather than a procedure room.

[0274] The valves in valve arrays 2716a, 2716b, and / or 2716c of system 2700 are depicted in respective manifolds 2718a, 2718b, and 2718c. In such a configuration, the valves are near their respective sources and / or sinks, with about 2 meters to about 3 meters (e.g., about 6 feet to about 10 feet) of fluid line between the valves in valve arrays 2716a, 2716b, and 2716c and their respective catheter hubs 2724a, 2724b, and 2724c. In some embodiments, the valves in valve arrays 2716a, 2716b, and / or 2716c can instead be located at the source / sink (e.g., 2710a, 2710b, and / or 2712). In some embodiments, valve arrays 2716a, 2716b, and / or 2716c are coupled to fluid lines at locations between the source / sink and the hub. In some embodiments, valve arrays 2716a, 2716b, and / or 2716c can be positioned at catheter hubs 2724a, 2724b, and / or 2724c. In some embodiments, valves positioned at or near the hubs can be disposable valves. Other components of systems 2700, 2800 can also be disposable and / or reprocessable for reuse.

[0275] In some embodiments, system 2800 can additionally include valves 2713a-2713i between valve arrays 2716a, 2716b, and 2716c and respective hubs 2724a, 2724b, and 2724c. Valves 2713a-c can be part of hub 2724a or part of a valve manifold (e.g., valve manifold 2616 in FIG. 26B ) coupled (directly or indirectly) to hub 2724a. Valves 2713d-f can be part of hub 2724b or part of a valve manifold (e.g., valve manifold 2616 in FIG. 26B ) coupled (directly or indirectly) to hub 2724b. Valves 2713g-i can be part of hub 2724c or part of a valve manifold (such as, for example, valve manifold 2616 in FIG. 26B) that is coupled (directly or indirectly) to hub 2724c. Valves 2713a-i can be one-way check valves. As shown in FIG. 27, one-way check valves 2713a-i can allow flow in the direction their respective arrows are pointing.

[0276] Each hub 2724a, 2724b, and 2724c can be provided with a hemostatic valve to accommodate the introduction of another device therethrough, as shown in Figure 28. The hemostatic valve includes an aperture of variable diameter, such as an aperture through an elastomeric gasket.

[0277] The gasket may be actuable between a first, fully open state; a second, partially open state for sealing against low-pressure fluid injection from a first fluid source or a second fluid source through the first port (as described herein) to allow fluid to flow through the first port to a sink while allowing the interventional device to be advanced or retracted; and a third, tightly closed state for resisting backflow of high-pressure fluid (e.g., contrast medium) injection from the second fluid source through the first port or for allowing fluid flow through the first port to a sink. The gasket may be manually or automatically actuable, for example, based on user input corresponding to operation of one or more of the interventional devices of the system.

[0278] FIG. 28 illustrates another embodiment of a fluidics system 2800 for use with a fluidics management system. Generally, the fluidics system 2800 includes two or more fluid channels that feed one or more fluid lines configured to interface with a rotary hemostasis valve. The two or more fluid channels can receive fluid from fluid sources with any number of fluid materials. The two or more fluid channels can allow different fluid materials provided by different fluid sources (at various volumes and / or under different pressures) to flow into or out of a body cavity. Each of the two or more fluid channels can be primed with a respective fluid to make it ready for delivery into a single fluid line and into the body. Valves and / or valve arrays can be used to switch between the usage of the two or more fluid channels.

[0279] As shown in FIG. 28 , the fluidics system 2800 can include a vacuum chamber and / or controller 2802 within a sterile field. The vacuum chamber can have a clot filter with a window for visualization of trapped clots and a valved vent that, when momentarily opened, allows air ingress and direct visualization of the clot through the window. To allow for remote physician inspection, a CCD or CMOS sensor can be attached, with the upstream surface of the clot filter within the sensor's field of view. This allows the contents of the filter to be viewed on a remote monitor. The air intake to clear the optical path from the window to the filter can be remotely controlled using an electronically actuated valve.

[0280] An air bubble filter 2804 can be provided in the line between the needle injection port 2806 and the catheter 2826. The system 2800 further includes a line branch point 2808 (e.g., a Y) in fluid communication with the first source 2810 a and the second source 2810 b. The line branch point 2808 can include a luer lock connector or a Y connector that interfaces with multiple fluid sources.

[0281] The system 2800 can also include a pump (eg, a peristaltic pump 2834 or a rotary piston pump, etc.) that drives fluid under pressure from the second source 2810b to the line branch point 2808 in the direction of arrow 2822c.

[0282] The air bubble sensors can be provided upstream or downstream of the pump 2834. The air bubble sensors 2836a, 2836b can be non-contact ultrasonic sensors that measure the intensity and Doppler shift of reflected ultrasound waves through the sidewall of the fluid tubing to detect bubbles and measure fluid flow rate or level, as discussed above. In some embodiments, the sensor 2836a can be a pressure sensor, or a separate pressure sensor can be provided.

[0283] A valve 2816c (e.g., a ball valve or rotary valve, etc.) can selectively open or close fluid communication between the second source 2810b and the catheter 2826. A flow detector, such as a drip rate sensor 2838, allows for the determination and indication of the flow rate from the second source 2810b.

[0284] Fluid flow from first source 2810a is directed through one-way check valve 2814 onto high-pressure pump 2852, which can be a syringe pump, a high-pressure positive displacement pump, a contrast injection pump, etc. High-pressure fluid (e.g., contrast solution) is directed through air bubble sensor 2836a and through valve 2816b onto branch point 2808. Arrow 2822b indicates the direction of fluid flow.

[0285] Resistance to fluid flow through different catheters in a concentric catheter stack varies based on the available lumen cross-sectional area. For example, the measured resistance through an inner catheter with a completely open lumen (e.g., with the guidewire removed) can be lower than the measured resistance through an outer catheter with a second catheter (or guidewire) extending therethrough. Thus, when performing the saline flushing step, the fluidics system 2800 can be configured to ensure similar flow rates or treatment-appropriate flow rates through each inner and outer catheter to avoid clot formation or other problems in the catheters. To do so, valves can be adjusted for each catheter to ensure that flow rates remain constant among all catheters during saline flushing. The system 2800 can determine such flow rates in real time based on flow sensors, and the control system can be configured to automatically adjust valve settings and / or pump parameters to maintain the desired flow rates through each catheter.

[0286] In some embodiments, fluid resistance can be changed by adjusting the insertion length of each shaft into its concentrically adjacent lumen. As described herein, when there is a reduction in the lumen cross-sectional area for flow, for example, when a second catheter (or guidewire) extends into the lumen, the fluid resistance in the lumen can be greater. The amount of fluid resistance can be affected by the length of the cross-sectional constriction, for example, due to the placement of the second catheter (or guidewire) in the lumen. A second catheter (or guidewire) extending partially through the lumen of a first catheter will provide a smaller length of cross-sectional constriction and therefore may result in lower fluid resistance in the lumen of the first catheter than if the second catheter (or guidewire) had extended completely through the lumen of the first catheter. Therefore, fluid resistance can be reduced by partially retracting the insertion depth of the second catheter (or guidewire) into the lumen through which fluid will be injected.

[0287] System 2800 further includes a suction canister 2840 coupled upstream of filter 2844. The downstream side of filter 2844 is coupled to a vacuum pump 2842. Suction canister 2840 is connected to valve 2816a, which can be in communication with sterile field clot capture container 2802 discussed elsewhere herein. Arrow 2822a indicates the direction of fluid flow.

[0288] An optional pressure sensor 2846 is depicted at the proximal end of the catheter 2826 or hub, which is coupled to a hemostatic valve (eg, a rotary hemostatic valve (RHV) 2848, etc.).

