An endoscope including a reinsertion sheath and a suturing device

Abstract

A method for withdrawing an endoscope from an anatomical structure includes inserting an endoscope into the anatomical structure to deliver a distal end of the endoscope to a location, placing a guide sheath around a proximal end of the endoscope, sliding the guide sheath along the endoscope to reach the distal end, and withdrawing the guide sheath and the endoscope from the anatomical structure. A system for intraoperatively attaching a suturing device to an in situ endoscope includes an insertion sheath having an elongated tunnel body extending between a proximal end and a distal end and a slit extending axially along the elongated tunnel body, and a suturing device releasably coupleable to the endoscope. A re-insertion sheath for an endoscope includes an elongated body having proximal and distal ends and a skin extending axially between the proximal and distal ends, and a slit extending along the shaft to allow circumferential expansion of the elongated body.

Description

Technical Field

[0001] Claims of Priority This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 155,072, filed Mar. 1, 2021, and U.S. Provisional Patent Application No. 63 / 216,633, filed Jun. 30, 2021, which are hereby incorporated by reference in their entirety.

[0002] The present disclosure generally relates to medical devices having an elongate body configured to be inserted into an incision or opening in a patient's anatomical structure to provide a diagnostic or therapeutic action.

[0003] More particularly, the present disclosure relates to medical devices such as endoscopes, laparoscopes, and other scopes that can be inserted into a patient's anatomical structure with or without the aid of another device to facilitate the performance of medical procedures such as cutting, cauterizing, or taking tissue samples using forceps.

Background Art

[0004] Endoscopes can be used for one or more of: 1) enabling passage to various anatomical parts of other devices such as, for example, a treatment device or a tissue sampling device; and 2) imaging such anatomical parts. Such anatomical parts can include the gastrointestinal tract (e.g., esophagus, stomach, duodenum, pancreaticobiliary duct, intestine, colon, etc.), the renal region (e.g., kidneys, ureters, bladder, urethra, etc.), other internal organs (e.g., genital system, sinuses, submucosal region, airways), etc.

[0005] Conventional endoscopes can be involved in various clinical procedures, such as illuminating, imaging, detecting, and diagnosing one or more pathological conditions, delivering fluids (e.g., physiological saline or a formulation through a fluid channel) to an anatomical region, enabling the passage of one or more treatment devices (e.g., through a working channel) for sampling or treating the anatomical region, and providing a suction passage for collecting fluids (e.g., physiological saline or other formulations).

[0006] In conventional endoscopy, the distal portion of the endoscope can be configured to support and orient a treatment device using an applicator or the like. In some systems, it is possible to configure two endoscopes to function together, where the first endoscope guides the second endoscope inserted therein with the aid of an applicator. Such a system can be useful for guiding the endoscope to anatomical locations within the body that are difficult to reach. For example, some anatomical locations can only be accessed using an endoscope after insertion via a circuitous route.

[0007] Considering the above, medical procedures using a scope can require time and skill to deliver the desired instrument to the target anatomical structure where the instrument is to be used. Further, many decisions have to be made preoperatively regarding which instrument is to be used, how the scope is to be delivered to the target anatomical structure, and what procedure is to be performed on the target anatomical structure when the scope is delivered.

Prior Art Documents

Patent Documents

[0008]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0009] Among the problems to be solved associated with conventional medical devices used for treating and rehabilitating biological substances or performing other procedures, particularly medical scopes such as endoscopes and laparoscopes, are, inter alia: 1) the difficulty of guiding an endoscope and the instruments inserted therein to a position within the anatomical region of a patient; 2) the difficulty of determining preoperatively which instruments are to be used to perform a procedure without a) viewing the actual anatomical structure and b) knowing to what extent the procedure is actually progressing before the scope is inserted into the anatomical structure; and 3) the increased time and associated costs involved in having to remove and reinsert instruments into the anatomical structure to perform different procedures such as tissue sampling and suturing, particularly when it is found that a preoperative determination is invalid. The inventors have recognized these problems.

[0010] The inventors have recognized that such problems can particularly exist in colonoscopy procedures, obesity treatments, and the like. In a colonoscopy procedure, a colonoscope is inserted into a patient to remove diseased tissue such as polyps from the colon. This typically involves removing the mucosa from the surface of the gastrointestinal tract. However, occasionally, a tissue separation device, such as forceps, may penetrate the wall of the gastrointestinal tract. If the penetration is serious, it may be desirable to close the penetration by suturing or the like. However, closing the penetration by suturing requires the introduction of a suturing device into the anatomical structure. A typical suturing device involves a dedicated suturing scope or an attachment that couples to the distal end of the scope. In the latter case, it may not be desirable to attach those devices before inserting the endoscope into the anatomical structure, as such devices can be difficult to handle, may make it more difficult to perform the underlying procedure, and may not be needed. Thus, in either case, the endoscope must be withdrawn from the patient so that the same instrument including the suturing attachment or a different instrument can be inserted back into the patient to perform the suturing. Means for Solving the Problems

[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 anatomical structure and re-insertion of the endoscope into the same anatomical structure without the need to re-steer the endoscope; and 2) an attachable suturing device that is a) simple to operate, b) easily guided 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 method of withdrawing an endoscope from a target location within an anatomical structure may include inserting an endoscope into an access portal within the anatomical structure to deliver a distal end portion of the endoscope to the target location, positioning a guide sheath around a proximal end portion of the endoscope, sliding the guide sheath along the endoscope to reach the distal end portion, and withdrawing the endoscope from the guide sheath and the anatomical structure.

[0013] In another example, a system for attaching a suturing device to an in situ endoscope during surgery may include an insertion sheath having an elongated tunnel body extending from a proximal end portion to a distal end portion and a slit extending axially along the elongated tunnel body, and a suturing device that is releasably coupleable to the endoscope.

[0014] In one example, a reinsertion sheath for an endoscope may include an elongate body having a proximal end portion, a distal end portion, and a skin extending axially between the proximal and distal end portions, and a slit extending along the shaft to allow circumferential expansion of the elongate body.

[0015] In another example, an electromagnetically driven suturing device may include a body, a first coil embedded in the body, and a suturing element configured to be actuated by a magnetic field generated in the first coil.

[0016] In another example, the electromagnetic sewing device may comprise a C-shaped housing having a first arm with a first end face, a first sewing track extending into the first end face, a second arm having a second end face at least partially facing the first end face, a second sewing track extending into the second end face, a first coil embedded in the first arm, and a sewing element configured to be driven by a magnetic field generated by the first coil to move from the first sewing track to the second sewing track.

[0017] In one example, the electromagnetic hammer sewing device may comprise a housing, a first coil embedded in the housing, a first shuttle configured to reciprocate within the housing by a magnetic field generated by the first coil, and a sewing element configured to be actuated by the first shuttle.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0019] FIG. 1 is a schematic view of the endoscope system 100 in a disassembled state. FIG. 2 is a schematic view of the endoscope system 100 of FIG. 1 in an assembled state. FIGS. 1 and 2 are discussed simultaneously. FIGS. 1 and 2 are not necessarily drawn to a fixed scale and may be exaggerated in some aspects for illustrative purposes.

[0020] The system 100 may include a scope 102, a reinsertion sheath 104, a tissue separation device 106, and a suturing device 108. In FIG. 1, the scope 102, the reinsertion sheath 104, the tissue separation device 106, and the suturing attachment 108 are in a disassembled and assembled configuration. In FIG. 2, the tissue separation device 106 and the suturing attachment 108 are disposed at the distal end of the scope 102, and the reinsertion sheath 104 is disposed around the scope 102.

[0021] The scope 102, which will be described in more detail with reference to FIGS. 3-5B, can include a long body 110 and a control device 112, and the control device 112 can include a grip 114, a control knob 116, and a connector 118. The long body 110 can include a lumen 119. The connector 118 can be connected to a control unit 16 (FIG. 4) via a cable 120.

[0022] The reinsertion sheath 104 can include a shaft 122 and a lumen 124. The shaft 122 can include a slit 126 (FIG. 2) that forms flanges 128A and 128B.

[0023] The tissue separation device 106 can include a shaft 130, a tissue separator 132, and a control device 134. The tissue separator 132 can include a hinge 136, and separators 138A and 138B.

[0024] The suturing device 108 can include a coupler 140, a suture body 142, and a control element 144. The coupler 140 can include a lumen 146.

[0025] FIG. 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.

[0026] As discussed in more detail herein, the endoscopic system 100 can be configured to provide the ability to insert a scope 102 that includes a tissue separation device 106 into an anatomical structure and subsequently make a determination to assemble a suturing device 108 to the distal end of the scope 102. The reinsertion sheath 104 can be assembled to the shaft 110 of the scope 102 while the shaft 110 is inserted into the anatomical structure. The reinsertion sheath 104 can include various features to facilitate assembly with the proximal end of the shaft 110. For example, the reinsertion sheath 104 can include a slit 126 to allow the shaft 122 to be slid radially onto the shaft 110. Additionally, the reinsertion sheath 104 can include axial contraction and expansion capabilities to facilitate the assembly and insertion steps. Thus, the scope 102 can 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.

[0027] The scope 102 can be configured as a fully functional endoscope that includes not only a passage for other instruments, but also steerability, guidance capabilities, imaging capabilities, fluid dispensing and retrieval capabilities, and functional (e.g., therapeutic and diagnostic) capabilities. The functionality of the scope 102 is described in detail below with reference to the endoscope 14 of FIGS. 3-5B and is thus shown only schematically in FIGS. 1 and 2.

[0028] The term "tissue separation device" is used throughout the present disclosure, but the tissue separation device 106 can alternatively or additionally include a biological material collection device, a biological material recovery device, a tissue collection device, and a tissue recovery device. The tissue separation device 106 can be configured as any suitable device configured to obtain, recover, 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, etc. Specifically, the tissue separation device 106 can include any device suitable for removing tissue from the patient, such as a blade, a punch, or an auger. The tissue separation device 106 can be configured to physically separate a portion of the patient's tissue from another, larger portion of the patient's tissue. In a further example, the tissue separation device 106 can be configured to simply collect from the patient a biological material that does not require physical separation, such as mucus or fluid that is already or naturally separated or distinct. In the example shown, the tissue separation device 106 can include forceps having separators 138A and 138B configured as sharp or serrated jaws pivotally connected at a hinge 136. However, the tissue separation device 106 can be configured as various devices capable of collecting biological materials, such as a punch, an auger, a blade, a saw, etc., as described. The tissue separation device 106 can be configured to hold a large amount of collected biological material, such as tissue, between the separators 138A and 138B, etc. Thus, the tissue separation device 106 can be configured to be withdrawn from the scope 102 to obtain the biological material collected for diagnostic analysis or disposal, etc.

[0029] FIG. 3 is a schematic diagram of an endoscopy system 10 including an imaging and control system 12 and an endoscope 14. The system of FIG. 3 is an example useful for explaining an endoscopy system suitable for use with systems, devices, and methods described herein, such as a colonoscopy procedure, a weight loss procedure, etc., that can 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 can include the scope 102 of FIGS. 1 and 2 and can be insertable into an anatomical region to enable passage of one or more sampling devices for imaging and / or for biopsy and / or one or more treatment devices for treatment of a medical condition associated with the anatomical region. The endoscope 14 can, in an advantageous aspect, be in communication with and connected to the imaging and control system 12. In the example shown, the endoscope 14 includes an end-viewing colonoscope, although other types of endoscopes can be used with the features and teachings of the present disclosure.

[0030] The imaging and control system 12 can 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.

