MX2011007881A

MX2011007881A - An apparatus for treating gerd.

Info

Publication number: MX2011007881A
Application number: MX2011007881A
Authority: MX
Inventors: Peter Forsell
Original assignee: Milux Holding Sa
Priority date: 2009-01-29
Filing date: 2010-01-29
Publication date: 2011-11-29
Also published as: CA3109506A1; CA2788408A1; MX357949B; AU2010208684A1; AU2010208684B2; CA2788408C

Abstract

The present invention relates to a reflux disease treatment apparatus, comprising two or more movement restriction device segments adapted to form an implantable movement restriction device with an elongated shape that maintains cardia in the correct position. The movement restriction device has proximal and a distal end, wherein the distal end is adapted to stabilize and hold the proximal end. The invention further comprises a control device for controlling the stimulation device to stimulate the cardia sphincter. The distal end can be further adapted to treat obesity, for example by stretching the wall of the stomach or filling out a volume of the stomach.

Description

AN APPARATUS FOR THE TREATMENT AGAINST DISEASE BY REFLUX GRASTROESOFAGICO (GERD) Field of the Invention The present invention relates to an apparatus for treating Gastroesophageal Reflux Disease (GERD).

The present invention relates to an apparatus for the treatment against reflux disease, comprising an implantable elongated motion restriction device having a proximal part that maintains the sphincter called cardia in the correct position and a distant part that stabilizes the part next and can be adapted to further treat obesity. The apparatus may further comprise an implantable stimulation device adapted to engage the cardiac sphincter of a patient and a control device for controlling the stimulation device for stimulating the cardia sphincter. The invention can be further combined with various methods of treating obesity, particularly methods that create satiety by stretching the stomach wall or filling a stomach volume.

Background of the Invention Gastroesophageal Reflux Disease (GERD), or acid reflux disease, is a chronic condition that results in damage to the mucosa in the esophagus produced by the recurrent occurrence of acid reflux in the esophagus. This is commonly due to transient or permanent changes of the barrier between the esophagus and the stomach. This may be due to incompetence of the lower esophageal sphincter (LES), to transient SLE relaxation, to decreased expulsion of gastric reflux from the esophagus, or to a hiatal hernia.

Gastroesophageal Reflux Disease can be treated in a variety of different ways. The treatments include, among other things, both medical treatment and surgeries. A conventional surgery, which is sometimes preferred over prolonged use of medication, is Nissen fundoplication surgery, where the upper curve of the stomach (the fundus) is wrapped around the LES to reinforce the sphincter and prevent acid reflux and repair a hiatal hernia The procedure is often done laparoscopically.

Another surgical treatment that has been used is the Anglechik prosthesis, where a device formed as a horseshoe is placed around the esophagus above the cardia. The proposed effect is to prevent the cardia from slipping into the chest cavity. However, this device has several complications, which includes passing through, and damage to the esophagus.

From experience with implanting devices Doctors, it is known that sutures between an implanted device and a human tissue will not be maintained in the long term. For the long-term implant of a device, there are two possibilities to keep the device in place. A first solution has been to suture human tissue to human tissue, to keep the device in place. A second method has been to provide sutures that hold a device in place in the short term and to allow the growth of human tissue in the device to keep the device in place in the long term.

A problem with the provision of an implantable device associated with the esophagus is that the outer surface of the esophagus only consists of the muscle tissue of the esophagus, which is very easy to damage or pass. This is probably one reason why the Anglechik prosthesis described above has resulted in many complications, such as migration.

The stomach, on the other hand, has a serous membrane on its outside, thus providing a much more powerful membrane for suturing. In this way, suturing a device directly to the stomach wall provides a better result than suturing a device implanted to the esophagus.

At present, long-term GERD treatment is needed that is more effective than previous treatments and that does not result in any serious complications.

Brief Description of the Invention It is an object of the present invention to overcome, or at least reduce, some problems associated with existing surgical treatments for Gastroesophageal Reflux Disease (GERD). It is another object of the present invention to provide an apparatus for treating Gastroesophageal Reflux Disease. These objects and others are obtained by the apparatus described in the appended claims.

An object of the present invention is to provide an apparatus for the treatment of reflux disease with improved long-term properties which may also be further provided with obesity treatment functions.

This object and others are obtained by an apparatus described in the appended claims. In general terms, the present invention relates to an apparatus for treating reflux disease in a mammalian, human or animal patient comprising two or more segments of the movement restriction device to form an implantable restriction device having a external surface with an elongated shape adapted to be at least in part invaginated by a portion of the stomach wall of a patient. The movement restriction device has, when implanted in a patient, a proximal portion and a distal portion, and the device is adapted to rest at least partially with the outer surface of its proximal portion against the fundus wall of the stomach of the patient. patient, in a position between the diaphragm of the patient and the fundus wall, such that the movement of the cardiac notch of the patient's stomach towards the diaphragm of the patient is restricted, when the motion restriction device is implanted in the patient, for thus preventing the heart from sliding through the diaphragm opening of the patient in the patient's chest, to maintain the support pressure against the patient's cardiac sphincter muscle exerted from the patient's abdomen. The device is also adapted to stabilize and maintain. the proximal part by the distal portion adapted to be substantially invaginated in the wall of the stomach in order to prevent the heart from slipping through the opening of the patient's diaphragm into the patient's chest. The terms proximal and distant have the usual anatomical meaning. Therefore, close as an anatomical position means closer to the center of the body, or to the beginning of a structure. In the present near and distant context they refer to parts of the movement restriction in its implanted position. The length of the invaginated part distant from the elongated motion restriction device is sufficiently long to stabilize the proximal portion of the elongated motion restriction device to prevent the heart from sliding through the diaphragm opening of the patient in the patient's chest. The circumference of the invaginated part distant from the elongated motion restriction device is such that this stabilizes the proximal portion of the elongated motion restricting device to prevent the heart from sliding through the diaphragm opening of the patient in the patient's chest. The proximal part of the movement restriction device has a size of at least 125 mm3 and a circumference of at least 15 mm.

Preferably, the apparatus comprises a first implantable fixation device that secures the proximal portion of the movement restriction device in a position that restricts the movement of the cardiac notch in the stomach towards the diaphragm of the patient, with the external surface of the movement restriction that substantially contacts the fundus wall of the patient's stomach. The first fixation device may include sutures or staples that join together portions of the fundus wall of the stomach which enclose the proximal part of the movement restriction device to secure the movement restriction device in its position, i.e., the movement restriction device is at least partly placed in an invaginated space. In this way, when fixing the proximal part of the implantable movement restriction device indirectly in this way, suture is not required between the movement restriction device and the tissue, which, in turn, further reduces the risk of complications. Care of the proximal portion of the movement restriction device in its place in this manner has resulted in an elastic suspension with improved long-term properties ÷ The first fixation device, such as sutures or staples, joins together portions of the fundus wall of the stomach to invaginate the proximal portion of the movement restriction device of either the interior or exterior wall of the patient's stomach.

Alternatively, a tissue growth promoting structure can be sutured to the stomach wall with relatively greater contact surface towards the stomach. The relatively larger surface of the structure, such as a network, will allow for the inward growth of human tissue to keep the proximal portion of the movement restriction device in place long term. The tissue growth promoting structure may comprise sutures or staples that link the network-like structure to the wall of the fundus of the stomach.

In addition to fixing the proximal part of the movement restriction device to the stomach wall, a second fixation device can be used. The second fixation device can be used to fix the proximal part of the movement restriction device relative to the cardia. For example, the proximal part of the movement restriction device can be fixed in a position greater than the cardia, between the cardia and the diaphragm muscle, by a second direct or indirect fixation of the proximal part of the movement restriction device through of the fundus wall of the stomach. The second fixation device can indirectly or directly secure the proximal part of the movement restriction device to the esophagus near the angle of the patient's His. The second fixation device suitably includes a plurality of sutures or staples joining the wall of the fundus and a wall of the patient's esophagus to maintain the movement restriction device in place.

The apparatus may also comprise a third fixation device that secures, indirectly or directly, the proximal portion of the device restriction of movement to the diaphragm muscle of the patient or other muscle tissue. The third fixation device comprises approximately a plurality of sutures or staples that join the wall of the fundus and the muscle of the diaphragm or other muscle tissue to maintain the movement restriction device in place.

The proximal portion of the movement restriction device may be adapted to be substantially or completely invaginated by the fundus wall of the patient's stomach, and placed inside or outside the fundus wall of the stomach.

The proximal portion of the movement restriction device can be adapted to be positioned outside the wall of the patient's stomach, such that the stomach cavity is substantially reduced, by a volume that substantially exceeds the volume of the movement restriction device.

At least a part of the proximal part of the movement restriction device can be made of a material that is destructible or non-destructible by stomach acid.

In one embodiment, the proximal portion of the movement restriction device is inflatable and adapted to be inflated with a gel or fluid. A fluid or gel receiving member can be provided to receive the fluid for inflate the motion restriction device.

The proximal part of the movement restriction device can include a homogeneous material and can be a solid body.

The proximal part of the movement restriction device may include an enclosing wall defining a chamber.

The proximal part of the movement restriction device can have a rigid, elastic or flexible outer wall. Where the outer wall is rigid, it is sufficiently rigid to maintain non-deformed when subjected to forces created by movements of the stomach.

According to a preferred embodiment of the apparatus, the proximal portion of the movement restriction device comprises a body adapted to be at least partly invaginated by the fundus wall of the patient's stomach and which has an external surface that includes a material biocompatible A considerable part of the external surface of the body is adapted to rest against the wall of the stomach in its position between the diaphragm of the patient and the portion of the lower part of the wall of the fundus of the invaginated stomach. Properly, the body is made of a softer material than 25 or 15 Shore.

According to a first general design of the body, the body has a maximum circumference as observed in a plane perpendicular to an axis through the body. The circumferences of the body as observed in other planes perpendicular to the axis are equal to the maximum circumference or decrease as observed along the axis in the direction of the maximum circumference. For example, the body may be substantially egg-shaped, spherically shaped, or substantially shaped like an egg with a serrated intermediate section or as a bent egg.

According to a second general design of the body, the circumference of the body as observed in a plane perpendicular to an axis through the body increases and decreases at least twice as the plane travels along the axis, or decreases in increases at least once as the plane moves along the axis. For example, the body can be substantially shaped like a kidney.

Preferably, the body is dimensioned with a larger size than the intestinal outlet of the stomach. The body may have the smallest outer diameter of 30 or 40 mm or greater and may have a smaller outer circumference of 150, 110, 90, 70, 50 or 30 mm.

Properly, the body has rounded contours without too sharp edges that would be harmful to the patient's stomach wall, and have a generally smooth external surface to lean against the wall of the fundus.

The body can be implanted either inside or outside the patient's stomach and is attached to the patient's stomach wall by surgery. The body can be changeable to assume a thin shape having a diameter smaller than that of a trocar for laparoscopic use, whereby the body when changed to the thin shape can be pushed or removed through the trocar. The body may include a flexible outer wall that defines a chamber filled with a fluid, such as a gel, allowing the body to pass through the trocar. Alternatively, the body may include an elastic compressible material, allowing the body to pass through a trocar.

The body may be hollow and include at least two separate product units adapted to be inserted into the hollow body, and additionally adapted to be assembled to a unit product unit within the body, thereby allowing the body to pass through a body. trocar for laparoscopic use. Alternatively, the body may include an outer wall and a hollow compressed internal part, to be filled with a fluid or gel after insertion into the body of a body. patient.

The body may include a chamber with an injection orifice, wherein the body chamber is filled with a fluid through the injection port.

The body may include at least one support device adapted to be used to push or withdraw the body through a trocar for laparoscopic use. The support device is adapted to maintain a prolongation of the body that is adapted to be maintained by a surgical instrument. More specifically, the holding device is adapted to maintain a thread or band inserted through the holding device. Where the body comprises an external wall the support device is at least in part placed inside the external wall of the body.

In one embodiment, the apparatus according to the invention further comprises an adjustment device for adjusting at least the proximal part of the movement restriction device. For this purpose, the movement restriction device may comprise a body, the size of which is hydraulically adjustable, and the adjustment device may comprise a reservoir of hydraulic fluid which, when implanted in the patient, is connected to the body, and where the body size is non-invasively regulated by manually pressing the reservoir of hydraulic fluid to adjust the amount of hydraulic fluid supplied to the body and thus the size of the body. The apparatus may further comprise a hydraulic regulating device comprising at least one chamber which, when implanted in the patient, invaginates into the wall of the patient's stomach with the body and is connected to the body, and where the amount of Hydraulic fluid contained in the body is non-invasively regulated by distributing the fluid between the hydraulic reservoir and the at least one chamber. Preferably, the at least one chamber, when implanted in the patient, is filled with the hydraulic fluid using a pump in the reservoir to stretch the fundus wall to create satiety in the patient. Additionally, the adjustment device may further comprise a reverse servomechanism, wherein a small volume of fluid in the reservoir is compressed with a higher force and the chamber forms a movement of a larger total volume with less force per unit of volume. In one embodiment, the body forms a first chamber, which also comprises at least one additional body forming a second chamber smaller than the first chamber, the first and second chambers being in contact with each other, preferably in fluid communication each. The hydraulic reservoir is preferably adapted to be placed subcutaneously in the patient and the hydraulic reservoir is preferably adapted to be placed on the patient's abdomen. The hydraulic reservoir may have a wall that defines the volume thereof, and the volume of the hydraulic reservoir is regulated by the movement of a portion of the wall of the wall of the hydraulic reservoir. The apparatus may comprise a motor for the movement of the portion of the wall. The hydraulic regulating device may comprise a pump, and the hydraulic reservoir is regulated by the pump that pumps the fluid between the hydraulic reservoir and the at least one chamber. A mechanical device can be functionally connected to the hydraulic regulating device to be moved as the hydraulic regulating device is operated. In one embodiment, at least the proximal part of the movement restriction device is mechanically regulated. The apparatus may further comprise a motor for mechanically regulating the motion restriction device.

In one embodiment, the apparatus further comprises a second body which, when implanted in the patient with the body, fills two volumes, respectively, with two different parts of the patient's stomach, thereby affecting the reflux of the patient. The reflux disease treatment device is adapted to be post-functionally and non-invasively regulated, and adapted to regulate from time to time such that in a first time one of the filling bodies fill the volume to one part of the stomach and in a second time the other filling bodies fill the volume in the other part of the stomach.

