Various aspects of the present disclosure relate generally to tissue retraction. More specifically, the present disclosure relates to systems, devices, and related methods for retracting tissue.
Technological developments have given users of medical systems, devices, and methods, the ability to conduct increasingly complex procedures on subjects. The removal of tissue in, for example, a subject's gastrointestinal tract, is a type of procedure in which difficulties may arise. One such area of difficulty involves removing a lesion from tissue. In order to remove the lesion, the user may retract tissue at or around the lesion. This retraction may enable the user to clearly observe a cutting plane for removing the lesion. Having this visualization may aid in preventing unwanted incision errors, such as severing vessels. The visualization also may aid in ensuring that as much of or all of the lesion is removed.
Endoscopic Submucosal Dissection (ESD) is a technique for removing polyps and tumors from the gastrointestinal tract. There are three distinct steps associated with an ESD technique, including injection at the target tissue site, cutting circumferentially around the target tissue, and dissecting beneath the submucosa of the lesion. ESD allows for the target tissue to be removed en bloc, improving the accuracy of the histopathologic assessment. Physicians are also able to resect deeper into the tissue, possibly removing cancers that have invaded deeper into the tissue layers. Since an electrocautery device is used to resect tissue (as opposed to a snare), physicians who conduct ESD may remove lesions of many sizes and shapes.
One limiting factor to ESD is in the complexity of the procedure. ESD may result in tissue wall perforation if sufficient elevation and separation of the tissue layers is not achieved. The risk to patients deters many physicians from using ESD. Some physicians are willing to reposition patients to leverage gravity as they conduct ESD. However, older and larger patients are difficult to reposition, and doing so could further compromise the procedure. One current technique involves utilizing a cap to help position an endoscope under a tissue flap, and to use a hybrid cutting device with injection capabilities. However, this may position the optics of the endoscope immediately adjacent the tissue, resulting in poor recognition (poor visualization) of the endoscope location relative to the rest of the lumen or larger tumors. Such techniques also may result in poor visualization of tissue tension achieved, and poor visualization of tissues impeding the dissection process.
Aspects of the disclosure relate to, among other things, systems, devices, and methods for retracting tissue. Each of the aspects disclosed herein may include one or more of the features described in connection with any of the other disclosed aspects.
A system may include a retractor movable between a radially-collapsed configuration and a radially-expanded configuration, a retraction tool having a tissue-engaging element and an anchor-engaging element, and a first member configured to form a releasable coupling with the anchor-engaging element at each of a plurality of spaced apart positions.
The system includes an overtube having a lumen configured to receive an endoscope, wherein the retractor is disposed at or adjacent to a distal end of the overtube. The first member is a rail that provides rigidity to the retractor when the retractor is in the radially-expanded configuration. The retractor includes the first member. The plurality of spaced apart positions are longitudinally spaced apart positions. The plurality of spaced apart positions include radially spaced apart positions. The retraction tool includes an elastic tether coupling the tissue-engaging element with the anchor-engaging element. The anchor-engaging element is a hook, and the first member includes a plurality of spaced apart rings each configured to receive the hook. One of more of the rings is biased radially outwardly from the first member. The anchor-engaging element includes hooks or loops, the first member includes a support having hooks or loops, and the anchor-engaging element and the support form a Velcro-type fastener. The first member is adapted to hold a sliding position of the anchor-engaging element. The sliding position of the anchor-engaging element is incremental and includes a plurality of teeth. The overtube includes one or more helical tracks having balls disposed therein, wherein movement of the balls through the one or more helical tracks drives the overtube longitudinally relative to the endoscope. The system further includes a handle configured to drive the balls through the one or more helical tracks, wherein rotation of the handle in a first direction causes the overtube to move distally relative to the endoscope, and rotation of the handle in a second direction opposite of the first direction causes the overtube to move proximally relative to the endoscope. The system further includes the endoscope, wherein the endoscope includes one or more helical tracks having a corresponding pitch as the one or more helical tracks of the overtube.
A system may include an overtube having a lumen configured to receive an endoscope, a retractor at or adjacent to a distal end of the overtube, the retractor being movable between a radially-collapsed configuration and a radially-expanded configuration, and a tool having a shaft and a tissue-engaging element coupled to a distal end of the shaft by a tether, wherein the distal end of the shaft is sloped relative to a proximal end of the shaft.
