Devices and methods for creating or augmenting gastric flap valves

Abstract

This document provides devices and methods for prosthetic flap valve system, comprising 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 a subject, 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 the closed position of the flap valve provides a separation between the esophagus and the stomach.

Description

[0001] DEVICES AND METHODS FOR CREATING OR AUGMENTING GASTRIC FLAP VALVES

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Application Serial No. 63 / 535,434, filed August 30, 2023. 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.

[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 junction 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. 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.

[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 relief 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.

[0017] 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.

[0018] One aspect of this document features devices and methods for creating or augmenting a gastric flap valve. In some example embodiments, devices can include, or consist essentially of, a prosthetic flap valve system, including 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 a subject, 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, where the elongation member is configured to bias the flap valve to a closed position, and the closed position of the flap valve provides a separation between the esophagus and the stomach.

[0019] In some embodiments, the elongation member is one of a compression spring, an extension spring, a torsion spring, or an elastic band. 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. In some embodiments, the flap valve is a non-prosthetic flap valve. 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. 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. In some embodiments, the elongation member, the first anchor member, and the second anchor member are configured to be implanted within the subject endoscopically, laparoscopically, or both.

[0020] In other example embodiments, devices can include, or consist essentially of, a prosthetic flap valve system, comprising 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, where the second end of the prosthetic flap valve is configured to bias to a closed position toward the lesser curvature of the stomach, and the closed position of the prosthetic flap valve provides a separation between the esophagus and the stomach of the subject. In some embodiments, devices can include, or consist essentially of, the gasket is configured to interface the prosthetic flap valve to tissue of the subject when biased in the closed position. In some embodiments, the gasket is made from a silicone material. 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. In some embodiments, one or more magnets coupled to the second end of the prosthetic valve, where 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. In some embodiments, the prosthetic flap valve is made from one or more materials selected from polymer, silicone, hydrogel, collagen-based material, a composite material, or biological materials. In some embodiments, the one or more anchor members are aligned within a frame on the first end of the prosthetic valve. In some embodiments, the frame is configured to secure the first end of the prosthetic flap valve to the gastric wall adjacent to the greater curvature of the stomach. In some embodiments, devices can include a membrane positioned within the prosthetic flap valve, where the frame is configured to secure the membrane taunt such that is covers the opening to the esophagus. In some embodiments, a portion of the membrane that is proximate to the second end of the prosthetic flap valve provides an opening between the prosthetic flap valve and the gastric wall toward the lesser curvature of the stomach. In some embodiments, the membrane is made from one or more flexible materials selected from silicone, hydrogel, biocompatible fabric, or biocompatible polymer. In some embodiments, the prosthetic flap valve and the one or more anchor members are configured to be implanted within the subject endoscopically, laparoscopically, or both.

[0021] In some embodiments, methods can include, or consist essentially of, method for implanting a prosthetic flap valve system into a subject, including identifying a subject has having GERD and / or hiatal hernia, determining a treatment based on a severity of the GERD, the presence or absence of native flap valve, and / or hiatal hernia size, and implanting any one of the prosthetic flap valve systems of disclosed herein in the gastroesophageal junction of the subject, where the implanting is performed via endoscopically, laparoscopically, or both.

[0022] In other example embodiments, devices can include, or consist essentially of, a prosthetic flap valve system, comprising a prosthetic flap valve system, comprising a prosthetic flap valve having a first end and a second end, a first anchor member coupled to the first end of the prosthetic flap valve and configured to couple the first end of the prosthetic flap valve to a portion of a native flap valve of a subject, a second anchor member coupled to the second end of the prosthetic flap valve and configured to couple the second end of the prosthetic flap valve to a different portion of the native flap valve, where the prosthetic flap valve is configured to bias the flap valve to a closed position, and the closed position of the flap valve provides a separation between the esophagus and the stomach.

[0023] In some embodiments, the prosthetic flap valve comprises a silicon-base or other polymer or biologic outer structure with an inner core composed of metal. In some embodiments, the metal is one or more of nitinol, memory wire, a synthetic or biologic mesh skeleton with the capability to alter the shape and / or direction of the prosthetic flap valve to either permit the passage of food or prevent gastroesophageal reflux. In some embodiments, the silicon-base outer structure has a variable thickness configured to adapt to fit at the gastroesophageal junction. In some embodiments, the prosthetic flap valve is sized in one or more of an oval, a rectangle, a cone, or a roll-out. In some embodiments, the prosthetic flap valve further comprises a mesh component, wherein the mesh component of the clip allows for tissue ingrowth at the gastroesophageal junction, promoting long-term integration and anchoring of the valve. In some embodiments, the mesh component comprises one or more recesses comprising magnets. In some embodiments, the first anchor member and the second anchor member comprise hooks or barbs configured to secure the prosthetic flap valve to the native flap valve. In some embodiments, the first anchor member and the second anchor member are bent and configured to secure the prosthetic flap valve to the native flap valve.

[0024] 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. 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.

[0025] DESCRIPTION OF THE DRAWINGS

[0026] FIG. 1 depicts a cross-section schematic of an esophageal and stomach system, gastric flap valve, and endoscope.

[0027] FIG. 2 depicts a schematic of various layers of the esophageal and stomach system of

[0028] FIG. 1

[0029] 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.

[0030] 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.

[0031] FIG. 5 depicts an endoscopic ultrasound image of a stomach and gastroesophageal junction of a subject.

[0032] FIG. 6 depicts a cross-section view of an example elongation member inside the stomach and lower gastroesophageal junction.

[0033] FIG. 7 depicts a perspective view of the example elongation member of FIG. 6 inside the stomach and gastroesophageal junction.

[0034] FIG. 8 depicts a cross-section view of another example elongation member inside the stomach and gastroesophageal junction.