In one embodiment, the apparatus according to the invention comprises an adjustment device for adjusting the size and / or shape of the movement restriction device. The size of the movement restriction device may be hydraulically adjustable, and the adjustment device may comprise a reservoir of hydraulic fluid which, when implanted in the patient, is connected to the motion restriction device, and the size of the restriction device. Movement can be non-invasively regulated by the mobile hydraulic fluid between the hydraulic fluid reservoir and the movement restriction device. The movement restriction device can be observed as a body. The apparatus may further comprise a hydraulic regulating device comprising at least one chamber which, when implanted in the patient, invaginates into the wall of the patient's stomach with the body and is connected to the body, and where the amount of Hydraulic fluid contained in the body is non-invasively regulated by distributing the fluid between the hydraulic reservoir and the at least one camera. The at least one chamber, when implanted in the patient, can be filled with hydraulic fluid by using a pump in the reservoir to stretch the fundus wall to create satiety in the patient. Additionally, the adjustment device may comprise an inverse servomechanism comprising three reservoirs adjustable with the hydraulic fluid, wherein a small volume of fluid in a first reservoir placed subcutaneously, the part of a first closed system including a second reservoir, is compresses with a high power per unit area to move a small volume of hydraulic fluid, and where the second tank affects a larger volume of hydraulic fluid in a third tank, the third tank which is part of a second closed system that has the volume greater than the first tank, thereby creating a movement of a larger total volume of the hydraulic fluid with less force per unit area.

In a special embodiment, the motion restoration device as detailed in the preceding sections comprises two or more segments of the motion restriction device, preferably comprising more than three segments, adapted to be assembled to a motion restriction device. Implantable assembly of a controlled size involving at least the proximal part of the restriction device of movement. The assembled movement restriction device is adapted to be supported with at least a portion of its external surface against the fundus wall of the patient's stomach, in a position between the patient's diaphragm and the wall of the fundus, such that the movement of the cardiac notch of the patient's stomach towards the diaphragm of the patient, when the motion restriction device is implanted in the patient, to prevent the heart from slipping through the patient's diaphragm aperture in the patient's chest, to maintain support pressure against the cardiac sphincter muscle exerted on the patient's abdomen. The assembled motion restriction device is preferably adapted to disassemble into its segments if it leaves its implanted position at least partially contacting the fundus wall of the stomach at a position between the diaphragm and the wall of the fundus. Preferably, the assembled movement restriction device is adapted to be invaginated in the stomach wall, and disassembled in its segments if it leaves its position implanted in the stomach which includes penetrating the stomach wall to maintain a position within the stomach . The segments are preferably adapted to pass separately through the food passage, thus reducing the risk of causing obstruction / ileus in the patient's intestine. The segments of the movement restriction device can be adapted to pass through a trocar, for the assembly and implantation of the movement restriction device in the abdominal cavity. The segments of the movement restriction device may have a flexible external shape adapted to pass through a trocar. The segments of the movement restriction device can be adapted to have a shape that allows them to be assembled in the movement restriction device, when implanted. In one embodiment, the segments of the movement restriction device are hollow with a flexible outer surface. The segments of the movement restriction device can be adapted to fill with a foam, a gel or a fluid that hardens to a solid material with at least one of a fluid. In one embodiment the segments of the motion restriction device are solid. It is preferred that the segments of the movement restriction device be temporarily adapted to maintain their assembled position, preferably by the invaginated stomach wall or alternatively by an adhesive.

For assembly, the movement restriction device is provided with at least one assembly element that is sufficiently adjusted with at least one element of. assembly of another segment, then the segments when adjusting the assembly elements can be assembled in the implantable movement restriction device. Preferably, the segments for this purpose comprise a main part and a plurality of external parts, and preferably, the at least one assembly element is selected from tabs and grooves that fit sufficiently. The main part is adapted to receive and assemble the external elements in an implantable movement restriction device, and preferably the main part has assembly slots to receive the corresponding assembly tabs of the external parts when assembling the restriction device of movement. In one embodiment the slots are distributed around the outer peripheral area of the main part. The external parts are provided with tabs that engage sufficiently with the slots to assemble the device. In another embodiment, the at least one assembly element immobilizes each of the segments of the motion restriction device to a main part along a first plane, and wherein the movement, and wherein the segments of the device of motion restriction and the main part also comprise a second assembly element, which following the unit of segments and part main, immobilize each segment and main part along a second plane at an angle to the foreground. For example, the first plane and the second plane may be substantially perpendicular. The second assembly element comprises coupling elements, preferably with coupling protrusions and cavities provided in the segments of the movement restriction device and the main part, while the at least one assembly element further comprises protuberances and cavities. Preferably, the at least one assembly element comprises an assembly groove in the main part and an assembly flange in a segment, and wherein a coupling element comprises a protrusion in the groove and a cavity in the flange; or alternatively, the at least one assembly element comprises an assembly flange in the main part and an assembly groove in a segment, and wherein a coupling element comprises a protrusion in the groove and a cavity in the flange.

In a particular embodiment, the apparatus preferably further comprises a guiding device operable to assemble the segments of the movement restriction device to an implantable movement restriction device. Preferably, the guide device is an operating wire functionally connected to the segments.

The operating wire can be made of a material that is biodegradable in contact with the body fluid in the abdominal cavity to facilitate the removal of the movement restriction device in its segments. In order to assist with the assembly procedure, each segment can be provided with at least one assembly element that sufficiently fits with at least one assembly element of another segment, then the segments when adjusting the assembly elements can be assembled in the implantable movement restriction device. In one embodiment, the segments comprise a main part and a plurality of external parts and in a mode wherein the assembly elements are selected between tabs that fit sufficiently and slots.

The main part is preferably adapted to receive and assemble the external elements in an implantable movement restriction device. In one embodiment the main part has assembly slots adapted to receive corresponding assembly tabs from the external parts when assembling the motion restriction device. Preferably, the slots are distributed around the outer peripheral area of the main part. The slots and tabs can be designed to have a free fit adapted to maintain the segments with a device like restriction of movement to its implanted location, but assist with the disassembly of the device if it accidentally leaves such position, for example to the cavity of the stomach. In such a case the degradation of the guiding device will also assist with the dismounting of the movement restriction device in segments that are not designed to cause any obstruction or in any other way harm the patient.

In order to assemble the segments, the operating wire is connected to the main part and to the external parts so that the external parts can be sequentially assembled to the main part to assemble the motion restriction device. For this purpose, the operating wire is preferably connected to the assembly flanges of the external part and preferably, the main part is provided with at least one operating channel for receiving the operating wire. Preferably, each external part is connected to two operating channels by the operating wire. In one embodiment, a first operating channel has a first hole in a terminal surface of the main part and a second hole in a first slot of the main part, then when moving the wire of operation received in the first operating channel in a direction of the terminal surface, a first part external to the main part is mentioned. A second operating channel has two orifices in a second slot of the main part, then by displacing the operating wire connected with the first cannel operation to a directed one of the terminal surface, a second external part is assembled to the main part. Preferably, the guide wire protrudes from the first channel hole so that it can be operated with an instrument for moving the guide wire and a first external element so that its assembly flange fits with its first assembly slot designated in FIG. the main element, and in a predetermined sequence in the same manner as it displaces the remaining external elements to assemble the implantable movement restriction device. The segments may comprise three or more external parts assembled to grooves designated from the main part with the guide wire through the operating channels having holes in each designated slot of the main part. In one embodiment, the movement restriction device comprises a main part and four external parts. However, other ways of designing the segments within the present concept are feasible according to the expert person. The device Restriction of movement in this assembled manner can maintain a generally spherical shape, but as will be described later, other forms and additional function elements become part of the present invention.

Other features of the proximal part of the movement restriction device will be described in the following part of the description. These features may be combined with any of the features that remain related to the distant part of the motion restriction device.

In an advantageous embodiment of the apparatus now adapted to also treat obesity, the body is adjustable in size and invaginated in the fundus wall of the patient's stomach. As a result, the body stretches the fundus wall of the patient's stomach when the patient's stomach size increases, thereby creating satiety in a patient who also suffers from obesity. At least two implantable adjustable stretch devices can be provided to stretch different portions of the patient's stomach wall, to thereby treat obesity by effectively affecting the patient's appetite. The two stretching devices are suitably regulated from outside the body of a patient, whereby a first of the stretching devices is adjusted a first time to stretch a First part of the stomach wall of the patient and a second of the stretching devices is adjusted a second time to stretch a second part of the patient's stomach wall.

The apparatus of the present invention in any way detailed in the preceding sections can be further adapted to treat obesity in conjunction with reflux disease since it is common for a patient to suffer from both complications. For this purpose the distal part of the movement restriction device is further adapted for the treatment of obesity. The distant part will have the functionality of a volume filler device According to a first option, the distal portion of the movement restriction device is adapted to be placed within the stomach with the outer surface of the distal portion leaning against the inside of the stomach wall.

According to a second option, the distal portion of the movement restriction device is adapted to be positioned outside of the stomach with the external surface of the volume filler device resting against the outside of the stomach wall.

Preferably, the distal portion of the movement restriction device is adapted to be completely invaginated by the wall of the patient's stomach and placed inside or outside the wall of the stomach through a gastroscopic instrument. To this end, the distal portion of the movement restriction device may comprise a joining device adapted to cooperate with a grasping instrument. Suitably, the distal portion of the movement restriction device is adapted to be non-invasively post-functionally adjustable.

The apparatus may comprise a fixation device, suitably two or more fixation devices, adapted to be involved in securing the distal portion of the movement restriction device to the stomach wall. The remote part of the movement restriction device may comprise a holding device adapted to be maintained by an instrument, suitably two or more maintenance devices, to simplify the implantation of the device.

At least a part of the distal part of the movement restriction device can be made of a material that is not destructible by stomach acid. The distal part of the movement restriction device can be destructible by acids, for example hydrochloric acid.

In one modality, the distant part of the The motion restriction device is inflatable to an expanded state and comprises an enclosing wall defining a chamber, the distal portion of the motion restricting device is inflated with a gel or fluid supplied in the chamber. At least one tube may be connected to the distal portion of the movement restriction device to deliver the gel or fluid to the chamber. An injection orifice connectable with the tube can be provided. Alternatively, the distal portion of the movement restriction device may be provided with an inlet port for a fluid or a gel connectable to a gastroscopic instrument, wherein the inlet port comprises a fluid connection adapted to interconnect the inflatable device and the gastroscopic instrument. .

The distal portion of the movement restriction device may include a homogeneous material, such as the gel having a Shore value less than 15. The device may also be a solid body.

At least one of the near distant portions of the movement restriction device may at least a portion comprising a rigid, elastic or flexible outer surface. Where the external surface is rigid, it is quite rigid to remain undeformed when subjected to forces formed by movements of the stomach. The distal portion of the movement restriction device may comprise a flexible, non-elastic material.

According to a first general design of the remote part of the movement restriction device, the device has a maximum circumference as observed in a plane perpendicular to an axis through the device. The circumferences of the device as observed in other planes perpendicular to the axis are equal to the maximum circumference or decrease as observed along the axis in the direction of the maximum circumference. For example, the device may be substantially egg-shaped, spherically shaped, or substantially shaped like an egg with a serrated intermediate section or as a folded egg.

According to a second general design of the device, the circumference of the device as observed in a plane perpendicular to an axis through the device increases and decreases at least twice as the plane travels along the axis, or decreases and they increase at least once as the plane moves along the axis. For example, the device can be substantially shaped like a kidney.

The distant part of the restriction device of movement has an elongated, rounded, bent and / or curved shape.

The distal portion of the movement restriction device has a circumference of at least 30. 50, 80, 120, 150, 180 or 220 mm.

The distal portion of the movement restriction device has a volume in the range of 0.0001 to 0.001 m3, or 0.00001 to 0.001 m3, or 0.00001 to 0.0002 m3. The volume of the volume filling device has a volume less than 0.0002 m3.

The distal portion of the movement restriction device may comprise at least two interconnectable portions adapted to be placed inside or outside the stomach as separate portions.

The distal portion of the movement restriction device may comprise an elastic material, a biocompatible material and / or silicone. Suitably, at least one of the remote and proximal portions of the motion restriction device is provided with at least one layer. For example, a metallic layer, a Parylene layer, a polytetrafluoroethylene layer or a polyurethane layer. The layers may comprise multiple layers in any order. Suitably, one of the layers can be made of metal, silicon or PTFE. The volume filling device may comprise a layer of external surface of silicone, polyurethane, Teflon, or polytetrafluoroethylene, metal, Parylene, PTFE or a combination thereof. The volume filler device may comprise an inner surface layer of silicone, polyurethane, Teflon, or polytetrafluoroethylene, metal, Parylene, PTFE or a combination thereof. Other combinations of layers include an inner surface layer of the polytetrafluoroethylene and an outer layer of the silicone, an inner surface layer of the polytetrafluoroethylene, an intermediate layer of the silicone, and an outer layer of Parylene, an inner surface layer of the polyurethane and an outer layer of silicone, and an inner surface layer of polyurethane, an intermediate layer of silicone, and an outer layer of Parylene.

The distal portion of the movement restriction device may comprise a fluid adapted to be transformed into a solid or fixed state. Such fluid may be the fluid or isotonic polyurethane. The fluid can comprise large molecules, such as iodine molecules, to prevent diffusion.

The distal portion of the movement restriction device may have a maximum circumference of at least 50 millimeters, preferably at least 80 millimeters. Suitably, the distal portion of the movement restriction device is deformable to a maximum diameter,. to be insertable in a laparoscopic trocar.

Preferably, the distal portion of the movement restriction device is adapted to be held in place by sutures or clips from stomach to stomach to invaginate the device in the stomach wall. Advantageously, the remote part of the movement restriction device has a varying circumference to better maintain itself in its invaginated place in the wall of the patient's stomach. Sutures or staples from stomach to stomach can be provided with fixation portions that show a structure adapted to be in contact with the stomach wall to promote human tissue growth to ensure long-term placement of the volume filler device attached to the stomach. stomach wall The structure may comprise a network-like structure.

In the embodiment of the invention, the apparatus comprises a stretching device positioned outside the stomach wall and adapted to stretch a portion of the stomach wall, thereby affecting the patient's appetite. Where the volume filling device is inflatable, the apparatus may comprise a fluid connection interconnecting the stretching device and the volume filling device.

The stretching device can be regulated hydraulically. In this case, a subcutaneously implantable hydraulic reservoir connected with the regulated hydraulic stretch device may be provided, whereby the regulated hydraulic stretch of the device, when implanted in the patient, is adapted to be non-invasively regulated using the reservoir fluid hydraulic. In one embodiment the regulated hydraulic stretch device is non-invasively regulated by manually pressing the hydraulic reservoir. Additionally, the movement restriction device suitably includes an inflatable body, and a pump and a chamber in fluid contact with the body are provided, wherein the pump regulates the hydraulic reservoir by pumping the fluid or air from the body to the body. camera .

The apparatus may include an implantable stimulation device that sends stimulation pulses to the cardiac muscle, especially to the cardiac sphincter muscle to stimulate the cardiac muscle and also close in consequential cardiac to further prevent reflux disease. The stimulation device comprises at least one conductor and at least one electrode that receives stimulation pulses and applies them to the cardiac sphincter muscle to stimulate the cardiac sphincter muscle.