[0031] The imaging and control system 12 can include various ports for connection to the endoscopy system 10. For example, the control unit 16 can include a data input / output port for receiving data from and transmitting data to the endoscope 14. The light source unit 22 can include an output port for sending light to the endoscope 14 via, for example, an optical fiber link. The fluid source 24 can include a port for sending fluid to the endoscope 14. The fluid source 24 can comprise a pump and a fluid tank, or can be connected to an external tank, container, or storage unit. The suction pump 26 can comprise a port used to create a vacuum in the endoscope 14 to generate a suction force, such as for drawing fluid from the anatomical region into which the endoscope 14 is inserted. The output unit 18 and the input unit 20 can 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 can further be used to generate a signal or other output for treating the anatomical region into which the endoscope 14 is inserted. In some examples, the control unit 16 can generate an electrical output, an acoustic output, a fluid output, etc. for treating the anatomical region, such as by cauterization, cutting, freezing, etc.

[0032] The endoscope 14 can comprise an insertion section 28, a functional section 30, and a handle section 32 that can be connected to a cable section 34 and a connector section 36. The connector section 36 can be connected to the control unit 16 for connecting the endoscope 14 to a plurality of 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.

[0033] Insertion section 28 can extend distally from handle section 32, and cable section 34 can extend proximally from handle section 32. Insertion section 28 can be elongated and can include a flexible section and a distal end to which functional section 30 can be attached. The flexible section can be controllable (e.g., by a tension wire connected to control knob 38 on handle section 32) for manipulation through a serpentine anatomical passage (e.g., stomach, duodenum, kidney, ureter, colon, etc.) to the distal end. Insertion section 28 can also include one or more working channels (e.g., internal lumens), which can be elongated and can assist in the insertion of one or more treatment tools of functional section 30, such as tissue separation device 106 of FIGS. 1 and 2. The working channels can extend between handle section 32 and functional section 30. Additional functionality, such as fluid channels, guide wires, and tension wires, can also be provided by insertion section 28 (e.g., via a suction channel or irrigation channel, etc.).

[0034] Handle section 32 can include not only knob 38 but also port 40A. Knob 38 can be coupled to a tension wire or other actuation mechanism that extends through 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 tubes, etc. to handle section 32 for connection to insertion section 28. For example, tissue separation device 106 can be fed into endoscope 14 via port 40A.

[0035] According to some examples, imaging and control system 12 can be provided on a mobile platform (e.g., cart 41) having a shelf for housing a light source unit 22, a suction pump 26, an image processing unit 42 (FIG. 4), etc. Alternatively, some components of imaging and control system 12 shown in FIGS. 3 and 4 can be provided directly on endoscope 14 to make the endoscope "built-in".

[0036] The functional section 30 can include components for treating and diagnosing a patient's anatomical structure. The functional section 30 can include an imaging device, an illumination device, and an actuator. The functional section 30 can include imaging and illumination components configured for end-viewing, such as further described with reference to the camera module 70 of FIGS. 5A and 5B, configured for a field of view beyond, for example, distally or axially of the functional section 30.

[0037] FIG. 4 is a schematic view of the endoscopy system 10 of FIG. 3, comprising an imaging and control system 12 and an endoscope 14. FIG. 4 schematically shows the components of the imaging and control system 12 connected to the endoscope 14, which, in the example shown, comprises an end-viewing colonoscope. The imaging and control system 12 can include a control unit 16, which can include or be connected to an image processing unit 42, a treatment generator 44, and a drive unit 46, in addition to a light source unit 22, an input unit 20, and an output unit 18. A connector section 36 can be connected to the control unit 16 to connect the endoscope 14 to a plurality of 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 dotter scope or an 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, the port 40B can be used to connect the connector section 36 to various inputs and outputs, such as video, air, light, and electricity.

[0038] The image processing unit 42 and the light source unit 22 can each interact with the endoscope 14 (e.g., in the functional section 30) by means of a wired or wireless electrical connection. Thus, the imaging and control system 12 can illuminate an anatomical region, collect signals representing the anatomical region, process signals representing the anatomical region, and display an image representing 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 using light of a desired spectrum (e.g., broadband white light, narrowband imaging using a preferred electromagnetic wave wavelength, 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 the light source, video signal from the imaging system at the distal end, diagnostic and sensor signals from diagnostic devices, etc.).

[0039] The fluid source 24 (FIG. 1) can communicate with the control unit 16 and can comprise one or more sources of air, saline, or other fluids, as well as associated fluid paths (e.g., air channels, irrigation channels, suction channels) and connectors (bayonet joints, fluid seals, valves, etc.). The imaging and control system 12 can also include a drive unit 46, which can be an optional component. The drive unit 46 can comprise an electric drive for advancing the distal section of the endoscope 14, as described, for example, in Patent Document 1 by Frassica et al. entitled "Rotate-to-Advance Catheterization System", which is hereby incorporated by reference in its entirety for all purposes.

[0040] Figures 5A and 5B show an example of the functional section 30 of the choledochoscope 14 of FIG. 4. FIG. 5A shows an end view of the functional section 30, and FIG. 5B shows a cross-sectional view of the functional section 30 along the cross-section plane 5B-5B of FIG. 5A. FIGS. 5A and 5B each show an “end-viewing endoscope” (e.g., a gastroscope, a colonoscope, a choledochoscope, etc.) camera module 70. In the end-viewing endoscope camera module 70, the illumination system and the imaging system are arranged such 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 coincides with the central longitudinal axis A1 of the endoscope 14.

[0041] In the example of FIGS. 5A and 5B, the end-viewing endoscope camera module 70 can include a housing 72, a treatment unit 74, a fluid outlet 76, an illumination lens 78, and an objective lens 80. The housing 72 includes an end cap for the insertion section 28, thereby providing a seal to the lumen 82.

[0042] As can be seen in FIG. 5B, the insertion section 28 can include a lumen 82 through which various components can extend to connect the functional section 30 to the handle section 32 (FIG. 4). For example, the illumination lens 78 may be connected to a light transmitter 84, which can include an optical fiber cable or cable bundle that extends to the light source unit 22 (FIG. 4). Similarly, the objective lens 80 may be coupled to an imaging unit 87, which may be connected to wiring 88. Also, the fluid outlet 76 may be connected to a fluid line 89, which can include a tube that extends to a fluid source 24 (FIG. 4). In some examples, one of the fluid outlets 76 can include an inlet connected to a fluid line 89 configured for suction, such as being connected to a vacuum for the collection of cleaning and irrigation fluids. Other elongate elements, such as tubes, wires, cables, can extend through the lumen 82 to connect the functional section 30 to components of the endoscopy system 10, such as the suction pump 26 (FIG. 4) and the treatment generator 44 (FIG. 4). For example, the treatment unit 74 can include a large-diameter lumen for receiving other treatment components, such as a cutting device and a treatment device that includes a tissue separation device 106.

[0043] The endoscope camera module 70 can also include a photosensitive element, such as a charge-coupled device (“CCD” sensor) or a complementary metal-oxide semiconductor (“CMOS”) sensor. In any example, the imaging unit 87 can be coupled (e.g., via a wired or wireless connection) to an image processing unit 42 (FIG. 4) to transmit a signal (e.g., a video signal) from the photosensitive element representative of an image to be displayed on a display, such as the output unit 18. In various examples, the imaging and control system 12, as well as the imaging unit 87, can be configured to provide an output at a desired resolution suitable for an endoscopy procedure (e.g., at least 480p, at least 720p, at least 1080p, at least 4k UHD, etc.).

[0044] As described herein, working channel 74 can be used to deliver tissue separation device 106 to the target tissue. Further, suture device 108 can be disposed on the distal end portion of housing 72 to provide suturing functionality distal to illumination lens 78 and objective lens 80. Further, reinsertion sheath 104 can be disposed around the proximal insertion section 28 of housing 72 to enable the endoscope 14 to be inserted into and withdrawn from anatomical structures without or with minimal steering and guidance.

[0045] FIG. 6 is a schematic side view of the reinsertion sheath 104 of the present disclosure showing slit 126 in shaft 122. FIG. 7 is a schematic cross-sectional view of the reinsertion sheath 104 of FIG. 6 showing internal lumen 124 extending within shaft 122. Shaft 122 can include slit 126 that forms flanges 128A and 128B. In some examples, shaft 122 can further include a rotatable door 148. FIGS. 6 and 7 are discussed simultaneously.

[0046] Shaft 122 can extend axially along axis A from a first proximal end 150 to a second distal end 152. In the example shown, flanges 128A and 128B can form end faces that are spaced apart a distance. In other examples, flanges 128A and 128B can contact each other to form a continuous 360-degree perimeter. In some examples, rotatable door 148 can extend from a channel in one of the flanges 128A into a channel in the other of the flanges 128B. Rotatable door 148 can be opened to enable the scope to be disposed inside lumen 124 and then rotated and closed to secure the scope inside.

[0047] The lumen 124 can extend between a proximal end 150 and a distal end 152. The lumen 124 can extend in a radial direction R from an 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 anatomical structure. 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 thus may be longer in the direction L than shown.

[0048] The shaft 122 can be fabricated from any suitable biocompatible material. In some examples, the shaft 122 can be made of a polymeric material. The material of the shaft 122 can allow the reinsertion sheath 104 to be deformed via an operation by an operator such as a surgeon. For example, the operator of the reinsertion sheath 104 can pull apart the flanges 128A and 128B to allow the scope 102 (FIG. 1) to be disposed inside the lumen 124. However, the reinsertion sheath 104 can be configured to maintain rigidity for moving the anatomical structure and guiding the instrument through the lumen 124 when disposed within the anatomical structure. The thickness T can be selected such that the reinsertion sheath 104 can be contracted or wrinkled as shown in FIG. 8A but extended to provide a desired passage through the anatomical structure. Thus, the thickness T can be selected such that the operator can manually shrink or extend the length L, but once extended, the shaft 122 can be configured to maintain its shape.

[0049] FIG. 6 is intended to show the fully extended length of the shaft 122 in a quiescent state where the outer surface 154 is approximately linear and not subjected to any compressive or tensile loads. However, the shaft 122 can be subjected to a compressive force to reduce the length L, as shown in FIG. 8A.

[0050] Figure 8A is a schematic side view of the reinsertion sheath 104 of FIGS. 6 and 7 in a compressed state. The reinsertion sheath 104 can be compressed along axis A1 into the wavy state of FIG. 8A. The outer surface 154 of the reinsertion sheath 104 can be compressed to form undulations 156 as wrinkles are gathered in the material of the shaft 122.

[0051] Figure 8B is a schematic side view of the reinsertion sheath 104 of FIG. 8A in an extended state along axis A1. Thus, the undulations 156 can be weakened as wrinkles are gathered in the shaft 122. In some examples, the reinsertion sheath 104 can be made of a rigid corrugated plastic having radially extending rigid body portions connected by living hinges so that the reinsertion sheath can be selectively extended and bent into a desired orientation.

[0052] In some examples, the material of the shaft 122 can be flexible to allow the sheath 104 to expand and contract radially along axis A1. The material of the shaft 122 can include a flexible polymer sheet reinforced with webbing, such as a ripstop material. To provide radial rigidity to the sheath 104, the shaft 122 can include various means for supplementary stiffening to maintain a desired outer diameter of the sheath 104, as discussed with reference to FIGS. 9A-10B.

[0053] Figure 9A is a schematic side view of a reinsertion sheath 160 having an expandable support 162 in a contracted state. Figure 9B is a schematic side view of the reinsertion sheath 160 of FIG. 9A in an extended state. FIGS. 9A and 9B are discussed simultaneously.

