Stabilization and leverage devices, systems and methods

Abstract

To provide tissue stabilization and leverage devices, methods, and related systems.SOLUTION: A stabilizer is configured to engage and stabilize a target tissue site, so that a procedure may be performed on a target tissue independently of the stabilizer. A lever is associated with the stabilizer and coupled with the target tissue to leverage the target tissue. In some embodiments, the stabilizer is deployed proximally to the target tissue site, and the lever proximal to the target tissue site and proximal to a distal end of a delivery device is used to deploy the stabilization and leverage device. In such an embodiment, the lever includes a lever component which may extend through a passage in the stabilizer to be controlled at a proximal end of the delivery device.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present disclosure relates generally to the field of medical instruments and devices. More specifically, the present disclosure relates to medical instruments and devices for use in medical applications, such as for manipulating body tissue during procedures on the tissue, such as resection or incision. [Background technology]

[0002] Some medical procedures utilize medical devices or tools within the body (inside the digestive tract, abdominal cavity, bile duct, thoracic cavity, etc.) to access tissue intended for removal (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)), a physician or clinician (used interchangeably herein) may access and remove a diseased lesion by utilizing an endoscope or similar medical device.

[0003] With regard to endoscopic procedures, physicians are becoming increasingly willing to perform aggressive interventions and therapeutic procedures, such as for the removal of larger lesions (both cancerous and non-cancerous). Although physicians have become more adept at resecting and dissecting diseased lesions from within the body (e.g., inside the digestive tract, abdominal cavity, thoracic cavity, etc.), and specialized tools allow physicians to perform these complex procedures faster and easier, there are still some challenges. Such procedures may involve multiple device exchanges. Endoscopes provide little working space and stabilization for multiple tools to operate simultaneously.

[0004] It is with these considerations in mind that the improvements in the tissue stabilization and leverage devices, systems, and related methods of use presented by the present disclosure may be useful. Summary of the Invention

[0005] This summary of the disclosure is provided to aid in understanding, and those skilled in the art will appreciate that each of the various aspects and features of the disclosure may be advantageously used 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. Thus, while the disclosure is presented in terms of aspects or embodiments, it should be understood that each aspect may be claimed separately or in combination with aspects and features of that or any other embodiment.

[0006] The present disclosure, in its various aspects, is directed generally to medical devices, and more specifically to tissue stabilization and leverage devices, methods, and associated systems. Embodiments according to the present disclosure, including those described herein, can reduce complications surrounding procedures performed on bodily tissue, such as visualization, procedure time, and procedure complexity. The systems, devices, and methods disclosed herein may be compatible with other devices, systems, and methods, such as those used with endoscopes. In some embodiments, such systems, devices, and methods may operate independently of an endoscope, such that when the endoscope is manipulated to perform a procedure on tissue (e.g., retract or cut tissue), the stabilization and leverage mechanism remains fixed and is not affected by the movement of the endoscope and tools used for the procedure. In some embodiments, the systems and devices disclosed herein may leverage and / or retract tissue independently of the movement of a delivery device and / or other tools used on the tissue.

[0007] In one aspect, a stabilization and leverage device is disclosed herein. The device may be configured for delivery to a target tissue at a target tissue site by a delivery device. In some aspects, the stabilization and leverage device includes a stabilizer configured to mount on the delivery device and a lever associated with the stabilizer that extends between the target tissue and the stabilizer to leverage the target tissue. The stabilizer contacts and stabilizes the target tissue independent of the distal end of the delivery device, allowing independent free movement of the delivery device and the instrument extending therethrough relative to the stabilizer and the target tissue. In some embodiments, the stabilizer may be configured to be mounted on the delivery device.

[0008] In some embodiments, the lever comprises one or more of a support elevator, a tensioner or controller, a lever tool, a redirection structure, a tissue retraction device. In some embodiments, the stabilizer passage extends from a proximal end to a distal end of the stabilizer, and the lever includes a lever component extending from a first end coupled to the target tissue, through the stabilizer passage, and from a proximal end of the delivery device to a controllable second end to leverage the target tissue. In some embodiments, the lever component may additionally include a lever tool extending through the stabilizer passage, and the lever may include a support elevator associated with the passage through the stabilizer and configured to support and leverage the lever tool, the support elevator comprising one of a flapper, a support and a lever controller coupled to the support, a working channel, or a secondary inflatable balloon.

[0009] In some aspects, the stabilizer is an expandable stabilizer and the lever includes a tensioner extending between the expandable stabilizer and the target tissue, such that expansion of the expandable stabilizer exerts a leverage effect on the lever and the target tissue.

[0010] In some embodiments, the stabilization and leverage device includes a stabilizer controller associated with the stabilizer to facilitate manipulation of the stabilizer from a proximal end of a delivery device, the lever comprising at least one of: a tether having a first end coupled to the target tissue and a second end coupled to the stabilizer controller; a tether extending from the first end coupled to the target tissue, through the stabilizer controller, to a second end accessible at the proximal end of the delivery device for manipulation of the tether to leverage the target tissue; and a tether extending from the first end coupled to the target tissue, through a redirection structure on the stabilizer controller, along the stabilizer controller, to a second end accessible at the proximal end of the delivery device for manipulation of the tether to leverage the target tissue.

[0011] In some aspects, the stabilizer has a delivery device interface that is shaped and configured to receive the distal end of the delivery device during deployment of the stabilization and leverage device with the delivery device to the target tissue site. Additionally, in some aspects, a lever may comprise a lever component that is loaded through the working channel of the delivery device and pre-loaded onto the proximal end of the stabilizer that is mounted onto the distal end of the delivery device. Additionally or alternatively, in some aspects, the stabilizer has a ring opening therethrough that is shaped and configured to permit passage of an instrument therethrough.

[0012] In another aspect, disclosed herein is a stabilization and leverage system configured for delivery to a target tissue site. In some embodiments, the system is configured for stabilization of the target tissue site and leverage of the target tissue at the target tissue site. In some aspects, the stabilization and leverage system includes a delivery device, a stabilizer configured to mount on the delivery device, and a lever associated with the stabilizer and extending between the target tissue and the stabilizer to leverage the target tissue. The stabilizer stabilizes the target tissue independently of the distal end of the delivery device and allows independent free movement of the delivery device and instruments extending therethrough relative to the stabilizer and the target tissue.

[0013] In some aspects, the stabilizer includes a stabilizer passage associated with the stabilizer, and the lever includes a lever component coupled from a proximal end of the delivery device through the stabilizer passage to a target tissue distal to the delivery device to provide leverage to the target tissue. Additionally or alternatively, in some aspects, the lever includes a support elevator associated with the stabilizer passage, the stabilizer passage configured to pass a tensioner therethrough for coupling with the target tissue, and the support elevator and stabilizer passage leverage the tensioner to provide leverage to the target tissue. Additionally or alternatively, in some aspects, the lever component includes a lever tool extending through the stabilizer passage, the lever includes a support elevator associated with a passage through the stabilizer, the support elevator comprising one of a flapper, a support and a lever controller coupled to the support, a working channel, or a secondary inflatable balloon, and the support elevator configured to support and leverage the lever tool.

[0014] In some aspects, the stabilizer is an expandable stabilizer having a stabilizer passage associated with the stabilizer, and the lever includes a tensioner extending between the expandable stabilizer and the target tissue, such that expansion of the expandable stabilizer exerts a leverage effect on the lever and the target tissue.

[0015] In some aspects, the stabilization and leverage device includes a stabilizer controller associated with the stabilizer to facilitate manipulation of the stabilizer from a proximal end of a delivery device, the lever comprising at least one of: a tether having a first end coupled to the target tissue and a second end coupled to the stabilizer controller; a tether extending from the first end coupled to the target tissue, through the stabilizer controller to a second end accessible at the proximal end of the delivery device for manipulation to leverage the target tissue; and a tether extending from the first end coupled to the target tissue, through a redirection structure on the stabilizer controller, along the stabilizer controller to a second end accessible at the proximal end of the delivery device for manipulation to leverage the target tissue. In some aspects, the stabilizer has a delivery device interface that is shaped and configured to receive the distal end of the delivery device during deployment of the stabilization and leverage device with the delivery device to the target tissue site. Additionally or alternatively, in some aspects, a lever comprises a lever component that is loaded through the working channel of the delivery device and pre-loaded onto the proximal end of the stabilizer that is mounted onto the distal end of the delivery device. Additionally or alternatively, the stabilizer has a ring opening therethrough that is shaped and configured to permit passage of an instrument therethrough.

