System and method for robotic intraluminal suturing device

Abstract

A suturing device is provided. The suturing device comprises a flexible shaft having an articulated bend, and a needle end effector located at the distal end of the bend. The needle end effector includes a rotary mechanism of a toggle base that switches the orientation of the needle so that the needle engages with and disengages from a ferrule.

Description

Technical Field

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 489,258, filed on March 9, 2023, the entire contents of which are incorporated herein by reference.

Background Art

[0002] In an endoscopy procedure, an endoscope is used to examine the interior of a hollow organ or cavity of the body. Unlike many other medical imaging techniques, an endoscope is inserted directly into an organ through the mouth or other natural openings. Flexible endoscopes that can achieve intuitive manipulation and control are useful in diagnosing and treating diseases that can be reached through any natural opening of the body. Depending on the clinical symptoms, an endoscope can be designated as a colonoscope, gastroscope, bronchoscope, ureteroscope, ENT scope, and various others. For example, a flexible colonoscope can be inserted into the transverse colon for diagnosis and / or surgical procedures.

[0003] Endoscopes have traditionally been made to be reusable and may require thorough cleaning, disinfection, and / or sterilization after each procedure. In most cases, cleaning, disinfection, and sterilization can be an aggressive process that kills pathogenic and / or bacteria. Such procedures can also be a burden on the endoscope itself. Therefore, the design of such reusable endoscopes can often be complex, especially to ensure that the endoscope can withstand such burdensome cleaning, disinfection, and sterilization protocols. Regular maintenance and repair for such reusable endoscopes can often be required.

[0004] Low-cost, single-use, disposable medical devices are becoming popular for instruments that are difficult to properly clean. Single-use disposable devices may be packaged in sterile packaging to avoid the risk of pathogenic cross-contamination from diseases such as HIV, hepatitis, and other pathogens. Hospitals generally welcome the convenience of single-use disposable products because they no longer require concern about product lifespan, overuse, breakage, malfunction, and sterilization. Conventional endoscopes often feature a handle used by the operator to control the endoscope. In the case of single-use endoscopes, the handle typically includes a camera, expensive electronics, and mechanical structures at the proximal end, for transmitting video and allowing the user to control the endoscope via a user interface. This can make the handle costly in the case of single-use endoscopes.

[0005] The endoscopic device may have a working channel through which tools such as grippers, cutters, or suturing instruments can pass. In another example, a suturing instrument can be attached to the distal end of the endoscope, thereby enabling suturing in the patient's gastroesophageal tube. However, current suturing instruments are designed for manual endoscopic devices such as laparoscopy. For clinicians, it is desirable to have suturing instruments that are suitable for robotic endoscopic platforms or that are miniaturized and have improved motion control for use in luminal tissues.

[0006] One aspect of the present disclosure provides a suturing device comprising a flexible shaft having an articulated bend, and a needle end effector located at the distal end of the articulated bend, the needle end effector having a rotating mechanism on a toggle base that switches the orientation of the needle so that the needle engages with and disengages from a ferrule.

[0007] In some embodiments, the needle rotates back and forth over a predetermined angular range with respect to an axial axis to change its orientation. In some cases, the predetermined angular range is about 60°. In some embodiments, the toggle base rotation mechanism comprises a plate with a plurality of channels formed thereon that guide the switching of the needle's orientation. In some cases, the plurality of channels are formed on a substantially flat surface of the plate. In some embodiments, the toggle base rotation mechanism comprises a spring-biased toggle that switches the needle from a channel inclined with respect to the axial axis of the needle end effector to a channel parallel to the axial axis of the needle end effector. In some embodiments, the toggle base rotation mechanism comprises an antagonist cable that drives the forward and backward movement of the needle.

[0008] In some embodiments, the length of the needle end effector is 30 mm or less. In some embodiments, the diameter of the needle end effector is 5 mm or less. In some embodiments, the needle end effector is rotatable relative to the articulated bending portion. Alternatively, the needle end effector is fixedly connected to the articulated bending portion.

[0009] In some embodiments, an articulable flex section is actuated by one or more tension wires, the proximal ends of which are connected to the handle of the suturing instrument. In some cases, a cable that drives the translational motion of the needle is connected to the handle. In some cases, the handle is releasably connected to a robotic support via a first instrument drive mechanism. In some cases, the first instrument drive mechanism drives the articulation of the articulable flex section and the operation of the needle end effector.

[0010] In some embodiments, suturing instruments are inserted through the working channel of a flexible robotic endoscope. In some cases, the flexible robotic endoscope includes an articulated bending section. In some cases, the flexible robotic endoscope is releasably connected to a robotic support via a second instrument drive mechanism. For example, the articulated bending section is actuated by the second instrument drive mechanism.

[0011] In another embodiment, a robotic intraluminal suturing device is provided. The robotic intraluminal suturing device comprises a flexible shaft having an articulated bend, the articulation of which is driven by one or more tension wires; a needle end effector connected to the distal end of the articulated bend, the needle end effector having a needle that is driven by a cable to translate and rotate to engage and disengage with a ferrule; and a handle configured to releasably connect the robotic intraluminal suturing device to an instrument drive mechanism, the instrument drive mechanism acting on one or more tension wires and cables.

[0012] In some embodiments, the length of the needle end effector is 30 mm or less. In some embodiments, the diameter of the needle end effector is 5 mm or less.

[0013] In some embodiments, the needle end effector is rotatable relative to an articulated bending portion. In some embodiments, the needle end effector is fixedly connected to the articulated bending portion. In some embodiments, the needle rotates back and forth over a predetermined angular range with respect to an axial axis to change the orientation of the needle. In some cases, the predetermined angular range is about 60°.

[0014] In some embodiments, the needle end effector includes a rotary mechanism for a toggle base that switches the direction of the needle. In some cases, the rotary mechanism for the toggle base includes a plate with multiple channels formed therein that guide the switching of the needle's direction. In some cases, the multiple channels are formed on a substantially flat surface of the plate.

[0015] In some embodiments, robotic intraluminal suturing instruments are inserted through the working channel of a flexible robotic endoscope. In some cases, the flexible robotic endoscope has articulated bends and is releasably connected to a robotic support.

[0016] Reference All publications, patents, and patent applications referenced herein are incorporated herein by reference to the same extent that each individual publication, patent, or patent application is specifically and individually referred to. To the extent that any publications, patents, or patent applications incorporated herein by reference conflict with any disclosures contained herein, this specification is intended to supersede and / or take precedence over any such conflict. [Brief explanation of the drawing]

[0017] Novel features of the present invention are described in detail in the appended claims. The features and advantages of the present invention will be better understood by referring to the following detailed description, which describes exemplary embodiments in which the principles of the present invention are utilized, and to the appended drawings (hereinafter also referred to as "Figure" and "FIG.").

