Systems and methods for articulatable instrument bending section

Abstract

A bending section for an articulatable instrument is provided. The bending section may have composite structure comprising one or more wire forms having a substantially alternating square wave pattern; two or more vertebra segments engaged with the one or more wire forms at one or more locations. The square wave pattern may have wave peaks or wave troughs and a vertebra segment is engaged with a wire form at a transitional location between two wave peaks.

Description

Attorney Docket No. 55441-733601SYSTEMS AND METHODS FOR ARTICULATABLE INSTRUMENT BENDING SECTIONCROSS-REFERENCE

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 699,900, filed on September 27, 2024, which is entirely incorporated herein by reference.BACKGROUND

[0002] 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 into the organ directly. Flexible endoscope that can deliver instinctive steering and control is useful in diagnosing and treating diseases that are accessible through any natural orifice in the body. Depending on the clinical indication, the endoscope may be designated as bronchoscope, ureteroscope, colonoscope, gastroscope, ENT scope, and various others. For example, flexible bronchoscope may be used for lung cancer diagnosis and / or surgical treatment. However, one challenge in bronchoscopy is reaching the upper lobe of the lung while navigating through the airways. In another example, flexible endoscopy has been used to inspect and treat disorders of the gastrointestinal (GI) tract without the need for creating an opening on the patient's body. The endoscope is introduced via the mouth or anus into the upper or lower GI tracts respectively. A miniature camera at the distal end captures images of the GI wall that help the clinician in their diagnosis of the GI diseases. Simple surgical procedures (like polypectomy and biopsy) can be performed by introducing a flexible tool via a working channel to reach the site of interest at the distal end.

[0003] Endoscopes are traditionally made to be re-usable, which may require thorough cleaning, dis-infection, and / or sterilization after each procedure. In most cases, cleaning, disinfection, and sterilization may be aggressive processes to kill germs and / or bacteria. Such procedures may also be harsh on the endoscopes themselves. Therefore, the designs of such reusable endoscopes can often be complicated, especially to ensure that the endoscopes can survive such harsh cleaning, dis-infection, and sterilization protocols. Periodical maintenance and repairs for such re-usable endoscopes may often be needed.

[0004] Low cost, disposable medical devices designated for a single-use have become popular for instruments that are difficult to clean properly. Single-use, disposable devices may be packaged in sterile wrappers to avoid the risk of pathogenic cross-contamination of diseases such as HIV, hepatitis, and other pathogens. Hospitals generally prefer the convenience of single-use disposable products because they no longer have to be concerned with product age, overuse,Attorney Docket No. 55441-733601 breakage, malfunction, and sterilization. However, conventional endoscopes often rely on additional guiding elements, such as guide wires to guide the endoscope, or incorporate complex shaft designs, including linked segments or snake-like mechanisms, to successfully navigate tortuous or highly convoluted anatomical passageways. These added components increase the device’s mechanical complexity, manufacturing cost, and cleaning requirements, making such designs challenging to produce as single-use instruments. Consequently, they are often unsuitable for disposable applications, limiting their utility in settings where sterility, rapid deployment, or cost-effectiveness is critical.SUMMARY

[0005] Recognized herein is a need for a robotic endoscope that allows for performing surgical procedures or diagnostic operations with improved performance and cost-efficiency. Recognized also herein are devices and systems comprising endoscopes which may be disposable and may not require extensive cleaning procedures. An endoscope may comprise a steerable shaft for delivering diagnostics and therapeutics to different parts of a body. The distal ends of these shafts are commonly steered with tendons (also referred to as pull wires) in one or more directions.

[0006] The steerable section where the distal ends of the tendons connected to is referred to as bending section. For example, distal end of the tendons may be anchored to a distal end of the bending section (that connects to the rigid distal end of the endoscope). The ideal bending section exhibits high stiffness under compression, extension, and torsion to prevent prolapse and maintain stability, while being flexible under bending to enable smooth steering, spring-back, and low hysteresis. Achieving this combination of properties, while maintaining a low manufacturing cost, is a significant technical challenge.

[0007] Existing methods or devices for creating the distal steering segments (bending section) are typically employing structures such as “flexures” or “joints” (jointed vertebrae). Flexures are typically vertebrae that are linked via an integral beam that flexes during bending while resisting compression, extension and torsion. Flexures are usually made from polymeric materials or metallic materials such as stainless steel or NiTi (Nickel titanium or Nitinol). The manufacturing methods for fabricating polymer flexures typically involve molding or cutting by relieving material around the flexure. The manufacturing methods for fabricating metallic flexures typically involve subtractive manufacturing techniques such as laser cutting or wire Electrical Discharge Machine (EDM). Flexure bending sections rely on the material in the flexure deflecting and returning to its original shape following a deflection. Such design limits the material choices or the articulation angles to avoid yielding the material and hysteresis.Attorney Docket No. 55441-733601Using Nitinol as the flexure material and fabricating the material into the flexure structure require the complex and costly material removal methods as described above (e.g., machining, wire EDM and laser cutting). In particular, such manufacturing methods and techniques are less cost effective than other fabrication method such as injection molding.

[0008] Jointed steering segments, on the other hand, involve vertebrae connected via pivot points, rather than flexing beams. Some pivot points are captive within sockets to resist tensile loads, while others are loosely stacked and may separate under light tensile force. While jointed designs can offer flexibility, achieving high performance remains expensive and technically challenging. For instance, while polymer-molded vertebrae may be cost-effective at high volumes, they require complex tooling and are often limited to single-plane bending due to molding constraints.

[0009] Additionally, a single plane of bending can beneficially ensure a consistent plane of material that can resist compressive and tensile loads. However, current multiplane polymer flexures do not have a consistent plane of material that can support compressive and tensile loads so they tend to stretch on extension and collapse on compression in ways that limit the tendon tension, articulation angles and payload capacities. These limitations are further exacerbated by the lower stiffness of polymeric materials, which must allow for sufficient deflection before plastic deformation occurs.

[0010] The present disclosure provides a flexible endoscope with improved performance at reduced cost. The present disclosure addresses the aforementioned issues by providing a unique structural design of the bending section thereby allowing for both the benefits of molding polymers and the benefits of NiTi flexures. In particular, the bending section of the present disclosure has a unique modular feature allowing for a manufacturing process without requiring the typical complex tooling for polymer flexures or the complex manufacturing techniques for NiTi flexures. For instance, unlike conventional bending section formed of either NiTi flexures or polymer flexures, the bending section of the present disclosure is partially formed of unique vertebrae modulars made of polymeric material and partially formed of unique wire form modulars made of NiTi material. The modular vertebrae and modular wire forms are assembled to achieve an overall improved mechanism performance of the bending section while reducing the manufacturing cost.

[0011] In some embodiments of the bending section, a series of vertebrae are linked to one another through wire forms. The vertebrae may be fabricated by injection molding, enabling cost-effective, high-volume production. The vertebrae may be made of materials such as polymeric material that is low cost and can be fabricated utilizing a low-cost fabricationAttorney Docket No. 55441-733601 techniques such as injection molding. The wire forms may be made of NiTi or other suitable metallic material. The wire forms may have a simple shape and structure allowing it to be fabricated utilizing simple but high volume and cost-effective techniques such as cold working or thermal shape setting. The combination of vertebrae and wire forms provides a modular, high- performance bending mechanism, enabling steerability, stability, and improved articulation without the complexity or expense associated with conventional flexure-based or jointed designs.

[0012] In an aspect, a composite bending section structure for an articulatable instrument is provided. The composite bending section may comprise a wire form having a substantially alternating square wave pattern; and two or more vertebrae configured to engage the wire form at one or more transitional locations between square wave peaks of the square wave pattern.

[0013] In some embodiments, the vertebrae segments may comprise receiving structures formed on an outer surface thereof for capturing and retaining the wire form. In some cases, the composite bending section structure may further comprise an outer jacket positioned over the vertebrae segments, and the outer jacket and the receiving structures cooperate to capture and retain the wire form at the transitional locations. In some cases, the receiving structures may comprise at least one of channels, grooves, reliefs, or pockets formed on the outer surface of the vertebrae segments. In some embodiments, the wire form may extend into a shaft of the articulatable instrument to couple the bending section to the shaft, or may extend into a tip of the articulatable instrument to couple the bending section to the tip. In some embodiments, the composite bending section structure may further comprise one or more tendons for controlling a direction and amplitude of bending of the bending section.

[0014] In some embodiments, two wire forms may be included to create two bending planes, and the bending planes may be orthogonal to one another or may not be orthogonal to one another. In some embodiments, two consecutive vertebrae segments may form a pair with alternating mirror images to one another. In some embodiments, the wire form may have a substantially circular cross section or may have a non-circular cross section. In some embodiments, the wire form may be fabricated from a material selected from the group consisting of NiTi, stainless steel, and metallic alloys. In some embodiments, a flexible endoscope may comprise the composite bending section structure, and the flexible endoscope further comprises a proximal shaft, a distal tip, and a working channel extending through the composite bending section structure.

[0015] As used herein, the term "substantially alternating square wave pattern" may refer to a geometric configuration of a wire form characterized by alternating peaks and troughs that approximate a square wave function, where the transitions between peaks and troughs areAttorney Docket No. 55441-733601 substantially perpendicular to the longitudinal axis of the wire form. The square wave pattern may include wave peaks, wave troughs, and transitional segments connecting the peaks and troughs, with the pattern providing controlled flexing points along the length of the bending section.

[0016] According to another aspect of the present disclosure, a composite bending section structure for an articulatable instrument is provided. The composite bending section may comprise a wire form having a substantially alternating arc-shaped wave pattern with wave peaks and wave troughs; and two or more vertebrae segments configured to engage the wire form at one or more transitional locations between the wave peaks or at the wave troughs.

[0017] In some embodiments, the vertebrae segments may comprise receiving structures formed on an outer surface thereof for capturing and retaining the wire form. In some cases, the composite bending section structure may further comprise an outer jacket positioned over the vertebrae segments, and the outer jacket applies radial compression to retain the wire form against the vertebrae segments. In some cases, the transitional locations may serve as controlled flexing points that enable precise articulation while maintaining structural integrity of the bending section. According to a further aspect of the present disclosure, a composite bending section structure for an articulatable instrument is provided. The composite bending section may comprise a plurality of vertebrae segments fabricated from polymeric materials, each vertebra segment having external receiving structures and internal lumens; at least one wire form fabricated from metallic materials and having a predetermined geometric pattern; and the external receiving structures of the vertebrae segments engage the wire form at transitional locations to provide controlled flexing points along the bending section.

