US20130317519A1

Movatterモバイル変換

Info

Publication number: US20130317519A1
Application number: US13/481,536
Authority: US
Inventors: Enrique Romo; J. Scot Hart, JR.; Travis Covington
Original assignee: Hansen Medical Inc
Current assignee: Hansen Medical Inc
Priority date: 2012-05-25
Filing date: 2012-05-25
Publication date: 2013-11-28
Also published as: US20160338783A1; US20220087755A1; US11147637B2

Abstract

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.

Description

INCORPORATION BY REFERENCE

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

U.S. patent application Ser. No. 13/173,994, filed on Jun. 30, 2011,
U.S. patent application Ser. No. 11/179,007, filed on Jul. 6, 2005,
U.S. patent application Ser. No. 12/079,500, filed on Mar. 26, 2008,
U.S. patent application Ser. No. 11/678,001, filed on Feb. 22, 2007,
U.S. Patent Application No. 60/801,355, filed on May 17, 2006,
U.S. patent application Ser. No. 11/804,585, filed on May 17, 2007,
U.S. patent application Ser. No. 11/640,099, filed on Dec. 14, 2006,
U.S. patent application Ser. No. 12/507,727, filed on Jul. 22, 2009,
U.S. patent application Ser. No. 12/106,254, filed on Apr. 18, 2008,
U.S. patent application Ser. No. 12/192,033, filed on Aug. 14, 2008,
U.S. patent application Ser. No. 12/236,478, filed on Sep. 23, 2008,
U.S. patent application Ser. No. 12/833,935, filed on Jul. 9, 2010,
U.S. patent application Ser. No. 12/822,876, filed on Jun. 24, 2010,
U.S. patent application Ser. No. 12/614,349, filed on Nov. 6, 2009,
U.S. patent application Ser. No. 11/690,116, filed Mar. 22, 2007,
U.S. patent application Ser. No. 11/176,598, filed Jul. 6, 2005,
U.S. patent application Ser. No. 12/012,795, filed Feb. 1, 2008,
U.S. patent application Ser. No. 12/837,440, Jul. 15, 2010,
U.S. Patent Application No. 61/513,488, filed Jul. 8, 2011, and
U.S. patent application Ser. No. 13/174,605, filed Jun. 30, 2011.

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.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate the design and utility of embodiments, in which similar elements are referred to by common reference numerals. These drawings are not necessarily drawn to scale. In order to better appreciate how the above-recited and other advantages and objects are obtained, a more particular description of the embodiments will be rendered, which are illustrated in the accompanying drawings. These drawings depict only typical embodiments and are not therefore to be considered limiting of its scope.

FIG. 1 illustrates a robotic surgical system in which apparatus, system and method embodiments may be implemented.

FIG. 2 illustrates how the adapter base plate assembly is utilized to attach a support assembly and instrument driver to an operating table or surgical bed.

FIG. 3 a sheath and guide catheter assembly, and an elongate member manipulator mounted on an instrument driver

FIG. 4 illustrates an example of an operator workstation of the robotic surgical system shown inFIG. 1 with which a catheter instrument can be manipulated using different user interfaces and controls.

FIG. 5A further illustrates the instrument driver shown inFIG. 3 without the elongate member manipulator mounted on an instrument driver.

FIG. 5B further illustrates the instrument driver shown inFIG. 5A without the sheath and guide catheter assembly.

FIG. 5C further illustrates the instrument driver shown inFIG. 5B with skins removed.

FIGS. 6A and 6B illustrate a sheath and guide catheter assembly positioned over respective sterile adaptors and mounting plates from top and bottom perspectives respectively

FIGS. 7A and 7B illustrate top and bottom perspectives respectively of a portion of an instrument driver with a sheath splayer positioned over a sterile adaptor.

FIG. 7C illustrates an exploded view of the sheath splayer shown inFIG. 7A without a purge tube.

FIG. 7D illustrates top and bottom views of a pulley assembly positioned over a floating shaft.

FIG. 7E illustrates the floating shaft ofFIG. 7D installed and un-installed onto a sleeve receptacle.

FIG. 8 illustrates a guide carriage of the instrument driver shown inFIG. 5C with pulleys and guide articulation motors.

FIG. 9 is a perspective view of a slidable carriage or funicular assembly of an instrument driver and sleeve receptacles configured to receive and engage with floating shafts.

FIG. 10 illustrates a sheath block, sheath insert motor, guide insert motor and leadscrews removed from the instrument driver shown inFIG. 5C.

FIGS. 10A and 10B illustrate different perspective views of the sheath block with sheath output plate positioned over receptacle sleeves.

FIG. 10C illustrates sheath articulation motors coupled to motor driven interfaces and receptacle sleeves.

FIGS. 11A-11H illustrate side and cross-sectional views of a catheter bent in various configurations with pull wire manipulation.

FIG. 12 illustrates an open loop control model.

FIG. 13 illustrates a control system in accordance with some embodiments.

FIG. 14 illustrates a user interface for a master input device.

FIG. 15 illustrates some components of a robotic system that includes tension sensing capability in accordance with some embodiments;

FIG. 16 illustrates some components of a robotic system that includes tension sensing capability in accordance with other embodiments;

FIG. 17 illustrates some components of a robotic system that includes tension sensing capability in accordance with other embodiments;

FIG. 18 illustrates a frictionless interface at a sterile adaptor in accordance with some embodiments;

FIG. 19 illustrates some components of a robotic system that includes tension sensing capability in accordance with other embodiments;

FIG. 20 illustrates some components of a robotic system that includes tension sensing capability in accordance with other embodiments;

FIG. 21 illustrates some components of a robotic system that includes tension sensing capability in accordance with other embodiments;

FIG. 22A illustrates driving mode(s) in accordance with some embodiments.

FIG. 22B illustrates driving mode(s) in accordance with other embodiments.

FIG. 22C illustrates driving mode(s) in accordance with other embodiments.

FIG. 22D illustrates driving mode(s) in accordance with other embodiments.

FIG. 23A-23F illustrates a method of using a robotic system to treat tissue in accordance with some embodiments.

DESCRIPTION OF THE EMBODIMENTS

Various embodiments are described hereinafter with reference to the figures. It should be noted that the figures are not drawn to scale and that elements of similar structures or functions are represented by like reference numerals throughout the figures. It should also be noted that the figures are only intended to facilitate the description of the embodiments. They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention. In addition, an illustrated embodiment needs not have all the aspects or advantages shown. An aspect or an advantage described in conjunction with a particular embodiment is not necessarily limited to that embodiment and can be practiced in any other embodiments even if not so illustrated.

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 controlledsurgical system10 in which embodiments of apparatus, system and method may be implemented includes anoperator workstation2, an electronics rack6 and associatedbedside 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 theoperator workstation2 and can monitor the surgical procedure, patient vitals, and control one or more robotic surgical devices.

Referring toFIG. 2, theinstrument driver16, setup joint mountingbrace20, and bedside electronics box are shown in greater detail. Referring toFIG. 3, theinstrument driver16 is illustrated including anelongate member manipulator24 and arobotic catheter assembly11 installed. Therobotic catheter assembly11 includes 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”). Thesheath instrument30 andcatheter instrument18 are controllable using theinstrument driver16. During use, a patient is positioned on an operating table or surgical bed22 (generally referred to as “operating table”) to which thesupport assembly20,instrument driver16, androbotic catheter assembly11 are coupled or mounted.

