Systems and methods for modular endoscope

Abstract

An articulated flexible endoscope is provided. The endoscope comprises: a distal tip portion manipulated via a drive mechanism; a curved section connected at a first end to the distal tip portion and connected at a transition interface to the shaft portion, the curved section being hinged by one or more pull wires; and a shaft portion including one or more load transfer tubes anchored to the transition interface and having a length greater than the length of the shaft portion for reducing at least a portion of the articulation force applied to the curved section by the one or more pull wires, thereby improving the stability of the shaft portion.

Description

[0001] This application is a divisional application of the Chinese patent application with the application date of December 18, 2020, application number 202080097107.6, and invention name “Systems and methods for modular endoscopes” (the corresponding PCT application with the application date of December 18, 2020 and application number PCT / US2020 / 066030).

[0002] References

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 950,740 filed on December 19, 2019 and U.S. Provisional Patent Application No. 63 / 091,268 filed on October 13, 2020, the entire contents of each of which are incorporated herein by reference. Background Art

[0004] Endoscopy procedures use an endoscope to examine the interior of a hollow organ or cavity of the body. Unlike many other medical imaging techniques, endoscopes are inserted directly into the organ. Flexible endoscopes, which can deliver instinctive manipulation and control, are useful for diagnosing and treating diseases that are accessed through any natural orifice of the body. Depending on the clinical indication, endoscopes can be designated as bronchoscopes, ureteroscopes, colonoscopes, gastroscopes, otolaryngoscopes, and various others. For example, flexible endoscopy has been used to examine and treat gastrointestinal (GI) disorders without creating an opening in the patient's body. The endoscope is introduced into the upper or lower digestive tract through the mouth or anus, respectively. A miniature camera at the distal end captures images of the GI wall, helping clinicians diagnose GI diseases. Simple surgical procedures (such as polypectomy and biopsy) can be performed by introducing flexible tools through the working channel to reach the distal site of interest.

[0005] Endoscopes are conventionally made to be reusable, which may require thorough cleaning, disinfection and / or sterilization after each procedure. In most cases, cleaning, disinfection and sterilization may be an active process that kills germs and / or bacteria. Such procedures may also be harsh on the endoscope itself. Therefore, the design of such reusable endoscopes is often complex, especially to ensure that the endoscope can withstand such harsh cleaning, disinfection and sterilization regimens. Such reusable endoscopes may often require regular maintenance and repair.

[0006] Low-cost, disposable medical devices designated as single-use have become popular for instruments that are difficult to properly clean. Single-use, disposable devices can be packaged in sterile packaging to avoid the risk of pathogenic cross-contamination of diseases such as HIV, hepatitis, and other pathogens. Hospitals generally welcome the convenience of single-use products because they no longer need to worry about aging, overuse, breakage, malfunction, and sterilization of the product. Conventional endoscopes typically include a handle that the operator uses to manipulate the endoscope. For single-use endoscopes, the handle typically houses a camera, expensive electronics, and mechanical structures at the proximal end to transmit video and allow the user to manipulate the endoscope via a user interface. This can result in a high cost for single-use endoscope handles. Summary of the invention

[0007] It is recognized herein that there is a need for an endoscope that allows surgical or diagnostic operations to be performed with improved performance and cost-effectiveness. It is also recognized herein that devices and systems including endoscopes can be disposable and may not require a large amount of clean surgery. The present disclosure provides low-cost, disposable, articulated endoscopes for diagnosis and treatment in various applications, such as bronchoscopy, urology, gynecology, articulated endoscopy, orthopedics, otolaryngology, gastrointestinal endoscopy, neurosurgery, and various other applications. It should be noted that the endoscopic system provided can be used for various minimally invasive surgical, therapeutic or diagnostic procedures involving various types of tissues, including heart, bladder, and lung tissue, as well as other anatomical regions of the patient's body, such as the digestive system, including but not limited to the esophagus, liver, stomach, colon, urinary tract, or respiratory system, including but not limited to the bronchi, lungs, and various other systems.

[0008] It should be noted that the various components of the provided modular endoscopic components and devices can be used in various minimally invasive surgical procedures, therapeutic or diagnostic procedures involving various tissue types including heart, bladder and lung tissue, as well as other anatomical regions of a patient's body, such as the digestive system, including but not limited to the esophagus, liver, stomach, colon, urinary tract or the respiratory system, including but not limited to the bronchi, lungs and various other systems.

[0009] In one aspect, an articulating flexible endoscope is provided herein. The articulating flexible endoscope comprises: a distal tip portion that is steerable via a drive mechanism; a bending section that is connected to the distal tip portion at a first end and to a shaft portion at a transition interface, wherein the bending section is articulated by one or more pull wires; and the shaft portion comprises one or more load transmission tubes for accommodating one or more pull wires, thereby improving the stability of the shaft portion.

[0010] In some embodiments, the distal tip portion includes a structure for receiving an imaging device, a position sensor, and an illumination device. In some embodiments, each of the one or more pull wires is placed within the inner cavity of each of the one or more load transfer tubes. In some embodiments, the curved segment is bent in two or more directions by one or more pull wires. In some embodiments, one or more load transfer tubes are anchored to the transition interface and have a length greater than the length of the shaft portion. In some embodiments, one or more load transfer tubes have a nonlinear configuration. In some embodiments, one or more load transfer tubes have a spiral configuration.

[0011] In some embodiments, the shaft portion includes a tube having an integrally formed structure to change the stiffness of the shaft portion. In some embodiments, the articulated flexible endoscope also includes a deformable working channel. In some embodiments, the articulated flexible endoscope also includes a handle portion, wherein the handle portion includes one or more components that are configured to process image data, provide power to one or more electronic components located at the distal tip portion, or establish communication with an external device. In some cases, the handle portion includes an interface configured to couple the handle portion to an instrument drive mechanism. In some cases, the interface is an electrical interface and a mechanical interface. In some cases, the handle portion includes a mechanical control module for connecting a flushing system or a suction system.

[0012] In another aspect, a disposable endoscope is provided herein. The disposable endoscope includes: a distal tip portion including an imaging device, a position sensor, and an illumination device; a bending section connected to the distal tip portion at a first end and connected to a shaft portion at a second end, wherein the bending section is articulated by one or more pull wires; and a shaft portion including one or more load transmission tubes for accommodating one or more pull wires to improve the stability of the shaft portion.

[0013] In some embodiments, the distal tip portion includes structure for receiving an imaging device, a position sensor, and an illumination device. In some embodiments, the imaging device, the position sensor, and the illumination device are arranged in a compact configuration. In some embodiments, one or more load transmission tubes have a length greater than the length of the shaft portion.

[0014] In some embodiments, each of the one or more pull wires is placed within the lumen of a respective load transfer tube of the one or more load transfer tubes. In some embodiments, the one or more pull wires are movable relative to the one or more load transfer tubes. In some embodiments, the curved segment is bent in two or more directions by the one or more pull wires. In some embodiments, the one or more load transfer tubes have a non-linear configuration. In some embodiments, the one or more load transfer tubes have a spiral configuration.

[0015] In some embodiments, the shaft portion includes a tube having an integrally molded structure to change the stiffness of the shaft portion. In some embodiments, the disposable endoscope also includes a deformable working channel. In some embodiments, the disposable endoscope also includes a handle portion, wherein the handle portion includes one or more components that are configured to process image data, provide power to imaging devices, position sensors, and lighting devices, or establish communication with external devices. In some cases, the handle portion includes an interface configured to couple the handle portion to an instrument drive mechanism. In some cases, the interface includes an electrical interface and a mechanical interface. In some examples, the mechanical interface is configured to releasably couple the handle portion to the instrument drive mechanism.