The at least one electrode can also be left in place by the stomach-esophageal sutures or invagination in the stomach wall. The stimulus pulses can be sent as a train of pulses, where the train of pulses is repeated with a time of rest between them, the rest time that extends the rest between each pulse in the train of pulses. Preferably, the stimulation device sends several pulse trains in a row followed by a longer rest time than this between the pulse trains to let the muscle rest still maintain the closed cardia sphincter. The stimulation device can include an electronic circuit and a power source of preferentially adapted to incorporate the electronic circuit and power source.

The stimulation device preferably comprises at least one sensor for detecting a physical parameter of the patient or a functional parameter of the movement restriction device and an internal control unit for controlling the stimulation device.

Normally, the internal control unit controls the stimulation device in response to the sensor information.

A sensor that detects a contraction wave of the esophagus, or any other parameter correlated to the food intake, sends the information to the internal control unit and the internal control unit then ceases the stimulus in response to such sensor information.

The stimulation device can be controlled, at any time, by the patient.

This object is also obtained by providing an apparatus, the apparatus comprising an implantable movement restriction device having an elongated shape and having, when implanted in a patient, a proximal and a distant part, wherein the proximal part is adapted to be at least partly invaginated by the fundus wall of the patient's stomach and having an external surface that preferably includes a biocompatible material, wherein a considerable portion of the external surface of the proximal part of the patient's restriction device movement is adapted to lean against the wall of the stomach without injuring the stomach in a position between the diaphragm of the patient and at least a portion of the bottom part of the fundus wall of the invaginated stomach, such that the movement of the notch is restricted of the patient's stomach towards the diaphragm of the patient, when the movement restriction device invades gina, thus preventing the heart from sliding through the patient's diaphragm opening in the patient's chest, to maintain support pressure against the patient.

Cardiac sphincter muscle exerted from the patient's abdomen. The distal portion of the movement restriction device stabilizes and maintains the proximal portion and adapts to invaginate substantially in the stomach wall. The fundus wall of the stomach is more easily movable and is consequently stabilized by the distant part that invaginates in the stomach wall at least partially the bottom part of the fundus wall of the stomach. The proximal portion of the movement restriction device has a size of at least 125 mm3 and a circumference of at least 15 mm, further comprises an implantable stimulation device adapted to be coupled with the cardia sphincter of a patient, and a device for control to control the stimulation device to stimulate the cardia sphincter, where the stimulation of the cardiac sphincter is done with pulses of energy to increase the tone of the sphincter so that the cardia is closed and the control device is operable by the patient in that this can be configured from the operation, wherein the control device is additionally operable by the patient to adjust the stimulation device in the operation, wherein the operational state the stimulation device alternates continuously at a time when the patient does not swallow between one mode of operation, where the cardiac sphincter is stimulated with pulses of energy, and a rest mode, where the cardiac sphincter is not stimulated.

Motion restriction device The device for restricting movement of the apparatus will be described. It is to be understood that in the present context all the features, functionalities or adaptations described with the motion restriction device in this section are related to its proximal part, even if this is not explicitly stated. However, all features, modalities, or part of modalities as well as any method described in this application, where applicable, may be used for both the near and distant portions of the device.

The apparatus comprises an implantable motion restricting device having an external surface that includes a biocompatible material, wherein the motion restriction device is adapted to support at least a portion of its external surface against the wall of the fundus of the stomach of the patient, in a position between the diaphragm of the patient and the wall of the fundus, such that the movement of the cardiac notch of the patient's stomach is restricted towards the diaphragm of the patient, an apparatus is obtained to treat the Gastroesophageal Reflux Disease. The motion restriction device has a size of at least 125 mm3 and a circumference of at least 15 mm and restricts the movement of the cardiac notch of the patient's stomach towards the diaphragm of the patient which thus prevents the heart from sliding through the opening of the patient's diaphragm into the patient's chest, maintaining the support pressure against the cardiac sphincter muscle exerted on the patient's abdomen. The fixing device is adapted to secure the movement restriction device in its position.

By adapting the external surface of the implanted motion restriction device to lean against the fundus wall, there is a minimal risk of complications, such as the migration of tissue damage, because the fundus is less fragile than the esophagus.

In a first embodiment of the invention, the fixation device comprises sutures or staples that join together portions of the fundus wall of the stomach that enclose the movement restriction device to secure the movement restriction device in its position. That is, the motion restriction device is at least partly placed in an invaginated space. In this way, when fixing the implantable movement restriction device indirectly in this way, sutures are not required between the movement restriction device and the tissue, which, in turn, reduces additionally the risk of complications. Keeping the motion restriction device in place in this way has resulted in an elastic suspension with improved long-term properties.

The fixation device, such as sutures or staples, can jointly join portions of the fundus wall of the stomach to substantially or completely invagiate the movement restriction device of either the interior or exterior wall of the patient's stomach. Where the movement restriction device is placed outside the wall of the patient's stomach, the movement restriction device is invaginated by the fundus wall of the stomach such that the stomach cavity is substantially reduced, by a volume substantially exceeding the volume of the movement restriction device.

In a further embodiment of the invention, the fixation device comprises a first implantable fixation device that joins the movement restriction device in its position to the fundus wall, a second fixation device that indirectly or directly ensures the device of restriction of movement to the esophagus near the angle of His of the patient, and a third fixation device that secures, indirectly or directly, the device of restriction of movement to the muscle of the patient's diaphragm or associated muscles. Any of the first, second and third fixation devices may consist of a plurality of sutures or staples. The first fixation device may comprise a tissue growth promoting structure for the long-term attachment of the movement restriction device to the stomach wall. The tissue growth promoter structure can be sutured to the stomach wall with relatively greater contact surface towards the stomach. The relatively larger surface of the structure, such as a network, will allow inward growth of human tissue to keep the motion restriction device in place in the long term. The tissue growth promoting structure may comprise sutures or staples that link the network-like structure to the wall of the fundus of the stomach.

In addition to invaginating the motion restriction device according to the first embodiment of the invention, the second fixation device can be used to indirectly or directly secure the movement restriction device to the esophagus near the angle of the patient's His, and the third fixation device can be used to secure, indirectly or directly, the movement restriction device to the diaphragm muscle of the patient or other muscle tissue.

At least a part of the movement restriction device can be made of a material that is destructible or non-destructible by stomach acid.

The motion restriction device may be inflatable and adapted to be inflated with a gel or fluid. A fluid or gel receiving member can be provided to receive the fluid to inflate the motion restriction device provided.

The movement restriction device can include a homogeneous material and can be a solid body.

The motion restriction device may include an enclosing wall defining a chamber.

The movement restriction device may have a rigid, elastic or flexible outer wall. Where the outer wall is rigid, it is quite rigid where it remains undeformed when subjected to forces formed by movements of the stomach. Where the motion restriction device is invaginated, according to the first embodiment described above, the motion restriction device preferably comprises a body adapted to be at least partially invaginated by the fundus wall of the patient's stomach and having an external surface that includes a biocompatible material. A considerable part of the external surface of the body adapts to lean against the wall of the stomach in its position between the diaphragm of the patient and the portion of the lower part of the fundus wall of the invaginated stomach. Properly, the body is made of a softer material than 25 or 15 shore.

According to a second general design of the body, the circumference of the body as observed in a plane perpendicular to an axis through the body increases and decrease at least twice as the plane moves along the axis, or decreases and increases at least once as the plane moves along the axis. For example, the body can be substantially shaped like a kidney.

Preferably, the body is dimensioned with a larger size than the intestinal outlet of the stomach. He Body may have the smallest external diameter of 30 or 40 mm or greater and may have the smallest outer circumference of 150, 110, 90, 70, 50 or 30 mm.

Suitably, the body has rounded contours without too sharp edges that would be detrimental to the patient's stomach wall, and have a generally smooth external surface to lean against the fundus wall.

The body can be implanted either inside or outside the patient's stomach and is adapted to be fixed to the patient's stomach wall by surgery. The body can be changeable to assume a thin shape having a smaller diameter than that of a trocar for laparoscopic use, whereby the body when changed to the thin form can be pushed or removed through the trocar. The body may include a flexible outer wall that defines a chamber filled with a fluid, such as a gel, allowing the body to pass through such a trocar. Alternatively, the body may include an elastic compressible material, allowing the body to pass through a trocar.

The body may be hollow and include at least two separate product units adapted to be inserted into the hollow body, and further adapted to be joined to a unit product unit within the body, thus allowing the body to pass through a trocar for laparoscopic use. Alternatively, the body may include an outer wall and a hollow compressed internal part, to be filled with a fluid or gel after insertion into the body of a patient.

In an advantageous embodiment, the body is adjustable in size and invaginates in the fundus wall of the patient's stomach. As a result, the body stretches the fundus wall of the patient's stomach when the patient's stomach size increases, thereby creating satiety in a patient who also suffers from obesity. At least two Adjustable implantable stretching devices can be provided to stretch different parts of the patient's stomach wall, to treat obesity accordingly by effectively affecting the patient's appetite. The two stretching devices are suitably regulated from outside the body of a patient, whereby a first of the stretching devices is adjusted at a first time to stretch a first part of the patient's stomach wall and a second part of the patient's stomach wall. the stretching devices are adjusted a second time to stretch a second part of the patient's stomach wall.

The stretching device can be hydraulically regulated. In this case, a subcutaneously implantable hydraulic reservoir connected to the regulated hydraulic stretch device can be provided, whereby the regulated hydraulic stretch of the device is non-invasively regulated by manually pressing the hydraulic reservoir. Additionally, the movement restriction device suitably includes an inflatable body, and a pump and a chamber in fluid contact with the body are provided, wherein the pump regulates the hydraulic reservoir by pumping the fluid or air from the body to the body. camera .

The apparatus may include a device for Implantable stimulation that sends stimulation pulses to the cardia muscle to stimulate the cardia muscle and thus additionally the cardia to prevent further reflux disease. The stimulation device comprises at least one conductor and at least one electrode that receives stimulation pulses and applies to the muscle of the cardia to stimulate the cardia muscle. The at least one electrode can also be left in place by the stomach-esophageal sutures or invagination in the stomach wall. The stimulus pulses can be sent as a train of pulses, where the train of pulses repeats with a time of rest between them, the rest time that extends the rest between each pulse in the train of pulses. The stimulation device may include an electronic circuit and a power source preferably adapted to incorporate the electronic circuit and power source.

A sensor that detects a contraction wave of the esophagus, or any other parameter correlated to food intake, sends the information to the internal control unit and the internal control unit then ceases the stimulus in response to such sensor information.

The stimulation device can be controlled, at any time, by the patient.

Stimulation device The stimulation device of the apparatus will now be described.

The control device is operable by the patient to control the stimulation device to alternate continuously between an operation mode, wherein the cardiac sphincter is stimulated with pulses of energy, and a rest mode, wherein the cardiac sphincter is not stimulated . (The term patient includes an animal or a human being). The continuous alternation between rest and operation modes provides the advantage that the cardiac sphincter is able to recover during rest modes and therefore be more sensitive during modes of operation. Another advantage is that the energy consumption of the new apparatus will be quite lower compared to the previous continuous stimulation system. In addition, since the control device is operable by the patient he or she can select when the apparatus must be in the operation. For example, for some patients it may be sufficient to temporarily keep the appliance on when the patient feels reflux problems, such as at night when the patient is in bed, the others would need to have the appliance on all the time, except when the patient eats .

According to a preferred embodiment of the invention, the apparatus comprises a power source, wherein the control device controls the energy source to release the energy for use in relation to the energy of the stimulation device, when the stimulation device. As a result, the apparatus of the invention provides simple and effective control of the energy delivered to implanted components of the apparatus, which ensures extended and reliable functionality of the apparatus, possibly for the rest of the patient's life and for at least many years.

In the preferred embodiment, the control device can be controllable from outside the body of a patient to control the stimulation device to vary the intensity of the cardiac sphincter stimulus over time. More specifically, the control device can be adapted to control the stimulation device to change the intensity of the cardiac sphincter stimulus so that the sphincter tone is changed. cardias Preferably, the power source comprises an electrical power source and the control device is adapted to control the electrical source of energy to deliver electrical pulses to the stimulation device. An implantable switch for switching the management of electrical pulses from the electrical power source can be provided. The switch may be manually operable by the patient, or, alternatively, the control device may comprise a wireless remote control operable by the patient to control the switch.

Where the stimulation device stimulates the cardiac sphincter with electrical pulses there may be a problem of providing a fairly powerful voltage intensity to achieve the desired electrical stimulation of the cardia sphincter. This is so because the intensity of the electrical stimulus could be attenuated over time, due to the increase in electrical resistance caused by the formation of fibrosis where electrical conductors couple the cardiac sphincter. This problem is solved by a main embodiment of the present invention, wherein the stimulation device comprises electrical conductors for coupling the cardia sphincter, the electric power source is adapted to provide a current through the electrical conductors, and the control device is adapted to control the electric power source to release electric power such that the current intensity through the electric conductors rises to a predetermined value. As a result, the decrease in the current intensity caused by the formation of fibrosis where the conductors couple the cardia sphincter can be compensated. In this way, if the current through the conductors decreases the control device automatically controls the electric power source to release more electrical energy to restore the current intensity desired.

Advantageously, the control device is adapted to control the electric power source to release the energy in the form of an alternating current. The inventor has discovered that unlike an alternating current a direct current could cause electrolysis in the cardiac sphincter. Such electrolysis could injure the cardia sphincter.

All of the above embodiments can be combined with at least one implantable sensor to detect at least one physical parameter of the patient, wherein the control device can control the stimulation device in response to sensor signals. In particular terms, the sensor can perceive as the parameter physical contraction wave in the esophagus caused by the patient's food that swallows. In this case, the stimulation device is adapted to stop the stimulation of the cardiac sphincter in response to the sensor that detects the contraction wave in the patient's esophagus.

As an alternative, the sensor may comprise a pressure sensor for directly or indirectly detecting pressure in the esophagus. It should be understood that the expression that indirectly detects the pressure in the esophagus covers the cases where the sensor detects the pressure against the stimulation device or the human tissue of the patient.

The control device may comprise an internal control unit, preferably including a microprocessor, to be implanted in the patient to control the stimulation device. The internal control unit can suitably control the stimulation device directly in response to sensor signals. In response to sensor signals, such as pressure, the patient's position, the contraction wave in the patient's esophagus or any other important physical parameter, the internal control unit can send information about that to the outside of a patient's body. . The control unit can also automatically control the stimulation device in response to sensor signals. For example, the control unit can control the stimulation device to effectively stimulate the cardia sphincter, such that the cardia is safely completely closed in response to the sensor sensing that the patient is lying.

The control device can also, or alternatively, comprise an external control unit outside the body of a patient, wherein the internal control unit is programmable by the external control unit, for example to control the stimulation device through the weather. Alternatively, the internal control unit can control the stimulation device over time according to a program of activity program, which can be adapted to the needs of the patient.

