Compliant biopsy needle system

Abstract

The present application is entitled "Compliant biopsy needle system." A medical tool includes an elongate tubular section having a body wall comprising a plurality of slits and a rigid needle tip coupled to a distal end of the tubular section. The tool further includes a flexible sheath coupled with the elongate tubular section by extending into the plurality of slits to block fluid passage through the plurality of slits.

Description

[0001] This application is a divisional application of Chinese patent application 201780003150.X (PCT / US2017 / 035268) entitled “Compliant Biopsy Needle System”, filed on May 31, 2017.

[0002] Cross-references to related applications

[0003] This application claims priority and benefit on the filing date of U.S. Provisional Patent Application 62 / 343,596, entitled “PLIANT BIOPSY NEEDLE SYSTEM”, filed May 31, 2016, which is incorporated herein by reference in its entirety. Technical Field

[0004] This disclosure relates to systems and methods for delivering compliant biopsy needles via anatomical pathways. Background Technology

[0005] Minimally invasive medical techniques aim to reduce the amount of tissue damaged during medical procedures, thereby reducing patient recovery time, discomfort, and harmful side effects. These techniques can be performed through natural openings in the patient's anatomy or through one or more surgical incisions. Through these natural openings or incisions, clinicians can insert minimally invasive medical instruments (including surgical, diagnostic, therapeutic, or biopsy instruments) to reach the target tissue location. One such minimally invasive technique uses flexible and / or steerable elongated devices, such as flexible catheters that can be inserted into anatomical pathways and navigated toward regions of interest within the patient's anatomy. Medical instruments (such as biopsy instruments) are deployed through the catheter to perform medical procedures at the region of interest. Sufficient flexibility is required to navigate through sharp bends in the anatomical pathway while simultaneously providing sufficient rigidity to ensure a predictable direction of execution when deployed from the catheter. Summary of the Invention

[0006] The claims appended to the specification best summarize embodiments of the invention.

[0007] According to some embodiments, a medical tool includes an elongated tubular segment and a rigid needle tip. The elongated tubular segment has a body wall comprising a plurality of slits, and the rigid needle tip is coupled to a distal end of the tubular segment. The tool further includes a flexible (e.g., polymer) sheath coupled to the elongated tubular segment by extending into the plurality of slits. In some embodiments, the flexible sheath is capable of blocking fluid pathways through the plurality of slits.

[0008] According to some embodiments, a medical device system includes a biopsy instrument comprising an elongated tubular segment, a rigid needle tip, and a flexible (e.g., polymer) sheath. The elongated tubular segment has a body wall including a plurality of slits. The rigid needle tip is coupled to a distal end of the tubular segment. The flexible sheath is coupled to the elongated tubular segment by extending into the plurality of slits. In some embodiments, the flexible sheath is capable of blocking fluid passages through the plurality of slits. The device system also includes a sheath and a core needle having a sheath channel sized to receive the biopsy instrument. The core needle is formed of a hyperelastic material and sized to extend through the elongated tubular segment and the rigid needle tip to straighten the elongated tubular segment.

[0009] According to some embodiments, a method includes inserting a sheath needle through a catheter and inserting a core needle through the needle. The core needle comprises a superelastic material. The method further includes: puncturing tissue using the needle and core needle; removing the core needle 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.

[0010] It should be understood that both the foregoing general description and the following detailed description are exemplary and explanatory in nature and are intended to provide an understanding of the disclosure rather than to limit its scope. In this regard, additional aspects, features, and advantages of the disclosure will be apparent to those skilled in the art from the following detailed description. Attached Figure Description

[0011] Figure 1 This is a simplified schematic diagram of a remotely operated medical system according to some embodiments.

[0012] Figure 2A This is a simplified schematic diagram of a medical device system according to some embodiments.

[0013] Figure 2B This is a simplified schematic diagram of a medical device with extended medical tools according to some embodiments.

[0014] Figure 3A and Figure 3B This is a simplified schematic diagram of a side view of a medical device mounted on an insert assembly, according to some embodiments, in patient coordinate space.

[0015] Figure 4 This is a perspective view of a medical tool according to some embodiments.

[0016] Figure 5A This is a transparent side view of the distal end of a biopsy tool according to some embodiments.

[0017] Figure 5B It was retracted into the sheath. Figure 5AA transparent side view of the distal end of the biopsy tool.

[0018] Figure 5C This is an end view of a tool shaft with surface discontinuities.

[0019] Figure 6 This is a cross-sectional view of the distal end of a sheath according to some embodiments.

[0020] Figure 7A This is a side view of the distal end of a biopsy tool with a slit pattern according to one embodiment.

[0021] Figure 7B This is a side view of the distal end of a slit-style biopsy tool according to another embodiment.

[0022] Figure 8 This is a side view of the distal end of a biopsy tool with a centrally located needle tip, according to another embodiment.

[0023] Figure 9 This is a perspective view of the proximal end of a medical tool according to some embodiments.

[0024] Figure 10A yes Figure 8 A sectional view of the proximal end of a medical instrument.

[0025] Figure 10B This is the bottom view of the hollow axis.

[0026] Figure 11 This is a flowchart illustrating a method for using a medical device system according to some embodiments.

[0027] Figure 12A and Figure 12B This is a perspective view of the proximal end of a medical tool according to some embodiments. Figure 12B The diagram illustrates the retracted configuration of the medical device, and Figure 12A The illustration shows an expanded configuration of the medical device.

[0028] Figure 13 This illustrates the coupling of medical tools and medical device systems in a remotely operated medical system according to some embodiments.

[0029] Figure 14 A cross-sectional view of a connector assembly according to some embodiments is shown.

[0030] Figure 15A Show Figure 14 The connector key of the connector assembly.

[0031] Figure 15B Showing the uncompressed state Figure 14 Connector assembly.

[0032] Figure 15C Showing a compressed state Figure 14 Connector assembly.

[0033] Figure 16 The cylindrical section of the biopsy tool is shown.

[0034] Figure 17 The original cylindrical section of a biopsy tool, which is longitudinally cut and unfolded into a planar form according to some embodiments, is shown.

[0035] Figure 18 The original cylindrical section of a biopsy tool, which is longitudinally cut and unfolded into a planar form according to some embodiments, is shown.

[0036] Figure 19 Show Figure 17 The expanded section is the enlarged section of the expanded section.

[0037] Figures 20a and 20b show a side view and a top view of the rigid distal tip of a biopsy tool according to some embodiments, respectively.

[0038] Figure 21 and Figure 22 The distal end of the sheath is shown according to some embodiments.

[0039] Examples of this disclosure and its advantages will be best understood by referring to the following detailed description. It should be appreciated that the same reference numerals are used to identify the same elements illustrated in one or more of the figures, wherein the identification is for the purpose of illustrating embodiments of this disclosure and is not intended to limit this disclosure. Detailed Implementation

[0040] In the following description, specific details of some embodiments consistent with this disclosure are set forth. Numerous specific details are set forth in order to provide a full understanding of the embodiments. However, it will be apparent to those skilled in the art that some embodiments may be practiced without some or all of these specific details. The specific embodiments disclosed herein are intended to be illustrative and not restrictive. Other elements that are not specifically described herein but are within the scope and spirit of this disclosure can be implemented by those skilled in the art. Furthermore, to avoid unnecessary repetition, one or more features shown and described in connection with one embodiment may be incorporated into other embodiments unless otherwise specifically described or if one or more features would render the embodiment inoperable.

[0041] In some instances, well-known methods, procedures, components, and circuits are not described in detail so as not to unnecessarily obscure various aspects of the embodiments.

[0042] This disclosure describes the states of different instruments and instrument parts in three-dimensional space. As used herein, the term "position" refers to the location of an object or parts thereof in three-dimensional space (e.g., three translational degrees of freedom along Cartesian X, Y, and Z coordinates). As used herein, the term "orientation" refers to the rotational arrangement of an object or parts thereof (three rotational degrees of freedom—e.g., roll, pitch, and yaw). As used herein, the term "attitude" refers to the position of an object or parts thereof in at least one translational degree of freedom and the orientation of an object or parts thereof in at least one rotational degree of freedom (up to six degrees of freedom). As used herein, the term "shape" refers to a set of attitudes, positions, or orientations measured along the object.