[0016] In another aspect, disclosed herein are methods of stabilizing a target tissue site and leveraging a target tissue at a target tissue site. In some aspects, the methods include using a delivery device to deliver a stabilization and leverage device mounted on the delivery device, deploying the delivery device to stabilize the target tissue independent of a distal end of the delivery device and allowing independent free movement of the delivery device and an instrument extended therethrough relative to the stabilizer and the target tissue, and extending a lever between the target tissue and the stabilizer, associating the lever with the stabilizer, and levering the target tissue.

[0017] In some aspects, the method further includes deploying a stabilizer proximal to the target tissue site and proximal to the distal end of the delivery device, and extending a lever proximally from the target tissue site to the stabilizer and proximal to the distal end of the delivery device.

[0018] In some aspects, the method further includes controlling the stabilizer via a stabilizer controller extending from the stabilizer to a proximal end of the delivery device, deploying the stabilizer distal to the target tissue site and distal to the distal end of the delivery device, extending a lever proximally from the target tissue site to the stabilizer controller, and levering the lever using the stabilizer controller to leverage the target tissue.

[0019] These and other features and advantages of the present disclosure will become readily apparent from the following detailed description, the scope of the claimed invention being set forth in the appended claims. [Brief description of the drawings]

[0020] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The accompanying drawings are provided for illustrative purposes only, and the dimensions, positions, order, and relative sizes reflected in the figures within the drawings may vary. For example, devices may be enlarged so that details are discernible, but are intended to be reduced in relation to fitting, for example, within a delivery catheter or working channel of an endoscope. In the drawings, identical or nearly identical or equivalent elements are typically represented by the same reference character. For purposes of clarity and conciseness, not every element is labeled in every figure, and not every element of each embodiment is shown if illustration is not necessary to enable a person skilled in the art to understand the disclosure.

[0021] The detailed description will be better understood in conjunction with the accompanying drawings, in which like reference characters represent like elements, and in which: [Figure 1] 1 illustrates a stabilization and leverage device according to an aspect of the present disclosure. [Diagram 2] 2 illustrates a stabilization and leverage device according to an embodiment of the present disclosure, showing an alternative lever to that shown in FIG. [Diagram 3] 3 illustrates a stabilization and leverage device according to an embodiment of the present disclosure, showing an alternative lever to that shown in FIGS. 1 and 2. [Figure 4] 4 illustrates a stabilization and leverage device according to an embodiment of the present disclosure, showing an alternative lever to that shown in FIGS. 1-3. [Diagram 5] 4 illustrates a stabilization and leverage device according to an embodiment of the present disclosure, showing an alternative lever to that shown in FIGS. 1-3. [Figure 6]6 illustrates a stabilization and leverage device according to an embodiment of the present disclosure, showing an alternative lever to that shown in FIGS. 1-5. [Figure 7] 6 illustrates a stabilization and leverage device according to an embodiment of the present disclosure, showing an alternative lever to that shown in FIGS. 1-5. [Figure 8] 1 illustrates another stabilization and leverage device according to an aspect of the present disclosure. [Figure 9] 1 illustrates another stabilization and leverage device according to an aspect of the present disclosure. [Figure 10] 10 illustrates a stabilization and leverage device according to an embodiment of the present disclosure, showing an alternative stabilizer to that shown in FIGS. 8 and 9. [Figure 11] 10 illustrates a stabilization and leverage device according to an embodiment of the present disclosure, showing an alternative stabilizer to that shown in FIGS. 8 and 9. [Figure 12] 1 illustrates another stabilization and leverage device according to an aspect of the present disclosure. [Figure 13] 1 illustrates another stabilization and leverage device according to an aspect of the present disclosure. [Figure 14] 14 illustrates a stabilization and leverage device according to an embodiment of the present disclosure, showing an alternative stabilizer to that shown in FIGS. 12 and 13. [Figure 15] 14 illustrates a stabilization and leverage device according to an embodiment of the present disclosure, showing an alternative stabilizer to that shown in FIGS. 12 and 13. [Figure 16] 1 illustrates another stabilization and leverage device according to an aspect of the present disclosure. [Figure 17] 17A-17C are schematic diagrams illustrating movement of a delivery device independent of the stabilization and leverage device of FIG. [Figure 18] 16 and 17 illustrate stabilization and leverage devices, and further illustrate leverage devices according to some embodiments of the present disclosure. [Figure 19] 19 illustrates a stabilization and leverage device according to an embodiment of the present disclosure, showing an alternative lever to that shown in FIG. 18. [Figure 20] 19A-19C show a stabilization and leverage device according to an embodiment of the present disclosure, illustrating an alternative lever to those shown in FIGS. 18 and 19. [Figure 21] 1 illustrates another stabilization and leverage device according to an aspect of the present disclosure. [Figure 22] 22 illustrates the stabilization and leverage device as in FIG. 21 with the stabilizer and lever advanced to position tissue for stabilization and leverage. [Figure 23] 23 shows a stabilization and leverage system similar to that of FIGS. 21 and 22, but with a modified stabilizer shown in cross section. [Figure 24] 24 illustrates the stabilization and leverage device as in FIG. 23 with the stabilizers and levers advanced and positioned to stabilize and leverage tissue. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. It will be understood that the present disclosure is described in this application with various levels of detail. In certain instances, details that are not necessary for a person skilled in the art to understand the present disclosure or that make it difficult for them to appreciate other details may be omitted. 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. It will be understood that the claimed subject matter is not necessarily limited to the specific embodiments or configurations described or illustrated herein, and that the scope of the claimed invention is set forth in the appended claims.

[0023] As used herein, a "proximal end" refers to the end of a device or object closest to a user (such as a medical professional or clinician or technician or operator or physician, such terms being used interchangeably without any limitation or otherwise intended), such as when using the device (e.g., when introducing the device into a patient or during implantation, positioning, or delivery), and a "distal end" refers to the end of a device or object furthest from a user, such as when using the device (e.g., when introducing the device into a patient or during implantation, positioning, or delivery). A central axis, with respect to an opening, means a line that at least approximately bisects the center point of the opening and extends longitudinally along the length of the opening if the opening comprises, for example, a tubular frame, strut, or bore.

[0024] As used herein, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise.

[0025] Various embodiments of stabilization and leverage devices, systems, and methods are described herein. References herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," and the like indicate that one or more particular features, structures, and / or characteristics according to the principles of the present disclosure may be included in association with that embodiment. However, such references do not necessarily mean that all embodiments include the particular feature, structure, and / or characteristic, or that an embodiment includes 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 herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," and the like in various places do not necessarily all refer to the same embodiment, nor are they necessarily mutually exclusive separate or alternative embodiments with 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. Additionally, various features are described that may be exhibited by some embodiments and not by others. Similarly, various features or requirements are described that may be a feature or requirement for some embodiments and not for other embodiments.

[0026] In accordance with the principles of the present disclosure, stabilization and leverage devices or tools (such terms are used interchangeably without any intention to limit or otherwise convey a different meaning or intent) include stabilizers and levers. The stabilization and leverage devices may be used in conjunction with a delivery device to be delivered and deployed to a target tissue site. The stabilizers and levers may be incorporated into a tissue stabilization and leverage system. Such systems may incorporate other devices, tools, instruments, components, structures, etc. (such terms are used interchangeably herein for convenience without any intention to limit) known to those skilled in the art or previously developed for performing surgery or procedures, etc. (hereinafter, "procedures" for convenience without any intention to limit) on body parts, such as organs or vessels or tissues. The stabilization and leverage devices are described herein in conjunction with procedures performed on body tissues. However, it will be understood that the procedures need not be so limited. Additionally, the methods of stabilization and leverage disclosed herein, as associated with or performed in conjunction with the devices and systems disclosed herein, are described in conjunction with procedures performed on body tissues, but need not be so limited.

