Electric or manual geared suturing device

Abstract

To provide novel suturing techniques.SOLUTION: A method for operating a suturing device to be used with an endoscope, where the suturing device is configured to connect to a distal end of a shaft of the endoscope, comprises: rotating a drive shaft extending along the shaft to the suturing device; rotating a suturing element with the drive shaft; moving the suturing element to grasp a suture anchor connected to suturing material; and pulling the suturing material with the suturing element.SELECTED DRAWING: Figure 15

Description

[Technical Field]

[0001] Priority claims This patent application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 202,057 to Magno et al. (Attorney Docket No. GAP22009-GIMS-US1 / 5409.525PRV), filed May 25, 2021, and entitled "Electric or Manual Geared Suturing Device," which is incorporated herein by reference in its entirety.

[0002] SUMMARY The present disclosure generally relates to medical devices that include an elongate body configured to be inserted into an incision or opening in a patient's anatomy to provide a diagnostic or therapeutic procedure.

[0003] More particularly, the present disclosure relates to medical devices such as endoscopes, laparoscopes, and other scopes that may be inserted into a patient's anatomy with or without the aid of another device to facilitate the performance of a medical procedure, such as by cutting, cauterizing, or harvesting tissue with forceps. [Background technology]

[0004] Endoscopes can be used for one or more of: 1) providing passage of other devices, such as therapeutic or tissue-sampling devices, to various anatomical portions, and 2) imaging such anatomical portions, which may include the digestive tract (e.g., esophagus, stomach, duodenum, pancreatic bile duct, intestine, colon, etc.), renal region (e.g., kidney, ureter, bladder, urethra, etc.), other internal organs (e.g., reproductive system, sinuses, submucosal regions, airways), etc.

[0005] Conventional endoscopes may be involved in a variety of clinical procedures, including, for example, illuminating, imaging, detecting, and diagnosing one or more pathologies, providing for the delivery of fluids (e.g., saline or other formulations via fluid channels) toward an anatomical region, providing for the passage of one or more therapeutic devices (e.g., via working channels) for sampling or treating an anatomical region, and providing an aspiration passage for collecting fluids (e.g., saline or other formulations).

[0006] In traditional endoscopy, the distal portion of the endoscope may be configured to support and orient a therapeutic device using an elevator or the like. In some systems, two endoscopes can be configured to function together, with the first endoscope guiding the second endoscope inserted therein with the aid of an elevator. Such systems can be useful for guiding the endoscope to anatomical locations within the body that are difficult to reach. For example, some anatomical locations can be accessed with an endoscope only after insertion via a circuitous path.

[0007] In view of the above, medical procedures using a scope can require time and skill to deliver the desired instruments to the target anatomical structure where they are to be used. Furthermore, many decisions must be made preoperatively regarding which instruments are to be used, how the scope will be delivered to the target anatomical structure, and what procedure will be performed on the target anatomical structure once the scope is delivered. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] International Publication No. 2011 / 140118 Brochure [Patent Document 2] U.S. Patent No. 7,137,736 Summary of the Invention [Problem to be solved by the invention]

[0009] The inventors have recognized that problems to be solved with conventional medical devices used to treat and restore biological materials or perform other procedures, particularly medical scopes such as endoscopes and laparoscopes, include, among other things: 1) the difficulty of navigating the endoscope and instruments inserted therein to a location within a patient's anatomical region; 2) the difficulty of having to pre-operatively determine what instruments will be used to perform a procedure without a) seeing the actual anatomical structure and b) knowing how far the procedure has actually progressed before the scope is inserted into the anatomical structure; and 3) the increased time and associated expense associated with having to remove and re-insert instruments into the anatomical structure to perform a different procedure, such as tissue harvesting and suturing, especially when the pre-operative decision proves invalid.

[0010] The inventors have recognized that such problems may be particularly present in colonoscopy procedures, bariatric procedures, and the like. In colonoscopy procedures, a colonoscope is inserted into a patient to remove diseased tissue, such as polyps, from the colon. This typically involves removing mucosa from the surface of the digestive tract. However, occasionally, a tissue separation device, such as a forceps, may puncture the wall of the digestive tract. If the puncture is severe, it may be desirable to close the puncture, such as by suturing. However, suturing the puncture closed requires the introduction of a suturing device into the anatomical structure. Typical suturing devices involve a dedicated suturing scope or an attachment that couples to the distal end of the scope. In the latter case, it may be undesirable to attach such a device before inserting the endoscope into the anatomical structure, as such a device may be cumbersome, may make it more difficult to perform the underlying procedure, and may be unnecessary. Thus, in either case, the endoscope must be withdrawn from the patient so that the same instrument or another instrument containing the suturing attachment can be inserted back into the patient to perform the suturing. [Means for solving the problem]

[0011] The present disclosure may help provide solutions to these and other problems by providing systems, devices, and methods related to endoscopic procedures to provide: 1) a re-insertion sheath that can facilitate withdrawal of the endoscope from the anatomy and re-insertion of the endoscope into the same anatomy without the need to re-navigate the endoscope; and 2) an attachable suturing device that is a) simple to operate, b) easily navigated when attached to the scope, c) minimizes interference with the performance of the underlying endoscope, and d) can provide efficient and strong suturing.

[0012] In one example, a suturing system for coupling to a scope having a scope shaft can include a drive shaft configured to extend along the scope shaft, a mounting ring configured to mount on a distal end of the drive shaft to receive the drive shaft, a pinion gear mounted on the distal end of the drive shaft, a ring gear rotatably mounted on the mounting ring in engagement with the pinion gear, and a needle attached to the ring gear.

[0013] In another example, a method may include coupling a suturing device to a distal end portion of a shaft of an endoscope, rotating a drive shaft extending along the shaft to the suturing device, rotating a suturing element with the drive shaft, moving the suturing element to grasp a suture anchor connected to the suture material, tensioning the suture material with the suturing element, aligning tissue with the suturing element, and pushing the suture anchor and suturing element through the tissue.

[0014] In a further example, the present disclosure relates to a suturing device that can be attached to the distal end of a medical scope, such as an endoscope, that includes various imaging and guidance features. An exemplary endoscope includes a camera, a light source, and one or more working channels through which other instruments and capabilities such as irrigation or suction can be delivered. The operational aspects of such features are typically located on the distal face of the scope shaft.

[0015] In the present disclosure, a suturing device may be attached to the distal end portion of the scope shaft to provide suturing capabilities to the endoscope. The suturing device may include a shaft that can be driven from the proximal end. In some examples, the shaft may be driven by an electric motor and / or via a manually operated crank. The distal end of the shaft may be used to rotate or reciprocate a suturing element, such as via a gear system. In some examples, the shaft may include a pinion gear. A coupling element, such as a coupling ring, may be configured to attach the drive gear to the scope shaft, which provides an input to the suturing element. In some examples, the drive gear may include a ring gear having internal gear teeth configured to mate with the external gear teeth of the pinion gear. In some examples, the drive gear may include a ring gear having external gear teeth configured to mate with the external gear teeth of the pinion gear. In some examples, the drive gear may include a ring gear having internal and external gear teeth for mating with the pinion gear and offset gear. In some examples, the coupling element can include a ring configured to be centered on the distal end face of the scope shaft to mount components within the distal end face area. In some examples, the coupling element can include a ring configured to mount components within and outside the distal end face area. Thus, the shaft is rotatable via electrical or manual force to rotate a pinion gear, which in turn rotates a ring gear from which a suturing element extends for threading a suturing material.

[0016] In some examples, the suture material can be extended through a first working channel for connection to a suturing element, which can be disposed within the shaft of the endoscope or can be provided via an external element, such as a tube, extending alongside the shaft.

[0017] In some examples, a means for engaging tissue with the suturing element may be incorporated into the suturing device. In some examples, suction may be provided to draw tissue into the path of the suturing element. In some examples, suction may be provided through a second working channel connected to a suction source. In some examples, forceps may be used to force tissue into the path of the suturing element. The second working channel may be disposed within the shaft of the endoscope or may be provided via an external element, such as a tube, extending alongside the shaft.

[0018] In some examples, such as those shown with reference to FIGS. 14-23 , the suture element may comprise an arcuate needle having a sharp tip and a socket for receiving a suture anchor. In some examples, the suture anchor may comprise a ball secured or attached to the distal end of a strand of suture material. The connecting element may be configured to hold the anchor distal to the first working channel such that rotation of the suture element causes the suture element to pick up and / or drop the anchor on the connecting element. Thus, as the ring gear rotates the suture element, the tip of the suture element may be threaded through tissue while simultaneously carrying the anchor and the distal end of the suture material through the tissue from a first side of the tissue to a second side of the tissue. The suture element may be counter-rotated to withdraw the tip of the suture element from the tissue, leaving the anchor in place on the second side of the tissue. The anchor may be deployed back onto the connecting element. The suturing device may then be repositioned to a different location on the tissue, and the process may be repeated.

[0019] In some examples, the key components include a main housing, a needle ring gear, and a retaining ring, the main housing including a pinion gear connected to a flexible shaft, the rotation source being a miniature electric motor located remotely outside the length of the endoscope, the miniature electric motor housed near the endoscope's user controls, the needle ring gear being rotatable around the periphery of the main housing through an internal gear that meshes with the pinion gear, and the retaining ring holding the ring gear together with the main housing. The main housing has openings for two working channels, one opening may be for an access port for miniature forceps or vacuum tubing, and the other opening may be for a ball and suture assembly. The main housing fits snugly onto the tip of the endoscope and may have positioning features such as flats or pins to align the endoscope's working channel with the main housing working channel. The tip of the ring gear may have features for capturing the ball and suture. The ball and suture assembly may have a capture housing for the ball and suture. The ball and suture assembly can be pre-assembled to the main housing by threading it into the proximal end of the working channel of the endoscope, and once positioned externally at the distal tip, the capture housing can be fitted into the main housing working channel. [Brief explanation of the drawings]

