Sterile Packaging Assembly for Robotic Interventional Devices

Abstract

A sterile packaging assembly for transporting an interventional device to a robotic surgical site includes: a sterile barrier having a hub support portion and configured to enclose a sterile volume; and at least a first interventional device within the sterile volume. The first interventional device includes a hub and an elongated flexible body. The hub includes at least one magnet and at least one roller, the at least one roller configured to roll over the hub support portion of the sterile barrier.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Patent Application No. 17 / 527,460, filed November 16, 2021, and U.S. Provisional Application No. 63 / 232,444, filed August 12, 2021, the entireties of each of which are incorporated by reference herein. [Background technology]

[0002] A variety of neurovascular procedures, including thrombectomy, diagnostic angiography, embolization coil placement, and stent placement, can be accomplished via transvascular access. However, delivery of neurovascular care is limited or delayed by a variety of challenges. For example, there are not enough trained interventionalists and centers to meet the current demands for neurointerventions. Neurointerventions are challenging, with complex set-up requirements and demands on the surgeon's dexterity. With both hands, the surgeon must exercise precise control over three to four coaxial catheters, as well as manage the fluoroscopy system and patient position. The long tortuous anatomy requires delicate and precise maneuvering. Inadvertent catheter movement can occur due to frictional interactions between the coaxial shafts and the patient's vasculature. The supra-aortic access required to reach the neurovasculature is difficult to achieve (especially the type III arch).

[0003] Thus, a need remains for a supra-aortic access system that addresses some or all of these challenges and increases the availability of neurovascular procedures. Preferably, the system would additionally be capable of driving devices further distally through the supra-aortic access to achieve procedures in the intracranial vessels. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent Application Serial No. 63 / 256,743 Summary of the Invention [Means for solving the problem]

[0005] According to one aspect of the present invention, a supra-aortic access robotic control system is provided. The system includes a guidewire hub configured to adjust the axial and rotational positions of a guidewire; a guide catheter hub configured to axially adjust a guide catheter; and an access catheter hub configured to adjust the axial and rotational positions of the access catheter and configured to laterally deflect a distal deflection zone of the access catheter. The guidewire hub can additionally be configured to laterally deflect a distal portion of the guidewire.

[0006] A procedure catheter hub configured to manipulate the procedure catheter can also be provided. Following robotic placement of the guidewire, access catheter, and guide catheter such that the guide catheter provides supra-aortic access, the guidewire and access catheter can be withdrawn proximally and the procedure catheter can be advanced through and beyond the guide catheter to reach the neurovascular treatment site. The procedure catheter can be an aspiration catheter; an embolization catheter; a stent placement catheter; a flow diverter placement catheter; an access catheter; a diagnostic angiography catheter; a guiding catheter, an imaging catheter, a physiological sensing / measurement catheter, an infusion or injection catheter, a balloon catheter, or a stent retriever.

[0007] The control system may further include a driven magnet on each of the guidewire hub, the access catheter hub, and the guide catheter hub, the driven magnet configured to cooperate with a corresponding drive magnet such that the driven magnet moves in response to movement of the corresponding drive magnet. The drive magnets may each be independently axially movably carried by the support table. The drive magnets may be positioned outside the sterile field and separated from the driven magnet by a barrier, and the driven magnet may be within the sterile field. The barrier may include a tray made of a thin polymer film or any film of non-ferromagnetic material.

[0008] The control system may further include a control console, which may be connected to the support table or may be located remotely from the support table, and the position of each driven magnet and corresponding hub is movable in response to manual manipulation of a guidewire drive control, an access catheter drive control, or a treatment catheter drive control on the console.

[0009] The control system can further include a processor for controlling the position of the drive magnet. The processor can be in wired communication with the control console or in wireless communication with the control console. The driven magnet can be configured to remain engaged with the corresponding drive magnet until application of a splitting force of at least about 300 grams.

[0010] Also provided is a robotically driven interventional device. The device includes an elongated flexible body having a proximal end and a distal end. A hub is provided at the proximal end. At least one rotatable roller is provided on a first surface of the hub, and at least one magnet is provided on the first surface of the hub. The roller can extend further from the first surface than the magnet. The hub can further include at least a second roller.

[0011] Any of the guidewire hub, access catheter hub, and procedure catheter hub may further be provided with a rotational drive for rotating the corresponding interventional device relative to the hub. The hub may further be provided with an axial drive mechanism for distally advancing or proximally retracting a control element extending axially through the interventional device to adjust attributes such as the shape or flexibility of the interventional device. The control element may be an axially movable tubular body or wire (e.g., a pull wire extending through the interventional device, e.g., to a distal deflection zone).

[0012] Also provided is a control system for controlling movement of an interventional device. In one configuration, the control system includes a guidewire control configured to control the axial travel and rotation of a guidewire; an access catheter control configured to control the axial and rotational movement of an access catheter; and a guide catheter control configured to control the axial movement of a guide catheter.

[0013] The control system may further include a deflection control configured to control deflection of the access catheter, and may be configured for wired or wireless communication with the robotic catheter drive system.

[0014] The control system can be configured to independently control three or more hubs in various modes. For example, two or more hubs can be selectively ganged together such that they drive each device simultaneously and with the same motion. Alternatively, the control system can be configured to drive each device simultaneously but with different motions.

[0015] The control system may further include a physician interface for operating the control system. The physician interface may be carried by a support table having a robotic interventional device drive system. Alternatively, the physician interface for operating the control system may be carried on a portable handheld device or desktop computer and may be located in the same room as the patient, in the same facility as the patient, or in a remote facility.

[0016] The control system may further include a graphical user interface with at least one display for indicating the status of at least one device parameter and / or for indicating the status of at least one patient parameter.

[0017] Also provided is a sterile packaging assembly for transporting an interventional device to a robotic surgical site. The packaging assembly can include a base and a sterile barrier configured to enclose a sterile volume. At least one interventional device can be disposed within the sterile volume, the device including a hub and an elongated flexible body. The hub can include at least one magnet and at least one roller configured to roll on the base.

[0018] In one implementation, the sterile barrier is removably attached to the base and defines an enclosed volume between the sterile barrier and the base. In another implementation, the sterile barrier is in the form of a tubular enclosure for enclosing the sterile volume. The tubular enclosure can enclose the base and at least one interventional device, which are within the sterile volume.

[0019] The hub can be oriented in the packaging such that the rollers and magnets face the base. Alternatively, the base can be in the form of a tray having an elongated central axis. The upper sterile field side of the tray can have an elongated support surface for supporting and enabling sliding movement of the hub or hubs. At least one and optionally two elongated trays can be provided extending parallel to the central axis. At least one hub and an interventional device can be provided in the tray, and the sterile tray with the sterile hub and interventional device can be positioned in a sterile volume defined by a sterile barrier.

[0020] The base can be configured to reside on a support table adjacent to a patient, with an upper surface of the base within the sterile field and a lower surface of the base outside the sterile field.

[0021] Any of the hubs disclosed herein can further include a fluid injection port and / or a wireless RF transceiver. The hub can include a visual indicator to indicate the presence of a clot. The visual indicator can include a clot chamber having a transparent window. A filter can be provided within the clot chamber.

[0022] Any of the hubs disclosed herein can further include a sensor for detecting a parameter of interest (e.g., the presence of a blood clot, etc.). In some cases, the sensor can be positioned on the flexible body. The sensor can include a pressure sensor or an optical sensor. In some embodiments, the sensor can include one or more of a force sensor, a temperature sensor, and / or an oxygen sensor. In some embodiments, the sensor can include a fiber Bragg grating sensor. For example, a fiber Bragg grating sensor (e.g., fiber optic) can locally detect strain that can facilitate detection and / or determination of the applied force. The device can further include multiple sensors. The multiple sensors can each include one or more of any type of sensor disclosed herein. In some embodiments, multiple (e.g., three or more) sensors (e.g., fiber Bragg grating sensors) can be distributed around the perimeter to facilitate detection and / or determination of shape. In some cases, the location of the device can be determined through the use of one or more sensors to detect and / or determine the location. For example, one or more optical encoders can be positioned in or adjacent to one or more motors that drive linear motion such that the optical encoders can determine position.

[0023] Also provided is a method of performing a neurovascular procedure, where a first phase includes robotically achieving supra-aortic access and a second phase includes manually or robotically performing the neurovascular procedure via the supra-aortic access. The method includes providing an access catheter having an access catheter hub; coupling the access catheter hub to a hub adapter movably carried by a support table; and driving the access catheter in response to movement of the hub adapter along the table until the access catheter is positioned to achieve supra-aortic access. The access catheter and access catheter hub can then be released from the hub adapter, and a procedure catheter hub with a procedure catheter can then be coupled to the hub adapter.

