Treatment of gastroesophageal reflux disease

Abstract

An implantable medical device for treating reflux disease includes a movement restriction device configured to be anchored to the stomach wall to prevent movement of the lower esophageal sphincter relative to the thoracic diaphragm. The movement restriction device includes a first portion, a second portion, and a first distance element. The first and second portions are configured to be connected to each other to form at least a portion of a functional movement restriction device. The first and second portions are detachable from each other to allow the first and second portions to pass independently through the gastrointestinal tract, and the first distance element is configured to form a space between the first and second portions, the space being configured to allow fibrous tissue ingrowth between the first and second portions.

Description

[Technical Field]

[0001] The present concepts relate generally to internal implants, and more particularly to medical implants for treating gastroesophageal reflux disease (GERD). [Background technology]

[0002] Gastroesophageal reflux disease (GERD), or reflux esophagitis, is a condition in which the lining of the esophagus is damaged by the repeated reflux of acid. Treatment for GERD includes both medical and surgical options. One example of a surgical procedure is the Nissen procedure, which involves wrapping the upper curve of the stomach (fundus) around the lower esophageal sphincter (LES), strengthening the sphincter and preventing acid reflux, as well as repairing a hiatal hernia. However, this procedure carries the risk of narrowing the passageway for food, making swallowing difficult.

[0003] Another example is the Anglechick prosthesis, a horseshoe-shaped device placed around the esophagus above the cardia. Its purpose is to prevent the cardia from sliding upward into the thoracic cavity. However, this device is associated with numerous complications, including migration through the esophagus and esophageal injury. Furthermore, the body tends to react to medical implants, both because they are foreign bodies and because they mechanically interact with bodily tissues. When tissues engage with an implant for extended periods or are exposed to pressure from the implant, cells can be deprived of oxygen and nutrients, potentially leading to tissue deterioration, atrophy, and ultimately necrosis.

[0004] Therefore, it would be beneficial to provide a more efficient and / or less damaging technique for treating GERD. Summary of the Invention [Problem to be solved by the invention]

[0005] It is an object of the present inventive concept to overcome or at least mitigate at least some of the drawbacks associated with the treatment of GERD mentioned above. Further and / or alternative objects will be appreciated from the following. [Means for solving the problem]

[0006] A method of treating reflux disease in a human patient by implanting a movement restriction device is provided. The movement restriction device is positioned to restrict movement of the cardia of the patient's stomach toward the diaphragm to prevent the cardia from sliding through an opening in the diaphragm and into the patient's thoracic cavity. The method includes attaching a fundus of the patient's stomach to the patient's esophagus at a first location, attaching the fundus of the patient's stomach to the patient's esophagus at a second location a craniocaudal distance from the first location, and positioning the movement restriction device between the first and second locations, such that the movement restriction device is secured in the craniocaudal direction by attachments between the fundus and the esophagus at the first and second locations.

[0007] According to one embodiment, the step of attaching the patient's fundus to the patient's esophagus in a second position precedes the step of positioning the movement restriction device between the first and second positions.

[0008] According to one embodiment, at least one of the steps of attaching the patient's gastric fundus to the patient's esophagus at a first location and attaching the patient's gastric fundus to the patient's esophagus at a second location includes suturing or stapling the gastric fundus to the esophagus.

[0009] According to one embodiment, there is a step of attaching the patient's stomach fundus to the patient's esophagus in a first position, and a step of dissecting the patient's stomach prior to the step of attaching the patient's stomach fundus to the patient's esophagus in a second position.

[0010] According to one embodiment, at least one of the steps of attaching the patient's gastric fundus to the patient's esophagus at a first location and attaching the patient's gastric fundus to the patient's esophagus at a second location is performed using a translaminar instrument configured to be inserted through the patient's esophagus.

[0011] According to one embodiment, the step of positioning the movement restriction device between the first position and the second position is performed using an abdominal instrument configured to enter the patient's abdomen through an incision made in the patient's skin.

[0012] At least one of the steps of attaching the patient's gastric fundus to the patient's esophagus at a first location and attaching the patient's gastric fundus to the patient's esophagus at a second location can be performed using an abdominal instrument configured to enter the patient's abdomen through an incision made in the patient's skin.

[0013] The step of attaching the fundus of the patient's stomach to the patient's esophagus at a first position can include attaching the fundus of the patient's stomach to the patient's esophagus at a distance greater than 5 mm, greater than 10 mm, greater than 20 mm, or greater than 30 mm from the angle of His.

[0014] Positioning the movement restriction device between the first position and the second position can include positioning the center of mass of the movement restriction device in a plane extending perpendicular to the cranio-coccygeal direction at a distance greater than 20 mm or greater than 30 mm from the His angle.

[0015] The step of positioning the movement restriction device between the first position and the second position may include positioning an upper end point of the movement restriction device at a distance of more than 5 mm, or more than 10 mm, from an upper end point of the cardia in a plane extending perpendicular to the cranio-coccygeal direction.

[0016] The step of positioning the movement restriction device between the first position and the second position may include positioning the center of mass of the movement restriction device at a distance greater than 1 mm, greater than 5 mm, or greater than 10 mm from the uppermost point of the cardia in a plane extending perpendicular to the cranio-coccygeal direction.

[0017] The movement restriction device may have a rounded or spherical shape in any of the embodiments herein.

[0018] The step of positioning the movement restriction device may include placing the movement restriction device to surround at least one-third of the esophagus in a plane extending perpendicular to the cranial-coccygeal direction, or placing the movement restriction device to surround at least one-half of the esophagus in a plane extending perpendicular to the cranial-coccygeal direction, or placing the movement restriction device to surround at least two-thirds of the esophagus in a plane perpendicular to the cranial-coccygeal direction, or placing the movement restriction device to surround the esophagus in a plane perpendicular to the cranial-coccygeal direction.

[0019] The step of positioning the movement restriction device may include positioning the movement restriction device with a curved outer surface such that the curved outer surface faces the esophagus. The curved outer surface may have a radius of curvature that corresponds to or exceeds the radius of curvature of the esophagus.

[0020] The step of positioning the movement restriction device may include positioning the movement restriction device including an electrode arrangement configured to electrically stimulate muscle tissue in the fundus and / or serosal portion of the organ furthest from the opening to improve the long-term implant condition of the movement restriction device.

[0021] In any embodiment, the method may include implanting an implantable energy source configured to power the electrodes. The implantable energy source may be located internal to the movement restriction device or may be located subcutaneously. The method may further include implanting an implantable energy source electrically connected to the electrodes and an implantable charger configured to allow charging of the implantable energy source by an external energy source.

[0022] The method may further include implanting a controller configured to be operably connected to the electrode arrangement to control electrical stimulation of the muscle tissue. The controller may be configured to control the electrical stimulation such that the muscle tissue is stimulated with a series of electrical pulses PL1, PL2, PL3, and PL4. The electrical stimulation signal may include a pulse frequency of 0.15-0.25 Hz, a pulse duration of 20-30 ms, and a pulse amplitude of 3-10 mA. The controller may comprise a wireless remote control.

[0023] According to one embodiment, positioning the movement restriction device includes positioning the movement restriction device having a contracted state to prevent the passage of fluid from the stomach to the esophagus and an expanded state to allow the passage of food to the stomach in response to the patient swallowing. Positioning the movement restriction device may include positioning the movement restriction device configured to exert an enveloping pressure on the esophagus in the contracted state.

[0024] According to one embodiment, the step of positioning the movement restriction device includes positioning the movement restriction device including at least one attractor for resiliently attracting adjacent portions of the movement restriction device to generate an enveloping pressure. The attractor may include an elastic element or at least two mutually attracting magnets. The device may further include a link connecting a first magnet and a second magnet of the at least two magnets to each other.

[0025] The step of positioning the travel limiting device may comprise positioning a non-adjustable travel limiting device, or alternatively, the step of positioning the travel limiting device may comprise positioning a travel limiting device having an adjustable volume.

[0026] An apparatus for treating reflux disease in a human patient is also provided. The apparatus includes an implantable migration restriction device shaped and sized to rest against a fundus wall of the patient's stomach, the migration restriction device being implanted at a position between the patient's diaphragm and a portion of the fundus wall to restrict migration of the patient's stomach cardia toward the diaphragm and prevent the cardia from sliding through an opening in the diaphragm and into the patient's thoracic cavity. The apparatus further includes a first electrode arrangement configured to engage and electrically stimulate muscle tissue in the fundus wall to mobilize the muscle tissue and improve long-term implantation conditions of the migration restriction device, and a second electrode arrangement configured to engage and electrically stimulate a cardiac sphincter to cause contraction of the cardiac sphincter.

[0027] According to one embodiment, a first electrode arrangement is disposed on an outer surface of the movement restriction device. The first electrode arrangement may include a plurality of electrode elements, each configured to engage and electrically stimulate muscle tissue.

[0028] The first electrode arrangement may include a coiled wire to increase the contact area between the first electrode arrangement and the muscle tissue and enable the first electrode arrangement to follow the contraction and relaxation of the muscle tissue.

[0029] At least one of the first and second electrode configurations may include an exposed electrode portion configured to form a metal-tissue interface with muscle tissue, such that faradaic charge transfer across the interface is the predominant charge transfer mechanism.

[0030] At least one of the first and second electrode arrangements may include an electrode portion at least partially covered by a dielectric material configured to form a dielectric-tissue interface with muscle tissue, thereby reducing the faradaic portion of charge transfer mechanisms across the interface.

[0031] According to one embodiment, the second electrode arrangement includes at least two electrode elements configured to be placed on opposite sides of the cardiac sphincter.

[0032] The device may further include a holder configured to support at least two electrode elements on opposite sides of the cardiac sphincter.

[0033] According to one embodiment, the device may further comprise an implantable energy source configured to power the electrodes. The implantable energy source may be located internal to the movement restriction device or external to the movement restriction device, such as subcutaneously. The implantable energy source may include a primary cell and / or a secondary cell.

[0034] The device according to any of the above embodiments may further include a controller configured to be operably connected to the electrode arrangement to control electrical stimulation of muscle tissue. The controller may be configured to control the electrical stimulation such that the muscle tissue is stimulated with a series of electrical pulses PL1, PL2, PL3, PL4. The controller may be configured to control the electrical stimulation such that a pulse of a first polarity is followed by a pulse of a second, opposite polarity.

[0035] According to one embodiment, the controller is configured to generate a pulsed electrical stimulation signal comprising a pulse frequency F between 0.01 and 150 Hz.

[0036] According to one embodiment, the electrical stimulation signal comprises a pulse duration D of 0.01 to 100 ms.

[0037] According to one embodiment, the electrical stimulation signal comprises a pulse amplitude A of 1-15 mA.

[0038] According to one embodiment, the electrical stimulation signal comprises a pulse frequency of 0.15-0.25 Hz, a pulse duration of 20-30 ms, and a pulse amplitude of 3-10 mA.

[0039] The electrical stimulation signal may include a build-up period X1 of 0.01 to 2 seconds, during which the amplitude gradually increases, a stimulation period X2 of 1 to 60 seconds, and a rest period X4 of 0.01 to 60 seconds, and the electrical signal may include a pulse frequency of 1 to 50 Hz and a pulse duration of 0.1 to 10 ms.

[0040] The controller may include a wireless remote control device and may be configured to indicate a functional status of the implantable energy source. The functional status may indicate a charge level of the implantable energy source.

[0041] According to one embodiment, the functional status indicates the temperature of at least one of the implantable energy source, the muscle tissue, and the electrode placement.

[0042] According to one embodiment, the implantable energy source is configured to be charged by an external energy source located outside the patient's body.

[0043] According to one embodiment, the device further comprises an implantable charger electrically connected to the implantable energy source and configured to allow charging of the implantable energy source by an external energy source.

[0044] The charger may include an electromagnetic coil configured to wirelessly receive power from an external energy source, and the charger may be configured to control charging of the implantable energy source based on the functional status.

[0045] According to one embodiment, the charger is configured to control charging of the implantable energy source by controlling the receipt of power from an external energy source at the implantable charger.

[0046] According to one embodiment, the charger is configured to control charging of the implantable energy source by controlling the transmission of power from an external energy source to the implantable charger.

[0047] The device may further include an implantable sensor S1 configured to sense action potentials generated by pacemaker cells in the muscle tissue, and the controller configured to control the electrical simulation based at least in part on the sensed action potentials, and according to one embodiment, the controller configured to generate electrical pulses that amplify the sensed action potentials.

[0048] The volume of the movement restriction device may be non-adjustable after implantation; alternatively, the volume of the movement restriction device is adjustable after implantation.

[0049] The movement restriction device may further comprise an injection port to allow fluid to be injected or extracted from the interior of the movement restriction device to change the volume of the movement restriction device after implantation.

[0050] The movement restriction device may include a biocompatible outer surface configured to rest against the bottom wall portion.

[0051] The movement restriction device may be substantially spherical or ovoid.

[0052] The movement limiting device may be configured to at least partially engage the bottom wall.

[0053] The movement restriction device in any of the embodiments herein may be configured to be introduced into a patient's body by a gastroscope or an intraluminal instrument.

[0054] The movement restriction device can be configured to change shape during insertion into a patient's body to allow it to pass through a trocar.

[0055] According to one embodiment, the movement restriction device is formed from at least two separate separable parts that are configured to be assembled into a movement restriction device after insertion into a patient's body.

[0056] The minimum width of the movement restriction device in any of the embodiments herein may be 20mm or more, or 30mm or more, such as 40mm or more, measured from side to side.

[0057] The minimum circumference of the movement restriction device may be 150mm or less, such as 130mm or less, for example 110mm or less, such as 90mm or less, for example 70mm or less, such as 50mm or less, for example 30mm or less.

[0058] Also provided is an apparatus for treating reflux disease in a human patient. The apparatus includes an implantable movement restriction device configured to be secured between an upper portion of a patient's stomach and a thoracic diaphragm to restrict movement of the patient's cardia toward the thoracic diaphragm. The implantable movement restriction device has a first cross-sectional distance and a second cross-sectional distance, and the movement restriction device is configured to be implanted such that the first cross-sectional distance is more parallel to the patient's cranial-coccygeal axis than perpendicular, and the second cross-sectional distance is more perpendicular to the patient's cranial-coccygeal axis than parallel. The implantable movement restriction device is in situ adjustable such that the shape of the implantable movement restriction device can be adjusted by adjusting the length of the first cross-sectional distance such that the length of the first cross-sectional distance can be increased relative to the length of the second cross-sectional distance.

[0059] According to one embodiment, the shape of the implantable movement restriction device can be adjusted by increasing the length of a first cross-sectional distance relative to the length of a second cross-sectional distance while the length of the circumference of the cross-section of the implantable movement restriction device in a plane parallel to the patient's coronal plane remains constant.

[0060] According to one embodiment, the shape of the implantable movement restriction device can be adjusted to an elongated shape by increasing the length of the first cross-sectional distance relative to the length of the second cross-sectional distance.

[0061] According to one embodiment, the shape of the implantable movement restriction device can be adjusted by increasing the length of the first cross-sectional distance relative to the length of the second cross-sectional distance such that the circumferential length of the cross section of the implantable movement restriction device in a plane parallel to the patient's coronal plane increases relative to the circumferential length of the cross section of the implantable movement restriction device in a plane parallel to the patient's transverse plane.

[0062] According to one embodiment, the implantable movement restriction device comprises a lower portion configured to directly or indirectly engage the patient's stomach in the region of the angle of His such that the function of the implantable movement restriction device is supported by stomach tissue in the region of the angle.

[0063] According to one embodiment, an implantable movement restriction device comprises an upper portion configured to directly or indirectly engage a patient's thoracic diaphragm, the upper portion comprising at least one curved portion.

[0064] According to one embodiment, the implantable movement restriction device is configured to be at least partially invaginated by the stomach wall.

[0065] The implantable migration restriction device can be configured to be at least partially invaginated by the stomach wall of the fundus.

[0066] According to one embodiment, the movement restriction device includes a curved cross-section in a plane parallel to the patient's cross-section. The curve may be configured to partially encircle the patient's esophagus. According to one embodiment, the movement restriction device is configured to encircle at least one-third of the esophagus in a plane parallel to the patient's cross-section, while in another embodiment, the movement restriction device is configured to encircle at least one-half of the esophagus in a plane parallel to the patient's cross-section, and in another embodiment, the movement restriction device is configured to encircle at least two-thirds of the esophagus in a plane parallel to the patient's cross-section.

[0067] According to one embodiment, a cross-section of the movement restriction device in a plane parallel to the patient's transverse plane comprises a closed curve configured to encircle the patient's esophagus.

[0068] According to one embodiment, the movement restriction device is hydraulically adjustable. The movement restriction device may include a conduit configured to connect the hydraulically adjustable movement restriction device to the implantable injection port.

[0069] The hydraulically adjustable travel limiter may include an injection port so that the travel limiter may be adjusted by injecting or withdrawing hydraulic fluid into the hydraulically adjustable travel limiter. The travel limiter may comprise, in part, a bellows, and injecting or withdrawing hydraulic fluid into the hydraulically adjustable travel limit adjusts the length of the bellows.

[0070] According to one embodiment, the travel limiting device comprises a wall surrounding a hydraulic regulating chamber, and the thickness of the wall is varied to change the shape of the travel limiting device as fluid is injected into or withdrawn from the travel limiting device.

[0071] According to one embodiment, the shape of the travel limiting device changes by causing thinner portions of the wall surrounding the hydraulic regulation chamber to deform more than thicker portions of the wall surrounding the hydraulic regulation chamber.

[0072] According to one embodiment, the travel limiting device is mechanically adjustable and may consist of a mechanical operating device.

[0073] According to one embodiment, the movement limiter comprises a transmission element configured to transmit at least one of electrical energy and mechanical force to the mechanically adjustable movement limiter.

[0074] According to one embodiment, the transfer element includes at least one of the following: Electrical leads, shafts for transmitting rotational force, shafts for transmitting linear force.

[0075] According to one embodiment, the mechanical operating device includes an electric motor.

[0076] The mechanical manipulation device may include a transmission configured to convert a rotational force generated by the electric motor into a linear force for adjusting the length of the first cross-sectional distance.

[0077] According to one embodiment, part of the travel limiting device is a bellows, and the length of the bellows is adjusted by operating a mechanical operating device.

[0078] In other embodiments, the movement limiter is electrically adjustable.

[0079] According to one embodiment, the movement restriction device includes at least one material configured to change shape when exposed to an electric current or voltage. Such material may include at least one electroactive polymer, which may be an electroactive polymer selected from the list consisting of ferroelectric polymers, electrostrictive graft polymers, electrostrictive paper, piezoelectric polymers, and liquid crystal elastomers.

[0080] According to one embodiment, the movement restriction device further comprises a transmission element configured to transmit electrical energy to the movement restriction device.

[0081] According to one embodiment, the length of the first cross-sectional distance is adjustable in situ to be 1.2 times the length of the second cross-sectional distance, or 1.3 times the length of the second cross-sectional distance, or 1.5 times the length of the second cross-sectional distance.

[0082] According to one embodiment, the length of the first cross-sectional distance is adjustable in situ to be 1.2 times the circumference of the cross section of the implantable movement restriction device in a plane parallel to the patient's coronal plane, 1.2 times the circumference of the cross section of the implantable movement restriction device in a plane parallel to the patient's transverse plane, or 1.3 times the circumference of the cross section of the implantable movement restriction device in a plane parallel to the patient's transverse plane, or 1.5 times the circumference of the cross section of the implantable movement restriction device in a plane parallel to the patient's transverse plane.

[0083] According to one embodiment, the length of the first cross-sectional distance is adjustable in situ such that the center of gravity of the movement restriction device in a plane parallel to the patient's transverse plane is located at a distance greater than 20 mm or greater than 30 mm from the His angle.

[0084] According to one embodiment, the length of the first cross-sectional distance is adjustable in situ such that the center of gravity of the movement restriction device in a plane parallel to the patient's transverse plane is located at a distance greater than 5 mm or greater than 10 mm from the uppermost point of the cardia.

[0085] In any of the embodiments herein, the movement restriction device may include at least two parts.

[0086] In any of the embodiments herein, the device may further comprise an implantable energy source configured to power the adjustable implantable movement restriction device, which may be located internal to the movement restriction device or may be located subcutaneously.

[0087] In any of the embodiments herein, the device may further include at least one electrode for electrically stimulating at least one tissue portion of the patient.

[0088] According to one embodiment, the movement restriction device has a contracted state for preventing the passage of fluid from the stomach to the esophagus and an expanded state for allowing the passage of food into the stomach in response to the patient swallowing. The movement restriction device may include at least one attractor for elastically attracting adjacent portions of the movement restriction device to generate an enveloping pressure in the esophagus, and the attractor may include an elastic element.

[0089] According to one embodiment, the attractor comprises at least two magnets that attract each other.

[0090] An apparatus for treating reflux disease in a human patient is also provided. The apparatus includes an implantable movement restriction device configured to be secured between the patient's upper stomach and the thoracic diaphragm and to restrict movement of the patient's cardia toward the thoracic diaphragm. The implantable movement restriction device includes a first portion having a first volume surrounded by implantable movement restriction device material, and a second portion different from the first portion having a second volume surrounded by implantable movement restriction device material. The first and second volumes are equally large, the first volume having a higher density than the second volume, and the second volume having a density of 1000 kg / m. 3 has a density of less than

[0091] According to one embodiment, the first volume comprises a first solid material, which may comprise a polymeric material.

[0092] According to one embodiment, the first solid material includes at least one of a silicone-based material and a polyurethane-based material.

[0093] According to one embodiment, the second volume includes a second solid material, which may include a polymeric material. The second solid material may include at least one of a polypropylene-based material and a polyethylene-based material.

[0094] The first volume is 1000 kg / m 3 the second volume containing a solid material having a density equal to or greater than 1000 kg / m 3 The solid material may include a solid material having a density less than 1000 .mu.m.

[0095] According to one embodiment, the second volume contains a fluid, the fluid having a viscosity of 1000 kg / m 3 The liquid may have a density less than 1000 kJ / g, for example a liquid selected from the list of oil-based liquids and alcohol-based liquids.

[0096] According to one embodiment, the second volume comprises a gas, and the second volume may comprise multiple volumes of gas surrounded by surrounding material.

[0097] According to one embodiment, the second volume comprises a solid polymer material surrounding an enveloping material, the enveloping material being harder than the solid polymer material.

[0098] According to one embodiment, the plurality of gas volumes surrounded by the surrounding material occupy at least 10% by volume of the second volume, more preferably at least 20% by volume of the second volume, and even more preferably at least 30% by volume of the second volume.

[0099] The surrounding material may be composed of glass.

[0100] According to one embodiment, the travel limiting device has a resistance of 1100 kg / m 3 or less, or 1050 kg / m 3 or less than 1000 kg / m 3 It has the following average density:

[0101] According to one embodiment, the movement restriction device comprises a first cross-sectional distance and a second cross-sectional distance. The movement restriction device may be configured to be implanted such that the first cross-sectional distance is more parallel to the patient's cranial-coccygeal axis than perpendicular and the second cross-sectional distance is more perpendicular to the patient's cranial-coccygeal axis than parallel. The implantable movement restriction device may be adjustable in situ such that the length of the first cross-sectional distance can be increased relative to the length of the second cross-sectional distance such that the shape of the implantable movement restriction device can be adjusted by adjusting the length of the first cross-sectional distance.

[0102] According to one embodiment, the shape of the implantable movement restriction device can be adjusted by increasing the length of a first cross-sectional distance relative to the length of a second cross-sectional distance while the length of the circumference of the cross-section of the implantable movement restriction device in a plane parallel to the patient's coronal plane remains constant.

[0103] According to one embodiment, the implantable movement restriction device comprises a lower portion configured to directly or indirectly engage the patient's stomach in the region of the angle of His such that function of the implantable movement restriction device is supported by stomach tissue in the region of the angle of His.

[0104] According to one embodiment, an implantable movement restriction device comprises an upper portion configured to directly or indirectly engage a patient's thoracic diaphragm, the upper portion comprising at least one curved portion.

[0105] The implantable movement restriction device, in any of the embodiments herein, may be at least partially invaginated by the stomach wall.

[0106] According to one embodiment, the implantable movement restriction device is configured to be at least partially invaginated by the stomach wall at the fundus.

[0107] According to one embodiment, the implantable movement restriction device includes at least one circular cross-section.

[0108] The implantable movement restriction device, in any of the embodiments herein, may include at least two components, and the at least two components may be configured to be assembled to form the implantable movement restriction device. The at least two components may be configured to be connected to each other to form the implantable movement restriction device.

[0109] According to one embodiment, the device further comprises an interconnecting component configured to couple to at least two components, wherein at least one of the two components and the interconnecting component comprises a coupling recess, and at least one of the two components and the interconnecting component comprises a coupling protrusion, and wherein the at least one coupling protrusion and the at least one coupling recess are configured to couple to each other to form the implantable movement restriction device.

[0110] According to one embodiment, the movement restriction device has a curved cross-section in a plane parallel to the patient's transverse plane, the curve being configured to partially surround the patient's esophagus.

[0111] According to one embodiment, the movement restriction device is configured to encircle at least 1 / 3 of the esophagus in a plane parallel to the patient's cross-section, or to encircle at least 1 / 2 of the esophagus in a plane parallel to the patient's cross-section, or to encircle at least 2 / 3 of the esophagus in a plane parallel to the patient's cross-section.

[0112] According to one embodiment, the movement restriction device has a C-shaped cross-section in a plane parallel to the patient's transverse plane, the C-shaped cross-section being configured to partially surround the patient's esophagus.

[0113] According to one embodiment, a cross-section of the movement restriction device in a plane parallel to the patient's transverse plane comprises a closed curve configured to encircle the patient's esophagus.

[0114] According to one embodiment, the movement restriction device has a contracted state for preventing the passage of fluid from the stomach to the esophagus and an expanded state for allowing the passage of food into the stomach in response to the patient's swallowing. The movement restriction device may include at least one attractor for elastically attracting adjacent portions of the movement restriction device to generate an enveloping pressure within the esophagus. The attractor may include an elastic element or at least two mutually attracting magnets.

[0115] An apparatus for treating reflux disease in a human patient is also provided. The apparatus includes an implantable movement restriction device configured to be at least partially invaginated by the patient's stomach wall to restrict movement of the patient's cardia toward the thoracic diaphragm. The implantable movement restriction device has a first cross-sectional distance and a second cross-sectional distance, the first cross-sectional distance having a first length and the second cross-sectional distance having a second length. The first length is 1.5 times or greater than the second length. The movement restriction device is configured to be implanted such that the first cross-sectional distance is more parallel, and the second cross-sectional distance is more perpendicular than parallel to the patient's cranio-coccygeal axis. The implantable movement restriction device includes at least a first portion and a second portion configured to be connected to form the implantable movement restriction device. The center of gravity of the first portion lies on a plane extending perpendicularly from a front half of the first cross-sectional distance, the center of gravity of the second portion lies on a plane extending perpendicularly from a rear half of the first cross-sectional distance, a lower portion of the first portion constitutes a first connecting portion, and an upper portion of the second portion constitutes a second connecting portion. The first connecting portion and the second connecting portion are configured to be connected to each other, and the first connecting portion and the second connecting portion are configured to maintain their connected state by support or compression of at least one of the first portion and the second portion due to invagination of the implantable movement restriction device in the patient's stomach wall, and the first portion and the second portion are separable from the stomach wall when support or compression from at least one of the first portion and the second portion is reduced.

