Surgical kit for performing surgical procedures for treating reflux diseases

Abstract

A surgical kit for performing a surgical procedure for treating reflux disease, the surgical kit comprising: an implantable movement limiting device (110, 111a, 111b) configured to prevent movement of a subesophageal sphincter relative to a diaphragm, at least partially interposed between the His angle and the diaphragm; a lubricant comprising at least one antibacterial substance for use with an implantable motion limiting device; and at least one absorbable suture (153).

Description

Technical Field

[0001] The present invention relates generally to medical implants. More specifically, the present invention relates to medical implants for the treatment of gastroesophageal reflux disease (GERD). Background Technology

[0002] Gastroesophageal reflux disease (GERD), also known as reflux disease, is a condition caused by recurrent regurgitation of stomach acid, leading to damage to the esophageal mucosa. GERD can be treated in several different ways, including medication and surgery. One example of surgical treatment is Nissen's fundoplication, which involves wrapping the upper curvature of the stomach (fundus) around the lower esophageal sphincter (LES) to strengthen the sphincter, prevent acid reflux, and repair hiatal hernia. However, this method carries the risk of causing contraction of the food passage, making swallowing more difficult for patients.

[0003] Another example is the Anglechik implant, a horseshoe-shaped device placed around the esophagus above the cardia. The intended effect is to prevent the cardia from sliding upwards into the chest cavity. However, this device can be associated with numerous complications, including perforation and damage to the esophagus. Furthermore, the body often reacts to medical implants, partly because they are foreign bodies and partly because of the mechanical interactions between them and body tissues. Prolonged contact or stress on tissues from an implant can deprive cells of oxygen and nutrients, potentially leading to tissue degeneration, atrophy, and ultimately necrosis.

[0004] Therefore, it would be advantageous to provide more effective and / or less invasive techniques for treating GERD. Summary of the Invention

[0005] One objective of this invention is to overcome or at least mitigate some of the disadvantages associated with the aforementioned treatment of GERD. Additional and / or alternative objectives may be understood from the following description.

[0006] A method is provided for treating reflux disease in a human patient by implanting a motion-limiting device. The motion-limiting device is arranged to restrict the movement of the patient's gastric cardia toward the diaphragm to prevent the cardia from slipping into the patient's thoracic cavity through the diaphragmatic hiatus. The method includes: attaching the fundus of the patient's stomach to the patient's esophagus at a first position; attaching the fundus of the patient's stomach to the patient's esophagus at a second position, the second position being a distance from the first position along the craniocaudate direction; and positioning the motion-limiting device between the first and second positions such that the motion-limiting device is fixed along the craniocaudate direction by the attachment between the fundus and the esophagus at the first and second positions.

[0007] According to one embodiment, prior to the step of attaching the fundus of the patient's stomach to the patient's esophagus at a second position is the step of positioning the motion restriction device between a first position and a second position.

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

[0009] According to one embodiment, the step of attaching the fundus of the patient's stomach to the patient's esophagus at a first position and the step of attaching the fundus of the patient's stomach to the patient's esophagus at a second position are preceded by a step of separating the patient's stomach.

[0010] According to one embodiment, at least one of the steps of attaching the fundus of the patient's stomach to the patient's esophagus at a first position and attaching the fundus of the patient's stomach to the patient's esophagus at a second position is performed using a translaminar device configured for insertion through the patient's esophagus.

[0011] According to one embodiment, the step of positioning the motion-limiting device between a first position and a 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 fundus of the patient's stomach to the patient's esophagus in a first position and attaching the fundus of the patient's stomach to the patient's esophagus in a second position 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 steps of attaching the patient's gastric fundus to the patient's esophagus at a first position may include attaching the patient's gastric fundus to the patient's esophagus at a distance of more than 5 mm, or more than 10 mm, or more than 20 mm, or more than 30 mm from the His angle.

[0014] The step of positioning the motion restriction device between the first position and the second position may include positioning the center of mass of the motion restriction device on a plane extending perpendicular to the craniocaudal direction, at a distance of more than 20 mm or more than 30 mm from the His angle.

[0015] The step of positioning the motion restriction device between the first position and the second position may include positioning the uppermost point of the motion restriction device on a plane extending perpendicular to the craniococcygeal direction, at a distance of more than 5 mm or more than 10 mm from the uppermost point of the cardia.

[0016] The step of positioning the motion restriction device between the first position and the second position may include positioning the center of mass of the motion restriction device on a plane extending perpendicular to the craniococcygeal direction, at a distance of more than 1 mm, more than 5 mm, or more than 10 mm from the uppermost point of the cardia.

[0017] In any embodiment herein, the motion limiting device may have a circular shape, which may be spherical.

[0018] The steps of positioning a motion restriction device may include: positioning the motion restriction device to surround at least 1 / 3 of the esophagus in a plane extending perpendicular to the craniocaudate direction, or positioning the motion restriction device to surround at least 1 / 2 of the esophagus in a plane extending perpendicular to the craniocaudate direction, or positioning the motion restriction device to surround at least 2 / 3 of the esophagus in a plane extending perpendicular to the craniocaudate direction, or positioning the motion restriction device to surround the esophagus in a plane extending perpendicular to the craniocaudate direction.

[0019] The step of positioning the motion-limiting device may include positioning the motion-limiting device, including a curved outer surface, such that the curved outer surface faces the esophagus. The radius of curvature of the curved outer surface may correspond to or exceed the radius of curvature of the esophagus, such that the radius of curvature of the curved outer surface corresponds to or exceeds the radius of curvature of the esophagus.

[0020] The step of positioning a motion restriction device may include positioning the motion restriction device, which includes an electrode arrangement configured to electrically stimulate the muscle tissue and / or serosa of a portion of the gastric fundus to improve the long-term implantation conditions of the motion restriction device.

[0021] In any embodiment, the method may include implanting an implantable energy source configured to provide power to electrodes. The implantable energy source may be disposed within a motion-limiting device or may be implanted subcutaneously. The method may further include implanting an implantable charger configured to be electrically connected to the implantable energy source and capable of charging the implantable energy source from an external energy source.

[0022] The method may further include an implanted controller configured to be operatively connected to the electrode arrangement for controlling electrical stimulation of muscle tissue. The controller may be configured to control the electrical stimulation to subject the muscle tissue to a series of electrical pulses PL1, PL2, PL3, PL4. The electrical stimulation signal may include a pulse frequency of 0.15 to 0.25 Hz, a pulse duration of 20 to 30 ms, and a pulse amplitude of 3 to 10 mA. The controller may include a wireless remote control.

[0023] According to one embodiment, the step of positioning a motion restriction device includes positioning the device having a contracted state and an expanded state, the contracted state for preventing fluid from entering the esophagus from the stomach, and the expanded state for allowing food to enter the stomach in response to a patient's swallowing. The step of positioning the motion restriction device may include positioning the device configured to apply circumferential pressure to the esophagus in the contracted state.

[0024] According to one embodiment, the step of positioning a motion-restricting device includes positioning the motion-restricting device comprising at least one suction device for elastically attracting adjacent portions of the motion-restricting device to generate circumferential pressure. The suction device may include an elastic element or at least two magnets that attract each other. The device may further include a connector linking a first magnet and a second magnet of the at least two magnets to each other.

[0025] The steps of positioning a motion restriction device may include positioning a non-adjustable motion restriction device, or alternatively, positioning a motion restriction device may include positioning a motion restriction device with an adjustable volume.

[0026] The present invention further provides an apparatus for treating reflux disease in human patients. The apparatus includes an implantable motion restriction device, the shape and size of which allow it to be positioned against a portion of the fundus wall of a patient's stomach, such that the motion restriction device is implanted between the patient's diaphragm and a portion of the fundus wall, and restricts the movement of the patient's lower esophageal sphincter toward the diaphragm to prevent the lower esophageal sphincter from slipping into the patient's thoracic cavity through the diaphragmatic hiatus. The apparatus further includes a first electrode arrangement and a second electrode arrangement, the first electrode arrangement being configured to engage and electrically stimulate muscle tissue in the fundus wall portion to exercise the muscle tissue to improve long-term implantation conditions of the motion restriction device, and the second electrode arrangement being configured to engage and electrically stimulate the lower esophageal sphincter to induce contraction of the lower esophageal sphincter.

[0027] According to one embodiment, a first electrode arrangement is disposed on the outer surface of the motion 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 coiled wires to increase the contact surface between the first electrode arrangement and the muscle tissue and to allow the first electrode arrangement to follow the contraction and relaxation of the muscle tissue.

[0029] At least one of the first electrode arrangement and the second electrode arrangement may include a bare electrode portion configured to form a metal-tissue interface with muscle tissue, thereby allowing Faraday charge transfer to become the dominant charge transfer mechanism at the interface.

[0030] At least one of the first electrode arrangement and the second electrode arrangement may include an electrode portion at least partially covered by a dielectric material configured to form a dielectric-tissue interface with muscle tissue, thereby allowing a reduction in the Faraday portion of the charge transfer mechanism at the interface.

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

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

[0033] According to one embodiment, the device may further include an implantable power source configured to provide power to the electrodes. The implantable power source may be disposed, for example, subcutaneously inside or outside the motion restriction device. The implantable power source may include a primary battery and / or a secondary battery.

[0034] The apparatus described in any of the foregoing embodiments may further include a controller configured operably connected to the electrode arrangement for controlling electrical stimulation of muscle tissue. The controller may be configured to control the electrical stimulation to subject the muscle tissue to a series of electrical pulses PL1, PL2, PL3, PL4. The controller may be configured to control the electrical stimulation such that a pulse of first polarity is followed by a pulse of opposite second polarity.

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

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

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

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

[0039] The electrical stimulation signal may include an accumulation period of 0.01 to 2 s with gradually increasing amplitude (X1), a stimulation period of 1 to 60 s (X2), and a stimulation pause of 0.01 to 60 s (X4), wherein the electrical signal includes 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 and may be configured to indicate the functional status of the implantable energy source. The functional status may indicate the electrical level of the implantable energy source.

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

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

[0043] According to one embodiment, the device further includes an implantable charger configured to be electrically connected to an implantable energy source and capable of charging the implantable energy source via 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 the charging of an implantable energy source based on its functional state.

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

[0046] According to one embodiment, the charger is configured to control the charging of the implantable energy source by controlling the transfer 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 of muscle tissue, wherein the controller is configured to control an electrical analog based at least in part on the sensed action potentials, and according to one embodiment, the controller is configured to generate an electrical pulse that amplifies the sensed action potentials.

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

[0049] The motion restriction device may further include an injection port for allowing fluid to be injected into or extracted from the interior of the motion restriction device to change the volume of the motion restriction device after implantation.

[0050] Motion restriction devices may include a biocompatible outer surface configured to rest against a portion of the gastric fundus wall.

[0051] Movement restriction devices can be basically spherical or egg-shaped.

[0052] The movement restriction device can be configured to be at least partially enclosed by the gastric fundus wall.

[0053] In any of the embodiments herein, the motion restriction device may be configured to be introduced into the patient’s body via an endoscope or endoscopic instrument.

[0054] The motion-limiting device can be configured to change its shape during insertion into the patient's body to allow it to pass through the cannula.

[0055] According to one embodiment, the motion restriction device is formed of at least two different and separable components, which are configured to be assembled into a motion restriction device after being inserted into the patient's body.

[0056] In any embodiment herein, the minimum width of the motion restriction device, measured from one side to the other, may be 20 mm or greater, or 30 mm or greater, such as 40 mm or greater.

[0057] The minimum outer circumference of the motion restriction device can be 150mm or less, such as 130mm or less, such as 110mm or less, such as 90mm or less, such as 70mm or less, such as 50mm or less, such as 30mm or less.

[0058] The present invention further provides an apparatus for treating reflux disease in human patients. The apparatus includes an implantable motion restriction device configured to be fixed between the upper part of the patient's stomach and the diaphragm to restrict movement of the patient's cardia toward the diaphragm. The implantable motion restriction device has a first cross-sectional distance and a second cross-sectional distance, and is configured to be implanted such that the first cross-sectional distance is parallel to, but not perpendicular to, the patient's craniocausal axis, and the second cross-sectional distance is perpendicular to, but not parallel to, the patient's craniocausal axis. The implantable motion restriction device is adjustable in situ so that the shape of the implantable motion 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 motion restriction device can be adjusted by increasing the length of the first cross-sectional distance relative to the second cross-sectional distance while keeping the perimeter of the cross-section of the implantable motion restriction device located in a plane parallel to the patient's coronal plane constant.

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

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

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

[0063] According to one embodiment, the implantable motion restriction device includes an upper portion configured to engage directly or indirectly with a patient's diaphragm, wherein the upper portion includes at least one curvature.

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

[0065] Implantable motion restriction devices can be configured to be at least partially enclosed by the stomach wall at the fundus of the stomach.

[0066] According to one embodiment, the motion restriction device includes a curved cross-section located on a plane parallel to the patient's cross-section. This curved surface may be configured to partially surround the patient's esophagus. According to one embodiment, the motion restriction device is configured to surround at least one-third of the esophagus on a plane parallel to the patient's cross-section; in another embodiment, the motion restriction device is configured to surround at least one-half of the esophagus on a plane parallel to the patient's cross-section; in yet another embodiment, the motion restriction device includes a C-shaped cross-section located on a plane parallel to the patient's cross-section, and the C-shaped cross-section is configured to partially surround the patient's esophagus; in yet another embodiment, the motion restriction device is configured to surround at least two-thirds of the esophagus on a plane parallel to the patient's cross-section.

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

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

[0069] The motion limiting device may include an injection port, allowing adjustment of the hydraulically adjustable motion limiting device by injecting or withdrawing hydraulic fluid from it. A portion of the motion limiting device may include a bellows, wherein the length of the bellows is adjusted by injecting or withdrawing hydraulic fluid from the hydraulically adjustable motion limiting device.

[0070] According to one embodiment, the motion limiting device includes a wall surrounding a hydraulic adjustment chamber, and the thickness of the wall changes when fluid is injected into or extracted from the motion limiting device, thus affecting the shape of the motion limiting device.

[0071] According to one embodiment, the shape of the motion limiting device is altered by causing a thinner portion of the wall surrounding the hydraulic regulating cavity to deform more than a thicker portion of the wall surrounding the hydraulic regulating cavity.

[0072] According to one embodiment, the motion restriction device is mechanically adjustable and may include mechanical operating devices.

[0073] According to one embodiment, the motion limiting device includes a transmission element configured to transmit at least one of electrical energy and mechanical force to the mechanically adjustable motion limiting device.

[0074] According to one embodiment, the transmission element includes at least one of the following: an electrical lead, a shaft for transmitting rotational force, and a shaft for transmitting linear force.

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

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

[0077] According to one embodiment, a portion of the motion limiting device includes a bellows, and the operation of the mechanical operating device adjusts the length of the bellows.

[0078] In other embodiments, the motion restriction device is electrically adjustable.

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

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

[0081] According to one embodiment, the length of the first cross-section distance can be adjusted in situ such that the length of the first cross-section distance is 1.2 times, 1.3 times, or 1.5 times the length of the second cross-section distance.

[0082] According to one embodiment, the length of the first cross-sectional distance can be adjusted in situ such that the perimeter of the cross-section of the implantable motion restriction device located on a plane parallel to the patient's coronal plane is 1.2 times, or 1.3 times, or 1.5 times the perimeter of the cross-section of the implantable motion restriction device located on a plane parallel to the patient's transverse plane.

[0083] According to one embodiment, the length of the first cross-sectional distance can be adjusted in situ such that the position of the centroid of the motion restriction device on a plane parallel to the patient's cross-section is more than 20 mm or more than 30 mm away from the angle His.

[0084] According to one embodiment, the length of the first cross-sectional distance can be adjusted in situ, such that the distance between the centroid of the motion restriction device on the plane parallel to the patient's cross-section and the uppermost point of the cardia exceeds 5 mm or 10 mm.

[0085] In any embodiment herein, the motion restriction device may include at least two components.

[0086] In any embodiment herein, the device may further include an implantable power source configured to provide power to the adjustable implantable motion restriction device. The implantable power source may be disposed inside the motion restriction device or subcutaneously.

[0087] In any embodiment 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 motility limiting device has a contracted state and an expanded state, the contracted state for preventing fluid from entering the esophagus from the stomach, and the expanded state for allowing food to enter the stomach in response to a patient's swallowing. The motility limiting device may include at least one suction device for elastically aspirating adjacent portions of the motility limiting device to generate circumferential pressure on the esophagus, and the suction device may include an elastic element.

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

[0090] The present invention further provides an apparatus for treating reflux disease in human patients. The apparatus includes an implantable motion restriction device configured to be fixed between the upper part of the patient's stomach and the diaphragm to restrict movement of the patient's cardia toward the diaphragm. The implantable motion restriction device includes a first portion and a second portion different from the first portion. The first portion has a first volume surrounded by a material of the implantable motion restriction device, and the second portion has a second volume surrounded by a material of the implantable motion restriction device. The first volume and the second volume are equally large, and the density of the first volume is higher than that of the second volume, and the density of the second volume is less than 1000 kg / m³.

[0091] According to one embodiment, the first volume includes a first solid material, and the first solid material may include a polymer 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, and the second solid material may include a polymer material. The second solid material may include at least one of a polypropylene-based material and a polyethylene-based material.

[0094] The first volume may include solid materials with a density higher than 1000 kg / m3, and the second volume may include solid materials with a density lower than 1000 kg / m3.

[0095] According to one embodiment, the second volume includes a fluid, which may be a liquid with a density of less than 1000 kg / m3, such as a liquid selected from a list of oil-based liquids and alcohol-based liquids.

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

[0097] According to one embodiment, the second volume includes a solid polymer material surrounding the surrounding material, and the surrounding material is harder than the solid polymer material.

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

[0099] The surrounding material may include glass.

[0100] According to one embodiment, the average density of the motion restriction device is less than 1100 kg / m3, or less than 1050 kg / m3, or less than 1000 kg / m3.

[0101] According to one embodiment, the motion restriction device includes a first cross-sectional distance and a second cross-sectional distance. The implantable motion restriction device can be configured to be implanted such that the first cross-sectional distance is parallel to, but not perpendicular to, the patient's cranio-coccygeal axis, and the second cross-sectional distance is perpendicular to, but not parallel to, the patient's cranio-coccygeal axis. The implantable motion restriction device can be adjusted in situ so that the shape of the implantable motion 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 increase relative to the length of the second cross-sectional distance.

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

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

[0104] According to one embodiment, the implantable motion restriction device includes an upper portion configured to engage directly or indirectly with a patient's diaphragm, wherein the upper portion includes at least one curvature.

[0105] In any of the embodiments described herein, the implantable motion restriction device may be at least partially enclosed within the stomach wall.

[0106] According to one embodiment, the implantable motion restriction device is configured to be at least partially enclosed by the stomach wall of the gastric fundus.

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

[0108] In any embodiment herein, an implantable motion restriction device may include at least two components, and the at least two components may be configured to assemble to form an implantable motion restriction device. The at least two components may be configured to connect to each other to form an implantable motion restriction device.

[0109] According to one embodiment, the device further includes an interconnecting component configured to connect with the at least two components, and at least one of the two components and the interconnecting component includes a connecting recess and at least one of the two components and the interconnecting component includes a connecting protrusion, wherein at least one connecting protrusion and a connecting recess are configured to interconnect to form an implantable motion restriction device.

[0110] According to one embodiment, the motion restriction device includes a curved cross-section located on a plane parallel to the patient's cross-section, wherein the curved surface is configured to partially surround the patient's esophagus.

[0111] According to one embodiment, the motion restriction device is configured to surround at least 1 / 3 of the esophagus in a plane parallel to the patient's cross-section, or to surround at least 1 / 2 of the esophagus in a plane parallel to the patient's cross-section, or to surround 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 includes a C-shaped section located on a plane parallel to the patient's cross-section, wherein the C-shaped section is configured to partially surround the patient's esophagus.

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

[0114] According to one embodiment, the motility restriction device includes a contracted state and a distended state, the contracted state for preventing fluid from entering the esophagus from the stomach, and the distended state for allowing food to enter the stomach in response to a patient's swallowing. The motility restriction device may include at least one suction device for elastically aspirating adjacent portions of the device to generate circumferential pressure within the esophagus. The suction device may include an elastic element or at least two mutually attracting magnets.

[0115] The present invention further provides an apparatus for treating reflux disease in a human patient. The apparatus includes an implantable motion restriction device configured to be at least partially enclosed by the patient's stomach wall to restrict movement of the patient's cardia toward the diaphragm. The implantable motion 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 greater than 1.5 times the second length. The implantable motion restriction device is configured to be implanted such that the first cross-sectional distance is parallel to, but not perpendicular to, the patient's cranio-coccygeal axis, and the second cross-sectional distance is perpendicular to, but not parallel to, the patient's cranio-coccygeal axis. The implantable motion restriction device includes at least a first component and a second component configured to connect to form the implantable motion restriction device. The center of gravity of the first component is located on a plane extending vertically from a first half of the first cross-sectional distance, and the center of gravity of the second component is located on a plane extending vertically from a second half of the first cross-sectional distance. The lower portion of the first component includes a first connecting portion, and the upper portion of the second component includes a second connecting portion. The first connecting portion and the second connecting portion are configured to be connected to each other and configured to be enclosed in the patient's stomach wall by an implantable motion limiting device so that at least one of the first and second portions is supported or compressed to maintain the connection with each other, and the first and second portions are capable of disconnecting and separating when the support or compression of at least one of the first and second portions by the stomach wall is reduced.

[0116] The first connection portion and the second connection portion can be configured to be directly connected to each other, or they can be configured to be indirectly connected to each other through interconnecting components.

[0117] According to one embodiment, at least one of the first component, the second component, and the interconnecting component includes a connecting recess, and at least one of the first component, the second component, and the interconnecting component includes a connecting protrusion, wherein at least one connecting protrusion and a connecting recess are configured to interconnect to form an implantable motion restriction device.

[0118] According to one embodiment, at least one of the first connecting portion and the second connecting portion includes an elastic connecting portion, wherein the elastic connecting portion is supported or compressed directly or indirectly through an implantable movable incorporation to directly or indirectly connect the first component to the second component.

[0119] According to one embodiment, the resilient connection portion includes a resilient protrusion configured to engage with a recess to directly or indirectly connect the first component to the second component. The resilient protrusion may be configured to connect to and disconnect from the recess in a direction substantially perpendicular to the direction of the distance from the first cross-section.

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

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

[0122] According to one embodiment, the first sub-component and the second sub-component are configured to be encased in the patient's stomach wall by an implantable motion-limiting device, such that at least one of the first and second sub-components is supported or compressed to remain connected to each other, wherein the first and second sub-components are capable of disconnecting and separating from each other if the support or compression of at least one of the first and second sub-components by the stomach wall is reduced.

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

[0124] According to one embodiment, the second component is configured to apply a supporting or compressive force to the first component, the supporting or compressive force originating from the supporting or compressive force applied by the stomach wall to the second component.

[0125] According to one embodiment, the first component includes a first sub-component and a second sub-component, the second component includes the first sub-component and the second sub-component, and the first and second sub-components of the first component are configured to be connected to each other by a supporting force or compressive force applied by at least one of the second component and the stomach wall. The first and second sub-components of the second component are also configured to be connected to each other by a supporting force or compressive force applied by the stomach wall.

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

[0127] According to one embodiment, the second component is configured to apply a supporting or compressive force to the first component, the supporting or compressive force originating from a supporting or compressive force applied to the second component by the third component. The third component may be configured to apply a supporting or compressive force to the second component, the supporting or compressive force originating from a supporting or compressive force applied to the third component by the stomach wall.

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

[0129] According to one embodiment, the first elastic connection portion and the second elastic connection portion are supported or compressed by a supporting force or compressive force applied to the second component by the third component.

[0130] According to one embodiment, a first component includes a first sub-component and a second sub-component, a second component includes both the first and second sub-components, and a third component includes both the first and second sub-components. The first and second sub-components of the first component are configured to be connected to each other by a supporting or compressive force applied by at least one of the second component and the stomach wall; the first and second sub-components of the second component are configured to be connected to each other by a supporting or compressive force applied by at least one of the third component and the stomach wall; and the first and second sub-components of the third component are configured to be connected to each other by a supporting or compressive force applied by the stomach wall.

[0131] According to one embodiment, the first component includes a first sub-component, a second sub-component, and a third sub-component, and / or the second component includes the first sub-component, the second sub-component, and the third sub-component, and / or the third component includes the first sub-component, the second sub-component, and the third sub-component.

[0132] According to one embodiment, the first component includes a first sub-component, a second sub-component, a third sub-component, and a fourth sub-component, and / or the second component includes the first sub-component, the second sub-component, the third sub-component, and the fourth sub-component, and / or the third component includes the first sub-component, the second sub-component, the third sub-component, and the fourth sub-component.

[0133] According to one embodiment, the motion limiting device is elongated, and the first length is greater than twice the second length, preferably greater than 2.5 times the second length, and even more preferably greater than three times the second length.

