Tissue retraction devices and systems

Abstract

A tissue retraction device having a pair of legs biased toward each other by a biasing portion. The legs can be biased away from each other and engaged with a tissue site so as to be separated from each other when the legs are biased away from each other. Alternatively, the legs can be biased toward each other, with one leg engaged with cut tissue relative to the treatment site and the other leg engaged with anchoring tissue away from the treatment site. The legs can be biased toward each other to draw the cut tissue relative to the treatment site away from the treatment site and toward the anchoring tissue. The tissue retraction device can be included in a tissue retraction system having a delivery shaft configured to deliver the tissue retraction device to the treatment site.

Description

[Technical Field]

[0001] The present disclosure relates generally to the field of devices, systems, and methods for applying traction to tissue. More particularly, the present disclosure relates to retraction devices and systems and the use of such devices and systems to move tissue away from a treatment site. [Background technology]

[0002] Various endoscopic surgical procedures require manipulation around various anatomical structures. Several procedures, such as endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), and peroral endoscopic myotomy (POEM), allow for minimally invasive endoscopic removal of benign and early-stage malignant lesions, such as those in the gastrointestinal (GI) tract. Minimally invasive surgical techniques such as these typically allow for faster recovery than open or laparoscopic surgical procedures. However, due to their minimally invasive nature, such procedures have limited space for maneuvering within the body, and they typically require a high level of expertise. In procedures involving tissue cutting, one of the greatest factors in time and complexity is the management of the tissue being cut. Separated pieces of tissue can obstruct visibility, such as falling onto the endoscope and blocking the camera's view, affect the movement of instruments used during the procedure, and prevent access to all areas and depths of the tissue being cut at the treatment site. Various solutions have been developed for lifting cut (and often sagging) tissue masses, thereby clearing a path for the visibility and manipulation of medical tools and devices. However, placement of elements used with such solutions can be difficult, especially in space-restricted environments. Also, elements used with such solutions may require medical tools separate from those used to perform the procedure, and such tools may even require separate working channels within the endoscope, thereby potentially increasing the size and / or complexity of the endoscope. Alternative solutions for lifting tissue during procedures that reduce the cost, complexity, and cognitive load presented by currently available solutions would be welcome. Summary of the Invention

[0003] This Summary of the disclosure is provided to aid in understanding, and 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 instances or in combination with other aspects and features of the disclosure in other instances. No limitation as to the scope of the claimed subject matter is intended by the inclusion or non-inclusion of elements, components, etc. in this Summary.

[0004] According to various principles of the present disclosure, a tissue retraction system includes a pair of legs biased toward one another by a biasing portion and a delivery shaft defining a lumen through which the tissue retraction device can be delivered to a treatment site. In some aspects, the tissue retraction device is transitionable between a delivery configuration and a deployed configuration, the legs of the tissue retraction device include tissue engaging tips configured to engage tissue, the delivery shaft is configured to maintain the tissue retraction device in the delivery configuration, and in the deployed configuration, the biasing portion of the tissue retraction device exerts a traction force on the tissue through the legs of the tissue retraction device to pull the tissue away from the treatment site.

[0005] In some embodiments, the biasing portion connects the legs of the tissue retraction device. In some embodiments, the biasing portion biases the legs of the tissue retraction device away from each other to lift the tissue away from the treatment site.

[0006] In some embodiments, the biasing portion biases the legs of the tissue retraction device toward each other to lift the tissue away from the treatment site and toward the anchoring tissue spaced from the treatment site.

[0007] In some embodiments, at least one of the tissue engaging tips extends from one of the legs laterally relative to that one of the legs and in the direction in which the biasing portion biases that one of the legs. In some embodiments, at least one of the tissue engaging tips extends from a free end of one of the legs. In some embodiments, the biasing portion biases the legs of the tissue retraction device away from each other, and a tissue engaging tip extends from the free end of each of the legs in a direction away from the other of the legs. In some embodiments, the biasing portion biases the legs of the tissue retraction device toward each other.

[0008] In some embodiments, the tissue engaging tip of the tissue retraction device is disposed within a seat defined in the delivery shaft. In some embodiments, the tissue retraction system includes a pusher configured to push the tissue retraction device out of the delivery shaft, hi some embodiments, the pusher is detachably coupled to the tissue retraction device.

[0009] In some embodiments, the tissue retraction system includes a plurality of tissue retraction devices maintained in a delivery configuration within a lumen of a delivery shaft for delivery to a treatment site. In some embodiments, the tissue retraction system includes an endoscope having a working channel, and the delivery shaft is configured for delivery to the treatment site through the working channel of the endoscope.

[0010] According to various principles of the present disclosure, a tissue retraction device includes a pair of legs biased toward each other by a biasing portion, the tissue retraction device being transitionable between a delivery configuration in which the tissue retraction device is deliverable through a lumen of a delivery shaft and a deployed configuration in which the biasing portion of the tissue retraction device exerts a traction force on the tissue to pull the tissue away from a treatment site, at least one of the legs of the tissue retraction device including a tissue engaging tip configured to engage tissue, the tissue engaging tip extending from a free end of at least one of the legs in a direction transverse to at least one of the legs.

[0011] In some embodiments, the biasing portion biases the legs of the tissue retraction device away from one another, and the tissue engaging tip extends from a free end of at least one of the legs of the tissue retraction device in a direction away from the other of the legs of the tissue retraction device.

[0012] In some embodiments, the biasing portion biases the legs of the tissue retraction device toward each other, and the tissue engaging tip extends from a free end of at least one of the legs of the tissue retraction device in a direction toward the other of the legs of the tissue retraction device.

[0013] In accordance with various principles of the present disclosure, a method of applying traction to tissue to pull the tissue away from a treatment site to allow unobstructed access to the treatment site includes delivering to the treatment site a tissue retraction device having a pair of legs biased toward each other by a biasing portion, engaging a tissue engaging portion extending from one of the pair of legs of the tissue retraction device with tissue to be pulled away from the treatment site, engaging a tissue engaging portion extending from the other of the pair of legs with tissue other than the tissue to be pulled away from the treatment site, and exerting a biasing force from the biasing portion on the legs of the tissue retraction device to apply traction to the tissue to be pulled away from the treatment site.

[0014] In some aspects, the method includes engaging the other tissue engaging portion of the pair of legs with tissue at the treatment site and cutting against the tissue being pulled away from the treatment site, and applying a biasing force includes spreading the legs away from each other via the biasing portion.

[0015] In some aspects, the method includes engaging the other tissue engaging portion of the pair of legs with tissue away from the treatment site, and applying a biasing force includes drawing the legs toward each other via a biasing portion.

[0016] In some embodiments, engaging at least one tissue engaging portion of the legs with tissue includes engaging the tissue engaging portion with tissue in a direction in which the biasing portion exerts a biasing force on the leg from which the tissue engaging portion extends.

