Systems and methods for robotic endoscope shafts

Abstract

An articulating flexible endoscope is provided that includes an elongate member extending between a distal end and a proximal end, the elongate member including an active bending section steerable by one or more pull wires and a passive section located between the active bending section and the proximal shaft section, the passive section including an anti-retraction structure that defines a minimum bend radius of the passive section.

Description

[Technical field]

[0001] (References)

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 294,304, filed December 28, 2021, and U.S. Provisional Patent Application No. 63 / 373,800, filed August 29, 2022, each of which is incorporated by reference in its entirety into this specification. [Background technology]

[0002]

[0002] Endoscopy procedures use endoscopes to examine the inside of hollow organs or cavities of the body. Unlike many other medical imaging techniques, the endoscope is inserted directly into the organ. Flexible endoscopes, which allow intuitive steering and control, are useful in diagnosing and treating diseases that are accessible through any natural orifice of the body. Depending on the clinical indication, the endoscope may be designated as a bronchoscope, ureteroscope, colonoscope, gastroscope, otolaryngoscope, and various others. For example, flexible bronchoscopes may be used for lung cancer diagnosis and / or surgical treatment. However, one challenge in bronchoscopy is reaching the upper lobes of the lungs while navigating the airways. In another example, flexible endoscopy is used to examine and treat gastrointestinal (GI) tract disorders without the need to create an opening in the patient's body. The endoscope is introduced into the upper or lower GI tract, respectively, through the mouth or anus. A miniature camera at the distal end captures images of the GI wall, which helps clinicians diagnose GI diseases. Simple surgical procedures (such as polypectomy and biopsy) can be performed by introducing a flexible tool through the working channel to reach the site of interest at the distal end. As the segments of the elongated device curve as they move through one or more passageways, the curved segments undergo compression. The compression causes the elongated device to bend and contact the walls of one or more passageways along its length. In areas with one or more large passageways around the elongated device, when the distal end of the device encounters tissue resistance, the elongated device may bend within the large airway and move toward an unintended area rather than the intended direction of the anatomy ("deviation"). Deviation is more likely when tissue resistance is higher (e.g., due to airways that are too small, lungs not fully inflated, diseased tissue, blind insertion, etc.). Deviation or kinking can result in potential damage as it can expose sharp edges of the kinked elongated device and complicate the surgical procedure.

[0003]

[0003] Endoscopes are traditionally made reusable, which may require extensive cleaning, disinfection, and / or sterilization after each procedure. In most cases, cleaning, disinfection, and sterilization may be aggressive processes to kill pathogens and / or bacteria. Such procedures may also be harsh on the endoscope itself. Thus, the design of such reusable endoscopes may often be complex, especially to ensure that the endoscope can withstand such harsh cleaning, disinfection, and sterilization protocols. Regular maintenance and repairs may often be required for such reusable endoscopes.

[0004]

[0004] For instruments that are difficult to clean properly, low-cost disposable medical devices designated for single use are becoming more prevalent. Single-use disposable devices can be packaged in a sterile wrapper to avoid the risk of pathogenic cross-contamination of diseases such as HIV, hepatitis, and other pathogens. Hospitals generally welcome the convenience of single-use disposable products because they no longer have to worry about product lifespan, overuse, breakage, failure, and sterilization. Conventional endoscopes often include a handle that the surgeon uses to operate the endoscope. For single-use endoscopes, the handle usually encapsulates a camera, expensive electronics, and mechanical structures at the proximal end to transmit video and allow the user to operate the endoscope through a user interface. This can lead to a high cost of the handle for single-use endoscopes. Summary of the Invention

[0005]

[0005] Recognized herein is a need for a robotic endoscope that allows for performing surgical or diagnostic procedures with improved performance and cost efficiency. Also recognized herein are devices and systems that include an endoscope that may be disposable and may not require extensive cleaning procedures. The present disclosure provides a low-cost, single-use, articulatable endoscope for diagnosis and treatment in a variety of applications, such as bronchoscopy, urology, gynecology, arthroscopy, orthopedics, ENT, gastrointestinal endoscopy, neurosurgery, and various others. In some embodiments, the present disclosure provides a single-use, disposable, robotically controlled bronchoscope that can be used with a robotic system to enable diagnostic evaluation of lesions anywhere within the pulmonary anatomy. It should be noted that the provided endoscopic systems may be used in a variety of minimally invasive surgical, therapeutic or diagnostic procedures involving various types of tissue, including heart, bladder, and lung tissue, as well as in other anatomical regions of a patient's body, such as the digestive system, including but not limited to the esophagus, liver, stomach, colon, urinary tract, or the respiratory system, including but not limited to the bronchi, lungs, and various others.

[0006]

[0006] The present disclosure provides methods and devices that can improve the performance of an articulating flexible endoscope when navigating a body cavity. A flexible elongate member can be negotiated through an airway / channel with improved anti-slip capabilities. In one aspect of the present disclosure, an articulating flexible endoscope is provided. The endoscope includes an elongate member extending between a distal end and a proximal end, the elongate member including an active bending section steerable by one or more pull wires and a passive section located between the active bending section and the proximal shaft section, the passive section including an anti-slip structure that determines a minimum bend radius of the passive section, thereby preventing slippage.

[0007] In some embodiments, the distal end is connected to a distal tip portion of an articulating flexible endoscope, the distal tip portion comprising a structure for receiving an imaging device, a position sensor, and an illumination device. In some embodiments, the proximal end is connected to a proximal portion of an articulating flexible endoscope, the proximal portion comprising a drive mechanism for applying force to the one or more pull wires.

[0008] In some embodiments, the anti-retraction structure is integrally formed within the passive section. In some cases, the anti-retraction structure comprises a cut pattern, and the minimum bend radius is determined at least in part based on a gap size of the cut pattern. In some examples, the cut pattern comprises gaps and interlocking features.

[0009] In some embodiments, the passive section has two or more different minimum bend radii. In some cases, the anti-departure structure comprises a cut pattern, and the two or more different minimum bend radii are determined by selecting different gap sizes and / or by selecting cut patterns with different pitches.

[0010] In some embodiments, the minimum bend radius of the active bending section is less than the minimum bend radius of the passive section. In some cases, the active bending section has two or more different minimum bend radii.

[0011]

[0011] In some embodiments, the articulating flexible endoscope further comprises one or more coil pipes having a distal end secured to an interface between the passive section and the active bending section. In some cases, the proximal end of the one or more coil pipes is secured to a handle of the articulating flexible endoscope. In some embodiments, the articulating flexible endoscope further comprises a jacket as an outer layer of the elongate member. In some cases, the jacket comprises multiple layers and has a variable stiffness along the length of the jacket. In some embodiments, the proximal shaft section has a stiffness greater than the stiffness of the passive section.

[0012] In another aspect, a method of preventing slippage or kinking of an articulating flexible endoscope is provided comprising: providing an elongate member, steering an active bending section of the elongate member via one or more pull wires to move the articulating flexible endoscope through a passageway, and providing a passive section located between the active bending section and the proximal shaft section, the passive section comprising an anti-slip structure that determines a minimum bend radius of the passive section, thereby preventing slippage while the articulating flexible endoscope is being passed through the passageway.

[0013]

[0013] In some embodiments, the anti-skid structure is integrally formed within the passive section. In some embodiments, the anti-skid structure comprises a cut pattern including repeated gap features and interlocking features. In some cases, the minimum bend radius is determined based at least in part on the gap size of the gap features. In some embodiments, the passive section has two or more different minimum bend radii. In some cases, the anti-skid structure comprises a cut pattern, and the two or more different minimum bend radii are determined by selecting different gap sizes and / or by selecting cut patterns with different pitches.

[0014] In some embodiments, the active bending section has a minimum bend radius that is smaller than the minimum bend radius of the passive section. In some embodiments, the active bending section has two or more different minimum bend radii.