[0289] In this example, the RHV 2848 is connected to two different fluid sources. The RHV 2848 can be carried by and at least partially disposed within a hub (e.g., hub 2724a in FIG. 27). The RHV 2848 can include a first fluid source connection, a second fluid source connection, and a sink connection. For example, the first connection, the second connection, and the third connection can include respective valves (e.g., valves 2816a, 2816b, and 2816c) connected to the RHV 2848 via fluid lines. In some embodiments, the connection points can be formed as part of the RHV 2848 itself, and the fluid lines can connect directly to the connection points at the proximal ends of the fluid lines and connect to the sources and / or sinks at the respective distal ends of the fluid lines. In certain embodiments, the valves 2816a, 2816b, and 2816c can be disposed within a valve manifold or valve manifold cassette. In certain embodiments, pump 2834 can also be disposed in a valve manifold or valve manifold cassette. In certain embodiments, any of valves 2816a, 2816b, and 2816c can be ball valves, stopcock valves, rotary valves, solenoid valves, or any other suitable valves. Any of valves 2816a, 2816b, and 2816c can be controlled by one or more actuators 2817.

[0290] The RHV2848 can be configured to allow a catheter or other instrument to be introduced into a living being's body while preventing unintended backbleeding. In some embodiments, each RHV described herein can be configured with at least a fully closed configuration, a low sealing force state through which a device can be advanced without leakage, and a high sealing force state (e.g., mode) that can prevent fluid escape under high pressure and prevent axial movement of the device therethrough.

[0291] The RHV 2848 is configured to be simultaneously fluidly connected to a first fluid source (e.g., source 2810a) via a first fluid source connection (e.g., valve 2816b). The RHV 2848 is further configured to be simultaneously fluidly connected to a second fluid source (e.g., source 2810b) via a second fluid source connection (e.g., valve 2816c). Additionally, the RHV 2848 is further configured to be simultaneously fluidly connected to a sink (e.g., suction canister 2840) via a sink connection (e.g., valve 2816a).

[0292] In operation, system 2800 is configured to automatically switch between introducing fluid from a first fluid source (e.g., source 2810a) or a second fluid source (e.g., source 2810b) through RHV 2848 into the lumen of the elongate body (e.g., catheter 2826), or allowing fluid removed from the lumen to collect in a sink (e.g., suction canister / sink 2840).

[0293] In some embodiments, the optional pressure sensor 2846 is positioned either upstream or downstream of the RHV 2848 (as shown in FIG. 28). In some embodiments, the optional pressure sensor 2846 is positioned within the catheter (e.g., within the sidewall of the catheter) to measure the arterial pressure at the distal end of the catheter, which pressure can be assessed by the interventionalist to verify that the catheter is not misaligned within the vessel and / or thrombus.

[0294] For example, if the catheter is misaligned with the vessel wall, the detected pressure (e.g., waveform) may be blunted. Such detection may be provided to an algorithm implemented by a processor associated with system 2800 to determine, for example, the patency of the catheter lumen or the patency of the catheter distal tip. Such pressure sensors and algorithms may provide an improved alternative to traditional pressure determinations, which involve manual operation of a fluidics system, where the interventionalist retracts (e.g., pulls back) a syringe connected to the catheter, verifies that blood capture occurs, and assesses tactile feedback from the catheter.

[0295] Such assessment of blood capture and tactile feedback can indicate the patency of the lumen or distal tip before injection or aspiration is performed. However, the pressure sensor 2846 can provide an automated and improved way to assess the patency of the lumen or distal tip. That is, the addition of a pressure sensor 2846 (e.g., a blood pressure sensor) to the proximal end of the catheter can capture the arterial pressure waveform. The waveform can be used to determine, without direct visual or tactile feedback, whether the catheter distal tip is pressing against the vessel wall, whether the catheter tip is pressing against a thrombus, whether the catheter tip is fully patent, or whether the catheter lumen is clogged or fully patent. In some embodiments, the waveform can be used to determine the state of engagement of the catheter distal tip with the clot and / or the consistency of the clot.

[0296] In some embodiments, the fluidics systems described herein (e.g., system 2700, system 2800) include a hemostatic valve (e.g., RHV2848) including a first three-way connector having a first fluid source connection (e.g., one-way valve 2716a, 2816b), a second fluid source connection (e.g., one-way valve 2716b, 2816c), and a sink connection (e.g., one-way valve 2816a).

[0297] In some embodiments, the fluidics systems described herein (e.g., system 2700, system 2800) utilize a first fluid source that includes one of saline, heparinized saline, or a pharmaceutical agent. In some embodiments, the second fluid source (e.g., source 2710b, 2810b) includes a contrast agent.

[0298] Systems 2700, 2800 may further include a second hemostatic valve, which may be in communication with and at least partially disposed within a second hub (e.g., 2724b). The second hemostatic valve may include a third fluid source connection (e.g., valve 2716b), a fourth fluid source connection (valve 2716b), and a second sink connection (e.g., valve 2716c). In this example, first manifold 2718a may include a second output line configured to be connected to the third fluid source connection (not shown).

[0299] FIG. 29 illustrates another embodiment of a fluidics system 3100 for use with a fluidics management system. Generally, the fluidics system 3100 includes a cassette capable of connecting multiple fluid sources and / or sinks to multiple interventional devices. Multiple fluid lines can extend between the sources or sinks and the cassette for connection to different interventional devices. For other sources and sinks, a single fluid line can extend between the source or sink and the cassette and split within the cassette to connect to different interventional devices. In certain embodiments, the cassette can include a connection array (e.g., in rows or columns) formed from connections from multiple fluid sources and / or sinks for connection to a single interventional device. Each connection array can be connected to a tubing set having tubing corresponding to each connection in the connection array.

[0300] The cassette 3141 can be a self-contained unit including a housing with multiple valves, tubing, and connectors, as described below. A first connector array includes multiple releasable connectors (e.g., Luer connectors, etc.) for placing the cassette in fluid communication with complementary connectors, which are in fluid communication with a source of suction and at least one or more fluids. A second connector array is configured for releasable connection to a tubing set configured to extend between the cassette and at least one, two, or three interventional devices.

[0301] Thus, the cassette 3141 forms a bridge module that, when assembled, resides between the various fluid and vacuum sources and the corresponding interventional devices. The cassette 3141 can be configured for single use or can be resterilizable and reusable.

[0302] 29, system 3100 can include a first fluid source 3110a and a second fluid source 3110b. Fluid flow from first source 3110a is directed through a one-way check valve 3114 onto a high-pressure pump 3152, which can be a syringe pump, a high-pressure positive displacement pump, a contrast injection pump, etc. The fluid from first fluid source 3110a can be a contrast solution that is preferably injected under high pressure.

[0303] Fluid flow from the syringe pump is directed into cassette 3141, which may include multiple valves, manifolds, and / or connectors. Within cassette 3141, the fluid flow may split along multiple branches 3118b to multiple connectors 3117b (e.g., four connectors 3117b as shown in FIG. 29) for coupling with different interventional devices. The cassette may include valves 3116b (e.g., ball valves) with each branch 3118b upstream of connector 3117b. In certain embodiments, either valve 3116a or 3116b may be a ball valve, a stopcock valve, a rotary valve, a solenoid valve, or any other suitable valve.

[0304] Fluid flow from the second fluid source 3110b can be directed into multiple branches 3118c to multiple pumps 3134 (e.g., four pumps 3134 as shown in FIG. 29) (e.g., peristaltic pumps, rotary piston pumps, etc.). Each pump 3134 can drive fluid (e.g., saline) under pressure from the second source 3110b to a unique connector 3117c for each interventional device in the cassette 3141.

[0305] The system further includes an aspiration canister 3140 in communication with the upstream side of the filter 3144. The downstream side of the filter 3144 is in communication with a vacuum pump 3142. The aspiration canister receives fluid from a cassette 3141, which includes multiple connectors 3117a, each configured to connect to a unique interventional device. A unique valve 3116a (at least two, and in the illustrated example, four) can be positioned upstream of each connector 3117a. Each unique valve 3116a can be positioned along a branch 3118a.