[0020] [Figure 1] FIG. 1 is a schematic cross-sectional view of an endoscopic system including a scope, a re-insertion sheath, a tissue separation device, and a suture attachment in an exploded configuration, showing the lumens extending through the system. [Figure 2] 2 is a schematic diagram of the endoscopic system of FIG. 1 in an assembled state, showing a tissue separation device and suture attachment positioned at the distal end of the scope and a reinsertion sheath positioned around the scope. [Figure 3] FIG. 3 is a schematic diagram of an imaging and control system including a control unit connected to the scope of FIGS. 1 and 2. [Figure 4]FIG. 4 is a schematic diagram of the control unit of FIG. 3 connected to a scope. [Figure 5A] FIG. 5 is an end view of a camera module including optical and functional components suitable for use with the scope of FIGS. 1-4. [Figure 5B] 5B is a cross-sectional view taken along section 5B-5B of FIG. 5A, showing components of the camera module. [Figure 6] FIG. 1 is a schematic side view of a re-insertion sheath of the present disclosure showing a slit in the skin of the shaft. [Figure 7] 7 is a schematic cross-sectional view taken along section 7-7 of FIG. 6, showing the inner lumen of the reinsertion sheath. [Figure 8A] 7 is a schematic side view of the reinsertion sheath of FIG. 6 in a compressed state such that the skin is corrugated. [Figure 8B] 8B is a schematic side view of the reinsertion sheath of FIG. 8A in an extended state with the skin expanded. [Figure 9A] FIG. 7 is a schematic side view of the reinsertion sheath of FIG. 6 with the expandable support in a compressed state. [Figure 9B] FIG. 9B is a schematic side view of the reinsertion sheath of FIG. 9A in an extended state. [Figure 10A] 7 is a schematic side view of the reinsertion sheath of FIG. 6 with the helical support member in a compressed state. [Figure 10B] FIG. 10B is a schematic side view of the reinsertion sheath of FIG. 10A in an extended state. [Figure 11] FIG. 1 is a schematic side view of one segment of the reinsertion sheath of the present disclosure having a zipper closure mechanism. [Figure 12A] FIG. 1 is a schematic side view of one segment of the reinsertion sheath of the present disclosure having a mating rail closure mechanism. [Figure 12B] 12B is a cross-sectional view taken along section 12B-12B of FIG. 12A showing the rails of the mating rail closure mechanism. [Figure 13] 1 is a schematic diagram of a re-insertion sheath having an elongate shaft with a lumen and a gap that can be closed by magnetic force. FIG. [Figure 14]1 is a schematic diagram of an endoscope with a suturing device connected to an electric motor via a drive system comprising a gear system and a shaft. [Figure 15] FIG. 1 is an exploded view of the distal end of an endoscope and a geared suturing device having a drive shaft and pinion gear. [Figure 16] FIG. 16 is a perspective view of a ring gear having a rotating needle for coupling with the pinion gear of FIG. 15. [Figure 17] 17 is a perspective view of a retaining ring configured to hold the ring gear of FIG. 16 in engagement with the electrosuturing device of FIG. 15. FIG. [Figure 18] FIG. 17 is a perspective view of the tip of the rotating needle of FIG. 16, showing a socket for holding a suture anchor. [Figure 19] 19 is a perspective view of the tip of the rotating needle of FIG. 18, showing the suture anchor held in the socket. [Figure 20] 16 is a schematic end view of the endoscope of FIG. 15 showing a suturing device relative to a working channel of the shaft of the endoscope. [Figure 21A] FIG. 10 is a schematic view of a suturing device of the present disclosure showing the suture needle in a home position relative to the suture material channel and the suction channel. [Figure 21B] FIG. 10 is a schematic diagram of a suture needle rotated clockwise to receive an anchor from a suture channel. [Figure 21C] FIG. 10 is a schematic diagram of a suture needle rotated clockwise to pull suture material toward tissue held by a suction channel. [Figure 21D] 10 is a schematic diagram of the suture needle being rotated clockwise to push the anchor and suture needle through tissue and push the anchor back into the suture channel. FIG. [Figure 21E] FIG. 10 is a schematic diagram of a suture needle rotated counterclockwise leaving an anchor in the suture channel. [Figure 21F] FIG. 12 is a schematic diagram of a suture needle returned to a home position and a strand of suture material passing through tissue. [Figure 22]FIG. 16 is a schematic end view of a geared suturing device for use in conjunction with an external working channel, in which a pinion gear engages the outer gear teeth of a ring gear that directly drives the suturing element. [Figure 23] FIG. 10 is a schematic end view of a geared suturing device used in conjunction with an external working channel, in which a pinion gear engages the outer gear teeth of a ring gear to indirectly drive a suturing element through an offsetting gear. [Figure 24] FIG. 1 is a block diagram illustrating a method of suturing tissue using the scope, reinsertion sheath, and suturing attachment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0021] Figure 1 is a schematic diagram of an endoscopic system 100 in an exploded state. Figure 2 is a schematic diagram of the endoscopic system 100 of Figure 1 in an assembled state. Figures 1 and 2 will be discussed simultaneously. Figures 1 and 2 are not necessarily drawn to scale and may be exaggerated in some aspects for illustrative purposes.

[0022] System 100 may include a scope 102, a reinsertion sheath 104, a tissue separation device 106, and a suturing device 108. In Figure 1, scope 102, reinsertion sheath 104, tissue separation device 106, and suturing device 108 are in an assembled and disassembled configuration. In Figure 2, tissue separation device 106 and suturing device 108 are positioned at the distal end of scope 102, and reinsertion sheath 104 is positioned around scope 102.

[0023] The scope 102, which will be described in more detail with reference to Figures 3-5B, can include a shaft 110 and a control device 112, which can include a grip 114, a control knob 116, and a coupler 118. The shaft 110 can include an elongated body including a lumen 119. The coupler 118 can be connected to the control unit 16 (Figure 4) via a cable 120.

[0024] Reinsertion sheath 104 can include a shaft 122 and a lumen 124. Shaft 122 can include a slit 126 (FIG. 2) that forms flanges 128A and 128B.

[0025] The tissue separating device 106 may include a shaft 130, a tissue separator 132, and a control device 134. The tissue separator 132 may include a hinge 136 and separators 138A and 138B.

[0026] The suturing device 108 may include a coupler 140, a suturing body 142, and a control element 144. The coupler 140 may include a lumen 146.

[0027] 2 shows the scope 102 nested inside the sheath 104, the tissue separation device 106 nested inside the scope 102, and the suturing device 108 coupled to the end of the scope 102. Thus, as can be seen in FIG. 1, the reinsertion sheath 104 can include a lumen 124 and the scope 102 can include a lumen 119.

[0028] As discussed in more detail herein, the endoscopy system 100 may be configured to provide the ability to insert the scope 102, including the tissue separation device 106, into the anatomy and subsequently decide to assemble the suturing device 108 to the distal end of the scope 102. The reinsertion sheath 104 may be assembled to the shaft 110 of the scope 102 while the shaft 110 is inserted into the anatomy. The reinsertion sheath 104 may include various features to facilitate assembly with the proximal end of the shaft 110. For example, the reinsertion sheath 104 may include a slit 126 to allow the shaft 122 to be slid radially onto the shaft 110. Additionally, the reinsertion sheath 104 may include axial contraction and expansion capabilities to facilitate the assembly and insertion steps. Thus, the scope 102 may be withdrawn from the reinsertion sheath 104, assembled with the suturing device 108, and reinserted into the reinsertion sheath 104 with or without the tissue separation device 106.

[0029] Scope 102 may be configured as a fully functional endoscope, including steerability, navigation capabilities, imaging capabilities, fluid dispensing and withdrawal capabilities, and functional (e.g., therapeutic and diagnostic) capabilities, as well as a passageway for other instruments. The functionality of scope 102 is described in detail below with reference to endoscope 14 of Figures 3-5B and is therefore shown only diagrammatically in Figures 1 and 2.

[0030] Although the term "tissue separation device" is used throughout this disclosure, the tissue separation device 106 can alternatively or additionally comprise a biological material collection device, a biological material retrieval device, a tissue collection device, and a tissue retrieval device. The tissue separation device 106 can be configured as any suitable device configured to obtain, retrieve, collect, and / or remove a tissue sample from within a patient. The tissue separation device 106 can include components or devices for interacting with the patient, such as components or devices configured to cut, slice, pull, saw, punch, twist, or auger tissue or the like. Specifically, the tissue separation device 106 can include any device suitable for removing tissue from a patient, such as a blade, punch, or auger. The tissue separation device 106 can be configured to physically separate portions of the patient's tissue from other, larger portions of the patient's tissue. In a further example, the tissue separation device 106 can be configured to simply collect biological material from the patient that does not require physical separation, such as mucus or fluid that is already or naturally separated or distinct. In the example shown, tissue separating device 106 may comprise forceps having separators 138A and 138B configured as sharp or serrated jaws pivotally connected at hinge 136. However, tissue separating device 106 may be configured as a variety of devices capable of collecting biological material, such as a punch, an auger, a blade, a saw, etc., as mentioned. Tissue separating device 106 may be configured to retain a quantity of collected biological material, e.g., tissue, such as between separators 138A and 138B. Thus, tissue separating device 106 may be configured to be withdrawn from scope 102 to obtain the collected biological material, such as for diagnostic analysis or disposal.

[0031] FIG. 3 is a schematic diagram of an endoscopy system 10 comprising an imaging and control system 12 and an endoscope 14. The system of FIG. 3 is an illustrative example of an endoscopy system suitable for use with the systems, devices, and methods described herein, such as colonoscopy procedures, bariatric procedures, etc., which may be used to remove and obtain tissue or other biological material from a patient for analysis or treatment of the patient. According to some examples, the endoscope 14 may comprise the scope 102 of FIGS. 1 and 2 and may be insertable into an anatomical region for imaging and / or to facilitate the passage of one or more sampling devices for biopsies or one or more treatment devices for treatment of a medical condition associated with the anatomical region. The endoscope 14 may advantageously be in communication with and connected to the imaging and control system 12. In the example shown, the endoscope 14 comprises an end-viewing colonoscope, although other types of endoscopes may be used with the features and teachings of the present disclosure.

[0032] The imaging and control system 12 may include a control unit 16 , an output unit 18 , an input unit 20 , a light source unit 22 , a fluid source 24 , and a suction pump 26 .

[0033] The imaging and control system 12 may include various ports for coupling with the endoscopy system 10. For example, the control unit 16 may include a data input / output port for receiving data from and transmitting data to the endoscope 14. The light source unit 22 may include an output port for transmitting light to the endoscope 14, such as via a fiber optic link. The fluid source 24 may include a port for transmitting fluid to the endoscope 14. The fluid source 24 may include a pump and a tank of fluid or may be connected to an external tank, container, or storage unit. The suction pump 26 may include a port used to apply a vacuum to the endoscope 14 to generate suction, such as to draw fluid from the anatomical region into which the endoscope 14 is inserted. The output unit 18 and the input unit 20 may be used by an operator of the endoscopy system 10 to control the functions of the endoscopy system 10 and the view output of the endoscope 14. The control unit 16 may also be used to generate signals or other outputs for treating the anatomical region into which the endoscope 14 is inserted. In some examples, the control unit 16 may generate an electrical output, an acoustic output, a fluid output, etc., to treat an anatomical region by, for example, cauterizing, cutting, freezing, etc. The endoscope 14 may include an insertion section 28, a function section 30, and a handle section 32 that may be coupled to a cable section 34 and a coupler section 36. The coupler section 36 may be connected to the control unit 16 for connecting the endoscope 14 to multiple features of the control unit 16, such as the input unit 20, the light source unit 22, the fluid source 24, and the suction pump 26.

[0034] The insertion section 28 can extend distally from the handle section 32, and the cable section 34 can extend proximally from the handle section 32. The insertion section 28 can be elongated and can include a bending section and a distal end to which the functional section 30 can be attached. The bending section can be controllable (e.g., by a pull wire connected to a control knob 38 on the handle section 32) for maneuvering the distal end through a tortuous anatomical passageway (e.g., the stomach, duodenum, kidney, ureter, colon, etc.). The insertion section 28 can also include one or more working channels (e.g., internal lumens), which can be elongated and can aid in the insertion of one or more therapeutic tools of the functional section 30, such as the tissue separation device 106 of FIGS. 1 and 2. The working channels can extend between the handle section 32 and the functional section 30. Additional functionality, such as fluid passageways, guidewires, and pull wires, can also be provided by the insertion section 28 (e.g., via aspiration or irrigation passageways, etc.).

[0035] The handle section 32 can include a port 40A as well as a knob 38. The knob 38 can be coupled to a pull wire or other actuation mechanism extending through the insertion section 28. Port 40A, and other ports, such as port 40B (FIG. 2), can be configured to couple various electrical cables, guide wires, auxiliary scopes, tissue collection devices, fluid tubing, etc. to the handle section 32 for connection with the insertion section 28. For example, a tissue separation device 106 can be fed into the endoscope 14 through port 40A.

[0036] The imaging and control system 12, according to some examples, may be provided on a mobile platform (e.g., cart 41) having shelves for housing the light source unit 22, suction pump 26, image processing unit 42 (FIG. 4), etc. Alternatively, some components of the imaging and control system 12 shown in FIGS. 3 and 4 may be provided directly on the endoscope 14 to make the endoscope "self-contained."

[0037] The functional section 30 can include components for treating and diagnosing a patient's anatomy. The functional section 30 can include imaging devices, illumination devices, and elevators. The functional section 30 can include imaging and illumination components configured for end viewing, e.g., for viewing distally or axially beyond the functional section 30, as further described with reference to the camera module 70 of FIGS. 5A and 5B.