[0015]

[0015] It should be noted that the various components of the provided modular endoscopic components and devices may be used in a variety of minimally invasive surgical, therapeutic or diagnostic procedures involving various types of tissue, including heart, bladder, and lung tissue, as well as in other anatomical regions of a patient's body, such as the digestive system, including but not limited to the esophagus, liver, stomach, colon, urinary tract, or the respiratory system, including but not limited to the bronchi, lungs, and various others.

[0016]

[0016] Further aspects and advantages of the present disclosure will become readily apparent to those skilled in the art from the following detailed description, in which only exemplary embodiments of the present disclosure are shown and described. As will be understood, the present disclosure is susceptible to other and different embodiments, and its several details are susceptible to modification in various obvious respects, all without departing from the present disclosure. Thus, the drawings and description should be regarded as illustrative in nature, and not restrictive.

[0017] (Incorporated by reference)

[0017] All publications, patents, and patent applications mentioned in this specification are hereby 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 that the publications and patents or patent applications incorporated by reference conflict with the disclosure contained herein, the specification is intended to supersede and / or take precedence over any such conflicting material. [Brief description of the drawings]

[0018]

[0018] 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 referred to herein as "Figures" and "FIG.").

[0019] [Figure 1]

[0019] An example of a patient's luminal network is illustrated diagrammatically. [Diagram 2]

[0020] 1 shows an example of a flexible elongate member that passes through an airway / channel with improved anti-misplacement capabilities. [Diagram 3]

[0021] 1 illustrates an example of an elongated member of an endoscope having anti-dislodgement features. [Figure 3A]

[0022] An example of integrating a coilpipe into a medical device is shown. [Figure 3B]

[0023] 1 shows an example of a jacket applied over a catheter. [Figure 3C]

[0024] 1 shows an example of a jacket with multiple compartments. [Figure 4]

[0025] 1 shows an example of different minimum bend radii for active and passive bending sections. [Diagram 5]

[0026] 1 shows different examples of anti-excursion passive section features. [Figure 6]

[0026] Different examples of features of the anti-excursion passive section are shown. [Figure 7]

[0027] 1 shows an example of an active bending section. [Figure 8]

[0028] 1 shows an example of an active bending section with two distinct minimum bending radii. [Figure 9]

[0029] 1 shows an example of a bent section having a uniform minimum bend radius. [Figure 10]

[0030] 1 illustrates an example of a flexible endoscope according to some embodiments of the present disclosure. [Figure 11]

[0031] 1 illustrates an example of a robotic bronchoscope that includes a handle portion and a flexible elongated member. [Figure 12]

[0032] 1 illustrates an example of an instrument drive mechanism that provides a mechanical interface to a handle portion of a robotic bronchoscope. [Figure 13]

[0033] 1 shows an example of a distal tip of an endoscope. [Figure 14]

[0034] 1 shows an example of a distal portion of a catheter having integrated imaging and illumination devices. [Figure 15]

[0035] 1 shows an example of a working channel. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020]

[0036] While various embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the present invention described herein may be employed.

[0021]

[0037] The embodiments disclosed herein can be combined in one or more of many ways to provide improved diagnosis and treatment to patients. The disclosed embodiments can be combined with existing methods and devices to provide improved care, such as, for example, in combination with known methods of pulmonary diagnosis, surgery, and surgery of other tissues and organs. It is understood that any one or more of the structures and steps described herein can be combined with any one or more additional structures and steps of the methods and devices described herein, and the figures and supporting text provide a description according to the embodiments.

[0022]

[0038] While the exemplary embodiments are directed primarily to devices or systems for bronchoscopy, those skilled in the art will understand that this is not intended to be limiting and that the devices described herein may be used for other therapeutic or diagnostic procedures and in various anatomical regions of a patient's body. The devices or systems provided may be utilized with endoscopes, combined devices including endoscopes and instruments, endoscopes with localization capabilities, in urology, gynecology, rhinology, otology, laryngoscopy, gastroenterology, and those skilled in the art will understand that this is not intended to be limiting and that the devices described herein may be utilized for other therapeutic or diagnostic procedures and in the treatment of soft tissues, such as the brain, heart, lungs, intestines, eyes, skin, kidneys, liver, pancreas, stomach, uterus, ovaries, testes, bladder, ears, nose, mouth, bone marrow, adipose tissue, muscle, glandular and mucosal tissue, spinal cord and nerve tissue, biological hard tissues, such as cartilage, teeth, bone, and the like. It will be appreciated that the scope may be used in other anatomical areas of a patient's body, such as body cavities and passageways, such as the sinuses, ureters, colon, esophagus, lung passageways, blood vessels, and throat, as well as various others, in combination with various tools or instruments in the form of neuroendoscopes, encephaloscopes, ophthalmoscopes, otoscopes, rhinoscopes, laryngoscopes, gastroscopes, esophagoscopes, bronchoscopes, thoracoscopes, pleuroscopes, angioscopes, mediastinoscopes, nephroscopes, gastroscopes, duodenoscopes, CholeodoScopes, cholangioscopes, laparoscopes, AmioScopes, ureteroscopes, hysteroscopes, cystoscopes, rectoscopes, colonoscopes, arthroscopes, salivary gland endoscopes, orthopedic endoscopes, and others.

[0023]

[0039] The systems and devices herein can be combined in one or more of many ways to provide improved diagnosis and treatment to patients. The systems and devices provided herein can be combined with existing methods and devices to provide improved care, such as, for example, in combination with known methods of pulmonary diagnosis, surgery, and surgery of other tissues and organs. It is understood that any one or more of the structures and steps described herein can be combined with any one or more additional structures and steps of the methods and devices described herein, and the figures and supporting text provide a description according to the embodiments.

[0024]

[0040] Whenever the terms "at least," "greater than," or "greater than or equal to" precede the first number in a series of two or more numbers, the terms "at least," "greater than," or "greater than or equal to" apply to each and every number in the series. For example, 1, 2, or 3 or more is equal to 1 or more, 2 or more, or 3 or more.

[0025]

[0041] Whenever the terms "not greater than," "less than," or "less than or equal to" precede the first number in a series of two or more numbers, the terms "not greater than," "less than," or "less than or equal to" apply to each and every number in the series. For example, 3, 2, or 1 or less is equivalent to 3 or less, 2 or less, or 1 or less.

[0026]

[0042] As used herein, the terms distal and proximal may refer to locations generally referenced from the device and may be as opposed to anatomical references, for example, a distal location of a primary shaft or catheter may correspond to a proximal location of a patient's elongate member and a proximal location of a primary sheath or catheter may correspond to a distal location of a patient's elongate member.

[0027] Passive deviation prevention section

[0043] As mentioned above, one challenge in bronchoscopy is navigating the airways to reach the upper lobes of the lungs. Figure 1 shows a schematic of an example of a patient's luminal network 100. In the illustrated embodiment, the luminal network 100 is a bronchial network of airways (i.e., lumens, branches) of the patient's lungs.

[0028]

[0044] Accessing the periphery of the right upper lobe 101 of the lung through the apical segment (Ap) has been a challenge with conventional bronchoscopes. In the example 200 shown in FIG. 2, the sharp 180 degree angle between the trachea and Ap, coupled with the large space at the junction of the bronchus intermedius, right main bronchus, and right upper lobe bronchus, can cause the bronchoscope to kink and / or deviate 201 downward through the bronchus intermedius. When a segment of the elongated device curves as it travels through one or more passageways, the curved segment undergoes compression. The compression causes the elongated device to bend and contact the walls of one or more passageways along its length. In areas with one or more large passageways around the elongated device, when the distal end of the device encounters tissue resistance, the elongated device can bend within the large airway and move toward an unintended area of ​​the anatomy rather than the intended direction, known as deviation. Deviation is more likely when tissue resistance is higher (e.g., due to airways that are too small, lungs not fully inflated, diseased tissue, blind insertion, etc.).