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

[0135] An implantable motion restriction device may include a first section, a second section, and a third section located on a plane spaced apart from and parallel to each other, wherein the first and third sections have the same area, and the second section is located between the first and third sections and has a smaller area. According to one embodiment, the implantable motion restriction device further includes a fourth and a fifth section located on a plane spaced apart and parallel to the planes of the first, second, and third sections, wherein the third and fifth sections have the same area, and the fourth section is located between the third and fifth sections and has a smaller area.

[0136] According to one embodiment, the implantable motion restriction device can be configured to be fully enclosed.

[0137] The first part of the implantable motion restriction device may have a first volume surrounded by the material of the implantable motion restriction device, and the second part of the motion restriction device, which is separate from the first part, may have a second volume surrounded by the material of the implantable motion restriction device. The first volume and the second volume are of equal size, and the density of the first volume is higher than that of the second volume and the density of the second volume is less than 1000 kg / m3.

[0138] According to one embodiment, the first volume includes a first solid material, and the first solid material may include polymer materials such as silicone-based materials or polyurethane-based materials.

[0139] According to one embodiment, the second volume includes a second solid material. The second solid material may include polymeric materials such as polypropylene-based materials and polyethylene-based materials.

[0140] In any embodiment herein, the first volume may include a solid material with a density greater than 1000 kg / m³, and the second volume may include a solid material with a density less than 1000 kg / m³.

[0141] In any embodiment herein, the second volume may include a fluid, such as an oil-based liquid or an alcohol-based liquid, with a density of less than 1000 kg / m³.

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

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

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

[0145] The surrounding material may include glass.

[0146] According to one embodiment, the average density of the motion restriction device is less than 1100 kg / m3, or less than 1050 kg / m3, or less than 1000 kg / m3.

[0147] According to one embodiment, the motion restriction device includes a first cross-sectional distance and a second cross-sectional distance. The implantable motion restriction device can be adjusted in situ so that the shape of the implantable motion 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 increase relative to the length of the second cross-sectional distance.

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

[0149] In any embodiment herein, the first component may include an upper portion configured to engage directly or indirectly with the patient’s diaphragm, and the upper portion may include at least one curvature.

[0150] The present invention further provides an apparatus for treating reflux disease in human patients. The apparatus includes an implantable motion restriction device configured to be at least partially enclosed within the patient's stomach wall to restrict movement of the patient's cardia toward the diaphragm. The implantable motion restriction device includes a sensor configured to sense at least one of force and pressure for monitoring the pressure or force exerted by the implantable motion restriction device on the patient's stomach wall.

[0151] According to one embodiment, the sensor is fixed to the surface of an implantable motion restraint device and / or integrated into the implantable motion restraint 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 motion restriction device includes at least one closed cavity containing fluid, and a sensor is configured to sense pressure in the fluid. The device may further include at least one conduit and a sensor unit configured to house the sensor, and the conduit may be fluidly connected to the closed cavity of the implantable motion restriction device and the sensor unit, such that the sensor can sense the fluid pressure in the closed cavity of the implantable motion restriction device through the fluid connection provided by the conduit.

[0153] According to one embodiment, the device further includes an implantable power source for powering the sensor and an implantable controller connected to the sensor. The implantable controller may include a wireless transceiver configured to receive sensor signals from the sensor and transmit wireless signals derived from the sensor signals to a unit outside the patient's body.

[0154] According to one embodiment, the size of the implantable motion restriction device is such that it can be completely enclosed by the patient's gastric fundus.

[0155] The device may further include at least one lead connected to the sensor, and the lead may be 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 detachably connecting the sensor to the lead, allowing the lead to be disconnected from the sensor.

[0156] In alternative embodiments, the sensor can be detachably attached to the implantable motion restriction device, allowing the sensor to be detached from the implantable motion restriction device by pulling the lead wire, and the sensor can be detachably attached to the implantable motion restriction device using adhesive.

[0157] In any embodiment herein, the volume of the implantable motion restriction device is in the range of 0.3 cm³ to 6.6 cm³, or in the range of 0.5 cm³ to 7.3 cm³, or in the range of 3 cm³ to 8 cm³, or in the range of 2.5 cm³ to 6.6 cm³, or in the range of 4 cm³ to 7.3 cm³.

[0158] According to one embodiment, the motion limiting device is elongated, and a first cross-sectional distance has a first length and a second cross-sectional distance has a second length. The first length is greater than 1.2 times the second length, preferably greater than 1.5 times the second length, and even more preferably greater than 2 times the second length.

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

[0160] According to one embodiment, the implantable motion restriction device includes a first cross-section, a second cross-section, and a third cross-section located on parallel planes spaced apart from each other. The first and third cross-sections have the same area, and the second cross-section is located between the first and third cross-sections and has a smaller area.

[0161] According to one embodiment, the implantable motion restriction device includes at least two components, at least three components, or at least four components.

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

[0163] According to one embodiment, the motion restriction device includes a curved cross-section located on a plane parallel to the patient's cross-section, and the curved surface is configured to partially surround the patient's esophagus.

[0164] According to one embodiment, the motion restriction device includes a curved cross-section located on a plane parallel to the patient's cross-section. This curved surface may be configured to partially surround the patient's esophagus. According to one embodiment, the motion restriction device is configured to surround at least one-third of the esophagus on a plane parallel to the patient's cross-section; in another embodiment, the motion restriction device is configured to surround at least one-half of the esophagus on a plane parallel to the patient's cross-section; in yet another embodiment, the motion restriction device includes a C-shaped cross-section located on a plane parallel to the patient's cross-section, and the C-shaped cross-section is configured to partially surround the patient's esophagus; in yet another embodiment, the motion restriction device is configured to surround at least two-thirds of the esophagus on a plane parallel to the patient's cross-section.

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

[0166] In any of the embodiments, the implantable motion restriction device may include at least one circular cross-section.

[0167] A surgical instrument is further provided for assisting in the implantation of an implantable motion-limiting device. The motion-limiting device is configured to be at least partially enclosed within the patient's stomach wall to restrict movement of the patient's cardia toward the diaphragm. The surgical instrument includes: an actuating 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 wire 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, for monitoring the pressure or force exerted by the implantable motion-limiting device on the patient's stomach wall during implantation.

[0168] According to one embodiment, the distal portion includes a retaining device connected to the manipulator portion and configured to be inserted into the patient's body and engage with the motion restriction device.

[0169] According to one embodiment, the retaining device includes an elongated portion configured to be inserted into an implantable motion-limiting device.

[0170] According to one embodiment, the retaining device includes a clamping portion configured to clamp an implantable motion restriction device.

[0171] The surgical instrument can be configured for inserting an implantable motion-limiting device, and the surgical instrument further includes a cannula connected to an actuating portion, and a retaining device configured to be partially placed within the cannula and displaceable relative to the cannula. Actuation of the actuating portion causes relative displacement of the retaining device relative to the cannula, thereby disengaging the retaining device from the motion-limiting device to facilitate insertion of the motion-limiting device.

[0172] According to one embodiment, the distal portion is bent relative to the main length axis of the surgical instrument, and the distal portion may be bent more than 20° relative to the main 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 can be controlled from the manipulating portion.

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

[0176] According to one embodiment, the surgical instrument further includes a sensor. The sensor can be configured to be detachably attached to the implantable motion restriction device, such that the sensor can be detached from the implantable motion restriction device and removed from the patient's body during surgical procedures.

[0177] According to one embodiment, the sensor is configured to attach to the surface of or within an implantable motion restriction device. The sensor may be configured to be detachably attached to the implantable motion restriction device using an adhesive. The surgical instrument may further include a connector for detachably connecting the sensor to a lead, such that the lead can be disconnected from the sensor. 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, or a capacitive sensor, or an electromagnetic sensor.

[0178] According to one embodiment, the implantable motion restriction device includes at least one closed cavity containing fluid, and the sensor is a sensor configured to sense pressure in the fluid.

[0179] According to one embodiment, the surgical instrument further includes a power 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's body during use of the surgical instrument, and the controller is configured to receive sensor signals from the sensor via leads and provide outputs based on the sensor signals.

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

[0181] A further device for treating reflux disease in human patients is provided, comprising an elongated core of such length that it at least partially encircles the patient's esophagus. The core includes a first variable-length functional portion and a second variable-length functional portion, the first allowing the core to be arranged in a contracted state to prevent fluid from entering the esophagus from the stomach 10 and in an expanded state to allow food to enter the stomach in response to the patient's swallowing; the second variable-length functional portion is used to adjust the length of the core in the contracted state postoperatively.

[0182] According to one embodiment, the second variable-length functional section includes a hydraulically variable-length functional section and may include at least one hydraulic chamber, and the length of the core can be adjusted postoperatively by injecting fluid into or withdrawing fluid 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 cavity, and the change in wall thickness affects the shape of the hydraulic cavity when fluid is injected into or extracted from the hydraulic cavity.

[0184] According to one embodiment, the shape of the motion limiting device can be altered by causing a thinner portion of the wall surrounding the hydraulic regulating cavity to deform more than a thicker portion of the wall surrounding the hydraulic regulating cavity.

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

[0186] According to one embodiment, the second variable length functional unit includes a mechanically variable length functional unit, and the mechanically variable length functional unit may include a power-driven mechanically variable length functional unit.

[0187] According to one embodiment, the power-driven variable-length mechanical functional part may include at least one of an electric motor, an electromagnet, and an electroactive material.

[0188] According to one embodiment, the motion limiting device includes a transmission element configured to transmit at least one of electrical energy and mechanical force to a mechanically variable length functional part.

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

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

[0191] According to one embodiment, the first variable-length functional section includes a plurality of parts that can move relative to each other.

[0192] According to one embodiment, the first variable-length functional section includes an attractor for elastically attracting adjacent portions of the elongated core to each other. The attractor may include an elastic element, or may include at least two mutually attracting magnets.

[0193] According to one embodiment, the device further includes a connector that connects the first magnet and the second magnet of the at least two magnets to each other.

[0194] According to one embodiment, the elongated core is configured to apply circumferential pressure to the esophagus in a contracted state.

[0195] According to one embodiment, the device includes two end portions configured to connect with each other to form a closed loop around the esophagus, and the end portions may be configured to be releasably attached to each other and may include corresponding interlocking attachers.

[0196] According to one embodiment, the elongated core includes a plurality of bodies configured to be arranged in a ring array around the esophagus.

[0197] According to one embodiment, the elongated core further includes a plurality of connectors, each of which extends between a corresponding pair of bodies arranged adjacent to each other.

[0198] According to one embodiment, at least one of the plurality of bodies includes a second length-variable functional portion for adjusting the length of the core in a contracted state after surgery.

[0199] According to one embodiment, at least one of the plurality of bodies includes a hydraulic chamber for adjusting the length of the core in a contracted state after surgery.

[0200] The size of the elongated core allows at least a portion of it to protrude above the patient's pyloric sphincter upon implantation, thus restricting the movement of the pylorus toward the diaphragm and preventing it from sliding into the patient's thoracic cavity through the diaphragmatic hiatus 32.

[0201] According to one embodiment, the maximum height of the elongated core exceeds 2 cm when measured along the normal direction of the plane in which the elongated core extends as it surrounds the esophagus. In alternative embodiments, the maximum height may be 3 cm or greater, such as 4 cm or greater, such as 5 cm or greater.

[0202] According to one embodiment, the elongated core is configured to be implanted such that the portion of the elongated core with the maximum height is positioned on the gastric fundus side of the esophagus.

[0203] According to one embodiment, the elongated core has a first cross-sectional distance and a second cross-sectional distance, wherein the elongated core is configured to be implanted such that the first cross-sectional distance is parallel to but not perpendicular to the patient's cranio-coccygeal axis and the second cross-sectional distance is perpendicular to but not parallel to the patient's cranio-coccygeal axis, and the elongated core is adjustable in situ so that the shape of the elongated core 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.

[0204] According to one embodiment, the shape of the elongated core can be adjusted by increasing the length of the first cross-sectional distance relative to the second cross-sectional distance while keeping the perimeter of the cross-section of the elongated core located on a plane parallel to the patient's coronal plane unchanged.

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

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

[0207] According to one embodiment, the elongated core includes an upper portion configured to engage directly or indirectly with the patient's diaphragm, and the upper portion includes at least one curvature.

[0208] In any embodiment herein, the elongated core may be configured to be at least partially enclosed by the stomach wall.

[0209] According to one embodiment, the elongated core is configured to be at least partially enclosed by the stomach wall of the gastric fundus.

[0210] According to one embodiment, the motion restriction device includes a curved cross-section located on a plane parallel to the patient's cross-section. This curved surface may be configured to partially surround the patient's esophagus. According to one embodiment, the motion restriction device is configured to surround at least one-third of the esophagus on a plane parallel to the patient's cross-section; in another embodiment, the motion restriction device is configured to surround at least one-half of the esophagus on a plane parallel to the patient's cross-section; in yet another embodiment, the motion restriction device includes a C-shaped cross-section located on a plane parallel to the patient's cross-section, and the C-shaped cross-section is configured to partially surround the patient's esophagus; in yet another embodiment, the motion restriction device is configured to surround at least two-thirds of the esophagus on a plane parallel to the patient's cross-section.

[0211] In any embodiment herein, the second variable length functional section may be configured to adjust the length of the core in its contracted state by more than 5%, or more than 10%, or more than 15%, or more than 20% postoperatively.

[0212] In any embodiment herein, the device may include at least one electrode for electrically stimulating at least one tissue portion of a patient.

[0213] The present invention further provides a device for treating reflux disease in human patients. The device includes an elongated core, the length of which allows the elongated core to at least partially surround the patient's esophagus. The elongated core includes: a first variable-length functional portion and a second variable-length functional portion, the first variable-length functional portion allowing the core to be arranged in a contracted state to prevent fluid from entering the esophagus from the stomach and in an expanded state to allow food to enter the stomach in response to the patient's swallowing; and a protruding portion configured to protrude from the first variable-length functional portion in a direction parallel to, rather than perpendicular to, the patient's craniocausal axis in a substantially craniolateral direction when the elongated core is implanted. The protruding portion is configured to protrude at least 10 mm in a plane extending perpendicular to the patient's craniocausal axis and including the center of gravity of the elongated core in the substantially craniolateral direction, and the protruding portion is configured to directly or indirectly engage the patient's diaphragm to restrict the movement of the patient's cardia.

[0214] The protruding portion can extend at least 20 mm along the basic cranial lateral direction from a plane that extends perpendicular to the patient's cranio-coccygeal axis and includes the center of gravity of the elongated core.

[0215] The protrusion can be configured to extend a certain distance along the basic cranial direction from a plane that extends perpendicular to the patient's cranio-coccygeal axis and includes the center of gravity of the elongated core, such that the upper portion of the protrusion is positioned at least 5 mm above the pyloric sphincter.

[0216] The protrusion can be configured to extend a certain distance along the basic cranial lateral direction from a plane that extends perpendicular to the patient's cranio-coccygeal axis and includes the center of gravity of the elongated core, such that the upper portion of the protrusion is positioned at least 10 mm above the pyloric sphincter.

[0217] The protrusion can be configured to extend a certain distance along the basic cranial direction from a plane that extends perpendicular to the patient's cranio-coccygeal axis and includes the center of gravity of the elongated core, such that the upper portion of the protrusion is positioned at least 15 mm above the pyloric sphincter.

[0218] The slender core may have a first cross-sectional area on a first plane extending perpendicular to the patient's cranio-coccygeal axis, and the protruding portion may have a second cross-sectional area on a second plane parallel to the first plane, and the first cross-sectional area may be greater than 1.5 times the second cross-sectional area.

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

[0220] According to one embodiment, the protruding portion has a third cross-sectional area on a third plane parallel to the first plane, and the second plane is located between the first plane and the third plane, and the third cross-sectional area is greater than 1.5 times the second cross-sectional area.

[0221] According to one embodiment, the device further includes a second elongated core, the length of which allows the second elongated core to at least partially encircle the patient's esophagus. A protruding portion can connect the first elongated core to the second elongated core.

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

[0223] According to one embodiment, the protruding portion includes an upper portion configured to engage directly or indirectly with the patient's diaphragm, and the upper portion includes at least one curvature.

[0224] According to one embodiment, at least one of the first elongated core, the second elongated core, and the protruding portion can be configured to be at least partially enclosed by the stomach wall.

[0225] According to one embodiment, the protrusion is adjustable in situ, allowing adjustment of the length of the protrusion extending from a plane perpendicular to the patient's cranio-coccygeal axis and including the center of gravity of the elongated core. The protrusion may be hydraulically adjustable and may further include a catheter 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 elongated core includes an injection port, such that the hydraulically adjustable protrusion can be adjusted by injecting or withdrawing hydraulic fluid into or from the injection port.

[0227] According to one embodiment, the protruding portion includes a bellows, and the length of the bellows can be adjusted to allow hydraulic fluid to be injected into or withdrawn from the injection port.

[0228] According to one embodiment, the protrusion includes a wall surrounding the hydraulic regulating cavity, and the change in wall thickness affects the shape of the protrusion when fluid is injected into or withdrawn from the protrusion. The shape of the protrusion can be changed by making the thinner portion of the wall surrounding the hydraulic regulating cavity deform more than the thicker portion of the wall surrounding the hydraulic regulating cavity.

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

[0230] According to one embodiment, the motion restriction device includes a transmission element configured to transmit at least one of electrical energy and mechanical force to a 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 a motor and may include a transmission configured to convert the rotational force generated by the motor into a linear force for adjusting the length of the protrusion.

[0233] One part of the protruding section includes a bellows, the length of which is adjusted by the operation of a mechanical device.

[0234] According to one embodiment, the protruding portion is electrically adjustable, and the device may include at least one material configured to change shape upon exposure to current or voltage. The material may be at least one electroactive polymer selected from the list of electroactive polymers consisting of ferroelectric polymers, electrostrictive grafted polymers, electrostrictive paper, piezoelectric polymers, and liquid crystal elastomers.

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

[0236] According to one embodiment, the elongated core includes a curved cross-section located on a plane parallel to the patient's cross-section, wherein the curved surface is configured to partially surround the patient's esophagus.

[0237] According to one embodiment, the motion restriction device includes a curved cross-section located on a plane parallel to the patient's cross-section. This curved surface may be configured to partially surround the patient's esophagus. According to one embodiment, the motion restriction device is configured to surround at least one-third of the esophagus on a plane parallel to the patient's cross-section; in another embodiment, the motion restriction device is configured to surround at least one-half of the esophagus on a plane parallel to the patient's cross-section; in yet another embodiment, the motion restriction device includes a C-shaped cross-section located on a plane parallel to the patient's cross-section, and the C-shaped cross-section is configured to partially surround the patient's esophagus; in yet another embodiment, the motion restriction device is configured to surround at least two-thirds of the esophagus on a plane parallel to the patient's cross-section.

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

[0239] According to one embodiment, the first variable-length functional section includes an attractor for elastically attracting adjacent portions of the elongated core to each other. The attractor may include an elastic element or at least two mutually attracting magnets. The device may further include a connector linking a first magnet and a second magnet of the at least two magnets to each other.

[0240] According to one embodiment, the elongated core is configured to apply circumferential pressure to the esophagus in a contracted state.

[0241] According to one embodiment, the device includes two end portions configured to connect with each other to form a closed loop around the esophagus. The end portions may be configured to be releasably attached to each other and may include corresponding interlocking attachers.

[0242] The elongated core may include multiple bodies configured to be arranged in a ring array around the esophagus.

[0243] According to one embodiment, the elongated core further includes a plurality of connectors, each of which extends between a corresponding pair of bodies arranged adjacent to each other.

[0244] According to one embodiment, the elongated core is configured to be implanted with its protruding portion positioned on the gastric fundus side of the esophagus.

[0245] The device may further include a second variable length functional section configured to adjust the length of the elongated core in its contracted state by more than 5%, or more than 10%, or more than 15%, or more than 20% postoperatively.

[0246] In any embodiment herein, the device may include at least one electrode for electrically stimulating at least one tissue portion of a patient.

[0247] A further method is provided for treating reflux disease in a human patient by implanting a motion-limiting device. The motion-limiting device is arranged to restrict the movement of the patient's gastric cardia toward the diaphragm to prevent the cardia from slipping into the patient's thoracic cavity through the diaphragmatic hiatus. The motion-limiting device includes a curved inner surface configured to face a curved outer surface of the esophagus. The method includes positioning and securing the motion-limiting device such that the curved inner surface surrounds at least one-third of the esophagus in a plane perpendicular to the craniocaudal axis, and the center of mass of the motion-limiting device lies in a plane perpendicular to the craniocaudal axis, wherein the shortest distance from a point in this plane to the His angle exceeds 20 mm.

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

[0249] The procedure of attaching the patient's gastric fundus to the patient's esophagus at a first position may include attaching the patient's gastric fundus to the patient's esophagus at a distance of more than 5 mm from the His angle.

[0250] According to one embodiment, the step of positioning and fixing the motion restriction device includes positioning and fixing the motion restriction device such that the uppermost point of the motion restriction device is placed on 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 exceeds 40 mm.

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

[0252] According to one embodiment, the step of positioning and fixing the motion restriction device includes positioning and fixing the motion restriction device such that the lowest point of the motion restriction device is placed on a third plane extending perpendicular to the cranio-coccygeal axis, wherein the shortest distance from a point on the third plane to the His angle exceeds 10 mm.

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

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

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

[0256] According to one embodiment, the steps of positioning and fixing the motion restriction device include positioning the center of mass of the motion restriction device on a second plane extending perpendicular to the craniococcygeal direction, wherein the shortest distance from a point on the second plane to the uppermost point of the cardia exceeds 5 mm.

[0257] According to one embodiment, the steps of positioning and fixing the motion restriction device include positioning the center of mass of the motion restriction device on a second plane extending perpendicular to the craniococcygeal direction, wherein the shortest distance from a point on the second plane to the uppermost point of the cardia exceeds 10 mm.

[0258] According to one embodiment, the steps of positioning and securing the motion restriction device include positioning the motion restriction device to surround at least 1 / 2 of the esophagus in a plane extending perpendicular to the craniocaudal direction.

[0259] According to one embodiment, the steps of positioning and securing the motion restriction device include positioning the motion restriction device to surround at least 2 / 3 of the esophagus in a plane extending perpendicular to the craniocaudal direction.

[0260] According to one embodiment, the steps of positioning and securing the motion restriction device include positioning the motion restriction device around the esophagus in a plane extending perpendicular to the craniocaudate direction.

[0261] According to one embodiment, the radius of curvature of the curved inner surface configured to face the curved outer surface of the esophagus can correspond to or exceed the radius of curvature of the esophagus, such that the radius of curvature of the curved inner surface corresponds to or exceeds the radius of curvature of the esophagus.

[0262] According to one embodiment, the steps of positioning and securing a motion restriction device include positioning the motion restriction device, which includes an electrode arrangement configured to electrically stimulate the muscle tissue and / or serosa of a portion of the gastric fundus to improve the long-term implantation conditions of the motion restriction device.

[0263] According to one embodiment, the method further includes implanting an implantable energy source configured to provide power to the electrodes.

[0264] According to one embodiment, the steps of positioning and securing the motion restriction device include positioning the motion restriction device having a contracted state and an expanded state, the contracted state for preventing fluid from entering the esophagus from the stomach, and the expanded state for allowing food to enter the stomach in response to a patient's swallowing.

[0265] According to one embodiment, the step of positioning a motion restriction device includes positioning the motion restriction device, which is configured to apply circumferential pressure to the esophagus in a contracted state.

[0266] According to one embodiment, the step of positioning and securing a motion restriction device includes positioning the motion restriction device including at least one suction device for elastically attracting adjacent portions of the motion restriction device to generate circumferential pressure.

[0267] The attractor may include an elastic element or at least two magnets that attract each other. The device may further include a connector that links a first magnet and a second magnet among the at least two magnets to each other.

[0268] According to one embodiment, the step of positioning and securing the motion restriction device includes positioning and securing the motion restriction device having an adjustable volume.

[0269] A further objective is to reduce the risk of displacement of the implantable motion-limiting devices disclosed herein. Displacement of motion-limiting devices is generally undesirable because it may reduce the effectiveness of reflux disease treatment in human patients receiving such devices.

[0270] According to one aspect, a device for treating reflux disease in a human patient is provided. The device includes an implantable motion-limiting device configured to be at least partially enclosed by the patient's stomach wall to limit movement of the patient's cardia toward the diaphragm. The implantable motion-limiting device includes a surface-reducing coating covering at least a portion of its surface. The surface-reducing coating is configured to reduce friction between the implantable motion-limiting device and the stomach wall tissue that at least partially encloses it. It has been recognized that covering at least a portion of the surface of the implantable motion-limiting device with a surface-reducing coating can advantageously prevent or reduce the risk of displacement of the implantable motion-limiting device. During implantation, the surface-reducing coating maximally contacts the surrounding tissue and provides lubrication for the motion-limiting device.

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

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

[0273] In some embodiments, the surface anti-friction coating comprises one or more natural polymers dissolved in water. Preferred natural polymers are selected from polysaccharides, such as natural and modified cellulose, natural and modified starch, xanthan gum, guar gum, carrageenan, alginate, pectin, and combinations thereof. A preferred polymer is methylcellulose, such as hydroxypropyl methylcellulose (HPMC) and carboxymethyl cellulose. Another preferred polymer is ethylcellulose, such as hydroxyethyl cellulose.