[0018] [Figure 1] This is a schematic diagram showing an example of a suturing device. [Figure 2] This figure shows an example of an end effector that employs a toggle-based rotary indexing mechanism. [Figure 3] This figure shows an example of a needle drive mechanism. [Figure 4A] This figure shows an example of an indexing mechanism. [Figure 4B] This figure shows an example of an indexing mechanism. [Figure 5A] This figure shows an example of a needle end effector with a compact design. [Figure 5B] This figure shows an example of a needle end effector with a compact design. [Figure 6] This is a diagram showing an example of a ferrule. [Figure 7] This is a schematic diagram showing the suturing cycle. [Figure 8] This is a schematic diagram showing the suturing cycle. [Figure 9] A diagram schematically showing a reset cycle. [Figure 10] A diagram showing an example of a flexible endoscope. [Figure 11] A diagram showing an example of a robotic endoscope (e.g., a gastric endoscope or a colon endoscope). [Figure 12A] A diagram showing an example of an instrument driving mechanism (IDM) that provides a mechanical interface to the handle portion of a robotic endoscope. [Figure 12B] A diagram showing an example of an instrument driving mechanism (IDM) that provides a mechanical interface to the handle portion of a robotic endoscope. [Figure 13] A diagram showing an example of the distal tip of an endoscope. [Figure 14] A diagram showing an example of an end effector that is controlled to perform a suturing operation.

Best Mode for Carrying Out the Invention

[0019] Although various embodiments of the present invention are shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions may occur to those skilled in the art without departing from the present invention. It will be understood that various alternative forms of the embodiments of the present invention described herein may be employed.

[0020] The embodiments disclosed herein can be combined in one or more of many ways to provide improved diagnosis and therapy to patients. The disclosed embodiments can provide improved treatments in combination with existing methods and devices, such as, for example, in combination with known methods of lung diagnosis, surgery, and surgery of tissues and organs. It should be understood that any one or more of the structures and processes described herein can be combined with any one or more additional structures and processes of the methods and devices described herein, and that the embodiments are explained by the drawings and supplementary text.

[0021] The exemplary embodiments primarily concern suturing devices or systems for colonoscopy or gastroscopy, but those skilled in the art will understand that, without limitation, the devices described herein may be used for other therapeutic or diagnostic procedures and in various anatomical regions of the patient's body. The suturing devices or systems provided may be used in urology, gynecology, rhinology, otology, laryngoscopy, and gastroenterology with endoscopes, combinations of devices with endoscopes and instruments, and endoscopes with positioning capabilities, and, without limitation, those skilled in the art will understand that, for other therapeutic or diagnostic procedures and in combination with various tools or instruments, the devices described herein may be used with bronchoscopes, neuroendoscopy, encephaloscopes, ophthalmoscopes, otoscopes, nasaloscopes, laryngoscopy, gastroscopy, esophagoscopes, bronchoscopes, thoracoscopes, pleuroscopes, angioscopes, mediastinoscopy It will be understood that these endoscopes, in various forms such as nephroscopes, gastroscopy, duodenoscopy, cholangioscopy, cholangioscopy, laparoscopy, amnioscopy, ureteroscopes, hysteroscopes, cystoscopes, rectoscopes, colonoscopes, arthroscopes, salivary gland endoscopes, orthopedic endoscopes, and other anatomical areas of the patient's body, including the brain, heart, lungs, intestines, eyes, skin, kidneys, liver, pancreas, stomach, uterus, ovaries, testes, bladder, ears, nose, mouth, bone marrow, adipose tissue, muscle, glandular tissue and mucosal tissue, spinal cord tissue and nerve tissue, hard tissues such as cartilage, teeth and bone, as well as body lumens and passages such as sinuses, ureters, colon, esophagus, pulmonary passages, blood vessels, throat, and various other structures.

[0022] The systems and devices described herein can be combined in one or more ways to provide improved diagnosis and therapy to patients. The systems and devices provided herein, when combined with existing methods and devices, can provide, for example, improved diagnosis and surgical procedures on various tissues and organs. It should be understood that one or more of the structures and processes described herein can be combined with one or more additional structures and processes of the methods and devices described herein, and that embodiments are provided by the drawings and supplementary texts.

[0023] Whenever the terms “at least,” “greater than,” or “greater than or equal to” precede the first number in a sequence of two or more numbers, those terms apply to each number in that sequence. For example, 1, 2, or 3 or more is equivalent to 1 or more, 2 or more, or 3 or more.

[0024] Whenever the terms "not greater than," "less than," or "less than or equal to" precede the first number in a sequence of two or more numbers, those terms apply to each number in that sequence. For example, 3, 2, or 1 or less is equivalent to 3 or less, 2 or less, or 1 or less.

[0025] As used herein, the terms distal and proximal may generally refer to locations relative to the device and may be opposite to anatomical locations. For example, the distal location of the primary shaft or primary catheter may correspond to the proximal location of the patient's elongated member, and the proximal location of the primary sheath or primary catheter may correspond to the distal location of the patient's elongated member.

[0026] suture instrument Figure 1 schematically shows an example of a suturing instrument 100. The suturing instrument 100 may include an end effector 101 located at the distal end of an elongated member. The elongated member may be a jointed flexible member comprising a bend 103, a flexible shaft 105, and a proximal end 107. The proximal end 107 may be a handle that is releasably attached to a robotic support. In some cases, the proximal end 107 may include a drive component (e.g., a pulley) that is releasably connected to an instrument drive mechanism to drive the operation of the end effector (e.g., needle motion, rolling motion, etc.) and / or the movement of the bend 103 (e.g., joint).

[0027] In some cases, the proximal end 107 may include a mechanical interface that allows the suturing instrument to be releasably coupled to an instrument drive mechanism mounted on a robotic support or a handheld controller. The instrument drive mechanism (IDM) may be the same as IDM1231, IDM1233 shown in Figures 12A and 12B. The IDM may include a pair of motors 1235 that actuate to rotationally drive a pair of tension wires of an elongated member. The proximal end 107 may be mounted on the instrument drive mechanism 1231 or instrument drive mechanism 1233 so that the pulley / capstan assembly is driven by the pair of motors. The number of pulleys may vary based on the configuration of the tension wires. In some cases, one, two, three, four, or more tension wires may be used to articulate the flexible suturing instrument and to drive the movement of the needle end effector. In some cases, one tension wire may be coupled to a pulley and driven by the pulley. In some cases, two or more wires may be coupled to driven pulleys. For example, two or more wires may be anti-antagonistically connected to the same driven pulley to drive the motion of a needle end effector, so that the rotation of the pulley causes tension to be applied to one wire while one wire becomes slack.

[0028] The flexed section 103 may articulate with two or more degrees of freedom. The articulation of the flexed section 103 may be controlled by applying force to the distal end via one or more tension wires. The distal ends of one or more tension wires may be attached to the distal end of the suturing device 100. In the case of multiple tension wires, pulling one wire at a time may change the orientation of the end effector 101, pitching it upward, downward, leftward, rightward, or in any direction required. In some cases, the tension wires may be anchored to the distal end of the suturing device 100, pass through the flexed section, and enter the proximal end where the tension wires are connected to a drive component (e.g., a pulley). This pulley may interact with an output shaft from a robotic system. In some cases, one or more tension wires may be used as a needle drive mechanism (e.g., the needle retraction cable and needle insertion cable in Figure 2) to drive the forward and backward movement of the needle in the end effector.

[0029] In some embodiments, the proximal end or portion of one or more tension wires may be operably connected to various mechanisms at the proximal end (e.g., gears, pulleys, capstans, etc.). The tension wire may be a metal wire, metal cable, or metal thread, or a polymer wire, polymer cable, or polymer thread. The tension wire may also be made from natural or organic material or fiber. The tension wire may be any suitable type of wire, cable, or thread capable of supporting various types of loads without deformation, significant deformation, or breakage. The distal end / portion of one or more tension wires may be anchored to or integrated with the distal portion of the suture device 100, so that the operation of the tension wire by the control unit applies force or tension to the distal portion, thereby steering or articulating at least the distal portion (e.g., the flexible portion) of the suture device (e.g., upward, downward, pitch, yaw, or any intermediate direction). The tensile wire may be made from any suitable material such as stainless steel (e.g., SS316), metal, alloy, polymer, nylon, or biocompatible material. In some embodiments, each tensile wire may be made from a different material to give them different load-bearing capacities.