[0029]

[0045] The illustrated lumen network is a bronchial network of airways in a patient's lungs, but the disclosure is not limited to only the illustrated example. Deviation or kinking can occur when a flexible elongate member passes through any area within a subject. Deviation or kinking can result in potential damage as it can expose sharp edges of the kinked elongate device and complicate the surgical procedure. A bent or kinked elongate device can also cause the system to lose control of the device's location / shape and can impede the passage of instruments. Furthermore, a device that deviates or kinks may not provide sufficient reach toward the target anatomical structure to perform the intended task. Current methods to solve the kink / deviation problem may include detecting deviation, using shape or force sensing to predict when deviation may occur, or using an outer sheath to provide kink resistance (a steerable outer sheath with sufficient stiffness to not kink and an endoscope or a placed working channel is placed inside the outer sheath and extended across the outer sheath to reach the area). However, such methods require additional components, complicate the device, or compromise the ability to reach hard-to-reach body cavities and ducts.

[0030]

[0046] The present disclosure provides methods and systems for effectively preventing prolapse or kinking without the need for extra sensors or additional elements. The anti-prolapse shaft designs, systems, and methods described herein may be used to navigate any type of luminal network, such as bronchial networks, renal networks, cardiovascular networks (e.g., arteries and veins), gastrointestinal tracts, urinary tracts, etc., as described elsewhere herein.

[0031]

[0047] In one aspect of the present disclosure, a flexible endoscope with improved performance and reduced cost is provided. The flexible elongated members of the endoscope herein may have anti-slip capabilities that allow the elongated members to reach hard-to-reach body cavities and conduits. FIG. 2 shows an example 210 of a flexible elongated member passing through an airway / channel with improved anti-slip capabilities. As illustrated in example 210, the improved anti-slip capabilities may allow the elongated members to achieve superior reach compared to examples without such anti-slip features. The ability of the elongated members to reach hard-to-reach body cavities and conduits without kinking or slipping may be constrained by a minimum bend radius 211.

[0032]

[0048] In some embodiments, the flexible elongate member may comprise multiple sections, including an active steerable / bending section, a passive section, and a proximal shaft. The passive section may be formed with a unique structure that provides a minimum bending radius to prevent deviation / kinking. Such a passive section may advantageously provide deviation resistance and allow for improved ability to reach the periphery of the lungs 210 compared to a conventional bronchoscope as shown in Example 200. As shown in Example 210, when the bronchoscope is pushed through a tortuous path, the passive section may advantageously form a "bridge" configuration 211 across a large space in the right main bronchus to resist deviation into the intermediate bronchus. In contrast, the conventional device of Example 200 without such deviation prevention passive section may kink or deviation 201 when moving through the same passageway.

[0033]

[0049] FIG. 3 shows an example of an endoscopic elongate member 300 having anti-slip features. In some embodiments, the flexible elongate member may include multiple sections, including an active steerable / bending section 303, a passive section 305, and a proximal shaft 307. The flexible elongate member may include a steerable tip 301 located at the distal end of the active bending section. More details about the distal tip are provided later in this specification. The elongate member may include optional other components, such as a coil pipe 309 secured to the distal end of the passive section and the proximal end of the proximal shaft 307 to prevent unintended movement of the shaft during articulation of the bending section. The coil pipe may beneficially prevent a muscling phenomenon. In some cases, tensioning tendons to articulate the distal tip may result in undesired bending and torque along the entire length of the flexible instrument, referred to as "muscling" and "curve alignment." More details about the coil pipes are provided later in this specification.

[0034]

[0050] As shown in FIG. 3, multiple segments may be disposed along the length of the elongate member from the distal end to the proximal end. The anti-slip passive segment 305 may be connected to the active bending segment at a first end and to the proximal shaft 307 at a second end. Although three segments are shown in the example, in some embodiments, the elongate member may include more or fewer segments. For example, the elongate member may include one, two, three, four, five, six, seven, or more segments. The elongate member may also include any number of anti-slip passive segments. For example, there may be two or more passive segments having an anti-slip mechanism.

[0035]

[0051] The passive section may include a mechanism for limiting the minimum bend radius of the passive section, thereby preventing deviation. The minimum bend radius may be defined or determined by the construction of the passive section. In some embodiments, the minimum bend radius of the passive section may be greater than the minimum bend radius of the active bending section 303.

[0036]

[0052] FIG. 4 shows an example of different minimum bending radii for active and passive bending sections. As shown in the example, the minimum bending radius 401 (R1 min ) is the minimum bending radius (R2 min ) 403. Different minimum bend radii of the active bending section and the passive section beneficially facilitate maneuverability of the elongate member while preventing or reducing the possibility of kinking or deviation. Alternatively, the minimum bend radius of the active bending section may be substantially the same as or larger than the minimum bend radius of the deviation prevention passive section, depending on the tortuosity, curvature, or size of the passageway or other requirements.

[0037]

[0053] The smaller minimum bending radius (R1 min ) 401 may facilitate alignment of the tip with airways in tight spaces or with sharp bends. For example, the minimum bending radius (R1 min ) may be in the range of 5 mm to 30 mm, in the range of 8 mm to 15 mm, or any number less than 5 mm or greater than 30 mm. This minimum bend radius may allow the active bending section to achieve at least 120 degrees, 130 degrees, 140 degrees, 150 degrees, 160 degrees, 170 degrees, 180 degrees, 190 degrees, 200 degrees, or more of articulation.

[0038]

[0054] In some cases, the relatively large minimum bending radius (R2 min ) 403 may help fill the gap in the right main bronchus and / or prevent deviation. min ) 403 may be in the range of 1 cm to 3 cm, or any number less than 1 cm or greater than 3 cm. In some cases, the minimum bending radius of the passive section may be determined based on the curvature or size of the patient's internal passageway. For example, the minimum bending radius (i.e., radius of curvature) of the passive section (e.g., R 405) may be greater than or substantially equal to the size of the gap X 407 of the right main bronchus.

[0039]

[0055] In some embodiments, the mechanism for limiting the minimum bend radius of the passive section may comprise an integrally formed mechanical feature (e.g., a cut pattern) that prevents the passive section from further bending beyond the minimum bend radius. Details regarding the mechanical features or structures are described in connection with Figures 5 and 6. By varying the size, shape, or other design of the structures, the devices herein allow improved flexibility to configure the minimum bend radius of selected sections or locations along the elongate member. For example, by selecting the size, shape, or size of the mechanical feature formed at the selected location of the passive section, the minimum bend radius 405 (i.e., radius of curvature) of the passive section may be greater than or substantially equal to the size of the gap X407 of the right main bronchus.

[0040]

[0056] Referring back to FIG. 3 , the minimum bend radius of the active bending section 303 and the anti-departure passive section 305 may be different. In some cases, different minimum bend radii may be defined by varying the mechanical characteristics (e.g., cut pattern) of the active bending section and / or the passive section. In some cases, the active bending section and the passive section may be formed of the same material (e.g., stainless steel), while the minimum bend radius may be different by varying the cut pattern. For example, different minimum bend radii may be achieved by selecting the gap size (gap width) and / or pitch of the repeated cut pattern. For example, a larger gap size, such as a larger gap width, may correspond to a smaller bend radius, and a smaller pitch of the repeated cut pattern (i.e., repeated gaps) may correspond to a smaller bend radius.

[0041]

[0057] The materials of the active bending section or the passive section may or may not be the same. For example, the materials of the active bending section and / or the passive section may include metallic materials such as stainless steel or Nitinol, rigid polymers such as PEEK, glass-filled PEEK, or carbon-filled PEEK, Ultem, polysulfone, and other suitable materials. In some cases, a material may be selected that allows for easier manufacturing (e.g., laser cut patterns), thereby reducing fabrication costs.

