Espacenet - Bibliographic data
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`https://worldwide.espacenet.com/publicationDetails/biblio?CC
`
`EP&NR=2124800B1&KC...
`
`1/25/2022
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`
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`

`

`Espacenet - Bibliographic data
`
`https://worldwide.espacenet.com/publicationDetails/biblio?CC=EP&NR=2124800B1&KC...
`
`1/25/2022
`
`

`

`(9)|= OMIANOC
`
`European
`Patent Office
`desbrevets
`(11)
`EP 2 124 800 B1
`
`
`
`(12)
`
`EUROPEAN PATENTSPECIFICATION
`
`(45) Date of publication and mention
`of the grantof the patent:
`17.11.2010 Bulletin 2010/46
`
`(21) Application number: 08730065.3
`
`(22) Date offiling: 15.02.2008
`
`(51) Int CL:
`AG1B 19/00 (2006.01)
`
`A61M 25/01 2006.91)
`
`(86) International application number:
`PCT/US2008/0541 85
`
`(87) International publication number:
`WO 2008/101228 (21.08.2008 Gazette 2008/34)
`
`(54) ROBOTIC MEDICAL INSTRUMENT SYSTEM
`MEDIZINISCHES ROBOTERINSTRUMENTENSYSTEM
`
`SYSTEME D’INSTRUMENT MEDICAL ROBOTISE
`
`(84) Designated Contracting States:
`AT BE BG CH CY CZ DE DK EE ES FIFR GB GR
`HR HUIE IS IT LILT LU LV MC MT NL NO PL PT
`RO SE SISK TR
`
`(30) Priority: 15.02.2007 US 902144 P
`25.05.2007 US 931827 P
`15.06.2007 US 934639 P
`
`(43) Date of publication of application:
`02.12.2009 Bulletin 2009/49
`
`(73) Proprietor: Hansen Medical, Inc.
`Mountain View, California 94043-5207 (US)
`
`(72) Inventors:
`¢ STAHLER, Gregory, J.
`San Jose, California 95117 (US)
`¢ WALLACE, Daniel, T.
`Burlingame,California 94010 (US)
`¢ SALISBURY, J., Kenneth
`Cambridge, Massachusetts 02140 (US)
`
`(74) Representative: Lecomte, Didier
`Lecomte & Partners Sarl
`B.P. 1623
`
`1016 Luxembourg (LU)
`
`(56) Referencescited:
`WO-A-2005/117688
`US-A1- 2006 084945
`
`US-A1- 2002 087 049
` US-A1- 2006 229 587
`
`
`
`EP2124800B1
`
`Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent
`Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the
`Implementing Regulations. Notice of opposition shall not be deemedto have been filed until the opposition fee has been
`paid. (Art. 99(1) European Patent Convention).
`
`Printed by Jouve, 75001 PARIS (FR)
`
`

`

`Description
`
`EP 2 124 800 B1
`
`to flexible catheter instruments for
`[0001] The invention relates generally to surgical tools, and more particularly,
`performing minimally invasive diagnostic and therapeutic procedures with a robotic catheter system.
`
`BACKGROUND
`
`[0002] Robotic interventional systems and devices are well suited for use in performing minimally invasive medical
`procedures as opposed to conventional procedures that involve opening the patient’s body to permit the surgeon’s hands
`to access internal organs. Traditionally, surgery utilizing conventional procedures meantsignificant pain, long recovery
`times, lengthy work absences, and visible scarring. However, advances in technology have leadto significant changes
`in the field of medical surgery such that less invasive surgical procedures are increasingly popular, in particular, minimally
`invasive surgery (MIS). A "minimally invasive medical procedure”is generally a procedure that is performed by entering
`the body through the skin, a body cavity, oran anatomical opening utilizing small incisions rather than large open incisions
`in the body. Various medical procedures are considered to be minimally invasive including, for example, mitral and
`tricuspid valve procedures, patent formen ovale, atrial septal defect surgery, colon and rectal surgery, laparoscopic
`appendectomy, laparoscopic esophagectomy, laparoscopic hysterectomies, carotid angioplasty, vertebroplasty, endo-
`scopic sinus surgery, thoracic surgery, donor nephrectomy, hypodermicinjection, air-pressure injection, subdermal
`implants, endoscopy, percutaneous surgery, laparoscopic surgery, arthroscopic surgery, cryosurgery, microsurgery,
`biopsies, videoscope procedures, keyhole surgery, endovascular surgery, coronary catheterization, permanent spinal
`and brain electrodes, stereotactic surgery, and radioactivity-based medical imaging methods. With MIS, it is possible to
`achieve less operative trauma for the patient, reduced hospitalization time, less pain and scarring, reduced incidence
`of complications related to surgical trauma, lower costs, and a speedier recovery.