[0018] In some embodiments, low-cost, single-use articulatable endoscope for diagnosis and treatment is provided and can be used in various applications such as bronchoscopy, urology, gynecology, arthroscopy, orthopedics, ENT, gastro-intestine endoscopy, neurosurgery, and various others. In some cases, the present disclosure provides a single-use, disposable, robotically controlled bronchoscope for use with a robotic system to enable diagnostic evaluation of lesions anywhere in the pulmonary anatomy. It should be noted that the provided endoscope systems can be used in various minimally invasive surgical procedures, therapeutic or diagnostic procedures that involve various types of tissue including heart, bladder and lung tissue, and in other anatomical regions of a patient’s body such as a digestive system, including but not limited to the esophagus, liver, stomach, colon, urinary tract, or a respiratory system, including but not limited to the bronchus, the lung, and various others.Attorney Docket No. 55441-733601

[0019] It should be noted that the provided modular endoscope components and various components of the device can be used in various minimally invasive surgical procedures, therapeutic or diagnostic procedures that involve various types of tissue including heart, bladder and lung tissue, and in other anatomical regions of a patient’s body such as a digestive system, including but not limited to the esophagus, liver, stomach, colon, urinary tract, or a respiratory system, including but not limited to the bronchus, the lung, and various others. The provided systems, methods and apparatuses can be applied to any subject that may or may not be human and may or may not be an animal.INCORPORATION BY REFERENCE

[0020] All publications, patents, and patent applications mentioned in this specification are herein incorporated 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 publications and patents or patent applications incorporated by reference contradict the disclosure contained in the specification, the specification is intended to supersede and / or take precedence over any such contradictory material.BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The novel features of the invention are set forth with particularity 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 that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings (also “Figure” and “FIG.” herein), of which:

[0022] FIGs. 1-2 shows an example of a bending section, in accordance with some embodiments of the present disclosure.

[0023] FIG. 3 schematically shows an example of one or more wire forms having a substantially square wave pattern.

[0024] FIG. 4 shows various different cross-sections of a wire form.

[0025] FIG. 5 shows an example of terminating or coupling a proximal end of the wire form to the proximal shaft.

[0026] FIG. 6 shows an example of the tapered channel for the pull wire for convenient termination at the distal end and proximal end of the bending section.

[0027] FIG. 7 shows an example of a pair of consecutive vertebrae segments and a wire form component coupled to it.Attorney Docket No. 55441-733601

[0028] FIG. 8 shows examples of different angles between two bending planes.

[0029] FIG. 9 shows an example of a bending section having two wire forms.

[0030] FIG. 10 shows an example of an additional component added to a vertebra segment.

[0031] FIG. 11 illustrates an example of a flexible endoscope, in accordance with some embodiments of the present disclosure.

[0032] FIG. 12 shows an example of an instrument driving mechanism providing mechanical interface to the handle portion of the robotic endoscope.

[0033] FIG. 13 and FIG. 14 show an example of an instrument driving mechanism (IDM) providing a mechanical interface to the handle portion of the robotic endoscope.

[0034] FIG. 15 shows an example of a distal tip of an endoscope.DETAILED DESCRIPTION

[0035] While various embodiments of the invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions may occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed.

[0036] The embodiments disclosed herein can be combined in one or more of many ways to provide improved diagnosis and therapy to a patient. The disclosed embodiments can be combined with existing methods and apparatus to provide improved treatment, such as combination with known methods of pulmonary diagnosis, surgery and surgery of other tissues and organs, for example. It is to be understood that any one or more of the structures and steps as described herein can be combined with any one or more additional structures and steps of the methods and apparatus as described herein, the drawings and supporting text provide descriptions in accordance with embodiments.

[0037] While exemplary embodiments will be primarily directed at a device or system for bronchoscopy or colonoscopy, one of skill in the art will appreciate that this is not intended to be limiting, and the devices described herein may be used for other therapeutic or diagnostic procedures and in various anatomical regions of a patient’s body. The provided device or system can be utilized in urology, gynecology, rhinology, otology, laryngoscopy, gastroenterology with the endoscopes, combined devices including endoscope and instruments, endoscopes with localization functions, one of skill in the art will appreciate that this is not intended to be limiting,Attorney Docket No. 55441-733601 and the devices described herein may be used for other therapeutic or diagnostic procedures and in other anatomical regions of a patient’s body, such as such as brain, heart, lungs, intestines, eyes, skin, kidney, liver, pancreas, stomach, uterus, ovaries, testicles, bladder, ear, nose, mouth, soft tissues such as bone marrow, adipose tissue, muscle, glandular and mucosal tissue, spinal and nerve tissue, cartilage, hard biological tissues such as teeth, bone and the like, as well as body lumens and passages such as the sinuses, ureter, colon, esophagus, lung passages, blood vessels and throat, and various others, in the forms of: NeuroendoScope, EncephaloScope, Ophthalmoscope, OtoScope, RhinoScope, LaryngoScope, GastroScope, EsophagoScope, BronchoScope, ThoracoScope, PleuroScope, AngioScope, MediastinoScope, NephroScope, GastroScope, DuodenoScope, CholeodoScope, CholangioScope, LaparoScope, AmioScope, UreteroScope, HysteroScope, CystoScope, ProctoScope, ColonoScope, ArthroScope, SialendoScope, Orthopedic Endoscopes, and others, in combination with various tools or instruments.

[0038] The systems and apparatuses herein can be combined in one or more of many ways to provide improved diagnosis and therapy to a patient. Systems and apparatuses provided herein can be combined with existing methods and apparatus to provide improved treatment, such as combination with known methods of pulmonary diagnosis, surgery and surgery of other tissues and organs, for example. It is to be understood that any one or more of the structures and steps as described herein can be combined with any one or more additional structures and steps of the methods and apparatus as described herein, the drawings and supporting text provide descriptions in accordance with embodiments.

[0039] Whenever the term “at least,” “greater than,” or “greater than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “at least,” “greater than” or “greater than or equal to” applies to each of the numerical values in that series of numerical values. 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.

[0040] Whenever the term “no more than,” “less than,” or “less than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “no more than,” “less than,” or “less than or equal to” applies to each of the numerical values in that series of numerical values. 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.

[0041] As used herein, the terms distal and proximal may generally refer to locations referenced from the apparatus, and can be opposite of anatomical references. For example, a distal location of a primary shaft or catheter may correspond to a proximal location of anAttorney Docket No. 55441-733601 elongate member of the patient, and a proximal location of the primary sheath or catheter may correspond to a distal location of the elongate member of the patient.

[0042] An endoscope may comprise a steerable shaft for delivering diagnostics and therapeutics to different parts of a body. The distal ends of these shafts are commonly steered with tendons (also referred to as pull wires) in one or more directions.

[0043] The steerable section where the distal ends of the tendons connected to is referred to as bending section. The ideal bending section exhibits high stiffness under compression, extension, and torsion to prevent prolapse and maintain stability, while being flexible under bending to enable smooth steering, spring-back, and low hysteresis. Achieving this combination of properties, while maintaining a low manufacturing cost, is a significant technical challenge.

[0044] Existing methods or devices for creating the distal steering segments (bending section) are typically employing structures such as “flexures” or “joints” (jointed vertebrae). Flexures are typically vertebrae that are linked via an integral beam that flexes during bending while resisting compression, extension and torsion. Flexures are usually made from polymeric materials or metallic materials such as stainless steel or NiTi (Nickel titanium or Nitinol). The manufacturing methods for fabricating polymer flexures typically involve molding or cutting by relieving material around the flexure. The manufacturing methods for fabricating metallic flexures typically involve subtractive manufacturing techniques such as laser cutting or wire Electrical Discharge Machine (EDM). Flexure bending sections rely on the material in the flexure deflecting and returning to its original shape following a deflection. Such design limits the material choices or the articulation angles to avoid yielding the material and hysteresis.Using Nitinol as the flexure material and fabricating the material into the flexure structure require the complex and costly material removal methods as described above (e.g., machining, wire EDM and laser cutting). In particular, such manufacturing methods and techniques are less cost effective than other fabrication method such as injection molding.

[0045] Jointed steering segments, on the other hand, involve vertebrae connected via pivot points, rather than flexing beams. Some pivot points are captive within sockets to resist tensile loads, while others are loosely stacked and may separate under light tensile force. While jointed designs can offer flexibility, achieving high performance remains expensive and technically challenging. For instance, while polymer-molded vertebrae may be cost-effective at high volumes, they require complex tooling and are often limited to single-plane bending due to molding constraints.

[0046] Additionally, a single plane of bending can beneficially ensure a consistent plane of material that can resist compressive and tensile loads. However, current multiplane polymerAttorney Docket No. 55441-733601 flexures do not have a consistent plane of material that can support compressive and tensile loads so they tend to stretch on extension and collapse on compression in ways that limit the tendon tension, articulation angles and payload capacities. These limitations are further exacerbated by the lower stiffness of polymeric materials, which must allow for sufficient deflection before plastic deformation occurs.

[0047] The present disclosure provides a flexible endoscope with improved performance at reduced cost. The present disclosure addresses the aforementioned issues by providing a unique structural design of the bending section thereby allowing for both the benefits of molding polymers and the benefits of NiTi flexures. In particular, the bending section of the present disclosure has a unique modular feature allowing for a manufacturing process without requiring the typical complex tooling for polymer flexures or the complex manufacturing techniques for NiTi flexures. For instance, unlike conventional bending section formed of either NiTi flexures or polymer flexures, the bending section of the present disclosure is partially formed of unique vertebrae modulars made of polymeric material and partially formed of unique wire form modulars made of NiTi material. The modular vertebrae and modular wire forms are assembled to achieve an overall improved mechanism performance of the bending section while reducing the manufacturing cost.