[0017] 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. While 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 or any other embodiment. [Brief explanation of the drawings]

[0018] 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 figures within the drawings may vary. For example, a device may be enlarged so that details can be discerned, but is intended to be reduced in size to fit within the working channel of, for example, a delivery catheter or endoscope. It should be noted that in the various figures, identical, substantially identical, or equivalent elements may be labeled with the same reference numeral, and similar elements may be labeled with similar reference numerals that differ by 100, without redundant description. For clarity and conciseness, not every element is labeled in every figure, and not every element of each embodiment is shown unless illustration is necessary to enable those skilled in the art to understand the present disclosure. The detailed description will be better understood in conjunction with the accompanying drawings, as follows, in which like reference numerals represent like elements. [Figure 1A] FIG. 1A is a perspective view of an example embodiment of a tissue retraction system according to various principles of the present disclosure, with a portion of its delivery shaft shown in cross section to illustrate an example embodiment of a tissue retraction device therein. [Figure 1B]FIG. 1B is a perspective view similar to FIG. 1A, but with the tissue retraction device advanced to engage tissue. [Figure 1C] FIG. 1C shows a system similar to that shown in FIGS. 1A and 1B being withdrawn from the treatment site, leaving behind a tissue retraction device that applies traction to tissue at the treatment site. [Figure 2] FIG. 2 is an enlarged, isolated cross-sectional view of the distal end of an example embodiment of a delivery shaft of a tissue retraction system formed in accordance with various principles of the present disclosure, with an example embodiment of a tissue retraction device engaged therein. [Figure 3] FIG. 3 is a perspective view of the distal end of an example embodiment of a delivery shaft of a tissue retraction system as shown in FIG. 2, with an example embodiment of a tissue retraction device disposed therein. [Figure 4] FIG. 4 is a perspective view of the distal end of one example of an embodiment of a delivery shaft of a tissue retraction system as shown in FIG. 2, but without the tissue retraction device. [Figure 5] FIG. 5 illustrates an example embodiment of a tissue retraction device formed in accordance with various principles of the present disclosure. [Figure 6] FIG. 6 illustrates an example embodiment of a tissue retraction device formed in accordance with various principles of the present disclosure. [Figure 7] FIG. 7 illustrates an example embodiment of a tissue retraction device formed in accordance with various principles of the present disclosure. [Figure 8] FIG. 8 illustrates an example embodiment of a tissue retraction device formed in accordance with various principles of the present disclosure. [Figure 9A] 9A-9F illustrate various stages of use of tissue retraction devices and systems according to various principles of the present disclosure. [Figure 9B] 9A-9F illustrate various stages of use of tissue retraction devices and systems according to various principles of the present disclosure. [Figure 9C] 9A-9F illustrate various stages of use of tissue retraction devices and systems according to various principles of the present disclosure. [Figure 9D]9A-9F illustrate various stages of use of tissue retraction devices and systems according to various principles of the present disclosure. [Figure 9E] 9A-9F illustrate various stages of use of tissue retraction devices and systems according to various principles of the present disclosure. [Figure 9F] 9A-9F illustrate various stages of use of tissue retraction devices and systems according to various principles of the present disclosure. [Figure 10A] 10A-10D show an example embodiment of a tissue retraction device and system and its use at various stages of deployment. [Figure 10B] 10A-10D show an example embodiment of a tissue retraction device and system and its use at various stages of deployment. [Figure 10C] 10A-10D show an example embodiment of a tissue retraction device and system and its use at various stages of deployment. [Figure 10D] 10A-10D show an example embodiment of a tissue retraction device and system and its use at various stages of deployment. [Figure 11A] FIG. 11A illustrates another example embodiment of a tissue retraction device formed in accordance with various principles of the present disclosure. [Figure 11B] FIG. 11B shows a tissue retraction device as shown in FIG. 11A, but in a different configuration. [Figure 12A] 12A-12D illustrate various stages of use of a tissue retraction device and system such as shown in FIGS. 11A and 11B, according to various principles of the present disclosure. [Figure 12B] 12A-12D illustrate various stages of use of a tissue retraction device and system such as shown in FIGS. 11A and 11B, according to various principles of the present disclosure. [Figure 12C] 12A-12D illustrate various stages of use of a tissue retraction device and system such as shown in FIGS. 11A and 11B, according to various principles of the present disclosure. [Figure 12D]12A-12D illustrate various stages of use of a tissue retraction device and system such as shown in FIGS. 11A and 11B, according to various principles of the present disclosure. [Figure 13] FIG. 13 illustrates another example embodiment of a tissue retraction system according to various principles of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0019] The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. It should be understood that the present disclosure is not limited to the particular embodiments described, and as such may vary. All devices, systems, and methods described herein are examples of devices and / or systems and / or methods implemented in accordance with one or more principles of the present disclosure. Each example embodiment is provided for illustrative purposes and is merely an example, not the only way, to implement these principles. Therefore, references to elements or structures or features in the drawings should be recognized as references to example embodiments of the present disclosure and should not be understood as limiting the disclosure to the particular elements, structures, or features illustrated. 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 present subject matter. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield a still further embodiment. Accordingly, the present subject matter is intended to cover all such modifications and variations that come within the scope of the appended claims and their equivalents.

[0020] It will be understood that the present disclosure is described in this application with varying levels of detail. In certain instances, details not necessary for those skilled in the art to understand the present disclosure or that would make it difficult for those skilled in the art to appreciate other details may be omitted. The terminology used herein is for the purpose of describing particular embodiments only and is 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.

[0021] As used herein, "proximal" refers to a direction or location closest to a user (e.g., a medical professional or clinician or technician or operator or physician, etc., such terms are used interchangeably herein without limitation and include an automated controller system, etc.) and / or closest to a delivery device, such as when using the device (e.g., when introducing the device into a patient or during implantation, placement, or delivery), and "distal" refers to a direction or location furthest from a user and / or closest to a delivery device, such as when using the device (e.g., when introducing the device into a patient or during implantation, placement, or delivery). "Longitudinal" means extending along the longer or greater dimension of an element. A "longitudinal axis" extends along the longitudinal extent of an element, but is not necessarily straight, and does not necessarily maintain a fixed configuration when the element flexes or bends. "Center" means at least generally intersecting the center point and / or generally equidistant from the periphery or boundary, and "central axis," with respect to an opening, means a line that at least generally intersects the center point of the opening and extends longitudinally along the length of the opening, where the opening comprises, for example, a tubular element, post, channel, cavity, or hole. As used herein, a "free end" of an element is a terminus beyond which such element does not extend.

