Tissue retraction device and delivery system therefor - Patent application

Abstract

The tissue retraction device may have more than one gripping segment whereby it engages tissue directly or indirectly, such as by use of a tissue engaging member. The tissue retraction device may have a circumferential section defining the gripping segments, as well as an internal gripping segment defined within the periphery of the circumferential section. A traction force may be applied to the target tissue by engaging the target tissue engaging segment with the target tissue and engaging the traction tissue engaging segment with a traction tissue spaced from the target tissue. Engagement of additional target tissue engaging segments with the traction tissue (optionally at different locations) allows the force vector of the traction to be adjusted. The delivery system may include a tissue retraction device holder for maintaining a desired configuration of the tissue retraction device during its delivery to the target tissue region.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to the field of tissue retraction devices, systems, and methods, as well as tissue retraction delivery devices, systems, and methods. [Background technology]

[0002] Various surgical procedures involve lifting or separating a target tissue (a designated section of tissue) at a treatment site, such as while the target tissue remains attached to the treatment site. A tissue retraction element may be used to lift the target tissue away from the treatment site where the procedure is being performed. In some cases, the target tissue is an undesired portion of tissue that may be unhealthy, diseased (i.e., cancerous, precancerous, etc.), or otherwise healthy or unhealthy. "Target tissue" may also include tissue suspected to be unhealthy or diseased and requiring surgical removal to confirm their disease state by biopsy. Endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR) are examples of outpatient procedures for removing deep tumors from the gastrointestinal (GI) tract. Although this technique may allow the patient to recover faster and often with less pain than open or laparoscopic surgical procedures, such techniques require a high level of expertise and therefore have not yet been widely adopted. One of the biggest drivers of time and complexity is the management of the tissue being dissected / resected. As the medical professional cuts the tissue, it becomes more difficult to visualize the cut plane (the tissue being cut) as the tissue remains above the cut plane and as the medical professional must continually cut deeper into the tissue. Accurate and efficient endoscopic tissue resection / ablation procedures require the ability to maintain traction of the target tissue above the cut plane as the borders of the target tissue are ablated and the tissue being retracted is lifted. Retraction systems may not be able to maintain or adjust the tension applied to the target tissue, and in some cases may obstruct the medical professional's view of the target tissue and / or interfere with accessory instruments. These complications directly contribute to increasing the time, complexity, and risk of perforation or bleeding of the procedure. In addition, retraction devices may tend to fold or otherwise deform themselves upon delivery, making the simple delivery of such devices difficult.

[0003] Improvements to tissue retraction devices, systems and methods, as well as devices, systems and methods for delivering tissue retraction devices, would be welcomed by medical professionals. Summary of the Invention [Means for solving the problem]

[0004] This summary of the disclosure is provided to aid in understanding, as those skilled in the art will appreciate that each of the various aspects and features of the disclosure may be used advantageously separately in some cases, or in combination with other aspects and features of the disclosure in other cases. No limitations on the scope of the claimed subject matter are intended by either the inclusion or non-inclusion of elements, components, etc. in this summary.

[0005] In accordance with various principles of the present disclosure, a tissue traction device has a peripheral section defining a periphery of the tissue traction device, at least one gripping segment engageable with tissue, and at least one additional gripping segment extending within the periphery of the peripheral section and engageable with tissue. In some embodiments, the gripping segments define a target tissue engaging segment engageable with a target tissue, a first traction tissue engaging segment engageable with traction tissue spaced apart from the target tissue to apply traction to the target tissue, and a second traction tissue engaging segment engageable with the traction tissue to change a force vector of traction applied to the target tissue by the first traction tissue engaging segment.

[0006] In some embodiments, the distance between the second traction tissue engaging segment and the target tissue is less than the distance between the first traction tissue engaging segment and the target tissue. In some embodiments, the first traction tissue engaging segment and the second traction tissue engaging segment engage the traction tissue at the same location. In some embodiments, the first traction tissue engaging segment engages the traction tissue at a first location and the second traction tissue engaging segment engages the traction tissue at a second location spaced apart from the first location.

[0007] In some embodiments, a first traction tissue engaging segment engages the traction tissue at a first location and a second traction tissue engaging segment engages the traction tissue at a second location spaced apart from the first location to change the force vector of the traction applied to the target tissue.

[0008] In some embodiments, a first traction tissue-engaging segment is defined along the circumferential section and at least one additional gripping segment defines a second traction tissue-engaging segment within a periphery of the circumferential section. In some embodiments, the circumferential section has an elliptical shape, the target tissue-engaging segment is defined along a first focal point of the elliptical circumferential section, the first traction tissue-engaging segment is defined along a second focal point of the elliptical circumferential section, and the gripping segment defining the second traction tissue-engaging segment is a loop extending around the first focal point of the elliptical circumferential section.

[0009] In some embodiments, the at least one additional gripping segment includes a first loop defining a first gripping segment and a second loop defining a second gripping segment within a perimeter section.

[0010] In some embodiments, at least one of the additional gripping segments of the tissue retraction device extends transversely to the direction in which the tissue retraction device extends between the target tissue and the retracting tissue.

[0011] In some embodiments, at least one of the gripping segments defined along the periphery of the circumferential section, or at least one additional gripping segment extending within the periphery of the circumferential section, has a different thickness than another gripping segment of the tissue retraction device.

[0012] In some embodiments, the tissue retraction device is formed from an elastic material. In accordance with various principles of the present disclosure, a delivery system for a tissue retraction system includes a tissue retraction device defining a peripheral section in the form of a loop defining at least one target tissue engaging segment and at least one retracting tissue engaging segment spaced apart from the target tissue engaging segment, and a tissue retraction device holder engageable with the tissue retraction device to maintain the target tissue engaging segment spaced apart from the retracting tissue engaging segment.

[0013] In some embodiments, the tissue retraction device further includes at least one additional gripping segment defined along or extending within a perimeter defined by the circumferential section.

[0014] In some embodiments, the tissue retraction system further includes a tissue engaging member engaged with the target tissue engaging segment of the tissue retraction device, hi some embodiments, the delivery system further includes a tissue engaging member delivery device extending into the tissue retraction device holder and spaced from the portion of the tissue retraction device engaged with the tissue retraction device holder to maintain the tissue engaging member and the target tissue engaging segment of the tissue retraction device engaged therewith.

[0015] In accordance with various principles of the present disclosure, a method of applying traction to a target tissue includes engaging a target tissue engaging segment of a tissue retraction device with the target tissue, engaging a first traction tissue engaging segment of the tissue retraction device with retracting tissue positioned at a distance from the target tissue to apply traction to the target tissue; and engaging a second traction tissue engaging segment of the tissue retraction device with retracting tissue positioned at a distance from the target tissue to change the force vector of the traction applied to the target tissue.

[0016] In some embodiments, the tissue retraction device used includes a peripheral section defining a circumference of the tissue retraction device and at least one traction tissue engaging segment extending within the circumference of the peripheral section, and the method further includes the steps of engaging a target tissue engaging segment along the peripheral section of the tissue retraction device with the target tissue; engaging a first traction tissue engaging segment of the tissue retraction device with traction tissue positioned at a distance from the target tissue to apply traction to the target tissue; and engaging a second traction tissue engaging segment of the tissue retraction device extending within the circumference of the peripheral section of the tissue retraction device with traction tissue positioned at a distance from the target tissue to change the force vector of the traction applied to the target tissue.

[0017] In some embodiments, the distance between the second traction tissue engaging segment and the target tissue is less than the distance between the first traction tissue engaging segment and the target tissue, and the method further includes engaging the first traction tissue engaging segment and the second traction tissue engaging segment with the traction tissue at the same location.

[0018] In some embodiments, engaging the second traction tissue engaging segment with the traction tissue includes engaging the second traction tissue engaging segment with traction tissue positioned away from the traction tissue with which the first traction tissue engaging segment is engaged.

[0019] In some embodiments, the method further includes delivering the tissue retraction device to the target tissue with the tissue retraction device holder maintaining a target tissue engaging segment of the tissue retraction device spaced apart from a first retracting tissue engaging segment of the tissue retraction device.