[0116] The first connecting portion and the second connecting portion may be configured to be directly connected to each other, or may be configured to be indirectly connected to each other via an interconnecting portion.

[0117] According to one embodiment, at least one of the first portion, the second portion, and the interconnecting portion comprises a coupling recess, and at least one of the first portion, the second portion, and the interconnecting portion comprises a coupling protrusion, and the at least one coupling protrusion and one coupling recess are configured to be interconnected to form an implantable movement restriction device.

[0118] According to one embodiment, at least one of the first and second connecting portions includes a resilient connecting portion, the resilient connecting portion being supported or compressed by invagination of the implantable movement to connect, directly or indirectly, the first portion to the second portion.

[0119] According to one embodiment, the resilient coupling comprises a resilient protrusion configured to engage a recess for directly or indirectly coupling the first component to the second component, and the resilient protrusion may be configured to couple and uncouple with the recess in a direction substantially perpendicular to the direction of the first cross-sectional distance.

[0120] According to one embodiment, the first part includes a first sub-part and a second sub-part, and / or the second part includes a first sub-part and a second sub-part.

[0121] Each of the first sub-part and the second sub-part may include an interconnecting portion, and each of the first sub-part and the second sub-part may be configured to connect and disconnect from the interconnecting portion of the first part or the second part of the interconnecting portion in a direction substantially perpendicular to the direction of the first cross-sectional distance.

[0122] According to one embodiment, the first sub-component and the second sub-component are configured to remain connected to one another by at least one of the first and second components being supported or compressed by invagination of the implantable movement restriction device in the patient's stomach wall, and the first and second components can be decoupled and separated from one another when the support or compression from the stomach wall on at least one of the first and second components is reduced.

[0123] According to one embodiment, the first part includes first and second sub-parts, which are configured to remain connected by being supported or compressed by a connecting portion of the second part.

[0124] According to one embodiment, the second part is configured to exert a supportive or compressive force on the first part resulting from the supportive or compressive force exerted by the stomach wall on the second part.

[0125] According to one embodiment, the first part includes a first sub-part and a second sub-part, and the second part includes a first sub-part and a second sub-part, the first and second sub-parts of the first part being configured to remain coupled together by a support or compressive force exerted by at least one of the second part and the stomach wall, and the first and second sub-parts of the second part being configured to remain coupled together by a support or compressive force exerted by the stomach wall.

[0126] According to one embodiment, the implantable movement restriction device further comprises a third component, wherein a lower portion of the second component forms a third connecting portion and an upper portion of the third component forms a fourth connecting portion, such that the first, second and third components can be connected to form the implantable medical device.

[0127] According to one embodiment, the second part is configured to exert a supportive or compressive force on the first part resulting from a supportive or compressive force exerted on the second part by the third part. The third part may be configured to exert a supportive or compressive force on the second part resulting from a supportive or compressive force exerted on the third part by the stomach wall.

[0128] According to one embodiment, the device further comprises a second interconnecting portion, and the third and fourth interconnecting portions are configured to be connected to the second interconnecting portion, such that the first interconnecting portion connects the first portion to the second portion and the second interconnecting portion connects the third portion to the fourth portion.

[0129] According to one embodiment, the first and second resilient connecting portions are supported or compressed by a supporting or compressive force exerted on the second portion by the third portion.

[0130] According to one embodiment, the first part includes a first sub-part and a second sub-part, the second part includes a first sub-part and a second sub-part, and the third part includes a first sub-part and a second sub-part, wherein the first and second sub-parts of the first part are configured to remain coupled to each other by a support or compressive force exerted by at least one of the second part and the stomach wall, the first and second sub-parts of the second part are configured to remain coupled to each other by a support or compressive force exerted by at least one of the third part and the stomach wall, and the first and second sub-parts of the third part are configured to remain coupled to each other by a support or compressive force exerted by the stomach wall.

[0131] According to one embodiment, the first part comprises first, second and third sub-parts, and / or the second part comprises first, second and third sub-parts, and / or the third part comprises first, second and third sub-parts.

[0132] According to one embodiment, the first part comprises first, second, third and fourth sub-parts, and / or the second part comprises first, second, third and fourth sub-parts, and / or the third part comprises first, second, third and fourth sub-parts.

[0133] According to one embodiment, the movement restriction device is elongate, the first length being at least twice the second length, preferably at least 2.5 times the second length, more preferably at least 3 times the second length.

[0134] According to one embodiment, the implantable movement restriction device includes at least one circular cross-section.

[0135] The implantable movement restriction device can comprise first, second and third cross sections in spaced apart parallel planes, the first and third cross sections having the same area and the second cross section being located between the first and third cross sections and having a smaller area. According to one embodiment, the implantable movement restriction device further comprises fourth and fifth cross sections in spaced apart parallel planes relative to the planes of the first, second and third cross sections, the third and fifth cross sections having the same area and the fourth cross section being located between the third and fifth cross sections and having a smaller area.

[0136] According to one embodiment, the implantable movement restriction device may be configured to undergo complete invagination.

[0137] The first portion of the implantable movement restriction device may have a first volume surrounded by implantable movement restriction device material, and the second portion of the movement restriction device may have a second volume separate from the first portion surrounded by implantable movement restriction device material, the first volume and the second volume being equally large, the first volume having a higher density than the second volume, and the second volume having a density of 1000 kg / m 3 has a density of less than

[0138] According to one embodiment, the first volume comprises a first solid material, which may comprise a polymeric material such as a silicone-based material or a polyurethane-based material.

[0139] According to one embodiment, the second volume comprises a second solid material, which may comprise a polymeric material such as a polypropylene-based material or a polyethylene-based material.

[0140] In any of the embodiments described herein, the first volume is greater than or equal to 1000 kg / m 3 The second volume may include a solid material having a density greater than 1000 kg / m 3 The solid material may include a solid material having a density less than 1000 .mu.m.

[0141] In any of the embodiments herein, the second volume may contain a fluid, the fluid having a viscosity of 1000 kg / m, for example, an oil-based liquid or an alcohol-based liquid. 3 The liquid may have a density less than 1000 .mu.m.

[0142] In any of the embodiments herein, the second volume may include a gas, and the second volume may include multiple volumes of gas surrounded by a surrounding material.

[0143] According to one embodiment, the second volume may include a solid polymer material surrounding an enveloping material, which may be harder than the solid polymer material.

[0144] According to one embodiment, the plurality of gas volumes surrounded by the surrounding material occupy at least 10% by volume of the second volume, more preferably at least 20% by volume of the second volume, and even more preferably at least 30% by volume of the second volume.

[0145] The surrounding material may include glass.

[0146] According to one embodiment, the travel limiting device has a resistance of 1100 kg / m 3 Average density of less than or equal to 1050 kg / m3 Average density below or equal to 1000 kg / m 3 It has the following average density:

[0147] According to one embodiment, the movement restriction device comprises a first cross-sectional distance and a second cross-sectional distance. The implantable movement restriction device may be adjustable in situ such that the shape of the implantable movement restriction device may be adjusted by adjusting the length of the first cross-sectional distance such that the length of the first cross-sectional distance may be increased relative to the length of the second cross-sectional distance.

[0148] According to one embodiment, the shape of the implantable movement restriction device can be adjusted by increasing the length of a first cross-sectional distance relative to the length of a second cross-sectional distance while the length of the circumference of the cross-section of the implantable movement restriction device in a plane parallel to the patient's coronal plane remains constant.

[0149] The first portion, in any of the embodiments herein, may include an upper portion configured to directly or indirectly engage the patient's thoracic diaphragm, and the upper portion may include at least one curved portion.

[0150] There is also provided an apparatus for treating reflux disease in a human patient, the apparatus comprising an implantable movement restriction device configured to be at least partially invaginated by the patient's stomach wall to restrict movement of the patient's cardia toward the thoracic diaphragm, the implantable movement restriction device comprising a sensor configured to sense at least one of force and pressure to monitor pressure or force exerted by the implantable movement restriction device on the patient's stomach wall.

[0151] According to one embodiment, the sensor is fixed to the surface of the implantable movement restriction device and / or incorporated into the implantable movement restriction device. The sensor may include a strain gauge-based sensor, such as a piezoresistive or piezoelectric strain gauge-based sensor or an optical strain gauge-based sensor. Alternatively, the sensor may include a capacitive sensor or an electromagnetic sensor.

[0152] According to one embodiment, the implantable movement restriction device comprises at least one sealed chamber containing a fluid, and a sensor configured to sense pressure within the fluid. The device may further comprise at least one conduit configured to house the sensor and a sensor unit, the conduit being in fluid communication with the sealed chamber of the implantable movement restriction device and the sensor unit such that the sensor can sense pressure within the fluid within the sealed chamber of the implantable movement restriction device via fluid communication provided by the conduit.

[0153] According to one embodiment, the device further comprises an implantable energy source for powering the sensor, and an implantable controller connected to the sensor, which may comprise a wireless transceiver configured to receive a sensor signal from the sensor and transmit a wireless signal derived from the sensor signal to a unit external to the patient's body.

[0154] According to one embodiment, the implantable movement restriction device is sized such that the implantable movement restriction device can be completely invaginated by the patient's bottom wall.

[0155] The device may further include at least one lead connected to the sensor, the lead configured to connect the sensor to an external device configured to remain outside the patient's body. The device may further include a connector for removably connecting the sensor to the lead, thereby allowing the lead to be disconnected from the sensor.

[0156] In alternative embodiments, the sensor may be removably attached to the implantable movement restriction device, the sensor may be removed from the implantable movement restriction device by pulling on the lead, or the sensor may be removably attached to the implantable movement restriction device using an adhesive.

[0157] The implantable movement restriction device may be any of the embodiments herein, including a 200 cm 2 less than 100cm², preferably less than 50cm² 2 It may have a size less than

[0158] According to one embodiment, the movement restriction device is elongate, the first cross-sectional distance having a first length and the second cross-sectional distance having a second length, the first length being at least 1.2 times the second length, preferably at least 1.5 times the second length, and more preferably at least 2 times the second length.

[0159] According to one embodiment, the implantable movement restriction device includes at least one circular cross-section.

[0160] According to one embodiment, an implantable movement restriction device includes first, second, and third cross sections in spaced-apart, parallel planes, the first and third cross sections having the same area, and the second cross section located between the first and third cross sections and having a smaller area.

[0161] According to one embodiment, the implantable movement restriction device comprises at least two sections, or at least three sections, or at least four sections.

[0162] According to one embodiment, at least two components are configured to be assembled to form an implantable movement restriction device, and at least two components may be configured to be connected to each other to form the implantable movement restriction device.

[0163] According to one embodiment, the movement restriction device has a curved cross-section in a plane parallel to the patient's transverse plane, the curve being configured to partially surround the patient's esophagus.

[0164] According to one embodiment, the movement restriction device includes a curved cross-section in a plane parallel to the patient's cross-section. The curve may be configured to partially encircle the patient's esophagus. According to one embodiment, the movement restriction device is configured to encircle at least one-third of the esophagus in a plane parallel to the patient's cross-section, while in another embodiment, the movement restriction device is configured to encircle at least one-half of the esophagus in a plane parallel to the patient's cross-section, while in another embodiment, the movement restriction device has a C-shaped cross-section in a plane parallel to the patient's cross-section, the C-shaped cross-section being configured to partially encircle the patient's esophagus, while in another embodiment, the movement restriction device is configured to encircle at least two-thirds of the esophagus in a plane parallel to the patient's cross-section.

[0165] According to one embodiment, a cross-section of the movement restriction device in a plane parallel to the patient's transverse plane comprises a closed curve configured to encircle the patient's esophagus.

[0166] The implantable movement restriction device, in any embodiment, can include at least one circular cross-section.

[0167] There is also provided a surgical instrument for assisting in a surgical procedure for implanting an implantable movement restriction device, the movement restriction device being configured to be at least partially invaginated by a patient's stomach wall to restrict movement of the patient's cardia toward the thoracic diaphragm, the surgical instrument including a manipulation portion configured to remain outside the patient's body during use, a distal portion configured to be inserted into the patient's body, and a lead at least partially attached to the distal portion and configured to be connected to a sensor for sensing at least one of force and pressure to monitor the pressure or force exerted by the implantable movement restriction device on the patient's stomach wall during implantation.

[0168] According to one embodiment, the distal portion comprises a retaining device connected to the operating portion and configured to be inserted into the patient's body and to engage the movement restriction device.

[0169] According to one embodiment, the retention device includes an elongated portion configured to be inserted into the implantable movement restriction device.

[0170] According to one embodiment, the retention device comprises a gripping portion configured to grip the implantable movement restriction device.

[0171] The surgical instrument may be configured for deployment of an implantable movement restriction device, the surgical instrument further comprising a sleeve connected to the manipulation portion, the retaining device configured to be partially disposed within the sleeve and displaceable relative to the sleeve, wherein handling of the manipulation portion displaces the retaining device relative to the sleeve, thereby disengaging the retaining device from the movement restriction device to perform deployment of the movement restriction device.

[0172] According to one embodiment, the distal portion is angled relative to the major length axis of the surgical instrument, and the distal portion may be angled by more than 20 degrees relative to the major length axis of the instrument.

[0173] According to one embodiment, the distal portion is flexible or bendable.

[0174] According to one embodiment, the bending of the distal portion is controllable from the control portion.

[0175] According to one embodiment, the surgical instrument is an intraperitoneal surgical instrument configured to be inserted into a patient's abdominal cavity during an open surgery, in another embodiment the surgical instrument is a laparoscopic instrument configured to be inserted into a patient's abdomen through a trocar, and in yet another embodiment the surgical instrument is a gastroscopic surgical instrument configured to be inserted into the patient's body through the patient's esophagus.

[0176] According to one embodiment, the surgical instrument further comprises a sensor, which may be configured to be removably attached to the implantable movement restriction device, such that the sensor can be detached from the implantable movement restriction device and removed from the patient's body during the surgical procedure.

[0177] According to one embodiment, the sensor is configured to be attached to or within the implantable movement restriction device. The sensor may be configured to be removably attached to the implantable movement restriction device using an adhesive. The surgical instrument may further include a connector for removably connecting the sensor to a lead, allowing the lead to be disconnected from the sensor. The sensor may include a strain gauge-based sensor, such as a piezoresistive or piezoelectric strain gauge-based sensor, an optical strain gauge-based sensor, a capacitive sensor, or an electromagnetic sensor.

[0178] According to one embodiment, the implantable movement restriction device comprises at least one sealed chamber containing a fluid, and the sensor is a sensor configured to sense pressure within the fluid.

[0179] According to one embodiment, the surgical instrument further comprises an energy source for powering the sensor and a controller connected to the sensor, the controller may be an external device configured to remain outside the patient when the surgical instrument is being used, the controller configured to receive the sensor signal from the sensor via the lead and to provide an output based on the sensor signal.

[0180] According to one embodiment, the controller comprises an output device configured to provide an output to the person, the output device comprising at least one unit selected from the list consisting of a unit providing an audio output, a unit providing a visual output such as a lighting unit or a display unit, and a unit providing a tactile output.

[0181] There is also provided a device for treating reflux disease in a human patient, the device comprising an elongated core having a length that enables the core to at least partially encircle the patient's esophagus, the core comprising a first length-adjusting feature that enables the core to be positioned in a contracted state for preventing the passage of fluid from the stomach 10 into the esophagus and an expanded state for allowing the passage of food into the stomach in response to the patient's swallowing, and a second length-adjusting feature for post-operatively adjusting the length of the core in the contracted state.

[0182] According to one embodiment, the second length-adjusting feature comprises a hydraulic length-adjusting feature and may include at least one hydraulic chamber, wherein the length of the core may be adjusted post-operatively by injecting or withdrawing fluid into or from the at least one hydraulic chamber. The hydraulic chamber may include at least one pleated portion, such as at least one bellows.

[0183] According to one embodiment, the elongated core includes a wall surrounding the hydraulic chamber, the wall thickness varying to affect a change in the shape of the hydraulic chamber as fluid is injected into or withdrawn from the hydraulic chamber.

[0184] According to one embodiment, the shape of the movement limiting device may be changed by thinner portions of the wall surrounding the hydraulic pressure regulation chamber deforming more than thicker portions of the wall surrounding the hydraulic pressure regulation chamber.

[0185] According to one embodiment, the hydraulic chamber includes or is connected to at least one implantable injection port.

[0186] According to one embodiment, the second length variability function comprises a mechanical length variability function, which may comprise a powered mechanical length variability function.

[0187] According to one embodiment, the powered mechanical length varying feature may include at least one of an electric motor, an electromagnet, and an electroactive material.

[0188] According to one embodiment, the movement limiting device comprises a transmission element configured to transmit at least one of electrical energy and mechanical force to the mechanical length varying feature.

[0189] According to one embodiment, the transmission element comprises at least one of an electrical lead, a shaft for transmitting rotational force, and a shaft for transmitting linear force.

[0190] The mechanical manipulation device may include a transmission configured to convert a rotational force generated by the electric motor into a linear force for adjusting the length of the first cross-sectional distance.

[0191] According to one embodiment, the first length-variable feature includes multiple sections that are movable relative to one another.

[0192] According to one embodiment, the first length-variable feature comprises an attractor for resiliently attracting adjacent portions of the elongate core to one another. The attractor may comprise an elastic element or may comprise at least two mutually attracting magnets.

[0193] According to one embodiment, the device further comprises a link connecting a first magnet and a second magnet of the at least two magnets to each other.

[0194] According to one embodiment, the elongate core is configured to exert a surrounding pressure on the esophagus in a contracted state.

[0195] According to one embodiment, the device comprises two ends configured to be joined together to form a closed ring around the esophagus, and the ends may be configured to be releasably attached to one another and may comprise respective interlocking attachments.

[0196] According to one embodiment, the elongate core includes a plurality of bodies configured to be arranged in an annular fashion around the esophagus.

[0197] According to one embodiment, the elongate core further comprises a plurality of links, each link extending between a respective pair of bodies disposed adjacent to one another.

[0198] According to one embodiment, at least one of the plurality of bodies includes a second length-adjusting feature for post-operatively adjusting the length of the core in a contracted state.

[0199] According to one embodiment, at least one of the bodies comprises a hydraulic chamber for post-operative adjustment of the length of the core in a contracted state.

[0200] The elongated core may be sized to allow at least a portion of the elongated core to protrude above the patient's cardiac sphincter when implanted, restricting movement of the cardia toward the diaphragm and preventing the cardia from sliding through the diaphragmatic opening 32 into the patient's thoracic cavity.

[0201] According to one embodiment, the elongate core has a maximum height, measured normal to the plane in which the elongate core extends as it encircles the esophagus, of greater than 2 cm, hi alternative embodiments, the maximum height may be 3 cm or greater, such as 4 cm or greater, for example 5 cm or greater.

[0202] According to one embodiment, the elongate core is configured to be implanted such that a portion of the elongate core having a maximum height is positioned fundally in the esophagus.

[0203] According to one embodiment, the elongated core has a first cross-sectional distance and a second cross-sectional distance, the elongated core is configured to be implanted such that the first cross-sectional distance is more parallel than perpendicular to the patient's cranial-coccygeal axis, and the second cross-sectional distance is more perpendicular than parallel to the patient's cranial-coccygeal axis, and the elongated core is adjustable in situ such that the length of the first cross-sectional distance can be increased relative to the length of the second cross-sectional distance such that the shape of the elongated core can be adjusted by adjusting the length of the first cross-sectional distance.

[0204] According to one embodiment, the shape of the elongate core can be adjusted by increasing the length of the first cross-sectional distance relative to the length of the second cross-sectional distance while the length of the circumference of the cross-section of the elongate core in a plane parallel to the patient's coronal plane remains constant.

[0205] According to one embodiment, the cross-sectional shape of the elongated core can be adjusted to be elongated by increasing the length of the first cross-sectional distance relative to the length of the second cross-sectional distance.

[0206] According to one embodiment, the elongate core comprises a lower portion configured to directly or indirectly engage the patient's stomach in the region of the angle of His such that function of the elongate core is supported by stomach tissue in the region of the angle of His.

[0207] According to one embodiment, the elongate core comprises an upper portion configured to directly or indirectly engage the patient's thoracic diaphragm, the upper portion including at least one curve.

[0208] The elongate core in any of the embodiments herein may be configured to be at least partially invaginated by the stomach wall.

[0209] According to one embodiment, the elongate core is configured to at least partially invaginate the fundus stomach wall.

[0210] According to one embodiment, the movement restriction device includes a curved cross-section in a plane parallel to the patient's cross-section. The curve may be configured to partially encircle the patient's esophagus. According to one embodiment, the movement restriction device is configured to encircle at least one-third of the esophagus in a plane parallel to the patient's cross-section, while in another embodiment, the movement restriction device is configured to encircle at least one-half of the esophagus in a plane parallel to the patient's cross-section, while in another embodiment, the movement restriction device has a C-shaped cross-section in a plane parallel to the patient's cross-section, the C-shaped cross-section being configured to partially encircle the patient's esophagus, while in another embodiment, the movement restriction device is configured to encircle at least two-thirds of the esophagus in a plane parallel to the patient's cross-section.

[0211] The second length-variable feature may be configured in any of the embodiments herein to post-operatively adjust the length that the core has in its contracted state by 5% or more, or 10% or more, or 15% or more, or 20% or more.

[0212] The device, in any of the embodiments herein, may include at least one electrode for electrically stimulating at least one tissue portion of the patient.

[0213] Further provided is a device for treating reflux disease in a human patient, comprising an elongated core having a length that enables the elongated core to at least partially encircle the patient's esophagus, a first length-variable feature that enables the core to be positioned in a contracted state to prevent the passage of fluid from the stomach to the esophagus and an expanded state to allow the passage of food to the stomach in response to the patient's swallowing, and a protruding portion configured to protrude from the first length-variable feature in a direction more parallel than perpendicular to the patient's cranial-coccygeal axis, substantially cranially, when the elongated core is implanted. The protruding portion is configured to protrude a distance of at least 10 mm in a substantially cranial direction from a plane extending perpendicularly from the patient's cranial-coccygeal axis and containing the center of gravity of the elongated core, and the protruding portion is configured to directly or indirectly engage the patient's thoracic diaphragm to restrict movement of the patient's cardia.

[0214] The protrusion may protrude substantially cranially from a plane extending perpendicularly from the patient's cranio-coccygeal axis and containing the centre of gravity of the elongated core a distance of at least 20 mm.

[0215] The protrusion may be configured to extend perpendicularly from the patient's cranio-coccygeal axis and protrude substantially cranially from a plane containing the center of gravity of the elongated core, a distance such that an upper portion of the protrusion is positioned at least 5 mm above the cardiac sphincter.

[0216] The protrusion may be configured to extend perpendicularly from the patient's cranial-caudal axis and protrude substantially cranially from a plane containing the center of gravity of the elongated core, a distance such that an upper portion of the protrusion is positioned at least 10 mm above the cardiac sphincter.

[0217] The protrusion may be configured to extend perpendicularly from the patient's cranio-coccygeal axis and protrude substantially cranially from a plane containing the center of gravity of the elongated core, a distance such that an upper portion of the protrusion is positioned at least 15 mm above the cardiac sphincter.

[0218] The elongate core may have a first cross-sectional area in a first plane extending perpendicularly from the patient's cranio-coccygeal axis, and the protrusion may have a second cross-sectional area in a second plane parallel to the first plane, and the first cross-sectional area may be 1.5 times or greater than the second cross-sectional area.

[0219] According to one embodiment, the second cross-sectional area is the average cross-sectional area of ​​the protrusions.

[0220] According to one embodiment, the protrusion has a third cross-sectional area in a third plane parallel to the first plane, the second plane being located between the first plane and the third plane, and the third cross-sectional area being at least 1.5 times larger than the second cross-sectional area.

[0221] According to one embodiment, the device further comprises a second elongate core having a length such that the second elongate core at least partially surrounds the patient's esophagus. The protrusion may connect the first elongate core and the second elongate core.

[0222] According to one embodiment, the elongate core includes a lower portion configured to directly or indirectly engage the patient's stomach in the region of the angle of His, such that the function of the elongate core is supported by the patient's stomach tissue in the region of the angle of His.

[0223] According to one embodiment, the protrusion includes an upper portion configured to directly or indirectly engage the patient's thoracic diaphragm, the upper portion including at least one curved portion.

[0224] According to one embodiment, at least one of the first elongate core, the second elongate core and the protrusion may be configured to be at least partially invaginated by the stomach wall.

[0225] According to one embodiment, the protrusion is adjustable in situ such that the length the protrusion protrudes from a plane extending perpendicular to the patient's cranio-coccygeal axis and containing the center of gravity of the elongate core can be adjusted. The protrusion may be hydraulically adjustable and may further comprise a conduit configured to connect the hydraulically adjustable protrusion to an implantable injection port.

[0226] According to one embodiment, at least one of the protrusion and the elongate core includes an injection port such that hydraulic fluid can be injected or withdrawn from the injection port to adjust the hydraulically adjustable protrusion.

[0227] According to one embodiment, the protrusion comprises a bellows, the length of which is adjusted by injecting or withdrawing hydraulic fluid into the injection port.

[0228] According to one embodiment, the protrusion comprises a wall surrounding the hydraulic pressure regulation chamber, the thickness of the wall varying as fluid is injected into or withdrawn from the protrusion to change the shape of the protrusion, the shape of the protrusion may be changed by thinner portions of the wall surrounding the hydraulic pressure regulation chamber deforming more than thicker portions of the wall surrounding the hydraulic pressure regulation chamber.

[0229] According to one embodiment, the protrusion is mechanically adjustable and the device may include a mechanical operating device for mechanically adjusting the protrusion.

[0230] According to one embodiment, the movement restriction device comprises a transmission element configured to transmit at least one of electrical energy and mechanical force to the mechanically adjustable protrusion.

[0231] According to one embodiment, the transmission element includes at least one of an electrical lead, a shaft for transmitting rotational force, and a shaft for transmitting linear force.

[0232] The mechanical operating device may include an electric motor and a transmission configured to convert a rotational force generated by the electric motor into a linear force for adjusting the length of the protrusion.

[0233] A portion of the protrusion includes a bellows, and the length of the bellows is adjusted by operating the mechanical operating device.

[0234] According to one embodiment, the protrusions are electrically adjustable, and the device may comprise at least one material configured to change shape when exposed to an electric current or voltage, which may be at least one electroactive polymer selected from the list consisting of ferroelectric polymers, electrostrictive graft polymers, electrostrictive paper, piezoelectric polymers, and liquid crystal elastomers.

[0235] In any embodiment herein, the length of the protrusion may be adjustable in situ by 1.2 times or more, or 1.3 times or more, or 1.5 times or more.

[0236] According to one embodiment, the elongate core includes a curved cross-section in a plane parallel to the patient's transverse plane, the curved portion being configured to partially surround the patient's esophagus.

[0237] According to one embodiment, the movement restriction device includes a curved cross-section in a plane parallel to the patient's cross-section. The curve may be configured to partially encircle the patient's esophagus. According to one embodiment, the movement restriction device is configured to encircle at least one-third of the esophagus in a plane parallel to the patient's cross-section, while in another embodiment, the movement restriction device is configured to encircle at least one-half of the esophagus in a plane parallel to the patient's cross-section, while in another embodiment, the movement restriction device has a C-shaped cross-section in a plane parallel to the patient's cross-section, the C-shaped cross-section being configured to partially encircle the patient's esophagus, while in another embodiment, the movement restriction device is configured to encircle at least two-thirds of the esophagus in a plane parallel to the patient's cross-section.