[0054] The reinsertion sheath 160 can be configured similarly to the reinsertion sheath 104 of FIGS. 6 - 8B, with the addition of cross - supports or struts 164A and 164B. The reinsertion sheath 160 can include an expandable support 162 attached to a body 166 that can extend from a first end 167 to a second end 168. The expandable support 162 can include struts 164A and 164B that can be connected at a hinge 165. A slit 169 can extend across the body 166. The slit 169 is schematically shown as extending along the body 166. The slit 169 can be disposed on the body 166 on the opposite side of the expandable support 162. Thus, when viewed from the end of the reinsertion sheath 160 as in the view of FIG. 7, the struts 164A and 164B can have a C - shape with the slit 169 forming the ends of the C.

[0055] The struts 164A and 164B can include wires or bars embedded in or attached to the material of the body 166 either inside or outside the lumen 124. The struts 164A and 164B can include rigid or stiff members for supporting the material of the body 166 in the radial and circumferential directions with respect to the axis A1. The hinge 165 can include a pivot point to allow the struts 164A and 164B to rotate relative to each other while maintaining contact to provide radial and circumferential support to the body 166. The struts 164A and 164B can be configured to minimally affect the axial rigidity of the reinsertion sheath 160.

[0056] The body 166 can have a skin provided over the expandable support 162 to provide a shaft structure. The skin can include a flexible polymer sheet reinforced with a webbing such as a rip - stop material. The body 166 can be configured to provide a desired axial rigidity to the reinsertion sheath 160.

[0057] FIG. 9A shows struts 164A and 164B in a folded state where the ends of struts 164A and 164B are close to each other. However, as can be seen in FIG. 9B, struts 164A and 164B can be opened by rotating at hinge 165 as the reinsertion sheath 160 expands such that ends 167 and 168 are further apart compared to FIG. 9A.

[0058] Accordingly, the body 166 of the reinsertion sheath 160 can be compressed by the struts 164A and 164B being rotated at the hinge 165 to the state of FIG. 9A to facilitate assembly with the scope. If it is desirable to deploy the reinsertion sheath 160, the operator can circumferentially pull apart the body 166 at the slit 169 to enable the sheath 160 to be placed on the shaft 110 of the scope 102. Specifically, the folded reinsertion sheath 160 can be placed on the proximal end of the shaft 110 while the distal end of the shaft 110 is disposed within the patient's anatomical structure. Once placed on the shaft 110, the operator can push the distal end of the reinsertion sheath 160 along the shaft 110 into the patient's anatomical structure. As described, the rigidity of the body 166 can be such that the operator can unfurrow the body 166 from the folded configuration, but since the size of the body 166 additionally increases, the body 166 can maintain its unique shape under pressure from the anatomical structure. The struts 164A and 164B can provide radial stiffening to the reinsertion sheath 160 to enable the body 166 to resist the anatomical structure and to enable other devices and instruments, such as the scope 102 (FIGS. 1 and 2), to be inserted therein. Accordingly, the length L (FIG. 6) of the reinsertion sheath 160 can be sufficient to reach or approach the distal end of the scope 102. When the reinsertion sheath 160 is deployed within the anatomical structure and is fully extended or extended sufficiently to reach the end portion of the scope 102, the scope 102 can be withdrawn and the reinsertion sheath 160 can remain. Accordingly, the inner diameter D2 (FIG. 7) can provide a body that forms a tunnel to the desired anatomical structure. Thus, the scope 102 need not be independently guided back to the original anatomical structure and can be easily inserted into the reinsertion sheath 160 to reach the desired anatomical structure.Accordingly, 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 FIGS. 14-23, and then reinserted with the suturing device to reach the same anatomical structure.

[0059] FIG. 10A is a schematic side view of a reinsertion sheath 170 having a helical support member 172 in a contracted state. FIG. 10B is a schematic side view of the reinsertion sheath 170 of FIG. 10A in an extended state. FIGS. 10A and 10B are discussed simultaneously.

[0060] The reinsertion sheath 170 can include a body 176 extending between ends 177 and 178. A slit 179 can extend along the body 176. The reinsertion sheath 170 can be configured similarly to the reinsertion sheath 160 of FIGS. 9A and 9B with the expandable support 162 replaced by the helical support member 172. The helical support member 172 can include a rigid or stiff member that spirals along the reinsertion sheath 170 between ends 177 and 178.

[0061] The slit 179 can extend across the body 176. The slit 179 is schematically shown as extending along the body 176. The slit 179 can be disposed on the body 176 on the opposite side of the helical support member 172. Accordingly, when viewed from the end of the reinsertion sheath 170 as in the view of FIG. 7, the helical support member 172 can have a C-shape with the slit 169 forming the end of C. Accordingly, the helical support member 172 may not form a continuous spiral shape between ends 177 and 178, but can be formed of a plurality of helical segments.

[0062] Similar to the expandable support member 162 of FIGS. 9A and 9B, the helical support member 172 can provide radial and circumferential stiffening to the body 176 to enable support against the pressure of the anatomical structure and to form a body that defines a tunnel for the insertion of the instrument. However, the helical support member 172 can allow axial expansion and contraction of the body 176 so that the natural rigidity of the body 176 can be utilized to enable axial contraction and expansion of the reinsertion sheath 170 and thus deployment, as described with reference to FIGS. 9A and 9B.

[0063] 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 mating teeth 186A and 186B on opposite sides 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 combination with any of the reinsertion sheaths described herein, such as the 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.

[0064] The teeth 186A can be disposed along one side of the slit 185. The teeth 186B can be disposed along a second side of the slit 185. The teeth 186A and 186B can be staggered such that the teeth 186A can fit between the teeth 186B and vice versa. The shuttle 188 can be used to couple and separate the teeth 186A and 186B. Thus, the zipper closure mechanism 182 can function as a zipper in a conventional manner.

[0065] The zipper closure mechanism 182 can be released to allow the teeth 186A and 186B to separate. Accordingly, the reinsertion sheath 180 can be disposed around the shaft of the scope. The reinsertion sheath 180 can be inserted into the anatomical structure with the first end 187A disposed distally such that it enters the anatomical structure first. As the shaft 184 is pushed or fed distally into the anatomical structure, the shuttle 188 can be pulled proximally to engage the teeth 186A and 186B. Accordingly, as the shaft 184 is expanded and further fed into the anatomical structure, the shuttle 188 can be advanced to close the shaft 184.

[0066] 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 comprise 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 comprise 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.

[0067] The first rail 195A and the second rail 195B can be disposed at the ends of the shaft 192 that form the slit 193 in an overlapping manner, as described with reference to FIG. 13.

[0068] Figure 12B is a cross-sectional view of the re-insertion sheath closure mechanism 191 of Figure 12A. The engagement 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 the spherical heads. In one example, the engagement rail closure mechanism 191 can be configured according to Patent Document 2 of Pawloski et al., which is hereby incorporated by reference in its entirety.

[0069] As shown in Figure 12B, the end of the slit 193 can be pulled so that the portions of the shaft 192 overlap to allow the slots 197A and 197B and the protrusions 196A and 196B to interact with each other, respectively. The protrusion 196A and the slot 197A are arranged in an overlapping configuration and can be pressed against each other by an operator to lock. Similarly, the protrusion 196B and the slot 197B are arranged in an overlapping configuration and can be pressed against each other by an operator to lock. In one example, a shuttle can be provided on the engagement rail closure mechanism 191 to facilitate pressing the protrusions 196A and 196B against the slots 197A and 197B and separating the aforementioned components. Either of the ends 194A and 194B can first be fed into the anatomical structure.

[0070] FIG. 13 is a schematic view of a reinsertion sheath 104 comprising a long shaft 176 having a lumen 124 and a gap 126. The gap 126 can include a plurality of magnetic members 198, and a metal strip 199. The magnetic member 198 can be attracted to the metal strip 199 via magnetic force. Thus, in a stationary state, the magnetic member 198 can pull the end of the long shaft 176 along the closed gap 126. However, the magnetic member 198 can be pushed away from the metal strip 199 to allow a device or object to enter the lumen 124 in the radial direction. After the device or object enters the lumen 124, the magnetic member 198 can be pulled back to engage with the metal strip 199 via magnetic attraction. Thus, the sheath 104 can be easily slid over the long body 110 of the scope 102 while the scope 102 is inserted into the anatomical structure.

[0071] Figures 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, and this tunnel 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 been pre-directed (e.g., steered, rotated, controlled, and manipulated to push through desired anatomical features and conduits) to a target tissue site within the anatomical structure. Thus, the pre-inserted instrument can function as a type of guide 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 enable placement of the reinsertion sheath onto the instrument in a radial direction relative to the axis of the instrument. Thus, the reinsertion sheath can be placed on the proximal end of the instrument while the distal end of the reinsertion sheath is disposed within the anatomical structure. The material of the reinsertion sheath can form a skin radially reinforced by wires or bars, and this skin is axially compressible, e.g., capable of being axially shrunk or folded, so as to fit only over a portion of the length of the instrument, e.g., the portion of the instrument that is not inserted into the anatomical structure. Thus, the reinsertion sheath can be more easily manipulated. When placed on the proximal portion of the inserted instrument, the reinsertion sheath can be expanded or spread to push the distal portion of the reinsertion sheath into the patient's anatomical structure around the instrument. Axially foldable support features can be used to provide the reinsertion sheath with radial rigidity to push the anatomical structure 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 straight route to the target tissue site.

[0072] FIG. 14 is a schematic perspective view of a suture device 200 attached to an endoscope 202. The endoscope 202 can be configured according to any of the scopes described herein and can include a shaft 204, an end face 206, a working channel 208, an imaging component 210, an illumination component 212, and an irrigation channel 214. The suture device 200 can include a coupler 216, a suture body 218, a housing 220, a control element 222, and a hinge 225. As discussed herein, the suture body 218 can include a device for moving suture elements such as needles, staples, shuttles, etc. to draw and / or push suture material through tissue. In some examples, an electromagnetic drive device can be used to move an arcuate suture needle via direct or indirect electromagnetic forces. The suture device 200 is described as a device that can be detachably attached to the scope 202, but in further examples, the suture device 200 or its components (e.g., suture body 218, housing 220, control element 222, and hinge 225) can be directly incorporated into the scope 202.

[0073] The connector 216 can comprise a rigid or flexible body that facilitates connection with the shaft 204. The connector 216 can comprise an annular body having a channel 224 that passes from one end to the other along axis A2. The shaft 204 can extend along axis A1 of the foregoing figures. The shaft 204 of the endoscope 202 can be sized to fit concentrically within the channel 224 to hold the suturing device 200 attached to the endoscope 202. In some examples, an interference fit can be formed between the channel 224 and the shaft 204. The channel 224 can extend straight to the distal end of the connector 216 or can include a flange to prevent the connector 216 from being pushed proximally along the shaft 204. Such a flange can ensure proper placement of the suture body 218 relative to the end face 206 to ensure that the suture body 218 is within the field of view of the imaging component 210 and the illumination component 212. However, the channel 224 can allow sufficient end face 206 to be exposed without interfering with the working channel 208, the imaging component 210, the illumination component 212, and the irrigation channel 214. Thus, the connector 216 can form a cap that is removably attached to the shaft 204. The channel 224 and the shaft 204 can further include features (not seen in FIG. 14) to facilitate rotational alignment between the suturing device 200 and the scope 202, such as providing proper orientation between the working channel 208, the imaging component 210, the illumination component 212, and the irrigation channel 214 of the scope 202 and the socket 230 of the suturing device 200. In some examples, the rotational alignment feature can comprise an axially extending channel that extends into the end face 206 at a particular circumferential position that is capable of receiving a corresponding axially extending flange on the channel 224, or the reverse configuration.