[0024] The method may additionally include advancing the procedural catheter hub to position a distal end of the procedural catheter at the neurovascular treatment site. Driving the access catheter may include driving the access catheter distally through the guide catheter. Driving the access catheter may include laterally deflecting a distal region of the access catheter to achieve supra-aortic access.

[0025] Also provided is a method of performing a neurovascular procedure, the method including providing an access assembly including a guidewire, an access catheter, and a guide catheter. The access assembly can be releasably coupled to a robotic drive system. The access assembly can be driven by the robotic drive system to provide access to a desired point, such as to provide supra-aortic access. The guidewire and access catheter can then be released from the access assembly, leaving the guide catheter in place. A procedure assembly can be provided including at least the guidewire and a first procedure catheter. The procedure assembly can be releasably coupled to the robotic drive system, and the neurovascular procedure can be accomplished using the procedure assembly. A second procedure catheter can also be provided to extend through the first procedure catheter to a treatment site.

[0026] The step of coupling the access assembly can include magnetically coupling a hub on each of the guidewire, the access catheter, and the guide catheter to a separate corresponding coupler carrying a corresponding drive magnet independently movably carried by the drive table. The procedure assembly can include a guidewire, a first catheter, and a second catheter. The guidewire and the first catheter can be concentrically positioned within the second catheter. The procedure assembly can be advanced as a unit through at least a portion of the length of the guide catheter, and the procedure can include a neurovascular thrombectomy.

[0027] Additional features and advantages of the present invention are disclosed in Appendices A and B to US Provisional Application No. 63 / 232,444, each of which is incorporated herein by reference in its entirety. [Brief description of the drawings]

[0028] [Figure 1] FIG. 1 is a schematic perspective view of an interventional setup having an imaging system, a patient support table, and a robotic drive system according to the present invention. [Diagram 2] FIG. 1 is a longitudinal cross-sectional view showing the concentric relationship between a guidewire having two degrees of freedom, an access catheter having three degrees of freedom, and a guide catheter having one degree of freedom. [Figure 3A] FIG. 13 is an exploded schematic view of the interventional device hub separated from the support table by a sterile barrier. [Figure 3B] FIG. 13 shows an alternative sterility barrier in the form of a shipping tray having one or more storage channels for carrying interventional devices. [Figure 3C] FIG. 13 shows an alternative sterility barrier in the form of a shipping tray having one or more storage channels for carrying interventional devices. [Figure 3D] FIG. 13 shows an alternative sterility barrier in the form of a shipping tray having one or more storage channels for carrying interventional devices. [Figure 3E] FIG. 13 shows an alternative sterility barrier in the form of a shipping tray having one or more storage channels for carrying interventional devices. [Figure 3F] FIG. 13 shows an alternative sterility barrier in the form of a shipping tray having one or more storage channels for carrying interventional devices. [Figure 4] FIG. 1 is a schematic elevational cross-section through a hub adapter having a drive magnet separated from an interventional device hub and driven magnet by a sterile barrier. [Figure 5A] FIG. 1 is a schematic diagram illustrating three interventional device assemblies. [Figure 5B] FIG. 1 is a schematic illustration of four interventional device assemblies. [Figure 6] FIG. [Figure 7] FIG. 13 is a close-up view of the motorized end of the support table. [Figure 8] FIG. 2 is an elevational section through the motor and belt drive assembly. [Figure 9] FIG. 2 is a close-up view of the pulley end of the support table. [Figure 10] FIG. 2 is an elevational cross-sectional view through a belt pulley. [Figure 11] FIG. 5C is a side elevational cross-sectional view through a distal portion of a catheter such as, for example, either of those shown in FIGS. 5A and 5B. [Figure 12A] FIG. 13A is a schematic illustrating a force sensor integrated into the sidewall of a catheter. [Figure 12B] FIG. 13A is a schematic illustrating a force sensor integrated into the sidewall of a catheter. [Figure 13A] FIG. 13 is a schematic diagram illustrating a sensor for measuring elastic forces in a magnetic coupling between a hub and a corresponding carriage. [Figure 13B] FIG. 13 is a schematic diagram illustrating a sensor for measuring elastic forces in a magnetic coupling between a hub and a corresponding carriage. [Figure 14] FIG. 13A and FIG. 13B are schematic diagrams illustrating a dual encoder torque sensor for use with the catheter of the present invention. [Figure 15] FIG. 1 illustrates a clot capture and visualization device that may be integrated into the hub and / or connected to a suction line. [Figure 16] 1A-1C are schematic diagrams illustrating embodiments of mechanical couplings between a driving mechanism and a driven mechanism. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] The present invention provides a system for advancing a guide catheter from femoral or radial access into the ostium of one of the great vessels at the apex of the aortic arch, thereby achieving supra-aortic access. The surgeon can then take over and advance an interventional device into the cerebral vasculature via the robotically placed guide catheter.

[0030] In some implementations of the present invention, the system can be additionally configured to robotically obtain intracranial vascular access and perform aspiration thrombectomy or other neurovascular procedures. It will be understood by those skilled in the art that the functionality of the system of any embodiment as described herein is not limited to the application of the system to a patient. Any system described herein can be utilized in any application requiring manipulation of various tubular bodies relative to one another (e.g., medical or non-medical procedures, etc.). Thus, it should be understood that the application of any embodiment described herein is not limited to procedures for medical treatment.

[0031] The drive table is positioned on or near 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. Each device has a proximal end attached to a unique hub, sometimes referred to as a "puck." The hub is movable along a path along the surface of the drive table to advance or retract the interventional device as desired. Each hub may also include a mechanism for rotating or deflecting the device as desired, and is connected to a fluid delivery tube (not shown) of the type conventionally attached to a catheter hub. Each hub is in electrical communication with an electronic control system via either a hardwired connection, an RF wireless connection, or a combination of both.

[0032] Each hub is independently movable across a surface of a sterile field barrier membrane carried by a drive table. Each hub is releasably coupled to a unique drive carriage on the table side of the sterile field barrier. In some embodiments, each hub can be releasably coupled to a unique drive carriage through a magnetic and / or mechanical coupling system. The drive system independently moves each hub proximally or distally across the surface of the barrier to move a corresponding interventional device proximally or distally within the patient's vasculature.

[0033] The carriage on the drive table that magnetically and / or mechanically couples with the hub to provide linear motion actuation is universal. Catheter / guidewire functionality is provided based on what is contained within the hub and the shaft design. This allows flexibility to configure the system to perform a wide range of procedures using a wide variety of interventional devices on the same drive table.

[0034] 1 is a schematic perspective view of an interventional setup 10 having a patient support table 12 for supporting a patient 14. An imaging system 16 can be provided along with a robotic interventional device drive system 18 according to the present invention.

[0035] Drive system 18 can include, for example, a support table 20 for supporting a guidewire hub 26, an access catheter hub 28, and a guide catheter hub 30. In this context, the term "access" catheter can be any catheter having a lumen with at least one distally or laterally facing distal opening that can be utilized to aspirate thrombus, to provide access for additional devices to be advanced through or along it, or to inject saline or contrast or therapeutic agents.

[0036] More or fewer interventional device hubs may be provided depending on the desired clinical procedure. A plurality of interventional devices 22 extend between the support table 20 and (in the illustrated example) a femoral access point 24 on the patient 14. Depending on the desired procedure, access may be achieved by percutaneous or cut-down access to any of the various arteries or veins (e.g., femoral or radial arteries, etc.). Although disclosed herein primarily in the context of neurovascular access and procedures, the robotic drive system and associated interventional devices may be readily configured for use in a wide variety of additional medical interventions in the peripheral and coronary and venous vasculature, the gastrointestinal system, the pulmonary airways, treatment sites reached via transureteral or urethral or tubal navigation, or other hollow organs or structures within the body.

[0037] For example, a display 23 for viewing fluoroscopic images, catheter data (e.g., fiber Bragg grating fiber optic sensor data or other force or shape sensing data), or other patient data, etc. may be carried by the support table 20 and / or the patient support 12. Alternatively, the physician input / output interface including the display 23 may be remote from the patient, e.g., behind radiation shielding, in a different room than the patient, or in a different facility than the patient.

[0038] In the illustrated example, a guidewire hub 26 is carried by the support table 20 and is movable along the table for advancing 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 for advancing 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 manipulation of a rotation control, and can also be configured to laterally deflect a deflectable portion of the access catheter in response to manipulation of a deflection control.

[0039] FIG. 2 is a longitudinal cross-sectional view illustrating generally the kinematic relationships between a guidewire 27 having two degrees of freedom (axial and rotational), an access catheter 29 having three degrees of freedom (axial, rotational, and lateral deflection), and a guide catheter 31 having one degree of freedom (axial).