[0238] According to one embodiment, a cross-section of the elongate core in a plane parallel to the transverse plane of the patient may comprise a closed curve configured to encircle the patient's esophagus.

[0239] According to one embodiment, the first length-variable feature includes an attractor for resiliently attracting adjacent portions of the elongate core toward one another. The attractor may include an elastic element or at least two mutually attracting magnets. The device may further include a link connecting a first magnet and a second magnet of the at least two magnets to one another.

[0240] According to one embodiment, the elongate core is configured to exert a surrounding pressure on the esophagus in a contracted state.

[0241] According to one embodiment, the device includes two ends configured to be joined together to form a closed ring around the esophagus. The ends may be configured to be releasably attached to one another and may include respective interlocking attachments.

[0242] The elongate core may include a plurality of bodies configured to be arranged in an annular fashion around the esophagus.

[0243] According to one embodiment, the elongate core further comprises a plurality of links, each link extending between a respective pair of bodies disposed adjacent to one another.

[0244] According to one embodiment, the elongate core is configured to be implanted such that the protrusion is positioned at the fundus of the esophagus.

[0245] The device may further include a second length-variable feature configured to post-activate adjust the length of the elongate core in its contracted state by 5% or more, or 10% or more, or 15% or more, or 20% or more.

[0246] The device, in any of the embodiments herein, may include at least one electrode for electrically stimulating at least one tissue portion of the patient.

[0247] Also provided is a method for treating reflux disease in a human patient by implanting a movement restriction device. The movement restriction device is positioned to restrict movement of the cardia of the patient's stomach toward the diaphragm, preventing the cardia from sliding through an opening in the diaphragm and into the patient's thoracic cavity. The movement restriction device has a curved inner surface configured to face the curved outer surface of the esophagus. The method includes positioning and securing the movement restriction device so that the curved inner surface surrounds at least one-third of the esophagus in a plane extending perpendicular to the cranial-coccygeal axis, the center of gravity of the movement restriction device is located in the plane extending perpendicular to the cranial-coccygeal axis, and the shortest distance from any point on the plane to the Angle of His is greater than 20 mm.

[0248] According to one embodiment, the method includes attaching a gastric fundus of the patient to the patient's esophagus at a first position below a center of mass of a movement restriction device, such that the movement restriction device is supported by attachment of the gastric fundus to the esophagus.

[0249] The step of attaching the fundus of the patient's stomach to the patient's esophagus at a first position may include attaching the fundus of the patient's stomach to the patient's esophagus at a position greater than 5 mm from the angle of His.

[0250] According to one embodiment, the step of positioning and fixing the movement restriction device includes positioning and fixing the movement restriction device such that a superior point of the movement restriction device is positioned in a second plane extending perpendicular to the cranio-coccygeal axis, and a shortest distance from a point on the second plane to the His angle is greater than 40 mm.

[0251] According to one embodiment, the step of positioning and fixing the movement restriction device includes positioning and fixing the movement restriction device such that the uppermost point of the movement restriction device is located in a second plane extending perpendicular to the cranio-coccygeal axis, and the shortest distance from a point on the second plane to the His angle is greater than 50 mm.

[0252] According to one embodiment, the step of positioning and fixing the movement restriction device includes positioning and fixing the movement restriction device such that the lowest point of the movement restriction device is located in a third plane that extends perpendicular to the cranio-coccygeal axis, and the shortest distance from a point on the third plane to the His angle is greater than 10 mm.

[0253] According to one embodiment, the step of positioning and fixing the movement restriction device includes positioning and fixing the movement restriction device such that the lowest point of the movement restriction device is located in a third plane extending perpendicular to the cranio-coccygeal axis, and the shortest distance from a point on the third plane to the His angle is greater than 20 mm.

[0254] According to one embodiment, the step of positioning and fixing the movement restriction device includes positioning and fixing the movement restriction device such that the uppermost point of the movement restriction device is positioned in a second plane extending perpendicular to the cranio-coccygeal axis, and the shortest distance from a point on the second plane to the uppermost point of the cardia is greater than 5 mm.

[0255] According to one embodiment, the step of positioning and fixing the movement restriction device includes positioning and fixing the movement restriction device such that the uppermost point of the movement restriction device is positioned in a second plane extending perpendicular to the cranio-coccygeal axis, and the shortest distance from a point on the second plane to the uppermost point of the cardia is greater than 10 mm.

[0256] According to one embodiment, the step of positioning and fixing the movement restriction device includes positioning the center of gravity of the movement restriction device on a second plane extending perpendicular to the cranio-coccygeal direction, wherein the shortest distance from a point on the second plane to the upper end point of the cardia is greater than 5 mm.

[0257] According to one embodiment, the step of positioning and fixing the movement restriction device includes positioning the center of gravity of the movement restriction device on a second plane extending perpendicular to the cranio-coccygeal direction, wherein the shortest distance from a point on the second plane to the upper end point of the cardia is greater than 10 mm.

[0258] According to one embodiment, the step of positioning and securing the movement restriction device includes positioning the movement restriction device to surround at least one-half of the esophagus in a plane extending perpendicular to the cranio-coccygeal direction.

[0259] According to one embodiment, the step of positioning and securing the movement restriction device includes positioning the movement restriction device to surround at least two-thirds of the esophagus in a plane extending perpendicular to the cranio-coccygeal direction.

[0260] According to one embodiment, the step of positioning and securing the movement restriction device includes positioning the movement restriction device surrounding the esophagus in a plane extending perpendicular to the cranio-coccygeal direction.

[0261] According to one embodiment, the curved inner surface configured to oppose the curved outer surface of the esophagus includes a radius of curvature that corresponds to or exceeds the radius of curvature of the esophagus, such that the curved inner surface has a radius of curvature that corresponds to or exceeds the radius of curvature of the esophagus.

[0262] According to one embodiment, the step of positioning and fixing the movement restriction device comprises positioning the movement restriction device including an electrode arrangement configured to electrically stimulate muscle tissue in the fundus portion and / or serosal portion to improve the conditions for long-term implantation of the movement restriction device.

[0263] According to one embodiment, the method further comprises implanting an implantable energy source configured to power the electrode.

[0264] According to one embodiment, the step of positioning and securing the movement restriction device includes positioning the movement restriction device having a contracted state to prevent the passage of fluid from the stomach to the esophagus and an expanded state to allow the passage of food to the stomach in response to the patient swallowing.

[0265] According to one embodiment, the step of positioning the movement restriction device includes positioning the movement restriction device configured to exert an enveloping pressure on the esophagus in a contracted state.

[0266] According to one embodiment, the step of positioning and fixing the movement restriction device includes positioning the movement restriction device to include at least one attractor for resiliently attracting adjacent portions of the movement restriction device to generate an enveloping pressure.

[0267] The attractor may include an elastic element or at least two magnets that attract each other. The apparatus may further include a link connecting a first magnet and a second magnet of the at least two magnets to each other.

[0268] According to one embodiment, the step of positioning and fixing the movement restriction device comprises positioning and fixing a movement restriction device having an adjustable volume.

[0269] According to a further aspect, it is an object to reduce the risk of migration of the implantable movement restriction devices disclosed herein. Migration of a movement restriction device is generally undesirable because it can reduce the effectiveness of treatment of reflux disease in human patients receiving the movement restriction device.

[0270] According to one aspect, a device for treating reflux disease in a human patient is provided. The device includes an implantable movement restriction device configured to be at least partially invaginated by the patient's stomach wall to restrict movement of the patient's cardia toward the thoracic diaphragm. The implantable movement restriction device includes a surface friction-reducing coating covering at least a portion of a surface of the implantable movement restriction device. The surface friction-reducing coating is configured to reduce friction between the implantable movement restriction device and tissue of the stomach wall into which the implantable movement restriction device is at least partially invaginated. It has been realized that application of the surface friction-reducing coating covering at least a portion of a surface of the implantable movement restriction device advantageously prevents or reduces the risk of migration of the implantable movement restriction device. During implantation, the surface friction-reducing coating maximizes contact with surrounding tissue and provides lubricity to the movement restriction device.

[0271] Typically, the surface friction-reducing coating covers at least 20%, such as at least 30%, for example at least 40%, for example at least 50%, for example at least 60%, for example at least 70%, for example at least 80%, for example at least 90%, for example at least 95% of the surface of the movement restriction device. According to one embodiment, the surface friction-reducing coating covers the entire surface of the movement restriction device. A higher degree of surface coverage is associated with a greater reduction in the risk of implantable movement restriction device migration.

[0272] In preferred embodiments, the surface friction-reducing coating is selected from natural polymers; polysaccharide coatings, oils, hydrogels, and lubricating jellies.

[0273] In certain embodiments, the surface friction-reducing coating comprises one or more natural polymers dissolved in water.Preferred natural polymers are selected from polysaccharides, such as native and modified cellulose, native and modified starch, xanthan gum, guar gum, carrageenan, alginate, pectin, and combinations thereof.Preferred polymers are methylcelluloses, such as hydroxypropylmethylcellulose (HPMC) and carboxymethylcellulose.Another preferred polymer is ethylcellulose, such as hydroxyethylcellulose.

[0274] One example of a useful hydrogel is poly(propylene fumarate-co-ethylene glycol) hydrogel.

[0275] In some embodiments, the surface friction-reducing coating is selected from racine oil, mineral oil, glycerin, and polyethylene glycol (PEG). A preferred component is PEG. It is even more preferable to use PEG with a larger molecular weight (>5 kDa) because it remains in the tissue for several days before being excreted.

[0276] The surface friction reducing coating may further comprise an active agent selected from a bactericide, an antibiotic, a bacteriostat, an analgesic, and an anesthetic.

[0277] Examples of bactericidal and bacteriostatic agents useful in friction-reducing coatings include antibiotics. Antibiotics are naturally occurring or synthetic substances used to kill or inhibit the growth of bacteria. Examples of antibiotics include penicillins (e.g., penicillin and amoxicillin), cephalosporins (e.g., cephalexin and cefuroxime), macrolides (e.g., erythromycin and azithromycin), and tetracyclines (e.g., tetracycline and azithromycin). These include tetracycline, doxycycline, and other quinolones (e.g., ciprofloxacin and levofloxacin), sulfonamides (e.g., sulfamethoxazole, trimethoprim), and aminoglycosides (e.g., gentamicin, tobramycin). Other examples of bactericidal and bacteriostatic agents useful in friction-reducing coatings include bacteriophages.

[0278] Examples of analgesics useful in surface friction-reducing coatings include anti-inflammatory analgesics (e.g., acetaminophen, aspirin, COX inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen) and opioids (e.g., codeine, fentanyl, hydrocodone, meperidine, methadone, naloxone, naltrexone, and oxycodone).

[0279] Examples of anesthetics useful in surface friction-reducing coatings include ester-based or amide-based local anesthetics. Examples of ester-based local anesthetics include procaine, amethocaine, cocaine, benzocaine, and tetracaine. Examples of amide-based local anesthetics include lidocaine, prilocaine, bupivacaine, levobupivacaine, ropivacaine, mepivacaine, dibucaine, and etidocaine. A preferred anesthetic is lidocaine, preferably at a concentration of 1-10% (w / v), e.g., 1-5% (w / v), e.g., 1-3% (w / v), e.g., about 2% (w / v).

[0280] In certain embodiments, the surface friction-reducing coating provides anti-corrosion properties to the movement restriction device.

[0281] The surface friction-reducing coating may also include pH-adjusting compounds such as weak acids, weak bases, buffers, and the like.

[0282] In some embodiments, the surface friction-reducing coating provides softening of the adjacent tissue, which can further prevent or reduce the risk of migration of the implantable movement restriction device.

[0283] In certain embodiments, the surface friction-reducing coating is a viscous medium. A viscous coating composition is a type of liquid or semi-solid material used to form a protective layer or film on a surface. This type of coating is characterized by a thick, tacky viscosity, which allows it to adhere to the surface and form a durable, long-lasting layer. There are many different types of viscous coatings, each with its own unique properties and characteristics.

[0284] The viscous medium is preferably a viscous aqueous medium, e.g., a viscous aqueous liquid such as a viscous aqueous solution. The viscous aqueous medium may be a viscoelastic medium. A preferred viscoelastic medium is a gel. The viscous medium may also be a viscous liquid.

[0285] Viscosity can be measured at 20°C using, for example, a shear rate controlled flow meter (Model 302, Anton Paar, Germany) with a parallel plate geometry (plate diameter 50 mm, gap 100 μm). In this setup, the viscosity of water is approximately constant at 1 mPa·s at shear rates between 0 and 100 s-1. For the avoidance of doubt, viscous media as defined herein are significantly more viscous than water. Viscous media as defined herein typically exhibit a viscosity of at least 10 mPa·s, e.g., at least 50 mPa·s, at shear rates between 0 and 100 s-1, e.g., 50 s-1. Preferably, viscous media as defined herein exhibit a viscosity of at least 100 mPa·s, e.g., at least 200 mPa·s, at shear rates between 0 and 100 s-1, e.g., 50 s-1. While the specific values ​​above relate to this particular setup, those skilled in the art can readily determine corresponding values ​​of viscosity in other experimental setups. Typically, the surface friction reducing coating has a viscosity higher than that of water.

[0286] The surface friction reducing coating may contain a preservative. Examples of preservatives include antimicrobial preservatives such as sorbic acid, parabens, and lactic acid. Preferred types of preservatives are parabens, such as methylparaben and propylparaben.

[0287] Preferably, the surface friction-reducing coating is configured to remain within a pouch for housing an implantable movement restriction device for a period of more than 7 days, preferably more than 14 days, such as more than 21 days or 28 days.

[0288] Examples of surface friction reducing coatings include: (1) Xylocaine jelly containing 0.1-10% (w / v) xylocaine (lidocaine hydrochloride). This composition also contains methylparaben, propylparaben, hydroxypropylmethylcellulose, and sodium hydroxide and / or hydrochloric acid to adjust the pH to 6.0-7.0. (2) A viscous xylocaine composition containing 0.1 to 10% (w / v) xylocaine (lidocaine hydrochloride). This composition also contains sodium carboxymethylcellulose, methylparaben, propylparaben, purified water, and saccharin sodium. (3) A surgical lubricant containing hydroxypropyl methylcellulose, propylene glycol, chlorhexidine gluconate, and sterile water. (4) Poly(propylene fumarate-co-ethylene glycol) hydrogel. (5) Polyethylene glycol (PEG) polymer, > 5 kDa (6) Lubricating glycerin jelly containing water, PEG, glycerin, carbomer, sodium hydroxide, methylparaben, and propylparaben. (7) Lidocaine jelly containing 0.1 to 10% (w / v) lidocaine hydrochloride. This composition also contains glycerol, hydrochloric acid, hydroxyethyl cellulose, sodium hydroxide, and water.

[0289] In some embodiments disclosed herein, the implantable movement restriction device has a size, as defined herein, such that the implantable movement restriction device can be completely invaginated by the patient's bottom wall. Preferably, the implantable movement restriction device has a size greater than 200 cm. 2 Less than 100cm, preferably 2 Less than 50cm, preferably 2 having a size of less than

[0290] In certain embodiments disclosed herein, the movement restriction device is elongate, with a first cross sectional distance having a first length and a second cross sectional distance having a second length, the first length being at least 1.2 times the second length, preferably at least 1.5 times the second length, and more preferably at least 2 times the second length.

[0291] In some embodiments disclosed herein, the implantable movement restriction device (100) comprises at least one circular cross-section. In certain embodiments, the implantable movement restriction device (100) comprises first, second, and third cross-sections in spaced-apart, parallel planes, the first and third cross-sections having the same area, and the second cross-section located between the first and third cross-sections and having a smaller area.

[0292] In certain embodiments disclosed herein, the implantable movement restriction device comprises at least two components, or at least three components, or at least four components. Optionally, the at least two components are configured to be assembled to form the implantable movement restriction device. Further optionally, the at least two components are configured to be connected to each other to form the implantable movement restriction device.

[0293] In some embodiments disclosed herein, the movement restriction device has a curved cross-section in a plane parallel to the patient's transverse plane, the curved portion configured to partially surround the patient's esophagus. Advantageously, the movement restriction device is configured to surround at least one-third of the esophagus in a plane parallel to the patient's transverse plane, preferably at least one-half of the esophagus in a plane parallel to the patient's transverse plane. In certain embodiments disclosed herein, the movement restriction device comprises a C-shaped cross-section in a plane parallel to the patient's transverse plane, the C-shaped cross-section configured to partially surround the patient's esophagus. Optionally, the movement restriction device is configured to surround at least two-thirds of the esophagus in a plane parallel to the patient's transverse plane. In a specific embodiment, the cross-section of the movement restriction device in a plane parallel to the patient's transverse plane comprises a closed curve configured to surround the patient's esophagus.

[0294] In some embodiments disclosed herein, the implantable movement restriction device (100) comprises at least one circular cross-section.

[0295] According to a related aspect, there is also provided a method of treating reflux disease in a human patient by implanting a movement restriction device (100), the method comprising at least partially invaginating the movement restriction device into the patient's stomach such that the movement restriction device restricts movement of a cardia (22) of the patient's stomach (10) toward the thoracic diaphragm (30) to prevent the cardia from sliding through the diaphragmatic opening (32) into the patient's thoracic cavity, the surface of the movement restriction device being at least partially covered by a surface friction-reducing coating.

[0296] Further provided is a friction reducing composition for use in the method defined herein as a surface friction reducing coating.

[0297] Also provided is the use of a composition selected from natural polymers, polysaccharide coatings, oils, hydrogels, and lubricating jellies as a surface friction-reducing coating on at least a portion of the surface of an implantable movement restriction device for treating reflux disease in a human patient, wherein the movement restriction device (100) is configured to be at least partially invaginated by the patient's stomach wall and positioned to restrict movement of the cardia (22) of the patient's stomach (10) toward the diaphragm (30) to prevent the cardia from sliding through the diaphragmatic opening (32) into the patient's thoracic cavity.

[0298] During implantation, the surface friction-reducing coating maximizes contact with the surrounding tissue and provides lubricity to the movement restriction device.

[0299] In certain embodiments, the method includes applying a surface friction-reducing coating onto the movement restriction device prior to implantation within the patient, meaning that the coating is applied ex vivo. In other embodiments, the method includes applying a surface friction-reducing coating in situ between the movement restriction device and tissue of the patient's stomach wall.

[0300] In some embodiments, the method comprises: - partially invaginating a migration restriction device within the patient's stomach; applying a surface friction-reducing coating in situ between the movement restriction device and tissue of the patient's stomach wall; - further invaginating the migration restriction device within the patient's stomach; Includes:

[0301] Optionally, the step of at least partially invaginating the movement restriction device within the patient's stomach comprises completely invaginating the movement restriction device within the patient's stomach.

[0302] In certain embodiments, the method is a laparoscopic surgical method, and the method further comprises introducing the movement restriction device into the patient through a laparoscopic trocar after the surface friction-reducing coating has been applied.

[0303] In another embodiment, the method is a laparoscopic surgical method, and the step of applying in situ a surface friction-reducing coating between the movement restriction device and tissue of the patient's stomach wall includes applying the surface friction-reducing coating in situ using a laparoscopic instrument inserted into the patient through a laparoscopic trocar.

[0304] In some embodiments, the method is a gastroscopy procedure, and the method further comprises introducing the movement restriction device into the patient through the patient's esophagus after the surface friction-reducing coating has been applied.

[0305] In certain embodiments, the method is a gastroscopy procedure, and the step of applying in situ a surface friction-reducing coating between the movement restriction device and tissue of the patient's stomach wall comprises applying the surface friction-reducing coating in situ using a gastroscopy instrument inserted into the patient's body via the esophagus.

[0306] Typically, the surface friction-reducing coating covers at least 20%, such as at least 30%, for example at least 40%, for example at least 50%, for example at least 60%, for example at least 70%, for example at least 80%, for example at least 90%, for example at least 95% of the surface of the movement restriction device. According to one embodiment, the surface friction-reducing coating covers the entire surface of the movement restriction device. The higher the degree of surface coverage, the more the risk of migration of the implantable movement restriction device is reduced.

[0307] In some embodiments, the step of at least partially invaginating the movement restriction device comprises at least partially invaginating a movement restriction device that includes a surface friction-reducing coating covering an entire surface of the movement restriction device.

[0308] In a preferred embodiment, the step of at least partially invaginating the movement restriction device comprises at least partially invaginating the movement restriction device with a surface friction-reducing coating selected from a natural polymer, a polysaccharide coating, an oil, a hydrogel, and a lubricating jelly.

[0309] In certain embodiments, the surface friction-reducing coating comprises one or more natural polymers dissolved in water.Preferred natural polymers are selected from polysaccharides, such as native and modified cellulose, native and modified starch, xanthan gum, guar gum, carrageenan, alginate, pectin, and combinations thereof.Preferred polymers are methylcelluloses, such as hydroxypropylmethylcellulose (HPMC) and carboxymethylcellulose.Another preferred polymer is ethylcellulose, such as hydroxyethylcellulose.

[0310] One example of a useful hydrogel is poly(propylene fumarate-co-ethylene glycol) hydrogel.

[0311] In some embodiments, the surface friction-reducing coating is selected from lacquer oil, mineral oil, glycerin, and polyethylene glycol (PEG). A preferred agent is PEG. It is even more preferred to use PEG with a higher molecular weight (>5 kDa).

[0312] The surface friction reducing coating may further comprise an active agent selected from a bactericide, an antibiotic, a bacteriostat, an analgesic, and an anesthetic.

[0313] Examples of bactericidal and bacteriostatic agents useful in friction-reducing coatings include antibiotics. Antibiotics are naturally occurring or synthetic substances used to kill or inhibit the growth of bacteria. Examples of antibiotics include penicillins (e.g., penicillin and amoxicillin), cephalosporins (e.g., cephalexin and cefuroxime), macrolides (e.g., erythromycin and azithromycin), tetracyclines (e.g., tetracycline, doxycycline, etc.), quinolones (e.g., ciprofloxacin, levofloxacin, etc.), sulfonamides (e.g., sulfamethoxazole, trimethoprim, etc.), and aminoglycosides (e.g., gentamicin, tobramycin, etc.). Other examples of bactericidal and bacteriostatic agents useful in friction-reducing coatings include bacteriophages.

[0314] Examples of analgesics useful in surface friction-reducing coatings include anti-inflammatory analgesics (e.g., acetaminophen, aspirin, COX inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen) and opioids (e.g., codeine, fentanyl, hydrocodone, meperidine, methadone, naloxone, naltrexone, and oxycodone).

[0315] Examples of anesthetics useful in surface friction-reducing coatings include ester-based or amide-based local anesthetics. Examples of ester-based local anesthetics include procaine, amethocaine, cocaine, benzocaine, and tetracaine. Examples of amide-based local anesthetics include lidocaine, prilocaine, bupivacaine, levobupivacaine, ropivacaine, mepivacaine, dibucaine, and etidocaine. A preferred anesthetic is lidocaine, preferably at a concentration of 1-10% (w / v), e.g., 1-5% (w / v), e.g., 1-3% (w / v), e.g., about 2% (w / v).

[0316] In certain embodiments, the surface friction-reducing coating provides anti-corrosion properties to the movement restriction device.

[0317] The surface friction-reducing coating may also include pH-adjusting compounds such as weak acids, weak bases, buffers, and the like.

[0318] In some embodiments, the surface friction-reducing coating contributes to softening of the adjacent tissue, which can further prevent or reduce the risk of migration of the implantable movement restriction device.

[0319] In certain embodiments, the surface friction-reducing coating is a viscous medium. A viscous coating composition is a type of liquid or semi-solid material used to form a protective layer or film on a surface. This type of coating is characterized by a thick, tacky viscosity, which allows the coating to adhere to the surface and form a durable, long-lasting layer. There are many different types of viscous coatings, each with its own unique properties and characteristics.

[0320] The viscous medium is preferably a viscous aqueous medium, such as a viscous aqueous solution. The viscous aqueous medium may be a viscoelastic medium. A preferred viscoelastic medium is a gel. The viscous medium may also be a viscous liquid.

[0321] Viscosity can be measured, for example, at 20°C using a shear rate-controlled rheometer (Model 302, Anton Paar, Germany) in parallel plate geometry (plate diameter 50 mm, gap 100 μm). In this setup, the viscosity of water is approximately constant at 1 mPa·s between shear rates of 0 and 100 s-1. For the avoidance of doubt, a viscous medium as defined herein is significantly more viscous than water. A viscous medium as defined herein typically exhibits a viscosity of at least 10 mPa·s, e.g., at least 50 mPa·s, at shear rates between 0 and 100 s-1, e.g., 50 s-1. Preferably, a viscous medium as defined herein exhibits a viscosity of at least 100 mPa·s, e.g., at least 200 mPa·s, at shear rates between 0 and 100 s-1, e.g., 50 s-1. While the specific values ​​above relate to this particular setup, those skilled in the art can readily determine corresponding values ​​of viscosity in other experimental setups. Typically, the surface friction reducing coating has a viscosity higher than that of water.

[0322] The surface friction reducing coating may contain a preservative. Examples of preservatives include antimicrobial preservatives such as sorbic acid, parabens, and lactic acid. Preferred types of preservatives are parabens, such as methylparaben and propylparaben.

[0323] Preferably, the surface friction-reducing coating is configured to remain within a pouch for housing an implantable movement restriction device for a period of more than 7 days, preferably more than 14 days, such as more than 21 days or 28 days.

[0324] Examples of surface friction reducing coatings include: (1) Xylocaine jelly containing 0.1-10% (w / v) xylocaine (lidocaine hydrochloride). This composition also contains methylparaben, propylparaben, hydroxypropylmethylcellulose, and sodium hydroxide and / or hydrochloric acid to adjust the pH to 6.0-7.0. (2) A viscous xylocaine composition containing 0.1 to 10% (w / v) xylocaine (lidocaine hydrochloride), which also contains sodium carboxymethylcellulose, methylparaben, propylparaben, purified water, and saccharin sodium. (3) A surgical lubricant containing hydroxypropyl methylcellulose, propylene glycol, chlorhexidine gluconate, and sterile water. (4) Poly(propylene fumarate-co-ethylene glycol) hydrogel (5) Polyethylene glycol (PEG) polymer, > 5 kDa (6) Lubricating glycerin jelly containing water, PEG, glycerin, carbomer, sodium hydroxide, methylparaben, and propylparaben. (7) Lidocaine jelly containing 0.1 to 10% (w / v) lidocaine hydrochloride. The composition also contains glycerol, hydrochloric acid, hydroxyethyl cellulose, sodium hydroxide, and water.

[0325] In some embodiments disclosed herein, the implantable movement restriction device has a size, as defined herein, such that the implantable movement restriction device can be completely invaginated by the patient's bottom wall. Preferably, the implantable movement restriction device has a size greater than 200 cm. 2 , preferably 100 cm 2 Less than 50cm, preferably 2 The step of at least partially invaginating the movement restriction device may include at least partially invaginating a movement restriction device having a size such that the implantable movement restriction device can be completely invaginated by the patient's bottom wall. Preferably, the step of at least partially invaginating the movement restriction device has an area of ​​less than 200 cm, preferably less than 100 cm. 2 Less than 50cm, preferably 2 at least partially invaginating a movement restriction device having a size less than the

[0326] In some embodiments, the step of at least partially invaginating the movement restriction device comprises at least partially invaginating an elongated movement restriction device having a first cross-sectional distance with a first length and a second cross-sectional distance with a second length, wherein the first length is not less than 1.2 times the second length, preferably not less than 1.5 times the second length, and more preferably not less than 2 times the second length.

