Patent Description:
Minimally invasive medical techniques are intended to reduce the amount of tissue that is damaged during medical procedures, thereby reducing patient recovery time, discomfort, and harmful 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 physician may insert minimally invasive medical instruments (including surgical, diagnostic, therapeutic, or biopsy instruments) to reach a target tissue location. One such minimally invasive technique is to use a flexible and/or steerable elongate device, such as a flexible catheter, that can be inserted into anatomic passageways and navigated toward a region of interest within the patient anatomy. Flexible instruments may be inserted through the catheter to perform procedures at the target location. To prevent injury, certain types of tissues such as blood vessels, pulmonary pleura, and cardiac tissue should be avoided being punctured when deploying the flexible instruments. Supplemental sensing systems may be used to conduct more accurate procedures.

<CIT> discloses an endoscope observation device in which a tip of an insertion portion to be inserted into a body cavity is provided with a light emitting portion that irradiates light rays to a specimen and a light receiving portion that receives an observation light returning from the specimen for forming an image of the observation light received by the light receiving portion. The device comprises: a distance measurement unit that calculates an absolute distance between the tip of the insertion portion and the specimen through an interference of a low coherence light; a correction unit that corrects a piece of brightness information of the observation light based on the absolute distance calculated by the distance measurement unit; and an image forming unit that forms an image of the specimen based on the brightness information of the observation light corrected by the correction unit.

<CIT> discloses an apparatus for identifying tissue structures in advance of a mechanical medical instrument during a medical procedure. A mechanical tissue penetrating medical instrument has a distal end for penetrating tissue in a penetrating direction. An optical wavefront analysis system provides light to illuminate tissue ahead of the medical instrument and receives light returned by tissue ahead of the medical instrument. An optical fiber is coupled at a proximal end to the wavefront analysis system and attached at a distal end to the medical instrument proximate the distal end of the medical instrument. The distal end of the fiber has an illumination pattern directed substantially in the penetrating direction for illuminating the tissue ahead of the medical instrument and receiving light returned therefrom. The wavefront analysis system provides information about the distance from the distal end of the medical instrument to tissue features ahead of the medical instrument.

<CIT> discloses an Optical tomography system. Light emitted from the light source unit divided into measuring light and reference light. An optical path length of the measuring light or the reference light is adjusted and a probe guides the measuring light to an object. The reflected light from the object when the measuring light is projected onto the object and the reference light are multiplexed. Interference light of the reflected light and the reference light which have been multiplexed is detected, and a tomographic image of the object is obtained on the basis of the interference light. The probe is provided with a distance measuring circuit for measuring the distance from the probe to the object, and the optical path length of the measuring light or the reference light is adjusted by the use of the distance to the object measured by the distance measuring circuit to adjust the tomographic image obtainment initiating position.

<CIT> discloses a surgery assisting apparatus, comprising a probe, a treatment instrument and a detecting means. The probe includes one of either a magnetic-field generating element or a magnetic-field detecting element disposed in plural numbers inside an insertion portion to be inserted into a body of a subject. The treatment instrument includes the one of the either elements disposed by one or in plural numbers near a treatment portion for performing treatment on a target region of the subject. The detecting means is for detecting respective positions of the one of the either elements disposed in the probe and the one of the either elements disposed in the treatment instrument using a position of the other of the either elements as a benchmark, by disposing the other of the either magnetic-field generating element or the magnetic-field detecting element outside the subject.

<CIT> discloses a method for bringing an Optical Coherent Tomography (OCT) and IntraVascular UltraSound (IVUS) image into register. The method includes obtaining an IVUS image of an area of a lumen; obtaining an OCT image of the same area of the lumen; determining the same asymmetry in each of the IVUS and OCT images; and overlaying the IVUS and OCT images and rotating them with respect to one another until the asymmetry in each of the IVUS and OCT images are in register, and determining the angle of rotation that resulted in the registration. Also disclosed is a probe for OCT and IVUS imaging, the probe including a sheath having a first end and a second end defining a lumen; a marker that is opaque to light and ultrasound located between the first end and second end; and an IVUS/OCT probe head positioned within the sheath.

It is to be understood that the following detailed description is exemplary and explanatory in nature and is intended to provide an understanding of the present disclosure without limiting the scope of the present disclosure.

In the following description, specific details are set forth describing some embodiments consistent with the present disclosure. Numerous specific details are set forth in order to provide a thorough understanding of the embodiments. It will be apparent, however, to one skilled in the art that some embodiments may be practiced without some or all of these specific details. The specific embodiments disclosed herein are meant to be illustrative but not limiting. One skilled in the art may realize other elements that, although not specifically described here, are within the scope of the appended claims. In addition, to avoid unnecessary repetition, one or more features shown and described in association with one embodiment may be incorporated into other embodiments unless specifically described otherwise or if the one or more features would make an embodiment non-functional.

In some instances well known methods, procedures, components, and circuits have not been described in detail so as not to unnecessarily obscure aspects of the embodiments.

This disclosure describes 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-, and 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 object.