[0020] These and other features and advantages of the present disclosure will become readily apparent from the following detailed description, and the scope of the claimed invention is set forth in the appended claims. Although the following disclosure is presented in terms of aspects or embodiments, it should be understood that each aspect may be claimed separately or in combination with aspects and features of that embodiment or any other embodiment. [Brief description of the drawings]

[0021] [Figure 1] 1 illustrates an elevational view, including a detailed view of a portion of an example embodiment of a traction device and system, and an associated delivery device and system, formed in accordance with various aspects of the present disclosure. [Diagram 2] 1 illustrates a plan view of an example embodiment of a traction device formed in accordance with various principles of the present disclosure. [Diagram 3] 1 illustrates a plan view of an example embodiment of a traction device formed in accordance with various principles of the present disclosure. [Figure 4] 1 illustrates a plan view of an example embodiment of a traction device formed in accordance with various principles of the present disclosure. [Diagram 5] 1 illustrates a plan view of an example embodiment of a traction device formed in accordance with various principles of the present disclosure. [Figure 6] 1 illustrates a plan view of an example embodiment of a traction device formed in accordance with various principles of the present disclosure. [Figure 7] 1 illustrates a plan view of an example embodiment of a traction device formed in accordance with various principles of the present disclosure. [Figure 8] 1 illustrates a plan view of an example embodiment of a traction device formed in accordance with various principles of the present disclosure. [Figure 9]1 illustrates a plan view of an example embodiment of a traction device formed in accordance with various principles of the present disclosure. [Figure 10] 1 illustrates an example of an environment in which devices, systems, and methods according to various principles of the present disclosure may be used, and in which an example embodiment of a traction device and system is implemented. [Figure 11] 11 illustrates an example of an environment as in FIG. 10, in which an example embodiment of a traction device and system as in FIG. 10 is further implemented. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The accompanying drawings are provided for illustrative purposes only, and the dimensions, positions, order, and relative sizes reflected in the drawing figures may be changed. For example, a device may be enlarged so that details are discernible, but is intended to be reduced in size, for example, with respect to fitting into a working channel of a delivery catheter or endoscope. In the drawings, identical or nearly identical or equivalent elements between embodiments are typically represented by the same reference character, and similar elements are typically designated by similar reference numbers that differ in increments of 1000, and redundant descriptions are omitted. For purposes of clarity and conciseness, not all elements are labeled in every drawing, and not all elements of each embodiment are shown unless illustration is necessary to enable a person skilled in the art to understand the present disclosure.

[0023] The detailed description will be better understood in conjunction with the accompanying drawings, in which like reference characters represent like elements, as follows: The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. It should be understood that the disclosure is not limited to the specific embodiments described and may therefore be modified. All devices and systems and methods discussed herein are examples of devices and / or systems and / or methods implemented according to one or more principles of the disclosure. Each example of an embodiment is provided for illustration and is merely an example, not the only way to implement these principles. Thus, references to elements or structures or features in the drawings should be recognized as references to example embodiments of the disclosure and should not be understood as limiting the disclosure to the specific elements, structures, or features shown. Other examples of ways to implement the disclosed principles will occur to those skilled in the art upon reading this disclosure. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the scope or spirit of the inventive subject matter. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield still further embodiments. Thus, it is intended that the inventive subject matter encompass such modifications and variations as fall within the scope of the appended claims and their equivalents.

[0024] It will be understood that the present disclosure is described in this application with various levels of detail. In some cases, details that are not necessary for a person skilled in the art to understand the present disclosure or that would make it difficult for the person skilled in the art to appreciate other details may be omitted. The terms used herein are for the purpose of describing particular embodiments only and are not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, technical terms used herein should be understood as commonly understood by one of ordinary skill in the art to which the present disclosure belongs. All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure.

[0025] As used herein, "proximal" refers to a direction or location closest to a user (such as a medical professional or clinician or technician or operator or physician, such terms are used interchangeably herein without any limitation, and include automated control systems, etc.) when using the device (e.g., when introducing, implanting, positioning, or delivering the device to a patient), and / or closest to a delivery device, and "distal" refers to a direction or location furthest from a user (such as a medical professional or clinician or technician or operator or physician, such terms are used interchangeably herein without any limitation, and include automated control systems, etc.) when using the device (e.g., when introducing, implanting, positioning, or delivering the device to a patient), and / or closest to a delivery device. "Longitudinal" means extending along the longer or greater dimension of an element. "Central" means at least approximately bisecting a center point and / or approximately equidistant from a perimeter or boundary, and "central axis" means, with respect to an opening, a line at least approximately bisecting a center point of the opening, and extending longitudinally along the length of the opening if the opening comprises, for example, a tubular element, channel, cavity, or hole. As used herein, a "free end" of an element is an end of such element that does not extend beyond said free end.

[0026] The present disclosure relates to various devices, systems, and methods for applying traction to tissue within the body. Some medical procedures, including those performed along the digestive tract and / or bile duct, utilize medical devices to access tissue (e.g., "target tissue") intended for removal within the body. For example, in some current medical procedures (e.g., endoscopic submucosal dissection (ESD), endoscopic mucosal resection (EMR), peroral endoscopic myotomy (POEM), cholecystectomy, video-assisted thoracoscopic surgery (VATS)), medical professionals may use endoscopes or similar medical devices in accessing and removing lesions. The endoscope may be capable of accessing the target tissue site (the site where the target tissue is located) while also allowing various tissue manipulation devices to be deployed therethrough. Such tissue manipulation devices include, but are not limited to, devices for resecting target tissue, including, but not limited to, cutting devices, e.g., knives, scalpels, scissors, electrocautery devices, end effectors, graspers, snares, forceps, dissectors, energy-based tissue coagulators or cutters, clamps, tissue staplers, tissue loops, clip appliers, suture delivery instruments, and the like, the particular device not being critical to the present disclosure. It will be understood that terms such as medical tools, instruments, devices, and the like are not intended to be limiting and may be used interchangeably herein. Additionally, in some instances, endoscopes may incorporate features that aid medical professionals in visualizing and / or imaging tissue dissection / resection procedures, such as to facilitate performance of the procedure. For example, some endoscopes may include lights and / or cameras designed to illuminate and / or visualize the treatment site / target tissue region as the endoscope is navigated and positioned adjacent to the target tissue site. In addition, some endoscopes may also include lumens (e.g., working channels) through which additional instruments, and optionally also delivery sheaths for the instruments, may be deployed and utilized. Additional visualization methods (e.g., fluoroscopy) may alternatively or additionally be employed.For convenience, reference will be made herein to tissue resection (and other grammatical forms of tissue resection), and it will be understood that such terms are not intended to be limiting and encompass tissue incision, cutting, manipulation, etc. (and other grammatical forms of these descriptions).

[0027] Although physicians are becoming more adept at resecting lesions from within the body (such as the digestive tract, abdominal cavity, thoracic cavity, etc.), current methods of traction may continue to leave physicians inefficient. For example, in some cases, poor visualization and the ability to engage and manipulate tissue may lengthen tissue dissection procedures. It may be desirable to lift tissue, retract it out of view, or otherwise get it out of the way of the instruments used in the procedure. For example, in some EMR / ESD procedures, physicians may use separate devices to provide a means of tissue traction, such as moving tissue relative to surrounding tissue. Positioning and manipulation (e.g., traction) of resected tissue flaps during and after resection presents various challenges. Such procedures may include multiple device manipulations and / or exchanges, and associated extended procedure times. Such systems may be unable to maintain or adjust the traction or tension applied to the target tissue and / or may maintain or adjust the traction or tension applied to the target tissue in an inefficient or inconsistent manner.

[0028] In accordance with various principles of the present disclosure, tissue retraction devices are used to apply traction to tissue to facilitate the performance of procedures on such tissue. The tissue retraction device (sometimes referred to herein, for convenience and without limitation, interchangeably as a tether) may be a traction band, an elastic band, a stretchable elongated member, a wire, a cord, a cable, a spring, a suture, and / or any other suitable member that is optionally stretchable and / or extendable. The tether may advantageously be elastic and / or elastomeric (e.g., formed of rubber), although it will be understood that elasticity and / or stretchability are not necessarily aspects of the retraction device formed in accordance with various principles of the present disclosure and / or used with delivery devices and systems configured to deliver the tissue retraction device to a deployment site. The tissue retraction device is engaged with the tissue either directly or indirectly (e.g., via another element such as a tissue engagement member). It will be understood that terms such as engage (and other grammatical forms of engage) are not intended to be limiting herein and may be used interchangeably with terms such as connect, grasp, hold, fasten, clip, secure, attach, affix, fasten, etc. (and other grammatical forms thereof).