[0327] In certain embodiments, the step of at least partially invaginating the movement restriction device includes at least partially invaginating a movement restriction device that includes at least one circular cross-section.

[0328] In some embodiments, the step of at least partially invaginating the movement restriction device comprises at least partially invaginating the movement restriction device including first, second and third cross sections in spaced-apart parallel planes, the first and third cross sections having the same area, and the second cross section being located between the first and third cross sections and having a smaller area.

[0329] In certain embodiments, the step of at least partially invaginating the movement restriction device comprises at least partially invaginating a movement restriction device comprising at least two sections, or at least three sections, or at least four sections. Preferably, the step of at least partially invaginating the movement restriction device comprises assembling at least two parts to form the implantable movement restriction device.

[0330] In some embodiments, the step of at least partially invaginating the movement restriction device comprises at least partially invaginating a movement restriction device that includes a curved cross-section in a plane parallel to a transverse plane of the patient, the curved portion configured to partially surround the patient's esophagus.

[0331] In certain embodiments, the step of at least partially invaginating the movement restriction device includes at least partially invaginating a movement restriction device that includes at least one circular cross-section.

[0332] According to one aspect, an apparatus for treating reflux disease in a human patient is provided, the apparatus comprising an implantable movement restriction device and an electrode array. The implantable movement restriction device has a shape and size that allows it to be positioned to rest against a fundus wall portion of the patient's stomach and be at least partially invaginated by the fundus wall portion, the movement restriction device being implanted at a position between the patient's diaphragm and a lower portion of the fundus wall so as to restrict movement of the cardia of the patient's stomach toward the diaphragm and prevent the cardia from sliding through an opening in the diaphragm and into the patient's rib cage. The electrode array is positioned between the movement restriction device and the fundus wall portion and is configured to engage and electrically stimulate muscle tissue in the fundus wall portion to cause muscle tissue movement and improve long-term implantation conditions of the movement restriction device.

[0333] According to one aspect, an apparatus for treating reflux disease in a human patient is provided, the apparatus comprising: an implantable movement restriction device having at least a portion thereof formed as a ring; and an electrode array. The implantable movement restriction device comprises a first portion configured to be at least partially invaginated by a first wall portion of the patient's stomach, the first portion being positioned such that at least a portion of the first portion is positioned above a cardiac notch of the patient's stomach, the first portion being configured to restrict movement of the cardia toward the diaphragm to prevent the cardia from sliding through the diaphragmatic opening into the patient's thorax. The electrode array is positioned between the movement restriction device and the first wall portion and configured to electrically stimulate muscle tissue in the first wall portion to cause muscle tissue movement and improve long-term implant conditions of the movement restriction device.

[0334] According to one aspect, a device for treating reflux disease in a human patient is provided, the device comprising an elongate core and a tubular covering. The elongate core has a length that enables the core to at least partially surround the patient's esophagus, the length being variable to enable the core to be disposed in a contracted state for preventing the passage of fluid from the stomach to the esophagus and an expanded state for allowing the passage of food to the stomach in response to the patient's swallowing. The tubular covering is configured to surround at least a portion of the core and includes a plurality of portions adapted to flex relative to one another when the covering is at least partially covered by fibrous tissue to enable the core to change between the contracted state and the expanded state without being substantially hindered or inhibited by the presence of the fibrous tissue.

[0335] According to one aspect, a device for treating reflux disease in a human patient is provided, the device comprising an elongated core having a length that enables the core to at least partially surround the patient's esophagus, the length being variable to enable the core to be positioned in a contracted state for preventing the passage of fluid from the stomach to the esophagus and an expanded state for allowing the passage of food to the stomach in response to the patient's swallowing. The device further comprises an electrode array supported by the core and positioned between the device and the esophagus, the electrode array including electrode elements configured to electrically stimulate esophageal musculature.

[0336] According to one aspect, there is provided a device for treating reflux disease in a human patient, the device comprising a tubular device having a length that allows the device to at least partially surround the patient's esophagus, the tubular covering having a length that is variable to allow the device to be positioned in a contracted state to prevent fluid from passing from the stomach to the esophagus and an expanded state to allow food to pass to the stomach in response to the patient swallowing. An outer surface of the tubular device may include a plurality of portions adapted to flex relative to one another when the outer surface is at least partially covered with fibrous tissue to allow the tubular device to change between the contracted state and the expanded state without being substantially impeded or obstructed by the presence of said fibrous tissue.

[0337] According to one aspect, a device for treating reflux disease in a human patient is provided, the device comprising an elongated core having a length that allows the core to at least partially encircle the patient's esophagus. The length may be variable so that the core can be positioned in a contracted state to prevent the passage of fluid from the stomach to the esophagus and an expanded state to allow the passage of food to the stomach in response to the patient's swallowing. Furthermore, the elongated core has a size that allows at least a portion of the elongated core to protrude above the patient's sphincter when implanted, thereby restricting movement of the cardia toward the diaphragm and preventing the cardia from sliding through the diaphragmatic opening into the patient's rib cage.

[0338] According to one aspect, a device for treating reflux disease in a human patient is provided, the device adapted to at least partially surround the patient's esophagus (20). The device includes a first implantable portion and a second implantable portion, the first implantable portion having a shape and size that allows it to be positioned to rest against and be at least partially invaginated by a fundus wall portion of the patient's stomach. The first implantable portion is implanted at a position between the patient's diaphragm and a lower portion of the fundus wall of the stomach, restricting movement of the patient's gastric cardia toward the diaphragm to prevent the gastric cardia from sliding through an opening in the diaphragm and into the patient's thorax. The second implantable portion is elongated to at least partially surround the esophagus and has a variable length that allows the device to be positioned in a contracted state to prevent the passage of fluid from the stomach to the esophagus and an expanded state to allow the passage of food into the stomach in response to the patient's swallowing.

[0339] According to one aspect, a device for treating reflux disease in a human patient is provided, the device adapted to at least partially surround the patient's esophagus. The device includes a movement restriction device, an elongated support device, and an electrode array. The movement restriction device has a shape and size that allows it to be positioned to rest against and be at least partially invaginated by a fundus wall portion of the patient's stomach, and a first implantable portion is implanted at a position between the patient's diaphragm and a lower portion of the fundus wall, restricting movement of the patient's stomach cardia toward the diaphragm and preventing the cardia from sliding through an opening in the diaphragm and into the patient's thorax. The elongated support device is connected to the movement restriction device and configured to at least partially surround the esophagus. The electrode array includes electrode elements supported by the support device and configured to electrically stimulate esophageal musculature. Furthermore, the support device has a rigidity such that the position of the electrode elements relative to the esophagus is primarily determined by the position and orientation of the movement restriction device.

[0340] According to one embodiment, a method of treating reflux disease in a human patient is provided. The method includes implanting a movement restriction device positioned to restrict movement of the cardia of the patient's stomach toward the diaphragm and prevent the cardia from sliding through an opening in the diaphragm and into the patient's rib cage. The method also includes positioning the movement restriction device so that a lower portion of the movement restriction device abuts the serosa at the angle of His, and an upper portion of the movement restriction device abuts the angle of His to define a gap between the movement restriction device and the patient's esophagus. The method further includes positioning a portion of a gastric fundus in the gap and attaching the gastric fundus to the patient's esophagus so that the portion of the gastric fundus at least partially surrounds the movement restriction device.

[0341] According to one aspect, an apparatus for treating reflux disease in a human patient is provided, the apparatus comprising: an implantable movement restriction device; and an elongated attacher attached to the movement restriction device and configured to be at least partially invaginated by a wall of the patient's stomach. The attacher is shaped and sized to be able to bite into the wall to prevent rotation of the movement restriction device. The attacher is further configured to be invaginated by the wall so as to position the movement restriction device between the patient's diaphragm and the wall, away from the patient's esophagus, and to restrict movement of the cardia of the patient's stomach toward the diaphragm and prevent the cardia from sliding through the diaphragmatic opening into the patient's thorax.

[0342] According to one aspect, a device for treating reflux disease in a human patient includes an implantable at least partially ring-shaped movement restriction device configured to have a first lower portion of the movement restriction device positioned at the cardia of the patient's stomach and a second upper portion of the movement restriction device positioned against the patient's diaphragm, restricting movement of the cardia toward the diaphragm to prevent the cardia from sliding through an opening in the diaphragm and into the patient's thorax. The device is further configured to be positioned to define a gap or spacing between the second upper portion of the movement restriction device and the exterior of the esophagus when the device is implanted. The device may be formed of or may include at least a movement restriction device as disclosed herein.

[0343] According to one aspect, a method of treating reflux disease in a human patient is provided, comprising implanting a device including a movement restriction device and an elongated support device, wherein the support device at least partially surrounds the patient's esophagus, and the movement restriction device is positioned on the fundus side of the esophagus to restrict movement of the cardia relative to the diaphragm and prevent the cardia from sliding through the diaphragmatic opening and into the patient's thorax. The method includes the steps of introducing the device into the abdominal cavity, positioning the device so that the movement restriction device abuts the outside of the fundus, wrapping a portion of the fundus around at least a portion of the movement restriction device, and securing the fundus to the diaphragm, affixing the fundus to the esophagus and positioning the support device to at least partially surround the esophagus so that the movement restriction device is positioned between the diaphragm and the sphincter and a portion of the fundus is positioned between the movement restriction device and the esophagus, and the movement restriction device and the second portion form a ring-shaped body extending through the pouch to at least partially surround the esophagus.

[0344] According to one aspect, a method of affixing a fundus portion of a human patient's stomach to the patient's esophagus is provided, wherein the fundus portion extends from the angle of His away from the esophagus. The method includes folding the fundus upward along the esophagus from the angle of His so that the fundus rests relative to the esophagus, and affixing the fundus to the esophagus with fasteners positioned along first and second lines. The first and second lines extend along the esophagus and are positioned such that the distance between the first and second lines increases with increasing distance from the angle of His.

[0345] According to one aspect, there is provided a device for treating reflux disease in a human patient according to any of the above aspects, the device comprising an electrode array for electrically stimulating muscle tissue in the patient to exercise the muscle tissue and improve the long-term implant condition of the device, as generally described above, the device further comprising an implantable energy source configured to provide power to the electrode array, and a controller operably connected to the electrode array for controlling the electrical stimulation of the muscle tissue.

[0346] According to an aspect, there is provided a device for treating reflux disease in a human patient according to any one of the aspects above, comprising: an electrode array; an implantable energy source configured to power the device; an external energy source positioned outside the patient's body and configured to supply energy to the implantable energy source; and an implantable charger electrically connected to the implantable energy source and configured to allow charging of the implantable energy source by the external energy source.

[0347] According to one aspect, an apparatus for treating reflux disease in a human patient comprises an implantable movement restriction device having a shape and size that allows it to be positioned to rest against a fundus wall portion of the patient's stomach (10), the movement restriction device being implanted at a position between the patient's diaphragm (30) and a portion of the fundus wall to restrict movement of a cardia (22) of the patient's stomach toward the diaphragm to prevent the cardia from sliding through an opening in the diaphragm and into the patient's thoracic cavity, the implantable movement restriction device having an outer surface configured to rest against the stomach wall portion, the outer surface having an average surface roughness of 0.5 μm or less measured. A device for treating reflux disease in a human patient is provided.

[0348] According to one aspect, there is provided an apparatus for treating reflux disease in a human patient, comprising: an implantable movement restriction device having a shape and size that enables it to be positioned to rest against a portion of a fundus wall of the patient's stomach, the movement restriction device being implanted at a position between the patient's diaphragm and a portion of the fundus wall so as to restrict movement of a cardia of the patient's stomach toward the diaphragm to prevent the cardia from sliding through an opening in the diaphragm and into the patient's thoracic cavity, the implantable movement restriction device having an outer surface configured to rest against the portion of the stomach wall, the implantable movement restriction device having an indentation hardness measured on the outer surface of at least 50 on the Shore A scale.

[0349] According to one aspect, an apparatus for treating reflux disease in a human patient comprises an implantable movement restriction device having a shape and size that allows it to be positioned to rest against a portion of a fundus wall of the patient's stomach, the movement restriction device being implanted at a position between the patient's diaphragm and a portion of the fundus wall such that movement of the cardia of the patient's stomach toward the diaphragm is restricted to prevent the cardia from sliding through an opening in the diaphragm and into the patient's thoracic cavity, the implantable movement restriction device comprising a plurality of segments, the plurality of segments comprising a core portion and a plurality of outer portions, the core portion having a resistance to 1000 kg / m 3 A device for treating reflux disease in a human patient is provided having an average density greater than

[0350] According to one embodiment, there is provided an apparatus for treating reflux disease in a human patient according to any one of the above aspects, the apparatus comprising: an electrode array; and a controller configured to operatively connect to the electrode array to control electrical stimulation of muscle tissue, the controller comprising an implantable communicator for transmitting and / or receiving signals to and from outside the patient's body.

[0351] According to one embodiment of the above aspect, the electrode array may be disposed on an outer surface of the movement restriction device.

[0352] According to some embodiments of the above aspect, the electrode array may include a plurality of electrode elements, each configured to engage and electrically stimulate muscle tissue, and may further include a coiled wire to increase the contact area between the electrode array and the muscle tissue and enable the electrode array to follow the contraction and relaxation of the muscle tissue.

[0353] According to some embodiments of the above aspects, the electrode array may include bare electrode portions configured to form a metal-tissue interface with the muscle tissue to enable faradaic charge transfer as the predominant charge transfer mechanism at the interface. Alternatively, or additionally, the electrode array may include electrode portions at least partially covered by a dielectric material configured to form a dielectric-tissue interface with the muscle tissue to reduce the faradaic portion of the charge transfer mechanism at the interface.

[0354] According to some embodiments, the electrode array may be configured to be positioned to electrically stimulate the sphincter muscle to cause it to contract. The electrode array may include at least two electrode elements configured to be positioned on opposite sides of the sphincter muscle. Further, the device may include a holder configured to support the at least two electrode elements on opposite sides of the sphincter muscle.

[0355] Exemplary embodiments of movement restriction devices according to at least some of the above aspects will now be described.

[0356] According to one embodiment, the volume of the movement restriction device may not be adjustable after implantation. According to another embodiment, the volume of the movement restriction device may be adjustable after implantation. The volume may be adjustable invasively or non-invasively. In one example, the movement restriction device includes an injection port to allow fluid to be injected or extracted from within the movement restriction device to change the volume of the movement restriction device after implantation.

[0357] According to one embodiment, the movement restriction device may comprise a biocompatible outer surface configured to rest against the fundus wall portion.

[0358] According to one embodiment, the movement restriction device may be substantially spherical or ovoid. In one example, the movement restriction device may have a portion configured to be positioned away from the esophagus when implanted. In a further example, a lower portion of the movement restriction device may be wider than an upper portion.

[0359] According to one embodiment, the movement restriction device may be configured to invaginate when placed on the outside of the fundus wall, hi another embodiment, the movement restriction device may be configured to invaginate when placed on the inside of the fundus wall.

[0360] According to one embodiment, the movement restriction device can be configured to be introduced into a patient's body by a gastroscope or an intraluminal device. The movement restriction device can be configured to change shape during insertion into a patient's body, for example, to allow it to pass through a trocar.

[0361] According to one embodiment, the movement restriction device may be formed from at least two separate separable parts that are configured to be assembled into a movement restriction device after insertion into a patient's body.

[0362] According to an embodiment the minimum width of the movement restriction device may be, measured from side to side, 20mm or more, such as 30mm or more, such as 40mm or more, such as 50mm or more.

[0363] According to some embodiments, the movement restriction device may include a first portion and a second portion, the first portion and the second portion configured to be positioned on opposite sides of the cardia. In one example, the movement restriction device may be configured to be positioned such that a gap is formed between the second portion of the movement restriction device and the esophagus. In one example, the second portion of the movement restriction device may be configured to be at least partially invaginated by a second wall of the stomach.

[0364] According to one embodiment, the movement restriction device may be configured to be positioned such that a portion of the first wall is positioned between the first portion of the movement restriction device and the esophagus.

[0365] According to one embodiment, the movement limiting device may be configured to be at least partially invaginated by the first wall along at least half of the toroidal length of the movement limiting device.

[0366] According to one embodiment, the movement restriction device can be configured to be indented when placed outside the stomach wall.

[0367] According to one embodiment, the movement restriction device may comprise two ends configured to be joined together to form a closed ring. The ends may be configured to be releasably attached to one another.

[0368] According to an embodiment, the poloidal circumference of the movement restriction device may be greater in the first portion than in the second portion. In one example, the first portion of the movement restriction device has a minimum width, measured from side to side, of 20 mm or more, such as 30 mm or more, such as 40 mm or more, for example 50 mm or more. Alternatively, the width may be defined as the height measured along a normal to the plane in which the circumference extends.

[0369] According to one embodiment, the movement limiter may have a shape that fits into a torus.

[0370] According to one embodiment, the movement restriction device may have a C-shaped cross section.

[0371] According to one embodiment, the top of the movement restrictor may comprise a recess defined in the outer surface of the movement restrictor.

[0372] According to one embodiment, the lower portion of the movement restriction device may include a curved outer surface positioned to face the esophagus, the curved outer surface may include a radius of curvature that corresponds to or exceeds the radius of curvature of the esophagus.

[0373] According to embodiments, an elongate support protruding from the movement restriction device may be at least partially invaginated into the fundus before the fundus is attached to the esophagus, and may be oriented along the esophagus.

[0374] Exemplary embodiments of a core and cover according to at least some of the above aspects will now be described.

[0375] According to some embodiments, the core may be configured to allow a transition from a contracted state to an expanded state caused by food passing through the esophagus, and the core may be configured to exert an enveloping pressure on the esophagus in the contracted state.

[0376] According to one embodiment, the device may further include an attractor for elastically attracting adjacent portions of the core toward one another to generate an enveloping pressure. The attractor may include an elastic element and / or at least two mutually attracting magnets. The device may further include a link connecting a first magnet and a second magnet of the at least two magnets to one another. The link may be configured to extend into at least one of the magnets in response to the magnets moving toward one another.

[0377] According to some embodiments, the core may include two end portions configured to be joined together to form a closed ring around the esophagus. The end portions may be configured to be releasably attached to each other and may include respective interlocking attachments.

[0378] According to one embodiment, the core may include a plurality of core elements configured to be arranged annularly around the esophagus. The core may further include a plurality of links, each extending between a respective pair of core elements positioned adjacent to one another. The links may be configured to allow the respective core elements to move toward and away from one another and may be configured to extend into at least one of the core elements of a respective pair of core elements as the core elements move toward one another.

[0379] According to one embodiment, the cover may be comprised of an array of tubular segments.

[0380] According to some embodiments, the cover may include a biocompatible outer surface for long-term implantation. The cover may be configured to rest against the outer surface of the esophagus, for example, and may further include a surface for promoting tissue growth. The cover may be formed of a polymeric material, such as silicone. In a further example, the cover may be formed of or comprised of a carbon-based material, such as a carbon fiber material.

[0381] According to some embodiments, the cover may be formed of a material having a thickness of 0.1 to 10 mm, e.g., 1 to 5 mm. The cover may include at least one predefined fold that allows the cover to fold in response to the core changing its length. In some examples, the cover may have lowered and raised portions that allow the cover to change its length while maintaining its surface area. Thus, the cover may be configured to be compressible and expandable along its length, with the length changing primarily due to the folding of the cover rather than the elastic properties of the material. Thus, the cover may be considered to be formed of a non-elastic material. In some examples, the length of the cover surrounding at least a portion of the core may exceed the length of at least a portion of the core when at least a portion of the core is disposed in a contracted state.

[0382] Next, as described above in connection with some aspects, an exemplary embodiment of an attacher having a shape and size that allows it to be contained by a wall to prevent rotation of the movement restriction device will be described below.

[0383] According to some embodiments, the first end of the attacher may be configured to be recessed by a wall, and the second end may be configured to be attached to a movement restriction device. The first and second portions may extend in different directions relative to each other, and the first portion may be configured to be recessed by the wall to prevent rotation of the movement restriction device about a first axis, and the second portion may be configured to be recessed by the wall to prevent rotation of the movement restriction device about a second axis different from the first axis. The first and second portions of the attacher may be curved to follow the curvature of the wall. The first and second portions may be disposed at an angle to each other, the angle being between 60 and 120 degrees, for example, 90 degrees.

[0384] According to some embodiments, the attacher may be configured to be releasably attached to the movement limiting device. The attacher may be configured to allow the position of the movement limiting device to be adjusted after the attachment means has collapsed. In some examples, the device may be configured to allow the distance between the movement limiting device and the attacher to be changed so that the position of the movement limiting device relative to the diaphragm can be adjusted. Furthermore, the device may be configured to allow the orientation of the movement limiting device relative to the attachment means to be changed so that the position of the movement limiting device relative to the diaphragm can be adjusted.

[0385] In one embodiment, the attacher may include a third portion configured to protrude from the wall when implanted and to define a distance between the wall and the movement restriction device. The third portion may include a curvature that enables the third portion to be positioned away from the esophagus when implanted.

[0386] According to one embodiment, the movement limiting device and the attacher may be integrally formed.

[0387] According to one embodiment, the movement restriction device and attachment means may each have a biocompatible outer surface. The attacher may include an outer surface configured to promote tissue growth. In some examples, the attacher may be formed of a metal. In a further example, the movement restriction device may be formed of a polymer.

[0388] According to one embodiment, the outer surface of the movement restriction device can be made of a material to prevent the growth of fibrous tissue.

[0389] Next, an exemplary embodiment of a method for treating reflux disease in a human patient by implanting a device including a movement restriction device and an elongate support device, as described in some aspects above, will be described below.

[0390] According to one embodiment, the device can be positioned so that the movement restriction device rests against the outside of the fundus, at a location between the sphincter and the portion that is anchored to the esophagus.

[0391] According to one embodiment, the device can be positioned such that the portion of the fundus anchored to the esophagus is positioned between the sphincter and the migration restriction device.

[0392] According to one embodiment, the pouch can be configured to open in at least two positions to form a tunnel through which the device extends.

[0393] According to one embodiment, a portion of the fundus may be affixed to the patient's diaphragm.

[0394] According to one embodiment, securing a portion of the fundus to the esophagus may include suturing or stapling.

[0395] According to one embodiment, the support device may have a first end and a second end that are introducible into the esophagus, and the first and second ends may be coupled together to annularly secure the support device in the esophagus.

[0396] According to one embodiment, the method further includes inserting a needle or tubular device into the patient's abdomen; filling the abdomen with gas using the needle or tubular device; positioning at least two laparoscopic trocars in the abdomen; inserting a camera into the abdomen through one of the laparoscopic trocars; inserting at least one dissection device through one of the laparoscopic trocars; dissecting a portion of the stomach; and at least partially closing the pouch with sutures, such as barbed sutures, or staples.

[0397] In the following, an exemplary embodiment of a method for affixing a gastric fundus of a human patient to the patient's esophagus according to the above aspects is described.

[0398] According to one embodiment, the abdominal esophagus and the fundus of the stomach can be divided into a ventral and a dorsal plane. The method comprises creating a first line on the dorsal side of the plane and a second line on the ventral side. The first line begins 1 cm above the angle of His, and the second line begins 3 cm above the angle of His. In some instances, the second line begins less than 2 cm from the first line.

[0399] According to one embodiment, the separation angle between the first line and the second line may be in the range of 90 to 150 degrees.

[0400] According to some embodiments, the method may include providing an additional fastener between the first line and the second line at the top of the fundus.

[0401] In some instances, the fasteners may include staples. In some instances, the fasteners may comprise sutures, such as barbed sutures. The first line of fasteners may comprise, for example, a first running suture, and the second line of fasteners may comprise, for example, a second running suture.

[0402] According to some embodiments, the method may further include placing a movement restriction device in the fundus of the stomach, forming a pouch in the fundus, at least partially placing the movement restriction device in the pouch, and invaginating the movement restriction device into the fundus of the stomach by at least partially closing the pouch with a fastener. The movement restriction device may be positioned at a position between the diaphragm and the sphincter and may prevent the cardia from sliding through the diaphragmatic opening into the patient's thorax. The movement restriction device may also be inserted after the fundus of the stomach is secured to the esophagus. The pouch may also be formed with at least two openings to form a tunnel through which the movement restriction device extends. As an example, the fundus of the stomach may be secured to the diaphragm.

[0403] According to some embodiments, an energy source may be provided. The energy source may be configured to be implanted within the patient's body. The energy source may be configured to power energy-consuming components of the implant. Examples of energy-consuming components include controllers, sensors, electrodes, etc., as outlined above in connection with the previous embodiments and examples. Thus, in some embodiments, the energy source may be configured to power an electrode array, i.e., electrodes, as outlined above.

[0404] The implantable energy source may be configured to be disposed within or integrated with an implantable device, such as a movement restriction device, support device, attachment means, core, or cover, according to any of the embodiments and examples described above. In some examples, the energy source, or a portion of the energy source, may be configured to be implanted externally to the device or implantable device, for example, subcutaneously.

[0405] The energy source may comprise a primary battery (galvanic battery) that is designed to be discarded after use and not recharged like a secondary battery. Alternatively, or additionally, the energy source may comprise a secondary battery (rechargeable battery) that is designed to be repeatedly charged.

[0406] According to some embodiments, the implantable energy source can be configured to be charged by an external energy source, i.e., an energy source located outside the patient's body. This can be accomplished, for example, by an implantable charger that is electrically connected to the implantable energy source and configured to allow charging of the implantable energy source by the external energy source. Thus, the charger can be configured to transfer power from outside the patient's body to the implantable energy source. Power transfer can be performed wirelessly, for example, from the external energy source, and the charger, in some examples, can include an electromagnetic coil to facilitate power transfer.

[0407] According to some embodiments, the charger may be configured to control charging of the implantable energy source by controlling the reception of power from the external energy source at the implantable charger and / or by controlling the transmission of power from the external energy source to the implantable charger.

[0408] According to some embodiments, charging of the implantable energy source can be controlled based on the functional status of the implantable energy source. This can be achieved, for example, by controlling the power supplied or emitted by the external energy source, or by controlling the power received by the charger as outlined above. Additionally, in some instances, charging is controlled by controlling the power supplied from the charger to the implantable energy source, by controlling the power output from the charger, or by controlling the power received or absorbed by the implantable energy source. It will thus be appreciated that charging of the implantable energy source can be controlled by varying or controlling the power supplied by the external energy source at any point along the way to the implantable energy source. As exemplified above, the power supplied to the implantable energy source can thus be controlled by the external energy source, the charger, or the implantable energy source itself.

[0409] The functional status of the implanted energy source includes, for example, the charge level and the temperature. The temperature may be related to the energy source, the muscle tissue, or a part of the implant, such as the electrode array. Thus, charging may be reduced or even stopped if the charge level (or stored energy) reaches an upper limit or if the temperature exceeds a predetermined interval.