[0043] Figure 1 This is a simplified schematic diagram of a remotely operated medical system 100 according to some embodiments. In some embodiments, the remotely operated medical system 100 may be adapted for use in procedures such as surgery, diagnosis, treatment, or biopsy. Figure 1 As shown, the medical system 100 generally includes a remote operating manipulator assembly 102 for operating the medical device 104 to perform various procedures on the patient P. The remote operating manipulator assembly 102 is mounted on or near the control panel T. The master control assembly 106 allows the operator (e.g., such as...) to... Figure 1 The surgeon, clinician, or physician (O) or assistant (surgeon) observes the intervention site and controls the remote manipulator assembly 102.

[0044] The master control assembly 106 may be located at a physician control console, which is typically situated in the same room as the operating table T, such as on one side of the surgical table on which the patient P is located. However, it should be understood that the physician O may be located in a different room or in a completely different building from the patient P. The master control assembly 106 generally includes one or more control devices 112 for controlling the remote-operated manipulator assembly 102. The control devices may include any number of various input devices, such as joysticks, trackballs, data gloves, trigger guns, manual operation controllers, voice recognition devices, body motion or presence sensors and / or similar devices. To provide the physician O with a strong sense of direct control over the instrument 104, the control devices 112 may be provided with the same degrees of freedom as the associated medical instrument 104. In this way, the control devices provide the physician O with a remote presentation or perception of the control devices and the medical instrument 104 as an integrated whole.

[0045] In some embodiments, the control device 112 may have more or fewer degrees of freedom than the associated medical device 104, while still providing remote presentation to the surgeon. In some embodiments, the control device 112 may optionally be a manual input device that moves in six degrees of freedom and may also include an actuable handle for actuating the device (e.g., closing grippers, applying a potential to electrodes, delivering medication and / or similar actions).

[0046] The remote-operated manipulator assembly 102 supports the medical device 104 and may include a motion structure of one or more non-servo-controlled links (e.g., one or more links that can be manually positioned and locked in place, often referred to as a set-up structure) and a remote-operated manipulator. The remote-operated manipulator assembly 102 optionally includes multiple actuators or motors that drive inputs on the medical device 104 in response to commands from a control system (e.g., control system 112). The actuators optionally include a drive system that, when coupled to the medical device 104, can advance the medical device into a natural or surgically created anatomical opening. Other drive systems may move the distal end of the medical device 104 with multiple degrees of freedom, which may include three linear degrees of freedom (e.g., linear motion along the X, Y, Z Cartesian coordinate axes) and three rotational degrees of freedom (e.g., rotation about the X, Y, Z Cartesian coordinate axes). Furthermore, the actuator can be used to actuate the articulated end effector of the medical device 104 to grasp tissue in the jaws of a biopsy device and / or similar device. Actuator position sensors (such as solvers, encoders, potentiometers, and other mechanisms) can provide the medical system 100 with sensor data describing the rotation and orientation of the motor shaft. This position sensor data can be used to determine the motion of the object manipulated by the actuator.

[0047] The remote-operated medical system 100 may include a sensor system 108 having one or more subsystems for receiving information about the instruments of the remote-operated manipulator assembly 102. These subsystems may include: a position / positioning sensor system (e.g., an electromagnetic (EM) sensor system); a shape sensor system for determining the position, orientation, velocity, rate, attitude, and / or shape along the distal end and / or one or more segments that may constitute the flexible body of the medical device 104; and / or a visualization system for acquiring images from the distal end of the medical device 104.

[0048] The remote-operated medical system 100 also includes a display system 110 for displaying images and representations of the surgical site and medical device 104 generated by a subsystem of the sensor system 108. The display system 110 and the main control assembly 106 can be oriented such that a physician O can control the medical device 104 and the main control assembly 106 under remotely presented perception.

[0049] In some embodiments, medical device 104 may have a visualization system (discussed in more detail below) that may include an observation endoscope assembly that records concurrent or real-time images of the surgical site and provides the images to an operator or physician O via one or more displays of medical system 100 (such as one or more displays of display system 110). The concurrent images may be, for example, two-dimensional or three-dimensional images acquired by an endoscope positioned within the surgical site. In some embodiments, the visualization system includes an endoscope component that may be integrally or removably coupled to medical device 104. However, in some embodiments, a separate endoscope attached to a separate manipulator assembly may be used in conjunction with medical device 104 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 one or more lenses are partially and / or completely blocked by fluids and / or other substances 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 can be used to emit a burst of air and / or other gas to clean one or more lenses. Examples of one or more cleaning mechanisms are disclosed in more detail in International Publication No. WO / 2016 / 025465 (filed August 11, 2016) (publication “Systems and Methods for Cleaning an Endoscopic Instrument”), which is incorporated herein by reference in its entirety. The visualization system can be implemented as hardware, firmware, software, or a combination thereof that interacts with or is executed by one or more computer processors (which may include the processor of control system 112).

[0050] Display system 110 can also display images of surgical sites and medical instruments acquired through a visualization system. In some examples, remote-operated medical system 100 can configure controls for medical device 104 and master assembly 106 such that the relative positions of the medical device are analogous to the relative positions of the doctor O's eyes and hands. In this way, doctor O can operate and manually control medical device 104 as if observing the workspace with a near-realistic sense of presence. "Realistic presentation" means that the images are presented as realistic perspective images simulating the viewpoint of a doctor physically manipulating medical device 104.

[0051] In some examples, the display system 110 can present images of surgical sites recorded preoperatively or intraoperatively using image data from imaging techniques such as computed tomography (CT), magnetic resonance imaging (MRI), fluorescence microscopy, thermal imaging, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, etc. The preoperative or intraoperative image data can be presented as two-dimensional, three-dimensional, or four-dimensional images (including, for example, time-based or velocity-based information), and / or as images from models generated from the preoperative or intraoperative image dataset.

[0052] In some embodiments, typically for the purpose of image-guided surgical procedures, the display system 110 may display a virtual navigation image in which the actual position of the medical device 104 is registered with preoperative or concurrent images / models (i.e., dynamic reference). This can be done to present a virtual image of the internal surgical site to the clinician or physician O from the perspective of the medical device 104. In some examples, the perspective may be from the tip of the medical device 104. Images and / or other graphic or alphanumeric indicators of the tip of the medical device 104 may be overlaid on the virtual image to aid the physician O in controlling the medical device. In some examples, the medical device 104 may be invisible in the virtual image.

[0053] In some embodiments, display system 110 may display a virtual navigation image in which the actual position of medical device 104 is registered with a preoperative or concurrent image to present a virtual image of medical device 104 within the surgical site to a clinician or physician O from an external perspective. An image of a portion of medical device 104 or other graphic or alphanumeric indicators may be overlaid on the virtual image to assist physician O in controlling medical device 104. As described herein, a visual representation of data points may be rendered onto display system 110. For example, measured data points, moving data points, registered data points, and other data points described herein may be displayed on display system 110 in a visual representation. Data points may be visually represented on the user interface as multiple points or dots on display system 110 or as a rendering model (such as a grid or wire model created based on a set of data points). In some examples, data points may be color-coded according to the data they represent. In some embodiments, the visual representation may be refreshed in display system 110 after each processing operation has been implemented to change the data points.

[0054] The remote-operated medical system 100 may also include a control system 112. The control system 112 includes at least one memory and at least one computer processor (not shown) for implementing control between the medical device 104, the main control assembly 106, the sensor system 108, and the display system 110. The control system 112 also includes programmed instructions (e.g., stored on a non-transitory machine-readable medium) to implement some or all of the methods described according to various aspects of the disclosure herein, including instructions for providing information to the display system 110. While the control system 112... Figure 1 The simplified schematic is shown as a single block, but the system may include two or more data processing circuits, with some processing optionally performed on or near the remote operating assembly 102, and other processing performed at the master control assembly 106 and / or similarly. The processor of the control system 112 may execute instructions, including instructions corresponding to the processing disclosed herein and described in more detail below. Any wide variety of centralized or distributed data processing architectures can be utilized. Similarly, programmable instructions may be implemented as several independent programs or subroutines, or they may be integrated into several other aspects of the remote operating system described herein. In one embodiment, the control system 112 supports wireless communication protocols such as Bluetooth, IrDA, HomeRF, IEEE 802.11, DECT, and wireless telemetry.