<FIG> is a simplified diagram of a teleoperated medical system <NUM> according to some embodiments. In some embodiments, teleoperated medical system <NUM> may be suitable for use in, for example, medical, surgical, diagnostic, therapeutic, or biopsy procedures. In some examples, teleoperated ,edical system may operate in a non-teleoperational manner under non-teleoperator control. As shown in <FIG>, medical system <NUM> generally includes a manipulator assembly <NUM> for operating a medical instrument <NUM> in performing various procedures on a patient P. Manipulator assembly <NUM> is mounted to or near an operating table T. A master assembly <NUM> allows an operator O (e.g., a surgeon, a clinician, or a physician as illustrated in <FIG>) to view the interventional site and to control manipulator assembly <NUM>.

Master assembly <NUM> may be located at an operator's console which is usually located in the same room as operating table T, such as at the side of a surgical table on which patient P is located. However, it should be understood that operator O can be located in a different room or a completely different building from patient P. Master assembly <NUM> generally includes one or more control devices for controlling manipulator assembly <NUM>. The control devices may include any number of a variety of input devices, such as joysticks, trackballs, data gloves, trigger-guns, hand-operated controllers, voice recognition devices, body motion or presence sensors, and/or the like. To provide operator O a strong sense of directly controlling instruments <NUM> the control devices may be provided with the same degrees of freedom as the associated medical instrument <NUM>. In this manner, the control devices provide operator O with telepresence or the perception that the control devices are integral with medical instruments <NUM>.

In some embodiments, the control devices may have more or fewer degrees of freedom than the associated medical instrument <NUM> and still provide operator O with telepresence. In some embodiments, the control devices may optionally be 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, and/or the like).

Manipulator assembly <NUM> supports medical instrument <NUM> and may include 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), a teleoperated kinematic structure, and/or a teleoperational manipulator. Manipulator assembly <NUM> may optionally include a plurality of actuators or motors that drive inputs on medical instrument <NUM> in response to commands from the control system (e.g., a control system <NUM>). The actuators may optionally include drive systems that when coupled to medical instrument <NUM> may advance medical instrument <NUM> into a naturally or surgically created anatomic orifice. Other drive systems may move the distal end of medical instrument <NUM> 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 in three degrees of rotational motion (e.g., rotation about the X, Y, Z Cartesian axes). Additionally, the actuators can be used to actuate an articulable end effector of medical instrument <NUM> for grasping tissue in the jaws of a biopsy device and/or the like. Actuator position sensors such as resolvers, encoders, potentiometers, and other mechanisms may provide sensor data to medical system <NUM> describing the rotation and orientation of the motor shafts. This position sensor data may be used to determine motion of the objects manipulated by the actuators.

Teleoperated medical system <NUM> may include a sensor system <NUM> with one or more sub-systems for receiving information about the instruments of manipulator assembly <NUM>. Such sub-systems may include a position/location sensor system (e.g., an electromagnetic (EM) sensor system); a shape sensor system for determining the position, orientation, speed, velocity, pose, and/or shape of a distal end and/or of one or more segments along a flexible body that may make up medical instrument <NUM>; and/or a visualization system for capturing images from the distal end of medical instrument <NUM>.

Teleoperated medical system <NUM> also includes a display system <NUM> for displaying an image or representation of the surgical site and medical instrument <NUM> generated by sub-systems of sensor system <NUM>. Display system <NUM> and master assembly <NUM> may be oriented so operator O can control medical instrument <NUM> and master assembly <NUM> with the perception of telepresence.

In some embodiments, medical instrument <NUM> may have a visualization system (discussed in more detail below), which may include a viewing scope assembly that records a concurrent or real-time image of a surgical site and provides the image to the operator O through one or more displays of medical system <NUM>, such as one or more displays of display system <NUM>. The concurrent image may be, for example, a two or three dimensional image captured by an endoscope positioned within the surgical site. In some embodiments, the visualization system includes endoscopic components that may be integrally or removably coupled to medical instrument <NUM>. However in some embodiments, a separate endoscope, attached to a separate manipulator assembly may be used with medical instrument <NUM> to image the surgical site. The visualization 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>.

Display system <NUM> may also display an image of the surgical site and medical instruments captured by the visualization system. In some examples, teleoperated medical system <NUM> may configure medical instrument <NUM> and controls of master assembly <NUM> such that the relative positions of the medical instruments are similar to the relative positions of the eyes and hands of operator O. In this manner operator O can manipulate medical instrument <NUM> and the hand control as if viewing the workspace in substantially true presence. By true presence, it is meant that the presentation of an image is a true perspective image simulating the viewpoint of an operator that is physically manipulating medical instrument <NUM>.

In some examples, display system <NUM> may present images of a surgical site recorded pre-operatively or intra-operatively using image data from imaging technology such as, computed tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, and/or the like. The pre-operative or intra-operative image data may be presented as two-dimensional, three-dimensional, or four-dimensional (including e.g., time based or velocity based information) images and/or as images from models created from the pre-operative or intra-operative image data sets.