[0022] In accordance with various principles of the present disclosure, tissue retraction systems and tissue retraction devices are configured and designed to apply traction to tissue at a treatment site. It will be understood that terms such as traction, tension, retraction, separation, and pulling may be used interchangeably herein, including other grammatical forms, without any intended limitation. Furthermore, it will be understood that a treatment site may alternatively be referred to herein, without any intended limitation, as an anatomical site, a target site, a retraction site, a resection site, an incision site, and the like. In some embodiments, a tissue retraction device formed in accordance with various principles of the present disclosure is deployed to separate a segment of tissue from adjacent and / or surrounding tissue. In some embodiments, tissue at the treatment site is cut, and a tissue retraction device is placed against the cut tissue to separate (e.g., spread apart) the cut edges of the tissue. A tissue retraction device formed in accordance with various principles of the present disclosure can then be used to lift a portion of the tissue from the treatment site, allowing further treatment, such as tissue dissection or tissue resection, to be performed at the treatment site. For example, endoscopic submucosal dissection can be more easily performed using a tissue retraction device that lifts mucosal tissue from the submucosa to facilitate manipulation (e.g., dissection) of the submucosal tissue. For convenience, and without any limitation, a separated segment of tissue may be referred to herein as a tissue flap. Unless otherwise specified, it will be understood that references "at" a treatment site are intended to include tissue at and near the treatment site (e.g., along, adjacent, etc.) and are not limited to tissue located exactly at the site being treated. It will be understood that terms such as engage (and other grammatical forms) may be used interchangeably herein with terms such as join, grasp, hold, fasten, clip, secure, attach, affix, fasten, etc. (and other grammatical forms) without any limitation. It will be understood that terms such as portion, area, section, segment, etc. may be used interchangeably herein without any limitation.

[0023] In some embodiments, the tissue retraction device includes a first leg and a second leg connected by a biasing portion of the tissue retraction device. The biasing portion can bias the legs toward or away from each other depending on the intended deployment of the tissue retraction device, and the direction of the biasing can be selected. For example, in some embodiments, a first leg of the tissue retraction device can be engaged with tissue at the treatment site, and a second leg of the tissue retraction device can be engaged with tissue separated from the treatment site (e.g., severed relative to the treatment site), and the biasing portion biases the first leg and the second leg away from each other. In response to deployment of such an embodiment, the legs move the tissue separated from the treatment site away from the tissue at the treatment site, facilitating access to the treatment site. Thus, the tissue separated from the treatment site can form a flap that is moved (e.g., lifted) away from the treatment site by the second leg of the tissue retraction device, while the first leg engages with tissue at or adjacent to the treatment site. In other embodiments, a first leg of the tissue retraction device may be engaged with cut tissue relative to the treatment site (e.g., creating a tissue flap), and a second leg of the tissue retraction device may be engaged with tissue away from the treatment site (e.g., distal to the treatment site), with the biasing member biasing the first and second legs together. Upon deployment of such an embodiment, the legs move the tissue separated from the treatment site away from the treatment site and toward the tissue spaced from the treatment site to facilitate access to the treatment site.

[0024] The legs of a tissue retraction device formed according to various principles of the present disclosure are coupled together via a biasing portion and have free ends extending away from the coupled ends. The free ends of the legs of the tissue retraction device can have tissue-engaging tips. For example, in some embodiments, the tissue-engaging tips are thin, sharp, pointed, or otherwise configured to penetrate tissue. In some embodiments, the tissue-engaging tips extend transversely relative to the extent of the legs, from the biasing portion to their free ends to the tissue-engaging tips. The tissue-engaging tips can extend in a direction relative to the extent of the legs of the tissue retraction device to facilitate engagement with and apply traction to the tissue. For example, the direction in which the tissue-engaging tips extend relative to the legs of the tissue retraction device can be based on the bias of the legs and / or the manner in which the tissue retraction device applies traction to the tissue (e.g., separating two areas of tissue, such as a cut portion of tissue, from tissue at a treatment site, or pulling a cut area of tissue away from the treatment site and toward tissue spaced from the treatment site).

[0025] A tissue retraction system may include a delivery shaft capable of delivering one or more tissue retraction devices formed according to various principles of the present disclosure to a treatment site. The system may include one or more of a pusher (e.g., for deploying one or more tissue retraction devices from the delivery shaft), a treatment tool (e.g., for performing a treatment on the treatment site), an end effector (e.g., for manipulating tissue or components of the tissue retraction system, including, but not limited to, a tissue retraction device), a tissue closure device and / or system (e.g., for closing severed tissue at the treatment site), and other additional devices and systems as would be understood by one skilled in the art to be useful in a tissue retraction system formed according to various principles of the present disclosure.

[0026] Various embodiments of tissue retraction devices, systems, and methods are described below with reference to examples shown in the accompanying drawings. References herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., indicate that one or more particular features, structures, concepts, and / or characteristics according to the principles of the present disclosure may be included in connection with the embodiment. However, such references do not necessarily imply that all embodiments include the particular feature, structure, concept, and / or characteristic, or that one embodiment includes all features, structures, concepts, and / or characteristics. Some embodiments may include one or more such features, structures, concepts, and / or characteristics in various combinations thereof. It should be understood that one or more of the features, structures, concepts, and / or characteristics described with reference to one embodiment may be combined with one or more of the features, structures, concepts, and / or characteristics of any of the other embodiments provided herein. That is, any of the features, structures, concepts, and / or characteristics described herein can be mixed and matched to create hybrid embodiments, and such hybrid embodiments are within the scope of the present disclosure. Furthermore, references in various places herein to “one embodiment,” “an embodiment,” “some embodiments,” “other embodiments,” etc., do not necessarily all refer to the same embodiment, and separate or alternative embodiments are not necessarily mutually exclusive of other embodiments. Furthermore, it is to be understood that various features, structures, concepts, and / or properties of the disclosed embodiments are independent and distinct from one another and may be used or exist individually or in various combinations with one another to create alternative embodiments that are considered part of this disclosure. Accordingly, the present disclosure is not limited to only the embodiments specifically described herein. It would be unduly tedious to describe all of the many possible combinations and subcombinations of features, structures, concepts, and / or properties, and the example embodiments disclosed herein are not intended to limit the broader aspects of the present disclosure. The following description is merely an illustrative example of an embodiment and is not intended to limit the broader aspects of the present disclosure.

[0027] In the accompanying drawings illustrating examples of embodiments of tissue retraction devices and systems, it should 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 generally will not be repeated. For clarity, not all components having the same reference number are numbered. Furthermore, groups of similar elements may be indicated by numbers and letters, and generally, one or such elements, or such elements as a group, may be referred to by the number alone (without including the letter associated with each similar element). In the following description, it will be understood that similar elements or components among the various illustrated embodiments having a reference number greater than 100 will generally be designated by the same reference number increased by a multiple of 100, and redundant descriptions will generally be omitted for brevity. Furthermore, specific features in one embodiment may be used across different embodiments and will not necessarily be individually labeled when appearing in different embodiments.

