Robotic-assisted endoluminal surgical system and related methods

Abstract

An endoluminal robotic system provides a surgeon with the ability to robotically drive an endoscopic device to a desired anatomical location within a patient's body without awkward motion and position, while also enjoying improved image quality from a digital camera mounted on the endoscopic device.

Description

[0001] This application is a divisional application of the invention patent application with international application number PCT / US2014 / 062284, international application date October 24, 2014, and Chinese application number 201480070794.7.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Patent Application No. 61 / 895,312 filed on October 24, 2013 (Attorney Docket No. 41663-711.101); U.S. Provisional Patent Application No. 61 / 895,315 filed on October 24, 2013 (Attorney Docket No. 41663-712.101); U.S. Provisional Patent Application No. 61 / 895,602 filed on October 25, 2013 (Attorney Docket No. 41663-713.101); The present invention claims priority to U.S. Provisional Patent Application No. 61 / 940,180 filed on February 14, 2012 (Attorney Docket No. 41663-714.101); U.S. Provisional Patent Application No. 62 / 019,816 filed on July 1, 2014 (Attorney Docket No. 41663-713.102); and U.S. Provisional Patent Application No. 62 / 037,520 filed on August 14, 2014 (Attorney Docket No. 41663-715.101), the entire contents of which are incorporated herein by reference. Background Art

[0004] 1. Technical Field The field of the present application relates to medical devices. More specifically, the field of the present invention relates to systems and tools for robotic-assisted endoluminal surgery.

[0005] 2. Description of Related Technology Endoscopy is a widely used minimally invasive technique for imaging and delivering therapeutic agents to anatomical locations within the human body. Typically, a flexible endoscope is used to deliver tools to a surgical site inside the body—for example, through a small incision or natural orifice in the body (nose, anus, vagina, urethra, throat, etc.)—where a procedure is performed. An endoscope may have imaging, illumination, and steering capabilities at the distal end of a flexible shaft that enables navigation of nonlinear lumens or pathways.

[0006] To assist navigation, endoscopes typically have devices that articulate small distal curved segments. Today's endoscopic devices are typically handheld devices with numerous levers, dials, and buttons for various functionalities, but offer limited performance in terms of articulation. For control, the physician controls the position and progression of the endoscope by manipulating a leaver or dial to coordinate the twisting of the endoscope's axis. These techniques require physicians to twist their hands and arms when using the device to deliver the endoscope to the desired position. The resulting arm movements and positions are awkward for physicians; maintaining those positions can also be laborious. Therefore, manual actuation of the curved segments is typically limited by low actuation forces and poor ergonomics.

[0007] Today's endoscopic devices have additional challenges. Today's endoscopes often require support personnel to deliver, operate, and remove surgical, diagnostic, or therapeutic equipment from the endoscope while the physician maintains the desired position. Today's endoscopes utilize pull wires that create tissue with curved alignment and muscling. Some procedures require fluoroscopy or segmented CT scans to assist in navigation to the desired location, particularly for small lumen navigation.

[0008] Therefore, it would be beneficial to have systems and tools for endoluminal procedures that provide improved ergonomics, usability, and navigation. Summary of the invention

[0009] In one aspect, the present invention provides a system for performing a robotic-assisted surgical procedure, comprising: a first robotic arm having a proximal segment and a distal segment, a first mechanism converter interface coupled to the distal segment of the first robotic arm, a first instrument manipulator coupled to the first mechanism converter interface, the first instrument manipulator being configured to robotically drive a tool for performing a surgical procedure at a surgical site within a patient's body, and wherein the first instrument manipulator includes a drive unit.

[0010] In a related apparatus, the drive unit includes a motor. In some embodiments, the first instrument manipulator is configured to releasably disengage from the mechanism changer interface and the first robotic arm.

[0011] In a related apparatus, the first mechanism transducer interface is configured to interface with a plurality of instrument manipulators. In some embodiments, the first mechanism transducer interface is configured to transmit electrical signals from the first robotic arm to the first instrument manipulator.

[0012] In a related device, the present invention also includes an endoscopic tool coupled to a first instrument manipulator, the endoscopic tool comprising a main elongated body. In some embodiments, an electromagnetic tracker is coupled to a distal end segment of the main elongated body. In some embodiments, an accelerometer is coupled to the distal end segment of the main elongated body.

[0013] In a related device, the main elongated body includes a working channel longitudinally aligned with a neutral axis of the main elongated body, and a pull lumen aligned at an angle in a spiral around the working channel. In some embodiments, the angle of the spiral varies along the length of the main elongated body. In some embodiments, the pull lumen includes an elongated tendon fixedly coupled to a distal segment of the main elongated body and responsive to a first instrument manipulator.

[0014] In a related device, the endoscopic tool also includes a secondary slender body longitudinally aligned around the main slender body, wherein the main slender body includes a proximal segment and a distal segment, and wherein the digital camera is connected to the distal end. In some embodiments, the system also includes a second robotic arm connected to a second instrument manipulator through a second mechanism converter interface, wherein the second instrument manipulator is connected to the endoscopic tool, and the first instrument manipulator and the second instrument manipulator are configured to align to form a virtual track for operating the endoscopic tool. In some embodiments, the first instrument manipulator is operable to control the secondary slender body, and the second instrument manipulator is operable to control the main slender body. In some embodiments, the first robotic arm and the second robotic arm are connected to a movable system cart. In some embodiments, the first robotic arm and the second robotic arm are connected to an operating table configured to hold a patient. In some embodiments, the system cart is configured to send sensor data to a command console and receive command signals from the command console. In some embodiments, the command console is separate from the system cart. In some embodiments, the command console includes a display module and a control module for controlling the endoscopic tool. In some embodiments, the control module is a joystick controller. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The invention will now be described by way of example with reference to the accompanying schematic drawings, in which:

[0016] Figure 1 A robotic endoscope system according to an embodiment of the present invention is illustrated;

[0017] Figure 2A A robotic surgical system according to an embodiment of the present invention is illustrated;

[0018] Figure 2B A top view of a system 200 is illustrated in which an anesthesia cart 201 is provided toward a patient's head;

[0019] Figure 2C Shows Figure 2A A view of system 200;

[0020] Figure 2D and Figure 2E An alternative arrangement of arms 202 and 204 illustrating the versatility of a robotic surgical system according to an embodiment of the present invention is illustrated;

[0021] Figure 3A illustrates a top view of a system having multiple virtual rails according to an embodiment of the present invention;

[0022] Figure 3B Illustration of a robot with attached robot arm, associated tool base and tool Figure 3A the use of robotic surgical systems;

[0023] Figure 4 IDM and tool-interchangeable robotic surgical system according to an embodiment of the present invention are illustrated;

[0024] Figure 5A An implementation of a mechanism converter interface coupled to a robot arm in a robot system according to an embodiment of the present invention is illustrated;

[0025] Figure 5B Pictured Figure 5A An alternative view of a male mechanism converter interface 502;

[0026] Figure 5C Illustration of a manipulator connected to an instrument for use with Figure 5A and Figure 5B The male mechanism converter interface 502 is connected to the complementary female mechanism converter interface;

[0027] Figure 5D Pictured Figure 5C An alternative view of a concave mechanism converter interface 508;

[0028] Figure 6 A robotic surgical system using a single-port laparoscopic instrument connected through an instrument interface on a single robotic arm directed toward a patient's abdomen is illustrated in accordance with an embodiment of the present invention;

[0029] Figure 7 A robotic surgical system having two robotic subsystems, each having a pair of arms, according to an embodiment of the present invention is illustrated;

[0030] Fig. 8AA robotic surgical system having a subsystem with a single robotic arm is illustrated, wherein a microscope tool is connected to the robotic arm via an instrument interface, according to an embodiment of the present invention;

[0031] Figure 8B The present invention is an embodiment of the present invention. Fig. 8A The subsystem 801 may be combined with another system to perform a robotic surgical system for microsurgery;

[0032] Fig. 9A illustrates a portion of a robotic medical system including a manipulator according to an embodiment of the present invention;

[0033] Fig. 9B Pictured Fig. 9A Alternative views of the robotic medical system disclosed in;

[0034] Fig.10 FIG. 1 is a diagram showing a tension sensor device according to an embodiment of the present invention. Fig. 9A , Fig. 9B Alternative views of the independent drive mechanism;

[0035] Fig.11A Pictured from another angle Fig. 9A , Fig. 9B and Fig.10 A cross-sectional view of an independent driving mechanism;

[0036] Fig. 11B illustrates a cross-sectional view of the separate drive mechanism discussed previously in conjunction with the endoscopic tool according to an embodiment of the present invention;

[0037] Fig.12 An alternative view of the previously discussed independent drive mechanism with a pull wire from an endoscopic tool is illustrated in accordance with an embodiment of the present invention.

[0038] Fig.13 illustrates a conceptual diagram showing how horizontal forces may be measured by strain gauges oriented perpendicular to the forces, according to an embodiment of the present invention;

[0039] Fig.14 According to an embodiment of the present invention, it can be combined Figure 1 An illustration of an endoscopic tool used by the robotic system 100;

[0040] Fig.15A , Fig. 15B , Fig. 15C , Fig.16A and Fig. 16B Generally illustrating various aspects of a robotically driven endoscopic tool according to an embodiment of the present invention;

[0041] FIG. 17A to FIG. 17D illustrates how prior art flexible instruments exhibit undesirable "muscle development" phenomena when tendons are stretched;

[0042] FIG. 17E to FIG. 17H illustrates how prior art flexible instruments suffer from curve alignment phenomena during use in non-linear pathways;

[0043] Fig.17I and Fig.17J illustrates how the muscle development and curve alignment phenomena are substantially addressed by providing a helical segment according to an embodiment of the present invention;

[0044] Fig.18 The structure of a flexible endoscope tool having an axially rigid tube in a lumen according to an embodiment of the present invention is illustrated;

[0045] Fig.19 The structure of the spiral pattern in the lumen of the flexible endoscope tool according to the embodiment of the present invention is illustrated;

[0046] Fig. 20A An endoscopic tool from a robotic endoluminal system is illustrated in accordance with an embodiment of the present invention;

[0047] Fig. 20B Pictured Fig. 20A Alternative views of the endoscope tool 2000;

[0048] Fig.21 illustrates a distal end of an endoscopic tool according to an embodiment of the present invention;

[0049] Fig. 22 A flow chart illustrating a method of constructing an endoscopic device having a spiral lumen according to an embodiment of the present invention is illustrated;

[0050] Fig.23 A system for manufacturing a flexible endoscope according to an embodiment of the present invention is illustrated;

[0051] Fig.24 A special nose cone for manufacturing an endoscopic device with a spiral pulling lumen according to an embodiment of the present invention is illustrated;

[0052] Fig.25A and Fig.25B The relationship between centerline coordinates, diameter measurements, and anatomical space is illustrated;

[0053] Fig.26 illustrates a computer generated three-dimensional model representing an anatomical space according to an embodiment of the present invention;

[0054] Fig. 27A robotic intracavitary system utilizing an electromagnetic tracker in combination with an electromagnetic field generator according to an embodiment of the present invention is illustrated;

[0055] Fig.28 illustrates a flow chart of steps for registration according to an embodiment of the present invention;

[0056] Fig.29A illustrates a distal end of an endoscopic tool within an anatomical lumen according to an embodiment of the present invention;

[0057] Fig.29B FIG. 1 is a diagram of a method for use at a surgical site within an anatomical lumen according to an embodiment of the present invention. Fig.29A Endoscopic tools;

[0058] Fig.29C FIG. 1 is a diagram of a method for use at a surgical site within an anatomical lumen according to an embodiment of the present invention. Fig.29B Endoscopic tools;

[0059] Fig. 30A An endoscopic tool coupled to a distal flexible section within an anatomical lumen is illustrated in accordance with an embodiment of the present invention;

[0060] Fig. 30B FIG. 1 illustrates a surgical device having a forceps tool used at a surgical site within an anatomical lumen according to an embodiment of the present invention. Fig. 30A Endoscopic tools;

[0061] Fig. 30C FIG. 1 illustrates a laser device used at a surgical site within an anatomical lumen according to an embodiment of the present invention. Fig. 30A Endoscopic tools; and

[0062] Fig.31 A command console for a robotic endoluminal system is illustrated in accordance with an embodiment of the present invention. DETAILED DESCRIPTION

[0063] Although certain preferred embodiments and examples are disclosed below, the subject matter of the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, modifications thereof, and equivalents thereof. Therefore, the scope of the claims appended hereto is not limited to any of the specific embodiments described below. For example, in any method or process disclosed herein, the actions or operations of the method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Various operations may be described in sequence as multiple discrete operations in a manner that may be helpful in understanding certain embodiments; however, the order of description should not be interpreted as implying that the operations are sequence-dependent. Additionally, the structures, systems, and / or devices described herein may be embodied as integrated components or separate components.

