Gastroesophageal reflux reduction system having a stomach component and a CRUS component

Abstract

Systems and methods for preventing migration of a gastroesophageal junction of a stomach through an esophageal hiatus of a diaphragm are provided. The system includes a stomach component engageable with a wall of an esophagus of a patient, in a section of the esophagus extending from the gastroesophageal junction and the diaphragm, and a crus component fixedly engageable with a right bundle and a left bundle of a diaphragm crus. The stomach component comprises a stomach ring defining an esophagus receiving opening, and a stomach component magnet coupled with the stomach ring. The crus component includes a V-shape frame having a right bundle arm and a left bundle arm joined together at a crus component magnet intersection, and a crus component magnet located at the crus component magnet intersection and configured to be magnetically coupled to the stomach component magnet once brought in sufficiently close proximity.

Description

GASTROESOPHAGEAL REFLUX REDUCTION SYSTEM HAVING A STOMACH COMPONENT AND A CRUS COMPONENTTECHNICAL FIELD

[0001] The technical field relates to systems, devices and methods for treating gastroesophageal reflux disease. More particularly, the technical field relates to systems, devices and methods for maintaining a gastroesophageal junction at a given position within the abdominal cavity.BACKGROUND

[0002] Gastroesophageal reflux disease (GERD) can be defined as the presence of symptoms or complications that are directly related to the retrograde flow of gastric contents into the esophagus. A certain degree of reflux is normal, and the development of GERD involves either increased esophageal exposure to gastric juice or a reduced threshold for epithelial injury and symptom perception. This balance among reflux exposure, epithelial resistance, and visceral sensitivity is delicate, and can be altered by perturbations in physiologic and anatomical factors that either promote or impede reflux into the esophagus, or protect or injure the epithelium from exposure to gastric juice.

[0003] Under normal circumstances, reflux into the esophagus is prevented by the antireflux barrier, which is a complex anatomic zone made up of multiple components, including the lower esophageal sphincter, the extrinsic crural diaphragm, and the supporting structures of the gastroesophageal flap valve. When these protective components are compromised, the deleterious effects can be additive, resulting in increasing numbers of reflux events and increasingly abnormal esophageal reflux exposure. When gastric juice enters the esophagus, protective factors help clear the refluxate from the esophagus and protect the epithelium. Breakdown of these protective forces can also promote reflux disease. Complications and symptoms can also occur in individuals with a normal reflux burden, when there is either poor epithelial resistance or increased visceral sensitivity. The pathogenesis of GERD is therefore complex and determined by interactions among multiple aggressive and defensive factors.

[0004] Primary treatment goals in patients with GERD include relief of symptoms, prevention of symptom relapse, healing of erosive esophagitis, and prevention of complications of esophagitis. In patients with reflux esophagitis, treatment is directed at acid suppression through the use of lifestyle modifications (e.g., elevating the head of the bed, modifying thesize and composition of meals. Etc.) and pharmacologic agents such as antiacids (Turns™, Rolaids™, etc.), histamine H2-receptor antagonists, or proton pump inhibitors.

[0005] However, these lifestyle modifications and pharmacological approaches may have a limited chance of success. In such cases, antireflux surgery, including open and laparoscopic versions of Nissen fundoplication, can be an alternative treatment in patients who have chronic reflux with recalcitrant symptoms. Nevertheless, these surgeries can be invasive, and the risk of complications may be high.

[0006] An alternative approach to surgery can involve the implantation of a prosthetic device around a patient's lower esophageal sphincter (LES) to resiliently apply a radially inwardly directed force, in a sphincter-like fashion, to prevent gastric juices from refluxing into the esophagus. The prosthetic device can include a plurality of magnetic bodies arranged in a series so that each magnetic body is magnetically attracted to the next adjacent magnetic bodies in the series to apply the radially inwardly directed force to the LES. However, this approach has several drawbacks, and has proven not particularly effective at preventing GERD.

[0007] Accordingly, there remain a number of challenges with respect to treating GERD, and in particular, challenges related to medical devices that can be implanted in a patient’s body for reducing GERD.SUMMARY

[0008] In accordance with an aspect, there is provided a gastroesophageal reflux reduction system for preventing migration of a gastroesophageal junction of a stomach through an esophageal hiatus of a diaphragm, the system comprising: a stomach component engageable with a wall of an esophagus of a patient, the stomach component being positionable against an esophageal outer surface of the esophagus, in a section of the esophagus extending from the gastroesophageal junction and the diaphragm, the stomach component comprising: a stomach ring comprising an inward surface defining an esophagus receiving opening; and a stomach component magnet coupled with the stomach ring;a crus component fixedly engageable with a right bundle and a left bundle of a diaphragm crus, the crus component comprising: a V-shape frame having a right bundle arm and a left bundle arm joined together at a crus component magnet intersection; and a crus component magnet located at the crus component magnet intersection and configured to be magnetically coupled to the stomach component magnet once brought in sufficiently close proximity; wherein when the stomach component magnet and the crus component magnet are magnetically coupled to each other, an upward movement of the gastroesophageal junction is limited, and the gastroesophageal junction is prevented from migrating through the esophageal hiatus.

[0009] In some implementations, the stomach component magnet is received within a thickness of the stomach ring.

[0010] In some implementations, the stomach ring comprises an outwardly protruding section configured to receive the stomach component magnet.

[0011] In some implementations, the stomach ring comprises a dome-shape protrusion configured to receive the stomach component magnet.

[0012] In some implementations, the stomach ring is shaped as a torus.

[0013] In some implementations, the crus component magnet intersection is configured for positioning at a lower base of a convergence of the right bundle and the left bundle.

[0014] In some implementations, the stomach component magnet is configured for positioning at a posterior location around the esophagus.

[0015] In some implementations, the stomach component is positionable at the gastroesophageal junction.

[0016] In some implementations, the right bundle and the left bundle originate from a right crus of the diaphragm crus, such that the right bundle arm and the left bundle arm are both fixedly engageable with the right crus, on either side of the esophagus.

[0017] In some implementations, the right bundle and the left bundle originate from a right crus and a left crus of the diaphragm crus respectively, such that the right bundle arm and the left bundle arm are fixedly engageable with the right crus and the left crus respectively, on either side of the esophagus.

[0018] In some implementations, the stomach component further comprises a ring connector enabling the stomach ring to transition from a close configuration to an open configuration.

[0019] In some implementations, the ring connector is provided in a ring connector quadrant located opposite a stomach component magnet quadrant in which the stomach component magnet is located.

[0020] In some implementations, the ring connector is located diametrically opposite to the stomach component magnet.

[0021] In some implementations, the stomach component is made of a stomach component material comprising a biocompatible polymer.

[0022] In some implementations, the stomach component material comprises silicone.

[0023] In some implementations, the stomach component material comprises polyethylene.

[0024] In some implementations, the stomach component magnet comprises a crus component magnet engaging surface that is substantially flat.

[0025] In some implementations, the crus component magnet comprises a stomach component magnet engaging surface that is substantially flat.

[0026] In some implementations, the stomach component magnet comprises a crus component magnet engaging surface having a surface roughness.

[0027] In some implementations, the crus component magnet comprises a stomach component magnet engaging surface having a complementary surface roughness to that of the crus component magnet engaging surface of the stomach component magnet.

[0028] In some implementations, the stomach component magnet is enclosed in a stomach component magnet housing made of a stomach component magnet housing material.

[0029] In some implementations, the stomach component magnet housing fully encloses the stomach component magnet.

[0030] In some implementations, the stomach component magnet housing comprises a crus component magnet engaging surface that is substantially flat.

[0031] In some implementations, the crus component magnet comprises a stomach component magnet engaging surface that is substantially flat.

[0032] In some implementations, the stomach component magnet housing comprises a crus component magnet engaging surface having a surface roughness.

[0033] In some implementations, the crus component magnet comprises a stomach component magnet engaging surface having a complementary surface roughness to that of the crus component magnet engaging surface of the stomach component magnet housing.

[0034] In some implementations, the stomach component magnet housing material comprises titanium.

[0035] In some implementations, the crus component is made of a crus component material comprising a biocompatible polymer.

[0036] In some implementations, the crus component material comprises silicone.

[0037] In some implementations, the crus component material comprises polyethylene.

[0038] In some implementations, an attractive magnetic force between the stomach component magnet and the crus component magnet is selected such that the stomach component magnet and the crus component magnet are alternately magnetically engaged and magnetically disengaged in reaction to swallowing movements once the stomach component and the crus component are implanted around the esophagus and at the diaphragm crus, respectively.

[0039] In some implementations, the stomach component is fixedly engageable with the wall of the esophagus.

[0040] In some implementations, the crus component comprises a hinge at the crus component magnet intersection to move the right bundle arm and the left bundle arm of the V-shape frame relative to each other.

[0041] In some implementations, the stomach component magnet comprises a plurality of magnets.

[0042] In some implementations, the crus component magnet comprises a plurality of magnets.

[0043] In some implementations, the stomach ring comprises a multiple stomach ring units provided adjacent to each other in a side-to-side fashion.

[0044] In some implementations, the stomach component further comprises a ring connector enabling the stomach ring to transition from a close configuration to an open configuration.

[0045] In accordance with another aspect, there is provided a stomach component engageable with a wall of an esophagus of a patient as part of a gastroesophageal reflux reduction system for preventing migration of a gastroesophageal junction of a stomach through an esophageal hiatus of a diaphragm, the stomach component comprising: a stomach ring comprising an inward surface defining an esophagus receiving opening; and a stomach component magnet coupled with the stomach ring; wherein the stomach component is positionable against an esophageal outer surface of the esophagus, in a section of the esophagus extending from the gastroesophageal junction and the diaphragm; and wherein the stomach component magnet is configured to be magnetically attracted to a crus component magnet of a crus component to limit an upward movement of the gastroesophageal junction and prevent the gastroesophageal junction from migrating through the esophageal hiatus.

[0046] In some implementations, the stomach component magnet is received within a thickness of the stomach ring.