[0027] In embodiments formed according to the principles of the present disclosure, the delivery device is a known device or structure configured to carry and deliver the stabilizer and lever through a body passageway to a target (e.g., a target tissue site) where a procedure is to be performed. The delivery device may be a tube, endoscope, guide lumen, working channel, sheath, port, access port, catheter, passageway, etc. In some embodiments, the delivery device is flexible and / or articulated to allow navigation through non-linear or tortuous body passageways or lumens. The delivery device may include an overtube or other additional passageway connected in any manner known or heretofore known in the art, including, but not limited to, being separate from and extending along the delivery device, or being integral with the delivery device. The overtube may be configured for passage and / or delivery of another element of the device or system therethrough. The overtube and delivery device may be made of the same material or different materials. It will be understood that the stabilizers and related components disclosed herein may be attached to a scope or combined with an overtube through which the scope passes and freely enters and exits.

[0028] The stabilizer is shaped and configured to contact a body portion (e.g., tissue) adjacent to or surrounding a target of the treatment (e.g., a target tissue site) and stabilize the environment in which the treatment is performed, e.g., relative to a working tool (e.g., a medical instrument, endoscope, and / or other device). For example, if the treatment is performed in the gastrointestinal (GI) tract, the stabilizer is shaped and configured to contact the GI tissue and stabilize the target tissue site, e.g., so that autonomous movement (e.g., peristalsis) does not drive the movement of the tissue or otherwise affect the tissue, so that the treatment can be performed without interference or interruption as desired. For example, the stabilizer may be shaped and configured to hold in place and / or stretch tissue at, adjacent to, or surrounding (used interchangeably herein without any limiting intent) the target tissue site. Examples of stabilizers are expandable members (e.g., self-expanding structures such as balloons, stents, meshes, or coil structures, expandable structures that respond to expand when a force is applied, etc.), wire petals, wire bulbs, etc., and the principles of the present disclosure are not necessarily limited to any particular structure.

[0029] The stabilizer is preferably mounted on, worn over, or otherwise attachable to a delivery device and delivered to the target site along with the delivery device, which is configured to facilitate delivery of other devices, instruments, tools, etc. (such terms are used interchangeably herein without limitation) to the target site. Thus, the stabilizer and delivery device together can be considered a stabilization system.

[0030] Target tissue fasteners / anchors / clips or other tissue engaging structures ("fastener" is used herein for convenience, without any intention to be limiting or to convey a different meaning or intent otherwise) are typically used to bind, attach, connect, or grasp, etc., to target tissue. Target tissue fasteners typically have structures shaped and configured to engage / grasp / clamp / hold / connect / fasten / loop around tissue (such terms are used interchangeably herein, without any intention to be limiting or to convey a different meaning or intent otherwise) and may be, without limitation, any of the following fasteners, clips, sutures, corkscrews, barbs, spikes, hooks, helices, graspers, engagement members, staples, adhesives, loops (simple, spiral, helical, etc.), fabric, wire, elastic, etc., or equivalents thereof. Typically, the target tissue fasteners are shaped to engage, grasp, or be coupled to (e.g., looped around, surrounded, etc.) the target tissue, for example, with a grasper or gripping device or other manipulation tool as known or previously known in the art. The target tissue fasteners may or may not be repositionable, such as depending on the need or situation. The target tissue fasteners may optionally be part of a tissue retraction device configured to couple to the target tissue and another element. For example, the tissue retraction device may include a tissue fastener (coupled to the target tissue), a tether, and an anchoring or stabilizing fastener (coupled to another site, such as another tissue site, to stabilize and / or leverage the target tissue fastener).

[0031] As discussed above, it is generally desirable to apply traction to the target tissue by applying traction to the target tissue fasteners to provide leverage to the target tissue. In accordance with the principles of the present disclosure, a lever is provided in conjunction with a tissue stabilizer for use by a clinician to apply traction or tension to the target tissue by leveraging the target tissue anchors (e.g., via the target tissue fasteners) or to otherwise manipulate the target tissue fasteners and the target tissue to facilitate performance of a procedure thereon or thereabout (e.g., by placing the target tissue under tension to facilitate performance of a procedure thereon, i.e., by retracting the tissue to facilitate tissue cutting; facilitating access to the target tissue site, such as a delivery device, scope, tool, etc.; providing sufficient space or clearance for tools to be manipulated or otherwise manipulated to perform the desired procedure; and / or facilitating visualization of the target tissue site). The lever is preferably provided with the stabilizer, e.g., positioned relative to the stabilizer, and is preferably associated with (e.g., coupled to) the stabilizer. Together, the stabilizer and the lever can be considered a stabilization and leverage device. In some embodiments, the lever is coupled to, mounted to or on the stabilizer, or otherwise associated with the stabilizer. In some embodiments, such association is direct. In other embodiments, such association is through another element or component of the stabilization and leverage device. The stabilizer, lever, and delivery device together can be considered to be a stabilization and leverage system.

[0032] The lever includes one or more components arranged, configured, shaped, positioned, etc. to interact with the target tissue (e.g., coupled to the target tissue via tissue fasteners, etc.) and apply a leverage thereto, thereby applying tension or traction to the target tissue. In some embodiments, the lever may include or be associated with a target tissue fastener or tissue retraction device to interact with the target tissue. The lever may include one or more of the following components: a lever tensioner or tensioning mechanism or lever controller (such terms are used interchangeably herein without any intention to limit or otherwise convey a different meaning or intent), a lever tool, a support, a redirection structure, a tissue retraction device. The lever tensioner applies tension or traction or otherwise leverages further components of the lever and / or the target tissue. In some embodiments, the lever tensioner is flexible. In some embodiments, the lever tensioner is a cable, tether, cord, suture, wire, string, dental floss, rod, tube, spring, elastic band, thread, fabric, or the like structure through which tension can be applied or through which another component of the lever or a tissue fastener can be controlled. In some embodiments, the lever tensioner is elastic. In some embodiments, the lever tool is a grasper or other tool that can engage, manipulate, etc., a target tissue, either directly or through another component (e.g., through a tissue fastener or tether). In some embodiments, the support is shaped and configured to support another component, such as a lever tool, or to support and guide another component, such as a tensioner. In some embodiments, the redirection structure is a pivot or passageway or other structure shaped and configured such that another lever component or otherwise that it interacts with changes direction or is redirected for leverage purposes, etc. In some embodiments, the redirection structure is a hook, loop, pulley system, channel, etc. In some embodiments, the tissue retraction device is a tissue engaging and retracting device as known in the art and includes components configured to engage and apply a traction force to a target tissue.One example of a tissue retraction device is a tether retraction device, which has a tether (generally elastic) with a tissue fastener on one end and a fastener, such as a stabilizing anchor or fastener, on the other end (the fastener tethers the tether retraction device so that the tether applies a traction force to the tissue fastener and to the tissue gripped by the tissue fastener). Generally, the various components of the lever may be constructed and / or shaped and / or formed from materials that facilitate movement to apply tension or traction to the target tissue.

[0033] Returning to the discussion of the use of targeted tissue fasteners or tissue retraction devices, it will be appreciated that it is desirable to provide a stabilizing anchor to stabilize the targeted tissue fasteners and / or tissue retraction devices and / or any tensioners that apply tension or traction to the targeted tissue fasteners such that the stability of the targeted tissue is not affected by the delivery device or performance of the procedure on the target tissue (e.g., not affected by movement of a medical instrument or the like within the area of ​​the target tissue or directly on the target tissue). In some embodiments of the present disclosure, the stabilizing anchor may be associated with a stabilizer. The targeted tissue anchors, stabilizing anchors, and tensioners, in combination, may be considered a tissue retraction mechanism.

