Traction system for endoscopic surgery and method of use thereof

Abstract

The present invention generally relates to the field of medical devices. In particular, the present invention relates to traction systems and methods of use for endoscopic procedures, such as tissue dissection. For example, a traction system may include a filament extendable along an outer surface of an endoscope, wherein the distal end of the filament is attachable to a medical device that engages target tissue in a body cavity.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority under 35 U.S.C. §119 to U.S. Provisional Patent Application No. 62 / 861,555, filed on June 14, 2019, the entire contents of which are incorporated herein by reference for all purposes. Technical Field

[0003] The present invention relates generally to the field of medical devices. In particular, the present invention relates to a traction system and method of use thereof for endoscopic surgery, such as tissue dissection. Background Art

[0004] Performing an endoscopic tissue resection / dissection procedure may include maintaining traction while dissecting the boundaries of the target tissue for accuracy and efficiency of the procedure. The physician may use a tethered system in which an endoscopic clip is attached to a length of filament extending outside the patient's body to retract / secure the target tissue for dissecting along the tissue edges and / or removing the dissected target tissue for biopsy.

[0005] In view of the foregoing considerations, improvements of the present invention may be useful. Summary of the Invention

[0006] In one aspect, the present invention relates to a system for use with an endoscope, comprising a cap attachable to a distal end (or a portion thereof) of the endoscope, the cap having a working channel extending therethrough. The cap may include a cavity coextensive with the working channel. A first guide may be attached to / mounted on an outer surface of the cap. A first filament may extend through the first guide and along the outer surfaces of the endoscope and the cap. A first endoscopic instrument may be disposed within the working channel. The distal end of the first filament may be attached to the distal end of the first endoscopic instrument.

[0007] In the described and other embodiments, the first endoscopic instrument may include a sheath, and the first medical device may be releasably attached to the distal end of the sheath. The first medical device may include a tissue clamp. The distal end of the first filament may be attached to an arm of the tissue clamp. A handle may be operably attached to the proximal end of the first endoscopic instrument. The handle may be configured to move the first medical device between first and second positions. The handle may be configured to release the first medical device from the distal end of the sheath. A flexible elongated shaft may extend along an outer surface of the endoscope and cap and through a first guide. The first filament may extend through the flexible elongated shaft. A handle assembly may be attached to the proximal end of the flexible elongated shaft. The handle assembly may include first, second, and third clamping elements. The first clamping element may be configured to advance and retract the flexible elongated shaft through the first guide. The second and third clamping elements may be attached to each other via a connector. The proximal end of the first filament may be attached to the connector.

[0008] In another aspect, the present invention relates to a system for use with an endoscope, comprising a cap attachable to a distal end (or a portion thereof) of the endoscope, the cap having a working channel extending therethrough. The cap may include a cavity coextensive with the working channel. A first guide and a second guide may be attached to / mounted on an outer surface of the cap. A first filament may extend through the first guide and along the outer surfaces of the endoscope and the cap. A first endoscopic instrument may be disposed within the working channel. The distal end of the first filament may be attached to the distal end of the first endoscopic instrument.

[0009] In the described and other embodiments, the first endoscopic instrument may include a sheath, and the first medical device may be releasably attached to the distal end of the sheath. The first medical device may include a tissue clamp. The distal end of the first filament may be attached to an arm of the tissue clamp. The second filament may extend through the second guide and along the outer surface of the endoscope and cap. The distal end of the second filament may be attached to the arm of the second medical device. The flexible elongated shaft may extend along the outer surface of the endoscope and cap and through the first guide. The first filament may extend through the flexible elongated shaft. The flexible elongated shaft may extend along the outer surface of the endoscope and cap and through the second guide. The second filament may extend through the flexible elongated shaft.

[0010] In another aspect, the present invention relates to a system for performing endoscopic surgery. The system may include a first guide member extendable along an outer surface of an endoscope. The guide member may be configured to be mounted on the endoscope or a portion of the endoscope (either a portion of the endoscope or formed separately and attached to / mounted on the endoscope). A first filament may extend through the first guide member and along the outer surface of the endoscope; and a first endoscopic instrument may be disposed within a working channel, wherein a distal end of the first filament may be attached to a distal end of the first endoscopic instrument.