[0029] Tissue engaging members used according to various principles of the present disclosure may alternatively be referred to herein, without any intention of limitation, as tissue fasteners or clips or other mechanical fixation devices (e.g., hemostatic clips, clamps, graspers, baskets, grippers, magnets, adhesives, etc.). The tissue engaging members are optionally formed separately from the tissue retraction device. In some embodiments, the tissue engaging members are repositionable after being partially deployed. For example, the tissue engaging members may be configured to allow the tissue engaging members to be releasably engaged (e.g., closed to engage but not locked) with tissue when in a first configuration and locked out of engagement with the tissue when in a second closed configuration. In some embodiments, the tissue engaging members have grasper arms or jaws that are selectively movable away from each other to engage tissue therebetween and toward each other to grasp the engaged tissue. The gripping arms may be hinged together (e.g., as a single piece) or may be formed separately and movable relative to one another, such as by being pivotable about a pivot point. The gripping arms may have one or more additional gripping features, such as serrated or crenulated profiles or teeth, at the ends and / or along the edges of the gripping arms. In some embodiments, the tissue engaging member is movable relative to the tissue retraction device even when coupled to the tissue retraction device. Movement, such as rotation (e.g., 360° rotation), of the tissue engaging member may be controlled by a proximal control knob, dongle, or other actuator element. In some embodiments, the tissue engaging member may be manipulated, e.g., rotated, with a one-to-one correspondence between movement of the control knob and movement of the tissue engaging member. In some embodiments, the tissue engaging member is releasable from a delivery device used to deliver the tissue engaging member. For example, a frangible connection between the tissue engaging member and the delivery device may be overcome and / or a threshold pressure may be applied to separate a joined (e.g., ball and yoke) connection. It will be understood that the present disclosure is not limited to any particular form or configuration of tissue engaging members.

[0030] Tissue retraction devices known in the medical industry as well as embodiments disclosed herein can be difficult to deliver to a target tissue site. For example, some tissue retraction devices are flexible and can fold or roll on themselves, crush, crumple, wrinkle, bend, ball up, bunch, deform, distort, etc. (which can interfere or impede delivery of the tissue retraction device, such as by increasing the profile of the tissue retraction device in a narrow delivery channel), and / or the tissue retraction device can become entangled with tissue engaging members that engage tissue at the target tissue site. For convenience, and without intending to be limiting, reference is made to distorting (or other grammatical forms of the term distorting) the tissue retraction device and / or maintaining the tissue retraction device in a generally elongated configuration. It will be appreciated that reference to "generally elongated" does not necessarily require a precisely straight configuration, but rather a configuration that allows for immediate use of the tissue retraction device upon delivery to a target tissue site, as can be understood by one of skill in the art. Alternatively, or concomitantly, the generally elongated configuration of the tissue retraction device generally reduces the profile of the tissue retraction device when delivered to a target tissue site, such as through a narrow lumen of an endoscope. It will be appreciated that reference "at" a target tissue site is intended to include tissue at and adjacent the target tissue, and is not limited to only the target tissue. Delivery of a tissue retraction device can be further complicated if the tissue retraction device is elastic and / or has other properties that tend to interfere with elongating the tissue engaging members once folded upon itself or otherwise no longer elongated.

[0031] In accordance with various principles of the present disclosure, the tissue retraction device is delivered to a target tissue site with the aid of a tissue retraction device holder configured to maintain the tissue retraction device in a configuration that facilitates its use at the target tissue site, in a manner understood by those skilled in the art. More specifically, the tissue retraction device holder may be configured and / or positioned relative to the delivery device and delivery system to hold the target tissue engaging segments of the tissue retraction device spaced apart from the retracting tissue engaging segments of the tissue retraction device, such that such segments may be readily engaged with the target tissue and retracting tissue, respectively, upon delivery to the target tissue site (e.g., without manipulation of the tissue retraction device, such as from an intertwined or folded configuration). In some embodiments, the tissue retraction device is in a generally elongated configuration upon delivery, such that the tissue retraction device does not bunch up, collapse, or otherwise deform in a manner that may interfere with delivery to and use in connection with the target tissue. In some embodiments, at least a portion of the tissue retraction device is mounted or otherwise operably coupled to the tissue retraction device holder in an elongated configuration.

[0032] A delivery device, as used herein, may be of any suitable size, cross-sectional shape or area, and / or configuration that allows for the introduction and passage of a medical instrument to a target tissue site / treatment site (such terms may be used interchangeably herein, without any limitation intended). It is generally beneficial for a delivery device to be steerable, and the delivery device may have different regions of different flexibility or stiffness to facilitate steerability. A delivery device may be in the form of a flexible elongated tubular member and may include one or more working channels or lumens that extend substantially longitudinally (axially) between the proximal and distal ends of the delivery device. The term flexible elongated tubular member is used herein for convenience and without any limitation intended as an example of a general delivery device, and it will be understood that the term may be in the form of a catheter, sheath, tube, cannula, etc. (such terms are used interchangeably herein, without any limitation intended), or other configuration of an introducer. The delivery device and / or the overtube associated therewith may be made of any suitable biocompatible material known to those skilled in the art and having sufficient flexibility to traverse non-linear or tortuous anatomy. Such materials include, but are not limited to, rubber, silicone, synthetic plastics, stainless steel, metal-polymer composites; metal alloys of nickel, titanium, copper, cobalt, vanadium, chromium, and iron; superelastic or shape memory materials such as Nitinol (nickel-titanium alloy); different layers of different materials and reinforcements. Such materials may be made of or coated with polymers or lubricious materials to allow or facilitate the passage of the delivery device through the body and / or the passage of additional instruments through the working channel extending therethrough.

[0033] In accordance with various principles of the present disclosure, a tissue retraction device delivery system is configured to navigate through a body passageway (e.g., through the mouth or nose, and through the gastrointestinal system, such as through the esophagus and stomach) and deliver a tissue retraction device through the body to a target tissue site. In some embodiments, the tissue retraction device delivery system includes one or more delivery devices. The delivery device may include one or more flexible elongated tubular members. In some embodiments, the one or more flexible elongated tubular members include an endoscope with a working channel through which the tissue retraction system, including the tissue retraction device and, optionally, one or more tissue engaging members, is delivered. In some embodiments, the tissue retraction device holder is a flexible elongated tubular member within and along which the tissue retraction device is delivered. In some embodiments, the tissue engaging member is delivered at, adjacent to, along, etc., an end of the flexible elongated control member operably engaged with the tissue engaging member to control its movement (such as advancing, retracting, rotating, actuating opening and closing to grasp tissue, etc.), such as via a control handle at the proximal end of the flexible elongated control member. It will be understood that the term control (and other grammatical forms of the term control) may be used interchangeably herein with terms such as operate, move, steer, actuate, navigate, and the like (including other grammatical forms of those terms) without any limitation intended. In some embodiments, the tissue engaging member and the flexible elongate control member are delivered with a flexible elongate tubular member that movably (e.g., axially and / or rotationally) extends within the tissue retraction device holder. In embodiments in which an end of the tissue retraction device is coupled with the tissue engaging member, the tissue retraction device may extend distally from the tissue engaging member within or along the tissue retraction device holder and be operably coupled with the tissue retraction device holder at another end or location along the tissue retraction device.

[0034] In some embodiments, the tissue retraction device is delivered to the target tissue site with a tissue engaging member coupled thereto. In some embodiments, the tissue retraction device extends from the tissue engaging member to the tissue retraction device holder. For example, the tissue engaging member may be coupled with a first end of the tissue retraction device, and the second end of the tissue retraction device may be operably engaged with the tissue retraction device holder (such as at a location spaced apart from the tissue engaging member) to prevent the tissue retraction device from being distorted. It should be understood that references to the first end or second end of the tissue retraction device are for brevity and should not be understood as being limited to the ends of the elongated element, but may also apply to other locations along the elongated element. By extending the tissue retraction device from the tissue engaging member to the tissue retraction device holder, the tissue retraction device is maintained in a generally elongated configuration that facilitates its delivery and deployment (e.g., during introduction and movement through a delivery device such as a flexible tubular element) and attachment to tissue at the target tissue site. In some embodiments, the tissue retraction device holder extends distally beyond the delivery device, such as distal to the tissue engaging member, thereby holding the tissue retraction device extended during delivery. Such a configuration, which may be considered a "slingshot" configuration, may offer advantages over back-loaded devices that may take more time to assemble for delivery of the tissue retraction device to the target tissue site.

[0035] When the tissue retraction device is delivered to the target tissue site, the first section of the tissue retraction device is engaged with tissue at the target tissue site, such as by use of an initial or first tissue engaging member (optionally preloaded or otherwise coupled to the tissue retraction device prior to delivery to the target tissue site). For convenience, and without any intention of limitation, the tissue initially engaged by the tissue retraction device is referred to herein as the target tissue, although tissue other than the target tissue may instead be initially engaged. The retraction section of the tissue retraction device is then engaged with tissue remote from the target tissue (which is referred to herein, and without any intention of limitation, as the initial retraction tissue site), such as in a manner that allows the tissue retraction device to apply traction to the target tissue. A second tissue engaging member may be used to engage the retraction section of the tissue retraction device with the retraction tissue site. As the target tissue is moved relative to the surrounding tissue (e.g., cut relative to the surrounding tissue), the traction force applied thereto may be reduced. In accordance with various principles of the present disclosure, rather than moving a retraction section of the tissue retraction device to increase tension on the target tissue, another / further retraction section is engaged with tissue at another / further retraction tissue site remote from the initial retraction tissue site to increase the retraction force applied to the target tissue site. A third tissue engaging member may be used to engage the additional retraction section of the tissue retraction device with the additional retraction tissue site. The additional retraction section of the tissue retraction device may be engaged with additional retraction tissue sites that are increasingly farther away from the target tissue.