[0016] Other aspects and advantages of the present disclosure will become readily apparent to those skilled in the art through the following detailed description, wherein only illustrative embodiments of the present disclosure are shown and described. As will be appreciated, the present disclosure is capable of other and different embodiments, and its several details are capable of being modified in various obvious aspects, all without departing from the present disclosure. Therefore, the drawings and descriptions are to be considered illustrative in nature, rather than restrictive.

[0017] Incorporation by reference

[0018] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. To the extent that publications and patents or patent applications incorporated by reference conflict with the disclosure contained in the specification, the specification is intended to supersede and / or take precedence over any such conflicting material. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The novel features of the present invention are particularly set forth in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description of illustrative embodiments in which the principles of the present invention are utilized and the accompanying drawings (also referred to herein as "drawings" and "figures"), in which:

[0020] Figure 1 An example of a flexible endoscope according to some embodiments of the present disclosure is shown.

[0021] Figure 2 An example of an endoscope having an articulating force transmission mechanism according to some embodiments of the present invention is shown.

[0022] Figure 3A and Figure 3B An example of one or more pull wires assembled with one or more load transfer tubes in a curved section is shown.

[0023] Figure 4 An example of a load transmission tube terminating at a distal shaft region and a proximal shaft region is shown.

[0024] Figure 5 An example of a load transmission tube terminating at a distal shaft region and a proximal shaft region is shown.

[0025] Figure 6 Examples of existing steerable catheter structures are shown.

[0026] Figure 7 An example of an insert shaft design is shown.

[0027] Figure 8 An example of a robotic bronchoscope according to some embodiments of the present invention is shown.

[0028] Fig. 9 An example of an instrument drive mechanism providing a mechanical interface for a handle portion of a robotic bronchoscope according to some embodiments of the present invention is shown.

[0029] Fig.10 An example of a handle portion of a robotic bronchoscope according to some embodiments of the present invention is shown.

[0030] Fig.11 An example of a steerable catheter according to some embodiments of the present invention is shown.

[0031] Fig.12 An example of a distal portion of a catheter with integrated imaging and lighting devices is shown.

[0032] Fig.13 An example of a compact configuration of multiple electronic components disposed in a distal portion of a catheter according to some embodiments of the present invention is shown.

[0033] Fig.14 Examples of conventional configurations and novel configurations of the present disclosure are shown for pull wires attached to a control loop structure.

[0034] Fig.15 Various configurations of puller wires for use with a robotic catheter system according to some embodiments of the present invention are shown.

[0035] Fig.16 An example of a guidewire with an inflatable tip according to some embodiments of the present invention is shown.

[0036] Fig.17 Examples of endoscope tip designs are shown. DETAILED DESCRIPTION

[0037] Although various embodiments of the present invention have been shown and described herein, it is readily understood by those skilled in the art that these embodiments are provided as examples only. Without departing from the present invention, those skilled in the art may conceive of many variations, changes and substitutions. It should be understood that various alternatives to the embodiments of the present invention described herein may be employed.

[0038] The embodiments disclosed herein can be combined in one or more of a variety of ways to provide improved diagnosis and treatment to patients. The disclosed embodiments can be combined with existing methods and devices to provide improved treatment, such as combined with known methods of lung diagnosis, surgery, and surgery of other tissues and organs. It should be understood that any one or more structures and steps described herein can be combined with any one or more additional structures and steps of the methods and devices described herein, and the drawings and supporting text provide descriptions according to the embodiments.

[0039] Although the exemplary embodiments will be primarily directed to devices or systems for bronchoscopy, those skilled in the art will appreciate that this is not intended to be limiting and that the devices described herein may be used in other therapeutic or diagnostic procedures and in various anatomical regions of a patient's body. The provided devices or systems may be used in urology, gynecology, rhinology, otology, laryngoscopy, gastroenterology and endoscopy, combined devices including endoscopes and instruments, endoscopes with positioning capabilities, and those skilled in the art will appreciate that this is not intended to be limiting and that the devices described herein may be used in other therapeutic or diagnostic procedures and in various anatomical regions of a patient's body, such as the brain, heart, lungs, intestines, eyes, skin, kidneys, liver, pancreas, stomach, uterus, ovaries, testicles, bladder, ears, nose, mouth, soft tissue such as bone marrow, adipose tissue, muscle, glandular and mucosal tissue, nerve tissue, cartilage, and spine. , hard biological tissues such as teeth, bones, etc., and body cavities and passages such as sinuses, ureters, colon, esophagus, lung passages, blood vessels and throat, and various other tissues, in the form of: neuroendoscopes, encephaloscopes, ophthalmoscopes, otoscopes, nasal endoscopes, laryngoscopes, gastroscopes, esophagoscopes, bronchoscopes, thoracoscopic, pleural scopes, angioscopes, mediastinoscopes, nephroscopes, gastroscopic, duodenoscopes, choledochoscopes, bile ductoscopes, laparoscopes, amine scopes, ureteroscopes, hysteroscopes, cystoscopes, proctoscopic, colonoscopes, articulated (endoscopes), sialendoscopic, orthopedic endoscopes and other forms, combined with various tools or instruments.

[0040] The systems and devices herein can be combined in one or more of a variety of ways to provide improved diagnosis and treatment to patients. The systems and devices provided herein can be combined with existing methods and devices to provide improved treatment, such as in combination with known lung diagnosis, surgical procedures, and surgical procedures of other tissues and organs. It should be understood that any one or more of the structures and steps described herein can be combined with any one or more additional structures and steps of the methods and devices described herein, and the accompanying drawings and supporting text provide descriptions according to the embodiments.

[0041] Whenever the term "at least", "greater than", or "greater than or equal to" precedes the first value in a series of two or more values, the term "at least", "greater than", or "greater than or equal to" applies to each value in the series. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.

[0042] Whenever the term "not greater than," "less than," or "less than or equal to" precedes the first value in a series of two or more values, the term "not greater than," "less than," or "less than or equal to" applies to every value in the series. For example, less than or equal to 3, 2, or 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.

[0043] As used herein, the terms distal and proximal may generally refer to a position referenced from an instrument and may be in contrast to an anatomical reference. For example, a distal position of a main shaft or catheter may correspond to a proximal position of an elongated member of a patient, and a proximal position of a main sheath or catheter may correspond to a distal position of an elongated member of a patient.

[0044] Modular Flexible Endoscope

[0045] In one aspect of the present invention, a flexible endoscope with improved performance and reduced cost is provided. Figure 1 An example of a flexible endoscope 100 according to some embodiments of the present disclosure is shown. Figure 1As shown, the flexible endoscope 100 may include a handle portion 109 and a flexible elongated member to be inserted into the interior of the object. In some embodiments, the flexible elongated member may include an axis (e.g., an insertion axis 101), a manipulable tip (e.g., a tip 105) and a manipulable portion (bend segment 103). Endoscope 100 may also be referred to as a manipulable catheter assembly as described elsewhere herein. In some cases, endoscope 100 may be a disposable robotic endoscope. In some cases, the entire catheter assembly may be disposable. In some cases, at least a portion of the catheter assembly may be disposable. In some cases, the entire endoscope may be released from the instrument drive mechanism and may be discarded. In some embodiments, the endoscope may include different degrees of stiffness along the axis to improve functional operation.