[0011] In yet another aspect, the present invention relates to a method comprising advancing a first instrument through a working channel of an elongated tubular member and through a lumen of a cap attached to / mounted on a distal end of the elongated tubular member such that the distal end of the first instrument can extend distally beyond the distal end of the cap.

[0012] In the described and other embodiments, a medical device attached to the distal end of a first instrument can be moved from a closed position to an open position. The distal end of a filament extending along the outer surface of an elongated tubular member, and optionally, a cap, can be attached to an arm of the medical device. The filament can extend through a guide attached to / mounted on the outer surface of the elongated tubular member or the cap. The medical device can be moved from an open position to a closed position. The first instrument can be retracted so that the medical device can be positioned within the working channel of the elongated tubular member. The elongated tubular member can be advanced through a body cavity to position the distal end or cap of the elongated tubular member adjacent to target tissue. The medical device can be advanced distally beyond the distal end or cap of the elongated tubular member. The medical device can be moved from a closed position to an open position. The medical device can be moved from an open position to a closed position to engage target tissue. The medical device can be detached from the distal end of the first instrument. The proximal end of the filament can be retracted proximally to apply tension to the target tissue. The first instrument can be replaced with a second instrument within the working channel of the elongated tubular member. The target tissue can be manipulated using the medical device attached to the distal end of the second instrument. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Non-limiting embodiments of the present invention are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. In the drawings, each identical or nearly identical component shown is generally represented by a single numeral. For clarity, not every component is labeled in every figure, and not every component of every embodiment is shown unless necessary for one skilled in the art to understand the present invention. In the drawings:

[0014] Figures 1A to 1C A perspective view of an apparatus according to one embodiment of the present invention is provided.

[0015] Figure 2 A perspective view of a conventional tethered pulling system is provided.

[0016] Figure 3 A perspective view of a tether pulling system according to one embodiment of the present invention is provided.

[0017] Figure 4 A perspective view of a filament loop disposed about an arm of a medical device is provided in accordance with one embodiment of the present invention.

[0018] Figure 5 A perspective view of a tether pulling system according to one embodiment of the present invention is provided.

[0019] Figure 6 A perspective view of a tether pulling system according to one embodiment of the present invention is provided.

[0020] Figure 7A perspective view of a handle assembly of a flexible elongated shaft according to one embodiment of the present invention is provided.

[0021] Figure 8 A perspective view of a handle assembly of a flexible elongated shaft according to one embodiment of the present invention is provided. DETAILED DESCRIPTION

[0022] The present invention is not limited to the specific embodiments described herein. The terminology used herein is intended only to describe specific embodiments and is not intended to limit the scope of the appended claims. Unless otherwise specified, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0023] Although embodiments of the present invention are described with specific reference to endoscopic systems and methods designed to provide traction within the gastrointestinal tract during tissue dissection / resection procedures, it will be understood that such systems and methods may be used to manipulate various tissues within a variety of different body cavities and / or body passages, either in conjunction with or independently of an endoscope.

[0024] As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will also be understood that when used herein, the terms "comprises" and / or "includes" or "includes" and / or "includes" specify the presence of stated features, regions, steps, elements and / or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components and / or groups.

[0025] As used herein, the term "distal" refers to the end of the device farthest from the medical professional when introduced into a patient, and the term "proximal" refers to the end of the device closest to the medical professional when introduced into a patient.

[0026] refer to Figures 1A to 1C In one embodiment, a first endoscopic instrument 140 for use with the endoscopic systems 100, 200, 300, 400 of the present invention may include a handle 144 operably attached to the proximal end of a flexible elongated shaft 142 (e.g., a catheter, etc.) and a first medical device 146 releasably attached to the flexible elongated sheath 142. In one embodiment, the first medical device 146 may include a tissue clamp or clip including arms or jaws 146a, 146b configured to be in a first (e.g., open) position ( Figure 1A ) and a second (eg, closed) position ( Figure 1B). In various embodiments, in the second position, the arms or jaws 146a, 146b of the first medical device 146 can contact target tissue 148 within a body cavity, such as, for example, target tissue of the gastrointestinal (GI) tract. In various additional embodiments, the handle 144 can be further actuated to cause the first medical device 146 to be moved from the distal end ( Figure 1C ) is disengaged (e.g., released) such that the first medical device 146 can remain engaged with the target tissue 148 after the first endoscopic instrument 140 has been removed from the patient's body.