[0034] In accordance with the principles of the present invention, in use, the stabilization and leverage device leverages the target tissue for various advantages, such as allowing the scope and any instruments or tools (such as within the channel of the scope) to gain access to and visualization of the target tissue, and / or placing the tissue under tension to facilitate manipulation of the instruments or tools relative to the target tissue (e.g., to perform a procedure on the target tissue), and / or lifting, storing, or otherwise manipulating the target tissue while performing a procedure on the target tissue (e.g., cutting under it). When a resection or incision is performed on the target tissue, the target tissue remains with the fasteners once the target tissue is completely resected or incised, and may be removed with the delivery device. The stabilization anchor may be removed (e.g., along with the components of the stabilization and leverage device to which it is coupled) or may be left in place (e.g., when anchored to another tissue) to naturally fall off.

[0035] Referring now to the figures, various embodiments of a stabilization and leverage device combining various embodiments of a delivery device, stabilizer, and lever, and optionally additional embodiments of additional components, devices, instruments, tools, etc., are illustrated to disclose and explain useful examples, without intending to limit the disclosure from the broad principles described herein. FIGS. 1-24 show an embodiment of a stabilization and leverage device 100 formed in accordance with various principles of the disclosure, having a stabilizer 120 and a lever 130 associated with the stabilizer 120, such as by being coupled to the stabilizer 120 (but optionally spaced from the stabilizer 120) or mounted on the stabilizer 120. In some embodiments, the lever 130 is directly coupled to the stabilizer 120. In some embodiments, the lever 130 is coupled to the stabilizer 120 via another component. For example, in some embodiments, the lever 130 is coupled to the stabilizer 120 via a component that may also be used to control and / or operate the stabilizer 120. 1-15, the stabilizer 120 is associated with the delivery device 110 at a location proximal to the distal end 111 of the delivery device. In the embodiment of FIGS. 16-24, the stabilizer 120 is delivered to the target tissue site T by the delivery device 110 and then moved distally such that the stabilizer 120 is positioned distal to the distal end 111 of the delivery device 110 during the performance of the procedure on the target site T.

[0036] In some embodiments, the stabilizer 120 of the stabilization and leverage device 100 formed according to the principles of the present disclosure may be in the form of an expandable stabilizer, the expansion of which applies pressure or tension, etc., to stabilize the target tissue T and also provides leverage for the lever 130 and / or other tensioners and / or fasteners and / or tools that leverage the target tissue T. The expandable stabilizer is preferably in a stored or compact configuration while being navigated to the target tissue site S with the delivery device 110. The stabilizer 120 is deployed, e.g., inflated or expanded, or otherwise configured and positioned to engage a body site at, adjacent to, in the vicinity of the target tissue site S, etc. (such terms are used interchangeably herein, without any intended limitation) to stabilize such body site (e.g., tissue) to facilitate performance of a desired procedure at the target tissue site S (e.g., on the target tissue T). In some embodiments, the stabilizer 120 is in the form of an inflatable stabilizing device, such as an inflatable balloon, that is inflated via any inflation / deflation mechanism known or heretofore known in the art, such as, for example, an inflation tube or lumen (such mechanism is not critical to the stabilization and leverage principles of the present disclosure). In some embodiments, a control tube or deployment tube or inflation tube / lumen, or the like, is in fluid communication with the inflatable stabilizer, through which a fluid (e.g., air or water) is passed to inflate the inflatable stabilizer, or suction is applied therethrough to deflate the inflatable stabilizer. In some embodiments, the stabilizer 120 is in the form of an expandable stent stabilizer, which may be deployed in a compressed configuration, and may be expanded as needed, such as by manipulating the stent stabilizer to release a constraint thereon (maintaining the stent stabilizer in a compressed configuration). In some embodiments, a controller, such as a cable or wire, or other stent operator or controller known in the art or previously known (such elements are not critical to the stabilization and leverage principles of the present disclosure), is manipulated (e.g., from its proximal end) to manipulate the stent stabilizer to expand or compress.

[0037] The delivery device 110 shown in the figures herein is an endoscope with a delivery lumen or passageway or working channel 112 ("working channel" is used generally herein for convenience and not for limitation) through which a working tool 180 (e.g., a cutting tool) may be transported to a delivery site / target tissue site S at any time during a procedure. However, it will be understood that other forms of delivery device 110 are within the scope of this disclosure and that the present embodiment shows an endoscope only for convenience of illustration. As shown, a stabilizer 120 is mounted to (e.g., mounted on or positioned on) a portion of the delivery device 110 (e.g., coupled to the exterior of the delivery device 110, such as by passing the delivery device 110 through a passageway 124 through the stabilizer 120).

[0038] The stabilizer 120 of the embodiment of Figures 1-7 has a passageway 124 through which a lever tool, device, or instrument 190, such as a grasper (used alternatively in connection with the term "lever" without any intended limitation, with the understanding that the tool, device, instrument, etc. is not critical to the principles of stabilization and leverage disclosed herein) passes to reach and manipulate the target tissue T to exert leverage on the target tissue T. It will be understood that in the embodiment of Figures 1-7, the lever tool 190 may be a tensioner and fastener (such terms are used interchangeably without any intended limitation) that directly grasps, engages, fastens, etc. the target tissue T (as shown in Figure 1), or a combination of a grasper or clip and a separate tensioner / fastener (e.g., as shown in Figure 5). A lever 130 is associated with the stabilizer 120 to exert leverage on the lever tool 190, which may be considered a component of the lever 130. 1-7, the lever 130 includes a support elevator 132 configured to elevate the lever tool 190 relative to the stabilizer 120 to leverage the target tissue T. The elevator 132 may be in any of a variety of different forms or configurations, some examples of which are described herein. The lever 130 may include a lever controller 134 through which the lever 130 and / or its components (e.g., the elevator 132) may be operated or manipulated or navigated (such terms are used interchangeably herein without any limitation intended).

[0039] 1 is in the form of a wedge or flipper or other movable (e.g., pivotable) support elevator 232 that supports or is otherwise engaged with the lever tool 190 such that movement of the support elevator 232 causes a desired movement (e.g., lifting, elevation, or other movement such as lateral) of the lever tool 190 to provide leverage as desired on the target tissue T. Movement or control of the support elevator 232 may be achieved through manipulation of a controller 234 (e.g., a balloon, or cable, tether, cord, suture, controller, etc., such terms are used interchangeably herein without intended to be limiting, and it will be understood that a controller for support is not critical to the stabilization and leverage principles disclosed herein) at the proximal end 115 (e.g., handle) of the delivery device 110.

[0040] The examples of elevators 132 shown in Figures 2 and 3 are in the form of support channels 332, 432 that support or are coupled or engaged to the lever tool 190 such that movement of the support channels 332, 432 (e.g., side-open channels 332 as shown in Figure 2, or fully closed channels 432 as shown in Figure 3) causes a desired movement of the lever tool 190 (e.g., lifting, elevation, or other movement such as lateral) thereby levering the target tissue T as desired. Movement or control of the support channels 332, 432 may be achieved through manipulation of a lever controller 334, 434 (e.g., cable, tether, cord, suture, controller, etc., such terms are used interchangeably without intended to be limiting, and it will be understood that the controller is not critical to the stabilization and leverage principles disclosed herein) at the proximal end 113 (e.g., handle) of the delivery device 110. For example, the distal ends 333, 433 of the controllers 334, 434 may be coupled to the support channels 332, 432 and the proximal ends 335, 435 of the controllers 334, 434 may be accessible for manipulation at the proximal end 115 of the delivery device 110.

[0041] In the embodiment of FIG. 2, the support channel 332 is an open-sided channel that supports the lever tool 190 from below. The support channel 332 is mounted in the passage 124 in the stabilizer 120 via a redirecting structure (e.g., pivotally mounted via a pivot pin 336) at one end (e.g., proximal end 339) of the support channel 332, and the distal end 333 of the controller 334 is coupled to the distal end 337 of the support channel 332 (e.g., via a hook or slit or other fastening structure 338 to the exterior or end of the support channel 332). Pulling on the proximal end 335 of the controller 334 causes the distal end 333 of the controller 334 to pivot, leverage, or otherwise move the support channel 332 to move or leverage the lever tool 190, thereby levering tissue grasped or otherwise engaged by the lever tool 190.

