Manage, track, and control coaxial endovascular assemblies

Abstract

The endovascular management and tracking system includes a track and at least one shuttle to which at least one elongated medical device is respectively attached, each shuttle configured to be mechanically coupled to the track, each shuttle includes a sled configured to run on the track, an axial drive mechanism carried by the sled and configured to be actuated to axially translate each shuttle along the track, and a first actuator carried by the sled and configured to actuate the axial drive mechanism.

Description

[Technical field]

[0001] TECHNICAL FIELD This disclosure relates generally to intravascular catheters and intravascular procedures, and more specifically to techniques for managing and controlling coaxial intravascular assemblies. [Background technology]

[0002] The use of intravascular medical instruments has become an effective method for the diagnosis and / or treatment of many types of vascular diseases. In general, a suitable intravascular device is inserted into a patient's vascular system and guided through the vascular system to a desired target site. Using this method, almost any target site in a patient's vascular system can be accessed, including coronary arteries, cerebral vessels, peripheral vessels, etc.

[0003] In a conventional endovascular procedure, a guide sheath is inserted into the patient's femoral artery via an introducer and positioned proximate to the intravascular target site. A guide wire is then inserted into the guide sheath and manipulated through the patient's arterial system until the guide wire reaches the intravascular target site. A working catheter is then moved along the guide wire until the distal end of the working catheter is located proximate to the intravascular target site. The working catheter can then be manipulated to perform a diagnostic and / or interventional procedure at the intravascular target site. Manipulation of the catheter and guide wire typically requires manual advancement and rotation of these instruments to facilitate passage through the patient's tortuous vascular system. Rotating hemostatic valves (RHVs) are typically used between the fluid manifold and each catheter to supply fluid to the catheter and allow rotation of the catheter during catheter manipulation while simultaneously preventing backflow of blood through the catheter.

[0004] Performing such endovascular procedures reliably and accurately is highly tedious, requires significant time and skill, and can result in high levels of fatigue for the surgeon. Because such endovascular procedures are typically performed under fluoroscopic guidance to allow the surgeon to visualize the placement of catheters and guidewires relative to the patient's anatomy, the surgeon performing many catheter procedures is subject to significant radiation exposure over time.

[0005] To facilitate precise and robust control of intravascular devices and reduce radiation exposure risk to the surgeon, numerous robotic endovascular systems have been proposed to manipulate intravascular devices (e.g., track each other) and some have been implemented in clinical practice. Typically, such robotic endovascular systems operate intravascular devices by providing instructions in the form of input commands to a master input device (as a mechanical surrogate) (e.g., via a joystick or other controller operated by the surgeon) and translating these instructions into motion instructions for slave devices of such robotic endovascular systems. Several fully automated algorithms and / or extended motions for robotic endovascular systems have been proposed, such as adding guidewire dotters, twisting and retracting intravascular devices, or simultaneously moving multiple intravascular devices (e.g., moving catheters and delivery wires to deploy stents).

[0006] With the advent of robotic endovascular systems, the work area has become much more streamlined and efficient, as all the equipment on the table, such as catheters, guidewires, rotating hemostatic valves, and fluid manifolds, are necessarily organized or incorporated by components of the robotic system. However, known robotic endovascular systems use arms that extend above the operating table to manipulate the endovascular devices. Known robotic systems are large, clumsy to operate, and relatively expensive to manufacture. Furthermore, the presence of a robot at the surgical site is problematic, especially if the robot is large, and may impede access to the patient during surgery.

[0007] Additionally, to prevent catheter dislodgement when advancing flexible catheters, current robotic systems tend to use friction roller advancement or other drive systems, which require significant catheter lengths to be rendered unusable for access and can lead to catheter stack-up issues. Most current catheters are designed to minimize the unusable length (i.e., the length of a single RHV) to fully utilize variable catheter robotic endovascular systems, which may require custom-length catheters or preclude certain endovascular procedures due to length compatibility issues with current catheter robotic systems.

[0008] Also, not all endovascular procedures are best performed with full teleoperation (i.e., remotely providing input commands to a master input device). In many situations, manual operation of an endovascular device is necessary or highly desirable. However, known robotic systems do not easily provide access to manual operation (direct hand manipulation of the endovascular device) when desired or required in an emergency, while still carrying the endovascular device, and do not easily adapt dynamically to different catheter workflows. In other situations, manual manipulation of parts of the endovascular device during an endovascular procedure is necessary or highly desirable, while other parts of the endovascular device are necessary or highly desirable to be automatically operated during the same endovascular procedure. However, known robotic systems are not capable of operating in such a hybrid manual / automatic mode. In contrast, purely manual systems often require two humans (e.g., a physician and a trained assistant) to manually operate different endovascular devices in a synchronized manner to perform a desired medical procedure.

[0009] Thus, there is a need for an improved endovascular management and tracking system that is easy to set up and customize for various hospital environments and catheter workflows, prevents catheter dislodgement, is relatively inexpensive, can be used with standardized catheter lengths, can be easily converted from robotic to manual operation, and / or can be operated in a hybrid manual / automated mode. Summary of the Invention

[0010] According to a first aspect of the invention, an endovascular management and tracking system includes a track (which may or may not be flexible) and at least one shuttle to which at least one elongated medical instrument (e.g., a guide sheath, a working catheter, and / or a guidewire) can each be attached. Each shuttle includes a sled configured to be mechanically coupled to the track and configured to ride on the track, an axial drive mechanism carried by the sled and configured to be actuated to axially translate each shuttle along the track, and a first actuator (e.g., a manual actuator or a motor) carried by the sled and configured to actuate the axial drive mechanism. Each of the shuttles may optionally include a rotational drive mechanism carried by the sled and configured to be actuated to rotate the respective elongated medical instrument about its longitudinal axis, and a second actuator (e.g., a manual actuator or a motor) carried by the sled and configured to actuate the rotational drive mechanism.

[0011] In one embodiment, the endovascular management and tracking system includes a plurality of shuttles to which a plurality of elongated medical instruments are respectively attached. In this embodiment, each of the plurality of shuttles may be configured to be removably mechanically coupled to the track, e.g., threaded or transversely fitted to the track. In this embodiment, each trailing one of the plurality of shuttles is configured to slidably receive a distal end of a respective one of the plurality of elongated medical instruments attached to a leading one of the plurality of shuttles, such that each elongated medical instrument attached to the leading shuttle is coaxially disposed within each one of the plurality of elongated medical instruments attached to the trailing shuttle. In an optional embodiment, one of the plurality of shuttles may be a master shuttle and another one of the plurality of shuttles may be a slave shuttle. In this embodiment, the endovascular management and tracking system further includes a controller (e.g., an electrical controller or a mechanical controller) configured to actuate an axial drive mechanism of the slave shuttle in response to actuation of an axial drive mechanism of the master shuttle, such that the slave shuttle moves axially along the track in synchronization with the axial movement of the master shuttle along the track.

[0012] In another embodiment, each of the shuttles further includes an on-board fluid management and control assembly carried by the sled and configured to be fluidly coupled to an elongated medical instrument attached to the respective shuttle, hi this embodiment, the on-board fluid management and control assembly may include a rotating hemostasis valve (RHV) configured to be removable from the respective shuttle.

[0013] In yet another embodiment, the intravascular management and tracking system further includes a locking mechanism carried on the sled and configured to be manually operated to alternately engage and disengage the axial drive mechanism from the track. In yet another embodiment, each of the elongate medical instruments is flexible, and each of the one or more shuttles further includes an anti-buckling mechanism configured to prevent the respective elongate medical instrument from prolapsing in response to axial compression applied to the respective elongate medical instrument. Each of the anti-buckling mechanisms may include a tubular member configured to slideably dispose the respective elongate medical instrument. Such a tubular member may have a slit extending along the length of the tubular member. In this embodiment, the distal end of each of the anti-buckling mechanisms is configured to be fixed in a predetermined position, and each of the anti-buckling mechanisms is configured to lengthen as the respective shuttle moves axially away from the position and to shorten as the respective shuttle moves axially toward the position. The position at which the distal end of one of the anti-buckling mechanisms is fixed may be a fixed position relative to the patient. If the endovascular management and tracking system includes multiple shuttles, the position at which the distal end of the anti-buckling mechanism of a leading one of the multiple shuttles is attached may be a trailing one of the multiple shuttles. In one embodiment, the anti-buckling mechanism includes an axial drive mechanism.

[0014] The robotic endovascular system may include the endovascular management and tracking system described above, and a master input device configured to receive manual commands from a user and send control signals to the motors of each shuttle. In the robotic endovascular system, each of the shuttles may optionally include a manual actuator configured to actuate an axial drive mechanism.

[0015] According to a second aspect of the invention, an intravascular management and tracking system includes a flexible track and at least one shuttle, each of which can have at least one elongated medical device (e.g., a guide sheath, a working catheter, and / or a guidewire) attached thereto. In one embodiment, the flexible track can have a top-to-bottom flexibility and a side-to-side flexibility that is less than the top-to-bottom flexibility. In any embodiment, the flexible track includes multiple flexible track segments configured to be removably attached to one another. Each shuttle is configured to be mechanically coupled to the track. In one embodiment, the flexible track is an open monorail on which the shuttle rides.

[0016] The endovascular management and tracking system further includes a drive assembly (e.g., manually or motor-actuated) configured to axially translate the shuttle along the flexible track. In one embodiment, the flexible track is configured to be contoured by a user to a hospital room environment (e.g., one or more of a table, a drape, and a patient). The endovascular management and tracking system may further include a fastener configured to secure a distal end of the flexible track to the patient. In one embodiment, the drive assembly includes at least one axial drive mechanism and at least one first actuator. Each of the shuttles includes an axial drive mechanism and at least one first actuator. Each of the axial drive mechanisms can be configured to be actuated to axially translate a respective shuttle along the flexible track, and each of the first actuators can be configured to actuate a respective axial drive mechanism. In this embodiment, the drive assembly may further include at least one rotational drive mechanism and at least one second actuator. Each of the shuttles includes a rotational drive mechanism and at least one second actuator. Each of the rotational drive mechanisms can be configured to be actuated to rotate a respective elongated medical instrument about its longitudinal axis relative to a respective shuttle, and each of the second actuators can be configured to actuate a respective rotational drive mechanism. In this embodiment, the endovascular management and tracking system may further include a locking mechanism configured to be manually operated to alternately engage and disengage the axial drive mechanism from the flexible track.

[0017] In one embodiment, the endovascular management and tracking system further comprises a plurality of track support arms. Each of the plurality of track support arms has one end configured to be secured to a procedure table and an opposite end configured to be secured to the track such that the track is suspended above the procedure table. In this embodiment, each of the plurality of track support arms can be configured to be adjusted relative to the procedure table to select a height of the opposite end of the respective arm relative to the procedure table. In this embodiment, the endovascular management and tracking system can further include a plurality of legs attached to the opposite ends of the plurality of track support arms, and the flexible track can be configured to be attached on the plurality of legs. Each of the plurality of legs can be configured to be adjusted relative to the track support arm to select a height of the respective leg relative to the procedure table. The flexible track can include a channel along a length of the flexible track, and each of the plurality of legs can include a cleat configured to be removably attached to the channel of the flexible track.

[0018] In another embodiment, the flexible track includes a track rack configured to rest stably on the drape and a track rail attached to the track rack such that the track rail is elevated above the drape. The shuttle is configured to be mechanically coupled to the track rail. In this embodiment, the track rack may include an elongated base configured to rest stably on the drape and one or more pedestals mounted on the elongated base to which the track rail is secured. The elongated base may be in the form of a rectangular frame having a pair of elongated frame members and a series of cross bars that secure the pair of elongated frame members to one another.

[0019] In yet another embodiment, the endovascular management and tracking system includes a plurality of shuttles to which a plurality of elongated medical instruments are respectively attached. In this embodiment, each of the plurality of shuttles may be configured to be removably mechanically coupled to the flexible track, e.g., threaded or transversely fitted to the flexible track. In this embodiment, each trailing one of the plurality of shuttles is configured to slidably receive a distal end of a respective one of the plurality of elongated medical instruments attached to a leading one of the plurality of shuttles, such that each elongated medical instrument attached to the leading shuttle is coaxially disposed within each one of the plurality of elongated medical instruments attached to the trailing shuttle. In an optional embodiment, one of the plurality of shuttles may be a master shuttle and another one of the plurality of shuttles may be a slave shuttle. In this embodiment, the endovascular management and tracking system further includes a controller (e.g., an electrical controller or a mechanical controller) configured to actuate an axial drive mechanism of the slave shuttle in response to actuation of an axial drive mechanism of the master shuttle, such that the slave shuttle moves axially along the flexible track in synchronization with the axial movement of the master shuttle along the flexible track.

[0020] In yet another embodiment, each of the shuttles further includes an on-board fluid management and control assembly carried by the sled and configured to be fluidly coupled to an elongated medical instrument attached to the respective shuttle, In this embodiment, the on-board fluid management and control assembly may include a rotating hemostasis valve (RHV) configured to be removable from the respective shuttle.

[0021] In yet another embodiment, each of the elongate medical instruments is flexible, and each of the one or more shuttles further includes an anti-buckling mechanism configured to prevent the respective elongate medical instrument from prolapsing in response to axial compression applied to the respective elongate medical instrument. Each of the anti-buckling mechanisms may include a tubular member configured to have the respective elongate medical instrument slidably disposed therein. Such a tubular member may have a slit extending along the length of the tubular member. In this embodiment, the distal end of each of the anti-buckling mechanisms may be configured to be fixed in a predetermined position, and each of the anti-buckling mechanisms may be configured to lengthen as the respective shuttle moves axially away from the position and to shorten as the respective shuttle moves axially toward the position. The position at which the distal end of one of the anti-buckling mechanisms is fixed may be a fixed position relative to the patient. If the endovascular management and tracking system includes multiple shuttles, the position at which the distal end of the anti-buckling mechanism of a leading one of the multiple shuttles is attached may be a trailing one of the multiple shuttles. In one embodiment, the anti-buckling mechanism includes a driver assembly.

[0022] The robotic endovascular system may include the endovascular management and tracking system described above, and a master input device configured to receive manual commands from a user and send control signals to the motors of each shuttle. In the robotic endovascular system, each of the shuttles may optionally include a manual actuator configured to actuate an axial drive mechanism.

[0023] According to a third aspect of the invention, an intravascular management and tracking system includes a driver system (e.g., manually or motor-operated) configured to axially translate at least one flexible elongate medical instrument (e.g., a guide sheath, a working catheter, and / or a guidewire) and, optionally, rotate each of the flexible elongate medical instruments about its longitudinal axis. The intravascular management and tracking system further includes at least one anti-buckling mechanism configured to prevent one of the respective elongate medical instruments from prolapsing in response to axial compression applied to the respective elongate medical instrument. Each of the anti-buckling mechanisms includes an axially split sheath configured to be alternately furled and unfurled in response to axial movement of the respective elongate medical instrument. The axially split sheath has a flattened proximal portion configured to assume a flattened state when rolled, a tubular distal portion configured to assume a tubular state when unfurled, and a lumen configured to slidably receive the respective elongate medical instrument therein in the tubular distal portion.

[0024] In one embodiment, the axially split sheath is preformed to assume a tubular shape such that the flattened proximal portion of the axially split sheath only assumes a flattened state in response to an external force, hi another embodiment, the axially split sheath has a bistable structure such that the flattened proximal portion of the axially split sheath remains flat in the absence of an external force and the tubular distal portion of the axially split sheath remains tubular in the absence of an external force.

[0025] In yet another embodiment, the endovascular management and tracking system further includes a flattening mechanism configured to transition the axially split sheath from a tubular state to a flattened state such that a flattened proximal portion of the axially split sheath extends proximally from the flattening mechanism. By way of example, the flattening mechanism may include pinch rollers between which the axially split sheath is disposed. In this embodiment, the endovascular management and tracking system may further include a tube forming mechanism configured to transition the axially split sheath from the flattened state to a tubular state. The tube forming mechanism may be disposed distal to the flattening mechanism such that an axially split tubular distal portion extends distally from the tube forming mechanism. The tube forming mechanism may include an arcuate abutment surface against which the axially split sheath abuts.

[0026] In yet another embodiment, each of the anti-buckling mechanisms further comprises a take-up reel disposed within the housing. The take-up reel is configured to alternately take up the flattened proximal portion of the axially split sheath when winding and to unfold the flattened proximal portion of the axially split sheath when unwinding. Each of the anti-buckling mechanisms may further comprise a take-up biasing mechanism configured to bias the take-up reel to take up the flattened proximal portion of the axially split sheath when winding. In one example, the take-up biasing mechanism may comprise a tension spring attached to the take-up reel to apply a constant tension to the flattened proximal portion of the axially split sheath. In another example, the take-up biasing mechanism may comprise a motor mechanically coupled to the take-up reel to apply a constant tension to the flattened proximal portion of the axially split sheath.

[0027] In another embodiment, the take-up biasing mechanism may include an idler pulley attached to the take-up reel such that the take-up reel rotates in unison with the idler pulley, a drive pulley configured to rotate when winding up the flattened proximal portion of the axially split sheath, and a drive belt coupling the idler pulley to the drive pulley such that the idler pulley rotates in response to rotation of the drive pulley. The diameter of the idler pulley may be smaller than the diameter of the drive pulley. The idler pulley may optionally be ratcheted such that the idler pulley spins free when the take-up reel spreads the flattened proximal portion of the axially split sheath. In this embodiment, the take-up biasing mechanism may further include a clutch mechanism (e.g., a friction clutch between the idler pulley and the drive belt) configured to match a linear speed of the flattened proximal portion of the axially split sheath wound on the take-up reel to a linear speed of the tubular distal portion of the axially split sheath relative to the housing. In this embodiment, the winding biasing mechanism may further include pinch rollers between which the axially split sheath is frictionally disposed such that the pinch rollers rotate as the axially split sheath is wound up, in which case a pulley may be fixed to one of the pinch rollers such that a drive pulley rotates integrally with one of the pinch rollers.

[0028] In yet another embodiment, the endovascular management and tracking system further comprises a track (which may or may not be flexible), and the drive system comprises at least one shuttle configured to be mechanically coupled to the track. In this embodiment, each of the shuttles comprises a sled configured to have a respective one of the elongated medical instruments attached thereto, an axial drive mechanism carried by the sled and configured to be actuated to axially translate the respective shuttle along the track, and a first actuator carried by the sled and configured to actuate the axial drive mechanism. Each of the shuttles may optionally include a rotational drive mechanism carried by the sled and configured to be actuated to rotate the respective elongated medical instrument about its longitudinal axis, and a second actuator (e.g., a manual actuator or a motor) carried by the sled and configured to actuate the rotational drive mechanism. Each of the anti-buckling mechanisms is carried by the sled and configured to prevent the respective elongated medical instrument from prolapsing in response to axial compression applied to the respective elongated medical instrument.

[0029] In this embodiment, the endovascular management and tracking system may include a plurality of shuttles to which a plurality of elongated medical instruments are respectively attached. Each of the plurality of shuttles may be configured to be removably mechanically coupled to the track, e.g., threaded or transversely fitted to the track. Each trailing one of the plurality of shuttles is configured to slidably receive a distal end of a respective one of the plurality of elongated medical instruments attached to a leading one of the plurality of shuttles, such that each elongated medical instrument attached to the leading shuttle is coaxially disposed within each one of the plurality of elongated medical instruments attached to the trailing shuttle. In an optional embodiment, one of the plurality of shuttles may be a master shuttle and another one of the plurality of shuttles may be a slave shuttle. In this embodiment, the endovascular management and tracking system further includes a controller (e.g., an electrical controller or a mechanical controller) configured to actuate an axial drive mechanism of the slave shuttle in response to actuation of the axial drive mechanism of the master shuttle, such that the slave shuttle moves axially along the track in synchronization with the axial movement of the master shuttle along the track.

[0030] In this embodiment, each of the shuttles may further include an on-board fluid management control assembly carried by the sled and configured to be fluidly coupled to an elongated medical instrument attached to the respective shuttle. The on-board fluid management control assembly may include a rotating hemostasis valve (RHV) configured to be removable from the respective shuttle. In this embodiment, the endovascular management and tracking system may further include a locking mechanism carried by the sled and configured to be manually operated to alternately engage and disengage the axial drive mechanism from the track. In this embodiment, the endovascular management and tracking system may further include a locking mechanism carried by the sled and configured to be manually operated to alternately engage and disengage the axial drive mechanism from the track.

[0031] In this embodiment, the distal end of each of the anti-buckling features may be configured to be fixed in a predetermined position, and each of the anti-buckling features may be configured to lengthen as the respective shuttle moves axially away from the position and shorten as the respective shuttle moves axially toward the position. The position at which the distal end of one of the anti-buckling features is fixed may be a fixed position relative to the patient. If the endovascular management and tracking system includes multiple shuttles, the position at which the distal end of the anti-buckling feature of a leading one of the multiple shuttles is attached may be a trailing one of the multiple shuttles. In one embodiment, the anti-buckling features include a driver system.

[0032] The robotic endovascular system may include the endovascular management and tracking system described above, and a master input device configured to receive manual commands from a user and send control signals to the motors of each shuttle. In the robotic endovascular system, each of the shuttles may optionally include a manual actuator configured to actuate an axial drive mechanism.

[0033] According to a fourth aspect of the invention, an intravascular management and tracking system includes a track (which may or may not be flexible), a slave shuttle to which a first elongated medical instrument may be attached, and a master shuttle to which a second elongated medical instrument may be attached. The slave shuttle and the master shuttle are configured to be mechanically coupled to the track. In one embodiment, each of the master shuttle and the slave shuttle is configured to be removably mechanically coupled to the track. In another embodiment, one of the master shuttle and the slave shuttle is a trailing shuttle and the other of the master shuttle and the slave shuttle is a leading shuttle, and the master shuttle is configured to receive a distal end of one of the first and second elongated medical instruments attached to the leading shuttle such that each of the elongated medical instruments attached to the leading shuttle is coaxially disposed within each of the first and second elongated medical instruments attached to the trailing shuttle. In yet another embodiment, each of the first and second elongate medical instruments is flexible, in which case each of at least one of the master shuttle and the slave shuttle further comprises an anti-buckling mechanism configured to prevent the respective elongate medical instrument from prolapse in response to axial compression applied to the respective elongate medical instrument.

[0034] The endovascular management and tracking system further comprises a first axial drive mechanism configured to be operated to axially translate the slave shuttle along the track. In one embodiment, the master shuttle further comprises a sled configured to run on the track, and the first axial drive mechanism and the manual actuator are carried on the sled. The endovascular management and tracking system further comprises a controller configured to actuate the first axial drive mechanism in response to manual axial movement of the master shuttle along the track, where the slave shuttle moves axially along the track in synchrony with the axial movement of the master shuttle along the track. In any embodiment, the slave shuttle can include a first rotational drive mechanism configured to be operated to rotate the first elongated medical instrument about its longitudinal axis relative to the slave shuttle, and the master shuttle can include a second rotational drive mechanism configured to be operated to rotate the second elongated medical instrument about its longitudinal axis relative to the master shuttle.

[0035] In one embodiment, the controller is an electrical controller. In this embodiment, the endovascular management and tracking system may further include an encoder indicative of a position of the master shuttle relative to the track, and one or more sensors configured to read the encoder and output an electrical signal indicative of a position of the master shuttle relative to the track. The electrical controller may be configured to control the first axial drive mechanism based on the electrical signal. The encoder may be disposed along the track, and the sensor may be disposed on the master shuttle. In this case, the encoder may include a series of fiducial elements extending along the length of the track, and the sensor may include a fiducial element reader configured to read the fiducial elements.

[0036] In another embodiment, the controller is a mechanical controller. In this embodiment, the slave shuttle may further include a first sled configured to ride on the track, and the master shuttle may further include a second sled configured to ride on the track. The first axial drive mechanism may be carried on the first sled and configured to be actuated to axially translate the slave shuttle along the track, and the second axial drive mechanism may be carried on the second sled and configured to be actuated to axially translate the master shuttle along the track. The master shuttle may further include a manual actuator carried on the second sled and configured to actuate the second axial drive mechanism, and the slave shuttle may further include another manual actuator carried on the first sled and configured to actuate the first axial drive mechanism. The mechanical controller may include a control shaft mechanically coupled (e.g., in a detachable manner) between the first and second axial drive mechanisms.

[0037] The control shaft may be configured to be mechanically coupled between the first and second axial drive mechanisms, where the control shaft and one of the slave shuttle and the master shuttle are configured to be axially translated together, while the control shaft and the other of the slave shuttle and the master shuttle are configured to be axially translated relative to one another. In this case, the control shaft may be configured to rotate about its longitudinal axis in response to actuation of the second axial drive mechanism, and the first axial drive mechanism may be configured to actuate in response to rotation of the control shaft about its longitudinal axis. The first axial drive mechanism may include a first worm drive, the second axial drive mechanism may include a second worm drive, and the control shaft may be operably coupled between the first worm drive and the second worm drive. The first worm drive may be removably disposed within the slave shuttle. The first worm drive can include a first worm screw and a first worm gear, the second worm drive can include a second worm screw and a second worm gear, the control shaft can be operably coupled between the first and second worm screws, the first worm gear can be operably coupled between the first manual actuator and the first worm screw, and the second worm gear can be operably coupled between the second worm screw and the track. Also, each of the first worm screw and the second worm screw can have a bore configured to have the control shaft disposed therethrough, and the bores of the first worm screw and the second worm screw and the outer circumferential surface of the control shaft can be keyed. The master shuttle can further include a rotatable manual actuator carried on the sled and configured to actuate the second axial drive mechanism, and the second worm gear can be operably coupled between the rotatable manual actuator and the track. The first worm screw and the second worm screw may have different and / or opposite pitches.

[0038] In yet another embodiment, the slave shuttle is translated axially along the track in synchrony with the axial translation of the master shuttle along the track according to an axial translation ratio. The axial translation ratio may be a negative axial translation ratio or a positive axial translation ratio. When the axial translation ratio is a negative axial translation ratio, one of the first and second elongate medical instruments may be a stent deployment catheter and the other of the first and second elongate medical instruments may be a pusher member disposed within the stent deployment catheter and attached to a stent within the stent deployment catheter. When the axial translation ratio is a positive axial translation ratio and is unity, the slave shuttle may translate axially along the track in synchrony with the axial translation of the master shuttle along the track at a predetermined distance from the master shuttle. The slave shuttle may not translate axially along the track as the master shuttle translates axially along the track until the slave shuttle is a predetermined distance from the master shuttle. In this case, the first elongate medical device may be a catheter and the second elongate medical device may be a guidewire, or the first elongate medical device may be a stent driver and the second elongate medical device may be a catheter.

[0039] According to a fifth aspect of the present invention, there is provided a control station for use with a robotic endovascular management and tracking system configured to axially translate and robotically rotationally move a plurality of elongated medical instruments of a coaxial endovascular assembly.

[0040] The control station comprises a master input device including a linear array of control elements configured to be manually moved axially along the longitudinal axis and manually moved rotationally about the longitudinal axis. In one embodiment, each control element is cylindrical. In another embodiment, the cylindrical control elements have different diameters. The control station further comprises at least one processor configured to operably couple each of the linear array of control elements to the elongated medical device by instructing the robotic endovascular management and tracking system to axially translate each of the elongated medical devices in response to manual axial translation of each of the linear array of control elements along the longitudinal axis and to rotationally translate each of the elongated medical devices in response to manual rotational translation of each of the linear array of control elements about the longitudinal axis.