[0027] refer to Figure 2 In one embodiment, the endoscope system 100 can include a cap 120 (e.g., an endoscope cap, etc.) that can be attached (e.g., by a friction or interference fit, a threaded fit, a snap-lock fit, etc.) to a distal end 112 of a flexible, elongated tubular member 110 (e.g., an endoscope, etc.) having a proximal end (not shown), a distal end 112, and a lumen or working channel 114 extending therebetween. The lumen 124 defined by the cap 120 can be coextensive with (e.g., aligned with) the working channel 114. A first endoscopic instrument 140 can be movably / slidably disposed within the working channel 114 and the lumen 124 such that a first medical device 146 attached to a distal end of a sheath 142 of the first endoscopic instrument 140 can extend distally beyond the distal end of the cap 120, for example, to engage target tissue within a body cavity. A first filament 130 (e.g., a suture, thread, cord, etc.) can extend along the outer surface of the elongated tubular member 110 and the outer surface of the cap 120, and a distal end 132 of the first filament 130 can be attached to (e.g., tethered to) a portion of a first medical device 146, including, for example, arms 146a of the first medical device 146. In various embodiments, as discussed above, the first medical device 146 can be moved from a first position to a second position to engage target tissue with the first and second arms 146a, 146b and to disengage / release the first medical device 146 from the distal end of the sheath 142. The proximal end 136 of the first filament 130 can extend beyond the proximal end of the elongated tubular member 110 and outside the patient so that a medical professional can proximally retract the first filament 130 to apply tension / traction to the target tissue engaged with the first medical device 146.

[0028] refer to Figure 3In one embodiment, the endoscope system 200 of the present invention can include a cap 220 (e.g., an endoscope cap, etc.) that can be attached (e.g., by a friction or interference fit, a threaded fit, a snap-lock fit, etc.) to the distal end 212 of a flexible, elongated member 210 (e.g., an endoscope, etc.) having a proximal end (not shown), a distal end 212, and a lumen or working channel 214 extending therebetween. The lumen 224 defined by the cap 220 can be coextensive with (e.g., aligned with) the working channel 214. A first guide 226 (e.g., a filament guide, a suture guide, a tubular support, a ring, etc.) defining an open channel therethrough can be attached to / mounted on an outer surface of the cap 220. A first filament 230 (e.g., a suture, a thread, a string, or other flexible material, etc.) can extend along the outer surface of the elongated tubular member 210 and the outer surface of the cap 220 and through the channel of the first guide 226.

[0029] As discussed above, the first endoscopic instrument 140 can be movably / slidably disposed within the working channel 214 and the lumen 224 such that the first medical device 146 attached to the distal end of the first endoscopic instrument 140 can be extended distally beyond the distal end of the cap 220, for example, to engage target tissue. The distal end 232 of the first filament 230 can be attached (e.g., tethered, etc.) to the arm 146a of the first medical device 146. Subsequently, the first medical device 146 can be moved from the first position to the second position to engage the target tissue 148 and detach the first medical device 146 from the distal end of the sheath 142.

[0030] The proximal end 236 of the first filament 230 can extend beyond the proximal end of the slender tubular member 210 and outside the patient so that a medical professional can retract the first filament 230 proximally to apply tension / traction to the target tissue 148 engaged with the first medical device 146 along the longitudinal axis of the cap 220 via the first guide 226.