[0048] In some embodiments of the bending section, a series of vertebrae are linked to one another through wire forms. As used herein, the term "wire form" may generally refer to a continuous element having a predetermined geometric pattern that provides structural linkage between vertebrae segments while enabling controlled flexion at specific locations. The wire form may be fabricated from materials such as NiTi (Nickel titanium or Nitinol), stainless steel, or other suitable metallic materials, and may have various cross-sectional shapes including circular, rectangular, or triangular configurations.

[0049] The vertebrae may be fabricated by injection molding, enabling cost-effective, high-volume production. The vertebrae may be made of materials such as polymeric material that is low cost and can be fabricated utilizing a low-cost fabrication techniques such as injection molding. The wire forms may be made of NiTi or other suitable metallic material. The wire forms may have a simple shape and structure allowing it to be fabricated utilizing simple but high volume and cost-effective techniques such as cold working or thermal shape setting. The combination of vertebrae and wire forms provides a modular, high-performance bending mechanism, enabling steerability, stability, and improved articulation without the complexity or expense associated with conventional flexure-based or jointed designs.Attorney Docket No. 55441-733601

[0050] In some embodiments, the wire forms (e.g., NiTi wire forms) may be coupled to the vertebrae by nesting within receiving structures formed on the vertebrae, such as channels, grooves, or reliefs on the outer surface or outer diameter. These receiving structures may be precisely dimensioned to accommodate the cross-sectional geometry of the wire forms, ensuring a secure fit and alignment along the length of the bending section. In some cases, the vertebrae may be formed of a rigid polymer, providing structural stability while maintaining compatibility with the wire form. The wire forms may be captured within the receiving structures and further stabilized by an outer jacket positioned over the vertebrae, which applies radial compression and retains the wire forms against the vertebrae surface. The combination of the receiving structures and the outer jacket ensures that the wire forms remain properly seated during bending and articulation, prevents lateral or rotational displacement, and contributes to the mechanical integrity and repeatable steering performance of the bending section. Additionally, the placement of the wire forms within the reliefs or channels may allow for controlled flexion and torsion, with the geometry of the nesting structures tuned to balance stiffness, flexibility, and spring-back characteristics of the composite bending section.

[0051] The rigid vertebrae beneficially serve to localize flexural loading to one or more predetermined flexing points along the NiTi wire form. By constraining flexion to specific points, the modular design allows for precise control over bending behavior and enables adjustable placement of the flexing points by altering the locations at which the wire form is coupled to the vertebrae. This combination of modular wire form and vertebra provides advantage over conventional designs in which flexing points are integral to the vertebrae or beams, as the continuous wire form flexures can sustain higher flexural loads and exhibit improved spring-back performance. For example, the switchback configuration of the wire form inherently resists both tensile and compressive forces, providing a robust flexing mechanism. The modularity of the system permits the flexing points to be arranged linearly between vertebrae, optimizing the bending section’s ability to resist axial tensile and compressive loads efficiently. Alternatively, the flexures can be positioned in non-linear arrangements, such as arc-shaped lines or zigzag patterns, to tailor the bending characteristics to specific applications or anatomical constraints. By controlling the shape, spacing, and orientation of the flexing points along the wire form, the bending section can achieve customizable stiffness, enhanced load distribution, and improved articulation performance, while maintaining low hysteresis and high durability under repeated bending cycle.

[0052] In an aspect of the present disclosure, a flexible endoscope with improved performance at reduced cost is provided. In some embodiments, a flexible elongate member of the endoscope herein may comprise a composite bending section. The composite bending sectionAttorney Docket No. 55441-733601 may comprise two or more vertebrae components that are linked to one another through one or more wire forms. In some cases, a composite bending section structure may refer to a modular assembly comprising multiple distinct components that are connected or assembled to provide controlled articulation and flexion. The composite bending section structure may comprise vertebrae segments and wire forms, which are assembled to achieve improved mechanical performance while reducing manufacturing cost. An endoscope may comprise a steerable shaft for delivering diagnostics and therapeutics to different parts of a body, where the distal ends of these shafts are commonly steered with tendons (also referred to as pull wires) in one or more directions. Details about the composite bending section are described later herein.

[0053] The composite bending section can be integrated to any articulatable flexible instrument for achieving articulation of a distal end of the flexible instrument or achieving articulation at any desirable segment. The articulatable flexible instrument may be a robotic endoscopic device or a flexible instrument (e.g., needle, grasper, forceps, etc.) that is passed through a robotic endoscopic device. FIG. 11 illustrates an example of a flexible endoscope 1100, in accordance with some embodiments of the present disclosure. As shown in FIG. 11, the flexible endoscope may comprise a handle / proximal portion 1109 and a flexible elongate member to be inserted inside of a subject. In some embodiments, the flexible elongate member may comprise a proximal shaft (e.g., insertion shaft 1101), steerable tip (e.g., tip 1105), and a steerable section (bending section 1103). The bending section 1103 is located between the distal tip 1105 and insertion shaft 1101. The bending section may comprise configurations as described later herein. For example, the bending section may comprise a plurality of vertebrae linked via one or more wire forms. The endoscope 1100 may also be referred to as steerable catheter assembly as described elsewhere herein. In some cases, the endoscope 1100 may be a single-use 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 an instrument driving mechanism and can be disposed of. Unlike conventional endoscopes which often rely on additional guiding elements, such as guide wires to guide the endoscope, or incorporate complex shaft designs, including linked segments or snakelike mechanisms, to successfully navigate tortuous or highly convoluted anatomical passageways, the endoscope apparatus herein may be a substantially single-piece design that is capable of navigating tortuous anatomical passageways without requiring another piece of guiding instrument. The improved bending section herein beneficially allows for the improved articulation performance without requiring additional guiding instruments. In some embodiment, the endoscope may contain varying levels of stiffness along the shaft, as to improve functional operation.Attorney Docket No. 55441-733601

[0054] The endoscope or steerable catheter assembly 1100 may comprise a handle portion 1109 that may include one or more components configured to process image data, provide power, or establish communication with other external devices. For instance, the handle portion may include a circuitry and communication elements that enables electrical communication between the steerable catheter assembly 1100 and an instrument driving mechanism (not shown), and any other external system or devices. In another example, the handle portion 1109 may comprise circuitry elements such as power sources for powering the electronics (e.g., camera, LED lights, or other sensor such as electromagnetic sensor) of the endoscope.

[0055] The one or more components located at the handle may be optimized such that expensive and complicated components may be allocated to the robotic support system, a handheld controller or an instrument driving mechanism thereby reducing the cost and simplifying the design the disposable endoscope. The handle portion or proximal portion may provide an electrical and mechanical interface to allow for electrical communication and mechanical communication with the instrument driving mechanism. The instrument driving mechanism may comprise a set of motors that are actuated to rotationally drive a set of pull wires of the catheter. The handle portion of the catheter assembly may be mounted onto the instrument drive mechanism so that its pulley / capstans assemblies are driven by the set of motors. The number of pulleys may vary based on the pull wire configurations. In some cases, one, two, three, four, or more pull wires may be utilized for articulating the flexible endoscope or catheter.

[0056] The handle portion may be designed allowing the robotic endoscope (e.g., bronchoscope) to be disposable at reduced cost. For instance, classic manual and robotic endoscope may have a cable in the proximal end of the bronchoscope handle. The cable often includes illumination fibers, camera video cable, and other sensors fibers or cables such as electromagnetic (EM) sensors, or shape sensing fibers. Such complex cable can be expensive adding to the cost of the bronchoscope. The provided robotic endoscope may have an optimized design such that simplified structures and components can be employed while preserving the mechanical and electrical functionalities. In some cases, the handle portion of the robotic endoscope may employ a cable-free design while providing a mechanical / electrical interface to the catheter.

[0057] The electrical interface (e.g., printed circuit board) may allow image / video data and / or sensor data to be received by the communication module of the instrument driving mechanism and may be transmitted to other external devices / systems. In some cases, the electrical interface may establish electrical communication without cables or wires. For example,Attorney Docket No. 55441-733601 the interface may comprise pins soldered onto an electronics board such as a printed circuit board (PCB). For instance, receptacle connector (e.g., the female connector) is provided on the instrument driving mechanism as the mating interface. This may beneficially allow the endoscope to be quickly plugged into the instrument driving mechanism or robotic support without utilizing extra cables. Such type of electrical interface may also serve as a mechanical interface such that when the handle portion is plugged into the instrument driving mechanism, both mechanical and electrical coupling is established. Alternatively or in addition to, the instrument driving mechanism may provide a mechanical interface only. The handle portion may be in electrical communication with a modular wireless communication device or any other user device (e.g., portable / hand-held device or controller) for transmitting sensor data and / or receiving control signals.

[0058] In some cases, the handle portion 1109 may comprise one or more mechanical control modules such as lure 1111 for interfacing the irrigation system / aspiration system. Depending on the type of robotic endoscope, the handle portion may comprise fluidics channels for insufflation (e.g., CO2), camera rinse, forward irrigation and / or smoke evacuation. For example, Carbon dioxide (CO2) insufflation may be provided using of CO2 gas to inflate a space, such as the abdomen or digestive tract, for a variety of medical procedures. In some cases, the handle portion may include lever / knob for articulation control. Alternatively, the articulation control may be located at a separate controller attached to the handle portion via the instrument driving mechanism.

[0059] The endoscope may be attached to a robotic support system or a hand-held controller via the instrument driving mechanism (IDM). The instrument driving mechanism may be provided by any suitable controller device (e.g., hand-held controller) that may or may not include a robotic system. The instrument driving mechanism may provide mechanical and electrical interface to the steerable catheter assembly 1100. The mechanical interface may allow the steerable catheter assembly 1100 to be releasably coupled to the instrument driving mechanism. For instance, the handle portion of the steerable catheter assembly can be attached to the instrument driving mechanism via quick install / release means, such as magnets, spring- loaded levels and the like. In some cases, the steerable catheter assembly may be coupled to or released from the instrument driving mechanism manually without using a tool.