[0041] In any embodiment, the claimed control station further comprises at least one force feedback sensor configured to detect a force exerted on each of the elongate medical instruments as they are advanced within the patient's vasculature, and a haptic interface configured to communicate haptic feedback to an operator's hand when an operator manually translates axially and manually rotates each of the control elements. In one example, the haptic interface is configured to communicate haptic feedback to the operator's hand via the master input device. In another example, the haptic interface includes one or more haptic feedback gloves. In yet another example, the haptic interface includes one or more ultrasound pads.

[0042] In one embodiment, the master input device comprises a rail and the control element is a physical control element slidably disposed axially and rotationally on the rail.

[0043] In an embodiment having physical control elements, the control station may further include a sensor assembly configured to detect manual axial movement of each of the control elements along the longitudinal axis, detect manual rotational movement of each of the control elements about the longitudinal axis, output a signal indicative of the detected axial movement of each of the control elements along the longitudinal axis, and output a signal indicative of the detected rotational movement of each of the control elements about the longitudinal axis. The processor may be configured to instruct the robotic endovascular management and tracking system to axially translate and rotationally translate each of the elongated medical instruments in response to the control signal output by the sensor assembly. In this embodiment, the sensor assembly may include a passive component and at least one active component, where the passive component is affixed to the control element and the active component may be located remotely from the control element. The sensor assembly may include a plurality of active components each mounted in a rail adjacent to a passive component. In one example, the passive component includes a reference element mounted on a periphery of each of the control elements. In another example, the passive components include a plurality of passive electromagnetic transponders each attached to the control element and the active components include an electromagnetic transceiver. In yet another example, the control station further comprises a sensor box including the active components, the passive components including a plurality of mechanical arms cantilevered on the control element, the free ends of the mechanical arms configured to operatively interact with at least one active component in the sensor box.

[0044] In this embodiment, the control station may further include a plurality of disposable sterile control element covers configured to slide the control elements into position, respectively, The sterile control element covers may be configured to overlap one another such that a sliding fluid seal is formed between adjacent control elements to prevent transfer of contaminating fluids between adjacent control elements.

[0045] In another embodiment, the control element is a virtual control element.The control station may further include a gesture monitoring system configured to capture hand gestures made by the operator while virtually interacting with the virtual control element.

[0046] In an embodiment having a virtual control element, the master input device may include a three-dimensional (3D) touchscreen configured to display an interactive 3D representation of the virtual control element. In this case, the 3D touchscreen may have an arc-shaped cross section and the virtual control element may be arc-shaped. For example, the 3D touchscreen may be cylindrical and the virtual control element may be cylindrical. In another embodiment having a virtual control element, the control station may further include a head-mounted augmented reality (XR) system configured to display the virtual control element in a three-dimensional (3D) environment. In yet another embodiment having a virtual control element, the control station may further include a two-dimensional (2D) display screen configured to display the virtual control element. In yet another embodiment with a virtual control element, the control station may further include a holographic machine configured to project the virtual control element into the three-dimensional (3D) environment.

[0047] A robotic endovascular system may include the control station and the robotic endovascular management and tracking system described above. In one embodiment, the robotic endovascular management and tracking system includes a track and a plurality of shuttles to which a plurality of elongated medical instruments are respectively attached. Each of the shuttles includes a sled configured to be mechanically coupled to the track and configured to ride on the track, an axial drive mechanism carried by the sled and configured to be actuated to axially translate a respective shuttle along the track, a first axial motor carried by the sled and configured to actuate the axial drive mechanism, a rotational drive mechanism carried by the sled and configured to be actuated to rotate a respective elongated medical instrument about its longitudinal axis, and a second motor carried by the sled and configured to actuate the rotational drive mechanism.

[0048] Other and further aspects and features of the embodiments will become apparent from the following detailed description considered in conjunction with the accompanying figures. [Brief description of the drawings]

[0049] The drawings illustrate the design and utility of preferred embodiments of the present invention, with similar elements being referred to by common reference numerals. It should be noted that the drawings are not drawn to scale, and that elements having similar structures or functions are represented by similar reference numerals throughout the drawings. It should also be noted that the drawings are intended to facilitate the description of the embodiments. They are not intended to be exhaustive descriptions of the present invention, or to limit the scope of the present invention, which is defined only by the appended claims and their equivalents. Furthermore, illustrated embodiments of the disclosed invention need not have all the aspects or advantages illustrated. Aspects or advantages discussed in connection with a particular embodiment of the disclosed invention are not necessarily limited to that embodiment, and may be implemented in other embodiments, even if not illustrated. To better understand how the above and other advantages and objects of the present invention are obtained, the brief description of the present invention set forth above will be more particularly described by reference to specific embodiments illustrated in the accompanying drawings. The present invention will be described with more specificity and detail with the accompanying drawings, with the understanding that these drawings depict only exemplary embodiments of the present invention, and therefore are not intended to limit its scope. [Figure 1] FIG. 1 is a side view of one embodiment of a robotic endovascular system constructed in accordance with the present invention. [Diagram 2] FIG. 2 is a top view of the robotic endovascular system of FIG. [Diagram 3] 3 is a top view of a catheter assembly of the robotic intravascular system of FIG. [Figure 4] FIG. 4 is a cross-sectional view of the catheter assembly of FIG. 3 taken along line 4-4. [Diagram 5]5 is a plan view of a proximal adapter of a guide sheath or working catheter of the catheter assembly of FIG. 4. FIG. [Figure 6] FIG. 6 is a plan view of one embodiment of an endovascular management and tracking system of the robotic endovascular system of FIG. [Figure 7] 7A-7D are various views of one embodiment of a shuttle of the intravascular management and tracking system of FIG. [Figure 8] FIG. 8 is a plan view of the rotary hemostatic valve (RHV) of the shuttle of FIGS. 7A-7D. [Figure 9] FIG. 9 is a perspective view of an axially split sheath of the buckling prevention mechanism of the shuttle of FIGS. 7A to 7D. [Figure 10] FIG. 10 is a cross-sectional view of the axially split sheath of FIG. 9 taken along line 10-10. [Figure 11] 11A-11D are plan views of the intravascular management and tracking system of FIG. 6, particularly illustrating different relative axial positions of the shuttle and the resulting varying length of the axially split sheath of FIG. [Figure 12] 12A to 12D are plan views showing different structures of the buckling prevention mechanisms of the shuttles of FIGS. 7A to 7D. [Figure 13A] FIG. 13A is a top view of an alternative embodiment of an anti-buckling feature that can be used in the shuttles of FIGS. 7A-7D, particularly showing the anti-buckling feature in a fully extended position. [Figure 13B] FIG. 13B is a top view of the buckling prevention mechanism of FIG. 13A, specifically showing the buckling prevention mechanism in a fully contracted state. [Figure 14A] FIG. 14A is a top view of another alternative embodiment of an anti-buckling feature that can be used in the shuttles of FIGS. 7A-7D, particularly showing the anti-buckling feature in a fully extended position. [Figure 14B] FIG. 14B is a top view of the buckling prevention mechanism of FIG. 14A, specifically showing the buckling prevention mechanism in a fully contracted state. [Figure 15A]FIG. 15A is a plan view of yet another alternative embodiment of an anti-buckling feature that can be used in the shuttles of FIGS. 7A-7D, particularly showing the anti-buckling feature in a fully extended position. [Figure 15B] FIG. 15B is a top view of the buckling prevention mechanism of FIG. 15A, particularly showing the buckling prevention mechanism in a fully contracted state. [Figure 16A] FIG. 16A is a plan view of yet another alternative embodiment of an anti-buckling feature that can be used in the shuttles of FIGS. 7A-7D, particularly showing the anti-buckling feature in a fully extended position. [Figure 16B] FIG. 16B is a top view of the buckling prevention mechanism of FIG. 16A, specifically showing the buckling prevention mechanism in a fully contracted state. [Figure 17A] FIG. 17A is a plan view of yet another alternative embodiment of an anti-buckling feature that can be used in the shuttles of FIGS. 7A-7D, particularly showing the anti-buckling feature in a fully extended position. [Figure 17B] FIG. 17B is a top view of the buckling prevention mechanism of FIG. 17A, specifically showing the buckling prevention mechanism in a fully contracted state. [Figure 18] FIG. 18 is a top view of one embodiment of a control station of the robotic endovascular system of FIG. 1, particularly illustrating one embodiment of a sterile sleeve that covers the master input device of the control station. [Figure 18A] FIG. 18A is a plan view of one particular embodiment of the control station of FIG. [Figure 18B] FIG. 18B is a plan view of another specific embodiment of the control station of FIG. [Figure 18C] FIG. 18C is a plan view of yet another specific embodiment of the control station of FIG. [Figure 18D] FIG. 18D is a plan view of yet another specific embodiment of the control station of FIG. [Figure 18E] FIG. 18E is a perspective view of a control element used in the control station of FIG. 18D. [Figure 18F]FIG. 18F is an axial view of the mechanical arms arranged on the control element of FIG. 18E, specifically showing the mechanical arms arranged clockwise relative to one another. [Figure 18G] FIG. 18G is a plan view of yet another specific embodiment of the control station of FIG. [Figure 18H] FIG. 18H is a plan view of yet another specific embodiment of the control station of FIG. [Figure 18I] FIG. 18I is a plan view of yet another specific embodiment of the control station of FIG. [Figure 18J] FIG. 18J is a plan view of yet another specific embodiment of the control station of FIG. [Figure 18K] FIG. 18K is a plan view of yet another specific embodiment of the control station of FIG. [Figure 18L] FIG. 18L is a plan view of yet another specific embodiment of the control station of FIG. [Figure 19] FIG. 19 is a top plan view of the control station of FIG. 18, particularly illustrating another embodiment of a plurality of sterile sleeves covering the master input devices of the control station. [Figure 20] FIG. 20 is a top view of a plurality of the sterile sleeves of FIG. 19 stacked for storage. [Figure 21] 21 is a perspective view of another embodiment of an endovascular management and tracking system of the robotic endovascular system of FIG. [Figure 22] 22 is a side view of the intravascular management and tracking system of FIG. 21. [Diagram 23] 23 is a top view of the intravascular management and tracking system of FIG. 21. [Figure 24] 24 is a bottom view of the intravascular management and tracking system of FIG. 21. [Diagram 25] 25 is a perspective view of a track segment of the intravascular management and tracking system of FIG. 21. [Figure 26] FIG. 26 is a side view of the track segment of FIG. [Figure 27] FIG. 27 is a top view of the track segment of FIG. [Figure 28] FIG. 28 is a front view of the track segment of FIG. [Figure 29] FIG. 29 is a rear view of the track segment of FIG. [Diagram 30] 30 is a perspective view showing the interaction of the shuttle sled with the track segments of the intravascular management and tracking system of FIG. 21. [Diagram 31] FIG. 31 is a perspective view of the shuttle of the intravascular management and tracking system of FIG. 21, specifically showing the upper casing portion removed from the shuttle. [Diagram 32] FIG. 32 is another perspective view of the shuttle of FIG. 31, particularly showing the upper casing portion removed from the shuttle. [Diagram 33] FIG. 33 is yet another perspective view of the shuttle of FIG. 31, particularly showing the upper casing portion and RHV removed therefrom to expose the axial drive mechanism of the shuttle. [Diagram 34] FIG. 34 is yet another perspective view of the shuttle of FIG. 31 , specifically showing the upper casing portion, sled, and RHV removed from the shuttle to expose the axial drive mechanism of the shuttle, which has been disengaged from the track. [Diagram 35] FIG. 35 is yet another perspective view of the shuttle of FIG. 31 , specifically showing the upper casing portion, sled, and RHV removed therefrom to expose the axial drive mechanism of the shuttle, which is engaged with the track. [Diagram 36] 36 is an exploded perspective view of the axial drive mechanism of the shuttle of FIG. 21; FIG. [Figure 37] 37 is an enlarged perspective view of the axial drive mechanism of the shuttle of FIG. 21; FIG. [Figure 38] 38 is a side view of the axial drive mechanism of FIG. 37. FIG. [Figure 39] 39 is a top view of the axial drive mechanism of FIG. 37. FIG. [Diagram 40] FIG. 40 is a perspective view of the shuttle of FIG. 21, particularly showing the rotary drive mechanism of the shuttle. [Diagram 41] FIG. 41 is a front view of the shuttle of FIG. 21, particularly showing the rotary drive mechanism. [Diagram 42] FIG. 42 is a bottom view of the upper casing and RHV of the shuttle of FIG. [Diagram 43] 43 is a bottom view of the upper casing of the shuttle of FIG. 21. FIG. [Diagram 44] FIG. 44 is a perspective view of one embodiment of an anti-buckling mechanism for the shuttle of FIG. [Diagram 45] FIG. 45 is another perspective view of the anti-buckling mechanism of FIG. [Figure 46] FIG. 46 is a top view of the buckling prevention mechanism of FIG. [Figure 47] FIG. 47 is a side view of the anti-buckling mechanism of FIG. [Figure 48] FIG. 48 is another side view of the anti-buckling mechanism of FIG. [Figure 49] FIG. 49 is a top view of the anti-buckling mechanism of FIG. 44, particularly showing the optional take-up biasing mechanism. [Figure 50] FIG. 50 is a schematic diagram of the buckling prevention mechanism of FIG. 44, and in particular illustrates the matching of the linear velocity of the axially split sheath of the buckling prevention mechanism with the linear velocity of the take-up reel of the buckling prevention mechanism. [Figure 51] FIG. 51 is a perspective view showing another embodiment of the anti-buckling mechanism of the shuttle of FIG. [Figure 52] FIG. 52 is another perspective view of the anti-buckling mechanism of FIG. 51. [Figure 53] FIG. 53 is a side view of the anti-buckling mechanism of FIG. [Figure 54] FIG. 54 is a bottom view of the anti-buckling mechanism of FIG. [Figure 55] FIG. 55 is a top view of the anti-buckling mechanism of FIG. [Figure 56]FIG. 56 is a schematic diagram of yet another embodiment of an endovascular management and tracking system of the robotic endovascular system of FIG. [Figure 57] FIG. 57 is a top view of a motorized version of the intravascular management and tracking system of FIG. 56. [Figure 58] 58 is a top view of a manually operated version of the intravascular management and tracking system of FIG. 56. [Figure 59] 59 is a cross-sectional view of the control shaft and worm screw of the axial drive mechanism of the shuttle of the intravascular management and tracking system of FIG. 58. [Figure 60A] FIG. 60A is a plan view of one configuration of the intravascular management and tracking system of FIG. 56 for use with a stent delivery catheter and pusher wire. [Figure 60B] FIG. 60B is a plan view of the intravascular management and tracking system of FIG. 60A, particularly illustrating the deployment of a stent from a stent delivery catheter. [Figure 60C] FIG. 60C is a plan view of the intravascular management and tracking system of FIG. 60A, specifically illustrating the re-covering of a stent within a stent delivery catheter. [Figure 60D] FIG. 60D is a plan view showing another configuration of the intravascular management and tracking system of FIG. 56, particularly illustrating the deployment of a stent from a stent delivery catheter. [Figure 60E] FIG. 60E is a plan view showing yet another configuration of the intravascular management and tracking system of FIG. 56, particularly illustrating the deployment of a stent from a stent delivery catheter. [Figure 61A] FIG. 61A is a plan view showing one configuration of the intravascular management and tracking system of FIG. 56 for use with a catheter and guidewire. [Figure 61B] FIG. 61B is a plan view of the intravascular management and tracking system of FIG. 61A, particularly showing distal advancement of the catheter and guidewire. [Figure 61C] FIG. 61C is a plan view of the intravascular management and tracking system of FIG. 61A, particularly showing proximal retraction of the catheter and guidewire. [Figure 62A]FIG. 62A is a plan view showing one configuration for use of the intravascular management and tracking system of FIG. 56 with a catheter and stent liver. [Figure 62B] FIG. 62B is a plan view of the endovascular management and tracking system of FIG. 62A, particularly showing the proximal retraction of the thrombus-trapping stent river. [Figure 62C] FIG. 62C is a plan view of the endovascular management and tracking system of FIG. 61A, particularly showing proximal retraction of the catheter and stent liver. [Figure 63] 63 is a perspective view of yet another embodiment of an endovascular management and tracking system of the robotic endovascular system of FIG. 1. [Figure 64] FIG. 64 is an enlarged perspective view of the intravascular management and tracking system of FIG. 63. [Figure 65] FIG. 65 is an enlarged perspective view of the intravascular management and tracking system of FIG. 63, particularly showing the fastening of the track to the support arm of the intravascular management and tracking system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0050] 1-2, one embodiment of a robotic endovascular system 10 constructed in accordance with the present invention will be described. The robotic endovascular system 10 generally includes an endovascular assembly 12 (best shown in FIG. 3), an endovascular management and tracking system 14 that may be intimately associated with a procedure table 18 on which a patient 20 (which in the illustrated embodiment is a human, but which may be any animal) is positioned and to which the endovascular assembly 12 is operably mounted in a coaxial (or nested) relationship, and a control station 16 communicatively coupled to the endovascular management and tracking system 14, thereby enabling an operator 24 (e.g., a physician) to perform a medical procedure on the patient 20. The robotic endovascular system 10 may also include a drape 22 (shown in phantom in FIG. 2) that at least partially covers the procedure table 18 and the patient 20.

[0051] 3-4, the endovascular assembly 12 includes a plurality of elongated medical instruments 26, in this example a guide sheath 26a, a working catheter 26b, and a guidewire 26c arranged coaxially with one another, i.e., the guidewire 26c is sized to be slidably received within the working catheter 26b, and the working catheter 26b is sized to be slidably received within the guide sheath 20. The endovascular assembly 12 may be inserted, for example, through a natural body lumen, such as a blood vessel (artery, ventricle, or vein), urinary system vessels (renal collecting duct, renal calyx, ureter, bladder, or urethra), hepatobiliary system vessels (hepatic and pancreatic ducts, bile duct, common or vesical duct), gastrointestinal tract (esophagus, stomach, small intestine, large intestine, cecum, rectum), gynecological tract (cervix, uterus), fallopian tubes or lactiferous ducts, lactiferous ducts of the breast, nasopharynx (Eustachian tube, paranasal sinuses, lacrimal duct), seminal vesicles, spinal canal, or ventricles. The endovascular assembly 12 may be introduced into the patient 20 via percutaneous access, surgical access, or a natural orifice, such as the oral cavity, rectum, nasal cavity, Eustachian tube, optic canal, or urethra.

[0052] Although the endovascular assembly 12 is described herein as including a triaxial structure of a guide sheath, a working catheter, and a guidewire with which the endovascular management and tracking system 14 interacts, it should be understood that the endovascular assembly 12 may include any combination of a guide sheath, a working catheter, and a guidewire with which the endovascular management and tracking system 14 interacts, a biaxial structure, or even a single-axial structure (i.e., only one of the guide sheath, working catheter, guidewire, or other flexible, elongated medical device with which the endovascular management and tracking system 14 interacts).

[0053] Guide sheath 26a is configured to facilitate access of working catheter 26b to a target tissue site within the vasculature of patient 20. Guide sheath 26a generally includes an elongate sheath body 28 having a proximal end 30 and a distal end 32, a central lumen 34 (best seen in FIG. 4 ) extending generally through sheath body 28 between proximal end 30 and distal end 32, and a proximal adapter 36 attached to the proximal end 30 of sheath body 28.

[0054] The sheath body 28 is substantially soft or flexible such that an operator or surgeon can easily manipulate the sheath body 28 to follow, conform, or match the shape and curvature of the patient's internal passageway (e.g., gastrointestinal tract, blood vessels, etc.) during advancement within the patient 20. In the embodiment shown in FIG. 6, the sheath body 28 is introduced into the patient 20 via an arterial access sheath 78 and its proximal end is secured to the patient 20 via a sheath anchor 80 having an introduction / removal port 82 through which the sheath body 28 can be introduced or removed from the sheath anchor 80, although the arterial access sheath 78 is not required if the sheath body 28 is introduced into the patient 20 via a natural orifice.

[0055] In the illustrated embodiment, the sheath body 28 has a circular cross-section, although other cross-sectional shapes, such as rectangular, may be used. The sheath body 28 may be constructed of multiple layers of material and / or multiple tube structures that provide high axial stiffness along the neutral axis while exhibiting low bending stiffness. Typical designs include a braided plastic composite structure made of a nitinol spine wrapped in braid and a flexible, bendable, or suitable polymeric material, or a biocompatible polymeric material, or a low durometer plastic (e.g., Nylon-12, Pebax®, polyurethane, polyethylene, etc.).

[0056] The shape and size of the central lumen 34 is selected depending on the cross-sectional shape and size of the working catheter 26b. The sheath body 28 may have a low friction inner layer (e.g., a silicone or polytetrafluoroethylene coating) to provide a low friction surface to accommodate movement of the working catheter 26b within the working lumen 34 of the guide sheath 26a. As described in further detail below, the proximal adapter 36 is configured to mechanically and fluidly couple the guide sheath 26a to the endovascular management and tracking system 14.

[0057] In any embodiment, the guide sheath 26a may have active steering capabilities such that the distal end 32 of the sheath body 28 may be articulated into simple or complex shapes or curvatures that may conform to various shapes or curvatures of the patient's internal pathways to reach a target tissue site within the vasculature of the patient 20. For example, the guide sheath 26a may have one or more steering elements (such as pull wires (not shown)) extending through the sheath body 28 that are manipulable to impart a desired shape or curvature to the distal end 32 of the sheath body 28.

[0058] The working catheter 26b is configured to perform an interventional and / or diagnostic procedure at a target tissue site. For example, the working catheter 26b can be a stent delivery catheter, a balloon catheter, an electrophysiology catheter, an ultrasound imaging catheter, an atherectomy catheter, a vascular occlusion device delivery catheter, a contrast / drug delivery catheter, etc.

[0059] The working catheter 26b generally includes an elongated catheter body 38 having a proximal end 40 and a distal end 42, a central lumen 44 (best shown in FIG. 4) extending entirely through the catheter body 38 between the proximal end 40 and the distal end 42, a proximal adapter 46 attached to the proximal end 40 of the catheter body 38, and an operating element 48 (e.g., a stent, balloon, mapping electrode, ultrasound element, tissue-cutting blade, vascular occlusion device, fluid port, etc.) carried on the distal end 42 of the catheter body 38.

[0060] The working catheter 26b passes through the central lumen 34 of the guide sheath 26a and is therefore movable relative to the guide sheath 26a. The working catheter 26b may be movably disposed within the central lumen 34 of the guide sheath 26a to permit relative insertion of the guide sheath 26a and the working catheter 26b, relative rotation or "roll" of the guide sheath 26a and the working catheter 26b, and optionally, relative steering or bending of the guide sheath 26a and the working catheter 26b, particularly when the distal end 44 of the catheter body 38 is inserted beyond the distal end 44 of the sheath body 28. As shown in FIG. 3, the working catheter 26b projects distally relative to the distal end 32 of the sheath body 28. Of course, the working catheter 26b can be retracted proximally so that the distal end 44 of the catheter body 38 is substantially flush with the distal end 32 of the sheath body 28, and can also be retracted proximally so that the distal end 32 of the sheath body 28 retracts within the distal end 32 of the sheath body 28.

[0061] The catheter body 38 is substantially flexible or flexible so that it can be advanced through the central lumen 34 of the sheath body 28 when the sheath body 28 conforms to the shape or curvature of the patient's body passageway. In the illustrated embodiment, the catheter body 38 has a circular cross section, although other cross-sectional shapes, such as rectangular, may be used. The catheter body 38 may be constructed of multiple layers of material and / or multiple tubular structures that exhibit low bending stiffness while having high axial stiffness along the neutral axis. Typical designs include braided plastic composite structures made of a nitinol spine wrapped in braid and a flexible, bendable, or suitable polymeric material, or a biocompatible polymeric material, or a low durometer plastic (such as nylon-12, Pebax®, polyurethane, polyethylene, etc.). The catheter body 38 may be constructed of multiple layers of material and / or multiple tubular structures that exhibit low bending stiffness while having high axial stiffness along the neutral axis. Typical designs include a braided plastic composite construction consisting of a nitinol spine wrapped in braid and a flexible, bendable, or suitable polymeric material, or a biocompatible polymeric material, or a low durometer plastic (such as Nylon-12, Pebax®, polyurethane, polyethylene, etc.).

[0062] The shape and size of the central lumen 44 is selected depending on the cross-sectional shape and size of the guidewire 26c. The catheter body 38 may have a low friction inner layer (e.g., a silicone or polytetrafluoroethylene coating) to provide a low friction surface for movement of the guidewire 26c within the central lumen 44 of the working catheter 26b. As described in more detail below, the proximal adapter 56 is configured to mechanically and fluidly couple the working catheter 26b to the endovascular management and tracking system 14.

[0063] In any embodiment, the working catheter 26b may have active steering capabilities such that the distal end 42 of the catheter body 38 may be articulated into simple or complex shapes or curvatures that may conform to various shapes or curvatures of the patient's body passageways to reach a target tissue site within the vasculature of the patient 20. For example, the working catheter 26b may have one or more steering elements, such as pull wires (not shown), extending through the catheter body 38 that are manipulable to impart a desired shape or curvature to the distal end 42 of the catheter body 38.

[0064] Guidewire 26c may be a conventional wire including a guidewire body 50 having a proximal end 52 and a distal end 54, and a collet 56 attached to the proximal end 52 of guidewire body 50. Guidewire body 50 is constructed of a suitable material (e.g., a metal or metal alloy, such as stainless steel and / or nickel titanium alloy, or a polymer) to provide guidewire 26c with the desired flexibility / rigidity characteristics. Guidewire body 50 may have a suitable diameter, for example, 0.125 inches or less, and a suitable length, for example, 50 cm to 350 cm. Collet 56 is configured to mechanically couple guidewire 26c to intravascular management and tracking system 14.

[0065] 5, each of the proximal adapters 36, 46 includes an adapter body 58 made of a suitable material, such as polycarbonate, acrylonitrile butadiene styrene (ABS), acetal, or the like, and a lumen 60 extending axially through the center of the proximal adapter body 58. Each of the proximal adapters 36, 46 further includes a male connector 62 to which the proximal end 30 of the sheath body 28 or the proximal end 40 of the catheter body 38 is suitably attached (e.g., via adhesive) such that the central lumen 34 of the guide sheath 26a or the central lumen 44 of the working catheter 26b is in fluid communication with the lumen 60 of the proximal adapter 36, 46. Each of the proximal adapters 36, 46 may further include a strain relief (not shown) attached to the proximal end 30 of the sheath body 28 or the proximal end 40 of the catheter body 38. The strain relief may be constructed of a suitable material, such as silicone rubber.