[0274] An example of a usable hydrogel is poly(propylene fumarate) coethylene glycol hydrogel.

[0275] In some embodiments, the surface friction-reducing coating is selected from lacin oil, mineral oil, glycerin, and polyethylene glycol (PEG). PEG is a preferred agent. Larger PEG sizes (>5 kDa) are further preferred because they remain in the tissue for several days before being removed.

[0276] The surface friction-reducing coating may also contain active agents such as antibacterial agents, antibiotics, bacteriostatic agents, analgesics, and anesthetics.

[0277] Examples of bactericides and bacteriostatic agents that can be used in anti-friction coatings include antibiotics. Antibiotics are naturally occurring or synthetic substances used to kill bacteria or inhibit bacterial growth. Some 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 and doxycycline), quinolones (e.g., ciprofloxacin and levofloxacin), sulfonamides (e.g., sulfamethoxazole and trimethoprim), and aminoglycosides (e.g., gentamicin and tobramycin). Other examples of bactericides and bacteriostatic agents that can be used in anti-friction coatings include bacteriophages.

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

[0279] Examples of anesthetics that can be used in surface friction-reducing coatings include ester-based or amide-based local anesthetics. Examples of ester-based local anesthetics include procaine, tetracaine, cocaine, benzocaine, and tetracaine. Examples of amide-based local anesthetics include lidocaine, prilocaine, bupivacaine, levobupivacaine, ropivacaine, mepivacaine, dibutylcaine, and eticaine. A preferred anesthetic is lidocaine, preferably at a concentration of 1% to 10% (w / v), such as 1% to 5% (w / v), such as 1% to 3% (w / v), such as about 2% (w / v).

[0280] In some embodiments, the surface friction-reducing coating gives the motion-limiting device antibacterial properties.

[0281] Surface anti-friction coatings may also contain pH-adjusting compounds, including weak acids, weak bases, and buffers.

[0282] In some embodiments, the surface friction-reducing coating softens adjacent tissue. This can further prevent or reduce the risk of displacement of implantable motion-limiting devices.

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

[0284] Preferably, the viscous medium is a viscous aqueous medium, such as a viscous aqueous liquid or a viscous aqueous solution. The viscous aqueous medium can also be a viscoelastic medium. A preferred viscoelastic medium is a gel. The viscous medium can also be a viscous liquid.

[0285] For example, a shear rate controlled rheometer (Model 302, Anton Paar GmbH, Germany) can be used with a parallel plate geometry (50 mm diameter, 100 μm gap) to measure viscosity at 20°C. In this setup, the viscosity of water is approximately constant at a shear rate of 0 to 100 s⁻¹, around 1 mPa·s. For the avoidance of doubt, viscous media, as defined herein, have a much higher viscosity than water. At shear rates between 0 and 100 s⁻¹ (e.g., 50 s⁻¹), viscous media, as defined herein, typically exhibit a viscosity of at least 10 mPa·s, such as at least 50 mPa·s. Preferably, at shear rates between 0 and 100 s⁻¹ (e.g., 50 s⁻¹), viscous media, as defined herein, exhibit a viscosity of at least 100 mPa·s, such as at least 200 mPa·s. These specific values ​​are relevant to this particular setup, but those skilled in the art can readily determine the corresponding viscosity values ​​in other experimental settings. Typically, the viscosity of surface anti-friction coatings is higher than that of water.

[0286] The surface friction-reducing coating may contain preservatives. 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 in the bag for housing an implantable motion restriction device for more than 7 days, preferably more than 14 days, such as more than 21 or 28 days.

[0288] Specific examples of surface friction-reducing coatings are:

[0289] (1) Serocaine gel containing 0.1% to 10% (w / v) serocaine (lidocaine hydrochloride). The composition also contains methylparaben, propylparaben, hydroxypropyl methylcellulose, and sodium hydroxide and / or hydrochloric acid to adjust the pH to 6.0 to 7.0.

[0290] (2) A serocaine viscous composition containing 0.1% to 10% (w / v) serocaine (lidocaine hydrochloride). The composition also contains sodium carboxymethyl cellulose, methylparaben, propylparaben, purified water, and sodium saccharin.

[0291] (3) Surgical lubricant containing hydroxypropyl methylcellulose, propylene glycol, chlorhexidine gluconate and sterile water.

[0292] (4) Polypropylene fumarate coethylene glycol hydrogel

[0293] (5) Polyethylene glycol (PEG) polymer, >5kDa

[0294] (6) Lubricating glycerin gel containing water, PEG, glycerin, carbomer, sodium hydroxide, methylparaben, and propylparaben.

[0295] (7) Lidocaine gel containing 0.1% to 10% (w / v) lidocaine hydrochloride. The composition also contains glycerol, hydrochloric acid, hydroxyethyl cellulose, sodium hydroxide and water.

[0296] In some embodiments disclosed herein, the implantable motion restriction device is sized such that it can be completely contained within the patient's gastric fundus, as described herein. Preferably, the volume of the implantable motion restriction device is 0.3 cm. 3 Up to 6.6cm 3 Within the range, or within 0.5cm 3 Up to 7.3cm 3 Within a range, or within 3cm 3 Up to 8cm 3 Within the range, or within 2.5cm 3 Up to 6.6cm 3 Within the range, or within 4cm 3 Up to 7.3cm 3 Within the range.

[0297] In some embodiments disclosed herein, the motion limiting device is elongated. A first cross-sectional distance has a first length, and a second cross-sectional distance has a second length, wherein the first length is greater than 1.2 times the second length, preferably greater than 1.5 times the second length, and even more preferably greater than 2 times the second length.

[0298] In some embodiments disclosed herein, the implantable motion restriction device (100) includes at least one circular cross-section. In some embodiments, the implantable motion restriction device (100) includes a first cross-section, a second cross-section, and a third cross-section located on mutually spaced and parallel planes, wherein the first and third cross-sections have the same area, and the second cross-section is located between the first and third cross-sections and has a smaller area.

[0299] In some embodiments disclosed herein, the implantable motion restriction device includes at least two components, at least three components, or at least four components. Optionally, the at least two components are configured to assemble to form the implantable motion restriction device. Further optionally, the at least two components are configured to connect to each other to form the implantable motion restriction device.

[0300] In some embodiments disclosed herein, the motion restriction device includes a curved cross-section located in a plane parallel to the patient's cross-section, wherein the curved surface is configured to partially surround the patient's esophagus. Advantageously, the motion restriction device is configured to surround at least 1 / 3 of the esophagus in a plane parallel to the patient's cross-section, and preferably at least 1 / 2 of the esophagus in a plane parallel to the patient's cross-section. In some embodiments disclosed herein, the motion restriction device includes a C-shaped cross-section located in a plane parallel to the patient's cross-section, wherein the C-shaped cross-section is configured to partially surround the patient's esophagus. Optionally, the motion restriction device is configured to surround at least 2 / 3 of the esophagus in a plane parallel to the patient's cross-section. In a specific embodiment, the cross-section of the motion restriction device in a plane parallel to the patient's cross-section includes a closed curve configured to surround the patient's esophagus.

[0301] In some embodiments disclosed herein, the implantable motion restriction device (100) includes at least one circular cross section.

[0302] According to relevant sources, a method for treating reflux disease in a human patient by implanting a motion-limiting device (100) is also provided. The method includes: at least partially enclosing the motion-limiting device in the patient's stomach such that the device restricts the movement of the cardia (22) of the patient's stomach (10) toward the diaphragm (30) to prevent the cardia from sliding into the patient's thoracic cavity through the diaphragmatic hiatus (32), wherein the surface of the motion-limiting device is at least partially covered by a surface friction-reducing coating.

[0303] Furthermore, a friction-reducing composition is provided as a surface friction-reducing coating in the method defined herein.

[0304] Also provided is the use of a composition as a surface friction-reducing coating on at least a portion of the surface of an implantable motion-limiting device for the treatment of reflux disease in human patients, the composition being selected from natural polymers, polysaccharide coatings, oils, hydrogels and lubricating gels, wherein the motion-limiting device (100) is configured to be at least partially enclosed by the patient's stomach wall and arranged to restrict the movement of the cardia (22) of the patient's stomach (10) toward the diaphragm (30) to prevent the cardia from sliding into the patient's thoracic cavity through the diaphragmatic hiatus (32).

[0305] During implantation, the surface friction-reducing coating makes maximum contact with the surrounding tissue and provides lubrication for the motion-limiting device.

[0306] In some embodiments, the method includes the step of applying a surface-reducing coating to the motion-limiting device prior to implantation into the patient's body. This means the coating is applied externally. In other embodiments, the method includes the step of applying the surface-reducing coating in situ between the motion-limiting device and the patient's gastric wall tissue.

[0307] In some embodiments, the method includes the following steps:

[0308] - The movement restriction device is partially inserted into the patient's stomach.

[0309] - Apply a surface friction-reducing coating in situ between the motion restriction device and the patient's gastric wall tissue, and

[0310] - Further, the movement restriction device is placed inside the patient's stomach.

[0311] Optionally, the step of at least partially enclosing the motion restriction device in the patient's stomach includes completely enclosing the motion restriction device in the patient's stomach.

[0312] In some embodiments, the method is a laparoscopic surgical method, and the method further includes the step of introducing a motion-limiting device into the patient's body through a laparoscopic cannula after applying a surface friction-reducing coating.

[0313] In other embodiments, the method is a laparoscopic surgical method, and the step of applying a surface friction-reducing coating in situ between the motion-limiting device and the patient's gastric wall tissue includes applying the surface friction-reducing coating in situ using a laparoscopic instrument inserted into the patient's body through a laparoscopic cannula.

[0314] In some embodiments, the method is an endoscopic method, and the method further includes the step of introducing a motion-limiting device into the patient's body through the patient's esophagus after applying a surface friction-reducing coating.

[0315] In some embodiments, the method is an endoscopic method, and the step of applying a surface friction-reducing coating in situ between the motion-limiting device and the patient's gastric wall tissue includes applying the surface friction-reducing coating in situ using an endoscopic instrument inserted through the esophagus into the patient's body.

[0316] Typically, the surface friction-reducing coating covers at least 20%, such as at least 30%, such as at least 40%, such as at least 50%, such as at least 60%, such as at least 70%, such as at least 80%, such as at least 90%, such as at least 95%, of the surface of the motion restriction device. According to one embodiment, the surface friction-reducing coating covers the entire surface of the motion restriction device. Higher surface coverage is associated with a greater reduction in the risk of displacement of the implantable motion restriction device.

[0317] In some embodiments, the step of at least partially enclosing the motion limiting device includes at least partially enclosing the motion limiting device including a surface friction-reducing coating that covers the entire surface of the motion limiting device.

[0318] In a preferred embodiment, the step of at least partially enclosing the motion limiting device includes at least partially enclosing the motion limiting device including a surface friction-reducing coating selected from natural polymers, polysaccharide coatings, oils, hydrogels, and lubricating gels.

[0319] In some embodiments, the surface anti-friction coating comprises one or more natural polymers dissolved in water. Preferred natural polymers are selected from polysaccharides, such as natural and modified cellulose, natural and modified starch, xanthan gum, guar gum, carrageenan, alginate, pectin, and combinations thereof. A preferred polymer is methylcellulose, such as hydroxypropyl methylcellulose (HPMC) and carboxymethyl cellulose. Another preferred polymer is ethylcellulose, such as hydroxyethyl cellulose.

[0320] An example of a usable hydrogel is poly(propylene fumarate) coethylene glycol hydrogel.

[0321] In some embodiments, the surface friction-reducing coating is selected from lacin oil, mineral oil, glycerin, and polyethylene glycol (PEG). PEG is a preferred agent. Larger PEG sizes (>5 kDa) are further preferred because they remain in the tissue for several days before being removed.

[0322] The surface friction-reducing coating may also contain active agents such as antibacterial agents, antibiotics, bacteriostatic agents, analgesics, and anesthetics.

[0323] Examples of bactericides and bacteriostatic agents that can be used in anti-friction coatings include antibiotics. Antibiotics are naturally occurring or synthetic substances used to kill bacteria or inhibit bacterial growth. Some 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 and doxycycline), quinolones (e.g., ciprofloxacin and levofloxacin), sulfonamides (e.g., sulfamethoxazole and trimethoprim), and aminoglycosides (e.g., gentamicin and tobramycin). Other examples of bactericides and bacteriostatic agents that can be used in anti-friction coatings include bacteriophages.

[0324] Examples of analgesics that can be used in surface friction-reducing coatings include anti-inflammatory analgesics (such as acetaminophen, aspirin, COX inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen) and opioids (such as codeine, fentanyl, hydrocodone, meperidine, methadone, naloxone, naltrexone, and hydroxycodone).

[0325] Examples of anesthetics that can be used in surface friction-reducing coatings include ester-based or amide-based local anesthetics. Examples of ester-based local anesthetics include procaine, tetracaine, cocaine, benzocaine, and tetracaine. Examples of amide-based local anesthetics include lidocaine, prilocaine, bupivacaine, levobupivacaine, ropivacaine, mepivacaine, dibutylcaine, and eticaine. A preferred anesthetic is lidocaine, preferably at a concentration of 1% to 10% (w / v), such as 1% to 5% (w / v), such as 1% to 3% (w / v), such as about 2% (w / v).

[0326] In some embodiments, the surface friction-reducing coating gives the motion-limiting device antibacterial properties.

[0327] Surface anti-friction coatings may also contain pH-adjusting compounds, including weak acids, weak bases, and buffers.

[0328] In some embodiments, the surface friction-reducing coating softens adjacent tissue. This can further prevent or reduce the risk of displacement of implantable motion-limiting devices.

[0329] In some embodiments, the surface friction-reducing coating is a viscous medium. A viscous coating composition is a liquid or semi-solid material used to form a protective layer or film on a surface. Such a coating is characterized by its thickness and viscosity, allowing it to adhere to the surface and form a durable, long-lasting layer. There are many different types of viscous coating compositions, each with its own unique properties and characteristics.

[0330] Preferably, the viscous medium is a viscous aqueous medium, such as a viscous aqueous liquid or a viscous aqueous solution. The viscous aqueous medium can also be a viscoelastic medium. A preferred viscoelastic medium is a gel. The viscous medium can also be a viscous liquid.

[0331] For example, a shear rate controlled rheometer (Model 302, Anton Paar GmbH, Germany) can be used with a parallel plate geometry (50 mm diameter, 100 μm gap) to measure viscosity at 20°C. In this setup, the viscosity of water is approximately constant at a shear rate of 0 to 100 s⁻¹, around 1 mPa·s. For the avoidance of doubt, viscous media, as defined herein, have a much higher viscosity than water. At shear rates between 0 and 100 s⁻¹ (e.g., 50 s⁻¹), viscous media, as defined herein, typically exhibit a viscosity of at least 10 mPa·s, such as at least 50 mPa·s. Preferably, at shear rates between 0 and 100 s⁻¹ (e.g., 50 s⁻¹), viscous media, as defined herein, exhibit a viscosity of at least 100 mPa·s, such as at least 200 mPa·s. These specific values ​​are relevant to this particular setup, but those skilled in the art can readily determine the corresponding viscosity values ​​in other experimental settings. Typically, the viscosity of surface anti-friction coatings is higher than that of water.

[0332] The surface friction-reducing coating may contain preservatives. 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.

[0333] Preferably, the surface friction-reducing coating is configured to remain in the bag for housing an implantable motion restriction device for more than 7 days, preferably more than 14 days, such as more than 21 or 28 days.

[0334] Specific examples of surface friction-reducing coatings are:

[0335] (1) Serocaine gel containing 0.1% to 10% (w / v) serocaine (lidocaine hydrochloride). The composition also contains methylparaben, propylparaben, hydroxypropyl methylcellulose, and sodium hydroxide and / or hydrochloric acid to adjust the pH to 6.0 to 7.0.

[0336] (2) A serocaine viscous composition containing 0.1% to 10% (w / v) serocaine (lidocaine hydrochloride). The composition also contains sodium carboxymethyl cellulose, methylparaben, propylparaben, purified water, and sodium saccharin.

[0337] (3) Surgical lubricant containing hydroxypropyl methylcellulose, propylene glycol, chlorhexidine gluconate and sterile water.

[0338] (4) Polypropylene fumarate coethylene glycol hydrogel

[0339] (5) Polyethylene glycol (PEG) polymer, >5kDa

[0340] (6) Lubricating glycerin gel containing water, PEG, glycerin, carbomer, sodium hydroxide, methylparaben, and propylparaben.

[0341] (7) Lidocaine gel containing 0.1% to 10% (w / v) lidocaine hydrochloride. The composition also contains glycerol, hydrochloric acid, hydroxyethyl cellulose, sodium hydroxide and water.

[0342] In some embodiments disclosed herein, the implantable motion restriction device is sized such that it can be completely contained within the patient's gastric fundus, as described herein. Preferably, the volume of the implantable motion restriction device is 0.3 cm. 3 Up to 6.6cm 3 Within the range, or within 0.5cm 3 Up to 7.3cm 3 Within a range, or within 3cm 3 Up to 8cm 3Within the range, or within 2.5cm 3 Up to 6.6cm 3 Within the range, or within 4cm 3 Up to 7.3cm 3 Within the range.

[0343] The step of at least partially enclosing a motion-restricting device may include at least partially enclosing a motion-restricting device of a size such that the implantable motion-restricting device can be completely enclosed by the patient's gastric fundus. Preferably, the step of at least partially enclosing a motion-restricting device includes at least partially enclosing a motion-restricting device of a volume of less than 0.3 cm². 3 Up to 6.6cm 3 Within the range, or within 0.5cm 3 Up to 7.3cm 3 Within a range, or within 3cm 3 Up to 8cm 3 Within the range, or within 2.5cm 3 Up to 6.6cm 3 Within the range, or within 4cm 3 Up to 7.3cm 3 Within the range.

[0344] In some embodiments, the step of at least partially enclosing the motion restriction device includes at least partially enclosing the elongated motion restriction device having 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, wherein the first length is greater than 1.2 times the second length, preferably greater than 1.5 times the second length, and even more preferably greater than 2 times the second length.

[0345] In some embodiments, the step of at least partially enclosing the motion limiting device includes at least partially enclosing the motion limiting device, which includes at least one circular cross-section.

[0346] In some embodiments, the step of at least partially enclosing the motion restriction device includes at least partially enclosing the motion restriction device comprising a first cross-section, a second cross-section, and a third cross-section located on mutually spaced and parallel planes, wherein the first cross-section and the third cross-section have the same area, and the second cross-section is located between the first cross-section and the third cross-section and has a smaller area.

[0347] In some embodiments, the step of at least partially enclosing the motion restriction device includes at least partially enclosing the motion restriction device, which comprises at least two components, at least three components, or at least four components. Preferably, the step of at least partially enclosing the motion restriction device includes assembling at least two components for forming an implantable motion restriction device.

[0348] In some embodiments, the step of at least partially enclosing a motion restriction device includes at least partially enclosing a motion restriction device comprising a curved cross-section located on a plane parallel to the patient's cross-section, wherein the curved surface is configured to partially surround the patient's esophagus.

[0349] In some embodiments, the step of at least partially enclosing the motion limiting device includes at least partially enclosing the motion limiting device, which includes at least one circular cross-section.

[0350] According to one aspect, a device for treating reflux disease in human patients is provided, the device comprising an implantable motility limiting device and an electrode arrangement. The shape and size of the implantable motility limiting device allow it to be positioned against and at least partially enclosed by a portion of the fundus wall of the patient's stomach, such that the motility limiting device is implanted between the patient's diaphragm and the lower portion of the fundus wall, and restricts the movement of the patient's cardia toward the diaphragm to prevent the cardia from slipping into the patient's thoracic cavity through the diaphragmatic hiatus. The electrode arrangement is configured to be positioned between the motility limiting device and the fundus wall portion, and engages with and electrically stimulates the muscle tissue of the fundus wall portion to exercise the muscle tissue and improve long-term implantation conditions of the motility limiting device.

[0351] According to one aspect, a device for treating reflux disease in a human patient is provided, the device comprising an implantable motion restriction device at least partially annular in shape and an electrode arrangement. The implantable motion restriction device includes a first portion configured to be at least partially enclosed by a first gastric wall portion of the patient's stomach, and arranged such that at least a portion of the first portion is positioned above the cardia notch of the patient's stomach, thereby restricting movement of the cardia toward the diaphragm to prevent the cardia from slipping into the patient's thoracic cavity through the diaphragmatic hiatus. The electrode arrangement is configured to be positioned between the motion restriction device and the first gastric wall portion, and electrically stimulates the muscle tissue of the first gastric wall portion to exercise the muscle tissue and improve long-term implantation conditions of the motion restriction device.

[0352] According to one aspect, a device for treating reflux disease in a human patient is provided, the device comprising an elongated core and a tubular cover. The length of the elongated core allows the core to at least partially surround the patient's esophagus, wherein the length is variable to allow the core to be arranged in a contracted state to prevent fluid from entering the esophagus from the stomach and in an expanded state to allow food to enter the stomach in response to the patient's swallowing. The tubular cover is configured to surround at least a portion of the core and includes a plurality of portions adapted to bend relative to each other, allowing the core to change between a contracted and expanded state when the cover is at least partially covered by fibrotic tissue, substantially without being blocked or obstructed by the presence of said fibrotic tissue.

[0353] According to one aspect, a device for treating reflux disease in a human patient is provided. The device includes an elongated core of a length that allows the core to at least partially encircle the patient's esophagus, wherein the length is variable to allow the core to be arranged in a contracted state to prevent fluid from entering the esophagus from the stomach and in a dilated state to allow food to enter the stomach in response to the patient's swallowing. The device further includes an electrode arrangement comprising electrode elements supported by the core and configured to be disposed between the device and the esophagus to electrically stimulate the muscular tissue of the esophagus.

[0354] According to one aspect, an apparatus for treating reflux disease in a human patient is provided, the apparatus comprising a tubular device of a length that allows the tubular device to at least partially encircle the patient's esophagus, wherein the length is variable to allow the tubular covering to be arranged in a contracted state to prevent fluid from entering the esophagus from the stomach and in an expanded state to allow food to enter the stomach in response to the patient's swallowing. The outer surface of the tubular device may include a plurality of portions adapted to bend relative to each other and, when the outer surface is at least partially covered by fibrotic tissue, allow the tubular device to change between a contracted and expanded state substantially unimpeded or obstructed by the presence of said fibrotic tissue.

[0355] According to one aspect, a device for treating reflux disease in a human patient is provided, the device comprising an elongated core, the length of which allows the core to at least partially surround the patient's esophagus. This length can be variable to allow the core to be arranged in a contracted state to prevent fluid from entering the esophagus from the stomach and in an expanded state to allow food to enter the stomach in response to the patient's swallowing. Additionally, the size of the elongated core allows at least a portion of the elongated core to protrude above the patient's lower esophageal sphincter upon implantation, thereby restricting the movement of the lower esophageal sphincter toward the diaphragm to prevent the lower esophageal sphincter from slipping into the patient's thoracic cavity through the diaphragmatic hiatus.

[0356] According to one aspect, a device for treating reflux disease in a human patient is provided, the device being adapted to at least partially surround the patient's esophagus (20). The device includes a first implantable portion and a second implantable portion, wherein the shape and size of the first implantable portion allow it to be arranged against and at least partially enclosed by a portion of the fundus wall of the patient's stomach, such that the first implantable portion is positioned between the patient's diaphragm and the lower portion of the fundus wall, and such that movement of the patient's cardia toward the diaphragm is restricted to prevent the cardia from sliding into the patient's thoracic cavity through the diaphragmatic hiatus. The second implantable portion is elongated to at least partially surround the esophagus and has a variable length allowing the device to be arranged in a contracted state to prevent fluid from entering the esophagus from the stomach and in an expanded state to allow food to enter the stomach in response to the patient's swallowing.

[0357] According to one aspect, a device for treating reflux disease in a human patient is provided, the device being adapted to at least partially surround the patient's esophagus. The device includes a motility restricting device, an elongated support device, and an electrode arrangement. The shape and size of the motility restricting device allow it to be arranged against and at least partially enclosed by a portion of the fundus wall of the patient's stomach, such that a first implantable portion is positioned between the patient's diaphragm and the lower portion of the fundus wall, and such that movement of the patient's cardia toward the diaphragm is restricted to prevent the cardia from sliding into the patient's thoracic cavity through the diaphragmatic hiatus. The elongated support device is connected to the motility restricting device and is configured to at least partially surround the esophagus. The electrode arrangement includes electrode elements supported by the support device and configured to electrically stimulate the muscular tissue of the esophagus. Additionally, the support device has a degree of rigidity, allowing the position of the electrode elements relative to the esophagus to be determined primarily by the position and orientation of the motility restricting device.

