Patent Description:
Vascular disease, and in particular cardiovascular disease, may be treated in a variety of ways. Surgery, such as cardiac bypass surgery, is one method for treating cardiovascular disease. However, under certain circumstances, vascular disease may be treated with a catheter based intervention procedure, such as angioplasty. Catheter based intervention procedures are generally considered less invasive than surgery. If a patient shows symptoms indicative of cardiovascular disease, an image of the patient's heart may be taken to aid in the diagnosis of the patient's disease and to determine an appropriate course of treatment. For certain disease types, such as atherosclerosis, the image of the patient's heart may show a lesion that is blocking one or more coronary arteries. Following the diagnostic procedure, the patient may undergo a catheter based intervention procedure. During one type of intervention procedure, a catheter is inserted into the patient's femoral artery and moved through the patient's arterial system until the catheter reaches the site of the lesion. In some procedures, the catheter is equipped with a balloon or a stent that when deployed at the site of a lesion allows for increased blood flow through the portion of the coronary artery that is affected by the lesion. In addition to cardiovascular disease, other diseases (e.g., hypertension, etc.) may be treated using catheterization procedures. <CIT> describes a robotic catheter system including one or more robotic catheter manipulator assemblies supported on a manipulator support structure. The robotic catheter manipulator assembly may include one or more removably mounted robotic catheter device cartridges and robotic sheath device cartridges, with each cartridge being generally linearly movable relative to the robotic catheter manipulator assembly. An input control system may be provided for controlling operation of the robotic catheter manipulator assembly. A visualization system may include one or more display monitors for displaying a position of a catheter and/or a sheath respectively attached to the robotic catheter and sheath device cartridges. <CIT> describes a catheter drive cassette configured to be removably coupled to a motor drive base. The cassette comprises a first axial drive mechanism configured to drive a guide wire along its longitudinal axis; a second axial drive mechanism configured to drive a working catheter along its longitudinal axis; and a first rotational drive mechanism configured to rotate the guide wire about its longitudinal axis. <CIT> describes a method of operating a navigation system that can orient the distal end of a medical device in a selected direction to navigate the medical device through a network of body lumens in an operating region in a subject. The method includes identifying a path through the network of body lumens in the operating region; displaying a two-dimensional image of the operating region including the path through the body lumens; determining at least one location on the path; and operating the navigation system to orient the distal end of the medical device in a direction substantially aligned with the path at the at least one location and advancing the distal end of the medical device. <CIT> describes a linear medical insertion device able to be manipulated by a single physician. An insertion device for inserting a delivery wire into a blood vessel of a human includes foot switches for issuing a signal for controlling the stop/start of a drive device that moves the delivery wire in the longitudinal axis direction. The insertion device additionally includes an insertion force sensor for measuring the compressive force acting on the delivery wire in the longitudinal axis direction, and a speaker and display unit for communicating the compressive force measured by the insertion force sensor to the practitioner.

According to the invention a robotic catheter procedure system is set out in claim <NUM>.

Alternative exemplary embodiments relate to other features and combinations of features as may be generally recited in the claims.

This application will become more fully understood from the following detailed description, taken in conjunction with the accompanying figures, wherein like reference numerals refer to like elements in which:.

Referring to <FIG>, a catheter procedure system <NUM> is shown. Catheter procedure system <NUM> may be used to perform catheter based medical procedures (e.g., percutaneous intervention procedures). Percutaneous intervention procedures may include diagnostic catheterization procedures during which one or more catheters are used to aid in the diagnosis of a patient's disease. For example, during one embodiment of a catheter based diagnostic procedure, a contrast media is injected into one or more coronary arteries through a catheter and an image of the patient's heart is taken. Percutaneous intervention
procedures may also include catheter based therapeutic procedures (e.g., balloon angioplasty, stent placement, treatment of peripheral vascular disease, etc.) during which a catheter is used to treat a disease. It should be noted, however, that one skilled in the art would recognize that, certain specific percutaneous intervention devices or components (e.g., type of guide wire, type of catheter, etc.) will be selected based on the type of procedure that is to be performed. Catheter procedure system <NUM> is capable of performing any number of catheter based medical procedures with minor adjustments to accommodate the specific percutaneous devices to be used in the procedure. In particular, while the embodiments of catheter procedure system <NUM> described herein are explained primarily in relation to the diagnosis and/or treatment of coronary disease, catheter procedure system <NUM> may be used to diagnose and/or treat any type of disease or condition amenable to diagnosis and/or treatment via a catheter based procedure.

Catheter procedure system <NUM> includes lab unit <NUM> and workstation <NUM>. Catheter procedure system <NUM> includes a robotic catheter system, shown as bedside system <NUM>, located within lab unit <NUM> adjacent patient <NUM>. Generally, bedside system <NUM> may be equipped with the appropriate percutaneous devices (e.g., guide wires, guide catheters, working catheters, catheter balloons, stents, diagnostic catheters, etc.) or other components (e.g., contrast media, medicine, etc.) to allow the user to perform a catheter based medical procedure. A robotic catheter system, such as bedside system <NUM>, may be any system configured to allow a user to perform a catheter-based medical procedure via a robotic system by operating various controls such as the controls located at workstation <NUM>. Bedside system <NUM> may include any number and/or combination of components to provide bedside system <NUM> with the functionality described herein. Various embodiments of bedside system <NUM> are described in detail in P. International Application No. <CIT>.

In one embodiment, bedside system <NUM> may be equipped to perform a catheter based diagnostic procedure, and in another embodiment, bedside system <NUM> may be equipped to perform a catheter based therapeutic procedure. Bedside system <NUM> may be equipped with one or more of a variety of catheters for the delivery of contrast media to the coronary arteries. In one embodiment, bedside system <NUM> may be equipped with a first catheter shaped to deliver contrast media to the coronary arteries on the left side of the heart, a second catheter shaped to deliver contrast media to the coronary arteries on the right side of the heart, and a third catheter shaped to deliver contrast media into the chambers of the heart. In other embodiments, bedside system <NUM> may be equipped with a guide catheter, a guide wire, and a working catheter (e.g., a balloon catheter, a stent delivery catheter, ablation catheter, etc.). In one embodiment, bedside system <NUM> may equipped with a working catheter that includes a secondary lumen that is threaded over the guide wire during a procedure. In another embodiment, bedside system <NUM> may be equipped with an over-the-wire working catheter that includes a central lumen that is threaded over the guide wire during a procedure. In another embodiment, bedside system <NUM> may be equipped with an intravascular ultrasound (IVUS) catheter. In another embodiment, any of the percutaneous devices of bedside system <NUM> may be equipped with positional sensors that indicate the position of the component within the body.

Bedside system <NUM> is in communication with workstation <NUM>, allowing signals generated by the user inputs and control system of workstation <NUM> to be transmitted to bedside system <NUM> to control the various functions of beside system <NUM>. Bedside system <NUM> also may provide feedback signals (e.g., operating conditions, warning signals, error codes, etc.) to workstation <NUM>. Bedside system <NUM> may be connected to workstation <NUM> via a communication link <NUM> that may be a wireless connection, cable connectors, or any other means capable of allowing communication to occur between workstation <NUM> and beside system <NUM>.

Workstation <NUM> includes a user interface <NUM>. User interface <NUM> includes controls <NUM>. Controls <NUM> allow the user to control bedside system <NUM> to perform a catheter based medical procedure. For example, controls <NUM> may be configured to cause bedside system <NUM> to perform various tasks using the various percutaneous devices with which bedside system <NUM> may be equipped (e.g., to advance, retract, or rotate a guide wire, advance, retract, or rotate a working catheter, advance, retract, or rotate a guide catheter, inflate or deflate a balloon located on a catheter, position and/or deploy a stent, inject contrast media into a catheter, inject medicine into a catheter, or to perform any other function that may be performed as part of a catheter based medical procedure, etc.).

In one embodiment, controls <NUM> include a touch screen <NUM>, a dedicated guide catheter control <NUM>, a dedicated guide wire control <NUM>, and a dedicated working catheter control <NUM>. In this embodiment, guide wire control <NUM> is a joystick configured to cause bedside system <NUM> to advance, retract, or rotate a guide wire, working catheter control <NUM> is a joystick configured to cause bedside system <NUM> to advance, refract, or rotate a working catheter, and guide catheter control <NUM> is a joystick configured to cause bedside system <NUM> to advance, retract, or rotate a guide catheter. In addition, touch screen <NUM> may display one or more icons (such as icons <NUM>, <NUM>, and <NUM>) that control movement of one or more percutaneous devices via bedside system <NUM>. Controls <NUM> may also include a balloon or stent control that is configured to inflate or deflate a balloon and/or a stent. Each of the controls may include one or more buttons, joysticks, touch screens, etc., that may be desirable to control the particular component to which the control is dedicated.

Controls <NUM> may include an emergency stop button <NUM> and a multiplier button <NUM>. When emergency stop button <NUM> is pushed a relay is triggered to cut the power supply to bedside system <NUM>. Multiplier button <NUM> acts to increase or decrease the speed at which the associated component is moved in response to a manipulation of guide catheter control <NUM>, guide wire control <NUM>, and working catheter control <NUM>. For example, if operation of guide wire control <NUM> advances the guide wire at a rate of <NUM>/sec, pushing multiplier button <NUM> may cause operation of guide wire control <NUM> to advance the guide wire at a rate of <NUM>/sec. Multiplier button <NUM> may be a toggle allowing the multiplier effect to be toggled on and off. In another embodiment, multiplier button <NUM> must be held down by the user to increase the speed of a component during operation of controls <NUM>.

User interface <NUM> may include a first monitor <NUM> and a second monitor <NUM>. First monitor <NUM> and second monitor <NUM> may be configured to display information or patient specific data to the user located at workstation <NUM>. For example, first monitor <NUM> and second monitor <NUM> may be configured to display image data (e.g., x-ray images, MRI images, CT images, ultrasound images, etc.), hemodynamic data (e.g., blood pressure, heart rate, etc.), patient record information (e.g., medical history, age, weight, etc.). In addition, first monitor <NUM> and second monitor <NUM> may be configured to display procedure specific information (e.g., duration of procedure, catheter or guide wire position, volume of medicine or contrast agent delivered, etc.). Monitor <NUM> and monitor <NUM> may be configured to display information regarding the position and/or bend of the distal tip of a steerable guide catheter. Further, monitor <NUM> and monitor <NUM> may be configured to display information to provide the functionalities associated with the various modules of controller <NUM> discussed below. In another embodiment, user interface <NUM> includes a single screen of sufficient size to display one or more of the display components and/or touch screen components discussed herein.