[0055] In some embodiments, the control system 112 may receive force and / or torque feedback from the medical device 104. In response to this feedback, the control system 112 may transmit a signal to the master assembly 106. In some examples, the control system 112 may transmit a command instructing one or more actuators of the remote operating manipulator assembly 102 to move the medical device 104. The medical device 104 may extend to an internal surgical site within the body of the patient P via an opening in the patient P's body. Any suitable conventional and / or specialized actuation may be used. In some examples, one or more actuators may be separate from or integrated with the remote operating manipulator assembly 102. In some embodiments, one or more actuators and the remote operating manipulator assembly 102 are provided as part of a remote operating trolley positioned adjacent to the patient P and the operating table T.

[0056] The control system 112 may optionally further include a virtual visualization system to provide navigational assistance to the physician O when controlling the medical device 104 during an image-guided surgical procedure. Virtual navigation using the virtual visualization system may be based on references to preoperative or intraoperative datasets of acquired anatomical pathways. The virtual visualization system processes images of the surgical site imaged using imaging techniques such as computed tomography (CT), magnetic resonance imaging (MRI), fluorescence microscopy, thermal imaging, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, etc. Software, which can be used in conjunction with manual input, is used to convert the recorded images into segmented two-dimensional or three-dimensional composite representations of local or global anatomical organs or regions. Image datasets are associated with composite representations. Composite representations and image datasets describe the various locations and shapes of pathways and their connectivity. Images used to generate composite representations may be recorded preoperatively or intraoperatively during the clinical procedure. In some embodiments, the virtual visualization system may use standard representations (i.e., not patient-specific) or a mixture of standard representations and patient-specific data. A composite representation and any virtual image generated from it can represent the static posture of a deformable anatomical region during one or more phases of motion (e.g., during the inspiratory / expiratory cycle of the lungs).

[0057] During the virtual navigation procedure, sensor system 108 can be used to calculate the approximate position of medical device 104 relative to the anatomical structure of patient P. This position can be used to generate a macroscopic horizontal (external) tracking image of the patient's anatomy and a virtual internal image of the patient P's anatomy. The system can implement one or more electromagnetic (EM) sensors, fiber optic sensors, and / or other sensors to register and display surgical images of the medical procedure and preoperative records, such as those from virtual visualization systems, which are known. For example, U.S. Patent Application No. 13 / 107,562 (filed May 13, 2011) (publishing "Medical System Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery") discloses such a system, which is incorporated herein by reference in its entirety. The remote-operated medical system 100 may further include optional operating and support systems (not shown), such as lighting systems, steering control systems, flushing systems, and / or suction systems. In some embodiments, the remote-operated medical system 100 may include more than one remote-operated manipulator assembly and / or more than one master control assembly. Among other factors, the exact number of remote-controlled manipulator assemblies will depend on the surgical procedure and the space constraints within the operating room. Master assemblies 106 can be collocated, or they can be positioned in separate locations. Multiple master assemblies allow more than one operator to control one or more remote-controlled manipulator assemblies in various combinations.

[0058] Figure 2A This is a simplified schematic diagram of a medical device system 200 according to some embodiments. In some embodiments, the medical device system 200 may be used as a medical device 104 in an image-guided medical procedure performed using a remotely operated medical system 100. In some examples, the medical device system 200 may be used in non-remotely operated exploratory procedures or in procedures involving conventionally manually operated medical devices (such as endoscopes). Optionally, the medical device system 200 may be used to collect (i.e., measure) a set of data points corresponding to locations within an anatomical pathway of a patient (such as patient P).

[0059] The medical device system 200 includes an elongated device 202, such as a flexible catheter, coupled to a drive unit 204. The elongated device 202 includes a flexible body 216 having a proximal end 217 and a distal or tip portion 218. In some embodiments, the flexible body 216 has an outer diameter of approximately 3 mm. Other flexible bodies may have larger or smaller outer diameters.

[0060] The medical device system 200 further includes a tracking system 230 for determining the position, orientation, velocity, rate, attitude, and / or shape of the distal end 218 and / or one or more segments 224 along the flexible body 216 using one or more sensors and / or imaging devices as described in further detail below. The entire length of the flexible body 216 between the distal end 218 and the proximal end 217 can be effectively divided into multiple segments 224. The tracking system 230 is used if the medical device system 200 is aligned with the medical device 104 of the remotely operated medical system 100. The tracking system 230 may optionally be implemented as hardware, firmware, software, or a combination thereof that interacts with or is executed by one or more computer processors, which may include... Figure 1 The processor of the control system 112.

[0061] Tracking system 230 may optionally use shape sensor 222 to track distal end 218 and / or one or more segments 224. Shape sensor 222 may optionally include an optical fiber aligned with flexible body 216 (e.g., provided within an internal channel (not shown) or externally mounted). In one embodiment, the optical fiber has a diameter of approximately 200 μm. In other embodiments, this size may be larger or smaller. The optical fiber of shape sensor 222 forms an optical fiber bending sensor for determining the shape of flexible body 216. In an alternative, optical fiber including fiber Bragg gratings (FBGs) is used to provide strain measurements in one or more dimensions of the structure. Various systems and methods for monitoring the shape and relative position of an optical fiber in three dimensions are described in U.S. Patent Application No. 11 / 180,389 (filed July 13, 2005) (publishing “Fiber optic position and shape sensing device and method relating thereto”); U.S. Patent Application No. 12 / 047,056 (filed July 16, 2004) (publishing “Fiber-optic shape and relative position sensing”); and U.S. Patent No. 6,389,187 (filed June 17, 1998) (publishing “Optical Fibre Bend Sensor”), which are incorporated herein by reference in their entirety. In some embodiments, the sensor 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 elongated device may be determined using other techniques. For example, the history of the distal attitude of the flexible body 216 can be used to reconstruct the shape of the flexible body 216 during that period. In some embodiments, the tracking system 230 may optionally and / or additionally use the position sensor system 220 to track the distal end 218. The position sensor system 220 may be a component of an EM sensor system, wherein the position sensor system 220 includes one or more conductive coils capable of withstanding an externally generated electromagnetic field. Each coil of the EM sensor system then generates an induced electrical signal having characteristics dependent on the position and orientation of the coil relative to the externally generated electromagnetic field. In some embodiments, the position sensor system 220 may be configured and positioned to measure six degrees of freedom (e.g., three position coordinates X, Y, Z and three orientation angles of pitch, yaw, and roll indicating a base point) or five degrees of freedom (e.g., three position coordinates X, Y, Z and two orientation angles of pitch and yaw indicating a base point).A further description of the position sensor system is provided in U.S. Patent No. 6,380,732 (filed August 11, 1999) (published "Six-Degree of FreedomTracking System Having a Passive Transponder on the Object Being Tracked"), which is incorporated herein by reference in its entirety.

[0062] In some embodiments, the tracking system 230 may alternatively and / or additionally rely on historical posture, position, or orientation data stored for known points of the instrument system along cycles of alternating movements (such as breathing). This stored data can be used to develop shape information about the flexible body 216. In some examples, a series of position sensors (not shown) (such as electromagnetic (EM) sensors similar to those in position sensor 220) may be positioned along the flexible body 216 and then used for shape sensing. In some examples, a history of data acquired during a procedure from one or more of these sensors may be used to represent the shape of the elongated device 202, particularly if the anatomical pathway is substantially static.