[0031] In use and by way of example, the endoscopic system 200 of the present invention can be assembled (e.g., prior to insertion into a patient) by attaching the cap 220 to the distal end 212 of the elongated tubular member 210. Subsequently, the first endoscopic instrument 140 can be advanced through the working channel 214 of the elongated tubular member 210 and through the lumen 224 of the cap 220, such that the first medical device 146 attached to the distal end of the sheath 142 of the first endoscopic instrument 140 can be extended distally beyond the distal end of the cap 220. The handle 144 of the first endoscopic instrument can then be actuated to extend the first medical device 146 from the second position ( Figure 1B ) moves to the first position ( Figure 1A), for example, such that the arms 146a, 146b are opened / separated into a Y-shape. The first filament 230 can then be advanced through the open channel of the first guide 226 of the cap 220, and a loop 232 formed from the distal portion of the first filament 230 can be disposed around one of the arms 146a, 146b of the first medical device 146 ( Figure 4 ). In one embodiment, the loop 232 may include a sliding knot that is configured to tighten around the arm 146a when the filament 230 is retracted proximally. In some embodiments, the filament 230 can be directly or indirectly attached to the first medical device 146 by an adhesive, soldering, welding, brazing, or a mechanical attachment, such as a band, a clamp, or a ratchet, or a combination thereof. For example, the filament 230 can be looped around the first medical device 146 and secured by applying an adhesive to the filament itself. In some embodiments, the first medical device is provided with a hole, and one end of the filament 230 is passed through the hole and then expanded in diameter (e.g., by tying a knot, heat-staking the end of the filament, coupling another element to the end of the filament, etc.) to hold the end of the filament in place. The handle 144 of the first working instrument 140 can then be actuated to move the arms 146a, 146b of the first medical device 146 from the first position to the second position and the first endoscopic instrument 140 can be retracted proximally so that the first medical device 146 is disposed (e.g., protected, shielded, concealed, stowed, etc.) within the lumen 224 of the cap 220 and / or the working channel 214 of the elongated tubular member 210. The endoscopic system 200 can then be advanced through the patient's body cavity and positioned adjacent to the target tissue with the first medical device 146 disposed within the lumen 224 and / or working channel 214 and the first filament 230 secured to the arms 146a. The first endoscopic instrument 140 can then be advanced distally through the working channel 214 to position the first medical device 146 distally beyond the distal end of the cap 220. The handle 144 can then be actuated to move the arms 146a, 146b of the first medical device 146 from the second position to the first position and place the opened arms 146a, 146b in contact with the surface of the target tissue. The handle 144 can then be actuated to move the arms 146a, 146b from the first position to the second position to engage (e.g., clamp) the first medical device 146 with the target tissue. In some embodiments, the handle 144 can be actuated to disengage the first medical device 146 from the sheath 142 of the first endoscopic instrument 140. In some embodiments, the handle 144 can actuate the instrument 140 to engage tissue before and / or during a procedure.

[0032] In various embodiments, the first endoscopic instrument 140 can then be removed (e.g., withdrawn) from the working channel 214 of the elongated tubular member 210, and the second endoscopic instrument 150 can be advanced through the working channel to position a second medical device (e.g., an electrocautery, a resection tool, etc.) attached to the distal end of the second endoscopic instrument 150 distally beyond the distal end of the cap 220 and adjacent the target tissue 148. As discussed above, the proximal end 236 of the first filament 230 can extend beyond the proximal end of the elongated tubular member 210 and outside of the patient so that the medical professional can proximally retract the first filament 230 to apply tension / traction as the second medical device manipulates (e.g., dissects) the target tissue 148.

[0033] In one embodiment, the first medical device 146 can be engaged with the portion of the target tissue being dissected so that the target tissue can be taken out from the patient's body. Alternatively, the first medical device 146 can be engaged with the target tissue of the adjacent portion being excised. In such an embodiment, a physician or other medical professional can cut the first filament (e.g., using a second medical instrument) so that the first medical device 146 can remain in the body cavity after completing the medical procedure. The portion of the target tissue engaged by the separated first medical device 146 may eventually separate or fall off, and the first medical device 146 can be discharged / removed from the patient's body by the natural process of the body. Alternatively, the medical professional can retract the first filament toward the proximal end with enough force to disconnect (e.g., break) the first filament or disengage (e.g., pull out) the arm of the first medical device from the target tissue.

