Systems and methods for robotic endoluminal grasping and suturing instrument

Abstract

A surgical instrument is provided. The surgical instrument comprises: a flexible shaft comprising an articulatable bending section; and an end effector comprising a pair of jaws located at a distal end of the bending section. The end effector is switchable between a grasper mode and a suturing mode at least by changing a close angle limit of the pair of jaws.

Description

SYSTEMS AND METHODS FOR ROBOTIC ENDOLUMINAL GRASPING ANDSUTURING INSTRUMENTCROSS-REFERENCE

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 661,207, filed on June 18, 2024, which is entirely incorporated herein by reference.BACKGROUND

[0002] Endoscopy procedures use an endoscope to examine the interior of a hollow organ or cavity of the body. Unlike many other medical imaging techniques, endoscopes are inserted into the organ directly via the mouth or other naturally occurring orifices. Flexible endoscopes that can deliver instinctive steering and control are useful in diagnosing and treating diseases that are accessible through any natural orifice in the body. Depending on the clinical indication, the endoscope may be designated as colonoscope, gastroscope, bronchoscope, ureteroscope, ENT scope, and various others. For example, a flexible colonoscope may be intubated to transverse colon for diagnosis and / or surgical treatment.

[0003] An endoscope device may have a working channel allowing tools such as graspers, cutters or suturing instruments to pass through. In another example, a suturing device can be coupled to the distal end of an endoscope, which enables suturing in the gastroesophageal tract of a patient. Suturing in the colon is more challenging due to the lateral space constraints and the tortuosity of the colon which require tools to have flexible shafts. For instance, soft tissue suturing is typically performed by utilizing a free needle and a needle driver. Current solutions may include purpose-built suturing devices with built-in needle to streamline the suturing workflow and eliminate issues related to positioning and gripping a free needle in the jaws of the suturing devices. However, such purpose-built devices have limitations including aperture size and depth which limit their ability to close a full-thickness wound. For example, current suturing instrument is a 10 mm outer diameter (OD) device with a 9 mm length needle. The needle is installed with the end effector prior to inserting the instrument through the trocar and to the surgical site. The needle remains coupled to the end effector throughout the procedure resulting in the instrument can only be used as a suturing tool.

[0004] Additionally, current instrument may not be suitable for endoluminal suturing applications due to the rigid components involved in the instrument. For instance, position and orientation of the current instrument are driven manually by a clinician where the instrument shaft has to be rigid in order to create a fulcrum with the trocar. The instrument typically includes a rigid component (e.g., securing blade) that runs the full length of the shaft from the distal endof the instrument to the proximal end in order for the clinician to operate the needle. The large diameter of the suturing instrument and the rigid component limits the current suturing instrument from being suitable for endoluminal suturing applications. For example, the large diameter of the current instrument requires a working channel of the endoscope with increased diameter to in order for the instrument to pass through. Additionally, the large diameter of the end effector can occlude the view of the tissue being manipulated. The movement of the instrument can be further limited by the rigid component, for instance, the flat wire prevents the shaft from being flexible in at least one plane (e.g., the plane orthogonal to the width of the blade / flat wire). The rigid component for operating the needle such as the flat wire or securing blade can allow for bending along the thickness of the wire, but not articulation of the end effector in a plane orthogonal to the width of the blade / flat wire. For at least the aforementioned reasons, current suturing devices are not well suited for endoluminal suturing applications.

[0005] Other solutions may include delivering a needle to the target location via a needle delivery device, then grasping the needle by a needle driver attached to an end of another instrument with a flexible shaft for suturing operation. The flexible shaft needle driver, however, can be challenging to use due to the need to align the needle and maintain a large grasping force on the needle to prevent it from slipping or changing the needle angle while driving through tissue.SUMMARY

[0006] Recognized herein is a need for suturing devices suitable for robotic endoscopic platforms or used endoluminally with reduced size and improved articulation and / or flexibility of the suturing device. The present disclosure provides an improved instrument for robotic endoluminal operations. In some embodiments, the improved instrument may be a hybrid of a grasper and a suturing device. The instrument may be capable of converting between a grasper and a suturing device instrument intraoperatively. In a grasper configuration or grasper mode, the instrument can operate as a stand-alone grasper. In a suturing device configuration or suturing mode, the instrument can function and perform suturing operations. The conversion between the grasper and suturing mode can be performed intraoperatively. For instance, the instrument may be inserted through a working channel of an endoscopic device in a grasper mode, and once it reaches the target site within passageway such as a human body part (e.g., colon), it may perform operations in a grasper mode or a suturing mode and switchable between the two modes. The conversion or switching can be performed while the instrument is placed inside of the passageway. For instance, when it is desired, the grasper can be converted to a suturing device that passes a needle (e.g., double-tipped) back and forth between a pair of jaws while theinstrument is inside of the human body part. In some cases, the conversion to a suturing device may comprise intraoperatively coupling the needle to at least one of the jaws of the instrument while the instrument is placed inside of the body. In some cases, the conversion from a suturing device to a grasper may comprise intraoperatively de-coupling the needle from the instrument while the instrument is placed inside of the body.

[0007] The instrument of the present disclosure may have a reduced overall diameter or can pass through a working channel with a reduced diameter at least due to the capability of intraoperative conversion from a grasper to a suturing instrument. The robotic platform herein may allow the instrument to be placed into an anatomy before coupling a needle to the end effector of the instrument. This beneficially minimizes the overall size and length of the end effector for placing through a working channel of an endoscope (e.g., which would have been limited by a chord length of a suture needle). Compared to the conventional devices where the needle is pre-loaded to the suturing instrument where the minimum diameter of a working channel is restrained by the needle length (e.g., needle that is pre-loaded / grasped by the grasper may not be able to pass through a working channel with a diameter smaller than a chord length of the needle), the capability of grasping a needle in an intraoperative fashion beneficially allows for inserting an instrument for suturing with a needle with a length longer than an inner diameter of a working channel of the endoscope (e.g., needle length is 8mm, 9 mm or longer whereas the inner diameter of a working channel is no greater than 5 mm, 6 mm or 7 mm).

[0008] In an aspect of the present disclosure, a hybrid instrument for endoluminal operation is provided. The hybrid instrument comprises: a flexible shaft comprising an articulatable bending section; an end effector comprising a pair of jaws located at a distal end of the bending section. The end effector is switchable between a grasper mode and a suturing mode at least by changing a close angle limit of the pair of jaws. When the end effector switches from the grasper mode to the suturing mode, a drive mechanism is engaged to limit the close angle limit of the pair of jaws.

[0009] In some embodiments, the end effector comprises a drive mechanism configured to change the close angle limit of the pair of jaws when the end effector switches from the grasper mode to the suturing mode. In some cases, the drive mechanism comprises a pulley configured to drive a flat wire for exchanging a needle between the pair of jaws. In some instances, the pulley comprises a cam surface to change the close angle limit of the pair of jaws. For example, the needle is transferrable between each jaw. In some instances, the needle is couplable to each jaw such that it is retained by a needle coupling mechanism within the jaw. For example, the needle coupling mechanism comprises a flat wire. In some cases, the flat wire iscontrolled to engage with a relief structure of the needle at a first end and disengage with a relief structure of the needle at a second end to transfer the needle from one jaw to the other. In some embodiments, the flat wire is located within the end effector.

[0010] In some embodiments, the surgical instrument is robotically controlled. In some embodiments, the surgical instrument is inserted through a first channel of an endoscopic device. In some cases, the surgical instrument is switched to the grasper mode when it is inserted through the first channel of the endoscopic device. In some cases, a needle is delivered via a delivery instrument via a second channel of the endoscopic device. In some cases, the needle is received by the end effector of the surgical instrument when then surgical instrument is switched to the suturing mode. In some instances, the end effector receives the needle by grasping the needle within a needle plane. In some instances, the needle passes through a hole located at each of the pair of jaws. In some embodiments, the close angle limit of the pair of jaws in the suturing mode is greater than the close angle limit in the grasper mode.

[0011] In another aspect, a method of operating a surgical instrument is provided. The method comprises: delivering a needle to a target site using a needle delivery instrument via a first channel of an endoscopic device; inserting the surgical instrument via a second channel of the endoscopic device in a grasper mode; and switching the end effector of the surgical instrument into a suturing mode to couple the needle at the target site.

