Devices and methods for creating or augmenting gastric flap valves

Abstract

A method of deploying a prosthetic flap valve system within a patient includes positioning the prosthetic flap valve system on an endoscope or laparoscope, advancing the endoscope or laparoscope with the prosthetic flap valve system to an anchoring site at the gastroesophageal junction (GEJ) of the patient, anchoring the prosthetic flap valve system to tissue of the patient at the anchoring site, and deploying the prosthetic flap valve system.

Description

[0001] Atorney Docket No. 07039-2362WO1 / 2023-018

[0002] DEVICES AND METHODS FOR CREATING OR AUGMENTING GASTRIC FLAP VALVES

[0003] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority' to U.S. Application Serial No. 63 / 791,002, filed on April 18, 2025. The disclosure of the prior application is considered part of the disclosure of this application, and is incorporated in its entirety into this application.

[0004] TECHNICAL FIELD

[0005] This document relates to devices and methods for creating or augmenting a gastric flap valve to manage gastroesophageal disorders. For example, this document relates to devices and methods for creating a prosthetic gastric flap valve or augmenting an existing gastric flap valve to manage gastroesophageal reflux disease (GERD) and / or hiatal hernia. This document also relates to devices and methods for delivering a prosthetic gastric flap valve to manage GERD and / or hiatal hernia.

[0006] BACKGROUND INFORMATION

[0007] Gastric backflow associated with conditions like GERD and / or hiatal hernia, cause chronic discomfort and health complications. Gastric backflow (e.g.. gastric acid or bile back up) occurs as a consequence of lower esophageal junction dysfunction or relaxation, allowing gastric contents to move into the esophagus. During swallowing, the lower esophageal junction should transiently relax and its flap valve transiently open by¬ shortening to an open position away from the lesser curvature of the stomach to permit food passage but should promptly contract and flap valve elongates and closed toward the lesser curvature of the stomach to prevent reflux. With GERD, this anti-reflux barrier and mechanism is inadequate, enabling acid to flow back into the esophagus. Similarly, a hiatal hernia may lead to an altered angle between the esophagus and stomach with effacement, shortening, or disappearance of the flap-value structure or function creating a niche for acid, bile, or combination (bile and acid) regurgitation.

[0008] The Hill classification stratifies GERD severity' based on anatomical and functional perturbations. Grade I reflects normal lower esophageal junction anatomy and function. Grade II indicates partial lower esophageal junction disruption. Grade III signifies significant lower esophageal junction impairment and gastroesophageal junctionAtorney Docket No. 07039-2362WO1 / 2023-018 distortion. Grade IV denotes severe anatomical and functional aberrations, including substantial esophageal displacement above the diaphragm. These gradations aid clinicians in tailoring management strategies and interventions, considering the extent of disruption and potential complications.

[0009] SUMMARY

[0010] This document describes devices and methods for creating or augmenting a gastric flap valve to manage gastroesophageal disorders in a subject (e.g., a human or animal) with native or surgically altered anatomy. This document also describes devices and methods for delivering a prosthetic gastric flap valve to manage gastroesophageal disorders in a subject. Examples of surgically altered anatomy include, post bariatric and metabolic surgery or myotomies of the gastroesophageal junction (GEJ), such as heller myotomy or per-oral endoscopic myotomy (POEM) that alters the anti-reflux barrier of the GEJ.

[0011] Disclosed herein are implantable elongation members and implantable anchor members that can be configured to assist in the elongation of a native (e.g., non-prosthetic) flap valve such that it remains in a closed position while still allowing normal swallowing, eating, and drinking. Also disclosed herein are prosthetic flap valves that can be implanted with or without elongation members. The improved prosthetic flap valves can be configured to replace native flap valve operation that does not function due to gastroesophageal disorders (e.g., GERD or hiatal hernia). The improved elongation devices and / or prosthetic flap valves disclosed herein can mitigate gastric back flow as a treatment for gastroesophageal disorders in multiple clinical situation; such as primary pathological reflux with non-surgical altered anatomy or pathologic reflux as results of surgical alteration of the anti-reflux barrier as seen after some bariatric and metabolic surgeries; such as laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass. Or, after myotomies of the GEJ, such as heller myotomy or POEM that alters the anti-reflux barrier of the GEJ. Also disclosed herein are delivery systems and methods to deliver the above-noted implantable members and flap valves.

[0012] The improved devices and methods for creating or augmenting gastric flap valves described in this document aim to address a significant problem that remains unmet by¬ current technology. Presently, there are no viable methods to elongate, augment, or replace a gastric flap valve to prevent gastric back flow and provide treatment and reliefAtorney Docket No. 07039-2362WO1 / 2023-018 to a subject suffering from GERD and / or hiatal hernia without surgical intervention; (e.g., in the context of foregut surgery, such as bariatric surgery). This pressing issue underscores the need for a solution that can accurately and less-invasively improve the function of gastric flap valves in the context of pathologic reflux both in native and or surgically altered anatomy of the stomach.

[0013] Some embodiments of the devices and methods described herein may provide one or more of the following advantages. First, embodiments described herein disclose minimally invasive treatments for less severe cases of GERD with or without hiatal hernia. For example, devices herein include elongation members that can are configured to couple to native tissue and improve gastric flap valve function. Such elongation members can be positioned utilizing endoscopic, laparoscopic, or hybrid techniques. This allows for precise placement of prosthetic elongation members and anchor members with reduced tissue trauma, minimizing postoperative discomfort and expediting patient recovery.

[0014] Second, embodiments described herein disclose prosthesis or partial prosthesis for gastric flap valves that are customized to the subject based on the severity of the disease. For example, tailoring the prosthesis to individual patient anatomy enables a personalized solution, optimizing its effectiveness in preventing gastric back up while accommodating variations in hiatal hernia (transverse or axial lengths) and GERD presentation.

[0015] Third, embodiments described herein disclose prosthesis or partial prosthesis for gastric flap valves that can mitigate reflux without compromising normal gastroesophageal functions, maintaining physiological processes such as swallowing and belching. Further, endoscopic, laparoscopic approaches, and hybrid methods combining both, offer the potential for prosthesis adjustment or removal, allowing for modifications as needed to achieve optimal outcomes.

[0016] Fourth, embodiments described herein disclose prosthesis or partial prosthesis for gastric flap valves can improve quality of life and decrease the dependence on medication. For example, successful placement of the prosthesis may decrease or eliminate the need for long-term medication usage to manage GERD symptoms, potentially enhancing patient quality of life and mitigating medication-related side effects.Atorney Docket No. 07039-2362WO1 / 2023-018 Fifth, devices and techniques described herein, can be uniquely utilized to manage iatrogenic GERD resulting from foregut surgery, such as bariatric and metabolic surgery, achalasia surgery, and cancer surgery.

[0017] In an aspect, a method of deploying a prosthetic flap valve system within a patient includes positioning the prosthetic flap valve system on an endoscope or laparoscope, advancing the endoscope or laparoscope with the prosthetic flap valve system to an anchoring site at the gastroesophageal junction (GEJ) of the patient, anchoring the prosthetic flap valve system to tissue of the patient at the anchoring site, and deploying the prosthetic flap valve system.

[0018] In some embodiments, positioning the prosthetic flap valve system on the endoscope or laparoscope includes wrapping the prosthetic flap valve system around a distal end of the endoscope or laparoscope.

[0019] In some embodiments, anchoring the prosthetic flap valve system at the anchoring site includes anchoring one or more of a magnet, a helical structure fastener, a clip structure, a tissue anchor, a needle pin, an anchoring ring, a screw, a suture, a plication basket, or a staple at the anchoring site.

[0020] In some embodiments, anchoring the prosthetic valve includes anchoring a clip structure, including retracting a portion of the clip structure to cause an engagement surface to engage the tissue of the patient.

[0021] In some embodiments, anchoring the clip structure includes rotating a lock shaft of the clip structure to lock the portion of the clip structure.

[0022] In some embodiments, anchoring the clip structure includes crimping the engagement surface of the clip structure.

[0023] In some embodiments, anchoring the prosthetic flap valve system at the anchoring site includes anchoring a clip at the anchoring site.

[0024] In some embodiments, anchoring the clip includes retracting a portion of the clip to cause an engagement surface to engage the tissue of the patient.

[0025] In some embodiments, anchoring the clip further includes rotating a lock shaft of the clip to lock the portion of the clip.

[0026] In some embodiments, anchoring the clip includes crimping the engagement surface of the clip.

[0027] In some embodiments, deploying the prosthetic valve flap system includes allowing the prosthetic valve flap system to open.Atorney Docket No. 07039-2362WO1 / 2023-018 In some embodiments, deploying the prosthetic valve flap system includes removing a restraining band from the prosthetic valve flap system.

[0028] In some embodiments, deploying the prosthetic valve flap system includes moving a release wire axially to remove the restraining band from the prosthetic valve flap system.

[0029] In some embodiments, the prosthetic flap valve system includes an elongation member having a first end and a second end, a first anchor member coupled to the first end of the elongation member and configured to couple the first end of the elongation member to the gastric wall of the GEJ of the patient, a second anchor member coupled to the second end of the elongation member and configured to couple the second end of the elongation member to a flap valve, wherein the elongation member is configured to bias the flap valve to a closed position, and wherein the closed position of the flap valve provides a separation between the esophagus and the stomach.

[0030] In some embodiments, the elongation member is one of a compression spring, an extension spring, a torsion spring, or an elastic band.

[0031] In some embodiments, the first and second anchor members are one or more of a magnet, a helical structure fastener, a clip structure, a tissue anchor, a needle pin, an anchoring ring, a screw, a suture, a plication basket, or a staple.

[0032] In some embodiments, the flap valve is anon-prosthetic flap valve.

[0033] In some embodiments, the first anchor member is configured to couple the first end of the elongation member to the gastric wall portion is toward the lesser curvature of the stomach such that the elongation member is contracted when the flap valve is biased in an open position.

[0034] In some embodiments, the first anchor member is configured to couple the first end of the elongation member to the gastric wall portion is toward the greater curvature of the stomach such that the elongation member is compressed when the flap valve is biased in an open position.

[0035] In some embodiments, the prosthetic flap valve system includes a prosthetic flap valve having a first end, a second end, and a border that demarcates an interface between the prosthetic flap valve and tissue of a subject, a gasket coupled to the border and the interface between the prosthetic flap valve and tissue of a subject, one or more anchor members coupled to the first end of the prosthetic flap valve and configured to anchor the prosthetic flap to tissue of the subject, a second end of the prosthetic flap valve oppositeAtorney Docket No. 07039-2362WO1 / 2023-018 the first end, wherein the second end of the prosthetic flap valve is configured to bias to a closed position toward the lesser curvature of the stomach, and wherein the closed position of the prosthetic flap valve provides a separation between the esophagus and the stomach of the subject.

[0036] In some embodiments, the gasket is configured to interface the prosthetic flap valve to tissue of the subject when biased in the closed position.

[0037] In some embodiments, the gasket is made from a silicone material.

[0038] In some embodiments, the one or more anchor members are one or more of a magnet, a helical structure fastener, a clip structure, a tissue anchor, a needle pin. a screw, a suture, a plication basket, or a staple.

[0039] In some embodiments, the prosthetic flap valve system includes one or more magnets coupled to the second end of the prosthetic valve, wherein the one or more magnets are configured to secure the second side of the prosthetic flap valve to the tissue of the subject when the prosthetic flap valve is biased in the closed position.

[0040] In another aspect, a method of implanting a prosthetic flap valve system within a patient includes identifying a subject as having GERD and / or a hiatal hernia, determining a treatment based on a severity of the GERD, the presence or absence of a native flap valve, and / or hiatal hernia, selecting the prosthetic flap valve system based on the determined treatment, positioning the prosthetic flap valve system on an endoscope or laparoscope, advancing the endoscope or laparoscope with the prosthetic flap valve system to an anchoring site at the gastroesophageal junction (GEJ) of the patient, anchoring the prosthetic flap valve system to tissue of the patient at the anchoring site, and deploying the prosthetic flap valve system.

