Systems and methods for medical device intubation

Abstract

An outer casing apparatus is provided. The outer cannula apparatus includes features to form a first lumen for passage of a first mirror during intubation. The first lumen is deformable to create a second lumen for passage of the second mirror. The diameter of the second mirror is larger than that of the first mirror.

Description

[0001] Cross-reference

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 375,436, filed on September 13, 2022, which is hereby incorporated by reference in its entirety. BACKGROUND OF THE INVENTION

[0003] Endoscopic procedures use an endoscope to examine the interior of a hollow organ or body cavity. Unlike many other medical imaging techniques, the endoscope is inserted directly into the organ. A flexible endoscope that relies on intuitive manipulation and control can be delivered for diagnosing and treating diseases that are accessible through any natural orifice in the body. Depending on the clinical indication, the endoscope can be designated as a bronchoscope, ureteroscope, colonoscope, gastroscope, ENT scope (ear, nose, and throat scope), and various other endoscopes. For example, a flexible colonoscope can be inserted into the transverse colon for diagnosis and / or surgical treatment.

[0004] Certain endoscopes, such as colonoscopes or gastroscopes, may have a relatively large size and / or stiffness (compared to other types of endoscopes), which makes navigating tortuous anatomy more challenging. For example, a clinician may use an outer sheath to facilitate intubation, thereby providing a low-friction surface and a defined path to guide the insertion of the colonoscope. In some cases, a reduction method can be employed to facilitate intubation by shortening the length of the colon and reducing its tortuosity by anchoring to the colon at the distal end and applying tension. However, intubation using an outer sheath can also be challenging. One such difficulty in the current colon intubation process is the relatively large size of the outer sheath device (i.e., the balloon outer sheath) used to create a passage for the internal endoscope and assist in intubation. SUMMARY OF THE INVENTION

[0005] There is a need to improve the intubation process of an intraluminal endoscope device. The present disclosure addresses this need by providing an improved outer sheath for intubation of an intraluminal device. In particular, the outer sheath device of the present disclosure can facilitate the intubation process without reducing the size or dimensions (compared to conventional intubation processes or devices).

[0006] In one aspect, a device for intubating an endoscope into a subject is provided. The device includes a flexible outer sheath that includes features to form a first lumen for passing a first scope during intubation. The first lumen is deformable to create a second lumen for passing a second scope, and the diameter of the second scope is greater than the diameter of the first scope.

[0007] In some embodiments, the diameter of the first lumen is smaller than the diameter of the second lumen. In some embodiments, the feature includes an expandable tubular structure to adjust the size of the first lumen or the second lumen. In some cases, the expandable tubular structure is a flat tube configuration that is pleated along an axial direction. In some cases, the expandable tubular structure is a collapsible flat tube configuration. In some cases, the collapsible flat tube configuration has separable edges that are joined by one or more active engagement features. In some cases, the collapsible flat tube configuration adjusts the diameter of the first lumen by means of one or more passive engagement features to create the second lumen.

[0008] In some embodiments, the first lumen and the second lumen are two channels separated by a lumen separator of a flexible outer sheath. In some embodiments, the second mirror is a robotic mirror. In some cases, the robotic mirror includes a handle portion releasably coupled to a robotic support. In some cases, the handle portion of the robotic mirror is coupled to the robotic support after the robotic mirror is inserted into the second lumen in a zigzag shape. In some cases, the robotic mirror is initialized by eliminating slack in one or more pull wires that control the articulation of the curved section while the curved section of the robotic mirror conforms to the internal environment within the subject.

[0009] In another aspect, a method for inserting a robotic endoscope into a subject is provided. The method includes: (a) performing an initial intubation using a first mirror and an outer sheath device to reach a target site within the body of the subject, wherein the first mirror is engaged with the first lumen of the outer sheath device; (b) withdrawing the first mirror and inserting a second mirror into the second lumen of the outer sheath device to reach the target site, wherein the second mirror is a robotic mirror having a diameter greater than the diameter of the first mirror; (c) coupling the handle portion of the second mirror to an instrument drive mechanism (IDM) and initializing the second mirror while the second mirror is within the body of the subject.

[0010] In some embodiments, initializing includes eliminating slack in one or more pull wires of the second mirror. In some cases, one or more pull wires are driven by the IDM to control the articulation of the curved section of the second mirror in one or more degrees of freedom.

[0011] In some embodiments, the method further includes monitoring the tension in one or more pull wires corresponding to one degree of freedom. In some cases, the method further includes comparing the difference in tension in one or more pull wires to a predetermined threshold. In some examples, the method further includes controlling one or more actuators of the IDM based on the tension or the difference in tension.

[0012] In some embodiments, the first lumen is deformable to create a second lumen. In some embodiments, the outer sheath device includes an expandable tubular structure to adjust the size of the first lumen or the second lumen. In some cases, the expandable tubular structure is a flat tube configuration that is pleated along an axial direction. In some cases, the expandable tubular structure is a collapsible flat tube configuration. In some cases, the first lumen and the second lumen are two channels separated by a lumen separator of the outer sheath device.

[0013] In yet another aspect, a method for initializing a robotic endoscope inside an object is provided. The method includes: (a) driving a pair of wire ropes at a constant speed by an instrument drive mechanism while placing the robotic endoscope inside the object, wherein the pair of wire ropes are actuated to control the articulation corresponding to a first degree of freedom of a bending section of the robotic endoscope; (b) comparing a difference in tension in the pair of wire ropes with a first threshold, and changing the movement of the pair of wire ropes to reduce the difference in tension when the first threshold is reached; and (c) comparing the tension in the pair of wire ropes with a second threshold, and stopping the movement of the corresponding wire rope when the tension in any one of the pair of wire ropes reaches the second threshold.

[0014] In some embodiments, the second threshold is higher than the first threshold. In some embodiments, steps (a)-(c) are repeated for a pair of wire ropes corresponding to a second degree of freedom. In some cases, steps (a)-(c) are performed simultaneously for the first degree of freedom and the second degree of freedom. Alternatively, steps (a)-(c) are performed sequentially for the first degree of freedom and the second degree of freedom.

[0015] In some embodiments, the robotic scope includes a handle portion releasably coupled to the instrument drive mechanism. In some cases, the instrument drive mechanism is supported by an end effector of a robotic arm. In some embodiments, the robotic scope includes a flexible elongate member, and the current shape, position, or orientation of the elongate member is unknown.

[0016] Additional aspects and advantages of the present disclosure will become apparent to those of ordinary skill in the art upon reading the following detailed description, which illustrates and describes only illustrative embodiments of the present disclosure. As will be appreciated, the present disclosure is capable of other and different embodiments, and its several details can be modified in various obvious respects, all without departing from the present disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature and not restrictive.

[0017] Incorporated by reference

[0018] 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. In the event of a conflict between the incorporated publications and patents or patent applications and the disclosure contained herein, the specification is intended to supersede and / or take precedence over any such conflicting material. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the 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 to the accompanying drawings (also referred to herein as "FIGURES"), in which:

[0020] Figure 1 An example of an intubation process is schematically shown.

[0021] Figure 2 An example of an expandable outer sheath is shown, which is shaped to surround an endoscope.

[0022] Figures 3A - 3C An example of an outer sheath with a temporary longitudinal seam is shown, which constitutes an expandable outer sheath device.

[0023] Figure 4 An example of an outer sheath is shown, which achieves volume reduction via internal vacuum during initial intubation.

[0024] Figure 5 An example of an outer sheath device is shown, which includes a collapsible outer sheath.

[0025] Figures 6A - 6B An example of an outer sheath device with a flexible multi-lumen configuration is shown.

[0026] Figure 7 An example of a flexible endoscope according to some embodiments of the present disclosure is illustrated.

[0027] Figure 8 A robotic endoscope including a handle portion and a flexible elongate member is shown.

[0028] Figure 9 An example of an instrument drive mechanism providing a mechanical interface to the handle portion of the robotic endoscope is shown.

[0029] Figure 10 An example of the distal tip of an endoscope is shown.

[0030] Figure 11 An example of a distal portion of a catheter having an integrated imaging device and a lighting device is shown.

[0031] Figure 12 An example of an algorithm for initializing a robotic endoscope (e.g., a robotic colonoscope) to an instrument drive mechanism (IDM) is shown.

[0032] Figure 13 and Figure 14 An example of an instrument drive mechanism (IDM) that provides a mechanical interface to the handle portion of a robotic endoscope is shown.

[0033] Figure 15 An example of a robotic colonoscope is shown.

[0034] Figure 16 An example of the tip for a robotic colposcope device is shown. DETAILED DESCRIPTION

[0035] Although 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. Many variations, changes, and substitutions will be apparent to those skilled in the art without departing from the present invention. It should be understood that various alternatives to the embodiments of the present invention described herein may be employed.