The external control unit can also directly control the stimulation device in response to sensor signals. The external control unit can store the information about the physical parameter perceived by the sensor and can be manually operated to control the stimulation device based on the stored information. In addition, there may be at least one implantable transmitter to send the information about the physical parameter perceived by the sensor.

A great advantage is that the patient is allowed to keep the heart completely closed by means of the stimulation device using the control device whenever he wants during the day. This advantage should not be underestimated, because in the event that the patient needed to vomit it would be very difficult for him to do so if he were unable to immediately stop the stimulation of the cardia.

Conveniently, the external control unit can charge the internal control unit with data in accordance with a charging mode only approved for a doctor. For specialized controls of the stimulation device, such as electrical power, electric pulse frequency etc., the external control unit to control the internal control unit according to a doctor mode only approved for the doctor. For simple controls of the stimulation device, such as on and off, the external control unit for controlling the internal control unit according to a patient mode allowed for the patient. In this way, using the external control unit according to different modes it is possible to have certain functions of the stimulation device controlled by the patient and other more advanced functions controlled by the doctor, which allows a flexible post-operation treatment of the patient.

The control device can be adapted to control the energy source to release energy, for example intermittently releasing the energy in the form of a train of energy pulses, for direct use in relation to the energy of the stimulation device. According to a suitable embodiment, the control device controls the energy source for releasing electrical energy, and the apparatus further comprises an implantable capacitor for producing the train of energy pulses of the released energy. In this case the direct term is used to propose, on the one hand, that the released energy is used while being released by the control device, on the other hand, that the released energy can be somehow delayed, in the order of seconds, for example an energy stabilizer before being used in relation to the energy of the stimulation device.

Additionally, other additional modalities related to the supply and control of energy are described below. All these modalities can be used for all the different modalities applicable in this application, not only for the stimulation device.

According to one embodiment of the invention, the apparatus comprises implantable electrical components that include at least one, or only one, individual voltage level guard and a capacitor or accumulator, wherein Charging and discharging of the condenser or accumulator is controlled by the use of the voltage level guard.

In one embodiment, the power source is external to a patient's body and the control device controls the power source to release the wireless energy. An energy storage device, preferably an electric accumulator, can be implanted in the patient to store the wireless energy released from the external source of energy. The electric accumulator may comprise at least one capacitor or at least one rechargeable electric battery, or a combination of at least one capacitor and at least one rechargeable electric battery. Alternatively, an electrical battery can be implanted in the patient to supply the electrical energy to electrical energy consuming components implanted in the apparatus, in addition to the supply of the wireless energy. Where the control device comprises an implantable control unit the electronic circuit thereof and the stimulation device can be directly driven with the wireless power transformed, or energy of the implanted energy storage device or electric battery.

In one modality the wireless energy is directly used for the energy of the device stimulation, ie the stimulation device is driven since the wireless energy is released from the external source of energy by the control device. In this case the term is directly used to propose, on the one hand, that the stimulation device is punctually driven using the energy released first, storing it, on the other hand, that the released energy can be somewhat delayed, in the order of seconds , for, for example, an energy stabilizer before being used for the energy of the stimulation device. The wireless energy can be used to form the direct kinetic energy of the wireless field that affects the device directly or by using a power transformer device, transforming the wireless energy to the electrical energy that can be used to drive any energy consuming part of the device. directly during the transmission of wireless or indirect power after charging an accumulator. As a result, very simple control of the stimulation device is achieved and there are only implanted components of the apparatus. For example, there is no implanted power source, such as an electrical battery, nor any complicated implanted signal control system. This provides the advantage that the apparatus will be very reliable.

In one embodiment, the energy source comprises an implantable internal source of energy. In this way, when the internal source of energy is implanted in a patient, the control device controls it from outside the body of a patient to release the energy. This solution is advantageous for sophisticated embodiments of the apparatus that have a relatively high energy consumption of energy that can not be satisfied by the direct supply of the wireless energy. The internal source of energy preferably comprises an electrical source of energy, such as an accumulator or an electric battery. Alternatively, the control device can be adapted to release the wireless energy from the internal source of energy and control the stimulation device to stimulate the sphincter patient's heart with the wireless energy released. Wireless energy can comprise radiant energy or sound energy, such as ultrasound energy.

In one embodiment of the invention, the apparatus comprises a switch implanted in the patient to directly or indirectly switch the energy of the stimulation device and an internal electrical power source, such as an electric battery, implanted in the patient to supply the electrical energy for the energy of the stimulation device, where the switch directly or indirectly affects the supply of electrical energy of the internal electric power source. This solution is advantageous for embodiments of the apparatus that have a relatively high energy consumption that can not be met by the direct supply of the wireless energy.

In one embodiment of the invention, the switch is switched between a shutdown mode, where the internal electrical power source is not in use, and an ignition mode, wherein the internal electrical power source supplies electrical power for the energy of the stimulation device. In this case, the switch is conveniently operated by the wireless energy released from the external power source to switch between the on and off modes. The control device, which preferably comprises a wireless remote control, for controlling the external source of energy to release the wireless energy. The advantage of this mode is that the life of the implanted power source, such as an electric battery, can be considerably extended, since the implanted power source does not supply the power when the switch is in its shutdown mode.

In one embodiment, the control device comprises a wireless remote control for controlling the internal electrical power source. In this case, the switch is operable by the wireless energy of the External power source switching between a shutdown mode, where the internal power source of power and remote control is not in use, and a standby mode, where the remote control is allowed to control the internal power source of power for supply the electrical energy for the stimulation device energy.

In one embodiment, the apparatus further comprises a power transformer device to be implanted in the patient to transform the wireless energy into the storable energy, and an implantable energy storage device for storing the storable energy, wherein the switch is operable by the energy of the energy storage device implanted to switch between a shutdown mode, where the internal electrical power source is not in use, and an ignition mode, wherein the internal electrical power source of power supplies for the energy of the stimulation device. In this case, the control device comprises approximately a wireless remote control for controlling the energy storage device for operating the switch.

An external data communicator can be provided outside the body of a patient and an internal data communicator to be implanted in the patient can be provided for communication with the patient. external data communicator. The internal data communicator can feed data related to the patient, or related to the stimulation device, back to the external data communicator. Alternatively or in combination, the external data communicator can feed data to the internal data communicator. The internal data communicator can adequately feed data related to at least one physical signal from the patient.

Suitably, an implantable stabilizer, such as a capacitor, a rechargeable accumulator or the like, can be provided for the stabilization of the electrical energy released by the control device. In addition, the control device to control the energy source to release the energy during a certain period of time or in a certain amount of energy pulses.

All the above modalities are preferably remote controlled. In this way, the control device advantageously comprises a wireless remote control that transmits at least one wireless control signal to control the stimulation device. With such remote control it will be possible to adapt the function of the apparatus to the need of the patient on a daily basis, which is beneficial with respect to the treatment of the patient. patient.

The wireless remote control may be able to obtain information about the condition of the stimulation device and to control the stimulation device in response to the information. Also, the remote control may be able to send the information related to the stimulation device from inside a patient's body to the outside thereof.

In a particular embodiment of the invention, the wireless remote control comprises at least one external signal transmitter or transceiver and at least one internal signal receiver or transceiver implantable in the patient. In another particular embodiment of the invention, the wireless remote control comprises at least one external signal receiver or transceiver and at least one internal signal transmitter or transceiver implantable in the patient.

The remote control can transmit a carrier signal to carry the control signal, wherein the carrier signal is the frequency, amplitude or frequency and modulated amplitude and is digital, analog or digital and analogue. Also the control signal used with the carrier signal may be the frequency, the amplitude or the frequency and modulated amplitude.

The control signal may comprise a wave signal, for example, a sound wave signal, such as an ultrasound wave signal, an electromagnetic wave signal, such as an infrared light signal, a visible light signal, a light ultraviolet signal , a laser signal, a microwave signal, a radio wave signal, an x-ray radiation signal, or a gamma-ray signal. Where applicable, two or more of the above signals may be combined.

The control signal may be digital or analogous, and may comprise a magnetic or electric field. Suitably, the wireless remote control can transmit an electromagnetic carrier wave signal to carry the digital or analog control signal. For example, the use of an analog carrier wave signal carrying a digital control signal will provide secure communication. The control signal can be transmitted in pulses by the wireless remote control.

The control device can be activated in a manual or non-manual manner to control the energy source to release the energy.

In the embodiments presented in the foregoing of the invention the released energy may comprise electric power and an implantable capacitor having a capacity of less than 0.1 pF may be provided for produce the train previously of energy pulses.

Generally speaking, wireless energy comprises a signal.

The apparatus may further comprise an implantable energy transmuting device for transforming the wireless energy, for example in the form of sound waves, directly or indirectly into electrical energy, for the energy of the stimulation device. More specifically, the energy transforming device may comprise a capacitor adapted to produce electrical pulses of the transformed electrical energy.

Generally speaking, the stimulation device is advantageously embedded in a soft or gel-like material, such as a silicone material having a hardness of less than 20 Shore.

The stimulation device may comprise a band for application around the cardia, wherein the band has electrical leads to contact the cardia sphincter. The electrical conductors may comprise hooks to secure the conductors in the cardia.

The present invention also provides a system for treating stomach acidity and reflux disease, comprising an implantable stimulation device adapted to stimulate the cardia sphincter. a patient for increasing sphincter tone, and a control device that controls the stimulation device to alternate continuously between an operation mode, wherein the cardiac sphincter is stimulated with pulses of energy, and a rest mode, wherein the Cardiac sphincter is not stimulated. The pulses of energy can comprise electrical pulses. The stimulation device may comprise electrical conductors for coupling the cardia sphincter, and an electrical power source may be adapted to provide a current through the electrical conductors to form the electrical pulses. Advantageously, the control device for controlling the electrical source of energy for releasing electric power such that the current through the electric conductors rises to a predetermined value.

All the diverse components described above can be combined in the different modalities where applicable. Also various functions described in relation to the above embodiments of the invention can be used in different applications, where applicable.

All the various ways to transfer the energy and control the energy presented in the present specification can be carried out using all of the various components and solutions described.

The present invention also provides methods for treating reflux disease and heartburn.

Accordingly, according to a first alternative method, a method is provided for treating heartburn and reflux disease, comprising the steps of: implanting a stimulation device in a patient, so that the stimulation device is coupled to the cardia, and control the stimulation device to alternate continuously between an operation mode, where the cardiac sphincter is stimulated with pulses of energy to increase the tone of the sphincter, so that the cardia closes completely, and a rest mode, where the Cardiac sphincter is not stimulated.

The first alternative method can also be performed laparoscopically. In this manner, a laparoscopic method for treating stomach acidity and reflux disease, comprising the steps of: laparoscopically implanting a stimulation device in a patient, so that the stimulation device is coupled to the cardia, and control the stimulation device to alternate continuously between one mode of operation, where The cardiac sphincter is stimulated with pulses of energy to increase the tone of the sphincter, so that the cardia closes completely, and a rest mode, where the cardiac sphincter is not stimulated.

According to a second alternative method, a method is provided for treating a patient having stomach acid and reflux disease, comprising: (a) surgically implanting in the patient an electrical stimulation device that couples the cardia. (b) supplying a source of energy external to a patient's body. (c) controlling the external source of energy from outside the body of a patient to release wireless energy. Y (d) using the wireless energy released in relation to the actuation of the stimulation device.

The second alternative method may further comprise the implementation of a power transformer device, the control of the external source of energy to release the wireless energy, and transform the wireless energy by the energy transforming device into energy different from the wireless energy for the use in relation to the energy of the stimulation device. This method can also include the implantation of a stabilizer in the patient to stabilize the energy Transformed by the energy transforming device.

A method for treating heartburn and reflux disease, comprising the steps of implanting a stimulation device in a patient for coupling the cardia sphincter, providing a control device for controlling the stimulation device to stimulate the sphincter is also provided. cardia that increases the tone of the sphincter, so that the cardia closes completely, and allow the patient to operate the control device to vary the intensity of the In one embodiment, an apparatus is provided where the stimulation of the cardiac sphincter is done with pulses of energy to increase the tone of the sphincter so that the heart is completely closed and the control device is operable by the patient in which the operation can be configured. , wherein the control device is additionally operable by the patient to configure the stimulation device in operation, wherein the operational state of the stimulation device continuously alternates between an operation mode, wherein the cardiac sphincter is stimulated with pulses of energy, and a rest mode, wherein the cardiac sphincter is not stimulated, wherein the apparatus further comprises at least one implantable sensor for detecting at least one physical parameter of the patient, wherein the device control is adapted to control the stimulation device to cease the continuous alternation between the operation mode and the rest mode and to place the stimulation device in the rest mode in response to the sensor that detects the physical parameter of the patient.

In one embodiment, an apparatus is provided where the stimulation of the cardiac sphincter is done with pulses of energy to increase the tone of the sphincter so that the heart is completely closed and the control device is operable by the patient in which the operation can be configured , wherein the control device is additionally operable by the patient to configure the stimulation device in operation, wherein the operational state of the stimulation device continuously alternates between an operation mode, wherein the cardiac sphincter is stimulated with pulses of energy, and a rest mode, wherein the cardia sphincter is not stimulated, wherein the apparatus further comprises at least one implantable sensor to detect as a physical parameter of the patient at least the contraction wave in the esophagus caused by food of the patient who swallows, where the control device is adapted to control the device stimulation to stop the continuous alternation between the mode of operation and the rest mode and put the stimulation device in the rest mode in response to the sensor that detects the contraction wave in the patient's esophagus.

Surface structure The surface structure of various implants of the invention will now be described.

The present invention relates to an implant, adapted to be post-functionally adjustable and comprising at least one expandable section, wherein the implant is adapted to be adjustable between a first collapsed state and a second expanded state. In the first collapsed state the expandable section collapses, and in the second expanded state, the expandable section expands. The outer surface of the expandable section actually comprises at least in part a surface structure having raised areas alternating with the low areas. The expandable section is adapted to have, in at least one of the first collapsed state and second expanded state, a first distance between adjacent raised areas sufficiently extended to prevent the growth of fibrotic tissue directly interconnect adjacent elevated areas to a degree that compromises the capacity of adjustment between a first collapsed state and a second expanded state of the implant. The expandable section that additionally comprises connecting areas between areas adjacent highs and lows, further adapted to have, in at least one of the first collapsed state and second expanded state, a second distance between adjacent connecting areas sufficiently extended to prevent the growth of the fibrotic tissue interconnecting directly to the connecting areas adjacent to a degree that compromises the ability of adjustment between a first collapsed state and a second expanded state of the implant.

According to one embodiment, the expandable section is hollow or comprises a hollow body.

According to another embodiment, the implant is substantially completely hollow or comprises a hollow body that extends along substantially the entire length and / or the entire volume of the implant.

