Devices, systems and methods for tissue retraction

Abstract

A tissue retraction device having a target tissue engaging segment and two or more traction tissue engaging segments spaced apart from the target tissue engaging segment. The tissue retraction device may have a circumferential section with at least one traction tissue engaging segment therein, at least one of the traction tissue engaging segments being defined on such traction tissue engaging section. Further traction tissue engaging segments may be defined within the circumferential section, optionally on the further traction tissue engaging section, and / or within the at least one traction tissue engaging section. One or more traction tissue engaging segments within the circumferential section may be engaged simultaneously and / or sequentially with the traction tissue to achieve a change in the force vector of the traction force on the target tissue. A hanger may be provided on the tissue engaging member or on the circumferential section of the tissue retraction device to hold one or more of the traction tissue engaging segments extending from within the circumferential section of the tissue retraction device to the traction tissue.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to the field of implantable medical devices. In particular, the present disclosure relates to medical devices, systems, and methods for cardiac treatment. [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 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 retracted tissue 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 increased procedure time, complexity, and risk of perforation or bleeding. Thus, improvements in tissue retraction devices, systems, and methods would be welcomed by medical professionals. Summary of the Invention [Means for solving the problem]

[0003] 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.

[0004] In accordance with various principles of the present disclosure, a tissue retraction system includes a tissue retraction device defining a target tissue engaging segment engageable with a target tissue; a tissue engaging member configured to engage the at least one retracting tissue engaging segment with the retracting tissue; and a hanger configured to hold the at least one retracting tissue engaging segment adjacent to the retracting tissue.

[0005] In some embodiments, the tissue retraction device includes a peripheral section defining a periphery, and at least one retracting tissue-engaging segment is provided within the periphery of the peripheral section of the tissue retraction device. In some embodiments, the target tissue-engaging segment is defined along the peripheral section. In some embodiments, the peripheral section is in the form of a loop, and at least one retracting tissue-engaging segment within the peripheral section is defined on a loop-shaped retracting tissue-engaging section within the peripheral section. In some embodiments, the target tissue-engaging segment is defined along the peripheral section, and the loop-shaped retracting tissue-engaging section within the peripheral section is internally tangent with the peripheral section adjacent the target tissue-engaging segment. In some embodiments, the tissue retraction system includes an additional retracting tissue-engaging segment within the peripheral section. In some embodiments, the additional retracting tissue-engaging segment is defined on a additional loop-shaped retracting tissue-engaging section within the peripheral section. In some embodiments, the target tissue engaging segment is defined along the circumferential section; the further loop-shaped traction tissue engaging section is within the loop-shaped traction tissue engaging section; and the circumferential section, the loop-shaped traction tissue engaging section, and the further loop-shaped traction tissue engaging section are inscribed adjacent to the target tissue engaging segment.

[0006] In some embodiments, the hanger is on the tissue engaging member. In some embodiments, the hanger is on a tissue retraction device. In accordance with various principles of the present disclosure, a tissue retraction device includes a circumferential section defining a perimeter of the tissue retraction device and a first retracting tissue engaging section extending within the perimeter of and coupled to the perimeter section.

[0007] In some embodiments, the circumferential section defines a target tissue engaging segment engageable with the target tissue, and the first traction tissue engaging section is spaced from the target tissue engaging segment and defines at least one traction tissue engaging segment engageable with the traction tissue. In some embodiments, the circumferential section and the first traction tissue engaging section are each in the form of a loop; and the first traction tissue engaging section internally abuts the circumferential section adjacent the target tissue engaging segment.

[0008] In some embodiments, the tissue retraction device includes a second retracting tissue-engaging section within the circumferential section. In some embodiments, the second retracting tissue-engaging section is within the first retracting tissue-engaging section. In some embodiments, the circumferential section defines a target tissue-engaging segment engageable with the target tissue; the circumferential section, the first retracting tissue-engaging section, and the second retracting tissue-engaging section are each in the form of a loop; and the first retracting tissue-engaging section and the second retracting tissue-engaging section are internally bounded by the circumferential section adjacent the target tissue-engaging segment.

