Low friction instrument driver interface for robotic systems

A medical robotic system includes a base having a first opening, and a first protrusion next to the first opening, a first rotary member configured for detachably coupling to a component of the medical robotic system in a manner such that the first rotary member is rotatable relative to the base and at least a part of the first rotary member is located in the first opening of the base when the first rotary member is coupled to the system component, and a cover coupled to the base, wherein the first rotary member comprises a first end, a second end, a body extending between the first and second ends, and a flange disposed circumferentially around a part of the body, the flange having a first circumferential slot for receiving the first protrusion.

INCORPORATION BY REFERENCE

All of the following U.S. patent applications are expressly incorporated by reference herein for all purposes:

FIELD

The application relates generally to robotically controlled surgical systems, and more particularly to flexible instruments and instrument drivers that are responsive to a master controller for performing surgical procedures to treat tissue, such as tissue in the livers.

BACKGROUND

Robotic surgical systems and devices are well suited for use in performing minimally invasive medical procedures, as opposed to conventional techniques wherein the patient's body cavity is open to permit the surgeon's hands access to internal organs. For example, there is a need for a highly controllable yet minimally sized system to facilitate imaging, diagnosis, and treatment of tissues which may lie deep within a patient, and which may be preferably accessed only via naturally-occurring pathways such as blood vessels or the gastrointestinal tract.

In some cases, a robotic surgical system may include a steerable catheter with a steering wire, and an instrument driver for applying tension to the steering wire to steer the catheter. Applicant of the subject application determines that it would be desirable to sense a characteristic that corresponds with an amount of force or torque being applied to pull a steering wire of a robotic surgical system.

SUMMARY

In accordance with some embodiments, a medical robotic system includes a base having a first opening, and a first protrusion next to the first opening, a first rotary member configured for detachably coupling to a component of the medical robotic system in a manner such that the first rotary member is rotatable relative to the base and at least a part of the first rotary member is located in the first opening of the base when the first rotary member is coupled to the system component, and a cover coupled to the base, wherein the first rotary member comprises a first end, a second end, a body extending between the first and second ends, and a flange disposed circumferentially around a part of the body, the flange having a first circumferential slot for receiving the first protrusion.

In accordance with other embodiments, a medical robotic system includes an instrument driver having an actuatable element, a sensor coupled to the instrument driver, and a device configured for detachably coupling to the instrument driver, the device comprising a base having a first opening, and a rotary member configured for detachably coupling to the actuatable element of the instrument driver, wherein the rotary member is rotatable relative to the base, and at least a portion of the rotary member is located within the first opening of the base, wherein when the device is coupled to the instrument driver, the actuatable element is configured to rotate the rotary member in response to a command signal received from a user interface, and wherein the sensor is configured to sense a characteristic that corresponds with an amount of force or torque being applied to the actuatable element in order to rotate the rotary member.

In accordance with other embodiments, a method of steering a distal end of an elongate member includes determining a desired bending to be achieved by the distal end of the elongate member, determining an amount of tension to be applied to a steering wire located within the elongate member based on the desired bending to be achieved, using an actuatable element to apply a torque to turn a rotary member that is detachably coupled to the actuatable element, the steering wire having one end is secured to the rotary member and another end secured to the elongate member, wherein the application of the torque by the actuatable element causes tension to be applied to the steering wire, and using a sensor coupled to the actuatable element to sense a characteristic that corresponds with an amount of force or torque being applied by the actuatable element to turn the rotary member.

Other and further aspects and features will be evident from reading the following detailed description of the embodiments.

DESCRIPTION OF THE EMBODIMENTS

I. Robotic System

Embodiments described herein generally relate to apparatus, systems and methods for robotic surgical systems. A robotic surgical system in which embodiments described herein may be implemented is described with reference toFIGS. 1-10C.

Referring toFIG. 1, a robotically controlled surgical system10in which embodiments of apparatus, system and method may be implemented includes an operator workstation2, an electronics rack6and associated bedside electronics box9, a setup joint or support assembly20(generally referred to as “support assembly”), and a robotic instrument driver16(generally referred to as “instrument driver”). A surgeon is seated at the operator workstation2and can monitor the surgical procedure, patient vitals, and control one or more robotic surgical devices.

Referring toFIG. 2, the instrument driver16, setup joint mounting brace20, and bedside electronics box are shown in greater detail. Referring toFIG. 3, the instrument driver16is illustrated including an elongate member manipulator24and a robotic catheter assembly11installed. The robotic catheter assembly11includes a first or outer robotic steerable complement, otherwise referred to as a sheath instrument30(generally referred to as “sheath” or “sheath instrument”) and/or a second or inner steerable component, otherwise referred to as a robotic catheter or guide or catheter instrument18(generally referred to as “catheter” or “catheter instrument”). The sheath instrument30and catheter instrument18are controllable using the instrument driver16. During use, a patient is positioned on an operating table or surgical bed22(generally referred to as “operating table”) to which the support assembly20, instrument driver16, and robotic catheter assembly11are coupled or mounted.

In the illustrated embodiments, the elongate member manipulator24(generally referred to as “manipulator”) is configured for manipulating an elongate member26. In some embodiments, the elongate member26may be a guidewire. In other embodiments, the elongate member26may be a treatment device (e.g., an ablation catheter) that is configured to deliver energy to treat tissue, such as tissue at a liver. In further embodiments, the elongate member26may be any of other instruments for medical use. During use, at least a part of the elongate member26is disposed within a lumen of the catheter instrument18, and the proximal end of the elongate member26is removably coupled to the manipulator24. In some embodiments, the manipulator24is configured to advance and retract the elongate member26relative to the catheter instrument18. In other embodiments, the manipulator24may also be configured to roll the elongate member26so that it rotates about its longitudinal axis.

Various system components in which embodiments described herein may be implemented are illustrated in close proximity to each other inFIG. 1, but embodiments may also be implemented in systems10in which components are separated from each other, e.g., located in separate rooms. For example, the instrument driver16, operating table22, and bedside electronics box9may be located in the surgical area with the patient, and the operator workstation2and the electronics rack6may be located outside of the surgical area and behind a shielded partition. System10components may also communicate with other system10components via a network to allow for remote surgical procedures during which the surgeon may be located at a different location, e.g., in a different building or at a different hospital utilizing a communication link transfers signals between the operator control station2and the instrument driver16. System10components may also be coupled together via a plurality of cables or other suitable connectors14to provide for data communication, or one or more components may be equipped with wireless communication components to reduce or eliminate cables14. In this manner, a surgeon or other operator may control a surgical instrument while being located away from or remotely from radiation sources, thereby decreasing the operator's exposure to radiation.

Referring toFIG. 4, one example of an operator workstation2that may be used with the system10shown inFIG. 1includes three display screens4, a touch screen user interface5, a control button console or pendant8, and a master input device (MID)12. The MID12and pendant8serve as user interfaces through which the surgeon can control operation of the instrument driver16and attached instruments. By manipulating the pendant8and the MID12, a surgeon or other operator can cause the instrument driver16to remotely control the catheter instrument18and/or the sheath instrument30mounted thereon. Also, in some embodiments, by manipulating one or more controls at the station2, the surgeon or operator may cause the manipulator24to remotely move the elongate member26. A switch7may be provided to disable activity of an instrument temporarily. The console2in the illustrated system10may also be configurable to meet individual user preferences. For example, in the illustrated example, the pendant8and the touch screen5are shown on the left side of the console2, but they may also be relocated to the right side of the console2. Various numbers of display screens may be provided. Additionally or alternatively, a bedside console3may be provided for bedside control of the of the instrument driver16if desired. Further, optional keyboard may be connected to the console2for inputting user data. The workstation2may also be mounted on a set of casters or wheels to allow easy movement of the workstation2from one location to another, e.g., within the operating room or catheter laboratory. Further aspects of examples of suitable MID12, and workstation2arrangements are described in further detail in U.S. patent application Ser. No. 11/481,433, issued as U.S. Pat. No. 8,052,636 on Nov. 8, 2011, and U.S. Provisional Patent Application No. 60/840,331, the contents of which were previously incorporated herein by reference.

As shown inFIG. 1, the support assembly20is configured for supporting or carrying the instrument driver16over the operating table22. One suitable support assembly20has an arcuate shape and is configured to position the instrument driver16above a patient lying on the table22. The support assembly20may be configured to movably support the instrument driver16and to allow convenient access to a desired location relative to the patient. The support assembly20may also be configured to lock the instrument driver16into a certain position.

In the illustrated example, the support assembly20is mounted to an edge of the operating table22such that a catheter and sheath instruments18,30mounted on the instrument driver16can be positioned for insertion into a patient. The instrument driver16is controllable to maneuver the catheter and/or sheath instruments18,30within the patient during a surgical procedure. The distal portion of the setup joint20also includes a control lever33for maneuvering the setup joint20. Although the figures illustrate a single guide catheter18and sheath assembly30mounted on a single instrument driver16, embodiments may be implemented in systems10having other configurations. For example, embodiments may be implemented in systems10that include a plurality of instrument drivers16on which a plurality of catheter/sheath instruments18,30can be controlled. Further aspects of a suitable support assembly20are described in U.S. patent application Ser. No. 11/481,433, issued as U.S. Pat. No. 8,052,636 on Nov. 8, 2011, and U.S. Provisional Patent Application No. 60/879,911, the contents of which are expressly incorporated herein by reference. Referring toFIG. 2, the support assembly20may be mounted to an operating table22using a universal adapter base plate assembly39, similar to those described in detail in U.S. Provisional Patent Application No. 60/899,048, incorporated by reference herein in its entirety. The adapter plate assembly39mounts directly to the operating table22using clamp assemblies, and the support assembly20may be mounted to the adapter plate assembly39. One suitable adapter plate assembly39includes two large, flat main plates which are positioned on top of the operating table22. The assembly39provides for various adjustments to allow it to be mounted to different types of operating tables22. An edge of the adapter plate assembly39may include a rail that mimics the construction of a traditional surgical bedrail. By placing this rail on the adapter plate itself, a user may be assured that the component dimensions provide for proper mounting of the support assembly20. Furthermore, the large, flat surface of the main plate provides stability by distributing the weight of the support assembly20and instrument driver16over an area of the table22, whereas a support assembly20mounted directly to the operating table22rail may cause its entire load to be placed on a limited and less supportive section of the table22. Additionally or alternatively, a bedside rail13may be provided which may couple the support assembly20to the operating table22. The bedside rail may include a leadscrew mechanism which will enable the support assembly to translate linearly along the edge of the bed, resulting in a translation of the instrument driver16and ultimately a translation in the insert direction of the catheter and sheath instruments18/30.