[0042]

[0058] The stiffness of the active bending section and the passive section may or may not be the same. In some cases, the stiffness of the active bending section or the passive section may be substantially the same while the minimum bend radius is different. For example, when the bending has not reached the minimum bend radius, the stiffness of the active and passive sections may be substantially the same. Alternatively, the stiffness of the active bending section, the passive section, and the proximal shaft may be different. For example, the section located more proximally (e.g., the proximal shaft 307) may be stiffer to provide pushability to the elongated member 300. In some cases, each section may be configured to provide different flexibility or bending stiffness to facilitate the medical procedure and / or improve the drivability and control of the elongated member 300. For example, the active bending section 303 may provide steerability to the distal end of the bronchoscope with the smallest minimum bend radius. The passive section 305 may provide sufficient flexibility to advantageously follow the active bending section into the periphery or upper lobes of the lung, for example, in the case of bronchoscopy. The passive section 305 may further include an anti-retraction mechanism as described above to prevent kinking. The proximal shaft section 307 may be flexible enough to be inserted into the patient through an introducer, but pushable / rigid enough to provide support for the elongate member, while the outer portion of the proximal shaft is rigid enough to remain outside the patient during the procedure (e.g., does not enter the introducer) and provide support for the entire elongate member 300.

[0043]

[0059] The length of the multiple segments may be selected depending on the application or requirements of use. For example, the active bending segment may be about 40-90 mm in length, or approximately 50 mm. The passive segment may be about 50 mm-150 mm, or approximately 80 mm. The proximal shaft segment may be about 500 mm-1000 mm, or approximately 770 mm. The length of the different segments may vary depending on the type of medical application / device or other factors.

[0044]

[0060] As discussed above, in some embodiments of a passive section, the minimum bend radius of the passive section may be defined or determined by an integrally formed structure of the passive section. In some embodiments, the structure may be a cut pattern formed on the substantially tubular component. In some cases, the cut pattern may comprise features / structures such that different minimum bend radii may be achieved by varying the gap size and / or pitch of the features.

[0045]

[0061] 5 and 6 show different examples of anti-slip passive section features. FIG. 5 shows an example of a "ball-and-socket" cut pattern 500. This cut pattern may include multiple repeated gaps 501 and pivot feature 503. As illustrated in this example, the minimum bend radius may be reached when the gaps 501 are closed at the inner curve, thereby preventing the passive section from bending further. In some cases, the bend radius at which all gaps at the inner curve are closed may be defined as the minimum bend radius. The pivot feature 503 may also help prevent slippage or kinking by an interlocking configuration formed at the outer curve. In some cases, kinking or slippage may occur when the minimum bend radius is less than a certain threshold (e.g., to achieve better flexibility or degree of bending). The gap size and / or pitch of the repeated pattern may be selected to achieve a minimum bend radius above a threshold. In some cases, the minimum bend radius threshold may be determined based on empirical data (e.g., experimental data) and / or simulation results.

[0046]

[0062] 6 shows an example of a continuous spiral cut pattern 600 with interlocking features 601. The cut pattern may include multiple gaps 603 and interlocking features 601. As illustrated in this example, the minimum bend radius may be reached when at the inner curve the gaps close, thereby preventing the passive section from bending further, while at the outer curve the interlocking features contact or form a locking configuration. It should be noted that the example cut pattern is for illustrative purposes only, and any other cut pattern may be used. As mentioned above, the gaps, interlocking features, or pivot features may be formed using any suitable manufacturing method, including, but not limited to, laser cutting, molding, machining, etc.

[0047]

[0063] The cut patterns of the active, passive, and proximal bending sections may be different. In some cases, the cut pattern of the passive section may allow isotropic bending, and features such as gaps and interlocking features may effectively prevent kinking as described above. In some cases, a different cut pattern (e.g., a braided structure) may be employed for the proximal shaft to provide high axial and torsional stiffness and greater control over the stiffness profile. The proximal shaft section may prevent kinking or prolapse due to the greater stiffness of the section. Such integrally formed features (cut patterns) advantageously prevent kinking or prolapse without the need for additional components.

[0048] Active bending section

[0064] 7 shows an example of an active bending section 701. In some embodiments, the active bending section may include an internal structure, such as an eyelet structure 703, for threading multiple pull wires 705. As shown in this example, the pull wires 705 may run through a series of eyelet structures along the length of the bending section. The eyelet structures may be integrally formed with the active bending section on its inner surface to hold the pull wires in place while allowing relative axial movement of the pull wires.

[0049]

[0065] As shown in this example, the cut pattern of the active bending section may be different than the cut pattern of the passive section. For example, the gaps 707 of the active bending section may be larger than the gaps of the passive section, thereby allowing a smaller minimum bend radius. Additionally or alternatively, the pitch of the pattern of the active bending section may be smaller than the pitch in the passive section. In some cases, the internal grommet structures may be formed with the same pitch as the cut pattern. The smaller pitch of the grommet structures may beneficially prevent kinking of the tension wire when the tension wire is placed inside a series of grommet structures.

[0050]

[0066] In some embodiments, in addition to or instead of having a constant minimum bend radius in an active or passive section, a variable minimum bend radius may be provided. For example, an active bending section may have two or more bend radii. As an example, the minimum bend radius of an active bending section may increase from the distal end to the proximal end. The change in the minimum bend radius may be gradual or discrete. FIG. 8 shows an example of an active bending section with two distinct minimum bend radii R1, R2 (R2>R1). The change in the minimum bend radius may be achieved by changing the cutting pattern. For example, the minimum bend radius may be increased by decreasing the gap size or increasing the pitch of the cutting pattern.

[0051]

[0067] FIG. 9 shows an example of a curved section with a uniform minimum bend radius R1. In some cases, kinking or deviation may occur when the minimum bend radius is less than a certain threshold (e.g., to achieve better flexibility or degree of bending). As shown in example 901, when the minimum bend radius is below the threshold, the stress concentration increases in that area, making it more prone to kinking and deviation. In some embodiments, the overall length and minimum bend radius may vary along the length of the elongated member. In some cases, a certain laser cut structure (e.g., the same "dogbone" shape) may be applied to the entire section, while the size / dimensions of the pattern (e.g., pitch, gap size) may vary to change the minimum bend radius. Alternatively or additionally, the pattern may also vary along the length of the elongated member.

[0052]

[0068] As mentioned above, in some embodiments, the elongated member may include optional other components, such as coil pipes secured to the distal end of the passive section and the proximal end of the proximal shaft, to prevent unintended movement of the shaft during articulation of the bending section. The coil pipes may advantageously prevent muscularization. FIG. 3A shows an example of integrating coil pipes into a medical device. In some cases, at least one, two, three, four, five, or more coil pipes may be included to reduce axial compression / extension (deformation) of the elongated member during articulation of the bending section. The coil pipes may transmit at least a portion of the articulation loads applied to the active bending section and / or shaft back to the handle (e.g., via an actuator or motor driving one or more articulating pull wires).

[0053]

[0069] The coil pipes may counteract articulation loads and allow for improved stability of the proximal shaft and the anti-slip passive section. A plurality of coil pipes 309 may reside within the inner lumen (i.e., tube bore) of the shaft tube and the passive section and may be configured to transmit articulation reaction forces from the flex section to the handle section. The load transmission tubes are configured to transmit the articulation reaction forces of the flex section back to the handle section, thereby reducing articulation forces that would otherwise be applied to the proximal shaft and the anti-slip passive section. Such a design may beneficially prevent these articulation forces from being resolved through the proximal shaft and the anti-slip passive section, thus providing a stable elongated member. The transmission modalities described herein may ensure that the proximal shaft and the anti-slip passive section experience minimal axial compression or extension forces, thereby remaining stable during articulation of the flex section.