[0047] In some implementations, the stomach ring comprises an outwardly protruding section configured to receive the stomach component magnet.

[0048] In some implementations, the stomach ring comprises a dome-shape protrusion configured to receive the stomach component magnet.

[0049] In some implementations, the stomach ring is shaped as a torus.

[0050] In some implementations, the stomach component magnet is configured for positioning at a posterior location around the esophagus.

[0051] In some implementations, the stomach component is positionable at the gastroesophageal junction.

[0052] In some implementations, the stomach component further comprises a ring connector enabling the stomach ring to transition from a close configuration to an open configuration.

[0053] In some implementations, the ring connector is provided in a ring connector quadrant located opposite a stomach component magnet quadrant in which the stomach component magnet is located.

[0054] In some implementations, the ring connector is located diametrically opposite to the stomach component magnet.

[0055] In some implementations, the stomach component is made of a stomach component material comprising a biocompatible polymer.

[0056] In some implementations, the stomach component material comprises silicone.

[0057] In some implementations, the stomach component material comprises polyethylene.

[0058] In some implementations, the stomach component magnet comprises a crus component magnet engaging surface that is substantially flat.

[0059] In some implementations, the stomach component magnet comprises a crus component magnet engaging surface having a surface roughness.

[0060] In some implementations, the stomach component magnet is enclosed in a stomach component magnet housing made of a stomach component magnet housing material.

[0061] In some implementations, the stomach component magnet housing fully encloses the stomach component magnet.

[0062] In some implementations, the stomach component magnet housing comprises a crus component magnet engaging surface that is substantially flat.

[0063] In some implementations, the stomach component magnet housing comprises a crus component magnet engaging surface having a surface roughness.

[0064] In some implementations, the stomach component magnet housing material comprises titanium.

[0065] In some implementations, the stomach component is fixedly engageable with the wall of the esophagus.

[0066] In some implementations, the stomach component magnet comprises a plurality of magnets.

[0067] In some implementations, the stomach ring comprises a multiple stomach ring units provided adjacent to each other in a side-to-side fashion.

[0068] In some implementations, the stomach component further comprises a ring connector enabling the stomach ring to transition from a close configuration to an open configuration.

[0069] In accordance with another aspect, there is provided a crus component of a gastroesophageal reflux reduction system for preventing migration of a gastroesophageal junction of a stomach through an esophageal hiatus of a diaphragm, the crus component comprising: a crus component fixedly engageable with a right bundle and a left bundle of a diaphragm crus, the crus component comprising: a V-shape frame having a right bundle arm and a left bundle arm joined together at a crus component magnet intersection; and a crus component magnet located at the crus component magnet intersection and configured to be magnetically coupled to a stomach component magnet of a stomach component once brought in sufficiently close proximity; wherein when the crus component magnet and the stomach component magnet are magnetically coupled to each other, an upward movement of the gastroesophageal junction is limited, and the gastroesophageal junction is prevented from migrating through the esophageal hiatus.

[0070] In some implementations, the crus component magnet intersection is configured for positioning at a lower base of a convergence of the right bundle and the left bundle.

[0071] In some implementations, the right bundle and the left bundle originate from a right crus of the diaphragm crus, such that the right bundle arm and the left bundle arm are both fixedly engageable with the right crus, on either side of the esophagus.

[0072] In some implementations, the right bundle and the left bundle originate from a right crus and a left crus of the diaphragm crus respectively, such that the right bundle arm and the left bundle arm are fixedly engageable with the right crus and the left crus respectively, on either side of the esophagus.

[0073] In some implementations, the crus component magnet comprises a stomach component magnet engaging surface that is substantially flat.

[0074] In some implementations, the crus component magnet comprises a stomach component magnet engaging surface having a complementary surface roughness to that of a crus component magnet engaging surface of the stomach component magnet.

[0075] In some implementations, the crus component is made of a crus component material comprising a biocompatible polymer.

[0076] In some implementations, the crus component material comprises silicone.

[0077] In some implementations, the crus component material comprises polyethylene.

[0078] In some implementations, the crus component comprises a hinge at the crus component magnet intersection to move the right bundle arm and the left bundle arm of the V-shape frame relative to each other.

[0079] In some implementations, the crus component magnet comprises a plurality of magnets.

[0080] In some implementations, there is provided a method for preventing migration of a gastroesophageal junction of a stomach through an esophageal hiatus of a diaphragm, the method comprising: positioning a stomach component against an esophageal outer surface of an esophagus of a patient, in a section of the esophagus extending from thegastroesophageal junction and the diaphragm, such that the esophagus passes through an esophagus receiving opening of a stomach ring of the stomach component; orienting a stomach component magnet of the stomach component in a posterior location relative to the stomach such that the stomach component magnet faces a diaphragm crus; fixedly engaging a crus component with a right bundle and a left bundle of the diaphragm crus, comprising: engaging a right bundle arm of a V-shape frame of the crus component with a right bundle of the diaphragm crus; engaging a left bundle arm of the V-shape frame of the crus component with a left bundle of the diaphragm crus, the right bundle arm and the left bundle arm being joined together at a crus component magnet intersection; orienting a crus component magnet of the crus component in an anterior location relative to the diaphragm crus such that the crus component magnet faces the stomach, the crus component magnet being located at the crus component magnet intersection; magnetically coupling the stomach component magnet and the crus component magnet.

[0081] In some implementations, the right bundle and the left bundle originate from a right crus of the diaphragm crus, and engaging the right bundle arm and the left bundle arm with the right bundle and the left is performed by engaging the right bundle arm and the left bundle arm with the right crus, on either side of the esophagus.

[0082] In some implementations, the right bundle and the left bundle originate from a right crus and a left crus of the diaphragm crus respectively, and engaging the right bundle arm and the left bundle arm with the right bundle and the left is performed by engaging the right bundle arm and the left bundle arm with the right crus and the left crus respectively, on either side of the esophagus.

[0083] In some implementations, positioning the stomach component against the esophageal outer surface is performed surgically or laparoscopically.

[0084] In some implementations, fixedly engaging the crus component with the right bundle and the left bundle of the diaphragm crus is performed surgically or laparoscopically.

[0085] In some implementations, fixedly engaging the crus component with the right bundle and the left bundle of the diaphragm crus comprises suturing the right bundle arm to the right bundle and / or suturing the left bundle arm to the left bundle.

[0086] In some implementations, the method further comprises exerting a radial inward force onto the esophagus via the stomach ring.

[0087] In some implementations, the method further comprises fixedly engaging the stomach component with the wall of the esophagus.

[0088] In some implementations, fixedly engaging the stomach component with the wall of the esophagus comprises suturing the stomach component to the wall of the esophagus.

[0089] In accordance with another aspect, there is provided a method for preventing migration of a gastroesophageal junction of a stomach through an esophageal hiatus of a diaphragm, the method comprising: positioning a stomach component against an esophageal outer surface of an esophagus of a patient, in a section of the esophagus extending from the gastroesophageal junction and the diaphragm, such that the esophagus passes through an esophagus receiving opening of a stomach ring of the stomach component, the stomach component comprising a stomach component magnet; fixedly engaging a crus component with a right bundle and a left bundle of a diaphragm crus, the crus component comprising a crus component magnet; magnetically coupling the stomach component magnet and the crus component magnet.

[0090] In some implementations, positioning the stomach component against the esophageal outer surface is performed surgically or laparoscopically.

[0091] In some implementations, fixedly engaging the crus component with the right bundle and the left bundle of the diaphragm crus is performed surgically or laparoscopically.

[0092] In some implementations, fixedly engaging the crus component with the right bundle and the left bundle of the diaphragm crus comprises suturing the crus component with the right bundle and / or the left bundle.

[0093] In some implementations, the method further comprises exerting a radial inward force onto the esophagus via the stomach ring.

[0094] In some implementations, the method further comprises fixedly engaging the stomach component with the wall of the esophagus.

[0095] In some implementations, fixedly engaging the stomach component with the wall of the esophagus comprises suturing the stomach component to the wall of the esophagus.

[0096] In some implementations, the system further comprises one or more features as defined and / or illustrated herein.

[0097] In some implementations, the stomach component further comprises one or more features as defined and / or illustrated herein.

[0098] In some implementations, the crus component further comprises one or more features as defined and / or illustrated herein.

[0099] In some implementations, the method further comprises one or more features as defined and / or illustrated herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0100] The attached figures illustrate various features, aspects and implementations of the technology described herein.

[0101] Fig 1 is a schematic representation of a digestive tract of a patient, with an enlarged view of a gastroesophageal junction.

[0102] Fig 2 is another schematic representation of a digestive tract of a patient, with an enlarged view of a hiatal hernia.

[0103] Fig 3 is a schematic representation of a crura of a diaphragm, the crura of the diaphragm including a right crus and a left crus.

[0104] Fig 4 is another schematic representation of a crura of a diaphragm, the crura of the diaphragm including a right crus and a left crus.

[0105] Fig 5 is a front view of a stomach component of a gastroesophageal reflux reduction system, in accordance with an implementation.

[0106] Fig 6 is a side perspective view of the stomach component of Fig 5.

[0107] Fig 7 is a front view of a stomach component of a gastroesophageal reflux reduction system, in accordance with another implementation.

[0108] Fig 8 is a front view of a stomach component of a gastroesophageal reflux reduction system including a plurality of magnets, in accordance with another implementation.

[0109] Fig 9 is a front view of a stomach component of a gastroesophageal reflux reduction system, in accordance with another implementation.

[0110] Fig 10 is a front view of a stomach component of a gastroesophageal reflux reduction system, in accordance with another implementation.

[0111] Fig 11 is a front view of a stomach component of a gastroesophageal reflux reduction system including multiple stomach ring units provided adjacent to each other in a side-to-side fashion, in accordance with another implementation.

[0112] Fig 12 is a front view of a crus component of a gastroesophageal reflux reduction system, in accordance with an implementation.

[0113] Fig 13 is a side perspective view of the crus component of Fig 12.