[0035] FIG. 9 depicts a perspective view of the example elongation member of FIG. 8 inside the stomach and gastroesophageal junction.

[0036] FIG. 10 depicts a cross-section view of an example prosthetic flap valve system inside a stomach and gastroesophageal junction.

[0037] FIG. 11 depicts a perspective view of the example prosthetic flap valve system of FIG. 10 inside a stomach and gastroesophageal junction.

[0038] FIG. 12 depicts a cross-section view of another example prosthetic flap valve system inside a stomach and gastroesophageal junction. FIG. 13 depicts a perspective view of the example prosthetic flap valve of FIG. 12 inside a stomach and gastroesophageal junction.

[0039] FIG. 14 depicts a cross-section schematic of an endoscopic ultrasound delivering a flap-valve augmentation prosthetic elements to the gastroesophageal junction.

[0040] FIG. 15 depicts an example method for implanting a prosthetic flap valve system into a subject.

[0041] FIG. 16A depicts an example prosthetic flap valve system with an anchor member in an open position.

[0042] FIG. 16B depicts the example prosthetic flap valve system of FIG. 16A with the anchor member in a closed position and attached to a native tissue flap valve.

[0043] FIG. 16C depicts a side view of the example prosthetic flap valve system of FIG. 16B with the anchor member attached to a native tissue flap valve.

[0044] FIG. 17A depicts another example of a prosthetic flap valve system with magnetic anchor members.

[0045] FIG. 17B depicts a side view of the example prosthetic flap valve system of FIG. 17A with the magnetic anchor member.

[0046] FIG. 18A depicts another example of a prosthetic flap valve system with magnetic anchor members and a separate prosthetic flap valve.

[0047] FIG. 18B depicts a side view of the example prosthetic flap valve system of FIG. 18A with the magnetic anchor members and separate prosthetic flap valve.

[0048] FIG. 19A depicts a side view of an example prosthetic flap valve system with an anchor member in an undeployed position.

[0049] FIG. 19B depicts a side view of the example prosthetic flap valve system of FIG. 19A with the anchor member in a deployed position and attached to a native tissue flap valve.

[0050] FIG. 19C depicts the example prosthetic flap valve system of FIG. 19B with the anchor member deployed attached to a native tissue flap valve.

[0051] FIG. 20A depicts an example of a prosthetic flap valve system that includes a bioabsorbable anchor member connected to a silicone body of the prosthetic flap valve.

[0052] FIG. 20B is a side view of the example prosthetic flap valve system of FIG. 20Athat includes a bioabsorbable anchor member connected to a silicone body of the prosthetic flap valve. FIG. 20C is another side view of the example prosthetic flap valve system of FIG. 20Athat includes a bioabsorbable anchor member connected to a silicone body of the prosthetic flap valve and an implant tool.

[0053] FIG. 21 A depicts an example of a prosthetic flap valve system that includes a bent clip anchor member connected to a silicone body of the prosthetic flap valve.

[0054] FIG. 21B is a side view of the example prosthetic flap valve system of FIG. 21 A that includes a bent clip anchor member connected to a silicone body of the prosthetic flap valve.

[0055] FIG. 21C is another side view of the example prosthetic flap valve system of FIG. 21 A that includes a bent clip anchor member connected to a silicone body of the prosthetic flap valve and an implant tool.

[0056] FIG. 22A depicts an example of a prosthetic flap valve system that includes a bent clip anchor member connected to a silicone body of the prosthetic flap valve.

[0057] FIG. 22B is the example prosthetic flap valve system of FIG. 22Athat includes a clip anchor member connected to a native flap valve and a prosthetic flap valve.

[0058] FIG. 23 A depicts an example of a prosthetic flap valve system that includes a gastric stent and a clip anchor member.

[0059] FIG. 23B depicts an example of a prosthetic flap valve system of FIG. 23 A that includes a gastric stent and a clip anchor member coupled to a native flap valve.

[0060] DETAILED DESCRIPTION

[0061] 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.

[0062] 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.

[0063] 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.

[0064] 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 236 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.

[0065] 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.

[0066] 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 occurs 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.

[0067] 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 His 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. 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 weakened support prevent effective closure, leads to increased potential for reflux even during normal swallowing.

[0068] 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. Non-limiting shapes for the elongation member or prosthetic flap valve can include oval, rectangular, circular, cone-like, wingshaped, or roll-out designs to suit varying anatomical and functional requirements. In some embodiments, prosthetic flap valve are variable and personalized to a particular subjects’ anatomy depending on the size of the gastroesophageal junction opening and / or hiatal hernia size. In such embodiments, a prosthetic flap valve can take different shapes such as oval, circular, rectangular, wing shaped. In some embodiments, the diameter can range between 1- 8 cm, the length can range between 1-8 cm.

[0069] In an example 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 real-time 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. 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.

[0070] 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.

[0071] 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 instance, in the 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.

[0072] 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.

[0073] 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 real-time 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.

[0074] 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.

[0075] 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.

[0076] 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 open position. Structures discussed in reference to FIG. 4 can include the same features and details as those described in reference to FIGS. 1-3.

[0077] 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.

[0078] 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).

[0079] 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 barrier 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.

[0080] 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.

[0081] 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.

[0082] 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.

[0083] 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.

[0084] 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's esophagus, a condition characterized by the abnormal extension of columnar epithelium into the esophagus.

[0085] 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 anti -reflux 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.

[0086] 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.

[0087] 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. 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.

[0088] 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 (under 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.

[0089] In the example embodiment shown 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.

[0090] 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. 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 wall 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).

[0091] 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 761A' of the elongation member 760A and the flap valve 714. A third anchor member 762B is coupled to a first end 76 IB 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 76 IB' of the second elongation member 760B and the flap valve 714. The 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.

[0092] 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.

[0093] 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. 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.