[0306] In certain embodiments, one or more connector arrays 3146 can be arranged, each configured to couple to an interventional device. For example, connector array 3146 is shown by dashed lines in FIG. 29. As shown in FIG. 29, connector array 3146 can include connector 3117a, connector 3117b, and connector 3117c. As shown in FIG. 29, array 3146 can be organized with all connectors facing the same direction on a common plane (e.g., in a linear row, etc.).

[0307] The connector array 3146 can be releasably coupled to a tubing set 3143 including a suction tube 3154, a first fluid tube 3155, and a second fluid tube 3156. In some embodiments, the connectors 3117a, 3117b, and 3117c can be luer lock connectors. The suction tube 3154 can be coupled to a connector 3117b of the array 3146 via a complementary connector 3117d for suction from the interventional device to the suction container. The first fluid tube 3155 can be coupled to a connector 3117b of the array 3146 via a complementary connector 3117e to provide fluid flow from the first fluid source 3110a to the interventional device. The second fluid tube 3156 can be coupled to a connector 3117c of the array 3146 via a complementary connector 3117f to provide fluid flow from the second fluid source 3110b to the interventional device. The tubes 3154, 3155, and 3156 can be joined together over most of their lengths. The tubes 3154, 3155, and 3156 can each have a length of at least about 3 or 4 feet, and in certain embodiments, a length between about 6 feet and about 8 feet.

[0308] 29 , the tubing set 3143 includes a line branch point 3108 (e.g., a two-to-one wye or a three-to-one wye) that can provide fluid communication between an interventional device and tubing 3154, tubing 3155, and tubing 3156. The line branch point 3108 can include a luer lock connector or a wye connector that interfaces with a complementary connector on the tubing set. In certain embodiments, a one-way valve 3145 can be positioned upstream of the branch point 3108 and downstream of the cassette 3141 along the flow path of the second fluid.

[0309] In certain embodiments, system 3100 (or other systems described herein) is capable of directing the flow of a second fluid (e.g., saline) using two different flow modes. In low-flow drip mode, a flow rate of approximately 1-2 drips per second or 3 mL / min to 6 mL / min can be provided, for example, by pump 3134. In some embodiments, a low-flow mode rate of 1 mL / min to 8 mL / min can be provided. Each catheter connected to the system may experience a different flow resistance, as described herein.

[0310] The pumps (e.g., pump 3134) can be operated to provide the same flow rate into each catheter. In certain embodiments, the fluid pressure in the catheters can be at least about 330 mmHg or 6.5 psi. This pressure can be sufficient to overcome arterial pressure while delivering the desired drip rate. In certain embodiments, the pressure in the catheters can be greater than 330 mmHg. In certain embodiments, the delivered fluid volume can be at least about 1 liter over the length of the procedure. In some embodiments, the fluid volume can be up to 2 liters.

[0311] In high-flow flush mode, all of the fluid lines can be flushed to remove air. The flow rate can be between 100 and 1000 mL / min. The fluid pressure can be between 5 and 10 psi. The delivered volume can be between 0.5 and 1 liter per treatment. The volume can depend on the tubing length and diameter. In some embodiments, the high-flush flow rate is at least about 20 times the low-flow drip mode flow rate, and in some cases, between 30 and 150 times.

[0312] In certain embodiments, the first fluid (e.g., contrast agent solution) can be provided at a flow rate between 3 and 8 L / s (e.g., about 4 mL / s), for example, by pump 3152. In certain embodiments, the flow rate can be up to about 8 mL / s. In other embodiments, the flow rate can be up to about 20 mL / s. In certain embodiments, the first fluid can be provided at a pressure of about 400 psi for a flow rate of about 4 mL / s. The amount of pressure required can depend on the flow rate and flow restrictions in the fluid path. The pressure can increase proportionally with the flow rate for higher flow rates. In certain embodiments, the pressure can be up to 1200 psi.

[0313] In certain embodiments, the high-pressure pump (e.g., pump 3152) is capable of providing a delivery volume of between 5 and 15 mL per high-pressure injection. In certain embodiments, the pump is capable of providing 5 to 15 mL per high-pressure injection in increments of approximately 1 mL per puff. In certain embodiments, the second fluid source is capable of providing a total volume of approximately 200 mL per procedure. In certain embodiments, the syringe pump is sized to hold at least approximately 150 mL or 200 mL, providing uninterrupted flow throughout the procedure without the need to add additional contrast solution. In other embodiments, the second fluid source is capable of providing a total volume of between 150 and 250 mL per procedure.

[0314] In certain embodiments, the flow rate can vary depending on the anatomical location of the distal end of the catheter. For example, in the aortic arch, the flow rate can be about 20 mL / s. A total delivery volume of about 25 mL can be infused into the aortic arch. In the common carotid artery, the flow rate can be about 20 mL / s. A total delivery volume of 12 mL can be infused into the common carotid artery. In the subclavian artery, the flow rate can be about 6 mL / s. A total delivery volume of about 15 mL can be infused into the subclavian artery. In the internal carotid artery, the flow rate can be about 6 mL / s. A total delivery volume of about 8 mL can be infused into the internal carotid artery. In the external carotid artery, the flow rate can be about 3 mL / s. A total delivery volume of about 6 mL can be infused into the external carotid artery. In the vertebral artery, the flow rate can be about 6 mL / s. A total delivery volume of about 8 mL can be infused into the vertebral artery.

[0315] In certain embodiments, a motor can be provided to drive a high-pressure pump (such as pump 3152), which can be controlled by a position and velocity control loop using a potentiometer as a measurement to close the loop. In certain embodiments, current control can be applied to provide an approximate pressure limit. In certain embodiments, the second fluid can be a contrast agent solution, such as Omnipaque 300, Omnipaque 350, or Visipaque 320.

[0316] In certain embodiments, the vacuum pump (such as pump 3142) can provide a pressure of approximately -29.5 inHg or up to -29.5 inHg (-999 mbar). In certain embodiments, the tubing used for aspiration can have an inner diameter of 0.11 inches (approximately 2.8 mm). In certain embodiments, the volume of the aspiration container (such as container 3140) can be at least approximately 0.5 L. In certain embodiments, the volume of the aspiration container can include approximately 0.5 L for blood and additional volume for saline flush. In certain embodiments, the aspiration container can have a volume between 0.25 and 0.75 L. In certain embodiments, the vacuum pump can be configured to operate to additionally provide a low pressure / flow setting to assist in the flushing process when it is desirable or likely that the aspiration line will always be filled with saline (except when aspirating clots). In certain embodiments, a separate pump can be provided for the low pressure / flow setting.

[0317] 30 illustrates certain aspects of an example portion of a robotic catheter system including an embodiment of a system 3200 for managing fluidics. As described further below, in some embodiments, system 3200 can include a pump station 3202 and a cassette 3204. Cassette 3204 can include components and fluid communication channels for a saline subsystem 3206, a contrast subsystem 3208, and a vacuum subsystem 3210. For example, cassette 3204 can include tubing sets and connections / ports for connecting to sources of saline, contrast, and vacuum, one or more peristaltic pumps, one or more valves, one or more sensors, one or more contrast pumps, one or more vacuum canisters, one or more clot pods, and fluid communication channels for communicating saline, contrast, and vacuum from the saline, contrast, and vacuum sources to the hub and catheter. Pump station 3202 can include components that interact with subsystems within cassette 3204 when cassette 3204 is coupled to pump station 3202. In one example, pump station 3202 can include one or more valve actuators, one or more peristaltic pump drivers, and one or more contrast pump drivers configured to actuate and drive valves and pumps within the cassette that are part of the saline, contrast, and vacuum subsystems. Pump station 3202 can also include one or more sensors configured to sense fluid flowing through particular fluid communication channels of cassette 3204.