[0041] In some embodiments, positioning the prosthetic flap valve system on the endoscope or laparoscope includes wrapping the prosthetic flap valve system around a distal end of the endoscope or laparoscope.

[0042] In some embodiments, anchoring the prosthetic flap valve system at the anchoring site includes anchoring a clip at the anchoring site.

[0043] In some embodiments, anchoring the clip includes retracting a portion of the clip to cause an engagement surface to engage the tissue of the patient.

[0044] In some embodiments, anchoring the clip further includes rotating a lock shaft of the clip to lock the portion of the clip.Atorney Docket No. 07039-2362WO1 / 2023-018 In some embodiments, anchoring the clip includes crimping the engagement surface of the clip.

[0045] In some embodiments, deploying the prosthetic valve flap system includes allowing the prosthetic valve flap system to open.

[0046] In some embodiments, deploying the prosthetic valve flap system includes removing a restraining band from the prosthetic valve flap system.

[0047] In some embodiments, deploying the prosthetic valve flap system includes moving a release wire axially to remove the restraining band from the prosthetic valve flap system.

[0048] In some embodiments, the prosthetic flap valve system includes an elongation member having a first end and a second end, a first anchor member coupled to the first end of the elongation member and configured to couple the first end of the elongation member to the gastric wall of the GEJ of the patient, a second anchor member coupled to the second end of the elongation member and configured to couple the second end of the elongation member to a flap valve, wherein the elongation member is configured to bias the flap valve to a closed position, and wherein the closed position of the flap valve provides a separation between the esophagus and the stomach.

[0049] In some embodiments, the elongation member is one of a compression spring, an extension spring, a torsion spring, or an elastic band.

[0050] In some embodiments, the first and second anchor members are one or more of a magnet, a helical structure fastener, a clip structure, a tissue anchor, a needle pin, an anchoring ring, a screw, a suture, a plication basket, or a staple.

[0051] In some embodiments, the flap valve is anon-prosthetic flap valve.

[0052] In some embodiments, the first anchor member is configured to couple the first end of the elongation member to the gastric wall portion is toward the lesser curvature of the stomach such that the elongation member is contracted when the flap valve is biased in an open position.

[0053] In some embodiments, the first anchor member is configured to couple the first end of the elongation member to the gastric wall portion is toward the greater curvature of the stomach such that the elongation member is compressed when the flap valve is biased in an open position.

[0054] In some embodiments, the prosthetic flap valve system includes a prosthetic flap valve having a first end, a second end, and a border that demarcates an interface betweenAtorney Docket No. 07039-2362WO1 / 2023-018 the prosthetic flap valve and tissue of a subject, a gasket coupled to the border and the interface between the prosthetic flap valve and tissue of a subject, one or more anchor members coupled to the first end of the prosthetic flap valve and configured to anchor the prosthetic flap to tissue of the subject, a second end of the prosthetic flap valve opposite the first end, wherein the second end of the prosthetic flap valve is configured to bias to a closed position toward the lesser curvature of the stomach, and wherein the closed position of the prosthetic flap valve provides a separation between the esophagus and the stomach of the subject.

[0055] In some embodiments, the gasket is configured to interface the prosthetic flap valve to tissue of the subject when biased in the closed position.

[0056] In some embodiments, the gasket is made from a silicone material.

[0057] In some embodiments, the one or more anchor members are one or more of a magnet, a helical structure fastener, a clip structure, a tissue anchor, a needle pin. a screw, a suture, a plication basket, or a staple.

[0058] In some embodiments, the prosthetic flap valve system includes one or more magnets coupled to the second end of the prosthetic valve, wherein the one or more magnets are configured to secure the second side of the prosthetic flap valve to the tissue of the subject when the prosthetic flap valve is biased in the closed position.

[0059] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Although methods and materials similar or equivalent to those described herein can be used to practice the invention, suitable methods and materials are described below. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

[0060] The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.Atorney Docket No. 07039-2362WO1 / 2023-018 DESCRIPTION OF THE DRAWINGS FIG. 1 depicts a cross-section schematic of an esophageal and stomach system, gastric flap valve, and endoscope.

[0061] FIG. 2 depicts a schematic of various layers of the esophageal and stomach system of FIG. I.

[0062] FIG. 3 depicts a cross-section schematic of an endoscope inside a stomach and lower esophageal junction with a gastric flap valve in a closed position.

[0063] FIG. 4 depicts a cross-section schematic of the endoscope inside the stomach and lower esophageal junction of FIG. 3 with the gastric flap valve in an open position after a swallow or because of the effacement of flap-valve, such as in the setting of a hiatal hernia.

[0064] FIG. 5 depicts an endoscopic ultrasound image of a stomach and gastroesophageal junction of a subject.

[0065] FIG. 6 depicts a cross-section view of an example elongation member inside the stomach and lower gastroesophageal junction.

[0066] FIG. 7 depicts a perspective view of the example elongation member of FIG. 6 inside the stomach and gastroesophageal junction.

[0067] FIG. 8 depicts a cross-section view of another example elongation member inside the stomach and gastroesophageal junction.

[0068] FIG. 9 depicts a perspective view of the example elongation member of FIG. 8 inside the stomach and gastroesophageal junction.

[0069] FIG. 10 depicts a cross-section view of an example prosthetic flap valve system inside a stomach and gastroesophageal junction.

[0070] FIG. 11 depicts a perspective view of the example prosthetic flap valve system of FIG. 10 inside a stomach and gastroesophageal junction.

[0071] FIG. 12 depicts a cross-section view of another example prosthetic flap valve system inside a stomach and gastroesophageal junction.

[0072] FIG. 13 depicts a perspective view of the example prosthetic flap valve of FIG. 12 inside a stomach and gastroesophageal junction.

[0073] FIG. 14 depicts a cross-section schematic of an endoscopic ultrasound delivering a flap-valve augmentation prosthetic elements to the gastroesophageal junction.

[0074] FIG. 15 depicts an example prosthetic flap valve system installed on an endoscope for an endoscopic delivery into the gastroesophageal junction.Atorney Docket No. 07039-2362WO1 / 2023-018 FIG. 16 depicts an example prosthetic flap valve system with a clip for attaching to the gastroesophageal junction.

[0075] FIG. 17 depicts an example endoscope for delivering flap-valve augmentation prosthetic elements to the gastroesophageal junction.

[0076] FIG. 18 depicts an example clip for attaching a prosthetic flap valve system to the gastroesophageal junction.

[0077] FIG. 19 depicts the example clip of FIG. 18 attaching to the tissue of the gastroesophageal junction.

[0078] FIG. 20 depicts an example clip for attaching a prosthetic flap valve system to the gastroesophageal junction.

[0079] FIG. 21 depicts the example clip of FIG. 20 attaching to the tissue of the gastroesophageal junction.

[0080] FIG. 22 depicts an example clip with wires configured to be attached to a prosthetic flap valve to form a prosthetic flap valve system.

[0081] FIG. 23 depicts the example clip with wires of FIG. 22 and a prosthetic flap valve. FIG. 24 depicts the example clip with wires of FIG 22 attached to the prosthetic flap valve of FIG. 23 to form a prosthetic flap valve system.

[0082] FIG. 25 depicts the example prosthetic flap valve system of FIG. 24 installed on the endoscope of FIG. 17 for an endoscopic delivery into the gastroesophageal junction.

[0083] FIG. 26 depicts a side view' of an example prosthetic flap valve system.

[0084] FIG. 27 depicts a side view' of another example prosthetic flap valve system. FIG. 28 depicts an example prosthetic flap valve system inside a stomach and gastroesophageal junction.

[0085] FIG. 29 depicts the example prosthetic flap valve system of FIG. 28 inside an esophagus and the gastroesophageal junction.

[0086] FIG. 30 depicts a side view of an example prosthetic flap valve system.

[0087] FIG. 31 depicts a side view of another example prosthetic flap valve system. FIG. 32 depicts atop view of an example prosthetic flap valve system.

[0088] FIG. 33 depicts a top view of another example prosthetic flap valve system overlayed with the example prosthetic flap valve system of FIG. 32.

[0089] FIG. 34 depicts an example method for implanting a prosthetic flap valve system into a subject.Atorney Docket No. 07039-2362WO1 / 2023-018 FIG. 35 depicts an example of a robotic system that can be used to deliver a prosthetic flap valve system.

[0090] DETAILED DESCRIPTION FIG. 1 depicts a cross-section schematic of an esophageal and stomach system 100, flap valve 114 (e g., a gastric flap valve), and an endoscope 102. The motion of flap valve 114 is depicted by arrow 106, illustrating the mechanics of the movement of the flap valve 114 to an open position and a closed position. The improved devices and methods disclosed herein are best comprehended through a description of how flap valve 114 operates in accommodating oral intake. As such, FIG. 1 describes the anatomy of the esophageal and stomach system 100 such that the movement of the flap valve 114 indicated by the arrow 106 can be understood.

[0091] The flap valve 114 opens to accommodate oral intake by upward translocation and then closes by elongation and apposition toward the lesser curvature 134 of the stomach 109. The angle of His 104 is the angle formed at the junction of the esophagus 120 (occupied by the endoscope 102) and stomach 109, contributing to the movement and the structure of the flap valve 114. The cardia 108 is the area of the stomach distal to the esophagus 120 and proximal to the distal stomach 109, which is transition zone. The lesser curvature 134 is the inward, concave curve of the stomach 109 connecting the cardia 108 and the pylorus 110, shaping the stomach’s structure. The pylorus 110 is a muscular structure regulating food passage from the stomach 109 to the small intestine. The incisura angularis 112 is a concave notch on the lesser curvature 134 influencing the efficiency of the flap valve 114. The crus 118 is a muscular support encasing the esophagus 120 as it passes through the diaphragm, reinforcing circular esophageal muscles of the esophagus 120. The phrenoesophageal ligament 116 is connective tissue linking the esophagus 120 to the diaphragm, stabilizing the circular esophageal muscles of the esophagus 120.

[0092] The flap valve 114 is a complex composed of the angle of His 104, esophageal muscularis propria overlapping the cardia 108 / fundus muscularis propria with a lip (bulking the valve structure) made of connective tissue and lymphoid aggregates (described in greater detail in connection with FIG. 5), acting as a barrier to stomach acid.

[0093] FIG. 2 depicts a schematic of various layers of the esophageal and stomach system of FIG. 1. The system 200 depicted in FIG. 2 includes the longitudinal sling fibers 236Atorney Docket No. 07039-2362WO1 / 2023-018 which are longitudinal muscle fibers covering the angle of His 104 of FIG. 1, fundus 230, and greater curvature 232, aiding esophagus 220 closure and junction angle. The fundus 230 is an upper, expandable portion of the stomach 209 above the gastroesophageal junction, aiding in food storage and regulation. Accommodation of the fundus 230 in response to food also augments the closure of the flap valve (e.g.. 114 of FIG. 1) and alters the angle of His. The greater curvature 232 is the outward, convex curve of the stomach 209, involved in food storage and mixing. The clasp fibers 238 are short fibers along the superior edge of the lesser curvature 134 of FIG. 1, supporting stomach structure and contractions. The mucosa 240 is the inner lining of stomach 209 and esophagus 220, providing protective barrier against stomach acid and enzymes.

