Devices and systems for organizational leadership

Abstract

The present invention provides a tissue traction device having a target tissue engagement segment and two or more traction tissue engagement segments spaced apart from the target tissue engagement segment. [Solution] The outer periphery section may have at least one traction tissue engagement segment, defined on the traction tissue engagement section. Further traction tissue engagement segments may be defined within the outer periphery section, optionally on further traction tissue engagement sections, and / or within at least one traction tissue engagement section. One or more traction tissue engagement segments within the outer periphery section may engage with the traction tissue simultaneously and / or in a manner that achieves a change in the force vector of the traction force on the target tissue. Hangers may be provided on the tissue engagement member or on the outer periphery section of the tissue traction device to hold one or more traction tissue engagement segments extending from within the outer periphery section of the tissue traction device to the traction tissue.

Description

Technical Field

[0001] The present disclosure generally relates to the field of implantable medical devices. In particular, the present disclosure relates to medical devices, systems, and methods for cardiac treatment.

Background Art

[0002] Various surgical procedures involve lifting or separating a target tissue (a designated section of tissue) at the treatment site, while the target tissue remains attached to the treatment site. Tissue traction elements 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 undesirable portion of tissue that is unhealthy, diseased (i.e., cancerous, precancerous, etc.), or otherwise healthy or unhealthy. "Target tissue" may also include tissue that is unhealthy or suspected to be diseased and requires 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. While these techniques can allow patients to recover faster and often with less pain than incision or laparoscopic surgical procedures, such techniques require a high level of expertise and are therefore not yet widely adopted. One of the biggest factors in terms of time and complexity is the management of the tissue being dissected / removed. As medical professionals cut tissue, visualization of the cut surface (the tissue being cut) becomes more difficult because the tissue remains above the cut surface, and because medical professionals need to continue cutting deeper into the tissue. Accurate and efficient endoscopic tissue resection / dissection requires the ability to maintain traction on the target tissue above the cut surface as the boundary of the target tissue is dissected and the tractioned tissue is lifted. Traction systems may not be able to maintain or regulate 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 auxiliary instruments. These complexities directly contribute to increased procedure time, complexity, and the risk of perforation or bleeding. Therefore, improvements in tissue traction devices, systems, and methods would be welcomed by medical professionals. [Overview of the Initiative] [Means for solving the problem]

[0003] This summary of the disclosure is provided for the purpose of aiding understanding, and those skilled in the art will understand that each of the various aspects and features of the disclosure may be used advantageously, in some cases separately or in other cases in combination with other aspects and features of the disclosure. No limitation on the scope of the claimed subject matter is intended by the inclusion or exclusion of elements, components, etc., in this summary.

[0004] In accordance with various principles of this disclosure, a tissue traction system includes: a tissue traction device defining a target tissue engagement segment that can engage with a target tissue; a tissue engagement member configured to engage at least one traction tissue engagement segment with a traction tissue; and a hanger configured to hold at least one traction tissue engagement segment adjacent to the traction tissue.

[0005] In some embodiments, the tissue traction device includes a peripheral section defining its periphery, and at least one traction tissue engagement segment is provided within the periphery of the tissue traction device. In some embodiments, the target tissue engagement segment is defined along the peripheral section. In some embodiments, the peripheral section is in the form of a loop, and at least one traction tissue engagement segment within the peripheral section is defined on the loop-shaped traction tissue engagement segment within the peripheral section. In some embodiments, the target tissue engagement segment is defined along the peripheral section, and the loop-shaped traction tissue engagement segment within the peripheral section is internally tangent with the peripheral section adjacent to the target tissue engagement segment. In some embodiments, the tissue traction system includes further traction tissue engagement segments within the peripheral section. In some embodiments, the further traction tissue engagement segments are defined on further loop-shaped traction tissue engagement segments within the peripheral section. In some embodiments, the target tissue engagement segment is defined along the outer periphery section; further loop-shaped traction tissue engagement sections are located within the loop-shaped traction tissue engagement sections; and the outer periphery section, the loop-shaped traction tissue engagement sections, and the further loop-shaped traction tissue engagement sections are inscribed adjacent to the target tissue engagement segment.

[0006] In some embodiments, the hanger is located on a tissue engagement member. In some embodiments, the hanger is located on a tissue traction device. In accordance with various principles of this disclosure, a tissue traction device includes an outer periphery section defining the periphery of the tissue traction device and a first traction tissue engagement section extending within the periphery of the outer periphery section and coupled to the outer periphery section.

[0007] In some embodiments, the outer periphery section defines a target tissue engagement segment that can engage with target tissue, and the first traction tissue engagement section defines at least one traction tissue engagement segment that is separated from the target tissue engagement segment and can engage with traction tissue. In some embodiments, the outer periphery section and the first traction tissue engagement section are each in the form of a loop; and the first traction tissue engagement section is in internal contact with the outer periphery section adjacent to the target tissue engagement segment.

[0008] In some embodiments, the tissue traction device includes a second traction tissue engagement section within the outer periphery section. In some embodiments, the second traction tissue engagement section is located within the first traction tissue engagement section. In some embodiments, the outer periphery section defines a target tissue engagement segment that can engage with target tissue; the outer periphery section, the first traction tissue engagement section, and the second traction tissue engagement section are each in the form of a loop; and the first and second traction tissue engagement sections are in internal contact with the outer periphery section adjacent to the target tissue engagement segment.

[0009] In some embodiments, the outer periphery section defines a target tissue engagement segment that can engage with target tissue and a traction tissue engagement segment that is separated from the target tissue engagement segment and can engage with traction tissue, and the tissue traction device may further include a hanger on the outer periphery section adjacent to the traction tissue engagement segment, configured to hold the traction tissue engagement segment of a first traction tissue engagement section adjacent to the traction tissue.

