Contrast agent compatible guidewire and catheter stack

Abstract

A system for delivering a fluid to a target site of a patient's vasculature has a catheter having a proximal end, a distal end, and a lumen defined by an inner surface of the catheter, the lumen extending longitudinally through the catheter between the proximal and distal ends, a guide element having a distal end, a proximal end, and an outer surface, the guide element having a distal end, a proximal end, and a distal end. The guide element is located in the lumen, creating a region between the outer surface of the guide element and the inner surface of the catheter, the region having an effective cross-sectional region dimensioned to be in fluid communication when the guide element is in the lumen. Further, a method of performing a neurovascular procedure includes providing a multi-catheter assembly including an access catheter, a guide catheter, and a procedure catheter, connecting the assembly to a robotic drive system, and injecting a contrast agent into the assembly without removing a guide element.

Description

[0001] Incorporation by reference into any priority application

[0002] Any and all applications for which foreign or domestic priority claims are identified in the Application Data Sheet filed with this application are hereby incorporated by reference pursuant to 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 of this specification. Background Art Technical Field

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

[0004] Related technical description

[0005] A variety of neurovascular procedures can be performed via transvascular access, including thrombectomy, diagnostic angiography, embolic coil deployment, and stent placement. However, the delivery of neurovascular care is limited or delayed by multiple challenges. For example, there are insufficient trained interventionalists and medical centers to meet the current demand for neurointerventions. Neurointerventions are difficult and place complex demands on the surgeon's dexterity. The surgeon must use both hands to precisely control three to four coaxial catheters while simultaneously managing the fluoroscopic system and patient positioning. Long, tortuous anatomy requires delicate and accurate manipulation. Inadvertent catheter movement can occur due to the energy storage and release caused by frictional interaction between the coaxial axes and the patient's vasculature. Achieving the necessary supra-aortic access to reach the neurovasculature is challenging, particularly for the type III arch. For example, during current neurothrombectomy procedures, the surgeon must remove the guidewire from the catheter to perform dye injection. Numerous dye injections are required to navigate the complex vasculature directly to the brain, necessitating guidewire removal more than ten times during the procedure. The additional step of removing the guidewire increases the duration of the procedure, increases time costs, and creates a risk of introducing air bubbles into the patient. Even when supra-aortic access is achieved, adapting the system for neurovascular treatment is still time consuming and requires removal of the guidewire and access catheter and addition of the surgical catheter (and possibly one or more additional catheters) to the stack.

[0006] Therefore, there remains a need for a supra-aortic access and neurovascular site access system that addresses some or all of these challenges and increases the availability of neurovascular surgery. Preferably, the system is additionally capable of driving devices more distally through supra-aortic access to complete surgery in intracranial vessels. Summary of the Invention

[0007] According to one aspect of the present invention, a supra-aortic access robotic control system is provided. The supra-aortic robotic control system can deliver fluid to a target site in a patient's vasculature. The system can include a catheter comprising a tubular shaft, a lumen extending longitudinally through the shaft, a proximal end, and a distal end, and a guide element, which is typically a guidewire, but can also be another elongated medical device, including but not limited to a catheter. The guide element and the catheter are sized such that the guide element can be positioned within the lumen of the catheter. When describing aspects of delivering fluid to a target site through the lumen of a catheter while the guide element is positioned within the lumen, for ease of reference, the "guide element" will generally be referred to herein as a "guidewire," and in many applications, the guide element is a guidewire. Therefore, unless otherwise specified in the description, references to a "guidewire" or "guide element" can refer to a guidewire, a catheter, or another elongated medical device. The guidewire can be configured to remain within the lumen of the catheter, creating a space with an annular cross-section, and the guidewire can be navigated by a user to the target site in the patient's vasculature, such that the distal end of the catheter is also advanced to the target site. The guide element can include surfaces having different properties, for example, a hydrophilic coating on its distal end and a hydrophobic coating on its proximal end. In an example, the hydrophobic coating is polytetrafluoroethylene (PTFE), or comprises a PTFE-based composition. The system can also include a pump, syringe, or injector configured to deliver a fluid under pressure through the proximal end of the catheter to obtain a desired flow rate such that the fluid is pushed through the annular lumen and exits the distal end at the target site. In some embodiments, the catheter lumen through which the fluid is communicated can have an inner diameter (ID) of at least about 0.045". For example, the ID can be from 0.045" to about 0.048". The catheter and guidewire are configured to allow sufficient fluid to flow through the lumen even when the guidewire is fully or partially positioned in 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 that is available for communicating fluid. In an example, the effective cross-sectional area of ​​the catheter lumen can be determined by subtracting the cross-sectional area of ​​the guide element in the lumen from the cross-sectional area of ​​the lumen. In some embodiments, the catheter and guidewire are constructed so that In some embodiments, the guide wire can have a diameter of 0.014 inch, 0.018 inch or 0.014 inch to 0.018 inch. In some embodiments, the guide wire can have a diameter of 0.018 inch, 0.020 inch or 0.018 inch to 0.020 inch.In some embodiments, the guidewire can have a diameter of 0.024 inches, or a diameter of 0.020 inches to 0.024 inches. It should be understood that although some embodiments disclosed herein are described as including guidewires, any suitable guide element (e.g., guidewire, catheter, etc.) that can help navigate a catheter through human anatomical structures can also be used, wherein when the guide element is located in the lumen, the cross-sectional shape (e.g., circular) and size (e.g., diameter) of the guide element relative to the cross-sectional shape and size of the lumen of the catheter provide space in the lumen sufficient to allow the liquid to flow at a desired flow rate. The desired flow rate of the fluid can be provided in a predetermined amount of time to provide a desired amount of fluid. The desired flow rate can be a predetermined flow rate. For example, there is enough space in the lumen of the catheter to allow the contrast agent to flow through the lumen of the catheter and out of the distal end of the catheter at a certain volume under a certain amount of pressure (e.g., less than or equal to about 400 psi), even when the guide element is located in the lumen. Therefore, unless the context and / or the specific use of the term indicates otherwise, the terms guidewire and guide element can be used interchangeably. 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 reinforcement layer of stainless steel wire surrounding part or all of the lumen. In some embodiments, the guidewire can have a hydrophilic coating.

[0008] According to another aspect of the present disclosure, a method for delivering a fluid to a target site of a patient's vascular system is also provided, comprising: navigating a guide wire to the target site, navigating the lumen of a catheter above the guide wire until the distal end of the catheter is located at the target site, connecting the proximal end of the catheter to a fluid pump or an injector, and pumping the fluid through the proximal end of the catheter, pumping along an annular lumen, and pumping the fluid to the target site from the distal end. 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 agent. In some embodiments, the guide wire can have a diameter of 0.018 inches, 0.020 inches, or a diameter of 0.018 inches to 0.020 inches. In some embodiments, the guide wire can have a diameter of 0.024 inches, or a diameter of 0.020 inches to 0.024 inches. In some embodiments, the guidewire can have a diameter of 0.014 inches, 0.018 inches, or 0.014 inches to 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 also include a braided reinforcement layer of stainless steel wire. In some embodiments, the guidewire can have a hydrophilic coating.

[0009] Another innovation includes a system for delivering a fluid to a target site in a patient's vasculature, the system comprising a catheter including a tubular catheter shaft having a proximal end, a distal end, and a lumen defined by an inner surface of the catheter shaft, the inner surface extending longitudinally through the catheter shaft between the proximal and distal ends; a guide element having a distal end, a proximal end, and an outer surface, the guide element configured to be positioned in the lumen to create an area between the outer surface of the guide element and the inner surface of the catheter, the area having an effective cross-sectional area for fluid communication of greater than or equal to about 0.001257 square inches, the system configured to move the catheter and guide element so that the guide element and the distal end of the catheter are advanced toward the target site while the guide element is at least partially within the lumen of the catheter; and a contrast agent pump connected to the catheter (in fluid communication with the lumen), the system configured to actuate the contrast agent pump to pump the contrast agent at a pump pressure of less than or equal to about 400 psi, while the guide element is at least partially located in the lumen of the catheter, so that the provided contrast agent propagates along the outer surface of the guide element through the lumen of the catheter and flows out of the distal end of the catheter, wherein the effective cross-sectional area allows the contrast agent to flow out of the distal end of the catheter at a predetermined flow rate. In some examples, the fluid is some fluid other than the contrast agent. In some embodiments, the predetermined flow rate is 3 cc's per second, or about 3 cc's per second. In some embodiments, the predetermined flow rate is at least 3 cc's per second. In some embodiments, the effective cross-sectional area (in the lumen when the guide element is at least partially located in the catheter) can be annular or eccentric annular. In some embodiments, the effective cross-sectional area can be greater than or equal to about 0.001257 square inches, which provides a channel in the lumen to allow the fluid (e.g., contrast agent) to communicate through the catheter and flow out of 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 in the lumen for fluid (e.g., contrast agent) to be communicated through the catheter and flow out of the distal end of the catheter at a desired flow rate. In an example, the desired flow rate is at least about 2 cc's per second. In another example, the desired flow rate is at least about 3 cc's per second. The guiding element can be, for example, a guide wire, 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 of about 0.014 inches to about 0.020 inches. In some examples, the diameter of the lumen of the catheter (i.e., the inner diameter of the catheter) is about 0.045 inches or about 0.049 inches, or the diameter of the lumen of the catheter is about 0.045 inches to 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, and the hypotube can be a laser-cut hypotube. In some examples, the catheter includes a braided reinforcement layer of stainless steel wire surrounding at least a portion of the lumen. In some embodiments of a system with 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 so that the guiding element, the first catheter, the second catheter, and the third catheter are concentrically arranged so that when the contrast agent is provided through the lumen of the first catheter, at least a portion of the guiding element, the first catheter, and the second catheter are inside the third catheter. In some embodiments, the guiding element includes a hydrophilic coating.

[0010] 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 an introducer element toward the target site; moving the distal end of the catheter toward the target site while at least a portion of the introducer element is positioned within a lumen of the catheter; and providing a contrast agent to the proximal end of the catheter while at least a portion of the introducer element is positioned within the lumen of the catheter, such that the provided contrast agent propagates along an outer surface of the introducer element, through the lumen, and out of the distal end of the catheter, wherein the lumen and the introducer element are sized to create an area between the outer surface of the introducer element and the inner surface of the catheter that provides a predetermined flow rate of contrast agent out of the distal end of the catheter at a pump pressure of less than or equal to 400 psi. The flow rate of the fluid is affected by the pump pressure and the effective cross-sectional area. Thus, at 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's per second or approximately 3 cc's per second. In some embodiments, the effective cross-sectional area is sized so that the predetermined flow rate is at least about 3 cc's per second. In an example, the desired flow rate is at least about 2 cc's per second. In some embodiments, the effective cross-sectional area is annular, or the effective cross-sectional area is eccentrically annular. 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 guide element has a diameter of about 0.014 inches or about 0.020 inches, or the guide element has a diameter of about 0.014 inches to about 0.020 inches. In some examples, the diameter (inner diameter) of the lumen of the catheter is about 0.045 inches or about 0.049 inches, or the diameter (inner diameter) of the lumen of the catheter is about 0.045 inches to about 0.049 inches. In some embodiments, the distal end of the catheter is thermoformed. The method can also include providing a contrast agent while moving at least one of the guiding element or the catheter toward the target site. In some embodiments, the catheter is a first catheter and a second catheter and a third catheter, and the second catheter and the third catheter are positioned so that the guiding element, the first catheter, the second catheter and the third catheter are concentrically arranged so that when the contrast agent is provided through the lumen of the first catheter, at least a portion of the guiding element, the first catheter and the second catheter are inside the third catheter. In some embodiments, the guiding element is connected to a first hub and the catheter is connected to a second hub, the first hub is magnetically connected to a first pulley of the drive assembly by a sterile barrier, the second hub is magnetically connected to a second pulley of the drive assembly by a sterile barrier, and wherein moving the distal end of the guiding element and the distal end of the catheter includes moving the first pulley and moving the second pulley. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 is a schematic perspective view of an interventional setup with an imaging system, a patient support table, and a robotic drive system according to the present disclosure.

[0012] Figure 2 is a longitudinal cross section showing the concentric relationship between a guidewire with two degrees of freedom, an access catheter with three degrees of freedom, and a guiding catheter with one degree of freedom.

[0013] Figure 3A Schematic diagram of an exploded view of the interventional device hub separated from the support platform by a sterile barrier.

[0014] Figures 3B to 3F An alternative sterile barrier is shown in the form of a transport tray having one or more storage channels for carrying interventional devices.

[0015] Figures 3G to 3K An embodiment of an alternative sterile barrier is shown having a raised drive deck.

[0016] Figure 3L and Figure 3M Describes the Figures 3G to 3K Example of a hub used with a sterile barrier.

[0017] Figure 4 is a schematic elevational cross section through a hub adapter with a driving magnet separated from an interventional device hub and a driven magnet by a sterile barrier.

[0018] Figure 5A and Figure 5B A three- and four-interventional device assembly is schematically shown.

[0019] Figure 6 is a perspective view of the support table.

[0020] Figure 7 Here is a close-up view of the engine drive end of the support table.

[0021] Figure 8 is an elevation cross section through the engine and belt drive assembly.

[0022] Figure 9 It is a close-up view of the pulley end of the support table.

[0023] Figure 10 It is a vertical cross section through the pulley.

[0024] Figure 11 is throughout, for example Figure 5A and Figure 5BElevated cross-sections of the distal portions of those catheters shown in .

[0025] Figure 12A and Figure 12B A force sensor integrated into the side wall of a catheter is schematically shown.

[0026] Figure 13A and Figure 13B A sensor for measuring the spring force of the magnetic connection between the hub and the corresponding trolley is schematically shown.

[0027] Figure 14 A dual encoder torque sensor for use with the catheter of the present disclosure is schematically shown.

[0028] Figure 15 A clot capture and visualization device is shown that may be integrated into the hub and / or connected to the aspiration line.

[0029] 16A to 16C Exemplary control mechanisms for steering interventional devices driven by corresponding hubs are shown.

[0030] Figure 17 Shown is a schematic side elevation view of an interventional device assembly for supra-aortic access and neurointerventional procedures.

[0031] Figure 18 Shown are side cross-sectional views of examples of two catheters in which at least a portion (eg, the tip) of the catheter is a laser-cut hypotube.

[0032] Figure 19 An enlarged view of an example of a laser cut hypotube is shown.

[0033] Figures 20A to 20E Depicted is an example sequence of steps for introducing a catheter assembly configured to achieve supra-aortic access and neurovascular access.

[0034] Figure 21 An embodiment of the mechanical connection between the driver component and the driven machine component is shown schematically.

[0035] Figures 22A to 22C An example sequence of steps for priming a catheter assembly in a stacked configuration is depicted.

[0036] FIG. 23A to FIG. 23B An example sequence of steps for priming a catheter assembly in a stacked configuration is depicted.

[0037] Figure 24 Describes the use FIG. 23A to FIG. 23B An example test system for the priming process depicted in FIG.

[0038] Figure 25AAn example of a catheter assembly is shown.

[0039] Figure 25B An example of a catheter assembly after a priming procedure is shown.

[0040] Figure 25C An example of a catheter assembly is shown after a priming procedure involving relative movement between adjacent catheters.

[0041] Figures 25D to 25F Shown Figures 25A to 25C Example catheter assembly.

[0042] Figure 26A One embodiment of a one-way channel fluid management system is shown.

[0043] Figure 26B One embodiment of a three-channel fluid management system is shown.

[0044] Figure 27 A schematic diagram showing an example of a three-channel fluidic system.

[0045] Figure 28 Another schematic diagram of an example of a fluid system is shown.

[0046] Figure 29 Another schematic diagram of an example of a fluid system is shown.

[0047] Figure 30 An example of an embodiment of a fluid system is shown.

[0048] Figure 31 An example of an embodiment of a brine subsystem is shown.

[0049] Figure 32 An example of an embodiment of a contrast agent subsystem is shown.

[0050] Figure 33 An example of an implementation of a vacuum / aspiration ("V / A") subsystem ("vacuum subsystem") is shown.

[0051] Figure 34 An example of a catheter of an embodiment connected to a hub is shown, and a tubing set connected to the hub at a distal end and to a cassette at a proximal end, wherein the tubing set includes saline tubing, contrast tubing, and vacuum tubing, and may include electrical connections, wherein the tubing set forms part of a fluid communication system connecting the hub to a saline subsystem, a contrast subsystem, and a vacuum subsystem.

[0052] Figure 35 Another example of a catheter connected to an embodiment of a hub is shown.

[0053] Figure 36An example of a tubing set is shown, which is part of a fluid communication system that provides a passage for communicating substances (e.g., air, fluids, and / or materials) between multiple catheters and a saline subsystem, a contrast agent subsystem, and a vacuum subsystem, the tubing set being connected to a box on a proximal end of the tubing set and to multiple hubs on a distal end of the tubing set, and in this example, the tubing set also includes electrical connections between the box and the multiple hubs.

[0054] According to some embodiments, Figure 37 A schematic diagram of an example of a robotic catheter system including a remotely located system (“remote system”) and a locally located system (“local system”) is shown, and examples of certain components of the local system are shown, including certain components of a fluid management system (“fluid system”), including actuatable components that are actuated by a controller and sensors that provide information to the controller for controlling the fluid system and other aspects of the robotic catheter system.

[0055] Figure 38 An example of an embodiment of a cassette and a pump station is shown, illustrating certain components of the cassette (eg, valves, electrical connections) and corresponding pump station components (eg, motor, electrical connections).

[0056] Figure 39 Examples of contrast media injection steps that may be performed when the fluid system is in a contrast media injection state are shown.

[0057] Figure 40 The steps for determining whether it is safe for the system to inject contrast media are shown.

[0058] Figure 41 An example of a contrast agent subsystem configuration is shown, wherein an insertion catheter connected to a hub is selected for injection of contrast agent.

[0059] Figure 42 An example of the configuration of the hub corresponding to a selected catheter when injecting contrast agent is shown.

[0060] Figure 43 An example of the configuration of the hub of a selected catheter configured to inject a saline bolus is shown.

[0061] Figure 44 An overview of an example experimental procedure for a contrast injection study is shown.

[0062] Figure 45 is a graphical representation of the relationship between flow rate and catheter length.

[0063] Figure 46 is a graphical representation of the relationship between flow rate and guidewire diameter.

[0064] Figure 47 is a graphical representation of the relationship between output flow rate and input flow rate.

[0065] Figure 48 is a graphical representation of the relationship between output flow rate and injection volume.

[0066] Figure 49 It is a graphic representation of the relationship between pressure, flow rate and viscosity.

[0067] Figure 50 A schematic diagram depicts an example of a control system.

[0068] Figure 51 Depicted is the setup of an example test system for glycerol viscosity testing.

[0069] Figure 52 is a representation of an example of a distal end view of a concentric stack including a guide catheter, a surgical catheter, an insertion catheter, and a guiding element (eg, a guidewire). DETAILED DESCRIPTION

[0070] In certain embodiments, a system is provided for advancing a guide catheter from the femoral or radial artery into the ostium of one of the great vessels at the top of the aortic arch, thereby achieving supra-aortic access. The surgeon can then take the interventional device via the robotically placed guide catheter and advance it into the cerebral vasculature.

[0071] In some embodiments, the system can additionally be configured to robotically gain intracranial vascular access and perform aspiration thrombectomy or other neurovascular procedures.

[0072] The drive platform can be located above or to one side of the patient and is configured to axially advance, retract, and in some cases rotate and / or laterally deflect two or three or more different (e.g., concentrically or side-by-side oriented) intravascular devices. The hub can move along a path along the surface of the drive platform to advance or retract the interventional device as needed. Each hub can also contain a mechanism to rotate or deflect the device as desired and be connected to a fluid delivery tube (not shown) of the type conventionally attached to a catheter hub. Each hub can be in electrical communication with an electronic control system via a hardwired connection, an RF wireless connection, or a combination of both.

[0073] 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 connected to a unique drive trolley 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 the corresponding interventional device proximally or distally within the patient's vascular system.

[0074] The pulley on the drive stage that is magnetically connected to the hub to provide linear motion actuation is universal. The catheter / guidewire functionality is provided based on what is included in the hub and shaft design. This allows the system to be flexibly configured to perform a wide range of surgeries using a variety of interventional devices on the same drive stage. In addition, the interventional devices and methods disclosed herein can be easily adapted for use with a variety of other drive systems (e.g., any of a variety of robotic surgical drive systems).

[0075] Figure 1 is a schematic perspective view of an interventional device 10 having a patient support table 12 for supporting a patient 14. An imaging system 16 may be provided along with a robotic interventional device drive system 18 according to the present disclosure.

[0076] The drive system 18 may include a support platform 20 for supporting, for example, a guidewire hub 26, an access catheter hub 28, and a guide catheter hub 30. In the context of this document, the term "access" catheter may be any catheter having a lumen with at least one distal or laterally facing distal opening that can be used to aspirate thrombus, provide a passage for additional devices to be advanced therethrough or along, or infuse saline or contrast or therapeutic agents.

[0077] 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 the guidewire hub 26 and access catheter hub 28 for driving a guidewire and an access catheter (in the form of a diagnostic angiography catheter). A plurality of interventional devices 22 extend between the support table 20 and a femoral access point 24 on the patient 14 (in the example shown). Depending on the desired procedure, access may be achieved by percutaneous or open access into any of a variety of arteries or veins, such as the femoral artery or radial artery. Although disclosed herein primarily in the context of neurovascular access and surgery, the robotic drive systems and associated interventional devices can be readily configured for a wide variety of additional medical interventions in the peripheral and coronary arterial and venous vascular systems, the gastrointestinal system, the lymphatic system, cerebrospinal fluid cavities or spaces (e.g., the spinal canal, ventricles, and subarachnoid space), the pulmonary airways, treatment sites reached via transureteral or urethral or fallopian tube navigation, or other hollow organs or structures in the body (e.g., in intracardiac or structural heart applications, such as valve repair or replacement, or in any endovascular procedure).

[0078] A display 23 (e.g., for viewing fluoroscopic images, catheter data (e.g., Fiber Bragg sensor data or other force or shape sensing data), or other patient data) can be carried by the support table 20 and / or the patient support 12. Alternatively, the physician input / output interface including the display 23 can be remote from the patient, such as behind radiation shielding, in a different room from the patient, or in a different facility from the patient.

[0079] In the example shown, a guidewire hub 26 is carried by the support table 20 and is movable along the table to advance a guidewire into and out of the patient 14. An access catheter hub 28 is also carried by the support table 20 and is movable along the table to advance an access catheter into and out of the patient 14. The access catheter hub can also be configured to rotate the access catheter in response to operation of a rotation control and can also be configured to laterally deflect a deflectable portion of the access catheter in response to operation of a deflection control.

[0080] Figure 2 is a longitudinal cross section schematically illustrating the kinematic relationship between a guidewire 27 having two degrees of freedom (axial and rotational), an access catheter 29 having three degrees of freedom (axial, rotational, and lateral deflection), and a guide catheter 31 having one degree of freedom (axial).

[0081] refer to Figure 3A The support platform 20 includes drive mechanism components, described in more detail below, to independently drive the guidewire hub 26, the access catheter hub 28, and the guide catheter hub 30. An anti-buckling feature 34 can be provided in the proximal anti-buckling region for resisting buckling of the portion of the interventional device that spans the distance between the support platform 20 and the femoral artery access point 24. The anti-buckling feature 34 can include a plurality of concentric, telescopically extending and collapsible tubes through which the interventional device extends.

[0082] Alternatively, the proximal section of one or more device shafts can be configured to have enhanced stiffness to reduce buckling during compression. For example, the proximal reinforced segment can extend from the hub to a distance of at least about 5 cm or 10 cm distally, but typically no more than about 120 cm or 100 cm, to support the device between the hub and the entry point 24 on the patient. Reinforcement can be achieved by using a metal or polymer tube or embedding at least one or two or more axially extending elements into the wall of the device shaft, such as a long wire or ribbon. In some embodiments, the extension element can be hollow and prevent wear, buckling or damage at the input and output of the hub. In some embodiments, the hollow extension element can be a hollow and flexible covering layer attached to the hub. The hollow extension element (e.g., a hollow and flexible covering layer) can cover a portion of the device shaft when passing through the hub. In some embodiments, the hollow extension element is a set of telescopic parts that are nested in each other and surround the shaft between the hubs. In some embodiments, the hollow extension element has a proximal end (closest to the insertion point) and a distal end (farthest from the insertion point), and each end is connected to the hub. In some embodiments, the extension element is releasably connected to the hub at at least one end. In some embodiments where the hollow extension element is a covering layer, the covering layer can be attached to a portion of the hub so that passing the catheter device through the hub 26, 28 or 30 also passes the catheter device through the covering layer. In some embodiments, an anti-buckling device can be mounted on or around the device axis 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, a telescoping tube, a split tube with tension, etc.

[0083] In some embodiments, multiple deflection sensors can be placed along the length of the catheter to identify buckling. Buckling can be identified by sensing that the hub is advanced distally without movement of the distal tip of the catheter or interventional device. In some embodiments, buckling can be detected by sensing that energy loading has occurred between the catheter shafts (e.g., due to friction).

[0084] Alternatively, a thin tubular reinforcement structure can be embedded in the device wall or continue on the outside of the device wall, such as a tubular polymer extrusion or a section of hypotube. Alternatively, a removable reinforcement mandrel can be placed in the lumen in the proximal section of the device and removed from the proximal end after the hub is advanced distally toward the patient access position to prevent buckling of the proximal shaft during distal advancement of the hub. Alternatively, the proximal section of one or more device shafts can be configured as a tubular hypotube, which can be machined (e.g., with a laser) so that its mechanical properties vary along its length. The proximal section can be formed of stainless steel, nitinol and / or cobalt-chromium alloy, optionally in combination with a polymer component that can provide lubricity and hydraulic sealing. In some embodiments, the proximal section can be formed of a polymer, such as polyetheretherketone (PEEK). Alternatively, the wall thickness or diameter of the interventional device can be increased in the anti-buckling region.

[0085] In certain embodiments, a device shaft having a high degree of stiffness (e.g., axial and torsional) can provide improved motion transfer from the proximal end of the device shaft to the distal end of the device shaft. For example, the device shaft can be more responsive to motion applied at the proximal end. Such an embodiment may be advantageous for robotic actuation without tactile feedback to the user.

[0086] In some embodiments, a flexible covering can be applied to the device shaft and / or hub to reduce friction between the device shaft and / or hub and the second device shaft as the second device shaft passes through the device shaft and / or hub and the second device shaft.

[0087] The interventional device hub can be separated from the support table 20 by a sterile barrier 32. The sterile barrier 32 may comprise a thin plastic film, such as polyethylene terephthalate (PET), polyethylene terephthalate glycol copolymer (PETG), polyethylene terephthalate glycol (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 the associated drive system to be located on the non-sterile (lower) side of the sterile barrier 32. The guidewire hub 26, entry catheter hub 28, guide catheter hub 30 and the associated interventional device are all on the sterile (upper) side of the sterile barrier 32. The sterile barrier is preferably waterproof and can also be used as a tray used in the packaging of the interventional device, which will be discussed further below. The interventional device can be provided separately or as a coaxial preassembled kit that is transported and stored in a tray and packaged in sterile packaging.

[0088] Figures 3B to 3FSchematically illustrated is an optional sterile barrier and a transport tray, which serves as a dual-function sterile barrier placed on a support table during an interventional procedure. The transport tray has one or more storage channels for carrying sterile interventional devices. The sterile barrier can also serve as a sterile work surface for preparing catheters or other devices during the procedure.

[0089] refer to Figure 3B and Figure 3C , a sterile barrier 32 is shown in the form of a pre-formed tray for mounting the elongated support table 20. In use, the elongated support table 20 will be located below the sterile barrier 32. The sterile barrier 32 extends between a proximal end 100 and a distal end 102 and includes an upper support surface 104 for supporting an interventional device hub. In one embodiment, in a linear drive configuration, the support surface 104 has an axial length that is greater than the length of the intended interventional device.

[0090] The length of the support surface 104 will typically be at least about 100 centimeters, and within the range of about 100 centimeters to about 2.7 meters. Shorter lengths may be used in systems configured to propel a drive connector along an arcuate path. In some embodiments, two or more support surfaces may be used instead of a single support surface 104. The two or more support surfaces may have a combined length of 100 centimeters to about 2.7 meters. The width of the linear drive table is preferably no more than about 30 centimeters to about 80 centimeters.