[0038] FIG. 4 is a schematic diagram of the endoscopy system 10 of FIG. 3 , including an imaging and control system 12 and an endoscope 14. FIG. 4 schematically illustrates the components of the imaging and control system 12 coupled to the endoscope 14, which in the illustrated example comprises an end-viewing colonoscope. The imaging and control system 12 can include a control unit 16, which can include or be coupled to an image processing unit 42, a treatment generator 44, and a drive unit 46, in addition to the light source unit 22, the input unit 20, and the output unit 18. A coupler section 36 can be connected to the control unit 16 for connecting the endoscope 14 to multiple features of the control unit 16, such as the image processing unit 42 and the treatment generator 44. In some examples, the port 40A can be used to insert another instrument or device, such as a daughter scope or auxiliary scope, into the endoscope 14. Such instruments and devices can be independently connected to the control unit 16 via a cable 47. In some examples, port 40B can be used to connect coupler section 36 to various inputs and outputs, such as video, air, light, and electricity. As discussed in more detail below with reference to FIGS. 14-23 , control unit 16 can include or communicate with devices for embedding or inserting suture material into tissue, such as suturing device 302 of FIG. 14 , suturing device 502 of FIGS. 15-21F , suturing device 600 of FIG. 22 , and suturing device 650 of FIG. 23 . Control unit 16 can be configured to operate a camera to view target tissue distal to endoscope 14. Similarly, control unit 16 can be configured to operate light source unit 22 to illuminate surgical instruments extending from endoscope 14.

[0039] The image processing unit 42 and the light source unit 22 can each interact with the endoscope 14 (e.g., at the function section 30) via a wired or wireless electrical connection. Thus, the imaging and control system 12 can illuminate an anatomical region, collect signals representative of the anatomical region, process the signals representative of the anatomical region, and display images representative of the anatomical region on the output unit 18, which can comprise a cathode ray tube, an LCD display, an LED display, and other graphical user interfaces. The imaging and control system 12 can include the light source unit 22 to illuminate the anatomical region with a desired spectrum of light (e.g., broadband white light, narrowband imaging using preferred electromagnetic wavelengths, etc.). The imaging and control system 12 can be connected to the endoscope 14 (e.g., via an endoscope connector) for signal transmission (e.g., light output from a light source, video signals from the imaging system at the distal end, diagnostic and sensor signals from a diagnostic device, etc.).

[0040] Fluid source 24 (FIG. 1) can be in communication with control unit 16 and can include one or more sources of air, saline, or other fluids, as well as associated fluid paths (e.g., air channels, irrigation channels, aspiration channels) and connectors (barb fittings, fluid seals, valves, etc.). Imaging and control system 12 can also include a drive unit 46, which can be an optional component. Drive unit 46 can include a motorized drive for advancing the distal section of endoscope 14, as described at least in PCT Publication No. WO 2011 / 140118 A1 to Frassica et al., entitled "Rotate-to-Advance Catheterization System," which is incorporated herein by reference in its entirety.

[0041] Figures 5A and 5B show an example of the functional section 30 of the cholangioscope 14 of Figure 4. Figure 5A shows an end view of the functional section 30, and Figure 5B shows a cross-sectional view of the functional section 30 along cross-sectional plane 5B-5B of Figure 5A. Figures 5A and 5B each show an "end-viewing endoscope" (e.g., gastroscope, colonoscope, cholangioscope, etc.) camera module 70. In the end-viewing endoscope camera module 70, the illumination system and imaging system are positioned so that the viewing angle of the imaging system corresponds to a target anatomical structure located adjacent to (e.g., distal to) the end of the endoscope 14 and is coincident with the central longitudinal axis A1 of the endoscope 14.

[0042] 5A and 5B, end-viewing endoscopic camera module 70 may include housing 72, working channel 74, fluid outlet 76, illumination lens 78, and objective lens 80. Housing 72 may include an end cap for insertion section 28, thereby providing a seal for lumen 82.

[0043] As can be seen in FIG. 5B , the insertion section 28 may include a lumen 82 through which various components may extend to connect the function section 30 to the handle section 32 ( FIG. 4 ). For example, the illumination lens 78 may be connected to a light transmitter 84, which may comprise a fiber optic cable or cable bundle extending to the light source unit 22 ( FIG. 4 ). Similarly, the objective lens 80 may be coupled to an imaging unit 87, which may be coupled to wiring 88. Additionally, the fluid outlets 76 may be coupled to a fluid line 89, which may comprise tubing extending to the fluid source 24 ( FIG. 4 ). In some examples, one of the fluid outlets 76 may include an inlet connected to a fluid line 89 configured for suction, such as being connected to a vacuum, for the collection of irrigation and flushing fluids. Other elongate elements, such as tubes, wires, and cables, may extend through lumen 82 to connect functional section 30 to components of endoscopy system 10, such as suction pump 26 (FIG. 4) and therapy generator 44 (FIG. 4). For example, working channel 74 may include a wide diameter lumen for receiving other therapeutic components, such as cutting and therapy devices, including tissue separation device 106.

[0044] Endoscopic camera module 70 may also include photosensitive elements such as a charge-coupled device ("CCD") sensor or a complementary metal-oxide semiconductor ("CMOS") sensor. In either example, imaging unit 87 may be coupled (e.g., via a wired or wireless connection) to image processing unit 42 ( FIG. 4 ) for transmitting signals (e.g., video signals) from the photosensitive elements to image processing unit 42 representing images to be displayed on a display, such as output unit 18. In various examples, imaging and control system 12 and imaging unit 87 may be configured to provide output at a desired resolution suitable for an endoscopic procedure (e.g., at least 480p, at least 720p, at least 1080p, at least 4k UHD, etc.).

[0045] As described herein, the working channel 74 may be used to deliver a tissue separation device 106 to the target tissue. Additionally, a suturing device 108 may be disposed on the distal end portion of the housing 72 to provide suturing functionality distal to the illumination lens 78 and the objective lens 80. Additionally, a re-insertion sheath 104 may be disposed about the proximal insertion section 28 of the housing 72 to allow the endoscope 14 to be inserted into and withdrawn from the anatomy with no or minimal steering and guidance.

[0046] Figure 6 is a schematic side view of the reinsertion sheath 104 of the present disclosure, showing the slit 126 in the shaft 122. Figure 7 is a schematic cross-sectional view of the reinsertion sheath 104 of Figure 6, showing the internal lumen 124 extending within the shaft 122. The shaft 122 can include the slit 126 forming flanges 128A and 128B. In some examples, the shaft 122 can further include a revolving door 148. Figures 6 and 7 will be discussed simultaneously.

[0047] The shaft 122 can extend axially along an axis A1 from a first proximal end 150 to a second distal end 152. In the example shown, the flanges 128A and 128B can form end faces separated by a distance. In other examples, the flanges 128A and 128B can contact each other to form a continuous 360-degree circumference. In some examples, a rotatable door 148 can extend from a channel in one of the flanges 128A into a channel in the other of the flanges 128B. The rotatable door 148 can be opened to allow a scope to be placed inside the lumen 124 and then rotated closed to secure the scope therein.

[0048] The lumen 124 can extend between the proximal end 150 and the distal end 152. The lumen 124 can extend in a radial direction R from the axis A1. The wall of the shaft 122 can have a thickness T. The outer diameter D1 of the shaft 122 can be configured to fit within a desired anatomy. The inner diameter D2 of the shaft 122 can be sized to fit around the shaft 110 of the scope 102 (FIGS. 1 and 2). The shaft 122 is shown as having a length L, which can be compressed and expanded as desired in various examples, as shown in FIGS. 8A and 8B. The shaft 122 is not drawn to scale in FIG. 6 and, therefore, may be longer in the direction L than shown.

[0049] Shaft 122 may be fabricated from any suitable biocompatible material. In some examples, shaft 122 may be made of a polymeric material. The material of shaft 122 may allow reinsertion sheath 104 to be deformed through manipulation by an operator, such as a surgeon. For example, an operator of reinsertion sheath 104 can pull flanges 128A and 128B apart to allow scope 102 ( FIG. 1 ) to be positioned inside lumen 124. However, reinsertion sheath 104 may be configured to maintain rigidity when positioned within the anatomy to navigate the anatomy and guide instruments through lumen 124. Thickness T may be selected to allow shaft 122 to be contracted or crumpled as shown in FIG. 8A but extended to provide a desired passageway through the anatomy. Thus, thickness T may be selected to allow an operator to manually shorten or extend length L, but shaft 122 may be configured to maintain its shape once extended.

[0050] 6 is intended to show the fully extended length of shaft 122 in a resting state where it is not subjected to any compressive or tensile load, such that outer surface 154 is approximately straight. However, shaft 122 can be subjected to a compressive force to reduce length L, as shown in FIG. 8A.

[0051] Figure 8A is a schematic side view of reinsertion sheath 104 of Figures 6 and 7 in a compressed state. Reinsertion sheath 104 can be compressed along axis A1 into the corrugated state of Figure 8A. Outer surface 154 of reinsertion sheath 104 can be compressed to form undulations 156 as the material of shaft 122 is wrinkled.

[0052] 8B is a schematic side view of reinsertion sheath 104 of FIG. 8A in an extended state along axis A1. Thus, undulations 156 can be weakened as shaft 122 is wrinkled. In some examples, reinsertion sheath 104 can be fabricated from a rigid corrugated plastic having radially extending rigid portions connected by living hinges so that the reinsertion sheath can be selectively extended and bent to desired orientations.

[0053] In some examples, the material of the shaft 122 can be flexible to allow the sheath 104 to expand and contract radially along the axis A1. The material of the shaft 122 can include a flexible polymeric sheet reinforced with webbing, such as a ripstop material. To provide radial rigidity to the sheath 104, the shaft 122 can include various stiffening means for maintaining a desired outer diameter of the sheath 104, as discussed with reference to FIGS. 9A-10B.

[0054] Figure 9A is a schematic side view of a reinsertion sheath 160 in a contracted state with an expandable support 162. Figure 9B is a schematic side view of the reinsertion sheath 160 of Figure 9A in an extended state. Figures 9A and 9B will be discussed simultaneously.

[0055] Reinsertion sheath 160 may be configured similarly to reinsertion sheath 104 of FIGS. 6-8B with the addition of cross supports or struts 164A and 164B. Reinsertion sheath 160 may include an expandable support 162 attached to a body 166, which may extend from a first end 167 to a second end 168. Expandable support 162 may include struts 164A and 164B, which may be connected at a hinge 165. A slit 169 may extend across body 166. Slit 169 is shown schematically as extending along body 166. Slit 169 may be located on body 166 opposite expandable support 162. Thus, when viewed from the end of reinsertion sheath 160, as in the view of FIG. 7, struts 164A and 164B may have a C-shape, with slit 169 forming the end of the C.

[0056] Struts 164A and 164B may comprise wires or bars embedded in or attached to the material of body 166 inside or outside of lumen 124. Struts 164A and 164B may comprise rigid or stiff members for radial and circumferential support of the material of body 166 relative to axis A1. Hinge 165 may comprise a pivot point to allow struts 164A and 164B to rotate relative to one another while maintaining contact to provide radial and circumferential support to body 166. Struts 164A and 164B may be configured to minimally affect the axial stiffness of reinsertion sheath 160.

[0057] The body 166 can include a skin over the expandable support 162 to provide a shaft structure. The skin can comprise a flexible polymeric sheet reinforced with webbing, such as a ripstop material. The body 166 can be configured to provide the desired axial stiffness to the reinsertion sheath 160.

[0058] Figure 9A shows struts 164A and 164B in a collapsed state in which the ends of struts 164A and 164B are close together, but as can be seen in Figure 9B, struts 164A and 164B can be opened by rotating at hinge 165 as reinsertion sheath 160 is expanded so that ends 167 and 168 are further apart compared to Figure 9A.