[0028] Referring now to the drawings, an example embodiment of a tissue retraction system 100 is shown in FIGS. 1A-1C at various stages of delivery and deployment of a tissue retraction device 110. The tissue retraction device 110 may, in some aspects, be considered part of the tissue retraction system 100. The tissue retraction system 100 includes a delivery shaft 120 defining a lumen 122 through which the tissue retraction device 110 can be delivered to a treatment site TS, as shown in FIG. 1A. A pusher 130 movably extends through the lumen 122 of the delivery shaft 120 and, upon reaching the treatment site TS, can push the tissue retraction device 110 distally from the delivery shaft 120. In the illustrated example embodiment, the pusher 130 has a distal end 131 that abuts the proximal end 113 of the tissue retraction device 110. Optionally, pusher 130 has a wider (in a direction transverse to longitudinal axis LA of tissue retraction system 100) or enlarged distal portion 132 configured to abut proximal end 113 of tissue retraction device 110. Alternatively, as described in further detail below, pusher 130 may be reversibly coupled (e.g., detachably coupled) to tissue retraction device 110.

[0029] The tissue retraction device 110 includes at least two legs 112 coupled together by / along a biasing portion 114. The legs 112 can be separately formed and coupled to a separately formed biasing portion 114 to form an integrated tissue retraction device 110, or the tissue retraction device 110 may be formed from a unitary structure, such as a wire or other elongated, bendable, elastic material, that is bent into a desired shape / configuration. One or more sections of the tissue retraction device 110 may be formed from a shape-memory material and / or a thermoformable material, such as a nickel-titanium alloy (e.g., nitinol). At least the biasing portion 114 of the tissue retraction device 110 is elastically biased to bias the legs 112 of the tissue retraction device 110 in a desired direction (depending on the end use of the tissue retraction device 110, as described in further detail below).

[0030] 1A-1C, the tissue retraction device 110 is delivered to the treatment site TS within the delivery shaft 120 in a constrained configuration that must hold the legs 112 together against the biasing force of the biasing portion 114, which biases or drives the legs 112 apart. The legs 112 may alternatively be described as compressed, contracted, constrained, restricted, etc., without intending to be limiting.

[0031] Once the tissue retraction system 100 is delivered to the treatment site TS, as shown in FIG. 1A , the pusher 130 can be advanced distally to advance the tissue retraction device 110 distally to engage tissue at the treatment site TS, as shown in FIG. 1B . The pusher 130 can be advanced by controlling its proximal end using a control handle, not shown, or the like, which can be of any configuration known to those skilled in the art, the configuration of which is not critical to and not limiting of the present disclosure. When the distal end 111 of the tissue retraction device 110 is advanced beyond the distal end 121 of the delivery shaft 120, the tissue engaging tip 116 of the tissue retraction device 110 can engage tissue at or along the treatment site TS, as shown in FIG. 1B . In the example embodiment shown in FIGS. 1A-1C , the tissue engaging tip 116 is formed along the free end 115 of the leg 112, although other positions and / or configurations are within the scope and spirit of the present disclosure. Additionally or alternatively, the tissue engaging tip 116 extends transversely relative to the portion of the leg 112 from which the tissue engaging tip 116 extends. For example, the tissue engaging tip 116 can extend transversely relative to the leg 112, such as transversely relative to the length of the leg 112 (defined generally along the direction in which the leg 112 extends from the biasing portion 114 toward the distal end 111 of the tissue retraction device 110 and / or along the longitudinal axis LA).

[0032] In some aspects, at least one of the tissue engaging tips 116 extends in generally the same direction as the biasing force applied to the legs 112 by the biasing portion 114. Such a configuration can facilitate engagement and / or penetration of the tissue engaging tip 116 with tissue. In other words, the tissue engaging tip 116 of one leg 112 of the tissue retraction device 110 can extend away from the other leg 112 when the legs 112 are biased away from each other by the biasing portion 114. In one example embodiment shown in FIGS. 1A-1C , the legs 112 of the tissue retraction device 110 are biased away by the biasing portion 114 of the tissue retraction device 110 to separate sections of tissue with which the tissue engaging tips 116 are respectively engaged. Thus, the tissue engaging tip 116 can extend outward from the longitudinal axis LA of the tissue retraction system 100 / tissue retraction device 110 when the tissue retraction device 110 is engaged with tissue, as shown in FIG. 1B.

[0033] As the tissue retraction device 110 is advanced distally out of the delivery shaft 120, the legs 112 are released from a constrained configuration within the lumen 122 of the delivery shaft 120 (as shown in FIGS. 1A and 1B ) and begin to apply traction to tissue at and along the treatment site TS. For example, as the distal end 111 of the tissue retraction device 110 is extended beyond the distal end 121 of the delivery shaft 120, the free ends 115 of the legs 112 transition to an unconstrained, spread, neutral, or traction-applying configuration (such terms are used interchangeably herein, without limitation), and the legs 112 move away from one another (e.g., move away from the longitudinal axis LA). When unconstrained, the legs 112 of the tissue retraction device 110 can exert a traction force on tissue sections engaged thereby (e.g., by their free ends 115). As shown in FIGS. 1B and 1C , one leg 112 of the tissue retraction device 110 is engaged with tissue (e.g., at its tissue-engaging tip 116) at the treatment site TS, and another leg 112 of the tissue retraction device 110 is engaged with tissue (e.g., at its tissue-engaging tip 116) that has been separated from the tissue at the treatment site TS by incision or cutting. When the legs 112 are unconstrained and allowed to spread apart (e.g., by being biased apart by a biasing member 114), the legs 112 apply traction to the tissue that has been cut relative to the treatment site TS. The tissue that has been cut relative to the treatment site TS can be considered to form a flap F that is lifted away from the treatment site TS by the leg 112 opposite the leg 112 that is engaged with the tissue at the treatment site TS, as shown in FIGS. 1B and 1C . It will be understood that the tissue that has been separated from the treatment site TS may be referred to herein as a flap F for convenience and without any intention of limitation. Once the tissue retraction device 110 is fully deployed, the delivery shaft 120 can be retracted and the tissue retraction device 110 can be left in place to remove the cut tissue (flap F) from the treatment site TS, as shown in FIG. 1C.As will be appreciated, lifting of the flap F relative to the treatment site TS by the extended tissue retraction device 110 allows additional procedures (such as endoscopic submucosal resection of tissue at the treatment site TS and / or tissue beneath the lifted tissue) to be performed at the treatment site TS without interference of the flap F. For example, procedures can be performed beneath the flap F without obstructing or interfering with access of such tissue to the treatment site TS, as might otherwise occur.