[0036] In accordance with various principles of the present disclosure, tissue retraction devices are shaped to allow for different attachment points of the tissue retraction device to tissue, such as by use of tissue engaging members. For example, in some embodiments, tissue retraction devices formed in accordance with various principles of the present disclosure have two or more gripping sections or segments that are distinct from another gripping section or segment. It will be understood that terms such as section or segment or area or portion may be used interchangeably herein without any limitation intended. For convenience of distinction, different sections of a tissue retraction device may be distinguished from one another by reference to different gripping "segments" defined along a section of the tissue retraction device, such as by differences in shape or orientation relative to another gripping segment of the tissue retraction device (such as, but not limited to, adjacent to a gripping segment). In one aspect, a tissue retraction device may be formed in accordance with various principles of the present disclosure with an outer or peripheral section defining one or more gripping segments along therewith, and one or more gripping segments within an interior region or periphery of the peripheral section. The target tissue engaging segment may be identified as the portion attached to the target tissue against which the traction force is applied (e.g., along a portion of the circumferential section of the tissue retraction device, or optionally along a section within the periphery of the circumferential section). The additional gripping segments may be defined by sections of the tissue retraction device along and / or within the periphery of the circumferential section of the tissue retraction device. One or more additional gripping segments may engage a retracting tissue site (the same or a different site than the initially engaged retracting tissue), and such gripping segments are referred to herein as retracting tissue engaging segments for convenience (e.g., to distinguish from the target tissue engaging segment), without any intent to be limiting.Tissue retraction devices formed in accordance with various principles of the present disclosure thus provide multiple grasping segments or holding locations for a medical professional to grasp, manipulate, and / or engage the tissue retraction device with selected regions of tissue along a tissue target site (e.g., target tissue or retracted tissue), thereby improving the utility of the tissue retraction device.

[0037] In some embodiments, the circumferential section of the tissue retraction device formed according to various principles of the present disclosure is in the shape of a loop. In some embodiments, the loop is elliptical. In some embodiments, one or more additional sections, such as in the form of an additional loop, are formed within the circumferential section. For example, in some embodiments, a loop (such as a circle) may be formed along one or both of the foci of the circumferential section in the form of an ellipse. In some embodiments, the additional section is formed by another segment (straight or curved) extending within the circumferential section, such as extending across the circumferential section (e.g., across the direction of extension of the circumferential section in the direction between the target tissue and the retracting tissue).

[0038] Tissue retraction devices formed according to various principles of the present disclosure provide medical professionals with multiple points at which the tissue retraction device may be coupled (such as with one or more tissue engaging members) to tissue spaced apart from the target tissue to vary or adjust the force vector applied to the target tissue to impart a traction force to the target tissue. For example, engaging a first segment of the tissue retraction device to a first region of the tissue (such as, but not limited to, the target tissue) and then engaging (sequentially or simultaneously) different segments of the tissue retraction device to different regions of the tissue spaced apart from the first region of the tissue allows various degrees or strengths and / or various angles of traction to be imparted to the target tissue. If the medical professional needs to engage a first segment of the tissue retraction device with a first tissue site, engage a second segment of the tissue retraction device with a second tissue site, and then adjust the traction on the first tissue site (e.g., apply additional, greater traction to the first tissue site or apply traction at a different angle), a third segment of the tissue retraction device may be engaged with the third tissue site to apply a greater amount of traction to the first tissue site (such as when the distance between the third segment and the first segment is less than the distance between the second segment and the first segment) and / or change the angle at which traction is applied to the first tissue site. It will be understood that the second and third tissue sites may be considered traction tissue sites. It will be further understood that the second and third segments of the tissue retraction device may be of different lengths such that engagement of such segments with the same traction tissue site applies traction with different force vectors to the target tissue. In some embodiments, the tissue retraction device is made from an elastomeric material that will, when properly placed, apply a traction force to the tissue with which it is engaged. In some embodiments, the tissue retraction device is elastic. In some embodiments, the tissue retraction device is stretchable to apply traction to tissue at the target tissue site.

[0039] Various embodiments of tissue retraction devices and systems, and associated methods, and tissue retraction delivery devices and systems, and associated methods will now be described with reference to examples illustrated in the accompanying drawings. References herein to "one embodiment," "one embodiment," "several embodiments," "other embodiments," and the like indicate that one or more particular features, structures, and / or characteristics in accordance with the principles of the present disclosure may be included in connection with the embodiments. However, such references do not necessarily mean that all embodiments include the particular features, structures, and / or characteristics, or that the embodiments include all features, structures, and / or characteristics. Some embodiments may include one or more such features, structures, and / or characteristics in various combinations thereof. Moreover, references in various places herein to "one embodiment," "one embodiment," "several embodiments," "other embodiments," and the like do not necessarily all refer to the same embodiment, and separate or alternative embodiments do not necessarily mutually exclude other embodiments. It is to be understood that when a particular feature, structure, and / or characteristic is described in connection with one embodiment, such feature, structure, and / or characteristic may be used in connection with other embodiments, whether or not expressly described, unless expressly stated to the contrary. It is further to be understood that such features, structures, and / or characteristics may be used or exist alone or in various combinations with each other to create alternative embodiments that are considered part of this disclosure, since it would be very cumbersome to describe all of the many possible combinations and subcombinations of features, structures, and / or characteristics. Furthermore, various features, structures, and / or characteristics are described that may be exhibited by some embodiments but not by other embodiments. Similarly, various features, structures, and / or characteristics or requirements are described that may be features, structures, and / or characteristics or requirements for some embodiments but may not be features, structures, and / or characteristics or requirements for other embodiments.Accordingly, the present disclosure is not limited to only the embodiments specifically described herein, and the example embodiments disclosed herein are not intended as limiting the broader aspects of the present disclosure.

[0040] Referring now to the drawings, it will be understood that common features are identified by common reference elements, and for brevity and convenience, without intent to be limiting, descriptions of common features will generally not be repeated. For clarity, not all components with the same reference numbers are numbered. It will be understood that in the following description, similar elements or components among the various illustrated embodiments of the tissue engaging member will generally be designated with the same reference numbers incremented by a multiple of 1000, and redundant descriptions will generally be omitted for brevity. Furthermore, certain features in one embodiment of the tissue engaging member may be used across different embodiments of the tissue engaging member and will not necessarily be individually labeled when appearing in different embodiments.

[0041] An example embodiment of a delivery system 1000 formed according to various principles of the present disclosure for delivering a tissue retraction system 2000 is shown in FIG. The tissue retraction system 2000 includes a tissue retraction device 2100 and a tissue engaging member 2200 by which the tissue retraction device 2100 can be engaged with tissue at a target tissue site. The delivery system 1000 includes a tissue retraction device holder 1100 configured to maintain the tissue retraction device 2100 in a delivery configuration and a tissue engaging member delivery device 1200 configured to deliver the tissue engaging member 2200. In the illustrated example of the embodiment, the tissue engaging member delivery device 1200 includes a flexible elongated tubular member 1210 through which the tissue engaging member 2200 is delivered. The flexible elongated tubular member 1210 is referred to herein for clarity, but not by way of limitation, as a tissue engaging member shaft 1210. In some embodiments, the distal end 1211 of the tissue engaging member shaft 1210 is operably coupled to the proximal end 2203 of the tissue engaging member 2200, and the distal end 2201 of the tissue engaging member 2200 is operably coupled to the proximal end 2203 of the tissue engaging member 2200. The tissue engaging member 2200 may be delivered within a lumen defined within the tissue engaging member shaft 1210, or at least a portion of the tissue engaging member 2200 may extend distally outside the tissue engaging member shaft 1210. In the latter case, the tissue retraction device holder 1100 may extend over the tissue engaging member shaft 1210 and the tissue engaging member 2200 and may shield the tissue engaging member 2200 (particularly its gripping arms 2210) from the interior of another flexible elongated tubular member through which the tissue engaging member delivery device 1200 is delivered. For example, the tissue retraction device holder 1110 may be in the form of a flexible, elongated tubular member that extends over the tissue engaging member shaft 1210. The tissue retraction device holder 1100 and tissue engaging member shaft 1210 may be delivered within another delivery member, such as another flexible, elongated tubular member as known to those skilled in the art.For example, the tissue retraction device holder 1100 and tissue engagement member shaft 1210 may be delivered within a working channel of an endoscope 1300 (as known to those skilled in the art, the configuration of which does not form part of this disclosure) as illustrated in Figures 10 and 11, as discussed in further detail below, and / or within a further delivery shaft (such as in the form of a flexible elongated tubular member).

