Patent Description:
Minimally invasive medical techniques are intended to reduce the amount of tissue that is damaged during interventional procedures, thereby reducing patient recovery time, discomfort, and deleterious side effects. Such minimally invasive techniques may be performed through natural orifices in a patient anatomy or through one or more surgical incisions. Through these natural orifices or incisions clinicians may insert interventional instruments (including surgical, diagnostic, therapeutic, or biopsy instruments) to reach a target tissue location. To reach the target tissue location, a minimally invasive interventional instrument may navigate natural or surgically created passageways in anatomical systems such as the lungs, the colon, the intestines, the kidneys, the heart, the circulatory system, or the like. Current interventional instruments are either manually controlled or robotically controlled. In manually controlled systems, a clinician controls the insertion of the interventional instrument and the manipulation of the distal end of the interventional instrument in one or more degrees of freedom. Manually controlled systems rely primarily upon the clinician to navigate a complex network of anatomical passageways to reach a procedure location. Robotically controlled interventional instruments allow a remote user to use advanced imaging and navigation techniques to robotically control the interventional instrument. With robotically controlled systems, the insertion of the instrument and/ or movement of the distal end of the surgical instrument in one or more of degrees of freedom may be operated with robotic control. For certain complex interventional procedures, clinicians may prefer a hybrid approach, in which a single interventional instrument may be operated with manual control for a portion of the procedure and with robotic control for other portions of the procedure. Improved systems and methods are needed for providing manual and robotic control to a common interventional instrument.

<CIT> discloses a hybrid surgical operation robot system and a control method thereof to enable a user to perform an operation by adding a handle for the manipulation of a robot. An instrument is installed to a robot arm. A handle for the manipulation is combined with the instrument. The instrument executes an operation which is required for a surgical operation by the manipulation of a user. A driving part is installed in the leading end part of the robot arm. The driving part is operated by using a driving force transferred from the robot arm. A shaft is combined with the driving part. A power transmission part, which is connected to the driving part, is stored inside the shaft. An effector is combined with the end part of the shaft. The effector is operated by the driving force transferred among the robot arm and the handle.

<CIT> discloses an instrument having a flexible and elongated body including at least a lumen and a flex member disposed within the lumen. The flex member may be capable of providing steering control to a first portion of the elongate body while providing load bearing support to a second portion of the elongate body. A pull wire may be disposed within the flex member, and at least a distal portion of the pull wire may be coupled to the elongate body and a proximal portion of the pull wire may be operatively coupled to a control unit. The control unit may be coupled to a proximal portion of the elongate body.

<CIT> discloses methods and devices for controlling movement of an end effector, and in particular for causing mimicked motion between an input tool and an end effector during a surgical procedure. In one disclosed system, a surgical system is provided having a master assembly with an input tool and a slave assembly with an end effector. The master assembly and the slave assembly can be coupled together by a mechanical assembly that is configured to mechanically transfer mimicked, rather than mirrored, motion from the input tool to the end effector. A floating frame is also provided and can be utilized with the surgical system. The floating frame can have a counterbalance that allows the surgical system to "float" above a patient and provide a weightless feel to movement of the surgical system. In addition, the floating frame can provide a number of additional degrees of freedom for ease of movement of the surgical system around the patient and/or the operating room.

<CIT> discloses a medical instrument including a shaft and an actuated structure mounted at a distal end of the shaft can employ a pair of tendons connected to the actuated structure, extending down the shaft, and respectively wound around a capstan in opposite directions. A preload system (<NUM>) may be coupled to maintain minimum tensions in the tendons.

<CIT> discloses a minimally invasive instrument for robotic surgery, comprising a functional element, a force, torque and/or pressure transmission device for the transfer of force, torque and/or pressure from a drive to the functional element, a coupling device for coupling the instrument to a medical robot such that the functional element can be actuated by the drive, and an operating element for manually operating the functional element in a state in which the instrument is uncoupled from the medical robot.

The present invention provides an interventional instrument as set out in the appended independent claim. Optional features are set out in the appended dependent claims. Any methods disclosed should be understood as illustrative only and are not claimed.

In one disclosed example, a system comprises a handpiece body configured to couple to a proximal end of a medical instrument and a manual actuator mounted in the handpiece body. The system further includes a plurality of drive inputs mounted in the handpiece body. The drive inputs are configured for removable engagement with a motorized drive mechanism. A first drive component is operably coupled to the manual actuator and operably coupled to one of the plurality of drive inputs. The first drive component controls movement of a distal end of the medical instrument in a first direction. A second drive component is operably coupled to the manual actuator and operably coupled to another one of the plurality of drive inputs. The second drive component controls movement of the distal end of the medical instrument in a second direction.

In another disclosed example, a method of operating a medical instrument comprises providing the medical instrument coupled to a handpiece body, a manual actuator mounted in the handpiece body, a plurality of drive inputs mounted in the handpiece body, and first and second drive components extending within the handpiece body. While the plurality of drive inputs are coupled to a motorized drive mechanism, one of the plurality of drive inputs is activated to move at least one of the first and second drive components, thereby moving a distal end of the medical instrument in a first degree of freedom. While the plurality of drive inputs are decoupled from the motorized drive mechanism, a user force is received on the manual actuator to move at least one of the first and second drive components, thereby moving the distal end of the medical instrument in the first degree of freedom.

In another disclosed example, a system comprises a handpiece body configured to couple to a proximal end of a medical instrument and a manual actuator mounted in the handpiece body. The system also comprises a motorized drive mechanism mounted in the handpiece body. A first drive component is operably coupled to the manual actuator and operably coupled to the motorized drive mechanism. The first drive component controls movement of a distal end of the medical instrument in a first direction. A second drive component is operably coupled to the manual actuator and operably coupled to the motorized drive mechanism. The second drive component controls movement of the distal end of the medical instrument in a second direction.

A method of operating a medical instrument is also described that comprises providing the medical instrument coupled to a handpiece body, a manual actuator mounted in the handpiece body, a motorized drive mechanism mounted in the handpiece body, and first and second drive components extending within the handpiece body. While the motorized drive mechanism is activated, at least one of the first and second drive components is moved, thereby moving the distal end of the medical instrument in a first degree of freedom. While the motorized drive mechanism is deactivated, a user force is received on the manual actuator to move at least one of the first and second drive components, thereby moving the distal end of the medical instrument in the first degree of freedom.

In the following detailed description of the aspects of the invention, numerous specific details are set forth in order to provide a thorough understanding of the disclosed embodiments. However, it will be obvious to one skilled in the art that the embodiments of this disclosure may be practiced without these specific details. In other instances well known methods, procedures, components, and circuits have not been described in detail so as not to unnecessarily obscure aspects of the embodiments of the invention. And, to avoid needless descriptive repetition, one or more components or actions described in accordance with one illustrative embodiment can be used or omitted as applicable from other illustrative embodiments.

The embodiments below will describe various instruments and portions of instruments in terms of their state in three-dimensional space. As used herein, the term "position" refers to the location of an object or a portion of an object in a three-dimensional space (e.g., three degrees of translational freedom along Cartesian X, Y, Z coordinates). As used herein, the term "orientation" refers to the rotational placement of an object or a portion of an object (three degrees of rotational freedom - e.g., roll, pitch, and yaw). As used herein, the term "pose" refers to the position of an object or a portion of an object in at least one degree of translational freedom and to the orientation of that object or portion of the object in at least one degree of rotational freedom (up to six total degrees of freedom). As used herein, the term "shape" refers to a set of poses, positions, or orientations measured along an elongated object.

