Electrosuturing device for endoscopy and laparoscopy

Abstract

The electromagnetic suturing device comprises a body, a coil within the body, and a suturing element actuable by a magnetic field generated in the coil. The electromagnetic suturing device comprises a housing having a first arm with a first end face, a first suture track extending into the first end face, a second arm with a second end face opposite the first end face, a second suture track extending into the second end face, a coil within the first arm, and a suturing element actuable by the magnetic field generated by the coil to move from the first suture track to the second suture track. The electromagnetic hammer suturing device comprises a housing and a coil within the housing, a shuttle reciprocating within the housing by an electromagnetic field generated by the coil, and a suturing element actuated by the shuttle.

Description

[Technical Field]

[0001] Priority claims This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 155,072, filed March 1, 2021, and U.S. Provisional Patent Application No. 63 / 216,638, filed June 30, 2021, which are incorporated herein by reference in their entireties.

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

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

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

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

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

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

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

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

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

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

[0012] In one example, a 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 re-insertion 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, an electromagnetic suturing device may include a C-shaped housing including a first arm having a first end face, a first suture track extending into the first end face, a second arm having a second end face at least partially opposite the first end face, a second suture track extending into the second end face, a first coil embedded in the first arm, and a suturing element configured to be driven by a magnetic field generated by the first coil to move from the first suture track to the second suture track.

[0017] In one example, an electromagnetic hammer suturing device may include a housing, a first coil embedded in the housing, a first shuttle configured to be reciprocated within the housing by a magnetic field generated by the first coil, and a suturing element configured to be actuated by the first shuttle. [Brief explanation of the drawings]

[0018] [Figure 1] FIG. 1 is a schematic cross-sectional view of an endoscopic system including a scope, a re-insertion sheath, a tissue separation device, and a suture attachment in an exploded configuration, showing the lumens extending through the system. [Figure 2] 2 is a schematic diagram of the endoscopic system of FIG. 1 in an assembled state, showing a tissue separation device and suture attachment positioned at the distal end of the scope and a reinsertion sheath positioned around the scope. [Figure 3] FIG. 3 is a schematic diagram of an imaging and control system including a control unit connected to the scope of FIGS. 1 and 2. [Figure 4] FIG. 4 is a schematic diagram of the control unit of FIG. 3 connected to a scope. [Figure 5A]FIG. 5 is an end view of a camera module including optical and functional components suitable for use with the scope of FIGS. 1-4. [Figure 5B] 5B is a cross-sectional view taken along section 5B-5B of FIG. 5A, showing components of the camera module. [Figure 6] FIG. 1 is a schematic side view of a re-insertion sheath of the present disclosure showing a slit in the skin of the shaft. [Figure 7] 7 is a schematic cross-sectional view taken along section 7-7 of FIG. 6, showing the inner lumen of the reinsertion sheath. [Figure 8A] 7 is a schematic side view of the reinsertion sheath of FIG. 6 in a compressed state such that the skin is corrugated. [Figure 8B] 8B is a schematic side view of the reinsertion sheath of FIG. 8A in an extended state with the skin expanded. [Figure 9A] FIG. 7 is a schematic side view of the reinsertion sheath of FIG. 6 with the expandable support in a compressed state. [Figure 9B] FIG. 9B is a schematic side view of the reinsertion sheath of FIG. 9A in an extended state. [Figure 10A] 7 is a schematic side view of the reinsertion sheath of FIG. 6 with the helical support member in a compressed state. [Figure 10B] FIG. 10B is a schematic side view of the reinsertion sheath of FIG. 10A in an extended state. [Figure 11] FIG. 1 is a schematic side view of one segment of the reinsertion sheath of the present disclosure having a zipper closure mechanism. [Figure 12A] FIG. 1 is a schematic side view of one segment of the reinsertion sheath of the present disclosure having a mating rail closure mechanism. [Figure 12B] 12B is a cross-sectional view taken along section 12B-12B of FIG. 12A showing the rails of the mating rail closure mechanism. [Figure 13] 1 is a schematic diagram of a re-insertion sheath having an elongate shaft with a lumen and a gap that can be closed by magnetic force. FIG. [Figure 14] FIG. 1 is a schematic perspective view of a suturing device attached to the distal end of an endoscope. [Figure 15A]15 is a schematic side view of the suturing device of FIG. 14 showing the suturing body rotated coplanar with the coupler via a hinge. [Figure 15B] 15 is a schematic side view of the suturing device of FIG. 14 showing the suturing body rotated away from the coupler via the hinge. [Figure 16] FIG. 1 is a schematic cross-sectional view of an electromagnetic suturing mechanism of the present disclosure comprising arcuate suturing elements disposed between arcuate tracks. [Figure 17A] FIG. 1 is a schematic illustration of an electromagnetic suturing device of the present disclosure passing a suturing element through tissue to draw suture material into the tissue to close the incision. [Figure 17B] FIG. 1 is a schematic illustration of an electromagnetic suturing device of the present disclosure passing a suturing element through tissue to draw suture material into the tissue to close the incision. [Figure 17C] FIG. 1 is a schematic illustration of an electromagnetic suturing device of the present disclosure passing a suturing element through tissue to draw suture material into the tissue to close the incision. [Figure 17D] FIG. 1 is a schematic illustration of an electromagnetic suturing device of the present disclosure passing a suturing element through tissue to draw suture material into the tissue to close the incision. [Figure 17E] FIG. 1 is a schematic illustration of an electromagnetic suturing device of the present disclosure passing a suturing element through tissue to draw suture material into the tissue to close the incision. [Figure 18] FIG. 1 is a schematic cross-sectional view of an electromagnetic suturing mechanism of the present disclosure comprising a magnetically actuated and spring-retracted suturing element. [Figure 19] 1 is a schematic cross-sectional view of an electromagnetic suturing mechanism of the present disclosure comprising a magnetically cycled suturing element; [Figure 20] 1 is a schematic cross-sectional view of an electromagnetic suturing mechanism of the present disclosure comprising a magnetically reciprocated suturing element; [Figure 21] 1 is a schematic cross-sectional view of an electromagnetic suturing mechanism of the present disclosure including a magnetically driven hammer; FIG. [Figure 22] 22 is a schematic cross-sectional view of the magnetically driven hammer of FIG. 21 in use with a suturing device having a straight arm. [Figure 23]1 is a schematic cross-sectional view of an electromagnetic suturing mechanism of the present disclosure including a magnetically driven shuttle; FIG. [Figure 24] FIG. 1 is a block diagram illustrating a method of suturing tissue using the scope, reinsertion sheath, and suturing attachment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0019] Figure 1 is a schematic diagram of an endoscopic system 100 in an exploded state. Figure 2 is a schematic diagram of the endoscopic system 100 of Figure 1 in an assembled state. Figures 1 and 2 will be discussed simultaneously. Figures 1 and 2 are not necessarily drawn to scale and may be exaggerated in some aspects for illustrative purposes.

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

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

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

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

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

[0025] 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 endoscopy system 100 may be configured to provide the ability to insert the scope 102, including the tissue separation device 106, into the anatomy and subsequently decide to assemble the suturing device 108 to the distal end of the scope 102. The reinsertion sheath 104 may be assembled to the shaft 110 of the scope 102 while the shaft 110 is inserted into the anatomy. The reinsertion sheath 104 may include various features to facilitate assembly with the proximal end of the shaft 110. For example, the reinsertion sheath 104 may include a slit 126 to allow the shaft 122 to be slid radially onto the shaft 110. Additionally, the reinsertion sheath 104 may include axial contraction and expansion capabilities to facilitate the assembly and insertion steps. Thus, the scope 102 may be withdrawn from the reinsertion sheath 104, assembled with the suturing device 108, and reinserted into the reinsertion sheath 104 with or without the tissue separation device 106.

[0027] Scope 102 may be configured as a fully functional endoscope, including steerability, navigation capabilities, imaging capabilities, fluid dispensing and withdrawal capabilities, and functional (e.g., therapeutic and diagnostic) capabilities, as well as a passageway for other instruments. The functionality of scope 102 is described in detail below with reference to endoscope 14 of Figures 3-5B and is therefore shown only diagrammatically in Figures 1 and 2.

[0028] Although the term "tissue separation device" is used throughout this disclosure, the tissue separation device 106 can alternatively or additionally comprise a biological material collection device, a biological material retrieval device, a tissue collection device, and a tissue retrieval device. The tissue separation device 106 can be configured as any suitable device configured to obtain, retrieve, collect, and / or remove a tissue sample from within a patient. The tissue separation device 106 can include components or devices for interacting with the patient, such as components or devices configured to cut, slice, pull, saw, punch, twist, or auger tissue or the like. Specifically, the tissue separation device 106 can include any device suitable for removing tissue from a patient, such as a blade, punch, or auger. The tissue separation device 106 can be configured to physically separate portions of the patient's tissue from other, larger portions of the patient's tissue. In a further example, the tissue separation device 106 can be configured to simply collect biological material from the patient that does not require physical separation, such as mucus or fluid that is already or naturally separated or distinct. In the example shown, tissue separating device 106 may comprise forceps having separators 138A and 138B configured as sharp or serrated jaws pivotally connected at hinge 136. However, tissue separating device 106 may be configured as a variety of devices capable of collecting biological material, such as a punch, an auger, a blade, a saw, etc., as mentioned. Tissue separating device 106 may be configured to retain a quantity of collected biological material, e.g., tissue, such as between separators 138A and 138B. Thus, tissue separating device 106 may be configured to be withdrawn from scope 102 to obtain the collected biological material, such as for diagnostic analysis or disposal.