[0060] In the illustrated example, the distal tip of the catheter or endoscope shaft is configured to be articulated / bent in two or more degrees of freedom to provide a desired camera view or control the direction of the endoscope. As illustrated in the example, imaging device (e.g., camera), illumination elements (e.g., LED light source) or other optional position sensorsAttorney Docket No. 55441-733601(e.g., electromagnetic sensor) 1107 is located at the tip of the catheter or endoscope shaft 1105. For example, line of sight of the camera may be controlled by controlling the articulation of the bending section 1103. In some instances, the angle of the camera may be adjustable such that the line of sight can be adjusted without or in addition to articulating the distal tip of the catheter or endoscope shaft. For example, the camera may be oriented at an angle (e.g., tilt) with respect to the axial direction of the tip of the endoscope with aid of an optimal component.

[0061] The distal tip 1105 may be a rigid component that allow for various components such as positioning sensors (e.g., electromagnetic (EM) sensors), imaging devices (e.g., camera) and other electronic components (e.g., LED light source) being embedded at the distal tip.

[0062] In the embodiments where the endoscope includes an EM sensor or employ realtime EM tracking, the EM sensor comprising of one or more sensor coils embedded in one or more locations and orientations in the medical instrument (e.g., tip of the endoscopic tool) measures the variation in the EM field created by one or more static EM field generators positioned at a location close to a patient. The location information detected by the EM sensors is stored as EM data. The EM field generator (or transmitter), may be placed close to the patient to create a low intensity magnetic field that the embedded sensor may detect. The magnetic field induces small currents in the sensor coils of the EM sensor, which may be analyzed to determine the distance and angle between the EM sensor and the EM field generator. For example, the EM field generator may be positioned close to the patient torso during procedure to locate the EM sensor position in 3D space or may locate the EM sensor position and orientation in 5DOF (degrees of freedom) or 6DOF (degrees of freedom). This may provide a visual guide to an operator when driving the endoscope towards the target site.

[0063] The endoscope may have a unique design in the elongate member. In some embodiments, the bending section 1103 may comprise composite modular components such as two or more vertebrae linked via one or more wire forms with improved mechanical properties at reduced cost. Details about the bending section are described later herein. In some cases, the proximal shaft of the endoscope may consist of a single tube that incorporates a series of cuts (e.g., reliefs, slits, etc.) along its length to allow for improved flexibility, and a desirable stiffness.

[0064] As described above, the bending section 1103 may be designed to allow for bending in two or more degrees of freedom (e.g., articulation). For example, the bending section may be steered or articulated in up, down, pitch, yaw direction, or any direction in-between. A greater bending degree such as 180 and 270 degrees (or other articulation parameters for clinical indications) can be achieved by the unique structure of the bending section while kinking orAttorney Docket No. 55441-733601 prolapse may be prevented. In some cases, the bending section may be fabricated separately as a modular component and assembled to the proximal shaft.

[0065] The articulation of the endoscope may be controlled by applying force to the distal end of the endoscope via one or multiple pull wires. The 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 orientation of the distal tip to pitch up, down, left, right or any direction needed. In some cases, the pull wires may be anchored at the distal tip of the endoscope, running through the bending section, and entering the handle where they are coupled to a driving component (e.g., pulley). This handle pulley may interact with an output shaft from the robotic system.

[0066] In some embodiments, the proximal end or portion of one or more pull wires may be operatively coupled to various mechanisms (e.g., gears, pulleys, capstans, etc.) in the handle portion of the catheter assembly. The pull wire may be a metallic wire, cable or thread, or it may be a polymeric wire, cable or thread. The pull wire can also be made of natural or organic materials or fibers. The pull wire can be any type of suitable wire, cable or thread capable of supporting various kinds of loads without deformation, significant deformation, or breakage. The distal end / portion of one or more pull wires may be anchored or integrated to the distal portion of the catheter, such that operation of the pull wires by the control unit may apply force or tension to the distal portion which may steer or articulate (e.g., up, down, pitch, yaw, or any direction inbetween) at least the distal portion (e.g., flexible section) of the catheter.

[0067] The pull wires may be made of any suitable material such as stainless steel (e.g., SS316), metals, alloys, polymers, nylons or biocompatible material. Pull wires may be a wire, cable or a thread. In some embodiments, different pull wires may be made of different materials for varying the load bearing capabilities of the pull wires. In some embodiments, different sections of the pull wires may be made of different material to vary the stiffness and / or load bearing along the pull. In some embodiments, pull wires may be utilized for the transfer of electrical signals.

[0068] The proximal design may improve the reliability of the device without introducing extra cost allowing for a low-cost single-use endoscope. In some cases, the device may be a single-use robotic endoscope. The robotic endoscope (e.g., bronchoscope) and can be the same as the steerable catheter assembly as described elsewhere herein. Traditional endoscopes can be complex in design and are usually designed to be re-used after procedures, which require thorough cleaning, dis-infection, or sterilization after each procedure. The existing endoscopes are often designed with complex structures to ensure the endoscopes can endure the cleaning, dis-infection, and sterilization processes. The provided robotic endoscope (e.g., bronchoscope,Attorney Docket No. 55441-733601 colonoscope, gastroscope, etc.) can be a single-use endoscope that may beneficially reduce crosscontamination between patients and infections. In some cases, the robotic endoscope may be delivered to the medical practitioner in a pre-sterilized package and are intended to be disposed of after a single-use.Composite Bending Section

[0069] In an aspect, a bending section for an articulatable instrument is provided. In some embodiments, the bending section may have composite structure comprising one or more wire forms having a substantially alternating square wave pattern two or more vertebrae segments configured to engage the wire form at one or more transitional locations between wave peaks of the square wave pattern. In some embodiments, the wire form may have a substantially alternating square-wave pattern, with defined wave peaks and wave troughs. A vertebra segment may be engaged with a wire form at a transitional location between two wave peaks, facilitating controlled flexion at designated points along the bending section. The vertebra segment may engage the wire form along its outer surface, such as the outer peripheral surface of the vertebra, providing secure coupling while preserving the mechanical integrity of the bending section.

[0070] In alternative embodiments, the wire forms need not be limited to a square-wave pattern. For example, the wire form may have an arc-wave pattern or any other non-square configuration, such as sinusoidal, zigzag, or custom-contoured patterns, to achieve particular bending characteristics or to optimize resistance to tensile and compressive loads. By adjusting the pattern geometry, wave amplitude, and transitional engagement points, the bending section can be tuned to provide specific flexural behavior, improved articulation control, and enhanced durability under repeated bending cycles. Such flexibility in wire form patterning allows the bending section to be adapted for different anatomical or procedural requirements, providing a customizable solution for various medical or surgical applications.

[0071] In some embodiments, an outer jacket in combination with the vertebrae segments serves to capture and retain one or more wire forms at the transitional locations along the bending section. The outer jacket provides radial compression and stabilization, ensuring that the wire forms remain seated within the vertebrae during repeated articulation and under varying tensile or compressive loads. In some embodiments, the wire form may be captured and retained solely by the vertebra segment without requiring an outer jacket, relying on the geometry of the vertebrae or integrated receiving structures such as channels, grooves, or reliefs to maintain positional stability. In other embodiments, the articulatable instrument may comprise an outer jacket, and the wire form may be nested within a relief structure integrally formed in the outer diameter of the vertebra segment. The outer jacket then engages over the vertebra segment andAttorney Docket No. 55441-733601 the wire form, providing additional retention by holding the wire form securely within the relief structure, preventing lateral or rotational displacement during flexion and extension. This arrangement allows for controlled flexure localization, facilitating predictable bending mechanics while maintaining high structural integrity.

[0072] The wire form functions as a link between two consecutive vertebra segments at a designated flexing location, which may correspond to a wave peak, wave trough, or transitional segment of the wire form pattern. The transition segment refers to the portion of the wire form that is captured and retained within a vertebra segment, serving as a structural interface that transmits bending forces while allowing controlled articulation. By localizing flexion to these defined segments, the bending section achieves precise steering, reduced hysteresis, and enhanced resistance to tensile and compressive loads, while the modular nature of the vertebrawire assembly enables customization of flexing points and bending characteristics according to the specific requirements of a surgical or diagnostic procedure.

[0073] FIGs. 1-2 shows an example of a bending section 100, in accordance with some embodiments of the present disclosure. In some embodiments, the bending section 100 may comprise two or more vertebrae (or vertebrae segments) 101 formed of polymer material, biocompatible polymer material composite or elastomer material and the like. The two or more vertebrae may be linked to one another via one or more wire forms 103. The wire form 103 may be configured to couple to the proximal shaft 120 and the tip 110 to continuously link the bending section for compressive and tensile resistance.

[0074] In some embodiments, the wire form may extend into the tip of the steerable device or articulatable instrument to couple the vertebrae to the tip. In some embodiments, the flexible instrument such as an endoscope may comprise a control ring 121. A distal end or portion of one or more pull wires may be anchored or mounted to the control ring, such that operation of the pull wires by the control unit may apply force or tension to the control ring which may steer or articulate (e.g., up, down, pitch, yaw, or any direction in-between) certain section or portion (e.g., distal section) of the catheter. As illustrated in FIG. 3, a distal end of a wire form may be coupled to a control ring 303 located at the distal tip of the flexible instrument. In alternative embodiments, the flexible instrument may not have a control ring whereas the one or more pull wires and the wire form 103 may be terminated at the distal tip 110 individually and directly. For example, distal ends of the one or more pull wires and the wire form may be attached to an integrally formed structure of the distal tip portion such as grooves that are molded with the distal tip.Atorney Docket No. 55441-733601

[0075] In the embodiments where the flexible instrument is an endoscopic device, the bending section may have an internal dimension or structure to accommodate a working channel 131. For instance, the two or more vertebrae 101 may have complicated outer diameter features or eyelet features to facilitate assembly or the organization and segmentation of internals such as working channels, electrical signal cables and the like. Details about the vertebra segment or vertebra are described later herein.