[0059] Thus, body 166 of reinsertion sheath 160 can be compressed by rotating posts 164A and 164B at hinge 165 to the state shown in FIG. 9A to facilitate assembly with the scope. When it is desired to deploy reinsertion sheath 160, the operator can pull body 166 circumferentially apart at slit 169 to allow sheath 160 to be placed over shaft 110 of scope 102. Specifically, folded reinsertion sheath 160 can be placed over the proximal end of shaft 110 while the distal end of shaft 110 is positioned within the patient's anatomy. Once placed over shaft 110, the operator can push the distal end of reinsertion sheath 160 along shaft 110 and into the patient's anatomy. As mentioned, the stiffness of body 166 can be such that an operator can unfurrow body 166 from the collapsed configuration, but as body 166 additionally increases in size, body 166 can maintain its specific shape under pressure from the anatomy. Struts 164A and 164B can provide radial stiffness to reinsertion sheath 160 to allow body 166 to resist the anatomy and to allow other devices and instruments, such as scope 102 (FIGS. 1 and 2), to be inserted therein. Thus, length L (FIG. 6) of reinsertion sheath 160 can be long enough to reach or approach the distal end of scope 102. Once reinsertion sheath 160 is deployed within the anatomy and fully extended or sufficiently extended to reach the end portion of scope 102, scope 102 can be withdrawn, and reinsertion sheath 160 can remain. Thus, inner diameter D2 (FIG. 7) can provide a body that forms a tunnel to the desired anatomy, so that scope 102 can be simply inserted into re-insertion sheath 160 to reach the desired anatomy without having to be independently navigated to the original anatomy.Thus, the scope 102 can be withdrawn from the anatomical structure through the reinsertion sheath 160 to attach one of the suturing devices described herein with reference to Figures 14-23, and then reinserted with the suturing device to reach the same anatomical structure.

[0060] Figure 10A is a schematic side view of a reinsertion sheath 170 in a contracted state, having a helical support member 172. Figure 10B is a schematic side view of the reinsertion sheath 170 of Figure 10A in an extended state. Figures 10A and 10B will be discussed simultaneously.

[0061] Reinsertion sheath 170 can include a body 176 extending between ends 177 and 178. A slit 179 can extend along body 176. Reinsertion sheath 170 can be configured similar to reinsertion sheath 160 of FIGS. 9A and 9B, with expandable support 162 replaced by a helical support member 172. Helical support member 172 can include a rigid or stiff member that spirals along reinsertion sheath 170 between ends 177 and 178.

[0062] Slit 179 can extend across body 176. Slit 179 is shown schematically as extending along body 176. Slit 179 can be located on body 176 opposite helical support member 172. Thus, when viewed from the end of reinsertion sheath 170, as in the view of FIG. 7, helical support member 172 can have a C-shape, with slit 169 forming the end of the C. Thus, helical support member 172 may not form a continuous helical shape between ends 177 and 178, but can be formed of multiple helical segments.

[0063] 9A and 9B, helical support member 172 can provide radial and circumferential stiffening to body 176 to provide support against anatomical pressures and to form a body that defines a tunnel for insertion of instruments. However, helical support member 172 can allow for axial expansion and contraction of body 176 such that the natural stiffness of body 176 can be utilized to allow axial contraction and expansion of reinsertion sheath 170 to enable deployment as described with reference to FIGS.

[0064] FIG. 11 is a schematic side view of a segment of a reinsertion sheath 180 of the present disclosure having a zipper closure mechanism 182. The sheath 180 can include a shaft 184 and a slit 185. The shaft can extend from a first side 187A to a second side 187B. The zipper closure mechanism 182 can include opposed teeth 186A and 186B on either side of the slit 185 and a shuttle 188. The zipper closure mechanism 182 is not necessarily drawn to scale in FIG. 11. The reinsertion sheath 180 of FIG. 11 can be used in conjunction with any of the reinsertion sheaths described herein, such as reinsertion sheaths 104, 160, and 170. The zipper closure mechanism 182 can be configured to extend along any of the slits 126, 169, and 179.

[0065] Teeth 186A may be disposed along one side of slit 185. Teeth 186B may be disposed along a second side of slit 185. Teeth 186A and 186B may be staggered such that teeth 186A can fit between teeth 186B, and vice versa. Shuttle 188 may be used to engage and disengage teeth 186A and 186B. Thus, zipper closure mechanism 182 may function as a zipper in a conventional manner.

[0066] The zipper closure mechanism 182 can be released to allow the teeth 186A and 186B to separate. Thus, the reinsertion sheath 180 can be placed around the shaft of the scope. The reinsertion sheath 180 can be inserted into the anatomy with the first side 187A positioned distally so that it enters the anatomy first. As the shaft 184 is pushed or fed distally into the anatomy, the shuttle 188 can be pulled proximally to engage the teeth 186A and 186B. Thus, as the shaft 184 is expanded and fed further into the anatomy, the shuttle 188 can be advanced to close the shaft 184.

[0067] FIG. 12A is a schematic side view of a segment of a reinsertion sheath 190 of the present disclosure having a mating rail closure mechanism 191. The reinsertion sheath 190 can include a shaft 192 and a slit 193. The shaft 192 can extend from a first end 194A to a second end 194B. The mating rail closure mechanism 191 can include a first rail 195A and a second rail 195B. The mating rail closure mechanism 191 is not necessarily drawn to scale in FIG. 12A . The reinsertion sheath 190 of FIG. 12A can be used in conjunction with any of the reinsertion sheaths described herein, such as the reinsertion sheaths 104, 160, and 170 described herein. The mating rail closure mechanism 191 can be configured to extend along any of the slits 126, 169, and 179.

[0068] The first rail 195A and the second rail 195B may be mounted on the ends of the shaft 192 forming the slit 193 in an overlapping manner, as described with reference to FIG.

[0069] 12B is a cross-sectional view of the reinsertion sheath closure mechanism 191 of FIG. 12A. The mating rail closure mechanism 191 can include a first rail 195A and a second rail 195B. The first rail 195A can include a first protrusion 196A and a first slot 197A. The second rail 195B can include a second protrusion 196B and a second slot 197B. The protrusions 196A and 196B can include spherical heads, and each rail of the slots 197A and 197B can include inwardly oriented teeth configured to engage with the spherical heads. In one example, the mating rail closure mechanism 191 can be configured in accordance with U.S. Patent No. 7,137,736 to Pawloski et al., which is incorporated herein by reference in its entirety.

[0070] As shown in FIG. 12B , the ends of slit 193 can be pulled such that portions of shaft 192 overlap to allow slots 197A and 197B and protrusions 196A and 196B, respectively, to interact. Protrusion 196A and slot 197A can be placed in an overlapping configuration and compressed together by an operator to lock. Similarly, protrusion 196B and slot 197B can be placed in an overlapping configuration and compressed together by an operator to lock. In one example, a shuttle can be provided on mating rail closure mechanism 191 to facilitate compressing protrusions 196A and 196B with slots 197A and 197B and separating the aforementioned components. Either end 194A or 194B can be fed into the anatomy first.

[0071] FIG. 13 is a schematic diagram of the reinsertion sheath 104, which includes an elongated body 176 with a lumen 124 and a slit 126. The slit 126 can include a plurality of magnetic members 198 and a metallic strip 199. The magnetic members 198 can be attracted to the metallic strip 199 via magnetic force. Thus, in a quiescent state, the magnetic members 198 can pull the end of the elongated body 176 along the closed slit 126. However, the magnetic members 198 can be pushed away from the metallic strip 199 to allow a device or object to radially enter the lumen 124. After the device or object enters the lumen 124, the magnetic members 198 can be pulled back to engage with the metallic strip 199 via magnetic attraction. Thus, the sheath 104 can be easily slid over the shaft 110 of the scope 102 while the scope 102 is inserted into the anatomy.

[0072] 6-13 illustrate examples of reinsertion sheaths of the present disclosure having various features that can be used together, separately, or in various combinations. The reinsertion sheath of the present disclosure can provide a body that forms a tunnel through an anatomical structure, which can guide another instrument inserted therein to a desired location. The reinsertion sheath can be placed within the anatomical structure using another instrument that has previously been guided (e.g., steered, pivoted, controlled, and manipulated to be pushed through desired anatomical features and conduits) to a target tissue site within the anatomical structure. Thus, the previously inserted instrument can function as a type of guiding feature, similar to a guidewire, to direct the reinsertion sheath to the target tissue site without actively guiding the reinsertion sheath or with minimal manipulation or cajoling. As discussed herein, the reinsertion sheath can be circumferentially openable to allow placement of the reinsertion sheath over the instrument radially relative to the axis of the instrument. Thus, the reinsertion sheath can be placed over the proximal end of the instrument while the distal end is positioned within the anatomical structure. The reinsertion sheath material can form a skin radially reinforced with wires or bars that is axially compressible, e.g., axially contracted or collapsed, to fit over only a portion of the instrument's length, e.g., the portion of the instrument not inserted into the anatomy. Thus, the reinsertion sheath can be more easily manipulated. Once positioned over the proximal portion of the inserted instrument, the reinsertion sheath can be expanded or unfolded to compress the distal portion of the reinsertion sheath into the patient's anatomy around the instrument. Axially collapsible support features can be used to provide radial rigidity to the reinsertion sheath to push the anatomy away from the central axis of the reinsertion sheath. Thus, when the guide instrument is removed from the reinsertion sheath, an open tunnel can be provided within the reinsertion sheath to provide a direct route to the target tissue site.

[0073] 14 is a schematic diagram of an endoscope 300 including a suturing device 302 connected to an electric motor 304 via a drive system 306 including a gear system 308 and a shaft 310. The endoscope 300 may further include a tissue engagement device 311 that may be used to hold tissue for the suturing device 302.

[0074] In some examples, endoscope 300 may include a two-channel endoscope having internal channels for shaft 310 and tissue engagement device 311. As shown in Figures 22 and 23, either or both of shaft 310 and tissue engagement device 311 may be introduced through an external working channel that runs parallel to endoscope 300. In some examples, a separate external working channel is provided for housing a capture mechanism that facilitates pulling suture material from a proximal location, and the center of rotation for gear system 308 may be off-centered on endoscope 300 to allow the suturing element to pick up fasteners from the external working channel.

[0075] The endoscope 300 can be configured according to any of the scopes described herein. The endoscope 300 can include a shaft 312 and a controller 314. The controller 314 can be configured to operate the features of the endoscope 300, as well as the motor 304, the suturing device 302, and the tissue engagement device 311. The shaft 312 of the endoscope 300, shown cut away in FIG. 14, can extend along an axis A4.

[0076] The motor 304 may be coupled to the endoscope 300, such as at the controller 314. The motor 304 may include an electric motor configured to receive power from the controller 314 or an external power source. In some examples, the motor 304 may include a miniature electric motor. In further examples, the motor 304 may include or replace a manual input, such as a crank handle or knob, to allow a user of the endoscope 300 to impart rotation to the shaft 310 with mechanical advantage. For example, the shaft 310 may be mechanically actuated utilizing a push / pull mechanism including a corkscrew-style rotational path. The gear system 308 may be connected to the suturing device 302. The gear system 308 may comprise part of the suturing device 302 or may be a separate, connectable component. The shaft 310, shown cut away in FIG. 14, may extend along the shaft 312 of the endoscope 300 along axis A5. In the example shown, the shaft 310 may be attached to the exterior of the shaft 312. In other examples, shaft 310 can extend through shaft 312. In either configuration, axis A5 can be parallel to axis A4. However, in other examples, shaft 310 can be non-parallel to shaft 312.

[0077] The suturing device 302 can comprise a device for implanting or applying suture material to tissue. For example, the suturing device 302 can include a device for advancing a suturing element, such as a needle, to extend one or more strands of suture material through tissue, such as by pulling the suture material back. The suturing device 302 can utilize the rotational output of the motor 304, transmitted through the shaft 310 and the gear system 308, to advance the suturing element. The gear system 308 can convert the rotational output of the shaft 310 into an input suitable for use with the suturing device 302. In some examples, the gear system 308 can include a spur gear system, a herringbone gear system, a bevel gear system, a worm gear system, a rack-and-pinion gear system, or an internal gear system. In some examples, the gear system 308 can include the gear systems of FIGS. 22 and 23, which can enable off-axis suturing. The gear system 308 can be used to generate circular or reciprocating motion of the suturing element to push or pull the suture material through tissue. For example, the suturing element can be driven circumferentially about axis A4 or along another axis parallel to axis A4. In some examples, the suturing element can be reciprocated in the same circumferential direction. In other examples, the suturing element can be reciprocated along axis A4 or another axis parallel to axis A4. Reciprocating motion can be generated by reversing the direction of rotation of shaft 310 or through the use of mechanisms such as crankshafts and orbital couplings that can convert a unidirectional rotational input into a bidirectional output.