[0094] 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.

[0095] 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 noncompressed 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 861' 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'. In 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.

[0096] 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. 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).

[0097] 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 96 IB' 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 961C' 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 961D' 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.

[0098] 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. Such interventions can be effective for GERD and hiatal hernia disorders that are mild to moderate in severity.

[0099] 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.

[0100] 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. 10, the prosthetic flap valve system 1007 is positioned in an area that is between the HPZ and Z line.

[0101] Non-limiting shapes for the prosthetic flap valve can include oval, rectangular, circular, cone-like, wing-shaped, or roll-out designs to suit varying anatomical and functional requirements. In some embodiments, prosthetic flap valve are variable and personalized to a particular subjects’ anatomy depending on the size of the gastroesophageal junction opening and / or hiatal hernia size. In such embodiments, a prosthetic flap valve can take different shapes such as oval, circular, rectangular, wing shaped. In some embodiments, the diameter can range between 1-8 cm, the length can range between 1-8 cm.

[0102] 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 flap valve 1015 that opens toward the lesser curvature 1034 when a swallowing operation takes place and closes by way of the hinge 1019.

[0103] 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.

[0104] 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 flexibility and 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.

[0105] 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.

[0106] 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 subject. 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. In some examples, the border 1131 is an irregular border 1131 shape, evoking a clamshell-like form. The border 1131 exhibits a non-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.

[0107] 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 medicalgrade silicone, polyurethane, polymethyl methacrylate, polyethylene, polytetrafluoroethylene, bioabsorbable polymers, hydrogels, collagen-based materials, or elastomers.

[0108] 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 second 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 1121a-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 1121 a-g can engage to secure closure of the prosthetic flap valve 1115.

[0109] The prosthetic flap valve 1115, closing anchor members 1121 a-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.

[0110] 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.

[0111] 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.

[0112] 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.

[0113] 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. 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.

[0114] 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.

[0115] 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 opening 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.

[0116] 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.

[0117] 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.

[0118] 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 comprise 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 identifying a therapeutic treatment.

[0119] 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 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 severity of the GERD and / or hiatal hernia.

[0120] 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 severity of the GERD and / or hiatal hernia.

[0121] 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 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.

[0122] 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.

[0123] 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.

[0124] 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.

[0125] FIG. 15 depicts an example method 1500 for implanting a prosthetic flap valve system into a subject. The method 1500 includes, (1502) identifying a subject has having GERD and / or hiatal hernia. For example, a subject can be diagnosed by a medical care provider as having GERD and / or hiatal hernia.

[0126] The method 1500 can further include, (1504) determining a treatment based on a severity of the GERD and / or hiatal hernia. For example, a severity of the GERD and / or hiatal hernia can be determined, and a treatment can be selected based on that determination. In some cases, a prosthetic flap valve may need to be implanted. In other cases, a prosthetic elongation member can be implanted to the native flap valve of the subject.

[0127] The method 1500 can further include implanting any one of the prosthetic flap valve systems disclosed herein in the gastroesophageal junction of the subject. 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 sized to be customizable based on patient-specific anatomical data to optimize performance and comfort and / or to be loaded to an endoscope or a laparoscope or both such that the implanting is performed via endoscopically, laparoscopically, or both.

[0128] FIG. 16A depicts an example prosthetic flap valve system 1600 with an anchor member 1602 in an open position. The structures discussed in reference to FIG. 16A can include the same features and details as those described in reference to FIGS. 1-15. In the example embodiments depicted by FIG. 16A, the anchor member 1602 comprises a selflocking or self-coupling mechanism where a first end 1604 configured with a specific geometry that allows it to engage or interlock with a second end 1606. For example, the first end 1604 can include tabs or protrusions configured to engage or interlock with corresponding slots or apertures on the second end of the anchor member 1602. The prosthetic flap valve system 1600 can includes a prosthetic flap valve 1608 that can be made from any suitable material. For example, the prosthetic flap valve system 1600 including the prosthetic flap valve 1608 can be made from any biocompatible 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).

[0129] In some embodiments, a portion of the anchor member 1602 made from a mesh or porous surface, which provides an area for tissue ingrowth or material integration when inserted into the tissue of a subject (e.g., the native flap valve 114 of FIG. 1). The mesh 1610 improves the stability and integration of the anchor member 1602 within the surrounding biological tissue.

[0130] In operation, the prosthetic flap valve 1608 can elongate the exiting native tissue flap valve of the subject to improve symptoms of gastric reflux or GERD. For example, the prosthetic flap valve 1608 is configured to bias to a closed position that provides a separation between the esophagus and the stomach. During a swallowing operation the prosthetic flap valve 1608 can move from a closed position to an open position, where the open position moves the prosthetic flap valve 1608 from a position towards the lesser curvature (e.g., 134 of FIG. 1) toward the greater curvature 232 of FIG. 2) such that food or liquid passes through the opening to the stomach.

[0131] FIG. 16B depicts the example prosthetic flap valve system 1600 of FIG. 16A with the anchor member 1602 in a closed position and attached to a native tissue flap valve 1612. As mentioned in connection with FIG. 16A, in some embodiments, a portion of the anchor member 1602 is made from a mesh or porous surface. The mesh or porous surface 1610 on the anchor member 1602 is configured to improve tissue regrowth and integration of the prosthesis to native tissue. The mesh 1610, includes a network of small pores or an open mesh structure that encourages cellular infiltration from surrounding native tissue of the flap valve 1612. As cells migrate into the mesh 1610, they initiate the tissue regeneration process, while the open structure promotes vascularization, ensuring a sufficient blood supply for healthy tissue formation. For example, over time, this cellular activity results in the creation of a strong, integrated tissue-prosthesis interface, where new tissue becomes a stable part of the prosthetic flap valve system 1600. This integration improves the stability of the prosthetic flap valve system 1600, reduces the risk of movement or displacement, and improves overall biocompatibility.