FIGS. 5A-Cillustrate the instrument drive16with various components installed.FIG. 5Aillustrates the instrument driver16with the instrument assembly11installed including the sheath instrument30and the associated guide or catheter instrument18whileFIG. 5Billustrates the instrument driver16without an attached instrument assembly11. The sheath instrument30and the associated guide instrument18are mounted to associated mounting plates37,38on a top portion of the instrument driver16.FIG. 5Cillustrates the instrument driver16with skins removed to illustrate internal components. Embodiments described are similar to those described in detail in U.S. patent application Ser. Nos. 11/678,001, issued as U.S. Pat. No. 8,092,397 on Jan. 10, 2012,11/678,016, issued as U.S. Pat. No. 8,052,621 on Nov. 8, 2011, and 11/804,585, now abandoned, each incorporated by reference herein in its entirety.

Referring toFIGS. 6A-B, the assembly11that includes the sheath instrument30and the guide or catheter instrument18positioned over their respective mounting plates38,37is illustrated removed from the instrument driver16. Additionally a sterile adaptor41can be used to couple each of the sheath and guide instruments to their respective mounting plates. The catheter instrument18includes a guide catheter instrument member61a, and the sheath instrument30includes a sheath instrument member62a. The guide catheter instrument member61ais coaxially interfaced with the sheath instrument member62aby inserting the guide catheter instrument member61ainto a working lumen of the sheath catheter member62a. As shown inFIG. 6A, the sheath instrument30and the guide or catheter instrument18are coaxially disposed for mounting onto the instrument driver16. However, it should be understood that the sheath instrument16may be used without a guide or catheter instrument18, or the guide or catheter instrument18may be used without a sheath instrument30. In such cases, the sheath instrument16or the catheter instrument18may be mounted onto the instrument driver16individually. With the coaxial arrangement as shown inFIG. 6A, a guide catheter splayer61is located proximally relative to, or behind, a sheath splayer62such that the guide catheter member61acan be inserted into and removed from the sheath catheter member61b.

The splayers61,62are configured to steer the members61a,61b, respectively. In the illustrated embodiments, each of the splayers61,62includes drivable elements therein configured to apply tension to different respective wires inside the member61a/61bto thereby steer the distal end of the member61a/61b. In some embodiments, the drivable elements may be actuated in response to a control signal from a controller, which receives an input signal from the work station2, and generates the control signal in response to the input signal. Also, in the illustrated embodiments, the splayers61,62may be translated relative to the instrument driver16. In some embodiments, the instrument driver16may be configured to advance and retract each of the splayers61,62, so that the catheter instrument18and the sheath instrument30may be advanced distally and retracted proximally.

FIGS. 7A and 7Billustrate the sheath splayer62of one embodiment illustrated with the sterile adaptor41and mounting plate38coupled to a portion of the instrument driver shown with only a set of actuation mechanisms that will be described later in detail. As shown inFIG. 6A, the sheath and guide splayers62,61, appear similar physically in construction with the exception of differences in a valve purge tube32. It should be noted that the purge tube32may or may not be included for either the guide or sheath splayer. The sheath splayer62will be described herein. However it should be understood that the guide splayer61is of similar construction, and components of the sheath splayer62can be repeated for the guide splayer61.

As illustrated inFIG. 7C, the splayer62includes a splayer cover72fixably coupled to a splayer base assembly78using four screws79. The splayer base78having four cavities to receive and house pulley assemblies80is used for both the guide splayer61and sheath splayer62. For this embodiment of a sheath splayer62, four cavities of the splayer base78are populated with pulley assemblies80but it should be understood that varying numbers of cavities may be populated leaving remaining cavities open. The guide splayer61may have all its cavities populated with four pulley assemblies80for pulling four respective wires, as can be seen inFIG. 6B. The splayer base78of this implementation can be constructed from injection molded polycarbonate.

During splayer62assembly, the pulley assembly80is put together and mated with a catheter pull wire or control element (not shown). The pull wire (not shown) runs down the length of a catheter from distal to proximal end then is wound about the pulley. By rotating the pulley, the pull wire bends the distal tip of the catheter controlling its bend.

Referring back toFIGS. 6A-6B, when a catheter is prepared for use with an instrument, its splayer is mounted onto its appropriate mounting plate via a sterile adaptor. In this case, the sheath splayer62is placed onto the sheath mounting plate38and the guide splayer61is place onto the guide mounting plate37via sterile adaptors41. Referring toFIG. 7A-B, the pulley assemblies80are configured to couple to floating shafts82on the splayer adaptor41which in turn are configured to couple to sleeve receptacles90. In the illustrated example, each mounting plates37,38has four openings37a,38athat are designed to receive the corresponding floating shafts84attached to and extending from the sterile adaptors41coupled to the splayers61,62. In the example illustrated inFIG. 6B, four floating shafts82of the sterile adaptor41are insertable within the openings38aof the sheath mounting plate38as the splayer62is mounted onto the RCM. Similarly, four floating shafts82of the sterile adaptor41are insertable within the four apertures or openings37aof the guide interface plate37. Referring toFIGS. 7D-E, the coupling of the pulley assemblies80to floating shafts82and floating shafts82to sleeve receptacles90is illustrated.FIG. 7Dillustrates top and bottom perspective views of the pulley assembly80positioned above the floating shaft82where the bottom of the pulley assembly80is configured to mate with splines on the top of the floating shaft82.FIG. 7Eillustrates the floating shaft82installed and un-installed onto the sleeve receptacle90. The sleeve receptacles can include a notch90ashaped to accept a pin84on the floating shaft82.

Referring back toFIGS. 7A-B, the sheath splayer62is shown having latches73which may couple to hooks86. By depressing the latches73, the splayer62may be locked and unlocked to the sterile adaptor41. The sterile adaptor in turn is configured having mounting hooks88which couple to sliding latches77on the mounting plate83. The sliding latches77can be spring loaded to allow the adaptor plate41to be locked to the mounting plate38by applying downward force on the adaptor plate41. The sliding latches can be depressed to release the adaptor plate41when desired.

The sheath interface mounting plate38as illustrated inFIGS. 6A and 6Bis similar to the guide interface mounting plate37, and thus, similar details are not repeated. One difference between the plates37,38may be the shape of the plates. For example, the guide interface plate37includes a narrow, elongated segment, which may be used with, for example, a dither mechanism or the elongate member manipulator24. Both plates37,38include a plurality of openings37a,38ato receive floating shafts82and latches73from sterile adaptors41. The splayers61/62, sterile adaptors41, and mounting plates37/38are all described in greater detail in U.S. patent application Ser. No. 13/173,994, filed on Jun. 30, 2011, issued as U.S. Pat. No. 8,827,948 on Sep. 9, 2014, the entire disclosure of which is expressly incorporated by reference herein.

Referring back toFIG. 5Cthe instrument driver16is illustrated with mounting plates37,38fixably coupled to a guide carriage50, and a sheath drive block40, respectively.FIG. 8illustrates the guide carriage50removed from the instrument driver16coupled to cabling (not shown) and associated guide motors53. The guide carriage50includes a funicular assembly56which is illustrated inFIG. 9. The funicular assembly56includes the four sleeve receptacles90. As previously described, the floating shafts82of the sterile adaptor41first insert through the openings37ain the mounting plate37. They then engage with the sleeve receptacles90

Referring back toFIG. 8, a set of cables (not shown) wound around a set of pulleys52, are coupled on one end to a set of guide motors53and the other end to the sleeve receptacles90. Note that only two of four motors can be seen inFIG. 8. The drive motors53are actuated to rotationally drive the sleeves90. The catheter assembly18with its splayer61mounted onto the instrument drive16would have its pulley assemblies80coupled to corresponding sleeves90via floating shafts82. As the sleeves90are rotated, the pins84of the floating shafts82are seated in the V-shaped notches and are engaged by the rotating sleeves90, thus causing the floating shafts82and associated pulley assemblies80to also rotate. The pulley assemblies80in turn cause the control elements (e.g., wires) coupled thereto to manipulate the distal tip of the catheter instrument30member in response thereto.FIGS. 10A and 10Billustrate top and bottom perspective views of the sheath output plate38exploded from the sheath block40and motor driven interfaces42which are coupled to sheath articulation motors43.FIG. 10Cillustrates sheath articulation motors43coupled to the motor driven interfaces42which includes a set of belts, shafts, and gears which drive receptacle sleeves90(which are similar in construction and functionality to the receptacle sleeves previously described for the guide funicular assembly). When the sheath splayer pulley assemblies80and sterile adaptor floating shafts82are coupled to the receptacle sleeves90, the sheath articulation motors43drive the receptacle sleeves90causing the sheath instrument30to bend in the same manner described for the guide instrument.