[0078] The tissue engagement device 311 may comprise a device that can draw tissue toward the suturing device 302 and hold the tissue in place to allow the suturing element to be placed at a precise location through the tissue. The tissue engagement device 311 of the endoscope 300, shown cut away in FIG. 14 , may extend along axis A6. In some examples, the tissue engagement device 311 may comprise a tube to allow another device, such as forceps, to pass through the tissue engagement device 311. In some examples, the tissue engagement device 311 may comprise a suction tube through which a vacuum may be drawn to pull the tissue toward the suturing device 302. The tissue engagement device 311 may allow for the insertion of an instrument or suction tube, or connection to a suction source via insertion or connection through the control unit 314 or directly.

[0079] In some examples, the suturing device 302 and tissue engagement device 311 may comprise one or more attachments that may be coupled to a conventional endoscope. Additionally, the suturing device 302 and tissue engagement device 311 may be incorporated into the endoscope such that they cannot be removed by the user. In various examples, the suturing device 302 may be used in conjunction with the endoscope to eliminate the need to use an additional, dedicated suturing device. Similarly, the suturing device 302 may be used without the tissue engagement device 311 if the endoscope 300 includes a working channel that can accept, for example, forceps or a suction tube.

[0080] FIG. 15 is an exploded view of an endoscope 500 and a geared suturing device 502 having a drive shaft 504 and a pinion gear 505. The drive shaft 504 may be connected to a motor 503. The endoscope 500 may be configurable according to any of the scopes described herein. As discussed herein, the suturing device 502 may include a device for moving a suturing element, such as a needle, staple, shuttle, or the like, to pull and / or push suture material through tissue. In some examples, an electric motor 503 may be used to move an arcuate or helical suture needle via a geared connection. While the suturing device 502 is described as a device that can be detachably attached to the endoscope 500, in further examples, the suturing device 502 or components thereof (e.g., the attachment ring 524, the drive shaft 504, and the socket 538) may be incorporated directly into the endoscope 500.

[0081] Endoscope 500 can include a shaft 506 having an end face 508, which can include a working channel 510 and a suturing channel 512, as well as various other components, including an imaging lens 514, an illumination lens 516, an irrigation channel 518, auxiliary channels 519A and 519B, and other components typically used in endoscopes. An instrument 520 can be placed within working channel 510 or auxiliary channels 519A and 519B to perform a medical intervention. In the example shown, auxiliary instrument 520 can include a vacuum tube, although in other examples, it can include forceps. A suture tube 522 can comprise a device for providing suture material to suturing device 502.

[0082] The suturing device 502 can include a mounting ring 524 to which the pinion gear 505 can be attached. The mounting ring 524 can comprise a main housing to which other components of the suturing device 502 can be attached. The mounting ring 524 can include an axial extension 525 projecting forward of the end face 508. The axial extension 525 can include a seat 530 extending around the outer diameter surface. The seat 530 can comprise a surface to which a retaining ring 570 ( FIG. 17 ) can be attached. In some examples, the seat 530 can be recessed radially inwardly in the outer diameter surface of the mounting ring 524 so that a shoulder 532 can be formed. The mounting ring 524 can include a socket 534 for receiving the drive shaft 504. The socket 534 can retain the pinion gear 505 axially distal to the seat 530. The mounting ring 524 can further include an end plate 533, an outlet 536, an opening 537, and a socket 538. Opening 537 may provide access to features on end face 508 of endoscope 500 through mounting ring 524. Exit 536 may allow working channel 510 access distal to mounting ring 524. Socket 538 may include a receiver for receiving suture tube 522. End plate 533 may hold exit 536 and socket 538 in a fixed relationship. Socket 538 may be attached to end plate 533 to extend distally of mounting ring 524 so as to be positioned distal to and within the field of view of imaging lens 514 and illumination lens 516.

[0083] The mounting ring 524 can comprise a rigid or flexible body that facilitates coupling with the shaft 506. The mounting ring 524 can be sized to fit around the end face 508 of the endoscope 500. The mounting ring 524 can comprise an annular body having a sidewall 526 that passes from one end to the other along the axis A7. The shaft 506 can extend along the axis A7. The shaft 506 of the endoscope 500 can be sized to fit within the sidewall 526 in a concentric manner to retain the suturing device 502 attached to the endoscope 500. The mounting ring 524 can be coupled to the shaft 506 via an interference fit, a threaded connection, or other suitable means. For example, the sidewall 526 of the ring 524 can be threadably engaged with the outer surface 528 of the shaft 506. In some examples, an interference fit can be formed between the sidewall 526 and the shaft 506. Sidewall 526 may extend straight to the proximal end of mounting ring 524 and may include an end plate 533 to prevent mounting ring 524 from being pushed proximally along shaft 506. Such an end plate may ensure proper alignment of outlet 536 and socket 538 relative to end face 508 to ensure suture tube 522 is within the field of view of imaging lens 514 and illumination lens 516. However, sidewall 526 may allow enough end face 508 to be exposed without interfering with working channel 510, suture channel 512, imaging lens 514, illumination lens 516, and irrigation channel 518. Thus, mounting ring 524 may form a cap that may be releasably attached to shaft 506. The sidewall 526 and shaft 506 may further include features (not visible in FIG. 15 ) to facilitate rotational alignment between the suturing device 502 and the endoscope 500, such as to provide proper orientation between the working channel 510, suturing channel 512, imaging lens 514, illumination lens 516, and irrigation channel 518 of the endoscope 500 and the sidewall 526 of the mounting ring 524.In some examples, the rotational alignment feature can comprise an axially extending channel extending into end face 508 at a particular circumferential location that can receive a corresponding axially extending flange on side wall 526, or vice versa. In some examples, side wall 526 of mounting ring 524 can have a positioning feature, such as a flat surface that mates with a corresponding flat surface on shaft 506, for example, to align suture channel 512 of endoscope 500 with socket 538 of mounting ring 524.

[0084] The suture tube 522 may comprise a tube 540 having a suture strand 542, a stopper 544, and a holder 546 disposed therein. The tube 540 may comprise an elongate body having an internal lumen extending from the distal end face 508 to the proximal end of the endoscope 500. The tube 540 may allow a supply of suture material to be connected to the end face 508. Accordingly, the proximal end of the suture strand 542 may be wound on a spool such that the supply of suture material is provided to the suturing device 502. The distal end of the suture strand 542 may be connected to a stopper or anchor 544. The stopper 544 may comprise a ball or another shaped body that provides a mechanism for engaging the suturing device 502 and may also lock the suture strand 542, preventing it from passing through fibers in tissue, for example. The stopper 544 may be attached to the suture strand 542 via any suitable mechanism, such as by being threaded through a hole in the stopper 544, or the stopper 544 may be crimped onto the suture strand 542. The holder 546 may include a body for holding the stopper 544 to enable engagement with the suturing device 502, which may be configured to pull the suture strand 542 from the tube 540.

[0085] The holder 546 can be molded similarly to the socket 538, and the holder 546 can be sized to fit within the socket 538. The holder 546 and socket 538 can be configured to hold the stopper 544 in a specific position relative to the mounting ring 524 to allow the suturing device 502 to engage the stopper 544 and the suture strand 542. The holder 546 and socket 538 can provide an open passageway axially to allow suture material to extend therethrough. The holder 546 and socket 538 can include radial openings to allow the suturing device 502 to pass radially through the holder 546 and socket 538. For example, the socket 538 can include an upper portion 548A and a lower portion 548B. Similarly, the holder 546 can include an upper portion 549A and a lower portion 549B. The socket 538 and holder 546 can allow the stopper 544 to be securely seated within the suturing device 502, but also allow a suturing element, for example, the needle 552 of FIG. 16, to push and / or pull the stopper 544 from the socket 538 and holder 546. In some examples, the upper and lower portions 548A, 548B can be deflectable in a radially outward direction to facilitate insertion and removal of the stopper 544.

[0086] FIG. 16 is a perspective view of a ring gear 550 having a rotating needle 552 for coupling with the pinion gear 505 of FIG. 15 . The ring gear 550 can comprise a component of the suturing device 502. The ring gear 550 can comprise a ring body 554, a flange 556, gear teeth 558, and a needle 552. The needle 552 can comprise a needle body 560 and a needle tip 562. The gear teeth 558 can be configured to engage with the pinion gear 505. The ring gear 550 can be configured to be disposed axially distal of the mounting ring 524 such that the radially outwardly pointing gear teeth of the pinion gear 505 engage with the gear teeth 558 and the flange 556 engages with the distal tip of the pinion gear 505. Thus, the pinion gear 505 can move the ring gear 550 to rotate about axis A7. 17, a retaining ring 570 may be used to support the ring gear 550. The ring gear 550 may be made of a rigid material, such as stainless steel, to allow for secure engagement of the gear teeth 558.

[0087] The needle body 560 can comprise a curved body having a first end coupled to the ring body 554 and a second end attached to the needle tip 562. In some examples, the needle body 560 can comprise an arcuate segment having a smaller radius of curvature than the ring body 554. In some examples, the needle body 560 can comprise a curved body extending along a non-circular path. The needle body 560 can be configured to position the needle tip 562 for engagement with the socket 538. In some examples, in addition to being circumferentially curved about the axis A7, the needle body 560 can extend along a helical or corkscrew-shaped path such that the distance D4 can exceed the distance D3 as the needle body 560 extends axially along the axis A7. The needle body 560 can be made of a rigid material, such as stainless steel, to enable the needle tip 562 to be passed through tissue. The needle body 560 can be integral with the ring body 554.

[0088] FIG. 17 is a perspective view of a retaining ring 570 configured to hold the ring gear 550 of FIG. 16 engaged with the mounting ring 524 of FIG. 15 . The retaining ring 570 may comprise a component of the suturing device 502. The retaining ring 570 may comprise a ring body 572 and a flange 574. The ring body 572 of the retaining ring 570 may fit over the ring body 554 of the ring gear 550 and extend onto the mounting ring 524. The flange 574 may extend radially inward and abut against the flange 556 to capture the ring gear 550 between the mounting ring 524. The ring body 572 may fit over the mounting ring 524 via an interference fit and allow the ring gear 550 to rotate freely between the mounting ring 524 and the retaining ring 570. The retaining ring 570 may be made of a rigid material, such as stainless steel, or a resilient material, such as plastic or rubber.

[0089] Figure 18 is a perspective view of the tip 562 of the rotary needle 552 of Figure 16, showing the socket 580 for holding the stopper 544. Figure 19 is a perspective view of the tip 562 of the rotary needle 552 of Figure 18, showing the stopper 544 held in the socket 580. Figures 18 and 19 will be discussed simultaneously.

[0090] The socket 580 can include a cylindrical body 582, a suture guide 584, and a blade 586. The cylindrical body 582 can include components for attachment to the needle body 560. The cylindrical body 582 can include a partial or complete ring or another shaped body for coupling to the needle body 560. In some examples, the cylindrical body 582 can be attached to the needle body 560 via an interference fit. The suture guide 584 can include a component or device for receiving the suture strand 542. The suture guide 584 can include a first arm 588A, a second arm 588B, and a notch 590. The suture guide 584 can be configured to allow the stopper 544 to be received within the socket 580 without interference from the suture strand 542. The blade 586 can include a body configured to pierce tissue. Blade 586 can include a curved wall 592 and a cutting edge 594. Curved wall 592 can be configured to hold stopper 544 against suture guide 584 while simultaneously positioning cutting edge 594 distal to stopper 544. Edges 596A and 596B of curved wall 592 can be angled from cutting edge 594 to suture guide 584. Edges 596A and 596B can be sharpened to facilitate cutting into tissue.