[0009] In some embodiments, the circumferential section defines a target tissue engaging segment engageable with the target tissue and a traction tissue engaging segment spaced from the target tissue engaging segment and engageable with the traction tissue, and the tissue retraction device may further include a hanger on the circumferential section adjacent to the traction tissue engaging segment configured to hold the traction tissue engaging segment of the first traction tissue engaging section adjacent to the traction tissue.

[0010] In accordance with various principles of the present disclosure, the tissue engaging member includes grasper arms engageable with tissue and a hanger configured to hold at least one retracting tissue engaging segment of the tissue retraction device spaced from the grasper arms and adjacent the tissue.

[0011] In some embodiments, the tissue engaging member includes a capsule extending around the gripping arms, the gripping arms being retractable into the capsule to transition to a closed configuration that holds tissue between the gripping arms, and a hanger extending from the capsule.

[0012] In some embodiments, the gripping arms are further engageable with another retracting tissue engaging segment of the tissue retraction device to cause the other retracting tissue engaging segment of the tissue retraction device to engage tissue.

[0013] 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]

[0014] [Figure 1] 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. [Diagram 2] An example of an environment as in FIG. 1 is shown, in which an example embodiment of a traction device and system as in FIG. 1 is further implemented. [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] 2 illustrates an example environment in which example embodiments of retraction devices and systems similar to those of FIG. 1, but with modified tissue engaging members, are implemented. [Diagram 5] 5 shows an example of an environment and tissue retraction device and system as in FIG. 4 with additional traction forces applied. [Figure 6]6 shows an example of an environment and tissue retraction device and system as in FIG. 4 and FIG. 5, where additional traction forces are applied. [Figure 7] 1 and 4, but with a modified tissue retraction device, illustrates an example of an environment in which an example embodiment of a retraction device and system is implemented. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] 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 delivery catheter or working channel of an endoscope. In the figures, identical or nearly identical or equivalent elements are usually represented by the same reference character, and similar elements are usually designated by similar reference numbers that differ in increments of 100, and redundant descriptions are omitted. For purposes of clarity and conciseness, not all elements are labeled in every figure, 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.

[0016] 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.

[0017] 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.

[0018] 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 the free end.

[0019] 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 thereof).

[0020] 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 be inefficient for physicians. 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 in the way of the instruments used to perform 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.

[0021] 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. Tissue retraction devices (sometimes referred to interchangeably herein as tethers for convenience and without any intent of limitation) may be traction bands, elastic bands, stretchable elongated members, wires, cords, cables, springs, sutures, and / or any other suitable members that are optionally stretchable and / or extendable. Tethers 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 retraction devices formed in accordance with various principles of the present disclosure.

[0022] The tissue retraction device may engage tissue at the target tissue site with a tissue engaging member, which may alternatively be referred to herein, without limitation, as a tissue fastener or clip or other mechanical fixation device (e.g., hemostatic clip, clamp, grasper, basket, gripper, magnet, adhesive, etc.). It will be understood that references "at" the target tissue site are intended to include tissue at and adjacent the target tissue, and are not limited to only the target tissue. It will be understood that terms such as engage (and other grammatical forms of engage) may be used interchangeably herein, without limitation, with terms such as connect, grasp, hold, fasten, clip, secure, attach, affix, secure, etc. (and other grammatical forms of these). The tissue engaging member is optionally formed separately from the tissue retraction device. In some embodiments, the tissue engaging member is repositionable after being partially deployed. For example, the tissue engaging member may be configured to allow the tissue engaging member to be releasably engaged with tissue (e.g., closed to engage but not locked) when in a first configuration and locked from releasing engagement with tissue when in a second closed configuration. In some embodiments, the tissue engaging member has gripping arms or jaws that are selectively movable away from one another to engage tissue therebetween and toward one another to grip 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 and / or along the ends 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 (eg, 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 a particular form or configuration of the tissue engaging member. In some embodiments, the tissue retraction device is delivered to a target tissue site with a tissue engaging member coupled thereto.