[0094] An example of normal (e.g., non-GERD or hiatal hernia affected) process of oral intake is described with reference to the structures discussed in FIGS. 1 and 2. During the process of normal oral intake (e.g., swallowing or eating), orchestrated by a sequence of coordinated muscular actions and anatomical interactions, the construct that is the flap valve 114 mechanism undergoes movements to facilitate opening and subsequent closure of the junction between the stomach 109 and the esophagus 120, ensuring efficient passage of ingested material while preventing reflux. As swallowing (e.g., swallowing food) is initiated, the upper esophagus relaxes, allowing the food to enter the esophagus 120. The longitudinal sling fibers 236 enveloping the angle of His 104, fundus 230, and greater curvature 232 contribute to the initial phase of food propulsion downward toward the stomach 109 / 209. Approximately simultaneously, the circular esophageal muscles of the esophagus 120 contract, generating peristaltic waves that propel the food along the esophagus 120. Upon reaching the junction of the esophagus 120 and the stomach 109 (e.g., the gastroesophageal junction (GEJ)), the incisura angularis 112 influences the angle and effectiveness of the flap valve 114.

[0095] As the food approaches the GEJ, the circular esophageal muscle of the esophagus 120 contract, exerting pressure on the angle of His 104 and the fundus 230. To accommodate oral intake, the flap valve 114 opens through an upward translocation moving toward the fundus 203 and the angle of His 104. The coordinated actions of the circular esophageal muscle of the esophagus 120, longitudinal sling fibers 236, fundus 230, and greater curvature 232 allow the flap valve 114 to open by way of structure shortening (resulting in the upward translocation), permitting the food to enter the stomach 109. Subsequently, to close the flap valve 114, elongation of the muscles occursAtorney Docket No. 07039-2362WO1 / 2023-018 toward the lesser curvature 134 of the stomach 109 as illustrated by arrow 106. The circular esophageal muscle of the esophagus 120, along with the longitudinal sling fibers 236, contract and tighten, while the connective tissue and lymphoid aggregate lip contribute to the flap valve 114 closure.

[0096] The interplay of the flap valve 114 mechanism in the context of GERD and hiatal hernia introduces distinct alterations to the normal anti-reflux barrier, influencing the opening and closing dynamics. For example, in GERD, the compromised function of the flap valve 114 mechanism can result in inadequate closure or effacement of the flap valve 114. The angle of Elis 104. which typically aids in preventing reflux, may experience reduced efficacy due to weakened muscular support and altered anatomical alignment. This can lead to incomplete closure of the flap valve 114, permitting gastric content to reflux into the esophagus 120.

[0097] Additionally, the presence of hiatal hernia further exacerbates the disruption. A hiatal hernia can involve the protrusion of the stomach 109 through the diaphragmatic hiatus, leading to a distortion in the anatomical relationship between the esophagus 120 and stomach 109. This distortion contributes to the dislocation of the GEJ and the flap valve 114 mechanism. As a result, the closure of the flap valve 114 is compromised, allowing gastric content to more easily reflux into the esophagus 120. In cases of hiatal hernia, the upward translocation and closure by elongation of the flap valve 114 are hindered. The altered anatomical arrangement and w eakened support prevent effective closure, leads to increased potential for reflux even during normal swallowing.

[0098] The improved devices and methods described herein can be implemented endoscopically, laparoscopically, or through a hybrid approach. The endoscope 102 illustrated in FIG. 1 can be a gastrointestinal endoscope used to examine the gastrointestinal tract, including the esophagus 120, stomach 109, and upper part of the small intestine. The elongation members, anchor members, and prosthetic devices described herein can be positioned to improve flap valve 114 function.

[0099] For example, in endoscopic deployment within the gastrointestinal tract, an endoscopic instrument (e.g., endoscope 102) is used to introduce and position the implant (e.g., improved elongation members, anchor members, and / or prosthetic flap valve devices disclosed herein) in the GEJ. This procedure includes the oral insertion of an endoscope 102 under sedation or anesthesia of the subject. The endoscope provides realtime visualization of the implant, which can be loaded onto a dedicated delivery system.Atorney Docket No. 07039-2362WO1 / 2023-018 The implant is navigated through a working channel of the endoscope to access the targeted site within the GEJ tract or could be deliver over or adjacent the endoscope. In some embodiments, a single channel endoscope is utilized. In other embodiments, a multiple channel endoscope is utilized for the delivery’ of the device disclosed herein. In some embodiments, an endoscopic robotic system is used to deliver the devices or prosthesis disclosed herein. After positioning, a user can deploy the implant, which could encompass stents, clips (through or over the scope), sutures, staples, plications, or other relevant devices, ensuring precise placement and functionality. The dynamic endoscopic view substantiates the implant's proper positioning and efficacy. The improved elongation members, anchor members, and / or prosthetic flap valve devices described herein provide the advantage of minimal invasiveness for implantation which can provide expedited recuperation. Endoscopic deployment is described further with reference to FIG. 16 below.

[0100] In some embodiments, the improved elongation members, anchor members, and / or prosthetic flap valve devices disclosed herein are implanted to a subject using laparoscopic techniques or through a hybrid endoscopic and laparoscopic approach. For instance, laparoscopic implantation within the GEJ tract, includes the utilization of small incisions and laparoscopic instruments to introduce and position an implant (e.g.. the improved elongation members, anchor members, and / or prosthetic flap valve devices disclosed herein) within the GEJ tract. To start, air is gently blown into the abdomen to make room. Then, small tubes called trocars are carefully placed in the abdomen while the subject is sleeping from the anesthesia. A laparoscope, featuring a camera and light source, is introduced through an initial trocar, providing a comprehensive visual field. Through additional trocars, precise manipulation of laparoscopic instruments occur, enabling the navigation and accurate placement of the implant(s) within the GEJ tract. The implant, often integrated into a purpose-built delivery system, is adeptly positioned under real-time visualization. The medical team then actively engages in implant deployment, ensuring optimal orientation and integration. The laparoscopic view confirms the implant's exact placement and functionality before the gradual withdrawal of instruments and trocars. In some examples, the laparoscopic equipment can deliver an anchoring element, such as clip, suture, plication, stent to bolster or anchor the devices disclosed herein. In some implementations, the laparoscopic deployments are described further with reference to FIG. 17 below. In some implementations, a robotic system canAtorney Docket No. 07039-2362WO1 / 2023-018 be used during a laparoscopic deployment. For example, a robotic system as illustrated in FIG. 35 can be used during a laparoscopic delivery of a prosthetic valve system.

[0101] In some embodiments, the improved elongation members, anchor members, and / or prosthetic flap valve devices described herein can be implanted using a combined hybrid approach involving both endoscopic and laparoscopic techniques. For example, in some embodiments, the prosthetic flap valve, elongation member, anchor member, or combinations thereof are delivered using a cooperative hybrid transmural approach in which a first anchoring element is advanced from the peritoneal or abdominal cavity by laparoscopic, robotic, or open surgical access through or into the gastric or gastroesophageal wall and is received, captured, coupled, cinched, locked, docked, or otherwise engaged with a second receptive element delivered endoscopically from the luminal side, thereby creating a full-thickness transmural fixation construct for securing, tensioning, orienting, suspending, or adjusting the flap valve system at the gastroesophageal junction; in some embodiments the coupled elements comprise mating magnets, suture capture elements, clips, pledgets, anchors, eyelets, docking ports, snareable members, threaded members, or interlocking mechanical features, and in some embodiments this cooperative anchoring permits selective repositioning, re-tensioning, reinforcement, or removal after implantation.

[0102] In some embodiments, the implanted prosthetic flap valve system, elongation members, and / or anchor constructs are configured to permit post-implant adjustability and revision, including endoscopic, laparoscopic, robotic, or combined access to tighten, loosen, re-tension, reorient, reposition, partially disengage, or remove one or more components after initial deployment; such adjustability may be achieved via releasable coupling interfaces, adjustable-length members, cinching mechanisms, magnetic interfaces, suture-based systems, or reversible locking features, thereby enabling optimization of flap valve function, patient tolerance, and reflux control over time without requiring full device explantation.

[0103] For instance, in a hybrid procedure that involves both endoscopy and laparoscopy for implantation within the GEJ tract, small incisions are made, and laparoscopic instruments are used to carefully introduce and position the implant (such as the improved elongation members, anchor members, and / or prosthetic flap valve devices described herein) within the GEJ tract. This process begins with a small amount of air is introduced into the abdomen to create a working space.Atorney Docket No. 07039-2362WO1 / 2023-018 Approximately concurrently, an endoscope is deployed. A slender endoscope, equipped with a camera and light source, is introduced through the mouth and guided into the esophagus. This endoscope serves to provide an internal view of the esophagus and the GEJ, enabling accurate guidance for the subsequent steps. Subsequently, slender tubes known as trocars are inserted into the abdominal area while the patient is under the influence of anesthesia.

[0104] Through the trocars, laparoscopic instruments are maneuvered, allowing for navigation and the accurate placement of the implant(s) within the GEJ tract. The implant, can be integrated into a purpose-built delivery system, is positioned with realtime visual monitoring. The combined endoscopic and laparoscopic perspective facilitates verification of the implant's exact positioning and functional effectiveness before the gradual removal of instruments and trocars. This hybrid approach effectively leverages both endoscopic and laparoscopic techniques, thereby ensuring the successful and secure implantation within the GEJ tract. An anchoring element, such as clip, suture, plication, or stent can be utilized to bolster or anchor the devices disclosed herein. Hybrid deployments are described further with reference to FIG. 18 below.

[0105] FIG. 3 depicts a cross-section schematic 301 of an endoscope 302 inside a stomach 309 and GEJ (broken circle 311) with a flap valve 314 in a closed position. Structures discussed in reference to FIG. 3 can include the same features and details as those described in reference to FIGS. 1-2.

[0106] The flap valve 314 is a 180° musculomucosal connective tissue fold that is opposite to the lesser curvature 334 of the stomach 309 as viewed with the endoscope 302. The flap valve 314 is in a closed position such that the tissue constructs of the flap valve 314 are elongated toward the lesser curvature 334 of the stomach 309. Under normal operation, the elongation of the flap valve 314 in a closed position can be about 1.0-2.5 cm. The example depicted by FIG. 3 shows an endoscope 302 that has traversed the esophagus 320 such that the GEJ 311 and flap valve 314 can be viewed from below the esophagus 320. When a subject has GERD and / or hiatal hernia, the elongation of the tissue of the flap valve 314 can be shorter than 1.0-2.5 cm and / or be misaligned such that the flap valve 314 does not exist or is not functioning.

[0107] FIG. 4 depicts a cross-section schematic 401 of the endoscope 402 inside the stomach 409 and GEJ (broken circle 411) of FIG. 3 with the flap valve 414 in an openAtorney Docket No. 07039-2362WO1 / 2023-018 position. Structures discussed in reference to FIG. 4 can include the same features and details as those described in reference to FIGS. 1-3.

[0108] The tissue construct that makes up the flap valve 414 are shortened by upward translocation when the flap valve 414 is in an open position. The open position depicted by FIG. 4 provides a pathway between the stomach 409 and the esophagus 420. Under normal operation, the open position is momentary and the flap valve 414 will move to a closed position (e.g., as described in FIG. 3) via the elongation of the flap valve 414 after a swallowing movement has commenced. The example depicted by FIG. 4 shows an endoscope 402 that has traversed the esophagus 420 such that the GEJ 411 and flap valve 414 are viewed from below the esophagus 420. When a subject has GERD and / or hiatal hernia, the flap valve 414 can be misaligned such that there is a persistent opening where gastric acid or other substance can flow to the esophagus 420.

[0109] FIG. 5 depicts an endoscopic ultrasound image 505 of a stomach and gastroesophageal junction of a subject. Structures discussed in reference to FIG. 5 can include the same features and details as those described in reference to FIGS. 1-4. FIG. 5 is an image of a GEJ as viewed from an endoscopic ultrasound probe 544. For example, the view shown in FIG. 5 can be that as depicted in FIGS. 3-4. FIG. 5 describes the tissues that make up the construct of the flap valve (e.g., any of the flap valves described herein).