In some embodiments, often for purposes of imaged guided surgical procedures, display system <NUM> may display a virtual navigational image in which the actual location of medical instrument <NUM> is registered (i.e., dynamically referenced) with the preoperative or concurrent images/model. This may be done to present the operator O with a virtual image of the internal surgical site from a viewpoint of medical instrument <NUM>. In some examples, the viewpoint may be from a tip of medical instrument <NUM>. An image of the tip of medical instrument <NUM> and/or other graphical or alphanumeric indicators may be superimposed on the virtual image to assist operator O controlling medical instrument <NUM>. In some examples, medical instrument <NUM> may not be visible in the virtual image.

In some embodiments, display system <NUM> may display a virtual navigational image in which the actual location of medical instrument <NUM> is registered with preoperative or concurrent images to present the operator O with a virtual image of medical instrument <NUM> within the surgical site from an external viewpoint. An image of a portion of medical instrument <NUM> or other graphical or alphanumeric indicators may be superimposed on the virtual image to assist operator O in the control of medical instrument <NUM>. As described herein, visual representations of data points may be rendered to display system <NUM>. For example, measured data points, moved data points, registered data points, and other data points described herein may be displayed on display system <NUM> in a visual representation. The data points may be visually represented in a user interface by a plurality of points or dots on display system <NUM> or as a rendered model, such as a mesh or wire model created based on the set of data points. In some examples, the data points may be color coded according to the data they represent. In some embodiments, a visual representation may be refreshed in display system <NUM> after each processing operation has been implemented to alter data points.

Teleoperated medical system <NUM> may also include control system <NUM>. Control system <NUM> includes at least one memory and at least one computer processor (not shown) for effecting control between medical instrument <NUM>, master assembly <NUM>, sensor system <NUM>, and display system <NUM>. Control system <NUM> also includes programmed instructions (e.g., a non-transitory machine-readable medium storing the instructions) to implement some or all of the methods described in accordance with aspects disclosed herein, including instructions operable to provide information to display system <NUM>. While control system <NUM> is shown as a single block in the simplified schematic of <FIG>, the system may include two or more data processing circuits with one portion of the processing optionally being performed on or adjacent to manipulator assembly <NUM>, another portion of the processing being performed at master assembly <NUM>, and/or the like. The processors of control system <NUM> may execute instructions comprising instruction corresponding to processes disclosed herein and described in more detail below. 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 teleoperational 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 receive force and/or torque feedback from medical instrument <NUM>. Responsive to the feedback, control system <NUM> may transmit signals to master assembly <NUM>. In some examples, control system <NUM> may transmit signals instructing one or more actuators of manipulator assembly <NUM> to move medical instrument <NUM>. Medical instrument <NUM> may extend into an internal surgical site within the body of patient P via openings in the body of patient P. Any suitable conventional and/or specialized actuators may be used. In some examples, the one or more actuators may be separate from, or integrated with, manipulator assembly <NUM>. In some embodiments, the one or more actuators and manipulator assembly <NUM> are provided as part of a teleoperational cart positioned adjacent to patient P and operating table T.

Control system <NUM> may optionally further include a virtual visualization system to provide navigation assistance to operator O when controlling medical instrument <NUM> during an image-guided surgical procedure. Virtual navigation using the virtual visualization system may be based upon reference to an acquired preoperative or intraoperative dataset of anatomic passageways. The virtual visualization system processes images of the surgical site imaged 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, and/or the like. Software, which may be used in combination with manual inputs, is used to convert the recorded images into segmented two dimensional or three dimensional composite representation of a partial or an entire anatomic organ or anatomic region. An image data set is associated with the composite representation. The composite representation and the image data set describe the various locations and shapes of the passageways and their connectivity. The images used to generate the composite representation may be recorded preoperatively or intra-operatively during a clinical procedure. In some embodiments, a virtual visualization system may use standard representations (i.e., not patient specific) or hybrids of a standard representation and patient specific data. The composite representation and any virtual images generated by the composite representation 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, sensor system <NUM> may be used to compute an approximate location of medical instrument <NUM> with respect to the anatomy of patient P. The location can be used to produce both macro-level (external) tracking images of the anatomy of patient P and virtual internal images of the anatomy of patient P. The system may implement one or more electromagnetic (EM) sensor, fiber optic sensors, and/or other sensors to register and display a medical implement together with preoperatively recorded surgical images. <CIT>) (disclosing "Medical System Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery") and <CIT>) (disclosing "Systems And Methods Of Registration For Image Guided Surgery") may teach systems that register and display a medical implement together with preoperatively recorded surgical images, such as those from a virtual visualization system. Teleoperated medical system <NUM> may further include optional operations and support systems (not shown) such as illumination systems, steering control systems, irrigation systems, and/or suction systems. In some embodiments, teleoperated medical system <NUM> may include more than one teleoperational manipulator assembly associated with more than one master assembly, and/or more than one non-teleoperational manipulator assembly. The exact number of teleoperational and/or non-teleoperational manipulator assemblies will depend on the surgical procedure and the space constraints within the operating room, among other factors. Master assembly <NUM> may be collocated or they may be positioned in separate locations. Multiple master assemblies allow more than one operator to control one or more teleoperational manipulator assemblies in various combinations.