`[0003]
`Special medical equipment may be used to perform minimally invasive procedures. Typically, a surgeon inserts
`small tubes or ports into a patient and uses endoscopesor laparoscopes having a fiber optic camera, light source, or
`miniaturized surgical instruments. Without a traditional large and invasive incision, the surgeon is not able to see directly
`into the patient. Thus, the video camera serves as the surgeon’s eyes. The images of the interior of the body are
`transmitted to an external video monitor to allow la surgeon to analyze the images, make a diagnosis, visually identify
`internal features, and perform surgical procedures based on the images presented on the monitor.
`[0004] Minimally invasive procedures may involve minor surgery as well as more complex operations that involve
`robotic and computer technologies, which may be used during more complex surgical procedures and have led to
`improved visual magnification, electromechanical stabilization, and reduced number of incisions. The integration of
`robotic technologies with surgeon skill into surgical robotics enables surgeons to perform surgical procedures in new
`and more effective ways.
`[0005] Although minimally invasive surgical techniques have advanced, physical limitations of certain types of medical
`equipmentstill have shortcomings and can be improved. For example, during a minimally invasive medical procedure,
`catheters, endoscopes or laparoscopes maybeinserted into a body cavity duct or vessel. A catheter is an elongated
`tube that may, for example, allow for drainage orinjection of fluids or provide a path for delivery of working or surgical
`instruments to a surgical or treatment site. Such devices, however, may haverigid shafts and lack flexibility along their
`lengths. As aresult, they lack the required or desired degrees of freedom and range of controllable motion. These issues
`may be particularly relevant in procedures involving routing of surgical devices around a number of turns or bends.
`Consequently, contro! of a tool or working instrument at the distal tip of an instrument that has traversed a number of
`curves maybe difficult with known devices, thereby resulting in more complicated and/or less effective procedures.
`[0006] US 2006/0084945 discloses a device according to the preamble of appended claim 1.
`[0007] Accordingly, robotic interventional systems, devices and related procedures can be improved to provide en-
`hanced rebotic controls, maneuverability and positioning of controllable surgical instruments.
`
`SUMMARY
`
`[0008] According to the invention as defined in appended claim 1, an instrument driver operable to control coaxially
`aligned elongate catheter instruments in response to control signals generated by an input device comprises a frame
`and first and second carriages. The first carriage is movably coupled to the frame and configured te support a first
`catheter instrument, and the second carriage is movably coupled to the frame and configured to support a second
`catheter instrument. The first and second carriagesare independently rotatable about a longitudinal axis of the respective
`first and second catheter instruments.
`
`[0009] According to another embodiment, an instrument driver operable to control coaxially aligned elongate catheter
`instruments in response to control signals generated by an input device, the instrument driver comprises a frame and
`first and second carriages. The first carriage is movably coupled to the frame and configured to support a first catheter
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`EP 2 124 800 B1
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`instrument. The second carriage is movably coupled to the frame and configured to support asecond catheter instrument.
`The first and second carriages are independently movable in at least three different directions with at least two different
`types of motion.
`[0010]
`Inafurther embodiment, a robotic medical system comprises an input device, first and second elongate catheter
`instruments, and an instrumentdriver. The input device is configured to generate control signals in response to user
`input. The first and second elongate catheter instruments are coaxially aligned. The instrument driver is operable to
`control the first and second catheter instruments in response to control signals generated by the input device. The
`instrument driver comprises a frame, a first carriage movably coupled to the frame and configured to support a first
`catheter instrument, and a second carriage movably coupled to the frame and configured to support a second catheter
`instrument. The first and second carriages are independently rotatable about a longitudinal axis of the respectivefirst
`and second catheter instruments.
`
`In one or more embcdiments, the first carriage is positioned relative to the second carriage such thatthe first
`[0011]
`catheter instrument coupled to the first carriage may be positioned within a lumen of a second catheter instrument
`coupled to the second carriage. The first and second carriages may also be positioned within the frame suchthat
`respective longitudinal axesof the first and second catheter instruments are aligned with a longitudinal axis of the frame.