[0046] Endoscope or steerable catheter assembly 100 can include handle portion 109, and this handle portion 109 can include one or more parts configured to process image data, provide electric power or set up other external equipment communication.For example, handle portion can include circuit and communication element, and it can electrically communicate between steerable catheter assembly 100 and instrument drive mechanism (not shown) and any other external system or equipment.In another example, handle portion 109 can include circuit element, such as the power supply for the electronic equipment (for example, camera, electromagnetic sensor and LED lamp) of endoscope to power.

[0047] One or more components located at the handle can be optimized so that expensive and complex components can be allocated to the robotic support system, handheld controller, or instrument drive mechanism, thereby reducing costs and simplifying the design of the disposable endoscope. In some cases, the handle portion can be connected to the instrument drive mechanism (e.g., a printed circuit board) via an electrical interface (e.g., a printed circuit board). Figure 8 , instrument drive mechanism 820) is electrically connected so that image / video data and / or sensor data can be received by the communication module of the instrument drive mechanism and can be transmitted to other external devices / systems. In some cases, the electrical interface can establish electrical communication without cables or wires. For example, the interface can include pins soldered to an electronic board such as a printed circuit board (PCB). For example, a socket connector (e.g., a female connector) is provided on the instrument drive mechanism as a mating interface. This can advantageously allow the endoscope to be quickly inserted into the instrument drive mechanism or the robot support without the need for additional cables. This type of electrical interface can also be used as a mechanical interface so that when the handle portion is inserted into the instrument drive mechanism, both mechanical and electrical coupling are established. Alternatively or additionally, the instrument drive mechanism can provide only a mechanical interface. The handle portion can be in electrical communication with a modular wireless communication device or any other user device (e.g., a portable / handheld device or a controller) for transmitting sensor data and / or receiving control signals.

[0048] In some cases, the handle portion 109 may include one or more mechanical control modules, such as a Luer connector 111 for docking an irrigation system / aspiration system. In some cases, the handle portion may include a lever / knob for articulation control. Alternatively, the articulation control may be located at a separate controller attached to the handle portion via the instrument drive mechanism.

[0049] The endoscope can be attached to a robot support system or a handheld controller via an instrument drive mechanism. The instrument drive mechanism can be provided by any suitable controller device (e.g., a handheld controller) that may or may not include a robot system. The instrument drive mechanism can provide a mechanical and electrical interface for the steerable catheter assembly 100. The mechanical interface can allow the steerable catheter assembly 100 to be releasably coupled to the instrument drive mechanism. For example, the handle portion of the steerable catheter assembly can be attached to the instrument drive mechanism via a quick installation / release tool (such as a magnet, a spring-loaded level, etc.). In some cases, the steerable catheter assembly can be manually coupled to the instrument drive mechanism or released from the instrument drive mechanism without using a tool. The details about the instrument drive mechanism will be described later herein.

[0050] In the example shown, the distal tip of the catheter or endoscope shaft is configured to articulate / bend with two or more degrees of freedom to provide a desired camera view or control the direction of the endoscope. As shown in the example, an imaging device (e.g., a camera), a position sensor (e.g., an electromagnetic sensor) 107 is located at the tip of the catheter or endoscope shaft 105. For example, the line of sight of the camera can be controlled by controlling the articulation of the curved segment 103. In some cases, the angle of the camera can be adjustable so that the line of sight can be adjusted without articulating the distal tip of the catheter or endoscope shaft or in addition to articulating the distal tip of the catheter or endoscope shaft. For example, the camera can be oriented at a certain angle (e.g., tilted) with respect to the axial direction of the endoscope tip with the help of the best component.

[0051] The distal tip 105 may be a rigid component that allows for positioning of sensors, such as electromagnetic (EM) sensors, imaging devices (eg, cameras), and other electronic components (eg, LED light sources) embedded at the distal tip.

[0052] In real-time EM tracking, an EM sensor comprising one or more sensor coils is embedded in one or more positions and orientations in a medical instrument (e.g., the tip of an endoscopic tool) to measure changes in the EM field generated by one or more static EM field generators positioned near the patient. The position information detected by the EM sensor is stored as EM data. An EM field generator (or transmitter) can be placed near the patient to generate a low-intensity magnetic field that can be detected by the embedded sensor. The magnetic field induces a small current in the sensor coil of the EM sensor, which can be analyzed to determine the distance and angle between the EM sensor and the EM field generator. For example, an EM field generator can be positioned near the patient's torso during surgery to locate the EM sensor position in 3D space, or the EM sensor position and orientation can be located in 5D or 6D space. This can provide a visual guide for the operator when driving the bronchoscope toward the target site. Details of the tip design and multiple components embedded in the tip will be described later in this article.

[0053] The endoscope may have a unique design in the shaft component. In some cases, the insertion shaft of the endoscope may be composed of a single tube that contains a series of cutouts (e.g., reliefs, slits, etc.) along its length to allow for increased flexibility as well as desired stiffness. Details of the shaft design will be described later in this article.

[0054] The curved segment 103 can be designed to allow bending in two or more degrees of freedom (e.g., articulation). The unique structure of the curved segment can achieve greater curvature, such as 180 degrees and 270 degrees (or other articulation parameters for clinical indications). In some cases, the curved segment can be independently manufactured as modular components and assembled to the insertion shaft. In some cases, the curved segment can further incorporate minimalist features to reduce cost and increase reliability. For example, the curved segment can incorporate an engraved pattern that advantageously allows a greater degree of tube deformation to achieve a desired tip displacement relative to the insertion shaft.

[0055] In some embodiments, the bending section or endoscope may include an articulating force transmission mechanism to ensure endoscope stability and deliver instinctive bending section responsiveness. Figure 2 An example of an endoscope with an articulation force transmission mechanism 201 according to some embodiments of the present invention is shown. The articulation force transmission mechanism 201 may include a plurality of load transmission tubes located within a bore of an insertion shaft / tube. In some cases, at least one, two, three, four, five, or more load transmission tubes may be included to reduce axial compression / extension (tensioning) of the insertion tube 203 during articulation of the bending segment. The load transmission tubes may transmit at least a portion of the articulation load applied to the bending segment and / or shaft back to the handle (e.g., via an actuator or motor driving one or more articulation pull wires).

[0056] The shaft portion may include one or more load transmission tubes for accommodating one or more pull wires. The transmission tubes offset the articulation load, allowing for improved stability of the insertion shaft. Multiple load transmission tubes 201 may reside in the lumen (i.e., tube hole) of the shaft tube and be configured to transfer the articulation reaction force from the bending segment to the handle portion. The load transmission tube is configured to transfer the articulation reaction force of the bending segment back to the handle portion, thereby reducing the articulation force to be applied to the insertion shaft tube. This design can advantageously prevent these articulation forces from being decomposed through the insertion shaft tube, thereby providing a stable shaft. The transmission mode described herein ensures that the insertion shaft tube experiences minimal axial compression or tension, thereby maintaining stability during the articulation of the bending segment.