In the illustrated embodiments, the elongate member manipulator24 (generally referred to as “manipulator”) is configured for manipulating anelongate member26. In some embodiments, theelongate member26 may be a guidewire. In other embodiments, theelongate member26 may 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, theelongate member26 may be any of other instruments for medical use. During use, at least a part of theelongate member26 is disposed within a lumen of thecatheter instrument18, and the proximal end of theelongate member26 is removably coupled to themanipulator24. In some embodiments, themanipulator24 is configured to advance and retract theelongate member26 relative to thecatheter instrument18. In other embodiments, themanipulator24 may also be configured to roll theelongate member26 so 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 insystems10 in which components are separated from each other, e.g., located in separate rooms. For example, theinstrument driver16, operating table22, andbedside electronics box9 may be located in the surgical area with the patient, and theoperator workstation2 and the electronics rack6 may be located outside of the surgical area and behind a shielded partition.System10 components may also communicate withother system10 components 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 theoperator control station2 and theinstrument driver16.System10 components may also be coupled together via a plurality of cables or othersuitable connectors14 to provide for data communication, or one or more components may be equipped with wireless communication components to reduce or eliminatecables14. 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 anoperator workstation2 that may be used with thesystem10 shown inFIG. 1 includes threedisplay screens4, a touchscreen user interface5, a control button console orpendant8, and a master input device (MID)12. TheMID12 andpendant8 serve as user interfaces through which the surgeon can control operation of theinstrument driver16 and attached instruments. By manipulating thependant8 and theMID12, a surgeon or other operator can cause theinstrument driver16 to remotely control thecatheter instrument18 and/or thesheath instrument30 mounted thereon. Also, in some embodiments, by manipulating one or more controls at thestation2, the surgeon or operator may cause themanipulator24 to remotely move theelongate member26. Aswitch7 may be provided to disable activity of an instrument temporarily. Theconsole2 in the illustratedsystem10 may also be configurable to meet individual user preferences. For example, in the illustrated example, thependant8 and thetouch screen5 are shown on the left side of theconsole2, but they may also be relocated to the right side of theconsole2. Various numbers of display screens may be provided. Additionally or alternatively, abedside console3 may be provided for bedside control of the of theinstrument driver16 if desired. Further, optional keyboard may be connected to theconsole2 for inputting user data. Theworkstation2 may also be mounted on a set of casters or wheels to allow easy movement of theworkstation2 from one location to another, e.g., within the operating room or catheter laboratory. Further aspects of examples ofsuitable MID12, andworkstation2 arrangements are described in further detail in U.S. patent application Ser. No. 11/481,433 and U.S. Provisional Patent Application No. 60/840,331, the contents of which were previously incorporated herein by reference.

As shown inFIG. 1, thesupport assembly20 is configured for supporting or carrying theinstrument driver16 over the operating table22. Onesuitable support assembly20 has an arcuate shape and is configured to position theinstrument driver16 above a patient lying on the table22. Thesupport assembly20 may be configured to movably support theinstrument driver16 and to allow convenient access to a desired location relative to the patient. Thesupport assembly20 may also be configured to lock theinstrument driver16 into a certain position.

In the illustrated example, thesupport assembly20 is mounted to an edge of the operating table22 such that a catheter and

sheath instruments

18,30 mounted on theinstrument driver16 can be positioned for insertion into a patient. Theinstrument driver16 is controllable to maneuver the catheter and/or

sheath instruments

18,30 within the patient during a surgical procedure. The distal portion of the setup joint20 also includes a control lever33 for maneuvering the setup joint20. Although the figures illustrate asingle guide catheter18 andsheath assembly30 mounted on asingle instrument driver16, embodiments may be implemented insystems10 having other configurations. For example, embodiments may be implemented insystems10 that include a plurality ofinstrument drivers16 on which a plurality of catheter/

sheath instruments

18,30 can be controlled. Further aspects of asuitable support assembly20 are described in U.S. patent application Ser. No. 11/481,433 and U.S. Provisional Patent Application No. 60/879,911, the contents of which are expressly incorporated herein by reference. Referring toFIG. 2, thesupport assembly20 may be mounted to an operating table22 using a universal adapterbase 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. Theadapter plate assembly39 mounts directly to the operating table22 using clamp assemblies, and thesupport assembly20 may be mounted to theadapter plate assembly39. One suitableadapter plate assembly39 includes two large, flat main plates which are positioned on top of the operating table22. Theassembly39 provides for various adjustments to allow it to be mounted to different types of operating tables22. An edge of theadapter plate assembly39 may 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 thesupport assembly20. Furthermore, the large, flat surface of the main plate provides stability by distributing the weight of thesupport assembly20 andinstrument driver16 over an area of the table22, whereas asupport assembly20 mounted directly to the operating table22 rail may cause its entire load to be placed on a limited and less supportive section of the table22. Additionally or alternatively, abedside rail13 may be provided which may couple thesupport assembly20 to 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 theinstrument driver16 and ultimately a translation in the insert direction of the catheter andsheath instruments18/30.

FIGS. 5A-C illustrate theinstrument drive16 with various components installed.FIG. 5A illustrates theinstrument driver16 with theinstrument assembly11 installed including thesheath instrument30 and the associated guide orcatheter instrument18 whileFIG. 5B illustrates theinstrument driver16 without an attachedinstrument assembly11. Thesheath instrument30 and the associatedguide instrument18 are mounted to associated mounting

plates

37,38 on a top portion of theinstrument driver16.FIG. 5C illustrates theinstrument driver16 with 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, 11/678,016, and 11/804,585, each incorporated by reference herein in its entirety.

Referring toFIGS. 6A-B, theassembly11 that includes thesheath instrument30 and the guide orcatheter instrument18 positioned over their

respective mounting plates

38,37 is illustrated removed from theinstrument driver16. Additionally asterile adaptor41 can be used to couple each of the sheath and guide instruments to their respective mounting plates. Thecatheter instrument18 includes a guidecatheter instrument member61a, and thesheath instrument30 includes asheath instrument member62a.The guidecatheter instrument member61ais coaxially interfaced with thesheath instrument member62aby inserting the guidecatheter instrument member61ainto a working lumen of thesheath catheter member62a.As shown inFIG. 6A, thesheath instrument30 and the guide orcatheter instrument18 are coaxially disposed for mounting onto theinstrument driver16. However, it should be understood that thesheath instrument16 may be used without a guide orcatheter instrument18, or the guide orcatheter instrument18 may be used without asheath instrument30. In such cases, thesheath instrument16 or thecatheter instrument18 may be mounted onto theinstrument driver16 individually. With the coaxial arrangement as shown inFIG. 6A, aguide catheter splayer61 is located proximally relative to, or behind, asheath splayer62 such that theguide catheter member61acan be inserted into and removed from the sheath catheter member61b.

The

splayers

61,62 are configured to steer themembers61a,61b, respectively. In the illustrated embodiments, each of the

splayers

61,62 includes drivable elements therein configured to apply tension to different respective wires inside themember61a/61bto thereby steer the distal end of themember61a/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 thework station2, and generates the control signal in response to the input signal. Also, in the illustrated embodiments, the

splayers

61,62 may be translated relative to theinstrument driver16. In some embodiments, theinstrument driver16 may be configured to advance and retract each of the

splayers

61,62, so that thecatheter instrument18 and thesheath instrument30 may be advanced distally and retracted proximally.