`[0012]
`Further, in one or more embodiments, the first and second carriages are independently and simultaneously
`rotatable about a longitudinal axis of the frame. The first and second carriages may also be rotatable in different directions
`about a longitudinal axis of the frame. The frame mayalso be rotatable, and the first and second carriages are inde-
`pendently rotatable relative to each other and to the frame when the frame is rotated. Independentcarriage rotation can
`be implemented by use of respective drive elements that are controllable to rotate the respective carriage relative to the
`frame.
`
`In another configuration, the disclosure is directed to a robotic medical instrument system that comprises an
`[0013]
`elongate catheter body and a catheter drive shaft. The catheter body includes proximal and distal ends, has longitudinal
`axis, and defines a lumen. The catheter drive shaft is positioned within the catheter body lumen. An inner surface of the
`catheter body distal end and an outer surface of a distal end of the catheter drive shaft are operatively coupled such
`that axial displacement of the catheter drive shaft relative to the catheter body causes a corresponding rotation of one
`of the drive shaft and catheter body relative to the other.
`[0014] The distal end of the catheter drive shaft may be controllably extendable out of, and controllably retractable
`into, a distal end opening of the catheter body in communication with the catheter body lumen. Further, the outer surface
`of the distal end of the catheter drive shaft and the inner surface ofthe distal end of the catheter body have complimentary
`threaded surfaces or form a BNC connector.
`
`[0015] A further configuration is directed to a robotic medical instrument system that comprises an elongate catheter,
`an actuation element and a control element. The catheter body includes a proximal end and a controllable distal end.
`The catheter body further includes a longitudinal axis and defines a lumen. The actuation elementis positioned within
`the catheter body lumen and coupled to an internal portion of the catheter body, e.g., a distal segment of the catheter.
`The control element extends through the catheter body, and the actuation element and the catheter body are rotatable
`together in response to manipulation of the control element.
`[0016] The actuation element mayinclude a gear, a guide anda pin. The gear includes teeth defining corresponding
`grooves, and the guide is disposed on an inner surface of the distal end of the catheter body adjacent to the gear. For
`example, the guide may havea triangular shape and be formedwithin an inner surface of the catheter body distal end.
`The pin is movable along the guide. Acontrol elementis attached to the pin such that manipulation of the control element
`results in movement of the pin along the guide and within the groove to rotate the actuation element and the catheter
`body. The pin may be movable in multiple directions along the guide in response to manipulation of the control element.
`Further, the pin may traverse a guide surface that is non-uniform such that the pin is positionable at different depths as
`the pin traverses the guide surface.
`[0017] Another alternative configuration is directed to a robotic medical instrument system that includes an elongate
`catheter body, first and second actuation elements and first and second control elements. The elongate catheter body
`has a proximal end and a controllable distal end. The catheter body has a longitudinal axis and defines a lumen. The
`first actuation elementis positioned within the catheter body lumen and is coupled to an internal portion of the catheter
`body, and the second actuation elementis positioned within the catheter body lumen distal to the first internal actuation
`element and coupled to an internal portion of the catheter body. The first control element extends through the catheter
`body lumen and is coupled to the first actuation element, and the second control element extends through the catheter
`body lumen and is coupled to the second actuation element. At least one of the first and second actuation elements and
`the catheter body are rotatable together in response to manipulation of at least one of the first and second control
`elements. The first and second actuation elements mayrotate in opposite directions.
`[0018] According to yet another configuration, a robotic medical instrument system comprises an elongate catheter
`body anda harmonic drive element. The catheter body includes a proximal end, acontrollable distal end and alongitudinal
`axis. The harmonic drive elementis located at the distal end of the catheter body and operable to generate a harmonic
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`EP 2 124 800 B1
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`signal to thereby rotate the distal end of the catheter body
`[0019] The harmonic drive element mayinclude a harmonic wave generator having an elliptically shaped and rotatable
`element, a flexible spline, the wave generator being positioned within a bore of the flexible spine to impart an elliptical
`shape to the flexible spline, and an outer circular spline. The elliptically shaped flexible spline is positioned within a bore
`of the circular spine. An outer surface of the flexible spline rotatably engages an inner surface of the circular spline at
`opposite locations due to the elliptical shape imparted to the flexible spline by the wave generator. The flexible spline is
`rotatable within the circular spine to generate a harmonic signal that rotates the distal end of the catheter body. The
`circular spine is also rotatable to generate a harmonic signal that rotates the distal end of the catheter body. Alternatively,
`the flexible spline may be fixed relative to the circular spline.