[0057] In a preferred embodiment of the load transmission mechanism, the plurality of load transmission tubes 201 may be longer than the length of the inserted shaft tube 203. The lengths of the plurality of load transmission tubes 201 may be determined such that when the load transmission tubes are under axial compression, they are still longer than the length of the inserted shaft tube 203, thereby preventing the load from being transmitted through the inserted shaft tube. For example, the length of the load transmission tube may be at least 0.01%, 0.1%, 0.2%, 0.3%, 1%, 5%, 10% longer than the length of the inserted shaft. The length of the load transmission tube may be determined at least in part based on the inner diameter size of the shaft. For example, the load transmission tube may have a spiral configuration that provides sufficient stiffness to withstand / transmit the load.

[0058] The load transfer tube can have a size and configuration that can accommodate displacement within the shaft tube. For example, when the insertion shaft tube 203 is bent, such as due to anatomy undergoing torsion, the insertion shaft tube may cause displacement of components housed within the hole of the insertion shaft tube. In this case, the additional length of the load transfer tube can advantageously accommodate displacement within the hole of the insertion shaft tube while improving the stability of the shaft. Compared to the prior art that can utilize coils and repair rings within the handle portion, the modular design and assembly of the load transfer tube can advantageously reduce costs without affecting the performance of the shaft. Compared to other prior art techniques that have pull wires built into the shaft (such as Figure 6 Compared to the embodiment shown in the figure, the provided load transmission mechanism can advantageously transmit the load from the curved section to the handle without compressing the shaft, thereby improving the stability of the shaft.

[0059] Multiple load transfer tubes can be anchored at the proximal end 207 and the distal end 205 of the insertion shaft tube 203. As described above, because the load transfer tubes are longer than the length of the insertion shaft tube, the load transfer tubes can have a non-linear / straight configuration within the bore of the insertion shaft tube, thereby allowing flexibility to accommodate displacement caused by bending. For example, one or more load transfer tubes can have a non-linear (e.g., helical) configuration that allows movement within the main lumen of the endoscope to account for geometric changes in shaft length when the endoscope is subjected to a torsional configuration while the endoscope is placed in the anatomical structure. Such a load transfer mechanism can advantageously act as a natural spring to counteract movement from the external insertion shaft.

[0060] In some embodiments, one or more load transfer tubes may surround one or more pull wires. The articulation of the endoscope may be controlled by applying force to the distal end of the endoscope by one or more pull wires. One or more pull wires may be attached to the distal end of the endoscope. In the case of multiple pull wires, pulling one wire at a time may change the direction of the distal tip to tilt up, down, left, right, or any desired direction. In some cases, the pull wires can be anchored at the distal tip of the endoscope, pass through the curved section, and enter the handle where they are coupled to a drive component (e.g., a pulley). The handle pulley can interact with an output shaft from a robotic system.

[0061] In some embodiments, one or more pull wires may be located within or pass through the interior of one or more load transfer tubes. Figure 3A and Figure 3B An example of one or more pull wires 305 assembled with a load transmission tube 307 at a bend section 301 is shown. Figure 3A As shown, the curved segment 301 can be formed of a stainless steel strip. The curved segment can be formed of other suitable structures or materials to achieve a predetermined bending stiffness while maintaining the desired axial and torsional stiffness with low articulation forces. For example, the curved segment can include a braided structure for torsional stability. In the example shown, a plurality of pull wires 305 can pass through or be placed within the lumen of the load transmission tube 307 and the curved segment, terminating at the tip of the endoscope.

[0062] For example, a drive mechanism (e.g., an actuator, a motor) can be engaged with a pull wire to articulate the bending segment. One or more load transmission tubes can be configured to transmit at least a portion of the articulation load (e.g., compression) from the bending segment back to the handle or motor, for example, by placing one or more pull wires inside the one or more load transmission tubes, respectively. During articulation, there may be relative motion between the pull wires and the corresponding load transmission tubes. One or more load transmission tubes can transmit at least a portion of the articulation load applied to the bending segment and / or the shaft back to the handle (e.g., a motor driving one or more articulation pull wires). This can advantageously reduce at least a portion of the articulation force applied to the bending segment and / or the insertion shaft, thereby improving the stability of the insertion shaft.

[0063] The endoscope may include a bend section transition 303 at the interface of the bend section and the shaft. The bend section transition 303 may include structures that may enable efficient and convenient assembly of the endoscope. For example, the bend section transition 303 may include mechanical components such as snaps / clips to anchor a load transfer tube (e.g., a hypotube) to a cutout feature on the insertion shaft. Figure 3B Another example of a bend section transition 309 is shown. In the example shown, the load transmission tube can be anchored to the interface between the insertion shaft and the bend section by a transition ring structure welded to the bend section transition 309. This can advantageously reduce the abrupt stiffness change between the shaft portion and the bend section, thereby preventing kinking.

[0064] Figure 4 An example of a load transfer tube 401 terminating in a distal shaft region 403 and a proximal shaft region 405 is shown. As described above, the load transfer tube can have a non-linear / non-linear configuration within the bore of the insertion tube, thereby allowing flexible adjustment of displacement caused by bending. As shown in the example, the load transfer mechanism can include one or more load transfer tubes. Such a load transfer mechanism can advantageously act as a natural spring to offset movement from the external insertion shaft without the need for an additional maintenance ring at the handle portion. In the example shown, the end of the load transfer tube can be fixedly connected (e.g., welded to) a bend segment transition portion 407. The bend segment transition portion 407 may include a coupling structure 409 (e.g., a snap) to facilitate assembly to the insertion shaft.

[0065] In some cases, one or more load transfer tubes can be constructed of a material such as metal tubing or metal wound coils. The geometry and / or material of the load transfer tubes can be selected / determined to provide the desired axial and bending stiffness. For example, the material can be a metal material such as stainless steel or Nitinol, a rigid polymer such as PEEK, glass or carbon filled PEEK, Ultem, polysulfone, and other suitable materials. In some cases, one or more load transfer tubes can have an inner diameter that is greater than the outer diameter of the pull wire to allow relative movement (e.g., translation and / or rotational movement) between the load transfer tube and the pull wire. The wall thickness of one or more load transfer tubes can be determined based on the load transfer function required to transmit the articulated load of the curved segment.

[0066] Figure 5 An example of a load transfer tube 501 terminating at a distal shaft region 503 and a proximal shaft region is shown. As described elsewhere herein, the load transfer tube 501 can be located within the lumen of an insertion shaft (not shown) and outside of a working channel 505.

[0067] Figure 6 An example of an existing steerable catheter structure 600 is shown. In existing catheter designs, there is no load transmission tube, and one or more pull wires 609 are usually passed through a catheter 607, which is built into the wall of the insertion shaft 605 and the curved section 603. The catheter shaft can have a central hole / lumen 611 coaxial with the neutral axis. As shown in the cross-sectional view, the shaft wall or the curved section wall can have a built-in structure (e.g., lumen, catheter) to allow the pull wire to pass through. In this case, the shaft may be subjected to articulation loads, resulting in shaft instability.

[0068] Figure 7 An example design of an insertion shaft is shown. As described above, the insertion shaft of an endoscope can be composed of a single tube with an integrally molded structure to vary the stiffness of the shaft portion. For example, the tube can have a series of cuts (or reliefs, slits, etc.) formed along the length. The cuts in the tube can have a profile / pattern 701, 703 and density that varies along the length to produce a variable bending stiffness from the distal region to the proximal region. This can advantageously allow the bending stiffness parameter to be controlled by controlling the cuts in the insertion shaft.