[0110] The connective tissue of the flap valve 550 is a type of tissue that provides structural support and helps bind different components together. In the context of the flap valve at the gastroesophageal (GE) junction 546 (e.g.. the GEJ), connective tissue plays a role in maintaining the integrity and flexibility of the flap valve, contributing to its function in preventing reflux of stomach contents into the esophagus. The muscularis propria of the gastric cardia 548 is a layer of smooth muscle in the gastrointestinal tract. In the context of the gastric cardia, which is the region connecting the esophagus to the stomach, the muscularis propria consists of muscle fibers that facilitate the movement of ingested food from the esophagus into the stomach. It assists in the mechanical breakdown of food and propels it further along the digestive tract. The flap valve (e.g., the flap valve 114, 214, 314, 414) of the gastroesophageal (GE) junction 546 is a functional construct rather than a standalone tissue. It involves a combination of the angle of His, the configuration of the gastroesophageal junction, and the functionality of the circular esophageal muscles of the esophagus. This complex interaction forms a barrierAtorney Docket No. 07039-2362WO1 / 2023-018 that prevents stomach content from flowing back into the esophagus, helping to avoid issues like GERD. The muscularis propria of the lower esophagus 542 is a layer of smooth muscle that aids in the movement of food from the esophagus into the stomach. This muscular layer contracts in coordinated waves (peristalsis) to push food downward through the esophagus and into the stomach.

[0111] The tissues that make up the construct that is the flap valve (e.g., flap valve 114 of FIG. 1) work as a unit to lengthen and shorten (open or close) the muscles and tissues of the flap valve during swallowing events (e.g., as depicted in FIGS. 3 and 4). For example, when swallowing occurs, a complex series of muscle contractions and movements take place to propel food from the mouth to the stomach.

[0112] FIG. 6 depicts a cross-section view of an example elongation member 660 inside the stomach and gastroesophageal junction. The structures of FIG. 6 can be part of an overall prosthetic flap valve system and can include the same features and details as those described in reference to FIGS. 1-5. In the example embodiments depicted by FIG. 6, the native (e.g., non-prosthetic) flap valve 614 is elongated by the implantation of an elongation member 660 anchored to the gastric wall by one or more anchor members 662 and 662' in an area that is between the (high-pressure zone) HPZ and Z line.

[0113] The HPZ is a specialized area within the GEJ. The HPZ is characterized by a higher resting pressure compared to the surrounding esophageal and gastric areas. This higher pressure plays an important role in preventing the backflow of stomach contents into the esophagus, thereby helping to prevent gastroesophageal reflux. The flap valve is part of the HPZ, and the intrabdominal segment of the esophagus is part of the HPZ.

[0114] The Z line is an anatomical landmark that demarcates the boundary between the esophagus and the stomach within the gastrointestinal tract. It represents the point where the specialized squamous epithelium of the esophagus transitions into the columnar epithelium of the stomach lining. The Z line position is dynamic and can vary’ based on factors such as the individual’s physiology and the presence of certain pathologies. For instance, in the presence of GERD, the Z line may shift upwards, a condition known as "short-segment Barrett’s esophagus," where columnar epithelium extends into the lower esophagus due to chronic acid exposure.

[0115] In endoscopy and medical imaging, the Z line serves as a reference point for evaluating the health of the esophagus and diagnosing conditions that may affect the gastroesophageal junction. It also plays a role in defining the length of Barrett’sAtorney Docket No. 07039-2362WO1 / 2023-018 esophagus, a condition characterized by the abnormal extension of columnar epithelium into the esophagus.

[0116] The severity of gastroesophageal disorders can be evaluated to determine an effective intervention. As mentioned above, in some cases, the severity of GERD is based on the degree of anatomical disruption and physiological dysfunction of the gastroesophageal junction (GEJ). The Hill classification helps to assess the GEJ antireflux barrier and guide treatment decisions. In some cases, the GERD or hernia severity may be graded low (e.g., grade one or two). In these cases, intervention may be effective without a prosthetic flap valve. Instead, implantable devices configured to encourage full closure of a native flap valve tissue can be implemented by implanting an elongation member 660 to the native flap valve 614 and a gastric wall. Such implementations are described in connection with FIGS. 6-9.

[0117] The one or more anchor members 662 / 662' can made from any suitable material. For example, an anchor member 662 / 662' can be a magnet, a helical structure fastener, a clip structure, a tissue anchor, an anchoring ring, a needle pin, a screw, a suture, a plication basket, or a staple or any combination thereof. The one or more anchor members 662 / 662' can be configured to couple a first end 661 of the elongation member to the gastric wall of a subject and the second end 661' of the elongation member 660 to the flap valve 614.

[0118] An elongation member 660 can be made from any biocompatible material or configuration that is sufficient to bias the flap valve 614 in the closed position. For example, an elongation member 660 can be a compression spring, a torsion spring, an extension spring, an elastic band, or any elongating material (e.g., a biocompatible polymer or silicone). In some embodiments, the elongation member 660 is a compression spring that is implanted between a fixed point on the gastric wall and the flap valve 614. In this instance, when the flap valve 614 is open, the compression spring is compressed, storing potential energy that forces the flap valve 614 closed when released.

[0119] In another embodiment, the elongation member 660 is a torsion spring that is implanted on a central axis of the flap valve 614 and implanted to the gastric wall. In this case, when the when the flap valve 614 is open, the torsion spring is twisted, and its restoring torque brings the flap valve 614 back to the closed position.

[0120] In another embodiment, the elongation member 660 is an extension spring that is implanted on the gastric wall and the flap valve 614 in a stretched position (underAtorney Docket No. 07039-2362WO1 / 2023-018 tension) when the flap valve 614 is closed. In this case, when the flap valve is opened, the spring contracts, providing a force that pulls the flap valve 614 closed when released.

[0121] In the example embodiment show n by FIG. 6, a first anchor member 662 is coupled to a first end 661 of the elongation member 660 and the gastric wall proximal to the lesser curvature 634. A second anchor member 662' is coupled to a second end 661' of the elongation member 660 and the flap valve 614. The example embodiment described by FIG. 6 utilizes an elongation member 660 that can pull the flap valve 614 in a closed position while allowing normal swallowing action that opens the flap valve 614. In some embodiments, the elongation member 660 an extension spring. For example, the elongation member 660 can be an extension spring that is in a stretched configuration when the elongation member 660 is coupled on the first end 661 to the gastric wall and on the second end 661' to the flap valve 614. When the flap valve 614 moves to an open position responsive to a swallowing motion, the length of the flap valve 614 shortens thus increasing the distance between the first anchor member 662 and the second anchor member 662'. In this instance, the elongation member 660 (e.g., the extension spring) will increase in tension as the flap valve 614 opens and will pull the flap valve 614 back to a closed position when the swallowing action is complete.

[0122] FIG. 7 depicts a perspective view of the example elongation member of FIG. 6 inside the stomach and gastroesophageal junction. The structures discussed in reference to FIG. 7 can include the same features and details as those described in reference to FIGS.

[0123] 1-6. In the example embodiments depicted by FIG. 7, more than one elongation member 760A and 760B are coupled to the native (e.g., non-prosthetic) flap valve 714. For example, the flap valve 714 is secured closed in an elongated position by the implantation of a plurality of elongation members 760A and 760B anchored to the gastric w all by one or more anchor members 762A, 762A', 762B, and 762B' in an area that is between the HPZ and Z line (see FIG. 6).

[0124] In the example embodiment shown by FIG. 7. a first anchor member 762A is coupled to a first end 761 A of a first elongation member 760A and the gastric wall proximal to the lesser curvature 734. A second anchor member 762A' is coupled to a second end 761 A' of the elongation member 760A and the flap valve 714. A third anchor member 762B is coupled to a first end 761B of a second elongation member 760B and the gastric wall proximal to the lesser curvature. A fourth anchor member 762B' is coupled to a second end 761B' of the second elongation member 760B and the flap valve 714. TheAtorney Docket No. 07039-2362WO1 / 2023-018 prosthetic elongation members 760A-B and anchor members 762A-B can be implanted and positioned using endoscopic, laparoscopic, or hybrid approaches. In endoscopic procedures, these components are introduced and placed within the gastroesophageal junction using visual guidance from endoscopic tools. Laparoscopic methods involve the precise positioning of these members through small incisions using specialized laparoscopic instruments. A hybrid approach combines endoscopic and laparoscopic techniques for comprehensive implantation, optimizing the functionality of the prosthetic elements within the gastroesophageal junction's dynamics.

[0125] The example embodiment described by FIG. 7 utilizes a plurality of elongation members 760A and 760B that can pull the flap valve 714 toward the lesser curvature 734 in a closed position while allowing normal swallowing action. In some embodiments, the elongation member 760A and / or 760B an extension spring. Such interventions can be effective for GERD and hiatal hernia disorders that are mild to moderate in severity.

[0126] FIG. 8 depicts a cross-section view of another example elongation member 860 inside the stomach and gastroesophageal junction. The structures of FIG. 8 can be part of an overall prosthetic flap valve system and can include the same features and details as those described in reference to FIGS. 1-7. In the example embodiments depicted by FIG.

[0127] 8, the native (e.g., non-prosthetic) flap valve 814 is elongated by the implantation of an elongation member 860 anchored to the gastric wall by one or more anchor members 862 and 862' in an area that is between the HPZ and Z line.

[0128] In the example embodiment shown by FIG. 8, a first anchor member 862 is coupled to a first end 861 of the elongation member 860 and the gastric wall proximal to the greater curvature 832. A second anchor member 862' is coupled to a second end 861' of the elongation member 860 and the flap valve 814. The example embodiment described by FIG. 8 utilizes an elongation member 860 that can push the flap valve 814 in a closed position toward the lesser curvature 834 while allowing normal swallowing action that opens the flap valve 814. In some embodiments, the elongation member 860 a compression spring. For example, the elongation member 860 can be a compression spring that is in a non-compressed configuration when the elongation member 860 is in a closed position and coupled on the first end 861 to the gastric wall and on the second end 86T to the flap valve 814. When the flap valve 814 moves to an open position responsive to a swallowing motion, the length of the flap valve 814 shortens thus decreasing the distance between the first anchor member 862 and the second anchor member 862'. InAtorney Docket No. 07039-2362WO1 / 2023-018 this instance, the elongation member 860 (e.g., the compression spring) will increase in tension as the flap valve 814 opens and will push the flap valve 814 back to a closed position when the swallowing action is complete. Although two elongation members 860A-860B are depicted in FIG. 8, more or less than two can be implanted.

[0129] FIG. 9 depicts a perspective view of the example elongation member of FIG. 8 inside the stomach and gastroesophageal junction. The structures discussed in reference to FIG. 9 can include the same features and details as those described in reference to FIGS.

[0130] 1-8. In the example embodiments depicted by FIG. 9, more than one elongation member 960 is coupled to the native (e.g., non-prosthetic) flap valve 914. For example, the flap valve 914 is secured closed in an elongated position by the implantation of a plurality of elongation members 960A-960D and each respective elongation member 960A-960D is anchored to the gastric wall by one or more anchor members 962A, 962A', 962B, 962B', 962C, 962C'. 962D, and 962D' in an area that is between the HPZ and Z line (see FIG. 8).

[0131] In the example embodiment shown by FIG. 9, a first anchor member 962A is coupled to a first end 961 A of a first elongation member 960A and the gastric wall proximal to the greater curvature 932. A second anchor member 962A' is coupled to a second end 961 A' of the elongation member 960A and the flap valve 914. A third anchor member 962B is coupled to a first end 96 IB of a second elongation member 960B and the gastric wall proximal to the greater curvature 932. A fourth anchor member 962B' is coupled to a second end 961B' of the second elongation member 960B and the flap valve 914. A fifth anchor member 962C is coupled to a first end 961C of a third elongation member 960C and the gastric wall proximal to the greater curvature 932. A sixth anchor member 962C' is coupled to a second end 961 C' of the third elongation member 960C and the flap valve 914. A seventh anchor member 962D is coupled to a first end 96 ID of a fourth elongation member 960D and the gastric wall proximal to the greater curvature 932. An eighth anchor member 962D' is coupled to a second end 96 ID' of the fourth elongation member 960D and the flap valve 914. Although four elongation members 960A-960D are depicted in FIG. 9, more or less than four can be implanted.