[0040] 3A, the support table 20 includes drive mechanisms, described in more detail below, for independently driving the guidewire hub 26, the access catheter hub 28, and the guide catheter hub 30. To resist buckling of the portion of the interventional device spanning the distance between the support table 20 and the femoral artery access point 24, an anti-buckling feature 34 can be provided in a proximal anti-buckling zone. The anti-buckling feature 34 can include a plurality of concentric, telescopically axially extendable and collapsible tubes through which the interventional device extends.

[0041] Alternatively, one or more proximal segments of the device shaft can be configured with enhanced stiffness to reduce buckling under compression. For example, the reinforced proximal segment can extend distally from the hub for a distance of at least about 5 cm or 10 cm, but typically no more than about 130 cm or about 100 cm or about 50 cm or about 30 cm, to support the device between the hub and the access point 24 on the patient. Reinforcement can be achieved by embedding at least one or two or more axially extending elements (e.g., elongated wires or ribbons, etc.) into the wall. Alternatively, a thin tubular stiffening structure can be embedded in the device wall or carried over the outside of the device wall (e.g., a length of tubular polymer extrusion or hypotube, etc.). Alternatively, a removable stiffening mandrel can be placed in a lumen in the proximal segment of the device and removed proximally following distal advancement of the hub towards the patient access site to prevent buckling of the proximal shaft during distal advancement of the hub. Alternatively, the wall thickness or diameter of the interventional device can be increased in the anti-buckling zone.

[0042] The interventional device hub can be separated from the support table 20 by a sterile barrier 32. The sterile barrier 32 can include a thin plastic film such as PET or the like. This allows the support table 20 and associated drive systems to reside on the non-sterile (lower) side of the sterile barrier 32. The guidewire hub 26, the access catheter hub 28, the guide catheter hub 30, and the associated interventional devices are all on the sterile (upper) side of the sterile barrier 32. The sterile barrier is preferably waterproof and can also serve as a tray used in packaging the interventional devices (discussed further below). The interventional devices can be provided individually or as a coaxially pre-assembled kit, which is shipped and stored in the tray and enclosed in sterile packaging.

[0043] 3B-3F illustrate generally an alternative sterility barrier in the form of a dual-function sterility barrier for placement on a support table during an interventional procedure and in the form of a shipping tray having one or more storage channels for carrying sterile interventional devices.

[0044] 3B and 3C, a sterility barrier 32 is shown in the form of a pre-shaped tray to fit over the elongated support table 20. The sterility barrier 32 extends between a proximal end 100 and a distal end 102 and includes an upper support surface 104 for supporting an interventional device hub. In one implementation, the support surface 104 has an axial length greater than the length of the intended interventional device in a linear drive configuration. The length of the support surface 104 will typically be at least about 150 cm or about 180 cm in a linear drive table. A shorter length can be utilized in a system configured to advance a drive coupler along an arcuate path.

[0045] At least a first channel 106 can be provided that extends axially at least a portion of the length of the support table 20. In the illustrated implementation, the first channel 106 extends the entire length of the support table 20. Preferably, the first channel 106 has a length sufficient to hold an interventional device, and a width and depth sufficient to hold a corresponding hub. The first channel 106 is defined in the floor 108, the outer wall 110, and the inner wall 111, forming an upwardly facing concave surface. Optionally, a second channel 112 can be provided. The second channel 112 can be located on the same or opposite side of the upper support surface 104 from the first channel 106. Two or three or more additional recesses (e.g., additional channels or wells, etc.) can be provided to hold additional medical devices or medical supplies that may be useful during an intervention procedure.

[0046] 3D, guide catheter hub 30 is shown positioned on upper support surface 104 and magnetically coupled to a corresponding coupler holding a drive magnet positioned below sterile barrier 32. It will be understood by one of ordinary skill in the art that in any of the embodiments described herein, any hub as described herein can be mechanically coupled to a corresponding coupler through sterile barrier 32 as an alternative or in addition to a magnetic coupling mechanism. Access catheter hub 28 and access catheter 29, as well as guidewire hub 26 and guidewire 27 are shown, which are present in first channel 106, e.g., prior to introduction through guide catheter 31 or following removal from guide catheter 31. Lengths of the catheters have been cut off to simplify the drawing.

[0047] The interventional device can be positioned in the channel 106 for shipment and enclosed within a sterile barrier. The sterile barrier including the sterile interventional device can be contained within a sealed second outer container (e.g., a membrane pouch, etc.), which can be the second outer sterile barrier. At the clinical site, the upper panel of the sterile barrier can be removed, or the outer tubular sterile barrier packaging can be opened and axially removed from the support table 20 and sterile barrier 32 assembly, exposing the sterile upper side of the sterile barrier tray and any contained interventional device. The interventional device can be carried separately in the channel or can be preassembled into an access assembly or a procedure assembly (discussed in additional detail below).

[0048] 3D-3F illustrate the support table with the sterile barrier in place, and in FIG. 3E the interventional device is configured with an access assembly for aortic access, following connection of the access assembly to a corresponding carriage below the sterile barrier. The access assembly can be pre-assembled with the guidewire fully advanced through the access catheter, which in turn is fully advanced through the guide catheter. This access assembly can be lifted out of the channel 106 as a unit and positioned on the support surface 104 for connection to the respective drive magnets and for introduction into the patient. The guide catheter hub 30 is the most distal hub. The access catheter hub 28 is positioned proximally of the guide catheter hub to allow the access catheter 29 to extend distally through the guide catheter. The guidewire hub 26 is positioned most proximally to allow the guidewire 27 to be advanced through the access catheter 29 and the guide catheter 31.

[0049] The procedure assembly is illustrated in FIG. 3F following its introduction through the guide catheter 31 used to achieve supra-aortic access. In this implementation, the guide catheter 31 remains the most distal of the interventional devices. A first procedure catheter 120 and corresponding hub 122 are illustrated extending through the guide catheter 31. An optional second procedure catheter 124 and corresponding hub 126 are illustrated extending through the first procedure catheter 120. The guidewire 27 extends through at least a portion of the second procedure catheter 124 in a rapid exchange version of the second procedure catheter 124, or through the entire length of the second procedure catheter 124 in an over-the-wire implementation.

[0050] In one commercial implementation, a pre-assembled access assembly (guide catheter, access catheter, and guidewire) can be carried in a first channel on the sterile barrier tray, and a pre-assembled procedure assembly (one or two procedure catheters and guidewire) can be carried in the same or different second channel on the sterile barrier tray. One or two or more additional catheters or interventional tools can also be provided, depending on potential needs during the intervention procedure.

[0051] With reference to FIG. 4, the hub 36 can represent any of the hubs previously described. The hub 36 includes a housing 38 extending between a proximal end 40 and a distal end 42. An interventional device 44, which can be any of the interventional devices disclosed herein, extends distally from the hub 36 into the patient 14 (not shown). The hub adapter 48, or carriage, acts as a shuttle by advancing proximally or distally along a track in response to operator instructions. The hub adapter 48 includes at least one drive magnet 50 that is configured to couple with a driven magnet 52 carried by the hub 36. This provides a magnetic coupling between the drive magnet 50 and the driven magnet 52 through the sterile barrier 32 such that the hub 36 and associated interventional device are moved across the top of the sterile barrier 32 within the sterile field in response to movement of the hub adapter 48 outside the sterile field. Movement of the hub adapter is driven by a drive system carried by the support table and is described in additional detail below.

[0052] To reduce friction in the system, the hub 36 may be provided with at least a first roller 54 and a second roller 56, which may be in the form of a wheel or a rotatable ball or drum. The rollers space the sterility barrier 32 from the surface of the driven magnet 52 by at least about 0.008" (and typically no more than about 0.03"). In some implementations of the invention, the space is within the range of about 0.010" to about 0.016". The space between the drive magnet 50 and the driven magnet 52 is typically no more than about 0.15", and in some implementations is no more than about 0.10" (e.g., within the range of about 0.085" to about 0.090"). The hub adapter 48 may likewise be provided with at least a first hub adapter roller 58 and a second hub adapter roller 60, which may be positioned opposite the respective first roller 54 and second roller 56, as illustrated in FIG. 4.