[0066] Each of the proximal adapters 36, 46 is designed to allow the guide sheath 26a or working catheter 26b to be removably coupled to the endovascular management and tracking system 14, in this case to a conventional male Touhy-Borst connector of a rotating hemostatic valve (RHV) (described in further detail below) included in the endovascular management and tracking system 14. To this end, each of the proximal adapters 36, 46 further comprises a female luer lock port 64 formed at the proximal end of the proximal adapter body 38. The luer lock port 64 includes at least one external thread 66 and an internal tapered surface 68. In this manner, each of the proximal adapters 36, 46 may be alternately threaded into and unthreaded from the Touhy-Borst connector such that the guide sheath 26a or working catheter 26b may be alternately coupled into and unthreaded from the endovascular management and tracking system 14. Alternatively, each proximal adapter 36 , 46 may be press-fit into a Touhy-Borst connector of the intravascular management and tracking system 14 .

[0067] Returning to FIGS. 1-2, the endovascular management and tracking system 14 is a modular system that sits on a procedure table 18 in the same area where elongated medical instruments are currently handled in conventional endovascular procedures, and uses a flexible track to which multiple sliding shuttles (or drive units) are removably attached. As described in further detail below, the endovascular management and tracking system 14 may provide independent robotic insertion and retraction actuation, robotic rotation or roll actuation, and optional steering actuation to the elongated medical instruments 26 of the coaxial endovascular assembly 12, each coupled to a drive unit, according to control signals transmitted from the control station 16. As described in further detail below, the endovascular management and tracking system 14 can dynamically switch between a fully automated (robotic) modality under the control of the control station 16, and a fully manual modality under manual control of a user without the use of the control station 16. In other embodiments, the endovascular management and tracking system 14 can be operated completely manually in a dedicated manner (i.e., without the use of any motors or controllers), thereby providing a "light" or "cheap" version of the endovascular management and tracking system 14. Operation of the endovascular management and tracking system 14 in a fully manual modality is similar to the operational workflow that may be used in current manual catheter procedures, but additionally provides a more organized working environment, more precise instrument movement, and improved visibility of the elongated medical instruments in use as compared to current manual catheter procedures.

[0068] With further reference to Figures 6 and 7A-7D, the intravascular management and tracking system 14 generally includes a track 70 and a number of shuttles 72 (72a-72c) mechanically coupled to the track 70 and configured for axial translation along the track 70.

[0069] Preferably, the track 70 is sufficiently rigid to support axial movement of the shuttles 72a-72c on the track 70 while being sufficiently flexible to allow the operator 24 or other hospital personnel to conform to the contours of the hospital environment (e.g., the procedure table 18, the patient 20, and / or the drape 22). For example, the track 70 may be highly flexible in the up and down (vertical) direction to conform to the contours of the hospital environment in response to gravity alone (e.g., when placed on the procedure table 18, the patient 20, and / or the drape 22), but relatively less flexible in the lateral (horizontal) and torsional directions to allow the shuttles 72a-72c to apply the necessary driving forces to the track 70 to translate the shuttles 72a-72c axially along the track 70 and to help maintain the orientation and overall position of the track 70 relative to the hospital environment, as described in more detail below. For example, the track 70 may be a ribbon-like element (a wide, thin rectangular extrusion) having a rectangular cross-section, as best shown in FIGS. 7A-7D. In one embodiment, the track 70 is malleable, allowing the track 70 to bend to conform to the patient room environment. As used herein, the term "malleable" with respect to the track 70 means that the shape of the track 70 can be repeatedly changed in response to forces manually applied to the track 70, and that the shape is retained when such forces are removed from the track 70. In another embodiment, rather than a ribbon-like element, the track 70 may be in the form of a helical rod or screw that the shuttles 72a-72c can engage (e.g., using a threaded collar (not shown)). In this case, the track 70 would have a circular cross-section and would therefore have the same flexibility up and down and side to side.

[0070] A fastener (e.g., a leg or arm band / strap, adhesive pad, etc.) can be used to secure a distal end 74 of track 70 at or near an access site on patient 20, while a proximal end 76 of track 70 remains free, at least momentarily, to allow for movement of shuttles 72a-72c into and out of track 70, as described in further detail below. In one embodiment, the fastener is a sheath anchor 80 used to secure the proximal end of sheath body 28 to patient 20.

[0071] In the embodiment shown in FIGS. 7A-7D, the track 70 has at least one row of teeth 84 (only one row is shown) along its length that engage corresponding drive mechanisms (e.g., a rack and pinion arrangement, described in further detail below) of the shuttles 72a-72c to facilitate axial translation of the shuttles 72a-72c along the track 70. Although the teeth 84 are shown disposed at the ends of the track 70, the teeth 84 may be disposed anywhere on the track 84, for example, on the top surface of the track 70. Alternatively, the track 70 may have other types of elements, such as friction surfaces, helical elements, etc., that facilitate axial movement of the shuttles 72a-72c along the track 70. In the illustrated embodiment, the track 70 takes the form of an open monorail on which the shuttles 72a-72c ride, although in alternative embodiments, the track 70 may have multiple rails (e.g., a pair of rails) on which the shuttles 72a-72c run. In an alternative embodiment, the track 70 could take the form of a rigid rod attached to the table, however this would eliminate the advantage offered by a flexible track, namely the ability to adapt the shape of the track to the patient room environment.

[0072] Because the robotic endovascular system 10 utilizes multiple independent drive systems in the form of shuttles 72, it is important that the position of every shuttle 72 on the track 70 is known at all times so that the control station 16 can track the relative positions of the shuttles 72. To this end, the track 70 includes one or more encoders indicative of the position of the shuttles 72 relative to the track 70, and one or more sensors configured to read the encoders and output electrical signals indicative of the respective positions of the shuttles 72 relative to the track 70. In the illustrated embodiment, the encoders take the form of a series of embedded or printed reference elements 86 (best shown in FIGS. 7C-7D) along their length, and the sensors take the form of reference element readers (not shown) for reading (e.g., optically, magnetically, capacitively, etc.) on each shuttle 72a-72c (i.e., on a sled (described in further detail below)) so that at any time the control station 16 may be informed of the position of each shuttle 72 relative to the track 70. In an alternative embodiment, an encoder-sensor pair may be incorporated into each shuttle 72 to inform the control station 16 of the position of the shuttle 72 relative to the track 70. For example, a reference element (not shown) may be located on a rotating portion of a drive mechanism (described in further detail below) carried by each shuttle 72, while a reference element sensor may be located on an interior surface of a housing or casing (described in further detail below) or other stationary frame structure within each shuttle 72. In other alternative embodiments, the track 70 and shuttle 72 may be embedded with active electronic components (e.g., transmitter / receiver pairs) capable of performing position sensing using signaling (e.g., optical, ultrasonic, inductive, capacitive, radio frequency (RF), etc.) to inform the control station 16 of the position of the shuttle 72 relative to the track 70. In yet other alternative embodiments, a reference element (not shown) may be located at the distal end of the elongated medical instrument 26, which may be visually sensed by a vision-based system, such as a fluoroscopic imaging device (not shown), to directly track the position of the elongated medical instrument 26, rather than directly tracking the position of the shuttle 72 relative to the track 70 as a proxy for the position of the elongated medical instrument 26.

[0073] As described in further detail below, shuttles 72a-72c provide in a single unit relative axial tracking of elongate medical devices 26, relative rotational movement of the elongate medical devices, and internal and external power and communications. Shuttles 72a-72b also provide fluid management functions for guide sheath 26a and working catheter 26b, respectively, in contrast to shuttle 72c, to which guidewire 26c is attached, which does not require fluid management functions.

[0074] The shuttles 72a-72c are configured to be removably mechanically coupled to the track 70. In particular, the shuttles 72a-72c are threaded, one at a time, into the proximal end 76 of the track 70 in which they are driven, and can be removed, one at a time, from the proximal end 76 of the track 70. The shuttles 72a-72c are each configured to be removably attached to the elongate medical instrument 26. In the illustrated embodiment, the guide sheath 26a is attached to the distal-most shuttle 72a, the working catheter 26b is attached to the middle shuttle 72b, and the guidewire 26c is attached to the proximal-most shuttle 72c. Each succeeding shuttle 72a-72b is configured to slidably receive, via load / unload port 88, the distal end of a respective one of the elongated medical instruments 26 attached to the preceding shuttle of the shuttles 72b-72c, such that the guide sheath 26a, working catheter 26b, and guidewire 26c are coaxially disposed (i.e., the distal-most shuttle 72a is configured to slidably receive the distal end of the working catheter 26b such that the working catheter 26b is coaxially disposed within the guide sheath 26a, and the intermediate shuttle 72b is configured to receive the distal end of the guidewire 26c such that the guidewire 26c is coaxially disposed within the working catheter 26b). As described in further detail below, the shuttles 72a, 72b may be interchangeable, with shuttle 72a being the intermediate shuttle and shuttle 72b being the distal-most shuttle.

[0075] Each of the shuttles 72a-72c includes a sled 90 configured to ride on the track 70, an axial drive mechanism 92 (e.g., a geared or friction coupling) carried by the sled 90 and configured to operate to axially translate the respective shuttle 72 (and thus each of the elongated medical instruments 26 attached to the respective shuttle 72) along the track 70 (shown in FIGS. 7A and 7D), an axial actuator 94 carried by the sled 90 and configured to operate the axial drive mechanism 92 (shown in FIG. 7D), and a drive mechanism 96 (shown in FIG. 7C). The shuttle 72 includes a rotational drive mechanism 96 (e.g., a geared or friction coupling) carried by the sled 90 and configured to operate to rotate each of the elongated medical instruments 26 attached to each shuttle 72 about its longitudinal axis, a rotational actuator 98 (shown in FIG. 7D) carried by the sled 90 and configured to operate the rotational drive mechanism 96, and an outer casing 100 attached to the sled 90 and containing the axial drive mechanism 92, the axial actuator 94, the rotational drive mechanism 96, and the rotational actuator 98.

[0076] In the illustrated embodiment, the control station 16 operates the endovascular management and tracking system 14 in a master-slave configuration (i.e., a fully automated modality), and the axial actuator 94 and the rotational actuator 98 can include motors (e.g., stepper motors) that, in response to control signals generated by the control station 16, can actuate the respective drive mechanisms 92, 96 to axially translate the respective shuttles 72 along the track 70 and rotate each of the elongated medical instruments 26 about its longitudinal axis.

[0077] As briefly discussed above, the endovascular management and tracking system 14 may be advantageously designed to be dynamically switched between fully automated and fully manual modalities.

[0078] To this end, each of the shuttles 72a-72c further includes a manual actuator 102, 104 (e.g., a hand operated dial, knob, thumb wheel, slider, or other hand operated mechanism) that may be manually operated to axially index each shuttle 72 such that the axial movement of each shuttle 72 along the track 70 may be finely controlled, and / or rotationally index each one of the elongate medical instruments 26 such that rotation of each elongate medical instrument 26 about its axis may be finely controlled. To axially index each shuttle 72 or rotationally index each elongate medical instrument 26, the manual actuators 102, 104 may operate the same drive mechanisms 92, 96 actuated by motors 94, 98, respectively, or may operate a different drive mechanism (not shown) that is entirely independent of the drive mechanisms 92, 96 actuated by motors 94, 98, respectively.

[0079] Alternatively, none of the shuttles 72a-72c have manual actuators 102, 104, and instead, each shuttle 72 may be directly moved manually along the track 70 and / or each of the elongate medical instruments 26 may be directly rotated by hand about its longitudinal axis. In any embodiment, each of the shuttles 72a-72c includes one or more actuators (not shown) (e.g., one or more buttons, sliders, touch sensors, etc.) that can be manually operated to axially translate each shuttle 72 along the track 70 or rotate each one of the elongate medical instruments about its longitudinal axis 26 via actuation of the respective motors 94, 98 and associated drive mechanisms 92, 96.

[0080] Switching between fully automated and fully manual modalities of the endovascular management and tracking system 14 may be accomplished in any one or more of a variety of ways. As an example, each shuttle 72 includes a first clutch mechanism (not shown) configured to alternately engage (e.g., via gear meshing, frictional coupling, motor actuation, etc.) and disengage (e.g., via gear disengagement, frictional coupling disengagement, motor actuation, etc.) at least a portion of the axial drive mechanism 92 between the axial motor 94 and the track 70, and a second clutch mechanism (not shown) configured to be operated to alternately engage (e.g., gear meshing, frictional coupling, motor actuation, etc.) and disengage (e.g., gear disengagement, frictional coupling, motor actuation, etc.) at least a portion of the rotational drive mechanism 96 with which the axial motor 94 is associated with each of the elongated medical instruments 26 attached to the respective shuttle 72.

[0081] Thus, actuating the clutch mechanism to fully engage the axial drive mechanism 92 with the track 70 and fully engage the rotational drive mechanism 96 with each of the elongated medical instruments 26 results in the endovascular management and tracking system 14 being in a fully automated modality (wherein the motors 94, 98, in response to control signals generated by the control station 16, actuate the respective drive mechanisms 92, 96 to axially translate the respective shuttles 72 along the track 70 and rotate the elongated medical instruments 26 about their longitudinal axes), while operating the clutch mechanism to at least partially disengage the axial drive mechanism 92 from the track 70. , when at least a portion of the rotational drive mechanism 96 is disengaged from each elongate medical instrument 26, the endovascular management and tracking system 14 is in a fully manual modality (wherein the manual actuators 102, 104 can be operated to provide fine control over the axial translation of each shuttle 72 along the track 70 and / or fine rotation of each elongate medical instrument 26 about its longitudinal axis, or where each shuttle 72 can be directly manually translated along the track 70 and / or where each elongate medical instrument 26 can be directly manually rotated about its longitudinal axis).

[0082] The clutch mechanism of each shuttle 72 may be operated via a manual input via the respective shuttle 72, via a manual input via another shuttle 72, and / or via an input from the control station 16, and may optionally include a manual / automatic switch to visually indicate engagement or disengagement.

[0083] When the intravascular management and tracking system 14 is operated in a fully manual modality, the manual actuator 102 can actuate the portion of the axial drive mechanism 92 that remains engaged with the track 70 (i.e., the portion of the axial drive mechanism 92 between the clutch point and the track 70) or a completely independent axial drive mechanism to finely control the axial movement of each shuttle 72 along the track 70, and the manual actuator 104 can actuate the portion of the rotational drive mechanism 96 that remains engaged with each of the elongated medical instruments 26 (i.e., the portion of the rotational drive mechanism 96 between the clutch point and each elongated medical instrument 26) or a completely independent axial drive mechanism to finely control the rotation of each elongated medical instrument 26.

[0084] As another example, the motors 94, 98 and associated drive mechanisms 92, 96 may be designed to spin freely when electronically deactivated (e.g., powered down or otherwise put into a sleep mode) in response to low forces. The free spinning ability of the motors 94, 98 and associated drive mechanisms 92, 96 depends on the type of motor used, the control mode of the motor, and the design of the associated drive mechanisms 92, 96. Thus, by electronically actuating (e.g., powering on or otherwise activating) the motors 94, 98, the endovascular management and tracking system 14 is a fully automated modality (such that the motors 94, 98, in response to control signals generated by the control station 18, actuate their respective drive mechanisms 92, 96 to axially translate their respective shuttles 72 along the track 70 and rotate each of the elongated medical instruments 26 about its longitudinal axis), and by powering down or otherwise putting the motors 94, 98 to a sleep state, the endovascular management and tracking system 14 is a fully manual modality (such that the motors 94, 98, in response to control signals generated by the control station 18, actuate their respective drive mechanisms 92, 96 to axially translate their respective shuttles 72 along the track 70 and rotate each of the elongated medical instruments 26 about their ...). 02, 104 may be manipulated to provide fine control over the axial translation of each shuttle 72 along track 70 and / or fine rotation of each elongated medical instrument 26 about its longitudinal axis, or each shuttle 72 may be directly manually translated along track 70 (e.g., by manually grasping outer casing 100) and / or each elongated medical instrument 26 may be directly manually rotated about its longitudinal axis (e.g., by rotating proximal adapter 36 of guide sheath 26a, proximal adapter 46 of working catheter 26b, or collet 56 of guidewire 26c).

[0085] If the endovascular management and tracking system 14 is designed to operate in a fully manual modality in a dedicated manner (i.e., without a motor), each shuttle 72 may not include an actuator (e.g., the shuttle 72 may be manually translated along the track 70 directly by hand and / or each elongate medical instrument 26 may be rotated about its longitudinal axis directly by hand), or, instead of a motor, the axial actuator 94 and / or the rotational actuator 98 may include a manual actuator (e.g., a manually operated dial, knob, thumb wheel or other manually actuated mechanism) to axially index the shuttle 72 so that the axial movement of the shuttle 72 along the track 70 may be finely controlled and / or to rotationally index each elongate medical instrument 26 so that the rotation of each elongate medical instrument 26 about its axis may be finely controlled.

[0086] In any embodiment, each of the shuttles 72a-c may have a locking mechanism 106 (shown in FIGS. 7A and 7D ) for stopping or locking the respective shuttle 72 in position on the track 70 to prevent uncommanded movement of the respective shuttle 72 on the track 70 when the shuttle 72 is in either a fully automated modality (in which case the motor cannot lock the shuttle 72 in position on the track via the first clutch mechanism) or a fully manual modality. In another optional embodiment, each of the shuttles 72a-c includes a reference element (not shown) embedded or printed about the periphery of the portion of the rotational drive mechanism 96 that directly engages the respective elongated medical instrument 26, which can be read by optical or magnetic means such that the rotational position of the elongated medical instrument 26 is known to the control station 16 at any given time.

[0087] The proximal-most shuttle 72c, to which the guidewire 26c is attached, may be proximate to the intermediate shuttle 72b, and in the illustrated embodiment may be rigidly coupled to the intermediate shuttle 72b, such that the shuttles 72b-72c translate axially along the track 70 as a single unit. For example, the proximal-most shuttle 72c includes a male plug 108 (shown in FIG. 6) disposed at the proximal end of the outer casing 100 for removably mating with the load / unload port 88 of the intermediate shuttle 72b. In an alternative embodiment, rather than using a shuttle to translate the guidewire 26c axially along the track 70, an alternative conventional drive mechanism (e.g., pinch rollers or caterpillar tractor) may be used to translate the guidewire 26c axially along the track 70.

[0088] Each of the shuttles 72a-72b is fluidly coupled to a respective one of the guide sheaths 26a and working catheters 26b and has an on-board fluid management control assembly 110 carried on threads 90 within the outer casing 100 that, among other things, enables connection between a fluid source (e.g., saline and contrast) and the guide sheath 26a and working catheter 26b attached to the respective shuttle 72a-72b in a controlled manner. It should be noted that the shuttle 72c to which the guidewire 26c is attached need not have fluid management capabilities and thus the shuttle 72c does not have a fluid management control assembly.

[0089] In the illustrated embodiment, the on-board fluid management control assembly 110 of each shuttle 72a-72b includes a rotatable hemostasis valve (RHV) 112, a flush line 114 in fluid communication with the RHV 112, and an on-board contrast injection port 116 in fluid communication with the RHV 112 and attached to the outer casing 100. The RHV 112 may be permanently incorporated within each of the shuttles 72a-72b, but preferably each of the shuttles 72a-72b removably receives the RHV 112. In this manner, the RHV 112 may be discarded after use and replaced with a new RHV 112, allowing the shuttles 72a-72b to be reused.

[0090] 8, the RHV 112 comprises a cylindrical tube 118 having a central lumen 120, a conventional male Touhy-Borst connector 122 rotatably mounted to the distal end of the cylindrical tube 118, and a side arm 124 attached to the cylindrical tube 118 and having a side lumen 126 in fluid communication with the central lumen 120 of the cylindrical tube 118. The flush line 114 is attached to the side arm 124 so as to be in fluid communication with the side lumen 120 of the side arm 124, and the on-board contrast injection port 116 is in fluid communication with the central lumen 120 of the cylindrical tube 118.

[0091] The Touhy-Borst connector 122 may be rotated by hand or may be engaged with a rotation mechanism (as part of a rotation drive mechanism 96, described in more detail below) that may be manually actuated or remotely driven via a motor or manual actuator. The proximal adapter 36 of the guide sheath 26a or the proximal adapter 46 of the working catheter 26b (shown in FIG. 3) is configured to be coupled to the Touhy-Borst connector 122 of the respective shuttle 72a or shuttle 72b such that the central lumen 120 of the cylindrical tube 118, and thus the side lumen 120 of the side arm 124, is in fluid communication with the lumen 42 of the proximal adapter 36 or the lumen 62 of the proximal adapter 46, and thus the central lumen 34 of the guide sheath 26a or the central lumen 44 of the working catheter 26b. Because the Touhy-Borst connector 122 is rotatable relative to the cylindrical tube 118, the guide sheath 26a or working catheter 26b can be rotated about their longitudinal axes without rotating the cylindrical tube 118 and side arm 124.

[0092] The central lumen 120 of the cylindrical tube 118 is sized to receive the working catheter 26b through a load / unload port 88 formed at the proximal end of the outer casing 100 (if the RHV 112 is associated with the shuttle 72a to which the guide sheath 26a is attached) or through a guidewire 26c (if the RHV 112 is associated with the shuttle 72b to which the working catheter 26b is attached). The RHV 112 further includes a proximal seal 128a and a distal seal 128b disposed within the central lumen 120 of the cylindrical tube 118 to seal against fluid flow between an outer surface of the working catheter 26b or the guidewire 24 and the central lumen 120 of the cylindrical tube 118. The RHV 112 further includes a compression nut 130 configured to rotate to compress the distal seal 128b against an outer surface of the working catheter 26b or the guidewire 26c.

[0093] All fluid inputs may be integrated into each shuttle 72a-72b or may exist as separate exchange elements that can be loaded into the shuttles 72a-72b. In the illustrated embodiment, the flush line 122 is hard mounted to the outer casing 100 in fluid communication with the side lumen 120 of the side arm 124 and has a female luer lock port (not shown) for connection to a saline bag (not shown). In an alternative embodiment, a female luer lock port (not shown) can be hard mounted to the outer casing 100 in fluid communication with the side lumen 120 of the side arm 124, in which case a flush line with a male luer fitting can be placed in fluid communication with the saline bag to the female luer lock port. The female luer lock port can have a built-in septum that allows saline flow only when the male luer lock fitting to which the flush line is connected is coupled to the female luer lock port.

[0094] In the illustrated embodiment, the fluid injection port 124 takes the form of a female luer lock port hard mounted to the casing 100 in fluid communication with the central lumen 120 of the cylindrical tube 118. A tube having a male luer fitting (not shown) can fluidly couple contrast to the female luer lock port. In an alternative embodiment, a tube is hard mounted to the outer casing 100 in fluid communication with the central lumen 120 of the cylindrical tube 118 and has a female luer lock port (not shown) for connection to a source of contrast. The female luer lock port may have a built-in septum to permit contrast flow only when the male luer lock fitting to which the tube is connected is mated to the female luer lock port. In any embodiment, an automatic injector configured to deliver a bolus of contrast can be connected to the injection port 124 to allow contrast injection to be controlled remotely, in particular from the control station 16.

[0095] A valve system 130 (shown in FIG. 6) can be used to manage the coupling of saline and contrast to the guide sheath 26a or working catheter 26b. Such a valve system 130 can connect any two of the three flow paths (flush line 122, fluid injection port 124, and central lumen 112 of cylindrical tube 118). Valve system 130 can be constructed using a variety of different valve types (stopcocks, ball valves, pinch valves, needle valves, diaphragm valves, solenoid valves, etc.), but is typically manually operated using a physical lever, switch, push button selector, thumb roller, etc. Alternatively, valve system 130 can be automatically operated by control station 16.

[0096] In an alternative embodiment, instead of a separate valve system 130, the flush line 122 includes a one-way valve to prevent backflow. Thus, normal saline flow always occurs through the flush line to the RHV 112 unless fluid is injected through the injection port 124, in which case the one-way valve in the flush line 122 blocks the saline flow and only contrast injection occurs to the RHV 112.

[0097] The RHV 112 and optional valve system 130 may be permanently incorporated into each shuttle 72a-72b or may be designed as separate replacement elements, for example in a single replaceable module, such that the shuttles 72a-72b can be cleaned and reused after each procedure while the necessary sterile elements and fluid connections can be replaced after each procedure. If reuse of the shuttles 72a-72b is desired, the design may be specially configured to facilitate cleaning within the hospital or return to a dedicated reprocessing facility for cleaning, refitting of replaceable elements (fluid handling components, batteries, motors, gears, etc.), retesting of functionality, repackaging, and resterilization.

[0098] It should be appreciated that because the axial drive mechanism 92 and the RHV 112 are disposed within the same outer casing 100, the unusable length of the guide sheath 26a or working catheter 26b (i.e., the length that cannot be inserted into the patient 20) is minimized. For example, the unusable length of the guide sheath 26a may be equal to the length of the sheath anchor 80 to which the arterial access sheath 78 is attached, while the unusable length of the working catheter 26b may be equal to the sum of the length of the sheath anchor 80 to which the arterial access sheath 78 is attached and the length of the outer casing 100 to which the guide sheath 26a is attached and the working catheter 26b is slidably and rotatably disposed via the central lumen 120 of the cylindrical tube 118 of that RHV 112 (approximately the length of the RHV 112 contained within that outer casing 100).

[0099] The rotational drive mechanism 96 associated with each shuttle 72a-72b may directly engage the guide sheath 26a or working catheter 26b, however, in one embodiment, the rotational drive mechanism 96 indirectly engages the guide sheath 26a or working catheter 26b via a Touhy-Borst connector 122 of the RHV 112. In other embodiments, the entirety of the rotational drive mechanism 96, as well as the rotational actuator 98, are incorporated into the RHV 112. The rotational drive mechanism 96 associated with the proximal-most shuttle 72c may directly engage the guidewire 26c via a collet 56 attached to the proximal end 52 of the guidewire body 50.

[0100] Although the rotational drive mechanism 96 associated with each of the shuttles 72a-72c is designed to rotate the guide sheath 26a, working catheter 26b, and guidewire 26c about their longitudinal axes relative to the respective sleds 90, in an alternative embodiment, each of the shuttles 72a-72c may include an on-board rotational drive mechanism that rotates the entire respective shuttle 72, and thus each of the guide sheaths 26a, working catheters 26b, and guidewires 26c attached to each shuttle 72, about their longitudinal axes relative to the track 70. However, in this alternative case, the track 70 must be positioned relative to the hospital environment such that each of the shuttles 72a-72c can freely rotate about the track 70 without colliding with the hospital environment.

[0101] In another alternative embodiment, the rotational drive mechanism and rotational actuator may be external to one or more of the shuttles 72a-72c rather than being incorporated into each of the shuttles 72a-72c, in which case the guide sheath 26a, working catheter 26b, and / or guidewire 26c may be fixed to the shuttles 72a-72c so as not to rotate relative to them, but instead the rotational drive mechanism may rotate the entire shuttle 72 to rotate the guide sheath 26a, working catheter 26b, and / or guidewire 26c.

[0102] The threads 90 and outer casing 100 are preferably shaped to prevent the respective shuttles 72 from catching or becoming entangled in the hospital environment, particularly the drape 22 upon which the track 70 will be placed. As the drape 22 rests on the procedure table 18 and patient 20, the drape 22 is not always flat. As such, the drape 22 folds and bunches, and as the shuttle 72 translates axially along the track 70, if the shuttle 72 is shaped with flat surfaces or sharp edges, it may catch on the drape 22, thereby causing interference motion and / or applying an undesirable amount of force to the track 70. In such an event, the track 70 may be pulled out of the sheath anchor 80, or even worse, the arterial access sheath 78 may be pulled out of the patient 20. As such, the threads 90 and outer casing 100 preferably have smooth edges to allow the drape 22 to deflect rather than catch on the threads 90 or outer casing 100.