[0030] The end effector 101 may include a needle device. The needle device may be attached to the distal end of the suturing instrument 100. The needle device may have two (e.g., roll and translation), three (e.g., roll and joint), four (e.g., roll, joint, and translation), or more degrees of freedom. For example, the needle device may have a roll motion (e.g., rotatable about the longitudinal axis of the elongated member) articulated around two axes (e.g., via the joint of the flexure), and a translation motion (e.g., insertion and retraction of the device). In some cases, the roll motion of the needle device may be realized via a wrist portion at the distal end of the suturing instrument, so that the needle device 101 may have a roll motion relative to the elongated member. Alternatively, the needle device may be integrated with or fixedly connected to the distal end of the flexure 103 and may not have a roll motion relative to the flexure. In some cases, the roll motion of the needle device may be realized via the roll motion of the elongated member, the wrist portion located at the distal end of the flexure 103, or a combination of both. Figure 14 shows an example of an end effector controlled to perform a suturing operation.

[0031] This disclosure provides a novel needle device or needle end effector that is smaller in size and has improved operational control, which can be used with an endoscope or colonoscope to perform suturing-related operations such as needle introduction and retrieval, and needle ejection, during upper and lower gastrointestinal (GI) tract endoscopy, gastroscopy, small bowel endoscopy, or other procedures. By reducing the size of the end effector, insertion, manipulation, and withdrawal of the endoscope during colonoscopy can be advantageously facilitated. In particular, the device and method of this disclosure provides an improved needle device with a novel and unique needle rotation cycle that enables precise needle manipulation control for robotic intraluminal surgical platforms.

[0032] Current needle devices may implement a sewing cycle that includes the needle traversing, picking up the ferrule, returning the ferrule to its ferrule compartment, and stripping the ferrule. Existing needle devices may rotate the needle at various angles so that the needle tip engages with and disengages from the ferrule. For example, by orienting the facet edge of the needle, the facet edge may engage with and disengage from the ferrule latch. However, existing needle devices may have continuous rotation or rotational motion (e.g., a rotating cam with a slot that engages with a rod), which can be difficult to manufacture (e.g., the manufacturing cost of a rotating cam is high) and may not be compact in size. It is desirable to provide an improved mechanism for engaging and disengaging the needle and ferrule that is dimensionally reduced, easy to manufacture, and suitable for automated robotic control.

[0033] The needle instruments of this disclosure may provide an improved mechanism for driving a needle rotation cycle. In some embodiments, the needle may rotate back and forth at a predetermined angle within a suturing cycle. Unlike existing methods of continuously rotating the needle in one direction, the needle instruments provided may provide a toggle-based rotation indexing mechanism to change the rotation of the needle in alternating cycles of the instrument, thereby providing precise indexing control of the operation.

[0034] In some embodiments, the needle motion of an automated robot may include a suturing cycle and a reset cycle. In some cases, a complete suturing cycle may include alternating cycles that include a suturing cycle and a reset cycle. The needle motion may alternately repeat suturing cycles and reset cycles to perform a suture. During a suturing cycle, the needle may advance or extend from an initial position, penetrate the tissue, dock with the ferrule, and then retract, pulling the suture through the tissue. During a reset cycle, the needle may advance or extend to position the ferrule back into the pocket, and then retract, leaving the ferrule in the pocket.

[0035] The orientation of the needle may be changed in alternating cycles. In some embodiments, the needle may rotate back and forth (e.g., clockwise and counterclockwise) around a longitudinal axis between suturing cycles and reset cycles. For example, in a first suturing cycle, the needle may initially be oriented towards the dock during the suturing cycle and rotated towards the strip during the reset cycle. At the end of the reset cycle, the needle rotates back to its initial orientation (dock orientation) (i.e., in the opposite direction) to prepare it for the subsequent suturing cycle (i.e., a second suturing cycle).

[0036] As described above, the ferrule can be docked and stripped by rotating the needle to two different positions in alternating cycles (suturing cycle and reset cycle). Figures 7 and 8 schematically illustrate the suturing cycle. In the initial state 700, the ferrule 701 is positioned in the pocket 702 at the distal end of the tissue opening 704, in preparation for the next suture pass. In the initial state, the ferrule 701 is separated from the needle 709. The ferrule may be secured in the pocket by a retaining spring 703 that captures the proximal end of the ferrule (to prevent the ferrule from retracting) and a shoulder 705 that captures the taper of the ferrule (the tapered surface 605 in Figure 6 to prevent the ferrule from extending distally). Note that the shoulder 705 may be formed at any location along the length (longitudinal axis) of the ferrule, such as the distal surface. The shoulder surface may or may not be a tapered surface. In some cases, the shoulder surface may be parallel to the end face of the ferrule. In the initial state, the needle 709 may be oriented in an initial orientation such that the facets or flat surface 707 of the needle rotate by a predetermined angle to a first side (e.g., to the right). The initial orientation may also be the docking orientation.

[0037] Next, during penetration and docking 710, the needle 709 may extend or advance toward its distal end, penetrating the tissue 711 captured at the tissue opening. The tip of the needle may dock in a ferrule and be held by a snap-in retaining mechanism (e.g., a valve / wedge-type click) 713. The outer surface of the needle may compress a retaining spring 703. During the extended state, the orientation of the needle may remain the same as its initial orientation, i.e., the docking orientation. The total length of the translational motion of the needle may depend on the width of the opening 704 and / or the length of the toggle plate, as will be discussed later in this specification.

[0038] Next, the needle may retract, pulling the suture 803 through the tissue 801. The needle may retract with the engaged ferrule, with one end connected to the suture 803. While retracted 800, the needle may rotate toward the strip direction, traversing back to the proximal end of the tissue opening. The needle may rotate in a direction such that the flat surface of the needle rotates toward the strip direction (e.g., downward). Once the needle has fully retracted to the proximal end 810, the needle may be oriented toward the strip direction. The user may operate the needle device to remove it from the tissue in preparation for a reset cycle.

[0039] Figure 9 schematically illustrates the reset cycle. During the reset cycle, the needle may extend distally or advance (900) to return the ferrule to the pocket and position it. The needle may maintain its strip orientation during the extended state 900 such that the flat surface 707 of the needle faces the retaining spring 901. Once the ferrule is returned to the pocket and positioned, the flat surface 707 allows the retaining spring 703 to extend and capture the ferrule. During the subsequent retracted state 910, the orientation of the needle may rotate toward the docking orientation, traversing and returning to the proximal end of the tissue opening. The needle may rotate in the opposite direction such that the flat surface of the needle rotates toward the same docking orientation (e.g., to the right) as in the initial state.

[0040] In some embodiments, the needle instrument may include a toggle-based rotating index mechanism. In some cases, the toggle-based rotating index mechanism may include a spring-biased toggle and a channel plate that rotates the needle to either a dock index or a strip index. The terms dock / strip index may be used interchangeably throughout the specification to refer to the docking and stripping orientations.

