Plication anchoring devices and systems, hemostasis clips and systems, and methods for using same

Abstract

Plication systems and devices when arranged in an open configuration have one or more windows into which tissue of, for example, a tubular organ may be invaginated. The invaginated tissue may be secured in the window when the plicator system transitions to a closed configuration, which pushes needles into the open window, thereby piercing the invaginated tissue and holding the plication system, and any devices (e.g., a stent) coupled thereto in place within the tubular organ for a short (e.g., hours) or long (e.g., weeks, months, or years) period of time. Additionally, or alternatively, the plication systems may be used to close an opening in the tubular organ and / or attach two open ends of the tubular organ together.

Description

202201. PT7W0PLICATION ANCHORING DEVICES AND SYSTEMS, HEMOSTASIS CLIPS AND SYSTEMS, AND METHODS FOR USING SAMERELATED APPLICATION

[0001] This patent application is a NON-PROVISIONAL patent application claiming priority to U.S. Provisional Patent Application No. 63 / 720,135, filed on 13 November 2024 and entitled “SYSTEMS, DEVICES, AND METHODS FOR USING PLICATION DEVICES AND / OR PLICATION SYSTEMS FOR GASTRO-INTESTINAL APPLICATIONS AND / OR PROCEDURES,” which is incorporated in its entirety herein.FIELD OF THE DISCLOSURE

[0002] The present disclosure relates generally to medical devices and, in particular to plication anchoring devices, systems, and methods related thereto for use in gastrointestinal procedures. In addition, the present disclosure relates to hemostasis clips, systems including hemostasis clips and methods related thereto for use in gastrointestinal procedures.BACKGROUND OF THE DISCLOSURE

[0003] The gastrointestinal (Gl) tract includes, among other organs, various tubular, luminal, and / or hollow organs and / or tissues (collectively "tubular organ(s)") including the esophagus, stomach (e.g., cardia and / or pylorus) small intestine, and large intestine (colon, rectum, anus). The small and large intestine may be collectively referred herein to as "intestine" or "intestines." Gl medical interventions are essential for treating a wide range of Gl ailment conditions related to the Gl tract, including various illnesses, diseases, and disorders.

[0004] Gl ailment conditions may range from chronic or acute conditions necessitating emergency Gl medical intervention to non-emergency conditions in which a patient elects a Gl medical intervention. For example, emergency (e.g., acute or chronic) Gl ailment conditions, often life-threatening, may include Gl laceration, severe bleeding, and sometimes severe acid reflux; non-emergency Gl ailment conditions may include non-bleeding Gl ulceration, weight loss management, and minor acid reflux. In various instances, a non-emergency Gl ailment condition may pose a risk of becoming an emergency Gl ailment condition. For example, non-bleeding Gl ulceration poses a risk of bleeding or re-bleeding necessitating emergency Gl medical intervention.

[0005] Gl medical interventions may beneficially be noninvasive and address both emergency and non-emergency Gl ailment conditions. Noninvasive Gl medical202201. PT7W0interventions often involve endoscopic treatments utilizing Gl plication of a tubular organ of the Gl tract, such as a portion of the esophagus, stomach, and / or intestines. Gl plication is a surgical procedure in which tissue of the Gl tract is invaginated (folded inward) using a plication anchor to secure (anchor) the tissue and facilitate performance of a particular Gl medical intervention, such as stent placement, hemostatic treatment, and tissue perforation (e.g., ulcer perforation) repair. Gl plication procedures may include, for example, endoluminal gastroplication (ELGP) and transoral incisionless fundoplication (TIF).

[0006] Traditional Gl plication procedures, while generally effective, may suffer from various issues, including challenges related to gastric and / or air obstruction and / or challenges related to plication anchor(s) removal. Gastric and / or air blockage may result from stenosis or stricture (narrowing of Gl tract) due to obstruction by a Gl plication anchor. Release and removal of a Gl plication anchor is typically achieved using surgical techniques which may be fraught with obstacles including difficulty in locating the anchor, perforation or tearing of the organ tissue, potential nerve injury, and potential anesthesia complications.SUMMARY OF THE DISCLOSURE

[0007] Various details of the present disclosure are hereinafter summarized to provide a basic understanding. This Summary is not an exhaustive overview of the disclosure and is neither intended to identify certain elements of the disclosure nor to delineate the scope of the disclosure. Instead, the primary purpose of this Summary is to present various concepts of the disclosure in a simplified form prior to the more detailed description that is presented hereinafter in the Detailed Description.

[0008] The present disclosure provides plicator devices and systems, and methods related thereto. The plicator anchoring devices may be configured for implantation within a tubular organ of the gastrointestinal (Gl) tract.

[0009] Plication anchor systems configured for implantation within a tubular organ may include a plication anchor device and an adaptor configured for mechanical attachment to the plication anchor device to a plication anchor delivery device such as an endoscope. The plication anchor device may include an outer component with a first lumen, a plurality of needles, and a retention mechanism and an inner component including a second lumen and a plurality of projections extending from an outer surface of the inner component, each of the plurality of projections being arranged and configured to engage with the retention mechanism. At times, a portion of the inner component may be disposed within the outer component so that the first lumen aligns with the second lumen, thereby generating a central lumen for the plicator anchor device, the inner component, when disposed within the outer component may form a window with an open area to into which a portion of a tubular organ202201. PT7W0tissue may be invaginated (via, for example, application of negative pressure) when the plication anchor device is implanted into the tubular organ and the plication anchor device is in an open configuration, and the plication anchor device may be configured to translate from the open configuration to a closed configuration as the inner component is pushed toward outer component, thereby pushing the plurality of needles the window and piercing the invaginated a tissue of the tubular organ therein with the needles so that the plication anchor device is securely implanted within the tubular organ.

[0010] The plication anchor systems and / or or component(s) thereof may have an outer diameter of 8 mm to 30 mm and / or a length of 8 mm to 40 mm. The plication anchor systems and / or or component(s) thereof may comprise a metal, a nickel-titanium alloy, plastic, a biodegradable / bioabsorbable, or a non-biodegradable polymer. Once placed within a tubular organ, the plication anchor device may disengage, or otherwise separate from, the adaptor so that the adaptor and, on some occasions, delivery device may be removed from the patient’s body.

[0011] In some examples, the outer component may include one or more barbs extending therefrom. The barbs may be configured to attach (removably or permanently) a stent to the plication anchor device and / or plication anchor delivery device. In some cases, a portion of the outer component may be placed within a lumen of the stent with the barbs in a retracted state. Once the stent is in position, the barbs may be extended from the outer component to that the press into and engage a portion of the interior surface of the stent and attach the stent to the plication anchor device and / or plication anchor delivery device. The stent may be, for example, a stent for the Gl tract or a portion thereof (e.g., esophagus, intestine, colon, etc.) and the plication anchor device may act to removably hold the stent in place within the Gl tract. The stents used with the systems and devices disclosed herein include, but are not limited to, esophageal stents, colonic stents, duodenal stents, endobariatric stents or sleeves, and other stents configured for use within the Gl tract.