[0103] In contrast to the proximal-most shuttle 72c to which the guidewire 26c is attached, which generally does not have an exposed length between the proximal-most shuttle 72c and the middle shuttle 72b that is large enough to prolapse in response to an axial compressive force (indeed, the proximal-most shuttle 72c has no exposed length, as it may be plugged into the middle shuttle 72b via engagement of the plug 108 and the load / unload port 88), the exposed length at any time of the guide sheath 26a between the distal-most shuttle 72a and the sheath anchor 80, or the exposed length at any time of the working catheter 26b between the middle shuttle 72b and the distal-most shuttle 72a, may be long enough to allow the guide sheath 26a or working catheter 26b to prolapse in response to an axial compressive force.

[0104] Thus, each of the shuttles 72a-72b includes an anti-buckling mechanism 132 carried on the threads 90 and configured to prevent prolapse of each of the guide sheath 26a and working catheter 26b in response to axial compression applied to each of the guide sheath 26a and working catheter 26b (e.g., to prevent prolapse of the guide sheath 26a and working catheter 26b when the respective shuttle 72a-72b is axially moved in a distal direction, or to prevent prolapse of the working catheter 26b when the shuttle 72a is axially moved in a proximal direction). The anti-buckling mechanism 132 may be rigidly or removably secured to the threads 90 or outer casing 100 of the respective shuttle 72a-72b. Importantly, in contrast to a fixed length of support to prevent prolapse of the guide sheath or working catheter, the anti-buckling mechanism 132 provides a variable length of support to the guide sheath 26a or working catheter 26b attached to the respective shuttle 72a-72b to which the anti-buckling mechanism 132 is attached, thereby minimizing the unused length of the guide sheath 26a or working catheter 26b and avoiding catheter overlap problems.

[0105] In the illustrated embodiment, the anti-buckling mechanism 132 comprises a storage housing 134 and an axially split sheath 136 configured to be alternately rolled up and out of the storage housing 134 to change its linear dimensions to prevent buckling of the guide sheath 26a or working catheter 26b under compressive loads. The storage housing 134 is configured to house the axially split sheath 136 to prevent entanglement or interference with other elements of the endovascular management and tracking system 14 or the hospital environment.

[0106] 9-10, the axially split sheath 136 includes an elongated tubular body 138 having a proximal end (not shown) and a distal end 142 (shown in FIG. 6), a central lumen 144 extending between the proximal and distal ends 142 of the tubular body 138, and a split portion 146 extending axially between the proximal and distal ends 140 and 142 of the tubular body 138.

[0107] The axial split sheath 136 is transitionable between a tubular state and a flattened state. Thus, at any given time, the distal portion 148a of the axial split sheath 136 is in a tubular state and the proximal portion 148b of the axial split sheath 136 is in a flattened state. The axial split sheath 136 also has a transition portion 148c between the tubular distal portion 148a and the flattened proximal portion 148b that is neither completely tubular nor completely flattened. It should be understood that the length of the axial split sheath 136 is constant, so that as the axial split sheath 136 is unwound from the containment housing 134, the tubular distal portion 148a gets longer while the flattened proximal portion 148b gets shorter, and as the axial split sheath 136 is wound into the containment housing 134, the flattened proximal portion 148b gets longer while the flattened proximal portion 148b gets shorter.

[0108] In one embodiment, the axially split sheath 136 is made of an elastomeric or shape-recoverable material that is preformed to be in a tubular state when unwound from the receiving housing 134, but to be in a flattened state when wound into the receiving housing 134. By way of example, the construction of the axially split sheath 136 can be a simple elastomeric tube, a wire / braid reinforced tube (particularly one with wires that are shape-recovered to a cylindrical shape), or a laser cut tube (particularly using hard materials ranging from stiff polymers, polyether-etherketone (PEEK), PI, thick polytetrafluoroethylene (PTFE), etc., to metals with yield strains greater than 1%, such as spring steel, Nitinol, etc.). In this manner, the flattened proximal portion 148b will only be in a flattened state in the presence of an external force, such as that applied by a flattening mechanism described in more detail below.

[0109] In another embodiment, the axially split sheath 136 may be preformed to have both a tubular state and a flattened state such that the axially split sheath 136 has a bistable structure. The axially split sheath 136 may be constructed of a suitable material, for example, a carbon fiber composite laminated or impregnated with a polymer, and may be preformed to have a bistable structure. The axially split sheath 136 then maintains its tubular shape until an external force is applied to transition the axially split sheath 136 to the flattened state, and similarly, the axially split sheath maintains its flattened state until an external force is applied to transition the axially split sheath 136 from the flattened state to the tubular state. In this manner, the flattened proximal portion 148b of the axially split sheath 136 does not attempt to transition to the tubular state and therefore remains completely flattened. Thus, the axially split sheath 136 can be rolled up more tightly within the storage housing 134 to a more compact shape by simply pushing the axially split sheath 136 toward the storage housing 134. In this manner, the axially split sheath 136 is more consistently deployed from and wound into the storage housing 134 and maintains a flattened configuration when wound, without the need for a powered winding mechanism that would otherwise tension the axially split sheath 136.

[0110] 6 and 11A-11D, the distal end 142 of the tubular body 138 is attached at a certain position, and as the tubular distal portion 148a of the axial split sheath 136 increases the distance between the respective shuttle 72 and the position (i.e., as the respective shuttle 72 is axially translated away from the attachment position or the attachment position is axially translated away from the respective shuttle 72), the distal end 142 of the tubular body 138 becomes longer, and as the distance between the respective shuttle 72 and the position decreases (e.g., as the respective shuttle 72 is axially translated toward the attachment position or the attachment position is axially translated toward the respective shuttle 72), the distal end 142 of the tubular body 138 becomes shorter.

[0111] In the illustrated embodiment, the attachment location of the distal end 142 of the tubular body 138 associated with the distal-most shuttle 72a is a location relative to the patient 20, e.g., a location relative to a sheath anchor 80 used to attach the distal end 74 of the track 70 at or near an access site of the patient 20, and the attachment location of the distal end 142 of the tubular body 138 associated with the intermediate shuttle 72b (the "leader shuttle") is the distal-most shuttle 72a (the "trailing shuttle"). To this end, the anti-buckling feature 132 further includes a male connector 150 (e.g., a clip or plug) at the distal end 142 of the tubular body 138 which removably mates with a load / unload port 82 disposed within the proximal end of the sheath anchor 80, thereby providing a rigid attachment point to the sheath anchor 80 (in the case where the anti-buckling feature 132 provides support for a guide sheath 26a attached to the distal-most shuttle 72a), or alternatively, with a load / unload port 88 formed in the proximal end of the outer casing 100 of the distal-most shuttle 72a, thereby providing a rigid attachment point to the distal-most shuttle 72a (in the case where the anti-buckling feature 132 provides support for a working catheter 26b attached to the intermediate shuttle 72b). Not only do the anti-buckling features 132 provide an attachment means for the distal end 142 of the tubular body 138, but the anti-buckling feature 132 on the distal-most shuttle 72a positions the guide sheath 26a to smoothly enter the load / unload port 82 of the sheath anchor 80, and the anti-buckling feature 132 on the intermediate shuttle 72b positions the working catheter 26b to smoothly enter the load / unload port 88 of the distal-most shuttle 72a.

[0112] Thus, as the distal-most shuttle 72a is translated axially in a proximal direction 150a toward the middle shuttle 72b, the distal portion 148 of the axial split sheath 136 associated with the distal-most shuttle 72a is lengthened and the distal portion 148 of the axial split sheath 136 associated with the middle shuttle 72b is shortened (see FIG. 11A). In contrast, as the distal-most shuttle 72a is translated axially in a distal direction 150b away from the middle shuttle 72b, the distal portion 148 of the axial split sheath 136 associated with the distal-most shuttle 72a is shortened and the distal portion 148 of the axial split sheath 136 associated with the middle shuttle 72b is lengthened (see FIG. 11B). As the middle shuttle 72b is translated axially in a distal direction 150c toward the distal-most shuttle 72a, the distal portion 148 of the axial split sheath 136 associated with the middle shuttle 72b is shortened (see FIG. 11C). In contrast, as the middle shuttle 72b translates axially in the proximal direction 150d, away from the distal-most shuttle 72a, the distal portion 148 of the axially split sheath 136 associated with the middle shuttle 72b lengthens (see FIG. 11D).

[0113] It should be appreciated that the split 146 in the tubular body 138 serves to facilitate the laying down of the axially split sheath 136 by laterally expanding the tubular body 138 into a ribbon-like opening. The split 146 in the tubular body 138 also serves to expose the central lumen 144, which allows the guide sheath 26a or working catheter 26b to be laterally loaded into the central lumen 144 exposed at the interface between the tubular distal portion 148a and the transition portion 148c of the axially split sheath 136. The central lumen 144 is sized to slidably receive the guide sheath 26a or working catheter 26b, such that the axially split sheath 136 provides support to the guide sheath 26a or working catheter 26b. Although the axially split sheath 136 may be laterally flexible, it is preferable that the axially split sheath 136 have sufficient columnar strength such that the tubular distal portion 148a prevents prolapse of the guide sheath 26a or working catheter 26b when an axial compressive force caused by axial displacement of the shuttles 72a-72b is applied to the guide sheath 26a or working catheter 26b.

[0114] As each of the shuttles 72a-72b axially translates each of the guide sheath 26a and working catheter 26b distally, the tubular distal portion 148a of the axial split sheath 136 lengthens to encase the respective guide sheath 26a or working catheter 26b at the transition portion 148c. In contrast, as each of the shuttles 72a-72b axially translates each of the guide sheath 26a and working catheter 26b distally, the tubular distal portion 148a of the axial split sheath 136 lengthens to peel away from the respective guide sheath 26a or working catheter 26b at the transition portion 148c.

[0115] In various embodiments, the anti-buckling mechanism 132 may have any suitable configuration of a flattening mechanism (e.g., rollers, pins, rectangular orifices, etc.) for transitioning the axially split sheath 136 from a tubular state to a flattened state as it is wound into the containment housing, a tube forming mechanism (e.g., arcuate abutment surface) for transitioning the axially split sheath 136 from the flattened state to a tubular state as it is deployed from the containment housing, and a take-up spool for winding the axially split sheath 136.

[0116] 12A, for example, one embodiment of the anti-buckling mechanism 132a includes a take-up reel 152 configured to alternately wind and unwind the flattened proximal portion 148b of the axially split sheath 136. In this embodiment, the take-up reel 152 is disposed outside the casing 100 and has an axis of rotation (out of the drawing) that is parallel to the plane in which the track 70 extends. The anti-buckling mechanism 132a further includes a flattening mechanism in the form of a pair of pinch rollers 154a, 154b between which the axially split sheath 136 is closely positioned. In this manner, the axially split sheath 136 transitions from a flattened state to a tubular state at the point of contact between the pinch rollers 154a, 154b as the axially split sheath 136 axially translates in the proximal direction 150' relative to the shuttle 72 (i.e., as the axially split sheath 136 is wound up), and transitions from a flattened state to a tubular state at the point of contact between the pinch rollers 154a, 154b as the axially split sheath 136 axially translates in the distal direction 150" relative to the shuttle 72 (i.e., as the axially split sheath 136 is unwound). Thus, the flattened proximal portion 148b of the axially split sheath 136 extends proximally from the pinch rollers 154a, 154b, which then becomes the transition portion 148c of the axially split sheath 136, which then becomes the tubular distal portion 148a extending distally from the pinch rollers 154a, 154b.

[0117] In this embodiment, the axial split sheath 136 may be pre-shaped to be tubular in the absence of external forces such that it naturally transitions from a flattened state to a tubular state upon axial translation of the axial split sheath 136 in the distal direction 150" relative to the shuttle 72. The elongated medical instruments 26 (e.g., guide sheath 26a and working catheter 26b) may be loaded into the exposed central lumen 144 at the interface between the tubular distal portion 148a and transition portion 148c of the axial split sheath 136.

[0118] 12B, another embodiment of anti-buckling mechanism 132b is similar to anti-buckling mechanism 132a of FIG. 12A, except that take-up reel 152 is disposed inside casing 100. Anti-buckling mechanism 132b further includes a tube forming mechanism 156 distal to pinch rollers 154a, 154b and in which axially split sheath 136 is disposed. In the same manner as described above with respect to FIG. 12A, axially split sheath 136 transitions from a tubular state to a flattened state at the point of contact between pinch rollers 154a, 154b as axially split sheath 136 axially translates in a proximal direction 150′ relative to shuttle 72 (i.e., as axially split sheath 136 winds up). However, as the axially split sheath 136 axially translates in the distal direction 150" relative to the shuttle 72 (i.e., as the axially split sheath 136 unwinds), rather than transitioning from the flattened state to the tubular state at the point of contact between the pinch rollers 154a, 154b, the transition occurs at the tube forming mechanism 156. Thus, the flattened proximal portion 148b of the axially split sheath 136 extends proximally from the pinch rollers 154a, 154b, while the transition portion 148c of the axially split sheath 136 extends between the pinch rollers 154a, 154b and the tube forming mechanism 156, and the tubular distal portion 148a of the axially split sheath 136 extends distally from the tube forming mechanism 156.

[0119] In this embodiment, the axially split sheath 136 may be bistable such that it transitions from the tubular state to the flattened state only in response to an external force applied by the pinch rollers 154a, 154b when the axially split sheath 136 is axially moved in the proximal direction 150' relative to the shuttle 72, and transitions from the flattened state to the tubular state only in response to an external force applied by the tube forming mechanism 156 when the axially split sheath 136 is axially moved in the distal direction 150" relative to the shuttle 72. The anti-buckling mechanism 132b further includes an idler roller 158 against which the flattened proximal portion 148b of the axially split sheath 136 abuts, thereby directing it towards a take-up reel 152 disposed inside the casing 100.

[0120] 12C, yet another embodiment of an anti-buckling mechanism 132c is similar to the anti-buckling mechanism 132b of FIG. 12B, except that the distance between the pinch rollers 154a, 154b and the take-up reel 152 is greater.

[0121] Referring to FIG. 12D, yet another embodiment of anti-buckling mechanism 132d is similar to anti-buckling mechanism 132a of FIG. 12A, except that take-up reel 152 is positioned outside casing 100 and has an axis of rotation (out of the drawing) perpendicular to the plane in which track 70 extends.

[0122] In the illustrated embodiment, the axially split sheath 136 is configured to be passively wound within the receiving housing 134 associated with each of the shuttles 72a-72b. That is, the anti-buckling mechanism 132 does not have a mechanism within the receiving housing 134 that actively pulls (i.e., winds) the axially split sheath 136 into the receiving housing 134. Instead, each axially split sheath 136 is wound within the receiving housing 134 by an external compressive force applied to the axially split sheath 136 associated with the distal-most shuttle 72a when the distal-most shuttle 72a is axially translated in the distal direction 150″, and by a compressive force applied to the axially split sheath 136 associated with the middle shuttle 72b when the middle and distal shuttles 72b are axially displaced relative to one another.

[0123] In an alternative embodiment, the storage housing 134 may include a winding biasing mechanism (not shown) for applying a passive storage force that causes the flattened proximal portion 148b of the axial split sheath 136 to contact and maintain a tight configuration during repeated winding and unwinding of the axial split sheath 136 in and out of the storage housing 134 in response to back and forth motion of the distal and intermediate shuttles 72a, 72b (in the illustrated embodiment, when the distal-most shuttle 72a is axially translating in a distal direction or when the intermediate and distal shuttles 72b, 72a are axially displaced relative to one another). Without such a passive storage force, the size (i.e., diameter) of the rolled flattened proximal portion 148b of the axial split sheath 136 may become larger than the allotted space within the storage housing 136, thereby preventing the axial split sheath 136 from being wound or unwound in and out of the storage housing 134. Such passive storage forces are preferably biased to prevent unrestricted movement of the guide sheath 26a or working catheter 26b into the patient 20, preferably without biasing to prevent coiling of the axial split sheath 136 (i.e., shortening of the tubular distal portion 148a) within the storage housing 134, but rather without preventing deflection or opening of the axial split sheath 136.

[0124] As described in further detail below, some embodiments of the anti-buckling mechanism may apply such a passive retraction force to the axially split sheath 136. In other, more complex embodiments, the retraction biasing mechanism may include a tension spring (not shown) or a motor (not shown) that applies a constant tension to the flattened proximal portion 148b of the axially split sheath 136. If a motor is used to apply a constant tension to each axially split sheath 136 and the axial actuator 94 used to operate the axial drive mechanism 92 that axially translates the distal shuttle 72a or the intermediate shuttle 72b along the track 70 is a motor, then both motors can be indexed to match each other such that the speed at which the axially split sheath 32 retracts or unretracts matches the speed of the respective shuttle 72 as it is axially translated along the track 70.

[0125] In any embodiment, the buckling prevention mechanism 132 associated with either or both of the shuttles 72a-72b may further function as an actuator and an axial drive mechanism for axially translating the shuttles 72a-72b. In this case, the axial split sheath 136 of the buckling prevention mechanism 132 may take the place of the axial drive mechanism 92 described above, while a motor (not shown) within the storage housing 134 of the buckling prevention mechanism 132 may take the place of the electric actuator 94 described above. In this manner, the axial split sheath 136 is configured to be actuated to wind the axial split sheath 136 into and unwind the axial split sheath 136 from the storage housing 134 while axially translating each of the shuttles 72a-72b, while the motor within the storage housing 134 is configured to actuate the axial split sheath 136 in response to a control signal generated by the master input device 194. When used as an axial drive mechanism, the axially split sheath 136 preferably has the requisite columnar strength so that the axially split sheath 136 does not escape under compression when unwound from the receiving housing 134 for each shuttle 72a-72b.

[0126] In the case of the distal-most shuttle 72a, active winding of the axial split sheath 136 into the receiving housing 134 creates axial tension within the axial split sheath 136 between the distal-most shuttle 72a and a fixed location relative to the patient 20 (e.g., a sheath anchor 80 used to secure the distal end 74 of the track 70 at or near an access site of the patient 20), which in turn causes the distal-most shuttle 72a to translate axially in the distal direction. In contrast, active unwinding of the axial split sheath 136 from the receiving housing 134 creates axial compression within the axial split sheath 136 between the distal-most shuttle 72a and a fixed location relative to the patient 20 (e.g., a sheath anchor 80 used to secure the distal end 74 of the track 70 at or near an access site of the patient 20), which in turn causes the distal-most shuttle 72a to translate axially in the proximal direction 150′.

[0127] In the case of the middle shuttle 72b, active winding of the axial split sheath 136 into the receiving housing 134 creates tension within the axial split sheath 136 between the middle shuttle 72b and the distal-most shuttle 72a, thereby axially translating the middle shuttle 72b in the distal direction. In contrast, active unwinding of the axial split sheath 136 from the receiving housing 134 creates axial compression within the axial split sheath 136 between the middle shuttle 72b and the distal-most shuttle 72a, thereby axially translating the middle shuttle 72b in the proximal direction 150'.

[0128] While the use of the anti-buckling mechanism 132 shown in Figures 12A-12D is suitable for preventing buckling of the guide sheath 26a and working catheter 26b in the intravascular management and tracking system 14 shown in Figures 1-2, it should be understood that such an anti-buckling mechanism 132 may also be used in other types of catheter drive systems, including conventional drive systems that do not utilize a shuttle that translates axially on a track.

[0129] Additionally, while the use of an axially split sheath that is alternately wound and unwound in and out of a storage housing provides an elegant and simple solution for supporting and preventing prolapse of the guide sheath 26a and working catheter 26b as they undergo axial compression in response to axial displacement of the shuttles 72a-72b along the track 70, alternative embodiments of the anti-buckling mechanism may use other means for providing variable lengths of support to the guide sheath 26a or working catheter 26b when mounted in the endovascular management and tracking system 14 illustrated in Figures 1-2. In much the same manner as the anti-buckling mechanism 132 described above, the distal end of each of these scissor mechanisms is mounted to a location (e.g., the sheath anchor 80 when associated with the distal-most shuttle 72a, or the distal-most shuttle 72a when associated with the intermediate shuttle 72b) such that these anti-buckling mechanisms lengthen as the respective shuttle 72 translates axially away from that location and shorten as the respective shuttle 72 translates axially toward that location.

[0130] An alternative embodiment of the anti-buckling feature 132-1 comprises a scissor mechanism 160 that can extend (FIG. 13A) or retract (FIG. 13B). The scissor mechanism 160 includes two series of hinged links 162a, 162b that are interconnected at midpoints 164 of the hinged links 162a, 162b and hinge away from each other to lengthen the scissor mechanism 160 or hinge towards each other to shorten the scissor mechanism 160. The anti-buckling feature 132-1 may comprise a series of loops 166 attached along the length of the scissor mechanism 160 through which the guide catheter 24 or working catheter 26b is slidably disposed.

[0131] Another alternative embodiment of anti-buckling feature 132-2 includes a linear slide mechanism 168 that can be extended (FIG. 14A) or shortened (FIG. 14B). Linear slide mechanism 168 includes a plurality of rigid linear slides 170a-170c that slide relative to one another to lengthen or shorten linear slide mechanism 168. Anti-buckling feature 170-2 may include a series of loops 172 attached along the length of linear slide mechanism 168 along which guide catheter 24 or working catheter 26b is slidably disposed.

[0132] Yet another alternative embodiment of anti-buckling mechanism 132-3 includes a telescoping mechanism 174 that is extendable (FIG. 15A) and retractable (FIG. 15B). Telescoping mechanism 174 includes a plurality of hollow cylinders 176a-176c that slidably fit together to lengthen or retract telescoping mechanism 174. Telescoping mechanism 174 includes a central lumen 178 (shown in phantom) within which guide catheter 24 or working catheter 26b is slidably disposed.

[0133] Yet another alternative embodiment of anti-buckling mechanism 132-4 includes an accordion mechanism 180 that is capable of lengthening (FIG. 16A) and shortening (FIG. 16B). Accordion mechanism 180 includes multiple sections 182 that fold away from one another to lengthen accordion mechanism 180 or fold toward one another to shorten accordion mechanism 180. Accordion mechanism 180 includes a central lumen 184 within which guide catheter 24 or working catheter 26b is slidably disposed.

[0134] Yet another alternative embodiment of the anti-buckling mechanism 132-5 includes a linear spring mechanism 186 that is extendable (FIG. 17A) and retractable (FIG. 17B). The linear spring mechanism 186 includes a plurality of coils 188 that are displaceable away from one another to extend the linear spring mechanism 186 or toward one another to retract the linear spring mechanism 186. The linear spring mechanism 186 includes a central lumen 190 within which the guide catheter 24 or working catheter 26b is slidably disposed.

[0135] In an alternative embodiment of the coaxial intravascular assembly 12, the working catheter 24 and / or the guidewire 26 may be reinforced to make the coaxial intravascular assembly 12 less susceptible to buckling. In this case, one or both of the shuttles 72a-72b may not use the anti-buckling feature 132.

[0136] In one embodiment, where the actuators 94, 98 are motorized, each of the shuttles 72a-72c may include a sensor that measures the force or torque applied to the drive mechanisms 92, 96 by the actuators 94, 98, thereby enabling sensing of resistance to movement that may be transmitted back to the haptic interface to communicate haptic feedback to the operator 24 via the control station 16 when input commands are provided via the control station 16, as described in further detail below.

[0137] Communications between and within the endovascular management and tracking system 14 and the control station 16 can be through wired connections, wireless connections, or combinations thereof. All standard communication architectures (e.g., Ethernet, USB, Wi-Fi, Bluetooth, FireWire, etc.) and all data transfer protocols are contemplated forming either a centralized control where the control station 16 manages all communications (point-to-point) or a micro-local network where the endovascular management and tracking system 14 and the control station 16 communicate with each other in a coordinated manner. Data streams between the endovascular management and tracking system 14 and the control station 16 can include information such as, for example, motor / actuator commands, shuttle-based user input commands, flow switch commands, axial track position sense outputs, force / torque sensor outputs, fluid flow rate outputs, pressure sensor outputs, etc.

[0138] As described in further detail below, the control station 16 may be connected to the endovascular management and tracking system 14 via a cable, thereby providing one or more communication links over which signals can be transferred between the control station 16 and the endovascular management and tracking system 14. Alternatively, the control station 16 may be wirelessly connected to the endovascular management and tracking system 14. For example, the control station 16 may be located at a geographically remote location, with communication occurring at least in part over a wide area network, such as the Internet. Additionally, the control station 16 may be connected to the endovascular management and tracking system 14 via a local area network, a non-geographically remote or wireless network.

[0139] 6, in one embodiment, a power and communication cable 192a connects the control station 16 to one of the shuttles 72a-72c, and power and communication cables 192b-192c couple that shuttle to the remaining shuttles in a daisy chain fashion. For example, the power and communication cable 192a can couple the control station 16 to the distal-most shuttle 72a, thereby maintaining power and communication between the control station 16 and the endovascular management and tracking system 14 as a leading shuttle (e.g., the middle shuttle 72b or the proximal-most shuttle 72c) is loaded / unloaded onto the track 70. In other embodiments, separate power and communication wires may individually couple the control station 16 to the shuttles 72a-72c. In an alternative embodiment, rather than using the power and communication cable 192c, power and communication can be provided from the medical shuttle 72b to the proximal shuttle 72c via an electrical connection between the male plug 108 of the proximal-most shuttle 72c and the load / unload port 88 of the middle shuttle 72b.

[0140] In another embodiment, the track 70 is constructed of at least a conductive material and is coupled to a power source such that the track 70 may be energized. In this manner, power may be transferred from the energized track 70 to the shuttles 72a-72c (e.g., via direct sliding contacts or inductive coupling). In yet another embodiment, the shuttles 72a-72c may each be powered by a reusable or disposable battery. In these cases, data may be transferred to or from each shuttle 72a-72c via an individual wireless communication link between each shuttle 72a-72c and the control station 16 (e.g., radio frequency (RF), microwave, infrared (IR), inductive coupling via the track 70, or other wireless transmission link) and / or via a wireless communication link between the shuttles 72a-72c.

[0141] 1 and 2, the control station 16 includes a master input device 194 operatively coupled to the endovascular management and tracking system 14. The operator 24 may interact with the master input device 194 to operate the endovascular management and tracking system 14 in a master / slave arrangement. As such, the master input device 194 is configured to enable the operator 24 to remotely control the endovascular management and tracking system 14 to perform a catheter-based medical procedure on the patient 20 in real time. For example, the master input device 194 may be configured to cause the endovascular management and tracking system 14 to perform various tasks using the coaxial endovascular assembly 12 (e.g., advancing, retracting, rotating, optionally steering the guide sheath 26a, working catheter 26b, and guidewire 26c relative to one another, etc.).