[0036] The embodiments disclosed herein may be combined in one or more of many ways to provide improved diagnosis and treatment for patients. The disclosed embodiments may be combined with existing methods and devices to provide improved treatment, such as in combination with known pulmonary diagnostic, surgical methods, and surgical methods for other tissues and organs. It should be understood that any one or more of the structures and steps described herein may be combined with any one or more additional structures and steps of the methods and devices described herein, and the drawings and supporting text provide a description according to the embodiments.

[0037] While the exemplary embodiments will be directed primarily to devices or systems for colonoscopes or gastroscopes, those skilled in the art will understand that this is not intended to be limiting, and the devices described herein can be used in other therapeutic or diagnostic procedures and in various anatomical regions of the patient's body. The provided device or system can be used in urology, gynecology, rhinology, otology, laryngoscopy, gastroenterology using an endoscope, a combined device including an endoscope and instruments, an endoscope with positioning function. Those skilled in the art will understand that this is not intended to be limiting, and the devices described herein can be used in other therapeutic or diagnostic procedures and in other anatomical regions of the patient's body, such other anatomical regions being, for example, the brain, heart, lungs, intestines, eyes, skin, kidneys, liver, pancreas, stomach, uterus, ovaries, testicles, bladder, ears, nose, mouth, soft tissues (such as bone marrow, adipose tissue, muscle, glandular and mucosal tissues, spinal cord and nerve tissues, cartilage), hard biological tissues (such as teeth, bones, etc.), and body cavities and passages (such as sinuses, ureters, colon, esophagus, lung passages, blood vessels and throat), as well as various other sites. The devices described herein are in the form of: neuroendoscopes, brain scopes, ophthalmoscopes, otoscopes, rhinoscopes, laryngoscopes, gastroscopes, esophagoscopes, bronchoscopes, thoracoscopes, pleuroscopes, angioscopes, mediastinoscopes, nephroscopes, gastroscopes, duodenoscopes, choledochoscopes, cholangioscopes, laparoscopes, amnioscopes, ureteroscopes, hysteroscopes, cystoscopes, proctoscopes, colonoscopes, arthroscopes, salivary gland endoscopes, orthopedic endoscopes, etc., in combination with various tools or instruments.

[0038] The systems and devices herein can be combined in one or more of many ways to provide improved diagnosis and treatment for patients. The systems and devices provided herein can be combined with existing methods and devices to provide improved treatment, such as in combination with known pulmonary diagnostic and surgical methods and surgical methods for other tissues and organs. It should be understood that any one or more of the structures and steps described herein can be combined with any one or more additional structures and steps of the methods and devices described herein, and the drawings and supporting text provide a description according to the embodiments.

[0039] Whenever the term "at least", "greater than", or "greater than or equal to" precedes the first 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 value in the series. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.

[0040] Whenever the terms "not more than", "less than", or "less than or equal to" precede the first value in a series of two or more numerical values, the terms "not more than", "less than", or "less than or equal to" apply to each value in the series. For example, less than or equal to 3, 2, or 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.

[0041] As used herein, the terms "distal" and "proximal" generally may refer to positions referenced from the device and may be opposite to anatomic structure references. For example, a distal position of a main shaft or a main conduit may correspond to a proximal position of an elongate member of a patient, and a proximal position of a main sheath or a main conduit may correspond to a distal position of an elongate member of a patient.

[0042] Sheath cannula for a robotic endoscope system

[0043] For diagnostic and therapeutic procedures within a body cavity, traditionally, clinicians use a manual endoscope for intubation. In the case of the colon, for most patients, manual colonoscopy can relatively easily (e.g., within less than 10 minutes) reach a target, such as the cecum (the end of the large intestine). However, for a robotic colonoscopy system, due to the increased size / dimension of the robotic colonoscopy device, the intubation process may be more challenging. During the process of using a robotic colonoscope for assisted or autonomous intubation, an outer sheath can be used to facilitate intubation. The outer sheath is a sleeve-shaped device typically made of semi-rigid plastic or silicone rubber and is designed to assist in endoscopy. To provide a path through the gastrointestinal (GI) tract, an outer sheath with a diameter larger than that of the endoscope is required.

[0044] The current intubation workflow of a robotic colonoscope may have problems such as increased cost, extended intubation time, and a potential risk of perforation when controlling without providing tactile feedback to the user. A typical workflow of a robotic colonoscope may include: docking the colonoscope with the robotic system before intubation. For example, the current intubation workflow of a robotic colonoscope may include: engaging the outer sheath with the colonoscope, coupling the engaged colonoscope and outer sheath to a robotic drive mechanism, and then repeating the process of inflating the balloon, reducing the colon (e.g., shortening and straightening the colon), anchoring the colonoscope with the tip, deflating the balloon, and advancing the outer sheath to the tip of the colonoscope, (under the control of the robotic system) intubating the engaged colonoscope and outer sheath together into the object lumen, and repeating this process until the device reaches the target site. However, the above workflow is time-consuming and may have a potential risk of perforation without providing tactile feedback to the user.

[0045] The present disclosure addresses the above drawbacks by providing an improved workflow for intubating a robotic colonoscope. In particular, the workflow may include: after the colonoscope has been intubated and the colonoscope is in a position and orientation determined by the curvature of the patient's anatomy, coupling the robotic colonoscope to a robotic drive mechanism (instrument drive mechanism (IDM)). Coupling the colonoscope to the robotic drive mechanism is challenging because it is difficult to know the initial colonoscope configuration and the initial colonoscope position once the colonoscope is inside the patient, especially when in a position and orientation determined by the curvature of the patient's anatomy. To control the endoscope (e.g., colonoscope), initialization for coupling the endoscope to the robotic drive mechanism is required because the robotic system needs to know the initial colonoscope configuration and minimize the gap between the drive mechanism and the tip. Failure of the initialization may result in unexpected movement and trauma to the patient.

[0046] However, traditional initialization methods may not be applicable to intubated endoscopes. For robotic instruments, there are generally two initialization methods: one method is to place the device in a fixture that holds the tool in a known position during gap elimination. The second method is to move towards the limits of different degrees of movement and then move away from these limits by a predetermined amount for initialization / calibration. The above methods are not applicable to docking an endoscope device that has been intubated or placed inside a patient because they are either not practical (requiring an additional fixture to place the endoscope in a tensioned fixture) or may potentially harm the patient (the instrument / colonoscope must be moved to its limits).

[0047] The methods and systems herein can provide an improved docking method for an intubated colonoscope, thereby preventing trauma to the patient when coupling a robotic colonoscope to a robotic drive mechanism for robotic intracorporeal surgery.

[0048] In one aspect of the present disclosure, a method for intubating a robotic endoscope device using an outer cannula is provided. The method may provide an improved workflow that includes coupling a robotic colonoscope to a robotic drive mechanism (instrument drive mechanism (IDM)) after the colonoscope has been intubated and the colonoscope is in a position and orientation determined by the curvature of the patient's anatomy. The method may include intubating the robotic endoscope using the outer cannula and then coupling the intubated robotic endoscope to the IDM once the intubated robotic endoscope is inside the subject's body. The outer cannula may have a reduced size, the details of which will be described below.

[0049] Figure 1An example of the intubation process 100 of an endoscopic device is schematically shown. The endoscopic device can be a robotic endoscopic device, such as a robotic colonoscope. The robotic endoscopic device may have an increased size due to additional components for robotic control or robotic features. For example, the diameter of the robotic endoscope may be larger than the standard diameter.

[0050] The intubation workflow 100 can include: intubating 101 with a first scope 120 (e.g., a manual scope, a manual colonoscope), placing an outer sheath 110, and advancing the first scope 120 and the outer sheath 110 together until the position is reached. The first scope 120 can be any available endoscope that can be manually inserted into the patient's lumen. The size of the first scope 120 can be smaller than the size of the second scope (such as a robotic scope) to be intubated. For example, the diameter of the scope 120 can be smaller than the diameter of the robotic scope 130. The intubation step 101 can be a conventional process, such as advancing the curved section of the scope 120 onto the tip of the outer sheath 110, and then advancing the outer sheath to the tip of the scope 120 until they reach the target site 150. The outer sheath 110 can have a reduced size and will be described in detail below.

[0051] Once the tip of the scope reaches the target site or the site of interest 150, the workflow can include operation 102, that is, advancing the outer sheath 110 along the curved section of the scope 120 so as to place the balloon 111 proximal to the tip of the scope 120. Next, the workflow can include operation 103, that is, inflating the balloon 111 and removing the scope 120 while leaving the outer sheath in place. In some cases, the colon can be reduced.

[0052] Next, a second scope 104, such as a robotic endoscope (e.g., a gastroscope or a robotic colonoscope) 130, is inserted through the outer sheath. In some cases, the robotic endoscope 130 can be manually inserted. Once the tip of the robotic endoscope 130 is placed at the site of interest, the proximal end of the robotic endoscope 130 can be connected to a robotic drive mechanism or an instrument drive mechanism (IDM) 140. The workflow can continue with operation 106, that is, deflating the balloon of the outer sheath, and the outer sheath can be pulled in the proximal direction to expose the curved section 131 of the robotic endoscope. In the next operation 107, the balloon 111 of the outer sheath is inflated, and the outer sheath can be grounded, such as via a grounding mechanism 160 located at the proximal end of the outer sheath.