[0012] In some examples, a suture may be in communication with at least one of the inner component and the outer component so that application offeree to the suture may act to pull the outer component toward the inner component thereby pushing the plurality of needles into the window and piercing the invaginated tubular organ tissue therein with the needles so that the plication anchor device is securely implanted within the tubular organ. The force may be applied to the suture manually or via a tool (e.g., a dial or button positioned on an endoscope).

[0013] The plication anchor devices disclosed herein may include an outer component with a first lumen, a plurality of needles, and a retention mechanism and an inner component with a second lumen and a plurality of projections extending from an outer surface of the202201. PT7W0inner component, each of the plurality of projections being arranged and configured to engage with the retention mechanism. A portion of the inner component may be disposed within the outer component so that the first lumen aligns with the second lumen, thereby generating a central lumen for the plicator anchor device. Additionally, or alternatively, the inner component may be disposed within the outer component to form a window with an open area to into which a portion of a tissue of the tubular organ may be invaginated when the plication anchor device is implanted into the tubular organ and the plication anchor device is in an open configuration. The plication anchor device may be configured to translate from the open configuration to a closed configuration as the inner component is pushed toward outer component, thereby pushing the needles into the window and piercing the invaginated tubular organ tissue therein with the needles so that the plication anchor device is securely implanted within the tubular organ.

[0014] In another embodiment, the present disclosure provides a method for implanting a plication anchor system into a tubular organ of a patient. The method includes positioning the plication anchor system within the tubular organ, applying negative pressure to the plication anchor system, thereby invaginating tissue of the tubular organ into a window of the plication anchor system, and actuating the plication anchor system to secure the tissue of the tubular organ within the window. In some cases, an assembly of a plication anchor system and a stent may be implanted into the tubular organ of a patient, wherein the assembly is positioned within the tubular organ so that the stent extends along the tubular organ in a desired fashion. Then, negative pressure may be applied to the plication anchor system, thereby invaginating tissue of the tubular organ into a window of the plication anchor system and actuating the plication anchor system to secure the tissue of the tubular organ within the window in the same manner. The secured plication anchor system may then act to hold the stent in place within the tubular organ.

[0015] On some occasions, actuating the plication anchor system may include applying force to a suture in communication with at least one of the inner component and the outer component, wherein application of the force pulls the outer component toward the inner component thereby pushing the plurality of needles into the window and piercing the invaginated tubular organ tissue therein with the needles so that the plication anchor device is securely implanted within the tubular organ.

[0016] Methods of implanting an assembly of a stent into a tubular organ of a patient may include positioning an assembly of the stent and a plication anchor system within the tubular organ, applying negative pressure to the plication anchor system, thereby invaginating tissue of the tubular organ into a window of the plication anchor system, and actuating the plication202201. PT7W0anchor system to secure the tissue of the tubular organ within the window and the stent within the tubular organ.

[0017] In some embodiments, an assembly of a stent and one or more of the plication anchor devices and / or systems disclosed herein may be used to treat and / or protect tubular organ tissue following, for example, trauma, injury, and / or surgery to, for example, remove a segment of tubular organ and / or diseased tissue therefrom.

[0018] Any combinations of the various embodiments and implementations disclosed herein can be used in a further embodiment, in any combination, consistent with the disclosure. These and other aspects and features can be appreciated from the following description of certain embodiments presented herein in accordance with the disclosure and the accompanying drawings and claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The present disclosure is illustrated by way of example, and not limitation, in the figures of the accompanying drawings in which:

[0020] FIG. 1 A1 provides a schematic, front-side view of a plication anchor system comprising a plication anchor device in an open configuration, in accordance with one or more embodiments of the present disclosure.

[0021] FIG. 1A2 provides a schematic, right-side view of the plication anchor system of FIG. 1 A1 , in accordance with one or more embodiments of the present disclosure.

[0022] FIG. 1 B1 provides a schematic, perspective view of a plication anchor device, in accordance with one or more embodiments of the present disclosure.

[0023] FIG. 1B2 provides a schematic, front-side view of a plication anchor device in an open configuration, in accordance with one or more embodiments of the present disclosure.

[0024] FIG. 1B3 provides a schematic, right-side view of the plication anchor device of FIG. 1 B2, in accordance with one or more embodiments of the present disclosure.

[0025] FIG. 1B4 provides a schematic, cross-sectional view of the plication anchor device of FIG. 1 B2, in accordance with one or more embodiments of the present disclosure.

[0026] FIG. 2A1 provides a schematic, front-side view of the plication anchor system of FIG. 1A1 comprising the plication anchor device in a closed configuration, in accordance with one or more embodiments of the present disclosure.

[0027] FIG. 2A2 provides a schematic, right-side view of the plication anchor system of FIG. 2A1 comprising the plication anchor device in a closed configuration, in accordance with one or more embodiments of the present disclosure.202201. PT7W0

[0028] FIG. 2B1 provides a schematic, perspective view of a plication anchor device in a closed configuration, in accordance with one or more embodiments of the present disclosure.

[0029] FIG. 2B2 provides a schematic, front-side view of a plication anchor device in a closed configuration, in accordance with one or more embodiments of the present disclosure.

[0030] FIG. 2B3 provides a schematic, right-side view of the plication anchor device of FIG. 2B2, in accordance with one or more embodiments of the present disclosure.

[0031] FIG. 2B4 provides a schematic, cross-sectional right-side view of the plication anchor device of FIG. 2B3, in accordance with one or more embodiments of the present disclosure.

[0032] FIG. 2B5 provides a schematic, cross-sectional front-side view of the plication anchor device of FIG. 2B3, in accordance with one or more embodiments of the present disclosure.

[0033] FIG. 3A provides a schematic front-side view of an adaptor, in accordance with one or more embodiments of the present disclosure.

[0034] FIG. 3B provides a schematic right-side view of an adaptor, in accordance with one or more embodiments of the present disclosure.

[0035] FIG. 3C provides a schematic, isometric view of an adaptor, in accordance with one or more embodiments of the present disclosure.

[0036] FIG. 4A provides a schematic, cross-sectional right-side view of a plication anchor device closure mechanism, in accordance with one or more embodiments of the present disclosure.

[0037] FIG. 4B provides a first isometric schematic, cross-sectional right-side view of the plication anchor device closure mechanism of FIG. 4A, in accordance with one or more embodiments of the present disclosure.

[0038] FIG. 4C provides a second cross-sectional right-side view of plication anchor device closure mechanism of FIG. 4A, in accordance with one or more embodiments of the present disclosure.

[0039] FIG. 5A provides a schematic, front-side view of a stent placement system with a closed plication anchor device, in accordance with one or more embodiments of the present disclosure.