[0064] For the purpose of comparing various embodiments, certain aspects and advantages of these embodiments are described. It is not necessary to achieve all of these aspects or advantages by any particular embodiment. Thus, for example, various embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may be taught or suggested herein.

[0065] 1. Overview

[0066] An endoluminal surgical robotic system provides a surgeon with the ability to sit in an ergonomic position and control a robotic endoscopic tool to a desired anatomical location within a patient's body without the need for awkward arm movements and positions.

[0067] The robotic endoscopic tool has the ability to easily navigate the lumen within the human body by providing multiple degrees of freedom at at least two points along its length. The tool's control points provide the surgeon with significantly more instinctive control of the device as it navigates a cranked path within the human body. The tool's tip is also able to articulate from 0 degrees to 90 degrees for all 360 degrees of roll angle.

[0068] The surgical robotic system can combine both external sensor-based and internal vision-based navigation techniques to assist the physician in guiding to the desired anatomical location within the patient. The navigation information can be transmitted in a two-dimensional display device or a three-dimensional display device.

[0069] 2. System components

[0070] Figure 1 is a robotic endoscope system according to an embodiment of the present invention. Figure 1 As shown, the robotic system 100 may include a system cart 101 having at least one robotic arm, such as arm 102. The system cart 101 may communicate with a remotely located command console (not shown). In practice, the system cart 101 may be arranged to provide access to the patient while the physician may control the system 100 from the comfort of the command console. In some embodiments, the system cart 100 may be integrated into an operating table or bed for stability and access to the patient.

[0071] Within the system 100, an arm 102 may be fixedly coupled to a system cart 101 that contains a variety of support systems (including, in some embodiments, control electronics, power supplies, and light sources). The arm 102 may be formed of a plurality of links 110 and joints 111 to enable access to the surgical field of a patient. The system cart 103 may contain a power supply 112, pneumatic pressure 113, and control and sensor electronics 114 (including components such as a central processing unit, data bus, control circuits, and memory) and associated actuators or motors that may drive an arm such as the arm 102. Power may be transmitted from the system cart 101 to the arm 102 using a variety of devices known to those skilled in the art (such as wires, gear heads, air chambers). The electronics 114 in the system cart 101 may also process and transmit control signals communicated from a command console.

[0072] The system cart 101 may also be mobile, as shown by wheels 115. In some embodiments, the system cart can be pushed to a desired location near the patient. The system cart 101 may be located at different locations in the operating room to accommodate space requirements and facilitate proper placement and movement of modules and instruments relative to the patient. This capability enables the arms to be positioned where they do not interfere with the patient, physician, anesthesiologist, or any supporting surgical equipment required for the selected procedure. During the procedure, the arms with the instruments work in concert via user control through a separate control device, which may include a command console with a tactile device, a joystick, or a custom pendant.

[0073] 3. Robotic Arm

[0074] The proximal end of the arm 102 may be fixedly mounted or coupled to the cart 101. The robotic arm 102 includes a plurality of links 110 connected by at least one joint, such as joint 111, for each arm. If the robotic arm 102 is robotic, the joint 111 may include one or more actuators to affect motion in at least one degree of freedom. The arm 102 as a whole preferably has more than three degrees of freedom. Each arm may also transmit power and control signals from the system cart 101 to instruments at the end thereof through a combination of wires and circuits.

[0075] In some embodiments, the arm can be fixedly coupled to an operating table with a patient. In some embodiments, the arm can be coupled to the base of the operating table and reach around to approach the patient.

[0076] In some embodiments, the robotic arm may not be robotically driven. In those embodiments, the robotic arm includes a linkage and a set joint that uses a combination of brakes and counterbalances to maintain the position of the arm in place. In some embodiments, the counterbalance may be constructed of gas springs or coil springs. The brakes (such as fail-safe brakes) may be mechanical or electromechanical. In some embodiments, the arm may be a gravity-assisted passive support arm.

[0077] At the distal end, each arm may be coupled to a movable instrumentation manipulator (IDM) such as 117 via a mechanism converter interface (MCI) such as 116. In a preferred embodiment, the MCI 116 may include connectors for transferring pneumatic pressure, electrical power, electrical signals, and optical signals from the arm to the IDM 117. In some embodiments, the MCI 116 may be as simple as a set screw or base plate connection.

[0078] IDM 117 may have a variety of means for manipulating surgical instruments including direct drive, harmonic drive, gear drive, belt and pulley, or magnetic drive. It will be appreciated by those skilled in the art that a variety of methods may be used to control actuators on instrumentation.

[0079] Within the robotic system, an MCI, such as 116, may be interchangeable with a variety of process-specific IDMs, such as 117. In this embodiment, the interchangeability of the IDMs allows the robotic system 100 to perform different processes.

[0080] Preferred embodiments may use a robotic arm with a wrist at the distal end that senses joint level torque, such as Kuka AG's LBR5. These embodiments have a robotic arm with seven joints, while providing redundant joints to avoid potential arm collisions with patients, other robotic arms, operating tables, medical personnel, or equipment approaching the surgical field, while maintaining the wrist in the same posture so as not to interrupt the ongoing procedure. It will be understood by those skilled in the art that a robotic arm with at least three degrees of freedom (and more preferably six or more degrees of freedom) will fall within the inventive concepts described herein, and it will also be understood that more than one arm may be provided with an additional module, wherein each arm may be mounted on one or more carts, either collectively or individually.

[0081] 4. Virtual Track Configuration

[0082] The arm 102 in the system 100 can be arranged in a variety of postures for a variety of procedures. For example, in conjunction with another robotic system, the arm 102 of the system 100 can be arranged to align its IDM to form a "virtual track" that facilitates insertion and manipulation of the endoscopic tool 118. For other procedures, the arm can be arranged differently. Therefore, the use of the arm in the system 100 provides flexibility not found in robotic systems whose designs are directly related to specific medical procedures. The arm of the system 100 provides a potentially larger stroke and load.

[0083] Figure 2A A robotic surgical system 200 is illustrated in accordance with an embodiment of the present invention. The system 200 has a first arm 202 and a second arm 204 that hold endoscope tool bases 206 and 208, respectively. The tool base 206 has a controllable endoscope sheath 210 operably connected thereto. The tool base 208 has a flexible endoscope leader 212 operably connected thereto.

[0084] The arms 202 and 204 are aligned with the tool bases 206 and 208 so that the proximal end 216 of the sheath 210 is distal from the proximal end 222 of the guide 212 and so that the guide 212 is maintained axially aligned with the sheath 210 at an approximate angle of 180 degrees between the two arms, thereby creating a "virtual track" in which the track is generally straight, or 180 degrees. As will be described later, the virtual track can have an angle between 90 degrees and 180 degrees. In one embodiment, the sheath 210, with the guide 212 slidably disposed therein, is robotically inserted through a tracheal tube (not shown) in, for example, the mouth of the patient 211 and into the patient 211, and ultimately into the patient's bronchial system, while continuing to maintain the virtual track during insertion and navigation. The arms can be positioned at the console 203 ( Figure 2B ) at the sheath 210 and the endoscope 212 are axially moved relative to each other and into or out of the patient 211 according to the control of a physician (not shown).

[0085] Navigation is achieved, for example, by advancing the sheath 210 into the patient 211 with the guide 212, and then the guide 212 can be advanced beyond the distal end 213 of the sheath, and then the sheath 210 can be carried even with the guide 212 until the desired destination is reached. Other modes of navigation can be used, such as but not limited to using a guide wire through the working channel of the guide 212. The physician can use any number of visual guidance modalities or their combination to help navigate and perform medical procedures, such as fluoroscopy, video, CT, MR, etc. The distal end 220 of the guide 212 is then navigated to the surgical site and the tool is deployed through the longitudinally aligned working channel in the guide 212 to perform the desired process. The virtual track can be maintained during the navigation process and any subsequent surgical process. As will be appreciated by those skilled in the art, any number of alternative processes that may require tools or do not require tools at all can be performed using a flexible endoscope that slides through the sheath.

[0086] Figure 2B A top view of a system 200 is shown in which an anesthesia cart 201 is provided toward the patient's head. Additionally, a control sheath 210, an endoscope guide 212 and associated arms 202 and 204 and tool bases 206 and 208 (see FIG. Figure 2A ) provides a console 203 having a user interface.

[0087] Figure 2C Shows Figure 2A 200. Tool modules 206 and 208 with associated sheaths 210 and guides 212 are attached to arms 202 and 204 and arranged in a 180 degree virtual track. The arms are shown on a single cart, which provides additional compactness and maneuverability. As will be discussed later, tool bases 206 and 208 have pulley systems or other actuation systems for tensioning ribs in the sheaths 210 and guides 212 to manipulate their respective distal ends. Tool bases 206 and 208 can provide other desired utilities for the sheaths and endoscopes, such as pneumatic pressure, electricity, data communications (e.g., for vision), mechanical actuation (e.g., motor drive shafts), etc. These utilities can be provided to the tool bases through the arms from a single source or a combination of both.

[0088] Figure 2D and Figure 2E An alternative arrangement of arms 202 and 204 illustrating the versatility of a robotic surgical system is illustrated in accordance with an embodiment of the present invention. Figure 2D2, arms 202 and 204 may be extended to position the instrument (including sheath 210 and guide 212) to enter the oral cavity of patient 211 at an angle of 75 degrees from horizontal, while still maintaining a 180 degree virtual track. This may be done during the procedure to accommodate space requirements in the room, if desired. An angle of 75 degrees is selected for exemplary purposes and not limitation.

[0089] Figure 2E An alternative arrangement of arms 202 and 204 is shown in which tool bases 206 and 208 are aligned to create a virtual track at an angle of 90 degrees according to an embodiment of the present invention. In this embodiment, the instrument (including sheath 210 and guide 212) enters the oral cavity of patient 213 at an angle of 75 degrees to the horizontal plane. The tool bases 206 and 208 are aligned so that the guide 212 bends 90 degrees at the tool base 206 before entering the oral cavity of patient 213. To facilitate the bending of the guide 212, a rigid or semi-rigid structure (such as a tube) can be used to ensure smooth extension and retraction of the guide 212 within the sheath 210. The extension and retraction of the guide 212 within the sheath 210 can be controlled by moving the tool base 208 closer to or away from the tool base 206 along a linear path traced by the guide 212. The extension and retraction of the sheath 210 can be controlled by moving the tool base 206 closer to or away from the patient 213 along a linear path traced by the sheath 210. To avoid unintended extension and retraction of the guide 212 while extending or retracting the sheath 210 , the tool base 208 may also be moved along a linear path parallel to the sheath 210 .

[0090] The virtual rail is used to drive both rigid and flexible instruments, and particularly instruments where telescopic requirements are present. The use of the virtual rail is not limited to a single rail, but may consist of multiple virtual rails where the arms coordinate actions to maintain each virtual rail while performing one or more processes.

[0091] Figure 3A FIG. 1 illustrates a top view of a system with multiple virtual rails according to an embodiment of the present invention. Figure 3A , robotic arms 302, 304, and 306 hold tool bases 308, 310, and 312, respectively. Tool bases 308 and 310 can be operably coupled to flexible tools 314 and 316. Tools 314 and 316 can be flexible endoscopic instruments controlled by telerobotics. Tool base 312 can be operably coupled to a dual lumen sheath 318, wherein each lumen receives tools 314 and 316. Arms 302 and 304 can each maintain a virtual track with robotic arm 306, and the motion of all three arms can be coordinated to maintain the virtual track and move tools 314, 316, and sheath 318 relative to each other and the patient.

[0092] Figure 3B The diagram shows a robot arm 320 with an associated tool base 322 and tool 324. Figure 3A In this embodiment, the sheath 325 may have three lumens. Alternatively, the sheath 325 may include more than one sheath for providing access tools 314, 316, and 324. As will be appreciated, the ability to increase or decrease the number of arms with associated modules and instruments allows for a large number and flexibility of surgical configurations, which in turn allows for rethinking of expensive arms and using multiple relatively inexpensive modules to achieve great versatility at a reduced cost.

[0093] Therefore, in order to generate a virtual track, multiple arms and / or platforms can be utilized. Each platform / arm must be registered to other platforms / arms, which can be achieved by multiple modalities (including visual, laser, mechanical, magnetic or rigid attachment). In one embodiment, the registration can be achieved by a multi-arm device with a single base using mechanical registration. In mechanical registration, an embodiment can register arm / platform placement, position and orientation based on their position, orientation and placement relative to a single base. In another embodiment, the registration can be achieved by a system with multiple bases using a separate base registration and a "handshake" between multiple robotic arms. In an embodiment with multiple bases, the registration can be achieved by touching the arms together from different bases and calculating the position, orientation and placement based on (i) physical contact and (ii) the relative positions of those bases. In some embodiments, the registration target can be used to match the position and orientation of the arms relative to each other. Through such registration, the arms and instrument drive mechanisms can be calculated in space relative to each other.