[0054]

[0070] In a preferred embodiment of the coilpipe mechanism, the coilpipes may be longer than the length of the proximal shaft and the anti-slip passive section. The length of the coilpipe may be determined such that when the coilpipe is under axial compression, it remains longer than the length of the proximal shaft and the anti-slip passive section, thereby preventing loads from being transmitted through the proximal shaft and the anti-slip passive section. For example, the length of the load transmission tube may be at least 0.01%, 0.1%, 0.2%, 0.3%, 1%, 5%, 10% longer than the full length of the proximal shaft and the anti-slip passive section.

[0055]

[0071] The distal end of the coil pipe may be fixed at the interface 315 between the anti-slip passive section and the active bending section. For example, the distal end of the coil pipe may be mechanically restrained in a counterbore feature or soldered, welded, or glued to a coil pipe ring structure 311. The coil pipe ring may beneficially prevent movement of the distal end of the coil pipe. The proximal end of the coil pipe may be fixed to a coil pipe plate 313 located in the handle (or proximal portion of the endoscope), thereby preventing movement of the proximal end of the coil pipe. The coil pipe may be compressed between two fixation points and may have a longer path from the proximal end to the distal end of the scope compared to the path through the neutral axis of the scope. Fixation at both ends of the coil pipe, combined with the extra length of the coil pipe, allows the pull wire to travel a constant distance between the two fixation points regardless of the shape of the scope through tortuous anatomy, which prevents unintended movement of the shaft during articulation of the bending section.

[0056]

[0072] The coil pipe may have any configuration between the two fixed points as long as the configuration can accommodate displacement within the shaft tube. For example, when the passive section or proximal shaft is bent, such as to follow a tortuous anatomy, the shaft tube or passive section may cause displacement of the shaft tube bore and components housed within the passive section. In this case, the extra length of the coil pipe may beneficially accommodate displacement within the shaft tube bore or passive section while improving the stability of the elongated member.

[0057]

[0073] In some embodiments, the elongate member may comprise a sleeve or jacket. FIG. 3B shows an example of a jacket 321 applied over a catheter. The jacket 321 may cover the active bending section, the anti-detachment passive section, and the proximal shaft of the scope. The jacket may be formed of a polymer or any suitable material, such as PTFE, Pebax, polyurethane, or nylon. In some cases, the jacket may be manufactured by polymer extrusion. The jacket may have multiple layers, including braids, to provide torsional stiffness to the elongate member. In some embodiments, the jacket may have a variable stiffness profile along its length. For example, the jacket may have two, three, four, or more different stiffnesses, or multiple segments 323, 325, 327, 329 of different stiffness along the length of the catheter, by laminating together extrudates of different durometers. In some cases, the stiffness of the segments closer to the distal end of the catheter (e.g., segment 323) may be less than the stiffness of the segments closer to the proximal end (e.g., segment 239). The different segments 323, 325, 327, 329 may or may not correspond to an active bending section, a passive section, and a proximal shaft.

[0058]

[0074] FIG. 3C shows another example of a jacket 330 that includes multiple segments and / or layers with different stiffnesses. In some embodiments, the dimensions, materials, and / or characteristics forming the various segments of the jacket may be selected to provide a smooth outer layer and / or variable stiffness. This may beneficially provide sufficient support or stiffness at the proximal portion of the endoscope while maintaining flexibility at the distal portion of the endoscope. In the illustrated exploded view of the exemplary jacket, the jacket may include an inner layer 331 having an intermediate level of stiffness. The inner layer 331 may be formed of a Pebax liner that extends throughout the endoscope shaft. The jacket 330 may include a second layer 333 that is on the outside of the inner layer. In the illustrated example, the second layer may be formed of a stainless steel braid. In some cases, the stainless steel braid may be selected with an optimal pitch and pattern to provide the desired stiffness. The stainless steel braid may have an optimal range of pitches per inch (PPI) to provide the desired stiffness. For example, a 70 PPI (pitch per inch) + / - 30 PPI (full pattern) stainless steel braid may be utilized. The jacket 330 may further include a third component 332 formed of polyethylene terephthalate (PET) to encapsulate the stainless steel braid 333 at the distal end. The third component 332 may be external to the stainless steel braid 333 and may be located substantially at the distal end. The jacket 300 may include an outer layer. The outer layer may include a plurality of segments 334, 335, 336. In some cases, the outer layer of the jacket may include a distal segment 334 formed of soft stiffness Pebax, a middle segment 335 formed of medium stiffness Pebax, and a proximal segment 336 formed of high stiffness Pebax. The Pebax material forming the outer layer of the jacket may contain a low friction additive, such as ProPell, Mobilize, or the like, to reduce friction on the outer surface of the jacket. It should be noted that the materials and dimensions of the various segments are for illustrative purposes only and one of ordinary skill in the art will understand that this is not intended to be limiting.

[0059] Flexible Endoscope

[0075] In some embodiments, the slippage prevention mechanism herein may be utilized to improve the reliability and stability of a flexible endoscope. The slippage prevention mechanism provided may be utilized by any device or apparatus. In one aspect of the present invention, a flexible endoscope with improved performance (e.g., improved reliability) and reduced cost is provided. FIG. 10 illustrates an example of a flexible endoscope 1000 according to some embodiments of the present disclosure. As shown in FIG. 10, the flexible endoscope 1000 may include a handle / proximal portion 1009 and a flexible elongate member that is inserted into a subject. The flexible elongate member may be the same as described above. In some embodiments, the flexible elongate member may include a proximal shaft (e.g., insertion shaft 1001), a steerable tip (e.g., tip 1005), a steerable section (active bending section 1003), and a slippage prevention passive section 1004. The active bending section, slippage prevention passive section, and proximal shaft section may be the same as described elsewhere herein. Endoscope 100 may also be referred to as a steerable catheter assembly, as described elsewhere herein. In some cases, endoscope 100 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 the instrument drive mechanism and can be discarded. In some embodiments, the endoscope may contain varying levels of stiffness along the shaft to improve functional operation.

[0060]

[0076] The endoscope or steerable catheter assembly 1000 may include a handle portion 1009 that may include one or more components configured to process image data, provide power, or establish communication with other external devices. For example, the handle portion may include circuitry and communication elements that enable electrical communication between the steerable catheter assembly 1000 and an instrument drive mechanism (not shown) and any other external systems or devices. In another example, the handle portion 1009 may include circuit elements such as a power supply for powering the endoscope's electronics (e.g., camera, electromagnetic sensors, and LED lights).

[0061]

[0077] One or more components located in the handle may be optimized so that expensive and complex components may be allocated to a robotic assistance system, a handheld controller, or an instrument drive mechanism, thereby reducing costs and simplifying the design of the single-use endoscope. The handle or proximal portion may provide electrical and mechanical interfaces to allow electrical and mechanical communication with the instrument drive mechanism. The instrument drive mechanism may include 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 on the instrument drive mechanism, whereby its pulley / capstan assembly is driven by a set of motors. The number of pulleys may vary based on the pull wire configuration. In some cases, one, two, three, four, or more pull wires may be utilized to articulate the flexible endoscope or catheter.

[0062]

[0078] The handle portion may be designed to allow the robotic bronchoscope to be disposable at reduced cost. For example, conventional manual bronchoscopes and robotic bronchoscopes may have cables at the proximal end of the bronchoscope handle. The cables often include illumination fibers, camera video cables, and other sensor fibers or cables, such as electromagnetic (EM) sensors or shape-sensing fibers. Such complex cables may be expensive, adding to the cost of the bronchoscope. The provided robotic bronchoscope may have an optimized design such that simplified structures and components can be employed while maintaining mechanical and electrical functionality. In some cases, the handle portion of the robotic bronchoscope may employ a cable-less design while providing a mechanical / electrical interface to the catheter.