[0023] In accordance with various principles of the present disclosure, the tissue retraction device has a target tissue engaging section or segment configured and positioned to engage tissue at a target tissue site. Such engagement of the target tissue engaging segment with tissue may be direct or indirect, for example, involving the 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. Another section of the tissue retraction device is then engaged with tissue remote from the target tissue (and without any intention of limitation, referred to herein as the first retraction tissue site), such as in a manner that allows the tissue retraction device to apply a traction force to the target tissue. A second tissue engaging member may be used to engage the retraction tissue engaging 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 applied thereto by the tissue retraction device may decrease. In accordance with various principles of the present disclosure, rather than increasing the tension on the target tissue by moving the retraction tissue-engaging section of the tissue retraction device to another location, one or more additional retraction tissue-engaging sections of the tissue retraction device may be engaged with the retraction tissue to increase the traction applied to the target tissue site. It should be understood that the additional retraction tissue-engaging sections of the tissue retraction device may be engaged at essentially the same retraction tissue site (depending on the size, shape, configuration, and / or location of the various retraction tissue-engaging sections) or at different retraction tissue sites (such as increasingly distant from the target tissue). For example, if the distance between the target tissue and the various retraction tissue-engaging sections of the tissue retraction device is different, different force vectors of traction may be applied by the different retraction tissue-engaging segments even when engaged at a common retraction tissue site.

[0024] 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. Terms such as section or segment or area or portion may be used interchangeably herein without any limitation intended, and it will be understood that a gripping segment of a tissue retraction device is referred to as a section that is distinct from another section of the tissue retraction device. Different sections of the tissue retraction device may be differentiated from one another by differences in shape or orientation relative to another gripping segment of the tissue retraction device, such as, but not limited to, adjacent or adjoining a gripping segment, into different gripping segments defined along a section of the tissue retraction device.

[0025] In one aspect, a tissue retraction device may be formed according to various principles of the present disclosure with an outer or peripheral section defining one or more gripping segments therealong and one or more gripping segments defined within the periphery of the peripheral section. The gripping segments defined along or within the peripheral section of the tissue retraction device may engage target tissue to which traction is applied and may be referred to herein as target tissue-engaging segments. One or more of the gripping segments defined along or within the peripheral section of the tissue retraction device may engage traction tissue spaced from the target tissue to apply traction to the target tissue. Such segments may be referred to herein as traction-tissue-engaging segments. In accordance with various principles of the present disclosure, the traction-tissue-engaging sections may be at progressively greater distances from the traction tissue and / or at progressively lesser distances from the target tissue, such that engagement of different ones of such traction-tissue-engaging segments to substantially the same traction tissue site changes the force vector of the traction force applied by the tissue retraction device. Thus, tissue retraction devices formed in accordance with various principles of the present disclosure 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 spaced from the target tissue to vary the force vector of the traction imparted to the target tissue, thereby improving the utility of the tissue retraction device.

[0026] In some embodiments, the tissue retraction device has a circumferential section in the form of a loop. In some embodiments, one or more additional sections, such as in the form of additional loops, are formed within the circumferential section. For example, in some embodiments, each of the additional loops is disposed within another loop. In other words, the loops are nested within one another. In some embodiments, the nested loops are generally interconnected such that all of the loops together form the tissue retraction device as a whole (not as separate loops, but as an integral element in a single piece). In some embodiments, the loops are inwardly abutted along a common section of the tissue retraction device. For example, in some embodiments, all of the connected nested loops are connected at a common section of the tissue retraction device, such as along a target tissue engaging segment of the tissue retraction device. Thus, an increasing amount of traction force may be applied to the target tissue as each of the smaller loops in the outermost loop (e.g., the circumferential section of the tissue retraction device) is stretched to engage retracted tissue away from the target tissue. A medical professional can have a sense of the difference in the applied traction force by comparing the relative sizes of the inner loops that are grasped to engage the retracted tissue. Furthermore, when each of the nested loops within the circumferential section of the tissue retraction device is coupled to the circumferential section within the overall area of ​​the target tissue engagement segment, the traction force imparted by engaging the retracting tissue with one of the nested loops is generally imparted more directly to the target tissue than if the nested loop were coupled to another area of ​​the circumferential section, and the traction force vector may be modified as desired by the user.