Catheter procedure system <NUM> also includes an imaging system <NUM> located within lab unit <NUM>. Imaging system <NUM> may be any medical imaging system that may be used in conjunction with a catheter based medical procedure (e.g., non-digital x-ray, digital x-ray, CT, MRI, ultrasound, etc.). In an exemplary embodiment, imaging system <NUM> is a digital x-ray imaging device that is in communication with workstation <NUM>. As shown in <FIG>, imaging system <NUM> may include a C-arm that allows imaging system <NUM> to partially or completely rotate around patient <NUM> in order to obtain images at different angular positions relative to patient <NUM> (e.g., sagittal views, caudal views, cranio-caudal views, etc.).

Imaging system <NUM> is configured to take x-ray images of the appropriate area of patient <NUM> during a particular procedure. For example, imaging system <NUM> may be configured to take one or more x-ray images of the heart to diagnose a heart condition. Imaging system <NUM> may also be configured to take one or more x-ray images during a catheter based medical procedure (e.g., real-time images) to assist the user of workstation <NUM> to properly position a guide wire, guide catheter, working catheter, stent, etc. during the procedure. The image or images may be displayed on first monitor <NUM> and/or second monitor <NUM>.

In addition, the user of workstation <NUM> may be able to control the angular position of imaging system <NUM> relative to the patient to obtain and display various views of the patient's heart on first monitor <NUM> and/or second monitor <NUM>. Displaying different views at different portions of the procedure may aid the user of workstation <NUM> properly move and position the percutaneous devices within the 3D geometry of the patient's heart. In an exemplary embodiment, imaging system <NUM> may be any 3D imaging modality of the past, present, or future, such as an x-ray based computed tomography (CT) imaging device, a magnetic resonance imaging device, a 3D ultrasound imaging device, etc. In this embodiment, the image of the patient's heart that is displayed during a procedure may be a 3D image. In addition, controls <NUM> may also be configured to allow the user positioned at workstation <NUM> to control various functions of imaging system <NUM> (e.g., image capture, magnification, collimation, c-arm positioning, etc.).

Referring to <FIG>, a block diagram of catheter procedure system <NUM> is shown according to an exemplary embodiment. Catheter procedure system <NUM> may include a control system, shown as controller <NUM>. As shown in <FIG>, controller <NUM> may be part of workstation <NUM>. Controller <NUM> is in communication with one or more bedside systems <NUM>, controls <NUM>, monitors <NUM> and <NUM>, imaging system <NUM>, and patient sensors <NUM> (e.g., electrocardiogram ("ECG") devices, electroencephalogram ("EEG") devices, blood pressure monitors, temperature monitors, heart rate monitors, respiratory monitors, etc.). In addition, controller <NUM> may be in communication with a hospital data management system or hospital network <NUM>, one or more additional output devices <NUM> (e.g., printer, disk drive, cd/dvd writer, etc.), and a hospital inventory management system <NUM>.

Communication between the various components of catheter procedure system <NUM> may be accomplished via communication links <NUM>. Communication links <NUM> may be dedicated wires or wireless connections. Communication links <NUM> may also represent communication over a network. Catheter procedure system <NUM> may be connected or configured to include any other systems and/or devices not explicitly shown. For example, catheter procedure system <NUM> may include IVUS systems, image processing engines, data storage and archive systems, automatic balloon and/or stent inflation systems, contrast media and/or medicine injection systems, medicine tracking and/or logging systems, user logs, encryption systems, systems to restrict access or use of catheter procedure system <NUM>, robotic catheter systems of the past, present, or future, etc..

Referring to <FIG>, an exemplary embodiment of bedside system <NUM> is shown that is configured to allow a user to advance, retract and rotate a guide wire and to advance and retract a working catheter by operating controls <NUM> located at workstation <NUM>. In the embodiment shown, bedside system <NUM> includes a cassette <NUM> and a motor drive base <NUM>. Cassette <NUM> is equipped with a guide wire <NUM> and with a working catheter <NUM> to allow a user to perform a catheterization procedure utilizing cassette <NUM>. In this embodiment, cassette <NUM> is configured to be mounted to motor drive base <NUM>. <FIG> shows a bottom perspective view of cassette <NUM> prior to mounting to motor drive base <NUM>. Motor drive base <NUM> includes a first capstan <NUM>, a second capstan <NUM>, and a third capstan <NUM>. Cassette <NUM> includes a first capstan socket <NUM>, a second capstan socket <NUM>, and a third capstan socket <NUM>. Cassette <NUM> includes a housing <NUM>, and housing <NUM> includes a base plate <NUM>.

Each of the capstan sockets is configured to receive one of the capstans of motor drive base <NUM>. In the embodiment shown, base plate <NUM> includes a hole or aperture aligned with each of the capstan sockets <NUM>, <NUM>, and <NUM> to allow each capstan to engage with the appropriate capstan socket. As discussed in more detail below, the engagement between the capstans and capstan sockets allows the transfer of energy (e.g., rotational movement) generated by one or more actuators (e.g., motors) located within motor drive base <NUM> to each of the drive mechanisms within cassette <NUM>. In one embodiment, a single actuator provides energy to each of the drive mechanisms. In another embodiment, there is an actuator that drives capstan <NUM>, an actuator that drives capstan <NUM>, and an actuator that drives capstan <NUM>. Further, the positioning of the capstans and capstan sockets helps the user to align cassette <NUM> relative to motor drive base <NUM> by allowing cassette <NUM> to be mounted to motor drive base <NUM> only when all three capstan sockets are aligned with the proper capstan.

In one embodiment, the motors that drive capstans <NUM>, <NUM>, and <NUM> are located within motor drive base <NUM>. In another embodiment, the motors that drive capstans <NUM>, <NUM>, and <NUM> may be located outside of base <NUM> connected to cassette <NUM> via an appropriate transmission device (e.g., shaft, cable, etc.). In yet another embodiment, cassette <NUM> includes motors located within the housing of cassette <NUM>. In another embodiment, cassette <NUM> does not include capstan sockets <NUM>, <NUM>, and <NUM>, but includes an alternative mechanism for transferring energy (e.g., rotational motion) from an actuator external to the cassette to each of the cassette drive mechanisms. For example, rotational movement may be transferred to the drive mechanisms of cassette <NUM> via alternating or rotating magnets or magnetic fields located within motor drive base <NUM>.

In the embodiment shown, cassette <NUM> also includes a guide catheter support <NUM> that supports guide catheter <NUM> at a position spaced from cassette <NUM>. As shown, guide catheter support <NUM> is attached to cassette <NUM> by a rod <NUM>. Rod <NUM> and guide catheter support <NUM> are strong enough to support guide catheter <NUM> without buckling. Guide catheter support <NUM> supports guide catheter <NUM> at a position spaced from the cassette, between the patient and the cassette to prevent buckling, bending, etc. of the portion of guide catheter <NUM> between the cassette and the patient.

Referring to <FIG>, cassette <NUM> is shown mounted to motor drive base <NUM>. As shown in <FIG>, cassette <NUM> includes an outer cassette cover <NUM> that may be attached to housing <NUM>. When attached to housing <NUM>, outer cassette cover <NUM> is positioned over and covers each of the drive mechanisms of cassette <NUM>. By covering the drive assemblies of cassette <NUM>, outer cassette cover <NUM> acts to prevent accidental contact with the drive mechanisms of cassette <NUM> while in use.

Referring to <FIG>, cassette <NUM> is shown in the "loading" configuration with outer cassette cover <NUM> removed. Cassette <NUM> includes a y-connector support assembly <NUM>, an axial drive assembly <NUM>, and a rotational drive assembly <NUM>. Generally, the various portions of cassette <NUM> are placed in the loading configuration to allow the user to load or install a guide wire and/or working catheter into cassette <NUM>. Cassette <NUM> includes a Y-connector <NUM> supported by y-connector support assembly <NUM>. Y-connector <NUM> includes a first leg <NUM>, a second leg <NUM>, and a third leg <NUM>. First leg <NUM> is configured to attach to a guide catheter such that the central lumen of the y-connector is in fluid communication with the central lumen of the guide catheter. Second leg <NUM> is angled away from the longitudinal axis of y-connector <NUM>. Second leg <NUM> of y-connector <NUM> allows introduction of a contrast agent or medicine into the lumen of the guide catheter. A one way valve prohibits bodily fluid from exiting second leg <NUM>. Third leg <NUM> extends away from the guide catheter toward axial drive assembly <NUM>. In use, guide wire <NUM> and working catheter <NUM> are inserted into third leg <NUM> of y-connector <NUM> via opening <NUM> and may be advanced through y-connector <NUM> into the lumen of the guide catheter. The third leg also includes a one way valve that permits insertion and removal of the working catheter and guide wire but prohibits bodily fluids from exiting third leg <NUM>.

Cassette <NUM> also includes an axial drive assembly <NUM>. Axial drive assembly <NUM> includes a first axial drive mechanism, shown as guide wire axial drive mechanism <NUM>, and a second axial drive mechanism, shown as working catheter axial drive mechanism <NUM>. Axial drive assembly <NUM> also includes a top deck <NUM> and a cover <NUM>.

Generally, in use, a guide wire, such as guide wire <NUM>, is placed within guide wire channel <NUM> formed in top deck <NUM>, and guide wire axial drive mechanism <NUM> includes an engagement structure (e. g, a structure including wheels <NUM> and <NUM> as discussed below) that is configured to releasably engage and drive (e.g., to impart motion to) guide wire <NUM> along its longitudinal axis. In this manner, guide wire axial drive mechanism <NUM> provides for advancement and/or retraction of guide wire <NUM>. In use, a working catheter, such as working catheter <NUM>, is placed within working catheter channel <NUM> formed in top deck <NUM>, and working catheter axial drive mechanism <NUM> is configured to releasably engage and drive (e.g., to impart motion to) working catheter <NUM> along its longitudinal axis. In this manner, working catheter axial drive mechanism <NUM> provides for advancement and/or retraction of working catheter <NUM>.

Cassette <NUM> also includes a rotational drive assembly <NUM>. Rotational drive assembly <NUM> includes a rotational drive mechanism, shown as guide wire rotational drive mechanism <NUM>, a cover <NUM>, and a journal <NUM>. Guide wire rotational drive mechanism <NUM> includes a chassis <NUM> and an engagement structure <NUM>. Rotational drive assembly <NUM> is configured to cause guide wire <NUM> to rotate about its longitudinal axis. Engagement structure <NUM> is configured to releasably engage guide wire <NUM> and to apply sufficient normal force to guide wire <NUM> such that guide wire <NUM> is allowed to rotate about its longitudinal axis while permitting guide wire <NUM> to be moved axially by guide wire axial drive mechanism <NUM>.