The tether is an elastic tether.
A method of treating a patient may include radially expanding a retractor while the retractor is adjacent to a target area in a body lumen of the patient, grasping tissue with a tissue-engaging element of a retraction tool, and tensioning the tissue by securing an anchor-engaging element, coupled to the tissue-engaging element, to a first anchor element of a plurality of spaced apart anchor elements.
The method further includes adjusting the tension of the tissue by securing the anchor-engaging element to a second anchor element of the plurality of spaced apart anchor elements. Before the radially expanding step, the method includes: positioning a distal end of an endoscope adjacent to the target area in the body lumen; and extending an overtube including the retractor over the endoscope so that the retractor is adjacent to the target area.
It may be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the present disclosure and together with the description, serve to explain the principles of the disclosure.
The present disclosure is drawn to systems, devices, and methods for retracting tissue. Reference will now be made in detail to aspects of the present disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numbers will be used through the drawings to refer to the same or like parts. The term “distal” refers to a portion farthest away from a user when introducing a device into a patient. By contrast, the term “proximal” refers to a portion closest to the user when placing the device into the patient. The term “retraction” may refer, for example, to positioning tissue to expose and/or visualize a cutting area or plane for removing the tissue. As used herein, the terms “comprises,” “comprising,” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term “exemplary” is used in the sense of “example,” rather than “ideal.”
Embodiments of the present disclosure may be used for providing traction on target tissue in an endo-luminal space. In particular, some embodiments combine a luminal retraction (space-creating) apparatus with a tissue retraction device. The luminal retraction apparatus may include a retraction mechanism (e.g., a tissue clip), a scaffold structure (retractor) delivered by an endoscope, and at least one rail for translation of the retraction mechanism. The retractor may be delivered over the endoscope to the target tissue site. The overall system may include a mechanism for coupling a retraction mechanism, such as a tissue clip, to one or more anchored points on the rail. The retractor may be movable between open (expanded) and closed (retracted) states, and may include at least one opening (open access feature) that may be positioned adjacent to a target site. The retractor could be metallic, plastic, or include a shape memory metal, a shape memory polymer, a polymer, or any combination of materials. The retractor also may include a mechanism for anchoring to tissue at the desired site. This anchoring feature could take the form of barbs, hooks, spirals, outward radial force, and any other feature to secure the retractor to tissue.
The tool inserted through tool lumens 106a and 106b may be any tool known to one of skill in the art. For example, the tool may include a grasper, a forceps, a snare, a scissor, a knife, a dissector, a clamp, an endoscopic stapler, a tissue loop, a clip applier, a suture-delivering instrument, or an energy-based tissue coagulator or cutter. Although two tool lumens 106a and 106b are illustrated, it should be appreciated that a system with more than two tool lumens or with only one tool lumen may be utilized. Additionally, endoscope 1200 itself may include one or more lumens for delivering working instruments and tools to a treatment site.
System 100 includes a reversibly-expandable retractor 150, as shown in
Distal coupler 199 is shown in the shape of a ring, although it may be virtually any shape desirable to one of skill in the art, such as a cone, a hemisphere, a sphere, and the like. Distal coupler 199 may include a port 199a for passage of endoscope 1200 beyond the distal end of system 100. Alternatively, distal coupler 199 may not include a port 199a, and distal coupler 199 may be closed. In some embodiments, proximal coupler 198 may be moved toward distal coupler 199, distal coupler 199 may be moved toward proximal coupler 198, or both couplers 198 and 199 may be moved toward each other, to reduce their distance apart and force retractor elements 151-154 radially outward from the collapsed position shown in
In some embodiments, retractor 150 may be reversibly stabilized by stiffening an otherwise flexible arrangement of retractor 150. The stabilization of retractor 150 may, in some embodiments, include a stabilizer having, for example, an at least substantially-rigid rail 175 to support the expanded retractor 150. Rail 175 may be substantially rectangular in cross-section, substantially circular in cross-section, or of other cross-sectional shapes. Rail 175 may include a same material or a stiffer material than retractor elements 151-154. Rail 175 may limit deflection of the distal end of system 100, which would otherwise occur by pressure exerted on the distal end by a body lumen wall. Rail 175 may be a straight component comprising a rigid material, for example stainless steel or another metal or alloy, that is slidable in and out of overtube 105. A ring or other sliding member 175a may slide along rail 175 (or any other rail described with respect to the embodiments and examples herein). Sliding member 175a may frictionally engage with rail 175 so that it has an infinite or near-infinite number of positions. Alternatively, sliding member 175a may slide incrementally and rest in various grooves or notches positioned along rail 175. A tether 806 and anchor 810 (described in further detail below) may be coupled to sliding member 175a. Alternatively, any other suitable tool, anchor, or engagement element described herein may be attached to sliding member 175a for anchoring and/or engaging tissue.