Referring to <FIG> of the drawings, a hybrid minimally invasive interventional instrument system <NUM> utilizes aspects of the present disclosure. The system <NUM> includes a medical instrument such as a catheter system <NUM> coupled to an instrument handpiece <NUM>. The catheter system <NUM> includes an elongated flexible body <NUM> having a proximal end <NUM> and a distal end <NUM>. In one embodiment, the flexible body <NUM> has an approximately <NUM> outer diameter. Other flexible body outer diameters may be larger or smaller. In alternative embodiments, other types of medical instruments may be coupled to and actuated by the instrument handpiece. The flexible body <NUM> houses opposing drive components <NUM>, <NUM> for moving the distal end <NUM> of the flexible body in opposite directions. For example, the drive components may control opposing pitch movements or opposing yaw movements of the distal end <NUM>. In various embodiments, additional sets of opposing drive components may be included to control multiple opposing directions of motion (e.g., pitch, yaw, and roll). The drive components may include tendons, linkages, or other steering controls (not shown) that extend from the instrument handpiece <NUM> to the distal end <NUM>. Tendons are generally continuous elongated members that can withstand tension. Tendons may include multicomponent members such as helical wound or braided cables, ropes, loose fiber rovings, and fiber or wire reinforced belts. Tendons also include single component members such as wires, rods, tubes, bands, filaments or other continuous members suitable for use in tension. The flexible body <NUM> may further house control mechanisms (not shown) for operating a surgical end effector or another working distal part that is manipulable for a medical function, e.g., for effecting a predetermined treatment of a target tissue. For instance, some end effectors have a single working member such as a scalpel, a blade, a needle, an optical fiber, or an electrode. Other end effectors may include a pair or plurality of working members such as forceps, graspers, scissors, biopsy device, or clip appliers, for example. Examples of electrically activated end effectors include electrosurgical electrodes, transducers, sensors, and the like. Also or alternatively, the flexible body <NUM> can define one or more lumens through which interventional tools can be deployed and used at a target surgical location. Such interventional tools may include one or more cameras, biopsy devices, laser ablation fibers, medicinal delivery systems, or position and orientation sensors.

The instrument handpiece <NUM> includes a manual actuator <NUM> such as a lever or dial movable by a user (e.g., by the user's hand or thumb) to manually control the movement of the opposing drive components <NUM>, <NUM>. The instrument handpiece <NUM> includes a drive input <NUM> movable by a drive system <NUM> to control the movement of the drive component <NUM> and a drive input <NUM> movable by a drive system <NUM> to control the movement of the drive component <NUM>. As will be described in greater detail, below, the drive systems <NUM>, <NUM> may be motorized components of a robotic interventional system. Optionally, a sterile adaptor disk <NUM> attached to a sterile drape may be coupled to a drive input (e.g., drive input <NUM>). Similarly, an optional sterile adaptor disk <NUM> attached to a sterile drape may be coupled to a drive input (e.g., drive input <NUM>). The sterile adaptor disk <NUM> imparts the motion from the drive system <NUM> to the drive input <NUM> while maintaining a sterile barrier between the sterile instrument components and non-sterile robotic components. In alternative embodiments, the optional adaptor disks may be non-sterile, serving to accommodate small mis-alignments between individual motor outputs and instrument inputs. As used herein, removable engagement of drive inputs with drive mechanisms includes direct engagement and indirect engagement via adaptor disks. The drive input <NUM> may be coupled to the manual actuator <NUM> by a drive component <NUM>. Drive component <NUM> may a part of the drive component <NUM> (i.e., the length of the drive component <NUM> between the drive input and the manual actuator). Alternatively, drive components <NUM> and <NUM> may be separately connected to the manual actuator <NUM>. The drive input <NUM> may be coupled to the manual actuator <NUM> by a drive component <NUM>. Drive component <NUM> may a part of the drive component <NUM> (i.e., the length of the drive component <NUM> between the drive input and the manual actuator). Alternatively, drive components <NUM> and <NUM> may be separately connected to the manual actuator <NUM>. The instrument handpiece <NUM> further includes a tensioning system <NUM> which prevents the opposing drive components <NUM>, <NUM> from becoming slack and decoupling from the drive inputs or manual actuator. The drive input <NUM> may be coupled to the tensioning system <NUM> by a drive component <NUM>. Drive component <NUM> may a part of the drive component <NUM> (i.e., the length of the drive component <NUM> between the drive input and the tensioning system). Alternatively, drive components <NUM> and <NUM> may be separately connected to the drive input <NUM>. The drive input <NUM> may be coupled to the tensioning system <NUM> by a drive component <NUM>. Drive component <NUM> may be a part of the drive component <NUM> (i.e., the length of the drive component <NUM> between the drive input and the tensioning system). Alternatively, drive components <NUM> and <NUM> may be separately connected to the drive input <NUM>.

When the hybrid instrument system <NUM> is used in a robotically controlled mode, the instrument handpiece <NUM> may be a component of a hybrid manual and robotic interventional system. <FIG> illustrates such a system <NUM>. The system <NUM> may be used for, for example, in surgical, diagnostic, therapeutic, or biopsy procedures. As shown in <FIG>, the robotic system <NUM> generally includes an interventional manipulator assembly <NUM> (e.g., a robotic arm linkage) for operating a hybrid interventional instrument <NUM> (e.g., the hybrid instrument system <NUM>) in performing various procedures on the patient P. As depicted, the interventional instrument <NUM> is decoupled from the interventional manipulator <NUM> for use in manual mode by a surgeon S1. In robotic control mode, the interventional instrument would be coupled to the interventional manipulator <NUM>. (See, e.g. <FIG>) The manipulator assembly <NUM> is mounted to or near an operating table O. An operator input system <NUM> allows a surgeon S2 to view the surgical site and to control the operation of the interventional manipulator assembly <NUM>. In some circumstances, the same person may operate the manual instrument and operate the operator input.

The operator input system <NUM> may be located at a surgeon's console which is usually located in the same room as operating table O. However, it should be understood that the surgeon S2 can be located in a different room or a completely different building from the patient P. Operator input system <NUM> generally includes one or more control device(s) for controlling the manipulator assembly <NUM>. The control device(s) may include any number of a variety of input devices, such as hand grips, joysticks, trackballs, data gloves, trigger-guns, hand-operated controllers, voice recognition devices, touch screens, body motion or presence sensors, or the like. In some embodiments, the control device(s) will be provided with the same degrees of freedom as the associated interventional instruments <NUM> to provide the surgeon with telepresence, or the perception that the control device(s) are integral with the instruments <NUM> so that the surgeon has a strong sense of directly controlling instruments <NUM>. In other embodiments, the control device(s) may have more or fewer degrees of freedom than the associated interventional instruments <NUM> and still provide the surgeon with telepresence. In some embodiments, the control device(s) are manual input devices which move with six degrees of freedom, and which may also include an actuatable handle for actuating instruments (for example, for closing grasping jaws, applying an electrical potential to an electrode, delivering a medicinal treatment, or the like).

In alternative embodiments, the robotic system may include more than one manipulator assembly and/or more than one operator input system. The exact number of manipulator assemblies will depend on the surgical procedure and the space constraints within the operating room, among other factors. The operator input systems may be collocated, or they may be positioned in separate locations. Multiple operator input systems allow more than one operator to control one or more manipulator assemblies in various combinations.

An optional sensor system <NUM> includes one or more sub-systems for receiving information about the instrument <NUM>. Such sub-systems may include a position sensor system (e.g., an electromagnetic (EM) sensor system); a shape sensor system for determining the position, orientation, speed, pose, and/or shape of the catheter tip at (e.g., distal end <NUM> in <FIG>) and/or of one or more segments along a flexible body of instrument <NUM>; and/or a visualization system for capturing images from the distal end of the catheter system. The position sensor system, the shape sensor system, and/or the visualization system may interface with a tracking system of the robotic interventional system. The tracking system may be implemented as hardware, firmware, software or a combination thereof which interact with or are otherwise executed by one or more computer processors, which may include the processors of a control system <NUM>, described in greater detail below.

The optional position sensor system may be an EM sensor system that includes one or more conductive coils that may be subjected to an externally generated electromagnetic field. Each coil of the EM sensor system then produces an induced electrical signal having characteristics that depend on the position and orientation of the coil relative to the externally generated electromagnetic field. In one embodiment, the EM sensor system may be configured and positioned to measure six degrees of freedom, e.g., three position coordinates X, Y, Z and three orientation angles indicating pitch, yaw, and roll of a base point. Further description of an EM sensor system is provided in <CIT>, disclosing "Six-Degree of Freedom Tracking System Having a Passive Transponder on the Object Being Tracked".

The optional shape sensor system includes an optical fiber aligned with the flexible body of the instrument (e.g., provided within an interior channel (not shown) or mounted externally). In one embodiment, the optical fiber has a diameter of approximately <NUM>. In other embodiments, the dimensions may be larger or smaller.