[0094] 5. Mechanism converter interface

[0095] Return to Figure 1 , the robotic surgical system 100 can be configured in a manner to provide multiple surgical system configurations, such as by changing the IDM 117 and tools 118 (also referred to as end effectors). The system can include one or more mobile robotic platforms at different locations in the operating room or at convenient nearby locations. Each platform can provide some or all of the power, pneumatic pressure, illumination source, data communication cables, and control electronics for the robotic arms connected to the platform, and modules can also be obtained from these utilities. Alternatively, the system 100 can have multiple arms 102 mounted on one or more mobile carts 101, or the arms can be mounted to the floor to provide multiple surgical configurations.

[0096] In addition to multiple arms and platforms, some embodiments are designed to easily swap between multiple modules or end effector mechanisms. Various surgical procedures or steps within a procedure may require the use of different modules and associated instrumentation setups, for example, swapping between different sized sheath and endoscope combinations. Interchangeability allows the system to be reconfigured for different clinical procedures or to adjust surgical approaches.

[0097] Figure 4 A robotic surgical system with interchangeable IDMs and tools according to an embodiment of the present invention is illustrated. A surgical system 400 has a robotic arm 401 to which an IDM 402 and a tool 403 are attached. IDMs 405 and 406 and associated tools 407 and 408 attached to a system cart 404 can be exchanged onto the robotic arm 401 or picked up by a different robotic arm (not shown) to be used in combination with another IDM and tool alone. Each IDM can be a specialized electromechanical system that can be used to drive various types of instruments and tools for a specified process. In order to drive the instrument, each IDM can include an independent drive system that can include a motor. They can contain sensors (e.g., RFID) or memory chips that record their calibration and application-related information. After the new mechanism is connected to the robotic arm, a system calibration check may be required. In some embodiments, the IDM can control an endoscope sheath or a flexible endoscope guide.

[0098] exist Figure 4 In some embodiments, the system 400 can exchange IDM 402 with IDMs 405 and 406 by using global registration and the sensors themselves. In some embodiments, IDMs 406 and 408 are stored on the system cart 404 at predetermined "docking stations" configured with identification and proximity sensors. The sensors at these docks can utilize technologies such as RFID, optical scanners (e.g., barcodes), EEPROMs, and physical proximity sensors to register and identify which IDMs are "docked" at the docking stations. When the robotic arm 401 and the IDM docking station reside on the system cart 404, the identification and proximity sensors allow the IDM resting on the docking station to be configured relative to the robotic arm(s). Similarly, in embodiments with multiple arms on a single system cart, the multiple arms can access the IDMs on the docking station using a combination of the registration systems and sensors discussed above.

[0099] 5 illustrates a mechanism transformer interface in a robotic system according to an embodiment of the present invention. Figure 5A In particular, the embodiment of the present invention is illustrated to realize the mechanism converter interface of the robot arm connected to the robot system. Figure 5AAs shown, the distal portion of the robotic arm 500 includes an articulated joint 501 coupled to a "male" mechanism converter interface 502. The articulated joint 501 provides additional degrees of freedom relative to manipulating an instrumentation mechanism (not shown) configured to be coupled to the robotic arm 500. The male mechanism converter interface 502 provides a male connector interface 503 that provides a strong physical connection to a complementary female socket connector interface on an IDM (not shown). The spherical indentation on the male connector interface 503 physically couples to a complementary indentation on a female socket interface on the IDM. When pneumatic pressure is transmitted along the robotic arm 500 to the male mechanism converter interface 502, the spherical indentation can be extended. The male mechanism converter interface 502 also provides a connection 504 for transmitting pneumatic pressure to the IDM. Additionally, this embodiment of the mechanism converter interface provides an alignment sensor 505 that ensures that the male mechanism converter interface 502 and its complementary female interface are properly aligned.

[0100] Figure 5B An alternative view of the male mechanism converter interface 502 separated from the robot arm 500 is shown. Figure 5A As discussed, male mechanism transducer interface 502 provides a flanged male connector interface 503, a pneumatic connector 504, and an alignment sensor 505. Additionally, an electrical interface 506 (not shown) is provided for connecting electrical signals to a complementary interface on the IDM.

[0101] Figure 5C Illustration of the connection to Figure 5A and Figure 5B The convex mechanism converter interface 502 is connected to the complementary concave mechanism converter interface of the instrument manipulator. Figure 5C As shown, the instrument manipulator 507 is coupled to a female mechanism converter interface 508 configured to connect to the male mechanism converter interface 502 on the robotic arm 500. The female mechanism converter interface 508 provides a female socket interface 509 designed to be coupled to the flange-shaped male connector interface 503 of the male mechanism converter interface 502. The female socket interface 509 also provides a groove to grip the spherical indentation on the male connector interface 503. When pneumatic pressure is applied, the spherical indentation on the male connector 503 is extended, and the male connector 503 and the socket interface 509 securely couple the IDM 507 to the robotic arm 500. The complementary female mechanism converter interface 508 is also provided with a pneumatic connector 510 to receive the pneumatic pressure transmitted from the connector 504.

[0102] Figure 5D Pictured Figure 5C508. As previously discussed, the complementary mechanism converter interface 508 includes a socket interface 509, a pneumatic connector 510 for interfacing with the mechanism converter interface 502 on the robot arm 500. In addition, the mechanism converter interface 508 also provides an electrical module 511 for transmitting electrical signals (power, control, sensor) to the module 506 in the mechanism converter interface 502.

[0103] Figure 6 , Figure 7 , Fig. 8A and Figure 8B The diagram shows the Figure 4 The system 400 operates with interchangeable modules. Figure 6 An embodiment of the present invention is illustrated using a single-port laparoscopic instrument 601 connected via an instrument interface 602 on a single robotic arm 603 directed toward the abdomen 604 of a patient 605 .

[0104] Figure 7 An embodiment of the present invention is illustrated with two sets of robotic subsystems 701 and 704, each having a pair of arms 702, 703 and 705, 706, respectively. Connected via instrument interfaces at the distal ends of the arms 702, 703, 705, 706 are laparoscopic instruments 707, 708, 709, 710, respectively, all working together to perform a procedure in a single patient 711.

[0105] Fig. 8A An embodiment of the invention is illustrated having a subsystem 801 with a single robotic arm 802 to which a microscope tool 804 is connected via an instrument interface 803. In some embodiments, the microscope tool 804 may be used in conjunction with a second microscope tool 805 used by a physician 806 to help visualize the surgical area of ​​a patient 807.

[0106] Figure 8B An embodiment of the present invention is illustrated, wherein: Fig. 8A Subsystem 801 can be used in conjunction with subsystem 808 to perform microsurgery. Subsystem 808 provides arms 809 and 810, each with microsurgery tools 811 and 812 connected via instrument interfaces on the respective arms. In some embodiments, one or more arms can pick up and exchange tools within a table or other suitable holding mechanism within reach of the robotic arm, such as a docking station.

[0107] In some embodiments, the mechanism changer interface may be a simple screw used to fasten the associated IDM. In other embodiments, the mechanism changer interface may be a bolt plate with electrical connectors.

[0108] 6. Instrument and Device Manipulator (IDM)

[0109] Fig. 9A A portion of a robotic medical system including a manipulator according to an embodiment of the present invention is illustrated. System 900 includes a partial view of a robotic arm 901, an articulation interface 902, an instrument device manipulator ("IDM") 903, and an endoscopic tool 904. In some embodiments, the robotic arm 901 may be just a link in a larger robotic arm having multiple joints and links. The articulation interface 902 connects the IDM 903 to the robotic arm 901. In addition to the connection, the articulation interface 902 can also transmit pneumatic pressure, power signals, control signals, and feedback signals to and from the arm 901 and the IDM 903.

[0110] The IDM 903 drives and controls the endoscopic tool 904. In some embodiments, the IDM 903 uses angular motion transmitted via an output shaft in order to control the endoscopic tool 904. As discussed later, the IDM 903 may include a gear head, a motor, a rotary encoder, a power circuit, and a control circuit.

[0111] Endoscopic tool 904 may include a shaft 909 having a distal tip and a proximal end. A tool base 910 for receiving control signals and driven from IDM 903 may be coupled to the proximal end of shaft 909. By means of the signals received by tool base 910, the proximal end of shaft 909 may be controlled based on the output shafts 905, 906, 907 and 908 (see Fig. 9B ) to the tool base 910 of the endoscopic tool 904 to control, manipulate and guide the axis 909 of the endoscopic tool 904.

[0112] Fig. 9B Pictured Fig. 9A Alternative views of the disclosed robotic medical system. Fig. 9B In FIG. 9 , the endoscope tool 904 has been removed from the IDM 903 to reveal the output shafts 905, 906, 907 and 908. Additionally, removal of the outer skin / shell of the IDM 903 reveals the components underneath the IDM top cover 911.

[0113] Fig.10 FIG. 1 is a diagram showing a tension detection device according to an embodiment of the present invention. Fig. 9A , Fig. 9B903. In the cross-sectional view 1000 of IDM 903, parallel drive units 1001, 1002, 1003 and 1004 are the largest components in the structure of IDM 903. In some embodiments, from the proximal end to the distal end, drive unit 1001 may include a rotary encoder 1006, a motor 1005 and a gear head 1007. Drive units 1002, 1003 and 1004 can be similarly constructed, that is, including a motor, an encoder and a gear head under the top cover 911. In some embodiments, the motor used in the drive unit is a brushless motor. In other embodiments, the motor can be a DC servo motor.

[0114] The rotary encoder 1006 monitors and measures the angular velocity of the drive shaft of the motor 1005. In some embodiments, the rotary encoder 1006 can be a redundant rotary encoder. The structure, capabilities, and use of suitable redundant encoders are disclosed in U.S. Provisional Patent Application No. 62 / 037,520 filed on August 14, 2014, the entire contents of which are incorporated herein by reference.

[0115] The torque generated by the motor 1005 can be transmitted to the gear head 1007 through a shaft coupled to the rotor of the motor 1005. In some embodiments, the gear head 1007 can be attached to the motor 1005 to increase the torque output by the motor at the expense of rotational speed. The increased torque generated by the gear head 1007 can be transmitted to the gear head shaft 1008. Similarly, the drive units 1002, 1003 and 1004 transmit their respective torques out through the gear head shafts 906, 907 and 908.

[0116] Each individual drive unit can be coupled to a motor mount at its distal end and a strain gauge mount toward its proximal end. For example, the distal end of drive unit 1001 can be clamped to motor mount 1009 and strain gauge mount 1001. Similarly, drive unit 1002 can be clamped to motor mount 1011, while both are also clamped to strain gauge mount 1010. In some embodiments, the motor mount is constructed of aluminum to reduce weight. In some embodiments, the strain gauge mount can be adhered to one side of the drive unit. In some embodiments, the strain gauge mount can be constructed of aluminum to reduce weight.

[0117] Electrical strain gauges 1012 and 1013 are packaged and welded to strain gauge mount 1010 and attached to motor mounts 1009 and 1011, respectively, using screws. Similarly, a pair of strain gauges (not shown) proximate drive units 1003 and 1004 are packaged and welded to strain gauge mount 1014 and attached to motor mounts 1015 and 1016, respectively, using screws. In some embodiments, the electrical strain gauges can be held in place relative to their respective motor mounts using side screws. For example, side screw 1019 can be inserted into motor mount 1009 to hold strain gauge 1012 in place. In some embodiments, the strain gauge wiring in the electrical strain gauges can be arranged vertically to detect any vertical strain or flexure in the drive unit, which can be measured as a horizontal displacement by the motor mounts (1009, 1011) relative to the strain gauge mount (1010).

[0118] The strain gauge wiring can be routed to circuits on the strain gauge mount. For example, strain gauge 1012 can be routed to circuit board 1017, which can be mounted on strain gauge mount 1010. Similarly, strain gauge 1013 can be routed to circuit board 1018, which can also be mounted on strain gauge mount 1010. In some embodiments, circuit boards 1017 and 1018 can process or amplify signals from strain gauges 1012 and 1013, respectively. The close proximity of circuit boards 1017 and 1018 to strain gauges 1012 and 1013 helps reduce the signal-to-noise ratio to obtain more accurate readings.

[0119] Fig.11A Pictured from another angle Fig. 9A , Fig. 9B and Fig.10 A cross-sectional view of an independent drive mechanism. Fig.11A As shown, a portion of the housing / skin 1101 has been cut away to reveal the internal structure of the IDM 903. As previously discussed, the drive unit 1001 includes a motor 1005, a rotary encoder 1006, and a gear head 1007. The drive unit 1001 can be coupled to a motor mount 1009 and pass through a top cover 911, through which the output shaft 905 can be driven at a desired angular velocity and torque. The motor mount 1009 can be coupled to a vertically aligned strain gauge 1012 using side screws. In addition to being coupled to the motor mount 1009, the strain gauge 1012 can be encapsulated into the strain gauge mount 1010. In some embodiments, the output shaft 905 includes a labyrinth seal on the gear head shaft.