[0034] Optionally, tissue retraction system 100 is delivered through another delivery device or system, such as an endoscope 140. Delivery system 100 can be advanced distally through a working channel 142 of endoscope 140 to a treatment site TS to deploy tissue retraction device 110 (e.g., as shown in FIGS. 1A and 1B ). Once tissue retraction device 110 is deployed, delivery shaft 120 can be retracted or withdrawn proximally through working channel 142 of endoscope 140 (e.g., as shown in FIG. 1C ). Such advancement and retraction of delivery shaft 120 can be performed in a manner known to those skilled in the art, and therefore further details are not deemed necessary for a complete disclosure of the various principles of the present disclosure.

[0035] In some embodiments, the tissue retraction device 110 can be delivered substantially completely within the delivery shaft 120, such as with the distal end 111 of the tissue retraction device 110 residing within the delivery shaft 120 and proximal to the distal end 121 of the delivery shaft 120, as shown in FIG. 1A. However, in other embodiments, a portion of the distal end of the tissue retraction device may engage and / or extend outwardly from the delivery shaft during its delivery. For example, as illustrated in FIGS. 2-4, a distal portion 210 of the tissue retraction device 210, such as the tissue-engaging tips 216 of the legs 212 of the tissue retraction device 210, may be disposed within a seat 225 defined within a section of the distal end 221 of the delivery shaft 220. In some embodiments, a portion of the tissue retraction device 210 may extend outwardly (e.g., away from the longitudinal axis LA of the system / device) from the delivery shaft 220 during its delivery, as shown in FIGS. 2 and 3. The seat 225 may be formed within the lumen 222 of the delivery shaft 220 and may optionally extend through the wall of the delivery shaft 220 to form a slot as shown in FIG.

[0036] It will be understood that tissue retraction devices formed in accordance with the principles of the present disclosure can have any of a variety of configurations that enable their legs to exert a traction force on tissue sections. Various example configurations of tissue retraction devices formed in accordance with various principles of the present disclosure are shown in Figures 5-7. It will be understood that other configurations of tissue retraction devices may be formed in accordance with various principles of the present disclosure, and that the present disclosure is not limited by the illustrated example embodiments.

[0037] The example embodiment of the tissue retraction device 110 shown in FIG. 5 is similar to the example embodiment of the tissue retraction device 110 shown in FIGS. 1A-1C, and therefore, its features are designated with the same reference numerals, and reference is made to the above description of its various features. The tissue retraction device 110 shown in FIG. 5 can be used with the tissue retraction system 100 in the manner shown in FIGS. 1A-1C. In embodiments in which the tissue retraction device 110 is configured to separate tissue, such as for use as shown in FIGS. 1A-1C, the legs 112 of the tissue retraction device 110 shown in FIG. 5 can be considered to be shown in a constrained configuration generally crossing one another. The legs 112 are subjected to a biasing force exerted by a biasing member 114. When the legs 112 are unconstrained, the legs 112 (particularly their free ends 115) are biased apart by the biasing member 114 into an extended configuration, such as the configuration shown in FIG. 1C. The tissue engaging tips 116 of the legs 112 of the tissue retraction device 110 of FIG. 5 can extend outward from one another to engage tissue sections spaced apart by the unfolded tissue retraction device 110 .

[0038] The example embodiment of the tissue retraction device 210 shown in FIG. 6 is similar to the example embodiment of the tissue retraction device 110 shown in FIG. 5. However, in contrast to the example embodiment of the tissue retraction device 110 shown in FIG. 5, the free ends 215 of the legs 212 of the tissue retraction device 210 shown in FIG. 6 are spaced apart, or at least do not intersect with one another. In this manner, the tissue retraction device 210 may be considered similar to the example embodiment of the tissue retraction device 210 shown in FIGS. 2-4. Accordingly, features of the tissue retraction device 210 shown in FIG. 6 are designated with the same reference numerals as the tissue retraction device 210 shown in FIGS. 2-4, and reference is made to the above description of the various features thereof. It will be understood that when the tissue retraction device 210 is configured to separate tissue, the tissue retraction device 210 may be considered to be shown in FIG. 6 in a constrained configuration. Nevertheless, the biasing portion 214 exerts sufficient force on the legs 212 to further bias the legs 212 apart into the spread configuration shown in FIG. 1C.

[0039] The example embodiment of tissue retraction device 310 shown in Figure 7 is similar to the example embodiment of tissue retraction device 210 shown in Figure 6 in that the legs 312 are uncrossed and / or their free ends 315 may be spaced apart. However, the biasing portion 314 of the tissue retraction device 310 shown in Figure 7 is coiled to provide an increased biasing force to the legs 312 of the tissue retraction device 310. When the tissue retraction device 310 is configured to separate tissue, the tissue retraction device 310 may be considered to be shown in a constrained configuration, with the biasing portion 314 biasing the legs 312 apart into the spread configuration shown in Figure 1C.

[0040] Like the example embodiment of tissue retraction device 110 shown in Figure 5, the legs 412 of the example embodiment of tissue retraction device 410 shown in Figure 8 cross over one another. However, when the tissue retraction device 410 is configured to separate tissue, instead of the biasing member 414 biasing the legs 412 apart into an uncrossed configuration (as with the tissue retraction device 110 of Figure 5, as in the example embodiment of its use shown in Figures 1B and 1C), the biasing member 414 biases the legs 412 into a more crossed configuration (compared to the configuration shown in Figure 8), as shown in Figures 9C-9F (discussed in more detail below). It should be understood that when the tissue retraction device 410 is configured to separate tissue, the tissue retraction device 410 may be considered to be shown in a constrained configuration in Figure 8. Furthermore, it will be appreciated that in embodiments in which the tissue retraction device 410 is configured to separate tissue, the tissue engaging tip 416 may extend in a direction opposite to that of the tissue engaging tip 116 of the tissue retraction device 110 shown in Figure 5, such that when the tissue retraction device 410 is expanded to the traction-applying configuration, the tissue engaging tip 416 extends into the tissue section to be separated. Various other orientations of the tissue engaging tip are within the scope and spirit of the present disclosure.

[0041] An example of an embodiment using the tissue retraction system 100, 200 and / or tissue retraction device 110, 210, 310, 410 described above is shown in FIGS. 9A-9F. As shown in FIG. 9A, an incision I is made along a treatment site TS where a procedure is to be performed. While the incision I is shown to surround the treatment site TS, it may be more limited than shown (e.g., a small incision may be made around the entire treatment site TS, or there may be no incision at all). It should be understood that the incision I may be made in any desired manner known to those skilled in the art, and the present disclosure is not limited in this regard. The incision I defines / separates the treatment site TS from the tissue to be separated therefrom, hereinafter referred to for convenience and without limitation as a flap F.