As explained in more detail below, in one embodiment, engagement structure <NUM> includes four pairs of opposed wheels and rotational drive assembly <NUM> is supported within housing <NUM> such that rotation drive assembly <NUM> is permitted to rotate within and relative to housing <NUM>. In use, the guide wire, such as guide wire <NUM>, is received within guide wire channel <NUM> defined in chassis <NUM>, and the wheels of engagement structure <NUM> engage guide wire <NUM> between the wheels of each pair and apply sufficient normal force to guide wire <NUM> (i.e., the force perpendicular to the outer surface of guide wire <NUM>) such that the rotation of rotational drive assembly <NUM> causes guide wire <NUM> to rotate about its longitudinal axis along with rotational drive assembly <NUM> as rotational drive assembly <NUM> rotates. Rotational drive mechanism <NUM> includes a rotation bevel gear <NUM> that is configured to be coupled to capstan <NUM> of motor drive base <NUM> such that rotational drive assembly <NUM> rotates in response to rotation of capstan <NUM>.

<FIG> shows cover <NUM> and cover <NUM> in the open positions. When cover <NUM> and cover <NUM> are in the open positions, guide wire axial drive mechanism <NUM>, working catheter axial drive mechanism <NUM>, and rotational drive mechanism <NUM> are exposed allowing the user to load cassette <NUM> with a guide wire and working catheter. Once the guide wire and working catheter are positioned within guide wire channel <NUM>, guide wire channel <NUM> and working catheter channel <NUM>, respectively, engagement surfaces of guide wire axial drive mechanism <NUM>, rotational drive mechanism <NUM> and working catheter axial
drive mechanism <NUM> are brought into engagement with the guide wire and working catheter respectively. With the engagement structures of the respective drive mechanisms engaged, a user may operate controls <NUM> at workstation <NUM> to cause movement the guide wire and the working catheter.

Guide wire axial drive mechanism <NUM> includes a drive element <NUM>, a first roller assembly <NUM>, a second roller assembly <NUM>, and a guide wire axial motion sensor assembly, shown as encoder assembly <NUM> (first roller assembly <NUM> and second roller assembly <NUM> are shown in broken lines in <FIG>). Drive element <NUM> includes a drive shaft <NUM> and a drive wheel <NUM>. Drive shaft <NUM> is configured to engage second capstan <NUM> of motor drive base <NUM> such that drive shaft <NUM> and drive wheel <NUM> rotate in response to rotation of second capstan <NUM>. First roller assembly <NUM> includes an idler wheel or roller <NUM>. Second roller assembly <NUM> includes an idler wheel or roller <NUM>, and encoder assembly <NUM> includes shaft <NUM>, idler wheel or roller <NUM> and a magnetic coupling located at the lower end of shaft <NUM>.

Drive wheel <NUM> includes an outer or engagement surface, and roller <NUM> includes an outer or engagement surface. Referring to <FIG>, the "use" or "engaged" position of guide wire axial drive mechanism <NUM> is shown. Generally, when guide wire axial drive mechanism <NUM> is placed in the "use" or "engaged" position, guide wire <NUM> is positioned between drive wheel <NUM> and roller <NUM> such that the outer, circumferential surface of drive wheel <NUM> and the outer, circumferential surface of roller <NUM> engage the guide wire. In this embodiment, the outer surfaces of drive wheel <NUM> and roller <NUM> define a pair of engagement surfaces. The normal force (i.e., the force perpendicular to the surface of guide wire <NUM>) applied to guide wire <NUM> by drive wheel <NUM> and roller <NUM> is such that the friction between drive wheel <NUM> and guide wire <NUM> is sufficiently high that drive wheel <NUM> is able to impart axial motion to guide wire <NUM> in response to the rotation of drive shaft <NUM> caused by rotation of second capstan <NUM>. This axial motion allows a user to advance and/or retract a guide wire via manipulation of controls <NUM> located at workstation <NUM>. Roller <NUM> is rotatably mounted within wheel housing <NUM> and rotates freely as drive wheel <NUM> rotates to drive guide wire <NUM>.

In the "engaged" position shown in <FIG>, guide wire <NUM> is positioned between roller <NUM> and roller <NUM> such that the outer, circumferential surfaces of roller <NUM> and of roller <NUM> engage the guide wire. In this embodiment, the outer surfaces of roller <NUM> and of roller <NUM> define a pair of engagement surfaces and form part of an engagement structure of encoder assembly <NUM>. Both rollers <NUM> and <NUM> are mounted to rotate freely as drive wheel <NUM> imparts axial motion to guide wire <NUM>, and the normal force applied to guide wire <NUM> by the outer surfaces of roller <NUM> and of roller <NUM> is such that drive wheel <NUM> is able to pull guide wire <NUM> past roller <NUM> and <NUM>. In this way, the pair of non-active or idle rollers <NUM> and <NUM> help support guide wire <NUM> and maintain alignment of guide wire <NUM> along the longitudinal axis of cassette <NUM>. Roller <NUM> is rotatably mounted within wheel housing <NUM> and roller <NUM> is rotatably mounted to shaft <NUM>, and both roller <NUM> and <NUM> rotate freely as drive wheel <NUM> moves (e.g., pulls or pushes) guide wire <NUM> past roller wheels <NUM> and <NUM>.

Guide wire axial drive mechanism <NUM> includes a first spring <NUM> and a second spring <NUM>. Spring <NUM> is biased to exert a force onto wheel housing <NUM> causing roller <NUM> to engage guide wire <NUM> against drive wheel <NUM> generating the normal force noted above. Spring <NUM> is selected such that the proper amount of normal force is applied to guide wire <NUM> by the engagement surfaces of drive wheel <NUM> and roller wheel <NUM> in the "engaged" position. Spring <NUM> is biased to exert a force onto wheel housing <NUM> causing roller <NUM> to engage guide wire <NUM> against roller <NUM>. Spring <NUM> is selected such that the proper amount of normal force is applied to guide wire <NUM> by the engagement surfaces of rollers <NUM> and <NUM> in the "engaged" position to support the guide wire while still allowing the guide wire to be moved axially by drive wheel <NUM>. In other embodiments, wheels <NUM> and <NUM> may be moved into engagement with guide wire <NUM> via another mechanism that does not utilize springs <NUM> and <NUM>. For example, housing <NUM> and housing <NUM> may be coupled to a linkage that allows wheels <NUM> and <NUM> to be moved to a plurality of positions relative to wheels <NUM> and <NUM>, and the normal force applied to guide wire <NUM> is adjusted by varying the distance between wheels <NUM> and <NUM> and between wheels <NUM> and <NUM> when the wheels engage guide wire <NUM>. In one embodiment, springs <NUM> and <NUM> may be tuned and/or adjusted to modify the force applied to guide wire <NUM> by the wheels of guide wire axial drive mechanism <NUM>.

Because the ability of guide wire axial drive mechanism <NUM> to move guide <NUM> may be effected by the friction between the wheels of the drive assembly and guide wire <NUM>, the engagement surfaces of one or more of wheels <NUM>, <NUM>, <NUM> and <NUM> may be configured to ensure the proper amount of friction is applied to guide wire <NUM>. In particular, the engagement surface of drive wheel <NUM> and the engagement surface of roller wheel <NUM> may be textured (e.g., non-smooth, treaded, slotted, etc.) to increase friction between the wheels and the guide wire. Particular embodiments of a wheel for a robotic catheter system, including a textured engagement surface, are shown and described in detail in <CIT>.

Thus, the friction or grip between the wheels of guide wire axial drive mechanism <NUM> and guide wire <NUM> is a function of the surface properties of the wheels, the surface properties of the guide wire and the normal force exerted between the wheels and the outer surface of the guide wire. The friction between the wheels of guide wire axial drive mechanism <NUM> and guide wire <NUM> is a factor in how rotational energy is transferred from drive wheel <NUM> to guide wire <NUM> and in how guide wire <NUM> is moved in response to the transferred energy. As explained in more detail below, by controlling or varying one or more of the properties related to the friction within guide wire axial drive mechanism <NUM>, movement of guide wire <NUM> can be controlled.

Encoder assembly <NUM> includes magnetic coupling at the base of shaft <NUM> that engages a magnetic encoder located within motor drive base <NUM>. The magnetic encoder is configured to measure an aspect (e.g., speed, position, acceleration, etc.) of axial movement of the guide wire. As roller <NUM> rotates, shaft <NUM> rotates causing the magnetic coupling to rotate. The rotation of magnetic coupling causes rotation of the magnetic encoder within motor drive base <NUM>. Because rotation of roller <NUM> is related to the axial movement of guide wire <NUM>, the magnetic encoder within motor drive base <NUM> is able to provide a measurement of the amount of axial movement experienced by guide wire <NUM> during a procedure. This information may be used for a variety of purposes. For example, this information may be displayed to a user at workstation <NUM>, may be used in a calculation of or estimated position of the guide wire within the vascular system of a patient, may trigger an alert or alarm indicating a problem with guide wire advancement, etc. Further, as discussed below, this information may be used by procedure control module <NUM> to calculate and to vary the amount of force or torque being applied to guide wire <NUM> by drive wheel <NUM>.

Axial drive assembly <NUM> also includes working catheter axial drive mechanism <NUM>. Working catheter axial drive mechanism <NUM> includes a drive element <NUM> and a working catheter axial motion sensor assembly, shown as working catheter encoder assembly <NUM>. Drive element <NUM> includes a drive shaft <NUM> and a drive wheel <NUM>. Drive shaft <NUM> is configured to engage first capstan <NUM> of motor drive base <NUM> such that drive shaft <NUM> and drive wheel <NUM> rotate in response to rotation of first capstan <NUM>. Encoder assembly <NUM> includes shaft <NUM> and a roller <NUM>, and a magnetic coupling located at the lower end of shaft <NUM>.

Drive wheel <NUM> includes an outer surface and roller <NUM> includes an outer surface. When working catheter axial drive mechanism <NUM> is in the "engaged" position, working catheter <NUM> is positioned between drive wheel <NUM> and roller <NUM>, such that outer surfaces of drive wheel <NUM> and roller <NUM> engage working catheter <NUM>. In this embodiment, the outer surfaces of drive wheel <NUM> and roller <NUM> define a pair of engagement surfaces. The force applied to working catheter <NUM> by the outer surfaces of drive wheel <NUM> and roller <NUM> is such that drive wheel <NUM> is able to impart axial motion to the working catheter in response to the rotation of drive shaft <NUM> caused by rotation of first capstan <NUM>. This axial motion allows a user to advance and/or retract a working catheter via manipulation of controls <NUM> located at workstation <NUM>. Roller <NUM> is rotatably mounted to shaft <NUM> and rotates freely as drive wheel <NUM> rotates to drive the working catheter.

