Treatment of gastroesophageal reflux disease

Abstract

The present disclosure relates to the treatment of reflux disease in a human patient. More particularly, a device configured to be implanted within a human patient to restrict the cardia of the patient's stomach from moving toward the diaphragm opening into the patient's rib cage and prevent stomach contents from passing from the stomach to the esophagus is disclosed.

Description

[Technical Field]

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

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

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

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

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

[0006] According to one aspect, an apparatus for treating reflux disease in a human patient is provided, the apparatus comprising an implantable movement restriction device and an electrode array. The implantable movement restriction device has a shape and size that enables it to be positioned to rest against a fundus wall portion of the patient's stomach and be positioned to be at least partially penetrated by the fundus wall portion, the movement restriction device being implanted at a position between the patient's diaphragm and a lower portion of the fundus wall so as to restrict movement of the patient's stomach cardia toward the diaphragm and prevent the cardia from sliding through an opening in the diaphragm and into the patient's rib cage. The electrode array is positioned between the movement restriction device and the fundus wall portion and is configured to engage and electrically stimulate muscle tissue in the fundus wall portion to cause muscle tissue movement and improve long-term implantation conditions of the movement restriction device.

[0007] According to one aspect, an apparatus for treating reflux disease in a human patient is provided, the apparatus comprising: an implantable movement restriction device having at least a portion thereof formed as a ring; and an electrode array. The implantable movement restriction device is configured to be at least partially penetrated by a first wall portion of the patient's stomach, the first portion being positioned such that at least a portion of the first portion is positioned above the cardiac notch of the patient's stomach, the first portion being configured to restrict movement of the cardia toward the diaphragm to prevent the cardia from sliding through the diaphragmatic opening into the patient's thorax. The electrode array is positioned between the movement restriction device and the first wall portion and configured to electrically stimulate muscle tissue in the first wall portion to cause muscle tissue movement and improve long-term implant conditions of the movement restriction device.

[0008] According to one aspect, a device for treating reflux disease in a human patient is provided, the device comprising an elongate core and a tubular covering. The elongate core has a length that enables the core to at least partially surround the patient's esophagus, the length being variable to enable the core to be positioned in a contracted state for preventing the passage of fluid from the stomach to the esophagus and an expanded state for allowing the passage of food to the stomach in response to the patient's swallowing. The tubular covering is configured to surround at least a portion of the core and is comprised of multiple sections adapted to flex relative to each other when the covering is at least partially covered by fibrous tissue to enable the core to change between the contracted state and the expanded state without being substantially hindered or inhibited by the presence of the fibrous tissue.

[0009] According to one aspect, a device for treating reflux disease in a human patient is provided, the device comprising an elongated core having a length that enables the core to at least partially surround the patient's esophagus, the length being variable to enable the core to be positioned in a contracted state for preventing the passage of fluid from the stomach to the esophagus and an expanded state for allowing the passage of food to the stomach in response to the patient's swallowing. The device further comprises an electrode array supported by the core and positioned between the device and the esophagus, the electrode array including electrode elements configured to electrically stimulate esophageal musculature.

[0010] According to one aspect, there is provided a device for treating reflux disease in a human patient, the device comprising a tubular device having a length that allows the device to at least partially surround the patient's esophagus, the tubular covering having a length that is variable to allow the device to be positioned in a contracted state to prevent fluid from passing from the stomach to the esophagus and an expanded state to allow food to pass to the stomach in response to the patient swallowing. An outer surface of the tubular device may include a plurality of portions adapted to flex relative to one another when the outer surface is at least partially covered with fibrous tissue to allow the tubular device to change between the contracted state and the expanded state without being substantially impeded or obstructed by the presence of said fibrous tissue.

[0011] According to one aspect, a device for treating reflux disease in a human patient is provided, the device comprising an elongated core having a length that allows the core to at least partially encircle the patient's esophagus. The length may be variable so that the core can be positioned in a contracted state to prevent the passage of fluid from the stomach to the esophagus and an expanded state to allow the passage of food to the stomach in response to the patient's swallowing. Furthermore, the elongated core has a size that allows at least a portion of the elongated core to protrude above the patient's sphincter when implanted, thereby restricting movement of the cardia toward the diaphragm and preventing the cardia from sliding through the diaphragmatic opening into the patient's rib cage.

[0012] According to one aspect, a device for treating reflux disease in a human patient is provided, the device adapted to at least partially surround the patient's esophagus (20). The device includes a first implantable portion and a second implantable portion, the first implantable portion having a shape and size that allows it to be positioned to rest against and be at least partially penetrated by a fundus wall portion of the patient's stomach. The first implantable portion is implanted at a position between the patient's diaphragm and a lower portion of the fundus wall of the stomach and restricts movement of the patient's gastric cardia toward the diaphragm to prevent the gastric cardia from sliding through an opening in the diaphragm and into the patient's thorax. The second implantable portion is elongated to at least partially surround the esophagus and has a variable length that allows the device to be positioned in a contracted state to prevent the passage of fluid from the stomach to the esophagus and an expanded state to allow the passage of food into the stomach in response to the patient's swallowing.

[0013] According to one aspect, a device for treating reflux disease in a human patient is provided, the device adapted to at least partially surround the patient's esophagus. The device includes a movement restriction device, an elongated support device, and an electrode array. The movement restriction device has a shape and size that allows it to be positioned to rest against and be at least partially penetrated by a fundus wall portion of the patient's stomach, and a first implantable portion is implanted at a position between the patient's diaphragm and a lower portion of the fundus wall, restricting movement of the patient's stomach cardia toward the diaphragm and preventing the cardia from sliding through an opening in the diaphragm and into the patient's thorax. The elongated support device is connected to the movement restriction device and configured to at least partially surround the esophagus. The electrode array includes electrode elements supported by the support device and configured to electrically stimulate esophageal musculature. Furthermore, the support device has a rigidity such that the position of the electrode elements relative to the esophagus is primarily determined by the position and orientation of the movement restriction device.

[0014] According to one embodiment, a method of treating reflux disease in a human patient is provided. The method includes implanting a movement restriction device positioned to restrict movement of the cardia of the patient's stomach toward the diaphragm and prevent the cardia from sliding through an opening in the diaphragm and into the patient's rib cage. The method includes positioning the movement restriction device so that a lower portion of the movement restriction device abuts the serosa at the His angle, and an upper portion of the movement restriction device abuts the His angle to define a gap between the movement restriction device and the patient's esophagus. The method further includes positioning a portion of a gastric fundus in the gap and attaching the gastric fundus to the patient's esophagus so that the movement restriction device is at least partially enclosed by the portion of the gastric fundus.

[0015] According to one aspect, an apparatus for treating reflux disease in a human patient is provided, the apparatus comprising: an implantable movement restriction device; and an elongated attachment attached to the movement restriction device and configured to be at least partially penetrated by a wall of the patient's stomach. The attachment is shaped and sized to be able to penetrate the wall to prevent rotation of the movement restriction device. The attachment is further configured to be positioned between the patient's diaphragm and the wall, such that the movement restriction device is positioned away from the patient's esophagus, and to be penetrated by the wall to restrict movement of the cardia of the patient's stomach toward the diaphragm and prevent the cardia from sliding through the diaphragmatic opening into the patient's thorax.

[0016] According to one aspect, a device for treating reflux disease in a human patient includes an implantable at least partially ring-shaped movement restriction device configured to have a first lower portion of the movement restriction device positioned at the cardia of the patient's stomach and a second upper portion of the movement restriction device positioned against the patient's diaphragm, restricting movement of the cardia toward the diaphragm to prevent the cardia from sliding through an opening in the diaphragm and into the patient's thorax. The device is further configured to be positioned to define a gap or spacing between the second upper portion of the movement restriction device and the exterior of the esophagus when the device is implanted. The device may be formed of, or at least consist of, a movement restriction device as disclosed herein.

[0017] According to one aspect, a method of treating reflux disease in a human patient is provided, comprising implanting a device including a movement restriction device and an elongated support device, wherein the support device at least partially surrounds the patient's esophagus, and the movement restriction device is positioned on the fundus side of the esophagus to restrict movement of the cardia relative to the diaphragm and prevent the cardia from sliding through the diaphragmatic opening and into the patient's thorax. The method includes the steps of introducing the device into the abdominal cavity, positioning the device so that the movement restriction device abuts the outside of the fundus, wrapping a portion of the fundus around at least a portion of the movement restriction device, and securing the fundus to the diaphragm, affixing the fundus to the esophagus and positioning the support device to at least partially surround the esophagus so that the movement restriction device is positioned between the diaphragm and the sphincter and a portion of the fundus is positioned between the movement restriction device and the esophagus, and the movement restriction device and the second portion form a ring-shaped body extending through the pouch to at least partially surround the esophagus.

[0018] According to one aspect, a method of affixing a fundus portion of a human patient's stomach to the patient's esophagus is provided, wherein the fundus portion extends away from the angle of His. The method includes folding the fundus upward along the esophagus from the angle of His so that the fundus rests relative to the esophagus, and affixing the fundus to the esophagus with fasteners disposed along first and second lines. The first and second lines extend along the esophagus and are positioned such that the distance between the first and second lines increases with increasing distance from the angle of His.

[0019] According to one aspect, there is provided a device for treating reflux disease in a human patient according to any of the above aspects, the device comprising an electrode array for electrically stimulating muscle tissue in the patient to exercise the muscle tissue and improve the long-term implant condition of the device, as generally described above, the device further comprising an implantable energy source configured to provide power to the electrode array, and a controller operably connected to the electrode array for controlling the electrical stimulation of the muscle tissue.

[0020] According to an aspect, there is provided a device for treating reflux disease in a human patient according to any one of the aspects above, comprising: an electrode array; an implantable energy source configured to power the device; an external energy source positioned outside the patient's body and configured to supply energy to the implantable energy source; and an implantable charger electrically connected to the implantable energy source and configured to allow charging of the implantable energy source by the external energy source.

[0021] According to one embodiment, there is provided an apparatus for treating reflux disease in a human patient according to any one of the above aspects, the apparatus comprising: an electrode array; and a controller configured to operatively connect to the electrode array to control electrical stimulation of muscle tissue, the controller comprising an implantable communicator for transmitting and / or receiving signals to and from outside the patient's body.

[0022] According to one embodiment of the above aspect, the electrode array may be disposed on an outer surface of the movement restriction device.

[0023] According to some embodiments of the above aspects, the electrode array may be comprised of a plurality of electrode elements, each configured to engage and electrically stimulate muscle tissue, and may further include a coiled wire to increase the contact area between the electrode array and the muscle tissue and enable the electrode array to follow the contraction and relaxation of the muscle tissue.

[0024] According to some embodiments of the above aspects, the electrode array may include bare electrode portions configured to form a metal-tissue interface with muscle tissue to allow faradaic charge transfer to be the predominant charge transfer mechanism at the interface. Alternatively, or additionally, the electrode array may be comprised of electrode portions at least partially covered by a dielectric material configured to form a dielectric-tissue interface with muscle tissue to reduce the faradaic portion of the charge transfer mechanism at the interface.

[0025] According to some embodiments, the electrode array may be configured to be positioned to electrically stimulate the sphincter muscle to cause it to contract. The electrode array may include at least two electrode elements configured to be positioned on opposite sides of the sphincter muscle. Further, the device may include a holder configured to support the at least two electrode elements on opposite sides of the sphincter muscle.

[0026] Exemplary embodiments of movement restriction devices according to at least some of the above aspects will now be described.

[0027] According to one embodiment, the volume of the movement restriction device may not be adjustable after implantation. According to another embodiment, the volume of the movement restriction device may be adjustable after implantation. The volume may be adjustable invasively or non-invasively. In one example, the movement restriction device includes an injection port to allow fluid to be injected or extracted from within the movement restriction device to change the volume of the movement restriction device after implantation.

[0028] According to one embodiment, the movement restriction device may comprise a biocompatible outer surface configured to rest against the fundus wall portion.

[0029] According to one embodiment, the movement restriction device may be substantially spherical or ovoid. In one example, the movement restriction device may have a portion configured to be positioned away from the esophagus when implanted. In a further example, a lower portion of the movement restriction device may be wider than an upper portion.

[0030] According to one embodiment, the movement restriction device may be configured to invert when placed on the outside of the fundus wall, hi another embodiment, the movement restriction device may be configured to invert when placed on the inside of the fundus wall.

[0031] According to one embodiment, the movement restriction device can be configured to be introduced into a patient's body by a gastroscope or an intraluminal device. The movement restriction device can be configured to change shape during insertion into a patient's body, for example, to allow it to pass through a trocar.

[0032] According to one embodiment, the movement restriction device may be formed from at least two separate separable parts that are configured to be assembled into a movement restriction device after insertion into a patient's body.

[0033] According to an embodiment the minimum width of the movement restriction device may be, measured from side to side, 20mm or more, such as 30mm or more, such as 40mm or more, such as 50mm or more.

[0034] According to some embodiments, the movement restriction device may include a first portion and a second portion, the first portion and the second portion configured to be positioned on opposite sides of the cardia. In one example, the movement restriction device may be configured to be positioned such that a gap is formed between the second portion of the movement restriction device and the esophagus. In one example, the second portion of the movement restriction device may be configured to be at least partially penetrated by a second wall of the stomach.

[0035] According to embodiments, the movement restriction device may be configured to be positioned such that a portion of the first wall is positioned between the first portion of the movement restriction device and the esophagus.

[0036] According to one embodiment, the movement limiting device may be configured to be at least partially eroded by the first wall along at least half of the toroidal length of the movement limiting device.

[0037] According to one embodiment, the movement restriction device can be configured to be invasive when placed outside the stomach wall.

[0038] According to one embodiment, the movement restriction device may comprise two ends configured to be joined together to form a closed ring. The ends may be configured to be releasably attached to one another.

[0039] According to an embodiment, the poloidal circumference of the movement restriction device may be greater in the first portion than in the second portion. In one example, the first portion of the movement restriction device has a minimum width, measured from side to side, of 20 mm or more, such as 30 mm or more, such as 40 mm or more, for example 50 mm or more. Alternatively, the width may be defined as the height measured along a normal to the plane in which the circumference extends.

[0040] According to one embodiment, the movement limiter may have a shape that fits into a torus.

[0041] According to one embodiment, the movement restriction device may have a C-shaped cross section.

[0042] According to one embodiment, the top of the movement restrictor may comprise a recess defined in the outer surface of the movement restrictor.

[0043] According to one embodiment, the lower portion of the movement restriction device may comprise a curved outer surface positioned to face the esophagus, and the curved outer surface may include a radius of curvature that corresponds to or exceeds the radius of curvature of the esophagus.

[0044] According to one embodiment, an elongate support protruding from the movement restriction device may be adapted to at least partially penetrate the fundus before the fundus is attached to the esophagus, and may be oriented along the esophagus.

[0045] Exemplary embodiments of a core and cover according to at least some of the above aspects will now be described.

[0046] According to some embodiments, the core may be configured to allow a transition from a contracted state to an expanded state caused by food passing through the esophagus, and the core may be configured to exert an enveloping pressure on the esophagus in the contracted state.

[0047] According to one embodiment, the device may further include an attractor for resiliently attracting adjacent portions of the core toward one another to generate the enveloping pressure. The attractor may be comprised of a resilient element and / or at least two mutually attracting magnets. The device may further include a link connecting a first magnet and a second magnet of the at least two magnets to one another. The link may be configured to extend into at least one of the magnets in response to the magnets moving toward one another.

[0048] According to some embodiments, the core may include two end portions configured to be joined together to form a closed ring around the esophagus. The end portions may be configured to be releasably attached to each other and may include respective interlocking attachments.

[0049] According to one embodiment, the core may be comprised of a plurality of core elements configured to be arranged annularly around the esophagus. The core may further include a plurality of links, each link extending between a respective pair of adjacently positioned core elements. The links may be configured to allow the respective core elements to move toward and away from each other, and may be configured to extend into at least one of the core elements of each pair of core elements as the core elements move toward each other.

[0050] According to one embodiment, the cover may be comprised of an array of tubular segments.

[0051] According to some embodiments, the cover may include a biocompatible outer surface for long-term implantation. The cover may be configured to rest against the outer surface of the esophagus, for example, and may further include a surface for promoting tissue growth. The cover may be formed of a polymeric material, such as silicone. In a further example, the cover may be formed of or comprised of a carbon-based material, such as a carbon fiber material.

[0052] According to some embodiments, the cover may be formed of a material having a thickness of 0.1 to 10 mm, e.g., 1 to 5 mm. The cover may include at least one predefined fold that allows the cover to fold in response to the core changing its length. In some examples, the cover may be composed of lowered and raised portions that allow the cover to change its length while maintaining its surface area. Thus, the cover may be configured to be compressible and expandable along its length, with the length changing primarily due to the folding of the cover rather than the elastic properties of the material. Thus, the cover may be considered to be formed of a non-elastic material. In some examples, the length of the cover surrounding at least a portion of the core may exceed the length of at least a portion of the core when at least a portion of the core is disposed in a contracted state.

[0053] Next, as discussed above in connection with some aspects, exemplary embodiments of an attacher that is shaped and sized to allow it to be eroded by a wall to prevent rotation of the movement restriction device will be described below.

[0054] According to some embodiments, the first end of the attacher may be configured to be engulfed by a wall portion, and the second end may be configured to be attached to the movement limiting device. The first and second portions may extend in different directions relative to each other, and the first portion may be configured to be engulfed by the wall portion to prevent rotation of the movement limiting device about a first axis, and the second portion may be configured to be engulfed by the wall portion to prevent rotation of the movement limiting device about a second axis different from the first axis. The first and second portions of the attacher may be curved to follow the curvature of the wall portion. The first and second portions may be disposed at an angle to each other, the angle being between 60 and 120 degrees, for example, 90 degrees.

[0055] According to some embodiments, the attacher may be configured to be releasably attached to the movement limiting device. The attacher may be configured to allow the position of the movement limiting device to be adjusted after extension of the attachment means. In some examples, the device may be configured to allow the distance between the movement limiting device and the attacher to be changed so that the position of the movement limiting device relative to the diaphragm can be adjusted. Furthermore, the device may be configured to allow the orientation of the movement limiting device relative to the attachment means to be changed so that the position of the movement limiting device relative to the diaphragm can be adjusted.

[0056] In one embodiment, the attacher may include a third portion configured to protrude from the wall when implanted and to define a distance between the wall and the movement restriction device. The third portion may include a curvature that enables the third portion to be positioned away from the esophagus when implanted.

[0057] According to one embodiment, the movement limiting device and the attacher may be integrally formed.

[0058] According to one embodiment, the movement restriction device and attachment means may each be comprised of a biocompatible outer surface. The attacher may include an outer surface configured to promote tissue growth. In some examples, the attacher may be formed of a metal. In a further example, the movement restriction device may be formed of a polymer.

[0059] According to one embodiment, the outer surface of the movement restriction device can be made of a material to prevent the growth of fibrous tissue.

[0060] Next, an exemplary embodiment of a method for treating reflux disease in a human patient by implanting a device including a movement restriction device and an elongate support device, as described in some aspects above, will be described.

[0061] According to one embodiment, the device can be positioned so that the movement restriction device rests against the outside of the fundus, at a location between the sphincter and the portion that is anchored to the esophagus.

[0062] According to one embodiment, the device can be positioned such that the portion of the fundus anchored to the esophagus is positioned between the sphincter and the migration restriction device.

[0063] According to one embodiment, the pouch can be configured to open in at least two positions to form a tunnel through which the device extends.

[0064] According to one embodiment, a portion of the fundus may be affixed to the patient's diaphragm.

[0065] According to one embodiment, securing a portion of the fundus to the esophagus may include suturing or stapling.

[0066] According to one embodiment, the support device can comprise a first end and a second end that are introducible into the esophagus, and the first and second ends can be coupled together to annularly secure the support device in the esophagus.

[0067] According to one embodiment, the method further includes inserting a needle or tubular device into the patient's abdomen, filling the abdomen with gas using the needle or tubular device, positioning at least two laparoscopic trocars in the abdomen, inserting a camera into the abdomen through one of the laparoscopic trocars, inserting at least one dissection device through one of the laparoscopic trocars, dissecting a portion of the stomach, and at least partially closing the pouch with sutures, such as bar sutures, or staples.

[0068] In the following, an exemplary embodiment of a method for affixing a gastric fundus of a human patient to the patient's esophagus according to the above aspects is described.

[0069] According to one embodiment, the abdominal esophagus and the fundus of the stomach can be divided into a ventral and a dorsal plane. The method comprises creating a first line on the dorsal side of the plane and a second line on the ventral side. The first line begins 1 cm above the angle of His, and the second line begins 3 cm above the angle of His. In some instances, the second line begins less than 2 cm from the first line.

[0070] According to one embodiment, the separation angle between the first line and the second line may be in the range of 90 to 150 degrees.

[0071] According to some embodiments, the method may include providing an additional fastener between the first line and the second line at the top of the fundus.

[0072] In some instances, the fasteners may include staples. In some instances, the fasteners may be comprised of sutures, such as barbed sutures. For example, the first line of fasteners may comprise a first continuous suture, and the second line of fasteners may comprise a second continuous suture.

[0073] According to some embodiments, the method may further include placing a movement restriction device in the fundus of the stomach, forming a pouch in the fundus, at least partially placing the movement restriction device in the pouch, and inserting the movement restriction device into the fundus by at least partially zipping the pouch. The movement restriction device may be positioned between the diaphragm and the sphincter and prevent the heart from sliding through the diaphragmatic opening into the patient's thorax. The movement restriction device may also be inserted after the fundus of the stomach is secured to the esophagus. The pouch may also be formed with at least two openings to form a tunnel through which the movement restriction device extends. As an example, the fundus of the stomach may be secured to the diaphragm.

[0074] According to some embodiments, an energy source may be provided. The energy source may be configured to be implanted within the patient's body. The energy source may be configured to power energy-consuming components of the implant. Examples of energy-consuming components include controllers, sensors, electrodes, etc., as outlined above in connection with the previous embodiments and examples. Thus, in some embodiments, the energy source may be configured to power an electrode array, i.e., electrodes, as outlined above.

[0075] The implantable energy source may be configured to be disposed within or integrated with an implantable device, such as a movement restriction device, support device, attachment means, core, or cover, according to any of the embodiments and examples described above. In some examples, the energy source, or a portion of the energy source, may be configured to be implanted externally to the device or implantable device, for example, subcutaneously.

[0076] The energy source may comprise a primary battery (galvanic battery) that is designed to be discarded after use and not recharged like a secondary battery. Alternatively, or additionally, the energy source may comprise a secondary battery (rechargeable battery) that is designed to be repeatedly charged.

[0077] According to some embodiments, the implantable energy source can be configured to be charged by an external energy source, i.e., an energy source located outside the patient's body. This can be accomplished, for example, by an implantable charger that is electrically connected to the implantable energy source and configured to allow charging of the implantable energy source by the external energy source. Thus, the charger can be configured to transfer power from outside the patient's body to the implantable energy source. Power transmission can be performed wirelessly, for example, from the external energy source, and in some examples, the charger can comprise an electromagnetic coil to facilitate power transmission.

[0078] According to some embodiments, the charger may be configured to control charging of the implantable energy source by controlling the reception of power from the external energy source at the implantable charger and / or by controlling the transmission of power from the external energy source to the implantable charger.

[0079] According to some embodiments, charging of the implantable energy source can be controlled based on the functional state of the implantable energy source. This can be achieved, for example, by controlling the power supplied or emitted by the external energy source, or by controlling the power received by the charger as outlined above. Additionally, in some instances, charging is controlled by controlling the power supplied from the charger to the implantable energy source, by controlling the power output from the charger, or by controlling the power received or absorbed by the implantable energy source. It will thus be appreciated that charging of the implantable energy source can be controlled by varying or controlling the power supplied by the external energy source at any point along the way to the implantable energy source. As exemplified above, the power supplied to the implantable energy source can thus be controlled by the external energy source, the charger, or the implantable energy source itself.

[0080] The functional status of the implanted energy source includes, for example, charge level and temperature. Temperature may be associated with the energy source, muscle tissue, or parts of the implant, such as the electrode array. Thus, charging may be reduced or even stopped if the charge level (or stored energy) reaches an upper limit or if the temperature exceeds a predetermined interval.

[0081] According to some embodiments, a controller (or processor or control circuit) may be provided for controlling various parts or functions of an implanted apparatus or device according to any of the above-described embodiments. The controller may be configured, for example, to include the functional status of the implanted energy source in a signal transmitted outside the body.

[0082] The controller may be operably connected to the electrode array to control electrical stimulation of the muscle tissue. The stimulation may be controlled, for example, so that the muscle tissue is stimulated with a series of electrical pulses. The electrical pulses may be characterized by their voltage and / or current. In some examples, a pulse of a first polarity may be followed by a pulse of a second, opposite polarity. The first polarity may be, for example, a positive current relative to the direction of current flow, and the second polarity may be a negative current. Alternatively, or additionally, the first polarity may be characterized by a positive voltage relative to a reference, such as ground, and the second polarity may be characterized by a negative voltage.

[0083] The controller may be configured to generate a pulsed electrical stimulation signal having a pulse frequency of 0.01-150 Hz, a pulse duration of 0.01-100 ms, and a pulse amplitude of 1-15 mA. A specific example of the electrical stimulation signal may be characterized by a pulse frequency of 0.15-0.25 Hz, a pulse duration of 20-30 ms, and a pulse amplitude of 3-10 mA.

[0084] The controller may be further configured to generate a pulsed electrical stimulation signal having varying configurations, including different durations, such as a build-up period of gradually increasing amplitude, a stimulation period during which stimulation continues, and a pause period during which stimulation is paused. Thus, by way of example, the electrical stimulation signal may include a build-up period of 0.01-2 seconds, a stimulation period of 1-60 seconds, and a rest period of 0.01-60 seconds. During the build-up and stimulation periods, the signal may include a pulse frequency of 1-50 Hz and a pulse duration of 0.1-10 ms. These durations may be varied and combined depending on the desired stimulation of muscle tissue and may further be varied based on responses monitored, for example, by a sensor connected to the controller. The sensor may be configured to measure, for example, the motor response of the muscle tissue, measured as mechanical movement or electrical response.

[0085] According to some embodiments, an implantable sensor for sensing action potentials generated by pacemaker cells in muscle tissue may be provided. The sensor is communicatively coupled to a controller, and the controller is configured to control electrical stimulation based at least in part on the sensed action potentials. This is particularly advantageous when stimulating smooth muscle tissue that may exhibit periodic contractions paced by pacemaker cells. Thus, this embodiment provides a remote control that allows for adjusting the electrical stimulation signal to amplify the sensed action potentials.

[0086] According to some embodiments, the controller may comprise an external controller configured to be placed outside the patient's body and an internal controller configured to be placed inside the patient's body, or an implantable controller. The wireless remote control may comprise an external signal transmitter configured to communicate with the internal controller. The internal controller may thus be configured to receive a signal transmitted by the external signal transmitter and control operation of the device or medical implant based on the signal. The signal, in some examples, is selected from the group consisting of an acoustic signal, an ultrasonic signal, an electromagnetic signal, an infrared signal, a visible light signal, an ultraviolet signal, a laser signal, a microwave signal, a radio wave signal, an X-ray signal, and a gamma ray signal.