[0132] FIG. 16C depicts a side view of the example prosthetic flap valve system 1600 of FIG. 16B with the anchor member 1602 attached to a native tissue flap valve 1612. The side view of the prosthetic flap valve system 1600 show the anchor member 1602 deployed and secured to the native flap valve 1612 by the first end 1604 and the second end 1606. For example, the anchor member 1602 can include tabs or protrusions at the first end 1604. These tabs are configured with a specific geometry that can allow them to pass through the native tissue flap valve 1612 to engage or interlock with corresponding slots or apertures on the second end 1606 of the anchor member 1602. The tabs on the first end 1604 can include a hook or barb-like structure that facilitates secure attachment when inserted into the corresponding receiving features on the second end 1606. For example, the clip features articulating teeth that engage with the tissue at the gastroesophageal junction, securing the valve in place to effectively prevent gastroesophageal reflux. The prosthetic flap valve system 1600 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 1600 can be implanted during a bariatric surgical procedure.

[0133] FIG. 17A depicts another example of a prosthetic flap valve system 1700 with a magnetic anchor members 1712a, 1712b, and 1712c. The structures discussed in reference to FIG. 17A can include the same features and details as those described in reference to FIGS. 1-16C. In the example embodiments depicted by FIG. 17 A, the anchor members 1712a, 1712b, and 1712c each comprise a magnet embedded in a recess having protrusions for gripping native tissue (e.g., the native flap valve 114 of FIG. 1). For example, the prosthetic flap valve can be stabilized with single or multiple magnets incorporated within a mesh. These magnets interact to provide enhanced stabilization of the flap valve at the gastroesophageal junction, ensuring secure placement and effective prevention of gastroesophageal reflux. The magnetized mesh can allow the replacement of the flap valve without the removal of the anchoring mesh from the gastroesophageal junction. The anchor members 1712a, 1712b, and 1712c can be surrounded by a mesh 1710, which facilitates tissue ingrowth and integration when the prosthetic flap valve system 1700 is positioned within the body of a subject. The edges of the mesh of the prosthetic flap valve system 1700 are implanted into native flap valve tissue. This mesh 1710 provides a sufficient surface area for cellular infiltration and vascularization, promoting stable attachment and long-term integration of the prosthetic flap valve 1708 with the native tissue.

[0134] FIG. 17B depicts a side view of the example prosthetic flap valve system 1700 of FIG. 17A with the magnetic anchor members 1712a and 1712b visible. Magnetic anchor member 1712c is not visible in FIG. 17B. The embodiment depicted in FIGS. 17A and 17B include a first end 1704 configured with anchor members 1712a, 1712b, and 1712c that allows it to engage or interlock with a second end 1706. For example, the magnets of the anchor members 1712a, 1712b, and 1712c are oriented with a polarity that directly opposes the polarity of the magnets on the second end 1706. For instance, as depicted in FIG. 17B, anchor member 1712a engages or interlocks with 1712a' and anchor member 1712b engages or interlocks with 1712b'. This opposing polarity configuration means that when the implant is deployed, the magnets align and attract each other, pulling the first end 1704 and second end 1706 together to create a stable and coupled structure. The recesses of the anchor members 1712a, 1712b, 1712a', and 1712b', which house the magnets, are configured to grip the tissue with protrusions while the magnetic attraction helps to maintain the positioning of the prosthetic flap valve system 1700, preventing separation of the ends even under dynamic conditions.

[0135] In operation, prosthetic flap valve system 1700 can be positioned within the target anatomical location (e.g., native tissue flap valve), where the anchor members 1712a, 1712b, 1712a', and 1712b' align and engage with complementary magnetic elements. The protrusions of the recesses can grip the tissue securely, while the mesh 1710 promotes biological integration. This dual mechanism of magnetic attraction and mechanical gripping promotes a stable and durable attachment, accommodating the natural movements of the tissue and maintaining the implant's position over time.

[0136] FIG. 18A depicts another example of a prosthetic flap valve system 1800 comprising magnetic anchor members 1812a, 1812b, and 1812c, and a separate prosthetic flap valve 1808. The structures discussed in reference to FIG. 18A can include similar features and details as those described in reference to FIGS. 1-17B. In the embodiment depicted by FIG. 18A, the prosthetic flap valve system 1800 includes multiple magnet anchor members 1812a, 1812b, and 1812c embedded within recesses. In some embodiments, the anchor members 1812a, 1812b, and 1812c are coupled to a mesh 1810. The anchor members 1812a, 1812b, and 1812c can be positioned within the mesh 1810 to facilitate tissue ingrowth and integration when the mesh 1810 is implanted into native tissue of a subject (e.g., native tissue flap valve

[0137] 114 of FIG. 1). The edges of the mesh prosthetic flap valve system 1800 are implanted into native flap valve tissue. This mesh 1810 provides a sufficient surface area for cellular infiltration and vascularization, promoting stable attachment and long-term integration of the prosthetic flap valve 1808 with the native tissue. FIG. 18B depicts a side view of the example prosthetic flap valve system 1800 of FIG. 18A with the magnetic anchor members 1812a and 1812b visible and separate prosthetic flap valve 1808. Magnetic anchor member 1812c is not visible in FIG. 18B. The embodiment depicted in FIGS. 18A and 18B include a first end 1804 configured with anchor members 1812a, 1812b, and 1812c that allows it to engage or interlock with a second end 1806. For example, the magnets of the anchor members 1812a, 1812b, and 1812c are oriented with a polarity that directly opposes the polarity of the magnets on the second end 1806. For instance, as depicted in FIG. 17B, anchor member 1812a engages or interlocks with 1812a' and anchor member 1812b engages or interlocks with 1812b'. This opposing polarity configuration means that when the implant is deployed, the magnets align and attract each other, pulling the first end 1804 and second end 1806 together to create a stable and coupled structure.