[0358] According to one aspect, a method for treating reflux disease in a human patient is provided. The method includes implanting a motility-restricting device such that the device is arranged to restrict movement of the cardia of the patient's stomach toward the diaphragm to prevent the cardia from slipping into the patient's thoracic cavity through the diaphragmatic hiatus. The method includes positioning the motility-restricting device such that a lower portion of the device rests against the serosa at the His angle, and an upper portion of the device rests against the His angle, defining a gap between the motility-restricting device and the patient's esophagus. The method further includes disposing a portion of the fundus of the stomach within the gap and attaching the fundus to the patient's esophagus such that the motility-restricting device is at least partially surrounded by this portion of the fundus.

[0359] According to one aspect, a device for treating reflux disease in a human patient is provided, the device comprising an implantable motility limiting device and an elongated attachable device configured to attach to the motility limiting device and at least partially enclosed by a portion of the stomach wall of the patient's stomach. The shape and size of the attachable device allow it to be enclosed by the stomach wall portion to prevent rotation of the motility limiting device. The attachable device is also configured to be enclosed by the stomach wall portion such that the motility limiting device is positioned away from the patient's esophagus between the patient's diaphragm and the portion of the stomach wall to restrict movement of the patient's gastric cardia toward the diaphragm to prevent the cardia from slipping into the patient's thoracic cavity through the diaphragmatic hiatus.

[0360] According to one aspect, an elongated attachable device is configured to attach to a motion-limiting device and perform at least one of the following operations: partially encased in a portion of the patient's stomach wall and sutured to a previously sutured row of anastomoses in a surgically modified stomach. The shape and size of the attachable device allow it to be encased or sutured to the anastomose-reinforced portion of the stomach wall to hold the device in place and prevent rotation of the motion-limiting device. The attachable device is configured to be sutured to or encased in a portion of the stomach wall so that the motion-limiting device is positioned between the patient's diaphragm and the portion of the stomach wall, close to but not in contact with the patient's esophagus, above the LES, to restrict movement of the patient's stomach's cardia toward the diaphragm while simultaneously preventing the cardia from slipping into the patient's thoracic cavity through the diaphragmatic hiatus.

[0361] According to one aspect, a device for treating reflux disease in a human patient includes an implantable motility limiting device and an elongated attachable device configured to attach to the motility limiting device and perform at least one of the following operations: being partially enclosed by a portion of the patient's stomach wall and sutured to a previously sutured row of anastomoses in a surgically modified stomach. The shape and size of the attachable device allow it to be enclosed or sutured to the anastomose-reinforced portion of the stomach wall to hold the device in place and prevent rotation of the motility limiting device. The attachable device is configured to be sutured to or enclosed by a portion of the stomach wall such that the motility limiting device is positioned between the patient's diaphragm and the portion of the stomach wall, close to but not in contact with the patient's esophagus, and above the LES, to restrict movement of the patient's stomach's cardia toward the diaphragm while simultaneously preventing the cardia from slipping into the patient's thoracic cavity through the diaphragmatic hiatus.

[0362] According to one aspect, a device for treating reflux disease in a human patient includes an implantable motion-limiting device that is at least partially annular. The implantable motion-limiting device is configured such that a first lower portion of the device is positioned at the cardia of the patient's stomach, and a second upper portion of the device is positioned against the patient's diaphragm, thereby restricting movement of the cardia toward the diaphragm to prevent the cardia from slipping into the patient's thoracic cavity through the diaphragmatic hiatus. The device is further configured to define a gap or septum between the second upper portion of the motion-limiting device and the lateral aspect of the esophagus when the device is implanted. The device may be formed of, or at least include, a motion-limiting device as disclosed herein.

[0363] According to one aspect, a method for treating reflux disease in a human patient is provided, the method comprising: implanting a device including a motility limiting device and an elongated support device, such that the support device at least partially surrounds the patient's esophagus, and such that the motility limiting device is positioned on the fundus side of the esophagus to restrict movement of the cardia relative to the diaphragm to prevent the cardia from slipping into the patient's thoracic cavity through the diaphragmatic hiatus. The method includes the steps of: introducing the device into the abdominal cavity; positioning the device such that the motility limiting device rests against the fundus of the stomach; wrapping a portion of the fundus around at least a portion of the motility limiting device; attaching the fundus to the esophagus such that the motility limiting device is positioned between the diaphragm and the cardia sphincter, and such that a portion of the fundus is positioned between the motility limiting device and the esophagus; and arranging the support device at least partially surrounds the esophagus. The motility limiting device and the second portion form an annular body that extends through a pouch to at least partially surround the esophagus.

[0364] According to one aspect, a method is provided for attaching a portion of the gastric fundus of a human patient to the patient's esophagus, wherein the gastric fundus extends from the His angle in a direction away from the esophagus. The method includes: folding the gastric fundus toward the esophagus such that the gastric fundus rests against the esophagus upwards from the His angle along the esophagus, and attaching the gastric fundus to the esophagus by fasteners arranged along a first line and a second line. The first line and the second line extend along the esophagus and are arranged such that the distance between the first line and the second line increases with increasing distance from the His angle.

[0365] According to one aspect, an apparatus for treating reflux disease in a human patient is provided according to any one of the foregoing aspects. The apparatus includes an electrode arrangement, as described above, for electrically stimulating the patient's muscle tissue to exercise the muscle tissue and improve long-term implantation conditions of the apparatus. The apparatus further includes an implantable energy source and a controller configured to provide power to the electrode arrangement, the controller being operatively connected to the electrode arrangement for controlling the electrical stimulation of the muscle tissue.

[0366] According to one aspect, an apparatus for treating reflux disease in a human patient is provided according to any one of the preceding aspects. The apparatus includes: an electrode arrangement; an implantable energy source configured to provide power to the apparatus; an external energy source configured to be disposed outside the patient's body and configured to provide energy to the implantable energy source; and an implantable charger configured to be electrically connected to the implantable energy source and capable of charging the implantable energy source via the external energy source.

[0367] According to one aspect, an apparatus for treating reflux disease in a human patient is provided, the apparatus comprising: an implantable motion-limiting device of a shape and size that allows it to be arranged to rest against a portion of the gastric fundus wall of a patient’s stomach (10), such that the motion-limiting device is implanted between the patient’s diaphragm (30) and a portion of the gastric fundus wall, and such that movement of the patient’s cardia (22) toward the diaphragm is restricted to prevent the cardia from sliding into the patient’s thoracic cavity through the diaphragmatic hiatus, wherein an outer surface of the implantable motion-limiting device is configured to rest against a portion of the gastric wall, wherein an average surface roughness measured on the outer surface does not exceed 300,000 μm.

[0368] According to one aspect, an apparatus for treating reflux disease in a human patient is provided, the apparatus comprising: an implantable motion-limiting device shaped and sized to allow it to be arranged against a portion of the gastric fundus wall of a patient's stomach, such that the motion-limiting device is implanted between the patient's diaphragm and a portion of the gastric fundus wall, and such that movement of the patient's gastric cardia toward the diaphragm is restricted to prevent the cardia from slipping into the patient's thoracic cavity through the diaphragmatic hiatus, wherein an outer surface of the implantable motion-limiting device is configured to rest against an outer surface of the gastric wall portion, wherein a Shore A indentation hardness measured on the outer surface is at least 50, or in the range of 50 to 65, or in the range of 5 to 25, or in the range of >25 to 50, or >65.

[0369] According to one aspect, a device for treating reflux disease in a human patient is provided, the device comprising an implantable motion-limiting device of a shape and size that allows it to be arranged against a portion of the gastric fundus wall of a patient's stomach, such that the motion-limiting device is implanted between the patient's diaphragm and a portion of the gastric fundus wall, and such that movement of the patient's cardia toward the diaphragm is restricted to prevent the cardia from slipping into the patient's thoracic cavity through the diaphragmatic hiatus, wherein the implantable motion-limiting device comprises multiple segments, wherein the multiple segments consist of a core component and multiple external components, and wherein the average density of the core component is greater than 1000 kg / m3.

[0370] According to one embodiment, an apparatus for treating reflux disease in a human patient is provided according to any of the foregoing aspects. The apparatus includes an electrode arrangement and a controller configured to be operatively connected to the electrode arrangement for controlling electrical stimulation of muscle tissue. The controller includes an implantable communicator for transmitting signals to and / or receiving signals from outside the patient's body.

[0371] According to one embodiment of the above aspects, the electrode arrangement can be arranged on the outer surface of the motion restriction device.

[0372] According to some embodiments of the above aspects, the electrode arrangement may include a plurality of electrode elements, wherein each electrode element is configured to engage and electrically stimulate muscle tissue. The electrode arrangement may further include coiled wires for increasing the contact surface between the electrode arrangement and the muscle tissue and allowing the electrode arrangement to follow the contraction and relaxation of the muscle tissue.

[0373] According to some embodiments of the above aspects, the electrode arrangement may include exposed electrode portions configured to form a metal-tissue interface with muscle tissue, thereby allowing Faraday charge transfer to become the dominant charge transfer mechanism at the interface. Alternatively or otherwise, the electrode arrangement may include electrode portions at least partially covered by a dielectric material configured to form a dielectric-tissue interface with muscle tissue, thereby allowing a reduction in the Faraday portion of the charge transfer mechanism at the interface.

[0374] According to some embodiments, the electrode arrangement can be configured to electrically stimulate the lower esophageal sphincter to induce contraction of the lower esophageal sphincter. The electrode arrangement may include at least two electrode elements configured to be positioned on opposite sides of the lower esophageal sphincter. Additionally, the device may include a retainer configured to support at least two electrode elements on opposite sides of the lower esophageal sphincter.

[0375] Exemplary embodiments of the motion restriction device according to at least some of the foregoing aspects will now be discussed.

[0376] According to one embodiment, the volume of the motion restriction device may be non-adjustable after implantation. According to another embodiment, the volume of the motion restriction device may be adjustable after implantation. The volume can be adjusted in an invasive or non-invasive manner. The motion restriction device includes an injection port for allowing fluid to be injected into or extracted from the interior of the motion restriction device to change the volume of the motion restriction device after implantation.

[0377] In one example, a movement restriction device may include a biocompatible outer surface configured to rest against a portion of the gastric fundus wall.

[0378] In one example, the motion restriction device may be substantially spherical or egg-shaped. In another example, the motion restriction device may have a portion configured to point away from the esophagus when implanted. In a further example, the lower portion of the motion restriction device may be wider than the upper portion.

[0379] According to one embodiment, the motion-restricting device can be configured to be wrapped around the outer side of the gastric fundus portion. In another embodiment, the motion-restricting device can be configured to be wrapped around the inner side of the gastric fundus portion.

[0380] According to one embodiment, the motion-limiting device can be configured to be introduced into a patient's body via an endoscope or endoscopic instrument. For example, the motion-limiting device can be configured to change its shape during insertion into the patient's body to allow it to pass through a cannula.

[0381] According to one embodiment, the motion restriction device may be formed from at least two different and separable components, which are configured to be assembled into a motion restriction device after being inserted into the patient's body.

[0382] According to one embodiment, the minimum width of the motion restriction device measured from one side to the other may be 20 mm or greater, such as 30 mm or greater, such as 40 mm or greater, such as 50 mm or greater.

[0383] According to some embodiments, the motility restricting device may include a first portion and a second portion, wherein the first portion and the second portion are configured to be disposed on opposite sides of the cardia. In one example, the motility restricting device may be configured to form a gap between the second portion of the motility restricting device and the esophagus. In one example, the second portion of the motility restricting device may be configured to be at least partially enclosed by a second portion of the stomach wall.

[0384] According to one embodiment, the motion restriction device can be configured such that a portion of a first gastric wall portion is disposed between a first portion of the motion restriction device and the esophagus.

[0385] According to one embodiment, the motion restriction device can be configured to be at least partially enclosed by a first stomach wall portion along at least half of the circumferential length of the motion restriction device.

[0386] According to one embodiment, the motion restriction device can be configured to be enclosed when placed on the outside of the stomach wall.

[0387] According to one embodiment, the motion limiting device may include two end portions configured to connect with each other to form a closed loop. The end portions may be configured to be releasably attached to each other.

[0388] According to one embodiment, the polar perimeter of the first portion of the motion-limiting device may be greater than the polar perimeter of the second portion. In one example, the minimum width of the first portion of the motion-limiting device, measured from one side to the other, is 20 mm or greater, such as 30 mm or greater, such as 40 mm or greater, such as 50 mm or greater. Alternatively, the width may be defined as the height measured along the normal to the plane containing the circumference extension.

[0389] According to one embodiment, the motion limiting device may be shaped to a torus.

[0390] According to one embodiment, the motion restriction device may have a C-shaped cross-section.

[0391] According to one embodiment, the upper portion of the motion restriction device may include a recess defined on the outer surface of the motion restriction device.

[0392] According to one embodiment, the lower portion of the motion-limiting device may include a curved outer surface arranged to face the esophagus. The radius of curvature of the curved outer surface may correspond to or exceed the radius of curvature of the esophagus.

[0393] According to one embodiment, an elongated support protruding from the motion-limiting device can be at least partially contained within the fundus of the stomach before the fundus is attached to the esophagus. The support can be oriented along the esophagus.

[0394] Exemplary embodiments of the core and cover according to at least some of the foregoing aspects will now be discussed.

[0395] According to one embodiment, the core can be configured to allow a transition from a contracted state to an expanded state due to food passing through the esophagus. The core can be configured to apply circumferential pressure to the esophagus in the contracted state.

[0396] According to one embodiment, the device may further include an attractor for elastically attracting adjacent portions of the core to generate circumferential pressure. The attractor may include an elastic element and / or at least two mutually attracting magnets. Additionally, the device may include a connector connecting a first magnet and a second magnet of the at least two magnets to each other. The connector may be configured to extend into at least one of the magnets in response to movement of the magnets toward each other.

[0397] According to some embodiments, the core may include two end portions configured to connect with each other to form a closed loop around the esophagus. The end portions may be configured to be releasably attached to each other and may include corresponding interlocking attachers.

[0398] According to one embodiment, the core may include a plurality of core elements configured to be arranged in a circular array around the esophagus. The core may also include a plurality of connectors, wherein each connector may extend between a corresponding pair of core elements arranged adjacent to each other. The connectors may be configured to allow the corresponding core elements to move toward and away from each other, and may be configured to extend into at least one of the corresponding pair of core elements when the core elements move toward each other.

[0399] According to one embodiment, the cover may include a set of tubular segments.

[0400] According to one embodiment, the cover includes a biocompatible outer surface for long-term implantation. For example, the cover may be configured to rest against an outer surface of the esophagus and may further include a surface for promoting tissue growth. For example, the cover may be formed of a polymeric material such as silicone. In a further example, the cover may be formed of or include a carbon-based material such as carbon fiber.

[0401] According to some embodiments, the cover can be formed of a material with a thickness of 0.1 to 10 mm, such as 1 to 5 mm. The cover may include at least one predetermined fold, allowing the cover to fold along the at least one predetermined fold in response to a change in the length of the core. In some examples, the cover may include a lowering portion and a raising portion, thereby allowing the cover to change its length while maintaining its surface area. Thus, the cover can be configured to be compressible and expandable along its length, wherein the change in length is primarily due to the folding of the cover rather than to the elastic properties of the material. Therefore, the cover can be considered to be formed of a non-elastic material. In some examples, when at least a portion of the core is arranged in a contracted state, the length of the cover surrounding that at least a portion of the core may exceed the length of that at least a portion of the core.

[0402] An exemplary embodiment of the attachment, having a shape and size that allows it to be partially enclosed by the stomach wall as described above in conjunction with some aspects, in order to prevent the motion-limiting device from rotating.

[0403] According to some embodiments, a first end portion of the attachor may be configured to be enclosed by a portion of the stomach wall, and a second end portion may be configured to be attached to a motion-limiting device. The first and second portions may extend in different directions relative to each other, wherein the first portion may be configured to be enclosed by a portion of the stomach wall to prevent rotation of the motion-limiting device about a first axis, and wherein the second portion may be configured to be enclosed by a portion of the stomach wall to prevent rotation of the motion-limiting device about a second axis different from the first axis. The first and second portions of the attachor may be curved to follow the curvature of the stomach wall portion. The first and second portions may be arranged at an angle to each other, the angle being in the range of 60 to 120 degrees, such as 90 degrees.

[0404] According to some embodiments, the attach device can be configured to be releasably attached to a motion-limiting device. The attach device can be configured to allow adjustment of the position of the motion-limiting device after the attach device is incorporated. In some examples, the device can be configured to allow changes in the distance between the motion-limiting device and the attach device to allow adjustment of the position of the motion-limiting device relative to the diaphragm. Additionally, the device can be configured to allow changes in the orientation of the motion-limiting device relative to the attach device to allow adjustment of the position of the motion-limiting device relative to the diaphragm.

[0405] In one embodiment, the attachor may include a third portion configured to protrude from a portion of the stomach wall upon implantation and define the distance between the stomach wall portion and the motion-limiting device. The third portion may have curvature, allowing it to be arranged to point away from the esophagus upon implantation.

[0406] According to one embodiment, the motion restriction device and the attachment can be integrally formed as a single piece.

[0407] According to one embodiment, the motion-limiting device and the attachment device may each include a biocompatible outer surface. The attachment may include an outer surface configured to promote tissue growth. In some examples, the attachment may be formed of metal. In further examples, the motion-limiting device may be formed of a polymer.

[0408] According to one embodiment, the outer surface of the motion restriction device may include a material for preventing the growth of fibrotic tissue.

[0409] Exemplary embodiments of methods for treating reflux disease in human patients by implanting a device, including a motion-limiting device and a slender support device, as described above in conjunction with some aspects, will now be discussed below.

[0410] According to one embodiment, the device can be positioned such that the motion restriction device rests against the outer side of the fundus of the stomach, between the lower esophageal sphincter and the portion of the fundus of the stomach to be attached to the esophagus.

[0411] According to one embodiment, the device can be positioned such that the portion of the gastric fundus attached to the esophagus is positioned between the lower esophageal sphincter and the motion restriction device.

[0412] According to one embodiment, the pouch may be formed to be open in at least two locations to create a channel through which the device extends.

[0413] According to one embodiment, this portion of the gastric fundus can be attached to the patient's diaphragm.

[0414] According to one embodiment, attaching this portion of the gastric fundus to the esophagus may include suturing or anastomosis.

[0415] According to one embodiment, the support device may include a first end portion and a second end portion, and the esophagus may be introduced between the first end portion and the second end portion. The first end portion and the second end portion may be connected to each other to secure the support device to the esophagus in a circumferential manner.

[0416] According to one embodiment, the method may further include: inserting a needle or tubular instrument into the patient's abdomen, inflating the abdomen with gas using the needle or tubular instrument, placing at least two laparoscopic cannulas in the abdomen, inserting a camera through one of the laparoscopic cannulas into the abdomen, inserting at least one dissecting tool through one of the laparoscopic cannulas, dissecting a portion of the stomach, and at least partially closing the sac with sutures (such as barbed sutures) or staples.

[0417] In the following, exemplary embodiments of a method for attaching the fundus portion of a human patient to the esophagus according to the above aspects will now be described.

[0418] According to one embodiment, the abdominal portion of the esophagus and the fundus of the stomach are divided into a ventral and a dorsal side by a plane. The method may include: establishing a first line on the dorsal side of the plane and a second line on the ventral side of the plane. The first line may begin less than 1 cm above the His angle, and the second line may begin less than 3 cm above the His angle. In some examples, the second line may begin less than 2 cm from the first line.

[0419] According to one embodiment, the separation angle between the first line and the second line can be in the range of 90 to 150 degrees.

[0420] According to some embodiments, the method may include: providing an additional fastener at the top of the gastric fundus portion, between the first line and the second line.

[0421] In some examples, the fastener may include a staple. In some examples, the fastener may include sutures, such as barbed sutures. For example, the fastener for the first suture may include a first continuous suture, and the fastener for the second suture may include a second continuous suture.

[0422] According to some embodiments, the method may further include: placing a motility-restricting device on the fundus of the stomach, forming a pouch in the fundus, at least partially arranging the motility-restricting device within the pouch, and enclosing the motility-restricting device within the fundus of the stomach by at least partially closing the pouch with fasteners. The motility-restricting device may be positioned between the diaphragm and the lower esophageal sphincter to prevent the lower esophagus from sliding into the patient's thoracic cavity through the diaphragmatic hiatus. The motility-restricting device may be enclosed after the fundus portion of the stomach has been attached to the esophagus. Additionally, the pouch may be formed to be open in at least two locations to create a channel through which the motility-restricting device extends. In one example, the fundus may be attached to the diaphragm.

[0423] 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 provide power to energy-consuming components of the implant. Examples of energy-consuming components include controllers, sensors, electrodes, etc., as described above in conjunction with previous embodiments and examples. Therefore, in some embodiments, the energy source may be configured to provide power to the electrode arrangement or electrodes as described above.

[0424] An implantable power source can be configured to be disposed within or integrated with an implantable device such as a motion-limiting device, support device, attachment device, core, or cover, according to any of the embodiments and examples described above. In some examples, the power source or a portion thereof can be configured to be implanted (e.g., subcutaneously) onto the outside of the device or implantable device.

[0425] Energy sources may include primary batteries (or galvanic cells) designed to be discarded after use and not recharged like secondary batteries. Alternatively or otherwise, energy sources may include secondary batteries (or rechargeable batteries) designed to be rechargeable.

[0426] According to some embodiments, the implantable energy source can be configured to be charged by an external energy source (i.e., an energy source disposed outside the patient's body). This can be achieved, for example, by an implantable charger configured to be electrically connected to the implantable energy source and capable of charging the implantable energy source by an external energy source. Thus, the charger can be configured to transfer power from outside the patient's body to the implantable energy source. For example, the power can be transferred wirelessly from an external source, and in some examples, the charger may include an electromagnetic coil to facilitate the transfer.

[0427] According to some embodiments, the charger can be configured to control the charging of the implantable energy source by controlling the reception of power from an external energy source at the implantable charger and / or by controlling the transfer of power from an external energy source to the implantable charger.

[0428] According to some embodiments, the charging of the implantable energy source can be controlled based on its functional state. For example, this can be achieved by controlling the power supplied or transmitted by an external energy source or by controlling the power received by the charger as described above. Additionally, in some examples, charging can be controlled by controlling the power supplied from the charger to the implantable energy source (i.e., by controlling the power output from the charger or by controlling the power received or absorbed by the implantable energy source). Therefore, it should be understood that the charging of the implantable energy source can be controlled by changing or controlling the power supplied by the external energy source at any point along the path to the implantable energy source. As illustrated above, the power supplied to the implantable energy source can therefore be controlled at the external energy source, the charger, or the implantable energy source itself.

[0429] For example, the functional status of an implanted power source can include its electrical charge level or temperature. Temperature, for instance, can be related to the power source, muscle tissue, or implant components such as electrode placement. Therefore, charging can be reduced or even stopped when the electrical charge level (or accumulated energy) reaches its upper limit, or when the temperature exceeds a predetermined range.

[0430] According to some embodiments, a controller (or processor or control circuitry) may be provided for controlling various components or functions of the implanted device or apparatus according to any of the embodiments described above. For example, the controller may be configured to include the functional status of the implanted energy source in signals transmitted to the outside of the body.

[0431] The controller can be configured to be operatively connected to the electrode arrangement for controlling electrical stimulation of muscle tissue. For example, the stimulation can be controlled to stimulate the muscle tissue via a series of electrical pulses. The electrical pulses can be characterized by their voltage and / or current. In some examples, a pulse with a first polarity may be followed by a pulse with an opposite second polarity. For example, the first polarity may be a positive current relative to the direction of current flow, and the second polarity may be a negative current. Alternatively or otherwise, the first polarity may be characterized by a positive voltage relative to a reference voltage (e.g., ground), and the second polarity may be characterized by a negative voltage.

[0432] The controller can be configured to generate pulsed electrical stimulation signals with pulse frequencies ranging from 0.01 to 150 Hz. The pulse duration can be from 0.01 to 100 ms, and the pulse amplitude is in the range of 1 to 15 mA. Specific examples of the electrical stimulation signal may feature a pulse frequency of 0.15 to 0.25 Hz, a pulse duration of 20 to 30 ms, and a pulse amplitude of 3 to 10 mA.

[0433] The controller can be further configured to generate pulsed electrical stimulation signals with variable components, including different durations, such as accumulation periods with gradually increasing amplitude, stimulation periods with sustained stimulation, and pause periods with paused stimulation. Thus, in one example, the electrical stimulation signal may include an accumulation period of 0.01 to 2 s, a stimulation period of 1 to 60 s, and a pause period of 0.01 to 60 s. During the accumulation and stimulation periods, the signal may include a pulse frequency of 1 to 50 Hz and a pulse duration of 0.1 to 10 ms. These durations can vary and combine depending on the desired stimulation of the muscle tissue and can be further varied based on responses that can be monitored, for example, by sensors connected to the controller. For example, the sensors may be configured to measure muscle movement responses in the muscle tissue, which may be measured as mechanical or electrical responses.