Encoder assembly <NUM> includes a magnetic coupling located at the lower end of shaft <NUM> that engages a magnetic encoder located within motor drive base <NUM>. The magnetic encoder is configured to measure an aspect (e.g., speed, position, acceleration, etc.) of axial movement of the working catheter. As roller <NUM> rotates, shaft <NUM> rotates causing the magnetic coupling to rotate. The rotation of the magnetic coupling causes rotation of the magnetic encoder within motor drive base <NUM>. Because rotation of roller <NUM> is related to the axial movement of working catheter <NUM>, the magnetic encoder within motor drive base <NUM> is able to provide a measurement of the amount of axial movement experienced by the working catheter during a procedure. This information may be used for a variety of purposes. For example, this information may be displayed to a user at workstation <NUM>, may be used in a calculation of or estimated position of the working catheter within the vascular system of a patient, may trigger an alert or alarm indicating a problem with working catheter advancement, etc. Further, as discussed below in relation to the guide wire motor, this information may be used by procedure control module <NUM> to calculate and to vary the amount of force or torque being applied to working catheter <NUM> by drive wheel <NUM>.

<FIG> and <FIG> show perspective views of rotational drive assembly <NUM> showing cover <NUM> in the open position. Rotational drive assembly <NUM> includes rotational drive mechanism <NUM>, chassis <NUM>, an engagement structure <NUM>, and a disengagement assembly <NUM>. Chassis <NUM> fits over engagement structure <NUM> and provides mounting for various components of rotational drive assembly <NUM>. Chassis <NUM> includes a front shaft <NUM> and a rear shaft <NUM>. Front shaft <NUM> is rotatably received within a collar (shown in broken lines) of top deck <NUM>, and rear shaft <NUM> is rotatably received within collar <NUM> such that rotational drive mechanism <NUM> is able to rotate relative to journal <NUM>. As shown, collar <NUM> extends through and is supported by journal <NUM> such that rear shaft <NUM> rotates within collar <NUM> as rotational drive mechanism <NUM> is rotated. Collar <NUM> rests within a recess or slot formed within journal <NUM>. In another embodiment, rear shaft <NUM> may be in direct contact with journal <NUM> such that rear shaft <NUM> rotates within the recess or slot of journal <NUM> as rotational drive mechanism <NUM> is rotated. Guide wire channel <NUM> extends the length of chassis <NUM> through both front shaft <NUM> and rear shaft <NUM>.

Rotational drive mechanism <NUM> includes rotation bevel gear <NUM> that engages a drive gear <NUM>. Bevel gear <NUM> is rigidly coupled to front shaft <NUM> of chassis <NUM> such that rotation of bevel gear <NUM> rotates chassis <NUM>. Drive gear <NUM> is coupled to a rotational actuator positioned in motor drive base <NUM> and engages bevel gear <NUM>. Rotation of the rotational actuator in motor drive base <NUM> causes drive gear <NUM> to rotate which causes bevel gear <NUM> to rotate which in turn causes rotational drive mechanism <NUM> to rotate. Rotational drive mechanism <NUM> is allowed to rotate about the longitudinal axis of guide wire channel <NUM> via the rotatable connections between front shaft <NUM> and top deck <NUM> and between rear shaft <NUM> and journal <NUM>. Bevel gear <NUM> further includes a slot <NUM> in axial alignment with guide wire channel <NUM>. Slot <NUM> allows the user to place guide wire <NUM> into guide wire channel <NUM> by dropping it in vertically as opposed to threading it through bevel gear <NUM>. In one embodiment, rotational drive assembly <NUM> is equipped with one or more sensors that are configured to measure an aspect (e.g., speed, position, acceleration, etc.) of rotation of the guide wire and/or any other structure of rotational drive assembly <NUM>. The sensors that measure rotation of the guide wire may include magnetic encoders and/or optical sensors as discussed above regarding the sensors that measure axial motion of the guide wire and/or working catheter. However, any suitable sensor (e.g., resolvers, sychros, potentiometers, etc.) may be used to detect rotation of the guide wire.

Referring to <FIG>, engagement structure <NUM> is shown according to an exemplary embodiment. As shown, engagement structure <NUM> includes four pairs of idler wheels or rollers. Each pair of rollers includes a fixed wheel <NUM> and an engagement wheel <NUM>. Fixed wheels <NUM> are rotatably coupled to chassis <NUM> via fixation posts <NUM>. Each engagement wheel <NUM> is part of an engagement wheel assembly <NUM>. Each engagement
wheel assembly <NUM> includes a pivot yoke <NUM> and a spring <NUM>. Each engagement wheel is mounted to pivot yoke <NUM> via a mounting post <NUM>. Each pivot yoke <NUM> is pivotally coupled to chassis <NUM> via fixation posts <NUM>.

Each fixed wheel <NUM> includes an outer or engagement surface <NUM> and each engagement wheel <NUM> includes an outer or engagement surface <NUM>. Generally, <FIG> and <FIG> show engagement structure <NUM> in the "use" or "engaged" position. In the "engaged" position, guide wire <NUM> is positioned between fixed wheels <NUM> and engagement wheels <NUM> such that engagement surfaces <NUM> and <NUM> are able to engage guide wire <NUM>. In this embodiment, engagement surface <NUM> and engagement surface <NUM> of each pair of rollers define a pair of engagement surfaces. The normal force applied to guide wire <NUM> by engagement surfaces <NUM> and <NUM> is sufficient to cause the guide wire to rotate about its longitudinal axis as rotational drive assembly <NUM> is rotated within the housing of cassette <NUM>. Further, the force applied to guide wire <NUM> by engagement surfaces <NUM> and <NUM> is also sufficient to allow the guide wire to be moved axially by guide wire axial drive mechanism <NUM>.

Springs <NUM> are biased to exert a force onto pivot yokes <NUM> causing each engagement wheel <NUM> to engage the opposite fixed wheel <NUM>. The generally L-shape of pivot yoke <NUM> allows springs <NUM> to be aligned with the longitudinal axis of guide wire <NUM> and still cause engagement between engagement wheels <NUM>, fixed wheels <NUM>, and the guide wire. This allows the lateral dimension of rotational drive assembly <NUM> to be less than if springs <NUM> were positioned perpendicular to the longitudinal axis of the guide wire. Springs <NUM> are selected, tuned, and/or adjusted such that the proper amount of normal force is applied to the guide wire by engagement surfaces <NUM> and <NUM> in the "engaged" position.

Cassette <NUM> also includes a series of magnets <NUM> located beneath guide wire channel <NUM>. Because, in at least some embodiments the guide wire is made from a magnetic material, magnets <NUM> are able to interact with the guide wire. In this embodiment, the magnetic attraction created by magnets <NUM> helps the user position guide wire <NUM> during loading by drawing guide wire <NUM> into guide wire channel <NUM>. The magnetic attraction created by magnets <NUM> also tends to hold guide wire <NUM> within guide wire channel <NUM> during advancement and/or retraction of the guide wire. Further, magnets <NUM> help to hold guide wire <NUM> straight (i.e., parallel to the longitudinal axis of guide wire channel <NUM>) to aid in the axial movement caused by guide wire axial drive mechanism <NUM>.

Rotational drive assembly also includes a disengagement assembly <NUM>. Disengagement assembly <NUM> includes a stepped collar <NUM>, a base plate <NUM>, and a spring <NUM>. Stepped collar <NUM> is coupled to base plate <NUM>, and spring <NUM> is coupled at one end to chassis <NUM> and at the other end to base plate <NUM>. Stepped collar <NUM> includes a slot <NUM> in axial alignment with guide wire channel <NUM>. Like slot <NUM>, slot <NUM> allows the user to place guide wire <NUM> into guide wire channel <NUM> by dropping it in vertically as opposed to threading it through stepped collar <NUM>. Base plate <NUM> includes a plurality of engagement arms <NUM> that extend generally perpendicular to the plane defined by base plate <NUM>.

Generally, disengagement assembly <NUM> allows engagement wheels <NUM> to be moved away from fixed wheels <NUM>. Referring to <FIG> and <FIG> shows a top view of rotational drive assembly <NUM> in the disengaged configuration, and <FIG> shows a top view of rotational drive assembly <NUM> in the engaged configuration. To cause engagement wheels <NUM> to disengage from guide wire <NUM>, an axially directed force (depicted by the arrow in <FIG>) is applied to stepped collar <NUM>. This causes base plate <NUM> to move toward the front of cassette <NUM> in the direction of the arrow. As base plate <NUM> moves forward, spring <NUM> is compressed, and engagement arms <NUM> are brought into contact with pivot yokes <NUM>. The contact between engagement arms <NUM> and pivot yokes <NUM> causes springs <NUM> to be compressed, and pivot yokes <NUM> pivot about fixation posts <NUM>. As pivot yokes <NUM> pivot, engagement wheels <NUM> are drawn away from fixed wheels <NUM> such that engagement wheels <NUM> and fixed wheels <NUM> are not in contact with guide wire <NUM>. As shown in <FIG>, this provides sufficient space between engagement wheels <NUM> and fixed wheels <NUM> to allow the user to place guide wire <NUM> into guide wire channel <NUM>, and, as explained below, also allows for the reduction of friction or drag that is exerted on the guide wire by rotational drive mechanism <NUM> during axial movement.

When the axial force is removed from stepped collar <NUM>, engagement wheels <NUM> move from the position shown in <FIG> to the "engaged" position shown in <FIG>. When the axial force is removed, spring <NUM> and springs <NUM> are allowed to expand causing engagement arms <NUM> to disengage from pivot yokes <NUM>. Pivot yokes <NUM> pivot counterclockwise about fixation posts <NUM>, bringing engagement wheels <NUM> back toward guide wire channel <NUM> causing engagement surfaces <NUM> of fixed wheels <NUM> and engagement surfaces <NUM> of engagement wheels <NUM> to engage guide wire <NUM>.

In one embodiment, a user may activate controls located at workstation <NUM> to cause rotational drive assembly <NUM> to move between the engaged position of <FIG> and the disengaged position of <FIG>. In one embodiment, rotational drive assembly may be placed in the disengaged position of <FIG> in response to the user input to facilitate loading and unloading of the guide wire. In one such embodiment, rotational drive assembly <NUM> is automatically rotated such that guide wire channel <NUM> is facing generally upward to allow for easy loading or removal of the guide wire. In the embodiment shown, chassis <NUM> rotates relative to stepped collar <NUM>. In this embodiment, when rotational drive assembly <NUM> is in the "loading" position, a path defined by the engagement surfaces of engagement structure <NUM> and guide wire channel <NUM> align with slot <NUM> of stepped collar <NUM>. With guide wire channel <NUM> facing upward, cover <NUM> is moved from the closed position to the open position allowing the user to access guide wire channel <NUM> to either remove or install the guide wire.

Motor drive base <NUM> may include a structure (e.g., structure <NUM> shown in <FIG> and discussed in more detail below) that applies the axial force to stepped collar <NUM> in response to a user's activation of controls located at workstation <NUM>. The structure applies the axial force to the stepped collar <NUM> to cause engagement structure <NUM> to disengage from the guide wire as discussed above. In one embodiment, cassette <NUM> and/or motor drive base <NUM> may also include one or more motors or other actuators that cause the covers of cassette <NUM> to open in response to a user's activation of controls at workstation <NUM>.