[0012] In some embodiments, the end effector comprises a pair of jaws. In some cases, switching the end effector of the surgical instrument into the suturing model comprises changing a close angle limit of the pair of jaws. In some cases, the close angle limit of the pair of jaws in the suturing mode is greater than the close angle limit in the gras per mode. In some instances, the end effector comprises a drive mechanism configured to change the close angle limit of the pair of jaws.

[0013] In some embodiments, the method further comprises in the suturing mode, actuating a needle coupling mechanism to exchange the needle between the jaws. In some cases, the needle coupling mechanism is located within the end effector. In some cases, the needle coupling mechanism comprises a flat wire actuated to engage or disengage with a relief structure of the needle.

[0014] It should be noted that the provided suturing device, end effector, endoscope components and various components of the device can be used in various minimally invasive surgical procedures, therapeutic or diagnostic procedures that involve various types of tissue including heart, bladder and lung tissue, and in other anatomical regions of a patient’s body such as a digestive system, including but not limited to the esophagus, liver, stomach, colon, urinarytract, or a respiratory system, including but not limited to the bronchus, the lung, and various others. The devices and systems can be used in any subject that may or may not involve human body, animal, or tissue.INCORPORATION BY REFERENCE

[0015] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. To the extent publications and patents or patent applications incorporated by reference contradict the disclosure contained in the specification, the specification is intended to supersede and / or take precedence over any such contradictory material.BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings (also “Figure” and “FIG.” herein), of which:

[0017] FIG. 1 shows an example of an end effector, in accordance with some embodiments of the present disclosure.

[0018] FIG. 2 schematically shows an example of a surgical instrument, in accordance with embodiments of the present disclosure.

[0019] FIGs. 3-7 shows examples of a hybrid end effector, in accordance with some embodiments of the present disclosure.

[0020] FIG. 8 shows an example of coupling a needle by the end effector intraoperatively.

[0021] FIG. 9 shows an example of a needle delivery instrument.

[0022] FIG. 10 illustrates an example of a flexible endoscope.

[0023] FIG. 11 shows an example of a robotic endoscope (e.g., gastroscope or colonoscope).

[0024] FIG. 12 and FIG. 13 show an example of an instrument driving mechanism (IDM) providing mechanical interface to the handle portion of the robotic endoscope.

[0025] FIG. 14 shows an example of a distal tip of an endoscope.DETAILED DESCRIPTION

[0026] While various embodiments of the invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions may occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed.

[0027] As described above, current suturing devices are not suitable for endoluminal use applications. For example, current suturing instruments are either too large in diameter resulting in increased dimension of the endoscopic device’s overall dimension, or lacking flexibility to be articulatable in two or more degrees of freedom (e.g., due to an engaging blade or flat wire for retaining needle within a jaw). Additionally, existing suturing instrument with a flexible shaft and a pair of juxtaposed jaws may require the needle to be installed with the end effector prior to inserting the instrument through the trocar (working channel of an endoscope) and to the surgical site. The needle remains coupled to the end effector throughout the procedure resulting the instrument can only be used as a suturing tool.

[0028] The present disclosure provides an improved instrument for robotic endoluminal operations. The instrument may be a hybrid of a grasper and a suturing device. The instrument can convert between a grasper and a suturing device instrument intraoperatively. In a grasper configuration, the instrument can operate as a stand-alone grasper. In a suturing device configuration, the instrument can function and perform suturing operations. The conversion between the grasper and suturing device can be performed intraoperatively. For instance, the instrument may be inserted through a working channel of an endoscopic device as a grasper, and once it reaches the target site within a human body part (e.g., colon), it may perform operations as a grasper or a suturing apparatus. When it is desired, the grasper can be converted to a suturing device that passes a needle (e.g., double-tipped) back and forth between a pair of jaws while the instrument is inside of the human body part. In some cases, the conversion to a suturing device may comprise intraoperatively coupling the needle to at least one of the jaws of the instrument while the instrument is placed inside of the body. In some cases, the conversion from a suturing device to a grasper may comprise intraoperatively de-coupling the needle from the instrument while the instrument is placed inside of the body.

[0029] The instrument of the present disclosure may have a reduced overall diameter or can pass through a working channel with a reduced diameter at least due to the capability of intraoperative conversion from a grasper to a suturing instrument. The robotic platform herein may allow the instrument to be placed into the anatomy before coupling the needle to the endeffector of the instrument. This beneficially minimizes the overall size and length of the end effector for placing through a working channel of an endoscope. Compared to the conventional devices where the needle is pre-loaded to the suturing instrument where the minimum diameter of a working channel is restrained by the needle length (e.g., needle that is pre-loaded / grasped by the grasper may not be able to pass through a working channel with a diameter smaller than a chord length of the needle), the capability of grasping a needle in an intraoperative fashion beneficially allows for inserting an instrument for suturing with a needle with a length longer than an inner diameter of a working channel (e.g., needle length is 8mm, 9 mm or longer whereas the inner diameter of a working channel is no greater than 5 mm, 6 mm or 7 mm).

[0030] In some cases, the robotic platform may first insert a needle delivery instrument (e.g., needle delivery instrument 900 shown in FIG. 8 and FIG. 9) to the target site within a subject or body and deliver a needle (e.g., 9 mm long needle) through a first working channel of a robotic endoscope. The working channel may have an inner diameter (e.g., no greater than 6 mm) smaller than a dimension of the needle. Next, the robotic platform may insert the instrument through a second working channel and convert to a suturing device by coupling the needle intraoperatively. Both the first working channel and the second working channel may have an inner diameter at least 20%, 30%, 40%, 50% less than a dimension of the needle. The reduced working channel diameter may beneficially allow for an endoscopic device with a reduced outer diameter (e.g., no greater than 20 mm, 15 mm, 10 mm, 9 mm, 8 mm, 7 mm, 6 mm, 5 mm, 4.5 mm, 4 mm or smaller outer diameter).

[0031] In another aspect, a method of operating a surgical instrument is provided. The method comprises: delivering a needle to a target site using a needle delivery instrument via a first channel of an endoscopic device; inserting the surgical instrument via a second channel of the endoscopic device in a grasper mode; and switching the end effector of the surgical instrument into a suturing mode to couple the needle at the target site.

[0032] In some embodiments, the end effector comprises a pair of jaws. In some cases, switching the end effector of the surgical instrument into the suturing model comprises changing a close angle limit of the pair of jaws. In some cases, the close angle limit of the pair of jaws in the suturing mode is greater than the close angle limit in the gras per mode. In some instances, the end effector comprises a drive mechanism configured to change the close angle limit of the pair of jaws.

[0033] In some embodiments, the method further comprises in the suturing mode, actuating a needle coupling mechanism to exchange the needle between the jaws. In some cases, the needle coupling mechanism is located within the end effector. In some cases, the needlecoupling mechanism comprises a flat wire actuated to engage or disengage with a relief structure of the needle.

[0034] Unlike current devices that include a component (e.g., blade, flat wire) that is not bendable in at least a thickness plane of the blade along the entire shaft, the instrument of the present disclosure may allow for articulation or bending of the instrument along multiple axes / planes. In some embodiment, the instrument herein may confine the flat wire to the end effector or tip portion where the end effector can be coupled to a multi-axis positioning system such as an articulatable elongated member. This beneficially allows for an articulable instrument that can steer or articulate (e.g., up, down, pitch, yaw, or any direction in-between) at least the distal portion (e.g., end effector) of the suturing instrument in multiple degrees of freedom (DOFs) and avoids the bending limitation of the flat wire.