[0010] In accordance with various principles of this disclosure, the tissue engagement member includes a gripper arm capable of engaging with tissue and a hanger configured to hold at least one traction tissue engagement segment of a tissue traction device, which is separated from the gripper arm and adjacent to the tissue.

[0011] In some embodiments, the tissue engagement member includes a capsule extending around a gripping arm, the gripping arm 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 arm is further engageable with another traction tissue engagement segment of the tissue traction device, thereby engaging the other traction tissue engagement segment of the tissue traction device with the tissue.

[0013] These and other features and advantages of this disclosure will be readily apparent from the following detailed description, and the scope of the claimed invention is set forth in the attached claims. The following disclosure is presented with respect to aspects or embodiments, but it should be understood that each aspect may be claimed separately or in combination with the aspects and features of that embodiment or any other embodiment. [Brief explanation of the drawing]

[0014] [Figure 1] Examples of environments in which devices, systems, and methods conforming to the various principles of this disclosure may be used are shown, and examples of embodiments of traction devices and systems are demonstrated. [Figure 2] An example of an environment is shown in Figure 1, and further examples of embodiments of the traction device and system shown in Figure 1 have been implemented. [Figure 3] A plan view of an example of an embodiment of a traction device formed according to various principles of this disclosure is shown. [Figure 4] This shows an example of an environment in which an example of an embodiment of a traction device and system, similar to that in Figure 1 but with a modified tissue engagement member, is being implemented. [Figure 5] Figure 4 shows an example of an environmental and tissue traction device and system that provides additional traction. [Figure 6]Examples of environmental and tissue traction devices and systems, such as those shown in Figures 4 and 5, which provide additional traction, are presented. [Figure 7] This shows an example of an environment in which an example of an embodiment of a traction device and system is being implemented, similar to that in Figures 1 and 4, but with a modified tissue traction device. [Modes for carrying out the invention]

[0015] Non-limiting embodiments of this disclosure are described by reference to the accompanying drawings, which are schematic and not intended to be drawn to any particular scale. The accompanying drawings are provided for illustrative purposes only, and dimensions, positions, order, and relative sizes reflected in the drawings may be modified. For example, a device may be enlarged so that details are identifiable, but is intended to be reduced in relation to mating into, for example, a delivery catheter or an endoscope working channel. In the drawings, identical, nearly identical, or equivalent elements are usually represented by the same reference letter, similar elements are usually designated by similar reference numbers different in increments of 100, and redundant descriptions are omitted. For the purposes of clarity and brevity, not all elements are coded in all drawings, nor are all elements of each embodiment shown where illustration is not necessary to enable a person skilled in the art to understand this disclosure.

[0016] A more detailed explanation will be better understood in conjunction with the attached diagrams, where similar reference letters represent similar elements, as shown below. The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. It should be understood that this disclosure is not limited to the specific embodiments described and is therefore modifiable. All devices, systems, and methods discussed herein are examples of devices and / or systems and / or methods implemented in accordance with one or more principles of this disclosure. Each example of an embodiment is provided for illustrative purposes and is merely an example, not the only way to implement these principles. Accordingly, references to elements, structures, or features in the drawings should be recognized as references to examples of embodiments of this disclosure, and this disclosure should not be understood as limiting it to specific elements, structures, or features illustrated. Other examples of ways to implement the disclosed principles will be apparent 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 this disclosure without departing from the scope or spirit of the subject matter of the invention. For example, a feature illustrated or described as part of one embodiment can be used in conjunction with another embodiment to result in further embodiments. Therefore, the subject matter of the invention is intended to encompass modifications and variations that fall within the scope of the appended claims and their equivalents.

[0017] This disclosure will be understood to be described in various levels of detail in this application. In some cases, details that are not necessary for a person skilled in the art to understand this disclosure, or details that would make it difficult to recognize other details, may be omitted. The terms used herein are for the sole purpose of describing specific embodiments and are not intended to limit them beyond the scope of the appended claims. Unless otherwise defined, the technical terms used herein should be understood as commonly understood by a person skilled in the art to which this disclosure belongs. All devices and / or methods disclosed and claimed herein can be fabricated and performed without undue experimentation in light of this disclosure.

[0018] As used herein, “proximal” means the direction or location closest to the user (such as a healthcare professional or clinician or technician or operator or physician; such terms are used interchangeably herein and are not intended to be limiting, and include automated control systems, etc.), such as when the device is used (e.g., when the device is introduced, implanted, positioned, or delivered to a patient) and / or closest to the delivery device; “distal” means the direction or location furthest from the user, such as when the device is used (e.g., when the device is introduced, implanted, positioned, or delivered to a patient) and / or closest to the delivery device; “longitudinal” means extending along the longer or greater dimension of an element; “central” means at least approximately bisecting the center point and / or being approximately equidistant from the outer periphery or boundary; “central axis” means, with respect to an opening, the line that at least approximately bisecting the center point of the opening and, if the opening includes, for example, a tubular element, channel, cavity, or hole, extends longitudinally along the length of the opening. As used herein, the “free end” of an element is the end beyond which such an element does not extend.