[0074] The suturing body 218 can extend distally of the connector 216 so as to be disposed distally of and within the field of view of the imaging component 210 and the illumination component 212. The suturing body 218 can be connected to the connector 216 via a hinge 225. The suturing body 218 can include opposing arms 226A and 226B each including suturing tracks 228A and 228B. The opposing arms 226A and 226B can be disposed around a socket 230, which can form a space for receiving tissue for suturing. The suturing tracks 228A and 228B can each extend in an arcuate manner into end faces 229A and 229B, and can have a radius of curvature centered about axis A3. The control element 222 can extend from the suturing body 218 and can include a cable or wire configured to provide power and control signals to components within the suturing body 218 such as electromagnetic coils discussed herein. The control element 222 can be configured to extend along the exterior of the shaft 204 for connection to the control device 112 when the suturing device 200 is assembled with the scope 102. Thus, the reinsertion sheath 204 can be configured to fit around the control element 222 as shown in FIG. 2. However, the control element 222 can extend further through a lumen within the shaft 204.

[0075] As discussed herein, the suturing body 218 can include electromechanical components capable of generating an electromagnetic field within the arms 226A and 226B and between the arms 226A and 226B to push and / or pull a magnetic suturing element, such as a needle, between the suturing tracks 228A and 228B.

[0076] FIG. 15A is a side schematic view of the suturing device 200 of FIG. 14 showing the suturing body 218 rotated into the same plane as the connector 216 via the hinge 225. FIG. 15B is a side schematic view of the suturing device 200 of FIG. 14 showing the suturing body 218 rotated away from the connector 216 via the hinge 225. FIGS. 15A and 15B are discussed simultaneously.

[0077] The housing 220 can be disposed under the proximal coupler 216 of the suturing body 218. The housing 220 can include control elements such as an electronic device, a motor, a power source, etc. for the elements of the suturing body 218. The control element 222 (FIG. 14) can extend proximally from the housing 220 to connect the suturing body 218 to the control device. The housing 220 can further include a large amount of suturing material and components for tying or mooring the suturing material. The suturing body 218 can be rotatably connected to the coupler 216 via a hinge 225. The shaft 204 of the endoscope 202 (FIG. 14) can extend into the channel 224 of the coupler 216. The distal face 206 of the shaft 204 can be distally exposed to the outside of the coupler 216 so that the space 230 can be seen.

[0078] Referring to FIG. 15A, the scope 202 can be more easily guided through the anatomical structure with the suturing body 218 rotated to engage the face 206 of the shaft 204. Thus, the arms 226A and 226B do not protrude distally of the face 206 and are unlikely to interfere with the operation of the imaging components 210 and the lighting components 212 for guiding purposes. However, the space 230 between the arms 226A and 226B can be disposed adjacent to the face 206 to enable the imaging components 210 and the lighting components 212 to have visibility on the opposite side of the suturing body 218.

[0079] Referring to FIG. 15B, when the suture body 218 is guided to the desired position of the target tissue within the anatomical structure, it can be rotated at the hinge 225 to extend the arms 226A and 226 outwardly in front of the surface 206. Thus, the imaging component 210 and the illumination component 212 can interact with the target tissue between the arms 226A and 226B without the need to guide the shaft 204. The suture device 200 can include a motor to provide a rotational input to the suture body 218 at the hinge 225. The motor can be connected to the control element 222 such that the operator of the scope 204 can selectively operate the motor to raise and lower the suture body 218.

[0080] FIG. 16 is a schematic cross-sectional view of the electromagnetic suturing mechanism 240 of the suture device 200 of the present disclosure, comprising an arcuate suture element 242 disposed between arcuate tracks 228A and 228B and a coil 244. The coil 244 can include lead wires 246A and 246B. The suture element 242 can include a body 248, tips 250A and 250B, and a small hole 252. The suture element 242 can be connected to a suture material 254. A winding 256 of the suture material 254 can be stored on a spool 258. A closure device 259 can be disposed on the suture device 200 to receive the suture material 254 from the spool 258. The closure device 259 can be configured to attach components (e.g., anchors) to the suture material 254 or impart features (e.g., knots) to the suture material 254 to enable the suture material to be tightened onto the tissue.

[0081] As discussed with reference to FIGS. 17A - 17D, the suture element 242 can be moved between tracks 228A and 228B to pull the suture element 242 through tissue. As discussed with reference to FIGS. 18 - 20, the suture element 242 can be moved between tracks 228A and 228B via various electromagnetic and mechanical actions to reciprocate or circulate the suture element 242 between tracks 228A and 228B. The suture tracks 228A and 228B, and the arms 226A and 226B can comprise arcuate segments such that the suture body 218 has a "C" shape. In some examples, the tracks 228A and 228B, and the arms 226A and 226B can be arc segments centered about axis A3. Axis A3 may be perpendicular to axis A2 of the coupler 216, and axis A2 may be coaxial with axis A1 of the shaft 204 of the scope 202 (FIG. 14).

[0082] In the example of FIG. 16, power can be provided from the control element 222 through leads 246A and 246B to the coil 244. The coil 244 can comprise a copper winding on which the material of the arm 226A is formed. The control element 222 can be connected to a power source at the hinge 225 or proximally to the control unit 16. Power can pass through the coil 244 to generate an electromagnetic field. The electromagnetic field can be configured to advance the suture element 242 from track 228A toward track 228B. Thus, the tip 250B can penetrate tissue and pull the suture material 254 through the tissue. The suture material 254 can be attached to the suture element 242 at the small hole 252, which can comprise a bore or another feature to which the suture material 254 can be attached. As the suture element 242 is moved, the suture material 254 can be drawn from the spool 258. The spool 258 can be rotatably mounted within the hinge 225, the suture body 218, or the housing 220. The suture element 242 can be fully pushed into the track 228B. As discussed herein, the suture element 242 can be returned to the track 228A via various electromagnetic or mechanical actions, such as direct electromagnetic propulsion from a coil within the arm 226B, reverse electromagnetic propulsion from the coil 244, mechanical force from the arm 226A, or mechanical force from the arm 226B. The tip 250A can enable the suture element 242 to penetrate tissue as soon as it returns to the track 228A.

[0083] The closure device 259 can be configured to attach an anchor element to the suture material 254. In some examples, the closure device 259 can attach an anchor 266 (FIG. 17B), which can comprise a sphere of polymeric material secured onto the suture material 254. In further examples, the closure device 259 can include a staple that presses the suture material 254 against the tissue, or a tack that is fastened to the suture material 254.

[0084] The suture element 242 can comprise a body 248 having an arcuate shape. The curvature of the body 248 can match the curvature of the tracks 228A and 228B. However, in other examples, the suture element 242 can be straight and of a length short enough to fit within the curvature of the tracks 228A and 228B. The aperture 252 is shown disposed at the center of the body 248. However, the aperture 252 can be disposed at other locations, such as proximal to one of the tips 250A or 250B. The body 248 can be made of a ferromagnetic material to interact with the electromagnetic field of the coil 244. The body 248 can be a magnet or can be magnetized. The body 248 can further be made of a biocompatible material and / or a bioabsorbable material.

[0085] Figures 17A - 17D are schematic views of the electromagnetic suture device 240 of FIG. 16, passing the suture element 242 through the tissue 260 to draw the suture material 254 into the tissue 260 to close the incision 262. The incision 262 can be formed between tissue portions 264A and 264B of the tissue 260. The tissue 260 can be the wall of an anatomical passage. The incision 262 can be an unwanted perforation through the wall that can be closed to prevent bleeding. In another example, the tissue portions 264A and 264B can include portions of the stomach wall that are sutured to each other to reduce the size of the stomach in a weight loss procedure. For the sake of brevity, not all elements of the electromagnetic suture device 240 and the suture device 200 are shown in each of FIGS. 17A - 17D.

[0086] In FIG. 17A, the tissue 260 is disposed within the space 230 between the arms 226A and 226B. The end faces 229A and 229B can abut the tissue 260 to dispose the tracks 228A and 228B (FIG. 16) adjacent to the target tissue. The suture element 242 can be disposed within the track 228A (FIG. 16) in the arm 226A. The suture material 254 can extend from the spool 258 to the suture element 242 via any suitable passageway. In some examples, the spool 258 can be installed within the hinge 225. The coil 244 can be excited to generate an electromagnetic field to push the suture element 242 from the arm 226A toward the arm 226B.

[0087] In FIG. 17B, the suture element 242 can be disposed within the tissue 260. The suture material 254 can include an anchor 266. The anchor 266 can be dispensed by the closure device 259 (FIG. 16) when the suture material 254 is drawn from the spool 258 (FIG. 17A). The closure device 259 can simultaneously cut the suture material 254 from the other suture material windings 256 on the spool 258. Thus, one suture material 254 can be provided to close the incision 262. The suture material 254 can be attached to the suture element 242 via a small hole 252 and a knot or another suitable attachment feature.

[0088] In FIG. 17C, the suture element 242 can be pushed through the tissue 260 and into the arm 266B (FIG. 17) via, for example, the continued operation of the coil 244 to generate an electromagnetic field. The suture material 254 can follow the suture element 242 such that the suture material 254 completes passage through the first tissue 260. As described herein, the suture element 242 can be further drawn into the tissue 260 via electromagnetic means and / or mechanical means.

[0089] In FIG. 17D, the suturing device 200 can be operated to push the suture element 242 back into and through the tissue 260. The suturing device 200 can be moved axially along the incision 262, away from the position where the suture element 242 was first passed through the tissue 260, such as closer to the tip of the tissue 260. Next, the suturing device 200 can be actuated to move the suture element 242. As discussed with reference to FIGS. 18-20, the suturing device 200 can be configured to return the suture element 242 to the arm 226A via pushing or pulling by electromagnetic force or via pushing or pulling by mechanical force. The suturing device 200 can be operated to push the suture element 242 through the tissue 260 and back into the arm 226A. The suture material 254 can be pulled to engage the anchor 266 with the tissue 260.

[0090] In FIG. 17E, the suturing device 200 can be operated to tension the suture material 254. An electromagnetic or mechanical force can be generated to push and pull the suture material 254 to remove the slack in the suture material 254 shown in FIG. 17B between the tissue 260 and the anchor 266. The suture element 242 can be advanced until the anchor 266 engages the tissue 260. Accordingly, the incision 262 between the tissue portions 264A and 264B of the incision 262 can be pulled to engage. At such a point, the suture material 254 can be released from the suture element 242. In some examples, one or both of the arms 226A and 226B (FIG. 17A) can include a blade or another device for separating the suture material 254 from the suture element 242. As shown in FIG. 18, another closure device 278 (FIG. 18) can be provided between the arms 226A and 226B to act on the suture material 254 to prevent the suture material 254 from exiting the tissue 260 rearwardly. For example, another anchor 266 can be applied to the end of the suture material 254. In a further example, the suture element 242 can be left in the tissue 260 and can dissolve or be resorbed into the anatomical structure.

[0091] FIG. 18 is a schematic cross-sectional view of an electromagnetic stitching mechanism 270 of the present disclosure that includes a stitching element 272 that is magnetically driven and spring-retracted. The stitching mechanism 270 and the stitching element 272 of FIG. 18 can be configured similarly to the stitching mechanism 240 and the stitching element 242 of FIG. 16, with the following variations. The stitching mechanism 270 can include a spring 274 for applying a mechanical restoring force to the stitching element 272. Accordingly, the stitching element 272 can include a tip 250B at its leading edge, and the spring 274 can be attached to the trailing edge of the stitching element body 248. Thus, the coil 244 can be actuated to provide motive power for the stitching element 272 from the arm 226A towards the arm 226B. The spring 274, or another mechanical biasing element, can provide motive power to pull the stitching element 272 back towards the arm 226A. Accordingly, the stitching element 272 can be reciprocated back and forth using electromagnetic and mechanical motive forces.

