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 clinicians 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. Medical tools, such as biopsy instruments, are deployed through the catheter to perform a medical procedure at the region of interest. Medical tools are needed that are flexible enough to navigate the tight bends though the anatomic passageways while providing sufficient rigidity to ensure a predictable performance direction when deployed from the catheter.

<CIT> discloses a device for minimally invasive delivery of treatment substance. Systems, methods, and devices for delivering ablation fluid to a location of interest within a body (e.g., a location with the lung) are described. Ablation fluid delivery systems and devices can include flexible delivery needles within which a plurality of smaller flexible needles is housed. The smaller flexible needles can be configured to articulate or bend with respect to the flexible delivery needle to increase an effective delivery area for the ablation fluid. The smaller flexible needles can include apertures or other openings to facilitate delivery of the ablation fluid to the location of interest.

<CIT> discloses a bone marrow harvesting device including a flexible bone marrow harvesting needle that can bend during operation to prevent the needle tip from piercing the inner cortical wall of the target bone. The needle defines an aspiration channel that defines an intake end that is recessed to reduce the instances that the aspiration channel will be fouled by bone particles or other debris within the cancellous portion.

<CIT> discloses needles including elongate tubular cannulas having proximal portions, distal portions, and cannula walls defining cannula lumens. A distal portion of an elongate tubular cannula may include a distal end, one or more apertures disposed through, and along a first length of, the cannula wall in a pattern enhancing flexibility relative to a second length of the cannula wall lacking the apertures, and a sealing member disposed on the apertures. The apertures impart enhanced flexibility to the needle for navigating through tortuous pathways.

<CIT> discloses a minimally invasive system comprising an elongate sheath and an elongate instrument slidably disposed within a lumen of the sheath. The sheath includes a flexible tube portion including a plurality of slots, a sheath element, and a rigid tube section, wherein the flexible tube portion is fixedly coupled to a distal end of the sheath element, and the rigid tube section is fixedly coupled to a distal end of the flexible tube. The lumen extends through the sheath element, the flexible tube portion, and the rigid tube section and defines a longitudinal axis of the sheath. The instrument includes a rigid distal portion adapted to slide between a retracted configuration in which the rigid distal portion is retracted within the rigid tube section and an extended configuration in which the rigid distal portion at least partially extends from the rigid tube section.

<CIT> discloses an endoscopic instrument which comprises a first flexible insertion member sized for insertion through a body lumen to a target site and a needle coupled to the insertion member for penetration of tissue, the needle including a plurality of flexibility enhancing grooves formed therein along at least a first portion of the length of the needle. The preamble of claim <NUM> is based on this document.

<CIT> discloses an appliance for coronary artery dilation by PTCA, in which, when the guiding catheter is engaged with the coronary inlet part of the coronary artery and the appliance for dilation of the coronary artery is made to arrive at the deepest part of the coronary artery by the operation at the operator side, a cut groove of a suitable length heading toward the circumferential direction in the desired length range of an inside cylinder from the front end to the position near the coronary inlet part in the coronary artery or the mid-way position in the guiding catheter imparts a suitable elastic function to the inside cylinder, thereby preventing the increase in the pass resistance.

According to the present invention there is provided the medical tool of claim <NUM>. Additional aspects of the invention are set out in the dependent claims,.

The following description sets forth specific details describing some embodiments consistent with the present disclosure.

Consistent with some embodiments, a medical tool comprises an elongated tubular section having a body wall including a plurality of slits and a rigid needle tip coupled to a distal end of the tubular section. The tool further includes a flexible (e.g., polymer) jacket coupled with the elongated tubular section by extending into the plurality of slits which can, in some embodiments, block a fluid passageway through the plurality of slits.

Consistent with some non-claimed examples, a medical instrument system comprises a biopsy instrument including an elongated tubular section having a body wall including a plurality of slits, a rigid needle tip coupled to a distal end of the tubular section, and a flexible (e.g., polymer) jacket coupled to the elongated tubular section by extending into the plurality of slits which can, in some embodiments, block a fluid passageway through the plurality of slits. The instrument system also includes a sheath having a sheath channel sized to receive the biopsy instrument and includes a stylet formed of a super elastic material and sized to extend through the elongated tubular section and the rigid needle tip to straighten the elongated tubular section.

Consistent with some non-claimed examples, , a method comprises inserting a sheathed needle through a catheter and inserting a stylet through the needle. The stylet includes a superelastic material. The method also includes puncturing tissue with the needle and stylet; removing the stylet from the needle; applying a vacuum to the needle to collect a portion of the tissue inside the needle; and removing the needle and sheath from the catheter.

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

Master assembly <NUM> may be located at a physician'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 physician 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 teleoperational 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 physician 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 physician O with telepresence or the perception that the control devices are integral with medical instruments <NUM>.