[0053] FIG. 16 illustrates a mechanical coupling mechanism 1654 between the drive mechanism 1650 and the driven mechanism 1652. The drive mechanism 1650 and the driven mechanism 1652 can be the same as or generally similar to the drive magnet 50 and the driven magnet 52, respectively, except as otherwise described herein. The drive mechanism 1650 can be part of or coupled to a hub adapter (e.g., hub adapter 48, etc.). The driven mechanism 1652 can be part of or coupled to a hub (e.g., hub 36, etc.). In some cases, the mechanical coupling mechanism 1654 can include a structural support (e.g., a support rod) that extends transversely through a seal in the sterile barrier 1632. The seal can allow the structural support to be advanced along the length of the sterile barrier 1632 while still maintaining a seal with the structural support to maintain a sterile field when the drive mechanism 1650 and the driven mechanism 1652 are advanced and / or retracted as described herein. For example, the seal can include a tongue and groove closure mechanism along the sterility barrier 1632 that is configured to close on either side of the structural support as the structural support is advanced along the length of the sterility barrier 1632 while allowing passage of the structural support through the sterility barrier 1632 and maintaining a seal against the structural support. It will be understood by those skilled in the art that any of the embodiments as described herein can be modified to incorporate a mechanical coupling mechanism, for example, as shown in FIG.

[0054] 6, one example of a low profile linear drive support table 20 is illustrated generally. The support table 20 includes an elongated frame 50 extending between a proximal end 52 and a distal end 54. At least one support table support 56 is provided for stabilizing the support table 20 relative to a patient (not shown). The support 56 may include one or more legs or preferably articulated arms that are configured to allow movement and positioning of the frame 50 on or adjacent to the patient.

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

[0056] The second drive pulley 64 can be engaged with a second drive belt 66 that is configured to axially move a second carriage bracket 68 along an axial path over the support table 20. The third drive pulley 70 can be configured to drive a third drive belt 72 to axially advance a third carriage bracket 74 along the support table 20. Each of the carriage brackets is provided with a drive magnet assembly, previously discussed but not shown in FIG. 7, which can form a coupler for magnetically coupling to a corresponding driven magnet in the hub of the interventional device, as has been discussed.

[0057] A detailed view of the drive system is shown diagrammatically in FIG. 8. A drive support 74 may be carried by the frame 50 to support the drive assembly. The second drive pulley 64 is shown in elevation section as being rotationally driven by a motor 75 via a rotatable shaft 76. The rotatable shaft 76 may be rotatably carried by the support 74 via a first bearing 78, a shaft coupling 80, and a second bearing 79. The motor 75 may be stabilized by a motor bracket 82 connected to the drive support 74 and / or the frame 50. The belt drive assemblies for the first drive belt 60 and the third drive belt 72 may be constructed similarly and will not be detailed further herein.

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

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

[0060] For example, any of the catheters depicted in Figures 5A, 5B, or 11 generally include an elongated tubular body extending between a proximal end and a distal working end. The length and diameter of the tubular body will depend on the desired application. For example, lengths in the area of ​​about 120 cm to about 140 cm or more are typical for use in femoral access percutaneous transluminal coronary applications. Intracranial or other applications may require different catheter shaft lengths depending on the vascular access site.

[0061] Any of the catheters disclosed herein can be provided with a beveled distal tip. With reference to Figure 11, a distal catheter tip 110 includes a tubular body 112 that includes an advancement segment 114, a marker band 116, and a proximal segment 118. An inner tubular liner 120 can extend through the entire length of the distal catheter tip 110 and can include dip coated PTFE.

[0062] A reinforcing element 122 (eg, a braid or spring coil) is embedded within an outer jacket 124, which may extend the entire length of the catheter.

[0063] The advancing segment 114 terminates distally in an angled surface 126 to provide a leading side wall portion 128 having a length measured between a distal end 130 and a distal tip 132 of the marker band 116. A trailing side wall portion 134 of the advancing segment 114 has an axial length in the illustrated embodiment approximately equal to the axial length of the leading side wall portion 128 as measured approximately 180 degrees around the catheter from the leading side wall portion 128. The leading side wall portion 128 can have an axial length in the range of about 0.1 mm to about 5 mm (generally in the range of about 1 mm to 3 mm). The trailing side wall portion 134 can be equal to the axial length of the leading side wall portion 128 or at least about 0.1 mm or 0.5 mm or 1 mm or 2 mm or more shorter than it, depending on the desired performance.

[0064] The angled surface 126 is inclined at an angle A in the range of about 45 degrees to about 80 degrees from the longitudinal axis of the catheter. For certain implementations, the angle is in the range of about 55 degrees to about 65 degrees from the longitudinal axis of the catheter. In one implementation, the angle A is about 60 degrees. One result of an angle A less than 90 degrees is a major axis elongation of the area of ​​the distal port, which can increase the surface area of ​​the port and enhance clot aspiration or retention. Compared to the surface area of ​​a circular port (where angle A is 90 degrees), the area of ​​the angled port is generally at least about 105% and not more than about 130% of the area of ​​the corresponding circular port (where angle A is 90 degrees), in some implementations in the range of about 110% to about 125%, and in one example, about 115%.

[0065] In the illustrated embodiment, the axial length of the advancement segment is substantially constant around the circumference of the catheter such that the angled surface 126 is approximately parallel to the distal surface 136 of the marker band 116. The marker band 116 has a proximal surface that is approximately transverse to the longitudinal axis of the catheter, creating the marker band 116 having a right-angled trapezoidal configuration in side view. The short sidewall 138 is rotationally aligned with the rear end sidewall portion 134 and has an axial length in the range of about 0.2 mm to about 4 mm, typically in the range of about 0.5 mm to about 2 mm. The opposing long sidewall 140 is rotationally aligned with the front end sidewall portion 128. The long sidewall 140 of the marker band 116 is generally at least about 10% or 20% longer than the short sidewall 138, and can be at least about 50% or 70% or 90% or more longer than the short sidewall 138 depending on the desired performance. Typically, the long sidewall 140 will have a length of at least about 0.5 mm or 1 mm, and less than about 5 mm or 4 mm.

[0066] The marker band can be a continuous annular structure or can have at least one, and optionally two or three or more, axially extending slits throughout its length. The slits can be located on or between the short sidewall 138 or the long sidewall 140 depending on the bending characteristics desired. The marker band can comprise any of a variety of radiopaque materials (such as, for example, a platinum / iridium alloy) having a wall thickness preferably of about 0.003 inches or less, and in one implementation, about 0.001 inches.

[0067] The marker band zone of the assembled catheter can have a relatively high bending stiffness and high crush strength (e.g., at least about 50% or at least about 100% less than the proximal segment 118, but typically no more than about 200% less than the proximal segment 118). The high crush strength can provide radial support to the adjacent advancement segment 114, and particularly to the leading end sidewall portion 128, promote the distal tip 132 to function as an atraumatic bumper during transluminal advancement, and resist collapse upon vacuum application. The proximal segment 118 preferably has a lower bending stiffness than the marker band zone, and the advancement segment 114 preferably has an even lower bending stiffness and crush strength than the proximal segment 118.

[0068] The advancing segment 114 can include an outer tubular jacket 124 and optionally a distal extension of the inner liner 120 without any other internal support structure distal to the marker band 116. The outer jacket 124 can include extruded Tecothane. The advancing segment 114 can have bending stiffness and radial crush stiffness that are about 50% or less than the corresponding values ​​for the proximal segment 118, and in some implementations, about 25% or 15% or 5% or less.

[0069] The catheter may further include an axial tension element or support, such as a ribbon or one or more filaments or fibers to increase tension resistance and / or affect bending characteristics in the distal zone. The tension support may include one or more axially extending monostrand or multistrand filaments 142. The tension element or elements 142 may be axially located inside the catheter wall near the distal end of the catheter. The tension element or elements 142 may act as a tension support to resist detachment or stretching of the tip of the catheter wall under tension (e.g., as the catheter is retracted proximally through a kinked outer catheter or a tortuous or narrowed vasculature).

[0070] At least one of the one or more tension elements 142 can extend proximally along the length of the catheter wall from within about 1.0 cm of the distal end of the catheter, to less than about 10 cm from the distal end of the catheter, to less than about 20 cm from the distal end of the catheter, to less than about 30 cm from the distal end of the catheter, to less than about 40 cm from the distal end of the catheter, or to less than about 50 cm from the distal end of the catheter.

[0071] One or more tension elements 142 can have a length greater than or equal to about 40 cm, greater than or equal to about 30 cm, greater than or equal to about 20 cm, greater than or equal to about 10 cm, or greater than or equal to about 5 cm.

[0072] At least one of the one or more tension elements 142 can extend for at least about 50 cm of the most distal length of the catheter, for at least about 40 cm of the most distal length of the catheter, for at least about 30 cm or 20 cm or 10 cm of the most distal length of the catheter.

[0073] In some implementations, the tension element extends proximally from the distal end of the catheter along the length of the coil 24, terminating proximally within about 5 cm or 2 cm or less on either side of the transition between the distal coil and the proximal braid. The tension element can terminate at the transition without overlapping the braid.