[0138] The recesses of the anchor members 1812a, 1812b, 1812a', and 1812b', which house the magnets, are configured to grip the tissue with protrusions while the magnetic attraction helps to maintain the positioning of the prosthetic flap valve system 1800, preventing separation of the ends even under dynamic conditions. Additionally, since the mesh 1810 can be implanted separately and allowed to integrate with the tissue before attaching the flap valve 1808, the system requires less magnetic force to support the additional weight of the flap valve 1808 This approach enhances the overall stability and durability of the prosthetic flap valve implant.

[0139] In operation, the prosthetic flap valve system 1800 can be implanted using minimally invasive techniques. Initially, the mesh 1810 is positioned within the target anatomical location, and tissue ingrowth is allowed to occur. Once the mesh is fully integrated, the flap valve 1808 is positioned, and the anchor members 1812a, 1812b, align and interlock with the corresponding anchor members 1812a', and 1812b', in the mesh 1810. The mechanical grip provided by the anchor members 1812a, 1812b, 1812a', and 1812b', and the biological integration of the mesh 1810 provide a stable and secure attachment, accommodating natural tissue movements and maintaining the desired functionality of the prosthetic flap valve system 1800 over time.

[0140] FIG. 19A depicts an example prosthetic flap valve system 1900 with an anchor member 1902 in a undeployed position. The structures discussed in reference to FIG. 19A can include the same features and details as those described in reference to FIGS. 1-18B. In the example embodiments depicted by FIG. 19A, the anchor member 1902 comprises a clip that is configured to be slidably disposed over the prosthetic flap valve 1904. The clip anchor member 1902 can include a first side 1903 and a second side 1905. In some embodiments, the clip anchor member 1902 is connected at one end by a flexible hinge or spring mechanism, allowing the first side 1903 and the second side 1905 to pivot relative to each other. The clip anchor member 1902 is configured such that the first side 1903 and the second side 1905 are biased apart.

[0141] In operation, for example, a native flap valve 1912 is placed between the first side 1903 and the second side 1905, the clip anchor member 1902 applies a lateral force on the native flap valve 1912, holding it securely in place by the outward pressure exerted by the first side 1903 and the second side 1905 moving apart. The strength of the grip depends on the tension of the hinge or spring mechanism. The prosthetic flap valve system 1900 can includes a prosthetic flap valve 1904 that can be made from any suitable material. For example, the prosthetic flap valve system 1900 including the prosthetic flap valve 1904 can be made from any biocompatible 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).

[0142] FIG. 19B depicts a side view of the example prosthetic flap valve system 1900 of FIG. 19A with the anchor member 1902 in a deployed position and attached to a native flap valve 1912. The operation described in connection with FIG. 19A is depicted in FIG. 19B. The clip 1902 has been moved toward the larger portion of the native tissue flap valve (indicated by the arrow 1906) the prosthetic flap valve 1904. The placement of a native flap valve 1912 in the prosthetic flap valve 1904 between the first side 1903 and the second side 1905 of the clip anchor member 1902, facilitates the clip anchor member 1902 applying a lateral force on the native flap valve 1912, holding it securely in place by the outward pressure exerted by the first side 1903 and the second side 1905 moving apart. In some embodiments, protrusions 1908 attach to the tissue of the native flap valve 1912 to secure the prosthetic flap valve 1904 in place.

[0143] FIG. 19C depicts the example prosthetic flap valve system 1900 of FIG. 19B with the anchor member 1902 deployed attached to a native flap valve 1912. The embodiment depicted in FIG. 19C includes the features described in connection with FIGS. 19A and 19B. In some embodiments, the prosthetic flap valve 1904 includes raised protrusions 1910 that secure the clip anchor member 1902 in place when it is advanced towards the larger portion of the native tissue flap valve 1912 (as indicated by the arrow 1906 in FIG. 19B). During operation, the prosthetic flap valve 1904 is positioned on the native flap valve 1912 of the subject. The clip anchor member 1902 is then moved towards the larger portion of the native tissue flap valve 1912, sliding over the protrusions 1910. These protrusions 1910 are configured to allow the clip anchor member 1902 to pass over them in one direction but prevent it from moving backward, effectively locking the clip anchor member 1902 in position. The protrusions 1910 can be shaped with angled or ramped surfaces that facilitate forward movement of the clip anchor member 1902 while opposing any reverse motion, ensuring the clip anchor member 1902 remains securely in place once engaged.

[0144] FIG. 20A depicts an example of a prosthetic flap valve system 2000 that includes a bioabsorbable anchor member 2002 connected to a silicone body of the prosthetic flap valve 2012. The structures discussed in reference to FIG. 20A may include similar features and details as those described in reference to FIGS. 1-19C. In this embodiment, an bioabsorbable anchor member 2002 is molded from a bioabsorbable material and is configured to provide a clamping force on a native flap valve tissue of a subject at the time of implantation. Nonlimiting examples of bioabsorbable materials include polylactic acid (PLA), polyglycolic acid (PGA), and polycaprolactone (PCL), which are configured to be safely absorbed and gradually broken down by the body over time, providing temporary structural support before degrading naturally. Over time, as tissue ingrowth occurs into a mesh 2004, the bioabsorbable anchor member 2002 gradually softens and is absorbed to the native tissue, ultimately leaving a soft implant inside the subject. The bioabsorbable anchor member 2002 includes a first side 2008 coupled to a first side 2009 of the prosthetic flap valve 2012 and a second side 2010 coupled to a second side 2011 of the prosthetic flap valve 2012.