FIGS. 7A and 7B illustrate thesheath splayer62 of one embodiment illustrated with thesterile adaptor41 and mountingplate38 coupled 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

splayers

62,61, appear similar physically in construction with the exception of differences in avalve purge tube32. It should be noted that thepurge tube32 may or may not be included for either the guide or sheath splayer. The sheath splayer62 will be described herein. However it should be understood that theguide splayer61 is of similar construction, and components of thesheath splayer62 can be repeated for theguide splayer61.

As illustrated inFIG. 7C, thesplayer62 includes asplayer cover72 fixably coupled to asplayer base assembly78 using fourscrews79. Thesplayer base78 having four cavities to receive and housepulley assemblies80 is used for both theguide splayer61 andsheath splayer62. For this embodiment of asheath splayer62, four cavities of thesplayer base78 are populated withpulley assemblies80 but it should be understood that varying numbers of cavities may be populated leaving remaining cavities open. Theguide splayer61 may have all its cavities populated with fourpulley assemblies80 for pulling four respective wires, as can be seen inFIG. 6B. Thesplayer base78 of this implementation can be constructed from injection molded polycarbonate.

Duringsplayer62 assembly, thepulley assembly80 is 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, thesheath splayer62 is placed onto thesheath mounting plate38 and theguide splayer61 is place onto theguide mounting plate37 viasterile adaptors41. Referring toFIG. 7A-B, thepulley assemblies80 are configured to couple to floatingshafts82 on thesplayer adaptor41 which in turn are configured to couple tosleeve receptacles90. In the illustrated example, each mounting

plates

37,38 has four

openings

37a,38athat are designed to receive the corresponding floatingshafts84 attached to and extending from thesterile adaptors41 coupled to the

splayers

61,62. In the example illustrated inFIG. 6B, four floatingshafts82 of thesterile adaptor41 are insertable within theopenings38aof thesheath mounting plate38 as thesplayer62 is mounted onto the RCM. Similarly, four floatingshafts82 of thesterile adaptor41 are insertable within the four apertures oropenings37aof theguide interface plate37. Referring toFIGS. 7D-E, the coupling of thepulley assemblies80 to floatingshafts82 and floatingshafts82 tosleeve receptacles90 is illustrated.FIG. 7D illustrates top and bottom perspective views of thepulley assembly80 positioned above the floatingshaft82 where the bottom of thepulley assembly80 is configured to mate with splines on the top of the floatingshaft82.FIG. 7E illustrates the floatingshaft82 installed and un-installed onto thesleeve receptacle90. The sleeve receptacles can include anotch90ashaped to accept apin84 on the floatingshaft82.

Referring back toFIGS. 7A-B, thesheath splayer62 is shown havinglatches73 which may couple to hooks86. By depressing thelatches73, thesplayer62 may be locked and unlocked to thesterile adaptor41. The sterile adaptor in turn is configured having mounting hooks88 which couple to slidinglatches77 on the mounting plate83. The sliding latches77 can be spring loaded to allow theadaptor plate41 to be locked to the mountingplate38 by applying downward force on theadaptor plate41. The sliding latches can be depressed to release theadaptor plate41 when desired.

The sheathinterface mounting plate38 as illustrated inFIGS. 6A and 6B is similar to the guideinterface mounting plate37, and thus, similar details are not repeated. One difference between the

plates

37,38 may be the shape of the plates. For example, theguide interface plate37 includes a narrow, elongated segment, which may be used with, for example, a dither mechanism or theelongate member manipulator24. Both

plates

37,38 include a plurality of

openings

37a,38ato receive floatingshafts82 and latches73 fromsterile adaptors41. Thesplayers61/62,sterile adaptors41, and mountingplates37/38 are all described in greater detail in U.S. patent application Ser. No. 13/173,994, filed on Jun. 30, 2011, the entire disclosure of which is expressly incorporated by reference herein.

Referring back toFIG. 5C theinstrument driver16 is illustrated with mounting

plates

37,38 fixably coupled to aguide carriage50, and asheath drive block40, respectively.FIG. 8 illustrates theguide carriage50 removed from theinstrument driver16 coupled to cabling (not shown) and associatedguide motors53. Theguide carriage50 includes afunicular assembly56 which is illustrated inFIG. 9. Thefunicular assembly56 includes the foursleeve receptacles90. As previously described, the floatingshafts82 of thesterile adaptor41 first insert through theopenings37ain the mountingplate37. They then engage with thesleeve receptacles90

Referring back toFIG. 8, a set of cables (not shown) wound around a set ofpulleys52, are coupled on one end to a set ofguide motors53 and the other end to thesleeve receptacles90. Note that only two of four motors can be seen inFIG. 8. Thedrive motors53 are actuated to rotationally drive thesleeves90. Thecatheter assembly18 with itssplayer61 mounted onto theinstrument drive16 would have itspulley assemblies80 coupled to correspondingsleeves90 via floatingshafts82. As thesleeves90 are rotated, thepins84 of the floatingshafts82 are seated in the V-shaped notches and are engaged by the rotatingsleeves90, thus causing the floatingshafts82 and associatedpulley assemblies80 to also rotate. Thepulley assemblies80 in turn cause the control elements (e.g., wires) coupled thereto to manipulate the distal tip of thecatheter instrument30 member in response thereto.FIGS. 10A and 10B illustrate top and bottom perspective views of thesheath output plate38 exploded from thesheath block40 and motor driveninterfaces42 which are coupled tosheath articulation motors43.FIG. 10C illustratessheath articulation motors43 coupled to the motor driveninterfaces42 which 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 sheathsplayer pulley assemblies80 and sterileadaptor floating shafts82 are coupled to thereceptacle sleeves90, thesheath articulation motors43 drive thereceptacle sleeves90 causing thesheath instrument30 to bend in the same manner described for the guide instrument.

During use, thecatheter instrument18 is inserted within a central lumen of thesheath instrument30 such that the

instruments

18,30 are arranged in a coaxial manner as previously described. Although the

instruments

18,30 are arranged coaxially, movement of each

instrument

18,30 can be controlled and manipulated independently. For this purpose, motors within theinstrument driver16 are controlled such that the drive and sheath carriages coupled to the mounting

plates

37,38 are driven forwards and backwards independently on linear bearings each with leadscrew actuation.FIG. 10 illustrates thesheath drive block40 removed from the instrument driver coupled to two independently-actuated

lead screw

45,46 mechanisms driven by guide and

sheath insert motors

47a,47b.Note the guide carriage is not shown. In the illustrated embodiment, thesheath insertion motor47bis coupled to asheath insert leadscrew46 that 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 aguide insert motor47ais coupled to theguide insert leadscrew45 via a belt.