[0318] In some embodiments, the cassette 3204 and the pump station 3202 include corresponding electrical contacts or connections (both referred to as "contacts") that connect when the cassette 3204 is coupled to the pump station 3202, connecting electrical components (e.g., sensors) within the cassette 3204 to the pump station 3202. The electrical contacts can include contacts for providing information from the components within the cassette (or a hub coupled to the cassette) to a controller within the pump station, or to a controller in communication with the pump station configured to operate a fluidics system, or to another system that utilizes such information. The electrical contacts can include contacts for providing electrical power to the components within the cassette. In some embodiments, the electrical contacts can also electrically connect the pump station 3202 to one or more hubs 3224 via the cassette 3204. Thus, the electrical contacts can provide electrical power to components within one or more hubs via the cassette (and via electrical connections between the cassette and the one or more hubs). Certain components of system 3200 can be configured to be disposable, and certain components can be configured to be reusable. For example, one or more hubs 3224 and the catheters, tubing set 3216, and / or cassette 3204 coupled thereto can be configured to be disposable. Valves associated with controlling the provision of fluids and vacuum in system 3200 can be collectively referred to as a "valve assembly" for ease of reference. Valve assemblies can include, but are not limited to, valves in saline subsystem 3206, contrast subsystem 3208, and vacuum subsystem 3210 located in pump station 3202, cassette 3204, and / or one or more hubs 3224.As described in the examples below, system 3200 provides saline, contrast, and vacuum from a saline source, a contrast source, and a vacuum source (respectively) through fluid communication channels to one or more hubs 3224 and catheters coupled to hub 3224. Fluid communication channels can include channels, tubes, ports, line connectors, and other structures for communicating fluids and providing vacuum. Unless otherwise indicated, "channels," "tubes," and "lines" can be used interchangeably herein to refer to fluid communication channels. For example, fluid communication channels can include channels in cassette 3204, one or more tubes that are part of tubing set 3216, and tubes and / or channels positioned in hub 3224; the fluid communication channels can collectively be referred to as a fluid communication system.

[0319] Embodiments of a saline subsystem 3206, a contrast subsystem 3208, and a vacuum subsystem 3210 that may be used to implement a method for controlling a fluid dispensing device are illustrated in Figures 31, 32, and 33, respectively. Figures 34 and 35 illustrate example fluid system components relative to a hub. Figure 36 illustrates an example tubing set 3216 coupled at one end to a cassette 3204 and at the other end to one or more hubs 3224 and a femoral sheath 3226. Figure 37 illustrates certain components of a robotic catheter system that are part of or associated with a fluidics system, that are operable by or provide information to a controller, and that implement a method for controlling a fluid dispensing device by activating such components and based (at least in part) on such information. Fluidic subsystems and components can be controlled to perform fluidic methods on the robotic catheter system, including, for example, priming a saline subsystem, priming a contrast subsystem, injecting contrast, aspirating clots, and backbleeding hemostasis valves. Such processes are controlled at least in part by a controller (e.g., system controller 3730). Valves, pumps, and other actuatable (or movable) components can be driven to specific states or positions by the controller. In some embodiments, the state or position of an actuatable component can be determined by sensing mechanisms on the component, allowing the controller to determine the component's current position before, during, or after a process. In some examples, the sensing mechanisms can include switches, encoders, or the like.In some embodiments, the current state or location of a component can be electronically stored information (e.g., in a table or file), and the controller is configured to determine the location of one or more components by accessing the stored information. In one example, before contrast is injected using a selected catheter in a system having multiple catheters, a valve connecting the selected catheter to the contrast subsystem can be determined to be aligned in an open position to provide contrast to the selected catheter, and one or more valves connecting non-selected catheters to the contrast subsystem can be determined to be aligned in a closed position to disconnect the non-selected catheters from the contrast subsystem. Such a determination can be made using stored information or by using information from a sensing mechanism. The processes described herein are some examples of processes the controller can be configured to implement by controlling a fluidic device, either automatically or semi-automatically, based on one or more user inputs, sensed information, and / or other information.

[0320] As indicated above, an example of a fluidics system 3200 configured to provide saline, contrast, and vacuum to one or more hubs 3224 and provide saline to a femoral sheath 3226 is illustrated in FIG. 30. The one or more hubs 3224 may include a first hub 3224a, a second hub 3224b, and a third hub 3224c (hereinafter collectively referred to as "hubs 3224a-3224c"). As shown in FIG. 30, a catheter is coupled to each of the one or more hubs, and each of hubs 3224a-3224c is configured to provide saline, contrast, and vacuum from the fluidics system 3200 to the lumen of the catheter coupled to the hub (e.g., as shown in FIGS. 34 and 35). For simplicity of disclosure, unless the context dictates otherwise, providing saline, contrast, or vacuum to a hub also refers to providing saline, contrast, or vacuum to a catheter coupled to the hub. The example in FIG. 30 is a multi-channel fluidics system configured to provide independently controllable amounts of saline, contrast, and vacuum to each of one or more hubs 3224a-3224c and femoral sheath 3226 as needed during a medical procedure. Being able to independently control saline, contrast, and vacuum to each hub is advantageous because each catheter has a differently sized lumen due to the catheters having different inner diameters, and the amount of saline, contrast, and / or vacuum needed during their use can differ based on lumen size. Also, each catheter can have a different effective lumen size, which can change at specific times during a procedure based on the lumen containing another catheter or guidewire nested inside it.Also, since during a medical procedure different amounts of saline, contrast, or vacuum may be desired in each catheter based on the application for which a particular catheter is being used, it may be advantageous to be able to separately control the saline, contrast, and vacuum to each hub. In other embodiments, such a fluidics system may be configured as a one-channel fluidics system that provides controlled amounts of saline, contrast, and vacuum to one hub, or as a multi-channel fluidics system configured to provide controlled amounts of saline, contrast, and vacuum to two hubs or four or more hubs.

[0321] In various embodiments, the fluidics system 3200 illustrated in FIG. 30 can have similar or identical features to other fluidics systems described herein. In this example, the fluidics system 3200 includes a pump station 3202 and a cassette 3204 releasably coupleable to the pump station. The pump station 3202 can include components that may be capital equipment. The cassette 3204 can include components that may be designed for single use, where the cassette is disposable. In an example use, the cassette 3204 is a sterilized, disposable component that is coupled to the pump station 3202 before performing a procedure, and the cassette 3204 is removed and discarded after the procedure is completed. The fluidics system 3200 can include multiple valves, collectively referred to as a valve assembly, that control saline, contrast, or vacuum, located in the cassette, pump station, or hub (e.g., as illustrated in FIGS. 30-35, 37). In various embodiments, portions of the valve assembly can be located in the pump station 3202 or in the cassette 3204. Various embodiments of the valve assembly can include additional, fewer, or different valves than those shown in the figures. The fluid system 3200 can also include sensors in the saline, contrast, and vacuum subsystems, which can collectively be referred to as a sensor assembly. In various embodiments, portions of the sensor assembly can be located in the pump station 3202 or in the cassette 3204. Various embodiments of the sensor assembly can include additional, fewer, or different sensors than those shown in the figures.

[0322] In this example, fluidics system 3200 includes a saline subsystem 3206, a contrast subsystem 3208, and a vacuum subsystem 3210. In some embodiments, vacuum subsystem 3210 can be a vacuum / aspiration (“V / A” or simply “vacuum”) subsystem. An example of saline subsystem 3206 is illustrated in FIG. 31. An example embodiment of contrast subsystem 3208 is illustrated in FIG. 32. An example embodiment of vacuum subsystem 3210 is illustrated in FIG. 33. The embodiments illustrated in FIGS. 31, 32, and 33 can have additional components (e.g., valves, fluid channels / tubing, connectors, etc.) that are not shown for clarity of illustration (e.g., check valves). In various embodiments, certain components of fluidics system 3200 can be part of pump station 3202, and other components can be part of cassette 3204. For example, a portion of the saline subsystem 3206 can be in cassette 3204, and a portion of the saline subsystem can be in pump station 3202. As a specific example, a portion of a peristaltic saline pump that controls the saline flow can be in cassette 3204, and a drive mechanism (e.g., actuator / drive motor, drive member) for the peristaltic saline pump can be in pump station 3202. When the cassette is coupled to pump station 3202, the drive mechanism is coupled to the portion of the peristaltic pump in the cassette, such that controlling the drive mechanism controls the flow of saline through the peristaltic pump. In another example, cassette 3204 can include a saline port for receiving saline from a saline bag positioned outside the cassette, and a weight sensor that senses the weight of the saline bag can be part of the pump station.