In some examples, the control devices may have more or fewer degrees of freedom than the associated medical instrument <NUM> and still provide physician O with telepresence. In some examples, 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).

Teleoperational 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) and a teleoperational manipulator. Teleoperational 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 teleoperational 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 physician O can control medical instrument <NUM> and master assembly <NUM> with the perception of telepresence.

In some examples, 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 or physician 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 examples, the visualization system includes endoscopic components that may be integrally or removably coupled to medical instrument <NUM>. However in some examples, a separate endoscope, attached to a separate manipulator assembly may be used with medical instrument <NUM> to image the surgical site. In some examples, the endoscope may include one or more mechanisms for cleaning one or more lenses of the endoscope when the one or more lenses become partially and/or fully obscured by fluids and/or other materials encountered by the endoscope. In some examples, the one or more cleaning mechanisms may optionally include an air and/or other gas delivery system that is usable to emit a puff of air and/or other gassed to blow the one or more lenses clean. Examples of the one or more cleaning mechanisms are disclosed in greater detail in International Publication No. <CIT>)(disclosing "Systems and Methods for Cleaning an Endoscopic Instrument"). 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 physician O. In this manner physician 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 a physician 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 examples, 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 clinician or physician 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 physician O controlling medical instrument <NUM>. In some examples, medical instrument <NUM> may not be visible in the virtual image.

In some examples, 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 clinician or physician 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 physician 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 examples, 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 for providing 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 teleoperational 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 examples, 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 teleoperational 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, teleoperational manipulator assembly <NUM>. In some examples, the one or more actuators and teleoperational 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 physician 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 examples, 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. , such as those from a virtual visualization system, are known. For example <CIT>) (disclosing "Medical System Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery") discloses one such 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 examples, teleoperated medical system <NUM> may include more than one teleoperational manipulator assembly and/or more than one master assembly. The exact number of 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 non-claimed examples. In some examples, 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 examples, 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 example, the optical fiber has a diameter of approximately <NUM>. In other examples, 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 examples 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 examples, 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 position sensor system <NUM> including 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 some examples, 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 examples, 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 <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 examples. In some examples, 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 examples, 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 examples, 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>. The movement of the medical instrument <NUM> relative to the flexible body <NUM> may be controlled by a manual device such as an operator controlled handle or may be driven by teleoperational control. In one example, a tool control device <NUM> is coupled to a proximal end of the instrument <NUM> to control movement of the instrument <NUM> within the channel <NUM>. A port <NUM> coupled to the flexible body <NUM> allows through passage of the instrument <NUM> into the channel <NUM>. In one example the tool control device may be a handle at the proximal end of the tool.

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 (not shown) 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 examples 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 examples, 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 examples, 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 physician or other 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 examples, teleoperational manipulator assembly <NUM> of FIG.

<NUM> 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 non-claimed examples. As shown in <FIG>, a surgical environment <NUM> includes a patient P is positioned on the table T of <FIG>. 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 examples, data may be gathered at a specific, phase in respiration, and tagged and identified with that phase. In some examples, 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 examples, 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 teleoperational manipulator assembly (e.g., teleoperational 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 examples, an optical fiber shape sensor <NUM> is fixed at a proximal point <NUM> on instrument body <NUM>. In some examples, 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 examples, insertion stage <NUM> is linear. In some examples, 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.

Medical tools used with the flexible body of the catheter system should be flexible enough to navigate the tight turns and bends in the patient anatomical passageways traced by the catheter system. For example, the catheter system may follow a curve radius of <NUM> or less.

However, some medical tools require localized rigidity to perform their intended medical function. A medical tool such as a biopsy instrument, for example, may require a rigid distal tip portion to puncture tissue and to allow penetration of dense or hardened tissue. Described below are medical tools, including biopsy instruments that are pliant enough to permit passage through tortuous passageways, while still providing sufficient distal rigidity to extend from the catheter along a generally straight trajectory aligned with the orientation of the distal end of the catheter. The medical tools described herein may be used with the medical instrument system <NUM>, including with catheter system <NUM>, or with another guidance system such as a bronchoscope.

<FIG> illustrates a medical tool <NUM> (e.g. a medical tool <NUM>). In this embodiment medical tool <NUM> is a biopsy tool, but in alternative embodiments, various other tools including treatment (e.g., ablation) or imaging tools may be used with the principles described herein. The biopsy tool <NUM> includes a biopsy needle <NUM> extended from a sheath <NUM>. The biopsy needle <NUM> and sheath <NUM> are coupled to a handle assembly <NUM> that allows a user to move the needle within and relative to the sheath. In one example, the biopsy needle is a <NUM> gauge needle having an approximately <NUM> outer diameter that extends within a sheath having an approximately <NUM> outer diameter. In other examples, the smaller or larger sized needles may be used with the principles of this disclosure. In some examples, the biopsy needle may be extended approximately <NUM> from the distal end of the sheath <NUM> to extract biopsy tissue.