The optical fiber of the shape sensor system forms a fiber optic bend sensor for determining the shape of the catheter system of instrument <NUM>. In one alternative, optical fibers including Fiber Bragg Gratings (FBGs) are used to provide strain measurements in structures in one or more dimensions. Various systems and methods for monitoring the shape and relative position of an optical fiber in three dimensions are described in <CIT>, disclosing "Fiber optic position and shape sensing device and method relating thereto;" <CIT>, disclosing "Fiber-optic shape and relative position sensing;" and <CIT>, disclosing "Optical Fibre Bend Sensor". In other alternatives, sensors employing other strain sensing techniques such as Rayleigh scattering, Raman scattering, Brillouin scattering, and Fluorescence scattering may be suitable. In other alternative embodiments, the shape of the catheter may be determined using other techniques.

Optionally, the optical fiber may include multiple cores within a single cladding. Each core may be single-mode with sufficient distance and cladding separating the cores such that the light in each core does not interact significantly with the light carried in other cores. In other embodiments, the number of cores may vary or each core may be contained in a separate optical fiber. In some embodiments, an array of FBG's is provided within each core. Each FBG comprises a series of modulations of the core's refractive index so as to generate a spatial periodicity in the refraction index. The spacing may be chosen so that the partial reflections from each index change add coherently for a narrow band of wavelengths, and therefore reflect only this narrow band of wavelengths while passing through a much broader band. During fabrication of the FBG's, the modulations are spaced by a known distance, thereby causing reflection of a known band of wavelengths. However, when a strain is induced on the fiber core, the spacing of the modulations will change, depending on the amount of strain in the core. Alternatively, backscatter or other optical phenomena that vary with bending of the optical fiber can be used to determine strain within each core. Thus, to measure strain, light is sent down the fiber, and characteristics of the returning light are measured. For example, FBG's produce a reflected wavelength that is a function of the strain on the fiber and its temperature. This FBG technology is commercially available from a variety of sources, such as Smart Fibres Ltd. of Bracknell, England. Use of FBG technology in position sensors for robotic surgery is described in <CIT>, disclosing "Robotic Surgery System Including Position Sensors Using Fiber Bragg Gratings".

When applied to a multicore fiber, bending of the optical fiber induces strain on the cores that can be measured by monitoring the wavelength shifts in each core. By having two or more cores disposed off-axis in the fiber, bending of the fiber induces different strains on each of the cores. These strains are a function of the local degree of bending of the fiber. For example, regions of the cores containing FBG's, if located at points where the fiber is bent, can thereby be used to determine the amount of bending at those points. These data, combined with the known spacings of the FBG regions, can be used to reconstruct the shape of the fiber. Such a system has been described by Luna Innovations. of Blacksburg, Va. The sensing may be limited only to the degrees of freedom that are actuated by the robotic system, or may be applied to both passive (e.g., unactuated bending of the rigid members between joints) and active (e.g., actuated movement of the instrument) degrees of freedom.

The visualization sub-system of sensor system <NUM> may include an image capture probe extending through the instrument catheter (not shown) for providing concurrent (real-time) image of the surgical site to surgeon. The image capture probe may include a tip portion with a stereoscopic or monoscopic camera disposed near, for example, the distal end <NUM> of the flexible body <NUM> of <FIG> for capturing images (including video images) that are transmitted to and processed by the robotic interventional system for display. The image capture probe may include a cable coupled to the camera for transmitting the captured image data. Alternatively, the image capture instrument may be a fiber-optic bundle, such as a fiberscope, that couples to the imaging system. The image capture instrument may be single or multi-spectral, for example capturing image data in the visible spectrum, or capturing image data in the visible and infrared or ultraviolet spectrums.

The captured image may be, for example, a two- or three-dimensional image captured by an endoscopic probe positioned within the surgical site. In this embodiment, the visualization sub-system includes endoscopic components that may be integrally or removably coupled to the interventional instrument <NUM>. In alternative embodiments, however, a separate endoscope attached to a separate manipulator assembly may be used to image the surgical site. Alternatively, a separate endoscope assembly may be directly operated by a user, without robotic control. The endoscope assembly may include active steering (e.g., via teleoperated steering wires) or passive steering (e.g., via guide wires or direct user guidance). The visualization system may be implemented as hardware, firmware, software, or a combination thereof, which interacts with or is otherwise executed by one or more computer processors, which may include the processor(s) of a control system <NUM>.

A display system <NUM> may display an image of the surgical site and interventional instruments generated by sub-systems of the sensor system <NUM>. The display <NUM> and the operator input system <NUM> may be oriented such that the relative positions of the imaging device in the scope assembly and the interventional instruments are similar to the relative positions of the surgeon's eyes and hand(s) so the operator can manipulate the interventional instrument <NUM> and the operator input system <NUM> as if viewing the workspace in substantially true presence. True presence means that the displayed tissue image appears to an operator as if the operator was physically present at the imager location and directly viewing the tissue from the imager's perspective.

Alternatively or additionally, display system <NUM> may present images of the surgical site recorded and/or modeled preoperatively using imaging technology such as computerized tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, or the like. The presented preoperative images may include two-dimensional, three-dimensional, or four-dimensional (including e.g., time based or velocity based information) images and models.

In some embodiments, the display system <NUM> may display a virtual visualization image in which the actual location of the interventional instrument is registered (e.g., dynamically referenced) with preoperative or concurrent images to present the surgeon with a virtual image of the internal surgical site at the location of the tip of the surgical instrument.

In other embodiments, the display system <NUM> may display a virtual visualization image in which the actual location of the interventional instrument is registered with prior images (including preoperatively recorded images) or concurrent images to present the surgeon with a virtual image of an interventional instrument at the surgical site. An image of a portion of the interventional instrument may be superimposed on the virtual image to assist the surgeon controlling the interventional instrument.

As shown in <FIG>, a control system <NUM> includes at least one processor (not shown), and typically a plurality of processors, for effecting control between the surgical manipulator assembly <NUM>, the operator input system <NUM>, the sensor system <NUM>, and the display system <NUM>. The control system <NUM> also includes programmed instructions (e.g., a computer-readable medium storing the instructions) to implement some or all of the methods described herein. While control system <NUM> is shown as a single block in the simplified schematic of <FIG>, the system may comprise a number of data processing circuits (e.g., on the surgical manipulator assembly <NUM> and/or on the operator input system <NUM>), with at least a portion of the processing optionally being performed adjacent the surgical manipulator assembly, a portion being performed adjacent the operator input system, and the like. Any of a wide variety of centralized or distributed data processing architectures may be employed. Similarly, the programmed instructions may be implemented as a number of separate programs or subroutines, or they may be integrated into a number of other aspects of the robotic systems described herein. In one embodiment, control system <NUM> supports wireless communication protocols such as Bluetooth, IrDA, HomeRF, IEEE <NUM>, DECT, and Wireless Telemetry.

In some embodiments, control system <NUM> may include one or more servo controllers to provide force and torque feedback from the interventional instruments <NUM> to one or more corresponding servomotors for the operator input system <NUM>. The servo controller(s) may also transmit signals instructing manipulator assembly <NUM> to move instruments which extend into an internal surgical site within the patient body via openings in the body. Any suitable conventional or specialized servo controller may be used. A servo controller may be separate from, or integrated with, manipulator assembly <NUM>. In some embodiments, the servo controller and manipulator assembly are provided as part of a robotic arm cart positioned adjacent to the patient's body.

The control system <NUM> may further include a virtual visualization system to provide navigation assistance to instrument <NUM>. Virtual navigation using the virtual visualization system is based upon reference to an acquired dataset associated with the three dimensional structure of the anatomical passageways. More specifically, the virtual visualization system processes images of the surgical site recorded and/or modeled using imaging technology such as computerized tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, or the like. Software is used to convert the recorded images into a two dimensional or three dimensional model of a partial or an entire anatomical organ or anatomical region. The model describes the various locations and shapes of the passageways and their connectivity. The images used to generate the model may be recorded preoperatively or intra-operatively during a clinical procedure. In an alternative embodiment, a virtual visualization system may use standard models (i.e., not patient specific) or hybrids of a standard model and patient specific data. The model and any virtual images generated by the model may represent the static posture of a deformable anatomic region during one or more phases of motion (e.g., during an inspiration/ expiration cycle of a lung).