[0142] The control station 16 further includes a control panel 196 (e.g., a pad or on-screen touch control) configured to display status and / or non-physical or non-motion inputs, such as, for example, text, numeric, on / off information, etc. For example, the control panel 196 may be configured to allow the physician to change general settings, set up libraries for each of the shuttles 72, including associating each of the shuttles 72 with a particular one of the elongated medical instruments 26, and couple any of the shuttles 72 to one another to provide synchronized motion between the elongated medical instruments 26. Optionally, the control panel 196 may enable the operator 24 to perform non-real-time functions, such as locking individual shuttles (described in more detail below), synchronizing the shuttles 72, changing synchronization parameters such as direction and rate of motion, and performing interventional / diagnostic functions using the working catheter 26b (e.g., stent delivery, balloon inflation, ablation / mapping of endocardial tissue, ultrasound imaging, atherectomy of blood vessels, delivery of vascular occlusion devices to aneurysms, delivery of contrast / medication, or performing other medical functions for which the working catheter 26b is designed).

[0143] The control panel 196, or a separate graphic display (not shown), may optionally display various aspects of the robotic endovascular system 10. For example, an image of the distal end of the coaxial endovascular assembly 12 may be displayed in real time on the control panel 196 to provide the operator 24 with the current orientation of the elongated medical instrument 26 being positioned within the vasculature of the patient 20. The graphical display 78 may also be configured to display patient-specific information to the operator 24, such as imaging data (e.g., x-ray images, MRI images, CT images, ultrasound images, etc.), hemodynamic data (e.g., blood pressure, heart rate, etc.), and patient record information (e.g., medical history, age, weight, etc.). For example, the control station 16 may interface with an angiography system (not shown) or a display component thereof such that the control station 16 (e.g., control panel 196) can display information and images from the angiography system and vice versa. Additionally, the control station 16 (e.g., control panel 196) may be configured to receive inputs to send commands to the angiography system to move the procedure table 18 or change the position of the x-ray camera / source. The control station 16 (e.g., control panel 196) may also be configured to control or trigger other auxiliary devices such as power injectors and infusion pumps.

[0144] In the illustrated embodiment, the control station 16 is secured to the procedure table 18 via a clamping mechanism 198. The clamping mechanism 198, or a separate clamping mechanism (not shown), can be used to secure the proximal end 76 of the track 70 (shown in FIG. 6). The single point of attachment allows the control station 16 to be clamped to a table or similar surface as needed without taking up valuable space in an operating room environment. In another embodiment, the control station 16 can be set up remotely from the endovascular management and tracking system 14 outside of the radiation field, with communications, processing, and an interventionalist interfacing with the endovascular management and tracking system 14.

[0145] The master input device 194 may include multiple controllers for respectively controlling the movement of each elongate medical instrument 26 via the shuttle 72. All of the movements of each elongate medical instrument 26 may be independently controlled by the multiple controllers of the master input device 194, or alternatively, at least two movements of each elongate medical instrument 26 may be linked together to provide linked movements (e.g., 1:1 linked movements) such that control of one of the elongate medical instruments 26 by one of the multiple controllers of the master input device 194 controls another one of the elongate medical instruments 26 in accordance with the linked movement (either axial translation or rotational movement).

[0146] 18, the master input device 194 includes a linear array of individual control elements 200a-200c and a rail 202 along which the control elements 200a-200c are axially and rotationally slidable (i.e., axially translating along the longitudinal axis 204 of the rail 202 and rotationally translating about the longitudinal axis 204 of the rail 202). The use of the linear array of individual control elements 200a-200c to independently manipulate the elongated medical instruments 26a-26c provides a familiar and intuitive intravascular procedure for the physician, using motions similar to those used in the context of manual catheter inspection instrument manipulation. That is, the operator 24 can grasp one of the control elements 200a-200c and move the grasped control element (either proximally or distally) along the longitudinal axis 204 of the rail 202 to axially translate (either proximally or distally) the elongated medical instrument 26 controlled by the grasped control element 200, or can rotate the grasped control element (either clockwise or counterclockwise) about the longitudinal axis 204 of the rail 202 to rotationally move (either clockwise or counterclockwise) the elongated medical instrument 26 controlled by the grasped control element 200.

[0147] The rail 202 may be rigid to provide the control elements 200a-200c with only two degrees of freedom (DOF) (i.e., linear translation along the longitudinal axis 204 of the rail 202 (z-direction) and rotational movement (roll) about the longitudinal axis 204 of the rail 202) or may be flexible to provide the control elements 200a-200c with an additional four degrees of freedom (i.e., linear translation along the x- and y-directions as well as pitch and yaw relative to the longitudinal axis 204 of the rail 202). In the illustrated embodiment, the rail 200 is straight such that an array of control elements 200a-200c disposed on the rail is straight, although in alternative embodiments, the rail 200 may be slightly curved such that an array of control elements 200a-200c disposed on the rail is slightly curved. Although the control elements 200a-200c are illustrated as cylindrical to emulate the proximal ends of the elongated medical instruments 26a-26c, it should be understood that the control elements 200a-200c may have any suitable cross-section other than circular, such as oval, elliptical, polygonal (e.g., triangular, square, hexagonal, octagonal, etc.).

[0148] Each control element 200a-200c may be operatively associated with a respective shuttle 72a-72c such that each control element controls the movement (axial and rotational) of a guide sheath 26a, working catheter 26b, or guidewire 26c attached to the respective shuttle 72a-72c. In one embodiment, the control elements 200a-200c are axially and rotationally spring biased such that they return to nominal axial translation and rotational translation positions upon release by the operator 24. These nominal axial translation and rotational translation positions are preferably centered within their axial and rotational translation ranges such that the control elements 200a-200c have positive and negative ranges of movement from the nominal positions (i.e., a positive axial translation range, a reverse axial translation range, a clockwise rotational movement range, and a counterclockwise rotational movement range).

[0149] Of note, by clamping the control station 16 at only one point via the clamping mechanism 196, the rail 202 has an open end, thereby facilitating rapid replacement of the control elements 200a-200c. Each of the control elements 200a-200c may be removably attached to the rail 202, and the control elements 200 may be replaceable in that they may be added to or removed from the master input device 194 as needed. Additionally, while the rail 202 may be reusable, the control elements 200a-200c are preferably disposable. Thus, a used control element 200a-200c may be simply removed from the rail 202, discarded, and replaced with a new, sterile control element 200a-200c.

[0150] 18 shows three control elements 200a-c corresponding to three shuttles 72a-c, respectively, it should be understood that the master input device 194 may include any suitable number of control elements 200 depending on the number of shuttles 72 ultimately used. For example, the master input device 194 may have fewer than three control elements 200, e.g., if fewer than three shuttles 72 are used, or may have more than three control elements 200, e.g., if more than three shuttles 72 are used. Less advantageously, the master input device 194 may include a joystick, a keypad or keyboard, a slider, a roller ball, a touch sensor, a touch screen, a mouse, etc., instead of an array of control elements 200.

[0151] In the illustrated embodiment, the control elements 200a-200c may have gradually increasing or decreasing diameters to provide a visual or tactile indication to the physician as to which control element 200a-200c is associated with each of the elongate medical instruments 26a-26c (e.g., the distal-most control element 200a may be operatively associated with the guide sheath 26a and have a relatively large diameter, the intermediate control element 200b may be operatively associated with the working catheter 26b and have a relatively medium diameter, and the proximal-most element 200c may be operatively associated with the guidewire 26c and have a relatively small diameter).

[0152] In any embodiment, the control elements 200a-200c may slide telescopically relative to one another. In another optional embodiment, the control elements 200a-200c may be illuminated in different colors (such as by red, green, and blue (RGB) light emitting diodes (LEDs)) to indicate which control cylinder 200 is active and functionally associated with a respective one of the elongated medical instruments 26a-26c. Inactive control elements 200 may be illuminated in white, a transparent matte color, or a similar less noticeable color. When the operations of two or more elongated medical instruments 26a-26c are linked together, the control elements 200 associated with those linked instruments may have a visual indication, such as a flashing light.

[0153] The control station 16 may optionally include a sterile sleeve 206 configured to cover the master input device 194, thereby providing a sterile barrier between the operator 24 and non-sterile components of the control station 16. To accommodate the sterile sleeve 206, the rail 202 is cantilevered so that the sterile sleeve 206 can be easily slid over the array of control elements 200 from the free end of the rail 202 to the fixed end of the rail 202. The sterile sleeve 206, or a separate sterile sleeve (not shown), may also cover the control panel 196. It is desirable for the sterile sleeve 206 not to restrict the movement of each control element 200. The sterile sleeve 206 may be configured to allow for variation in diameter of the control elements 200. The portions of the sterile sleeve 206 on each control element 200a-200c may be smooth and in close contact with or adjacent to each control cylinder 208, or the sterile sleeve 206 may be loose such that it may have close-packed portions between each pair of adjacent control elements 200.

[0154] 19, instead of a single sterile sleeve covering the entire master input device 194, the control station 16 includes a set of single-use, overlapping sterile control element covers 208a-208c that are configured to be slid into place over the control elements 200a-200c, respectively, thereby providing a sterile surface for the operator 24 to touch. When placed over the respective control elements 200a-200c, the sterile control element covers 208a-208c can form a slidable fluid seal 210 between adjacent control elements 200a-200c to prevent transfer of contaminated fluid between adjacent control elements 200a-200c. The slidable fluid seal 210 can be formed by a slip fit between the control elements 200a-200c or by a sealing member, such as, for example, an O-ring. As shown in FIG. 20, the sterilization control element covers 208a-208c may be packaged as a set of folded, stacked "cups" that can be slid over the control elements 200a-200c.

[0155] Returning to FIG. 18, the control station 16 further comprises a processor 212, which may comprise, for example, a personal computer or other type of computer workstation, for issuing commands to precisely coordinate and control the operation of various motors (described in further detail below) within the endovascular management and tracking system 14. As described in further detail below, the processor 212 may issue instructions to the endovascular management and tracking system 14 according to a mapping algorithm that maps sensed axial translational and rotational movements of the control elements 200a-200c to desired axial translational and rotational movements of the elongated medical instruments 26a-26c. The control station 16 may optionally include various indicators in the form of lights, colored / uncolored segments of a mechanical interface, or audio cues to communicate power, manual / automatic mode, fluid flow or fluid switch status, movement, or errors (e.g., excessive force or torque, controller error, communication error, low battery, etc.).

[0156] The control station 16 further includes one or more devices for providing feedback (e.g., visual, audible, tactile, etc.) to the operator 24. For example, the control station 16 may have a haptic interface 214 that interfaces with the operator 24 and the coaxial intravascular assembly 14 through touch, also known as kinematic stimulation or haptic feedback. The haptic interface 214 communicates haptic feedback to the operator 24, for example, via the master input device 194, when an input command is provided via the master input device 194, such that the operator 24 feels resistance representing the direction and magnitude of force applied to the elongated medical instrument 26 as it moves within the vasculature of the patient 20. Under the control of the processor 212, the haptic interface 214 uses actuators (not shown) to generate and communicate haptic feedback to the operator 24. For example, a motor capable of converting motor torque into resistance (reaction force or vibration) to the movement of the controller may enable the operator 24 to feel when it becomes difficult to move the elongated medical instrument 26. Other examples of transducing tactile feedback to the operator 24 include using weight, pneumatic, magnetic, electrical artificial muscles (electroactive polymers), piezoelectric, ultrasonic, pressure actuators, and the like.

[0157] The actual force exerted on the elongated medical instrument 26 is sensed via any configuration of tactile feedback sensors 216 associated with the catheter tracking and management system 14 and provided as tactile feedback to the processor 212 which accordingly controls the tactile interface 214 to provide tactile feedback to the operator 14.

[0158] For example, a change in current can be detected in the motor of each shuttle 72a-72c to which the elongate medical instruments 26a-26c are mechanically coupled. That is, as a force is applied to the distal end of the elongate medical instruments 26a-26c, the current in the motor driving the elongate medical instruments 26a-26c changes accordingly. As another example, active force sensors (e.g., electrical, piezoelectric, magnetic, resistive, capacitive, pressure, hydraulic, etc.) may be incorporated at the distal tips and / or along the lengths of the elongate medical instruments 26a-26b. As yet another example, forces acting on the distal ends of the elongated medical instruments 26a-26b and mechanically transmitted to the respective anti-buckling mechanisms 132 (shown in FIG. 6 ) may be sensed within the axially split sheath 136 via a deflection detector that measures the deflection of the axially split sheath 136 in response to compressive forces exerted on the distal ends of the elongated medical instruments 26a-26b, or a force or pressure detector that directly measures the force or pressure within the axially split sheath 136. In an alternative embodiment, a medical imaging device (e.g., a fluoroscopic imaging device) may provide visual feedback of the forces exerted on the elongated medical instruments 26a-26b to the processor 212, which in turn may control the haptic interface 214 accordingly to provide haptic feedback to the operator 14. For example, the medical imaging device may detect contact of the distal tips of the elongated medical instruments 26a-26c with a vessel wall or a lesion, or may detect bending of the elongated medical instruments 26a-26c. The processor 212 can use this visual feedback to estimate the forces exerted on the elongate medical instruments 26a-26c.

[0159] As described in further detail below, rather than being integrated into the master input device 194, the haptic interface 214 may alternatively have a wearable form factor such as a finger ring, glove, fingertip pads, wristband, or may generate a non-contact force field using, for example, ultrasonic pads, air pressure based feedback, fluid viscosity change based feedback, etc. In conjunction with, or instead of, the haptic interface 214, the control panel 196 or other graphic display may display forces accumulated on the elongated medical instrument 26 as it is moved via the master input device 194.

[0160] The master input device 194 may optionally include an identifier (ID) 218 ​​(e.g., a bar code, a QR code, or a radio frequency identifier (RFID)) affixed to each of the control elements 200a-200c (or alternatively, each of the sterile covers 208a-208c disposed over the control elements 200a-200c) to allow for rapid identification of the type of elongated medical instrument 26 (e.g., either a guide sheath 26a, a working catheter 26b, or a guidewire 26c) with which each control element 200 is associated. In another embodiment, each control element 200 may be identification (ID) coupled to a corresponding shuttle 72 via the ID 218 (i.e., control element 200a and shuttle 72a are paired, control element 200b and shuttle 72b are paired, and control element 200c and shuttle 72c are paired) and packaged together. In other embodiments, where the actuation of a pair of elongate medical instruments 26 is linked to provide synchronized operation, two of the corresponding control elements 200 may be pre-paired and packaged with a label identifying the linked operation ratio (e.g., 1:1, 2:1, 1:2, etc.) between the pair of elongate medical instruments 26 that the pre-paired control element 200 is designed to actuate.

[0161] The axial translational and rotational movements (and optionally the axial and rotational velocities) of the control elements 200a-200c may be detected via the sensor assembly such that the elongated medical instruments 26a-26c are axially translated and rotationally moved in accordance with the mapping algorithm briefly described above. The sensor assembly outputs signals indicative of the detected axial translation of each of the control elements 200a-200c along the longitudinal axis 204, and signals indicative of the detected rotational movement of each of the control elements 200a-200c about the longitudinal axis 204. The processor 212 may then instruct the endovascular management and tracking system 214 to axially translate and rotationally move each of the elongated medical instruments 26a-26c in response to the control signals output by the sensor assembly.

[0162] In particular, as discussed above, the control elements 200a-200c may be designed to be disposable for single use. In this regard, it is preferred that the relatively inexpensive components of the sensor assembly (e.g., the passive components (i.e., the non-powered components)) reside on or in the control elements 200a-200c (or in each of the sterile covers 208a-208c disposed on the control elements 200a-200c) and the relatively expensive components of the sensor assembly (e.g., the active components (i.e., the powered components)) reside on or in the reusable rail 202 or in another location separate from the control elements 200a-200c. In this manner, the operating costs of the robotic endovascular system 10 can be reduced by replacing only the inexpensive components of the sensor assembly.

[0163] For example, in one embodiment shown in FIG. 18A, the master input device 194 comprises a plurality of encoders in the form of reference elements 219 circumferentially disposed around each of the control elements 200a-200c (or each of the sterile covers 208a-208c disposed over the control elements 200a-200c), and a visual tracking system 221 (e.g., one or more cameras) configured to visually sense the reference elements 219 disposed on the control elements 200a-200c, thereby sensing the axial translational and rotational movement (and optionally the axial and rotational velocities) of each of the control elements 200a-200c.

[0164] In another embodiment shown in Fig. 18B, the master input device 194 comprises a plurality of electromagnetic passive transponders 223, each embedded in a respective one of the control elements 200a-200c (or in a respective one of the sterile covers 208a-208c disposed over the control elements 200a-200c), and a fixed electromagnetic transceiver 225 configured to transmit electromagnetic energy 227 impinging on the electromagnetic passive transponders 223, the fixed electromagnetic transceiver 225 encoding position information, in particular the axial translation (z-position) and rotational movement (roll) of the electromagnetic passive transponders 223 and thus the control elements 200a-200c. The electromagnetic transceiver 225 is capable of receiving the encoded electromagnetic energy 229 emitted by the electromagnetic passive transponders 219 and decoding the electromagnetic energy 229 to determine the axial translation and rotational movement of the control elements 200a-200c. Optionally, if the rail 202 is configured to flex, such that each of the control elements 200a-200c can translate linearly along the x and y directions in addition to the z direction, and can pitch or yaw in addition to rotating, the position information encoded in the electromagnetic energy 229 emitted by the electromagnetic passive transponder 223 can further include the x and y positions, as well as the pitch and yaw of the electromagnetic passive transponder 219 and thus the control elements 200a-200c, thus identifying six degrees of freedom (i.e., x, y, z positions and roll, pitch, yaw) of the control elements 200a-200c.

[0165] 18C, the master input device 194 includes an active array of sensors 231 disposed within and along the longitudinal axis 204 of the rail 202, and a plurality of complementary passive (inactive) elements 233, each disposed within a respective one of the control elements 200a-200c (or within a respective one of the sterile covers 208a-208c disposed over the control elements 200a-200c). Each sensor 231 is disposed adjacent a respective one of the passive elements 233 such that the sensors 231 are capable of sensing the position of the respective passive element 233, and thus the axial translational and rotational movement of the control elements 200a-200c.

[0166] In one particular embodiment, the control elements 200a-200c are constructed of an optically transparent material, and the passive element 233 can be in the form of a series of markings (e.g., a grating) embedded around the perimeter of the control elements 200a-200c. Laser light can be passed through a diffraction grating within the control elements 200a-200c, for example, from a laser source (not shown) located within the rail 202. The diffraction grating encodes the laser light with position information via diffraction, particularly along with the axial (z position) and rotational (roll) movements of the control elements 200a-200c. The sensor 231 is a photodetector that measures the encoded laser light diffracted by the diffraction grating, and can decode the diffracted laser light to determine the axial translational and rotational movements of the control elements 200a-200c.

[0167] In other specific embodiments, the passive elements 233 may be resistors, in which case the sensor 231 can electrically sense the position of each passive element 233 and thus the axial translational and rotational movement of the control elements 200a-200c, or may be ferromagnetic elements, in which case the sensor 231 can magnetically sense the position of each passive element 233, or may be coils, in which case the sensor 231 can inductively sense the position of each passive element 233, or may be capacitive plates, in which case the sensor 231 can capacitively sense the position of each passive element 233, or may be ultrasonic reflective elements, in which case the sensor 231 can ultrasonically sense the position of each passive element 233, etc.

[0168] In yet another embodiment shown in FIGS. 18D-18F, the master input device 194 includes a plurality of mechanical arms 235a-235c, each cantilevered at an end of a respective one of the control elements 200a-200c, and a sensor box 237 having sensors (not shown) within which the free ends of the mechanical arms 235a-235c functionally interact (e.g., optically, electrically, magnetically, inductively, capacitively, ultrasonically, etc.). The length of each of the mechanical arms 235a-235c depends on the relative positions of the control elements 200a-200c on the rail 202. That is, the length of the mechanical arm 235a cantilevered to the distal-most control element 200a is relatively short, the length of the mechanical arm 235c cantilevered to the proximal-most control element 200c is relatively long, and the length of the mechanical arm 235b cantilevered to the intermediate control element 200b is relatively medium. To ensure that the mechanical arms 235a-235c do not mechanically interfere with one another when any of the control elements 200a-200c are rotated about the longitudinal axis 204 of the rail 202, the mechanical arms 235a-235c are clocked relative to one another (e.g., 120 degrees apart from one another) and have a limited range of rotation (e.g., 120 degrees), as best shown in FIG. 18F. If the maximum number of control elements 200 that can be placed on the rail 202 is more or less than three, the mechanical arms 231 may be clocked by a different amount relative to one another and have a different limited range (e.g., 180 degrees when the maximum number of control elements 200 that can be placed on the rail 202 is two, and 90 degrees when the maximum number of control elements 200 that can be placed on the rail 202 is four).

[0169] In any of the embodiments shown in Figures 18A-18F, a relatively inexpensive accelerometer (not shown) may optionally be incorporated into each of the control elements 200a-200c so that the linear and / or angular velocity of the control elements 200a-200c can be determined.

[0170] In yet another embodiment shown in FIGURE 18G, instead of having physical control elements 200a-200c, the master input device 194 includes a three-dimensional (3D) touchscreen 239 that displays an interactive 3D representation of a linear array of virtual control elements 200a'-200c'. In the illustrated embodiment, the 3D touchscreen 239 is cylindrical or semi-cylindrical, upon which an arcuate portion of the linear array of virtual control elements 200a'-200c' is displayed. In alternative embodiments, the 3D touchscreen 239 may have a cross-sectional shape other than circular or arcuate, including polygonal shapes such as, for example, triangles, squares, hexagons, octagons, etc.

[0171] In the illustrated embodiment, the touch screen 239 is cylindrical or semi-cylindrical and displays at least an arcuate portion of the linear array of control icons 200a'-200c'. The arcuate touch screen 239 may be, for example, resistive or capacitive, and may have, for example, an organic light emitting diode (OLED) touch sensitive surface. The surface of the 3D touch screen 239 is divided into separate illuminated areas corresponding to the control icons 200a'-200c'. Any of the control icons 200a'-200c' may be touched to allow the operator 24 to manipulate that control icon. In the illustrated embodiment, the separate illuminated areas have contours so that the operator 24 can easily distinguish the control icons 200a'-200c' from one another. In other embodiments, the different areas may be illuminated with different colors or patterns.

[0172] Thus, while grasping a distinct area of ​​the 3D touchscreen 239 corresponding to one of the control icons 200a'-200c' in a manner similar to grasping one of the physical control elements 200a-200c shown in Figure 18, the operator 24 may move his / her hand along the longitudinal axis of the 3D touchscreen 239 and / or circumferentially about the 3D touchscreen 239, which emulates axial and / or rotational movement of a physical control element. As the operator 24 moves his / her hand along the longitudinal axis of the 3D touchscreen 239, the selected one of the control elements 200a'-200c' may be displayed statically on the 3D touchscreen 239 or may be dynamically displayed moving linearly along the 3D touchscreen 239 with the hand of the operator 24, thereby providing a better indication of the axial positions of the elongated medical instruments 26a-26c relative to one another.

[0173] The axial and rotational hand movements of the operator 24 can be sensed by the 3D touch screen 239, and the elongated medical instruments 26a-26c can be moved axially and rotationally according to a mapping algorithm that uses the sensed axial translational and rotational hand movements of the operator 24 as input and operation of motors (not shown) included in each shuttle 72a-72c as output, as described in further detail below.

[0174] In an alternative embodiment shown in FIG. 18H, rather than displaying arc-shaped control icons 200a′-200c′ that can be effectively grasped by operator 24, 3D touch screen 239 may display control icons 200a″-200c″ (e.g., rectangular) designed to be moved using the fingertip of operator 24. For example, any of control icons 200a″-200c″ may be moved along an axis of 3D touch screen 239. For example, operator 24 may move his / her hand along the longitudinal axis of 3D touch screen 239 and / or circumferentially around 3D touch screen 239 while touching one of control icons 200a″-200c″ with a fingertip, which emulates axial and / or rotational movement of a physical control element.

[0175] Although control station 16, including master input device 194 and control panel 196, have been described and illustrated as being physical devices that exist in the real world and thus can be physically touched by operator 24, in alternative embodiments, one or both of the master input device and control panel of control station 16 may be virtual, such that operator 24 does not need to touch the physical master input device or control panel, reducing hygiene and space concerns.

[0176] For example, referring to FIG. 18I, the control station 16 may include a head-mounted extended reality (XR) device (e.g., a virtual reality (VR), augmented reality (AR), or mixed reality (MR) device) 241 configured to present digitally rendered images to the operator 24 in a three-dimensional (3D) environment such that the operator 24 perceives the digitally rendered images as real. In particular, the XR device 241 is configured to display a virtual master input device 194' having virtual control elements 200a'-200c' in the 3D environment of the operator 24. Thus, the operator 24 can virtually interact with the virtual control elements 200a'-200c' of the virtual master input device 194' as if the operator 24 were physically interacting with the control elements 200a'-200c of the master input device 194 shown in FIG.

[0177] The XR device 241 may also display a control panel (not shown) as a two-dimensional (2D) image, or may display real-time medical images (e.g., fluoroscopic images) of the vascular target site of the patient 20 and a video of the room environment including the endovascular management and tracking system 14', for example, in a corner of the screen of the XR device 241. Alternatively, the XR device 241 may display a virtual control panel (not shown) in the 3D environment of the operator 24. In other embodiments, the XR device has an "optical see-through" display through which the operator 24 can directly view the room environment, or a "video see-through" display in which a video of the room environment is presented mixed with virtual content including the virtual master input device 194' (with or without rails).

[0178] The control station 16 further includes haptic feedback gloves 243 (e.g., HaptX™ gloves) that can be worn on the hands of the operator 24 to capture hand gestures made by the operator 24 while virtually interacting with the virtual control elements 200a′-200c′ of the virtual master input device 194′. Such hand gestures can include, for example, grasping one of the virtual control elements 200a′-200c′ with the hands of the operator 24 and moving the grasping hand along the axes of the virtual master input device 194′ or rotating the grasping hand about the axes of the master input device 194′ in the same manner that the operator 24 physically grasps one of the physical control elements 200a-200c of FIG. 18 and moves the physical control element along the axes of the physical master input device 194 or rotates the grasping hand about the axes of the physical master input device 194. The captured hand gestures are output by the MR device 241 to the processor 212, which can interpret the hand gestures and issue commands to the endovascular management and tracking system 14 according to a mapping algorithm that maps the interpreted hand gestures to desired axial translational and rotational movements of the elongated medical instruments 26a-26c. The haptic feedback glove 243 also functions as a haptic interface 214 (shown in FIG. 18) for providing haptic feedback to the operator 24 as the operator 24 virtually interacts with the virtual control elements 200a'-200c' of the virtual master input device 194' such that the operator 24 feels resistance representative of the direction and magnitude of forces applied to the elongated medical instrument 26 as it is moved within the vasculature of the patient 20.