<FIG> is a simplified diagram of a medical instrument system <NUM> according to some embodiments. In some embodiments, medical instrument system <NUM> may be used as medical instrument <NUM> in an image-guided medical procedure performed with teleoperated medical system <NUM>. In some examples, medical instrument system <NUM> may be used for non-teleoperational exploratory procedures or in procedures involving traditional manually operated medical instruments, such as endoscopy. Optionally medical instrument system <NUM> may be used to gather (i.e., measure) a set of data points corresponding to locations within anatomic passageways of a patient, such as patient P.

Medical instrument system <NUM> includes elongate device <NUM>, such as a flexible catheter, coupled to a drive unit <NUM>. Elongate device <NUM> includes a flexible body <NUM> having proximal end <NUM> and distal end or tip portion <NUM>. In some embodiments, flexible body <NUM> has an approximately <NUM> outer diameter. Other flexible body outer diameters may be larger or smaller.

Medical instrument system <NUM> further includes a tracking system <NUM> for determining the position, orientation, speed, velocity, pose, and/or shape of distal end <NUM> and/or of one or more segments <NUM> along flexible body <NUM> using one or more sensors and/or imaging devices as described in further detail below. The entire length of flexible body <NUM>, between distal end <NUM> and proximal end <NUM>, may be effectively divided into segments <NUM>. If medical instrument system <NUM> is consistent with medical instrument <NUM> of a teleoperated medical system <NUM>, tracking system <NUM>. Tracking system <NUM> may optionally 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 control system <NUM> in <FIG>.

Tracking system <NUM> may optionally track distal end <NUM> and/or one or more of the segments <NUM> using a shape sensor <NUM>. Shape sensor <NUM> may optionally include an optical fiber aligned with flexible body <NUM> (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 shape sensor <NUM> forms a fiber optic bend sensor for determining the shape of flexible body <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"). Sensors in some embodiments may employ other suitable strain sensing techniques, such as Rayleigh scattering, Raman scattering, Brillouin scattering, and Fluorescence scattering. In some embodiments, the shape of the elongate device may be determined using other techniques. For example, a history of the distal end pose of flexible body <NUM> can be used to reconstruct the shape of flexible body <NUM> over the interval of time. In some embodiments, tracking system <NUM> may optionally and/or additionally track distal end <NUM> using a position sensor system <NUM>. Position sensor system <NUM> may be a component of an EM sensor system with positional sensor system <NUM> including one or more conductive coils that may be subjected to an externally generated electromagnetic field. Each coil of EM sensor system <NUM> 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 some embodiments, position sensor system <NUM> 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 or five degrees of freedom, e.g., three position coordinates X, Y, Z and two orientation angles indicating pitch and yaw of a base point. Further description of a position sensor system is provided in <CIT>) (disclosing "Six-Degree of Freedom Tracking System Having a Passive Transponder on the Object Being Tracked").

In some embodiments, tracking system <NUM> may alternately and/or additionally rely on historical pose, position, or orientation data stored for a known point of an instrument system along a cycle of alternating motion, such as breathing. This stored data may be used to develop shape information about flexible body <NUM>. In some examples, a series of positional sensors (not shown), such as electromagnetic (EM) sensors similar to the sensors in position sensor system <NUM> may be positioned along flexible body <NUM> and then used for shape sensing. In some examples, a history of data from one or more of these sensors taken during a procedure may be used to represent the shape of elongate device <NUM>, particularly if an anatomic passageway is generally static.

Flexible body <NUM> includes a channel <NUM> sized and shaped to receive a medical instrument <NUM>. <FIG> is a simplified diagram of flexible body <NUM> with medical instrument <NUM> extended according to some embodiments. In some embodiments, medical instrument <NUM> may be used for procedures such as surgery, biopsy, ablation, illumination, irrigation, or suction. Medical instrument <NUM> can be deployed through channel <NUM> of flexible body <NUM> and used at a target location within the anatomy. Medical instrument <NUM> may include, for example, image capture probes, biopsy instruments, laser ablation fibers, and/or other surgical, diagnostic, or therapeutic tools. Medical tools may include end effectors having a single working member such as a scalpel, a blunt blade, an optical fiber, an electrode, and/or the like. Other end effectors may include, for example, forceps, graspers, scissors, clip appliers, and/or the like. Other end effectors may further include electrically activated end effectors such as electrosurgical electrodes, transducers, sensors, and/or the like. In various embodiments, medical instrument <NUM> is a biopsy instrument, which may be used to remove sample tissue or a sampling of cells from a target anatomic location. Medical instrument <NUM> may be used with an image capture probe also within flexible body <NUM>. In various embodiments, medical instrument <NUM> may be an image capture probe that includes a distal portion with a stereoscopic or monoscopic camera at or near distal end <NUM> of flexible body <NUM> for capturing images (including video images) that are processed by a visualization system <NUM> for display and/or provided to tracking system <NUM> to support tracking of distal end <NUM> and/or one or more of the segments <NUM>. The image capture probe may include a cable coupled to the camera for transmitting the captured image data. In some examples, the image capture instrument may be a fiber-optic bundle, such as a fiberscope, that couples to visualization system <NUM>. The image capture instrument may be single or multispectral, for example capturing image data in one or more of the visible, infrared, and/or ultraviolet spectrums. Alternatively, medical instrument <NUM> may itself be the image capture probe. Medical instrument <NUM> may be advanced from the opening of channel <NUM> to perform the procedure and then retracted back into the channel when the procedure is complete. Medical instrument <NUM> may be removed from proximal end <NUM> of flexible body <NUM> or from another optional instrument port (not shown) along flexible body <NUM>.