[0019] This disclosure relates to various devices, systems, and methods for applying traction to tissues within the body. Some medical procedures, including those performed along the gastrointestinal tract and / or bile ducts, utilize medical devices to access tissues intended for removal within the body (e.g., “target tissue”). 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 to access and remove lesions. Endoscopes can allow access to the target tissue site (the site where the target tissue is located) and can also allow various tissue manipulation devices to be deployed through them. Such tissue manipulation devices include, but are not limited to, devices for excising target tissue, and cutting devices, such as knives, scalpels, scissors, electrocautery devices, end effectors, grippers, snares, forceps, dissection instruments, energy-based tissue coagulators or cutters, clamps, tissue staplers, tissue loops, clip applicators, suture delivery devices, etc., and specific devices are not important to this disclosure. It will be understood that terms such as medical tools, instruments, and devices are not intended to be limiting and may be used interchangeably herein. In addition, in some cases, endoscopes may incorporate features that assist medical professionals in visualizing and / or imaging tissue dissection / excision procedures, for example, to facilitate the performance of the procedure. For example, some endoscopes may include light and / or cameras designed to illuminate and / or visualize the treatment site / target tissue area as the endoscope is navigated and positioned adjacent to the target tissue site. In addition, some endoscopes may also include a lumen (e.g., a working channel) through which further instruments, and optionally a delivery sheath for the instruments, may be deployed and utilized. Further visualization methods (e.g., fluoroscopy) may be employed alternatively or incidentally.In this specification, for convenience, tissue resection (and other grammatical forms of tissue resection) is referred to, and such terms are understood to include, without intention of limitation, tissue incision, cutting, manipulation, etc. (and other grammatical forms thereof).

[0020] Physicians are becoming more proficient in removing lesions from within the body (such as the digestive tract, abdominal cavity, thoracic cavity, etc.), but the current traction methods may continue to be inefficient for physicians. For example, in some cases, if visualization is insufficient and the ability to engage and manipulate the tissue is insufficient, the time for the tissue incision procedure may be prolonged. There may also be cases where it is desirable to lift the tissue, retract it out of the field of view, or not interfere with the instruments used to perform the procedure. For example, in some parts of EMR / ESD procedures, physicians may use separate devices to provide means of tissue traction, such as moving the tissue relative to the surrounding tissue. Positioning and manipulation (such as traction) of the resected tissue flap during and after resection present various challenges. Such procedures may involve multiple device operations and / or exchanges, as well as an associated extension of the procedure time. Such systems may be unable to maintain or adjust the traction force or tension applied to the target tissue, and / or the traction force or tension applied to the target tissue may be maintained or adjusted in an inefficient or inconsistent manner.

[0021] In accordance with the various principles of this disclosure, tissue traction devices are used to impart traction to tissue to facilitate the performance of procedures on such tissue. A tissue traction device (which may, for convenience and not limit, be referred to alternately with a tether) may be a traction band, elastic band, stretchable elongated member, wire, cord, cable, spring, suture, and / or optionally any other suitable stretchable and / or elongable member. While a tether may be advantageously elastic and / or elastomer (e.g., formed of rubber), it will be understood that elasticity and / or stretchability are not necessarily embodiments of traction devices formed in accordance with the various principles of this disclosure.

[0022] The tissue traction device may engage with tissue at a target tissue site using a tissue engagement member, which may, alternatively, be referred to herein, without limitation, as a tissue fastener or clip or other mechanical fastening device (e.g., hemostatic clip, clamp, gripper, basket, gripper, magnet, adhesive, etc.). The reference “at” the target tissue site is intended to include, and not limited to, the tissue at the target tissue and the surrounding tissue. Terms such as engage (and other grammatical forms of engage) may, without limitation herein, be used interchangeably with terms such as connect, grasp, hold, fasten, clip, secure, attach, attach, fix, etc. (and other grammatical forms thereof). The tissue engagement member may optionally be formed separately from the tissue traction device. In some embodiments, the tissue engagement member is repositionable after being partially deployed. For example, a tissue engagement member may be configured such that, in a first configuration, it is releasably engaged with tissue (e.g., closed to engage but not locked), and in a second closed configuration, it is locked so as not to disengage from tissue and become open. In some embodiments, the tissue engagement member has gripping arms or jaws that are selectively movable away from each other to engage tissue between them, and movable toward each other to grip the engaged tissue. The gripping arms may be hinged together (e.g., as a single piece) or may be movable toward each other by being separately formed and pivotable about a pivot point. The gripping arms may have one or more further gripping features, such as serrated or crenate contours or teeth, at the ends and / or along the edges of the gripping arms. In some embodiments, the tissue engagement member is movable relative to a tissue traction device, even when connected to a tissue traction device. Movement of the tissue engagement member, such as rotation (e.g., 360° rotation), can be controlled by a proximal control knob, dongle, or other actuator element.In some embodiments, the tissue engagement member may be operable, for example rotated, in a one-to-one correspondence between movement of the control knob and movement of the tissue engagement member. In some embodiments, the tissue engagement member is releasable from a delivery device used to deliver the tissue engagement member. For example, a fragile connection between the tissue engagement 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 engagement member. In some embodiments, the tissue traction device is delivered to the target tissue site together with the tissue engagement member coupled thereto.

[0023] In accordance with various principles of this disclosure, a tissue traction device has a target tissue engagement section or segment configured and positioned to engage with tissue at a target tissue site. Such engagement of the target tissue engagement segment with tissue may be direct or indirect and may involve, for example, the use of an initial or first tissue engagement member (optionally pre-loaded into the tissue traction device prior to delivery to the target tissue site, or otherwise coupled). For convenience, and not intended to limit, the tissue first engaged by the tissue traction device is referred to herein as the target tissue, but tissue other than the target tissue may be engaged first instead. Another section of the tissue traction device is then engaged with tissue separated from the target tissue (referred to herein, but not intended to limit, as the first traction tissue site) in a manner that allows the tissue traction device to impart traction force to the target tissue. A second tissue engagement member may be used to engage the traction tissue engagement section of the tissue traction device with the traction tissue site. As the target tissue is moved relative to the surrounding tissue (e.g., cut relative to the surrounding tissue), the traction force applied to it by the tissue traction device may decrease. In accordance with various principles of this disclosure, instead of increasing tension on the target tissue by moving the traction tissue engagement section of the tissue traction device to a different location, one or more additional traction tissue engagement sections of the tissue traction device may engage with the traction tissue and increase the traction force applied to the target tissue site. It should be understood that the additional traction tissue engagement sections of the tissue traction device may engage at essentially the same traction tissue site (depending on the size, shape, configuration, and / or location of the various traction tissue engagement sections) or at different traction tissue sites (such as becoming increasingly farther from the target tissue). For example, if the distances between the target tissue and the various traction tissue engagement sections of the tissue traction device are different, different traction force vectors may be applied by different traction tissue engagement segments, even if they are engaged at a common traction tissue site.