[0040] FIG. 5B provides a schematic, cross-sectional front-side view of the stent plicator system with a closed plication anchor device of FIG. 5A, in accordance with one or more embodiments of the present disclosure.202201. PT7W0

[0041] FIG. 5C provides a schematic, cross-sectional front-side view of a stent plicator system with a closed plication anchor device and released from the adapter of 5B, in accordance with one or more embodiments of the present disclosure.

[0042] FIG. 5D provides a schematic, cross-sectional front-side view of the stent plicator system of FIG. 5C positioned within a tubular organ, in accordance with one or more embodiments of the present disclosure.

[0043] FIG. 6A provides a schematic, perspective view of a hemostasis clip, in accordance with one or more embodiments of the present disclosure.

[0044] FIG. 6B provides a schematic, side view of the hemostasis clip of FIG. 6A, in accordance with one or more embodiments of the present disclosure.

[0045] FIG. 6C provides a schematic, top view of the hemostasis clip of FIG. 6A, in accordance with one or more embodiments of the present disclosure.

[0046] FIG. 7A provides a schematic, side view of a deployment adapter, in accordance with one or more embodiments of the present disclosure.

[0047] FIG. 7B provides a schematic, top view of the deployment adapter of FIG 7A, in accordance with one or more embodiments of the present disclosure.

[0048] FIG. 7C provides a schematic, perspective view of the deployment adapter of FIG 7A, in accordance with one or more embodiments of the present disclosure.

[0049] FIG. 8A provides a schematic, top view an assembly including the hemostasis clip of FIG. 6A in an open configuration, in accordance with one or more embodiments of the present disclosure.

[0050] FIG. 8B provides a schematic, side view of the assembly of FIG. 8A, in accordance with one or more embodiments of the present disclosure.

[0051] FIG. 8C provides a schematic, perspective view of the assembly of FIG. 8A, in accordance with one or more embodiments of the present disclosure.

[0052] FIG. 8D provides a side view of the assembly of FIG. 8A with a suture therein, in accordance with one or more embodiments of the present disclosure.

[0053] FIG. 8E provides a bottom view of a deployment ring of the assembly of FIG. 8D with suture thread therethrough in a button-like fashion, in accordance with one or more embodiments of the present disclosure.

[0054] FIG. 8F provides a front view of the assembly of FIG. 8D, in accordance with one or more embodiments of the present disclosure.

[0055] FIG. 8G provides a schematic, side view of the assembly of FIG. 8A and / or 8D with the hemostasis clip thereof in a closed configuration, in accordance with one or more embodiments of the present disclosure.202201. PT7W0

[0056] FIG. 8H provides a schematic, top view of the assembly of FIG. 8G, in accordance with one or more embodiments of the present disclosure.

[0057] FIG. 81 provides a schematic, perspective view of assembly FIG. 8G, in accordance with one or more embodiments of the present disclosure.

[0058] FIG. 8J provides a schematic, exploded view of the assembly of FIG. 81, wherein the hemostasis clip has been released from the delivery device, in accordance with one or more embodiments of the present disclosure.

[0059] FIG. 9A provides a schematic, top view of a tubular organ with the assembly FIG.8A or 8D positioned therein with the hemostasis clip thereof in an open configuration, in accordance with one or more embodiments of the present disclosure.

[0060] FIG. 9B provides a schematic, top view of a tubular organ with the assembly FIG.8A or 8D positioned therein with the hemostasis clip thereof in a closed configuration, in accordance with one or more embodiments of the present disclosure.

[0061] FIG. 9C provides a schematic, top view of a tubular organ with the hemostasis clip in a closed configuration positioned therein after the hemostasis clip has been released from the hemostasis clip delivery device, in accordance with one or more embodiments of the present disclosure.

[0062] Throughout the drawings, the same reference numerals, and characters, unless otherwise stated, are used to denote like features, elements, components, or portions of the illustrated embodiments. Moreover, while the subject disclosure will now be described in detail with reference to the drawings, the description is done in connection with the illustrative embodiments. It is intended that changes and modifications can be made to the described embodiments without departing from the true scope and spirit of the subject disclosure as defined by the appended claims.DETAILED DESCRIPTION OF THE DISCLOSURE

[0063] The present disclosure provides plication anchor devices (PADs) and systems, and methods for insertion, deployment, removal, and use related thereto. The plication anchor systems of the present disclosure may include a cylindrical-shaped PAD, a cylindricalshaped endoscope, and a cylindrical-shaped adaptor interposed between and mechanically coupled to the PAD and the endoscope. The adaptor and plication anchor device are located at the distal end of the endoscope.

[0064] The PAD and systems disclosed herein may be configured for placement and implantation of a PAD within a tubular organ of the Gl tract, such as the esophagus, stomach, colon, and / or intestines. The form factor of the PADs of the present disclosure202201. PT7W0may be beneficially configured for use in relatively small tubular organs, including pediatric, and / or relatively large tubular organs.

[0065] The PAD may be configured for side or perpendicular implantation to the tubular organ, such as by surgical implantation (e.g., sutures) and / or mechanical implantation via one or more tissue-attachment mechanisms (e.g., teeth, ribs, snaps, projections, and / or other closure mechanisms). The PADs of the present disclosure may be preferentially implanted into the tubular organ via, for example, endoscopy or laparoscopy; alternatively, the PADs may be implanted to the tubular organ via an open surgical procedure.

[0066] In various embodiments, the PADs of the present disclosure may be implanted in a tubular organ and secured therein by clamping and / or piercing the tissue thereof. A number (e.g., 1-5) of PADs may be placed in the tubular organ of a patient. The one or more PADs placed within a tubular organ and / or patient may depend on a variety of factors such as the tubular organ of implantation and the treatment to be provided, for example.

[0067] In an example treatment, the PADs of the present disclosure may be used to treat ulcer scaring and resulting stricture in which the PAD functions as both a means for repair, hemostasis, and scaffolding. After healing, the PAD may naturally slough off the tubular organ tissue and pass through the patient's digestive tract or otherwise removed surgically.

[0068] In another example treatment, the PADs and systems may be used to provide distal anchoring of gastric stents (e.g., self-expanding metallic stents (SEMS) and / or plastic) and / or sleeves. Such anchoring can minimize stent placement complications, such as migration, obstruction, perforation, and bleeding. With aid of an attached endoscope, the PADs may be placed in a tubular organ and secured to the tissue thereof prior to placement of a stent. Long term anchoring may minimize complications like compression and necrosis of the tissue. After treatment, the PADs may naturally slough off and pass through the patient's digestive tract or otherwise removed surgically.

[0069] Beneficially, the PADs disclosed herein may additionally comprise a central lumen that, together with the side / perpendicular implantation, permits normal, unimpeded passage of fluid and other substances (e.g., food, waste, etc.) through the PAD in a manner consistent with normal functioning of the tubular organ.