[0114] Fig 14 is a front view of a crus component of a gastroesophageal reflux reduction system including a plurality of magnets, in accordance with an implementation.

[0115] Fig 15 is a schematic representation of an esophageal hiatus, a right crus and a left crus.

[0116] Fig 16 is a front view of the crus component of Fig 12, shown functionally engaged with a right crus and a left crus.

[0117] Fig 17 is a side perspective view of the stomach component of Fig 5 and the crus component of Fig 12, shown magnetically attracted to each other.

[0118] Fig 18 is a side perspective view of the stomach component of Fig 9 and the crus component of Fig 12, shown magnetically attracted to each other.

[0119] Fig 19 is a side perspective view of the stomach component of Fig 5, shown engaged with an esophagus at a gastroesophageal junction, with a stomach component magnet being positioned posteriorly to a stomach.

[0120] Fig 20 is a side perspective view of the stomach component of Fig 5, shown engaged with an esophagus at a gastroesophageal junction, with a stomach component magnet being positioned posteriorly to a stomach, and of the crus component of Fig 12, shown engaged with a right crus and a left crus.DETAILED DESCRIPTION

[0121] Techniques described herein relate to systems, devices and methods for preventing migration of a gastroesophageal junction of a stomach upwardly through an esophageal hiatus of a diaphragm, and thus, to maintain the gastroesophageal junction within the abdominal cavity.

[0122] The diaphragm is a muscular and membranous structure separating the abdominal cavity and the thoracic cavity. The crura of the diaphragm are two musculotendinous structures connecting the mid-posterior part of the diaphragm to the lumbar vertebrae. The right and left crus converge superiorly in front of the esophagus, with the esophagus and the aorta remaining between the two crus. The right crus attaches to the L1-3 vertebral bodies, while the left crus attaches to the L1-2 vertebral bodies. The right crus is generally longer and wider than the left crus. The right and left crus are joined by a tendinous arch anterior to the aorta, i.e., the median arcuate ligament.

[0123] The esophagus passes through the esophageal hiatus of the diaphragm, at the level of the tenth vertebra T10, up to about 2,5 cm to the left of the midline. The esophageal hiatus is located superoanterior and slightly to the left of the aortic hiatus. The anterior and lateral borders of the esophageal hiatus are formed by the right crus and the left crus of the diaphragm, and the posterior border is formed by the median arcuate ligament. The esophagus hiatus is an oval opening, with fibers of the crura of the diaphragm looping around the esophageal hiatus to form a sling sphincter that prevents gastric contents from refluxing up to the esophagus when intra-abdominal pressure rises during inspiration.

[0124] The esophageal hiatus is formed by the right crus of the diaphragm in the majority of subjects, although variations can exist. Two main variations of the diaphragm crura have been identified, among approximately ten to fifteen variations. In a first variation, both the right and left bundles surrounding the esophagus can originate from the right crus.In a second variation, the right crus and the left crus can form an “8” shape, with the top circle of the “8” forming the esophageal hiatus and thus enclosing the esophagus.

[0125] During inspiration, the intrathoracic pressure becomes more negative and intra-abdominal pressure more positive. A negative pressure in the thorax can promote drawing stomach acid or contents up in the esophagus, if the gastroesophageal junction of the stomach is not maintained below the diaphragm and into the abdominal junction, and thus if the gastroesophageal junction has migrated upwardly through the esophageal hiatus.

[0126] Described herein are gastroesophageal reflux reduction systems for preventing migration of the gastroesophageal junction through the esophageal hiatus. Such systems can include a stomach component and a crus component.

[0127] The stomach component can be engageable with a wall of an esophagus of a patient. More particularly, the stomach component is positionable against an esophageal outer surface of the esophagus of the patient, in a section of the esophagus extending from a gastroesophageal junction and a diaphragm of the patient. In some implementations, the stomach component can thus be located at the gastroesophageal junction itself. The stomach component can include a stomach ring defining an esophagus receiving opening. The esophagus is thus receivable within the esophagus receiving opening, for instance at the approximate level of the gastroesophageal junction. The stomach component also includes a stomach component magnet coupled to the stomach ring. In some implementations, the stomach component magnet can be received within the thickness of the stomach ring, along an arc thereof. In other implementations, the stomach component magnet can be received in an outwardly protruding section, or in a dome-shape protrusion, of the stomach ring. Other configurations are also possible.

[0128] The crus component is fixedly engageable with a right bundle and a left bundle of a diaphragm crus. The crus component comprises a V-shape frame having a right bundle arm and a left bundle arm joined together at a crus component magnet intersection. The right bundle arm is fixedly engageable with the right bundle and the left bundle arm is fixedly engageable with the left bundle. The crus component further comprises a crus component magnet located at the crus component magnet intersection.

[0129] The stomach component magnet and the crus component magnet are configured to be magnetically coupled to each other once brought in sufficiently close proximity. Given that the crus component is fixedly engaged with the right bundle and the left bundle of the diaphragm crus, the crus component remains at a predetermined location onthe diaphragm crus, and consequently, the crus component magnet also remains at the predetermined location. Magnetically coupling the stomach component magnet and the crus component magnet results in the stomach component magnet and thus the stomach component and associated gastroesophageal junction to remain in close proximity to the crus component. By maintaining the gastroesophageal junction in close proximity to the crus component, an upward movement of the gastroesophageal junction can be limited, and the gastroesophageal junction can be prevented from migrating upwardly through the esophageal hiatus. The gastroesophageal junction can thus remain below the diaphragm and into the abdominal cavity, thereby contributing to reducing gastroesophageal reflux.

[0130] It will be appreciated that positional descriptions such as “above”, “below”, “left”, “right”, “inwardly”, “outwardly” and the like should, unless otherwise indicated, be taken in the context of the figures, and should not be considered limiting. The term “outwardly” is intended to refer to a feature that extends toward an exterior side of a reference axis. The term “inwardly” is intended to refer to a feature that extends toward an interior side of a reference axis. It should also be understood that elongated objects described herein are considered to have an implicit “longitudinal axis” and “lateral axis”. The expression “longitudinal axis” is intended to refer to an axis extending along the length of the object, and the expression “lateral axis” is intended to refer to an axis extending perpendicularly to the longitudinal axis, along the width of the object. When referring to a longitudinal direction, it is intended to refer to a direction that extends substantially parallel to the longitudinal axis of the object, encompassing as well as directions that deviate slightly from the longitudinal axis. When referring to a lateral direction, it is intended to refer to a direction that extends substantially parallel to the lateral axis of the object, encompassing as well as directions that deviate slightly from the lateral axis.

[0131] Various implementations and features of the gastroesophageal reflux reduction system will now be described in greater detail in the following paragraphs.General description of the gastroesophageal reflux reduction system

[0132] Fig 1 illustrates a schematic representation of a general overview of the location of a diaphragm, and the location of the stomach and the esophagus relative to the diaphragm, with the stomach being located below the diaphragm. The enlarged portion shown in Fig 1 illustrates more clearly the junction between the stomach and the esophagus, which is called the gastroesophageal junction. In Fig 1 , the stomach and the gastroesophageal junction are located below the diaphragm.

[0133] Fig 2 illustrates a schematic representation of an example of a gastroesophageal junction that has moved upwardly through the esophageal hiatus, such that the gastroesophageal junction is now located above the diaphragm, with the upper part of the stomach bulging into the thoracic cavity. When the gastroesophageal junction moves upwardly through the esophageal hiatus, gastric contents can reflux up to the esophagus, for instance when intra-abdominal pressure rises during inspiration, leading to GERD.

[0134] Figs 3 and 4 are schematic representations of example configurations of the crura of the diaphragm showing the muscular arrangement at the esophageal hiatus. In Fig 3, the right and left bundles surrounding the esophageal hiatus originate from the right crus, with no contribution from the left crus. Nonetheless, there can be various degrees of fibers from the extreme left of the right crus that can cross over and contribute to forming the right margin of the esophageal hiatus, and conversely, there can be fibers from the extreme right of the left crus cross over to the right and contribute to forming the left margin of the esophageal hiatus. In Fig 4, the right crus and the left crus provide a definite contribution for defining the esophageal hiatus. It is to be understood that Figs 3 and 4 are provided as illustrative examples only, and that other presentations of the right and left bundles are possible with various contributions of the right and left crus for defining the esophageal hiatus.Stomach component

[0135] With reference to Figs 5 to 10, a stomach component 10 of a gastroesophageal reflux reduction system for preventing migration of a gastroesophageal junction of a stomach through an esophageal hiatus of a diaphragm is shown. The stomach component 10 includes a stomach ring 12 defining an esophagus receiving opening 14. The stomach ring 12 includes an inward surface 16 and an outward surface 18. The stomach ring also includes a crus component-oriented surface 20 and a stomach-oriented surface 22. The inward surface 16 is configured for placement against the outer surface of an esophagus, in a portion of the esophagus that is located below and the diaphragm and above the stomach. For example, in some implementations, the inward surface 16 of the stomach ring 12 can be configured for placement against the outer surface of gastroesophageal junction. This placement of the stomach ring 12 results in the crus component-oriented surface 20 being oriented toward the right and left bundles of the diaphragm crus, and the stomach-oriented surface 22 being oriented toward the stomach. In some implementations, the stomach ring 12 can be edgeless, such that the transition from the inward surface 16 to the outward surface 18 may be considered as occurring at no definite location. This can occur forinstance when the stomach ring 12 is shaped as a torus. Fig 9 illustrates an example of a stomach component 10 having a stomach ring 12 being shaped as a torus. In such implementations, the inward surface 16 can be considered as corresponding to the surface of the stomach ring 12 that will be in contact with the outer surface of the esophagus. In alternative implementations, the stomach ring 12 may be shaped as shown in Fig 6, with the inward surface 16 and the outward surface 18 being clearly separated by the width of the crus component-oriented surface 20 and the stomach-oriented surface 22. In some implementations, the stomach ring 12 can be shaped as an in-between between the torus shown in Fig 9 and the annular cylinder shown in Fig 5 or Fig 7, for instance.