[0434] According to some embodiments, an implantable sensor can be provided for sensing action potentials generated by pacemaker cells in muscle tissue. The sensor can be communicatively coupled to a controller that can be configured to control electrical stimulation based at least in part on the sensed action potentials. This may be particularly advantageous when stimulating smooth muscle tissue, which may exhibit periodic contractions regulated by pacemaker cells. Therefore, this embodiment allows for targeted modulation of the electrical stimulation signal to amplify the sensed action potentials.

[0435] According to some embodiments, the controller may include an external controller configured to be disposed outside the patient's body, and an internal controller (or implantable controller) configured to be disposed inside the patient's body. The wireless remote control may include an external signal transmitter configured to communicate with the internal controller. Therefore, the internal controller may be configured to receive signals transmitted by the external signal transmitter and, based on those signals, control the operation of the device or medical implant. In some examples, the signal may be selected from the group consisting of: sound signals, ultrasound signals, electromagnetic signals, infrared signals, visible light signals, ultraviolet light signals, laser signals, microwave signals, radio wave signals, X-ray radiation signals, and gamma radiation signals.

[0436] According to one embodiment of the motion limiting device defined in any of the above aspects, the average surface roughness is Ra as defined in ISO 21920-2:2021.

[0437] According to one embodiment of the motion limiting device as defined in any of the above aspects, the average surface roughness is Sa as defined in ISO 25178-2:2021.

[0438] According to one embodiment of the motion limiting device as defined in any of the above aspects, the average surface roughness is in the range of 0.1 to 0.5 μm.

[0439] According to one embodiment of the motion limiting device as defined in any of the above aspects, the average surface roughness is in the range of 0.1 to 0.3 μm.

[0440] According to one embodiment of the motion restriction device as defined in any of the above aspects, the implantable motion restriction device includes a polymer material.

[0441] According to one embodiment of the motion restriction device as defined in any of the foregoing aspects, the implantable motion restriction device includes at least one of silicone-based materials and polyurethane-based materials.

[0442] According to one embodiment of the motion restriction device as defined in any of the foregoing aspects, the second solid material includes at least one of a polypropylene-based material and a polyethylene-based material.

[0443] According to one embodiment of the motion restriction device as defined in any of the foregoing aspects, the Shore A indentation hardness measured on the outer surface is at least 50.

[0444] According to one embodiment of the motion restriction device defined in any of the above aspects, the indentation hardness is the indentation hardness measured by the hardness tester method as defined in ISO 48-4:2018 Part 4.

[0445] According to one embodiment of the motion restriction device as defined in any of the above aspects, the Shore A indentation hardness measured on the outer surface does not exceed 70.

[0446] According to one embodiment of the motion restriction device as defined in any of the above aspects, the Shore A indentation hardness measured on the outer surface is in the range of 55 to 65.

[0447] According to one embodiment, an implantable motion restriction device includes a core component and at least one external component, the core component and the at least one external component being configured to assemble into an implantable motion restriction device.

[0448] According to one embodiment, the core component includes fluid.

[0449] According to one embodiment, the core component comprises a liquid with a density of less than 1000 kg / m³.

[0450] According to one embodiment, the liquid includes at least one selected from the following list: oil-based liquids and alcohol-based liquids.

[0451] According to one embodiment, the core component includes gas.

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

[0453] According to one embodiment, the core component includes a solid polymer material surrounding an enclosing material, wherein the enclosing material is harder than the solid polymer material.

[0454] According to one embodiment, the gas in the plurality of volumes surrounded by the surrounding material accounts for at least 10% of the volume of the second volume, more preferably at least 20% of the volume of the second volume, even more preferably at least 30% of the volume of at least one external component, even more preferably at least 40% of the volume of the second volume, even more preferably at least 50% of the volume of the second volume, even more preferably at least 60% of the volume of the second volume, even more preferably at least 70% of the volume of the second volume, even more preferably at least 80% of the volume of the second volume, even more preferably at least 90% of the volume of the second volume.

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

[0456] According to one embodiment, the implantable motion-limiting device includes a contrast agent.

[0457] According to one embodiment, the implantable motion restriction device includes the contrast agent BaSO4.

[0458] According to one embodiment, the implantable motion restriction device includes a contrast agent comprising 1% to 15% by weight of the implantable motion restriction device.

[0459] According to one embodiment, the implantable motion restriction device includes a contrast agent comprising 1% to 6% by weight of the implantable motion restriction device.

[0460] According to one embodiment, the implantable motion restriction device includes a contrast agent comprising 8% to 15% by weight of the implantable motion restriction device.

[0461] In some embodiments, the core component comprises 8% to 15% by weight of contrast agent.

[0462] In some embodiments, at least one external component includes a contrast agent comprising 1% to 6% by weight of the implantable motion-limiting device.

[0463] Various apparatuses and methods according to the foregoing aspects can be combined with any of the features, examples, and effects described in this application.

[0464] According to one embodiment of the motion restriction device defined in any of the above aspects, the indentation hardness is the indentation hardness measured by the hardness tester method as defined in ISO 48-4:2018 Part 4.

[0465] According to one embodiment of the motion restriction device as defined in any of the above aspects, the Shore A indentation hardness measured on the outer surface does not exceed 70.

[0466] According to one embodiment of the motion restriction device as defined in any of the above aspects, the Shore A indentation hardness measured on the outer surface is in the range of 55 to 65.

[0467] According to one embodiment, the core component includes fluid.

[0468] According to one embodiment, the core component comprises a liquid with a density of less than 1000 kg / m³.

[0469] According to one embodiment, the liquid includes at least one selected from the following list: oil-based liquid and alcohol-based liquid.

[0470] According to one embodiment, the core component includes gas.

[0471] According to one embodiment, the core component includes multiple volumes of gas surrounded by a surrounding material.

[0472] According to one embodiment, the core component includes a solid polymer material surrounding an enclosing material, wherein the enclosing material is harder than the solid polymer material.

[0473] According to one embodiment, the gas in the plurality of volumes surrounded by the surrounding material accounts for at least 10% of the volume of the second volume, more preferably at least 20% of the volume of the second volume, and even more preferably at least 30% of the volume of the outer component.

[0474] According to one embodiment, the surrounding material includes glass.

[0475] Further, an implantable medical device for treating reflux disease is provided. The implantable medical device includes a motion-limiting device configured to be fixed to the stomach wall to prevent movement of the lower esophageal sphincter relative to the diaphragm. The motion-limiting device includes a first component, a second component, and a first spacing element. The first and second components are configured to connect with each other to form at least a portion of the functional motion-limiting device. The first and second components are separable from each other such that they can independently pass through the gastrointestinal tract, and the first spacing element is configured to form a space between the first and second components. This space is configured to allow fibrotic tissue to grow inwardly between portions of the first and second components. The space is at least partially defined by a first surface of the first component and a second surface of the second component, wherein the first and second surfaces are positioned relative to each other when the first and second components are connected. A segment of a first straight line is defined by a first point on the first surface and a second point on the second surface, and the segment of the first straight line is greater than 1 mm. A segment of a second straight line is defined by a third point on the first surface and a fourth point on the second surface. The segment of the second straight line is greater than 1 mm, and the first and second straight lines are parallel. The first and second straight lines intersect with the third straight line, which also intersects with the center of gravity of the functional movement restriction device. The distance between the first and second straight lines is greater than 2 mm to allow fibrotic tissue to grow inward, thereby helping to fix the functional movement restriction device to the stomach wall.

[0476] According to one embodiment, the first spacing element is integrated in at least one of the first component and the second component, and the first spacing element may protrude from the surface of at least one of the first component and the second component.

[0477] According to one embodiment, the implantable medical device further includes a first individual spacing component, the first individual spacing component including a first spacing element.

[0478] According to one embodiment, at least one of the first component and the second component may further include a recess configured to receive a portion of the first spacing element.

[0479] In any embodiment herein, the first spacing element may include at least a first portion and a second portion configured to be placed at a distance from each other.

[0480] According to one embodiment, the implantable medical device further includes at least a third component, and the first, second, and third components can be configured to connect with each other to form at least a portion of a functional motion restriction device.

[0481] The implantable medical device according to any embodiment of this document may further include a second spacing element, and the first spacing element may be configured to form a space between the first component and the second component, and the second spacing element may be configured to form a space between the first component and the third component. The first spacing element and the second spacing element may be portions of separate spacing components.

[0482] According to one embodiment, at least one of the first component, the second component, and the third component may include a recess configured to receive a portion of the spacing element.

[0483] According to one embodiment, the volume of the space formed by the spacing elements can exceed 100 mm3.

[0484] According to one embodiment, the space in the implantable medical device forms a recess, and the recess has a depth of more than 2 mm and a width of more than 1 mm.

[0485] According to one embodiment, the spacing element is configured to prevent at least one of the following:

[0486] The rotation between the first component and the second component, the linear motion between the first component and the second component along the first direction, and the linear motion between the first component and the second component along the first direction.

[0487] According to one embodiment, the first individual spacing member is configured to be placed at the center of the functional motion restriction device, and the center of gravity of the first individual spacing member may substantially coincide with the center of gravity of the functional motion restriction device.

[0488] According to one embodiment, a first individual spacing member includes at least one edge, the edge including at least a first surface and a second surface. The first surface of the edge may be configured to engage with a surface of a first member, and the second surface of the flange is configured to engage with a surface of a second member. The first and second surfaces of at least one edge may be parallel. A first individual spacing member may include at least two edges. A first edge may include at least a first surface and a second surface, the first surface of the first edge being configured to engage with a surface of the first member, and the second surface of the first edge being configured to engage with a surface of the second member. A second edge may include at least a first surface and a second surface, the first surface of the second edge being configured to engage with a surface of the first member, and the second surface of the second edge being configured to engage with a surface of a third member.

[0489] According to one embodiment, the angle formed by the first surface of the first edge and the first surface of the second edge relative to each other is in the range of 20° to 70°.

[0490] According to one embodiment, the angle formed by the first surface of the first edge and the first surface of the second edge relative to each other is in the range of 40° to 50°.

[0491] According to one embodiment, the first surface of the first edge and the first surface of the second edge are perpendicular.

[0492] According to one embodiment, the first spacing element may be configured to engage with a recess in at least one of the first and second components along the length axis of the spacing element, and the portion of the first spacing element configured to enter the recess of the second component may include at least one surface inclined relative to the length axis of the spacing element.

[0493] According to one embodiment, the inclined surface of the first spacing element can be configured to face the surface of a recess in at least one of the first and second components, the angle of inclination of the surface of the recess being different from the angle of the first spacing element, wherein a point on the inclined surface of the first spacing element is configured to abut against a point on the inclined surface of the recess.

[0494] According to one embodiment, the length by which the inclined surface of the first spacing element abuts against the inclined surface of the recess is less than half the length of the inclined surface of the first spacing element.

[0495] According to one embodiment, the length by which the inclined surface of the first spacing element abuts against the inclined surface of the recess is less than one-third of the length of the inclined surface of the first spacing element.

[0496] According to one embodiment, when a portion of the first spacing element is inserted into the recess, the length of the inclined surface of the first spacing element abutting the inclined surface of the recess is less than half the depth of the recess, measured along a direction coinciding with the length axis of the first spacing element.

[0497] According to one embodiment, the portion of the first spacing element configured to enter the recess of the second component includes a tapered portion.

[0498] According to one embodiment, the tapered portion gradually tapers at an angle ranging from 20° to 100°.

[0499] According to one embodiment, the recess in at least one of the first and second components is tapered, such that when the tapered portion of the first spacing element is inserted into the recess, two opposite surfaces of the tapered portion of the first spacing element face two opposite surfaces of the tapered recess. The tapered recess may taper gradually at an angle ranging from 30° to 135°.

[0500] According to one embodiment, the tapered portion of the first spacing element gradually tapers at a first angle, and the tapered recess in at least one of the first and second components gradually tapers at a second angle, wherein the second angle is greater than the first angle. The second angle may be more than 3° greater than the first angle, or more than 5° greater than the first angle, or more than 10° greater than the first angle.

[0501] According to one embodiment, the tapered portion of the first spacing element and the tapered recess in at least one of the first and second components are conical or truncated conical.

[0502] According to one embodiment, the tapered portion of the first spacing element is in the shape of a pyramid with a polygonal base.

[0503] According to one embodiment, the portion of the first spacing element configured to enter the recess of the first or second component includes at least one surface having curvature.

[0504] According to one embodiment, the curved surface of the first spacing element is configured to face the surface of a recess in at least one of the first and second components. Points on the curved surface of the first spacing element are configured to abut against points on the surface of the recess.

[0505] According to one embodiment, when the first spacing element is positioned in a recess in at least one of the first and second components, the length by which the curved surface of the first spacing element abuts against the surface of the recess is less than half the length of the inclined surface of the first spacing element.

[0506] According to one embodiment, when a portion of the first spacing element is inserted into the recess, the length by which the curved surface of the first spacing element abuts against the surface of the recess is less than one-third of the length of the inclined surface of the first spacing element.

[0507] According to one embodiment, when a portion of the first spacing element is inserted into the recess, the length by which the curved surface of the first spacing element abuts against the surface of the recess is less than one-third of the length of the inclined surface of the first spacing element.

[0508] According to one embodiment, when a portion of the first spacing element is inserted into the recess, the length of contact between the curved surface of the first spacing element and the surface of the recess is less than half the depth of the recess, measured along a direction coinciding with the length axis of the first spacing element.

[0509] According to one embodiment, the portion of the first spacing element configured to enter the recess of the second component includes at least one surface having a first curvature and a second curvature extending in a vertical direction. The portion of the first spacing element configured to enter the recess of the second component may include at least one spherical surface.

[0510] According to one embodiment, at least one of the first and second components has a concave shape, such that when a portion of the first spacing element configured to enter the concave part of the first or second component is inserted into the concave part, two curved surfaces on opposite sides of the portion of the first spacing element configured to enter the concave part of the first or second component face two surfaces on opposite sides of the conical concave part.

[0511] According to one embodiment, the recess in at least one of the first component and the second component includes at least one surface having a curvature. The recess in at least one of the first component and the second component may include at least one surface having a first curvature and a second curvature extending in a vertical direction.

[0512] According to one embodiment, the recess in at least one of the first component and the second component includes at least one spherical surface.

[0513] According to one embodiment, the portion of the first spacing element configured to enter a recess in the first or second component includes at least one surface with a curvature having a first radius, and the recess in at least one of the first and second components includes at least one surface with a curvature having a second radius. According to one embodiment, the second radius is longer than the first radius.

[0514] According to one embodiment, the portion of the first spacing element configured to enter the recess of the first component or the second component includes at least one surface having a first curvature and a second curvature extending in a vertical direction.

[0515] According to one embodiment, the recess in at least one of the first component and the second component includes at least one surface having a first curvature and a second curvature extending in a vertical direction, and the sum of the radii of the first curvature and the second curvature of the recess in at least one of the first component and the second component is greater than the sum of the radii of the first curvature and the second curvature of the portion of the first spacing element configured to enter the recess.

[0516] According to one embodiment, the functional motion limiting device or the boundary of the functional motion limiting device may be elongated. The functional motion limiting device may be elongated, with the longest length being more than 1.5 times the widest width.

[0517] According to one embodiment, the functional motion limiting device includes a bending portion, and the bending center axis of the functional motion limiting device follows the elongation of the functional motion limiting device.

[0518] According to one embodiment, a first portion of the functional motion restriction device is configured such that a first portion of the bending central axis is parallel to the patient's caudal-cranial axis, and a second portion of the bending central axis is tilted more than 5° relative to the patient's caudal-cranial axis.

[0519] According to one embodiment, the second portion of the curved central axis is configured to be positioned in the stomach and tilted toward the esophagus.

[0520] According to one embodiment, at least one of the first component and the second component has a shape corresponding to an ellipsoidal wedge or a truncated ellipsoidal wedge.

[0521] According to one embodiment, at least one of the first component and the second component has a shape corresponding to a spherical wedge or a truncated spherical wedge.

[0522] At least one of the first and second components may have a shape corresponding to a portion of an ellipsoidal wedge or a portion of a truncated ellipsoidal wedge.

[0523] According to one embodiment, at least one of the first and second components has a shape corresponding to a semi-ellipsoidal wedge or a truncated semi-ellipsoidal wedge.

[0524] At least one of the first and second components may have a shape corresponding to a portion of a spherical wedge or a portion of a truncated spherical wedge.

[0525] According to one embodiment, at least one of the first and second components has a shape corresponding to a hemispherical wedge or a truncated hemispherical wedge.

[0526] According to one embodiment, at least one of the first component and the second component has a shape corresponding to an ellipsoidal segment or a portion thereof.

[0527] According to one embodiment, at least one of the first component and the second component has a shape corresponding to a spherical segment or a portion thereof.

[0528] In any embodiment, the functional motion restriction device or the boundary of the functional motion restriction device may have a shape corresponding to an ellipsoid or a truncated ellipsoid.

[0529] According to one embodiment, the functional motion restriction device or the boundary of the functional motion restriction device has a shape corresponding to a sphere or a truncated sphere.

[0530] According to one embodiment, at least the periphery of at least one of the first component and the second component has a shape corresponding to a cylinder.

[0531] According to one embodiment, the combined periphery of the first component and the second component has a shape corresponding to a cylinder.

[0532] According to one embodiment, the periphery of the first component has a shape corresponding to a first cylinder having a first radius, and the periphery of the second component has a shape corresponding to a second cylinder having a second radius, and the first radius and the second radius are different.

[0533] According to one embodiment, the functional motion restriction device or the boundary of the functional motion restriction device includes a stadium-shaped section or a truncated stadium-shaped section.

[0534] According to one embodiment, the functional motion restriction device includes a curved stadium-shaped cross section or a truncated curved stadium-shaped cross section.

[0535] According to one embodiment, the periphery of a first component has a shape corresponding to a cylindrical or ellipsoidal segment, and the periphery of a second component has a shape corresponding to a cylindrical or ellipsoidal segment. The first component includes at least one protrusion projecting from a first bottom surface, and the second component includes at least one recess on the first bottom surface. The at least one protrusion is adapted to be at least partially disposed in the at least one recess. The at least one protrusion may be adapted to engage with the at least one recess, and the first component may further include at least one recess on a second bottom surface.

[0536] The position of at least one protrusion may coincide with the position of at least one recess, such that when the first component is viewed along the normal direction of the first bottom surface, the recess and the protrusion overlap. The at least one recess may be recessed into the at least one protrusion.

[0537] According to one embodiment, at least one protrusion may be in the shape of a pyramid with a polygonal base.

[0538] According to one embodiment, the first component further includes at least one protrusion located on the second bottom surface, and the second component may further include at least one protrusion located on the second bottom surface. The second component may further include at least one recess located on the second bottom surface.

[0539] According to one embodiment, the implantable medical device further includes a third component, and the first component further includes a recess located on a second bottom surface, the second component further includes a protrusion projecting from the second bottom surface, and the third component includes a protrusion projecting from the first bottom surface and a recess located on the second bottom surface, the protrusion of the first component being configured to at least partially insert into the recess of the second component, the protrusion of the second component being configured to at least partially insert into the recess of the third component, and the first, second, and third components being configured to assemble to form at least a portion of a functional implantable medical device, wherein the recess and the protrusion stabilize the components relative to each other during assembly.

[0540] According to one embodiment, the area of ​​the first bottom surface of the first component is smaller than the area of ​​the first bottom surface of the second component.

[0541] According to one embodiment, at least one protrusion projecting from the first bottom surface of the first component includes a spacing element.

[0542] According to one embodiment, the medical device is further configured to treat obesity by configuring a motion-restricting device to protrude into the stomach, thereby reducing the volume of the gastric cavity. For the purpose of treating obesity, the volume of the functional motion-restricting device can be in the range of 100 cm³ to 1000 cm³, or in the range of 100 cm³ to 500 cm³. For the purpose of treating obesity, the length of the functional implantable medical device can be in the range of 2.5 cm to 15 cm, or in the range of 5 cm to 15 cm, or in the range of 7 cm to 15 cm, or in the range of 8 cm to 15 cm, or in the range of 8 cm to 12 cm.

[0543] In any embodiment herein, the motion restriction device may include a surface friction-reducing coating covering at least a portion of the surface of the motion restriction device. The surface friction-reducing coating may be configured to reduce friction between the motion restriction device and the gastric wall tissue that at least partially encloses the motion restriction device.

[0544] The implantable medical device may further include a sensor configured to sense at least one of force and pressure for monitoring the pressure or force exerted by the implantable motion-limiting device on the patient's stomach wall.

[0545] According to one embodiment, the motion restriction device includes a first portion and a second portion different from the first portion. The first portion has a first volume surrounded by a material suitable for implanting the motion restriction device, and the second portion has a second volume surrounded by a material suitable for implanting the motion restriction device. The first volume and the second volume can be of the same size, and the density of the first volume can be higher than that of the second volume, and the density of the second volume can be lower than 1000 kg / m³.

[0546] According to one embodiment, an implantable medical device can be configured to be fixed to a patient's stomach wall to serve as a motion-restricting device that prevents the lower esophageal sphincter from moving relative to the diaphragm. The motion-restricting device includes a first component, a second component, and a spacing element. The first and second components can be configured to connect with each other to form at least a portion of the functional motion-restricting device. With at least one of the first and second components positioned within the stomach, the first and second components can be separated from each other, allowing them to pass independently through the gastrointestinal tract, and the spacing element is configured to form a space between the first and second components. This space is configured to allow fibrotic tissue to grow inward between the portions of the first and second components, and the space forms a recess in the functional motion-restricting device. The width of the recess can be greater than 1 mm and the depth can be greater than 2 mm to allow fibrotic tissue to grow inward, thereby facilitating the fixation of the functional motion-restricting device to the stomach wall.

[0547] According to one embodiment, the first spacing element is integrated in at least one of the first component and the second component, and the first spacing element may protrude from the surface of at least one of the first component and the second component.

[0548] According to one embodiment, the implantable medical device further includes a first individual spacing component, the first individual spacing component including a first spacing element.

[0549] According to one embodiment, at least one of the first component and the second component may further include a recess configured to receive a portion of the first spacing element.

[0550] In any embodiment herein, the first spacing element may include at least a first portion and a second portion configured to be placed at a distance from each other.

[0551] According to one embodiment, the implantable medical device further includes at least a third component, and the first, second, and third components can be configured to connect with each other to form at least a portion of a functional motion restriction device.

[0552] The implantable medical device according to any embodiment of this document may further include a second spacing element, and the first spacing element may be configured to form a space between the first component and the second component, and the second spacing element may be configured to form a space between the first component and the third component. The first spacing element and the second spacing element may be portions of separate spacing components.

[0553] According to one embodiment, at least one of the first component, the second component, and the third component may include a recess configured to receive a portion of the spacing element.

[0554] According to one embodiment, the volume of the space formed by the spacing elements can exceed 100 mm. 3 .

[0555] According to one embodiment, the space in the implantable medical device forms a recess, and the recess has a depth of more than 2 mm and a width of more than 1 mm.

[0556] According to one embodiment, the spacing element is configured to prevent at least one of the following: rotation between the first component and the second component, linear movement between the first component and the second component along a first direction, and linear movement between the first component and the second component along a first direction.

[0557] According to one embodiment, the first individual spacing member is configured to be placed at the center of the functional motion restriction device, and the center of gravity of the first individual spacing member may substantially coincide with the center of gravity of the functional motion restriction device.

[0558] According to one embodiment, a first individual spacing member includes at least one edge, the edge including at least a first surface and a second surface. The first surface of the edge may be configured to engage with a surface of a first member, and the second surface of the flange is configured to engage with a surface of a second member. The first and second surfaces of at least one edge may be parallel. A first individual spacing member may include at least two edges. A first edge may include at least a first surface and a second surface, the first surface of the first edge being configured to engage with a surface of the first member, and the second surface of the first edge being configured to engage with a surface of the second member. A second edge may include at least a first surface and a second surface, the first surface of the second edge being configured to engage with a surface of the first member, and the second surface of the second edge being configured to engage with a surface of a third member.

[0559] According to one embodiment, the angle formed by the first surface of the first edge and the first surface of the second edge relative to each other is in the range of 20° to 70°.

[0560] According to one embodiment, the angle formed by the first surface of the first edge and the first surface of the second edge relative to each other is in the range of 40° to 50°.

[0561] According to one embodiment, the first surface of the first edge and the first surface of the second edge are perpendicular.

[0562] According to one embodiment, the first spacing element may be configured to engage with a recess in at least one of the first and second components along the length axis of the spacing element, and the portion of the first spacing element configured to enter the recess of the second component may include at least one surface inclined relative to the length axis of the spacing element.

[0563] According to one embodiment, the inclined surface of the first spacing element can be configured to face the surface of a recess in at least one of the first and second components, the angle of inclination of the surface of the recess being different from the angle of the first spacing element, wherein a point on the inclined surface of the first spacing element is configured to abut against a point on the inclined surface of the recess.

[0564] According to one embodiment, the length by which the inclined surface of the first spacing element abuts against the inclined surface of the recess is less than half the length of the inclined surface of the first spacing element.

[0565] According to one embodiment, the length by which the inclined surface of the first spacing element abuts against the inclined surface of the recess is less than one-third of the length of the inclined surface of the first spacing element.