[0035] While exemplary embodiments will be primarily directed at a robotic instrument device or system for colonoscope or gastroscope, one of skill in the art will appreciate that this is not intended to be limiting, and the devices described herein may be used for other therapeutic or diagnostic procedures and in various anatomical regions of a patient’s body. The provided suturing device or system can be utilized in urology, gynecology, rhinology, otology, laryngoscopy, gastroenterology with the endoscopes, combined devices including endoscope and instruments, endoscopes with localization functions, one of skill in the art will appreciate that this is not intended to be limiting, and the devices described herein may be used for other therapeutic or diagnostic procedures and in other anatomical regions of a patient’s body, such as such as brain, heart, lungs, intestines, eyes, skin, kidney, liver, pancreas, stomach, uterus, ovaries, testicles, bladder, ear, nose, mouth, soft tissues such as bone marrow, adipose tissue, muscle, glandular and mucosal tissue, spinal and nerve tissue, cartilage, hard biological tissues such as teeth, bone and the like, as well as body lumens and passages such as the sinuses, ureter, colon, esophagus, lung passages, blood vessels and throat, and various others, in the forms of: BronchoScope, NeuroendoScope, EncephaloScope, Ophthalmoscope, OtoScope, RhinoScope, LaryngoScope, GastroScope, EsophagoScope, BronchoScope, ThoracoScope, PleuroScope, AngioScope, MediastinoScope, NephroScope, GastroScope, DuodenoScope, CholeodoScope, CholangioScope, LaparoScope, AmioScope, UreteroScope, HysteroScope, CystoScope, ProctoScope, ColonoScope, ArthroScope, SialendoScope, Orthopedic Endoscopes, and others, in combination with various tools or instruments.

[0036] It should be noted that the provided hybrid instrument, device, endoscope components and various components of the device can be used in various minimally invasive surgical procedures, therapeutic or diagnostic procedures that involve various types of tissueincluding heart, bladder and lung tissue, and in other anatomical regions of a patient’s body such as a digestive system, including but not limited to the esophagus, liver, stomach, colon, urinary tract, or a respiratory system, including but not limited to the bronchus, the lung, and various others. The devices and systems can be used in any subject that may or may not involve human body, animal, or tissue.

[0037] The systems and apparatuses herein can be combined in one or more of many ways to provide improved diagnosis and therapy to a patient. Systems and apparatuses provided herein can be combined with existing methods and apparatus to provide improved diagnosis, surgery operations of various tissues and organs, for example. It is to be understood that any one or more of the structures and steps as described herein can be combined with any one or more additional structures and steps of the methods and apparatus as described herein, the drawings and supporting text provide descriptions in accordance with embodiments.

[0038] Whenever the term “at least,” “greater than,” or “greater than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “at least,” “greater than” or “greater than or equal to” applies to each of the numerical values in that series of numerical values. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.

[0039] Whenever the term “no more than,” “less than,” or “less than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “no more than,” “less than,” or “less than or equal to” applies to each of the numerical values in that series of numerical values. For example, less than or equal to 3, 2, or 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.

[0040] As used herein, the terms distal and proximal may generally refer to locations referenced from the apparatus, and can be opposite of anatomical references. For example, a distal location of a primary shaft or catheter may correspond to a proximal location of an elongate member of the patient, and a proximal location of the primary sheath or catheter may correspond to a distal location of the elongate member of the patient.

[0041] In some embodiments, the hybrid instrument may comprise a jaw mechanism suitable for a robotically controlled flexible instrument. In some embodiments, the instrument may allow for managing the jaw open and close using a pull / pull cable and pulley subsystem located at a proximal end of the instrument. The proximal end may be a handle that is releasably attached to a robotic support or a handheld support.

[0042] The flexible instrument provided by the present disclosure improves a suturing process. For instance, the flexible instrument can function as both a grasper and a suturing device thereby reducing the need of additional tools. For example, the flexible instrument can be used as a grasper before coupling the needle to the jaws, so it can perform additional surgical tasks than either a tissue grasper (which cannot suture) or a suturing device (which cannot be used to grasp tissue). Additionally, the capability of switching between a grasper and a suturing instrument and coupling to a free needle intraoperatively beneficially allows for a reduced dimension of the instrument.

[0043] In an aspect of the present disclosure, a hybrid instrument for endoluminal operation is provided. The hybrid instrument comprises: a flexible shaft comprising an articulatable bending section; an end effector comprising a pair of jaws located at a distal end of the bending section. The end effector is switchable between a grasper mode and a suturing mode at least by changing a close angle limit of the pair of jaws. When the end effector switches from the grasper mode to the suturing mode, a drive mechanism is engaged to limit the close angle limit of the pair of jaws.

[0044] FIG. 1 shows an example of an end effector 100, in accordance with some embodiments of the present disclosure. The end effector 100 may be switchable between a grasper mode (as shown in the example 100) and a needle driver mode (as shown in the example 110). The term “needle driver mode” may also be referred to as suturing mode which are used interchangeably throughout the description.

[0045] The end effector may comprise a pair of jaws 101 that can function as a standalone grasper. In some cases, the close angle limit of the pair of jaws may be different between gasper mode and the needle driver mode. For instance, when the end effector in the grasper mode, the pair of jaws may be able to fully close (i.e., close angle limit is about zero) as shown in FIG. 7. In the grasper mode, the pair of jaws may be in a fully closed state 710 and / or open by an open angle limit 701. When the end effector is in a needle driver mode 110, the angle range for the jaw open and close may be different from that of the grasper mode. For instance, in the needle driver mode, the pair of jaws may not be fully closed where the jaws may be controlled by a flat drive mechanism to have a close angle limit as shown in FIG. 6 (e.g., close angle limit 611 that is greater than zero or greater than the close angle limit in the grasper mode).

[0046] In some cases, the open angle limit of the pair of jaws may also be different between gasper mode and the needle driver mode (also be referred to as suturing mode). Alternatively, the open angle limit in the grasper mode and the needle driver mode may be thesame. The limited open / close angular range of the end effector allows for an efficient suturing operation such as needle exchange between the jaws and desirable suturing path.

[0047] In some embodiments, the instrument or the end effector herein may comprise a flat drive mechanism that can be engaged or disengaged to change at least the close angle limit between the gasper mode and needle driver mode. The mechanical constraints in the drive mechanism (e.g., gear specification and linkage for driving open / close of the jaws) of the end effector may define an open angle limit. Details about the flat drive mechanism that is configured to control or change the close angle limit are described later herein.

[0048] Referring back to FIG. 1, the end effector 100, 110 may comprise two opposing jaws 101 with a set of teeth for grasping. Alternatively, the pair of jaws may not have toothprofile for grasping an object. When the end effector is in the grasper mode 100, the pair of jaws may open and / or close to grasp object such as tissue and the like. The two opposing jaws or pair of jaws may open and close about an axis 113.

[0049] In some embodiments, each jaw may have a hole 103 at the distal end for engaging with a needle 111 when the end effector is in the suturing mode 110. As illustrated in FIG. 1, a suturing needle 111 may be driven within a needle plane (e.g., XY plane). The needle may be a curved needle defining a needle plane. For example, the needle may be a longshouldered needle, a standard 1 / 2 circle, or 180° needle that the needle plane may be perpendicular to the axis 113 (i.e., z axis). The end effector or the jaws may grasp the needle within the needle plane. The end effector may receive the needle by passing the needle through the hole at the each jaw. Those skilled in the art will understand that various needle wire diameters, needle bend radii, needle cross sections, and suture materials are all adaptable to be used in the devices described herein.

[0050] In some cases, the needle may be a double-tipped needle and the needle may be exchanged between the opposing jaws. When the end effector is in the suturing mode 110, the pair of jaws 101 may open and close to drive the curved needle in a circular arc path. As the pair of jaws reach a close angle limit i.e., reach a needle exchange position, a flat drive mechanism of the end effector may be actuated to retain the needle with one of the pair of jaws and the retention of the needle with either jaw can be controlled by the flat drive mechanism based on desired needle operations. The flat drive mechanism can also be actuated to couple and decouple the needle with the pair of jaws. For example, to decouple the needle, the jaws are opened and the flat drive mechanism is controlled to retract and decouple from the needle relief structure thereby unlocking the needle from the jaw where it is retained. Tension on the needle or sutureat that point will remove it from the jaw. Details about the flat drive mechanism are described later herein.

[0051] As described elsewhere herein, the end effector may beneficially allow for an instrument with reduced dimension. As an example, the instrument may have an outer diameter that is no greater than 5 millimeters (mm), 4.9 mm, 4.8 mm, 4.7 mm, 4.6 mm, 4.5mm, 4.4 mm, 4.3 mm, 4.2 mm, 4.1 mm, 4 mm, 3.5 mm, 3 mm, any number in between the above numbers or any number greater than 5 mm or small than 3 mm, and the like where the instrument may drive the suturing operation with a 9 mm long, double-tipped needle between two jaws located at the distal end of the instrument. As an example, a needle arc may be about 20 mm from the pivot axis of the jaws (e.g., axis 113). Needle with greater dimension can be coupled to and operated by the surgical instrument herein. A suture may be fastened to the needle at the middle point 115 along the needle arc.