[0092] The stitching mechanism 270 can also include a closure device 278. The closure device 278 can be disposed within the path of the stitching element 272. In the example shown, the closure device 278 can be disposed on the arm 226B such that the stitching element 272 passes through the closure device 278 after passing through the tissue. The closure device 278 can comprise a device for facilitating attachment of the suture material 254 to the tissue 260. In one example, the closure device 278 can apply heat to the suture material to cause melting of the material and join the suture material 254 to the twist of another suture material. In one example, the closure device 278 can apply an anchor, such as an anchor 266 or another element, to the suture material 254. In a further example, the closure device 278 can attach the twist of another suture material to the suture material 254 in a manner similar to a sewing machine. The closure device 278 can be used with any of the stitching mechanisms of FIGS. 16, 19, and 20. Thus, in some examples, after the coil 244 has pushed the stitching element 272 into the tissue, the closure device 278 can apply an anchor to the suture material 254 during the return stroke of the stitching element 272 to prevent the suture material 254 from being pulled back from the tissue. Thus, the suture material 254 can be attached to the stitching element 272 near the tip 250B, and the stitching element 272 need not pass completely through the tissue, such as at the location where the spring 274 is attached to the stitching element 272.

[0093] FIG. 19 is a schematic cross-sectional view of an electromagnetic stitching mechanism 280 of the present disclosure, comprising a magnetically circulated stitching element 282. The stitching mechanism 280 and the stitching element 282 of FIG. 19 can be configured similarly to the stitching mechanism 240 and the stitching element 242 of FIG. 16, with the following variations. The stitching mechanism 280 can include a first coil 244A, a second coil 244B, and a third coil 244C for providing an electromagnetic circulating driving force to the stitching element 282 within a circular track 284, and the stitching element 282 can comprise magnetic elements 286A-286C, and barbs 288A-288C. The circular track 284 can replace the tracks 228A and 228B.

[0094] In some examples, one, two, or three of the coils 244A - 244C can be actuated to operate the stitching element 282. As discussed below, the coils 244A - 244C can be operated to provide various combinations of pushing and pulling of the stitching element 282. The control unit 16 (FIG. 14) is connected to the coils 244A - 244C to operate the coils 244A - 244C in various modes to control the timing of actuation of the coils 244A - 244C and the north (N)-south (S) direction of the magnetic poles of the magnetic fields thereby generated to move the stitching element 282. Thus, the control unit 16 is programmable with instructions for operating the coils 244A - 244C in multiple operating modes, and an operator of the stitching mechanism 280 can select one or more modes to operate the stitching element 282, including selecting whether to move the stitching element in a forward or reverse direction in the control device 112.

[0095] In some examples, coils 244A and 244B can be actuated to create a magnetic pushing force on the stitching element 282. Thus, coil 244A can be actuated to push the stitching element 282 towards arm 226B, and coil 244B can be actuated to generate another magnetic force to further continue to push the stitching element 282 into track 284 towards arm 226A subsequently or simultaneously. Thus, the stitching element 282 can be continuously pushed by the magnetic fields generated by coils 244A and 244B. Thus, the coils can be arranged to produce a magnetic field having N and S poles oriented in the same direction, as shown in FIG. 19. Coil 244C can similarly be actuated to push the stitching element 282 in a clockwise direction.

[0096] In some examples, coils 244A and 244B can be actuated to create magnetic pushing and pulling forces on the suture element 282. Thus, coil 244A can similarly be actuated to push the suture element 282 towards arm 226B (a clockwise force), and coil 244B can be simultaneously actuated to generate a separate magnetic force (a clockwise force) to draw the suture element 282 into arm 226B. When the suture element 282 enters arm 226B and is properly positioned relative to coil 244B (e.g., passing through coil 244B), coil 244B can be switched to produce a magnetic pushing force (a clockwise force), and coil 244A can be switched to produce a magnetic pulling force (clockwise). The actuation of coils 244A and 244B can be programmed and adjusted to maximize the motive force applied to the suture element 282. In one example, 1) coil 244A can be actuated to produce a pushing force, coil 244B can be actuated to produce a pulling force, 2) coil 244B can be actuated to produce a pushing force, 3) coil 244A can be actuated to produce a pulling force, and 4) steps 1)-3) are repeated. Coil 244C can similarly be actuated to switch between pulling and pushing the suture element 282 as the suture element approaches and departs from coil 244C.

[0097] The body 248 can include magnetic elements 286A-286C, and the magnetic elements 286A-286C can comprise a magnetic material capable of interacting with the magnetic fields generated by the coils 244A and 244B. The magnetic elements 286A-286C can be configured to have a magnetic field opposite to the magnetic fields generated by the coils 244A and 244B. Thus, when the coils 244A and 244B are actuated, the suturing element 282 can be further propelled by the interaction between the magnetic elements 286A-286C and the magnetic fields of the coils 244A and 244B. In some examples, the coil 244A can be configured to produce a magnetic field having an N pole N1 at the top and an S pole S1 at the bottom with respect to the orientation of FIG. 19, the coil 244B can be configured to produce a magnetic field having an N pole N2 at the bottom and an S pole S1 at the top with respect to the orientation of FIG. 19, and the magnetic elements 286A-286C can be configured to produce a magnetic field having an N pole N3 at the bottom and an S pole S at the top with respect to the orientation of FIG. 19. In some examples, the magnetic elements 286A-286C can be made of a diamagnetic material that is repelled by a magnetic field.

[0098] The body 248 can further include barbs 288A-288C to prevent the suturing element 282 from retrograding within tissue. The barbs 288A-288C can include microhooks, barbs, or fish scales that can easily pass through tissue in the clockwise direction but not in the counterclockwise direction. The barbs 288A-288C can extend radially outward of the body 248 and can flare outward from the body 248.

[0099] In some examples, the circular track 284 can be configured in the shape of an infinity symbol. Thus, the circular track 284 can be rotated along axis A2 such that track 226A further enters the plane of FIG. 19 and track 226B further exits the plane of FIG. 19. A second presence of the track 284 can be superimposed there such that it intersects the track 284 along axis A2 proximal to the spool 258, but can be rotated such that the track corresponding to track 226A further exits the plane of FIG. 19 and the track corresponding to track 226B further enters the plane of FIG. 19. Thus, the stitching element 282 can be configured to move out of the plane of FIG. 19 to provide three-dimensional stitching to the tissue.

[0100] FIG. 20 is a schematic cross-sectional view of an electromagnetic stitching mechanism 290 of the present disclosure, comprising a magnetically reciprocating stitching element 292. The stitching mechanism 290 and the stitching element 292 of FIG. 20 can be configured similarly to the stitching mechanism 240 and the stitching element 242 of FIG. 16, with the following variations. The stitching mechanism 290 can include coils 244A and 244B, and the stitching element 292 can comprise a magnetic element 296.

[0101] Coils 244A and 244B can be configured to reciprocate the stitching element 292. In some examples, coils 244A and 244B can be actuated to create magnetic pushing and pulling forces on the stitching element 282. Thus, coil 244A can be actuated to push the stitching element 282 towards arm 226B (clockwise force), and coil 244B can be simultaneously actuated to generate another magnetic force (clockwise force) to draw the stitching element 282 into arm 226B. When the stitching element 282 enters arm 226B, coil 244B can be switched to produce a magnetic pushing force (counterclockwise force), and coil 244A can be switched to produce a magnetic pulling force (counterclockwise force). The operation of coils 244A and 244B can be programmed and adjusted to maximize the motive force applied to the stitching element 282. In one example, 1) coil 244A can be actuated to produce a pushing force, coil 244B can be actuated to produce a pulling force, 2) coil 244B can be actuated to produce a pushing force, 3) coil 244A can be actuated to produce a pulling force, and 4) steps 1) - 3) are repeated.

[0102] Magnetic element 296 can comprise a magnetic material capable of interacting with the magnetic fields generated by coils 244A and 244B, similar to that described with reference to FIG. 19. Thus, magnetic element 296 can be propelled by the electromagnetic fields generated by coils 244A and 244B. In some examples, magnetic element 296 can be made of a diamagnetic material that is repelled by a magnetic field.

[0103] Figures 21-23 illustrate further examples of an electro-surgical device. The devices of Figures 21-23 may be particularly suitable for use in laparoscopic procedures, but may also be used in other procedures such as endoscopic examination procedures. For example, a laparoscopic procedure may involve using an incision in an anatomical structure to insert a scope. Such an incision can allow for larger instruments compared to, for example, a scope inserted orally. Exemplary laparoscopic procedures include removal of the gallbladder (cholecystectomy), appendectomy, hernia repair, removal of a portion of the colon (colectomy) or a portion of the small intestine, surgery for acid reflux disease (cardiomyotomy), removal of the adrenal gland, and removal of the spleen. Some of these procedures may involve creating internal incisions or cuts that can be closed by suturing. Optionally, it may be advantageous to push and engage two tissues together to suture them. Thus, a laparoscope may be more robust and may involve the use of a pivotable jaw for grasping tissue for suturing, as discussed below.

[0104] Figure 21 is a schematic cross-sectional view of an electromagnetic suturing mechanism 300 of the present disclosure, comprising a magnetically driven hammer 302. The suturing mechanism 300 can comprise a suturing body 304 having an arm 306, a hammer chamber 308, a suture element chamber 310, and a coil 312. The hammer 302 can comprise a drive mass 314 and a driver 316. A suture element 318 can be connected to a suture material 320.

[0105] The suture body 304 can comprise a portion of the suture body 218 (FIG. 14). The suture body 304 can define a hammer chamber 308 and a suture element chamber 310. The hammer chamber 308 can be configured to slidably receive a drive mass 314. The drive mass 314 can comprise a mass of material having a large mass compared to the mass of the suture element 318 to facilitate the transfer of kinetic energy from the hammer 302 to the suture element 318. A driver 316 can extend from the drive mass 314 into the suture element chamber 310. The suture element chamber 310 can be configured to slidably receive the driver 316. The suture element chamber 310 and the driver 316 can be radially smaller than the drive mass 314 and the hammer chamber 308 to form a shoulder 322. Thus, an end face 324 of the drive mass 314 can abut the shoulder 322 to prevent the hammer 302 from being moved out of the hammer chamber 308. However, the driver 316 can be configured to enter the suture element chamber 310 to contact the suture element 318.

[0106] The coil 312 can be actuated by electrical energy to generate an electromagnetic field to push the hammer 302 to the right in FIG. 21. The driver 316 can be configured to strike the suture element 318 to push the suture element 318 to the right. The face 324 of the drive mass 314 can abut the shoulder 322, but the suture element 318 can still be moved to the right. Thus, the suture element 318 can be passed through tissue by a propulsive force. In other examples, the driver 316 can be longer such that it is configured to directly pass the suture element 318 through tissue. The hammer 302 can be returned to the left position via a mechanical element such as a spring or via electromagnetic actuation from the coil 312 in the opposite direction. The suture element 318 can be returned to the left position via any suitable method including those described herein. In some examples, a spring connected to the right side of the suture element 318 can push the suture element to the left. In some examples, another coil within the suture body 304 can electromagnetically push the suture element 318 to the left.