[0042] 3, the support channel 432 is a substantially closed channel that surrounds the lever tool 190 to support it. The support channel 432 is freely movable within the passageway 124 in the stabilizer 120 and is moved (e.g., lifted) by the controller 134 and then leveraged within the passageway 124, such as by passing around a redirecting structure 436, such as a lever point or pivot or pulley. In the illustrated example, the controller 134 is in the form of a tensioner 434 (e.g., a cable, tether, cord, suture, controller, etc.) that is coupled at one end to the support channel 432 (e.g., to an outer surface of the support channel 432 via any connection known in the art) and extends around the redirecting structure 436 within the passageway 124 of the stabilizer 120. The redirecting structure 436 may be a pivot pin or other structure around which the controller 134 may be passed such that movement of the controller 134 leverages (e.g., raises or lowers) the support channel 430, thereby leveraging the lever tool 190 and the target tissue T associated or coupled therewith. In use, pulling on the proximal end 435 of the controller 434 causes the distal end 433 of the controller 434 to pivot, leverage, or otherwise move the support channel 430 within the passageway 124 of the stabilizer 120, thereby moving or levering the lever tool 190, thereby levering tissue grasped or otherwise engaged by the lever tool 190.

[0043] In the embodiment of FIGS. 4 and 5, the lever tool 190 passes through a working channel 532 and is supported and moved by the lever 130 which includes the working channel 532. The working channel 532 passes through a passage 124 in the stabilizer 120. In some embodiments, the working channel 532 may be freely movable within the passage 124 to move (e.g., lift) and leverage the lever tool 190 and the target tissue engaged by the lever tool 190. In one embodiment, the working channel 532 extends the entire length of the delivery device 110 and is movable (e.g., may be pulled or pushed) from the proximal end 115 of the delivery device 110 to move a distal end 533 of the working channel 532 and thereby leverage the lever tool 190. In one embodiment, the working channel 532 may facilitate or guide movement of the working channel 532 within the passage 124 by engaging the stabilizer 120, such as via an inner wall of the passage 124. In one embodiment, a lever engagement of the working channel and stabilizer, such as a pivot or pulley or other redirecting structure, may be provided. For example, in the embodiment shown in FIGS. 4 and 5, the lever engagement is in the form of a protrusion or pin 536 on one of the working channel 532 and passageway 124 and a slot 538 in the other of the working channel 532 and passageway 124. For example, the slot 538 may be in the form of a curved slot or channel, etc., shaped and configured to engage and / or receive the pin 536 to allow relative movement therebetween, resulting in movement of the working channel 532 and consequent movement of the lever tool 190 to provide a leverage on the target tissue T. In one embodiment as shown by way of example in FIGS. 4 and 5, in use, as the working channel 532 is moved distally, the pin 536 protruding from its side moves upward along the slot 538 extending distally upward. The lever tool 190 is thereby moved distally from the delivery device 110 and levered upwardly to apply upward leverage to the target tissue T (which may be adjacent to the underside of the stabilization and leverage device 100), such as via a separate tissue retraction device 192 as known in the art.For example, tissue retraction device 192 may include a tether 194 with tissue fasteners 196, 198 at each end thereof. The tissue fasteners are shown generally throughout the figures and encompass tissue fasteners known and heretofore known in the art, it will be understood that the present disclosure is not limited by any particular tissue fastener configuration.

[0044] In the embodiment of FIGS. 6 and 7, the lever tool 190 is supported and moved by a lever 130 that includes a secondary fluid balloon 632. In one embodiment, the secondary fluid balloon 632 has a lumen 634 (e.g., an inflation tube or hose, etc.) that extends the entire length of the delivery device 110, with the balloon 636 at the distal end 633 of the lumen 634. The distal end 637 of the secondary fluid balloon 632 passes through a passageway 124 in the stabilizer 120, thereby positioning the secondary fluid balloon 632 within the passageway 124. Fluid (e.g., air or water) may pass through the proximal end 635 of the lumen 631 to fill the secondary fluid balloon 632. Once the secondary fluid balloon 632 is filled, the secondary fluid balloon 632 expands to act as an elevator to lift the lever tool 190, thereby providing a leverage to the lever tool 190 and the target tissue T coupled thereto. In one embodiment, the secondary fluid balloon 632 is inserted via a separate balloon channel in the delivery device 110. In one embodiment, the secondary fluid balloon 632 is loaded into a separate working channel of the delivery device 110, such as via a deployment catheter (as known in the art and therefore not shown to simplify the drawing).

[0045] In some embodiments, such as those shown in Figures 8-11, expansion of the expandable stabilizer 120 can provide tissue stabilization as well as leverage to the lever 130 component of the stabilization and leverage device 100. In the embodiment of Figures 8 and 9, the expandable stabilizer is in the form of an expandable stent stabilizer 720, and in the embodiment of Figures 10 and 11, the expandable stabilizer is in the form of an inflatable balloon stabilizer 820. Expansion of the expandable stabilizers 720, 820 (e.g., via stabilizer controllers 742, 842, such as control wires or inflation tubes, respectively) brings the expandable stabilizers 720, 820 to a desired size to engage a body site, such as at, adjacent to, or near the target tissue site S, thereby stabilizing the target tissue site S in accordance with the principles of the present disclosure. The lever 130 extends through a channel or passageway 724, 824 (such terms are used interchangeably without intended limitation) associated with (e.g., extending along, into / through, or over) the expandable stabilizer 720, 820 and is leveraged by the expandable stabilizer 730, 820, such as upon expansion of the expandable stabilizer 720, 820, to apply a desired leverage to the target tissue T. More specifically, in one embodiment, the lever 730, 830 includes a lever tensioner 734, 834 that extends through the stabilizer passageway 724, 824 and is coupled to the target tissue T via a tissue fastener or tissue retraction device, or the like, as known or heretofore known in the art. In some embodiments, the lever 730, 830 may include a lever tool, as described herein, coupled to a tissue fastener or tissue retraction device. Adjustment (e.g., expansion, inflation, contraction, movement, etc.) of the expandable stabilizer 720, 820 exerts a leverage on the lever tensioner 734, 834 that passes through the passageway 724, 824 through the stabilizer 720, 820, such that the expanded passageway 724, 824 of the stabilizer 720, 820 acts as a lever in this embodiment. It will be appreciated that such leverage can be achieved regardless of whether the passageway 724, 824 extends the entire length of the delivery device 110 or not.In the illustrated embodiment, the passages 724, 824 are located at the top of the expandable stabilizers 720, 820 and the target tissue T is located on the other side thereof (e.g., at the bottom of the expandable stabilizers 720, 820) so that expansion of the expandable stabilizers 720, 820 lifts the lever tensioners 734, 834 to leverage the target tissue T, for example, via the tissue fasteners 796, 896 (shown diagrammatically with optional tethers 794, 894 extending between the tissue fasteners 796, 896 and the lever tensioners 734, 834). The lever tensioners 734, 834 may be manipulated (e.g., pulled or otherwise moved) such as via their proximal ends 735, 835 (such as the proximal end 115 of the delivery device 110) to apply additional traction to the lever tensioners 734, 834 and the target tissue T. In the embodiment shown in Figures 8-11, movement of the lever tensioner 734, 834 through the passages 724, 824 in the expandable stabilizer 720, 820 provides leverage such that when the lever tensioner 734, 834 is pulled at its proximal end 735, 835, it is pulled at an upward angle to facilitate access to the target tissue T, such as by allowing access for a cutting tool (e.g., an ESD knife) to cut underneath the target tissue T (e.g., a lesion).

[0046] The tensioner / controller 734, 834 may be in the form of a typical tensioner or controller used in conjunction with the target tissue fastener 196 to apply tension or leverage thereto to lift or leverage the target tissue T to facilitate performance of a procedure on the target tissue T. Alternatively, the tensioner / controller 734, 834 may be a separate controller coupled to the typical tensioner or controller that is coupled to the target tissue fastener 196. In either configuration (the disclosure is not limited to any of the configurations or alternative configurations not critical to the broader stabilization and leverage principles disclosed herein), the tensioner / controller 734, 834 extends through the passages 724, 824 to the proximal end 113 of the delivery device 110, and the proximal end 733 of the tensioner / controller 734, 834 can be manipulated to affect (e.g., increase, decrease, change direction, etc.) the tension on the tensioner / controller 734, 834, thereby affecting the tension on the target tissue fastener 196.