[0070] It is to be appreciated that while the present disclosure describes the plication anchor systems and devices for use in a tubular organ of the Gl tract, the plication anchor systems and devices disclosed herein may be used in any tubular, luminal, and / or hollow organs of a mammal (e.g., human) in which the PADs described herein can be implanted, such as the urethra, fallopian tube, and the like, without departing from the scope of the present disclosure.202201. PT7W0

[0071] Embodiments of the present disclosure will now be described in detail below with reference to the accompanying figures. Consistent reference numbers identify similar elements across different figures. This Detailed Description includes specific technical details to provide a more thorough understanding of the subject matter. However, those skilled in the art will recognize that the disclosed embodiments can be implemented and practiced without all the specific details provided. Some well-known features are not described in detail to keep the description focused and accessible. Additionally, the scale of elements shown in the figures may be adjusted without affecting the scope of this disclosure.

[0072] Turning now to the figures, FIGS. 1A1 and 1A2 illustrate a plication anchor system according to one or more embodiments of the present disclosure. FIG. 1A1 is a schematic, front-side view of plication anchor system 100 comprising PAD 105 in an open configuration, the back-side view (not shown) being a mirror image thereof; FIG. 1A2 is a schematic, rightside view of the plication anchor system of FIG. 1 A1 , the left-side view (not-shown) being a mirror image thereof.

[0073] Referring to FIGS. 1A1 and 1A2, system 100 includes PAD 105, endoscope or anchor delivery device 115, and adaptor 110 interposing and mechanically coupled to PAD 105 and endoscope / anchor delivery device 115. Open PAD 105, as described in greater detail hereinbelow, includes proximal end 105a and distal end 105b and a lumen (not shown) therethrough.

[0074] FIGS. 1B1, 1B2, 1B3, and 1B4 are schematic illustrations of the open configuration of PAD 105. FIG. 1B1 is a schematic, perspective side-view of PAD 105 in an open configuration; FIG. 1B2 is a schematic, front-side view PAD 105 in an open configuration, the back-side view (not shown) being a mirror image thereof; FIG. 1B3 is a schematic, rightside view of PAD 105 of FIG. 1B2, the left-side view (not-shown) being a mirror image thereof; and FIG. 1B4 is a schematic, cross-section view of the right side of PAD 105 of FIG.1B3.

[0075] As shown, PAD 105 includes proximal end 105a and distal end 105b. Distal end 105b includes inner component 202b and outer component 202a. While in the open position, the inner component 202b extends distally from outer component 202a. In its open configuration, PAD 105 includes window 210 for invagination of tissue of a tubular organ, such as via vacuum (e.g., applying negative pressure) or other suction mechanism and / or pressing the tissue into opening 210. While in the open position, needles 205 (five shown) are retracted into distal end 105b, specifically outer component 202b. When PAD 105 translates to the closed position, as detailed below, needles 205 are pushed proximally and are received into window 210 so that they may pierce and secure tissue invaginated within window 210. PAD 105 further includes at least two projections, or barbs, 215 positioned202201. PT7W0along distal end 105b, which are retracted in the shown open position and pushed out in the closed position (see, e.g., FIGS. 2B1-2B4). Barbs 215 may be used to secure stents or sutures to implantation into a tubular organ. Barbs 215 may include, for example, a threaded / screw mechanism, a friction and / or press fit mechanism, an annular snap, a J-lock mechanism and / or a latching mechanism. Inner component 202b may further include one or more ramp feature(s) 240 that, on some occasions may encircle inner component 202b.

[0076] As can be seen in FIG. 1B4, PAD 105 incudes locking and / or retention mechanism 220 for telescoping inner component 202b into and out of outer component 202a and holding inner component 202b in place relative to outer component 202a. Retention mechanism 220 may include, for example, an extension 245 configured to engage with a corresponding tab 247 of inner component 202b to maintain a position of the inner component 202b with regard to the outer component 202a when PAD 105 is closed as shown in, for example, FIG. 2B4. In some embodiments, outer component 202a may include an elastic band 225 that encircles outer component and works to apply compressive force to PAD 105 to, for example, prevent deformation thereof and / or unintentional disengagement of inner component 202b (e.g., tab 247) from extension 245.

[0077] FIGS. 2A1 and 2A2 illustrate a plication anchor system according to one or more embodiments of the present disclosure. FIG. 2A1 is a schematic, front-side view of plication anchor system 100 comprising PAD 105 in a closed configuration, the back-side view (not shown) being a mirror image thereof; FIG. 2A2 is a schematic, right-side view of the plication anchor system of FIG. 2A1, the left-side view (not-shown) being a mirror image thereof.

[0078] As shown in FIGS. 2A1 and 2A2, and with continued reference FIGS. 1A1, 1A2, and 2A1-1B4, system 100 includes PAD 105, endoscope / anchor delivery device 115, and adaptor 110 interposing and mechanically coupled to PAD 105 and endoscope / anchor delivery device 115. Closed PAD 105, as described in greater detail hereinbelow, includes proximal end 105a and distal end 105b.

[0079] FIGS. 2B1 , 2B2, 2B3, 2B4, and 2B5 are schematic illustrations of the closed configuration of PAD 105. FIG. 2B1 is a schematic, perspective view of PAD 105 in a closed configuration; FIG. 2B2 is a schematic, al front-side view PAD 105 in a closed configuration, the back-side view (not shown) being a mirror image thereof; FIG. 2B3 is a schematic, c right-side view of PAD 105 of FIG. 2B2, the left-side view (not-shown) being a mirror image thereof; FIG. 2B4 a schematic, cross-sectional right-side view of PAD 105 of FIG. 2B3, the left-side view (not shown being a mirror image thereof; FIG. 2B5 a schematic, cross-sectional front-side view of PAD 105 of FIG. 2B3, the back-side view (not shown being a mirror image thereof.202201. PT7W0

[0080] As shown, PAD 105 includes proximal end 105a and distal end 105b. Distal end 105b includes inner component 202b and outer component 202a. While in the closed position, the inner component 202b extends into the proximal end 105a from outer component 202a, so that needles 205 thereby extending into window 210 (see FIG. 1B3) to pierce invaginated tissue with needles 205. That is, when PAD 105 is the closed position needles 205 are received into window 210 for securing the tissue within window 210. PAD 105 further includes at least two projections, or barbs, 215 positioned along proximal end 105a, which are pushed away from the body of PAD 105 when, for example, pushed outward by ramp feature(s) 240 as inner component 202b telescopes into outer component 202a as PAD 105 closes and / or is closed as shown in, for example, FIGs. 2A1, 2B2, and 2B5. Barbs 215 may be used to secure devices (e.g., stents or sutures) thereto for implantation into a tubular organ, wherein PAD 105 is configured to hold the secured device in place within the tubular organ. Barbs 215 may include, for example, a threaded / screw mechanism, a friction and / or press fit mechanism, an annular snap, a J-lock mechanism and / or a latching mechanism, as previously described.

[0081] As can be seen in FIG. 2B4, PAD 105 may be held in a closed configuration when inner component 202b is telescoped into outer component 202b via engagement between locking and / or retention mechanism 220 and, in particular extension 245 with tab 247 as shown. Elastic band 225 may be configured to maintain engagement between extension 245 and tab 247 when in situ.