<FIG> illustrates a distal section <NUM> of the needle <NUM>. The distal section <NUM> may be formed from a relatively rigid material including a metal or a rigid polymer. In this embodiment, the distal section <NUM> is formed from a stainless steel hypotube. The distal section <NUM> includes rigid portion <NUM> and flexible portion <NUM>. The rigid portion <NUM> includes a cutting surface <NUM> surrounding an opening <NUM> to a channel <NUM> that extends through the distal section <NUM>.

The flexible portion <NUM> includes one or more slits <NUM> that extend through the wall of the distal section <NUM> to the channel <NUM>, allowing the flexible portion to bend. The slits <NUM> may have a variety of circumferential configurations (as described below) that extend along the longitudinal length of the flexible portion <NUM>. For example, a single spiral slit may extend around the length of the flexible portion. Alternatively, an interrupted spiral slit pattern or an interrupted slit pattern, having a plurality of pitched or perpendicular slits (relative to the central longitudinal axis through the channel <NUM>), may be formed in the flexible portion <NUM>. The slits <NUM> may be formed by laser cutting of the tubular body of the distal section <NUM>.

In one example, the rigid portion <NUM> has a lancet point with a twelve degree angle. In one example, the rigid portion may be approximately <NUM>, but longer or shorter rigid portions may be suitable. In one example, the flexible portion <NUM> may be approximately <NUM> (<NUM> inches ) to <NUM> ( <NUM> inches ) long, but longer or shorter flexible portions may be suitable. In alternative examples, the needle may have a side opening through a lateral wall of the rigid portion to collect sheared tissue biopsy samples.

A flexible jacket <NUM> (also sleeve <NUM>) extends around and is coupled with the flexible portion <NUM>. The jacket may be formed from, for example, a polymer material and interlocks with the flexible portion <NUM> by extending into the slits. The flexible jacket <NUM> can be impervious to fluid and can act as a flexible barrier to fluid flow through the slits <NUM>. For example, if a vacuum is applied along the channel <NUM> to pull tissue and bodily fluids in through the opening <NUM>, the jacket <NUM> prevents flow of the tissue and fluids out of the channel <NUM> and through the wall of the flexible portion <NUM>. In one example, the jacket <NUM> may be formed from a thin polyethylene terephthalate (PET) heat shrink material that may be molded on to the flexible portion <NUM>. The heat shrink material interlocks with the flexible portion by flowing into the slits <NUM> and when cooled, frictionally anchoring the jacket to the flexible portion. In other words, when the jacket is heated, it shrinks into the slits and when cooled, is interlocked with the slits. In other examples, polyamide, polyimide, Pebax, polytetrafluorotheylene (PTFE), fluorinated ethylene propylene (FEP) and polyurethane may be used as the jacket material. In another embodiment, a thermoplastic tubing such as PEBAX with a low durometer (e.g. <NUM> D) may be molded (e.g., via thermal flow) into the slits, closing off the slits to allow a vacuum, but flexible enough to allow bending. During the thermal flow, a mandrel may be used in the ID of the needle to prevent the material flow into the channel.

The needle <NUM> also includes a flexible shaft <NUM> coupled to a proximal end of the distal section <NUM>. The shaft <NUM> extends into a portion of the slits. In one example, the shaft <NUM> may be formed from a flexible polymer that is coupled to the distal section <NUM> by melting into the slits <NUM> to mechanically lock the shaft to the distal section <NUM> of the needle <NUM>. At the joint <NUM> where the shaft <NUM> and distal section <NUM> are coupled, the jacket <NUM> is sandwiched between the shaft and the flexible portion <NUM>. Proximal of the rigid portion <NUM> the needle <NUM> is pliant due to the flexible shaft <NUM> and flexible portion <NUM>, allowing passage of the needle through tight bends in narrow anatomical passageways.

When the needle <NUM> passes through a tight bend in the catheter <NUM>, the jacket <NUM> may develop a set curve or permanently bent shape that that does not does not straighten completely when the needle <NUM> advances distally from the catheter <NUM>. This set curve may bias the emerging needle to curve away from the orientation of the distal end of the guiding catheter. Biopsy accuracy may rely upon a predictable straight-line needle trajectory aligned with the orientation of the distal end of the catheter. To straighten the needle <NUM> that has developed a set curve, a stylet <NUM> may extend through the channel <NUM> of the needle <NUM> into the rigid portion <NUM>. When the rigid portion <NUM> and flexible portion <NUM> advance from the catheter during a biopsy procedure, the stylet <NUM> directs the rigid portion in a straight trajectory aligned with the orientation of the distal end of the guiding catheter. The stylet may be made of a super elastic material that provides a reversible physical response to an applied stress, which can be enabled by a material phase transformation. Examples of superelastic materials include various shape-memory alloys including Nitinol. A stylet made of a superelastic material does not permanently retain a bent shape but rather returns to a pre-established straightened configuration after traversing a curve. Other wire materials such as hard tempered stainless steel may be used to form the stylet but a small diameter stainless steel stylet may be needed to prevent a permanent bend in the stylet. Such a small diameter wire would have a lower straightening force than the Nitinol wire and thus may not be as effective in straightening the distal end of the needle. The stylet <NUM> may extend through the needle <NUM> while puncturing tissue and may be removed to allow collection of tissue within the channel of the needle.