[0041] Figure 2 shows an example of an end effector 200 employing a toggle-based rotation index mechanism. The end effector can be the same as the end effector 101 shown in Figure 1. For example, the end effector 200 may include a needle device and be located at the distal end of a flexible suture device. The needle 212 may be driven forward and backward by an antagonist cable. In this specification, an antagonist cable may refer to a cable in which pulling one end of the cable causes the needle to advance and pulling the other end of the cable causes the needle to retract. For example, the needle 212 may be driven forward by a needle insertion cable 219 to pass through a tissue opening 205 (e.g., through tissue) and then driven backward by a needle retraction cable 211 (e.g., to pull a suture through the resulting hole). The antagonist cable may advantageously enable the end effector to be suitable for use with a flexible articulated shaft. The needle drive mechanism may include a cable direction change pulley 209 to achieve translational motion of the needle. Such a simple needle motion advantageously enables reduced time and reduced dexterity, making it suitable for robotic intraluminal platforms. Details of the needle drive mechanism will be explained with reference to Figures 3 and 4.

[0042] As described above, the needle may be driven forward and advanced into the suture ferrule 201. The suture ferrule may be the same as the ferrules described elsewhere in this specification. The suture ferrule 201 may be attached to the suture thread 203 at its distal end. The suture ferrule 201 may be secured in the pocket at its distal end by a retaining spring 207. The retaining spring 207 may be the same as the retaining springs shown in Figures 7 to 9.

[0043] Figure 6 shows an example of a ferrule 201. In some embodiments, the ferrule 201 may comprise a substantially tubular body having a suture engagement opening 603 and a needle engagement opening 601. In some cases, the suture engagement opening 603 may have a smaller dimension (e.g., diameter) than the needle engagement opening 601. During manufacturing, the suture (e.g., suture 203) may be inserted into the suture opening of the ferrule and swaged in position to connect the ferrule to the suture. In some cases, the suture opening may have an external shape such as a tapered surface 605 to assist the ferrule in returning to the tip of the end effector and to prevent the ferrule from advancing further when the ferrule is returned to the pocket.

[0044] The needle engagement opening 601 may include a local wall deformation 611 or tab 606 that can be deformed inward to reduce the effective diameter of the needle engagement opening. For example, the local wall deformation 611 may be a crimped depression. In some cases, the tab or local wall deformation may be integrally formed with the ferrule during manufacturing. Such deformation may allow the ferrule to engage with the needle 610 during the operation of the device and prevent separation under the force supplied by the tissue. The needle engagement opening may have a molded inner surface having a suitable size and shape 608, 609 at the proximal opening to facilitate docking with the needle tip. Such a needle engagement opening may also allow the needle to taper sufficiently for tissue expansion while ensuring that the distance between the outermost ferrule diameter and the needle diameter is as small as possible to prevent disengagement with the ferrule during transverse.

[0045] The ferrule may be separated from the needle by a stripping mechanism at the distal end of the end effector so that the ferrule is returned to the pocket at the tip of the end effector. The stripping mechanism may include a retaining spring 207 in Figure 2. Referring again to Figure 2, the end effector may include a toggle-based rotating indexing mechanism. The indexing mechanism may include a toggle mechanism comprising a toggle 213, a toggle spring 217, a toggle pivot 215, and a toggle plate 221 for switching the needle position via a needle flag.

[0046] Figures 3 and 4A show examples of a needle drive mechanism 300 and an indexing mechanism 400. As shown in Figure 3, the needle drive mechanism may include cables 211 and 219, as well as a reversing pulley 209 for translating the needle forward and backward. In some cases, the needle 212 may be attached to the needle retraction cable 211 via a needle flag 301 and a cable crimp 303. The needle flag 301 may be fixedly attached to the needle by welding together, or by integrally forming it by machining, MIM, overmolding, or other manufacturing methods. The needle flag 301 may be fixedly connected to the cable crimp 303 by welding together, etc. Such a connection mechanism advantageously allows for tension and deflection from the centerline of the retraction cable 211, thereby providing a centering force that biases the needle rotation to an intermediate position. Alternatively, the needle flag may be directly connected to the cable without a cable crimp.

[0047] The rotation of the needle is controlled by a toggle 213 and a toggle plate 221 that interact with the needle flag 301. As shown in Figures 4A and 4B, as the needle extends (moves forward) and retracts (moves backward), the tail of the needle flag 301 is positioned in a track or channel of the toggle plate and moves into different channels of the toggle plate 221 that rotate the needle either dock-oriented or strip-oriented. The toggle plate 221 may have a substantially flat surface, and the channels are formed on a substantially flat surface.

[0048] As shown in Figure 4B, when the needle reaches a fully retracted position in each cycle (e.g., the proximal end of the toggle plate), the needle flag 301 switches the toggle position, thereby rotating the needle to the opposite position for the next cycle. The toggle 213 may be a bistable spring load mechanism, and a leaf spring 217 proximal to the toggle may resist the toggle rotation from one state to the other. When the needle flag 301 reaches the proximal end and compresses the toggle 213, the force from the needle flag, provided by the retraction cable, acts on the toggle, allowing it to overcome the "overcenter" resistance from the spring and move to the other state (e.g., switching from the inclined channel 403 / 407 to either the strip channel 405 or the dock channel 401 parallel to the axial axis).

[0049] In the illustrated example, the toggle plate may have multiple channels. The multiple channels may include a first channel for stripping and a second channel for docking, where the needle orientation remains constant. The multiple channels may further include a third channel for toggling, where the needle orientation varies between the stripping position and the docking position. The toggle channel may have two inlets and two outlets, the outlets being gate-controlled by the toggle, while the channel remains the same. For example, as shown in Figure 4B, when the needle is in an initial state, i.e., "position 1" (corresponding to initial state 700 shown in Figure 7), the toggle may be pushed to the right from the center position. When the needle is driven forward (corresponding to the through and docking state 710 shown in Figure 7), the tail of the needle flag moves along the first channel 401 toward the docking position (along a forward path or substantially linear channel 401), and the needle orientation is maintained in the docking direction while the needle flag moves along the first channel 401 (path 1). As the needle retracts towards the proximal end (along path 2), the needle flag may move along the toggle plate channel 403 (inclined channel) in path 2 and reach a fully retracted position (position 4), and the toggle may be pushed in the opposite direction (e.g., to the left), and the orientation of the needle is changed to strip orientation while the needle moves along the second channel 403. As the needle advances in a reset cycle, the needle flag may move towards the strip position along the toggle plate channel 405 (along path 4) while maintaining the needle in strip orientation. As the needle retracts in a reset cycle (along path 5), the needle flag may move along the toggle plate channel 403 and retract back to its initial position.

[0050] In some cases, the forward and backward rotation of the needle may exceed an angle of approximately 60 degrees between alternating cycles. Alternatively, the range of rotation may be any number less than 60 degrees or greater than 60 degrees. The range of rotation angles may depend on the dimensions or shape of the flat surface of the needle that engages with and disengages from the ferrule.

[0051] The unique toggle-base rotation mechanism can advantageously enable a more compact and smaller needle end-effector design. Conventional needle devices may utilize a rotating cam to orient the needle facets. For example, when the cam needle fully retracts and rotates 180°, the opposite side of the shoulder is oriented toward the ferrule lath. However, such orientation changes are continuously unidirectional (clockwise or counterclockwise), and such cam mechanisms can increase the diameter and length of the needle end-effector. The increased dimensions of the needle end-effector can increase the minimum curvature required for operation within meandering body passages. The toggle-base rotation mechanism of this disclosure advantageously enables a more compact needle end-effector design. The reduced dimensions of the end-effector (e.g., diameter) can improve anatomical access and allow for use in conjunction with additional tissue manipulation instruments (e.g., grippers) for tissue placement and suture management. Furthermore, when the intraluminal device with the provided end effector is used in conjunction with a robotic surgical platform, the overall diameter can be reduced, which enables higher quality and faster lesion closure than existing techniques.