[0136] The stomach component 10 further includes a stomach component magnet 24 coupled with the stomach ring 12. The stomach component magnet 24 is provided within a given quadrant of the stomach ring 12, which can be referred to as a stomach component magnet quadrant 26. The stomach component magnet quadrant 26 is the portion of the stomach component 10 that will be located posteriorly to the stomach, i.e., at a posterior location, once the stomach component 10 will be implanted around the esophagus. The stomach component magnet 24 is thus located at a selected location around the circumference of the stomach ring 12, such that a selected portion of the stomach component 10 can be magnetically attracted to a crus component magnet of a crus component, as will be discussed in further detail below.

[0137] In some implementations and as illustrated in Fig 9, the stomach component magnet 24 can be received within the thickness of the stomach ring, along an arc thereof. In other words, the stomach ring 12 can have a substantially constant thickness, or width, along an entire circumference thereof, and the stomach component magnet 24 can be received in the thickness of the stomach ring 12 without substantial outward deviation from the ring shape of the stomach ring 12. In other implementations and as illustrated in Figs 5, 6, 8 and 10, the stomach component magnet 24 can be received in an outwardly protruding section 28 of the stomach ring 12. The outwardly protruding section 28 is a section of the stomach ring 12 that has an increased thickness and that extends outwardly to create an increased volume for receiving the stomach magnet 24. In such implementations, the transition to the outwardly protruding section 26 is substantially edgeless and occurs without a significant deviation or bifurcation of the outward surface 18 of the stomach ring 12. In yet other implementations and as illustrated in Fig 7, the stomach component magnet 24 can be received in a dome-shape protrusion 29 of the stomach ring 12. The dome-shape protrusion 29 can protrude outwardly from the outward surface 18 of the stomach ring 12, such that there is a change of direction in the outward surface 18 of the stomach ring 18. In someimplementations, the dome-shape protrusion 29 of the stomach ring 12 can extend from the remainder of stomach ring 12 in a movable fashion. In other words, there can be a slight range of an up-and-down motion and side-to-side motion of the dome-shape protrusion 29, such that the magnetic engagement between the stomach component magnet 24 and the crus component magnet of the crus component can occur even if there is a slight motion of the stomach ring 12, for instance when a patient is swallowing.

[0138] Still referring to Figs 5 to 10, the stomach component magnet 24 includes a crus component magnet engaging surface 30. In some implementations, the crus component magnet engaging surface 30 can be substantially flat. A crus component magnet engaging surface 30 that is substantially flat can facilitate the magnetic engagement with the crus component magnet of the crus component, especially if the crus component magnet of the crus component includes a stomach component magnet engaging surface that is also substantially flat. In some implementations, the crus component magnet engaging surface 30 can be defined by the surface of the stomach component magnet 24 itself. In other implementations, the crus component magnet engaging surface 30 can be provided by the surface of the dome-shape protrusion 29 or the surface of the stomach ring 12, when the stomach component magnet 24 is housed in the dome-shape protrusion 29 or in the stomach ring 12, respectively.

[0139] The stomach component magnet 24 can be any type of suitable magnet composed of the appropriate material. Examples of materials include neodymium magnets (e.g., NdFeB magnets), rare earth magnets, ferromagnetic magnets, and magnets made of a permanent magnetic material such as nickel and cobalt. A magnetically attracted ferrous metal core may take the place of a permanent magnet as the stomach component magnet 24. In some implementations, the magnet or magnets of the stomach component magnet 24 may be made of a magnetic material that is not permanently magnetized, such as soft magnetic alloys, e.g., nickel-iron, silicon iron, iron, iron-cobalt, and ferritic stainless steels.

[0140] In some implementations, the stomach component magnet 24 can be configured such that its magnetic poles are aligned through the thickness of the magnetic material, such that one pole of the magnet of the stomach component magnet 24 can be magnetically coupled with an opposite pole of the crus component magnet when the stomach component magnet 24 and the crus component magnet are brought in sufficiently close proximity, i.e., the pole of the stomach component magnet 24 is opposed to the pole of the crus component magnet located closest to the stomach component magnet engaging surface of the crus component magnet. For instance, when the stomach component magnet24 has a configuration as shown in Figs 5 to 10, the South pole of the stomach component magnet 24 can be located closest to the crus component-oriented surface 20 of the stomach component magnet 24 for magnetically engaging the North pole of the crus component magnet located closest to the stomach component magnet engaging surface, or vice versa. With such a configuration of the stomach component magnet 24 and of the crus component magnet, the South pole of the stomach component magnet 24 can magnetically couple with the North Pole of the crus component magnet of the crus component.

[0141] With reference to Fig 8, in some implementations, the stomach component magnet 24 can include a plurality of magnets 24a. The plurality of magnets 24a can be provided side by side in a linear fashion and received within the thickness of the stomach ring 12 for instance. The plurality of magnets can be provided along an arc of the circumference of the stomach ring 12, within the stomach component magnet quadrant 26. Providing a plurality of magnets 24a can facilitate obtaining a resulting stomach component magnet 24 having a desired disposition and configuration within the thickness of the stomach ring 12, without necessarily having to machine a single magnet with this desired configuration. For instance, the plurality of magnets 24a can be disposed so that the stomach component magnet 24 has a resulting configuration as an arc along the circumference of the stomach ring 12, which can be more easily achieved with multiple smaller magnets than with a single magnet. It is to be noted that although the plurality of magnets 24a shown in Fig 8 includes four magnets, any suitable number of magnets can be used.

[0142] The stomach ring 12 can be made of various materials. In some implementations, the stomach ring 12 can be made of a biocompatible polymeric material or of a metallic material. Examples of suitable polymeric materials include silicones, e.g., polydimethylsiloxane; or a fluoropolymer, e.g., polytetrafluoroethylene, conformable polymers, or any other type of medical implant grade polymers. In some implementations, the stomach component is made of silicone. Examples of metallic materials can include a titanium alloy, cobalt chromium, an austenitic stainless steel, or any other type of medical implant grade metals. The inward surface 16, the outward surface 18, the crus component- oriented surface 20 and the stomach-oriented surface 22 of the stomach ring 12, or at least one of these surfaces, can be smooth and / or lubricious. In some implementations, it may be desirable that the inward surface 16 be smooth and / or lubricious to facilitate the interaction between the outer surface of the esophagus and the inward surface 16 of the stomach ring 12, for instance to reduce friction between the outer surface of the esophagus and the inward surface 16 of the stomach ring 12, and potentially prevent irritation of the outersurface of the esophagus. Although there may or may not be upward and downward movement of the stomach ring 12 along the esophagus, it may also be beneficial that the inward surface 16 be smooth and lubricious such that the esophagus can move slightly within the esophagus receiving opening 14, for instance when the patient is swallowing. In some implementations, the material from which the stomach ring 112 is made can be resilient, and the stomach component 10 can be configured to exert a radial inward force onto the esophagus via the stomach ring 12.

[0143] The material of the stomach ring 12 can also provide a stomach component magnet housing around the stomach component magnet 24 or the plurality of magnets. In such implementations, and as mentioned above, the crus component magnet engaging surface 30 of the stomach component ring 12 can be provided by the stomach component magnet housing itself. In some implementations, the stomach component magnet housing can fully enclose the stomach component magnet 24. Alternatively, the stomach component magnet housing can be absent at the location of the crus component magnet engaging surface 30, such that the crus component magnet engaging surface 30 of the stomach component magnet 24 can be directly exposed and available to magnetically couple the stomach component magnet engaging surface of the crus component magnet of the crus component.

[0144] In some implementations, the stomach ring 12 can be made of a different material at the location of the stomach component magnet 24. In such implementations, the stomach component magnet housing of the stomach component magnet 24 can be made of a first material while the remainder of the stomach ring 12 can be made of a second material, the first material being different than the second material. The first material can be selected according to desirable properties that can facilitate the magnetic engagement of the stomach component magnet 24 with the crus component magnet, for instance. The second material can be selected according to desirable properties that can facilitate a proper engagement of the stomach ring with the esophagus and / or gastroesophageal junction, for instance. These desirable properties can include suppleness and flexibility, among others. In some implementations, the stomach component magnet housing can be made of a biocompatible polymer or a biocompatible metal. In some implementations, the stomach component magnet housing can be made of silicone or polyethylene. In some implementations, the stomach component magnet housing can be made of titanium. In some implementations, the stomach ring 12 can be made of a biocompatible polymer and the stomach component magnet housing can be made of titanium. When the stomach ring 12 is made of a first material and a second material, the stomach component magnet housing canbe integrated with the remainder of the stomach ring 12 so that it forms a resulting integral structure.

[0145] With reference to Fig 10, in some implementations, the stomach ring 12 can include a ring connector 32 enabling the stomach ring 12 to transition from a close configuration to an open configuration. The ring connector 32 can be any type of connector that can connect two portions of the stomach ring 12 together. In some implementations, the ring connector 32 can be provided in a ring connector quadrant 34 located opposite the stomach component magnet quadrant 26. In some implementations and as illustrated in Fig 10, the ring connector 32 can be located diametrically opposite to the stomach component magnet 24. The ring connector 32 can facilitate the placement and implantation of the stomach component 10 around the esophagus, by momentarily enabling the opening of the stomach ring 12 of the stomach component 10. Once the stomach component 10 is implanted at the desired location, the stomach ring 12 of the stomach component 10 can be closed. In some implementations, the presence of the ring connector 32 can enable adjusting an internal diameter of the stomach ring 12. Adjusting the internal diameter of the stomach ring 12 can provide an opportunity for a healthcare provider implanting the stomach component 10 to personalize the fitting of the stomach component 10 onto the esophagus. For instance, the internal diameter of the stomach ring 12 can be adjusted to directly contact the outer surface of the esophagus, the internal diameter of the stomach ring 12 can be adjusted so that there is a predetermined distance between the outer surface of the esophagus and the inward surface 16 of the stomach ring 12, or the internal diameter of the stomach ring 12 can be adjusted to exert a slight inward radial pressure onto the esophagus. It is to be understood that although the ring connector 32 is illustrated in Fig 10 as being present on the stomach ring 12 exemplified in Fig 5, the ring connector 32 can be present on any one of the implementations of the stomach ring 12 as described herein and illustrated , thus including the stomach rings 12 shown in Figs 5 to 9.