[0076] The vertebrae may be injection molded. The vertebrae may be made of materials such as polymeric material that is low cost and can be fabricated utilizing a low-cost fabrication techniques such as injection molding. In some cases, the materials of the vertebrae 101 of the bending section may be selected such that it may maintain structural support to the internal structures (e.g., working channel) as well as being substantially flexible (e.g., able to bend in various directions and orientations). For example, the vertebrae 101 can be made of any suitable material such as Provista Copolymer, vinyl (such as polyvinyl chloride), Nylon (such as vestamid, grilamid), pellethane, polyethylene, polyurethane, polypropylene, polycarbonate, polyester, silicon elastomer, acetate and so forth. In some embodiments, the one or more vertebrae or vertebra segments are rigid polymer components, the vertebra segment can be formed of any suitable material such as polymer, elastomer or any suitable material such as polyethylene terephthalate (PET), PTFE, pebax, polyurethane, polyamide (PA), or nylon.

[0077] In some embodiments, the rigid polymer vertebrae can be made of a variety of materials including materials with additives such as glass or carbon for increased strength or PTFE for increased lubricity. The material of the vertebrae can be selected such that complicated outer diameter features or eyelet features and internal features may be fabricated using low-cost (e.g., molding) manufacturing methods with reduced cost.

[0078] In some embodiments, the series of elastomer / polymer vertebra segments 101 may comprise a substantially tubular shape with external and internal structures. The internal structures may include, for example, a working channel for passing through tools, cavities or lumens for routing electrical wires, embedded sensors, or other components. Details about the structures of the elastomer / polymer vertebra segments are described later herein.

[0079] The one or more wire forms may be formed of a material that is selected for various purposes. Due to the simple form / structure of the wire form, the materials may be selected from a variety of materials without introducing extra manufacturing / fabrication cost. For example, materials of the wire form may be selected depending on the loading and angular requirements and the material properties. The materials of the wire form may include, without limitation, metallic material such as, stainless steel, nitinol, alloys of NiTi such as NiTiNbY,Attorney Docket No. 55441-733601NiTiCu, NiTiFe, polymers such as PEEK, glass or carbon filled PEEK, Ultem, Poly sulfone and other suitable materials. As an example, the wire form may be formed of materials that may be stiffer or more rigid than the rigid polymer vertebrae to reinforce the bending section at selected locations. In some cases, by selecting the location and / or number of wire forms components in the bending section, a smaller minimum bend radius of bending section may be achieved to facilitate maneuverability of the elongated member, while preventing or reducing the likelihood of kinking or prolapsing. For example, by increasing / decreasing the length of a polymer vertebra section between two wave peaks or wave form peaks, a smaller or greater minimum bend radius may be achieved. For example, the minimum bend radius of the bending section may be varied in a range of 5mm-30mm, a range of 8mm- 15mm or any number below 5mm or above 30mm to allow the bending section to achieve articulation of at least 120-degree, 130-degree, 140-degree, 150-degree, 160-degree, 170-degree, 180-degree, 190-degree, 200-degree or greater. In another example, by adjusting the number of wire forms and location of engaging the wire forms with the vertebra, the number of bending planes or locations of bending planes can be adjusted. Details about the bending planes provided by the wire form design are described later herein.

[0080] As shown in the cross-sectional view of FIG. 2, the assembled bending section may comprise one or more wire forms (e.g., NiTi wire forms) 103 coupled to the vertebrae 101 such as by nesting in receiving structures (e.g., channel, reliefs, grooves, pocket, etc.) formed on the outer surface or diameter of the rigid polymer vertebrae. In some cases, the wire forms may be captured in the receiving structures (e.g., reliefs, channels, grooves, pocket, etc.) and be further held in place by an outer jacket. Alternatively, the wire forms may be captured in the receiving structures and retained in place without an outer jacket. In some embodiments, the wire forms 103 (e.g., NiTi wire forms) may be coupled to the vertebrae 101 by nesting within receiving structures formed on the vertebrae 101, such as channels, grooves, or reliefs on the outer surface or outer diameter, as depicted in FIG. 2. These receiving structures may be precisely dimensioned to accommodate the cross-sectional geometry of the wire forms 103, ensuring a secure fit and alignment along the length of the bending section 100. In some cases, the vertebrae 101 may be formed of a rigid polymer, providing structural stability while maintaining compatibility with the wire form 103. The wire forms 103 may be captured within the receiving structures and further stabilized by an outer jacket positioned over the vertebrae 101, which applies radial compression and retains the wire forms 103 against the vertebrae surface. The combination of the receiving structures and the outer jacket ensures that the wire forms 103 remain properly seated during bending and articulation, prevents lateral or rotational displacement, and contributes to the mechanical integrity and repeatable steering performance of the bending section 100.Attorney Docket No. 55441-733601

[0081] The rigid vertebrae beneficially isolate the flexural loading to one or more desired flexing points in the wire form. Such modular design beneficially provides flexibility to modify the flexing points locations by conveniently adjusting the wire form coupling location.Additionally, the flexing point formed by the continuous wire form provides better flexural loading capability compared to flexing point formed of integral beams of the conventional method. For instance, the switchback nature of the wire form can resist tensile and compressive loads. The flexibility of modifying the flexing point locations may allow for, in some cases, arranging the isolated flexure linearly between vertebrae to more efficiently resist the tensile and compressive loads, and alternatively, arranging the flexures between vertebrae in any non-linear shape (e.g., arc shaped-line) to achieve sufficient resistance to compressive and tensile loads for a particular application. For example, the switchback configuration of the wire form 103 inherently resists both tensile and compressive forces, providing a robust flexing mechanism. The modularity of the system permits the flexing points to be arranged linearly between vertebrae 101, optimizing the bending section's ability to resist axial tensile and compressive loads efficiently. Alternatively, the flexures can be positioned in non-linear arrangements, such as arcshaped lines or zigzag patterns, to tailor the bending characteristics to specific applications or anatomical constraints. By controlling the shape, spacing, and orientation of the flexing points along the wire form 103, the bending section 100 can achieve customizable stiffness, enhanced load distribution, and improved articulation performance, while maintaining low hysteresis and high durability under repeated bending cycles.

[0082] For example, the placement of the wire forms 103 within the reliefs or channels may allow for controlled flexion and torsion, with the geometry of the nesting structures tuned to balance stiffness, flexibility, and spring-back characteristics of the composite bending section 100. The rigid vertebrae 101 beneficially serve to localize flexural loading to one or more predetermined flexing points along the NiTi wire form 103. By constraining flexion to specific points, the modular design allows for precise control over bending behavior and enables adjustable placement of the flexing points by altering the locations at which the wire form 103 is coupled to the vertebrae 101. This combination of modular wire form 103 and vertebra 101 provides advantage over conventional designs in which flexing points are integral to the vertebrae or beams, as the continuous wire form flexures can sustain higher flexural loads and exhibit improved spring-back performance.

[0083] FIG. 3 schematically shows an example 100 of one or more wire forms 103 having a substantially square wave pattern. The wire form provides a link between two consecutive vertebra segments 301-1, 301-2 at a flexing point 103-1, 103-2. The location of the flexing point may be a wave peak 103-1 or wave trough 103-2 of the square wave pattern. InAttorney Docket No. 55441-733601 some cases, the flexing point location may determine a bending plane for the bending section. A bending plane is perpendicular to the bending axis of rotation and intersects the bending section at its full diameter (e.g., intercardinal plane).

[0084] The wire forms can beneficially provide flexibility to increase / decrease the number of bending planes (e.g., multi-planar bending) such as by increasing or decreasing the number of wire forms in the bending section. Additionally, the wire forms can beneficially provide additional flexibility to adjust the angles of bending planes orientation. For instance, the bending section may have multiple bending planes, wherein an angle between bending planes can be adjusted easily by varying locations of the wire forms to allow for any suitable degree of offset (e.g., common 90-degree offset, or less common degree of offset that is not orthogonal). Further, adjusting the angle between the bending planes can beneficially allow for anisotropic bending stiffness, that is the bending section is easier to bend in one intercardinal plane than bending in another lane.

[0085] A bending plane can be determined by the plane that is shared by the links or vertical sections 103-1 or 103-2 of two wire forms. FIGs. 8 and 9 show examples of different bending plane configurations determined by the wire forms pattern and / or locations. As illustrated in the example 800, 910, the bending section may comprise two wire forms where the alternating square wave pattern creates two unique bending planes. As shown in FIG. 9, in some embodiments, the bending section 910 may have two wire forms 915, 917. As illustrated, in between each vertebrae, each wire form extends to the adjacent vertebrae. The virtual plane that bisects the neutral axis of each wire form extension is the bending plane for intervertebral motion.

[0086] A local intervertebral bending plane is created by the plane shared by a pair of local intervertebral wire form extensions symmetrical to the axial axis (i.e., intervertebral bending plane). A common bending plane may be formed by one or more local intervertebral bending planes that are coplanar. In the illustrated example, there are two common bending planes 911, 921. For instance, a common bending plane 911 is formed by the two wire forms 915, 917 shaped to align sequential vertical intervertebral extensions on alternating bending planes 911-1, 911-2, 911-3 and a common bending plane 921 is formed by the two wire forms 915, 917 shaped to align sequential vertical intervertebral extensions on alternating bending planes 921-1, 921-2, 921-3. In the example, the sequential intervertebral bending planes 1 A, IB and 1C 911-1, 911-2, 911-3 are coplanar thus forming a common bending plane 911. However, the intervertebral bending planes do not have to be coplanar across the wire form peaks / troughs.Attorney Docket No. 55441-733601For instance, multiple non-coplanar intervertebral bending planes may form multiple bending planes for the bending section.

[0087] The two common bending planes 911, 921 in the example are orthogonal to one another. The angle or orientation angle between two bending planes can be any angle that is not 90 degrees such that the bending planes may or may not be orthogonal planes. FIG. 8 shows examples of different angles 800, 810 between two bending planes. As shown in the first example 800, the angle 801 between the two common bending planes may be 90 degree. The two bending planes are 90 degrees to one another. Angle 1 + Angle 2 = 180 degree to allow for an intervertebral motion, however, Angle 1 or Angle 2 can be any degree that may or may not be 90 degree. As shown in the second example 810, the angle between the two bending planes 95 degree. When the angle is not 90-degree, the bending section may have anisotropic bending stiffness that is it is easier to bend in the direction defined by the largest of the two angles (e.g., Angle 1 or Angle 2). Thus by varying the location of the wire forms, the bending stiffness of the bending section can be adjusted.