Referring to <FIG>, a block diagram of controller <NUM> is shown according to an exemplary embodiment. Controller <NUM> may generally be an electronic control unit suitable to provide catheter procedure system <NUM> with the various functionalities described herein. For example, controller <NUM> may be an embedded system, a dedicated circuit, a general purpose system programmed with the functionality described herein, etc. Controller <NUM> includes a processing circuit <NUM>, memory <NUM>, communication module or subsystem <NUM>, communication interface <NUM>, procedure control module or subsystem <NUM>, simulation module or subsystem <NUM>, assist control module or subsystem <NUM>, mode selection module or subsystem <NUM>, inventory module or subsystem <NUM>, GUI module or subsystem <NUM>, data storage module or subsystem <NUM>, and record module or subsystem <NUM>.

Processing circuit <NUM> may be a general purpose processor, an application specific processor (ASIC), a circuit containing one or more processing components, a group of distributed processing components, a group of distributed computers configured for processing, etc., configured provide the functionality of module or subsystem components <NUM>, <NUM>-<NUM>. Memory <NUM> (e.g., memory unit, memory device, storage device, etc.) may be one or more devices for storing data and/or computer code for completing and/or facilitating the various processes described in the present disclosure. Memory <NUM> may include volatile memory and/or non-volatile memory. Memory <NUM> may include database components, object code components, script components, and/or any other type of information structure for supporting the various activities described in the present disclosure.

According to an exemplary embodiment, any distributed and/or local memory device of the past, present, or future may be utilized with the systems and methods of this disclosure.

According to an exemplary embodiment, memory <NUM> is communicably connected to processing circuit <NUM> and module components <NUM>, <NUM>-<NUM> (e.g., via a circuit or any other wired, wireless, or network connection) and includes computer code for executing one or more processes described herein. A single memory unit may include a variety of individual memory devices, chips, disks, and/or other storage structures or systems.

Module or subsystem components <NUM>, <NUM>-<NUM> may be computer code (e.g., transitory program instructions, nontransitory program instructions, object code, program code, compiled code, script code, executable code, or any combination thereof), hardware, software, or any combination thereof, for conducting each module's respective functions. Module components <NUM>, <NUM>-<NUM> may be stored in memory <NUM>, or in one or more local, distributed, and/or remote memory units configured to be in communication with processing circuit <NUM> or another suitable processing system.

Communication interface <NUM> includes one or more component for communicably coupling controller <NUM> to the other components of catheter procedure system <NUM> via communication links <NUM>. Communication interface <NUM> may include one or more jacks or other hardware for physically coupling communication links <NUM> to controller <NUM>, an analog to digital converter, a digital to analog converter, signal processing circuitry, and/or other suitable components. Communication interface <NUM> may include hardware configured to connect controller <NUM> with the other components of catheter procedure system <NUM> via wireless connections. Communication module <NUM> is configured to support the communication activities of controller <NUM> (e.g., negotiating connections, communication via standard or proprietary protocols, etc.).

Data storage module <NUM> is configured to support the storage and retrieval of information by controller <NUM>. In one embodiment, data storage module <NUM> is a database for storing patient specific data, including image data. In another embodiment, data storage module <NUM> may be located on hospital network <NUM>. Data storage module <NUM> and/or communication module <NUM> may also be configured to import and/or export patient specific data from hospital network <NUM> for use by controller <NUM>.

Controller <NUM> also includes simulation module or subsystem <NUM>, assist module or subsystem <NUM>, mode selection module or subsystem <NUM>, inventory module or subsystem <NUM>, GUI module or subsystem <NUM>, data storage module or subsystem <NUM>, and record module or subsystem <NUM>. Generally, simulation module <NUM> is configured to run a simulated catheterization procedure based upon stored vascular image data and also based upon a user's manipulation of controls <NUM>. Generally, assist module <NUM> is configured to provide information to the user located at workstation <NUM> during a real and/or simulated catheterization procedure to assist the user with the performance of the procedure. Specific embodiments of controller <NUM>, including specific embodiments of simulation module <NUM>, and assist module <NUM>, are described in detail in P. International Application No. <CIT>, which is incorporated herein by reference in its entirety. Other specific embodiments of controller <NUM>, including specific embodiments of GUI module <NUM>, are described in P. International Application No. <CIT>.

Controller <NUM> also includes a procedure control module <NUM> configured to support the control of bedside system <NUM> during a catheter based medical procedure. Procedure control module <NUM> allows the user to operate bedside system <NUM> by manipulating controls <NUM>. In various embodiments, procedure control module <NUM> is configured to generate one or more control signals <NUM> based upon a first user input (e.g., the user's manipulation of controls <NUM>) and, in some embodiments, also based upon a second input such as various data and information available to procedure control module <NUM>. In various embodiments discussed in more detail below, the second input includes information related to the catheter device. As shown in <FIG>, control signals <NUM> generated by procedure control module <NUM> are communicated from controller <NUM> to the actuators or motors of bedside system <NUM>. In response to control signals <NUM>, the motors of bedside system <NUM> drive the drive mechanisms of cassette <NUM> (e.g., guide wire axial drive mechanism <NUM>, working catheter axial drive mechanism <NUM>, guide wire rotational drive mechanism <NUM>, etc.) to cause movement of the guide wire or working catheter in accordance with the manipulation of controls <NUM> by the user. Procedure control module <NUM> may also cause data appropriate for a particular procedure to be displayed on monitors <NUM> and <NUM>. Procedure control module <NUM> may also cause various icons (e.g., icons <NUM>, <NUM>, <NUM>, etc.) to be displayed on touch screen <NUM> that the user may interact with to control the use of bedside system <NUM>.

Referring to <FIG>, a block diagram of catheter procedure system <NUM> is shown according to an exemplary embodiment. In the exemplary embodiment of <FIG>, motor drive base <NUM> includes working catheter axial drive motor <NUM>, guide wire axial drive motor <NUM>, a guide wire rotational drive motor <NUM>, a power supply <NUM>, and a disengagement actuator <NUM>. Working catheter axial drive motor <NUM> drives capstan <NUM>, guide wire axial drive motor <NUM> drives capstan <NUM> and guide wire rotational drive motor <NUM> drives capstan <NUM> to cause movement of working catheter <NUM> and guide wire <NUM>, as discussed above. Motors <NUM>, <NUM> and <NUM> are in communication with controller <NUM> such that control signals <NUM> may be received by motors <NUM>, <NUM> and <NUM>. Motors <NUM>, <NUM> and <NUM> respond to control signals <NUM> by varying the rotation of capstans <NUM>, <NUM> and <NUM> thereby varying the movement of working catheter <NUM> and guide wire <NUM> caused by drive mechanisms <NUM>, <NUM> and <NUM>. As shown, motor drive base <NUM> also includes a power supply <NUM> that may be, for example, a battery, the AC building power supply, etc..

Movement of a percutaneous device using a robotic system may be effected by a number of interrelated factors. For example, movement of a percutaneous device may be effected by the friction between the percutaneous device and the portions of the engagement structure imparting movement to the device (e.g., drive wheel <NUM>) and also on the friction between the percutaneous device and non-active or supporting portions of the engagement structure (e.g., roller wheels <NUM>, <NUM> and <NUM>). Movement of a percutaneous device may be effected by on the friction or drag applied to the percutaneous device by other structures within the system, and it may also be effected by the characteristics (e.g., power, torque, etc.) of the motor or other actuator that is responsible for generating the energy that results in movement of the percutaneous device. In various embodiments, catheter procedure system <NUM> is configured to provide for adaptable or adjustable control over the manner in which the percutaneous device is moved by catheter procedure system <NUM>. In such embodiments, catheter procedure system <NUM> may be configured to provide for variability and user control over one or more of the factors that relate to the manner in which a percutaneous device is moved by catheter procedure system <NUM>. Providing variability allows the movement of the percutaneous device by catheter procedure system <NUM> to be adjusted to suit the specific needs of a particular situation (e.g., particular types of
percutaneous devices, different types of procedures, particular anatomy being navigated, the particular disease being treated, particular user preferences, etc.).

In various embodiments, catheter procedure system <NUM> is configured to provide for the variation of the torque and/or rotational speed of an actuator, such as guide wire axial motor <NUM>. <FIG> is a flow diagram generally showing control and variation of drive torque by catheter procedure system <NUM> according to an exemplary embodiment. At step <NUM>, a user input is received, and at step <NUM> a second input is received. At step <NUM> a control signal is generated based on the user input and the second input, and the generated control signal is communicated to one of the actuators that provides torque to the drive mechanism of bedside system <NUM>. The torque generated in response to the control signal by the actuator may be varied, controlled or limited as discussed herein. At step <NUM>, the actuator provides torque to the drive mechanism based on the control signal, and at step <NUM> the percutaneous device is moved by the drive mechanism.

In some embodiments, procedure control module <NUM> and/or guide wire axial drive motor <NUM> may be configured to provide for variability and control of the axial force (i.e., the force directed along the longitudinal axis of guide wire <NUM> that results in advancement and retraction of guide wire <NUM>) applied to guide wire <NUM> by drive wheel <NUM> during advancement and retraction of guide wire <NUM>. Variability and control of the axial force applied to guide wire <NUM> may be desirable for various reasons including, providing improved ability to traverse a partial occlusion or chronic total occlusion (collectively referred to as "CTO"), etc. In various embodiments, variability and control of the axial force applied to guide wire <NUM> is achieved by varying the current and/or voltage supplied to guide wire axial drive motor <NUM> from power supply <NUM>. This control of guide wire axial drive motor <NUM> acts to vary the rotational speed and/or torque that guide wire axial drive motor <NUM> imparts to guide wire <NUM> via capstan <NUM> and drive wheel <NUM>.

In some embodiments, variation of current and/or voltage supplied to guide wire axial drive motor <NUM> from power supply <NUM> (and the corresponding variation in the rotational speed and/or torque that guide wire axial drive motor <NUM> imparts to guide wire <NUM>) occurs in response to control signals <NUM> generated by procedure control module <NUM>. Control signals <NUM> may be based upon a user input (e.g., the user's operation of controls <NUM>) and based upon a second input (e.g., other information or data available to procedure control module <NUM>, an additional user input, etc.), and the actuator may provide torque to a percutaneous device (e.g., the guide wire) via a drive mechanism in response to the control signal. Procedure control module <NUM> is described as being configured to control, limit, vary, etc. the torque provided an actuator, such as guide wire axial drive motor <NUM>, based on various inputs (e.g., information, data, operating conditions, etc.) and/or based upon user inputs received by a user interface (e.g., controls <NUM>). It should be understood that, in one embodiment, the functionalities provided by control module <NUM> discussed herein are provided by generating control signals <NUM> based upon the various inputs, and the control signals <NUM> are transmitted or communicated to an actuator (e.g., guide wire actuator <NUM>). In this embodiment, the actuator then provides or generates a torque to a drive mechanism in response to the control signal.