[0132] The example embodiment described by FIG. 9 utilizes a plurality of elongation members 960A-D that can push the flap valve 914 away from the greater curvature 932 to a closed position while allowing normal swallowing action. In some embodiments, one or more of the elongation members 960A-960D are a compression spring. SuchAtorney Docket No. 07039-2362WO1 / 2023-018 interventions can be effective for GERD and hiatal hernia disorders that are mild to moderate in severity.

[0133] The prosthetic elongation members 960A-960D and anchor members 962A-962D can be implanted and positioned using endoscopic, laparoscopic, or hybrid approaches. In endoscopic procedures, these components are introduced and placed within the gastroesophageal junction using visual guidance from endoscopic tools. Laparoscopic methods involve the precise positioning of these members through small incisions using specialized laparoscopic instruments. A hybrid approach combines endoscopic and laparoscopic techniques for comprehensive implantation, optimizing the functionality of the prosthetic elements within the gastroesophageal junction's dynamics.

[0134] FIG. 10 depicts a cross-section view of an example prosthetic flap valve system 1007 inside a stomach and gastroesophageal junction. The structures discussed in reference to FIG. 10 can include the same features and details as those described in reference to FIGS. 1-9. In the example embodiments depicted by FIG. 10, a prosthetic flap valve 1015 is implanted to the tissue of the residual native flap valve or tissue of the subject and secured with an anchor member 1017. The opening and closing functions are facilitated with a hinge or hinge-like mechanism 1019. In the embodiment shown by Fig.

[0135] 10, the prosthetic flap valve system 1007 is positioned in an area that is between the HPZ and Z line.

[0136] The prosthetic flap valve 1015 can be made from any suitable material. For example, the prosthetic flap valve 1015 can be made a prosthetic material selected from polymer, silicone, hydrogel, collagen-based material, a composite material, or a biological material (e.g., animal tissue, cultured tissue, or cadaver tissue). The anchor member 1017 can include any of the anchor members described herein. The hinge 1019 can be made from any biocompatible flexible material such as polymer, silicone, hydrogel, collagen-based material, a composite material, or a biological material (e.g., animal tissue, cultures tissue, or cadaver tissue). In some embodiments, the hinge 1019 is a torsion spring. In such embodiments, a torsion spring hinge 1019 is implanted such that the central axis around which the hinge 1019 rotates opens the prosthetic flap valve 1015 to an open position toward the lesser curvature 1034. When the force causing the rotation is removed (e.g., when the prosthetic flap valve 1015 is released), the torsion spring's stored energy is released, creating a closing force that returns the hinge 1019 to its closed position. The embodiment disclosed in FIG. 10 shows an example of a prosthetic flapAtorney Docket No. 07039-2362WO1 / 2023-018 valve 1015 that opens toward the lesser curvature 1034 when a swallowing operation takes place and closes by way of the hinge 1019.

[0137] During a swallowing operation, food or liquid can apply enough pressure to the prosthetic hinge 1019 that the hinge 1019 facilitates the prosthetic flap valve 1015 to open in the direction away from the lesser curvature 1034 and the food or liquid will pass into the stomach. The hinge 1019 operation opens and closes around a pivot point that allows rotational movement between prosthetic flap valve 1015 and the anchor member 1017. The hinge 1019 enables the prosthetic flap valve 1015 to open and close around the pivot point. In this case, the hinge 1019 is designed to bias the prosthetic flap valve 1015 to a closed position. In some embodiments, a prosthetic flap valve 1015 is secured in the closed position by way of an additional anchor member.

[0138] In some embodiments, the hinge 1019 is a torsion spring. In such embodiments, when the force causing the rotation is removed (e.g., when the food passes into the stomach), the torsion spring's stored energy is released, creating a closing force that returns the hinge 1019 to its closed position. In some embodiments, the hinge 1019 is living hinge that includes a flexible section of a solid material (e.g., plastic or silicone) that acts as a hinge between two structures. In such embodiments, during a swallowing operation, when food has passed into the stomach, a living hinge 1019 stored energy is released, creating a closing force that returns the hinge 1019 to its closed position. A living hinge 1019 relies on the material's inherent flexibility7and elastic properties to allow movement and return to a closed position. In some embodiments, additional anchor members can be included in the prosthetic flap valve system 1007 to secure the prosthetic flap valve 1015 closed (described in greater detail in connection with FIG. 11.

[0139] FIG. 11 depicts a perspective view of the example prosthetic flap valve system of FIG. 10 inside a stomach and gastroesophageal junction. The structures discussed in reference to FIG. 11 can include the same features and details as those described in reference to FIGS. 1-10. The prosthetic flap valve system 1107 includes a prosthetic flap valve 1115 that can open and close in the direction of the lesser curvature 1134. The prosthetic flap valve 1115 can include a hinge 1119 and an anchor member 1117 as described in connection with FIG. 10. In some example embodiments, a prosthetic flap valve 1115 can optionally include a gasket 1123 and / or one or more closing anchor members 1121a-g.Atorney Docket No. 07039-2362WO1 / 2023-018 For example, a prosthetic flap valve 1115 can include a gasket 1123 that is coupled to a border 1131 of the prosthetic flap valve 1115 to facilitate a seal between the prosthetic flap valve 1115 and the tissue of the subj ect. The border 1131 is partially defined by a first end 1133 and a second end 1135. In some embodiments, the border 1131 is an annular border, which demarcates the interface between the prosthetic flap valve 1115 structure and the surrounding tissue of the subject. The border 1131 exhibits a predetermined geometric profile, characterized by its dimensions, curvature, and material properties. The border 1131 can encompass an outer sealing (e.g., the gasket 1123) component designed to ensure proper attachment and sealing with the host vessel, while an inner anchoring component facilitates secure integration within the anatomical site. The border's 1131 design and configuration are tailored to optimize hemodynamic performance, structural integrity, and long-term biocompatibility, thereby enhancing the overall functionality and longevity of the prosthetic flap valve 1115.

[0140] In some examples, the border 1131 is an irregular border 1131 shape, evoking a clamshell-like form. The border 1131 exhibits anon-symmetrical lobe, resembling the halves of an opened clamshell. The lobe extends outward from a central axis and encompass the prosthetic flap valve 1115 orifice. The irregularity of the border 1131 is characterized by its varying curvature, dimensions, and contour along the perimeter, imparting a non-uniform profile to the prosthetic flap valve 1115. This distinctive border 1131 structure offers potential benefits in terms of enhanced fluid dynamics, tissue interaction, and adaptive sealing, thereby contributing to improved overall prosthetic flap valve 1115 performance and biocompatibility.

[0141] The first end 1133 of the prosthetic flap valve 1115 is adjacent to the greater curvature 1132 and the second end 1135 opens toward the lesser curvature 1134. The gasket 1123 is under the prosthetic flap valve 1115 and provides a seal between the prosthetic flap valve 1115 and the tissue of the subject when in the closed position. The gasket 1123 can be made from any suitable material. For example, the gasket 1123 can be made from medical-grade silicone, polyurethane, polymethyl methacrylate, polyethylene, polytetrafluoroethylene, bioabsorbable polymers, hydrogels, collagen-based materials, or elastomers.

[0142] In some embodiments, the prosthetic flap valve 1115 can optionally include one or more closing anchor members 1121a-g to facilitate the prosthetic flap valve 1115 closing. The one or more closing anchor members 1121a-g can be coupled to the secondAtorney Docket No. 07039-2362WO1 / 2023-018 end 1135 of the prosthetic flap valve 1115. The closing anchor members 1121a-g can be made from any appropriate material. For example, the one or more closing anchor members 1121 a-g can be made from a magnet, a helical structure fastener, a clip structure, a tissue anchor, a needle pin, a screw, a suture, a plication basket, or a staple. In some embodiments, the one or more closing anchor members 1121a-g can be a magnet. In such embodiments, a first pole of a magnet can be implanted to the tissue of the subject and a second pole of the magnet can be included in the second end 1135 of the prosthetic flap valve 1115. After an open operation, the hinge 1119 can facilitate closure as described above, and the one or more anchor members 1121a-g can engage to secure closure of the prosthetic flap valve 1115.

[0143] The prosthetic flap valve 1115, closing anchor members 1121a-g, anchor member 1117, and / or hinge 1019 can be implanted and positioned using endoscopic, laparoscopic, or hybrid approaches. In endoscopic procedures, these components are introduced and placed within the gastroesophageal junction using visual guidance from endoscopic tools. Laparoscopic methods involve the precise positioning of these members through small incisions using specialized laparoscopic instruments. A hybrid approach combines endoscopic and laparoscopic techniques for comprehensive implantation, optimizing the functionality of the prosthetic elements within the gastroesophageal junction's dynamics. In some embodiments, the prosthetic flap valve system 1107 can be implanted during a bariatric surgical procedure.

[0144] FIG. 12 depicts a cross-section view of another example prosthetic flap valve system 1209 inside a stomach and gastroesophageal junction. The structures discussed in reference to FIG. 12 can include the same features and details as those described in reference to FIGS. 1-11. The embodiment disclosed in FIG. 12 shows an example of a prosthetic flap valve 1215 that includes an opening toward the lesser curvature 1234. During a swallowing event, food or liquid passes through the opening to the stomach.

[0145] In this embodiment, the opening is a slit in the prosthetic flap valve 1215 at a portion where the prosthetic flap valve 1215 meets the gastric wall of the subject. Said differently, the prosthetic flap valve 1215 can be coupled to the gastric wall of a subject except for a portion toward the lesser curvature 1234. The uncoupled portion of the prosthetic flap valve 1215 toward the lesser curvature 1234 can momentarily separate from the gastric wall such that food can pass to the stomach.Atorney Docket No. 07039-2362WO1 / 2023-018 In the example embodiments depicted by FIG. 12, a prosthetic flap valve 1215 is implanted to the tissue of the residual native flap valve or tissue of the subject and secured with an anchor member 1217. In the embodiment shown by Fig. 12, the prosthetic flap valve system 1207 is positioned in an area that is between the HPZ and Z line.

[0146] The prosthetic flap valve 1215 can be made from any suitable material. For example, the prosthetic flap valve 1215 can be made a prosthetic material selected from polymer, silicone, hydrogel, collagen-based material, a composite material, or a biological material (e.g., animal tissue, cultured tissue, or cadaver tissue). The anchor member 1217 can include any of the anchor members described herein.

[0147] During a swallowing operation, food or liquid can apply enough pressure to the prosthetic flap valve 1215 such that the opening of the prosthetic flap valve 1215 separates from the gastric wall and the food or liquid will pass into the stomach.

[0148] FIG. 13 depicts a perspective view of the example prosthetic flap valve system 1319 of FIG. 12 inside a stomach and gastroesophageal junction. The structures discussed in reference to FIG. 13 can include the same features and details as those described in reference to FIGS. 1-12. The prosthetic flap valve 1315 includes a first end 1333 and a second end 1335. The first end 1333 couples the prosthetic flap valve 1315 to the gastric wall toward the greater curvature 1332. The second end 1335 is not secured to the gastric wall and the unsecured portion of the prosthetic flap valve 1315 is positioned toward the lesser curvature 1334 and forms an opening. During a swallowing operation, food or liquid applies pressure to the prosthetic flap valve 1315 such that it can pass through the opening and into the stomach.