[0053] Then, the robotic endoscope 130 can perform any controlled operation 108 at the site of interest. In some cases, the robotic operation can include the improved initialization process provided by the present disclosure. Once the initialization process is completed, the user or operator can control the robotic colonoscope 130 during the surgery. The colonoscope can be operated in a robotic manner by the user, such as from a doctor's console positioned away from the patient. Once the surgery is completed, the robotic colonoscope is disconnected from the robotic drive mechanism, and the robotic colonoscope together with the outer sheath is removed from the patient. The outer sheath can be single-use or disposable. The robotic colonoscope 130 can be single-use or disposable. Alternatively, at least a portion of the robotic colonoscope is reusable.

[0054] Initialization of an intubated endoscope (i.e., an endoscope that has been inserted into the patient's anatomy) can be challenging. As described above, conventional methods are not suitable for docking an endoscope device that has been intubated or placed inside the patient, where the scope presents a tortuous shape of the path, because they are either not practical (requiring additional fixtures to place the endoscope in a tensioned fixture) or may potentially harm the patient (the instrument / colonoscope has to be moved to its limit).

[0055] The methods and systems herein can provide an improved docking method for an intubated colonoscope, thereby preventing trauma to the patient when coupling a robotic colonoscope to a robotic drive mechanism for robotic intracorporeal surgery.

[0056] Figure 12 An example of an algorithm 120 for initializing a robotic endoscope (e.g., a robotic colonoscope) to an instrument drive mechanism (IDM) is shown. In some embodiments, the robotic system can utilize the motor current from the IDM to sense the transmission load and utilize a wire (cable) in the robotic endoscope (e.g., colonoscope, gastroscope) to transmit motion.

[0057] The method can be applied to any suitable robotic endoscope system. The robotic endoscope system can be the same as the robotic endoscope system described in Figures 13 - 15 and / or Figures 7 - 11 As described in Figures 13 - 15As shown, a robotic endoscope (e.g., colonoscope, gastroscope) 1500 can be releasably coupled to an instrument drive mechanism 1320. The instrument drive mechanism 1320 can be mounted to the arm of the robotic support system 1300, or to any actuation support system described elsewhere herein. The instrument drive mechanism can provide a mechanical and electrical interface to the robotic endoscope 1500. The mechanical interface can allow the robotic endoscope 1110 to be releasably coupled to the instrument drive mechanism. For example, the handle portion 1501 of the robotic gastroscope can be attached to the instrument drive mechanism via a quick mount / release device (such as a magnet and spring-loaded wrench). In some cases, the robotic gastroscope can be manually coupled to or released from the instrument drive mechanism without the use of tools.

[0058] Figure 13 and Figure 14 An example of an instrument drive mechanism (IDM) 1320 that provides a mechanical interface to the handle portion of the robotic endoscope 1500 is shown. In some cases, the system can include an IDM 1320 for the robotic endoscope and one or more IDMs 1331, 1333 for one or more instruments (e.g., suturing instruments) attached to the robotic arm 1300. As shown in this example, the instrument drive mechanism (IDM) 1320 for the robotic endoscope 1500 can include a set of motors 1401 that are actuated to rotationally drive a set of wire ropes of a flexible robotic endoscope or catheter. The handle portion of the catheter assembly can be mounted on the instrument drive mechanism 1320 such that the winch of its pulley assembly or IDM interface 1511 is driven by the set of motors 1401. The number of pulleys can vary based on the wire rope configuration. In some cases, one, two, three, four, or more wire ropes can be used to articulate the bend section 1505 of the flexible robotic endoscope or catheter. Similarly, the instrument drive mechanism (IDM) 1331 for an instrument (e.g., suturing instrument) can include a set of motors that are actuated to rotationally drive a set of wire ropes of the instrument.

[0059] The handle portion can be designed to allow the robotic gastroscope to be disposable at a reduced cost. For example, a classic manual gastroscope and a robotic gastroscope can have a cable at the proximal end of the gastroscope handle. The cable typically includes an illumination fiber, a camera video cable, and other optional sensor fibers or cables (such as an electromagnetic (EM) sensor or a shape sensing fiber). Such complex cables can be expensive, increasing the cost of the gastroscope. The provided robotic gastroscope can have an optimized design so that a simplified structure and components can be adopted while retaining mechanical and electrical functions. In some cases, the handle portion of the robotic gastroscope can adopt a cable-free design while providing a mechanical / electrical interface for the catheter. The robotic scope can include a tip 1507 with an integrated component. Detailed information about the robotic endoscope and the distal tip will be described below.

[0060] Return to reference Figure 12 , the robotic manipulator can include an instrument drive mechanism (IDM) that accommodates multiple motors (e.g., four motors) to independently control each steering element in a matching robotic endoscope (e.g., a colonoscope). The robotic colonoscope can be the same as the robotic colonoscope described elsewhere herein. For example, the robotic colonoscope can have a long flexible shaft with a steerable distal tip and a proximal handle for coupling to the instrument drive mechanism (IDM). In some embodiments of the initialization process, the colonoscope can be initialized as an instrument drive mechanism by utilizing motor current from the IDM to sense the transmission load and utilizing a pull line (e.g., a cable) in the colonoscope to transmit motion.

[0061] Algorithm 1200 can allow slack to be removed in the antagonistic transmission of the flexible robotic curved segment 1210 while allowing the curved segment 1210 to conform to its original environment (e.g., the position, orientation and / or shape of the curved segment conforms to the curvature or tortuosity of the patient's anatomy).

[0062] The algorithm assumes that the degrees of freedom (DOF) are driven by two actuators in an opposing manner. For example, two wire ropes can be driven by two actuators respectively, corresponding to one degree of freedom (e.g., opposite directions). The two actuators can be independent and controlled by a control algorithm to tension and slacken the two wire ropes in coordination with each other. In some cases, both wire ropes are tensioned to set an initial tension state. In some cases, one wire rope is tensioned while the other is slack to effect movement. In some cases, both wire ropes can be slack to facilitate removal of the endoscopic device from a tortuous path by allowing the curved section to passively conform to the anatomical structure. In an alternative embodiment, one DOF can be driven by one actuator. For example, two wire ropes can be coupled to a driven pulley in an opposing manner to drive the movement of the curved section (i.e., move in one degree of freedom), such that when the pulley rotates in one direction, the rotation of the pulley will tension one wire rope and slacken the second wire rope.

[0063] As Figure 14 and Figure 15 shown, the colonoscope 1500 includes a handle 1501 for attachment to an IDM via an IDM interface 1511, a flexible elongate shaft 1503, and a manipulable curved section 1505. In the illustrated example, the colonoscope has four cable transmission lines (i.e., wire ropes) that terminate distally of the manipulable curved section and pass through the elongate shaft to a proximal winch 1513 housed in the handle. When the handle is attached to the IDM (as Figure 14 shown), the winch 1513 can be aligned with the output shaft 1403 of the IDM motor 1401 such that rotation of the output shaft will produce a corresponding rotation in the colonoscope winch. Rotation of the colonoscope winch in one direction will relieve cable tension, while rotation in the other direction will increase cable tension. In some cases, the cables in the distal portion of the colonoscope are spatially arranged such that a pair of cables (corresponding to one degree of freedom of the curved section, such as yaw) lies in a plane intersecting the neutral axis of the curved section. The other two cables can lie in an orthogonal plane intersecting the neutral axis of the curved section (e.g., pitch). A pair of cables corresponding to one degree of freedom can be driven by a pair of actuators (motors).

[0064] Initializing the colonoscope to the IDM can include: eliminating any slack present in the wire ropes (cables). As Figure 12As shown, the initialization algorithm 1200 may include commanding a pair of actuators to move in the tension direction respectively 1201. In some cases, the pair of actuators may move in their actuation directions at a constant speed while monitoring the applied load. The constant speed may be within a predetermined range to ensure rapid execution of the initialization process without damaging the cable. The predetermined range may be based on empirical data. In some cases, the constant speed may vary based on different bending section configurations (e.g., connection / layout of the wire ropes), and may be the same or different in different degrees of freedom (e.g., the constant speed related to pitch may be the same as or different from the constant speed related to yaw), or may be adjusted based on different usage applications. In some cases, the constant speed may be configured by the user through a user interface. Alternatively, the constant speed may be automatically adjusted or determined (e.g., automatically adjusted or determined during calibration before inserting the endoscope into the body of an object).

[0065] The system may monitor the applied load based on any suitable sensor data or measurements. In some embodiments, the system may monitor the applied load based on the motor current of each motor. This beneficially allows load measurement without the need for additional components.