[0566] According to one embodiment, when a portion of the first spacing element is inserted into the recess, the length of the inclined surface of the first spacing element abutting the inclined surface of the recess is less than half the depth of the recess, measured along a direction coinciding with the length axis of the first spacing element.

[0567] According to one embodiment, the portion of the first spacing element configured to enter the recess of the second component includes a tapered portion.

[0568] According to one embodiment, the tapered portion gradually tapers at an angle ranging from 20° to 100°.

[0569] According to one embodiment, the recess in at least one of the first and second components is tapered, such that when the tapered portion of the first spacing element is inserted into the recess, two opposite surfaces of the tapered portion of the first spacing element face two opposite surfaces of the tapered recess. The tapered recess may taper gradually at an angle ranging from 30° to 135°.

[0570] According to one embodiment, the tapered portion of the first spacing element gradually tapers at a first angle, and the tapered recess in at least one of the first and second components gradually tapers at a second angle, wherein the second angle is greater than the first angle. The second angle may be more than 3° greater than the first angle, or more than 5° greater than the first angle, or more than 10° greater than the first angle.

[0571] According to one embodiment, the tapered portion of the first spacing element and the tapered recess in at least one of the first and second components are conical or truncated conical.

[0572] According to one embodiment, the tapered portion of the first spacing element is in the shape of a pyramid with a polygonal base.

[0573] According to one embodiment, the portion of the first spacing element configured to enter the recess of the first or second component includes at least one surface having curvature.

[0574] According to one embodiment, the curved surface of the first spacing element is configured to face the surface of a recess in at least one of the first and second components. Points on the curved surface of the first spacing element are configured to abut against points on the surface of the recess.

[0575] According to one embodiment, when the first spacing element is positioned in a recess in at least one of the first and second components, the length by which the curved surface of the first spacing element abuts against the surface of the recess is less than half the length of the inclined surface of the first spacing element.

[0576] According to one embodiment, when a portion of the first spacing element is inserted into the recess, the length by which the curved surface of the first spacing element abuts against the surface of the recess is less than one-third of the length of the inclined surface of the first spacing element.

[0577] According to one embodiment, when a portion of the first spacing element is inserted into the recess, the length by which the curved surface of the first spacing element abuts against the surface of the recess is less than one-third of the length of the inclined surface of the first spacing element.

[0578] According to one embodiment, when a portion of the first spacing element is inserted into the recess, the length of contact between the curved surface of the first spacing element and the surface of the recess is less than half the depth of the recess, measured along a direction coinciding with the length axis of the first spacing element.

[0579] According to one embodiment, the portion of the first spacing element configured to enter the recess of the second component includes at least one surface having a first curvature and a second curvature extending in a vertical direction. The portion of the first spacing element configured to enter the recess of the second component may include at least one spherical surface.

[0580] According to one embodiment, at least one of the first and second components has a concave shape, such that when a portion of the first spacing element configured to enter the concave part of the first or second component is inserted into the concave part, two curved surfaces on opposite sides of the portion of the first spacing element configured to enter the concave part of the first or second component face two surfaces on opposite sides of the conical concave part.

[0581] According to one embodiment, the recess in at least one of the first component and the second component includes at least one surface having a curvature. The recess in at least one of the first component and the second component may include at least one surface having a first curvature and a second curvature extending in a vertical direction.

[0582] According to one embodiment, the recess in at least one of the first component and the second component includes at least one spherical surface.

[0583] According to one embodiment, the portion of the first spacing element configured to enter a recess in the first or second component includes at least one surface with a curvature having a first radius, and the recess in at least one of the first and second components includes at least one surface with a curvature having a second radius. According to one embodiment, the second radius is longer than the first radius.

[0584] According to one embodiment, the portion of the first spacing element configured to enter the recess of the first component or the second component includes at least one surface having a first curvature and a second curvature extending in a vertical direction.

[0585] According to one embodiment, the recess in at least one of the first component and the second component includes at least one surface having a first curvature and a second curvature extending in a vertical direction, and the sum of the radii of the first curvature and the second curvature of the recess in at least one of the first component and the second component is greater than the sum of the radii of the first curvature and the second curvature of the portion of the first spacing element configured to enter the recess.

[0586] According to one embodiment, the functional motion limiting device or the boundary of the functional motion limiting device may be elongated. The functional motion limiting device may be elongated, with the longest length being more than 1.5 times the widest width.

[0587] According to one embodiment, the functional motion limiting device includes a bending portion, and the bending center axis of the functional motion limiting device follows the elongation of the functional motion limiting device.

[0588] According to one embodiment, a first portion of the functional motion restriction device is configured such that a first portion of the bending central axis is parallel to the patient's caudal-cranial axis, and a second portion of the bending central axis is tilted more than 5° relative to the patient's caudal-cranial axis.

[0589] According to one embodiment, the second portion of the curved central axis is configured to be positioned in the stomach and tilted toward the esophagus.

[0590] According to one embodiment, at least one of the first component and the second component has a shape corresponding to an ellipsoidal wedge or a truncated ellipsoidal wedge.

[0591] According to one embodiment, at least one of the first component and the second component has a shape corresponding to a spherical wedge or a truncated spherical wedge.

[0592] At least one of the first and second components may have a shape corresponding to a portion of an ellipsoidal wedge or a portion of a truncated ellipsoidal wedge.

[0593] According to one embodiment, at least one of the first and second components has a shape corresponding to a semi-ellipsoidal wedge or a truncated semi-ellipsoidal wedge.

[0594] At least one of the first and second components may have a shape corresponding to a portion of a spherical wedge or a portion of a truncated spherical wedge.

[0595] According to one embodiment, at least one of the first and second components has a shape corresponding to a hemispherical wedge or a truncated hemispherical wedge.

[0596] According to one embodiment, at least one of the first component and the second component has a shape corresponding to an ellipsoidal segment or a portion thereof.

[0597] According to one embodiment, at least one of the first component and the second component has a shape corresponding to a spherical segment or a portion thereof.

[0598] In any embodiment, the functional motion restriction device or the boundary of the functional motion restriction device may have a shape corresponding to an ellipsoid or a truncated ellipsoid.

[0599] According to one embodiment, the functional motion restriction device or the boundary of the functional motion restriction device has a shape corresponding to a sphere or a truncated sphere.

[0600] According to one embodiment, at least the periphery of at least one of the first component and the second component has a shape corresponding to a cylinder.

[0601] According to one embodiment, the combined periphery of the first component and the second component has a shape corresponding to a cylinder.

[0602] According to one embodiment, the periphery of the first component has a shape corresponding to a first cylinder having a first radius, and the periphery of the second component has a shape corresponding to a second cylinder having a second radius, and the first radius and the second radius are different.

[0603] According to one embodiment, the functional motion restriction device or the boundary of the functional motion restriction device includes a stadium-shaped section or a truncated stadium-shaped section.

[0604] According to one embodiment, the functional motion restriction device includes a curved stadium-shaped cross section or a truncated curved stadium-shaped cross section.

[0605] According to one embodiment, the periphery of a first component has a shape corresponding to a cylindrical or ellipsoidal segment, and the periphery of a second component has a shape corresponding to a cylindrical or ellipsoidal segment. The first component includes at least one protrusion projecting from a first bottom surface, and the second component includes at least one recess on the first bottom surface. The at least one protrusion is adapted to be at least partially disposed in the at least one recess. The at least one protrusion may be adapted to engage with the at least one recess, and the first component may further include at least one recess on a second bottom surface.

[0606] The position of at least one protrusion may coincide with the position of at least one recess, such that when the first component is viewed along the normal direction of the first bottom surface, the recess and the protrusion overlap. The at least one recess may be recessed into the at least one protrusion.

[0607] According to one embodiment, at least one protrusion may be in the shape of a pyramid with a polygonal base.

[0608] According to one embodiment, the first component further includes at least one protrusion located on the second bottom surface, and the second component may further include at least one protrusion located on the second bottom surface. The second component may further include at least one recess located on the second bottom surface.

[0609] According to one embodiment, the implantable medical device further includes a third component, and the first component further includes a recess located on a second bottom surface, the second component further includes a protrusion projecting from the second bottom surface, and the third component includes a protrusion projecting from the first bottom surface and a recess located on the second bottom surface, the protrusion of the first component being configured to at least partially insert into the recess of the second component, the protrusion of the second component being configured to at least partially insert into the recess of the third component, and the first, second, and third components being configured to assemble to form at least a portion of a functional implantable medical device, wherein the recess and the protrusion stabilize the components relative to each other during assembly.

[0610] According to one embodiment, the area of ​​the first bottom surface of the first component is smaller than the area of ​​the first bottom surface of the second component.

[0611] According to one embodiment, at least one protrusion projecting from the first bottom surface of the first component includes a spacing element.

[0612] According to one embodiment, the medical device is further configured to treat obesity by configuring a motion-limiting device to protrude into the stomach, thereby reducing the volume of the gastric cavity. For the purpose of treating obesity, the functional motion-limiting device may be 100 cm² in size. 3 Up to 1000cm 3 Within a range, or within 100cm 3 Up to 500cm3 Within a certain range. For the purpose of treating obesity, the length of a functional implantable medical device can be in the range of 2.5cm to 15cm, or in the range of 5cm to 15cm, or in the range of 7cm to 15cm, or in the range of 8cm to 15cm, or in the range of 8cm to 12cm.

[0613] In any embodiment herein, the motion restriction device may include a surface friction-reducing coating covering at least a portion of the surface of the motion restriction device. The surface friction-reducing coating may be configured to reduce friction between the motion restriction device and the gastric wall tissue that at least partially encloses the motion restriction device.

[0614] The implantable medical device may further include a sensor configured to sense at least one of force and pressure for monitoring the pressure or force exerted by the implantable motion-limiting device on the patient's stomach wall.

[0615] According to one embodiment, the motion restriction device includes a first portion and a second portion different from the first portion. The first portion has a first volume surrounded by a material suitable for implanting the motion restriction device, and the second portion has a second volume surrounded by the same material. The first and second volumes can be of equal size, and the density of the first volume can be higher than that of the second volume, while the density of the second volume can be lower than 1000 kg / m³. 3 .

[0616] Further, an implantable medical device for treating reflux disease is provided, comprising a motion restriction device configured to be fixed to the stomach wall to prevent movement of the lower esophageal sphincter relative to the diaphragm. The motion restriction device includes a first component and a second component. The first and second components are configured to be connected to each other to form at least a portion of the functional motion restriction device. The first and second components are disconnectable from each other, allowing them to pass through the gastrointestinal tract independently, and the periphery of the first component has a shape corresponding to a cylindrical or ellipsoidal segment, and the periphery of the second component also has a shape corresponding to a cylindrical or ellipsoidal segment. The first component includes at least one protrusion projecting from a first bottom surface, and the second component includes at least one recess located on the first bottom surface, and the at least one protrusion is adapted to be at least partially disposed within the at least one recess to stabilize the first and second components relative to each other.

[0617] According to one embodiment, at least one protrusion of a first component of the motion limiting device is adapted to engage with at least one recess of a second component of the motion limiting device.

[0618] According to one embodiment, the first component further includes at least one recess located on the second bottom surface.

[0619] According to one embodiment, the location of at least one protrusion coincides with the location of at least one recess, such that when the first component is viewed along the normal direction of the first bottom surface, the recess and the protrusion overlap. The at least one recess may be recessed into the at least one protrusion.

[0620] According to one embodiment, at least one protrusion is adapted to engage with at least one recess along the length axis of the protrusion, and the portion of the protrusion adapted to be at least partially situated in the at least one recess includes at least one surface inclined relative to the length axis of the protrusion.

[0621] According to one embodiment, the surface of the protrusion is inclined and configured to face the recess in the second component at an angle different from the angle of the protrusion. Points on the inclined surface of the protrusion are configured to abut against points on the inclined surface of the recess.

[0622] According to one embodiment, the length by which the inclined surface of the protrusion abuts against the inclined surface of the recess is less than half the length of the inclined surface of the protrusion.

[0623] The length of contact between the inclined surface of the protrusion and the inclined surface of the concave part is less than one-third of the length of the inclined surface of the protrusion.

[0624] According to one embodiment, when a portion of the protrusion is inserted into the recess, the length of the inclined surface of the protrusion abutting the inclined surface of the recess is less than half the depth of the recess, measured along a direction coinciding with the length axis of the protrusion.

[0625] According to one embodiment, the portion of the protrusion configured to enter the recess of the second component includes a tapered portion, and the tapered portion may taper gradually at an angle ranging from 20° to 150°.

[0626] According to one embodiment, the recess in at least one of the first and second components is tapered, such that when the tapered portion of the first spacing element is inserted into the recess, the two surfaces on opposite sides of the protruding tapered portion face the two surfaces on opposite sides of the tapered recess. The tapered recess may taper gradually at an angle ranging from 30° to 155°.

[0627] According to one embodiment, the protruding conical portion gradually tapers at a first angle, and the conical recess in at least one of the first and second components gradually tapers at a second angle, wherein the second angle is greater than the first angle. The second angle may be more than 3° greater than the first angle, or more than 5° greater than the first angle, or more than 10° greater than the first angle.

[0628] According to one embodiment, at least one protrusion is in the shape of a pyramid with a polygonal base.

[0629] According to one embodiment, the first component further includes at least one protrusion located on the second bottom surface, and the second component further includes at least one protrusion located on the second bottom surface. The second component may further include at least one recess located on the second bottom surface.

[0630] According to one embodiment, the implantable medical device further includes a third component. The first component further includes a recess located on a second bottom surface, the second component further includes a protrusion projecting from the second bottom surface, and the third component includes a protrusion projecting from the first bottom surface and a recess located on the second bottom surface. The protrusion of the first component is configured to at least partially insert into the recess of the second component, and the protrusion of the second component is configured to at least partially insert into the recess of the third component, wherein the first, second, and third components are configured to assemble to form at least a portion of a functional implantable medical device, and wherein the recess and protrusion stabilize the portions relative to each other during assembly.

[0631] According to one embodiment, the area of ​​the first bottom surface of the first component is smaller than the area of ​​the first bottom surface of the second component.

[0632] In any embodiment, the functional motion restriction device or the boundary of the functional motion restriction device may have a shape corresponding to an ellipsoid or a truncated ellipsoid.

[0633] According to one embodiment, the functional motion restriction device or the boundary of the functional motion restriction device has a shape corresponding to a sphere or a truncated sphere.

[0634] According to one embodiment, at least the periphery of at least one of the first component and the second component has a shape corresponding to a cylinder.

[0635] According to one embodiment, the combined periphery of the first component and the second component has a shape corresponding to a cylinder.

[0636] According to one embodiment, the periphery of the first component has a shape corresponding to a first cylinder having a first radius, and the periphery of the second component has a shape corresponding to a second cylinder having a second radius, and the first radius and the second radius are different.

[0637] According to one embodiment, the functional motion restriction device or the boundary of the functional motion restriction device includes a stadium-shaped section or a truncated stadium-shaped section.

[0638] According to one embodiment, the functional motion restriction device includes a curved stadium-shaped cross section or a truncated curved stadium-shaped cross section.

[0639] According to one embodiment, the functional motion limiting device or the boundary of the functional motion limiting device may be elongated. The functional motion limiting device may be elongated, with the longest length being more than 1.5 times the widest width.

[0640] According to one embodiment, the functional motion limiting device includes a bending portion, and the bending center axis of the functional motion limiting device follows the elongation of the functional motion limiting device.

[0641] According to one embodiment, a first portion of the functional motion restriction device is configured such that a first portion of the bending central axis is parallel to the patient's caudal-cranial axis, and a second portion of the bending central axis is tilted more than 5° relative to the patient's caudal-cranial axis.

[0642] According to one embodiment, the second portion of the curved central axis is configured to be positioned in the stomach and tilted toward the esophagus.

[0643] According to one embodiment, the protrusion includes a first spacing element configured to form a space between a first component and a second component. This space is configured to allow fibrotic tissue to grow inwardly between portions of the first and second components, wherein the space is at least partially defined by a first surface of the first component and a second surface of the second component, and wherein the first and second surfaces are positioned relative to each other when the first and second components are joined. A segment of a first straight line is defined by a first point on the first surface and a second point on the second surface. The segment of the first straight line is greater than 1 mm. A segment of a second straight line is defined by a third point on the first surface and a fourth point on the second surface. The segment of the second straight line is greater than 1 mm, and the first and second straight lines are parallel. The first and second straight lines intersect a third straight line, which also intersects the center of gravity of the functional movement restriction device, and the distance between the first and second straight lines is greater than 2 mm to allow fibrotic tissue to grow inwardly, thereby facilitating fixation of the functional movement restriction device to the stomach wall.

[0644] According to one embodiment, the protrusion includes a first spacing element configured to form a space between a first component and a second component. This space is configured to allow fibrotic tissue to grow inward between portions of the first and second components, and to form a recess within the functional implantable medical device. The recess has a width greater than 1 mm and a depth greater than 2 mm to allow inward growth of fibrotic tissue, thereby facilitating the fixation of the functional implantable medical device to the stomach wall.

[0645] According to one embodiment, the medical device is further configured to treat obesity by configuring a motion-limiting device to protrude into the stomach, thereby reducing the volume of the gastric cavity. For the purpose of treating obesity, the functional motion-limiting device may be 100 cm² in size.3 Up to 1000cm 3 Within a range, or within 100cm 3 Up to 500cm 3 Within a certain range. For the purpose of treating obesity, the length of a functional implantable medical device can be in the range of 2.5cm to 15cm, or in the range of 5cm to 15cm, or in the range of 7cm to 15cm, or in the range of 8cm to 15cm, or in the range of 8cm to 12cm.

[0646] In any embodiment herein, the motion restriction device may include a surface friction-reducing coating covering at least a portion of the surface of the motion restriction device. The surface friction-reducing coating may be configured to reduce friction between the motion restriction device and the gastric wall tissue that at least partially encloses the motion restriction device.

[0647] The implantable medical device may further include a sensor configured to sense at least one of force and pressure for monitoring the pressure or force exerted by the implantable motion-limiting device on the patient's stomach wall.

[0648] According to one embodiment, the motion restriction device includes a first portion and a second portion different from the first portion. The first portion has a first volume surrounded by a material suitable for implanting the motion restriction device, and the second portion has a second volume surrounded by the same material. The first and second volumes can be of equal size, and the density of the first volume can be higher than that of the second volume, while the density of the second volume can be lower than 1000 kg / m³. 3 .

[0649] The present invention further provides an apparatus for treating reflux disease in human patients. The apparatus includes an implantable motion-limiting device, the shape and size of which allow it to be positioned against a portion of the fundus wall of a patient's stomach, such that the motion-limiting device is implanted between the patient's diaphragm and a portion of the gastric fundus wall, and such that movement of the patient's lower esophageal sphincter toward the diaphragm is restricted to prevent the lower esophageal sphincter from slipping into the patient's thoracic cavity through a hiatus in the diaphragm. 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 impedance sensor and a stimulation controller, the impedance sensor being configured to measure changes in impedance within the tissue of the lower esophageal sphincter or esophageal tissue to detect swallowing, and the stimulation controller being configured to control the electrical stimulation of the lower esophageal sphincter in response to a signal from the impedance sensor.

[0650] According to one embodiment, the device further includes a reference electrode connected to a stimulation controller, wherein the stimulation controller is configured to generate the sensor's output based on the electrical interaction between the impedance sensor and the reference electrode.

[0651] According to one embodiment, the stimulation controller is configured to generate a time-varying signal having frequency components that vary in the range of 1 to 10 kHz.

[0652] According to one embodiment, the stimulation controller is configured to generate a time-varying signal having frequency components that vary in the range of 2 to 8 kHz.

[0653] According to one embodiment, the stimulation controller is configured to generate a time-varying signal having frequency components that vary in the range of 4 to 6 kHz.

[0654] According to one embodiment, the electrode arrangement includes at least two electrode elements configured to be disposed on opposite sides of the lower esophageal sphincter.

[0655] According to one embodiment, the device further includes a retainer configured to support at least two electrode elements on opposite sides of the pyloric sphincter.

[0656] According to one embodiment, the device further includes an implantable energy source configured to provide power to the electrodes.

[0657] According to one embodiment, an implantable energy source is disposed inside the motion restriction device.

[0658] Further, an implantable medical device for treating obesity is provided. The implantable medical device is configured to be fixed to the stomach wall and protrude into the stomach, thereby reducing the volume of the stomach cavity. The implantable medical device includes a first component, a second component, and a first spacing element. The first and second components are configured to connect with each other to form at least a portion of a functional implantable medical device. The first and second components are disconnectable from each other, allowing the first and second components to pass through the gastrointestinal tract independently. The first spacing element is configured to form a space between the first and second components. This space is configured to allow fibrotic tissue to grow inward between portions of the first and second components. The space is at least partially defined by a first surface of the first component and a second surface of the second component. When the first and second components are connected, the first and second surfaces are opposite each other. A segment of a first straight line is defined by a first point on the first surface and a second point on the second surface, and the segment of the first straight line is greater than 1 mm. A segment of a second straight line is defined by a third point on the first surface and a fourth point on the second surface, and the segment of the first straight line is greater than 1 mm. The first straight line is parallel to the second straight line, and the first and second straight lines intersect at a third straight line, which also intersects the center of gravity of the functional medical device. The distance between the first and second straight lines is greater than 2 mm to allow fibrotic tissue to grow inward, thereby facilitating the fixation of the functional implantable medical device to the stomach wall.

[0659] Functional implantable medical devices can be as small as 100cm². 3 Up to 1000cm 3 Within a range, or preferably within 100cm 3 Up to 500cm 3 Within the range.

[0660] The length of the functional implantable medical device can be in the range of 2.5cm to 15cm, or more preferably in the range of 5cm to 15cm, or even more preferably in the range of 7cm to 15cm, or even more preferably in the range of 8cm to 15cm, or even more preferably in the range of 8cm to 12cm.

[0661] According to one embodiment, the first spacing element is integrated in at least one of the first component and the second component, and the first spacing element may protrude from the surface of at least one of the first component and the second component.

[0662] According to one embodiment, the implantable medical device further includes a first individual spacing component, the first individual spacing component including a first spacing element.

[0663] According to one embodiment, at least one of the first component and the second component may further include a recess configured to receive a portion of the first spacing element.

[0664] In any embodiment herein, the first spacing element may include at least a first portion and a second portion configured to be placed at a distance from each other.

[0665] According to one embodiment, the implantable medical device further includes at least a third component, and the first, second, and third components can be configured to connect with each other to form at least a portion of a functional motion restriction device.

[0666] The implantable medical device according to any embodiment of this document may further include a second spacing element, and the first spacing element may be configured to form a space between the first component and the second component, and the second spacing element may be configured to form a space between the first component and the third component. The first spacing element and the second spacing element may be portions of separate spacing components.

[0667] According to one embodiment, at least one of the first component, the second component, and the third component may include a recess configured to receive a portion of the spacing element.

[0668] According to one embodiment, the volume of the space formed by the spacing elements can exceed 100 mm. 3 .

[0669] According to one embodiment, the space in the implantable medical device forms a recess, and the recess has a depth of more than 2 mm and a width of more than 1 mm.

[0670] According to one embodiment, the spacing element is configured to prevent at least one of the following: rotation between the first component and the second component, linear movement between the first component and the second component along a first direction, and linear movement between the first component and the second component along a first direction.

[0671] According to one embodiment, the first individual spacing member is configured to be placed at the center of the functional motion restriction device, and the center of gravity of the first individual spacing member may substantially coincide with the center of gravity of the functional motion restriction device.

[0672] According to one embodiment, a first individual spacing member includes at least one edge, the edge including at least a first surface and a second surface. The first surface of the edge may be configured to engage with a surface of a first member, and the second surface of the flange is configured to engage with a surface of a second member. The first and second surfaces of at least one edge may be parallel. A first individual spacing member may include at least two edges. A first edge may include at least a first surface and a second surface, the first surface of the first edge being configured to engage with a surface of the first member, and the second surface of the first edge being configured to engage with a surface of the second member. A second edge may include at least a first surface and a second surface, the first surface of the second edge being configured to engage with a surface of the first member, and the second surface of the second edge being configured to engage with a surface of a third member.

[0673] According to one embodiment, the angle formed by the first surface of the first edge and the first surface of the second edge relative to each other is in the range of 20° to 70°.

[0674] According to one embodiment, the angle formed by the first surface of the first edge and the first surface of the second edge relative to each other is in the range of 40° to 50°.

[0675] According to one embodiment, the first surface of the first edge and the first surface of the second edge are perpendicular.

[0676] According to one embodiment, the first spacing element may be configured to engage with a recess in at least one of the first and second components along the length axis of the spacing element, and the portion of the first spacing element configured to enter the recess of the second component may include at least one surface inclined relative to the length axis of the spacing element.

[0677] According to one embodiment, the inclined surface of the first spacing element can be configured to face the surface of a recess in at least one of the first and second components, the angle of inclination of the surface of the recess being different from the angle of the first spacing element, wherein a point on the inclined surface of the first spacing element is configured to abut against a point on the inclined surface of the recess.