[0087] The various apparatus and methods according to the above aspects may be combined with any of the features, examples, and advantages described herein. [Brief explanation of the drawings]

[0088] The above, as well as additional objects, features and advantages of the inventive concept will be better understood through the following illustrative and non-limiting detailed description taken in conjunction with the accompanying drawings. [Figure 1] 1A-1C are schematic diagrams of various examples of devices for treating reflux disease, the devices being implanted within a patient's body. [Figure 2] 1A-1C are schematic diagrams of various examples of devices for treating reflux disease, the devices being implanted within a patient's body. [Figure 3] 1A-1C are schematic diagrams of various examples of devices for treating reflux disease, the devices being implanted within a patient's body. [Figure 4] 1A-1C are schematic diagrams of various examples of devices for treating reflux disease, the devices being implanted within a patient's body. [Figure 5] 1A-1C are schematic diagrams of various examples of devices for treating reflux disease, the devices being implanted within a patient's body. [Figure 6A]1A-1C are schematic diagrams of various examples of devices for treating reflux disease, the devices being implanted within a patient's body. [Figure 6B] 1A-1C are schematic diagrams of various examples of devices for treating reflux disease, the devices being implanted within a patient's body. [Figure 7] 1A-1C are schematic diagrams of various examples of devices for treating reflux disease, the devices being implanted within a patient's body. [Figure 8] 1A-1C are schematic diagrams of various examples of devices for treating reflux disease, the devices being implanted within a patient's body. [Figure 9] 1A-1C are schematic diagrams of various examples of devices for treating reflux disease, the devices being implanted within a patient's body. [Figure 10] 1A-1C are schematic diagrams of various examples of devices for treating reflux disease, the devices being implanted within a patient's body. [Figure 11] 1A-1C are schematic diagrams of various examples of devices for treating reflux disease, the devices being implanted within a patient's body. [Figure 12] 1 is a schematic diagram illustrating a further example of a device for treating reflux disease. [Figure 13] 1 is a schematic diagram illustrating a further example of a device for treating reflux disease. [Figure 14] 1 is a schematic diagram illustrating a further example of a device for treating reflux disease. [Figure 15] 1 is a schematic diagram illustrating a further example of a device for treating reflux disease. [Figure 16] 1 is a schematic diagram illustrating a further example of a device for treating reflux disease. [Figure 17] 1 is a schematic diagram illustrating a further example of a device for treating reflux disease. [Figure 18A] 1 is a schematic diagram illustrating a further example of a device for treating reflux disease. [Figure 18B] 1 is a schematic diagram illustrating a further example of a device for treating reflux disease. [Figure 18C] 1 is a schematic diagram illustrating a further example of a device for treating reflux disease. [Figure 18D]1 is a schematic diagram illustrating a further example of a device for treating reflux disease. [Figure 18E] 1 is a schematic diagram illustrating a further example of a device for treating reflux disease. [Figure 18F] 1 is a schematic diagram illustrating a further example of a device for treating reflux disease. [Figure 18G] 1 is a schematic diagram illustrating a further example of a device for treating reflux disease. [Figure 18H] 1 is a schematic diagram illustrating a further example of a device for treating reflux disease. [Figure 18I] 1 is a schematic diagram illustrating a further example of a device for treating reflux disease. [Figure 18J] 1 is a schematic diagram illustrating a further example of a device for treating reflux disease. [Figure 19A] 1 is a schematic diagram of an example of a device for treating reflux disease, the device being implanted within a patient, and showing the device in an expanded state. [Figure 19B] 1 is a schematic diagram of an example of a device for treating reflux disease, the device being implanted within a patient, and showing the device in a deflated state. [Figure 20A] 1A-1C are schematic diagrams illustrating various examples of devices for treating reflux disease. [Figure 20B] 1A-1C are schematic diagrams illustrating various examples of devices for treating reflux disease. [Figure 21] 1A-1C are schematic diagrams illustrating various examples of devices for treating reflux disease. [Figure 22] 1A-1C are schematic diagrams illustrating various examples of methods for treating reflux disease and / or implanting devices for treating reflux disease. [Figure 23A] 1A-1C are schematic diagrams illustrating various examples of methods for treating reflux disease and / or implanting devices for treating reflux disease. [Figure 23B] 1A-1C are schematic diagrams illustrating various examples of methods for treating reflux disease and / or implanting devices for treating reflux disease. [Figure 23C]1A-1C are schematic diagrams illustrating various examples of methods for treating reflux disease and / or implanting devices for treating reflux disease. [Figure 24] 1A-1D are schematic diagrams of various examples of devices for at least partially encircling the esophagus to treat reflux disease. [Figure 25] 1A-1D are schematic diagrams of various examples of devices for at least partially encircling the esophagus to treat reflux disease. [Figure 26] 1A-1D are schematic diagrams of various examples of devices for at least partially encircling the esophagus to treat reflux disease. [Figure 27] 1A-1D are schematic diagrams of various examples of devices for at least partially encircling the esophagus to treat reflux disease. [Figure 28] 1A-1C are schematic diagrams illustrating a method of implanting a device in a patient to treat reflux disease. [Figure 29] 1A-1C are schematic diagrams illustrating various examples of devices for treating reflux disease. [Figure 30] 1A-1C are schematic diagrams illustrating various examples of devices for treating reflux disease. [Figure 31A] 1A-1C are schematic diagrams illustrating various examples of devices for treating reflux disease. [Figure 31B] 1A-1C are schematic diagrams illustrating various examples of devices for treating reflux disease. [Figure 31C] 1A-1C are schematic diagrams illustrating various examples of devices for treating reflux disease. [Figure 31D] 1A-1C are schematic diagrams illustrating various examples of devices for treating reflux disease. [Figure 31E] 1A-1C are schematic diagrams illustrating various examples of devices for treating reflux disease. [Figure 31F] 1A-1C are schematic diagrams illustrating various examples of devices for treating reflux disease. [Figure 32] 1A-1C are schematic diagrams illustrating various examples of devices for treating reflux disease. [Figure 33] 1A-1C are schematic diagrams illustrating various examples of devices for treating reflux disease. [Figure 34]1A-1C are schematic diagrams illustrating various examples of devices for treating reflux disease. [Figure 35] 1A-1C are schematic diagrams illustrating various examples of devices for treating reflux disease. [Figure 36] 1A-1C are schematic diagrams illustrating various examples of devices for treating reflux disease. [Figure 37A] 1A-1C are schematic diagrams illustrating various examples of devices for treating reflux disease. [Figure 37B] 1A-1C are schematic diagrams illustrating various examples of devices for treating reflux disease. [Figure 37C] 1A-1C are schematic diagrams illustrating various examples of devices for treating reflux disease. [Figure 38A] 1A-1C are schematic diagrams illustrating various examples of devices for treating reflux disease. [Figure 38B] 1A-1C are schematic diagrams illustrating various examples of devices for treating reflux disease. [Figure 39] 1 is a schematic cross-sectional view showing the stomach anatomy of a human patient. [Figure 40A] 1 shows various examples of electrode arrangements for electrically stimulating muscle tissue of a patient. [Figure 40B] 1 shows various examples of electrode arrangements for electrically stimulating muscle tissue of a patient. [Figure 40C] 1 shows various examples of electrode arrangements for electrically stimulating muscle tissue of a patient. [Figure 40D] 1 shows various examples of electrode arrangements for electrically stimulating muscle tissue of a patient. [Figure 41] 1 shows a pulse signal for electrically stimulating muscle tissue. [Figure 42] 1 shows a pulse signal for electrically stimulating muscle tissue. [Figure 43] 1 is a schematic diagram of a system for treating reflux disease. [Figure 44] 1 is a schematic diagram of a system for treating reflux disease. [Figure 45] 1 is a schematic diagram of a system for treating reflux disease. [Figure 46]1 is a cross-sectional view of a human patient with a reflux treatment system implanted therein. [Figure 47A] 1 is a cross-sectional view of an implantable remote unit for powering an implantable medical device. FIG. [Figure 47B] 1 is a cross-sectional view of an implantable remote unit for powering an implantable medical device. FIG. [Figure 48] 1 is an exploded cross-sectional view of an implantable remote unit for powering an implantable medical device. FIG. [Figure 49A] FIG. 2 is a detailed cross-sectional view of a first unit of an implantable remote unit for powering an implantable medical device. [Figure 49B] FIG. 2 is a detailed cross-sectional view of a first unit of an implantable remote unit for powering an implantable medical device. [Figure 49C] FIG. 2 is a detailed cross-sectional view of a first unit of an implantable remote unit for powering an implantable medical device. [Figure 50A] 10 illustrates an alternative embodiment of a connection portion of an implantable remote unit. [Figure 50B] 10 illustrates an alternative embodiment of a connection portion of an implantable remote unit. [Figure 51A] 1 shows a schematic diagram of a kit of components forming an implantable remote unit. [Figure 51B] 1 shows a schematic diagram of a kit of components forming an implantable remote unit. [Figure 52A] FIG. 1 is a detailed cross-sectional view of one embodiment of an implantable remote unit for powering an implantable medical device. [Figure 52B] FIG. 1 is a detailed cross-sectional view of one embodiment of an implantable remote unit for powering an implantable medical device. [Figure 53] FIG. 1 is a right perspective elevation view of one embodiment of an implantable remote unit for powering an implantable medical device. [Figure 54] FIG. 1 is a right perspective elevation view of a portion of an embodiment of an implantable remote unit for powering an implantable medical device. [Figure 55] FIG. 1 is a right perspective elevation view of a portion of an embodiment of an implantable remote unit for powering an implantable medical device. [Figure 56] FIG. 1 is a cross-sectional plan view of an implantable remote unit for powering an implantable medical device. [Figure 57] FIG. 1 is a cross-sectional plan view of an implantable remote unit for powering an implantable medical device. [Figure 58A] FIG. 1 is a cross-sectional plan side view of an embodiment of an implantable remote unit for powering an implantable medical device. [Figure 58B] FIG. 1 is a cross-sectional plan side view of an embodiment of an implantable remote unit for powering an implantable medical device. [Figure 58C] FIG. 1 is a cross-sectional plan side view of an embodiment of an implantable remote unit for powering an implantable medical device. [Figure 58D] FIG. 1 is a cross-sectional plan side view of an embodiment of an implantable remote unit for powering an implantable medical device. [Figure 59A] 1 illustrates an embodiment of an implantable remote unit for powering an implantable medical device. [Figure 59B] 1 illustrates an embodiment of an implantable remote unit for powering an implantable medical device. [Figure 59C] 1 illustrates an embodiment of an implantable remote unit for powering an implantable medical device. [Figure 59D] 1 illustrates an embodiment of an implantable remote unit for powering an implantable medical device. [Figure 60] FIG. 1 is a right perspective elevation view of one embodiment of an implantable remote unit for powering an implantable medical device. [Figure 61] FIG. 1 is a plan top view of one embodiment of an implantable remote unit for powering an implantable medical device. [Figure 62A] 1A-1C are plan views schematically illustrating two embodiments of an implantable remote unit for powering an implantable medical device. [Figure 62B]1A-1C are plan views schematically illustrating two embodiments of an implantable remote unit for powering an implantable medical device. [Figure 63A] 1A-1C illustrate three stages of insertion and fixation of an embodiment of an implantable remote unit for powering an implantable medical device. [Figure 63B] 1A-1C illustrate three stages of insertion and fixation of an embodiment of an implantable remote unit for powering an implantable medical device. [Figure 63C] 1A-1C illustrate three stages of insertion and fixation of an embodiment of an implantable remote unit for powering an implantable medical device. [Figure 64] FIG. 1 is a detailed cross-sectional view of one embodiment of an implantable remote unit for powering an implantable medical device. [Figure 65A] 1 illustrates a communication system according to some embodiments. [Figure 65B] 1 illustrates a communication system according to some embodiments. [Figure 65C] 1 illustrates a communication system according to some embodiments. [Figure 65D] 1 illustrates a communication system according to some embodiments. [Figure 65E] 1 illustrates a communication system according to some embodiments. [Figure 66A] 1 illustrates a communication system according to some embodiments. [Figure 66B] 1 illustrates a communication system according to some embodiments. [Figure 66C] 1 illustrates a communication system according to some embodiments. [Figure 66D] 1 illustrates a communication system according to some embodiments. [Figure 66E] 1 illustrates a communication system according to some embodiments. [Figure 66F] 1 illustrates a communication system according to some embodiments. [Figure 66G] 1 illustrates a communication system according to some embodiments. [Figure 66H] 1 illustrates a communication system according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0089] Detailed explanation Hereinafter, a detailed description of embodiments of the present invention will be provided with reference to the accompanying drawings. It will be understood that the drawings are for illustrative purposes only and do not limit the scope of the present invention in any way. Accordingly, references to directions such as "up" and "down" merely refer to the directions shown in the drawings. It should be noted that features having the same reference numerals have the same functions, and therefore, a feature of one embodiment may be interchanged with a feature of another embodiment having the same reference numeral, unless there is a clear contradiction. Therefore, descriptions of features having the same reference numerals should be considered to complement each other in explaining the basic idea of ​​the feature, thereby demonstrating the versatility of the feature.

[0090] 1 is a schematic diagram of a device 100 according to some embodiments of the present disclosure. The device 100 can be used to treat human patients suffering from gastroesophageal reflux disease (GERD), also known as reflux disease. As shown in this figure, the device 100 can include a migration restriction device 110 configured to be implanted in the stomach 10 to prevent the cardia 22 from sliding through the diaphragmatic opening 32, and an electrode array 150 for stimulating and exercising musculature of the stomach 10 to improve long-term implant conditions.

[0091] The movement restriction device 110 may be positioned to rest against the fundus wall portion 14 of the stomach 10. In this example, the movement restriction device 110 is positioned to rest against the outside of the stomach wall. However, in alternative examples and embodiments, the movement restriction device 110 may be positioned to rest against the inside of the stomach wall.

[0092] The movement restriction device 110 can have a shape and size that allows it to be fully or at least partially penetrated by the fundus wall 14. This can be achieved by forming a pouch or recess in the fundus wall 14 and at least partially closing the opening of the pouch or recess to prevent the movement restriction device 110 from being removed from the fundus wall 14. Penetration by the fundus wall 14 can place the movement restriction device 110 in a position between the patient's diaphragm 30 and the lower part of the fundus wall 12, restricting movement of the cardia 22 toward the diaphragm 30. Restricting this movement can prevent the cardia 22 from sliding up toward, and possibly through, the diaphragmatic opening 32 and into the patient's rib cage, thereby maintaining supportive pressure on the sphincter 26 exerted by the abdomen.

[0093] 1 , the movement restriction device 110 can be coupled, or affixed, to the esophagus 20 at a location above the sphincter 26. The fixation of the movement restriction device 110 is preferably indirect, achieved by anchoring a portion of the gastric fundus 14 to the esophagus 20 to act as a mechanical stop for the diaphragm 30 as the esophagus moves upward through the diaphragmatic opening 32. Furthermore, to protect the tissue of the esophagus 20 from damage by the movement restriction device 110, the movement restriction device 110 can also be implanted such that a portion of the gastric fundus is positioned between the movement restriction device 110 and the outside of the esophagus 20.

[0094] The shape and size of the movement restriction device 110 are important factors in enabling the invasive portion to act as a mechanical stop against the diaphragm 30. Preferably, the movement restriction device 110 can be sized and shaped to have an erosion large enough to prevent the fundus wall 14 from sliding through the diaphragmatic opening 32 along with the cardia. Furthermore, the movement restriction device 100 can be sized and shaped to penetrate the fundus 12 without unduly reducing the total volume of the gastric cavity. In addition, the movement restriction device 100 can be small enough to simultaneously create a mechanical stop against the diaphragm muscle while leaving the food passage substantially intact and unaffected. Thus, the movement restriction device 100 disclosed herein advantageously enables addressing the symptoms of reflux disease while reducing the risk of compressing the food passage.

[0095] To facilitate entry and reduce the risk of damaging tissue in the fundus wall portion 14, the movement restriction device 110 can have a substantially smooth outer surface. Any corners, edges, joints, or seams can be rounded so as not to damage or irritate the tissue against which the movement restriction device 110 rests when implanted. In some examples, the movement restriction device 110 can have a rounded shape that conforms to, for example, a sphere, a spheroid, or an egg.

[0096] The minimum width of the movement restriction device 110, as measured from side to side, can, in some examples, be 30 mm or greater, e.g., 40 mm or greater. Additionally or alternatively, the minimum circumference of the movement restriction device 110 can be 150 mm or less, e.g., 130 mm or less, e.g., 110 mm or less. In further examples, the minimum circumference can be 90 mm or less, e.g., 70 mm or less, e.g., 50 mm or less, e.g., 30 mm or less. However, it will be appreciated that the dimensions of the movement restriction device can vary depending on the anatomy of the actual individual into whom the movement restriction device 110 is implanted. The size and shape of the movement restriction device 110 can be tailored to the individual patient so that the intervention can act as a mechanical stop as outlined above, thereby affecting reflux disease.

[0097] The movement restriction device 110 can be formed of a biocompatible material suitable for long-term implantation in the human body. Alternatively, or additionally, the outer surface of the movement restriction device 110 may comprise a layer or coating of such a material. Examples of biocompatible materials include medical-grade metal alloys such as titanium or medical-grade stainless steel. Alternatively, the movement restriction device 110 may be constructed from a ceramic material such as zirconium carbide, or a rigid medical-grade polymer material such as ultra-high molecular weight polyethylene (UHMWPE) or polytetrafluoroethylene (PTFE), or a thermoplastic polyester such as polylactic acid (PLA). The movement restriction device 110 may also be constructed from at least one composite material, such as any combination of metal / ceramic and polymer materials, or a polymer material reinforced with organic or inorganic fibers, such as carbon or mineral fibers. Additionally, the movement restriction device may be constructed from a housing made from one or a combination of carbon-based materials (such as graphite, silicon carbide, carbon fiber materials), boron materials, polymeric materials (such as silicon, Peek, polyurethane, UHWPE, PTFE), metallic materials (such as titanium, stainless steel, tantalum, platinum, niobium, aluminum), ceramic materials (such as zirconium dioxide, aluminum oxide, tungsten carbide), or glass.

[0098] Furthermore, movement restriction device 110, according to some embodiments, is configured to be introduced into a patient's body by a gastroscope or endoluminal device, thereby allowing device 100 to be implanted by natural orifice transluminal endoscopic surgery (NOTES). Accordingly, movement restriction device 110 can have a shape and size that allows a tubular device to be introduced and passed therethrough. In some embodiments, movement restriction device 110 may be configured, preferably elastically, to change its shape to temporarily assume a minimum width that allows movement restriction device 110 to pass through such a device.

[0099] The device 100 may further include an electrode array 150 configured to be positioned between the movement restriction device 110 and the stomach wall portion 14 when the device 100 is implanted. The electrode array portion 150 may be configured to electrically stimulate muscle tissue in the stomach wall portion 14 to cause muscle tissue motility, thereby improving the long-term implant condition of the movement restriction device 110. The electrode array portion 150 may include at least one electrode element 152 configured to contact tissue against which the movement restriction device 110 will rest when implanted and to deliver electrical impulses to the muscle tissue. It will be understood that the electrode element 152 may be positioned in direct contact with the muscle tissue or indirect contact via intermediate tissue, such as connective tissue or fibrous tissue. Thus, the electrode array 150 may be configured to rest against, contact, or engage tissue at least partially surrounding the implanted movement restriction device 100. The interaction of the electrode array 150 with muscle tissue is described in more detail in connection with Figures 38-41.

[0100] The electrode elements 152 may be attached directly to the exterior surface of the movement restriction device 110, as shown in Figure 1. However, in some embodiments, the electrode elements 152 may be disposed on a support, such as a flexible patch configured to be attached to a medical implant. In further embodiments, the electrode array 150 may be provided as a separate, physically distinct item from the movement restriction device 110.

[0101] The device 100 may further include an implantable energy source 160, which may be configured to provide power to the electrode array 150 for electrically stimulating muscle tissue. The energy source 160 may be incorporated within the movement restriction device 110, as shown here, such that the energy source 160 is disposed within the movement restriction device 110 and electrically connected to an electrode element 152 disposed between the outer surface of the movement restriction device 110 and the fundus wall 12. The energy source 160 may, in some embodiments, be disposed external to the movement restriction device 110 as well, or may be formed as a separate structure that is implantable elsewhere, such as in the abdomen or subcutaneously.

[0102] According to some embodiments, energy source 160 may comprise a primary battery, i.e., a battery designed not to be recharged. In further embodiments, energy source 160 may include a secondary battery designed to be recharged by an external energy source, preferably located outside the patient's body. Various examples of charging energy source 160 and powering electrode array 150, along with examples of methods for controlling and operating electrode array 150, are described in connection with Figures 42-44.

[0103] Figure 2 is a schematic diagram of a device 100 according to some embodiments, which may be configured similarly to the embodiment described with reference to Figure 1. Thus, the device 100 is shown implanted in a patient to treat reflux disease and may include a movement restriction device 110 and an electrode array 150 for generating electrical signals that cause muscle cells in the fundus wall 14 to repeatedly contract and relax. This effect, i.e., cell movement, caused by an electrode array such as that shown in Figures 1 and 2, has been found to have a positive effect in that it helps prevent tissue degradation and damage and increase tissue resistance to pressure and mechanical forces generated by medical implants.

[0104] This embodiment differs from that of FIG. 1 in that the movement restriction device is coupled to a user interface that allows a person, such as a patient or medical staff, to interact with the device 100. More specifically, the user interface can allow communication with and / or control of the implant's operation. It can also provide a means for powering the implant. The user interface may comprise a peripheral device 174, such as a regulator or push button, connected to the movement restriction device 110 via a communication path 172, such as a wire or electrical lead. The peripheral device 174 can be implanted subcutaneously, for example, to facilitate access from outside the body. A user, such as the patient or medical staff, can interact with the peripheral device 174 to adjust or control the electrical stimulation of muscle tissue. The peripheral device 174 can be used, for example, to start or stop stimulation or to adjust the electrical signal used for stimulation, as described in connection with FIGS. 38-41 . The electrical stimulation can be regulated and controlled by a control device (not shown), which can be located within the movement restriction device 110, integrated into the peripheral device 174, implanted elsewhere in the body, or located externally. If the control device is located externally, control signals can be sent to the implanted device via the peripheral device 174. Such a control device can consist, for example, of an energy source, an electrical switch, or an injection port for varying the volume of the movement restriction device, depending on the actual situation and implantation application.

[0105] The electrode array 150 may comprise a plurality of electrode elements 152 distributed over the exterior surface of the movement restriction device 110 so that tissue in contact with the movement restriction device can be electrically stimulated to cause movement. Each of the electrode elements 152 may comprise a contact pad or surface configured to form an interface with the surrounding tissue and electrically connect to circuitry within the movement restriction device 110. The circuitry is configured to generate an electrical signal, e.g., a pattern of electrical pulses, that is transmitted to the muscle tissue via the electrode elements 152.

[0106] FIG. 3 illustrates a device 100 for treating reflux disease in a human patient when implanted in the patient. The device 100 may be configured similarly to the devices disclosed in connection with FIGS. 1-3 , except for an elongated support device 120 that may be configured to at least partially surround the esophagus 20. Thus, the device 100 of FIG. 3 may comprise a movement restriction device 110 configured to be implanted to prevent the cardia from sliding through the diaphragmatic opening, as described above, and an elongated support device 120 that may be connected to the movement restriction device 110 in a manner such that the elongated support device 120 is held in place around the esophagus 20 by the movement restriction device 110. The elongated support device 120 may include mechanical stability, or rigidity, such that its position relative to the esophagus 20 is primarily determined by the position and orientation of the movement restriction device 110. Thus, the elongated support device 120 may be implanted and maintain its position without being anchored to the tissue of the esophagus 20.

[0107] The elongated support device 120 may be formed as a bracket or brace shaped to conform to at least a portion of the exterior of the esophagus 20. In some examples, the elongated support device 120 may have a shape that conforms to the letter "C." The elongated support device 120 may be formed from the same material as the movement restriction device 110, or from a different material. Examples of materials include metals and polymers. Additionally, the elongated support device 120 may include a surface layer or coating configured to prevent or reduce the growth of fibrous tissue.

[0108] The elongated support device 120 may be integrally formed with the movement restriction device 110 such that the movement restriction device 110 and the elongated support device 120 form a single unit. The elongated support device 120 may therefore be referred to as a protrusion of the movement restriction device 110, and has a length and orientation relative to the body of the movement restriction device 110 that allows the protrusion to be at least partially positioned around the esophagus 20. In the alternative, the elongated support device 120 and the movement restriction device 110 may be formed as separate parts that can be joined or attached to each other during implantation.

[0109] Similar to the movement restriction device 110, the elongated support device 120 can be formed of a biocompatible material suitable for long-term implantation in the human body. Alternatively, or additionally, the exterior surface of the elongated support device 120 can be provided with a layer or coating of such material. Examples of biocompatible materials include medical-grade metal alloys, such as titanium or medical-grade stainless steel. Alternatively, the support device 120 can be constructed from a ceramic material, such as zirconium carbide, or a rigid medical-grade polymer material, such as ultra-high molecular weight polyethylene (UHMWPE) or polytetrafluoroethylene (PTFE), or a thermoplastic polyester, such as polylactic acid (PLA). The support device 120 can also be constructed from any combination of metal / ceramic and polymer materials, or at least one composite material, such as a polymer material reinforced with organic or inorganic fibers, such as carbon or mineral fibers. Additionally, the support device 120 may be comprised of a housing made from one or a combination of carbon-based materials (such as graphite, silicon carbide, carbon fiber materials), boron materials, polymeric materials (such as silicon, Peek, polyurethane, UHWPE, PTFE), metallic materials (such as titanium, stainless steel, tantalum, platinum, niobium, aluminum), ceramic materials (such as zirconium dioxide, aluminum oxide, tungsten carbide), or glass.

[0110] The device 100 may further include an electrode array 150 supported by the elongated support device or holder 120 and comprising electrode elements 154 configured to electrically stimulate muscle tissue of the esophagus 20. Thus, the electrode elements 154 may be positioned between the holder 120 and the exterior of the esophagus 20 and configured to deliver electrical stimulation signals to the tissue of the esophagus 20.

[0111] The electrical stimulation of the tissue may be similar to that described above for the movement restriction device 110, i.e., to exercise muscle tissue to improve conditions for long-term implantation. However, in additional or alternative embodiments, the electrical stimulation may be configured to contract the sphincter 26. In the present embodiment of FIG. 3, the device 100 may include an electrode array 150 for electrically stimulating muscle tissue adjacent to the implanted movement restriction device 110 and for electrically stimulating the sphincter 26. However, it will be understood that the electrode array 150 may be comprised of electrode elements 154 for stimulating only the sphincter 26. In other words, the electrode array 150 in the movement restriction device 110 may be optional.

[0112] The electrode array 150 may be comprised of at least two electrode elements 154 supported by the elongated support device 120 at two different locations, preferably on opposite sides, of the cardia 22 to allow the sphincter 26 to be electrically stimulated. The electrode array 150 may be controlled to alternate between at least two modes: an operating mode in which the sphincter 26 is stimulated with electrical energy, and a resting mode in which the sphincter 26 is not stimulated to allow muscle tissue to recover.

[0113] Device 100 may further include a user interface consisting of peripherals 174 and communication channel 172, which may be configured similarly to the embodiment described above in connection with FIG. 2. The user interface may allow the patient or medical staff to select when electrode array 150 is in active mode and when it is in rest mode. For example, some patients may only need stimulation "on" temporarily while the patient is experiencing reflux symptoms, such as at night while the patient is lying down, while other patients may require continuous stimulation of sphincter 26 except when eating.

[0114] The user interface may also allow the power of the electrical signal to be adjusted over time, for example, the power used for stimulation may be increased to compensate for an increase in resistance at the junction between the electrode elements 154 and the tissue caused by the formation of fibrous tissue.

[0115] As shown in this figure, the device 100 may include an energy source 160 for providing power to the electrode array 150. The energy source 160 may be implantable at a location external to the movement restriction device 110, such as, for example, subcutaneously as shown in FIG. 3. Accordingly, the communication channel 172 may be configured to transmit power, i.e., electrical signals, from the energy source 160 to the electrode array 150. The communication channel 172 may be comprised, for example, of electrical conductors for electrically connecting the electrode array 150 of the elongate support device 120 (and optionally the movement restriction device 110) with the energy source 160.

[0116] It will be understood that there are various ways to implant the movement restriction device 110 in the fundus wall portion 14, and that Figures 1-3 are merely illustrative. In Figures 1-3, the movement restriction device 110 is entered into the fundus wall portion 14 from outside the stomach. Multiple stomach-to-stomach sutures or staples can be applied to hold the entry intact and maintain the movement restriction device 110 in a desired position relative to the cardia 22 and diaphragm 30 in an upright patient. This allows for fibrous tissue growth over time to keep the entry intact.

[0117] Additionally or alternatively, anchorages may be provided between the fundus wall 14 and the diaphragm 30 and / or between the fundus wall 14 and the esophagus 20, as shown in Figure 4. The movement restriction device 110 depicted in Figure 4 may be configured similarly to the embodiments described in connection with Figures 1-3, and thus Figure 4 discloses a movement restriction device 110 implanted in the fundus 12 and positioned above the cardia 22 to provide a mechanical stop that relieves symptoms of reflux disease. The movement restriction device 110 may also include an electrode array 150 for electrically stimulating and exercising muscle tissue affected by the implanted device 110, as described above.

[0118] 4, however, the movement restriction device 110 is entered from the inside of the stomach 10, rather than from the outside. Therefore, the movement restriction device 110 is adapted to rest against a portion of the inner wall of the fundus wall portion 14, at a location between the diaphragm 30 and at least a portion of the lower portion of the invaded fundus wall 12. After the invasion, multiple intergastric sutures or staples may be applied from the inside of the stomach 10 to keep the invasion intact and allow for tissue growth to maintain the invasion over time. Additional fasteners may be provided between the outside of the fundus wall portion 14 and the esophagus 20 and / or diaphragm muscle 30 to hold the movement restriction device 110 in the desired position.