`[0020] A further configuration is directed to a robotic medical instrument system that comprises an elongate catheter
`body anda wobble plate drive element. The catheter body has a proximal end and a controllable distal end. The catheter
`body has a longitudinal axis and defines a lumen. The wobble plate drive element is located at the distal end of the
`catheter body and is operable to rotate the distal end of the catheter body.
`[0021]
`In one embodiment, the wobble plate drive element is operable to rotate the distal end of the catheter body
`based on differential rotation of different gear elements of the wobble plate drive element. In one embodiment, the wobble
`plate drive element comprises a rotatable shaft, a first, stationary gear element, a second gear element coaxial with the
`shaft and rotatable aboutthe first gear element plate and around the shaft, a tension element disposed between the first
`and second gear elements, the tension element urging the second gear element away from the first gear element, and
`a drive element configured to rotate the second gear element to urge a portion of the second gear element, against the
`force of the spring, to engagea portion of the first gear element, while an opposite portion of the second gear element
`does not engage the first gear element. Further, in another embodiment, the drive element comprises a plurality of
`control elements attached to different sections of the second gear element. The plurality of control elements can be
`manipulated to urge a portion of the second gear element to engage a portion of the first gear element. The drive element
`may also include a rotatable arm that extends from the shaft and engaging a top surface of the second gear element to
`urge a portion of the second gear element, against the force of the spring, to engage a portion of the first gear element.
`Thus, the location at which the second gear element engagesthe first gear element changes asthe rotatable arm is rotated.
`[0022]
`In yet another alternative configuration, a robotic medical instrument system comprises an elongate catheter
`and a planetary gear drive element. The elongate catheter body has a proximal end, a controllable distal end, and a
`longitudinal axis, and defines a lumen.
`[0023] The planetary gear drive elementis located at the distal end of the catheter body and is operable to rotate the
`distal end of the catheter body. The planetary gear drive element can include an outer ring gear, a central gear, and a
`plurality of intermediate gears rotatably engaged betweenthe outer ring gear and the central gear.
`[0024]
`In one or more configuration, a control cable extends through a lumen of the catheter drive shaft to a working
`instrument coupled to a distal end of the catheter drive shaft.
`[0025] According to yet another configuration, a robotic medical instrument system comprises an elongate catheter
`body and an elongate, flexible support structure that extends through a lumen of the catheter body. The catheter body
`has flexible distal segment, and the flexible support structure comprises a plurality of substantially spherical elements
`and a plurality of non-spherical elements.
`[0026] According to another configuration, a robotic medical instrument system comprises an elongate catheter body,
`an elongate, flexible support structure, and a control element. The catheter body has a controllable and flexible distal
`end, anda lumen extending longitudinally through the catheter body. The support structure extends through the catheter
`body lumen and comprises a seriesof alternating substantially spherical and non-spherical elements. The control element
`extends through the catheter body. Bending of the respective catheter body and the flexible support structure are
`controllable by manipulation of the control element.
`[0027] A further alternative configuration is directed to a robotic medical instrument system that comprises an elongate
`catheter body, an elongate, flexible support structure, an interface, and a control element. The catheter body has a
`proximal end, a controllable and flexible distal end, and a lumen extending longitudinally through the catheter body. The
`support structure extends through the catheter body lumen and comprisesa series of alternating substantially spherical
`elements and non-spherical elements. The interface is coupled to the distal end of the catheter body for controlling an
`orientation of a working instrument. The interface includes a base member coupled to the distal end of the catheter body,
`a spacer element, and a platform member. The spacer element is retained between and separates the base member
`and the platform member. The contro! element extends through the flexible catheter, through an aperture defined by the
`base member, andterminatesat the platform member. Bending of the respective catheter body andthe support structure,
`an orientation of the platform member, and an orientation of the working instrument are each controllable by manipulation
`of the control element.
`
`In one or more configuration, the non-spherical elements comprise cylindrical elements, and the support struc-
`[0028]
`ture may comprise a series of alternating substantially spherical elements and non-spherical elements. Respective
`substantially spherical elements are seated and movable within indentations or concave cavities of respective adjacent
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`EP 2 124 800 B1
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`non-spherical elements.
`[0029]
`Inoneormore configurations, the support structure is bendable with the catheter body lumen, andthe respective
`substantially spherical and non-spherical elements (e.g. cylindrical elements) collectively define a central, inner lumen.