[0052] The hybrid end effector 100, 110 may be attached to any articulable instrument. As described elsewhere herein, the flat drive mechanism may be located within the distal portion of the flexible / articulable instrument. The hybrid end effector may be attached to a distal end of an instrument with a small diameter (e.g., no greater than 11mm, lOmmn, 9 mm, 8mm, 7mm, 6mm, 5mm, 4.5mm, 4mm or smaller instrument diameter). The embodiments disclosed herein can be combined in one or more of many ways to provide improved diagnosis, treatment, suturing operation and therapy to a patient. The disclosed embodiments can be combined with existing methods and apparatus to provide improved treatment, such as combination with known methods of diagnosis, surgery and surgery of tissues and organs, for example. It is to be understood that any one or more of the structures and steps as described herein can be combined with any one or more additional structures and steps of the methods and apparatus as described herein, the drawings and supporting text provide descriptions in accordance with embodiments.

[0053] FIG. 2 shows an example of a surgical instrument 200, in accordance with some embodiments of the present disclosure. The surgical instrument 200 may comprise an end effector 201 located at a distal end of an elongate member. The end effector may be a hybrid of a grasper and a needle driver as described in FIG. 1 and elsewhere herein. The end effector 201 can be located at the distal end of a flexible instrument shaft. Alternatively, the end effector 201 can be located at the distal end of a rigid instrument shaft or at the end of a shaft with a positioning system for controlling the position and orientation of the instrument with respect to a primary shaft. The end effector 201 can be attached to any positioning system that may or may not be flexible. For example, the end effector may be attached to a distal end of a rigid robotic systemcomprising links and joints. The end effector can be used in conjunction with any surgical tools or systems that may or may not perform endoluminal operations.

[0054] In some cases, the surgical instrument 200 can be coupled to or releasably integrated into a manual device for laparoscopy or endoscopy, where the manual device may have a rigid, semi-rigid or flexible shaft and a handle to be operated by a human hand. In some cases, the surgical instrument 200 can be coupled to or releasably integrated into a robotic device for laparoscopy or endoscopy, where the robotic device may have a rigid, semi-rigid or flexible shaft and a handle to be releasably coupled to a robotic instrument drive mechanism (TDM).

[0055] In some embodiments, the elongate member of the surgical instrument 200 may be an articulatable, flexible member comprising a bending section 203, a flexible shaft 205 and a proximal end 207. In some cases, the proximal end 207 may be a handle that is releasably attached to a robotic support. In some cases, the proximal end 207 may comprise driving components (e.g., pulley) that are releasably coupled to an instrument driving mechanism to drive an operation of the end effector (e.g., open / close of jaws to grasp tissue, actuate the flat drive mechanism for needle exchange / suturing operation, couple / decouple needle, and / or the motion (e.g., articulation) of the bending section 203.

[0056] In some embodiments, the pair of jaws may be actuated to open and close about a center plane. The open and close of the jaws may be controlled by the robotic IDM or by a user grasping and relaxing the grippers on an in-line handle in a manual device. In the case of a manual device, the handle grippers may be spring-biased open.

[0057] In some embodiments, the proximal end 207 may comprise a mechanical interface to allow the surgical instrument to be releasably coupled to an instrument driving mechanism attached to a robotic support or a hand-held controller. The instrument driving mechanism (IDM) can be the same as the IDM 1231, 1233 as illustrated in FIG. 12 and FIG. 13. The IDM may comprise a set of motors 1235 that are actuated to rotationally drive a set of pull wires of the elongate member. The proximal end 207 may be mounted onto the instrument drive mechanism 1231 or 1233 so that its pulley / capstans assemblies are driven by the set of motors. The number of pulleys may vary based on the pull wire configurations. In some cases, at least one, two, three, four, or more pull wires may be utilized for articulating the flexible surgical instrument and for driving the operation or motion of the end effector. In some cases, one pull wire may be coupled to and driven by a pulley. For example, one pull wire may drive to open the jaw of the end effector, one pull wire may drive to close the jaw, one pull wire may drive a flat drive mechanism to extend and retract a flat wire for needle exchange operation. In some cases, more than one wires may be coupled to a driven pulley. For example, two or more wires may be coupled to thesame driven pulley antagonistically to drive the needle driver end effector motion such that rotation of the pulley provides tension to one wire(s) while slacking the other(s).

[0058] The bending section 203 may be articulated in two or more degrees of freedom. The articulation of the bending section 203 may be controlled by applying force to the distal tip portion via the one or multiple pull wires. A distal end of the one or more pull wires may be attached to the distal end of the surgical instrument 200. In the case of multiple pull wires, pulling one wire at a time may change the orientation of the end effector 201 to pitch up, down, left, right or any direction needed. In some cases, the pull wires may be anchored at the distal tip portion of the surgical instrument 200, running through the bending section, and entering the proximal end they are coupled to a driving component (e.g., pulley). The pulley may interact with an output shaft from the robotic system. In some cases, one or more of the pull wires may be utilized for the end effector operation such as couple / decouple a needle, open / close of jaws, needle exchange and the like.

[0059] In some embodiments, the proximal end or portion of one or more pull wires may be operatively coupled to various mechanisms (e.g., gears, pulleys, capstans, etc.) in the proximal end. The pull wire may be a metallic wire, cable or thread, or it may be a polymeric wire, cable or thread. The pull wire can also be made of natural or organic materials or fibers. The pull wire can be any type of suitable wire, cable or thread capable of supporting various kinds of loads without deformation, significant deformation, or breakage. The distal end / portion of one or more pull wires may be anchored or integrated to the distal portion of the surgical instrument 200, such that operation of the pull wires by the control unit may apply force or tension to the distal portion which may steer or articulate (e.g., up, down, pitch, yaw, or any direction inbetween) at least the distal portion (e.g., flexible section) of the surgical instrument. The pull wires may be made of any suitable material such as stainless steel (e.g., SS316), metals, alloys, polymers, nylons or biocompatible material. In some embodiments, different pull wires may be made of different materials for varying the load bearing capabilities of the pull wires.

[0060] The end effector 201 may be a hybrid of grasper and needle driver as described elsewhere herein. The end effector may be attached to the distal portion of the surgical instrument 200. The end effector may have two (e.g., roll and translation), three (e.g., roll and articulation), four (e.g., roll, articulation and translation) or more degrees of freedom via a manipulation of the surgical instrument. For example, the end effector may have a roll movement (e.g., rotatable about the longitudinal axis of the elongate member), articulatable about two axes (e.g., via the articulation of the bending section) and may have translational movement (e.g., insertion and retraction of the device). In some cases, the end effector may be integrated to thedistal portion of the bending section 203 and may not have roll movement relative to the bending section. In some cases, a roll movement of the end effector may be achieved via the roll movement of the elongate member, a wrist located at the distal end of the bending section 203 or a combination of both. The end effector 201 as described herein may contain the flat drive mechanism substantially within the end effector such that the flat wire bending limitation may not limit the articulation motion of the end effector.

[0061] The present disclosure provides an improved surgical instrument that can be used with an endoscope or colonoscope to perform operations related to suturing during upper and lower gastrointestinal (GI) tract endoscopy, gastric endoscopy, small bowel endoscopy or other procedures. The hybrid end effector with the capability of coupling and decoupling needle intraoperatively may beneficially ease insertion, manipulation, and retraction of an endoscope during colonoscopy.

[0062] FIGs. 3-7 show examples of a hybrid end effector 300, in accordance with some embodiments of the present disclosure. The hybrid end effector 300 can be the same as the end effector describe din FIG. 1. The hybrid end effector may comprise a pair of jaws 301, 303. In the illustrated example, the end effector may comprise a pair of jaws 301, 303 that each jaw may have a hole at the distal end for engaging with a needle. In some cases, the hole 305 may have a cylindrical shape. The hole may be shaped as an arc along the axial axis and / or have a profile to match an arc of the needle. In some cases, a needle hole 305 may have a profile (e.g., arc shaped to match the needle) that beneficially allows for controlling an orientation of the needle when it is grasped within the jaw, while maintaining a generous tolerance to ensure a fitment of the needle.