During use, the catheter instrument18is inserted within a central lumen of the sheath instrument30such that the instruments18,30are arranged in a coaxial manner as previously described. Although the instruments18,30are arranged coaxially, movement of each instrument18,30can be controlled and manipulated independently. For this purpose, motors within the instrument driver16are controlled such that the drive and sheath carriages coupled to the mounting plates37,38are driven forwards and backwards independently on linear bearings each with leadscrew actuation.FIG. 10illustrates the sheath drive block40removed from the instrument driver coupled to two independently-actuated lead screw45,46mechanisms driven by guide and sheath insert motors47a,47b. Note the guide carriage is not shown. In the illustrated embodiment, the sheath insertion motor47bis coupled to a sheath insert leadscrew46that is designed to move the sheath articulation assembly forwards and backwards, thus sliding a mounted sheath catheter instrument (not shown) forwards and backwards. The insert motion of the guide carriage can be actuated with a similar motorized leadscrew actuation where a guide insert motor47ais coupled to the guide insert leadscrew45via a belt.

Referring back toFIGS. 1, 4 and 6A, in order to accurately steer the robotic sheath62aor guide catheter61afrom an operator work station2, a control structure may be implemented which allows a user to send commands through input devices such as the pendant8or MID12that will result in desired motion of the sheath62aand guide61a. In some embodiments, the sheath62aand/or the guide61amay each have four control wires for bending the instrument in different directions. Referring toFIGS. 11A-H, the basic kinematics of a catheter120with four control elements122a,122b,122c,122dis shown. The catheter120may be component61aor component62ain some embodiments. Referring toFIGS. 11A-B, as tension is placed only upon the bottom control element122c, the catheter bends downward, as shown inFIG. 11A. Similarly, pulling the left control element122dinFIGS. 11C-Dbends the catheter left, pulling the right control element122binFIGS. 11E-Fbends the catheter right, and pulling the top control element122ainFIGS. 11G-Hbends the catheter up. As will be apparent to those skilled in the art, well-known combinations of applied tension about the various control elements results in a variety of bending configurations at the tip of the catheter member120.

The kinematic relationships for many catheter instrument embodiments may be modeled by applying conventional mechanics relationships. In summary, a control-element-steered catheter instrument is controlled through a set of actuated inputs. In a four-control-element catheter instrument, for example, there are two degrees of motion actuation, pitch and yaw, which both have + and − directions. Other motorized tension relationships may drive other instruments, active tensioning, or insertion or roll of the catheter instrument. The relationship between actuated inputs and the catheter's end point position as a function of the actuated inputs is referred to as the “kinematics” of the catheter.

To accurately coordinate and control actuations of various motors within an instrument driver from a remote operator control station such as that depicted inFIG. 1, a computerized control and visualization system may be employed. The control system embodiments that follow are described in reference to a particular control systems interface, namely the SimuLink™ and XPC™ control interfaces available from The Mathworks Inc., and PC-based computerized hardware configurations. However, one of ordinary skilled in the art having the benefit of this disclosure would appreciate that many other control system configurations may be utilized, which may include various pieces of specialized hardware, in place of more flexible software controls running on one or more computer systems.

FIGS. 12-13illustrate examples of a control structure for moving the catheter61aand/or the sheath62ain accordance with some embodiments. In one embodiment, the catheter (or other shapeable instrument) is controlled in an open-loop manner as shown inFIG. 12. In this type of open loop control model, the shape configuration command comes in to the beam mechanics, is translated to beam moments and forces, then is translated to tendon tensions given the actuator geometry, and finally into tendon displacement given the entire deformed geometry.

Referring toFIG. 13, an overview of other embodiment of a control system flow is depicted. A master computer400running master input device software, visualization software, instrument localization software, and software to interface with operator control station buttons and/or switches is depicted. In one embodiment, the master input device software is a proprietary module packaged with an off-the-shelf master input device system, such as the Phantom™ from Sensible Devices Corporation, which is configured to communicate with the Phantom™ hardware at a relatively high frequency as prescribed by the manufacturer. Other suitable master input devices, such as the master input device12depicted inFIG. 2are available from suppliers such as Force Dimension of Lausanne, Switzerland. The master input device12may also have haptics capability to facilitate feedback to the operator, and the software modules pertinent to such functionality may also be operated on the master computer126.

Referring toFIG. 13, in one embodiment, visualization software runs on the master computer126to facilitate real-time driving and navigation of one or more steerable instruments. In one embodiment, visualization software provides an operator at an operator control station, such as that depicted inFIG. 2, with a digitized “dashboard” or “windshield” display to enhance instinctive drivability of the pertinent instrumentation within the pertinent tissue structures. Referring toFIG. 14, a simple illustration is useful to explain one embodiment of a preferred relationship between visualization and navigation with a master input device12. In the depicted embodiment, two display views142,144are shown. One preferably represents a primary142navigation view, and one may represent a secondary144navigation view. To facilitate instinctive operation of the system, it is preferable to have the master input device coordinate system at least approximately synchronized with the coordinate system of at least one of the two views. Further, it is preferable to provide the operator with one or more secondary views which may be helpful in navigating through challenging tissue structure pathways and geometries.

Referring still toFIG. 14, if an operator is attempting to navigate a steerable catheter in order to, for example, contact a particular tissue location with the catheter's distal tip, a useful primary navigation view142may comprise a three dimensional digital model of the pertinent tissue structures146through which the operator is navigating the catheter with the master input device12, along with a representation of the catheter distal tip location148as viewed along the longitudinal axis of the catheter near the distal tip. This embodiment illustrates a representation of a targeted tissue structure location150, which may be desired in addition to the tissue digital model146information. A useful secondary view144, displayed upon a different monitor, in a different window upon the same monitor, or within the same user interface window, for example, comprises an orthogonal view depicting the catheter tip representation148, and also perhaps a catheter body representation152, to facilitate the operator's driving of the catheter tip toward the desired targeted tissue location150.

In one embodiment, subsequent to development and display of a digital model of pertinent tissue structures, an operator may select one primary and at least one secondary view to facilitate navigation of the instrumentation. By selecting which view is a primary view, the user can automatically toggle a master input device12coordinate system to synchronize with the selected primary view. In an embodiment with the leftmost depicted view142selected as the primary view, to navigate toward the targeted tissue site150, the operator should manipulate the master input device12forward, to the right, and down. The right view will provide valued navigation information, but will not be as instinctive from a “driving” perspective.

To illustrate: if the operator wishes to insert the catheter tip toward the targeted tissue site150watching only the rightmost view144without the master input device12coordinate system synchronized with such view, the operator would have to remember that pushing straight ahead on the master input device will make the distal tip representation148move to the right on the rightmost display144. Should the operator decide to toggle the system to use the rightmost view144as the primary navigation view, the coordinate system of the master input device12is then synchronized with that of the rightmost view144, enabling the operator to move the catheter tip148closer to the desired targeted tissue location150by manipulating the master input device12down and to the right. The synchronization of coordinate systems may be conducted using fairly conventional mathematic relationships which are described in detail in the aforementioned applications incorporated by reference.

Referring back to embodiment ofFIG. 13, the master computer126also comprises software and hardware interfaces to operator control station buttons, switches, and other input devices which may be utilized, for example, to “freeze” the system by functionally disengaging the master input device as a controls input, or provide toggling between various scaling ratios desired by the operator for manipulated inputs at the master input device12. The master computer126has two separate functional connections with the control and instrument driver computer128: one connection132for passing controls and visualization related commands, such as desired XYZ (in the catheter coordinate system) commands, and one connection134for passing safety signal commands. Similarly, the control and instrument driver computer128has two separate functional connections with the instrument and instrument driver hardware130: one connection136for passing control and visualization related commands such as required-torque-related voltages to the amplifiers to drive the motors and encoders, and one connection138for passing safety signal commands. Also shown in the signal flow overview ofFIG. 13is a pathway140between the physical instrument and instrument driver hardware130back to the master computer126to depict a closed loop system embodiment wherein instrument localization technology is utilized to determine the actual position of the instrument to minimize navigation and control error.

As discussed with reference toFIGS. 6-7, the robotic system10includes an instrument driver (or drive assembly)16with sleeve receptacles90for turning the respective shafts82at the sterile adaptor41, which in turn, rotates the respective pulley assemblies80at the splayer61/62. In some embodiments, the robotic system10may further include a sensor for sensing a characteristic that corresponds with an amount of force or torque being applied to turn the sleeve receptacles90.FIG. 15illustrates some components of the robotic system10that includes tension sensing capability in accordance with some embodiments. As shown in the figure, the instrument driver16includes the sleeve receptacles90, which are actuatable elements that are actuated by respective motors200. The instrument driver16also includes sensors202coupled to the respective motors200. Each sensor202is configured to sense a characteristic that corresponds with an amount of force or torque being applied to the actuatable element90. The sensor202is illustrated schematically as being coupled to the motor200. In some embodiments, the sensor202may be located internally inside a motor. In other embodiments, the sensor202may be secured to an exterior of a motor. In other embodiments, the sensor202may be attached to a component that is coupled to the motor. For example, in some embodiments, the motor200may be mounted to a ring structure (like the ring structure300shown inFIG. 19) that is attached to the instrument driver16. In such cases, the sensor202may be attached to the ring structure, and the sensor202may be considered as being coupled to the motor200(indirectly, in this example).

The robotic system10also includes the sterile adaptor41, which has a base220with a plurality of openings224for housing respective rotary members82. In the illustrated embodiments, the rotary members82are shafts configured for detachably coupling to respective sleeve receptacles90. In particular, each rotary member82has a first end210for insertion into the sleeve receptacle90, a second end212, and a body214extending between the first and second ends210,212. The sterile adaptor41also includes a cover222that is coupled to the base220, and a flexible sheet (membrane)226for providing a sterile barrier so that after the splayer assembly61/62is used, the sterile adaptor41and the splayer assembly61/62may be discarded, while leaving the instrument driver16sterile.