During a virtual navigation procedure, the sensor systems may be used to compute an approximate location of the instrument with respect to the patient anatomy. The location can be used to produce both macro-level tracking images of the patient anatomy and virtual internal images of the patient anatomy. Various systems for using fiber optic sensors to register and display an interventional implement together with preoperatively recorded surgical images, such as those from a virtual visualization system, are known. For example <CIT>, disclosing, "Medical System Providing Dynamic Registration of a Model of an Anatomical Structure for Image-Guided Surgery" , discloses one such system.

The control system <NUM> may further include a navigation system for processing information from the virtual visualization system and the sensor tracking system to generate a virtual image display on the display system <NUM>. The system <NUM> may further include optional operation and support systems (not shown) such as illumination systems, steering control systems, irrigation systems, and/or suction systems.

In robotic control mode, the manipulator assembly <NUM> supports the hybrid interventional instrument <NUM> and may comprise a kinematic structure of one or more non-servo controlled links (e.g., one or more links that may be manually positioned and locked in place, generally referred to as a set-up structure) and a robotic manipulator. The robotic manipulator assembly <NUM> is driven by a plurality of actuators (e.g., motors). These motors actively move the robotic manipulators in response to commands from the control system <NUM>. The motors include drive systems (e.g., drive systems <NUM>, <NUM>) which when coupled to the interventional instrument may advance the interventional instrument into a naturally or surgically created anatomical orifice and/or may move the distal end of the interventional instrument in multiple degrees of freedom, which may include three degrees of linear motion (e.g., linear motion along the X, Y, Z Cartesian axes) and three degrees of rotational motion (e.g., rotation about the X, Y, Z Cartesian axes). Additionally, the motors can be used to actuate an articulable end effector of the instrument for grasping tissue in the jaws of a biopsy device or the like.

In various embodiments, a hybrid interventional instrument system <NUM>, <NUM> may be a flexible bronchial instrument, such as a bronchoscope or bronchial catheter for use in examination, diagnosis, biopsy, or treatment of a lung. A hybrid manual/ robotic instrument may be useful for bronchial procedures because in the manual mode, decoupled from robotic control, a bronchoscopist is able to manually navigate the instrument through the patient's mouth, nose, or a tracheal incision and past delicate anatomical structures such as the vocal cords. When navigating these portions of the patient anatomy (especially at the beginning and ending of a procedure), the bronchoscopist may be able to physically sense the position and orientation of the distal end of the instrument based upon clearly discernible visual and tactile cues. Robotic control and navigation may be a safer or more effective form of control after the distal end of the instrument is positioned in the lung where location and orientation determination based on sensors, camera images, pre-operative modeling, and other indirect indicia becomes more complex. Thus, a single instrument that may be selectively operated by either robotic or by manual control may be an efficient solution.

<FIG> illustrate a robotic interventional system <NUM> for use in performing a procedure on a patient P1. The robotic interventional system <NUM> may include any or all of the components of the system <NUM> but for clarity, only select components are illustrated in <FIG>. The system <NUM> includes a manipulator assembly <NUM> (e.g., robotic manipulator assembly <NUM>) controlled by a remote control device <NUM> (e.g., operator input system <NUM>). The manipulator assembly <NUM> includes an insertion drive <NUM> and a pitch and/or yaw drive <NUM>. The drives <NUM>, <NUM> may be, for example, servo motor drive mechanisms. An interventional instrument <NUM> includes a handpiece <NUM> and a flexible body <NUM> sized for insertion into an anatomic passageway of patient P1. An optical fiber <NUM> passes through the handpiece <NUM> and the flexible body <NUM> for measuring the shape of the flexible body or for recording images from the distal end of the flexible body. A latching mechanism <NUM> mechanically couples the handpiece <NUM> to the manipulator assembly <NUM>. The handpiece <NUM> includes a manual actuator <NUM>.

In the configuration of <FIG>, the interventional instrument <NUM> is connected to the manipulator assembly <NUM> for use in a robotic control mode. The insertion drive <NUM> controls motion of the flexible body <NUM> in and out of the patient P1 in response to a user input at the remote control device <NUM>. The drive <NUM> controls the motion of a distal end of the flexible body <NUM> in at least one degree of freedom (e.g., pitch, yaw, or roll) in response to user inputs at the remote control device <NUM>. Optionally, the drive <NUM> may control motion of the distal end of the flexible body <NUM> in multiple degrees of freedom. Thus, in this robotic control configuration, the insertion and the distal end motion of the interventional instrument is controlled by the remote user via the robotic manipulator assembly.

In the configuration of <FIG>, the interventional instrument <NUM> has been disconnected from the manipulator assembly <NUM> by disengaging the latching mechanism <NUM> and decoupling the drives of the manipulator assembly <NUM> from the drive inputs (not shown) of the handpiece. With the instrument <NUM> disconnected from the assembly <NUM>, the instrument <NUM> can be held directly by a user, and the user manually advances or withdraws the flexible body <NUM> to control the insertion of the instrument. The user may control roll of the flexible body <NUM> by rotating the handpiece (e.g., by twisting the user's wrist). To control the motion of the distal end of the flexible body <NUM> in one or more degrees of freedom (e.g., pitch or yaw), the user directly toggles the manual actuator <NUM>. Optionally, the actuator <NUM> may control motion of the distal end of the flexible body <NUM> in multiple degrees of freedom.

<FIG> illustrates another robotic interventional system <NUM> for use in performing a procedure on a patient P1. The robotic interventional system <NUM> may include any or all of the components of the system <NUM> but for clarity, only select components are illustrated in <FIG>. System <NUM> includes a manipulator assembly <NUM> controlled by a remote control device <NUM>. The manipulator assembly <NUM> includes an insertion drive <NUM>. An interventional instrument <NUM> includes a handpiece <NUM> and a flexible body <NUM> sized for insertion into an anatomic passageway of patient P1. An optical fiber <NUM> passes through the handpiece <NUM> and the flexible body <NUM> for measuring the shape of the flexible body or for recording images from the distal end of the flexible body. The handpiece <NUM> includes a manual actuator <NUM>. In this embodiment, a drive mechanism <NUM> includes servo motors for controlling the motion of the distal end of the flexible body <NUM> in at least one degree of freedom. The drive mechanism <NUM> and interventional instrument <NUM> may be attached to the manipulator assembly <NUM> such that the insertion and distal end motion of the instrument is robotically controlled as in <FIG>. In this embodiment, however, the drive mechanism <NUM> and the instrument <NUM> may be detached from the manipulator. When detached, the distal end motion of the instrument may continue to be controlled by the mechanism <NUM>. The drive mechanism <NUM> may be coupled to a power source by a power input <NUM>. Other cables or wireless connections (not shown) may provide control instructions to the drive mechanism <NUM> from a remote controller. Alternatively, the drive mechanism <NUM> may include batteries or other self-contained portable power supplies to allow untethered use of the instrument <NUM>. In various alternatives, the drive mechanism <NUM> may be deactived while still directly attached to the instrument <NUM> to allow a user to directly toggle the actuator <NUM> for manually controlling the motion of the distal end of the instrument in at least one degree of freedom.

<FIG> illustrates the robotic interventional system <NUM> further including an optional insertion drive mechanism <NUM> coupled to the flexible body <NUM>. Like the drive mechanism <NUM>, the insertion-drive mechanism <NUM>, may be portable and may be separately powered and controlled. When the instrument <NUM> is detached from the manipulator <NUM>, the advancement and withdrawal of the flexible body <NUM> from the patient P1 may be controlled by the portable insertion drive mechanism <NUM>.

<FIG> & <FIG> illustrate an interventional instrument <NUM> according to another embodiment of the present disclosure. The instrument <NUM> includes an elongated flexible body <NUM> coupled to a handpiece <NUM>. The handpiece <NUM> includes a grip portion <NUM>, a tool port <NUM>, and interface housing <NUM>. The handpiece also includes a plurality of drive inputs <NUM> for interfacing with the drive system of a robotic manipulator. The handpiece <NUM> further includes a manual actuator <NUM> pivotable about a pivot <NUM> for manually controlling the motion of a distal end of the elongated flexible body <NUM> in at least one degree of freedom (e.g., pitch, yaw, and/or roll). In this and other embodiments, the at least one degree of freedom may be referred to as a pitch motion, but it is understood that one or more manual actuators of the handpiece may control motion of the distal end of the flexible body <NUM> in one or more other degrees of freedom such as yaw and/or roll.