[0034] refer to Figure 5 In one embodiment, the endoscope system 300 of the present invention can include the same or similar elements as the endoscope system 200 and further includes a second guide 227 (e.g., a suture guide, a filament guide, a tubular support, a ring, etc.) attached to / mounted on the outer surface of the cap 220, the second guide 227 defining an open channel therethrough. Although the first and second guides 226, 227 are depicted as being positioned on substantially opposite sides of the cap 220, in various embodiments, the first and second guides 226, 227 can be attached to / mounted on the outer surface of the cap 220 at various longitudinal and / or axial positions relative to each other. Additionally or alternatively, additional guides (e.g., a third, fourth, fifth guide, etc.) can be attached to / mounted on the outer surface of the cap 220 in a variety of different patterns and / or configurations relative to each other.

[0035] In various embodiments, a second filament 231 (e.g., a suture, thread, cord, etc.) can be extended along the outer surface of the elongated tubular member 210 and the outer surface of the cap 220 and through the second guide 227 so that the distal end 233 of the second filament 231 can be attached to the arms 147a, 147b of the second medical device 147. In use and as an example, the endoscopic system 300 can be withdrawn from the patient with the first filament 230 extended through the channel of the first guide 226 and the first medical device 146 engaged with the target tissue 148. Then, by following the steps outlined above, the second medical device 147 can be attached to the distal end of the sheath 142 of the first endoscopic instrument 140, the arms 147a, 147b of the second medical device attached to the second filament 231, and the second medical device 147 positioned within the lumen 224 of the cap 220 and / or the working channel 214 of the elongated tubular member 210.

[0036] With the second medical device 147 disposed within the lumen 224 and / or working channel 214, and the second filament 231 secured to one of the arms 147a, 147b of the second medical device 147, the endoscopic system 300 can be reintroduced through the patient's body cavity with the distal end of the cap 220 repositioned adjacent the target tissue 148. As discussed above, the medical professional can then follow the steps described above with respect to the endoscopic system 200 to actuate the handle 144 to engage (e.g., clamp) a separate portion of the target tissue 148 with the second medical device 147, and subsequently disengage / release the second medical device 147.

[0037] The first endoscopic instrument 140 can be removed (e.g., withdrawn) again from the working channel 214 of the elongated tubular member 210, and the second endoscopic instrument 150 can be introduced / reintroduced through the working channel to reposition the second medical device attached to the distal end of the second endoscopic instrument adjacent the target tissue. The medical professional can then proximally retract the respective proximal ends 236, 237 of the first and second filaments 230, 231 as needed to apply a desired amount (e.g., force) and / or direction of tension / traction as the second medical device manipulates (e.g., dissects) the target tissue 148.

[0038] In one embodiment, the first and second filaments 230, 231 can include distinguishing features, such as unique color codes, so that medical professionals can visually identify which filament to retract and / or release to properly position the target tissue for manipulation by the second medical device. For example, when observing the target tissue through the elongated tubular member, a physician or other medical professional can identify the first filament 230 as a first color (e.g., blue) and the second filament 231 as a second color (e.g., red). The physician or other medical professional can then retract the proximal end of the first (e.g., blue) filament 230 to apply tension / traction to a portion of the target tissue engaged with the first medical device 146 while allowing the portion of the target tissue engaged with the second medical device 147 to remain relaxed. Additionally or alternatively, the first and second medical devices 146, 147 can include colors that match or otherwise correspond to the respective colors of the first and second filaments 230, 231 to which they are attached, to further facilitate the ability of medical professionals to apply and release tension / traction as needed.

[0039] Although the second filament 231 is described as being attached to the second medical device 147 by first removing the endoscope system 300 from the patient's body, in various embodiments, the distal end of the second filament 231 can be attached to the arms 147a, 147b of the second medical device 147 within the body cavity, for example, by preloading the second filament 231 along the outer surface of the slender tubular member 210 and the cap 220 and through the channel of the second guide 227, then passing the arms of the second medical device through the loop 233 (e.g., a sliding knot) of the second filament 231 within the body cavity and then retracting the second filament 231 proximally to tighten the loop 233.