A bridge member 144 may be utilized to add stability to retractor 150. For example, retractor 150 may include bridge member 144 configured to maintain a desired orientation of the retractor elements during the expansion. As shown in
Retractor elements 151-154 each may have a covering (151a, 152a, 153a, 154a), which adds bulk to the respective retractor elements 151, 152, 153, 154 by increasing their effective cross-sectional diameter. Coverings 151a, 152a, 153a, 154a (
A covering or cover 1170 (shown in
The use of system 100 will now be described with reference to removing a lesion, such as a polyp, from a body lumen wall. Turning first to
Once expanded, endoscope 1200 may be drawn proximally between couplers 198 and 199 to provide additional work space, and to provide a view of the work space (via the optics of endoscope 1200). Targeted polyp 404 (or other tissue) may be placed circumferentially between two circumferentially adjacent retractor elements. Then, tissue clips may be opened, closed, rotated, and coupled to target polyp 404, at which point cutting and injection devices may be used to perform, e.g., endoscopic submucosal dissection (ESD). As discussed further below, a tether may be used to selectively couple a tissue clip to rail 175 at different locations (e.g., longitudinal positions), allowing for users to change the angle of traction being generated on the grasped tissue. Thus, the following
Anchors 802 may be used in conjunction with a tissue clip 800. Tissue clip 800 may include an engagement element 804, an anchor 810 for embedding into or otherwise grasping tissue, and a tether 806 for linking engagement element 804 to anchor 810. Engagement element 804 may be a hook or other similar structure for engaging with anchors 802. That is, engagement element 804 and anchor 802 may have corresponding mating features. In one example, engagement element 804 and anchor 802 may be magnetically attracted to one another (via exposure of opposite poles). In another embodiment, engagement element 804 and anchor 802 each may include tacky surfaces. Anchor 810 may include, for example, a grasping element formed by jaws. It is contemplated that the jaws may move between an open position for receiving tissue and a closed position for grasping the received tissue. Any suitable positioning instrument (not shown) may be configured to actuate the jaws between the open position and the closed position. Anchor 810 also may include a coil with a sharp tip to embed into tissue, a barb, a spike, or another suitable tissue grasping element. Tether 806 may include a wire, a cord, a cable, an elastic band (e.g., a rubber band), a spring (e.g., a helical tension spring), a suture, a high carbon spring wire, a braided or wound filament, stainless steel, nitinol, spring steel, music wire, muscle wire, and/or any other suitable elongate member. Tether 806 may be metallic, polymeric, or a combination of metallic and polymeric.
An operator may use grasper 840 or another suitable tool to adjust the longitudinal, circumferential, and/or radial position of engagement element 804, and thus adjust the tension or orientation of the tissue grasped by anchor 810, by coupling engagement element 804 to different anchors 802.
An operator may use grasper 840 (shown in
In the embodiment shown in
Overtube 105 and endoscope 1200 are shown in
It will be apparent to those skilled in the art that various modifications and variations may be made in the disclosed devices and methods without departing from the scope of the disclosure. Other aspects of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the features disclosed herein. It is intended that the specification and examples be considered as exemplary only.
This application claims the benefit of priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application Ser. No. 62/715,521, filed on Aug. 7, 2018, which is incorporated by reference in its entirety for all purposes.
Number | Date | Country | |
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62715521 | Aug 2018 | US |