The fibrotic tissue can often have an expansion or thickness of about 0.5 mm to about 1.5 mm and therefore the distances between relevant surfaces of the elements of the surface structure are suitably greater than about 3 mm, therefore larger than approximately 2 x 1.5 mm. But depending on the circumstances, distances greater than about 1.0 mm to about 3 mm may also be sufficient. In cases where fibrotic tissue can be expected to having an expansion or thickness greater than about 1.5 mm the distances between relevant surfaces of the elements of the surface structure are adapted in a suitable manner.

The surface structure may comprise raised and diminished areas and it may be suitable that also a distance between the different planes of the raised and low areas be greater than a certain threshold to facilitate the collapsible and / or expandable functionality of the implant. If the distance is too small, the collapsible and / or expandable functionality of the implant may be limited. A suitable range for distance is approximately 0.5 to 10 mm, more suitable approximately 2-8 mm and approximately 3-7 mm more suitable. The surface structure may comprise different geometrical elements or shapes and any combination of such elements or forms as long as the conditions s _ above for the distances can be fulfilled. The surface structure can comprise, for example, edges and grooves of different shapes. The edges and grooves may each have a cross section which is for example wedge-shaped, polygonal, in the form of a square, in the form of a pyramid and in the form of a truncated pyramid. In addition, the edges and grooves may have cross sections of different shapes. The surface structure can also generally comprise a structure in the form of a bellows or a surface structure where the geometrical objectives of the same or different class (s) are placed on a surface. The geometrical objectives can be practically randomly placed on the surface or according to some reaction scheme.

One type of implant where this type of surface structure may be suitable are implants where the implant should have the capacity to change shape and / or size substantially. Therefore, this is a case where the presence of the fibrotic tissue could substantially impede or prevent the function of the implant. But the surface structure can be used by any implant where the characteristics of the surface structure would be advantageous for the implant.

Combination with obesity treatment Various modalities may be described below, may be combined with various methods to treat obesity. Particularly two embodiments, one comprising a stretching device and one comprising a volume filling device.

Stretching device to treat obesity It should be noted that any modality or part of the modalities or methods can be used where applicable for all the different modalities in this application.

In addition, in various embodiments, the apparatus for treating reflux may be combined with a device for the treatment of obesity that is based on the embodiment that by creating a stretching effect of the stomach wall a feeling of satiety is formed. By providing an apparatus with a stretching portion of the stomach wall stretching device, a simpler, safer, and long-term active apparatus is provided.

The expression "triggered" should be understood as activated with everything without the manual force, preferably electric power. In other words, the adjustment device is operated in a non-manual manner. It should be understood that the term "non-manual" means that the adjustment device is not operated by manually touching the subcutaneously implanted components of the apparatus or not manipulating it by touching the patient's skin. Thus, unlike prior practice in treating anal incontinence, the adjustment device of the invention is not operated by manual forces, such as by manually compressing a balloon containing fluid implanted in the scrotum or lip region. greater. Of course, manual manipulation of an implanted reservoir or other mechanical or hydraulic solutions can also be used as well as manual manipulation of a subcutaneous start or the like to activate the device.

Driven operation is all allowed within the scope of the present invention.

Alternatively, or preferably in combination with a driven operation device, the servomechanism means can be used, which allows for example a motor to operate with high speed and low power and with for example a gearbox to slow down and increase strength or torque. The servomechanism means may comprise hydraulic means, electrical control means, magnetic means, or mechanical means, which can be activated by manual manipulation means and / or remote control. Using a servomechanism system will save the use of force when adjusting the adjustment device, which may be important in many applications.

The term "servomechanism" encompasses the normal definition of a servomechanism, that is, an automatic device that controls large amounts of energy by means of very small amounts of energy, but can alternatively or alternatively encompass the definition of a mechanism that moves a weak force acting on a mobile element that has a short path in a powerful force acting on the other mobile element that has a short path. The servomechanism means may comprise a motor, preferably an electric motor, which may be reversible.

Alternatively, or preferably in combination with manual manipulation, an inverted servomechanism means can be used, which allows for example that a patient's hand use a higher force for eg manipulating a hydraulic reservoir to move a small amount of fluid with powerful force to control a greater movement of fluid. The inverted servomechanism means may comprise hydraulic means, electrical control means, magnetic means, or mechanical means, which can be activated by controlled manual and / or remote manipulation means. Using a reverse servo system will save the use of travel when adjusting the adjustment device, which may be important in many applications.

The term "inverted servomechanism means" encompasses the definition of a device that is controlled with a higher force and a small path, ie for example the movement of a small amount of fluid with a high power controls a larger amount of fluid in motion by means of much smaller force, but it can alternatively or alternatively encompass the definition of a mechanism that transfers a powerful force acting on a mobile element that has a short path in a small force acting on the other moving element that has a short trip. The means of servomechanism The reverse is preferably used when manual control of the device through intact skin is possible.

Generally speaking, two points on the stomach wall should move relative to each other and move away from each other to cause distention of a small part of the stomach wall, thereby causing satiety. This could be done in many different ways. One way is to expand an invaginated device in the wall of the stomach. Another way is to move two fixation points on the wall of the stomach. The of course first and second positions can be sutured or fixed to the stomach wall in many possible ways and the invention covers all the possibilities of relaxing the stomach wall by moving two portions of the stomach wall together and thus a first fixation of the device moving relative to a second fixation, at least two positions in the wall of the stomach. However, the soft suspended connection with the stomach wall achieved by invagating at least an adapted part of the device is preferred, wherein the fibrotic stomach to support the tissue helps to provide a long-term stable position.

Any kind of mechanical design can be used. Any mechanically or hydraulically activated mechanical construction or any other pneumatic construction. Any motor or any pump or moving material shape that changes when driven can be used to achieve the simple objective of stretching a part of the stomach wall by moving at least two portions of the stomach wall away from each other.

Any kind of hydraulic operation can be used. It will be appreciated that instead of the hydraulic operation, pneumatic operation may be used, wherein the air instead of the hydraulic fluid moves between a reservoir and a chamber formed by the stretching device. Preferably the reservoir has a closing position to maintain it in the desired position if it is handled by the patient. To compress the tank preferably, it remains compressed and releases after pressing again.

Any kind of hydraulic solution can be used for the stretching device. The hydraulic solution can be operated either mechanically or driven with any engine or stepped repeatedly as well as manually.

Of course, expanding only an invaginated part of the stomach also stretches the stomach wall which can also be achieved both mechanically, hydraulically, pneumatically and both are driven with a motor or pump or by manual force.

Volume filler device to treat obesity In addition to the various embodiments, the apparatus for treating reflux may be adapted to further treat obesity which is based on the volume filling capacity of the distal portion of the elongated motion restricting device in the stomach which forms the satiety. In the present context, when the volume filling device and its characteristics, functionality and adaptations are raised, it refers to the distant part of the elongated movement restriction device. It should be noted that, any feature, modality, mode part or method described in this document can be used where applicable for both the distant or proximal part of the motion restriction device.

The modality which follows is based on realizing that by invagating a volume filling device (here represented by the distal part of the movement restriction device) by the wall of the patient's stomach, this inflatable objective is protected from stomach acids and will continue to function for a very long time.

According to one embodiment of the invention, an apparatus for treating obesity and reflux of a patient having a stomach with a cavity is provided. food, the apparatus comprising at least one volume filling device adapted to be at least substantially invaginated by a portion of the patient's stomach wall, wherein the volume filling device is adapted to be positioned outside the patient's wall. stomach, so that the volume of the food cavity is reduced in size by a volume that substantially exceeds the volume of the volume filling device, wherein the surface of the volume filling device comprises a biocompatible material, wherein a considerable portion of the The surface of the volume filler device is adapted to rest against the outside of the stomach wall, and where the volume filler device has a maximum circumference of at least 30 mm.

By invagating the volume filling device by a portion of the patient's stomach wall outside the stomach wall, the volume filling device is protected from stomach acids, thereby providing a device that will last for a long time.

The volume filling device is adapted to be placed with the external surface of the volume filling device that rests against the wall of the stomach, such that the volume of the food cavity is reduces in size by a volume that substantially exceeds the volume of the volume filler device. The volume filling device has a maximum circumference of at least 30 millimeters. Accordingly, the apparatus of the present invention is quite suitable for treating the obesity of an obese patient, as well as the reflux disease of the same patient. This is advantageous, because reflux disease is a very common condition among humans suffering from obesity.

According to a first option, the volume filling device is adapted to be placed inside the stomach with the external surface of the volume filling device that rests against the inside of the stomach wall.

According to a second option, the volume filling device is adapted to be placed outside the stomach with the external surface of the volume filling device that rests against the outside of the stomach wall.

Preferably, the volume filling device is adapted to be completely invaginated by the wall of the patient's stomach and placed inside or outside the stomach wall through a gastroscopic instrument. For this purpose, the filling device of The volume may comprise a joining device adapted to cooperate with a gripping instrument. Suitably, the volume filler device is adapted to be non-invasively post-functionally adjustable.

The apparatus may comprise a fixation device, suitably two or more fixation devices, adapted to be involved in attaching the volume filling device to the stomach wall. The volume filling device may comprise a holding device adapted to be maintained by an instrument, suitably two or more maintenance devices, to simplify the implantation of the device.

At least a part of the volume filling device can be made of a material that is not destructible by stomach acid. The volume filling device can be destructible by acids, for example hydrochloric acid.

In one embodiment, the volume filling device is inflatable to an expanded state and comprises an enclosing wall defining a chamber, wherein the volume filling device is inflated with a gel or fluid supplied in the chamber. At least one tube can be connected to the volume filling device to supply the gel or fluid to the chamber. An injection orifice connectable with the tube can be provided.

Alternatively, the volume filling member may be provided with an inlet port for a fluid or a gel connectable to a gastroscopic instrument, wherein the inlet port comprises a fluid connection adapted to interconnect the inflatable device and the gastroscopic instrument.

The volume filler device may include a homogeneous material, such as the gel having a Shore value less than 15. The device may also be a solid body.

The volume filling device may comprise a rigid, elastic or flexible external surface. Where the outer surface is rigid, it is quite rigid where it remains undeformed when subjected to forces formed by movements of the stomach. The volume filling device may comprise a flexible non-elastic material.

According to a first general design of the volume filling device, the device has a maximum circumference as observed in a plane perpendicular to an axis through the device. The circumferences of the device as observed in other planes perpendicular to the axis are equal to the maximum circumference or decrease as observed along the axis in the direction of the maximum circumference.

For example, the device may be substantially egg-shaped, spherically shaped, or substantially shaped like an egg with a serrated intermediate section or as a folded egg.

According to a second general design of the device, the circumference of the device as observed in a plane perpendicular to an axis through the device increases and decreases at least twice as the plane moves along the axis, or decreases and increases at least once as the plane moves along the axis. For example, the device can be substantially shaped like a kidney.

The volume filling device has an elongated, rounded, bent and / or curved shape.

The volume filling device has a circumference of at least 120, 150, 180 or 220 mm.

The volume filling device has a volume in the range of 0.0001 to 0.001 m3, or 0.00001 to 0.001 m3, or 0.00001 to 0.0002 m3. The volume of the volume filling device has a volume less than 0.0002 m3.

The volume filling device may comprise at least two interconnectable portions adapted to be placed inside or outside the stomach as separate portions.

The volume filling device may comprise an elastic material, a biocompatible material and / or silicone.

Suitably, the volume filler device is provided with a coating. For example, a Parylene coating, a polytetrafluoroethylene coating or a polyurethane coating. The coating can be a multilayer coating. The volume filler device may comprise an outer surface layer of polyurethane, Teflon, or PTFE, or a combination thereof.

The volume filling device may comprise a fluid adapted to be transformed into a solid or fixed state. Such fluid may be the fluid or isotonic polyurethane. The fluid can comprise large molecules, such as iodine molecules, preventing diffusion.

The volume filling device can have a maximum circumference of at least 5 millimeters, preferably at least 8 millimeters. Suitably, the volume filling device is deformable to a maximum diameter, to be insertable in a laparoscopic trocar.

Preferably, the volume filler device is adapted to be held in place by sutures or staples from stomach to stomach to invaginate the device in the wall of the stomach. Advantageously, the volume filling device has a varying circumference to better maintain itself in its invaginated place in the wall of the patient's stomach. Sutures or staples from stomach to stomach can be provided with fixation portions that show a structure adapted to be in contact with the stomach wall to promote human tissue growth to ensure long-term placement of the volume filler device attached to the stomach. stomach wall The structure may comprise a network-like structure.

In the embodiment of the invention, the apparatus also comprises a stretching device positioned outside the stomach wall and adapted to stretch a portion of the stomach wall, thereby affecting the patient's appetite. When the volume filling device is inflatable, the apparatus may comprise a fluid connection interconnecting the stretching device and the volume filling device.

In one embodiment, the apparatus comprises a stretching device comprising at least one operable stretching device implantable in an obese patient and adapted to stretch a portion of the patient's stomach wall and an operating device for operating the stretching device. when it is implanted to stretch the portion of the stomach wall such that satiety is formed.

In one embodiment, the apparatus comprises at least one operable stretching device implantable in the patient and adapted to stretch a portion of the patient's stomach wall, and an implantable control unit to automatically control the operable stretching device, when the control unit and the stretching of the device are implanted, to stretch the portion of the wall of the stomach in relation to the patient who eats such that satiety is formed.

In one embodiment, the apparatus comprises a stretching device comprising at least one operable stretching device implantable in an obese patient and adapted to stretch a portion of the patient's stomach wall, wherein the stretching device comprising a reservoir of expandable stretching and an operating device for operating the stretching device when implanted to stretch the portion of the stomach wall, wherein the at least the distal portion of the motion restriction device is inflatable and in fluid connection with the Stretch tank, wherein the operation device comprises a pump for pumping the fluid between the main tank and the stretch tank to stretch the portion of . the stomach wall such that satiety is formed. A control device can be provided for the control of the stretching device that includes the pump. The control device may comprise a wireless remote control adapted to control the stretching device on the exterior of a patient's body, or an implantable control unit for controlling the stretching device. Alternatively, the control device may comprise a subcutaneously placed switch or reservoir adapted to control the stretching device from the exterior of a patient's body. A sensor or sensitive device to be implanted in the patient's body can be provided, wherein the implantable control unit is adapted to control the stretching device of the interior of a patient's body using information from a sensor or sensing device, adapted to the direct or indirect sense of the patient's food intake.