[0066] Monitoring may include continuously determining whether the load difference (i.e., tension difference) in a pair of cables is greater than a predetermined "difference threshold" (e.g., small threshold 1202). If the tension difference is greater than the predetermined difference threshold, the actuator with the larger load pauses while the other actuator continues to move 1203. By continuously comparing the tension difference with the difference threshold or small threshold 1202 and adjusting the tension difference accordingly, the tension difference of the pair of cables can be maintained within an acceptable range, thereby maintaining the movement of the bending section / distal portion of the endoscope from its current position / orientation within an acceptable range. The small threshold 1202 may be predetermined based on empirical data. In some cases, the small threshold 1202 may vary based on different bending section configurations (e.g., connection / layout of the wire ropes), and may be the same or different in different degrees of freedom (e.g., the small threshold related to pitch may be the same as or different from the small threshold related to yaw), or may be adjusted based on different usage applications. In some cases, the small threshold may be configured by the user through a user interface. Alternatively, the small threshold may be automatically adjusted (e.g., automatically adjusted during calibration before inserting the endoscope into the body of an object).

[0067] As another actuator continues to move, the load difference or tension difference decreases, and when the detected tension difference is equal to or below the "difference threshold" 1204, the two actuators can return to move again in their actuation directions 1201. This process can be repeated to increase the load or tension in the pair of cables until the tension in at least one of the cables reaches (e.g., is detected to be equal to or greater than) a predetermined high threshold 1205. The high threshold can refer to a load threshold higher than the small threshold. The high threshold can be determined based on empirical data. In some cases, the high threshold 1205 can vary based on different bending section configurations (e.g., connection / layout of the wire ropes), and can be the same or different in different degrees of freedom (e.g., the high threshold related to pitch can be the same as or different from the high threshold related to yaw), or can be adjusted based on different usage applications (e.g., target site environment, etc.). In some cases, the high threshold can be configured by the user through a user interface. Alternatively, the high threshold can be automatically adjusted (e.g., automatically adjusted during calibration before inserting the endoscope into the subject's body).

[0068] If the tension in at least one of the cables reaches (e.g., is detected to be equal to or greater than) the predetermined high threshold, the corresponding actuator can stop moving while the other actuator continues to move until the tension also reaches the high threshold 1207. The algorithm can instruct the other actuator to stop moving, and the initialization process is completed.

[0069] In some cases, once the slack in a pair of cables (e.g., corresponding to the first degree of freedom) is eliminated, the above process can be repeated for another pair of cables (e.g., corresponding to the second degree of freedom). In some cases, the process can be performed simultaneously on two or more DOFs to reduce the total initialization time. Alternatively, the process can be performed sequentially on different degrees of freedom to avoid crosstalk between DOFs during initialization.

[0070] The above algorithm can beneficially eliminate the slack present in the wire ropes or cables while placing the bending section or robotic colonoscope inside the subject's body. The above method may not require knowledge of the initial (current) shape, orientation, or position of the robotic colonoscope. Although the above algorithm is described in the context of the robotic or colonoscope intubation process, it should be noted that when it is desired to initialize the scope while placing the robotic scope inside the subject's body, the above algorithm can be executed or applied in any scenario regardless of the type of scope. For example, during a surgical procedure, if the operation of the system is paused due to safety reasons or any type of failure, the robotic scope can be initialized from its current position / orientation by performing the above method without damaging the tissue.

[0071] Reduced-size sheath device

[0072] As Figure 1 described during the intubation process of, for example, it may be difficult to intubate the second scope (e.g., robotic endoscope, gastroscope) into or insert it into the transverse colon because the size or stiffness of the second scope may be different from that of the first endoscope (e.g., standard colonoscope or manual scope). For example, the diameter of a gastroscope can be larger than that of a standard colonoscope (e.g., 18 mm vs. 13 mm), and a gastroscope can be stiffer and shorter compared to a standard colonoscope (e.g., 80 cm vs. 160 cm). Since there can be a large diameter difference (e.g., about 5 mm or more) between the second scope (e.g., robotic endoscope, gastroscope) and the first scope (e.g., standard colonoscope or manual scope), the outer sheath used to deliver the second scope must be large enough to accommodate the second scope. For example, the diameter of the outer sheath is greater than (>) the outer diameter of the second scope. However, attempting to intubate the colon with such an outer sheath and a first scope with a smaller diameter may pose potential risks and challenges. For example, the gap between the outer sheath and the standard colonoscope may cause the outer sheath to get stuck on the tissue and impede its advancement. Additionally, one challenge that users encounter when using a balloon-assisted outer sheath for intubation is the large size of the outer sheath device.

[0073] The present disclosure provides a novel outer sheath having a reduced size during initial intubation, which can be used with an endoscope or colonoscope to facilitate the insertion, manipulation, and retraction of the endoscope during colonoscopy, upper gastrointestinal (GI) tract endoscopy, gastroscopy, small bowel endoscopy, or other procedures. In some embodiments, the outer sheath herein can be capable of changing the dimensions of the internal space to allow scopes of different diameters to pass through. In particular, the present disclosure provides an outer sheath device having a reduced size for outer sheath intubation and having the ability to accommodate scopes of different diameters. In some cases, the outer diameter of the outer sheath during the initial intubation process can be smaller than the outer diameter of the outer sheath during the intubation of a larger scope. As used herein, the term "initial intubation" can refer to the intubation process using a scope with a smaller diameter (e.g., Figure 1 operation 101 in). For example, the outer sheath device can allow for dilation to deliver a scope larger in size than the scope used for initial intubation (e.g., gastroscope or robotic scope). In some cases, the dimensions of the internal space of the outer sheath for allowing the scope to pass through during the initial intubation process can be smaller than the internal space of the outer sheath during the intubation of a larger scope.

[0074] In one aspect of the present disclosure, a scalable outer cannula device with a reduced size is provided. The outer cannula device may have a generally tubular shape and may have a compact configuration. The outer cannula device may have a deformable elongate body to accommodate mirrors of different diameters. In some embodiments, the outer cannula device may be delivered inside an anatomical structure (e.g., the colon) of an object and have a first diameter (e.g., outer diameter or inner diameter) during the intubation process, and may expand radially to allow the diameter of the channel of the device to be greater than the first diameter of the mirror used for intubation.

[0075] In some cases, the outer cannula may be pleated along its diameter such that the relaxed state of the tube may include one or more pleats and create a temporary lumen with a smaller diameter. The lumen may refer to the space inside a generally tubular structure. As used herein, the term "lumen" may refer to the space inside a generally tubular structure, a partial lumen (i.e., the space inside a partial tubular structure (e.g., where the wall is not encapsulated)), or the space defined by a generally tubular structure having any suitable cross-sectional shape or size. The temporary lumen may allow a first mirror with a smaller diameter to pass through during intubation. In the active state, the inner diameter of the outer cannula may expand, eliminating the pleats to allow a second mirror (e.g., a gastroscope) to pass through. The active state may allow an object larger than the sheath in the relaxed state (e.g., a gastroscope) to be inserted. The pleated sheath may expand around the larger object, allowing it to pass through and conform to the diameter of the object.

[0076] Figure 2 An example 200 of a scalable outer cannula device for intubation is shown. The outer cannula device 201 may be a pleated, radially expandable outer cannula. In some cases, the outer cannula device 201 may have a flat tube configuration, where the inner diameter of the flat tube is large enough for a second mirror (e.g., a gastroscope) 203 to pass through. The scalable outer cannula 201 may be shaped to surround the endoscope 203 without completely encapsulating the endoscope 203, where the pleated feature may allow the outer cannula to accommodate mirrors of different diameters. As shown in this example, the pleated feature may be along the axial direction of the flat tube configuration to allow the flat tube configuration to expand radially.

[0077] Figure 3A and Figure 3B An example 300 of another scalable outer cannula including a folding feature is shown. The outer cannula 300 may include a temporary longitudinal seam 302. In some cases, the outer cannula may be configured to roll up or fold along its longitudinal axis to create a temporary lumen (or a split partial lumen) 305 for engaging a first mirror (e.g., a smaller mirror 311 with a smaller diameter, e.g., a standard colonoscope) used for initial intubation.

[0078] As Figure 3BAs shown, during initial intubation 310, the outer sheath can be folded to engage a standard colonoscope shaft 311. The flat outer sheath configuration can provide a geometry that can wrap around the colonoscope shaft to access anatomical structures. By wrapping around the standard colonoscope during initial intubation, the outer diameter of the flat outer sheath is reduced. In some cases, the folding or rolling up of the flat outer sheath can form a lumen that can be located at the tip of the scope or at a defined location along the axis of the scope. The folding feature or rolling up feature can be located at discrete locations or can be continuous. Figure 3C An example of one or more clip features 307 located at discrete positions along the length is shown, which cause the outer sheath to form a generally tubular lumen for initial intubation. The folding feature or rolling up feature 307 can beneficially adjust the size of the tubular lumen, such as by holding the lumen on a smaller diameter scope during initial intubation and then allowing the lumen to expand to receive a larger diameter scope.