[0042] To facilitate access to the treatment site TS, the tissue retraction system 100 is delivered to the treatment site TS, as shown in FIGURE 9B. A tissue retraction device 410, as shown in FIGURE 8, is shown extending from the distal end 121 of the delivery shaft 120, with the tissue engaging tips 416 of each leg 412 engaging the treatment site TS and the flap F, respectively. It should be understood that any of the other tissue retraction devices 110, 210, 310, or other configurations of tissue retraction devices formed in accordance with various principles of the present disclosure, may be used instead, and that the tissue retraction device 410 is illustrated for convenience and without intent to be limiting.

[0043] As shown in FIG. 9C , when the tissue retraction device 410 is delivered (fully extended outside the delivery shaft 120 shown in FIG. 8B ), the legs 412 are urged apart by the biasing portion 414, separating the flap F from the treatment site TS and allowing access to the treatment site TS and / or tissue beneath the flap F. Additional tissue retraction devices, such as the tissue retraction device 410 or other tissue retraction devices formed according to various principles of the present disclosure, may be used to apply further traction to the flap F to separate it from the treatment site TS, as shown in FIG. 9D .

[0044] Once the flap F is sufficiently distant from the treatment site TS, a treatment tool 150 (e.g., a cutting device such as a blade, a cautery, an irrigation device, a suction device, a needle for delivery of one or more injectable treatment materials, etc.) can be delivered (e.g., by use of the endoscope 140) to perform a treatment at the treatment site TS, as shown in Figure 9E. As can be seen with reference to Figure 9F, the tissue retraction device 410 provides sufficient traction to the flap F to allow the medical professional unobstructed access of the treatment tool 150 to perform the desired treatment on the treatment site TS.

[0045] It will be understood that various changes can be made to the various components, aspects, or actions described above without departing from the spirit and scope of the present disclosure. For example, as previously described, the pusher 130 may be configured to abut against or be coupled to a tissue retraction device 110 formed in accordance with various principles of the present disclosure. An example embodiment of a pusher 230 configured to be detachably coupled to an example embodiment of a tissue retraction device 210, and its method of use, is shown in FIGS. 10A-10D. It will be understood that a tissue retraction device 210 as shown in FIG. 6 and a delivery shaft 220 as shown in FIGS. 2-4 are shown in the example embodiment shown in FIGS. 10A-10D. However, other tissue retraction devices and delivery shafts as described herein or formed in accordance with various principles of the present disclosure may be used instead.

[0046] 10A , the pusher 230 is coupled to the tissue retraction device 210 via a detachable distal section 232. In the illustrated example embodiment, the detachable distal section 232 is coupled to the biasing portion 214 of the tissue retraction device 210. However, the detachable distal section 232 may instead be coupled to other sections / portions of the tissue retraction device 210. The detachable distal section 232 may be looped, hooked, or welded to (e.g., around) a portion of the tissue retraction device 210 in any desired and suitable manner, as will be understood by one skilled in the art, to allow the pusher 230 to advance the tissue retraction device 210 as desired and to allow detachment therefrom, as described below. For example, the detachable distal section 232 may be separated from the tissue retraction device 210, such as by being detached (e.g., broken) from the tissue retraction device 210. Additionally or alternatively, deformation of the detachable distal section 232 allows for release of the detachable distal section 232 from the tissue retraction device 210 .

[0047] 10A , once the tissue engaging tip 216 of the tissue retraction device 210 is engaged with tissue at the treatment site TS, one or both of the delivery shaft 220 and the pusher 230 can be moved to separate the pusher 230 from the tissue retraction device 210, as shown in FIG. 10C . For example, the delivery shaft 220 can be advanced distally toward the tissue retraction device 210 and push the tissue retraction device 210 away from the pusher 230, such as to disconnect the pusher 230 from the tissue retraction device 210. Additionally or alternatively, the pusher 230 can be pulled proximally to retract it away from the tissue retraction device 210 and disconnect it therefrom. The movement of the tissue retraction device 210 away from the pusher 230, such as in the direction of the arrow shown in FIG. 10C , applies tension to the pusher 230, particularly with respect to the frangible section immediately proximal to the detachable distal section 232. Once sufficient tension is applied, the detachable distal section 232 of the pusher 230 separates (eg, breaks) from its proximal portion of the pusher 230, and the tissue retraction device 210 is deployed, as shown in FIG. 10D.

[0048] It should be understood that other configurations of the detachable section of the pusher are within the scope and spirit of the present disclosure. For example, the detachable distal section of the pusher can be configured to extend through an opening through the tissue retraction device, e.g., through a biasing portion of the tissue retraction device. The detachable distal section can have a geometry that is selectively transitionable between an engaged configuration and a disengaged configuration relative to the tissue retraction device. For example, the detachable distal section and the tissue retraction device can have a lock-and-key arrangement, as known to those skilled in the art. For example, the detachable distal section of the pusher can be movable relative to the tissue retraction device so as to be insertable into an opening in a portion of the tissue retraction device. The detachable distal section of the pusher can be moved relative to the tissue retraction device to prevent relative movement therebetween. For example, the shape of the detachable distal section (e.g., a key) can be aligned with the shape of the opening (e.g., a keyhole) of the tissue retraction device, allowing the detachable distal section to pass through the opening of the tissue retraction device. The detachable distal section may then be advanced beyond the opening of the tissue retraction device and rotated out of alignment with the opening to prevent retraction of the pusher relative to the tissue retraction device. To deploy the tissue retraction device, the pusher may be rotated or otherwise moved / manipulated relative to the tissue retraction device so that the geometry of the detachable distal section of the pusher matches or is otherwise aligned with the opening of the tissue retraction device for withdrawal and detachment from the tissue retraction device. For example, the detachable distal section may be elongated, the opening of the tissue retraction device may be elongated, and the pusher may be rotatable to move its detachable distal section into alignment with the opening and pass distally therethrough. Once the detachable distal section of the pusher has moved beyond the opening of the tissue retraction device, the pusher may be moved or rotated to move the detachable distal section out of alignment with the opening, coupling, engaging, joining, etc., the pusher with the tissue retraction device.A wide variety of configurations embodying such concepts will be apparent to those skilled in the art, but for the sake of brevity they are not listed here or shown in the accompanying drawings.

[0049] Other variations on the tissue retraction devices, systems, and methods described above may relate to the direction of traction applied to tissue (such as tissue separated from a treatment site TS). Additionally or alternatively, other variations on the tissue retraction devices, systems, and methods described above may relate to the biasing force applied to the legs of a tissue retraction device formed according to various principles of the present disclosure. Additionally or alternatively, other variations on the tissue retraction devices, systems, and methods described above may relate to the manner in which the legs of the tissue retraction device engage the tissue. Various other modifications can be made without departing from the scope and spirit of the principles of the present disclosure.