[0091] So configured, socket 580 can be configured to retain stopper 544 while needle 552 is rotated. For example, socket 580 can be shaped to receive or retain stopper 544 when needle 552 is moved clockwise with reference to FIG. 16 toward stopper 544, but allow stopper 544 to be removed from socket 580 when needle 552 is moved counterclockwise with reference to FIG. 16 away from stopper 544. In some examples, tension on suture strand 542 can facilitate retention of stopper 544 within socket 580.

[0092] FIG. 20 is a schematic end view of the endoscope 500 of FIG. 15 , showing the suturing device 502 relative to the working channel 510 and suturing channel 512 of the shaft 506 of the endoscope 500. The needle 552 may be configured to rotate about the axis A7 of the shaft 506. The needle body 560 may be curved and may coil toward the axis A7. The base 507 of the needle body 560 may be connected to the ring gear 550 at the outer diameter of the ring body 554 ( FIG. 16 ), while the cutting edge 594 may be disposed inward of the ring body 554 to provide the needle body 560 with a smaller radius of curvature than the ring body 554. The cutting edge 594 of the needle 552 may be disposed a distance D5 from the axis A7. The center of the suturing channel 512 may be disposed a distance D6 from the axis A7. Distance D5 may be approximately equal to distance D6 so that rotation of needle 552 allows socket 580 to engage stopper 544 exiting suture channel 512, such as via suture tube 522 (FIG. 15).

[0093] Various principles of operation of the presently disclosed rotationally driven suturing device, and in particular suturing device 502 of FIGS. 15-20, are described as follows with reference to FIGS. 21A-21F.

[0094] FIG. 21A is a schematic diagram of a suturing device 502 of the present disclosure showing a suture needle 552 in a home position relative to a suture channel 512 and a working channel 510. FIG. 21A may correspond to a first step or operation of a method for embedding suture material in tissue using a geared suturing mechanism. In the home position of FIG. 21A , the suture needle 552 may be positioned such that the cutting edge 594 is positioned away from the suture channel 512. The suture needle 552 may be positioned so as not to block or interfere with the suture channel 512 and the working channel 510. In the example shown, the cutting edge 594 is positioned approximately 180 degrees away from and above the suture channel 512. Thus, for discussion purposes, the cutting edge 594 may be considered to be at the 12 o'clock position, and the stopper 544 may be held at the 6 o'clock position by the socket 538.

[0095] The stopper 544 can be retained in a socket 538 between the upper portion 548A and the lower portion 548B. The socket 538 can retain the stopper 544 in the path of the cutting edge 594. The socket 538 can be configured to allow the needle body 560 to pass between the upper portion 548A and the lower portion 548B. For example, the left side of the upper portion 548A can be spaced a distance D7 from the left side of the lower portion 548B, and the right side of the upper portion 548A can be spaced a distance D7 from the right side of the lower portion 548B, thereby allowing the cutting edge 594 to pass between the upper portion 548A and the lower portion 548B, in part because the cutting edge 594 is axially spaced from the base 597 of the needle body 560. In some examples, the distances D7 and D8 can be equal. However, in other examples, distances D7 and D8 may be different to facilitate insertion and removal of stopper 544 from socket 538 in only one direction. In the example shown, distance D7 may be greater than distance D8. Thus, cutting edge 594 can enter socket 538 on the right side without stopper 544 in a clockwise motion to remove stopper 544 from socket 538 on the left side of socket 538, or can enter socket 538 on the right side with stopper 544 in a clockwise motion via deflection of portions 548A and 548B to place stopper 544 in socket 538. Also, in such a configuration, cutting edge 594 can enter socket 538 from the left with stopper 544 to place stopper 544 in socket 538, as portions 548A and 548B grip stopper 544 from cutting edge 594.

[0096] FIG. 21B is a schematic diagram of the suture needle 552 rotated clockwise to receive the stopper 544 from the suture channel 512. FIG. 21B shows the suture needle 552 in a pick-up position. FIG. 21B may correspond to a second step or operation of a method for embedding suture material in tissue using a geared suturing mechanism. In the pick-up position of FIG. 21B, the suture needle 552 can be positioned such that the cutting edge 594 is disposed in the suture channel 512. The suture needle 552 can extend across the working channel 510. In the example shown, the cutting edge 594 is disposed in the suture channel 512. Therefore, for purposes of discussion, the cutting edge 594 can be considered to be at the 6 o'clock position where the socket 580 can pick up the stopper 544. The needle body 560 can be rotated clockwise by the motor 503 to move the cutting edge 594 into the socket 538. Socket 580 (FIG. 18) of needle 552 can receive stop 544 from socket 538. Needle 552 can continue to rotate and stop near the 11-12 o'clock position, as shown in FIG. 21C.

[0097] FIG. 21C is a schematic illustration of the suture needle 552 rotated clockwise to pull the suture strand 542 toward the tissue 598 held by the suction channel 510. FIG. 21C shows the suture needle 552 in a parked position. FIG. 21C may correspond to a third step or operation of a method for embedding suture material in tissue using a geared suturing mechanism. In the parked position of FIG. 21C, the suture needle 552 may include a stopper 544 and may be positioned such that the cutting edge 594 and stopper 544 may be positioned away from the suture channel 512 and the working channel 510. Thus, for discussion purposes, the cutting edge 594 and stopper 544 may be considered to be in the 12 o'clock position. The needle body 560 may be rotated clockwise by the motor 503 to move the cutting edge 594 out of the socket 538. A socket 580 (FIG. 18) in the needle 552 can release the stopper 544 from the socket 538. The stopper 544 can pull on the suture strand 542, which can be aligned with a suture guide 584 (FIG. 18).

[0098] The working channel 510 may be used to facilitate interaction with the tissue 598. For example, forceps may extend from the working channel 510 to grasp the tissue 598. In a further example, suction may be applied from the working channel 510, either directly from the working channel 510 or via a suction tube extending into the working channel 510. The forceps or suction may be used to pick up the tissue 598 or pull the tissue 598 near the endoscope 500. Specifically, the forceps or suction may hold the tissue 598 within the path of the suture needle 552. The forceps or suction may hold the tissue 598 in the 3 o'clock position.

[0099] FIG. 21D is a schematic illustration of the suture needle 552 rotated clockwise to force the stopper 544 and cutting edge 594 through the tissue 598 and push the stopper 544 up the suture channel 512. FIG. 21D shows the suture needle 552 in a suturing position. FIG. 21D may correspond to a fourth step or operation of a method for embedding suture material in tissue using a geared suturing mechanism. In the suturing position of FIG. 21D , the needle body 560 can be rotated clockwise by the motor 503 to move the cutting edge 594 and stopper 544 through the tissue 598. In the example shown, the suture needle 552 can be advanced through the tissue 598 such that the cutting edge 594 and stopper 544 return to the suture channel 512, and for discussion purposes, the cutting edge 594 and stopper 544 can be considered to be in the six o'clock position.

[0100] FIG. 21E is a schematic illustration of the suture needle rotated counterclockwise, leaving the anchor back in the suture channel. FIG. 21E shows the suture needle 552 in a home position. FIG. 21E may correspond to a fifth step or operation of a method for embedding suture material in tissue using a geared suturing mechanism. FIG. 21E shows the needle 552 positioned back in the home position with one loop of suture thread 542 extending through tissue 598. From the position of FIG. 21D, the needle 552 can be rotated counterclockwise to leave the stopper 544 in the socket 538 with the suture thread 542 extending therefrom. In the home position, the needle 552 is again ready to perform another cycle of suturing in the tissue 598.

[0101] FIG. 21F is a schematic diagram of the suture needle returned to the home position and the strand of suture material penetrating the tissue. FIG. 21F shows the suture needle 552 in the home position. FIG. 21F may correspond to a sixth step or operation of a method for embedding suture material in tissue using a geared suturing mechanism. FIG. 21F shows the needle 552 positioned to repeat steps 1-5 with the strand of suture strand 542 already in place. The endoscope 500 can be moved to position the suturing device 502 at a different location on the tissue 598. Thus, the suction or forceps from the working channel 510 can be released. The suturing device 502 can be repositioned along the tissue 598 via operator action. The tissue 598 can be reacquired by the forceps or suction from the working channel 510. The needle 552 can then be rotated clockwise by the motor 503 to re-acquire the stopper 544, push the stopper 544 through the tissue 598, and re-seat the stopper 544 in the socket 538 after forming a second loop of the suture thread 542.

[0102] Terminating the suture may be accomplished through the user's technique of looping the ball and suture at the last thread to create a knot. The mini-forceps may have cutting blades for cutting the suture.

[0103] FIG. 22 is a schematic end view of a geared suturing device 600 used in conjunction with an external working channel 602. The geared suturing device 600 can include a pinion gear 604 that engages the external gear teeth of a ring gear 606, which directly drives a suturing element 608. The geared suturing device 600 can be used with a scope 610, which can include a shaft 612, a working channel 614, a suturing channel 616, an imaging lens 618, and a light source 620. FIG. 22 shows the pinion gear 604 directly driving the ring gear 606 via the external teeth of the ring gear 606. The suturing element 608 can include a needle, such as needle 552, and can be attached directly to the ring gear 606. However, the center of rotation of the ring gear 606 can be offset from the center of the shaft 612 of the scope 610 to allow the suturing element to pass in front of the external working channel 602. The mounting ring 524 (FIG. 15) may include laterally (e.g., radially) protruding flanges or features to support the ring gear 606. In the example of FIG. 22, the external working channel 602 may be used similarly to the working channel 510 of FIGS. 21A-21F or the suture channel 512 of FIGS. 21A-21F.

[0104] 23 is a schematic end view of a geared suturing device 650 used in conjunction with an external working channel 652. The geared suturing device 650 can include a pinion gear 654, a ring gear 656, and an offsetting gear 657. The geared suturing device 650 can be used with a scope 660, which can include a shaft 662, a working channel 664, a suturing channel 666, an imaging lens 668, and a light emitter 670. The outer gear teeth of the pinion gear 654 can drive the outer gear teeth of the ring gear 656 to indirectly drive the suturing element 658 through the offsetting gear 657. The inner gear teeth of the ring gear 656 can drive the outer gear teeth of the offsetting gear 657 to rotate the suturing element 658.

[0105] 22 and 23 may allow the attachment of the presently disclosed suturing device to be attached to an existing endoscope without requiring the use of two working channels within the endoscope. Thus, a single working channel scope may be used, or a second working channel within the endoscope may be used to perform procedures other than suturing.

[0106] The suturing devices of the present disclosure may have many benefits, for example, they may be simple and intuitive, may achieve full-thickness tissue closure (e.g., greater than 2 cm), may be easily attached to and compatible with any endoscope, may have ease of use (e.g., circular needles with robust electric or manual needle drive mechanisms), may reduce procedure time, may be low cost (e.g., less than $1,000), and may be mechanically robust.

[0107] 24 is a block diagram illustrating a method 400 of suturing tissue using the scope, reinsertion sheath, and suturing attachment of the present disclosure. Method 400 may involve the use of any of the devices described herein, such as the scope 102, reinsertion sheath 104, tissue separation device 106, and suturing device 108 of FIGS. 1 and 2, as well as the devices of FIGS. 14-23.

[0108] In step 402, a patient may be evaluated for the performance of a medical procedure. In one example, it may be determined pre-operatively that the patient's colon needs to be treated with a tissue harvesting device, such as tissue separation device 106 (FIG. 1). The treatment may include removal of diseased or other tissue. It may be determined pre-operatively that tissue can be harvested without having to incise, cut, or puncture the patient's duct wall. Thus, it may be determined pre-operatively that the procedure will not involve suturing. Thus, pre-operative planning may not involve attaching a suturing device, such as suturing device 108 (FIG. 1), to a scope used to perform the procedure, such as scope 102 (FIG. 1).