[0082] FIGS. 3A-3C illustrate a plication anchor for attachment to a PAD and an endoscope according to one or more embodiments of the present disclosure. FIG. 3A is a schematic front-side view of adaptor 110, the back-side view (not shown) being a mirror image thereof; FIG. 3B is a schematic right-side view of adaptor 110, the left-side view (not shown) being a mirror image thereof; FIG. 3C is a schematic, isometric view of adaptor 110.

[0083] As shown, adaptor 110 includes a proximal connector 305 to achieve mechanical connection to the distal end of a PAD like PAD 105. The particular type and shape of proximal connector 305 is not considered to be particularly limited and may vary with various embodiments of the PAD in order to achieve connection and release thereof of the PAD in a tubular organ. The type and shape of adaptor 110 may include, for example, a threaded / screw mechanism, a friction and / or press fit mechanism, an annular snap, a J-lock mechanism and / or a latching mechanism. Adaptor 110 further includes distal connector 310 for attaching to a proximal end of an endoscope (not shown).

[0084] FIGS. 4A, 4B, and 4C illustrate a PAD closure mechanism 400, wherein FIG. 4A is a schematic, cross-sectional right-side view of PAD closure mechanism 400; FIG. 4B is a202201. PT7W0first isometric schematic, cross-sectional right-side view of PAD closure mechanism 400; and FIG. 4C is a second cross-sectional right-side view of PAD closure mechanism 400.

[0085] As shown, sutures 405 are connected (e.g., through holes as shown in FIG. 4C) to distal end 105b of the inner component 202b, extend through adaptor 110 and optionally, as shown, endoscope / anchor delivery device 115. A doctor or other certified individual places the plication anchor system into a tubular organ, with PAD 105 in an open configuration. Upon proper placement, PAD 105 invaginates tissue of interest and PAD 105 is deployed into the closed configuration. Specifically, sutures 405 are pulled through the endoscope (e.g., using a handle of endoscope / anchor delivery device 115) to allow extension 245 to engage with corresponding tab 247 of inner component 202b, thereby closing PAD 105 and clamping and / or piercing the tissue of the tubular organ invaginated into window(s) 210. Endoscope / anchor delivery device 115 and adaptor 110 may thereafter be detached from PAD 105 via, for example, releasing and retracting one end of suture 405 so PAD 105 may detach therefrom.

[0086] In one or more embodiments, the plication system of the present disclosure is used to place a stent in tubular organ, as shown in FIGs. 5A-5D, wherein FIG. 5A is a schematic, front-side view of stent placement system 500 with a closed PAD; FIG. 5B is a schematic, cross-sectional view of stent placement system 500 with a closed PAD; FIG. 5C is a schematic, cross-sectional front-side view of stent plicator system 500 with a closed PAD that has been released from the adapter 110; and FIG. 5D is a schematic, cross-sectional view of the stent plicator system of FIG. 5C positioned within a tubular organ.

[0087] Stent placement system 500 may include PAD 105, adaptor 110, endoscope / anchor delivery device 115, and a stent 505. In some embodiments, stent 505 may be a stent configured for use within the gastrointestinal tract of a patient, such as an esophageal stent, an intestinal stent, a bariatric stent, and / or a stent configured to reside within the large intestine and / or colon. Stent 505 may be attached to PAD 105 via one or more barbs 215 that extend away from PAD 105 and into stent 505 to hold stent 505 in place via, for example, friction and / or compression. In some cases, stent 505 may be placed in tubular organ on distal end 105b of PAD 105 in a closed configuration using PAD closure mechanism 400, as described above. When PAD 105 is closed, barbs 215 are pushed against stent 505 to hold, or retain, stent 505 in place relative to PAD 105. In some instances, barbs 215 extend into openings of the patter of stent 215 to prevent stent 505 from migrating from PAD 105 while it is being inserted into a tubular organ and / or after it is placed within the tubular organ.

[0088] As shown in FIG. 5D, following placement of an assembly of PAD 105 and stent 505 within a tubular organ 550, sidewalls of the tubular organ may be invaginated into202201. PT7W0windows 210 and held in place via clamping or otherwise reducing a size of windows 210 as described herein. Once PAD 105 is placed, stent 505 may extend along a length of tubular organ 550 to, for example, hold tubular organ 550 open and / or protect a trauma site on tubular organ that may have been caused by, for example, surgery and / or removal of a portion of the tubular organ.

[0089] Upon placement at a desired location, a removal device (not shown), may be used to alter the PAD 105 into the open configuration, thereby pushing retention mechanism 245 of PAD 105 outward to separate distal end 105b and proximal end 105a of PAD 105 and removing contact with barbs 215. In some instances, the removal device may be a balloon that is inserted through the endoscope / anchor delivery device 115 and adaptor 110 and inflated to alter PAD 105 into the open configuration.

[0090] FIGs. 6A-6C provide various views of a hemostasis clip 600 in a closed, or active, configuration, wherein FIG. 6A provides a perspective view, FIG. 6B provides a side view, and FIG. 6C provides a top view thereof. Hemostasis clip 600 may be configured for insertion into a tubular organ to, for example, hold two portions, or ends, of traumatized and / or severed tubular organ together following, for example, open surgery, lesion removal, injury, and / or removal of a segment of the tubular organ to, for example, remove cancerous or necrotic tissue.

[0091] Hemostasis clip 600 has a truncated cylindrical, or substantially semicylindrical (e.g., 185-320 degrees) shape with a central aperture, or lumen 635 comprising an upper lumen 635a and a lower lumen 635b configured to allow fluids and other materials (e.g., food, waste, etc.) to pass therethrough so that the tubular organ may continue to function. Hemostasis clip 600 includes a distal component 610 that includes a first portion of engagement mechanism 620 in the form of an array of ridges 645, a proximal component 615 that includes a second portion of engagement mechanism 620 in the form of an extension 640. Extension 640 may include a component (e.g., tab, rib, or button) (not shown) sized and positioned to mechanically engage with one or more of ridges of array of ridges 645 to, for example, hold, or lock proximal component 615 in place as it is translated toward distal component 610 as, for example, shown and described herein (see e.g., FIG.8A). Hemostasis clip 600 also includes an optional brace 625 configured to, for example, provide structural integrity to hemostasis clip 600 and prevent deformation thereof when in situ.

[0092] A portion of an interior edge of distal component 610 and a corresponding portion of an interior edge of proximal component 615 include a plurality of teeth, or tissue engagement mechanisms 630, configured to grasp and hold tissue captured therebetween when hemostasis clip 600 is in a closed, or partially closed, configuration, which may act to202201. PT7W0hold hemostasis clip 600 in place within a tubular organ when closed as shown in, for example, FIG. 6B.