[0678] According to one embodiment, the length by which the inclined surface of the first spacing element abuts against the inclined surface of the recess is less than half the length of the inclined surface of the first spacing element.

[0679] According to one embodiment, the length by which the inclined surface of the first spacing element abuts against the inclined surface of the recess is less than one-third of the length of the inclined surface of the first spacing element.

[0680] According to one embodiment, when a portion of the first spacing element is inserted into the recess, the length of the inclined surface of the first spacing element abutting the inclined surface of the recess is less than half the depth of the recess, measured along a direction coinciding with the length axis of the first spacing element.

[0681] According to one embodiment, the portion of the first spacing element configured to enter the recess of the second component includes a tapered portion.

[0682] According to one embodiment, the tapered portion gradually tapers at an angle ranging from 20° to 100°.

[0683] According to one embodiment, the recess in at least one of the first and second components is tapered, such that when the tapered portion of the first spacing element is inserted into the recess, two opposite surfaces of the tapered portion of the first spacing element face two opposite surfaces of the tapered recess. The tapered recess may taper gradually at an angle ranging from 30° to 135°.

[0684] According to one embodiment, the tapered portion of the first spacing element gradually tapers at a first angle, and the tapered recess in at least one of the first and second components gradually tapers at a second angle, wherein the second angle is greater than the first angle. The second angle may be more than 3° greater than the first angle, or more than 5° greater than the first angle, or more than 10° greater than the first angle.

[0685] According to one embodiment, the tapered portion of the first spacing element and the tapered recess in at least one of the first and second components are conical or truncated conical.

[0686] According to one embodiment, the tapered portion of the first spacing element is in the shape of a pyramid with a polygonal base.

[0687] According to one embodiment, the portion of the first spacing element configured to enter the recess of the first or second component includes at least one surface having curvature.

[0688] According to one embodiment, the curved surface of the first spacing element is configured to face the surface of a recess in at least one of the first and second components. Points on the curved surface of the first spacing element are configured to abut against points on the surface of the recess.

[0689] According to one embodiment, when the first spacing element is positioned in a recess in at least one of the first and second components, the length by which the curved surface of the first spacing element abuts against the surface of the recess is less than half the length of the inclined surface of the first spacing element.

[0690] According to one embodiment, when a portion of the first spacing element is inserted into the recess, the length by which the curved surface of the first spacing element abuts against the surface of the recess is less than one-third of the length of the inclined surface of the first spacing element.

[0691] According to one embodiment, when a portion of the first spacing element is inserted into the recess, the length by which the curved surface of the first spacing element abuts against the surface of the recess is less than one-third of the length of the inclined surface of the first spacing element.

[0692] According to one embodiment, when a portion of the first spacing element is inserted into the recess, the length of contact between the curved surface of the first spacing element and the surface of the recess is less than half the depth of the recess, measured along a direction coinciding with the length axis of the first spacing element.

[0693] According to one embodiment, the portion of the first spacing element configured to enter the recess of the second component includes at least one surface having a first curvature and a second curvature extending in a vertical direction. The portion of the first spacing element configured to enter the recess of the second component may include at least one spherical surface.

[0694] According to one embodiment, at least one of the first and second components has a concave shape, such that when a portion of the first spacing element configured to enter the concave part of the first or second component is inserted into the concave part, two curved surfaces on opposite sides of the portion of the first spacing element configured to enter the concave part of the first or second component face two surfaces on opposite sides of the conical concave part.

[0695] According to one embodiment, the recess in at least one of the first component and the second component includes at least one surface having a curvature. The recess in at least one of the first component and the second component may include at least one surface having a first curvature and a second curvature extending in a vertical direction.

[0696] According to one embodiment, the recess in at least one of the first component and the second component includes at least one spherical surface.

[0697] According to one embodiment, the portion of the first spacing element configured to enter a recess in the first or second component includes at least one surface with a curvature having a first radius, and the recess in at least one of the first and second components includes at least one surface with a curvature having a second radius. According to one embodiment, the second radius is longer than the first radius.

[0698] According to one embodiment, the portion of the first spacing element configured to enter the recess of the first component or the second component includes at least one surface having a first curvature and a second curvature extending in a vertical direction.

[0699] According to one embodiment, the recess in at least one of the first component and the second component includes at least one surface having a first curvature and a second curvature extending in a vertical direction, and the sum of the radii of the first curvature and the second curvature of the recess in at least one of the first component and the second component is greater than the sum of the radii of the first curvature and the second curvature of the portion of the first spacing element configured to enter the recess.

[0700] According to one embodiment, the functional implantable medical device or the boundary of the functional implantable medical device may be elongated. The functional implantable medical device may be elongated, with the longest length being greater than 1.5 times the widest width.

[0701] According to one embodiment, the functional implantable medical device includes a curved portion, and the central axis of the curved portion of the functional implantable medical device follows the elongation of the functional implantable medical device.

[0702] According to one embodiment, a first portion of a functional implantable medical 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 tilted more than 5° relative to the patient's caudal-cranial axis.

[0703] According to one embodiment, the second portion of the curved central axis is configured to be positioned in the stomach and tilted toward the esophagus.

[0704] According to one embodiment, at least one of the first component and the second component has a shape corresponding to an ellipsoidal wedge or a truncated ellipsoidal wedge.

[0705] According to one embodiment, at least one of the first component and the second component has a shape corresponding to a spherical wedge or a truncated spherical wedge.

[0706] At least one of the first and second components may have a shape corresponding to a portion of an ellipsoidal wedge or a portion of a truncated ellipsoidal wedge.

[0707] According to one embodiment, at least one of the first and second components has a shape corresponding to a semi-ellipsoidal wedge or a truncated semi-ellipsoidal wedge.

[0708] At least one of the first and second components may have a shape corresponding to a portion of a spherical wedge or a portion of a truncated spherical wedge.

[0709] According to one embodiment, at least one of the first and second components has a shape corresponding to a hemispherical wedge or a truncated hemispherical wedge.

[0710] According to one embodiment, at least one of the first component and the second component has a shape corresponding to an ellipsoidal segment or a portion thereof.

[0711] According to one embodiment, at least one of the first component and the second component has a shape corresponding to a spherical segment or a portion thereof.

[0712] In any embodiment, the boundary of the functional motion restriction device or the functional implantable medical device may have a shape corresponding to an ellipsoid or a truncated ellipsoid.

[0713] 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.

[0714] According to one embodiment, at least the periphery of at least one of the first component and the second component has a shape corresponding to a cylinder.

[0715] According to one embodiment, the combined periphery of the first component and the second component has a shape corresponding to a cylinder.

[0716] According to one embodiment, the periphery of the first component has a shape corresponding to a first cylinder having a first radius, and the periphery of the second component has a shape corresponding to a second cylinder having a second radius, and the first radius and the second radius are different.

[0717] According to one embodiment, the functional implantable medical device or the boundary of the functional implantable medical device includes a stadium-shaped section or a truncated stadium-shaped section.

[0718] According to one embodiment, the functional implantable medical device includes a curved stadium-shaped section or a truncated curved stadium-shaped section.

[0719] According to one embodiment, the periphery of a first component has a shape corresponding to a cylindrical or ellipsoidal segment, and the periphery of a second component has a shape corresponding to a cylindrical or ellipsoidal segment. The first component includes at least one protrusion projecting from a first bottom surface, and the second component includes at least one recess on the first bottom surface. The at least one protrusion is adapted to be at least partially disposed in the at least one recess. The at least one protrusion may be adapted to engage with the at least one recess, and the first component may further include at least one recess on a second bottom surface.

[0720] The position of at least one protrusion may coincide with the position of at least one recess, such that when the first component is viewed along the normal direction of the first bottom surface, the recess and the protrusion overlap. The at least one recess may be recessed into the at least one protrusion.

[0721] According to one embodiment, at least one protrusion may be in the shape of a pyramid with a polygonal base.

[0722] According to one embodiment, the first component further includes at least one protrusion located on the second bottom surface, and the second component may further include at least one protrusion located on the second bottom surface. The second component may further include at least one recess located on the second bottom surface.

[0723] According to one embodiment, the implantable medical device further includes a third component, and the first component further includes a recess located on a second bottom surface, the second component further includes a protrusion projecting from the second bottom surface, and the third component includes a protrusion projecting from the first bottom surface and a recess located on the second bottom surface, the protrusion of the first component being configured to at least partially insert into the recess of the second component, the protrusion of the second component being configured to at least partially insert into the recess of the third component, and the first, second, and third components being configured to assemble to form at least a portion of a functional implantable medical device, wherein the recess and the protrusion stabilize the components relative to each other during assembly.

[0724] According to one embodiment, the area of ​​the first bottom surface of the first component is smaller than the area of ​​the first bottom surface of the second component.

[0725] According to one embodiment, at least one protrusion projecting from the first bottom surface of the first component includes a spacing element.

[0726] In any embodiment herein, a functional implantable medical device may include a surface friction-reducing coating covering at least a portion of the surface of the functional implantable medical device. The surface friction-reducing coating may be configured to reduce friction between the functional implantable medical device and the gastric wall tissue that at least partially encloses the functional implantable medical device.

[0727] The implantable medical device may further include a sensor configured to sense at least one of force and pressure for monitoring the pressure or force exerted by the medical device on the patient's stomach wall.

[0728] According to one embodiment, an implantable medical device includes a first portion and a second portion different from the first portion. The first portion has a first volume surrounded by a material of the implantable medical device, and the second portion has a second volume surrounded by a material of the implantable medical device. The first volume and the second volume can be of the same size, and the density of the first volume can be higher than that of the second volume, and the density of the second volume can be lower than 1000 kg / m³.

[0729] Further, an implantable medical device for treating reflux disease is provided. The implantable medical device includes a motion-limiting device configured to be fixed to the stomach wall to prevent movement of the lower esophageal sphincter relative to the diaphragm. The motion-limiting device includes a central component and at least two external components. The central component and at least two external components are configured to be connected to each other to form at least a portion of a functional motion-limiting device. The central component and at least two external components are disconnectable from each other, allowing each component to pass through the gastrointestinal tract independently. The outer surface of the functional motion-limiting device includes at least four flat surfaces spaced apart from each other by at least four curved surfaces, and the total area of ​​the at least four flat surfaces is in the range of 10% to 20% of the total surface area of ​​the functional motion-limiting device. According to one embodiment, the functional motion-limiting device includes at least five flat surfaces. According to one embodiment, the outer surface of the functional motion-limiting device includes at least six flat surfaces. According to one embodiment, the outer surface of the functional motion-limiting device includes at least seven flat surfaces. According to one embodiment, the outer surface of the functional motion-limiting device includes at least eight flat surfaces.

[0730] In any embodiment, the flat surface may be elliptical, circular, or polygonal.

[0731] Further, an implantable medical device for treating reflux disease is provided. The implantable medical device includes a motion restriction device configured to be fixed to the stomach wall to prevent movement of the lower esophageal sphincter relative to the diaphragm. The motion restriction device includes a central component and at least two external components. The central component and at least two external components are configured to be connected to each other to form at least a portion of a functional motion restriction device. The central component and at least two external components are detachable from each other, allowing the central component and at least two external components to pass through the gastrointestinal tract independently. According to one embodiment, the volume of at least one of the functional motion restriction device and its boundary is 10 cm². 3 Up to 30cm 3 Within the range; and according to another embodiment, the volume of the functional motion restriction device or the boundary of the functional motion restriction device is within 12cm. 3 Up to 25cm 3 Within the range; and according to another embodiment, the volume of the functional motion restriction device or the boundary of the functional motion restriction device is within 15cm. 3 Up to 25cm 3 Within the range; and according to another embodiment, the volume of the functional motion restriction device or the boundary of the functional motion restriction device is within 15cm. 3 Up to 22cm 3 Within the range.

[0732] Further, an implantable medical device for treating reflux disease is provided. The implantable medical device includes a motion restriction device configured to be fixed to the stomach wall to prevent movement of the lower esophageal sphincter relative to the diaphragm. The motion restriction device includes at least two components configured to connect with each other to form at least a portion of a functional motion restriction device, and the at least two components are disconnectable from each other, allowing each component to pass through the gastrointestinal tract independently. The height of the functional motion restriction device is in the range of 1 inch to 3.5 cm, or 3 cm to 6 cm, or 3 cm to 5 cm, or 3.5 cm to 6 cm, or 4 cm to 5 cm, or 4 cm to 6 cm.

[0733] The implantable medical device may further include a central component, and the at least two components may be configured to connect with the central component to form at least a portion of a functional movement restriction device. The central component and the at least two components may be disconnected from each other, allowing the central component and the at least two components to pass through the gastrointestinal tract independently.

[0734] Further, an implantable medical device for treating reflux disease is provided. The implantable medical device includes a motion-limiting device configured to be fixed to the stomach wall to prevent movement of the lower esophageal sphincter relative to the diaphragm. The motion-limiting device includes a central component and at least two external components. The central component and at least two external components are configured to be connected to each other to form at least a portion of a functional motion-limiting device. The central component and at least two external components are disconnectable from each other, allowing the central component and at least two external components to pass through the gastrointestinal tract individually. At least one of the two external components includes a wedge-shaped portion, and the central component also includes a wedge-shaped portion. The wedge-shaped portion of at least one external component is configured to be disposed within the wedge-shaped portion of the central component, and the wedge-shaped portion of at least one external component is wedge-shaped with a first angle. The wedge-shaped portion of the central component is wedge-shaped with a second angle, wherein the first angle is greater than the second angle by at least 7°. According to one embodiment, the first angle is greater than the second angle by at least 10°; and according to another embodiment, the first angle is greater than the second angle by at least 12°; and according to yet another embodiment, the first angle is greater than the second angle by at least 15°. At least one external component may include a wedge-shaped recess configured to engage with a wedge-shaped protrusion of the central component, or at least one external component may include a wedge-shaped protrusion configured to engage with a wedge-shaped recess of the central component. The wedge-shaped portion of the central component may include a wedge-shaped recess or a wedge-shaped protrusion.

[0735] Further, an implantable medical device for treating reflux disease is provided. The implantable medical device includes a motion-limiting device configured to be fixed to the stomach wall to prevent movement of the lower esophageal sphincter relative to the diaphragm. The motion-limiting device includes a central component and at least two external components. The central component and at least two external components are configured to be connected to each other to form at least a portion of a functional motion-limiting device. The central component and at least two external components are disconnectable from each other, allowing the central component and at least two external components to pass through the gastrointestinal tract independently. At least one of the two external components includes a wedge-shaped portion, and the central component includes a wedge-shaped portion. The wedge-shaped portion of the central component is configured to be disposed within the wedge-shaped portion of the central component, and the wedge-shaped portion of at least one external component has a wedge shape having a first angle, and the wedge-shaped portion of the central component has a wedge shape having a second angle, wherein the second angle is greater than the first angle by at least 7°. According to one embodiment, the second angle is greater than the first angle by at least 10°; and according to another embodiment, the second angle is greater than the first angle by at least 12°; and according to yet another embodiment, the second angle is greater than the first angle by at least 15°.

[0736] At least one external component may have a wedge-shaped recess or a wedge-shaped protrusion. The central component may have a wedge-shaped recess or a wedge-shaped protrusion.

[0737] Further, an implantable medical device for treating reflux disease is provided. The implantable medical device includes a motion-limiting device configured to be fixed to the stomach wall to prevent movement of the lower esophageal sphincter relative to the diaphragm. The motion-limiting device includes a central component and at least two external components. The central component and at least two external components are configured to connect with each other to form at least a portion of a functional motion-limiting device. The central component and at least two external components are disconnectable from each other, allowing the central component and at least two external components to pass through the gastrointestinal tract independently. At least one of the two external components includes a contact surface configured to contact a contact surface of the central component, and at least one of the contact surfaces of at least one external component and the central component is curved.

[0738] According to one embodiment, the contact surface of at least one external component and the contact surface of the central component are convex.

[0739] According to one embodiment, at least one of the contact surface of at least one external component and the contact surface of the central component is concave.

[0740] According to one embodiment, at least one of the contact surfaces of at least an external component and the contact surface of a central component includes an elliptical point.

[0741] According to one embodiment, the area of ​​contact between the contact surface of at least one external component and the contact surface of the central component is less than half the area of ​​the contact surface of at least one external component.

[0742] According to one embodiment, the area of ​​contact between the contact surface of at least one external component and the contact surface of the central component is less than one-third of the area of ​​the contact surface of at least one external component.

[0743] Further, an implantable medical device for treating reflux disease is provided. The implantable medical device includes a motion-limiting device configured to be fixed to the stomach wall to prevent movement of the lower esophageal sphincter relative to the diaphragm. The motion-limiting device includes a central component and at least two external components. The central component and at least two external components are configured to connect with each other to form at least a portion of a functional motion-limiting device. The central component and at least two external components are disconnectable from each other, allowing each component to pass through the gastrointestinal tract independently. The central component includes at least three spaced-apart vertically extending edges, each having at least one contact surface configured to contact at least one surface of the at least two external components. At least a portion of the at least three vertically extending edges is wedge-shaped with an angle ranging from 20° to 60°.

[0744] According to one embodiment, a portion of at least three vertically extending edges forms a wedge shape with an angle exceeding 25°.

[0745] According to one embodiment, a portion of at least three vertically extending edges forms a wedge shape with an angle exceeding 30°.

[0746] According to one embodiment, a portion of at least three vertically extending edges forms a wedge shape with an angle exceeding 35°.

[0747] At least one wedge-shaped portion with a vertically extending edge may taper gradually in a direction away from the center of gravity of the central component.

[0748] According to one embodiment, the vertically extending edge has an elongated wedge-shaped portion, wherein the elongated wedge-shaped portion of the vertically extending edge gradually tapers along the elongation direction of the vertically extending edge.

[0749] The implantable medical device may further include at least one horizontally extending edge that extends substantially vertically from at least one of the vertically extending edges, and the horizontally extending edge may include a wedge-shaped portion. The wedge-shaped portion of the horizontally extending edge may taper gradually in a direction away from the center of gravity of the central component.

[0750] According to one embodiment, the wedge-shaped portion of the horizontally extending edge is wedge-shaped with an angle ranging from 20° to 60°.

[0751] Further, an implantable medical device for treating reflux disease is provided. The implantable medical device includes a motion-limiting device configured to be fixed to the stomach wall to prevent movement of the lower esophageal sphincter relative to the diaphragm. The motion-limiting device includes a central component and at least two external components. The central component and at least two external components are configured to connect with each other to form at least a portion of a functional motion-limiting device. The central component and at least two external components are disconnectable from each other, allowing the central component and at least two external components to pass through the gastrointestinal tract independently. The central component includes at least one horizontally extending edge extending in a direction perpendicular to a vertical plane, wherein the central component has at least one contact surface configured to contact at least one surface of the at least two external components. A portion of the horizontally extending edge is wedge-shaped with an angle ranging from 20° to 60°.

[0752] According to one embodiment, a portion of the horizontally extending edge is wedge-shaped with an angle exceeding 25°, or an angle exceeding 30°, or an angle exceeding 35°.

[0753] According to one embodiment, the wedge-shaped portion of the horizontally extending edge gradually tapers in a direction away from the center of gravity of the central component.

[0754] According to one embodiment, the implantable medical device further includes at least two vertically extending edges that extend substantially vertically from the horizontally extending edge.

[0755] According to one embodiment, the vertically extending edge includes a wedge-shaped portion.

[0756] According to one embodiment, the wedge-shaped portion of the vertically extending edge gradually tapers in a direction away from the center of gravity of the central component.

[0757] According to one embodiment, the wedge-shaped portion of the vertically extending edge is wedge-shaped with an angle ranging from 20° to 60°.

[0758] Further, an implantable medical device for treating reflux disease is provided. The implantable medical device includes a motion-limiting device configured to be fixed to the stomach wall to prevent movement of the lower esophageal sphincter relative to the diaphragm. The motion-limiting device includes a central component and at least two external components. The central component and at least two external components are configured to be connected to each other to form at least a portion of a functional motion-limiting device. The central component and at least two external components are disconnectable from each other, allowing each component to pass through the gastrointestinal tract independently. The mass of the central component exceeds the mass of at least one of the external components.

[0759] According to one embodiment, the mass of the central component exceeds the mass of at least one of the outer components by at least 10%.

[0760] According to one embodiment, the mass of the central component exceeds the mass of at least one of the outer components by at least 20%.

[0761] According to one embodiment, the mass of the central component exceeds the mass of at least one of the outer components by at least 30%.

[0762] According to one embodiment, the volume of the central component exceeds the volume of at least one of the outer components by at least 10%.

[0763] According to one embodiment, the volume of the central component exceeds the volume of at least one of the outer components by at least 20%.

[0764] According to one embodiment, the volume of the central component exceeds the volume of at least one of the outer components by at least 30%.

[0765] Further, an implantable medical device for treating reflux disease is provided. The implantable medical device includes a motion-limiting device configured to be fixed to the stomach wall to prevent movement of the lower esophageal sphincter relative to the diaphragm. The motion-limiting device includes a central component and at least two external components. The central component and at least two external components are configured to be connected to each other to form at least a portion of a functional motion-limiting device. The central component and at least two external components are disconnectable from each other, allowing each component to pass through the gastrointestinal tract independently. The longest cross-sectional distance of at least one of the external components exceeds the longest cross-sectional distance of the central component by at least 20%.

[0766] According to one embodiment, the longest cross-sectional distance of at least one of the outer components exceeds the longest cross-sectional distance of the central component by at least 30%.

[0767] According to one embodiment, the longest cross-sectional distance of at least one of the outer components exceeds the longest cross-sectional distance of the central component by at least 40%.

[0768] According to one embodiment, the longest cross-sectional distance of at least one of the outer components exceeds the longest cross-sectional distance of the central component by at least 50%.

[0769] Furthermore, an implantable medical device for treating reflux disease is provided, the implantable medical device including a motion restriction device configured to be fixed to the stomach wall to prevent movement of the lower esophageal sphincter relative to the diaphragm.

[0770] According to one embodiment, at least one of the motion restriction device and the boundary of the motion restriction device has a surface area of ​​1 cm². 2 Up to 25cm 2 Within the range, or within 1.5cm 2 Up to 22.5cm 2Within the range, or within 1.5cm 2 up to 20.5cm 2 Within the range, or >10.5cm 2 Up to 20.9cm 2 Within the range, or within 12cm 2 Up to 19cm 2 Within the range, or within 13cm 2 Up to 19cm 2 Within the range, or within 13cm 2 Up to 18cm 2 Within the range.

[0771] According to one embodiment, the motion limiting device is elongated and has a height (longest cross-sectional distance) and a width (longest cross-sectional distance perpendicular to the height), wherein the height is 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.

[0772] According to one embodiment, the height of the motion restriction device is in the range of 5.5mm to 24.5mm, or in the range of 0.5cm to 1 inch, or in the range of 1.55cm to 2.45cm, or in the range of 0.55cm to 2.45cm.

[0773] According to one embodiment, the volume of at least one of the motion limiting device and the boundary of the motion limiting device is 0.3 cm. 3 Up to 6.6cm 3 Within the range, or within 0.5cm 3 Up to 7.3cm 3 Within the range, or 3cm 3 Up to 8cm 3 Within the range, or within 2.5cm 3 Up to 6.6cm 3 Within the range, or within 4cm 3 Up to 7.3cm 3 Within the range.

[0774] The present invention also provides an implantable medical device for treating reflux disease, the implantable medical device comprising a motion restriction device configured to be fixed to the stomach wall to prevent movement of the lower esophageal sphincter relative to the diaphragm. The motion restriction device includes at least two components configured to be connected to each other to form at least a portion of a functional motion restriction device, and the at least two components are detachable from each other, allowing the at least two components to pass through the gastrointestinal tract independently. The surface area of ​​at least one of the functional motion restriction device and its boundary is 1 cm². 2 Up to 25cm 2 Within the range, or within 1.5cm 2 Up to 22.5cm 2 Within the range, or within 1.5cm 2 up to 20.5cm 2 Within the range, or >10.5cm 2 Up to 20.9cm 2 Within the range, or within 12cm 2 Up to 19cm 2 Within the range, or within 13cm 2 Up to 19cm 2 Within the range, or within 13cm 2 Up to 18cm 2 Within the range.

[0775] According to one embodiment, the functional motion limiting device is elongated and has a height (longest cross-sectional distance) and a width (longest cross-sectional distance perpendicular to the height), wherein the height is 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.

[0776] According to one embodiment, the height of the motion restriction device is in the range of 5.5mm to 24.5mm, or in the range of 0.5cm to 1 inch, or in the range of 1.55cm to 2.45cm, or in the range of 0.55cm to 2.45cm.

[0777] According to one embodiment, the implantable medical device further includes a central component, and the at least two components are configured to connect with the central component to form at least a portion of a functional movement restriction device. The central component and the at least two components are disconnectable from each other, allowing the central component and the at least two components to pass through the gastrointestinal tract independently.