[0088] The number and / or the orientation of the bending planes can be modified by varying the coplanar of the sequential of local intervertebral bending planes as described above, as well as varying the number of wire forms in the bending section. The bending section may comprise at least one, two, three, four, five, six, seven, or more wire forms. The bending section may comprise at least two, three, four, five, six, seven, or more vertebra segments.

[0089] In some embodiments, the bending stiffness of the bending section can be further varied by adopting different shapes of the wire forms. For example, the wave form may have a non-square wave wire form pattern where the peaks and troughs of the wave form an arc. For instance, the wire form may have a substantially alternating arc-shaped wave pattern.

[0090] In some embodiments, the bending stiffness of the bending section can be further fine-tuned by varying a cross-section shape / dimension (e.g., diameter, length, etc.) of the wire form and / or material selection of the wire form. FIG. 4 shows various different cross-sections of a wire form. In some embodiments, the wire form may have a substantially circular cross section 405. Alternatively, the wire form may have any non-circular cross section such as triangular shape 401, rectangular shape 403 or any other shapes.

[0091] The cross-section of the wire form may or may not be constant along the length of the wire form. In some cases, a shape or dimension of the cross section may be modified at locations along the length to change the cross-section locally for the purposes of fixation or retention with the proximal shaft, retention with the vertebrae or distal tip. For example, the distal end, proximal end of the wire form may have a cross-section shaped differently from the rest ofAttorney Docket No. 55441-733601 the wire form to be better fixed to the distal tip portion or proximal shaft portion of the flexible instrument.

[0092] In some cases, the shape of the cross-section may be selected for easy and low- cost fabrication of the wire form. As shown in the example 410, 411, nested wire forms may be manufactured by cutting from a tube of raw material. The example 411 shows three sets of wires are cut from the same axial length of tubing and the cross section of the wire form may be noncircular. As shown in the example 410, laser cut wire forms may be NiTi wire forms that are nested in reliefs provided in the outer diameter of the rigid polymer vertebrae and captured in the reliefs by the outer jacket.

[0093] The “switchback” feature of the wire form may provide improved resistance to tensile and compressive loads. Isolated flexure or link provided by the wire form between consecutive vertebra is linear between the vertebrae thereby improving the efficiency of resisting the tensile and compressive loads. Referring back to FIG. 3, the wire form may be captured and retained by a structure of the vertebra segment at one or more transitional locations 310. As used herein, the term "transitional locations" may refer to specific positions along the wire form where vertebrae segments engage and capture the wire form, typically occurring between wave peaks or at wave troughs of the alternating pattern. These transitional locations serve as controlled flexing points that enable precise articulation while maintaining structural integrity of the bending section. A transitional location refers to the portion of a wire form between adjacent peaks and troughs of a patterned geometry, such as a square-wave or arc-wave configuration. A transitional location may represent the straight or angled segment of the wire form that is received within or engaged by a vertebra. When the transitional location is anchored within a vertebra, flexion is localized to the adjacent peak or trough regions, thereby defining the bending axis and ensuring predictable articulation. Transitional locations may serve as mechanical interfaces between the wire form and vertebrae, transmitting compressive and tensile forces while constraining flexural behavior to designated points.

[0094] The vertebra segments of the bending section may have external features for capturing and retaining the one or more wire forms. For instance, receiving structures (e.g., channel, reliefs, grooves, pocket, etc.) may be formed on the outer surface or diameter of the rigid polymer vertebrae. In some embodiments, the bending section may comprise two or more vertebra segments with two consecutive vertebrae arranged as alternating mirror images to one another. The term "alternating mirror images" may refer to a geometric arrangement where consecutive vertebra segments are oriented as reflections of one another about a plane perpendicular to the longitudinal axis of the bending section. In some cases, this alternatingAttorney Docket No. 55441-733601 pattern may create a configuration where the external receiving structures, such as channels or pockets, are positioned on opposite sides of adjacent vertebrae. For example, if a first vertebra segment has a receiving structure positioned on its upper surface, the immediately adjacent vertebra segment may have its corresponding receiving structure positioned on its lower surface, creating a mirror image relationship.

[0095] This alternating mirror image arrangement may provide several technical benefits for the bending section. In some aspects, the alternating configuration may allow the wire form to follow a switchback pattern that alternates between opposite sides of the bending section, which may enhance the structural resistance to both tensile and compressive loads. In some cases, the alternating arrangement may distribute bending stresses more evenly across the length of the bending section, potentially reducing stress concentrations at individual flexing points.Additionally, the mirror image configuration may facilitate controlled articulation in multiple directions while maintaining the ability to return to a neutral position, thereby improving the spring-back characteristics of the bending section.

[0096] In some embodiments, the alternating mirror image arrangement may also simplify the manufacturing process by allowing the use of complementary tooling or molds for producing the vertebra segments. The alternating pattern may enable the wire form to be captured and retained more securely within the receiving structures, as the switchback configuration may provide multiple points of engagement along the length of the bending section.

[0097] FIG. 7 shows an example 700 of a pair of consecutive vertebrae segments 711, 713 and a wire form component 721 coupled to it. As shown in the example of the vertebrae pair 700, the two vertebrae segments 711, 713 in the pair are “mirrors” of one another. This vertebrae pair (e.g., 301-1, 301-2 of FIG. 3) may be linked by a peak or trough of the wave pattern of the wire form and the alternations between vertebrae pairs form the peaks and troughs of the wave pattern (shown in FIG. 3).

[0098] As shown in FIG. 7, each vertebra segment 711, 713 may be formed with external features such as relief, pocket, groove or other receiving structure 703 to capture and retain a wire form. The receiving structure may be formed on the outer surface of the vertebra segment and upon assembly forming a continuous structured wave pattern to capture a wire form 721.

[0099] In some cases, the wire form may be retained by the receiving structure alone without additional components. For instance, the receiving structure may have hook, tab, and the like allowing the vertebrae to capture the wire form without requiring an outer jacket. In some cases, the dimension or shape of the receiving structure and the wire form may be selected to create an interference fit / friction such that the wire form is captured and retained withoutAttorney Docket No. 55441-733601 additional fasten means. In some cases, other methods such as molding, friction / interference fits, brazing, soldering, welding and the like may be employed to retain the wire form to the vertebra. In some cases, the material of the vertebrae may be selected (e.g., metal material or material that may not be polymer) to be similar to the material of the wire form, to facilitate easier joining of like-to-like materials.

[0100] Alternatively, in some embodiments, one or more wire forms (e.g., NiTi wire forms) may be nested in reliefs formed in the outer diameter of the rigid polymer vertebrae and captured in the reliefs by an outer jacket.

[0101] In optional embodiments, the vertebra segments may further have receiving structures formed on the outer surface / diameter to receive one or more pull wires. For example, one or more channels 701 may be formed on the outer diameter to receive a pull wire. Referring to FIG. 9, in the example 900, the channel 901 for a pull wire may be a substantially straight line formed by a sequence of the linked vertebra pairs.

[0102] As shown in the example, the bending section may have two bending planes created by two wire forms 903 and the articulation of the bending section may be driven by four pull wires. The vertebra segments may be formed with four channels 901 for capturing the four pull wires. The example shows two of the four pull wires run over the transition segment 905 of the wire form. In some cases, the receiving structure for capturing the wire form may have uniform depth. Alternatively, the receiving structure (e.g., relief, groove, channel) for the wire form may be tapered. For instance, the groove for the transition segment 905 may be deeper than the groove towards the edge of the vertebra segment such that the pull wire can run over the wire form without interference.

[0103] The location of the channels / pull wires and the location of the receiving structure for the wire form / bending plane may be selected to adjust different control performance. For instance, the bending planes may be orthogonal to one another and the tendon (pull wire) routing may be orthogonal to one another which may be preferred for control, but complicated for small diameter, densely packed catheter cross-sections due to internals. In some cases, the pull wire routing may not be orthogonal to the wire form location / bending plane. The pull wires (or tendons) and the wire forms may have any relative location so long as they do not share the same plane. For example, the tendons may not be placed within the bending plane formed by the wire forms.

[0104] Alternatively, the bending section may be provided at a passive section of an instrument without steering pull wires / tendons. The composite bending section (vertebrae and wire form combination) may allow the bending section to passively deform to the shape of theAttorney Docket No. 55441-733601 anatomy. In such embodiments, the bending section may or may not have channels or lumen for tendon routing, where the tendon routing supports a function further distal to the passive bending section.

[0105] Referring back to FIG. 7, the vertebra segment may have inner structure comprising at least a lumen 705 for passing through a working channel (e.g., working channel 131). In optional embodiments, the internal lumen 705 may be subdivided to provide additional one or more lumens for routing one or more electrical wires (e.g., cables to supply powers to the sensor, LED, camera, etc. located at the distal tip).

[0106] The internal lumen may or may not have a circular shape. As shown in the example, the internal lumen may have any irregular shape to accommodate various components routed through the flexible instrument.

[0107] In some embodiments, the bending section may comprise a plurality of polymer vertebra segments having identical inner profiles and / or outer profiles (formed into pairs comprising mirrored features). Alternatively, the plurality of individual polymer vertebra segments to form a single bending section may have different inner profiles, and / or lumen configurations. For example, polymer vertebra segments with different length, material, inner profiles, lumen configurations and the like may be selected to form a bending section. This may further vary the wave pattern of the fire form (e.g., vary the pitch or frequency of wave pattern) thereby modifying the bending stiffness along the length of the bending section. As described above, the polymer vertebra segments may be formed of polymer, elastomer or any suitable material such as polyethylene terephthalate (PET), PTFE, pebax, polyurethane, polyamide (PA), or nylon that may or may not be different from material of the wire form. In some cases, an individual polymer vertebra segment may be manufactured by polymer extrusion, molding or other suitable manufacturing methods.

[0108] As described above, the bending section may comprise an outer jacket to retain the one or more pull wires or one or more wire forms. The outer jacket may be formed of polymer or any suitable material such as PTFE, pebax, polyurethane, or nylon. In some cases, a dimension, materials and / or features forming the jacket may be selected to provide a smooth outer layer and / or variable stiffness.