Referring back toFIGS. 1,4 and6A, in order to accurately steer therobotic sheath62aorguide catheter61afrom anoperator work station2, a control structure may be implemented which allows a user to send commands through input devices such as thependant8 orMID12 that will result in desired motion of thesheath62aand guide61a. In some embodiments, thesheath62aand/or theguide61amay each have four control wires for bending the instrument in different directions. Referring toFIGS. 11A-H, the basic kinematics of acatheter120 with four

control elements

122a,122b,122c,122dis shown. Thecatheter120 may becomponent61aorcomponent62ain some embodiments. Referring toFIGS. 11A-B, as tension is placed only upon thebottom control element122c,the catheter bends downward, as shown inFIG. 11A. Similarly, pulling theleft control element122dinFIGS. 11C-D bends the catheter left, pulling theright control element122binFIGS. 11E-F bends the catheter right, and pulling thetop control element122ainFIGS. 11G-H bends 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 thecatheter 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. 12-13 illustrate examples of a control structure for moving thecatheter61aand/or thesheath62ain 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 computer400 running 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 themaster input device12 depicted inFIG. 2 are available from suppliers such as Force Dimension of Lausanne, Switzerland. Themaster input device12 may also have haptics capability to facilitate feedback to the operator, and the software modules pertinent to such functionality may also be operated on themaster computer126.

Referring toFIG. 13, in one embodiment, visualization software runs on themaster computer126 to 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 amaster input device12. In the depicted embodiment, two

display views

142,144 are shown. One preferably represents a primary142 navigation view, and one may represent a secondary144 navigation 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 usefulprimary navigation view142 may comprise a three dimensional digital model of thepertinent tissue structures146 through which the operator is navigating the catheter with themaster input device12, along with a representation of the catheterdistal tip location148 as viewed along the longitudinal axis of the catheter near the distal tip. This embodiment illustrates a representation of a targetedtissue structure location150, which may be desired in addition to the tissuedigital model146 information. A usefulsecondary 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 thecatheter tip representation148, and also perhaps acatheter body representation152, to facilitate the operator's driving of the catheter tip toward the desired targetedtissue 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 amaster input device12 coordinate system to synchronize with the selected primary view. In an embodiment with the leftmost depictedview142 selected as the primary view, to navigate toward the targetedtissue site150, the operator should manipulate themaster input device12 forward, 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 targetedtissue site150 watching only therightmost view144 without themaster input device12 coordinate system synchronized with such view, the operator would have to remember that pushing straight ahead on the master input device will make thedistal tip representation148 move to the right on therightmost display144. Should the operator decide to toggle the system to use therightmost view144 as the primary navigation view, the coordinate system of themaster input device12 is then synchronized with that of therightmost view144, enabling the operator to move thecatheter tip148 closer to the desired targetedtissue location150 by manipulating themaster input device12 down 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, themaster computer126 also 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 themaster input device12. Themaster computer126 has two separate functional connections with the control and instrument driver computer128: oneconnection132 for passing controls and visualization related commands, such as desired XYZ (in the catheter coordinate system) commands, and oneconnection134 for passing safety signal commands. Similarly, the control andinstrument driver computer128 has two separate functional connections with the instrument and instrument driver hardware130: oneconnection136 for passing control and visualization related commands such as required-torque-related voltages to the amplifiers to drive the motors and encoders, and oneconnection138 for passing safety signal commands. Also shown in the signal flow overview ofFIG. 13 is apathway140 between the physical instrument andinstrument driver hardware130 back to themaster computer126 to 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.

II. Tension Sensing.

As discussed with reference toFIGS. 6-7, therobotic system10 includes an instrument driver (or drive assembly)16 withsleeve receptacles90 for turning therespective shafts82 at thesterile adaptor41, which in turn, rotates therespective pulley assemblies80 at thesplayer61/62. In some embodiments, therobotic system10 may further include a sensor for sensing a characteristic that corresponds with an amount of force or torque being applied to turn thesleeve receptacles90.FIG. 15 illustrates some components of therobotic system10 that includes tension sensing capability in accordance with some embodiments. As shown in the figure, theinstrument driver16 includes thesleeve receptacles90, which are actuatable elements that are actuated byrespective motors200. Theinstrument driver16 also includessensors202 coupled to therespective motors200. Eachsensor202 is configured to sense a characteristic that corresponds with an amount of force or torque being applied to theactuatable element90. Thesensor202 is illustrated schematically as being coupled to themotor200. In some embodiments, thesensor202 may be located internally inside a motor. In other embodiments, thesensor202 may be secured to an exterior of a motor. In other embodiments, thesensor202 may be attached to a component that is coupled to the motor. For example, in some embodiments, themotor200 may be mounted to a ring structure (like thering structure300 shown inFIG. 19) that is attached to theinstrument driver16. In such cases, thesensor202 may be attached to the ring structure, and thesensor202 may be considered as being coupled to the motor200 (indirectly, in this example).

Therobotic system10 also includes thesterile adaptor41, which has a base220 with a plurality ofopenings224 for housingrespective rotary members82. In the illustrated embodiments, therotary members82 are shafts configured for detachably coupling torespective sleeve receptacles90. In particular, eachrotary member82 has afirst end210 for insertion into thesleeve receptacle90, asecond end212, and abody214 extending between the first and second ends210,212. Thesterile adaptor41 also includes acover222 that is coupled to thebase220, and a flexible sheet (membrane)226 for providing a sterile barrier so that after thesplayer assembly61/62 is used, thesterile adaptor41 and thesplayer assembly61/62 may be discarded, while leaving theinstrument driver16 sterile.

Therobotic system10 also includes thesplayer61/62, which includes a base78 with a plurality ofopenings230 for housingrespective pulley assemblies80, and acover72 for coupling to thebase78. When thecover72 is coupled to thebase78, it covers thepulley assemblies80. Thesplayer61/62 also includes anelongate member61a/62acoupled to the base78 (e.g., either directly to thebase78, or indirectly to the base78 through the cover72). Theelongate member61a/62amay be a catheter, a sheath, or any elongate instrument having a lumen extending therethrough. Therobotic system10 also includes a plurality ofsteering wires204 disposed in theelongate member61a/62a. Eachsteering wire204 has a distal end coupled to a distal end of the elongate member, and a proximal end coupled to one of thepulley assemblies80. During use, the pulley assembly may be rotated to apply tension to thesteering wire204 to thereby apply tension to thesteering wire204, which in turn, causes the distal end of theelongate member61a/62ato bend. Although twopulley assemblies80 are shown, it should be understood that in other embodiments, thesplayer61/62 may have more than two pulley assemblies80 (e.g., four pulley assemblies80), withrespective steering wires204 connected thereto. Also, in other embodiments, thesplayer61/62 may have only onepulley assembly80, and theelongate member61a/62amay have only onesteering wire204 connected to thepulley assembly80.

As shown in the figure, theactuatable element90 is configured to turn thepulley assembly80 indirectly through therotary member82 at thesterile adaptor41 to thereby apply tension to thesteering wire204 at thecatheter61a/sheath62a.Thesensor202 is configured to sense a characteristic that corresponds with an amount of force being applied to theactuatable 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 thesteering wire204. In some embodiments, the sensed characteristic may be transmitted from thesensor202 to theuser 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 thesensor202 in a form of a signal to a processor, which processes the signal, and controls an amount of torque/force being applied to themotor200 in response to the processed signal.