In one embodiment, the distal portion of the movement restriction device comprises a main volume filling reservoir, a stretching device comprising at least one operable stretching device implantable in an obese patient and adapted to stretch a portion of the wall. of the patient's stomach, where the stretching device that it comprises an expandable reservoir, adapted to be invaginated in the wall of the stomach to the upper part of the stomach, greater than the inflatable main volume filling device when the patient is standing, where the volume filling device is inflatable and in fluid connection With the stretch tank, the contractions where normal of the stomach wall, food intake related to, cause the fluid to flow from the filling reservoir of the main invaginate lower volume placed in the wall of the stomach adapted to the cause stretch tank for Stretch the portion of the stomach wall such that satiety is formed. Fluid connection between the main volume filling tank and the stretch tank comprises a check valve. Fluid connection between the main volume filling tank and the stretching tank comprises a release function adapted to release the volume in the stretching tank back to the main volume filling tank. The release function may comprise return fluid connection of a substantially smaller area than fluid connection, to slowly release the fluid back to the reservoir of the volume filling device of the stretch container to release the stretch of the portion of the wall of the stomach. A control device Additional manual comprising a subcutaneously placed reservoir adapted to control the stretching device from the exterior of the body of a patient can be provided to further affect the stretching device to stretch the portion of the stomach wall.

In one embodiment, a main volume filling reservoir adapted to be inflatable can be provided, wherein the distal portion of the movement restriction device further comprises an expandable structure, adapted to expand, when the device invaginates into the stomach wall, wherein the structure comprising a bellows adapted to take into account the fibrosis surrounding the device when implanted, such that the movement of the bellows is substantially unaffected by fibrosis.

In one embodiment, the apparatus comprises a stretching device comprising at least one operable stretching device implantable in an obese patient and adapted to stretch a portion of the patient's stomach wall and wherein the stretching device comprising an expandable structure , adapted to multiply and stretch the portion of the stomach wall, when the device invaginates into the stomach wall, where the structure comprising a bellows Special adapted to take into account the fibrosis surrounding the device when it is implanted, such that the movement of the bellows is substantially unaffected by fibrosis. An operating device for operating the stretching device can be provided to stretch the portion of the stomach wall such that satiety is formed. The apparatus may comprise an implantable control unit for automatically controlling the operable stretching device, when the control unit and the stretching of the device are implanted, to stretch the portion of the stomach wall relative to the patient eating such that it forms satiety.

In one embodiment, the apparatus comprises a stretching device comprising at least one operable stretching device implantable in an obese patient and adapted to stretch a portion of the patient's stomach wall such that satiety is formed. The control device may comprise a wireless remote control adapted to control the stretching device on the exterior of a patient's body or an implantable control unit for controlling the stretching device. Alternatively, the control device may comprise a subcutaneously placed switch or reservoir adapted to control the stretching device of the exterior of the body of a patient. A sensor or sensing device adapted to be implanted in the body of the patient can be provided, wherein the implantable control unit is adapted to control the stretching device of the interior of a patient's body using the sensor information or the sensing device. , adapted to the sense, direct or indirect, the dietary intake of the patient.

In one embodiment, the apparatus is adapted to treat reflux disease. To this end, it additionally comprises an implantable motion restricting device having an elongated shape with a proximal portion and a distal portion, the proximal portion which is adapted to be at least partly invaginated by the fundus wall of the patient's stomach and having an external surface that includes a biocompatible material. A considerable portion of the outer surface of the proximal portion of the movement restricting device is adapted to abut against the wall of the stomach without injuring the stomach at a position between the diaphragm of the patient and at least a portion of the lower part of the stomach. The invaginated stomach fundus wall, such that the movement of the cardiac notch, from the patient's stomach to the diaphragm of the patient, is restricted when the proximal part of the motion restriction device invaginates, thus preventing the heart from slipping through. the opening of Patient's diaphragm in the patient's chest, to maintain support pressure against the cardiac sphincter muscle exerted on the patient's abdomen. The proximal part of the movement restriction device has a size of at least 125 mm3 and a circumference of at least 15 mm. The distant part stabilizes and maintains the proximal part and adapts to be substantially invaginated in the stomach wall.

In another embodiment, the apparatus is adapted to treat reflux disease. To this end, it additionally comprises an implantable motion restricting device having an elongated shape with a proximal portion and a distal portion and having an external surface that includes a biocompatible material. The proximal part of the movement restriction device is adapted to be supported with at least a portion of its external surface against the fundus wall of the patient's stomach, in a position between the patient's diaphragm and the fundus wall, such that restricts the movement of the cardiac notch of the patient's stomach toward the diaphragm of the patient, when the motion restriction device is implanted in the patient, to thereby prevent the heart from sliding through the patient's diaphragm aperture in the patient's chest , to maintain the pressure of support against the sphincter muscle Cardias exerted from the abdomen of the patient, wherein the proximal part of the movement restriction device having a size of at least 125 mm3 and a circumference of at least 15 mm. A fastening device adapted to secure the proximal portion of the movement restriction device in its position, when the motion restriction device is implanted. The distant part stabilizes and maintains the proximal part and adapts to be substantially invaginated in the stomach wall In another embodiment, the apparatus is adapted to treat reflux disease. To this end, it further comprises an implantable motion restricting device having an elongated shape with a proximal portion and a distal portion and having an external surface that includes a biocompatible material, the proximal portion that is adapted to be at least part invaginated by the fundus wall of the patient's stomach. A considerable portion of the outer surface of the proximal portion of the movement restricting device is adapted to abut against the stomach wall without injuring the stomach at a position between the diaphragm of the patient and at least a portion of the lower part of the stomach. wall of the fundus of the stomach invaginated, such that the movement of the cardiac notch of the patient's stomach towards the diaphragm of the patient is restricted, when the The motion restriction device is invaginated, to prevent the heart from slipping through the patient's diaphragm opening into the patient's chest, to maintain support pressure against the cardiac sphincter muscle exerted from the patient's abdomen, the movement restriction having a size of at least 125 mm3 and a circumference of at least 15 mm, further comprising a stretching device comprising at least one operable stretching device implantable in the obese patient and adapted to stretch a portion of the stomach wall of the patient such that satiety is formed. The distant part stabilizes and maintains the proximal part and adapts to be substantially invaginated in the stomach wall.

In another embodiment, the apparatus is adapted to treat reflux disease. To this end, it additionally comprises an implantable motion restricting device having an elongated shape with a proximal portion and a distal portion and having an external surface that includes a biocompatible material. The proximal part of the movement restriction device is adapted to be supported with at least a portion of its external surface against the fundus wall of the patient's stomach, in a position between the patient's diaphragm and the wall of the fundus, such that restricts the movement of . the cardiac notch of the patient's stomach towards the diaphragm of the patient, when the motion restriction device is implanted in the patient, to prevent the heart from sliding through the opening of the patient's diaphragm into the patient's chest, to maintain the support pressure against the cardiac sphincter muscle exerted on the patient's abdomen, where the motion restriction device having a size of at least 125 mm3 and a circumference of at least 15 mm, and a fixation device adapted for securing the movement restriction device in its position, when the motion restriction device is implanted. The distant part stabilizes and maintains the proximal part and adapts to be substantially invaginated in the stomach wall. The apparatus further comprises a stretching device comprising at least one operable stretching device implantable in the obese patient and adapted to stretch a portion of the patient's stomach wall such that satiety is formed.

In one embodiment, the apparatus further comprises a stretching device comprising three or more mechanical parts coupled with different parts of the stomach wall, one part each, wherein the coupling includes suturing or stapling to the stomach wall or invaginate the mechanical parts in the part of the stomach wall with sutures from stomach to stomach, wherein the three or more mechanical parts are adapted to move relative to each other adapted to stretch three different portions of the wall, the stretching device additionally adapted has portions of the wall s drawn indistinctly from each other regardless of the force used to stretch the portion of the stomach wall as well as stretching time periods and when the stretch is applied.

In one embodiment, the apparatus further comprises a stretching device comprising two or more hydraulic parts coupled with different parts of the stomach wall, one part each, wherein the coupling includes suturing or stapling the hydraulic part to the wall of the stomach. stomach or invaginate the hydraulic parts in the part of the stomach wall, with sutures from stomach to stomach, where the two or more hydraulic parts are adapted to move relative to each other adapted to stretch three different portions of the wall, the device further adapted stretch has portions of the wall s drawn indistinctly from each other both with reference to the force used to stretch the portion of the stomach wall as well as stretch periods and when applies the stretch.

In one embodiment, the apparatus further comprises a stretching device that engages a portion of the wall of the stomach, which includes suturing or stapling the stretching device to the wall of the stomach or invagining the stretching device at the wall part. of the stomach, with sutures from stomach to stomach, wherein the stretching device is further adapted to stretch a portion of the stomach wall by controlling the force used to stretch the portion of the stomach wall as well as, periods of time are applied. the stretch and when the stretch is applied.

In one embodiment, the apparatus further comprises a stretching device comprising two parts coupled with different parts of the stomach wall, one part each, wherein the coupling includes suturing or stapling the parts to the stomach wall or invaginating the parts in the part of the wall of the stomach, with sutures from stomach to stomach, wherein the stretching device additionally adapted to stretch different portions of the wall which indistinctly between each other control the force used to stretch the portion of the stomach wall thus as also, periods of stretch time and when stretching is applied.

In one embodiment, the apparatus further comprises an external control unit for controlling the distal portion of the movement restriction device outside of a patient's body. The external control unit may comprise a wireless remote control adapted to control the device from the exterior of a patient's body. Alternatively, the external control unit may comprise a subcutaneously placed switch or reservoir adapted to control the device from the exterior of a patient's body.

In one embodiment, the apparatus further comprises a sensor or sensing device adapted to be implanted in the patient's body, wherein the implantable control unit is adapted to control the device within the body of a patient using information from a sensor or the sensing device, adapted to the sense, direct or indirect, the patient's food intake.

According to another aspect of the present invention, an apparatus for treating a reflux disease and obesity of an obese patient having a stomach with a food cavity is provided, the apparatus comprises an implantable restriction device having a part next and a distant part, wherein the distant part is adapted to be at least substantially invaginated by a portion of the stomach wall of the patient and having an external surface that includes a biocompatible material, wherein the distal portion of the movement restriction device is adapted to be placed within the stomach with the external surface of the volume filling device supporting against the interior of the stomach wall, such that the volume of the food cavity is reduced in size by a volume that substantially exceeds the volume of the volume filling device. The distal part of the movement restriction device has a maximum circumference of at least 30 millimeters.

In one embodiment of the apparatus, at least one of the segments of the movement restriction device has at least one flat surface. Preferably, at least one of the segments of the movement restriction device has the shape of a polyhedron, preferably one of the following shapes that follow tetrahedron, hexahedron, octahedron, dodecahedron and icosahedron.

In one embodiment of the apparatus, a friction enhancing material is provided. This increases the friction between segments of the adjacent movement restriction device, thereby stabilizing the motion restriction device. This friction enhancing material is preferably a glue or an adhesive.

Alternatively, at least one of the segments of the movement restriction device has a surface with a rough texture.

In one embodiment of the apparatus, at least one of the segments of the movement restriction device has the spherical shape. Alternatively, it has at least one flat surface.

In an alternative embodiment, the apparatus comprises a fluid to reduce friction between segments of the adjacent movement restriction device. The movement restriction device can thus more easily adapt its shape to the movements of a patient's body.

The apparatus in one embodiment comprises a friction reducing material of the outer surface of the volume having device segments. This friction reducing material can be a fluid that reduces friction between segments of the adjacent movement restriction device.

The apparatus may comprise a second segment of expandable motion restriction device for enclosing two or more first segments of the movement restriction device different from the second segment of motion restriction device, wherein the second segment of motion restriction device and the first segments of the motion restriction device with just create the motion restriction device. In an alternative, the second movement restriction device segment comprises a friction reducing material of an internal surface thereof, the friction reducing material that is in contact with the first segments of the movement restriction device, when implanted.

The second movement restriction device segment can be adapted to be filled with a fluid to allow mutual movement between the first segments of the adjacent movement restriction device so that the shape of the movement restriction device is adapted to the movements of the movement restriction device. the wall of the stomach, when the movement restriction device invaginates in a wall of the stomach. It is then preferred that at least a portion of the wall of the second movement restriction device segment be flexible or stretchable.

The fluid provided in the motion restriction device may be isotonic or hypertonic.

The segments of the movement restriction device can be adapted to be inserted into a sachet formed by the part of a wall of the patient's stomach. The segments of the movement restriction device they can be adapted to be filled, directly or indirectly, in the sachet formed by the part of a wall of the patient's stomach through a tubular instrument.

In one embodiment, the movement restriction device comprises a fluid that solidifies.

This liquid or fluid can be supplied to the sachet by means of a conduit.

In one embodiment, the plurality of segments of the movement restriction device is adapted to be interconnected to form the movement restriction device, after which the plurality of segments of the movement restriction device have been inserted into a human or artificial sachet. .

In one embodiment, the segments of the movement restriction device are adapted to be assembled to an implantable movement restriction device.

The segments of the movement restriction device are preferably adapted to form an implantable movement restriction device of a controlled size.

A method of operation may be combined in any manner using any apparatus, part of the apparatus or system or part of the system or any embodiment claimed in any part described herein.

A method or part of the method to be used in any combination and by the use of any apparatus or part of the apparatus or any feature in any combination where the following method steps are applicable, wherein the method may comprise one or more of the following operational steps of the method: introduce an instrument in the narrowing, pass through the esophagus, placing an anvil or unit for the supply of fixator members in the esophagus between the cardia and the level of the diaphragm, to engage in the fixation of the esophagus to the stomach tissue, to pass through the esophagus and further additionally down into the stomach, fill the stomach with gas to expand the stomach, suck the stomach fluid, observe in guiding vision when the instrument that comprises a camera, attach the instrument to the stomach, create and suture at least one sachet of the stomach wall, filling at least one sachet with a fluid and / or volume filling device or two or more volume filling devices, administer a plurality of devices of volume filling in the sachet formed in the stomach tissue through a tubular member, pass through the wall of the stomach with the instrument, pass through the wall of the stomach with the instrument to place a volume filling device outside the stomach wall, pass through the wall of the stomach with the instrument to place a permitting tube placement from a subcutaneous injection hole, place a subcutaneous injection hole, suture or staple the wall of the stomach from the inside of it to the esophagus, Suture or staple the wall of the stomach to the stomach wall from inside the stomach, couple the instrument with the esophagus, suturing or stapling a layer of stomach tissue to a layer of esophageal tissue, suturing or stapling two layers of stomach tissue to a layer of esophageal tissue, Suture or staple three layers of stomach tissue to a layer of esophageal tissue, suturing or stapling four layers of stomach tissue to a layer of esophageal tissue, suture or staple one or more layers of the tissue of the stomach at two or more positions in the esophageal tissue, the esophagus having a central axis of the esophagus, the esophagus having additionally an internal and external substantially cylindrical surface extending radially relative to the central axis of the esophagus and where the stomach tissue it is fixed to the esophageal tissue both at a first point along a first longitudinal axis of the esophageal surface, substantially parallel to the central axis of the esophagus and to a second point along a second longitudinal axis of the esophageal surface, substantially parallel to the central axis of the esophagus, at a distance from the first longitudinal axis of the esophageal surface, radially relative to the central axis of the esophagus, supply fixation members by means of a unit placed on the instrument, penetrate at least one layer of stomach tissue and a layer of tissue of the esophagus with fixation members, place the fixation members above the gastroesophageal junction to form a tunnel between the esophagus and stomach above the junction, place a part of the esophagus in the esophagus and a part of stomach in the stomach, placing a fixation member substantially between the stomach and part of the esophagus, Insert the instrument into the main stomach cavity through the cardia and adapt it to direct the instrument in the cranial direction to reach a position of the unit above the joint, allowing in the tunnel a substantially unrestricted contraction and release of the closing sphincter muscle of the cardia placed at the junction, when the tunnel has been formed.