[0410] According to some embodiments, a controller (or processor or control circuit) may be provided for controlling various parts or functions of an implanted apparatus or device according to any of the above-described embodiments. The controller may be configured, for example, to include the functional status of the implanted energy source in a signal transmitted outside the body.

[0411] The controller may be operably connected to the electrode array to control electrical stimulation of the muscle tissue. The stimulation may be controlled, for example, so that the muscle tissue is stimulated with a series of electrical pulses. The electrical pulses may be characterized by their voltage and / or current. In some examples, a pulse of a first polarity may be followed by a pulse of a second, opposite polarity. The first polarity may be, for example, a positive current relative to the direction of current flow, and the second polarity may be a negative current. Alternatively, or additionally, the first polarity may be characterized by a positive voltage relative to a reference, such as ground, and the second polarity may be characterized by a negative voltage.

[0412] The controller may be configured to generate a pulsed electrical stimulation signal having a pulse frequency of 0.01-150 Hz, a pulse duration of 0.01-100 ms, and a pulse amplitude of 1-15 mA. A specific example of the electrical stimulation signal may be characterized by a pulse frequency of 0.15-0.25 Hz, a pulse duration of 20-30 ms, and a pulse amplitude of 3-10 mA.

[0413] The controller may be further configured to generate a pulsed electrical stimulation signal having varying configurations, including different durations, such as a build-up period of gradually increasing amplitude, a stimulation period during which stimulation continues, and a pause period during which stimulation is paused. Thus, by way of example, the electrical stimulation signal may include a build-up period of 0.01-2 seconds, a stimulation period of 1-60 seconds, and a rest period of 0.01-60 seconds. During the build-up and stimulation periods, the signal may include a pulse frequency of 1-50 Hz and a pulse duration of 0.1-10 ms. These durations may be varied and combined depending on the desired stimulation of muscle tissue and may further be varied based on responses monitored, for example, by a sensor connected to the controller. The sensor may be configured to measure, for example, the motor response of the muscle tissue, measured as mechanical movement or electrical response.

[0414] According to some embodiments, an implantable sensor for sensing action potentials generated by pacemaker cells in muscle tissue may be provided. The sensor is communicatively coupled to a controller, and the controller is configured to control electrical stimulation based at least in part on the sensed action potentials. This is particularly advantageous when stimulating smooth muscle tissue that may exhibit periodic contractions paced by pacemaker cells. Thus, this embodiment provides a remote control that allows for adjusting the electrical stimulation signal to amplify the sensed action potentials.

[0415] According to some embodiments, the controller may include an external controller configured to be placed outside the patient's body and an internal controller configured to be placed inside the patient's body, or an implantable controller. The wireless remote control may include an external signal transmitter configured to communicate with the internal controller. Thus, the internal controller may be configured to receive a signal transmitted by the external signal transmitter and control operation of the device or medical implant based on the signal. The signal, in some examples, is selected from the group consisting of an acoustic signal, an ultrasonic signal, an electromagnetic signal, an infrared signal, a visible light signal, an ultraviolet signal, a laser signal, a microwave signal, a radio wave signal, an X-ray signal, and a gamma ray signal.

[0416] According to an embodiment of the movement restriction device defined in any one of the above aspects, the average surface roughness is Ra as defined in accordance with ISO 21920-2:2021.

[0417] According to an embodiment of the movement restriction device defined in any one of the above aspects, the average surface roughness is Sa as defined in accordance with ISO 25178-2:2021.

[0418] According to an embodiment of the movement restriction device defined in any one of the above aspects, the average surface roughness is in the range of 0.1 to 0.5 μm.

[0419] According to an embodiment of the movement restriction device defined in any one of the above aspects, the average surface roughness is in the range of 0.1 to 0.3 μm.

[0420] According to an embodiment of the movement restriction device defined in any one of the above aspects, the implantable movement restriction device comprises a polymeric material.

[0421] According to an embodiment of the movement restriction device defined in any one of the above aspects, the implantable movement restriction device comprises at least one of a silicone-based material and a polyurethane-based material.

[0422] According to an embodiment of the movement restriction device defined in any one of the above aspects, the second solid material comprises at least one of a polypropylene based material and a polyethylene based material.

[0423] According to an embodiment of the movement restriction device defined in any one of the above aspects, the movement restriction device has an indentation hardness of at least 50 on the Shore A scale measured on the outer surface.

[0424] According to an embodiment of the movement restriction device defined in any one of the above aspects, the indentation hardness is measured by the durometer method as defined in part 4 of ISO 48-4:2018.

[0425] According to an embodiment of the movement restriction device defined in any one of the above aspects, the outer surface has an indentation hardness of 70 or less on the Shore A scale measured on the outer surface.

[0426] According to an embodiment of the movement restriction device defined in any one of the above aspects, the indentation hardness on the Shore A scale measured on the outer surface is in the range of 55-65.

[0427] According to one embodiment, an implantable movement restriction device comprises a core component and at least one outer component configured to be assembled into an implantable movement restriction device.

[0428] According to one embodiment, the core comprises a fluid.

[0429] According to one embodiment, the core portion has a resistance of 1000 kg / m 3 Includes liquids with the following densities:

[0430] According to one embodiment, the liquid is: Oily liquids, and Alcohol-based liquids.

[0431] According to one embodiment, the core comprises a gas.

[0432] According to one embodiment, the core comprises a plurality of gas volumes surrounded by a surrounding material.

[0433] According to one embodiment, the core comprises a solid polymer material surrounding a surrounding material, the surrounding material being harder than the solid polymer material.

[0434] In one embodiment, the core comprises a solid polymeric material surrounding a surrounding material, the surrounding material being harder than the solid polymeric material.

[0435] According to one embodiment, the multiple gas volumes surrounded by the surrounding material occupy at least 10% by volume of the second volume, more preferably at least 20% by volume of the second volume, and even more preferably at least 30% by volume of at least one outer portion.

[0436] According to one embodiment, the surrounding material comprises glass.

[0437] According to one embodiment, the implantable movement restriction device includes a contrast agent.

[0438] According to one embodiment, the implantable movement restriction device includes the contrast agent BaSO4.

[0439] According to one embodiment, the implantable movement restriction device includes a contrast agent in an amount of 1-15% of the weight of the implantable movement restriction device.

[0440] According to one embodiment, the implantable movement restriction device includes a contrast agent in an amount of 1-6% of the weight of the implantable movement restriction device.

[0441] According to one embodiment, the implantable movement restriction device includes a contrast agent in an amount of 8-15% of the weight of the implantable movement restriction device.

[0442] According to some embodiments, the core comprises a contrast agent in an amount of 8-15% by weight of the core.

[0443] In some embodiments, the at least one outer portion comprises a contrast agent in an amount of 1-6% of the weight of the implantable movement restriction device.

[0444] The various apparatus and methods according to the above aspects may be combined with any of the features, examples, and advantages described herein.

[0445] According to an embodiment of the movement restriction device defined in any one of the above aspects, the indentation hardness is an indentation hardness measured by the durometer method defined in part 4 of ISO 48-4:2018.

[0446] According to an embodiment of the movement restriction device defined in any one of the above aspects, the outer surface has an indentation hardness of 70 or less on the Shore A scale measured on the outer surface.

[0447] According to an embodiment of the movement restriction device defined in any one of the above aspects, the indentation hardness on the Shore A scale measured on the outer surface is in the range of 55-65.

[0448] According to one embodiment, the core comprises a fluid.

[0449] According to one embodiment, the core portion has a resistance of 1000 kg / m 3 This includes liquids with densities less than 1000 kJ / cm.

[0450] According to one embodiment, the liquid comprises at least one selected from the list: oily liquid, alcoholic liquid.

[0451] According to one embodiment, the core comprises a gas.

[0452] According to one embodiment, the core includes a plurality of gas volumes surrounded by a surrounding material.

[0453] According to one embodiment, the core comprises a solid polymer material surrounding a surrounding material, the surrounding material being harder than the solid polymer material.

[0454] According to one embodiment, the multiple gas volumes surrounded by the surrounding material occupy at least 10% by volume of the second volume, more preferably at least 20% by volume of the second volume, and even more preferably at least 30% by volume of at least one outer portion.

[0455] According to one embodiment, the surrounding material comprises glass.

[0456] An implantable medical device for treating reflux disease is also provided. The implantable medical device includes a movement restriction device configured to be anchored to the stomach wall to prevent movement of the lower esophageal sphincter relative to the thoracic diaphragm. The movement restriction device includes a first portion, a second portion, and a first distance element. The first and second portions are configured to be connected to each other to form at least a portion of a functional movement restriction device. The first and second portions are detachable from each other to allow the first and second portions to pass independently through the gastrointestinal tract, and the first distance element is configured to define a space between the first and second portions. The space is configured to allow fibrous tissue ingrowth between the first and second portions. The space is at least partially enclosed by a first surface of the first portion and a second surface of the second portion, such that the first and second surfaces are opposite each other when the first and second portions are coupled. The first straight line segment is bounded by a first point on the first surface and a second point on the second surface, the first straight line segment being greater than 1 mm. The second straight line segment is bounded by a third point on the first surface and a fourth point on the second surface. The second straight line segment is greater than 1 mm, and the first line is parallel to the second line. The first and second lines intersect with a third line that also intersects the center of gravity of the functional movement restriction device, and the distance between the first line and the second line is greater than 2 mm to allow for fibrous tissue growth to assist in fixation of the functional movement restriction device to the stomach wall.

[0457] According to one embodiment, the first distance element is integrated into at least one of the first part and the second part, and the first distance element may protrude from a surface of at least one of the first part and the second part.

[0458] According to one embodiment, the implantable medical device further comprises a first discrete distance portion having a first distance element.

[0459] According to one embodiment, at least one of the first portion and the second portion may further include a recess configured to receive a portion of the first distance element.

[0460] The first distance element, in any embodiment herein, may include at least first and second portions configured to be spaced apart from one another.

[0461] According to one embodiment, the implantable medical device may further comprise at least a third component, and the first, second and third components may be configured to be connected to one another to form at least a portion of a functional movement restriction device.

[0462] The implantable medical device according to any one of the embodiments herein may further comprise a second distance element, where the first distance element may be configured to form a space between the first portion and the second portion, and the second distance element may be configured to form a space between the first portion and the third portion. The first and second distance elements may be part of separate distance portions.

[0463] According to one embodiment, at least one of the first, second and third portions may have a recess configured to receive a portion of the distance element.

[0464] According to one embodiment, the space formed by the distance element is 100 mm 3 It may have a volume greater than 1000 .mu.m.

[0465] According to one embodiment, the space forms a recess in the implantable medical device, the recess having a depth greater than 2 mm and a width greater than 1 mm.

[0466] According to one embodiment, the distance element is configured to prevent at least one of rotation between the first and second parts, linear movement in a first direction between the first and second parts, and linear movement in the first and second directions between the first and second parts.

[0467] According to one embodiment, the first separate distance part is configured to be positioned at the center of the functional movement restriction device, and the center of gravity of the first separate distance part may substantially coincide with the center of gravity of the functional movement restriction device.

[0468] According to one embodiment, the first separate distance component comprises at least one rim including at least first and second surfaces. The first surface of the rim may be configured to engage a surface of the first component, and the second surface of the flange may be configured to engage a surface of the second component. The first and second surfaces of the at least one rim may be parallel. The first separate distance component may include at least two rims. The first rim may include at least first and second surfaces, and the first surface of the first rim may be configured to engage a surface of the first component, and the second surface of the first rim may be configured to engage a surface of the second component. The second rim may include at least first and second surfaces, and the first surface of the second rim may be configured to engage a surface of the first component, and the second surface of the second rim may be configured to engage a surface of the third component.

[0469] According to one embodiment, the first surface of the first rim and the first surface of the second rim are angled relative to each other at an angle in the range of 20° to 70°.

[0470] According to one embodiment, the first surface of the first rim and the first surface of the second rim are angled relative to each other at an angle in the range of 40° to 50°.

[0471] According to one embodiment, the first surface of the first rim and the first surface of the second rim are perpendicular.

[0472] According to one embodiment, the first distance element may be configured to engage in at least one recess of the first and second parts in the direction of the length axis of the distance element, and the part of the first distance element configured to enter the recess of the second part may include at least one surface that is angled with respect to the length axis of the distance element.

[0473] According to one embodiment, the angled surface of the first distance element may be configured to face a surface of at least one recess of the first and second portions that is angled at an angle different from the angle of the first distance element, and a point on the angled surface of the first distance element is configured to abut a point on the angled surface of the recess.

[0474] According to one embodiment, the angled surface of the first distance element abuts the angled surface of the recess over a length that is less than half the length of the angled surface of the first distance element.

[0475] According to one embodiment, the angled surface of the first distance element abuts the angled surface of the recess over a length that is less than one-third of the length of the angled surface of the first distance element.

[0476] According to one embodiment, the angled surface of the first distance element abuts the angled surface of the recess over a length that is less than half the depth of the recess measured in a direction that coincides with the direction of the length axis of the first distance element when the first distance element is partially inserted into the recess.

[0477] According to one embodiment, the portion of the first distance element configured to enter the recess of the second part comprises a tapered portion.

[0478] According to one embodiment, the tapered portion is tapered at an angle in the range of 20° to 100°.

[0479] According to one embodiment, at least one recess in the first and second portions is tapered; When the tapered portion of the first distance element is inserted into the recess, the two opposite faces of the tapered portion of the first distance element face the two opposite faces of the tapered recess. The tapered recess may be tapered at an angle in the range of 30° to 135°.

[0480] According to one embodiment, the tapered portion of the first distance element tapers at a first angle and the tapered recess of at least one of the first and second portions tapers at a second angle, the second angle being greater than the first angle. The second angle may be 3° or more greater than the first angle, 5° or more greater than the first angle, or 10° or more greater than the first angle.

[0481] According to one embodiment, the tapered portion of the first distance element and the tapered recess of at least one of the first and second portions are conical or frustum-shaped.

[0482] According to one embodiment, the tapered portion of the first distance element has the shape of a pyramid with a polygonal base.

[0483] According to one embodiment, the portion of the first distance element configured to enter the recess of the first or second part comprises at least one surface with curvature.

[0484] According to one embodiment, the surface of the first distance element having the curvature is configured to face the surface of the recess in at least one of the first and second parts, and a point on the surface of the first distance element having the curvature is configured to be tangent to a point on the surface of the recess.

[0485] According to one embodiment, the surface of the first distance element having the curvature abuts the surface of the recess over a length that is less than half the length of the angled surface of the first distance element when the first distance element is positioned within the recess in at least one of the first and second portions.

[0486] According to one embodiment, the curved surface of the first distance element contacts the surface of the recess over a length that is less than one-third of the length of the angled surface of the first distance element when a portion of the first distance element is inserted into the recess.

[0487] According to one embodiment, the curved surface of the first distance element contacts the surface of the recess over a length that is less than one-third of the length of the angled surface of the first distance element when a portion of the first distance element is inserted into the recess.

[0488] According to one embodiment, the surface of the first distance element having the curvature contacts the surface of the recess over a length that is less than half the depth of the recess measured in a direction that coincides with the direction of the length axis of the first distance element when the portion of the first distance element is inserted into the recess.

[0489] According to one embodiment, the portion of the first distance element configured to enter the recess of the second part includes at least one surface having first and second curvatures extending in a vertical direction. The portion of the first distance element configured to enter the recess of the second part may include at least one spherical surface.

[0490] According to one embodiment, at least one recess of the first and second part is tapered such that when the part of the first distance element configured to enter the recess of the first or second part is inserted into the recess, two opposite curved surfaces of the part of the first distance element configured to enter the recess of the first or second part face two opposite surfaces of the tapered recess.

[0491] According to one embodiment, at least one recess in the first and second portions includes at least one surface having a curvature. At least one recess in the first and second portions may have at least one surface having a first curvature and a second curvature extending in a vertical direction.

[0492] According to one embodiment, at least one recess in the first and second parts comprises at least one spherical surface.

[0493] According to one embodiment, the portion of the first distance element adapted to enter the recess of the first or second part comprises at least one surface having a curvature with a first radius, and at least one recess of the first and second part comprises at least one surface having a curvature with a second radius, which according to one embodiment is longer than the first radius.

[0494] According to one embodiment, the portion of the first distance element configured to enter the recess of the first or second part comprises at least one surface having first and second curvatures extending in the vertical direction.

[0495] According to one embodiment, the recess in at least one of the first and second portions comprises at least one surface having first and second curvatures extending in the vertical direction, and the sum of the first and second radii of curvature of the recess in at least one of the first and second portions is longer than the sum of the first and second radii of curvature of a portion of the first distance element configured to enter the recess.

[0496] According to one embodiment, the functional movement restriction device or the boundary of the functional movement restriction device may be elongated. The functional movement restriction device may be elongated such that its longest length is greater than 1.5 times its widest width.

[0497] According to one embodiment, the functional movement restriction device has a bend, the functional movement restriction device having a central axis that bends following extension of the functional movement restriction device.

[0498] According to one embodiment, the first portion of the functional movement restriction device is configured such that a first portion of the curved central axis is parallel to the patient's caudal-cranial axis and a second portion of the curved central axis is positioned at an angle of greater than 5° relative to the patient's caudal-cranial axis.

[0499] According to one embodiment, the second portion of the curved central shaft is configured to be positioned within the stomach at an angle toward the esophagus.

[0500] According to one embodiment, at least one of the first and second portions has a shape corresponding to an elliptical wedge or a truncated elliptical wedge.

[0501] According to one embodiment, at least one of the first and second portions has a shape corresponding to a spherical wedge or a truncated spherical wedge.

[0502] At least one of the first and second portions may have a shape corresponding to a portion of an elliptical wedge or a portion of a truncated elliptical wedge.

[0503] According to one embodiment, at least one of the first and second portions has a shape corresponding to a semi-elliptical wedge or a truncated semi-elliptical wedge.

[0504] At least one of the first and second portions may have a shape corresponding to a portion of a spherical wedge or a portion of a truncated spherical wedge.

[0505] According to one embodiment, at least one of the first and second portions has a shape corresponding to a hemispherical wedge or a truncated hemispherical wedge.

[0506] According to one embodiment, at least one of the first and second portions has a shape corresponding to an ellipsoidal segment or a portion of an ellipsoidal segment.

[0507] According to one embodiment, at least one of the first and second portions has a shape corresponding to a spherical segment or a portion of a spherical segment.

[0508] The functional movement restriction device, or the boundary of the functional movement restriction device, may have a shape corresponding to an ellipsoid or a truncated ellipsoid in any embodiment.

[0509] According to one embodiment, the functional movement restriction device or the boundary of the functional movement restriction device has a shape corresponding to a sphere or a truncated sphere.

[0510] According to one embodiment, the periphery of at least one of the first and second parts has a shape corresponding to a cylinder.

[0511] According to one embodiment, the combined periphery of the first and second portions has a shape corresponding to a cylinder.

[0512] According to one embodiment, the periphery of the first part has a shape corresponding to a first cylinder having a first radius, and the periphery of the second part has a shape corresponding to a second cylinder having a second radius, the first radius and the second radius being different.

[0513] According to one embodiment, the functional movement restriction device, or the boundary of the functional movement restriction device, comprises a stadium-shaped cross-section, or a truncated stadium-shaped cross-section.

[0514] According to one embodiment, the functional movement restriction device comprises a curved stadium shaped cross section or a truncated curved stadium shaped cross section.

[0515] According to one embodiment, the periphery of the first part has a shape corresponding to a cylindrical or ellipsoidal segment, the periphery of the second part has a shape corresponding to a cylindrical or ellipsoidal segment, the first part comprises at least one protrusion protruding from the first base surface, the second part comprises at least one recess in the first base surface, the at least one protrusion adapted to be at least partially disposed within the at least one recess. The at least one protrusion may be adapted to engage with the at least one recess, and the first part may further comprise at least one recess in the second base surface.

[0516] The position of the at least one protrusion may coincide with the position of the at least one recess, and the recess may overlap the protrusion when the first component is viewed in a direction perpendicular to the first base surface. The at least one recess may be recessed into the at least one protrusion.

[0517] According to one embodiment, at least one protrusion may have the shape of a pyramid with a polygonal base.

[0518] According to one embodiment, the first component may further include at least one protrusion on the second base surface, and the second component may further include at least one protrusion on the second base surface. The second component may further include at least one recess on the second base surface.

[0519] According to one embodiment, the implantable medical device further comprises a third part, wherein the first part further comprises a recess in the second base surface, the second part further comprises a protrusion protruding from the second base surface, and the third part comprises a protrusion protruding from the first base surface and a recess in the second base surface, wherein the protrusion of the first part is configured to be at least partially inserted into the recess of the second part, and the protrusion of the second part is configured to be at least partially inserted into the recess of the third part, and the first, second and third parts are configured to be assembled to form at least a portion of a functional implantable medical device, and the recess and protrusion stabilize the parts relative to each other when assembled.

[0520] According to one embodiment, the area of ​​the first base surface of the first part is smaller than the area of ​​the first base surface of the second part.

[0521] According to one embodiment, at least one protrusion protruding from the first base surface of the first part comprises a distance element.

[0522] According to one embodiment, the medical device is further configured to treat obesity by configuring the movement restriction device to protrude into the stomach, thereby reducing the volume of the gastric cavity. For purposes of treating obesity, the functional movement restriction device is configured to protrude into the stomach, thereby reducing the volume of the gastric cavity. 3 ~1000cm 3 Volume within the range of 100cm 3 ~500cm 3 For purposes of treating obesity, the functional implantable medical device may have a length in the range of 2.5 cm to 15 cm, or a length in the range of 5 cm to 15 cm, or a length in the range of 7 cm to 15 cm, or a length in the range of 8 cm to 15 cm, or a length in the range of 8 cm to 12 cm.

[0523] The movement restriction device, in any of the embodiments herein, may include a surface friction-reducing coating covering at least a portion of a surface of the movement restriction device, which may be configured to reduce friction between the movement restriction device and tissue of the stomach wall when the movement restriction device is at least partially invaginated.

[0524] The implantable medical device may further comprise a sensor configured to sense at least one of force and pressure to monitor the pressure or force exerted by the implantable movement restriction device on the patient's stomach wall.

[0525] According to one embodiment, the movement restriction device comprises a first portion having a first volume surrounded by implantable movement restriction device material, and a second portion having a second volume different from the first portion and surrounded by implantable movement restriction device material. The first and second volumes may be the same size, and the first volume may have a higher density than the second volume, the second volume having a density of 1000 kg / m or less. 3 It may have the following densities:

[0526] According to one embodiment, an implantable medical device can be configured to be anchored to a patient's stomach wall to function as a movement restriction device for preventing movement of the lower esophageal sphincter relative to the thoracic diaphragm. The movement restriction device includes a first portion, a second portion, and a distance element. The first and second portions can be configured to be connected to each other to form at least a portion of a functional movement restriction device. When at least one of the first and second portions is positioned within the stomach, the first and second portions can be separated from each other and the first and second portions can pass through the gastrointestinal tract individually, and the distance element is configured to form a space between the first and second portions. The space is configured to allow fibrotic tissue ingrowth between the first and second portions, forming a recess of the functional movement restriction device. The recess can be 1 mm or more wide and 2 mm or more deep to allow fibrotic tissue ingrowth to assist in anchoring the functional movement restriction device to the stomach wall.

[0527] According to one embodiment, the first distance element is integrated into at least one of the first part and the second part, and the first distance element may protrude from a surface of at least one of the first part and the second part.

[0528] According to one embodiment, the implantable medical device further comprises a first discrete distance portion having a first distance element.

[0529] According to one embodiment, at least one of the first portion and the second portion may further include a recess configured to receive a portion of the first distance element.

[0530] The first distance element, in any embodiment herein, may have at least first and second portions configured to be spaced apart from one another.

[0531] According to one embodiment, the implantable medical device further comprises at least a third component, wherein the first, second and third components may be configured to be connected to one another to form at least a portion of a functional movement restriction device.

[0532] The implantable medical device according to any one of the embodiments herein may further comprise a second distance element, where the first distance element may be configured to form a space between the first portion and the second portion, and the second distance element may be configured to form a space between the first portion and the third portion. The first and second distance elements may be part of separate distance portions.

[0533] According to one embodiment, at least one of the first, second and third portions may include a recess configured to receive a portion of the distance element.

[0534] According to one embodiment, the space formed by the distance element is 100 mm 3 It may have a volume exceeding 1000 vol.

[0535] According to one embodiment, the space forms a recess in the implantable medical device, the recess having a depth greater than 2 mm and a width greater than 1 mm.

[0536] According to one embodiment, the distance element is configured to prevent at least one of rotation between the first and second parts, linear movement in a first direction between the first and second parts, and linear movement in the first and second directions between the first and second parts.

[0537] According to one embodiment, the first separate distance part is configured to be positioned at the center of the functional movement restriction device, and the center of gravity of the first separate distance part can substantially coincide with the center of gravity of the functional movement restriction device.

[0538] According to one embodiment, the first separate distance component comprises at least one rim including at least first and second surfaces. The first surface of the rim may be configured to engage a surface of the first component, and the second surface of the flange may be configured to engage a surface of the second component. The first and second surfaces of the at least one rim may be parallel. The first separate distance component may have at least two rims. The first rim may have at least first and second surfaces, and the first surface of the first rim may be configured to engage a surface of the first component, and the second surface of the first rim may be configured to engage a surface of the second component. The second rim may have at least first and second surfaces, and the first surface of the second rim may be configured to engage a surface of the first component, and the second surface of the second rim may be configured to engage a surface of the third component.

[0539] According to one embodiment, the first surface of the first rim and the first surface of the second rim are angled relative to each other at an angle in the range of 20° to 70°.

[0540] According to one embodiment, the first surface of the first rim and the first surface of the second rim are angled relative to each other at an angle in the range of 40° to 50°.

[0541] According to one embodiment, the first surface of the first rim and the first surface of the second rim are perpendicular.

[0542] According to one embodiment, the first distance element may be configured to engage in at least one recess of the first and second parts in the direction of the length axis of the distance element, and the part of the first distance element configured to enter the recess of the second part may have at least one surface that is angled with respect to the length axis of the distance element.

[0543] According to one embodiment, the angled surface of the first distance element may be configured to face a surface of at least one recess of the first and second portions that is angled at an angle different from the angle of the first distance element, and a point on the angled surface of the first distance element is configured to abut a point on the angled surface of the recess.

[0544] According to one embodiment, the angled surface of the first distance element abuts the angled surface of the recess over a length that is less than half the length of the angled surface of the first distance element.

[0545] According to one embodiment, the angled surface of the first distance element abuts the angled surface of the recess over a length that is less than one-third of the length of the angled surface of the first distance element.

[0546] According to one embodiment, the angled surface of the first distance element abuts the angled surface of the recess over a length that is less than half the depth of the recess measured in a direction that coincides with the direction of the length axis of the first distance element when the first distance element is partially inserted into the recess.

[0547] According to one embodiment, the portion of the first distance element configured to enter the recess of the second part comprises a tapered portion.

[0548] According to one embodiment, the tapered portion is tapered at an angle in the range of 20° to 100°.

[0549] According to one embodiment, at least one recess of the first and second parts is tapered such that when the tapered portion of the first distance element is inserted into the recess, two opposite sides of the tapered portion of the first distance element face two opposite sides of the tapered recess. The tapered recess may taper at an angle in the range of 30° to 135°.