[0145] FIG. 20B is a side view of the example prosthetic flap valve system 2000 of FIG. 20A that includes a bioabsorbable anchor member 2002 connected to a silicone body of the prosthetic flap valve 2012. The bioabsorbable anchor member 2002 in a deployed state, is configured to securely clamp the soft silicone body of the prosthetic flap valve 2012 to the native tissue flap valve of a subject. The bioabsorbable anchor member 2002 is configured to exert an initial clamping force that engages the prosthetic flap valve 2012 is securely anchored to the native tissue. As tissue grows into the mesh 2004, the bioabsorbable anchor member 2002 begins to degrade, reducing its rigidity and allowing the prosthetic flap valve 2012 to conform to the surrounding native tissue. The mesh 2004 serves as the primary interface for tissue integration, promoting cellular infdtration and vascularization, which stabilizes the prosthetic flap valve 2012 over time.

[0146] In some embodiments, the prosthetic flap valve system 2000 includes protrusions 2014 on the bioabsorbable anchor member 2002 that are configured to interact with the native tissue, providing a secure initial grip. These protrusions 2014 are angled to allow the bioabsorbable anchor member 2002 to move forward over the native flap valve tissue while preventing backward movement, effectively locking the bioabsorbable anchor member 2002 in place. As the bioabsorbable material degrades, these protrusions 2014 also soften, reducing any potential for irritation or pressure points within the tissue.

[0147] FIG. 20C is another side view of the example prosthetic flap valve system 2000 of FIG. 20A that includes a bioabsorbable anchor member 2002 connected to a silicone body of the prosthetic flap valve 2012 and an implant tool 2006. The embodiment depicted in FIG. 19C includes the features described in connection with FIGS. 20A and 20B. The embodiments depicted in FIG. 20C depicts an implant tool 2006. In some instances, the implant tool 2006 functions similarly to a clothespin, and is configured to open the bioabsorbable anchor member 2002 when attaching it to the native tissue flap valve of a subject. The bioabsorbable anchor member 2002 are biased to a closed state where the first side 2008 and the second side 2010 are biased together due to its configuration, which provides a clamping force without constant external pressure. The implant tool 2006 can be inserted during a procedure to temporarily open the bioabsorbable anchor member 2002 where the first side 2008 and the second side 2010 moved apart by the implant tool 2006, allowing the prosthetic flap valve 2012 to be positioned around the native flap valve tissue. Once in place, the implant tool 2006 is removed, and the bioabsorbable anchor member 2002 can return to its closed state, securing the prosthetic flap valve system 2000 to the native tissue.

[0148] The configuration described by FIGS. 20A-20C allow for a minimally invasive implantation process, where the bioabsorbable anchor member 2002 provides strong initial fixation, and as the tissue integration progresses, the clip material degrades, leaving behind a soft, biocompatible implant that conforms naturally to the subject’s anatomy. The combination of the bioabsorbable anchor member 2002 and the mesh 2004 promotes both mechanical stability at the time of implantation and long-term biological integration.

[0149] FIG. 21 A depicts an example of a prosthetic flap valve system 2100 that includes a bent clip anchor member 2102 connected to a silicone body of the prosthetic flap valve 2106. The bent clip anchor member 2102 can be made from any suitable material. In some embodiments, bent clip anchor member 2102 is metal. Non-limiting examples of metal can include one or more of wherein the metal is one or more of nitinol, memory wire, or a synthetic or biological mesh skeleton with the capability to alter the shape and prosthetic flap valve direction to either permit the passage of food or prevent gastroesophageal reflux.

[0150] In some embodiments, the bent clip anchor member 2102 is covered in mesh 2104. The bent clip anchor member 2102 The structures discussed in reference to FIG. 21A may include similar features and details as those described in reference to FIGS. 1-20C. In this embodiment, the bent clip anchor member 2102 provides a clamping force at the time of implantation. The bent clip anchor member 2102 includes offset "teeth" 2110 that prevent significant puncture of the native tissue flap valve while still providing a secure grip. The mesh 2104 surrounding the bent clip anchor member 2102 facilitates tissue ingrowth over time, promoting stable attachment and long-term integration of the prosthetic flap valve system 2100 with the native tissue.

[0151] FIG. 21B is a side view of the example prosthetic flap valve system 2100 of FIG. 21A that includes a bent clip anchor member 2102 connected to a silicone body of the prosthetic flap valve 2106. The prosthetic flap valve system depicted in FIGS. 21A-21C comprises one or more actuating levers 2114 at approximately 90 degrees to the main arms 2116a and 2116b of the bent clip anchor member 2102. The bent design allows the actuating levers 2114 to be more easily contained within the profile of the silicone body of the prosthetic flap valve 2106, minimizing the overall footprint of the prosthetic flap valve system 2100. The bent clip anchor member 2102 is configured to provide a strong initial clamping force, ensuring that the prosthetic flap valve 2106 is securely anchored to the native tissue flap valve. Over time, the mesh 2104 allows for tissue ingrowth, further stabilizing the prosthetic flap valve system 2100 as the metal clip anchor member 2102 remains embedded in the tissue.

[0152] FIG. 21C is another side view of the example prosthetic flap valve system 2100 of FIG. 21 A and FIG. 2 IB that includes a bent clip anchor member 2102 connected to a silicone body of the prosthetic flap valve 2106 and an implant tool 2118. In some embodiments, the implant tool 2118, is a scope with coaxial action capabilities. For example, the implant tool 2118 can be configured to open the metal clip 2102 during the procedure by applying a rotational or linear coaxial motion. This action temporarily opens the main arms 2116a and 2116b of the bent clip anchor member 2102, allowing the prosthetic flap valve 2106 to be positioned securely around the native tissue flap valve. Once the bent clip anchor member 2102 is in the desired position, the implant tool 2118 is withdrawn, allowing the bent clip anchor member 2102 to close and secure the prosthetic flap valve system 2100 in place. The control offered by the coaxial action of the implant tool 2118 promotes accurate placement and secure attachment of the prosthetic flap valve system 2100.