[0074] One or more tension elements 142 can be located near the inner liner 120 or radially outside the inner liner 120. One or more tension elements 142 can be located near the braided string and / or coil or radially inside the braided string and / or coil. One or more tension elements 142 can be carried between the inner liner 120 and the helical coil and can be secured to the surface of the inner liner or other underlying layer by adhesive prior to the addition of the next outer adjacent layer (e.g., coil, etc.). Preferably, the tension elements 142 are secured to the marker band 116, for example, by adhesive or by mechanical interference. In one implementation, the tension elements 142 extend distally beyond the marker band on a first (e.g., inner) surface of the marker band, then wrap around the distal end of the marker band, extend along a second (e.g., outer) surface in either or both a proximal angled direction or a circumferential direction, and wrap completely around the marker band.

[0075] When two or more tension elements 142 or filament bundles are spaced apart circumferentially in the catheter wall, the tension elements 142 can be placed in a radially symmetric manner. For example, the angle between two tension elements 142 relative to the radial center of the catheter can be about 180 degrees. Alternatively, depending on the desired clinical performance (e.g., flexibility, trackability), the tension elements 142 can be placed in a radially asymmetric manner. The angle between any two tension elements 142 relative to the radial center of the catheter can be less than or equal to 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.

[0076] The tension element(s) 142 may include materials such as Vectran, Kevlar, polyester, Meta-Para-Aramide, or any combination thereof. At least one of the tension element(s) 142 may include a single fiber or a multi-fiber bundle, and the fiber or bundle may have a round or rectangular (e.g., ribbon) cross-section. The term fiber or filament does not convey composition, and they may include any of a variety of high tensile strength polymers, metals, or alloys, depending on design considerations such as desired tensile fracture limits and wall thickness. The cross-sectional dimensions of the tension element(s) 142 as measured radially may be no greater than about 2%, 5%, 8%, 15%, or 20% of those of the catheter 10.

[0077] The cross-sectional dimension of one or more tension elements 142 when measured in the radial direction can be about 0.001 inch or less, about 0.002 inch or less, about 0.004 inch or less, about 0.006 inch or less, about 0.008 inch or less, or about 0.015 inch or less.

[0078] One or more tensioning elements 142 can increase the tensile strength of the distal zone of the catheter prior to failure under tension (e.g., marker band detachment) 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.

[0079] Any of a variety of sensors can be provided on either the catheter, the hub, the carriage, or the table, depending on the data desired. For example, in some implementations of the invention, it may be desirable to measure axial tension or compression forces applied to the catheter, such as along a force sensing zone. The distal end of the catheter would be constructed in a similar configuration with a helical coil distal section, as illustrated in FIG. 11. However, instead of using a single helical coil of Nitinol wire, a first conductor 140 and a second conductor 142 are wound into an intertwined helical coil and are electrically isolated from each other, such as by the plastic / resin of the tubular body. See FIG. 12A. Each coil is in electrical communication with the proximal hub by a unique electrical conductor (e.g., a conductive trace or a proximal extension of a wire).

[0080] This configuration of dual electrically isolated helical coils creates a capacitor. It is roughly equivalent to two plates of Nitinol with a plastic layer between them, as shown in FIG. 12B. The capacitance is inversely proportional to the distance between the wires. The only variable that will change will be d (the distance between the plates). If an axial compressive force is applied to the catheter, the wires 140 and 142 will move closer together, thus increasing the capacitance. If an axial tensile force is applied, the wires will move further apart, decreasing the capacitance. This capacitance can be measured at the proximal end of the catheter, giving a measure of the force on the helical capacitor. Although called a capacitor, the sensor is measuring the electrical interaction between the two coils of wire. Due to the applied axial force, there may be a measurable change in inductance or other resulting changes.

[0081] At least a first helical capacitor can have at least 1 or 5 or 10 or more complete turns of each wire. The capacitor can be positioned within the most distal 5 or 10 or 20 cm of the catheter body to sense forces experienced at the distal end. At least a second capacitor can be provided within the most proximal 5 or 10 or 20 cm of the catheter body to sense forces experienced at the proximal end of the catheter.

[0082] It may also be desirable to measure the elastic force across the magnetic coupling between the hub and the corresponding carriage, using the natural compliance of the magnetic coupling to measure the force applied to the hub. The magnetic coupling between the hub and the carriage creates a spring. When a force is applied to the hub, the hub will move a small amount relative to the carriage. See FIG. 13A. In robotics, this is called a series elastic actuator. This property can be used to measure the force applied to the hub from the carriage. To measure the force, the relative distance between the hub and the carriage (dx shown in FIG. 13A) is determined, characterizing some effective spring constant k between the two components. See FIG. 13B.

[0083] The relative distance can be measured in a number of different ways.

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

[0085] Other non-contact distance sensors can also be used. These include optical, inductive, and capacitive sensors. Optical sensors will preferably be configured in a manner that avoids the accumulation of blood or other fluids at the interface between the hub and the carriage.

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

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

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

[0089] Resistive strain gauges can be integrated into the body of the catheter or guidewire to measure force or torque, such as at the distal tip and / or proximal end of the device.

[0090] The absolute position of the hub (and corresponding catheter) along the length of the table can be determined in a variety of ways. For example, a non-contact magnetic sensor can be configured to measure the position of the hub directly through the sterile barrier, and the same type of sensor can be configured to measure the position of the carriage. Each hub can have at least one magnet attached to it. The robotic table will have a corresponding linear array of magnetic sensors spanning the length of the table. A processor can be configured to determine the location of the magnets along the length of the linear sensor array and display the axial position information to the physician.

[0091] The foregoing can alternatively be accomplished using a non-contact inductive sensor to directly measure the position of the pack through the sterile barrier. Each hub or carriage can be provided with an inductive "target" therein. The robot table can be provided with an inductive sensing array throughout the working length of the table. As a further alternative, an absolute linear encoder can be used to directly measure the linear position of the hub or carriage. The encoder can use any of a variety of different technologies, including optical, magnetic, inductive and capacitive methods.

[0092] In one implementation, a passive (no electrical connection) target coil can be carried by each hub. A linear printed circuit board can run the entire working length of the table (e.g., at least about 5' or 6') that is configured to ping an interrogator signal that stimulates a return signal from the passive coil. The PCB is configured to identify the return signal and its location.

[0093] The axial position of the carriage can be determined using a multi-turn rotary encoder to measure the rotational position of the pulley, which directly correlates to the linear position of the carriage. Direct measurement of the carriage location can alternatively be achieved by recording the number of steps commanded to a stepper motor to measure the rotational position of the pulley, which directly correlates to the linear position of the carriage.

[0094] The location of the catheter and guidewire within the anatomy can be determined by processing the fluoroscopic images with machine vision, for example to determine distal tip position, distal tip orientation, and / or guidewire shape. This processing can be done in real time to provide position / orientation data at up to 30hz (the maximum speed of the fluoro), although this technique will only provide data while the fluoro is turned on.

[0095] The proximal torque applied to a catheter or guidewire shaft can be determined using a dual encoder torque sensor. Referring to FIG. 14, a first encoder 144 and a second encoder 146 can be spaced axially along a shaft 148 to measure the difference in angle over the length of the flexible catheter / tube. Since the catheter / tube has a known torsional stiffness, the difference in angle 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) gives the torque: T=k*dθ, where k is the torsional stiffness.

[0096] Ensuring the absence of bubbles in the fluid line can also be accomplished using a bubble sensor, especially when 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 ultrasound reflected through the sidewall of the fluid tubing to detect bubbles and measure fluid flow rate or level. An ultrasonic or optical sensor can be positioned adjacent to the inflow fluid flow path in the hub or in the supply line leading to the hub. To detect the presence of air bubbles in the infusion line (which is formed from an ultrasonically or optically transparent material), the sensor can include a signal source on a first side of the flow path and a receiver on a second side of the flow path to measure the transmission through the liquid passing through the tubing and detect bubbles. Alternatively, the reflected ultrasonic signal can be detected from the same side of the flow path as the source due to the relatively high echogenicity of bubbles.

[0097] Preferably, the bubble removal system is activated automatically upon detection of a bubble in the line. The processor can be configured to activate a valve positioned in the flow path downstream of the bubble detector upon detection of a bubble. The valve diverts a column of fluid from the flow path to the patient and into the reservoir. Once bubbles are no longer detected in the flow path and after a volume of fluid in the flow path between the detector and the valve has passed through the valve, the valve can be activated to reconnect the source of fluid with the patient through the flow path.