[0091] At least a first channel 106 may be provided that extends axially for at least a portion of the length of the support platform 20. In the embodiment shown, the first channel 106 extends the entire length of the support platform 20. Preferably, the first channel 106 has sufficient length to accommodate the interventional device and has sufficient width and depth to accommodate the corresponding hub (e.g., by providing lateral support to prevent the hub from moving out when force is applied to the hub). The first channel 106 is defined within the base 108, the outer side wall 110, and the inner side wall 111, forming an upward-facing concave shape. Optionally, a second channel 112 may be provided. The second channel 112 may be located on the same side of the upper support surface 104 or on the opposite side as the first channel 106. Two or three or more additional recesses (e.g., additional channels or holes) may be provided to accommodate additional medical devices or supplies useful during the interventional procedure, as well as to collect fluids and serve as a wash basin for catheters and related equipment.

[0092] refer to Figure 3D, guide catheter hub 30 is shown positioned on upper support surface 104 and magnetically connected to a corresponding connector housing a drive magnet, which connector is positioned below sterile barrier 32. Access catheter hub 28 and access catheter 29, as well as guidewire hub 26 and guidewire 27 are shown positioned within first channel 106, e.g., prior to introduction through guide catheter 31 or after removal from guide catheter 31.

[0093] The interventional devices can be located within the channel 106 and enclosed within the sterile barrier for transport. At the clinical location, the upper panel of the sterile barrier can be removed, or the tubular sterile barrier packaging can be opened and axially removed from the support table 20 and sterile barrier assembly 32, exposing the sterile top side of the sterile barrier tray and any included interventional devices. The interventional devices can be carried individually in the channel or preassembled into an access assembly or surgical assembly, which will be discussed in additional detail below.

[0094] Figures 3D to 3F A support table is shown with a sterile barrier in place and Figure 3E In the present invention, the interventional device is configured in the entry assembly for aortic entry after the entry assembly is connected to the corresponding pulley below the sterile barrier. The entry assembly can be preassembled, wherein the guide wire is fully advanced through the entry catheter, and the entry catheter is fully advanced through the guiding catheter in turn. In the entry catheter or other conduit is preformed (that is, pre-bent or not straight) embodiment, the guide wire and / or outer conduit can be positioned so that the relatively hard part does not overlap with the harder part of the bend of the preformed conduit, for example, to avoid the creep of the preformed conduit or straightening and / or the bending is introduced into other straight conduits. The entry assembly can be lifted out of channel 106 and positioned on the support surface 104, for being connected to the corresponding driving magnet and being introduced into the patient's body. The guiding catheter hub 30 is the most distal hub. The entry catheter hub 28 is located at the proximal end of the guiding catheter hub so that the entry catheter 29 can extend to the distal end by the guiding catheter. The guide wire hub 26 is located at the most proximal end, so as to allow the guide wire 27 to advance through the entry catheter 29 and the guiding catheter 31.

[0095] Figure 3F The surgical assembly is shown after being introduced through a guide catheter 31 for achieving supra-aortic access. In this embodiment, the guide catheter 31 is retained at the distal-most end of the interventional device. A first surgical catheter 120 and a corresponding hub 122 are shown extending through the guide catheter 31. An optional second surgical catheter 124 and a corresponding hub 126 are shown extending through the first surgical catheter 120. A guidewire 27 extends through at least a portion of the second surgical catheter 124 in a rapid exchange version, or through the entire length of the second surgical catheter 124 in an over-the-wire embodiment.

[0096] If combined Figure 17 As discussed in more detail, multiple catheter stacks can be utilized to facilitate access and endovascular procedures without the need to change catheters. This can be accomplished in manually or robotically driven procedures. In some embodiments, determining a suitable catheter stack, each having a certain size, and a fluid system configured to utilize the configuration of the catheter stack for contrast agent injection facilitates access, endovascular procedures, and contrast agent injection without the need to change catheters. In one example, the guide catheter 31 can include a catheter having an inner diameter of at least approximately 0.08 inches, and in one embodiment, an inner diameter of approximately 0.088 inches. The first surgical catheter 120 can include a catheter having an inner diameter of approximately 0.065 inches to approximately 0.075 inches, and in one embodiment, the catheter 120 has an inner diameter of approximately 0.071 inches. The second surgical catheter 124 can be an access catheter having an OD size that allows advancement through the first surgical catheter 120. The second surgical catheter can be steerable, having a deflection control 2908 configured to laterally deflect the distal end of the catheter. The second surgical (access) catheter may also have a lumen sized to allow a guidewire of appropriate size to be retained inside the second surgical catheter while contrast media is injected through the second surgical catheter.

[0097] In certain embodiments, catheter 31 can be a "large bore" access catheter or guide catheter having an inner diameter of at least about 0.075 inches or an inner diameter of at least about 0.080 inches. Catheter 120 can be an aspiration catheter having an inner diameter 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 of about 0.025 inches to about 0.050 inches. Guidewire (or guiding element) 27 can have an outer diameter 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 may have an inner diameter of approximately 0.088 inches, catheter 120 may have an inner diameter of approximately 0.071 inches, catheter 124 may have an inner diameter of approximately 0.045 inches, and guidewire 27 may have an outer diameter of approximately 0.018 inches.

[0098] In one commercial implementation, a preassembled access assembly (a guide catheter, an access catheter, and a guidewire) can be carried in a first channel on a sterile barrier tray, and a preassembled surgical assembly (one or two surgical catheters and a guidewire) can be carried in the same or a different second channel on the sterile barrier tray. One or two or more additional catheters or interventional tools can also be provided, depending on potential needs during the interventional procedure.

[0099] Figures 3G to 3K An embodiment of an alternative sterile barrier having a raised drive deck (eg, a raised, crowned road-like drive deck) is shown. Figure 3G 2 is a cross-sectional view of sterile barrier 232. Sterile barrier 232 includes a raised upper support surface 204. Fluid channels 205 and 207 are located laterally and below support surface 204 for automatically clearing or draining fluid from support surface 204 (e.g., during an interventional procedure). Fluid channels 205 and 207 can extend axially for at least a portion of the length of the sterile barrier.

[0100] Figure 3I 、 Figure 3J and Figure 3K A perspective cross-sectional view, a cross-sectional view, and a top cross-sectional view of the proximal end of the sterile barrier 232 are shown, respectively. Figures 3I to 3K As shown, the sterile barrier 232 can include a groove 240 in communication with the fluid channels 205 and 207. The groove 240 can receive fluid from the channels 205 and 207 (e.g., during an interventional procedure). The groove 240 can be at least partially located below the fluid channels 205 and 207 so that the fluid in the channels 205 and 207 flows into the groove 240. In some embodiments, the fluid channels 205 and 207 can be angled relative to the horizontal plane (e.g., can descend from the end of the channel farthest from the groove 240 to the groove 240) so that the fluid in the channels 205 and 207 is directed to the groove 240. For example, the depth of the channels 205 and 207 can increase from the end of the channel farthest from the groove 240 to the groove 240. Alternatively, during a portion or all of the interventional procedure, sterile barrier 232 and / or the support table can be positioned at an angle relative to the horizontal plane such that the ends of channels 205 and 207 furthest from slot 240 are positioned above slot 240. For example, sterile barrier 232 and / or the support table can be constructed or arranged at an angle such that the ends of sterile barrier 232 and / or the support table opposite slot 240 are positioned above slot 240. Alternatively or additionally, the drive mechanism can temporarily tilt sterile barrier 232 and / or the support table such that the ends of sterile barrier 232 and / or the support table opposite slot 240 are positioned above slot 240 (e.g., by raising the ends of sterile barrier 232 and / or the support table opposite slot 240 or lowering the ends of sterile barrier 232 and / or the support table at slot 240), thereby allowing fluid within channels 205 and 207 to flow into slot 240.

[0101] The tank 240 may include a drain hole 242. The tank 240 may be shaped, sized, and / or configured in other ways as desired so that the fluid in the tank 240 drains into the drain hole 242. The drain hole 242 may include a pipe, a barbed fitting, and / or an on-off valve for removing the fluid from the tank 240. Figures 3I to 3K As shown, the trough 240 can be located at the proximal end of the sterile barrier 232. In alternative embodiments, the trough 240 can be located at the distal end of the sterile barrier 232. In some embodiments, the sterile 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 serve as a wash basin.

[0102] The first channel 206 can extend axially for at least a portion of the length of the sterile barrier 232. The channel 206 can have sufficient length to accommodate the interventional device and sufficient width and depth to accommodate the corresponding hub (e.g., by providing support to prevent the hub from being dislodged when force is applied to the hub). Optionally, a second channel 212 can be provided. The second channel 212 can be located on the same side of the upper support surface 204 as the first channel 206 or on the opposite side. Figure 3G Channel 212 is shown on the opposite side of support surface 204 from channel 206 . Figure 3H is a cross-sectional view illustrating an alternative embodiment of sterile barrier 232 in which channel 212 is on the same side of support surface 204 as channel 206 .

[0103] like Figure 3G and Figure 3H As shown, channels 206 and 212 can have generally triangular, wedge-shaped or other angled cross-sections to accommodate the hub at an angle relative to the horizontal plane. Accommodating the hub at an angle relative to the horizontal plane can allow for a smaller width of the sterile barrier 232.

[0104] Two or three or more additional recesses (eg, additional channels or holes) may be provided to accommodate additional medical devices or supplies that may be useful during the interventional procedure, as well as to collect fluids and serve as wash basins for catheters and related equipment.

[0105] In some embodiments, the sterile barrier 232 can include one or more structural ribs 236. The sterile barrier 232 can also include one or more frame support protrusions 228 and 238.

[0106] exist Figure 3G In the embodiment of the sterile barrier 232 shown, the width x1 can be 14 inches, approximately 14 inches, 12 inches to 16 inches, 10 inches to 18 inches, or any other suitable width. Figure 3HIn the illustrated embodiment of sterile barrier 232, width x1 can be 15 in, approximately 15 in, 13 in to 17 in, 11 in to 19 in, or any other suitable width. Height y1 of support surface 204 can be 0.125 in, approximately 0.125 in, 0.1 in to 0.15 in, or any other suitable height. In some embodiments, support surface 204 can be recessed from top surface 233 of sterile barrier 232. Height y2 between the bottom and top surfaces 233 of support surface 204 can be 0.5 in, approximately 0.5 in, 0.25 in to 0.75 in, or any other suitable height. Width x2 from the lateral edge of channel 205 to the lateral edge of channel 207 can be 5 in, approximately 5 in, 4 in to 6 in, or any other suitable width. Width x3 of support surface 204 can be 4 in, approximately 4 in, 3 in to 5 in, or any other suitable width. The height y3 of channel 206 and / or channel 212 can be 1.5 in, approximately 1.5 in, 1 in to 2 in, or any other suitable height. The width x4 of channel 206 and / or channel 212 can be 3 in, approximately 3 in, 2 in to 4 in, or any other suitable width. Channel 206 and / or channel 212 can be defined by an arc angle α of 90°, approximately 90°, 80° to 100°, or any other suitable angle, and a radius of curvature of 0.125 in, approximately 0.125 in, 0.1 in to 0.15 in, or any other suitable radius of curvature. In certain embodiments, an arc angle α of 90° or approximately 90° can be used to accommodate a hub with a rectangular or substantially rectangular cross-section. Support surface 204 can be defined by a radius of curvature of 13 in, approximately 13 in, 11 in to 15 in, or any other suitable radius of curvature. Channel 205 and / or channel 207 may be defined by a radius of curvature of 0.25 in, approximately 0.25 in, 0.15 in to 0.35 in, or any other suitable radius of curvature.

[0107] Figure 3L and Figure 3M Describes how Figures 3G to 3KThe example dimensions of the hub 250 used together with the sterile barrier 232 shown in FIG. The hub 250 can be any hub described herein. In certain embodiments, the hub 250 can have a width w1 of 3.75 in, approximately 3.75 in, 3.25 in to 4.25 in, or any other suitable width. The hub 250 can have a height h1 of 1.5 in, approximately 1.5 in, 1.25 in to 1.75 in, or any other suitable height. Alternatively, the hub 250 can have a height h2 of 2 in, approximately 2 in, 1.75 in to 2.25 in, or any other suitable height. In some embodiments, the hub 250 can have a length L1 of 2.5 in, approximately 2.5 in, 2 in to 3 in, or any other suitable length. Alternatively, the hub 250 can have a length L2 of 4 in, approximately 4 in, 3.5 in to 4.75 in, or any other suitable length.

[0108] In some embodiments, the top surface of the support table can include surface features that generally correspond to the surface features of the sterile barrier 232. For example, the support table can include a raised surface configured to correspond to the shape, size, and location of the support surface 204 and / or one or more recessed portions configured to correspond to the shape, size, and location of the channels 205 and 207.

[0109] In an optional embodiment, the planar support surface (e.g., support surface 104 of sterile barrier 32) can be positioned at an angle to the horizontal plane to facilitate the discharge of fluid. In some embodiments, the sterile barrier and / or support table can be positioned at an angle relative to the horizontal plane to facilitate the discharge of fluid during a portion or the entire interventional procedure. For example, the sterile barrier and / or support table can be constructed or arranged to be arranged at an angle (e.g., such that one lateral side of the planar support surface is higher than the other lateral side of the planar support surface, the proximal end is higher than the distal end, or the distal end is positioned higher than the proximal end) to facilitate the discharge of fluid. Alternatively or additionally, the drive mechanism can temporarily tilt the sterile barrier and / or support table (e.g., such that one lateral side of the planar support surface is higher than the other lateral side of the planar support surface, the proximal end is higher than the distal end, or the distal end is positioned higher than the proximal end) to facilitate the discharge of fluid. For example, the drive mechanism may raise or lower a lateral side of the sterile barrier and / or support table, a proximal end of the sterile barrier and / or support table, and / or a distal end of the sterile barrier and / or support table.

[0110] In certain embodiments, the support surface (e.g., support surface 104 of sterile barrier 32) can be positioned in a vertical configuration, rather than, for example, Figures 3A to 3FFor example, the support surface 104 can be positioned at approximately 90 degrees (or any other suitable angle) to the horizontal plane (e.g., relative to Figures 3A to 3F 104 is rotated 90 degrees about the long axis of the support surface 104). The vertical configuration can also provide easier physician interaction with the drive system 18. The vertical configuration can also provide the lower shaft of the catheter being advanced closer to the patient without increasing the standoff height of the drive system 18.

[0111] In some embodiments, the drive system 18 can be positioned at an angle to the horizontal plane during part or all of the interventional procedure to facilitate drainage of the fluid. For example, the drive system 18 can be configured or arranged in an angled arrangement (e.g., such that one lateral side of the planar support surface is higher than the other lateral side of the planar support surface, the proximal end is higher than the distal end, or the distal end is positioned higher than the proximal end) to facilitate drainage of the fluid. Alternatively or additionally, the drive mechanism components can temporarily tilt the drive system 18 (e.g., such that one lateral side of the drive system 18 is higher than the other lateral side of the drive system 18, the proximal end is higher than the distal end, or the distal end is positioned higher than the proximal end) to facilitate drainage of the fluid. For example, the drive mechanism components can raise or lower a lateral side of the system 18, the proximal end of the drive system 18, and / or the distal end of the drive system 18. In some embodiments, the drive system 18 can be angled so that it extends at an angle away from the axis point 24 (e.g., such that the proximal end is higher than the distal end), for example, to provide clearance for the patient's foot.

[0112] refer to Figure 4 , the hub 36 can represent any hub described previously. The hub 36 includes a housing 38 extending between a proximal end 40 and a distal end 42. An interventional device 44, which can be any interventional device disclosed herein, extends distally from the hub 36 and enters the patient 14 (not shown). A hub adapter 48 or pulley acts as a shuttle by advancing proximally or distally along a track in response to operator instructions or controller operation. The hub adapter 48 includes at least one drive magnet 67 configured to be connected to a driven magnet 69 carried by the hub 36. This provides a magnetic connection between the drive magnet 67 and the driven magnet 69 through the sterile barrier, so that the hub 36 moves on top of the sterile barrier 32 in response to the movement of the hub adapter 48 outside the sterile area. The movement of the hub adapter is driven by a drive system carried by the support table and is described in additional detail below. The hub adapter can serve as a robotic drive for the interventional device connected thereto.

[0113] In order to reduce friction in the system, the hub 36 can be equipped with at least a first roller 53 and a second roller 55, which can be in the form of wheels or rotatable balls or drums. The rollers separate the sterile barrier from the surface of the driven magnet 69 by at least about 0.02 cm (about 0.008 inches), and generally do not exceed about 0.08 cm (about 0.03 inches). In some embodiments, the gap is in the range of about 0.03 cm (about 0.010 inches) to about 0.041 cm (about 0.016 inches). The gap between the driving magnet 67 and the driven magnet 69 is generally no more than about 0.38 cm (about 0.15 inches), and in some embodiments no more than about 0.254 cm (about 0.10 inches), for example, in the range of about 0.216 cm (about 0.085 inches) to about 0.229 cm (about 0.090 inches). The hub adapter 48 may similarly be equipped with at least a first hub adapter roller 59 and a second hub adapter roller 63, which may be positioned relative to the corresponding first roller 53 and second roller 55, as shown in FIG. Figure 4 shown.

[0114] refer to Figure 6 , schematically illustrates one example of a low-profile linear drive support table 20. The support table 20 includes an elongated frame 51 extending between a proximal end 52 and a distal end 54. At least one support table support 56 is provided to stabilize the support table 20 relative to a patient (not shown). The support 56 may include one or more legs, or preferably, an articulated arm configured to allow the frame 51 to be moved and positioned above or near the patient.

[0115] Figure 7 The example of the linear drive table 20 shown includes three different drives. However, depending on the desired clinical performance, two drives or four or more drives (e.g., up to eight drives) can be included. A first drive pulley 58 is engaged with a first drive belt 60. A first pulley bracket 61 is fixed to the first drive belt 60 so that rotation of the first drive pulley 58 causes the first drive belt 60 to rotate through an elongated closed loop path. Depending on the direction of rotation of the drive pulley 58, the first pulley bracket 61 can be advanced in the proximal or distal direction along the longitudinal axis of the support table 20. In the embodiment shown, the drive pulley 58 is provided with a surface structure, such as a plurality of drive pulley teeth 62, for engaging with complementary teeth on the first drive belt 60.

[0116] The second drive pulley 64 can be engaged with a second drive belt 66 configured to axially move a second trolley bracket 68 along an axial path on the support table 20. The third drive pulley 70 can be configured to drive a third drive belt 72 to axially advance a third trolley bracket 73 along the support table 20. Each trolley bracket can be equipped with the previously discussed but not Figure 7, to form a connector for magnetically connecting to a corresponding driven magnet within the hub of the interventional device, as already discussed.

[0117] Figure 8 Schematically shows a detailed view of the drive system. Drive support 74 can be carried by frame 51 for supporting the drive assembly. Second drive pulley 64 is shown in a vertical cross section as being driven by motor 75 via rotatable shaft 76. Rotatable shaft 76 can be rotatably carried by support 74 via first bearing 78, shaft connection 80 and second bearing 79. Motor 75 can be stabilized by motor bracket 82 connected to drive support 74 and / or frame 51. The belt drive assembly for the first drive belt 60 and the third drive belt 72 can be similarly constructed and will not be described in detail herein. In some embodiments, the drive system described herein can be a foldable rack and pinion drive stage system. In such an embodiment, motor 75 can be attached to a pulley and move with the pulley.

[0118] refer to Figure 9 and Figure 10 Each of the first, second, and third drive belts extends around a corresponding first idler pulley 84, second idler pulley 86, and third idler pulley 88. Each idler pulley can be equipped with a corresponding tension bracket 90, which is configured to adjust the idler pulley in the proximal or distal direction to adjust the tension of the corresponding belt. Therefore, each tension bracket 90 is equipped with a tension adjustment member 92, such as a rotatable screw.

[0119] like Figure 10 As shown, for example, the second idler gear 86 may be carried by a rotatable shaft 94 that is rotatably fixed relative to the mounting bracket via a first bearing 96 and a second bearing 98 .

[0120] Any catheter (e.g. Figure 5A 、 Figure 5B or Figure 11 The catheter (shown in Figure 1) typically comprises an elongated tubular body extending between a proximal end and a distal functional end. The length and diameter of the tubular body depend on the desired application. For example, lengths of about 90 cm to about 195 cm or longer are typically used for femoral access percutaneous transluminal coronary applications. Intracranial or other applications may require different catheter shaft lengths depending on the vascular access site.

[0121] Any of the catheters disclosed herein can be equipped with a beveled distal tip. Figure 11, the distal catheter tip 1150 includes a tubular body 1152 including a pusher section 1154, a marker band 1156, and a proximal section 1158. An inner tubular liner 1160 can extend throughout the entire length of the distal catheter tip 1150 and can include dip-coated or extruded PTFE or other lubricating material.

[0122] Reinforcement elements 1162 (eg, braid and / or spring coils) are embedded in an outer sheath 1164, which can extend the entire length of the catheter.

[0123] The pusher section 1154 terminates distally in an inclined surface 1166 to provide a front sidewall portion 1168 having a length measured between the distal end 130 of the marker band 1156 and the distal tip 1172. In some embodiments, the entire distal tip can have a shape that prevents the tip from becoming stuck in the arterial bifurcation region. The rear sidewall portion 1174 of the pusher section 1154, in the illustrated embodiment, has an axial length that is approximately equal to the axial length of the front sidewall portion 1168, as measured from the front sidewall portion 1168 about 180 degrees around the catheter. The axial length of the front sidewall portion 1168 can be from about 0.1 mm to about 5 mm, and is typically from about 1 mm to 3 mm. The rear sidewall portion 1174 can be equal to the axial length of the front sidewall portion 1168 or at least about 0.1 mm or 0.5 mm or 1 mm or 2 mm or less shorter than the axial length of the front sidewall portion 1168, depending on the desired performance.

[0124] The inclined surface 1166 is inclined at an angle A of about 45 degrees to about 80 degrees to the longitudinal axis of the catheter. For some embodiments, the angle is about 55 degrees to about 65 degrees to the longitudinal axis of the catheter. In one embodiment, the angle A is about 60 degrees. One result of an angle A of less than 90 degrees is an elongation of the major axis of the region of the distal port, which increases the surface area of ​​the port and can enhance clot aspiration or retention. The area of ​​the inclined port is typically at least about 105% and no more than about 130% of the surface area of ​​a circular port (angle A of 90 degrees), in some embodiments, about 110% to about 125%, and in one example, about 115% of the area of ​​a corresponding circular port (angle A of 90 degrees).

[0125] In the illustrated embodiment, the axial length of the advancement section remains constant around the circumference of the catheter, such that the inclined surface 1166 is generally parallel to the distal surface 1176 of the marker band 1156. The marker band 1156 has a proximal surface that is generally transverse to the longitudinal axis of the catheter, resulting in an internal elevation view of the marker band 1156 having a right-angled trapezoidal configuration. The short sidewall 1178 is rotationally aligned with the rear sidewall portion 1174 and has an axial length of approximately 0.2 mm to approximately 4 mm, and typically is approximately 0.5 mm to approximately 2 mm. The opposing long sidewall 1180 is rotationally aligned with the front sidewall portion 1168. The long sidewall 1180 of the marker band 1156 is typically at least about 10% or 20% longer than the short sidewall 1178, and may be at least about 50%, 70%, 90%, or more longer than the short sidewall 1178, depending on the desired performance. Typically, the long sidewalls 1180 will have a length of at least about 0.5 mm or 1 mm and less than about 5 mm or 4 mm.

[0126] 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 entire length. The slits can be located on the short sidewall 1178 or the long sidewall 1180, or between the two, depending on the desired bending characteristics. The marker band can comprise any of a variety of radiopaque materials, such as a platinum / iridium alloy, and preferably has a wall thickness not exceeding about 0.003 inches, and in one embodiment about 0.001 inches.

[0127] When using multiple catheters, the perspective appearance of the marker band can be unique or different for each catheter size or type, so that the marker bands can be distinguished from each other by a software algorithm. When using multiple catheters together, such as in a multi-catheter assembly or stack as described herein, it may be advantageous to distinguish the marker bands of multiple catheters. In some embodiments, the marker band of the catheter can be configured to enable a software algorithm to detect movement of the catheter tip.

[0128] The marker band region of the assembled catheter can have a relatively high bending stiffness and a high crush strength, for example, at least about 50% less than the proximal segment 1158 or at least about 100% less, but typically no more than about 200% less than the proximal segment 1158. The high crush strength can provide radial support for the adjacent pusher segment 1154, and in particular for the anterior sidewall portion 1168, to facilitate the distal tip 1172 functioning as an atraumatic buffer during transluminal advancement and to prevent collapse under vacuum. The proximal segment 1158 preferably has a lower bending stiffness than the marker band region, and the pusher segment 1154 preferably has an even lower bending stiffness and crush strength than the proximal segment 1158.

[0129] The advancement section 1154 may include an outer tubular sheath 1164 and an optional distal extension of the inner liner 1160 without other internal support structures distal to the marker band 1156. The outer sheath 1164 may include an extruded polyurethane, such as Tecothane® or NEUsoft®. TM The advancement segment 1154 can have a bending stiffness and a radial crush stiffness that is no more than about 50%, and in some embodiments no more than about 25%, or 15%, or 5%, or less, of the corresponding values ​​of the proximal segment 1158.

[0130] The catheter can also include an axial tension element or support, such as a ribbon or one or more filaments or fibers, for increasing tension resistance and / or affecting bending properties in the distal region. The tension support can include one or more axially extending single or multiple filaments. One or more tension elements 1182 can be placed axially within the catheter wall near the distal end of the catheter. One or more tension elements 1182 can serve as tension supports and prevent the tip of the catheter wall from detaching or extending when under tension (for example, when the catheter is retracted proximally through a kinked outer catheter or a tortuous or narrowed vascular system).

[0131] 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 centimeters of the distal end of the catheter to less than about 10 centimeters of the distal end of the catheter, less than about 20 centimeters of the distal end of the catheter, less than about 30 centimeters of the distal end of the catheter, less than about 40 centimeters of the distal end of the catheter, or less than about 50 centimeters of the distal end of the catheter.

[0132] 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.

[0133] At least one of the one or more tension elements 1182 can extend at least about up to 50 centimeters of the length of the catheter, extend at least about up to 40 centimeters of the length of the catheter, extend at least about up to 30 centimeters or 20 centimeters or 10 centimeters of the length of the catheter.

[0134] In some embodiments, the tensile element extends along the length of the coil 24 from the distal end of the catheter to the proximal end and terminates proximally at a transition between the distal coil and the proximal braid about 5 cm or 2 cm or less on either side. The tensile element may terminate at the transition without overlapping the braid.

[0135] One or more tensioning elements 1182 can be placed adjacent to the liner layer 1160 or radially outside of the liner layer 1160. One or more tensioning elements 1182 can be placed adjacent to or radially inside of the braid and / or coil. One or more tensioning elements 1182 can be carried between the liner layer 1160 and the helical coil and can be secured to the liner layer or other underlying surface by an adhesive prior to adding the next outer adjacent layer (e.g., coil). Preferably, the tensioning elements 1182 are secured to the marker band 1156, for example, by an adhesive or by mechanical interference. In one embodiment, the tensioning element 1182 extends distally beyond the marker band on a first (e.g., inner) surface of the marker band, then wraps around the distal end of the marker band and extends along a second (e.g., outer) surface in one or both of a proximal oblique or circumferential direction to completely wrap around the marker band.

[0136] When more than one tensile element 1182 or filament bundle is circumferentially spaced apart in the catheter wall, the tensile elements 1182 can be placed in a radially symmetrical manner. For example, the angle between two tensile elements 1182 relative to the radial center of the catheter can be about 180 degrees. Alternatively, depending on the desired clinical performance (e.g., flexibility, trackability), the tensile elements 1182 can be placed in a radially asymmetric manner. The angle between any two tensile elements 1182 relative to the radial center of the catheter can be less than about 180 degrees, less than or equal to about 165 degrees, less than or equal to about 135 degrees, less than or equal to about 120 degrees, less than or equal to about 90 degrees, less than or equal to about 45 degrees, or less than or equal to about 15 degrees.

[0137] The one or more tensile elements 1182 may comprise materials such as Vectran®, Kevlar®, Polyester®, Spectra®, Dyneema®, Meta-Para-Aramide®, or any combination thereof. At least one of the one or more tensile elements 1182 may comprise a single fiber or a multi-fiber bundle, and the fibers or bundles may have a circular or rectangular (e.g., ribbon) cross-section. The terms fiber or filament do not convey composition, and they may comprise any of a variety of high tensile strength polymers, metals, or alloys, depending on design considerations such as the desired tensile failure limit and wall thickness. The cross-sectional dimension of the one or more tensile elements 1182 measured in the radial direction may not exceed approximately 2%, 5%, 8%, 15%, or 20% of the cross-sectional dimension of the catheter 10.