[0024] In accordance with various principles of this disclosure, tissue traction devices are molded to allow for different attachment points to tissue, such as by the use of tissue engagement members. For example, in some embodiments, tissue traction devices formed in accordance with various principles of this disclosure have two or more gripping sections or segments that are different from another gripping section or segment. The terms section, segment, area, or part may be used interchangeably herein without intent to limit, and it will be understood that a gripping segment of a tissue traction device is referred to as a section different from another section of the tissue traction device. Different sections of a tissue traction device may be distinguished from each other by differences in shape or orientation relative to another gripping segment of the tissue traction device (for example, being adjacent or adjoining to a gripping segment), etc., and may be defined along the section of the tissue traction device as different gripping segments.

[0025] In one embodiment, a tissue traction device may be formed according to various principles of this disclosure, comprising an outer or peripheral section defining one or more gripping segments along it, and one or more gripping segments defined within the periphery of the outer or peripheral section. The gripping segments defined along or within the peripheral section of the tissue traction device may engage with target tissue to which a traction force is applied, and may be referred herein to as target tissue engaging segments. One or more of the gripping segments defined along or within the peripheral section of the tissue traction device may engage with traction tissue located away from the target tissue, thereby applying a traction force to the target tissue. Such segments may be referred herein to as traction-tissue-engaging segments. According to various principles of this disclosure, the traction-tissue-engaging segments may be located at progressively further distances from the traction tissue and / or progressively shorter distances from the target tissue, so that engagement of different such traction-tissue-engaging segments to substantially the same traction tissue site alters the force vector of the traction force applied by the tissue traction device. Accordingly, tissue traction devices formed according to the various principles of this disclosure provide multiple gripping segments or holding locations for a medical professional to grasp, manipulate, and / or engage the tissue traction device with a selected area of ​​tissue separated from the target tissue, thereby changing the force vector of traction applied to the target tissue and thereby improving the usefulness of the tissue traction device.

[0026] In some embodiments, the tissue traction device has an outer perimeter section in the form of loops. In some embodiments, one or more further sections, such as further loops, are formed within the outer perimeter section. For example, in some embodiments, each of the further loops is located within another loop. In other words, the loops are nested within each other. In some embodiments, the nested loops are generally connected to each other so that all the loops together form the tissue traction device as a whole (a unified element in a single piece, rather than as separate loops). In some embodiments, the loops are inwardly connected along a common section of the tissue traction device. For example, in some embodiments, all connected nested loops are connected in a common section of the tissue traction device, such as along the target tissue engagement segment of the tissue traction device. Thus, as each of the smaller loops within the outermost loop (e.g., the outer perimeter section of the tissue traction device) is extended to engage with the traction tissue away from the target tissue, an increasing amount of traction force may be applied to the target tissue. A medical professional may have a sense of the difference in the traction force applied by comparing the relative sizes of the inner loops being grasped to engage with the traction tissue. Furthermore, if each of the nested loops within the outer perimeter section of the tissue traction device is coupled to the outer perimeter section within the overall area of ​​the target tissue engagement segment, the traction force imparted by engaging the traction tissue with one of the nested loops is generally imparted more directly to the target tissue than if the nested loop were coupled to a different area of ​​the outer perimeter section, and the traction force vector may be modified as desired by the user.

[0027] Tissue traction devices formed according to the various principles of this disclosure enable medical professionals to change the force vector applied to a target tissue in order to impart traction to the target tissue. For example, engaging a first segment of a tissue traction device with a first region of tissue (including, but not limited to, target tissue), and then engaging different segments of the tissue traction device with different regions of tissue separated from the first region of tissue (sequentially or simultaneously), enables the application of varying degrees or intensities and / or angles of traction to the target tissue. If a medical professional needs to engage a target tissue engagement segment of a tissue traction device with a target tissue site, and then engage a traction tissue engagement segment of a tissue traction device with a traction tissue site, and then adjust the traction on the target tissue site (e.g., to apply a further, greater traction force to the target tissue site, or to apply a traction force at a different angle), then a further traction tissue engagement segment of the tissue traction device may be engaged with the traction tissue, or with further traction tissue sites separated from the traction tissue, to apply a greater amount of traction force and / or traction force at a different angle to the target tissue.

[0028] In some embodiments, in order to engage two or more traction tissue engagement segments of a tissue traction device with substantially the same traction tissue, the tissue engagement member is configured to be engageable with two or more segments of the tissue traction device according to various principles of the Disclosure. In some embodiments, the traction device hanger is formed on a portion of the tissue engagement member and is sized, molded, configured, and / or dimensional to receive two or more segments of a tissue traction device formed according to various principles of the Disclosure with a plurality of traction tissue engagement segments.

[0029] In some embodiments, a tissue traction device formed according to various principles of the present disclosure (such as having two or more traction tissue engagement segments) includes a traction device hanger which is sized, molded, configured, and / or dimensionally determined to receive two or more traction tissue engagement segments of the tissue traction device. In such embodiments, the size / degree of the tissue traction device is modified by coupling one or more traction tissue engagement segments to the hanger so as to vary the traction force applied to the traction tissue with which the tissue traction device is engaged.