[0079] Return reference Figure 3B , in some embodiments, the outer sheath can include a main lumen 301 and a temporary lumen 305. The size (e.g., diameter) of each lumen can be adjusted. For example, the diameter of the second lumen (e.g., main lumen 301) is adjusted by folding / unfolding the first lumen (e.g., temporary lumen 305). During the process 320 of intubating a larger scope 313, the second lumen (e.g., main lumen 301) can be adapted to receive the larger scope. In some cases, the standby state of the flat tube can be rolled up along its longitudinal axis such that the roll forms the temporary lumen 305 through which a first scope (e.g., standard colonoscope 311) can be inserted (as Figure 3B shown). The smaller colonoscope 311 can engage the outer surface 303 rather than the inner surface of the temporary lumen 305 of the flat tube. The channel diameter of the main lumen 301 is at least adjusted or determined by the temporary lumen 305. The larger scope can be inserted into the main lumen 301 by contacting the inner surface 304 of the outer sheath or by unfolding the temporary lumen 305. The assembled outer sheath and the standard colonoscope 311 can together form an insertion diameter (outer diameter) that is less than the diameter when the colonoscope is placed inside the outer sheath.

[0080] The temporary lumen 305 can engage a first scope (e.g., standard colonoscope or smaller scope) for performing the initial intubation 310. Once the assembled first scope and outer sheath reach the target site as described in Figure 1 , the first scope can be withdrawn, and a second scope 313 (e.g., gastroscope or larger scope) can be placed through the main lumen of the outer sheath until the second scope 313 reaches the target site 320.

[0081] In some embodiments, the dimensions of the tubular structure of the outer sheath device can be adjusted based on the collapsible configuration of the tube. For example, by unfolding the flat main lumen configuration, the main lumen 301 can be expanded to receive a larger scope. In some cases, the edges 309 of the collapsible configuration can be releasably coupled (to form a roll). In some cases, the edges of the collapsible configuration can be separable but actively engage. Alternatively, the edges of the collapsible configuration can be separable but passively positioned relative to each other. The folding features can include passive engagement features, active engagement features, or a combination of passive and active engagement features and various other features.

[0082] In some cases, passive folding features (passive engagement features) can be employed to produce a desired fold in the standby state. For example, the passive folding features can include one or more split ring (e.g., the split ring clip 205 in Figure 2 ) positioned along the length of the flat tube, which is closed in the standby state. Figure 3C An example of one or more clip features 307 is shown, which form the outer sheath into a generally tubular lumen for initial intubation. In another example, the passive folding features can include a separable or peelable double lumen, where each lumen is firmly attached to one edge of the flat tube, and where separating the lumens from each other aids in unfolding the flat main lumen configuration. In yet another example, the passive folding features can include a separable or peelable thermal bond between the edges of the flat tube (or features attached to the flat tube). Various other passive features, such as slidably positioned rings or disks that can be removed from the flat tube, can also be used to allow the outer sheath to expand.

[0083] In some cases, the features of active engagement or active engagement features of the outer sheath can be utilized to produce a desired fold through energy. For example, the active engagement features can include one or more magnets attracting each other positioned along the edge of the flat tube or include iron-containing materials located on opposite sides. In another example, the features of active engagement can include a cable or wire that first passes through one lumen and then crosses over the lumen to be anchored in an adjacent lumen on the opposite flat edge, such that the tension in the cable pulls the flat edges towards each other to engage the scope. In yet another example, the active engagement features can include a cable or wire that passes through the eyelets on the alternating edges of the flat tube but is not anchored. Removing the cable or wire releases the flat tube to allow the flat tube to unfold. Other active engagement features, such as applying positive or negative pressure to a closed volume along the flat tube, can also be utilized, such that a positive pressure, a negative pressure, or a combination of both can promote the folding or unfolding of the flat tube lumen. It should be noted that the above examples are for illustrative purposes only and are not intended to be limiting.

[0084] The flexible outer sheath can be made of any suitable material (such as polyurethane, polypropylene, or polyethylene material). In some cases, a material (e.g., polyurethane) can be selected to be more easily bondable and to easily create seams via thermal welding or radio frequency welding. The various folding features (e.g., the slit ring clip 205) can be made of any suitable material such as polyurethane, polypropylene, polyethylene, polycarbonate, or any biocompatible semi-rigid material capable of withstanding the stresses required during the insertion of a larger colonoscope.

[0085] During intubation, the assembled colonoscope and the outer sheath can be advanced together through the colon to the target site. When the target site is reached, the balloon of the outer sheath can be inflated. Balloon inflation can allow the outer sheath to be anchored to the colon wall and can pull the outer sheath proximally to reduce the colon (e.g., shorten and straighten the colon). The first scope (e.g., the colonoscope) can be removed from the colon, and the second scope (e.g., the gastroscope) can be placed through the main lumen of the outer sheath to the target site.

[0086] In some cases, balloon inflation can serve as a release mechanism for the temporary lumen. For example, depending on the folding features of the outer sheath, balloon inflation can cause the deformation of the split ring at the distal end of the outer sheath, the initial separation of the peelable multi-lumen, the initial separation of the peelable thermal bond, the displacement of the magnet to disrupt its attraction, the displacement of the wire so that it no longer engages the hole, allowing the main lumen to expand, etc. The initial engagement with the first scope (e.g., the colonoscope) can be released via various other mechanisms that may or may not be related to balloon inflation. For example, fluid flowing through the filling lumen can cause the magnet to be displaced to eliminate the bond, or the magnets can be positioned in a state of mutual repulsion to create a positive separation state.

[0087] In an alternative embodiment, the outer sheath device can include a concentric, radially expandable and hardened outer sheath. The outer sheath device can include a concentric tubular structure with a hardening medium in the middle. The concentric tubes can have a smaller diameter for initial intubation. After the tube is placed at the target site, the inner tube can be pressurized, which causes the inner tube and the outer tube to expand radially. While the inner tube is pressurized, the space between the inner tube and the outer tube can be placed under vacuum so that the hardening medium between the inner tube and the outer tube locks in place relative to the surfaces of the expanded inner tube and outer tube. After the structure is hardened, the inner tube can be depressurized, and the rigid nature of the structure will prevent radial collapse. The hardening medium can include any suitable material or combination of materials, including but not limited to, a film with overlapping edges, a woven structure made of metal or plastic filaments, a foam with porosity and surface finish that contribute to hardening, or any other particulate medium.

[0088] In an alternative embodiment, the outer sheath device may employ a collapsible configuration to change the dimensions of the tubular structure. In some cases, the outer sheath device may include a flat outer sheath that is sealed at its distal end such that an internal volume can be placed under vacuum to reduce the outer profile of the outer sheath. The reduced outer profile is used to facilitate insertion of the outer sheath into the anatomical structure and to release the vacuum prior to replacing a first scope (e.g., a standard colonoscope) with a larger second scope (e.g., a gastroscope or a robotic scope).

[0089] Figure 4 and Figure 5 An example of an outer sheath device 400 including a collapsible outer sheath is shown. Figure 4 An example of an outer sheath 400 that reduces volume via internal vacuum during initial intubation is shown. The outer sheath can utilize the vacuum to eliminate the internal volume. As shown in this example, the internal space between the lumen layers can be reduced by the vacuum. Figure 5 An example of an outer sheath device including a collapsible outer sheath is shown.

[0090] In an alternative embodiment, the outer sheath device may include a multi-lumen configuration. In some cases, the outer sheath device may include a thin-walled multi-lumen configuration with suture folds.

[0091] Figure 6A An example of an outer sheath device 600 having a multi-lumen configuration is shown. In the illustrated example, the outer sheath may include a flat tube configuration with a dividing layer 611 that separates a smaller channel 601 from a larger channel 603. The smaller channel may form a first lumen for receiving a smaller scope, and the larger channel may form a second lumen for receiving a larger scope, where the first lumen and the second lumen have a common exit but variable dimensions. As shown in this example, the smaller channel 601 may be used to pass a smaller first scope (e.g., a colonoscope) 605, and the larger channel 603 may be capable of passing a larger second scope 607. The flexibility of the lumen separator (e.g., the dividing layer 611) allows the smaller channel to open for the smaller colonoscope for initial intubation and then collapse when the smaller colonoscope is not in use. Additionally, suture wires may be positioned and tensioned to keep the larger lumen in a collapsed state until the doctor desires to expand the larger lumen to pass the larger scope. Figure 6B The example in shows an example suture wire 609 that follows a spiral pattern to maintain the larger lumen. Various other suture positioning patterns relative to the lumen may be employed.