[0042] As can be understood with reference to FIG. 1 , a portion of the tissue retraction device 2100 may be coupled to the tissue engaging member 2200. The tissue engaging member 2200 may be engaged with tissue at a target tissue site, and the portion of the tissue retraction device 2100 coupled thereto may thereby be coupled to tissue at the target tissue site as well. Another portion of the tissue retraction device 2100, spaced from the portion engaged with the tissue engaging member 2200, engages a portion of the tissue retraction device holder 1100 and is held by the tissue retraction device holder 1100 in a configuration that facilitates delivery of the tissue retraction device 2100 to the target tissue site. For example, the tissue retraction device holder 1100 may hold the tissue retraction device 2100 in a configuration (such as a generally elongated configuration) that facilitates deployment of the tissue retraction device 2100. In the illustrated embodiment, the tissue retraction device 2100 is extended distally such that an anchoring portion of the tissue retraction device 2100 (spaced apart from the tissue engaging portion) engages a portion of the tissue retraction device holder 1100, such as the distal end 1101 of the tissue retraction device holder 1100. Thus, the section of the tissue retraction device 2100 that is engaged with the retracted tissue may be maintained spaced apart from the section of the tissue retraction device 2100 that is engaged with the target tissue. However, other configurations and / or arrangements of the tissue retraction device 2100 relative to the tissue retraction device holder 1100 are within the scope and spirit of the present disclosure.

[0043] In some embodiments, the tissue retraction device holder 1100 has a size, shape, configuration, and / or dimensions to engage (e.g., operatively couple) a portion of the tissue retraction device 2100 and hold the tissue retraction device 2100 in place relative to the tissue retraction device holder 1100. Such a structure is conveniently referred to herein as a connector 1110, and may be a shoulder, a cut-out section, a post, a rail, a slat, a protrusion, a hook, a ledge, or other structure known to those skilled in the art as a connector. In the example embodiment shown in FIG. 1, the connector 110 is in the form of two or more slits 1115 that define a rail 1114 therebetween in the distal end 1101 of the tissue retraction device holder 1100. A portion of the tissue retraction device 2100 may be inserted into one or both slits 1115. For example, the tissue retraction device 2100, at least a portion of which comprises a form of a loop, may be hooked around the rail 1114 defined by the slits 1115. It will be understood that configurations of coupler 1110 other than that shown in FIG. 1 are within the scope and spirit of the present disclosure.

[0044] In some embodiments, the tissue engaging member 2200 is an adjustable clip (such as a hemostatic clip) having first and second gripping arms 2210 (which may alternatively be referred to herein as jaws, without intending to be limiting) movable relative to one another between an open configuration and a closed configuration. In the open configuration, tissue may be positioned between the gripping arms 2210 to be engaged by the gripping arms 2210. In the closed configuration, the gripping arms 2210 engage or hold tissue therebetween. The gripping arms 2210 may be delivered by the tissue engaging member delivery device 1200 in a closed configuration that is generally more compact than the open configuration, although the present disclosure need not be so limited. The tissue engaging member 2200 may be configured to engage tissue at a target tissue site TS (as illustrated in FIGS. 10 and 11 and discussed in further detail below), as well as to engage a tissue engaging portion of the tissue retraction device 2100. Thus, the tissue engaging portion of the tissue retraction device 2100 need not directly engage tissue, but may engage tissue at the target tissue site via the tissue engaging members 2200.

[0045] In some embodiments, the tissue engaging member delivery device 1200 includes a tissue engaging member controller 1210 that engages the tissue engaging member 2200 (e.g., the proximal end 2203 of the tissue engaging member 2200) and controls the movement of the gripping arms 2210 relative to one another. In some embodiments, the tissue engaging member 2200 is slidable within the capsule 2220 (a tubular element having a lumen defined therein), and the gripping arms 2210 may be biased apart such that the gripping arms 2210 are in an open configuration when the gripping arms 2210 are extended distally outside the capsule 2220. The gripping arms 2210 may be configured to transition to a closed configuration when at least partially withdrawn into the capsule 2220, generally leaving their distal ends 2211 outside the capsule 2220 (such as when engaging tissue such that the tissue does not extend into the capsule 2220). The controller 1210 may be a flexible elongate member, such as a control wire, that may extend proximally from the tissue engaging member 2200 to a proximal location outside the body where the controller 1210 can be manipulated to move (e.g., translate axially, rotate, etc.) the tissue engaging member 2200. For example, distal advancement of the controller 1210 advances the tissue engaging member 2200 out of the capsule 2220 allowing the gripping arms 2210 to move to an open configuration allowing tissue to be positioned therebetween, and proximal retraction of the controller 1210 retracts the tissue engaging member 2200 into the capsule 2220 shifting the gripping arms 2210 to a closed configuration gripping tissue therebetween. A variety of structures and features may be provided as known to those of skill in the art to prevent the gripping arms 2210 from being pushed out of the capsule 2220 and / or to prevent the gripping arms 2210 from being pulled too far into the capsule 2220 (e.g., pulling on the gripped tissue therein), and the present disclosure is not limited by such structures or features. Additionally, any of a variety of locking features may be provided as known to those of skill in the art to hold the gripping arms 2210 in a desired open or closed configuration, and the present disclosure is not limited by such structures or features.Once the gripping arms 2210 of the tissue engaging member 2200 have engaged tissue in a desired manner and / or are in a desired configuration, the controller 1210 can be separated (e.g., detached) from the tissue engaging member 2200, leaving the tissue engaging member 2200 in place engaging tissue in a desired manner. Any of a variety of configurations and methods of separating such components known or heretofore known in the art may be used without affecting the scope of the present disclosure.

[0046] In the example embodiment of the delivery system 1000 shown in FIG. 1 , the delivery and deployment of the tissue retraction device 2100 and tissue engagement member 2200 at the distal end 1001 of the delivery system 1000 is controlled or actuated by a control handle 1230 at the proximal end 1003 of the delivery system 1000. The illustrated example of an embodiment of the control handle 1230 includes a handle body 1232 that is graspable by a medical professional and, optionally, includes a thumb ring 1234. The illustrated example of an embodiment of the control handle 1230 also includes a slider 1236 coupled to the controller 1210 to effect movement of the controller 1210 and, therefore, movement of the tissue engagement member 2200. For example, the slider 1236 may be slidable relative to the control handle 1230 to advance or retract the controller 1210, and thus the gripping arm 2210, relative to the capsule 2220 to shift the gripping arm 2210 between an open configuration and a closed configuration. It should be understood that various configurations of control handles and manners of delivering tissue retraction device 2100 formed in accordance with various principles of the present disclosure, optionally together with tissue retraction device holder 1100 formed in accordance with various principles of the present disclosure, are within the scope of the present disclosure and the particular configuration is not critical to the present disclosure.

[0047] In accordance with various principles of the present disclosure, any of a variety of tissue retraction devices may be delivered by a delivery system 1000 utilizing a tissue retraction device holder 1100 as illustrated in FIG. 1. In some embodiments, the tissue retraction device 2100 includes two or more regions or portions or sections that are engageable with tissue, a tissue engaging member 2200, or another element, such as the tissue retraction device holder 1100. For example, the tissue retraction device 2100 may include a target tissue engaging segment 2112 configured to be engaged with a target tissue to which a traction force is to be applied. As described above, such a target tissue engaging segment 2112 may be delivered with the tissue engaging member 2200 already engaged for use in engaging the target tissue with the target tissue. Another portion of the tissue retraction device 2100 may be engaged with the tissue retraction device holder 1100 during delivery to a target tissue site, as described above.

[0048] In accordance with various principles of the present disclosure, the tissue retraction device may include two or more portions capable of engaging tissue, whether delivered with the assistance of the tissue retraction device holder 1100 or not. Such portions of the tissue retraction device may be referred to as tissue engaging portions, without intending to be limiting. It will be understood that the term engage (and other grammatical forms of the term) may be used interchangeably herein with other terms, such as couple, affix, anchor, secure, attach, etc.