The tool port <NUM> is sized and shaped to receive auxiliary tools for insertion through a channel in the flexible body <NUM>. Auxiliary tools may include, for example, cameras, biopsy devices, laser ablation fibers, position and orientation sensors or other surgical, diagnostic, or therapeutic tools. In this embodiment, the grip portion <NUM> has a tapered shaft sized for comfortable grip by a human hand. In various alternative embodiments, the grip portion may have ergonomic features such as indentions sized to cradle user fingers or non-slip surfaces.

In this embodiment, the handpiece <NUM> includes engagement features <NUM>, such as elongated protrusions, that cause the handpiece <NUM> to couple to the robotic manipulator in a direction D1 that is approximately transverse to the insertion direction D2 of the elongated flexible body <NUM>. The transverse coupling direction reduces the risk that coupling the handpiece to the manipulator will move the distal end of the flexible body in the insertion direction D2, thus reducing the risk of injury to the patient or disrupting the navigation that would otherwise result from inadvertent advancement or retraction of the flexible body within the tiny and delicate anatomical passageways of the patient. Alternatively, engagement features may be provided that would cause the handpiece <NUM> to couple to the robotic manipulator in a direction D3 that is also approximately transverse to the insertion direction D2 of the elongated flexible body <NUM>. The transverse coupling direction would also reduce the risk of moving the handpiece in direction D2 when coupling the handpiece to the robotic manipulator.

In a manual mode, unconnected to a robotic manipulator, a user grasps the grip portion <NUM> of the instrument <NUM> and holds the handpiece <NUM> such that the user's thumb rests near or against the manual actuator <NUM>. The user manually controls insertion motion (i.e., in the direction D2) by advancing or withdrawing the handpiece <NUM> relative to the patient's anatomy. The user manually controls the pitch motion M1 by pivoting the manual actuator <NUM> with the motion M2. For example, pivoting the manual actuator toward the distal end of the instrument pitches the distal end of the flexible body up, and pivoting the manual actuator toward the proximal end of the instrument pitches the distal end of the flexible body down. In alternative embodiments, the motion of the manual actuator may cause the pitch motions in the opposite directions. In still other alternatives, the motion of the manual actuator may cause motion of the distal end of the flexible body in other degrees of freedom such as yaw or roll.

In robotic mode, the instrument <NUM> is directly connected to the robotic manipulator. The drive inputs <NUM> provide mechanical coupling of the end effector and flexible body steering mechanism with the drive motors mounted to the manipulator. For example, a pair of drive inputs may control the pitch motion M1 of the distal end of the flexible body, with one adaptor of the pair controlling motion in the upward direction and the other of the pair controlling motion in the opposite downward direction. Other pairs of drive inputs may provide opposing motion in other degrees of freedom for the flexible body and/or the end effector. Instrument interfacing with robotic manipulators is described, for example in <CIT>, disclosing "Surgical Robotic Tools, Data Architecture, And Use" and <CIT> disclosing "Mechanical Actuator Interface System For Robotic Surgical Tools".

<FIG> illustrates an interventional instrument <NUM> according to another embodiment of the present disclosure. The instrument <NUM> includes an elongated flexible body <NUM> coupled to a handpiece <NUM>. The handpiece <NUM> includes a grip portion <NUM>, a tool port <NUM>, and interface housing <NUM>. The handpiece also includes a plurality of drive inputs <NUM> for interfacing with the drive system of a robotic manipulator.

The handpiece <NUM> further includes a manual actuator <NUM> pivotable about a pivot <NUM> for manually controlling the motion of a distal end of the elongated flexible body <NUM>. In this embodiment, the manual actuator <NUM> includes two levers (not clearly shown in <FIG>, but see similar configuration in <FIG>). Each of the levers controls opposing motions of a single degree of freedom, e. g, pitch motion. Alternatively, one pivoting lever can control opposing yaw motions and the other pivoting lever can control opposing pitch motions of the distal end of the flexible body.

In this embodiment, engagement features, such as elongated protrusions <NUM>, enable the handpiece <NUM> to couple to the robotic manipulator in the direction D1 that is approximately transverse to the insertion direction D2 of the elongated flexible body <NUM>. The transverse coupling direction reduces the risk that coupling the handpiece manipulator will move the distal end of the flexible body in the insertion direction D2, thus reducing the risk of injury to the patient or disrupting the navigation that would otherwise result from inadvertent advancement or retraction of the flexible body within the tiny and delicate anatomical passageways of the patient.

The handpiece <NUM> further includes an unlatching mechanism for removing the instrument <NUM> from the robotic manipulator. In this embodiment, the unlatching mechanism includes a pair of tabs <NUM> connected by a biasing member (e.g. an extension spring) and connected to a pair of links <NUM>. When the handpiece <NUM> is coupled to the robotic manipulator, squeezing the tabs <NUM> together moves the links toward the robotic manipulator, disengaging the handpiece inputs <NUM> from the robotic manipulator. Then the handpiece <NUM> may be disengaged from the robotic manipulator, and after disengagement, the instrument <NUM> may be operated in manual mode. The actuation of the instrument <NUM> in manual and robotic control modes is similar to the actuation described above for instrument <NUM> except that the dual lever manual actuator <NUM> permits a user, in manual mode, to control opposing motions of a single degree of freedom of the distal end of the flexible body (e.g. pitch up and pitch down). Alternatively, a dual lever manual actuator may be configured so that each of the two levers controls a different degree of freedom in two directions (e.g., the right lever controls pitch up and down and the left lever controls yaw left and right).

As shown in <FIG>, a manual actuator <NUM> is manipulated by a user to control motion of the distal end of the flexible body when the handpiece <NUM> is used in manual mode. <FIG>, <FIG>, and <FIG> illustrate different embodiments for the manual actuator. In other respects, <FIG>, 10a, and <FIG> are similar to <FIG>.

<FIG> schematically illustrates an interventional instrument <NUM> and <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> illustrate an implementation of the interventional instrument <NUM> schematically illustrated in <FIG>. The system <NUM> includes a catheter system <NUM> coupled to an instrument handpiece <NUM> which includes a grip portion <NUM>. The catheter system <NUM> includes an elongated flexible body <NUM>. The flexible body <NUM> houses opposing drive components 608a, 608b for moving the distal end of the flexible body in opposite directions in one degree of freedom (e. g, pitch degree of freedom motion). The flexible body <NUM> also houses opposing drive components 610a, 610b for moving the distal end of the flexible body in opposite directions in another degree of freedom (e.g. yaw degree of freedom). In this embodiment the drive components are tendons, such as pull wires, that extend from the instrument handpiece <NUM> to the distal end of the flexible body.

The instrument handpiece <NUM> includes frame <NUM> and pulleys 612a, 612b, 613a, 614a, 614b, 615a, 615b rotatably coupled to the frame. Alignment mechanisms 617a, 617b are also coupled to the frame <NUM>. The handpiece <NUM> further includes a manual actuator <NUM> that includes a lever 616a mechanically linked to a capstan mechanism <NUM>. The manual actuator <NUM> also includes a lever 616b mechanically linked to a capstan mechanism <NUM>. A biasing member <NUM>, such as a spring, extends between the capstan mechanisms <NUM>, <NUM>.

The instrument handpiece <NUM> further includes a drive input 622a movable by a motorized drive system <NUM> to control the movement of the drive component 608a in one direction of a degree of freedom (e.g., pitch down). The handpiece <NUM> also includes a drive input 626a movable by a motorized drive system <NUM> to control the movement of drive component 608b in an opposite direction of the same degree of freedom (e.g., pitch up). The drive systems <NUM>, <NUM> are components of the robotic manipulator that includes the drive motors. The drive input 622a includes a disk shaped engagement portion 622b and an input shaft portion 622c. A helical groove drive capstan 622d is supported by the shaft portion 622c. The engagement portion 622b may be removably coupled to the drive system <NUM>. The input shaft portion 622c is integrally formed or fixedly coupled to the engagement portion 622b. The drive input 626a includes an engagement portion 622b and an input shaft portion 626c. A helical groove drive capstan 626d is supported by the shaft portion 626c. The engagement portion 626b may be removably coupled to the drive system <NUM>. The input shaft portion 626c is integrally formed or fixedly coupled to the engagement portion 626b. The instrument handpiece <NUM> further includes a tensioning system <NUM> (e.g., a pitch tensioning system) which prevents the opposing drive components 608a, 608b from becoming slack and decoupling from or entangling about the drive input capstans, pulleys, or lever capstan mechanisms.