As illustrated in <FIG>, the sheath <NUM> protects the point of the needle <NUM> from damage while being inserted through the catheter and protects the internal surface of the guiding catheter channel from becoming damaged by the sharp tip of the needle. The sheath <NUM> is positioned around the point of the needle <NUM> while the pair are advanced together through the catheter to a target anatomical location. Once the sheath <NUM> and needle <NUM> are fully advanced and positioned at the distal end of the catheter, the rigid portion <NUM> is extended distally from the sheath <NUM> and the catheter toward the target tissue. After the biopsy, the needle <NUM> is retracted into the sheath <NUM>, and the needle and sheath are withdrawn from the catheter.

The sheath <NUM> may be formed of a flexible tubular shaped polymer. As shown in <FIG>, the central channel <NUM> of the sheath <NUM> may be fitted near a distal portion with a guard member <NUM> that prevents the point of the needle <NUM> from gouging the inner surface of the sheath or otherwise becoming caught in the sheath. It can also provide an otherwise flexible sheath with a stiffer portion which aids in guiding the needle in a straight trajectory when advancing past the sheath distal tip. The guard member <NUM> may be formed or stainless steel or another type of radiopaque material that may be visualized on fluoroscopic images. In alternative embodiments, the guard member <NUM> may be eliminated and the distal end of the sheath <NUM> may be formed of a hardened plastic providing stiffness, such as fiberglass reinforced plastic embedded with barium sulfate to additionally provide radiopacity.

When traversing tight bends, large amounts of friction may develop between the outer surface of the needle <NUM> and the inner surface of the sheath <NUM> that prevent or limit movement of the needle relative to the sheath. Referring again to <FIG>, surface features <NUM> (also "surface discontinuities <NUM>") may be formed on the outer surface of the needle <NUM> to minimize the surface area making contact between the outer surface of the needle and the inner surface of the sheath, thus reducing the friction. In the examples of <FIG>, the surface features <NUM> are longitudinal ribs formed on the outer surface of the shaft <NUM>. In these examples, the longitudinal ribs that form the features <NUM> extend generally parallel to a longitudinal axis A through the needle <NUM>. Other types of surface discontinuities may be used to reduce friction including ridges and spiked projections. The surface discontinuities may be integrally formed on the shaft of the needle or on a sleeve that fits over the needle. The sleeve may be formed of a polymer and may be coupled to the needle by heating the sleeve so that the sleeve polymer flows into the slits <NUM> to form a mechanical coupling of the cooled polymer within the slits. Thus, the sleeve also acts as a barrier to prevent the flow of fluids through the slits. In various examples, the j acket <NUM> may be removed from the length of the slits <NUM> that are bonded and sealed by the sleeve. The sleeve may be formed from a variety of materials that reduce friction and provide radiopaque properties. In one example, the sleeve may be formed from a polymer mix such as polymide <NUM> and barium sulfate. In alternative examples, the surface of the needle <NUM> may be smooth and the inner surface of the sheath may be formed with surface discontinuities to prevent friction between the sheath and the needle.

<FIG> is a side view of a distal end of a biopsy tool with a rigid portion 309A, which is substantially similar to rigid portion <NUM> and a flexible portion 310A including a slit pattern <NUM>. In this example, the rigid portion 309A has a lancet point beveled from one side of a hypotube. In this example, the slit pattern <NUM> is an interrupted spiral pattern. A continuous spiral pattern may allow deformable stretch or bend when the needle navigates tight bends, but an interrupted spiral pattern creates bending flexibility while limiting linear deformation and stretch. The angle of the spiral pattern may vary to provide a desired flexibility. For example, the slit pattern may have approximately <NUM> cuts per rotation with <NUM>° cut and <NUM>° uncut with a slight pitch of approximately <NUM> inches.

<FIG> is a side view of a distal end of a biopsy tool with a rigid portion 309B substantially similar to rigid portion <NUM> and a flexible portion 310B including a slit pattern <NUM>. In this example, the slit pattern <NUM> is a perpendicular slit pattern in which adjacent slits are alternated with a rotation of <NUM>°. Each slit is approximately perpendicular to the longitudinal axis of the needle. The spacing of the slit pattern may vary to provide a desired flexibility.