[0069] Low-cost and single-use robotic bronchoscope

[0070] In another aspect of the present invention, a disposable robotic bronchoscope is provided. The robotic bronchoscope can be the same as the steerable catheter assembly described elsewhere herein. Conventional endoscopes are complex in design and are typically designed to be reused after surgery, requiring thorough cleaning, disinfection, or sterilization after each surgery. Existing endoscopes are typically designed with complex structures to ensure that the endoscope can withstand the cleaning, disinfection, and sterilization processes. The provided robotic bronchoscope can be a disposable endoscope, which can advantageously reduce cross contamination between patients and infection. In some cases, the robotic bronchoscope can be delivered to the physician in a pre-sterilized package and is intended to be discarded after a single use.

[0071] Figures 8 to 10 An example of a robotic bronchoscope according to some embodiments of the present invention is shown. Figure 8 As shown, the robotic bronchoscope 820 may include a handle portion 813 and a flexible elongated member 811. In some embodiments, the flexible elongated member 811 may include a shaft, a steerable tip, and a steerable portion. The robotic bronchoscope 820 may be used with Figure 1 The robotic bronchoscope may be a disposable robotic endoscope. In some cases, only the catheter may be disposable. In some cases, at least a portion of the catheter may be disposable. In some cases, the entire robotic bronchoscope may be released from the instrument drive mechanism and may be discarded. The bronchoscope may include varying degrees of stiffness along its axis to improve functional operation.

[0072] The robotic bronchoscope can be releasably coupled to an instrument drive mechanism 820. The instrument drive mechanism 820 can be mounted to an arm of a robotic support system or any actuated support system as described elsewhere herein. The instrument drive mechanism can provide a mechanical interface and an electrical interface to the robotic bronchoscope 820. The mechanical interface can allow the robotic bronchoscope 820 to be releasably coupled to the instrument drive mechanism. For example, a handle portion of the robotic bronchoscope can be attached to the instrument drive mechanism via a quick attach / release tool (e.g., a magnet and a spring-loaded level). In some cases, the robotic bronchoscope can be manually coupled to or released from the instrument drive mechanism without the use of tools.

[0073] Fig. 9An example of an instrument drive mechanism 920 is shown, which provides a mechanical interface for the handle portion 913 of the robotic bronchoscope. As shown in the example, the instrument drive mechanism 920 can include a set of motors that are actuated to rotationally drive a set of pull wires of the catheter. The handle portion 913 of the catheter assembly can be mounted to the instrument drive mechanism so that its pulley assembly is driven by the motor group. The number of pulleys may vary depending on the pull wire configuration. In some cases, one, two, three, four or more pull wires can be used to articulate the catheter.

[0074] The handle portion can be designed to allow the robotic bronchoscope to be disposable at a reduced cost. For example, classic manual and robotic bronchoscopes may have a cable at the proximal end of the bronchoscope handle. The cable typically includes an illumination fiber, a camera video cable, and other sensor fibers or cables, such as an electromagnetic (EM) sensor or a shape sensing fiber. Such complex cables can be expensive, increasing the cost of the bronchoscope. The provided robotic bronchoscope can have an optimized design, thereby allowing for simplified structures and components while retaining mechanical and electrical functions. In some cases, the handle portion of the robotic bronchoscope can have a cable-free design while providing a mechanical interface / electrical interface for the catheter.

[0075] Fig.10 An example of a handle portion 1000 of a robotic bronchoscope according to some embodiments of the present invention is shown. In some cases, the handle portion 1000 can be a housing or include components configured to process image data, provide power, or establish communication with other external devices. In some cases, the communication can be wireless communication. For example, the wireless communication can include Wi-Fi, radio communication, Bluetooth, IR communication, or other types of direct communication. This wireless communication capability can enable the robotic bronchoscope to function in a plug-and-play manner and can be conveniently discarded after a single use. In some cases, the handle portion can include circuit elements, such as a power supply for powering electronic devices (e.g., cameras and LED light sources) placed in the robotic bronchoscope or catheter.

[0076] The handle portion can be designed in combination with the catheter to eliminate cables or optical fibers. Depending on the mechanical structure of the catheter, for example, the catheter portion can be designed with a single working channel that allows instruments to pass through a robotic bronchoscope, as well as low-cost electronic devices such as a tip chip camera, an illumination source such as a light emitting diode (LED), and an EM sensor located in an optimal position. This can allow a simplified design of the handle portion. For example, by using LEDs for illumination, the end of the handle portion can be based solely on electric welding or wire clamping. For example, the handle portion can include a proximal plate, where the camera cable, LED cable, and EM sensor cable terminate here, and the proximal plate is connected to the interface of the handle portion and establishes an electrical connection with the instrument drive mechanism. As described above, the instrument drive mechanism is attached to a robot arm (robot support system) and provides a mechanical interface and an electrical interface for the handle portion. This can advantageously improve assembly and implementation efficiency and simplify manufacturing processes and costs. In some cases, the handle portion can be discarded after a single use together with the catheter.

[0077] Disposable steerable catheter

[0078] Fig.11 An example of a maneuverable catheter 1100 according to some embodiments of the present invention is shown. In some embodiments, the catheter can have a substantially integrated design, and one or more components can be integrated with the catheter, thereby simplifying the assembly and manufacturing process while maintaining the kinematics and dynamic performance of the maneuverable catheter. As shown in the example, the maneuverable catheter may include a slender member 1101 or a detection portion close to the tissue and / or area to be inspected. In some cases, the slender member 1101 may also be referred to as a catheter. The catheter 1101 may include internal structures such as a working channel 1103, allowing tools as described elsewhere herein to be inserted through. In some cases, the working channel may have a size such as a diameter of about 2 mm to be compatible with standard tools.

[0079] The catheter 1101 can be made of suitable materials to obtain the required flexibility or bending stiffness. In some cases, the material of the catheter can be selected so that it can maintain structural support for the internal structure (e.g., working channel) and is basically flexible (e.g., can be bent in various directions and orientations). For example, the catheter can be made of any suitable material, such as Provista copolymer, vinyl (e.g., polyvinyl chloride), nylon (e.g., vestamid, grilamid), granular alkane, polyethylene, polypropylene, polycarbonate, polyester, silicone elastomer, acetate, etc. In some cases, the material can be a polymer material, a biocompatible polymer material, and the catheter can have enough flexibility to advance through a path with a small curvature without causing pain to the object. In some cases, the catheter can include a sheath. The sheath can be different from the length of the catheter. The sheath can be shorter than the catheter to provide the required support. Alternatively, the catheter can be a single-piece component.

[0080] In some cases, the distal portion or tip of the catheter can be substantially flexible so that it can be steered in one or more directions (e.g., pitch, yaw). Figures 1 to 5 The same tip portion, curved segment and insertion shaft described in . In some embodiments, the catheter can have a variable bending stiffness along the longitudinal axis direction. For example, the catheter can include multiple parts with different bending stiffness (e.g., flexible, semi-rigid and rigid). The bending stiffness can be changed by selecting materials with different stiffness / rigidity, different structures in different parts (e.g., incisions, patterns), adding additional support components, or any combination of the above. In some cases, the proximal end of the catheter does not need to be highly curved, so the proximal portion of the catheter can be strengthened with additional mechanical structures (e.g., additional material layers) to achieve greater bending stiffness. This design can provide support and stability for the catheter. In some cases, variable bending stiffness can be achieved by using different materials during catheter extrusion. This can advantageously allow different stiffness levels along the axis of the catheter during the extrusion manufacturing process without the need for additional fastening or assembly of different materials.