[0098] Additionally, it may be desirable for the physician to view the aspirated clot at a location in the sterile field and preferably as close to the patient as practical for fluid management purposes. This can be accomplished by providing a clot retrieval device mounted on the hub or mounted in the suction line leading away from the hub toward the pump. With reference to FIG. 15, one example of a clot retrieval device 370 can include a body portion 380 enclosing a chamber 381, the chamber 381 being in communication with a first port 310 and a second port 320. In some examples, the body portion 380 can include a flush port (not shown) configured to allow injection of saline or other fluid into the chamber 381 to improve clot visualization when the clot is captured in the filter 330.

[0099] 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 in a chamber 381 between the top portion 382 and the bottom portion 384. 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 a suction catheter. In embodiments configured to connect downstream from a hub, the first tube 340 includes a connector 342 that is positioned at a second end of the first tube 340 that is configured to engage or mate with a corresponding connector on or in communication with the hub. A first port 310 is in direct communication with the chamber upstream (e.g., top side) of the filter, and a second port 320 is in direct communication with the chamber downstream (e.g., bottom side) of the filter, facilitating direct visualization of material trapped on the upstream side of the filter. In implementations configured for remote operation, any of a variety of sensors can be provided, such as optical sensors, ultrasonic sensors, or others known in the art, to detect clots passing through the aspiration line and / or trapped in the filter.

[0100] In some embodiments, the second port 320 is configured to connect to a first end of a second tube 350 that is fluidly connected to a suction source (e.g., a pump). In some embodiments, the second tube 350 includes a connector 352 that is positioned on a second end of the second tube 350 that is configured to engage or mate with a corresponding connector on the pump. In some examples, the system 300 can include a clamp 360. The clamp 360 can be positioned on the first tube 340 to allow a user to engage the clamp and provide flow control to the clot retrieval device 370.

[0101] The body portion 380 can have a top surface spaced apart from a bottom surface by a tubular sidewall. In the illustrated implementation, the top and bottom surfaces are substantially circular and spaced apart by a cylindrical sidewall having a diameter at least about three or five or more times greater than the axial length (transverse to the top and bottom surfaces) of the sidewall, creating a generally disk-shaped housing. Preferably, at least a portion of the top wall is optically transparent to improve clot visualization when a clot is trapped within the clot retrieval device 370. Additional details can be found in U.S. Patent No. 6,233,993, each of which is incorporated herein by reference in its entirety.

[0102] The foregoing represent certain specific implementations of drive tables and associated catheters, and as will be recognized by those of skill in the art in light of the disclosure herein, a wide variety of different drive table configurations can be made to robotically drive an interventional device, to support two or three or four or more drive magnet assemblies, and to advance and retract axially.

[0103] Exemplary embodiments The supra-aortic vascular access robotic control system includes one or more of the following: a guidewire hub configured to adjust each of the axial and rotational positions of the guidewire; a guide catheter hub configured to axially adjust the guide catheter; and A second catheter hub, the second catheter hub configured to adjust each of the axial and rotational positions of the second catheter and configured to laterally deflect a distal deflection zone of the second catheter.

[0104] The control system as described in any embodiment herein, wherein the second catheter is a suction catheter.

[0105] The control system as described in any embodiment herein, wherein the second catheter is an indwelling embolization catheter.

[0106] The control system as described in any embodiment herein, wherein the second catheter is configured to place an embolic coil.

[0107] The control system as described in any embodiment herein, wherein the second catheter is a stenting catheter.

[0108] The second catheter is configured to deploy a stent retriever, and the control system as described in any embodiment herein.

[0109] The control system as described in any embodiment herein, wherein the second catheter is a flow diverter placement catheter.

[0110] The control system as described in any embodiment herein, wherein the second catheter is a diagnostic angiography catheter.

[0111] A control system as described in any embodiment herein, further comprising a driven magnet on the guidewire hub, the driven magnet configured to cooperate with the drive magnet such that the driven magnet moves in response to movement of the drive magnet.

[0112] A control system as described in any embodiment herein, wherein the drive magnet is axially movably carried by a support table.

[0113] A control system as described in any embodiment herein, wherein the drive magnet moves outside of the sterile field separated from the driven magnet by a barrier, and the driven magnet is within the sterile field.

[0114] The control system as described in any embodiment herein, wherein the barrier comprises a polymeric membrane.

[0115] A control system as described in any embodiment herein, further comprising a control console located remotely from the support table.

[0116] A control system as described in any embodiment herein, wherein the position of the driven magnet is movable in response to manipulation of a guidewire drive control on the console.

[0117] A control system as described in any embodiment herein, further comprising a processor for controlling the position of the driven magnet, the processor being in wired communication with the control console.

[0118] A control system as described in any embodiment herein, further comprising a processor for controlling the position of the driven magnet, the processor being in wireless communication with the control console.

[0119] A control system as described in any embodiment herein, wherein the driven magnet will remain engaged with the driving magnet until the applied force reaches a breakaway force threshold, above which the driven magnet will disengage from the driving magnet.

[0120] A control system as described in any embodiment herein, wherein the disruption force threshold is at least about 300 grams.

[0121] A control system as described in any embodiment herein, further comprising a sensor configured to measure a force applied between the driven magnet and the driving magnet.

[0122] A control system as described in any embodiment herein, further comprising a processor configured to compare the applied force to a disruption force threshold.

[0123] A control system as described in any embodiment herein, wherein the processor is configured to adjust the rate of movement of the drive magnet when the applied force reaches a preset value below the splitting force threshold.

[0124] The control system as described in any embodiment herein, wherein the sensor comprises a strain gauge.

[0125] A control system as described in any embodiment herein, wherein the processor is configured to stop movement of the drive magnet when the applied force reaches a preset value below the breakaway force threshold.

[0126] Robotically driven interventional devices include one or more of the following: an elongated flexible body having a proximal end and a distal end; a hub at the proximal end; at least one rotatable roller on the first surface of the hub; and At least one magnet on the first surface of the hub.

[0127] A robotically driven interventional device as described in any embodiment herein, wherein the rollers extend further from the first surface than the magnets.

[0128] A robotically driven interventional device as described in any embodiment herein, further comprising at least a second roller.

[0129] A robotically driven interventional device as described in any embodiment herein, further comprising a rotational drive in the hub for rotating the interventional device relative to the hub.

[0130] A robotically actuated interventional device as described in any embodiment herein, further including a retraction mechanism in the hub for proximally retracting a pull element extending through the interventional device.

[0131] A robotically actuated interventional device as described in any embodiment herein, wherein the pull element comprises a pull wire.

[0132] A robotically actuated interventional device as described in any embodiment herein, wherein the pull element comprises a pull tube.

[0133] A robotically actuated interventional device as described in any embodiment herein, wherein a shape of a portion of the tubular body changes in response to proximal retraction of the pull element.

[0134] A robotically actuated interventional device as described in any embodiment herein, wherein a stiffness characteristic of a portion of the tubular body is changed in response to proximal retraction of the pull element.

[0135] A robotically driven interventional device as described in any embodiment herein, further comprising a sensor on the elongated flexible body.

[0136] A robotically actuated interventional device as described in any embodiment herein, wherein the sensor includes an axial force sensor.

[0137] A robotically actuated interventional device as described in any embodiment herein, wherein the distal portion of the flexible body includes at least a first electrical conductor, the first electrical conductor being axially spaced apart from and insulated from the second electrical conductor.

[0138] A robotically actuated interventional device as described in any embodiment herein, wherein the first electrical conductor and the second electrical conductor are adjacent helical windings of a conductive wire.

[0139] A robotically actuated interventional device as described in any embodiment herein, wherein the sensor includes an oxygen sensor.

[0140] A robotically actuated interventional device as described in any embodiment herein, wherein the sensor includes a catheter shape sensor.

[0141] The sensor includes a catheter position sensor, and the robotically actuated interventional device as described in any embodiment herein.

[0142] The flexible body includes a guide catheter, and the robotically driven interventional device as described in any embodiment herein.

[0143] A robotically driven interventional device as described in any embodiment herein, wherein the flexible body includes a guidewire.

[0144] The flexible body is a robotically driven interventional device as described in any embodiment herein, including an access catheter.

[0145] A robotically actuated interventional device as described in any embodiment herein, wherein the flexible body includes an aspiration catheter.

[0146] A robotically actuated interventional device as described in any embodiment herein, comprising a fiber Bragg grating sensor.

[0147] A robotically actuated interventional device as described in any embodiment herein, further comprising a clot filter in fluid communication with the hub.

[0148] The clot filter is carried by a hub of a robotically actuated interventional device as described in any embodiment herein.

[0149] A robotically actuated interventional device as described in any embodiment herein, wherein the clot filter has transparent sidewalls to allow visual inspection of the captured clots.