[0120] Fig. 11B 1 shows a cross-sectional view of the separate drive mechanism discussed previously in conjunction with the endoscopic tool according to an embodiment of the present invention. Fig. 11BAs shown, an endoscopic tool 904 mounted on an IDM 903 includes a pulley longitudinally aligned with the output shaft of the IDM 903, such as a pulley 1102 that may be concentric with the output shaft 905. The pulley 1102 may be housed within a precision cutting chamber 1103 within the tool base 910, such that the pulley 1102 may not be rigidly fixed within the chamber 1103, but rather "floats" within the space in the chamber 1103.

[0121] The splines of pulley 1102 are designed so that they align with and lock with the splines on output shaft 905. In some embodiments, the splines are designed so that only a single orientation of the endoscopic tool may be aligned with IDM 903. Although the splines ensure that pulley 1102 is concentrically aligned with output shaft 905, pulley 1102 can also incorporate a floating pulley 1102 that is positioned and axially maintained in alignment with output shaft 905 using magnets 1104. Locked into alignment, rotation of output shaft 905 and pulley 1102 tensions the pull wire within endoscopic instrument 904, creating an articulation of shaft 909.

[0122] Fig.12 An alternative view from the previously discussed independent drive mechanism with pull wires from an endoscopic tool according to an embodiment of the present invention is illustrated. In some embodiments, the endoscopic tool may use pull wires to articulate and control the axis. In those embodiments, these pull wires 1201, 1202, 1203, and 1204 may be tightened or loosened by the output shafts 905, 906, 907, and 908 of the IDM 903, respectively. Thus, the pull wires may be controlled by the robot via the control circuitry in the IDM 903.

[0123] Just as the output shafts 905, 906, 907 and 908 transmit forces along the cables 1201, 1202, 1203 and 1204 through angular motion, the cables 1201, 1202, 1203 and 1204 transmit forces back to the output shafts and thus to the motor mounts and drive units. For example, tension in the cables directed away from the output shafts creates a force that pulls on the motor mounts 1009 and 1011. Because the strain gauges are both coupled to the motor mounts 1009 and 1011 and are enclosed in the strain gauge mount 1010, this force can be measured by the strain gauges (such as 1012 and 1013).

[0124] Fig.13A conceptual diagram showing how a horizontal force can be measured by a strain gauge oriented perpendicular to the force is illustrated in accordance with an embodiment of the present invention. As shown in FIG. 1300 , a force 1301 can be directed away from an output shaft 1302. When the output shaft 1302 is coupled to a motor mount 1303, the force 1301 produces a horizontal displacement of the motor mount 1303. When the motor mount 1303 causes the strain gauge 1304 to flex (cause strain) in the direction of the force 1301, the strain gauge 1304 coupled to both the motor mount 1303 and the ground 1305 may thereby experience strain. The amount of strain can be measured as the ratio of the horizontal displacement of the tip of the strain gauge 1304 to the overall horizontal width of the strain gauge 1304. Therefore, the strain gauge 1304 can ultimately measure the force 1301 applied to the output shaft 1302.

[0125] In some embodiments, the assembly may include a device to measure the orientation of the instrument manipulator 903 (such as an inclinometer or accelerometer). In conjunction with the strain gauges, the measurements from the device may be used to calibrate the readings from the strain gauges, since the strain gauges may be sensitive to the effects of gravity loads resulting from their orientation relative to the ground. For example, if the instrument manipulator 903 is oriented on its side, the weight of the drive unit may produce strain on the motor mount that may be transmitted to the strain gauge even though the strain may not result from strain on the output shaft.

[0126] In some embodiments, the output signal from the strain gauge circuit board can be coupled to another circuit board for processing the control signal. In some embodiments, the power signal is routed from the circuit board processing the control signal to a drive unit on another circuit board.

[0127] As previously discussed, the motors in drive units 1001, 1002, 1003, and 1004 ultimately drive output shafts, such as output shafts 905, 906, 907, and 908. In some embodiments, the output shafts may be reinforced with a sterile barrier to prevent fluid from entering the instrument manipulator 903. In some embodiments, the barrier may utilize a labyrinth seal ( Fig.11A 1105) to prevent fluid ingress. In some embodiments, the distal end of the gear head shaft can be covered with an output shaft to transmit torque to the tool. In some embodiments, the output shaft can be wrapped in a steel cap to reduce magnetic permeability. In some embodiments, the output shaft can be clamped to the gear head shaft to assist in the transfer of torque.

[0128] The instrument device mechanism 903 may also be covered with a shell or skin, such as housing / skin 1101. In addition to being aesthetically pleasing, the shell provides fluid ingress protection during surgery (e.g., during a medical procedure). In some embodiments, the shell may be constructed using cast polyurethane for electromagnetic shielding, electromagnetic compatibility, and electrostatic discharge protection.

[0129] In an embodiment of the present invention, each of those output shafts that are individually tensioned can pull a wire in an endoscopic tool utilizing steerable catheter technology. The tension in the pull wire can be transmitted to the output shafts 905, 906, 907, and 908 and down to the motor mounts, such as motor mounts 1009 and 1011.

[0130] 7. Endoscopic tool design

[0131] In a preferred embodiment, Figure 1 The robotic system 100 can drive tools customized for intracavitary procedures, such as endoscopic tools 118. Fig.14 According to an embodiment of the present invention, it can be combined Figure 1 14. An illustration of an endoscopic tool used with the robotic system 100. The endoscopic tools 1400 can be arranged around longitudinally aligned nested tubular bodies (referred to as "sheaths" and "guides"). The sheath 1401 (the tubular tool with the larger outer diameter) can include a proximal sheath segment 1402, a distal sheath segment 1403, and a central sheath lumen (not shown). The distal sheath segment 1403 can be articulated in a direction desired by the operator by signals received in the sheath base 1404. Nested within the sheath 1401 can be a guide 1405 with a smaller outer diameter. The guide 1405 can include a proximal guide segment 1406 and a distal guide segment 1407, and a central working channel. Similar to the sheath base 1404, the guide base 1408 is based on signals communicated to the guide base 1408, typically from the IDM (e.g., Fig. 9A 903) to control the joint connection of the distal guide segment 1407 using a control signal from the guide base 1408.

[0132] Both the sheath mount 1404 and the guide mount 1408 have similar drive mechanisms to which control ribs within the sheath 1401 and guide 1405 are anchored. For example, manipulation of the sheath mount 1404 can place tensile loads on the ribs in the sheath 1401, causing deflection of the distal sheath segment 1403 therein in a controlled manner. Similarly, manipulation of the guide mount 1408 can place tensile loads on the ribs in the guide 1405 to cause deflection of the distal guide segment 1407. The sheath mount 1404 and the guide mount 1408 can also include couplings for routing pneumatic pressure, electrical power, electrical signals, or optical signals from the IDM to the sheath 1401 and guide 1404.

[0133] The control ribs within the sheath 1401 and guide 1405 can be routed through the articulation segment to an anchor located at the distal end of the articulation segment. In a preferred embodiment, the ribs within the sheath 1401 and guide 1405 can be composed of stainless steel control ribs routed through a stainless steel coil (such as a coil). It will be appreciated by those skilled in the articulation that other materials can also be used for the ribs, such as aramid, tungsten, and carbon fiber. Placing a load on these ribs causes the distal segment of the sheath 1401 and guide 1405 to deflect in a controlled manner. The inclusion of the coil along the length of the ribs within the sheath 1401 and guide 1405 can transfer axial compression back to the origin of the load.

[0134] Using multiple tendons, the endoscope tool 1400 has the ability to easily navigate a lumen within the human body by providing multiple control degrees of freedom (each corresponding to a separate tendon) at two points along its length (the distal sheath segment 1403 and the distal guide segment 1407). In some embodiments, up to four tendons can be used for the sheath 1401 and / or the guide 1405, providing up to eight degrees of freedom combined. In other embodiments, up to three tendons can be used, providing up to six degrees of freedom.

[0135] In some embodiments, the sheath 1401 and guide 1405 can be wound 360 degrees, providing even more tool flexibility. The combination of the winding angle, multiple degrees of articulation, and multiple points of articulation provide the physician with a significant improvement in instinctive control of the device as tortuous paths are navigated within the human body.

[0136] Fig.15A , Fig. 15B , Fig. 15C , Fig.16A and Fig. 16B Various aspects of the robotically driven endoscopic tool of FIG. 2 , such as sheath 210 and guide 212 , are generally illustrated in accordance with an embodiment of the present invention. Fig.15AAn endoscopic tool is illustrated having a sheath 1500 with a distal end 1501 and a proximal end 1502 and a lumen 1503 running between the two ends. The lumen 1503 may be sized to slidably receive a flexible endoscope (such as the guide 1600 of FIG. 16 ). The sheath 1500 has a wall 1504 with ribs 1505 and 1506 running inside the length of the wall 1504 of the sheath 1500. The ribs 1505 and 1506 may slidably pass through conduits 1507 and 1508 in the wall 1504 and terminate at the distal end 1501. In some embodiments, the ribs may be formed of steel. Properly tensioning the ribs 1505 may compress the distal end 1501 toward the conduit 1507 while minimizing bending of the helical segment 1510. Similarly, properly tensioning the ribs 1506 may compress the distal end 1501 toward the conduit 1508. In some embodiments, lumen 1503 may not be concentric with sheath 1500 .

[0137] Fig.15A The ribs 1505 and 1506 of the sheath 1500 and the associated conduits 1507 and 1508 preferably do not run straight along the entire length of the sheath 1500, but spiral around the sheath 1500 along the helical segment 1510 and then run straight longitudinally (i.e., generally parallel to the neutral axis) along the distal segment 1509. It should be understood that the helical segment 1510 can start at the proximal end of the distal segment 1509 extending proximally along the sheath 1510 and can terminate at any desired length with any desired or variable pitch. The length and pitch of the helical segment 1510 can be determined based on the desired characteristics of the sheath 1500 taking into account the desired flexibility of the shaft and the increased friction in the helical segment 1510. When not in a helical segment (such as the proximal and distal segments of the endoscope 1500), the ribs 1505 and 1506 can run generally parallel to the central axis 1511 of the sheath 1500.

[0138] In some embodiments, the tendon conduits may be at ninety degree angles to each other (e.g., 3 o'clock, 6 o'clock, 9 o'clock, and 12 o'clock). In some embodiments, the tendons may be spaced 120 degrees apart from each other, e.g., three tendons total. In some embodiments, the tendons may be spaced unequally apart. In some embodiments, they may be toward one side of the central lumen. In some embodiments, the tendon count may be different than three or four.

[0139] Fig. 15B A three-dimensional illustration of an embodiment of a sheath 1500 is shown having only one rib for the purpose of clarifying the distinction between the non-helical segments 1509 and the variable pitch helical segments 1510. Although one rib may be used, it may be preferred to use multiple ribs. Fig. 15CA three-dimensional illustration of an embodiment of a sheath 1500 showing four ribs extending along a distal segment 1509 and a variable pitch helical segment 1510 .

[0140] Fig.16A An endoscope guide 1600 having a distal end 1601 and a proximal end 1602 is illustrated, which is sized to slidably reside within the sheath 1500 of FIG. 15. The guide 1600 may include at least one working channel 1603 therethrough. The proximal end 1502 of the sheath 1500 and the proximal end 1602 of the guide 1600 are operably connected to the tool bases 206 and 208 of FIG. 2, respectively. Ribs 1604 and 1605 slide through conduits 1606 and 1607, respectively, in the wall 1608 and terminate at the distal end 1601.

[0141] Fig. 16B The distal end 1601 of a guide 1600 (an exemplary embodiment) is illustrated having imaging 1609 (e.g., a CCD or CMOS camera, the end of an imaging fiber bundle, etc.), a light source 1610 (e.g., an LED, an optical fiber, etc.), and may include at least one working channel opening 1603. Other channels or operating electronics 1606 may be provided along the guide 1600 to provide various known capabilities at the distal end, such as wiring to a camera, insufflation, suction, power, optical fibers, ultrasound transducers, EM sensing, and OCT sensing.

[0142] In some embodiments, the distal end 1601 of the guide 1600 may include a "pocket" for inserting a tool, such as those disclosed above. In some embodiments, the pocket may include an interface for controlling the tool. In some embodiments, there may be a cable (such as an electrical or optical cable) to communicate with the interface.

[0143] In some embodiments, Fig.15A The sheath 1500 and Fig.16A Both the guide 1600 and the sheath 1500 can have a robotically controlled maneuverable distal end. The structure of the sheath 1500 and the guide 1600 that enable the control can be substantially the same. Therefore, the discussion of the construction of the sheath 1500 will be limited to the construction of the sheath 1500, and it should be understood that the same principles apply to the structure of the guide 1600.