`Further, in one or more embodiments, respective substantially spherical elements are seated and movable within in-
`dentations or concave cavities of respective adjacent non-spherical members. Additionally, in one or more embodiments,
`a plurality of control elements extend through the catheter body and terminate at the platform member. Bending of the
`catheter body, bending of the support structure, an orientation of the platform member, and an orientation of the working
`instrument are each controllable by manipulation of one or more of the plurality of control elements.
`[0030]
`In one or more configurations, a spacer element has a substantially spherical shape. Further, in one or more
`embodiments, a base member is fixed to the distal end of the catheter body, and the platform member is pivotable about
`the spacer element. Further, the base member and the platform member may each define a respective indentation or
`concave cavity occupied by the spacer element. An adapter mayalso be utilized to couple a working instrument to the
`platform members.
`[0031] According to another configuration, an interface assembly for controlling an orientation of a working instrument
`of a robotic medical instrument system comprises a base member, a platform member, a spacer element, and a control
`element. The base member is coupled to a distal end of an elongate instrumentof the robotic medical instrument system.
`The spacer elementis retained between the base member and the platform member, which is movable relative to the
`base member about the spacer element. The control element extends through an aperture defined by the base member
`and between the base and platform members. An orientation of the platform member and an orientation of the working
`instrument are controllably adjustable by manipulation of the control element.
`[0032] According to yet another configuration, an interface assembly for controlling an orientation of a working instru-
`mentof a robotic medical instrument system comprises a base member, a platform member, a spacer element and a
`control element. The base member is coupled to a distal end of an elongate instrumentof the robotic medical instrument
`system. The spacer element is retained between the base member and the platform member, which is movable relative
`to the base member about the spacer element. The control element extends through an aperture defined by the base
`member and between the base member and the platform member at an angle, which is defined between longitudinal
`axes of the control element and the base member. An orientation of the platform member and an orientation of the
`working instrument are controllably adjustable by manipulation of the control element.
`[0033]
`In accordancewith a further alternative configuration, a multi-level interface assembly for controlling an orien-
`tation of a working instrument of a robotic medical instrument system comprises a base member, spacer elements,
`platform members and a control element. The base member coupled to a distal end of an elongate instrumentof the
`robotic medical instrument system. The first spacer element is retained between the base member and a proximal
`platform member, and the second spacer elementis retained between the proximal platform member andadistal platform
`member, which is movable relative to the base member about the second spacer element. The control element extends
`through an aperture defined by the base member and between the base member and the distal platform member. An
`orientation of the distal platform member and an orientation of the working instrument are controllably adjustable by
`manipulation of the control element.
`[0034]
`In one or more configurations, the base member is fixed or stationary, and the platform member is pivotable
`about the spacer element. Further, in one or more configurations, each of the base member and the platform member
`defines a concave cavity in which the spacer element, which may be spherical, is positioned. Assembly components
`may also define a lumen such that the collection of assembly component lumens defines a central lumen that in com-
`munication with a lumen of the elongate instrument, which may be a robotically controlled catheter.
`[0035]
`Further, in one or more configurations an assembly includesa plurality of control elements that extend through
`respective apertures defined by the base member and terminate at the platform member. Orientations of the platform
`member and the working instrument, which may be coupled to the platform member via an adapter, are controllably
`adjustable by manipulation of one or more control elements assuming biasing forces of springs extending between the
`base and platform members are overcome. Further, control element manipulation may be used to control an orientation
`of the distal end of the elongate instrument.
`[0036]
`In one or more configurations, control elements terminate at the platform member. Control elements may also
`be oriented at an angle relative to a longitudinal axis of the base member, such as an angle of at least 30 degrees. Two
`or more control elements may also overlap or cross eachother,e.g., if they extend through misaligned apertures defined
`by the base member and the platform member at an angle in casesin which a control element extends through a platform
`member aperture. Angled of off-axis control element arrangements may result in a control element extending across a
`substantial width of the base member. Further, a control element may also extend through a platform member and across
`a portion of a top or distal surface of the platform member, and the, for example, back downthrough the platform member
`and through the base member.
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`BRIEF DESCRIPTION OF THE DRAWINGS
`
`EP 2 124 800 B1
`
`[0037] The foregoing arid other aspects of various configurations of the disclosure will best be appreciated with ref-
`erence to the detailed description of embodiments in conjunction with the accompanying drawings, wherein:
`
`1 illustrates an configuration of a robotic medical instrument system including a flexible instrument such as a
`Fig.
