Tissue traction belt and tissue traction method

Abstract

The present disclosure relates generally to the field of medical devices. In particular, the present disclosure relates to a tissue traction device, for example for endoscopic surgery, such as endoscopic tissue anatomy. For example, a tissue traction device may include a traction strap having a first end, a second end, and a length therebetween and extending along a longitudinal axis. The first attachment member may extend from the first end of the traction strap. A second attachment member may be associated with the body between the first end and the second end of the traction strap. A third attachment member may extend from the second end of the traction strap.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority under 35 U.S.C. §119 to U.S. Provisional Patent Application No. 62 / 908,972, filed on October 1, 2019; and U.S. Provisional Patent Application No. 62 / 848,815, filed on May 16, 2019, both of which are incorporated herein by reference for all purposes. Technical Field

[0002] The present disclosure relates generally to the field of medical devices. In particular, the present disclosure relates to tissue retrieval / traction devices, such as for use in endoscopic surgery (eg, tissue dissection), and related methods of use thereof. Background Art

[0003] An integral component to accurately and efficiently performing endoscopic tissue removal / dissection procedures is the ability to maintain traction while dissecting the boundaries of the target tissue. The traction system may be unable to maintain or adjust the tension applied to the target tissue, which may impede the medical professional's visualization of the target tissue and / or interfere with auxiliary tools. These side effects may directly lead to increased surgical time, complexity, and risk of perforation or bleeding.

[0004] It is with these considerations in mind that improvements to the disclosed tissue retrieval devices and related methods of use may be useful. Summary of the invention

[0005] The present disclosure relates generally to medical devices in its various aspects, and more specifically to tissue retrieval / traction devices, retrieval / traction methods, and related delivery systems. According to embodiments of the present disclosure (including as described herein), side effects centered on endoscopic surgery (such as tissue resection / dissection surgery), such as visualization, surgical time, and surgical complexity, can be reduced. In one aspect, the tissue retrieval / traction device may include a traction belt having a first end, a second end, and a length extending along a longitudinal axis between the two ends. The traction belt may include a compliant or semi-compliant material. The body may be disposed at the first end of the traction belt. At least one protrusion may be disposed on the body. The ring may be disposed around the traction belt and positioned along the length of the traction belt. The first attachment member may extend from the first end of the traction belt. The second attachment member may be associated with the body between the first end and the second end of the traction belt. The third attachment member may extend from the second end of the traction belt. The ring may slide along the length of the traction belt. The second attachment member may extend from the ring.

[0006] In the embodiments described herein, the loop may be disposed around the traction belt and positioned along the length of the traction belt. The body may be disposed at a first end of the traction belt. At least one protrusion may be disposed on the body. The loop may be fixed to the traction belt. The protrusion may extend radially away from the longitudinal axis of the traction belt at a certain angle. A plurality of protrusions may be disposed circumferentially around the body. The first attachment member, the second attachment member, and the third attachment member may each be selected from a loop, a hook, an anchor, a barb, an eyelet, or a clamp, or a combination thereof. A first stopper may be disposed around the traction belt between the loop and the first end. The first stopper may be configured to prevent the loop from translating to the first attachment member along the length of the traction belt. The second stopper may be disposed around the traction belt between the loop and the second end. The second stopper may be configured to prevent the loop from translating to the second attachment member along the length of the traction belt. The device may include at least a first and a second protrusion. The second protrusion may be disposed on the body between the first protrusion and the first end of the body. At least one of the first attachment member, the second attachment member, and the third attachment member may include a visual indicator that can be visually distinguished from the remaining members.

[0007] In one aspect, a tissue retrieval / traction system may include a tissue retrieval / traction device. The tissue retrieval / traction device may include a traction belt having a first end, a second end, and a length between the two ends. The device may include a body coupled to the traction belt. At least one protrusion may be disposed on the body. A first attachment member may extend from the body. A second attachment member may extend from the traction belt. The second attachment member may slide along the traction belt. A third attachment member may extend from the second end of the traction belt. A first tissue fastener may engage with the first attachment member. A second tissue fastener may engage with the second attachment member. A delivery catheter may be configured to deliver the traction belt, the first tissue fastener, and the second tissue fastener.

[0008] In various embodiments, the grasping tool may be configured to engage with the third attachment member and move the third attachment member to engage with the protrusion. The first tissue fastener may be configured to reversibly engage the first attachment member with the first target tissue location. The second tissue fastener may be configured to reversibly engage with the second target tissue location engaged to the second attachment member. The third tissue fastener may engage with the third attachment member. The body may be disposed at the first end of the traction band. The tissue retrieval / traction device and the first tissue fastener may be pre-loaded in the delivery catheter prior to use. The first tissue fastener may engage with the first attachment member. The ring may be disposed around the traction band and positioned along the length of the traction band. The second attachment member may extend from the ring.

[0009] In various embodiments, the attachment member may be associated with an outer sleeve or outer sleeve segment located above the traction band between its first end and second end. One or more attachment members may be coupled to at least one of the outer sleeve segments. In various embodiments, the attachment member may be connected to more than one segment or each segment of the segmented outer sleeve.

[0010] In one aspect, a method of retrieving tissue may include delivering a tissue traction device to a target tissue. A first attachment member from a first end of the tissue traction device may be attached to the target tissue. A second attachment member from a length of the tissue retrieval / traction device may be attached to an anchoring portion of the tissue. The surgery may then be performed on the target tissue. In some embodiments, the target tissue may be excised. A third attachment member extending from a second end of the tissue retrieval / traction device may be coupled to a first protrusion extending from the tissue retrieval / traction device. The tension applied to the target tissue by the tissue retrieval / traction device and / or the length of the tissue retrieval / traction device may be adjusted.

[0011] In various embodiments, the third attachment member can be engaged from the second end of the tissue retrieval / traction device to a first protrusion extending from the tissue retrieval / traction device or to another tissue anchor. The third attachment member can be moved from the first protrusion to the second protrusion extending from the tissue retrieval / traction device. The first attachment member and the target tissue can be engaged with the first fastener. The second attachment member and the anchor of the tissue can be engaged with the second fastener. The access area below the target tissue can be visualized, and the position of the third attachment member can be adjusted based on the visualized access area.