[0107] In some examples, the drive body 316 can comprise a rigid and solid body that can be coaxially aligned with the suture element 318 and the suture element chamber 310. In further examples, the drive body 316 can be curved or arcuate so as to function with a correspondingly curved suture element chamber 310 and suture element 318. In some examples, the drive body 316 can be flexible to operate with an example of a suture element chamber 310 that is inclined with respect to the central axis of the hammer 302. In some examples, the drive block 314 can be made of a metal such as steel, and the drive body 316 can be made from plastics such as PVC, polyethylene, PPEK, and polypropylene. Thus, the metal components may be made of a higher density material to provide driving force, and the plastic components may be made to bend as necessary to guide the suture element.

[0108] FIG. 22 is a schematic cross-sectional view of electromagnetic stapling mechanisms 300A and 300B and magnetically driven hammers 302A and 302B used with a stapling device 330 having arms 332A and 332B. Arm 332A can include aligned channels 334A and angled channels 336A. Arm 332B can include aligned channels 334B and angled channels 336B. Although not shown in FIG. 22, arms 332A and 332B can be connected at opposite ends of angled channels 336A and 336B. In some examples, arms 332A and 332B can be pivotally or rotatably connected via a hinge mechanism or the like. In some examples, arms 332A and 332B can be rotated such that angled channels 336A and 336B are brought closer together. Thus, portions of arms 332A and 332B forming angled channels 336A and 336B can be rotated toward each other to grasp or push tissue to be stapled. In some examples, arms 332A and 332B can be manually rotated, such as by using a scissor mechanism operated by a tension string or cable. In some examples, arms 332A and 332B can be electrically rotated using one or more motors operable from the proximal end of the scope.

[0109] The aligned channel 334A may be aligned coaxially with the drive block 314A, and the aligned channel 334B may be aligned coaxially with the drive block 314B. The diagonal channel 336A may be diagonal with respect to the axis of the drive block 314A, and the diagonal channel 336B may be diagonal with respect to the axis of the drive block 314B. The drive body 316A may be flexible to extend between the aligned channel 334A and the diagonal channel 336A. The drive body 316B may be flexible to extend between the aligned channel 334B and the diagonal channel 336B. Thus, the drive bodies 316A and 316B can be drawn into the aligned channels 334A and 334B so as to be completely straight. The drive blocks 314A and 314B can be driven forward within the aligned channels 334A and 334B so as to push the drive bodies 316A and 316B at least partially into the diagonal channels 336A and 336B. The drive bodies 316A and 316B can change their shape while extending in and out of the diagonal channels 336A and 336B. Thus, the drive bodies 316A and 316B or portions thereof can be aligned with the stitching element 318 when disposed within the diagonal channels 336A and 336B. The diagonal channels 336A and 336B are shown as straight segments disposed at an angle of approximately 90 degrees with respect to the aligned channels 334A and 334B. However, the diagonal channels 336A and 336B may be disposed at other angles and may be curved.

[0110] Coils 312A and 312B can be actuated to alternately act on hammers 302A and 302B to reciprocate the stitching element 318. Coil 312A can be actuated to push the stitching element 318 towards arm 332B. The distal tip of the driver 316A can include a cup-shaped feature or socket for receiving the tip 338A of the stitching element 318 to prevent the sharp tip used to penetrate tissue from becoming dull or blunted. A stopper 342A can be used to prevent the drive block 314A from moving too far within the angled channel 336A, such as within arm 332A. The stitching element 318 can be pushed through tissue by the direct drive of the driver 316A and the energy from the drive block 314A. Thus, the driver 316A can have approximately the same diameter as the stitching element 318 or a diameter smaller than the stitching element 318 so as to be pushed through the hole in the tissue created by the stitching element 318. In other examples, the driver 316A does not subsequently enter the tissue, and the stitching element 318 can continue to penetrate the tissue via the propulsive force. Thus, the stitching element 318 can be pushed into arm 332B. A spring 342A can be used to contract the driver 316A and return it within arm 332A. Within arm 332B, the stitching element 318 can engage the driver 316B. The distal tip of the driver 316B can include a cup-shaped feature or socket for receiving the tip 338B of the stitching element 318 to prevent the sharp tip used to penetrate tissue from becoming dull or blunted. Coil 312B can be actuated to push the stitching element 318 towards arm 332A. A stopper 342B can be used to prevent the drive block 314B from moving too far within the angled channel 336B, such as within arm 332B. A spring 342B can be used to contract the driver 316A and return it within arm 332A.

[0111] Suturing device 330 can be used to move hammers 302A and 302B using any of the electromagnetic devices described herein for electromagnetically pushing and pulling hammers 302A and 302B and / or for mechanically pushing and pulling hammers 302A and 302B. Further, suturing device 330 can include closure devices 259 and 278 described herein for attaching an anchor or other immobilization feature to the suture material.

[0112] FIG. 23 is a schematic cross-sectional view of an electromagnetic suturing mechanism 400 of the present disclosure including magnetically driven shuttles 402A and 402B. The suturing mechanism 400 can include a first arm 404A and a second arm 404B that respectively form channels 406A and 406B. Coils 408A and 408B can be respectively disposed on arms 404A and 404B, and springs 410A and 410B can be respectively disposed within channels 406A and 406B to interact with shuttles 402A and 402B. The suturing mechanism can further include a suturing element 412, which can include a body 414, notches 415A and 415B, tips 416A and 416B, and a connector 418 for connecting to suture material 420. Shuttles 402A and 402B can include lumps 422A and 422B, and jaws 424A and 424B. Jaw 424A can include a hinge 426A, an extension 428A, and teeth 430A, and jaw 424B can include a hinge 426B, an extension 428B, and teeth 430B.

[0113] Arms 404A and 404B may be incorporated into the suturing device described herein and, thus, may be disposed within a device attachable to the end of a scope for pushing and pulling a suture element 412 through tissue. Coils 408A and 408B may be embedded in the material of arms 404A and 404B or may be covered with a suitable sheath or the like. Coils 408A and 408B may comprise copper windings through which an electric current can be passed to generate a magneto-electric field for driving respective masses 422A and 422B. In some examples, masses 422A and 422B may be made of ferromagnetic material.

[0114] Channels 406A and 406B may be respectively disposed within arms 404A and 404B for receiving suture element 412. Channels 406A and 406B may comprise suitable stoppers (not shown) to prevent shuttles 402A and 402B from being propelled out of arms 404A and 404B by the electromagnetic fields of coils 408A and 408B, respectively. Further, springs 410A and 410B, or other biasing elements, may be used to prevent shuttles 402A and 402B from moving out of channels 406A and 406B. Further, springs 410A and 410B may be used to retract shuttles 402A and 402B back into original arms 404A and 404B after propulsion by coils 408A and 408B.

[0115] The shuttle may be pushed and pulled from channels 406A and 406B to reciprocate suture element 412 through tissue in a manner similar to that described with reference to FIGS. 17A-17D. However, instead of the magneto-electric fields of coils 408A and 408B directly propelling suture element 412, the suture element is indirectly driven by shuttles 402A and 402B, which are directly driven by the magneto-electric fields of coils 408A and 408B. Shuttles 402A and 402B may be driven such that the propulsion force of masses 422A and 422B can be used to push suture element 412.

[0116] The suture element 412 can be disposed between opposing teeth 430A in the extension 428A. The teeth 430A can be disposed within the notch 415A to grip the suture element 412. The extension 428A can be rotated inwardly by interaction with the walls of channels 406A and 406B. The hinge 426A can be biased to open or spread the teeth 430A. Thus, when the shuttle 402A is propelled leftward in FIG. 23, the extension 428A can open forcefully to release the suture element 412. However, the propelling force of the suture element 412 will maintain the leftward propelling force of the suture element 412 passing through the tissue and entering the shuttle 402B. The shuttle 402B can wait to receive the suture element 412 with the extension 428B expanded to receive the suture element 412. Thus, the operations of shuttles 402A and 402B can be coordinated by a control unit 16 (FIG. 3) or the like to reciprocate the suture element 412. For example, 1) the shuttle 402A can be propelled leftward by the operation of the coil 408A to push the suture element leftward, 2) the coil 408B can be propelled rightward simultaneously to receive the suture element 412, 3) the coil 408B can be de-energized to retract into the channel 406B via the operation of the spring 410B, 4) the coil 408A can be maintained energized to hold the extension in a position to receive the suture element 412, 5) the coil 408B can be energized to push the suture element 412 forward into the shuttle 402A, and steps 1-5 can be repeated.

[0117] In a further example, the suture element 412 can be driven between the teeth 430A and 430B to spread the extensions 428A and 428B to allow the teeth 430A and 430B to enter the notches 415A and 415B. Thus, the shuttles 402A and 402B can be returned to a retracted position within the channels 406A and 406B to receive the suture element 412.

[0118] Considering what has been described so far, the suture element 412 can be passed through the tissue in order to draw the suture material 420 into the tissue. Since the suture element 412 need not interact magnetically with the magnetic fields of the coils 408A and 408B, the suture element 412 can be made of any desirable material suitable for suturing in a biological environment.

[0119] FIG. 24 is a block diagram showing a method 400 of suturing tissue using the scope, reinsertion sheath, and suture attachment of the present disclosure. The method 400 can include the use of not only the scope 102, reinsertion sheath 104, tissue separation device 106, and suture attachment 108 of FIGS. 1 and 2, but also any of the devices described herein.

[0120] In step 402, a patient can be evaluated for a medical procedure. In one example, it can be determined preoperatively that the patient's colon needs to be treated with a tissue collection device such as the tissue separation device 106 (FIG. 1). The treatment can include removal of diseased or other tissue. It can be determined preoperatively that tissue can be collected without the need to incise, cut, or puncture the patient's duct wall. Thus, it can be determined preoperatively that the procedure will not involve suturing. Thus, the preoperative plan may not involve attaching a suturing device such as the suturing device 108 (FIG. 1) to the scope used to perform the procedure such as the scope 102 (FIG. 1).

[0121] In step 404, the scope can be guided through the anatomical structure to the target tissue. An access portal or incision can be made in the patient's anatomical structure. In some examples, the scope 102 (FIG. 1) can be inserted into the patient and guided to the colon. The steering and guiding features of the scope 102 can be used to guide the distal end of the scope 102 to the target tissue. For example, the imaging capability can be used to visualize the anatomical structure including the intersection of anatomical ducts. The steering capability can be used to pivot the distal end of the scope 102 into the desired duct and into the target tissue within the desired duct.

[0122] In step 406, a part of the medical treatment may be performed. For example, a part of the treatment planned before the surgery in step 402 may be performed. The target tissue may be collected using the tissue separation device 106. The target tissue may include tissue that may be diseased or tissue that represents the patient's pathological condition. 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 collect, separate, and store the target tissue if necessary.

[0123] In step 408, the treatment being performed may be evaluated. For example, the total amount of the collected tissue may be evaluated to determine whether a sufficient amount has been collected. Also, the patient may be evaluated to determine whether all of the diseased tissue has been collected. During the evaluation procedure, the patient's anatomical structure may be reexamined to determine whether bleeding is occurring. If bleeding is occurring, it may be determined that the conduit wall of the anatomical structure has been punctured. Thus, it may be determined that the incision in the patient should be closed by a suturing device or the like. Thus, it may be determined that the scope 102 should be withdrawn from the anatomical structure to facilitate the insertion of the suturing device.