[0081] The distal portion of the catheter can be manipulated by one or more pull wires 1105. The distal portion of the catheter can be made of any suitable material, such as a copolymer, a polymer, a metal or an alloy, so that it can be bent by the pull wire. In some embodiments, the proximal end or proximal portion of one or more pull wires 1105 is operably coupled to various mechanisms (e.g., gears, pulleys, etc.) in the handle portion of the catheter assembly. The pull wire 1105 can be a metal wire, cable or wire, or it can be a polymer wire, cable or wire. The pull wire 1105 can also be made of natural or organic materials or optical fibers. The pull wire 1105 can be any type of suitable wire, cable or wire that can withstand various loads without deformation, significant deformation or breakage. The distal end or distal portion of one or more pull wires 1105 can be anchored or integrated into the distal portion of the catheter so that operation of the pull wires by the control unit can apply force or tension to the distal portion of the catheter, which can be manipulated or articulated (e.g., up, down, pitch, yaw, or any direction in between) at least the distal portion of the catheter (e.g., the flexible portion).

[0082] As described above, the pull wire can be made of any suitable material, such as stainless steel (e.g., SS316), a metal, an alloy, a polymer, nylon, or a biocompatible material. The pull wire can be a wire, a cable, or a wire. In some embodiments, different pull wires can be made of different materials to change the load-bearing capacity of the pull wire. In some embodiments, different portions of the pull wire can be made of different materials to change the stiffness and / or load along the pull wire. In some embodiments, the pull wire can be used for the transmission of electrical signals. As described elsewhere herein, the pull wire can pass through the inner cavity of one or more load transmission tubes.

[0083] The catheter can have a size such that one or more electronic components can be integrated into the catheter. For example, the outer diameter of the distal tip can be approximately 4 to 4.4 millimeters (mm), and the diameter of the working channel can be around 2 mm, so that one or more electronic components can be embedded in the wall of the catheter. However, it should be noted that, depending on the application, the outer diameter can be in any range less than 4 mm or greater than 4.4 mm, and the diameter of the working channel can be in any range depending on the tool size or specific application.

[0084] One or more electronic components may include an imaging device, an illumination device, or a sensor. In some embodiments, the imaging device may be a camera 1113. The imaging device may include an optical element and an image sensor for capturing image data. The image sensor may be configured to generate image data in response to the wavelength of light. Various image sensors may be used to capture image data, such as a complementary metal oxide semiconductor (CMOS) or a charge coupled device (CCD). The imaging device may be a low-cost camera. In some cases, the image sensor may be provided on a circuit board. The circuit board may be an imaging printed circuit board (PCB). The PCB may include a plurality of electronic components for processing image signals. For example, a circuit for a CCD sensor may include an A / D converter and an amplifier to amplify and convert an analog signal provided by the CCD sensor. Alternatively, the image sensor may be integrated with an amplifier and a converter to convert an analog signal into a digital signal, thereby eliminating the need for a circuit board. In some cases, the output of the image sensor or circuit board may be image data (digital signal), which may be further processed by a camera circuit or a processor of the camera. In some cases, the image sensor may include an optical sensor array.

[0085] The lighting device may include one or more light sources 1111 positioned at the distal tip. The light source may be a light emitting diode (LED), an organic LED (OLED), a quantum dot, or any other suitable light source. In some cases, the light source may be a small LED or a dual color flash LED lighting for compact designs.

[0086] The imaging device and the lighting device may be integrated into the catheter. For example, the distal portion of the catheter may include a suitable structure that at least matches the size of the imaging device and the lighting device. The imaging device and the lighting device may be embedded in the catheter. Fig.12 An example of a distal portion of a catheter with an integrated imaging device and lighting device is shown. A camera can be located at the distal portion. The distal tip can have a structure to receive a camera, a lighting device, and / or a position sensor. For example, a camera can be embedded in a cavity 1210 at the distal tip of the catheter. The cavity 1210 can be integrally formed with the distal portion of the cavity and can have a size that matches the length / width of the camera so that the camera does not move relative to the catheter. The camera can be in close proximity to the working channel 1220 of the catheter to provide a near-field view of a tissue or organ. In some cases, the attitude or direction of the imaging device can be controlled by controlling the rotational motion (e.g., rolling) of the catheter.

[0087] The power of the camera can be provided by a wired cable. In some cases, the cable line can provide power for the lighting element or other circuit at the distal tip of the camera and the catheter in the harness. The camera and / or light source can obtain power from the power supply located at the handle portion via electric wires, copper wires or any other suitable tool that runs through the length of the catheter. In some cases, the real-time image or video of the tissue or organ can be wirelessly transmitted to an external user interface or display. Wireless communication can be WiFi, Bluetooth, RF communication or other forms of communication. In some cases, the image or video captured by the camera can be broadcast to multiple devices or systems. In some cases, the image and / or video data from the camera can be transmitted to the processor located in the handle portion via electric wires, copper wires or any other suitable tool along the length of the catheter. Image or video data can be transmitted to an external device / system via the wireless communication component in the handle portion. In some cases, the system can be designed to have no wires visible or exposed to the operator.

[0088] In conventional endoscopy, the illumination light may be provided by an optical cable that transmits the light of a light source located at the proximal end of the endoscope to the distal end of the robotic endoscope. In some embodiments of the present disclosure, a small LED light may be used and embedded in the distal portion of the catheter to reduce design complexity. In some cases, the distal portion may include a structure 1230 having a size that matches the size of the small LED light source. As shown in the illustrated example, two cavities 1230 may be formed integrally with the catheter to receive two LED light sources. For example, the outer diameter of the distal tip may be approximately 4 to 4.4 millimeters (mm) and the diameter of the working channel of the catheter may be approximately 2 mm, so that two LED light sources may be embedded at the distal end. The outer diameter may be in any range less than 4 mm or greater than 4.4 mm, and the diameter of the working channel may be in any range depending on the size of the tool or the specific application. Any number of light sources may be included. The internal structure of the distal portion may be designed to match any number of light sources.

[0089] In some cases, each LED can be connected to a power cord that can run to the proximal handle. In some embodiments, the LEDs can be soldered to separate power cords that are then bundled together to form a single strand. In some embodiments, the LEDs can be soldered to the pull wires that supply power. In other embodiments, the LEDs can be clamped or directly connected to a single pair of power cords. In some cases, a protective layer (such as a thin layer of biocompatible glue) can be applied to the front surface of the LED to provide protection while allowing light to be emitted. In some cases, an additional covering 1231 can be placed on the front end face of the distal tip to provide precise positioning of the LEDs and provide sufficient space for the glue. The covering 1231 can be made of a transparent material that matches the refractive index of the glue so that the illumination light is not blocked.

[0090] In some embodiments, one or more sensors can be embedded in the distal portion of the catheter. In conventional robotic bronchoscopes, sensors can be used to track the position of the tip, which is usually located at the distal tip, resulting in an increase in tip size. The provided steerable catheter can bundle one or more electronic components to provide a compact design. In some cases, the illumination source and one or more position sensors can be combined into a bundle. Fig.13 An example of a compact configuration of electronic components located at a distal portion is shown. In some embodiments, a position sensor such as an electromagnetic (EM) sensor can be used to accurately track the position of the distal tip of the catheter. For example, an electromagnetic coil 1310 located at the distal end can be used with an electromagnetic tracking system to detect the position and orientation of the distal tip of the catheter while it is disposed within an anatomical system (e.g., an anatomical endoluminal network). In some cases, the coil can be tilted to provide sensitivity to electromagnetic fields along different axes, giving the disclosed navigation system the ability to measure six degrees of freedom: three positions and three angles.