[0150] A robotically actuated interventional device as described in any embodiment herein, further comprising a bubble detector in fluid communication with the flow path through the hub.

[0151] The bubble detector is carried by a hub, a robotically driven interventional device as described in any embodiment herein.

[0152] A robotically actuated interventional device as described in any embodiment herein, further comprising a valve in the flow path and a processor configured to adjust the valve in response to detection of a bubble in the flow path.

[0153] A robotically actuated interventional device as described in any embodiment herein, wherein the bubble is diverted from the flow path in response to adjustment of the valve.

[0154] 1. A sterile packaging assembly for transporting an interventional device to a robotic surgical site, the sterile packaging assembly including one or more of the following: a sterile barrier having a hub support portion and configured to enclose a sterile volume; and At least a first interventional device in the sterile volume, the first interventional device including a hub and an elongated flexible body, the hub including at least one magnet and at least one roller, the at least one roller configured to roll on a hub support portion.

[0155] A sterile packaging assembly as described in any embodiment herein, wherein the hub support portion is configured to reside on a support table adjacent to a patient, an upper surface of the hub support portion being within a sterile field, and a lower surface of the hub support portion being outside the sterile field.

[0156] A sterile packaging assembly as described in any embodiment herein, wherein the hub support portion is substantially horizontal when resting on the support table.

[0157] A sterile packaging assembly as described in any embodiment herein, wherein the hub support portion is inclined relative to a horizontal plane when resting on the support table.

[0158] A sterile packaging assembly as described in any embodiment herein, wherein the hub further comprises at least one fluid injection port.

[0159] The sterile packaging assembly as described in any embodiment herein, wherein the hub further includes a wireless RF transceiver.

[0160] A sterile packaging assembly as described in any embodiment herein, further comprising a visual indicator on the hub to indicate the presence of a blood clot.

[0161] The visual indicator comprises a clot collection chamber having a transparent window, the sterile packaging assembly as described in any embodiment herein.

[0162] A sterile packaging assembly as described in any embodiment herein, further comprising a filter in the clot chamber.

[0163] A sterile packaging assembly as described in any embodiment herein, further comprising a sensor for detecting the presence of a blood clot.

[0164] A sterile packaging assembly as described in any embodiment herein, wherein the sensor comprises a pressure sensor.

[0165] The sterile packaging assembly as described in any embodiment herein, wherein the sensor comprises an optical sensor.

[0166] A sterile packaging assembly as described in any embodiment herein, wherein the hub support portion comprises an elongated polymeric membrane having a longitudinal axis.

[0167] A sterile packaging assembly as described in any embodiment herein, wherein the sterility barrier additionally comprises at least a first storage tray adjacent the hub support portion.

[0168] A sterile packaging assembly as described in any embodiment herein comprising a first storage tray and a second storage tray adjacent to a hub support portion.

[0169] A sterile packaging assembly as described in any embodiment herein, wherein a first storage tray is on a first side of the hub support portion and a second storage tray is on a second side of the hub support portion.

[0170] A sterile packaging assembly as described in any embodiment herein comprising a first storage tray and a second storage tray adjacent to a hub support portion.

[0171] A first interventional device is contained within a first storage tray, a sterile packaging assembly as described in any embodiment herein.

[0172] The sterile packaging assembly as described in any embodiment herein, wherein the first interventional device is a guide catheter.

[0173] The sterile packaging assembly as described in any embodiment herein, wherein the first interventional device is an access catheter.

[0174] The sterile packaging assembly as described in any embodiment herein, wherein the first interventional device is a guidewire.

[0175] The sterile packaging assembly as described in any embodiment herein, wherein the first interventional device is a suction catheter.

[0176] A sterile packaging assembly as described in any embodiment herein containing a supra-aortic vascular access assembly in a first storage tray.

[0177] The access assembly includes a guidewire, an access catheter, and a guide catheter, in a sterile packaging assembly as described in any embodiment herein.

[0178] A sterile packaging assembly as described in any embodiment herein, further comprising a procedural assembly within the sterile volume.

[0179] The procedural assembly includes a guidewire and an aspiration catheter, in a sterile packaging assembly as described in any embodiment herein.

[0180] The procedure assembly is carried in a second storage tray, a sterile packaging assembly as described in any embodiment herein.

[0181] A sterile packaging assembly as described in any embodiment herein, wherein the sterile barrier is magnetically permeable.

[0182] A sterile packaging assembly as described in any embodiment herein, wherein the sterility barrier is fluid impermeable.

[0183] A sterile packaging assembly as described in any embodiment herein, wherein the sterile barrier is radio frequency transparent.

[0184] A sterile packaging assembly as described in any embodiment herein, wherein the sterility barrier is impermeable to microorganisms.

[0185] A sterile packaging assembly as described in any embodiment herein, wherein the sterility barrier is translucent.

[0186] A sterile packaging assembly as described in any embodiment herein, wherein the sterility barrier is transparent.

[0187] A sterile packaging assembly as described in any embodiment herein, wherein the hub support portion has a convex curvature and is configured to allow fluid to flow away from the hub support portion.

[0188] A sterile packaging assembly as described in any embodiment herein, wherein the hub support portion has a longitudinal axis and a transverse axis, and the hub support portion is upwardly convex at the transverse axis.

[0189] A sterile packaging assembly as described in any embodiment herein, wherein the sterility barrier is contained within the outer packaging.

[0190] A sterile packaging assembly as described in any embodiment herein, wherein the sterility barrier comprises a non-compliant polymer.

[0191] The sterile packaging assembly as described in any embodiment herein, wherein the non-compliant polymer comprises polyethylene terephthalate (PET) or thermoplastic polyurethane.

[0192] A sterile packaging assembly as described in any embodiment herein, wherein the sterile barrier further includes a removable cover portion that cooperates with the hub support portion to define a sterile volume.

[0193] A sterile packaging assembly as described in any embodiment herein, wherein the hub is releasably coupled to the hub support portion via at least one magnet.

[0194] 1. A method of performing a neurovascular procedure, the method comprising one or more of the following steps: providing an access catheter having an access catheter hub; coupling the access catheter hub to a hub adapter, the hub adapter being movably carried by a support table; driving the access catheter in response to movement of the hub adapter along the table until the access catheter is positioned to provide supra-aortic vascular access; removing the access catheter and the access catheter hub from the hub adapter; and Connecting a treatment catheter hub having a treatment catheter to the hub adapter.

[0195] A method as described in any embodiment herein, further comprising the step of advancing the treatment catheter hub to position a distal end of the treatment catheter at a neurovascular treatment site.

[0196] The method as described in any embodiment herein, wherein driving the access catheter comprises driving the access catheter distally through a guide catheter.

[0197] A method as described in any embodiment herein, wherein the step of driving the access catheter includes a step of laterally deflecting a distal region of the access catheter to achieve supra-aortic vascular access.

[0198] A method as described in any embodiment herein, wherein the coupling step includes magnetically coupling the access catheter hub to the hub adapter.

[0199] The method as described in any embodiment herein, wherein the access catheter hub and the hub adapter are separated by a sterile field barrier.

[0200] A method as described in any embodiment herein, further comprising the step of connecting the guide catheter hub to the guide catheter adapter through a sterile barrier.

[0201] A method as described in any embodiment herein, further comprising the step of coupling a guidewire hub to a guidewire adapter through a sterile barrier.

[0202] A method as described in any embodiment herein, further comprising the step of axially moving a guidewire attached to the guidewire hub in response to axially moving the guidewire adapter.

[0203] A method as described in any embodiment herein, further comprising the step of rotating the guidewire relative to the guidewire hub.

[0204] The method as described in any embodiment herein, wherein the treatment catheter comprises a suction catheter.

[0205] A method as described in any embodiment herein, further comprising the step of aspirating the clot.

[0206] A method as described in any embodiment herein, further comprising the step of driving the access catheter in response to movement of the hub adapter along the table until the access catheter achieves supra-aortic vascular access.

[0207] A method as described in any embodiment herein, further comprising the step of maintaining supra-aortic vascular access while removing the access catheter.

[0208] A method as described in any embodiment herein, further comprising the step of maintaining supra-aortic vascular access while connecting a treatment catheter hub.

[0209] A method as described in any embodiment herein, wherein the coupling step includes coupling at least a first magnet on the access catheter hub to a second magnet on the hub adapter to form a magnetic coupling.

[0210] A method as described in any embodiment herein, further comprising measuring an elastic force across the magnetic coupling.

[0211] The method as described in any embodiment herein, further comprising determining a force applied to the access catheter.

[0212] The method as described in any embodiment herein, wherein the force determination is accomplished using an optical fiber embedded in the sidewall of the catheter.