[0144] Therefore, from Fig.16AThe ribs 1604 and 1605 and associated conduits 1606 and 1607 of the guide 1600 do not run longitudinally straight (i.e., generally parallel to the neutral axis) along the length of the guide 1600, but instead spiral along different portions of the guide 1600. As with the spiral ribs and conduits in the sheath 1500, the spiral ribs of the guide 1600 can be determined based on the desired characteristics of the guide taking into account the desired flexibility of the shaft and the increased friction of the spiral segments. When not in the spiral segments, the ribs 1604 and 1605 run generally parallel to the central axis of the guide 1600.

[0145] The helical segment, as described more fully below, can help isolate bending to the distal segment while minimizing any bending that occurs along the shaft proximal to the distal segment. In some embodiments of the present invention, the helical pitch of the catheter in the sheath 1500 and guide 1600 can vary along the length of the helical segment, which, as described more fully below, will change the stiffness / rigidity of the shaft.

[0146] The use of a helical catheter and helical tendons in the sheath 1500 and guide 1600 presents significant advantages over previous flexible instruments without a helical catheter, particularly when navigating non-linear pathways in anatomy. When navigating a curved pathway, it may be preferred that the sheath 1500 and guide 1600 remain flexible over a majority of their length and have a controllable and steerable distal segment, while also having minimal secondary bending of the instrument proximal to the distal curved segment. In previous flexible instruments, tensioning the tendons to articulate the distal end resulted in undesirable bending and twisting along the entire length of the flexible instrument, which may be referred to as "muscle development" and "curve alignment," respectively.

[0147] FIG. 17A to FIG. 17D The figure shows how prior art flexible instruments exhibit undesirable "muscle development" when the tendons are stretched. Fig.17A In the previous endoscope 1700, the length of the endoscope 1700 may have four ribs or control wires running generally parallel to the neutral axis 1701. Ribs 1702 and 1703 are shown only in cross section, running through conduits 1704 and 1705 (also referred to as control lumens) in the shaft wall, each of which is fixedly connected to a control ring 1706 on the distal end of the endoscope 1700. The endoscope 1700 may be intentionally designed to have a curved section 1707 and a shaft 1708. In some flexible instruments, the shaft 1708 may include a stiffer material, such as stiffeners.

[0148] Fig. 17BAn idealized articulation of the curved segment 1707 is shown. By pulling or applying tension to the tendon 1703, only the articulation of the distal curved segment 1707 results in a quantity represented by φ, where the length difference at the proximal ends of the tendons 1702 and 1703 may be f(φ). In contrast, the shaft 1708 may remain straight along the neutral axis 1701. This may be achieved by having a proximal region 1708 that is significantly stiffer than the distal region 1707.

[0149] Fig. 17C The real world generated from the tensioner 1703 is shown. Fig. 17C As shown, when tension is non-localized, the pull tendons 1703 produce compressive forces along the entire length of the shaft. In an ideal case, along the neutral axis 1701 are tendons 1703, the overall compressive load may also be transmitted along the central axis and most or all of the bending may occur in the curved segment 1707. However, when tendons 1703 are running along the periphery of the shaft 1708 (such as in the endoscope 1700), the axial load is transmitted out of the neutral axis 1701 in the same radial orientation of the neutral axis that produces a cumulative moment along the neutral axis. This causes the shaft 1708 to bend (depicted as θ), where the bending of the shaft 1708 will be in the same direction as the bending of the curved segment 1707. When the endoscope 1700 and the distal curved segment 1707 bend, the length along the catheter 1704 and the catheter 1705 must change. When the tendons 1703 need to be shortened and the tendons 1702 need to be lengthened, the number of tendons 1702 and 1703 extending from the proximal end is f(φ,θ). This phenomenon in which the shaft 1707 and the distal curved section 1708 bend from the pull muscle 1703 is called "muscle development".

[0150] Fig.17D The diagram shows the forces that contribute to three-dimensional muscle development. Fig.17D As shown, tensioning tendons 1703 along endoscope 1700 causes tendons 1703 to apply force 1712 directionally toward one side of the instrument. The direction of force 1712 reflects the tension in tendons 1703 causing the tendons to seek to follow a straight line from the tip of the distal curved segment 1707 to the base of shaft 1708, i.e., the lowest energy state as represented by dashed line 1713. As should be appreciated, if shaft 1708 is rigid (i.e., not susceptible to bending under force), only the distal curved segment 1707 will bend. However, in many applications, it is undesirable to make the rigidity of the shaft completely different from that of the distal end to fully minimize the muscle development phenomenon.

[0151] FIG. 17E to FIG. 17H The diagram illustrates how previous flexible instruments have suffered from curve alignment phenomena during use in non-linear pathways. Fig.17EA prior flexible endoscope 1700 is shown at rest within a nonlinear path represented by a bend τ along the axis 1708 of the endoscope 1700. This may be produced, for example, by an instrument navigating across a bend in the lumen of a bronchial tube. Due to the nonlinear bend, the tendons 1702 and 1703 in the endoscope 1700 need to be extended or shortened by a length at the proximal end to accommodate the nonlinear bend, the length of which is represented by F(τ). Extension and compression forces exist on the lumen / catheter at the top and bottom of the bend, as depicted by arrows 1709 (extension force) and 1710 (compression force), respectively. These forces exist because the distance along the top of the bend is longer than the neutral axis, and the distance along the inside of the bend is shorter than the neutral axis.

[0152] Fig.17F The mechanics of the distal curved section 1707 of the articulating endoscope 1700 in the same direction as the bend τ are illustrated, where one may pull on tendons 1703. This creates a compressive force along the length of the flexible instrument (as previously described), and tendons 1703 also exert a downward force on the nonlinear catheter through which it passes, which exerts additional compression on the shaft 1708 that was previously compressed by the anatomical tortuosity. Because these compression leads are additional, the shaft 1708 will further bend in the same direction as the distal curved section 1707. The additional compressive forces along the nonlinear catheter may be undesirable because: (i) it may unintentionally impose a flexible instrument on the anatomy; (ii) the possibility of injury distracts the operator because he / she must constantly monitor what the shaft is doing when he / she should be able to "assume" that the anatomy is dictating the contour of the instrument shaft; (iii) it is inefficient in bending the instrument; (iv) it is desirable to isolate the bend at the distal segment to aid predictability and controllability (i.e., an ideal instrument has a curved segment that bends on command and is not a function of the nonlinear path of the anatomy); and (v) it forces the user to stretch tendon 1103 an unpredictable additional length (φ+θ+τ).

[0153] Figure 17G The diagram shows a scenario where it is desired to articulate the distal end opposite to the bend τ, and a tension muscle 1702 is required. The tension muscle 1702 applies a compressive load 1711 along the top of the curve, which is similar to the Fig.17E The extension load of the bend in the static state shown is opposite. The tendon 1702 attempts to return to its lowest energy state, i.e., where the compressive load 1711 rests inside the bend τ, and the shaft 1708 is rotated in the direction of arrow 1712 so that the tendon 1702 rests inside the bend τ. Fig.17HAs shown, the rotation 1712 from the tension on the tendon 1702 moves the compressive load 1711 back inside the bend and causes the distal curved segment 1707 to roll back in the direction of the bend τ, thereby producing an articulation opposite to the intended articulation. The tension on the tendon 1702 and the resulting rotation 1712 in practice returns the endoscope 1700 to the position in which it is intended to be articulated. Fig.17F The same state in which the distal joint joint rolls back toward the flexion τ is referred to as the phenomenon "curve alignment". It should be understood that curve alignment is produced by the same forces that cause muscle development, wherein these forces produce undesirable lateral movement in the case of muscle development and undesirable rotational movement in the case of curve alignment. It should be noted that the discussion of muscle development and theory of curve alignment is not provided by way of limitation, and embodiments of the present invention are not limited in any way to this interpretation.

[0154] Fig.17I and Fig.17J The diagram illustrates how the muscle development and curve alignment phenomena are substantially addressed by providing a helical segment (such as 1510 of FIG. 15 ) in an embodiment of the present invention. Fig.17I As shown, the control lumen around the spiral endoscope 1700 (such as in the spiral segment 1510 of FIG. 15 ) radially distributes the compressive load 1714 from a single tendon 1715 around the endoscope 1700. Because the tensioned tendons 1715 symmetrically transmit the compressive load 1714 in multiple directions around the neutral axis, the bending moment applied to the shaft is also symmetrically distributed around the longitudinal axis of the shaft, which balances and cancels out the opposing compressive and tensile forces. The distribution of the bending moment produces the least net bending and rotational forces, thereby producing the lowest energy state longitudinally parallel to the neutral axis as represented by the dashed line 1816. This eliminates or substantially reduces muscle development and curve alignment phenomena.

[0155] In some embodiments, the helical pitch can be varied to affect the friction and stiffness of the helical segment. For example, the helical segment 1510 can be shorter to allow for a larger non-helical segment 1509, thereby creating a larger articulation segment and potentially less friction.

[0156] However, the spiral control lumen creates several tradeoffs. The spiral control lumen still cannot prevent buckling from tension in the tendons. Additionally, despite greatly reduced muscle development, "spinning" (bending the shaft into a spiral, a spring-like pattern due to tension in the tendons) is very common. Moreover, as the tendons travel longer distances through the lumen, the spiral control lumen needs to compensate for the additional friction.

[0157] Fig.18 The structure of a flexible endoscope tool having an axially rigid tube in a lumen according to an embodiment of the present invention is illustrated. Fig.18In the embodiment of the present invention, a section of the endoscopic tool has a single lumen 1801 with a pull wire 1802 wound in a spiral pattern around the shaft 1800. Inside the lumen, an axially rigid tube 1803 "floats" around the pull wire 1802 and within the lumen 1801. The floating tube 1803 anchored at the beginning and end of the spiral portion of the shaft 1800 extends and compresses in response to the tension in the pull wire 1802 and the external tortuosity, thereby relieving the extension and compression forces of the wall of the lumen 1801. In some embodiments, the tube 1803 can be anchored by a control ring at the beginning and end of the lumen. Alternatively, the tube 1803 can be anchored to the beginning and end of the lumen using solder, welding, gluing, bonding or fusion methods. In some embodiments, geometric joints (such as flared geometry) can be used to anchor the tube 1803. In various embodiments, the tube 1803 can be formed by a hypodermic tube, a coil, a Bowden cable, a torque tube, a stainless steel tube, or a nitinol tube.

[0158] Fig.18 The embodiment in can be constructed by fixedly attaching the tube to the distal and proximal end pieces and twisting the tube together by rotating either or both end pieces. In this embodiment, the rotation of the end piece(s) ensures that the tube is spiraled in the same pitch, manner and orientation. After rotation, the end piece can be fixedly attached to the lumen to prevent further rotation and limit changes to the spiral pitch.

[0159] Fig.19 The structure of the spiral pattern in the lumen of the flexible endoscopic instrument according to an embodiment of the present invention is shown. Fig.19 16 , lumen 1900 includes structures 1901 and 1902 that form a spiral or helical pattern along its wall. In a preferred embodiment, the structure is formed of an axially rigid and tubular material. In some embodiments, the structure can be formed of a hypodermic injection tube ("hypo tube"), a coil, or a torque tube. As shown by structures 1901 and 1902, the structure can have different starting points along the wall of lumen 1900. The materials, composition, and characteristics of structures 1901 and 1902 can also be selected and configured for the desired stiffness and length. The pitch of the spiral pattern formed by structures 1901 and 1902 can also be configured for the desired stiffness and flexibility of lumen 1900. In some embodiments, lumen 1900 can be the main central lumen of a flexible endoscope, such as guide 1600 of FIG. 16 .

[0160] Fig. 20AAn endoscopic tool from a robotic endoluminal system according to an embodiment of the present invention is illustrated. The endoscopic tool 2000 may include a flexible shaft segment 2001 proximal to a support base (not shown) and a flexible articulation segment 2002 coupled to a distal tip 2003. Similar to the guide 2005, the endoscopic tool 2000 may be articulated by placing a tensile load on tendons within the shaft.

[0161] Fig. 20B Pictured Fig. 20A Alternative views of the endoscopic instrument 2000. Fig. 20B As shown, the distal tip 2003 may include a working channel 2004, four light emitting diodes 2005, and a digital camera 2006. In conjunction with the LEDs 2005, the digital camera 2006 may be used, for example, to capture real-time video to aid navigation within an anatomical lumen. In some embodiments, the distal tip 2003 may include an integrated camera assembly that houses a digital imaging device and an illumination device.

[0162] Working channel 2004 can be used for the passage of intraoperative instruments (such as flexible pieces of precision articulation at the surgical site). In other embodiments, working channels can be combined to provide additional capabilities, such as flushing, suction, lighting or laser energy. The working channel may also be conducive to routing control tendon assemblies and other lumens required for the above-mentioned additional capabilities. The working channel of the endoscopic tool can also be configured to deliver a variety of other therapeutic substances. This substance can be cryogenic for ablation, radiation or stem cells. These substances can be accurately delivered to the target site using the insertion, articulation and capabilities of the endoscopic tool of the present invention. In some embodiments, the diameter of the working channel can be as small as 1.2 millimeters.