In this example, medical instrument <NUM> also includes an OCT imaging component <NUM> that provides OCT data to the visualization system <NUM>. The OCT imaging component <NUM> may be a sensing component for the forward imaging of tissue distal of the medical instrument. The depth of visualization with the OCT imaging component may depend of the quality of the component and the type of tissue distal of the medical instrument <NUM>. For example, in lung tissue, an OCT imaging component may provide visualization of tissue approximately <NUM>-<NUM> ahead of the component.

Medical instrument <NUM> may additionally house cables, linkages, or other actuation controls (not shown) that extend between its proximal and distal ends to controllably the bend distal end of medical instrument <NUM>. Steerable instruments are described in detail in <CIT>) (disclosing "Articulated Surgical Instrument for Performing Minimally Invasive Surgery with Enhanced Dexterity and Sensitivity") and <CIT>) (disclosing "Passive Preload and Capstan Drive for Surgical Instruments").

Flexible body <NUM> may also house cables, linkages, or other steering controls <NUM> that extend between drive unit <NUM> and distal end <NUM> to controllably bend distal end <NUM> as shown, for example, by broken dashed line depictions <NUM> of distal end <NUM>. In some examples, at least four cables are used to provide independent "up-down" steering to control a pitch of distal end <NUM> and "left-right" steering to control a yaw of distal end <NUM>. Steerable elongate devices are described in detail in <CIT>) (disclosing "Catheter with Removable Vision Probe"). In embodiments in which medical instrument system <NUM> is actuated by a teleoperational assembly, drive unit <NUM> may include drive inputs that removably couple to and receive power from drive elements, such as actuators, of the teleoperational assembly. In some embodiments, medical instrument system <NUM> may include gripping features, manual actuators, or other components for manually controlling the motion of medical instrument system <NUM>. Elongate device <NUM> may be steerable or, alternatively, the system may be non-steerable with no integrated mechanism for operator control of the bending of distal end <NUM>. In some examples, one or more lumens, through which medical instruments can be deployed and used at a target surgical location, are defined in the walls of flexible body <NUM>.

In some embodiments, medical instrument system <NUM> may include a flexible bronchial instrument, such as a bronchoscope or bronchial catheter, for use in examination, diagnosis, biopsy, or treatment of a lung. Medical instrument system <NUM> is also suited for navigation and treatment of other tissues, via natural or surgically created connected passageways, in any of a variety of anatomic systems, including the colon, the intestines, the kidneys and kidney calices, the brain, the heart, the circulatory system including vasculature, and/or the like.

The information from tracking system <NUM> may be sent to a navigation system <NUM> where it is combined with information from visualization system <NUM> and/or the preoperatively obtained models to provide the operator with real-time position information. In some examples, the real-time position information may be displayed on display system <NUM> of <FIG> for use in the control of medical instrument system <NUM>. In some examples, control system <NUM> of <FIG> may utilize the position information as feedback for positioning medical instrument system <NUM>. Various systems for using fiber optic sensors to register and display a surgical instrument with surgical images are provided in <CIT>, disclosing, "Medical System Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery,".

In some examples, medical instrument system <NUM> may be teleoperated within medical system <NUM> of <FIG>. In some embodiments, manipulator assembly <NUM> of <FIG> may be replaced by direct operator control. In some examples, the direct operator control may include various handles and operator interfaces for hand-held operation of the instrument.

<FIG> are simplified diagrams of side views of a patient coordinate space including a medical instrument mounted on an insertion assembly according to some embodiments. As shown in <FIG>, a surgical environment <NUM> includes a patient P is positioned on platform <NUM>. Patient P may be stationary within the surgical environment in the sense that gross patient movement is limited by sedation, restraint, and/or other means. Cyclic anatomic motion including respiration and cardiac motion of patient P may continue, unless patient is asked to hold his or her breath to temporarily suspend respiratory motion. Accordingly, in some embodiments, data may be gathered at a specific, phase in respiration, and tagged and identified with that phase. In some embodiments, the phase during which data is collected may be inferred from physiological information collected from patient P. Within surgical environment <NUM>, a point gathering instrument <NUM> is coupled to an instrument carriage <NUM>. In some embodiments, point gathering instrument <NUM> may use EM sensors, shape-sensors, and/or other sensor modalities. Instrument carriage <NUM> is mounted to an insertion stage <NUM> fixed within surgical environment <NUM>. Alternatively, insertion stage <NUM> may be movable but have a known location (e.g., via a tracking sensor or other tracking device) within surgical environment <NUM>. Instrument carriage <NUM> may be a component of a manipulator assembly (e.g., manipulator assembly <NUM>) that couples to point gathering instrument <NUM> to control insertion motion (i.e., motion along the A axis) and, optionally, motion of a distal end <NUM> of an elongate device <NUM> in multiple directions including yaw, pitch, and roll. Instrument carriage <NUM> or insertion stage <NUM> may include actuators, such as servomotors, (not shown) that control motion of instrument carriage <NUM> along insertion stage <NUM>.