[0027] A tissue retraction device formed according to various principles of the present disclosure allows a medical professional to vary the force vector applied to a target tissue to apply traction to the target tissue. For example, engaging a first segment of the tissue retraction device with a first region of the tissue (such as, but not limited to, the target tissue) and then engaging a different segment of the tissue retraction device with a different region of the tissue remote from the first region of the tissue (sequentially or simultaneously) allows various degrees or strengths of traction and / or various angles to be applied to the target tissue. If a medical professional needs to engage a target tissue engaging segment of the tissue retraction device with a target tissue site, engage a traction tissue engaging segment of the tissue retraction device with the traction tissue site, and then adjust the traction on the target tissue site (e.g., apply additional, larger traction force to the target tissue site or apply traction force at a different angle), an additional traction tissue engaging segment of the tissue retraction device may be engaged with the retraction tissue or at an additional traction tissue site remote from the retraction tissue to apply a larger amount of traction force and / or traction force at a different angle to the target tissue.

[0028] In some embodiments, the tissue engaging member is configured to be engageable with two or more segments of a tissue retraction device according to various principles of the present disclosure to engage two or more retracting tissue engaging segments of the tissue retraction device with substantially the same retracting tissue. In some embodiments, a retraction device hanger is formed on a portion of the tissue engaging member and is sized, shaped, configured, and / or dimensioned to receive two or more segments of a tissue retraction device formed according to various principles of the present disclosure with multiple retracting tissue engaging segments.

[0029] In some embodiments, a tissue retraction device formed in accordance with various principles of the present disclosure (such as with two or more retracting tissue-engaging segments) includes a retraction device hanger that is sized, shaped, configured, and / or dimensioned to receive the two or more retracting tissue-engaging segments of the tissue retraction device. In such embodiments, the size / degree of the tissue retraction device is altered by coupling one or more retracting tissue-engaging segments to the hanger to vary the traction force applied to the retracting tissue with which the tissue retraction device is engaged.

[0030] Various embodiments of tissue retraction devices, systems, and methods of use thereof will now be described with reference to examples shown 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 association with the embodiments. However, such references do not necessarily mean that all embodiments include the particular feature, structure, and / or characteristic, 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. Furthermore, 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 should be understood that when a particular feature, structure, and / or characteristic is described in association with one embodiment, such feature, structure, and / or characteristic may also be used in association with other embodiments, whether or not expressly described, unless expressly stated to the contrary. It is further understood that such features, structures, and / or characteristics may be used or present alone or in various combinations with one another to create alternative embodiments that are considered part of this disclosure, since it would be prohibitively cumbersome to describe all of the many possible combinations and subcombinations of features, structures, and / or characteristics. Additionally, 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.

[0031] In the embodiments shown in the drawings, common features are identified by common reference elements, and it will be understood that for brevity and convenience, without intending to be limiting, descriptions of common features are generally not repeated. For clarity, not all components having the same reference number are numbered. Furthermore, certain features in one embodiment may be used across different embodiments and are not necessarily individually numbered when appearing in different embodiments.

[0032] 1 and 2, an example of the use of a tissue retraction device 100 according to various principles of the present disclosure is shown. An example of an embodiment of a tissue retraction device 100 formed according to various principles of the present disclosure and that may be used as shown in FIG. 1 and FIG. 2 is shown in FIG. 3. The tissue retraction device 100 has a target tissue engagement end 101 that is engaged (directly or indirectly, such as by use of a tissue engagement member 200 described in further detail below) with a target tissue TA at a target tissue site TS, and a traction tissue engagement end 103 that is engaged (directly or indirectly, such as by use of a tissue engagement member 200) with a traction tissue TR1 spaced from the target tissue TA. When so engaged, the tissue retraction device 100 applies a traction force to the target tissue TA. It should be understood that references to a first end or a second end of the tissue retraction device are for simplicity and should not be understood as being limited to the ends of an elongated element, and may apply to other locations along an element, such as, but not limited to, an elongated element.