[0030] Various embodiments of tissue traction devices, systems, and methods of use thereof will be described herein with reference to the examples shown in the accompanying drawings. References in this specification to “one embodiment,” “one embodiment,” “several embodiments,” and “other embodiments” indicate that one or more specific features, structures, and / or properties in accordance with the principles of this disclosure may be included in relation to an embodiment. However, such references do not necessarily mean that all embodiments include a particular feature, structure, and / or property, or that an embodiment includes all features, structures, and / or properties. Some embodiments may include one or more such features, structures, and / or properties in various combinations thereof. Furthermore, references to “one embodiment,” “one embodiment,” “several embodiments,” and “other embodiments” in various parts of this specification do not necessarily all refer to the same embodiment, and separate or alternative embodiments do not necessarily exclude other embodiments from each other. Where a particular feature, structure, and / or property is described in relation to one embodiment, it should be understood that such feature, structure, and / or property may be used in relation to other embodiments, whether explicitly described or not, unless the opposite is explicitly stated. It should be further understood that such features, structures, and / or characteristics may be used or present, alone or in various combinations with each other, to create alternative embodiments that are considered part of this disclosure, because describing all the numerous possible combinations and partial combinations of such features, structures, and / or characteristics would be extremely cumbersome. Furthermore, various features, structures, and / or characteristics that may be shown by some embodiments but not by others are described. Similarly, various features, structures, and / or characteristics or requirements that may be features, structures, and / or characteristics or requirements for some embodiments but not for others are described.Therefore, this disclosure is not limited to the embodiments specifically described herein, and the examples of embodiments disclosed herein are not intended to limit the broader aspects of this disclosure.

[0031] In the embodiments shown in the drawings, common features are identified by common reference elements, and for brevity and convenience, it will be understood that descriptions of common features are generally not repeated, without the intention of limitation. 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 referenced when appearing in different embodiments.

[0032] Referring here to Figures 1 and 2, examples of the use of the tissue traction device 100 in accordance with the various principles of this disclosure are shown. An example of an embodiment of the tissue traction device 100, formed in accordance with the various principles of this disclosure and usable as shown in Figures 1 and 2, is shown in Figure 3. The tissue traction device 100 has a target tissue engaging end 101 that engages with the target tissue TA at the target tissue site TS (directly or indirectly, such as by the use of a tissue engaging member 200, which will be described in more detail below), and a traction tissue engaging end 103 that engages with the traction tissue TR1 separated from the target tissue TA (directly or indirectly, such as by the use of a tissue engaging member 200). When engaged in this manner, the tissue traction device 100 imparts traction to the target tissue TA. The reference to the first or second end of the tissue traction device is for simplification purposes and should not be understood as being limited to, but not limited to, the ends of elongated elements, but should be understood as being applicable to other locations along elements such as elongated elements.

[0033] As can be understood by referring to Figure 3, illustrated examples of embodiments of tissue traction devices 100 formed according to various principles of this disclosure have an outer perimeter section 110 with one or more further traction sections 120, 130. The outer perimeter section 110 is generally a loop shape, such as a closed shape such as a circular or elliptical shape, but other shapes are also within the scope and spirit of this disclosure. The outer perimeter section 110 includes a target tissue engagement segment 112 along the target tissue engagement end 101 of the tissue traction device 100 and a traction tissue engagement segment 114 located away from the target tissue engagement segment 112. In the use examples shown in Figures 1 and 2, the target tissue engagement segment 112 engages with the target tissue TA, and the traction tissue engagement segment 114 engages with the traction tissue TR1. Other orientations and configurations are also within the scope of this disclosure, and it should be understood that the specific locations along the tissue traction device 100 that engage with the target tissue TA and the traction tissue TR1 are not limited to those illustrated and shown in the drawings. Further traction sections 120, 130 may be defined relative to the outer perimeter section 110, such as within the perimeter defined by the outer perimeter section 110. As will be described in more detail below, further traction sections 120, 130 may extend to tissues separated from the target tissue area TA, such as traction tissue TR1 or traction tissue TR2, as shown in Figure 2. As can be understood, further traction forces on the target tissue TA lift the target tissue TA further away from the surrounding tissue, allowing procedures 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 engagement member 200 is used to engage a target tissue engagement segment 112 with a target tissue TA. Alternatively, or incidentally, a tissue engagement member 202 is used to engage a traction tissue engagement segment 114 of a tissue traction device 100 with a traction tissue TR1. In the examples of embodiments shown in Figures 1 and 2, the tissue engagement members 200, 202 are adjustable clips (such as hemostatic clips) having first and second gripping arms 210 (which may be referred to herein alternatively as jaws, without intent to limit) that are movable relative to each other between an open configuration and a closed configuration. In the open configuration, tissue may be positioned between the gripping arms 210 so as to be engaged by the gripping arms 210. In the closed configuration, the gripping arms 210 engage or hold the tissue between them. In some embodiments, the tissue engagement member 200 includes a capsule 220 from which the proximal end of a gripping arm 210 can be retracted to move the tissue engagement member 200 into a closed configuration, and from which the gripping arm 210 can be extended to move the tissue engagement member 200 into an open configuration. A controller (not shown, whose configuration is known to those skilled in the art and does not form part of the disclosure) may be operably coupled to the gripping arm 210 to actuate the movement of the gripping arm 210 between the open and closed configurations (e.g., relative to the capsule 220). The controller may be detachable from the tissue engagement member 200 once a desired position and / or configuration of the tissue engagement member 200 is achieved or reached. The gripping arm 210 may be locked in place relative to the capsule 220 once a desired position, configuration, etc. of the gripping arm 210 is achieved by any of the various mechanisms known to those skilled in the art, and the disclosure is not limited to such configurations or features. The tissue engagement member 200 may be configured to engage with tissue, as well as with the target tissue engagement segment 112 and / or traction tissue engagement segment 114 of the tissue traction device 100. Therefore, the target tissue engagement segment 112 and / or traction tissue engagement segment 114 of the tissue traction device 100 do not need to engage directly with the tissue, but may engage with the tissue via the tissue engagement member 200.