[0093] Hemostasis clip 600 may be configured to fit onto and cooperate with a deployment device 700 as shown in FIGs. 7A-7C, wherein FIG. 7A is a side view, FIG. 7B is a top view, and FIG. 7C is a perspective view thereof. Deployment device 700 includes a body 710 with a recessed portion 720 configured to cooperate with hemostasis clip 600 so that hemostasis clip 600 may be attached thereto and portions of hemostasis clip 600 (e.g., proximal component 615) may articulate to transition hemostasis clip 600 from an open state as shown in, for example, FIGs. 8A and 8B to a closed state as shown in, for example, FIGs.6A-6C. Deployment device 700 further includes a set of tracks 715 configured to facilitate articulation of proximal component 615 toward distal component 610 as shown in, for example, FIG. 8G. Each track 715 terminates with a respective tab 725 configured to engage and hold a portion of hemostasis clip 600 as, for example, disclosed herein.Deployment device 700 further includes a coupling 730 configured to fit over, or otherwise couple to, a hemostasis clip 600 deployment device (e.g., endoscope / anchor delivery device 115).

[0094] FIGs. 8A-8J provide a series of illustrations of deployment of hemostasis clip 600 via an assembly 800 of hemostasis clip 600, deployment device 700, a deployment ring 820, and endoscope / anchor delivery device 115. In particular, FIG. 8A provides a schematic, top view; FIG. 8B provides a schematic, side view; and FIG. 8C provides a schematic, perspective view of assembly 800 when hemostasis clip 600 is in an open state as may the case prior to deployment or use within a tubular organ.

[0095] As may be seen in FIG. 8A, hemostasis clip 600 includes a window, or opening, 810 formed when proximal and distal components 615 and 610 are extended away from one another (i.e., when hemostasis clip 600 is open). When hemostasis clip 600 is open, teeth 630 of opposing internal sides of distal and proximal components 610 and 615 are disengaged from one another and are positioned on opposing sides of window 810 as shown. FIG. 8A also shows extension 640 disengaged from array of ridges 645 as occurs with hemostasis clip 600 is open. Deployment ring 820 may be sized and positioned to fit between coupling 730 and proximal component 615 as shown in, for example, FIGs. 8A-8C. Deployment ring 820 may be configured to move along deployment device 700 to push proximal component 615 toward distal component 610, thereby reducing a size of window 810 and / or closing hemostasis clip 600 as seen in, for example, FIGs. 8G-8J.

[0096] In some embodiments, movement of deployment ring 820 may be facilitated and / or enabled by application of feree to a suture in communication with, endoscope / anchor delivery device 115, deployment ring 820, proximal component 615, and / or distal component202201. PT7W0610. For example, FIGs. 8D-8F provide illustrations of an assembly 800 with a first suture 850 and a second suture 855 configured and arranged to pull proximal component 615 toward distal component 610 disposed therein, wherein FIG. 8D provides a side view and FIG. 8F provides a front view of assembly 800 with first and second sutures 850 and 855 therein (shown in dashed lines to indicate that it may be positioned within components of assembly 800 as opposed to visible from the outside) and FIG. 8E provides a bottom view of deployment ring 820 (separated from assembly 800 and oriented as shown in FIG. 8F) with first and second sutures 850 and 855 thread therethrough. In some embodiments, FIG. First suture 850 may be disposed within assembly 800 so that an end of a first length of first suture 850a is attached to distal component 610, travels down (as oriented in FIG. 8D) and through a first aperture 825 of deployment ring 820. A second length of first suture 850b may traverse a portion of deployment ring and be thread through a second aperture 825b and exit deployment ring 820 as a third length of first suture 850c. Third length of suture 850c may extend toward distal component 610 to point (e.g., aperture, loop, etc.) and then extend downward (as oriented in FIG. 8F) toward deployment ring 820, through an aperture 827 in deployment ring 820, and into endoscope / anchor delivery device 115 as shown in FIG. 8F so that a surgeon or clinician may directly, or indirectly, access first suture 850. Second suture 855 may be thread through assembly 800 in a manner similar to (e.g., mirrors) the manner in which first suture 850 is thread through assembly 800 as shown.

[0097] To close hemostasis clip 600, a clinician may directly or indirectly exert a downward (as oriented in FIG. 8F) force (e.g., pull) on first and / or second sutures 850 and / or 855 to pull deployment ring 820 and proximal component 615 toward distal component 610 to reduce a size of window 810 and / or close hemostasis clip 600 as shown in FIGs. 8G-8I, wherein FIG. 8G is a side view, FIG. 8H is a top view, and FIG. 8I is a perspective view of assembly 800 with hemostasis clip 600 in a closed configuration.

[0098] FIGs. 9A-9C illustrate an exemplary method of using assembly 800 and / or hemostasis clip 600 to close an opening in a tubular organ. Initially, as shown in FIG. 9A, assembly 800 may be inserted into a tubular organ 900 proximate to, for example, an opening and / or incision 910 positioned between a first side of tubular organ 900a and a second side of tubular organ 900b. Tissue proximate to the opening and / or incision 900 (i.e., a portion of first and second sides of tubular organ 900a and 900b) may be invaginated into window 810 when hemostasis clip 600 is in an open configuration (as shown in FIG. 9A) and, once the tissue is properly positioned, hemostasis clip 600 may be translated into in a closed configuration and / or a configuration that reduces a size of window 810, thereby trapping the invaginated tissue within the closed (or smaller) window via tissue engagement mechanisms 630 as shown in FIG. 9B, which may act to close opening and / or incision 910 and / or cause hemostasis. Engagement between extension 640 and one or more ridges of202201. PT7W0array of ridges 645 may act to hold hemostasis clip 600 in a closed (or smaller) configuration, thereby trapping the invaginated tissue therein and / or causing hemostasis. Once hemostasis clip 600 is positioned within tubular organ 900, it may be released from deployment device 700 as shown in FIG. 8J, which is a view of assembly 800 with hemostasis clip 600 in a closed configuration and disengaged from endoscope / anchor delivery device 115 and FIG. 9C, which is an illustration of hemostasis clip 600 positioned within tubular organ 900 so that it holds first side of tubular organ 900a and second side of tubular organ 900b together, thereby closing opening and / or incision 910. In some embodiments, disengagement between hemostasis clip 600 and deployment device 700 may be performed by moving deployment ring 820 along deployment device 700, which acts to squeeze tabs 725 together so that they disengage from a corresponding feature (not shown) of proximal component 615, which acts to release proximal component 615 from deployment device 700 and remain in the tubular organ.

[0099] It is noted that the devices and methods disclosed in FIGs. 7A-9C are exemplary only and that other ways to deploy hemostasis clip 600 are contemplated by this disclosure. For example, a hemostasis clip 600 may be manually deployed, wherein a surgeon places hemostasis clip 600 into a tubular organ and / or portions of a tubular organ to close an opening and / or cause hemostasis and / or hemostasis clip 600 may be deployed and / or implanted into a tubular organ via deployment tool other than an endoscope (e.g., forceps and / or clamps).