[0012] In various embodiments, a first attachment member from a first end of a tissue retrieval / traction device may be attached to a target tissue. A second attachment member from a second end of a tissue retrieval / traction device may be attached to a first tissue anchoring portion. A procedure may then be performed on the target tissue. In some embodiments, the target tissue may be excised. A third attachment member extending from the tissue retrieval / traction device between the first and second ends of the tissue retrieval / traction device may be coupled to a second tissue anchoring portion spaced apart from the first tissue anchoring portion. The tension applied to the target tissue by the tissue retrieval / traction device and / or the length of the tissue retrieval / traction device may be adjusted. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Non-limiting embodiments of the present disclosure are described below by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. For example, the device may be enlarged so that details are discernible, but is intended to be scaled down relative to, for example, fitting within a delivery catheter or working channel of an endoscope. In the accompanying drawings, each identical or nearly identical illustrated component is typically represented by a number. For clarity, not every component is labeled in each of the drawings, nor is every component of each embodiment shown, and a person of ordinary skill in the art can understand the present disclosure without the need for explanation. In the drawings:

[0014] Figure 1 A tissue traction device according to one embodiment of the present disclosure is shown;

[0015] Figure 2A The invention shows a method for transporting a device inside an endoscope according to an embodiment of the present invention. Figure 1 Tissue traction device;

[0016] Figure 2B A method of engaging a fastener with a target tissue according to one embodiment of the present disclosure is shown. Figure 1 and Figure 2A Tissue traction device;

[0017] Figure 2C Shows Figures 1 to 2B A tissue retraction device, wherein another fastener according to one embodiment of the present disclosure is engaged with the tissue anchoring portion;

[0018] Figure 2D Shows Figures 1 to 2C A tissue pulling device, wherein the attachment member is moved toward the protrusion of the tissue pulling device by a grasping element according to one embodiment of the present disclosure;

[0019] Figure 2E Shows Figures 1 to 2D a tissue pulling device, wherein the attachment member engages with a protrusion of the tissue pulling device;

[0020] Figure 3A A diagram showing a fastener fixed to a target tissue and an anchor tissue according to an embodiment of the present disclosure Figure 1 The tissue traction device and the tissue being removed;

[0021] Figure 3B An embodiment according to the present disclosure is shown Figure 1 and Figure 3A A tissue pulling device, wherein the attachment member is moved toward the protrusion of the tissue pulling device by a grasping element;

[0022] Figure 3C Shows Figure 1 , 3A and a tissue traction device of 3B, wherein Figure 3B The attachment member engages with the protrusion of the tissue pulling device;

[0023] Figure 3D An embodiment according to the present disclosure is shown. Figure 1 and Figures 3A-3C The tissue retraction device of claim 1, wherein the attachment member is engaged by a fastener with a second tissue anchor;

[0024] Figure 4 Another embodiment of a tissue retraction device according to the present disclosure and a first embodiment of an attachment member are shown;

[0025] Figure 5 According to the present disclosure, a similar Figure 4 An embodiment of a tissue pulling device of a tissue pulling device of the invention, but showing a second embodiment of the attachment member;

[0026] Figure 6 According to the present disclosure, a similar Figure 4 and Figure 5 An embodiment of a tissue pulling device of a tissue pulling device of , but showing a third embodiment of the attachment member;

[0027] Figure 7 According to the present disclosure, a similar Figure 4-Figure 6 An embodiment of a tissue pulling device of a tissue pulling device, but showing a fourth embodiment of the attachment member;

[0028] Figure 8 Shows Figure 6 A portion of a tissue retraction device, wherein the attachment member is in a substantially straight state;

[0029] Fig.9A One example of a tissue clip that may be used with embodiments of the present disclosure is shown in a closed configuration;

[0030] Fig. 9B Shown in an open configuration Fig.9A Tissue folder.

[0031] It should be noted that these figures are intended to depict only typical or exemplary embodiments of the present disclosure. Therefore, these figures should not be considered to limit the scope of the present disclosure. The present disclosure will now be described in more detail with reference to the accompanying drawings. DETAILED DESCRIPTION

[0032] As used herein, "proximal" refers to the end of the device along the device that is closest to the medical professional when the device is introduced into a patient, and "distal" refers to the end of the device or object along the device that is farthest from the medical professional during implantation, positioning, or delivery.

[0033] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the word "or" is generally used in its sense including "and / or" unless the context clearly dictates otherwise.

[0034] It should be noted that references to "one embodiment," "some embodiments," "other embodiments," etc., in this specification indicate that the described embodiment may include one or more specific features, structures, and / or characteristics. However, such a statement does not necessarily mean that all embodiments include the particular feature, structure, and / or characteristic. In addition, when a specific feature, structure, and / or characteristic is described in conjunction with one embodiment, it should be understood that such feature, structure, and / or characteristic may also be used in conjunction with other embodiments, whether or not explicitly described, unless otherwise clearly stated.

[0035] All numerical values ​​herein are assumed to be modified by the word "about", whether or not explicitly indicated. In the context of numerical values, the word "about" generally refers to a series of numbers that those skilled in the art will consider to be equivalent to the listed values ​​(that is, having the same function or result). In many cases, the term "about" may include a numerical value rounded to the nearest significant figure. Other uses of the word "about" (that is, in a context different from a numerical value) may be assumed to have their common and usual definitions, such as from the context of this specification and understood consistently therewith, unless otherwise stated. Statements of numerical ranges using endpoints include all numbers within the range, including endpoints (e.g., 1 to 5 include 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0036] The detailed description, which should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, depicts illustrative embodiments and is not intended to limit the scope of the invention.