[0029] FIG. 3 is a schematic diagram of an endoscopy system 10 comprising an imaging and control system 12 and an endoscope 14. The system of FIG. 3 is an illustrative example of an endoscopy system suitable for use with the systems, devices, and methods described herein, such as colonoscopy procedures, bariatric procedures, etc., which may be used to remove and obtain tissue or other biological material from a patient for analysis or treatment of the patient. According to some examples, the endoscope 14 may comprise the scope 102 of FIGS. 1 and 2 and may be insertable into an anatomical region for imaging and / or to facilitate the passage of one or more sampling devices for biopsies or one or more treatment devices for treatment of a medical condition associated with the anatomical region. The endoscope 14 may advantageously be in communication with and connected to the imaging and control system 12. In the example shown, the endoscope 14 comprises an end-viewing colonoscope, although other types of endoscopes may be used with the features and teachings of the present disclosure.

[0030] The imaging and control system 12 may include a control unit 16 , an output unit 18 , an input unit 20 , a light source unit 22 , a fluid source 24 , and a suction pump 26 .

[0031] The imaging and control system 12 may include various ports for coupling with the endoscopy system 10. For example, the control unit 16 may include a data input / output port for receiving data from and transmitting data to the endoscope 14. The light source unit 22 may include an output port for transmitting light to the endoscope 14, such as via a fiber optic link. The fluid source 24 may include a port for transmitting fluid to the endoscope 14. The fluid source 24 may include a pump and a tank of fluid or may be connected to an external tank, container, or storage unit. The suction pump 26 may include a port used to apply a vacuum to the endoscope 14 to generate suction, such as to draw fluid from the anatomical region into which the endoscope 14 is inserted. The output unit 18 and the input unit 20 may be used by an operator of the endoscopy system 10 to control the functions of the endoscopy system 10 and the view output of the endoscope 14. The control unit 16 may also be used to generate signals or other outputs for treating the anatomical region into which the endoscope 14 is inserted. In some examples, the control unit 16 can generate an electrical output, an acoustic output, a fluid output, etc. to treat an anatomical region by, for example, cauterizing, cutting, freezing, etc.

[0032] The endoscope 14 may include an insertion section 28, a function section 30, and a handle section 32 that may be coupled to a cable section 34 and a coupler section 36. The coupler section 36 may be connected to the control unit 16 to connect the endoscope 14 to multiple features of the control unit 16, such as the input unit 20, the light source unit 22, the fluid source 24, and the suction pump 26.

[0033] The insertion section 28 can extend distally from the handle section 32, and the cable section 34 can extend proximally from the handle section 32. The insertion section 28 can be elongated and can include a bending section and a distal end to which the functional section 30 can be attached. The bending section can be controllable (e.g., by a pull wire connected to a control knob 38 on the handle section 32) for maneuvering the distal end through a tortuous anatomical passageway (e.g., the stomach, duodenum, kidney, ureter, colon, etc.). The insertion section 28 can also include one or more working channels (e.g., internal lumens), which can be elongated and can aid in the insertion of one or more therapeutic tools of the functional section 30, such as the tissue separation device 106 of FIGS. 1 and 2. The working channels can extend between the handle section 32 and the functional section 30. Additional functionality, such as fluid passageways, guidewires, and pull wires, can also be provided by the insertion section 28 (e.g., via aspiration or irrigation passageways, etc.).

[0034] The handle section 32 can include a port 40A as well as a knob 38. The knob 38 can be coupled to a pull wire or other actuation mechanism extending through the insertion section 28. Port 40A, and other ports, such as port 40B (FIG. 2), can be configured to couple various electrical cables, guide wires, auxiliary scopes, tissue collection devices, fluid tubing, etc. to the handle section 32 for connection with the insertion section 28. For example, a tissue separation device 106 can be fed into the endoscope 14 through port 40A.

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

[0036] The functional section 30 can include components for treating and diagnosing a patient's anatomy. The functional section 30 can include imaging devices, illumination devices, and elevators. The functional section 30 can include imaging and illumination components configured for end viewing, e.g., for viewing distally or axially beyond the functional section 30, as further described with reference to the camera module 70 of FIGS. 5A and 5B.

[0037] FIG. 4 is a schematic diagram of the endoscopy system 10 of FIG. 3 , including an imaging and control system 12 and an endoscope 14. FIG. 4 schematically illustrates the components of the imaging and control system 12 coupled to the endoscope 14, which in the illustrated example comprises an end-viewing colonoscope. The imaging and control system 12 can include a control unit 16, which can include or be coupled to an image processing unit 42, a treatment generator 44, and a drive unit 46, in addition to the light source unit 22, the input unit 20, and the output unit 18. A coupler section 36 can be connected to the control unit 16 for connecting the endoscope 14 to multiple features of the control unit 16, such as the image processing unit 42 and the treatment generator 44. In some examples, the port 40A can be used to insert another instrument or device, such as a daughter scope or auxiliary scope, into the endoscope 14. Such instruments and devices can be independently connected to the control unit 16 via a cable 47. In some examples, ports 40B may be used to connect coupler 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., at the function section 30) via a wired or wireless electrical connection. Thus, the imaging and control system 12 can illuminate an anatomical region, collect signals representative of the anatomical region, process the signals representative of the anatomical region, and display images representative of the anatomical region on the output unit 18, which can comprise a cathode ray tube, an LCD display, an LED display, and other graphical user interfaces. The imaging and control system 12 can include the light source unit 22 to illuminate the anatomical region with a desired spectrum of light (e.g., broadband white light, narrowband imaging using preferred electromagnetic wavelengths, etc.). The imaging and control system 12 can be connected to the endoscope 14 (e.g., via an endoscope connector) for signal transmission (e.g., light output from a light source, video signals from the imaging system at the distal end, diagnostic and sensor signals from a diagnostic device, etc.).

[0039] Fluid source 24 (FIG. 1) can be in communication with control unit 16 and can include one or more sources of air, saline, or other fluids, as well as associated fluid paths (e.g., air channels, irrigation channels, aspiration channels) and connectors (barb fittings, fluid seals, valves, etc.). Imaging and control system 12 can also include a drive unit 46, which can be an optional component. Drive unit 46 can include a motorized drive for advancing the distal section of endoscope 14, as described at least in PCT Publication No. WO 2011 / 140118 A1 to Frassica et al., entitled "Rotate-to-Advance Catheterization System," which is incorporated herein by reference in its entirety.

[0040] Figures 5A and 5B show an example of the functional section 30 of the cholangioscope 14 of Figure 4. Figure 5A shows an end view of the functional section 30, and Figure 5B shows a cross-sectional view of the functional section 30 along cross-sectional plane 5B-5B of Figure 5A. Figures 5A and 5B each show an "end-viewing endoscope" (e.g., gastroscope, colonoscope, cholangioscope, etc.) camera module 70. In the end-viewing endoscope camera module 70, the illumination system and imaging system are positioned so that the viewing angle of the imaging system corresponds to a target anatomical structure located adjacent to (e.g., distal to) the end of the endoscope 14 and is coincident with the central longitudinal axis A1 of the endoscope 14.

[0041] 5A and 5B, end-viewing endoscopic camera module 70 may include housing 72, treatment unit 74, fluid outlet 76, illumination lens 78, and objective lens 80. Housing 72 may include an end cap for insertion section 28, thereby providing a seal for lumen 82.

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

[0043] Endoscopic camera module 70 may also include photosensitive elements such as a charge-coupled device ("CCD") sensor or a complementary metal-oxide semiconductor ("CMOS") sensor. In either example, imaging unit 87 may be coupled (e.g., via a wired or wireless connection) to image processing unit 42 ( FIG. 4 ) for transmitting signals (e.g., video signals) from the photosensitive elements to image processing unit 42 representing images to be displayed on a display, such as output unit 18. In various examples, imaging and control system 12 and imaging unit 87 may be configured to provide output at a desired resolution suitable for an endoscopic procedure (e.g., at least 480p, at least 720p, at least 1080p, at least 4k UHD, etc.).

[0044] As described herein, the working channel 74 may be used to deliver a tissue separation device 106 to the target tissue. Additionally, a suturing device 108 may be disposed on the distal end portion of the housing 72 to provide suturing functionality distal to the illumination lens 78 and the objective lens 80. Additionally, a re-insertion sheath 104 may be disposed about the proximal insertion section 28 of the housing 72 to allow the endoscope 14 to be inserted into and withdrawn from the anatomy with no or minimal steering and guidance.