[0138] The cross-sectional dimension of one or more tension elements 1182 measured in the radial direction may be no more than about 0.03 mm (about 0.001 inch), no more than about 0.0508 mm (about 0.002 inch), no more than about 0.1 mm (about 0.004 inch), no more than about 0.15 mm (about 0.006 inch), no more than about 0.2 mm (about 0.008 inch), or about 0.38 mm (about 0.015 inch).

[0139] One or more tensioning elements 1182 can increase the tensile strength of the distal region of the catheter to at least about 1 pound, at least about 2 pounds, at least about 3 pounds, at least about 4 pounds, at least about 5 pounds, at least about 6 pounds, at least about 7 pounds, at least about 8 pounds, or at least about 10 pounds or more before failing under tension (e.g., the marker band detaches).

[0140] Depending on the desired data, any of a variety of sensors may be provided on any of the catheter, hub, pulley, or table. For example, in some embodiments, it may be desirable to measure, for example, axial tension or compression applied to the catheter along the force sensing region. The distal end of the catheter will be manufactured with, for example, Figure 11 , and has a helical coil distal portion. However, unlike a single helical coil using a nitinol wire, the first conductor 140 and the second conductor 142 are wound into helical coils that are wound around each other and are electrically insulated from each other, for example, by the plastic / resin of the tubular body. Figure 12A Each coil is in electrical communication with the proximal hub via a unique electrical conductor (eg, a conductive line of wire or a proximal extension).

[0141] This construction of two electrically isolated spiral coils creates a capacitor. This is roughly equivalent to two Nitinol plates with a plastic layer between them, such as Figure 12B As shown. The capacitance is inversely proportional to the distance between the filaments. The only variable that would change would be d, the distance between the plates. If an axial compressive force is applied to the catheter, the filaments (e.g., conductor 140 and conductor 142) will move closer together, thereby increasing the capacitance. If an axial tensile force is applied, the filaments will move further apart, decreasing the capacitance. This capacitance can be measured at the proximal end of the catheter, giving a measure of the force at the spiral capacitor. Although referred to as a capacitor, the sensor measures the electrical interaction between the two coils of wire. Due to the applied axial force, there may be a measurable change in inductance or other resulting change.

[0142] At least a first helical capacitor may have at least one, five, ten, or more complete rotations per filament. The capacitor may be located within 5 cm, 10 cm, or 20 cm of the distal-most end of the catheter body to sense the forces experienced at the distal end. At least a second capacitor may be provided within 5 cm, 10 cm, or 20 cm of the proximal-most end of the catheter body to sense the forces experienced at the proximal end of the catheter.

[0143] It may also be desirable to use the natural elasticity (compliance) of the magnetic connection to measure the elastic force across the magnetic connection between the hub and the corresponding pulley to measure the force applied to the hub. The magnetic connection between the hub and the pulley creates a spring. When a force is applied to the hub, the hub will move a small amount relative to the pulley. See Figure 13A In robotics, this is called a series elastic actuator. This property can be used to measure the force applied from the sled to the hub. To measure the force, the relative distance between the hub and the sled is determined ( Figure 13A dx) and characterizes some effective spring constant k between the two components. Figure 13B .

[0144] Relative distance can be measured in a variety of different ways. One method for measuring the relative distance between the hub and the pulley is a magnetic sensor (e.g., a Hall effect sensor between the hub and the pulley). A magnet is mounted to the hub or the pulley, and a corresponding magnetic sensor is mounted on the other device (the pulley or the hub). The magnetic sensor can be a Hall effect sensor, a magnetoresistive sensor, or another type of magnetic field sensor. Typically, multiple sensors can be used to increase the reliability of the measurement. This reduces noise and reduces interference from external magnetic fields.

[0145] Other non-contact distance sensors may also be used. These include optical sensors, inductive sensors, and capacitive sensors. The optical sensor will preferably be configured in a manner to avoid the accumulation of blood or other fluids in the interface between the hub and the pulley. In some embodiments, for example, a wireless (i.e., inductive) power supply may be used to convert movement and / or transmit information across the sterile barrier between the drive pulley and the hub.

[0146] The magnetic connection between the hub and the pulley has a shear or axial fracture threshold, which can be approximately 300 grams or 1000 grams or greater. The processor can be configured to compare the axial force applied to the catheter to a preset axial trigger force, which, if applied to the catheter, is perceived as creating a risk to the patient. If the trigger force is reached, the processor can be configured to generate a response to the physician (e.g., visual, auditory, or tactile feedback), and / or intervene and shut down further advancement of the catheter until repositioning is achieved. An override function can be provided so that the physician can choose to continue advancing the catheter at a force above the trigger force if the physician determines that an increase in force is justified.

[0147] Force and / or torque sensing optical fibers (e.g., Fiber Bragg Grating (FBG) sensors) can be built into the sidewall of the catheter to measure forces and / or torques at various locations along the axis of the catheter, or alternatively can be integrated into the guidewire. The fiber measures axial strain, which can be converted into axial force or torque (when helically wound). At least a first FBG sensor can be integrated into a distal sensing region, a proximal sensing region, and / or an intermediate sensing region on the catheter or guidewire to measure forces and / or torques near the sensor.

[0148] It may also be desirable to understand the three-dimensional configuration of a catheter or guidewire during and / or after transvascular placement. Shape sensing fibers, such as arrays of FBG fibers, are used to sense the shape of catheters and guidewires. By using multiple force sensing fibers at known distances from one another, the shape along the length of the catheter / guidewire can be determined.

[0149] Strain gauges can be integrated into the body of a catheter or guidewire to measure force or torque. In one example, the strain gauge is a resistive strain gauge. In some embodiments, the strain gauge is incorporated into the distal tip of the catheter, or incorporated into the proximal end of the catheter, and / or incorporated into the proximal end of the catheter and the proximal end of the catheter. In some embodiments, the strain gauge can be deposited on the wall of the catheter using thin film deposition techniques.

[0150] The measurement of the force and / or torque applied to the catheter or guidewire shaft can be used to determine the applied force and / or torque above a safety threshold. When the applied force and / or torque exceeds the safety threshold, a warning can be provided to the user. The applied force and / or torque measurement can also be used to provide feedback related to better catheter operation and control. The applied force and / or torque measurement can also be used together with processed fluoroscopic imaging information to determine or characterize distal tip motion.

[0151] The absolute position of the hub (and corresponding catheter) along the length of the table can be determined in a variety of ways. For example, a non-contact magnetic sensor can be configured to measure the position of the hub directly through a sterile barrier. The same type of sensor can also be configured to measure the position of the trolley. Each hub can have at least one magnet attached to it. The robotic table will have a linear array of corresponding magnetic sensors that pass through the entire length of the table. The processor can be configured to determine the position of the magnet along the length of the linear sensor array and display the axial position information to the physician.

[0152] Alternatively, the above purpose can be accomplished using a non-contact inductive sensor to directly measure the position of the hub through a sterile barrier. Each hub or trolley can be equipped with an inductive "target" therein. The robotic table can be equipped with an inductive sensing array over the entire working length of the table. As another option, an absolute linear encoder can be used to directly measure the linear position of the hub or trolley. The encoder can use any of a variety of different technologies, including optical, magnetic, inductive, and capacitive methods.

[0153] In one embodiment, 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) and is configured to detect an interrogator signal that stimulates a return signal from the passive tube coil. The PCB is configured to identify the return signal and its location.

[0154] The axial position of the sled can be determined using a multi-turn rotary encoder to measure the rotational position of the pulley, which is directly related to the linear position of the sled. Alternatively, direct measurement of the sled position can be accomplished by recording the number of steps a stepper motor is commanded to measure the rotational position of the pulley, which is directly related to the linear position of the sled.

[0155] The position of the catheter and guidewire within the anatomy may also be determined by processing the fluoroscopic images with machine vision, for example, to determine distal tip position, distal tip orientation, and / or guidewire shape. Comparing the distal tip position or movement, or lack thereof, with the 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 the like (e.g., along the length of the device shaft inside the body (e.g., in the aorta) or outside the body between the hubs). Processing can be performed in real time to provide position / orientation data at up to 30 Hz, although this technology can only provide data when fluoroscopic imaging is turned on. In some embodiments, machine vision algorithms can be used to generate and recommend optimal catheter maneuvers to approach or reach anatomical landmarks, similar to driver assistance. Machine vision algorithms can utilize the data to automatically drive the catheter based on the anatomy presented by fluoroscopy. Machine vision can also be used to analyze the straightness of the catheter relative to the tension generated. When tension is generated in the catheter due to navigating anatomical tortuosity, the catheter will begin to bend and flex in a sinusoidal manner, becoming less straight. If generated enough, this tension generation can lead to a more severe prolapse. Measurement of loss of straightness can be a signal to stop before prolapse occurs. This can be particularly useful when the prolapsed area is outside the current X-ray view.

[0156] A dual encoder torque sensor can be used to determine the proximal torque applied to a catheter or guidewire shaft. Figure 14 , the first encoder 144 and the second encoder 146 can be axially spaced apart along the shaft 148 to measure the angular difference over the length of the flexible catheter / tube. Since the catheter / tube has a known torsional stiffness, the angular difference is interpolated as the torque. When torque is applied to the shaft, the slightly flexible portion of the shaft will twist. The difference between the angles measured by the encoders (dθ) tells us the torque. T = k dθ, where k is the torsional stiffness.

[0157] Confirming the absence of bubbles in the fluid line can also be accomplished using a bubble sensor, particularly in situations where the physician is remote from the patient. This can be accomplished using a non-contact ultrasonic sensor that measures the intensity and Doppler shift of reflected ultrasound passing through the sidewalls of the fluid conduit to detect bubbles and measure fluid flow rate or fluid level. The ultrasonic or optical sensor can be located near the incoming fluid flow path within the hub, or in the supply line leading to the hub. To detect the presence of bubbles in an infusion line (formed of an ultrasonically or optically transmissive material), the sensor can include a signal source on a first side of the flow path and a receiver on a second side of the flow path to detect bubbles by measuring the transmission of liquid through the tube. Alternatively, due to the relatively high echogenicity of bubbles, the reflected ultrasonic signal can be detected from the same side of the flow path as the source.

[0158] Preferably, the bubble removal system is automatically activated when bubbles are detected in the line. The processor can be configured to activate a valve located in the flow path downstream of the bubble detector when bubbles are detected. The valve diverts a column of fluid from the flow path to the patient and into a reservoir. When bubbles are no longer detected in the flow path, and after the volume of fluid in the flow path between the detector and the valve has passed through the valve, the valve can be activated to reconnect the fluid source to the patient through the flow path. In some embodiments, bubbles can be dislodged from the catheter wall by beam ultrasonic energy from an ultrasonic transducer. In other embodiments, the bubble removal system can include a pump and control system upstream of the bubble detector for removing bubbles in the line. The processor can be configured to activate the pump when bubbles are detected to reverse the flow of fluid and purge the bubbles into a waste reservoir before bubble-free forward flow is reestablished.

[0159] Furthermore, it is desirable for the physician to be able to view the aspirated clot at a location within the sterile field, and preferably as close to the patient as possible for fluid management purposes. This can be accomplished by providing a clot retrieval device mounted on the hub, or by providing a clot retrieval device mounted in the aspiration line away from the hub in the direction of the pump. Figure 15One example of a clot retrieval device 370 may include a body 380 enclosing a chamber 381 in communication with the first port 310 and the second port 320 .

[0160] In some embodiments, the body 380 includes a housing having a top portion 382 and a bottom portion 384. The body 380 can include a filter 330 positioned between the top portion 382 and the bottom portion 384 in the chamber 381. In some examples, the first port 310 is configured to connect to a first end of a first tube 340 that is fluidly connected to a proximal end of the aspiration catheter.

[0161] In an embodiment configured for connection downstream from the hub, the first tube 340 includes a connector 342 at a second end of the first tube 340 that is configured to engage or mate with a corresponding connector on the hub or configured to engage or mate with a corresponding connector in communication with the hub. The first port 310 communicates directly with a chamber on the upstream (e.g., top side) of the filter, and the second port 320 communicates directly with a chamber on the downstream (e.g., bottom side) of the filter to facilitate direct visualization of material captured on the upstream side of the filter.

[0162] In embodiments configured for remote operation, any of a variety of sensors may be provided to detect clots passing through the aspiration line and / or trapped in the filter, such as optical sensors, pressure sensors, flow rate sensors, ultrasonic sensors, or other sensors known in the art.

[0163] In some embodiments, the second port 320 is configured to connect to a first end of a second tube 350, which is fluidly connected to a suction source (e.g., a pump). In some embodiments, the second tube 350 includes a connector 352 at a second end of the second tube 350 that is configured to engage or mate with a corresponding connector on the pump.

[0164] In some examples, the system 300 can include an on-off valve 360, such as a clamp 360. The clamp 360 can be located between the filter 330 and the patient, such as on the first tube 340, to allow the user to engage the clamp and provide flow control by isolating the patient from the clot retrieval device 370. Closing the valve 360 ​​and operating a remote vacuum pump (not shown) causes the canister associated with the vacuum pump and chamber 381 to reach the same low pressure. Due to the short distance and small linear volume of the lumen between the chamber 381 and the distal end of the catheter, a sharp negative pressure spike is quickly experienced at the distal end of the catheter after opening the valve 360. Additional details are disclosed in U.S. Patent No. 11,259,821, entitled "Aspiration System with Accelerated Response," issued to Buck et al. on March 1, 2022, the entire contents of which are hereby expressly incorporated herein by reference. In some embodiments, the vacuum can be circulated to the clot to recover the clot. The vacuum can be automatically and robotically controlled to remove the clot.

[0165] The body 380 can have a top surface separated from the bottom surface by a tubular sidewall. In the embodiment shown, the top and bottom surfaces are substantially circular and separated by a cylindrical sidewall. The top surface can have a diameter that is at least about three times, or five times or more, than the axial length of the sidewall (transverse to the top and bottom surfaces) to produce a generally disc-shaped housing. Preferably, at least a portion of the top wall is optically transparent to improve visualization of the clot after it is captured in the clot recovery 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.

[0166] In some examples, the body 380 can include a flush port (not shown) configured to allow an optically transparent medium, such as air, saline, or other fluid, to be injected into the chamber 381 to clear the optical path between the window and the filter, thereby improving visualization of the clot once it is trapped in the filter 330.

[0167] The foregoing represents certain specific embodiments of a drive stage and associated components and catheters. A wide variety of different drive stage configurations can be manufactured for supporting and axially advancing and retracting two, three, or four or more drive magnet assemblies to robotically drive interventional devices, fluidic elements, and electrical umbilical elements for transmitting electrical signals and fluids to a catheter hub, as will be understood by those skilled in the art in light of the disclosure herein. Additional details can be found in U.S. patent application Ser. No. 17 / 527,393, filed Nov. 16, 2021, the entire contents of which are hereby incorporated by reference herein.

[0168] Although the foregoing describes robotically driven interventional devices and manually driven interventional devices, the device can be manually driven, robotically driven, or a combination of manually and robotically driven interventional devices, as will be understood by those skilled in the art in view of the disclosure herein.

[0169] 16A to 16C An example control mechanism 2200 is shown for manipulating interventional devices driven by (or otherwise associated with) a respective hub. For example, each hub can be manipulated and / or otherwise moved using at least one control mounted in the control mechanism 2200. Each control can be adapted to move a unique hub-associated interventional device during an interventional procedure.

[0170] like Figure 16A As shown, the control mechanism 2200 includes a first control 2202, a second control 2204, a third control 2206, and a fourth control 2208. More or fewer controls may be provided depending on the desired interventional device configuration. Each control 2202 to 2208 is movably carried on a shaft 2210, which is connected to a distal support 2212 and a proximal support 2214. The controls 2202 to 2208 can be advanced distally or retracted proximally on the shaft 2210, as indicated by arrows 2218 and 2216. In addition, each control 2202 to 2208 can also rotate about the shaft 2210, as indicated by arrows 2220. Each control movement can trigger a corresponding movement in a corresponding pulley on the support table, which in turn can drive movement of the corresponding hub, as already discussed.

[0171] The control mechanism 2200 can be located on or near a patient support table having a set of hubs and catheter / interventional devices. In some embodiments, the control mechanism 2200 can be located remotely from the support table, such as behind a radiation shield or in a different room or geographical location in a telemedicine embodiment.

[0172] Each control member 2202 to 2208 can correspond to a hub and / or a combination of a hub and an interventional device and drive its movement. For example, the control member 2202 can be configured to drive the hub 30 ( Figure 3F ) to move an interventional device, such as a 0.088 inch guide catheter corresponding to hub 30. Similarly, control 2204 can be configured to drive hub 28 (122) to move an interventional device, such as a 0.071 inch surgical catheter. Control 2206 can be configured to drive hub 126 to move an interventional device, such as a steerable access catheter. Control 2208 can be configured to drive hub 26 to axially and rotationally move an interventional device, such as a guidewire.

[0173] Figure 16B An example of a manually manipulated control member 2202 on a control mechanism member 2200 is shown. In operation, if a user 2230 moves the control member 2202 axially and distally along the axis 2210, as indicated by arrow 2232, the corresponding connected hub and / or interventional device can responsively move in the same direction by the same or proportional amount. If the user 2230 rotates the control member 2202 about the axis 2210 and advances the control member proximally, as indicated by arrow 2234, the corresponding connected interventional device will correspondingly rotationally and proximally move by the same or proportional amount. If the user 2230 rotationally moves the control member 2202 about the axis 2210, as indicated by arrow 2236 or arrow 2238, the corresponding connected hub will rotationally drive the corresponding interventional device in the same direction and / or by the same or proportional amount.

[0174] Other axes and degrees of freedom can be defined to enable movement of the control member 2202 that can be translated into movement of the hub and / or interventional device. For example, the control member can be equipped with one or more deflection controls configured to activate lateral deflection in a deflection region on a corresponding interventional device.

[0175] Axial movement of the control can be configured to move the connected hub on a 1: 1 basis or on a non-1: 1 scaled basis. For example, if the user 2230 advances the control 2022 distally along the shaft 2210 by approximately 5 mm, the corresponding hub can correspondingly move 5 mm in the distal direction.

[0176] If the user 2230 rotates the control 2022 about its rotational axis by 5 degrees, the connected hub will rotate the corresponding interventional device on a 1: 1 basis or on a non-1: 1 scaled basis. The amount of scaling can be selected to reduce or increase the distance the hub and / or interventional device moves and the amount of rotation in response to control movement.

[0177] In some embodiments, a scaling factor can be used to determine the amount of scaling described herein. The scaling factor can be applied to one or both of translational and rotational movement. In some embodiments, a first scaling factor is selected for translational movement, and a second scaling factor, different from the first scaling factor, is selected for rotational movement. For a given proximal or distal operation of a control member, the axial scaling factor can drive proximal catheter movement at a faster rate than distal catheter movement.

[0178] The rotational scaling factor may be 1:1, while the axial scaling factor may cause the hub to move a greater distance than the control member, such that hub travel relative to control member travel is at least about 2:1 or 5:1 or 10:1 or greater, depending on the desired axial length of the control assembly.

[0179] The control mechanism 2200 can be configured to enable the clinician to adjust the scale factor for different parts of the procedure. For example, distal advancement of the surgical catheter and access catheter through the guide catheter and up to the selected port may be ideally accomplished in a "fast" mode. However, more distal advancement into the neurovascular system may be ideally accomplished in a relatively slow mode through speed-controlled actuation.

[0180] In another embodiment, one or more controls can be configured to gradually drive the advancement or retraction rate of the corresponding hub and associated catheter. For example, distal control 2202 can drive a guide catheter. Slight distal movement of control 2202 can advance the guide catheter distally at a slower rate, while advancing control 2202 distally over a greater distance increases the rate of distal travel of the guide catheter.

[0181] Controlling the speed of the corresponding hubs axially or axially and rotationally can increase the overall speed of the procedure. For example, advancement of various devices from a femoral access point to the aortic arch can be ideally accomplished at a faster rate than distal navigation closer to the treatment site. Furthermore, proximal retraction of various devices, particularly guidewires, access catheters, and surgical catheters, can be ideally accomplished at a relatively higher speed than distal advancement.

[0182] Figure 16C Another example of manually operating a control on a control mechanism member 2200 to move a hub and / or other interventional device is shown. In some embodiments, 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, user 2230 moves control 2204 and control 2206 in combination (e.g., sequentially, simultaneously) to simultaneously move a 0.088 guide catheter and a 0.071 aspiration catheter as an assembly. Example movement of control 2204 can include axial proximal movement in the direction indicated by arrow 2250. Sequentially or simultaneously, user 2230 can move control 2206 axially in either direction indicated by arrows 2254 and 2256, while also rotationally moving control 2206 in either direction indicated by arrows 2258 and 2260.

[0183] In some embodiments, each control member 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 embodiments, control color coding can also be applied to the hubs and / or interventional devices so that the user can visually match a specific hub / device with a specific control.

[0184] In some embodiments, controls 2202-2208 can be used to perform other control operations besides translational and rotational movement. For example, controls 2202-2208 can be configured to drive a shape change and / or a stiffness change of a corresponding interventional device. Controls 2202-2208 can be switched between different operating modes. For example, controls 2202-2208 can be switched between movement driven by acceleration and velocity and movement reflecting actual linear displacement or rotation.

[0185] In some embodiments, the control mechanism 2200 can be equipped with a visual display or other indicator of the relative position of the control members, which can correspond to the relative position of the interventional devices. Such a display can depict any or all movement directions, instructions, percentages of movement performed, and / or hub and / or catheter indicators to indicate which device is controlled by a particular control member. In some embodiments, the display can depict the applied force or resistance encountered by the catheter or other measurement detected or observed by a particular hub or interventional component.

[0186] In some embodiments, the control member 2200 can include a haptic component to provide tactile feedback to the user operating the control. For example, if the control 2202 triggers movement of the catheter and the catheter detects a large force at the tip, the control 2202 can generate tactile feedback to indicate to the user to stop or reverse the ongoing movement. In some embodiments, tactile feedback can be generated at the control to indicate to the user to slow down or speed up the movement using the control. In some embodiments, haptics can provide feedback on the accumulation of large torsional strains that may precede a sudden rotation, or can provide feedback on the accumulation of large axial forces that may be a prelude to catheter buckling.

[0187] The system described herein can compare the actual perspective image position with the input displacement from the controller. A static perspective image of the patient can be captured, in which the patient's vascular system is indicated relative to bone landmarks or one or more implanted soft tissue fiducial markers. The real-time perspective image can then be displayed as an overlay, aligned with the static image by registration of the fiducial markers. By visually observing the consistency of the real-time movement with the static image, assisted by the detected force data, it can help confirm the correct navigation of the associated catheter or guidewire. The system described herein can also display a comparison of the input proximal mechanical translation of the catheter or guidewire and the resulting output motion of the distal tip or its lack thereof. The loss of relative motion at the distal tip can indicate shaft buckling, prolapse, kinking, or similar results inside or outside the body. Such a comparison may be beneficial when shaft buckling, prolapse, kinking, or similar results appear outside the current perspective view.

[0188] Figure 17A schematic side elevation view of a multi-catheter interventional device assembly 2900 for combined supra-aortic access and / or neurovascular site access and surgery (eg, aspiration), as described herein, is shown. Multi-catheter assembly 2900 can be configured for manual or robotic surgery.

[0189] The interventional device assembly 2900 includes an insertion or access catheter 2902, a surgical catheter 2904, and a guide catheter 2906. Other components may include, but are not limited to, one or more guidewires (e.g., optional guidewire 2907), one or more guidewire catheters, an access sheath, and / or one or more other surgical catheters and / or associated catheter (control) hubs. In some embodiments, the assembly 2900 may also be configured with an optional deflection control 2908 for controlling the deflection of one or more catheters of the assembly 2900.

[0190] In operation, the multi-catheter assembly 2900 can be used without having to replace the hub assembly. For example, in the two-stage procedure previously disclosed, the first stage for achieving supra-aortic access includes installing the access catheter, guide catheter, and guidewire onto the support table. When supra-aortic access is achieved, the access catheter and guidewire are typically removed from the guide catheter. Then, after attaching a new guidewire hub and surgical catheter hub to the corresponding drive pulleys on the support table, the second catheter assembly is introduced over the guidewire catheter.

[0191] Figure 17 The single multi-catheter assembly 2900 is configured to operate without having to remove the hub and catheter and without adding additional components and / or hubs. Thus, the multi-component entry and surgical configuration of assembly 2900 can utilize a guidewire 2907 that is manufactured (configured) to serve as both an entry guidewire and a navigation guidewire to allow adequate access and support, as well as navigation to a specific 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., Figure 3A ), which is positioned on the drive platform and relative to Figure 17oriented to the right of catheter 2902), an insertion or entry catheter hub 2910, a surgical catheter hub 2912, a guide catheter hub 2914, and corresponding catheters. In certain embodiments, one or more of the hubs may include or be connected to a hemostatic valve (e.g., a rotary hemostatic valve) to accommodate the introduction of interventional devices therethrough, and / or the introduction of fluids (e.g., saline, contrast media). In certain embodiments, one or more of the hubs may include or be connected to a fluid system (which may include a hemostatic valve) for introducing fluids (e.g., saline, contrast media) and applying vacuum for aspiration functions. Other examples of hemostatic valves, fluid systems, and aspiration systems are included in U.S. patent application Ser. No. 17 / 879,614, filed on August 2, 2022, entitled “Multi Catheter System with Integrated Fluidics Management,” which is expressly incorporated herein by reference in its entirety.

[0192] Once access above the aortic arch is complete, the insertion or access catheter 2902 (associated with the insertion catheter hub 2910) can be "parked," for example, near the carotid ostium, and the remainder or subset of the catheter assembly can be directed more distally to a particular site (e.g., a clot site, a surgical site, a procedure site, etc.).

[0193] In some embodiments, other smaller surgical catheters may also be added and used at the site. In some embodiments, for catheter assembly 2900, in the robotic configuration of assembly 2900, catheter 2906 may be used as a guide catheter. Catheter 2904 may be used as a surgical (e.g., suction) catheter. In some embodiments, catheter 2906 may function as a suction in addition to serving as a guide catheter, instead of or in addition to catheter 2904. Access catheter 2902 may have a distal deflection region and may be used to access a desired port. One skilled in the art will appreciate the advantages of catheter 2906. Figures 20A to 20E It is understood that manual or robotic manipulation of multi-catheter stacks is contemplated herein.

[0194] In some embodiments, catheter assembly 2900 (or other combined catheter assembly as described herein) can be driven to a certain position as assembly. However, each catheter (or guidewire) assembly can be operated and driven to the same or different position independently of each other. Because each catheter will have its own stiffness distribution relative to length, the position and overlap of catheter can be adjusted to find corresponding optimal stiffness distribution, thereby helping to make the catheter stack navigate through various anatomical obstacles.

[0195] In a non-limiting example, the catheter assembly 2900 can be used for a diagnostic angiography procedure. In some embodiments, the assembly 2900 can include only a guidewire 2907 and an access catheter 2902 (in the form of a diagnostic angiography catheter) for performing a diagnostic angiography procedure, or only the guidewire 2907 and access catheter 2902 can be used during the procedure. Optionally, the guide catheter 2906 and the surgical catheter 2904 can be retracted proximally to expose the distal end of the access catheter 2902 (e.g., a few centimeters of the distal end of the access catheter) for performing a diagnostic angiography procedure.