[0091] In some cases, one or more EM sensors 1310 can be located at the distal portion and can be placed in a stereoscopic arrangement next to or behind an illumination light source 1320 (e.g., LED). In some cases, the EM sensor and LED light source can form a bundle 1300. The power cables of the EM sensors can be bundled with the wires of the LED to provide reduced space and complexity. In some cases, stereo alignment can provide differential 5D measurements or fused 6D measurements, which allows accurate positioning and direction sensing of the distal tip of the catheter. During surgery, an EM field generator located next to, below, or above the patient's torso can position the EM sensor to track the position of the catheter tip in real time.

[0092] Cable configuration and design

[0093] The robotic bronchoscope may include one or more pull wires for controlling articulation of the catheter. In conventional endoscopes, the distal end or distal portion of the one or more pull wires may be anchored or mounted to a control ring such that manipulation of the pull wires by a control unit may apply a force or tension to the control ring that may steer or articulate (e.g., up, down, pitch, yaw, or any direction in between) a segment or portion of the catheter (e.g., the distal portion). Fig.14 Examples of conventional configurations of pull wires 1413 attached to a control ring structure 1411 and novel configurations 1420 of the present disclosure are shown. The control ring can be attached to the distal end of the catheter 1415. Typically, the tip of the pull wire is welded or soldered to the control ring 1411, and the control ring can also be attached to the distal tip by welding. The welding process can be expensive, cumbersome, and complicated. In addition, when one pull wire breaks or fails, the entire steering control function may be affected.

[0094] The provided robotic bronchoscope may include individually controlled pull wires, each of which is directly connected to the distal portion. As shown in example 1420, one or more pull wires 1423 may be attached to an integrally formed structure 1421 of the distal portion. For example, the integrally formed structure 1421 may be a groove molded with the distal tip. The groove may have a size or size that matches the size of the distal end 1421 of the pull wire so that the pull wire can be conveniently curled at the distal end. This can advantageously improve assembly efficiency. In some cases, the pull wire may be rigidly fixed to the groove at the distal end so that the distal end of the pull wire may not be allowed to move relative to the distal portion of the catheter.

[0095] The pull wire configuration may also provide increased reliability when manipulating the distal portion. For example, since each pull wire is individually connected to the distal portion and individually controlled, the articulation force may be dynamically adjusted based on different pull wire configurations. For example, in the event of a pull wire break, the articulation force may be recalculated and the control signal used to control the pull wire may be dynamically adjusted based on the available pull wires.

[0096] Conveniently assembling the pull wires to the distal portion can also allow flexibility in designing the pull wire configuration. For example, the number or combination of pull wires can be dynamically selected or adjusted to meet different performance or design requirements. Fig.15 Various configurations of pull wires for a robotic catheter system are shown. In some embodiments, the overall structure (groove) for receiving the pull wire can be prefabricated. For example, four grooves can be formed integrally with the catheter, and one or more pull wires can be fixedly connected / clamped to one or more grooves selected from a plurality of grooves to form different configurations 1510, 1530. As shown in the example, any number of grooves / slots or any given subset of grooves / slots can be selected to receive or couple to the pull wire at one end. In some cases, once a combination of slots / grooves is selected to couple to the corresponding pull wire, a pull wire configuration pattern can be formed, and the mapping relationship between the selected grooves / slots and the pull wire can be transmitted to the control unit. A control signal can then be generated based on the mapping relationship during articulation to achieve the desired articulation force.

[0097] In another example, the prefabricated grooves can have various configurations. For example, the three-wire configuration 1520 can have three grooves separated by 120°. In some cases, the virtual mapping algorithm can map the three-wire configuration to a four-wire configuration. When one or more pull wires fail / damaged during operation, the virtual mapping algorithm can also be used to update the new mapping relationship. This overall design of the pull wire configuration advantageously simplifies the assembly and manufacturing process while retaining the kinematic and dynamic performance of the catheter.

[0098] Guidewire with inflatable tip

[0099] In some embodiments, a guide wire can be used during a bronchoscopic procedure. The guide wire can typically be inserted well beyond the tip of the bronchoscope to first access the desired air passageway, followed by allowing the bronchoscope to slide over the guide wire into the selected passageway. Due to the smaller diameter of the guide wire compared to the bronchoscope, the guide wire may not have sufficient stiffness and / or sufficient friction to anchor the guide wire within the air passageway.

[0100] The guidewire of the present disclosure may be characterized by an expandable outer diameter at the tip. Fig.16 An example of a guide wire 1600 with an inflatable tip is shown. A guide wire 1601 can be inserted through the working channel of a catheter / bronchoscope to help guide the air passage in the lungs. In some cases, the guide wire can extend beyond the tip of the catheter into the desired airway, and then the catheter can slide over the guide wire to reach the desired position. Various suitable methods can be used to implement the inflatable tip. For example, an additional component 1603 such as an inflatable balloon can be positioned at or near the distal end of the guide wire. The balloon can be connected to a balloon inflation source or pump through the working channel for inflation or deflation of the balloon.

[0101] In some cases, the guidewire may include perforations. The diameter of the deflated balloon may be equal to the diameter of the elongated arm (e.g., bronchoscope catheter). In some cases, the diameter of the deflated balloon may be slightly larger than the elongated arm. The guidewire may be able to move distally or proximally. The guidewire may be attached to an air pump to inject air and extract air from the guidewire, respectively inflating and deflation of the balloon. During the insertion of the guidewire into the air passage, the balloon may remain deflated. When the appropriate position is reached, the balloon will be inflated by pumping in air. Once the bronchoscope reaches the desired forward position, the balloon can be deflated by pumping out air, which allows the guidewire to move forward. In some embodiments, the inflatable tip can be made of a foldable mesh structure using materials such as shape memory alloys (SMA), electroactive polymers (EAPs), and ferromagnetic fluids, and has a corresponding inflation and deflation control mechanism. The anchoring element may have any other form to fix the anchoring of the guidewire. For example, the anchoring element can be a wire that can expand or contract radially. The anchoring element can be actuated by a sliding actuator that slides linearly to cause the anchoring element to change its position, in particular to cause the anchoring element to either unfold or return to a folded position. The sliding action of the actuator can be translated into a change in the position (state) of the anchoring element (e.g., the anchoring element unfolds and radially expands to provide a structure to hold the anchoring guidewire in place, or conversely, the anchoring element radially contracts and returns to a folded state).

[0102] Fig.17Another example of a catheter tip design 1701 is shown. In the example shown, the diameter of the tip 1701 can be larger than the diameter of the curved section 1702 and / or the shaft 1703. The working channel 1708 can be deformable (e.g., expandable / squeezable). The working channel 1708 can be formed of a resilient material (e.g., plastic) that can accommodate instruments of variable size. For example, larger instruments such as biopsy, therapeutic instruments, energy devices, when inserted through the working channel 1708, can expand the tip portion of the working channel.