[0052] Figures 5A and 5B show examples of needle end effector dimensions. For example, the outer diameter 511 of the instrument may be 5 mm, 4.9 mm, 4.8 mm, 4.7 mm, 4.6 mm, 4.5 mm, 4.4 mm, 4.3 mm, 4.2 mm, 4.1 mm, 4 mm, 3.5 mm, 3 mm or less, any number between the above, or a number greater than 5 mm or less than 3 mm. The total length 501 of the needle end effector may be 30 mm, 29 mm, 28 mm, 27 mm, 26 mm, 25 mm, 24 mm, 23 mm, 22 mm, 21 mm, 20 mm, 19 mm, 18 mm, 17 mm, 16 mm, 15 mm or less, any number between the above, or a number greater than 30 mm or less than 15 mm. In some cases, the overall size of the needle end effector, e.g., the total length and diameter, may substantially depend on the size of the tissue opening (e.g., the length 502 and depth 503 of the tissue opening). The length 504 of the tip of the end effector may substantially depend on the length of the ferrule (e.g., the sum of the lengths of the needle opening 607 and the suture opening).

[0053] The toggle mechanism 500 may comprise a toggle 213, a toggle spring 217, a toggle pivot 215, and a toggle plate 221. As described above, the toggle mechanism may switch the position of the needle by interacting with the needle flag. The toggle mechanism 500 may be a substantially planar plate with slots formed therein that engage with the needle flag. The slots are formed on a substantially flat surface of the planar plate. The slots may guide the needle flag at various angles when the needle flag travels along different paths. Different paths may be formed by slots oriented obliquely with respect to the axial axis (i.e., the longitudinal direction) and slots substantially parallel to the axial axis. In some cases, the different paths may include a path substantially parallel to the axial axis when the needle is driven forward and an obliquely oriented path when the needle is driven backward.

[0054] As shown in the example, the slot may have dimensions that allow for smooth traverse of the needle flag. In some cases, considering that the needle flag may be oriented along the slot at different angles, the width of the slot may vary in location. For example, width 516 may be smaller than widths 515, 519, or 517. Slots oriented at an angle may be formed by angular island mechanisms 512, 513, 514, and 518 that guide the needle flag along different paths. The toggle may have a shape that allows it to rotate to an off-center angle 512. As described above, the rotation mechanism of the toggle base allows the needle to rotate back and forth over a predetermined angular range, such as a range of about 60 degrees between alternating cycles. Alternatively, the rotation range may be any number less than 60 degrees or greater than 60 degrees.

[0055] The toggle mechanism can be formed from any suitable material. For example, the toggle plate, toggle, etc., may be made of stainless steel or other hard material. By forming tracks or slots on a substantially planar surface, the manufacturing process can be simplified, thereby reducing costs.

[0056] Flexible endoscope The provided suturing instrument may be utilized by any robotic intraluminal system or platform. In one aspect of the present invention, the suturing instrument may be inserted through the working channel of a flexible endoscope to perform the suturing operation described above. The suturing instrument may be maneuverable independently of the endoscope. For example, the suturing instrument shaft may advance, retract, and rotate relative to the flexible endoscope. Figure 10 shows an example of a flexible endoscope 1000 according to some embodiments of the present disclosure. As shown in Figure 10, the flexible endoscope 1000 may comprise a handle / proximal section 1009 and a flexible elongated member inserted into the interior of a target. The flexible elongated member may be the same as those described above. In some embodiments, the flexible elongated member may comprise a proximal shaft (e.g., insertion shaft 1001), a maneuverable tip (e.g., tip 1005), a maneuverable section (active bending section 1003), and a proximal shaft section 100. The endoscope 1000 may also be referred to as a maneuverable catheter assembly, as described elsewhere in this specification. In some cases, the endoscope 1000 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 varying levels of stiffness along the shaft to improve functional operation.

[0057] The endoscope or maneuverable catheter assembly 1000 may include a handle portion 1009, which may comprise one or more components configured to process image data, supply power, or establish communication with other external devices. For example, the handle portion may comprise circuits and communication elements that enable electrical communication between the maneuverable catheter assembly 1000, an instrument drive mechanism (not shown), and any other external system or device. In another example, the handle portion 1009 may comprise circuit elements such as a power supply for supplying power to the endoscope's electronics (e.g., a camera, electromagnetic sensors, and LED lights).

[0058] One or more components located on the handle may be optimized so that expensive and complex components are assigned to a robotic support system, a handheld controller, or an instrument drive mechanism, thereby reducing costs and simplifying the design of the disposable endoscope. The handle or proximal portion may be provided with electrical and mechanical interfaces to enable electrical and mechanical communication with the instrument drive mechanism. The instrument drive mechanism may comprise a set of motors that actuate a set of tension wires of the catheter. The handle portion of the catheter assembly may be mounted on the instrument drive mechanism so that the pulley / capstan assembly is driven by a set of motors. The number of pulleys may vary based on the configuration of the tension wires. In some cases, one, two, three, four, or more tension wires may be used to articulate the flexible endoscope or flexible catheter.

[0059] The handle section may be designed to allow the robotic endoscope to be low-cost and disposable. For example, typical manual and robotic endoscopes may have a cable at the proximal end of the endoscope handle. The cable often includes illumination fibers, camera video cables, and other sensor fibers or cables such as electromagnetic (EM) sensors or shape-sensing fibers. Such complex cables can be expensive and increase the cost of the endoscope. The robotic endoscope provided may have an optimized design that allows for the adoption of simplified structures and components while maintaining mechanical and electrical functionality. In some cases, the handle section of the robotic endoscope may adopt a cable-free design while providing a mechanical / electrical interface to the catheter.

[0060] An electrical interface (e.g., a printed circuit board) may enable image / video data and / or sensor data to be received by a communication module in the instrument drive mechanism and transmitted to other external devices / systems. In some cases, the electrical interface may establish electrical communication without cables or wires. For example, the interface may comprise pins soldered onto an electronic circuit board such as a printed circuit board (PCB). For example, a receptacle connector (e.g., a female connector) may be provided on the instrument drive mechanism as a mating interface. This may advantageously allow the endoscope to be quickly plugged into the instrument drive mechanism or robotic support without the use of extra cables. Such an electrical interface may also function as a mechanical interface so that both mechanical and electrical connections are established when the handle is plugged into the instrument drive mechanism. Alternatively, or in addition to the above, the instrument drive mechanism may provide only a mechanical interface. The handle may communicate with a modular wireless communication device or any other user device (e.g., a portable / handheld device or controller) for transmitting sensor data and / or receiving control signals.

[0061] In some cases, the handle portion 1009 may include one or more mechanical control modules, such as a Luer 1011, for interfacing with a cleaning / suction system. In some cases, the handle portion may include levers / knobs for joint control. Alternatively, joint control may be located in a separate controller attached to the handle portion via an instrument drive mechanism.