In some embodiments, in order to accurately correlate the sensed characteristic by thesensor202 with an amount of tension being applied at thesteering wire204, it may be desirable to minimize, or at least reduce an amount of friction between theshaft82 and the base220 at thesterile adaptor41. In the illustrated embodiments, thesterile adaptor41 includes an interface between eachrotary member82 and thebase220 for reducing an amount of friction therebetween (i.e., between theshaft body214 of therotary member82 and the wall in theopening224 defined by the base220). As shown in the figure, eachrotary member82 includes aflange240 disposed circumferentially around theshaft body214, and a plurality ofslots242 at theflange240. Twoslots242 are shown, which are defined by apartition244 extending round theshaft body214 of therotary member82. Thepartition244 may have a ring configuration. For example, thepartition244 may have a continuous ring structure, or alternatively, a plurality of structures that form a ring configuration. Eachslot242 has a ring configuration that extends around theshaft body214 of therotary member82. Also, as shown in the figure, thebase220 includes aprotrusion246 next to (e.g., within 5 cm or less from) theopening224. Theprotrusion246 has a ring configuration around theopening224, and extends into aslot242. For example, theprotrusion246 may have a continuous ring structure, or alternatively, may have a plurality of structures that form into a ring configuration. Although oneprotrusion246 is shown in the example, in other embodiments, thesterile adaptor41 may include a plurality ofprotrusions246 that extend into respective ones of theslots242 at theflange240. Also, in other embodiments, theflange240 of therotary member82 may include more than twoslots242, or less than two slots242 (e.g., only one slot242).

In the illustrated embodiments, the cross sectional dimension of theshaft body214 is 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)244 at theflange240 and the protrusion(s)246 at the base220 cooperate with each other (e.g., engage with each other) to prevent theshaft214 from touching the surrounding wall at theopening224. Accordingly, theshaft body214 essentially “floats” within the space defined by theopening224. In the illustrated embodiments, thepartition244 abuts against theprotrusion246 while theshaft body214 is maintained within theopening224 so that it is spaced away from the wall of theopening224. In other embodiments, thepartition244 may not abut against theprotrusion246. Instead, there may be a small gap between thepartition244 and theprotrusion246 to reduce friction between thepartition244 and theprotrusion246. The gap may be large enough to allow some movement of theshaft body214 relative to thebase220, while small enough to prevent theshaft body214 from touching the wall at theopening224.

In some embodiments, to further provide a frictionless interface, the partition(s)244 and/or the protrusion(s)246 may 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)244 and/or the protrusion(s)246.

During use, thesterile adaptor41 is detachably coupled to theinstrument driver16. Such may be accomplished by inserting the first ends210 of the respectiverotary members82 into respective openings at the acutatable elements90 (like that shown inFIG. 7E). Themembrane226 provides a barrier to prevent theinstrument driver16 from being contaminated during a medical procedure. Also, during use, thesplayer61 is detachably coupled to thesterile adaptor41. Such may be accomplished by inserting the second ends212 of the respsectiverotary members82 into respective openings at the end of the rotary members80 (like that shown inFIG. 7D).

The same setup may be performed for thesplayer62. In particular, during use, anothersterile adaptor41 is detachably coupled to theinstrument driver16. Such may be accomplished by inserting the first ends210 of the respectiverotary members82 into respective openings at the acutatable elements90 (like that shown inFIG. 7E). Also, thesplayer62 is detachably coupled to thesterile adaptor41. Such may be accomplished by inserting the second ends212 of the respectiverotary members82 into respective openings at the end of the rotary members80 (like that shown inFIG. 7D).

After the

splayers

61,62 are mounted to respectivesterile adaptors41, and after thesterile adaptors41 are mounted to theinstrument driver16, therobotic system10 may then be used to perform a medical procedure. For example, in some embodiments, thesplayer61 and/orsplayer62 may be controlled to position thecatheter61aand/or thesheath62aat desired position(s) within the patient. Once thecatheter61aand/or thesheath62ahave been desirably positioned, thecatheter61aand/or thesheath62amay 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 thecatheter61aand/or thesheath62ato thereby place these instruments at desired positions(s) in the patient. In some embodiments, theinstrument driver16 may be configured to translate thesplayer61 to thereby translate thecatheter61ain an axial direction. Also, theinstrument driver16 may be configured to translate thesplayer62 to thereby translate thesheath62ain an axial direction. Thus, by moving thesplayer61 and/orsplayer62, theinstrument driver16 may advance or retract thecatheter61arelative to thesheath62a,and vice versa. Also, if the movements of the

splayers

61,62 are synchronized, both thecatheter61aand thesheath62amay be moved by the same amount in some embodiments. In some embodiments, the translation of thesplayer61 and/or thesplayer62 may be performed by theinstrument driver16 in response to a command signal received from the user interface. For example, in some embodiments, theinstrument driver16 may 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

splayers

61,62.

Also, in some embodiments, theinstrument driver16 may be configured to bend a distal end of thecatheter61a,a distal end of thesheath62a,or both. For example, in some embodiments, theinstrument driver16 may actuate one or more motors at theinstrument driver16 to turn one or more respectiveactuatable elements90, thereby turning one or more respectiverotary members80 at thesplayer61 indirectly through the one or more respectiverotary members82 at thesterile adaptor41. The turning of the one or morerotary members80 at thesplayer61 applies tension to one or more respective steering wires to thereby bend thecatheter61atowards a certain direction.

In some embodiments, as therotary member80 is being turned to apply tension to thesteering wire204, thesensor202 senses a characteristic that correlates with an amount of force or torque being applied by theactuatable element90. For example, in some embodiments, thesensor202 may be a torque sensor configured to measure an amount of torque being applied to theactuatable 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 thesteering wire204. For example, in some cases, the force value may be considered to be the amount of tension being applied to thesteering wire204. In other embodiments, thesensor202 may be a force sensor configured to measure a force vector that is in opposite direction as the tension force at thesteering wire204. Because of the frictionless interface at thesterile adaptor41, the force sensed by thesensor202 may 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 thesteering wire204.

Also as illustrated in the above embodiments, the frictionless interface at thesterile adaptor41 is advantageous because it significantly remove all or most of the friction between therotary member82 and its surrounding wall in theopening224. Thus, the frictionless interface at thesterile adaptor41 is preferred over rubber seal, and therobotic system10 does not include any rubber seal between therotary member82 and thebase220 of thesterile adaptor41.

In the above embodiments, therotary member80 at thesplayer61/62 has been described as having an opening at one end of therotary member80 for receiving thesecond end212 of therotary member82 at thesterile adaptor41. In other embodiments, the configuration of the coupling may be reversed. For example, in other embodiments, therotary member80 at thesplayer61/62 may have an end for insertion into an opening at thesecond end212 of therotary member82 at the sterile adaptor41 (FIG. 16).

Also, in the above embodiments, thefirst end210 of therotary member82 at thesterile adaptor41 has been described as being inserted into an opening at theactuatable element90 at theinstrument driver16. In other embodiments, the configuration of the coupling may be reversed. For example, in other embodiments, thefirst end210 of therotary member82 at thesterile adaptor41 may have an opening for receiving an end of theactuatable element90 at the instrument driver16 (FIG. 17). Furthermore, in other embodiments, thesecond end212 of therotary member82 in the embodiments ofFIG. 17 may 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 thesterile adaptor41 includes twoslots242 and aprotrusion246 inserted into one of theslots242. In other embodiments, the frictionless interface may include anadditional protrusion246 extending into thesecond slot242. Also, in further embodiments, the frictionless interface may include only one slot242 (FIG. 18).