[0045] Figure 6 is a schematic side view of the reinsertion sheath 104 of the present disclosure, showing the slit 126 in the shaft 122. Figure 7 is a schematic cross-sectional view of the reinsertion sheath 104 of Figure 6, showing the internal lumen 124 extending within the shaft 122. The shaft 122 can include the slit 126 forming flanges 128A and 128B. In some examples, the shaft 122 can further include a revolving door 148. Figures 6 and 7 will be discussed simultaneously.

[0046] The shaft 122 can extend axially along an axis A from a first proximal end 150 to a second distal end 152. In the example shown, the flanges 128A and 128B can form end faces separated by a distance. In other examples, the flanges 128A and 128B can contact one another to form a continuous 360-degree circumference. In some examples, a rotatable door 148 can extend from a channel in one of the flanges 128A into a channel in the other of the flanges 128B. The rotatable door 148 can be opened to allow a scope to be placed inside the lumen 124 and then rotated closed to secure the scope therein.

[0047] The lumen 124 can extend between the proximal end 150 and the distal end 152. The lumen 124 can extend in a radial direction R from the axis A1. The wall of the shaft 122 can have a thickness T. The outer diameter D1 of the shaft 122 can be configured to fit within a desired anatomy. The inner diameter D2 of the shaft 122 can be sized to fit around the shaft 110 of the scope 102 (FIGS. 1 and 2). The shaft 122 is shown as having a length L, which can be compressed and expanded as desired in various examples, as shown in FIGS. 8A and 8B. The shaft 122 is not drawn to scale in FIG. 6 and, therefore, may be longer in the direction L than shown.

[0048] Shaft 122 may be fabricated from any suitable biocompatible material. In some examples, shaft 122 may be made of a polymeric material. The material of shaft 122 may allow reinsertion sheath 104 to be deformed through manipulation by an operator, such as a surgeon. For example, an operator of reinsertion sheath 104 can pull flanges 128A and 128B apart to allow scope 102 ( FIG. 1 ) to be positioned inside lumen 124. However, reinsertion sheath 104 may be configured to maintain rigidity when positioned within the anatomy to navigate the anatomy and guide instruments through lumen 124. Thickness T may be selected to allow reinsertion sheath 104 to be contracted or crumpled as shown in FIG. 8A but extended to provide a desired passageway through the anatomy. Thus, thickness T may be selected to allow an operator to manually retract or extend length L, but shaft 122 may be configured to maintain its shape once extended.

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

[0050] Figure 8A is a schematic side view of reinsertion sheath 104 of Figures 6 and 7 in a compressed state. Reinsertion sheath 104 can be compressed along axis A1 into the corrugated state of Figure 8A. Outer surface 154 of reinsertion sheath 104 can be compressed to form undulations 156 as the material of shaft 122 is wrinkled.

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

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

[0053] Figure 9A is a schematic side view of a reinsertion sheath 160 in a contracted state with an expandable support 162. Figure 9B is a schematic side view of the reinsertion sheath 160 of Figure 9A in an extended state. Figures 9A and 9B will be discussed simultaneously.

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

[0055] Struts 164A and 164B may comprise wires or bars embedded in or attached to the material of body 166 inside or outside of lumen 124. Struts 164A and 164B may comprise rigid or stiff members for radial and circumferential support of the material of body 166 relative to axis A1. Hinge 165 may comprise a pivot point to allow struts 164A and 164B to rotate relative to one another while maintaining contact to provide radial and circumferential support to body 166. Struts 164A and 164B may be configured to minimally affect the axial stiffness of reinsertion sheath 160.

[0056] The body 166 can include a skin over the expandable support 162 to provide a shaft structure. The skin can comprise a flexible polymeric sheet reinforced with webbing, such as a ripstop material. The body 166 can be configured to provide the desired axial stiffness to the reinsertion sheath 160.

[0057] Figure 9A shows struts 164A and 164B in a collapsed state in which the ends of struts 164A and 164B are close together, but as can be seen in Figure 9B, struts 164A and 164B can be opened by rotating at hinge 165 as reinsertion sheath 160 is expanded so that ends 167 and 168 are further apart compared to Figure 9A.

[0058] Thus, body 166 of reinsertion sheath 160 can be compressed by rotating posts 164A and 164B at hinge 165 to the state shown in FIG. 9A to facilitate assembly with the scope. When it is desired to deploy reinsertion sheath 160, the operator can pull body 166 circumferentially apart at slit 169 to allow sheath 160 to be placed over shaft 110 of scope 102. Specifically, folded reinsertion sheath 160 can be placed over the proximal end of shaft 110 while the distal end of shaft 110 is positioned within the patient's anatomy. Once placed over shaft 110, the operator can push the distal end of reinsertion sheath 160 along shaft 110 and into the patient's anatomy. As mentioned, the stiffness of body 166 can be such that an operator can unfurrow body 166 from the collapsed configuration, but as body 166 additionally increases in size, body 166 can maintain its specific shape under pressure from the anatomy. Struts 164A and 164B can provide radial stiffness to reinsertion sheath 160 to allow body 166 to resist the anatomy and to allow other devices and instruments, such as scope 102 (FIGS. 1 and 2), to be inserted therein. Thus, length L (FIG. 6) of reinsertion sheath 160 can be long enough to reach or approach the distal end of scope 102. Once reinsertion sheath 160 is deployed within the anatomy and fully extended or sufficiently extended to reach the end portion of scope 102, scope 102 can be withdrawn, and reinsertion sheath 160 can remain. Thus, inner diameter D2 (FIG. 7) can provide a body that forms a tunnel to the desired anatomy, so that scope 102 can be simply inserted into re-insertion sheath 160 to reach the desired anatomy without having to be independently navigated to the original anatomy.Thus, the scope 102 can be withdrawn from the anatomical structure through the reinsertion sheath 160 to attach one of the suturing devices described herein with reference to Figures 14-23, and then reinserted with the suturing device to reach the same anatomical structure.

[0059] Figure 10A is a schematic side view of a reinsertion sheath 170 in a contracted state, having a helical support member 172. Figure 10B is a schematic side view of the reinsertion sheath 170 of Figure 10A in an extended state. Figures 10A and 10B will be discussed simultaneously.

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

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

[0062] 9A and 9B, helical support member 172 can provide radial and circumferential stiffening to body 176 to provide support against anatomical pressures and to form a body that defines a tunnel for insertion of instruments. However, helical support member 172 can allow for axial expansion and contraction of body 176 such that the natural stiffness of body 176 can be utilized to allow axial contraction and expansion of reinsertion sheath 170 to enable deployment as described with reference to FIGS.

[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 opposed teeth 186A and 186B on either side of the slit 185 and a shuttle 188. The zipper closure mechanism 182 is not necessarily drawn to scale in FIG. 11. The reinsertion sheath 180 of FIG. 11 can be used in conjunction with any of the reinsertion sheaths described herein, such as reinsertion sheaths 104, 160, and 170. The zipper closure mechanism 182 can be configured to extend along any of the slits 126, 169, and 179.

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

[0065] Zipper closure mechanism 182 can be released to allow teeth 186A and 186B to separate. Reinsertion sheath 180 can then be placed around the shaft of the scope. Reinsertion sheath 180 can be inserted into the anatomy with first end 187A positioned distally so that it enters the anatomy first. As shaft 184 is pushed or fed distally into the anatomy, shuttle 188 can be pulled proximally to engage teeth 186A and 186B. Thus, shuttle 188 can be advanced to close shaft 184 as shaft 184 is expanded and fed further into the anatomy.

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

[0067] The first rail 195A and the second rail 195B may be mounted on the ends of the shaft 192 forming the slit 193 in an overlapping manner, as described with reference to FIG.

[0068] 12B is a cross-sectional view of the reinsertion sheath closure mechanism 191 of FIG. 12A. The mating rail closure mechanism 191 can include a first rail 195A and a second rail 195B. The first rail 195A can include a first protrusion 196A and a first slot 197A. The second rail 195B can include a second protrusion 196B and a second slot 197B. The protrusions 196A and 196B can include spherical heads, and each rail of the slots 197A and 197B can include inwardly oriented teeth configured to engage with the spherical heads. In one example, the mating rail closure mechanism 191 can be configured in accordance with U.S. Patent No. 7,137,736 to Pawloski et al., which is incorporated herein by reference in its entirety.

[0069] As shown in FIG. 12B , the ends of slit 193 can be pulled such that portions of shaft 192 overlap to allow slots 197A and 197B and protrusions 196A and 196B, respectively, to interact. Protrusion 196A and slot 197A can be placed in an overlapping configuration and compressed together by an operator to lock. Similarly, protrusion 196B and slot 197B can be placed in an overlapping configuration and compressed together by an operator to lock. In one example, a shuttle can be provided on mating rail closure mechanism 191 to facilitate compressing protrusions 196A and 196B with slots 197A and 197B and separating the aforementioned components. Either end 194A or 194B can be fed into the anatomy first.

[0070] FIG. 13 is a schematic diagram of the re-insertion sheath 104 comprising the elongate shaft 176 with 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 members 198 can be attracted to the metal strip 199 via magnetic force. Thus, in a resting state, the magnetic members 198 can pull the end of the elongate shaft 176 along the closed gap 126. However, the magnetic members 198 can be pushed away from the metal strip 199 to allow a device or object to radially enter the lumen 124. After the device or object enters the lumen 124, the magnetic members 198 can be pulled back to engage with the metal strip 199 via magnetic attraction. Thus, the sheath 104 can be easily slid over the elongate body 110 of the scope 102 while the scope 102 is inserted into the anatomy.