[0323] Also, contrast agent subsystem 3208 (or a portion thereof) can be within cassette 3204. For example, a contrast agent syringe pump (or a portion thereof) can be positioned within cassette 3204, and cassette 3204 can include a contrast agent port for receiving contrast agent from a contrast agent container positioned outside cassette 3204. Pump station 3202 can include an air column detector configured to detect air in a fluid communication channel (e.g., tubing) between the contrast agent container and the syringe pump.

[0324] Further, the vacuum subsystem 3210 (or a portion thereof) can be included in the cassette 3204, and a portion of the vacuum subsystem can be included in the pump station. For example, the vacuum canister and vacuum control valve can be in the cassette 3204, and the vacuum pump and actuator for the vacuum control valve can be located in the pump station 3202. As another example, the cassette 3204 can include a vacuum port for connecting to a vacuum source of the pump station. Other configurations are also possible, in which certain components of the saline subsystem 3206, the contrast subsystem 3208, and the vacuum subsystem 3210 are located in the pump station 3202, and other components of the saline subsystem 3206, the contrast subsystem 3208, and the vacuum subsystem 3210 are located in the cassette 3204.

[0325] The saline, contrast, and vacuum ports are part of a fluid communication system that includes fluid communication channels (e.g., channels, tubing, lines, etc.) for connecting the catheter to a saline supply, a contrast supply, and a vacuum supply. Cassette 3204 includes a portion of the fluid communication system that is connectable to the saline, contrast, and vacuum sources, and valves within the cassette partially control fluid flow through the channels of the fluid communication system within the cassette. The fluid communication system also includes a tubing set 3216. Tubing set 3216 can include fluid communication channels for communicating saline, contrast, and / or vacuum to hubs 3224a-3224c and / or for communicating saline to femoral sheath 3226. In this example, tubing set 3216 includes saline tubing 3218, contrast tubing 3219, and vacuum tubing 3220. In a preferred embodiment, the tubing set includes flexible tubing for providing saline, contrast, and vacuum to the hub. For example, according to some embodiments, the tubing may be 4' to 10' in length. As illustrated in the embodiment of FIG. 30, the saline subsystem 3206 includes a first connector array 3212a, a second connector array 3212b, and a third connector array 3212c, which represent locations where saline, contrast, or vacuum is provided. Depending on the configuration of the cassette 3204, in some embodiments, the first connector array 3212a, the second connector array 3212b, and the third connector array 3212c can be disposed within the second connector array 3214 to which the tubing set 3216 can be coupled. Electrical channel 3217 can connect first hub 3224a, second hub 3224b, and third hub 3224c to cassette 3204 or to pump station 3202 and can be used to provide control signals to the hubs or receive information from the hubs.The illustrated electrical channel 3217 is a physical communication channel (e.g., including a wire, cable, or optical fiber), however, in some embodiments where the electrical channel 3217 is configured to provide control signals to or information from the hubs 3224a-3224c, the electrical channel 3217 may be a wireless communication channel.

[0326] Each of the hubs 3224a-3224c (also referred to herein as "hub assemblies") can include multiple components associated with providing saline, contrast, and vacuum to the catheter, as well as components associated with axially moving the hub and an interventional device attached to the hub and rotating the catheter. The tubing set 3216 can also include electrical connections for communicating control information to one or more hubs 3224 and / or receiving information (e.g., sensor information) from the components of the hubs 3224a-3224c. A proximal end 3234 of the tubing set 3216 can be coupled to the cassette 3204, and a distal end 3232 of the tubing set 3216 can be coupled to the hubs 3224a-3224c and the femoral sheath 3226. In the illustrated example, each of the hubs 3224a-3224c is coupled to the cassette 3204 by an electrical channel 3217, saline tubing 3218, contrast tubing 3219, and vacuum tubing 3220. Example fluidic components of a hub embodiment are illustrated in FIG. 34. In some embodiments, the hubs 3224a-3224c can include additional components. For example, the hubs can include components associated with coupling an interventional device to the hub, axially moving the hub and interventional device, and rotating the interventional device. An example tubing set 3216 is further illustrated in FIG. 36.

[0327] FIG. 31 illustrates certain components and connections of an example saline subsystem 3206, which can be the saline subsystem 3206 illustrated in FIG. 30. In this embodiment, the saline subsystem 3206 includes a saline weight sensor 3250 coupled to a saline bag 3251. A contrast spike 3252 is used to puncture the saline bag 3251 and allow saline to flow through a saline tube 3253 and into a saline chamber 3254. An air vent 3255 above the chamber allows air to escape from the saline chamber 3254 as it fills with saline. A chamber level detector 3256 is positioned to sense the saline level in the chamber. A line 3257 communicates saline from the saline chamber 3254 to a saline manifold 3258. Four peristaltic pumps 3262a, 3262b, 3262c, and 3262d (hereinafter "peristaltic pumps 3262a-3262d") receive saline from saline manifold 3258 via lines 3260a, 3260b, 3260c, and 3260d (hereinafter "lines 3260a-3260d"). Each of peristaltic pumps 3262a-3262d is driven by an actuator 3263a, 3263b, 3263c, and 3263d (hereinafter "actuators 3263a-3263d"). In some embodiments, including the example in FIG. 31, the peristaltic pumps are positioned in cassette 3204, and actuators 3263a-3263d are positioned in pump station 3202. When peristaltic pumps 3262a-3262d are driven by actuators 3263a-3263d, saline flows through lines 3264a, 3264b, 3264c, 3264d (hereinafter "lines 3264a-3264d") to ports S1-S4, respectively, which can be in a connector array connectable to tubing set 3216.

[0328] In the illustrated embodiment, saline / contrast valve 3266 is included in line 3264c. Saline / contrast valve 3266 can be moved to a first position or a second position by saline / contrast valve actuator 3267, which can be in pump station 3202. Saline / contrast valve 3266 is configured such that when it is in the first position (shown in FIG. 31 ), saline / contrast valve 3266 connects line 3264c to line 3270 and routes saline from peristaltic pump 3262c to contrast manifold 3318 ( FIG. 32 ) for priming contrast subsystem 3208. When saline / contrast valve 3266 is in the second position, saline / contrast valve 3266 connects line 3264c to line 3268 and to port S3.

[0329] 32 illustrates certain components and connections of an embodiment of the contrast agent subsystem 3208. In this embodiment, the contrast agent subsystem 3208 includes a contrast agent container 3302, a connection 3304 to the contrast agent container (e.g., a "contrast agent spike"), and a line 3305 coupled to the connection 3304 and to a contrast agent intake valve 3307. The contrast agent intake valve 3307 is opened and closed by a contrast agent intake valve actuator 3308. A line 3309 is coupled to the contrast agent intake valve 3307 and to a contrast agent pump 3310, such that the line 3309, the contrast agent intake valve 3307, the line 3305, and the connection 3304 form a fluid communication channel between the contrast agent pump 3310 and the contrast agent container 3302, where the contrast agent intake valve 3307 is configured to open or close the fluid communication channel. An air column detector 3306 is positioned to detect air in the line 3305 and generate corresponding information (e.g., a signal), which the system controller 3800 can use as input to implement a process.