[0037] Several medical procedures (including those along the digestive tract and / or biliary tract) apply medical instruments to approach tissue that is intended to be removed (e.g., "target tissue") within the body. For example, in some current medical procedures (e.g., endoscopic submucosal dissection (ESD), peroral endoscopic myotomy (POEM), cholecystectomy, video-assisted thoracic surgery (VATS)), a physician may apply an endoscope or similar medical instrument to approach and remove lesions. In addition, as part of such a procedure, a physician may apply an endoscope that is capable of approaching a target tissue site while also allowing a resection device to be deployed therethrough to resect the target tissue. In addition, in some cases, an endoscope may include features that help the physician visualize and perform tissue dissection / resection procedures. For example, some endoscopes may include lights and / or cameras that are designed to illuminate and / or visualize a body cavity while navigating the endoscope and positioning it adjacent to a target tissue site. In addition, some endoscopes may also include an inner cavity (e.g., a working channel) through which a resection device, a grasping member, a delivery catheter for a resection device and a grasping member, or other accessory devices may be deployed and applied. Alternatively or additionally, other visualization methods may be applied, such as fluoroscopy.

[0038] Although doctors become more and more skilled in removing lesions from the inside of the body (e.g., inside the digestive tract, abdominal cavity, chest cavity, etc.), current retrieval methods may still be inefficient and frustrating for doctors. For example, in some cases, poor visualization and poor ability to engage and manipulate tissues may lead to lengthy tissue dissection operations. One aspect of endoscopic submucosal dissection (ESD) that may be difficult is the positioning and manipulation (e.g., retraction) of the excised tissue flap during and after the excision. In some endoscopic submucosal dissection operations (ESD), doctors can use a separate device to provide a means of tissue traction. This operation may include multiple device replacements and extended operating times. This system may not be able to maintain or adjust the tension applied to the target tissue, and / or may maintain or adjust the tension applied to the target tissue in an inefficient or inconsistent manner.

[0039] Reference Figure 1 , shows a tissue retrieval / traction (these terms are used as an alternative, or for simplicity, simply referred to as "traction", and are not intended to limit these techniques) device 105 according to one embodiment of the present disclosure, which can be inserted through a catheter or endoscope for deployment to apply tension to the target tissue. The traction device 105 includes a traction band 100, which has a first end 100d, a second end 100p, and a length extending along the longitudinal axis l between the two ends. The body 110 can be disposed at the first end 100d of the traction band 100. In several embodiments, the body 110 can be fixedly coupled to the traction band 100. In some embodiments, the body 110 can be formed integrally with the traction band 100. In other embodiments, the body 110 can be detachably coupled to the traction band 100. In some embodiments, the body 110 can be flexible, semi-rigid, or rigid. In some embodiments, the body 110 can be optional and can not be included as part of the band 100.

[0040] The first attachment member 101 extends from the first end 110d of the body 110. In several embodiments, the first attachment member 101 may extend generally along the longitudinal axis 1 and outward from the first end 110d of the body 110. The second attachment member 102 extends from the ring 104 around the traction belt 100 along its length. In several embodiments, the second attachment member 102 may extend radially outward and away from the traction belt 100, for example, generally perpendicular to the longitudinal axis 1. In use, the second attachment member 102 may be positioned at an angle relative to the longitudinal axis 1. The ring 104 may be fixed to the traction belt 100 (for example, such as pressed to it or otherwise fixed, such as by an adhesive), or the ring 104 may slide along the length of the traction belt 100 and may rotate around the longitudinal axis 1, for example, to allow the traction belt 100 to be adjusted relative to the ring 104 and the second attachment member 102. The stopper member 108 may be fixedly attached to the leash 100 on either side of the loop 104 (e.g., such as pressed thereto or otherwise secured, such as by an adhesive) such that the stopper member 108 prevents translation of the loop 104 sliding along the length of the leash 100 from extending through the stopper member 108 and away from the leash 100. The stopper member 108 may connect the first end 100d of the leash 100 to the second end 110p of the body 110 (e.g., such as pressed thereto or otherwise secured, such as by an adhesive or welding). In some embodiments, the stopper member 108 and the body 110 may be integrally formed or co-formed components, as opposed to being formed separately and then joined together. In some embodiments, the device may exclude the stopper member 108 (e.g., a device having a fixed loop 104). The third attachment member 103 extends from the second end 100p of the leash 100. In several embodiments, the third attachment member 103 can extend generally along the longitudinal axis 1 and outwardly from the second end 100 p of the towing body 100 .

[0041] Attachment members 101, 102, 103 are loops / loops that can be engaged by the distal end of a medical device or by a fastener. Although loops / loops are depicted, various other devices may be used, such as hooks, anchors, knots, barbs, eyelets, clamps, combinations thereof, and the like, and reference to any such terms herein is not intended to be limiting. In various embodiments, the attachment members may include polymer strands (e.g., polypropylene, polyester, nylon, polyethylene, elastic polymers including thermoplastic elastomers (TPEs), polyisoprene, silicone, etc.), metal wires (e.g., stainless steel, titanium, cobalt-chromium alloys, nickel-titanium alloys, etc.), and / or natural fibers (e.g., cotton, wool, silk, etc.). In some embodiments, for example, in embodiments that do not include body 110, one or more or all of the first, second, and third attachment members may be directly attached to band 100, or may be integral with band 100 such that the shape of the attachment member (e.g., loop) may be incorporated into the shape of band 100. For example, referring to Figure 1 In several embodiments, the strap 100 may be constructed without the body 110 and have a loop of attachment members 101, 102, 103 as an extension of the strap 100 and / or integral with the strap 100, with the attachment members 101, 103 as part of the strap 100 being arranged parallel to the longitudinal axis 1 and the attachment member 102 being perpendicular in the illustrated arrangement, or alternatively, the attachment member 102 may be arranged parallel to the longitudinal axis 1 and along the length of the body 110, similar to the attachment members 101, 103. With respect to the foregoing embodiments and others, more than three attachment members may be arranged along the strap 100, including or excluding the body 110, and wherein one or more attachment members between the end attachment members (e.g., the attachment members 101, 103) are fixed relative to the strap 100, slidable, and / or integral with the strap 100.