[0196] like Figure 17 As shown, guide catheter 2906, surgical catheter 2904, access catheter 2902, and guidewire (or introducing element) 2907 may be arranged concentrically. Figure 52 A representation of a distal end view of a guide catheter 2906, a surgical catheter 2904, an access catheter 2902, and a guidewire 2907 is shown, showing a concentric arrangement. Figure 52As shown, the outer diameter 33 of guidewire 2907 is smaller than the inner diameter 35 of access catheter 2902, and the system is configured such that guidewire 2907 can be at least partially positioned within the lumen of access catheter 2902. The outer diameter of access catheter 2902 is smaller than the inner diameter 37 of surgical catheter 2904, and the system is configured such that access catheter 2902 can be at least partially positioned within the lumen of surgical catheter 2904. The outer diameter of surgical catheter 2904 is smaller than the inner diameter 39 of guide catheter 2906, and the system is configured such that surgical catheter 2904 can be at least partially positioned within the lumen of guide catheter 2906. In certain embodiments, guide catheter 2906 can be a "large bore" guide catheter or access catheter having a bore (inner) diameter 39 of at least about 0.075 inches 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 surgical catheter 2904 can be an aspiration catheter having an inner diameter 37 of about 0.060 to about 0.075 inches. The access catheter 2902 can be a steerable catheter with a deflectable distal tip having an inner diameter 35 of about 0.025 inches to about 0.050 inches. In some examples, the access catheter 2902 has an inner diameter 35 of about 0.045" to 0.049". When an appropriately sized guidewire 2907 is positioned in the access catheter, this configuration allows the effective cross-sectional area of ​​the lumen of the access catheter to be used for fluid communication, as further described herein. In some examples, the appropriately sized guidewire 2907 has an outer diameter 35 of about 0.014 to about 0.020 inches (0.020"). In some examples, 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" + / - 0.0005". However, a smaller diameter guidewire (e.g., 0.014"-0.020") is preferred to provide the desired effective cross-sectional area of ​​the entry catheter for fluid injection when the guidewire is at least partially located within the entry catheter lumen. In one example of a system configuration in which the system can infuse a contrast agent (or another fluid) into a patient through access catheter 2902 while guidewire 2907 is partially or fully positioned within the lumen of access catheter 2902, guidewire 2906 can have an inner diameter 39 of approximately 0.088 inches, surgical catheter 2904 can have an inner diameter 37 of approximately 0.071 inches, access catheter 2902 can have an inner diameter 35 of approximately 0.035 inches to 0.048 inches, and guidewire 2907 can have an outer diameter 33 of approximately 0.018 inches. In one example, guide catheter 2906 can have an outer diameter of approximately 0.110 inches, surgical catheter 2904 can have an outer diameter of approximately 0.083 inches, and access catheter 2902 can have an outer diameter of approximately 0.061 inches.

[0197] In some embodiments, the access catheter 2902 can have an inner diameter 35 of approximately 0.046 inches to 0.047 inches, and the guidewire 2907 can have an outer diameter 33 less than or equal to 0.024 inches, such as an outer diameter 33 of approximately 0.014 inches to approximately 0.024 inches. These configurations provide sufficient annular space within the lumen of the access catheter 2902 to allow contrast media to propagate through the lumen of the access catheter 2902, so that the guidewire 2907 can remain in place while the contrast media is injected into the catheter assembly 2900. This advantageously reduces the overall procedure time by eliminating the need to remove the guidewire 2907 each time contrast media is injected (to create sufficient annular space within the lumen of the access catheter 2902 to allow contrast media to flow through the lumen of the access catheter 2902). For example, these configurations allow contrast media to flow within the catheter at a flow rate of approximately 3 cc's per second at a pressure of no more than 400 psi. In some examples, the length of such a catheter is approximately 100 cm to 160 cm. Additionally, such a configuration reduces the risk of air embolism associated with repeated removal and reinsertion of the guidewire 2907 from the catheter assembly 2900.

[0198] As further described with reference to the embodiments / tests, in order to provide the desired fluid flow through the entry conduit 2902 when the guide element 2907 is located within the entry conduit 2902, a certain effective cross-sectional area 41 of the entry conduit 2902 should be available to communicate fluid from the proximal end of the conduit to the distal end and out of the entry conduit. Figure 52The effective cross-sectional area 41 of the access catheter 2902 (i.e., the space in the lumen of the access catheter 2902 through which fluid can be communicated when the guide element 2970 is located therein) is determined by subtracting the cross-sectional area 43 of the guide element 2907 from the cross-sectional area of ​​the access catheter 2902. Through testing associated with this unique configuration providing fluid communication through the access catheter (with the guide element located therein) at the described operating pressures (e.g., less than about 400 psi), it was determined that an effective cross-sectional area 41 of at least about 0.001257 square inches is desirable. In one example, an effective cross-sectional area 41 of at least 0.001407 square inches is desirable to produce the desired contrast fluid flow at less than about 400 psi. An effective cross-sectional area of ​​at least about 0.001257 square inches can be achieved using various sizes of the outer diameter 33 of the guide element 2907 and the inner diameter 35 of the entry conduit 2902, as shown in the following table, which shows examples of determined effective cross-sectional areas for entry conduits of various entry conduit inner diameter sizes and various guide element (GE) outer diameter sizes, where shaded cells indicate effective cross-sectional areas that fall below the threshold of 0.001257 square inches. In one example, as shown in the table, an entry conduit ID of 0.045 inches and a guide element OD of 0.020 inches provide an effective cross-sectional area of ​​the entry conduit of 0.001276 square inches, which is acceptable (unshaded) because it is above the threshold of 0.001257 square inches. In another example, as shown in the table, an entry conduit ID of 0.045 inches and a guide element OD of 0.021 inches provide an effective cross-sectional area of ​​the entry conduit of 0.001244 square inches, which is unacceptable (shaded) because it is below the (predetermined) threshold of 0.001257 square inches. Although the table below shows some examples, other example configurations that meet the threshold are possible.

[0199] Effective cross-sectional area of ​​the entry duct

[0200] In some embodiments, the length of the access catheter 2902 can be 100 cm to 193 cm. In certain embodiments, the wall of the access catheter 2902 surrounding the lumen can include a braided reinforcement layer and an internal lining (e.g., PEBAX). The braided reinforcement layer can include stainless metal ribbon wires in a tightly woven pattern. In one example, the metal ribbon wires can have a cross-sectional dimension of approximately 0.002" x approximately 0.005". In other embodiments, the braided reinforcement layer can include stainless metal round wires with a diameter of 0.002 inches in a tightly woven pattern (e.g., a 1:1 braid pattern or a 2:2 braid pattern). In various examples, the ribbon material can be made of stainless steel or other materials (including titanium, CoCr alloy, Elgiloy, Hasteloy (Hastelloy alloy) and the like), or include stainless steel or other materials (including titanium, CoCr alloy, Elgiloy, Hasteloy (Hastelloy alloy) and the like).

[0201] The guide catheter 2906 and the access catheter 2902 can each have a proximal end 1810 and a distal end 1812. In some embodiments, the distal end 1812 of the guide catheter 2906 and the access catheter 2902 can each have a hypotube tip 1806 and 1802, respectively, such as Figure 18 As shown. In some examples, the tip may include nitinol. In an example, the catheter tip may include a laser-cut hypotube composed of nitinol, which is bonded to another proximal laser-cut hypotube composed of stainless steel. Due to the enhanced rigid material properties of stainless steel, this advantageously allows for better pushability and twistability. The flexibility of the metal hypotube can be achieved by a cut pattern in its wall. In an example, an interrupted spiral pattern can achieve this. In another example, multiple cuts (e.g., a pattern of cuts or holes) can be used to achieve the desired stiffness / flexibility of the catheter tip. The length of the cut and the spacing between the cuts can help define the stiffness of the catheter. One or more lasers can be used to make the cuts. In some embodiments, the hypotube tips are the same diameter (e.g., the outer diameter of the hypotube tip is the same diameter as the catheter portion adjacent to the hypotube tip). In some embodiments, the diameter of the hypotube tip is smaller than the diameter of the portion of the catheter adjacent to the tip (e.g., the outer diameter of the hypotube tip is smaller than the outer diameter of the portion of the catheter adjacent 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 that enables better pushability and torque control, as well as reduced susceptibility to buckling.

[0202] Figure 19A cross-sectional view of a laser cut hypotube 1902 is shown. In some embodiments, the laser cut hypotube can be comprised of a metal (e.g., nitinol, stainless steel, etc.) stent 1906 defining a plurality of holes 1904. In some embodiments, the distal end of the access catheter 2902 can include a laser cut hypotube 1902 for enhancing heat setting properties to allow the access catheter to be properly shaped to navigate the patient's vasculature. In some embodiments, the use of a nitinol hypotube allows the catheter to be folded back or bent when packaged. This is advantageous because the catheter may be too long to be packaged directly. The superelastic properties of nitinol also allow the catheter to be twisted without the catheter whipping.

[0203] Although the embodiments disclosed herein are described with respect to the injection of contrast agents, those skilled in the art will appreciate that these concepts can be applied to any fluid (e.g., saline, medication, etc.) injected into the catheter assembly 2900. The viscosity of the liquid injected into the catheter assembly 2900 may affect the annular space required in the lumen of the entry catheter 2902 to allow for sufficient flow rate. Therefore, depending on the viscosity of the liquid injected into the catheter assembly 2900, an entry catheter 2902 having a diameter and / or length different from that described above may be required. Similarly, depending on the properties of the liquid being injected into the catheter system, guidewires of different diameters or having different properties (e.g., having a hydrophilic coating) may be required to promote the desired flow characteristics. In some embodiments, a guide element (e.g., a guidewire) may include different surface properties at its proximal and distal ends. In an example, the guide element may include a hydrophilic coating on its distal end and a hydrophobic coating on its proximal end. In an example, the hydrophobic coating is polytetrafluoroethylene (PTFE). In an example, the hydrophobic coating comprises a PTFE-based composition. In an example, the PTFE-based composition is Teflon. TM The examples described in detail at the end of this disclosure illustrate different configurations of some embodiments of catheter assembly 2900 that may be used.

[0204] Figures 20A to 20E Depicted is an exemplary sequence of steps for introducing a multi-catheter assembly configured to manually or robotically achieve direct access to a clot. Figures 20A to 20E Can be used Figure 17 Other combinations of catheters may be substituted for the interventional device assembly, as will be understood by those skilled in the art in light of the disclosure herein.

[0205] refer to Figure 20A, the three-catheter interventional device assembly 2900 is shown as being driven through the introducer sheath 3002, up through the iliac arteries 3004 and into the descending aorta. Next, the access catheter 2902, the surgical catheter 2904 (e.g., 0.071 inches), and the guide catheter 2906 (e.g., 0.088 inches) are tracked to the aortic arch 3006, as shown. Figure 20B Here, the distal end of the guide catheter 2906 can be parked below the aortic arch 3006, and the surgical catheter 2904, the access catheter 2902 (located within the surgical catheter 2904, and Figure 20B ostium (not visible in the figure) and guidewire 2907 can be driven into the ostium (e.g., simultaneously or separately). In some embodiments, the access catheter 2902 is pushed out of the surgical catheter 2904 and the guide catheter 2906 to first engage the ostium. After the distal end of the access catheter 2902 is positioned within the desired ostium, the guidewire 2907 can be advanced distally into the ostium to secure (or guide) access, and / or to confirm correct vessel selection and positioning. After the access catheter 2902 and guidewire 2907 are positioned within the desired ostium, the surgical catheter 2904 and / or guidewire 2906 can be advanced into the ostium (and in some embodiments, beyond the ostium) while using the support of the access catheter 2902 and / or guidewire 2907 to maneuver through the aorta and into the ostium. Figure 20B In the embodiment shown, the surgical catheter 2904 has been advanced into the ostium, while the guide catheter 2906 has been maintained below the aortic arch 3006.

[0206] refer to Figure 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 artery 3014. The guidewire 2907 is then advanced superiorly to the petrous segment 3018 of the internal carotid artery 3016.

[0207] refer to Figure 20D , guide catheter 2906 and surgical catheter 2904 (located within guide catheter 2906 and Figure 20D (not visible in FIG) over the guidewire 2907 and into the catheter 2902 (located within the surgical catheter 2904 and Figure 20D The guidewire 2907 can be further advanced through the rock segment 3018 to the site of the clot 3020, such as the M1 segment.

[0208] refer to Figure 20E , guide catheter 2906 and surgical catheter 2904 (located within guide catheter 2906 and Figure 20D3020) are advanced (e.g., simultaneously or sequentially) to position the distal tip of surgical catheter 2904 at the surgical site, such as on the surface of clot 3020. Guidewire 2907 and access catheter 2902 (located within surgical catheter 2904 and Figure 20E 2906) and aspiration of the clot 3020 is initiated through the surgical catheter 2904. That is, the guidewire 2907 and the access catheter 2902 are retracted proximally to allow aspiration through the surgical catheter 2904. After aspiration of the clot, the surgical catheter 2904 and the guide catheter 2906 can be removed (e.g., simultaneously or sequentially). For example, in some embodiments, the surgical catheter 2904 can be removed before the guide catheter 2906 is removed.

[0209] The catheter assembly 2900 can be used to perform neurovascular procedures, such as Figures 20A to 20E As shown. For example, the neurovascular procedure can be a neurovascular thrombectomy. The steps of the procedure can include providing an assembly comprising at least a guidewire, an access catheter, a guide catheter, and a surgical catheter. For example, catheter assembly 2900 includes a guidewire 2907, an access catheter 2902, a guide catheter 2906, and at least one surgical catheter 2904. The surgical catheter 2904 can include an aspiration catheter, an embolization deployment catheter, a stent deployment catheter, a shunt deployment catheter, a diagnostic angiography catheter, a stent retrieval catheter, a clot retrieval catheter, a balloon catheter, a catheter for facilitating percutaneous valve repair or replacement, an ablation catheter, and / or an RF ablation catheter or guidewire.

[0210] The neurovascular procedure may also include the steps of connecting the assembly to a non-robotic or robotic drive system and driving the assembly to achieve supra-aortic access. The steps may also include driving a subset of the assembly to the neurovascular site and performing the neurovascular procedure using the subset of the assembly. The subset of the assembly may include a guidewire, a guide catheter, and a surgical catheter.

[0211] Each of the guidewire 2907, access catheter 2902, surgical catheter 2904, and guide catheter 2906 is configured to be regulated by a corresponding hub. For example, the guidewire 2907 may include (or be connected to) a hub (e.g., hub 26, Figure 3A ). Similarly, access catheter 2902 may include or be connected to catheter hub 2910. Surgical catheter 2904 may include or be connected to surgical catheter hub 2912. Guide catheter 2906 may include or be connected to guide catheter hub 2914.

[0212] Generally, the connections of assembly 2900 can include magnetically connecting a first hub 2909 connected to a guidewire 2907 to a first drive magnet; magnetically connecting a second hub 2910 connected to an access catheter 2902 to a second drive magnet; magnetically connecting a third hub 2912 connected to a surgical catheter 2904 to a third drive magnet; and magnetically connecting a fourth hub 2914 connected to a guide catheter 2906 to a fourth drive magnet. In various embodiments, a layer or layers of material (i.e., one or more layers of material) can be provided between each of the first, second, third, and fourth hubs and their corresponding first, second, third, and fourth drive magnets, allowing for magnetic connection through the material layers. In various embodiments, each layer can be flexible, semi-rigid, or rigid. A layer can be a sterile barrier. When the system is configured for use, the first, second, third, and fourth drive magnets can each be independently movable and movably carried by (or on) a drive station, e.g., as described with respect to the tray assembly and controls described herein. In some embodiments, the first drive magnet, the second drive magnet, the third drive magnet and the fourth drive magnet are connected to their respective catheter hubs by 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 into a drive platform having a plurality of drive magnets that are controlled to move along the drive platform (e.g., along the longitudinal axis of the drive platform). In some embodiments, two or more drive magnets can be bolted together or otherwise connected together to move as a combination in response to a command from a single controller. In some examples, the drive magnets can be connected together to move together (e.g., physically connected together or configured to move together by a controller). In an example, the first and second drive magnets can be configured to move together along the drive platform. 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 accordingly, the hubs to which the first, second, third, and fourth drive magnets are connected) can be configured to move together along the drive stage.

[0213] In some embodiments, the step of performing the 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 achieve supra-aortic vascular access. The hub adapter can include, for example, a connector / pulley that acts as a shuttle by being propelled proximally or distally along a track in response to operator commands. The hub adapters described herein can each include at least one drive magnet configured to connect to a magnet carried by a corresponding hub (sometimes referred to herein as a "driven magnet"). This provides a magnetic connection between the drive magnet and the driven magnet through a sterile barrier, such that the corresponding hub is responsive to a hub adapter positioned outside the sterile field (e.g., Figure 4 The hub adapter is moved into the top of the sterile barrier (within the sterile field) by movement of the guidewire hub 2909, access catheter hub 2910, surgical catheter hub 2912, and guide catheter hub 2914.

[0214] Movement of the catheter assembly 2900 during a procedure can include moving a portion of the catheter assembly 2900. For example, moving the catheter assembly 2900 during a procedure can include driving a subset of the assembly in response to movement of one or more of the hub adapters along the support platform until the subset of the assembly is positioned for performing a neurovascular procedure at a neurovascular treatment site. The subset of the assembly can include a guidewire 2907, a guide catheter 2906, and / or a surgical catheter 2904.

[0215] In some embodiments, the guidewire 2907, guide catheter 2906, and surgical catheter 2904 are passed as an assembly (relative to the guidewire 2907) and over (relative to the guide catheter 2906 and surgical catheter 2904) at least a portion of the length of the entry (e.g., insertion) catheter 2902 after access over the aorta is achieved.

[0216] In some embodiments, catheter assembly 2900 can be part of a robotically controlled system for achieving supra-aortic access and neurovascular treatment site access, such as Figures 20A to 20EAs shown. 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 (having manual and robotic components) for achieving supra-aortic access and neurovascular treatment site access. For example, in such a hybrid system, supra-aortic access can be robotically driven, while neurovascular site access and embolectomy or other procedures can be manual. Alternatively, in such a hybrid system, supra-aortic access can be manual, while neurovascular site access can be robotically achieved. In addition, in such a hybrid system, any one or more of the guidewire, access catheter, guide catheter, or surgical catheter can be robotically driven or manually operated.

[0217] The example robotic control system can include at least a guidewire hub (e.g., guidewire hub 2909) configured to adjust each of the axial position and the rotational position of the guidewire 2907. The robotic control system can also include an access catheter hub 2910 configured to adjust the axial and rotational movement of the access catheter 2902. The robotic control system can also include a guide catheter hub 2914 configured to control the axial movement of the guide catheter 2906. The robotic control system can also include a surgical catheter hub 2912 configured to adjust the axial position and the rotational position of the surgical catheter 2904.

[0218] In some embodiments, the surgical catheter hub 2912 is further configured to laterally deflect the surgical catheter 2904 via a distal deflection region.

[0219] In some embodiments, the guidewire hub 2909 is configured to connect to the guidewire hub adapter by magnetically connecting the guidewire hub to the first drive magnet. The access catheter hub 2910 is configured to connect to the access catheter hub adapter by magnetically connecting the access catheter hub 2910 to the second drive magnet. The surgical catheter hub 2912 is configured to connect to the surgical catheter hub adapter by magnetically connecting the surgical catheter hub 2912 to the third drive magnet. The guide catheter hub 2914 is configured to connect to the guide catheter hub adapter by magnetically connecting the guide catheter hub 2914 to the fourth drive magnet. In some embodiments, the first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet are independently and movably carried by the drive platform.

[0220] In some embodiments, the robotic control system includes a first driven magnet on the guidewire hub 2909. The first driven magnet can be configured to cooperate with the first drive magnet such that the first driven magnet is configured to move in response to movement of the first drive magnet. In some embodiments, the first drive magnet is configured to move through a barrier to the outside of the sterile field separated from the first driven magnet while the first driven magnet is within the sterile field. In some embodiments, the position of the first driven magnet can move in response to operation of a surgical drive control on a console associated with the drive table. Figure 4 The interaction between the driving magnet and the driven magnet is described in detail in .

[0221] In some embodiments, the robotic control system includes a second driven magnet on the entry catheter hub 2910. The second driven magnet can be configured to cooperate with the second drive magnet 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 through a barrier when the second driven magnet is within the sterile field.

[0222] In some embodiments, the robotic control system includes a third driven magnet on the surgical catheter hub 2912. The third driven magnet can be configured to cooperate with the third drive magnet 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 through a barrier when the third driven magnet is within the sterile field.

[0223] In some embodiments, the robotic control system includes a fourth driven magnet on the guide catheter hub 2914. The fourth driven magnet can be configured to cooperate with the fourth drive magnet so that the fourth driven magnet is configured to move in response to the movement of the fourth drive magnet. In some embodiments, the fourth drive magnet is configured to move through a barrier to the outside of the sterile area separated from the fourth driven magnet when the fourth driven magnet is within the sterile area. In some embodiments, there can be more than four driven magnets and corresponding catheter hubs for controlling additional catheters.

[0224] In some embodiments, the devices described herein (e.g., hubs, hub adapters, interventional devices, and / or trays) can be used in robotically driven surgery. For example, in robotically driven surgery, one or more interventional devices can be driven through the vascular system and reach the surgical site. Robotically driving such a device can include engaging an electromechanical assembly controlled by user input. In some embodiments, a user can provide input at a control system that interfaces with one or more hubs and hub adapters.

[0225] In some embodiments, the hubs, hub adapters, interventional devices, and trays described herein can be used during non-robotic (e.g., manually driven) surgery. Manually driving such a device can include manually engaging the hub to affect movement of the interventional device.

[0226] In some embodiments, the devices described herein can be used to implement methods for performing intracranial surgery at an intracranial site. The methods for performing intracranial surgery can include any of the same steps as those described herein for performing neurovascular surgery. The methods can be performed robotically, manually, or a hybrid combination of the two.

[0227] While the foregoing describes a magnetic connection of the hub to the drive magnet, in other embodiments, any interventional device and / or hub can be mechanically connected to the drive system. Any method described herein may include the step of mechanically connecting one or more interventional devices (e.g., guidewire 2907, access catheter 2902, surgical catheter 2904, and / or guide catheter 2906) and / or one or more hubs (e.g., guidewire hub 2909, access catheter hub 2910, surgical catheter hub 2912, and / or guide catheter hub 2914) to one or more drive mechanism components.

[0228] Figure 21 An embodiment of a mechanical connection mechanism 1654 between a driver mechanism 1650 and a driven mechanism member 1652 is shown. The driver mechanism 1650 and the driven mechanism member 1652 can have any features or functions that are identical or similar to the drive magnet 67 and the driven magnet 69, respectively, unless otherwise described herein. The driver mechanism 1650 can be a part of or connected to a hub adapter (e.g., hub adapter 48). The driven mechanism member 1652 can be a part of or connected to a hub (e.g., hub 36, guidewire hub 2909, entry catheter hub 2910, surgical catheter hub 2912, or guide catheter hub 2914). In some cases, the mechanical connection mechanism 1654 can include a structural support member (e.g., a support rod or support strut) that extends laterally through the seal in the sterile barrier 1632. As the driver member 1650 and the follower member 1652 are advanced and / or retracted as described herein, the seal can allow the structural support to be advanced along the length of the sterile barrier 1632 while still maintaining a seal with the structural support to maintain the sterile field. For example, the seal can include a tongue and groove closure mechanism along the sterile barrier 1632 that is configured to close on either side of the structural support while allowing the structural support to pass through the sterile barrier 1632 and maintain the seal against the structural support as the structural support is advanced along the length of the sterile barrier 1632.

[0229] In some embodiments, the structural support can extend through an elongated self-closing seal (e.g., shaped like a duckbill valve) between two adjacent mating edges of a flexible material that extends along the shaft. As the structural support is advanced along the shaft between the mating edges, the mating edges can allow the structural support to advance and then be biased back into sealing engagement with each other when the structural support passes any given point along the shaft.

[0230] In some embodiments, the drive mechanism component can be a spline drive shaft (e.g., a non-sterile spline drive shaft). Mechanical connection 1654 can include a pulley in the plate used as sterile barrier 1632 and a sterile spline shaft configured to be connected to a driven member 1652. Driven member 1652 can be a sterile pulley that receives a sterile spline shaft from a sterile barrier. In some embodiments, one or more spline drive shafts can engage and rotate the corresponding pulleys used as sterile barrier in the plate. Each hub can have a sterile pulley that is configured to receive a sterile spline shaft from a sterile barrier plate. The rotation of the spline drive shaft can rotate the pulley in the sterile barrier plate, which can rotate the sterile pulley in the hub via a sterile spline shaft.

[0231] Those skilled in the art will appreciate that any of the embodiments described herein may be modified to incorporate mechanical connectors, such as Figure 21 shown.

[0232] The interventional devices described herein can be provided separately, or at least some of the interventional devices can be provided in a preassembled (e.g., nested or stacked) configuration, for example, as part of a sterile kit. In an example, the interventional device can be provided in a concentric nested or stacked configuration in the form of an interventional device assembly (e.g., interventional device assembly 2900). If provided separately, each catheter (and in some embodiments, each corresponding catheter hub) can be unpacked and pre-filled to remove air from its inner lumen, for example, by flushing the catheter (and in some embodiments, flushing each corresponding catheter hub) to remove air by replacing the air with a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent). After pre-filling, the interventional devices can be manually assembled into a stacked configuration so that they are ready to be introduced into the body for surgical operation, for example, via an introducer sheath.

[0233] Assembling the devices into a stacked configuration may include inserting the interventional devices individually into each other in order of size. For example, an interventional device having the second largest diameter may be inserted into the lumen of an interventional device having the largest diameter. An interventional device having the third largest diameter may then be inserted into the lumen of an interventional device having the second largest diameter, and so on.

[0234] For example, by Figure 17, can be assembled by first inserting the distal end of catheter 2904 through hub 2914 and into catheter 2906. Catheter 2904 can be advanced through catheter 2906 until the distal tip of catheter 2904 is flush with or extends beyond the distal tip of catheter 2906, and / or until catheter 2904 can no longer be inserted. Then, the distal end of catheter 2902 can be inserted through hub 2912 and into catheter 2904. Catheter 2902 can be advanced through catheter 2904 until the distal tip of catheter 2902 is flush with or extends beyond the distal tip of catheter 2904, and / or until catheter 2902 can no longer be inserted. Then, the distal end of guidewire 2907 can be inserted through hub 2910 and into catheter 2902. The guidewire 2907 may be advanced through the catheter 2902 until the distal tip of the guidewire 2907 is flush with or extends beyond the distal tip of the catheter 2902 and / or until the guidewire 2907 cannot be inserted any further.

[0235] Embodiments in which two or more interventional devices are packaged together as a single assembly in an assembled (e.g., nested or stacked) configuration can provide efficient unpacking and preparation prior to use, and provide efficient assembly within a robotic control system. The interventional devices can be pre-installed to their respective hubs prior to packaging. In certain embodiments, two or three or more interventional devices can be packaged in a fully nested (i.e., fully axially inserted) configuration or an almost fully nested configuration. In a fully nested configuration, each interventional device is inserted as far as possible into 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.

[0236] In some embodiments, interventional device can also be sterilized before packaging, while in assembly configuration, for example, using ethylene oxide gas.In some embodiments, before sterilizing with ethylene oxide gas, interventional device can be packaged in assembly configuration.For the interventional device of nested or stacked configuration, ethylene oxide gas can be provided in the space (for example, the annular lumen between the outer diameter of the first interventional device and the inner diameter of the second interventional device nested in the second interventional device) between adjacent interventional devices for sterilization.In some embodiments, interventional device assembly can be packaged in a thermoformed tray and sealed with HDPE (for example, Tyvek®) lid. The interventional device assembly can be unpacked by removing (for example, opening or peeling off) lid by the user in a sterile area. Then, the user in the sterile area can remove the interventional device assembly and place it on the sterile working surface of, for example, a robot-driven table, as described herein.

[0237] Packaging the interventional devices in an assembled configuration and sterilized state can reduce the time associated with unpacking and assembly of individual interventional devices and facilitate efficient connection to a robotic drive system. Each interventional device and hub combination can also be packaged with a fluidic connector for connecting to a fluid source or one or more fluid sources and / or a vacuum source. In some embodiments, each hub or hemostatic valve connected to the hub can include a fluidic connector.

[0238] After unpacking the interventional device assembly (e.g., after positioning the interventional device assembly on the robotic drive station), pre-filling can be performed while the devices are concentrically nested or stacked. This is preferably done in each catheter lumen, for example, in the annular lumen between the guide catheter 2906 and the surgical catheter 2904, and between each additional concentric interventional device in the catheter stack. In certain embodiments, fluid can be introduced in one or more lumens of the catheter stack to pre-fill one or more interventional devices. For example, fluid can be introduced in the lumen between the distal hub and the proximal interventional device. For example, in the lumen between the hub 2914 and the catheter 2904. In certain embodiments, pre-filling can be performed when the device is in sterile packaging. More generally, pre-filling of one or more catheters in the catheter stack can be performed when the catheter assembly has been removed from its packaging.