[0100] In some embodiments, hemostasis clip 600 may be used to perform tissue approximation, assist with large defect closure as may occur when, for example, a portion of a tubular organ is removed via, for example, endoscopic mucosal resection to treat, for example, cancer or remove a polyp.

[0101] Accordingly, the plication anchor systems of the present disclosure provide methods for implanting plication anchor devices. Such methods include positioning the plication anchor system and / or an assembly of a plication anchor system and a stent, sleeve, or other gastric device within the tubular organ; applying negative pressure to the plication anchor system, thereby invaginating tissue of the tubular organ into a window of the plication anchor system; and actuating the plication anchor system to secure the tissue of the tubular organ within the window so that the plication anchor system and / or a device attached thereto is held in place.

[0102] The plicator anchor system, hemostasis clips, and / or components thereof may come in a variety of sizes depending on, for example, patient anatomy, patient size, patient age, patient co-morbidities, tubular organ type, and / or tubular organ diameter. Exemplary dimensions for an outer diameter of plicator anchor system 110 and / or components thereof202201. PT7W0may be within a range of, for example, 8mm to 30 mm and exemplary lengths of plicator anchor system may be within a range of, for example, 8mm-40mm.

[0103] The plicator anchor systems, hemostasis clips, and / or components thereof may be made from any suitable material, including, but not limited to, a metal (e.g., stainless steel), a nickel-titanium alloy (nitinol), plastic, and / or a biodegradable / bioabsorbable (to allow natural removal of a placed PAD from a tubular organ) or non-biodegradable polymer.

[0104] Exemplary biodegradable / bioabsorbable polymers and / or materials that may be used with the systems and / or devices disclosed herein include without limitation, polyarylates (L-tyrosine- derived or free acid), poly(a-hydroxy-esters), poly(a-hydroxy-esters), polyamides, poly(amino acid), polyalkanotes, polyalkylene alkylates, polyalkylene oxylates, polyalkylene succinates, polyanhydrides, polyanhydride esters, polyaspartimic acid, polybutylene diglycolate, poly(caprolactone), poly(caprolactone) / poly(ethylene glycol) copolymers, poly(carbonate), L- tyrosine-derived polycarbonates, polycyanoacrylates, polydihidropyrans, poly(dioxanone), poly-p- dioxanone, poly(epsilon-caprolactone), poly(epsilon-caprolactone-dimethyltrimethylene carbonate), poly(esteramide), poly(esters), aliphatic polyesters, poly(etherester), polyethylene glycol) / poly( orthoester) copolymers, poly(glutarunic acid), poly(glycolic acid), poly(glycolide), poly(glycolide) / poly(ethylene glycol) copolymers, poly(glycolide-trimethylene carbonate), poly(hydroxyalkanoates), poly(hydroxybutyrate), poly(hydroxybutyrate-co-valerate), poly(imino carbonates), polyketals, poly(lactic acid), poly(lactic acid-co-glycolic acid), poly(lactic acid-co-glycolic acid) / poly(ethylene glycol) copolymers, poly(lactide), poly(lactide-co-caprolactone), poly(DL-lactide-co-glycolide), poly(lactide-co-glycolide) / poly(ethylene glycol) copolymers, poly(lactide) / poly(ethylene glycol) copolymers, poly(lactide) / poly(glycolide) copolymers, polyorthoesters, poly(oxyethylene) / poly(oxypropylene) copolymers, polypeptides, polyphosphazenes, polyphosphoesters, polyphosphoester urethanes, polypropylene fumarate-coethylene glycol), poly(trimethylene carbonate), polytyrosine carbonate, polyurethane, PorLastin or silk-ealastin polymers, spider silk, tephaflex, terpolymer (copolymers of glycolide, lactide or dimethyltrimethylene carbonate), and combinations, mixtures or copolymers thereof. In one variation, the biodegradable polymer is polycaprolactone (PCL).

[0105] Examples of non-biodegradable polymers that may be used with the systems and / or devices disclosed herein include, but are not limited to, poly(ethylene vinyl acetate), poly(vinyl acetate), silicone polymers, polyurethanes, polysaccharides such as a cellulosic polymers and cellulose derivatives, acyl substituted cellulose acetates and derivatives thereof, copolymers of poly(ethylene glycol) and poly(butylene terephthalate), polystyrenes,202201. PT7W0polyvinyl chloride, polyvinyl fluoride, poly(vinyl imidazole), chorosulphonated polyolefins, polyethylene oxide, and copolymers and blends thereof.

[0106] The terminology used in this disclosure is intended solely to describe specific embodiments and should not be interpreted as limiting the scope of the disclosure. For instance, unless clearly stated otherwise, singular terms such as “a,” “an,” and “the” should be understood to include their plural counterparts. Additionally, terms like “contains,” “containing,” “includes,” “including,” “comprises,” “comprising,” and similar expressions indicate the presence of certain features, numbers, steps, operations, elements, or components, but do not exclude the possibility of additional or alternative features, steps, or components.

[0107] Directional or orientation terms used herein are provided only for reference and should not be seen as limiting. However, it is acknowledged that such terms may relate to the position of a user or operator. Therefore, no restrictions should be inferred from their usage. Furthermore, ordinal terms such as “first,” “second,” or “third” are used solely to distinguish elements and do not imply any sequence or required quantity. For example, referencing a “third” component does not necessitate the existence of a “first” or “second.” Additionally, the terms “coupled,” “connected,” or “attached,” whether used with or without “to,” may refer to either direct or indirect connections unless explicitly stated otherwise.

[0108] Although several exemplary embodiments have been described, those skilled in the art will recognize that substitutions, changes, and modifications can be made without departing from the scope and spirit of the disclosure. The described embodiments are not intended to be limiting or to represent the only way to implement the disclosure. Rather, the disclosure is meant to encompass all alternatives and equivalents that fall within the scope of the appended claims. Furthermore, when the claims refer to an apparatus, system, or component as being “adapted to,” “configured to,” “enabled to,” or similar phrases with regard to performing a function, such language covers the ability of that element to perform the function — even if the function is not currently active, in use, or enabled.

Claims

202201. PT7W0CLAIMS:What is claimed is:

1. A plication anchor system configured for implantation within a tubular organ, the system comprising:a plication anchor device comprising:an outer component including a first lumen, a plurality of needles, and a retention mechanism; andan inner component including a second lumen and a plurality of projections extending from an outer surface of the inner component, each of the plurality of projections being arranged and configured to engage with the retention mechanism,wherein a portion of the inner component is disposed within the outer component so that the first lumen aligns with the second lumen, thereby generating a central lumen for the plicator anchor device,wherein the inner component disposed within the outer component forms a window with an open area to into which a portion of a tubular organ tissue may be invaginated when the plication anchor device is implanted into the tubular organ and the plication anchor device is in an open configuration,wherein the plication anchor device is configured to translate from the open configuration to a closed configuration as the inner component is pushed toward outer component, thereby pushing the plurality of needles into the window and piercing the invaginated tissue of the tubular organ therein with the needles so that the plication anchor device is securely implanted within the tubular organ; andan adaptor configured for mechanical attachment to the plication anchor device and a plication anchor delivery device.