[0550] According to one embodiment, the tapered portion of the first distance element tapers at a first angle and the tapered recess of at least one of the first and second portions tapers at a second angle, the second angle being greater than the first angle. The second angle may be 3° or more greater than the first angle, 5° or more greater than the first angle, or 10° or more greater than the first angle.

[0551] According to one embodiment, the tapered portion of the first distance element and the tapered recess of at least one of the first and second portions are conical or frustum-shaped.

[0552] According to one embodiment, the tapered portion of the first distance element has the shape of a pyramid with a polygonal base.

[0553] According to one embodiment, the portion of the first distance element configured to enter the recess of the first or second part comprises at least one surface with curvature.

[0554] According to one embodiment, the surface of the first distance element having the curvature is configured to face the surface of the recess in at least one of the first and second parts, and a point on the surface of the first distance element having the curvature is configured to be tangent to a point on the surface of the recess.

[0555] According to one embodiment, the surface of the first distance element having the curvature abuts the surface of the recess over a length that is less than half the length of the angled surface of the first distance element when the first distance element is positioned within the recess in at least one of the first and second portions.

[0556] According to one embodiment, the curved surface of the first distance element contacts the surface of the recess over a length that is less than one-third of the length of the angled surface of the first distance element when a portion of the first distance element is inserted into the recess.

[0557] According to one embodiment, the surface of the first distance element having the curvature contacts the surface of the recess over a length that is less than half the depth of the recess measured in a direction that coincides with the direction of the length axis of the first distance element when the portion of the first distance element is inserted into the recess.

[0558] According to one embodiment, the portion of the first distance element configured to enter the recess of the second part includes at least one surface having first and second curvatures extending in the vertical direction. The portion of the first distance element configured to enter the recess of the second part may have at least one spherical surface.

[0559] According to one embodiment, the recess of at least one of the first and second parts is tapered such that when the portion of the first distance element configured to fit into the recess of the first or second part is inserted into the recess, two opposite curved surfaces of the portion of the first distance element configured to fit into the recess of the first or second part face two opposite surfaces of the tapered recess.

[0560] According to one embodiment, at least one recess in the first and second portions includes at least one surface having a curvature. At least one recess in the first and second portions may have at least one surface having a first curvature and a second curvature extending in a vertical direction.

[0561] According to one embodiment, at least one recess in the first and second parts comprises at least one spherical surface.

[0562] According to one embodiment, the portion of the first distance element adapted to enter the recess of the first or second part comprises at least one surface having a curvature with a first radius, and at least one recess of the first and second part comprises at least one surface having a curvature with a second radius, which according to one embodiment is longer than the first radius.

[0563] According to one embodiment, the portion of the first distance element configured to enter the recess of the first or second part comprises at least one surface having first and second curvatures extending in the vertical direction.

[0564] According to one embodiment, the recess in at least one of the first and second portions comprises at least one surface having first and second curvatures extending in the vertical direction, and the sum of the first and second radii of curvature of the recess in at least one of the first and second portions is longer than the sum of the first and second radii of curvature of a portion of the first distance element configured to enter the recess.

[0565] According to one embodiment, the functional movement restriction device or the boundary of the functional movement restriction device may be elongated. The functional movement restriction device may be elongated such that its longest length is greater than 1.5 times its widest width.

[0566] According to one embodiment, the functional movement restriction device comprises a bend, the functional movement restriction device having a central axis that is bent following extension of the functional movement restriction device.

[0567] According to one embodiment, the first portion of the functional movement restriction device is configured such that a first portion of the curved central axis is parallel to the patient's coccygeal-cranial axis and a second portion of the curved central axis is positioned at an angle of greater than 5° relative to the patient's coccygeal-cranial axis.

[0568] According to one embodiment, the second portion of the curved central shaft is configured to be positioned within the stomach at an angle toward the esophagus.

[0569] According to one embodiment, at least one of the first and second portions has a shape corresponding to an elliptical wedge or a truncated elliptical wedge.

[0570] According to one embodiment, at least one of the first and second portions has a shape corresponding to a spherical wedge or a truncated spherical wedge.

[0571] At least one of the first and second portions may have a shape corresponding to a portion of an elliptical wedge or a portion of a truncated elliptical wedge.

[0572] According to one embodiment, at least one of the first and second portions has a shape corresponding to a semi-elliptical wedge or a truncated semi-elliptical wedge.

[0573] At least one of the first and second portions may have a shape corresponding to a portion of a spherical wedge or a portion of a truncated spherical wedge.

[0574] According to one embodiment, at least one of the first and second portions has a shape corresponding to a hemispherical wedge or a truncated hemispherical wedge.

[0575] According to one embodiment, at least one of the first and second portions has a shape corresponding to an ellipsoidal segment or a portion of an ellipsoidal segment.

[0576] According to one embodiment, at least one of the first and second portions has a shape corresponding to a spherical segment or a portion of a spherical segment.

[0577] The functional movement restriction device, or the boundary of the functional movement restriction device, may have a shape corresponding to an ellipsoid or a truncated ellipsoid in any embodiment.

[0578] According to one embodiment, the functional movement restriction device or the boundary of the functional movement restriction device has a shape corresponding to a sphere or a truncated sphere.

[0579] According to one embodiment, the periphery of at least one of the first and second parts has a shape corresponding to a cylinder.

[0580] According to one embodiment, the combined circumference of the first and second portions has a corresponding circumference of a cylinder.

[0581] According to one embodiment, the periphery of the first part has a shape corresponding to a first cylinder having a first radius, and the periphery of the second part has a shape corresponding to a second cylinder having a second radius, the first radius and the second radius being different.

[0582] According to one embodiment, the functional movement restriction device, or the boundary of the functional movement restriction device, comprises a stadium-shaped cross-section, or a truncated stadium-shaped cross-section.

[0583] According to one embodiment, the functional movement restriction device comprises a curved stadium-shaped cross section or a truncated curved stadium-shaped cross section.

[0584] According to one embodiment, the periphery of the first part has a shape corresponding to a cylindrical or ellipsoidal segment, the periphery of the second part has a shape corresponding to a cylindrical or ellipsoidal segment, the first part comprises at least one protrusion protruding from the first base surface, the second part comprises at least one recess in the first base surface, the at least one protrusion adapted to be at least partially disposed within the at least one recess. The at least one protrusion may be adapted to engage with the at least one recess, and the first part may further comprise at least one recess in the second base surface.

[0585] The position of the at least one protrusion may coincide with the position of the at least one recess, and the recess may overlap the protrusion when the first component is viewed in a direction perpendicular to the first base surface. The at least one recess may be recessed within the at least one protrusion.

[0586] According to one embodiment, at least one protrusion may have the shape of a pyramid with a polygonal base.

[0587] According to one embodiment, the first component may further include at least one protrusion on the second base surface, and the second component may further include at least one protrusion on the second base surface. The second component may further include at least one recess on the second base surface.

[0588] According to one embodiment, the implantable medical device further comprises a third part, wherein the first part further comprises a recess in the second base surface, wherein the second part further comprises a protrusion protruding from the second base surface, wherein the third part comprises a protrusion protruding from the first base surface and a recess in the second base surface, wherein the protrusion of the first part is configured to be at least partially inserted into the recess of the second part, and wherein the protrusion of the second part is configured to be at least partially inserted into the recess of the third part, wherein the first, second and third parts are configured to be assembled to form at least a portion of a functional implantable medical device, wherein the recess and protrusion stabilize the parts relative to each other when assembled.

[0589] According to one embodiment, the area of ​​the first base surface of the first part is smaller than the area of ​​the first base surface of the second part.

[0590] According to one embodiment, at least one protrusion protruding from the first base surface of the first part comprises a distance element.

[0591] According to one embodiment, the medical device is further configured to treat obesity by configuring the movement restriction device to protrude into the stomach, thereby reducing the volume of the gastric cavity. For purposes of treating obesity, the functional movement restriction device is configured to protrude into the stomach, thereby reducing the volume of the gastric cavity. 3 ~1000cm 3 Volume within the range of 100cm 3 ~500cm 3For purposes of treating obesity, the functional implantable medical device may have a length in the range of 2.5 cm to 15 cm, or a length in the range of 5 cm to 15 cm, or a length in the range of 7 cm to 15 cm, or a length in the range of 8 cm to 15 cm, or a length in the range of 8 cm to 12 cm.

[0592] The movement restriction device, in any of the embodiments herein, may include a surface friction-reducing coating covering at least a portion of a surface of the movement restriction device, which may be configured to reduce friction between the movement restriction device and tissue of the stomach wall when the movement restriction device is at least partially invaginated.

[0593] The implantable medical device may further comprise a sensor configured to sense at least one of force and pressure to monitor the pressure or force exerted by the implantable movement restriction device on the patient's stomach wall.

[0594] According to one embodiment, the movement restriction device comprises a first portion having a first volume surrounded by implantable movement restriction device material, and a second portion different from the first portion having a second volume surrounded by implantable movement restriction device material. The first and second volumes may be equally large, and the first volume may have a higher density than the second volume, the second volume being greater than 1000 kg / m. 3 It may have a density of less than 1000 .mu.m.

[0595] Further provided is an implantable medical device for treating reflux disease, comprising a movement restriction device configured to be anchored to the stomach wall to prevent movement of the lower esophageal sphincter relative to the thoracic diaphragm. The movement restriction device comprises a first part and a second part. The first part and the second part are configured to be connected to each other to form at least a portion of a functional movement restriction device. The first and second parts are detachable from each other so that the first and second parts can pass through the gastrointestinal tract independently. The periphery of the first part has a shape corresponding to a cylindrical or ellipsoidal segment, and the periphery of the second part has a shape corresponding to a cylindrical or ellipsoidal segment. The first part has at least one protrusion protruding from a first base surface, and the second part has at least one recess in the first base surface, the at least one protrusion adapted to be at least partially disposed within the at least one recess to stabilize the first and second parts relative to each other.

[0596] According to one embodiment, at least one protrusion of the first part of the movement restriction device is adapted to engage in at least one recess of the second part of the movement restriction device.

[0597] According to one embodiment, the first part further comprises at least one recess in the second base surface.

[0598] According to one embodiment, the position of the at least one protrusion coincides with the position of the at least one recess, such that the recess overlaps the protrusion when the first component is viewed in a direction perpendicular to the first base surface. The at least one recess may be recessed within the at least one protrusion.

[0599] According to one embodiment, at least one protrusion is adapted to engage with at least one recess in the direction of the length axis of the protrusion, and an adapted portion of the protrusion is adapted to engage with at least one recess in the direction of the length axis of the protrusion.

[0600] At least one surface at least partially disposed within the at least one recess is angled relative to a longitudinal axis of the protrusion.

[0601] According to one embodiment, the angled surface of the protrusion is configured to face a surface of the recess of the second portion that is angled at an angle different from the angle of the protrusion, and a point on the angled surface of the protrusion is configured to abut a point on the angled surface of the recess.

[0602] According to one embodiment, the angled surface of the protrusion abuts the angled surface of the recess over a length that is less than half the length of the angled surface of the protrusion.

[0603] The angled surface of the protrusion may abut the angled surface of the recess over a length that is less than one-third the length of the angled surface of the protrusion.

[0604] According to one embodiment, the angled surface of the protrusion abuts the angled surface of the recess over a length that is less than half the depth of the recess measured in a direction that coincides with the direction of the length axis of the protrusion when a portion of the protrusion is inserted into the recess.

[0605] According to one embodiment, the portion of the protrusion adapted to enter the recess in the second portion comprises a tapered portion, which may taper at an angle in the range of 20° to 150°.

[0606] According to one embodiment, at least one recess of the first and second parts is tapered such that when the tapered portion of the first distance element is inserted into the recess, two opposite sides of the tapered portion of the protrusion face two opposite sides of the tapered recess. The tapered recess may be tapered at an angle in the range of 30° to 155°.

[0607] According to one embodiment, the tapered portion of the protrusion tapers at a first angle and the tapered recess of at least one of the first and second portions tapers at a second angle, the second angle being greater than the first angle. The second angle may be 3° or more greater than the first angle, 5° or more greater than the first angle, or 10° or more greater than the first angle.

[0608] According to one embodiment, at least one protrusion has the shape of a pyramid with a polygonal base.

[0609] According to one embodiment, the first component further comprises at least one protrusion on the second base surface, and the second component further comprises at least one protrusion on the second base surface. The second component may further comprise at least one recess in the second base surface.

[0610] According to one embodiment, the implantable medical device further comprises a third component, wherein the first component further comprises a recess in the second base surface, the second component further comprises a protrusion protruding from the second base surface, and the third component comprises the protrusion protruding from the first base surface and the recess in the second base surface, the protrusion of the first component configured to be at least partially inserted into the recess of the second component, and the protrusion of the second component configured to be at least partially inserted into the recess of the third component, the first, second, and third components configured to be assembled to form at least a portion of a functional implantable medical device, the recess and protrusion stabilizing the components relative to one another when assembled.

[0611] According to one embodiment, the area of ​​the first base surface of the first part is smaller than the area of ​​the first base surface of the second part.

[0612] The functional movement restriction device, or the boundary of the functional movement restriction device, may have a shape corresponding to an ellipsoid or a truncated ellipsoid in any embodiment.

[0613] According to one embodiment, the functional movement restriction device or the boundary of the functional movement restriction device has a shape corresponding to a sphere or a truncated sphere.

[0614] According to one embodiment, the periphery of at least one of the first and second parts has a shape corresponding to a cylinder.

[0615] According to one embodiment, the combined periphery of the first and second parts has a shape corresponding to a cylinder.

[0616] According to one embodiment, the periphery of the first part has a shape corresponding to a first cylinder having a first radius, and the periphery of the second part has a shape corresponding to a second cylinder having a second radius, the first radius and the second radius being different.

[0617] According to one embodiment, the functional movement restriction device, or the boundary of the functional movement restriction device, comprises a stadium-shaped cross-section, or a truncated stadium-shaped cross-section.

[0618] According to one embodiment, the functional movement restriction device comprises a curved stadium-shaped cross section or a truncated curved stadium-shaped cross section.

[0619] According to one embodiment, the functional movement restriction device or the boundary of the functional movement restriction device may be elongated. The functional movement restriction device may be elongated such that its longest length is greater than 1.5 times its widest width.

[0620] According to one embodiment, the functional movement restriction device defines a bend, the functional movement restriction device defining a bent central axis following extension of the functional movement restriction device.

[0621] According to one embodiment, the first portion of the functional movement restriction device is configured such that a first portion of the curved central axis is parallel to the patient's coccygeal-cranial axis and a second portion of the curved central axis is positioned at an angle of greater than 5° relative to the patient's coccygeal-cranial axis.

[0622] According to one embodiment, the second portion of the curved central shaft is configured to be positioned within the stomach at an angle toward the esophagus.

[0623] According to one embodiment, the protrusion comprises a first distance element configured to form a space between the first and second parts. The space is configured to allow fibrous tissue ingrowth between the first and second parts, the space being at least partially enclosed by a first surface of the first part and a second surface of the second part, and the first and second surfaces are disposed opposite each other when the first and second parts are connected. A first straight line segment is bounded by a first point on the first surface and a second point on the second surface. The first straight line segment is 1 mm or greater. The second straight line segment is bounded by a third point on the first surface and a fourth point on the second surface. The second straight line segment is greater than 1 mm, and the first straight line is parallel to the second straight line. The first and second lines intersect with a third line that also intersects the center of gravity of the functional movement restriction device, and the distance between the first and second lines is greater than 2 mm to allow for the growth of fibrous tissue to assist in the fixation of the functional movement restriction device to the stomach wall.

[0624] According to one embodiment, the protrusion includes a first distance element configured to form a space located between the first and second portions, the space configured to allow fibrous tissue ingrowth between the first and second portions, the space forming a recess in the functional implantable medical device, the recess being greater than 1 mm wide and greater than 2 mm deep to allow fibrous tissue ingrowth to aid in anchoring the functional implantable medical device to the stomach wall.

[0625] According to one embodiment, the medical device is further configured to treat obesity by configuring the movement restriction device to protrude into the stomach, thereby reducing the volume of the gastric cavity. For purposes of treating obesity, the functional movement restriction device is configured to protrude into the stomach, thereby reducing the volume of the gastric cavity. 3 ~1000cm 3 Volume within the range of 100cm3 ~500cm 3 For purposes of treating obesity, the functional implantable medical device may have a length in the range of 2.5 cm to 15 cm, or a length in the range of 5 cm to 15 cm, or a length in the range of 7 cm to 15 cm, or a length in the range of 8 cm to 15 cm, or a length in the range of 8 cm to 12 cm.

[0626] The movement restriction device, in any of the embodiments herein, may include a surface friction-reducing coating covering at least a portion of a surface of the movement restriction device, which may be configured to reduce friction between the movement restriction device and tissue of the stomach wall upon at least partial invagination of the movement restriction device.

[0627] The implantable medical device may further comprise a sensor configured to sense at least one of force and pressure to monitor the pressure or force exerted by the implantable movement restriction device on the patient's stomach wall.

[0628] According to one embodiment, the movement restriction device comprises a first portion having a first volume surrounded by implantable movement restriction device material, and a second portion different from the first portion having a second volume surrounded by implantable movement restriction device material. The first and second volumes may be equally large, and the first volume may have a higher density than the second volume, the second volume being greater than 1000 kg / m. 3 It may have a density of less than 1000 .mu.m.

[0629] An apparatus for treating reflux disease in a human patient is also provided. The apparatus includes an implantable movement restriction device having a shape and size that allows it to be positioned to rest against a portion of the fundus wall of the patient's stomach. The movement restriction device is adapted for implantation at a position between the patient's thoracic diaphragm and a portion of the fundus wall, and restricts movement of the patient's lower esophageal sphincter of the stomach toward the thoracic diaphragm to prevent the lower esophageal sphincter from sliding through an opening in the thoracic diaphragm into the patient's thoracic cavity. The apparatus further includes an electrode arrangement configured to engage and electrically stimulate the lower esophageal sphincter to induce contraction of the lower esophageal sphincter. The apparatus further includes an electrical impedance sensor configured to measure changes in electrical impedance within the tissue of the lower esophageal sphincter or within esophageal tissue to detect swallowing in the patient, and a stimulation controller configured to control electrical stimulation of the lower esophageal sphincter in response to a signal from the electrical impedance sensor.

[0630] According to one embodiment, the device further comprises a reference electrode connected to the stimulation controller, the stimulation controller configured to generate an output from the sensor based on an electrical interaction between the electrical impedance sensor and the reference electrode.

[0631] According to one embodiment, the stimulation control device is configured to generate a time-varying signal having frequency content that varies in the range of 1-10 kHz.

[0632] According to one embodiment, the stimulation control device is configured to generate a time-varying signal having frequency content that varies in the range of 2-8 kHz.

[0633] According to one embodiment, the stimulation control device is configured to generate a time-varying signal having frequency content that varies in the range of 4-6 kHz.

[0634] According to one embodiment, the electrode arrangement includes at least two electrode elements configured to be placed on opposite sides of the lower esophageal sphincter.

[0635] According to one embodiment, the device further comprises a holder configured to support at least two electrode elements on opposite sides of the cardiac sphincter.

[0636] According to one embodiment, the device further comprises an implantable energy source configured to power the electrodes.

[0637] According to one embodiment, the implantable energy source is located within the movement restriction device.

[0638] An implantable medical device for treating obesity is also provided. The implantable medical device is configured to be anchored to the stomach wall and protrude into the stomach, thereby reducing the volume of the gastric cavity. The implantable medical device includes a first part, a second part, and a first distance element. The first and second parts are configured to be connected to each other to form at least a portion of a functional implantable medical device. The first and second parts are detachable from each other to allow the first and second parts to pass independently through the gastrointestinal tract. The first distance element is configured to form a space between the first and second parts. The space is configured to allow fibrous tissue ingrowth between the first and second parts. The space is at least partially enclosed by a first surface of the first part and a second surface of the second part. The first and second surfaces are positioned opposite each other when the first and second parts are coupled. A first straight line segment is bounded by a first point on the first surface and a second point on the second surface, the first straight line segment being greater than 1 mm. A second straight line segment is bounded by a third point on the first surface and a fourth point on the second surface, the second straight line segment being greater than 1 mm. The first line is parallel to the second line, and the first and second lines intersect with a third line that also intersects the center of gravity of the functional medical device. The distance between the first and second lines is greater than 2 mm to allow for fibrous tissue ingrowth to assist in fixation of the functional implantable medical device to the stomach wall.

[0639] A functional implantable medical device is 100 cm 3 ~1000cm 3 range, preferably 100 cm 3 ~500cm 3 The volume may be in the range of

[0640] The functional implantable medical device may have a length in the range of 2.5 cm to 15 cm, more preferably in the range of 5 cm to 15 cm, even more preferably in the range of 7 cm to 15 cm, even more preferably in the range of 8 cm to 15 cm, even more preferably in the range of 8 cm to 12 cm.

[0641] According to one embodiment, the first distance element is integrated into at least one of the first part and the second part, and the first distance element may protrude from a surface of at least one of the first part and the second part.

[0642] According to one embodiment, the implantable medical device further comprises a first discrete distance portion comprising a first distance element.

[0643] According to one embodiment, at least one of the first and second portions may further include a recess configured to receive a portion of the first distance element.

[0644] The first distance element, in any embodiment herein, may have at least first and second portions configured to be spaced apart from one another.

[0645] According to one embodiment, the implantable medical device further comprises at least a third component, wherein the first, second and third components may be configured to be connected to one another to form at least a portion of a functional movement restriction device.

[0646] The implantable medical device according to any one of the embodiments herein may further comprise a second distance element, where the first distance element may be configured to form a space between the first portion and the second portion, and the second distance element may be configured to form a space between the first portion and the third portion. The first and second distance elements may be part of separate distance portions.

[0647] According to one embodiment, at least one of the first, second and third portions may include a recess configured to receive a portion of the distance element.

[0648] According to one embodiment, the space formed by the distance element is 100 mm 3 It may have a volume greater than 1000 .mu.m.

[0649] According to one embodiment, the space forms a recess in the implantable medical device, the recess having a depth greater than 2 mm and a width greater than 1 mm.

[0650] According to one embodiment, the distance element is configured to prevent at least one of rotation between the first and second parts, linear movement in a first direction between the first and second parts, and linear movement in the first and second directions between the first and second parts.

[0651] According to one embodiment, the first separate distance part is configured to be positioned at the center of the functional movement restriction device, and the center of gravity of the first separate distance part may substantially coincide with the center of gravity of the functional movement restriction device.

[0652] According to one embodiment, the first separate distance component comprises at least one rim including at least first and second surfaces. The first surface of the rim may be configured to engage a surface of the first component, and the second surface of the flange may be configured to engage a surface of the second component. The first and second surfaces of the at least one rim may be parallel. The first separate distance component may have at least two rims. The first rim may have at least first and second surfaces, and the first surface of the first rim may be configured to engage a surface of the first component, and the second surface of the first rim may be configured to engage a surface of the second component. The second rim may have at least first and second surfaces, and the first surface of the second rim may be configured to engage a surface of the first component, and the second surface of the second rim may be configured to engage a surface of the third component.

[0653] According to one embodiment, the first surface of the first rim and the first surface of the second rim are angled relative to each other at an angle in the range of 20° to 70°.

[0654] According to one embodiment, the first surface of the first rim and the first surface of the second rim are angled relative to each other at an angle in the range of 40° to 50°.

[0655] According to one embodiment, the first surface of the first rim and the first surface of the second rim are perpendicular.

[0656] According to one embodiment, the first distance element may be configured to engage in at least one recess of the first and second parts in the direction of the length axis of the distance element, and the part of the first distance element configured to enter the recess of the second part may have at least one surface that is angled with respect to the length axis of the distance element.

[0657] According to one embodiment, the angled surface of the first distance element may be configured to face a surface of at least one recess of the first and second portions that is angled at an angle different from the angle of the first distance element, and a point on the angled surface of the first distance element is configured to abut a point on the angled surface of the recess.

[0658] According to one embodiment, the angled surface of the first distance element abuts the angled surface of the recess over a length that is less than half the length of the angled surface of the first distance element.

[0659] According to one embodiment, the angled surface of the first distance element abuts the angled surface of the recess over a length that is less than one-third of the length of the angled surface of the first distance element.

[0660] According to one embodiment, the angled surface of the first distance element abuts the angled surface of the recess over a length that is less than half the depth of the recess measured in a direction that coincides with the direction of the length axis of the first distance element when the first distance element is partially inserted into the recess.

[0661] According to one embodiment, the portion of the first distance element configured to enter the recess of the second part comprises a tapered portion.

[0662] According to one embodiment, the tapered portion is tapered at an angle in the range of 20° to 100°.

[0663] According to one embodiment, at least one recess of the first and second parts is tapered such that when the tapered portion of the first distance element is inserted into the recess, two opposite faces of the tapered portion of the first distance element face two opposite faces of the tapered recess. The tapered recess may taper at an angle in the range of 30° to 135°.

[0664] According to one embodiment, the tapered portion of the first distance element tapers at a first angle and the tapered recess of at least one of the first and second portions tapers at a second angle, the second angle being greater than the first angle. The second angle may be greater than 3°, greater than 5°, or greater than 10° than the first angle.

[0665] According to one embodiment, the tapered portion of the first distance element and the tapered recess of at least one of the first and second portions are conical or frustum-shaped.

[0666] According to one embodiment, the tapered portion of the first distance element has the shape of a pyramid with a polygonal base.

[0667] According to one embodiment, the portion of the first distance element configured to enter the recess of the first or second part comprises at least one surface with curvature.

[0668] According to one embodiment, the surface of the first distance element having the curvature is configured to face the surface of the recess in at least one of the first and second parts, and a point on the surface of the first distance element having the curvature is configured to be tangent to a point on the surface of the recess.

[0669] According to one embodiment, the surface of the first distance element having the curvature abuts the surface of the recess over a length that is less than half the length of the angled surface of the first distance element when the first distance element is positioned within the recess in at least one of the first and second portions.

[0670] According to one embodiment, the curved surface of the first distance element contacts the surface of the recess over a length that is less than one-third of the length of the angled surface of the first distance element when a portion of the first distance element is inserted into the recess.

[0671] According to one embodiment, the curved surface of the first distance element contacts the surface of the recess over a length that is less than one-third of the length of the angled surface of the first distance element when a portion of the first distance element is inserted into the recess.

[0672] According to one embodiment, the surface of the first distance element having the curvature contacts the surface of the recess over a length that is less than half the depth of the recess measured in a direction that coincides with the direction of the length axis of the first distance element when the portion of the first distance element is inserted into the recess.

[0673] According to one embodiment, the portion of the first distance element configured to enter the recess of the second part includes at least one surface having first and second curvatures extending in a vertical direction. The portion of the first distance element configured to enter the recess of the second part may include at least one spherical surface.

[0674] According to one embodiment, the recess of at least one of the first and second parts is tapered such that when the portion of the first distance element configured to fit into the recess of the first or second part is inserted into the recess, two opposite curved surfaces of the portion of the first distance element configured to fit into the recess of the first or second part face two opposite curved surfaces of the tapered recess.

[0675] According to one embodiment, at least one recess in the first and second portions includes at least one surface having a curvature. At least one recess in the first and second portions may have at least one surface having a first curvature and a second curvature extending in a vertical direction.

[0676] According to one embodiment, at least one recess in the first and second parts comprises at least one spherical surface.