[0035] As shown in Figures 1 and 2, the endoscope 300 delivers 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 traction 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 applied by the tissue traction device 100 is relieved. As shown in Figure 2, to increase the traction force on the target tissue TA, an additional traction section 120 is extended to an additional traction tissue TR2 separated from the traction tissue TR1 to which the traction tissue engagement segment 114 is engaged (as shown in Figure 2), or to the same target tissue TT1 to which the traction tissue engagement segment 114 is engaged (as shown in Figures 4, 5, 6, and 7, as will be discussed in more detail below). The additional traction section 120 may engage with additional traction tissues TT1, TT2 along the traction tissue engagement segment 124 along the additional traction section 120. Such a traction tissue engagement segment 124 is shown in Figure 3 along the traction tissue engagement end 103 of the tissue traction device 100, but the traction tissue engagement segments 124 of the further traction section 120 may be located at other positions along the further traction section 120. It should be understood that a tissue manipulation device 400 or another device (e.g., an end effector, hook, gripper, etc.) may be used to engage the further traction sections 120, 130 of the tissue traction device 100 with the traction tissue.

[0036] In an example of one embodiment of the tissue traction device 100 illustrated in Figure 3, the further traction sections 120, 130 are in the form of loops, one positioned within the other and coupled to / extending from a target tissue engagement segment 112 of the outer periphery section 110 of the tissue traction device 100. The further traction sections 120, 130 are connected to the outer periphery section 110 along their target tissue engagement segments 112 to, for example, direct traction towards target tissue, optimize the distance the further traction sections extend from target tissue to target tissue, generate a substantially linear force vector applied between the traction tissue and the target tissue, and can change the force vector (e.g., magnitude and / or direction). The tissue traction device 100 formed according to various principles of this disclosure may have further internal traction sections within the illustrated further traction sections 120, 130, and this disclosure is not limited to a specific number of further traction sections. Each of the additional traction sections may be engaged (directly or indirectly) with additional traction tissue, so as to be progressively separated from the traction tissue to which the traction section of the tissue traction device 100 is already engaged, or may be engaged with the same traction tissue site in general to impart a greater traction force to the target tissue and / or to adjust the angle of traction applied to the target tissue.

[0037] It will be understood that tissue traction devices formed according to the various principles of this disclosure allow medical professionals to change the force vector of traction applied to a target tissue by engaging one or more segments of the tissue traction device with the traction tissue (at the same site or at spaced sites), thereby facilitating the performance of any of the various procedures on or around the target tissue. For example, as the target tissue is excised or incised, or otherwise moved relative to the surrounding tissue at the site of the target tissue, the traction force applied by the tissue traction device may be reduced. To maintain a constant amount of traction on the target tissue, instead of moving the initial traction tissue engagement segment of the tissue traction device (as in the procedures of the prior art), one or more further traction tissue engagement segments of the tissue traction device may engage with the traction tissue (simultaneously and / or sequentially). The traction tissue portions may be spaced apart from one another, as shown in Figures 1 and 2, but further traction sections 120, 130 (etc.) of the tissue traction device 100, formed according to various principles of this disclosure, may instead engage with all the traction 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 understood that engaging two or more segments or sections of a tissue traction device with tissue in substantially the same area or location can present various challenges. For example, when different tissue engagement members are used, generally a limited number of tissue engagement members can engage with tissue at a particular tissue site. When the same tissue engagement member is used to engage one or more segments or sections of a tissue traction device with tissue, there is a risk that one or more segments or sections of the tissue traction device may inadvertently detach from the tissue engagement member. For example, a tissue engagement member in the form of a clip with a gripping arm that can shift between an open and closed configuration may lose its grip on a segment or section of the tissue traction device while engaging with or attempting to maintain engagement with another segment or section of the tissue traction device.

[0039] To facilitate the engagement of two or more traction tissue engagement segments or sections of a tissue traction device to a common traction tissue site (approximately the same location, substantially spaced from the target tissue to which the tissue traction device is first engaged), modified tissue engagement members may be used for all traction tissue engagement segments or sections that engage to the common traction tissue site. Examples of embodiments of modified tissue engagement members 1200 formed according to various principles of this disclosure are shown in Figures 4, 5, and 6. According to various principles of this disclosure, the modified tissue engagement member 1200 is configured to engage with two or more segments or sections of a tissue traction device 100 (such as one formed according to various principles of this disclosure, or another tissue traction device) by engaging at least one segment or section of the tissue traction device 100 with the gripping arm 1210 of the tissue engagement member 1200, and engaging one or more other segments or sections of the tissue engagement member 1200 with another structure of the tissue engagement member 1200, etc. For example, in the embodiments shown in Figures 4, 5, and 6, the modified tissue engagement member 1200 has a modified capsule 1220 configured to engage with one or more other segments or sections of the tissue engagement member 1200. The modified capsule 1220 may include a hanger 1230, which is formed integrally with the capsule 1220 or separately formed and coupled thereto. The hanger 1230 is sized, molded, configured, and / or dimensionally determined to engage with one or more segments or sections of the tissue traction device and to engage and hold such segments or sections with the tissue engagement member 1200. For example, the hanger 1230 may include an arm 1232 extending away from the capsule 1220 (e.g., substantially laterally with respect to the capsule wall) and a hook 1234 extending laterally with respect to the arm 1232, as can be understood by referring to Figure 4. The arms 1232 and hooks 1234 may be sized to engage with the hanger 1230 and hold two or more sections or segments of the tissue traction device 100 against the tissue engagement member 1200.The hook 1234 may be sized, molded, constructed, and / or dimensional relative to the arm 1232, etc., to hold two or more sections or segments of the tissue traction device 100 that engages with the arm 1232. It will be understood that configurations of hangers other than the illustrated hanger 1230 are within the scope and spirit of this disclosure.