[0042] A series of protrusions 106 are provided on the body 110. The protrusions 106 extend generally radially away from the longitudinal axis 1 along the length of the traction belt 100. The protrusions 106 extend radially away from the longitudinal axis 1 along the length of the belt by a number of degrees α, which reading α may be, for example, about 10°, about 15°, about 30°, about 45°, about 60°, about 90°, etc., or any angle therebetween. The protrusions 106 are arranged around the body 110 and circumferentially around the longitudinal axis 1 of the traction belt 100. The protrusions 106 are arranged in rows and columns such that the protrusions 106 are located at different lengths along the longitudinal axis 1 and at different arc lengths around the circumference of the body 110. In some embodiments, the shapes of the protrusions 106 may be designed to be different from one another. Figure 1 , and may correspond to or supplement the attachment members 101, 102, 103, for example, hooks, loops, ribs, holes, etc. for attachment. In several embodiments, the protrusions 106 may be uniformly arranged on the body 110, for example, each protrusion 106 extends at the same angle and configuration. In some embodiments, the protrusions 106 may be non-uniformly arranged on the body 110, for example, extending at different angles, lengths, configurations, directions, etc. In some embodiments, at least one protrusion 106 may extend in a first direction, and at least another protrusion 106 may extend in a second direction substantially opposite to the first direction. In some embodiments, the protrusions 106 may be shaped and arranged so that some extend perpendicular to the body 110, some extend proximally and some extend distally, wherein protrusions with different directions are arranged along the length and around the circumference of the body 110, so that the user has different choices of protrusions with which the attachment member can engage. This choice may depend on the desired tension, angle, etc.

[0043] Reference Figure 2A, shows a traction device 205 according to one embodiment of the present disclosure, the traction device 205 including a traction band 200 and a first attachment member 201 engaged by a first clamp 221. The first clamp 221 can be attached to the distal end of a delivery catheter 260 and can be preloaded with the first clamp 221 engaged with the first attachment member 201. The delivery catheter 260 and the attached traction device 205 can include an outer sheath 262, which can be a part of the delivery catheter 260. The delivery catheter 260 with or without the outer sheath 262 can be delivered through the working channel 264 of the endoscope 230 or through some other introducing sheath or catheter. Grabber tool 232 (with or without its own grasping grasper catheter or cannula 261) may be delivered independently of delivery catheter 260, through working channel 264 of endoscope 230, through another independent working channel of endoscope 230, or, if sufficiently small, through the working channel of delivery catheter 260 while delivery catheter 260 is within working channel 264 of endoscope 230. Alternatively, traction device 205, first clamp 221, and grasper tool 232 may each have their own delivery catheters, which may each be delivered through working channel 264 or multiple working channels of endoscope 230, one at a time or simultaneously, or some combination thereof. In some embodiments, first clamp 221 may be deployed in a delivery catheter that is already coupled to an attachment member of traction device 205. In such a case, clamp 221 may be fixedly or removably coupled to attachment member 201, or to band 200 itself.

[0044] Reference Figure 2B , shows a tissue retrieval system according to one embodiment of the present disclosure. The target tissue 240 is shown initially excised from surrounding tissue 242 (however, the devices and systems described herein may be used prior to the initial excision of the target tissue 240). The medical professional may perform an excision procedure by further excising the target tissue 240 away from the area 241 below the target tissue 240. However, the area 240 may be difficult to visualize and / or access with an excision tool. To help more effectively see, access, or otherwise excise the tissue, a Figure 2A The first clamp 221 and the traction device 205 are delivered to the target tissue 240. The first clamp 221 may already be engaged with the first attachment member 201 of the traction device 205, or may be manipulated to engage therewith. The first clamp 221 engaged with the first attachment member 201 may be manipulated to engage with a portion of the target tissue 240.

[0045] Reference Figure 2C, the second clamp 222 can be manipulated to engage with the second attachment member 202, which is shown extending from the sliding ring 204 of the traction device 205 (e.g., extending through the center of the ring 204 to couple to the ring 204). Alternatively, the second clamp 222 can be delivered to engage with the second attachment member 202 and pre-loaded into the working channel of the delivery device rather than being introduced after the first clamp 221 is engaged with the target tissue 240. The second clamp 222 can be further manipulated to engage with the anchoring tissue 244 of the tissue while being engaged with the second attachment member 202 ("anchoring tissue"). Alternatively, the second attachment member 202 can be directly attached to the belt 200, or can be integral with the belt 200, rather than extending from the sliding ring 204. In this case, the second clamp 222 can be engaged with the second attachment member 202, and can be engaged with the anchoring tissue 244 in a similar manner. The anchoring tissue 244 may be a tissue at a distance from the target tissue 240 (e.g., on an opposing tissue wall, at a distance distal to or proximal to the target tissue 240), or other separate tissue. Figure 2D 240 . If the body 210 in the figure is present as part of the band 200, it can be positioned so that at least one of the protrusions 206 extends toward the target tissue 240. Since the first attachment member 201 is fixed to the target tissue 240 by the first clamp 221 and the second attachment member 202 is fixed to the anchoring tissue 244, the device 205 can be maintained in tension. The tensioning device can cause the sliding ring 204 to translate along the length of the traction band 200 toward the anchoring tissue 244. The tensioning device 205 tensions the target tissue 240 in a direction toward the anchoring tissue 244 or otherwise positions the target tissue 240 as desired, for example, exposing an area 241 below the target tissue 240, which can allow the excision tool to further excise the target tissue 240. The traction band 200 can stretch when the device 205 is in a tensioned state, thereby allowing the length between the target tissue 240 and the anchoring tissue 244 to change. The stopper member 208 ( Figure 2B ) prevents the loop 204 from translating along the traction belt 200, passing over the third attachment member 203, and leaving the device 205.

[0046] Reference Figure 2D, the grabber 232 can extend through the working channel of the endoscope 230 and be oriented toward the device 205. The grabber 232 can be manipulated to engage with the third attachment member 203 extending from the second end 200p of the traction band 200. The grabber 232 engaged with the third attachment member 203 can be manipulated at the first end 200d of the traction band 200 in a direction 236 toward the body 210 (e.g., in the general direction of arrow 236). As the grabber 232 manipulates the third attachment member 203 and the second end 200p toward the protrusion 206 of the body 210, the traction band 200 can be stretched and / or extended through the loop 204, which is generally fixed to the anchor tissue 244 by the second attachment member 202 and the second clamp 222, thereby acting as a pivot point. For example, the loop 204 can act as a simple machine pulley, wherein the traction band 200 translates through the loop 204. As the traction band 200 is extended through the loop 204 and / or as the traction band 200 is folded so that the second end 200p is manipulated toward the first end 200d of the traction band 200, the length of the device 205 from the target tissue 240 to the anchoring tissue 244 is shortened. The shortened length of the device 205 can result in an increase in tension or traction on the target tissue, which lifts the target tissue 240 further away from the surrounding tissue 242 and exposes or more clearly exposes a larger additional and / or different area 241 for entry of a resection tool to further resect the target tissue 240, as compared to the beginning of the resection procedure.