<FIG> is a side view of a distal end of a biopsy tool <NUM> with a curved distal end <NUM> and a distal point <NUM> centered along a centerline A1 through the biopsy tool. The curved distal end <NUM> and distal point <NUM> are part of a rigid portion <NUM> of the biopsy tool <NUM>. As compared to a lancet point that has a tendency to cause the tool to curve away from the beveled edge when advancing, placing the point <NUM> along the needle centerline A1 causes the needle to advance in a straight trajectory through tissue. The rigid portion <NUM> of the tool is coupled to a flexible portion <NUM> which may be the same or similar to any of the flexible, slitted portions described above. As compared to a lancet style needle that may curve and burrow into the sheath wall, displace a piece of the sheath into the patient, or become damaged and ineffective in penetrating tissue, the biopsy tool <NUM> with a centered point reduces the likelihood of catching on the inner wall of the sheath, especially when navigating tight curves.

<FIG> illustrates the handle assembly <NUM> which is an example of a tool control device <NUM>. Handle assembly <NUM> includes a handle body <NUM> slidingly coupled to a hollow shaft <NUM>. The hollow shaft <NUM> extends through a needle stop <NUM> and is fixedly coupled to a hub <NUM>. Hub <NUM> is slidingly coupled to a connector assembly <NUM>. As shown in <FIG>, the proximal end of the needle <NUM> is coupled to a tube <NUM> which may be a metal hypotube. The tube <NUM> extends through the hollow shaft <NUM> and is fixed within the handle body <NUM>. In one example, the tube is coupled to the handle body <NUM> by plastic overmolding. The proximal end of the sheath <NUM> is coupled to a distal end of the hollow shaft <NUM>. A catheter port <NUM> (e.g. port <NUM>) is coupled to a distal end of connector assembly <NUM>. The catheter port <NUM> may be in communication with the working channel <NUM> of the catheter system <NUM>.

Sliding movement of the hollow shaft <NUM> into and out of the handle body <NUM> may be restricted by the needle stop <NUM>. Multiple stop position markings along the shaft <NUM> are marked with alphanumeric or graphical markings <NUM>. As shown in <FIG>, spaced apart ratchet teeth <NUM> are arranged along an outer bottom wall of the shaft <NUM>. A needle stop key <NUM> locks the needle stop <NUM> to the shaft <NUM> via the ratchet teeth <NUM>. By depressing the needle stop key <NUM>, the key releases from the ratchet teeth <NUM>, allowing the needle stop <NUM> to be slid longitudinally along the shaft <NUM> to another ratchet position. After repositioning, the needle stop key <NUM> may be released and the needle stop <NUM> is locked in a different longitudinal location along the shaft <NUM>. The handle body <NUM> can then be slid along the shaft <NUM> until the distal end of the handle body abuts the proximal end of the needle stop. As the handle body <NUM> moves relative to the shaft <NUM>, the needle <NUM>, which is fixed to the body <NUM>, moves relative to the sheath <NUM>, which is fixed to the shaft <NUM>. The markings <NUM>, visible through an opening <NUM> in the needle stop <NUM>, indicate the depth of insertion of the needle <NUM> when the handle body <NUM> abuts the needle stop <NUM>.

The longitudinal position of the connector assembly <NUM> relative to the hub <NUM> is controlled by a connector <NUM>, such as a thumb screw, that engages a track <NUM> in the connector assembly. The distal end of the connector assembly <NUM> includes a quick connect key <NUM> that engages and releases the catheter port <NUM>. Thus, the position of the catheter port <NUM> relative to the hub <NUM> may be adjusted by sliding the connector assembly <NUM> and repositioning it relative to the hub <NUM>. The position of the connector assembly <NUM> relative to the hub may be locked by engaging the thumb screw against the track <NUM>.

<FIG> illustrates a non-claimed method <NUM> of using the medical tool <NUM>. The method <NUM> is illustrated in <FIG> as a set of operations or processes <NUM>-<NUM>. Not all of the illustrated processes <NUM>-<NUM> may be performed in all examples of method <NUM>. Additionally, one or more processes that are not expressly illustrated in <FIG> may be included before, after, in between, or as part of the processes <NUM>-<NUM>. In some examples, one or more of the processes <NUM>-<NUM> are optional and may be omitted.