[0163] In some embodiments, an electromagnetic (EM) tracker may be incorporated into the distal tip 2003 to aid in positioning. As will be discussed later, a static EM field generator may be used to determine the position of the EM tracker, and thus the distal tip 2003, in real time.

[0164] The image from the camera 2006 may be ideal for navigating in the anatomical space. Therefore, internal body fluids (such as mucus) obscuring the camera 2006 may cause problems when navigating. Therefore, the distal end 2003 of the endoscope tool 2000 may also include a device for cleaning the camera 2006, such as a device for flushing and suctioning the camera lens. In some embodiments, the working channel may contain a balloon that can be filled with fluid around the camera lens and suctioned once the lens is clear.

[0165] Endoscopic tool 2000 enables delivery and manipulation of small instruments within the endoluminal space. In a preferred embodiment, the distal tip can be miniaturized for performing endoluminal procedures, maintaining an outer diameter of no more than three millimeters (ie, 9 millimeters in France).

[0166] Fig.21 The distal end of an endoscopic tool according to an embodiment of the present invention is shown. Fig.21 As shown, the endoscopic tool 2100 includes a distal end 2101 having a housing 2102. The housing 2102 can be constructed of several materials including stainless steel and polyetheretherketone (PEEK). The distal end 2101 can be filled with a working channel 2103 for slidingly providing tool access and control. The distal end 2101 also provides an array of light emitting diodes 2104 for illumination using a camera 2105. In some embodiments, the camera can be part of a larger sensor assembly, which includes one or more computer processors, a printed circuit board, and a memory. In some embodiments, the sensor assembly can also include other electronic sensors, such as gyroscopes and accelerometers (uses discussed later).

[0167] 8. Endoscopic tool manufacturing

[0168] In the background art, steerable catheters are traditionally manufactured by braiding wires or fibers (i.e., braided wires) around a process mandrel having a tube drawing lumen in a braiding machine (i.e., a braider) and a polymer jacket coated on the braided wire. Embodiments of sheaths and guides for endoscopic tools can be constructed using various aspects of the steerable catheter construction method.

[0169] Fig. 22 A flow chart for constructing an endoscopic device having a spiral lumen according to an embodiment of the present invention is illustrated. Initially, in step 2201, a primary process mandrel can be selected to create a cavity in an endoscope that can be used as a central lumen of a working channel. An auxiliary mandrel can be selected to create a cavity in the wall of an endoscope for use as a control (traction) lumen. The primary process mandrel can exhibit an outer diameter that is larger than the auxiliary mandrel outer diameter (OD) to reflect the relative size difference between the working channel and the traction lumen. The auxiliary mandrel can be constructed of a metal or thermosetting polymer that may or may not be coated with a lubricious coating (such as PTFE).

[0170] In step 2202, the main process mandrel can be inserted into the feed tube of the braider, which rotates relative to the fixed braiding cone support tube and the braiding cone holder. Similarly, the auxiliary mandrel can also be inserted into the feed tube in a manner parallel to the main process mandrel. In traditional endoscope configurations, a smaller auxiliary mandrel is used for braiding through the center of the angle gear.

[0171] In step 2203, using a puller with a tread, the primary process mandrel can be advanced through the feed tube. As the primary process mandrel is advanced, it eventually emerges through the center hole in the nose cone. Similarly, the auxiliary mandrel is advanced through to also emerge through the outer hole in the nose cone. This is in contrast to conventional endoscope configurations, where the auxiliary mandrel is typically advanced through a separate feed tube to emerge from the center of the angle gear.

[0172] In step 2204, as the primary process mandrel and the auxiliary mandrel emerge through the nose cone, they are braided together using braiding wire. The nose cone provides a rounded smooth shape on which the braiding wire from the surrounding angular gears can slide easily around the primary process mandrel during the braiding process. As the primary process mandrel and the auxiliary mandrel emerge from the nose cone, the nose cone rotates, thereby ensuring that the auxiliary mandrel in the outer hole is braided in a spiral manner around the primary process mandrel. As the primary process mandrel and the auxiliary mandrel are braided together, the angular gears translate and rotate to place the braiding wire around the primary process mandrel and the auxiliary mandrel in a predetermined pattern and density.

[0173] This braiding method is significantly different from conventional endoscope construction methods, in which the nose cone is typically held in a radially fixed position relative to the braid cone holder using a set screw keyed to the braid cone holder. Therefore, the braiding process requires specialized software in order to manufacture a catheter-like endoscope with a helical control lumen.

[0174] Fig.23 A dedicated system for manufacturing an endoscope with a helical pull lumen according to an embodiment of the present invention is illustrated. In system 2300, a nose cone 2301 can be fixedly coupled to a rotating feed tube 2302 using a set screw that holds the nose cone 2301 in a fixed position relative to the feed tube 2302. Thus, when the feed tube 2302 rotates, the nose cone 2301 rotates. In contrast, conventional systems typically use a set screw to fixedly couple the nose cone 2301 to a non-rotating braided cone support holder 2305.

[0175] The center hole 2303 of the nose cone 2301 can be aligned with the rotating feed tube 2302 so that the main process mandrel 2304 can be smoothly pulled through the two structures. In some embodiments, the outer diameter of the rotating feed tube 2302 is smaller than the inner diameter of the braiding cone support tube 2306 (also referred to as the mandrel guide tube), and the inner diameter is larger than the circumferential space of the center hole 2303 of the nose cone 2301. The rotating feed tube 2302 can generally be large enough for the main process mandrel 2304 and the auxiliary mandrel to pass through the nose cone 2301 without getting tangled. In some embodiments, the rotating feed tube 2302 can be long enough to pass through the center of the angle gear of the braider. In some embodiments, the rotating feed tube 2302 can be attached to a mechanism that can hold a spool of material of the auxiliary mandrel that is passed through the feed tube 2302 to the auxiliary hole around the nose cone 2301.

[0176] In some embodiments, the feed tube 2302 can be attached to a drive mechanism that controls the rotation speed of the feed tube 2302 and thus the rotation of the nose cone 2301. In some embodiments, the drive mechanism can be a rotating gear 2307. When the braider is braiding the braiding wire 2308 around the main process mandrel 2304, the drive mechanism gear is connected to the braider itself or is independently controlled to change or keep the rotation speed of the rotating feed tube 2302 and therefore the rotation speed of the nose cone 2301 constant. The rotation speed and the braiding speed will control the pitch of the auxiliary mandrel on the main process mandrel 2304. As discussed previously, this may affect the flexibility, stiffness and "pushability" of the device.

[0177] Fig.24 A special nose cone for manufacturing a spiral lumen in an endoscopic device according to an embodiment of the present invention is illustrated. Rotating the nose cone while the main process mandrel is pulled through the nose cone allows auxiliary mandrels 2402, 2403 and 2404 to be applied in a spiral pattern around mandrel 2401 through auxiliary holes 2405, 2406 and 2407 surrounding central hole 2408, respectively, similar to how an angular gear weaves a braided wire around the main process mandrel 2401.

[0178] In another embodiment, changing the circumferential orientation of the pull lumen can change the stiffness of the helical segment of the endoscope. In manufacturing, this can be achieved by changing the pitch of the auxiliary helical mandrel. When the pitch of the mandrel (i.e., the angle away from the longitudinal axis) increases, the bending stiffness of the braided composite material decreases. Conversely, when the pitch of the auxiliary mandrel decreases, the bending stiffness increases. Fig. 15B As shown, in some embodiments, the pitch of the auxiliary mandrel may vary within the helical portion (1510). In those embodiments, the bending stiffness of the braided composite material may even vary within the helical portion.

[0179] Return to Fig. 22 In step 2205, after the braiding process is completed, the polymer coating or jacket can be sheathed, heated and bonded to the braided composite material. The polymer coating can also be applied to the extrusion or film casting process. In step 2206, after bonding, the mandrel can be removed from the braided composite to create a central lumen or working channel for cameras and light tools (main process mandrel), and several control lumens for steering control (auxiliary mandrel). The braided composite material with the mandrel removed can be completed (2207).

[0180] During the braiding process, the braiding machine may be stopped to make changes to the braided composite material. In some embodiments, a change may be to add a flat line or a reinforcing rod. The reinforcing rod may significantly change the buckling, axial and bending stiffness of the braided laminated composite material. The reinforcing rod may be particularly helpful for longer endoscopes that may require a special anti-buckling structure or manual assistance to reduce the buckling of the device so that it can be inserted into the patient's body. In some embodiments, the braiding machine can be configured to selectively braid the reinforcing rod that may be pulled from the hole in the nose cone to the main process mandrel, wherein the reinforcing rod is captured and held in place by the braiding line. The absence of a reinforcing rod in the distal region of the resulting endoscope retains the flexibility of the device at the distal end while increasing the rigidity of the proximal region. The combination of characteristics makes it easier for the physician to navigate the resulting endoscope, insert the device and push it into the patient's intraluminal cavity.

[0181] The use of a hole in a rotating nose cone to apply the auxiliary mandrel to the main process mandrel provides several manufacturing advantages. By using the hole in the nose cone, the mandrel is not pushed from the angle gears. Pushing the mandrel from the center of the various angle gears that are also responsible for weaving the braided wires causes the mandrel to be interwoven with the braided wires, which locks the resulting braided matrix in place longitudinally. This form of construction (referred to as a "zero degree construction") limits the ability of the manufacturer to adjust the braid matrix for ideal flexibility or hoop strength. In the zero degree construction, the auxiliary mandrel is necessarily constrained to braiding in an "up and down manner", resulting in all clockwise braided wires being woven "on" the auxiliary mandrel, while all counterclockwise braided wires are manufactured "under" the auxiliary mandrel. When the zero degree construction locks the auxiliary mandrel radially in place, the need to change the pitch of the auxiliary mandrel along the main process mandrel may be undesirable.

[0182] Additionally, the use of the angle gear as a pass through for the auxiliary mandrels limits the number of auxiliary mandrels that can be applied to the main process mandrel. For example, a sixteen-spindle carrier braider can apply up to eight mandrels at most, a twenty-four-spindle braider can only have up to twelve mandrels. In contrast, the use of the holes in the nose cone allows any number of mandrels to pass through to the main process mandrel.

[0183] In some embodiments, the auxiliary mandrel can be applied to the main process mandrel without the benefit of a second outer layer of braid. Conversely, the auxiliary mandrel can be applied without a braid. In those embodiments, a bonded / fused polymer jacket can hold the mandrel and therefore the lumen in place. Alternatively, in some embodiments, the mandrel can be held in place using a casting around the braided composite. Because there is no outer braid in manufacturing the endoscopic tool, the diameter and circumference of the cross-section of the device are reduced. Alternatively, the auxiliary mandrel can be held in place by putting a polymer jacket over the main process mandrel. In some embodiments, the casting can be the same material as the outer material used for the endoscopic tool.

[0184] In some embodiments, the auxiliary mandrel can be woven onto the main process mandrel much like a braiding thread. For example, in some embodiments, an auxiliary mandrel can be woven using an even number of angle gears while being held in place by a braiding thread woven using an odd number of angle gears. In this way, the auxiliary mandrel and therefore the lumen can be woven into the wall of the central lumen. As an added benefit, embodiments manufactured using this process also tend to have a lower circumferential area.

[0185] Alternatively, in some embodiments, an extrusion die can be used to manufacture a spiral lumen structure. These dies can generate a spiral lumen structure to create a coat from PTFE, polyetheramide (pebax), polyurethane, and nylon. In some embodiments, a die can be used to form an extruded structure around a braided mandrel.

[0186] In some embodiments, the spiral lumen configuration can be performed by rotating the main process mandrel as it is pulled through the braider. By rotating the main process mandrel instead of the nose cone, the auxiliary mandrel can be pulled through the fixed nose cone or through the angle gear during the braiding process. In this embodiment, the nose cone can be fixedly coupled to the nose cone holder, and the main process mandrel is pulled through the nose cone by rotating the nose cone.

[0187] The construction of the sheath 1500 of Figure 15 and the guide 1600 of Figure 16 are substantially the same. Therefore, it should be understood by those skilled in the art that the same principles apply to both tools.

[0188] 9. Intracavitary navigation

[0189] In an embodiment of the present invention, navigating an endoscopic tool through an anatomical lumen may involve using a computer to generate a three-dimensional map based on a collection of two-dimensional images created by low-dose computed tomography (CT) scans. Two-dimensional CT scans, each representing a cross-sectional view of the patient's internal anatomy, may be collected during a preoperative procedure. These scans may be analyzed to determine cavities and anatomical spaces within the patient's body, such as the branches of a lung or the path of the urethra.

[0190] An analysis has been performed to determine relevant anatomical spaces within a patient's body that can be expressed as lumens with centerline coordinates (i.e., coordinates representing the center of the lumen) in three-dimensional space. The volumes of those lumens can be expressed as specific measurements of diameter distances at each centerline coordinate. By tracing the centerlines and corresponding diameter distance measurements, a computer-generated model of the three-dimensional lumen can be generated. Grid coordinate data can therefore be used to express three-dimensional space and lumens representing the patient's anatomical structure.