[0677] According to one embodiment, the portion of the first distance element adapted to enter the recess of the first or second part comprises at least one surface having a curvature with a first radius, and at least one recess of the first and second part comprises at least one surface having a curvature with a second radius, which according to one embodiment is longer than the first radius.

[0678] According to one embodiment, the portion of the first distance element configured to enter the recess of the first or second part comprises at least one surface having first and second curvatures extending in the vertical direction.

[0679] According to one embodiment, the recess in at least one of the first and second portions comprises at least one surface having first and second curvatures extending in the vertical direction, and the sum of the first and second radii of curvature of the recess in at least one of the first and second portions is longer than the sum of the first and second radii of curvature of a portion of the first distance element configured to enter the recess.

[0680] According to one embodiment, the functional implantable medical device or the boundary of the functional medical device may be elongated. The functional implantable medical device may be elongated such that its longest length is greater than 1.5 times its widest width.

[0681] According to one embodiment, the functional implantable medical device comprises a bend, the functional implantable medical device comprising a central axis that is bent following extension of the functional implantable medical device.

[0682] According to one embodiment, the first portion of the functional implantable medical device is configured such that the first portion of the curved central axis is parallel to the patient's coccygeal-cranial axis and the second portion of the curved central axis is positioned at an angle of greater than 5° relative to the patient's coccygeal-cranial axis.

[0683] According to one embodiment, the second portion of the curved central shaft is configured to be positioned within the stomach at an angle toward the esophagus.

[0684] According to one embodiment, at least one of the first and second portions has a shape corresponding to an elliptical wedge or a truncated elliptical wedge.

[0685] According to one embodiment, at least one of the first and second portions has a shape corresponding to a spherical wedge or a truncated spherical wedge.

[0686] At least one of the first and second portions may have a shape corresponding to a portion of an elliptical wedge or a portion of a truncated elliptical wedge.

[0687] According to one embodiment, at least one of the first and second portions has a shape corresponding to a semi-elliptical wedge or a truncated semi-elliptical wedge.

[0688] At least one of the first and second portions may have a shape corresponding to a portion of a spherical wedge or a portion of a truncated spherical wedge.

[0689] According to one embodiment, at least one of the first and second portions has a shape corresponding to a hemispherical wedge or a truncated hemispherical wedge.

[0690] According to one embodiment, at least one of the first and second portions has a shape corresponding to an ellipsoidal segment or a portion of an ellipsoidal segment.

[0691] According to one embodiment, at least one of the first and second portions has a shape corresponding to a spherical segment or a portion of a spherical segment.

[0692] The boundary of the functional movement restriction device, or functional implantable medical device, in any embodiment may have a shape corresponding to an ellipsoid or a truncated ellipsoid.

[0693] According to one embodiment, the functional implantable medical device, or the boundary of the functional implantable medical device, has a shape corresponding to a sphere or a truncated sphere.

[0694] According to one embodiment, the periphery of at least one of the first and second parts has a shape corresponding to a cylinder.

[0695] According to one embodiment, the combined periphery of the first and second parts has a shape corresponding to a cylinder.

[0696] According to one embodiment, the periphery of the first part has a shape corresponding to a first cylinder having a first radius, and the periphery of the second part has a shape corresponding to a second cylinder having a second radius, the first radius and the second radius being different.

[0697] According to one embodiment, the functional implantable medical device, or the boundary of the functional implantable medical device, comprises a stadium-shaped cross-section, or a truncated stadium-shaped cross-section.

[0698] According to one embodiment, the functional implantable medical device comprises a curved stadium-shaped cross-section or a truncated curved stadium-shaped cross-section.

[0699] According to one embodiment, the periphery of the first part has a shape corresponding to a cylindrical or ellipsoidal segment, the periphery of the second part has a shape corresponding to a cylindrical or ellipsoidal segment, the first part comprises at least one protrusion protruding from the first base surface, the second part comprises at least one recess in the first base surface, the at least one protrusion adapted to be at least partially disposed within the at least one recess. The at least one protrusion may be adapted to engage with the at least one recess, and the first part may further comprise at least one recess in the second base surface.

[0700] The position of the at least one protrusion may coincide with the position of the at least one recess, and the recess may overlap the protrusion when the first component is viewed in a direction perpendicular to the first base surface. The at least one recess may be recessed into the at least one protrusion.

[0701] According to one embodiment, at least one protrusion may have the shape of a pyramid with a polygonal base.

[0702] According to one embodiment, the first component may further include at least one protrusion on the second base surface, and the second component may further include at least one protrusion on the second base surface. The second component may further include at least one recess on the second base surface.

[0703] According to one embodiment, the implantable medical device further comprises a third part, wherein the first part further comprises a recess in the second base surface, wherein the second part further comprises a protrusion protruding from the second base surface, wherein the third part comprises the protrusion protruding from the first base surface and the recess in the second base surface, wherein the protrusion of the first part is configured to be at least partially inserted into the recess of the second part, and wherein the protrusion of the second part is configured to be at least partially inserted into the recess of the third part, wherein the first, second and third parts are configured to be assembled to form at least a portion of a functional implantable medical device, wherein the recess and protrusion stabilize the parts relative to each other when assembled.

[0704] According to one embodiment, the area of ​​the first base surface of the first part is smaller than the area of ​​the first base surface of the second part.

[0705] According to one embodiment, at least one protrusion protruding from the first base surface of the first part comprises a distance element.

[0706] The implantable medical device, in any of the embodiments herein, may include a surface friction-reducing coating covering at least a portion of a surface of the implantable medical device, which may be configured to reduce friction between the implantable medical device and tissue of the stomach wall into which the implantable medical device is at least partially invaginated.

[0707] The implantable medical device may further comprise a sensor configured to sense at least one of force and pressure to monitor the pressure or force exerted by the implantable medical device on the patient's stomach wall.

[0708] According to one embodiment, an implantable medical device comprises a first portion having a first volume surrounded by implantable medical device material and a second portion different from the first portion having a second volume surrounded by implantable medical device material. The first and second volumes may be equally large, and the first volume may have a higher density than the second volume, the second volume being greater than 1000 kg / m. 3 It may have a density of less than 1000 .mu.m.

[0709] An implantable medical device for treating reflux disease is also provided. The implantable medical device comprises a movement restriction device configured to be anchored to the stomach wall to prevent movement of the lower esophageal sphincter relative to the thoracic diaphragm. The movement restriction device includes a central portion and at least two outer portions. The central portion and the at least two outer portions are configured to be connected to each other to form at least a portion of a functional movement restriction device. The central portion and the at least two outer portions are detachable from each other to allow the central portion and the at least two outer portions to pass through the gastrointestinal tract independently. The outer surface of the functional movement restriction device includes at least four flat surfaces spaced apart from each other and separated by at least four curved surfaces, the combined area of ​​the at least four flat surfaces being in the range of 10% to 20% of the total surface area of ​​the functional movement restriction device. According to one embodiment, the functional movement restriction device includes at least five flat surfaces. According to one embodiment, the outer surface of the functional movement restriction device includes at least six flat surfaces. According to one embodiment, the outer surface of the functional movement restriction device includes at least seven flat surfaces. According to one embodiment, the outer surface of the functional movement restriction device includes at least eight flat surfaces.

[0710] The flat surface in any of the embodiments may be oval, circular, or polygonal.

[0711] An implantable medical device for treating reflux disease is also provided. The implantable medical device includes a movement restriction device configured to be anchored to the stomach wall to prevent movement of the lower esophageal sphincter relative to the thoracic diaphragm. The movement restriction device includes a central portion and at least two outer portions. The central portion and the at least two outer portions are configured to be connected to each other to form at least a portion of a functional movement restriction device. The central portion and the at least two outer portions are detachable from each other to allow the central portion and the at least two outer portions to pass independently through the gastrointestinal tract. According to one embodiment, the functional movement restriction device and at least one of the boundaries of the functional movement restriction device are separated by a distance of 2 cm. 3 ~9cm 3 and according to another embodiment, the functional movement restriction device or the boundary of the functional movement restriction device has a volume in the range of 2 cm 3 ~8.5cm 3 and according to another embodiment, the functional movement restriction device or the boundary of the functional movement restriction device has a volume in the range of 3 cm 3 ~8cm 3 , or 3 cm 3 ~7.5cm 3 , or 3 cm 3 ~7cm 3 , or 4 cm 3 ~7cm 3 The volume ranges from 0.01 to 0.01.

[0712] An implantable medical device for treating reflux disease is also provided. The implantable medical device includes a movement restriction device configured to be anchored to the stomach wall to prevent movement of the lower esophageal sphincter relative to the thoracic diaphragm, the movement restriction device including at least two components configured to be connected to each other to form at least a portion of a functional movement restriction device, the at least two components being detachable from each other to allow the at least two components to pass individually through the gastrointestinal tract. The functional movement restriction device has a height ranging from 0.5 cm to 3 cm, or a height ranging from 1 cm to 3 cm, or a height ranging from 1.5 cm to 3 cm, or a height ranging from 1.5 cm to 2.5 cm, or a height ranging from 1 cm to 2.5 cm.

[0713] The implantable medical device may further include a central portion, and the at least two portions may be configured to be connected to the central portion to form at least a portion of a functional movement restriction device. The central portion and the at least two portions may be detachable from one another to allow the central portion and the at least two portions to pass independently through the gastrointestinal tract.

[0714] An implantable medical device for treating reflux disease is also provided. The implantable medical device includes a movement restriction device configured to be anchored to the stomach wall to prevent movement of the lower esophageal sphincter relative to the thoracic diaphragm. The movement restriction device includes a central portion and at least two outer portions. The central portion and the at least two outer portions are configured to be connected to each other to form at least a portion of a functional movement restriction device. The central portion and the at least two outer portions are detachable from each other to allow the central portion and the at least two outer portions to pass through the gastrointestinal tract independently. At least one of the two outer portions includes a wedge-shaped portion, and the central portion includes a wedge-shaped portion. The wedge-shaped portion of the at least one outer portion is configured to be positioned within the wedge-shaped portion of the central portion, and the wedge-shaped portion of the at least one outer portion is wedge-shaped with a first angle. The wedge-shaped portion of the central portion is wedge-shaped with a second angle, the first angle being greater than 3° or greater than 7°. According to one embodiment, the first angle is more than 10° greater than the second angle, according to another embodiment, the first angle is more than 12° greater than the second angle, and according to another embodiment, the first angle is more than 15° greater than the second angle. The wedge-shaped portion of the at least one outer portion may be comprised of a wedge-shaped recess configured to engage with the wedge-shaped protrusion of the central portion, or the at least one outer portion may include a wedge-shaped protrusion configured to engage with the wedge-shaped recess of the central portion. The wedge-shaped portion of the central portion may have a wedge-shaped recess or a wedge-shaped protrusion.

[0715] An implantable medical device for treating reflux disease is also provided. The implantable medical device includes a movement restriction device configured to be anchored to the stomach wall to prevent movement of the lower esophageal sphincter relative to the thoracic diaphragm. The movement restriction device includes a central portion and at least two outer portions. The central portion and the at least two outer portions are configured to be connected to each other to form at least a portion of a functional movement restriction device. The central portion and the at least two outer portions are detachable from each other to allow the central portion and the at least two outer portions to pass through the gastrointestinal tract independently. At least one of the two outer portions includes a wedge-shaped portion, and the central portion includes a wedge-shaped portion. The wedge-shaped portion of the central portion is configured to be positioned within the wedge-shaped portion of the central portion, and the wedge-shaped portion of the at least one outer portion is wedge-shaped with a first angle, and the wedge-shaped portion of the central portion is wedge-shaped with a second angle, the second angle being at least 7° greater than the first angle. According to one embodiment, the second angle is 10° or more greater than the first angle, according to another embodiment, the second angle is 12° or more greater than the first angle, and according to another embodiment, the second angle is 15° or more greater than the first angle.

[0716] The wedge-shaped portion of at least one of the outer portions may have a wedge-shaped recess or a wedge-shaped protrusion. The wedge-shaped portion of the central portion may have a wedge-shaped recess or a wedge-shaped protrusion.

[0717] An implantable medical device for treating reflux disease is also provided. The implantable medical device includes a movement restriction device configured to be anchored to the stomach wall to prevent movement of the lower esophageal sphincter relative to the thoracic diaphragm. The movement restriction device includes a central portion and at least two outer portions. The central portion and the at least two outer portions are configured to be connected to each other to form at least a portion of a functional movement restriction device. The central portion and the at least two outer portions are detachable from each other to allow the central portion and the at least two outer portions to pass independently through the gastrointestinal tract. At least one of the two outer portions includes a contact surface configured to contact the contact surface of the central portion, and at least one of the contact surface of the at least one outer portion and the contact surface of the central portion is curved.

[0718] According to one embodiment, the contact surface of at least one of the outer portions and the contact surface of the central portion are convex.

[0719] According to one embodiment, at least one of the contact surfaces of the at least one outer portion and the contact surface of the central portion is concave.

[0720] According to one embodiment, at least one of the contact surfaces of the at least one outer portion and the contact surface of the central portion defines an ellipse point.

[0721] According to one embodiment, the contact surface of the at least one outer part is in contact with the contact surface of the central part over less than half of the area of ​​the contact surface of the at least one outer part.

[0722] According to one embodiment, the contact surface of the at least one outer part is in contact with the contact surface of the central part over less than one third of the area of ​​the contact surface of the at least one outer part.

[0723] An implantable medical device for treating reflux disease is also provided. The implantable medical device comprises a movement restriction device configured to be anchored to the stomach wall to prevent movement of the lower esophageal sphincter relative to the thoracic diaphragm. The movement restriction device includes a central portion and at least two outer portions. The central portion and the at least two outer portions are configured to be connected to each other to form at least a portion of a functional movement restriction device. The central portion and the at least two outer portions are detachable from each other to allow the central portion and the at least two outer portions to pass through the gastrointestinal tract independently. The central portion includes at least three spaced apart, vertically extending rims, each having at least one contact surface configured to contact at least one surface of the at least two outer portions. At least a portion of the at least three vertically extending rims are wedge-shaped with an angle ranging from 20° to 60°.

[0724] According to one embodiment, a portion of the at least three vertically extending rims is wedge-shaped with an angle of more than 25°.

[0725] According to one embodiment, a portion of the at least three vertically extending rims is wedge-shaped with an angle of more than 30°.

[0726] According to one embodiment, a portion of the at least three vertically extending rims is wedge-shaped with an angle of more than 35°.

[0727] At least one vertically extending wedge-shaped portion of the rim may taper away from the center of gravity of the central portion.

[0728] According to one embodiment, the vertically extending rim has an elongated wedge-shaped portion, the elongated wedge-shaped portion of the vertically extending rim tapering in the direction of extension of the vertically extending rim.

[0729] The implantable medical device may further include at least one horizontally extending rim extending substantially perpendicularly from at least one of the vertically extending rims, and the horizontally extending rim may include a wedge-shaped portion. The wedge-shaped portion of the horizontally extending rim may taper away from the center of gravity of the central portion.

[0730] According to one embodiment, the horizontally extending wedge-shaped portion of the rim has a wedge shape with an angle in the range of 20° to 60°.

[0731] An implantable medical device for treating reflux disease is also provided. The implantable medical device includes a movement restriction device configured to be anchored to the stomach wall to prevent movement of the lower esophageal sphincter relative to the thoracic diaphragm. The movement restriction device includes a central portion and at least two outer portions. The central portion and the at least two outer portions are configured to be connected to each other to form at least a portion of a functional movement restriction device. The central portion and the at least two outer portions are detachable from each other to allow the central portion and the at least two outer portions to pass through the gastrointestinal tract independently. The central portion includes at least one horizontally extending rim extending in a direction perpendicular to a vertical plane, the central portion having at least one contact surface configured to contact at least one surface of the at least two outer portions. A portion of the horizontally extending rim is wedge-shaped with an angle ranging from 20° to 60°.

[0732] According to one embodiment, a portion of the horizontally extending rim is wedge-shaped with an angle of more than 25°, or more than 30°, or more than 35°.

[0733] According to one embodiment, the horizontally extending wedge-shaped portion of the rim tapers away from the center of gravity of the central portion.

[0734] According to one embodiment, the implantable medical device further comprises at least two vertically extending limbs extending substantially perpendicularly from the horizontally extending limb.

[0735] According to one embodiment, the vertically extending rim includes a wedge-shaped portion.

[0736] According to one embodiment, the vertically extending wedge-shaped portion of the rim tapers away from the center of gravity of the central portion.

[0737] According to one embodiment, the vertically extending wedge-shaped portion of the rim is wedge-shaped with an angle in the range of 20° to 60°.

[0738] An implantable medical device for treating reflux disease is also provided. The implantable medical device includes a movement restriction device configured to be anchored to the stomach wall to prevent movement of the lower esophageal sphincter relative to the thoracic diaphragm. The movement restriction device includes a central portion and at least two outer portions. The central portion and the at least two outer portions are configured to be connected to each other to form at least a portion of a functional movement restriction device. The central portion and the at least two outer portions are detachable from each other to allow the central portion and the at least two outer portions to pass independently through the gastrointestinal tract. The mass of the central portion exceeds the mass of at least one of the outer portions.

[0739] According to one embodiment, the mass of the central portion exceeds the mass of at least one of the outer portions by at least 10%.

[0740] According to one embodiment, the mass of the central portion exceeds the mass of at least one of the outer portions by at least 20%.

[0741] According to one embodiment, the mass of the central portion exceeds the mass of at least one of the outer portions by at least 30%.

[0742] According to one embodiment, the volume of the central portion exceeds the volume of at least one of the outer portions by at least 10%.

[0743] According to one embodiment, the volume of the central portion exceeds the volume of at least one of the outer portions by at least 20%.

[0744] According to one embodiment, the volume of the central portion exceeds the volume of at least one of the outer portions by at least 30%.

[0745] An implantable medical device for treating reflux disease is also provided. The implantable medical device includes a movement restriction device configured to be anchored to the stomach wall to prevent movement of the lower esophageal sphincter relative to the thoracic diaphragm. The movement restriction device includes a central portion and at least two outer portions. The central portion and the at least two outer portions are configured to be connected to each other to form at least a portion of a functional movement restriction device. The central portion and the at least two outer portions are detachable from each other to allow the central portion and the at least two outer portions to pass through the gastrointestinal tract independently. The longest cross-sectional distance of at least one of the outer portions is at least 20% greater than the longest cross-sectional distance of the central portion.

[0746] According to one embodiment, the longest cross-sectional distance of at least one of the outer portions exceeds the longest cross-sectional distance of the central portion by at least 30%.

[0747] According to one embodiment, the longest cross-sectional distance of at least one of the outer portions exceeds the longest cross-sectional distance of the central portion by at least 40%.

[0748] According to one embodiment, the longest cross-sectional distance of at least one of the outer portions exceeds the longest cross-sectional distance of the central portion by at least 50%.

[0749] There is also provided an implantable medical device for treating reflux disease, the implantable medical device comprising a movement restriction device configured to be anchored to the stomach wall to prevent movement of the lower esophageal sphincter relative to the thoracic diaphragm.

[0750] According to one embodiment, at least one of the movement restriction device and the boundary of the movement restriction device is less than 5 cm 2 ~25cm 2 in the range of 10cm 2 ~25cm 2 in the range of 10cm 2 ~20cm 2 in the range of 15cm 2 ~20cm 2 It has a surface area in the range of

[0751] According to one embodiment, the movement restriction device is elongated and has a height that is its longest cross-sectional distance and a width that is its longest cross-sectional distance perpendicular to the height, the height being in the range of 1.2 to 2 times the width. According to one embodiment, the height is in the range of 1.3 to 2 times the width. According to one embodiment, the height is in the range of 1.2 to 1.8 times the width. According to one embodiment, the height is in the range of 1.3 to 1.6 times the width.

[0752] According to one embodiment, the movement restriction device has a height in the range of 0.5 cm to 3 cm, or a height in the range of 1 cm to 3 cm, or a height in the range of 1.5 cm to 3 cm, or a height in the range of 1.5 cm to 2.5 cm, or a height in the range of 1 cm to 2.5 cm.

[0753] According to one embodiment, at least one of the movement restriction device and the boundary of the movement restriction device is less than 2 cm 3 ~10cm 3 and according to another embodiment, the movement restriction device or the boundary of the movement restriction device has a volume in the range of 2 cm 3 ~9cm 3 and according to another embodiment, the movement restriction device or the boundary of the movement restriction device has a volume in the range of 2 cm 3 ~8.5cm 3 and according to another embodiment, the movement restriction device or the boundary of the movement restriction device has a volume in the range of 3 cm 3 ~8cm 3 or 3 cm 3 ~7.5cm 3or 3 cm 3 ~7cm 3 or 4 cm 3 ~7cm 3 The volume ranges from 0.01 to 0.01.

[0754] There is also provided an implantable medical device for treating reflux disease, the implantable medical device comprising a movement restriction device configured to be anchored to a stomach wall to prevent movement of a lower esophageal sphincter relative to the thoracic diaphragm, the movement restriction device comprising at least two components configured to be connected to one another to form at least a portion of a functional movement restriction device, the at least two components being detachable from one another to allow the at least two components to pass independently through the gastrointestinal tract, and at least one of the functional movement restriction device and boundaries of the functional movement restriction device being within 5 cm. 2 ~25cm 2 It has a surface area in the range of

[0755] According to one embodiment, at least one of the functional movement restriction device and the boundary of the functional movement restriction device is within 10 cm. 2 ~25cm 2 It has a surface area in the range of

[0756] According to one embodiment, at least one of the functional movement restriction device and the boundary of the functional movement restriction device is within 10 cm. 2 ~22cm 2 It has a surface area in the range of

[0757] According to one embodiment, at least one of the functional movement restriction device and the boundary of the functional movement restriction device is within 10 cm. 2 ~20cm 2 It has a surface area in the range of

[0758] According to one embodiment, at least one of the functional movement restriction device and the boundary of the functional movement restriction device is less than 15 cm 2 ~20cm 2 It has a surface area in the range of

[0759] According to one embodiment, at least one of the functional movement restriction device and the boundary of the functional movement restriction device is less than 12 cm. 2 ~20cm 2 It has a surface area in the range of

[0760] According to one embodiment, the functional movement restriction device is elongated and has a height that is the longest cross-sectional distance and a width that is the longest cross-sectional distance perpendicular to the height, the height being 1.2 to 2 times the width. According to one embodiment, the height is in the range of 1.3 to 2 times the width. According to one embodiment, the height is in the range of 1.2 to 1.8 times the width. According to one embodiment, the height is in the range of 1.3 to 1.6 times the width.

[0761] According to one embodiment, the functional movement restriction device has a height in the range of 0.5 cm to 3 cm, or a height in the range of 1 cm to 3 cm, or a height in the range of 1.5 cm to 2.5 cm, or a height in the range of 1 cm to 2.5 cm.

[0762] According to one embodiment, the implantable medical device further comprises a central portion, and the at least two portions are configured to be connected to the central portion to form at least a portion of a functional movement restriction device, the central portion and the at least two portions being detachable from one another to allow the central portion and the at least two portions to pass independently through the gastrointestinal tract.

[0763] An implantable medical device for treating reflux disease is also provided. The implantable medical device includes a movement restriction device configured to be anchored to the stomach wall to prevent movement of the lower esophageal sphincter relative to the thoracic diaphragm. The movement restriction device is comprised of at least two components configured to be connected to one another to form at least a portion of a functional movement restriction device. The at least two components are detachable from one another to allow the at least two components to pass through the gastrointestinal tract independently. The functional movement restriction device is elongated and has a height that is the longest cross-sectional distance and a width that is the longest cross-sectional distance perpendicular to the height, the height being in the range of 1.2 to 2 times the width.

[0764] According to one embodiment, the height is in the range of 1.3 to 2 times the width. According to one embodiment, the height is in the range of 1.2 to 1.8 times the width. According to one embodiment, the height is in the range of 1.3 to 1.6 times the width.

[0765] According to one embodiment, the functional movement restriction device has a height in the range of 0.5cm to 3cm, alternatively has a height in the range of 1cm to 3cm, alternatively has a height in the range of 1.5cm to 3cm, alternatively has a height in the range of 1.5cm to 2.5cm, alternatively has a height in the range of 1cm to 2.5cm.

[0766] The implantable medical device may further include a central portion, and the at least two portions may be configured to be connected to the central portion to form at least a portion of a functional movement restriction device. The central portion and the at least two portions may be detachable from one another to allow the central portion and the at least two portions to pass independently through the gastrointestinal tract.

[0767] A surgical method for treating reflux disease is also provided, comprising the steps of at least partially dissecting the fundus posteriorly, dissecting the esophagus so that the esophagus is separated from surrounding tissue at least 3 cm cranial to the angle of His, and connecting the fundus to the esophagus by placing at least two posterior sutures or staplers on the left-sinister-posterior side of the esophagus and at least two anterior sutures or staplers on the left-sinister-anterior side of the esophagus, connecting the fundus to the esophagus. The surgical method further comprises the step of securing an implantable migration restriction device to the fundus to prevent the lower esophageal sphincter from sliding through the esophageal hiatus.

[0768] According to one embodiment, the surgical method step of at least partially dissecting the gastric fundus posteriorly includes at least partially releasing the fundus from at least one of the gastrophrenic ligament and the gastrosplenic ligament. The step of at least partially dissecting the gastric fundus posteriorly may include dissecting the fundus at least 0.5 cm posterior to a coronal plane intersecting the most cranial point of the fundus, or dissecting the gastric fundus at least 1 cm posterior to a coronal plane intersecting the most cranial point of the fundus.

[0769] According to one embodiment, the method step of at least partially incising the fundus posteriorly may include incising the fundus at least 0.5 cm posterior to the most anterior fixation point of the gastrophrenic ligament of the gastric fundus, or at least 1 cm posterior to the most anterior fixation point of the gastrophrenic ligament of the gastric fundus.

[0770] According to one embodiment, the surgical method step of at least partially dissecting the fundus posteriorly comprises dissecting the fundus at least 0.5 cm posterior to the extension of the greater curvature of the stomach in the region of the fundus, or at least 1 cm posterior to the extension of the greater curvature of the stomach in the region of the fundus.

[0771] According to one embodiment, the surgical method step of dissecting the esophagus includes dissecting the esophagus such that the esophagus is separated from surrounding tissue at least 4 cm cranial to the Angle of His, preferably at least 5 cm cranial to the Angle of His, and most preferably at least 6 cm cranial to the Angle of His.

[0772] According to one embodiment, the surgical method step of dissecting the esophagus so that it is separated from surrounding tissue includes dissecting the esophagus into the mediastinum, wherein the step of dissecting the esophagus into the mediastinum includes dissecting the esophagus into the mediastinum so that it is separated from surrounding tissue at least 1 cm cranial from the distal end of the esophageal hiatus, preferably at least 2 cm cranial from the distal end of the esophageal hiatus, and most preferably at least 3 cm cranial from the distal end of the esophageal hiatus.

[0773] According to one embodiment, the step of dissecting the esophagus into the mediastinum comprises dissecting the esophagus distally from a location 2 cm distal to the esophageal plexus of the vagus nerve, preferably 1 cm distal to the esophageal plexus of the vagus nerve, and more preferably 0.5 cm distal to the esophageal plexus of the vagus nerve.

[0774] According to one embodiment, the step of dissecting the esophagus includes freeing the esophagus from the crus muscle.