[0119] The movement restriction device 110 disclosed in FIGS. 1-4 can have several different configurations and is not necessarily limited to the schematic version diagrammatically depicted therein. Other configurations and designs are contemplated within the concept of the present invention, as defined by the appended claims. One example of such a variation is shown in FIG. 5, which shows a movement restriction device 110 similar to that of FIGS. 1-4, but formed of multiple segments 111 configured to be attached for assembly into the complete movement restriction device 110. The segments 111 can be secured together by interlocking structures 114, such as protruding slits, receiving grooves, snap-fit ​​connectors, or the like. In this embodiment, the movement restriction device 110 can be formed of five segments 111: four outer portions 112 and an inner core portion 113 around which the outer portions 112 can be positioned to form a rounded, substantially smooth body suitable for penetration. The segments 111 can be configured to be securely attached to each other, or loosely attached and held in place by the surrounding fundus wall 12 when penetrated. In some embodiments, the segments 111 can be secured together by wires. The wires may be biodegradable and eventually dissolve. The segments 111 may be configured to be introduced into a patient's body separately, one at a time, and assembled into the movement restriction device 110 in connection with implantation.

[0120] As shown in this figure, multiple electrode elements 152 may be disposed on the outer surface of the segments 111, i.e., on the surface of the outer piece 112 that is to be positioned to rest against the fundus wall 14 when the assembled movement restriction device 110 is implanted. The segments 111 may be electrically connected to each other so that an electrical stimulation signal can be transmitted to the electrode elements 152 on the outer surface of the movement restriction device 110.

[0121] The movement restriction device 110 according to any of the above-described embodiments can have an adjustable or non-adjustable volume after implantation. In the case of a non-adjustable volume, the movement restriction device 110 may be formed of a body (or several segments) that is solid, i.e., not hollow, and / or made of substantially the same material throughout. This may allow the shape to change while the volume remains substantially the same during insertion into the body, for example, via a tubular device. In the case of a movement restriction device 110 that is adjustable in volume, the device may be formed of a body (or several segments) that includes one or several cavities or voids that can store and release fluid to cause corresponding expansion and contraction of the movement restriction device 110. The fluid may be, for example, a gas or a liquid such as a gel, and can be introduced and extracted from the movement restriction device 110 before, during, or after implantation.

[0122] 6A and 6B illustrate an example of a movement restriction device 110 similar to that described with reference to FIGS. 1-5, including a fluid communication port 115, or injection port, that can be used to add or remove fluid from the movement restriction device 110 to change its volume. It may be desirable to adjust the volume of the movement restriction device 110 post-operatively to fine-tune or adjust the ability of the movement restriction device 110 to act as a mechanical stop against the diaphragm. For example, after implantation, subsequent evaluation of the surgical results may determine that a different size implant would have been more optimal for a particular patient. This can be resolved by post-operatively adjusting the implant volume.

[0123] As shown in this figure, the port 115 can be positioned to be accessible from outside the invasion site, i.e., to allow access to the port 115 by a device or connection without penetrating the fundus wall 14. In Figure 6A, the port protrudes outside the invasion site, passing between the sutures or staples used to at least partially close the pouch in which the movement restriction device 110 is placed. Thus, the port 115 can be connected to a tube or syringe from the patient's abdominal region. In Figure 6B, the port 115 is positioned inside the entry site and accessed by a tube 116 connected to the port 115 and extending to the patient's abdominal region.

[0124] The volume of the movement restriction device 110, according to some embodiments, can be non-invasively adjusted after implantation. Non-invasive adjustment may be permitted by tubing 116 connected to port 115 and leading outside the patient's body or leading to an implanted volume adjuster, such as a pump or reservoir, to non-invasively adjust the volume of the movement restriction device 110. According to other embodiments, the volume of the movement restriction device 110 can be adjusted invasively, for example, by a device inserted inside the patient's body and connected directly to port 115 or tubing 116 to add or remove fluid from the movement restriction device 110. Alternatively, or additionally, a device such as a syringe may be inserted directly into the movement restriction device 110 and passed through the surrounding fundus wall portion 14 on its way to the movement restriction device 110.

[0125] It will be understood that the adjustable and non-adjustable characteristics of the volume of the movement restriction device 110 generally refer to the permanent state of the movement restriction device 110. In other words, volume adjustment, in the above context, may result in a new volume that is substantially constant over time until the amount of fluid within the movement restriction device 110 is changed again. This may be contrasted with a temporary change in volume that may be caused, for example, by temporary or elastic compression of the material forming the movement restriction device 110. Such a temporary change in volume may occur, for example, during introduction of the movement restriction device 110 into the body, such as via a tubular device. In other words, the movement restriction device 110 according to the embodiments outlined above with reference to FIGS. 1-6 may be flexible or elastic, allowing the device 110 to assume, at least temporarily, different shapes, and in some embodiments, volumes, in response to exposure to an external mechanical force.

[0126] A device for treating reflux disease as described above will now be described with reference to Figures 7-13. The figures schematically show device 100, which comprises an at least partially ring-shaped implantable movement restriction device configured to be at least partially penetrated by a first wall of a patient's stomach 10, with at least a portion of the first portion of device 100 positioned above cardia 22 of the patient's stomach 10 and including a first portion 110 positioned to restrict movement of the cardia toward the diaphragm so as to prevent cardia 22 from sliding through diaphragmatic opening 32 into the patient's thorax. Accordingly, the configuration and function of first portion 110 of device 100 may be similar to movement restriction device 110 described above with reference to Figures 1-6. Additionally, device 100 may include an electrode array 150, which may be similar to the electrode array 150 described in connection with the embodiment of FIGS. 1-6, and thus may be configured to be positioned between first portion 110 and first wall portion 14 of device 100 to electrically stimulate muscle tissue in first wall portion 14 to cause muscle tissue exercise, thereby improving the conditions for long-term implantation of device 100.

[0127] The device 100 may further include a second portion 120, which may be configured to be positioned on the opposite side of the cardia 22 from the first portion 110. The first portion 110 and the second portion 120 may together form at least partially ring-shaped movement restriction devices 110, 120, which may be configured to be positioned to at least partially surround the patient's esophagus 20, as shown in this figure. The first portion 110 may be configured, for example, to be positioned on the fundus side of the esophagus 20, while the second portion 120 may be configured to be positioned on the side of the esophagus 20, i.e., opposite the fundus 12. In some cases, the movement restriction device 110 is formed of a substantially smooth, ring-shaped body configured to surround the esophagus 20. The movement restriction device 110 may have a shape that conforms to a torus, for example, with a first portion 110 forming a portion that is positioned on the fundus side of the esophagus, and a second portion 120 forming a portion that is positioned on the opposite side of the esophagus 20.

[0128] The ring-shaped body of the movement restriction device 110 may include or be openable to allow the body to be positioned around the esophagus. After the movement restriction device 110 is positioned around the esophagus 20, the movement restriction device 110 can be secured in a desired position, preferably at least partially above the cardia 22, by, for example, encroaching at least one of the first and second portions 110 and 120 through the outer wall of the stomach 10 or by wrapping a portion of the stomach wall around at least a portion of the ring-shaped body. Preferably, the movement restriction device 110 is implanted such that a portion of the stomach wall is positioned between the movement restriction device 110 and the exterior of the esophagus 20 to protect the esophageal tissue from damage caused by contact between the movement restriction devices 110 and 120. As shown in the embodiment of FIGS. 7-9, a portion of the fundus 12 can be positioned between the first portion 110 and the esophagus 20 while simultaneously securing the device to the stomach 10. Additionally, the migration restriction device can have a shape and size that can define and maintain a gap between the second portion 120 and the side of the esophagus opposite the side of the stomach fundus. By securing the first portion 110 to the stomach fundus 12, a separating gap between the second portion 120 and the tissue of the esophagus 20 can be maintained after placement.

[0129] Figure 10 shows an alternative example in which the second portion 120 of the movement restriction device 110, 120 is positioned on the side of the esophagus 20 facing the fundus 12 so that a portion of the stomach wall is between the second portion 120 and the esophagus 20. However, on the fundus side, the first portion 110 may be positioned to define a distance or gap with the esophagus 20, similar to that described in Figures 7 to 9.

[0130] 11 shows a further example in which the first portion 110 is positioned at the angle of His and the second portion 120 may be penetrated by a pouch protruding into the stomach wall opposite the esophagus 20. The pouch may be positioned further downward compared to the example of FIG. 10. As a result, while in FIG. 10 the first portion 110 and the second portion 120 are positioned at substantially the same height relative to the cardia, in FIG. 11 only the first portion 110 is positioned at least partially above the cardia 22.

[0131] 12 and 13 show various examples of at least partially ring-shaped movement restriction devices 110, 120, where the first and second portions 110, 120 may be integrally formed as shown in FIG. 12 or may be formed of multiple core elements 213 disposed within a cover 220 as shown in FIG. 13. The movement restriction devices 110, 120 may conform to a torus, for example, and may be closed or at least partially closed when implanted. Similar to the devices shown in FIGS. 7-11, the device may be implanted in a position that at least partially surrounds the esophagus 20 and may function as a movement restriction device. The device may further include an electrode array 150.

[0132] The electrode array 150 of the embodiment shown in Figures 7-13 may comprise one or several electrode elements 152, 154 positioned between the first and / or second portions 110, 120 and the tissue against which the respective portions 110, 120 rest, and operating according to principles similar to those described with reference to Figures 1-6. Thus, the electrode array 150 may be configured to electrically stimulate and exercise muscle tissue in the fundus wall 12 or esophagus 20 to improve conditions for long-term placement, and in some instances, to electrically stimulate the sphincter 26 to contract it. In the latter case, the second portion 120 may be configured to function as an elongate support for the sphincter-stimulating electrode element 154, similar to the embodiment disclosed in connection with the previous figures.

[0133] Device 100 may be configured to be at least partially invaded or covered by the stomach wall along at least half of its toroidal length (i.e., the length in the circumferential direction surrounding the esophagus). An example is shown in Figure 8, where a toroidal shaped device is at least partially covered by the fundus 14 along at least half of its toroidal length. Similar arrangements are shown in Figures 7, 9, 10, and 11, where at least 25%, e.g., 50%, of the circumferential length of the device may be at least partially invaded or covered by stomach wall tissue.

[0134] As shown in perspective views in Figures 8, 12 and 13, device 100 may be substantially ring-shaped and may be comprised of two ends configured to be joined together to form a closed ring. The ends are configured to be releasably attached to one another, for example, by a locking mechanism 216 or fasteners 216.

[0135] If the device is at least partially ring-shaped or conforms to a torus, the size of the device can be characterized by its poloidal and toroidal circumferences. The poloidal direction is understood to be the direction along the small circular ring of the surface, while the toroidal direction is understood to be the direction along the large circular ring of the torus or ring surrounding the central cavity in which the esophagus is located. In some examples, the poloidal circumference of the device can be larger in the first portion 110 than in the second portion 120, as shown in Figures 12 and 13. Preferably, the first portion 110 forming the movement restriction device 110 can have a larger poloidal circumference to provide a mechanical stop that prevents movement of the cardia toward and / or through the diaphragm opening.

[0136] In some examples, the first portion 110 may have a smallest width or cross-section measured perpendicular to the toroidal direction of 30 mm or more, such as 40 mm or more.

[0137] In some examples, the minimum poloidal circumference of the first portion 110 of the movement restriction device may be 150 mm or less, such as 130 mm or less, for example 110 mm or less, for example 90 mm or less, for example 70 mm or less, for example 50 mm or less, for example 30 mm or less.

[0138] In some examples, the maximum width of a cross section across the length (i.e., across the toroidal direction) of the first portion 110, i.e., the movement restriction device 110, may be greater than the maximum width of a cross section across the length (i.e., across the toroidal direction) of the second portion 120, i.e., the support device 120.

[0139] Device 100 can be affixed to the stomach wall in several different ways, all of which can include at least partially wrapping the stomach wall 10 around at least a portion of device 100, affixing the stomach wall 10 to itself and / or the esophagus 20. Some non-limiting examples of positioning and securing device 100 to the stomach wall 10 will now be described with reference to ring-shaped movement restriction devices 110, 120 disclosed in Figures 7-13.

[0140] 7, the movement restriction device is positioned around the esophagus 20, with the first portion 110 positioned on the fundus side and the second portion 120 positioned on the opposite side of the esophagus. A portion of the fundus wall 12 is then wrapped around the first portion 110 of the movement restriction device from the outside of the movement restriction device into the central hole of the ring-shaped body, so as to be positioned between the inner circumferential surface of the ring-shaped body and the esophagus 20. The portion of the fundus wall 12 wrapped around the first portion 110 can be thought of as a formed "flap" of the fundus wall, which is formed on the outside of the ring-shaped body, pushed into the hole defined by the ring-shaped body, and attached to the esophagus 20.

[0141] 8 is a perspective view of a device 100, which may be similar to that of FIG. 7, illustrating the application of a first portion 110, 120 of a movement restriction device 110 to the gastric fundus 12. The portion of the gastric fundus wrapped around the first portion 110 and secured to the esophagus may form a tunnel with the ring-shaped body extending around the esophagus.

[0142] 9 shows another example in which the portion of the fundus closest to the angle of His is folded upward along the esophagus from the angle of His to rest against the esophagus and affixed to the esophagus with one or more rows of fasteners, such as staples or sutures, that extend along the esophagus. A first portion 110 of the movement restriction device can then be invaded by another portion of the fundus positioned further away from the angle of His, such that the movement restriction device is held in place by the fixation to the esophagus and a second portion 120 surrounds the esophagus such that it is positioned on the opposite side of the esophagus.

[0143] 7 and 8, the first part 110 is positioned between the esophagus 20 and the part of the fundus attached to the esophagus 20, while the method according to Figure 9 may result in the part of the fundus 12 attached to the esophagus 20 being positioned between the esophagus 20 and the first part 110 of the movement restriction device. In the former example, a part of the fundus may be pushed into the hole in the ring-shaped body from below, while in the latter example, a part of the fundus may be pushed into the hole from above.

[0144] 10 illustrates a method similar to that of FIG. 7, except that it is the side of the stomach wall opposite the fundus, i.e., the non-fundus side, that is wrapped around the second portion 120, introduced into the opening defined by the ring-shaped body, and affixed to the esophagus. The portion of the stomach wall 10 closest to the esophagus 20 may also be folded to rest against the esophagus 20 and affixed to the esophagus 20, similar to the example of FIG. 9, so that the second portion 120 of the migration restriction device can be positioned higher, preferably above the sphincter 26. The portion of the stomach wall closest to the esophagus 20 may be attached to the esophagus 20 before the stomach wall is wrapped around the second portion 120 and introduced into the opening defined by the ring-shaped body.

[0145] A device for treating reflux disease in a human patient, according to several embodiments, will now be described with reference to FIGS. 14-21. FIGS. 14-21 illustrate a device 100 comprising an elongated core 210 having a length that allows the core 210 to be positioned to at least partially surround the esophagus 20 of an adult human patient. The length is variable so that the core 210 can be positioned in a contracted state to prevent the passage of fluid from the stomach 10 into the esophagus 20 and an expanded state to allow the passage of food into the stomach 10 in response to the patient's swallowing. Thus, the device can be used to treat reflux disease by assisting in the contraction of the sphincter 26 and preventing stomach contents from ascending into the esophagus 20. The transition from the contracted state to the expanded state can be triggered by food passing through the esophagus 20, and the core 210 can be configured to exert a surrounding pressure on the esophagus 20 at least in the contracted state. The surrounding pressure can be generated, for example, by an attractor 212 configured to resiliently attract adjacent portions 213 of the core toward one another. Additionally, device 100, according to certain embodiments, may include an electrode array 150 including electrode elements 154 positioned between device 100 and esophagus 20 and configured to electrically stimulate musculature of esophagus 20. Electrical stimulation may be employed, for example, to stimulate musculature in the outer wall of esophagus 20 to cause musculature movement and improve conditions for long-term placement of device 100, and / or to stimulate the patient's sphincter muscles 26 to cause sphincter muscles 26 to contract.

[0146] FIG. 14 illustrates a core 210 comprised of an array of adjacent segments 213 interconnected by pullers 212. The segments 213 of the array may be, for example, ball-shaped and have a substantially smooth outer surface suitable for resting against the tissue of the outer wall of the esophagus 20. The segments 213 may be formed, for example, of a metal or polymer, and preferably comprise a biocompatible outer surface suitable for long-term implantation within the body. The pullers 212 connecting adjacent segments 213 to one another may comprise elastic elements such as elastic bands or strings that can resiliently move the segments 213 away from one another when they enter an expanded state (e.g., in response to a patient swallowing a bolus of food) and then pull the adjacent segments 213 toward one another again to a contracted state to prevent the passage of stomach contents into the esophagus 20. The core 210 may be comprised of a plurality of pullers 212, each of which may have a knuckle end connected to a first segment 213 and a second end connected to a second segment 213. Thus, each puller 212 may be positioned to extend from a first of a pair of adjacent portions 213 to the other of the pair of adjacent portions 213. Alternatively, a single puller 212 may be positioned to interconnect two or more portions 213 of core 210. As shown in FIG. 14 , pullers 212 may be formed of strings or bands that extend through each portion 213 of core 210.

[0147] The core 210 may further include an attacher 216, i.e., a locking means, disposed at an end portion of the array of adjacent portions 213. The attacher 216 may, for example, consist of a first part disposed at a first end portion that may be inserted into or attached to a second part disposed at the other end portion of the core 210. Examples of attachers 216 include interlocking parts, snap fasteners, and screw assemblies.

[0148] Alternatively, or additionally, the resilience of the core 210, allowing it to assume expanded and contracted states and exert a surrounding pressure on the esophagus 20, may be achieved at least in part by an attractive force between the permanent magnets. In this case, portions of the array may be comprised of permanent magnets 213, which may be arranged such that there is a mutual attractive force between adjacent magnets 213 of the array. The magnets 213 may be attached to one another by connectors or links, such as the bands or strings 212 described above, which may or may not be elastic, to further contribute to the resilience of the core and its ability to exert a surrounding pressure on the esophagus 20. The magnets 213 may also be referred to as attractors.

[0149] Figure 15 illustrates an example in which core 210 comprises a plurality of magnetic portions 213, i.e., permanent magnets 213, arranged in an array extending along the length of elongated core 210. Thus, the embodiment of Figure 15 may be configured similarly to device 100 shown in Figure 14, except that device 100 includes a tubular cover 220 that surrounds at least a portion of core 210. Cover 220 may include a plurality of portions 222 adapted to flex relative to one another when cover 220 is at least partially covered by fibrous tissue, allowing core 210 to change between a contracted state and an expanded state substantially unhindered or impeded by the presence of the fibrous tissue.

[0150] When a foreign body is implanted in the human body, an inflammatory response tends to occur. This response generally persists until the foreign body is enveloped in a relatively dense layer of fibrous connective tissue, protecting the body from the foreign body. This process may begin with the implant immediately and naturally acquiring a layer of host proteins. The surface modified with blood proteins allows cells to adhere to the surface and allows monocytes and macrophages to interact with the implant surface. Macrophages secrete proteins that regulate fibrosis, forming a fibrotic capsule around the foreign body, i.e., the implant. In practice, the fibrotic capsule can form a dense layer of excess fibrous connective tissue. The inelastic properties of the fibrotic capsule can cause hardening, tightening, deformation, and distortion of the implant, potentially requiring further surgery. For medical devices implanted in the abdominal and gastric regions, the fibrotic capsule has typically been observed to grow to a thickness of approximately 0.5–2 mm.

[0151] The presence of such a fibrous tissue capsule risks impeding the movement of the elongated core 210 of the device 100, as described in connection with the embodiment of FIGS. 14-21. In particular, the presence of a relatively thick, inelastic layer of fibrous tissue may hinder the ability of the core 210 to change between an expanded and a contracted state. To address this issue, the elongated core 210 may be disposed within or at least partially covered by a cover 220, allowing the core 210 to change its length without being substantially hindered by the fibrous tissue surrounding the cover 220. This is made possible by the cover 220's ability to change its length without stretching the material from which it is formed. Fibrous tissue is inelastic, allowing it to withstand stretching but easily bends and folds. Thus, the cover 220 can be thought of as taking advantage of the fact that fibrous tissue may inherently be more flexible than elastic, allowing the device to change its length (or circumference, when positioned around the esophagus 20) by bending and flexing portions of the core relative to one another. In other words, cover 220 may be configured to maintain a substantially constant surface as the core changes between the expanded and contracted states, thereby allowing the length of elongate core 210 to change without correspondingly stretching the surrounding fibrous tissue. Thus, cover 220 may have a length that exceeds the length of core 210 when core 210 is disposed in the contracted state.

[0152] FIG. 15 illustrates an example of a cylindrical cover 220 arranged to house an array of permanent magnets 213. The permanent magnets 213 may be attached to one another by attractors 212, such as those described above in connection with FIG. 14, or may be freely disposed within the cover 220 without interconnections. In some embodiments, the permanent magnets 213 may be affixed to the cover 220 such that each permanent magnet 213 is maintained in a predetermined position relative to the cover 220. When transitioning from the expanded state to the contracted state, adjacent magnets 213 may be attracted toward one another such that the distance between the magnets 213 in the array decreases. The cover 220 may follow this movement such that portions of the cover 220 disposed between the magnets 213 fold or bend relative to portions of the cover 220 disposed over the respective magnets 213, thereby configuring the cover 220 to be compressible and expandable along its length.

[0153] Cover 220 can be configured with a biocompatible outer surface suitable for long-term placement in the human body, preferably in contact with the outer surface of esophagus 20. In some examples, the cover comprises a surface that promotes tissue growth. Cover 220 can be formed of, or at least consist of, a polymeric material (e.g., silicone, Peek, polyurethane, UHWPE, PTFE, etc.). Additionally, the cover can have a wall thickness of 0.1 to 5 mm. In some examples, cover 220 can include a coating, such as parylene, polytetrafluoroethylene (PTFE), polyurethane, or a combination of such coatings, to improve wear resistance.

[0154] Additionally, the cover may include an electrode array 150 similar to that described above in connection with the embodiment of Figure 14. Accordingly, the electrode array 150 may include at least one electrode element 154 configured to be disposed between the cover 220 and the esophagus 20 to electrically stimulate the musculature of the esophagus 20. The electrode element 154 may be configured, for example, to stimulate the musculature on the outer surface of the esophagus and / or to contract the sphincter 26 to improve conditions for long-term placement.

[0155] FIG. 16 illustrates an example of a device 100 that may be configured similarly to the device described in connection with FIGS. 14 and 15 . However, as shown in this figure, the cover 220 may be configured with at least one predefined fold 224 that allows the cover to fold in response to the core 210 changing its length. In some embodiments, the cover 220 may be configured with a concertina-like structure of multiple lowered and raised portions 225 and 226, which allows the cover 220 to change its length while maintaining its surface area substantially constant. The distance between two raised portions 226 may be long enough to prevent fibrous tissue growth directly connecting adjacent raised portions 226. Thus, while fibrous tissue may grow on the surfaces of the lowered and raised portions 225 and 226, the distance between adjacent raised portions 226 may prevent fibrous tissue from growing directly from one raised portion 226 to another without first passing over the intermediate lowered portion 225. Thus, the covering 220 may be comprised of ridges and grooves, or ridges 226 and depressions 225, sized such that connective tissue runs along the surfaces of the ridges 226 and depressions 225, leaving separating gaps between adjacent ridges 226 or depressions. As an example, if the fibrous tissue has a thickness of about 0.5-1.5 mm, the distance between adjacent ridges 226 may be greater than twice the maximum thickness of the fibrous tissue, i.e., greater than about 3 mm.

[0156] FIG. 17 illustrates a device 100 that may be configured similarly to the embodiments of FIGS. 14-16. However, FIG. 17 further discloses an implantable energy source 160 for powering the electrode array 150 for electrical stimulation of muscle tissue. The energy source 160 may be integrated within the elongated core 210, such as within one or more of the sections 213, as shown in this figure. However, the energy source 160 may, in some embodiments, also be located external to the device 100, forming a separate structure implantable elsewhere, such as in the abdomen or subcutaneously. The energy source 160 may comprise a primary battery, i.e., a battery designed not to be recharged. In further embodiments, the energy source 160 may include a secondary battery designed to be recharged by an external energy source, preferably located outside the patient's body. Various examples of charging the energy source 160 and powering the electrode array 150, along with examples of methods for controlling and operating the electrode array 150, are described in connection with FIGS. 42-44.

[0157] 18A and 18B illustrate a device 100 that may be configured similarly to the embodiment shown in FIGS. 14-17. The device 100 may include an elongated core 210 having a variable length that allows the device to be positioned to at least partially surround the esophagus 20 in a contracted state to prevent stomach contents from passing into the esophagus 20 and an expanded state to allow a food bolus to pass into the stomach 10 in response to the patient swallowing. The surrounding pressure acting on the esophagus 20 may be generated by a plurality of aspirators 212, which in this embodiment may comprise permanent magnets arranged in pairs that attract each other. In FIGS. 18A and 18B, the elongated core 210 is formed from an array of links 214, such as rods or levers, that extend along the length of the elongated core 210 and have permanent magnets 213 attached to each end portion. By positioning the magnets 213 at the distal ends of the links 214 so that the magnets 213 of adjacent links attract each other, the attractive force between the magnets 213 can be used to transition the elongated core from the expanded state shown in FIG. 18A to the contracted state shown in FIG. 18B. In the contracted state shown in FIG. 18B, adjacent magnets 213 are positioned closer together than in the expanded state of FIG. 18A. If allowed to move freely, adjacent magnets 213 may butt up against each other. When a patient swallows food or liquid, the passing material may cause the esophagus 20 to expand radially. This expansion creates an expansion force acting on the device 100, which may eventually overcome the attractive force between the magnets 213, causing the core 210 to expand around itself and assume the expanded state. As the food or liquid passes through the device 100, the attractive (or contractile) force within the device 100 again overcomes the expansion force of the esophagus 20, causing the core 210 to contract its circumference and return to the contracted state.

[0158] The device 100 may further include a cover 220 surrounding at least a portion of the elongated core 210. The cover 220 may be similar to the cover 220 described in connection with FIGS. 15-17 and may be configured to prevent fibrous tissue from growing directly on the elongated core 210. Additionally, the cover 220 may be configured to provide mechanical support to elements of the elongated core 210, such as the link 214 carrying the magnet 213. The cover 220 may be tubular, consisting of a wall that at least partially surrounds or encloses the elongated core 210, and having an at least partially hollow interior that can accommodate elements of the core 210. According to the illustrated embodiment, the cover 220 may be comprised of an array of tubular segments 222 arranged along the length of the elongated core 210. In this embodiment, segment 222 may be configured to house at least two mutually attractive magnets 213, a first of which may be attached to an end of a first link 214 and a second of which may be attached to an end of a second adjacent link 214 of elongated core 213. Variation in the length of core 210 as device 100 transitions between the expanded and contracted states may thus be achieved by the magnets moving toward or away from each other along the length of core 210 within segment 222 in which they are housed.

[0159] Cover 220 may be configured to accommodate / accommodate changes in length of core 210 by allowing first and second portions of cover 220 to flex relative to one another to compensate for the changing length without stretching the material of cover 220. The first and second portions may be separated by fold line 224, as shown, and may further be considered as lowered portions 225 and raised portions 226, respectively. Stated differently, segments 222 of cover 220 may be configured to act as bellows, compressing and expanding in response to contraction and expansion of elongated core 210. Cover 220 may include one or more additional segments 223 disposed between adjacent segments 222 that comprise magnets 213, as described above, to house portions of links 214 interconnecting magnets 213.

[0160] The dimensions and configuration of the cover 220 can be adapted to allow the fibrous tissue to at least partially wrap around the outside of the cover 220, preferably in a layer that follows the contours of the outer segments, allowing different portions of the cover 220 to bend or fold relative to each other as they flex rather than stretch the fibrous tissue.

[0161] The cover 220 may further include an electrode array 150, similar to the cover 220 disclosed in Figures 15 and 16, for electrically stimulating the muscle tissue of the esophagus 20. Preferably, the electrical stimulation may be adjusted to compensate for the presence of fibrous tissue that prevents the electrode elements from directly contacting or engaging the muscle tissue. Thus, as described in more detail in connection with Figures 38-41, the presence of fibrous tissue at the interface or junction between the electrical elements and the muscle tissue may be compensated for by adjusting the electrical stimulation signal accordingly.