As discussed, thesensor202 is coupled to themotor200, either directly or indirectly. Various techniques may be employed for coupling thesensor202 to themotor200. In some embodiments, thesensor202 may be a strain gauge mounted to an output shaft. In other embodiments, thesensor202 may 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, thesensor202 may be attached to the mountingstructure300. 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 mountingstructure300 has a ring configuration in some embodiments. In other embodiments, the mountingstructure300 may have other configurations. Also, in some embodiments, the mountingstructure300 may be considered to be a part of thesensor202. 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, thesensor202 may pick up inertial forces from the acceleration and deceleration of themotor200. Options for minimizing this contamination include (1) low-pass filtering the measured signal, (2) using only data collected when themotor200 is stationary or moving at an approximately constant velocity, and/or (3) modeling the inertial effects of themotor200, and compensating the measured signal based upon a measured acceleration by an encoder at themotor200 and/or motor back-EMF.

In other embodiments, by mounting the axis of themotor200 at 90° relative to the axis of the output shaft, the inertia forces due to acceleration and deceleration of themotor200 will be decoupled from the measured reaction torque (FIG. 20). As shown in the figure therobotic system10 may optionally further include agear box310 for transmitting torque from themotor200 to the output shaft that is axially aligned with theactuatable 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, theinstrument driver16 may include adifferential gearbox320 mechanically coupled to the motor200 (FIG. 21). Thegearbox320 is configured to turn afirst output shaft322 that is coupled to theactuatable element90, while asecond output shaft324 extending from thegearbox320 is fixed to the instrument driver16 (e.g., to a chassis of the instrument driver16). In some embodiments, thesecond output shaft324 may be fixed to theinstrument driver16 through the sensor202 (see option A in figure), which may be a torque sensing element in some embodiments. Alternatively, thesecond output shaft324 may be fixed to theinstrument driver16 without using thesensor202, 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). Thegearbox320 is advantageous because it allows thesensor202 to be coupled to a component that experiences torque from thegearbox320, 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 thesensor202 is coupled to a spinning shaft). In some embodiments, thegearbox320 may 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 shafts

322,324 may be due to inefficiencies of thedifferential gearbox320. In such cases, by maximizing the efficiency of thedifferential gearbox320, thesensor202 may 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. 21 may be simplified by incorporating the secondary (fixed)output shaft324 and thesensor202 entirely within a housing of thedifferential 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, thesystem10 may be configured to move thesheath62adistally or proximally, move thecatheter61adistally or proximally, and to move theelongate member26 distally or proximally. In some cases, the movement of thesheath62amay be relative to thecatheter61a, while thecatheter61aremains stationary. In other cases, the movement of thecatheter61amay be relative to thesheath62awhile thesheath62aremains stationary. Also, in other cases, thesheath62aand thecatheter61amay be moved together as a unit. Theelongate member26 may be moved relative to thesheath62aand/or thecatheter61a. Alternatively, theelongate member26 may be moved together with thesheath62aand/or thecatheter61a.

In some embodiments, theworkstation2 is 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 theworkstation2 and/or the bedside control402.

Elongate member Insert—When this button/command is selected, themanipulator24 inserts theelongate member26 at a constant velocity.

Elongate member Roll—When this button/command is selected, themanipulator24 rolls theelongate member26 at a constant angular velocity

Elongate member Size—When the size or gauge of theelongate member26 is inputted into through the user interface, the system will automatically alter roll and insert actuation at the proximal end of theelongate member26 accordingly 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 thatelongate member26. So if the user commands theelongate member26 to 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 members26 with 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 sizedelongate members26 behave differently.

Leader/Sheath Select—When this button/command is selected, it allows the user to select which device (e.g.,catheter61a,

sheath

62a,

elongate member

26, 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 thecatheter61a/sheath62awhile holding theelongate member26 and any non-active device fixed relative to the patient. When this motion causes the protruding section of thecatheter61ato approach zero (due to insertion of thesheath62aor retraction of thecatheter61a), the system automatically relaxes thecatheter61aas part of the motion.

Leader/Sheath Bend—When this button/command is selected, the instrument driver assembly bends the articulating portion of thecatheter61a/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/orsheath62a) 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 thecatheter61a/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, theelongate member26 position is locked to thecatheter61aposition. As the leader is articulated or inserted, theelongate member26 moves with thecatheter61aas one unit.

System Advance/Retract—When this button/command is selected, the instrument driver assembly advances/retracts thecatheter61aandsheath62atogether as one unit. Theelongate member26 is controlled to remain fixed relative to the patient.

Autoretract—When this button/command is selected, the instrument driver assembly starts by relaxing and retracting thecatheter61ainto thesheath62a,and then continues by relaxing and retracting thesheath62awith thecatheter61ainside it. Theelongate member26 is controlled to remain fixed relative to the patient.

Initialize Catheter—When this button/command is selected, the system confirms that thecatheter61aand/or thesheath62ahas 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 thecatheter61aand/or thesheath62a.

Leader/Sheath Re-calibration—When this button/command is selected, the instrument driver assembly re-pretensions thecatheter61aand/or thesheath62ain 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 thecatheter61ahas 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 thecatheter61ais fully retracted into thesheath62a,all tension is released from the pullwires, and the splayer shafts (at thedrivable assembly61 and/or drivable assembly62) are driven back to their original install positions so that thecatheter61acan 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 thecatheter61ais removed manually.

Emergency Stop—When this button/command is selected, the instrument driver assembly initiates a gradual (e.g., 3 second) relaxation of both thecatheter61aand thesheath62a.The components (e.g., amplifier) for operating thecatheter61a,

elongate member

26, 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 thecatheter61ais still in its allowable workspace and then returns to a normal driving state.

Segment control: In some embodiments, theworkstation2 allows a user to select individual segment(s) of a multi-segment catheters (such as the combination of thecatheter61aand thesheath62a), 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 theworkstation2 to 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, theworkstation2 allows 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.,catheter61aandsheath62a) to control. This section is then controlled using theworkstation2 to 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 theworkstation2 is 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. 22D where the distal segment (which may be a guidewire or a steerable instrument in some embodiments) has been driven out as shown inframe1. The “follow” command could be executed by articulating and/or inserting only the middle segment (which may be thecatheter61ain some embodiments) of the elongate instrument as shown inframe2. The “follow” command could be executed by articulating and/or inserting only the most proximal segment (which may be thesheath62ain some embodiments) of the elongate instrument as shown inframe3. The “follow” command could also be executed by coordinating the articulation and/or insertion of multiple proximal segments of the elongate instrument as shown inframe4. 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, theworkstation2 allows 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 inFrame1, there are several options available for how to achieve this command: (1) Articulate and extend the “active” segment, which is illustrated inframe3 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 and4; (3) Articulate the active distal most segment and combine inserting motion of some or all of the segments, as illustrated inframe5.

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., thecatheter61a) disposed around the flexible elongated member, and a second member (e.g., thesheath62a) disposed around the first member. The flexible elongated member may have a pre-formed (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 themember26. 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 thecatheter61a,thesheath62a,or both. In particular, one or both of thecatheter61aand thesheath62amay be stiffened (e.g., by applying tension to one or more wires inside thecatheter61aand/or thesheath62a). The stiffenedcatheter61aand/or thesheath62amay then be used to provide support for the guidewire.

Also, in some of the embodiments described herein, any movement of theelongate member26, thecatheter61a, and/or thesheath62amay 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 theelongate member26, thecatheter61a,and/or thesheath62a.