[0146] In some implementations, the stomach component 12 can be configured to be fixedly engaged with the outer surface of the wall of the esophagus, such as around the outer surface of the gastroesophageal junction. In order to do so, the stomach ring 12 can be made of a material that will enable a suturing device, such as a needle, to pass through the material with the suturing device subsequently engaging the wall of the esophagus and so on to suture the stomach component 12 at a given location. In other implementations, the stomach component 12 can include features on one or more of the inward surface 16, the outward surface 18, the crus component-oriented surface 20 and the stomach-oriented surface 22 of the stomach ring 12 into which a suturing device can pass through tosubsequently engage the wall of the esophagus to suture the stomach component 12 at a given location. For instance, in some implementations, the stomach ring 12 can define an eye, such as an eye of a needle, into which the suture can be threaded.

[0147] With reference to Fig 11 , another implementation of a stomach component 100 is shown. In this implementation, the stomach component 100 includes multiple stomach ring units 136 provided adjacent to each other in a side-to-side fashion to form a stomach ring 112 that is also closed as with the stomach ring 12 described above. The closing of the stomach ring 112 can be done via a ring connector 132. The features of the stomach ring 112 are similar as those described above in connection with the stomach ring 12. Accordingly, the stomach ring 112 defines an esophagus receiving opening 114, and includes an inward surface 116 and an outward surface 118, a crus-oriented surface 120 and a stomach-oriented surface 122. Adjacent ones of the multiple stomach ring units 136 can be linked together by ring links 138 to provide flexibility to the stomach ring 112. One of the stomach ring units 136 can include a stomach component magnet 124 having a crus component magnet engaging surface 30. The stomach ring unit 136 that includes the stomach component magnet 124 can have a portion of the inward surface 116 that is flat to facilitate the magnetic engagement with the crus component magnet. In some implementations, the ring links 138 can be resilient, and the stomach component 110 can be configured to exert a radial inward force onto the esophagus via the stomach ring 112. It is to be noted that any of the features described above with respect to the implementations of the stomach ring 12 shown in Fig 5 to 10 or described in the application can be applicable to the stomach ring 112 shown in Fig 11. For instance, the stomach ring 12 can be shaped as a torus as shown in Fig 9 and include a dome-shape protrusion as shown in Fig 7, the plurality of magnets 54a can be present in the stomach ring 12 shaped as a torus as shown in Fig 9, and so on.Crus component

[0148] With reference to Figs 12 to 16, a crus component 40 of a gastroesophageal reflux reduction system for preventing migration of a gastroesophageal junction of a stomach through an esophageal hiatus of a diaphragm is shown. The crus component 40 is configured to be fixedly engaged with a right bundle and a left bundle of a diaphragm crus. It is to be understood that when referring to the right bundle and the left bundle of the diaphragm crus, the expression “diaphragm crus” is intended to include both when the esophageal hiatus is defined by the right crus and the left crus and when the esophageal hiatus is defined by the right crus. In order to do so, the crus component 40 includes V-shape frame 42 having a right bundle arm 44 and a left bundle arm 46 joined together at a crus component magnet intersection 48. In some implementations, the crus component magnet intersection 48 is configured for positioning at a lower base of a convergence of the right bundle and the left bundle. The right bundle arm 44 of the V-shape frame 42 is configured to be fixedly engaged with the right bundle of the diaphragm crus, and the left bundle arm 46 of the V-shape frame 42 is configured to be fixedly engaged with the left bundle of the diaphragm crus. In some implementations, the right bundle and the left bundle of the diaphragm crus can originate from a right crus of the diaphragm crus, such as shown in Fig 3 for example, and the right bundle arm and the left bundle arm can be both fixedly engageable with the right crus, on either side of the esophagus. In other implementations, the right bundle and the left bundle originate from a right crus and a left crus of the diaphragm crus respectively, such as shown in Fig 4 for instance, and the right bundle arm and the left bundle arm can be both fixedly engageable with the right crus and the left crus respectively, on either side of the esophagus. In any case, the V-shape frame 42 is configured such that the right bundle arm and the left bundle arm extend on each side of the esophageal hiatus, as illustrated in Figs 15 and 16.

[0149] The V-shape frame 42 of the crus component 40 includes a crus-oriented surface 50 and stomach component-oriented surface 52. The V-shape frame 42 of the crus component 40 also includes a sidewall 54. The crus-oriented surface 50 is configured for placement against the outer surface of a diaphragm crus, resulting in the crus-oriented surface 50 being oriented toward the right and left bundles of the diaphragm crus, and the stomach-component oriented surface 52 is configured to be oriented toward the stomach component 10. In some implementations, the V-shape frame 42 of the crus component 40 can be edgeless, such that the transition from the crus-oriented surface 50 to the sidewall 54 to the stomach component-oriented surface 52 may be considered as occurring at no definite location. This can occur for instance when the right bundle arm 44 and the left bundle arm 46 have a substantially circular cross-section. In alternative implementations, the V-shape frame 42 of the crus component 40 can be shaped as shown in Figs 13 and 17, with the crus-oriented surface 50 and stomach component-oriented surface 52 being separated by the thickness of the V-shape frame 42, i.e., the width of the sidewall 54. In some implementations, the V-shape frame 42 of the crus component 40 can be similar to the implementation shown in Figs 13 and 17, albeit with smoother edges.

[0150] The V-shape frame 42 of the crus component 40 includes a crus component magnet 56 provided at the crus component magnet intersection 48. The crus component magnet 56 is configured to be magnetically engageable with the stomach componentmagnet 24. The crus component magnet 56 is received within the thickness of the crus component magnet intersection 48. The crus component magnet 56 can include a stomach component magnet engaging surface 58 that is substantially flat. In some implementations, the stomach component magnet engaging surface 58 can include a surface roughness to facilitate locking into place the crus component magnet 56 with the stomach component magnet 24 when the crus component magnet engaging surface 30 of the stomach component magnet 24 includes a complimentary surface roughness. Alternatively, a stomach component magnet engaging surface 58 that is substantially flat can facilitate the magnetic engagement with the stomach component magnet 24 of the stomach component 10, especially if the stomach component magnet 24 of the stomach component 10 includes a stomach component magnet engaging surface 30 that is also substantially flat.

[0151] The crus component magnet 56 can be any type of suitable magnet composed of the appropriate material. Examples of materials include neodymium magnets (e.g., NdFeB magnets), rare earth magnets, ferromagnetic magnets, and magnets made of a permanent magnetic material such as nickel and cobalt. A magnetically attracted ferrous metal core may take the place of a permanent magnet as the crus component magnet 56. In some implementations, the magnet or magnets of the crus component magnet 56 may be made of a magnetic material that is not permanently magnetized, such as soft magnetic alloys, e.g., nickel-iron, silicon iron, iron, iron-cobalt, and ferritic stainless steels. In any case, the crus component magnet 56 is configured to be magnetically engaged with the stomach component magnet 24 once the gastroesophageal reflux reduction system is implanted in the abdominal cavity of the patient.

[0152] In some implementations, the crus component magnet 56 can be configured such that its magnetic poles are aligned through the thickness of the magnetic material, such that one pole of the magnet of the crus component magnet 56 can be magnetically coupled with an opposite pole of the stomach component magnet 24 when the stomach component magnet 24 and the crus component magnet 56 are brought in sufficiently close proximity, i.e., the pole of the stomach component magnet 24 is opposed to the pole of the crus component magnet 56 located closest to the stomach component magnet engaging surface 58 of the crus component magnet 56. For instance, the North pole of the crus component magnet 56 can be located along the stomach component-oriented surface 52 for magnetically engaging the South pole of the stomach component magnet 24 of the stomach component 10, or vice versa, as described above. With such a configuration of the stomach component magnet 24 and of the crus component magnet 56, the South pole of the stomachcomponent magnet 24 of the stomach component 10 can magnetically couple with the North Pole of the crus component magnet 56 of the crus component 40.

[0153] With reference to Fig 14, in some implementations, the crus component magnet 56 can include a plurality of magnets 56a. The plurality of magnets 56a can be provided side by side in a linear fashion and received within the thickness of the v-frame 42 of the crus component 40 for instance. In some implementations, the plurality of magnets can be provided to extend within each one of the right bundle arm 44 and the left bundle arm 46. Similarly to the description made above regarding the plurality of magnets for the stomach component magnet 24, providing a plurality of magnets for the crus component magnet 56a can facilitate obtaining a resulting crus component magnet 56 having a desired disposition and configuration within the thickness of the V-shape frame 42, without necessarily having to machine a single magnet with this desired configuration. For instance, the plurality of magnets can be disposed so that the crus component magnet 56 has a resulting V-shape configuration, which can be more easily achieved with multiple smaller magnets than with a single magnet.

[0154] The V-shape frame 42 of the crus component 40 can be made of similar materials as for the stomach ring 12 of the stomach component 10. In some implementations, the V-shape frame 42 can be made of a biocompatible polymeric material or of a metallic material. Examples of suitable polymeric materials include silicones, e.g., polydimethylsiloxane; or a fluoropolymer, e.g., polytetrafluoroethylene, conformable polymers, or any other type of medical implant grade polymers. Examples of metallic materials can include a titanium alloy, cobalt chromium, an austenitic stainless steel, or any other type of medical implant grade metals. The crus-oriented surface 50, the stomach component-oriented surface 52 and the sidewall 54 of the V-shape frame 42 of the crus component 40, or at least some of these surfaces, can be smooth and lubricious. In some implementations, it may be particularly desired that the crus-oriented surface 50 be smooth and lubricious to facilitate the interaction between the outer surface of the diaphragm crus and the crus-oriented surface 50 of the V-shape frame 42, for instance to reduce friction between the outer surface of the diaphragm crus and the crus-oriented surface 50, and potentially prevent irritation of the outer surface of the diaphragm crus.