[0063] The flexible body 216 includes a channel that is sized and shaped to receive a medical device 226. Figure 2BThis is a simplified schematic diagram of a flexible body 216 with the medical device 226 extended, according to some embodiments. In some embodiments, the medical device 226 can be used for procedures such as surgery, biopsy, ablation, irradiation, perfusion, or aspiration. The medical device 226 can be deployed through channels 221 of the flexible body 216 and used at a target location within an anatomical structure. The medical device 226 may include, for example, an image acquisition probe, a biopsy instrument, a laser ablation fiber, and / or other surgical, diagnostic, or therapeutic tools. Medical tools may include end effectors with a single working component, such as scalpels, blunt blades, optical fibers, electrodes, etc. Other end effectors may include, for example, forceps, grippers, scissors, clamps, etc. Other end effectors may further include electrically activated end effectors, such as electrosurgical electrodes, transducers, sensors, etc. In various embodiments, the medical device 226 is a biopsy instrument that can be used to remove a sample of tissue or cells from a target structural location. The medical device 226 can be used in conjunction with an image acquisition probe also within the flexible body 216. In various embodiments, medical device 226 may be an image acquisition probe comprising a distal portion of a stereo camera or single-field-of-view camera having a distal portion at or near the distal end 218 of flexible body 216 for acquiring images (including video images), which are processed by visualization system 231 for display and / or provided to tracking system 230 to support tracking of one or more of distal end 218 and / or segments 224. The image acquisition probe may include a cable coupled to the camera for transmitting the acquired image data. In some examples, the image acquisition device may be a bundle of optical fibers, such as a fiber optic endoscope, coupled to visualization system 231. The image acquisition device may be monospectral or multispectral, for example, acquiring image data in one or more of the visible, infrared, or ultraviolet spectra. Alternatively, medical device 226 may itself be an image acquisition probe. Medical device 226 may be advanced from an opening in channel 221 to perform a procedure and then retracted into the channel when the procedure is complete. Medical device 226 may be removed from the proximal end 217 of flexible body 216 or from another optional device port (not shown) along flexible body 216. Movement of the medical device 226 relative to the flexible body 216 can be controlled by a manual device (such as an operator-controlled handle) or driven by a remotely operated control device. In one example, a tool control device 228 is coupled to the proximal end of the device 226 to control movement of the device 226 within the channel 221. A port 233 coupled to the flexible body 216 allows the device 226 to pass through into the channel 221. In one example, the tool control device may be a handle at the proximal end of the tool.

[0064] Medical device 226 may additionally accommodate a cable, linkage, or other actuation control device (not shown) extending between its proximal and distal ends to controllably bend the distal end of medical device 226. Steering devices are described in detail in U.S. Patent No. 7,316,681 (filed October 4, 2005) (published "Articulated Surgical Instrument for Performing Minimally Invasive Surgery with Enhanced Dexterity and Sensitivity") and U.S. Patent Application No. 12 / 286,644 (filed September 30, 2008) (published "Passive Preload and Capstan Drive for Surgical Instruments"), both of which are incorporated herein by reference in their entirety.

[0065] The flexible body 216 may also be accommodated between the drive unit 204 and the distal end 218 to controllably bend the cables, linkages, or other steering control devices (not shown), as illustrated, for example, by the dashed line 219 depicting the distal end. In some examples, at least four cables are used to provide independent control of the pitch "up and down" steering of the distal end 218 and the yaw "left and right" steering of the distal end 281. A steerable elongated device is described in detail in U.S. Patent Application No. 13 / 274,208 (filed October 14, 2011) (published "Catheter with Removable Vision Probe"), which is incorporated herein by reference in its entirety. In embodiments where the medical device system 200 is actuated by a remotely operated assembly, the drive unit 204 may include a drive input device that is removably coupled to a drive element (such as an actuator) of the remotely operated assembly and receives power from that drive element. In some embodiments, the medical device system 200 may include clamping features, manual actuators, or other components for manually controlling the movement of the medical device system 200. The elongated device 202 may be steerable, or alternatively, the system may be non-steerable without an integrated mechanism for operator control of bending of the distal end 218. In some examples, one or more cavities are defined within the walls of the flexible body 216, through which the medical device can be deployed and used at a target surgical site.

[0066] In some embodiments, the medical device system 200 may include flexible bronchial instruments, such as bronchoscopes or bronchial tubes for use in the examination, diagnosis, biopsy, or treatment of the lungs. The medical device system 200 is also suitable for navigating and treating other tissues via natural or surgically established access pathways within any of the various anatomical systems, including the colon, intestine, kidneys or renal calyces, brain, heart, circulatory system including the vascular system, etc.

[0067] Information from tracking system 230 can be sent to navigation system 232, where it is combined with information from visualization system 231 and / or a preoperatively acquired model to provide real-time location information to the physician or other operator. In some examples, the real-time location information can be displayed... Figure 1 The display system 110 is used for control of the medical device system 200. In some examples, Figure 1 The control system 116 can use position information as feedback to position the medical device system 200. Various systems for registering and displaying surgical instruments with surgical images using fiber optic sensors are disclosed in U.S. Patent Application No. 13 / 107,562, filed May 13, 2011, entitled "Medical System Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery," which is incorporated herein by reference in its entirety.

[0068] In some examples, the medical device system 200 can Figure 1 The medical system is operated remotely within 100. In some embodiments, Figure 1 The remote operating manipulator assembly 102 can be replaced by a direct operator control unit. In some examples, the direct operator control unit may include various handles and operator interfaces for handheld operation of the instrument.

[0069] Figure 3A and Figure 3B This is a simplified schematic diagram of a side view of a medical device mounted on an insert assembly, according to some embodiments, in patient coordinate space. Figure 3A and Figure 3B As shown, the surgical environment 240 includes the patient P being located in... Figure 1On the operating table T. Patient P can be stationary within the surgical environment in the sense of limiting significant patient movement through sedation, restraint, and / or other means. Periodic anatomical movements (including the breathing and cardiac movements of patient P) can continue unless the patient is instructed to hold their breath to temporarily halt respiratory movements. Therefore, in some embodiments, data can be collected at specific phases of breathing and used for tagging and identification. In some embodiments, the phase in which data is collected can be inferred from physiological information collected from patient P. Within the surgical environment 240, a point collection device 242 is coupled to an instrument holder 244. In some embodiments, the point collection device 242 can use an EM sensor, shape sensor, and / or other sensor modalities. The instrument holder 244 is mounted to an insertion stage 246 fixed within the surgical environment 240. Alternatively, the insertion stage 246 can be movable but has a known location within the surgical environment 240 (e.g., known via a tracking sensor or other tracking device). The instrument holder 244 may be a component of a remotely operated manipulator assembly (e.g., remotely operated manipulator assembly 102) coupled to the point-collecting instrument 242 to control insertion motion (i.e., movement along axis A) and optionally control movement of the distal end 256 of the elongated device 248 in multiple directions (including yaw, pitch, and roll). The instrument holder 244 or insertion stage 246 may include actuators (not shown), such as servo motors, for controlling movement of the instrument holder 244 along the insertion stage 246.

[0070] An elongated device 248 is coupled to an instrument body 250. The instrument body 250 is coupled to and secured relative to an instrument holder 244. In some embodiments, a fiber optic shape sensor 252 is secured at a proximal point 254 on the instrument body 250. In some embodiments, the proximal point 254 of the fiber optic shape sensor 252 may be movable together with the instrument body 250, but the location of the proximal point 254 may be known (e.g., known via a tracking sensor or other tracking device). The shape sensor 252 measures the shape from the proximal point 254 to another point (such as the distal end 256 of the elongated device 248). The point collection device 242 may be substantially similar to the medical device system 200.

[0071] As the instrument body 250 moves along the insertion axis A on the insertion stage 246, the position measuring device 258 provides information about the position of the instrument body 250. The position measuring device 258 may include a solver, encoder, potentiometer, and / or other sensors that determine the rotation and / or orientation of actuators that control the movement of the instrument carrier 244 and thus the movement of the instrument body 250. In some embodiments, the insertion stage 246 is linear. In some embodiments, the insertion stage 246 may be arcuate, or have a combination of arcuate and linear segments.