The robotic system10also includes the splayer61/62, which includes a base78with a plurality of openings230for housing respective pulley assemblies80, and a cover72for coupling to the base78. When the cover72is coupled to the base78, it covers the pulley assemblies80. The splayer61/62also includes an elongate member61a/62acoupled to the base78(e.g., either directly to the base78, or indirectly to the base78through the cover72). The elongate member61a/62amay be a catheter, a sheath, or any elongate instrument having a lumen extending therethrough. The robotic system10also includes a plurality of steering wires204disposed in the elongate member61a/62a. Each steering wire204has a distal end coupled to a distal end of the elongate member, and a proximal end coupled to one of the pulley assemblies80. During use, the pulley assembly may be rotated to apply tension to the steering wire204to thereby apply tension to the steering wire204, which in turn, causes the distal end of the elongate member61a/62ato bend. Although two pulley assemblies80are shown, it should be understood that in other embodiments, the splayer61/62may have more than two pulley assemblies80(e.g., four pulley assemblies80), with respective steering wires204connected thereto. Also, in other embodiments, the splayer61/62may have only one pulley assembly80, and the elongate member61a/62amay have only one steering wire204connected to the pulley assembly80.

As shown in the figure, the actuatable element90is configured to turn the pulley assembly80indirectly through the rotary member82at the sterile adaptor41to thereby apply tension to the steering wire204at the catheter61a/sheath62a. The sensor202is configured to sense a characteristic that corresponds with an amount of force being applied to the actuatable element90. By means of non-limiting examples, the characteristic may be an actual force, a torque (which is force times distance), a strain, a stress, an acceleration, etc. The sensed characteristic may be used to correlate an amount of tension being applied to the steering wire204. In some embodiments, the sensed characteristic may be transmitted from the sensor202to the user interface2, and the value of the sensed characteristic may be displayed on a screen for presentation to a user. Also, in some embodiments, the sensed characteristic may be transmitted from the sensor202in a form of a signal to a processor, which processes the signal, and controls an amount of torque/force being applied to the motor200in response to the processed signal.

In some embodiments, in order to accurately correlate the sensed characteristic by the sensor202with an amount of tension being applied at the steering wire204, it may be desirable to minimize, or at least reduce an amount of friction between the shaft82and the base220at the sterile adaptor41. In the illustrated embodiments, the sterile adaptor41includes an interface between each rotary member82and the base220for reducing an amount of friction therebetween (i.e., between the shaft body214of the rotary member82and the wall in the opening224defined by the base220). As shown in the figure, each rotary member82includes a flange240disposed circumferentially around the shaft body214, and a plurality of slots242at the flange240. Two slots242are shown, which are defined by a partition244extending round the shaft body214of the rotary member82. The partition244may have a ring configuration. For example, the partition244may have a continuous ring structure, or alternatively, a plurality of structures that form a ring configuration. Each slot242has a ring configuration that extends around the shaft body214of the rotary member82. Also, as shown in the figure, the base220includes a protrusion246next to (e.g., within 5 cm or less from) the opening224. The protrusion246has a ring configuration around the opening224, and extends into a slot242. For example, the protrusion246may have a continuous ring structure, or alternatively, may have a plurality of structures that form into a ring configuration. Although one protrusion246is shown in the example, in other embodiments, the sterile adaptor41may include a plurality of protrusions246that extend into respective ones of the slots242at the flange240. Also, in other embodiments, the flange240of the rotary member82may include more than two slots242, or less than two slots242(e.g., only one slot242).

In the illustrated embodiments, the cross sectional dimension of the shaft body214is less than the cross sectional dimension of the opening224(e.g., by 3 mm, and more preferably by 2 mm, and even more preferably by 1 mm or less). The partition(s)244at the flange240and the protrusion(s)246at the base220cooperate with each other (e.g., engage with each other) to prevent the shaft214from touching the surrounding wall at the opening224. Accordingly, the shaft body214essentially “floats” within the space defined by the opening224. In the illustrated embodiments, the partition244abuts against the protrusion246while the shaft body214is maintained within the opening224so that it is spaced away from the wall of the opening224. In other embodiments, the partition244may not abut against the protrusion246. Instead, there may be a small gap between the partition244and the protrusion246to reduce friction between the partition244and the protrusion246. The gap may be large enough to allow some movement of the shaft body214relative to the base220, while small enough to prevent the shaft body214from touching the wall at the opening224.

In some embodiments, to further provide a frictionless interface, the partition(s)244and/or the protrusion(s)246may be coated with a hydrophobic material to allow fluid to glide easily along the surfaces of these components. Also, in some embodiments, a lubricant, such as oil, may be applied to the surface of the partition(s)244and/or the protrusion(s)246.

During use, the sterile adaptor41is detachably coupled to the instrument driver16. Such may be accomplished by inserting the first ends210of the respective rotary members82into respective openings at the acutatable elements90(like that shown inFIG. 7E). The membrane226provides a barrier to prevent the instrument driver16from being contaminated during a medical procedure. Also, during use, the splayer61is detachably coupled to the sterile adaptor41. Such may be accomplished by inserting the second ends212of the respective rotary members82into respective openings at the end of the rotary members80(like that shown inFIG. 7D).

The same setup may be performed for the splayer62. In particular, during use, another sterile adaptor41is detachably coupled to the instrument driver16. Such may be accomplished by inserting the first ends210of the respective rotary members82into respective openings at the acutatable elements90(like that shown inFIG. 7E). Also, the splayer62is detachably coupled to the sterile adaptor41. Such may be accomplished by inserting the second ends212of the respective rotary members82into respective openings at the end of the rotary members80(like that shown inFIG. 7D).

After the splayers61,62are mounted to respective sterile adaptors41, and after the sterile adaptors41are mounted to the instrument driver16, the robotic system10may then be used to perform a medical procedure. For example, in some embodiments, the splayer61and/or splayer62may be controlled to position the catheter61aand/or the sheath62aat desired position(s) within the patient. Once the catheter61aand/or the sheath62ahave been desirably positioned, the catheter61aand/or the sheath62amay then be used to deliver an instrument (e.g., an ablation device) or a substance (e.g., occlusive device, drug, etc.) to treat the patient.

Various techniques may be employed to move the catheter61aand/or the sheath62ato thereby place these instruments at desired positions(s) in the patient. In some embodiments, the instrument driver16may be configured to translate the splayer61to thereby translate the catheter61ain an axial direction. Also, the instrument driver16may be configured to translate the splayer62to thereby translate the sheath62ain an axial direction. Thus, by moving the splayer61and/or splayer62, the instrument driver16may advance or retract the catheter61arelative to the sheath62a, and vice versa. Also, if the movements of the splayers61,62are synchronized, both the catheter61aand the sheath62amay be moved by the same amount in some embodiments. In some embodiments, the translation of the splayer61and/or the splayer62may be performed by the instrument driver16in response to a command signal received from the user interface. For example, in some embodiments, the instrument driver16may be configured to receive a command signal input from a user at the user interface, and generate a control signal in response to the command signal to move one or both of the splayers61,62.

Also, in some embodiments, the instrument driver16may be configured to bend a distal end of the catheter61a, a distal end of the sheath62a, or both. For example, in some embodiments, the instrument driver16may actuate one or more motors at the instrument driver16to turn one or more respective actuatable elements90, thereby turning one or more respective rotary members80at the splayer61indirectly through the one or more respective rotary members82at the sterile adaptor41. The turning of the one or more rotary members80at the splayer61applies tension to one or more respective steering wires to thereby bend the catheter61atowards a certain direction.

Similarly, in some embodiments, the instrument driver16may actuate one or more motors at the instrument driver16to turn one or more respective actuatable elements90, thereby turning one or more respective rotary members80at the splayer62indirectly through the one or more respective rotary members82at the sterile adaptor41. The turning of the one or more rotary members80at the splayer62applies tension to one or more respective steering wires to thereby bend the sheath62atowards a certain direction.

In some embodiments, as the rotary member80is being turned to apply tension to the steering wire204, the sensor202senses a characteristic that correlates with an amount of force or torque being applied by the actuatable element90. For example, in some embodiments, the sensor202may be a torque sensor configured to measure an amount of torque being applied to the actuatable element90. The measured torque may be divided by a moment arm (e.g., a radius of the actuatable element90) to derive a force value. In some embodiments, the force value may correlate with an amount of tension being applied to the steering wire204. For example, in some cases, the force value may be considered to be the amount of tension being applied to the steering wire204. In other embodiments, the sensor202may be a force sensor configured to measure a force vector that is in opposite direction as the tension force at the steering wire204. Because of the frictionless interface at the sterile adaptor41, the force sensed by the sensor202may be substantially equal to (e.g., at least 80%, and more preferably at least 90%, and even more preferably at least 99% of) the amount of tension at the steering wire204.