[0179] 18J, instead of the haptic feedback gloves 243, the control station 16 includes a stationary gesture monitoring system 245 (e.g., a device similar to the sensors of an Xbox Kinect™ or a light detection and ranging (LIDAR) sensor assembly) and one or more haptic ultrasound pads 247. The gesture monitoring system 245 is configured to capture hand gestures made by the operator 24 while virtually interacting with the virtual control elements 200a′-200c′ of the virtual master input device 194′ and provide the captured hand gestures to the processor 212 for interpretation. In an alternative embodiment, the XR device 241 includes a forward-facing camera (not shown) configured to capture images of hand gestures made by the operator 24 while virtually interacting with the virtual control elements 200a′-200c′ of the virtual master input device 194′ and provide the captured hand gesture images to the processor 212 for interpretation. In any embodiment, the operator 24 may wear gloves (not shown) covered with reference elements that can be sensed by the stationary gesture monitoring system 245 or alternatively the forward-facing camera of the XR device 241 to capture hand gestures made by the operator 24.

[0180] The tactile ultrasound pads 247 function as a haptic interface 214 (shown in FIG. 18) by emitting ultrasonic pressure waves that exert a force on the hand of the operator 24, thereby providing haptic feedback to the operator 24 as the operator 24 virtually interacts with the virtual control elements 200a'-200c' of the virtual master input device 194', thereby causing the operator 24 to feel a resistance representative of the direction and magnitude of force applied to the elongated medical instrument 26 as it is moved within the vasculature of the patient 20. In the illustrated embodiment, multiple ultrasound pads 247 are oriented in different directions to provide directionality in the haptic feedback provided to the operator 24.

[0181] As yet another example, referring to FIGURE 18K, instead of an XR system, the control station 16 includes a two-dimensional (2D) display screen 249 that displays a virtual master input device 194' and optionally a virtual control panel (not shown). A stationary gesture monitoring system 245 captures hand gestures made by the operator 24 while the operator 24 views the master input device 194 displayed on the display screen 249 and provides the captured hand gestures to the processor 212 for interpretation. In addition to issuing commands to the endovascular management and tracking system 14, the processor 212 can respond to the captured hand gestures made by the operator 24 by, for example, moving the displayed control elements 202a-202c in accordance with the hand gestures or augmenting the displayed control elements 202a-202c, for example with different colors, to augment the master input device 194.

[0182] As yet another example, referring to FIG. 18L, instead of an XR system, the control station 16 includes a virtual master input device 194' having virtual control elements 200a'-200c', and optionally a holographic machine 251 configured to display the virtual control panel in the 3D environment of the operator 24. Rather than displaying the virtual master input device 194' on a head mounted display as in an XR system, the holographic machine 251 projects the virtual master input device 194' into the 3D environment of the operator 24. The operator 24 can interact with the virtual control elements 200a'-200c' of the virtual master input device 194' in the same manner as described above with respect to the XR device 241 of FIG. 18I. Hand gestures can be captured, for example, by haptic feedback gloves 243 (shown in FIG. 18I) or a stationary gesture monitoring system 245 (shown in FIG. 18J) worn on the hands of the operator 24. Tactile feedback may be provided to operator 24, for example, by tactile feedback gloves 243 (shown in FIG. 18I) or tactile ultrasound pads 247 (shown in FIG. 18J) worn on the hands of operator 24.

[0183] These nominal axial translation and rotational movement positions are preferably at the center of the axial translation and rotational movement ranges, such that the control elements 200a-200c can have positive and negative ranges of movement from the nominal positions (i.e., a positive axial translation range, a reverse axial translation range, a clockwise rotational movement range, and a counterclockwise rotational movement range).

[0184] Much like the physical control elements 200a-200c described above, each of the virtual control elements 200a'-200c' in any of the embodiments described above may be virtually axially and rotationally spring loaded so as to return to their nominal axial translation and rotational translation positions when virtually released by the operator 24. These nominal axial translation and rotational translation positions are preferably at the centers of the axial translation and rotational translation ranges, such that the control elements 200a'-200c' may have positive and negative ranges of movement from the nominal position (i.e., a positive axial translation range, a reverse axial translation range, a clockwise rotational movement range, and a counterclockwise rotational movement range).

[0185] Although the master input devices 194, 194' shown in Figures 18A-18L have been described as controlling the catheter tracking and management system 14 shown in Figures 1-17, it should be understood that the master input devices 194, 194' shown in Figures 18A-18L may be employed to control any robotic catheter system in which elongated medical instruments can move axially and rotationally relative to one another, including those that do not have shuttles that are coaxially arranged and translate along a track.

[0186] As briefly described above, the processor 212 may issue instructions to the endovascular management and tracking system 14 according to a mapping algorithm that maps sensed axial translational and rotational movements of the control elements 200a-200c (or virtual control elements 200a'-200c') to desired axial translational and rotational movements of the elongated medical instruments 26a-26c. That is, in response to inputs including axial translational or rotational movements of the control elements 200a-200c (or virtual control elements 200a'-200c'), the mapping algorithm outputs desired axial translational or rotational movements of the elongated medical instruments 26a-26c. The processor 212 may then translate the output of the mapping algorithm into commands that are sent to the endovascular management and tracking system 14, and in particular, to the motors of the endovascular management and tracking system 14, to facilitate these desired axial translational or rotational movements.

[0187] As briefly described above, the control elements 200a-200c may be axially and rotationally spring loaded to return to their nominal axial translation and rotational translation positions when physically released by the operator 24, or the virtual control elements 200a'-200c' may be virtually axially and rotationally spring loaded to return to their nominal axial translation and rotational translation positions when virtually released by the operator 24. In this embodiment, the mapping algorithm only causes each of the elongated medical instruments 26a-26b to translate axially (proximally or distally) or rotate (clockwise or counterclockwise) in response to axial or rotational movement away from the neutral position of the corresponding control element 200 (i.e., against a physical or virtual spring force). In this manner, no axial translation or rotational movement of the elongate medical instruments 26a-26c occurs in response to the operator 24 physically releasing the control elements 200a-200c or virtually releasing the virtual control elements 200a'-200c'. Repeated axial or rotational movement and subsequent release of the control elements 200, or virtual axial or rotational movement and subsequent virtual release of the virtual control element 200', may result in incremental axial or rotational movement of the corresponding elongate medical instruments 26.

[0188] In one embodiment, the mapping algorithm outputs an axial translation of each elongate medical instrument 26 according to the axial translation ratio in response to an input of an axial translation of the corresponding control element 200 (or virtual control element 200'), and similarly outputs a rotational translation of each elongate medical instrument 26 according to the rotational translation ratio in response to an input of a rotational translation of the corresponding control element 200 (or virtual control element 200'). In general, the axial translation ratio and the rotational translation ratio are positive. That is, the mapping algorithm outputs a distal axial translation of each elongate medical instrument 26 in response to an input of a distal axial translation of the corresponding control element 200 (or virtual control element 200'), and outputs a proximal axial translation of each elongate medical instrument 26 in response to an input of a proximal axial translation of the corresponding control element 200 (or virtual control element 200'). Similarly, the mapping algorithm outputs a clockwise rotational movement of each elongate medical instrument 26 in response to an input of a clockwise rotational movement of the corresponding control element 200 (or virtual control element 200'), and outputs a counterclockwise rotational movement of each elongate medical instrument 26 in response to an input of a counterclockwise rotational movement of the corresponding control element 200 (or virtual control element 200').

[0189] The rotational movement ratio is preferably 1:1 or 1 (i.e., the rotational movement of each elongate medical instrument 26 exactly tracks the rotational movement of the corresponding control element 200 (or virtual control element 200')). In contrast, the axial translation ratio is desirably greater than or less than 1:1 (i.e., the axial translation of each elongate medical instrument 26 is less than the axial translation of the corresponding control element 200 (or virtual control element 200')). For example, when the corresponding control element 200 (or virtual control element 200') translates axially 1 cm, the elongate medical instrument 26 may translate axially 1 mm (i.e., a 10:1 ratio). However, in alternative embodiments, the rotational movement ratio may be different from 1:1 or 1, and the axial translation ratio may be 1:1 or 1.

[0190] Either or both of the axial translation ratio and the rotational movement ratio may be constant such that there is a linear relationship between the axial translation or rotational movement of the control element 200 or the virtual control element 200' input to the mapping algorithm and the axial translation or rotational movement of the corresponding elongated medical instrument 26, respectively, output by the mapping algorithm. Alternatively, either or both of the axial translation ratio and the rotational movement ratio may vary over time such that there is a non-linear relationship between the axial translation or rotational movement of the control element 200 or the virtual control element 200' input to the mapping algorithm and the axial translation or rotational movement of the corresponding elongated medical instrument 26, respectively, output by the mapping algorithm. For example, it may be desirable for the axial translation or rotational movement ratio to be initially high (e.g., to quickly overcome static friction forces between the elongated medical instrument 26 and the vasculature) and then decrease. As another example, the axial translation or rotational movement ratio may vary according to a custom profile designed for a particular operator 24. Such a custom profile may be created manually, or it may be generated via a calibration procedure, or dynamically adapted to a particular operator 24 over a period of time.

[0191] The mapping algorithm may adjust either or both of the axial translation ratio and the rotational movement ratio, for example, to provide smooth axial or rotational movement of the elongated medical instruments 26a-26c. For example, tremors in the operator 24's hands may cause the control element 200 or the virtual control element 200' to translate axially or rotate. The mapping algorithm may smooth (e.g., via integration) the disjointed axial or rotational movement inputs of the control element 200 or the virtual control element 200' such that the desired axial or rotational movement output of the corresponding elongated medical instrument 26 has a low amplitude axial or rotational vibration, for example, to avoid static frictional forces between the elongated medical instrument 26 and the vasculature of the patient 20, thereby facilitating distal advancement of the elongated medical instrument 26.

[0192] In another embodiment, rather than using an axial translation ratio or a rotational movement ratio, the mapping algorithm may output an axial velocity of each elongate medical instrument 26 in response to an input of an axial translation of the corresponding control element 200 (or virtual control element 200'), and similarly, a rotational velocity of each elongate medical instrument 26 in response to an input of a rotational movement of the corresponding control element 200 (or virtual control element 200'). In general, the axial velocity will be in the same direction as the axial translation of the corresponding control element 200 (or virtual control element 200') and the rotational velocity will be in the same direction as the rotational movement of the corresponding control element 200 (or virtual control element 200'). That is, the mapping algorithm outputs a distal axial velocity of each elongate medical instrument 26 in response to an input of a distal axial translation of the corresponding control element 200 (or virtual control element 200'), and outputs a proximal axial velocity of each elongate medical instrument 26 in response to an input of a proximal axial translation of the corresponding control element 200 (or virtual control element 200'). Similarly, the mapping algorithm outputs a clockwise rotational velocity of each elongate medical instrument 26 in response to an input of a clockwise rotational movement of the corresponding control element 200 (or virtual control element 200'), and outputs a counterclockwise rotational velocity of each elongate medical instrument 26 in response to an input of a counterclockwise rotational movement of the corresponding control element 200 (or virtual control element 200').

[0193] In one embodiment, the mapping algorithm outputs a uniform axial or rotational velocity for each elongated medical instrument 26 in response to any axial or rotational movement of the corresponding control element 200 (or virtual control element 200'). In another embodiment, the mapping algorithm outputs an axial or rotational velocity for each elongated medical instrument 26 that varies depending on the extent or speed at which the corresponding control element 200 (or virtual control element 200') is axially or rotationally moved. For example, if the control element 200 (or virtual control element 200') is axially or rotationally moved a relatively long distance or relatively fast, the mapping algorithm may output a relatively high axial or rotational velocity for the corresponding elongated medical instrument 26. In contrast, if the control element 200 (or virtual control element 200') is axially or rotationally moved a relatively short distance or relatively slow, the mapping algorithm may output a relatively low axial or rotational velocity for the corresponding elongated medical instrument 26. In yet another embodiment, the mapping algorithm outputs an axial or rotational velocity of each elongated medical instrument 26 that varies according to a custom profile designed for a particular operator 24. Such a custom profile may be created manually, or may be generated via a calibration procedure or dynamically adapted to a particular operator 24 over a period of time.

[0194] 21-24, one detailed embodiment of an endovascular management and tracking system 14' is described. Similar to the catheter and tracking system 14 shown in FIG. 6, the endovascular management and tracking system 14 generally includes a plurality of track segments 70' (only one shown) and a plurality of shuttles 72' (only one shown) mechanically coupled to the track segment 70' and configured to be translated axially along the track segment 70'.

[0195] Although only one track segment 70' is shown in FIGS. 21-24, it should be understood that each track segment 70' is specifically designed such that multiple track segments 70' can be removably coupled to one another to create tracks of variable length. Thus, the track can be lengthened by adding one or more track segments 70' and shortened by subtracting one or more track segments 70'. This allows the track to better fit the environment of a hospital room. For example, for the particular hospital environment in which the endovascular management and tracking system 14' is to be installed, the overall length of the track can be customized to the contour distance between the control station 16 (shown in FIGS. 1-2) (or anchor to which the proximal end of the track is attached) and the sheath anchor 80 (shown in FIG. 6) that is attached directly or indirectly to the patient 20 and to which the distal end of the track is attached.

[0196] With further reference to Figures 25-29, in contrast to the track 70 shown in Figure 6 which is described as taking the form of a simple rail, each track segment 70' comprises a track rack 220 and a track rail 222 fixed to the track rack 220. The track rack 220 includes an elongated base 224 configured to rest stably on the drape 22 (shown in FIGS. 1-2) and one or more pedestals 226 (best shown in FIGS. 26 and 28-29) secured above the base 224 and to which the track rails 222 are secured. In this manner, the track rails 222 can be elevated above the drape 22 to allow the shuttle 72' to travel freely along the track rails 222 without interfering with the hospital room environment, and in particular with the drape 22 on which the track segments 70' rest.

[0197] In the illustrated embodiment, the base 224 takes the form of a rectangular frame having a pair of elongated frame members 228 and a series of crossbars 230 (best seen in FIGS. 25 and 27) that secure the pair of elongated frame members 228 to one another, specifically spaced periodically across the width of the base 224 and along the length of the base 224. The base 224 is planar such that the track segments 70', such as the track 70 illustrated in FIG. 6, are relatively flexible from top to bottom (vertically) but relatively less flexible laterally (horizontally) and torsionally (i.e., have high horizontal and torsional stiffness). In this manner, the track segments 70' respond only to gravity (e.g., when resting on the treatment table 18, patient 20, and / or drape 22) to better conform to the contours of the hospital environment, while the shuttle 72' is able to apply the necessary driving force to the track 70' to translate the shuttle 72' axially along the coupled track segments 70'. It should be noted that the horizontal and torsional stiffness of the track segment 70' can be adjusted without significantly altering the vertical flexibility of the track segment 70' by varying the number of crossbars 232 that secure the elongated frame members 228 together. That is, increasing the number of crossbars 232 used to secure the elongated frame members 230 together correspondingly increases the horizontal and torsional stiffness of the track segment 70', and decreasing the number of crossbars 230 used to secure the elongated frame members 228 together correspondingly decreases the horizontal and torsional stiffness of the track segment 70'. In the illustrated embodiment, a plurality of pedestals 226 are disposed along the center of the crossbars 232.

[0198] Similar to track 70, track rail 222 takes the form of an open monorail on which shuttle 72' rides and may be a ribbon-like element (a wide, thin rectangular extrusion) having a rectangular cross section, as best seen in FIG. 27. Similar to track 70, each track segment 70' includes at least one row of teeth 84' extending along the length of track rail 222, and in the illustrated embodiment includes one row of teeth 84', with which a corresponding drive mechanism for shuttle 72' engages to provide axial translation of shuttle 72' along track segment 70'. As will be explained in more detail below, track rail 222 with teeth 84' disposed thereon functions as a rack in a rack and pinion arrangement for translating shuttle 72' along track segment 70'.

[0199] As briefly described above, a plurality of track segments 70' may be removably coupled to one another. To this end, the track segments 70' include a pair of track couplers 232 disposed at opposite ends of each track segment 70', in the illustrated embodiment at opposite ends of the track rails 222 of each track segment 70'. The track couplers 232 are complementary to one another such that the track segments 70' may be removably coupled to one another by engagement of corresponding couplers 232 of adjacent track segments 70'.

[0200] For example, in the illustrated embodiment, track coupler 232a disposed at proximal end 234a of track rail 222 includes a recess 236 (best shown in FIGS. 25 and 28) formed in a bottom surface of track rail 222 and a tab 238 extending from proximal end 234a of track rail 222. In contrast, track coupler 232b disposed at distal end 234b of track rail 222 includes a recess 236 (best shown in FIGS. 27 and 29) formed in a top surface of track rail 222 and a tab 238 extending from distal end 234b of track rail 222. The recess 236 and tab 238 each have the same shape. In this manner, the track segments 70' can be removably coupled to one another by engagement of corresponding recesses 236 and tabs 238 of adjacent track segments 70' (i.e., as illustrated in FIG. 28 , a tab 238 on a proximal end 234a of a track rail 222 of one track segment 70' can engage (e.g., snap-fit) with a corresponding recess 236 on a distal end 238b of a track rail 222 of another track segment 70'), thereby coupling the track segments 70' to one another. The track segments 70' can be separated from one another by disengaging the corresponding recesses 236 and tabs 238 of adjacent track segments 70' (i.e., a tab 238 on a proximal end 234a of a track rail 222 of one track segment 70' can be disengaged (e.g., snap-out) from a corresponding recess 236 on a distal end 238b of a track rail 222 of the other track segment 70', thereby separating the track segments 70' from one another). Alternatively, other types of corresponding track couplers 232 may be utilized to removably couple multiple track segments.

[0201] 30-32, similar to each of the shuttles 72a-72c shown in FIGS. 6 and 7A-7D, the shuttle 72′ includes a sled 90′ (also shown in FIG. 21) configured to ride on the track segment 70′, an axial drive mechanism 92′ (e.g., a geared or friction coupling) carried by the sled 90′ and configured to be actuated to axially translate the shuttle 72′ (and thus the elongated medical instrument 26 attached to the respective shuttle 72′), an axial actuator 94′ (in this example, a motor) carried by the sled 90′ and configured to actuate the axial drive mechanism 92′, and an axial actuator 95′ (in this example, a motor) carried by the sled 90′ and configured to actuate the axial drive mechanism 92′. 21-23 )。 An anti-buckling mechanism 132' mounted on the sled 90' and configured to prevent backout of the elongated medical device 26 in response to axial compression applied to the elongated medical device 26 (e.g., to prevent backout of the elongated medical device 26 when the shuttle 72' is moved axially in a distal direction or when a subsequent shuttle (not shown) through which the elongated medical device 26 passes is moved axially in a proximal direction). An outer casing 100' (best shown in FIGS. 21-23 ) mounted on the sled 90' and containing one or more of the axial drive mechanism 92', the axial motor 94', the rotational drive mechanism 96', and the rotational motor 94' (in this example, the axial drive mechanism 92', the axial motor 94', and the rotational motor 94').

[0202] In the illustrated embodiment, outer casing 100' includes an upper casing portion 100a' that is attached to the top of sled 90' and a lower casing portion 100b' that is attached to the bottom of sled 90'. As best shown in FIGS. 30-32, lower casing portion 100b' includes an open channel 240 in which track segment 70' is slidably received. The cross-section of open channel 240 has a close tolerance to the cross-section of track rail 222 of the other track segment 70' to allow shuttle 72' to stably run along track segment 70'.

[0203] In the illustrated embodiment, each of the motors 94', 98' takes the form of a stepper motor, although in alternative embodiments, the motors 94', 98' may take the form of any motor that can be controlled in response to electrical control signals, such as signals sent by the control station 16 (shown in FIGS. 1 and 2). As best shown in FIGS. 31-32, each of the motors 94', 98' includes a motor box 242, a stator, rotor, and motor electronics (not shown) housed within the motor box 242, and a motor shaft 244 secured to the rotor within the motor box 242. The shuttle 72' further includes a motor mount bracket 246 that mounts the motors 94', 98' to the sled 90'. In the illustrated embodiment, the motor mount bracket 246 and the sled 90' are of one-piece design, although in alternative embodiments, the motor mount bracket 246 may be secured directly to the sled 90' via suitable fasteners (e.g., screws) to stably support the respective motors 94', 98' relative to the sled 90'.

[0204] The axial drive mechanism 92' will now be described in more detail with reference to Figures 33-39. In this embodiment, the axial drive mechanism 92' takes the form of a drive train including a worm screw 248 fixed to a motor shaft 244 of an axial motor 94', a worm-cog gear 250 operatively coupled to the worm screw 248, a cog gear 254 operatively coupled to the worm-cog gear 250, and a pinion gear 256 (shown in Figures 34 and 36-39) operatively coupled in a rack and pinion arrangement between the cog gear 254 and the teeth 84' (shown in Figures 25-27) of the track segment 70'. The worm screw 248 drives a worm-cog gear 250 which in turn drives a cog gear 254 which drives a pinion gear 256 which engages the teeth 84' of the track segment 70' to translate the shuttle 72' axially along the track segment 70'. The shuttle 72' further includes a gear support bracket 258 (shown in FIGS. 31-32 and 36) suitably attached to the sled 90' via fasteners (not shown) for stable integration of the axial drive mechanism 92'.

[0205] The worm screw 248 includes a bore 260 in which the motor shaft 244 of the axial motor 94' is secured such that the worm screw 248 rotates with the motor shaft 244. The worm-cog gear 250 is secured by a gear support bracket 258 for rotation about an axis 90 degrees from the axis of the motor shaft 244. In particular, the worm-cog gear 250 includes an axial shaft 262 and a bore 264 in which the axial shaft 262 is mounted. One end of the axial shaft 262 is rotatably disposed within a through hole 266 in the gear support bracket 258 (shown in FIGS. 31 and 36), and the other end of the axial shaft 262 is rotatably disposed within an annular flange 268 formed in the thread 90' (shown in FIG. 36), thereby providing lateral support for the worm-cog gear 250.

[0206] The worm screw 248 includes a helical thread 270, and the worm-cog gear 250 includes a worm gear 272 having an arrangement of angled teeth 274 that mesh with the helical thread 270 of the worm screw 248 such that rotation of the worm screw 248 causes rotation of the worm-cog gear 250 about an axis that is 90 degrees from the axis of the motor shaft 244. The worm-cog gear 250 further includes a cog wheel 276 integral with the worm gear 272, which rotates integrally with the worm gear 272. The worm gear 272 partially seats and rotates within a circular recess 284 (shown in FIGS. 33 and 36) formed in the thread 90' around the periphery of the annular flange 268 to provide added axial stability to the worm-cog gear 250.

[0207] The cog gear 254 includes an arrangement of teeth 286 that mesh with the teeth 278 of the cog wheel 276 such that rotating the cog wheel 276 in one direction rotates the cog gear 254 in the opposite direction. Rotation of the cog gear 254 rotates the pinion gear 256. In particular, the cog gear 254 is mechanically coupled to the pinion gear 256 via a shaft 288 that is coaxially attached to the cog gear 254 and the pinion gear 256. The cog gear 254 and the pinion gear 256 include respective bores 290, 292 (best seen in FIG. 36 ) that slidably receive the shaft 288. The shaft 288 and the bores 290, 292 have a non-circular cross-section, in this case a hexagonal cross-section, to provide an interference fit between the gears 254, 256 and the shaft 288 such that rotation of the cog gear 254 causes a corresponding rotation of the pinion gear 256. The pinion gear 256 includes an array of teeth 294 that match and mesh with the teeth 84' of the track segment 70' (shown in FIGS. 25-27) such that rotation of the pinion gear 256 translates the shuttle 72' in a linear direction along the track segment 70'. The pinion gear 256 is disposed between the threads 90' and a recess 296 formed in the lower casing portion 100b' in alignment with the teeth 84' of the track segment 70'. An opening 298 (best shown in FIGS. 30 and 36) is formed between the recess 296 and the open channel 240 of the lower casing portion 100b', thereby exposing the teeth 84' of the track segment 70' for engagement by the teeth 274 of the pinion gear 256. One end of shaft 288 extends through a through hole 300 (best seen in FIGS. 33 and 36) formed in sled 90' and then through a through hole 302 (shown in FIG. 24) in lower casing portion 100b'. Shuttle 72' includes a thrust plate 302 (best seen in FIGS. 33 and 36) that resides within through hole 300 in sled 90 to securely retain pinion gear 256 within recess 296 in lower casing portion 100b'.

[0208] Similar to the endovascular management and tracking system 14 shown in FIG. 6, the endovascular management and tracking system 14' can be advantageously designed to be dynamically switched between a fully automated modality and a fully manual modality. To this end, the shuttle 72 includes a manual clutched axial actuator 102' (shown in FIGS. 21-23) that is similar to the manual axial actuator 102 of each of the shuttles 72a-72c shown in FIGS. 7A-7D in that the manual axial actuator 102' can be manually operated to axially index the shuttle 72' to provide fine control over the axial movement of the shuttle 72' along the track segment 70'. However, the manual clutched axial actuator 102' is further configured to be operated to alternately engage and disengage at least a portion of the axial drive mechanism 92' with respect to the track 70, in this case by alternately engaging and disengaging complementary cogs 254, 254 with one another.

[0209] In particular, the axial actuator with manual clutch 102' comprises a knob 304 (best shown in FIG. 36) and a sleeve 306 having a bore 310 through which the shaft 288 passes, the bore 310 coinciding with the bore 290 of the cog gear 254 such that the sleeve 306 is slidably disposed on the shaft 288. The sleeve 306 is mechanically coupled between the knob 304 and the cog gear 254. For example, the sleeve 306 and the cog gear 254 may be formed as a single piece while the knob 304 is secured to the sleeve 306 via a threaded arrangement 308. As best shown in FIGS. 31-32, the sleeve 306 extends through a through opening 312 formed in the gear support bracket 258 and then through a through opening 314 (shown in FIGS. 40 and 42-43) formed in the upper casing portion 100a', thereby providing lateral support to the sleeve 306 and, therefore, the shaft 288. In this manner, the knob 304 can be axially displaced to alternately engage (see FIG. 35) and disengage (see FIG. 34) from the cog gear 254. In the illustrated embodiment, the knob 304 can be pushed to engage the cog gear 254 with the cog gear 254, and pulled to disengage the cog gear 254 from the cog gear 254.

[0210] Thus, as shown in FIG 35, when the cog gear 254 engages the cog wheel 276 by displacing the knob 304 (shown in FIG 36) and thus the sleeve 306 in the axial direction 252a, the endovascular management and tracking system 14 becomes an automated modality where the axial motor 94' can be actuated to automatically translate the shuttle 72' along the track segment 70'. In this condition, the shuttle 72' can also be considered to be stopped or locked in place on the track segment 70' to the extent that the shuttle 72' cannot move along the track segment 70' without commanded movement of the axial motor 94'.

[0211] In contrast, as shown in FIG. 34, when the cog gear 254 is disengaged from the cog wheel 276 by displacing the knob 304 (shown in FIG. 36) and thus the sleeve 306 in the axial direction 252b, the endovascular management and tracking system 14 is in a manual modality, in which operation of the axial motor 94′ cannot automatically translate the shuttle 72′ along the track segment 70′. However, the knob 304 and thus the sleeve 306 can be rotated in a clockwise or counterclockwise direction (see arrow 316 shown in FIG. 34) to manually translate the shuttle 72′ along the track segment 70′. In particular, the bore 310 of the sleeve 306 has a non-circular cross-section that matches the cross-section of the shaft 288 (in this case, hexagonal) such that an interference fit is provided between the sleeve 306 and the shaft 288. In this manner, rotation of knob 304 rotates sleeve 306, which rotates shaft 288, which rotates pinion gear 256, thereby translating shuttle 72' in a linear direction along track segment 70'. Because axial motor 94' and most of axial drive mechanism 92' (i.e., all mechanisms other than pinion gear 256) are decoupled from track segment 70', shuttle 72' may alternatively be moved directly by hand along track segment 70' by rotation of knob 304, without manipulating knob 304, although in a less finely controlled manner.