[0047] Reference Figure 2E , the third attachment member 203 engages with one of the protrusions 206, for example, by forming a loop over the selected protrusion 206. As previously described, at least one of the protrusions 206 extends radially outward at an angle and is positioned to extend toward the target tissue 240 to allow the third attachment member 203 to grasp and hold the selected protrusion 206. This configuration temporarily locks the traction band 200 in the extended and / or folded configuration via the loop 204, thereby maintaining the shortened length of the device 205 (compared to the longer length of the device 205, for example, in Figure 2C This shortened length of the device 205 maintains the distance between the target tissue 240 and the anchoring tissue 244 and maintains the exposed area 241 for the resection tool 234 to enter to further resect the target tissue 240. The third attachment member 203 can be further manipulated (e.g., by Figure 2DThe third attachment member 203 may be manipulated (e.g., by a grasper 232) to adjust the length of the traction band 200 and the length of the device 205. For example, the third attachment member 203 may be manipulated (e.g., by a grasper or other tool) to disengage from one protrusion 206 to engage with another protrusion 206. As another example, the third attachment member 203 may be manipulated to disengage from the protrusion 206 and be released so that the third attachment member 203 is not engaged by anything, thereby releasing the tension in the traction band 200 and allowing the traction band 200 to unfold, unwind, and / or translate through the loop 204, so that the length of the device 205 between the target tissue 240 and the anchoring tissue 244 increases and the tension applied to the target tissue 240 by the device 205 decreases.

[0048] Reference Figure 3A , shows a tissue retrieval system according to one embodiment of the present disclosure. Device 305 is secured to target tissue 340, which is shown initially being resected away from surrounding tissue 342, and device 305 is secured to anchoring tissue 344. It should also be understood that target tissue 340 may not be resected when device 306 is attached, for example, prior to a dissection procedure. First attachment member 301 is engaged by first clamp 321, which is also engaged with target tissue 340. Third attachment member 303 is engaged by second clamp 322, which is also engaged with anchoring tissue 344. By further resecting target tissue 340 in area 341 below target tissue 340, a medical professional can perform a resection procedure.

[0049] Reference Figure 3B, the device 305 can be shortened in length between the target tissue 340 and the anchor tissue 344 to further expose the area 341 below the target tissue 340. The second attachment member 302 extends from the loop 304 that is fixed to the traction band 300. Although the second attachment member 302 is shown attached to the fixed loop 304 (e.g., extending through the center of the loop 304 to couple to the loop 304), wherein the fixed loop 304 is approximately in the middle of the length of the traction band 300, in various embodiments, the loop 304 can be fixed to any point along the traction band 300. Alternatively, the second attachment member 302 can extend from the second end 300p of the traction band 300 instead of the loop 304. The grabber 332 and the second attachment member 302 can be manipulated toward the body 310 at the first end 300d of the traction band 300 (e.g., in the general direction of arrow 336). As the grabber 332 manipulates the second attachment member 302 and the loop 304 toward the protrusion 306 of the body 310, the traction band 300 may be folded along the length 300f of the traction band 300 between the loop 304 and the body 310. As the traction band 300 is folded, the second end 300p is moved closer to the first end 300d of the traction band 300, and the length of the device 305 from the target tissue 340 to the anchoring tissue 344 is shortened. The shortened length of the device 305 may result in an increase in the pulling force acting on the target tissue, which lifts the target tissue 340 further away from the surrounding tissue 342 and exposes or more clearly exposes a larger additional and / or different area 341 for entry of a resection tool to further resect the target tissue 340, as compared to the beginning of the resection procedure.

[0050] Reference Figure 3C , the second attachment member 302 engages one of the protrusions 306 of the body 310. This configuration temporarily locks the traction strap 300 in the folded configuration (i.e., wherein the length 300f of the traction strap 300 is folded), thereby maintaining the shortened length of the device 305 (compared to the longer length of the device 305, e.g., Figure 3A This shortened length of the now locked device 305 maintains the distance between the target tissue 340 and the anchoring tissue 344, so that the exposed area 341 can be accessed by the resection tool 334 carried by the endoscope 330 for further resection of the target tissue 340. The second attachment member 302 can be further manipulated (e.g., by Figure 3BThe second attachment member 302 can be manipulated to disengage from one protrusion 306 and engage with another protrusion 306. As another example, the second attachment member 302 can be manipulated to disengage from the protrusion 306 and release so that the second attachment member 302 is not engaged by anything, thereby releasing the tension in the traction band 300 and allowing the traction band 300 to lengthen, so that the length of the device 305 between the target tissue 340 and the anchoring tissue 344 increases.

[0051] Reference Figure 3D Alternatively, instead of the second attachment member 302 being engaged with the protrusion 306, the second attachment member 302 may be engaged with the third clamp 323. The third clamp 323 engaged with the second attachment member 302 may also be engaged with a second anchoring portion of the tissue 346 ("second anchoring tissue"). The third clamp 323 secures the second attachment member 302 to the second anchoring tissue 346, thereby causing the second attachment member 302 to move the secured loop 304 and thereby the traction band 300 toward the second anchoring tissue 346. Together, the first clamp 321 engaged with the first attachment member 301 and the target tissue 340, the second clamp 322 engaged with the third attachment member 303 and the anchoring tissue 344, and the third clamp 323 engaged with the second attachment member 302 and the second anchoring tissue 346 shorten the length of the device 305 between the target tissue 340 and the anchoring tissue 344 and the second anchoring tissue 346 (when coupled with, for example, Figure 3A 305). This shortened length of the device 305 can result in increased tension on the target tissue, which lifts the target tissue 340 further away from the surrounding tissue and exposes or more clearly exposes a larger additional and / or different area 341 for access by the resection tool 334 and the endoscope 330. The use of two anchoring tissue locations can also allow manipulation of the angle of tension that the second attachment member 302 places on the first clamp 321 and the target tissue 340. In some embodiments with more than one anchoring tissue location, the device can optionally use a sliding ring or no ring at all, in which case the attachment member 302 is directly fixed to the band 300, or is made an integral part of the band 300, as described above. In these and other cases, the body 310 may not be used.