[0047] In use, tissue fasteners 796, 896 or tissue retraction devices or the like can optionally be extended or deployed or delivered to the target tissue T through the working channel 112 of the delivery device 110 of the embodiment shown in Figures 8-11. Tensioners 734, 834, such as in the form of sutures, wires, cables, tethers, cords, or the like, are coupled to the target tissue fasteners 196 and extend along the delivery device 110 through passages 724, 824 through the expandable stabilizers 720, 820 to the proximal end 113 of the delivery device 110. When the delivery device 110 reaches the target tissue site S, the expandable stabilizers 720, 820 are expanded to provide stabilization and the tissue fasteners 796, 896 are deployed or otherwise attached to the target tissue T. When the expandable stabilizer 720, 820 is expanded, the lever tensioner 734, 834 is lifted therewith, providing leverage on the tissue fasteners 796, 896. When further leverage or lifting of the target tissue T is desired or needed, the lever tensioner 734, 834 is manipulated (e.g., pulled) at its proximal end 735 (generally at the proximal end 113 of the delivery device 110) to provide the desired leverage, such as to lift the target tissue T to a desired point.

[0048] Similar leverage of the target tissue T described with reference to Figures 8-11 (e.g., via leverage between the target tissue fastener 196 and the expandable stabilizer 120) may be achieved in the embodiments of Figures 12-15, which similarly include an expandable stabilizer 120, such as in the form of the expandable stent stabilizer 920 shown in Figures 12 and 13, or the inflatable balloon stabilizer 1020 shown in Figures 14 and 15. However, instead of a lever 130 extending through a passage through the expandable stabilizer 120 or including a tensioner associated with the expandable stabilizer 120, the lever 130 of the embodiments of Figures 12-15 includes a tether 994, 1094 coupled to the expandable stabilizer 920, 1020. For example, in the embodiments of Figures 12 and 13, the tether 994 may be attached directly to or woven into the material of the expandable stent stabilizer 920. In the embodiment of FIGS. 14 and 15, the tether 1094 may be coupled, such as by being directly attached, to the inside or outside of the inflatable balloon stabilizer 1020 .

[0049] In one embodiment, the tether 994, 1094 may be a resilient material coupled at one end to the expandable stabilizer 920, 1020 and at another end to the tissue fastener 196. The tissue fastener 196 (shown diagrammatically) may be coupled to the target tissue T using a tool, such as a grasper, inserted into the target tissue site S via the working channel 112 of the delivery device 110 (see, e.g., FIG. 1). Movement of the expandable stabilizer 920, 1020 (e.g., upon expansion thereof, e.g., via stabilizer controllers 942, 1042, e.g., control wires or inflation tubes, respectively, in a manner as described in connection with the expandable stabilizers 720, 820 of the embodiment shown in FIGS. 8-11) applies a force or tension to the tether 994, 1094, thereby leveraging the tissue fastener 196 attached thereto, and thereby leveraging the target tissue T. When the target tissue T is fully transected, the lesion can either remain attached to the tissue fasteners 196 and be removed along with the delivery device 110, or the graspers can detach the tissue fasteners 196 from the target tissue T. It will be appreciated that, similar to the embodiment of Figures 8-11, the stabilization and leverage device 900, 1000 of Figures 12-15 similarly stabilizes tissue at, adjacent to, or surrounding the target tissue T upon expansion of its expandable stabilizers 920, 1020, and leverages the lever 130 to provide leverage to the target tissue T.

[0050] It will be appreciated that in the embodiments described thus far, lever 130 is associated with stabilizer 120, such as by being mounted to or formed with stabilizer 120. In alternative embodiments of stabilization and leverage device 100 formed in accordance with the principles of the present disclosure, lever 130 may be associated with stabilizer 120 via another component of stabilization and leverage device 100. For example, in the embodiment of FIGS. 16-20 , lever 130 is coupled to stabilizer 120 via stabilizer controller 142 coupled to stabilizer 120 to deploy and / or control and / or navigate and / or operate (used interchangeably herein without any limiting intent) stabilizer 120. For example, in the embodiment of FIGS. 16-20 in which the illustrated stabilizer 120 is in the form of an inflatable stabilizer, the stabilizer controller 142 may be a stabilizer controller 1142, 1242, 1342 in the form of a control tube and / or inflation lumen (e.g., that may be pushed, pulled, moved sideways or up and down) that may be used not only to manipulate the position of the stabilizer 120 but also to control the stabilization provided by the stabilizer 120 (e.g., by providing fluid control to the stabilizer 120 to control its expansion and thus the support or pressure applied to the target tissue site S to stabilize the target tissue site S). One end (or component) of the lever 130 in the embodiment of FIGS. 16-20 is coupled to or supported by the stabilizer controller 1142, 1242, 1342 and the other end (or another component) is coupled to the target tissue T, such as via a tissue fastener 196 (shown diagrammatically). In some embodiments, the lever 130 includes a tether 194 having one end coupled to a tissue fastener 196 that is coupled to the target tissue T and another end coupled to the stabilizer controller 142 .

[0051] In use, the stabilizer 120 of the embodiment of Figures 16-20 may be mounted on a distal end of a delivery device 110, as shown in Figure 16. In the illustrated embodiment of Figures 16-20, the stabilizer controller 142 is mounted on or extends along the delivery device 110 such that the stabilizer 120 is delivered by the delivery device 110 to the target tissue site S. In some embodiments, a rigid or semi-rigid attachment may be used to mount the stabilizer controller 1142, 1242, 1342 along the delivery device 110, extending from the distal end 111 of the delivery device 110 to the proximal end 113 of the delivery device 110, to urge the stabilizer 120 distally against the target tissue site S. 16-20 reach the target tissue site S, the stabilizer 120 is moved distally beyond the distal end 111 of the delivery device 110 and moved distally beyond the target tissue site S. The stabilizer controllers 1142, 1242, 1342 can be operated by manipulating the proximal ends 1143, 1243, 1343 of the stabilizer controllers 1142, 1242, 1342. Typically, the stabilizer 120 is deployed in an unexpanded (e.g., uninflated) configuration and expanded (e.g., via the stabilizer controllers 1142, 1242, 1342 if in the form of an inflation tube, or inflated if in the form of a balloon) after being positioned beyond the target tissue site S to stabilize tissue at / slightly distal to the target tissue site S. Once the stabilizer 120 is deployed to stabilize the target tissue site S and the lever 130 is coupled to and leverages the target tissue T (e.g., via tissue fasteners and / or tissue retractors, etc.), additional tools may be deployed to perform a desired procedure on the target tissue T or others. It will be appreciated that the delivery device 110 and any additional tools delivered or deployed via the delivery device 110 are movable independently of the stabilizer 120, such that the stabilizer 120 effectively stabilizes the target tissue site S in accordance with the principles of the present disclosure. Independent movement of the delivery device 110 (relative to the stabilizer 120 and lever 130) is illustrated diagrammatically in FIG. 17 (a dashed line view of the delivery device 110 showing alternative positions of the delivery device 110).Leverage can be adjusted by manipulating the position of the ballast controllers 1142, 1242, 1342 and / or the ballasts 1120, 1220, 1320, as desired.

[0052] In the embodiment shown in FIG. 18 , the lever 1130 includes one or more tethers 1194 (typically elastic members or the like as generally described herein and known in the art) with a first end 1191 coupled or mounted to the stabilizer controller 1142 and a second end 1193 coupled to a target tissue fastener 1196. Thus, two or more target tissue fasteners 1196 may be coupled to different locations along the target tissue T to lift the tissue as desired. Each target tissue fastener 1196 is also typically coupled to the stabilizer controller 1142 on different portions (e.g., different control tubes) of the stabilizer controller 1142 on different sides of the target tissue T. The target tissue fasteners 1196 may be repositionably or non-repositionably coupled to the target tissue T such that the lever 1130 exerts a leverage on the target tissue T. The target tissue fasteners 1196 may be manipulated, for example, with a grasper. The coupling of the lever 1130 to the stabilizer controller 1142 stabilizes the lever 1130 relative to the target tissue T to provide leverage on the target tissue T as needed or desired. The stabilizer controller 1142 may also be operated to manipulate the lever 1130.