[0775] According to one embodiment, the surgical method step of placing at least two posterior sutures or staples on the left posterior side of the esophagus connecting the fundus to the esophagus includes placing at least two continuous sutures on the left posterior side of the esophagus connecting the fundus to the esophagus.

[0776] According to one embodiment, the surgical method step of placing at least two anterior sutures or staples on the left anterior side of the esophagus connecting the fundus to the esophagus includes placing at least two continuous sutures on the left anterior side of the esophagus connecting the fundus to the esophagus.

[0777] In any of the embodiments herein, at least one of the beginning and ending ends of the running suture may be performed within the serosa of the stomach wall to secure the suture to the serosa of the stomach wall.

[0778] According to one embodiment, the surgical method step of placing at least two posterior sutures or staples on the left posterior side of the esophagus connecting the fundus to the esophagus includes placing at least two lateral sutures on the left posterior side of the esophagus substantially along the cranial-caudal axis.

[0779] According to one embodiment, the surgical method step of placing at least two anterior sutures or staples on the left anterior side of the esophagus connecting the fundus to the esophagus includes placing at least two lateral sutures on the left anterior side of the esophagus substantially along the cranial-coccygeal axis.

[0780] According to one embodiment, the surgical method step of placing at least two posterior sutures or staples on the left posterior side of the esophagus connecting the fundus to the esophagus includes placing at least two posterior sutures or staples at least 0.5 cm posterior to a coronal plane intersecting the cranial-most point of the fundus.

[0781] According to one embodiment, the surgical method step of placing at least two anterior sutures or staples on the left anterior side of the esophagus connecting the fundus to the esophagus includes placing at least two anterior sutures or staples at least 0.5 cm anterior to the coronal plane intersecting the cranial-most point of the fundus.

[0782] According to one embodiment, the surgical method step of placing at least two posterior sutures or staples on the left posterior side of the esophagus connecting the fundus to the esophagus includes placing the most caudal suture or staple at least 0.5 cm from the angle of His.

[0783] According to one embodiment, the surgical method step of placing at least two anterior sutures or staples on the left anterior side of the esophagus connecting the fundus to the esophagus includes placing the most caudal suture or staple at least 0.5 cm from the angle of His.

[0784] According to one embodiment, the surgical method step of placing at least two posterior sutures or staples on the left posterior side of the esophagus connecting the fundus to the esophagus includes placing the most caudal suture or staple at least 1.5 cm from the angle of His.

[0785] According to one embodiment, the surgical method step of placing at least two anterior sutures or staples on the left anterior side of the esophagus connecting the fundus to the esophagus includes placing the most caudal suture or staple at least 1.5 cm from the angle of His.

[0786] According to one embodiment, the surgical method step of placing the most caudal of at least two posterior sutures or staples connecting the fundus to the esophagus includes placing the most caudal of the at least two posterior sutures or staples on the left posterior side of the esophagus at least 0.5 cm from the angle of His to connect the fundus to the esophagus, and placing the most caudal of the at least two anterior sutures or staples on the left anterior side of the esophagus not less than 1.5 cm from the angle of His to connect the fundus to the esophagus.

[0787] According to one embodiment, the surgical method step of placing the most caudal of at least two posterior sutures or staples connecting the fundus to the esophagus includes placing the most caudal of the at least two posterior sutures or staples on the left posterior side of the esophagus at least 1.5 cm from the angle of His to connect the fundus to the esophagus, and placing the most caudal of the at least two anterior sutures or staples on the left anterior side of the esophagus not less than 0.5 cm from the angle of His to connect the fundus to the esophagus.

[0788] According to one embodiment, the step of the surgical method of connecting the fundus to the esophagus further comprises placing at least one central suture or stapler on the cranio-coccygeal axis extending between at least two posterior sutures or staplers and at least two anterior sutures or staplers. The step of placing at least one central suture or stapler on the cranio-coccygeal axis may comprise placing at least one central suture or stapler that is detached from the at least two anterior sutures or staplers and from the at least two posterior sutures or staplers to maintain the possibility of radially expanding the esophagus to limit the dysphagia disk.

[0789] According to one embodiment, the surgical method steps of placing at least two posterior sutures or staples on the left posterior side of the esophagus connecting the fundus to the esophagus and placing at least two anterior sutures or staples on the left anterior side of the esophagus connecting the fundus to the esophagus include at least partially using barbed sutures.

[0790] In any of the surgical methods described herein, the step of securing the implantable migration restriction device to the fundus may include placing continuous purse-string roof sutures in the fundus region to constrict the stomach tissue by pulling on ends of the purse-string sutures in the region of the greater curvature of the stomach. The step of placing the roof sutures may include placing at least one of the continuous purse-string roof sutures in the fundus region at least 1 cm posterior to the greater curvature of the stomach.

[0791] According to one embodiment, the step of placing a continuous purse string roof suture may include placing the continuous purse string roof suture at least in part using a non-barbed suture.

[0792] According to one embodiment, the surgical method step of placing a continuous purse string roof suture includes starting or ending the continuous purse string roof suture at a location at least 0.5 cm from the esophagus.

[0793] According to one embodiment, the surgical method step of placing a continuous purse string roof suture may include placing the continuous purse string roof suture using a suture that terminates in a loop so that the suture can be pulled through the loop to retract the stomach tissue.

[0794] In any of the surgical methods described herein, the step of anchoring the implantable movement restriction device to the fundus may include inserting the implantable movement restriction device into the patient's abdomen. Inserting the implantable movement restriction device into the patient's abdomen may include inserting the implantable movement restriction device into the patient's abdomen using an insertion tool having an elongated abdominal portion.

[0795] According to one embodiment, the surgical method step of securing the implantable movement restriction device to the fundus may include forcing the implantable movement restriction device into the fundus in a cranial-dorsal direction with an instrument having an elongated abdominal portion. The step of forcing the implantable movement restriction device into the fundus in a dorsal-cranial direction with an instrument having an elongated abdominal portion may include forcing the implantable movement restriction device into the fundus in a dorsal-cranial direction with the instrument such that a portion of the implantable medical device terminates on the dorsal side of roof sutures for placing the movement restriction device into the fundus to facilitate subsequent invagination at the top in the fundus position.

[0796] According to one embodiment, the step of anchoring the implantable movement restriction device comprises placing continuous purse-string base sutures in a region of the caudal end of the implantable movement restriction device. The step of placing continuous purse-string floor sutures in a region of the caudal end of the implantable movement restriction device may comprise placing at least two of the continuous purse-string floor sutures along an arc. When at least two continuous purse-string floor sutures are placed along an arc, the continuous purse-string floor sutures may be placed along an arc below the elongated abdominal portion of the apparatus holding the implantable movement restriction device.

[0797] According to one embodiment, the step of placing a continuous purse string base suture in a region of the caudal end of the implantable movement restriction device may include placing the continuous purse string base suture such that the continuous purse string base suture forms a closed curve.

[0798] According to one embodiment, the step of securing the implantable movement restriction device to the fundus includes placing at least one suture or stapler from stomach wall to stomach wall over the elongated abdominal portion of the instrument that holds the implantable movement restriction device.

[0799] According to one embodiment, the step of placing a continuous purse string base suture in the region of the caudal end of the implantable movement restriction device may include placing one of the continuous purse string base sutures from stomach wall to stomach wall over the elongated abdominal portion of the apparatus holding the implantable movement restriction device.

[0800] The step of securing the implantable movement restriction device to the base may include releasing the elongated abdominal portion of the apparatus from the implantable movement restriction device.

[0801] According to one embodiment, the step of securing the implantable motion restriction device to the fundus may include placing at least one suture or staple from stomach wall to stomach wall in the area where the elongated abdominal portion of the device was removed to close the hole through which the elongated abdominal portion of the device passed.

[0802] According to one embodiment, the step of placing a continuous purse string base suture in the region of the caudal end of the implantable movement restriction device may include placing the continuous purse string base suture using at least a non-barbed suture to allow for contraction and relaxation of the stomach wall during the surgical procedure.

[0803] According to one embodiment, the step of securing the implantable movement restriction device to the fundus includes contracting a first portion of the stomach wall by pulling the purse string roof suture and contracting a second portion of the stomach wall by pulling the purse string base suture, thereby securing the implantable movement restriction device to the stomach wall between the first contracted portion and the second contracted portion.

[0804] The surgical method according to any one of the preceding embodiments may further include the step of fixing the implantable movement restriction device to the fundus by invaginating the implantable movement restriction device into the fundus wall from the outside of the fundus wall. The step of invaginating the implantable movement restriction device into the fundus wall from the outside of the fundus wall may include placing at least two sutures or staples from stomach wall to stomach wall to connect the stomach walls around the implantable movement restriction device, thereby sealing the implantable movement restriction device in a pouch formed by the fundus stomach wall. The step of invaginating the implantable movement restriction device may include completing the invagination by securing the sutures to the serosa of the stomach wall for long-term fixation.

[0805] According to one embodiment, the step of securing the implantable migration restriction device to the fundus includes measuring the length of the loop formed by the purse string roof suture by pulling the purse string roof suture to contract a first portion of the stomach wall and securing the purse string roof suture to the serosa of the stomach wall.

[0806] There is also provided a surgical method for treating reflux disease, comprising connecting a fundus to the esophagus, the connecting step comprising: placing at least two posterior sutures or staples substantially along the cranial-coccygeal axis on a left posterior side of the esophagus to connect the fundus to the esophagus at the left posterior side of the esophagus, and placing at least two anterior sutures or staples substantially along the cranial-coccygeal axis on a left posterior side of the esophagus to connect the fundus to the esophagus at the left posterior side of the esophagus. The surgical method further comprises securing an implantable migration restriction device to the fundus to prevent the lower esophageal sphincter from sliding through the esophageal hiatus.

[0807] According to one embodiment, the surgical method step of placing at least two posterior sutures or staples on the left posterior side of the esophagus connecting the fundus to the esophagus includes placing at least two continuous sutures on the left posterior side of the esophagus connecting the fundus to the esophagus.

[0808] According to one embodiment, the surgical method step of placing at least two anterior sutures or staples on the left anterior side of the esophagus connecting the fundus to the esophagus includes placing at least two continuous sutures on the left anterior side of the esophagus connecting the fundus to the esophagus.

[0809] In any of the embodiments herein, at least one of the beginning and ending ends of the running suture may be within the serosa of the stomach wall to secure the suture to the serosa of the stomach wall.

[0810] According to one embodiment, the surgical method step of placing at least two posterior sutures or staples on the left posterior side of the esophagus connecting the fundus to the esophagus includes placing at least two lateral sutures on the left posterior side of the esophagus substantially along the cranial-coccygeal axis.

[0811] According to one embodiment, the surgical method step of placing at least two anterior sutures or staples on the left anterior side of the esophagus connecting the fundus to the esophagus includes placing at least two lateral sutures on the left anterior side of the esophagus substantially along the cranial-coccygeal axis.

[0812] According to one embodiment, the surgical method step of placing at least two posterior sutures or staples on the left posterior side of the esophagus connecting the fundus to the esophagus includes placing at least two posterior sutures or staples at least 0.5 cm posterior to a coronal plane intersecting the cranial-most point of the fundus.

[0813] According to one embodiment, the surgical method step of placing at least two anterior sutures or staples on the left anterior side of the esophagus connecting the fundus to the esophagus includes placing at least two anterior sutures or staples at least 0.5 cm anterior from the coronal plane intersecting the cranial-most point of the fundus.

[0814] According to one embodiment, the surgical method step of placing at least two posterior sutures or staples on the left posterior side of the esophagus connecting the fundus to the esophagus includes placing the most caudal suture or staple at least 0.5 cm from the angle of His.

[0815] According to one embodiment, the surgical method step of placing at least two anterior sutures or staples on the left anterior side of the esophagus connecting the fundus to the esophagus includes placing the most caudal suture or staple at least 0.5 cm from the angle of His.

[0816] According to one embodiment, the surgical method step of placing at least two posterior sutures or staples on the left posterior side of the esophagus connecting the fundus to the esophagus includes placing the most caudal suture or staple at least 1.5 cm from the angle of His.

[0817] According to one embodiment, the surgical method step of placing at least two anterior sutures or staples on the left anterior side of the esophagus connecting the fundus to the esophagus includes placing the most caudal suture or staple at least 1.5 cm from the angle of His.

[0818] According to one embodiment, the surgical method step of placing the most caudal of the at least two posterior sutures or staples on the left posterior side of the esophagus at least 0.5 cm from the angle of His to connect the fundus to the esophagus, and placing the most caudal of the at least two anterior sutures or staples on the left anterior side of the esophagus at least 1.5 cm from the angle of His to connect the fundus to the esophagus.

[0819] According to one embodiment, the surgical method step of placing the most caudal of the at least two posterior sutures or staples on the left posterior side of the esophagus at least 1.5 cm from the angle of His to connect the fundus to the esophagus, and placing the most caudal of the at least two anterior sutures or staples on the left anterior side of the esophagus at least 0.5 cm from the angle of His to connect the fundus to the esophagus.

[0820] According to one embodiment, the step of the surgical method of connecting the fundus to the esophagus further includes placing at least one central suture or stapler on the cranio-coccygeal axis extending between at least two posterior sutures or staplers and at least two anterior sutures or staplers. The step of placing at least one central suture or stapler on the cranio-coccygeal axis may include placing at least one central suture or stapler separate from the at least two anterior sutures or staplers and from the at least two posterior sutures or staplers to maintain the possibility of radially expanding the esophagus to limit dysphagia discs.

[0821] According to one embodiment, the surgical method steps of placing at least two posterior sutures or staples on the left posterior side of the esophagus connecting the fundus to the esophagus and placing at least two anterior sutures or staples on the left anterior side of the esophagus connecting the fundus to the esophagus include at least partially using barbed sutures.

[0822] There is also provided a surgical method for treating reflux disease, the surgical method comprising at least partially dissecting a fundus posteriorly, the step of at least partially dissecting the fundus posteriorly comprising at least partially releasing the fundus from at least one of the gastrophrenic ligament and the gastrosplenic ligament, and securing an implantable migration restriction device to the fundus to prevent the lower esophageal sphincter from sliding through the esophageal hiatus.

[0823] The step of at least partially dissecting the fundus posteriorly may include dissecting the fundus at least 0.5 cm posterior to a coronal plane intersecting the most cranial point of the fundus, or at least partially dissecting the fundus posteriorly at least 1 cm posterior to a coronal plane intersecting the most cranial point of the fundus.

[0824] According to one embodiment, the surgical method step of at least partially incising the fundus posteriorly may comprise incising the fundus at least 0.5 cm posterior to the most anterior fixation point of the gastrophrenic ligament on the fundus, or at least 1 cm posterior to the most anterior fixation point of the gastrophrenic ligament at the fundus.

[0825] According to one embodiment, the surgical method step of at least partially dissecting the fundus posteriorly comprises dissecting the fundus at least 0.5 cm posterior to the extension of the greater curvature of the stomach in the region of the fundus, or at least 1 cm posterior to the extension of the greater curvature of the stomach in the region of the fundus.

[0826] In any of the surgical methods described herein, the step of securing the implantable migration restriction device to the fundus may include placing continuous purse string roof sutures in the region of the fundus in the region of the greater curvature of the stomach such that tension on the ends of the purse string sutures can constrict the stomach tissue. The step of placing the roof sutures may include placing at least one of the continuous purse string roof sutures in the region of the fundus at least 1 cm posterior to the greater curvature of the stomach.

[0827] According to one embodiment, the step of placing a continuous purse string roof suture may include placing the continuous purse string roof suture at least in part using a non-barbed suture.

[0828] According to one embodiment, the surgical method step of placing a continuous purse string roof suture may include starting or ending the continuous purse string roof suture at a location at least 0.5 cm from the esophagus.

[0829] According to one embodiment, the surgical method step of placing a continuous purse string roof suture may include placing the continuous purse string roof suture using a suture that terminates in a loop so that the suture can be pulled through the loop to retract the stomach tissue.

[0830] In any of the surgical methods described herein, the step of anchoring the implantable movement restriction device to the fundus may include inserting the implantable movement restriction device into the patient's abdomen. Inserting the implantable movement restriction device into the patient's abdomen may include inserting the implantable movement restriction device into the patient's abdomen using an insertion tool having an elongated abdominal portion.

[0831] According to one embodiment, the surgical method step of securing the implantable movement restriction device to the fundus may include using an instrument having an elongated abdominal portion to push the implantable movement restriction device into the fundus in a dorso-cranial direction. The step of pushing the implantable movement restriction device into the fundus in a dorso-cranial direction using an instrument having an elongated abdominal portion may include pushing the implantable movement restriction device into the fundus in a dorso-cranial direction using the instrument such that a portion of the implantable medical device ends on the dorsal side of the roof suture to position the movement restriction device into the fundus to facilitate subsequent invagination at the top in the fundus position.

[0832] According to one embodiment, the step of anchoring the implantable movement restriction device to the fundus includes placing a continuous purse string base suture in a region of the caudal end of the implantable movement restriction device. The step of placing a continuous purse string bed suture in a region of the caudal end of the implantable movement restriction device may include placing at least two of the continuous purse string bed sutures along an arc. When at least two continuous purse string bed sutures are placed along an arc, the continuous purse string bed sutures may be placed along an arc below the elongated abdominal portion of the instrument that holds the implantable movement restriction device.

[0833] According to one embodiment, the step of placing a continuous purse string base suture in a region of the caudal end of the implantable movement restriction device may include placing the continuous purse string base suture such that the continuous purse string base suture forms a closed curve.

[0834] According to one embodiment, the step of securing the implantable movement restriction device to the fundus may include placing at least one suture or staple from stomach wall to stomach wall over the elongated abdominal portion of the instrument that holds the implantable movement restriction device.

[0835] According to one embodiment, the step of placing a continuous purse string base suture in the region of the caudal end of the implantable movement restriction device may include placing one of the continuous purse string base sutures from stomach wall to stomach wall over the elongated abdominal portion of the apparatus holding the implantable movement restriction device.

[0836] The step of securing the implantable movement restriction device to the base may include releasing the elongated abdominal portion of the apparatus from the implantable movement restriction device.

[0837] According to one embodiment, the step of securing the implantable motion restriction device to the fundus may include placing at least one suture or staple from stomach wall to stomach wall in the area where the elongated abdominal portion of the device was removed to close the hole through which the elongated abdominal portion of the device passed.

[0838] According to one embodiment, the step of placing a continuous purse string base suture in the region of the caudal end of the implantable movement restriction device may include placing the continuous purse string base suture using at least a non-barbed suture to allow for contraction and relaxation of the stomach wall during the surgical procedure.

[0839] According to one embodiment, the step of securing the implantable migration restriction device to the fundus includes contracting a first portion of the stomach wall by pulling a purse string roof suture and contracting a second portion of the stomach wall by pulling a purse string base suture.

[0840] In this manner, the implantable movement restriction device may be anchored to the stomach wall between the first constriction portion and the second constriction portion.

[0841] The surgical method according to any one of the preceding embodiments may further include the step of fixing the implantable movement restriction device to the fundus by invaginating the implantable movement restriction device into the fundus wall from its exterior. The step of invaginating the implantable movement restriction device into the fundus wall may include placing at least two sutures or staples from stomach wall to stomach wall around the implantable movement restriction device to connect the stomach walls, thereby enclosing the implantable movement restriction device within a pouch formed by the fundus stomach wall. The step of invaginating the implantable movement restriction device may include completing the invagination by securing the sutures to the serosa of the stomach wall for long-term fixation.

[0842] According to one embodiment, the step of securing the implantable migration restriction device to the fundus includes measuring the length of the loop formed by the purse string suture roof thread by pulling the purse string suture roof thread to contract a first portion of the stomach wall and securing the purse string suture roof thread to the serosa of the stomach wall.

[0843] There is also provided a surgical method for treating reflux disease, the surgical method comprising the steps of dissecting the esophagus so that it is separated from surrounding tissue at least 3 cm cranial to the angle of His, and anchoring an implantable migration restriction device to the fundus to prevent the lower esophageal sphincter from sliding through the esophageal hiatus.

[0844] According to one embodiment, the surgical method step of dissecting the esophagus includes dissecting the esophagus such that the esophagus is separated from surrounding tissue at least 4 cm cranial to the Angle of His, preferably at least 5 cm cranial to the Angle of His, and most preferably at least 6 cm cranial to the Angle of His.

[0845] According to one embodiment, the surgical method step of dissecting the esophagus so that it is separated from surrounding tissue includes dissecting the esophagus into the mediastinum. The step of dissecting the esophagus into the mediastinum may include dissecting the esophagus into the mediastinum so that it is separated from surrounding tissue at least 1 cm cranial from the distal end of the esophageal hiatus, preferably at least 2 cm cranial from the distal end of the esophageal hiatus, and most preferably at least 3 cm cranial from the distal end of the esophageal hiatus.

[0846] According to one embodiment, the surgical method step of placing at least two posterior sutures or staples on the left posterior side of the esophagus connecting the fundus to the esophagus includes placing at least two continuous sutures on the left posterior side of the esophagus connecting the fundus to the esophagus.

[0847] According to one embodiment, the surgical method step of placing at least two anterior sutures or staples on the left anterior side of the esophagus connecting the fundus to the esophagus includes placing at least two continuous sutures on the left anterior side of the esophagus connecting the fundus to the esophagus.

[0848] In any of the embodiments herein, at least one of the beginning and ending ends of the running suture may be within the serosa of the stomach wall to secure the suture to the serosa of the stomach wall.

[0849] According to one embodiment, the surgical method step of placing at least two posterior sutures or staples on the left posterior side of the esophagus connecting the fundus to the esophagus includes placing at least two lateral sutures on the left posterior side of the esophagus substantially along the cranial-coccygeal axis.

[0850] According to one embodiment, the surgical method ste...

Claims

1. 1. An implantable medical device for treating obesity, the implantable medical device including a movement restriction device configured to be anchored to a stomach wall to prevent movement of a lower esophageal sphincter relative to a thoracic diaphragm, the movement restriction device comprising: a. A central portion; b. at least two outer portions; the central portion and the at least two outer portions are configured to be connected to one another to form at least a portion of a functional movement restriction device, and the central portion and the at least two outer portions are separable from one another such that the central portion and the at least two outer portions can pass independently through the gastrointestinal tract; At least one of the two outer components includes a wedge-shaped portion, the central component includes a wedge-shaped portion, and the wedge-shaped portion of the at least one outer component is configured to be positioned within the wedge-shaped portion of the central component; and at least one outer portion wedge-shaped portion is wedge-shaped with a first angle and a central portion wedge-shaped portion is wedge-shaped with a second angle; and The first angle is greater than the second angle by 3° or more. Implantable medical devices.

2. 10. The implantable medical device of claim 1, wherein the first angle is at least 7 degrees greater than the second angle.

3. 3. The implantable medical device of claim 2, wherein the first angle is at least 10 degrees greater than the second angle.

4. 10. The implantable medical device of claim 1, wherein the first angle is at least 15 degrees greater than the second angle.

5. The implantable medical device of any one of claims 1 to 4, wherein the wedge-shaped portion of at least one outer portion comprises a wedge-shaped recess.

6. The implantable medical device of any one of claims 1 to 4, wherein the wedge-shaped portion of at least one outer portion comprises a wedge-shaped protrusion.

7. The implantable medical device of any one of claims 1 to 4, wherein the wedge-shaped portion of the central portion comprises a wedge-shaped recess.

8. The implantable medical device of any one of claims 1 to 4, wherein the wedge-shaped portion of the central portion includes a wedge-shaped protrusion.

9. 10. The apparatus of any one of the preceding claims, wherein the implantable movement restriction device (110) comprises: a first portion having a first volume surrounded by a material of the implantable movement restriction device (110); a second portion distinct from the first portion, the second portion having a second volume surrounded by material of the implantable movement restriction device (110); the first volume and the second volume are the same size; The first volume has a higher density than the second volume, and the density of the second volume is 1000 kg / m 3 is less than Equipment.

10. The device of claim 9 , wherein the first volume comprises a first solid material.

11. The device of claim 10 , wherein the first solid material comprises a polymeric material.

12. The device of claim 11 , wherein the first solid material comprises at least one of a silicone-based material and a polyurethane-based material.

13. 13. The device of any one of claims 9 to 12, wherein the second volume comprises a second solid material.

14. The device of claim 13 , wherein the second solid material comprises a polymeric material.

15. 15. The device of claim 14, wherein the second solid material comprises at least one of a polypropylene-based material and a polyethylene-based material.

16. The first volume is 1000 kg / m 3 and the second volume comprises a solid material having a density greater than 1000 kg / m 3 16. An apparatus according to any one of claims 13 to 15, comprising a solid material having a density less than

17. 17. The apparatus of any one of claims 9 to 16, wherein the second volume comprises a gas.

18. 18. An apparatus according to any one of claims 9 to 17, wherein the second volume comprises multiple volumes of gas surrounded by surrounding material.

19. 20. The device of claim 18, wherein the second volume comprises a solid polymeric material surrounding the encapsulating material, the encapsulating material being harder than the solid polymeric material.

20. 20. The device of claim 18, wherein the plurality of gas volumes enclosed by the enclosing material occupy at least 10% by volume of the second volume, more preferably at least 20% by volume of the second volume, and even more preferably at least 30% by volume of the second volume.

21. 21. The device of any one of claims 18 to 20, wherein the encapsulating material comprises glass.

22. 10. The apparatus of any preceding claim, wherein the implantable migration restriction device comprises an outer surface configured to rest against a portion of the stomach wall, the outer surface having an average surface roughness of 0.5 μm or less measured on the outer surface.

23. The average surface roughness is R defined according to ISO 21920-2:2021 a 23. The device (100) of claim 22, wherein:

24. The average surface roughness is S, defined according to ISO 25178-2:2021 a 23. The device (100) of claim 22, wherein:

25. The device (100) of any one of claims 22 to 24, wherein the average surface roughness is in the range of 0.1 to 0.5 μm.

26. The device (100) of any one of claims 22 to 25, wherein the average surface roughness is in the range of 0.1 to 0.3 μm.

27. 10. An apparatus according to any one of the preceding claims, wherein the movement restriction device has an indentation hardness of at least 50 on the Shore A scale measured on the outer surface thereof.

28. 28. The device of claim 27, wherein the indentation hardness is the indentation hardness measured by the durometer method defined in Part 4 of ISO 48-4:2018.

29. 29. The device according to any one of claims 27 to 28, having an indentation hardness of 70 or less on the Shore A scale measured on the outer surface.

30. 30. The device of any one of claims 27 to 29, having an indentation hardness on the Shore A scale measured on the outer surface in the range of 55 to 65.

31. 10. The apparatus of any preceding claim, wherein the implantable movement restriction device comprises a contrast agent.

32. 32. The device of claim 31, wherein the contrast agent is BaSO4.

33. 33. The apparatus of claim 31 or 32, wherein the implantable movement restriction device comprises a contrast agent in an amount of 1 to 15% by weight based on the weight of the implantable movement restriction device.

34. 34. The apparatus of claim 33, wherein the implantable movement restriction device comprises a contrast agent in an amount of 1 to 6% by weight of the implantable movement restriction device.

35. 35. The apparatus of claim 34, wherein the implantable movement restriction device comprises a contrast agent in an amount of 8-15% by weight based on the weight of the implantable movement restriction device.

Images