2. The system of claim 1 , wherein the outer component further comprises a plurality of barbs configured to attach a stent to the plication anchor device.

3. The system of claim 1 or 2, wherein the adaptor is removably attached to at least one of the plication anchor delivery device and the plication anchor device.

4. The system of any of the above claims, further comprising a stent coupled to the outer component and configured for delivery and implantation in the tubular organ.

5. The system of claim 2, further comprising a stent coupled to the outer component using the plurality of barbs and configured for delivery and implantation in the tubular organ.202201. PT7W06. The system of any of the above claims, wherein the system or a component thereof has an outer diameter of 8 mm to 30 mm.

7. The system of any of the above claims, wherein the system or a component thereof has a length of 8 mm to 40 mm.

8. The system of any of the above claims, wherein the system or a component thereof is composed of a metal, a nickel-titanium alloy, plastic, a biodegradable / bioabsorbable, ora non-biodegradable polymer.

9. The system of any of the above claims, further comprising:a suture in communication with at least one of the inner component and the outer component, wherein application offeree to the suture pulls the outer component toward the inner component thereby reducing the size of the open area of the window and clamping the invaginated tubular organ tissue therein with the needles so that the plication anchor device is securely implanted within the tubular organ.

10. The system of any of the above claims, wherein the plication anchor delivery device is an endoscope.

11. A plication anchor device comprising:an outer component including a first lumen, a plurality of needles, and a retention mechanism; andan inner component including a second lumen and a plurality of projections extending from an outer surface of the inner component, each of the plurality of projections being arranged and configured to engage with the retention mechanism,wherein a portion of the inner component is disposed within the outer component so that the first lumen aligns with the second lumen, thereby generating a central lumen for the plicator anchor device,wherein the inner component disposed within the outer component forms a window with an open area to into which a portion of tissue of the tubular organ may be invaginated when the plication anchor device is implanted into the tubular organ and the plication anchor device is in an open configuration,wherein the plication anchor device is configured to translate from the open configuration to a closed configuration as the inner component is pushed toward outer component, thereby pushing the plurality of needles into the window and piercing the invaginated tubular organ tissue therein with the needles so that the plication anchor device is securely implanted within the tubular organ.202201. PT7W012. The device of claim 11, wherein the outer component further comprises a plurality of barbs.

13. The device of claim 12, wherein the plurality of barbs are configured to attach a stent to the device.

14. The device of claim 11, 12, or 13, further comprising a stent coupled to the outer component and configured for delivery and implantation in the tubular organ.

15. The device of any of claims 11-14, further comprising an adaptor configured for mechanical attachment to the device and a plication anchor delivery device.

16. The device of claim 15, wherein the plication anchor delivery device is an endoscope.

17. The device of any of claims 9 to 13, wherein the device or a component thereof has an outer diameter of 8 mm to 30 mm.

18. The device of any of claims 9 to 14, wherein the device or a component thereof has a length of 8 mm to 40 mm.

19. The device any of claims 9 to 15, wherein the device or a component thereof comprises a metal, a nickel-titanium alloy, plastic, a biodegradable material, a bioabsorbable material, and / or a non-biodegradable polymer.

20. The device of any of claims 11-18, further comprising:a suture in communication with at least one of the inner component and the outer component, wherein application offeree to the suture pulls the outer component toward the inner component thereby pushing the plurality of needles into the window.

21. A method for implanting a plication anchor system into a tubular organ of a patient, the method comprising:positioning the plication anchor system within the tubular organ;applying negative pressure to the plication anchor system, thereby invaginating tissue of the tubular organ into a window of the plication anchor system; andactuating the plication anchor system to secure the tissue of the tubular organ within the window.202201. PT7W022. The method of claim 21 , wherein the plication anchor system comprises a plication anchor device, the device comprising:an outer component including a first lumen, a plurality of needles, and a retention mechanism; andan inner component including a second lumen and a plurality of projections extending from an outer surface of the inner component, each of the plurality of projections being arranged and configured to engage with the retention mechanism,wherein a portion of the inner component is disposed within the outer component so that the first lumen aligns with the second lumen, thereby generating a central lumen for the plicator anchor device,wherein the inner component disposed within the outer component forms the window with an open area to into which a portion of the tissue of the tubular organ is invaginated when the plication anchor device is implanted into the tubular organ and the plication anchor device is in an open configuration,wherein the plication anchor device is configured to translate from the open configuration to a closed configuration as the inner component is pushed toward outer component, thereby pushing the plurality of needles into the window and piercing the invaginated tubular organ tissue therein with the needles so that the plication anchor device is securely implanted within the tubular organ.

23. The method of claim 22, wherein the outer component further comprises a plurality of barbs configured to couple a stent to the plication anchor device.

24. The method of any of claims 21 to 22, further comprising implanting a stent into the tubular organ, the stent being coupled to the outer component.

25. The method of claim 24, further comprising treating or protecting the tissue of the tubular organ via implanting the stent.

26. The method of any of claim 21 to 25 further comprising:applying force to a suture in communication with at least one of the inner component and the outer component, wherein application of the force pulls the outer component toward the inner component thereby pushing the plurality of needles into the window and clamping the invaginated tubular organ tissue therein with the needles so that the plication anchor device is securely implanted within the tubular organ.202201. PT7W027. A method for implanting an assembly of a stent into a tubular organ of a patient, the method comprising:positioning an assembly of the stent and a plication anchor system within the tubular organ;applying negative pressure to the plication anchor system, thereby invaginating tissue of the tubular organ into a window of the plication anchor system; andactuating the plication anchor system to secure the tissue of the tubular organ within the window and the stent within the tubular organ.

28. The method of claim 28, wherein the plication anchor system comprises a plication anchor device, the device comprising:an outer component including a first lumen, a plurality of needles, and a retention mechanism; andan inner component including a second lumen and a plurality of projections extending from an outer surface of the inner component, each of the plurality of projections being arranged and configured to engage with the retention mechanism,wherein a portion of the inner component is disposed within the outer component so that the first lumen aligns with the second lumen, thereby generating a central lumen for the plicator anchor device,wherein the inner component disposed within the outer component forms the window with an open area to into which a portion of the tissue of the tubular organ is invaginated when the plication anchor device is implanted into the tubular organ and the plication anchor device is in an open configuration,wherein the plication anchor device is configured to translate from the open configuration to a closed configuration as the inner component is pushed toward outer component, thereby pushing the plurality of needles into the window and piercing the invaginated tubular organ tissue therein with the needles so that the plication anchor device is securely implanted within the tubular organ.

29. The method of claim 28, wherein the outer component further comprises a plurality of barbs configured to couple the stent to the plication anchor system.

30. The method of claim 24, further comprising treating or protecting the tissue of the tubular organ via positioning the assembly of the stent and the plication anchor system within the tubular organ.

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