[0109] In step 404, the scope may be navigated through the anatomical structure to the target tissue. An access portal or incision may be made in the patient's anatomy. In some examples, the scope 102 (FIG. 1) may be inserted into the patient and navigated to the colon. The steering and navigation features of the scope 102 may be used to guide the distal end of the scope 102 to the target tissue. For example, the imaging capabilities may be used to visualize the anatomical structure, including the intersection of anatomical conduits. The steering capabilities may be used to pivot the distal end of the scope 102 into the desired conduit and the target tissue within the desired conduit.

[0110] In step 406, a portion of the medical procedure may be performed. For example, a portion of the procedure pre-operatively planned in step 402 may be performed. Target tissue may be harvested using the tissue separation device 106. The target tissue may include tissue that may be diseased or that represents a pathological condition in the patient. For example, the separators 138A and 138B may be operated from the control device 134 to engage the target tissue one or more times to harvest, separate, and, if necessary, store the target tissue.

[0111] In step 408, the procedure being performed may be evaluated. For example, the total amount of tissue harvested may be evaluated to ensure a sufficient amount has been harvested. The patient may also be evaluated to determine whether all of the diseased tissue has been harvested. During the evaluation procedure, the patient's anatomical structure may be reexamined to determine whether bleeding has occurred. If bleeding has occurred, it may be determined that a vessel wall of the anatomical structure has been punctured. Therefore, it may be determined that the incision in the patient should be closed, such as with a suturing device. Therefore, it may be determined that the scope 102 should be withdrawn from the anatomical structure to facilitate insertion of the suturing device.

[0112] In step 410, a reinsertion sheath may be applied to scope 102 while it remains inserted within the patient's anatomy. As discussed herein, reinsertion sheath 104 may be manipulated to enlarge slit 126, such as by circumferentially separating the end faces of flanges 128A and 128B (FIG. 7). Accordingly, reinsertion sheath 104 may be moved radially over the proximal portion of shaft 110 (FIG. 2) of endoscope 102. Reinsertion sheath 104 may be relaxed to allow the end faces of flanges 128A and 128B to be brought closer together. Additionally, reinsertion sheath 104 may be axially expanded for insertion into the anatomy. For example, reinsertion sheath 104 may be shifted from the compressed configuration of FIG. 8A to the expanded configuration of FIG. 8B to allow one of ends 150 or 152 (FIG. 6) to be slid along scope 102 to reach the target anatomy. The reinsertion sheath 104 can be gently guided along the shaft 110 to avoid interfering with adjacent anatomical structures or features of the scope 102. An axial closure mechanism, such as a zipper closure mechanism 182 (FIG. 11) or a mating rail closure mechanism 191 (FIGS. 12A and 12B), can be used to close the slit 126. The axial closure mechanism can be used before or during axial deployment of the reinsertion sheath.

[0113] In step 412, the scope may be withdrawn from the reinsertion sheath. For example, the scope 102 may be withdrawn from the anatomy through the reinsertion sheath 104. The reinsertion sheath 104 may remain within the anatomy to radially open and hold a passageway or tunnel to the target anatomy.

[0114] In step 414, an attachment may be coupled to the withdrawn scope. The attachment that was determined to be used in step 408 may be assembled to the scope. For example, a suturing device 108 may be attached to the shaft 110 of the scope 102. Referring to FIG. 15 , a mounting ring 524 may be placed around the distal end face 508 of the shaft 506 of the endoscope 500.

[0115] The scope, along with the attachment device, may be inserted into the reinsertion sheath in step 416. The scope 102, including the suturing device 108, may be slid into the lumen 124 (FIG. 1) of the reinsertion sheath 104.

[0116] In step 418, the scope may be pushed into the reinsertion sheath to reach the target anatomy. The scope 102 may be inserted until the distal end face and suturing device 108 reach the target anatomy at the distal end of the reinsertion sheath 104.

[0117] In step 420, the attachment device assembled to the scope in step 414 may be deployed for use. For example, holder 546 may be locked into socket 538 to position stopper 544 for use. Additionally, instrument 520 may be positioned within exit port 536 for use. Accordingly, suturing device 502 may be sized or shaped to have a smaller footprint in the pre-deployment stage to allow easier insertion of scope 102 through reinsertion sheath 104. However, suturing device 502 may be configured for use in the deployed position, such as by extending instrumentation and components to engage suturing device 502.

[0118] In step 422, another portion of the surgical procedure planned in step 402 and evaluated in step 408 may be performed. For example, the suturing device 108 may be used to close the incision and stop bleeding. Any of the various motor-driven suturing elements described herein may be actuated to provide motive force to the suturing element to drive it. Additionally, the tissue separating device 106 may be used with the scope 102 to remove additional tissue from the anatomical structure. The tissue separating device 106 may be inserted into the lumen 119 ( FIG. 1 ) and extended out the distal end of the shaft 110 while the suturing device 108 is attached to the shaft 110. Thus, separators 138A and 138B may be positioned proximal to the suturing device for use.

[0119] Method 400 can then return to step 412 to remove the scope and attachment device and reinsert the scope with a different reattachment device, if desired, or can continue to step 424 to complete the procedure.

[0120] In step 424, the reinsertion sheath may be removed from the scope. For example, the reinsertion sheath 104 may be slid proximally along the shaft 110 of the scope 102 until it is removed from the anatomy. The reinsertion sheath 104 may be opened at the slit 126 so that it can be pulled away from the scope 102.

[0121] In step 426, the scope may be removed from the anatomy. For example, the scope 102 may be withdrawn from the anatomy. Alternatively, the reinsertion sheath 104 and the scope 102 may be removed together, or the scope 102 may be removed first and the reinsertion sheath 104 may be removed second. The access portal within the patient may then be closed appropriately.

[0122] Thus, method 400 illustrates an example of a method for performing a medical procedure using a scope that can be withdrawn from and reinserted into a patient's anatomy via an intraoperative reinsertion sheath that can be positioned around the in situ scope. The scope can be withdrawn intraoperatively to perform an adjunctive procedure, such as suturing an intraoperatively determined incision, with the attachment of an auxiliary device, such as a suturing device disclosed herein. Preoperative planning can thus be simplified, as the need to a priori decide whether or not to use an auxiliary device, such as a suture attachment, can be postponed to an intraoperative decision. Intraoperative procedure changes can be facilitated by the use of a reinsertion sheath that can be placed around the shaft of a scope already placed within the patient's anatomy, such as through the use of an axially extending slit extending along the reinsertion sheath. Intraoperative procedure changes can be facilitated by the use of a suturing device that can be easily and securely attached to the scope and changed from a retracted position, which facilitates scope navigation, to a deployed position, which facilitates use of the suturing device with the scope. Thus, the devices and methods described herein can facilitate medical procedures and promote better patient outcomes.

[0123] Various notes and examples Example 1 is a suturing system for connecting to a scope having a scope shaft, the suturing system comprising: a drive shaft configured to extend along the scope shaft; an attachment ring configured to be attached to the distal end of the scope shaft to receive the drive shaft; a pinion gear attached to the distal end of the drive shaft; a ring gear engaged with the pinion gear and rotatably attached to the attachment ring; and a needle attached to the ring gear.

[0124] In Example 2, the subject matter described in Example 1 optionally includes an electric motor connected to a proximal end of the drive shaft.

[0125] In Example 3, the subject matter of any one or more of Examples 1-2 optionally includes a hand crank connected to a proximal end of the drive shaft.

[0126] In Example 4, the subject matter of any one or more of Examples 1-3 optionally includes a scope shaft, the scope shaft comprising a first working channel.

[0127] In Example 5, the subject matter described in Example 4 optionally includes a suction device connected to the first working channel.

[0128] In Example 6, the subject matter of any one or more of Examples 4-5 optionally includes a forceps disposed within the first working channel.

[0129] In Example 7, the subject matter described in any one or more of Examples 4-6 optionally includes a second working channel extending through the scope shaft, wherein the drive shaft extends through the second working channel.

[0130] In Example 8, the subject matter described in Example 7 optionally includes the pinion gear being mounted within a mounting ring.

[0131] In Example 9, the subject matter described in any one or more of Examples 5-8 optionally includes a tube defining a second working channel for the drive shaft, the tube extending parallel to the exterior of the scope shaft.

[0132] In Example 10, the subject matter of any one or more of Examples 8-9 optionally includes the pinion gear being mounted on the outside of the mounting ring.

[0133] In Example 11, the subject matter described in any one or more of Examples 4-10 optionally includes, wherein the mounting ring further comprises an end plate having an opening configured to align with the first working channel to rotationally align the scope shaft and the mounting ring.

[0134] In Example 12, the subject matter of any one or more of Examples 1-11 optionally includes, wherein the attachment ring comprises an anchor catch configured to receive an anchor from the working channel.

[0135] In Example 13, the subject matter described in Example 12 optionally includes the anchor catch comprising a cylindrical body having upper and lower portions configured to hold the anchor, with a pathway for the needle disposed between the upper and lower portions.

[0136] In Example 14, the subject matter of any one or more of Examples 12-13 optionally includes, wherein the needle comprises an anchor socket configured to receive the anchor from the anchor catch.

[0137] In Example 15, the subject matter described in Example 14 optionally includes, wherein the needle comprises a curved needle body extending from the ring gear toward the center of the scope shaft so as to align with the anchor catch.

[0138] In Example 16, the subject matter of any one or more of Examples 14-15 optionally includes a suture tube extendable from the scope shaft.

[0139] In Example 17, the subject matter described in Example 16 optionally includes a suture anchor configured to be received within the anchor catch and anchor socket, the suture anchor being connected to a strand of suture material extending from the suture tube.

[0140] In Example 18, the subject matter described in Example 17 optionally includes wherein the suture anchor comprises a sphere.

[0141] In Example 19, the subject matter of any one or more of Examples 16-18 optionally includes, wherein the suture tube comprises an anchor holder configured to be inserted into the anchor catch.

[0142] In Example 20, the subject matter of any one or more of Examples 1-19 optionally includes a retaining ring for retaining the ring gear with the mounting ring, the mounting ring including a seat on which the mounting ring is mounted to capture the ring gear between the retaining ring and the mounting ring.

[0143] Example 21 is a method including the steps of coupling a suturing device to a distal end portion of a shaft of an endoscope, rotating a drive shaft extending along the shaft to the suturing device, rotating a suturing element with the drive shaft, moving the suturing element to grasp a suture anchor connected to suture material, pulling the suture material with the suturing element, aligning tissue with the suturing element, and pushing the suture anchor and suture material through the tissue.

[0144] In Example 22, the subject matter described in Example 21 optionally includes rotating the drive shaft with an electric motor.

[0145] In Example 23, the subject matter of any one or more of Examples 21-22 optionally includes rotating the drive shaft with a hand crank.

[0146] In Example 24, the subject matter of any one or more of Examples 21-23 optionally includes aligning the tissue with the suturing element via suction.

[0147] In Example 25, the subject matter of any one or more of Examples 21-24 optionally includes aligning the tissue with the suturing element via forceps.

[0148] In Example 26, the subject matter described in any one or more of Examples 21-25 optionally includes rotating a ring gear in which the suturing element is centrally mounted on a distal end face of the shaft.

[0149] In Example 27, the subject matter described in any one or more of Examples 21-26 optionally includes a step of rotating a ring gear to which the suturing element is mounted off-center on the distal end face of the shaft.

[0150] In Example 28, the subject matter of any one or more of Examples 21-27 optionally includes rotating the suturing element with a pinion gear attached to the drive shaft.

[0151] In Example 29, the subject matter of any one or more of Examples 21-28 optionally includes rotating the suturing element with an offsetting gear driven by a drive shaft.

[0152] In Example 30, the subject matter described in any one or more of Examples 1-29 optionally includes reciprocating the suturing element with a drive shaft while moving the suturing device along the tissue.

[0153] In Example 31, the subject matter of any one or more of Examples 21-30 optionally includes the step of pulling the suture material from the shaft of the endoscope.