[0092] Flexible endoscope

[0093] The intubation method and device can be used in a robotic endoscopy system. In some cases, the intubation method and device herein can be applied to single-use or reusable robotic endoscopes. Traditionally, endoscopes are reusable and may need to be thoroughly cleaned, disinfected, and / or sterilized after each surgery. In most cases, cleaning, disinfection, and sterilization can be a strong germicidal and / or bactericidal process. Such procedures can also be harsh on the endoscope itself. Therefore, the design of such reusable endoscopes is usually likely to be complex, especially to ensure that the endoscope can withstand such harsh cleaning, disinfection, and sterilization regimens. Regular maintenance and repair of such reusable endoscopes may typically be required.

[0094] For instruments that are difficult to clean thoroughly, low-cost disposable medical devices designated for single use have become popular. Single-use disposable devices can be packaged in sterile wrapping to avoid the risk of pathogenic cross-infection of diseases such as HIV, hepatitis, and other pathogens. Hospitals generally readily accept the convenience of single-use disposable products as they no longer have to worry about product aging, overuse, breakage, malfunction, and sterilization. Traditional endoscopes typically include a handle for the operator to manipulate the endoscope. For single-use endoscopes, the handle generally encapsulates a camera, expensive electronics, and mechanical structures at the proximal end to transmit video and allow the user to manipulate the endoscope via a user interface. This can result in a high cost for the handle of single-use endoscopes.

[0095] In some embodiments, the outer cannula device and method provided herein can be used for intubating a flexible endoscope, which can be single-use or disposable. Alternatively, the flexible endoscope can be reusable. Figure 7 An example of a flexible endoscope 1000 in accordance with some embodiments of the present disclosure is illustrated. As Figure 7As shown, the flexible endoscope 1000 may include a handle / proximal portion 1009 and a flexible elongate member that will be inserted into an object. The flexible elongate member may be the same as the flexible elongate member 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 an anti-prolapse passive section 1004. The active bending section, the anti-prolapse passive section, and the proximal shaft section may be the same as the active bending section, the anti-prolapse passive section, and the proximal shaft section described elsewhere herein. The endoscope 100 may also be referred to as a steerable catheter assembly, as described elsewhere herein. In some cases, the 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 discarded. In some embodiments, the endoscope may include different levels of stiffness along its axis to improve functional operation.

[0096] The endoscope or steerable catheter assembly 1000 may include a handle portion 1009, which 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 between the steerable catheter assembly 1000 and any other external system or device. In another example, the handle portion 1009 may include circuit elements, such as a power source for powering the electronics of the endoscope (e.g., camera, electromagnetic sensor, and LED lights).

[0097] One or more components located at the handle may be optimized such that expensive and complex components may be allocated to the robotic support system, the handheld controller, or the instrument drive mechanism, thereby reducing costs and simplifying the design of the disposable endoscope. The handle portion or proximal portion may provide electrical and mechanical interfaces to allow for 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 wire ropes of the catheter. The handle portion of the catheter assembly may be fitted onto the instrument drive mechanism such that its pulley / winch assembly is driven by the set of motors. The number of pulleys may vary based on the wire rope configuration. In some cases, one, two, three, four, or more wire ropes may be used to articulate the flexible endoscope or catheter.

[0098] The handle portion can be designed to allow the robotic endoscope to be disposable at a reduced cost. For example, a classic manual endoscope and a robotic endoscope can have a cable at the proximal end of the endoscope handle. This cable typically includes illumination fibers, a camera video cable, and other sensor fibers or cables (such as electromagnetic (EM) sensors or shape-sensing fibers). Such a complex cable can be expensive, increasing the cost of the endoscope. The provided robotic endoscope can have an optimized design such that a simplified structure and components can be employed while retaining mechanical and electrical functions. In some cases, the handle portion of the robotic endoscope can adopt a cable-free design while providing a mechanical / electrical interface for the catheter.

[0099] The electrical interface (e.g., a printed circuit board) can allow image / video data and / or sensor data to be received by the communication module of the instrument drive mechanism, and the image / video data and / or sensor data can be transmitted to other external devices / systems. In some cases, the electrical interface can establish electrical communication without cables or wires. For example, the interface can include pins soldered to an electronic board such as a printed circuit board (PCB). For example, a socket connector (e.g., a female connector) is provided on the instrument drive mechanism as a mating interface. This can beneficially allow the endoscope to be quickly inserted into the instrument drive mechanism or the robotic support without using additional cables. This type of electrical interface can also be used as a mechanical interface such that when the handle portion is inserted into the instrument drive mechanism, both a mechanical coupling and an electrical coupling are established. As an alternative or in addition, the instrument drive mechanism can provide only a mechanical interface. The handle portion can communicate electrically with a modular wireless communication device or any other user device (e.g., a portable / handheld device or a controller) for transmitting sensor data and / or receiving control signals.

[0100] In some cases, the handle portion 1009 can include one or more mechanical control modules, such as a Luer interface 1011, for connecting a lavage system / suction system. In some cases, the handle portion can include a lever / knob for articulation control. Alternatively, the articulation control can be located at a separate controller attached to the handle portion via the instrument drive mechanism.

[0101] An endoscope can be attached to a robotic support system or a handheld controller via an instrument drive mechanism. The instrument drive mechanism can be provided by any suitable controller device (e.g., a handheld controller), which may or may not include a robotic system. The instrument drive mechanism can provide a mechanical and electrical interface to a steerable catheter assembly 1000. The mechanical interface can allow the steerable catheter assembly 1000 to be releasably coupled to the instrument drive mechanism. For example, the handle portion of the steerable catheter assembly can be attached to the instrument drive mechanism via a quick mount / release device (such as a magnet, a spring-loaded wrench, etc.). In some cases, the steerable catheter assembly can be manually coupled to or released from the instrument drive mechanism without the use of tools. Details regarding the instrument drive mechanism will be described hereinafter.

[0102] In the illustrated example, the distal tip of the catheter or endoscope shaft is configured to articulate / bend in two or more degrees of freedom to provide a desired camera view or to control the orientation 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 of the catheter or endoscope shaft 1005. For example, the line of sight of the camera can be controlled by controlling the articulation of the active bending section 1003. In some cases, the angle of the camera can be adjustable such that the line of sight can be adjusted without articulating the distal tip of the catheter or endoscope shaft or in addition to articulating the distal tip of the catheter or endoscope shaft. For example, the camera can be oriented (e.g., tilted) at an angle relative to the axial direction of the endoscope tip by means of an optical component.

[0103] The distal tip 1005 can be a rigid component that allows sensors (such as electromagnetic (EM) sensors), imaging devices (e.g., cameras), and other electronic components (e.g., LED light sources) to be positioned and embedded at the distal tip.

[0104] In real-time EM tracking, an EM sensor, which consists of one or more sensor coils in one or more positions and orientations (e.g., the tip of an endoscopic tool) embedded in a medical device, measures changes in the EM field generated by one or more static EM field generators positioned at locations near the patient. The position information detected by the EM sensor is stored as EM data. The EM field generator (or transmitter) can be placed near the patient to generate a low-intensity magnetic field that can be detected by the embedded sensor. This magnetic field induces small currents in the sensor coils of the EM sensor, and these small currents can be analyzed to determine the distance and angle between the EM sensor and the EM field generator. For example, the EM field generator can be positioned near the patient's torso during surgery to localize the position of the EM sensor in 3D space or to localize the position and orientation of the EM sensor in 5D or 6D space. This can provide visual guidance to the operator when driving the endoscope towards the target site.

[0105] The elongate member of the endoscope can have a unique design. In some cases, the active bending section 1003, the anti-prolapse passive section, and the proximal shaft of the endoscope can consist of a single tube that includes a series of incisions (e.g., notches, slits, etc.) along its length to allow for improved flexibility, desired stiffness, and anti-prolapse features (e.g., features for defining a minimum bending radius).

[0106] As described above, the active bending section 1003 can be designed to allow bending (e.g., articulation) in two or more degrees of freedom. A greater degree of bending, such as 180 degrees and 270 degrees (or other articulation parameters for clinical indications), can be achieved through the unique structure of the active bending section, while kinking or prolapse can be prevented by the passive section following the active bending section. In some cases, the active bending section and / or the passive section can be manufactured 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 can be different, such that at least the minimum bending radii of the two sections can be different. In some cases, a variable minimum bending radius can be provided along the axial axis of the elongate member, such that the active bending section or the passive section can include two or more different minimum bending radii.

[0107] The articulation of the endoscope can be controlled by applying a force via one or more pull wires to the distal end of the endoscope. One or more pull wires can be attached to the distal end of the endoscope. In the case of multiple pull wires, pulling one wire at a time can change the orientation of the distal tip to tilt it up, down, left, right, or in any desired direction. In some cases, the pull wires can be anchored at the distal tip of the endoscope, travel through the bending section, and enter the handle, where the pull wires are coupled to a drive assembly (e.g., a pulley). This handle pulley can interact with the output shaft from a robotic system.