`flexible catheter;
`Figs. 2A-D illustrate configurations of a workstation and robotic medical instrument system, wherein Fig. 2Aillustrates
`an operator workstation of an configuration of the system illustrated in Fig. 1, Fig. 2B illustrates an configuration of
`an operator workstation that includes a master input device and data gloves, Fig. 2C illustrates another configuration
`of an operator workstation with which a flexible instrument control can be input using a master input device and
`wireless data gloves, and Fig. 2D is a block diagram illustrating a system architecture of one configuration of a
`robotic medical instrument system;
`Fig. 3 illustrates an configuration of a setup joint supporting an instrument driver above an operating table;
`Fig. 4A-F illustrate a setup joint constructed according to one configuration, wherein Fig. 4A is a rear perspective
`view of one embodimentof a setup joint having an instrument driver mounted thereto, Fig. 4B illustrates the setup
`joint separately from the instrument driver, Fig. 4C is another perspective view of the setup joint shownin Fig. 4B,
`Fig. 4D is a rearward perspective view of an assembly including a mounting plate and locking lever, and Fig. 4E is
`a forward perspective view of the assembly shownin Fig. 4D and showing front and top portions of the instrument
`driver, and Fig. 4F illustrates a setup joint mounted to a patient bed;
`Fig. 4G-J illustrate other configurations of a setup joint, wherein Figs. 4G-H illustrate a setup joint configured to
`support a pair of instrumentdrivers, and Figs. 41-Jillustrate a setup joint configured to supportthree instrumentdrivers;
`Fig. 5A-D illustrate an arrangementfor controlling a robotic medical instrument using an instrument driver, wherein
`Fig. 5A is a forward perspective view of one configuration an instrument driver having a flexible instrument assembly
`mounted thereon, Fig. 5B is a rear perspective view of the arrangement shownin Fig. 5A, Fig. 5C is a forward
`perspective view of the arrangement shownin Figs. 5A-B, and Fig. 5D is a rear perspective view of the arrangement;
`Figs. 5E-L illustrate an embodimentof an instrument driver according to the invention for controlling a robotic medical
`instrument and including independently rotatable carriages, wherein Figs. 5E-F are cross-sectional side viewsillus-
`trating positioning and axial motion of carriages, Figs. 5G-H are rear views of the instrumentdriver shown in Figs.
`5E-F and that show independentcarriage rotation, Fig. 5I is a perspective view of an instrument driver having
`independently rotatable carriages, and Fig. 5J illustrates one embodiment of a gear arrangementfor rotating a
`carriage;
`Fig. 5K is a top view of an embodimentof an instrument driver that includes independently rotatable carriages, and
`Fig. 5L is a side elevation view of the arrangement shownin Fig. 5K;
`Figs. 6A-E illustrate embodiments of a flexible catheter assembly, wherein Fig. 6A is a forward perspective view of
`catheter assembly, Fig. 6B is a rear perspective view of Fig. 6A, Fig. 6C illustrates a flexible sheath instrument, and
`Fig. 6D illustrates a flexible catheter instrument, and Fig. 6E illustrates an embodimentof a flexible catheter assembly
`having splayers with their housings removed to show their control knobs;
`Figs. 7A-D illustrate embodiments of a flexible catheter having instrument members with varying degreesofflexibility,
`wherein Fig. 7Aillustrates a catheter having a flexible distal end, Fig. 7B illustrates a catheter having a flexible distal
`end and flexible segment disposed between rigid segments, Fig. 7C illustrates a catheter having a rigid proximal
`segment, a flexible medial segment, and a flexible distal segment, and Fig. 7D illustrates a catheter having a flexible
`proximal segment and a flexible distal segment;
`Figs. 8A-F illustrate a configuration of a flexible catheter assembly having various degrees of freedom;
`Figs. 9A-9G illustrate further embodiments of a flexible catheter having various degrees of freedom, and Figs. 9B-
`G are cross sectional views along line A-A in Fig. 9Aillustrating different opening shapes;
`Figs. 10A-C illustrate flexible catheter constructed according to configurations and having coil, braid and skeletal
`hinge spine or support structures;
`Figs. 11A-B illustrate a flexible catheter constructed according to one configuration having aspine orsupport structure
`including a series of alternating spherical and cylindrical elements;
`Figs. 12A-B illustrate a flexible catheter constructed according to another configuration that includes pivoting skeletal
`rings;
`Figs. 13A-B illustrate another embodimentof a flexible catheter that includes a support spine including pivoting
`skeletal