[0072] Figure 3A The device body 250 and device holder 244 are shown in their retracted position along the insertion stage 246. In this retracted position, the proximal point 254 is located at position L0 on axis A. In this position along the insertion stage 246, the A component of the position of the proximal point 254 can be set to zero and / or another reference value to provide a basic reference describing the position of the device holder 244 and therefore the proximal point 254 on the insertion stage 246. With the device body 250 and device holder 244 in this retracted position, the distal end 256 of the elongated device 248 can be positioned just inside the access port of the patient P. Also in this position, the position measuring device 258 can be set to zero and / or another reference value (e.g., I = 0). Figure 3B In this configuration, the instrument body 250 and instrument holder 244 have been advanced along the linear track of the insertion stage 246, and the distal end 256 of the elongated device 248 has been advanced into the patient P. In this advanced position, the proximal point 254 is located at position L1 on axis A. In some examples, encoder and / or other position data from one or more actuators controlling the movement of the instrument holder 244 along the insertion stage 246 and / or one or more position sensors associated with the instrument holder 244 and / or the insertion stage 246 are used to determine the position Lx of the proximal point 254 relative to position L0. In some examples, position Lx may further be used as an indicator of the distance or depth of insertion of the distal end 256 of the elongated device 248 into the anatomical structure of the patient P.

[0073] Medical instruments used with the flexible body of a catheter system should be sufficiently flexible to navigate sharp turns and bends in the patient's anatomical pathway followed by the catheter system. For example, the catheter system may follow curves with a radius of 13 mm or less. However, some medical instruments require localized rigidity to perform their intended medical function. Medical instruments (such as biopsy instruments) may require, for example, a rigid distal tip to puncture tissue and allow puncture of dense or hardened tissue. Medical instruments incorporating biopsy instruments are described below, which are sufficiently compliant to allow passage through meandering pathways while still providing sufficient distal rigidity to extend from the catheter along a generally straight trajectory aligned with the distal end of the catheter. The medical instruments described herein can be used with medical device system 200 (including with catheter system 202 or another guiding system, such as a bronchoscopy).

[0074] Figure 4 A medical tool 300 (e.g., medical tool 226) is shown. In this embodiment, the medical tool 300 is a biopsy tool, but in alternative embodiments, various other tools, including treatment (e.g., ablation) or imaging tools, can be used with the principles described herein. The biopsy tool 300 includes a biopsy needle 302 extending from a sheath 304. The biopsy needle 302 and the sheath 304 are coupled to a handle assembly 306 that allows the user to move the needle within and relative to the sheath. In one example, the biopsy needle is a 19-gauge needle with an outer diameter of approximately 1 mm extending within a sheath having an outer diameter of approximately 1.75 mm. In other examples, smaller or larger needles can be used with the principles of this disclosure. In some examples, the biopsy needle can extend approximately 3 cm from the distal end of the sheath 304 to extract biopsy tissue.

[0075] Figure 5A The distal segment 308 of needle 302 is shown. The distal segment 308 may be formed of a relatively rigid material including metal or a rigid polymer. In this embodiment, the distal segment 308 is formed of a stainless steel thiocyanate tube. The distal segment 308 includes a rigid portion 309 and a flexible portion 310. The rigid portion 309 includes a cut surface 311 surrounding an opening 312 to a channel 313 extending through the distal segment 308.

[0076] The flexible portion 310 includes one or more slits 314 that extend through the wall of the distal segment 308 to the channel 313, thereby allowing the flexible portion to bend. The slits 314 can have various circumferential configurations (as described below) extending along the longitudinal length of the flexible portion 310. For example, a single helical slit can extend around the length of the flexible portion. Alternatively, an interrupted helical slit pattern or an interrupted slit pattern with multiple slits that are sloped or perpendicular (relative to the central longitudinal axis through the channel 313) can be formed in the flexible portion 310. The slits 314 can be formed by laser cutting the tubular body of the distal segment 308.

[0077] In one example, the rigid portion 309 has a lancet point with a 12-degree angle. In one example, the rigid portion may be approximately 5 mm long, but longer or shorter rigid portions may be suitable. In one example, the flexible portion 310 may be approximately 1.2 to 1.8 inches long, but longer or shorter flexible portions may be suitable. In an alternative example, the needle may have a side opening through the transverse wall of the rigid portion to collect severed tissue biopsy samples.

[0078] A flexible sheath 318 (also referred to as sleeve 318) extends around and is coupled to the flexible portion 310. This sheath can be formed, for example, of a polymeric material adhered to and / or interlocked with the flexible portion 310 by extending into the slit. The flexible sheath 318 is fluid-impermeable and can act as a flexible barrier to fluid flow through the slit 314. For example, if a vacuum is applied along the channel 313 to pull tissue and fluid through the opening 312, the sheath 318 prevents tissue and fluid from flowing out of the channel 313 and through the wall of the flexible portion 310. In one example, the sheath 318 can be formed of a thin polyethylene terephthalate (PET) heat-shrinkable material that can be molded onto the flexible portion 310. This heat-shrinkable material interlocks with the flexible portion by flowing into the slit 314 and frictionally anchoring the sheath to the flexible portion when cooled. In other words, when the sheath is heated, it contracts into the slit and interlocks with the slit when cooled. In other examples, polyamides, polyimides, Pebax, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), and polyurethane can be used as sheath materials. In another embodiment, a thermoplastic tubing with a low Shore hardness (e.g., 35D) such as PEBAX can be molded into the slit (e.g., via thermal flow), closing the slit to allow a vacuum, but flexible enough to allow bending. During thermal flow, a mandrel can be used in the ID (inner diameter) of the needle to prevent material from flowing into the channel.

[0079] Needle 302 also includes a flexible shaft 316 coupled to the proximal end of distal segment 308. In one example, shaft 316 may be formed of a flexible material coupled to distal segment 308 by melting into slit 314 to mechanically lock the shaft to distal segment 308 of needle 302. In another example, shaft may be integrally formed with distal segment 308 and may include multiple slits along the length of shaft to allow shaft flexure. At joint 315 where shaft 316 and distal segment 308 are coupled, sheath 318 may extend over a portion of shaft or may be clamped between shaft and flexible portion 310. Due to the presence of flexible shaft 316 and flexible portion 310, needle 302 is pliant proximally to rigid portion 309, thereby allowing needle to pass through sharp bends in narrow anatomical pathways.

[0080] As the needle 302 passes through the sharp bend in the catheter 202, the sheath 318 can take on an arcuate or permanently bent shape that remains completely straight as the needle 302 is advanced distally from the catheter 202. This arcuate shape can bias the exposed needle away from the distal orientation of the guiding catheter. Biopsy accuracy can rely on a predictable straight needle trajectory aligned with the distal orientation of the catheter. To straighten the already arcuate needle 302, a core 320 can extend through the channel 313 of the needle 302 into the rigid portion 309. As the rigid portion 309 and the flexible portion 310 are advanced from the catheter during the biopsy procedure, the core 320 guides the rigid portion along a straight trajectory aligned with the distal orientation of the guiding catheter. The core can be made of a hyperelastic material that provides a reversible physical response to applied stress, which can be achieved through a material phase transition. Examples of hyperelastic materials include various shape memory alloys, including nitinol. The mandrel made of a hyperelastic material does not permanently retain its bent shape, but returns to a pre-established straight profile after passing through the arc. Other wire materials (such as hardened stainless steel) can be used to form the mandrel, but smaller diameter stainless steel may be required to prevent permanent bending within the mandrel. Such a small-diameter wire would have a lower straightening force than nitinol wire, and therefore be less effective in straightening at the distal end of the needle. The mandrel 320 can extend through the needle 302 while piercing the tissue and can be removed to allow tissue collection within the needle channel.

[0081] like Figure 5BAs shown, the sheath 304 protects the tip of the needle 302 from damage during insertion through the catheter and protects the inner surface of the guiding catheter channel from damage by the sharp tip of the needle. The sheath 304 is positioned around the tip of the needle 302, and the pair is advanced together through the catheter to the target anatomical location. Once the sheath 304 and needle 302 are fully advanced and positioned distally in the catheter, the rigid portion 309 extends distally from the sheath 304 and the catheter toward the target tissue. After the biopsy, the needle 302 is retracted into the sheath 304, and the needle and sheath are withdrawn from the catheter.