[0162] 18C-J show an example of a device 100 that may be configured similarly to the embodiments described in connection with FIGS. 7-17 and 18A-18B. However, as shown in FIGS. 18C-E, the device 100 may be configured, when implanted, to have limited or no contact with tissue outside the esophagus 32, at a location between the sphincter 26 and the diaphragm 30. While the outermost layer of the stomach wall 10 (tissue also called the serosa) may be relatively tough and insensitive to mechanical contact with an implant, it has been observed that the tissue forming the outermost layer of the esophagus 32 is more sensitive to contact with an implant, ultimately leading to tissue damage or migration. See the description of FIG. 39 for details about the serosa and the tissue of the esophagus 32. The serosa may also extend to the cardia and may cover the lower portion of the esophagus 32. The serosa has been observed to cover the lower portion of the esophagus 32 up to the sphincter 26, above which there may be no serous layer outside the esophagus. The exemplary embodiment shown in Figures 18C-J is provided to illustrate a beneficial placement of the device to reduce impact on the non-serosa-covered portion of the esophagus 32. The device 100, which may be configured to be positioned to at least partially encircle the esophagus 32, may be formed, for example, as a gastric band similar to those disclosed above. Preferably, the band of the device 100 is positioned so as not to contact or touch the exterior of the esophagus 32, at least in the upper region not covered by the tougher serosal layer that also covers the exterior of the stomach 10. This is achieved by providing or positioning the device 100 with an internal width d1, d2, or diameter that increases in a direction away from the gastric / cardiac notch. Thus, the width d1 may be smaller near the sphincter 26 so that the device 100 can exert supportive or contractile pressure on the sphincter 26, and may increase to a larger width d2 toward the diaphragm 30 to reduce the risk of the device 100 touching or exerting substantial pressure on the exterior of the esophagus 32. As shown in the figure, device 100 can extend along a height h when implanted, allowing the device to contact diaphragm 30, thereby acting as a stop to prevent the cardia from sliding toward and possibly through the diaphragmatic opening.The increase in the inner width d1, d2 of the device can also be described as the inner surface of the device being angled relative to or away from the outer wall of the esophagus 32. The increasing width is indicated in Figure 18C by angle α, which indicates the difference between the inner surface of the device 100 and the outer surface of the esophagus 32 in the direction toward the diaphragmatic opening.

[0163] In other embodiments, a portion of device 100 may include a convex portion having a radius R that is positioned at the cardia, i.e., sphincter 26, and configured to contact or rest against the serosal layer of the cardia. Additionally, a concave portion of radius R' may be positioned facing the esophagus 32, such that a gap or space is formed between the concave surface of device 100 and the esophagus 32. Similar to FIG. 18C, device 100 may have a height h that allows device 100 to contact or abut diaphragm 30 when properly placed in a patient.

[0164] Further, in one example, device 100 can conform to a cylinder having a substantially constant width d1, d2 that is greater than the outer width of esophagus 32. This configuration allows the device to be positioned around or at least partially surround esophagus 32 and (due to its height h) provide a mechanical stop against the diaphragm, preventing sphincter 26 from migrating toward and possibly through diaphragm 30. This advantageously reduces the risk of device 100 contacting the sensitive, non-serosa-covered tissue of esophagus 32 and potentially damaging esophagus 32 during prolonged placement.

[0165] The device 100 described in the above figures, such as Figures 18C-E, can be formed as a substantially cylindrical band or sleeve that can be placed around the esophagus 32. Some examples are shown in Figures 18F-J, having a lower width d1 (adapted for placement at the cardia) and an upper width d2 (adapted for placement at or closer to the diaphragm 30). The cylindrical shape can have a substantially uniform cross-section, as shown in Figures 18E and 18G, or can have a conical cross-section that widens, as shown in Figures 18C and 18F.

[0166] The device 100 depicted in the figures above may, in some embodiments, comprise multiple bodies 102 surrounded by or at least partially secured to retention means 104, 105, such as elastic or flexible members, configured to hold the bodies 102 in their intended position within the device. As shown in Figures 18H-J, the bodies 102 may be elongated, such as ellipsoids or rods, or may be ball-shaped. The bodies 102 may be attached to or held in place by retention means 104, 105, which may be flexible or elastic sheets of a biocompatible fabric or polymer material, such as silicone, or one or more strings or wires 105. In some examples, the retention means 104, 105 form a sleeve configured to be positioned around the lower portion of the esophagus 32 and are flexible to allow at least the lower portion of the device to change width as the patient swallows and the bolus passes through the esophagus 32. The bodies may also have a shape that allows them to be directed away from the esophagus at the top of the implanted device. This can be accomplished by providing the bodies with an esophagus-facing surface that curves or tapers away from the esophagus as it moves upward from the bottom of the implanted device. Additionally, as previously mentioned, the bodies 102 can be magnetic. Magnetic attraction between adjacent bodies 102 can be employed to maintain pressure on the bottom of the esophagus, e.g., the cardia or sphincter 26.

[0167] 19A and 19B illustrate a device 100 according to any of the embodiments shown in FIGS. 14-18 when implanted around the esophagus 20 of a human patient. Preferably, the device 100 can be positioned flush with the sphincter 26 to aid in sphincter contraction. The device 100 can be secured, for example, with sutures or staples, to maintain a desired position in the esophagus 20. Securement, such as with staples or sutures, is temporary; the device 100 may eventually be more permanently secured by fibrous tissue surrounding the device 100. In a further example, the device 100 may be positioned at the junction of the esophagus 20 and stomach 10.

[0168] Device 100 may be configured to exert a surrounding pressure on esophagus 20 to contract esophagus 20, thereby reducing the risk of stomach contents entering esophagus 20. The resilient force within device 100 that contracts elongate core 210 may be generated by elastic means, such as elastic bands or springs, or by magnetic attraction as outlined above, and may be balanced to allow food and liquids to pass through esophagus 20 as the patient swallows, and to allow stomach contents to pass through esophagus 20 as the patient rumbles or vomits.

[0169] The device 100 may further include an electrode array 150 as outlined above to electrically stimulate the sphincter 26 to contract and / or exercise the esophageal 20 musculature to improve long-term placement conditions.

[0170] 20A and 20B illustrate an embodiment of a device 100, which may be configured similarly to the device 100 described above with reference to FIGS. 14-19. The device 100 includes an elongated core 210 comprised of an array of adjacent portions or core elements 213 that can be moved toward or away from each other within the array to vary the length of the elongated core 210. Additionally, the ends 216 of the core 210 are attached to each other to form an annular or ring-like array having a variable circumference and positionable to at least partially encircle the patient's esophagus 20. At least two of the core elements 213 or bodies 213 within the array include respective permanent magnets adapted to attract each other, thereby generating a contractile force within the core 210.

[0171] The core 210 may further include a plurality of links 214 connecting the array bodies 213 to one another. The links 214 may be relatively rigid to provide mechanical support and guide the array bodies 213 as they move toward and away from one another. Thus, the links 214 may be configured to maintain substantially the same shape during operation of the device, i.e., while the elongated core 210 changes between an expanded state and a contracted state. The links 214 may be configured to extend into at least one of the bodies 213 that they interconnect in response to the bodies 213 moving toward one another. As shown in this figure, the bodies 213 may define channels or passages 215 extending therethrough. The channels 215 may be configured to allow end portions of the links 214 to slide back and forth along the channels 215 in response to the core 210 changing its length. The end portions of the links 214 may further include stops or abutments that prevent the links 214 from moving away from the channels 215 and thereby decoupling the array bodies 213 from one another.

[0172] 20A shows the elongate core 210 in a contracted state. In the particular example shown, the elongate core 210 assumes a minimum length (or circumference) defined by the bodies 213 of the array abutting each other. However, it will be understood that the contracted state may be assumed even if the bodies 213 of the array are not touching each other. It may be sufficient if the bodies 213 of the array are positioned closer together than in the expanded state.

[0173] The contracted state may be maintained by an attractive force between adjacent bodies 213 of the array. This force is countered by an expansive force from within the esophagus 20, pushing the bodies 213 of the array apart and causing the elongated core 210 to enter the expanded state. The expansive force may be caused, for example, by the patient swallowing food, taking an abdominal breath, or vomiting. Preferably, the suction force is strong enough to prevent or at least reduce the passage of stomach contents into the esophagus when the patient is not hungry or vomiting.

[0174] FIG. 20B shows the device 100 of FIG. 20A in an expanded state, and in this particular example, a fully expanded state defined by stops 217 at the ends of links 214.

[0175] As with previous embodiments of the device 100, an electrode array 150 may be disposed between the array body 213 and the surrounding tissue when implanted. The electrode array 150 may be comprised of one or several electrode elements 154, for example, disposed on the exterior surface of one of several of the array bodies 213. As with the embodiments described with reference to FIGS. 1-19 , the electrode elements 154 may be configured to operate as cathodes during stimulation, using body tissue as the anode. Alternatively, or additionally, a first one of the electrode elements 154 may be configured to operate as a cathode and a second one of the electrode elements 154 as an anode, with body tissue serving as an electrical conductor for passing an electrical signal between the electrode elements 154. In one embodiment, the electrode array 150 may be configured to provide at least two electrode elements 154 on opposite sides of the sphincter 26 to promote contraction of the sphincter 26.

[0176] The device 100 of FIGS. 20A and 20B may further include a cover 220, which may be configured similarly to the embodiments described, for example, in connection with FIGS. 15-19. One example of such a device 100 is shown in FIG. 21, in which the elongated core 210 of FIGS. 20A and 20B is at least partially surrounded by the cover 220, allowing the core 210 to change between a contracted state and an expanded state without being substantially impeded or inhibited by the presence of fibrous tissue on the outer surface of the cover 220. As with the previous embodiments, an electrode array 150 may be positioned between the cover 220 and the tissue against which the cover 220 rests when implanted. The electrode array 150 may be positioned, for example, on the outer surface of the cover 220.

[0177] A method of implanting device 100 within a patient will now be described with reference to the embodiment shown in Figures 22A, 22B, and 23. This method can be used to secure device 100 in a desired position by tucking or enveloping at least a portion of the device into fundus 12 of stomach 10, and thus can be considered an alternative to the arrangement shown in Figures 19A and 19B, for example, where device 100 is instead positioned to surround the esophagus without tucking or enveloping a portion of fundus 12. Preferably, when implanting a migration restriction device to reinforce fundus 12 and interact with the diaphragm to prevent migration of cardia 22 into the thorax, the following method can be used.

[0178] Preferably, device 100 is positioned relatively high, above the upper border of the lower esophageal sphincter (LES), to improve efficacy against reflux disease symptoms, returning the His angle to its natural anatomical position, and allowing the LES to remain in the abdomen. The method can be divided into a first part, which attaches a portion of the stomach wall 14 to the esophagus 20 to provide a "platform" for positioning device 100 at a desired height, and a second part, which places device 100 in a pouch formed outside the stomach fundus or encases it with a portion of the stomach fundus wall.

[0179] 22A, 22B, and 23, in which, after the esophagus 20 has been dissected into the mediastinum, the fundus portion 14 extending away from the angle of His 28 is affixed to the esophagus 20. According to this method, the fundus 14 can be folded toward the esophagus 20 such that the fundus 14 extends upward along the esophagus 20 from the angle of His 28. The fundus 14 can then be secured to the esophagus 20 by fasteners 230 disposed along first and second lines 231, 232. The first and second lines 231, 232 can extend along the esophagus 20 and can be positioned such that the distance between the first and second lines 231, 232 increases with increasing distance from the angle of His 28. The positions of the first line 231 and the second line 232 are shown by dashed lines in Figures 22A and 22B before the fundus 14 is folded against and affixed to the esophagus 20. The fasteners 230 may comprise, for example, staples or sutures, preferably of a non-resorbable type. If the fasteners 230 comprise sutures, the first line 231 and the second line 232 may each comprise a continuous suture.

[0180] The abdominal portion of the esophagus 20 and the fundus 12 of the stomach may be divided into a ventral portion and a dorsal portion by a plane. In this case, the first line 231 can be considered to be disposed on the dorsal side of the plane, and the second line 232 can be considered to be disposed on the ventral side of the plane. In some examples, the first line 231 and the second line 232 may be disposed at an angle of 45 to 75 degrees, e.g., 60 degrees, relative to the plane. In other words, the angle of separation between the first line 231 and the second line 232 may be within a range of 90 to 150 degrees, e.g., 120 degrees. In some examples, the maximum separation between the two lines 231, 232 at their apexes may be approximately 2 to 3 cm, e.g., approximately 2.5 cm. The orientation of the fastener lines can be considered to represent a "V" or "Y," with the lines separating at the top and gradually tapering toward each other toward the His angle 28. Optionally, additional fasteners such as staples or sutures may be provided at the apex of the "V" or "Y" shape. Alternatively, a third line of sutures 233 may be provided between the first and second lines 231, 232.

[0181] In some examples, the method may comprise starting a first line 231 less than 1 cm, e.g., about 0.5 cm, above the angle of His, and starting a second line 232 less than 3 cm, e.g., about 2 cm, above the angle of His. Preferably, the second line 232 starts less than 2 cm, e.g., about 1 cm, ventral to the first line 231.

[0182] FIG. 23A shows the stomach 10 of FIGS. 22A and 22B after the fundus wall portion 14 has been affixed to the esophagus 20 according to the method outlined above. This method can then be followed by implantation of a device 100, such as a migration restriction device as shown in FIGS. 1-11. The device 100 may be positioned relatively high on the exterior of the fundus wall 12 and invaded or covered by stomach tissue. This can be achieved by forming a pouch or recess 240 in the fundus 12, placing at least a portion of the device 100 in the pouch or recess 240, and at least partially closing the pouch or recess with fasteners 242, as shown in FIGS. 23B and 23C. Preferably, the device 100 is positioned such that the top of the device 100 is positioned a distance from the LES that exceeds the overall height of the device 100 to reduce the risk of the LES sliding through the diaphragm opening 32. Alternatively, the top of the device may be positioned further down, for example, more than half the overall height of the device 100 from the LES. Placing the device further downward increases the risk of the LES slipping into the thorax, potentially causing the device 100 to malfunction.

[0183] Preferably, the device 100 is positioned relatively close to the esophagus 20 so that the distance between the device 100 and the esophagus 20 is determined primarily by the thickness of the doubled stomach wall 14 disposed between the device 100 and the esophagus 20. This distance may be, for example, less than 2 cm, e.g., less than 1.5 cm, depending on the thickness of the stomach wall 14.

[0184] Several examples of devices for treating reflux disease in human patients will now be described with reference to Figures 24-27. Device 100 can be configured to operate by a combination of restricting movement of the cardia toward the diaphragm, e.g., as described with reference to Figures 1-11, and electrical stimulation to contract sphincter muscle 26, e.g., as disclosed with reference to Figures 3 and 14-20, and / or applying surrounding pressure to esophagus 20 to prevent gastric contents from ascending up through esophagus 20, as described with reference to the examples of Figures 14-20. 24-27 may include a first implantable portion 110 (also referred to as a migration limiting device) configured to at least partially surround the esophagus 20 and positioned to rest against the fundus wall 14 of the patient's stomach 10 and having a shape and size that enables it to be positioned to be at least partially invaded or covered by the fundus wall 14, with the first implantable portion 110 implanted in a position between the patient's diaphragm 30 and the lower portion of the fundus wall 14, such that movement of the cardia 22 of the patient's stomach 10 toward the diaphragm 30 is limited to prevent the cardia 22 from sliding through the diaphragmatic opening 32 and into the patient's thorax. The device may further include a second implantable portion 120 (also referred to as an elongate support device) configured to at least partially surround the esophagus 20. In some embodiments, the second implantable portion 120 can have a variable length to enable the device 100 to be placed in a contracted state to prevent fluid from passing from the stomach 10 up through the esophagus 20, and to be placed in an expanded state to allow food to pass into the stomach 10 in response to the patient swallowing. In some embodiments, the second implantable portion 120 is formed as an elongated support device 120 connected to the first implantable portion 110 (or the movement restriction device) and configured to support the electrode array 150 for placement in the esophagus 20. The support device 120 can be configured with a rigidity such that the position of the electrode array 150 relative to the esophagus 20 is primarily determined by the position and orientation of the movement restriction device 110.

[0185] More specifically, FIG. 24 illustrates device 100 comprising multiple core elements 213 arranged in an array and connected to one another by multiple links 214. At least one of the core elements 213 may be larger than the other core elements 213 in the array and may be configured to form a first implantable portion 110 that is affixed to the gastric fundus 14, for example, invasively or by at least partially covering at least one larger core element 213 with stomach tissue. In this manner, at least one larger core element 213 may form a migration restriction device as described above in connection with FIGS. 1-6 . Smaller ones of the core elements 213 form a second implantable portion 120 and may be positioned to surround at least a portion of the esophagus 20. The second implantable portion 120 may have a variable length, as outlined in the previous examples, to allow device 100 to change between an expanded state and a contracted state. Preferably, the maximum width of a cross-section of first implantable portion 110 across its length may be greater than the maximum width of a cross-section of second implantable portion 120 across its length.

[0186] While first implantable portion 110 may be configured to have a substantially fixed size and shape during operation of the device, second implantable portion 120 may be configured to change its length, and thus contraction of esophagus 20, in response to the patient swallowing and, preferably, borborygmus or vomiting. Thus, second portion 120 may be positionable in an expanded state in which a food bolus may pass through sphincter 26, and a contracted state in which second portion 120 exerts an enclosing pressure on esophagus 20 to help sphincter 26 close or at least contract the passageway of esophagus 20.

[0187] 1 and 14 described above, an electrode array 150 may be positioned between the first portion 110 and the fundus wall portion 14 and / or between the second portion 120 and the esophagus 20. The electrode array 150 may be comprised of one or more electrode elements 152, 154 for electrically stimulating and thereby exercising muscle tissue affected by the implanted device 100 and / or for electrically stimulating and thereby contracting the sphincter muscle 26.

[0188] The composite device 100 shown in FIG. 24 advantageously employs several different mechanisms for addressing reflux symptoms. First, the first portion 110, which acts as a mechanical stop against the diaphragm muscle 30, utilizes technology to prevent the cardia 22 from sliding through the diaphragmatic opening 32 and into the thoracic cavity. Second, the second portion 120, which acts as a constrictor, utilizes technology to assist the closing movement of the sphincter 26 to further improve its closure or contractile function. Third, the electrode array 150 may be employed to electrically stimulate the sphincter 26 to further stimulate contraction.

[0189] FIG. 25 illustrates a device 100 that may be configured similarly to the embodiment described above with reference to FIG. 24 . However, the device 100 may differ in that the second portion comprises an elongated support device 120 similar to that disclosed in FIG. 3 , for example. Thus, the first portion 110 may be positioned to penetrate or at least partially cover the gastric fundus tissue and act as a migration restriction device, while the second portion 120 may comprise an elongated support device 120 attached to the first portion 110 and configured to at least partially surround the esophagus 20, instead of the array of core elements shown in FIG. 24 . Preferably, the support device 110 is configured to support the electrode element 154 in a position that allows electrical stimulation of the muscular tissue of the esophagus 20. In some embodiments, the support device 120 is formed as a band 120 configured to be positioned around at least a portion of the esophagus 20, with first and second ends of the band coupled to the first implantable portion 110. Alternatively, or additionally, the support device 120 may include a rigidity that causes the position of the electrode element relative to the esophagus to be determined primarily by the position and orientation of the movement restriction device. This allows the elongate support device 120, and therefore the electrode element 154, to be positioned and maintained at a desired location in the esophagus 20 without being directly secured to the tissue of the esophagus 20 with sutures, staples, or the like. Instead, the position and orientation of the first portion 110, which is affixed to the fundus 14, can be adjusted until the electrode element 154 is positioned at a desired location.

[0190] FIG. 26 illustrates a device 100 that may be configured similarly to the embodiment of FIG. 25. However, this device 100 may differ in that the first portion 110, which may be configured to function as a movement restriction device 110, may be formed as a ring-shaped segment, such as a segment of a torus as shown in the embodiments of FIGS. 7-11. The function and configuration may be similar to that of the embodiment of FIG. 26, allowing the electrode element 154 to be positioned in the esophagus 20 without being directly attached to the esophagus 20, for example, by suturing or stapling. The first portion 110 may have a curvature that matches the curvature of the esophagus 20, allowing it to be positioned on the fundus side of the esophagus 20 so that the inner curvature of the segment is aligned with the outer surface of the esophagus 20. The first portion 110 may be configured to be positioned directly against the esophagus 20, such as at the angle of His 28, or it may be configured to be attached to the fundus 12 so that fundus tissue is positioned between the first portion 110 and the esophagus 20. The at least partial ring-shaped first portion 110 can advantageously improve the stability of the device 100 when in use, reducing the risk of rotation over time and more securely securing the first portion 110 to the fundus 12.

[0191] FIG. 27 illustrates a device 100 that may be configured similarly to the embodiment of FIG. 26. However, the device 100 may differ in that the second portion 120 may be comprised of multiple core elements 213 arranged in an array and connected to one another by multiple links 214, similar to that described in connection with the embodiment of FIG. 24. Thus, the core elements 213 of the second implantable portion 120 may be positioned to surround at least a portion of the esophagus 20, and the second implantable portion 120 may have a variable length such that the device 100 can change between an expanded state and a contracted state, as outlined in the previous examples. The first portion 110, i.e., the restriction device 110, may be similar to the corresponding portion of the embodiment of FIG. 26.

[0192] 1-13 and 24-27, the device 100 according to the embodiments described above in connection with Figures 1-13 and 24-27 can be implanted in the body and affixed by the gastric fundus in several different ways. As previously described, implantation methods can include placing the first portion 110 (or movement restriction device 110) in a pouch formed in the inner or outer wall of the gastric fundus 12, or at least partially covering the first portion 110 with fundus tissue and affixing the first portion 110 by stomach-to-stomach sutures, before the gastric fundus 12 is affixed to the esophagus 20 and / or diaphragm 30 to place the device 100 in a predetermined or desired location in the body. A further exemplary method will now be described with reference to Figure 28.

[0193] 1-13 and 24-27, the device 100 may be affixed to the fundus such that the first portion 110, also referred to as the migration restriction device 110, is positioned on the fundus side of the esophagus to limit migration of the gastric notch relative to the diaphragm and prevent the cardia from sliding through the diaphragmatic opening and into the patient's rib cage. This may be achieved by a method known as "tunneling," i.e., at least partially wrapping or covering a portion of the device 100 with fundus tissue to form a pouch or cavity open at both ends so that the device can extend through the pouch or cavity. Thus, the method comprises positioning the device 100 so that the movement restriction device 110 is against the outside of the fundus 12, wrapping a portion of the fundus 12 around at least a portion of the movement restriction device 110, and attaching the fundus 12 to the esophagus 20 so that the movement restriction device 110 is located in a position between the diaphragm 30 and the sphincter 26 and so that a portion of the fundus 12 is located between the movement restriction device 110 and the esophagus 20.

[0194] 28 shows device 100, with first portion 110 positioned to rest outside of gastric fundus 12 at a location between esophagus 20 and a portion of gastric fundus 12 that is wrapped around and over at least a portion of first portion 110 and introduced between first portion 110 and esophagus 20. In this embodiment, device 100 is ring-shaped to at least partially surround esophagus 20. The ring-shaped body formed by first and second portions 110, 120 thus defines a lumen through which esophagus 20 extends and through which a portion of gastric fundus 12 can be introduced and secured to esophagus 20. As a result, the structure through which device 100 is secured within the patient's body can be understood as a "tunnel" having first and second openings through which device 100 can extend.

[0195] Alternatively, or additionally, device 100 can be implanted by first affixing a portion of the fundus 12 disposed between the first portion 110 of device 100 and the esophagus 20 to the outside of the esophagus 20 in a manner similar to that described above with reference to FIGS. 22 and 23. In this manner, the portion of the fundus extending from the His angle can be folded upward along the esophagus 20 and secured to the esophagus 20, for example, by fasteners extending along first and second lines arranged such that the distance between the lines increases with increasing distance from the His angle. The first portion 110 of device 100 is then invaded or at least partially covered by the portion of the fundus not secured to the esophagus 20. The resulting structure is understood to be a "tunnel." Device 100 may be secured in position relative to the esophagus 20 by a gastroesophageal fastener (e.g., suture or staple) as shown in FIG. 28, or by a gastrostomach fastener. In some embodiments, additional fasteners may be provided to also secure the fundus 12 to the diaphragm 30 (not shown in FIG. 28).

[0196] While the exemplary device 100 shown in FIG. 28 is a ring-shaped device formed with a first portion 110 and a second portion 120, it will be understood that other configurations of device 100 are possible. The device may, for example, consist of only first portion 110, i.e., without second portion 120, thereby resulting in a movement restriction device 110 similar to that disclosed in, for example, FIGS. 1-6. Alternatively, the device may be formed as an annular torus, as shown in FIGS. 7-13, or may consist of a core and, optionally, a cover, as shown in FIGS. 14-21. In further embodiments, device 100 may be configured similar to the embodiments illustrated with reference to any of FIGS. 24-27.

[0197] Generally, device 100 can be implanted in a patient's body via laparoscopic surgery. By way of example, the method may include inserting a needle or tubular device into the patient's abdomen and filling the abdomen with gas using the needle or tubular device. Next, at least two laparoscopic trocars are inserted into the abdomen, and a camera is inserted into the abdomen through one of the laparoscopic trocars. At least one dissection device is inserted through the laparoscopic trocars and used to dissect the area around the esophagus in the mediastinum. A device is introduced into the abdominal cavity, for example, via one of the trocars, and positioned as described above. Sutures or staples may be used to secure device 100 to the fundus itself (forming the incision) and / or the esophagus, so that the device is secured in a desired position relative to the diaphragm 30.

[0198] Device 100 according to the embodiments described above in connection with FIGS. 1-13 and 24-27 can be positioned at or near the junction between esophagus 20 and stomach 10. The position of device 100 can be secured by wrapping or folding a portion of the fundus 12 over device 100 and affixing the fundus portion to esophagus 20, as shown in FIGS. 29-31 and 33. The location where esophagus 20 meets stomach 10 is sometimes referred to as the angle of His 28 or cardiac notch. This placement allows device 100 to be supported by the junction against a portion of the outer wall of fundus 12 extending from the angle of His, and preferably also against the lower portion of the outer wall of esophagus 20. The outermost layer of the stomach wall may be formed by a serosa, also known as the serosa, which is a smooth tissue membrane wall that generally protects the stomach wall. Due to the protective properties of the serosa, it may be desirable to position device 100 so that it rests against the serosa during implantation. Because the serosa has been observed to also cover a portion of the exterior wall of the esophagus 20 proximal to the stomach 10, it may be desirable to apply the device 100 to the lower portion of the esophagus 20 that is covered by the serosa, while avoiding application of the device 100 to other portions of the esophagus 20 that are not covered by the serosa. This can be achieved, for example, by folding the fundus 12 to place the fundus tissue between the device 100 and the esophagus 20, as shown in Figures 1-3, 7-10, and 28. Alternatively, or additionally, this can be achieved by a device 100 such as the movement restriction device 110 of the previous embodiment of Figures 1-3, 7-10, and 28, having a shape that allows the device 100 to be positioned so that its upper portion faces or tapers away from the esophagus 20. 29-33, the disclosed embodiments of the movement restriction device 110 can have sides that are oriented relative to the esophagus 20, and the curvature of the sides can position the movement restriction device 110 to define a gap between the movement restriction device 110 and the esophagus 20 along at least a portion of the esophagus 20. As shown in the illustrated embodiments, the gap can become larger as the distance from the junction between the esophagus 20 and the stomach 10 increases.In other words, device 100 may be configured with a profile that allows it to be positioned to rest against the lower portion of the esophagus 20, which is made up of the serous membrane, and to be positioned to drop or point away from the esophagus 20 when viewed upward along the esophagus 20, generally toward an area of ​​the esophagus 20 not covered by the serous membrane. Preferably, movement restriction device 110 has a rounded, substantially smooth outer surface suitable for implantation.

[0199] These shape features allow the movement restriction device 110 to be positioned to rest against and be supported by the lowest portion of the esophagus 20, and to extend upward toward the diaphragm 30 while being positioned further up the esophagus 20 and generally avoiding contact with portions not covered by the protective layer of serous membrane. Preferably, the movement restriction device 110 can have an upper portion with an extension large enough that, when positioned in such a position, the movement restriction device 110 acts as a mechanical stop against the diaphragm 30 and prevents the cardia 22 from sliding upward through the diaphragmatic opening 32, thereby reducing the risk of reflux symptoms. Preferably, the movement restriction device 110 can be configured to abut the serosa of the portion of the esophagus 20 that extends below the sphincter 26, leaving a gap on the outer surface of the portion of the esophagus 20 that is above the sphincter 26. By having the upper portion of the movement restriction device 110 extend above the sphincter 26 toward the diaphragm 30, the upper portion of the movement restriction device 110 can be positioned high enough to prevent the sphincter 26 from sliding through the diaphragmatic opening and into the patient's rib cage.