The instrument handpiece <NUM> further includes a drive input 636a movable by a motorized drive system <NUM> to control the movement of the drive component 610a in one direction of a degree of freedom (e.g., yaw right). A helical groove drive capstan 636b is connected to the drive input 636a. The handpiece <NUM> also includes a drive input 638a movable by a motorized drive system <NUM> to control the movement of drive component 610b in an opposite direction of the same degree of freedom (e.g., yaw left). A helical groove drive capstan 638b is connected to the drive input 638a. The drive systems <NUM>, <NUM> are components of the robotic manipulator that includes the drive motors. The instrument handpiece <NUM> further includes a tensioning system <NUM> (e.g., a yaw tensioning system) which prevents the opposing drive components 610a, 610b from becoming slack and decoupling from the drive inputs capstans or the pulleys. The operation of a gear-based tensioning system such as systems <NUM>, <NUM> will be described in greater detail for <FIG>.

In this embodiment, each of the drive components 608a, 608b, 610a, and 610b includes a pull wire portion extending through distal end of the instrument handpiece <NUM> and into the flexible body <NUM>. The wire portion is coupled, for example by crimping, to a cable portion that extends between the drive input and the wire portion. The cable portion may resist kinks, allowing the drive component to traverse the tight turns in the pulley system of the handpiece. In alternative embodiments, the drive components may be formed from a continuous length of tendon.

A cable portion of the pitch down drive component 608a is wound around the drive capstan 622d and over a portion of the alignment mechanism 617a to align the drive component with the pulley 612a. In this embodiment, the drive component 608a is bent to an angle between approximately <NUM>° and <NUM>° around the pulley 612a. In alternative embodiments, the angles of the cables formed by the pulleys may be larger or smaller. The drive component 608a extends around and is fixed to the lever capstan mechanism <NUM>. Another length of cable of the drive component is fixed to the lever capstan mechanism <NUM> and extends over the pulley 612b and is crimped to the pull wire portion of the drive component 608a. In alternative embodiments, the cable portion may be continuous without separate portions fixed to the capstan <NUM>.

A cable portion of the pitch up drive component 608b is wound around the drive capstan 626b and over a portion of the alignment mechanism 617b to align the drive component with the pulley 613a. In this embodiment, the drive component 608b is bent to an angle of approximately <NUM>° around the pulley 613a. The drive component extends around and is fixed to the lever capstan mechanism <NUM>. Another length of cable of the drive component is fixed to the lever capstan mechanism <NUM> and is crimped to the pull wire portion of the drive component 608b. In alternative embodiments, the cable portion may be continuous without separate portions fixed to the capstan <NUM>.

A cable portion of the yaw right drive component 610a is wound around the drive capstan 636b, extends over a pulley 607a and at least partially around the pulley 614b, and is crimped to the pull wire portion of the drive component 610a. A cable portion of the yaw left drive component 610b is wound around the drive capstan 638b, at least partially around the pulley 615a, at least partially around the pulley 607b, and at least partially around the pulley 615b. The cable portion is then crimped to the pull wire portion of the drive component 610b. The various capstans, alignment mechanisms, and pulleys serve to keep the cables untangled, aligned, and free of kinks as the cables traverse the handpiece between the drive inputs and the catheter system. Because the axes of the drive input shafts (e.g., axis A1 of shaft 622c) are generally parallel with the axis A2 of the grip portion <NUM>, the drive components may bend at least once at an approximate right angle along their paths within the handpiece <NUM>.

In use in manual mode, a clinician grips the grip portion <NUM> of the handpiece <NUM> with a thumb positioned near the levers 616a and 616b. In manual mode, the clinician can control a range of motion (e.g., pitch, roll, and insertion) of the distal end <NUM> of the catheter <NUM>. To move the distal end <NUM> of the catheter to pitch downward (D1 down), the clinician pushes the lever 616a (e.g., clockwise in <FIG>) which transmits a rotational motion to the lever capstan <NUM>. Rotation of the lever capstan <NUM> retracts the drive component 608a, causing the distal end <NUM> of the catheter <NUM> to pitch downward. The lever 616a may include differently angled surfaces or other tactile cues to allow the clinician to easily recognize the direction of motion associated with each lever. To move the distal end <NUM> of the catheter to pitch upward (D1 up), the clinician pushes the lever 616b (e.g., clockwise in <FIG>) which transmits a rotational motion to the lever capstan <NUM>. Rotation of the lever capstan <NUM> retracts the drive component 608b, causing the distal end <NUM> of the catheter <NUM> to pitch upward. The roll of the distal end <NUM> of the catheter <NUM> about axis A2 is controlled by bending of the clinician's wrist. The insertion of the distal end <NUM> of the catheter <NUM> is controlled by clinician advancing or retracting the handpiece <NUM> relative to the patient.

To move the instrument system <NUM> into robotic control mode, the drive inputs 622a, 626a, 636a, 638a are coupled to motorized drive systems <NUM>, <NUM>, <NUM>, <NUM>, respectively, of a robotic manipulator. As previously described, coupling of the drive inputs and drive systems may occur in a direction transverse to the insertion axis A2 to reduce the risk of advancing or retracting the distal end <NUM> of the catheter <NUM>.

In robotic control mode, the clinician can control a range of motion (e.g., pitch, yaw, roll, and insertion) of the distal end <NUM> of the catheter <NUM>. Movement of the drive input 622a turns the capstan 622d and retracts the drive component 608a, causing the distal end <NUM> of the catheter <NUM> to pitch downward. Movement of the drive input 626a turns the capstan 626b and retracts the drive component 608b, causing the distal end <NUM> of the catheter <NUM> to pitch upward. Movement of the drive input 636a turns the capstan 636b and retracts the drive component 610a, causing the distal end <NUM> of the catheter <NUM> to yaw rightward. Movement of the drive input 638a turns the capstan 638b and retracts the drive component 610b, causing the distal end <NUM> of the catheter <NUM> to yaw leftward. The roll and insertion of the distal end <NUM> of the catheter <NUM> is controlled by movement of the robotic manipulator.

To remove the handpiece <NUM> from the robotic manipulator and transition the handpiece into manual mode, the tabs 630a of the unlatching mechanism <NUM> are squeezed, compressing spring <NUM> (See. Squeezing the tabs together moves the links 630b toward the robotic manipulator, optionally moving a plate carrying adaptors such as <NUM> and <NUM> of <FIG>, disengaging the drive inputs from the drive systems and allowing disengagement of hand piece <NUM> from the robotic manipulator in a direction transverse to axis A2 of body <NUM>.

As shown in <FIG>, the handpiece <NUM> also includes a tool port <NUM> sized and shaped to receive auxiliary tools for insertion through a channel in the flexible body <NUM>. The location of the tool port may be determined to accommodate the drive components and the clinician's grip. Referring to <FIG>, the handpiece <NUM> also includes a collar <NUM> coupling the flexible body <NUM> to the grip portion <NUM>. At least a portion of the drive components 608a, 608b, 610a, 610b may be formed of Bowden cable <NUM> having an elongated inner component (e.g., a wire or cable) movable with respect to and an elongated outer coiled sheath. The inner component may be crimped to the cable portions of the drive components as previously explained. A stud component <NUM> is attached to the outer coiled sheath (e.g., by epoxy) and is held fixed relative to the grip portion <NUM> by a clamping plate <NUM> held in place by fastener <NUM>. As the drive components are manipulated in either manual or robotic control, the Bowden cable portions of the drive components may flex and bulge out through slots <NUM> (<FIG>) in the handpiece <NUM>. This is because with the outer coiled sheath constrained at the proximal end clamping plate is constrained from axial movement along the axis A2.