[0155] The attractive magnetic force between the stomach component magnet 24 and the crus component magnet 56 is sufficiently strong to enable maintaining the magnetic engagement between the stomach component 10 and the crus component 40 at least a majority of the time to prevent the gastroesophageal junction from migrating through theesophageal hiatus. In some implementations, the attractive magnetic force between the stomach component magnet 24 and the crus component magnet 56 can be such that magnetic uncoupling can occur during certain movements of the esophagus. For instance, in some implementations, it may be desirable that during a swallowing of the patient, there can be a brief magnetic uncoupling between the stomach component magnet 24 and the crus component magnet 56, but the attractive magnetic force between the stomach component magnet 24 and the crus component magnet 56 will nonetheless remain sufficient to magnetically recouple the stomach component 10 and the crus component 40 together to achieve the intended purpose of the gastroesophageal reflux reduction system.

[0156] The material of the V-shaped frame 42 can also provide a crus component magnet housing around the crus component magnet 56 or the plurality of magnets. In such implementations, the stomach component magnet engaging surface 52 of the V-shaped frame 42 can be provided by the crus component magnet housing itself. In some implementations, the crus component magnet housing can fully enclose the crus component magnet 56. Alternatively, the crus component magnet housing can be absent at the location of the stomach component magnet engaging surface 52, such that the stomach component magnet engaging surface 52 can be directly exposed and available to magnetically coupled the crus component magnet engaging surface 30 of the stomach component magnet 24 of the stomach component 10. In some implementations, the V-shaped frame 42 can be made of a different material at the location of the crus component magnet 56. In such implementations, the crus component magnet intersection 48 can be made of a first material while the remainder of the V-shape frame 42 can be made of a second material, the first material being different than the second material. The first material can be selected according to desirable properties that can facilitate the magnetic engagement of the crus component magnet 56 with the stomach component magnet 24, for instance. The second material can be selected according to desirable properties that can facilitate a proper engagement of the V-shape frame 42 with the diaphragm crus, for instance. These desirable properties can include suppleness and flexibility, among others. In some implementations, the crus component magnet housing can be made of a biocompatible polymer or a biocompatible metal. In some implementations, the crus component magnet housing can be made of silicone or polyethylene. In some implementations, the crus component magnet housing can be made of titanium. In some implementations, the V-shape frame 42 can be made of a biocompatible polymer and the crus component magnet housing can be made of titanium. When the V-shape frame 42 is made of a first material and a second material, thecrus component magnet housing can be integrated with the remainder of the V-shape frame 42 so that it forms a resulting integral structure.

[0157] In some implementations, the crus component magnet intersection 48 can include a hinge to move the right bundle arm 44 and the left bundle arm 46 of the V-shape frame 42 relative to each other. Moving the right bundle arm 44 and the left bundle arm 46 relative to each other can enable opening or closing the resulting angle between right bundle arm 44 and the left bundle arm 46. Adjusting the angle between right bundle arm 44 and the left bundle arm 46 can provide an opportunity for a healthcare provider implanting the crus component 40 to personalize the fitting of the crus component 40 onto the diaphragm crus. For instance, depending on the size of the esophageal hiatus, the healthcare provider can widen or reduce the angle between right bundle arm 44 and the left bundle arm 46 so that the right bundle arm 44 and the left bundle arm 46 can correctly be engaged with the right bundle and the left bundle, respectively. In some implementations, once the right bundle arm 44 and the left bundle arm 46 are engaged with the right bundle and the left bundle, the right bundle arm 44 and the left bundle arm 46 can be locked into place via a locking mechanism. Alternatively, in other implementations, the right bundle arm 44 and the left bundle arm 46 can be configured to remain movable relative to each other.

[0158] In some implementations, the crus component 40 is configured to be fixedly engaged with the outer surface of the diaphragm crus. In order to do so, the crus component 40 can be made of a material that will enable a suturing device, such as a needle, to pass through the material with the suturing device subsequently engaged the wall of the diaphragm crus and to suture the crus component 40 at a given location. In other implementations, the crus component 40 can include features on one or more of the crus- oriented surface 50, the stomach component-oriented surface 52 and the sidewall 54 of the V-shape frame 42 into which a suturing device can pass through to subsequently engage the wall of the diaphragm crus to suture the crus component 40 at a given location. For instance, in some implementations, the crus component 40 can define an eye, such as an eye of a needle, into which the suture can be threaded.Gastroesophageal reflux reduction system

[0159] Figs 17 to 20 illustrate examples of interactions between the stomach component 10 and the crus component 40.

[0160] In Figs 17 and 18, a magnetic interaction between a stomach component 10 and a crus component 40 is shown. In both examples, the black arrow schematizes theattractive magnetic force involved in bringing the stomach component 10 and the crus component 40 together. In order to do so, the stomach component magnet 24 of the stomach component 10 and the crus component magnet 56 of the crus component 40 are shown as being brought in sufficiently close proximity so that magnetic engagement between the stomach component 10 and the crus component 40 can occur. In Fig 17, the stomach component 10 is shown as slightly turned outwardly to illustrate the crus component magnet engaging surface 30 of the stomach component magnet 24. In Fig 18, the stomach component 10 is shown with a more parallel approach to the crus component 40, with the crus component magnet engaging surface 30 of the stomach component magnet 24 consequently not being visible.

[0161] Fig 19 illustrates an example implementation in which the stomach component 10 is shown engaged with the esophagus, at the level of the gastroesophageal junction. The esophagus is received within the esophagus receiving opening 14, such that the inward surface 16 of the stomach ring 12 is in contact with the outer surface of the esophagus. The stomach ring 12 is positioned such that the stomach component magnet quadrant 26 is located posteriorly to the stomach, i.e., at a posterior location relative to the stomach. With this positioning of the stomach ring 12 and more particularly of the stomach component magnet quadrant 26 posteriorly to the stomach, the crus component magnet engaging surface 30 of the stomach component magnet 24 is oriented toward the diaphragm crus, and eventually the stomach component magnet engaging surface 58 of the crus component magnet 56.

[0162] Fig 20 illustrates an example implementation where the stomach component 10 is shown engaged with the esophagus, at the level of the gastroesophageal junction, as shown in Fig 19. In Fig 20, a crus component 40 is also shown, the crus component 40 being engaged with the diaphragm crus. More particularly, the right bundle arm 44 of the V- shape frame 42 is shown fixedly engaged with the right bundle of the diaphragm crus, and the left bundle arm (not shown) of the V-shape frame 42 is fixedly engaged with the left bundle of the diaphragm crus. With this placement of the stomach component 10 and the crus component 40, the crus component magnet engaging surface 30 of the stomach component magnet 24 is oriented toward the stomach component magnet engaging surface 58 of the crus component magnet 56, so that there can be a magnetic coupling between the stomach component magnet 24 and the crus component magnet 56.Method for implanting a astroesopha eal reflux reduction system

[0163] A method for implanting a system for preventing migration of a gastroesophageal junction of a stomach through an esophageal hiatus of a diaphragm of a patient as described herein will now be described in further detail.

[0164] The method includes positioning a stomach component against an esophageal outer surface of a gastroesophageal junction of a stomach such that the gastroesophageal junction passes through an esophagus receiving opening of a stomach ring of the stomach component. The stomach component is thus placed around the esophagus, for instance at the level of the gastroesophageal junction, so that an inward surface of the stomach ring of the stomach component can be placed against the esophageal outer surface of the gastroesophageal junction.

[0165] In some implementations, positioning the stomach component against the esophageal outer surface can be performed surgically. In other implementations, positioning the stomach component against the esophageal outer surface can be performed laparoscopically. Other suitable techniques can be used a determined suitable by a healthcare provider.

[0166] Once the stomach component is positioned against the esophageal outer surface of the gastroesophageal junction, or as part of this positioning, a stomach component magnet of the stomach component is oriented so as to be placed in a posterior location relative to the stomach such that the stomach component magnet faces a diaphragm crus of the patient.

[0167] Before or after the positioning of the stomach component and the orienting of the stomach component magnet in the posterior location, a crus component is fixedly engaged with a right bundle and a left bundle of the diaphragm crus. Fixedly engaging the crus component with the right bundle and the left bundle of the diaphragm crus can include engaging a right bundle arm of a V-shape frame of the crus component with a right bundle of the diaphragm crus, and engaging a left bundle arm of the V-shape frame of the crus component with a left bundle of the diaphragm crus. With the engagement of the right bundle arm with the right bundle and the left bundle arm with the left bundle, the right bundle arm and the left bundle arm extend on each side of an esophageal hiatus, and thus extend on each side of the esophagus. The right bundle arm and the left bundle arm are joined together at a crus component magnet intersection, in an inferior portion of the V-shapeframe. The crus component includes a crus component magnet provided at the crus component magnet intersection.

[0168] In some implementations, the right bundle and the left bundle of the diaphragm crus originate from a right crus of the diaphragm crus, and engaging the right bundle arm and the left bundle arm with the right bundle and the left bundle is performed by engaging the right bundle arm and the left bundle arm with the right crus, on either side of the gastroesophageal junction.

[0169] In other implementations, the right bundle and the left bundle of the diaphragm crus originate from a right crus and a left crus of the diaphragm crus, respectively, and engaging the right bundle arm and the left bundle arm with the right bundle and the left bundle is performed by engaging the right bundle arm and the left bundle arm with the right crus and the left crus respectively, on either side of the gastroesophageal junction.

[0170] The above details are provided to take into consideration possible configurations that an esophageal hiatus can have, depending on the patient. These examples should not be construed as being restrictive. In any case, the V-shape frame of the crus component is configured to extend on each side of the esophageal hiatus so that the V-shape frame consequently extends on each side of the esophagus.