[0124] In step 410, while the scope 102 remains inserted within the patient's anatomical structure, a reinsertion sheath may be applied to the scope 102. As discussed herein, the reinsertion sheath 104 can be operated to expand the slit 126, such as by pulling the end faces of the flanges 128A and 128B (FIG. 7) apart circumferentially. Thus, the reinsertion sheath 104 can be moved radially on the proximal portion of the shaft 110 (FIG. 2) of the endoscope 102. The reinsertion sheath 104 can be relaxed to allow the end faces of the flanges 128A and 128B to be brought closer to each other. Further, the reinsertion sheath 104 can be axially expanded to be inserted into the anatomical structure. For example, the reinsertion sheath 104 can be changed from the compressed configuration of FIG. 8A to the expanded configuration of FIG. 8B to allow one of the ends 150 or 152 (FIG. 6) to slide along the scope 102 to reach the target anatomical structure. The reinsertion sheath 104 can be gently guided along the shaft 110 so as not to strike adjacent anatomical structures or features of the scope 102. An axial closure mechanism, such as the zipper closure mechanism 182 (FIG. 11) or the mating rail closure mechanism 191 (FIG. 12), can be used to close the slit 126. The axial closure mechanism can be used before or during the axial deployment of the reinsertion sheath.

[0125] In step 412, the scope can be withdrawn from the reinsertion sheath. For example, the scope 102 can be withdrawn from the anatomical structure through the reinsertion sheath 104. The reinsertion sheath 104 can remain within the anatomical structure to radially open and hold a passage or tunnel to the target anatomical structure.

[0126] In step 414, an attachment can be coupled to the withdrawn scope. The attachment that was determined to be used in step 408 can be assembled to the scope. For example, the suturing device 108 can be attached to the shaft 110 of the scope 102. Referring to FIG. 14, the shaft 204 of the scope 202 can be inserted into the channel 224 of the coupler 216 such that the end face 206 is proximate to the suturing body 218.

[0127] In step 416, the scope can be inserted into the reinsertion sheath together with the attachment device. The scope 102 including the suturing device 108 can be slid into the lumen 124 (FIG. 1) of the reinsertion sheath 104.

[0128] In step 418, the scope can be pushed into the reinsertion sheath so as to reach the target anatomical structure. The scope 102 can be inserted until the distal end face and the suturing device 108 reach the target anatomical structure at the distal end of the reinsertion sheath 104.

[0129] In step 420, the attachment device assembled to the scope in step 414 can be deployed for use. For example, the suturing housing 218 can be rotated at the hinge 225 from the stowed position of FIG. 15A to the deployed position of FIG. 15B. The suturing housing 218 can be made to have a smaller footprint in the stowed position to allow for easier insertion of the scope 102 through the reinsertion sheath 104. However, the suturing housing 218 can be extended distally of the scope 102 for use in the deployed position.

[0130] In step 422, another portion of the surgical procedure that was 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 electromagnetic coils described herein may be actuated to directly provide electromagnetic propulsion force to the suture element or to provide it to a hammer or shuttle configured to drive the suture element. Additionally, the tissue separation device 106 may be used with the scope 102 to remove additional tissue from the anatomical structure. The tissue separation device 106 may be inserted into the lumen 119 (FIG. 1) and extended out of the distal end of the shaft 110 while the suturing device 108 is attached to the shaft 110. Accordingly, the separators 138A and 138B may be disposed within the socket 230 of the suturing housing 218 for use.

[0131] Thereafter, method 400 can return to step 412 to remove the scope and attachment device, if necessary, and reinsert the scope with a different reattachment device, or can continue with step 424 to complete the surgery.

[0132] In step 424, the reinsertion sheath can be removed from the scope. For example, the reinsertion sheath 104 can be slid proximally along the shaft 110 of the scope 102 until removed from the anatomical structure. The reinsertion sheath 104 can be opened at the slit 126 so as to be pulled away from the scope 102.

[0133] In step 426, the scope can be removed from the anatomical structure. For example, the scope 102 can be withdrawn from the anatomical structure. Alternatively, the reinsertion sheath 104 and the scope 102 can be removed together, or the scope 102 can be removed first and the reinsertion sheath 104 can be removed second. Thereafter, the access portal within the patient can be appropriately closed.

[0134] Accordingly, method 400 illustrates an example of a method of performing a medical procedure using a scope that can be withdrawn from and reinserted into a patient's anatomical structure via a surgical reinsertion sheath that can be disposed around the endoscope. The scope can be withdrawn during surgery to attach an auxiliary device, such as a suturing device disclosed herein, to perform an ancillary procedure, such as suturing an incision determined during surgery. Thus, the need to empirically determine whether to use an auxiliary device, such as a suture attachment, can be deferred to a decision during surgery, thereby simplifying the pre-operative planning process. Changes to the procedure during surgery can be facilitated by the use of a reinsertion sheath that can be disposed around the shaft of the scope already placed within the patient's anatomical structure, such as through the use of an axially extending slit that extends along the reinsertion sheath. Changes to the procedure during surgery can be facilitated by the use of a suturing device that can be easily and securely attached to the scope and changed from a stowed position that facilitates guiding the scope to a deployed position that facilitates use of the suturing device with the scope. Accordingly, the devices and methods described herein can streamline medical procedures and promote better patient outcomes.

[0135] Various notes and examples Example 1 is a method of withdrawing an endoscope from a target position within an anatomical structure, the method comprising inserting the endoscope into an access portal within the anatomical structure to deliver a distal end portion of the endoscope to the target position; disposing a guide sheath around a proximal end portion of the endoscope; sliding the guide sheath along the endoscope to reach the distal end portion; and withdrawing the endoscope from the guide sheath and the anatomical structure.

[0136] In Example 2, the subject matter recited in Example 1 optionally includes reinserting the endoscope into the anatomical structure through the guide sheath to deliver the distal end portion to the target position.

[0137] In Example 3, the subject matter described in Example 2 optionally includes the step of attaching a device to the distal end portion before the step of reinserting the endoscope.

[0138] In Example 4, the subject matter described in Example 3 optionally includes a device comprising an electromagnetic suturing device.

[0139] In Example 5, the subject matter described in any one or more of Examples 1 to 4 optionally includes the step of arranging a guide sheath around the proximal end portion of the endoscope, which includes opening a slit extending axially along the sheath and arranging a guide sheath around the shaft of the endoscope disposed between the proximal end portion and the distal end portion.

[0140] In Example 6, the subject matter described in Example 5 optionally includes further closing the slit by engaging the opposing edges of the slit to close the slit in the step of arranging a guide sheath around the proximal end portion of the endoscope.

[0141] In Example 7, the subject matter described in Example 6 optionally includes the step of engaging the opposing edges of the slit by axially moving a shuttle along the shaft of the endoscope.

[0142] In Example 8, the subject matter described in any one or more of Examples 5 to 7 optionally includes the step of arranging a guide sheath around the proximal end portion of the endoscope by closing the slit by extending a door circumferentially so as to at least partially cover the slit.

[0143] In Example 9, the subject matter described in any one or more of Examples 5 to 8 optionally includes the step of arranging a guide sheath around the proximal end portion of the endoscope by axially expanding the guide sheath while it is arranged around the shaft of the endoscope.

[0144] In Example 10, the subject matter described in Example 9 optionally includes the step of axially expanding the guide sheath by expanding a coil spring extending axially along the insertion sheath.

[0145] In Example 11, the subject matter described in any one or more of Examples 9 to 10 optionally includes the step of axially expanding the guide sheath by expanding a plurality of cross-supports.

[0146] Example 12 is a system for attaching a suturing device to an in-situ endoscope during surgery, comprising an elongated tunnel body extending from a proximal end portion to a distal end portion, and an insertion sheath having a slit extending axially along the elongated tunnel body, and a suturing device connectable to the endoscope in a releasable manner.

[0147] In Example 13, the subject matter described in Example 12 optionally includes an insertion sheath by a closure mechanism for the sheath.

[0148] In Example 14, the subject matter described in Example 13 optionally includes a closure mechanism having a mating edge of the slit.

[0149] In Example 15, the subject matter described in any one or more of Examples 13 to 14 optionally includes a closure mechanism having a door that rotates circumferentially.

[0150] In Example 16, the subject matter described in any one or more of Examples 12 to 15 optionally includes an elongated tunnel body having an axially expandable and contractible skin.

[0151] In Example 17, the subject matter described in Example 16 optionally includes an expansion mechanism having a helical support structure extending axially along at least a portion of the elongated tunnel body of the insertion sheath.

[0152] In Example 18, the subject matter described in any one or more of Examples 16 to 17 optionally includes an extension mechanism including a plurality of rigid cross-supports arranged along a long tunnel body.

[0153] In Example 19, the subject matter described in any one or more of Examples 12 to 18 optionally includes a suturing device including an electromagnetic actuation mechanism.

[0154] In Example 20, the subject matter described in Example 19 optionally includes a suturing device including an annular coupler for attachment to the distal end of an endoscope and a suturing body for accommodating a motive suturing element.

[0155] In Example 21, the subject matter described in Example 20 optionally includes a hinge connecting the annular coupler and the suturing body.

[0156] In Example 22, the subject matter described in any one or more of Examples 20 to 21 optionally includes a suturing mechanism including an arcuate path for a motive suturing element.

[0157] In Example 23, the subject matter described in any one or more of Examples 20 to 22 optionally includes a suturing mechanism further including a first coil and a second coil within the suturing body, and the motive suturing element is configured to be directly driven by at least one magnetic field generated by the first coil and the second coil.

[0158] In Example 24, the subject matter described in Example 23 optionally includes that the motive suturing element is configured to reciprocate between the first coil and the second coil.

[0159] In Example 25, the subject matter described in any one or more of Examples 23 to 24 optionally includes a motive suturing element configured to circulate between the first coil and the second coil.

[0160] In Example 26, the subject matter described in any one or more of Examples 23 to 25 optionally includes a control device configured to selectively operate the first and second coils.

[0161] In Example 27, the subject matter described in any one or more of Examples 23 to 26 optionally includes a biasing element connected to the power-driven suturing element.

[0162] In Example 28, the subject matter described in any one or more of Examples 23 to 27 optionally includes a magnet attached to the power-driven suturing element to enhance the interaction with at least one magnetic field.

[0163] In Example 29, the subject matter described in any one or more of Examples 12 to 28 optionally includes a suturing device sized to fit within the passage of the elongated tunnel body.

[0164] In Example 30, the subject matter described in any one or more of Examples 12 to 29 optionally includes an endoscope connected to the suturing device and configured to fit within the elongated tunnel body.

[0165] Example 31 is a reinsertion sheath for an endoscope, comprising an elongated body having a proximal end portion, a distal end portion, and a skin extending axially between the proximal end portion and the distal end portion, and a slit extending along the shaft to enable circumferential expansion of the elongated body.

[0166] In Example 32, the subject matter described in Example 31 optionally includes a reinsertion sheath having a closure mechanism for the slit of the elongated body.

[0167] In Example 33, the subject matter described in Example 32 optionally includes a closure mechanism having a mating edge of the slit.

[0168] In Example 34, the subject matter described in any one or more of Examples 32 to 33 optionally includes a closure mechanism having a circumferentially rotating door.

[0169] In Example 35, the subject matter described in any one or more of Examples 31 to 34 optionally includes an elongate body having an axially adjustable support structure.

[0170] In Example 36, the subject matter described in Example 35 optionally includes an axially adjustable support structure having a coil spring extending axially along at least a portion of the elongate body of the reinsertion sheath.

[0171] In Example 37, the subject matter described in any one or more of Examples 35 to 36 optionally includes an axially adjustable support structure having a plurality of foldable cross-supports arranged along the elongate body.

[0172] In Example 38, the subject matter described in any one or more of Examples 31 to 37 optionally includes that the skin is made of a polymeric material.

[0173] In Example 39, the subject matter described in Example 38 optionally includes that the skin is made of a material including a webbing.

[0174] In Example 40, the subject matter described in any one or more of Examples 38 to 39 optionally includes that the skin is configured to be wrinkled and stretched.