Elongate device <NUM> is coupled to an instrument body <NUM>. Instrument body <NUM> is coupled and fixed relative to instrument carriage <NUM>. In some embodiments, an optical fiber shape sensor <NUM> is fixed at a proximal point <NUM> on instrument body <NUM>. In some embodiments, proximal point <NUM> of optical fiber shape sensor <NUM> may be movable along with instrument body <NUM> but the location of proximal point <NUM> may be known (e.g., via a tracking sensor or other tracking device). Shape sensor <NUM> measures a shape from proximal point <NUM> to another point such as distal end <NUM> of elongate device <NUM>. Point gathering instrument <NUM> may be substantially similar to medical instrument system <NUM>.

A position measuring device <NUM> provides information about the position of instrument body <NUM> as it moves on insertion stage <NUM> along an insertion axis A. Position measuring device <NUM> may include resolvers, encoders, potentiometers, and/or other sensors that determine the rotation and/or orientation of the actuators controlling the motion of instrument carriage <NUM> and consequently the motion of instrument body <NUM>. In some embodiments, insertion stage <NUM> is linear. In some embodiments, insertion stage <NUM> may be curved or have a combination of curved and linear sections.

<FIG> shows instrument body <NUM> and instrument carriage <NUM> in a retracted position along insertion stage <NUM>. In this retracted position, proximal point <NUM> is at a position L<NUM> on axis A. In this position along insertion stage <NUM> an A component of the location of proximal point <NUM> may be set to a zero and/or another reference value to provide a base reference to describe the position of instrument carriage <NUM>, and thus proximal point <NUM>, on insertion stage <NUM>. With this retracted position of instrument body <NUM> and instrument carriage <NUM>, distal end <NUM> of elongate device <NUM> may be positioned just inside an entry orifice of patient P. Also in this position, position measuring device <NUM> may be set to a zero and/or the another reference value (e.g., <NUM>=<NUM>). In <FIG>, instrument body <NUM> and instrument carriage <NUM> have advanced along the linear track of insertion stage <NUM> and distal end <NUM> of elongate device <NUM> has advanced into patient P. In this advanced position, the proximal point <NUM> is at a position L<NUM> on the axis A. In some examples, encoder and/or other position data from one or more actuators controlling movement of instrument carriage <NUM> along insertion stage <NUM> and/or one or more position sensors associated with instrument carriage <NUM> and/or insertion stage <NUM> is used to determine the position Lx of proximal point <NUM> relative to position L<NUM>. In some examples, position Lx may further be used as an indicator of the distance or insertion depth to which distal end <NUM> of elongate device <NUM> is inserted into the passageways of the anatomy of patient P.

A medical instrument system (e.g. system <NUM>) may be used to display anatomic passageways and target tissue for use in virtual navigation. The target tissue may be located near sensitive tissue structures that, if inadvertently pierced, may result in a failed procedure, patient injury, or patient death. For example with a medical procedure in lung tissue, virtual navigation may be used to access target tissue in remote airways, near the boundaries of lung tissue. These passageways may be close to sensitive tissue such as visceral and parietal pleura, fissure tissue, cardiac tissue such as the aorta, vasculature including the great vessel or other blood vessels, and musculature such as the diaphragm. These types of tissue may not be visible on a navigation display, real time image, or the location of the tissue structures in the preoperatively obtained images of the navigation display may be inaccurate. This creates the risk that a deployed medical instrument may pierce the sensitive tissue. For example, if a biopsy needle pierces through the pulmonary pleura, a pneumothorax may result. Although this example generally describes the use of a medical instrument for use in the airway passageways of lung tissue, it is understood that the same systems and techniques may be applied with other types of anatomic tissue.

Real-time imaging using ultrasound, CT, and/or fluoroscopic technology may be of limited use in assisting with robotic or non-robotic medical procedures. For example, ultrasound may provide low quality images through the parenchyma due to the presence of air in the passageways of lung tissue. CT equipment may not be available in interventional pulmonology environments and may be limited in providing real-time images. Fluoroscopy equipment may be limited in the type of tissue that can be imaged or is visible in images. Both CT and fluoroscopy emit levels of radiation that may be unacceptable for extended periods of time.

OCT imaging uses reflected light energy to create three dimensional images of local tissue structures. An OCT imaging component embedded in a medical instrument may be used to generate real-time images that alone or as supplementation to other navigation images may provide more accurate tissue location information and allow the medical instrument to avoid sensitive tissue structures. An OCT imaging component or sensor may include one or more optical fiber or other tracking sensors and optical components such as lenses, couplers, and mirrors for gathering real-time OCT images and providing them to the robotic control system for analysis and display.