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-23F illustrate a method of treating tissue using therobotic system10 in accordance with some embodiments. As an example, the method will be described with reference to treating liver tissue. However, it should be understood that thesystem10 may be used to treat other types of tissue.

First, therobotic system10 is setup by placing thecatheter61 into the lumen of thesheath62, and by placing theelongate member26 into the lumen of thecatheter61. Next, an incision is then made at a patient's skin, and the distal end of thecatheter61 is then inserted into the patient through the incision. In particular, the distal end of thecatheter61 is 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 thecatheter61 into the patient may be performed manually. In other embodiments, the initial insertion of thecatheter61 may be performed robotically using thesystem10. In such cases, the user may enter a command at theworkstation2, 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 thecatheter61 so that it advances distally into the patient. In some embodiments, while thecatheter61 is being inserted into the patient, thedistal end2300 of theelongate member26 may be housed within the lumen of thecatheter61. In other embodiments, thedistal end2300 of theelongate member26 may extend out of the lumen of the catheter61 (which theflexible section320 of theelongate member26 is housed within the lumen of the catheter61) as thecatheter61 is being inserted. In such cases, the sharp distal tip of theelongate member26 may facilitate insertion through the patient's skin. In other embodiments, the tip of theelongate member26 may not be sharp enough, or the distal section of theelongate member26 may 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 thecatheter61ais placed inside the patient, thesheath62amay be advanced distally over thecatheter61a. Alternatively, both thecatheter61aand thesheath62amay be advanced simultaneously to enter into the patient.

Once thecatheter61aand thesheath62aare inserted into the patient, they can be driven to advance through the vasculature of the patient. At sections of thevessel2000 that are relatively straight, both thecatheter61aand thesheath62amay be driven so that they move as one unit. Occasionally, thecatheter61aand/or thesheath62amay reach a section of thevessel2000 that has a bend (e.g., a sharp bend). In such cases, thecatheter61aand thesheath62amay be driven in a telescopic manner to advance past the bend.

FIGS. 23A-23B illustrate such telescopic technique for advancing thesheath62aand thecatheter61aover abend2002 along a length of thevessel2000. In this technique, thecatheter61ais positioned with its distal articulation section traversing thebend2002 and it is locked in this position (FIG. 23A). Next, thesheath62ais advanced over thecatheter61a(FIG. 23B), and thecatheter61aacts as a rail held in a fixed shape for thesheath62ato glide over. As thesheath62ais advanced further, sections with higher bending stiffness on thesheath62awill pass over the articulated section of thecatheter61a, putting an increase load on thecatheter61a. The increase in load on thecatheter61amay tend to straighten thecatheter61a. In some embodiments, the drive assembly of therobotic system10 maintains the bent shape of thecatheter61aby tightening the control wire(s), which has the effect of stiffening thecatheter61a. In some embodiments, therobotic system10 is configured to detect the increased load on the control wires (due to the placement of thesheath62aover thecatheter61a) to be detected. The operator, or therobotic system10, can then apply an equal counteracting load on all the control wires of thecatheter61ato ensure that its bent shape is maintained while thesheath62ais advanced over the bend. In other embodiments, thesheath62amay be extremely flexible so that it does not put any significant load on thecatheter61aas thesheath62ais advanced over thecatheter61a, and/or distort the anatomy.

Once the distal end of thecatheter61areaches the target location (FIG. 23C), the distal end of thecatheter61amay be steered to create a bend so that the distal opening at thecatheter61afaces towards atissue2010 that is desired to be treated (FIG. 23D). The steering of the distal end of thecatheter61amay be accomplished by receiving a user input at theworkstation2, 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 thecatheter61ato thereby bend the distal end of thecatheter61aat the desired direction.

Next, thedistal end2300 of theelongate member26 is deployed out of the lumen of thecatheter61aby advancing theelongate member26 distally (FIG. 23E). This may be accomplished robotically using themanipulator24, and/or manually. The sharp distal tip of theelongate member26 allows thedistal end2300 to penetrate into thetarget tissue2010. Also, theflexible section320 of theelongate member26 allows theelongate member26 to follow the curvature of thecatheter61aas theelongate member26 is advanced out of the lumen of thecatheter61a.In some embodiments, the distal advancement of theelongate member26 may be accomplished by receiving a user input at theworkstation2, 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 theelongate member manipulator24 to turn its roller(s) to thereby advance theelongate member26 distally.

After thedistal end2300 of theelongate member26 is desirably positioned, the RF generator350 is then activated to cause thedistal end2300 to deliver RF ablation energy to treat thetarget tissue2010. In some embodiments, if thesystem10 includes the return electrode352 that is placed on the patient's skin, thesystem10 then delivers the energy in a monopolar configuration. In other embodiments, if theelongate member26 includes the two electrodes370a,370b,thesystem10 may then deliver the energy in a bipolar configuration. The energy is delivered to thetarget tissue2010 for a certain duration until alesion2020 is created at the target site (FIG. 23E).

In some embodiments, while energy is being delivered by theelongate member26, cooling fluid may be delivered to the target site through the lumen in theelongate member26, and out of thedistal port310 and/or side port(s)312 at theelongate member26. The cooling fluid allows energy to be delivered to the target tissue in a desired manner so that a lesion3020 of 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 lesion3020 has been created, theelongate member26 may be removed from thecatheter61a,and asubstance2030 may then be delivered to the target site through the lumen of thecatheter61a(FIG. 23F). In some embodiments, the removal of theelongate member26 from thecatheter61amay be accomplished by receiving a user input at theworkstation2, 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 theelongate member manipulator24 to turn its roller(s) to thereby retract theelongate member26 proximally until the entireelongate member26 is out of the lumen of thecatheter61a.

In some embodiments, thesubstance2030 may be an embolic material for blocking supply of blood to the target site. In other embodiments, thesubstance2030 may be a drug, such as a chemotherapy drug, for further treating tissue at the target site. In further embodiments, thesubstance2030 may 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 thesubstance2030 may be optional, and the method may not include the act of delivering thesubstance2030.

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 thecatheter61amay be steered to point to another direction, and theelongate member26 may be deployed out of thecatheter61aagain to ablate the second tumor. Also, in other embodiments, thecatheter61amay be moved distally or retracted proximally along the length of thevessel2000 to reach different target sites.

In other embodiments, instead of the telescopic configuration, therobotic system10 may be configured to drive thecatheter61aand thesheath62ain other configurations. For example, in some embodiments, thesheath62amay be bent and acts as guide for directing thecatheter61ato move in a certain direction. In such cases, therobotic system10 may be configured to relax the wires in thecatheter61aso that thecatheter61ais flexible as it is advanced distally inside the lumen of thesheath62a.Also, in other embodiments, thesheath62amay not be involved in the method. In such cases, therobotic system10 may be configured to drive thecatheter61awithout thesheath62ato advance thecatheter61athrough the vasculature of the patient.