[0175] Each of these non-limiting examples may be independent or may be combined in various substitutions or combinations with one or more of the other examples.

[0176] The foregoing detailed description includes references to the accompanying drawings that form a part of the detailed description. The drawings, by way of example, illustrate 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 illustrated or described. However, the inventors also contemplate examples in which only the elements illustrated or described are provided. Further, the inventors contemplate using any combination or permutation of the elements illustrated or described (or one or more aspects thereof) with respect to the specific examples (or one or more aspects thereof) illustrated or described herein or other examples (or one or more aspects thereof).

[0177] Where there is a conflict in usage between this document and any document incorporated by reference, the usage in this document prevails.

[0178] In this document, the terms "a" or "an" are used to include one or more, as is common in patent documents, regardless of any other instance, or the use of "at least one" or "one or more". In this document, the term "or" is used to mean a nonexclusive or, such that "A or B" includes "A without B", "B without A", as well as "A and B", unless otherwise indicated. In this document, the terms "including" and "in which" are used as plain English equivalents of the respective terms "comprising" and "wherein". Also, in the following claims, the terms "including" and "comprising" are unlimited, meaning that a system, device, article, composition, formulation, or process that includes additional elements after such terms in a claim still falls within the scope of that claim. Further, in the following claims, terms such as "first", "second", and "third" are used merely as labels and are not intended to impose numerical conditions on their objects.

[0179] The method examples described in this specification may be at least partially machine-implemented or computer-implemented. Some examples may include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform a method as described in the examples above. The implementation of such a method may include code such as microcode, assembly language code, high-level language code, and the like. 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 computer-readable media during execution or at other times such as etc. 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), and the like.

[0180] The above description is intended to be exemplary and not limiting. For example, the above examples (or one or more of their aspects) may be used in combination with each other. Other embodiments may be used by those skilled in the art who have considered the above description. The abstract is provided to enable the reader to quickly ascertain the essence 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 embodiments for carrying out the above invention, various features may be grouped to rationalize the present disclosure. This should not be construed as intending that any disclosed feature not claimed is essential to any of the claims. Rather, the subject matter of the invention may possibly not include all features of the particular embodiments disclosed. Accordingly, the following claims are incorporated herein by way of example or embodiment for carrying out the invention, each claim standing on its own as a separate embodiment, and such embodiments are intended to be combinable with each other in various combinations or permutations. The scope of the present invention should be determined in accordance with the appended claims and the full scope of equivalents to which such claims are entitled.

Explanation of Signs

[0181] 10 Endoscopic examination system 12 Imaging and control system 14 Endoscope, choledochoscope 16 Control unit 18 Output unit 20 Input unit 22 Light source unit 24 Fluid source 26 Suction pump 28 Insertion section 30 Functional section 32 Handle section 34 Cable section 36 Connector 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, End-Viewing Endoscope Camera Module 72 Housing 74 Treatment Unit, Working Channel 76 Fluid Outlet 78 Illumination Lens 80 Objective Lens 82 Lumen 84 Light Transmitter 87 Imaging Unit 88 Wiring 89 Fluid Line 100 Endoscope System, Endoscopic Examination System 102 Scope, Endoscope 104 Re-Insertion Sheath 106 Tissue Separation Device 108 Suturing Device, Suturing Attachment 110 Long Body, Shaft 112 Control Device 114 Grip 116 Control Knob 118 Connector 119 Lumen 120 Cable 122 Shaft 124 Lumen 126 Gap, Slit 128A Flange 128B Flange 130 Shaft 132 Tissue Separator 134 Control Device 136 Hinge 138A Separator 138B Separator 140 Connector 142 Suturing Body 144 Control Element 146 Lumen 148 Rotating door, rotatable door 150 Proximal end 152 Distal end 154 Outer surface 156 Undulation 160 Re-insertion sheath 162 Expandable support 164A Strut 164B Strut 165 Hinge 166 Body 167 First end 168 Second end 169 Slit 170 Re-insertion sheath 172 Spiral support member 176 Body, long shaft 177 End 178 End 179 Slit 180 Re-insertion sheath 182 Zipper closure mechanism 184 Shaft 185 Slit 186A Teeth 186B Teeth 187A First side 187B Second side 188 Shuttle 190 Re-insertion sheath 191 Engagement rail closure mechanism, re-insertion 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 First slot 197B Second slot 198 Magnetic member 199 Metal strip 200 Suture device 202 Endoscope, scope 204 Shaft, reinsertion sheath 206 End face, distal face 208 Working channel 210 Imaging component 212 Lighting component 214 Irrigation channel 216 Connector 218 Suture body, suture housing 220 Housing 222 Control element 224 Channel 225 Hinge 226A Arm, track 226B Arm, track 228A Suture track 228B Suture track 229A End face 229B End face 230 Socket, space 240 Electromagnetic suture mechanism, electromagnetic suture device 242 Suture element 244 Coil 244A First coil 244B Second coil 244C Third coil 246A Lead wire 246B Lead wire 248 Body 250A Tip 250B Tip 252 Small hole 254 Suture material 256 Winding 258 Spool 259 Closure device 260 Tissue 262 Incision 264A Tissue part 264B Tissue part 266 Anchor 266B Anchor 270 Electromagnetic suture mechanism 272 Suture element 274 Spring 278 Closure device 280 Electromagnetic sewing mechanism 282 Sewing element 284 Circular track 286A Magnetic element 286B Magnetic element 286C Magnetic element 288A Reverse barb 288B Reverse barb 288C Reverse barb 290 Electromagnetic sewing mechanism 292 Sewing element 296 Magnetic element 300 Electromagnetic sewing mechanism 300A Electromagnetic sewing mechanism 300B Electromagnetic sewing mechanism 302 Hammer 302A Hammer 302B Hammer 304 Sewing body 306 Arm 308 Hammer chamber 310 Sewing element chamber 312 Coil 312A Coil 312B Coil 314 Driving block 314A Driving block 314B Driving block 316 Driving body 316A Driving body 316B Driving body 318 Sewing element 320 Sewing material 322 Shoulder 324 End face 330 Sewing device 332A Arm 332B Arm 334A Aligned channel 334B Aligned channel 336A Diagonal channel 336B Diagonal channel 342A Stopper, spring 342B Stopper, spring 400 Electromagnetic sewing mechanism, method 402 Step 402A Shuttle 402B Shuttle 404 Step 404A First arm 404B Second arm 406 Step 406A Channel 406B Channel 408 Step 408A Coil 408B Coil 410 Step 410A Spring 410B Spring 412 Stitching element, step 414 Body, step 415A Notch 415B Notch 416 Step 416A Tip 416B Tip 418 Connector, step 420 Stitching material, step 422 Step 422A Mass 422B Mass 424 Step 424A Joe 424B Joe 426 Step 426A Hinge 426B Hinge 428A Extension 428B Extension 430A Tooth 430B Tooth A Axis A1 Central longitudinal axis, axis A2 Axis A3 Axis D1 Outer diameter D2 Inner diameter L Length, direction R Radial direction T Thickness

Claims

1. A system for attaching a suturing device to an in-situ endoscope during surgery, comprising: A flexible reinsertion sheath having a proximal end portion and a distal end portion, A long tunnel body extending from the proximal end portion to the distal end portion and defining an internal lumen for receiving an endoscope, and A slit extending axially along the long tunnel body to provide access to the internal lumen, A flexible insertion sheath comprising: A suturing device that can be detachably connected to the endoscope, Wherein the suturing device can be guided through the internal lumen, The long tunnel body is provided with a skin that can be expanded and contracted axially, The suturing device comprises an electromagnetic actuation mechanism, the system.

2. The system according to claim 1, wherein the flexible reinsertion sheath comprises a closure mechanism for the flexible reinsertion sheath.

3. The system according to claim 2, wherein the closure mechanism comprises a mating edge of the slit.

4. The system according to claim 2, wherein the closure mechanism comprises an arcuate door configured to rotate circumferentially.

5. The system according to claim 1, further comprising an expansion mechanism comprising a helical support structure extending axially along at least a portion of the long tunnel body of the flexible reinsertion sheath.

6. The system according to claim 1, further comprising an expansion mechanism comprising a plurality of rigid cross supports disposed along the long tunnel body.

7. The suturing device, An annular connector for attachment to the distal end of the endoscope, and A suturing body for accommodating a prime mover suture element, The system according to claim 1.

8. The system according to claim 7, further comprising a hinge connecting the annular connector and the suturing body.

9. The system according to claim 7, wherein the suturing body comprises an arcuate path for the prime mover suture element.

10. The suturing body further comprises a first coil and a second coil within the suturing body, and the prime mover suture element is configured to be directly driven by at least one magnetic field generated by the first coil and the second coil. The system according to claim 7.

11. The system according to claim 10, wherein the motive power suturing element is configured to reciprocate between the first coil and the second coil.

12. The system according to claim 10, wherein the motive power suturing element is configured to circulate between the first coil and the second coil.

13. The system according to claim 10, further comprising a control device configured to selectively activate the first and second coils.

14. The system according to claim 10, further comprising a biasing element coupled to the motive power suturing element.

15. The system according to claim 10, further comprising a magnet attached to the motive power suturing element to enhance interaction with the at least one magnetic field.

16. The system according to claim 1, wherein the slit allows the elongated tunnel body to expand radially so as to fit onto the endoscope.

17. The system according to claim 1, further comprising an endoscope configured to connect to the suturing device and fit within the elongated tunnel body, wherein the endoscope extends from a proximal handle section to a distal functional section, and wherein the flexible reinsertion sheath has a length extending from the proximal handle section to the distal functional section. The system according to claim 1.

18. A system for attaching a suturing device to an in - situ endoscope during surgery, comprising: a flexible reinsertion sheath comprising: an elongated tunnel body extending from a proximal end portion to a distal end portion and defining an internal lumen for receiving an endoscope, and a slit axially extending along the elongated tunnel body to provide access to the internal lumen, wherein the flexible reinsertion sheath further comprises: a suturing device connectable to the endoscope in a releasable manner, wherein the suturing device is guidable through the internal lumen, the system further comprising an endoscope configured to connect to the suturing device and fit within the elongated tunnel body, wherein the endoscope extends from a proximal handle section to a distal functional section, and wherein the flexible reinsertion sheath has a length extending from the proximal handle section to the distal functional section.

19. A reinsertion sheath for an endoscope, comprising: an elongated body having: a proximal end portion, a distal end portion, a lumen for receiving an endoscope, and A skin extending axially between the proximal end portion and the distal end portion, comprising a long body, a slit extending along the shaft to allow circumferential expansion of the long body, and comprising, the long body being a reinsertion sheath comprising a skin that is axially expandable and contractible.

20. The reinsertion sheath according to claim 19, comprising a closure mechanism for the slit of the long body.

21. The reinsertion sheath according to claim 20, wherein the closure mechanism comprises a mating edge of the slit.

22. The reinsertion sheath according to claim 20, wherein the closure mechanism comprises a door that rotates circumferentially.

23. The reinsertion sheath according to claim 19, wherein the long body comprises an axially adjustable support structure.

24. The reinsertion sheath according to claim 23, wherein the axially adjustable support structure comprises a coil spring extending axially along at least a portion of the long body of the reinsertion sheath.

25. The reinsertion sheath according to claim 23, wherein the axially adjustable support structure comprises a plurality of foldable cross-supports arranged along the long body.

26. The reinsertion sheath according to claim 19, wherein the skin is made of a polymeric material.

27. The reinsertion sheath according to claim 26, wherein the skin is made of a material including webbing.

28. The reinsertion sheath according to claim 26, wherein the skin is configured to be wrinkled and stretched.

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