[0149] In some embodiments, the anchor members 1317a-c are aligned within a frame 1370 that couples the prosthetic flap valve 1315 to the gastric wall adjacent to the greater curvature 1332. For example, the anchor members 1317a-c can be aligned within a frame 1370 that is solid or partially solid and configured to secure the first end 1333 of the prosthetic flap valve 1315 to the gastric wall adjacent to the greater curvature 1332. In some embodiments, the frame 1370 is configured to keep the prosthetic flap valve 1315 taunt. For example, the prosthetic flap valve 1315 can include a membrane 1372. The membrane 1372 can be flexible and made from one or more flexible materials selected from silicone, hydrogel, biocompatible fabric, or biocompatible polymer. The flexibility of the membrane 1372 is taunt but flexible such that food can pass through the openingAtorney Docket No. 07039-2362WO1 / 2023-018 during a swallow operation. The frame 1370 can be in a semicircle or horseshoe shape. A semicircle or horseshow shape can couple the prosthetic flap valve 1315 to the gastric wall such that the entrance to the esophagus is partially surrounded.

[0150] The prosthetic flap valve 1315, anchor members 1319a-c, and frame 1370 can be implanted and positioned using endoscopic, laparoscopic, or hybrid approaches. In endoscopic procedures, these components are introduced and placed within the gastroesophageal junction using visual guidance from endoscopic tools. Laparoscopic methods involve the precise positioning of these members through small incisions using specialized laparoscopic instruments. A hybrid approach combines endoscopic and laparoscopic techniques for comprehensive implantation, optimizing the functionality of the prosthetic elements within the gastroesophageal junction's dynamics. In some embodiments, the prosthetic flap valve system 1307 can be implanted during a bariatric surgical procedure.

[0151] FIG. 14 depicts a cross-section schematic of an endoscopic ultrasound delivering a flap-valve augmentation prosthetic elements to the gastroesophageal junction. The structures discussed in reference to FIG. 14 can include the same features and details as those described in reference to FIGS. 1-13. The example embodiment of FIG. 14 includes the injection of elastic coils 1476. In some embodiments, the implantation of the elastic coils 1476 can be combined with a bulking agent (e.g., synthetic or biologic). For example, endoscopic imaging can be used to identify the native flap valve 1414 and one or more elastic coils 1476 with or without a bulking agent can be injected into the tissue of a subject to elongate the native flap valve 1414.

[0152] Methods of implanting elongating members (e.g., any of the elongating members described herein) and prosthetic flap valve systems (e.g., any of the prosthetic flap valve systems described herein) are disclosed herein. In some embodiments, the methods include identifying a subject as having GERD and / or hiatal hernia. For example, a subject may undergo testing to determine that they have GERD and / or hiatal hernia. The methods may further include, determining a severity of the GERD and / or hiatal hernia with respect to the GEJ and flap valve function. Based on that determination, the methods can further include identify ing a therapeutic treatment.

[0153] In some embodiments, the methods can include endoscopically implanting one or more elongation members (e.g., any of the elongating members described herein) and one or more anchor members (e.g., any of the anchor members described herein) to the gastricAtorney Docket No. 07039-2362WO1 / 2023-018 wall and flap valve of the subject. In some embodiments, implanting one or more elongation members and one or more anchor members is based in part on the severity of the GERD and / or hiatal hernia.

[0154] FIG. 15 illustrates a prosthetic flap system 1500 installed on an endoscope 1502 for an endoscopic delivery of the prosthetic flap system 1500. For example, the endoscope can be a gastrointestinal endoscope used to examine the gastrointestinal tract, including the esophagus, stomach, and upper part of the small intestine. The prosthetic flap system 1500 can be restrained and held to the endoscope 1502 by a band or sheath during delivery. Once the prosthetic flap system 1500 reaches a desired target within the gastrointestinal tract, the prosthetic flap system 1500 can be released, e.g., via a release wire as described further relative to FIG. 25.

[0155] For example, in endoscopic deployment within the gastrointestinal tract, an endoscopic instrument (e.g., endoscope 1502) is used to introduce and position the prosthetic flap system 1500 in the GEJ (e.g., valve tissue). This procedure includes the oral insertion of an endoscope 1502 under sedation or anesthesia of the subject. The endoscope provides real-time visualization of the implant, w hich can be loaded onto the endoscope 1502. The prosthetic flap system 1500 is navigated through a working channel of the endoscope to access the targeted site (e.g., native flap valve tissue) within the GEJ tract or could be deliver over or adjacent the endoscope. In some embodiments, a single channel endoscope is utilized. In other embodiments, a multiple channel endoscope is utilized for the delivery' of the prosthetic flap system 1500. In some embodiments, an endoscopic robotic system is used to deliver the prosthetic flap system 1500 (or other systems and devices disclosed herein). For example, the robotic system can include a camera and articulating arms. One example of a robotic system that can be used to deliver the prosthetic flap system 1500 is illustrated in FIG. 35.

[0156] FIG. 16 illustrates the prosthetic flap system 1500 of FIG. 15 before being installed on an endoscope. The prosthetic flap system 1500 can include a prosthetic flap valve 1504, a hinge 1506, and an anchor member 1508. For example, the prosthetic flap system 1500 can be similar to other prosthetic flap systems described herein (e.g., as described in connection with FIG. 10). In some example embodiments, the prosthetic flap system 1500 can optionally include a gasket and / or one or more closing anchor members. In the illustrated embodiment, the anchor 1508 includes a clip, but in other embodiments can include any of the other anchor members described herein.Atorney Docket No. 07039-2362WO1 / 2023-018 FIG. 17 illustrates another embodiment of an endoscope 1700. The endoscope 1700 does not have a prosthetic flap system installed on the endoscope 1700. The endoscope 1700 can include a single channel endoscope. In other embodiments, a multiple channel endoscope is utilized. In some embodiments, an endoscopic robotic system is used. For example, the robotic system illustrated in FIG. 35 can be used for an endoscopic delivery of a prosthetic valve system.

[0157] FIG. 18 illustrates an example of a clip 1800 for attaching a prosthetic flap valve system to the gastroesophageal junction. The clip 1800 is one example of an anchor member that can be used as described herein. The prosthetic flap valve system can be similar to the prosthetic flap valve system 1500 of FIG. 15 or any of the other devices and systems described herein. The clip 1800 includes an engagement surface 1802 configured to engage the anchoring site of the gastroesophageal junction. The engagement surface 1802 can include, e.g., protrusions configured to catch the tissue and maintain engagement with the tissue. The anchoring site of the gastroesophageal junction is illustrated with reference to FIG. 19. The clip 1800 also includes a retractor 1804 configured to be retracted relative to the engagement surface 1802. In the illustrated embodiment, the retractor 1804 includes a spring, but in other embodiments may or may not include a spring. When the retractor 1804 is retracted relative to the engagement surface 1802, the tissue of the anchoring site is drawn into the clip 1800, and a greater surface area of tissue contacts the engagement surface 1802.

[0158] The clip 1800 can be positioned at the anchoring site of the gastroesophageal junction using an instrument (e.g., an endoscope). FIG. 19 depicts the example clip 1800 attaching to the anchoring site 1900. For example, the anchoring site 1900 can be tissue of the patient. FIG. 19 illustrates the tissue of the anchoring site 1900 pulled into the clip 1800 (e.g., when the retractor 1804 is retracted relative to the engagement surface 1802). The tissue of the anchoring site 1900 contacts the engagement surface 1802 when the tissue is drawn into the clip 1800. When the tissue contacts the engagement surface 1802, the protrusions of the engagement surface 1802 catch the tissue and maintain engagement with the tissue. A greater surface area of tissue contacting the engagement surface 1802 creates a stronger engagement between the clip 1800 and the anchoring site 1900. In some implementations, the clip 1800 can be closed and / or crimped (e.g., during the retraction of the retractor 1804). For example, the engagement surface 1802 may beAtorney Docket No. 07039-2362WO1 / 2023-018 closed and / or crimped to pinch and / or crimp the tissue of the anchoring site between multiple engagement surfaces 1802.

[0159] FIG. 20 illustrates another example of a clip 2000 for attaching a prosthetic flap valve system to the gastroesophageal junction. The clip 2000 is another example of an anchor member that can be used as described herein. The prosthetic flap valve system can be similar to the prosthetic flap valve system 1500 of FIG. 15 or any of the other devices and systems described herein. The clip 2000 includes an engagement surface 2002 configured to engage the anchoring site of the gastroesophageal junction. The engagement surface 2002 can include, e.g., protrusions configured to catch the tissue and maintain engagement with the tissue. The anchoring site of the gastroesophageal junction is illustrated with reference to FIG. 21. The clip 2000 also includes a retractor 2004 configured to be retracted relative to the engagement surface 2002. In the illustrated embodiment, the retractor 2004 includes a spring, but in other embodiments may or may not include a spring. When the retractor 2004 is retracted relative to the engagement surface 2002, the tissue of the anchoring site is drawn into the clip 2000, and a greater surface area of tissue contacts the engagement surface 2002. Also, the retractor 2004 can include a rotating lock shaft 2006 that allows the retractor to rotate relative to the engagement surface 2002. The lock shaft 2006 can be rotated from a locked position, in which the retractor 2004 is locked axially relative to the engagement surface 2002, to an unlocked position, in which the retractor 2004 is moveable axially relative to the engagement surface 2002.

[0160] The clip 2000 can be positioned at the anchoring site of the gastroesophageal junction using an instrument (e.g., an endoscope). FIG. 21, illustrates the anchoring site 2100. The anchoring site 2100 can be tissue of the patient. FIG. 21 illustrates the tissue pulled into the clip 2000 (e.g., when the retractor 2004 is retracted relative to the engagement surface 2002). The tissue of the anchoring site 2100 contacts the engagement surface 2002 when the tissue is drawn into the clip 2000. When the tissue contacts the engagement surface 2002, the protrusions of the engagement surface 2002 catch the tissue and maintain engagement with the tissue. A greater surface area of tissue contacting the engagement surface 2002 creates a stronger engagement between the clip 2000 and the anchoring site 2100. The retractor 2004 can be rotated relative to the engagement surface 2002 (e.g., as illustrated by arrow 2102) to lock or unlock the lock shaft 2006. In some implementations, the clip 2000 can be closed and / or crimped (e.g., during the retractionAtorney Docket No. 07039-2362WO1 / 2023-018 of the retractor 2004). For example, the engagement surface 2002 may be closed and / or crimped to pinch and / or crimp the tissue of the anchoring site between multiple engagement surfaces 2002. The clip 2000 is also releasable from the anchoring site 2100. For example, the retractor 2004 can be rotated to unlock the lock shaft 2006, such that the retractor 2004 can be moved axially relative to the engagement surface 2002. and the engagement surface 2002 can be uncrimped and / or opened to release the tissue of the anchoring site 2100.

[0161] FIG. 22 depicts an example clip 2200 with wires 2202 configured to be attached to a prosthetic flap valve (illustrated in FIGS. 23 and 24) to form a prosthetic flap valve system. For example, the prosthetic valve system can be similar to the prosthetic valve system 1500 of FIG. 15. In some embodiments, the clip 2200 can be similar to the clip 1800 of FIG. 18. In some embodiments, the clip 2200 can be similar to the clip 2000 of FIG. 20. The wires 2202 can be composed of nitinol or another biocompatible material. The wires 2202 can be attached to the clip 2200. For example, the wires 2202 can be woven into the clip 2200, integrated with the clip 2200, or otherwise attached to the clip 2200.

[0162] FIG. 23 depicts the clip 2200 with wires 2202 and a prosthetic flap valve 2204. The prosthetic flap valve 2204 includes wires 2206 that can be attached to the wires 2202 of the clip 2200 (as illustrated in FIG. 24). The wires 2206 can be attached to the prosthetic flap valve 2204. For example, the wires 2206 can be woven into the prosthetic flap valve 2204, integrated with the prosthetic flap valve 2204, or otherwise attached to the prosthetic flap valve 2204. In one embodiment, the wires 2206 can be woven into the prosthetic flap valve 2204 and then overmolded, e.g., in silicone.