[0049] It will be understood that terms such as portion, area, section, segment, and the like may be used interchangeably herein without any limitation intended, and for ease of distinction, reference will generally be made to section as a general area and segment as a specific portion, without any limitation intended. Various embodiments of tissue retraction devices 2100, 3100, 4100, 5100, 6100, 7100, 8100, 9100, respectively, and formed in accordance with various principles of the present disclosure, include peripheral sections providing multiple gripping segments therealong. and one or more further gripping segments 2120, 3120, 4120, 4122, 5120, 5122, 6120, 6122, 7120, 8120, 9120, 9122, which may be considered to be internal gripping segments (at least for convenience, such as to distinguish from the description of the circumferential sections, and not intended to be limiting) within the perimeter of the circumferential sections 2110, 3110, 4110, 5110, 6110, 7110, 8110, 9110. In some embodiments, tissue retraction devices 2100, 3100, 4100, 5100, 6100, 7100, 8100, 9100 are generally elongated and have an "end" that generally engages the target tissue and another section that engages tissue spaced from the target tissue (and, optionally, at another "end" of the elongated tissue retraction device or between the ends of the elongated tissue retraction device), and can be considered, for example, to anchor such tissue (which for convenience and distinction, may be referred to as "retraction tissue") and apply a traction force to the target tissue.The end of the tissue retraction device that engages the target tissue may be referred to herein (for convenience and not intended to be limiting) as the target-tissue-engaging end, and the end of the tissue retraction device that engages the traction tissue (e.g., to anchor thereto and apply a traction force to the target tissue) may be referred to herein (for convenience and not intended to be limiting) as the traction-tissue-engaging end.

[0050] In some embodiments, the peripheral sections 2110, 3110, 4110, 5110, 6110, 7110, 8110, 9110 of each tissue retraction device 2100, 3100, 4100, 5100, 6100, 7100, 8100, 9100 formed according to various principles of the present disclosure may be in the form of a loop, such as in the form of a circle or an ellipse, as illustrated in Figures 2, 3, 4, 5, 6, 7, 8, and 9, respectively. The peripheral sections 2110, 3110, 4110, 5110, 6110, 7110, 8110, 9110 may be engaged with the target tissue along their segments, such as via respective target tissue engaging segments 2112, 3112, 4112, 5112, 6112, 7112, 8112, 9112 along their respective first ends 2111, 3111, 4111, 5111, 6111, 7111, 8111, 9111. If the circumferential section 2110, 3110, 4110, 5110, 6110, 7110, 8110, 9110 is in the form of an ellipse, the target tissue engaging segment 2112, 3112, 4112, 5112, 6112, 7112, 8112, 9112 may be disposed along a first focus of such ellipse. Another segment of the tissue retraction device 2100, 3100, 4100, 5100, 6100, 7100, 8100, 9100 may engage tissue spaced apart from the target tissue, such as to anchor such other segment to the other tissue. Thus, the other tissue may be considered a retracting tissue, and the other segment may be considered a retracting tissue engaging segment. Such engagement of the target tissue engaging segment 2112, 3112, 4112, 5112, 6112, 7112, 8112, 9112 of the tissue retraction device 2100, 3100, 4100, 5100, 6100, 7100, 8100, 9100 with the target tissue enables the tissue retraction device 2100, 3100, 4100, 5100, 6100, 7100, 8100, 9100 to apply a traction force to the target tissue with which the target tissue engaging segment 2112, 3112, 4112, 5112, 6112, 7112, 8112, 9112 of the tissue retraction device 2100, 3100, 4100, 5100, 6100, 7100, 8100, 9100 is engaged.Such traction tissue engaging segments may be present along the outer circumferential sections 2110, 3110, 4110, 5110, 6110, 7110, 8110, 9110, such as the outer circumferential traction tissue engaging segments 2114, 3114, 4114, 5114, 6114, 7114, 8114, 9114, or along segments within the outer periphery or interior (e.g., bounded by or otherwise radially inwardly) of the outer circumferential sections 2110, 3110, 4110, 5110, 6110, 7110, 8110, 9110. In some embodiments, the target tissue engaging segment 2112, 3112, 4112, 5112, 6112, 7112, 8112, 9112 is along the second end 2113, 3113, 4113, 5113, 6113, 7113, 8113, 9113 of the circumferential section 2110, 3110, 4110, 5110, 6110, 7110, 8110, 9110, although other locations are within the scope and spirit of the present disclosure.

[0051] In accordance with various principles of the present disclosure, the tissue retraction device has two or more traction tissue-engaging segments to allow a medical professional to vary or adjust the force vector of traction applied to the target tissue by the tissue retraction device. For example, the tissue retraction device engaged with the target tissue may be grasped along an initial, first traction tissue-engaging segment and engaged (e.g., anchored) to a retraction tissue spaced from the target tissue. As the target tissue is resected or dissected or otherwise moved relative to the surrounding tissue at the target tissue site, the traction force applied by the tissue retraction device may be reduced. Instead of moving the initial traction tissue-engaging segment of the tissue retraction device (as in prior art procedures) to maintain a constant amount of traction on the target tissue, one or more gripping segments of the tissue retraction device may be simultaneously and / or sequentially engaged with the retraction tissue spaced from the target tissue. When the distance between the retraction tissue and each of the traction tissue-engaging segments is different, one or more traction tissue-engaging segments may be engaged with the same traction tissue to vary the force vector of traction applied to the target tissue. Alternatively, or additionally, additional retracting tissue-engaging segments may be engaged with different retracting tissue sites that are spaced apart from one another. Such other retracting tissue-engaging segments of the tissue retraction device may be along the perimeter section of the tissue retraction device and / or along the interior of the perimeter section, or otherwise. For example, tissue retraction devices 2100, 3100, 4100, 5100, 6100, 7100, 8100, 9100 shown in Figures 2, 3, 4, 5, 6, 7, 8, and 9, respectively, each include a peripheral section 2110, 3110, 4110, 5110, 6110, 7110, 8110, 9110 with one or more additional gripping segments 2120, 3120, 4120, 4122, 5120, 5122, 6120, 6122, 7120, 8120, 9120, 9122 as defined herein that may be used as a target tissue engagement segment.

[0052] 2 and 3, respectively, the additional gripping segment 2120, 3120 is in the form of a loop defined adjacent (e.g., around) a focal point of the elliptically shaped circumferential section 2110, 3110 adjacent the target tissue engaging segment 2112, 3112. When the additional gripping segment 2120, 3120 is engaged (e.g., using a different tissue engaging member) with a retracting tissue that is the same as or spaced apart from the target tissue with which the tissue retraction device 2100, 3100 is initially engaged (the "initial target tissue" at the "initial retraction tissue site"), the tissue retraction device 2100, 3100 may change the force vector of the traction applied to the target tissue and / or adjust the angle of traction applied to the target tissue. The additional gripping segments 2120, 3120 are illustrated as being within the circumferential section 2110, 3110 of the tissue retraction device 2100, 3100, although other locations are within the scope and spirit of the present disclosure.

[0053] The example embodiment of tissue retraction device 4100, 5100 shown in Figures 4 and 5, respectively, also has an additional gripping segment 4120, 5120 in the form of a loop defined adjacent (e.g., around) the focal point of the elliptically shaped circumferential section 4110, 5110 adjacent the target tissue engaging segment 4112, 5112. Similar to the tissue retraction devices 2100, 3100 of Figures 2 and 3, respectively, having similar gripping segments 2120, 3120, engagement of the additional gripping segment 4120, 5120 of tissue retraction device 4100, 5100 with retracted tissue that is the same as or spaced from the initially retracted tissue allows the respective tissue retraction device 4100, 5100 to change the force vector of the traction applied to the target tissue. In addition, the tissue retraction device 4100, 5100 has an additional gripping segment 4122, 5122 (which may also be in the form of a loop) spaced apart from the target tissue engaging segment 4112, 5112. For example, the additional gripping segment 4122, 5122 may be defined adjacent (e.g., around) the other focal point of the elliptically shaped circumferential section 4110, 5110. Such additional gripping segment 4122, 5122 allows the respective tissue retraction device 4100, 5100 to further grasp and engage with the additional retracted tissue site, further changing the force vector of the traction applied by the tissue retraction device 4100, 5100 to the target tissue. Although the additional gripping segment 4122, 5122 is illustrated as being within the circumferential section 4110, 5110 of the tissue retraction device 4100, 5100, other locations are within the scope and spirit of the present disclosure.

[0054] It will be understood that additional gripping segments may be located at other locations within or along the circumferential section of the tissue retraction device. For example, as illustrated in FIG. 6, the tissue retraction device 6100 may have one or more gripping segments 6120, 6122 extending along a common vertex of the elliptically shaped circumferential section 6110 (generally along a longer section of the ellipse extending in the direction of the major axis of the ellipse). Although the additional gripping segments 6120, 6122 are illustrated as being within the circumferential section 6110 of the tissue retraction device 6100, other locations are within the scope and spirit of the present disclosure.