[0330] The contrast pump 3310 includes a housing 3311 that encloses a contrast chamber 3313 that receives contrast from the contrast container 3302. The contrast pump 3310 includes a wall or movable portion 3312 that can be moved to increase or decrease the size of the contrast chamber 3313. The movable portion 3312 is coupled to a movable member 3314 that can be moved by a linear contrast pump actuator 3315 that includes a motor. In some embodiments, the contrast intake valve actuator 3308, the contrast pump actuator 3315, and the air column detector 3306 (run-out sensor) can be positioned in the pump station 3202, and the contrast intake valve 3307 (between the connection 3304 and the contrast pump 3310), the contrast pump 3310, the contrast control valves 3322a, 3322b, 3322c (hereinafter "contrast control valves 3322a-3322c"), and the lines and components that connect the contrast to ports C1, C2, C3 can be positioned in the cassette 3204, as shown in FIG. 30.

[0331] Contrast is provided by line 3316 from contrast pump 3310 to contrast manifold 3318. Contrast manifold 3318 provides fluid communication channels to contrast ports C1, C2, and C3 via lines 3320a, 3320b, 3320c (hereinafter "lines 3320a-3320c"), contrast control valves 3322a-3322c, and lines 3326a, 3326b, 3326c (hereinafter "lines 3326a-3326c"). Contrast valve actuators 3324a, 3324b, 3324c (hereinafter "actuators 3324a-3324c") are coupled to contrast control valves 3322a-3322c when cassette 3204 is coupled to pump station 3202 and are controlled by system controller 3800 to open and close contrast control valves 3322a-3322c to perform a preparation process (e.g., priming) or to perform a medical procedure (e.g., injecting contrast). Line 3270 is a fluid communication channel connected to the saline subsystem 3206 connection and allows saline to flow from saline subsystem 3206 to contrast manifold 3318 as controlled by saline / contrast valve 3266.

[0332] FIG. 33 illustrates an example embodiment of a vacuum subsystem 3210 that includes a vacuum source (vacuum pump 3388), a communication channel that can be aligned to provide vacuum from the vacuum source to the catheter, and components for controlling the provision of vacuum to the catheter. Various configurations of the vacuum subsystem are possible to selectively provide vacuum to portions of the fluid system and catheter at various amounts of vacuum, e.g., at a first level (e.g., a lower level) and a second level (e.g., a higher level). In the embodiment illustrated in FIG. 33, vacuum pump 3388 is coupled to lines 3385, 3389, and 3383 that provide channels to a vacuum canister 3382. Specifically, in this example, vacuum pump 3388 is coupled to line 3385, which is coupled to vacuum regulator 3390, which can be controlled by a controller to provide a desired level of vacuum. Line 3389 is coupled to vacuum regulator 3390 and is also coupled to sterile filter 3386. Line 3383 is connected to a sterile filter and vacuum canister 3382, which provides a reservoir for collecting aspirated material 3399. Line 3373 is also connected to vacuum canister 3382 and to a vacuum manifold 3375, which is further connected to channels that provide vacuum to multiple hubs / catheters of a robotic catheter system, for example, as shown in FIGS. 34 and 35. In this example, line 3373 is connected to a vacuum regulator valve 3377, which can be controlled by a controller to provide a desired level of vacuum to downstream vacuum subsystems (e.g., vacuum manifold 3375, ports V1-V3, etc.). Vacuum pressure sensor 3371 can be positioned between vacuum regulator valve 3377 and ports V1-V3 to measure the vacuum provided to the hubs and catheters.In this example, vacuum pressure sensor 3371 is positioned on line 3373 between vacuum regulator valve 3377 and clot pod 3427b, which is positioned on line 3373 between vacuum manifold 3375 and vacuum regulator valve 3377 to receive clots aspirated by any one of multiple catheters connected to vacuum subsystem 3210. In some embodiments, clot pod 3427 includes clot pod sensor 3432, which is in communication with the controller to provide information of the contents of clot pod 3427 (e.g., when clot pod 3427 contains a clot). Flow sensor 3380 (e.g., an ultrasonic flow sensor) is positioned between clot pod 3427 and vacuum manifold 3375 to sense the flow of material through line 3373 and provide the flow information to the controller.

[0333] Vacuum manifold 3375 can be connected to lines 3379a, 3379b, 3379c (hereinafter "lines 3379a-3379c") and lines 3378a, 3378b, 3378c (hereinafter "lines 3378a-3378c"), which provide vacuum channels to the hub / catheter via ports V1-V3. Vacuum control valves 3374a, 3374b, 3374c (hereinafter "vacuum control valves 3374a-3374c") may be one-way valves and are connected between lines 3379a-3379c and lines 3378a-3378c to control the provision of vacuum to ports V1-V3, and vacuum control valves 3374a-3374c are opened and closed by vacuum control valve actuators 3376a, 3376b, 3376c) (hereinafter "vacuum control valve actuators 3376a-3376c") of pump station 3202, and vacuum control valve actuators 3376a-3376c are controlled by a controller. To provide vacuum to one or more of ports V1-V3 and the hubs and catheters coupled to ports V1-V3, the controller opens vacuum control valves 3374a-3374c corresponding to the desired port, activates vacuum pump 3388, controls vacuum regulator 3390 and vacuum regulator valve 3377 to create the desired vacuum, and monitors the vacuum being provided using vacuum pressure sensor 3371. Some embodiments may include a flow sensor 3380 associated with each port V1-V3 and / or a vacuum pressure sensor 3371 associated with each port V1-V3. However, in most procedures, vacuum is provided to one catheter at a time, and in such cases, multiple flow and pressure sensors do not provide an operational advantage, and positioning a single flow sensor 3380 and a single vacuum pressure sensor 3371 upstream of vacuum manifold 3375, as shown in FIG. 33, reduces costs.In some embodiments, vacuum pump 3388, vacuum regulator 3390, vacuum control valve actuators 3376a-3376c, and flow sensor 3380 are part of pump station 3202, and sterile filter 3386, vacuum canister 3382, vacuum regulator valve 3377, vacuum pressure sensor 3371, clot pod 3427, and vacuum control valves 3374a-3374c are positioned in cassette 3204.

[0334] FIG. 34 illustrates an example of a catheter 3430 coupled to an embodiment of a tubing set 3216 in a hub portion 3410 of a fluidics management system. A distal end 3232 of the tubing set 3216 is coupled to the hub 3224 and the catheter 3430, and a proximal end 3234 of the tubing set 3216 can be connected to a cassette 3204, which can include all or a portion of the saline subsystem, all or a portion of the contrast subsystem, and / or all or a portion of the vacuum subsystem of the fluidics management system. Certain components illustrated in FIG. 34 can be described as being part of the tubing set 3216, even though they could be within the hub 3224 or within a portion of the sterile adapter, because they operate to perform some of the fluid and vacuum communication functionality facilitated by the configuration of the tubing set. The means for providing fluid and electrical connections to the catheter may include one or more of the saline subsystem, contrast subsystem, vacuum subsystem, and / or electrical connections described herein.

[0335] 34, catheter 3430 can be coupled to a portion of a tubing set 3216 of the fluidics management system via a luer connection 3426. In this example, the portion of tubing set 3216 includes contrast tubing 3437 connected to port / connection point C1, saline tubing 3439 connected to port / connection point S1, and suction tubing 3435 connected to port / connection point V1. One or more electrical channels 3217 are connected to port / connection point E1, which can be on cassette 3204 or pump station 3202. In some embodiments, electrical channel 3217 is part of tubing set 3216, which includes tubing for communicating saline, contrast, and vacuum tubing from the cassette to a hub and electrical connections to the hub; such an embodiment can be advantageous for wire / tubing management. The tubing set 3216 can include a branch point in the form of a two-to-one Y-connector 3420, which connects the upstream contrast tubing 3437 and the upstream saline tubing 3439 of the tubing set 3216 to a single downstream saline / contrast tubing 3440. The tubing set can further include a three-way valve 3423 that can be actuated by a three-way valve actuator 3424 to selectively place the catheter 3430 in communication with either the single downstream saline / contrast tubing 3440 or the suction tubing 3435. In some embodiments, the tubing set 3216 can further include a catheter connection tube 3433 downstream of the three-way valve 3423 for connecting the three-way valve 3423 with the catheter 3430. The three-way valve actuator 3424 can be actuated by a controller. In some embodiments, the three-way valve actuator 3424 includes a drive assembly configured to move the three-way valve 3423 .In some embodiments, the three-way valve actuator 3424 includes an electromechanical means for moving the three-way valve 3423, the electromechanical means being controlled by a controller, hi some embodiments, the three-way valve actuator 3424 includes a motor controlled by a controller.