[0191] FIG25 illustrates the relationship between centerline coordinates, diameter measurements, and anatomical space. Fig.25A 2508, 2509, 2510, 2511, 2512, and 2513 represent measurements of lumen 2500 at coordinates 2501, 2502, 2503, 2504, 2505, and 2506.

[0192] exist Fig.25B 2500 can be visualized in three-dimensional space by first locating centerline coordinates 2501, 2502, 2503, 2504, 2505, and 2506 of the three-dimensional space based on centerline 2507. At each centerline coordinate, the lumen diameter can be visualized as a two-dimensional circular space with diameters 2508, 2509, 2510, 2511, 2512, and 2513. By connecting those two-dimensional circular spaces in three dimensions, the lumen 2500 can be approximated as a three-dimensional model 2514. A more accurate approximation can be determined by increasing the resolution and measurement of the centerline coordinates (i.e., increasing the density and measurement of the centerline coordinates) for a given lumen or subsegment. The centerline coordinates can also include markings to indicate points of interest to the physician, including lesions.

[0193] Having expressed and subsequently generated a three-dimensional model of the anatomical space, the pre-operative software package can also be used to analyze and derive the best navigation path based on the generated modules. For example, the software package can derive the shortest path to a single lesion (marked by centerline coordinates) or several lesions. The path can be presented to the operator in two or three dimensions during surgery, depending on the operator's preference.

[0194] Fig.26A computer generated three-dimensional model representing an anatomical space according to an embodiment of the present invention is illustrated. As previously discussed, a model 2600 can be generated using a centerline 2601 obtained by reviewing a CT scan performed preoperatively. In some embodiments, computer software can map an optimal path 2602 of an endoluminal system to enter a surgical site 2603 within the model 2600, and thus enter the corresponding anatomical space. In some embodiments, the surgical site 2603 can be associated with a separate centerline coordinate 2604, which allows a computer algorithm to topologically search for the centerline of the model 2600 of the optimal path 2602 of the endoluminal system.

[0195] Tracking the distal end of an endoscopic tool within the patient's anatomy and mapping that location to placement within a computer model enhances the navigation capabilities of the endoluminal system. To track the distal working end of an endoscopic tool, ie, the "positioning" of the working end, several approaches may be employed alone or in combination.

[0196] In a sensor-based localization approach, a sensor, such as an electromagnetic (EM) tracker, may be coupled to the distal working end of an endoscopic tool to provide a real-time indication of the progress of the endoscopic tool. In EM-based tracking, an EM tracker embedded in an endoscopic tool measures changes in an electromagnetic field generated by one or more static EM transmitters. The transmitter (or field generator) may be placed close to the patient to generate a low-intensity magnetic field. This induces a current in a sensor coil in the EM tracker that is related to the distance and angle between the sensor and the generator. The electrical signal may then be digitized by an interface unit (on-chip or PCB) and sent back to the system cart via cabling / wiring and then to a command module. The data may then be processed to interpret the current data and calculate the precise position and orientation of the sensor relative to the transmitter. Multiple sensors may be used at different locations in the endoscopic device (such as in a guide and sheath) in order to calculate the individual positions of these components. Thus, based on the readings from the artificially generated EM field, the EM tracker may detect changes in field strength as it moves through the patient's anatomy.

[0197] Fig. 27A robotic intracavitary system utilizing an electromagnetic tracker in combination with an electromagnetic field generator is illustrated in accordance with an embodiment of the present invention. When a robotic system 2700 drives a robotically driven endoscopic tool 2701 into a patient 2702, an electromagnetic (EM) tracker 2703 at the distal end of the endoscopic tool 2701 can detect an EM field 2704 generated by the EM field generator. The EM readings of the EM tracker 2703 can be transmitted along the axis of the endoscopic tool 2701 to a system cart 2705 and a command module 2706 (which contains associated software modules, a central processing unit, a data bus, and memory) for interpretation and analysis. Using the readings from the EM tracker 2703, a display module 2707 can display the relative position of the EM tracker within a pre-generated three-dimensional model for review by an operator 2708. Embodiments also provide for the use of other types of sensors (such as fiber optic-shaped sensors). Although a variety of sensors can be used for tracking, the choice of sensors can be inherently limited based on (i) the size of the sensor within the endoscopic tool and (ii) the cost of manufacturing and integrating the sensor into the endoscopic tool.

[0198] Before tracking the sensor through the patient's anatomy, the tracking system may require a process known as "registration," in which the system finds a geometric transformation that aligns a single object between different coordinate systems. For example, a particular anatomical site on a patient has two different representations in CT model coordinates and in EM sensor coordinates. In order to be able to establish consistency and a common language between these coordinate systems, the system needs to find a transformation that relates the two representations (i.e., registration). In other words, the position of the EM tracker relative to the position of the EM field generator can be mapped to a three-dimensional coordinate system to isolate the corresponding position in the three-dimensional model.

[0199] In some embodiments, registration may be performed in several steps. Fig.28 A flow chart for a registration process according to an embodiment of the present invention is illustrated. Initially, in step 2801, the operator must first position the working end of the endoscopic tool at a known starting position. This may involve using video image data from an endoscopic camera to confirm the starting position. Initial positioning can be accomplished by identifying anatomical features with a camera located at the working end of the endoscope. For example, in bronchoscopy, registration can be performed by locating the bottom of the trachea, which is distinguished by locating the two main bronchi for the left and right lungs. The position can be determined using a video image received by a camera in the distal end of the endoscope. In some embodiments, the video data can be compared with different cross-sectional views of a pre-generated computer model of the patient's anatomical structure. By sorting the cross-sectional views, the system can identify the position associated with the cross section with the smallest number of differences or "errors" to find a "match".

[0200] In step 2802, the operator can "drive" or "extend" the endoscope tool into the unique anatomical space that has been mapped. For example, in bronchoscopy, the operator can drive the endoscope from the base of the trachea along a unique bronchial path. Because the base of the trachea divides into two bronchi, the operator can drive the endoscope tool into one tube and track the working end of the endoscope tool using the EM tracker.

[0201] In step 2803, the operator monitors the relative travel of the endoscopic tool. Monitoring of the endoscopic tool can utilize an EM tracker or fluoroscopy to determine the relative motion of the endoscopic tool. The evaluation of the relative displacement of the working end of the endoscopic tool can be compared with a computer model generated by preoperative CT scan data. In some embodiments, the relative motion can be matched with the centerline in the computer model, where the transformation matrix results in the minimum error being the correct registration. In some embodiments, the system and operator can track the insertion data (discussed below) and orientation data from an accelerometer and / or a gyroscope (discussed below).

[0202] In step 2804, the operator may decide to drive into more anatomical spaces (2802) and collect more position information (2803) before comparing and analyzing the position data. For example, in bronchoscopy, the operator retracts the endoscope from one bronchus to a bronchial cannula and drives the endoscope to another bronchial cannula to collect more position data. Once the operator is satisfied, the operator may stop driving (2802) and monitoring the position data (2803), and continue processing the data.

[0203] In step 2805, the system can analyze the collected position data and compare the data to the pre-generated computer model to register the displacement of the endoscope within the patient's anatomy to the model. Thus, by comparing the motion in the patient's anatomy and the three-dimensional model of the patient's anatomy, the system is able to register the tracker with respect to both spaces (three-dimensional computer model vs. patient's anatomical space). After analysis, the registration process may be completed (2806).

[0204] In some cases, it may be necessary to perform a "rolling registration" in order to confirm the orientation of the endoscopic tool. This may be particularly important in step 2801 before driving into an unregistered anatomical space. In bronchoscopy, correct vertical orientation ensures that the operator can distinguish between the right and left bronchus. For example, within the base of the trachea, images of the left and right bronchus may appear very similar regardless of whether the camera is oriented at zero or 180 degrees. Rolling registration may also be important because the movement of the endoscopic tool often results in slight rotations during tortuous navigation within the patient.

[0205] Roll registration may be important at the surgical site when the working channel may be occupied by the sensor. For example, in embodiments with only a single working channel, upon reaching the surgical site, the physician may need to remove the EM tracker from an endoscopic tool in order to use another tool, such as a grasper or forceps. However, after removal, the system may lose its localization capabilities without the EM tracker. Therefore, when preparing to leave the surgical area, insertion of the EM tracker may require that roll registration be performed again to ensure proper orientation.

[0206] In some embodiments, the rotation of the endoscopic tool can be tracked using an accelerometer mounted within the distal working end of the device. Using an accelerometer to detect the force of gravity on the endoscope provides information about the position of the endoscopic tool relative to the ground. The position of the ground relative to the endoscope can be used to resolve certain ambiguities. In bronchoscopy, for example, knowing the orientation of the distal camera of the endoscope (0 degrees or 180 degrees) may help to determine the appropriate bronchial branch at the beginning. During navigation, data from the accelerometer used to track the direction of gravity and therefore the orientation can also be used to automatically correct the camera image displayed on the console, thereby ensuring that the displayed image is always oriented vertically.

[0207] In a preferred embodiment, a 3-axis MEMS-based sensor chip with an accelerometer can be coupled on the same printed circuit board as the digital camera near the tip of the endoscopic device. The accelerometer measures linear acceleration along three different axes to calculate the velocity and direction of the catheter tip. The accelerometer also measures the direction of gravity, thus providing absolute information about the orientation of the endoscopic device. The accelerometer readings are retransmitted using digital or analog signals via a communication protocol like I2C. The signal can be transmitted to the proximal end of the catheter through wiring, and from there to the system cart and command module for processing.

[0208] In a three-axis sensor, an accelerometer can determine the position of the ground relative to the endoscope. A two-axis accelerometer may also be useful if the endoscope does not roll or bend up to ninety degrees. Alternatively, a one-axis sensor may be useful if the axis of the accelerometer is held perpendicular to the direction of gravity (i.e., perpendicular to the ground). Alternatively, a gyroscope may be used to measure the rotational velocity, which may then be used to calculate the articulation of the endoscopic device.

[0209] Some embodiments use an EM tracker in combination with an accelerometer to supplement any orientation readings from the accelerometer. In some embodiments, the use of fluoroscopy to track the endoscopic tool can also supplement the registration process. As is known in the art, fluoroscopy is an imaging technique that uses X-rays to obtain real-time moving images of a patient's internal structures through the use of a fluoroscope. The two-dimensional scan generated by fluoroscopy can help locate in some cases, for example, to identify the relevant bronchus.

[0210] Tracking using fluoroscopy can be performed using multiple radiopaque markers on the endoscope. Many features of the endoscope are naturally opaque to x-rays, including the camera head, control rings, and pull wires; therefore, the marker locations, along with the metal parts of the endoscope, can be used to obtain a three-dimensional transformation matrix. Once registration has occurred, the visual image of the detected branch locations can be accurately correlated to the three-dimensional model. In addition, full branch lengths and branch locations in 3D can be measured and enhanced in the map.

[0211] In contrast to sensor-based approaches, vision-based tracking involves using images generated by a distally mounted camera to determine the position of endoscopic tools. For example, in bronchoscopy, feature tracking algorithms can be used to identify circular geometries corresponding to bronchial pathways and track changes in these geometries from image to image. By tracking the orientation of these features as they move from image to image, the system is able to determine which branch to select, as well as the relative rotational and translational motion of the camera. The use of topological maps of bronchial pathways can further enhance vision-based algorithms.

[0212] In addition to feature-based tracking, image processing techniques such as optical flow can also be used to identify branches of airway topology in bronchoscopy. Optical flow is the displacement of image pixels in a video sequence from one image to the next. With respect to bronchoscopy, optical flow can be used to estimate the motion of the tip of the endoscope based on changes in the camera image received at the tip of the endoscope. Specifically, in a series of video frames, each frame can be analyzed to detect the translation of pixels from one frame to the next. For example, if a pixel in a given frame appears to have translated to the left in the next frame, the algorithm will infer that the camera, and in turn the tip of the endoscope, has moved to the right. By comparing many frames over many iterations, the motion (and therefore, position) of the endoscope can be determined.

[0213] Where stereoscopic image capture (as opposed to monocular image capture) is available, optical flow techniques can also be used to supplement pre-existing three-dimensional models of anatomical regions. Using stereoscopic image capture, the depth of pixels in the two-dimensional captured images can be determined to build a three-dimensional map of objects in the camera view. Extrapolated to travel within the anatomical lumen, the technique enables the system to develop a three-dimensional map of the local environment surrounding the endoscope while navigating within the patient's anatomy. These maps can be used to extend pre-determined three-dimensional computer models where the model is either missing data or of low quality. In addition to a stereo camera setup, the use of a depth sensor or specific lighting configurations and image capture techniques (such as RGB-D sensors or structured lighting) may be required.