[0239] The fluidics connector of catheter assembly (for example, the fluidics connector of one or more hubs) can be connected to fluid system, for saline and contrast agent are delivered to catheter and suction is provided.In some embodiments, one or more (for example, saline, contrast agent or the mixture of saline and contrast agent) in the fluidics connector can extend to the outside of sterile area from sterile area, for being connected to fluid system.After being connected, fluid system can carry out a series of pre-fills to rinse each catheter of interventional device assembly with fluid (for example, saline, contrast agent, or the mixture of saline and contrast agent).A series of pre-fills can also comprise flushing each corresponding catheter hub with fluid.Fluid can be by fluid system before pre-filling except air or degassing.In some embodiments, the vacuum source of fluid system can also be used for evacuating air from each catheter when flushing with fluid.In certain embodiments, the tip of catheter can be placed in the container of fluid (for example saline, contrast agent, or the mixture of saline and contrast agent) during pre-filling, so that when applying vacuum source, the fluid in the container rather than the tip of air is aspirated by catheter. In other embodiments, the tip of the catheter can be closed (e.g., using a plug) so that air is not drawn from the tip of the catheter when a vacuum source is applied. In certain embodiments, the priming process can be automated so that a user can provide a single command, and each catheter (and in some embodiments, each corresponding catheter hub) can be primed sequentially or simultaneously (e.g., as by Figures 22A to 22C described).

[0240] Additional details regarding the fluid system are described in U.S. patent application Ser. No. 17 / 879,614, filed on August 2, 2022, entitled “Multi Catheter System With Integrated Fluidics Management,” which is attached hereto (Appendix A) and is hereby expressly incorporated herein in its entirety.

[0241] When the cross-sectional lumen area available for flow is reduced, for example, when a second interventional device (e.g., a catheter or guidewire) is extended within the lumen of a first interventional device, the fluid resistance within the lumen can be greater. For example, the amount of fluid resistance can be affected by the length narrowing of the cross section due to the depth of axial insertion of the second interventional device within the first interventional device. A second interventional device that extends partially through the lumen of the first interventional device will provide a smaller length narrowing of the cross section and, therefore, may result in a lower fluid resistance within the lumen of the first catheter than would be the case if the second interventional device were fully extended through the lumen of the first interventional device. Thus, fluid resistance can be reduced by at least partially reducing the depth to which the second interventional device is axially inserted (i.e., axially overlapped) into a lumen through which fluid is injected (e.g., the length of the second interventional device into its concentrically adjacent lumen).

[0242] In some embodiments, at certain insertion depths of the second interventional device within the first interventional device (e.g., when the second interventional device is at or near a maximum insertion depth within the first interventional device), the size of the fluid pathway between the devices (e.g., the annular lumen between the first interventional device and the second interventional device) can result in a higher than desired amount of fluid resistance during the priming process. In some embodiments, the insertion depth of the second interventional device within the first interventional device can be reduced to reduce the pressure required to prime the catheter and reduce internal interference.

[0243] In some embodiments, the catheter in the interventional device assembly can be separated from other interventional devices, for pre-filling, to reduce the pressure required for pre-filling catheter and to reduce internal interference. By making the interventional device retract to the proximal end in the lumen of catheter, the catheter to be pre-filled can be separated from the interventional device in the lumen of catheter. For example, the interventional device in the lumen of catheter to be pre-filled can be retracted to the proximal end as far as possible from the catheter to be pre-filled, while still keeping nested or stacked relationship (for example, at least about 2 cm or 5 cm or more axial overlap), so as to minimize the pressure required for pre-filling catheter and minimize internal interference. In other words, catheter can be separated from the interventional device of more proximal end, for pre-filling, and the distal tip of adjacent proximal interventional device is still located in the lumen of catheter simultaneously. At least some distal tips of adjacent proximal interventional devices are maintained in the lumen of catheter and can be allowed to more easily reinsert and advance the proximal interventional device after pre-filling.

[0244] In some embodiments, axial overlap can be about 2 cm to about 20 cm, about 2 cm to 10 cm, about 2 cm to 5 cm, about 5 cm to 20 cm, about 5 cm to 10 cm, or any other suitable range.In some embodiments, axial overlap can be at least about 2 cm, at least about 5 cm, at least about 10 cm, at least about 20 cm, be no more than 2 cm, be no more than 5 cm, be no more than 10 cm, be no more than 20 cm, about 2 cm, about 5 cm, about 10 cm, about 20 cm or any other suitable amount.For example, in some embodiments, axial overlap can be about 2 cm, 3 cm, 4 cm, 5 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, + / - 0.5 cm.

[0245] In some embodiments, the robotically driven stage can be programmed to retract the internal interventional device proximally from the catheter to be primed as much as possible while still maintaining a nested or stacked relationship. In other embodiments, the robotically driven stage can be programmed to separate the internal device from the catheter to be primed to a distance sufficient to optimize the length of the unobstructed lumen and result in an amount of fluid resistance below a threshold. After the catheter to be primed is separated from the other interventional devices, the catheter can be primed by flushing the catheter with a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent).

[0246] After the catheter is primed, it can be returned to the initial position and the next catheter of the interventional device assembly can be separated from the other interventional devices within its lumen for primed. This sequence can be repeated for each catheter of the interventional device assembly. In other embodiments, after the catheter is primed, it can be advanced to a ready or driven position to begin insertion into the patient. Although the foregoing describes the separation of the catheter to be primed by retraction of the inner interventional device, the outer catheter can also be separated from the inner interventional device by axially advancing the outer catheter distally relative to the inner interventional device. Figures 22A to 22C , an example of the precharging process is described.

[0247] Figure 22A The interventional device assembly 2900 is depicted assembled in a concentrically stacked and axially compressed configuration. Figure 22A As shown, the interventional devices can be completely nested within each other. This can be the configuration after the device assembly 2900 is unpacked and placed on the robotic drive table. A series of priming can be initiated by axially advancing the catheter 2906 and hub 2914 distally relative to the catheter 2904, hub 2912, catheter 2902, hub 2910, guidewire 2907 and hub 2909, for example, as far as possible while maintaining the distal tip of the catheter 2904 within the lumen of the catheter 2906, as shown. Figure 22B As shown, or advanced to a distance that will result in the desired amount of fluid resistance for priming. In some embodiments, the catheter 2906 is advanced in response to a control signal from a control system. The catheter 2906 can then be primed by introducing a priming fluid using a fluid system. In some embodiments, the priming fluid is introduced in response to a control signal from a control system. The priming catheter 2906 may include a priming hub 2914. For example, in certain embodiments, the hub 2914 or a hemostatic valve connected thereto may include a fluidic connector to receive the priming fluid from the fluid system. After priming, the catheter 2906 can be returned to its initial position (e.g., a fully axially compressed configuration), as shown. Figure 22A In some embodiments, the catheter 2906 is returned to its initial position in response to a control signal from the control system.

[0248] After catheter 2906 is primed and returned to its initial position, catheter 2904 and hub 2912 can be advanced distally axially relative to catheter 2902, hub 2910, guidewire 2907, and hub 2909 (also advancing catheter 2906 and hub 2914 axially distally without changing or minimally changing their relative positions relative to catheter 2904), e.g., as far as possible while maintaining the distal tip of catheter 2902 within the lumen of catheter 2904, as shown. Figure 22CAs shown, or is advanced to a distance that will result in the desired amount of fluid resistance for priming. In some embodiments, catheter 2904 and catheter 2906 are advanced in response to a control signal from a control system. Catheter 2904 can then be primed by introducing a priming fluid using a fluid system. In some embodiments, the priming fluid is introduced in response to a control signal from a control system. The priming catheter 2904 may include a priming hub 2912. For example, in certain embodiments, the hub 2912 or a hemostatic valve connected thereto may include a fluidic connector to receive the priming fluid from the fluid system. After priming, catheter 2904 and catheter 2906 can be returned to their initial positions (e.g., a fully axially compressed configuration), as shown. Figure 22A In some embodiments, conduit 2904 and conduit 2906 are returned to their initial positions in response to a control signal from a control system.

[0249] After catheter 2904 is primed and returned to its initial position, catheter 2902 and hub 2910 can be axially advanced distally relative to guidewire 2907 and hub 2909 (also axially advancing catheter 2906, hub 2914, catheter 2904, and hub 2912 distally without changing 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 the desired amount of fluid resistance for priming. In some embodiments, catheter 2902, catheter 2904, and catheter 2906 are advanced in response to a control signal from a control system. Catheter 2902 can then be primed by introducing a priming fluid using a fluid system. In some embodiments, the priming fluid is introduced in response to a control signal from a control system. The priming catheter 2902 may include a priming hub 2910. For example, in some embodiments, hub 2910 or a hemostatic valve connected thereto may include a fluidic connection to receive priming fluid from the fluidic system. After priming, catheter 2902 and catheters 2904 and 2906 may be returned to Figure 22A 2902, 2904, and 2906 are shown in their initial positions (eg, fully axially compressed configuration). In some embodiments, conduit 2902, conduit 2904, and conduit 2906 are returned to their initial positions in response to a control signal from a control system.

[0250] In some embodiments, by 20A to 20C The described priming procedure can be performed in response to a single control signal from a control system. In other embodiments, the various steps of the priming procedure can be performed in response to unique control signals. In some embodiments, the priming of each unique interventional device can be performed in response to a unique control signal.

[0251] In an alternative embodiment, each of the catheters can be distally separated from each other 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 be distally separated from catheter 2904 while maintaining the distal tip of catheter 2904 within the lumen of catheter 2906. However, as shown by Figures 22A to 22C In the described embodiments, only one set of adjacent hubs is separated at a time, which can provide a smaller overall assembly length at any given time, which can allow for use with smaller robotic drive systems. Although separation of the outer catheters from their inner interventional devices is described as axially advancing the catheters distally relative to their inner interventional devices, separation can include proximally retracting the inner interventional devices from the outer catheters.

[0252] In an alternative embodiment, one or more of catheters 2902, 2904, and 2906 can be advanced to a ready or actuated position to initiate insertion into a patient after priming (e.g., before priming a subsequent catheter). In such an embodiment, the catheters can be advanced to the ready or actuated position without returning to their initial positions after priming.

[0253] As described above, in some embodiments, the catheters 2902, 2904, and 2906 can be assembled prior to flushing the catheter. Figure 17 The concentric stack shown is oriented to remove air by displacing it with a fluid (e.g., saline contrast or a mixture of saline and contrast). This is preferably done in each fluid lumen, e.g., the annular lumen between catheter 2906 and catheter 2904, and between each of the additional concentric interventional devices in the concentric stack. Infusing fluid (e.g., saline, contrast, or a mixture of saline and contrast) under pressure can displace substantially all of the air, but may retain some small bubbles that adhere to the inner wall of the outer catheter (e.g., guide catheter 2906), the outer wall of the inner catheter (e.g., surgical catheter 2904), or both.

[0254] When fluid is introduced into the proximal end of the annular lumen under pressure (e.g., into the hub of the outer catheter or into a hemostatic valve connected thereto), the inner catheter can move relative to the outer catheter to disrupt the holding force between the microbubbles and the adjacent wall and allow the bubbles to be carried downstream and expelled through the distal opening of the cavity or removed via suction. The catheters can move axially, rotationally, or axially and rotationally relative to each other. In certain embodiments, the catheters can move axially, rotationally, or axially and rotationally relative to each other. In some embodiments, the catheters can move reciprocally, axially, rotationally, or reciprocatingly axially and rotationally. In other embodiments, the catheters can rotate continuously or in a constant direction. In some embodiments, a drive mechanism (e.g., a magnetically connected drive system) that moves the catheter hub is used to move the catheter

[0255] In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, axially reciprocating over a stroke length of about 1 mm to about 250 mm, about 10 mm to about 250 mm, about 5 mm to about 125 mm, about 25 mm to about 125 mm, about 10 mm to about 50 mm, about 15 mm to about 30 mm, about 5 mm to about 30 mm, about 15 mm to about 25 mm, about 20 mm to about 40 mm, or any other suitable range. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, axially reciprocating over a stroke length of at least 5 mm, at least 10 mm, at least 15 mm, at least 20 mm, at least 25 mm, at least 30 mm, at least 50 mm, no more than 10 mm, no more than 20 mm, no more than 25 mm, no more than 30 mm, no more than 50 mm, no more than 125 mm, no more than 150 mm, about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 50 mm, or any other suitable stroke length.

[0256] In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, axially reciprocates at a reciprocating frequency of about 0.5 Hz to about 1 Hz, about 1 Hz to about 5 Hz, about 1 Hz to about 10 Hz, about 1 Hz to about 25 Hz, about 5 Hz to about 10 Hz, about 10 Hz to about 25 Hz, or any other suitable frequency range. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, axially reciprocates 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, no more than 0.5 Hz, no more than 1 Hz, no more than 2 Hz, no more than 5 Hz, no more than 10 Hz, no more than 25 Hz, about 0.5 Hz, about 1 Hz, about 2 Hz, about 5 Hz, about 10 Hz, about 25 Hz, or any other suitable frequency.

[0257] In one embodiment, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, axially reciprocating over a stroke length of about 0.5 inches to about 10 inches, or axially reciprocating over a stroke length of about 1 inch to about 5 inches at a reciprocating frequency of no more than about 5 cycles / second or two cycles / second or less.

[0258] In some embodiments, the first catheter is reciprocated relative to an adjacent catheter or guidewire, for example, at an angle 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 15 degrees to about 60 degrees, about 15 degrees to about 30 degrees, about 30 degrees to about 180 degrees, about 30 degrees to about 150 degrees, about 30 degrees to about 120 degrees, about 30 degrees to about 150 degrees. Rotatably reciprocates about an angle of rotation / stroke of about 90 degrees, about 30 degrees to about 60 degrees, about 60 degrees to about 180 degrees, about 60 degrees to about 150 degrees, about 60 degrees to about 120 degrees, about 60 degrees to about 90 degrees, about 90 degrees to about 180 degrees, about 90 degrees to about 150 degrees, about 90 degrees to about 120 degrees, about 120 degrees to about 180 degrees, about 120 degrees to about 150 degrees, about 150 degrees to about 180 degrees, or any other suitable range of rotation angles / strokes. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, rotationally reciprocating with a rotational angle / stroke of at least 5 degrees, at least 15 degrees, at least 30 degrees, at least 60 degrees, at least 90 degrees, at least 120 degrees, at least 150 degrees, at least 180 degrees, at least 360 degrees, no more than 5 degrees, no more than 15 degrees, no more than 30 degrees, no more than 60 degrees, no more than 90 degrees, no more than 120 degrees, no more than 150 degrees, no more than 180 degrees, no more than 360 degrees, about 5 degrees, about 15 degrees, about 30 degrees, about 60 degrees, about 90 degrees, about 120 degrees, about 150 degrees, about 180 degrees, about 360 degrees, or any other suitable angle.

[0259] In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, rotationally reciprocating at a reciprocating frequency of about 0.5 Hz to about 1 Hz, about 1 Hz to about 5 Hz, about 1 Hz to about 10 Hz, about 1 Hz to about 25 Hz, about 5 Hz to about 10 Hz, about 10 Hz to about 25 Hz, or any other suitable frequency range. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, rotationally reciprocating at a reciprocating frequency of at least 0.5 Hz, at least 1 Hz, at least 2 Hz, at least 5 Hz, at least 10 Hz, at least 25 Hz, no more than 0.5 Hz, no more than 1 Hz, no more than 2 Hz, no more than 5 Hz, no more than 10 Hz, no more than 25 Hz, about 0.5 Hz, about 1 Hz, about 2 Hz, about 5 Hz, about 10 Hz, about 25 Hz, or any other suitable frequency.

[0260] In some embodiments, the first catheter is reciprocated relative to an adjacent catheter or guidewire for a reciprocating number of times within a range of 1 to 200, 1 to 100, 1 to 50, 1 to 25, 1 to 15, 1 to 10, 1 to 5, 5 to 25, 5 to 15, 5 to 10, or any other suitable range. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire for at least 1 back and forth, at least 2 back and forth, at least 5 back and forth, at least 10 back and forth, at least 15 back and forth, at least 25 back and forth, at least 50 back and forth, no more than 5 back and forth, no more than 10 back and forth, no more than 15 back and forth, no more than 25 back and forth, no more than 50 back and forth, no more than 100 back and forth, no more than 200 back and forth, about 1 back and forth, about 2 back and forth, about 5 back and forth, about 10 back and forth, about 25 back and forth, about 50 back and forth, about 100 back and forth, about 200 back and forth, or any other suitable number of reciprocating movements. A reciprocating movement can include moving (axially or rotationally) from a first position to a second position and then returning to the first position from the second position.

[0261] In some embodiments, the first catheter is reciprocated and / or rotationally moved relative to an adjacent catheter or guidewire for a length of time from about 1 second to about 60 seconds, from about 1 second to about 45 seconds, from about 1 second to about 30 seconds, from about 1 second to about 20 seconds, from about 1 second to about 15 seconds, from about 1 second to about 10 seconds, from about 5 seconds to about 45 seconds, from about 5 seconds to about 30 seconds, from about 5 seconds to about 20 seconds, from about 5 seconds to about 15 seconds, from about 5 seconds to about 10 seconds, from about 10 seconds to about 30 seconds, from about 10 seconds to about 20 seconds, or any other suitable range. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire for a period of at least 1 second, at least 5 seconds, at least 10 seconds, at least 15 seconds, at least 20 seconds, at least 30 seconds, at least 45 seconds, at least 60 seconds, no more than 5 seconds, no more than 10 seconds, no more than 15 seconds, no more than 20 seconds, no more than 30 seconds, no more than 45 seconds, no more than 60 seconds, about 5 seconds, about 10 seconds, about 15 seconds, about 20 seconds, about 30 seconds, about 45 seconds, about 60 seconds, or any other suitable period of time.

[0262] The reciprocating movement of adjacent catheters to destroy microbubbles can be accomplished by manually grasping the corresponding catheter hubs and manually moving the catheters axially or rotationally relative to each other while delivering a pressurized fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent). Alternatively, for example, in a robotically driven system, the processor can be configured to robotically drive at least one of two adjacent catheter hubs (e.g., at least one of hub 2914 and hub 2912) to achieve relative movement between adjacent catheters to destroy and expel 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 each other in response to a control signal from a control system. In certain embodiments, the delivery of the pressurized fluid can be performed in response to a control signal from a control system.

[0263] The reciprocating movement of adjacent conduits can produce the shearing force that removes bubbles.For example, compared with static surface, the relative movement of the inner surface and the outer surface of adjacent conduits can increase the fluid shear rate between adjacent conduits during prefilling.In some embodiments, shearing force can be increased by increasing the flow velocity of the solution (for example, saline, contrast agent, or the mixture of saline and contrast agent) provided by the fluid system.In certain embodiments, the flow velocity and relative movement between the control adjacent conduits are to remove bubbles.

[0264] In some embodiments, after each catheter is primed with the fluid system, an ultrasonic bubble detector can be used to confirm that the catheter is substantially free of bubbles. For example, an ultrasound chip (e.g., mounted within a hub adjacent to the catheter receiving lumen) can be extended along the length of the catheter to confirm that no bubbles remain in the system.

[0265] pass FIG. 23A to FIG. 23B An example of a priming procedure involving reciprocating movement of adjacent catheters is described.

[0266] Figure 23A The interventional device assembly 2900 is depicted assembled in a concentric stacked configuration. Figure 23A As shown, the interventional devices can be completely nested within each other. This can be the configuration after the device assembly 2900 is unpacked and placed on the robotic drive table. Alternatively, the individual interventional devices of the device assembly 2900 can be assembled into the device assembly 2900 on the drive table.

[0267] A series of priming can be initiated by priming catheter 2906. In some embodiments, catheter 2906 can be primed by introducing a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of catheter 2906 while causing axial, rotational, or axial and rotational reciprocating movement of catheter 2906 and / or hub 2914 relative to catheter 2904. The priming catheter 2906 can include a priming hub 2914. For example, in certain embodiments, hub 2914 or a hemostatic valve connected thereto can include a fluidic connector to receive priming fluid from a fluid system. In certain embodiments, catheter 2906 and / or hub 2914 can be positioned along the longitudinal axis of catheter 2906 (e.g., at Figure 23A location and Figure 23B The axial and / or rotational reciprocating motion of the conduit 2906 and / or hub 2914 can be performed manually or by a robotically driven stage. The reciprocating motion can be generated in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0268] In some embodiments, priming of the catheter 2906 can be performed by introducing a fluid (e.g., saline, a contrast agent, or a mixture of saline and a contrast agent) under pressure into the lumen of the catheter 2906 while simultaneously causing axial, rotational, or axial and rotational reciprocating movement of the catheter 2904 and / or hub 2912 relative to the catheter 2906. The axial and / or rotational reciprocating movement of the catheter 2904 and / or hub 2912 can be performed manually or by a robotic drive stage. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0269] In some embodiments, priming of catheter 2906 can be performed by introducing a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of catheter 2906 while simultaneously causing axial, rotational, or axial and rotational reciprocating movement of catheter 2906 (and / or hub 2914) and catheter 2904 (and / or hub 2912) relative to each other. The reciprocating movement can be caused in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0270] In some embodiments, after priming the catheter 2906, the catheter 2906 can be returned to the Figure 23A 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.

[0271] In some embodiments, after catheter 2906 is pre-filled, catheter 2904 can be pre-filled. Pre-filling catheter 2904 can include a pre-filling hub 2912. For example, in certain embodiments, hub 2912 or a hemostatic valve connected thereto can include a fluidic connector to receive a pre-fill fluid from a fluid system. In some embodiments, catheter 2904 can be pre-filled by introducing a fluid (e.g., saline, a contrast agent, or a mixture of saline and a contrast agent) under pressure into the lumen of catheter 2904 while simultaneously causing axial, rotational, or axial and rotational reciprocating movement of catheter 2904 and / or hub 2912 relative to catheter 2902. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0272] In some embodiments, priming of the catheter 2904 can be performed by introducing a fluid (e.g., saline, a contrast agent, or a mixture of saline and a contrast agent) under pressure into the lumen of the catheter 2904 while simultaneously causing axial, rotational, or axial and rotational reciprocating movement of the catheter 2902 and / or hub 2910 relative to the catheter 2904. The axial and / or rotational reciprocating movement of the catheter 2902 and / or hub 2910 can be performed manually or by a robotic drive stage. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0273] In some embodiments, priming of catheter 2904 can be performed by introducing a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of catheter 2904 while simultaneously causing axial, rotational, or axial and rotational reciprocating movement of catheter 2904 (and / or hub 2912) and catheter 2902 (and / or hub 2910) relative to each other. The reciprocating movement can be caused in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0274] In some embodiments, after priming the catheter 2904, the catheter 2904 can be returned to the Figure 23A In some embodiments, after priming catheter 2904, catheter 2904 can be advanced to a ready or actuated position to begin insertion into the patient.

[0275] In some embodiments, after catheter 2904 is pre-filled, catheter 2902 can be pre-filled. Pre-filled catheter 2902 may include a pre-filled hub 2910. For example, in certain embodiments, hub 2910 or a hemostatic valve, a three-way valve, or other fluid control valve connected thereto may include a fluidic connector to receive pre-filled fluid from a fluid system. In some embodiments, catheter 2902 can be pre-filled by introducing a fluid (e.g., saline, a contrast agent, or a mixture of saline and a contrast agent) into the lumen of catheter 2902 under pressure while generating axial, rotational, or axial and rotational reciprocating movement of catheter 2902 and / or hub 2910 relative to guidewire 2907. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of fluid under pressure can be performed in response to a control signal from a control system.

[0276] In some embodiments, priming of the catheter 2902 can be performed by introducing a fluid (e.g., saline, a contrast agent, or a mixture of saline and a contrast agent) under pressure into the lumen of the catheter 2902 while simultaneously causing axial, rotational, or axial and rotational reciprocating movement of the guidewire 2907 and / or hub 2909 relative to the catheter 2902. The axial and / or rotational reciprocating movement of the guidewire 2907 and / or hub 2909 can be performed manually or by a robotic drive station. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0277] In some embodiments, priming of the catheter 2902 can be performed by introducing a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of the catheter 2902 while simultaneously causing the catheter 2902 (and / or hub 2910) and the guidewire 2907 (and / or hub 2909) to reciprocate axially, rotationally, or both axially and rotationally relative to each other. The reciprocating movement can be caused in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0278] In some embodiments, after priming the catheter 2902, the catheter 2902 can be returned to the Figure 23A 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.

[0279] In some embodiments, by Figure 23A and Figure 23BThe described priming procedure can be performed in response to a single control signal from a control system. In other embodiments, the various steps of the priming procedure can be performed in response to unique control signals. In some embodiments, priming of a unique interventional device can be performed in response to a unique control signal.

[0280] In this article through Figure 23A and Figure 23B In the series of priming described, the catheters are primed sequentially, starting with catheter 2906, followed by catheter 2904, and then catheter 2902. However, it is contemplated that the catheters may be primed in any order. The catheters may be primed as described above. Figure 23A and Figure 23B Alternatively, two or more catheters, or each catheter, may be primed in parallel.

[0281] In certain embodiments, the priming of the catheter may include reducing the depth of axial insertion (i.e., axial overlap) of the second interventional device into the lumen of the first interventional device through which the fluid is injected (e.g., the length of the second interventional device into its concentrically adjacent lumen), such as by Figures 22A to 22C As described, and also during priming, relative reciprocating movement is generated axially, rotationally, or axially and rotationally between the first interventional device and the second interventional device, such as by Figure 23A and Figure 23B described.

[0282] Fluid management system and method

[0283] Figure 26A An embodiment of a channel of a multi-channel fluid management system 2600 is shown. Fluid management system 2600 can be configured as an automated system to manage the delivery of fluid to a patient or the extraction of material from a patient via one or more interventional devices (e.g., catheters). As shown, system 2600 can manage the delivery of fluid to a patient during a medical procedure. Fluid management system 2600 includes at least one fluid source and / or tank 2612 connected to valve 2614, which is connected to manifold 2616. Manifold 2616 is remote (e.g., on a support table or on a rack outside the sterile area) or is connected to a catheter hub 2618, which is connected to at least one source and / or tank line 2116. Source and / or tank line 2116 is connected to at least one catheter 120 via hub 2818.

[0284] In some embodiments, the fluid source and / or tank 2612 comprises a reservoir of a volume of fluid and a means for propelling such fluid to another component of the system 2600, or a means for recovering the fluid to the source. Example propulsion means may include one or more thrusters, pushers, syringes, and / or pumps to circulate and / or recover fluid throughout the system 2600. In some embodiments, the propulsion means may be used to control volume, flow rate, and / or pressure. In certain embodiments, the propulsion means may be activated to propel the fluid to another component of the system or to retrieve the fluid from the system, or may be deactivated to stop the movement of the fluid.

[0285] In some embodiments, for each conduit configured for a specific medical operation, the fluid management channel is substantially the same. Based on the interventional device connected to each fluid channel, different channels can be differentiated in the sensors, pumps, and / or valves used. For example, the fluid system for a surgical conduit (e.g., for suction) can include an in-line vacuum pump and a filter. In addition, for example, the fluid system for guiding, entering, or inserting a conduit can include an in-line drip rate sensor, a bubble sensor, a pressure sensor, and / or a bubble filter.

[0286] Source and / or sink 2612 represents a fluid source or fluid sink (e.g., a waste tank). For example, a fluid source may include a container suitable for holding a fluid (e.g., saline, contrast media, medication, blood, plasma, or other fluid) for use with the fluid management system 2600. The container may be configured to release the fluid into a fluid delivery line (e.g., a fluid delivery tube) using active means (e.g., a pump, vacuum, etc.) or passive means (e.g., gravity). A fluid sink may include a container suitable for receiving fluid (e.g., aspirate, thrombus, particles, saline, contrast media, medication, blood, other fluids, or combinations thereof) from a patient and / or other fluid infrastructure within the fluid management system 2600.

[0287] Valve 2614 represents one or more valves that are connected to source 2612 and / or sink 2612 on a first side of valve 2614 and to manifold 2616 on a second side of valve 2614. Manifold 2616 is configured to connect each valve 2614 to a specific hub 2618. In some embodiments, valve 2614 can alternatively be connected directly to hub 2618 to avoid the use of a separate manifold 2616. In some embodiments, manifold 2616 can be integrated into the hub. In some embodiments, second valve 2614 can connect manifold 2616 to hub 2618. For example, second valve 2614 can be connected to manifold 2616 on a first side and to hub 2618 on a second side.