At a process <NUM>, the needle <NUM>, the sheath <NUM>, and the stylet <NUM> may be advanced through a guidance system (e.g. the catheter system <NUM> or a bronchoscope) toward a target tissue area. The pointed distal tip of the needle <NUM> is covered by the sheath <NUM> during the advancement. At a process <NUM>, after the needle <NUM>, sheath <NUM>, and stylet <NUM> have reached the distal end of the guidance system. As the needle and sheath assembly are advanced to hit the wall of the anatomic passageway, further insertion force causes the pointed needle to continue advancing and to puncture the wall. The blunt sheath does not puncture the wall so the needle advances past the distal end of the sheath. Alternatively, the sheath <NUM> may be withdrawn from the pointed distal tip before the needle and stylet are advanced. The stylet <NUM> helps maintain alignment of the needle trajectory with the orientation of the distal end of the guidance system. At a process <NUM>, the stylet <NUM> is removed from the needle <NUM>. Optionally, a vacuum is applied to the needle to urge tissue and fluid into the needle <NUM>. Although the needle includes a slits in the needle wall to allow flexible bending of the needle, the slits are sealed by the j acket <NUM> which maintains the vacuum within the needle. At a process <NUM>, the needle <NUM> and sheath <NUM> are removed from the catheter and the biopsied contents of the needle are removed. Optionally, with the catheter in the same orientation or in a different orientation, the processes <NUM>-<NUM> may be repeated to obtain multiple biopsy samples from the target tissue area.

<FIG> illustrates a handle assembly <NUM> which is an example of a tool control device <NUM>. <FIG> illustrates an expanded configuration of the assembly <NUM>, and <FIG> illustrates a retracted configuration. Handle assembly <NUM> includes a handle body <NUM> slidingly coupled to a hollow shaft <NUM>. The hollow shaft <NUM> extends through a needle stop <NUM> and is fixedly coupled to a hub <NUM>. Hub <NUM> is slidingly coupled to a connector assembly <NUM>. The proximal end of the biopsy needle <NUM> is coupled to a tube (not shown) which may be a metal hypotube. The tube extends through the hollow shaft <NUM> and is fixed to the handle body <NUM>. In one example, the tube is coupled to the handle body <NUM> by plastic overmolding. The proximal end of the sheath <NUM> is coupled to a distal end of the hollow shaft <NUM>. A catheter may be coupled to a distal end of connector assembly <NUM>.

Sliding movement of the hollow shaft <NUM> into and out of the handle body <NUM> may be restricted by the needle stop <NUM>. Multiple stop position markings <NUM> along the shaft <NUM> are marked with alphanumeric or graphical markings. Spaced apart ratchet teeth <NUM> are arranged along an outer bottom wall of the shaft <NUM>. A needle stop key <NUM> locks the needle stop <NUM> to the shaft <NUM> by interfacing with the ratchet teeth <NUM>. By depressing the needle stop key <NUM>, the key releases from the ratchet teeth <NUM>, allowing the needle stop <NUM> to be slid longitudinally along the shaft <NUM> to another ratchet position. After repositioning, the needle stop key <NUM> may be released and the needle stop <NUM> is locked in a different longitudinal location along the shaft <NUM>. The handle body <NUM> can then be slid along the shaft <NUM> (with the shaft <NUM> sliding into the body <NUM>) until the distal end of the handle body abuts the proximal end of the needle stop. As the handle body <NUM> moves relative to the shaft <NUM>, the needle <NUM>, which is fixed to the body <NUM>, moves relative to the sheath <NUM>, which is fixed to the shaft <NUM>. The markings <NUM>, visible through an opening <NUM> in the needle stop <NUM>, indicate the depth of insertion of the needle <NUM> when the handle body <NUM> abuts the needle stop <NUM>. In this embodiment, the opening <NUM> is in a distal portion of the needle stop <NUM>, between the needle stop key <NUM> and the hub <NUM>.

The longitudinal position of the connector assembly <NUM> relative to the hub <NUM> is controlled by a connector <NUM>, such as a thumb screw, that engages a track <NUM> in the connector assembly. The distal end of the connector assembly <NUM> includes a connector key <NUM> that engages and releases the catheter. Further description of the keys <NUM>, <NUM> is provided below at <FIG>, <FIG>. Thus, the position of the catheter relative to the hub <NUM> may be adjusted by sliding the connector assembly <NUM> and repositioning it relative to the hub <NUM>. The position of the connector assembly <NUM> relative to the hub may be locked by engaging the connector <NUM> against the track <NUM>.

In one exemplary embodiment, the handle assembly <NUM> may be used to conduct a biopsy procedure as follows. The catheter (see, e.g. <FIG>) is coupled to the connector assembly <NUM>. With the connector <NUM> unlocked from the track <NUM>, the handle body <NUM>, shaft <NUM>, and hub <NUM> may be advanced distally, as a unit, relative to the connector body and catheter to position a distal end of the sheath within a patient anatomy. The sheath <NUM>, the biopsy needle <NUM>, and a stylet (e.g. stylet <NUM>) are advanced as an assembly with the handle body <NUM>. After the sheath <NUM> is positioned, the connector <NUM> may be tightened by frictionally engaging the track <NUM>. The stylet may be removed by pulling the stylet handle <NUM> from the handle body <NUM>. A biopsy may be performed by moving the needle stop <NUM> along the shaft <NUM> until the desired insertion distance is indicated in the opening <NUM>. To advance the needle <NUM> from the sheath <NUM>, the handle body <NUM> and needle <NUM> may be pushed distally into abutment with the needle stop <NUM>. Vacuum may be applied to capture tissue, and the needle <NUM> may be removed.