[0212] The rotary drive mechanism 96' will now be described in more detail with reference to Figures 40-42. In this embodiment, the rotary drive mechanism 96' includes a cog gear 318 attached to the motor shaft 244 of the rotary motor 98' (shown in Figures 31-32) and a cog gear 320 operatively connected to the cog gear 318. The cog gear 318 includes a bore 322 in which the motor shaft 244 of the rotary motor 98' is secured such that the cog gear 318 rotates with the motor shaft 244.

[0213] The cog 320 includes a bore 324 in which a component (not shown in FIGS. 40-41) to which the elongated medical device 26 is attached is secured so that the cog 320 rotates with the motor shaft 244. In the embodiment shown in FIG. 40, the shuttle 72' is for use with an elongated medical device 26 having fluidic capabilities, such as the guide sheath 26a or the working catheter 26b, in which case such a component would be the male Touhy-Borst connector 122 (shown in FIG. 8) of the RHV 112 to which the respective elongated medical device 26 is mechanically and fluidly coupled. Alternatively, if the shuttle 72' is for use with an elongated medical device 26 not having fluidic capabilities, such as the guidewire 26c, such a component would be the collet 56 (shown in FIG. 3) at the proximal end of the respective elongated medical device 26.

[0214] Cog gear 318 drives cog gear 320, which rotates the elongated medical instrument 26 relative to the shuttle 72'. To this end, cog gears 318, 320 each have a configuration of matching and intermeshing teeth 326, 328 such that rotation of cog gear 318 in one direction rotates cog gear 320 in the opposite direction. In the illustrated embodiment, the rotational drive mechanism 96' is exterior to the casing 100, and thus the upper casing portion 100a has an opening 330 through which the cog gear 320 extends with the elongated medical instrument 26 and through which the cog gear 318 extends with a distal portion of the motor shaft 244 of the rotational motor 98'.

[0215] In the illustrated embodiment, each component of the axial drive mechanism 92' and the rotational drive mechanism 96' may be constructed of a suitable rigid material, such as metal (e.g., stainless steel or brass), plastic (e.g., acetal or nylon), or a combination thereof.

[0216] In the embodiment shown in Figures 40-42, the shuttle 72' is used with an elongated medical instrument 26 having fluid capabilities. In this case, the shuttle 72' further comprises an RHV 112, which in the illustrated embodiment is removably mounted within the outer casing 100' so as to be replaceable with a gear 320 mounted around the male Touhy-Borst connector of the RHV 112. As shown in Figure 41, the distal end of the cylindrical tube 118 of the RHV 112 extends through an opening 330. The upper casing portion 100a' comprises an additional opening 332 through which the proximal end of the cylindrical tube 118 of the RHV 112 extends, and an additional opening 334 through which the end of the side arm 124 of the RHV 112 passes.

[0217] As best shown in FIGS. 31-32, the motor mount bracket 246 and the gear support bracket 258 are positioned relative to one another such that the RHV 112 is stably held in place when the upper casing portion 100a' is attached to the sled 90'. In particular, the RHV 112 is nested between the motor mount 254 and the gear support bracket 258, with the cylindrical tube 118 of the RHV 112 positioned within the space 336 between the motor mounts 254 and the side arm 124 of the RHV 112 positioned within the space 338 between the motor mount 254 associated with the axial motor 94' and the gear support bracket 258. Additionally, the cylindrical tube 118 of the RHV 112 may be sandwiched between an inner surface of the upper casing portion 110a' and the space 336 between the motor mounts 254 when the upper casing portion 110a' is secured to the sled 90'. 43, the inner surface of upper casing portion 100a' includes an open arcuate channel 340 for receiving an arcuate segment of cylindrical tube 118 when upper casing portion 100a' is attached to sled 90', thereby preventing lateral movement of RHV 112. The inner surface of upper casing portion 100a further includes a raised arcuate portion 342 configured to securely engage the center of cylindrical tube 118 when upper casing portion 100a' is attached to sled 90'.

[0218] Next, the buckling prevention mechanism 132' will be described in detail with reference to Figures 44 to 49. The buckling prevention mechanism 132' includes a housing 134' formed by a pair of parallel brackets 350a, 350b and a pair of cross supports 352a, 352b, and an axially split sheath 136' wound within the housing 134' and unwound from the housing 134'.

[0219] The anti-buckling mechanism 132' further includes a take-up reel 152' disposed at a proximal end of the housing 134' and, in the illustrated embodiment, rotatably mounted between brackets 350a, 350b. In particular, the take-up reel 152' includes a spool 354, an axle 356, and a shaft 358 that extends through the axle 356 of the take-up reel 152'. The proximal end of the housing 134' is formed with a pair of holes 360, each formed through brackets 350a, 350b, in which both ends of shaft 358 of take-up reel 152' are rotatably disposed, so that the spool 354 can rotate relative to the housing 134' about the axis of rotation 356 of the take-up reel 152' to alternately wind up the flattened proximal portion 148b' of the axially split sheath 136' when being wound into the housing 134' and unwind the flattened proximal portion 148b' of the axially split sheath 136' when being unwound from the housing 134'.

[0220] The anti-buckling mechanism 132' further includes a flattening mechanism 154' disposed within the housing 134' and, in the illustrated embodiment, rotatably mounted between brackets 350a, 350b. In particular, the flattening mechanism 154' includes pinch rollers 154a'-154c' between which the axially split sheath 136' is disposed.

[0221] Pinch roller 154a' includes a drum 362 having a friction surface 364 of uniform diameter, an axle 366, and a shaft 368 extending through the axle 366 of pinch roller 154a'. Drum 362 spans substantially the entire space between brackets 350a, 350b, thereby maximizing the contact area between friction surface 364 and flattened proximal portion 148b' of axially split sheath 136. The distal end of housing 134' includes a pair of holes 370 formed through brackets 350a, 350b, respectively, in which opposite ends of shaft 368 of pinch roller 154a' are rotatably disposed such that drum 362 can rotate about axle 366 of pinch roller 154a' relative to housing 134'.

[0222] Each pinch roller 154b', 154c' includes a wheel 372 having a concave friction surface 374, an axle 376, and a shaft 378 (best seen in FIG. 47) that extends through the axle 376 of each pinch roller 154b', 154c'. The distal end of the housing 134' includes a pair of holes 380 that extend through the brackets 350a, 350b, respectively. The shafts 378 of the pinch rollers 154b', 154c' are rotatably disposed in the holes 380, respectively. The holes 380 in the brackets 350a, 350b are aligned with one another such that the rotational axes 376 of the pinch rollers 154b', 154c' are coaxial and offset from the hole 370 in which the shaft 368 of the pinch roller 154a' is rotatably mounted, such that the pinch rollers 154b', 154c' are offset a distance such that the friction surfaces 364, 374 of the pinch roller 154a' and the drum 362 and wheel 372 contact or are otherwise in close proximity to one another, whereby as the axially split sheath 136' is axially translated in the proximal direction 150' between the pinch rollers 154a' and 154b', 154c', its tubular distal portion 148a' is continuously deformed into its transition portion 148c and then into its flattened proximal portion 148b'.

[0223] Notably, opposing edges 382 of transition portion 148c' of axially split sheath 136' are captured within concave friction surfaces 374 of wheels 372 of pinch rollers 154b', 154c', thereby ensuring that flattened proximal portion 148b' is properly aligned between pinch rollers 154a' and pinch rollers 154b', 154c', and flattening mechanism 154' firmly deforms tubular distal portion 148a' into flattened proximal portion 148b' as axially split sheath 136' moves axially in proximal direction 150'. The cross support 352a is disposed between the take-up reel 152' and the flattening mechanism 154' and has a flat support surface against which the flattened proximal portion 148b' of the axial split sheath 136' slides, thereby ensuring that the flattened proximal portion 148b' of the axial split sheath 136' remains flat between the take-up reel 152' and the flattening mechanism 154'.

[0224] The anti-buckling mechanism 132' further includes a tube forming mechanism 156' disposed at a distal end of the housing 134' distal to the flattening mechanism 154'. The tube forming mechanism 156' includes a ring 384 having an opening 386 in which the axially split sheath 136' is disposed.

[0225] The ring 384 has an arcuate support surface 388 surrounding an opening 386 that contacts the outer surface of the axial split sheath 136'. The diameter of the opening 386 is slightly larger than the diameter of the tubular distal portion 148a' of the axial split sheath 136' but much smaller than the width of the flattened proximal portion 148b' such that as the axial split sheath 136' axially translates in the distal direction 150" through the opening 378 in the ring 384, its flattened proximal portion 148b' is constantly deformed from its transition portion 148c' to its tubular distal portion 148a'. The ring 384 is secured between the brackets 350a, 350b via rigid supports 390.

[0226] As best shown in Figures 44 and 48, the elongated medical device 26' may be loaded into the exposed central lumen 144' of the axially split sheath 136' at the interface between the tubular distal portion 148a' and the transition portion 148c'.

[0227] With reference to FIG. 49, any embodiment of the anti-buckling mechanism 132' further includes a winding bias mechanism 392 configured to bias the take-up reel 152' (shown in FIGS. 44-47) to wind the flattened proximal portion 148b' of the axially split sheath 136' as it is wound into the housing 134'.

[0228] In the illustrated embodiment, the take-up biasing mechanism 392 includes an idler pulley 394 attached to the take-up reel 152' such that the take-up reel 152' rotates in unison with the idler pulley 394. In particular, the idler pulley 394 includes a bore 400 in which the shaft 358 of the take-up reel 152' is secured such that the idler pulley 394 rotates with the take-up reel 152' about the axis of rotation 356 of the take-up reel 152'.

[0229] The winding biasing mechanism 392 further includes a drive pulley 396 configured to rotate as the flattened proximal portion 148b' of the axially split sheath 136' winds into the housing 134'. In the illustrated embodiment, the drive pulley 396 is attached to one of the pinch rollers 154a'-154c', specifically pinch roller 154a' (shown in FIGS. 45-48) (which rotates as the axially split sheath 136' winds into the housing 134'), such that the drive pulley 396 rotates in unison with the pinch roller 154a'. The drive pulley 396 includes a bore 402 through which the shaft 368 of the pinch roller 154a' is mounted for rotation therewith about the axis of rotation 366 of the pinch roller 154a'. In alternative embodiments, the drive pulley 396 may be directly or indirectly coupled to another component (e.g., track 70') that is registered to the axial translation of the axially split sheath 136' as it is wound within the housing 134'.

[0230] The winding biasing mechanism 392 further includes a drive belt 398 connecting the idler pulley 394 to the drive pulley 396 such that the idler pulley 394 rotates in response to rotation of the drive pulley 396. Preferably, the drive pulley 396 drives the idler pulley 394 via the drive belt 398 at a rotational speed that maintains constant tension on the flattened proximal portion 148b' of the axially split sheath 136' as it winds within the housing 134'. Thus, the diameter of the idler pulley 394 is smaller than the diameter of the drive pulley 396 such that the drive pulley 396 overdrives the idler pulley 394.

[0231] 50, it will be appreciated that without intervention, the linear velocity of the wound flat proximal portion 148b' of the axial split sheath 136' (i.e., the portion wound around the take-up reel 152') rotating with the take-up reel 152' will tend to increase as its diameter D increases, which can cause a mismatch in the linear velocity of the tubular distal portion 148a' of the axial split sheath 136' relative to the housing 134' and can upset the anti-buckling feature 132'. Thus, the winding biasing mechanism 392 preferably includes some type of clutch mechanism configured to match the linear velocity of the wound flat proximal portion 148b' with the linear velocity of the axial split sheath 136' relative to the housing 134'.

[0232] In the illustrated embodiment, the clutch mechanism takes the form of a friction clutch between the idler pulley 394 and the drive belt 398. Thus, as the linear speed of the wound flattened proximal portion 148b' of the axial split sheath 136' tends to increase relative to the housing 134' compared to the linear speed of the tubular distal portion 148a' of the axial split sheath 136', the resulting increase in tension in the axial split sheath 136' translates into an increase in tension in the drive belt 398, thereby causing the drive belt 398 to slip relative to the idler pulley 394. Such slippage thus slows the rotational speed of the take-up reel 152', and thus the linear speed of the wound flattened proximal portion 148b' of the axial split sheath 136' to decrease to match the linear speed of the tubular distal portion 148a' of the axial split sheath 136' relative to the housing 134'. As described above, it should be appreciated that the diameter ratio between the drive pulley 396 and the idler pulley 394 can be set (preferably greater than 1 in an overdrive configuration) so that the minimum linear speed of the wound flattened proximal portion 148b' of the axial split sheath 136' is at least slightly greater than the linear speed of the tubular distal portion 148a' of the axial split sheath 136' relative to the housing 134' and so that the flattened proximal portion 148b' of the axial split sheath 136' is under constant tension as it is wound within the housing 134'.

[0233] In any embodiment, the take-up bias mechanism 392 includes a ratchet (not shown) associated with the idler pulley 394 such that as the flattened proximal portion 148b' of the axially split sheath 136' is unwound from the housing 132', the idler pulley 394 spins freely as it unwinds from the take-up reel 152'.

[0234] 51-55, an alternative embodiment of anti-buckling mechanism 132" that can be used with shuttle 72' shown in FIGS. 20-24 is described. Anti-buckling mechanism 132" is similar to anti-buckling mechanism 132' shown in FIGS. 44-49, except that anti-buckling mechanism 132" is more compact in that the distance between the flattening mechanism and the take-up reel is significantly reduced. As a result, the flattened proximal portion of axially split sheath 136' between the flattening mechanism and the take-up reel is more likely to remain flattened.

[0235] The buckling prevention mechanism 132'' includes a housing 134'' formed by a pair of parallel brackets 450a, 450b and a pair of cross supports 452a, 452b, and an axially split sheath 136'' (shown in Figures 44-49) wound within and unwound from the housing 134''.

[0236] The anti-buckling mechanism 132' further includes a take-up reel 152" that is disposed at a proximal end of the housing 134" and, in the illustrated embodiment, is rotatably mounted between brackets 450a, 450b. In particular, the take-up reel 152" includes a spool 454, an axle 456, and a shaft 458 that extends through the axle 456 of the take-up reel 152". The proximal end of the housing 134" includes a pair of holes 460 formed through brackets 450a, 450b, respectively, in which both ends of a shaft 458 of the take-up reel 152" are rotatably disposed, such that the spool 454 can rotate about an axis of rotation 456 of the take-up reel 152" relative to the housing 134" to alternately wind up the flattened proximal portion 148b' of the axially split sheath 136' when being wound into the housing 134" and unwind the flattened proximal portion 148b' of the axially split sheath 136' when being unwound from the housing 134".

[0237] The anti-buckling mechanism 132' further includes a flattening mechanism 154" disposed within the housing 134" and rotatably mounted between brackets 450a, 450b in the illustrated embodiment. In the illustrated embodiment, the flattening mechanism 154" includes pinch rollers 154a", 154b" between which the axially split sheath 136' is disposed.

[0238] Pinch roller 154a" includes a drum 462 having a friction surface 464 of uniform diameter, an axle 466, and a shaft 468 extending through axle 466 of pinch roller 154a". Drum 462 spans substantially the entire space between brackets 450a, 450b, thereby maximizing the contact area between friction surface 464 and flattened proximal portion 148b' of axially split sheath 136. The distal end of housing 134' includes a pair of holes 470 formed through brackets 450a, 450b, respectively, in which opposite ends of shaft 468 of pinch roller 154a" are rotatably disposed such that drum 462 can rotate about axle 466 of pinch roller 154a" relative to housing 134".

[0239] Pinch roller 154b" is dumbbell shaped. In particular, pinch roller 154b" includes a center bar 471 and a pair of enlarged wheels 472 that straddle bar 471, each wheel having a convex friction surface 474, an axle 476, and a shaft 478 that extends through axle 476 of pinch roller 154b". The distal end of housing 134" includes a pair of holes 480 that extend through brackets 450a, 450b, respectively. A shaft 478 of pinch roller 154b" is rotatably disposed in hole 480. Hole 480 in brackets 450a, 450b is offset from hole 470 in which shaft 468 of pinch roller 154a" is rotatably mounted such that pinch roller 154b' is offset perpendicular to their axes of rotation 466, 467 from pinch roller 154a' by a distance such that friction surfaces 464, 474 of drum 462 and wheel 472 contact or are otherwise in close proximity to one another, whereby as axially split sheath 136' is axially translated in the proximal direction 150' between pinch roller 154a" and pinch roller 154b", its tubular distal portion 148a' is deformed continuously to its transition portion 148c' and then to its flattened proximal portion 148b'.

[0240] Notably, opposing edges 382 of transition portion 148c' of axially split sheath 136' wrap around convex friction surfaces 474 of wheels 472 of pinch roller 154b'', thereby ensuring that flattened proximal portion 148b' is properly aligned between pinch rollers 154a'' and 154b'', and flattening mechanism 154'' firmly deforms tubular distal portion 148a' into flattened proximal portion 148b' as axially split sheath 136' moves axially in proximal direction 150'.

[0241] The anti-buckling mechanism 132' further includes a tube forming mechanism 156" disposed at a distal end of the housing 134" distal to the flattening mechanism 154". The tube forming mechanism 156" includes an arch 484 having an opening 486 (best seen in FIG. 52) in which the axially split sheath 136' is disposed. The arch 484 has an arcuate support surface 488 surrounding the opening 486 that contacts the outer surface of the axially split sheath 136'. The diameter of opening 486 is slightly larger than the diameter of tubular distal portion 148a' of axial split sheath 136' but much smaller than the width of flattened proximal portion 148b' such that as axial split sheath 136' axially translates distally 150" through opening 478 in arch 484, its flattened proximal portion 148b' is constantly deformed from its transition portion 148c' to its tubular distal portion 148a'. Arch 484 is fixed between brackets 450a, 450b via rigid supports 490.

[0242] While both catheter tracking and management systems 14, 14' are fully automated in that each of the shuttles is independently translated axially in response to direct input from the operator 24 at the master input device 194 of the control station 16, in alternative embodiments, the catheter tracking and management system may operate in a manual / automatic hybrid (i.e., semi-automatic) mode (also known as an automated assisted system) in which at least one of the shuttles is automatically translated axially along the track in response to the operator 24 manually axially translating another one of the shuttles along the track. Such a master-slave configuration eliminates the need for multiple operators (e.g., a primary operator who is a physician and a secondary operator who is a trained assistant) to perform a medical procedure by using manual operation of one intravascular device by a primary operator to control the automated operation of another intravascular device. Thus, such a semi-automatic master-slave configuration may eliminate the secondary operator, improving the workflow of the medical procedure.

[0243] For example, in one generalized embodiment shown in FIG. 56, one of the shuttles in the catheter tracking and management system 14-1 is the master shuttle 72. m and at least one of the shuttles is a slave shuttle 72 s The Master Shuttle 72 can be designed to m , and therefore Master Shuttle 72 m Long, thin medical instruments attached to 26 m responsive to manual axial translation of the master shuttle 72 along track 70-1 (e.g., m 72 is used to index the axis. m By manually operating the manual actuator of the master shuttle 72 m by directly moving the slave shuttle 72 s , hence the slave shuttle 72 s Long, thin medical instruments attached to 26 s Master Shuttle 72 along track 70-1 m axially translates along track 70-1 in synchronism with the axial translation of elongated medical instrument 26 s Long and thin medical instruments 26 m axially along track 70-1 in synchronization with the axial translation of the

[0244] For example, Slave Shuttle 72 s can be translated axially along the track 70 according to an axial translation ratio (e.g., slave shuttle 72 s Master Shuttle 72 m is translated axially along track 70-1), this may be positive (master shuttle 72 m and Slave Shuttle 72 s are axially translated in the same direction along the track 70), or may be negative (master shuttle 72 m and Slave Shuttle 72 s are axially translated in opposite directions along the track 70).

[0245] Master Shuttle 72 m is illustrated as the trailing (distal) of the shuttles, and slave shuttle 72 s is illustrated as the leading (proximal) of the shuttles, in an alternative embodiment, the master shuttle 72 m is the leading (proximal) shuttle, and the slave shuttle 72 m It should be understood that the master / slave function of any two of the shuttles 72 may be the one trailing (distal) of the shuttle. Furthermore, at any time, the master / slave function of any two of the shuttles 72 may be switched by simply manually translating one of the shuttles 72 but not the other of the shuttles 72. For example, the trailing shuttle may be designated as the slave shuttle 72 by simply manually translating the trailing shuttle. s From Master Shuttle 72 m In this case, the leading shuttle is the master shuttle 72. m From Slave Shuttle 72 s and is translated axially along track 70-1 in synchronism with the axial translation of the trailing shuttle along track 70-1. The leading shuttle is then switched to slave shuttle 72 by manually translating the leading shuttle. s From Master Shuttle 72 m In this case, the following shuttle will be the master shuttle 72 m From Slave Shuttle 72 s and is translated axially along track 70-1 synchronously with the axial translation of the leading shuttle along track 70-1.

[0246] Master Shuttle 72 m and Slave Shuttle 72 s To synchronize the axial displacement between the master shuttle 72 along the track 70-1, m The slave shuttle 72 moves in sync with the axial movement of the s The master shuttle 72 along the track 70-1 moves axially. m responsive to manual axial movement of the slave shuttle 72 sA controller 500 is employed to operate the axial drive mechanism (not shown in FIG. 56).

[0247] In one exemplary embodiment of the catheter tracking and management system 14-1a shown in FIG. 57, such a controller is an electronic controller 500a, which may be, for example, a processor of the control station 16, which communicates with the master shuttle 72 via a wired or wireless connection (e.g., the wired or wireless connection described above for communication between the control station 16 and the shuttles 72a-72c in FIG. 6). m 7, and a master shuttle 72 for the track 70. m In this embodiment, the catheter tracking and management system 14-1 controls the master shuttle 72 relative to the track 70. m and one or more encoders 540 that encode the position of the master shuttle 72 relative to the track 70 by reading the encoders 540. m and one or more sensors 542 configured to output an electrical signal 544 indicative of the position of the sensor 542.

[0248] In one embodiment, the encoder 540 is positioned along the track 70 and the sensor 542 is connected to the master shuttle 72. m For example, the encoder 540 may include a series of reference elements (e.g., similar to reference elements 86 shown in FIGS. 7C-7D) that extend along the length of the track 70, and the sensor 542 may be located on the master shuttle 72. m The controller 500a may include a reference element reader disposed on the slave shuttle 72 (e.g., on the sled 90′ illustrated in FIGS. 30-32) and configured to read (e.g., optically, magnetically, capacitively, etc.) the reference elements 540. s Master Shuttle 72 m based on electrical signal 498 (e.g., slave shuttle 72) to translate axially along track 70-1 in synchronization with s By controlling the second axial driving mechanism 92' (shown in Figs. 31 to 39), the first axial driving mechanism can be controlled.

[0249] As discussed above with respect to reference element 86 shown in FIGS. 7C-7D, reference element 540 is aligned with master shuttle 72. m Alternatively, the reference element sensor 540 may be located on the rotating component of the axial drive mechanism 92' (shown in FIGS. 31-39), while the reference element sensor 540 may be located on the inner surface of the casing 100' (shown in FIGS. 21-23) or on another surface of the master shuttle 72. m In other alternative embodiments, active electronic components (e.g., transmitter / receiver pairs) capable of performing position sensing using signaling (e.g., optical, inductive, capacitive, radio frequency (RF), etc.) may be mounted on the track 70' and master shuttle 72. m In yet another alternative embodiment, the master shuttle 72 m A reference element (not shown) may be located at the distal end of the elongated medical instrument 26 associated with the master shuttle 72 relative to the track 70'. m Rather than directly tracking the position of the elongated medical instrument 26, the position of the elongated medical instrument 26 may be visually sensed by a vision-based system, such as an x-ray fluoroscopic imager (not shown), to directly track the position of the elongated medical instrument 26.

[0250] In another exemplary embodiment of the catheter tracking and management system 14-1b shown in FIG. 58, the controller 500 can be a mechanical controller 500b. In this embodiment, the master shuttle 72 m sled 90 configured to ride on truck 70-1 m And thread 90 m 7, and moves along track 70-1 to master shuttle 72. m , and thus the elongated medical device 26 m axial drive mechanism 92 configured to be actuated to axially translate the m And thread 90 m and an axial drive mechanism 92 m A manual actuator 102 configured to actuate the m Similarly, the slave shuttle 72 ssled 90 configured to ride on truck 70-1 s And thread 90 s 7, and is carried by a slave shuttle 72 along a track 70-1. s , and thus the elongated medical device 26 s axial drive mechanism 92 configured to be actuated to axially translate the s And thread 90 s and an axial drive mechanism 92 s an optional manual actuator 102 configured to actuate the s It is equipped with the following.

[0251] In any embodiment, the master shuttle 72 m Thread 90 m and an elongated medical device 26 m Master Shuttle 72 m The slave shuttle 72 further includes a rotational drive mechanism (not shown) configured to operate to rotate the slave shuttle 72 about its longitudinal axis relative to the slave shuttle 72. s Thread 90 s and an elongated medical device 26 s Slave Shuttle 72 s The master shuttle 72 further includes a rotational drive mechanism (not shown) configured to operate to rotate the master shuttle 72 about its longitudinal axis relative to the master shuttle 72. m and Slave Shuttle 72 s Each of the master shuttles 72 may include a manual actuator (not shown) configured to operate the rotational drive mechanism. m and Slave Shuttle 72 s One or both of the elongated medical instruments 26 m , 26 s axial compression applied to each of the elongated medical devices 26 m , 26 s Each of the ribs 144 may include an anti-buckling mechanism (not shown) configured to prevent the ribs 144 from escaping.

[0252] In much the same manner as described above with respect to the intravascular management and tracking systems 14', 14" described above, the master shuttle 72 m Manual actuator 102 m When the master shuttle 72 is rotated about its axis of rotation 504a in either a clockwise or counterclockwise direction 502a, m Axial drive mechanism 92 m 7, the master shuttle 72 is driven along the track 70-1 in either a proximal direction 150a or a distal direction 150b. m axially translates the slave shuttle 72 s Optional manual actuator 102 m When the axial drive mechanism 92 is rotated in either a clockwise or counterclockwise direction 502b about its rotation axis 504b, s 7, the slave shuttle 72 is driven in either a proximal direction 150a or a distal direction 150b along a track 70-1 via the s is translated in the axial direction.

[0253] However, along track 70-1, master shuttle 72 m In addition to axially translating the master shuttle 72 m Manual actuator 102 m about its axis of rotation 504a to move slave shuttle 72 along track 70-1 according to a positive or negative axial translation ratio, as described above with respect to FIG. s 150a or 150b. s Axial drive mechanism 92 s Optional manual actuator 102 s Slave Shuttle 72 s If provided in the shuttle 72 s acts as the master shuttle, and shuttle 72 m Shuttle 72 acts as the slave shuttle. m , 72 sIn this case, the Shuttle 72 function can be switched. s In addition to axially translating the shuttle 72 along the track 70-1, s Optional manual actuator 102 s When the shuttle 72 is rotated along its axis of rotation 504b, the shuttle 72 is rotated via the mechanical controller 500b. m Axial drive mechanism 92 m also operates to move the shuttle 72 according to a positive or negative axial translation ratio. m is translated axially along track 70-1 in either a proximal direction 150a or a distal direction 150b.