[0071] 6-13 illustrate examples of reinsertion sheaths of the present disclosure having various features that can be used together, separately, or in various combinations. The reinsertion sheath of the present disclosure can provide a body that forms a tunnel through an anatomical structure, which can guide another instrument inserted therein to a desired location. The reinsertion sheath can be placed within the anatomical structure using another instrument that has previously been guided (e.g., steered, pivoted, controlled, and manipulated to be pushed through desired anatomical features and conduits) to a target tissue site within the anatomical structure. Thus, the previously inserted instrument can function as a type of guiding feature, similar to a guidewire, to direct the reinsertion sheath to the target tissue site without actively guiding the reinsertion sheath or with minimal manipulation or cajoling. As discussed herein, the reinsertion sheath can be circumferentially openable to allow placement of the reinsertion sheath over the instrument radially relative to the axis of the instrument. Thus, the reinsertion sheath can be placed over the proximal end of the instrument while the distal end is positioned within the anatomical structure. The reinsertion sheath material can form a skin radially reinforced with wires or bars that is axially compressible, e.g., axially contracted or collapsed, to fit over only a portion of the instrument's length, e.g., the portion of the instrument not inserted into the anatomy. Thus, the reinsertion sheath can be more easily manipulated. Once positioned over the proximal portion of the inserted instrument, the reinsertion sheath can be expanded or unfolded to compress the distal portion of the reinsertion sheath into the patient's anatomy around the instrument. Axially collapsible support features can be used to provide radial rigidity to the reinsertion sheath to push the anatomy away from the central axis of the reinsertion sheath. Thus, when the guide instrument is removed from the reinsertion sheath, an open tunnel can be provided within the reinsertion sheath to provide a direct route to the target tissue site.

[0072] 14 is a schematic perspective view of a suturing 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 suturing device 200 can include a coupler 216, a suturing body 218, a housing 220, a control element 222, and a hinge 225. As discussed herein, the suturing body 218 can include a device for moving a suturing element, such as a needle, staple, shuttle, or the like, to pull and / or push suture material through tissue. In some examples, an electromagnetic drive device can be used to move an arcuate suturing needle via direct or indirect electromagnetic force. Although the suturing device 200 has been described as a device that can be detachably attached to the scope 202, in further examples, the suturing device 200 or its components (e.g., the suturing body 218, the housing 220, the control element 222, and the hinge 225) may be incorporated directly into the scope 202.

[0073] The coupler 216 can comprise a rigid or flexible body that facilitates coupling with the shaft 204. The coupler 216 can comprise an annular body having a channel 224 passing therethrough from one end to the other along axis A2. The shaft 204 can extend along axis A1 in the previous figures. The shaft 204 of the endoscope 202 can be sized to fit within the channel 224 in a concentric manner to retain 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 coupler 216 or can include a flange to prevent the coupler 216 from being pushed proximally along the shaft 204. Such a flange can ensure proper positioning of the suturing body 218 relative to the end face 206 to ensure that the suturing body 218 is within the field of view of the imaging component 210 and the illumination component 212. However, channel 224 can allow enough end face 206 to be exposed without interfering with working channel 208, imaging component 210, illumination component 212, and irrigation channel 214. Thus, coupler 216 can form a cap that can be releasably attached to shaft 204. Channel 224 and shaft 204 can further include features (not visible in FIG. 14 ) to facilitate rotational alignment between suturing device 200 and scope 202, such as to provide proper orientation between working channel 208, imaging component 210, illumination component 212, and irrigation channel 214 of scope 202 and socket 230 of suturing device 200. In some examples, the rotational alignment features can comprise axially extending channels extending into end face 206 at specific circumferential locations that can receive corresponding axially extending flanges on channel 224, or vice versa.

[0074] The suturing body 218 can extend distally of the coupler 216 so as to be positioned distally of and within the fields of view of the imaging component 210 and the illumination component 212. The suturing body 218 can be connected to the coupler 216 via a hinge 225. The suturing body 218 can include opposing arms 226A and 226B including suture tracks 228A and 228B, respectively. The opposing arms 226A and 226B can be positioned about a socket 230, which can form a space for receiving tissue for suturing. The suture tracks 228A and 228B can extend in an arcuate manner into end faces 229A and 229B, respectively, and can have a radius of curvature about an 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 the electromagnetic coils discussed herein. The control element 222 may be configured to extend along the exterior of the shaft 204 for coupling to the control unit 112 when the suturing device 200 is assembled with the scope 102. Thus, the reinsertion sheath 204 may be configured to fit around the control element 222 as shown in FIG. 2 . However, the control element 222 may extend further through a lumen within the shaft 204.

[0075] As discussed herein, the suturing body 218 can include electromechanical components capable of generating electromagnetic fields within and between the arms 226A and 226B to push and / or pull magnetic suturing elements, e.g., needles, between the suturing tracks 228A and 228B.

[0076] Figure 15A is a side schematic view of the suturing device 200 of Figure 14 showing the suturing body 218 rotated coplanar with the coupler 216 via the hinge 225. Figure 15B is a side schematic view of the suturing device 200 of Figure 14 showing the suturing body 218 rotated away from the coupler 216 via the hinge 225. Figures 15A and 15B will be discussed simultaneously.

[0077] A housing 220 may be disposed beneath the coupler 216 proximal to the suture body 218. The housing 220 may include control elements, such as electronics, a motor, and a power source, for the elements of the suture body 218. A control element 222 (FIG. 14) may extend proximally from the housing 220 to connect the suture body 218 to a control device. The housing 220 may further include a mass of suture material and components for tying or anchoring the suture material. The suture body 218 may be rotatably coupled to the coupler 216 via a hinge 225. A shaft 204 of the endoscope 202 (FIG. 14) may extend into the channel 224 of the coupler 216. A distal face 206 of the shaft 204 may be exposed distally outside the coupler 216 so that a space 230 is visible.

[0078] 15A, the scope 202 may be more easily navigated through the anatomy with the suture 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 may not interfere with the operation of the imaging and illumination components 210 and 212 for guidance purposes. However, a space 230 between the arms 226A and 226B may be positioned adjacent to the face 206 to allow the imaging and illumination components 210 and 212 to have visibility beyond the suture body 218.

[0079] 15B , once the suturing body 218 has been navigated to a desired location of the target tissue within the anatomy, it can be rotated at the hinge 225 to cause the arms 226A and 226B to extend outward 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 having to navigate the shaft 204. The suturing device 200 can include a motor to provide a rotational input to the suturing body 218 at the hinge 225. The motor can be connected to the control element 222 such that an operator of the scope 204 can selectively operate the motor to raise and lower the suturing body 218.

[0080] 16 is a schematic cross-sectional view of an electromagnetic suturing mechanism 240 of the presently disclosed suturing device 200, comprising an arcuate suturing element 242 disposed between arcuate tracks 228A and 228B, and a coil 244. Coil 244 may comprise leads 246A and 246B. Suture element 242 may comprise a body 248, tips 250A and 250B, and an eyelet 252. Suture element 242 may be connected to suture material 254. A winding 256 of suture material 254 may be stored on a spool 258. A closure device 259 may be disposed on suturing device 200 to receive suture material 254 from spool 258. The closure device 259 may be configured to attach components (e.g., anchors) to the suture material 254 or to impart features (e.g., knots) to the suture material 254 to enable the suture material to be fastened onto tissue.

[0081] As discussed with reference to Figures 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 Figures 18-20, the suture element 242 can be moved between tracks 228A and 228B via various electromagnetic and mechanical actions to reciprocate or cycle 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 coupler 216, which may be coaxial with axis A1 of shaft 204 of scope 202 (FIG. 14).

[0082] In the example of FIG. 16 , power may be provided from control element 222 to coil 244 through leads 246A and 246B. Coil 244 may comprise copper windings onto which the material of arm 226A is molded. Control element 222 may be coupled to a power source at hinge 225 or proximal to control unit 16. Power may be passed through coil 244 to generate an electromagnetic field. The electromagnetic field may be configured to propel suturing element 242 from track 228A toward track 228B. Thus, tip 250B may penetrate tissue and pull suture material 254 through the tissue. Suture material 254 may be attached to suture element 242 at eyelet 252, which may comprise a bore or another feature to which suture material 254 may be attached. As suture element 242 is moved, suture material 254 may be pulled from spool 258. Spool 258 may be rotatably mounted within hinge 225, suture body 218, or housing 220. Suture element 242 may be fully pushed into track 228B. As discussed herein, suturing element 242 may be returned to track 228A via various electromagnetic or mechanical actions, such as direct electromagnetic impulse from a coil in arm 226B, reverse electromagnetic impulse from coil 244, mechanical force from arm 226A, or mechanical force from arm 226B. Tip 250A may allow suturing element 242 to penetrate tissue upon returning to 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 include a ball of polymeric material secured on the suture material 254. In a further example, the closure device 259 can include staples that press the suture material 254 against tissue or tacks that fasten to the suture material 254.