As shown in <FIG>, the handle assembly <NUM> is one type of medical tool that can be connected to a catheter housing <NUM> at a catheter port <NUM> (e.g., port <NUM>). The catheter port <NUM> includes a groove <NUM> and a flange <NUM> for coupling a connector key <NUM> to the port <NUM>. The catheter housing <NUM> is coupled to a proximal end of a catheter <NUM>. The catheter <NUM> extends through an instrument adapter <NUM> and an instrument carriage <NUM> (e.g., carriage <NUM>). The instrument carriage <NUM> moves along an insertion stage <NUM> (e.g., <NUM>) which may be part of a teleoperational manipulator. Other types of medical tools, including for example an image capture probe <NUM> or an ablation instrument may be connected to catheter port <NUM> to access the catheter <NUM> (e.g. be received within a lumen of the catheter <NUM>). The image capture probe <NUM> may be communicatively coupled to the carriage <NUM> by a cable <NUM> that conveys power, image data, instruction signals or the like. The image capture probe <NUM> may also be coupled through the carriage <NUM> to a fluid source that may convey a cleaning fluid via a conduit <NUM> to the probe <NUM>.

<FIG> illustrates a cross-sectional view of the connector assembly <NUM> including the connector key <NUM> and a connector housing <NUM>. <FIG> illustrates the connector key <NUM> in greater detail. The connector key <NUM> includes a round central member <NUM> coupled to a link portion <NUM>. Curved arms <NUM> are coupled at a top end to the link portion <NUM> so that the arms <NUM> curve around the central member <NUM>. The bottom end of each arm <NUM> includes an expanded portion <NUM>. The link portion <NUM> includes a finger grip surface <NUM> that is curved to receive a downward force F from a user's finger. The round central member <NUM> defines a channel <NUM>. A projection <NUM> extends from the central member <NUM> and into the channel <NUM>. The connector housing <NUM> includes a pair of guides <NUM> that extend on opposite sides of the central member <NUM>, between the central member <NUM> and the arms <NUM>. The connector also includes a central passage <NUM>. The guides include a stop member <NUM> that limits movement of the expanded portion <NUM> of the arm <NUM> in a direction opposite the force F. As shown in <FIG>, without a force applied to the connector key <NUM>, the projection <NUM> extends into the central passage <NUM>. When the port <NUM> extends in to the central passage <NUM>, the projection <NUM> projects into the groove <NUM> to lock the connector assembly <NUM> to the port <NUM>. As shown in <FIG>, when the force F is applied to the connector key <NUM>, the arms <NUM> bend elastically outward, away from the central member <NUM> and the projection <NUM> recessed out of the central passage <NUM>. The movement of the arms <NUM> may be directed by the guides <NUM> and the stop members <NUM>. With the projection recessed from the central passage <NUM> is also becomes removed from the groove <NUM>, thus allowing the port <NUM> to become decoupled from the connector assembly <NUM>. When the force F is removed, the arms <NUM> are biased to move inward toward the central member <NUM>. To prevent the key <NUM> from becoming removed from the housing <NUM>, the stop members <NUM> limit movement of the expanded portions <NUM> of the arms <NUM> in the direction opposite the force F. In one example, the connector assembly <NUM> can be included on an adaptor (not shown) configured to connect the medical tool (e.g. biopsy tool <NUM>, image capture probe, or ablation instrument) to catheter port <NUM> to access the catheter <NUM>.