In some embodiments, the sensed characteristic by the sensor202may be used in a process to steer the distal end of the catheter61a/sheath62aso that the distal end achieves a desired amount of bending. For example, in some embodiments, in a method of steering the distal end of the catheter61a/sheath62a(elongate member), an amount of bending to be achieved by the distal end of the elongate member may first be determined. Such may be accomplished by a user of the system10. Alternatively, such may be accomplished automatically by a processor based on an anatomy of the patient, and the location of the elongate member61a/62a. Next, an amount of tension to be applied to the steering wire204located within the elongate member61a/62amay be determined based on the amount of bending that is desired to be achieved. In general, the more tension is being applied to the steering wire204, the more the amount of bending will be achieved at the distal end of the elongate member61a/62a. In some embodiments, the amount of tension may be calculated automatically by the processor based on structural properties (e.g., bending stiffness) of the elongate member61a/62a. Next, the instrument driver16actuates the actuatable element90to apply a torque to turn the rotary member80that is detachably coupled (directly or indirectly through element82) to the actuatable element90. The application of the torque by the actuatable element90causes tension to be applied to the steering wire204. While the actuatable element90is being actuated, the sensor202senses a characteristic that corresponds with an amount of force or torque being applied by the actuatable element90to turn the rotary member80. In the illustrated embodiments, the act of using the actuatable element90to apply the torque comprises increasing the amount of force or torque being applied by the actuatable element90until the sensed characteristic by the sensor202indicates that the determined amount of tension at the steering wire204has been achieved. The above technique for bending the elongate member61a/62ais advantageous because it obviates the need to determine how much axial movement (e.g., due to axial strain of the steering wire204, and relative movement between the steering wire204and the elongate member61a/62a) needs to be achieved by the steering wire204in order to achieve a certain desired amount of bending. In particular, the above technique involving use of the sensor202is advantageous over another technique of achieving a desired amount of bending, which involve determining how much tension is needed at the steering wire204, and then determining a required amount of axial movement by the steering wire204that corresponds with the determined tension. Then the system monitors an amount of axial movement by the steering wire204until the required amount of axial movement by the steering wire204is achieved. However, calculating the required amount of axial movement needs to be achieved by the steering wire based on the required tension may be difficult, computational intensive, and may not be accurate.

Also as illustrated in the above embodiments, the frictionless interface at the sterile adaptor41is advantageous because it significantly remove all or most of the friction between the rotary member82and its surrounding wall in the opening224. Thus, the frictionless interface at the sterile adaptor41is preferred over rubber seal, and the robotic system10does not include any rubber seal between the rotary member82and the base220of the sterile adaptor41.

In the above embodiments, the rotary member80at the splayer61/62has been described as having an opening at one end of the rotary member80for receiving the second end212of the rotary member82at the sterile adaptor41. In other embodiments, the configuration of the coupling may be reversed. For example, in other embodiments, the rotary member80at the splayer61/62may have an end for insertion into an opening at the second end212of the rotary member82at the sterile adaptor41(FIG. 16).

Also, in the above embodiments, the first end210of the rotary member82at the sterile adaptor41has been described as being inserted into an opening at the actuatable element90at the instrument driver16. In other embodiments, the configuration of the coupling may be reversed. For example, in other embodiments, the first end210of the rotary member82at the sterile adaptor41may have an opening for receiving an end of the actuatable element90at the instrument driver16(FIG. 17). Furthermore, in other embodiments, the second end212of the rotary member82in the embodiments ofFIG. 17may be configured for insertion into an opening at the end of the rotary member80(like that shown inFIG. 15).

In the above embodiments, the frictionless interface at the sterile adaptor41includes two slots242and a protrusion246inserted into one of the slots242. In other embodiments, the frictionless interface may include an additional protrusion246extending into the second slot242. Also, in further embodiments, the frictionless interface may include only one slot242(FIG. 18).

As discussed, the sensor202is coupled to the motor200, either directly or indirectly. Various techniques may be employed for coupling the sensor202to the motor200. In some embodiments, the sensor202may be a strain gauge mounted to an output shaft. In other embodiments, the sensor202may be a torque sensor mounted in series with the output shaft.

In further embodiments, the motor200(with optional gearbox) may be mounted to the instrument driver16(e.g., to a chassis of the instrument driver) through a mounting structure300(FIG. 19). In such cases, the sensor202may be attached to the mounting structure300. Such configuration is advantageous because it allows torque to be measured at the output shaft by measuring the reaction forces from the entire gear train. This is because at static equilibrium, the measured reaction torque may be equal to the output shaft torque. The mounting structure300has a ring configuration in some embodiments. In other embodiments, the mounting structure300may have other configurations. Also, in some embodiments, the mounting structure300may be considered to be a part of the sensor202. The sensor202(and optionally with the mounting structure300) may be a torque sensor, a hinge or flexure based structure with integrated load cell(s) or strain gauge(s), or a strain gauge mounted to an otherwise rigid mounting structure.

In some cases, the sensor202may pick up inertial forces from the acceleration and deceleration of the motor200. Options for minimizing this contamination include (1) low-pass filtering the measured signal, (2) using only data collected when the motor200is stationary or moving at an approximately constant velocity, and/or (3) modeling the inertial effects of the motor200, and compensating the measured signal based upon a measured acceleration by an encoder at the motor200and/or motor back-EMF.

In other embodiments, by mounting the axis of the motor200at 90° relative to the axis of the output shaft, the inertia forces due to acceleration and deceleration of the motor200will be decoupled from the measured reaction torque (FIG. 20). As shown in the figure the robotic system10may optionally further include a gear box310for transmitting torque from the motor200to the output shaft that is axially aligned with the actuatable element90. In such cases, the acceleration of the output shaft, pulley, etc., may still contaminate the measurement of wire tension, but these contributions will be relatively small compared to the acceleration of the motor rotor, especially because of the effects of gear reduction between motor and output shaft. The sensor202(and optionally with the mounting structure300) may be a torque sensor, a hinge or flexure based structure with integrated load cell(s) or strain gauge(s), or a strain gauge mounted to an otherwise rigid mounting structure.

In further embodiments, the instrument driver16may include a differential gearbox320mechanically coupled to the motor200(FIG. 21). The gearbox320is configured to turn a first output shaft322that is coupled to the actuatable element90, while a second output shaft324extending from the gearbox320is fixed to the instrument driver16(e.g., to a chassis of the instrument driver16). In some embodiments, the second output shaft324may be fixed to the instrument driver16through the sensor202(see option A in figure), which may be a torque sensing element in some embodiments. Alternatively, the second output shaft324may be fixed to the instrument driver16without using the sensor202, in which cases, the sensor202(which may be a strain gauge in some embodiments) may be secured to the second output shaft324(see option B in figure). The gearbox320is advantageous because it allows the sensor202to be coupled to a component that experiences torque from the gearbox320, but does not spin (which is beneficial because it obviates the need to implement complicated signal connection, such as a slip connection, that may otherwise be needed if the sensor202is coupled to a spinning shaft). In some embodiments, the gearbox320may be similar to that used in transferring power to both wheels of an automobile while allowing them to rotate at different speeds. In some cases, the difference between the torque in the upper and lower output shafts322,324may be due to inefficiencies of the differential gearbox320. In such cases, by maximizing the efficiency of the differential gearbox320, the sensor202may provide a good estimate of the pullwire tension without having to deal with routing signal connections to a sensor that is moving. Also, in some embodiments, the configuration of the embodiments shown inFIG. 21may be simplified by incorporating the secondary (fixed) output shaft324and the sensor202entirely within a housing of the differential gearbox320. This may provide for a compact gearbox with integrated output shaft torque sensing and no limitations on output shaft motion.

III. Driving Modes

As discussed, the system10may be configured to move the sheath62adistally or proximally, move the catheter61adistally or proximally, and to move the elongate member26distally or proximally. In some cases, the movement of the sheath62amay be relative to the catheter61a, while the catheter61aremains stationary. In other cases, the movement of the catheter61amay be relative to the sheath62awhile the sheath62aremains stationary. Also, in other cases, the sheath62aand the catheter61amay be moved together as a unit. The elongate member26may be moved relative to the sheath62aand/or the catheter61a. Alternatively, the elongate member26may be moved together with the sheath62aand/or the catheter61a.

In some embodiments, the workstation2is configured to provide some or all of the following commanded motions (driving modes) for allowing the physician to choose. In some embodiments, each of the driving modes may have a corresponding button at the workstation2and/or the bedside control402.

Elongate member Insert—When this button/command is selected, the manipulator24inserts the elongate member26at a constant velocity.

Elongate member Roll—When this button/command is selected, the manipulator24rolls the elongate member26at a constant angular velocity

Elongate member Size—When the size or gauge of the elongate member26is inputted into through the user interface, the system will automatically alter roll and insert actuation at the proximal end of the elongate member26accordingly to achieve desired commanded results. In one implementation, when a user inputs the elongate member's size, the system automatically changes its kinematic model for driving that elongate member26. So if the user commands the elongate member26to move to a certain position, the system will calculate, based on the kinematic model, roll and insert commands, which may be different for different elongate member sizes (e.g., elongate members26with different diameters). By inputting the elongate member's size, the system knows which kinematic model to use to perform the calculation. Such feature is beneficial because different sized elongate members26behave differently.

Leader/Sheath Select—When this button/command is selected, it allows the user to select which device (e.g., catheter61a, sheath62a, elongate member26, or any combination of the foregoing) is active.

Leader/Sheath Insert/Retract—When this button/command is selected, the instrument driver assembly inserts or retracts the catheter61a/sheath62awhile holding the elongate member26and any non-active device fixed relative to the patient. When this motion causes the protruding section of the catheter61ato approach zero (due to insertion of the sheath62aor retraction of the catheter61a), the system automatically relaxes the catheter61aas part of the motion.

Leader/Sheath Bend—When this button/command is selected, the instrument driver assembly bends the articulating portion of the catheter61a/sheath62awithin its currently commanded articulation plane.

Leader/Sheath Roll—When this button/command is selected, the instrument driver assembly uses the pullwires to “sweep” the articulation plane of the device (catheter61aand/or sheath62a) around in a circle through bending action of the device. Thus, this mode of operation does not result in a true “roll” of the device in that the shaft of the device does not roll. In other embodiments, the shaft of the device may be configured to rotate to result in a true roll. Thus, as used in this specification, the term “roll” may refer to an artificial roll created by seeping a bent section, or may refer to a true roll created by rotating the device.