[0108] In some embodiments, the proximal end or proximal portion of one or more pull wires can be operably coupled to respective mechanisms (e.g., gears, pulleys, winches, etc.) in the handle portion of the catheter assembly. The pull wire can be a wire, cable, or filament of metal, or it can be a wire, cable, or filament of polymer. The pull wire can also be made of natural or organic materials or fibers. The pull wire can be any suitable type of wire, cable, or filament capable of supporting various loads without deforming, significantly deforming, or breaking. The distal end / distal portion of one or more pull wires can be anchored or integrated into the distal portion of the catheter such that operation of the pull wire by the control unit can apply a force or tension to the distal portion, which can manipulate or articulate (e.g., up, down, pitch, yaw, or in any direction therebetween) at least the distal portion (e.g., the flexible segment) of the catheter.

[0109] The pull wire can be made of any suitable material such as stainless steel (e.g., SS316), metal, alloy, polymer, nylon, or biocompatible material. The pull wire can be a wire, cable, or filament. In some embodiments, different pull wires can be made of different materials to vary the load-bearing capacity of the pull wire. In some embodiments, different segments of the pull wire can be made of different materials to vary the stiffness and / or load-bearing capacity along the pull wire. In some embodiments, the pull wire can be used for the transmission of electrical signals.

[0110] The proximal design can improve the reliability of the device without introducing additional cost, thereby allowing 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 gastroscope and can be the same as the steerable catheter assembly described elsewhere herein. Conventional endoscopes can be complex in design and are generally designed for reuse after surgery, which requires thorough cleaning, disinfection, or sterilization after each surgery. Existing endoscopes are typically designed with complex structures to ensure that the endoscope can withstand the cleaning, disinfection, and sterilization processes. The provided robotic endoscope can be a single-use endoscope, which can beneficially reduce cross-contamination between patients and infected persons. In some cases, the robotic gastroscope can be delivered to a medical practitioner in a pre-sterilized package and is intended to be discarded after single use.

[0111] As Figure 8 shown, the robotic gastroscope 1120 can include a handle portion 1113 and a flexible elongate member 1111. In some embodiments, the flexible elongate member 1111 can include a shaft, a steerable tip, a steerable / active bending section, and an anti-prolapse passive section. The robotic gastroscope 1120 can be the same as Figure 7is the same as the steerable catheter assembly described in. The robotic gastroscope can be a single-use robotic endoscope. In some cases, only the catheter can be disposable. In some cases, at least a portion of the catheter can be disposable. In some cases, the entire robotic gastroscope can be released from the instrument drive mechanism and discarded. In some cases, the gastroscope can include different levels of stiffness along its axis to improve functional operation. In some cases, the minimum bend radius along the axis can vary such that the kink resistance or anti-prolapse ability can be configurable along the length.

[0112] The robotic gastroscope can be releasably coupled to the instrument drive mechanism 1120. The instrument drive mechanism 1120 can be mounted to the arm of the robotic support system or can be mounted to any actuated support system as described elsewhere herein. The instrument drive mechanism can provide a mechanical and electrical interface to the robotic gastroscope 1110. The mechanical interface can allow the robotic gastroscope 1110 to be releasably coupled to the instrument drive mechanism. For example, the handle portion of the robotic gastroscope can be attached to the instrument drive mechanism via a quick mount / release device (such as a magnet and spring-loaded wrench). In some cases, the robotic gastroscope can be manually coupled to or released from the instrument drive mechanism without the use of tools.

[0113] Figure 9 An example of an instrument drive mechanism 1220 is shown that provides a mechanical interface to the handle portion 1213 of a robotic endoscope. As shown in this example, the instrument drive mechanism 1220 can include a set of motors that are actuated to rotationally drive a set of wire ropes of a flexible endoscope or catheter. The handle portion 1213 of the catheter assembly can be mounted to the instrument drive mechanism such that its pulley assembly or winch is driven by the set of motors. The number of pulleys can vary based on the wire rope configuration. In some cases, one, two, three, four, or more wire ropes can be used to articulate the flexible endoscope or catheter.

[0114] The handle portion can be designed to allow the robotic gastroscope to be used once at a reduced cost. For example, a classic manual gastroscope and a robotic gastroscope can have a cable at the proximal end of the gastroscope handle. This cable typically includes illumination fibers, a camera video cable, and other sensor fibers or cables (such as electromagnetic (EM) sensors or shape-sensing fibers). Such a complex cable can be expensive, increasing the cost of the gastroscope. The provided robotic gastroscope can have an optimized design such that a simplified structure and components can be employed while retaining mechanical and electrical functionality. In some cases, the handle portion of the robotic gastroscope can employ a cableless design while providing a mechanical / electrical interface to the catheter.

[0115] Figure 10An example of the distal tip 1300 of an endoscope is shown. In some cases, the distal portion or tip of the catheter 1300 can be substantially flexible such that it can be maneuvered in one or more directions (e.g., pitch, yaw). The catheter can include a tip portion, a bend section, and an insertion shaft. In some embodiments, the catheter can have a variable bending stiffness along the longitudinal axis direction. For example, the catheter can include multiple segments having different bending stiffnesses (e.g., flexible, semi-rigid, and rigid). The bending stiffness can be varied by selecting materials with different stiffness / rigidity, changing the structure (e.g., cuts, patterns) in different sections, adding additional support components, or any combination of the above. In some embodiments, the catheter can have a variable minimum bending radius along the longitudinal axis direction. Selecting different minimum bending radii at different positions along the catheter can beneficially provide anti-prolapse capabilities while still allowing the catheter to reach difficult-to-access areas. In some cases, the proximal end of the catheter does not need to be highly bent, so the proximal portion of the catheter can be reinforced with additional mechanical structures (e.g., additional material layers) to achieve greater bending stiffness. This design can provide support and stability to the catheter. In some cases, the variable bending stiffness can be achieved by using different materials during the extrusion of the catheter. This can advantageously allow for different stiffness levels along the axis of the catheter during the extrusion manufacturing process without additional fastening or assembly of different materials.

[0116] The distal portion of the catheter can be maneuvered by one or more pull wires 1305. The distal portion of the catheter can be made of any suitable material (such as a copolymer, polymer, metal, or alloy) such that it can be bent by the pull wires. In some embodiments, the proximal end or terminus of one or more pull wires 1305 can be coupled to a drive mechanism (e.g., gears, pulleys, winches, etc.) via an anchoring mechanism as described above.

[0117] The pull wires 1305 can be metal wires, cables, or filaments, or they can be polymer wires, cables, or filaments. The pull wires 1305 can also be made of natural or organic materials or fibers. The pull wires 1305 can be any type of suitable wire, cable, or filament capable of supporting various loads without deforming, deforming significantly, or breaking. The distal end or distal portion of one or more pull wires 1305 can be anchored or integrated into the distal portion of the catheter such that the operation of the pull wires by the control unit can apply a force or tension to the distal portion, which can maneuver or articulate (e.g., up, down, pitch, yaw, or in any direction therebetween) at least the distal portion (e.g., the flexible segment) of the catheter.

[0118] The size of the catheter can enable one or more electronic components to be integrated into the catheter. For example, the outer diameter of the distal tip can be about 4 to 4.4 millimeters (mm), and the diameter of the working channel 1303 can be about 2 mm, such that one or more electronic components can be embedded in the wall of the catheter. However, it should be noted that based on different applications, the outer diameter can be in any range less than 4 mm or greater than 4.4 mm, and the diameter of the working channel can be in any range depending on the tool size or the specific application.

[0119] One or more electronic components can include an imaging device, a lighting device, or a sensor. In some embodiments, the imaging device can be a video camera 1313. The imaging device can include optical elements and an image sensor for capturing image data. The image sensor can be configured to generate image data in response to the wavelength of light. Various image sensors (such as complementary metal oxide semiconductor (CMOS) or charge-coupled device (CCD)) can be employed to capture image data. The imaging device can be a low-cost camera. In some cases, the image sensor can be provided on a circuit board. The circuit board can be an imaging printed circuit board (PCB). The PCB can include multiple electronic components for processing the image signal. For example, the circuit for a CCD sensor can include an A / D converter and an amplifier to amplify and convert the analog signal provided by the CCD sensor. Optionally, the image sensor can be integrated with the amplifier and converter to convert the analog signal into 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 can be image data (digital signal) that can be further processed by the camera circuit or the processor of the camera. In some cases, the image sensor can include an array of optical sensors.

[0120] The lighting device can include one or more light sources 1311 located at the distal tip. The light source can 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 can be a small LED or a dual-tone flash LED lighting for a compact design.

[0121] The imaging device and the lighting device can be integrated into the catheter. For example, the distal portion of the catheter can include a suitable structure that matches at least one dimension of the imaging device and the lighting device. The imaging device and the lighting device can be embedded in the catheter. Figure 11An example distal portion of a catheter having an integrated imaging device and illumination device is shown. A camera can be located at the distal portion. The distal tip can have a structure for receiving the camera, illumination device, and / or position sensor. For example, the camera can be embedded in a cavity 1410 at the distal tip of the catheter. The cavity 1410 can be integrally formed with the distal portion of the cavity and can have dimensions that match the length / width of the camera such that the camera cannot move relative to the catheter. The camera can 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 can be controlled by controlling the rotational movement (e.g., rolling) of the catheter.