<FIG> illustrates a cylindrical section <NUM> of a biopsy needle having an irregular spiral or helical interrupted slit pattern <NUM> in a needle wall <NUM>. To better depict the slit pattern, the cylindrical section <NUM> may be sectioned longitudinally along an axis <NUM> extending along the wall <NUM>. <FIG> illustrates a cylindrical wall section <NUM> of a biopsy needle sectioned or "cut" longitudinally as shown in <FIG> to illustrate the slit pattern <NUM>. As shown in <FIG>, the wall section <NUM> is "unrolled" into a planar form view to illustrate a slit pattern <NUM>. The slit pattern <NUM> has at least one physical parameter that is progressively altered as the pattern progresses from a proximal to a distal end of the wall section. This changing physical parameter causes the flexibility of the cylindrical section to change from the proximal end to the distal end of the wall section. For example, as shown in the enlarged view of wall section <NUM> in <FIG>, the physical parameter may be a slit length. To decrease the flexibility from the proximal end to the distal end of wall section <NUM>, slit S1 has a length greater than slit S2 which has a length greater than slit S3 which has a length greater than slit S4. The longer slits at the proximal end provide greater flexibility, and the shorter slits at the distal end provide relatively greater rigidity. As another example, as shown in the enlarged view of wall section <NUM> in <FIG>, the physical parameter may be a bridge length of the bridging wall material between ends of sequential slits. To decrease the flexibility from the proximal end to the distal end of wall section <NUM>, bridge B1 has a length shorter than bridge B2 which has a length shorter than bridge B3 which has a length shorter than bridge B4. The shorter bridge lengths at the proximal end provide greater flexibility, and the longer bridge lengths at the distal end provide relatively greater rigidity. As another example, as shown in the enlarged view of wall section <NUM> in <FIG>, the physical parameter may be an angle of the slit relative to the longitudinal axis. To decrease the flexibility from the proximal end to the distal end of wall section <NUM>, slit S1 is cut at an angle (e.g., <NUM>°) greater than slit S2 (e.g., <NUM>°) which is greater than the angle of slit S3 (e.g., <NUM>°). The larger slit angles at the proximal end provide greater flexibility, and the smaller slit angles at the distal end provide relatively greater rigidity. More than one physical parameter may be altered in a needle section to provide the necessary gradation in flexibility. Other physical parameters that may be progressively altered to change the section flexibility include the pitch of the slit pattern, the width of the slits, and the angle of the helical pattern. To provide a smooth helical curve, the slits in the slit pattern may be cut on a curve which may be progressively altered. <FIG> illustrates a wall section <NUM> having a curved slit pattern <NUM> with each cycle of the helical rotation progressively increased from the proximal end of the section to the distal end of the section.

<FIG> illustrates a side views of a rigid distal portion <NUM> (e.g., rigid portion <NUM>) of a biopsy tool. The rigid distal portion <NUM> includes a distal cutting section <NUM> and a shaft portion <NUM>. The shaft portion <NUM> has a circular cross section and the cutting section <NUM> has an oblong or oval cross section created by a flattened and angled wall <NUM>. The cutting section <NUM> includes a cutting surface <NUM>. The circular volume of the portion <NUM> provides a large volume lumen to store large quantities of tissue. The oval or oblong cross section of the cutting section <NUM> may retain a sharp point for puncturing tissue while minimizing damage to the inner lumen wall of a sheath (e.g., sheath <NUM>) through which the distal portion <NUM> may be passed.

<FIG> illustrate a needle sheath <NUM> (e.g., sheath <NUM>) that includes an elongate tubular member <NUM> and guard member <NUM>. The elongate tubular member <NUM> includes a wall defining a channel <NUM>. The guard member <NUM> includes a head portion <NUM>, a tapered portion <NUM> and a tubular body portion <NUM>. The body portion <NUM> is sized to fit within the channel <NUM> and may be secured by, teeth on the body portion <NUM> or channel <NUM>, interlocking teeth on both body portion and channel, friction, or/or adhesive. The tapered portion <NUM> may also fit within the channel <NUM>. The head portion <NUM> may extend distally of the distal tip of the tubular member <NUM>. The head portion may be tapered and may have a rounded edge to prevent tissue injury. The tubular member <NUM> may be formed from a flexible material such as Pebax that may be mixed with a lubricious material to allow the sheath to slide easily within the catheter. The guard member <NUM> may be made of a more rigid material than the tubular member <NUM>. Suitable material may include metal or hardened plastic that resists damage by the point of a biopsy needle. The tubular member or the guard member may include a radiopaque marker to guide movement of the biopsy needle in the patient anatomy.

The sheath <NUM> may be contoured with a distal dip to permit greater bending and navigability of the distal end of the sheath <NUM>. In one embodiment, the tubular member <NUM> may have a proximal wall thickness T1, an intermediate wall thickness T2, and a distal wall thickness T3. The guard member <NUM> may have a maximum wall thickness T4. The wall thicknesses T1, T3, and T4 are greater than the wall thickness T2 to provide a narrowed or hourglass shape to the sheath. In an alternative embodiment, the wall thicknesses T1 and T4 are greater than the wall thickness T2, and the thickness T3 may be greater than, the same as or less than the wall thickness T2.

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 medical tool (<NUM>) comprising:
an elongated tubular section (<NUM>, 310A, 310B, <NUM>) having a body wall including a plurality of slits (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>);
a rigid needle tip (<NUM>, 309A, 309B, <NUM>, <NUM>) coupled to a distal end of the elongated tubular section;
a flexible jacket (<NUM>) covering a portion of the elongated tubular section; and
an elongated flexible member (<NUM>) coupled to a proximal end of the elongated tubular section, wherein a distal portion of the elongated flexible member covers a proximal portion of the flexible jacket;
characterized in that
the flexible jacket extends into a first portion of slits of the plurality of slits and a proximal portion of the elongated flexible member extends into a second portion of slits of the plurality of slits, and wherein the second portion of slits is not covered by the flexible jacket.