[0063]

[0079] The electrical interface (e.g., a printed circuit board) may enable image / video data and / or sensor data to be received by the communication module of the instrument drive mechanism and transmitted to other external devices / systems. In some cases, the electrical interface may establish electrical communication without cables or wires. For example, the interface may comprise pins soldered onto an electronic board such as a printed circuit board (PCB). For example, a receptacle connector (e.g., a female connector) is provided on the instrument drive mechanism as a mating interface. This may advantageously allow an endoscope to be quickly plugged into the instrument drive mechanism or robot support without utilizing extra cables. Such a type of electrical interface may also serve as a mechanical interface, such that when the handle portion is plugged into the instrument drive mechanism, both a mechanical and electrical coupling are established. Alternatively or additionally, the instrument drive mechanism may provide only a mechanical interface. The handle portion may be in electrical communication with the modular wireless communication device or any other user device (e.g., a portable / handheld device or controller) to transmit sensor data and / or receive control signals.

[0064]

[0080] In some cases, the handle portion 1009 may include one or more mechanical control modules, such as a luer 1011 for interfacing with an irrigation / aspiration system. In some cases, the handle portion may include a lever / knob for articulation control. Alternatively, the articulation control may be located in a separate controller attached to the handle portion via the instrument drive mechanism.

[0065]

[0081] The endoscope may be attached to a robotic assisted system or a handheld controller via an instrument drive mechanism. The instrument drive mechanism may be provided by any suitable controller device (e.g., a handheld controller), which may or may not include a robotic system. The instrument drive mechanism may provide a mechanical and electrical interface to the steerable catheter assembly 1000. The mechanical interface may allow the steerable catheter assembly 1000 to be releasably coupled to the instrument drive mechanism. For example, a handle portion of the steerable catheter assembly may be attached to the instrument drive mechanism via a quick installation / release means, such as a magnet, a spring-loaded level, or the like. In some cases, the steerable catheter assembly may be coupled to or released from the instrument drive mechanism manually without the use of tools. More details about the instrument drive mechanism are provided later in this specification.

[0066]

[0082] In the illustrated example, the distal tip of the catheter or endoscope shaft is configured to articulate / bend with two or more degrees of freedom to provide a desired camera view or control the direction of the endoscope. As illustrated in this example, an imaging device (e.g., a camera), a position sensor (e.g., an electromagnetic sensor) 1007 is located at the tip 1005 of the catheter or endoscope shaft. For example, the line of sight of the camera can be controlled by controlling the articulation of the active bending section 1003. In some examples, the angle of the camera may be adjustable, whereby 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 can be oriented at an angle (e.g., tilt) relative to the axial direction of the tip of the endoscope with the help of suitable components.

[0067]

[0083] The distal tip 1005 may be a rigid component that allows for positioning of sensors, such as electromagnetic (EM) sensors, imaging devices (e.g., cameras), and other electronic components (e.g., LED light sources) embedded in the distal tip.

[0068]

[0084] In real-time EM tracking, an EM sensor, consisting of one or more sensor coils embedded in one or more locations and one or more orientations in a medical instrument (e.g., the tip of an endoscopic tool), measures the variations in the EM field created by one or more static EM field generators positioned in locations close to the patient. The location information detected by the EM sensor 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 can detect. The magnetic field induces a small current in the sensor coil of the EM sensor, which can be analyzed to determine the distance and angle between the EM sensor and the EM field generator. For example, the EM field generator may be positioned close to the patient's torso during a procedure to locate the EM sensor in 3D space, or may locate the EM sensor's position and orientation in 5D or 6D space. This may provide a visual guide to the surgeon when driving the bronchoscope toward the target site.

[0069]

[0085] The endoscope may have a unique design for the elongate member. In some cases, the endoscope's active bending section 1003, anti-slip passive section, and proximal shaft may be constructed from a single tube incorporating a series of discontinuities (e.g., reliefs, slits, etc.) along its length to allow for improved flexibility, desirable stiffness, and anti-slip features (e.g., features that define a minimum bend radius).

[0070]

[0086] As mentioned above, the active bending section 1003 may be designed to allow bending (e.g., articulation) in two or more degrees of freedom. Larger degrees of bending, such as 180 degrees and 270 degrees (or other articulation parameters for clinical indications) may be achieved by the unique structure of the active bending section, while kinking or prolapse may be prevented by the passive section following the active bending section. In some cases, the active bending section and / or the passive section may be fabricated separately as modular components and assembled to the proximal shaft. In some cases, the cutting patterns of the active bending section and the passive section may be different, thereby at least the minimum bending radius of the two sections may be different. In some cases, a variable minimum bending radius may be provided along the axial axis of the elongated member, such that the active bending section or the passive section may have two or more different minimum bending radii.

[0071]

[0087] The articulation of the endoscope may be controlled by applying force to the distal end of the endoscope via one or more pull wires. One or more pull wires may be attached to the distal end of the endoscope. In the case of multiple pull wires, pulling one wire at a time may change the orientation of the distal tip to pitch up, pitch down, left, right, or any direction required. In some cases, the pull wires may be fixed to the distal tip of the endoscope and extend through a bending section and enter a handle where they are coupled to a drive component (e.g., a pulley). This handle pulley may interact with an output shaft from the robotic system.

[0072]

[0088] 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.) within the handle portion of the catheter assembly. The pull wires may be metallic wires, cables, or threads, or polymeric wires, cables, or threads. The pull wires may also be made of natural or organic materials or fibers. The pull wires may be any type of suitable wire, cable, or thread capable of supporting various types of loads without deformation, significant deformation, or breakage. The distal end / portion of one or more pull wires may be fixed or integral to the distal portion of the catheter, such that operation of the pull wires by the control unit may apply a force or tension to the distal portion that may steer or articulate at least the distal portion (e.g., flexible section) of the catheter (e.g., up, down, pitch, yaw, or any direction in between).

[0073]

[0089] The pull wires may be made of any suitable material, such as stainless steel (e.g., SS316), metals, alloys, polymers, nylon, or biocompatible materials. The pull wires may be wires, cables, or threads. In some embodiments, different pull wires may be made of different materials to vary the load-bearing capabilities of the pull wires. In some embodiments, different sections of the pull wires may be made of different materials to vary stiffness and / or load-bearing along the pull. In some embodiments, the pull wires may be utilized for transmission of electrical signals.

[0074]

[0090] The proximal design can improve the reliability of the device without introducing extra costs, allowing for a low-cost single-use endoscope. In another aspect of the present invention, a single-use robotic endoscope is provided. The robotic endoscope can be a bronchoscope and can be the same as the steerable catheter assembly described elsewhere herein. Conventional endoscopes can be complex in design and are usually designed to be reused after a procedure, requiring extensive cleaning, disinfection, or sterilization after each procedure. Existing endoscopes are often designed with complex structures to ensure that the endoscope can withstand cleaning, disinfection, and sterilization processes. The provided robotic bronchoscope can be a single-use endoscope that can beneficially reduce cross-contamination and infection between patients. In some cases, the robotic bronchoscope can be delivered to a medical practitioner in a pre-sterilized package and is intended to be discarded after a single use.

[0075]

[0091] As shown in FIG. 11, the robotic bronchoscope 1120 may include a handle portion 1113 and a flexible elongated member 1111. In some embodiments, the flexible elongated member 1111 may include a shaft, a steerable tip, a steerable / active bending section, and an anti-slip passive section. The robotic bronchoscope 1120 may be the same as the steerable catheter assembly described in FIG. 10. The robotic bronchoscope 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 bronchoscope may be released from the instrument drive mechanism and can be discarded. In some cases, the bronchoscope may contain varying levels of stiffness along its shaft to improve functional operation. In some cases, the minimum bend radius along the shaft may vary, whereby kink resistance or anti-slip capabilities may be configurable along the length.