[0052] In various embodiments, an outer sleeve may be disposed over the traction belt. The outer sleeve may be coaxial with the traction belt and may be freely movable axially and / or rotationally relative to the traction belt. The outer sleeve may have a diameter greater than the traction belt so that the outer sleeve may move relative to the traction belt when the traction belt is in an unstretched or relaxed state. Such an outer sleeve may be used to provide a rigid length to the traction device and / or to facilitate the traction belt to be moved in a delivery sleeve (e.g., Figure 2AThe outer sheath 262 shown in FIG. 1 , or any other passage or lumen through which the traction device passes, can be smoothly moved inside. Figure 4-7 , the segmented outer sleeve 470, 570, 670, 770 can be disposed above the traction belt 400, 500, 600, 700 of the device 405, 505, 605, 705. One or more attachment members 404, 504, 604, 704 can be coupled to at least one of the outer sleeve segments 474, 574, 674, 774 of the segmented outer sleeve 470, 570, 670, 770 (for simplicity, only one of the multiple segments is labeled). In some embodiments, the attachment member can be coupled to more than one segment or each segment of the segmented outer sleeve 470, 570, 670, 770.

[0053] Reference Figure 4 , the outer sleeve section 474 shown is the middle section of the outer sleeve 470, and Figure 5 In the illustrated embodiment, outer sleeve segment 574 is an end segment of outer sleeve 570. Other configurations are within the scope of the present disclosure, such as Figure 7 As an alternative to coupling the attachment member to the outer sleeve segment, the attachment member 604 may be coupled to the ring 676, such as Figure 6 As shown in. Ring 676 can be rotatably connected or positioned above traction band 600. As shown, ring 676 is positioned between two outer sleeve segments 674. However, it should be understood that ring 676 may be provided with or without outer sleeve 670. Various arrangements of outer sleeve segments and / or rings are within the scope of the present disclosure, and the illustrated embodiments do not limit the present disclosure. It should be understood that various configurations of segmented outer sleeves are within the scope and spirit of the present disclosure and are not limited by the examples shown in the accompanying drawings, and the provision of segmented outer sleeves should be understood to allow one or more attachment members to be added between the ends of traction bands 400, 500, 600, 700, thereby allowing a variety of tissue clamping configurations and the extent of traction that can be applied by traction devices 405, 505, 605, 705. One or more outer sleeve segments may have one or more attachment members connected to them. If desired, the outer sleeve (or a segment thereof) may be secured relative to the traction device (e.g., adjacent the proximal end of the traction device), such as by compression (to the traction band or an end member coupled thereto), adhesive, or other attachment known to those skilled in the art. Such securing may help to securely position the outer sleeve or a segment thereof, such as if the target tissue is positioned above the endoscope. A body having a protrusion similar to the body 110, 210, 310 described above may be used in conjunction with any of the devices 405, 505, 605, 705, or may not be provided.

[0054] Figure 4-7The traction devices 405, 505, 605, 705 and the attachment members 404, 504, 604, 704 of any or all embodiments of the present invention may be used in a manner similar to that used in the embodiments of the present invention. Figure 3D 305 of the traction device 305. In particular, the first attachment member 401, 501, 601, 701 (shown in cross-section) at the first end of the traction device 405, 505, 605, 705 can be engaged by the clamp 421, 521, 621, 721, respectively, and the clamp 421, 521, 621, 721 is also engaged with the target tissue. This example of the clamp 421, 521, 621, 721 is shown, wherein the jaws extend through the first attachment member 401, 501, 601, 701. However, other configurations of the clamp are also within the scope of the present disclosure. The third attachment member 403, 503, 603, 703 at the second end of the traction device 405, 505, 605, 705 may be engaged by a second clamp (not shown, but it may be any suitable clamp, as described herein) that also engages the first anchoring portion of the tissue in the first position ("first anchoring tissue"). If additional traction or tension is required, or a change in the direction of traction or tension is required, then the attachment member 404, 504, 604, 704 may be engaged by a third clamp (not shown, but it may be any suitable clamp, as described herein) that also engages the second anchoring portion of the tissue in a second position ("second anchoring tissue") that may be spaced apart from the first anchoring tissue. This may be achieved as described with respect to Figure 3D Similar effects and benefits are described, and reference is made to this above description for the sake of brevity but not limitation. It should be understood that with any of these embodiments, other angles at which traction or tension may be applied during a procedure performed on a target tissue (such as resection or dissection of a target tissue) may be advantageous, thereby allowing for improved manipulation of the tissue and / or greater freedom in manipulating tissue (such as fibrotic tissue), which may be more easily moved in certain directions than in other directions.