[0082] The sheath 304 can be formed from a flexible tubular polymer. For example... Figure 6 As shown, the central channel 334 of the sheath 304 can be fitted near the distal portion having a protective member 322, which prevents the tip of the needle 302 from scratching the inner surface of the sheath or becoming stuck in the sheath. It can also provide an additional flexible sheath with a stiffer portion that helps guide the needle along a straight trajectory when advanced past the distal tip of the sheath. The protective member 322 can be formed of stainless steel or another type of radiopaque material visible on a fluorescent imaging image. In an alternative embodiment, the protective member 322 can be omitted, and the distal end of the sheath 304 can be formed of a hardened plastic (such as glass fiber reinforced plastic embedded with barium sulfate) to provide additional radiopaqueness.

[0083] When passing through a sharp bend, significant friction may occur between the outer surface of the needle 302 and the inner surface of the sheath 304, preventing or limiting the movement of the needle relative to the sheath. (See again...) Figure 5B Surface feature 324 (“surface discontinuity 324”) can be formed on the outer surface of needle 302 to minimize the surface area of ​​contact between the outer surface of the needle and the inner surface of the sheath, thereby reducing friction. Figure 5B and Figure 5CIn the examples, surface feature 324 is a longitudinal rib formed on the outer surface of shaft 316. In these examples, the longitudinal rib forming feature 324 extends generally parallel to the longitudinal axis A passing through needle 302. Other types of surface discontinuities can be used to reduce friction, including ridges and spikes. Surface discontinuities can be integrally formed on the shaft of the needle or formed on a sleeve that fits onto the needle. The sleeve can be formed of a polymer and can be coupled to the needle by heating the sleeve so that the sleeve polymer flows into slit 314 to form a mechanical coupling of cooled polymer within the slit. Thus, the sleeve also acts as a barrier to prevent fluid from flowing through the slit. In various examples, sheath 318 can be removed from the length of the slit 314 that is bonded and sealed by the sleeve. The sleeve can be formed of various materials that reduce friction and provide radiopaque properties. In one example, the sleeve can be formed of a polymer mixture such as polyimide 12 and barium sulfate. In an alternative example, the surface of needle 302 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.

[0084] Figure 7A This is a side view of the distal end of a biopsy tool having a rigid portion 309A that is substantially similar to a rigid portion 309 and a flexible portion 310A including a slit pattern 350. In this example, the rigid portion 309A has a scalpel tip angled from one side of the hypotube. In this example, the slit pattern 350 is an interrupted spiral pattern. A continuous spiral pattern allows for deformable stretching or bending when the needle navigates sharp bends, but an interrupted spiral pattern provides bending flexibility while simultaneously limiting linear deformation and stretching. The angle of the spiral pattern can be varied to provide the desired flexibility. For example, the slit pattern may have approximately 2.5 incisions in each rotation, with 120° cut and 24° uncut, and a minute pitch of approximately 0.006 inches.

[0085] Figure 7B This is a side view of the distal end of a biopsy tool having a rigid portion 309B that is substantially similar to a rigid portion 309 and a flexible portion 310B including a slit pattern 360. In this example, the slit pattern 360 is a vertical slit pattern in which adjacent slits alternate with a 90° rotation. Each slit is approximately perpendicular to the longitudinal axis of the needle. The spacing of the slit patterns can be varied to provide desired flexibility.

[0086] Figure 8This is a side view of the distal end of biopsy tool 359, where the arcuate distal end 361 and distal point 362 are centered along the centerline A1 of the biopsy tool. The arcuate distal end 361 and distal point 362 are part of the rigid portion 363 of biopsy tool 359. Compared to a lancet tip that tends to arc away from the slanted edge when advanced, positioning the tip 362 along the needle centerline A1 allows the needle to advance along a straight trajectory through the tissue. The rigid portion 363 of the tool is coupled to a flexible portion 364, which may be the same as or similar to any of the flexible slit portions described above. Compared to lancet-type needles that may arc and drill into the sheath wall, displace a piece of the sheath into the patient, or be damaged and ineffective when piercing tissue, the biopsy tool 359 with a centered point reduces the likelihood of getting stuck on the inner wall of the sheath (especially when navigating sharp bends).

[0087] Figure 9 A handle assembly 306 is shown as an example of a tool control device 228. The handle assembly 306 includes a handle body 370, which is slidably coupled to a hollow shaft 372. The hollow shaft 372 extends through a needle stop 374 and is fixedly coupled to a hub 376. The hub 376 is slidably coupled to a connector assembly 378. Figure 10A As shown, the proximal end of needle 302 is coupled to tube 399, which may be a metal thiocyanate tube. Tube 399 extends through hollow shaft 372 and is secured within handle body 370. In one example, the tube is coupled to handle body 370 via plastic overmolding. The proximal end of sheath 304 is coupled to the distal end of hollow shaft 372. Catheter port 380 (e.g., port 233) is coupled to the distal end of connector assembly 378. Catheter port 380 may communicate with working channel 221 of catheter system 202.

[0088] The sliding movement of the hollow shaft 372 into and out of the handle body 370 can be limited by the needle stop 374. Multiple stop positions along the shaft 372 are marked using alphanumeric or graphic markings 392. For example... Figure 10BAs shown, spaced-apart ratchet teeth 384 are arranged along the outer bottom wall of shaft 372. A needle stop key 394 locks the needle stop 374 to shaft 372 via the ratchet teeth 384. By pressing the needle stop key 394, the key is released from the ratchet teeth 384, allowing the needle stop 374 to slide longitudinally along shaft 372 to another ratchet position. After repositioning, the needle stop key 394 can be released, and the needle stop 374 is locked at different longitudinal positions along shaft 372. The handle body 370 can then slide along shaft 372 until the distal end of the handle body abuts the proximal end of the needle stop. As the handle body 370 moves relative to shaft 372, the needle 302, fixed to the body 370, moves relative to the sheath 304, fixed to shaft 372. The mark 392, visible through the opening 395 in the needle stop 374, indicates the insertion depth of the needle 302 when the handle body 370 abuts against the needle stop 374.

[0089] The longitudinal position of connector assembly 378 relative to hub 376 is controlled by connector 396 (such as a thumb screw), which engages track 397 in the connector assembly. The distal end of connector assembly 378 includes quick-connect key 398, which engages and disengages conduit port 380. Therefore, the position of conduit port 380 relative to hub 376 can be adjusted by sliding connector assembly 378 and repositioning it relative to hub 376. The position of connector assembly 378 relative to hub can be locked by abutting the thumb screw against engaging track 397.

[0090] Figure 11 Method 400 for using medical tool 300 is shown. Method 400 in Figure 11 The illustrated steps are a set of operations or procedures 403-410. Not all illustrated procedures 403-410 will be performed in all embodiments of method 400. Furthermore, those not shown in... Figure 11 One or more processes explicitly shown may be included before, after, between, or as part of processes 403-410. In some embodiments, one or more of processes 403-410 are optional and may be omitted.

[0091] At procedure 403, needle 302, sheath 304, and core needle 320 can be advanced toward the target tissue area through the guiding system (e.g., catheter system 202 or bronchoscope). The sharp distal tip of needle 302 is covered by sheath 304 during advancement. At procedure 404, after needle 302, sheath 304, and core needle 320 have reached the distal end of the guiding system, further insertion force causes the sharp needle to continue advancing and pierce the wall as the needle and sheath assembly is advanced to impact the wall of the anatomical pathway. The blunt portion of the sheath does not pierce the wall, so the needle advances past the distal end of the sheath. Alternatively, sheath 304 can be withdrawn from its sharp distal tip before the needle and core needle are advanced. Core needle 320 helps maintain the alignment of the needle trajectory with the distal end of the guiding system. At procedure 406, core needle 320 is removed from needle 302. Optionally, a vacuum is applied to the needle to force tissue and fluid into needle 302. Although the needle includes a slit in its wall to allow for flexible bending, the slit is sealed by a sheath 318 that maintains a vacuum within the needle. At process 408, the needle 302 and sheath 304 are removed from the catheter, and the biopsy contents of the needle are removed. Optionally, processes 403-410 can be repeated to obtain multiple biopsy samples from the target tissue area, whether the catheters are in the same or different orientations.