[0171] In some implementations, when the right bundle arm 44 can be moved relative to the left bundle arm 46, fixedly engaging a crus component with a right bundle and a left bundle of the diaphragm crus can include opening or closing the resulting angle between right bundle arm and the left bundle arm to achieve a desired angle.

[0172] Then, the crus component magnet of the crus component is oriented in an anterior location relative to the diaphragm crus such that the crus component magnet faces the stomach. Orienting the crus component magnet of the crus component in the anterior location relative to the diaphragm crus such that the crus component magnet faces the stomach is performed to enable a crus component magnet engaging surface of the stomach component magnet to face a stomach component magnet engaging surface of the crus component magnet, as exemplified in Figs 17 and 18.

[0173] In some implementations, fixedly engaging the crus component with the right bundle and the left bundle of the diaphragm crus can be performed surgically. In otherimplementations, fixedly engaging the crus component with the right bundle and the left bundle of the diaphragm crus can be laparoscopically.

[0174] In some implementations, fixedly engaging the crus component with the right bundle and the left bundle of the diaphragm crus can include suturing the right bundle arm to the right bundle and suturing the left bundle arm to the left bundle.

[0175] Once the crus component magnet engaging surface of the stomach component magnet faces the stomach component magnet engaging surface of the crus component magnet, the stomach component magnet and the crus component magnet can be brought in sufficiently close proximity to be magnetically coupled to each other.

[0176] In some implementations, depending on the configuration of the stomach component, the method can further include exerting a radial inward force onto the gastroesophageal junction using the stomach ring. In some implementations, exerting a radial inward force can contribute to maintaining the stomach component at the desired location, and potentially contribute to reducing reflux from the stomach to the esophagus as well.

[0177] In some implementations, the method can further include fixedly engaging the stomach component with a wall of the esophagus. In some implementations, fixedly engaging the stomach component with the wall of the esophagus can include suturing the stomach component to the wall of the esophagus.

[0178] In some implementations, fixedly engaging the stomach component with the wall of the esophagus can include using gastro-gastric imbrication sutures, also referred to as gastro-gastric tunneling sutures, to contribute to securing the stomach component to the wall of the esophagus, and potentially a part of the stomach wall as well. In some implementations, the gastro-gastric imbrication sutures can be used to create a plication over at least a portion of the stomach component. In such implementations, part of the stomach wall can be used to contribute to the plication, which again can contribute to avoiding slippage of the stomach component. In some implementations, the stomach component can be fixedly engaged with the wall of the stomach, as an alternative to being fixedly engaged with the wall of the esophagus.

[0179] When the stomach component and the crus component are fixedly engaged with the wall of the esophagus and the crus component, respectively, this can help in controlling the movement of the esophagus such that the gastroesophageal junction remainsbelow the diaphragm, instead of the esophagus being allowed to move within the esophagus receiving opening of the stomach ring.

[0180] It is to be understood that although the illustrated examples related to the implantation of the system for preventing migration of the gastroesophageal junction are shown in the context of a “normal” anatomy of the digestive system of the patient, the system as described herein can also be implanted in a patient that has been subjected to another procedure involving the digestive system, such as bariatric procedure, including for instance a sleeve gastrectomy, a gastric bypass, a complete or a partial esophagectomy, among others.

[0181] To provide a more concise description, some of the quantitative expressions provided herein are qualified with the term "about". It will be understood that whether the term "about" is used explicitly or not, every quantity recited herein is meant to refer to an actual given value, and it is also meant to refer to the approximation to such given value that would reasonably be inferred by a person of ordinary skill in the art, including approximations due to the experimental and / or measurement conditions for such given value.

[0182] Several alternative embodiments and examples have been described and illustrated herein. The embodiments of the invention described above are intended to be exemplary only. A person of ordinary skill in the art would appreciate the features of the individual embodiments, and the possible combinations and variations of the components. A person of ordinary skill in the art would further appreciate that any of the embodiments could be provided in any combination with the other embodiments disclosed herein. It is understood that the invention may be embodied in other specific forms without departing from the central characteristics thereof. The present examples and embodiments, therefore, are to be considered in all respects as illustrative and not restrictive, and the invention is not to be limited to the details given herein. Accordingly, while the specific embodiments have been illustrated and described, numerous modifications come to mind. The scope of the invention is therefore intended to be limited solely by the scope of the appended claims.

Claims

CLAIMS1. A gastroesophageal reflux reduction system for preventing migration of a gastroesophageal junction of a stomach through an esophageal hiatus of a diaphragm, the system comprising: a stomach component engageable with a wall of an esophagus of a patient, the stomach component being positionable against an esophageal outer surface of the esophagus, in a section of the esophagus extending from the gastroesophageal junction and the diaphragm, the stomach component comprising: a stomach ring comprising an inward surface defining an esophagus receiving opening; and a stomach component magnet coupled with the stomach ring; a crus component fixedly engageable with a right bundle and a left bundle of a diaphragm crus, the crus component comprising: a V-shape frame having a right bundle arm and a left bundle arm joined together at a crus component magnet intersection; and a crus component magnet located at the crus component magnet intersection and configured to be magnetically coupled to the stomach component magnet once brought in sufficiently close proximity; wherein when the stomach component magnet and the crus component magnet are magnetically coupled to each other, an upward movement of the gastroesophageal junction is limited, and the gastroesophageal junction is prevented from migrating through the esophageal hiatus.

2. The system of claim 1 , wherein the stomach component magnet is received within a thickness of the stomach ring.

3. The system of claim 2, wherein the stomach ring comprises an outwardly protruding section configured to receive the stomach component magnet.

4. The system of claim 1 , wherein the stomach ring comprises a dome-shape protrusion configured to receive the stomach component magnet.

5. The system of any one of claims 1 to 4, wherein the stomach ring is shaped as a torus.

6. The system of any one of claims 1 to 5, wherein the crus component magnet intersection is configured for positioning at a lower base of a convergence of the right bundle and the left bundle.

7. The system of any one of claims 1 to 6, wherein the stomach component magnet is configured for positioning at a posterior location around the esophagus.

8. The system of any one of claims 1 to 7, wherein the stomach component is positionable at the gastroesophageal junction.

9. The system of any one of claims 1 to 8, wherein the right bundle and the left bundle originate from a right crus of the diaphragm crus, such that the right bundle arm and the left bundle arm are both fixedly engageable with the right crus, on either side of the esophagus.

10. The system of any one of claims 1 to 8, wherein the right bundle and the left bundle originate from a right crus and a left crus of the diaphragm crus respectively, such that the right bundle arm and the left bundle arm are fixedly engageable with the right crus and the left crus respectively, on either side of the esophagus.

11. The system of any one of claims 1 to 10, wherein the stomach component further comprises a ring connector enabling the stomach ring to transition from a close configuration to an open configuration.

12. The system of claim 11 , wherein the ring connector is provided in a ring connector quadrant located opposite a stomach component magnet quadrant in which the stomach component magnet is located.

13. The system of claim 11 or 12, wherein the ring connector is located diametrically opposite to the stomach component magnet.

14. The system of any one of claims 1 to 13, wherein the stomach component is made of a stomach component material comprising a biocompatible polymer.

15. The system of claim 14, wherein the stomach component material comprises silicone.

16. The system of claim 14, wherein the stomach component material comprises polyethylene.

17. The system of any one of claims 1 to 16, wherein the stomach component magnet comprises a crus component magnet engaging surface that is substantially flat.

18. The system of any one of claims 1 to 17, wherein the crus component magnet comprises a stomach component magnet engaging surface that is substantially flat.

19. The system of any one of claims 1 to 16, wherein the stomach component magnet comprises a crus component magnet engaging surface having a surface roughness.

20. The system of any one of claims 1 to 17, wherein the crus component magnet comprises a stomach component magnet engaging surface having a complementary surface roughness to that of the crus component magnet engaging surface of the stomach component magnet.

21. The system of any one of claims 1 to 16, wherein the stomach component magnet is enclosed in a stomach component magnet housing made of a stomach component magnet housing material.

22. The system of claim 21 , wherein the stomach component magnet housing fully encloses the stomach component magnet.

23. The system of claim 22, wherein the stomach component magnet housing comprises a crus component magnet engaging surface that is substantially flat.

24. The system of claim 23, wherein the crus component magnet comprises a stomach component magnet engaging surface that is substantially flat.

25. The system of claim 22, wherein the stomach component magnet housing comprises a crus component magnet engaging surface having a surface roughness.

26. The system of claim 25, wherein the crus component magnet comprises a stomach component magnet engaging surface having a complementary surface roughness to that of the crus component magnet engaging surface of the stomach component magnet housing.

27. The system of any one of claims 21 to 26, wherein the stomach component magnet housing material comprises titanium.

28. The system of any one of claims 1 to 27, wherein the crus component is made of a crus component material comprising a biocompatible polymer.

29. The system of claim 28, wherein the crus component material comprises silicone.

30. The system of claim 28, wherein the crus component material comprises polyethylene.

31. The system of any one of claims 1 to 26, wherein an attractive magnetic force between the stomach component magnet and the crus component magnet is selected such that the stomach component magnet and the crus component magnet are alternately magnetically engaged and magnetically disengaged in reaction to swallowing movements once the stomach component and the crus component are implanted around the esophagus and at the diaphragm crus, respectively.

32. The system of any one of claims 1 to 31 , wherein the stomach component is fixedly engageable with the wall of the esophagus.

33. The system of any one of claims 1 to 32, wherein the crus component comprises a hinge at the crus component magnet intersection to move the right bundle arm and the left bundle arm of the V-shape frame relative to each other.

34. The system of any one of claims 1 to 33, wherein the stomach component magnet comprises a plurality of magnets.

35. The system of any one of claims 1 to 34, wherein the crus component magnet comprises a plurality of magnets.

36. The system of claim 1 , wherein the stomach ring comprises a multiple stomach ring units provided adjacent to each other in a side-to-side fashion.

37. The system of claim 36, wherein the stomach component further comprises a ring connector enabling the stomach ring to transition from a close configuration to an open configuration.