A method or part of the method that is used in any combination and when using any apparatus or part of the apparatus or any feature in any combination where the steps of the method that follow are applicable, wherein the method one or more of the following steps of the method operational: cut the skin of a patient create a hole in. the abdominal wall of the patient introduce the instrument into the abdominal cavity opening through in the abdominal wall, attach the instrument to the stomach, remove the stomach wall to form at least one pre-shaped sachet of the stomach wall, hold the stomach wall to form at least one pre-shaped sachet of the stomach wall, suture or staple at least one bag in the stomach wall, filling at least one sachet with a fluid and / or volume filling device or two or more volume filling devices, administering a plurality of volume filling devices in the sachet formed in the stomach tissue through a tubular member, pass through the stomach wall in the stomach with instrument, pass through the wall of the stomach with the instrument to place a volume filling device inside the stomach wall, pass through the wall of the stomach with the instrument to suture the wall of the stomach to the wall of the esophagus, place a volume filler device outside the stomach wall, invaginate the volume filler device in the wall of the stomach place a subcutaneous injection hole, suture or staple the wall of the stomach to the stomach wall from the outside of the stomach, suturing or stapling the wall of the stomach to the stomach wall from the outside of the stomach without penetrating the mucosa, Suture or staple two layers of stomach wall to one or two layers of stomach wall, couple the instrument with the esophagus, hold both sides of the esophagus to attach an esophageal wall layer to the stomach tissue, hold both sides of the esophagus and the fundus wall of the stomach to attach an esophageal wall layer to one or two layers of stomach tissue, introducing a tube or a gastroscopic instrument into the esophagus comprising an anvil member or a fixation delivery member that involves fixing the esophagus to the stomach, coordinating the position of the anvil member 'or a fixation supply member within the esophagus to hold the instrument around the esophagus, suturing or stapling a layer of stomach tissue to a layer of esophageal tissue, suturing or stapling two layers of stomach tissue to a layer of esophageal tissue, Suture or staple three layers of stomach tissue to a layer of esophageal tissue, suturing or stapling four layers of stomach tissue to a layer of esophageal tissue, staple using staples of different stapling depths in different positions in a row of staples, staple from stomach to esophagus with a first depth of staple and staple from stomach to stomach with a second depth of staple smaller, stapling a sachet with sutures from stomach to stomach in a row of staples, which further comprises stapling the esophagus with staples of a greater depth included as a part of the staple row, suturing or stapling one or more layers of the stomach tissue to two or more positions in the esophageal tissue, the esophagus having a central axis of the esophagus, the esophagus having additionally an internal and external substantially cylindrical surface extending radially relative to the central axis of the esophagus and where the stomach tissue is fixed to the esophageal tissue both at a first point along a first longitudinal axis of the esophageal surface, substantially parallel to the central axis of the esophagus and to a second point along a second longitudinal axis of the surface of the esophagus, substantially parallel to the central axis of the esophagus, at a distance from the first longitudinal axis of the esophageal surface, radially relative to the central axis of the esophagus, supply fixation members by means of a unit placed on the instrument, penetrate at least one layer of stomach tissue and a layer of tissue of the esophagus with fixation members, place the fixation members above the gastroesophageal junction to form a tunnel between the esophagus and stomach above the junction, allow in the tunnel a substantially unrestricted contraction and release of the closing sphincter muscle of the cardia placed at the junction, when the tunnel has been formed, place a part of the esophagus in the esophagus and a part of stomach in the stomach through an introduction into the stomach cavity, placing a fixation member substantially between the stomach and part of the esophagus, inserting the instrument into the main stomach cavity below the union and adapted to direct the instrument in the cranial direction to reach an assembly position above the joint, operating a joint comprised in the instrument, to allow the instrument to be inserted into the main stomach cavity by bending the joint in one direction to reach a position of the part of the unit in the esophagus above the joint.

A method or part of the method used in any combination and when using any apparatus or part of the apparatus or any feature in any combination where the following method steps are applicable, wherein the method comprises operational method steps one or more of the following steps of the laparoscopic operational method: cut the skin of a patient introduce a tube through the abdominal wall, fill with a fluid or gas the abdominal cavity, introduce two or more trocars in the abdominal cavity, introduce a camera in the abdominal cavity through one of the trocars, introduce the instrument into the abdominal cavity through a trocar, attach the instrument to the stomach, remove the stomach wall to form at least one pre-shaped sachet of the stomach wall, hold the stomach wall to form at least one pre-shaped sachet of the stomach wall, suture or staple at least one pouch on the wall of the stomach, filling at least one sachet with a fluid and / or a volume filling device or two or more volume filling devices, administering a plurality of volume filling devices in the sachet formed in the stomach tissue through a tubular member, pass through the stomach wall in the stomach with instrument, pass through the wall of the stomach with the instrument to place a volume filling device inside the stomach wall, pass through the wall of the stomach with the instrument to suture the wall of the stomach to the wall of the esophagus, place a volume filler device outside the stomach wall, invaginate the volume filler device in the wall of the stomach place a subcutaneous injection hole, suture or staple the wall of the stomach to the stomach wall from the outside of the stomach, Suture or staple two layers of stomach wall to one or two layers of stomach wall, suturing or stapling the wall of the stomach to the stomach wall from the outside of the stomach without penetrating the mucosa, couple the instrument with the esophagus, hold both sides of the esophagus to fix a esophageal wall layer to the stomach tissue, hold both sides of the esophagus and the fundus wall of the stomach to attach a layer of esophageal wall to one or two layers of stomach tissue, introducing a tube or a gastroscopic instrument into the esophagus comprising an anvil member or a fixation delivery member that involves in the attachment of the esophagus to the stomach, coordinating the position of the anvil member or a fixation supply member within the esophagus to hold the instrument around the esophagus, suturing or stapling a layer of stomach tissue to a layer of esophageal tissue, suturing or stapling two layers of stomach tissue to a layer of esophageal tissue, Suture or staple three layers of stomach tissue to a layer of esophageal tissue, suturing or stapling four layers of stomach tissue to a layer of esophageal tissue, stapling using staples of different stapling depths in different positions in a row of staples, staple from stomach to esophagus with a first depth of staple and staple from stomach to stomach with a second depth of staple smaller, Staple a pouch with sutures from stomach to stomach in a row of staples, which further comprises stapling the esophagus with staples of a greater depth included as a part of the row of staples, suturing or stapling one or more layers of the stomach tissue to two or more positions in the esophageal tissue, the esophagus having a central axis of the esophagus, the esophagus having additionally an internal and external substantially cylindrical surface extending radially relative to the central axis of the esophagus and where the stomach tissue is fixed to the esophageal tissue both at a first point along a first longitudinal axis of the esophageal surface, substantially parallel to the central axis of the esophagus and to a second point along a second longitudinal axis of the surface of the esophagus, substantially parallel to the central axis of the esophagus, at a distance from the first longitudinal axis of the esophageal surface, radially relative to the central axis of the esophagus, supply fixation members by means of a unit placed on the instrument, penetrate at least one layer of stomach tissue and a layer of tissue of the esophagus with fixation members s, place the fixing members on top of the Gastroesophageal junction to form a tunnel between the esophagus and stomach above the junction, allow in the tunnel a substantially unrestricted contraction and release of the closing sphincter muscle of the cardia placed at the junction, when the tunnel has been formed, place a part of the esophagus in the esophagus and a part of stomach in the stomach through an introduction into the stomach cavity, placing a fixation member substantially between the stomach and part of the esophagus, inserting the instrument into the main stomach cavity below the union and adapted to direct the instrument in the cranial direction to reach an assembly position above the joint, operating a joint comprised in the instrument, to allow the instrument to be inserted into the main stomach cavity by bending the joint in one direction to reach a position of the part of the unit in the esophagus above the joint.

It should be noted that any modality or part of the modality as well as any method or part of the method or any apparatus or part of the apparatus or any feature or part of characteristic or any system or part of the system or any figure or part of the Figure they could be combined in any applicable way. All the examples here should be observed as parts of the general description and therefore possible to be combined in any way in general terms.

It should be noted that any modality or part of the modality or characteristic or method or associated system or part of the system described in this document can be mixed in any combination.

Brief description of the Figures The present invention will now be described in more detail by way of non-limiting examples, and with reference to accompanying Figures 1A to 123, wherein: Figures 1A-1C are schematic views of various embodiments of an apparatus for treating Gastroesophageal Reflux Disease implanted in a human patient.

Figures 2A-2B are schematic views of various embodiments of an apparatus for treating Gastroesophageal Reflux Disease implanted in a human patient.

Figures 3A-3B are schematic views of various embodiments of an apparatus for treating Gastroesophageal Reflux Disease implanted in a human patient.

Figures 4A-4D are schematic views of modalities of an apparatus for treating Gastroesophageal Reflux Disease and obesity implanted in a human patient.

Figures 5A-5B are schematic views of one embodiment of an apparatus for treating Gastroesophageal Reflux Disease implanted in a human patient.

Figures 6A-6D and 7-9 show alternative forms of a movement restriction device for treating Gastroesophageal Reflux Disease adapted to be implanted in a human patient.

Figure 10 is a total view of a patient with a movement restriction device implanted to treat Gastroesophageal Reflux Disease.

Figures 11-27 are schematic views of various ways of operating an apparatus for treating Gastroesophageal Reflux Disease.

Figures 28-34C are schematic views of various ways of configuring the hydraulic or pneumatic energy of an apparatus of the invention for treating Gastroesophageal Reflux Disease.

Figure 35 is a flow diagram illustrating steps carried out when implanting a motion restriction device to treat Gastroesophageal Reflux Disease.

Figures 36-41 show methods to restore the location of the cardia and the. fundus in a patient suffering from Gastroesophageal Reflux Disease.

Figures 42-46 show different shapes and characteristics of a reflux treatment device comprised in an apparatus according to the invention, Figures 47a-47d show a deflated inflatable reflux treatment device comprised in an apparatus according to the invention and an instrument for positioning the reflux treatment device outside the wall of the patient's stomach.

Figures 48a-48i illustrate different stages of invagating the inflatable device of Figure 47a outside of a wall of a patient's stomach.

Figure 49a shows an embodiment where the reflux treatment apparatus is also adaptable to treat obesity and comprises a plurality of segments of the movement restriction device.

Figure 49b shows a mode where the plurality of segments of the movement restriction device is provided in a sachet formed by the part of the stomach wall without any containing the outer layer.

Figure 49c shows a modality similar to that shown in Figure 49b but where the proximal part of the combined reflux and obesity treatment apparatus it has a different composition from the distant part of the combined reflux and obesity treatment apparatus.

Figures 50-511 show a modality wherein the adaptive reflux treatment apparatus is also for treating obesity.

Figures 52a-52h illustrate different steps of invagating the inflatable device of Figure 47a into a wall of a patient's stomach.

Figures 53a-53c show an instrument for forming an invagination of the stomach wall.

Figures 54-55 show an abdominal method for treating reflux disease.

Figure 56 is a schematic block diagram illustrating an embodiment of the reflux disease apparatus of the invention, wherein the wireless energy is released from an external source of energy for use in the energy of a stimulation device.

Figure 57 is a schematic block diagram illustrating another embodiment of the invention, wherein wireless energy is released from an internal source of energy.

Figures 58 to 61 are schematic block diagrams illustrating four embodiments, respectively, of the invention, wherein a switch is implanted in the patient for direct switching or indirectly the energy of the stimulation device.

Figure 62 is a schematic block diagram illustrating conceivable combinations of implantable components to achieve various communication options.

Figure 63 illustrates the apparatus according to the invention implanted in a patient.

Figure 64 is a block diagram illustrating remote control components of an embodiment of the invention.

Figures 65-68I are views of modalities of an apparatus for treating obesity by stretching the stomach wall which can combine the reflux treatment apparatus implanted in a human patient.

Figures 69a-69k is a general description of the surface structure of any implanted device of the invention.

Figures 70a-76c are views of various embodiments of an apparatus for treating obesity that can be combined with the reflux treatment apparatus implanted in a human patient.

Figures 77-93 show various ways of operating an apparatus for treating obesity that can be combined with an apparatus for treating reflux implanted in a human patient.

. Figures 94-100c show various ways of configuring the hydraulic or pneumatic energy of an apparatus for treating obesity implanted in a human patient.

Figures 101a-105b show various instruments for treating reflux and obesity.

Figures 106-107 show methods for surgery to treat reflux and obesity.

Figure 108 shows an embodiment of the movement restriction device in segments before assembly.

Figure 109 shows an embodiment of the movement restriction device when the first part and the second part are assembled.

Figure 110 shows the modality of Figure 109 when a third and a quarter are assembled.

Figure 111 shows the modality of Figure 110 when the final part is assembled.

Figure 112 shows the modality of Figures 108-111 when it is finally assembled.

Figure 113a shows the main part of the modality of Figure 108 with the operation channels.

Figures 113b to 113f show cross-sectional views of the main part of Figure 113a according to planes I-I; II-II, III-III, IV-IV, respectively.

Figures 114 and .115 show alternative embodiments of the device as shown in Figure 108.

Figures 116a-116d illustrate the insertion of the segments of the movement restriction device shown in Figure 114 by means of an instrument.

Figures 117a-117c illustrate a preferred method to invaginate a plurality of segments of the movement restriction device in a wall of the stomach using an instrument.

Figure 118 illustrates an alternative instrument to invaginate a plurality of segments of the motion restriction device.

Figures 119a-119e illustrate different forms of motion restriction devices when a plurality of segments of the movement restriction device is used to form a motion restriction device.

Figure 120 is a sectional view of a movement restriction device comprising the fluid.

Figure 121 is a sectional view of a motion restriction device defining a plurality of segments of the motion restriction device.

Figure 122 is a view of a motion restriction device comprising a plurality of segments of the motion restriction device contained in a fluid.

Figure 123 is a sectional view of a motion restriction device defining a plurality of segments of the movement restriction device contained in a fluid.

Detailed description of the invention As used in this document, the term segment must be broadly considered to define any of the parts in which something can be divided.