[0062] The endoscope may be mounted to a robotic support system or a handheld controller via an instrument drive mechanism. The instrument drive mechanism may be provided by either a suitable controller device (e.g., a handheld controller), which may or may not include a robotic system. The instrument drive mechanism may provide mechanical and electrical interfaces to the maneuverable catheter assembly 1000. The mechanical interface may allow the maneuverable catheter assembly 1000 to be releasably connected to the instrument drive mechanism. For example, the handle portion of the maneuverable catheter assembly can be attached to the instrument drive mechanism via a quick installation / release means such as a magnet or a spring-loaded lever. In some cases, the maneuverable catheter assembly may be manually connected to or disconnected from the instrument drive mechanism without the use of tools. Further details regarding the instrument drive mechanism will be provided below.

[0063] In the illustrated example, the distal end of the catheter or endoscope shaft is configured to articulate / flex with two or more degrees of freedom to provide a desired camera view or control the direction of the endoscope. As shown in the example, an imaging device (e.g., camera) and a position sensor (e.g., electromagnetic sensor) 1007 are located at the tip 1005 of the catheter or endoscope shaft. For example, the camera's line of sight may be controlled by controlling the articulation of the active flex portion 1003. In some cases, the camera angle may be adjustable so that the line of sight can be adjusted without or in addition to articulating the distal end of the catheter or endoscope shaft. For example, the camera may be oriented at a certain angle (e.g., tilt) with respect to the axial direction of the endoscope tip using optical components.

[0064] The distal tip 1005 may be a rigid component that allows for the integration of positioning sensors, such as an imaging device (e.g., a camera) and other electronic components (e.g., an LED light source), at the distal tip. Depending on the type of endoscope, the distal tip may also include other sensors, such as an electromagnetic (EM) sensor or an inertial measurement unit.

[0065] Robotic endoscopes may or may not have real-time EM tracking capabilities. When a robotic endoscope is integrated with an EM sensor, the EM sensor, comprising one or more sensor coils integrated at one or more locations and orientations on the medical instrument (e.g., the tip of the endoscopic instrument), measures fluctuations in the EM field generated by one or more static EM field generators positioned close to the patient. The location information detected by the EM sensor is stored as EM data. The EM field generator (or transmitter) may be positioned close to the patient to generate a low-intensity magnetic field that the integrated sensor can detect. The magnetic field induces a small current in the sensor coil of the EM sensor, which can be analyzed to determine the distance and angle between the EM sensor and the EM field generator. For example, the EM field generator may be positioned close to the patient during the procedure to position the EM sensor in 3D space, or position and orientation of the EM sensor in 5D or 6D space. This may provide the operator with visual guidance when driving the endoscope toward the target site.

[0066] The endoscope may have a design specific to elongated members. In some cases, the active bending section 1003 and proximal shaft 1001 of the endoscope may consist of a single tube incorporating a series of notches (e.g., reliefs, slits, etc.) along its length, which may allow for improved flexibility, desired rigidity, and a mechanism to prevent deviation (e.g., a mechanism to define a minimum bending radius).

[0067] As described above, the active flexing section 1003 may be designed to allow flexion (e.g., joints) in two or more degrees of freedom. Larger degrees of flexion, such as 180 degrees and 270 degrees (or other joint parameters for clinical symptoms), can be achieved by the specific structure of the active flexing section. In some cases, the active flexing section and / or the passive section may be manufactured separately as modular components and assembled to the proximal shaft. In some cases, the notch patterns of the active flexing section and the passive section may differ such that at least the minimum flexion radii of the two sections are different. In some cases, a variable minimum flexion radius along the axial axis of the elongated member may be provided such that the active flexing section or the passive section may include two or more different minimum flexion radii.

[0068] The joints of the endoscope may be controlled by applying force to the distal end of the endoscope via one or more tension wires. One or more tension wires may be attached to the distal end of the endoscope. In the case of multiple tension wires, pulling one wire at a time may change the orientation of the distal tip, pitching it upward, downward, left, right, or in any direction required. In some cases, the tension wires may be anchored to the distal tip of the endoscope, pass through a bend, and enter a handle to which the tension wires are connected to a drive component (e.g., a pulley). This handle pulley may interact with an output shaft from a robotic system.

[0069] In some embodiments, the proximal end or portion of one or more tension wires may be operably connected to various mechanisms (e.g., gears, pulleys, capstans, etc.) in the handle portion of the catheter assembly. The tension wire may be a metal wire, metal cable, or metal thread, or a polymer wire, polymer cable, or polymer thread. The tension wire may also be made from natural or organic material or fiber. The tension wire may be any suitable type of wire, cable, or thread capable of supporting various types of loads without deformation, significant deformation, or breakage. The distal end / portion of one or more tension wires may be anchored to or integrated with the distal portion of the catheter, and as a result, the operation of the tension wire by the control unit may apply force or tension to the distal portion, thereby maneuvering or articulating at least the distal portion (e.g., the flexible portion) of the catheter (e.g., upward, downward, pitch, yaw, or any intermediate direction).

[0070] The tension wire may be made from any suitable material such as stainless steel (e.g., SS316), metal, alloy, polymer, nylon, or biocompatible material. The tension wire may be a wire, cable, or thread. In some embodiments, each tension wire may be made from a different material to give it different load-bearing capacity. In some embodiments, each section of the tension wire may be made from a different material to give it different stiffness and / or load-bearing capacity along the tension. In some embodiments, the tension wire may be used for transmitting electrical signals.

[0071] Proximal design can improve the reliability of the device without introducing extra costs, enabling low-cost, single-use endoscopes. In another aspect of the present invention, a single-use robotic endoscope is provided. The robotic endoscope may be a gastroscopy and may be the same as the maneuverable catheter assembly described elsewhere in this specification. Conventional endoscopes can be complex in design and are typically designed for reuse after a procedure, requiring thorough cleaning, disinfection, or sterilization after each procedure. Existing endoscopes are often designed with complex structures to ensure that the endoscope can withstand cleaning, disinfection, and sterilization processes. The robotic endoscope provided may be a single-use endoscope that can advantageously reduce patient-to-patient cross-contamination and infection. In some cases, the robotic gastroscopy may be delivered to healthcare workers in a pre-sterilized package and intended to be discarded after single use.

[0072] As shown in Figure 11, the robotic endoscope (e.g., gastroscopy or colonoscope) 1110 may comprise a handle portion 1113 and a flexible elongated member 1111. In some embodiments, the flexible elongated member 1111 may comprise a shaft, a maneuverable tip, a maneuverable / active bending portion, and optionally, a passive anti-dislodgement portion. The robotic gastroscopy 1110 may be the same as the maneuverable catheter assembly shown in Figure 10. The robotic gastroscopy may be a single-use robotic endoscope. In some cases, only the catheter may be disposable. In some cases, at least a portion of the catheter may be disposable. In some cases, the entire robotic gastroscopy may be released from the instrument drive mechanism and can be discarded. In some cases, the gastroscopy may include varying levels of stiffness along its shaft to improve functional operation. In some cases, the minimum bending radius along the shaft may vary so that kink resistance or anti-dislodgement capability can be configured along the length.

[0073] The robotic gastroscopy can be releasably coupled to the instrument drive mechanism 1120. The instrument drive mechanism 1120 may be mounted on the arm of a robotic support system or on any operating support system as described elsewhere herein. The instrument drive mechanism may provide mechanical and electrical interfaces to the robotic gastroscopy 1110. The mechanical interface may allow the robotic gastroscopy 1110 to be releasably coupled to the instrument drive mechanism. For example, the handle of the robotic gastroscopy can be attached to the instrument drive mechanism via quick installation / release means such as magnets or spring-loaded levers (levels). In some cases, the robotic gastroscopy may be manually coupled to or detached from the instrument drive mechanism without the use of tools.