[0288] The hub 2618 is configured to be releasably or non-releasably connected to an interventional device (catheter, guidewire, guide element or other medical device). For example, the catheter 120 has a proximal end attached to a unique hub 2618, which is sometimes referred to as a "puck". In some embodiments, the hub 2618 can be moved along a path on the surface of the robot drive table to advance or retract the catheter 120 (or other medical and / or interventional device). Each hub 2618 can also include certain mechanisms for rotating or deflecting the catheter 120 or guidewire as needed. The hub 2618 can be connected to a fluid delivery tube (e.g., source / slot line 2116) to provide fluid release or fluid capture. Each hub 2618 can be electrically connected to an electronic control system via a hard-wired connector, an RF wireless connector, or a combination of the two. Additional details of the hub, drive platform, and related systems can be found in U.S. patent application Ser. No. 17 / 816,669, filed on August 1, 2022, entitled “Method of Supra-Aortic Access for a Neurovascular Procedure,” which is expressly incorporated herein in its entirety.

[0289] Any hub disclosed herein may also include one or more fluid injection ports and / or wireless RF transceivers for communication and / or power transfer. In some embodiments, the hub 2618 may also include a wired electrical communication port and a power supply port.

[0290] In some embodiments, the hub 2618 or the tubing 2116 leading to the hub 2618 can include a visual indicator for indicating the presence of aspirated clot. The visual indicator can include a clot chamber having a transparent window. A filter can be positioned 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, filed October 18, 2021, entitled "Device for Clot Retrieval," which is expressly incorporated herein in its entirety.

[0291] Any hub or interventional device disclosed herein may also include a sensor for detecting a parameter of interest, such as the position or orientation of the distal tip or the state of the distal tip of the interventional device. The state of the distal tip may 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 sensor may be positioned on the flexible body of the interventional device. The sensor may include a pressure sensor to capture the arterial blood pressure waveform at the distal end of the catheter, or may include an optical sensor to determine captured clots or bubbles. In some embodiments, the sensor may 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 sensor may 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 the applied force.

[0292] Figures 26B to 43Shown is a schematic diagram of the operation of a multichannel fluid system, a part of a multichannel fluid system or a multichannel fluid management system. These fluid systems and other systems as described herein (such as drive systems) and components can provide fluid to the target site of a patient's vascular system through one or more catheters. For example, these systems can include a catheter with a tubular catheter shaft, wherein the tubular catheter shaft has a proximal end, a distal end and a lumen defined by the inner surface of the catheter shaft, and the lumen extends longitudinally through the catheter shaft between the proximal end and the distal end. These systems can also include a guiding element with a distal end, a proximal end and an outer surface, wherein the guiding element is configured to be positioned in the lumen of the catheter, produces an area between the outer surface of the guiding element and the inner surface of the catheter, and the area has an effective cross-sectional area for fluid communication of a certain amount of fluid under a certain pressure. In some embodiments, the effective cross-sectional area is equal to or greater than 0.001257 square inches, which allows the fluid (such as contrast agent) of the desired amount to flow through the lumen when the guiding element is positioned in the lumen to provide the desired fluid. For example, the system can include a contrast agent pump connected to the catheter (being communicated with the lumen fluid). The system is configured to receive a signal to actuate a contrast agent pump to provide contrast agent to the proximal end of the catheter at a pump pressure of less than or equal to about 400 psi, while the guide element is at least partially positioned in the lumen of the catheter, so that the provided contrast agent propagates along the outer surface of the guide element, through the lumen of the catheter, and out of the distal end of the catheter. The effective cross-sectional area allows the contrast agent to flow out of the distal end of the catheter at a predetermined flow rate (e.g., at least about 3 cc's per second). For example, the viscosity of the contrast agent is greater than 1 cP to about 30 cP. That is, the contrast agent has a viscosity greater than 1 cP, or 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, + / - 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 agents, which may require high pressure to communicate through the lumen of a catheter.

[0293] Figure 26BA schematic diagram of a multi-channel fluid management system 2610 is shown having a first source 2612a, a second source 2612b, and a sink 2612c. The first source 2612a is connected to a valve 2614a. The second source 2612b is connected to a valve 2614b. The sink 2612c is connected to the valve 2614c. Valves 2614a, 2614b, and 2614c are part of a valve manifold 2616. The valve manifold 2616 is connected 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 located 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 a hemostatic valve. In other embodiments, the valve manifold 2616 is located remotely from the hemostatic valve and is connected to the hemostatic valve via one or more fluid lines. Valves 2614a, 2614b, and 2614c can be opened and closed to selectively place first fluid source 2612a, second fluid source 2612b, and tank 2612c in communication with the lumen of catheter 120. For example, valve manifold 2616 can include fluid ports (e.g., first port 2615a associated with valve 2614a, second fluid port 2615b associated with valve 2614b, and third port 2615c associated with valve 2614c) that can be selectively placed in communication with, or blocked from, the lumen of catheter 120. For example, in some embodiments, one of the first, second, and third ports can be placed in communication with the lumen of catheter 120, while the other two ports are blocked from communication with catheter 120.

[0294] In some embodiments, first source 2612a can be a source of heparinized saline. Source 2612b can be a source of contrast solution. In some embodiments, one or more of sources 2612a, 2612b, and 2612c can be connected to multiple manifolds 2616, each manifold 2616 connected to a unique interventional device 2618. The valve manifold 2616 shown herein can be used in any of the systems described herein.

[0295] Figure 27 A schematic diagram of a three-channel fluidic system 2700 for use with a fluid management system 2600 comprising a stack of four concentrically arranged interventional devices is shown. The fluidic system 2700 shown here comprises a fluid management section 2702 and an interventional section 2704. In some embodiments, the interventional section 2704 can comprise a concentric catheter and guidewire stack configured for manual manipulation by a physician. In some embodiments, the interventional section 2704 can comprise a concentric catheter and guidewire stack configured for manipulation by a robotic drive system. In some embodiments, the interventional section 2704 comprises a combination of robotically driven medical devices and manually manipulated medical devices.

[0296] Components of the fluid management section 2702 can be located outside the sterile field or within the sterile field. In some embodiments, the fluid management section 2702 is located outside the sterile field but is connected to the access section 2704 located within the sterile field via flexible tubing and flexible electrical conductors.

[0297] The fluid management unit 2702 may include at least two or three or more Figure 26A Channels of the type shown (e.g., parallel channels) are each used for a separate fluid source or fluid sink. In the illustrated embodiment, the fluid management section 2702 includes three channels, each of which communicates with each of the three conduits through a corresponding conduit hub. Two channels each provide for the delivery of two different fluids to each conduit at controllable pressures, volumes, and delivery rates. The third channel provides suction from each conduit to the sink.

[0298] Each of the two or more fluid channels can be primed by completely degassing and filling the corresponding fluid to prepare for transport into the catheter and body cavity. In some embodiments, the fluid lines, catheters, and / or catheter lumens can be flushed and primed with fluid (e.g., saline) at the same time.

[0299] In some embodiments, the systems 2700, 2800 can be configured to backfill each tank connection of each catheter with fluid (e.g., saline) at the beginning of a procedure and / or between fluid steps. This can provide a backfill column of saline downstream of the tank connection, for example, to ensure that a contrast injection flows to the distal end of a particular catheter rather than the tank. In some embodiments, the systems 2600, 2700 can be configured to provide a backfill column of saline upstream of a saline valve at the hub, for example, to ensure that a contrast injection flows to the distal tip or tank of a particular catheter rather than through the saline valve.

[0300] like Figure 27 As shown, the fluid management portion 2702 of the fluid system 2700 includes a first source 2710a, a second source 2710b, and a trough 2712. Sources 2710a and 2710b can each be configured to hold and dispense at least one fluid (e.g., saline, contrast media, medication, blood, or other fluids, or combinations thereof). Trough 2712 can be configured to receive waste fluid and / or waste products from a selected aspiration line leading to a corresponding catheter. Although two fluid sources and one fluid trough are shown, any number of fluid sources and / or fluid troughs corresponding to the fluid delivery and / or aspiration requirements of a particular procedure is possible (e.g., one fluid source and one fluid trough, two fluid sources without a fluid trough, more than two fluid sources, etc.).

[0301] A plurality of valves (and / or valve arrays) are provided to stop and start the flow of respective fluids to or through one or more fluid lines and / or hubs within sections 2702 and / or 2704. In the illustrated embodiment, a first valve array 2716a (e.g., having three valves) is carried by a first manifold 2718a, a second valve array 2716b (e.g., having three valves) is carried by a second manifold 2718b, and a third valve array 2716c (e.g., having three valves) is carried by a third manifold 2718c. Although a valve array having three valves is shown, any number of valves is possible and can correspond to the number of catheters and / or fluid sources used in a procedure or a subset of interventional devices used in a procedure. For example, in some cases, each valve array can include at least one valve, two valves, three valves, or four or more valves.

[0302] 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 the corresponding conduit. In some embodiments, each valve in a valve array can be adjusted independently and / or simultaneously for a corresponding conduit and / or more than one conduit.

[0303] In the illustrated embodiment, the fluid pathways are identical for each conduit, and therefore will only be described with reference to source 2710a below. A first outflow valve 2717a is connected to a first conduit 2726 via a unique source line 2720a. A second outflow valve 2717b is connected to a second conduit 2728 via a unique source line 2720b. A third outflow valve 2717c is connected to a third conduit 2730 via a unique source line 2720c. Each valve 2717a to 2717c is preferably electronically actuated between fully closed, fully open, or partially open positions in response to a signal from a control system. Any of a variety of valve mechanisms can be used, such as a ball valve driven by a stepper motor, a solenoid, a plug valve (e.g., a rotary plug valve), a rotary valve, or other actuators known in the art. The actuator can provide automated control and sequencing of the valves. For example, a stepper motor with built-in coding can be used to achieve valve actuation, providing consistent switching and sequencing. The actuator can be controlled by an engine controller of a user control interface (e.g., a computer system). A control system may include modules that read values ​​from sensors (eg, flow, air bubbles, pressure, etc.) and display those values ​​to control the behavior of the fluid system.

[0304] In some embodiments, a stopcock mechanism (e.g., a rotary stopcock) can be used in the manifolds described herein. For example, one or more stopcocks can be placed near a hub (or integrated into the hub) to avoid managing fluid columns in a particular conduit. Such conduits can be disposable, sterile, disposable conduits. Placing a manifold with stopcocks near or integrated into the hub has the advantage of simplicity, without the need to manage fluid columns in the conduits. Keeping the manifold valves and stopcocks away from the hub can allow the manifold valves and stopcocks to be used with non-sterile equipment outside the sterile field. This configuration can provide the advantage of maintaining component sterility in the sterile field.

[0305] In some embodiments, the fluid control system may further include a drive mechanism configured to adjust the sealing strength of the hemostatic valve in response to a signal from the control system, such as a signal from a processor of the control system. The control system (e.g., a processor) may be configured to increase the sealing strength of the hemostatic valve in response to manipulation of the contrast agent control member to introduce contrast agent into the catheter. The control system (e.g., a processor) may additionally be configured to reduce the sealing strength of the hemostatic valve in response to manipulation of the contrast agent control member to stop introducing contrast agent into the catheter. In some embodiments, the control system (e.g., a processor) may be configured to reduce the sealing strength of the hemostatic valve in response to a received signal to drive a catheter or guidewire through the hemostatic valve. Such a feature may provide advantages such as reducing friction between the hemostatic valve and the moving catheter shaft.

[0306] In operation, all three valves 2717a to 2717c can be in an open configuration to allow saline to flow through each of the three conduits. The forward flow of saline (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). Alternatively, depending on the desired performance, any one valve can be opened and the other two closed. Alternatively or additionally, the other volume and / or pressure source (e.g., pump 2714) can be deactivated or disconnected to prevent flow.

[0307] exist Figure 2In the stack of concentric catheters shown, 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 of about 0.060 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 of about 0.025 inches to about 0.050 inches; in an example, the inner diameter is about 0.045 inches to about 0.049 inches. The guidewire 2732 can have an outer diameter of about 0.014 to about 0.020 inches. In a specific 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.

[0308] 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 130), which can be different from the available lumen in the third catheter 2739 (which can be the difference between the ID of the third catheter 2730 or the ID of the third catheter 130 and the OD of the guidewire 2732). In order to produce the same delivered infusion flow rate through each catheter, the control system can be configured to adjust each of the pumps 2714 and / or valves 2717a to 2717c to compensate for the difference in the effective cross-section of each corresponding flow path, so as to achieve the same delivered flow rate through each catheter. The system can use a parameter file associated with the attached device (catheter and guidewire) that has device size information (e.g., ID, OD, length). The system can adjust the pump based on the size information as well as information regarding the fluid communicated within the catheter (eg, the density and / or viscosity of the contrast agent communicated through the catheter lumen).

[0309] In one embodiment of the present invention, the catheter may be assembled into a tube prior to flushing the catheter to displace the air with a fluid such as saline to remove the air. Figure 2 The concentric stacked orientation shown. This is preferably achieved in each fluid lumen, for example, the annular lumen between the first catheter 2726 and the second catheter 2728, and between each of the additional concentric interventional devices in the stacked orientation. Infusing saline under pressure can displace substantially all of the air, but some small bubbles may remain, for example, adhering to the inner wall of the first catheter 126, the outer wall of the second catheter 2728, or both.

[0310] When saline is introduced under pressure into the proximal end of the annular lumen between two interventional devices (e.g., the annular lumen between the first catheter 2726 and the second catheter 2728), the inner catheter can move relative to the outer catheter (e.g., the second catheter 2728 can move relative to the outer catheter) to disrupt the holding forces between the microbubbles and the adjacent wall and allow the bubbles to be carried downstream and out through the distal opening of the lumen. The catheters can move axially, rotationally, or both relative to each other. In one embodiment, the first catheter reciprocates relative to the adjacent catheter or guidewire, for example axially through a range of about 0.5 inches to about 10 inches or about 1 inch to about 5 inches at a reciprocating frequency of no more than about 5 cycles per second or two cycles per second or less.

[0311] Reciprocating movement of adjacent catheters to destroy microbubbles can be achieved by manually grasping the corresponding catheter hubs and manually moving the catheters axially or rotationally relative to each other while delivering pressurized saline. Alternatively, for example, in a robotically driven system, the processor can be configured to robotically drive at least one hub (e.g., at least one of hub 2724a and hub 2724b) of two adjacent catheters to achieve relative movement between the adjacent catheters to destroy and expel microbubbles, for example in response to user activation of a flush control.

[0312] Source 2710b is in fluid communication with manifold 2718b, allowing fluid to flow to any number of valves (e.g., three) in valve array 2716b as shown in arrow 2722b. The forward flow of contrast agent (in the direction of arrow 2722b) can be driven by pump 2736, such as a syringe pump, a high-pressure positive displacement pump, a contrast agent injection pump, etc. Any one valve of valve array 2716b can be opened, while the other two are closed, depending on the required performance. Alternatively or additionally, other volume and / or pressure sources (e.g., pump 2736) can be deactivated or disconnected to prevent flow. The proximal opening of each source line 2721a, 2721b, 2721c can be connected to the corresponding output port on the corresponding valve in valve array 2716b. The distal opening of each source line 2721a, 2721b, 2721c can be connected to each corresponding hub 124a, 2724b, 2724c, and thereby connected to a corresponding catheter 2726, catheter 2728, and / or catheter 2730. The corresponding catheter 2726, catheter 2728, catheter 2730, and / or guidewire 2732 can be guided into the patient's body (not shown). Additional hubs and / or catheters can be added to the system 2700, and corresponding fluid management system components (e.g., system 2600) can be added to the system 2700. In other embodiments, the system 2700 can include fewer hubs and / or catheters, such as two hubs and / or catheters.

[0313] Trough 2712 is connected to manifold 2718c to receive fluid from suction lines 2723a, 2723b, 2723c in the direction indicated by arrow 2722c. The suction lines are configured to receive fluid and embolic material from one, two, or all three corresponding catheters 126, 128, and 130, depending on input from the physician to the control system. Once the physician has determined which catheter(s) will be placed in suction mode and activated the corresponding suction control, the corresponding valve within valve array 2716c can be opened in response to the control system activating suction pump 2715 to allow fluid to flow through the corresponding catheter and into trough 2712. Any one valve of valve array 2716c can be opened while the other two are closed, depending on the desired performance. Alternatively or additionally, other volume and / or pressure sources (e.g., pump 2715) can be deactivated or disconnected to prevent flow.

[0314] In an exemplary embodiment, fluid system 2700 shows an aspiration configuration, wherein source 2710a contains heparinized saline and source 2710b contains contrast medium solution. In this example, tank 2712 may contain waste blood / saline / embolic material aspirated from a patient (not shown). Other additional sources and / or tanks may be used in combination with corresponding fluids.

[0315] Similarly, the contrast agent solution contained in source 2710b can flow in the direction of arrow 2722b and can flow into manifold 2718b. In a given operation, the doctor can determine to inject contrast agent through any of the three catheters, and generally inject contrast agent through the most distal catheter at a given injection time. In response to the command to inject contrast agent, the control system will open the valve corresponding to the selected catheter, and generally the other two valves remain closed. In some embodiments, the doctor can inject contrast agent into two or more catheters at the same time. In some embodiments, for example, contrast agent can be applied or suctioned simultaneously while the catheter or guidewire is being driven.

[0316] In some embodiments, each valve (or valve array) can be contained in corresponding hub 2724a, 2724b, 2724c or carried by corresponding hub 2724a, 2724b, 2724c. In some embodiments, each valve (or valve array) can be contained near corresponding hub or away from corresponding hub. In such an example, additional fluid lines (e.g., 2720, 2721, 2723) can be added between each manifold and corresponding valve. Fluid lines 2720a to 2720c, 2721a to 2721c and 2723a to 2723c can be tubes. In some embodiments, any one of fluid lines 2720a to 2720c, 2721a to 2721c and 2723a to 2723c can be detachably connected to their respective hubs. Alternatively, any of the fluid lines 2720a-2720c, 2721a-2721c, and 2723a-2723c may be inseparably connected to the hub and removably connected to other components of the fluid management portion 2702, such as the valve arrays 2716a-2716c or the manifolds 2718a-2718c.

[0317] In some embodiments, the fluid system 2700 may also include any number of pressure sensors, volume sensors, flow rate sensors, tubing sets, connectors, and bubble sensors / detectors, as will be discussed. In the illustrated embodiment, pressure transducer 2734a is in pressure sensing communication with the first conduit 2726 via hub 2724a. As shown, additional pressure transducers 2734b, 2734c may be provided as shown in communication with their respective conduits.

[0318] The control system can be configured to automatically adjust the various manifold valves, pumps, and hemostasis valves (discussed below) in response to commands input by the physician. For example, the physician can input a command to infuse contrast media through the third conduit 2730. The control system can automatically cause a series of responsive events to occur. At least the saline valve 2717c will close. Valves 2717a and 2717b can be closed, or can remain open to provide positive pressure through the first and second conduits to prevent backflow of contrast media.

[0319] A control signal will be sent to the hemostatic valves in each of the first and second catheter hubs 2724a, 2724b to clamp down from a low-pressure slip fit to a high-pressure clamp around the second and third catheters 2728, 2730, respectively. This will prevent contrast media from escaping proximally through the first and second catheters 2726, 2728. Additionally, a control signal will be sent to valve 2719c to place the third catheter 2730 in fluid communication with the second source 2710b of contrast-containing solution.

[0320] If the space between the OD of the guidewire 2732 and the ID of the 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 of the control hub 2724d to retract the guidewire 2732 proximally from the third catheter 2730 a distance sufficient to allow contrast to flow through the catheter 2730. Additional control signals can be sent to the hemostasis valve carried by the hub 2724c to clamp around the distal end of the guidewire 2732 in a high pressure mode, or to clamp into a fully closed configuration if the guidewire 2732 is fully retracted. Further control signals can be sent to an electronically activated high pressure pump 2736, such as a syringe pump, a high pressure positive displacement pump, a contrast agent syringe pump, etc., to deliver the contrast solution through the third catheter 2730.

[0321] If the physician initiates a command to perform aspiration through, for example, first catheter 2726, the control system can automatically send another series of control signals to execute the command. A signal will be sent to each hemostasis valve to move them from a high-pressure configuration to a low-pressure configuration, in which less friction is generated on the shaft of the catheter or guidewire. This configuration can allow relative movement of the various devices and proximal retraction of the second and third catheters 2728, 2730 from the first catheter 2726, while still preventing proximal blood loss through the hemostasis valves. A signal will be sent to the drive system to proximally retract each of hubs 2724b, 2724c, and 2724d. Valve 2723a will be opened to place first catheter 2726 in fluid communication with groove 2712. A signal will be sent to activate vacuum pump 2715, thereby aspirating blood and thrombus into groove 2712. In some embodiments, for example, when aspiration of the first conduit 2726 is performed, communication between the conduit 2726 and the first and second fluid sources 2710a, 2710b can be blocked. For example, the corresponding valves of the valve arrays 2716a and 2716b can be closed to block the manifolds 2718a and 2718b. Alternatively, the volume and / or pressure sources (e.g., pumps 2714 and 2736) can be deactivated or disconnected.

[0322] All fluid lines between the first source 2710a and the second source 2710b and each catheter, and all fluid lines between the tank 2712 and each catheter are preferably completely flushed free of air bubbles and filled with a fluid, such as saline, during system preparation prior to surgery. This allows for seamless transitions between infusion, aspiration, and manipulation of the catheter and guidewire without the need to disconnect and reconnect any fluid lines between the sources, tanks, and catheters, eliminating the risk of introducing air emboli during such exchanges.

[0323] It is also desirable to be able to confirm that there are no bubbles in any of the fluid lines. This can be accomplished by placing a bubble sensor near each of the fluid lines, such as in or upstream of each hub, or at the manifold. This may be particularly desirable in telemedicine applications where the physician is located at a remote workstation and out of direct line of sight of the patient.

[0324] This can be achieved using non-contact ultrasonic sensors that measure the intensity and Doppler shift of reflected ultrasound passing through the sidewalls of the fluid conduit to detect bubbles and measure fluid flow rate or fluid level. The ultrasonic or optical sensor can be located near the incoming fluid flow path within the hub or in the supply line leading to the hub.

[0325] For example, to detect the presence of bubbles (formed from ultrasound or light-transmitting materials) in an infusion line, a sensor may 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 the transmission through the liquid flowing through the tubing to detect the bubbles. Alternatively, due to the relatively high echogenicity of bubbles, a reflected ultrasound signal may be detected from the same side of the flow path as the source.

[0326] Alternatively, an optical sensor may be provided to detect changes in optical transmission or reflection due to the presence of bubbles, or to transmit a visual signal to a display at a remote workstation where the physician can visually observe the presence of bubbles moving through the tubing. In systems with bubble detectors, the control system may be configured to automatically shut off all fluid flow in response to detection of bubbles, providing personnel with an opportunity to plan next steps.

[0327] In one embodiment, a bubble removal system is automatically activated upon detection of bubbles in the line. The processor can be configured to activate a valve in the flow path downstream of the bubble detector upon detection of bubbles. The valve diverts the fluid column containing the detected bubbles out of the flow path to the patient and instead into a bypass flow path or reservoir. Once bubbles are no longer detected in the flow path and the volume of fluid in the flow path between the detector and the valve has passed through the valve, the valve can be activated to reconnect the fluid source to the patient through the flow path. In some embodiments, the flow path can include any number of bubble filters and / or traps to remove bubbles from the flow path.

[0328] The robotic system portion 2704 may include a drive station configured to receive (e.g., connect to) any number of hubs (2724a, 2724b, 2724c, 2724d, etc.). Additional details of the hubs, drive stations, and related systems can be found in U.S. patent application Ser. No. 17 / 816,669, filed on August 1, 2022, entitled “Method of Supra-Aortic Access for a Neurovascular Procedure,” which is expressly incorporated herein in its entirety. Each hub is configured to connect to a catheter or guidewire, one or more fluid lines, one or more electrical wires, one or more controls, and / or one or more displays. For example, the drive station may be positioned above or beside the patient and configured to support axial advancement, retraction, and in some cases rotation 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.).

[0329] The drive system independently drives each hub to move independently in a proximal or distal direction across the surface of the table 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.

[0330] As described elsewhere herein, in response to movement of the corresponding hubs 2724a, 2724b, and 2724c, the corresponding catheters 2726, 2728, 2730, and / or guidewires 2732 can be guided into a body cavity (not shown) as a single concentric catheter stack. The system 2700 can also include a guidewire hub 2724d for controlling the guidewire 2732, which can also be introduced into the body cavity along with one or more of the catheters 2726, 2728, and / or 2730.

[0331] 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 so 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.

[0332] Because multiple sources and / or sinks are configured to each be connected (and remain connected) to each catheter hub (e.g., hubs 2724a, 2724b, and 2724c), fluid system 2700 provides the advantage of enabling faster procedures than conventional fluid systems (which employ manual removal, addition, and / or switching of fluids, catheters, hubs, etc.) during surgery. For example, fluid system 2700 enables each fluid line / catheter hub to be connected to each source fluid and / or sink before the procedure begins. When the interventional physician (or other medical practitioner) performing the procedure is ready to use a particular source fluid or sink, system 2700 is already configured and ready to allow the use of that 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 treatment method in which a fluid source does not need to be connected to and / or disconnected from a medical device multiple times during the procedure.

[0333] Thus, the interventional physician can inject any fluid contained in fluid sources 2710a, 2710b and / or collect aspirate from any of catheters 2726, 2728 and / or 2730 at any point during the procedure because each catheter hub 2724a, 2724b, 2724c always provides access to all fluid lines.

[0334] Because multiple sources indicated for a particular procedure are preconfigured to connect to each catheter / catheter hub, the interventionalist (or other medical personnel) can be assured that there is no repeated connection and disconnection of syringes or other source fluid containers, fluid lines, etc. during the procedure. This assurance eliminates the possibility of introducing air bubbles into the catheter flow during the procedure because no fluid sources need to be connected or disconnected using system 2700. Instead, each fluid source and tank is connected and tested before the procedure and not removed until after the procedure is completed. In some embodiments, the constant connection of the fluid sources and tanks to the catheter hub associated with the operation of system 2700 eliminates the variability and risk associated with remote surgery (where the interventionalist is in a control room rather than in the operating room).

[0335] The valves within the valve arrays 2716a, 2716b, and / or 2716c of the system 2700 are shown at the corresponding manifolds 2718a, 2718b, and 2718c. In this configuration, the valves are located near the corresponding 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 of the valve arrays 2716a, 2716b, and 2716c and the corresponding catheter hubs 2724a, 2724b, and 2724c. In some embodiments, the valves of the valve arrays 2716a, 2716b, and / or 2716c can alternatively be located at the source / sink (e.g., 2710a, 2710b, and / or 2712). In some embodiments, the valve arrays 2716a, 2716b, and / or 2716c are connected to the fluid line at a location between the source / sink and the hub. In some embodiments, valve arrays 2716a, 2716b, and / or 2716c can be located at the catheter hub 2724a, 2724b, and / or 2724c. In some embodiments, the valves located at or near the hub can be disposable valves. Other components of systems 2700, 2800 can also be disposable and / or reprocessable for reuse.

[0336] In some embodiments, the system 2800 can additionally include valves 2713a to 2713i between the valve arrays 2716a, 2716b, and 2716c and the corresponding hubs 2724a, 2724b, and 2724c. The valves 2713a to 2713c can be valve manifolds (e.g., such as Figure 26B 2713d to 2713f can be a valve manifold (e.g., such as a valve manifold 2616) that is part of or directly or indirectly connected to the hub 2724a. Figure 26B The valves 2713g to 2713i may be a valve manifold (e.g., such as a Figure 26B The valve manifold 2616 is a part of the hub 2724c or is directly or indirectly connected to the hub 2724c. The valves 2713a to 2713i can be one-way check valves. Figure 27 As shown, one-way check valves 2713a to 2713i can allow flow in the direction indicated by their respective arrows.

[0337] like Figure 28 As shown, each hub 2724a, 2724b, and 2724c can be provided with a hemostatic valve to accommodate the introduction of another device therethrough. The hemostatic valve comprises a variable diameter hole, such as a hole through an elastomeric gasket.

[0338] The gasket can be actuatable between a first fully open state for sealing injection of low-pressure fluid 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 the sink while allowing advancement or retraction of the interventional device; a second partially open state for preventing backflow of high-pressure fluid (e.g., contrast agent) from a second fluid source injected through the first port or for allowing fluid to flow through the first port to the sink; and a third tightly closed state. The gasket can be manually actuatable or automatically actuatable, for example, based on user input corresponding to manipulation of one or more interventional devices of the system.