[0200] 30 illustrates a movement restriction device 110 having a lower portion with a curvature that allows the movement restriction device 110 to at least partially follow the circumferential curvature of the esophagus 20. Thus, the movement restriction device 110 can be configured to be positioned at the junction of the esophagus 20 and the stomach 10 and to at least partially surround the lower portion of the esophagus 20, which is generally covered by a serosa. Thus, the movement restriction device 110 can have a C-shaped cross-section along its surface adapted to be positioned along the circumference of the esophagus 20. Similar to the above, the movement restriction device 110 can be oriented further up the esophagus 20, slightly away from the esophagus 20, to define a separation gap between the outer surface of the esophagus 20 (which is generally not covered by a serosa further away from the His angle) and the outer surface of the movement restriction device 110. Thus, the movement restriction device 110 may be configured with at least two different curvatures: a first curvature that follows the circumferential curvature of the esophagus 20, and a second curvature that allows the upper portion of the movement restriction device 110 to drop away from the esophagus 20. The first curvature, adapted to follow the circumferential curvature of the esophagus, may be configured with a radius of curvature that corresponds to or exceeds the radius of curvature of the esophagus 20.

[0201] FIGS. 31A-F illustrate various examples of movement restriction device 110, which may be configured similarly to those described with reference to the embodiment shown in FIGS. 29 and 30. Note that the illustrations are schematic and not necessarily to scale. The actual shape and size of movement restriction device 110 may vary depending on the physiology of an individual patient and may be advantageously adapted accordingly. However, several features are common to all of the examples shown in FIGS. 31A-F. Movement restriction device 110 may have a size and outer curvature that allows it to be positioned to rest against and support the lowest portion of esophagus 20 and / or a portion of the fundus 12 located proximal to esophagus 20 and extend upward toward diaphragm 30, while avoiding contact with or with portions of esophagus 20 located further up and generally not covered by a protective layer of serous membrane.

[0202] FIG. 31A illustrates an example in which the lower portion of the movement restriction device 110 is wider than the upper portion, allowing the lower portion to rest against the angle of His while the upper portion is positioned to define a gap between the movement restriction device 110 and the esophagus, similar to that described with reference to FIG. 29.

[0203] 31B shows a movement restriction device 110 having a curvature that can be positioned to follow the circumference of the esophagus 20 at an angle of His, thereby at least partially encircling the esophagus 20, and a further curvature that allows the movement restriction device 110 to taper away from the esophagus as viewed along its length. This embodiment can be configured similarly to that described with reference to FIG.

[0204] Figure 31C shows the movement restriction device 110 of Figure 31A with an elongated support 117 as shown in Figure 32. The elongated support 117 may be attached to any of the examples of movement restriction device 110 described in the context of this application to further improve attachment of the movement restriction device 110 to the stomach 10 and reduce the risk of the movement restriction device 110 moving or changing position and / or orientation relative to the esophagus 20. The support 117 may be configured to be affixed to the esophagus or the fundus of the stomach, as described below with reference to Figure 32.

[0205] 31D shows a further example of a substantially ball-shaped or spherical movement restriction device 110. In some patients, such a movement restriction device 110 may be positioned at the angle of His so that the top of the movement restriction device 110 does not contact the non-serosa-covered portion of the esophagus 20. This will depend on the anatomy and physiology of the particular patient, as well as the size and curvature of the movement restriction device 110. In some non-limiting examples, the movement restriction device may have a shape that conforms to a sphere having a diameter of 3 cm or more, e.g., 4 cm or more, e.g., 5 cm or more.

[0206] Figures 31E and 31F show a movement restriction device 110 that can have a shape and size similar to the embodiment shown in Figure 31D, except that the movement restriction device 110 can be formed from multiple segments 111 similar to the embodiment shown in Figure 5. The embodiments of Figures 29-31 may further be combined with an electrode array 150 for electrically stimulating and exercising muscle tissue in the tissue against which the movement restriction device 110 rests when implanted, for example, as described above in connection with Figures 1-5.

[0207] FIG. 32 illustrates a device 100 that may be configured similarly to the embodiment described in connection with FIGS. 29-31 , except that this embodiment includes an elongated support 117, i.e., fastener, protruding from the movement restriction device 110. The elongated support 117 may be lever-shaped and oriented to extend along the esophagus 20 and configured to be secured to the fundus 12 to provide additional mechanical support for the movement restriction device 110. The support 117 may be wrapped around the movement restriction device 110 and may be invaded or at least partially covered by tissue of the fundus 12 that is affixed to the esophagus at least partially above the movement restriction device 110. The support 117 may protrude from the movement restriction device 110 at an angle that allows the movement restriction device 110 to be positioned (preferably secured over time) in a position that reduces or avoids direct contact between the movement restriction device 110 and non-serosa-containing regions of the esophagus 20. The support 117 may be folded over or at least partially embedded into the fundus tissue so that the fundus tissue is positioned between the support 117 and the tissue of the esophagus 20 .

[0208] 33 and 34 illustrate an example in which the device 100 according to the embodiment of FIGS. 29-32 is used in combination with a bariatric procedure, such as a sleeve gastrectomy. A sleeve gastrectomy (gastric sleeve) is a surgical weight-loss procedure that reduces the size of the stomach by surgically (often laparoscopically) removing a relatively large portion of the stomach along the greater curvature. In FIG. 34A, the dashed lines demarcate the portion to be resected, and the result is shown in FIG. 34B. According to this example, implantation of the movement restriction device 100 and the sleeve gastrectomy may be performed during the same procedure, and the movement restriction device 100 may be positioned to rest against the angle of His and secured in this position by affixing a portion of the gastric fundus to the esophagus above the movement restriction device 110 before the stomach is reduced along the greater curvature. It may be desirable to place the movement restriction device 110 prior to performing the sleeve gastrectomy to ensure a portion of the gastric fundus 12 large enough to accommodate the movement restriction device 110. 34B shows the result, where the movement restriction device 110 can be encapsulated by the fundus 12 secured to the esophagus 20, forming an enclosure to house the movement restriction device 110. In this way, the encapsulated movement restriction device 110 can form a mechanical stop that prevents the cardia from sliding up through the diaphragmatic opening 32 while the overall volume of the gastric cavity is reduced by the sleeve gastrectomy.

[0209] In cases where the stomach wall, such as the fundus, is not sufficiently large to allow a device according to any of the embodiments of Figures 1-13 and 24-34, particularly a movement restriction device 110 described in connection with any of the previous embodiments, to at least partially penetrate or be covered by the stomach wall so that the device can function as a cardia movement restriction device, an alternative device, as shown in Figures 35-37, can be employed. The device can comprise an implantable movement restriction device 110 and an elongated attachment 117 attached to the movement restriction device and configured to be at least partially eroded by a portion of the wall of the patient's stomach 10. As shown in this figure, the attachment 117 can be configured in a shape and size that allows it to be eroded by the wall portion to prevent rotation of the movement restriction device 110 when implanted. The attachment 117 may be configured to be engaged by the outside of the wall so that the movement restriction device 110 is positioned between the patient's diaphragm 30 and the wall of the stomach 10, away from the patient's esophagus 20, and restricts movement of the cardia 22 of the patient's stomach toward the diaphragm 30 to prevent the cardia from sliding through the diaphragmatic opening 32 and into the patient's thorax. The attachment 117 may also be referred to as a fixator, attachment means, support, etc.

[0210] Thus, a first end of the attachment 117 can be configured to attach to the wall of the stomach 10, and a second end can be configured to attach to the movement restriction device 110. The first end of the attachment 117 can be at least partially invaded or covered by stomach wall tissue and, therefore, can be achieved using a relatively small portion of the outer wall of the stomach 10, compared to invading the entire movement restriction device 110 as described above in connection with the previous embodiment. Therefore, this embodiment allows for the movement restriction device 110 to be positioned to act as a mechanical stop for movement toward the diaphragm 30 even when a relatively limited amount of stomach wall is available, such as may be the case after a gastric sleeve procedure.

[0211] The attachment 117 may be releasably attached to the movement restriction device 110, allowing a surgeon to insert the attachment 117 and movement restriction device 110 as separate items. Once inserted into the patient, the movement restriction device 110 and attachment 117 are assembled into a single unit and affixed to the outside of the stomach 10. The attachment 117 and movement restriction device 110 may be secured to one another by interlocking attachment means, such as a snap fit or a form fit. The attachment 117 may also be attached to the movement restriction device 110 by fastening means, such as threading, such that the movement restriction device 110 is screwed to the attachment 117. However, in other embodiments, the movement restriction device 110 and attachment 117 may be integrally formed as a single unit.

[0212] 35 and 36 illustrate an attachment 117 comprising a first portion 118 and a second portion 119 extending in different directions relative to one another, with the first portion 118 configured to be eroded by a wall to prevent rotation of the movement restriction device 110 about a first axis, and the second portion 119 configured to be eroded by a wall to prevent rotation of the movement restriction device 110 about a second axis different from the first axis. The first and second portions 118, 119 of the attachment 119 may further be curved to conform to the curvature of the stomach. In some embodiments, the first and second portions 118, 119 may be angled relative to one another, e.g., between 60 and 120 degrees, e.g., approximately 90 degrees, such that the movement restriction device 110 is mechanically supported by the stomach wall and movement of the restriction device 110 is prevented in at least two different planes relative to the stomach. The fitting 117 may further include a third portion that is an extension of the second portion 119, and the third portion may be configured to be positioned to protrude from the wall portion when implanted to define a distance between the wall portion and the movement restriction device 110. In one embodiment, the third portion is curved, and the curvature is preferably adjustable, so that the third portion can be positioned away from the esophagus 20 when implanted to reduce the risk of the movement restriction device 110 interfering with and pinching the esophagus 20.

[0213] The adherend 117 can be affixed to the stomach 10 by placing the adherend 117 on the exterior surface of the stomach 10 in a recess or fold that is at least partially closed by stomach-to-stomach sutures or staples. The adherend 117 is thus at least partially covered and mechanically supported by stomach wall tissue. Ultimately, the sutures closing the recess or fold along the adherend 117 may become covered or encapsulated by fibrous tissue, further improving fixation and enabling long-term implantation of the device 100.

[0214] Preferably, the fitting 117 is formed of, or at least comprises an outer surface of, a biocompatible material suitable for long-term implantation within the body. Examples of biocompatible materials include medical-grade metal alloys such as titanium or medical-grade stainless steel. Further examples include ceramic materials such as zirconium carbide, or rigid medical-grade polymer materials such as ultra-high molecular weight polyethylene (UHMWPE) or polytetrafluoroethylene (PTFE), or thermoplastic polyesters such as polylactic acid (PLA). Additionally, the fitting 117 may be comprised of at least one composite material, such as any combination of metal / ceramic and polymer materials, or a polymer material reinforced with organic or inorganic fibers, such as carbon or mineral fibers.

[0215] The fixture 117 may also include an electrode array 150 for electrically stimulating and exercising muscle tissue against which the fixture 117 rests when implanted. The electrode array 150 may be configured and operate similarly to any of the previous electrode arrays 150 described with reference to Figures 1-34.

[0216] As shown in FIGS. 35-37, the movement restriction device 110 can have a rounded shape, e.g., conforming to a sphere, to reduce the risk of potential damage to surrounding tissue. The movement restriction device 117 can be formed of a polymer, or at least the outer surface can be constructed of such a material. The outer surface can further comprise a material for preventing fibrotic tissue growth. The outer surface can be constructed of, for example, a permanent or degradable polymer containing an active agent coated onto the movement restriction device 117. The coating can preferably allow for the gradual release of an anti-fibrotic drug. The eluted drug can then be deposited at the contact point between the movement restriction device 110 and contacting tissue, such as the diaphragm 30, thereby providing targeted drug therapy. Examples of polymers include a blend of polyethylene-vinyl acetate (PEVA) and polybutyl methacrylate (PBMA), and poly(styrene-b-isobutylene-b-styrene), respectively. Further examples include phosphorylcholine and poly(vinylidene fluoride-co-hexafluoropropylene) polymer coatings, respectively.

[0217] FIG. 37B shows the attachment device 118 when secured to the stomach wall 10 with rows of sutures or staples used during the gastric sleeve procedure. In this manner, the stitches forming the sleeve can serve the additional purpose of securing the attachment device 118, thereby reducing the need for additional surgery and interaction with the stomach wall tissue. Advantageously, a support device 130 may be placed at the seam, as shown in FIG. 37C, to further improve attachment to the stomach wall 10. This figure discloses a bar-shaped or flat bar-shaped support device 130. The bar may be formed into a sheet-like body or may have a rounded shape, such as a U-shape as shown in this figure, configured to conform to the outer curvature of the stomach wall. The bar may include multiple through-hole openings 131 through which sutures can be threaded during the gastric sleeve procedure. Thus, the bar may be attached to the stomach wall with the same sutures or staples used to form the gastric sleeve. The bar may also be configured to allow the attachment device 118 to be securely attached to it. In one embodiment, the attachment 118 may be inserted between the bar 130 and the stomach 10 and held in place by sutures or staples that attach the bar to the stomach wall. As shown in the embodiment depicted in the figures, the attachment 118 may have a substantially rod-shaped portion that runs at least partially along the bar 130 and is then configured to bend slightly away from the stomach wall and esophagus 32 to reduce the risk of the movement restriction device 110 attached to the distal portion of the attachment 118 contacting or resting outside the esophagus 32.

[0218] Additionally, the movement restriction device 110 may include an electrode array 150 for electrically stimulating and moving muscle tissue to which the movement restriction device 110 is resting when implanted. The electrode array 150 may be configured and operate as any of the previous electrode arrays 150 described with reference to Figures 1-34.

[0219] The movement restriction device 110 can have a shape and size that allows it to act as a mechanical stop against the diaphragm 30, large enough to prevent the movement restriction device 110 from passing through the diaphragm 30, but small enough not to be pressed against the esophagus 20 and cause a narrowing of the food passage. In some examples, the minimum width of the movement restriction device 110, measured side to side, can be 30 mm or greater, for example 40 mm or greater.

[0220] When implanted, movement restriction device 110 may be supported by a mount 117 secured to stomach 10 such that movement restriction device 110 acts as a mechanical stop against diaphragm 30, thereby preventing cardia 22 from sliding upward toward diaphragmatic opening 32. Preferably, movement restriction device 110 may be positioned relatively close to diaphragmatic opening 32, such as less than 2 cm away from the portion of esophagus 20 that passes through diaphragmatic opening 32, without narrowing the food passage defined by esophagus 20.

[0221] The position of the movement restriction device 110 relative to the diaphragm 30 and / or cardia can be adjusted after the attachment 117 is secured to the stomach 10. This adjustment may be achieved, for example, by the attachment 117 being longitudinally and / or angularly adjustable, and the attachment 117 may be, for example, stretchable and / or bendable along its length. This allows the attachment to be affixed to an area outside the stomach 10 that is suitable or optimal for affixing the attachment 117, and allows the movement restriction device 110 to be subsequently correctly aligned / positioned without having to readjust the attachment of the attachment 117 to the stomach 10.

[0222] The following provides a detailed description of a method and system for electrically stimulating muscle tissue for a device according to any of the embodiments described with reference to Figures 1-37, which may be stationary at the time of implantation. Electrical stimulation may be performed to exercise muscle tissue, thereby improving long-term implantation conditions. Electrical electrodes configured in the described electrical electrode arrays and configurations may be implemented in any of the device embodiments described herein for the purpose of exercising muscle tissue in contact with or mechanically affected by the device.

[0223] The body tends to react to medical implants, both because the implant is a foreign body and because the implant mechanically interacts with the body's tissues. Prolonged engagement or pressure of tissue with the implant can deprive cells of oxygen and nutrients, potentially leading to tissue deterioration, atrophy, and even necrosis. The interaction between the implant and tissue can also result in fibrosis, in which the implant is at least partially encased in fibrous tissue. Therefore, it is desirable to stimulate or motility cells, promote blood flow, and increase tissue resistance to pressure from implanted devices.

[0224] Muscle tissue generally consists of muscle cells joined together by tissues that become myofibrils or smooth muscle, depending on the presence or absence of organized, regularly repeating arrays of myofibrillar contractile proteins called myofilaments. Muscle tissue is further classified into skeletal and cardiac muscle tissue. Skeletal muscle tissue is typically under conscious control and is anchored to bones by tendons. Cardiac muscle tissue is typically found in the heart and is not subject to voluntary control. The third type of muscle tissue is so-called smooth muscle tissue, which is typically neither muscular nor under voluntary control. Smooth muscle tissue is found in the walls of organs, such as the stomach and esophagus.

[0225] Muscle contraction is activated by the interaction of the nervous system and hormones, and different muscle types and regions respond differently to neurotransmitters and endocrine substances.

[0226] Nerves are bundles of nerve fibers called axons, which are extensions of individual nerve cells, or neurons. Axons are electrically excitable by maintaining a voltage gradient across their membrane, providing a common pathway for electrochemical nerve impulses called action potentials. An action potential is an all-or-nothing electrochemical pulse generated by an axon when the voltage across the axon's membrane changes sufficiently large over a short interval. Action potentials travel from one neuron to another by crossing synapses, where messages are converted from electrical to chemical and back again.

[0227] The distal end of the axon, called the axon terminal, contains synaptic vesicles that store neurotransmitters. The axon terminal is specialized to release neurotransmitters into the interface, or junction, between the axon and the muscle cell. The released neurotransmitters briefly bind to receptors on the muscle cell membrane and are then dissociated and hydrolyzed by enzymes within the synapse. These enzymes rapidly reduce the impulse to the muscle, allowing for subtle regulation of the intensity and timing of muscle contraction.

[0228] The action potential of a normal skeletal muscle cell is similar to that of a neuron and is typically around -90 mV. Upon activation, sodium / potassium channels inherent in the cell membrane open, allowing sodium to flow in and potassium to flow out. As a result, the cell membrane reverses polarity, and as sodium enters, the cell membrane voltage jumps rapidly from a resting membrane potential of -90 mV to +75 mV. The muscle action potential lasts approximately 2-4 ms, has an absolute refractory period of approximately 1-3 ms, and has a conduction velocity along the muscle of approximately 5 m / s. This change in polarity, in turn, causes the muscle cell to contract.

[0229] The contractile activity of smooth muscle cells is typically influenced by multiple inputs, including spontaneous electrical activity, neural and hormonal inputs, local changes in chemical composition, and stretch. In contrast, the contractile activity of skeletal and cardiac muscle cells depends on a single neural input. Some smooth muscle cell types can spontaneously generate action potentials, which are usually followed by pacemaker or slow-wave potentials. However, the speed and strength of contraction can be regulated by external inputs from the autonomic nervous system. Autonomic neurons may organize into a series of axon-like bulges, called varicosities, that form motor units throughout smooth muscle tissue. Vesicles are composed of neurotransmitter-containing vesicles that transmit signals to muscle cells.

[0230] The muscle cells mentioned above, namely cardiac, skeletal, and smooth muscle cells, are known to respond to external stimuli, such as electrical stimulation by electrodes. A distinction can be made between nerve-mediated stimulation and direct electrical stimulation of muscle tissue. In nerve-mediated stimulation, the electrical signal can be delivered to nerves at locations distant from the actual muscle tissue, or it can be delivered at the muscle tissue, depending on the accessibility and extensibility of the nerves in the body. In direct stimulation of muscle tissue, the electrical signal is delivered to the muscle cells by electrodes placed directly or in close contact with the muscle cells. However, other tissues, such as fibrous tissue or nerves, may also be present at the interface between the electrode and the muscle tissue, resulting in electrical stimulation of these other tissues.

[0231] In the context of this application, the electrical stimulation discussed in connection with various aspects and embodiments may be provided to tissue in direct or indirect contact with an implantable device, such as a movement restriction device. Preferably, the electrical stimulation is provided by one or more electrode elements disposed at the interface or contact between the device and the tissue. Therefore, in the context of this disclosure, electrical stimulation can be considered a direct stimulation of the tissue, particularly in contrast to stimulation transmitted over distance by nerves, which is referred to as indirect stimulation or neural stimulation.

[0232] 1-37, an electrode array of one or more electrode elements may be positioned in, on, or near tissue to be moved by an electrical signal. Preferably, the electrodes are positioned to transmit electrical signals to portions of tissue that are or may be affected by mechanical forces exerted by the medical implant. Thus, the electrode elements may be considered to be positioned between the implanted device and the tissue against which the device is positioned when implanted.

[0233] During operation of an implantable device or electrode array, electrical signals can cause muscle cells to contract and relax repeatedly. This cellular activity, called motility, may have a positive effect in preventing tissue deterioration and damage. Furthermore, this motility may help tissues withstand pressure and mechanical forces generated by the device.

[0234] The interaction between an implanted electrode element and the tissue it contacts is largely determined by the properties of the interface between the tissue and the electrode element. The active conductive surface of the electrode element (hereafter referred to as "metal," although other materials are equally possible) is either uncoated or insulated with some type of dielectric material to provide a metal-tissue interface. The uncoated metal surface of the electrode element is sometimes referred to as a bare electrode. Because electrical interactions with tissue are transmitted through this interface, the interface between the electrode element and the tissue can affect the behavior of the electrode element. In the biological medium surrounding the electrode element, including actual tissue and electrolytes that may be present at the junction, current is carried by charged ions, while in the electrode element material, current is carried by electrons. Therefore, some mechanism for transferring charge between these two carriers is required to allow continuous current flow.

[0235] In some instances, the electrode element may be bare, exposing the metal to the surrounding biological medium when implanted within or at the muscle tissue to be stimulated. In this case, charge transfer may occur at the metal-electrolyte interface between the electrode element and the tissue. Due to the natural thermodynamic equilibrium between the metal and the electrolyte, a voltage may be established across the interface, which may attract and order ions from the electrolyte. This layer of charged ions on the metal surface is called the "double layer" and may physically account for a portion of the electrode's capacitance.

[0236] Thus, both capacitive and faradaic processes can occur in electrode elements. In faradaic processes, the movement of charged particles across the metal-electrolyte interface is considered the primary mechanism for current transfer. Thus, in faradaic processes, after a certain current is applied, the charge, voltage, and composition of the electrode tend to a constant value. Instead, in capacitive (non-faradaic) processes, charge gradually accumulates on the metal surface, and current transfer is generally limited to the amount that can pass by charging the interface.

[0237] In some examples, the electrode element may be comprised of a bare electrode portion, i.e., an electrode having an uncoated surface portion facing the tissue, such that a conductor-tissue interface is provided between the electrode element and the tissue when the electrode element is implanted. This allows electrical signals to be transmitted to the tissue primarily via a faradaic charge transfer process. Because the faradaic charge transfer process tends to be more efficient than the capacitive charge transfer process, bare electrodes may be advantageous from the perspective of power consumption. Therefore, the use of bare electrodes can increase the current transmitted to the tissue for a given power consumption.

[0238] In some instances, the electrode element may include a portion at least partially covered with a dielectric material to form a dielectric-tissue interface with muscle tissue when the electrode is implanted. This type of electrode element allows electrical signals to be transmitted to muscle tissue primarily capacitively, i.e., non-Faradic. This may be advantageous over the Faradaic processes associated with bare electrodes, as Faradaic charge transfer can be problematic. Examples of problems associated with Faradaic charge transfer include undesirable chemical reactions such as metal oxidation, water electrolysis, saline oxidation, and organic oxidation. Water electrolysis generates gases, which can be damaging. Saline oxidation can produce various compounds, some of which are toxic. Metal oxidation can release metal ions and salts into tissue, which can be dangerous. Finally, organic oxidation in situations where the electrode element is directly stimulating tissue can produce toxic chemical products.

[0239] This can be achieved by using electrodes at least partially covered with a dielectric material, preferably chosen to have as high a capacitance as possible, to restrict the current flowing across the interface primarily capacitively.

[0240] The present disclosure incorporates several types of electrode elements. The electrode element can be, for example, a plate electrode consisting of a plate-shaped active portion that interfaces with tissue. In another example, the electrode can be a wire electrode formed of a conductive wire that can be electrically contacted with tissue. Further examples include needle- or pin-shaped electrodes with a tip that can be attached to or inserted into muscle tissue. The electrode can be, for example, encased in epoxy resin for electrical insulation and protection and constructed of gold wire or contact pads for contacting muscle tissue. Some examples of these electrodes, methods for stimulating with the electrodes, and how they can be positioned in conjunction with implantable devices such as those described in conjunction with the embodiments of Figures 1-37 are described below with reference to Figures 38-45.

[0241] 38A and 38B illustrate embodiments of a device 100, which may be configured similarly to the embodiments described with reference to any of the preceding FIGS. 1-37. Accordingly, FIG. 38A illustrates a device 100 having a migration restriction device 110 configured to be affixed by the fundus 12 to prevent the cardia 22 from sliding upward through the diaphragmatic opening, while FIG. 38B illustrates a device 100 including a portion, such as an elongated core or support device 120, configured to at least partially surround the esophagus 20. The surrounding portion 120 may be configured to assist the sphincter in closing the esophagus, for example, by applying a surrounding pressure and / or by electrically stimulating the sphincter to contract. This embodiment is shown in cross-section as implanted and placed in the fundus 12 (migration restriction device in FIG. 38A) or around the esophagus (contraction / stimulation device in FIG. 38B).

[0242] The device 100 of Figures 38A and 38B further includes an electrode array comprised of multiple electrode elements 152, 154 for electrically stimulating tissue of the fundus 12 and / or esophagus 20 to exercise muscle tissue to improve the long-term implant condition of the device 100, as described above. In the embodiment of Figure 38A, the electrode array is disposed on the exterior of the movement restriction device 110 and is therefore positioned in substantial electrical contact with tissue of the fundus 12 to which the movement restriction device 110 may be invasively or at least partially covered by the fundus wall tissue. In the embodiment of Figure 38B, the electrode array is positioned on the exterior of the core element 213 and in electrical contact with tissue of the esophagus 20. As shown in Figure 38B, the electrode array is comprised of at least two electrode elements 154, positioned on opposite sides of the esophagus 20, capable of contracting the sphincter 26.

[0243] Each of the electrode elements 152, 154 of the electrode array may be connected to a controller, such as a stimulation control device 170, by an electrical conduit 172. The controller 170 may be configured to be operatively connected to the electrode array to control electrical stimulation of tissue. In the embodiment shown in FIG. 38A, the controller 170 may be configured to control the electrical stimulation such that muscle tissue of the fundus 12 is stimulated with a series of electrical pulses. In the embodiment shown in FIG. 38A, the pulses may comprise a pulse of a first polarity followed by a pulse of a second, opposite polarity, and the generated pulsed electrical stimulation signal may comprise a pulse frequency of 0.01-150 Hz. In the embodiment shown in FIG. 38A, the electrical stimulation signal may include a pulse duration of 0.01-100 ms and a pulse amplitude of 1-15 mA. More specifically, in the embodiment of FIG. 38A, the electrical stimulation signal may comprise a pulse frequency of 0.15-0.25 Hz, a pulse duration of 20-30 ms, and a pulse amplitude of 3-10 mA. Further, in the embodiment of FIG. 38A, the electrical stimulation signal may include a build-up period of 0.01 to 2 seconds with gradually increasing amplitude, a stimulation period of 1 to 60 seconds, and a rest period of 0.01 to 60 seconds, and the electrical signal has a pulse frequency of 1 to 50 Hz and a pulse duration of 0.1 to 10 ms.

[0244] 38A may be integrated into an implantable controller, and the stimulation controller may be configured to receive input from a wireless remote controller, either directly or via a receiver in the implantable controller, to program stimulation routines for controlling stimulation or exercising muscle tissue to improve the long-term implant condition of the implantable movement restriction device 110. Programming of stimulation routines may be, for example, programming the frequency of stimulation or programming the current and / or voltage of stimulation.

[0245] Figure 38B shows an embodiment of the implantable device 110 in which the electrode elements 154 are connected to a stimulation control device 170 configured similarly to that described with reference to Figure 38A. The controller 170 can therefore be configured to be operably connected to the electrode array to control electrical stimulation of tissue in the esophagus 20. Stimulation of the tissue can be performed, for example, with electrical pulses as described with reference to Figure 38A, or can be controlled as a continuous low-energy current that provides continuous stimulation to the sphincter 26.

[0246] 38A and 38B, and preferably in the movement restriction device 110, the implantable device 110 may further include an implantable sensor 180 configured to sense action potentials generated by pacemaker cells in the tissue of the stomach wall. The implantable sensor 180 may also be connected to the controller 170 by a sensor lead 173. The controller 170 may be configured to control the electrical simulation based at least in part on the sensed action potentials and may be configured to generate electrical pulses that amplify the sensed action potentials. The implantable sensor 180 may be implemented in any of the embodiments of the implantable device 100 for treating reflux disease as disclosed herein.

[0247] As described above in connection with the embodiment shown in Figures 1-38, the device can be implanted within the body to interact with different portions of the stomach and / or esophagus. A first portion 110 of the device can be affixed to the fundus 12, for example, to function as a migration restriction device, while a second portion 120 of the device 100 can be positioned to at least partially surround the esophagus 20 to help prevent stomach contents from ascending up the esophagus 20.