[0092] Figure 12A A handle assembly 500 is shown as an example of a tool control device 228. Figure 12A The extended configuration of assembly 500 is shown, and Figure 12B The retracted configuration is shown. The handle assembly 500 includes a handle body 502 slidably coupled to a hollow shaft 504. The hollow shaft 504 extends through a needle stop 506 and is fixedly coupled to a hub 508. The hub 508 is slidably coupled to a connector assembly 510. The proximal end of a biopsy needle 302 is coupled to a tube (not shown), which may be a metal thiocyanate tube. The tube extends through the hollow shaft 504 and is fixed within the handle body 502. In one example, the tube is coupled to the handle body 502 via plastic overmolding. The proximal end of a sheath 304 is coupled to the distal end of the hollow shaft 504. A catheter may be coupled to the distal end of the connector assembly 510.

[0093] The sliding movement of the hollow shaft 504 into and out of the handle body 502 is limited by the needle stop 506. Multiple stop position markings 512 along the shaft 504 are indicated using alphanumeric or graphic markings. Spaced-apart ratchet teeth 514 are arranged along the outer bottom wall of the shaft 504. A needle stop key 516 locks the needle stop 506 to the shaft 504 by intersecting with the ratchet teeth 514. By pressing the needle stop key 516, the key is released from the ratchet teeth 514, allowing the needle stop 506 to slide longitudinally along the shaft 504 to another ratchet position. After repositioning, the needle stop key 516 can be released, and the needle stop 506 is locked in different longitudinal positions along the shaft 504. The handle body 502 can then be slid along the shaft 504 (where the shaft 504 slides into the body 502) until the distal end of the handle body abuts against the proximal end of the needle stop. As the handle body 502 moves relative to the shaft 504, the needle 302, fixed to the body 502, moves relative to the sheath 304, fixed to the shaft 504. A mark 512, visible through an opening 518 in the needle stop 506, indicates the insertion depth of the needle 302 when the handle body 502 abuts against the needle stop 506. In this embodiment, the opening 518 is located in the distal portion of the needle stop 506, between the needle stop key 516 and the hub 508.

[0094] The longitudinal position of connector assembly 510 relative to hub 508 is controlled by connector 520 (such as a thumbscrew) that engages track 522 in connector assembly. The distal end of connector assembly 510 includes connector key 524 that engages and releases conduit. (The following is a conduit description...) Figure 14 , Figure 15A Further descriptions of keys 516 and 524 are provided in -C. Therefore, the position of the conduit relative to the hub 508 can be adjusted by sliding the connector assembly 510 and repositioning it relative to the hub 508. The positioning of the connector assembly 510 relative to the hub can be locked by abutting the connector 520 against the engagement track 522.

[0095] In one exemplary embodiment, the handle assembly 500 can be used to perform a biopsy procedure as described below. (See, for example, catheters...) Figure 13The sheath 304 is coupled to connector assembly 510. As connector 520 unlocks from track 522, handle body 502, shaft 504, and hub 508 can be advanced distally relative to connector body and catheter as a unit to position the distal end of the sheath within the patient's anatomy. Sheath 304, biopsy needle 302, and core needle (e.g., core needle 320) are advanced as an assembly using handle body 502. After sheath 304 is positioned, connector 520 can be tightened by frictionally engaging track 522. Core needle can be removed by pulling core needle handle 526 from handle body 502. Biopsy can be performed by moving needle stop 506 along shaft 504 until the desired insertion distance is indicated at opening 518. To advance needle 302 from sheath 304, handle body 502 and needle 302 can be pushed distally against needle stop 506. Vacuum can be applied to collect tissue, and needle 302 can be removed.

[0096] like Figure 13 As shown, the handle assembly 500 is a type of medical instrument capable of being connected to the catheter housing 550 at a catheter port 552 (e.g., port 233). The catheter port 552 includes a recess 551 and a flange 553 for coupling a connector key 524 to the port 552. The catheter housing 550 is coupled to the proximal end of the catheter 554. The catheter 554 extends through an instrument adapter 556 and an instrument holder 558 (e.g., holder 244). The instrument holder 558 is movable along an insertion stage 560 (e.g., 246), which may be part of a remotely operated manipulator. Other types of medical instruments (including, for example, an image acquisition probe 562 or an ablation device) may be connected to the catheter port 552 to enter the catheter 554 (e.g., to be received within the lumen of the catheter 554). The image acquisition probe 562 may be communicatively coupled to the holder 558 via a cable 564 for transmitting power, image data, command signals, etc. The image acquisition probe 562 can also be coupled to a fluid source via a bracket 558, which can deliver clean fluid to the probe 562 via a pipe 566.

[0097] Figure 14 A cross-sectional view of a connector assembly 510 including connector key 524 and connector housing 570 is shown. Figure 15AConnector key 524 is shown in more detail. Connector key 524 includes a circular central member 572 coupled to a link portion 574. Arc-shaped arms 576 are coupled to the top of the link portion 574 such that the arms 576 are arcuate around the central member 572. The bottom end of each arm 576 includes an extension portion 577. The link portion 574 includes a finger-like gripping surface 578, which is arcuate to receive a downward force F from a user's fingers. The circular central member 572 defines a channel 580. A protrusion 582 extends from the central member 572 into the channel 580. Connector housing 570 includes a pair of guides 584 extending between the central member 572 and the arms 576 on opposite sides of the central member 572. The connector also includes a central passage 571. The guides include a stop member 585 that restricts movement of the extension portion 577 of the arm 576 in the direction opposite to the force F. Figure 15B As shown, when no force is applied to the connector key 524, the protrusion 582 extends into the central passage 571. When the port 552 extends into the central passage 571, the protrusion 582 protrudes into the recess 551 to lock the connector assembly 510 to the port 552. Figure 15C As shown, when a force F is applied to the connector key 524, the arm 576 elastically bends outward away from the central member 572 and the protrusion 582 recessed from the central passage 571. The movement of the arm 576 can be guided by the guide 584 and the stop member 585. Since the protrusion recessed from the central passage 571 also becomes removed from the recess 551, the port 552 is allowed to become decoupled from the connector assembly 510. When the force F is removed, the arm 576 is biased to move inward toward the central member 572. To prevent the key 524 from becoming removed from the housing 570, the stop member 585 restricts the movement of the extension portion 577 of the arm 576 in the direction opposite to the force F. In one example, the connector assembly 510 can be included on an adapter (not shown) configured to connect a medical instrument (e.g., a biopsy tool 300, an image acquisition probe, or an ablation device) to the catheter port 552 for access to the catheter 554.

[0098] Figure 16 A cylindrical section 600 of a biopsy needle is shown, which has an irregular spiral or helical interrupted slit pattern 602 in the needle wall 603. To better depict this slit pattern, the cylindrical section 600 can be longitudinally sectioned along an axis 604 that extends along the wall 603. Figure 17 The cylindrical wall section 610 of the biopsy needle is shown, as follows: Figure 16 As shown, it is segmented or longitudinally "cut" to illustrate slit pattern 612. (See diagram.) Figure 17As shown, the wall segment 610 is "unfolded" into a planar view to illustrate the slit pattern 612. The slit pattern 612 has at least one physical diameter that gradually changes as the pattern progresses from the proximal end to the distal end of the wall segment. This changing physical diameter causes the flexibility of the cylindrical segment to change from the proximal end to the distal end of the wall segment. For example, as... Figure 19 As shown in the enlarged view of wall segment 614, the physical parameter can be the slit length. To reduce flexibility from the proximal end to the distal end of wall segment 614, slit S1 has a longer length than slit S2, slit S2 has a longer length than slit S3, and slit S3 has a longer length than slit S4. The longer slit at the proximal end provides greater flexibility, while the shorter slit at the distal end provides relatively greater stiffness. As another example, such as Figure 19 As shown in the enlarged view of wall segment 614, the physical parameter can be the bridge length of the bridging wall material between the ends of the successive slits. To reduce flexibility from the proximal end to the distal end of wall segment 614, bridge B1 has a shorter length than bridge B2, bridge B2 has a shorter length than bridge B3, and bridge B3 has a shorter length than bridge B4. The shorter bridge length at the proximal end provides greater flexibility, while the longer bridge length at the distal end provides relatively greater stiffness. As another example, such as Figure 19 As shown in the enlarged view of the wall segment 614, the physical parameter can be the angle of the slit relative to the longitudinal axis. To reduce flexibility from the proximal end to the distal end of the wall segment 614, slit S1 cuts at a larger angle (e.g., 80°) than slit S2 (e.g., 79°), and the angle of slit S2 (e.g., 79°) is larger than the angle of slit S3 (e.g., 78°). The larger slit angle at the proximal end provides greater flexibility, while the smaller slit angle at the distal end provides relatively greater stiffness. More than one physical parameter can be varied in the needle segment to provide the necessary flexibility gradient. Other physical parameters that can be gradually changed to vary the segment's flexibility include the pitch of the slit pattern, the width of the slit, and the angle of the helical pattern. To provide a smooth helical curve, the slits in the slit pattern can be cut along a gradually changing curve. Figure 18 A wall segment 620 with an arcuate slit pattern 622 is shown, wherein each cycle of the spiral rotation gradually increases from the proximal end of the segment to the distal end of the segment.