[0084] The suture element 242 can include 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 eyelet 252 is shown centrally located in the body 248. However, the eyelet 252 may be located elsewhere, 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 magnetized. The body 248 can also be made of a biocompatible and / or bioabsorbable material.

[0085] 17A-17D are schematic illustrations of the electromagnetic suturing device 240 of FIG. 16 passing a suture element 242 through tissue 260 to draw suture material 254 through the tissue 260 and close the incision 262. The incision 262 may be formed between tissue portions 264A and 264B of the tissue 260. The tissue 260 may be a vessel wall of an anatomical passageway. The incision 262 may be an unwanted perforation through the vessel wall that may be closed to prevent bleeding. In another example, the tissue portions 264A and 264B may comprise portions of a stomach wall that are sutured together to reduce stomach size in an obesity procedure. For simplicity, not all elements of the electromagnetic suturing device 240 and the suturing device 200 are shown in each of FIGS. 17A-17D.

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

[0087] In FIG. 17B, suture element 242 may be positioned within tissue 260. Suture material 254 may include anchors 266. Anchors 266 may be dispensed by closure device 259 ( FIG. 16 ) as suture material 254 is pulled from spool 258 ( FIG. 17A ). Closure device 259 may simultaneously sever suture material 254 from other windings of suture material 256 on spool 258. Thus, one length of suture material 254 may be provided to close incision 262. Suture material 254 may be attached to suture element 242 via eyelet 252 and a knot or another suitable attachment feature.

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

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

[0090] 17E, suturing device 200 may be operated to tighten suture material 254. Electromagnetic or mechanical force may be generated to push or pull suture material 254 to remove slack in suture material 254 shown in FIG. 17B between tissue 260 and anchor 266. Suture element 242 may be advanced until anchor 266 engages tissue 260. Thus, incision 262 between tissue portions 264A and 264B of incision 262 may be pulled into engagement. At such point, suture material 254 may be released from suture element 242. In some examples, one or both of arms 226A and 226B (FIG. 17A) may include a blade or another device for severing suture material 254 from suture element 242. 18, another closure device 278 (FIG. 18) may be provided between arms 226A and 226B to act on suture material 254 to prevent it from exiting rearwardly from tissue 260. For example, another anchor 266 may be applied to the end of suture material 254. In a further example, suture element 242 may be left in tissue 260 and allowed to dissolve or be reabsorbed into the anatomy.

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

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

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

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

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

[0096] In some examples, coils 244A and 244B can be activated to generate magnetic pushing and pulling forces on suturing element 282. Thus, coil 244A can be activated to similarly push suturing element 282 toward arm 226B (clockwise force), and coil 244B can be simultaneously activated to generate another magnetic force (clockwise force) to pull suturing element 282 into arm 226B. Once suturing element 282 enters arm 226B and is properly positioned relative to coil 244B (e.g., past coil 244B), coil 244B can be switched to generate a magnetic pushing force (clockwise force), and coil 244A can be switched to generate a magnetic pulling force (clockwise). The activation of coils 244A and 244B can be programmed and adjusted to maximize the motive force applied to suturing element 282. In one example, 1) coil 244A is actuatable to generate a pushing force and coil 244B is actuatable to generate a pulling force, 2) coil 244B is actuatable to generate a pushing force, 3) coil 244A is actuatable to generate a pulling force, and 4) steps 1)-3) are repeated. Coil 244C can similarly be actuated to switch between pulling and pushing suturing element 282 as the suturing element approaches and moves away from coil 244C.

[0097] Body 248 can include magnetic elements 286A-286C, which can comprise a magnetic material capable of interacting with the magnetic field generated by coils 244A and 244B. Magnetic elements 286A-286C can be configured to have a magnetic field that opposes the magnetic field generated by coils 244A and 244B. Thus, when coils 244A and 244B are actuated, suturing element 282 can be further propelled by the interaction of magnetic elements 286A-286C with the magnetic fields of coils 244A and 244B. In some examples, coil 244A can be configured to generate a magnetic field with a north pole N1 on the top and a south pole S1 on the bottom with respect to the orientation of Figure 19, coil 244B can be configured to generate a magnetic field with a north pole N2 on the bottom and a south pole S1 on the top with respect to the orientation of Figure 19, and magnetic elements 286A-286C can be configured to generate a magnetic field with a north pole N3 on the bottom and a south pole S on the top with respect to the orientation of Figure 19. In some examples, magnetic elements 286A-286C can be made of a diamagnetic material that is repelled by magnetic fields.

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

[0099] In some examples, circular track 284 may be configured in the shape of an infinity symbol. Accordingly, circular track 284 may be rotated along axis A2 such that track 226A moves further into the plane of FIG. 19 and track 226B moves further out of the plane of FIG. 19. A second portion of track 284 may be superimposed thereon to intersect track 284 along axis A2 proximal to spool 258, but may be rotated such that the track corresponding to track 226A moves further out of the plane of FIG. 19 and the track corresponding to track 226B moves further into the plane of FIG. 19. Accordingly, suturing element 282 may be configured to move out of the plane of FIG. 19 to provide a three-dimensional suture to tissue.

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

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

[0102] 19. Thus, magnetic element 296 can be propelled by the electromagnetic field generated by coils 244A and 244B. In some examples, magnetic element 296 can be made of a diamagnetic material that is repelled by the magnetic field.

[0103] 21-23 show additional examples of electrosuturing devices. The devices of FIGS. 21-23 may be particularly suited for use in laparoscopic procedures, but may also be used in other procedures, such as endoscopic procedures. For example, laparoscopic procedures may involve the use of an incision in the anatomy to insert a scope. Such an incision can accommodate larger instruments compared to, for example, a transorally inserted scope. Exemplary laparoscopic procedures include removal of the gallbladder (cholecystectomy), appendectomy, hernia repair, removal of a portion of the colon (colectomy) or small intestine, surgery for acid reflux (fundoplication), removal of the adrenal glands, and removal of the spleen. Some of these procedures may involve making an internal incision or cut that can be closed with sutures. In some cases, it may be advantageous to press two tissues together to engage them for suturing. Thus, laparoscopes may be more robust and may involve the use of pivotable jaws to grasp tissue for suturing, as discussed below.

[0104] 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 comprising an arm 306, a hammer chamber 308, a suturing element chamber 310, and a coil 312. The hammer 302 can comprise a driving mass 314 and a driver 316. A suturing element 318 can be connected to a suture material 320.

[0105] The suture body 304 may comprise a portion of the suture body 218 ( FIG. 14 ). The suture body 304 may define a hammer chamber 308 and a suture element chamber 310. The hammer chamber 308 may be configured to slidably receive a driver mass 314. The driver mass 314 may comprise a mass of material having a large mass relative to the mass of the suture element 318 to facilitate the transfer of kinetic energy from the hammer 302 to the suture element 318. The driver 316 may extend from the driver mass 314 into the suture element chamber 310. The suture element chamber 310 may be configured to slidably receive the driver 316. The suture element chamber 310 and the driver 316 may be radially smaller than the driver mass 314 and the hammer chamber 308 to form a shoulder 322. Thus, the end face 324 of the driver mass 314 can abut against 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 penetrate into the suturing element chamber 310 to contact the suturing 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 it to the right. The face 324 of the driver mass 314 can strike the shoulder 322, but the suture element 318 can continue to move to the right. Thus, the suture element 318 can be threaded through tissue by impulsive force. In other examples, the driver 316 can be longer so as to directly push 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 suturing body 304 can electromagnetically push the suturing element 318 to the left.

[0107] In some examples, the driver 316 can comprise a rigid, solid body capable of coaxially aligning with the suturing element 318 and the suturing element chamber 310. In further examples, the driver 316 can be curved or arcuate to work with a correspondingly curved suturing element chamber 310 and suturing element 318. In some examples, the driver 316 can be flexible to work with an example of a suturing element chamber 310 that is angled relative to the central axis of the hammer 302. In some examples, the driver mass 314 can be made of a metal such as steel, and the driver 316 can be made from a plastic such as PVC, polyethylene, PPEK, and polypropylene. Thus, the metal component can be made of a denser material to provide the driving force, and the plastic component can be made to flex as needed to guide the suturing element.

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

[0109] Aligned channel 334A may be coaxially aligned with drive mass 314A, and aligned channel 334B may be coaxially aligned with drive mass 314B. Diagonal channel 336A may be oblique to the axis of drive mass 314A, and diagonal channel 336B may be oblique to the axis of drive mass 314B. Driver 316A may be flexible to extend between aligned channel 334A and diagonal channel 336A. Driver 316B may be flexible to extend between aligned channel 334B and diagonal channel 336B. Thus, drivers 316A and 316B may be retracted into aligned channels 334A and 334B to become completely straight. Driver masses 314A and 314B can be driven forward within aligned channels 334A and 334B to at least partially push drivers 316A and 316B into diagonal channels 336A and 336B. Drivers 316A and 316B can change shape while extending into and out of diagonal channels 336A and 336B. Thus, drivers 316A and 316B, or portions thereof, can align with suturing element 318 when positioned within diagonal channels 336A and 336B. Diagonal channels 336A and 336B are shown as straight segments positioned at approximately 90-degree angles relative to aligned channels 334A and 334B. However, diagonal channels 336A and 336B may be positioned at other angles or may be curved.