[0163] FIG. 24 depicts clip 2200 with the wires 2202 of the clip 2200 attached to the wires 2206 of the prosthetic flap valve 2204. For example, the wires 2206 can be sown together or otherwise attached. In some embodiments, the wires 2202 can provide a hinge for the prosthetic flap valve 2204 to move relative to the clip 2200. In some embodiments, the woven connection of the wires 2202 and the clip 2200 provides a torque on the prosthetic flap valve system.

[0164] FIG. 25 depicts the prosthetic flap valve system of FIG. 24 installed on the endoscope 1700 of FIG. 17 for an endoscopic delivery’ into the gastroesophageal junction. The prosthetic flap valve 2204 is wrapped around the endoscope 1700. For example, the prosthetic flap valve 2204 can be installed on the endoscope 1700 in a similar fashion asAtorney Docket No. 07039-2362WO1 / 2023-018 the prosthetic flap valve system 1500 of FIG. 15 is installed on the endoscope 1502 of FIG. 15. A band 2500 surrounds the prosthetic flap valve 2204 and restrains the prosthetic flap valve 2204 relative to the endoscope 1700. For example, the band 2500 prevents the prosthetic flap valve 2204 from opening into a deployed position (e.g., as illustrated in FIG. 29).

[0165] A release wire 2502 is attached to the band 2500. The release wire 2502 is configured to release the band 2500 from the prosthetic valve 2204 to allow the prosthetic valve 2204 to open into the deployed position (e.g., as illustrated in FIG. 29). For example, the release wire 2502 can be pulled in the proximal direction, illustrated by arrow 2504, to move the band 2500 axially relative to the prosthetic valve 2204 and release the prosthetic valve 2204 after the prosthetic valve system 2204 is attached to the anchoring site (e.g., as described relative to FIGS. 18 and 19).

[0166] FIG. 26 depicts a side view of an example prosthetic flap valve system 2600. The prosthetic flap valve system can be similar to the prosthetic flap valve system of FIG. 24. The prosthetic flap valve system includes a prosthetic flap valve 2602 that is connected to an anchoring element 2604 via a hinge, such that the prosthetic flap valve 2602 can open and close around a pivot point.

[0167] FIG. 27 depicts a side view of another example prosthetic flap valve system 2700. The prosthetic flap valve system can be similar to the prosthetic flap valve system of FIG.

[0168] 24. The prosthetic flap valve system includes a prosthetic flap valve 2702 that is connected to an anchoring element 2704 via a hinge, such that the prosthetic flap valve 2702 can open and close around a pivot point. The prosthetic flap valve system 2700 also includes a wire 2706 that can provide additional torque to the prosthetic flap valve system 2700 when the prosthetic flap valve system 2700 is placed into the gastrointestinal tract. For example, the wire 2706 can extend into the esophagus, and the additional torque provided by the wire 2706 can help position the prosthetic flap valve system 2700 in the correct placement relative to the gastroesophageal junction.

[0169] FIG. 28 depicts an example prosthetic flap valve system 2800 inside a stomach and gastroesophageal junction. The view of FIG. 28 is show n from the perspective of the interior of the stomach. For example, an endoscope 2850 is illustrated extending into the stomach and taking a picture of the prosthetic flap valve system 2800 from the interior of the stomach. The prosthetic flap valve system 2800 can be similar to the prosthetic flap valve system of FIG. 24 and / or the prosthetic flap valve system of FIGS. 10 and 11.Atorney Docket No. 07039-2362WO1 / 2023-018 During a swallowing operation, food or liquid can apply enough pressure to the prosthetic hinge of the prosthetic flap valve system 2800 that the hinge facilitates the prosthetic flap valve 2802 to open in the direction away from the lesser curvature and the food or liquid will pass into the stomach. The hinge operation opens and closes around a pivot point that allows rotational movement between prosthetic flap valve 2802 and the anchor member. The hinge enables the prosthetic flap valve 2802 to open and close around the pivot point. In this case, the hinge is designed to bias the prosthetic flap valve 2802 to a closed position. In some embodiments, a prosthetic flap valve 2802 is secured in the closed position by way of an additional anchor member.

[0170] FIG. 29 depicts the example prosthetic flap valve system of FIG. 28 inside an esophagus and the gastroesophageal junction. The view of FIG. 29 is show n from the perspective of the interior of the esophagus. For example, an endoscope 2850 is illustrated extending into the esophagus and taking a picture of the prosthetic flap valve system 2800 from the interior of the esophagus.

[0171] FIG. 30 depicts a side view' of an example prosthetic flap valve system 3000. The prosthetic flap valve system 3000 can be similar to the prosthetic flap valve system 2800 of FIG. 28. The prosthetic flap valve system 3000 includes an anchoring element 3002 and a prosthetic flap 3004. The prosthetic flap 3004 can extend perpendicularly from the anchoring element 3002. For example, in the illustration of FIG. 30, the prosthetic flap 3004 extends linearly to the left.

[0172] FIG. 31 depicts a side view' of another example prosthetic flap valve system 3100. The prosthetic flap valve system 3100 can be similar to the prosthetic flap valve system 2800 of FIG. 28. The prosthetic flap valve system 3100 includes an anchoring element 3102 and a prosthetic flap 3106. The prosthetic flap 3106 can extend at an angle from the anchoring element 3102. For example, in the illustration of FIG. 31, the prosthetic flap 3106 is overlay ed over a prosthetic flap 3104 that extends linearly and perpendicularly from the anchoring element 3102 (e.g., the prosthetic flap 3104 is similar to the prosthetic flap 3004). The prosthetic flap 3106 curves and extends upwards relative to prosthetic flap 3104. The prosthetic flap 3106 is illustrated to show' that prosthetic flaps can extend in a variety of directions relative to the anchoring element 3102. For example, in some embodiments, the prosthetic flap can extend at an angle downwards relative to the prosthetic flap 3104. In some embodiments, the prosthetic flap can extend at a lesser angle or a greater angle.Atorney Docket No. 07039-2362WO1 / 2023-018 FIG. 32 depicts a top view of an example prosthetic flap valve system 3200. The prosthetic flap valve system 3200 can be similar to the prosthetic flap valve system 2800 of FIG. 28. The prosthetic flap valve system 3200 includes an anchoring element 3202 and a prosthetic flap 3204.

[0173] FIG. 33 depicts atop view of another example prosthetic flap valve system 3300 overlayed with the example prosthetic flap valve system 3200 of FIG. 32. The prosthetic flap valve system 3300 can be similar to the prosthetic flap valve system 2800 of FIG. 28. The prosthetic flap valve system 3300 includes an anchoring element 3302 and a prosthetic flap 3304. The prosthetic flap 3304 has a different shape than the prosthetic flap 3204. For example, in some embodiments, the prosthetic flap 3304 is wider than the prosthetic flap 3302. The prosthetic flap 3304 is illustrated to show that prosthetic flaps can have a variety7of dimensions. For example, in some embodiments, the prosthetic flap can be wider, longer, thinner, shorter, etc. The prosthetic flap valve system 3300 also includes two stabilizer wires 3306 that can provide stability to the prosthetic flap. For example, the stabilizer wires 3306 can be stiffer than the material of the prosthetic flap 3304. The stabilizer wires 3306 can help the prosthetic flap 3304 maintain a desired shape when the prosthetic flap 3304 is in the deployed position. In some embodiments, the prosthetic flap valve system can include more or fewer stabilizer wires. The stabilizer wires can also have different shapes and stiffnesses to provide the prosthetic flap with a desired stiffness and shape.

[0174] In some embodiments, the methods can include laparoscopically implanting one or more elongation members (e.g.. any of the elongating members described herein) and one or more anchor members (e.g., any of the anchor members described herein) to the gastric wall and flap valve of the subject. In some embodiments, implanting one or more elongation members and one or more anchor members is based in part on the severity7of the GERD and / or hiatal hernia.

[0175] In some embodiments, the methods can include a combination of endoscopic laparoscopic techniques of implanting one or more elongation members (e.g., any of the elongating members described herein) and one or more anchor members (e.g., any of the anchor members described herein) to the gastric wall and flap valve of the subj ect. In some embodiments, implanting one or more elongation members and one or more anchor members is based in part on the severity of the GERD and / or hiatal hernia.Atorney Docket No. 07039-2362WO1 / 2023-018 In some embodiments, the methods can include endoscopically implanting one or more prosthetic flap valve systems (e.g., any of the prosthetic flap valve systems described herein) to the GEJ of the subject. In some embodiments, implanting one or more elongation members and one or more anchor members is based in part on the severity of the GERD and / or hiatal hernia.

[0176] In some embodiments, the methods can include laparoscopically implanting one or more prosthetic flap valve systems (e.g., any of the prosthetic flap valve systems described herein) to the GEJ of the subject. In some embodiments, implanting one or more elongation members and one or more anchor members is based in part on the severity of the GERD and / or hiatal hernia.

[0177] In some embodiments, the methods can include a combination of endoscopic laparoscopic techniques of implanting one or more one or more prosthetic flap valve systems (e.g., any of the prosthetic flap valve systems described herein) to the GEJ of the subject. In some embodiments, implanting one or more elongation members and one or more anchor members is based in part on the severity of the GERD and / or hiatal hernia.

[0178] FIG. 34 depicts an example method 3400 for implanting a prosthetic flap valve system into a subject. The method 3400 includes, (3402) positioning a prosthetic flap valve system on an endoscope or laparoscope. For example, the components of any one of the prosthetic flap valve systems disclosed herein can be sized to fit into an endoscope or a laparoscope or both. For example, any one of the prosthetic flap valve systems disclosed herein can be loaded to an endoscope or a laparoscope or both such that the implanting is performed via endoscopically, laparoscopically, or both. For example, the prosthetic flap valve system can be similar to the prosthetic flap valve systems described herein (e.g., the prosthetic flap valve systems of FIGS. 10, 11, 15, 16, and 22-33). The prosthetic flap valve can be wrapped around the endoscope or laparoscope. For example, the prosthetic flap valve can be installed on the endoscope or laparoscope in a similar fashion as the prosthetic flap valve system 1500 is installed on the endoscope 1502 in FIG. 15. The prosthetic flap valve can be installed on the endoscope or laparascope in a similar fashion as the prosthetic flap valve system 2204 is installed on the endoscope 1700 in FIG. 25. For example, a band could surround the prosthetic flap valve and restrain the prosthetic flap valve relative to the endoscope.Atorney Docket No. 07039-2362WO1 / 2023-018 In some embodiments, a single channel endoscope is utilized. In other embodiments, a multiple channel endoscope is utilized. In some embodiments, an endoscopic robotic system is used.

[0179] The method 3400 can further include, (3404) advancing the prosthetic flap valve system to an anchoring site. The anchoring site can include a desired portion of the gastrointestinal tract. The anchoring site can be the gastroesophageal junction of the subject. Advancing the prosthetic flap valve system can include the oral insertion of an endoscope under sedation or anesthesia of the subject. The endoscope can provide realtime visualization of the implant, which can be loaded onto a dedicated delivery system. The implant is navigated through a working channel of the endoscope to access the targeted site within the GEJ tract or could be deliver over or adjacent the endoscope.

[0180] The method 3400 can further include, (3406) anchoring the prosthetic flap valve system at the anchoring site. For example, anchoring the prosthetic flap valve system can include anchoring an anchoring element, such as clip, suture, plication, or stent to bolster or anchor the prosthetic flap valve system. The anchoring element can include a clip similar to those described with relation to FIGS. 18-21. The anchoring site includes tissue. The tissue pulled into the clip (e.g., when the retractor of the clip is retracted relative to the engagement surface of the clip). The tissue of the anchoring site contacts the engagement surface when the tissue is drawn into the clip. When the tissue contacts the engagement surface, the protrusions of the engagement surface catch the tissue and maintain engagement with the tissue. A greater surface area of tissue contacting the engagement surface creates a stronger engagement between the clip and the anchoring site. In some embodiments, the retractor can be rotated relative to the engagement surface (e.g., as illustrated by arrow) to lock or unlock the lock shaft. In some implementations, the clip can be closed and / or crimped (e.g., during the retraction of the retractor). For example, the engagement surface may be closed and / or crimped to pinch and / or crimp the tissue of the anchoring site between multiple engagement surfaces. The clip can also be releasable from the anchoring site. For example, the retractor can be rotated to unlock the lock shaft 2006, such that the retractor can be moved axially relative to the engagement surface, and the engagement surface can be uncrimped and / or opened to release the tissue of the anchoring site.