[0040] As shown in Figure 4, the target tissue engagement segment 112 of the tissue traction device 100 may engage with the target tissue TA (optionally, with the use of the tissue engagement member 200 as described above), and the traction tissue engagement segment 114 of the tissue traction device 100 may engage with the traction tissue TR using the modified tissue engagement 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 (such as an end effector, hook, gripper, or tissue manipulation device 400 used on the target tissue TA, as shown in Figure 1 or 2) may engage another section or segment of the tissue traction device 100 with the modified tissue engagement member 1200, for example, by hooking one or more of the further traction sections 120, 130 of the tissue traction device 100 onto the hanger 1230. In the example shown in Figure 5, the further traction section 120 is engaged with the hanger 1230. However, it should be understood that another further towing section, such as a smaller further towing section 130, may be engaged with the hanger 1230 in front of, behind, or instead of the illustrated further towing section 120. For example, two or more further towing sections 120, 130 may be engaged with the hanger 1230, as shown in Figure 6.

[0041] Instead of engaging further sections or segments of the tissue traction device with the same tissue engagement member and engaging such further sections or segments with substantially the same traction tissue TR, the further sections or segments may engage with structures on the modified tissue traction device 1100, as shown in Figure 7. More specifically, an example of an embodiment of the modified tissue engagement member 1200 shown in Figure 7 includes a hanger 1150 which is formed integrally with or separately formed and coupled to the outer peripheral section 1110 of the modified tissue traction device 1100. The hanger 1150 is sized, molded, configured, and / or dimensionally determined for engagement of two or more segments or sections of the modified tissue traction device 1110 with its own, and for engaging with the hanger 1150 to hold such segments or sections. For example, the hanger 1150 may include one or more arms 1152 having one or more hooks 1154 extending laterally with respect to the arms 1152. The arms 1152 and hooks 1154 may be sized to engage with and hold two or more sections or segments of the modified tissue traction device 1100 in the hanger 1150. The hooks 1154 may be sized, molded, constructed, and / or dimensional relative to the arms 1152, etc., to engage with and hold two or more sections or segments of the modified tissue traction device 1100 in the arms 1152, etc. Other configurations of hangers other than the illustrated hanger 1150 will be understood to be within the scope and spirit of this disclosure.

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

[0043] As described above, segments of a tissue traction device formed according to the various principles of this disclosure may engage with an initial tissue site (referred to as, for convenience, the target tissue, without limitation) using tissue engagement members (optionally pre-loaded onto the tissue traction device), and then another segment of the tissue traction device may engage with another region of tissue (referred to herein, for convenience, the traction tissue and / or traction tissue site, without limitation), thereby applying traction force to the target tissue via the tissue traction device. The target tissue site may be located within a body passage or lumen (including, but not limited to, the gastrointestinal tract such as the small or large intestine), and the traction tissue may be along the wall of the body passage or lumen opposite the target tissue. Naturally, it will be understood that devices, systems, and methods according to the various principles of this disclosure may be used in connection with other anatomical regions and / or structures. Embodiments of this disclosure may be described with specific reference to medical devices and systems and procedures for treating the gastrointestinal system, but it should be understood that such medical devices and methods may be used to treat tissues such as the abdominal cavity, digestive system, urinary tract, reproductive tract, respiratory system, cardiovascular system, and circulatory system.

[0044] All apparatus and methods described herein are examples of apparatus and / or methods that are carried out in accordance with one or more principles of this disclosure. These examples are merely examples and not the only ways of carrying out these principles, and are not intended to limit the broader aspects of this disclosure. Accordingly, references to elements, structures or features in the drawings should be recognized as references to embodiments of the embodiments of this disclosure, and this disclosure should not be understood as limiting to the specific elements, structures or features illustrated. Other examples of ways of carrying out the disclosed principles will be conceivable to those skilled in the art by reading this disclosure. Embodiments of this disclosure may be described with specific reference to medical devices and systems and procedures for treating the gastrointestinal system, but it should be understood that such medical devices and methods may be used to treat tissues such as the abdominal cavity, digestive system, urinary tract, reproductive tract, respiratory system, cardiovascular system, and circulatory system.