[0040] refer to Figure 6In one embodiment, the endoscope system 400 of the present invention can include the same or similar elements as the endoscope systems 200, 300, and further includes a flexible elongated shaft 234 that can extend along the outer surfaces of the elongated tubular member 210 and the cap 220 and through the channel of the first guide 226. In various embodiments, the flexible elongated shaft 234 can be slidably and / or rotatably disposed within the first guide 226 such that the distal end 238 of the flexible elongated shaft 234 can extend distally beyond the distal end of the cap 220. The first filament 230 can extend through the entire length of the flexible elongated shaft 234 such that the distal end of the first filament 230 can be attached to the arm of the first medical device 146 and the proximal end 236 of the first filament 230 can extend outside the patient's body, as discussed above. In various embodiments, the flexible elongated shaft 234 can include sufficient stiffness (e.g., columnar strength) such that a medical professional can advance the flexible elongated shaft 234 distally through the channel of the first guide 226 to apply tension / traction to the first medical device 146 engaged with the target tissue 148 in a direction opposite to the distal end of the cap 220 (e.g., distally away from the distal side of the cap 220).

[0041] Although the endoscope system 400 is described as including a single flexible elongated shaft 234 extendable along the outer surface of an endoscope including a cap 220 with a first guide 226 attached thereto / mounted thereto, in various embodiments, the endoscope system of the present invention may include a cap with more than one guide attached thereto / mounted thereto (e.g., the first and second guides 226, 227 of the system 300), each of which may slidably and / or rotatably receive a separate flexible elongated shaft therethrough. In various further embodiments, the endoscope system of the present invention, which may include multiple guides attached to / mounted on the outer surface of the cap 220 (e.g., the first and second guides 226, 227 of the system 300), may include a flexible elongated shaft extending through one of the guides and a filament without a flexible elongated shaft extending through another guide, for example, to allow a physician to apply tension / traction in both proximal and distal directions relative to the distal end of the cap. In various additional embodiments, the flexible, elongated shaft 234 of the present invention can be advanced over the first or second filament 230, 231 of the present invention and through the corresponding channels of the first or second guide members 226, 227 while a medical device attached to the distal end of the filament engages the target tissue, for example, to allow a physician to switch the direction of tension / traction applied to the target tissue.

[0042] refer to Figure 7In one embodiment, the proximal end of the flexible elongated shaft 234 of the present invention can be attached to a handle assembly 138. In various embodiments, the handle assembly 138 can include a first clamping element 138a (e.g., a thumb ring), a second clamping element 138b (e.g., a first finger ring), and a third clamping element 138c (e.g., a second finger ring). The first clamping element 138a can be attached to the proximal end of the flexible elongated shaft 234 and the second and third clamping elements 138b, 138c can be pivotally and / or slidably attached to the handle assembly 138 by a connecting arm 139. The proximal end of the filament of the present invention (e.g., the first or second filament 230, 231) can be directly or indirectly attached (e.g., tied, glued, etc.) to the connecting arm 139 between the second and third clamping elements 138b, 138c. In one embodiment, a medical professional can hold the handle assembly 138 in their hand and use the first gripping element 138a to proximally retract and / or distally advance the flexible elongated shaft 234 through a channel of a guide (e.g., first or second guides 226, 227) of the present invention, for example, to apply or release tension / traction on the filament in a distal direction relative to the distal end of the cap 220. Additionally or alternatively, the medical professional can retract and / or distally extend the filament through the guide by longitudinally pivoting and / or sliding the second and third gripping elements 138b, 138c relative to the handle assembly 138 (e.g., in a front-to-back direction). In various embodiments, the first gripping element 138a can provide coarse / gross control of the flexible elongated shaft 234, for example, to position or reposition the distal end 238 of the flexible elongated shaft relative to the target tissue, and the second and third gripping elements 138b, 138c can provide fine / incremental control of the filament to precisely manipulate the target tissue.

[0043] refer to Figure 8 In one embodiment, the handle assembly 138 of the present invention may include Figure 8The present invention also provides a handle assembly that is identical or similar to the handle assembly of the present invention, but has independently actuatable second and third clamping elements 138b, 138c (e.g., not attached by a connecting arm, etc.). In one embodiment, the second clamping element 138b can be pivotally and / or slidably attached to the proximal end of the filament of the present invention (e.g., the first or second filament 230, 231), and the third clamping element 138c can be pivotally and / or slidably attached to the proximal end of the flexible elongated shaft 234. In various embodiments, the first clamping element 138a can provide coarse / gross control of the flexible elongated shaft 234 (as discussed above), and the second and third clamping elements 138b, 138c can provide fine / incremental control of the filament and the flexible elongated shaft independently of each other. For example, the second clamping element 138b can be actuated to move the filament relative to the flexible slender shaft (e.g., in the anterior-posterior direction) and / or the third clamping element 138c can be actuated to move the flexible slender shaft relative to the filament (e.g., in the anterior-posterior direction along the longitudinal axis).