[0055] It should be understood that the attachment members 404, 504, 604, 704 may be coupled to the outer sleeve segments 474, 574, 774 or the ring 676 in a variety of ways within the scope of the present disclosure. Figure 4 In some embodiments shown in , the attachment member 404 can be coupled to the outer sleeve segment 474 by forming a loop through the outer sleeve segment 474. Similarly, in some embodiments, such as Figure 6 As shown in FIG. 6 , the attachment member 604 may be passed through the center of the ring 676 to couple with the device 605. If desired, in addition to passing through the internal passage of the outer sleeve segment, such as Figure 7As shown in , a portion of the attachment member may pass through a hole in the wall of the outer sleeve segment 774 from inside the outer sleeve segment 774, and a thickened area 778 (such as a crimp or knot or a weld of the end of the element forming a looped attachment member, etc.) may be formed to hold the portion outside the outer sleeve segment 774, where a portion of the attachment member passes through the hole in the wall of the outer sleeve segment 774. Alternatively, in some embodiments, such as Figure 5 As shown in FIG, the attachment member 504 can be coupled to the outer sleeve segment 574 by attaching through a hole in the wall of the outer sleeve segment 574. It should be understood that the location of the hole can be changed as desired. It should also be understood that any of the above-described ways of coupling the attachment member to the outer sleeve segment can be applied to Figure 4-7 In any embodiment of the present invention, such as by Figure 7 . It should also be understood that the manner in which the attachment members 404, 504, 604, 704 are coupled to the outer sleeve segments 474, 574, 774 or the ring 676 can be applied to the above-described attachment members 101, 102, 103, 201, 202, 203, 301, 302, 303 and also to the components of the respective traction devices 105, 205, 305. Alternatively / additionally, the attachment members 101, 103, 201, 203, 301, 303 at the ends of the traction devices 105, 205, 305 can be coupled to the components at the ends of the traction devices 105, 205, 305 via overmolding / embedding; including a feature on the attachment member that provides an interference fit with the components at both ends of the traction device; or by an adhesive (e.g., bonded to the traction straps 100, 200, 300). For example, the attachment members 101 , 103 , 201 , 203 , 301 , 303 may be formed wherein a knot or crimp or other expanded region passes within the interior of the body 110 , 210 , 310 and is retained therein by a constriction (eg, a narrow passage) within the body 110 , 210 , 310 .

[0056] It may be desirable for the connector to be in a substantially straight position relative to the outer cannula segment 474, 574, 674, 774, such as during delivery within the outer sheath 262 or delivery catheter 260. Figure 8 , showing Figure 6 605, the attachment member 604 can be in a generally straight position above the outer sleeve segment 674 of the segmented tube 670 adjacent to the element to which the attachment member 604 is coupled (in this case, the ring 676). Alternatively, the attachment member 604 can be tucked inside the adjacent outer sleeve segment 674 in a generally straight position. It should be understood that if Figure 4 or Figure 5 or Figure 7As shown in the figure, the attachment members 404, 504, 704 connected to the outer casing segment 474, 574, 774 can be in a straight state relative to the outer casing segment to which the attachment members 404, 504, 704 are connected, or relative to the adjacent outer casing segment (the outer casing segment to which the adjacent attachment members 404, 504, 704 are connected).

[0057] In various embodiments, the traction band may include a compliant or semi-compliant material (eg, thermoplastic elastomer (TPE), polyethylene terephthalate (PET), elastic polymer, rubber, plastic, etc.) The traction band may be an elongated cylindrical tube and may be shaped hollow or solid.

[0058] In various embodiments, the body may include a non-compliant, semi-compliant, or compliant material (e.g., TPE, PET, elastomeric polymers, rubber, plastic, metal, metal alloy, etc.). The traction band may be overmolded onto the body and / or the stopper member. The body may be injection molded. The body may have holes for attachment members at one or both ends of the body. The body may have a greater tensile strength than the traction band so that it can withstand the attachment member engaged and pulled on the protrusion of the body. The stopper member may be pressed onto the traction band and / or the body. The body and / or the stopper member may include a suture looped or bound to the body and / or the stopper member, which may be used as a track for keeping the device in the patient's body or a tether for manipulating the device.

[0059] In various embodiments, the attachment member may include compliant or semi-compliant materials (e.g., TPE, PET, elastic polymers, rubber, plastics, etc.). The attachment member may include various shapes, such as loops, hooks, anchors, barbs, eyelets, clamps, etc. The attachment member may be metal, plastic, braided material, or any other material that can be molded in a desired shape. By melting and combining the ends of the material, the strands of polymer material can be made into an annular attachment member. The ends of the attachment member can be combined by methods such as compression bonding. The attachment member may be fixed to another element or component or can be freely rotated relative to the element or component to which it is connected. The attachment member may have a material strength configured to fail under a predetermined load as a safety feature to limit the amount of tension in the attachment member, the device, and the surrounding tissue. One or more attachment members may be visually marked so that the attachment member is visually distinguished relative to other attachment members. For example, the attachment member may vary in color, pattern, or radiopacity so that a medical professional can easily identify a specific attachment member, anchor tissue, secondary anchor tissue, protrusion, etc. for fixation to a target tissue. In various embodiments, such as embodiments with relatively flexible attachment members, the attachment member may be positioned in a generally straight position against the device 105, 205, 305, 405, 505, 605, 705 during delivery, as described above with respect to Figure 6 In some embodiments, once the device 105, 205, 305, 405, 505, 605, 705 reaches the target tissue, the attachment member can be released to extend away from the device 105, 205, 305, 405, 505, 605, 705, thereby providing convenient access to the attachment member while coupling the clamp to the attachment member inside the body. Figure 8 One way of maintaining the attachment member in a delivery configuration, such as being generally straight along the device, is shown in FIG.

[0060] In various embodiments, some steps of assembling the tissue retraction device may occur outside the patient's body, while other steps associated with assembling the tissue retraction device may occur inside the patient's body.The steps described herein do not have to occur in a particular order and / or timing.

[0061] The medical devices used with the various embodiments of the devices, systems, and methods herein are not limited to those illustrated and discussed, but may include a variety of medical devices (e.g., ablation elements, biopsy needles, injection needles, scissors, graspers, clamps, etc.).

[0062] In various embodiments, the access area under and around the target tissue to be resected by the medical professional can be visualized. The visualization can be optical, fluorescent, ultrasonic, etc. The visualization of the area under and around the target tissue may not be sufficiently revealed to allow the medical professional to manipulate the medical device to the access area to resect the target tissue. The medical professional can deliver and deploy the tissue retrieval system to the target tissue and anchor tissue at a length and / or tension that reveals the access area for performing the procedure. The medical professional can adjust the length or tension of the system based on the visualization of the target tissue or access area.