[0109] In some embodiments, the vertebrae segments may also comprise keying features to facilitate the alignment of the proximal shaft and tip. The keying features may be snap fits, interference fits, tapered fits or the like and may aid in resisting some of the loading such as torsional or tensile, along with the wire form. FIG. 5 shows an example 500 of terminating or coupling a proximal end of the wire form to the proximal shaft (e.g., proximal shaft 120). AsAtorney Docket No. 55441-733601 shown in the example, the proximal end vertebrae segment may comprise toothed interaction for alignment with the proximal shaft and provide torsional rigidity 501.

[0110] In some embodiments, the channels for receiving the pull wire or tendon formed on the outer diameter of the polymer vertebrae may capture the tendons between the vertebrae and the outer jacket. The tendon channels may be tapered to eliminate the need for a coil pipe transition component. In some cases, the most proximal vertebrae can be directly coupled to the proximal shaft where the distal end of the coil pipes are terminated and the most distal vertebrae is coupled to the control ring, where the tendons are terminated. FIG. 6 shows an example of the tapered channel for the pull wire for convenient termination at the distal end and proximal end of the bending section.[OHl] In some embodiments, the wire form composite bending section may be active or passive. Additionally or alternatively, the composite bending section may be both active and passive. As an example not by way of limitation, the active section may be articulatable by pull wires whereas a passive bending section may allow coil pipes to traverse the bending structure and isolate pull wire loads to a function distal to the bending section.

[0112] In some embodiments, an active and passive bending section may be configured to terminate coil pipes, for example, at a vertebrae located distally to the proximal end of the wire form, but proximally to the distal end of the wire form where the active bending section is the segment of the wire form distal to the coil pipe termination and the passive bending section is the segment of the wire form proximal to the coil pipe termination.

[0113] In some embodiments, the joint planes may be shared between active and passive bending sections. Additionally or alternatively, the joint planes may be unique between active and passive bending sections, provided the wire form pattern transitions to facilitate a new series of bending planes at the point of transition between active and passive bending sections.

[0114] In some embodiments, the bending section may comprise additional component to further adjust a stiffness of the bending section. For example, an elastomeric washer may be added between each vertebrae pair and / or between any two vertebrae. FIG. 10 shows an example of an additional component 1001 added to a vertebra segment. The additional component may be a washer that is located between two vertebra segments providing several functions including adding stiffness to the overall structure, balancing any stiffness discontinuities that result from the wire form entering or exiting a super-elastic strain region, or restricting access to gaps between the rigid vertebrae during tool passage through the working channel while the bending section is in an articulated state. The elastomeric spacer or washer (formed of silicone or foam) may be used between two rigid vertebrae. In some cases, the elastomeric spacers may beAttorney Docket No. 55441-733601 compressed when the wire form is engaged with the vertebrae stack. The elastomeric space can be placed at any location along the length of the bending section for achieving desired performance of the bending section.Flexible Instrument and Flexible Endoscope

[0115] In some embodiments, the bending section herein may be utilized for improving flexibility and performance of a flexible instrum ent / endoscope without introducing extra cost. The provided bending section may be utilized by any devices or apparatuses including any type of flexible instrument (e.g., needle, grasper, endoscope, etc.) having a bending section. Furthermore, the bending section may be an active bending section pulled by one or more pull wires or a passive bending section without pull wires.

[0116] In an aspect of the invention, a flexible endoscope with improved performance (e.g., improved reliability) at reduced cost is provided. FIG. 11 illustrates an example of a flexible endoscope 1100, in accordance with some embodiments of the present disclosure. As shown in FIG. 11, the flexible endoscope may comprise a handle / proximal portion 1109 and a flexible elongate member to be inserted inside of a subject. In some embodiments, the flexible elongate member may comprise a proximal shaft (e.g., insertion shaft 1101), steerable tip (e.g., tip 1105), and a steerable section (bending section 1103). The bending section 1103 is located between the distal tip 1105 and insertion shaft 1101. The bending section may comprise configurations as described later herein. For example, the bending section may comprise a plurality of vertebrae linked via one or more wire forms. The endoscope 1100 may also be referred to as steerable catheter assembly as described elsewhere herein. In some cases, the endoscope 1100 may be a single-use 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 an instrument driving mechanism and can be disposed of. In some embodiment, the endoscope may contain varying levels of stiffness along the shaft, as to improve functional operation.

[0117] As shown in FIG. 12, a robotic endoscope (e.g., bronchoscope, colonoscope, gastroscope, etc.) 1220 may comprise a handle portion 1213 and a flexible elongate member 1211. In some embodiments, the flexible elongate member 1211 may comprise a shaft, steerable tip, a steerable bending section and an anti-prolapse passive section. The robotic endoscope 1220 can be the same as the steerable catheter assembly as described in FIG. 11. The robotic endoscope may be a single-use 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 endoscope may be released from the instrument driving mechanism and can beAttorney Docket No. 55441-733601 disposed of. In some cases, the endoscope may contain varying levels of stiffness along its shaft, as to improve functional operation. In some cases, a minimum bend radius along the shaft may vary so that the kink resistance capability may be configurable along the length.

[0118] The robotic endoscope can be releasably coupled to an instrument driving mechanism 1220. The instrument driving mechanism 1220 may be mounted to the arm of the robotic support system or to any actuated support system as described elsewhere herein. The instrument driving mechanism may provide mechanical and electrical interface to the robotic endoscope 1210. The mechanical interface may allow the robotic endoscope 1210 to be releasably coupled to the instrument driving mechanism. For instance, the handle portion of the robotic endoscope can be attached to the instrument driving mechanism via quick install / release means, such as magnets and spring-loaded levels. In some cases, the robotic endoscope may be coupled or released from the instrument driving mechanism manually without using a tool.

[0119] FIG. 12 shows an example of an instrument driving mechanism 1220 providing mechanical interface to the handle portion 1213 of the robotic endoscope. As shown in the example, the instrument driving mechanism 1220 may comprise a set of motors that are actuated to rotationally drive a set of pull wires of the flexible endoscope or catheter. The handle portion 1213 of the catheter assembly may be mounted onto the instrument drive mechanism so that its pulley assemblies or capstans are driven by the set of motors. The number of pulleys may vary based on the pull wire configurations. In some cases, one, two, three, four, or more pull wires may be utilized for articulating the flexible endoscope or catheter.

[0120] As shown in FIG. 12, a robotic endoscope (e.g., gastroscope or colonoscope) 1210 may comprise a handle portion 1213 and a flexible elongate member 1211. In some embodiments, the flexible elongate member 1211 may comprise a shaft, steerable tip, a steerable / active bending section and optionally an anti-prolapse passive section. The robotic gastroscope 1210 can be the same as the steerable catheter assembly as described in FIG. 11. The robotic gastroscope may be a single-use 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 gastroscope may be released from the instrument driving mechanism and can be disposed of. In some cases, the gastroscope may contain varying levels of stiffness along its shaft, as to improve functional operation. In some cases, a minimum bend radius along the shaft may vary so that the kink resistance or anti-prolapse capability may be configurable along the length.

[0121] The robotic gastroscope can be releasably coupled to an instrument driving mechanism 1220. The instrument driving mechanism 1220 may be mounted to the arm of theAttorney Docket No. 55441-733601 robotic support system or to any actuated support system as described elsewhere herein. The instrument driving mechanism may provide mechanical and electrical interface to the robotic gastroscope 1210. The mechanical interface may allow the robotic gastroscope 1210 to be releasably coupled to the instrument driving mechanism. For instance, the handle portion of the robotic gastroscope can be attached to the instrument driving mechanism via quick install / release means, such as magnets and spring-loaded levels. In some cases, the robotic gastroscope may be coupled or released from the instrument driving mechanism manually without using a tool.

[0122] FIG. 13 and FIG. 14 show an example of an instrument driving mechanism (TDM) 1320 providing a mechanical interface to the handle portion of the robotic endoscope. In some cases, the IDM 1320 for a robotic endoscope and one or more IDMs for one or more instruments (e.g., surgical instrument) 1331, 1333 may be attached to the robotic arm 1300. As shown in the example, the instrument driving mechanism (IDM) 1320 for the robotic endoscope may comprise a set of motors 1321 that are actuated to rotationally drive a set of pull wires of the flexible endoscope or catheter. The handle portion of the catheter assembly may be mounted onto the instrument drive mechanism 1320 so that its pulley assemblies or capstans are driven by the set of motors. The number of pulleys may vary based on the pull wire configurations. In some cases, one, two, three, four, or more pull wires may be utilized for articulating the flexible endoscope or catheter. Similarly, the instrument driving mechanism (IDM) 1331 for the surgical instrument herein may comprise a set of motors 1335 that are actuated to rotationally drive a set of pull wires of the surgical instrument thereby controlling the articulation of the bending sections of the surgical instrument, the roll movement and suture operation of the needle end effector as described above.

[0123] The handle portion may be designed allowing the robotic gastroscope to be disposable at reduced cost. For instance, classic manual and robotic gastroscopes may have a cable in the proximal end of the gastroscope handle. The cable often includes illumination fibers, camera video cable, and other optional sensor fibers or cables such as electromagnetic (EM) sensors, or shape sensing fibers. Such complex cable can be expensive, adding to the cost of the gastroscope. The provided robotic gastroscope may have an optimized design such that simplified structures and components can be employed while preserving the mechanical and electrical functionalities. In some cases, the handle portion of the robotic gastroscope may employ a cable-free design while providing a mechanical / electrical interface to the catheter.

[0124] FIG. 15 shows an example of a distal tip 1500 of an endoscope. In some cases, the distal portion or tip of the endoscope 1500 may be substantially flexible such that it can be steered into one or more directions (e.g., pitch, yaw). The endoscope may comprise a tip portion,Attorney Docket No. 55441-733601 bending section, and insertion shaft. In some embodiments, the endoscope may have variable bending stiffness along the longitudinal axis direction. For instance, the endoscope may comprise multiple sections having different bending stiffness (e.g., flexible, semi-rigid, and rigid). The bending stiffness may be varied by selecting materials with different stiffness / rigidity, varying structures in different segments (e.g., cuts, patterns), adding additional supporting components or any combination of the above. In some embodiments, the endoscope may have variable minimum bend radius along the longitudinal axis direction. The selection of different minimum bend radius at different locations along the endoscope may beneficially provide anti-prolapse capability while still allowing the endoscope to reach hard-to-reach regions. In some cases, a proximal end of the endoscope needs not be bent to a high degree thus the proximal portion of the endoscope may be reinforced with additional mechanical structure (e.g., additional layers of materials) to achieve a greater bending stiffness. Such a design may provide support and stability to the endoscope. In some cases, the variable bending stiffness may be achieved by using different materials during extrusion of the endoscope. This may advantageously allow for different stiffness levels along the shaft of the endoscope in an extrusion manufacturing process without additional fastening or assembling of different materials.