[0044] Although the first and second guides 226, 227 of the present invention are depicted as being positioned adjacent the proximal end of the cap 220, in various embodiments, the first and second guides 226, 227 may be attached to / mounted on the outer surface of the cap 220 at various locations (e.g., the midpoint of the cap, the proximal end of the cap, etc.). Additionally or alternatively, the first and second guides 226, 227 may extend the full length of the cap 220 and / or extend distally beyond the distal end of the cap 220.

[0045] Additionally, although the first and second guides of the present invention are described as being associated with (e.g., attached to, mounted on) the outer surface of the cap 220, and the above-described embodiments are described with reference to a cap element, it should be understood that the principles of the above-described invention apply to each embodiment even if a cap element is not provided. In this regard, reference to a cap on a structure should be understood to include reference to an element that is part of the distal end of the structure (whole or separate). For example, in various embodiments, the guides can be along the outer surface of the flexible elongated tubular member or attached to / mounted on it with or without a cap 220 attached thereto. As described above, the guides can be distributed along the outer surface of the flexible elongated tubular member in a variety of different patterns, orientations, and / or quantities, such as those described with reference to the cap. For example, a series of guides can be provided along the outer surface of the flexible elongated tubular member at intervals spaced evenly or unevenly along the longitudinal or non-longitudinal axis of the flexible elongated tubular member. In some embodiments, the guide can extend along the entire outer surface of the flexible elongated tubular member and / or the cap, for example, to provide a continuous closed channel through which the filament can extend. In some embodiments, the guide can include one or more strips or bands arranged around the respective circumferential portions of the outer surface of the flexible elongated tubular member and / or the cap. Additionally or alternatively, the flexible elongated shaft can extend along the outer surface of the elongated tubular member, regardless of whether the cap is present. In some embodiments, the flexible elongated shaft can extend through the guide, which extends along the outer surface of the elongated tubular member or is mounted thereon. The filament can extend through any of the above-described embodiments, such as through the guide and / or flexible elongated shaft of any of the above-described embodiments.

[0046] In various embodiments, the second medical device of the present invention is not limited to tissue cutting elements (e.g., electrocautery, etc.), but may include various medical instruments that are configured to manipulate the target tissue (e.g., ablation elements, needles or syringes configured to inject an agent into the target tissue, etc.).

[0047] In various additional embodiments, the first and second medical devices 146, 147 of the present invention herein may include various hemostatic and non-hemostatic tissue clips configured to secure / engage the first and second filaments 230, 231 to the target tissue. For example, the tissue clips contemplated for use with the disclosed endoscopic systems 200, 300, 400 may include a naturally open / biased configuration that is configured to move to a closed / clamped configuration when actuated by the handle assembly. Additionally or alternatively, the tissue clips contemplated for use with the disclosed tissue retraction / traction devices may include a naturally closed / biased configuration that is configured to move to an open configuration when actuated by the handle assembly. Additionally or alternatively, fasteners other than the described tissue clips may be used to secure / engage the first and second attachment members of the disclosed tissue retraction / traction devices to the wall of the body cavity. Examples of fasteners may include, but are not limited to, those disclosed in U.S. patent application Ser. No. ______ (Agent Docket No. 8150.0601), filed on the same date as this application and entitled “Tissue Retraction Band and Method of Use Thereof”; U.S. patent application publication No. 2020 / 0129181, filed on October 30, 2019, and entitled “Clamping Devices, Systems, and Methods for Engaging Tissue”; U.S. patent application Ser. No. ______ (Agent Docket No. 8150.0596), filed on the same date as this application and entitled “Tissue Clamping Devices, Systems, and Retraction Methods”; U.S. patent application publication No. 2018 / 0263614, filed on March 19, 2018, and entitled “Tissue Retraction Device and Delivery System”; and U.S. Patent No. 8,062,311, issued on November 22, 2011, and entitled “Endoscopic Hemostatic Clamping Device,” all of which are incorporated herein by reference in their entirety for all purposes. These patents and patent applications, as well as other features and methods of U.S. patent application Ser. No. __________ (Attorney Docket No. 8150.0603), filed on the same date as the present application and entitled “TISSUE RETRACTOR STRAP AND METHOD FOR TISSUE RETRACTION,” which application is incorporated herein by reference in its entirety for all purposes, may supplement and be used with the devices and methods of the present invention.