[0099] Figure 20a shows a side view of a rigid distal portion 650 (e.g., rigid portion 309) of a biopsy tool. The rigid distal portion 650 includes a distal cutting section 652 and a shaft portion 654. The shaft portion 654 has a circular cross-section, and the cutting section 652 has an elliptical or oval cross-section created by flattened, angled walls 656. The cutting section 652 includes a cutting surface 658. The circular volume of portion 654 provides a large volume cavity for storing a large amount of tissue. The oval or elliptical cross-section of the cutting section 652 retains a sharp tip for piercing tissue while minimizing damage to the inner wall of the sheath (e.g., sheath 304) through which the distal portion 650 can pass.

[0100] Figure 21 and Figure 22 A needle sheath 670 (e.g., sheath 304) is shown, comprising an elongated tubular member 674 and a protective member 672. The elongated tubular member 674 includes a wall defining a channel 676. The protective member 672 includes a head portion 678, a tapered portion 680, and a tubular body portion 682. The body portion 682 is sized to fit within the channel 676 and can be secured by teeth on the body portion 682 or the channel 676, interlocking teeth on both the body portion and the channel, friction, and / or adhesive. The tapered portion 680 may also fit within the channel 676. The head portion 678 may extend distally from the distal tip of the tubular member 674. The head portion may be tapered and may have rounded edges to prevent tissue damage. The tubular member 674 may be formed of a flexible material (such as Pebax) that can be mixed with a lubricating material to allow the sheath to slide easily within the catheter. The protective member 672 may be formed of a more rigid material than the tubular member 674. Suitable materials may include metals or hardened plastics that resist damage from the tip of the biopsy needle. The tubular member or protective member may include radiopaque markings to guide the movement of the biopsy needle within the patient's anatomy.

[0101] The sheath 670 may be shaped with a distal tilt to allow for greater flexibility and navigation at the distal end of the sheath 670. In one embodiment, the tubular member 674 may have a proximal wall thickness T1, an intermediate wall thickness T2, and a distal wall thickness T3. The protective member 672 may have a maximum wall thickness T4. Wall thicknesses T1, T3, and T4 are greater than wall thickness T2 to provide a narrowed or hourglass shape for the sheath. In an alternative embodiment, wall thicknesses T1 and T4 are greater than wall thickness T2, and wall thickness T3 may be greater than, equal to, or less than wall thickness T2.

[0102] One or more elements in embodiments of the present invention (e.g., processing of signals received from one and / or more input control devices of the flexible conduit) can be implemented in software to execute on a processor of a computer system (such as control system 112). When implemented in software, the elements of embodiments of the present invention are essentially code segments for performing necessary tasks. Programs or code segments can be stored in non-transitory machine-readable storage media, including any medium capable of storing information, including optical, semiconductor, and magnetic media. Examples of machine-readable storage media include electronic circuits; semiconductor devices, semiconductor memory devices, read-only memory (ROM), flash memory, erasable programmable read-only memory (EPROM); floppy disks, CD-ROMs, optical disks, hard disks, or other storage devices. Code segments can be downloaded via computer networks (such as the Internet, intranets, etc.). As described herein, operations such as accessing, detecting, initializing, registering, displaying, receiving, generating, determining, moving data points, segmenting, matching, etc., can be performed at least in part by control system 112 or its processor.

[0103] Note that the presentation process and display may not be inherently associated with any particular computer or other device. The desired architecture of various such systems will appear as elements in the claims. Furthermore, embodiments of the invention are not described with reference to any particular programming language. It should be understood that various programming languages ​​can be used to implement the teachings of the invention described herein.

[0104] While specific exemplary embodiments of the invention have been described and shown in the accompanying drawings, it should be understood that these embodiments are merely illustrative of the broad invention and not limiting, and that embodiments of the invention are not limited to the specific structures and arrangements shown and described, as various other modifications will be apparent to those skilled in the art.

Claims

1. A medical device system comprising: Needles, which include: The main body extends from the distal end of the needle to the proximal end of the needle; The inner surface of the needle forms a channel extending through at least a portion of the body portion to an opening in the distal end, wherein the channel and the opening are configured for collecting tissue biopsies. as well as A surface feature portion, located proximal to the distal end of the needle, includes a plurality of slits, the plurality of slits including one or more first slits and one or more second slits; An elongated shaft coupled to the proximal end of the needle; as well as The sheath includes an internal channel, wherein: In the first configuration, the distal end of the needle is positioned within the internal channel, and In the second configuration, the distal end of the needle extends beyond the distal end of the sheath. The elongated shaft comprises a polymer tube, and the proximal portion of the elongated shaft extends around one or more of the second slits in the plurality of slits.

2. The medical device system of claim 1, wherein the needle further includes a sharp tip at the distal end of the needle.

3. The medical device system of claim 2, wherein the sharp tip is shaped into an arc, and wherein the distal point of the sharp tip is aligned along the centerline of the needle.

4. The medical device system of claim 1, wherein in the second configuration, the needle extends approximately 3 cm beyond the distal end of the sheath.

5. The medical device system of claim 1, wherein the outer diameter of the needle is approximately 1 mm.

6. The medical device system of claim 1, wherein each of the plurality of slits, the laser-cut slit, extends through the wall of the needle.

7. The medical device system of claim 6, wherein the needle further includes a sharp tip at the distal end of the needle.

8. The medical device system of claim 6, wherein in the second configuration, the needle extends approximately 3 cm beyond the distal end of the sheath.

9. The medical device system of claim 1, wherein the channel and the opening are configured to acquire tissue biopsy when the medical device system is in the second configuration.

10. The medical device system of claim 1, wherein the needle is coupled to a handle, the handle being movable between a first handle configuration and a second handle configuration.

11. The medical device system of claim 10, wherein when the handle is in the first handle configuration, the medical device system is in the first configuration, and when the handle is in the second handle configuration, the medical device system is in the second configuration.

12. The medical device system of claim 1, wherein the distal section of the needle is made of stainless steel.

13. The medical device system of claim 1, wherein the sheath comprises a polymer.

14. The medical device system of claim 1, wherein the sheath comprises a radiation-proof material at the distal portion of the sheath.

15. The medical device system of claim 1, wherein the plurality of slits are arranged in a spiral pattern.

16. The medical device system of claim 1, further comprising a core needle formed of an elastic material, the core needle being sized to extend through the channel of the needle.

17. The medical device system of claim 16, wherein when the core needle extends through the channel and through the surface feature portion, the core needle is configured to straighten the surface feature portion.

18. The medical device system of claim 1, wherein the sheath further comprises a rigid protective member positioned at the distal end of the sheath, the rigid protective member surrounding the passage of the sheath.

19. The medical device system of claim 18, wherein at least a portion of the rigid protective member is radiation-proof.

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