[0050] For example, as described above, tissue retraction devices formed in accordance with various principles of the present disclosure may be configured such that their legs naturally assume a closed configuration when deployed. In such embodiments, instead of spreading apart and separating the tissue-engaging portions of the tissue retraction device, the tissue-engaging portions are biased toward or toward each other. Thus, the legs of such a tissue retraction device can draw tissue together, such as to draw tissue away from the treatment site TS toward the anchoring tissue site, thereby lifting the tissue away from the treatment site (e.g., creating and lifting a tissue flap). Various modifications to the tissue retraction devices described above can be made to form such embodiments. An example of an embodiment of a tissue retraction device 510 having legs 512 configured to draw tissue together is shown in FIGS. 11A and 11B.

[0051] The example embodiment of the tissue retraction device 510 illustrated in FIGS. 11A and 11B is similar to the tissue retraction devices 110 and 410 illustrated in FIGS. 5 and 8 and described above, in that its legs 512 cross each other. However, unlike the biasing portions 114 and 414 of the tissue retraction devices 110 and 410 (which bias the legs 112 and 412 apart), the biasing portion 514 of the tissue retraction device 510 illustrated in FIGS. 11A and 11B draws the legs 512 toward each other. Thus, the tissue retraction device 510 can be considered to be shown in a neutral or relaxed configuration in FIG. 11A and in a configuration that applies extended traction in FIG. 11B. More specifically, the legs 512 of the tissue retraction device 510 can be considered to be drawn away from each other in the direction of the arrows shown in FIG. 11B. 11B, the legs 512 of the tissue retraction device 510 exert a biasing force on the legs 512, pulling the legs 512 back to the configuration shown in FIG. 11A. Thus, the legs 512 can be coupled to different portions of tissue spaced apart from one another to draw such portions together. For example, the legs 512 can be coupled to cut tissue and anchoring tissue spaced from the cut tissue to move the cut tissue (e.g., as a tissue flap) away from the treatment site, thereby allowing treatment to be performed at the treatment site, such as beneath the cut tissue, without interference from the cut tissue.

[0052] 11A and 11B is that its tissue engaging tips 516 may be configured differently to accommodate different directions in which a biasing force or traction is applied by the biasing portion 514 to the legs 512 and / or by the legs 512 to tissue engaged by the tissue retraction device 510. For example, when the legs 512 are biased toward each other, the tissue engaging tips 516 may be positioned differently than the tissue engaging tips of the tissue retraction devices described above. For example, in the example embodiment illustrated in FIGS. 11A and 11B, the tissue engaging tip 516 of at least the leg 512 that engages the tissue flap (tissue separated from the treatment site) is oriented toward the other leg 512 when the tissue retraction device 510 is in the neutral configuration as shown in FIG. 11A. The other leg 512 of the tissue retraction device 510 may engage tissue, which may be considered anchoring tissue, against which the flap is pulled. The anchoring tissue engaging legs 512 may have tissue engaging tips 516 that extend away from the tissue flap engaged legs 512 as shown, or in some embodiments, extend toward the tissue flap engaged legs 512. It will be understood that the configuration of the tissue engaging tips 516 of a tissue retraction device 510 having legs 512 biased toward one another may be determined or configured based on the end use of the tissue retraction device 510.

[0053] An example of an embodiment using a tissue retraction device 510 such as that shown in FIGS. 11A and 11B is shown in FIGS. 12A-12D. As shown in FIG. 12A, an incision I is formed at a treatment site TS where a procedure is to be performed. The incision I may be formed in any desired manner known to those skilled in the art, and it should be understood that the present disclosure is not limited in this regard. The incision I defines / separates the treatment site TS from tissue to be separated therefrom, hereinafter referred to as a flap F for convenience and without intent to be limiting. To facilitate access to the treatment site TS, a tissue retraction system 100 is delivered to the treatment site TS as shown in FIG. 12A. The free ends 515 of the legs 512 of the tissue retraction device 510 as shown in FIGS. 11A and 11B are shown extending distally from the distal end 121 of the delivery shaft 120 so that the tissue-engaging tips 516 of each leg 512 can engage tissue.

[0054] 12B, the tissue engaging tip 516 of one of the legs 512 is engaged with tissue separated from the treatment site TS by an incision I. For convenience, and without any intent to be limiting, such tissue may be referred to herein as a flap F, and such a leg 512 may be referred to herein as a flap engaging leg 512. The tissue retraction system 100 may then be moved away from the treatment site TS, pulling the tissue retraction device 510 and the flap F away from the treatment site TS and allowing unobstructed access to the treatment site TS, such as for performing a procedure at the treatment site TS.

[0055] 12C , the other leg 515 of the tissue retraction device 510 can engage tissue spaced from the treatment site TS. Such tissue can serve to anchor the tissue retraction device 510 and exert a traction force on the flap F and, therefore, for convenience and without limitation, may be referred to herein as anchoring tissue AT. The legs 512 of the tissue retraction device 510 are biased together by the biasing member 514, so that when both legs 512 of the tissue retraction device 510 are engaged with tissue, the biasing member 514 draws the legs 512 together, pulling the flap F away from the treatment site TS and allowing access to the treatment site TS and / or tissue below the flap F. An additional tissue retraction device may be used to apply further traction to the flap F to separate it from the treatment site TS.

[0056] Once the flap F is sufficiently distant from the treatment site TS, a treatment tool 150 (such as those described above) can be delivered (e.g., by use of the endoscope 140) to perform a treatment at the treatment site TS, as shown in FIG. 12D. As will be appreciated, the tissue retraction device 510 provides sufficient traction to the flap F to allow the medical professional unobstructed access of the treatment tool 150 to perform the desired treatment on the treatment site TS.

[0057] In addition to variations in tissue retraction devices, variations in the tissue retraction systems described above can also be made without departing from the scope and spirit of the present disclosure. For example, a tissue retraction system 200, such as that shown in FIG. 13, can deliver two or more tissue retraction devices, such as tissue retraction device 110, formed according to various principles of the present disclosure. As shown in FIG. 13, two or more tissue retraction devices 110 can be loaded into the lumen 122 of the delivery shaft 120 of the illustrated tissue retraction system 200. For example, two or more tissue retraction devices 110 may be pre-loaded into the delivery shaft 120, arranged in series, end-to-end, stacked, or the like. In some embodiments, the tissue retraction devices 110 can push against each other to enable deployment. A pusher 130, as described above or in any other configuration known to one skilled in the art, may be used to push a tissue retraction device 110, such as the most proximal tissue retraction device 110, and push a more distal tissue retraction device 110 out of the delivery shaft 120.