[0153] This configuration is described by FIGS. 21A-21C allows for a minimally invasive implantation process, where the bent clip anchor member 2102 provides strong initial fixation. As tissue integration progresses through the mesh 2104, the bent clip anchor member 2102 remains securely embedded, contributing to the long-term stability and biocompatibility of the prosthetic flap valve system 2100 within the subject’s anatomy.

[0154] FIG. 22A depicts an example of a prosthetic flap valve system 2200 that includes a clip anchor member 2204 and a prosthetic flap valve 2202. The clip anchor member 2204 can be made from any suitable material. In some embodiments, clip anchor member 2102 is metal. In some embodiments, the clip anchor member 2204 is covered in mesh 2210. The structures discussed in reference to FIG. 22A may include features and details similar to those described in reference to FIGS. 1-21C. In some embodiments, the clip anchor member 2102 is separate from the prosthetic flap valve 2202. In some embodiments, the clip anchor member 2204 is coupled to the prosthetic flap valve 2202. In some embodiments, the clip anchor member 2102 includes "teeth" that provide a secure grip to the native flap valve when implanted. The mesh 2204 surrounding the clip anchor member 2102 facilitates tissue ingrowth over time, promoting stable attachment and long-term integration of the prosthetic flap valve system 2200 with the native tissue. The clip anchor member 2204 can include a first side 2206 and a second side 2208 that can be biased together and apart with a spring 2212. The spring 2212 can be any suitable spring disclosed herein. For example, the spring 2212 can be a clothespin-type spring, where a compression or tension spring is used to keep the sides 2206 and 2208 biased together, applying a constant clamping force. Alternatively, for example, the spring 2212 could be a torsion spring, which is positioned at the pivot point between the first side 2206 and the second side 2208, exerting a rotational force that either opens or closes the clip anchor member 2204 depending on its orientation. In some embodiments, the first side 2206 and a second side 2208 can be biased together and apart with a balloon that is inflated and deflated within the wedge formed opposite the first side 2206 and a second side 2208.

[0155] FIG. 22B is the example prosthetic flap valve system 2200 of FIG. 22A that includes a clip anchor member 2204 connected to a native flap valve 2214 and a prosthetic flap valve 2202. In operation, for example, a native flap valve 2214 is placed between the first side 2206 and the second side 2208, the clip anchor member 2204 applies a force on the native flap valve 2214, holding it securely in place by the inward pressure exerted by the first side 2206 and the second side 2208 moving together. The strength of the grip depends on the tension of the hinge or spring mechanism. The prosthetic flap valve system 2200 can include a prosthetic flap valve 2202 that can be made from any suitable material. For example, the prosthetic flap valve system 1900 including the prosthetic flap valve 1904 can be made from any biocompatible 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).

[0156] FIG. 23A depicts an example of a prosthetic flap valve system 2300 that includes a gastric stent 2302 and a clip anchor member of a silicone flap valve 2304. The gastric stent 2302 is configured to be positioned in the lower esophagus, either below or above the LES, depending on the specific anatomical and medical requirements of the subject. The gastric stent 2302 is a structural support within the esophagus, while the attached silicone flap 2304 acts as a functional barrier, helping to manage or prevent reflux by mimicking the natural closure mechanism of the esophagus.

[0157] FIG. 23B depicts an example of a prosthetic flap valve system 2300 of FIG. 23 A that includes a gastric stent 2302 and a clip anchor member of a silicone flap valve 2304 coupled to a native flap valve 2306. The silicone flap 2304 is shown attached to the stent 2302, extending downward to interact with the surrounding esophageal or gastric tissue. The silicone flap 2304 is configured to move in conjunction with the tissue, creating a dynamic seal that responds to the physiological movements of the esophagus and stomach. The flexibility and softness of the silicone flap 2304 allow it to conform closely to the tissue, ensuring a snug fit and effective prevention of reflux. In some embodiments, a first end 1604 is configured with a specific geometry that allows it to engage or interlock with a second end 1606. For example, the first end 1604 can include tabs or protrusions configured to engage or interlock with corresponding slots or apertures on the second end of the anchor member 1602. The prosthetic flap valve system 1600 can include a prosthetic flap valve 1608 that can be made from any suitable material. For example, the prosthetic flap valve system 1600 including the prosthetic flap valve 1608 can be made from any biocompatible prosthetic material selected from polymer, silicone, hydrogel, collagen-based material, a composite material, or biological material (e.g., animal tissue, cultured tissue, or cadaver tissue).

[0158] In some embodiments, a portion of the anchor member 1602 is made from a mesh or porous surface, which provides an area for tissue ingrowth or material integration when inserted into the tissue of a subject (e.g., the native flap valve 114 of FIG. 1). The mesh surface 1610 improves the stability and integration of the anchor member 1602 within the surrounding biological tissue.

[0159] In operation, the prosthetic flap valve 1608 can elongate the exiting native tissue flap valve of the subject to improve symptoms of gastric reflux or GERD. For example, the prosthetic flap valve 1608 is configured to bias to a closed position that provides a separation between the esophagus and the stomach. During a swallowing operation the prosthetic flap valve 1608 can move from a closed position to an open position, where the open position moves the prosthetic flap valve 1608 from a position towards the lesser curvature (e.g., 134 of FIG. 1) toward the greater curvature 232 of FIG. 2) such that food or liquid passes through the opening to the stomach.