[0110] Coils 312A and 312B can be actuated to alternately act on hammers 302A and 302B to reciprocate suturing element 318. Coil 312A can be actuated to push suturing element 318 toward arm 332B. The distal tip of driver 316A can include a cup-shaped feature or socket to receive tip 338A of suturing element 318 to prevent the sharp tip used to penetrate tissue from becoming dull or blunt. Stop 342A can be used to prevent driver mass 314A from traveling too far within arm 332A, such as into diagonal channel 336A. Suture element 318 can be pushed through tissue by the direct drive of driver 316A and energy from driver mass 314A. Thus, the driver 316A can have approximately the same diameter as or a smaller diameter than the suture element 318 so that it can be pushed through the hole in the tissue created by the suture element 318. In other examples, the driver 316A does not continue into the tissue, and the suture element 318 can continue to penetrate the tissue via the driving force. Thus, the suture element 318 can be pushed into the arm 332B. A spring 342A can be used to retract the driver 316A and return it to the arm 332A. Within the arm 332B, the suture element 318 can engage with the driver 316B. The distal tip of the driver 316B can include a cup-shaped feature or socket to receive the tip 338B of the suture element 318 to prevent the sharp tip used to penetrate the tissue from becoming dull or blunt. The coil 312B can be actuated to push the suture element 318 toward the arm 332A. A stopper 342B may be used to prevent the driver mass 314B from moving too far within the arm 332B, such as into the diagonal channel 336B. A spring 342B may be used to retract the driver 316A back into the arm 332A.

[0111] The suturing device 330 can be used to move the hammers 302A and 302B using any of the electromagnetic devices described herein to electromagnetically push and pull the hammers 302A and 302B and / or to mechanically push and pull the hammers 302A and 302B. Additionally, the suturing device 330 can include the closure devices 259 and 278 described herein to attach anchors or other fixation features to the suture material.

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

[0113] Arms 404A and 404B may be incorporated into a suturing device described herein and thus may be disposed within a device attachable to the end of a scope for pushing and pulling suturing element 412 through tissue. Coils 408A and 408B may be embedded in the material of arms 404A and 404B or may be covered by 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 masses 422A and 422B, respectively. In some examples, masses 422A and 422B may be made of a ferromagnetic material.

[0114] Channels 406A and 406B may be disposed within arms 404A and 404B, respectively, for receiving suturing element 412. Channels 406A and 406B may be provided with suitable stops (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. Additionally, 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. Additionally, springs 410A and 410B may be used to retract shuttles 402A and 402B back into arms 404A and 404B after being propelled by coils 408A and 408B.

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

[0116] The suture element 412 can be positioned between opposing teeth 430A on the extension 428A. The teeth 430A can be positioned within the notch 415A to grasp the suture element 412. The extension 428A can be rotated inward by interaction with the walls of the channels 406A and 406B. The hinge 426A can be biased to open or spread the teeth 430A. Thus, when the shuttle 402A is urged leftward in FIG. 23 , the extension 428A can snap open to release the suture element 412. However, the propulsive force of the suture element 412 will maintain the leftward propulsion of the suture element 412 through the tissue and into the shuttle 402B. The shuttle 402B can wait to receive the suture element 412 with the extension 428B spread open to receive the suture element 412. Thus, the operation of shuttles 402A and 402B can be coordinated, such as by control unit 16 (FIG. 3), to reciprocate suturing element 412. For example, 1) shuttle 402A can be urged leftward by operation of coil 408A to push the suturing element leftward, 2) coil 408B can be simultaneously urged rightward to receive suturing element 412, 3) coil 408B can be de-energized to retract into channel 406B via operation of spring 410B, 4) coil 408A can remain energized to hold the extension in position to receive suturing element 412, and 5) coil 408B can be energized to push suturing element 412 forward into shuttle 402A, and steps 1-5 can be repeated.

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

[0118] With the foregoing in mind, the suture element 412 may be threaded through tissue to draw the suture material 420 into the tissue. Because the suture element 412 does not need to magnetically interact with the magnetic fields of the coils 408A and 408B, the suture element 412 may be made of any desired material suitable for suturing in a biological environment.

[0119] 24 is a block diagram illustrating a method 400 of suturing tissue using the scope, reinsertion sheath, and suture attachment of the present disclosure. Method 400 may involve the use of the scope 102, reinsertion sheath 104, tissue separation device 106, and suture attachment 108 of FIGS. 1 and 2, as well as any of the devices described herein.

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

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

[0122] In step 406, a portion of the medical procedure may be performed. For example, a portion of the procedure pre-operatively planned in step 402 may be performed. Target tissue may be harvested using the tissue separation device 106. The target tissue may include tissue that may be diseased or that represents a pathological condition in the patient. For example, the separators 138A and 138B may be operated from the control device 134 to engage the target tissue one or more times to harvest, separate, and, if necessary, store the target tissue.

[0123] In step 408, the procedure being performed may be evaluated. For example, the total amount of tissue harvested may be evaluated to ensure a sufficient amount has been harvested. The patient may also be evaluated to determine whether all of the diseased tissue has been harvested. During the evaluation procedure, the patient's anatomical structure may be reexamined to determine whether bleeding has occurred. If bleeding has occurred, it may be determined that a vessel wall of the anatomical structure has been punctured. Therefore, it may be determined that the incision in the patient should be closed, such as with a suturing device. Therefore, it may be determined that the scope 102 should be withdrawn from the anatomical structure to facilitate insertion of the suturing device.

[0124] In step 410, a reinsertion sheath may be applied to scope 102 while it remains inserted within the patient's anatomy. As discussed herein, reinsertion sheath 104 may be manipulated to enlarge slit 126, such as by circumferentially separating the end faces of flanges 128A and 128B (FIG. 7). Accordingly, reinsertion sheath 104 may be moved radially over the proximal portion of shaft 110 (FIG. 2) of endoscope 102. Reinsertion sheath 104 may be relaxed to allow the end faces of flanges 128A and 128B to be brought closer together. Additionally, reinsertion sheath 104 may be axially expanded for insertion into the anatomy. For example, reinsertion sheath 104 may be shifted from the compressed configuration of FIG. 8A to the expanded configuration of FIG. 8B to allow one of ends 150 or 152 (FIG. 6) to be slid along scope 102 to reach the target anatomy. The reinsertion sheath 104 can be gently guided along the shaft 110 to avoid interfering with adjacent anatomical structures or features of the scope 102. An axial closure mechanism, such as a zipper closure mechanism 182 (FIG. 11) or a mating rail closure mechanism 191 (FIG. 12), can be used to close the slit 126. The axial closure mechanism can be used before or during axial deployment of the reinsertion sheath.

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

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

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

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

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

[0130] In step 422, another portion of the surgical procedure planned in step 402 and evaluated in step 408 may be performed. For example, the suturing device 108 may be used to close the incision and stop bleeding. Any of the various electromagnetic coils described herein may be activated to provide electromagnetic motive force directly to the suturing element or to a hammer or shuttle configured to drive the suturing element. Additionally, the tissue separating device 106 may be used with the scope 102 to remove additional tissue from the anatomical structure. The tissue separating device 106 may be inserted into the lumen 119 ( FIG. 1 ) and extended out the distal end of the shaft 110 while the suturing device 108 is attached to the shaft 110. Thus, separators 138A and 138B may be positioned within the socket 230 of the suture housing 218 for use.

[0131] Method 400 can then return to step 412 to remove the scope and attachment device and reinsert the scope with a different reattachment device, if desired, or can continue to step 424 to complete the procedure.

[0132] In step 424, the reinsertion sheath may be removed from the scope. For example, the reinsertion sheath 104 may be slid proximally along the shaft 110 of the scope 102 until it is removed from the anatomy. The reinsertion sheath 104 may be opened at the slit 126 so that it can be pulled away from the scope 102.

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

[0134] Thus, method 400 illustrates an example of a method for performing a medical procedure using a scope that can be withdrawn from and reinserted into a patient's anatomy via an intraoperative reinsertion sheath that can be positioned around the in situ scope. The scope can be withdrawn intraoperatively to perform an adjunctive procedure, such as suturing an intraoperatively determined incision, with the attachment of an auxiliary device, such as a suturing device disclosed herein. Preoperative planning can thus be simplified, as the need to a priori decide whether or not to use an auxiliary device, such as a suture attachment, can be postponed to an intraoperative decision. Intraoperative procedure changes can be facilitated by the use of a reinsertion sheath that can be placed around the shaft of a scope already placed within the patient's anatomy, such as through the use of an axially extending slit extending along the reinsertion sheath. Intraoperative procedure changes can be facilitated by the use of a suturing device that can be easily and securely attached to the scope and changed from a retracted position, which facilitates scope navigation, to a deployed position, which facilitates use of the suturing device with the scope. Thus, the devices and methods described herein can facilitate medical procedures and promote better patient outcomes.