Leader/Sheath Relax—When this button/command is selected, the instrument driver assembly gradually releases tension off of the pullwires on the catheter61a/sheath62a. If in free space, this results in the device returning to a straight configuration. If constrained in an anatomy, this results in relaxing the device such that it can most easily conform to the anatomy.

Elongate Member Lock—When this button/command is selected, the elongate member26position is locked to the catheter61aposition. As the leader is articulated or inserted, the elongate member26moves with the catheter61aas one unit.

System Advance/Retract—When this button/command is selected, the instrument driver assembly advances/retracts the catheter61aand sheath62atogether as one unit. The elongate member26is controlled to remain fixed relative to the patient.

Autoretract—When this button/command is selected, the instrument driver assembly starts by relaxing and retracting the catheter61ainto the sheath62a, and then continues by relaxing and retracting the sheath62awith the catheter61ainside it. The elongate member26is controlled to remain fixed relative to the patient.

Initialize Catheter—When this button/command is selected, the system confirms that the catheter61aand/or the sheath62ahas been properly installed on the instrument driver assembly, and initiates pretensioning. Pretensioning is a process used to find offsets for each pullwire to account for manufacturing tolerances and the initial shape of the shaft of the catheter61aand/or the sheath62a.

Leader/Sheath Re-calibration—When this button/command is selected, the instrument driver assembly re-pretensions the catheter61aand/or the sheath62ain its current position. This gives the system the opportunity to find new pretension offsets for each pullwire and can improve catheter driving in situations where the proximal shaft of the catheter61ahas been placed into a significant bend. It is activated by holding a relax button down for several seconds which ensures that the device is fully de-articulated. Alternatively the re-calibration may be activated without holding down the relax button to de-articulate the device.

Leader Relax Remove—When this button/command is selected, the instrument driver assembly initiates a catheter removal sequence where the catheter61ais fully retracted into the sheath62a, all tension is released from the pullwires, and the splayer shafts (at the drivable assembly61and/or drivable assembly62) are driven back to their original install positions so that the catheter61acan be reinstalled at a later time.

Leader Yank Remove—When this button/command is selected, the instrument driver assembly initiates a catheter removal sequence where the catheter61ais removed manually.

Emergency Stop—When this button/command is selected, the instrument driver assembly initiates a gradual (e.g., 3 second) relaxation of both the catheter61aand the sheath62a. The components (e.g., amplifier) for operating the catheter61a, elongate member26, or another device are placed into a “safe-idle” mode which guarantees that no power is available to the motors that drive these elements, thereby bringing them rapidly to a stop, and allowing them to be manually back-driven by the user. Upon release of the emergency stop button, the system ensures that the catheter61ais still in its allowable workspace and then returns to a normal driving state.

Segment control: In some embodiments, the workstation2allows a user to select individual segment(s) of a multi-segment catheters (such as the combination of the catheter61aand the sheath62a), and control each one. The advantage of controlling the catheter in this way is that it allows for many options of how to control the movement of the catheter, which may result in the most desirable catheter performance. To execute this method of catheter steering, the user selects a segment of the catheter to control. Each segment may be telescoping or non-telescoping. The user may then control the selected segment by bending and inserting it using the workstation2to control the position of the end point of the catheter. Other segment(s) of the catheter will either maintain their previous position (if it is proximal of the selected section) or maintain its previous configuration with respect to the selected section (if it is distal of that section) (FIG. 22A).

Follow mode: In some embodiments, the workstation2allows the user to control any telescoping section while the more proximal section(s) follows behind automatically. This has the advantage of allowing the user to focus mostly on the movement of a section of interest while it remains supported proximally. To execute this method of catheter steering, the user first selects a telescoping section of the elongate instrument (e.g., catheter61aand sheath62a) to control. This section is then controlled using the workstation2to prescribe a location of the endpoint of the segment. Any segment(s) distal of the section of interest will maintain their previous configuration with respect to that section. When the button on the workstation2is released, any segment(s) proximal of the section of interest will follow the path of the selected section as closely as possible until a predefined amount of the selected section remains (FIG. 22B). As an alternative to this driving mode, the segment(s) of the elongate instrument which is proximal of the section of interest could follow along as that segment is moved instead of waiting for the button to be released. Furthermore, with either of these automatic follow options, the system may optionally be configured to re-pretension the sections that have been driven out and re-align the sections that are proximal of the driven section.

Follow mode may be desirable to use to bring the more proximal segments of the elongate instrument towards the tip to provide additional support to the distal segment. In cases where there are three or more controllable sections of the elongate instrument, there are several options for how to execute a “follow” command. Consider the example inFIG. 22Dwhere the distal segment (which may be a guidewire or a steerable instrument in some embodiments) has been driven out as shown in frame 1. The “follow” command could be executed by articulating and/or inserting only the middle segment (which may be the catheter61ain some embodiments) of the elongate instrument as shown in frame 2. The “follow” command could be executed by articulating and/or inserting only the most proximal segment (which may be the sheath62ain some embodiments) of the elongate instrument as shown in frame 3. The “follow” command could also be executed by coordinating the articulation and/or insertion of multiple proximal segments of the elongate instrument as shown in frame 4. Combining the motion of multiple sections has several potential advantages. First, it increases the total degrees-of-freedom available to the algorithm that tries to fit the shape of the following section(s) to the existing shape of the segment being followed. Also, in comparison to following each segment sequentially, a multi-segment follow mode simplifies and/or speeds up the workflow. In addition, multi-segment increases the distance that can be followed compared to when only one proximal segment is used to follow the distal segment.

Mix-and-match mode: In some embodiments, the workstation2allows the user to have the option of mixing and matching between articulating and inserting various sections of a catheter. For example, consider the illustration inFIG. 22C, and assuming that the distal most section of the elongate instrument is the “active” segment. If the user commands a motion of the tip of the elongate instrument as indicated by the arrow in Frame 1, there are several options available for how to achieve this command: (1) Articulate and extend the “active” segment, which is illustrated in frame 3 and is likely considered the normal or expected behavior; (2) Articulate the active distal most segment and insert one of the other proximal segments, as illustrated in frames 2 and 4; (3) Articulate the active distal most segment and combine inserting motion of some or all of the segments, as illustrated in frame 5.

There are multiple potential reasons why the user might want to choose some of these options. First, by “borrowing” insert motion from other segments, some of the segments could be constructed with fixed lengths. This reduces the need for segments to telescope inside of each other, and therefore reduces the overall wall thickness. It also reduces the number of insertion degrees-of-freedom needed. Also, by combining the insert motion from several segments, the effective insert range-of-motion for an individual segment can be maximized. In a constrained space such as the vasculature, the operator may likely be interested in “steering” the most distal section while having as much effective insertion range as possible. It would simplify and speed up the workflow to not have to stop and follow with the other segments.

In other embodiments, the “follow” mode may be carried out using a robotic system that includes a flexible elongated member (e.g., a guidewire), a first member (e.g., the catheter61a) disposed around the flexible elongated member, and a second member (e.g., the sheath62a) disposed around the first member. The flexible elongated member may have a preformed (e.g., pre-bent) configuration. In some embodiments, the flexible elongated member may be positioned inside a body. Such may be accomplished using a drive mechanism that is configured to position (e.g., advance, retract, rotate, etc.) the flexible elongated member. In one example, the positioning of the flexible elongated member comprises advancing the flexible elongated member so that its distal end passes through an opening in the body.

Next, the first member is relaxed so that it has sufficient flexibility that will allow the first member to be guided by the flexible elongated member (that is relatively more rigid than the relaxed first member). In some embodiments, the relaxing of the first member may be accomplished by releasing tension in wires that are inside the first member, wherein the wires are configured to bend the first member or to maintain the first member in a bent configuration. After the first member is relaxed, the first member may then be advanced distally relative to the flexible elongated member. The flexible elongated member, while being flexible, has sufficient rigidity to guide the relaxed first member as the first member is advanced over it. The first member may be advanced until its distal end also passes through the opening in the body.

In some embodiments, the second member may also be relaxed so that it has sufficient flexibility that will allow the second member to be guided by the flexible elongated member (that is relatively more rigid than the relaxed second member), and/or by the first member. In some embodiments, the relaxing of the second member may be accomplished by releasing tension in wires that are inside the second member, wherein the wires are configured to bend the second member or to maintain the second member in a bent configuration. After the second member is relaxed, the second member may then be advanced distally relative to the flexible elongated member. The flexible elongated member, while being flexible, has sufficient rigidity to guide the relaxed second member as the second member is advanced over it. The second member may be advanced until its distal end also passes through the opening in the body. In other embodiments, instead of advancing the second member after the first member, both the first member and the second member may be advanced simultaneously (e.g., using a drive mechanism) so that they move together as a unit. In further embodiments, the acts of advancing the flexible elongated member, the first member, and the second member may be repeated until a distal end of the flexible elongated member, the first member, or the second member has passed through an opening in a body.

In the above embodiments, tension in pull wires in the second elongated member is released to make it more flexible than the first elongated member, and the second elongated member is then advanced over the first elongated member while allowing the first elongated member to guide the second elongated member. In other embodiments, the tension in the pull wires in the first elongated member may be released to make it more flexible than the second elongated member. In such cases, the more flexible first elongated member may then be advanced inside the more rigid second elongated member, thereby allowing the shape of the second elongated member to guide the advancement of the first elongated member. In either case, the more rigid elongated member may be locked into shape by maintaining the tension in the pull wires.