[0076]

[0092] The robotic bronchoscope can be releasably coupled to an instrument drive mechanism 1120. The instrument drive mechanism 1120 can be mounted to an arm of a robotic assistance system or to any actuation assistance system as described elsewhere herein. The instrument drive mechanism can provide a mechanical and electrical interface to the robotic bronchoscope 1110. The mechanical interface can allow the robotic bronchoscope 1110 to be releasably coupled to the instrument drive mechanism. For example, a handle portion of the robotic bronchoscope can be attached to the instrument drive mechanism via a quick mounting / release means such as a magnet and a spring-loaded level. In some cases, the robotic bronchoscope can be manually coupled to or released from the instrument drive mechanism without the use of tools.

[0077]

[0093] FIG. 12 shows an example of an instrument drive mechanism 1220 that provides a mechanical interface to a handle portion 1213 of a robotic bronchoscope. As shown in the example, the instrument drive mechanism 1220 may include a set of motors that are actuated to rotationally drive a set of pull wires of a flexible endoscope or catheter. The handle portion 1213 of the catheter assembly may be mounted on the instrument drive mechanism, whereby its pulley assembly or capstan is driven by the set of motors. The number of pulleys may vary based on the pull wire configuration. In some cases, one, two, three, four, or more pull wires may be utilized to articulate the flexible endoscope or catheter.

[0078]

[0094] The handle portion may be designed to allow the robotic bronchoscope to be disposable at reduced cost. For example, conventional manual bronchoscopes and robotic bronchoscopes may have cables at the proximal end of the bronchoscope handle. The cables often include illumination fibers, camera video cables, and other sensor fibers or cables, such as electromagnetic (EM) sensors or shape-sensing fibers. Such complex cables may be expensive, adding to the cost of the bronchoscope. The provided robotic bronchoscope may have an optimized design such that simplified structures and components can be employed while maintaining mechanical and electrical functionality. In some cases, the handle portion of the robotic bronchoscope may employ a cable-less design while providing a mechanical / electrical interface to the catheter.

[0079]

[0095] FIG. 13 shows an example of a distal tip 1300 of an endoscope. In some cases, the distal portion or tip 1300 of the catheter may be substantially flexible so that it can be steered in one or more directions (e.g., pitch, yaw). The catheter may comprise a tip section, a bending section, and an insertion shaft. In some embodiments, the catheter may have a variable bending stiffness along the longitudinal axis. For example, the catheter may comprise multiple sections with different bending stiffness (e.g., flexible, semi-rigid, and rigid). The bending stiffness may be varied by selecting materials with different stiffness / inflexibility, varying the structure (e.g., cuts, patterns) of different segments, adding additional support components, or any combination of the above. In some embodiments, the catheter may have a variable minimum bend radius along the longitudinal axis. Selecting different minimum bend radii at different locations along the catheter may beneficially provide anti-misalignment capabilities while still allowing the catheter to reach hard-to-reach areas. In some cases, the proximal end of the catheter does not need to be highly bent, and thus the proximal portion of the catheter may be reinforced with additional mechanical structures (e.g., additional layers of material) to achieve greater bending stiffness. Such a design may provide support and stability to the catheter. In some cases, variable bending stiffness may be achieved by using different materials during the extrusion of the catheter. This may advantageously allow for different stiffness levels along the shaft of the catheter in the extrusion manufacturing process without the need for additional fasteners or the assembly of different materials.

[0080]

[0096] The distal portion of the catheter may be steered by one or more pull wires 1305. The distal portion of the catheter may be made of any suitable material, such as a copolymer, polymer, metal, or alloy, so that it can be bent by the pull wires. In some embodiments, the proximal or terminal ends of the one or more pull wires 1305 may be coupled to a drive mechanism (e.g., gears, pulleys, capstans, etc.) via a fixation mechanism as described above.

[0081]

[0097] The pull wires 1305 may be metallic wires, cables, or threads, or may be polymeric wires, cables, or threads. The pull wires 1305 may also be made of natural or organic materials or fibers. The pull wires 1305 may be any type of suitable wire, cable, or thread capable of supporting various types of loads without deformation, significant deformation, or breakage. The distal ends or distal portions of one or more pull wires 1305 may be fixed or integral to the distal portion of the catheter, such that operation of the pull wires by the control unit may apply a force or tension to the distal portion that may steer or articulate at least the distal portion (e.g., flexible section) of the catheter (e.g., up, down, pitch, yaw, or any direction in between).

[0082]

[0098] The catheter may have dimensions such that one or more electronic components may be integrated into the catheter. For example, the outer diameter of the distal tip may be about 4-4.4 millimeters (mm) and the diameter of the working channel 1303 may be about 2 mm such that one or more electronic components may be embedded in the wall of the catheter. It should be noted, however, that based on different applications, the outer diameter may be in any range less than 4 mm or greater than 4.4 mm, and the diameter of the working channel may be in any range according to the dimensions of the tool or the particular application.

[0083]

[0099] The one or more electronic components may comprise an imaging device, an illumination device, or a sensor. In some embodiments, the imaging device may be a video camera 1313. The imaging device may comprise an optical element and an image sensor for capturing image data. The image sensor may be configured to generate image data in response to wavelengths of light. Various image sensors, such as complementary metal oxide semiconductor (CMOS) or charge-coupled device (CCD), may be employed for capturing image data. 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 multiple electronic elements for processing the image signal. For example, the circuit for the CCD sensor may comprise an A / D converter and an amplifier for amplifying and converting an analog signal provided by the CCD sensor. Optionally, the image sensor may be integrated with an amplifier and a converter to convert the analog signal to a 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 signal) and may be further processed by the camera circuit or a processor of the camera. In some cases, the image sensor may comprise an array of light sensors.

[0084]

[0100] The illumination device may include one or more light sources 1311 positioned at the distal tip. The light sources may be light emitting diodes (LEDs), organic LEDs (OLEDs), quantum dots, or any other suitable light source. In some cases, the light sources may be miniature LEDs for compact design, or dual-tone flashing LED illumination.

[0085]

[0101] The imaging and lighting devices may be integrated into the catheter. For example, the distal portion of the catheter may include appropriate structure to match at least the dimensions of the imaging and lighting devices. The imaging and lighting devices may be embedded in the catheter. FIG. 14 shows an example of a distal portion of a catheter with integrated imaging and lighting devices. The distal portion may have a camera located therein. The distal tip may have structure to receive the camera, lighting device, and / or location sensor. For example, the camera may be embedded in a cavity 1410 in the distal tip of the catheter. The cavity 1410 may be integrally formed with the distal portion of the cavity and may have dimensions to match the length / width of the camera so that the camera does not move relative to the catheter. The camera may be adjacent to the working channel 1420 of the catheter to provide a near-field view of the tissue or organ. In some cases, the attitude or orientation of the imaging device may be controlled by controlling the rotational motion (e.g., roll) of the catheter.

[0086]

[0102] Power to the camera may be provided by a wired cable. In some cases, the cable wires may be in a wire bundle that provides power to the camera as well as lighting elements or other circuitry at the distal tip of the catheter. The camera and / or light source may be powered from a power source located in the handle portion via wires, copper wires, or any other suitable means that extend over the length of the catheter. In some cases, real-time images or videos of the tissue or organ may be transmitted wirelessly to an external user interface or display. 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 broadcast to multiple devices or systems. In some cases, images and / or videos from the camera may be transmitted along the length of the catheter to a processor located in the handle portion via wires, copper wires, or any other suitable means. Image or video data may be transmitted to an external device / system via a wireless communication component in the handle portion. In some cases, the system may be designed such that the wires are not visible or exposed to the surgeon.