<FIG> schematically illustrates an interventional instrument <NUM>. In this embodiment the interventional instrument has a manual actuator with a single control lever and a tensioning system coupled between opposing drive components. The system <NUM> includes a catheter system <NUM> coupled to an instrument handpiece <NUM>. The catheter system <NUM> includes an elongated flexible body <NUM>. The flexible body <NUM> houses opposing drive components 658a, 658b for moving the distal end of the flexible body in opposite directions in one degree of freedom (e. g, pitch degree of freedom motion).

The instrument handpiece <NUM> includes a manual action lever capstan system <NUM> similar to one of the lever capstan systems 616b/<NUM>, 616a/<NUM> of manual actuator <NUM> disclosed for <FIG>. The lever capstan system <NUM> is coupled to a single lever <NUM> for manual actuation by a user. Together the lever <NUM> and lever capstan system <NUM> form a manual actuator. The instrument handpiece <NUM> includes a drive input <NUM> movable by a drive system <NUM> to control the movement of the drive component 658a. The instrument handpiece <NUM> also includes a drive input <NUM> movable by a drive system <NUM> to control the movement of the opposing drive component 658b. The drive systems <NUM>, <NUM> are components of the robotic manipulator that includes the drive motors. The instrument handpiece <NUM> further includes a tensioning system <NUM> which prevents the opposing drive components 658a, 658b from becoming slack and decoupling from or entangling about the drive inputs or cable wheel system.

In use in manual mode, a clinician operates the single lever <NUM> to control both opposing motions for a single degree of freedom. For example, advancing the lever may move a distal end of the flexible body to pitch up and retracting the lever may move a distal end of the flexible body to pitch down. In robotic control mode, the instrument system <NUM> is coupled to a robotic manipulator for control in a manner similar to that described for instrument system <NUM>. In this embodiment, the drive system of the robotic manipulator controls only opposing motions for a single degree of freedom, e.g. pitch up and down. In alternative embodiments, a second drive input set and tensioning system, similar to that disclosed for instrument system <NUM> may be used to robotically control opposing motions for a second degree of freedom, e.g. yaw right and left.

<FIG> schematically illustrates such a second degree of freedom drive input set and tensioning system in an interventional instrument <NUM> and <FIG> illustrates an implementation of the interventional instrument schematically illustrated in <FIG>. The system <NUM> includes a catheter system <NUM> coupled to an instrument handpiece <NUM>. The catheter system <NUM> includes an elongated flexible body <NUM>. The flexible body <NUM> houses opposing drive components 683a, 683b for moving the distal end of the flexible body in opposite directions of a single degree of motion (e.g., pitch). The flexible body <NUM> also houses opposing drive components 685a, 685b for moving the distal end of the flexible body in opposite directions of another single degree of motion (e.g., yaw). The handpiece <NUM> includes a pitch control system <NUM> including drive inputs and a pitch tensioning system similar to that described for handpiece <NUM>. The handpiece <NUM> also includes a yaw control system <NUM> including drive inputs and a yaw tensioning system similar to that described for handpiece <NUM>. In this embodiment, a manual actuator <NUM> includes a single lever <NUM> mechanically linked to a pinion gear <NUM> that is mechanically engaged with gear racks <NUM>. The opposing pitch drive components 683a, 683b are coupled to the gear racks <NUM>.

In robotic control mode, the instrument system <NUM> may be operated substantially as described for instrument system <NUM>. In manual control mode, a clinician operates the lever <NUM>, for example with a thumb, to move the opposing pitch drive components 683a, 683b. In this embodiment, pivoting the lever <NUM> toward the distal end of the handpiece <NUM> rotates the gear <NUM>, causing the rack and pinion arms to move in opposite directions, thereby retracting the drive component 683b and advancing the drive component 683a. When the lever <NUM> is pivoted toward the proximal end of the handpiece <NUM>, the gear <NUM> rotates, causing the rack and pinion arms to move in opposite directions, thereby retracting the drive component 683a and advancing the drive component 683b.

In various embodiments, drive inputs in the handpiece may be coupled to the motorized drive system of the robotic interventional system so that in robotic control mode the drive inputs control multiple degrees of freedom (e.g., pitch and yaw) while in manual mode fewer degrees of freedom may be controlled by the manual actuator (e.g. pitch only). Alternatively, the same number of degrees of freedom can be controlled in both manual and robotic control.

<FIG> schematically illustrates an interventional instrument <NUM>. The instrument <NUM> includes a catheter system <NUM> coupled to an instrument handpiece <NUM>. The catheter system <NUM> houses opposing drive components 706a, 706b for moving the distal end of the flexible body in opposite directions in one degree of freedom (e. g, pitch degree of freedom motion). The instrument <NUM> has a gear and spring tensioning system <NUM> which prevents the opposing drive components 706a, 706b from becoming slack and decoupling from or entangling about the drive inputs or manual actuator. Similar tensioning systems <NUM>, <NUM> are used in instrument system <NUM>.

<FIG> illustrates a portion of the tensioning system <NUM> which includes a gear <NUM> coupled to a gear <NUM> by an idling gear <NUM>. The tensioning system <NUM> may be applied as the tensioning system in any of the instrument systems previously described. Gear <NUM> is rotatably coupled to a shaft <NUM> which is rotatably attached to the handpiece <NUM>. A biasing member <NUM>, such as a torsion spring, is coupled at one end to the gear <NUM> and at another end to a capstan <NUM> which is fixed to shaft <NUM>. The drive component 706b wraps around the capstan <NUM>. Similarly, gear <NUM> is rotatably coupled to a shaft <NUM> which is rotatably attached to handpiece <NUM>. A biasing member <NUM>, such as a torsion spring, is coupled at one end to the gear <NUM> and at another end to a capstan <NUM> which is fixed to shaft <NUM>. The drive component 706a wraps around the capstan <NUM>.

Capstan <NUM> is therefore compliantly coupled to capstan <NUM> through the gears <NUM>, <NUM>, <NUM> and the springs <NUM>, <NUM>. Further, drive component 706b is compliantly coupled through tensioning system <NUM> to the drive component 706a. When the gear and spring tensioning system <NUM> is assembled with a torsional preload on the springs <NUM>, <NUM> to apply tension to drive components 706a, 706b, the springs are able to compensate for slack that may develop between the drive components when, for example, the drive systems are decoupled and no torque is applied to the drive inputs. Tensioning systems such as <NUM> may also maintain tension between drive components (e.g., drive components 608a, 608b of handpiece <NUM>) when unequal motion of the drive components occurs due to friction and axial compliance in drive components 608a, 608b or catheter <NUM> or due to bending of catheter <NUM>.

In use, for example, when the pitch down drive component 706a is retracted (either through manual or robotic control), the opposing drive component 706b unfurls at least partially as capstan <NUM> rotates. Via the spring <NUM>, at least some of the torque on the capstan <NUM> is transferred to gear <NUM>. The torque on gear <NUM> applies torque to gear <NUM> in the same direction. The torque on the gear <NUM> is imparted at least partially, via spring <NUM> to capstan <NUM> to prevent any slack from appearing in opposing drive component 706a. Thus, opposing drive components 706a, 706b are maintained in tension. This use of the tensioning system <NUM> with unequal motions of opposing drive components may be particularly applicable in the instrument system <NUM> because the unequal motions of the drive components 608a, 608b can find their way past the split lever capstan system of manual actuator <NUM> to affect cable slack in the inputs.

<FIG> schematically illustrates an interventional instrument <NUM>. The instrument <NUM> includes a catheter system <NUM> coupled to an instrument handpiece <NUM>. The catheter system <NUM> houses opposing drive components 756a, 756b for moving the distal end of the flexible body in opposite directions in one degree of freedom (e. g, pitch degree of freedom motion). The instrument <NUM> has a cable tensioning system <NUM> which prevents the opposing drive components 756a, 756b from becoming slack and decoupling from the drive inputs or manual actuator.