In some of the embodiments described herein, the flexible elongated member may be a guidewire, wherein the guidewire may have a circular cross section, or any of other cross-sectional shapes. Also, in other embodiments, the guidewire may have a tubular configuration. In still other embodiments, instead of a guidewire, the flexible elongated member may be the member26. In further embodiments, the robotic system may further include a mechanism for controlling and/or maintaining the preformed configuration of the guidewire. In some embodiments, such mechanism may include one or more steering wires coupled to a distal end of the guidewire. In other embodiments, such mechanism may be the catheter61a, the sheath62a, or both. In particular, one or both of the catheter61aand the sheath62amay be stiffened (e.g., by applying tension to one or more wires inside the catheter61aand/or the sheath62a). The stiffened catheter61aand/or the sheath62amay then be used to provide support for the guidewire.

Also, in some of the embodiments described herein, any movement of the elongate member26, the catheter61a, and/or the sheath62amay be accomplished robotically using a drive assembly. In some embodiments, the drive assembly is configured to receive a control signal from a processor, and actuate one or more driveable elements to move the elongate member26, the catheter61a, and/or the sheath62a.

It should be noted that the driving modes for the system are not limited to the examples discussed, and that the system may provide other driving modes in other embodiments.

IV. Treatment Methods

FIGS. 23A-23Fillustrate a method of treating tissue using the robotic system10in accordance with some embodiments. As an example, the method will be described with reference to treating liver tissue. However, it should be understood that the system10may be used to treat other types of tissue.

First, the robotic system10is setup by placing the catheter61into the lumen of the sheath62, and by placing the elongate member26into the lumen of the catheter61. Next, an incision is then made at a patient's skin, and the distal end of the catheter61is then inserted into the patient through the incision. In particular, the distal end of the catheter61is placed inside a vessel2000(e.g., a vein or an artery) of the patient. In some embodiments, the liver may be accessed from the femoral vein or femoral artery from either groin. In other embodiments, the liver may be accessed from the right sub-clavin in vein or the right jugular vein. In some embodiments, the initial insertion of the catheter61into the patient may be performed manually. In other embodiments, the initial insertion of the catheter61may be performed robotically using the system10. In such cases, the user may enter a command at the workstation2, which then generates a user signal in response thereto. The user signal is transmitted to a controller, which then generates a control signal in response to the user signal. The control signal is transmitted to the driver to drive the catheter61so that it advances distally into the patient. In some embodiments, while the catheter61is being inserted into the patient, the distal end2300of the elongate member26may be housed within the lumen of the catheter61. In other embodiments, the distal end2300of the elongate member26may extend out of the lumen of the catheter61(which the flexible section320of the elongate member26is housed within the lumen of the catheter61) as the catheter61is being inserted. In such cases, the sharp distal tip of the elongate member26may facilitate insertion through the patient's skin. In other embodiments, the tip of the elongate member26may not be sharp enough, or the distal section of the elongate member26may not be stiff enough, to puncture the patient's skin. In such cases, a separate tool may be used to create an incision at the patient's skin first, as discussed.

In some embodiments, after the catheter61ais placed inside the patient, the sheath62amay be advanced distally over the catheter61a. Alternatively, both the catheter61aand the sheath62amay be advanced simultaneously to enter into the patient.

Once the catheter61aand the sheath62aare inserted into the patient, they can be driven to advance through the vasculature of the patient. At sections of the vessel2000that are relatively straight, both the catheter61aand the sheath62amay be driven so that they move as one unit. Occasionally, the catheter61aand/or the sheath62amay reach a section of the vessel2000that has a bend (e.g., a sharp bend). In such cases, the catheter61aand the sheath62amay be driven in a telescopic manner to advance past the bend.

FIGS. 23A-23Billustrate such telescopic technique for advancing the sheath62aand the catheter61aover a bend2002along a length of the vessel2000. In this technique, the catheter61ais positioned with its distal articulation section traversing the bend2002and it is locked in this position (FIG. 23A). Next, the sheath62ais advanced over the catheter61a(FIG. 23B), and the catheter61aacts as a rail held in a fixed shape for the sheath62ato glide over. As the sheath62ais advanced further, sections with higher bending stiffness on the sheath62awill pass over the articulated section of the catheter61a, putting an increase load on the catheter61a. The increase in load on the catheter61amay tend to straighten the catheter61a. In some embodiments, the drive assembly of the robotic system10maintains the bent shape of the catheter61aby tightening the control wire(s), which has the effect of stiffening the catheter61a. In some embodiments, the robotic system10is configured to detect the increased load on the control wires (due to the placement of the sheath62aover the catheter61a) to be detected. The operator, or the robotic system10, can then apply an equal counteracting load on all the control wires of the catheter61ato ensure that its bent shape is maintained while the sheath62ais advanced over the bend. In other embodiments, the sheath62amay be extremely flexible so that it does not put any significant load on the catheter61aas the sheath62ais advanced over the catheter61a, and/or distort the anatomy.

Once the distal end of the catheter61areaches the target location (FIG. 23C), the distal end of the catheter61amay be steered to create a bend so that the distal opening at the catheter61afaces towards a tissue2010that is desired to be treated (FIG. 23D). The steering of the distal end of the catheter61amay be accomplished by receiving a user input at the workstation2, which generates a user signal in response to the user input. The user signal is transmitted to the controller, which then generates a control signal in response to the user signal. The control signal causes the drive assembly to apply tension to one or more wires inside the catheter61ato thereby bend the distal end of the catheter61aat the desired direction.

Next, the distal end2300of the elongate member26is deployed out of the lumen of the catheter61aby advancing the elongate member26distally (FIG. 23E). This may be accomplished robotically using the manipulator24, and/or manually. The sharp distal tip of the elongate member26allows the distal end2300to penetrate into the target tissue2010. Also, the flexible section320of the elongate member26allows the elongate member26to follow the curvature of the catheter61aas the elongate member26is advanced out of the lumen of the catheter61a. In some embodiments, the distal advancement of the elongate member26may be accomplished by receiving a user input at the workstation2, which generates a user signal in response to the user input. The user signal is transmitted to the controller, which then generates a control signal in response to the user signal. The control signal causes the elongate member manipulator24to turn its roller(s) to thereby advance the elongate member26distally.

After the distal end2300of the elongate member26is desirably positioned, the RF generator350is then activated to cause the distal end2300to deliver RF ablation energy to treat the target tissue2010. In some embodiments, if the system10includes the return electrode352that is placed on the patient's skin, the system10then delivers the energy in a monopolar configuration. In other embodiments, if the elongate member26includes the two electrodes370a,370b, the system10may then deliver the energy in a bipolar configuration. The energy is delivered to the target tissue2010for a certain duration until a lesion2020is created at the target site (FIG. 23E).

In some embodiments, while energy is being delivered by the elongate member26, cooling fluid may be delivered to the target site through the lumen in the elongate member26, and out of the distal port310and/or side port(s)312at the elongate member26. The cooling fluid allows energy to be delivered to the target tissue in a desired manner so that a lesion3020of certain desired size may be created. In other embodiments, the delivery of cooling fluid is optional, and the method does not include the act of delivering cooling fluid.

After the lesion3020has been created, the elongate member26may be removed from the catheter61a, and a substance2030may then be delivered to the target site through the lumen of the catheter61a(FIG. 23F). In some embodiments, the removal of the elongate member26from the catheter61amay be accomplished by receiving a user input at the workstation2, which generates a user signal in response to the user input. The user signal is transmitted to the controller, which then generates a control signal in response to the user signal. The control signal causes the elongate member manipulator24to turn its roller(s) to thereby retract the elongate member26proximally until the entire elongate member26is out of the lumen of the catheter61a.

In some embodiments, the substance2030may be an embolic material for blocking supply of blood to the target site. In other embodiments, the substance2030may be a drug, such as a chemotherapy drug, for further treating tissue at the target site. In further embodiments, the substance2030may be one or more radioactive seeds for further treating tissue at the target site through radiation emitted from the radioactive seed(s). In other embodiments, the delivery of the substance2030may be optional, and the method may not include the act of delivering the substance2030.

In some embodiments, if there is another target tissue (e.g., tumor) that needs to be treated, any or all of the above actions may be repeated. For example, in some embodiments, after the first tumor has been ablated, the distal end of the catheter61amay be steered to point to another direction, and the elongate member26may be deployed out of the catheter61aagain to ablate the second tumor. Also, in other embodiments, the catheter61amay be moved distally or retracted proximally along the length of the vessel2000to reach different target sites.

In other embodiments, instead of the telescopic configuration, the robotic system10may be configured to drive the catheter61aand the sheath62ain other configurations. For example, in some embodiments, the sheath62amay be bent and acts as guide for directing the catheter61ato move in a certain direction. In such cases, the robotic system10may be configured to relax the wires in the catheter61aso that the catheter61ais flexible as it is advanced distally inside the lumen of the sheath62a. Also, in other embodiments, the sheath62amay not be involved in the method. In such cases, the robotic system10may be configured to drive the catheter61awithout the sheath62ato advance the catheter61athrough the vasculature of the patient.

Also, in other embodiments, a guidewire may be used in combination with the catheter61aand/or the sheath62afor advancement of the catheter61aand/or the sheath62ainside the vessel of the patient. In such cases, the elongate member26is not inserted into the catheter61a. Instead, the guidewire is coupled to the elongate member manipulator24, and the guidewire is placed inside the lumen of the catheter61a. The manipulator24may then be used to drive the guidewire to advance and/or retract the guidewire. In some cases, the robotic system10may advance the guidewire, the catheter61a, and the sheath62ain a telescopic configuration, as similarly discussed.