<FIG> illustrates a medical instrument system <NUM> (e.g., system <NUM>) deployed within an anatomic passageway <NUM>. The system <NUM> includes a flexible catheter <NUM> and a flexible instrument <NUM> extending through the catheter. Either one or both of the catheter <NUM> and the instrument <NUM> may be robotically or manually steerable. The system <NUM> may be used to conduct a medical procedure, such as a biopsy on target tissue <NUM>. In this embodiment, target tissue <NUM> is outside of walls of the anatomic passageway <NUM> and located near sensitive tissue <NUM> which may be, for example, pulmonary pleura tissue. In this embodiment, the instrument <NUM> is a cannulated biopsy needle with a removable stylet <NUM> slidably extending through the biopsy needle and extendable distally of the distal end of the needle. The biopsy needle <NUM> may be used for sampling tissue from the target tissue <NUM>. The stylet <NUM> may extend within the needle as the needle is inserted through the catheter <NUM> and delivered through the passageway <NUM> to an area near the target tissue <NUM>. In this embodiment, the removable stylet is fitted near the distal tip with an OCT imaging component <NUM>. In this example, the OCT imaging component may be a forward imaging component for imaging the patient anatomy and tissue distal of the instrument. Images from the OCT imaging component may be used to steer the biopsy needle toward the target tissue, avoid the sensitive tissue <NUM>, or otherwise assist the physician in improving the accuracy and outcome of the biopsy procedure. After a desired catheter or needle depth is reached, as measured by the visualization and tracking systems alone or in combination with the OCT sensor information, the stylet may be removed After the stylet is removed, the needle lumen is open to perform a biopsy, for example by applying suction to vacuum a tissue sample into the needle lumen. The needle may be withdrawn and the tissue sample removed and analyzed. Alternatively, with the stylet removed, the needle may be used to deliver a therapeutic substance or an ablation device.

Optionally, the control system may be used to prevent the needle from advancing distally beyond a predefined maximum insertion depth. For example, the needle may be automatically driven by the robotic system to the predefined maximum insertion depth or an alert may be provided to the controller of a manually driven needle when the predefined maximum insertion depth is reached. In a hybrid teleoperational/manual or robotic/manual system, the operator may be alerted to stop manual or teleoperational advancement of the needle when the predefined maximum insertion depth is reached.

A removable stylet with integrated OCT imaging components, may be suitable in small needle constructions because removal of the stylet and the attached OCT imaging component from the needle may allow for a minimized outer diameter of the needle and maximized inner diameter of the needle lumen. The removable stylet may be used to position multiple biopsy instruments during a single procedure, allowing the cost of the OCT enabled stylet (which may also include shape sensor or EM sensor components) to be amortized over multiple biopsy instruments.

In alternative embodiments, the OCT imaging component may be fixed within the instrument <NUM>. For example, as shown in <FIG>, a side-imaging OCT instrument <NUM> (e.g., instrument <NUM> or stylet <NUM>) may include an outer wall <NUM> housing an optical assembly <NUM> which may include one or more optical fibers, lenses, filters, mirrors, or other optical components for directing a light beam <NUM> through a side aperture <NUM> in the outer wall. A light beam <NUM> emerging from the side aperture <NUM> may be used to perform the OCT imaging. In the example shown in <FIG>, a forward-facing OCT instrument <NUM> (e.g., instrument <NUM> or stylet <NUM>) may include an outer wall <NUM> housing an optical assembly <NUM> which may include one or more optical fibers, lenses, filters, mirrors, or other optical components for directing a light beam <NUM> through a distal aperture <NUM>. The light beam <NUM> emerging from the distal aperture <NUM> may be used to perform the OCT imaging.

In various embodiments, OCT imaging data from the instrument or stylet may be used to generate an OCT image for display to the physician for use in guiding the catheter <NUM> to a parking location near the target tissue <NUM> or for use in guiding the instrument <NUM> from the parked catheter <NUM> toward target tissue. <FIG> illustrates a method <NUM> for using OCT imaging data to profile tissue and transmit an information signal a component of a navigation system for display or navigational control. The method <NUM> is illustrated as a set of operations or processes <NUM>-<NUM>. Not all of the illustrated processes <NUM>-<NUM> may be performed in all embodiments of method <NUM>. Additionally, one or more processes that are not expressly illustrated in FIG. <NUM> may be included before, after, in between, or as part of the processes <NUM>-<NUM>. In some embodiments, one or more of the processes <NUM>-<NUM> are optional and may be omitted. All or only parts of the processes <NUM>-<NUM> described herein may be performed with robotic control including both teleoperated control and automatic control, or may be performed with manual control.

At a process <NUM>, the instrument <NUM> is advanced toward a target tissue <NUM>. The advancement may be fully automated, teleoperationally controlled, or manually controlled. For example, the instrument <NUM> may advance along a route established by the navigation system. At a process <NUM>, OCT imaging data is received from an OCT sensor (e.g. OCT imaging component <NUM> which may be either on the instrument or a stylet). In one example, the OCT image data is received after the catheter <NUM> and instrument <NUM> have been navigated to a park location within the anatomic passageway <NUM> near the target tissue <NUM>. The OCT imaging data may be used to visualize tissue beyond the wall of the anatomic passageway <NUM> in the vicinity of the park location. Optionally, the OCT image data may be used to generate a real-time image for display to the physician on a display screen (e.g., display <NUM>).