During some intervention procedures, it is necessary that the guide wire traverse a partial or total occlusion of the coronary arteries. During these procedures, the guide wire must be advanced with enough axial force such that the guide wire pushes through the occlusion. However once the guide wire is through the occlusion it may be desirable to reduce the amount of torque the motor provides to drive the guide wire. Thus, in various embodiments, guide wire axial drive motor <NUM> is a motor having torque and speed characteristics such that it provides increased torque during traversal of the occlusion. For example, in one embodiment, guide wire axial drive motor <NUM> is configured to deliver sufficient torque via its output shaft such that the axial force imparted to guide wire <NUM> is great enough to allow guide wire <NUM> to traverse a total occlusion. In another embodiment, guide wire axial drive motor <NUM> is configured such that the maximum torque that may be delivered via its output shaft is such that the axial force imparted to guide wire <NUM> is not sufficient to traverse the occlusion.

In another embodiment, guide wire axial drive motor <NUM> is selected to have a relatively low maximum output shaft speed (i.e., the no-load speed of the motor) to prevent sudden unwanted acceleration of guide wire <NUM>. For example, the output speed of the motor shaft may be varied so as to not provide sufficient axial force to traverse the occlusion. This lower force may be useful when navigating the guide wire to the occlusion, or after the guide wire has traveled through the occlusion. A reduction in motor torque may be desirable once the guide wire has traversed an occlusion, such as a CTO, with guide wire <NUM>. This will limit the guide wire from accelerating once the load of the occlusion has passed. This potential unwanted acceleration of guide wire <NUM> can be minimized by selecting a guide wire axial drive motor <NUM> with a low maximum output shaft speed or with a controller that controls the speed to a constant speed at a given input by the operator. For example, if the operator moves a joystick a certain distance from a neutral position, the speed will remain constant even if the torque is modified for a portion of the travel distance of the guide wire.

In other embodiments, procedure control module <NUM> is configured to control the voltage and/or current supplied to guide wire axial drive motor <NUM> by power supply <NUM> in order to control and vary the axial force applied to guide wire <NUM> by drive wheel <NUM> based upon a first user input and a second input. In one embodiment, procedure control module <NUM> is configured to limit the maximum speed and maximum torque supplied by guide wire axial drive motor <NUM> based upon an input indicative of the current location of the tip of the guide wire within the patient's vascular system. Thus, in this embodiment, control signal <NUM> generated by procedure control module <NUM> may be based upon information related to the location of the tip of the guide wire within the patient and based upon the user's operation of controls <NUM>. For example, procedure control module <NUM> may be configured such that the maximum speed and/or maximum torque supplied by guide wire axial drive motor <NUM> is set higher when the tip of the guide wire is located with the large arteries (e.g., aorta, femoral artery, etc.) and the maximum speed and/or maximum torque supplied by guide wire axial drive motor <NUM> is set lower when the tip of the guide wire is located with the smaller arteries (e.g., coronary arteries, etc.). In such embodiments, procedure control module <NUM> may be configured to determine the information related to the location of the tip of the guide wire in various way. For example, procedure control module <NUM> may prompt the user to input the current location of the tip of the guide wire via controls <NUM> (e.g., touch screen <NUM>), location of the guide wire tip may be determined by image processing of images captured via imaging system <NUM>, or the location may be determined via the distance information captured by a guide wire axial motion sensor assembly, such as encoder assembly <NUM>, discussed above.

In another embodiment, procedure control module <NUM> is configured to limit the maximum speed and/or maximum torque supplied by guide wire axial drive motor <NUM> based upon an input indicative of the type of movement being preformed by the guide wire. Thus, in one embodiment, control signal <NUM> generated by procedure control module <NUM> may be based upon information related to the direction of movement of the guide wire and based upon the user's operation of controls <NUM>. For example, procedure control module <NUM> may be configured such that the maximum torque and/or speed supplied by guide wire axial drive motor <NUM> is set lower when the guide wire is being advanced and the maximum
torque and/or speed supplied by the guide wire axial drive motor <NUM> is set higher when the guide wire is being retracted. This arrangement may be desirable because blood vessel perforation may be less likely when the guide wire is being retracted.

In other embodiments, procedure control module <NUM> may be configured to control the torque and speed supplied by guide wire axial drive motor <NUM> to assist in traversal of an occlusion such as a CTO. Thus, in one embodiment, control signal <NUM> generated by procedure control module <NUM> may be based upon an input indicative of information related to whether the tip of the percutaneous device is traversing an occluded portion of a vessel of the patient's vascular system and based upon the user's operation of controls <NUM>. For example, procedure control module <NUM> may be configured such that the maximum torque supplied by guide wire axial drive motor <NUM> is set higher and the maximum speed supplied by guide wire axial drive motor <NUM> is set lower during traversal of a CTO. In this embodiment, controls <NUM> (e.g., touch screen <NUM>) may include a button that the user selects when occlusion or CTO traversal is about to start, and selection of the button by the user provides a user input that activates the occlusion or CTO traversal limits discussed above. In other embodiments, procedure control module <NUM> may determine that occlusion or CTO traversal is occurring by identifying the position of the guide wire relative to the occlusion or CTO from image information captured by imaging system <NUM>. In another embodiment, procedure control module <NUM> may be configured to determine the extent of occlusion or CTO traversal that has occurred (i.e., how far through the occlusion or CTO the guide wire has traveled), and to control the torque and speed supplied by guide wire axial drive motor <NUM> based on the extent of occlusion or CTO traversal. For example, procedure control module <NUM> may be configured to decrease the torque supplied by guide wire axial drive motor <NUM> as the guide wire nears the end of the occlusion or CTO. In one such embodiment, the extent of occlusion or CTO traversal by the guide wire is determined from image information captured by imaging system <NUM>.

In another embodiment, procedure control module <NUM> is configured to limit the maximum torque supplied by guide wire axial drive motor <NUM> such that the axial force imparted to guide wire <NUM> is low enough that guide wire <NUM> is capable of navigating through the blood vessels needed during a procedure at a proper force level. In one such embodiment, procedure control module <NUM> is configured with a set or non-variable maximum torque threshold such that the torque supplied by guide wire axial drive motor <NUM> remains below the threshold under all operating conditions. In this embodiment, the set
or non-variable maximum torque threshold is selected such that the axial force applied to the guide wire is optimized for the type of blood vessel to be traversed during a particular procedure.

In another embodiment, procedure control module <NUM> is configured with a variable maximum torque threshold that is determined based upon various data or information accessible by procedure control module <NUM>. In this embodiment, the torque supplied by guide wire axial drive motor <NUM> remains below the variable threshold during the procedure. In one such embodiment, the variable maximum torque threshold is determined from image data captured by imaging system <NUM>. Thus, in this embodiment the maximum torque threshold may be determined based upon the thickness of the blood vessel walls at a certain location identified from the image data, and procedure control module <NUM> is configured to utilize the determined torque threshold to limit the maximum allowable torque of guide wire axial drive motor <NUM> as the guide wire traverses that portion of the blood vessel. In another embodiment, the maximum torque threshold utilized by procedure control module <NUM> is based upon the characteristics of the particular guide wire being used. For example, the maximum torque threshold may be set higher for a larger diameter guide wire than for a smaller diameter guide wire.

In another embodiment, procedure control module <NUM> may be configured to allow the user to set the maximum torque and maximum speed supplied by guide wire axial drive motor <NUM>. In one embodiment, procedure control module <NUM> may display a button on touch screen <NUM> prompting the user to set the maximum torque and maximum speed. In another embodiment, controls <NUM> may include a set of controls (e.g., dials, sliders, etc.) allowing the user to set the maximum torque and maximum speed supplied by guide wire axial drive motor <NUM>. In various embodiments, the user may be able to adjust the maximum torque and maximum speed as desired through out the procedure.

In various embodiments, catheter procedure system <NUM> may be configured to limit the torque supplied by guide wire axial drive motor <NUM> to ensure that the supplied torque does not exceed a default maximum torque limit. In an embodiment in which guide wire axial drive motor <NUM> is an electric motor, procedure control module <NUM> may be configured to limit the amount of electrical current supplied to guide wire axial drive motor <NUM> by power supply <NUM> such that the torque supplied by guide wire axial drive motor <NUM> does not exceed the default maximum torque. The electrical current limit may be applied either via hardware or via computer code. In one such embodiment, procedure control module <NUM>
may be programmed to include an electrical current limit, and procedure control module <NUM> may be configured to prevent the current delivered to guide wire axial drive motor <NUM> from exceeding the current limit.

In an embodiment including a default maximum torque as shown in <FIG>, a catheter procedure system <NUM> may be provided that includes a default maximum torque limit at step <NUM>. At step <NUM>, a user input may be received, and, at step <NUM>, the default maximum torque limit may be deactivated based on the received user input. In this embodiment, the user interface of catheter procedure system <NUM> may be configured to receive the user input that allows the user to deactivate the default maximum torque. In one such embodiment, an element of controls <NUM> (e.g., an icon displayed on touch screen <NUM> such as icon <NUM>, <NUM> and <NUM>) is configured to receive one or more user inputs to allow the user to deactivate and reactivate the default maximum torque threshold as desired. In this embodiment, the user may interact with the control element to deactivate the default maximum torque limit allowing the torque provided by guide wire axial drive motor <NUM> to exceed the default threshold. This embodiment may provide greater flexibility by allowing the user of catheter procedure system <NUM> to remove the default torque limit in situations where a greater torque is desired or needed. For example, the default maximum torque limit may be deactivated during particular types of procedures, while using different types of guide wires, while navigating various portions of the vascular system, etc..

In one embodiment, if the user has deactivated the maximum torque limit, at step <NUM> a second user input may be received, and, at step <NUM>, the default maximum torque limit is reactivated in response to the second user input. In one such embodiment, the user may reactivate the default maximum torque limit by interacting with the control element to ensure that the torque provided by guide wire axial drive motor <NUM> does not exceed the default maximum limit. The user may reactivate the default maximum torque limit once the portion of the procedure that necessitated use of a higher torque is complete. In another embodiment, catheter procedure system <NUM> may be configured to automatically reactivate (e.g., to reactivate without the need for a specific user input) the default maximum torque limit. In one exemplary embodiment, procedure control module <NUM> is configured to automatically reactivate the default maximum torque limit when the user has stopped interacting with controls <NUM> to move a percutaneous device for a set period of time. In another embodiment, the default maximum limit may be reactivated prior to the start of a new procedure on a new patient.