[0248] Figure 39 is a schematic cross-sectional view showing the general anatomy of a healthy adult stomach. The stomach is located in the patient's abdomen, below the diaphragm 30. It enters through an opening 32 in the diaphragm 30, the esophagus 20, a fibromuscular tube approximately 25 cm long that passes from the rib cage to the abdomen. The lower portion of the esophagus 20 is called the abdominal portion of the esophagus 20. The esophagus 20 can connect to the stomach via a short segment, usually less than 1 cm, called the cardia 22. Therefore, the cardia 22 can be considered to form the junction or interface between the esophagus 20 and the stomach 10, and may be formed by both a portion of the esophagus 20 and a portion of the stomach. The cardia 22 may join the greater curvature of the stomach (to the right in the illustration) at the cardiac notch 24, which forms an acute angle between the esophagus 20 and the upper stomach wall. The cardiac notch 24 is also called the angle of His. Typically, this angle is approximately 75 degrees in healthy adults. Figure 39 also illustrates a sphincter 26, which may be located in the wall of the cardia 22. Functionally, the sphincter opens to allow food to enter the stomach and quickly closes to prevent stomach contents from refluxing into the esophagus. The fundus 12 forms in the upper curved portion of the stomach and may be located above the cardiac notch 24. It typically stores gas generated during digestion rather than food. The empty stomach volume of a healthy adult is approximately 50 ml, and the fundus 12 generally occupies a relatively small portion of that volume. The outermost layer of the stomach wall is called the serosa 14. It is approximately 1–2 mm thick, compared with the 3–4 mm thickness of the entire stomach wall. The serosa also extends to the cardia 22 and may cover the lower portion of the esophagus 20. The serosa has been observed to cover the lower portion of the esophagus 20 up to the sphincter 26, although above that, the outer esophagus may lack a serous layer.

[0249] FIG. 40A illustrates an example of a bipolar electrode array 150, consisting of first and second electrode elements 152, 154, which may be configured similarly to the electrode elements described with reference to any of the previous embodiments. In the following figures, the first and second electrode elements are distinguished by the reference numerals E1 and E2, respectively. The first and second electrode elements E1, E2 may be connected to different electrical potentials. Thus, the first electrode element E1 may operate as an anode, and the second electrode element E2 may operate as a cathode. However, in alternative embodiments, both electrode elements E1, E2 may operate as cathodes, while body tissue is used as the anode. The electrode elements E1, E2 may be attached directly to the exterior surface of the implantable device, as disclosed with reference to FIGS. 38A and 38B. In some examples, the electrode elements E1, E2 may be disposed on a support, such as a flexible patch, which may be configured to be attached to an implantable contraction device. Electrode array 150 can be positioned between the implantable contraction device and tissue (as disclosed with reference to FIGS. 38A and 38B ) and in some embodiments can be provided as a separate, physically distinct item, while in other embodiments can be incorporated into device 100. Electrode array 150 may include one or more contact pads to increase the contact surface between the electrodes and tissue when implanted. In operation, electrical signals are supplied to muscle tissue by first and second electrode elements E1, E2 to stimulate contraction of muscle cells.

[0250] 40B shows another example of an electrode array 150, which in this example may be unipolar electrode elements 152, 154. Electrode element E1, for example, may act as the cathode when implanted. Electrode element 152 may be formed of a flattened, coiled wire to increase the contact surface between electrode element 152 and tissue. Furthermore, the coiled configuration allows for a certain degree of mechanical flexibility of electrode element 152 so that it can conform to muscle tissue during contraction and relaxation.

[0251] 40C shows the distal end of a needle- or pin-shaped electrode array 150, in which the active portions of the electrode elements 152 are provided as bare electrode surfaces 155 at the distal ends of the electrode elements 152 and protrude from an insulator 156 covering the remainder of the electrode elements 152. Thus, when implanted in muscle tissue, the active bare electrode surfaces 155 of the electrode elements 152 can form a metal-tissue interface with the muscle tissue, which can surround the ends of the electrode elements 152 to provide a relatively large contact surface. This embodiment is advantageous in that it can be inserted into tissue, thereby allowing selective stimulation at a certain depth of the tissue.

[0252] Figure 40D shows an electrode element 152 similar to Figure 40C, except that the electrode element 152 comprises an active portion covered with a dielectric material 157 to protect the electrode material from degradation and to facilitate capacitive current transmission. The dielectric material 157 may be, for example, electrochemically deposited tantalum oxide, which allows charge to pass through the interface while reducing the risk of electrode corrosion, gas formation, and metabolic reactions.

[0253] It will be appreciated that both faradaic and capacitive mechanisms can exist simultaneously, regardless of the type of electrode used. Thus, capacitive charge transfer exists for bare electrodes that form a metal-tissue interface, and faradaic charge transfer exists for coated electrodes that form a dielectric-tissue interface. It has been found that shortening the pulse duration of an electrical signal can reduce or eliminate the faradaic portion of the current delivered to muscle tissue. Shortening the pulse duration has been found to be an efficient way to increase the portion of the signal that can pass through the interface as capacitive current, rather than faradaic current. As a result, shorter pulses can cause less damage to the electrode and tissue.

[0254] The capacitive portion of the current can be further increased relative to the faradaic portion by decreasing the amplitude of the current pulse of the electrical signal, which can reduce or inhibit chemical reactions at the electrode-tissue interface, thereby reducing potential damage caused by compounds and ions generated by such reactions.

[0255] As an example, electrical stimulation can be controlled such that a positive pulse of the electrical signal is followed by a negative pulse (or, stated differently, a pulse of one polarity followed by a second pulse of the opposite polarity), preferably of the same amplitude and / or duration. Advantageously, the subsequent negative (or reverse) pulse can be used to reverse, or at least moderate, the chemical reaction or changes that occur at the interface in response to the first positive pulse. Generating a reverse pulse can reduce the risk of electrode and / or tissue degradation at the electrode-muscle tissue interface.

[0256] FIG. 41 illustrates an example of a pulsed electrical signal applied to an electrode for electrically stimulating muscle tissue through the electrode-tissue interface, as described above. The electrical signal can be generated by a stimulation control device located outside the body (as described with reference to FIGS. 38A and 38B ) or by a stimulation control device implanted within the body. A stimulation control device 170 may be operably connected to the electrode elements 152, 154 by leads 172, and the electrical signal shown in this figure may reflect either a signal generated by the stimulation control device 170 or a signal delivered to the electrode elements 152, 154 at the electrode-tissue interface. The characteristics of the electrical signal can be selected and varied based on the electrical properties of the electrode-tissue interface and the actual response of the tissue. The electrical stimulus provided to muscle cells may depend on several factors, including the configuration and placement of the electrode elements 152, 154 in the tissue, the presence of fibrous material at the interface, the composition of the electrolyte at the interface, and the accumulation of non-conductive material on the electrode surface. Therefore, it is proposed to select and vary the characteristics of the electrical signal, such as those shown in this figure, based on the observed or estimated response from the stimulated tissue.

[0257] In this embodiment, the electrical signal is a pulse signal consisting of square waves PL1, PL2, PL3, and PL4. However, pulses of other shapes may be employed. The pulse signal may be periodic, as shown, or may be intermittent (i.e., a series of multiple pulses separated by periods without pulses). The pulses may have an amplitude A measured in volts, amperes, etc. Similarly, if the signal is periodic, the pulse signal has a period F corresponding to the frequency of the signal. Furthermore, the pulses may be either positive or negative relative to a reference.

[0258] The pulse frequency may be, for example, within the range of 0.01 to 150 Hz. More specifically, the pulse frequency may be within at least one of the ranges of 0.1 to 1 Hz, 1 to 10 Hz, 10 to 50 Hz, or 50 to 150 Hz. It has been observed that relatively low pulse frequencies can be employed to mimic or enhance the slow wave potentials associated with pacemaker cells in smooth muscle tissue. Therefore, for such applications, it may be advantageous to use relatively low pulse frequencies, such as 0.01 to 0.1 Hz, frequencies below 1 Hz, or even a few Hz.

[0259] The pulse duration may be, for example, 0.01 to 100 milliseconds, e.g., 0.1 to 20 milliseconds (ms), preferably in the range of 1 to 5 ms. Some studies have observed that natural muscle action potentials are approximately 2 to 4 ms, so it may be advantageous to use a pulse duration that mimics that range.

[0260] The amplitude may be in the range of 1 to 15 milliamperes (mA), with some studies showing particularly good muscle contraction responses in the range of 0.5 to 5 mA.

[0261] In a preferred embodiment, electrical stimulation is performed using a pulse signal with a pulse frequency of 10 Hz, a pulse duration of 3 ms, and an amplitude of 3 mA.

[0262] Figure 42 shows an example of a pulse signal, consisting of a build-up period X1, during which the amplitude gradually increases; a stimulation period X2, during which the muscle tissue is exposed to the contraction stimulation signal; a ramp-down period X3, during which the amplitude gradually decreases; and a stimulation pause period X4 before a new build-up period begins. The build-up period can be, for example, 0.01 to 2 seconds, the stimulation period 1 to 60 seconds, the ramp-down period 0.01 to 2 seconds, and the stimulation pause period 0.01 to 60 seconds. The pulse frequency can be, for example, 1 to 50 Hz, the pulse duration 0.1 to 10 milliseconds, and the amplitude during the stimulation period 1 to 15 milliamperes. Stimulation of skeletal muscle tissue can be performed using, for example, a 50 Hz pulse with a 100-microsecond duration. The current amplitude can be 1, 2.5, 7.5, or 10 mA. In particular, the desired muscle contractile response has been experimentally observed in the range of 0.5 to 5.0 mA. In this example, a coiled electrode can be used as the cathode. Another design example is a multi-stranded wire arranged in a helical configuration. They are implanted in the muscle wall of the stomach fundus (or esophagus) and can be stimulated with any desired pattern, e.g., biphasic pulses, 10-40 Hz, duration 0.1-5 ms, current density 3-5 mA / cm. 2 It can be said that:

[0263] 43 is a schematic diagram of a system for electrically stimulating or exercising muscle cells to increase the tissue's resistance to pressure from a device 100. The system can be used in conjunction with, and in some instances configured within, an implantable device 100. The system can be comprised of an electrode array 150, which can be configured similarly to the electrode array / electrode elements described above in connection with the previous examples, an energy source 160 for providing the electrical energy necessary to generate the electrical signal, and a stimulation controller 170 for controlling the generation of the electrical signal.

[0264] The electrode array 150 can be comprised of one or several electrode elements 152, 154, such as bare electrodes or electrodes at least partially covered with a dielectric material 157 as shown in FIG. 39d, and can be configured to be implanted in or engage the muscle tissue to be stimulated to form an electrode-tissue interface through which a stimulation signal is delivered. Alternatively, or additionally, the electrode elements 152, 154 can be positioned in proximity to the muscle tissue such that an electrical coupling is established between the electrode elements and the muscle tissue, for example, when other tissue, such as connective tissue, is present between the implanted device and the muscle tissue.

[0265] The electrodes may be electrically connected to the energy source 160, for example, by wires or leads 172, such that an electrical signal is transmitted to the electrode-tissue interface. In some examples, the electrodes 152, 154 may be integrated with or attached to a device, such as the movement restriction device 110, such that when implanted in a patient, the electrodes 152, 154 are positioned at the interface between the device 100 and muscle tissue. This allows the electrodes 152, 154 to be used to exercise muscle tissue that is mechanically influenced by the implanted device.

[0266] Energy source 160 may be a non-rechargeable type, such as a primary battery, or a rechargeable type, such as a secondary battery. Energy source 160 may be rechargeable from outside the body by energy transmitted from an external energy source, or may be surgically replaceable. Furthermore, electrode array 150 may be operatively connected to stimulation controller 170, which may comprise an electrical pulse generator, to generate electrical pulses. Stimulation controller 170 may be integrated with energy source 160, configured for implantation within the body, or provided as a physically separate unit configured for operation from outside the body. In the latter case, it may be advantageous for an external control unit to be able to wirelessly communicate with stimulation controller 150.

[0267] According to some embodiments, the system may include a sensor S1 configured to sense a physical parameter of the body and / or device 100. Sensor S1 may be employed to sense or detect a bodily response to an electrical stimulus, such as, for example, a contraction of stimulated muscle tissue. As an example, sensor S1 may be configured to sense an action potential delivered to the muscle tissue. The action potential may be generated, for example, by pacemaker cells in the muscle tissue, and may be registered by sensor S1 and transmitted to stimulation controller 170. Stimulation controller 170 may use the received signal in controlling energy source 160 such that the generated electrical signal amplifies the sensed action potential.

[0268] The energy source 160 may preferably be an implantable energy source 160 configured to be placed inside the patient's body. Preferably, the implantable energy source 160 may comprise a secondary battery that can be charged externally to reduce the need for surgical battery replacement procedures. As shown in the figure, the implantable energy source 160 may be configured to receive electrical energy from an external energy source 165 located outside the body. In such an example, the system may further include an implantable charger 190 electrically connected to the implantable energy source 160 and configured to enable charging of the implantable energy source 160 by the external energy source 165. The implantable charger 190 may be configured to be electrically connected to the implantable energy source 160 by, for example, wires or leads 172 so that electrical energy can be transferred from the implantable charger 190 to the implantable energy source 160. The implantable charger 190 may further be connected to the external energy source 165 by a wireless connection or by a wired connection using wires or leads 172, which may be similar to those between the charger 190 and the implantable energy source 160. In the latter case, the wires or leads 172 may terminate in terminals accessible to the patient's skin, either as contact ports on the surface of the skin or located beneath the skin. For example, electrical energy may be transferred to the charger 190 by connecting the external energy source 165 to the port by making an incision in the skin to expose the port and allow the external energy source 165 to be inserted.

[0269] Alternatively, the implantable charger 190 may be configured to receive energy wirelessly, e.g., inductively, from the external energy source 165. In this case, the charger 190 may include an electromagnetic coil configured to wirelessly receive power from the external energy source 165. The charger 190 may be placed subcutaneously, for example, to facilitate inductive transfer of energy through the patient's skin.

[0270] Charging of the implantable energy source 160 can be controlled according to several different schemes. In one example, charging of the implantable energy source 160 can be controlled by controlling the reception of power from an external energy source at the implantable charger 190. Stated differently, the charger 190 may be configured to vary or control its ability to receive electrical energy from the external energy source 165. Thus, the amount of power supplied to the implantable energy source 160 can be regulated at the implantable charger 190 rather than at the external energy source 165, thus permitting transmission of a substantially constant power. By varying the reception of power at the charger 190 rather than the transmission of power at the external energy source 165, charging of the implantable energy source 160 can be performed without sending control signals to the external energy source 165. Instead, the intelligence required to regulate and control charging of the implantable energy source 160 can be contained within the patient's body without the need for communication outside the body.

[0271] In alternative embodiments, charging of implantable energy source 160 may be controlled by controlling the transmission of power in external energy source 165. Thus, charger 190 (or any other component of the device / system placed inside the body) can send transmission commands, e.g., via control signals, to external energy source 165, which can adjust its transmission power accordingly.

[0272] Charging of the implantable energy source 160 may be controlled by the controller 170, which may therefore be configured to issue control commands to the implantable charger 190 and / or the external energy source 165, as described above. In some examples, the controller 170 may be configured to indicate a functional status of the implantable energy source 160, such as, for example, the charge level, charge capacity, voltage, and / or temperature of the implantable energy source 160. The functional status may be used, for example, to control charging of the implantable energy source 160, as described above, and to indicate the status of the implantable energy source 160 to another external entity, such as the patient or medical staff. The functional status may be transmitted, for example, outside the body, where it may be interpreted and used to diagnose the condition / status of the implanted device. Additionally, the functional status may be transmitted outside the body to provide a warning signal, for example, indicating a low battery or overheating. Transmission of signals to / from the controller 170 is described in further detail below in connection with Figures 44-48.

[0273] The functional status may be based on signals from sensors, such as, for example, a temperature sensor configured to sense the temperature of the implanted energy source 160, or an ammeter or voltmeter configured to measure the electrical status of the implanted energy source 160. The sensor output may be transmitted, for example, by wires or electrical conductors 172, to the controller 170, where it may be processed and acted upon in the form of an issued signal containing control instructions and / or functional status information for the charger 190 / external energy source 165.

[0274] The functional status may in some instances be transmitted externally via a carrier signal by a transmitter that may be placed, for example, subcutaneously, or may be built into the charger 190.

[0275] FIG. 44 illustrates an embodiment similar to the system described above with reference to FIG. 43. However, as shown in this figure, the system may further include an external signal transmitter 175, such as a wireless remote device 175, which may be configured to be operably connected to the controller 170. The external signal transmitter 175 may be positioned to allow the patient or another external device, such as a service technician or medical staff, to interact with the controller 170. The external signal transmitter 175 may be used to control or adjust the operation of the implanted controller 170, for example, to affect or adjust the electrical stimulation signal delivered to tissue by the electrode array 150. External control of the controller 170 may serve, for example, to increase or decrease the amplitude or frequency of the electrical stimulation signal or to activate / deactivate electrical stimulation. In one example, the external signal transmitter 175 may be used to increase electrical stimulation of the sphincter in response to experienced reflux symptoms. In this way, the patient may increase sphincter contractions to further prevent stomach contents from ascending in the esophagus.

[0276] The signal that the external signal transmitter 175 communicates with the implant control device 170 may be selected from the group consisting of sound signals, ultrasound signals, electromagnetic wave signals, and infrared signals, visible light signals, ultraviolet signals, laser signals, microwave signals, radio wave signals, x-ray radiation signals, and gamma ray radiation signals.

[0277] Although shown as separate components / entities in the figures, it will be understood that the implantable or internal controller 170 may be integrated into the implantable charger 190 and / or the implantable energy source 160. Additionally, the external signal transmitter 175 may be integrated into the wireless remote device.

[0278] Figure 45 is a schematic diagram of a system or device that may be configured similarly to the systems described with reference to Figures 43 and 44. Thus, a system is disclosed that includes an electrode array 150 for exercising muscle tissue affected by an implantable device according to any of the embodiments described above in connection with Figures 1-37, and a controller 170 configured to be operatively connected to the electrode array 150 for controlling electrical stimulation of the muscle tissue. The controller 170 may be coupled to an implantable energy source 160 for powering the electrode array in accordance with a stimulation signal or pattern generated by the controller 170.

[0279] FIG. 45 further illustrates an implantable communication unit 171, which may be configured to transmit signals between the controller 170 and outside the patient's body, similar to that described above in connection with FIG. 44. The communicator 171 may be integrated into the controller 170 or may be provided separately. Thus, the communication unit 171 may be used to transmit signals configuring the functional status of the implantable energy source 160 and to communicate with an external controller 176 used to control or regulate the operation of the implantable controller 170. The external controller 176 may be configured, for example, within a remote controller 175 as shown in FIG. 44.

[0280] The implantable control device 170, also referred to as an internal controller or stimulation control device 170, may be understood as any implantable unit capable of controlling electrical stimulation of tissue. The control device may include an electrical signal generator, modulator, or other electrical circuitry capable of delivering electrical stimulation signals to the electrode array. Furthermore, the control device may process control signals and generate electrical stimulation signals in response thereto, as well as generate control signals for controlling other components of the system or device, such as the implantable energy source 160 and / or the implantable charger 190. Thus, a control signal may be understood as any signal capable of conveying information and / or power such that a component of the system / device can be directly or indirectly controlled.

[0281] The control device may comprise a processing unit, such as a CPU, for handling control of the electrode array 150 and other components of the system. The processing unit may be a single central processing unit or may comprise two or more processing units. The processing unit may be a general-purpose microprocessor and / or an instruction set processor and / or an associated chipset and / or a special-purpose microprocessor, such as an ASIC (application-specific integrated circuit). The processing unit may also comprise memory for storing instructions and / or data. The controller 170 may be adapted to track different stimulation patterns and durations used to stimulate muscle tissue, as well as action potentials sensed by the sensor S1 in some examples. The controller 170 may further include a communicator, or communication unit 171, as outlined above, which may be configured to receive and / or transmit wireless or wired signals to / from outside the body. The communication unit 171 may allow the controller 170 to be programmed from outside the patient's body so that the operation of the electrode array 150 can be programmed for optimal function.

[0282] The controller 170 and other implanted components, such as the energy source 160, the charger 190, and the first or second portions 110, 120 of the device 100, may be surrounded by a housing to protect the components from bodily fluids. The housing may be made from one or a combination of carbon-based materials (such as graphite, silicon carbide, or carbon fiber materials), boron-based materials, polymeric materials (such as silicon, Peek, polyurethane, UHWPE, or PTFE), metallic materials (such as titanium, stainless steel, tantalum, platinum, niobium, or aluminum), ceramic materials (such as zirconium dioxide, aluminum oxide, or tungsten carbide), or glass. In either case, the housing should be made from a material with low permeability so that fluid movement through the housing walls is prevented.

[0283] 46 illustrates a patient's stomach S (also referred to as stomach 10 in the upper figures) when device 100 according to the embodiment described with reference to the previous figures is at least partially positioned around esophagus E (also referred to as esophagus 32 in the upper figures). Device 100 can be operated by electrical leads 135 that travel inside protective covers 136a, 136b, which are coupled to a single protective cover for guiding electrical leads 135 to remote unit 140, i.e., control unit 140, for remote operation of device 100. This operation may involve, for example, electrical stimulation and movement of muscle tissue to which device 100 is stationary, as previously described.

[0284] In the embodiment of FIG. 46, the control unit comprises first and second portions 141′, 141″ that are positioned on different sides of a portion of the patient's muscle tissue MT and connected by a connector positioned through a hole in the muscle tissue MT. The second portion 141″ is positioned inside the muscle tissue MT, and the first portion 141′ is positioned outside the muscle tissue MT within the subcutaneous tissue ST. In the embodiment shown in FIG. 46, the control unit 300 is positioned in the second portion 141″ and the implantable energy storage unit 40 is positioned in the first portion 141′. The control unit 300 and the implantable energy storage unit 40 are electrically connected by leads running within the connecting portions so that electrical energy and communications can be transferred from the second portion 141″ to the first portion 141′ and vice versa. In the embodiment of FIG. 46 , the first portion 141′ further comprises a wireless energy receiver 305 for receiving wireless energy for charging the implantable energy storage unit 40 and / or powering the medical device, and a transceiver 308 for receiving and / or transmitting wireless signals to and from outside the body. The implantable energy storage unit 40 may be any type of energy storage unit suitable for implantation, such as a rechargeable battery or a solid-state battery such as a thionyl chloride battery. The energy storage unit may include an energy storage unit indicator configured to indicate a functional status of the implantable energy storage unit. The functional status may indicate at least one of a charge level and a temperature of the implantable energy storage unit 40. To enable an indication of the temperature of the energy storage unit 40, the energy storage unit 40 or the medical device 100 may include a temperature sensor.

[0285] The controller 300 may include or be configured to receive sensor input from at least one sensor. The sensor may be a sensor configured to sense a physical parameter of the medical device system, such as at least one of:

[0286] The temperature of the medical device system is monitored to prevent excessive heating of tissue connected to the medical device during operation of the medical device or charging of the energy storage unit 40. Excessive heating may also damage the medical device and / or the energy storage unit 40. Excessive heating may also be an indicator that something is wrong with the medical device 10 and may be used to trigger an alarm function to alert the patient or physician.

[0287] Parameters related to the power consumption of the medical equipment system to avoid excessive power consumption that may deplete and / or damage the energy storage unit 40. Excessive power consumption may be an indicator that something is wrong with the medical device 10 and may be used to trigger an alarm function to alert the patient or physician.

[0288] Parameters related to strain on a medical device, such as strain on the esophagus associated with a device that contracts the esophagus. Measuring strain can help avoid excessive strain that could damage the medical device or the patient's tissue. Excessive strain can also be an indicator of a malfunction in the medical device 10 and can be used to activate an alarm function to alert the patient or physician.

[0289] Parameters related to wireless transmission of energy from an energy source external to the patient's body: excessive wireless energy transmission can damage implanted wireless energy receiving devices and energy storage units, and can also cause excessive heating that can damage patient tissue.

[0290] The controller 300 may include sensors or may be configured to receive sensor inputs from sensors configured to sense physiological parameters of the patient, such as:

[0291] A parameter related to a patient's swallowing, to enable control of a medical device based on the patient's eating and drinking. The sensor configured to sense the parameter related to the patient's swallowing may comprise a piezoelectric or piezoresistive motility sensor, or an acceleration sensor. Alternatively, an acoustic sensor, such as a microphone, may be used to sense the patient's swallowing by picking up sounds made by the patient's swallowing. Alternatively, an optical sensor may be used to sense changes in opacity on the esophagus as food passes through. A strain sensor may be used to sense the distension of the esophagus as food passes through.

[0292] Localized temperature to avoid localized excessive heating that could damage the patient's tissue.

[0293] Whole body temperature to avoid excessive systemic heating that may cause fever and affect the patient's overall health.

[0294] Parameters related to blood saturation / oxygenation or ischemic markers such as lactate, to control and / or avoid obstruction of blood flow to a tissue area due to implantation or manipulation of the medical device 10. Impeded blood flow can lead to tissue damage and, in extreme cases, tissue necrosis.

[0295] Blood pressure, which may indicate that the strain caused by the medical device is taking a toll on the patient's overall health. Increased blood pressure can be used to activate an alarm function to alert the patient or physician.

[0296] pH. This measures stomach acidity, which can be an indicator of digestive system function and / or frequency of eating. pH can be used to control the medical device 10 based on what the patient eats and drinks.

[0297] The controller 300 may further include a receiver for receiving a patient-generated control signal from a unit located outside the patient's body. The receiver may be a wireless receiver configured to communicate with a transmitter located outside the patient's body. The controller 300 may be configured to control the device 100 based on the received patient-generated control signal. The control signal may, for example, indicate that the patient has finished eating a portion of food, causing the medical device 100 to operate to contract the esophagus and / or cardia. Alternatively, the controller 300 may be configured to control the device 100 based on a signal related to elapsed time or time of day, so as to provide contractions at regular intervals or during specific periods of the day. The controller 300 may further be configured to receive signals from a sensor located outside the patient's body and use such signals to control the operation of the medical device 10. The sensor located outside the patient's body may be a sensor measuring a parameter related to the patient's meal to generate input for the control of the medical device 10. Such parameters may relate to body temperature, blood pressure, or blood glucose levels. Alternatively, the sensor may be a sensor that senses a parameter related to the external environment, such as atmospheric pressure, which may affect the pressure within the medical device 10 .

[0298] FIG. 46 is a front view of a portion of a patient's abdomen when medical device 10 (previously referred to in the figures as device 100) has been implanted. However, this is merely an example embodiment, and it will be apparent that any of the medical device embodiments disclosed herein may be implanted and connected in the manner described with reference to FIG. 46 . The device, i.e., medical device 10, in the embodiment shown in FIG. 46 is operated by a remote unit 140. However, this is merely an example of a remote unit for operating medical device 10, and it will be apparent that any of the remote unit embodiments disclosed herein may be implanted and connected in the manner described with reference to FIG. 46 . Remote unit 140 comprises a first portion 141′, a second portion 141″, and a connecting portion 142 that mechanically connects the first and second portions 141′, 141″. In the embodiment shown in FIG. 46 , second portion 141″ is positioned inside the musculature MT of the patient's abdominal wall AW, while first portion 141′ is positioned outside the musculature MT of the abdominal wall AW, in the subcutaneous tissue ST. In this manner, the connecting portion 142 moves through a hole formed in the muscle of the muscle tissue MT or a natural opening between the muscles of the muscle tissue MT. The cross-sectional area of ​​the connecting portion 142 in a plane extending through the muscle tissue MT is smaller than the cross-sectional area of ​​the first and second portions 141′, 141″ parallel to the cross-sectional area of ​​the connecting portion 142. The cross-sectional areas of the first and second portions 141′, 141″ are also larger than the formed hole or natural opening in which the connecting portion 142 is disposed. Therefore, the first and second portions 141′, 141″ cannot pass through the formed hole or natural opening and are fixed to the muscle tissue MT of the abdominal wall. This allows the remote unit 140 to be suspended and fixed to the muscle tissue MT of the abdominal wall AW. The connecting portion 142 may have a circular cross-section and an axial direction AD extending from the first portion 141′ to the second portion 141″. In the embodiment of FIG. 46, the plane of extension of the muscle tissue MT is perpendicular to the axial direction AD of the connecting portion 142 extending from the first portion 141' to the second portion 141''.