[0214] Regardless of whether the tracking method is sensor-based or vision-based, tracking can still be improved by using data from the endoscopic tool itself. For example, in the endoscopic tool 200 of Figure 2, the relative insertion lengths of the sheath 201 and guide 205 can be measured from a known starting position within the trachea (in the case of bronchoscopy). Using the relative insertion lengths and the centerline of a three-dimensional model of the patient's bronchial tree, the system can give a rough estimate of the position of the working end after determining whether the endoscopic tool is located in a branch and the distance to travel along the branch. Other control information from the endoscopic tool can also be used, such as the articulation, roll, or pitch and yaw of the endoscopic device.

[0215] Real-time imaging based on different imaging modalities may further enhance navigation, especially at the surgical site. Even though tracking can assist in rough navigation to the surgical site, additional modalities may be useful when more precise processing is necessary (such as when attempting to biopsy a lesion). Imaging tools (such as fluorescence imaging, near-infrared imaging, oxygen sensors, molecular biomarker images, and contrast dye imaging) can help pinpoint the exact coordinates of the lesion in the computer model and therefore assist in manipulating the biopsy needle at the surgical site. In the absence of a precise location, endoscopic tools can be used to biopsy the entire area of ​​the surgical site at a known depth, thus ensuring that tissue from the lesion is sampled.

[0216] In some cases, segmented CT scans, and therefore the resulting computer models, do not show branches at the periphery of the lung (in the context of bronchoscopy). This may be due to underinflation of the airways during the scan, or because the size of the branches is below the resolution of the CT scan (usually on the order of 1 mm). In practice, the robotic system can enhance the computer model during the procedure by pointing out the location and position and orientation of unmapped branches. In some embodiments, the topology can allow the physician to mark their location and return to the same location in order to examine peripheral branches. In some embodiments, the endoscopic camera can measure the diameter and shape of the branches based on the captured images, allowing those branches to be mapped based on location and orientation.

[0217] 10. Intracavitary procedures

[0218] Fig.29A The distal end of an endoscopic tool within an anatomical lumen is illustrated in accordance with an embodiment of the present invention. Fig.29A , an endoscopic tool 2900 including a shaft 2901 is shown being navigated through an anatomical lumen 2902 toward a surgical site 2903. During navigation, the shaft 2901 may not be articulated.

[0219] Fig.29B Diagram showing the use of Fig.29A A distal guide segment 2904 that has reached the surgical site 2903 and is longitudinally aligned with the shaft 2901 may extend from the shaft 2901 in the direction marked by arrow 2905. The distal guide segment 2904 may also be articulated to guide the tool toward the surgical site 2903.

[0220] Fig.29C Illustration of the use of surgical sites within anatomical lumens Fig.29B In the event that the surgical site contains a biopsy lesion, the distal guide segment 2904 can be articulated in the direction marked by arrow 2906 to deliver the aspiration needle 2907 to target the lesion at the surgical site 2903. In some embodiments, the distal guide segment 2904 can be articulated to guide the biopsy forceps to remove a dissected tissue sample for the purpose of intraoperative evaluation. For the purpose of activating the end effector, the endoscopic tool 2900 can include a tendon operably coupled to the biopsy forceps.

[0221] Fig. 30A An endoscopic tool is illustrated coupled to a distal curved section within an anatomical lumen according to an embodiment of the present invention. Fig. 30A , an endoscopic tool 3000 including a shaft 3001, a curved section 3002, and forceps 3003 is shown navigating through an anatomical lumen 3004 toward a surgical site. During navigation, as shown in FIG. Fig. 30AAs shown, the shaft 3001 and the distal curved segment 3002 may not be articulated. In some embodiments, the curved segment 3002 may be retracted within the shaft 3001. The construction, composition, capabilities, and use of the curved segment 3002 are disclosed in U.S. Patent Application No. 14 / 201,610 filed on March 7, 2014 and U.S. Patent Application No. 14 / 479,095 filed on September 5, 2014, the entire contents of which are incorporated herein by reference.

[0222] In some embodiments, the curved segment 3002 can be longitudinally aligned with the shaft 3001. In some embodiments, the curved segment 3002 can be deployed through a working channel that is offset from the axis (neutral axis) of the shaft 3001, thereby allowing the curved segment 3002 to be manipulated without obscuring a camera located at the distal end of the shaft 3001. This arrangement allows the operator to articulate the curved segment 3002 using the camera while the shaft 3001 remains stationary.

[0223] Similar to other embodiments, different tools, such as forceps 3003, can be deployed through the working channel in the curved segment 3002 for use at the distal end of the curved segment 3002. In other scenarios, surgical tools, such as graspers, scalpels, needles, and probes can be located at the distal end of the curved segment 3002. In the endoscopic tool 3000, as in other embodiments, the tools at the distal end of the curved segment can be replaced intraoperatively to perform multiple treatments in a single procedure.

[0224] Fig. 30B FIG. 1 illustrates a surgical device having a forceps tool used at a surgical site within an anatomical lumen according to an embodiment of the present invention. Fig. 30A Endoscopic tool 3000 may be navigated through anatomical lumen 3004 as directed by any number of the various navigation techniques discussed above. Once endoscopy tool 3000 has reached its desired position at surgical site 3006, curved segment 3002 may be articulated in the direction of arrow 3005 to position forceps 3003 toward surgical site 3006. Using forceps 3003, endoscopy tool 3000 may perform a tissue biopsy at surgical site 3006.

[0225] Fig. 30C FIG. 1 illustrates a laser device used at a surgical site within an anatomical lumen according to an embodiment of the present invention. Fig. 30A The curved section 3002 of the endoscopic tool 3000 that has reached the surgical site 3006 can be articulated and the laser tool 3007 can be deployed through the working channel of the shaft 3001 and the curved section 3002. Once deployed, the laser tool 3007 can be directed to the surgical site 3006 to emit laser radiation 3008 for the purpose of tissue ablation, drilling, cutting, perforation, debridement, cutting, or access to non-superficial tissue.

[0226] 11. Command Console

[0227] As reference Figure 1 As discussed above with respect to system 100 of the present invention, embodiments of the command console allow an operator (i.e., a physician) to remotely control a robotic endoluminal system from an ergonomic position. In a preferred embodiment, the command console utilizes a user interface that (i) enables the operator to control robotic endoscopic tools and (ii) displays a navigation environment from an ergonomic position.

[0228] Fig.31 FIG. 1 is a diagram illustrating a command console for a robotic intracavitary system according to an embodiment of the present invention. Fig.31 As shown, command console 3100 may include base 3101, display module (e.g., monitor 3102), and control module (such as keyboard 3103 and joystick 3104). In some embodiments, command module functionality may be integrated into a system cart having a robotic arm, such as from Figure 1 A system cart 101 of the system 100 .

[0229] The base 3101 may include a central processing unit, a memory unit, a data bus, and associated data communication ports responsible for interpreting and processing signals from the endoscopic tools (such as camera images and tracking sensor data). In other embodiments, the burden of interpreting and processing signals may be distributed between an associated system cart and the command console 3100. The base 3101 may also be responsible for interpreting and processing commands and instructions from an operator 3105 through control modules (such as 3103 and 3104).

[0230] The control module is responsible for capturing the commands of the operator 3105. Fig.31 In addition to the keyboard 3103 and joystick 3104 in the control module, the control module may include other control mechanisms known in the art, including but not limited to computer mice, touch pads, trackballs, control pads, and video game controllers. In some embodiments, hand gestures and finger gestures may also be captured to deliver control signals to the system.

[0231] In some embodiments, there may be multiple control devices. For example, control of the endoscopic tool can be performed in a "speed mode" or a "position control mode". The "speed mode" consists of directly controlling the pitch and yaw behavior of the distal end of the endoscopic tool based on direct manual control (such as through the joystick 3104). For example, right and left movements on the joystick 3104 can be mapped to yaw and pitch movements of the distal end of the endoscopic tool. Tactile feedback of the joystick can also be used to enhance control in "speed mode". For example, vibrations can be sent back to the joystick 3104 to communicate that the endoscopic tool cannot be further articulated or rolled in a certain direction. Alternatively, pop-up messages and / or audio feedback (e.g., a beep) can also be used to communicate that the endoscopic tool has reached maximum articulation or rolling.

[0232] The "position control mode" consists of identifying the patient's position in a three-dimensional map and relying on the robotic system to robotically steer the endoscopic tool based on a predetermined computer model. Because it relies on a three-dimensional map of the patient, the position control mode requires an accurate mapping of the patient's anatomy.

[0233] The system can also be manipulated directly by a human operator without the use of command module 3101. For example, during system setup, a physician and assistant can move the robotic arms and endoscopic tools to position the equipment around the patient and operating room. During direct manipulation, the system can rely on force feedback and inertial control from the human operator to determine appropriate equipment orientation.

[0234] The display module 3102 may include a monitor, a virtual reality viewing device (such as goggles or glasses), or other devices that display visual information about the system and from a camera (if any) in the endoscope tool. In some embodiments, the control module and the display module may be combined, such as in a touch screen in a tablet or computer device. In the combined module, the operator 3105 is able to view visual data and input commands to the robotic system.

[0235] In another embodiment, the display module can display a three-dimensional image using a stereoscopic device (such as a visor or goggle arrangement). Using the three-dimensional image, the operator can view an "endo view" of the computer model, a virtual environment inside a three-dimensional computer-generated model of the patient's anatomy to approximate the expected position of the device within the patient. By comparing the "endo view" with the actual camera image, the physician can mentally orient himself and confirm that the endoscopic tool is in the correct position within the patient's body. This can allow the operator to better perceive the anatomical structures around the distal end of the endoscopic tool.

[0236] In a preferred embodiment, the display module 3102 can simultaneously display a pre-generated three-dimensional model, a predetermined optimal navigation path through the model, and a CT scan of the anatomical structure at the current position of the distal end of the endoscopic tool. In some embodiments, the model of the endoscopic tool can be displayed along with the three-dimensional model of the patient's anatomy to further clarify the status of the procedure. For example, a lesion may have been identified in a CT scan where a biopsy may be necessary.

[0237] During surgery, the camera device and lighting device at the distal end of the endoscopic tool can generate a reference image in the display module for the operator. Therefore, the direction in the joystick 3104 that causes the articulation and rolling of the distal end of the endoscopic tool produces an image of the anatomical features directly in front of the distal end. The joystick 3104 tip pointing up may cause the distal end of the endoscopic tool with the camera to pitch, while the joystick 3104 tip pointing down may reduce the pitch.

[0238] The display module 3102 can automatically display different views of the endoscopic tool according to the operator settings and the specific process. For example, if necessary, when the intracavitary device approaches the surgical field, a top view fluorescent view of the intracavitary device can be displayed during the last navigation step.

[0239] The elements or parts shown using any embodiment herein are exemplary for a particular embodiment and may be used in other embodiments disclosed herein or in combination with other embodiments disclosed herein. Although the present invention allows various modifications and alternative forms, its specific examples have been shown in the accompanying drawings and are described in detail herein. However, the present invention is not limited to the disclosed specific forms or methods, but on the contrary, covers all modifications, equivalents and substitutes thereof.

Claims

1. A device for a robotic medical system, comprising: Instrument manipulators, including: Drive unit; A strain gauge is longitudinally parallel to the driving unit; and Motor mounting parts, wherein the strain gauge is coupled to the drive unit via the motor mount, wherein the drive unit is configured to apply a force to the pull wire, and the strain gauge is oriented in a first direction transverse to a path of the pull wire, and The strain gauge is configured to measure a displacement of at least a portion of the drive unit along a second direction that is the same as the path of the pull wire, the measured displacement of the drive unit being responsive to the force applied to the pull wire. 2 . The device according to claim 1 , wherein the driving unit comprises a motor, a gear head and a rotary encoder.

3. The device according to claim 1, further comprising: Endoscopic tools, including: a shaft having a distal portion and a proximal portion; an instrument base coupled to the proximal portion of the shaft, the instrument base containing a chamber containing a winding wheel configured to rotate within the chamber, The winding wheel is not fixedly coupled to the chamber, and the drive unit is configured to twist the winding wheel.

4. The apparatus of claim 3, wherein the reel is configured to transmit force from the drive unit to the pull wire.

5. The apparatus of claim 4, wherein a portion of the pull line is wound around the winding wheel. The apparatus according to claim 3 , wherein the endoscopic tool is detachable from the drive unit.

7. The apparatus of claim 3, wherein the instrument base is configured to be positively coupled to the drive unit.

8. The apparatus of claim 1, wherein: The driving unit includes a first end and a second end opposite to each other in the first direction, The strain gauge includes a first end and a second end opposite to each other in the first direction, The motor mount couples a first end of the drive unit to a first end of the strain gauge, and The instrument manipulator also includes: A strain gauge mounting couples the second end of the drive unit to the second end of the strain gauge.

9. The apparatus of claim 8, wherein the strain gauge is further configured to measure displacement of the motor mount relative to the strain gauge mount in the second direction.

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