38. A stomach component engageable with a wall of an esophagus of a patient as part of a gastroesophageal reflux reduction system for preventing migration of a gastroesophageal junction of a stomach through an esophageal hiatus of a diaphragm, the stomach component comprising: a stomach ring comprising an inward surface defining an esophagus receiving opening; and a stomach component magnet coupled with the stomach ring; wherein the stomach component is positionable against an esophageal outer surface of the esophagus, in a section of the esophagus extending from the gastroesophageal junction and the diaphragm; and wherein the stomach component magnet is configured to be magnetically attracted to a crus component magnet of a crus component to limit an upward movement of the gastroesophageal junction and prevent the gastroesophageal junction from migrating through the esophageal hiatus.

39. The stomach component of claim 38, wherein the stomach component magnet is received within a thickness of the stomach ring.

40. The stomach component of claim 39, wherein the stomach ring comprises an outwardly protruding section configured to receive the stomach component magnet.

41. The stomach component of claim 38, wherein the stomach ring comprises a domeshape protrusion configured to receive the stomach component magnet.

42. The stomach component of any one of claims 38 to 41 , wherein the stomach ring is shaped as a torus.

43. The stomach component of any one of claims 38 to 42, wherein the stomach component magnet is configured for positioning at a posterior location around the esophagus.

44. The stomach component of any one of claims 38 to 43, wherein the stomach component is positionable at the gastroesophageal junction.

45. The stomach component of any one of claims 38 to 44, wherein the stomach component further comprises a ring connector enabling the stomach ring to transition from a close configuration to an open configuration.

46. The stomach component of claim 45, wherein the ring connector is provided in a ring connector quadrant located opposite a stomach component magnet quadrant in which the stomach component magnet is located.

47. The stomach component of claim 45 or 46, wherein the ring connector is located diametrically opposite to the stomach component magnet.

48. The stomach component of any one of claims 38 to 47, wherein the stomach component is made of a stomach component material comprising a biocompatible polymer.

49. The stomach component of claim 48, wherein the stomach component material comprises silicone.

50. The stomach component of claim 48, wherein the stomach component material comprises polyethylene.

51. The stomach component of any one of claims 38 to 50, wherein the stomach component magnet comprises a crus component magnet engaging surface that is substantially flat.

52. The stomach component of any one of claims 38 to 50, wherein the stomach component magnet comprises a crus component magnet engaging surface having a surface roughness.

53. The stomach component of any one of claims 38 to 50, wherein the stomach component magnet is enclosed in a stomach component magnet housing made of a stomach component magnet housing material.

54. The stomach component of claim 53, wherein the stomach component magnet housing fully encloses the stomach component magnet.

55. The stomach component of claim 53, wherein the stomach component magnet housing comprises a crus component magnet engaging surface that is substantially flat.

56. The stomach component of claim 53, wherein the stomach component magnet housing comprises a crus component magnet engaging surface having a surface roughness.

57. The stomach component of any one of claims 53 to 56, wherein the stomach component magnet housing material comprises titanium.

58. The stomach component of any one of claims 38 to 57, wherein the stomach component is fixedly engageable with the wall of the esophagus.

59. The stomach component of any one of claims 38 to 58, wherein the stomach component magnet comprises a plurality of magnets.

60. The stomach component of claim 38, wherein the stomach ring comprises a multiple stomach ring units provided adjacent to each other in a side-to-side fashion.

61. The stomach component of claim 60, wherein the stomach component further comprises a ring connector enabling the stomach ring to transition from a close configuration to an open configuration.

62. A crus component of a gastroesophageal reflux reduction system for preventing migration of a gastroesophageal junction of a stomach through an esophageal hiatus of a diaphragm, the crus component comprising: a crus component fixedly engageable with a right bundle and a left bundle of a diaphragm crus, the crus component comprising: a V-shape frame having a right bundle arm and a left bundle arm joined together at a crus component magnet intersection; and a crus component magnet located at the crus component magnet intersection and configured to be magnetically coupled to a stomach component magnet of a stomach component once brought in sufficiently close proximity; wherein when the crus component magnet and the stomach component magnet are magnetically coupled to each other, an upward movement of the gastroesophageal junction is limited, and the gastroesophageal junction is prevented from migrating through the esophageal hiatus.

63. The crus component of claim 62, wherein the crus component magnet intersection is configured for positioning at a lower base of a convergence of the right bundle and the left bundle.

64. The crus component of claim 62 or 63, wherein the right bundle and the left bundle originate from a right crus of the diaphragm crus, such that the right bundle arm and the left bundle arm are both fixedly engageable with the right crus, on either side of the esophagus.

65. The crus component of claim 62 or 63, wherein the right bundle and the left bundle originate from a right crus and a left crus of the diaphragm crus respectively, such that the right bundle arm and the left bundle arm are fixedly engageable with the right crus and the left crus respectively, on either side of the esophagus.

66. The crus component of any one of claims 62 to 65, wherein the crus component magnet comprises a stomach component magnet engaging surface that is substantially flat.

67. The crus component of any one of claims 62 to 65, wherein the crus component magnet comprises a stomach component magnet engaging surface having a complementary surface roughness to that of a crus component magnet engaging surface of the stomach component magnet.

68. The crus component of any one of claims 62 to 67, wherein the crus component is made of a crus component material comprising a biocompatible polymer.

69. The crus component of claim 68, wherein the crus component material comprises silicone.

70. The crus component of claim 68, wherein the crus component material comprises polyethylene.

71. The crus component of any one of claims 62 to 70, wherein the crus component comprises a hinge at the crus component magnet intersection to move the right bundle arm and the left bundle arm of the V-shape frame relative to each other.

72. The crus component of any one of claims 62 to 71 , wherein the crus component magnet comprises a plurality of magnets.

73. A method for preventing migration of a gastroesophageal junction of a stomach through an esophageal hiatus of a diaphragm, the method comprising: positioning a stomach component against an esophageal outer surface of an esophagus of a patient, in a section of the esophagus extending from the gastroesophageal junction and the diaphragm, such that the esophagus passes through an esophagus receiving opening of a stomach ring of the stomach component; orienting a stomach component magnet of the stomach component in a posterior location relative to the stomach such that the stomach component magnet faces a diaphragm crus; fixedly engaging a crus component with a right bundle and a left bundle of the diaphragm crus, comprising: engaging a right bundle arm of a V-shape frame of the crus component with a right bundle of the diaphragm crus; engaging a left bundle arm of the V-shape frame of the crus component with a left bundle of the diaphragm crus, the right bundle arm and the left bundle arm being joined together at a crus component magnet intersection; orienting a crus component magnet of the crus component in an anterior location relative to the diaphragm crus such that the crus component magnet faces the stomach, the crus component magnet being located at the crus component magnet intersection; magnetically coupling the stomach component magnet and the crus component magnet.

74. The method of claim 73, wherein the right bundle and the left bundle originate from a right crus of the diaphragm crus, and engaging the right bundle arm and the left bundle arm with the right bundle and the left is performed by engaging the right bundle arm and the left bundle arm with the right crus, on either side of the esophagus.

75. The method of claim 73, wherein the right bundle and the left bundle originate from a right crus and a left crus of the diaphragm crus respectively, and engaging theright bundle arm and the left bundle arm with the right bundle and the left is performed by engaging the right bundle arm and the left bundle arm with the right crus and the left crus respectively, on either side of the esophagus.

76. The method of any one of claims 73 to 75, wherein positioning the stomach component against the esophageal outer surface is performed surgically or laparoscopically.

77. The method of any one of claims 73 to 76, wherein fixedly engaging the crus component with the right bundle and the left bundle of the diaphragm crus is performed surgically or laparoscopically.

78. The method of any one of claims 73 to 77, wherein fixedly engaging the crus component with the right bundle and the left bundle of the diaphragm crus comprises suturing the right bundle arm to the right bundle and / or suturing the left bundle arm to the left bundle.

79. The method of any one of claims 73 to 78, further comprising exerting a radial inward force onto the esophagus via the stomach ring.

80. The method of any one of claims 73 to 79, further comprising fixedly engaging the stomach component with the wall of the esophagus.81 . The method of claim 80, wherein fixedly engaging the stomach component with the wall of the esophagus comprises suturing the stomach component to the wall of the esophagus.

82. A method for preventing migration of a gastroesophageal junction of a stomach through an esophageal hiatus of a diaphragm, the method comprising: positioning a stomach component against an esophageal outer surface of an esophagus of a patient, in a section of the esophagus extending from the gastroesophageal junction and the diaphragm, such that the esophagus passes through an esophagus receiving opening of a stomach ring of the stomach component, the stomach component comprising a stomach component magnet; fixedly engaging a crus component with a right bundle and a left bundle of a diaphragm crus, the crus component comprising a crus component magnet;magnetically coupling the stomach component magnet and the crus component magnet.

83. The method of claim 82, wherein positioning the stomach component against the esophageal outer surface is performed surgically or laparoscopically.

84. The method of claim 82 or 83, wherein fixedly engaging the crus component with the right bundle and the left bundle of the diaphragm crus is performed surgically or laparoscopically.

85. The method of any one of claims 82 to 84, wherein fixedly engaging the crus component with the right bundle and the left bundle of the diaphragm crus comprises suturing the crus component with the right bundle and / or the left bundle.

86. The method of any one of claims 82 to 85, further comprising exerting a radial inward force onto the esophagus via the stomach ring.

87. The method of any one of claims 82 to 86, further comprising fixedly engaging the stomach component with the wall of the esophagus.

88. The method of claim 87, wherein fixedly engaging the stomach component with the wall of the esophagus comprises suturing the stomach component to the wall of the esophagus.

89. The system of any one of claims 1 to 37, further comprising one or more features as defined and / or illustrated herein.

90. The stomach component of any one of claims 38 to 61 , further comprising one or more features as defined and / or illustrated herein.91 . The crus component of any one of claims 62 to 72, further comprising one or more features as defined and / or illustrated herein.

92. The method of any one of claims 73 to 88, further comprising one or more features as defined and / or illustrated herein.

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