[0087]

[0103] In traditional endoscopy, illumination light may be provided by a fiber optic cable that transmits light from a light source located at the proximal end of the endoscope to the distal end of the robotic endoscope. In some embodiments of the present disclosure, a miniature LED light may be employed and embedded in the distal portion of the catheter to reduce design complexity. In some cases, the distal portion may include a structure 1430 having dimensions that match the dimensions of the miniature LED light source. As shown in the illustrated example, two cavities 1430 may be integrally formed with the catheter to receive the two LED light sources. For example, the outer diameter of the distal tip may be about 4-4.4 millimeters (mm) and the diameter of the working channel of the catheter may be about 2 mm such that two LED light sources may be embedded in the distal end. The outer diameter may be in any range less than 4 mm or greater than 4.4 mm and the diameter of the working channel may be in any range according to the dimensions of the tool or the particular application. Any number of light sources may be included. The internal structure of the distal portion may be designed to accommodate any number of light sources.

[0088]

[0104] In some cases, each of the LEDs may be connected to a power wire that may extend to the proximal handle. In some embodiments, the LEDs may be soldered to separate power wires that are later bundled together to form a single strand. In some embodiments, the LEDs may be soldered to a pull wire that provides power. In other embodiments, the LEDs may be crimped or directly connected to a single pair of power wires. In some cases, a protective layer, such as a thin layer of biocompatible adhesive, may be applied to the front of the LEDs to provide protection while still allowing light to be emitted. In some cases, an additional cover 1431 may be placed on the advancing end face of the distal tip to provide accurate positioning of the LEDs as well as sufficient space for the adhesive. The cover 1431 may be made of a transparent material that matches the index of refraction of the adhesive so that the illumination light is not blocked.

[0089]

[0105] The working channels (e.g., working channels 1303, 1420) may be designed to provide protection for internal components such as flexible instruments (e.g., needles, forceps, etc.). When passing through conventional working channels, flexible instruments may be impeded by the working channel due to kinking, ovalization, and / or high friction forces. The working channels herein may advantageously address the above shortcomings by providing high hoop strength and the ability to achieve low bend radii. The working channels may also be designed to provide low friction on the inner surface.

[0090]

[0106] The working channels herein may comprise varying stiffness along their length to provide flexibility to achieve small bend radii while having high hoop strength (e.g., high ability to withstand forces exerted over an area in the circumferential direction (perpendicular to the axis and radius) toward both cylinder walls), thereby providing sufficient protection for the internal components. In some embodiments, the working channel may comprise multiple segments. FIG. 15 shows an example of a working channel 1500. In some embodiments, the working channel may comprise multiple layers and / or multiple segments. As shown in the exploded view, the working channel 1500 may comprise an inner layer 1501 throughout the length of the working channel. The inner layer 1501 may be formed of a polymer, such as a PTFE material. The inner layer or PTFE liner 1501 may provide a low friction inner surface for the internal components. The working channel may comprise a second layer 1502 that is on the outside of the PTFE liner. In some embodiments, the second layer 1502 may be formed of a stainless steel braid with an optimal pitch to provide the desired stiffness. For example, a 150 PPI (pitch per inch) + / - 30 PPI (full pattern) stainless steel braid may be used to provide high hoop strength throughout the working channel 1500. This beneficially strengthens the working channel and prevents it from kinking. The working channel may include an outer layer 1503. The outer layer may be formed of medium and high stiffness Pebax to cover the entire working channel. In some cases, additional layers may be included to reinforce selected segments. For example, a medium stiffness Pebax segment 1504 may be used to provide additional hoop strength to selected segments of the working channel, thereby reinforcing the segments. This may beneficially allow for small bend radii of 5 mm or less, 6 mm or less, 7 mm or less, 8 mm or less, 9 mm or less, 10 mm or less, 15 mm or less, 20 mm or less, or 30 mm or less.

[0091] [000107] While preferred embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will occur to those skilled in the art without departing from the invention. It is to be understood that various alternatives to the embodiments of the present invention described herein may be employed in the practice of the present invention. It is intended that the following claims define the scope of the invention, and that methods and structures within the scope of the claims and their equivalents are covered thereby.

Claims

1. an elongate member extending between a distal end and a proximal end; The elongated member includes: an active bending section steerable by one or more pull wires; a passive section located between the active bending section and the proximal shaft section, the passive section includes an anti-slip structure that determines a minimum bend radius of the passive section, thereby preventing slippage; Articulating flexible endoscope.

2. the distal end is connected to a distal tip portion of the articulating flexible endoscope; The articulating, flexible endoscope of claim 1 , wherein the distal tip portion comprises structure for receiving an imaging device, a position sensor, and an illumination device.

3. the proximal end is connected to a proximal portion of the articulating flexible endoscope; The articulating flexible endoscope of claim 1 , wherein the proximal portion comprises a drive mechanism for applying force to the one or more puller wires.

4. The articulating flexible endoscope of claim 1 , wherein the anti-dislodgement structure is integrally formed within the passive section.

5. the anti-dislodgement structure comprises a cut pattern; The articulating flexible endoscope of claim 4 , wherein the minimum bend radius is determined at least in part based on a gap size of the cutting pattern.

6. The articulating flexible endoscope of claim 5 , wherein the cutting pattern comprises gaps and interlocking features.

7. The articulating flexible endoscope of claim 1 , wherein the passive section has two or more different minimum bend radii.

8. the anti-dislodgement structure comprises a cut pattern; 8. The articulating flexible endoscope of claim 7, wherein the two or more different minimum bend radii are determined by selecting different gap sizes and / or selecting different pitches of the cut pattern.

9. The articulating flexible endoscope of claim 1 , wherein the minimum bend radius of the active bending section is less than the minimum bend radius of the passive section.

10. The articulating flexible endoscope of claim 9 , wherein the active bending section has two or more different minimum bend radii.

11. The articulating flexible endoscope of claim 1 , further comprising one or more coil pipes having a distal end fixed to an interface between the passive section and the active bending section.

12. The articulating flexible endoscope of claim 11 , wherein a proximal end of the one or more coil pipes is secured to a handle of the articulating flexible endoscope.

13. The articulating flexible endoscope of claim 1 further comprising a jacket as an outer layer of said elongated member.

14. 4. The articulating flexible endoscope of claim 3, wherein the jacket comprises multiple layers and has variable stiffness along the length of the jacket.

15. The articulating flexible endoscope of claim 1 , wherein the proximal shaft section has a stiffness greater than a stiffness of the passive section.

16. 1. A method for preventing slippage or kinking of an articulating flexible endoscope, comprising: Providing an elongated member; steering an active bending section of the elongate member via one or more pull wires to navigate the articulating flexible endoscope through a passageway; providing a passive section located between the active bending section and a proximal shaft section; The method of claim 1, wherein the passive section comprises an anti-slip structure that determines a minimum bend radius of the passive section, thereby preventing slippage of the articulating flexible endoscope while it is passing through the passageway.

17. The method of claim 16 , wherein the anti-excursion structure is integrally formed within the passive section.

18. The method of claim 16 , wherein the anti-retraction structure comprises a cut pattern including repeated gap features and interlocking features.

19. The method of claim 18 , wherein the minimum bend radius is determined based at least in part on a gap size of the gap feature.

20. The method of claim 16 , wherein the passive sections have two or more different minimum bend radii.

21. the anti-dislodgement structure comprises a cut pattern; 21. The method of claim 20, wherein the two or more different minimum bend radii are determined by selecting different gap sizes and / or selecting different pitches of the cutting patterns.

22. The method of claim 16 , wherein the active bending section has a minimum bend radius that is smaller than the minimum bend radius of the passive section.

23. The method of claim 16 , wherein the active bending section has two or more different minimum bend radii.

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