[0053] 19, the lever 1230 is a tether 1294 (e.g., a cable or cord or suture as generally described herein and known in the art, etc.) that passes through an opening 1244 in the stabilizer controller 1242 and extends through the stabilizer controller 1242 to the proximal end 113 of the delivery device 110. It will be appreciated that in this embodiment, more than one stabilizer controller 1242 in the form of a tube is provided, with at least one being an inflation tube coupled to inflate the expandable stabilizer 1220 and one being a tube through which the tether 1294 passes. A distal end 1291 of the tether 1294 is coupled to a target tissue fastener 1296 that is repositionably or non-repositionably coupled to the target tissue T, and a proximal end 1293 of the tether 1294 is accessible to a clinician (e.g., at the proximal end 113 of the delivery device 110) to manipulate the tether 1294 to leverage the lever 1230 and (coupled thereto) the target tissue T, as desired or necessary. It will be appreciated that the opening 1244 and entry / exit points of the tether 1294 to / from the stabilizer controller 1242 may function as a redirection structure for the lever 130, which leverages the tether 1294 and the target tissue fastener 1296 when the proximal end 1293 of the tether 1294 is manipulated, thereby leveraging the target tissue T.

[0054] In the embodiment shown in FIG. 20, the lever 1330 includes a tether 1394 (e.g., a cable or cord or suture as generally described herein and known in the art) that extends along a stabilizer controller 1342. A distal end 1391 of the tether 1394 is coupled to a target tissue fastener 1396 that is repositionably or non-repositionably coupled to the target tissue T, and a proximal end 1393 of the tether 1294 is accessible to a clinician to manipulate the tether 1294 to provide leverage on the lever 1230 and the target tissue T (to which it is coupled) as desired or required. A redirection structure 1344 may be provided to provide leverage on the tether 1394 when the proximal end 1393 of the tether 1394 is manipulated. In the embodiment shown in FIG. 20, the redirection structure 1344 is a structure having an opening through which the tether 1394 passes, such as a loop or pulley or eyelet. In one embodiment, steering structure 1344 is mounted on (eg, external to) ballast controller 1342 .

[0055] The stabilizer 120 of the stabilization and leverage device 100 formed in accordance with the general principles of the present disclosure to be delivered distal to the target tissue site S may be delivered to the target tissue site S by advancing in front of the delivery device 110, as in the embodiment of FIGS. 21-24, instead of being mounted on the delivery device 110 as in the embodiment of FIGS. 16-20. For example, the stabilizer 120 may be delivered via a releasable cap on the distal end 111 of the delivery device 110, or in the form or configuration of a releasable cap. For example, in the embodiment shown in FIGS. 21 and 22, the stabilizer 120 is in the form of an inflatable balloon stabilizer 1420. Preferably, the stabilizer 1420 is a transparent balloon to allow visualization therethrough and facilitate navigation of the delivery device 110 to the target tissue site S. In some embodiments, the stabilizer 1420 has a delivery device interface 1444, such as a distal facing seat, formed on the distal side of the stabilizer 1420 that is shaped and configured to receive the distal end 111 of the delivery device 110 such that the stabilizer 1420 rests on the distal end 111 of the delivery device 110 during navigation and delivery to the target tissue site S. In the embodiment of FIGS. 23 and 24, the stabilizer 120 is in the form of an inflatable balloon stabilizer 1520 similar to the inflatable balloon stabilizer 1420 of the embodiment of FIGS. 21 and 22, except that it is toroidal in shape with a passageway or opening 1524 therethrough to allow navigation of an endoscope or other tool therethrough, if desired. A separately formed central ring (e.g., formed from a material that is more rigid than the material of the stabilizer 1420) may be provided within the opening 1524.

[0056] A stabilizer controller 142, such as in the form of an inflation tube 1442, 1542, extends along the delivery device 110 (either to the side and outside of the delivery device 110, or along and within its working channel 112). When the distal end 111 of the delivery device 110 reaches the target tissue site S, the stabilizers 1420, 1520 are advanced distally and then expanded (e.g., inflated by passing a fluid, such as air or fluid, through the stabilizer controller 1442, 1542) to stabilize the target tissue site S and enable independent operation of any tools passing through the delivery device 110 and its working channel 112.

[0057] In the embodiment of FIGS. 21-24, the lever 1430 includes a tissue retraction device 192 that is delivered through the working channel 112 of the delivery device 110. In some embodiments, the tissue retraction device 192 is pre-loaded onto the stabilizer 120. It will be appreciated that in FIG. 21, the delivery device 110 is shown partially cut away to show the tissue retraction device 192 carried by the stabilizer 1420. In other words, the stabilizer 1420 is pre-loaded with the tissue retraction device 192 when the stabilizer 1420 is delivered through the delivery device 110 (e.g., loaded onto the front of the delivery device 110 with the tissue retraction device 192 carried within the working channel 112 of the delivery device 110). Once the stabilizer 120 is deployed and stabilizes the target tissue T, the tissue retraction device 192 can be coupled to the target tissue T (e.g., as illustrated in FIG. 24). For example, in embodiments in which the tissue retraction device 192 includes a tether 1494 (e.g., an elastic member such as a rubber band) and tissue fasteners 1496, 1498 (e.g., in the form of loops), one tissue fastener 1496 can be coupled (e.g., pre-attached) to the stabilizer 1420 and the other tissue fastener 1498 can be coupled to the target tissue T (e.g., by use of a clip and / or grasper as illustrated in FIG. 23 ), and the tether 1494 can apply a traction force to the target tissue T.

[0058] It should be understood that stabilization and leverage devices and systems according to the principles of the present disclosure may be used for procedures in or adjacent to various body organs, such as the esophagus, heart, stomach, pelvic region, bladder, intestines, or any portion of the gastrointestinal, urinary, or pulmonary tract.

[0059] The delivery device used herein may be of any suitable size, cross-sectional shape or area, and / or configuration that allows the introduction and passage of medical instruments into the distal end of the delivery device. It is generally beneficial for the delivery device to be steerable, and the delivery device may have multiple regions of different flexibility or stiffness to facilitate steerability. The delivery device may include one or more working channels that extend substantially longitudinally (axially) between the proximal and distal ends of the delivery device. The delivery device and / or the overtube associated therewith may be made of any suitable biocompatible material known to those skilled in the art and that has sufficient flexibility to traverse non-linear or tortuous anatomy. Such materials include, but are not limited to, rubber, silicone, synthetic plastics, stainless steel, metal-polymer composites; metal alloys of nickel, titanium, copper, cobalt, vanadium, chromium, and iron; superelastic or shape memory materials such as Nitinol (nickel-titanium alloy); different layers of different materials, and reinforcements. Such materials may be made from or coated with a polymeric or lubricious material to allow or facilitate passage of a delivery device therethrough. In some embodiments, the working channel may be made from or coated with a polymeric or lubricious material to facilitate passage of an introduced medical instrument through the working channel.

[0060] The medical devices, instruments, tools, etc. of the present disclosure may include various medical devices, instruments, tools, etc. for accessing body passageways, including, but not limited to, duodenoscopes, catheters, ureteroscopes, bronchoscopes, colonoscopes, arthroscopes, cystoscopes, hysteroscopes, etc. A variety of medical devices, instruments, tools, etc. may be used in conjunction with a stabilization and leverage device formed in accordance with the principles of the present disclosure. For example, such instruments or tools may be used to perform procedures or operations that are either diagnostic or therapeutic or both, such as grasping, resecting, dissecting, retracting, cutting, and / or otherwise manipulating tissue. Such instruments or tools include graspers (e.g., a rotatable grasping clip, such as the RESOLUTION® Clip Device sold by Boston Scientific Corporation, with a pair of jaws / arms, etc.), cutting tools (e.g., knives, electrocautery devices, scissors), snares, etc.