[0213] A method as described in any embodiment herein, further comprising determining a location of the hub adapter relative to the table.

[0214] 1. A method of performing a neurovascular procedure, the method comprising one or more of the following steps: Providing an access assembly including a guidewire, an access catheter, and a guide catheter; coupling the access assembly to a robotic drive system; actuating the access assembly to achieve supra-aortic vascular access; releasing the guidewire and the access catheter from the access assembly; providing a procedural assembly including at least a guidewire and a procedural catheter; coupling the treatment assembly to a robotic drive system; and Performing a neurovascular procedure using the procedure assembly.

[0215] A method as described in any embodiment herein, wherein the step of coupling the access assembly includes magnetically coupling hubs on each of the guidewire, access catheter, and guide catheter to separate corresponding drive magnets that are independently movably carried by the drive table.

[0216] A method as described in any embodiment herein, wherein the step of coupling the access assembly to the robotic drive system is accomplished without direct contact between the access assembly and the robotic drive system.

[0217] The method as described in any embodiment herein, wherein the treatment assembly includes a first treatment catheter and a second treatment catheter.

[0218] A method as described in any embodiment herein, wherein the guidewire and the first treatment catheter are concentrically positioned within the second treatment catheter.

[0219] A method as described in any embodiment herein, wherein the treatment assembly is advanced as a unit through at least a portion of the length of the guide catheter.

[0220] The method as described in any embodiment herein, wherein the treatment comprises a neurovascular thrombectomy.

[0221] A method as described in any embodiment herein comprising the step of axially advancing or retracting a guidewire.

[0222] A method as described in any embodiment herein comprising rotating the guidewire relative to the guidewire hub.

[0223] A method as described in any embodiment herein comprising axially advancing or retracting an access catheter.

[0224] A method as described in any embodiment herein comprising rotating the access catheter relative to the access catheter hub.

[0225] A method as described in any embodiment herein comprising the step of laterally deflecting a deflection zone on the access catheter.

[0226] A method as described in any embodiment herein, wherein a hub on each of the guidewire, access catheter, and guide catheter is separated from the corresponding drive magnet by a sterile field barrier.

[0227] A method as described in any embodiment herein, wherein driving the access assembly includes rolling hubs on each of the guidewire, the access catheter, and the guide catheter along the sterile field barrier in response to movement of the drive magnet.

[0228] A method as described in any embodiment herein, further comprising the step of maintaining supra-aortic vascular access while releasing at least one of the guidewire and the access catheter from the access assembly.

[0229] A method as described in any embodiment herein, further comprising the step of maintaining supra-aortic vascular access while connecting the procedural assembly.

[0230] A method as described in any embodiment herein, further comprising determining relative movement between magnets in the hub and corresponding magnets carried by the drive table.

[0231] A method as described in any embodiment herein, further comprising determining a location of the hub relative to the drive table.

[0232] The method as described in any embodiment herein, further comprising determining an axial force applied to the access catheter.

[0233] The method as described in any embodiment herein, further comprising determining a rotational torque applied to the access catheter. [Explanation of symbols]

[0234] 10 Interventional Setup 12 Patient Support Table 14 patients 16 Imaging Systems 18 Robotic interventional device drive system 20 Support Table 22 Interventional Devices 23 Display 24 Femoral Access Point 26 Guidewire Hub 27 Guidewire 28 Access Catheter Hub 29 Access Catheter 30 Guide Catheter Hub 31 Guide Catheter 32 Sterile Barrier 34 Anti-buckling features 36 Hub 38 Housing 40 Proximal end 42 Distal end 44 Interventional Devices 48 Hub Adapter 50 Drive magnet, frame 52 Driven magnet, proximal end 54 First roller, distal end 56 Second roller, support 58 1st hub adapter roller, 1st drive pulley 60 Second hub adapter roller, first drive belt 61 First carriage bracket 62 Drive pulley teeth 64 Second drive pulley 66 Second Drive Belt 68 Second Carriage Bracket 70 3rd drive pulley 72 3rd Drive Belt 74 Third carriage bracket, drive support 75 Motor 76 Rotatable Shaft 78 First Bearing 79 Second Bearing 80 Shaft Coupling 82 Motor bracket 84 No. 1 idler pulley 86 Second idler pulley 88 3rd idler pulley 90 Tensioning bracket 92 Tension adjustment 94 Rotatable Shaft 96 First Bearing 98 Second Bearing 100 Proximal end 102 Distal end 104 Upper support surface 106 First Channel 108th Floor 110 Outer wall 111 Inner wall 112 Second Channel 114 Forward Segment 116 Marker Band 118 Proximal Segment 120 First treatment catheter, inner liner 122 Hub, Reinforcement Element 124 Second treatment catheter, outer jacket 126 Hub, Angled Face 128 Front end side wall part 130 Distal end 132 Distal tip 134 Rear end side wall part 136 Distal Surface 138 Short side wall 140 Long side wall, first conductor 142 tension element, second conductor 144 1st Encoder 146 Second Encoder 148 Shaft 310 First Port 320 Secondary Port 330 Filter 340 First Tube 342 Connector 350 Second Tube 352 Connector 360 Clamp 370 Clot Retrieval Device 380 Main body 381 Chamber 382 Upper part 384 Bottom part 1632 Sterile Barrier 1650 Drive Mechanism 1652 Driven Mechanism 1654 Mechanical Coupling Mechanism A Angle

Claims

1. An elongated flexible body portion having a proximal end and a distal end; a hub at the proximal end; at least one rotatable roller on a first surface of the hub; at least one magnet on the first surface of the hub; A robotically driven interventional device comprising:

2. A robotically driven interventional device as described in claim 1, wherein the roller extends further from the first surface than the magnet.

3. A robotically driven interventional device as described in claim 2, further comprising at least a second roller.

4. A robotically driven interventional device as described in claim 1, further comprising a rotational drive within the hub for rotating the interventional device relative to the hub.

5. A robotically driven interventional device as described in claim 1, further comprising a retraction mechanism within the hub for proximally retracting a pull element extending through the interventional device.

6. A robotically controlled interventional device as described in claim 5, wherein the pull element includes a pull wire.

7. A robotically driven interventional device as described in claim 5, wherein the pull element includes a pull tube.

8. A robotically controlled interventional device as described in claim 5, wherein the shape of a portion of the flexible main body changes in response to proximal retraction of the pull element.

9. A robotically driven interventional device as described in claim 5, wherein the stiffness characteristics of a portion of the flexible body portion change in response to proximal retraction of the pull element.

10. A robotically driven interventional device as described in claim 1, further comprising a sensor on the elongated flexible body portion.

11. A robotically controlled interventional device as described in claim 10, wherein the sensor includes an axial force sensor.

12. A robotically driven interventional device as described in claim 11, wherein the distal portion of the flexible body includes at least a first electrical conductor, the first electrical conductor being axially spaced apart from and insulated from a second electrical conductor.

13. A robotically controlled interventional device as described in claim 12, wherein the first electrical conductor and the second electrical conductor are adjacent spiral windings of conductive wire.

14. A robotically controlled interventional device as described in claim 10, wherein the sensor includes an oxygen sensor.

15. A robotically controlled interventional device as described in claim 10, wherein the sensor includes a catheter shape sensor.

16. A robotically controlled interventional device as described in claim 10, wherein the sensor includes a catheter position sensor.

17. A robotically driven interventional device as described in claim 1, wherein the flexible main body portion includes a guide catheter.

18. A robotically driven interventional device as described in claim 1, wherein the flexible main body portion includes a guide wire.

19. The robotically driven interventional device of claim 1, wherein the flexible body portion includes an access catheter.

20. A robotically driven interventional device as described in claim 1, wherein the flexible main body portion includes a suction catheter.

21. A robotically driven interventional device as described in claim 10, including a fiber Bragg grating sensor.

22. A robotically driven interventional device as described in claim 1, further comprising a clot filter in fluid communication with the hub.

23. A robotically driven interventional device as described in claim 22, wherein the clot filter is carried by the hub.

24. A robotically actuated interventional device as described in claim 22, wherein the clot filter has transparent side walls to allow visual inspection of captured clots.

25. A robotically controlled interventional device as described in claim 1, further comprising a bubble detector in fluid communication with a flow path through the hub.

26. A robotically controlled interventional device as described in claim 25, wherein the bubble detector is carried by the hub.

27. A robotically actuated interventional device as described in claim 25, further comprising a valve in the flow path and a processor configured to adjust the valve in response to detection of a bubble in the flow path.

28. A robotically controlled interventional device as described in claim 27, wherein a bubble is diverted from the flow path in response to adjustment of the valve.

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