[0048] Additionally, it should be understood that the first and second medical devices 146, 147 of the present invention are not necessarily drawn to scale, but may be shown in somewhat exaggerated form to provide a level of detail necessary to understand and practice embodiments of the present invention.

[0049] All of the apparatus and / or methods disclosed and claimed herein can be made and executed without undue experimentation in accordance with the present invention. Although the apparatus and methods of the present invention have been described in terms of preferred embodiments, it will be apparent to those skilled in the art that variations can be made to the apparatus and / or methods and to the steps or sequences of steps of the methods described herein without departing from the concept, spirit, and scope of the present invention. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope, and concept of the present invention as defined by the appended claims.

Claims

1. A system for use with an endoscope, comprising: a cap attachable to the distal end of the endoscope, the cap having a working channel extending therethrough, the cap including a lumen coextensive with the working channel; a first guide attached to an outer surface of the cap; a first filament extendable through the first guide and along an outer surface of the endoscope and the cap; as well as a first endoscopic instrument positionable within the working channel and comprising a tissue clamp at a distal end thereof; Wherein the distal end of the first filament is attached to the tissue clamp. 2 . The system of claim 1 , wherein the first endoscopic instrument comprises a sheath, and the tissue clamp is releasably attached to a distal end of the sheath.

3. The system of claim 2, wherein the distal end of the first filament is attached to an arm of the tissue clamp.

4. The system of claim 3, further comprising a handle operably coupled to the proximal end of the first endoscopic instrument, wherein the handle is configured to move the tissue clamp between the first and second positions, and wherein the handle is configured to release the tissue clamp from the distal end of the sheath.

5. The system of claim 1, further comprising a flexible, elongated shaft extendable along the outer surfaces of the endoscope and the cap and through the first guide, wherein the first filament extends through the flexible, elongated shaft.

6. The system of claim 5, further comprising a handle assembly attached to the proximal end of the flexible elongated shaft, wherein the handle assembly comprises first, second, and third clamping elements.

7. The system of claim 6, wherein the first clamping element is configured to advance and retract the flexible elongated shaft through the first guide.

8. The system of any one of claims 6 to 7, wherein the second and third clamping elements are attached to each other by a connector, and wherein the proximal end of the first filament is attached to the connector.

9. The system of any one of claims 6 to 7, wherein the second and third clamping elements are actuatable independently of one another, wherein the second clamping element is attached to the distal end of the first filament and the third clamping element is attached to the distal end of the flexible elongated shaft.

10. A system for performing endoscopic surgery, the system comprising: a first guide extendable along at least a portion of an exterior surface of an endoscope having a working channel extending therethrough; a first filament extendable through the first guide and along an outer surface of the endoscope; as well as a first endoscopic instrument positionable within the working channel and comprising a tissue clamp at a distal end thereof; Wherein the distal end of the first filament is attached to the tissue clamp.

11. The system of claim 10, wherein the first endoscopic instrument comprises a sheath, and the tissue clamp is releasably attached to a distal end of the sheath.

12. The system of claim 11, wherein a distal end of the first filament is attached to an arm of the tissue clamp.

13. The system of claim 10, further comprising a second guide extending along a portion of the outer surface of the endoscope and a second filament extending through the second guide and along the outer surface of the endoscope, wherein a distal end of the second filament is attached to an arm of a second medical device.

14. The system of claim 10, further comprising a flexible elongated shaft extendable along an outer surface of the endoscope and through the first guide, wherein the first filament extends through the flexible elongated shaft.

15. The system of any one of claims 13 to 14, further comprising a flexible elongated shaft extendable along an outer surface of the endoscope and through the second guide, wherein the second filament extends through the flexible elongated shaft.

Images