Also, in other embodiments, a guidewire may be used in combination with thecatheter61aand/or thesheath62afor advancement of thecatheter61aand/or thesheath62ainside the vessel of the patient. In such cases, theelongate member26 is not inserted into thecatheter61a. Instead, the guidewire is coupled to theelongate member manipulator24, and the guidewire is placed inside the lumen of thecatheter61a.Themanipulator24 may then be used to drive the guidewire to advance and/or retract the guidewire. In some cases, therobotic system10 may advance the guidewire, thecatheter61a, and thesheath62ain 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 theelongate member26. For example, in some embodiments, the guidewire may be exchanged for theelongate member26 after initial access of the main hepatic artery (or vein). After the distal end of thecatheter61areaches the target site, the guidewire may then be removed from the lumen of thecatheter61a,and decoupled from theelongate member manipulator24. The proximal end of theelongate member26 is coupled to theelongate member manipulator24, and theelongate member26 is then inserted into the lumen of thecatheter61a. Theelongate member manipulator24 is then used to drive theelongate member26 distally until thedistal end2300 of theelongate member26 exits out of the distal end of thecatheter61a,as similarly discussed.

In further embodiments, theelongate member26 may not be needed to treat tissue. For example, in other embodiments, after the distal end of thecatheter61ais desirably placed at a target site, thecatheter61amay 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, thecatheter61aitself 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 thecatheter61a,and the delivery device is then used to deliver the substance. In such cases, thecatheter61ais 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, 11/176,598, 12/012,795, 12/106,254, 12/507,727, 12/822,876, 12/823,012, and 12/823,032, 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 andsystem10 for 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 therobotic system10 and the above technique may allow the distal end of theelongate member26 to reach the lobus quatratus or the lobus spigelii of the liver, which may not be possible to reach by conventional ablation probe. Also, using theelongate member manipulator24 to position theelongate member26 is advantageous because it allows accurate positioning of thedistal end2300 of theelongate 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 thecatheter61a(leader) is placed at a desired position inside the patient, thecatheter61aand theelongate member26 may be removed, leaving the sheath61bto provide a conduit for delivery of any device or substance. In another implementation, theelongate member26 may be removed, leaving thecatheter61ato provide a conduit for delivery of any device or substance. In further embodiments, theelongate member26 itself may be used to deliver any device or substance.

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 thecatheter61aand 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 thecatheter61amay be advanced first, and then followed by thecatheter61a,and then the sheath61b,in order to advance thecatheter61aand the sheath61bdistally past a curved (e.g., a tight curved) passage way. Once a target location is reached, the guidewire may be removed from thecatheter61a, and theelongate member26 may optionally be inserted into the lumen of thecatheter61a. Theelongate member26 is then advanced distally until its distal exits from the distal opening at thecatheter61a. In other embodiments, thecatheter61amay be advanced first, and then followed by the sheath61b,in order to advance thecatheter61aand 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 thecatheter61athe sheath61b(i.e., simultaneously), in order to advance thecatheter61aand 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.

Reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms “a,” “an,” “said” and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art in the field of this application.

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.

Claims

1. A medical robotic system, comprising:

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, the first rotary member rotatable relative to the base and at least a part of the first rotary member is located in the first opening of the base; 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.

2. The medical robotic system ofclaim 1, wherein the base has a second opening, and the system further comprises a second rotary member that is at least partially located in the opening.

3. The medical robotic system ofclaim 1, further comprising the component, wherein the component comprises an instrument driver configured for actuating the first rotary member when the first end of the first rotary member is coupled to the instrument driver.

4. The medical robotic system ofclaim 3, wherein the instrument driver is configured to actuate the first rotary member in response to a command signal received from a user interface.

5. The medical robotic system ofclaim 3, wherein the instrument driver comprises an actuatable member for actuating the first rotary member, and a sensor for sensing a characteristic that corresponds with an amount of force or torque being applied to the actuatable member.

6. The medical robotic system ofclaim 5, wherein the sensor comprises a force sensor.

7. The medical robotic system ofclaim 1, wherein the first end of the first rotary member comprises a slot for mating with an actuatable member of the component.

8. The medical robotic system ofclaim 1, wherein the first end of the first rotary member comprises a protrusion for mating with an actuatable member of the component.

9. The medical robotic system ofclaim 1, wherein the base, the first rotary member, and the cover are respective parts of a sterile adaptor, the sterile adaptor further comprising a flexible sheet coupled to the base.

10. The medical robotic system ofclaim 9, wherein the cover has a first opening sized and configured for allowing the second end of the first rotary member to extend therethrough when the first rotary member is coupled to the component.

11. The medical robotic system ofclaim 9, further comprising:

a splayer assembly having a first splayer rotary member; and

an instrument driver,

wherein the second end of the first rotary member is configured to detachably couple to the first splayer rotary member, and the first end of the first rotary member is configured to detachably couple to the instrument driver.

12. The medical robotic system ofclaim 11, wherein the second end of the first rotary member extends through an opening at the cover, and comprises a plurality of keys configured for mating with corresponding slots in the first splayer rotary member.

13. The medical robotic system ofclaim 11, wherein when the first rotary member of the sterile adaptor is coupled to the first slayer rotary member, the instrument driver is configured to actuate the first rotary member in response to a command signal received from a user interface to thereby rotate the first splayer rotary member.

14. The medical robotic system ofclaim 1, wherein the base has a second protrusion, and the flange has a second circumferential slot for receiving the second protrusion.

15. A medical robotic system, comprising:

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.

16. The medical robotic system ofclaim 15, wherein

the base comprises a protrusion next to the first opening; and

the rotary member comprises a first end, a second end, a body extending between the first and second ends, and a flange disposed circumferentially around at least a portion of the body, the flange having a first circumferential slot for receiving the protrusion.

17. The medical robotic system ofclaim 16, wherein the base has a second protrusion, and the flange has a second circumferential slot for receiving the second protrusion.

18. The medical robotic system ofclaim 15, wherein the sensor comprises a force sensor.

19. The medical robotic system ofclaim 15, wherein the rotary member has a slotted end configured for mating with the actuatable member of the instrument driver.

20. The medical robotic system ofclaim 15, wherein the rotary member comprises a protrusion configured for mating with the actuatable member of the instrument driver.

21. The medical robotic system ofclaim 15, wherein the base and the rotary member are respective parts of a sterile adaptor, the sterile adaptor further comprising a flexible sheet coupled to the base.

22. The medical robotic system ofclaim 21, further comprising a splayer assembly having a splayer rotary member, wherein the rotary member has a first end configured for detachably coupling to the actuatable element of the instrument driver, and a second end configured for detachably coupling to the splayer rotary member.

23. The medical robotic system ofclaim 22, wherein the second end of the rotary member comprises a plurality of keys configured for mating with corresponding slots in the splayer rotary member.

24. The medical robotic system ofclaim 22, wherein when the sterile adaptor rotary member is coupled to the splayer rotary member and to the actuatable element, the instrument driver is configured to actuate the actuatable element to thereby indirectly rotate the splayer rotary member through the sterile adaptor rotary member.

25. The medical robotic system ofclaim 22, wherein the splayer assembly further comprises:

an elongate member having a distal end, a proximal end, and a lumen extending between the distal and proximal ends of the elongate member; and

a first control wire having a distal end coupled to the distal end of the elongate member, and a proximal end coupled to the splayer rotary member.

26. A method of steering a distal end of an elongate member, comprising:

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.

27. The method ofclaim 26, wherein the act of using the actuatable element to apply the torque comprises increasing the amount of force or torque being applied by the actuatable element until the sensed characteristic indicates that the amount of tension at the steering wire has been achieved.

28. The method ofclaim 26, wherein the sensor is coupled indirectly to the actuatable element through a mechanical component.