If a guidewire is initially used to access the interior of the patient, the guidewire may be later exchanged for the elongate member26. For example, in some embodiments, the guidewire may be exchanged for the elongate member26after initial access of the main hepatic artery (or vein). After the distal end of the catheter61areaches the target site, the guidewire may then be removed from the lumen of the catheter61a, and decoupled from the elongate member manipulator24. The proximal end of the elongate member26is coupled to the elongate member manipulator24, and the elongate member26is then inserted into the lumen of the catheter61a. The elongate member manipulator24is then used to drive the elongate member26distally until the distal end2300of the elongate member26exits out of the distal end of the catheter61a, as similarly discussed.

In further embodiments, the elongate member26may not be needed to treat tissue. For example, in other embodiments, after the distal end of the catheter61ais desirably placed at a target site, the catheter61amay then be used to deliver a substance (e.g., an agent, a drug, radioactive seed(s), embolic material, etc.) to treat tissue at the target site without ablating the tissue. In some embodiments, the catheter61aitself may be directly used to deliver the substance. In other embodiments, another delivery device (e.g., a tube) may be placed inside the lumen of the catheter61a, and the delivery device is then used to deliver the substance. In such cases, the catheter61ais used indirectly for the delivery of the substance.

In some embodiments, during the treatment method, a localization technique may be employed to determine a location of the instrument inside the patient's body. The term “localization” is used in the art in reference to systems for determining and/or monitoring the position of objects, such as medical instruments, in a reference coordinate system. In one embodiment, the instrument localization software is a proprietary module packaged with an off-the-shelf or custom instrument position tracking system, which may be capable of providing not only real-time or near real-time positional information, such as X-Y-Z coordinates in a Cartesian coordinate system, but also orientation information relative to a given coordinate axis or system. For example, such systems can employ an electromagnetic based system (e.g., using electromagnetic coils inside a device or catheter body). Other systems utilize potential difference or voltage, as measured between a conductive sensor located on the pertinent instrument and conductive portions of sets of patches placed against the skin, to determine position and/or orientation. In another similar embodiment, one or more conductive rings may be electronically connected to a potential-difference-based localization/orientation system, along with multiple sets, preferably three sets, of conductive skin patches, to provide localization and/or orientation data. Additionally, “Fiberoptic Bragg grating” (“FBG”) sensors may be used to not only determine position and orientation data but also shape data along the entire length of a catheter or shapeable instrument. In other embodiments, imaging techniques may be employed to determine a location of the instrument inside the patient's body. For examples, x-ray, ultrasound, computed tomography, MRI, etc., may be used in some embodiments.

In other embodiments not comprising a localization system to determine the position of various components, kinematic and/or geometric relationships between various components of the system may be utilized to predict the position of one component relative to the position of another. Some embodiments may utilize both localization data and kinematic and/or geometric relationships to determine the positions of various components. The use of localization and shape technology is disclosed in detail in U.S. patent application Ser. Nos. 11/690,116, now abandoned, 11/176,598, now abandoned, 12/012,795, now abandoned, 12/106,254, issued as U.S. Pat. No. 8,050,523 on Nov. 1, 2011, 12/507,727, now abandoned, 12/822,876, issued as U.S. Pat. No. 8,460,236 on Jun. 11, 2013, 12/823,012, now abandoned, and 12/823,032, issued as U.S. Pat. No. 8,672,837 on Mar. 18, 2014, the entirety of all of which is incorporated by reference herein for all purposes.

Also, in one or more embodiments described herein, the system may further include a sterile barrier positioned between the drive assembly and the elongate member holder, wherein the drive assembly is configured to transfer rotational motion, rotational motion, or both, across the sterile barrier to the rotary members to generate the corresponding linear motion of the elongate member along the longitudinal axis of the elongate member, rotational motion of the elongate member about the longitudinal axis, or both linear motion and rotational motion.

As illustrated in the above embodiments, the robotic technique and system10for treating liver tissue is advantageous because it allows the ablation device to reach certain part(s) of the liver through the vessel that may otherwise not be possible to reach using conventional rigid ablation probe. For example, in some embodiments, using the robotic system10and the above technique may allow the distal end of the elongate member26to reach the lobus quatratus or the lobus spigelii of the liver, which may not be possible to reach by conventional ablation probe. Also, using the elongate member manipulator24to position the elongate member26is advantageous because it allows accurate positioning of the distal end2300of the elongate member26.

V. Other Clinical Applications

The different driving modes and/or different combinations of driving modes are advantageous because they allow an elongate instrument (catheter61a, sheath61b, elongate member26, or any combination thereof) to access any part of the vasculature. Thus, embodiments of the system described herein may have a wide variety of applications. In some embodiments, embodiments of the system described herein may be used to treat thoracic aneurysm, thoracoabdominal aortic aneurysm, abdominal aortic aneurysm, isolated common iliac aneurysm, visceral arteries aneurysm, or other types of aneurysms. In other embodiments, embodiments of the system described herein may be used to get across any occlusion inside a patient's body. In other embodiments, embodiments of the system described herein may be used to perform contralateral gait cannulation, fenestrated endograft cannulation (e.g., cannulation of an aortic branch), cannulation of internal iliac arteries, cannulation of superior mesenteric artery (SMA), cannulation of celiac, and cannulation of any vessel (artery or vein). In further embodiments, embodiments of the system described herein may be used to perform carotid artery stenting, wherein the tubular member may be controlled to navigate the aortic arch, which may involve complex arch anatomy. In still further embodiments, embodiments of the system described herein may be used to navigate complex iliac bifurcations.

In addition, in some embodiments, embodiments of the system described herein may be used to deliver a wide variety of devices within a patient's body, including but not limited to: stent (e.g., placing a stent in any part of a vasculature, such as the renal artery), balloon, vaso-occlusive coils, any device that may be delivered over a wire, an ultrasound device (e.g., for imaging and/or treatment), a laser, any energy delivery devices (e.g., RF electrode(s)), etc. In other embodiments, embodiments of the system described herein may be used to deliver any substance into a patient's body, including but not limited to contrast (e.g., for viewing under fluoroscope), drug, medication, blood, etc. In one implementation, after the catheter61a(leader) is placed at a desired position inside the patient, the catheter61aand the elongate member26may be removed, leaving the sheath61bto provide a conduit for delivery of any device or substance. In another implementation, the elongate member26may be removed, leaving the catheter61ato provide a conduit for delivery of any device or substance. In further embodiments, the elongate member26itself may be used to deliver any device or sub stance.

In further embodiments, embodiments of the system described herein may be used to access renal artery for treating hypertension, to treat uterine artery fibroids, atherosclerosis, and any peripheral artery disease. Also, in other embodiments, embodiments of the system described herein may be used to access the heart. In some embodiments, embodiments of the system may also be used to deliver drug or gene therapy.

In still further embodiments, embodiments of the system described herein may be used to access any internal region of a patient that is not considered a part of the vasculature. For example, in some cases, embodiments of the system described herein may be used to access any part of a digestive system, including but not limited to the esophagus, liver, stomach, colon, urinary tract, etc. In other embodiments, embodiments of the system described herein may be used to access any part of a respiratory system, including but not limited to the bronchus, the lung, etc.

In some embodiments, embodiments of the system described herein may be used to treat a leg that is not getting enough blood. In such cases, the tubular member may access the femoral artery percutaneously, and is steered to the aorta iliac bifurcation, and to the left iliac. Alternatively, the tubular member may be used to access the right iliac. In one implementation, to access the right iliac, the drive assembly may be mounted to the opposite side of the bed (i.e., opposite from the side where the drive assembly is mounted inFIG. 1). In other embodiments, instead of accessing the inside of the patient through the leg, the system may access the inside of the patient through the arm (e.g., for accessing the heart).

In any of the clinical applications mentioned herein, the telescopic configuration of the catheter61aand the sheath61b(and optionally the elongate member26) may be used to get past any curved passage way in the body. For example, in any of the clinical applications mentioned above, a guidewire placed inside the catheter61amay be advanced first, and then followed by the catheter61a, and then the sheath61b, in order to advance the catheter61aand the sheath61bdistally past a curved (e.g., a tight curved) passage way. Once a target location is reached, the guidewire may be removed from the catheter61a, and the elongate member26may optionally be inserted into the lumen of the catheter61a. The elongate member26is then advanced distally until its distal exits from the distal opening at the catheter61a. In other embodiments, the catheter61amay be advanced first, and then followed by the sheath61b, in order to advance the catheter61aand the sheath61bdistally past a curved (e.g., a tight curved) passage way. In still further embodiments, the guidewire may be advanced first, and then followed by the catheter61athe sheath61b(i.e., simultaneously), in order to advance the catheter61aand the sheath61bdistally past a curved (e.g., a tight curved) passage way.

Each of the individual variations described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other variations. Modifications may be made to adapt a particular situation, material, composition of matter, process, process act(s) or step(s) to the objective(s), spirit or scope of the present application. Also, any of the features described herein with reference to a robotic system is not limited to being implemented in a robotic system, and may be implemented in any non-robotic system, such as a device operated manually.

Methods recited herein may be carried out in any order of the recited events which is logically possible, as well as the recited order of events. Furthermore, where a range of values is provided, every intervening value between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed. Also, any optional feature described may be set forth and claimed independently, or in combination with any one or more of the features described herein.

All existing subject matter mentioned herein (e.g., publications, patents, patent applications and hardware) is incorporated by reference herein in its entirety except insofar as the subject matter may conflict with that described herein (in which case what is present herein shall prevail). The referenced items are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that any claimed invention is not entitled to antedate such material by virtue of prior invention.

Although particular embodiments have been shown and described, it will be understood that they are not intended to limit the claimed inventions, and it will be obvious to those skilled in the art having the benefit of this disclosure that various changes and modifications may be made. The specification and drawings are, accordingly, to be regarded in an illustrative rather than restrictive sense. The claimed inventions are intended to cover alternatives, modifications, and equivalents.