[0063] In various embodiments, the attachment member can be engaged with a variety of fasteners that are configured to engage the tissue traction device with the tissue, such as a clip, anchor, screw, needle, or the like. One of the attachment members can be obtained by or permanently connected to the deployable clamp. Once obtained by the attachment member, or if connected, the clamp will be deployed on the tissue flap created along the edge of the target tissue. One or more clamps can be used to fix the attachment member and the traction band to the target tissue.

[0064] In various embodiments, the clamp is configured in any desired manner to couple the attachment member to another element (such as a tissue traction device) or a patient's tissue. In various embodiments, it is contemplated that a clamp for use with a tissue traction device may include a biased open configuration configured to move to a closed / clamped configuration when actuated by a handle assembly. Additionally or alternatively, it is contemplated that a tissue clip for use with the disclosed tissue traction device may include a biased closed configuration configured to move to an open configuration when a distal effector is actuated (e.g., squeezed) by a proximal handle assembly. Additionally or alternatively, fasteners other than removable / releasable tissue clips may be used to fasten / engage the attachment member of the disclosed tissue traction device to the wall of a body cavity, such as a non-repositionable clamp. Examples of fasteners may include, but are not limited to, those described in U.S. patent application Ser. No. _____________ [Agent Docket No. 8150.0596], filed on the same date as the present disclosure and entitled “Tissue Clip Device, System, and Retrieval Method”; U.S. patent application publication No. 2020 / 0129181, filed on October 30, 2019; U.S. patent application publication No. 2018 / 0263614, filed on March 19, 2018; and U.S. Patent No. 8,062,311, filed on November 22, 2011 and entitled “Endoscopic Hemostatic Clamp Device,” the entire contents of all patent applications being incorporated herein by reference for all purposes. Other features and aspects of these patents and patent applications, as well as U.S. patent application No. __________ [Agent Docket No. 8150.0601], filed on the same date as the present application and entitled “TISSUE TRACTION STRAP AND METHODS OF USE THEREOF”; and U.S. patent application No. __________ [Agent Docket No. 8150.0567], filed on the same date as the present application and entitled “Tethered Traction System and Methods of Use Thereof”, the entire contents of which are incorporated herein by reference for all purposes, may supplement the devices and methods of the present disclosure and may be applicable to the present disclosure.

[0065] Reference Fig.9A and Fig. 9B , shows an exemplary tissue clip disclosed in the above-referenced U.S. Patent Application Publication No. 2020 / 0129181 and applicable to one embodiment of the present disclosure. The tissue clip shown includes first and second members 801, 802. Two clamp arms 800 extend from the first member 801 and are received in the second member 802. The clamp arms 800 can be used as shown in Fig.9A The closed configuration shown in Fig. 9B In the closed configuration, the arms 800 are positioned toward each other, and in the open configuration, the arms 800 are separated from each other. In response to the application of the compressive force 803, the first and second members 801, 802 can each be displaced relative to each other along the longitudinal axis l into the open configuration.

[0066] In various embodiments, a method of retracting tissue may include delivering a tissue traction device to a target tissue. A first attachment member extending from a first end of the tissue traction device may be attached to the target tissue. A second attachment member extending from a length of the tissue traction device may be attached to an anchor portion of the tissue. The target tissue may be excised. A third attachment member extending from a second end of the tissue traction device may be engaged to a first protrusion extending from the tissue traction device. The tension and / or length of the tissue traction device applied to the target tissue by the tissue traction device may be adjusted. The third attachment member may be moved from the first protrusion to the second protrusion extending from the tissue traction device. The first attachment member and the target tissue may be engaged with a first fastener. The second attachment member and the anchor portion of the tissue may be engaged with a second fastener. The entry area below the target tissue may be visualized, and the position of the third attachment member may be adjusted based on the visualized area of ​​entry.

[0067] According to the present disclosure, all devices and / or methods disclosed and claimed for patent protection herein can be completed and executed without undue experimentation. Although the devices and methods of the present disclosure have been described with preferred embodiments, it is obvious to those skilled in the art that the devices and / or methods described herein and the steps or step sequences of the methods can be changed without departing from the concept, spirit and scope of the present disclosure. It is obvious to those skilled in the art that all such similar substitutions and modifications are considered to be within the spirit, scope and concept of the present disclosure as defined by the attached claims.

Claims

1. A tissue traction device, comprising: a leash having a first end, a second end, and a length extending along a longitudinal axis between the first end and the second end; a first attachment member extending from the first end of the leash; a second attachment member configured to engage tissue via a tissue fastener and extending from a loop that is slidably disposed on the traction band and that is disposed around the traction band between the first end and the second end of the traction band; as well as A third attachment member extends from the second end of the leash.

2. The tissue retraction device of claim 1, further comprising a tissue fastener, the second attachment member being configured to be attached to the tissue fastener to engage tissue via the tissue fastener.

3. The tissue traction device according to claim 1, wherein: The second attachment member is configured to engage a tissue fastener such that the tissue fastener is manipulable when engaged with the second attachment member to reversibly engage the second attachment member with tissue.

4. The tissue traction device according to claim 1, further comprising a body disposed at the first end of the traction belt and at least one protrusion disposed on the body, wherein: The protrusion extends at an angle radially away from the longitudinal axis of the traction belt.

5. The tissue retraction device of claim 4, further comprising a plurality of protrusions arranged circumferentially around the body.

6. The tissue traction device according to claim 1, wherein: At least one of the first attachment member, the second attachment member, or the third attachment member is ring-shaped.

7. The tissue traction device according to claim 1, wherein: The first attachment member, the second attachment member, and the third attachment member are each selected from a loop, a hook, an anchor, a barb, an eyelet, or a clamp.

8. The tissue traction device according to claim 2, further comprising: a first stop disposed about the leash between the loop and the first end, the first stop configured to prevent translation of the loop along the length of the leash to the first attachment member; as well as A second stop is disposed about the leash between the loop and the second end, the second stop configured to prevent translation of the loop along the length of the leash to the second attachment member.

9. The tissue retraction device of claim 4, further comprising at least first and second protrusions, the second protrusion being disposed on the body between the first protrusion and the first end of the body.

10. The tissue traction device according to claim 1, wherein: At least one of the first attachment member, the second attachment member, and the third attachment member further includes a visual indicator visually distinguishable from the remaining members.

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