[0045] The preceding discussions are presented for illustrative and explanatory purposes and have broad applicability, and are not intended to limit the 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 concepts, spirit, and scope of the disclosure. In particular, it will be apparent to those skilled in the art that the principles of the disclosure may be embodied in other forms, structures, arrangements, proportions, and using other elements, materials, and components without departing from the concepts, spirit, scope, or features thereof. For example, various features of the disclosure have been combined into 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 disclosure may be combined in alternative aspects, embodiments, or configurations. While the disclosure is presented with respect to embodiments, it should be understood that various distinct features of the subject matter of the application do not all need to be present in order to achieve at least some of the desired properties and / or advantages of the subject matter or such individual features. Those skilled in the art will understand that this disclosure can be used with many changes or modifications to the structure, arrangement, proportions, materials, components, and other elements used in the implementation of this disclosure, without departing from the principles, spirit, or scope of this disclosure, to be particularly suited to specific environmental and operating requirements. For example, an element shown as integrally formed may consist of multiple parts, an element shown as multiple parts may be integrally formed, the operation of an element may be reversed or otherwise modified, and the size or dimensions of an element may be changed. Similarly, while an operation or action or procedure is described in a particular order, this should not be understood as requiring such a particular order to achieve a desired result, or as meaning that all operations or actions or procedures should be performed. Furthermore, other forms of implementation are within the scope of the following claims. In some cases, the actions described in the claims may be performed in a different order and still achieve the desired result.Accordingly, the embodiments disclosed herein should be considered in all respects as illustrative and not limiting, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the foregoing description or specific embodiments or configurations described or illustrated herein. In view of the foregoing, 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.

[0046] In the foregoing description and the following claims, it will be understood that: The phrases “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,” and “second” do not exclude plurals. For example, the term “a” or “an” entity, as used herein, refers to one or more of those entities. Thus, the terms “a” (or “an”), “one or more,” and “at least one” can be used interchangeably herein. References to all directions (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, up, down, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or similar) are used solely for identification purposes to aid the reader's understanding of this disclosure and / or to distinguish areas of related elements from one another, and do not limit the elements relevant in particular with respect to the position, orientation, or use of this disclosure. References to connections (e.g., attached, joined, connected, engaged, and joined) should be interpreted broadly and, unless otherwise indicated, may include intermediate members between sets of elements and relative motion between elements. Thus, references to connections do not necessarily mean that two elements are directly connected and in a fixed relationship with respect to one another. Identifying references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority and are used to distinguish one feature from another.

[0047] The following claims are incorporated into this detailed description by this reference, and each claim stands alone as a distinct embodiment of the present disclosure. In the claims, the term “comprises / comprising” does not preclude the presence of other elements, components, features, regions, integers, steps, operations, etc. In addition, individual features may be included in different claims, but they may be advantageously combined in some cases, and inclusion in different claims does not mean that the combination of features is not feasible and / or unfavorable. In addition, a singular reference does not preclude plurals. Reference numerals in the claims are provided merely as examples for clarity and should never be construed as limiting the claims.

Claims

1. It is an organizational leadership system. A tissue traction device comprising: a target tissue engagement segment capable of engaging with target tissue; and at least two traction tissue engagement segments separated from the target tissue engagement segment and capable of engaging with traction tissue; A tissue engagement member configured to engage at least one traction tissue engagement segment with the traction tissue, A hanger configured to hold at least one traction tissue engagement segment adjacent to the traction tissue, An organizational leadership system equipped with these features.

2. The tissue traction system according to claim 1, wherein the tissue traction device comprises an outer peripheral section defining the periphery, and the at least one traction tissue engagement segment is provided within the periphery of the outer peripheral section of the tissue traction device.

3. The tissue traction system according to claim 2, wherein the target tissue engagement segment is defined along the outer peripheral section.

4. The aforementioned outer perimeter section is in the form of a loop, and The tissue traction system according to any one of claims 1 to 3, wherein the at least one traction tissue engagement segment in the outer peripheral section is defined on a loop-shaped traction tissue engagement section in the outer peripheral section.

5. The target tissue engagement segment is defined along the outer periphery section, and The tissue traction system according to claim 4, wherein the loop-shaped traction tissue engagement section within the outer peripheral section is in contact with the outer peripheral section adjacent to the target tissue engagement segment on the inside.

6. The tissue traction system according to any one of claims 1 to 5, further comprising a further traction tissue engagement segment within the outer peripheral section.

7. The tissue traction system according to claim 6, wherein the further traction tissue engagement segments are defined on further loop-shaped traction tissue engagement sections within the outer peripheral section.

8. The target tissue engagement segment is defined along the outer periphery section, The further loop-shaped traction tissue engagement section is located within the loop-shaped traction tissue engagement section, and The tissue traction system according to claim 6 or 7, wherein the outer peripheral section, the loop-shaped traction tissue engagement section, and the further loop-shaped traction tissue engagement section are adjacent to and in contact with the target tissue engagement segment on the inside.

9. The tissue traction system according to any one of claims 1 to 8, wherein the hanger is located on the tissue engagement member or the tissue traction device.

10. It is an organizational traction device: An outer peripheral section defining the periphery of the tissue traction device, A first traction structure engagement section extends within the periphery of the outer periphery section and is coupled to the outer periphery section, An organizational traction device equipped with the following features.

11. The aforementioned outer peripheral section defines a target tissue engagement segment that can engage with target tissue, and The tissue traction device according to claim 10, wherein the first traction tissue engagement section defines at least one traction tissue engagement segment that is separated from the target tissue engagement segment and is capable of engaging with traction tissue.

12. The outer peripheral section and the first traction structure engagement section are each in the form of a loop, and The tissue traction device according to claim 10 or 11, wherein the first traction tissue engagement section is inwardly in contact with the outer peripheral section adjacent to the target tissue engagement segment.

13. The tissue traction device according to any one of claims 10 to 12, further comprising a second traction tissue engagement section within the outer peripheral section.

14. The tissue traction device according to claim 13, wherein the second traction tissue engagement section is located within the first traction tissue engagement section.

15. The outer peripheral section defines a target tissue engagement segment that can engage with target tissue, and a traction tissue engagement segment that is separated from the target tissue engagement segment and can engage with traction tissue, and The tissue traction device according to claim 10, further comprising a hanger configured to hold the traction tissue engagement segment of the first traction tissue engagement section adjacent to the traction tissue on the outer peripheral section adjacent to the traction tissue engagement segment.

Images