<FIG> illustrates a portion of the tensioning system <NUM> which includes a capstan <NUM> coupled to a capstan <NUM> by a cable <NUM> fixed to and wound at least partially around the capstans. Capstan <NUM> is rotatably coupled to a shaft <NUM> which is rotatably attached to the handpiece <NUM>. A biasing member <NUM>, such as a torsion spring, is supported by the shaft <NUM> and coupled at one end to the capstan <NUM> and at another end to a capstan <NUM>. The drive component 756b wraps around the capstan <NUM>. Similarly, capstan <NUM> is rotatably coupled to a shaft <NUM> which is rotatably attached to the handpiece <NUM>. A biasing member <NUM>, such as a torsion spring, is coupled at one end to the capstan <NUM> and at another end to a capstan <NUM>. The drive component 756a wraps around the capstan <NUM>.

Pre-load wind-up of torsion springs <NUM>, <NUM> maintain tension in drive components 756a, 756b when no torque or lock is applied to the drive inputs or when unequal motions of the drive components would otherwise create slack. In use, for example, when the pitch down drive component 756a is retracted (either through manual or robotic control), the opposing drive component 756b unfurls at least partially as capstan <NUM> rotates. Via the spring <NUM>, at least some of the torque on the capstan <NUM> is transferred to capstan <NUM>. The torque on capstan <NUM> is imparted at least partially, via cable <NUM> to apply torque to capstan <NUM>. Torque on the capstan <NUM> is imparted at least partially through spring <NUM> to apply torque to capstan <NUM> to prevent any slack created in opposing drive component 756a. Thus, opposing drive components 756a, 756b are maintained in tension.

<FIG> schematically illustrates an interventional instrument <NUM>. The instrument <NUM> includes a flexible body <NUM> coupled to an instrument handpiece <NUM>. The flexible body <NUM> houses opposing drive components 806a, 806b for moving the distal end of the flexible body in opposite directions in one degree of freedom (e. g, pitch degree of freedom motion). The instrument <NUM> has a pulley and spring tensioning system <NUM> which prevents the opposing drive components 806a, 806b from becoming slack and decoupling from or entangling about the drive inputs or manual actuator.

<FIG> illustrates a portion of the tensioning system <NUM> which includes a pulley <NUM> fixed to the handpiece <NUM>. A biasing member <NUM>, such as an extension spring, is attached between the drive components 806a, 806b. At least one of the drive components 806a, 806b extends across the pulley <NUM>. In use, the spring <NUM> is pre-loaded so that if the movements of the drive components 806a, 806b are not equal or if no torque is applied to the inputs, at least some tension in both drive components is maintained. This insures that the drive components do not become disengaged from or entangled about the pulleys or capstans of the tensioning systems or the drive inputs or manual actuator.

In use, for example, when the pitch down drive component 756a is retracted (either through manual or robotic control), the opposing drive component 756b unfurls at least partially as capstan <NUM> rotates. Via the spring <NUM>, at least some of the torque is applied to the capstan <NUM> is transmitted to capstan <NUM>. The movement of capstan <NUM> is imparted at least partially, via cable <NUM> to rotate capstan <NUM>. Rotation of the capstan <NUM> is imparted at least partially through spring <NUM> to rotate capstan <NUM> to take up any slack created in opposing drive component 756a. Thus, opposing drive components 756a, 756b are maintained in tension.

<FIG> illustrates a method of use for an interventional instrument according to an embodiment of the present disclosure. An interventional instrument, such as any of those described in the preceding embodiments, is provided at <NUM>. At <NUM>, with the interventional instrument removed from the drive mechanism, the instrument may be operated in manual mode.

In manual mode, the manual actuator of the interventional instrument receives a force from the user (e.g., the pressure of a user's thumb against a thumb lever) to move the distal end of the elongated flexible instrument. When moved in a first direction (e.g. the thumb lever is toggled toward the distal end of the handpiece), the manual actuator moves a first drive component to control movement of a distal end of the elongated flexible shaft in a first direction (e.g., an upward pitch direction). When moved in a second direction (e.g., the thumb lever is toggled toward the proximal end of the handpiece), the manual actuator moves a second drive component to control movement of the distal end of the elongated flexible shaft in a second direction, opposite the first direction (e.g., a downward pitch direction).

At <NUM>, the interventional instrument is coupled to a robotic surgical system. More specifically, a motorized drive mechanism of a robotic surgical system receives a motor interface of the interventional instrument. Optionally, the motor interface of the interventional instrument is received at the drive mechanism in a direction approximately transverse to the longitudinal axis of the elongated shaft of the interventional instrument to minimize or eliminate motion of the instrument along its axis of insertion into the patient. At <NUM>, the drive input of the motorized mechanism is activated to move the distal end of the elongated flexible shaft in a first degree of freedom (e.g., pitch). In robotic control mode, one of a pair of drive inputs of the interventional instrument receives a force from the motorized drive system to move the distal end of the elongated flexible instrument. When activated, one of the pair of drive inputs moves a first drive component to control movement of a distal end of the elongated flexible shaft in a first direction (e.g., an upward pitch direction). When activated, the other one of the pair of drive inputs moves a second drive component to control movement of the distal end of the elongated flexible shaft in a second direction, opposite the first direction (e.g., a downward pitch direction).

At <NUM>, the motor interface of the interventional instrument is decoupled from the drive mechanism. Optionally, the motor interface of the interventional instrument is decoupled in a direction transverse to the longitudinal axis of the elongated shaft. Coupling and decoupling the instrument from the drive mechanism in a direction transverse to the shaft reduces the risk that the distal end interventional instrument will change insertion depth as the instrument moves between robotic control mode and manual control mode.

Although the systems and methods of this disclosure have been described for use in the connected bronchial passageways of the lung, they are also suited for navigation and treatment of other tissues, via natural or surgically created connected passageways, in any of a variety of anatomical systems including the colon, the intestines, the kidneys, the brain, the heart, the circulatory system, or the like. The methods and embodiments of this disclosure are also suitable for non-interventional applications.

One or more elements in embodiments of the invention may be implemented in software to execute on a processor of a computer system such as control system <NUM>. When implemented in software, the elements of the embodiments of the invention are essentially the code segments to perform the necessary tasks. The program or code segments can be stored in a processor readable storage medium or device that may have been downloaded by way of a computer data signal embodied in a carrier wave over a transmission medium or a communication link. The processor readable storage device may include any medium that can store information including an optical medium, semiconductor medium, and magnetic medium. Processor readable storage device examples include an electronic circuit; a semiconductor device, a semiconductor memory device, a read only memory (ROM), a flash memory, an erasable programmable read only memory (EPROM); a floppy diskette, a CD-ROM, an optical disk, a hard disk, or other storage device, The code segments may be downloaded via computer networks such as the Internet, intranet, etc..

Claim 1:
An interventional instrument (<NUM>), comprising:
an elongated flexible body (<NUM>) extending between a distal end and a proximal end;
a first pull wire (608a) extending within the elongated flexible body, the first pull wire actuatable to control articulation of the elongated flexible body, wherein the first pull wire extends within a first coiled sheath within the elongated flexible body;
a second pull wire (608b) extending within the elongated flexible body, the second pull wire actuatable to control articulation of the elongated flexible body; and
a handpiece (<NUM>) connected to the proximal end of the elongated flexible body, the handpiece configured to attach to a robotic manipulator (<NUM>), the handpiece comprising:
a first pulley (607a) positioned within the handpiece, wherein the first pull wire is positioned on the first pulley such that the first pulley rotates about an axis of a shaft and actuates the first pull wire to cause articulation of the elongated flexible body;
a second pulley (607b) positioned within the handpiece, wherein the second pull wire is positioned on the second pulley such that the second pulley rotates about an axis of a second shaft and actuates the second pull wire to cause articulation of the elongated flexible body;
a first manual actuator (616a) that rotates about the axis of the shaft and is connected to the first pulley such that manual rotation of the first manual actuator about the axis of the shaft causes rotation of the first pulley to cause articulation of the elongated flexible body; and
a first drive input (622a), separate from the first manual actuator, the first drive input configured to engage with a first motorized drive system of the robotic manipulator such that rotation of the first motorized drive system causes rotation of the first pulley to cause articulation of the elongated flexible body without acting through the first manual actuator; and
a second drive input (626a), the second drive input configured to engage with a second motorized drive system of the robotic manipulator such that rotation of the second motorized drive system causes rotation of the second pulley to cause articulation of the elongated flexible body.