[0339] Figure 28 Another embodiment of a fluid system 2800 for use with a fluid management system is shown. Typically, the fluid system 2800 includes two or more fluid channels that supply one or more fluid lines that are configured to interface with a rotary hemostatic valve. The two or more fluid channels can receive fluids having any number of fluid materials from a fluid source. The two or more fluid channels can allow different fluid materials provided by different fluid sources (having different volumes and / or at different pressures) to flow into or out of a body cavity. Each of the two or more fluid channels can be pre-filled with a corresponding fluid so as to be ready for delivery to a single fluid line and into the body. Valves and / or valve arrays can be used to switch between the use of the two or more fluid channels.

[0340] like Figure 28 As shown, the fluid system 2800 can include a vacuum chamber and / or controls 2802 within the sterile field. The vacuum chamber can have a clot filter with a window for visualizing trapped clots and a valved vent that allows air to enter when momentarily opened to allow direct visualization of the clot through the window. To allow for inspection by a remote physician, a CCD or CMOS sensor can be mounted so that the upstream surface of the clot filter is within the sensor's field of view. This allows the contents of the filter to be viewed on a remote monitor. An electronically actuated valve can be used to remotely control the intake of air to clear the optical path from the window to the filter.

[0341] A bubble filter 2804 can be disposed in the tubing between the needle injection port 2806 and the catheter 2826. The system 2800 also includes a tubing branch point 2808 (e.g., a Y-shaped object) in fluid communication with the first source 2810a and the second source 2810b. The tubing branch point 2808 can include a Luer lock connector or a Y-shaped connector that interfaces with multiple fluid sources.

[0342] The system 2800 may also include a pump, such as a peristaltic pump 2834 or a rotary piston pump, that drives fluid under pressure from the second source 2810b to the line branch point 2808 in the direction of arrow 2822c.

[0343] The bubble sensor can be provided on the upstream or downstream side of the pump 2834. The bubble sensors 2836a, 2836b can be non-contact ultrasonic sensors that measure the intensity and Doppler shift of reflected ultrasound passing through the sidewall of the fluid conduit to detect bubbles and measure the fluid flow rate or fluid level, as discussed above. In some embodiments, the sensor 2836a can also be a pressure sensor, or a separate pressure sensor can be provided.

[0344] A valve 2816c, such as a ball valve or rotary valve, can selectively open or close fluid communication between the second source 2810b and the conduit 2826. A flow rate detector, such as a drip rate sensor 2838, enables the flow rate from the second source 2810b to be determined and displayed.

[0345] Fluid flow from the first source 2810a is directed through a one-way check valve 2814 and to a high-pressure pump 2852, which can be a syringe pump, a high-pressure positive displacement pump, a contrast agent syringe pump, etc. The high-pressure fluid (e.g., a contrast agent solution) is directed through a bubble sensor 2836a and through valve 2816b to a branch point 2808. Arrow 2822B indicates the direction of fluid flow.

[0346] Based on available lumen cross-sectional area, the resistance of the fluid flow of the different conduits in the concentric conduit stack is different. For example, the resistance measurement value in the inner conduit with fully open lumen (for example, removing guide wire) may be lower than the resistance measurement value in the outer conduit with the second conduit (or guide wire) extending through it. Therefore, when performing the saline flushing step, fluid system 2800 can be configured to ensure that the flow rate by each inner conduit and outer conduit is similar or the flow rate is suitable for surgery, to avoid coagulation or other problems in the conduit. For this reason, a valve can be adjusted for each conduit to ensure that the flow rate remains constant in all conduits during the saline flushing. System 2800 can measure such flow rate in real time based on a flow rate sensor, and a control system can be configured to automatically adjust the valve settings and / or pump parameters to maintain the desired flow rate by each conduit.

[0347] In some embodiments, fluid resistance can be changed by regulating the insertion length of each shaft inserting its concentric adjacent lumen.As described herein, when the cross-sectional lumen area for flowing reduces, for example, when the second conduit (or guide wire) extends in the lumen, the fluid resistance in the lumen may be larger.The amount of fluid resistance can be subject to the influence of the length of cross section narrowing, for example, due to the placement of the second conduit (or guide wire) in the lumen. The second conduit (or guide wire) that partially extends through the lumen of the first conduit will provide a cross section narrowing of less length, and therefore, compared with the situation of the lumen of the first conduit that extends fully through the lumen of the first conduit with the second conduit (or guide wire), may cause lower fluid resistance in the lumen of the first conduit. Therefore, fluid resistance can be reduced by the depth of the insertion lumen (fluid is injected into this chamber) that partially retracts the second conduit (or guide wire).

[0348] System 2800 also includes a suction canister 2840 connected to the upstream side of a filter 2844. The downstream side of the filter 2844 is connected to a vacuum pump 2842. The suction canister 2840 is connected to a valve 2816a, which can communicate with a sterile field clot capture container 2802, which has been discussed elsewhere herein. Arrow 2822a indicates the direction of fluid flow.

[0349] An optional pressure sensor 2846 is depicted on the proximal end of the catheter 2826 or hub connected to a hemostasis valve, such as a rotary hemostasis valve (RHV) 2848.

[0350] In this example, the RHV 2848 is connected to two different fluid sources. The RHV 2848 may be comprised of a hub (e.g., Figure 2 124a) carries and is at least partially disposed in the hub. RHV 2848 may include a first fluid source connector, a second fluid source connector, and a tank connector. For example, the first connector, the second connector, and the third connector may include corresponding valves (e.g., valves 2816a, 2816b, and 2816c) connected to RHV 2848 via fluid lines. In some embodiments, the connection point may be formed as part of the RHV 2848 itself, and the fluid line may be directly connected to the connection point at the proximal end of the fluid line and connected to the source and / or tank at the corresponding distal end of the fluid line. In certain embodiments, valves 2816a, 2816b, and 2816c may be arranged in a valve manifold or a valve manifold box. In certain embodiments, pump 2834 may also be disposed in a valve manifold or a valve manifold box. In certain embodiments, any one of valves 2816a, 2816b, and 2816c may be a ball valve, a plug valve, a rotary valve, a solenoid valve, or any other suitable valve. Any of valves 2816a, 2816b, and 2816c may be controlled by one or more actuators 2817.

[0351] RHV 2848 can be configured to enable a catheter or other instrument to be introduced into a living being while preventing unintended backflow bleeding. In some embodiments, each RHV described herein can be configured to have at least a fully closed configuration, a low sealing force state in which a device can be advanced therethrough without leaking, and a high sealing force state (e.g., mode) in which fluid can escape at high pressure and can prevent axial movement of the device therethrough.

[0352] RHV 2848 is configured to simultaneously and fluidically connect to a first fluid source (e.g., source 2810a) via a first fluid source connection (e.g., valve 2816b). RHV 2848 is also configured to simultaneously and fluidically connect to a second fluid source (e.g., source 2810b) via a second fluid source connection (e.g., valve 2816c). Furthermore, RHV 2848 is also configured to simultaneously and fluidically connect to a sink (e.g., suction tank 2840) via a sink connection (e.g., valve 2816a).

[0353] In operation, system 2800 is configured to automatically switch between introducing fluid into the lumen of an elongated body (e.g., catheter 2826) from a first fluid source (e.g., source 2810a) or from a second fluid source (e.g., source 2810b) via RHV 2848, or is configured to allow fluid removed from the lumen to be collected in a tank (e.g., suction canister / tank 2840).

[0354] In some embodiments, the optional pressure sensor 2846 is located on the upstream or downstream side of the RHV 2848 (e.g., Figure 28 In some embodiments, an optional pressure sensor 2846 is located in the catheter (e.g., in the sidewall of the catheter) to measure arterial pressure at the distal end of the catheter. The pressure can be assessed by the interventional physician to confirm that the catheter is not misaligned within the vessel and / or thrombus.

[0355] For example, if the catheter is misaligned with the vessel wall, the detected pressure (e.g., waveform) can be attenuated. Such detection can be provided to an algorithm executed by a processor associated with the system 2800, for example, to determine the patency of the catheter lumen or the patency of the distal tip of the catheter. Such pressure sensors and algorithms can provide an improved alternative to traditional pressure measurements, in which there is manual manipulation of fluidics and the interventional physician may retract (e.g., pull back) a syringe connected to the catheter to confirm that blood capture has occurred and to evaluate tactile feedback from the catheter.

[0356] In some embodiments, the catheter lumen or distal tip can be assessed by pressure sensor 2846 to assess the openness of the catheter lumen or distal tip before injection or suction. However, pressure sensor 2846 can provide an automatic and improved way to assess the openness of the catheter lumen or distal tip. In other words, adding pressure sensor 2846 (e.g., a blood pressure sensor) on the proximal end of the catheter can capture arterial pressure waveforms. The waveform can be used to determine, without direct visual or tactile feedback, whether the catheter distal tip is pressed against the vessel wall, whether the catheter tip is pressed against the thrombus, whether the catheter tip has complete openness, or whether the catheter lumen is in a blocked or fully open state. In some embodiments, the waveform can be used to determine the engagement state of the catheter distal tip with the clot and / or the consistency of the clot.

[0357] In some embodiments, the fluid systems described herein (e.g., system 2700, system 2800) include a hemostatic valve (e.g., RHV 2848), which includes a first three-way connector having a first fluid source connector (e.g., one-way valves 2716a, 2816b), a second fluid source connector (e.g., one-way valves 2716b, 2816c), and a slot connector (e.g., one-way valve 2816a).

[0358] In some embodiments, the fluid systems described herein (e.g., system 2700, system 2800) utilize a first fluid source comprising one of saline, heparinized saline, or a drug. In some embodiments, the second fluid source (e.g., source 2710b, 2810b) comprises a contrast agent.

[0359] The systems 2700 and 2800 may also include a second hemostasis valve that is in communication with the second hub (e.g., 2724b) and may be at least partially disposed within the second hub. The second hemostasis valve may include a third fluid source connection (e.g., valve 2716b), a fourth fluid source connection (valve 2716b), and a second tank connection (e.g., valve 2716c). In this example, the first manifold 2718a may include a second output line that is configured to connect to the third fluid source connection (not shown). Figure 29Another embodiment of the fluid system 3100 used together with the fluid management system is shown. Typically, the fluid system 3100 includes a box that can connect multiple fluid sources and / or grooves to multiple interventional devices. Multiple fluid lines can extend between the source or groove and the box for connection to different interventional devices. For other sources and grooves, a single fluid line can extend between the source or groove and the box and can be separated within the box to be connected to different interventional devices. In certain embodiments, the box can include a connector array formed by connectors from multiple fluid sources and / or grooves for connection to a single interventional device (e.g., in rows or columns). Each connector array can be connected to a tubing set having a tube corresponding to each connector in the connector array.

[0360] The cassette 3141 can be a stand-alone assembly comprising a housing having a plurality of valves, tubing, and connectors, as described below. A first connector array comprises a plurality of releasable connectors, such as Luer connectors, for placing the cassette in fluid communication with complementary connectors that are in fluid communication with a suction source and at least one or two 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 or two or three interventional devices.

[0361] Thus, the cartridge 3141 forms a bridging module that, when assembled, is located between the various fluid and vacuum sources and the corresponding interventional devices.The cartridge 3141 may be configured for a single use, or may be resterilizable and reusable.

[0362] like Figure 29 As shown, system 3100 may include a first fluid source 3110a and a second fluid source 3110b. The fluid flow from the first source 3110a is directed through a one-way check valve 3114 and flows to a high-pressure pump 3152, which may be a syringe pump, a high-pressure positive displacement pump, a contrast agent syringe pump, etc. The fluid from the first fluid source 3110a may be a contrast agent solution, which is preferably injected under high pressure.

[0363] The fluid flow from the syringe pump is directed into the cassette 3141, which may include a plurality of valves, manifolds, and / or connectors. Within the cassette 3141, the fluid flow may be split along a plurality of branches 3118b to a plurality of connectors 3117b (e.g., Figure 29 The cassette may include four connectors 3117b (shown) for connecting to different interventional devices. The cassette may include a valve 3116b (e.g., a ball valve) with each branch 3118b upstream of the connector 3117b. In some embodiments, either valve 3116a or 3116b may be a ball valve, a plug valve, a rotary valve, a solenoid valve, or any other suitable valve.

[0364] Fluid flow from the second fluid source 3110b can be directed into a plurality of branches 3118c to a plurality of pumps 3134c (e.g., Figure 4 Four pumps 3134c are shown, such as peristaltic pumps or rotary piston pumps. 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 within the cassette 3141.

[0365] The system also includes a suction canister 3140 in communication with the upstream side of a filter 3144. The downstream side of the filter 3144 is in communication with a vacuum pump 3142. The suction canister receives fluid from a cartridge 3141, which includes a plurality of connectors 3117a, each configured to connect to a unique interventional device. A unique valve 3116a (at least two, and four in the example shown) can be located upstream of each connector 3117a. Each unique valve 3116a can be positioned along a branch 3118a.

[0366] In some embodiments, one or more connector arrays 3146 may be arranged, each connector array 3146 being configured to connect to an interventional device. Figure 29 Indicated by the dotted line. Figure 29 As shown, the connector array 3146 may include a connector 3117a, a connector 3117b, and a connector 3117c. Figure 29 As shown, array 3146 can be organized so that all connectors face the same direction in a common plane, such as in a linear row.

[0367] Connector array 3146 can be releasably connected to tubing set 3143, which includes a suction tube 3154, a first fluid tube 3155, and a second fluid tube 3156. In some embodiments, connectors 3117a, 3117b, and 3117c can be Luer lock connectors. Suction tube 3154 can be connected to connector 3117b of array 3146 via complementary connector 3117d for aspiration from the interventional device to the aspiration container. First fluid tube 3155 can be connected to connector 3117b of array 3146 via complementary connector 3117e to provide fluid flow from first fluid source 3110a to the interventional device. Second fluid tube 3156 can be connected to connector 3117c of array 3146 via complementary connector 3117f to provide fluid flow from second fluid source 3110b to the interventional device. Tubes 3154, 3155, and 3156 can be connected together over most of their lengths. Tubes 3154, 3155, and 3156 can each have a length of at least about 3 or 4 feet, and in certain embodiments, about 6 feet to about 8 feet.

[0368] like Figure 29 As shown, tubing set 3143 includes a line branch point 3100, which can provide fluid communication between the interventional device and tubes 3154, 3155, and 3156. Line branch point 3100 can include a Luer lock connector or a Y-shaped connector that connects to a complementary connector on the tubing set. In certain embodiments, a one-way valve 3145 can be located upstream of branch point 3108 and downstream of cassette 3141 along the flow path of the second fluid.

[0369] In certain embodiments, the system 3100 (or other systems described herein) can use two different flow modes to direct the flow of the second fluid (e.g., saline). In a low-flow trickle flow mode, a flow rate of approximately 1-2 drops / second or 3-6 mL / min can be provided, for example, by pump 3134. In some embodiments, a low-flow mode of 1-8 mL / min can be provided. Each catheter connected to the system may experience a different fluid resistance, as described herein.

[0370] In certain embodiments, the pump, such as pump 3134, can be operated to provide the same flow rate in each conduit. In certain embodiments, the fluid pressure in the conduit can be at least about 330 mmHg or 6.5 psi. This pressure can be enough to overcome arterial pressure while delivering the required drip rate. In certain embodiments, the pressure in the conduit can be greater than 330 mmHg. In certain embodiments, the volume of fluid delivered can be at least about 1 liter over the entire length of the operation. In some embodiments, the volume of fluid can be up to 2 liters.

[0371] In high-flow flush mode, all fluid lines can be flushed to remove air. The flow rate can be 100-1000 mL / min. The fluid pressure can be 5-10 psi. The volume delivered can be 0.5-1 liter per procedure. The volume can depend on the length and diameter of the tubing. In some embodiments, the high flush flow rate is at least about 20 times, and in some cases 30 to 150 times, the flow rate of the low-flow trickle mode.

[0372] In certain embodiments, the first fluid (e.g., contrast agent solution) can be provided, for example, by pump 3152, at a flow velocity of 3-8 mL / s (e.g., approximately 4 mL / s). In certain embodiments, the flow velocity can be up to approximately 8 mL / s. In other embodiments, the flow velocity can be up to approximately 20 mL / s. In certain embodiments, for a flow velocity of approximately 4 mL / s, the first fluid can be provided as a pressure with approximately 400 psi. Required pressure can depend on the flow restriction of flow velocity and fluid path. For higher flow velocity, pressure can increase proportionally with flow velocity. In certain embodiments, pressure can be up to 1200 psi.

[0373] In certain embodiments, a high-pressure pump (e.g., pump 3152) can provide a delivery volume of 5-15 mL per high-pressure injection. In certain embodiments, the pump can provide 5-15 mL per high-pressure injection in increments of approximately 1 mL per puff. In certain embodiments, the second fluid source can provide a total volume of approximately 200 mL per procedure. In certain embodiments, the syringe pump is sized to maintain at least approximately 150 mL or 200 mL to provide uninterrupted flow throughout the procedure without the need to add additional contrast solution. In other embodiments, the second fluid source can provide a total volume of 150-250 mL per procedure.

[0374] In certain embodiments, the flow rate can vary depending on the anatomical location at the distal end of the catheter. For example, within the aortic arch, the flow rate can be approximately 20 mL / s. A total delivered volume of approximately 25 mL can be infused into the aortic arch. Within the common carotid artery, the flow rate can be approximately 20 mL / s. A total delivered volume of 12 mL can be infused into the common carotid artery. Within the subclavian artery, the flow rate can be approximately 6 mL / s. A total delivered volume of approximately 15 mL can be infused into the subclavian artery. Within the internal carotid artery, the flow rate can be approximately 6 mL / s. A total delivered volume of approximately 8 mL can be infused into the internal carotid artery. Within the external carotid artery, the flow rate can be approximately 3 mL / s. A total delivered volume of approximately 6 mL can be infused into the external carotid artery. Within the vertebral artery, the flow rate can be approximately 6 mL / s. A total delivered volume of 8 mL can be infused into the vertebral artery.

[0375] In some embodiments, a motor can be provided to drive a high pressure pump, such as pump 3152, which can be controlled by a control loop (using a potentiometer as a measurement to close the loop) to control position and speed. In some embodiments, current control can be applied to provide approximate pressure limitation. In some embodiments, the second fluid can be a contrast agent solution, such as Omnipaque 300, Omnipaque 350, or Visipaque 320.

[0376] In certain embodiments, a vacuum pump, such as pump 3142, can provide a pressure of about -29.5 inHg or as much as -29.5 inHg (-999 mbar). In certain embodiments, the tubing for suction can have an inner diameter of 0.11 inches (about 2.8 mm). In certain embodiments, the volume of the suction container (such as container 3140) can be at least about 0.5 L. In certain embodiments, the volume of the suction container can include about 0.5 L for blood and an additional volume for saline flushing. In certain embodiments, the suction container can have a volume of 0.25-0.75 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 step, because it is desirable that the suction line is always filled with saline (except when suctioning clots). In certain embodiments, a separate pump can be provided for the low pressure / flow setting.

[0377] Figure 30 Certain aspects of an example of a portion of a robotic catheter system are shown, including an embodiment of a system 3200 for managing fluids. As further described below, in some embodiments, system 3200 can include a pump station 3202 and a cassette 3204. The cassette 3204 can include components and fluid communication pathways for a saline subsystem 3206, a contrast agent subsystem 3208, and a vacuum subsystem 3210. For example, the cassette 3204 can include connectors / ports for connecting to a tubing set, saline, contrast agent, and vacuum sources, one or more peristaltic pumps, one or more valves, one or more sensors, one or more contrast agent pumps, one or more vacuum canisters, one or more clot chambers, and fluid communication pathways for connecting saline, contrast agent, and vacuum sources to the hub and catheter. The pump station 3202 can include components that interact with the subsystems within the cassette when the cassette 3204 is connected to the pump station 3202. In an example, the pump station 3202 may include one or more valve actuators, one or more peristaltic pump drive mechanisms, and one or more contrast pump drive mechanisms configured to actuate and drive valves and pumps in the cassette as part of the saline, contrast, and vacuum subsystems. The pump station 3202 may also include one or more sensors configured to sense fluid flowing in certain fluid communication channels of the cassette 3204.

[0378] In some embodiments, the cassette 3204 and the pump station 3202 include corresponding electrical contacts or connectors (each referred to as "contacts") that are connected when the cassette 3204 is connected to the pump station 3202 to connect the electrical components (e.g., sensors) in the cassette 3204 to the pump station 3202. The electrical contacts may include contacts for providing information from the components in the cassette (or a hub connected to the cassette) to a controller in the pump station configured to operate the fluid system or a controller that communicates with the pump station, or to another system that utilizes such information. The electrical contacts may include contacts for providing energy to the components in the cassette. In some embodiments, the electrical contacts may also electrically connect the pump station 3202 to one or more hubs 3224 via the cassette 3204. Thus, the electrical contacts may provide energy to the components in the one or more hubs via the cassette (and via the electrical connectors between the cassette and the one or more hubs). Certain components of the system 3200 may be configured as disposable, and certain components may be configured as reusable. For example, one or more hubs 3224 and the catheters connected to the hubs, tubing sets 3216, and / or cassettes 3204 can be configured as disposable. For ease of reference, valves associated with controlling the provision of fluids and providing vacuum in the system 3200 may be collectively referred to as a "valve assembly." The valve assembly may include, but is not limited to, valves in the saline subsystem 3206, contrast subsystem 3208, and vacuum subsystem 3210 located in the pump station 3202, cassettes 3204, and / or one or more hubs 3224. As described in the examples below, the system 3200 provides saline, contrast agent, and vacuum (respectively) from saline, contrast agent, and vacuum sources to the one or more hubs 3224 and the catheters connected to the hubs 3224 via fluid communication channels. The fluid communication channels may include channels, tubes, ports, line connectors, and other structural components to communicate fluids and provide vacuum. Unless otherwise indicated, "channel," "tube," and "line" may be used synonymously herein to refer to fluid communication channels. For example, the fluid communication channels may include channels in the cartridge 3204, one or more tubes as part of the tubing set 3216, and tubes and / or channels located in the hub 3224, and the fluid communication channels may be collectively referred to as a fluid communication system.

[0379] exist Figure 31 、 Figure 32 and Figure 33 , embodiments of a saline subsystem 3206, a contrast agent subsystem 3208, and a vacuum subsystem 3210, respectively, that can be used to perform the method for controlling a fluid administration apparatus are shown. Figure 34 and Figure 35 An example of a configuration portion of a fluid system in relation to a hub is shown. Figure 36An example of a tubing set 3216 is shown that is connected to the box 3204 at one end and to one or more hubs 3224 and a femoral sheath 3226 at the other end. Figure 37 Certain components of a robotic catheter system are shown. These components are part of or associated with a fluid system, can be actuated by a controller or provide information to the controller, and the controller executes a method for controlling a fluid administration device by actuating such components and based (at least in part) on this information. The fluid subsystems and components can be controlled to perform fluid methods on the robotic catheter system, including, for example, priming the saline subsystem, priming the contrast agent subsystem, injecting contrast agent, aspirating clots, and flashing a hemostasis valve. These steps are at least partially controlled by a controller (e.g., system controller 3730). Valves, pumps, and other actuatable (or movable) components can be driven to a certain state or position by the controller. In some embodiments, the state or position of an actuatable component can be determined by a sensing mechanism on the component, allowing the controller to determine the current position of the component before, during, or after the procedure. In some examples, the sensing mechanism can include a switch, an encoder, etc. In some embodiments, the current state or position of a component can be electronically stored information (e.g., in a table or file), and the controller is configured to determine the position of one or more components by accessing this stored information. In an example, prior to injecting contrast agent using a selected catheter in a system having multiple catheters, a valve connecting the selected catheter to the contrast agent subsystem can be determined to be aligned in an open position to provide contrast agent to the selected catheter, and one or more valves connecting unselected catheters to the contrast agent subsystem can be determined to be aligned in a closed position to disconnect the unselected catheters from the contrast agent subsystem. This determination can be made using stored information or by using information from a sensing device. The steps described herein are examples of some steps that a controller can be configured to perform by automatically or semi-automatically controlling a fluidic device based on one or more user inputs, sensed information, and / or other information.

[0380] As mentioned above, in Figure 30 , an example of a fluid system 3200 is shown, which is configured to provide saline, contrast agent, and vacuum to one or more hubs 3224, and saline to a femoral sheath 3226. 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 to 3224c." Figure 30 As shown, a catheter is connected to each of the one or more hubs, and each of the hubs 3224a-3224c is configured to provide saline, contrast media, and vacuum (e.g., as shown in FIG. 32) from the fluid system 3200 to the lumen of the catheter connected to the hub. Figure 34 and Figure 35For ease of disclosure, providing saline, contrast media, or vacuum to the hub also refers to providing saline, contrast media, or vacuum to a catheter connected to the hub, unless the context indicates otherwise. Figure 30 An example of a multi-channel fluid system is provided that is configured to provide individually controllable amounts of saline, contrast, and vacuum to each of one or more hubs 3224a to 3224c and the femoral sheath 3226 as needed during a medical procedure. Because the catheters have different inner diameters, each catheter has a different sized lumen, and the amount of saline, contrast, and / or vacuum required during its use can vary based on the lumen size, it is advantageous to be able to separately control the saline, contrast, and vacuum for each hub. Each catheter can also have a different effective lumen size, which can change at certain times during a procedure based on the lumen containing another catheter or guidewire nested therein. It can also be advantageous to be able to separately control the saline, contrast, and vacuum for each hub because, during a medical procedure, a different amount of saline, contrast, or vacuum may be required at each catheter based on the use of the particular catheter. In other embodiments, such a fluid system can be configured as a one-way channel fluid system that provides controlled amounts of saline, contrast media, and vacuum to one hub, or as a multi-channel fluid system that provides controlled amounts of saline, contrast media, and vacuum to two hubs or four or more hubs.

[0381] In various embodiments, Figure 30 The fluid system 3200 shown can have similar or identical features to other fluid systems described herein. In this example, the fluid system 3200 includes a pump station 3202 and a cassette 3204 that is releasably connectable to the pump station. The pump station 3202 can include components that can be capital equipment. The cassette 3204 can include components that can be designed for single use, and the cassette is disposable. In an example of use, the cassette 3204 is a sterile, disposable component that is connected to the pump station 3202 before the procedure is performed, and the cassette 3204 is removed and disposed of after the procedure is completed. The fluid system 3200 can include multiple valves that control saline, contrast agent, or vacuum, located on the cassette, pump station, or hub (e.g., as Figures 30 to 35 、 Figure 373204 and may be collectively referred to as a valve assembly. In various embodiments, portions of the valve assembly may be located in the pump station 3202 or in the cartridge 3204. Various embodiments of the valve assembly may include additional valves, fewer valves, or different valves than those shown. The fluid system 3200 may also include sensors in the saline, contrast, and vacuum subsystems, and these sensors may be collectively referred to as a sensor assembly. In various embodiments, portions of the sensor assembly may be located in the pump station 3202 or in the cartridge 3204. Various embodiments of the sensor assembly may include additional sensors, fewer sensors, or different sensors than those shown.

[0382] In this example, fluid system 3200 includes a saline subsystem 3206, a contrast agent subsystem 3208, and a vacuum subsystem 3210. In some embodiments, vacuum subsystem 3210 can be a vacuum / aspiration ("V / A" or simply "vacuum") subsystem. Figure 31 An example of a brine subsystem 3206 is shown in FIG. Figure 32 An example of an embodiment of the contrast agent subsystem 3208 is shown in FIG. An example of an embodiment of the vacuum subsystem 3210 is shown in FIG. Figure 33 Shown in. Figure 31 、 Figure 32 and Figure 33 The illustrated embodiment may have additional components (e.g., valves, fluid channels / tubing, connectors, etc.) that are not shown for clarity of the drawing (e.g., check valves). In various embodiments, certain components of fluid system 3200 may be part of pump station 3202, and other components may be part of cassette 3204. For example, a portion of saline subsystem 3206 may be in cassette 3204, and a portion of the saline subsystem may be in pump station 3202. As a specific example, a portion of a peristaltic saline pump that controls the flow of saline may be in cassette 3204, and a drive mechanism component (e.g., actuator / drive motor, drive member) of the peristaltic saline pump may be in pump station 3202. When the cassette is connected to pump station 3202, the drive mechanism component connects to a portion of the peristaltic pump in the cassette, thereby controlling the drive mechanism component to control the flow of saline through the peristaltic pump. In another example, cassette 3204 may include a saline port to receive saline from a saline bag located outside the cassette, and a weight sensor that senses the weight of the saline bag may be part of the pump station.