In one embodiment, catheter procedure system <NUM> is configured to display information to the user at workstation <NUM> regarding whether the default maximum torque limit is currently active or is currently inactive. In one such embodiment, a separate icon (such as icon <NUM>, <NUM> and <NUM>) may be displayed via a display device of workstation <NUM> indicating the current status of the default maximum torque limit. In another embodiment, the control element for controlling activation and deactivation of the default maximum torque limit may be configured to provide an indication of the current status of the default max torque limit. For example, the control element may be a touch screen icon that assumes one color (e.g., gray) when the limit is inactive and another color (e.g., blue) when the limit is active.

In another embodiment, catheter procedure system <NUM> may include a default maximum torque limit, as discussed above, and a fixed or absolute maximum torque limit that may not be deactivated. In such an embodiment, the absolute maximum torque limit is greater than the default maximum torque limit and is selected to ensure that the torque supplied by guide wire axial drive motor <NUM> does not exceed the structural, safety or other limits of the guide wire or of the components of the bedside system. In one such embodiment, catheter procedure system <NUM> may be configured to allow the user to adjust or set the maximum torque limit to a maximum torque value between the default maximum torque limit and the absolute maximum torque limit. Once set, the torque limit set by the user will be applied by catheter procedure module <NUM> to ensure that the torque supplied by guide wire axial drive motor <NUM> does not exceed the set torque limit.

In some embodiments, the default maximum torque limit may be variable. For example, in some embodiments, the default maximum torque limit may be based upon one or more factor of a particular procedure that is being performed using catheter procedure system <NUM>. For example, the default maximum torque may be based on the type of procedure being performed, the type of percutaneous device being moved by bedside system <NUM>, the size of the vasculature that the percutaneous device is being navigated through, etc. This variability may help to ensure that the default maximum torque limit is set to a value that is desirable for the particular procedure that is being performed. Catheter procedure system <NUM> may be configured to automatically detect the factors needed to set the default maximum threshold for the procedure. In one embodiment, the type of percutaneous device that bedside system <NUM> is equipped with may be identified via a barcode or via an RFID tag associated with the percutaneous device, and the size of the vasculature may be
determined by processing image data showing the vessels within which the device is being moved.

In one embodiment, bedside system <NUM> may include a sensor configured to determine the amount of axial force applied to guide wire <NUM> by guide wire axial drive motor <NUM> as guide wire axial drive mechanism <NUM> advances and retracts the guide wire. In another embodiment, procedure control module <NUM> may be configured to determine the amount of axial force applied to guide wire <NUM> by guide wire axial drive motor <NUM> as guide wire axial drive mechanism <NUM> advances and retracts the guide wire by monitoring the operating state of guide wire axial drive motor <NUM>. In one embodiment, procedure control module <NUM> is configured to display information related to the determined amount of axial force to the user via a display device, such as monitors <NUM> and <NUM>. For example, the display may be a bar display that fills in as axial force increases or a dial display with a needle that indicates the determined force. The display may also provide an indication of the axial force that would result in blood vessel perforation during the procedure. This indication may be a displayed force number or may be a graphical representation, such as a threshold line, displayed on the bar display discussed above. Procedure control module <NUM> may be configured to determine the axial force that would result in blood vessel perforation based on the location of the guide wire (e.g., in the aorta, in the coronary arteries, etc.) or this determination may be calculated from the image information of the patient's vascular system. For example, the image information may provide an indication of vascular wall thickness in the area in which the tip of guide wire <NUM> is located, and the wall thickness may be used to calculate the amount of force needed to puncture a vessel wall having that thickness.

In various embodiments, catheter procedure system <NUM> is configured to control and vary the amount of friction or drag that is applied to the percutaneous devices by bedside system <NUM> during movement of the percutaneous device. Movement of the percutaneous device by bedside system <NUM> can be altered by controlling the friction experienced by the percutaneous device. For example, the axial speed (e.g., speed of advancement or retraction) and rotational speed of a percutaneous device that results from a particular drive torque can be increased by decreasing the friction or drag experienced by the percutaneous device. Conversely, the axial speed (e.g., speed of advancement or retraction) and rotational speed of a percutaneous device that results from a particular axial drive torque can be decreased by increasing the friction or drag experienced by the percutaneous device.

Friction occurs between the percutaneous device and the drive mechanism wheels, and unneeded friction can be reduced by disengaging wheels that do not need to be engaged for the current movement of the percutaneous device. Accordingly, in one embodiment, bedside system <NUM> may be operated in at least a first drive mode to move the percutaneous device when one or more unneeded engagement structure is disengaged from the percutaneous device and a second drive mode.

In one embodiment, the first drive mode is an accelerated or "high speed" axial drive mode during which one or more non-axial drive wheels of bedside system <NUM> are disengaged from the guide wire to lower the drag on the guide wire, and the second drive mode is a nonaccelerated axial drive mode during which all of the non-axial drive wheels of bedside system <NUM> are engaged with the guide wire. Thus, while in the "high speed" axial drive mode, one or more of the non-axial drive wheels (e.g., roller wheels <NUM> and <NUM> of encoder assembly <NUM>, and wheels <NUM> and <NUM> of rotational drive assembly <NUM>) may be disengaged from the guide wire to reduce the friction on the guide wire. In the "high speed" axial drive mode, the guide wire will move axially at a faster speed and will accelerate faster for a given torque supplied by guide wire axial drive motor <NUM> when compared to a movement mode in which the non-axial drive wheels of bedside system <NUM> are engaged with the guide wire.

In one embodiment of a system operable in a "high speed" axial drive mode, catheter procedure system <NUM> is configured to disengage the engagement structure (e.g., wheels <NUM> and <NUM> shown in <FIG>) of the rotational drive assembly from the guide wire when bedside system <NUM> is to be operated in "high speed" axial drive mode. In this embodiment, as shown in <FIG>, bedside system <NUM> may include a disengagement actuator <NUM> located within motor drive base <NUM> that is configured to cause disengagement of the wheels of guide wire rotational drive mechanism <NUM> when bedside system <NUM> is to be operated in the high speed axial mode. Further, controls <NUM> may include one or more control element (e.g., a touch screen icon such as icon <NUM>, <NUM> and <NUM>) configured to receive user inputs that allow the user to activate and deactivate the high speed mode. When the "high speed" mode control element is activated, a control signal <NUM> is transmitted to disengagement actuator <NUM> triggering activation of disengagement actuator <NUM> which in turn causes disengagement of the of the engagement structure of the rotational drive assembly from the guide wire. When the "high speed" mode control element is deactivated, a control signal triggers deactivation of disengagement actuator <NUM> which in
turn causes reengagement of the engagement structure of the rotational drive assembly with the guide wire.

In one exemplary embodiment, the engagement structure of the rotational drive assembly includes several sets of pairs of wheels <NUM> and <NUM> as shown in <FIG> and <FIG>. As discussed above regarding <FIG> and <FIG>, wheels <NUM> and <NUM> may be moved from the engaged position (<FIG>) to the disengaged position (<FIG>) by the application of an axial force to base plate <NUM>. The axial force causes wheels <NUM> to pivot away from wheels <NUM> such that the outer surfaces of wheels <NUM> and <NUM> no longer contact guide wire <NUM>. As shown in <FIG>, bedside system <NUM> may include a structure <NUM> that is moved by disengagement actuator <NUM> to apply the axial force to base plate <NUM>. In one embodiment, structure <NUM> is a pair of rods or arms that extend from the upper surface of motor drive base <NUM> and are positioned adjacent to base plate <NUM>.

When the user activates "high speed" axial drive mode, actuator <NUM> moves the two arms of disengagement structure <NUM> laterally (parallel to the upper surface of the motor drive base <NUM>) to engage the outer surface of base plate <NUM> and to apply the axial force to base plate <NUM> to disengage wheels <NUM> and <NUM> from guide wire <NUM>. With wheels <NUM> and <NUM> disengaged from guide wire <NUM> the friction or drag on the guide wire is decreased which allows the guide wire to be moved axially at a faster speed for a particular drive motor torque.

In one embodiment, dedicated guide wire control <NUM> (<FIG>) is a joystick type control. In this embodiment, the electric current delivered to guide wire axial motor <NUM> from power supply <NUM> is a function of the degree of displacement of the joystick, and the torque supplied by guide wire axial motor <NUM> is a function of the delivered electric current. In this embodiment, for a particular displacement of the joystick control (e.g., a particular user input), a given or predetermined torque will be supplied to guide wire axial drive mechanism <NUM> from guide wire axial motor <NUM>. Thus in the "high speed" axial mode, the speed of guide wire <NUM> for given the predetermined torque will be greater than the speed of guide wire <NUM> for the same torque when the engagement structure of the rotational drive mechanism is engaged. Further, in one embodiment, catheter procedure system <NUM> sets a maximum for the electrical current supplied to guide wire axial motor <NUM>, and, in this embodiment, the maximum speed of the guide wire is greater when bedside system <NUM> is operating in "high speed" mode than when bedside system <NUM> is operating in the regular mode.

When "high speed" axial mode is no longer needed or rotational movement is desired, a control element of controls <NUM> is actuated by the user to deactivate "high speed" axial mode. When controls <NUM> receive the input from the user indicating that the system is be moved from "high speed" mode to regular mode, the two arms of disengagement structure <NUM> are moved away from base plate <NUM> disengaging disengagement structure <NUM> from the surface of base plate <NUM> allowing wheels <NUM> and <NUM> to reengage guide wire <NUM> as discussed above. With wheels <NUM> and <NUM> engaged with guide wire <NUM>, bedside system <NUM> is then operated in the non-high speed or regular axial drive mode.

As noted above, the user may manually toggle between "high speed" and non-high speed axial drive modes by interacting with a control element of controls <NUM>. Because shortening procedure time is often advantageous, the user may select to operate bedside system <NUM> in "high speed" mode in a number of situations. In particular, the user may select "high speed" axial drive mode to perform those portions of the procedures in which slow, precise movements are not necessary. For example, high speed axial drive mode may be selected by the user when the guide wire is moving through large blood vessels and/or during retractions of the guide wire after the procedure is completed.

In another embodiment, catheter procedure system <NUM> may be configured to operate in a "high speed" rotational drive mode. Similar to the embodiments discussed above, in this embodiment, the engagement structure of the guide wire axial drive mechanism may be disengaged from the guide wire. With the friction experienced by the guide wire reduced, the rotational drive mechanism can rotate the guide wire at a faster speed or acceleration. In one such embodiment, the "high speed" rotational drive mode may be selected to facilitate rotation of the guide wire during traversal of an occluded portion of the patient's vascular system.

In some embodiments, controller <NUM> (e.g., via assist module <NUM>) may be configured to provide a suggestion to the user located at workstation <NUM> regarding whether operating in "high speed" mode is recommended, desirable, etc. In one such embodiment, the suggestion may be based upon various information available to controller <NUM>. For example, procedure control module <NUM> may determine the diameter of the blood vessel that the tip of the guide wire is in from imaging data, and if the diameter is greater than a predetermined threshold, procedure control module <NUM> may display a suggestion to the user that "high speed" mode may be enabled.