[0063] The end effector may comprise a mechanism for driving open / close of the opposing jaws. In some embodiment, as shown in FIG. 3, the pair of jaws 301, 303 may be driven to pivot about a first pivot 311 to open and close. The first pivot may be located on the distal end of the end effector clevis. The jaw angle may be driven by a pulley 319 that pivots about a second pivot 313. The second pivot may be located on the proximal end effector clevis that is proximal to the first pivot. As shown in the example, the pulley 319 may be coupled to one jaw 301 via a gear tooth interface and to the second jaw 303 via a linkage system 317. It should be noted that other suitable mechanism may be employed for driving the open / close of the jaws. The mechanism for driving the open / close of the jaws in the gasper mode and the needle driver mode can be the same.

[0064] In some embodiments, the end effector may comprise a flat drive mechanism for switching the end effector between a grasper mode and a needle driver mode. As describe elsewhere herein, a close angle limit of the pair of jaws may change between a grasper mode anda suturing mode (or needle driver mode). When the end effector switches from the grasper mode to the suturing mode, the flat drive mechanism is engaged to limit the close angle limit of the pair of jaws (and an open angle limit of the pair of jaws). Additionally, the flat drive mechanism may be controlled to couple / decouple a needle and retain the needle with one of the jaws. FIG. 4 shows an example of the flat drive mechanism 400, in accordance with some embodiments of the present disclosure.

[0065] The pair of jaws may comprise structures 411, 413 to accommodate the flat drive mechanism. In some embodiments, the flat drive mechanism may comprise a flat wire 401 for retaining the needle 111. The flat wire 401 may be slidable within a receiving structure (e.g., slot) 411 of the jaws to be engaged with each jaw. The receiving structure may secure the flat wire in place while allowing it to slide / translate within the structure. In some cases, the pair of jaws may comprise structures such as a flat wire cover 413 to form the receiving structure 411 thereby securing the flat wire. In some cases, when one end of the flat wire advances distally, the advanced end may engage with a first relief structure 403-1 in the needle while the other end of the flat wire disengages with a second relief structure of the needle 403-2. The needle relief structure may be a slot or a receiving structure that can accommodate a shape of the flat wire (e.g., distal tip or a distal end of the flat wire). The flat wire may be sufficiently rigid to retain the needle once the flat wire is engaged with the needle relief structure. The flat wire may be a blade can allow for bending along the thickness of the blade, but not articulation of the end effector in a plane orthogonal to the width of the blade / flat wire.

[0066] In some embodiments, the flat wire may be driven to advance one end while retracting the other end to engage and disengage with the needle at one needle relief structure. In some embodiments, the flat drive mechanism 400 may comprise a pulley to drive the flat wire. As illustrated in FIG. 5, the flat wire may be driven by a pulley 501 (the second pulley of the end effector) which pivots about the first pivot 311 in the end effector clevis. As described above, the needle 411 is retained in one of the jaws via the flat wire that is driven to advance or retract relative to each jaw. During the suturing operation, a needle is exchanged between the two jaws. The flat wire may engage with a relief structure at either tip of the needle, preventing its release from the respective jaw.

[0067] The second pulley 501 may also be used to limit a jaw close angle in the suturing mode. In the suturing mode, the jaws may have a close angle limit. The close angle limit ensures that when the pair of jaws reach the close angle limit, the needle also reaches the exchange position such that the flat wire is engaged with one relief structure of the needle. The rotation angle or orientation of the second pulley may be controlled to limit the jaw close angle at a pre-determined angle such that the flat wire can engage with the needle relief structure when the jaws are at the pre-determined angle.

[0068] In some embodiments, the second pulley 501 or the flat drive pulley 501 may comprise a cam surface 503. The cam surface may have a surface profile against which a spring- biased member 505 is slidably engaged. The surface profile of the cam may define the jaw close limit angle. As shown in FIG. 6, as the flat drive pulley 503 is rotated, the spring-biased member 505 may move along its axis to engage or disengage from a corresponding relief in one of the jaws. The rotation of the flat drive pulley may be limited, for example, by a pin 505 extending from the interior surface of one of the clevis arms. The close angle limit 611 may be defined when the pin 505 reaches the stopping edge of the cam surface at either end i.e., state 2 610 and state 3 630.

[0069] FIG. 6 shows various states of the end effector in both the grasper mode and the suturing mode. During insertion through a working channel to a target or surgical site, the flat wire pulley may be in state 1 600. In state 1, the flat wire pulley may disengage the jaw close limiter or the pin 505, allowing the pair of jaws to be fully closed. This beneficially allows the end effector to pass through a smaller diameter working channel as illustrate in FIG. 7 710. Once the end effector of the instrument reaches the target site and is ready to be coupled to a needle, the jaws may be opened and the flat wire is cycled to one side.

[0070] FIG. 8 shows an example of coupling a needle 910 by the end effector of the suturing instrument 920 intraoperatively. As shown in FIG. 8, jaws of the end effector 920 may be driven to open to receive the needle 910 as shown in the example 800. The needle 910 may be delivered to the target site via a secondary instrument 900 as shown in FIG. 9. The jaws of the hybrid instrument 920 may be closed down around the needle as shown in the example 810 by passing the needle through the holes of the jaws. Once closed, the flat wire may be cycled to the opposite side, engaging with the needle relief structure and the needle can be removed from the secondary instrument.

[0071] As shown in FIG. 9, the needle may be delivered using a delivery tool 900 to a target location to be grabbed by the hybrid surgical instrument. In some cases, the needle delivery device 900 may be a separate instrument. For instance, a needle and suture may be loaded into a specialized holder which is passed through an instrument channel 901 of the endoscope (e.g., colonoscope). In some cases, the needle delivery device may be articulatable such as comprising an articulatable bending section to allow it to be positioned for ease of grasping the needle. The articulation may be actuated robotically or manually. In some cases, the needle delivery device may be passed through the auxiliary channel in the colonoscope.

[0072] The opening angle limit of the pair of jaws in the suturing mode and the grasper mode may or may not be the same. In some cases, the opening angle of the jaw is limited by the gear teeth configuration 703 and linkage system 705. FIG. 7 shows an example of the opening angle limit 701 where the opening angle is restricted by the gear teeth 703 and / or a dimension of the linkage 705.

[0073] Referring back to FIG. 6, once the end effector couples the needle or when the needle is retained in the jaw of the surgical instrument, the instrument may switch to a suturing mode to perform operations such as closing wounds and pulling tissue into apposition. The flat drive pulley may be in stage 2 610 to engage the jaw limiter 505 thereby limiting a close angle of the pair of jaws 611. The flat drive pulley may cycle between state 2 610 and state 3 630 for the needle exchange. After the suturing process is completed, the surgical instrument may decouple the needle from the end effector. In some cases, the instrument may decouple a needle from the instrument by opening the pair of jaws while toggling the needle retention mechanism to unlock the needle from the jaw where it is currently retained. After the needle is unlocked, tension on the needle or the suture thread will separate the needle from the jaw. Alternatively, the needle may be coupled to a withdraw accessory, which may or may not be included in the needle delivery tool. For instance, the needle may be driven through the withdraw accessory in a desired location, then the end effector may be controlled to open the jaws and toggle the needle retention mechanism to unlock the needle and release it to the needle withdraw accessory.

[0074] As an example of a workflow in the suturing mode, the needle may be positioned for a bite with respect to a target tissue, the jaws of the surgical instrument may be controlled to close to penetrate the needle through the tissue, the jaw without the needle ensures the needle fully penetrates the tissue and is in a position to transfer the needle after the jaws have been closed, once the jaws reach the close angle limit position, the end effector is controlled to perform a needle transfer or needle exchange by actuating the flat drive mechanism. Next, the jaws of the surgical instrument are controlled to open and pull the needle and suture through the tissue. The above operations may be repeated.

[0075] As described above, the actuation or driving mechanism of the end effector may comprise one or more pull wires. The one or more pull wires may comprise one or more pull wires to open / close the jaws (e.g., rotating the first pulley), and one pull wire to control the flat drive mechanism for needle exchange (e.g., rotating the second pulley).