[0154] In Example 32, the subject matter of any one or more of Examples 21-31 optionally includes pulling the suture material through the shaft of the endoscope parallel to the shaft.

[0155] In Example 33, the subject matter described in any one or more of Examples 21-32 optionally includes a step of retaining the suture anchor in a receiver of a suturing device and a step of removing the suture anchor from the receiver by a socket in the suturing element.

[0156] In Example 34, the subject matter of any one or more of Examples 21-33 optionally includes rotating the suturing element from a home position in a first direction to initiate the suturing process.

[0157] In Example 35, the subject matter described in Example 34 optionally includes rotating the suturing element in a first direction to pick up the suture anchor from a socket of a suturing device attached to the shaft.

[0158] In Example 36, the subject matter described in Example 35 optionally includes rotating the suturing element in a first direction to tension the suture material.

[0159] In Example 37, the subject matter described in Example 36 optionally includes the steps of moving the endoscope to a first position on the tissue and rotating the suturing element in a first direction to push the suture anchor through the first position on the tissue.

[0160] In Example 38, the subject matter described in Example 37 optionally includes the step of placing a suture anchor within the socket.

[0161] In Example 39, the subject matter described in Example 38 optionally includes a step of rotating the suturing element in a second direction opposite to the first direction to withdraw the suturing element from the tissue while leaving the suture anchor in the socket.

[0162] In Example 40, the subject matter described in Example 39 optionally includes the step of moving the endoscope to a second position on the tissue and re-engaging the suturing element to push the suture anchor through to the second position.

[0163] Example 41 is a system for endoscopic suturing, comprising: a scope shaft having a proximal end portion and a distal end face; an electric motor connected to the scope shaft at the proximal end portion; a drive shaft extending from the electric motor to a position proximal to the distal end face; a suturing element movably mounted on the scope shaft for movement distal to the distal end face; and a gear system connecting the drive shaft and the suturing element, wherein the gear system is configured to convert rotational movement of the drive shaft into a suturing stroke of the suturing element.

[0164] Each of these non-limiting examples can stand alone or can be combined in various permutations or combinations with one or more of the other examples.

[0165] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as "examples." Such examples may include elements in addition to those shown or described. However, the inventors also contemplate examples in which only those elements shown or described are provided. Furthermore, the inventors contemplate the use of any combination or permutation of the illustrated or described elements (or one or more aspects thereof) with a particular example (or one or more aspects thereof) or other examples (or one or more aspects thereof) shown or described herein.

[0166] If there is a conflicting usage between this document and any document incorporated by reference, the usage in this document will control.

[0167] In this document, the terms "a" or "an" are used to include one or more, regardless of any other examples or the use of "at least one" or "one or more," as is common in patent documents. In this document, the term "or" is used to mean a nonexclusive or, unless otherwise indicated, such that "A or B" includes "A excluding B," "B excluding A," and "A and B." In this document, the terms "including" and "in which" are used as the plain-English equivalents of the respective terms "comprising" and "wherein." Also, in the following claims, the terms "including" and "comprising" are open-ended, i.e., systems, devices, articles, compositions, formulations, or processes that include elements in addition to those recited after such terms in a claim are still construed as falling within the scope of that claim. Moreover, in the following claims, the terms "first," "second," and "third," etc., are used merely as labels and are not intended to impose numerical requirements on their objects.

[0168] The example methods described herein may be at least partially machine- or computer-implemented. Some examples may include a computer-readable or machine-readable medium encoded with instructions operable to configure an electronic device to perform a method such as described in the above examples. An implementation of such a method may include code such as microcode, assembly language code, high-level language code, etc. Such code may include computer-readable instructions for performing various methods. The code may form part of a computer program product. Further, in one example, the code may be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media, such as during execution or at other times. Examples of such tangible computer-readable media may include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or memory sticks, random access memory (RAM), read-only memory (ROM), etc.

[0169] The above description is intended to be illustrative and not limiting. For example, the above examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments may be employed by those of ordinary skill in the art upon review of the above description. The Abstract is provided to comply with 37 CFR §1.72(b) to enable the reader to quickly ascertain the nature of the technical disclosure. The Abstract is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be construed as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may not include all features of a particular disclosed embodiment. Accordingly, the following claims are incorporated into the Detailed Description herein as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is intended that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. [Explanation of symbols]

[0170] 10 Endoscopy System 12 Imaging and Control System 14 Endoscopy, Cholangioscopy 16 Control Unit 18 Output Units 20 input units 22 Light source unit 24 Fluid source 26 Suction pump 28 Insert Section 30 Function Section 32 Handle Section 34 Cable Section 36 Coupler Section 38 Control knob, knob 40A port 40B port 41 Cart 42 Image Processing Unit 44 Treatment Generator 46 Drive Unit 47 Cable 70 Camera Module, Endoscope Camera Module, End Viewing Endoscope Camera Module 72 Housing 74 Working Channel 76 Fluid outlet 78 Lighting Lens 80 objective lenses 82 Lumen 84 Light transmitter 87 Imaging unit 88 Wiring 89 Fluid Line 100 Endoscope system, endoscopy system 102 Scopes, endoscopes 104 Reinsertion Sheath 106 Tissue Separation Device 108 Suture Device 110 Shaft 112 Control device 114 Grip 116 Control Knob 118 Coupler 119 Lumen 120 Cable 122 Shaft 124 Lumen 126 Slit 128A flange 128B flange 130 shaft 132 Tissue Separator 134 Control Devices 136 Hinge 138A Separator 138B Separator 140 Coupler 142 Sutured Body 144 Control Elements 146 Lumen 148 Revolving door, revolving door 150 proximal end 152 distal end 154 Outer surface 156 undulations 160 Reinsertion Sheath 162 Expandable Support 164A Post 164B Post 165 hinge 166 Body 167 First End 168 Second End 169 Slit 170 Reinsertion Sheath 172 Spiral support member 176 body, long body 177 End 178 End 179 Slit 180 Reinsertion Sheath 182 Zipper Closure Mechanism 184 shaft 185 slit 186A Teeth 186B Teeth 187A First Side 187B Second Side 188 Shuttle 190 Reinsertion Sheath 191 Interlocking rail closure mechanism, reinsertion sheath closure mechanism 192 shaft 193 Slit 194A First End 194B Second end 195A First Rail 195B Second Rail 196A First protrusion 196B Second protrusion 197A 1st slot 197B Second Slot 198 Magnetic Components 199 Metal Strips 300 Endoscope 302 Suture Device 304 Electric motors, motors 306 Drive System 308 Gear System 310 Shaft 311 Tissue Engaging Devices 312 Shaft 314 Control Device 400 ways 402 Step 404 Step 406 Steps 408 Steps 410 steps 412 steps 414 steps 416 steps 418 steps 420 steps 422 steps 424 steps 426 steps 500 Endoscopes 502 Suture Device 503 Motors, electric motors 504 Drive shaft 505 pinion gear 506 Shaft 507 Base 508 End face 510 Working Channel 512 Suture Channel 514 Imaging Lens 516 Lighting Lens 518 Irrigation Channel 519A Auxiliary Channel 519B Auxiliary Channel 520 Equipment 522 Suture Tube 524 Mounting ring 525 Axial extension 526 Side wall 528 Outer surface 530 Seat 532 Shoulder 533 End plate 534 sockets 536 Exit 537 Opening 538 sockets 540 tubes 542 Suture thread 544 Stopper 546 Holder 548A Upper part 548B Lower part 549A Upper part 549B lower part 550 ring gear 552 needles, rotating needles 554 Ring Body 556 flange 558 gear teeth 560 needle body 562 Needle Tip 570 Retaining Ring 572 Ring Body 574 flange 580 socket 582 Cylindrical Body 584 Suture Guide 586 blades 588A First Arm 588B Second Arm 590 Notch 592 Curved Wall 594 Cutting edge 596A Edge 596B Edge 597 Base 598 Organization 600 Suturing device, geared suture device 602 External Working Channel 604 Pinion gear 606 Ring Gear 608 Suture element 610 Scope 612 Shaft 614 Working Channel 616 Suture Channel 618 Imaging Lens 620 Luminous Object 650 Suturing device, geared suture device 652 External Working Channel 654 Pinion gear 656 Ring Gear 657 Offsetting Gear 658 Suture elements 660 Scope 662 Shaft 664 Working Channel 666 Suture Channel 668 Imaging Lens 670 Luminous Object A1 central longitudinal axis, axis A2 axis A3 axis A4 axis A5 axis A6 axis A7 axis D1 Outer diameter D2 inner diameter D3 Distance D4 Distance D5 distance D6 distance D7 distance D8 distance L length, direction R Radial direction T Thickness

Claims

1. 1. A method for operating a suturing device for use with an endoscope, the suturing device being configured to be connected to a distal end portion of a shaft of the endoscope; The method comprises: rotating a drive shaft extending along the shaft to the suturing device; rotating a suturing element with the drive shaft; moving the suturing element to grasp a suture anchor connected to suture material; tensioning the suture material with the suturing element; A method comprising:

2. The method of claim 1 , further comprising rotating the drive shaft with an electric motor.

3. The method of claim 1 further comprising rotating the drive shaft with a hand crank.

4. The method of claim 1, further comprising aligning a target to be sutured with the suturing element via suction.

5. The method of claim 1, further comprising aligning a target to be sutured with the suturing element via forceps.

6. The method of claim 1, further comprising the step of rotating a ring gear centrally mounted on the distal end face of the shaft, the suturing element.

7. The method of claim 1, further comprising rotating a ring gear on which the suturing element is mounted off-center on a distal end face of the shaft.

8. The method of claim 1, further comprising rotating the suturing element with a pinion gear attached to the drive shaft.

9. The method of claim 1, further comprising rotating the suturing element with an offsetting gear driven by the drive shaft.

10. The method of claim 1, further comprising the step of reciprocating the suturing element with the drive shaft while moving the suturing device along a target to be sutured.

11. The method of claim 1, further comprising the step of pulling the suture material from the shaft of the endoscope.

12. The method of claim 1, further comprising the step of pulling the suture material parallel to and from the shaft of the endoscope.

13. retaining the suture anchor within a receiver of the suturing device; removing the suture anchor from the receiver by means of a socket in the suturing element; The method of claim 1 further comprising:

14. The method of claim 13, further comprising rotating the suturing element in a first direction from a home position to initiate a suturing process.

15. The method of claim 14, further comprising rotating the suturing element in the first direction to pick up the suture anchor from a socket of the suturing device attached to the shaft.

16. The method of claim 14, further comprising rotating the suturing element in the first direction to tension the suture material.

17. moving the endoscope to a first position over a target to be sutured; rotating the suturing element in the first direction to push the suture anchor through the first location on the target; 17. The method of claim 16, further comprising:

18. The method of claim 17, further comprising the step of placing the suture anchor within the socket.

19. 19. The method of claim 18, further comprising rotating the suturing element in a second direction opposite the first direction such that the suturing element can be withdrawn from the target while the suture anchor remains in the socket.

20. 20. The method of claim 19, further comprising the steps of moving the endoscope to a second position on the target and re-engaging the suturing element to push the suture anchor through the second position.

21. 1. A method for operating a suturing device for use with an endoscope, comprising: rotating a drive shaft extending along the endoscope shaft; rotating a pinion gear attached to a distal end of the drive shaft via the drive shaft; rotating a ring gear rotatably mounted to a distal portion of the suturing device via the pinion gear and engaging the pinion gear; moving a needle attached to the ring gear; A method comprising:

22. 22. The method of claim 21, further comprising moving the needle along a helical path.

23. 1. A method for assembling a suturing device for use with an endoscope, comprising: providing a drive shaft extending along the endoscope shaft; engaging a pinion gear with a distal end of the drive shaft; engaging a ring gear with the pinion gear, the ring gear being rotatably mounted to a distal portion of the suturing device; attaching a needle to the ring gear; A method comprising:

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