[0058] It will be understood that the various principles of the present disclosure may be applied in other ways. For example, a system and / or device formed in accordance with the various principles of the present disclosure may be used for other applications, such as to keep a lumen dilated, or to keep a tunnel open in procedures such as G-POEM (gastrointestinal peroral endoscopic myotomy), or to maintain intramural or submucosal space, as needed, or other procedures that would benefit from one or more principles of the present disclosure.

[0059] It should be understood by those skilled in the art that this description is merely an illustration of example embodiments and is not intended as limiting the broader aspects of the present disclosure. All devices and methods described herein are examples of devices and / or methods implemented in accordance with one or more principles of the present disclosure. These examples are not the only ways of implementing these principles, but are merely examples and are not intended as limitations on the broader aspects of the present disclosure. Therefore, references to elements or structures or features in the drawings should be understood as references to example embodiments of the present disclosure and should not be understood as limiting the disclosure to the specific elements, structures, or features shown. Other examples of ways of implementing the disclosed principles will occur to those skilled in the art upon reading this disclosure.

[0060] It will be understood that various features described with respect to one embodiment may be applied to another embodiment, whether or not explicitly indicated. The various features described below may be used alone or in any combination thereof. Thus, the present invention is not limited to only the embodiments specifically described herein. Furthermore, it will be understood that various additional advantages of the various aspects, features, components, and structures of the tissue retraction devices and systems as described herein, in addition to those discussed above, may be appreciated by those skilled in the art.

[0061] The foregoing discussion has broad applicability and is presented for purposes of illustration and explanation, and is not intended to limit the present disclosure to the form or 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, proportions, 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 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. While the present disclosure is presented in terms of embodiments, it should be understood that various individual features of the present subject matter need not all be present to achieve at least some of the desired properties and / or advantages of the present subject matter or such individual features. Those skilled in the art will understand that the present disclosure can be used with many modifications, or modifications of the structure, arrangement, proportions, materials, components, and the like used in implementing the disclosure, that are particularly adapted to particular environments and operating requirements, without departing from the principles or spirit or scope of the disclosure. For example, elements shown as integrally formed may be comprised of multiple pieces, or elements shown as multiple pieces may be integrally formed, operations of elements may be reversed or changed, and sizes or dimensions of elements may be changed. Similarly, although operations or actions or steps are described in a particular order, this should not be construed as requiring such a specific order to achieve desirable 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 operations recited in the claims can be performed in a different order and still achieve desirable results.The presently disclosed embodiments are therefore to 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 to the specific embodiments or configurations described or illustrated herein. In view of the above, individual features of any embodiment may be used and claimed separately or in combination with features of that embodiment 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.

[0062] In the foregoing description and in the claims that follow, it will be understood that: As used herein, the terms "at least one," "one or more," and "and / or" are open-ended expressions that are both conjunctive and disjunctive in operation. Terms such as "a," "an," "the," "first," and "second" do not exclude 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, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used for identification purposes only to aid the reader's understanding of this disclosure and / or serve to distinguish regions of related elements from one another and do not limit the related elements, particularly with respect to the location, orientation, or use of this disclosure. Connection references (e.g., attached, coupled, connected, engaged, and coupled) should be interpreted broadly and may include intermediate members between and relative movement between sets of elements, unless otherwise indicated. Thus, connection references do not necessarily suggest 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.

[0063] The following claims are incorporated by reference into this detailed description, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the term "comprises" 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, they may be advantageously combined, and their 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. 1. A tissue retraction system comprising: a tissue retraction device including a pair of legs biased toward each other by a biasing portion; a delivery shaft defining a lumen through which the tissue retraction device can be delivered to a treatment site; Equipped with the tissue retraction device is transitionable between a delivery configuration and a deployed configuration; the legs of the tissue retraction device include tissue engaging tips configured to engage tissue; the delivery shaft is configured to maintain the tissue retraction device in the delivery configuration; A tissue retraction system, wherein in the deployed configuration, the biasing portion of the tissue retraction device exerts a traction force on tissue through legs of the tissue retraction device to pull tissue away from a treatment site.

2. The tissue retraction system of claim 1 , wherein the biasing portion connects the legs of the tissue retraction device.

3. The tissue retraction system of claim 1 or 2, wherein the biasing portion biases the legs of the tissue retraction device away from each other to lift tissue away from a treatment site.

4. 4. The tissue retraction system of claim 1, wherein the biasing portion biases the legs of the tissue retraction device toward each other to lift tissue away from a treatment site and toward anchoring tissue spaced from the treatment site.

5. 5. The tissue retraction system of claim 1, wherein at least one of the tissue engaging tips extends from one of the legs laterally relative to the one of the legs and in a direction in which the biasing portion biases the one of the legs.

6. The tissue retraction system of claim 5 , wherein the at least one of the tissue engaging tips extends from a free end of one of the legs.

7. 7. The tissue retraction system of claim 6, wherein the biasing portion biases the legs of the tissue retraction device away from one another, and wherein a tissue engaging tip extends from a free end of each of the legs in a direction away from the other of the legs.

8. The tissue retraction system of claim 6 , wherein the biasing member biases the legs of the tissue retraction device toward each other.

9. The tissue retraction system of any one of claims 1 to 8, wherein the tissue engaging tip of the tissue retraction device is disposed within a seat defined within the delivery shaft.

10. The tissue retraction system of any one of claims 1 to 9, further comprising a pusher configured to push the tissue retraction device out of the delivery shaft.

11. The tissue retraction system of claim 10 , wherein the pusher is releasably coupled to the tissue retraction device.

12. The tissue retraction system of any one of claims 1 to 11, further comprising a plurality of tissue retraction devices maintained in a delivery configuration within the lumen of the delivery shaft for delivery to a treatment site.

13. 1. A tissue retraction device comprising a pair of legs biased toward each other by a biasing portion, the tissue retraction device is transitionable between a delivery configuration in which the tissue retraction device is deliverable through a lumen of a delivery shaft and a deployed configuration in which the biasing portion of the tissue retraction device exerts a traction force on tissue to pull the tissue away from a treatment site; At least one of the legs of the tissue retraction device includes a tissue engaging tip configured to engage tissue and extending from a free end of the at least one of the legs in a direction transverse to the at least one of the legs.

14. 14. The tissue retraction system of claim 13, wherein the biasing portion biases the legs of the tissue retraction device away from one another, and the tissue engaging tip extends from the free end of the at least one of the legs of the tissue retraction device in a direction away from the other of the legs of the tissue retraction device.

15. 14. The tissue retraction system of claim 13, wherein the biasing portion biases the legs of the tissue retraction device toward one another, and the tissue engaging tip extends from the free end of the at least one leg of the tissue retraction device in a direction toward the other leg of the tissue retraction device.

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