[0033] As can be seen with reference to FIG. 3, the illustrated example of an embodiment of a tissue retraction device 100 formed according to various principles of the present disclosure has a circumferential section 110 with one or more additional retraction sections 120, 130. The circumferential section 110 is generally in the shape of a loop, e.g., a closed shape such as a circle, an oval, or the like, although other shapes are within the scope and spirit of the present disclosure. The circumferential section 110 includes a target tissue engaging segment 112 along the target tissue engaging end 101 of the tissue retraction device 100 and a retraction tissue engaging segment 114 at a location spaced apart from the target tissue engaging segment 112. In the example of use shown in FIGS. 1 and 2, the target tissue engaging segment 112 engages the target tissue TA and the retraction tissue engaging segment 114 engages the retraction tissue TR1. It should be understood that other orientations and configurations are within the scope of the present disclosure and that the particular locations along the tissue retraction device 100 engaged with the target tissue TA and the retraction tissue TR1 are not limited to those illustrated and shown in the drawings. Further retraction sections 120, 130 may be defined relative to the circumferential section 110, such as within a perimeter defined by the circumferential section 110. As described in further detail below, the further retraction sections 120, 130 may extend to tissue spaced apart from the target tissue area TA, such as retraction tissue TR1 or retraction tissue TR2, as illustrated in Figure 2. As can be appreciated, the further retraction force on the target tissue TA lifts the target tissue TA further away from the surrounding tissue, allowing a procedure performed on or along the target tissue TA to continue without interference from the lifted section of the target tissue TA.

[0034] In some embodiments, as shown in Figures 1 and 2, a tissue engaging member 200 is used to engage the target tissue engaging segment 112 with the target tissue TA. Alternatively, or additionally, a tissue engaging member 202 is used to engage the retracting tissue engaging segment 114 of the tissue retraction device 100 with the retracting tissue TR1. In the example embodiment shown in Figures 1 and 2, the tissue engaging members 200, 202 are adjustable clips (such as hemostatic clips) having first and second gripping arms 210 (which may alternatively be referred to as jaws herein, 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 210 to be engaged by the gripping arms 210. In the closed configuration, the gripping arms 210 engage or hold tissue therebetween. In some embodiments, the tissue engaging member 200 includes a capsule 220 into which the proximal ends of the gripping arms 210 can be retracted to transition the tissue engaging member 200 to a closed configuration, and from which the gripping arms 210 can be extended to transition the tissue engaging member 200 to an open configuration. A controller (not shown, the configuration of which is known to those skilled in the art and does not form part of this disclosure) may be operatively coupled to the gripping arms 210 to actuate movement of the gripping arms 210 (e.g., relative to the capsule 220) between the open and closed configurations. The controller may be separable from the tissue engaging member 200 once a desired position and / or configuration of the tissue engaging member 200 has been achieved or reached. The gripping arms 210 may be locked in place relative to the capsule 220 once a desired position, configuration, etc. of the gripping arms 210 has been achieved by any of a variety of mechanisms known to those skilled in the art, and the present disclosure is not limited by such structure or features. The tissue engaging member 200 may be configured to engage tissue as well as the target tissue engaging segment 112 and / or the retracting tissue engaging segment 114 of the tissue retraction device 100. Thus, the target tissue engaging segment 112 and / or the retracting tissue engaging segment 114 of the tissue retraction device 100 need not directly engage the tissue but may engage the tissue via the tissue engaging member 200.

[0035] The endoscope 300 is shown in FIGS. 1 and 2 as delivering the tissue manipulation device 400 to the target tissue site TS to manipulate the target tissue TA to which traction is being applied by the tissue retraction device 100. In the illustrated example, the tissue manipulation device 400 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, it is lifted and some of the traction force exerted by the tissue retraction device 100 is relieved. As shown in FIG. 2, to increase the traction force on the target tissue TA, the further retraction section 120 is extended to a further retraction tissue TR2 spaced apart from the retraction tissue TR1 with which the retraction tissue engaging segment 114 is engaged (as shown in FIG. 2) or to the same target tissue TT1 with which the retraction tissue engaging segment 114 is engaged (as shown in FIGS. 4, 5, 6, and 7, as discussed in more detail below). The further retraction section 120 may be engaged with the further retraction tissue TT1, TT2 along the retraction tissue engaging segment 124 along the further retraction section 120. 3 along the retracting tissue engaging end 103 of the tissue retraction device 100, the retracting tissue engaging segments 124 of the further retraction section 120 may be disposed at other locations along the further retraction section 120. It should be understood that the tissue manipulation device 400 or another device (e.g., an end effector, hook, grasper, etc.) may be used to engage the further retraction sections 120, 130 of the tissue retraction device 100 with the retracting tissue.