[0061] The stents used in the stabilization and leverage devices as disclosed herein may be braids and / or twisted lattices of wire, helical or semi-helical spirals, and / or multiple wavy, corrugated, or sinusoidal rings. The stents used in the stabilization and leverage devices as disclosed herein may be made at least in part from shape memory materials (e.g., cobalt-chromium-nickel alloys such as Elgiloy, synthetic plastics, stainless steel, superelastic metal alloys of nickel and titanium (e.g., Nitinol), other metal alloys such as copper, cobalt, vanadium, chromium, iron, powdered metals, ceramics, thermoplastic composites, ceramic composites, or polymers, and / or any combination thereof).

[0062] Target tissue fasteners used with stabilizer and leverage devices formed in accordance with the principles of the present disclosure may be formed from one or more of metal, wire, plastic, or generally resilient materials.

[0063] Lever components used with stabilizers and leverage devices formed according to the principles of the present disclosure may be formed of plastic, metal, elastomer, and / or the same material as the stabilizer or delivery device. The lever may be coated with duraskin, a PTFE "Teflon" based material, to allow the tensioner component to more easily slide, such as be moved proximally, to apply tension to the target tissue.

[0064] 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 merely examples, not the only ways 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 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.

[0065] In the foregoing description and in the claims that follow, 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. 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, etc.) are used for identification purposes only to aid the reader's understanding of this disclosure and / or serve to distinguish regions of associated elements from one another, and do not limit the associated elements, particularly with respect to the position, orientation, or use of this disclosure. Connection references (e.g., attached, coupled, connected, and joined) should be interpreted broadly and may include intermediate members between a collection of elements and relative movement between the elements, unless otherwise indicated. Thus, connection references do not necessarily imply 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.

[0066] The foregoing discussion is presented for purposes of illustration and description, and is not intended to limit the disclosure to one or more 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 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, 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 disclosure are grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that various features of a particular aspect, embodiment, or configuration of the disclosure may be combined in alternative aspects, embodiments, or configurations. Those skilled in the art will understand that the disclosure may be used with many modifications of the structures, arrangements, ratios, materials, components, and the like used in the implementation of the disclosure that are specifically adapted to a particular environment and operating requirements without departing from the principles of the disclosure. For example, elements shown as integrally formed may be comprised of multiple pieces or elements shown as multiple pieces may be integrally formed, the operation of elements may be reversed or otherwise changed, sizes or dimensions of elements may be changed, etc. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the claimed invention being indicated by the appended claims, and not limited by the foregoing description.

[0067] The following claims are incorporated by reference into this detailed description, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the term "comprises" does not exclude the presence of other elements or steps. Furthermore, although individually recited, a plurality of means, elements or method steps may be implemented, for example, by a single unit or processor. In addition, although individual features may be included in different claims, they may in some cases be advantageously combined, and the inclusion in different claims does not imply that the combination of features is not feasible and / or advantageous. In addition, singular references do not exclude a plurality. Terms such as "a", "an", "first", "second" etc. do not exclude a plurality. Reference signs in the claims are provided merely as a clarifying example and should not be interpreted as limiting the scope of the claims in any way.

Claims

1. a stabilizer configured to mount onto the delivery device; a lever extending between a target tissue and the stabilizer to provide a leverage against the target tissue; A stabilization and leverage device configured to be mounted to the delivery device such that the stabilizer contacts and stabilizes the target tissue independent of the distal end of the delivery device and allows independent free movement of the delivery device and an instrument extending through the delivery device relative to the stabilizer and the target tissue during use.

2. a stabilizer passageway extending from a proximal end to a distal end of the stabilizer; 2. The stabilization and leverage device of claim 1, wherein the lever includes a lever component extending from a first end coupled to the target tissue, through the stabilizer passageway, to a second end controllable from a proximal end of the delivery device to exert a leverage effect on the target tissue.

3. the lever component includes a lever tool extending through the stabilizer passage; The lever includes a support elevator; the support elevator includes one of a flapper, a support and a lever controller coupled to the support, a working channel, or a secondary inflatable balloon; The stabilizing and leveraging device of claim 2 , wherein the support elevator is configured to support and leverage the lever tool.

4. the ballast is an expandable ballast; the lever includes a tensioner extending between the expandable stabilizer and the target tissue; The stabilization and leverage device of claim 1 , wherein expansion of the expandable stabilizer exerts a leverage effect on the lever and the target tissue.

5. the stabilization and leverage device further includes a stabilizer controller to facilitate manipulation of the stabilizer from a proximal end of the delivery device; 2. The stabilization and leverage device of claim 1, wherein the lever comprises at least one of: a tether having a first end coupled to the target tissue and a second end coupled to the stabilizer controller; a tether extending from the first end coupled to the target tissue, through the stabilizer controller, to a second end accessible at a proximal end of the delivery device for manipulation to apply leverage to the target tissue; and a tether extending from the first end coupled to the target tissue, through a redirection structure on the stabilizer controller, along the stabilizer controller, to a second end accessible at a proximal end of the delivery device for manipulation to apply leverage to the target tissue.

6. 10. The stabilization and leverage device of claim 1, wherein the stabilizer has a delivery device interface shaped and configured to receive a distal end of the delivery device during deployment of the stabilization and leverage device with the delivery device to a target tissue site.

7. 7. The stabilization and leverage device of claim 6, wherein the lever comprises a lever component that is mounted through a working channel of the delivery device and onto a proximal end of the stabilizer that is mounted on a distal end of the delivery device prior to delivery of the stabilizer.

8. A delivery device. a stabilizer configured to be mounted to the delivery device; a lever extending between a target tissue and the stabilizer to provide a leverage on the target tissue; a stabilizer controller that facilitates operation of the stabilizer from a proximal end of the delivery device; A stabilization and leverage system for delivery to a target tissue site, wherein the stabilizer stabilizes the target tissue independent of the distal end of the delivery device and enables independent movement of the delivery device and an instrument extending through the delivery device relative to the stabilizer and the target tissue.

9. the ballast includes a ballast passage; 9. The stabilization and leverage system of claim 8, wherein the lever includes a lever component coupled from a proximal end of the delivery device through the stabilizer passage to a target tissue distal to the delivery device to exert a leverage on the target tissue.

10. The lever includes a support elevator; the stabilizer passage is configured to pass a tensioner therethrough for engagement with the target tissue; The stabilization and leverage system of claim 9 , wherein the support elevator and the stabilizer passage provide leverage to the tensioner to provide leverage to the target tissue.

11. the lever component includes a lever tool extending through the stabilizer passage; The lever includes a support elevator; the support elevator comprises one of a flapper, a support and a lever controller coupled to the support, a working channel, or a secondary inflatable balloon; The stabilization and leverage system of claim 10 , wherein the support elevator is configured to support and leverage the lever tool.

12. the ballast is an expandable ballast having a ballast passage; the lever includes a tensioner extending between the expandable stabilizer and the target tissue; The stabilization and leverage system of claim 8 , wherein expansion of the expandable stabilizer exerts a leverage effect on the lever and the target tissue.

13. 9. The stabilization and leverage system of claim 8, wherein the lever comprises at least one of: a tether having a first end coupled to the target tissue and a second end coupled to the stabilizer controller; a tether extending from the first end coupled to the target tissue, through the stabilizer controller, to a second end accessible at a proximal end of the delivery device for manipulation to leverage the target tissue; and a tether extending from the first end coupled to the target tissue, through a redirection structure on the stabilizer controller, along the stabilizer controller, to a second end accessible at a proximal end of the delivery device for manipulation to leverage the target tissue.

14. the stabilizer has a delivery device interface shaped and configured to receive a distal end of the delivery device during deployment of the stabilization and leverage device with the delivery device to a target tissue site; 9. The stabilization and leverage system of claim 8, wherein the lever comprises a lever component that is mounted through a working channel of the delivery device and onto a proximal end of the stabilizer that is mounted on a distal end of the delivery device prior to delivery of the stabilizer.

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