[0383] Likewise, a contrast agent subsystem 3208, or a portion thereof, may be within the cassette 3204. For example, a contrast agent syringe pump, or a portion thereof, may be located within the cassette 3204, and the cassette 3204 may include a contrast agent port to receive contrast agent from a contrast agent container located external to the cassette 3204. The pump station 3202 may include an air column detector configured to detect air in a fluid communication channel (e.g., a tube) between the contrast agent container and the syringe pump.

[0384] In addition, the vacuum subsystem 3210 or a portion thereof may be included in the cassette 3204, and a portion of the vacuum subsystem may be included in the pump station. For example, the vacuum tank and vacuum control valve may be located in the cassette 3204, and the vacuum pump and actuator for the vacuum control valve may be located in the pump station 3202. As another example, the cassette 3204 may also include a vacuum port for connecting to a vacuum source at the pump station. Other configurations are possible in which certain components of the saline subsystem 3206, contrast agent subsystem 3208, and vacuum subsystem 3210 are located in the pump station 3202, and other components of the saline subsystem 3206, contrast agent subsystem 3208, and vacuum subsystem 3210 are located in the cassette 3204.

[0385] The saline, contrast, and vacuum ports are part of a fluid communication system that includes fluid communication channels (e.g., channels, tubes, lines, etc.) to connect the catheter to a saline source, a contrast source, and a vacuum source. The box 3204 includes portions of the fluid communication system that are connectable to the saline, contrast, and vacuum sources, and valves in the box that partially control the fluid flowing through the channels of the fluid communication system in the box. The fluid communication system also includes a tubing set 3216. The tubing set 3216 may include fluid communication channels for connecting saline, contrast, and / or vacuum to the hubs 3224a to 3224c and / or connecting saline to the femoral sheath 3226. In this example, the tubing set 3216 includes a saline tube 3218, a contrast tube 3219, and a vacuum tube 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' long. As Figure 30As shown in the embodiment of FIG, the saline subsystem 3206 includes a first connector array 3212a, a second connector array 3212b, and a third connector array 3212c, which represent locations for providing saline, contrast agent, or vacuum. 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 arranged in the second connector array 3214, and the tubing set 3216 can be connected to the second connector array 3214. The electrical channel 3217 can connect the first hub 3224a, the second hub 3224b, and the third hub 3224c to the cassette 3204 or to the pump station 3202, and can be used to provide control signals to the hub or receive information from the hub. Although the electrical channel 3217 is shown as a physical communication channel (e.g., comprising wires, cables, or optical fibers), in some embodiments where the electrical channel 3217 is configured to provide control signals to or information from the hubs 3224a to 3224c, the electrical channel 3217 can be a wireless communication channel.

[0386] Each of the hubs 3224a to 3224c (also referred to herein as a "hub assembly") can include a plurality of components associated with providing saline, contrast media, and vacuum to the catheter, as well as components associated with moving the hub and interventional devices connected thereto in an axial direction and rotating the catheter. The tubing group 3216 can also include electrical connectors to transmit control information to one or more hubs 3224 and / or receive information (e.g., sensor information) from components of the hubs 3224a to 3224c. The proximal end 3234 of the tubing group 3216 can be connected to the box 3204, and the distal end 3232 of the tubing group 3216 can be connected to the hubs 3224a to 3224c and the femoral sheath 3226. In the example shown, each of the hubs 3224a to 3224c is connected to the box 3204 via an electrical channel 3217, a saline tube 3218, a contrast media tube 3219, and a vacuum tube 3220. In Figure 34 An example of a fluid assembly in an embodiment of a hub is shown in FIG. In some embodiments, the hubs 3224a to 3224c may include additional components. For example, the hub may include components associated with connecting the interventional device to the hub, moving the hub and interventional device axially, and rotating the interventional device. An example of a tubing set 3216 is shown in FIG. Figure 36 Further shown in .

[0387] Figure 31 Shown are certain components and connections of an example of a saline subsystem 3206, which may be Figure 30The saline subsystem 3206 is shown. In this embodiment, the saline subsystem 3206 includes a saline weight sensor 3250 connected to a saline bag 3251. A contrast agent spike 3252 is used to pierce the saline bag 3251 and allow saline to flow through a saline tube 3253 into a saline chamber 3254. A vent 3255 in the chamber allows air to escape the saline chamber 3254 as the chamber fills. A chamber level detector 3256 is positioned to sense the saline level in the chamber. A line 3257 connects saline from the saline chamber 3254 to a saline manifold 3258. Four peristaltic pumps 3262a, 3262b, 3262c, 3262d (hereinafter referred to as "peristaltic pumps 3262a to 3262d") receive saline from the saline manifold 3258 via lines 3260a, 3260b, 3260c, 3260d (hereinafter referred to as "lines 3260a to 3260d"). Each peristaltic pump 3262a to 3262d is driven by an actuator 3263a, 3263b, 3263c, 3263d (hereinafter referred to as "actuators 3263a to 3263d"). Figure 31 In some embodiments of the examples shown in FIG, a peristaltic pump is located in the cassette 3204, and actuators 3263a to 3263d are located in the pump station 3202. When the peristaltic pumps 3262a to 3262d are driven by the actuators 3263a to 3263d, saline flows through lines 3264a, 3264b, 3264c, and 3264d, respectively (hereinafter referred to as "lines 3264a to 3264d") to ports S1 to S4, which can be located at a connector array that can be connected to the tubing set 3216.

[0388] In the illustrated embodiment, a saline / contrast valve 3266 is included in line 3264c. The saline / contrast valve 3266 can be moved to a second position or a first position by a saline / contrast valve actuator 3267, which can be in the pump station 3202. The saline / contrast valve 3266 is configured such that when it is placed in the first position ( Figure 31 ), the saline / contrast valve 3266 connects line 3264c to line 3270 to deliver saline from the peristaltic pump 3262c to the contrast manifold 3318 ( Figure 32 ), for priming the contrast agent subsystem 3208. When the saline / contrast agent valve 3266 is in the second position, the saline / contrast agent valve 3266 connects line 3264c to line 3268 and to port S3.

[0389] Figure 32Certain components and connections of an embodiment of a contrast agent subsystem 3208 are shown. In this embodiment, the contrast agent subsystem 3208 includes a contrast agent container 3302, a connection 3304 (e.g., a "contrast agent spike") for the contrast agent container, and a line 3305 connected to the connection 3304 and 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 connected to the contrast agent intake valve 3307 and is also connected 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, wherein the contrast agent intake valve 3307 is configured to open or close the fluid communication channel. The air column detector 3306 is positioned to detect air in the line 3305 and generate corresponding information (eg, a signal), which can be used by the system controller 3800 as input to perform steps.

[0390] The contrast agent pump 3310 includes a housing 3311 that encloses a contrast agent chamber 3313 that receives contrast agent from the contrast agent container 3302. The contrast agent pump 3310 includes a wall or movable portion 3312 that can be moved to increase or decrease the size of the contrast agent chamber 3313. The movable portion 3312 is connected to a movable member 3314 that can be moved by a linear contrast agent pump actuator 3315 that includes a motor. In some embodiments, the contrast agent intake valve actuator 3308, the contrast agent pump actuator 3315, and the air column detector 3306 (exhaustion sensor) can be located in the pump station 3202, and the contrast agent intake valve 3307 (between the connector 3304 and the contrast agent pump 3310), the contrast agent pump 3310, the contrast agent control valves 3322a, 3322b, 3322c (hereinafter referred to as "contrast agent control valves 3322a to 3322c"), and the lines and components that connect the contrast agent to ports C1, C2, C3 can be located in the box 3204, as shown. Figure 30 shown.

[0391] Contrast agent is provided from the contrast agent pump 3310 to the contrast agent manifold 3318 via line 3316. The contrast agent manifold 3318 provides fluid communication channels with contrast agent ports C1, C2, and C3 via lines 3320a, 3320b, 3320c (hereinafter referred to as "lines 3320a to 3320c"), contrast agent control valves 3322a to 3322c, and lines 3326a, 3326b, 3326c (hereinafter referred to as "lines 3326a to 3326c"). When the cassette 3204 is connected to the pump station 3202, contrast media valve actuators 3324a, 3324b, 3324c (hereinafter referred to as "actuators 3324a to 3324c") are connected to the contrast media control valves 3322a to 3322c and are controlled by the system controller 3800 to open and close the contrast media control valves 3322a to 3322c for performing a preparatory step (e.g., priming) or for performing a medical procedure (e.g., injecting contrast media). Line 3270 is a fluid communication channel connected to the saline subsystem 3206 connector and allows saline to flow from the saline subsystem 3206 to the contrast media manifold 3318 controlled by the saline / contrast media valve 3266.

[0392] Figure 33 An example of an embodiment of a vacuum subsystem 3210 is shown, which includes a vacuum source (vacuum pump 3388), a communication channel that can be aligned to provide vacuum from the vacuum source to the conduit, and components that control the provision of vacuum to the conduit. Various configurations of the vacuum subsystem may be capable of selectively providing vacuum to portions of the fluid system and the conduit at varying amounts of vacuum (e.g., at a first level (e.g., a lower level) and a second level (e.g., a higher level). Figure 33 In the illustrated embodiment, a vacuum pump 3388 is connected to lines 3385, 3389, and 3383, which provide access to a vacuum tank 3382. Specifically, in this example, the vacuum pump 3388 is connected to line 3385, which is connected to a vacuum regulator 3390, which can be controlled by a controller to provide a desired level of vacuum. Line 3389 is connected to the vacuum regulator 3390 and is also connected to a sterile filter 3386. Line 3383 is connected to the sterile filter and the vacuum tank 3382, which provides a reservoir for collecting aspirated material 3399. Line 3373 is also connected to the vacuum tank 3382 and to a vacuum manifold 3375, which is also connected to a channel that provides vacuum to multiple hubs / catheters of a robotic catheter system, such as, for example. Figure 34 and 35As shown. 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 a downstream vacuum subsystem (e.g., vacuum manifold 3375, ports V1 to V3, etc.). A vacuum pressure sensor 3371 can be located between the vacuum regulator valve 3377 and ports V1 to V3 to measure the vacuum provided to the hub and the catheter. In this example, the vacuum pressure sensor 3371 is located on line 3373 between the vacuum regulator valve 3377 and the clot chamber 3427b, which is located on line 3373 between the vacuum manifold 3375 and the vacuum regulator valve 3377 to receive clots aspirated by any of the multiple catheters connected to the vacuum subsystem 3210. In some embodiments, the clot chamber 3427 includes a clot chamber sensor 3432 that communicates with the controller to provide information about the contents of the clot chamber 3427 (e.g., when it contains clots). A flow sensor 3380 (eg, an ultrasonic flow sensor) is located between the clot chamber 3427 and the vacuum manifold 3375 to sense the flow of material through line 3373 and provide flow information to the controller.

[0393] The vacuum manifold 3375 can be connected to lines 3379a, 3379b, 3379c (hereinafter referred to as "lines 3379a to 3379c") and lines 3378a, 3378b, 3378c (hereinafter referred to as "lines 3378a to 3378c"), which provide vacuum channels to the hub / catheter through ports V1 to V3. The vacuum control valves 3374a, 3374b, 3374c (hereinafter referred to as "vacuum control valves 3374a to 3374c") can be one-way valves and are connected between pipelines 3379a to 3379c and pipelines 3378a to 3378c to control the supply of vacuum to ports V1 to V3, and the vacuum control valves 3374a to 3374c are opened and closed by the vacuum control valve actuators 3276a, 876b, 876c (hereinafter referred to as "vacuum control valve actuators 3276a-876c") of the pump station 3202, and the vacuum control valve actuators 3376a to 3376c are controlled by the controller. To provide vacuum to one or more ports V1 to V3 and the hubs and catheters connected to ports V1 to V3, the controller opens the vacuum control valves 3374a to 3374c corresponding to the desired ports, actuates the vacuum pump 3388, and controls the vacuum regulator 3390 and vacuum regulator valve 3377 to generate the desired vacuum and monitors the provided vacuum using the vacuum pressure sensor 3371. Some embodiments may include a flow sensor 3380 associated with each port V1 to V3 and / or a vacuum pressure sensor 3371 associated with each port V1 to V3. However, in most procedures, vacuum is provided to one catheter at a time, and in such cases, multiple flow sensors and pressure sensors do not provide any operational advantage, and as Figure 33 As shown, having a single flow sensor 3380 and a single vacuum pressure sensor 3371 located upstream of the vacuum manifold 3375 reduces costs. In some embodiments, the vacuum pump 3388, vacuum regulator 3390, vacuum control valve actuators 3276a to 3376c, and flow sensor 3380 are part of the pump station 3202, and the sterile filter 3386, vacuum canister 3382, vacuum regulator valve 3377, vacuum pressure sensor 3371, clot chamber 3427, and vacuum control valves 3374a to 3374c are located in the cartridge 3204.

[0394] Figure 34 An example of a catheter 3230 is shown connected to an embodiment of a tubing set 3216 in a hub 3410 of a fluid management system. A distal end 3232 of the tubing set 3216 is connected 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 part of a saline subsystem, all or part of a contrast agent subsystem, and / or all or part of a vacuum subsystem of the fluid management system. Figure 34 Certain components shown in the figure may be described as part of the tubing set 3216, even though they may be in the hub 3224 or in a portion of the sterile connector, because they operate to perform a portion of the fluid and vacuum communication functions 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.

[0395] like Figure 34 As shown, catheter 3430 can be connected to a portion of tubing set 3216 of the fluid management system via a Luer connector 3426. In this example, the portion of tubing set 3216 includes a contrast tube 3437 connected to port / connection point C1, a saline tube 3439 connected to port / connection point S1, and an aspiration tube 3435 connected to port / connection point V1. One or more electrical channels 3417 are connected to port / connection point E1, which can be on the cassette 3204 or on the pump station 3202. In some embodiments, electrical channels 3217 are part of tubing set 3216, such that tubing set 3216 includes tubes for connecting saline, contrast, and vacuum tubes from the cassette to the hub, as well as electrical connectors connected to the hub, and such embodiments can facilitate wire / tube management. The tubing set 3216 can include a branch point in the form of a two-to-one Y-connector 3420 that connects the upstream portions of the contrast media tube 3437 and saline tube 3439 of the tubing set 3216 to a single downstream saline / contrast media tube 3440. The tubing set 3216 can also include a three-way valve 3423 that can be actuated by a three-way valve actuator 3424 to selectively connect the catheter 3430 to the single downstream saline / contrast media tube 3440 or the aspiration tube 3435. In some embodiments, the tubing set 3216 can also include a catheter connector 3433 downstream of the three-way valve 3423 to connect the three-way valve 3423 to 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 3223. In some embodiments, the three-way valve actuator 3424 comprises an electromechanical means for moving the three-way valve 3423, which is controlled by a controller. In some embodiments, the three-way valve actuator 3424 comprises a motor controlled by a controller.

[0396] 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 the ports connected to the saline / contrast tube 3440, the suction tube 3435, and the catheter connecting tube 3433. The three-way valve 3423 can be actuated to a first position to open the fluid communication channel between the suction tube 3435 and the catheter connecting tube 3433, and can be actuated to a second position to open the fluid communication channel between the saline / contrast tube 3440 and the catheter connecting tube 3433. In some embodiments, the three-way valve 3423 can be actuated to a third position, wherein the suction tube 3435, the saline / contrast tube 3440, and the catheter connecting tube 3433 are all in fluid communication. In some embodiments, the three-way valve can be actuated to a fourth position, wherein the vacuum tube 3435 and the saline / contrast tube 3440 are in fluid communication. In some embodiments, the three-way valve 3423 can be actuated to a fifth position, wherein the aspiration tube 3435, the saline / contrast tube 3440, and the catheter connection tube 3433 are not in fluid communication.

[0397] Despite Figure 34 A three-way valve 3423 is shown in FIG, but other valve arrangements for selectively placing the catheter 3430 in communication with the saline / contrast tube 3440 or the aspiration tube 3435 may be used.

[0398] like Figure 34 As shown, the bubble filter 3422 can be located between the Y-shaped connector 3420 and the three-way valve 3423. In some embodiments, the clot compartment 3427 can be positioned along the aspiration tube 3435 upstream of the three-way valve 3423. The clot compartment sensor 3432 (in communication with the controller) can be positioned to detect material on the clot compartment 3427. In some embodiments, the clot compartment 3427 can be positioned in the hub 3224 along the aspiration tube 3435 upstream of the three-way valve 3423. In some embodiments, the Y-shaped connector 3420, the three-way valve 3423, the three-way valve actuator 3424, the clot compartment 3427a and / or portions of the tubing group can be housed in a magnetic sterile connector that can be connected to the hub 3224 (also referred to as a small circular element) and can be considered part of the hub assembly. In some embodiments, the clot compartment 3427b can be positioned. The clot chamber 3427a can be positioned along the aspiration tube 3435 near the vacuum canister 3282, such as between the vacuum manifold 3275 and the vacuum canister 3282. Figure 33 As shown in the implementation plan.

[0399] The hemodynamic pressure sensor 3429 may be located between the three-way valve 3423 and the catheter 3430, for example, on the catheter connecting tube 3433. The hemodynamic pressure sensor 3429 is configured to sense the hemodynamic pressure of the patient into which the catheter 3430 is inserted and provide information related to the sensed pressure to the controller. Figure 35 Another embodiment of components and fluid communication channels that can be connected to a hub and / or positioned in a hub is shown, and an example of another interventional device 3431 (e.g., a catheter, a guidewire) is also shown, which can be connected to another hub and positioned to extend through the hemostatic valve 3428 and at least partially into the lumen of the catheter 3430.

[0400] Figure 36 An example embodiment of a tubing set 3216 is shown, which can provide communication channels 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 connected to the first hub 3224a, the second hub 3224b, the third hub 3224c, and the femoral sheath 3226. Different portions of the proximal end 3234 are connected to the contrast, saline, vacuum, and electrical connections on the cassette. In this example, different portions of the proximal end 3234 are connected to the contrast ports (C1, C2, C3) of the contrast subsystem, the saline ports (S1, S2, S3, S4) of the saline subsystem, and the vacuum ports (V1, V2, V3) of the vacuum subsystem to provide fluid communication channels from the contrast, saline, and vacuum sources to the hubs, and to provide fluid communication channels from the saline subsystem to the femoral sheath. In this example, the tubing set 3216 also includes electrical communication channels that connect to the hubs 724a to 724c and connectors E1, E2, and E3 on the cassette 3204. The electrical communication channels can provide energy to the hub to operate components of the hub and / or can provide signals / information from the hub to the cassette, for example, from a hemodynamic sensor located in or on the hub. The cassette can include electrical connectors that connect to corresponding electrical connectors on the pump station when the cassette is connected to the pump station, so that the pump station can provide energy to the hub through the electrical communication channels of the cassette and tubing set and / or receive signals / information from the hub through the electrical communication channels of the tubing set and the cassette.

[0401] Figure 37 A schematic diagram of an example of a robotic catheter system is shown that includes a remotely positioned system ("remote system") and a locally positioned system (which may be referred to as a "local system," "bedside system," or "near-patient system"). According to some embodiments, Figure 37Also shown are examples of certain components of the local system, including certain components of a fluid management system ("fluid system"), including actuatable components actuated by a controller, and sensors that provide information to the controller for controlling the fluid system and other aspects of the robotic catheter system. A remote portion includes a control system 3710 that is remote from the patient. As used herein, "remote" is a broad term and generally refers to a location other than where the patient / local system is located when the patient undergoes a medical procedure using the robotic catheter system. For example, in a different room from the patient, in a different building, or in a different town, city, or country. In some embodiments, the remote portion is located hundreds or thousands of miles away from the local portion. Control system 3710 is configured to communicate with system controller 3800, which is part of the local portion of the system. System controller 3800 may include multiple controllers, each having one or more processors. In this example, system controller 3800 includes interface 3735. Interface 3735 may include multiple interfaces and may be a user interface. Interface 3735 can 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 fluidic actions (e.g., inject contrast agent from a catheter, provide suction from a catheter), or to move one or more hubs 3224 to move (axially or rotationally) one or more catheters or guidewires, and transmit corresponding signals to a controller (e.g., controller 3720 or pump station 3740). Interface 3735 can also be configured to receive control information (e.g., for fluidic actions or control hub movement) from a locally located user and connect to the interventional device, as well as to provide information (status, images, etc.) to the local user. Interface 3735 can include multiple interfaces. For example, one or more displays and display information related to 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, touch screen controls, etc.

[0402] The interface 3735 may also be configured to transmit information to the remotely located control system 3710. The transmitted information may relate to received control actions, fluid information, catheter position information, status information, images or video, audio, and other communications from the robotic system or a user located locally on the patient, as well as any other information that may be required to control the robotic catheter system from the control system 3710. The interface 3735 may also be configured to receive input from a user of the robotic catheter system located locally on the patient.

[0403] 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, and to process sensor information, and 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 agent, and vacuum to the hubs 3224a to 3224c as needed during the medical procedure, and providing saline to the femoral sheath.

[0404] Figure 37 The robotic catheter system shown in can include actuatable components of a fluid management system that are movable (e.g., controlled by a controller) to align fluid communication channels to provide saline, contrast agent, and vacuum from saline, contrast agent, and vacuum sources (respectively) to hubs 3224a to 3224c, and include certain sensors that are configured to sense conditions related to the provision of saline, contrast agent, and vacuum to hubs 3224a to 3224c and provide the sensed information to the controller. The controller can be configured to use the sensed information, user input, and / or stored information to control the action of the fluid system to perform a medical procedure. In various embodiments, the pump station 3740 can include a controller to control the actuators of the pump station 3740 to perform fluid-related actions (e.g., providing saline, contrast agent, and vacuum to hubs 3224a to 3224c). In other embodiments, the controller 3720 and / or the system controller 3800 can be configured to control the actuators and other components of the pump station 3740 to perform fluid-related actions. For clarity of illustration, in Figure 37 Many components and systems of the robotic catheter system are not shown (eg, hub axial drive system, check valves, catheter rotation system, controller for remote control system 3710, etc.).

[0405] A cassette configured to releasably attach to a pump station may include all or part of a saline subsystem 3206, a contrast agent subsystem 3208, and a vacuum subsystem 3210. The determination of disposable may 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 the pump station 3202 and its components are non-disposable (e.g., a fixture). In the example of the saline subsystem 3206, the pump station 3202 may include a saline weight sensor 3250 and a saline drip rate sensor 3259, peristaltic pump actuators 763a to 763d, and a saline / contrast valve actuator 3267, and the cassette 3204 may include a saline level detector 3245, peristaltic pumps 762a to 762d, and a saline / contrast valve 3266 ( Figure 15). In the example of the contrast agent subsystem 3208, the pump station 702 may include a contrast agent intake valve actuator 3308, a contrast agent pump actuator 3315, contrast agent valve actuators 3324a, 3324b, 824c, and an air column detector 3306, and the cassette 3204 may include contrast agent valves 822a to 822c, a contrast agent pump 3310, and a contrast agent intake valve 3307 (Figure 16). In the example of the vacuum subsystem 3210, the pump station 3202 may include a vacuum pump 3388, a vacuum regulator 3390, vacuum control valve actuators 3276a-876c, and a flow sensor 3280 (e.g., an ultrasonic flow sensor), and the cassette 3204 may include a vacuum regulator valve 3277, a vacuum pressure sensor 3271, a clot chamber sensor 3432, and vacuum control valves 3274a to 3274c. In various embodiments, the pump station 3202 and the cassette 3204 can include additional components or fewer components. Furthermore, in some embodiments, certain components shown and / or described herein as part of the cassette can be located in the pump station, and certain components shown and described herein as part of or supported by the cassette can be located in the pump station.

[0406] exist Figure 37 , the components shown in solid lines represent actuatable components and sensors, wherein the actuatable components can be controlled directly or indirectly by the controller and the sensors provide information to the controller. The components shown in dashed lines are not sensors and are not actuatable components (e.g., ports S1 to S4, C1 to C3, V1 to V3; saline chamber, vacuum tank, femoral sheath). In this embodiment, the actuatable components of the saline subsystem 3206 may include peristaltic pump actuators 3263a to 3263d and saline / contrast valve actuator 3267, which can be operated to move the saline / contrast valve 3266 ( Figure 31) is positioned in a first or second position to open or close the fluid communication channel between the saline subsystem 3206 and the contrast medium subsystem 3208; the sensors of the saline subsystem 3206 may include a saline weight sensor 3250, a saline level detector 3245 for detecting the sal...

Claims

1. A system for delivering a fluid to a target site in a patient's vasculature, the system comprising: a catheter comprising a tubular catheter shaft having a proximal end, a distal end, and a lumen defined by an inner surface of the catheter shaft, the lumen extending longitudinally through the catheter shaft between the proximal and distal ends; an introducing element having a distal end, a proximal end, and an outer surface, the introducing element being configured to be positioned within the lumen to create an area between the outer surface of the introducing element and the inner surface of the catheter, the area having an effective cross-sectional area for fluid communication of greater than or equal to approximately 0.001257 square inches, the system being configured to move the catheter and introducing element such that the distal end of the introducing element and the distal end of the catheter are advanced toward the target site while the introducing element is at least partially within the lumen of the catheter; and a contrast agent pump coupled to the catheter and in fluid communication with the lumen, the system being configured to actuate the contrast agent pump to provide contrast agent into the proximal end of the catheter at a pump pressure of less than or equal to approximately 400 psi while the guide element is at least partially positioned within the lumen of the catheter such that the provided contrast agent propagates along an outer surface of the guide element through the lumen of the catheter and out of the distal end of the catheter, wherein the effective cross-sectional area permits the contrast agent to flow out of the distal end of the catheter at a predetermined flow rate.

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

3. The system of claim 1, wherein the effective cross-sectional area is annular or eccentrically annular. The system of claim 1 , wherein the guiding element is a guide wire.

5. The system of claim 4, wherein the introducing element has a diameter of about 0.014 inches or about 0.020 inches, or the introducing element has a diameter of about 0.014 inches to about 0.020 inches.

6. 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 about 0.045 inches to 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 comprises a stainless steel wire braid reinforcement layer surrounding the lumen.

11. The system of claim 1 , wherein the catheter is a first catheter and the system further comprises a second catheter and a third catheter positioned so that the guide element, the first catheter, the second catheter, and the third catheter are concentrically arranged such that when the contrast agent is provided through the lumen of the first catheter, at least a portion of the guide element, the first catheter, and the second catheter are within the third catheter.

12. The system of claim 1, wherein the introducing element comprises a hydrophilic coating.

13. The system of claim 1, wherein the introducing element comprises a hydrophilic coating on a distal end thereof and a hydrophobic coating on a proximal end thereof, and wherein the hydrophobic coating comprises polytetrafluoroethylene.

14. A method of delivering a fluid to a target site in a patient's vasculature using a robotic catheter system, the method comprising: moving the distal end of the introducing element toward the target site; moving the distal end of the catheter to the target site while at least a portion of the introducing element is positioned within the lumen of the catheter; and A contrast agent is provided into the proximal end of the catheter at a pressure of less than or equal to about 400 psi while at least a portion of the guide element is positioned within the lumen of the catheter such that the provided contrast agent propagates along the outer surface of the guide element, through the lumen, and out the distal end of the catheter, wherein the lumen and the guide element are sized to create an effective cross-sectional area greater than or equal to about 0.001257 square inches between the outer surface of the guide element and the inner surface of the catheter and to provide a predetermined flow rate of the contrast agent out of the distal end of the catheter.

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

16. The method of claim 14, wherein the effective cross-sectional area is annular or eccentrically annular.

17. The method of claim 14, wherein the introducing element has a diameter of about 0.014 inches or about 0.020 inches, or the introducing element has a diameter of about 0.014 inches to about 0.020 inches, and 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 about 0.045 inches to about 0.049 inches.

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

19. A method as claimed in claim 14, wherein the catheter is a first catheter and a second catheter and a third catheter, and the second catheter and the third catheter are positioned so that the guide element, the first catheter, the second catheter and the third catheter are arranged concentrically so that when the contrast agent is provided through the lumen of the first catheter, at least a portion of the guide element, the first catheter and the second catheter are within the third catheter.

20. The method of claim 14, wherein the guide element is connected to a first hub and the catheter is connected to a second hub, and wherein the first hub is magnetically connected to a first pulley of a drive assembly through a sterile barrier and the second hub is magnetically connected to a second pulley of the drive assembly through the sterile barrier, and moving the distal end of the guide element and the distal end of the catheter includes moving the first pulley and moving the second pulley.

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