[0036] In one example embodiment of the tissue retraction device 100 illustrated in FIG. 3, the additional retraction sections 120, 130 are in the form of loops positioned one within the other and coupled / extending from the target tissue engaging segment 112 of the circumferential section 110 of the tissue retraction device 100. The additional retraction sections 120, 130 may be coupled with the circumferential section 110 along their target tissue engaging segments 112 to, for example, direct retraction to the target tissue, optimize the distance the additional retraction sections extend from target tissue to target tissue, generate a generally linear force vector applied between the retracted tissue and the target tissue, and vary the force vector (e.g., magnitude and / or direction). Tissue retraction devices 100 formed according to various principles of the present disclosure may have additional internal retraction sections within the illustrated additional retraction sections 120, 130, and the present disclosure is not limited to a particular number of additional retraction sections. Each additional retraction section may be engaged (directly or indirectly) with additional retraction tissue that may be gradually moved away from the retraction tissue with which the retraction section of the tissue retraction device 100 is already engaged, or may generally be engaged with the same retraction tissue site to apply greater traction forces to the target tissue and / or to adjust the angle of traction applied to the target tissue.

[0037] It will be appreciated that tissue retraction devices formed according to various principles of the present disclosure allow a medical professional to vary the force vector of traction applied to a target tissue by engaging one or more segments of the tissue retraction device with the retracting tissue (at the same site or at spaced sites) to facilitate the performance of any of a variety of procedures on or around the target tissue. For example, as the target tissue is resected, 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 an initial retracting 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 additional retracting tissue-engaging segments of the tissue retraction device may be engaged with the retracting tissue (simultaneously and / or sequentially). Although the retracting tissue sites may be spaced apart from one another, as shown in Figures 1 and 2, additional retraction sections 120, 130 (etc.) of tissue retraction device 100 formed according to various principles of the present disclosure may instead all engage retracting tissue within substantially the same tissue area, as in the examples of use shown in Figures 4, 5, 6, and 7.

[0038] It should be appreciated that engaging two or more segments or sections of a tissue retraction device with tissue in approximately the same region or area or point may present various challenges. For example, when different tissue engaging members are used, generally a limited number of tissue engaging members may be engaged with tissue at a particular tissue site. When the same tissue engaging member is used to engage one or more segments or sections of a tissue retraction device with tissue, there is a risk that one or more segments or sections of the tissue retraction device may inadvertently become dislodged from the tissue engaging member. For example, a tissue engaging member in the form of a clip having gripping arms that can be shifted between an open configuration and a closed configuration may lose grip on a segment or section of the tissue retraction device while attempting to engage or maintain engagement with another segment or section of the tissue retraction device.

[0039] To facilitate engaging two or more retracting tissue engaging segments or sections of a tissue retraction device with a common retracting tissue site (approximately at the same location, spaced apart from the target tissue to which the tissue retraction device is initially engaged), a modified tissue engaging member may be used for all of the retracting tissue engaging segments or sections that are engaged with the common retracting tissue site. An example embodiment of a modified tissue engaging member 1200 formed in accordance with various principles of the present disclosure is shown in FIGS. 4, 5, and 6. In accordance with various principles of the present disclosure, the modified tissue engaging member 1200 is configured for engaging two or more segments or sections of a tissue retraction device 100 (such as one formed in accordance with various principles of the present disclosure or another tissue retraction device), such as by engaging at least one segment or section of the tissue retraction device 100 with a gripping arm 1210 of the tissue engaging member 1200 and engaging one or more other segments or sections of the tissue engaging member 1200 with another structure of the tissue engaging member 1200. For example, in the example embodiment shown in Figures 4, 5, and 6, the modified tissue engaging member 1200 has a modified capsule 1220 configured to engage one or more other segments or sections of the tissue engaging member 1200. The modified capsule 1220 may include a hanger 1230, either integrally formed with the capsule 1220 or separately formed and coupled thereto. The hanger 1230 is sized, shaped, configured, and / or dimensioned to engage one or more segments or sections of a tissue retraction device and to hold such segments or sections in engagement with the tissue engaging member 1200. For example, the hanger 1230 may include an arm 1232 extending away from the capsule 1220 (e.g., generally transversely to a wall of the capsule) and a hook 1234 extending transversely to the arm 1232, as can be understood with reference to Figure 4. The arms 1232 and hooks 1234 may be dimensioned to engage two or more sections or segments of the tissue retraction device 100 with the hanger 1230 and hold them against the tissue engaging member 1200.The hook 1234 may be sized, shaped, configured, and / or dimensioned relative to the arm 1232, etc., to hold two or more sections or segments of the tissue retraction device 100 in engagement with the arm 1232. It will be understood that hanger configurations other than the illustrated hanger 1230 are within the scope and spirit of the present disclosure.