[0076] The provided surgical instrument may be utilized by any robotic endoluminal systems or platforms. Alternatively, the surgical instrument can be utilized by manual endoluminal devices. In an aspect of the invention, the surgical instrument may be insertedthrough a working channel of a flexible endoscope to perform suturing operations as described above. The surgical instrument may be independently steerable from the endoscope. For example, the surgical instrument shaft may be advanced and retracted and rotated relative to the flexible endoscope. FIG. 10 illustrates an example of a flexible endoscope 1000, in accordance with some embodiments of the present disclosure. As shown in FIG. 10, the flexible endoscope 1000 may comprise a handle / proximal portion 1009 and a flexible elongate member to be inserted inside of a subject. The flexible elongate member can be the same as the one described above. In some embodiments, the flexible elongate member may comprise a proximal shaft (e.g., insertion shaft 1001), steerable tip (e.g., tip 1005), a steerable section (active bending section 1003) and a proximal shaft section 100. The endoscope 1000 may also be referred to as steerable catheter assembly as described elsewhere herein. 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 an instrument driving mechanism and can be disposed of. In some embodiments, the endoscope may contain varying levels of stiffness along the shaft, as to improve functional operation.

[0077] The endoscope or steerable catheter assembly 1000 may comprise a handle portion 1009 that may include one or more components configured to process image data, provide power, or establish communication with other external devices. For instance, the handle portion may include a circuitry and communication elements that enables electrical communication between the steerable catheter assembly 1000 and an instrument driving mechanism (not shown), and any other external system or devices. In another example, the handle portion 1009 may comprise circuitry elements such as power sources for powering the electronics (e.g., camera, electromagnetic sensor and LED lights) of the endoscope.

[0078] The one or more components located at the handle may be optimized such that expensive and complicated components may be allocated to the robotic support system, a handheld controller or an instrument driving mechanism thereby reducing the cost and simplifying the design of the disposable endoscope. The handle portion or proximal portion may provide an electrical and mechanical interface to allow for electrical communication and mechanical communication with the instrument driving mechanism. The instrument driving mechanism may comprise a set of motors that are actuated to rotationally drive a set of pull wires of the catheter. The handle portion of the catheter assembly may be mounted onto the instrument drive mechanism so that its pulley / capstans assemblies are driven by the set of motors. The number of pulleys may vary based on the pull wire configurations. In some cases, one, two, three, four, or more pull wires may be utilized for articulating the flexible endoscope or catheter.

[0079] The handle portion may be designed allowing the robotic endoscope to be disposable at reduced cost. For instance, classic manual and robotic endoscopes may have a cable in the proximal end of the endoscope handle. The cable often includes illumination fibers, camera video cable, and other sensors fibers or cables such as electromagnetic (EM) sensors, or shape sensing fibers. Such complex cable can be expensive adding to the cost of the endoscope. The provided robotic endoscope may have an optimized design such that simplified structures and components can be employed while preserving the mechanical and electrical functionalities. In some cases, the handle portion of the robotic endoscope may employ a cable-free design while providing a mechanical / electrical interface to the catheter.

[0080] The electrical interface (e.g., printed circuit board) may allow image / video data and / or sensor data to be received by the communication module of the instrument driving mechanism and may be transmitted to other external devices / systems. In some cases, the electrical interface may establish electrical communication without cables or wires. For example, the interface may comprise pins soldered onto an electronics board such as a printed circuit board (PCB). For instance, a receptacle connector (e.g., the female connector) is provided on the instrument driving mechanism as the mating interface. This may beneficially allow the endoscope to be quickly plugged into the instrument driving mechanism or robotic support without utilizing extra cables. Such type of electrical interface may also serve as a mechanical interface such that when the handle portion is plugged into the instrument driving mechanism, both mechanical and electrical coupling is established. Alternatively or in addition to, the instrument driving mechanism may provide a mechanical interface only. The handle portion may be in electrical communication with a modular wireless communication device or any other user device (e.g., portable / hand-held device or controller) for transmitting sensor data and / or receiving control signals.

[0081] In some cases, the handle portion 1009 may comprise one or more mechanical control modules such as lure 1011 for interfacing the irrigation system / aspiration system. In some cases, the handle portion may include a lever / knob for articulation control. Alternatively, the articulation control may be located at a separate controller attached to the handle portion via the instrument driving mechanism.

[0082] The endoscope may be attached to a robotic support system or a hand-held controller via the instrument driving mechanism. The instrument driving mechanism may be provided by any suitable controller device (e.g., hand-held controller) that may or may not include a robotic system. The instrument driving mechanism may provide mechanical and electrical interface to the steerable catheter assembly 1000. The mechanical interface may allowthe steerable catheter assembly 1000 to be releasably coupled to the instrument driving mechanism. For instance, the handle portion of the steerable catheter assembly can be attached to the instrument driving mechanism via quick install / release means, such as magnets, spring- loaded levers and the like. In some cases, the steerable catheter assembly may be coupled to or released from the instrument driving mechanism manually without using a tool. Details about the instrument driving mechanism are described later herein.

[0083] In the illustrated example, the distal tip of the catheter or endoscope shaft is configured to be articulated / bent in two or more degrees of freedom to provide a desired camera view or control the direction of the endoscope. As illustrated in the example, imaging device (e.g., camera), position sensors (e.g., electromagnetic sensor) 1007 is located at the tip of the catheter or endoscope shaft 1005. For example, line of sight of the camera may be controlled by controlling the articulation of the active bending section 1003. In some instances, the angle of the camera may be adjustable such that the line of sight can be adjusted without or in addition to articulating the distal tip of the catheter or endoscope shaft. For example, the camera may be oriented at an angle (e.g., tilt) with respect to the axial direction of the tip of the endoscope with the aid of an optical component.

[0084] The distal tip 1005 may be a rigid component that allows for positioning sensors such as imaging devices (e.g., camera) and other electronic components (e.g., LED light source) being embedded at the distal tip. Depending on the type of the endoscope, the distal tip may comprise other sensors such as electromagnetic (EM) sensors or inertial measurement units.

[0085] The robotic endoscope may or may not have real-time EM tracking capability. In the case that the robotic endoscope is embedded with EM sensor, the EM sensor comprising of one or more sensor coils embedded in one or more locations and orientations in the medical instrument (e.g., tip of the endoscopic tool) measures the variation in the EM field created by one or more static EM field generators positioned at a location close to a patient. The location information detected by the EM sensors is stored as EM data. The EM field generator (or transmitter), may be placed close to the patient to create a low intensity magnetic field that the embedded sensor may detect. The magnetic field induces small currents in the sensor coils of the EM sensor, which may be analyzed to determine the distance and angle between the EM sensor and the EM field generator. For example, the EM field generator may be positioned close to the patient during a procedure to locate the EM sensor position in 3D space or may locate the EM sensor position and orientation in 5D or 6D space. This may provide a visual guide to an operator when driving the endoscope towards the target site.

[0086] The endoscope may have a unique design in the elongate member. In some cases, the active bending section 1003 and the proximal shaft 1001 of the endoscope may consist of a single tube that incorporates a series of cuts (e.g., reliefs, slits, etc.) along its length to allow for improved flexibility, a desirable stiffness as well as the anti -prolapse feature (e.g., features to define a minimum bend radius).

[0087] As described above, the active bending section 1003 may be designed to allow for bending in two or more degrees of freedom (e.g., articulation). A greater bending degree such as 180 and 270 degrees (or other articulation parameters for clinical indications) can be achieved by the unique structure of the active bending section. In some cases, the active bending section and / or the passive section may be fabricated separately as a modular component and assembled to the proximal shaft. In some cases, the cut patterns of the active bending and passive sections may be different such that at least the minimum bend radius of the two sections may be different. In some cases, a variable minimum bend radius along the axial axis of the elongate member may be provided such that an active bending section or the passive section may comprise two or more different minimum bend radii.

[0088] The articulation of the endoscope may be controlled by applying force to the distal end of the endoscope via one or multiple pull wires. The one or more pull wires may be attached to the distal end of the endoscope. In the case of multiple pull wires, pulling one wire at a time may change the orientation of the distal tip to pitch up, down, left, right or any direction needed. In some cases, the pull wires may be anchored at the distal tip of the endoscope, running through the bending section, and entering the handle where they are coupled to a driving component (e.g., pulley). This handle pulley may interact with an output shaft from the robotic system.