In other embodiments, controller <NUM> may be configured to limit those situations in which the user may activate "high speed" mode. For example, in one such embodiment, if the determined diameter of the blood vessel is less than a predetermined threshold, control module <NUM> may be configured to prohibit the activation of high speed mode by the user. In this embodiment, the control for activating "high speed" mode may be configured to provide an indication regarding whether "high speed" mode is available. For example, the control for activating "high speed" mode may be a touch screen icon (such as icon <NUM>, <NUM> and <NUM>) that may be displayed in a first color (e.g., grey) when "high speed" mode is not available and a second color (e.g., green) when "high speed" mode is available.

Referring to <FIG>, a method of operating a robotic catheter procedure system is shown according to an exemplary embodiment. At step <NUM>, a robotic catheter procedure system, such as the various embodiments of catheter procedure system <NUM> discussed above, is provided. At step <NUM>, the percutaneous device is engaged by at least two engagement structures of the robotic catheter system (e.g., an engagement structure of an axial drive mechanism and an engagement structure of a rotational drive mechanism). This engagement may result from control signals <NUM> generated by user interaction with controls <NUM>, as discussed above. At step <NUM>, one of the engagement structures is disengaged from the percutaneous device. This disengagement may result from a control signal <NUM> generated by the user via interaction with controls <NUM>. At step <NUM>, the engaged drive mechanism is operated to move the percutaneous device while the other engagement mechanism remains disengaged. The movement of the percutaneous device may result from a control signal <NUM> generated by the user via interaction with controls <NUM> as discussed above. At step <NUM>, the disengaged engagement structure may be reengaged with the percutaneous device. The reengagement of the engagement structure may result from a control signal <NUM> generated by the user via interaction with controls <NUM> as discussed above.

In various embodiments, catheter procedure system <NUM> may be configured to control or vary the amount of friction experienced between the engagement structure of the drive mechanism and the percutaneous device. For example, in one embodiment, catheter procedure system <NUM> may be configured to control or vary the amount of friction experienced between wheels <NUM>, <NUM>, <NUM> and <NUM> of guide wire axial drive mechanism <NUM> (shown in <FIG>) and guide wire <NUM>.

As discussed above regarding <FIG>, springs <NUM> and <NUM> exert a force to bias wheels <NUM> and <NUM> to engage guide wire <NUM> between wheels <NUM> and <NUM>, respectively. In one such embodiment, the normal force applied to guide wire <NUM> by wheels <NUM>, <NUM>, <NUM> and <NUM> generated by springs <NUM> and <NUM> (e.g., the pinch force) may be variable or controllable allowing for control of the friction between the wheels <NUM>, <NUM>, <NUM> and <NUM> and guide wire <NUM>.

In various embodiments, the pinch force may be varied to accommodate the use of a variety of different types of guide wires. For example, if cassette <NUM> is equipped with a guide wire having a rough or textured outer surface, the pinch force generated by springs <NUM> and <NUM> may be decreased to ensure the proper amount of friction between the wheels and the guide wire. In contrast, if cassette <NUM> is equipped with a guide wire having a smooth outer surface, the pinch force generated by springs <NUM> and <NUM> may be increased to ensure the proper amount of friction between the wheels and the guide wire. In other embodiments, the pinch force may be controlled to vary the performance of cassette <NUM> during a procedure. For example, the pinch force may be increased to help ensure that the guide wire remains in place (i.e., no axial motion occurs) when the controls for guide wire axial motion are not being actuated by the user and/or when the user is actuating controls for a different percutaneous device.

The pinch force may be varied or controlled by the user in various ways. For example, in one embodiment, cassette <NUM> may include one or more actuators, shown as spring force actuator <NUM> in <FIG>, configured to adjust or vary the force generated by springs <NUM> and <NUM> in response to a control signal received from controller <NUM>. Referring to <FIG>, in one embodiment, spring <NUM> is mounted at one end to wheel housing <NUM> and at the other end to mounting block <NUM>, and spring <NUM> is mounted at one end to wheel housing <NUM> and at the other end to mounting block <NUM>. In this embodiment, spring force actuator <NUM> may be a motor, such as a step motor, that engages mounting blocks <NUM> and <NUM> via a coupling element <NUM> and moves mounting blocks <NUM> and <NUM> toward guide wire <NUM> to increase the force generated by springs <NUM> and <NUM> and that moves mounting blocks <NUM> and <NUM> away from guide wire <NUM> to decrease the force generated by springs <NUM> and <NUM>.

Controls <NUM> may include a control (e.g., a button, dial, touch screen icon, etc.) that allows the user to alter the pinch force of guide wire axial drive mechanism <NUM> from workstation <NUM>. In another embodiment, controller <NUM> may be configured to automatically adjust the pinch force generated by springs <NUM> and <NUM> based upon the type of guide wire that cassette <NUM> is equipped with. Controller <NUM> may prompt the user to identify the type of
guide wire via controls <NUM> (e.g., via a drop down menu, scanning a bar code, etc.). In another embodiment, catheter procedure system <NUM> may be configured (e.g., bedside system <NUM> may be equipped with a transceiver) to automatically identify the type of guide wire that cassette <NUM> is equipped with (e.g., via reading of an RFID tag associated with the guide wire), and controller <NUM> may be configured to automatically control the pinch force based on the automatically determined guide wire type.

In another embodiment, catheter procedure system <NUM> may include a sensor that detects slippage between the wheels of guide wire axial drive mechanism <NUM> and guide wire <NUM>. Slippage may be detected in various ways including using an optical sensor to monitor actual movement of guide wire <NUM>, using an encoder or other sensor to monitor the actual movement of one of the wheels or by monitoring the current drawn by guide wire axial motor <NUM>. In this embodiment, data from the slippage sensor is received and analyzed by controller <NUM>, and if controller <NUM> detects that slippage is occurring, a control signal is generated and communicated to spring force actuator <NUM> to increase the force applied by spring <NUM> and/or spring <NUM> to wheel <NUM> and/or wheel <NUM>, depending on where slippage was detected. Slippage may be overcome in this manner because the friction between guide wire <NUM> and wheels of guide wire axial drive mechanism <NUM> increases as the pinch force generated by springs <NUM> and <NUM> increases. In another embodiment, catheter procedure system <NUM> may be configured to determine whether the pinch force between the wheels of guide wire axial drive mechanism <NUM> and guide wire <NUM> is higher than needed and to reduce the pinch force accordingly.

It should be understood that, in various embodiments, catheter procedure system <NUM> may include one or more of any of the various variable force and variable speed concepts discussed above, in any combination, to provide for additional variability in control of the percutaneous device. For example, catheter procedure system <NUM> may be configured to control or vary both the torque supplied by guide wire axial motor <NUM>, and the normal force applied to guide wire <NUM> by the wheels of guide wire axial drive mechanism <NUM>. This embodiment may provide for useful control over the movement of the percutaneous device. In one such embodiment, if high axial force is needed (e.g., to traverse a CTO), catheter procedure system <NUM> may be configured to increase the torque generated by guide wire axial motor <NUM> to generate the higher axial force needed to push through the CTO and to increase the normal force generated by spring <NUM> using actuator <NUM>, as discussed above, to accommodate the transmission of higher force to guide wire <NUM> without slippage.

In another embodiment, catheter procedure system <NUM> may be configured to control the normal force applied to guide wire <NUM> to induce slippage between drive wheel <NUM> and guide wire <NUM> as a mechanism for ensuring the axial force applied to guide wire <NUM> remains below a certain threshold. In this embodiment, the normal force can be controlled to ensure that slippage between drive wheel <NUM> and guide wire <NUM> occurs if guide wire axial motor <NUM> attempts to impart an axial force exceeding the frictional force between drive wheel <NUM> and guide wire <NUM>. In one such embodiment, if high axial speed but low maximum potential axial force is needed, catheter procedure system <NUM> may be configured to control guide wire axial motor <NUM> at a relatively fast rotational speed and to decrease the normal force generated by spring <NUM> using actuator <NUM>, as discussed above. In this mode of operation, if the guide wire encounters an obstacle and guide wire axial motor <NUM> attempts to deliver an axial force greater than the frictional force, drive wheel <NUM> will slip over guide wire <NUM> instead of continuing to push guide wire <NUM> into the obstacle. In one such embodiment, because slippage of this nature is indicative of an obstacle, controller <NUM> may be configured to detect such slippage and to automatically stop guide wire axial drive motor <NUM> to allow the user to evaluate the cause of the obstruction. Further, controller <NUM> may be configured to display a warning message or icon to the user at workstation <NUM> indicating that an obstacle has been encountered.

In various embodiments, controller <NUM> and working catheter axial drive motor <NUM> may be configured to provide for variability and control of the speed and axial force applied to working catheter <NUM> by drive wheel <NUM> during advancement and retraction of working catheter <NUM>. Controller <NUM> and working catheter axial drive mechanism <NUM> may also be configured to provide for variability and control over the normal force applied to working catheter <NUM> by drive wheel <NUM> and roller <NUM> during advancement and retraction of working catheter <NUM>. In one such embodiment, bedside system <NUM> may include a spring force actuator that adjusts the force imparted to roller <NUM> by a spring associated with working catheter axial drive mechanism <NUM>. Variability and control of the axial force applied to working catheter <NUM> may be desirable for various reasons, including lowering the risk of blood vessel perforation, providing improved ability to traverse a partial occlusion or chronic total occlusion (CTO), specific control of different types of working catheters, etc. It should be noted that, while the above disclosure relates primarily to variable control of the forces and speed imparted to a guide wire by guide wire axial drive motor <NUM> and the wheels and springs of the related engagement structures, the same
variable force and speed concepts may be applied to control of working catheter <NUM> and/or working catheter axial drive motor <NUM>.

Claim 1:
A robotic catheter procedure system (<NUM>), comprising:
a bedside system (<NUM>), the bedside system comprising:
a percutaneous device;
a drive mechanism (<NUM>) configured to engage and to impart an axial force to the percutaneous device and to advance and retract the percutaneous device; and
an actuator providing torque to the drive mechanism to impart the axial force to the percutaneous device, wherein the torque provided by the actuator is variable; and
a remote workstation (<NUM>), the remote workstation comprising:
a user interface (<NUM>) configured to receive a first user input; and
a control system (<NUM>) operatively coupled to the user interface, the control system configured to communicate a control signal (<NUM>) to the actuator, the control signal based upon the first user input and a second input, wherein the second input comprises information related the percutaneous device;
wherein the actuator provides torque to the drive mechanism in response to the control signal;
the control system having a high speed axial drive mode being selectable by a user with a third control element in which the maximum speed of the percutaneous device is greater than the maximum speed of the percutaneous device in a regular mode;
the control system limiting availability of the high speed axial drive mode as a function of predetermined parameters related to the information from the second input.