[0336] In some embodiments, the three-way valve 3423 can be a three-way stopcock. The three-way valve 3423 can be actuated (e.g., rotated) to selectively provide or prevent fluid communication between ports coupled to the saline / contrast tubing 3440, the suction tubing 3435, and the catheter connecting tubing 3433. The three-way valve 3423 can be actuated to a first position to open the fluid communication channel between the suction tubing 3435 and the catheter connecting tubing 3433, and to a second position to open the fluid communication channel between the saline / contrast tubing 3440 and the catheter connecting tubing 3433. In some embodiments, the three-way valve 3423 can be actuated to a third position in which the suction tubing 3435, the saline / contrast tubing 3440, and the catheter connecting tubing 3433 are all in fluid communication. In some embodiments, the three-way valve can be actuated to a fourth position in which the vacuum tubing 3435 and the saline / contrast tubing 3440 are in fluid communication. In some embodiments, the three-way valve 3423 can be actuated to a fifth position in which none of the suction tube 3435, the saline / contrast tube 3440, and the catheter connection tube 3433 are in fluid communication.

[0337] Although a three-way valve 3423 is shown in FIG. 34, other valve arrangements can be used to selectively place the catheter 3430 in communication with the saline / contrast tube 3440 or the suction tube 3435.

[0338] 34, an air bubble filter 3422 can be positioned between the Y-connector 3420 and the three-way valve 3423. In some embodiments, a clot pod 3427 can be positioned along the suction tube 3435 upstream of the three-way valve 3423. A clot pod sensor 3432 (in communication with the controller) can be positioned to detect material on the clot pod 3427. In some embodiments, the clot pod 3427 can be positioned within the hub 3224 along the suction tube 3435 upstream of the three-way valve 3423. In some implementations, the Y-connector 3420, the three-way valve 3423, the three-way valve actuator 3424, the clot pod 3427a, and / or portions of the tubing set can be housed within a magnetic sterile adapter, which can couple with the hub 3224 (which can also be referred to as a puck) and can be considered part of the hub assembly. In some embodiments, clot pod 3427b can be positioned. Clot pod 3427a can be positioned along suction tube 3435 closer to vacuum canister 3382, for example, between vacuum manifold 3375 and vacuum canister 3382, as shown in the embodiment in FIG.

[0339] A hemodynamic pressure sensor 3429 can be positioned between the three-way valve 3423 and the catheter 3430, for example, on the catheter connection tube 3433. The hemodynamic pressure sensor 3429 is configured to sense the hemodynamic pressure of a patient into which the catheter 3430 is inserted and provide information regarding the sensed pressure to the controller. FIG. 35 illustrates another embodiment of components and fluid communication channels that can be coupled to and / or positioned within the hub, and also illustrates an example of another interventional device 3431 (e.g., catheter, guidewire) that can be coupled to the other hub and positioned to extend at least partially through the hemostatic valve 3428 into the lumen of the catheter 3430.

[0340] 36 illustrates an example embodiment of a tubing set 3216 that can provide a communication channel from the cassette to one or more hubs and the femoral sheath. The tubing set 3216 has a distal end 3232 and a proximal end 3234. In this example, different portions of the distal end 3232 are coupled to a first hub 3224a, a second hub 3224b, a third hub 3224c, and the femoral sheath 3226. Different portions of the proximal end 3234 are coupled to a contrast connection, a saline connection, a vacuum connection, and an electrical connection on the cassette. In this example, different portions of proximal end 3234 are coupled to contrast ports (C1, C2, C3) of the contrast subsystem, saline ports (S1, S2, S3, S4) of the saline subsystem, and vacuum ports (V1, V2, V3) of the vacuum subsystem, providing fluid communication channels from the contrast source, saline source, and vacuum source to the hub, and from the saline subsystem to the femoral sheath. In this example, tubing set 3216 also includes electrical communication channels connected to hubs 3224a-3224c and connectors E1, E2, E3 on cassette 3204. The electrical communication channels can provide power to the hub to operate the hub's components and / or provide signals / information from the hub (e.g., from a hemodynamic sensor positioned in or on the hub) to the cassette. The cassette may include electrical connections that couple to corresponding electrical connections on the pump station when the cassette is attached to the pump station, such that the pump station can provide power to the hub via electrical communication channels in the cassette and tubing set and / or receive signals / information from the hub via electrical communication channels in the tubing set and cassette.

[0341] FIG. 37 illustrates a schematic diagram of an example robotic catheter system including a remotely located system ("remote system") and a locally located system (which may be referred to as a "local system," "bedside system," or "near-patient system"). FIG. 37 also illustrates an example of certain components of a local system, including certain components of a fluid management system ("fluidics system"), including actuatable components operated by a controller and sensors that provide information to the controller for the controller to control the fluidics system and other aspects of the robotic catheter system, according to some embodiments. The remote portion includes a control system 3710 that is located remotely from the patient. "Remote," as used herein, is a broad term and generally refers to a location other than where the patient / local system is located when the patient undergoes medical treatment using the robotic catheter system. For example, in a different room from the patient, or in a different building, or in a different town, city, or state. In some embodiments, the remote portion is located hundreds or thousands of miles away from the local portion. The control system 3710 is configured to communicate with a system controller 3800 that is part of the local portion of the system. The system controller 3800 may include multiple controllers, each having one or more processors. In this example, the system controller 3800 includes an interface 3735. The interface 3735 may include multiple interfaces and may be a user interface. The interface 3735 may be configured to communicate with a remotely located control system 3710.For example, interface 3735 can be configured to receive control signals from control system 3710 to perform fluid actions (e.g., inject contrast from a catheter, provide suction from a catheter), or to move one or more of hubs 3224, move one or more catheters or guidewires (axially or rotationally), and communicate corresponding signals to a controller (e.g., controller 3720 or pump station 3740). Interface 3735 can also be configured to receive control information from a locally located user (e.g., for fluid actions or to control movement of a hub coupled to an interventional device, and to provide information (status, images, etc.) to the local user). Interface 3735 can include multiple interfaces, such as one or more displays that display information about the robotic catheter system, the medical procedure, and / or the patient. Interface 3735 can also include one or more user input devices, such as switches, buttons, touchscreen controls, etc.

[0342] Interface 3735 can also be configured to communicate information to a remotely located control system 3710. The communicated information can relate to received control actions, fluid information, catheter position information, status information, images or video, voice and other communications from a robotic system or user located locally with the patient, and any other information that may be needed to control the robotic catheter system from control system 3710. Interface 3735 can also be configured to receive input from a user of the robotic catheter system located with the patient.

[0343] The system controller 3800 may include a pump station 3740 for performing fluid-related actions and a controller 3720 configured to process user input received locally or from the control system 3710, configured to process sensor information, and configured to control the pump station 3740 and other portions of the robotic control system to perform a medical procedure based on the user input and sensed information (including providing saline, contrast, and vacuum to the hubs 3224a-3224c and providing saline to the femoral sheath as needed during the medical procedure).