[0089] In some embodiments, the proximal end or portion of one or more pull wires may be operatively coupled to various mechanisms (e.g., gears, pulleys, capstans, etc.) in the handle portion of the catheter assembly. The pull wire may be a metallic wire, cable or thread, or it may be a polymeric wire, cable or thread. The pull wire can also be made of natural or organic materials or fibers. The pull wire can be any type of suitable wire, cable or thread capable of supporting various kinds of loads without deformation, significant deformation, or breakage. The distal end / portion of one or more pull wires may be anchored or integrated to the distal portion of the catheter, such that operation of the pull wires by the control unit may apply force or tension to the distal portion which may steer or articulate (e.g., up, down, pitch, yaw, or any direction inbetween) at least the distal portion (e.g., flexible section) of the catheter.

[0090] The pull wires may be made of any suitable material such as stainless steel (e.g., SS316), metals, alloys, polymers, nylons or biocompatible material. Pull wires may be a wire,cable or a thread. In some embodiments, different pull wires may be made of different materials for varying the load bearing capabilities of the pull wires. In some embodiments, different sections of the pull wires may be made of different material to vary the stiffness and / or load bearing along the pull. In some embodiments, pull wires may be utilized for the transfer of electrical signals.

[0091] The proximal design may improve the reliability of the device without introducing extra cost allowing for a low-cost single-use endoscope. In another aspect of the invention, a single-use robotic endoscope is provided. The robotic endoscope may be a gastroscope and can be the same as the steerable catheter assembly as described elsewhere herein. Traditional endoscopes can be complex in design and are usually designed to be re-used after procedures, which require thorough cleaning, dis-infection, or sterilization after each procedure. The existing endoscopes are often designed with complex structures to ensure the endoscopes can endure the cleaning, dis-infection, and sterilization processes. The provided robotic endoscope can be a single-use endoscope that may beneficially reduce cross-contamination between patients and infections. In some cases, the robotic gastroscope may be delivered to the medical practitioner in a pre-sterilized package and are intended to be disposed of after a single use.

[0092] As shown in FIG. 11, a robotic endoscope (e.g., gastroscope or colonoscope) 1110 may comprise a handle portion 1113 and a flexible elongate member 1111. In some embodiments, the flexible elongate member 1111 may comprise a shaft, steerable tip, a steerable / active bending section and optionally an anti-prolapse passive section. The robotic gastroscope 1110 can be the same as the steerable catheter assembly as described in FIG. 10. The robotic gastroscope may be a single-use robotic endoscope. In some cases, only the catheter may be disposable. In some cases, at least a portion of the catheter may be disposable. In some cases, the entire robotic gastroscope may be released from the instrument driving mechanism and can be disposed of. In some cases, the gastroscope may contain varying levels of stiffness along its shaft, as to improve functional operation. In some cases, a minimum bend radius along the shaft may vary so that the kink resistance or anti-prolapse capability may be configurable along the length.

[0093] The robotic gastroscope can be releasably coupled to an instrument driving mechanism 1120. The instrument driving mechanism 1120 may be mounted to the arm of the robotic support system or to any actuated support system as described elsewhere herein. The instrument driving mechanism may provide mechanical and electrical interface to the robotic gastroscope 1110. The mechanical interface may allow the robotic gastroscope 1110 to be releasably coupled to the instrument driving mechanism. For instance, the handle portion of therobotic gastroscope can be attached to the instrument driving mechanism via quick install / release means, such as magnets and spring-loaded levels. In some cases, the robotic gastroscope may be coupled or released from the instrument driving mechanism manually without using a tool.

[0094] FIG. 12 and FIG. 13 show an example of an instrument driving mechanism (IDM) 1220 providing a mechanical interface to the handle portion of the robotic endoscope. In some cases, the IDM 1220 for a robotic endoscope and one or more IDMs for one or more instruments (e.g., surgical instrument) 1231, 1233 may be attached to the robotic arm 1200. As shown in the example, the instrument driving mechanism (IDM) 1220 for the robotic endoscope may comprise a set of motors 1221 that are actuated to rotationally drive a set of pull wires of the flexible endoscope or catheter. The handle portion of the catheter assembly may be mounted onto the instrument drive mechanism 1220 so that its pulley assemblies or capstans are driven by the set of motors. The number of pulleys may vary based on the pull wire configurations. In some cases, one, two, three, four, or more pull wires may be utilized for articulating the flexible endoscope or catheter. Similarly, the instrument driving mechanism (IDM) 1231 for the surgical instrument herein may comprise a set of motors 1235 that are actuated to rotationally drive a set of pull wires of the surgical instrument thereby controlling the articulation of the bending sections of the surgical instrument, the roll movement and suture operation of the needle end effector as described above.

[0095] The handle portion may be designed allowing the robotic gastroscope to be disposable at reduced cost. For instance, classic manual and robotic gastroscopes may have a cable in the proximal end of the gastroscope handle. The cable often includes illumination fibers, camera video cable, and other optional sensor fibers or cables such as electromagnetic (EM) sensors, or shape sensing fibers. Such complex cable can be expensive, adding to the cost of the gastroscope. The provided robotic gastroscope may have an optimized design such that simplified structures and components can be employed while preserving the mechanical and electrical functionalities. In some cases, the handle portion of the robotic gastroscope may employ a cable-free design while providing a mechanical / electrical interface to the catheter.

[0096] FIG. 14 shows an example of a distal tip 1400 of an endoscope. In some cases, the distal portion or tip of the endoscope 1400 may be substantially flexible such that it can be steered into one or more directions (e.g., pitch, yaw). The endoscope may comprise a tip portion, bending section, and insertion shaft. In some embodiments, the endoscope may have variable bending stiffness along the longitudinal axis direction. For instance, the endoscope may comprise multiple sections having different bending stiffness (e.g., flexible, semi-rigid, and rigid). The bending stiffness may be varied by selecting materials with different stiffness / rigidity, varyingstructures in different segments (e.g., cuts, patterns), adding additional supporting components or any combination of the above. In some embodiments, the endoscope may have variable minimum bend radius along the longitudinal axis direction. The selection of different minimum bend radius at different locations along the endoscope may beneficially provide anti-prolapse capability while still allowing the endoscope to reach hard-to-reach regions. In some cases, a proximal end of the endoscope needs not be bent to a high degree thus the proximal portion of the endoscope may be reinforced with additional mechanical structure (e.g., additional layers of materials) to achieve a greater bending stiffness. Such a design may provide support and stability to the endoscope. In some cases, the variable bending stiffness may be achieved by using different materials during extrusion of the endoscope. This may advantageously allow for different stiffness levels along the shaft of the endoscope in an extrusion manufacturing process without additional fastening or assembling of different materials.

[0097] The distal portion of the endoscope may be steered by one or more pull wires. The distal portion of the endoscope may be made of any suitable material such as co-polymers, polymers, metals or alloys such that it can be bent by the pull wires. In some embodiments, the proximal end or terminal end of one or more pull wires may be coupled to a driving mechanism (e.g., gears, pulleys, capstan etc.) via the anchoring mechanism as described above. The distal end or portion of one or more pull wires may be anchored or integrated to the distal portion of the endoscope, such that operation of the pull wires by the control unit may apply force or tension to the distal portion which may steer or articulate (e.g., up, down, pitch, yaw, or any direction inbetween) at least the distal portion (e.g., flexible section) of the endoscope.

[0098] The endoscope may have a dimension so that one or more electronic components can be integrated to the endoscope. For example, the outer diameter of the distal tip may range from 3mm to 25 mm, and the diameter of the instrument channels 1301 may range from 2 mm to 6 mm such that one or more instruments can be removably inserted through the endoscope to the surgical site. However, it should be noted that based on different applications, the outer diameter can be in any range smaller than 3 mm or greater than 25 mm, and the diameter of the instrument channels 1301 can be in any range such as about 4 mm or 5 mm to allow the surgical instrument herein passing through. The space not occupied by fluidics or instrument pass throughs can be used to embed electronic components into the wall of the endoscope.