[0181] The method can further include, (3408) deploying the prosthetic flap valve system. For example, deploying the prosthetic flap valve system can include releasing theAtorney Docket No. 07039-2362WO1 / 2023-018 prosthetic flap valve system from the endoscope or laparoscope. The prosthetic flap valve system can open into a deployed position (e.g., as illustrated in FIG. 29). In some embodiments, the prosthetic flap valve system is attached to the endoscope or laparoscope by a band that restrains the prosthetic flap valve system, as described herein. In some embodiments, a release wire is attached to the band. Deploying the prosthetic flap valve system can include releasing the band from the prosthetic valve to allow the prosthetic valve to open into the deployed position. For example, the release wire can be pulled in the proximal direction to move the band axially relative to the prosthetic valve and release the prosthetic valve after the prosthetic valve system is attached to the anchoring site.

[0182] FIG. 35 illustrates a robotic system 3500 that can be used for endoscopic, laparoscopic, a hybrid delivery, or other surgical deliveries of a prosthetic valve system. For example, the robotic system 3500 can be used to deliver any of the prosthetic valve systems described herein. In some implementations, the robotic system 3500 can enter a patient via the mouth and be advanced through the esophagus to the stomach. In some implementations, the robotic system 3500 can enter the patient via the skin and an incision through the stomach wall. The robotic system 3500 can enter the lower stomach, aiming upwards at the junction to deliver the prosthetic valve system in the desired location. The robotic system 3500 includes a drive 3502 that can advance the robotic system through the patient. The robotic system 3500 also includes a camera 3504 to provide a video feed of the surgery. The robotic system 3500 includes articulating arms 3506 which can grab the prosthetic valve system and position the prosthetic valve system as desired. In some implementations, the robotic system 3500 can include more or fewer articulating arms 3506 (e.g., one arm, three arms, four arms, etc.).

[0183] OTHER EMBODIMENTS

[0184] It is to be understood that while the invention has been described in conjunction with the detailed description thereof, the foregoing description is intended to illustrate and not limit the scope of the invention, which is defined by the scope of the appended claims. Other aspects, advantages, and modifications are within the scope of the following claims.

Claims

Atorney Docket No. 07039-2362WO1 / 2023-018 WHAT IS CLAIMED IS:

1. A method of deploying a prosthetic flap valve system within a patient, the method comprising:positioning the prosthetic flap valve system on an endoscope or laparoscope; advancing the endoscope or laparoscope with the prosthetic flap valve system to an anchoring site at the gastroesophageal junction (GEJ) of the patient;anchoring the prosthetic flap valve system to tissue of the patient at the anchoring site; anddeploying the prosthetic flap valve system.

2. The method of claim 1. wherein positioning the prosthetic flap valve system on the endoscope or laparoscope comprises wrapping the prosthetic flap valve system around a distal end of the endoscope or laparoscope.

3. The method of claim 1 or claim 2, wherein anchoring the prosthetic flap valve system at the anchoring site comprises anchoring one or more of a magnet, a helical structure fastener, a clip structure, a tissue anchor, a needle pin, an anchoring ring, a screw, a suture, a plication basket, or a staple at the anchoring site.

4. The method of claim 3, wherein anchoring the prosthetic valve comprises anchoring a clip structure, comprising retracting a portion of the clip structure to cause an engagement surface to engage the tissue of the patient.

5. The method of claim 4, wherein anchoring the clip structure further comprises rotating a lock shaft of the clip structure to lock the portion of the clip structure.

6. The method of any one of claims 4-5, wherein anchoring the clip structure comprises crimping the engagement surface of the clip structure.

7. The method of any one of claims 1-6, wherein deploying the prosthetic valve flap system comprises allowing the prosthetic valve flap system to open.Atorney Docket No. 07039-2362WO1 / 2023-018 8. The method of any one of claims 1-7, wherein deploying the prosthetic valve flap system comprises removing a restraining band from the prosthetic valve flap system.

9. The method of claim 8, wherein deploying the prosthetic valve flap system comprises moving a release wire axially to remove the restraining band from the prosthetic valve flap system.

10. The method of any one of claims 1-9, wherein the prosthetic flap valve system comprises an elongation member having a first end and a second end. a first anchor member coupled to the first end of the elongation member and configured to couple the first end of the elongation member to the gastric wall of the GEJ of the patient, a second anchor member coupled to the second end of the elongation member and configured to couple the second end of the elongation member to a flap valve, wherein the elongation member is configured to bias the flap valve to a closed position, and wherein the closed position of the flap valve provides a separation between the esophagus and the stomach.

11. The method of claim 10, wherein the elongation member is one of a compression spring, an extension spring, a torsion spring, or an elastic band.

12. The method of claim 10 or claim 11, wherein the first and second anchor members are one or more of a magnet, a helical structure fastener, a clip structure, a tissue anchor, a needle pin, an anchoring ring, a screw, a suture, a plication basket, or a staple.

13. The method of any one of claims 10-12, wherein the flap valve is a non-prosthetic flap valve.

14. The method of any one of claims 10-13, wherein the first anchor member is configured to couple the first end of the elongation member to the gastric wall portion is toward the lesser curvature of the stomach such that the elongation member is contracted when the flap valve is biased in an open position.Atorney Docket No. 07039-2362WO1 / 2023-018 15. The method of any one of claims 10-13, wherein the first anchor member is configured to couple the first end of the elongation member to the gastric wall portion is toward the greater curvature of the stomach such that the elongation member is compressed when the flap valve is biased in an open position.

16. The method of any one of claims 1-9, wherein the prosthetic flap valve system comprises a prosthetic flap valve having a first end, a second end, and a border that demarcates an interface between the prosthetic flap valve and tissue of a subject, a gasket coupled to the border and the interface between the prosthetic flap valve and tissue of a subject, one or more anchor members coupled to the first end of the prosthetic flap valve and configured to anchor the prosthetic flap to tissue of the subject, a second end of the prosthetic flap valve opposite the first end, wherein the second end of the prosthetic flap valve is configured to bias to a closed position toward the lesser curvature of the stomach, and wherein the closed position of the prosthetic flap valve provides a separation between the esophagus and the stomach of the subject.

17. The method of claim 16, wherein the gasket is configured to interface the prosthetic flap valve to tissue of the subject when biased in the closed position.

18. The method of claim 1 , wherein the gasket is made from a silicone material.

19. The method of any one of claims 16-18, wherein the one or more anchor members are one or more of a magnet, a helical structure fastener, a clip structure, a tissue anchor, a needle pin, a screw, a suture, a plication basket, or a staple.

20. The method of any one of claims 16-19, wherein the prosthetic flap valve system further comprises one or more magnets coupled to the second end of the prosthetic valve, wherein the one or more magnets are configured to secure the second side of the prosthetic flap valve to the tissue of the subject when the prosthetic flap valve is biased in the closed position.

21. A method of implanting a prosthetic flap valve system within a patient, the method comprising:Atorney Docket No. 07039-2362WO1 / 2023-018 identifying a subject as having GERD and / or a hiatal hernia;determining a treatment based on a severity of the GERD, the presence or absence of a native flap valve, and / or hiatal hernia;selecting the prosthetic flap valve system based on the determined treatment; positioning the prosthetic flap valve system on an endoscope or laparoscope; advancing the endoscope or laparoscope with the prosthetic flap valve system to an anchoring site at the gastroesophageal junction (GEJ) of the patient;anchoring the prosthetic flap valve system to tissue of the patient at the anchoring site; anddeploying the prosthetic flap valve system.

22. The method of claim 21, wherein positioning the prosthetic flap valve system on the endoscope or laparoscope comprises wrapping the prosthetic flap valve system around a distal end of the endoscope or laparoscope.

23. The method of claim 21 or claim 22, wherein anchoring the prosthetic flap valve system at the anchoring site comprises anchoring a clip at the anchoring site.

24. The method of claim 23, wherein anchoring the clip comprises retracting a portion of the clip to cause an engagement surface to engage the tissue of the patient.

25. The method of claim 24, wherein anchoring the clip further comprises rotating a lock shaft of the clip to lock the portion of the clip.

26. The method of any one of claims 23-25, wherein anchoring the clip comprises crimping the engagement surface of the clip.

27. The method of any one of claims 21-26, wherein deploying the prosthetic valve flap system comprises allowing the prosthetic valve flap system to open.

28. The method of any one of claims 21-27, wherein deploying the prosthetic valve flap system comprises removing a restraining band from the prosthetic valve flap system.Atorney Docket No. 07039-2362WO1 / 2023-018 29. The method of claim 28, wherein deploying the prosthetic valve flap system comprises moving a release wire axially to remove the restraining band from the prosthetic valve flap sy stem.

30. The method of any one of claims 21-29, wherein the prosthetic flap valve system comprises an elongation member having a first end and a second end, a first anchor member coupled to the first end of the elongation member and configured to couple the first end of the elongation member to the gastric wall of the GEJ of the patient, a second anchor member coupled to the second end of the elongation member and configured to couple the second end of the elongation member to a flap valve, wherein the elongation member is configured to bias the flap valve to a closed position, and wherein the closed position of the flap valve provides a separation between the esophagus and the stomach.

31. The method of claim 30, wherein the elongation member is one of a compression spring, an extension spring, a torsion spring, or an elastic band.

32. The method of claim 30 or claim 31, wherein the first and second anchor members are one or more of a magnet, a helical structure fastener, a clip structure, a tissue anchor, a needle pin, an anchoring ring, a screw, a suture, a plication basket, or a staple.

33. The method of any one of claims 30-32, wherein the flap valve is a non-prosthetic flap valve.

34. The method of any one of claims 30-33, wherein the first anchor member is configured to couple the first end of the elongation member to the gastric wall portion is toward the lesser curvature of the stomach such that the elongation member is contracted when the flap valve is biased in an open position.

35. The method of any one of claims 30-33, wherein the first anchor member is configured to couple the first end of the elongation member to the gastric wall portion is toward the greater curvature of the stomach such that the elongation member is compressed when the flap valve is biased in an open position.Atorney Docket No. 07039-2362WO1 / 2023-018 36. The method of any one of claims 21-29, wherein the prosthetic flap valve system comprises a prosthetic flap valve having a first end, a second end, and a border that demarcates an interface between the prosthetic flap valve and tissue of a subject, a gasket coupled to the border and the interface between the prosthetic flap valve and tissue of a subject, one or more anchor members coupled to the first end of the prosthetic flap valve and configured to anchor the prosthetic flap to tissue of the subject, a second end of the prosthetic flap valve opposite the first end, wherein the second end of the prosthetic flap valve is configured to bias to a closed position toward the lesser curvature of the stomach, and wherein the closed position of the prosthetic flap valve provides a separation between the esophagus and the stomach of the subject.

37. The method of claim 36, wherein the gasket is configured to interface the prosthetic flap valve to tissue of the subject when biased in the closed position.

38. The method of claim 36, wherein the gasket is made from a silicone material.

39. The method of any one of claims 36-38, wherein the one or more anchor members are one or more of a magnet, a helical structure fastener, a clip structure, a tissue anchor, a needle pin, a screw, a suture, a plication basket, or a staple.

40. The method of any one of claims 36-39, wherein the prosthetic flap valve system further comprises one or more magnets coupled to the second end of the prosthetic valve, w herein the one or more magnets are configured to secure the second side of the prosthetic flap valve to the tissue of the subject when the prosthetic flap valve is biased in the closed position.

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