[0040] As illustrated in Fig. 4, the target tissue engaging segment 112 of the tissue retraction device 100 as described above may be engaged with the target tissue TA (optionally with the use of the tissue engaging member 200 as described above), and the retracting tissue engaging segment 114 of the tissue retraction device 100 may be engaged with the retracted tissue TR using the modified tissue engaging member 1200 as described above. As the target tissue TA is manipulated or moved relative to the surrounding tissue in the target tissue area TA and the traction force on the target tissue TA is reduced, the device 500 (an end effector, hook, grasper, etc., or tissue manipulation device 400 used on the target tissue TA as shown in Fig. 1 or Fig. 2) may engage another section or segment of the tissue retraction device 100 with the modified tissue engaging member 1200, such as by hooking one or more of the additional retraction sections 120, 130 of the tissue retraction device 100 onto the hanger 1230. In the example shown in Fig. 5, the additional retraction section 120 is engaged with the hanger 1230. However, it should be understood that another additional tow section, such as a smaller additional tow section 130, may be engaged with the hanger 1230 before or after the illustrated additional tow section 120, or in place of it. For example, two or more additional tow sections 120, 130 may be engaged with the hanger 1230, as shown in FIG.

[0041] Instead of engaging additional sections or segments of the tissue retraction device with the same tissue engaging member and engaging such additional sections or segments with substantially the same retracted tissue TR, the additional sections or segments may be engaged with structures on the modified tissue retraction device 1100, as shown in FIG. 7. More specifically, the example embodiment of the modified tissue engaging member 1200 shown in FIG. 7 includes a hanger 1150 that is integrally formed with or separately formed and coupled to the circumferential section 1110 of the modified tissue retraction device 1100. The hanger 1150 is sized, shaped, configured, and / or dimensioned for engagement therewith of two or more segments or sections of the modified tissue retraction device 1110, as well as to engage and hold such segments or sections with the hanger 1150. For example, the hanger 1150 may include one or more arms 1152 having one or more hooks 1154 extending laterally relative to the arms 1152. The arm 1152 and hook 1154 may be dimensioned to engage and hold two or more sections or segments of the modified tissue retraction device 1100 with the hanger 1150. The hook 1154 may be sized, shaped, configured, and / or dimensioned relative to the arm 1152, etc., to engage and hold two or more sections or segments of the modified tissue retraction device 1100 with the arm 1152. It will be understood that other configurations of hangers other than the illustrated hanger 1150 are within the scope and spirit of the present disclosure.

[0042] It will be understood that various modifications to tissue retraction devices 100, 1100 formed according to various principles of the present disclosure may be made without departing from the scope and spirit of the present disclosure. For example, the thickness of one or more sections of tissue retraction devices 110, 1110 formed according to various principles of the present disclosure need not be the same. For example, thicker areas or regions of additional retraction sections 120, 130 may be provided to increase the resistance to elongation of such sections, to increase the traction force applied by such sections, etc. Alternatively, or additionally, at least one retraction section may be formed from a different material (e.g., different material compositions, such as different elastomers, with similar material compositions but different properties, such as different elastic moduli and / or durometers, etc.). Alternatively, or additionally, the different retraction sections need not all be coplanar. Alternatively, or additionally, additional retraction sections may be provided within the illustrated retraction sections and / or along other locations on the tissue retraction device. Alternatively or additionally, the additional traction sections shown are shown inside one another, but other configurations are within the scope and spirit of the present disclosure. Alternatively or additionally, the additional traction sections shown are shown inside one another, inscribed within each other, but other configurations are within the scope and spirit of the present disclosure. Alternatively or additionally, the additional traction segments shown are shown inside one another, inscribed within the interior of the perimeter section, but other configurations are within the scope and spirit of the present disclosure. Alternatively or additionally, the shapes of the additional traction segments shown are substantially similar, but other configurations are within the scope and spirit of the present disclosure. Alternatively or additionally, other configurations of the perimeter section and / or additional traction sections are within the scope and spirit of the present disclosure.