[0160] FIG. 16B depicts the example prosthetic flap valve system 1600 of FIG. 16A with the anchor member 1602 in a closed position and attached to a native tissue flap valve 1612. As mentioned in connection with FIG. 16A, in some embodiments, a portion of the anchor member 1602 is made from a mesh or porous surface. The mesh or porous surface 1610 on the anchor member 1602 is configured to improve tissue regrowth and integration of the prosthesis to native tissue. The mesh or porous surface 1610, includes a network of small pores or an open mesh structure that encourages cellular infiltration from surrounding native tissue of the flap valve 1612. As cells migrate into the mesh or porous surface 1610, they initiate the tissue regeneration process, while the open structure promotes vascularization, ensuring a sufficient blood supply for healthy tissue formation. For example, over time, this cellular activity results in the creation of a strong, integrated tissue-prosthesis interface, where new tissue becomes a stable part of the prosthetic flap valve system 1600. This integration improves the stability of the prosthetic flap valve system 1600, reduces the risk of movement or displacement, and improves overall biocompatibility.

[0161] OTHER EMBODIMENTS 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

WHAT IS CLAIMED IS:

1. A prosthetic flap valve system, comprising: 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 a subject; 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 the closed position of the flap valve provides a separation between the esophagus and the stomach.

2. The system of claim 1, wherein the elongation member is one of a compression spring, an extension spring, a torsion spring, or an elastic band.

3. The system of claim 1 or claim 2, 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.

4. The system of any one of claims 1-3, wherein the flap valve is a non-prosthetic flap valve.

5. The system of any one of claims 1-4, 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.

6. The system of any one of claims 1-4, wherein the first anchor member is configured to couple the first end of the elongation member to the gastric wall portion is toward thegreater curvature of the stomach such that the elongation member is compressed when the flap valve is biased in an open position.

7. The system of any one of claims 1-6, wherein the elongation member, the first anchor member, and the second anchor member are configured to be implanted within the subject endoscopically, laparoscopically, or both.

8. A prosthetic flap valve system, comprising: 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 the closed position of the prosthetic flap valve provides a separation between the esophagus and the stomach of the subject.

9. The system of claim 8, wherein the gasket is configured to interface the prosthetic flap valve to tissue of the subject when biased in the closed position.

10. The system of claim 9, wherein the gasket is made from a silicone material.

11. The system of any one of claims 8-10, 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.

12. The system of any one of claims 8-11, further comprising one or more magnets coupled to the second end of the prosthetic valve, wherein the one or more magnets areconfigured 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.

13. The system of any one of claims 8-12, wherein the prosthetic flap valve is made from one or more materials selected from polymer, silicone, hydrogel, collagen-based material, a composite material, or biological materials.

14. The system of any one of claims 8-13, wherein the one or more anchor members are aligned within a frame on the first end of the prosthetic valve.

15. The system of claim 14, wherein the frame is configured to secure the first end of the prosthetic flap valve to the gastric wall adjacent to the greater curvature of the stomach.

16. The system of claim 15, further comprising a membrane positioned within the prosthetic flap valve, wherein the frame is configured to secure the membrane taunt such that is covers the opening to the esophagus.

17. The system of any one of claims 14-16, wherein a portion of the membrane that is proximate to the second end of the prosthetic flap valve provides an opening between the prosthetic flap valve and the gastric wall toward the lesser curvature of the stomach.

18. The system of claim 16 or claim 17, wherein the membrane is made from one or more flexible materials selected from silicone, hydrogel, biocompatible fabric, or biocompatible polymer.

19. The system of any one of claims 8-18, wherein the prosthetic flap valve and the one or more anchor members are configured to be implanted within the subject endoscopically, laparoscopically, or both.

20. A method for implanting a prosthetic flap valve system into a subject, comprising: identifying a subject has having GERD and / or hiatal hernia;determining a treatment based on a severity of the GERD, the presence or absence of native flap valve, and / or hiatal hernia size; and implanting any one of the prosthetic flap valve systems of claims 1-19 in the gastroesophageal junction of the subject, wherein the implanting is performed via endoscopically, laparoscopically, or both.

21. A prosthetic flap valve system, comprising: a prosthetic flap valve having a first end and a second end; a first anchor member coupled to the first end of the prosthetic flap valve and configured to couple the first end of the prosthetic flap valve to a portion of a native flap valve of a subject; a second anchor member coupled to the second end of the prosthetic flap valve and configured to couple the second end of the prosthetic flap valve to a different portion of the native flap valve, wherein: the prosthetic flap valve is configured to bias the flap valve to a closed position; and the closed position of the flap valve provides a separation between the esophagus and the stomach.

22. The prosthetic flap valve of claim 21, wherein the prosthetic flap valve comprises a silicon-base or other polymer or biologic outer structure with an inner core composed of metal.

23. The prosthetic flap valve of any one of claims 21-22, wherein the metal is one or more of nitinol, memory wire, a synthetic or biologic mesh skeleton with the capability to alter the shape and / or direction of the prosthetic flap valve to either permit the passage of food or prevent gastroesophageal reflux.

24. The prosthetic flap valve of any one of claims 22-23, wherein the silicon-base outer structure has a variable thickness configured to adapt to fit at the gastroesophageal junction.

25. The prosthetic flap valve of any one of claims 22-23, wherein the prosthetic flap valve is sized in one or more of an oval, a rectangle, a cone, or a roll-out.

26. The prosthetic flap valve of claim 21, further comprising a mesh component, wherein the mesh component of the clip allows for tissue ingrowth at the gastroesophageal junction, promoting long-term integration and anchoring of the valve.

27. The prosthetic flap valve of claim 26, wherein the mesh component comprises one or more recesses comprising magnets.

28. The prosthetic flap valve of claim 21, wherein the first anchor member and the second anchor member comprise hooks or barbs configured to secure the prosthetic flap valve to the native flap valve.

29. The prosthetic flap valve of claim 21, wherein the first anchor member and the second anchor member are bent and configured to secure the prosthetic flap valve to the native flap valve.

Images