[0074] Figures 12A and 12B show an example of an instrument drive mechanism (IDM) 1220 that provides a mechanical interface to the handle of a robotic endoscope. In some cases, the IDM 1220 for the robotic endoscope and one or more IDMs 1231, IDM 1233 for one or more instruments (e.g., suturing instruments) may be mounted on a robotic arm 1200. As shown in the example, the instrument drive mechanism (IDM) 1220 for the robotic endoscope may include a set of motors 1221 that actuate a set of tension wires to rotate a flexible endoscope or flexible catheter. The handle of the catheter assembly may be mounted on the instrument drive mechanism 1220 so that a pulley assembly or capstan is driven by a set of motors. The number of pulleys may vary based on the configuration of the tension wires. In some cases, one, two, three, four, or more tension wires may be used to articulate the flexible endoscope or flexible catheter. Similarly, the instrument drive mechanism (IDM) 1231 for the suturing instrument according to this specification may include a set of motors 1235 that act to rotationally drive a set of tension wires of the suturing instrument, thereby controlling the joint of the bending portion of the suturing instrument, the rolling motion of the needle end effector, and the suturing operation, as described above.

[0075] The handle section may be designed to allow the robotic gastroscopy to be low-cost and disposable. For example, typical manual and robotic gastroscopy endoscopes may have a cable at the proximal end of the gastroscopy handle. The cable often includes illumination fibers, camera video cables, and other optional sensor fibers or cables such as electromagnetic (EM) sensors or shape-sensing fibers. Such complex cables can be expensive and increase the cost of the gastroscopy. The robotic gastroscopy offered may have an optimized design that allows for the adoption of simplified structures and components while maintaining mechanical and electrical functionality. In some cases, the handle section of the robotic gastroscopy may employ a cable-free design while providing a mechanical / electrical interface to the catheter.

[0076] Figure 13 shows an example of the distal tip 1300 of an endoscope. In some cases, the distal portion or distal tip 1300 of the endoscope may be substantially flexible so that it can be maneuvered in one or more directions (e.g., pitch, yaw). The endoscope may comprise a tip, a bend, and an insertion shaft. In some embodiments, the endoscope may have variable flexural stiffness along the longitudinal axis. For example, the endoscope may comprise multiple sections having different flexural stiffnesses (e.g., flexible, semi-rigid, and rigid). Flexural stiffness may be varied by selecting materials with different stiffness / rigidity, varying the structure (e.g., notches, patterns) in different segments, adding additional support components, or any combination of the above. In some embodiments, the endoscope may have a variable minimum bending radius along the longitudinal axis. By selecting different minimum bending radii at different locations along the endoscope, deviation prevention capability may be advantageously provided while still allowing the endoscope to reach hard-to-reach areas. In some cases, it may not be necessary to significantly bend the proximal end of the endoscope, and therefore, the proximal portion of the endoscope may be reinforced with additional mechanical structures (e.g., additional layers of material) to achieve higher bending stiffness. Such a design may provide support and stability to the endoscope. In some cases, variable bending stiffness may be achieved by using different materials during the extrusion of the endoscope. This may advantageously allow for different levels of stiffness along the shaft of the endoscope in the extrusion manufacturing process without the need to additionally fasten or assemble different materials.

[0077] The distal portion of the endoscope may be steered by one or more tension wires. The distal portion of the endoscope may be made of any suitable material such as copolymer, polymer, metal, or alloy so that it can be bent by the tension wires. In some embodiments, the proximal end or termination of one or more tension wires may be connected to a drive mechanism (e.g., gears, pulleys, capstan, etc.) via a mooring mechanism, as described above. The distal end or distal portion of one or more tension wires may be moored to or integrated with the distal portion of the endoscope, and as a result, the movement of the tension wires by the control unit may apply force or tension to the distal portion, thereby steering or articulating at least the distal portion (e.g., the flexible portion) of the endoscope (e.g., upward, downward, pitch, yaw, or any intermediate direction).

[0078] The endoscope may have dimensions that allow one or more electronic components to be integrated into the endoscope. For example, the outer diameter of the distal tip may be in the range of 3 mm to 25 mm, and the diameter of the instrument channel 1301 may be in the range of 2 mm to 6 mm, so that one or more instruments can be removably inserted into the surgical site through the endoscope. However, it should be noted that, depending on the application, the outer diameter may be in the range of either less than 3 mm or greater than 25 mm, and the diameter of the instrument channel 1301 may be in the range of either about 4 mm or 5 mm, etc., so that the suturing instruments of this specification can pass through. Space not occupied by fluid or passing instruments can be used to incorporate electronic components into the wall of the endoscope.

[0079] One or more electronic components may comprise an imaging device, an illumination device, or other optionally selected sensors. In some embodiments, the imaging device may be a video camera 1313. The imaging device may comprise an optical element and an image sensor for capturing image data. The image sensor may be configured to generate image data in response to the wavelength of light. Various image sensors may be used for capturing image data, such as complementary metal oxide semiconductors (CMOS) and charge-coupled devices (CCDs). The imaging device may be a low-cost camera. In some cases, the image sensor may be mounted on a circuit board. The circuit board may be an imaging printed circuit board (PCB). The PCB may comprise a plurality of electronic elements for processing image signals. For example, a circuit for a CCD sensor may comprise an A / D converter and an amplifier for amplifying and converting the analog signal provided by the CCD sensor. Optionally, the image sensor may be integrated with the amplifier and the converter for converting the analog signal to a digital signal, so that a circuit board may not be required. In some cases, the output of the image sensor or circuit board may be image data (digital signals) that can be further processed by the camera circuit or camera processor. In some cases, the image sensor may include an array of optical sensors.

[0080] The lighting device may include one or more light sources 1311 located at the distal tip. The light sources may be light-emitting diodes (LEDs), organic light-emitting diodes (OLEDs), quantum dots, or any other suitable light sources. In some cases, the light sources may be miniature LEDs or dual-tone flash LED lighting to make the design more compact.

[0081] The imaging and illumination devices may be integrated with the endoscope. For example, the distal end of the endoscope may have a suitable structure that accommodates at least the dimensions of the imaging and illumination devices. The imaging and illumination devices may be incorporated into the catheter. The camera may be located in the distal end 1300. The distal tip may have a structure that receives the camera and illumination devices. For example, the camera may be incorporated into a cavity at the distal tip of the catheter. The cavity 1410 may be integrally formed with the distal end of the cavity and may have dimensions that accommodate the length / width of the camera so that the camera cannot move relative to the endoscope. The camera may be adjacent to one or more instrument channels 1301 of the endoscope to provide a near view of tissue or organ. In some cases, the posture or orientation of the imaging device may be controlled by controlling the rotational movement (e.g., roll) of the endoscope.

[0082] Power to the camera may be supplied by a wired cable. In some cases, the cable wire may be in a bundle of wires that supplies power to the camera and to the illumination element or other circuitry at the distal tip of the endoscope. The camera and / or light source may be powered from a power source located in the handle via wire, copper wire, or any other suitable means that runs along the length of the catheter. In some cases, real-time images or videos of tissue or organs may be transmitted to an external user interface or displayed wirelessly. Wireless communication may be WiFi, Bluetooth®, RF communication, or other forms of communication. In some cases, images or videos captured by the camera may be broadcast to multiple devices or systems. In some cases, image and / or video data from the camera may be transmitted downward along the length of the catheter to a processor located in the handle via wire, copper wire, or any other suitable means. Image or video data may be transmitted to an external device / system via wireless communication components in the handle. In some cases, the system may be designed so that the wires are not visible or exposed to the operator.