[0122] Power for the camera can be provided by a wired cable. In some cases, the cable can be in a harness that provides power for the camera as well as illumination elements or other circuitry at the distal tip of the catheter. The camera and / or light source can be powered by a power source located at the handle portion via a wire, copper wire, or via any other suitable means that travels through the length of the catheter. In some cases, real-time images or videos of the tissue or organ can be wirelessly transmitted to an external user interface or display. The wireless communication can be WiFi, Bluetooth, RF communication, or other forms of communication. In some cases, the images or videos captured by the camera can be broadcast to multiple devices or systems. In some cases, the image and / or video data from the camera can be transmitted along the length of the catheter via a wire, copper wire, or via any other suitable means to a processor located in the handle portion. The image or video data can be transmitted to an external device / system via a wireless communication component in the handle portion. In some cases, the system can be designed such that the wire is not visible to the operator or the wire is not exposed to the operator.

[0123] In conventional endoscopy, the illumination light can be provided by an optical fiber cable that transmits the 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, small LED lights can be employed and embedded in the distal portion of the catheter to reduce design complexity. In some cases, the distal portion can include a structure 1430 that has dimensions that match the size of the small LED light source. As shown in the illustrated example, two cavities 1430 can be integrally formed with the catheter to receive two LED light sources. For example, the outer diameter of the distal tip can be about 4 to 4.4 millimeters (mm), and the diameter of the working channel of the catheter can be about 2 mm such that the two LED light sources can be embedded at the distal end. The outer diameter can be in any range less than 4 mm or greater than 4.4 mm, and the diameter of the working channel can be in any range depending on the size of the tool or the specific application. Any number of light sources can be included. The internal structure of the distal portion can be designed to accommodate any number of light sources.

[0124] In some cases, each LED can be connected to a power line that can extend to the proximal handle. In some embodiments, the LEDs can be soldered to separate power lines that are then bundled together to form a single strand. In some embodiments, the LEDs can be soldered to a pull wire that supplies power. In other embodiments, the LEDs can be crimped or directly connected to a single pair of power lines. In some cases, a protective layer such as a thin layer of biocompatible glue can be applied to the front surface of the LEDs to provide protection while allowing light to emit. In some cases, an additional cap 1431 can be placed at the forward end face of the distal tip, thereby providing precise positioning of the LEDs and sufficient space for the glue. The cap 1431 can be composed of a transparent material that matches the refractive index of the glue such that the illumination light can pass through unobstructed.

[0125] The working channels (e.g., working channels 1303, 1420) can be designed to provide protection for internal components such as flexible instruments (e.g., needles, forceps, etc.). When a flexible instrument passes through a conventional working channel, the flexible instrument may be blocked by the working channel due to kinking, ovalization, and / or high friction. The working channels herein can advantageously address the above disadvantages by providing high circumferential strength and the ability to achieve a low bending radius. The working channels can also be designed to provide low friction on the inner surface.

[0126] Figure 16 Another example of the tip 1507 of a robotic endoscope device is shown. The tip 1507 can include the same image sensor 1613 and light source 1611 as those described above. The tip can further include other features such as lens cleaning and forward flushing to provide a clear camera view. The working channels (e.g., instrument channel 1601, auxiliary channel 1615) can be designed to provide protection for internal components such as flexible instruments (e.g., suture instruments, forceps, etc.). When a flexible instrument passes through a conventional working channel, the flexible instrument may be blocked by the working channel due to kinking, ovalization, and / or high friction. The working channels can provide high circumferential strength and have the ability to achieve a low bending radius. The inner surface of the working channels can also be designed to provide low friction. The suture instruments described herein can pass through the working channels and extend out from the distal tip of the endoscope or retract into the working channels.

[0127] Although the 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. Many 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. The appended claims are intended to define the scope of the invention and are intended to cover methods and structures within the scope of these claims and their equivalents.

Claims

1. An apparatus for inserting an endoscope into a subject, the apparatus comprising: A flexible outer cannula, the flexible outer cannula comprising features to form a first lumen for a first scope to pass through during cannulation, wherein the first lumen is deformable to create a second lumen for a second scope to pass through, wherein the second scope has a larger diameter than the first scope.

2. The apparatus according to claim 1, wherein the diameter of the first lumen is smaller than the diameter of the second lumen.

3. The apparatus according to claim 1, wherein the feature comprises an expandable tubular structure for adjusting the size of the first lumen or the second lumen.

4. The apparatus according to claim 3, wherein the expandable tubular structure is a flat tube configuration having pleats along an axial direction.

5. The apparatus according to claim 3, wherein the expandable tubular structure is a collapsible flat tube configuration.

6. The apparatus according to claim 5, wherein the collapsible flat tube configuration has separable edges that are joined by one or more active engagement features.

7. The apparatus according to claim 5, wherein the collapsible flat tube configuration adjusts the diameter of the first lumen by one or more passive engagement features to create the second lumen.

8. The apparatus according to claim 1, wherein the first lumen and the second lumen are two channels separated by a lumen separator of the flexible outer sheath.

9. The apparatus according to claim 1, wherein the second mirror is a robotic mirror.

10. The apparatus according to claim 9, wherein the robotic mirror includes a handle portion releasably coupled to a robotic support.

11. The apparatus according to claim 10, wherein after the robotic mirror is inserted into the second lumen in a zigzag shape, the handle portion of the robotic mirror is coupled to the robotic support.

12. The apparatus according to claim 11, wherein the robotic mirror is initialized by eliminating slack in one or more wire ropes used to control articulation of the curved section while the curved section of the robotic mirror conforms to the internal environment within the subject.

13. A method for inserting a robotic endoscope into a subject, the method comprising: (a) Performing an initial cannulation using the first scope and the cannula device to reach a target site within the body of the subject, wherein the first scope is engaged with the first lumen of the cannula device; (b) Withdrawing the first scope and inserting a second scope into the second lumen of the cannula device to reach the target site, wherein the second scope is a robotic scope, the robotic scope having a larger diameter than the first scope; and (c) Coupling a handle portion of the second scope to an instrument drive mechanism (IDM) and initializing the second scope while the second scope is within the body of the subject.

14. The method according to claim 13, wherein the initialization includes eliminating slack in one or more wire ropes of the second mirror.

15. The method according to claim 14, wherein the one or more tension cables are driven by the IDM to control the articulation of the curved section of the second mirror in one or more degrees of freedom.

16. The method according to claim 15, further comprising monitoring the tension in the one or more tension cables corresponding to one degree of freedom.

17. The method according to claim 16, further comprising comparing the difference in the tension in the one or more tension cables with a predetermined threshold.

18. The method according to claim 17, further comprising controlling one or more actuators of the IDM based on the tension or the difference in the tension.

19. The method according to claim 13, wherein the first lumen is deformable to create a second lumen.

20. The method according to claim 13, wherein the outer sheath device comprises an expandable tubular structure to adjust the size of the first lumen or the second lumen.

21. The method according to claim 20, wherein the expandable tubular structure is a flat tube configuration having pleats along an axial direction.

22. The method according to claim 20, wherein the expandable tubular structure is a collapsible flat tube configuration.

23. The method according to claim 13, wherein the first lumen and the second lumen are two channels separated by a lumen separator of the outer sheath device.

24. A method for initializing a robotic endoscope inside an object, the method comprising: (a) Driving a pair of wire lines at a constant speed by an instrument drive mechanism while the robotic endoscope is placed inside the subject, wherein the pair of wire lines are actuated to control the articulation of a bending section of the robotic endoscope corresponding to a first degree of freedom; (b) Comparing a difference in tension in the pair of wire lines with a first threshold and changing the movement of the pair of wire lines when the first threshold is reached to reduce the difference in tension; and (c) Comparing the tension in the pair of wire lines with a second threshold and stopping the movement of the respective wire line when the tension in any one of the pair of wire lines reaches the second threshold.

25. The method according to claim 24, wherein the second threshold is higher than the first threshold.

26. The method according to claim 24, wherein (a)-(c) are repeated for a pair of tension cables corresponding to a second degree of freedom.

27. The method according to claim 26, wherein (a)-(c) are performed simultaneously for the first degree of freedom and the second degree of freedom.

28. The method according to claim 26, wherein (a)-(c) are performed sequentially for the first degree of freedom and the second degree of freedom.

29. The method according to claim 24, wherein the robotic mirror comprises a handle portion releasably coupled to the instrument drive mechanism.

30. The method according to claim 29, wherein the instrument drive mechanism is supported by an end effector of a robotic arm.

31. The method according to claim 24, wherein the robotic mirror includes a flexible elongate member, and the current shape, position or orientation of the elongate member is unknown.

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