[0135] Various notes and examples Example 1 is an electromagnetically driven suturing device comprising a body, a first coil embedded in the body, and a suturing element configured to be actuated by a magnetic field generated by the first coil.

[0136] In Example 2, the subject matter described in Example 1 optionally includes a body comprising a first arm having a first end face and a second arm having a second end face at least partially opposite the first end face, wherein the first coil is disposed within the first arm such that a central axis of the first coil extends from the first end face.

[0137] In Example 3, the subject matter described in Example 2 optionally includes a central axis of the first coil extending transversely relative to a central axis of the scope.

[0138] In Example 4, the subject matter of any one or more of Examples 2-3 optionally includes a cap rotatably connected to the base, the cap configured to be attached to a scope.

[0139] In Example 5, the subject matter described in any one or more of Examples 2-4 optionally includes a biasing element coupled to the suturing element.

[0140] In Example 6, the subject matter described in any one or more of Examples 2-5 optionally includes a second coil disposed within the second arm such that its central axis extends from the second end surface.

[0141] In Example 7, the subject matter described in Example 6 optionally includes a suturing element configured to reciprocate between the first coil and the second coil.

[0142] In Example 8, the subject matter described in Example 7 optionally includes coils configured to push or pull a suturing element.

[0143] In Example 9, the subject matter described in any one or more of Examples 6-8 optionally includes a suturing element configured to circulate between the first coil and the second coil.

[0144] In Example 10, the subject matter described in FIG. 9 optionally includes a third coil, the center of each coil being spaced 120 degrees from the other coil.

[0145] In Example 11, the subject matter of any one or more of Examples 6-10 optionally includes a controller configured to selectively activate the first and second coils.

[0146] In Example 12, the subject matter described in any one or more of Examples 6-11 optionally includes a magnet attached to the suturing element to enhance interaction with a magnetic field.

[0147] In Example 13, the subject matter described in any one or more of Examples 6-12 optionally includes a suturing element configured to be directly driven by a magnetic field.

[0148] In Example 14, the subject matter described in any one or more of Examples 6-13 optionally includes a suturing element indirectly driven by a magnetic field.

[0149] In Example 15, the subject matter described in Example 14 optionally includes a first shuttle configured to interact with a magnetic field to drive the suturing element.

[0150] In Example 16, the subject matter described in Example 15 optionally includes a first shuttle comprising a hammer configured to strike the suturing element.

[0151] In Example 17, the subject matter described in Example 16 optionally includes a hammer comprising a mass configured to slide within the first arm and a tip extending from the mass configured to strike the suturing element.

[0152] In Example 18, the subject matter of any one or more of Examples 15-17 optionally includes a first shuttle comprising a carriage configured to be attached to a suturing element.

[0153] In Example 19, the subject matter described in Example 18 optionally includes a carriage comprising a socket for receiving a suturing element and a gripper element for securing the suturing element in the socket.

[0154] In Example 20, the subject matter described in any one or more of Examples 1-19 optionally includes a means for immobilizing suture material embedded in tissue by the suturing element.

[0155] Example 21 is an electromagnetic suturing device comprising a C-shaped housing having a first arm having a first end face, a first suture track extending into the first end face, a second arm having a second end face at least partially opposite the first end face, a second suture track extending into the second end face, a first coil embedded in the first arm, and a suture element configured to be driven by a magnetic field generated by the first coil to move from the first suture track to the second suture track.

[0156] In Example 22, the subject matter described in Example 21 optionally includes a suture element that is arcuate, a first suture track, and a second suture track.

[0157] In Example 23, the subject matter described in any one or more of Examples 21-22 optionally includes a biasing mechanism attached to the suturing element to counteract the force generated by the magnetic field.

[0158] In Example 24, the subject matter of any one or more of Examples 21-23 optionally includes a suturing element comprising a magnet to facilitate engagement with a magnetic field.

[0159] In Example 25, the subject matter described in any one or more of Examples 21-24 optionally includes a suture element comprising an interlocking feature for suture material located proximal to a center of the suture element.

[0160] In Example 26, the subject matter described in any one or more of Examples 21-25 optionally includes a body comprising a second coil embedded in the second arm to facilitate reciprocating movement of the suturing element.

[0161] In Example 27, the subject matter described in any one or more of Examples 21-26 optionally includes a body comprising a third coil embedded in the first or second arm to facilitate circulation of the suturing element around the C-shaped housing.

[0162] In Example 28, the subject matter of any one or more of Examples 21-27 optionally includes a first suture track comprising a circular arc segment.

[0163] In Example 29, the subject matter described in Examples 21-27 optionally includes a first suture track having the shape of an infinity symbol.

[0164] In Example 30, the subject matter of any one or more of Examples 21-29 optionally includes a suturing element comprising barbs to facilitate unidirectional sliding of the suturing element.

[0165] Example 31 is an electromagnetic hammer suturing device comprising a housing, a first coil embedded in the housing, a first shuttle configured to be reciprocated within the housing by an electromagnetic field generated by the first coil, and a suturing element configured to be actuated by the first shuttle.

[0166] In Example 32, the subject matter described in Example 31 optionally includes a housing comprising a first arm having a first end surface, wherein a first coil is disposed within the first arm, a first suture track extending into the first end surface, and a second arm having a second end surface at least partially opposite the first end surface.

[0167] In Example 33, the subject matter described in Example 32 optionally includes a second suture track extending into the second end face, a second coil embedded in the second arm, and a second carriage positioned within the second suture track and configured to be actuated by a second magnetic field generated by the second coil.

[0168] In Example 34, the subject matter described in any one or more of Examples 31-33 optionally includes a first shuttle comprising a hammer configured to strike the suturing element.

[0169] In Example 35, the subject matter described in Example 34 optionally includes a hammer having a mass configured to slide within the first arm and a tip extending from the mass configured to strike the suturing element.

[0170] In Example 36, the subject matter of any one or more of Examples 31-35 optionally includes a first shuttle comprising a carriage configured to be attached to a suturing element.

[0171] In Example 37, the subject matter described in any one or more of Examples 34-36 optionally includes a carriage having a socket for receiving a suturing element and a gripper element for securing the suturing element in the socket.

[0172] Each of these non-limiting examples can stand alone or can be combined in various permutations or combinations with one or more of the other examples.

[0173] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as "examples." Such examples may include elements in addition to those shown or described. However, the inventors also contemplate examples in which only those elements shown or described are provided. Furthermore, the inventors contemplate the use of any combination or permutation of the illustrated or described elements (or one or more aspects thereof) with a particular example (or one or more aspects thereof) or other examples (or one or more aspects thereof) shown or described herein.

[0174] If there is a conflicting usage between this document and any document incorporated by reference, the usage in this document will control.

[0175] In this document, the terms "a" or "an" are used to include one or more, regardless of any other examples or the use of "at least one" or "one or more," as is common in patent documents. In this document, the term "or" is used to mean a nonexclusive or, unless otherwise indicated, such that "A or B" includes "A excluding B," "B excluding A," and "A and B." In this document, the terms "including" and "in which" are used as the plain-English equivalents of the respective terms "comprising" and "wherein." Also, in the following claims, the terms "including" and "comprising" are open-ended, i.e., systems, devices, articles, compositions, formulations, or processes that include elements in addition to those recited after such terms in a claim are still construed as falling within the scope of that claim. Moreover, in the following claims, the terms "first," "second," and "third," etc., are used merely as labels and are not intended to impose numerical requirements on their objects.

[0176] The example methods described herein may be at least partially machine- or computer-implemented. Some examples may include a computer-readable or machine-readable medium encoded with instructions operable to configure an electronic device to perform a method such as described in the above examples. An implementation of such a method may include code such as microcode, assembly language code, high-level language code, etc. Such code may include computer-readable instructions for performing various methods. The code may form part of a computer program product. Further, in one example, the code may be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media, such as during execution or at other times. Examples of such tangible computer-readable media may include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or memory sticks, random access memory (RAM), read-only memory (ROM), etc.