[0254] For this reason, the mechanical controller 500b controls the master and slave shuttles 72 m , 72 s Each of the axial drive mechanisms 92 m , 92 s The control shaft 500b is in the form of a control shaft mechanically coupled between the master shuttle 72. m Axial drive mechanism 92 m The slave shuttle 72 is configured to rotate (indicated by double-headed arrow 506) about its longitudinal axis 508 in response to actuation of the s Axial drive mechanism 92 s are configured to operate in response to rotation of the control shaft 500b about its longitudinal axis 508. As a result, the master and slave shuttles 72 m , 72 s translate axially along track 70-1 synchronously according to a positive or negative axial translation ratio.

[0255] As will be described in more detail below, the control shaft 500b is connected to an axial drive mechanism 92. m , 92 s 5, mechanically coupled between the control shaft 500b and the master and slave shuttles 72. m , 72 s while the control shaft 500b and the master and slave shuttles 72 are configured to translate axially simultaneously. m, 72 s In the illustrated embodiment, the control shaft 500b and the master shuttle 72 are configured to translate axially relative to each other. m are configured to translate axially together, and the control shaft 500b and the slave shuttle 72 sは The actuators are configured for axial translation relative to one another.

[0256] As will be described in more detail below, the control shaft 500b is connected to the master and slave shuttles 72. m , 72 s Axial drive mechanism 92 m , 92 s The slave shuttle 72 along the track 70-1 is removably mechanically coupled between the slave shuttle 72 and the intravascular management and tracking system 14-1, so that the intravascular management and tracking system 14-1 can be switched between a master-slave configuration. s The axial translation of the master shuttle 72 m Manual actuator 102 m In response to the operation of the master shuttle 72 along the track 70-1, m and a master and slave shuttle 72. m ,72 s Manual actuator 102 m , 102 s In response to the operation of the master and slave shuttles 72 m , 72 sの The axial translations can be switched between synchronized and independent configurations.

[0257] As mentioned above, the master shuttle 72 m Axial drive mechanism 92 m Master Shuttle 72 m Manual actuator 102 m 502a. Thus, the manual actuator 102 m The rotation of the axial drive mechanism 92 m This activates the master shuttle 72. maxially translates along track 70-1 while rotating control shaft 500b about its longitudinal axis 508, thereby driving axial drive mechanism 92. s This activates slave shuttle 72. s axially translates along track 70-1. s Slave Shuttle 72 m If provided in the axial drive mechanism 92 s The operation of the slave shuttle 72 along the track 70-1 s As an auxiliary function for the axial translation of the s may be rotated in either a clockwise or counterclockwise direction 502b.

[0258] As will be described in more detail below, each master and slave shuttle 72 m , 72 s Axial drive mechanism 92 m , 92 s The master and slave shuttle 72 m , 72 s The master shuttle 72 can be designed to provide a particular axial translation ratio (positive or negative) between the master shuttle 72 and the m Manual actuator 102 m When the master shuttle 72 is selectively rotated in either a clockwise or counterclockwise direction 502a, m In addition to selectively axially translating in one of the proximal and distal directions 150a and 150b, the control shaft 500b selectively rotates about its longitudinal axis 508 in one of two rotational directions 506, thereby rotating the slave shuttle 72. m is selectively axially translated in one of a proximal direction 150a and a distal direction 150b.

[0259] In the illustrated embodiment, the axial drive mechanism 92 m , 92 s are the master and slave shuttles 72 m , 72 s Manual actuator 102m , 102 s , control shaft 500b, and track 70-1, and master and slave shuttles 72 m , 72 s The worm drive 510 and pinion gear 512 provide the aforementioned synchronized axial movement of the worm shaft 510 and pinion gear 512.

[0260] In particular, the pinion gear 512 is connected to the master and slave shuttles 72 m , 72 s Manual actuator 102 m , 102 s and teeth 84-1 of track 70-1 to move master and slave shuttles 72 along track 70-1. m , 72 s while the axial drive mechanism 92 m , 92 s Each of the worm drives 508 includes a worm screw 514 between which the control shaft 500b is operatively coupled and a respective manual actuator 102. m , 102 s and the worm screw 514 to move the master and slave shuttles 72 along the track 70-1. m , 72 s and a worm gear 516 for synchronizing the axial translation of the

[0261] In the illustrated embodiment, the master shuttle 72 m The pinion gear 512 is the Master Shuttle 72 m Manual actuator 102 m and the teeth 84 of the track 70-1, and a manual actuator 102 m Rotation of the master shuttle 72 in either a clockwise or counterclockwise direction 502a about its axis of rotation 504a causes the master shuttle 72 m This rotates pinion gear 512, which engages teeth 84-1 of track 70-1 to rotate master shuttle 72. maxially translates the slave shuttle 72 in either the proximal direction 150a or the distal direction 150b along the track 70-1. s Pinion gear 512 is slave shuttle 72 s Optional manual actuator 102 s and the teeth 84 of the track 70-1, and the slave shuttle 72 s Optional manual actuator 102 s When the slave shuttle 72 rotates about its axis of rotation 504b in either the clockwise or counterclockwise direction 502b, s pinion gear 512 rotates, which engages teeth 84-1 of track 70-1, causing slave shuttle 72 s The pinion gear 512 axially translates the master and slave shuttles 72 in either the proximal direction 150a or the distal direction 150b along the track 70-1. m , 72 s Manual actuator 102 m , 102 s Although shown as being directly coupled to the master and slave shuttles 72, the pinion gears 512 may be coupled to the master and slave shuttles 72 via a shaft (not shown) or another gear mechanism (not shown). m , 72 s Manual actuator 102 m , 102 s It should be understood that the present invention may be indirectly coupled to

[0262] Master Shuttle 72 m The worm gear 516 is connected to the manual actuator 102 m and Master Shuttle 72 m The manual actuator 102 is mechanically coupled to the worm screw 514 of the m 5 rotates about its axis of rotation 504a in either a clockwise or counterclockwise direction 502a, causing the worm gear 516 to rotate, which in turn rotates the master shuttle 72 m The worm screw 514 rotates.

[0263] Axial drive mechanism 92m , 92 s Each of the worm screws 514 has a bore 518 (shown in FIG. 59) through which the control shaft 500b is inserted. The bore 518 of the worm screw 514 and the outer periphery of the control shaft 500b are keyed together, so that the worm screw 514 and the control shaft 500b rotate together. m Rotation of the worm screw 514 rotates the control shaft 500b, which in turn rotates the slave shuttle 72. s 59, the cross section of the bore 518 and the outer periphery of the control shaft 500b may be cruciform. Of course, matching cross-sectional shapes other than circular may be used to key the bore 518 of the worm screw 514 and the outer periphery of the control shaft 500b.

[0264] Slave Shuttle 72 s The worm gear 516 can be used with the optional manual actuator 102 s and Slave Shuttle 72 s The slave shuttle 72 is mechanically coupled to the worm screw 514 such that rotation of the worm screw 514 rotates the worm gear 516 which in turn rotates the slave shuttle 72. s Optional manual actuator 102 s is rotated in either a clockwise direction 502b or a counterclockwise direction 502b about its axis of rotation 504b, which rotates the slave shuttle 72 s 70-1, which in turn engages teeth 84-1 of track 70-1, rotating slave shuttle 72. s The slave shuttle 72 is axially translated along the track 70-1 in either the proximal direction 150a or the distal direction 150b. s Manual actuator 102 s If no slave shuttle 72 is installed, s The worm gear 516 is the slave shuttle 72 sThe slave shuttle 72 is mechanically coupled between the worm screw 514 and the pinion gear 516 such that rotation of the worm screw 514 rotates the worm gear 516 which in turn rotates the slave shuttle 72. s 1, which rotates the pinion gear 512 of the slave shuttle 72, which engages the teeth 84-1 of the track 70-1. s is translated axially along track 70-1 in either a proximal direction 150a or a distal direction 150b.

[0265] Shuttle 72 m , 72 s When the function is switched, the shuttle 72 s acts as the master shuttle, and shuttle 72 m acts as a slave shuttle, and manual actuator 102 s Shuttle 72 operated by s can translate axially along the track 70-1. In particular, the manual actuator 102 s When the shuttle 72 rotates about its axis of rotation 504b in either a clockwise or counterclockwise direction 502b, s The worm gear 516 rotates, which drives the shuttle 72. s This rotates the worm screw 514, which rotates the control shaft 500b, which in turn rotates the shuttle 72. m This rotates the worm screw 514, which rotates the shuttle 72. m This rotates the worm gear 516 of the shuttle 72. m Manual actuator 102 m rotates about its axis of rotation 504a in either a clockwise or counterclockwise direction 502a, thereby rotating the shuttle 72 m The pinion gear 512 rotates, which causes the shuttle 72 m engages teeth 84-1 of track 70-1, causing shuttle 72 m is translated axially along track 70-1 in either a proximal direction 150a or a distal direction 150b.

[0266] As described above, the control shaft 500b and the master shuttle 72 m are configured to translate axially together, and the control shaft 500b and the slave shuttle 72 s As briefly described above, the control shaft 500b controls the first and second axial drive mechanisms 92 such that the endovascular management and tracking system 14-1 can be switched between a master-slave configuration and an independent configuration. m , 92 s In this case, the worm screw 514 may be mechanically coupled in a removable manner between the master shuttle 72 and the control shaft 500b. In the illustrated embodiment, one end of the control shaft 500b is connected to the master shuttle 72. m 514 and slides within the bore 518 of the worm screw 514 to engage the master shuttle 72 via a friction fit. m 520, so that the control shaft 500b is secured to the master shuttle 72. m 4, while the other end of control shaft 500b is prevented from axial translation relative to slave shuttle 72. s worm screw 514, which slides within bore 518 of worm screw 514, thereby causing control shaft 500b to move slave shuttle 72 s The control shaft 500b is adapted to be axially translated relative to the master shuttle 72. m and Slave Shuttle 72 s To remove it from the master shuttle 72, one end of the control shaft 500b is removed from the bushing 520 and the master shuttle 72 is removed. m while sliding the other end of the control shaft 500b out of the bore 518 of the worm screw 514. s It can simply be slid out of the bore 518 of the worm screw 514.

[0267] As briefly mentioned above, each master and slave shuttle 72 m , 72 s Axial drive mechanism 92 m , 92 s The master and slave shuttle 72 m , 72 sFor example, the master and slave shuttles 72 may be designed to provide a particular axial translation ratio (positive or negative) between them. m , 72 s The worm screw 514 has an axial translation ratio of 1 (master and slave shuttle 72 m , 72 s The master and slave shuttles 72 may have the same pitch, such that each translates the track 70-1 axially the same distance, or the axial translation ratio may be greater than or less than 1 (master and slave shuttles 72 m , 72 s may have different pitches such that the master and slave shuttles 72 axially translate the track 70-1 by different distances. m , 72 s The worm screw 514 has a positive axial translation ratio (master and slave shuttle 72 m , 72 s The master and slave shuttles 72 and 73 may have the same directional pitch, such that both axially translate the trucks 70-1 and 70-2 in the same direction, or the axial translation ratio may be negative (master and slave shuttles 72 and 73 may have the same directional pitch, such that both axially translate the trucks 70-1 and 70-2 in the same direction). m , 72 s In one embodiment, the worm drive 508 is coupled to the master shuttle 72. m and Slave Shuttle 72 s The worm drive 508 having a different pitch for the worm screw 514 is removably disposed in either or both of the master shuttle 72. m and / or Slave Shuttle 72 s Put it in and take it out, Master Shuttle 72 m and Slave Shuttle 72 s The synchronized axial translation of the master shuttle 72 can be customized for the particular medical procedure being performed (i.e., m and Slave Shuttle 72 s (One can choose different relative axial translations between

[0268] Synchronization of elongated medical instruments using the intravascular management and tracking system 14-1 shown in FIG. 56 (using either an electrical or mechanical controller) is suitable for medical procedures requiring simultaneous translation of coaxial medical instruments relative to one another. For example, in a stent deployment procedure, one of the elongated medical instruments may be a stent deployment catheter and the other of the elongated medical instruments may be a pusher member attached to a stent within the stent deployment catheter. When deploying a stent from the stent deployment catheter, it is desirable to move the pusher member distally while retracting the stent deployment catheter proximally, thereby ejecting the stent from the stent deployment catheter.

[0269] As applied to the intravascular management and tracking system 14-1 shown in FIG. 60A, the master shuttle 72 m An elongated medical instrument 26 attached to (in this case, the distal shuttle or the trailing shuttle) m is a stent deployment catheter, while slave shuttle 72 s An elongated medical instrument 26 attached to (in this case, the proximal shuttle or leading shuttle) s 550 may be a pusher member having a stent 550 attached thereto. Thus, as shown in FIG. 60B, the stent deployment catheter 26 m in the proximal direction 150a. m In response to manually moving the pusher member 26 in the proximal direction 150a along the track 70-1, the controller 500 m In order to advance the slave shuttle 72 in a distal direction, sを axially translate along track 70-1 in distal direction 150b (i.e., with a negative axial translation ratio, e.g., 1), such that stent 550 is deployed by stent deployment catheter 26 m 60C, the stent 550 may be deployed back if the deployment of the stent 550 is not optimal. min the distal direction 150b. m In response to manually translating the pusher member 26 in the distal direction 150b along the track 70-1, the controller 500 m In order to retract the slave shuttle 72 in the proximal direction, s axially move the stent 550 in the proximal direction 150a along the track 70-1 (i.e., with a negative axial translation ratio, e.g., 1), thereby moving the partially deployed stent 550 toward the stent deployment catheter 26. m The distal end of the catheter is then recoated.

[0270] In an alternative embodiment shown in FIG. m is instead the leading shuttle, in which case slave shuttle 72 s Long, thin medical instruments that can be attached to 26 s serves as a pusher member to which the stent 550 is attached, and the slave shuttle 72 s is the trailing shuttle, in which case the master shuttle 72 m Long, thin medical instruments that can be attached to 26 m In this case, the master shuttle 72 is a stent deployment catheter. m 70-1 in the distal direction 150b to move the pusher member 26 m In response to advancing the stent deployment catheter 26 in the distal direction 150b, the controller 500 s In order to retract the slave shuttle 72 in the proximal direction, s axially move along track 70-1 in the proximal direction 150a (i.e., with a negative axial translation ratio, e.g., 1), thereby moving stent deployment catheter 26 m The stent 550 is deployed from the distal end of the pusher member 26 such that the stent 550 expands into contact with the inner wall of the blood vessel (not shown). m In order to retract the master shuttle 72 in the proximal direction 150a m In response to manually translating the stent deployment catheter 26 in the proximal direction 150a along the track 70-1, the controller 500s In order to advance the slave shuttle 72 in a distal direction, sを axially translate along track 70-1 in distal direction 150b (i.e., with a negative axial translation ratio, e.g., 1) so that partially deployed stent 550 is deployed by stent deployment catheter 26 s The distal end of the catheter is then recoated.

[0271] In another embodiment, the master shuttle 72 along the track 70-1 m In response to the manual translation of the slave shuttle 72 along the track 70-1, the controller 500 s The axial translation ratio that automatically translates the stent 550 may vary depending on, for example, one or more conditions. In this case, the controller 500 may be motorized to dynamically vary the axial translation ratio. In one embodiment shown in FIG. 60E, the endovascular management and tracking system 14-1 further includes a medical imaging device (e.g., a fluoroscopic imaging device) 552 configured to image the stent 550 and provide the image to the controller 500. In this regard, the stent 550 may comprise a radiopaque element. The controller 500 may be configured to identify the deployment stage of the stent 550 (e.g., whether the stent 550 has reached its intended deployment diameter) based on the image acquired by the medical imaging device 552. As described above with respect to FIG. 60B (alternatively, FIG. 60D), the master shuttle 72 m As the stent 550 is deployed from the stent deployment catheter in response to manual translation of the stent, the controller 500 dynamically varies the axial translation ratio to ensure optimal apposition of the stent with the vessel wall.

[0272] As another example of a medical procedure suitable for the intravascular management and tracking system 14-1 shown in Figure 56, one of the elongated medical instruments may be a guidewire and the other of the elongated medical instruments may be a catheter. When navigating the guidewire through the vasculature of the patient 20, it is desirable for the catheter to follow the guidewire at a preset setback distance from the tip of the guidewire.

[0273] As applied to the intravascular management and tracking system 14-1 shown in FIG. 61A, the master shuttle 72 m An elongated medical instrument 26 attached to (in this case, the lead shuttle) m is the guide wire, and the slave shuttle 72 s An elongated medical instrument 26 attached to (in this case, the trailing shuttle) s The guidewire 26 may be a catheter. m in the distal direction 150b. m In response to manually translating catheter 26 in distal direction 150b along track 70-1, controller 500 s In order to advance the slave shuttle 72 in a distal direction, s axially translates along track 70-1 in distal direction 150b (i.e., with a positive axial translation ratio, e.g., 1), thereby causing guidewire 26 m At a predetermined offset distance d from the tip of the guidewire 26 m As shown in FIG. 61C, the elongated medical instrument 26 m (Here, catheter 26 m ) in the proximal direction 150a, m (here, the trailing shuttle) is manually translated in the proximal direction 150a along track 70-1 to move the trailing shuttle to slave shuttle 72. s From Master Shuttle 72 m In response, the controller 500 switches the slave shuttle 72 s axially translating the guidewire 26 (here, the lead shuttle) in the proximal direction 150a along track 70-1 s proximally (i.e., with a positive axial translation ratio, e.g., 1), thereby causing catheter 26 m Guidewire for 26 s (i.e., a predetermined offset distance d) is maintained.

[0274] As yet another example of a medical procedure suitable for the endovascular management and tracking system 14-1 shown in Figure 56, one of the elongated medical instruments may be a stent reversal and the other of the elongated medical instruments may be a catheter. Upon retraction of the stent reversal after thrombus capture, it is desirable for the catheter to automatically retract when a predetermined offset distance between the stent reversal and the catheter is reached, and for the stent reversal to maintain this predetermined offset distance between the stent reversal and the catheter as it is retracted.

[0275] As applied to the intravascular management and tracking system 14-1 shown in FIG. 62A, the master shuttle 72 m An elongated medical instrument 26 attached to (in this case, the lead shuttle) m is Stent River, Slave Shuttle 72 s An elongated medical instrument 26 attached to (in this case, the trailing shuttle) s The catheter may be a catheter. Thus, the stent river 26 with the captured thrombus 554 m In order to retract the master shuttle 72 in the proximal direction 150a, m In response to manually translating the slave shuttle 72 in the proximal direction 150a along track 70-1, the controller 500 moves the slave shuttle 72 along track 70-1, as shown in FIG. 62B, until a predetermined offset distance d between the stent lever and the catheter is achieved. s The stent river 26 is then moved axially along with the captured thrombus 554. m In order to further retract the master shuttle 72 in the proximal direction 150a, m In response to further manual translation of catheter 26 in proximal direction 150a along track 70-1, controller 500 s In order to retract the slave shuttle 72 in the proximal direction, s axially translates along track 70-1 in the proximal direction 150a (i.e., with a positive axial translation ratio, e.g., 1), thereby forming stent river 26 as shown in FIG. 62C. m During proximal retraction of the stent, a predetermined offset distance d between the stent lever and the catheter is maintained.

[0276] While the endovascular management and tracking systems 14, 14' previously described have been described as having flexible tracks 70, 70' that contour to a hospital room environment, for example, overlaid on the procedure table 18, patient 20, and / or drape 22, in one embodiment of the endovascular management and tracking system 14", the track 70" is suspended above the procedure table 18", as shown in Figures 63-65.

[0277] In particular, similar to endovascular management and tracking systems 14, 14', endovascular management and tracking system 14" includes a track 70" and a plurality of shuttles 72a"-72c" mechanically coupled to track 70" and configured to translate axially along track 70". Each shuttle 72a"-72c" may be configured similarly to shuttles 72a"-72c" illustrated in FIG. 6 or shuttle 72' illustrated in FIGS. 21-24, for example. Shuttles 72a"-72c" may also include an anti-buckling mechanism 132" configured to respectively prevent a respective elongate medical device (not shown) from prolapse in response to axial compression applied to the respective elongate medical device.

[0278] However, the endovascular management and tracking system 14" further includes a plurality of track support arms 530. One end 532 of each of the track support arms 530 is configured to be secured to the procedure table 18" and the other end 534 of each of the track support arms 530 is configured to be removably secured (e.g., via a clamping mechanism 536) to the track 70" such that the track 70" may be suspended above the procedure table 18". The ends 532 of the track support arms 530 may be permanently or removably secured to the procedure table 18". As best shown in FIG. 65, the endovascular management and tracking system 14" further includes a plurality of legs 532 attached to the other ends 534 of the track support arms 530, with the track 70" configured to be mounted on the legs 538. In any embodiment, the bottom surface of the track 70" has a channel (not shown) along the length of the track 70", and each of the legs 538 includes a cleat (not shown) configured to be removably attached to the channel of the track 70".

[0279] The track support arm 530 is preferably rigid so that the track 70" is stably suspended above the treatment table 18" as the shuttles 72a"-72c" translate axially along the track 70". In a preferred embodiment, the track support arm 530 may be configured to be adjusted relative to the treatment table 18" so that the height of the other end 534 of the track support arm 530 relative to the treatment table 18" can be selected, and / or the legs 538 may be configured to be adjusted relative to the other end 534 of the track support arm 530 so that the height of the legs 538 relative to the treatment table 18" can be selected. In this manner, the contour of the track 70" in free space can be altered or customized. In the illustrated embodiment, the track 70" is contoured to form an arch that facilitates supporting the shuttles 72a"-72c" against gravity.

[0280] While particular embodiments of the present invention have been shown and described, it is not intended to limit the invention to the preferred embodiments, and it will be understood that it will be apparent to those skilled in the art that various changes and modifications may be made thereto without departing from the spirit and scope of the present invention. Accordingly, the present invention is intended to cover alternatives, modifications, and equivalents which may be included within the spirit and scope of the present invention as defined by the claims.

Claims

1. An intravascular management and tracking system, comprising: a track; and at least one shuttle to which at least one elongated medical device is respectively attached, each of the at least one shuttle being configured to be mechanically detachably coupled to the track, a thread configured to ride on the track, an axial drive mechanism configured to be actuated to axially translate each shuttle along the track and carried by the thread, and a first actuator carried by the thread and configured to actuate the axial drive mechanism. An intravascular management and tracking system characterized by that.

2. The intravascular management and tracking system according to claim 1, wherein the track is flexible.

3. The intravascular management and tracking system according to claim 1, wherein each of the at least one elongated medical device is one of a guide sheath, a working catheter, and a guide wire.

4. The intravascular management and tracking system according to claim 1, wherein the at least one shuttle consists of a plurality of shuttles, and the at least one elongated medical device consists of a plurality of elongated medical devices.

5. The intravascular management and tracking system according to claim 4, wherein each of the plurality of shuttles includes a clutch mechanism configured to alternately engage the axial drive mechanism with the track and disengage the axial drive mechanism from the track.

6. The intravascular management and tracking system according to claim 4, wherein each of the plurality of shuttles is configured to be screwed onto the track.

7. The intravascular management and tracking system according to claim 4, wherein each of the plurality of shuttles is configured to fit laterally onto the track.

8. Each subsequent one of the plurality of shuttles is configured to slidably receive the distal end of each of the plurality of elongated medical devices attached to a preceding one of the plurality of shuttles, and each elongated medical device attached to the preceding shuttle is coaxially disposed within one of each of the plurality of elongated medical devices attached to the subsequent shuttle. The intravascular management and tracking system according to claim 4.

9. One of the plurality of shuttles is a master shuttle, and another one of the plurality of shuttles is a slave shuttle. The intravascular management and tracking system further includes a controller configured to operate the axial drive mechanism of the slave shuttle in response to the operation of the axial drive mechanism of the master shuttle. The slave shuttle is configured to axially translate along the track in synchronization with the axial translation of the master shuttle along the track. The intravascular management and tracking system according to claim 4.

10. The intravascular management and tracking system according to claim 9, wherein the controller is an electrical controller.

11. The intravascular management and tracking system according to claim 9, wherein the controller is a mechanical controller.

12. Each of the at least one shuttle further includes an on-board fluid management control assembly configured to be carried by the thread and fluidly coupled to an elongate medical device attached to each shuttle. The intravascular management and tracking system according to claim 1.

13. The intravascular management and tracking system according to claim 12, wherein the on-board fluid management control assembly includes a rotary hemostatic valve (RHV).

14. The intravascular management and tracking system according to claim 13, wherein the RHV is configured to be removable from each respective shuttle.

15. Each of the at least one shuttle includes a rotary drive mechanism configured to be carried by the thread and operated to rotate a respective elongate medical device about its longitudinal axis, and a second actuator configured to be carried by the thread and operate the rotary drive mechanism. The intravascular management and tracking system according to claim 1.

16. The intravascular management and tracking system according to claim 1, further including a locking mechanism configured to be carried by the thread and manually operated to alternately engage and disengage the axial drive mechanism with the track.

17. Each of the at least one elongated medical instrument is flexible, and the intravascular management and tracking system according to claim 1 further comprises an anti-buckling mechanism configured such that one or more of the at least one shuttle prevent the respective elongated medical instrument from escaping in response to axial compression applied to the respective elongated medical instrument.

18. The intravascular management and tracking system according to claim 17, wherein each of the one or more anti-buckling mechanisms comprises a tubular member configured such that the respective elongated medical instrument is slidably disposed therein.

19. The intravascular management and tracking system according to claim 18, wherein the tubular member has a slit extending along the length of the tubular member.

20. The distal end of each of the one or more anti-buckling mechanisms is configured to be attached at a position, and each anti-buckling mechanism is configured to elongate when the respective shuttle is axially translated away from the position and to shorten when the respective shuttle is axially translated toward the position. The intravascular management and tracking system according to claim 17.

21. The intravascular management and tracking system according to claim 20, wherein the position at which the distal end of one of the one or more anti-buckling mechanisms is attached is a position fixed relative to the patient.

22. The intravascular management and tracking system according to claim 20, wherein the at least one shuttle comprises a plurality of shuttles, and the position at which the distal end of a leading one of the plurality of shuttles is attached to an anti-buckling mechanism is a subsequent one of the plurality of shuttles.

23. The intravascular management and tracking system according to claim 17, wherein the anti-buckling mechanism includes the axial drive mechanism.

24. The intravascular management and tracking system according to claim 1, wherein the first actuator is a manual actuator.

25. The intravascular management and tracking system according to claim 1, wherein the first actuator is a motor.

26. A robotic intravascular system, comprising the intravascular management and tracking system according to claim 25, and a master input device configured to receive manual commands from a user and transmit control signals to the motors of each of the at least one shuttle.

27. The robotic intravascular system of claim 26, wherein each of said at least one shuttle comprises a manual actuator configured to operate said axial drive mechanism.

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