[0099] The one or more electronic components may comprise an imaging device, illumination device or other optional sensors. In some embodiments, the imaging device may be a video camera 1313. The imaging device may comprise optical elements and image sensor for capturing image data. The image sensors may be configured to generate image data in responseto wavelengths of light. A variety of image sensors may be employed for capturing image data such as complementary metal oxide semiconductor (CMOS) or charge-coupled device (CCD). The imaging device may be a low-cost camera. In some cases, the image sensor may be provided on a circuit board. The circuit board may be an imaging printed circuit board (PCB). The PCB may comprise a plurality of electronic elements for processing the image signal. For instance, the circuit for a CCD sensor may comprise A / D converters and amplifiers to amplify and convert the analog signal provided by the CCD sensor. Optionally, the image sensor may be integrated with amplifiers and converters to convert analog signal to digital signal such that a circuit board may not be required. In some cases, the output of the image sensor or the circuit board may be image data (digital signals) can be further processed by a camera circuit or processors of the camera. In some cases, the image sensor may comprise an array of optical sensors.

[0100] The illumination device may comprise one or more light sources 1311 positioned at the distal tip. The light source may be a light-emitting diode (LED), an organic LED (OLED), a quantum dot, or any other suitable light source. In some cases, the light source may be a miniaturized LED for a compact design or Dual Tone Flash LED Lighting.

[0101] The imaging device and the illumination device may be integrated to the endoscope. For example, the distal portion of the endoscope may comprise suitable structures matching at least a dimension of the imaging device and the illumination device. The imaging device and the illumination device may be embedded into the catheter. A camera may be located at the distal portion 1400. The distal tip may have a structure to receive the camera, and illumination device. For example, the camera may be embedded into a cavity at the distal tip of the catheter. The cavity 1410 may be integrally formed with the distal portion of the cavity and may have a dimension matching a length / width of the camera such that the camera may not move relative to the endoscope. The camera may be adjacent to one or more instrument channels 1301 of the endoscope to provide near field view of the tissue or the organs. In some cases, the attitude or orientation of the imaging device may be controlled by controlling a rotational movement (e.g., roll) of the endoscope.

[0102] The power to the camera may be provided by a wired cable. In some cases, the cable wire may be in a wire bundle providing power to the camera as well as illumination elements or other circuitry at the distal tip of the endoscope. The camera and / or light source may be supplied with power from a power source located at the handle portion via wires, copper wires, or via any other suitable means running through the length of the catheter. In some cases, real-time images or video of the tissue or organ may be transmitted to an external user interface or display wirelessly. The wireless communication may be WiFi, Bluetooth, RF communicationor other forms of communication. In some cases, images or videos captured by the camera may be broadcasted to a plurality of devices or systems. In some cases, image and / or video data from the camera may be transmitted down the length of the catheter to the processors situated in the handle portion via wires, copper wires, or via any other suitable means. The image or video data may be transmitted via the wireless communication component in the handle portion to an external device / system. In some cases, the system may be designed such that no wires are visible or exposed to operators.

[0103] In conventional endoscopy, illumination light may be provided by fiber cables that transfer the light of a light source located at the proximal end of the endoscope, to the distal end of the robotic endoscope. In some embodiments of the disclosure, miniaturized LED lights may be employed and embedded into the distal portion of the catheter to reduce the design complexity. In some cases, the distal portion may comprise a structure having a dimension matching a dimension of the miniaturized LED light source. As shown in the illustrated example, two cavities may be integrally formed with the endoscope to receive two LED light sources 1311. For instance, the outer diameter of the distal tip may range from 3mm to 25 mm and diameter of the working channel of the endoscope may be around 4.5 or 6 mm such that two LED light sources may be embedded at the distal end. The outer diameter can be in any range smaller than 3 mm or greater than 25 mm, and the diameter of the instrument channels 1301 can be in any range according to the tool's dimensional or specific application. Any number of light sources may be included. The internal structure of the distal portion may be designed to fit any number of light sources.

[0104] In some cases, each of the LEDs may be connected to power wires which may run to the proximal handle. In some embodiments, the LEDs may be soldered to separated power wires that later bundle together to form a single strand. In some embodiments, the LEDs may be soldered to pull wires that supply power. In other embodiments, the LEDs may be crimped or connected directly to a single pair of power wires. In some cases, a protection layer such as a thin layer of biocompatible glue may be applied to the front surface of the LEDs to provide protection while allowing light emitted out. In some cases, an additional cover may be placed at the forwarding end face of the distal tip providing precise positioning of the LEDs as well as sufficient room for the glue. The cover may be composed of transparent material matching the refractive index of the glue so that the illumination light may not be obstructed.

[0105] The working channel (e.g., instrument channel 1301, auxiliary channel) may be designed to provide protection for the internal components such as flexible instruments (e.g., surgical instrument, forceps, etc.). When flexible instruments pass through a conventionalworking channel, they may be obstructed by the working channel due to kinking, ovalizing and / or high friction force. The working channel may provide a high hoop strength and a capability of achieving low bend radius. The working channel may also be designed to provide low friction in the inner surface. The surgical instrument as described herein may be passed through the working channel and advanced over the distal tip of the endoscope or retracted back into the working channel.

[0106] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

CLAIMSWHAT IS CLAIMED IS:

1. A surgical instrument for endoluminal operation comprising: a flexible shaft comprising an articulatable bending section; and an end effector comprising a pair of jaws located at a distal end of the bending section, wherein the end effector is switchable between a grasper mode and a suturing mode at least by changing a close angle limit of the pair of jaws.

2. The surgical instrument of claim 1, wherein the end effector comprises a drive mechanism configured to change the close angle limit of the pair of jaws when the end effector switches from the grasper mode to the suturing mode.

3. The surgical instrument of claim 2, wherein the drive mechanism comprises a pulley configured to drive a flat wire for exchanging a needle between the pair of jaws.

4. The surgical instrument of claim 3, wherein the pulley comprises a cam surface to change the close angle limit of the pair of jaws.

5. The surgical instrument of claim 4, wherein the needle is transferrable between each jaw.

6. The surgical instrument of claim 5, wherein the needle is couplable to each jaw such that it is retained by a needle coupling mechanism within the jaw.

7. The surgical instrument of claim 6, wherein the needle coupling mechanism comprises a flat wire.

8. The surgical instrument of claim 7, wherein the flat wire is controlled to engage with a relief structure of the needle at a first end and disengage with a relief structure of the needle at a second end to transfer the needle from one jaw to the other.

9. The surgical instrument of claim 7, wherein the flat wire is located within the end effector.

10. The surgical instrument of claim 1, wherein the surgical instrument is robotically controlled.

11. The surgical instrument of claim 1, wherein the surgical instrument is inserted through a first channel of an endoscopic device.

12. The surgical instrument of claim 11, wherein the surgical instrument is switched to the grasper mode when it is inserted through the first channel of the endoscopic device.

13. The surgical instrument of claim 11, wherein a needle is delivered via a delivery instrument via a second channel of the endoscopic device.

14. The surgical instrument of claim 11, wherein the needle is received by the end effector of the surgical instrument when then surgical instrument is switched to the suturing mode.

15. The surgical instrument of claim 14, wherein the end effector receives the needle by grasping the needle within a needle plane.

16. The surgical instrument of claim 14, wherein the needle passes through a hole located at each of the pair of jaws.

17. The surgical instrument of claim 1, wherein the close angle limit of the pair of jaws in the suturing mode is greater than the close angle limit in the grasper mode.

18. A method of operating a surgical instrument, the method comprising: delivering a needle to a target site using a needle delivery instrument via a first channel of an endoscopic device; inserting the surgical instrument via a second channel of the endoscopic device in a grasper mode; and switching the end effector of the surgical instrument into a suturing mode to couple the needle at the target site.

19. The method of claim 18, wherein the end effector comprises a pair of jaws.

20. The method of claim 19, wherein switching the end effector of the surgical instrument into the suturing model comprises changing a close angle limit of the pair of jaws.

21. The method of claim 19, wherein the close angle limit of the pair of jaws in the suturing mode is greater than the close angle limit in the gras per mode.

22. The method of claim 20, wherein the end effector comprises a drive mechanism configured to change the close angle limit of the pair of jaws.

23. The method of claim 18, further comprising in the suturing mode, actuating a needle coupling mechanism to exchange the needle between the jaws.

24. The method of claim 23, wherein the needle coupling mechanism is located within the end effector.

25. The method of claim 23, wherein the needle coupling mechanism comprises a flat wire actuated to engage or disengage with a relief structure of the needle.

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