[0344] 37 can include actuable components of a fluidics management system, which are movable to align with fluid communication channels as controlled by a controller to provide saline, contrast, and vacuum from a saline source, a contrast source, and a vacuum source (respectively) to the hubs 3224a-3224c, including specific sensors configured to sense conditions related to providing saline, contrast, and vacuum to the hubs 3224a-3224c and providing the sensed information to the controller. The controller can be configured to use sensed information, user input, and / or stored information to control actions of the fluidics system to perform a medical procedure. In various embodiments, the pump station 3740 can include a controller for controlling actuators of the pump station 3740 to perform fluid-related actions (e.g., providing saline, contrast, and vacuum to the hubs 3224a-3224c). In other embodiments, controller 3720 and / or system controller 3800 can be configured to control actuators and other components of pump station 3740 to perform fluid-related actions. Many components and systems of the robotic catheter system may not be shown in FIG. 37 for clarity of this illustration (e.g., hub axial drive system, check valves, catheter rotation system, controller of remote control system 3710, etc.).

[0345] A cassette configured to be releasably attached to a pump station can include all or part of saline subsystem 3206, contrast subsystem 3208, and vacuum subsystem 3210. The determination of what is disposable can be based on contact or near contact with patient material (cells, blood, removed clots, etc.). In some embodiments, the cassette and its components are disposable, and pump station 3202 and its components are not disposable (e.g., capital equipment). In the example of saline subsystem 3206, pump station 3202 can include saline weight sensor 3250 and saline drip rate sensor 3259, peristaltic pump actuators 3263a-3263d, and saline / contrast valve actuator 3267, and cassette 3204 can include saline level detector 3245, peristaltic pumps 3262a-3262d, and saline / contrast valve 3266 (FIG. 31). In an example of a contrast subsystem 3208, pump station 3202 can include a contrast intake valve actuator 3308, a contrast pump actuator 3315, contrast valve actuators 3324a-3324c, and an air column detector 3306, and cassette 3204 can include contrast valves 3322a-3322c, a contrast pump 3310, and a contrast intake valve 3307 (FIG. 32). In an example of a vacuum subsystem 3210, pump station 3202 can include a vacuum pump 3388, a vacuum regulator 3390, vacuum control valve actuators 3376a-3376c, and a flow sensor 3280 (e.g., an ultrasonic flow sensor), and cassette 3204 can include a vacuum regulator valve 3377, a vacuum pressure sensor 3371, a clot pod sensor 3432, and vacuum control valves 3374a-3374c. In various embodiments, pump station 3202 and cassette 3204 can include additional or fewer components.Also, in some embodiments, certain components illustrated and / or described herein as being part of a cassette may be positioned within a pump station, and certain components illustrated and described herein as being part of (or supported by) a cassette may be positioned within a pump station.

[0346] In Figure 37, components shown in solid lines represent actuatable components and sensors, where actuatable components can be controlled directly or indirectly by a controller and sensors provide information to the controller. Components shown in dashed lines are neither sensors nor actuatable components (e.g., ports S1-S4, C1-C3, V1-V3; saline chamber, vacuum canister, femoral sheath). In this embodiment, the actuabl...

Claims

1. 1. A system for delivering a fluid to a target site in a patient's vasculature, comprising: a catheter including a tubular catheter shaft having a proximal end, a distal end, and a lumen defined by an interior surface of the catheter shaft extending longitudinally through the catheter shaft between the proximal and distal ends; a guiding element having a distal end, a proximal end, and an exterior surface, positioned within the lumen and configured to create an effective cross-sectional area for fluid communication between the exterior surface of the guiding element and the interior surface of the catheter of about 0.001257 square inches or greater, the system being configured to move the catheter and guiding element such that the guiding element and the distal end of the catheter are advanced toward the target site with the guiding element at least partially within the lumen of the catheter; a contrast pump coupled to the catheter in fluid communication with the lumen, the system being configured to operate the contrast pump with the guiding element at least partially positioned within the lumen of the catheter to provide contrast medium into the proximal end of the catheter at a pump pressure of about 400 psi or less, the provided contrast medium propagating along the exterior surface of the guiding element through the lumen of the catheter and exiting the distal end of the catheter, the effective cross-sectional area permitting a predetermined flow rate of the contrast medium to exit the distal end of the catheter; Including, the system.

2. The system of claim 1 , wherein the predetermined flow rate is at least about 3 cc per second.

3. The system of claim 1 , wherein the effective cross-sectional area is annular in shape or an eccentric annular in shape.

4. The system of claim 1 , wherein the guiding element is a guidewire.

5. 5. The system of claim 4, wherein the guiding element has a diameter of about 0.014 inches or about 0.020 inches, or the guiding element has a diameter between about 0.014 inches and about 0.020 inches.

6. 5. The system of claim 4, wherein the diameter of the lumen of the catheter is about 0.045 inches or about 0.049 inches, or the diameter of the lumen of the catheter is between about 0.045 inches and about 0.049 inches.

7. The system of claim 1 , wherein the distal end of the catheter is thermoformed.

8. The system of claim 1 , wherein the distal end of the catheter comprises a hypotube.

9. The system of claim 8 , wherein the hypotube is laser cut.

10. The system of claim 1 , wherein the catheter includes a braided reinforcement layer of stainless steel wire around the lumen.

11. 2. The system of claim 1, wherein the catheter is a first catheter, and the system further includes a second catheter and a third catheter, the second catheter and the third catheter being positioned such that the guiding element, the first catheter, the second catheter, and the third catheter are concentrically arranged, and such that at least a portion of the guiding element, the first catheter, and the second catheter are inside the third catheter when providing the contrast medium through the lumen of the first catheter.

12. The system of claim 1 , wherein the guiding element includes a hydrophilic coating.

13. The system of claim 1 , wherein the guiding element includes a hydrophilic coating at its distal end and a hydrophobic coating at its proximal end, the hydrophobic coating comprising polytetrafluoroethylene.

14. 1. A method for delivering a fluid to a target site in a patient's vasculature using a robotic catheter system, comprising: moving the distal end of a guiding element toward the target site; moving the distal end of the catheter toward the target site with at least a portion of the guiding element positioned within a lumen of the catheter; providing a contrast medium into the proximal end of the catheter at a pressure of about 400 psi or less with at least a portion of the guiding element positioned within the lumen of the catheter, the provided contrast medium propagating along an outer surface of the guiding element, through the lumen, and exiting the distal end of the catheter, the lumen and the guiding element being sized to create an effective cross-sectional area between the outer surface of the guiding element and an inner surface of the catheter of about 0.001257 square inches or more and sized to provide a predetermined flow rate of the contrast medium out of the distal end of the catheter; A method comprising:

15. 15. The method of claim 14, wherein the predetermined flow rate is at least about 3 cc per second.

16. The method of claim 14 , wherein the effective cross-sectional area is annular in shape or an eccentric annular in shape.

17. 15. The method of claim 14, wherein the guiding element has a diameter of about 0.014 inches or about 0.020 inches, or the guiding element has a diameter between about 0.014 inches and about 0.020 inches, and the diameter of the lumen of the catheter is about 0.045 inches or about 0.049 inches, or the diameter of the lumen of the catheter is between about 0.045 inches and about 0.049 inches.

18. The method of claim 14 , further comprising providing the contrast medium while moving at least one of the guiding element or the catheter toward the target site.

19. 15. The method of claim 14, wherein the catheters are a first catheter, a second catheter, and a third catheter, and the first catheter, the second catheter, and the third catheter are positioned such that the guiding element, the first catheter, the second catheter, and the third catheter are concentrically arranged, and at least a portion of the guiding element, the first catheter, and the second catheter are inside the third catheter when providing the contrast medium through the lumen of the first catheter.

20. 15. The method of claim 14, wherein the guiding element is coupled to a first hub, the catheter is coupled to a second hub, the first hub is magnetically coupled to a first carriage of a drive assembly through a sterile barrier, and the second hub is magnetically coupled to a second carriage of the drive assembly through the sterile barrier, and wherein moving the distal end of the guiding element and the distal end of the catheter comprises moving the first carriage and moving the second carriage.

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