[0778] Further, an implantable medical device for treating reflux disease is provided. The implantable medical device includes a motion-limiting device configured to be fixed to the stomach wall to prevent movement of the lower esophageal sphincter relative to the diaphragm. The motion-limiting device includes at least two components configured to connect with each other to form at least a portion of a functional motion-limiting device. The at least two components are disconnectable from each other, allowing each component to pass through the gastrointestinal tract independently. The functional motion-limiting device is elongated and has a height (longest cross-sectional distance) and a width (longest cross-sectional distance perpendicular to the height), wherein the height is 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.

[0779] According to one embodiment, the height of the functional motion restriction device is in the range of 5.5mm to 24.5mm, or in the range of 0.5cm to 1 inch, or in the range of 1.55cm to 2.45cm, or in the range of 0.55cm to 2.45cm.

[0780] The implantable medical device may further include a central component, and the at least two components may be configured to connect with the central component to form at least a portion of a functional movement restriction device. The central component and the at least two components may be disconnected from each other, allowing the central component and the at least two components to pass through the gastrointestinal tract independently.

[0781] A further surgical method for treating reflux disease is provided. The surgical method includes the following steps: dissecting the gastric fundus at least partially posteriorly in a direction generally toward the omental bursa and away from the spleen; dissecting the esophagus such that it is severed from the surrounding tissues at least 3 cm cranially from the His angle; and connecting the gastric fundus to the esophagus by inserting at least two posterior single sutures or staples or using a single continuous suture along the posterior suture line on the left posterolateral side of the esophagus, thereby connecting the gastric fundus to the esophagus; and by inserting at least two anterior sutures or staples or using a single continuous suture along the anterior suture line on the left anterior side of the esophagus, thereby connecting the gastric fundus to the esophagus. The surgical method further includes the following step: placing an implantable motion-limiting device in the gastric fundus between the His angle and the diaphragm to prevent the lower esophageal sphincter from sliding through the esophageal hiatus.

[0782] According to one embodiment, a surgical method for at least partially separating the fundus of the stomach posteriorly includes the steps of: at least partially detaching the fundus of the stomach from at least one of the gastrodiaphragmatic ligament and the gastrosplenic ligament. The step of at least partially separating the fundus of the stomach posteriorly may include: separating the fundus at least 0.5 cm posterior to the coronal plane intersecting the point closest to the cranial side of the fundus, or at least 1 cm posterior to the coronal plane intersecting the point closest to the cranial side of the fundus.

[0783] According to one embodiment, the surgical procedure for separating the gastric fundus further includes: separating short gastric vessels and ligating at least one of them.

[0784] According to one embodiment, the surgical procedure for separating the gastric fundus further includes: separating short gastric vessels (gastric brevis / short gastrics) and ligating at least two of them.

[0785] According to one embodiment, the surgical procedure for separating the gastric fundus further includes: separating short gastric vessels (gastric brevis / short gastrics) and ligating at least three of them.

[0786] According to one embodiment, the surgical procedure of separating the fundus of the stomach at least partially on its posterior side may include separating the fundus at least 0.5 cm posterior to the anterior fixation point of the gastrodiaphragmatic ligament on the fundus, or at least 1 cm posterior to the anterior fixation point of the gastrodiaphragmatic ligament on the fundus.

[0787] According to one embodiment, the surgical procedure of separating the gastric fundus at least partially behind its posterior side may include separating the gastric fundus at least 0.5 cm behind the greater curvature extension in the gastric fundus region, or at least 1 cm behind the greater curvature extension in the gastric fundus region.

[0788] According to one embodiment, the surgical method for separating the esophagus includes the following steps: separating the esophagus such that it is severed from the surrounding tissue at least 4 cm from the His angle along the cranial direction, preferably at least 5 cm from the His angle along the cranial direction, and most preferably at least 6 cm from the His angle along the cranial direction.

[0789] According to one embodiment, a surgical method for separating the esophagus to sever it from surrounding tissues includes separating the esophagus into the mediastinum. The step of separating the esophagus into the mediastinum may include: separating the esophagus into the mediastinum such that the esophagus is severed from surrounding tissues at least 1 cm from the distal edge of the esophageal hiatus along a cranial direction, preferably at least 2 cm from the distal edge of the esophageal hiatus along a cranial direction, and most preferably at least 3 cm from the distal edge of the esophageal hiatus along a cranial direction.

[0790] According to one embodiment, the step of separating the esophagus into the mediastinum includes: separating the esophagus into the mediastinum such that the esophagus and surrounding tissue are severed along the cranial side from the distal edge of the repaired esophageal hiatus to provide at least 4 cm of abdominal esophagus, preferably severed from the distal edge of the repaired esophageal hiatus to provide at least 5 cm of abdominal esophagus, and most preferably providing at least 6 cm of abdominal esophagus.

[0791] According to one embodiment, the step of separating the esophagus to isolate it from surrounding tissues includes: identifying the anterior and posterior vagal nerve trunks to avoid the risk of nerve damage.

[0792] According to one embodiment, the step of separating the esophagus into the mediastinum includes: separating the esophagus distally from a point 2 cm away from the vagus esophageal plexus, preferably from a point 1 cm away from the vagus esophageal plexus, and more preferably from a point 0.5 cm away from the vagus esophageal plexus.

[0793] According to one embodiment, the step of separating the esophagus includes detaching the esophagus from the crus of the diaphragm.

[0794] According to one embodiment, a surgical method for connecting the fundus of the stomach to the esophagus by inserting at least two posterior sutures or anastomotic staples on the left posterolateral side of the esophagus includes: inserting at least two continuous sutures on the left posterolateral side of the esophagus to connect the fundus of the stomach to the esophagus.

[0795] According to one embodiment, a surgical method for connecting the fundus of the stomach to the esophagus by inserting at least two anterior sutures or anastomotic staples on the left anterior side of the esophagus includes: inserting at least two continuous sutures on the left anterior side of the esophagus to connect the fundus of the stomach to the esophagus.

[0796] In any embodiment herein, at least one of the beginning and end of a continuous suture may be performed in the serosa of the stomach wall to secure the suture to the serosa of the stomach wall.

[0797] According to one embodiment, the surgical procedure of connecting the fundus of the stomach to the esophagus by inserting at least two posterior sutures or anastomotic staples on the left posterolateral side of the esophagus includes: inserting at least two lateral sutures substantially along the craniococcygeal axis on the left posterolateral side of the esophagus.

[0798] According to one embodiment, the surgical procedure of connecting the fundus of the stomach to the esophagus by inserting at least two anterior sutures or anastomotic staples on the left anterior side of the esophagus includes: inserting at least two lateral sutures substantially along the craniococcygeal axis on the left anterior side of the esophagus.

[0799] According to one embodiment, the surgical procedure of connecting the fundus of the stomach to the esophagus by inserting at least two posterior sutures or anastomotic staples on the left posterolateral side of the esophagus includes: inserting at least two posterior sutures or anastomotic staples at least 0.5 cm posterior to the coronal plane at the point where the fundus of the stomach is closest to the cranial side.

[0800] According to one embodiment, the surgical procedure of connecting the fundus of the stomach to the esophagus by inserting at least two anterior sutures or anastomotic staples on the left anterior side of the esophagus includes: inserting at least two anterior sutures or anastomotic staples at least 0.5 cm anterior to the coronal plane at the point where the fundus of the stomach is closest to the cranial side.

[0801] According to one embodiment, the surgical procedure of connecting the gastric fundus to the esophagus by inserting at least two posterior sutures or anastomotic staples on the left posterolateral side of the esophagus includes: inserting the most posterior suture or anastomotic staple at least 0.5 cm from the His angle.

[0802] According to one embodiment, the surgical procedure of connecting the fundus of the stomach to the esophagus by inserting at least two anterior sutures or anastomoses on the left anterior side of the esophagus includes: inserting the caudal suture or anastomose at least 0.5 cm from the His angle.

[0803] According to one embodiment, the step of placing at least two posterior sutures on the left posterolateral side of the esophagus to connect the fundus of the stomach to the esophagus includes placing a caudal suture, and the step of placing at least two anterior sutures on the left anterior side of the esophagus to connect the fundus of the stomach to the esophagus includes placing a caudal suture, including placing at least one caudal suture in the His angle region.

[0804] According to one embodiment, the step of placing at least two posterior sutures on the left posterolateral side of the esophagus to connect the fundus of the stomach to the esophagus includes placing a caudal suture, and the step of placing at least two anterior sutures on the left anterior side of the esophagus to connect the fundus of the stomach to the esophagus includes placing a caudal suture, including placing at least one of the two caudal sutures in a region at least 1.5 cm above the His angle.

[0805] According to one embodiment, the surgical procedure of connecting the gastric fundus to the esophagus by inserting at least two posterior sutures or anastomotic staples on the left posterolateral side of the esophagus includes: inserting the most posterior suture or anastomotic staple at least 1.5 cm from the His angle.

[0806] According to one embodiment, the surgical procedure of connecting the gastric fundus to the esophagus by inserting at least two anterior sutures or anastomoses on the left anterior side of the esophagus includes: inserting the caudal suture or anastomose at least 1.5 cm from the His angle.

[0807] According to one embodiment, the surgical method includes the following steps: inserting at least two posterior sutures or anastomoses at least 0.5 cm from the His angle on the left posterolateral side of the esophagus to connect the fundus of the stomach to the esophagus, and inserting at least two anterior sutures or anastomoses at least 1.5 cm from the His angle on the left anterior side of the esophagus to connect the fundus of the stomach to the esophagus.

[0808] According to one embodiment, the surgical method includes the following steps: inserting at least two posterior sutures or anastomoses at least 1.5 cm from the His angle on the left posterolateral side of the esophagus to connect the fundus of the stomach to the esophagus, and inserting at least two anterior sutures or anastomoses at least 0.5 cm from the His angle on the left anterior side of the esophagus to connect the fundus of the stomach to the esophagus.

[0809] According to one embodiment, the surgical method for connecting the gastric fundus to the esophagus further includes: inserting at least one central suture or anastomotic staple along a craniotail axis extending between at least two posterior sutures or anastomotic staples or a continuous suture and at least two anterior sutures or anastomotic staples or a continuous suture. At least one suture is inserted at the position closest to the cranial side, preferably a row of sutures between the posterior and anterior sutures, and sutures are inserted 1 cm from both the anterior and posterior sutures around the periphery of the esophagus.

[0810] According to one embodiment, the step of connecting the gastric fundus to the esophagus further includes: inserting at least one central suture along a cranio-coccygeal axis extending between at least two posterior sutures or one continuous suture and at least two anterior sutures or one continuous suture; inserting a third continuous suture between the posterior and anterior sutures; and inserting a suture at a target distance of 1 cm from the anterior and posterior sutures around the periphery of the esophagus.

[0811] The step of inserting at least one central suture or anastomotic staple along the cranio-coccygeal axis may include: inserting at least one central intervening suture or anastomotic staple, which is separate from at least two anterior sutures or anastomotic staples and at least two posterior sutures or anastomotic staples, in order to maintain the possibility of radial dilatation of the esophagus to limit the risk of dysphagia.

[0812] According to one embodiment, the surgical procedure of connecting the fundus of the stomach to the esophagus by inserting at least two posterior sutures or anastomotic staples or one continuous suture on the left posterolateral side of the esophagus, and connecting the fundus of the stomach to the esophagus by inserting at least two anterior sutures or one continuous suture or anastomotic staple on the left anterior side of the esophagus, includes the use of sutures with at least partial barbs.

[0813] In any of the surgical methods described herein, the step of stabilizing the implantable motion restriction device to the fundus of the stomach may include: inserting a series of multi-point / purse-string sutures in the greater curvature region of the fundus, such that during implantation, pulling the end of the purse-string suture causes the gastric tissue to contract and form a cap-like structure above the implantable motion restriction device. The step of inserting the top suture may include: inserting at least one continuous purse-string top suture at least 1 cm, preferably 2 cm, posterior to the greater curvature in the caudal region of the fundus.

[0814] According to one embodiment, the step of inserting a continuous purse top suture may include: inserting the continuous purse top suture by using at least partially barbed sutures, leaving a loose suture loop.

[0815] According to one embodiment, the surgical procedure for inserting a continuous purse-string top suture may include: starting or ending the continuous purse-string top suture at least 1 cm from the anterior suture from the esophagus to the stomach.

[0816] According to one embodiment, the surgical procedure for inserting a continuous purse-string top suture may include: inserting a continuous purse-string top suture using a suture with a loop at the end and no barbs near the loop, such that the suture can be pulled through the loop to contract the gastric tissue, while simultaneously keeping the loop in a relaxed state.

[0817] In any of the surgical methods described herein, the step of securing an implantable motion-limiting device to the fundus of the stomach may include: inserting the implantable motion-limiting device into the patient's abdomen. The step of inserting the implantable motion-limiting device into the patient's abdomen may include: inserting the implantable motion-limiting device into the patient's abdomen using an insertion instrument having an elongated abdominal portion.

[0818] According to one embodiment, a surgical method for securing an implantable motion restriction device to the fundus of the stomach may include: using an instrument with an elongated abdominal portion to push the implantable motion restriction device into the fundus of the stomach along the cranial direction. The step of using an instrument with an elongated abdominal portion to push the implantable motion restriction device into the fundus of the stomach along the dorsal-cranial direction may include: using an elongated insertion instrument to push the implantable motion restriction device so that a portion of the implantable motion restriction device is ultimately located on the dorsal side of the top suture, thereby forming a cap-like structure for placing the motion restriction device into the fundus to facilitate subsequent encapsulation of the high portion of the fundus.

[0819] According to one embodiment, the step of securing an implantable motion restriction device to the fundus of the stomach includes: inserting continuous purse-string base or bottom sutures in a region below the motion restriction device or near the fundus / near a position of the elongated insertion device to maintain the implantable motion restriction device in a stable position. The step of inserting continuous purse-string bottom sutures in the tail region of the implantable motion restriction device may include: inserting at least two of the continuous purse-string bottom suture entry points along an arc, preferably from the patient's left to right side, around the motion restriction device at least from the midline to the midline in an arc, to stabilize the position of the motion restriction device. When at least two continuous purse-string bottom sutures are inserted along an arc, the continuous purse-string bottom sutures can be inserted along an arc below the elongated abdominal portion of the device to maintain the implantable motion restriction device.

[0820] According to one embodiment, the step of inserting a continuous purse-string base or bottom suture in the tail region of an implantable motion restriction device may include: inserting the continuous purse-string base suture such that the needle entry point of the continuous purse-string base suture forms a closed curve or a closed loop, so that the stomach contacts each other above the device from the left and right sides of the elongated insertion device.

[0821] According to one embodiment, the step of stabilizing an implantable motion restriction device relative to the gastric fundus may include: inserting at least one suture or staple around the motion restriction device and around an elongated insertable instrument from the gastric wall to close the suture loop above the elongated abdominal portion of the instrument, thereby retaining the implantable motion restriction device.

[0822] According to one embodiment, the step of inserting a continuous purse-string base suture in the tail region of an implantable motion restriction device may include: inserting one of the continuous purse-string base sutures from the stomach wall to the stomach wall above the elongated abdominal portion of the device, thereby retaining the implantable motion restriction device.

[0823] The steps of securing an implantable motion restriction device to the fundus of the stomach may include: releasing the elongated abdominal portion of the device from the implantable motion restriction device.

[0824] According to one embodiment, the step of stabilizing an implantable motion-limiting device to the fundus of the stomach may include: inserting at least one suture or staple to close an opening in the area where the elongated abdominal portion of the device is removed from the stomach wall, and to close a hole through which the elongated abdominal portion of the device passes.

[0825] According to one embodiment, the step of suturing a continuous purse-string base suture may include: inserting the continuous purse-string base suture using at least barbless sutures so that the stomach wall can contract and relax during the surgical procedure.

[0826] According to one embodiment, the step of stabilizing an implantable motion restriction device in the gastric fundus includes: contracting a first portion of the gastric wall by pulling the top suture of the purse-string suture, and contracting a second portion of the gastric wall by pulling the base suture of the purse-string suture. Thus, the implantable motion restriction device can be secured in the gastric wall between the first and second contracting portions.

[0827] The surgical method according to any one of the foregoing embodiments may further include the following steps: securing the implantable motion restriction device to the gastric fundus by wrapping the remaining uncovered implantable motion restriction device from the outside of the gastric fundus wall into the gastric fundus wall and suturing from tail to head with a single suture or continuous suture. The step of wrapping the implantable motion restriction device from the outside of the gastric fundus wall into the gastric fundus wall may include: inserting at least two sutures or staples from the gastric wall to the gastric wall to connect the gastric wall to the gastric wall around the implantable motion restriction device, thereby encapsulating the implantable motion restriction device in a pouch formed by the gastric wall of the gastric fundus. The step of wrapping the implantable motion restriction device may include: concluding the wrapping by fixing the sutures to the serosa of the gastric wall for long-term fixation.

[0828] According to one embodiment, the step of securing an implantable motion restriction device to the fundus of the stomach includes: contracting a first portion of the stomach wall by pulling on the top purse suture, and determining the length of the loop formed by the top purse suture by securing the top purse suture to the serosa of the stomach wall.

[0829] A further surgical method for treating reflux disease is provided. The surgical method includes the following steps: connecting the gastric fundus to the esophagus by inserting at least two lateral posterior sutures or anastomotic staples or at least one continuous suture substantially along the craniococcygeal axis on the left posterolateral side of the esophagus, thereby connecting the gastric fundus to the esophagus on the left posterolateral side; and inserting at least two lateral anterior sutures or anastomotic staples or at least one continuous suture substantially along the craniococcygeal axis on the left posterolateral side of the esophagus, thereby connecting the gastric fundus to the esophagus on the left posterolateral side or on the left side of the esophagus. The surgical method further includes the following step: stabilizing an implantable motion-limiting device to the gastric fundus to prevent the lower esophageal sphincter from sliding through the esophageal hiatus.

[0830] According to one embodiment, a surgical method for connecting the fundus of the stomach to the esophagus by inserting at least two posterior sutures or anastomotic staples on the left posterolateral side of the esophagus includes: inserting at least two continuous sutures on the left posterolateral side of the esophagus to connect the fundus of the stomach to the esophagus.

[0831] According to one embodiment, a surgical method for connecting the fundus of the stomach to the esophagus by inserting at least two anterior sutures or anastomotic staples on the left anterior side of the esophagus includes: inserting at least two continuous sutures on the left anterior side of the esophagus to connect the fundus of the stomach to the esophagus.

[0832] In any embodiment herein, at least one of the beginning and end of a continuous suture may be performed in the serosa of the stomach wall to secure the suture to the serosa of the stomach wall.

[0833] According to one embodiment, the surgical procedure of connecting the fundus of the stomach to the esophagus by inserting at least two posterior sutures or anastomotic staples on the left posterolateral side of the esophagus includes: inserting at least two lateral sutures substantially along the craniococcygeal axis on the left posterolateral side of the esophagus.

[0834] According to one embodiment, the surgical procedure of connecting the fundus of the stomach to the esophagus by inserting at least two anterior sutures or anastomotic staples on the left anterior side of the esophagus includes: inserting at least two lateral sutures substantially along the craniococcygeal axis on the left anterior side of the esophagus.

[0835] According to one embodiment, the surgical procedure of connecting the fundus of the stomach to the esophagus by inserting at least two posterior sutures or anastomotic staples on the left posterolateral side of the esophagus includes: inserting at least two posterior sutures or anastomotic staples at least 0.5 cm posterior to the coronal plane at the point where the fundus of the stomach is closest to the cranial side.

[0836] According to one embodiment, the surgical procedure of connecting the fundus of the stomach to the esophagus by inserting at least two anterior sutures or anastomotic staples on the left anterior side of the esophagus includes: inserting at least two anterior sutures or anastomotic staples at least 0.5 cm anterior to the coronal plane at the point where the fundus of the stomach is closest to the cranial side.

[0837] According to one embodiment, the surgical procedure of connecting the gastric fundus to the esophagus by inserting at least two posterior sutures or anastomotic staples on the left posterolateral side of the esophagus includes: inserting the most posterior suture or anastomotic staple at least 0.5 cm from the His angle.

[0838] According to one embodiment, the surgical procedure of connecting the fundus of the stomach to the esophagus by inserting at least two anterior sutures or anastomoses on the left anterior side of the esophagus includes: inserting the caudal suture or anastomose at least 0.5 cm from the His angle.

[0839] According to one embodiment, the step of placing at least two posterior sutures on the left posterolateral side of the esophagus to connect the fundus of the stomach to the esophagus includes placing a caudal suture, and the step of placing at least two anterior sutures on the left anterior side of the esophagus to connect the fundus of the stomach to the esophagus includes placing a caudal suture, including placing at least one caudal suture in the His angle region.

[0840] According to one embodiment, the step of placing at least two posterior sutures on the left posterolateral side of the esophagus to connect the fundus of the stomach to the esophagus includes placing a caudal suture, and the step of placing at least two anterior sutures on the left anterior side of the esophagus to connect the fundus of the stomach to the esophagus includes placing a caudal suture, including placing at least one of the two caudal sutures in a region at least 1.5 cm above the His angle.

[0841] According to one embodiment, the surgical procedure of connecting the gastric fundus to the esophagus by inserting at least two posterior sutures or anastomotic staples on the left posterolateral side of the esophagus includes: inserting the most posterior suture or anastomotic staple at least 1.5 cm from the His angle.

[0842] According to one embodiment, the surgical procedure of connecting the gastric fundus to the esophagus by inserting at least two anterior sutures or anastomoses on the left anterior side of the esophagus includes: inserting the caudal suture or anastomose at least 1.5 cm from the His angle.

[0843] According to one embodiment, the surgical method includes the following steps: inserting at least two posterior sutures or anastomoses at least 0.5 cm from the His angle on the left posterolateral side of the esophagus to connect the fundus of the stomach to the esophagus, and inserting at least two anterior sutures or anastomoses at least 1.5 cm from the His angle on the left anterior side of the esophagus to connect the fundus of the stomach to the esophagus.

[0844] According to one embodiment, the surgical method includes the following steps: inserting at least two posterior sutures or anastomoses at least 1.5 cm from the His angle on the left posterolateral side of the esophagus to connect the fundus of the stomach to the esophagus, and inserting at least two anterior sutures or anastomoses at least 0.5 cm from the His angle on the left anterior side of the esophagus to connect the fundus of the stomach to the esophagus.

[0845] According to one embodiment, the surgical method for connecting the gastric fundus to the esophagus further includes: inserting at least one central suture or anastomotic staple along a cranio-coccygeal axis extending between at least two posterior sutures or one continuous suture and at least two anterior sutures or anastomotic staples or one continuous suture; inserting at least one suture at the position closest to the cranial side, preferably a row of sutures between the posterior and anterior sutures; and inserting sutures 1 cm away from both the anterior and posterior sutu...

Claims

1. A surgical kit for performing surgical procedures to treat reflux disease, the surgical kit comprising: An implantable motion-limiting device configured to prevent movement of the lower esophageal sphincter relative to the diaphragm, and at least partially positioned between the His angle and the diaphragm. A lubricant containing at least one antibacterial substance is used in conjunction with the implantable motion restriction device. At least one absorbable suture.

2. The surgical kit of claim 1, further comprising at least one suture at least partially barbed.

3. The surgical kit according to any one of the preceding claims, wherein, The barbed portion of the suture should be at least 2 cm long.

4. The surgical kit according to claim 3, wherein, The at least one partially barbed suture includes a loop for securing the at least one partially barbed suture.

5. The surgical kit according to any one of the claims set forth herein, wherein, The antibacterial substance includes at least one of chlorhexidine and lidocaine.

6. The surgical kit according to any one of the preceding claims, wherein, The at least one barbed suture comprises at least one of the following materials: a.PTFE b. c. Polybutylene d. Polypropylene, and e. Polyester fiber.

7. The surgical kit according to any one of the preceding claims, wherein, The at least one absorbable suture comprises at least one of the following materials: a. Polylactic acid b. Glycolide-p-dioxanone c. Trimethylene carbonate d. gut e. Collagen f. Polylactic acid g. copolymer h. Poly(4-hydroxybutyrate) i.PHA j.Tephaflex k. Polycaprolactone l. Polyhydroxy fatty acid esters m.Maxon n.PDS o. Polyglycolic acid (PEG).

8. The surgical kit according to any one of the preceding claims, wherein, At least one of the at least partially barbed suture and the at least one absorbable suture is a monofilament suture.

9. The surgical kit according to any one of the preceding claims, wherein, At least one of the at least partially barbed suture and the at least one absorbable suture is a braided suture.

10. The surgical kit according to any one of claims 8 or 9, wherein, The suture includes a coating.

11. The surgical kit according to any one of the preceding claims, wherein, The motion restriction device includes at least two components, wherein the components are configured to be connected to each other to form at least a portion of a functional motion restriction device, and the at least two components are capable of being disconnected from each other, such that the at least two components can pass through the gastrointestinal tract independently.

12. The surgical kit of claim 11, further comprising a central component, wherein, The at least two components are configured to be connected to the central component to form at least a portion of the functional motion restriction device, and the central component and the at least two components are disconnectable from each other, such that the central component and the at least two components can pass through the gastrointestinal tract individually.

13. The surgical kit according to any one of the preceding claims, wherein, This functional motion restriction device is slender.

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