[0055] It will be further understood that the additional gripping or retracting segment may be in a form other than a loop. In some embodiments, the additional retraction segment extends transversely to the direction of extension of the tissue retraction device between the target tissue and the retracting tissue. For example, as shown in FIG. 7, a tissue retraction device 7100 may be formed with an additional gripping segment 7120 that extends transversely to the direction in which the tissue retraction device 7100 extends between the target tissue and the retracting tissue in accordance with various principles of the present disclosure. For example, in the example embodiment of the tissue retraction device 7100 shown in FIG. 7, the additional gripping segment 7120 extends transversely to the interior of the circumferential section 7110 of the tissue retraction device 7100. Although the internal gripping segment 7120 of the tissue retraction device 7100 is shown as generally straight and extending generally along the minor axis of the circumferential section 7110 in the form of an ellipse, tissue retraction devices with internal gripping segments of other shapes and configurations and orientations within the circumferential section, which may be, but are not limited to, an elliptical shape, are within the scope and spirit of the present disclosure.

[0056] As can be understood with reference to the example embodiments of tissue retraction devices 8100, 9100 shown in Figures 8 and 9, respectively, in accordance with various principles of the present disclosure, the thickness of one or more sections of a tissue retraction device formed in accordance with various principles of the present disclosure need not be the same. For example, thicker areas or regions 8130, 9130, 9132 may be provided to increase the resistance to elongation of such regions, such as to increase the traction force imparted by the segments along such sections. In the example embodiment of tissue retraction device 8100 shown in Figure 8, the target tissue engaging segment 8112 and the internal gripping segment 8120 extending across the interior of the circumferential section 8110 extend along the thicker region 8130 of the tissue retraction device 8100. The internal gripping segment 8120 may extend along the minor axis of the circumferential section 8110 or may be slightly offset from the minor axis (e.g., as shown), and may optionally be curved to form a loop configuration. 9, the target tissue engaging segment 9112 and the two internal gripping segments 9120, 9122, which extend across the interior of the circumferential section 9110, extend along a thicker region 9130 of the tissue retraction device 9100. The two internal gripping segments 9120, 9122 are shown as being in the form of a loop, such as approximately along the end of the elongated circumferential section, although it will be understood that other configurations, including but not limited to, approximately straight segments, are within the scope and spirit of the present disclosure.

[0057] In some embodiments, a tissue retraction device formed according to various principles of the present disclosure is configured to facilitate mating of the tissue retraction device with a separately formed tissue engaging member. The tissue retraction device and / or tissue engaging member may be configured to hold the tissue retraction device in a fixed position relative to the tissue engaging member. In some embodiments, the tissue retraction device includes one or more assembly holes in which the tissue engaging member may be engaged. For example, a tissue engaging member having a pair of gripping arms 2210 as shown in FIG. 1 may be engaged with the tissue retraction device by introducing at least one of the gripping arms 2210 into the assembly hole with an interference fit due to friction of the tissue retraction device and elastomeric material shrinking into the gripping arms 2210, etc. Such a fit ensures that the tissue retraction device remains in a fixed position during the procedure. The gripping arms 2210 may be shaped and / or configured (e.g., have shoulders) to hold the tissue retraction device in place relative to the tissue engaging member and resist inadvertent withdrawal of the gripping arms 2210 from the assembly hole. In the example embodiment of the tissue retraction device 2100, 4100 shown in Figures 2 and 4, a pair of assembly holes 2140, 4140 are provided along the respective target tissue engaging segments 2112, 4112 of the tissue retraction device 2100, 4100, respectively. Each of the gripping arms 2210 of the tissue engagement member 2200 as shown in Figure 1 may be inserted into the respective holes 2140, 4140 of the pair of assembly holes 2140, 4140. It will be appreciated that the provision of at least one assembly hole can be modified to include only one assembly hole, simplifying the process of inserting only one gripping arm of the tissue engagement member into the assembly hole of the tissue retraction device to couple the tissue retraction device with the tissue engagement member. Such configurations and couplings may be advantageously used when backloading the tissue retraction device into a delivery device and / or when not using the tissue retraction device holder 1100 as described above.Example embodiments of tissue retraction devices 3100, 5100, 6100, 7100, 8100, 9100 are illustrated with only a single assembly hole 3140, 5140, 6140, 7140, 8140, 9140 adjacent a target tissue engaging segment 3112, 5112, 6112, 7112, 8112, 9112 of the tissue retraction device 3100, 5100, 6100, 7100, 8100, 9100, respectively. It will be understood that other configurations are within the scope and spirit of the present disclosure. For example, if it is desired to preload additional tissue engaging members to be engaged with the tissue retraction device, additional assembly holes may be provided for such additional tissue engaging members.

[0058] As previously mentioned, a segment of a tissue retraction device formed according to various principles of the present disclosure may be engaged with an initial tissue site (conveniently and without limitation referred to as a target tissue), such as with a tissue engagement member (optionally preloaded on the tissue retraction device), and then another segment of the tissue retraction device may be engaged with another region of tissue (conveniently and without limitation referred to herein as a retracted tissue and / or retracted tissue site) to apply a traction force to the target tissue via the tissue retraction device. The target tissue site may be within a body passageway or lumen (such as, but not limited to, the gastrointestinal tract, such as the small intestine or large intestine), and the retracted tissue is along the wall of the body passageway or lumen opposite the target tissue. Of course, it will be understood that devices, systems and methods according to various principles of the present disclosure may be used in connection with other anatomical regions and / or structures.

[0059] An example of using an example embodiment of a tissue retraction device 2100 according to various principles of the present disclosure is shown in FIG. 10 and FIG. 11. An example embodiment of a tissue retraction device 2100 is shown in FIG. 10 engaged with a target tissue TA at a target tissue site TS using a tissue engaging member 2200. More specifically, to couple the tissue retraction device 2100 to the target tissue TA, the gripping arm 2210 of the tissue engaging member 2200 is inserted through an assembly hole 2140 (see FIG. 2) adjacent the target tissue engaging segment 2112. The circumferential retracting tissue engaging segment 2114 is spaced apart from the target tissue engaging segment 2112 along the circumferential section 2110 of the tissue retraction device 2100 and engaged with a retracted tissue TR1 spaced apart from the target tissue TA using another tissue engaging member 2202. The tissue retraction device 2100 may thereby apply a traction force to the target tissue TA. The endoscope 1300 is shown delivering the tissue manipulation device 1400 to the target tissue site TS to manipulate the target tissue TA to which traction is being applied by the tissue retraction device 2100. In the illustrated example, the tissue manipulation device 1400 separates the target tissue TA from the surrounding tissue at the target tissue site TS. As the target tissue TA is separated from the surrounding tissue, the target tissue TA is lifted away from the surrounding tissue at the target tissue site TS, relieving a portion of the traction exerted by the tissue retraction device 2100.

[0060] 11, to increase the traction force on the target tissue TA, the inner gripping segment 2120 is engaged, such as using an additional tissue engaging member 2204, and the retracted tissue TR2 is moved away from the retracted tissue TR1 engaged by the traction tissue engaging segment 2114. As can be appreciated, the additional traction force on the target tissue TA lifts the target tissue TA further away from the surrounding tissue, allowing the procedure being performed with the tissue manipulation device 1400 to continue without interference by the target tissue TA. It will be appreciated that if the distance between the inner gripping segment 2120 and the target tissue TA is less than the distance between the traction tissue engaging segment 2114 and the target tissue TA, engagement of the inner gripping segment 2120 with the same retracted tissue T1 with which the traction tissue engaging segment 2114 is engaged may still change the force vector of traction applied to the target tissue TA by the tissue retraction device 2100.

[0061] The tissue retraction device 2100 shown in Figures 10 and 11 appears similar to the tissue retraction device 2100 illustrated in Figure 2, however it will be understood that other configurations of tissue retraction devices (including but not limited to tissue retraction devices 3100, 4100, 5100, 6100, 7100, 8100, 9100 shown in Figures 3, 4, 5, 6, 7, 8, and 9, respectively) may be used as described.

[0062] The foregoing examples of tissue retraction device 2100, 3100, 4100, 5100, 6100, 7100, 8100, 9100 embodiments illustrate examples of various principles of the present disclosure, and it will be understood that the present disclosure is not limited by such examples. The various structures and features of the embodiments described herein and shown in the figures have several separate and independent inherent advantages. Thus, the various structures and features described herein need not all be present to achieve at least some of the desired properties and / or advantages described herein. Furthermore, the various features described herein may be used alone or in any combination. It will be understood that the various features described with respect to one embodiment may be applied to another embodiment, whether or not explicitly shown. Thus, it should be understood that one or more of the features described with reference to one embodiment can be combined with one or more of the features of any of the other embodiments described herein. That is, any of the features described herein may be combined and adapted to create a hybrid design, and such hybrid designs are within the scope of the present disclosure. Accordingly, the present invention is not limited to only those embodiments specifically described herein. The foregoing descriptions are merely illustrative examples of embodiments and are not intended as limiting the broader aspects of the present disclosure.