[0083] In conventional endoscopy, illumination may be provided by a fiber optic cable that transmits light from a light source located at the proximal end of the endoscope to the distal end of the robotic endoscope. In some embodiments of this disclosure, to reduce design complexity, a small LED light may be employed and incorporated into the distal end of the catheter. In some cases, the distal end may have a structure having dimensions to accommodate the dimensions of the small LED light source. As shown in the illustrated example, two cavities may be integrally formed with the endoscope to receive two LED light sources 1311. For example, the outer diameter of the distal tip may be in the range of 3 mm to 25 mm, and the diameter of the working channel of the endoscope may be about 4.5 or 6 mm, so that two LED light sources can be incorporated into the distal end. The outer diameter can be in the range of less than 3 mm or greater than 25 mm, and the diameter of the instrument channel 1301 can be in the range depending on the dimensions of the instrument or the specific application. Any number of light sources may be provided. The internal structure of the distal end may be designed to accommodate any number of light sources.

[0084] In some cases, each LED may be connected to a power wire that can reach the proximal handle. In some embodiments, the LEDs may be soldered to separate power wires that are later bundled together to form a single strand. In some embodiments, the LEDs may be soldered to pull the power supply wires. In other embodiments, the LEDs may be crimped or connected directly to a single pair of power wires. In some cases, a protective layer, such as a thin layer of biocompatible adhesive, may be applied to the front of the LEDs to provide protection while allowing light emission. In some cases, an additional cover may be positioned on the front end face of the distal tip to provide precise positioning of the LEDs and sufficient space for the adhesive. The cover may be made of a transparent material that matches the refractive index of the adhesive so that the illumination light is not obstructed.

[0085] Working channels (e.g., instrument channel 1301, auxiliary channels) may be designed to provide protection for internal components such as flexible instruments (e.g., suturing instruments, forceps, etc.). When flexible instruments pass through conventional working channels, they may be obstructed by the working channels due to twisting, ellipsing, and / or high frictional forces. Working channels may provide the ability to achieve high hoop strength and low bending radius. Working channels may also be designed to provide low friction on the inner surface. Suturing instruments described herein may pass through working channels to advance over the distal tip of the endoscope or retract into the working channels.

[0086] While preferred embodiments of the present invention are shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided merely as examples. Numerous variations, modifications, and substitutions will be conceivable to those skilled in the art without departing from the present invention. It will be understood that various alternative forms to the embodiments of the present invention described herein may be employed in carrying out the present invention. The following claims define the scope of the present invention, and the methods and structures within these claims, as well as their equivalents, are intended to be encompassed by the scope of the present invention.

Claims

1. A flexible shaft with a joint that allows for bending, A needle end effector located at the distal end of the articulated bending portion, comprising a rotary mechanism on a toggle base that switches the orientation of the needle so that the needle engages with and disengages from a ferrule, and A suturing instrument equipped with [a specific feature].

2. The suturing device according to claim 1, wherein the needle rotates back and forth over a predetermined angular range with respect to the axial axis so as to switch the direction.

3. The suture device according to claim 2, wherein the predetermined angle range is approximately 60°.

4. The suturing device according to claim 1, wherein the rotating mechanism of the toggle base comprises a plate having a plurality of channels formed therein that guide the switching of the orientation of the needle.

5. The suture device according to claim 4, wherein the plurality of channels are formed on a substantially flat surface of the plate.

6. The suturing device according to claim 4, wherein the rotation mechanism of the toggle base includes a spring-biased toggle that switches the needle from a channel inclined with respect to the axial axis of the needle end effector to a channel parallel to the axial axis of the needle end effector.

7. The suturing device according to claim 1, wherein the rotating mechanism of the toggle base comprises an antagonist cable that drives the forward and backward movement of the needle.

8. The suturing device according to claim 1, wherein the length of the needle end effector is 30 mm or less.

9. The suturing device according to claim 1, wherein the diameter of the needle end effector is 5 mm or less.

10. The suturing device according to claim 1, wherein the needle end effector is rotatable relative to the articulated bending portion.

11. The suturing device according to claim 1, wherein the needle end effector is fixedly connected to the articulated bending portion.

12. The suture device according to claim 1, wherein the articulated bending portion is operated by one or more tension wires, and the proximal ends of the one or more tension wires are connected to the handle of the suture device.

13. The suturing device according to claim 12, wherein a cable that drives the translational motion of the needle is connected to the handle.

14. The suturing device according to claim 12, wherein the handle is releasably connected to a robot support via a first device drive mechanism.

15. The suturing device according to claim 12, wherein the first device drive mechanism drives the joint movement of the articulated bending portion and the operation of the needle end effector.

16. The suturing instrument according to claim 1, wherein the suturing instrument is inserted through the working channel of a flexible robotic endoscope.

17. The suturing device according to claim 16, wherein the flexible robot endoscope is provided with a jointly movable bendable portion.

18. The suturing device according to claim 17, wherein the flexible robotic endoscope is releasably connected to a robotic support via a second instrument drive mechanism.

19. The suturing device according to claim 18, wherein the articulated flexible portion is operated by the second device drive mechanism.

20. A flexible shaft having a jointly movable bendable portion, wherein the joint movement of the jointly movable bendable portion is driven by one or more tension wires, A needle end effector connected to the distal end of the articulated bending portion, comprising a needle that is driven by a cable to translate and rotate, and engage and disengage with a ferrule, A handle configured to releasably connect a robotic intraluminal suturing instrument to an instrument drive mechanism, wherein the instrument drive mechanism acts on one or more tension wires and the cable, and A robotic intraluminal suturing device equipped with the following features.

21. The robotic intraluminal suturing device according to claim 20, wherein the length of the needle end effector is 30 mm or less.

22. The robotic intraluminal suturing device according to claim 20, wherein the diameter of the needle end effector is 5 mm or less.

23. The robotic intraluminal suturing device according to claim 20, wherein the needle end effector is rotatable relative to the articulated bending portion.

24. The robotic intraluminal suturing device according to claim 20, wherein the needle end effector is fixedly connected to the articulated bending portion.

25. The robotic intraluminal suturing device according to claim 20, wherein the needle rotates back and forth over a predetermined angular range with respect to an axial axis so as to switch the orientation of the needle.

26. The robotic intraluminal suturing device according to claim 25, wherein the predetermined angular range is approximately 60°.

27. The robotic intraluminal suturing device according to claim 20, wherein the needle end effector comprises a toggle base rotation mechanism for switching the direction of the needle.

28. The robotic intraluminal suturing device according to claim 27, wherein the rotation mechanism of the toggle base comprises a plate having a plurality of channels that guide the switching of the orientation of the needle.

29. The robotic intraluminal suturing device according to claim 28, wherein the plurality of channels are formed on a substantially flat surface of the plate.

30. The robotic intraluminal suturing instrument according to claim 20, wherein the robotic intraluminal suturing instrument is inserted through the working channel of a flexible robotic endoscope.

31. The robotic intraluminal suturing device according to claim 30, wherein the flexible robotic endoscope has a jointly movable bendable portion and is releasably connected to a robotic support.

Images