[0177] The above description is intended to be illustrative and not limiting. For example, the above examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments may be employed by those of ordinary skill in the art upon review of the above description. The Abstract is provided to enable the reader to quickly ascertain the nature of the technical disclosure. The Abstract is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be construed as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may not include all features of a particular disclosed embodiment. Accordingly, the following claims are incorporated into the Detailed Description herein as examples or embodiments, and it is intended that each claim stand on their own as a separate embodiment, and that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full range of equivalents to which such claims are entitled. [Explanation of symbols]

[0178] 10 Endoscopy System 12 Imaging and Control System 14 Endoscopy, Cholangioscopy 16 Control Unit 18 Output Units 20 input units 22 Light source unit 24 Fluid source 26 Suction pump 28 Insert Section 30 Function Section 32 Handle Section 34 Cable Section 36 Coupler Section 38 Control knob, knob 40A port 40B port 41 Cart 42 Image Processing Unit 44 Treatment Generator 46 Drive Unit 47 Cable 70 Camera Module 72 Housing 74 Treatment Unit, Working Channel 76 Fluid outlet 78 Lighting Lens 80 objective lenses 82 Lumen 84 Light transmitter 87 Imaging unit 88 Wiring 89 Fluid Line 100 Endoscope system, endoscopy system 102 Scopes, endoscopes 104 Reinsertion Sheath 106 Tissue Separation Device 108 Suturing devices, suture attachments 110 Long body, shaft 112 Control device 114 Grip 116 Control Knob 118 Coupler 119 Lumen 120 Cable 122 Shaft 124 Lumen 126 Gap 126 Slit 128A flange 128B flange 130 shaft 132 Tissue Separator 134 Control Devices 136 Hinge 138A Separator 138B Separator 140 Coupler 142 Sutured Body 144 Control Elements 146 Lumen 148 Revolving door, revolving door 150 proximal end 152 distal end 154 Outer surface 156 undulations 160 Reinsertion Sheath 162 Expandable Support 164A Post 164B Post 165 hinge 166 Body 167 First End 168 Second End 169 Slit 170 Reinsertion Sheath 172 Spiral support member 176 body, long shaft 177 End 178 End 179 Slit 180 Reinsertion Sheath 182 Zipper Closure Mechanism 184 shaft 185 slit 186A Teeth 186B Teeth 187A First Side 187B Second Side 188 Shuttle 190 Reinsertion Sheath 191 Interlocking rail closure mechanism, reinsertion sheath closure mechanism 192 shaft 193 Slit 194A First End 194B Second end 195A First Rail 195B Second Rail 196A First protrusion 196B Second protrusion 197A 1st slot 197B Second Slot 198 Magnetic Components 199 Metal Strips 200 Suture Device 202 Endoscopes, scopes 204 Shaft, reinsertion sheath 206 End face, distal face 208 Working Channel 210 Imaging Components 212 Lighting Components 214 Irrigation Channel 216 Coupler 218 Suture body, suture housing 220 Housing 222 Control Elements 224 channels 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 elements 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 windings 258 spool 259 Closure Device 260 Organization 262 Cut 264A Tissue part 264B Tissue part 266 Anchor 270 Electromagnetic suturing mechanism 272 Suture elements 274 Spring 278 Closure Device 280 Electromagnetic suturing mechanism 282 Suture elements 284 circular track 286A magnetic element 286B Magnetic Element 286C magnetic element 288A Barbed 288B Barbed 288C Barbed 290 Electromagnetic suturing mechanism 292 Suture Elements 296 Magnetic elements 300 Electromagnetic suturing mechanism 300A electromagnetic suture mechanism 300B Electromagnetic suturing mechanism 302 Hammer 302A Hammer 302B Hammer 304 Suture Body 306 Arm 308 Hammer Room 310 Suture element chamber 310 312 Coil 312A coil 312B coil 314 Driving Mass 314A Driven Mass 314B Driven Mass 316 Driver 316A Driver 316B Driver 318 Suture Elements 320 Suture material 322 Shoulder 324 End face 330 Suture Device 332A Arm 332B Arm 334A Aligned Channels 334B Aligned Channels 336A Diagonal Channel 336B Diagonal Channel 342A Stopper, spring 342B Stopper, spring 400 Electromagnetic suturing mechanism and method 402 Step 402A Shuttle 402B Shuttle 404 Step 404A First Arm 404B Second Arm 406 Steps 406A Channel 406B channel 408 Steps 408A coil 408B coil 410 steps 410A spring 410B spring 412 Suture element, step 414 Body, Step 415A notch 415B Notch 416 steps 416A Tip 416B tip 418 Coupler, Step 420 Suture material, step 422 steps 422A Massive area 422B Massive part 424 steps 424A Joe 424B Joe 426 steps 426A Hinge 426B Hinge 428A Extension 428B Extension 430A teeth 430B Teeth 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. Body and a first coil embedded in the body; a suturing element configured to be actuated by electromagnetic impulse of a magnetic field generated by the first coil; An electromagnetically driven suturing device comprising:

2. The body a first arm having a first end surface; a second arm having a second end surface at least partially opposite the first end surface; Equipped with The electromagnetically driven suturing device of claim 1 , wherein the first coil is disposed within the first arm such that a central axis of the first coil extends from the first end face.

3. The electromagnetically driven suturing device of claim 2 , wherein the central axis of the first coil extends transversely to a central axis of a scope.

4. The electromagnetically driven suturing device of claim 2 , further comprising a cap rotatably connected to the base, the cap configured to be attached to a scope.

5. The electromagnetically driven suturing device of claim 2 , further comprising a biasing element coupled to the suturing element.

6. The electromagnetically driven suturing device of claim 2 , further comprising a second coil mounted within the second arm with its central axis extending from the second end face.

7. The electromagnetically driven suturing device of claim 6 , wherein the suturing element is configured to reciprocate between the first coil and the second coil.

8. The electromagnetically driven suturing device of claim 7 , wherein each coil is configured to push or pull the suturing element.

9. The electromagnetically driven suturing device of claim 6 , wherein the suturing element is configured to cycle between the first coil and the second coil.

10. The electromagnetically driven suturing device of claim 9, further comprising a third coil, the center of each coil being spaced 120 degrees from the other coil.

11. The electromagnetically driven suturing device of claim 6, further comprising a controller configured to selectively activate the first and second coils.

12. The electromagnetically driven suturing device of claim 6, further comprising a magnet attached to the suturing element for enhancing interaction with the magnetic field.

13. The electromagnetically driven suturing device of claim 6 , wherein the suturing element is configured to be driven by the magnetic field acting directly on the suturing element.

14. The electromagnetically driven suturing device of claim 6 , wherein the suturing element is indirectly driven by the magnetic field driven member.

15. The electromagnetically driven suturing device of claim 14, further comprising a first shuttle configured to interact with the magnetic field to drive the suturing element.

16. The first shuttle comprises: a hammer configured to strike the suture element The electromagnetically driven suturing device of claim 15, comprising:

17. The hammer a mass configured to slide within the first arm; a tip extending from the mass configured to abut against the suture element; The electromagnetically driven suturing device of claim 16, comprising:

18. The electromagnetically driven suturing device of claim 15, wherein the first shuttle is configured to be attached to the suturing element.

19. The electromagnetically driven suturing device of claim 18, wherein the first shuttle includes a jaw for securing the suturing element within a socket.

20. The electromagnetically driven suturing device of claim 1 , further comprising means for immobilizing suture material embedded in tissue by the suturing element.

21. a first arm having a first end surface; a first suture track extending into the first end face; a second arm having a second end surface at least partially opposite the first end surface; a second suture track extending into the second end face; and a first coil embedded in the first arm; a suturing element configured to be driven by electromagnetic propulsion of a magnetic field generated by the first coil to move from the first suture track to the second suture track; C-shaped housing comprising An electromagnetic suturing device comprising:

22. The electromagnetic suturing device of claim 21 , wherein the suturing element, the first suture track, and the second suture track are arcuate.

23. 22. The electromagnetic suturing device of claim 21, further comprising a biasing mechanism attached to the suturing element to counteract the force generated by the magnetic field.

24. The electromagnetic suturing device of claim 21 , wherein the suturing element comprises a magnet to facilitate engagement with the magnetic field.

25. 22. The electromagnetic suturing device of claim 21, wherein the suturing element includes a coupling structure proximal to a center of the suturing element for attaching suture material to the suturing element.

26. 22. The electromagnetic suturing device of claim 21, comprising a second coil embedded in the second arm to facilitate reciprocating movement of the suturing element.

27. 22. The electromagnetic suturing device of claim 21, comprising a third coil embedded in the first or second arm to facilitate circulation of the suturing element around the C-shaped housing.

28. The electromagnetic suturing device of claim 21 , wherein the first suture track comprises an arc segment.

29. The electromagnetic suturing device of claim 21 , wherein the first suture track has the shape of an infinity symbol.

30. 22. The electromagnetic suturing device of claim 21, wherein the suturing element comprises barbs to facilitate unidirectional sliding of the suturing element.

31. Housing and a first coil embedded in the housing; a first shuttle configured to be reciprocated within the housing by an electromagnetic field generated by the first coil; a suturing element configured to be actuated by the first shuttle; An electromagnetic hammer suturing device comprising:

32. The housing comprises: a first arm having a first end surface, the first coil being disposed within the first arm; a first suture track extending into the first end face; a second arm having a second end surface at least partially opposite the first end surface; 32. The electromagnetic hammer suturing device of claim 31, comprising:

33. a second suture track extending into the second end face; and a second coil embedded in the second arm; a second carriage disposed within the second suture track and configured to be actuated by a second magnetic field generated by the second coil; and 33. The electromagnetic hammer suturing device of claim 32, further comprising:

34. 32. The electromagnetic hammer suturing device of claim 31, wherein the first shuttle comprises a hammer configured to strike the suturing element.

35. A hammer configured to strike the suture element, The hammer a mass configured to slide within the first arm; a tip extending from the mass configured to abut against the suture element; 33. The electromagnetic hammer suturing device of claim 32, comprising:

36. 32. The electromagnetic hammer suturing device of claim 31, wherein the first shuttle comprises a carriage configured to be attached to the suturing element.

37. 35. The electromagnetic hammer suturing device of claim 34, wherein the first shuttle includes a jaw for securing the suturing element within a socket.

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