[0063] It should be understood that surgical incision or resection of a target tissue as discussed herein typically includes removal of a portion of surrounding healthy tissue along the target tissue margin to ensure complete removal and minimize the possibility of metastasis of remaining or removed target tissue cells to other locations in the body. The target tissue may be within a target tissue area of ​​the body, such as the gastrointestinal system. Terms such as target tissue area, target tissue site, target area of ​​tissue, target area, target site, target treatment area, treatment area, target treatment site, treatment site, and the like may be used interchangeably herein to refer to an area or region of tissue that is treated or otherwise operated on or affected by the devices and / or systems and / or methods disclosed herein, without intending to be limiting, and include areas or regions that extend outward from the target tissue (a particular tissue within the target tissue area), or that extend around the target tissue, or that surround the target tissue. The various principles of the present disclosure are, of course, applicable more broadly beyond tissue resection / incision.

[0064] It will be understood that other uses of tissue engaging members formed according to various principles of the present disclosure are within the scope and spirit of the present disclosure. Although embodiments of the present disclosure may be described with specific reference to medical devices and systems and procedures for treating the gastrointestinal system, it should be understood that such medical devices and methods may be used to treat tissues of the abdominal cavity, digestive system, urinary tract, reproductive tract, respiratory system, cardiovascular system, circulatory system, and the like.

[0065] The foregoing discussion has a wide range of applications and is presented for purposes of illustration and explanation, and is not intended to limit the present disclosure to the forms disclosed herein. It will be understood that various additions, modifications, and substitutions may be made to the embodiments disclosed herein without departing from the concept, spirit, and scope of the present disclosure. In particular, it will be apparent to those skilled in the art that the principles of the present disclosure may be embodied in other forms, structures, arrangements, ratios, and with other elements, materials, and components without departing from the concept, spirit, or scope, or characteristics thereof. For example, various features of the present disclosure are grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the present disclosure. However, it should be understood that various features of a particular aspect, embodiment, or configuration of the present disclosure may be combined in alternative aspects, embodiments, or configurations. Although the present disclosure is presented with respect to embodiments, it should be understood that the various separate features of the subject matter of the present application need not all be present to achieve at least some of the desired properties and / or advantages of the subject matter of the present application or such individual features. Those skilled in the art will appreciate that the present disclosure may be used with many variations or modifications of the structure, arrangement, proportions, materials, components, and the like used in the practice of the present disclosure to specifically adapt to a particular environment and operational requirements without departing from the principles or spirit or scope of the present disclosure. For example, elements shown as integrally formed may be comprised of multiple pieces, elements shown as multiple pieces may be integrally formed, operations of elements may be reversed or otherwise varied, and elements may be changed in size or dimensions. Similarly, although operations or actions or steps are described in a particular order, this should not be construed as requiring such a particular order to achieve desired results, or that all operations or actions or steps should be performed. Additionally, other implementations are within the scope of the following claims. In some cases, the actions recited in the claims may be performed in a different order and still achieve desirable results.Accordingly, the embodiments disclosed herein should be considered in all respects as illustrative and not restrictive, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the foregoing description or the specific embodiments or configurations described or illustrated herein. In view of the above, individual features of any embodiment can be used and claimed separately or in combination with the features of that or any other embodiment, and the scope of the subject matter is indicated by the appended claims and is not limited to the foregoing description.

[0066] In the foregoing description and in the claims that follow, it will be understood that the terms "at least one," "one or more," and "and / or," as used herein, are open-ended expressions that are both conjunctive and disjunctive in operation. Terms such as "a," "an," "the," "first," "second," etc. do not preclude a plurality. For example, the term "a" or "an" entity, as used herein, refers to one or more of that entity. Thus, the terms "a" (or "an"), "one or more," and "at least one" can be used interchangeably herein. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, up, down, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or the like) are used solely for identification purposes to aid in the reader's understanding of this disclosure and / or serve to distinguish regions of associated elements from one another, and are not intended to limit the associated elements with respect to position, orientation, or use of this disclosure in particular. Connection references (e.g., attached, coupled, connected, engaged, and joined) should be interpreted broadly and may include intermediate members between and relative movement between elements of a collection of elements, unless otherwise indicated. Thus, connection references do not necessarily mean that two elements are directly connected and in a fixed relationship to one another. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority, but are used to distinguish one feature from another.

[0067] The following claims are incorporated into this detailed description by this reference, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the term "comprises / comprising" does not exclude the presence of other elements, components, features, regions, integers, steps, operations, etc. In addition, although individual features may be included in different claims, which may in some cases be advantageously combined, the inclusion in different claims does not imply that a combination of features is not feasible and / or advantageous. In addition, a reference to the singular does not exclude a plurality. Reference signs in the claims are provided merely as a clarifying example and should not be construed as limiting the scope of the claims in any way.

Claims

1. A tissue retraction device a circumferential section defining a periphery of the tissue retraction device; and at least one gripping segment engageable with tissue; at least one additional gripping segment extending within the perimeter section and engageable with tissue; Equipped with A tissue retraction device, wherein the gripping segment defines one target tissue engaging segment engageable with a target tissue, a first traction tissue engaging segment engageable with traction tissue spaced from the target tissue and applying a traction force to the target tissue, and a second traction tissue engaging segment engageable with traction tissue and changing the force vector of traction applied to the target tissue by the first traction tissue engaging segment.

2. The tissue retraction device of claim 1 , wherein a distance between the second retracting tissue engaging segment and the target tissue is less than a distance between the first retracting tissue engaging segment and the target tissue.

3. The tissue retraction device of claim 2 , wherein the first and second retracting tissue engaging segments engage the retracting tissue at the same location.

4. 3. The tissue retraction device of claim 2, wherein the first traction tissue engaging segment engages the traction tissue at a first location and the second traction tissue engaging segment engages the traction tissue at a second location spaced from the first location.

5. 2. The tissue retraction device of claim 1, wherein the first traction tissue engaging segment engages the traction tissue at a first location and the second traction tissue engaging segment engages the traction tissue at a second location spaced from the first location to change a force vector of traction applied to the target tissue.

6. 6. The tissue retraction device of claim 1, wherein the first traction tissue engaging segment is defined along the circumferential section and the at least one further gripping segment defines the second traction tissue engaging segment within a perimeter of the circumferential section.

7. 7. The tissue retraction device of claim 1, wherein the circumferential section has an elliptical shape, the target tissue engaging segment is defined along a first focal point of the elliptical shaped circumferential section, the first traction tissue engaging segment is defined along a second focal point of the elliptical shaped circumferential section, and the gripping segment defining the second traction tissue engaging segment is a loop extending about the first focal point of the elliptical shaped circumferential section.

8. The tissue retraction device of any one of claims 1 to 7, wherein the at least one additional gripping segment includes a first loop defining a first gripping segment and a second loop defining a second gripping segment within a perimeter of the outer circumferential section.

9. The tissue retraction device of any one of claims 1 to 8, wherein at least one of the additional gripping segments extends transversely to the direction in which the tissue retraction device extends between the target tissue and the retracting tissue.

10. The tissue traction device of any one of claims 1 to 9, wherein at least one of the gripping segments defined along a periphery of the circumferential section or the at least one further gripping segment extending within the periphery of the circumferential section has a different thickness than another gripping segment of the tissue traction device.

11. The tissue retraction device of any one of claims 1 to 10, wherein the tissue retraction device is formed from an elastic material.

12. 1. A delivery system for a tissue retraction system, the delivery system comprising: a tissue retraction device defining a peripheral section in the form of a loop defining at least one target tissue engaging segment and at least one retracting tissue engaging segment spaced from the target tissue engaging segment; a tissue retraction device holder engageable with the tissue retraction device to maintain the target tissue engaging segment spaced apart from the retracting tissue engaging segment; A delivery system comprising:

13. The delivery system of claim 12 , wherein the tissue retraction device further comprises at least one additional gripping segment defined along or extending within a perimeter defined by the circumferential section.

14. The delivery system of any one of claims 12 to 13, wherein the tissue retraction system further comprises a tissue engaging member engaged with the target tissue engaging segment of the tissue retraction device.

15. 15. The delivery system of claim 14, further comprising a tissue engaging member delivery device extending into the tissue retraction device holder to maintain the tissue engaging member and the target tissue engaging segment of the tissue retraction device engaged therewith spaced apart from a portion of the tissue retraction device engaged with the tissue retraction device holder.

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