[0043] 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. 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.

[0044] All devices and methods described herein are examples of devices and / or methods implemented according to one or more principles of the present disclosure. These examples are not the only ways to implement these principles, but are merely examples and are not intended as limiting the broader aspects of the present disclosure. Thus, references to elements or structures or features in the drawings should be recognized as references to examples of embodiments of the present disclosure and should not be understood as limiting the present 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. 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.

[0045] 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 altered, and elements may be altered 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 or that all operations or actions or steps should be performed to achieve desired results. 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.

[0046] 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.

[0047] 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 traction system comprising: a tissue retraction device defining a target tissue engaging segment engageable with a target tissue and at least two retracting tissue engaging segments spaced from the target tissue engaging segment and engageable with retracting tissue; a tissue engaging member configured to engage at least one traction tissue engaging segment with the traction tissue; a hanger configured to hold at least one traction tissue engaging segment adjacent the traction tissue; A tissue retraction system comprising:

2. The tissue retraction system of claim 1 , wherein the tissue retraction device comprises a peripheral section defining a perimeter, and the at least one retracting tissue engaging segment is provided within a perimeter of the peripheral section of the tissue retraction device.

3. The tissue retraction system of claim 2 , wherein the target tissue engaging segment is defined along the circumferential section.

4. the circumferential section is in the form of a loop; and The tissue retraction system of claim 1 , wherein the at least one traction tissue-engaging segment within the circumferential section is defined on a loop-shaped traction tissue-engaging section within the circumferential section.

5. The target tissue engaging segment is defined along the circumferential section; and The tissue retraction system of claim 4 , wherein the loop-shaped retracting tissue-engaging section within the perimeter section inwardly abuts the perimeter section adjacent the target tissue-engaging segment.

6. The tissue retraction system of any one of claims 1 to 5, further comprising an additional retracting tissue engaging segment within the circumferential section.

7. The tissue retraction system of claim 6 , wherein the further traction tissue-engaging segment is defined on a further loop-shaped traction tissue-engaging section within the circumferential section.

8. The target tissue engaging segment is defined along the circumferential section; the further loop-shaped traction tissue-engaging section is within the loop-shaped traction tissue-engaging section; and 8. The tissue retraction system of claim 6 or 7, wherein the circumferential section, the loop-shaped traction tissue engaging section, and the further loop-shaped traction tissue engaging section abut internally adjacent the target tissue engaging segment.

9. The tissue retraction system of any one of claims 1 to 8, wherein the hanger is on the tissue engaging member or the tissue retraction device.

10. 1. A tissue retraction device comprising: a circumferential section defining a periphery of the tissue retraction device; a first traction tissue engaging section extending within a perimeter section and coupled to the perimeter section; A tissue retraction device comprising:

11. the circumferential section defines a target tissue engaging segment engageable with a target tissue; and The tissue retraction device of claim 10 , wherein the first retracting tissue engaging section defines at least one retracting tissue engaging segment spaced from the target tissue engaging segment and engageable with retracting tissue.

12. the circumferential section and the first traction tissue-engaging section are each in the form of a loop; and The tissue retraction device of claim 10 or claim 11, wherein the first retracting tissue engaging section inwardly abuts the circumferential section adjacent the target tissue engaging segment.

13. The tissue retraction device of any one of claims 10 to 12, further comprising a second retracting tissue engaging section within the circumferential section.

14. The tissue retraction device of claim 13 , wherein the second retracting tissue engaging section is within the first retracting tissue engaging section.

15. the peripheral section defines a target tissue engaging segment engageable with a target tissue and a traction tissue engaging segment spaced from the target tissue engaging segment and engageable with a traction tissue; and The tissue retraction device of claim 10, further comprising a hanger configured to hold a traction tissue-engaging segment of the first traction tissue-engaging section adjacent to the traction tissue on the circumferential section adjacent to the traction tissue-engaging segment.

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