[0299] The controller is disposed in the second portion 141" and the implantable energy storage unit is disposed in the first portion 141'. The controller and the implantable energy storage unit are electrically connected to each other by leads running within the connecting portion 142 so that electrical energy and communications may be transferred from the second portion 141" to the first portion 141' and vice versa. In the embodiment of FIG. 46, the first portion 141' further comprises a wireless energy receiver for receiving wireless energy for charging the implantable energy storage unit and / or powering the medical device 10, and a transceiver for receiving and / or transmitting wireless signals to and from outside the body. Additional features and functions of the controller and the implantable energy storage unit are further described with reference to FIGS. 65A-65e and 66A-66h. See FIGS. 65A-65e and 66A-66h.

[0300] The abdominal wall (AW) is generally composed of layers of skin, fat / fascia, muscle, and peritoneum. The deepest layer of the abdominal wall (AW) is the peritoneum (PT), which covers many abdominal organs, including the large and small intestines. The peritoneum (PT) is a serous membrane consisting of a layer of mesothelium supported by a thin layer of connective tissue, providing a pathway for blood, lymphatic, and nerves to abdominal organs. The area of ​​the abdomen surrounded by the peritoneum (PT) is called the intraperitoneal cavity. Tissues and organs within the abdominal cavity are called "intraperitoneal" (e.g., stomach and intestines). Intraperitoneal tissues and organs located posterior to the intraperitoneal cavity are called "retroperitoneal" (e.g., kidneys), while tissues and organs located inferior to the intraperitoneal cavity are called "subperitoneal" or "infraperitoneal" (e.g., bladder).

[0301] The peritoneum (PT) is connected to a layer of extraperitoneal fat (EF), which is connected to the transversalis fascia (TF). Connected to the transversalis fascia (TF) in sections of the abdominal wall (AW) is muscle tissue (MT), separated by a layer of deep fascia (DF). The deep fascia (DF) between the muscles is thinner than Scarpa's fascia (SF), which is located outside the transversalis fascia (TF) and muscle tissue (MT). Both the transversalis fascia (TF) and Scarpa's fascia (SF) are relatively stiff, membranous sheets. In sections of the abdominal wall (AW), the muscle tissue (MT) is composed of the transversus abdominis (TM), internal oblique (IM), and external oblique (EM). In other areas of the abdominal wall (AW), the muscle tissue may also be composed of the rectus abdominis and pyramidal muscles.

[0302] The layer outside the muscle tissue (MT) and beneath the patient's skin (SK) is called the subcutaneous tissue (ST), also known as the subcutaneous tissue, subcutaneous dermis, subcutaneous fascia, or superficial fascia. The main part of the subcutaneous tissue (ST) is made up of Camper's fascia, which is primarily loose connective tissue and fat. Typically, the subcutaneous tissue (ST) contains larger blood vessels and nerves than those found in the skin.

[0303] Positioning the remote unit 140 in the abdominal region is advantageous because the remote unit 140 does not significantly impact the patient sensory or visually, and the intestines are easily displaced to create sufficient space for the remote unit 140. Positioning the remote unit 140 in the abdominal region also allows the remote unit 140 to be secured to abdominal musculature MT to create a secure attachment for the remote unit 140. In the embodiment shown in FIG. 46, a first portion 141′ of the remote unit 140 is positioned on the patient's left side between the peritoneum PT and the musculature MT. The first portion 141′ is positioned in the subcutaneous tissue ST between the musculature MT and the patient's skin SK. The subcutaneous placement of the first portion 141' allows for easy access to the first portion 141', for example, for wireless communication using a wireless transceiver located in the first portion 141', wireless charging of an implantable storage device using a wireless energy receiver located in the first portion 141', manual operation of, for example, a push button located in the first portion 141', or maintenance or replacement of the first portion 141' through a small incision in the skin SK of the first portion 141'.

[0304] 46, electrical leads 135 running inside a protective cover 136 transmit electrical signals from the remote unit 140 to the main portion M of the medical device 10. The leads 135 run vertically between the peritoneum PT and the muscle tissue MT until the leads 135 reach the level of the main portion M of the medical device 10. At this level, the leads 135 enter the peritoneum PT and travel substantially horizontally to the main portion M of the medical device 10. In this manner, the leads 135 are positioned as short a distance as possible within the abdominal cavity, thereby reducing the risk of implanted foreign objects disturbing intraperitoneal organs, reducing the risk of organ damage, and reducing the risk of the foreign objects causing an ileus.

[0305] In the embodiment shown in FIG. 46 , connecting portion 142 connects first and second portions 141′, 141″ through three layers of muscle tissue MT: the tissue of the transversus abdominis TM, the internal oblique IM, and the external oblique EM. However, in alternative embodiments, it is contemplated that second portion 141″ may be positioned between muscle layers, such as between the tissue of the transversus abdominis TM, the internal oblique IM, or the internal and external oblique EM. Thus, in alternative embodiments, it is contemplated that connecting portion 142 connects first and second portions 141′, 141″ through two layers of muscle tissue MT or through one layer of muscle tissue MT.

[0306] In alternative embodiments, it is further contemplated that first portion 141' may be positioned between muscle layers, such as between the tissue of the external oblique muscle EM and the internal oblique muscle IM, or between the tissue of the internal oblique muscle IM and the transversus abdominis muscle TM.

[0307] 47A, 47B, and 48 illustrate an embodiment of a remote unit 140. The remote unit 140 is configured to be held in place by a tissue portion 610 of a patient. The remote unit 140 includes a first portion 141′ configured to be disposed on a first side 612 of the tissue portion 610, the first portion 141′ having a first cross-sectional area A1 in a first plane P1 and including a first surface 614 configured to face a first tissue surface 616 of the first side 612 of the tissue portion 610. The remote unit 140 further includes a second portion 141″ configured to be disposed on a second side 618 of the tissue portion 610, the second side 618 facing the first side 612, the second portion 141″ having a second cross-sectional area A2 in a second plane P2 and including a second surface 620 configured to engage a second tissue surface 622 of the second side 618 of the tissue portion 610. The remote unit 140 further includes a connecting portion 142 configured to be positioned through a hole in the tissue portion 610 extending between the first and second side surfaces 612, 618 of the tissue portion 610. The connecting portion 142 here has a third cross-sectional area A3 in a third plane P3, a fourth cross-sectional area A4 in a fourth plane P4, and a third surface 624 configured to engage the first tissue surface 616 of the first side surface 612 of the tissue portion 610. The connecting portion 142 is configured to connect the first portion 141′ to the second portion 141″.

[0308] Thus, connecting portion 142 has a portion sized and shaped to fit through the hole in tissue portion 610, with such portion having a third cross-sectional area A3. Additionally, connecting portion 142 may have another portion sized and shaped not to fit through the hole in tissue portion 610, with such portion having a fourth cross-sectional area A4. Similarly, second portion 141'' may have a portion sized and shaped not to fit through the hole in tissue portion 610, with such portion having a second cross-sectional area A2. Thus, connecting portion 142 can cooperate with second portion 141'' to hold the device in place in the hole in tissue portion 610.

[0309] 47A, first portion 141' is configured to detachably, i.e., reversibly, connect to connecting portion 142 by a mechanical and / or magnetic mechanism. In the illustrated embodiment, a mechanical mechanism is used in which one or more spring-loaded spherical elements 601 are locked into position in grooves 603 in connecting portion 142 when first portion 141' is inserted into connecting portion 142. Other locking mechanisms are also envisioned, such as corresponding threads or grooves, self-locking elements, twist-lock joints, etc.

[0310] Remote unit 140 is configured, when implanted, such that first portion 141′ is positioned closer to the exterior of the patient than second portion 141″. Furthermore, in some implantation procedures, remote unit 140 may be implanted such that space is available beyond the second portion, i.e., beyond second side 618 of tissue portion 610, while an equal amount of space may exist on first side 612 of the tissue portion. Furthermore, tissue and / or skin may exert a force on second portion 141″ toward tissue portion 610, preventing second portion 141″ from migrating through holes in the tissue portion toward first side 612 of the tissue portion. Thus, it is preferred if remote unit 140 is primarily configured to prevent first portion 141′ from migrating through holes in tissue portion 612 toward second side 618 of tissue portion 610.

[0311] The first portion 141′ may further include one or more connectors 605 for transmitting energy and / or communication signals to the second portion 141″ via the connecting portion 142. The connectors 605 in the illustrated embodiment are symmetrically arranged around the circumference of the protrusion 607 of the first portion 141′ and are positioned to engage with corresponding connectors 609 positioned on the inner surface of the connecting portion 142. The protrusion 607 may extend to a central extension C1 of the central portion 142. The second portion 141″ may also include one or several connectors 611, which may be positioned and configured similarly to the connectors 605 of the first portion 141′. For example, the one or several connectors 611 may engage with the connectors 609 of the connecting portion 142 to receive energy and / or communication signals from the first portion 141′. Although the protrusion 607 is illustrated separately in Figures 47A and 47B, it should be understood that the protrusion 607 may be integrally formed with the first portion 141'.

[0312] Other arrangements of the connectors are also contemplated, such as connectors arranged asymmetrically around the circumference of the protrusion 607. It is also contemplated that one or several connectors may be arranged on the first surface 614 of the first portion 141′, arranged to engage with corresponding connectors arranged on the opposing surface 613 of the connector. Such connectors on the opposing surface 613 may cover a relatively larger area compared to the connector 609, thus enabling a larger contact area and a higher speed and / or signal strength of the transmission of energy and / or communication signals. Furthermore, it is contemplated that the physical connection between the first portion 141′, the connecting portion 142, and the second portion 141″ may be replaced by or involve a wireless arrangement, as further described elsewhere in this disclosure.

[0313] Any of the first surface 614 of the first portion 141′, the second surface 620 of the second portion 141′, the third surface 624 of the connecting portion 142, and the opposing surface 613 of the connecting portion 142 may include at least one of ribs, barbs, hooks, friction-enhancing surface treatments, and friction-enhancing materials to facilitate holding the remote unit 140 in place by the tissue portion and / or to facilitate holding different portions of the device in place relative to each other.

[0314] The opposing surface 613 of connecting portion 142 and the first surface 614 of first portion 141′ can provide, in whole or in part, a connection mechanism for removably connecting first portion 141′ to connecting portion 142. Such connection mechanisms have been described earlier in this disclosure, can be located on one or both of opposing surface 613 and first surface 614, and will not be described further here.

[0315] The facing surface 613 may comprise a recess configured to accommodate at least a portion of the first portion 141′. In particular, such recess may be configured to receive at least a portion of the first portion 141′, including the first surface 614. Similarly, the first surface 614 may comprise a recess configured to accommodate at least a portion of the connecting portion 142. In particular, such recess may be configured to receive at least a portion of the connecting portion 142, and in some embodiments, such recess may be configured to receive at least one protruding element to at least partially surround at least one protruding element or flange.

[0316] In the illustrated embodiment, the first portion 141′ comprises a first energy storage unit 304a and a controller 300a consisting of one or more processing units connected to the first energy storage unit 304a. The first energy storage unit 304a may be rechargeable via wireless energy transfer. In some embodiments, the first energy storage unit 304a may be non-rechargeable. Upon expiration of such a first energy storage life, a replacement first portion including a new first energy storage unit may simply be swapped in place of the first portion having the worn-out first energy storage unit. The second portion 141″ may further comprise a controller 300b consisting of one or more processing units.

[0317] As described elsewhere in this disclosure, the first portion 141′ and the second portion 141″ may be comprised of one or more functional portions such as a receiver, a transmitter, a transceiver, a control unit, a processing unit, a sensor, an energy storage unit, a sensor, etc.

[0318] The remote unit 140 may be non-inflatable.

[0319] The first portion 141' may be removably coupled to at least one of the coupling portion 142 and the second portion 141''.

[0320] 48 , the first, second, third, and fourth planes P1, P2, P3, and P4 are parallel to one another. Furthermore, in the illustrated embodiment, the third cross-sectional area A3 is smaller than the first cross-sectional area A1, the second cross-sectional area A2, and the fourth cross-sectional area A4, such that the first portion 141′, the second portion 141″, and the connecting portion 142 are prevented from moving through the holes in the tissue portion 610 in a direction perpendicular to the first plane P1, the second plane P2, and the third plane P3. This allows the second portion 141″ and the connecting portion 142 to be held in place by the patient's tissue portion 610 even when the first portion 141′ is separated from the connecting portion 142.

[0321] It should be understood that the illustrated planes P1, P2, P3, and P4 are merely examples of how such planes may intersect with remote unit 140. Other arrangements of planes are possible as long as the above conditions are met, i.e., the portion has a cross-sectional area, the third cross-sectional area in third plane P3 is smaller than the first, second, and fourth cross-sectional areas, and the planes P1, P2, P3, and P4 are parallel to one another.

[0322] 47A can be defined as a connecting portion 142 comprising a flange 626. The flange 626 thus defines a fourth cross-sectional area A4 that is prevented from moving through the hole in the tissue portion 610 in a direction perpendicular to the first, second, and third planes P1, P2, and P3. The flange 626 may protrude in a direction parallel to the first, second, third, and fourth planes P1, P2, P3, and P4. This direction is perpendicular to the central extension C1 of the connecting portion 142.

[0323] However, the connecting portion 142 is not limited to a flange. Other protruding elements may additionally or alternatively be incorporated into the connecting portion 142. Thus, the connecting portion 142 may include at least one protruding element defining a fourth cross-sectional area A4, and such at least one protruding element is prevented from moving through a hole in the tissue portion 610 so that the second portion 141″ and the connecting portion 142 can be held in place by the patient's tissue portion 610 even when the first portion 141′ is detached from the connecting portion 142. The at least one protruding element may protrude in a direction parallel to the first, second, third, and fourth planes P1, P2, P3, and P4. This direction is perpendicular to the central extension C1 of the connecting portion 142. Thus, the at least one protruding element also defines a third surface configured to engage the first tissue surface 616 of the first side 612 of the tissue portion 610.

[0324] The connecting portion 142 may include a hollow portion 628. The hollow portion 628 may provide a passageway between the first and second portions 141′, 141″. In particular, the hollow portion 628 may accommodate a conduit for transferring a fluid from the first portion 141′ to the second portion 141″. The hollow portion 628 may also define or accommodate one or several connections or electrical leads for transmitting energy and / or communication signals between the first portion 141′ and the second portion 141″.

[0325] 48 and 49A-49C, some relative dimensions of remote unit 140 will now be described, with the understanding that these dimensions may also apply to other embodiments of remote unit 140. At least one protruding element 626 may have a height HF in a direction perpendicular to the fourth plane that is less than a height H1 of first portion 141′ in that direction. Height HF may alternatively be less than half the height H1 of first portion 141′ in that direction, less than a quarter of the height H1 of first portion 141′ in that direction, or less than a tenth of the height H1 of first portion 141′ in that direction.

[0326] The height H1 of the first portion 141' in a direction perpendicular to the first plane may be smaller than the height H2 of the second portion 141'' in said direction, for example, less than half the height H2 of the second portion 141'' in said direction, less than a quarter of the height H2 of the second portion 141'' in said direction, or less than a tenth of the height H2 of the second portion 141'' in said direction.

[0327] At least one protruding element 626 may have a diameter DF in the fourth plane that is one of: smaller than diameter D1 of first portion 141′ in the first plane, equal to diameter D1 of first portion 141′ in the first plane, and larger than diameter D1 of first portion 141′ in the first plane. Similarly, the cross-sectional area of ​​at least one protruding element 626 in the fourth plane may be smaller than, equal to, or larger than the cross-sectional area of ​​the first portion in the first plane.

[0328] At least one protruding element 626 may have a height HF in a direction perpendicular to the fourth plane that is smaller than a height HC of the connecting portion 142 in said direction, where the height HC of the connecting portion 142 is defined as the height excluding the at least one protruding element that forms part of the connecting portion 142. The height HF may alternatively be less than half the height HC of the connecting portion 142 in said direction, less than one-quarter the height HC of the connecting portion 142 in said direction, or less than one-tenth the height HC of the connecting portion 142 in said direction.

[0329] As shown in FIGS. 50A-50B, the at least one protruding element 626 can have an annular shape, such as a disk shape. However, elliptical, elongated, and / or other polyhedral or irregular shapes are also possible. In the illustrated embodiment, the at least one protruding element 626 extends one revolution around the central axis of the connecting portion 142. However, other arrangements are possible in which the at least one protruding element 626 forms a partial circular sector. In the case of multiple protruding elements, such multiple protruding elements may form multiple partial circular sectors.

[0330] 51A-51B and 52A-52B, the connecting portion 142 may be comprised of at least two protruding elements 626, 627. For example, the connecting portion 142 may be comprised of at least three, four, five, seven, eight, nine, or ten protruding elements. In such embodiments, the at least two protruding elements 626, 627 may together define a fourth cross-sectional area, thus providing the cross-sectional area necessary to prevent the first and second portions from migrating through a hole in the tissue portion.

[0331] The at least two protruding elements 626, 627 may be symmetrically positioned about the central axis of the connecting portion, as shown in Figures 51A-51B, or asymmetrically positioned about the central axis of the connecting portion, as shown in Figures 52A-52B. In particular, the at least two protruding elements 626, 627 may be asymmetrically positioned toward one side of the connecting portion 142, as shown in Figures 52A-52B. The positioning of the protruding elements allows the remote unit 140, and in particular the connecting portion 142, to be positioned in an area of ​​the patient where space is limited in one or more directions.

[0332] The first portion 141 ′ may constitute a first energy storage unit for supplying energy to the remote unit 140 .

[0333] While one type or embodiment of implantable remote unit 140 may fit most patients, it may be necessary to provide a selection of implantable remote units 140 or parts that assemble into implantable remote units 140. For example, some patients may require different lengths, shapes, sizes, widths, or heights depending on their individual anatomy. Furthermore, some parts or parts of implantable remote unit 140 may be common among several different types or embodiments of remote units, while other parts or parts may be interchangeable or replaceable. Such parts or parts may include energy storage devices, communication devices, fluid connections, mechanical connections, electrical connections, etc.

[0334] To provide flexibility and ease of use, a kit of parts may be provided. The kit preferably comprises one or more groups of first parts, one or more groups of second parts, and one or more groups of connecting parts, the first parts, second parts, and connecting parts being embodied as described throughout this disclosure. At least one of the groups comprises at least two different types of said respective parts. By the term "type" herein is meant a variety, class, or embodiment of said respective parts.

[0335] In some embodiments of the kit, the one or more groups of first portions, the one or more groups of second portions, and the one or more groups of connecting portions constitute separate components that can be assembled into a complete remote unit. Thus, the remote unit can be said to be modular in that the first portions, second portions, and / or connecting portions are interchangeable with other types of respective portions.

[0336] In some embodiments, the linking moiety forms part of the first portion or the second portion.

[0337] 53, a kit for assembling a remote unit comprises one or more groups 650 of first portions 141′, in the illustrated example one group of first portions 141′, one or more groups 652 of connecting portions 142, in the illustrated example three groups of connecting portions 142, and one or more groups 654 of second portions 141″, in the illustrated example two groups of second portions 141″. For simplicity, not all types and combinations of first portions, second portions and connecting portions are shown or described in detail.

[0338] Thus, a group 652 of one or more connecting portions 142 is made up of three different types of connecting portions 142. Here, the different types of connecting portions 142 are made up of connecting portions 142a, 142b, and 142c having different heights. Furthermore, a group 654 of one or more second portions 141'' is made up of two different types of second portions 141''.

[0339] Here, a different type of second portion 141'' is shown, comprising a second portion 141''a having a first end and a second end, configured for eccentric connection to a connection portion as described elsewhere in this disclosure, the second end of second portion 141''a comprising or configured for connection to an implant located caudally from the location of the remote unit within the patient when the device is assembled. In the illustrated illustration, the at least one connection is visualized as a lead or wire. However, other embodiments are possible, including those in which the second end is comprised of a port, connector, or other type of connection element for power, fluid, and / or signal transmission.

[0340] Additionally, a different type of second portion 141'' may include a second portion 141''b configured for eccentric connection to a connection portion, as described elsewhere in this disclosure, having a first end and a second end, the first end of second portion 141''b comprising or configured for connection to an implantable medical device for treating reflux disease in a patient, the implantable medical device being located cephalad from the location of the remote unit within the patient when the device is assembled. In the illustrated illustration, the at least one connection is visualized as a lead or wire. However, other embodiments are possible, including where the first end is comprised of a port, connector, or other type of connection element for power, fluid, and / or signal transmission.

[0341] In this way, the remote device may be modular, and different types of devices may be realized by selecting and combining first portion 141′, connecting portion 142, and second portion 141″ from each of groups 652, 654, 656.

[0342] In the illustrated embodiment, a first remote unit 140a is realized by selecting a first portion 141′, a connecting portion 142a, and a second portion 141″a. Such a remote unit 140a may be particularly advantageous in that connecting portion 142a may extend through thick layers of tissue to connect first portion 141′ and second portion 141″a. Another remote unit 140b is realized by selecting a first portion 141′, a connecting portion 142c, and a second portion 141″b. Such a device is particularly advantageous in that connecting portion 142c has a smaller footprint, i.e., occupies less space within the patient, than connecting portion 142a. The modular nature of remote units 140a and 140b allows a practitioner or surgeon to evaluate a patient's anatomy and then select the appropriate connecting portion as needed. Furthermore, because remote units 140a and 140b share a common type of first portion 141', it is not necessary for the practitioner or surgeon to maintain an inventory of different first portions (or an inventory of complete assembled devices) simply to achieve a device having different connections located at the first or second ends of the second portions, as is the case with second portions 141''a, 141''b, respectively.

[0343] The embodiment shown in FIG. 53 is merely illustrative to illustrate the idea of ​​a modular implantable remote unit 140. The group 650 of one or more first portions 141′ may include a variety of different features, such as first portions with or without a first energy storage unit, first portions with or without a first wireless energy receiving unit for receiving energy wirelessly transmitted by an external wireless energy transmitter, first portions with or without an internal wireless energy transmitter, and / or other features as described throughout this disclosure. Other features include different heights, widths, or lengths of the first portions. It should be understood that first portions having one or more of these features can be combined with specific shapes or dimensions to achieve various first portions. The same applies to the connecting portion and second portion.

[0344] Referring to FIG. 54 , one embodiment of an implantable remote unit 140 is described. The remote unit 140 is configured to be held in place by a tissue portion 610 of a patient. The remote unit 140 comprises a first portion 141′ configured to be disposed on a first side of the tissue portion 610, the first portion 141′ having a first cross-sectional area in a first plane and comprising a first surface configured to face and / or engage a first tissue surface on the first side of the tissue portion 610. The device 140 further comprises a second portion 141″ configured to be disposed on a second side of the tissue portion 610, the second side facing the first side, the second portion 141″ having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface on the second side of the tissue portion 610. The remote unit 140 further comprises a connecting portion 142 configured to be disposed through a hole in the tissue portion 610 extending between the first and second sides of the tissue portion 610. Here, the connecting portion 142 has a third cross-sectional area in a third plane. The connecting portion 142 is configured to connect the first portion 141′ to the second portion 141″. Here, the first portion 141′ comprises a first wireless energy receiver 308a for receiving energy wirelessly transmitted by an external wireless energy transmitter, and an internal wireless energy transmitter 308a configured to wirelessly transmit energy to the second portion. Further, here, the second portion comprises a second wireless energy receiver 308b configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter 308a.

[0345] While the receiver and transmitter are sometimes discussed and illustrated separately in this disclosure, it should be understood that the receiver and / or transmitter may be configured within a transceiver. Furthermore, the receiver and / or transmitter of each of the first and second portions 141′ and 141″ may form part of a single receiving or transmitting unit configured to receive or transmit energy signals and / or communication signals including data. Furthermore, the internal wireless energy transmitter and / or first wireless communication receiver / transmitter may be a separate unit 308c located in a lower portion of the first portion 141′, near the connecting portion 142 and the second portion 141″, referred to elsewhere in this disclosure as the proximal end of the first portion 141′. Such an arrangement may provide that the energy and / or communication signals transmitted by unit 308c are not attenuated by internal components of the first portion 141′ when transmitted to the second portion 141″. Such internal components may include the first energy storage unit 304a.

[0346] Here, the first part 141' consists of a first energy storage unit 304a connected to a first wireless energy receiver 308a. The second part consists of a second energy storage unit 304b connected to a second wireless energy receiver 308b. Such energy storage units may be solid-state batteries, such as thionyl chloride batteries.

[0347] In some embodiments, the first wireless energy receiver 308a is configured to receive energy wirelessly transmitted by an external wireless energy transmitter and store the received energy in the first energy storage unit 304a. Further, the internal wireless energy transmitter 308a is configured to wirelessly transmit the energy stored in the first energy storage unit 304a to the second wireless energy receiver 308b, and the second wireless energy receiver 308b is configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter 308a and store the received energy in the second energy storage unit 305b.

[0348] The first energy storage unit 304a may be configured to store less energy than the second energy storage unit 304b and / or may be configured to charge faster than the second energy storage unit 304b. This allows the first energy storage unit 304a to charge relatively quickly, while energy transfer from the first energy storage unit 304a to the second energy storage unit 304b occurs relatively slowly. Thus, a user can quickly charge the first energy storage unit 304a without being restricted for a long period of time during such charging, for example, by being connected to an external wireless energy transmitter in a particular location. After charging the first energy storage unit 304a, the user can move freely while energy is slowly transferred from the first energy storage unit 304a to the second energy storage unit 304b via the first wireless energy transmitters 308a,c and the second wireless energy receiver 308b.

[0349] The first part may comprise a first controller including at least one processing unit 306 a. The second part may comprise a second controller including at least one processing unit 306 b. At least one of the first and second processing units 306 a, 306 b may be connected to a wireless transceiver 308 a, b, c for wireless communication with external devices.

[0350] The first controller may be connected to the first wireless communication receiver 308a,c in the first portion 141′ to receive wireless communications from an external device and / or from the wireless communication transmitter 308b in the second portion 141″. Further, the first controller may be connected to the first wireless communication transmitter 308a,c in the first portion 141′ to transmit wireless communications to the second wireless communication receiver 308b in the second portion 141″. The second controller may be connected to the second wireless communication receiver 308b to receive wireless communications from the first portion 141′. The second controller may further be connected to the second wireless communication transmitter 308b to transmit wireless communications to the first portion 141′.

[0351] In some embodiments, as shown in FIG. 64, the first wireless energy receiver 308a comprises a first coil and the wireless energy transmitter 308a,c comprises a second coil.

[0352] The apparatus may further include at least one sensor (not shown) for providing input to at least one of the first and second controllers. Such sensor data may be transmitted to an external device via the first wireless communication transmitter 308a and / or the second wireless communication transmitter 308b. The sensor may be or consist of a sensor configured to sense a physical parameter of the device 140. The sensor may also be or consist of a sensor configured to sense at least one of the following: a temperature of the remote unit 140; a temperature of an implantable device (which may be located in the main portion) for stretching the stomach wall; a parameter related to the power consumption of the device; a parameter related to the power consumption of a stimulator for stimulating muscle tissue contacted by the implantable device; a parameter related to the status of at least one of the first and second energy storage units 304a, 304b; and a parameter related to the wireless transfer of energy from a source external to the patient's body. The sensor may also be or consist of a sensor configured to sense a patient's physiological parameters, such as at least one of a parameter related to the patient's swallowing, local temperature, systemic temperature, blood saturation, blood oxygenation, blood pressure, a parameter related to an ischemic marker, or pH. The sensor configured to sense a parameter related to the patient's swallowing may consist of at least one of a motility sensor, an acoustic sensor, an optical sensor, and a strain sensor. The sensor configured to sense pH may be configured to sense acidity in the stomach.

[0353] The sensors may be configured to sense the temperature of the device 140 to avoid excessive heating of tissue connected to the device during operation of the device, or during operation of an external implant using the device, or during charging of an energy storage unit within the device 140. Excessive heating may also damage the device and / or the energy storage unit. Excessive heating may also be an indicator of a malfunction in the device and may be used to trigger an alarm function to alert the patient or physician. The sensors may also be configured to sense parameters related to the power consumption of the device 140 or the power consumption of an external implant powered by the device 140 to avoid excessive power consumption that may deplete and / or damage the energy storage unit of the device 140. Excessive power consumption may also be an indicator of a malfunction in the device 140 and may be used to trigger an alarm function to alert the patient or physician.

[0354] 55, 58A, and 58B, an embodiment of an implantable remote unit 140 is described. The remote unit 140 is configured to be held in place by a tissue portion 610 of a patient. The remote unit 140 includes a first portion 141′ configured to be disposed on a first side 612 of the tissue portion 610, the first portion 141′ having a first cross-sectional area A1 in a first plane P1 and including a first surface 614 configured to face and / or engage a first tissue surface 616 of the first side 612 of the tissue portion 610. The remote unit 140 further comprises a second portion 141″ configured to be disposed on a second side 618 of the tissue portion 610, the second side 618 facing the first side 612, the second portion 141″ having a second cross-sectional area A2 in a second plane P2 and a second surface 620 configured to engage a second tissue surface 622 of the second side 618 of the tissue portion 610. The remote unit 140 further comprises a connecting portion 142 configured to be disposed through a hole in the tissue portion 610 extending between the first and second sides 612, 618 of the tissue portion 610, the connecting portion 142 here having a third cross-sectional area A3 in a third plane P3. The connecting portion 142 is configured to connect the first portion 141′ to the second portion 141″. In the illustrated embodiment, the coupling interface 630 between the coupling portion 142 and the second portion 141'' is eccentric relative to the second portion 141''.