[0125] The distal portion of the endoscope may be steered by one or more pull wires. The distal portion of the endoscope may be made of any suitable material such as co-polymers, polymers, metals or alloys such that it can be bent by the pull wires. In some embodiments, the proximal end or terminal end of one or more pull wires may be coupled to a driving mechanism (e.g., gears, pulleys, capstan etc.) via the anchoring mechanism as described above. The distal end or portion of one or more pull wires may be anchored or integrated to the distal portion of the endoscope, such that operation of the pull wires by the control unit may apply force or tension to the distal portion which may steer or articulate (e.g., up, down, pitch, yaw, or any direction inbetween) at least the distal portion (e.g., flexible section) of the endoscope.

[0126] The endoscope may have a dimension so that one or more electronic components can be integrated to the endoscope. For example, the outer diameter of the distal tip may range from 3mm to 25 mm, and the diameter of the instrument channels 1301 may range from 2 mm to 6 mm such that one or more instruments can be removably inserted through the endoscope to the surgical site. However, it should be noted that based on different applications, the outer diameter can be in any range smaller than 3 mm or greater than 25 mm, and the diameter of the instrument channels 1301 can be in any range such as about 4 mm or 5 mm to allow the surgical instrument herein passing through. The space not occupied by fluidics or instrument pass throughs can be used to embed electronic components into the wall of the endoscope.Attorney Docket No. 55441-733601

[0127] The one or more electronic components may comprise an imaging device, illumination device or other optional sensors. In some embodiments, the imaging device may be a video camera 1313. The imaging device may comprise optical elements and image sensor for capturing image data. The image sensors may be configured to generate image data in response to wavelengths of light. A variety of image sensors may be employed for capturing image data such as complementary metal oxide semiconductor (CMOS) or 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 comprise a plurality of electronic elements for processing the image signal. For instance, the circuit for a CCD sensor may comprise A / D converters and amplifiers to amplify and convert the analog signal provided by the CCD sensor. Optionally, the image sensor may be integrated with amplifiers and converters to convert analog signal to digital signal such that a circuit board may not be required. In some cases, the output of the image sensor or the circuit board may be image data (digital signals) can be further processed by a camera circuit or processors of the camera. In some cases, the image sensor may comprise an array of optical sensors.

[0128] The illumination device may comprise one or more light sources 1311 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 miniaturized LED for a compact design or Dual Tone Flash LED Lighting.

[0129] The imaging device and the illumination device may be integrated to the endoscope. For example, the distal portion of the endoscope may comprise suitable structures matching at least a dimension of the imaging device and the illumination device. The imaging device and the illumination device may be embedded into the catheter. A camera may be located at the distal portion 1400. The distal tip may have a structure to receive the camera, and illumination device. For example, the camera may be embedded into a cavity at the distal tip of the catheter. The cavity 1410 may be integrally formed with the distal portion of the cavity and may have a dimension matching a length / width of the camera such that the camera may not move relative to the endoscope. The camera may be adjacent to one or more instrument channels 1301 of the endoscope to provide near field view of the tissue or the organs. In some cases, the attitude or orientation of the imaging device may be controlled by controlling a rotational movement (e.g., roll) of the endoscope.

[0130] The power to the camera may be provided by a wired cable. In some cases, the cable wire may be in a wire bundle providing power to the camera as well as illumination elements or other circuitry at the distal tip of the endoscope. The camera and / or light source mayAttorney Docket No. 55441-733601 be supplied with power from a power source located at the handle portion via wires, copper wires, or via any other suitable means running through the length of the catheter. In some cases, real-time images or video of the tissue or organ may be transmitted to an external user interface or display wirelessly. The wireless communication may be WiFi, Bluetooth, RF communication or other forms of communication. In some cases, images or videos captured by the camera may be broadcasted to a plurality of devices or systems. In some cases, image and / or video data from the camera may be transmitted down the length of the catheter to the processors situated in the handle portion via wires, copper wires, or via any other suitable means. The image or video data may be transmitted via the wireless communication component in the handle portion to an external device / system. In some cases, the system may be designed such that no wires are visible or exposed to operators.

[0131] In conventional endoscopy, illumination light may be provided by fiber cables that transfer 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 disclosure, miniaturized LED lights may be employed and embedded into the distal portion of the catheter to reduce the design complexity. In some cases, the distal portion may comprise a structure having a dimension matching a dimension of the miniaturized LED light source. As shown in the illustrated example, two cavities may be integrally formed with the endoscope to receive two LED light sources 1311. For instance, the outer diameter of the distal tip may range from 3mm to 25 mm and diameter of the working channel of the endoscope may be around 4.5 or 6 mm such that two LED light sources may be embedded at the distal end. The outer diameter can be in any range smaller than 3 mm or greater than 25 mm, and the diameter of the instrument channels 1301 can be in any range according to the tool's dimensional or specific application. Any number of light sources may be included. The internal structure of the distal portion may be designed to fit any number of light sources.

[0132] In some cases, each of the LEDs may be connected to power wires which may run to the proximal handle. In some embodiments, the LEDs may be soldered to separated power wires that later bundle together to form a single strand. In some embodiments, the LEDs may be soldered to pull wires that supply power. In other embodiments, the LEDs may be crimped or connected directly to a single pair of power wires. In some cases, a protection layer such as a thin layer of biocompatible glue may be applied to the front surface of the LEDs to provide protection while allowing light emitted out. In some cases, an additional cover may be placed at the forwarding end face of the distal tip providing precise positioning of the LEDs as well as sufficient room for the glue. The cover may be composed of transparent material matching the refractive index of the glue so that the illumination light may not be obstructed.Attorney Docket No. 55441-733601

[0133] The working channel (e.g., instrument channel 1301, auxiliary channel) may be designed to provide protection for the internal components such as flexible instruments (e.g., surgical instrument, forceps, etc.). When flexible instruments pass through a conventional working channel, they may be obstructed by the working channel due to kinking, ovalizing and / or high friction force. The working channel may provide a high hoop strength and a capability of achieving low bend radius. The working channel may also be designed to provide low friction in the inner surface. The surgical instrument as described herein may be passed through the working channel and advanced over the distal tip of the endoscope or retracted back into the working channel.

[0134] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

Atorney Docket No. 55441-733601CLAIMSWHAT IS CLAIMED IS:

1. A composite bending section structure for an articulatable instrument, comprising: a wire form having a substantially alternating square wave pattern; and two or more vertebrae segments configured to engage the wire form at one or more transitional locations between wave peaks of the square wave pattern.

2. The composite bending section structure of claim 1, further comprising an outer jacket positioned over the two or more vertebrae segments, wherein the outer jacket and the two or more vertebrae segments configured to capture and retain the wire form at the one or more transitional locations.

3. The composite bending section structure of claim 1, wherein the two or more vertebrae segments comprise receiving structures formed on an outer surface thereof for capturing and retaining the wire form.

4. The composite bending section structure of claim 3, wherein the receiving structures comprise at least one of channels, grooves, reliefs, or pockets formed on the outer surface of the vertebrae segments.

5. The composite bending section structure of claim 1, wherein the wire form extends into a shaft of the articulatable instrument to couple the bending section to the shaft.

6. The composite bending section structure of claim 1, wherein the wire form extends into a tip of the articulatable instrument to couple the bending section the tip.

7. The composite bending section structure of claim 1, further comprising one or more tendons for controlling a direction and amplitude of bending of the bending section.

8. The composite bending section structure of claim 1, wherein two wire forms are included to create two bending planes.

9. The composite bending section structure of claim 8, wherein the two bending planes are orthogonal to one another.

10. The composite bending section structure of claim 8, wherein the two bending planes are not orthogonal to one another.

11. The composite bending section structure of claim 1, wherein two consecutive vertebrae segments form a pair with alternating mirror images to one another.Attorney Docket No. 55441-73360112. The composite bending section structure of claim 1, wherein the wire form has a substantially circular cross section.

13. The composite bending section structure of claim 1, wherein the wire form has a non-circular cross section to provide an anisotropic bending stiffness such that it is less stiff in a bending plane than out of plane bending.

14. The composite bending section structure of claim 1, wherein a cross section of the wire form is modified at selected locations along the length to change for the purposes of fixation or retention with the shaft, vertebrae or tip.

15. The composite bending section structure of claim 1, further comprising an elastomeric washer positioned between two vertebrae segments.

16. The composite bending section structure of claim 1, wherein the wire form is fabricated from a material selected from the group consisting of NiTi, stainless steel, and metallic alloys17. A composite bending section structure for an articulatable instrument, comprising: a wire form having a substantially alternating arc-shaped pattern; and two or more vertebrae configured to engage the wire form at one or more transitional locations between wave peaks.

18. The composite bending section structure of claim 17, further comprising an outer jacket positioned over the two or more vertebrae segments, wherein the outer jacket and the two or more vertebrae segments configured to capture and retain the wire form at the one or more transitional locations.

19. The composite bending section structure of claim 17, wherein the two or more vertebrae segments comprise receiving structures formed on an outer surface thereof for capturing and retaining the wire form.

20. The composite bending section structure of claim 17, wherein the wire form extends into a shaft of the articulatable instrument to couple the bending section to the shaft.

21. The composite bending section structure of claim 17, wherein the wire form extends into a tip of the articulatable instrument to couple the bending section the tip.

22. The composite bending section structure of claim 17, further comprising one or more tendons for controlling a direction and amplitude of bending of the bending section.Attorney Docket No. 55441-73360123. The composite bending section structure of claim 17, wherein two wire forms are included to create two bending planes.

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