[0103] In a first example 1710, the LED light source or light guide can be replaced after the endoscope reaches the target location. In a second example 1712, the LED light source 1711 can be embedded in the tip. In a third example 1713, the LED light source can be embedded in the tip and the light guide can be removable. The tip can include other electronic components, such as a camera 1707 described elsewhere herein. The endoscope can also include a handle portion 1704 similar to the handles described elsewhere herein. For example, the handle portion can include a Luer connector 1705 and an electrical interface 1706 for various functions.

[0104] The present invention provides embodiments including but not limited to the following:

[0105] 1. An articulated flexible endoscope, comprising:

[0106] a distal tip portion that is manipulable by a drive mechanism;

[0107] a curved segment connected at a first end to the distal tip portion and connected to the shaft portion at a transition interface, wherein the curved segment is articulated by one or more pull wires; and

[0108] The shaft portion includes one or more load transmission tubes for accommodating the one or more pull wires, thereby improving the stability of the shaft portion.

[0109] 2. An articulated flexible endoscope according to embodiment 1, wherein the distal tip portion includes a structure for receiving an imaging device, a position sensor, and an illumination device.

[0110] 3. The articulated flexible endoscope according to embodiment 1, wherein each of the one or more pull wires is placed within the inner lumen of each of the one or more load transmission tubes.

[0111] 4. An articulated flexible endoscope according to embodiment 1, wherein the bending section is bent in two or more directions by the one or more pull wires.

[0112] 5. An articulated flexible endoscope according to embodiment 1, wherein the one or more load transmission tubes are anchored to the transition interface and have a length greater than the length of the shaft portion.

[0113] 6. An articulated flexible endoscope according to embodiment 1, wherein the one or more load transmission tubes have a non-linear configuration.

[0114] 7. An articulated flexible endoscope according to embodiment 1, wherein the one or more load transmission tubes have a spiral configuration.

[0115] 8. The articulated flexible endoscope according to embodiment 1, wherein the shaft portion includes a tube having an integrally molded structure to change the stiffness of the shaft portion.

[0116] 9. The articulated flexible endoscope according to embodiment 1 further includes a deformable working channel.

[0117] 10. The articulated flexible endoscope according to embodiment 1 further includes a handle portion, wherein the handle portion includes one or more components, and the one or more components are configured to process image data, provide power to one or more electronic components located in the distal tip portion, or establish communication with an external device.

[0118] 11. An articulated flexible endoscope according to embodiment 10, wherein the handle portion includes an interface configured to couple the handle portion to an instrument drive mechanism.

[0119] 12. An articulated flexible endoscope according to embodiment 11, wherein the interface is an electrical interface and a mechanical interface.

[0120] 13. An articulated flexible endoscope according to embodiment 10, wherein the handle portion includes a mechanical control module for engaging an irrigation system or a suction system.

[0121] 14. A disposable endoscope comprising:

[0122] a distal tip portion that includes an imaging device, a position sensor, and an illumination device;

[0123] a curved segment connected at a first end to the distal tip portion and connected at a second end to the shaft portion, wherein the curved segment is articulated by one or more pull wires; and

[0124] The shaft portion includes one or more load transmission tubes for accommodating the one or more pull wires, thereby improving the stability of the shaft portion.

[0125] 15. The disposable endoscope of embodiment 14, wherein the distal tip portion comprises a structure for receiving the imaging device, the position sensor and the lighting device.

[0126] 16. The disposable endoscope of embodiment 14, wherein the imaging device, the position sensor, and the lighting device are arranged in a compact configuration.

[0127] 17. A disposable endoscope according to embodiment 14, wherein the one or more load transmission tubes have a length greater than the length of the shaft portion.

[0128] 18. The disposable endoscope according to embodiment 14, wherein each of the one or more pull wires is placed within the inner lumen of each of the one or more load transfer tubes.

[0129] 19. The disposable endoscope of embodiment 14, wherein the one or more pull wires are movable relative to the one or more load transmission tubes.

[0130] 20. The disposable endoscope according to embodiment 14, wherein the bending section is bent along two or more directions by the one or more pull wires.

[0131] 21. The disposable endoscope of embodiment 14, wherein the one or more load transfer tubes have a non-linear configuration.

[0132] 22. The disposable endoscope of embodiment 14, wherein the one or more load transfer tubes have a spiral configuration.

[0133] 23. The disposable endoscope according to embodiment 14, wherein the shaft portion comprises a tube having an integrally molded structure to change the stiffness of the shaft portion.

[0134] 24. The disposable endoscope according to embodiment 14 further comprises a deformable working channel.

[0135] 25. According to embodiment 14, the disposable endoscope further includes a handle portion, wherein the handle portion includes one or more components, and the one or more components are configured to process image data, provide power to the imaging device, the position sensor and the lighting device, or establish communication with an external device.

[0136] 26. The disposable endoscope of embodiment 25, wherein the handle portion comprises an interface configured to couple the handle portion to an instrument drive mechanism.

[0137] 27. A disposable endoscope according to embodiment 26, wherein the interface includes an electrical interface and a mechanical interface.

[0138] 28. The disposable endoscope of embodiment 27, wherein the mechanical interface is configured to releasably couple the handle portion to the instrument drive mechanism.

[0139] Although preferred embodiments of the present invention have been shown and described herein, it is readily understood by those skilled in the art that these embodiments are provided as examples only. Without departing from the present invention, those skilled in the art will now appreciate that many variations, changes and substitutions may be employed. It should be understood that various alternatives to the embodiments of the present invention described herein may be employed in the implementation of the present invention. The appended claims are intended to define the scope of the present invention, and methods and structures within the scope of these claims and their equivalents are thus covered.

Claims

1. An articulated flexible endoscope, include: a distal tip portion that is manipulable by a drive mechanism; a curved segment connected at a first end to the distal tip portion and connected to the shaft portion at a transition interface, wherein the curved segment is articulated by one or more pull wires; and The shaft portion includes one or more load transmission tubes for accommodating the one or more pull wires, thereby improving the stability of the shaft portion.

2. An articulated flexible endoscope according to claim 1, wherein the distal tip portion includes a structure for receiving an imaging device, a position sensor and an illumination device.

3. The articulated flexible endoscope of claim 1, wherein each of the one or more pull wires is placed within the lumen of a respective load transfer tube of the one or more load transfer tubes.

4. The articulated flexible endoscope according to claim 1, wherein the bending section is bent in two or more directions by the one or more pull wires.

5. The articulated flexible endoscope of claim 1, wherein the one or more load transmission tubes are anchored to the transition interface and have a length greater than the length of the shaft portion.

6. The articulated flexible endoscope of claim 1, wherein the one or more load transmission tubes have a non-linear configuration.

7. The articulated flexible endoscope of claim 1, wherein the one or more load transfer tubes have a helical configuration.

8. The articulated flexible endoscope according to claim 1, wherein the shaft portion comprises a tube having an integrally molded structure to change the stiffness of the shaft portion.

9. The articulated flexible endoscope of claim 1, further comprising a deformable working channel.

10. A disposable endoscope, include: a distal tip portion that includes an imaging device, a position sensor, and an illumination device; a curved segment connected at a first end to the distal tip portion and connected at a second end to the shaft portion, wherein the curved segment is articulated by one or more pull wires; and The shaft portion includes one or more load transmission tubes for accommodating the one or more pull wires, thereby improving the stability of the shaft portion.

Images