[0355] First portion 141' has an elongated shape in the illustrated embodiment of FIG. 55. Similarly, second portion 141'' has an elongated shape. However, first portion 141' and / or second portion 141'' may have other shapes, such as, for example, a flat disk having a width and length greater than its height, a sphere, an ellipsoid, or any other polyhedral or irregular shape, some of which are illustrated in FIGS. 55-57.

[0356] As shown in FIGS. 58A and 58B , the connection interface 630 between the connecting portion 142 and the second portion 141″ may be eccentric relative to the second portion 141″ in a first direction 631, but may not be eccentric in a second direction 633 perpendicular to the first direction. The first direction 631 here is parallel to the line AA, the second plane P2, and the length of the second portion 141″. The second direction 633 here is parallel to the line BB, parallel to the second plane P2, and parallel to the width of the second portion 141″. It is also possible for the connection interface between the connecting portion 142 and the second portion 141″ to be eccentric relative to the second portion 141″ not only in the first direction 631, but also in the second direction 633 perpendicular to the first direction 631.

[0357] Similarly, the connection interface between the connecting portion 142 and the first portion 141' may be off-center in the first direction 631 and / or the second direction 633 relative to the first portion 141'.

[0358] The first portion 141′, the connecting portion 142, and the second portion 141″ may form a structurally integral unit. However, it is also possible that the first portion 141′ and the connecting portion 142 form a structurally integral unit while the second portion 141″ forms a separate unit, or that the second portion 141″ and the connecting portion 142 form a structurally integral unit while the first portion 141′ forms a separate unit.

[0359] Additionally or alternatively, second portion 141'' may include a removable and / or replaceable portion 639. In some embodiments, removable portion 639 may form part of a distal region, as further described elsewhere in this disclosure. The removable portion may also form part of a proximal region. Thus, second portion 141'' may include at least two removable portions, each disposed at a respective end of second portion 141''. Removable portion 639 may house, hold, or form one or several functional components of remote unit 140, such as gears, motors, connections, reservoirs, etc., as described elsewhere in this disclosure. Embodiments having such removable portions 639 may be modified as needed depending on the specific patient situation.

[0360] When first portion 141′, connecting portion 142, and second portion 141″ structurally form one integral unit, the eccentric connecting interface between connecting portion 142 and second portion 141″ allows remote unit 140 to be inserted into a hole in a tissue portion relative to second portion 141″. Remote unit 140 can be inserted at an angle into the hole, similar to how a foot is inserted into a shoe, for example, to allow most or all of second portion 141″ to pass through the hole, before being angled, rotated, and / or pivoted to allow the remainder of second portion 141″ to pass through the hole, thereby allowing remote unit 140 to be in its intended position.

[0361] As shown in Figures 55-57, the first portion 141' can assume various shapes, such as an oval, a flattened disk, a sphere, or any other polyhedral or irregular shape. Similarly, the second portion 141'' can assume various shapes, such as an oval, a flattened disk, a sphere, or any other polyhedral or irregular shape. The proposed shapes of the first and second portions 141', 141'' may be mixed and matched to form embodiments not illustrated in the illustrated embodiment. For example, one or both of the first and second portions 141', 141'' may have a flattened oval shape. In this context, the term "flat" refers to the height of the first or second portion 141', 141''—i.e., the height in a direction parallel to the central extension C1 of the connecting portion 142. The term "oval" refers to the length of the first or second portion 141', 141''. The definition of such length is further discussed elsewhere in this disclosure.

[0362] 58A and 58B, the second portion 141'' has a first end 632 and a second end 634 opposite the first end 632. The length of the second portion 141'' is defined as the length between the first end 632 and the second end 634. The length of the second portion 141'' further extends in a different direction from the central extension C1 of the connecting portion 142. The first end 632 and the second end 634 are spaced apart in a direction parallel to the second plane P2. Similarly, the first portion 141' has a length between the first end and the second end, and the length extends in a different direction from the central extension C1 of the connecting portion 142.

[0363] Second portion 141'' may be curved along its length. For example, one or both ends of second portion 141'' may face in a direction substantially different from second plane P2, i.e., curved away from or toward the tissue portion when implanted. In some embodiments, second portion 141'' curves exclusively within second plane P2 or in combination with curvatures in other planes. Second portion 141'' may also be curved in multiple directions, i.e., along its length and along its width, the width extending perpendicular to the length.

[0364] The first and second ends 632, 634 of the second portion 141'' may each define a point on an ellipse. For example, the first and second ends 632, 634 may each define a hemispherical end cap. It should be understood that the first and second ends of the first portion 141' may also have such features.

[0365] The second portion 141'' can have at least one circular cross-section along its length between the first end 632 and the second end 634, as shown in FIG. 55. However, it is also possible for the second portion 141'' to have at least one elliptical cross-section or at least one elliptical cross-section along its length between the first end 632 and the second end 634. Such cross-sectional shapes can also be present between the ends in the width direction of the second portion 141''. Similarly, such cross-sectional shapes can also be present between the ends in the length direction and / or width direction of the first portion 141'.

[0366] In the following paragraphs, some features and characteristics of the second portion 141'' are described. However, it should be understood that these features and characteristics may also be applied to the first portion 141'.

[0367] The second portion 141'' has a proximal region 636, an intermediate region 638, and a distal region 640. The proximal region 636 extends from the first end 632 to the interface between the connecting portion 142 and the second portion 141'', the intermediate region 638 is defined by the connecting interface 630 between the connecting portion 142 and the second portion 141'', and the distal region 640 extends from the connecting interface 630 between the connecting portion 142 and the second portion 141'' to the second end 634. The proximal region 636 is shorter than the distal region 640 with respect to the length of the second portion, i.e., with respect to the longitudinal direction 631. Thus, the second portion 141'' has a heel (proximal region) and a toe (distal region).

[0368] The second surface 620 configured to engage the second tissue surface 622 of the second side 618 of the tissue portion 610 is part of the proximal region 636 and a part of the distal region 640. Defining the length of the second portion 141'' as x and the width of the second portion 141'' as y along the respective longitudinal and width directions 631, 633 that are perpendicular to each other and substantially parallel to the second plane P2, the connecting interface between the connecting portion 142 and the second portion 141'' is included in the region extending from x > 0 to x < x / 2 and / or from y > 0 to y < y / 2, where x and y and 0 are the respective end points of the second portion 141'' along the longitudinal and width directions. In other words, the connecting interface between the connecting portion 142 and the second portion 141'' is eccentric with respect to the second portion 141'' in at least one direction, such that a heel and a toe are formed on the second portion 141''.

[0369] The first surface 614 configured to face and / or engage the first tissue surface 616 of the first side 612 of the tissue portion 610 may be substantially flat. In other words, the first portion 141′ may include a substantially flat surface facing toward the tissue portion 610. Furthermore, the opposing surface of the first portion 141′ facing away from the tissue portion 610 may be substantially flat. Similarly, the second surface 620 configured to engage the second tissue surface 622 of the second side 618 of the tissue portion 610 may be substantially flat. In other words, the second portion 141″ may include a substantially flat surface facing toward the tissue portion 610. Furthermore, the opposing surface of the second portion 141″ facing away from the tissue portion 610 may be substantially flat.

[0370] The second portion 141'' may taper from the first end 632 toward the second end 634, thus giving the second portion 141'' a different height and / or width along the length of the second portion 141''. The second portion may also taper from each of the first end 632 and the second end 634 toward an intermediate region 638 of the second portion 141''.

[0371] Next, we disclose some dimensions of the first portion 141′, the second portion 141″, and the connecting portion 142. Any disclosure of numerical intervals below may or may not include the endpoints of the interval.

[0372] The first portion 141' may have a maximum dimension in the range of 10 to 60 mm, such as in the range of 10 to 30 mm, for example in the range of 10 to 40 mm, for example in the range of 10 to 25 mm, for example in the range of 15 to 40 mm, for example in the range of 15 to 35 mm, for example in the range of 15 to 30 mm, for example in the range of 15 to 25 mm. The term "maximum dimension" means the largest dimension in any direction.

[0373] The first portion 141' may have a diameter in the range of 10 to 60 mm, such as in the range of 10 to 30 mm, for example in the range of 10 to 40 mm, for example in the range of 10 to 25 mm, for example in the range of 15 to 40 mm, for example in the range of 15 to 35 mm, for example in the range of 15 to 30 mm, for example in the range of 15 to 25 mm.

[0374] The connecting portion 142 may have a maximum dimension in the third plane P3 in the range of 2 to 20 mm, for example, in the range of 2 to 15 mm, for example, in the range of 2 to 10 mm, for example, in the range of 5 to 10 mm, for example, in the range of 8 to 20 mm, for example, in the range of 8 to 15 mm, for example, in the range of 8 to 10 mm.

[0375] The second portion 141'' may have a maximum dimension in the range of 30 to 90 mm, such as in the range of 30 to 70 mm, for example in the range of 30 to 60 mm, for example in the range of 30 to 40 mm, for example in the range of 35 to 90 mm, for example in the range of 35 to 70 mm, for example in the range of 35 to 60 mm, for example in the range of 35 to 40 mm.

[0376] The first portion has a first height H1, and the second portion has a second height H2, both heights being perpendicular to the first and second planes P1 and P2. The first height may be less than the second height. However, in the embodiment shown in FIGS. 58A-58B, the first height H1 is substantially equal to the second height H2. Other height ratios are possible, for example, the first height H1 may be less than two-thirds of the second height H2, for example, less than one-half of the second height H2, for example, less than one-third of the second height H2, for example, less than one-quarter of the second height H2, for example, less than one-fifth of the second height H2, or for example, less than one-tenth of the second height H2.

[0377] As shown in FIGS. 58A-58B, proximal region 636 has a length 642 that is shorter than length 646 of distal region 640. Intermediate region 638 has a length 644 and a width 648. In some embodiments, length 644 of intermediate region 638 is longer than width 648. In other words, the connection interface between connecting portion 142 and second portion 141″ may be elongated, having a longer dimension (length, in the illustrative case) and a shorter dimension (width, in the illustrative case). It is also possible for length 644 of intermediate region 638 to be shorter than width 648 of intermediate region 638.

[0378] The length 646 of the distal region 640 is preferably longer than the length 644 of the intermediate region 638, but equally long distal region 640 and intermediate region 638, or a distal region 640 shorter than intermediate region 638, are also possible. The length 642 of the proximal region 636 may be shorter than, equal to, or longer than the length 644 of the intermediate region 638.

[0379] Length 644 of intermediate region 638 is preferably less than half the length of second portion 141″, i.e., less than half the combined length of proximal region 636, intermediate region 638, and distal region 630. In some embodiments, length 644 of intermediate region 638 is less than one-third the length of second portion 141″, e.g., less than one-quarter, one-fifth, or one-tenth the length of second portion 141″.

[0380] The connecting portion may have one of an elliptical cross-section, an elongated cross-section, and a circular cross-section in a plane parallel to the third plane P3. In particular, the connecting portion may have a plurality of different cross-sectional shapes along its length at the central extension C1.

[0381] 45C-45D show an embodiment similar to that described in conjunction with FIGS. 58A-58B. However, the embodiment of FIGS. 58C-58D lacks a proximal portion, i.e., second portion 141'' does not constitute a "heel." Furthermore, such an embodiment can have connecting portion 142 having a length and width, in directions 631 and 633, respectively, equal to the height of the second portion in a direction parallel to central extension C1, as shown. Thus, connecting portion 142 and second portion 141'' can be constituted by a body of substantially uniform width.

[0382] In some embodiments, the distal region 640 is configured to be oriented downward, i.e., toward the coccyx, in a standing patient when the remote unit 140 is implanted. As shown in FIGS. 59A-59D, different orientations of the second portion 141″ relative to the first portion 141′ are possible. In some embodiments, the connection between the first portion 141′ and the connecting portion 142 or the connection between the second portion 141″ and the connecting portion 142 may allow for multiple different connection orientations. For example, the connection mechanism between the first portion 141′ and the connecting portion 142 (or between the second portion 141″ and the connecting portion 142) may have 90-degree rotational symmetry to allow the second portion 141′ to be configured in four different positions relative to the first portion 141, each 90 degrees different from the others. Of course, other degrees of rotational symmetry are also possible, such as 30 degrees, 45 degrees, 60 degrees, 120 degrees, and 180 degrees. In other embodiments, there is no coupling mechanism between any of first portion 141′, connecting portion 142, and second portion 141″ (i.e., these portions are made as an integral unit), in which case different variations of device 140 can be realized during manufacturing. In other embodiments, the coupling mechanism between first portion 141′ and connecting portion 142 (or between second portion 141″ and connecting portion 142) is irreversible, i.e., first portion 141′ and second portion 141″ can be initially treated as separate parts, but the orientation of second portion 141″ relative to first portion 141′ cannot be changed once selected and the parts are coupled via connecting portion 142.

[0383] The different orientations of the second portion 141" relative to the first portion 141' can be defined as the relationship or angle of the length of the second portion 141" relative to the length of the first portion 141'. Such angles can be 15 degrees, 30 degrees, 45 degrees, 60 degrees, 75 degrees, 90 degrees, 105 degrees, 120 degrees, 135 degrees, 150 degrees, 165 degrees, 180 degrees, 195 degrees, 210 degrees, 225 degrees, 240 degrees, 255 degrees, 270 degrees, 285 degrees, 300 degrees, 315 degrees, 330 degrees, 345 degrees, or 360 degrees. In particular, the angle between the first portion 141' and the second portion 141" can be defined as the angle in planes P1 and P2, or as the angle in a plane parallel to the tissue portion 610 when the remote unit 140 is implanted. In the embodiment shown in Figures 58A-58D, the length of second portion 141'' is angled at 0 degrees, 90 degrees, 180 degrees, and 270 degrees relative to the length of first portion 141'.

[0384] Second end 634 of second portion 141'' can define one or more connections for connecting to an implant located caudally from the location of the remote unit in the patient. This allows the connections to be closer to the implant when remote unit 140 is implanted in a patient, preferably with distal region 640 and second end 634 facing downward in a standing patient, since first end 632 faces cranially and second end 634 faces caudally. Second end 634 of second portion 141'' can also be configured to connect to an implant, i.e., second end 634 can define a port, connector, or other type of connection element for transmitting power and / or signals.

[0385] Similarly, first end 632 of second portion 141'' can define one or more connections for connecting to an implant located cranially from the location of the remote unit in the patient. This allows for connections to be closer to the implant when remote unit 140 is implanted in a patient, preferably with distal region 640 and second end 634 pointing downward in a standing patient, with first end 632 facing cranially while second end 634 faces toward the coccyx. First end 632 of second portion 141'' can also be configured to connect to an implant, i.e., first end 632 can define a port, connector, or other type of connection element for transmitting power and / or signals.

[0386] 60 and 61 , an embodiment of an implantable remote unit 140 is described. Referring to Figures 60 and 61 , an embodiment of an implantable remote unit 140 is described. The remote unit 140 is configured to be held in place by a tissue portion 610 of a patient. The remote unit 140 includes a first portion 141′ configured to be disposed on a first side 612 of the tissue portion 610, the first portion 141′ having a first cross-sectional area in a first plane and including a first surface 614 configured to face and / or engage a first tissue surface 616 of the first side 612 of the tissue portion 610. The remote unit 140 further comprises a second portion 141″ configured to be disposed on a second side 618 of the tissue portion 610, the second side 618 facing the first side 612, the second portion 141″ having a second cross-sectional area in a second plane and comprising a second surface 620 configured to engage a second tissue surface 622 of the second side 618 of the tissue portion 610. The remote unit 140 further comprises a connecting portion 142 configured to be disposed through a hole in the tissue portion 610 extending between the first and second sides 612, 618 of the tissue portion 610, the connecting portion 142 here having a third cross-sectional area in a third plane. The connecting portion 142 is configured to connect the first portion 141′ to the second portion 141″.

[0387] 62A , the first cross-sectional area has a first cross-sectional distance CD1a and a second cross-sectional distance CD2a, where the first and second cross-sectional distances CD1a, CD2a are perpendicular to each other, and the first cross-sectional distance CD1a is longer than the second cross-sectional distance CD2a. Furthermore, the second cross-sectional area has a first cross-sectional distance CD1b and a second cross-sectional distance CD2b, where the first and second cross-sectional distances CD2a, CD2b are perpendicular to each other, and the first cross-sectional distance CD1b is longer than the second cross-sectional distance CD2b. The first cross-sectional distance CD1a of the first cross-sectional area and the first cross-sectional distance CD1b of the second cross-sectional area are rotationally displaced relative to each other by an angle greater than 45° to facilitate insertion of second portion 141″ through the opening in the tissue portion. In the embodiment shown in FIG. 62A , the rotational displacement is 90°.

[0388] The rotational displacement of the first portion 141′ and the second portion 141″ is particularly advantageous in that it forms a cross-like structure, facilitating insertion through the hole in the tissue portion 610 and achieving a reliable position once positioned in the hole in the tissue portion 610. In particular, when the remote unit 140 is positioned such that the second portion 141″ has its first cross-sectional distance CD1b extending along the extension of the length of the hole 611 in the tissue portion 610, insertion of the second portion 141″ through the hole 611 may be facilitated. Furthermore, when the first portion 141′ is displaced relative to the second portion 141″ such that the first cross-sectional distance CD1a of the first portion 141′ is displaced relative to the extension of the length of the hole 611, the first portion 141′ may be prevented from moving through the hole 611 in the tissue portion. In such cases, it is particularly advantageous if the hole 611 in the tissue portion is oval, elliptical, or has at least one dimension longer than the other dimension. Such oblong holes in the tissue section may be formed, for example, in tissue having a fiber direction, with the longest dimension of the hole aligned with the fiber direction.

[0389] In the embodiment shown in FIG. 60, the first surface 614 of the first portion 141′ is flat, thus providing a larger contact area with the first tissue surface 616, resulting in less pressure on the tissue portion. A more stable position may also be achieved with a flat surface. The second surface 620 of the second portion 141″ may also be flat. However, other shapes are possible, as described elsewhere in this disclosure.

[0390] 62A, connecting portion 142 can have an elongated cross-section in the third plane. It can be particularly advantageous if connecting portion 142 has a length 644 that is greater than width 648, said length 644 extending in the same direction as the length of second portion 141'', i.e., the same direction as the elongation of second portion 141'', so that the elongation of connecting portion 142 can run in the same direction as the elongation of the hole in the tissue portion.

[0391] 62B, the rotational displacement between the first cross-sectional distance of the first cross-sectional area and the first cross-sectional distance of the second cross-sectional area is shown here at an angle of approximately 45°. Thus, there is a rotational displacement in the first, second, and third planes between the length direction 633 of the first portion 141' and the length direction 631 of the second portion 141''. Other angles of rotational displacement are possible, such as 60°, 75°, 90°, 105°, 120°, 135°, etc.

[0392] The same remote unit 140 can assume several different configurations with respect to the rotational displacement of the first portion 141′ and the second portion 141″. This is particularly possible when the first portion 141′ and / or the second portion 141″ are configured to be detachably connected to the interconnecting portion 142. For example, the connection mechanism between the first portion 141′ and the connecting portion 142, or between the second portion 141″ and the connecting portion 142, can have rotational symmetry that allows the first portion 141′ to be configured in different positions relative to the connecting portion 142 and, by extension, also in different positions relative to the second portion 141″. Similarly, such rotational symmetry can allow the second portion 142″ to be configured in different positions relative to the connecting portion 142 and to be extended relative to the first portion 141′.

[0393] 63A to 63C, the procedure for inserting the remote unit 140 into the tissue portion 610 will be described. The remote unit 140 can be oriented so that the length direction 631 of the second portion 141'' faces downward into the hole 611. Preferably, the second portion 141'' is positioned so that it is inserted near the edge of the hole 611. The second portion 141'' can then be partially inserted through the hole 611 up to the point where the first portion 141' contacts the first tissue surface 616. Here, as described above, by providing a 90° rotational displacement between the first portion 141' and the second portion 141'', a relatively large portion of the second portion 141'' can be inserted before the first portion 141' abuts the first tissue surface 616. Thereafter, the remote unit 140 can be rotated to insert the remaining portion of the second portion 141''. It can be slid or inserted through hole 611. While inserting the remainder of second portion 141'', the tissue may naturally flex and move to make way for second portion 141''. When second portion 141'' is fully inserted through hole 611 so that second portion 141'' is fully opposite tissue portion 610, the tissue can naturally flex back.

[0394] 64 , an embodiment of an implantable remote unit 140, sometimes referred to as a remote unit in other portions of this disclosure, is described. The remote unit 140 is configured to be held in place by a tissue portion 610 of a patient. The remote unit 140 includes a first portion 141′ configured to be disposed on a first side 612 of the tissue portion 610, the first portion 141′ having a first cross-sectional area in a first plane and including a first surface 614 configured to face and / or engage a first tissue surface on the first side 612 of the tissue portion 610. The remote unit 140 further includes a second portion 141″ configured to be disposed on a second side 618 of the tissue portion 610, the second side 618 facing the first side 612, the second portion 141″ having a second cross-sectional area in a second plane and including a second surface 620 configured to engage a second tissue surface on the second side 618 of the tissue portion 610. The remote unit 140 further includes a connecting portion 142 configured to be disposed through a hole in the tissue portion 610 extending between the first and second sides 612, 618 of the tissue portion 610, where the connecting portion 142 has a third cross-sectional area in a third plane. The connecting portion 142 is configured to connect the first portion 141′ to the second portion 141″.

[0395] At least one of the first and second portions comprises at least one coil embedded in a ceramic material, the at least one coil configured for at least one of receiving wirelessly transmitted energy, wirelessly transmitting energy, receiving wireless communications, and transmitting wireless communications. In the illustrated embodiment, the first portion 141' comprises a first coil 658 and a second coil 660, and the second portion 141'' comprises a third coil 662. The coils are embedded in a ceramic material 664.

[0396] As discussed elsewhere in this disclosure, first portion 141' may comprise a first wireless energy receiver configured to receive energy wirelessly transmitted from an external wireless energy transmitter, and first portion 141' may further comprise a first wireless communication receiver. The first wireless energy receiver and the first wireless communication receiver may comprise a first coil. Thus, the first coil may be configured to wirelessly receive energy and / or wirelessly receive communications.

[0397] By the expression "a receiver / transmitter comprising a coil" it is to be understood that said coil may form part of the receiver / transmitter.

[0398] First portion 141′ comprises a distal end 665 and a proximal end 666, here defined relative to connecting portion 142. In particular, proximal end 665 is positioned closer to connecting portion 142 and closer than second portion 141″ when remote unit 140 is assembled. In the illustrated embodiment, first coil 658 is positioned at distal end 665.

[0399] First portion 141′ can comprise an internal wireless energy transmitter and further a first wireless communication transmitter. In some embodiments, the internal wireless energy transmitter and / or the first wireless communication transmitter is comprised of first coil 658. However, in some embodiments, the internal wireless energy transmitter and / or the first wireless communication transmitter is comprised of second coil 660. Second coil 660 is here disposed at proximal end 665 of first portion 141′. Such a placement of second coil 660 can provide that the energy and / or communication signal transmitted by second coil 660 is not attenuated by internal components of first portion 141′ when transmitted to second portion 141″.

[0400] In some embodiments, the first wireless energy receiver and the internal wireless energy transmitter are comprised of a single coil embedded in a ceramic material. Thus, the single coil may be configured to wirelessly receive energy and wirelessly transmit energy. Similarly, the first wireless communication receiver and the first wireless communication transmitter may be comprised of a single coil embedded in a ceramic material. Furthermore, in some embodiments, the single coil may be configured to wirelessly receive and transmit energy and wirelessly receive and transmit communication signals.

[0401] The coils discussed herein are preferably disposed in a plane that extends substantially parallel to the tissue portion 610 .

[0402] The second portion 141'' can comprise a second wireless energy receiver and / or a second wireless communication receiver. In some embodiments, the third coil 662 in the second portion 141'' comprises a second wireless energy receiver and / or a second wireless communication receiver.

[0403] Second portion 141″ comprises a distal end 668 and a proximal end 670, here defined relative to connecting portion 142. Notably, proximal end 668 is positioned closer to connecting portion 142 and closer than first portion 141′ when remote unit 140 is assembled. In the illustrated embodiment, third coil 662 is positioned at proximal end 668 of second portion 141″. Such positioning of third coil 662 may provide that energy and / or communication signals received by third coil 662 are not attenuated by internal components of second portion 141″ when received from first portion 141′.

[0404] The first portion 141′ may be comprised of a first controller 300a connected to the first coil 658, the second coil 660, and / or the third coil 662. The second portion 141″ may be comprised of a second controller 300b connected to the first coil 658, the second coil 660, and / or the third coil 662.

[0405] In the illustrated embodiment, the first portion 141′ comprises a first wireless energy receiver 308a, i.e., a first energy storage unit 304a connected to the first coil 658. The second portion comprises a second wireless energy receiver 308b, i.e., ...

Claims

1. An apparatus for treating gastroesophageal reflux disease in a human patient, configured to at least partially surround the esophagus of the human patient, comprising a first implantable portion having a shape and size that is configured to rest against the fundic wall portion of the stomach of the human patient and that is arranged to be at least partially invaded by the fundic wall portion, wherein the first implantable portion is implanted at a position between the diaphragm and the lower portion of the fundic wall of the human patient, restricting the movement of the cardia of the patient's stomach towards the diaphragm side, preventing the cardia from slipping into the patient's thoracic cavity through the diaphragmatic opening, comprising a second implantable portion that is elongated to at least partially surround the esophagus and that has a variable length to enable the apparatus to be arranged in a contracted state for preventing the passage of fluid from the stomach to the esophagus and in an expanded state for enabling the passage of food to the stomach in response to swallowing by the human patient, wherein at least one of the first implantable portion and the second implantable portion comprises a plurality of bodies configured to be arranged annularly around the esophagus, the apparatus further comprising an attractor for elastically attracting adjacent ones of the bodies to each other, the attractor comprising at least one of a magnet, an elastic member, and a spring apparatus.

2. The first implantable portion has a shape that is substantially fixed during operation of the apparatus The apparatus according to claim 1.

3. The maximum width of a cross-section across the longitudinal direction of the first implantable portion is greater than the maximum width of a cross-section across the longitudinal direction of the second implantable portion The apparatus according to claim 1 or 2.

4. The second implantable portion is configured to enable a transition from a contracted state caused by food passing through the esophagus to an expanded state The device according to claim 1 or 2.

5. The device according to claim 1 or 2, wherein the attractor comprises at least a first magnet and a second magnet attracting each other.

6. Further comprising a link connecting the first magnet and the second magnet to each other The device according to claim 5.

7. The link is configured to extend into at least one of the magnets in response to the magnets moving towards each other The device according to claim 6.

8. Further comprising a tubular cover surrounding at least a part of the second implantable part, the tubular cover being adapted to bend relative to each other so that the second implantable part can change between a contracted state and an expanded state without being substantially hindered or inhibited by the presence of the fibrous tissue when at least partially covered by the fibrous tissue, and including a plurality of cover parts The device according to claim 1 or 2.

9. The tubular cover is formed of a non - elastic material The device according to claim 8.

10. The tubular cover has a biocompatible outer surface for long - term implantation The device according to claim 8.

11. The tubular cover is configured to abut against the outer surface of the esophagus The device according to claim 8.

12. The tubular cover has a surface that promotes tissue growth The device according to claim 8.

13. The tubular cover comprises at least one predefined fold line that allows the tubular cover to be folded in response to a change in the length of the second implantable portion. The device according to claim 8.

14. The tubular cover comprises a lowered portion and a raised portion that enable the length of the tubular cover to be changed while maintaining its surface area. The device according to claim 8.

15. The tubular cover is configured to be compressible and stretchable in its longitudinal direction. The device according to claim 8.

16. The length of the tubular cover surrounding at least a part of the second implantable portion exceeds the length of at least a part of the second implantable portion when at least a part of the second implantable portion is disposed in a contracted state. The device according to claim 8.

17. Including two end portions (216) configured to be coupled to each other to form a closed ring around the esophagus. The device according to claim 1 or 2.

18. The end portions are configured to be releasably attached to each other. The device according to claim 17.

19. The volume of the first implantable portion is non-adjustable. The device according to claim 1 or 2.

20. The volume of the first implantable portion is adjustable after implantation. The device according to claim 1 or 2.

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