At a process <NUM>, the OCT imaging data is processed by the control system of the teleoperational system (e.g. the control system <NUM>) to profile the type of tissue in the OCT image data. The control system <NUM> may analyze the characteristics of the tissue in the OCT image data and match the characteristics with stored profiles of different types of tissue such as pleura tissue, cardiac tissue, vascular tissue, muscle tissue, bone tissue, and tumor tissue. Some types of profiled tissue may be characterized as sensitive tissue to be avoided by medical instruments.

At a process <NUM>, the navigation system uses the profile of the imaged tissue to assist the physician with subsequent steps in the medical procedure using the instrument <NUM>. One or more output information signals may be generated by the control system <NUM> based on the profile of the imaged tissue. The output information signal may, for example, provide information about the profiled tissue, the location of the profiled tissue, and/or the position of the profiled tissue relative to other tissues. The output signal may be sent to the navigation system, the display system, the drive system, an/or other components of the teleoperational or robotic system.

At a process <NUM>, if the imaged tissue includes tissue profiled as sensitive tissue <NUM>, a distance D between the imaging component <NUM> and the sensitive tissue <NUM> may be calculated. The location of the imaging component <NUM> may be kinematically known relative to the instrument <NUM>. Distance D may be displayed to the physician to help the physician avoid moving the instrument <NUM> into contact with the tissue <NUM>. The control system <NUM> may compare the distance D to a predefined safety distance and issue an auditory or visual alert when the distance D becomes smaller than the predefined safety distance, indicating that the instrument <NUM> has advanced too close to the sensitive tissue. In various embodiments, the navigation system of the robotic system may issue commands to suspend advancement of the robotic assembly and instrument drive systems to prevent the instrument <NUM> from advancing closer to the sensitive tissue than the predefined safety distance. Alternatively, suspending advancement may include sending the alert to warn an operator of a manually driven or teleoperationally driven instrument to suspend further advancement of the instrument. In various embodiments, the navigation system of the robotic system may issue commands to the robotic assembly and instrument drive systems to cause the instrument <NUM> to retract if it meets or exceeds the predefined safety distance, or issue an alert or notification to the user to manually or teleoperationally retract the assembly a predefined or recommended safe distance.

In various embodiments, the navigation system of the robotic system may issue commands to the robotic assembly and instrument drive systems to slow the velocity of the advancing instrument <NUM> as it approaches the predefined safety distance. For example, the navigation system may provide information indicating that the needle is approaching sensitive tissue such as the pleura, and the receipt of that information may trigger the OCT imaging system to begin imaging or begin analyzing images to identify the sensitive tissue in the OCT image data. This additional OCT data about the location of the sensitive tissue may be used to update registration with the anatomic model. Similarly, if analysis of the OCT image data indicates that sensitive tissue is not where it was predicted to be by the navigation system, that updated information may be used to update the registration.

Alternatively, the profile of the imaged tissue may be used to confirm the accuracy of the medical procedure. For example, if the instrument is a biopsy instrument, the profile of the OCT imaged tissue may provide feedback confirming that the target tissue has been sampled or alerting the physician that the target tissue was missed. Based on this feedback, the navigation system may provide guidance to the physician to move the catheter or instrument to access the target tissue by another approach or trajectory. Using the tissue profile information, the navigation system may suggest multiple biopsy locations in the target tissue. In another alternative, the accuracy of an ablation procedure may be confirmed by analysis of OCT image data that shows the tissue shows indications of ablation.

Although the OCT image data may be useful when the catheter is parked, as described, in alternative examples, the OCT image data may be used to improve navigation while the catheter <NUM> and instrument <NUM> are advancing within the passageway <NUM> toward the park location. For example, OCT image data may provide real-time images of lesions within the anatomic passages for avoidance or for performing a medical procedure.

One or more elements in embodiments of the invention (e.g., the processing of signals received from the input controls and/or control of the flexible catheter) 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 non-transitory machine-readable storage media, including any media that can store information including an optical medium, semiconductor medium, and magnetic medium. Machine-readable storage media 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. As described herein, operations of accessing, detecting, initiating, registered, displaying, receiving, generating, determining, moving data points, segmenting, matching, etc. may be performed at least in part by the control system <NUM> or the processors thereof.

Claim 1:
A system (<NUM>, <NUM>, <NUM>) for performing a minimally invasive procedure, the system comprising:
a flexible catheter (<NUM>, <NUM>) with a lumen extending therethrough;
a biopsy needle (<NUM>) sized for passage through the lumen;
an elongate instrument (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) sized for passage through the biopsy needle;
an optical coherence tomographic sensor (<NUM>, <NUM>, <NUM>, <NUM>) coupled to the elongate instrument; and
a control system (<NUM>) including one or more processors, wherein the control system is configured to:
receive sensor data from the optical coherence tomographic sensor;
profile a tissue (<NUM>, <NUM>) based on the received sensor data;
generate an output signal based on the profiled tissue; and
based on receipt of the output signal, determine a distance between the elongate instrument and the profiled tissue.