Motion restriction device Figure 1A is a schematic view showing an apparatus 11, including a motion restricting device 10 of a biocompatible material, to treat reflux disease, according to the invention, implanted in a human patient. In Figure 1A, device 10 is invaginated in the fundus. The device 10 comprises a body 13 having an outer surface 15 suitable for abutting against a portion of the outer wall 16a of the fundus wall of the stomach 16 at a position between the diaphragm of the patient 18 and at least a portion of the part bottom of the wall of the fundus of the invaginated stomach 16. In this way, with the device 10 invaginated in this way, the movement of the stomach is restricted. the cardiac notch of the patient's stomach towards the diaphragm of the patient, thus the cardia is prevented from slipping through the patient's diaphragm aperture into the thorax of patient 20 and the supporting pressure against the patient's heart the sphincter muscle exerted of the patient's abdomen is maintained The body 13 is inflatable and adapted to be inflated with a gel or fluid. A fluid or gel receiving member for receiving fluid to inflate the movement restriction device may be provided. Alternatively, the body 13 includes a homogeneous material and be a solid body. Alternatively, the body 13 includes an external wall in the form of an enclosing wall defining a chamber. The outer wall can be rigid, elastic or flexible. Where the outer wall is rigid, it is quite rigid where they remain undeformed when subjected to forces formed by movements of the stomach.

The body 13 of the movement restriction device can be fixed to the wall 16a of the fundus 16 in a variety of different ways. In the embodiment shown in Figure 1A, the device 10 invaginates in the wall of the fundus of the stomach from outside the stomach.

After the invagination, a first fixation device comprising several sutures or staples from stomach to stomach 22a is applied to maintain intussusception intact in the short term. This allows the growth of the human tissue to keep the invagination intact in the long term.

There may optionally be a second fixation device comprising several sutures or staples 22b that are provided between the wall 16a of the fundus 16 and the wall 24a of the esophagus 24 to hold the device 10 in position between the diaphragm of the patient 18 and at least a portion of the lower part of the wall of the fundus of the invaginated stomach 16. In this way, the device 10 is fixed in this position by this second fixing apparatus. Direct or indirect fixation of the device 10 can be provided to the diaphragm muscle 18 or other muscle tissue. As an alternative, direct or indirect fixation of the device 10 to the esophagus can be provided. Alternatively, or in addition, there may be a third fastening device in the form of sutures or staples 22c provided between the wall 16a of the fundus 16 and the diaphragm 18 to hold the device 10 in position.

Figure IB shows a modality substantially similar to that shown in Figure 1A. In Figure IB the body 13 and the invagination are, in addition to the fixation 22, fixed by means of sutures and / or staples 22c between the reflux body 13 and the diaphragm 18, to keep the device in position above the cardia 14.

Figure 1C shows another embodiment substantially similar to that shown in Figure 1A. In Figure 1C the reflux treatment device is held in place by stitches or stomach-to-stomach clips 22a connecting the wall 16a of the fundus 16 to the wall 16a of the fundus 16. In addition the reflux treatment device 10 is maintained in place by sutures 22b or staples of the wall 16 of the fundus 16a to the wall of the esophagus 24a, and by sutures or staples of the fundus wall 16a to the diaphragm.

An alternative embodiment of an apparatus 17 for the treatment of reflux disease according to the invention is depicted in Figure 2A. This embodiment is, in many aspects, similar to one described above with reference to Figures 1A-1C. In this way, a movement restriction device 10 is shown implanted in a human patient and invaginated in the fundus. However, in the embodiment shown in Figure 2A, the device 10 invaginates from the inside of the stomach, instead of from the outside of the stomach, as in Figure 1A-1C. The movement restriction device 10 comprises a body 13 adapted to be supported against a portion of the inner wall of the fundus wall of the stomach 16 in a position between the diaphragm of the patient 18 and at least a portion of the lower part of the wall of the fundus of the invaginated stomach 16. In this embodiment, the body 13 is located above the cardiac 14 area of a human mammal or permanent animal patient. The body 13 of the device 10 is shaped to abut against the wall 16a of the fundus 16, and additionally, has an external surface 15 suitable for abutting against this wall of the fundus. In this way, with the device 10 invaginated in this way as described above in relation to Figure 1A, the movement of the cardiac notch of the patient's stomach towards the diaphragm of the patient is restricted, thus the cardia is prevented from sliding through the patient's stomach. the diaphragm opening of the patient in the thorax of patient 20 and the pressure of support against the cardiac sphincter muscle exerted from the abdomen of the patient is maintained.

After the invagination, various sutures or staples from stomach to stomach 33a comprising a first fixation device are applied from within the stomach 16 to maintain intussusception intact in the short term. This allows the growth of human tissue, keeping the invagination intact in the long term. Additional sutures or staples 22b comprising a second fixation device may be provided between a portion of the wall 16b of the fundus 16 that forms part of the invagination of the device 10 and the wall 24a of the esophagus 24 to hold the device 10 in position. Similarly, a third fixation device in the form of sutures or staples 22c may be provided between another portion of the wall 16c of the fundus 16 that forms part of the invagination of the device 10 and the diaphragm 18 to hold the device 10 in position.

An alternative embodiment is shown in Figure 2B. This embodiment is in many ways similar to that described with reference to Figure 2A. However, here the sutures and staples 22b and 33a are all connected with the fixator of the reflux treatment device 10. This method lacks sutures or staples from stomach to diaphragm.

An alternative of the apparatus 19 for the treatment of reflux disease is depicted in Figure 3A. This alternative is in many ways similar to those described above with reference to Figures 1A-1C of Figures and 2A-2B. In this way, a movement restriction device 10 is shown implanted in a human patient. The device 10 comprises a body 13 adapted to abut against a portion of the fundus wall of the stomach 16 in a position between the diaphragm of patient 18 and fundus wall of stomach 16. However, in this alternative, device 10 does not invaginate in stomach 16. Instead, the fixation of device 10 comprises a binding strre 10a, so Preferred is a network-like strre that is adapted to be in contact with the fundus wall of the stomach 16a to promote human tissue growth to ensure long-term placement of the reflux disease treatment device attached to the stomach wall. In the short term, a first fastening device in the form of sutures or staples 44a may be provided between the bonding strre 10a and the wall of the fundus 16a to maintain the bonding strre 10a in place.

The attachment strre 10a can be adapted for a second fixation device in the form of sutures or staples 44b that are provided between the wall 16a of the fundus 16 and the wall 24a of the esophagus 24 to hold the device 10 in position between the diaphragm of the patient 18 and stomach fundus wall 16. Similarly, the attachment strre 10a can also be adapted for a third fixation device in the form of sutures or staples 44c that are provided between the wall 16a of the fundus 16 and the diaphragm 18, again , to keep the device 10 in its position.

An alternative modality is shown in Figure 3B. This embodiment is in many ways similar to that described with reference to Figure 3A. In this embodiment, the reflux treatment device 10 is, as in the invaginated Figures 2A-2B of the interior of the stomach. The attachment structure 10a is placed on the wall 16a of the fundus 16 above and around the invagination formed by the reflux treatment device 10.

An alternative embodiment of an apparatus 21 for the treatment of reflux disease according to the invention is depicted in Figure 4A. This embodiment is in many ways similar to that described above with reference to Figures 1A-1C. In Figure 4A, a view of a device 10 for the treatment of reflux disease according to the invention is shown implanted in a human patient. In Figure 4A, the motion restricting device 10 is again invaginated in the fundus 16. The device 10 comprises a body 13 having an external surface 15 suitable for abutting against a portion of the outer wall 16a of the wall of the fundus of the stomach 16 in a position between the diaphragm of patient 18 and at least a portion of the lower part of the wall of the fundus of the invaginated stomach 16. The body 13 is shaped to bear against the outer wall 16a of the fundus 16. In this way , with the device 10 'invaginated in this way, the movement of the cardiac notch of the patient's stomach towards the diaphragm of the patient is restricted, thus the cardiac is prevented from sliding through the patient's diaphragm opening in the patient's thorax 20 and the support pressure against the patient's heart the sphincter muscle exerted from the patient's abdomen is maintained.

In the embodiment of Figure 4A, as in the embodiment of Figure 1A, after intussusception of device 10 in fundus 16, a first attachment device comprising several sutures or staples from stomach to stomach 22a is applied to maintain intussusception intact. short term. A second fixation device comprising several sutures or staples 22b is provided to hold the device 10 in position between the diaphragm of the patient 18 and at least a portion of the bottom part of the fundus wall of the invaginated stomach 16. In addition, a third fastening device in the form of sutures or staples 22c may be provided between the wall 16a of the fundus 16 and the diaphragm 18, again, to keep the device 10 in its position.

In the embodiment shown in Figure 4A, the size of the motion restriction device 10 can be regulated by being implanted. The device 10 is associated with a hydraulic reservoir 52 connected to the device 10 by a cable 52b, whereby a non-invasive regulation can be carried out by manually pressing the reservoir 52. The device 10 is, in turn, connected. with one or more smaller cameras 10b.

Additionally, the above modality can alternatively be used to also treat obesity. The apparatus, in this embodiment, can be adapted to treat obesity by using the volume of the movement restriction body 13 to contain a fluid, and additionally using one or more smaller chambers 10b connected to the body 13 with a pump to be filled with the body. fluid to stretch the fundus wall to create satiety. The small chambers 10b are also adapted to be invaginated in the fundus wall of the stomach, and when they are filled with the fluid, an expansion is carried out which results in the feedback of the human sensor creating satiety. By placing the small reservoir / hydraulic pump subcutaneously in the patient, the patient is able to pump the hydraulic fluid to fill the small chambers to feel complete upon request.

An alternative embodiment is shown in Figure 4B. This embodiment is substantially similar to that shown in Figure 4A, but differs in how the reflux treatment device 10 and the chambers 10b is controlled. Here, cameras 10b are not controlled by a pump subcutaneous, but with an internal control unit 56 operated. The internal control unit 56 comprises means for the patient to control the device 10 on how this should be used with reference to the treatment of reflux and / or obesity. This may also comprise means for supplying power to the device.

The internal control unit 56 may comprise an electric battery 70, an electrical switch 72, a motor / pump 44, a reservoir 52, and an injection port 1001. A power-transmission device 34 with a remote control is adapted for control and operate the device. The items that are selected according to the circumstances, for example if the device is electrically, hydraulically, pneumatically or mechanically operated.

The control unit can receive the input of any sensor 76, especially a pressure sensor. Any type of sensor can be supplied. The preferable internal control unit 56 includes intelligence in the form of an FPGA or MCU or ASIC or any other circuit, component or memory (for a more extensive description see below under the system).

Figure 4C shows Figure 4A essentially the same as with the difference that there is a small camera 10b instead of two small cameras as in Figure 4A. The Figure 4C shows the small camera .10b in its empty state while Figure 4D shows the small cameras 10b when this has been filled and expanded to create satiety.

Still an alternative embodiment of an apparatus 23 for the treatment of reflux disease according to the invention is depicted in Figure 5A. This embodiment is, again, in many aspects similar to that described above with reference to Figure 1A-1C. Thus, as in the embodiment of Figure 1A, a motion restricting device 10, which is invaginated in the fundus, comprises a body 13 having an external surface 15 suitable for abutment against a portion of the outer wall 16a of the fundus wall of the stomach 16 in a position between the diaphragm of the patient 18 and at least a portion of the bottom part of the wall of the fundus of the invaginated stomach 16. The body 13 of the device 10 is shaped to lean against the outer wall 16a of the fundus 16 and has a generally smooth external surface 15 suitable for leaning against this wall of the fundus. And, again, after the invagination of the device 10 in the fundus 16, a first fixation device comprising several sutures or staples from stomach to stomach 22a is applied to keep the invagination intact in the short term. A second device Fixation comprising several sutures or staples 22b applied between the wall 16a of the fundus 16 and the wall 24a of the esophagus 24 is provided to keep the device 10 in its position.

In the alternative embodiment shown in Figure 5A, the apparatus 23 further comprises a stimulation device 26 for sending the stimulation pulses adapted to stimulate the cardia muscle to further close the cardia to further prevent reflux disease. The apparatus 23 comprises at least one conductor 26a and at least one electrode 26b adapted to receive the stimulation pulses.

The stimulation device 26 preferably comprises an electronic circuit and an energy source, which in the preferred embodiment is provided in the device 10.

The stimulation device 26 preferably sends the stimulation pulses as a train of pulses, where the pulse train is adapted to repeat with a rest time between them, the rest time that extends the rest between each pulse in the train of pulses.

Figure 5B shows essentially the same embodiment as in Figure 5A, with the addition of an internal control unit 56, a remote control 28 and a device of external energy transmission 34. The internal control unit 56 is connected to the stimulation device with an energy cable 56b. The internal control unit 57 may comprise an electrical battery 7 and an electrical switch 72 and other components described below under the system.

The reflux disease treatment device 10 can, according to one embodiment of the present invention, be formed as a body in general egg-shaped, as shown in Figure 6A. The reflux disease treatment device 10 may, according to another embodiment of the present invention, also be formed as an egg-shaped body or sphere with an indentation at its center, as shown in Figure 6B. The reflux disease treatment device 10 may, according to yet another embodiment of the present invention, be further formed as a slightly bent egg-shaped body as shown in Figure 6C.

The reflux disease treatment device 10, according to another embodiment of the present invention, can be formed as a body in generally spherical shape, as shown in Figure 6D.

As mentioned above, the reflux treatment device 10 is fixed in a position that is greater the esophagus in a permanent patient. To enable this, a reflux treatment modality shown in Figure 7 comprises a lOd fixer that can function as, for example, a junction point for sutures or staples. The fasteners can be a loop or an edge with or without holes or have any other shape that makes it suitable for fixing the reflux treatment device 10.

Figure 8 shows an embodiment of the reflux treatment device 10 where it is adjustable by a hydraulic means, and lOe is an injection orifice where the hydraulic fluid can be in order to multiply the device. Alternatively, in one embodiment the reflux treatment device 10 can be inflated from a small size to a larger size during a surgical procedure where it is advantageous that the device is initially of small size, for example during a laparoscopic procedure. In such an embodiment, any filling, solid, fluid or gas material many injected the inlet orifice lOe for the reflux treatment device 10 to achieve its final shape.

Figure 9 shows a mode where the reflux treatment device 10 has a sunken edge 10F adapted to be maintained with a surgical tool. This should be used, for example, during a Surgical procedure when the reflux treatment device is implanted.

When the reflux disease treatment device 10 is generally spherical, whereby this can be done to fully or partially cover the esophagus, the internal diameter D of the reflux disease treatment device 10, is preferably such which may encompass the esophagus and at least a portion of the fundus so that the device does not remain at rest directly against the wall of the esophagus when implanted.

The motion restriction device 10 may incorporate any shape that allows the device 10 to rest in a position where the movement of the cardiac notch of the patient's stomach is restricted to the diaphragm of the patient, so the cardia is prevented from sliding through the patient's stomach. the diaphragm opening of the patient in the patient's chest and the support pressure against the cardiac sphincter muscle exerted on the patient's abdomen is maintained.

System An energy and operation system, generally designated 28, for incorporation into the apparatus according to the invention, will now be described with reference to Figures 10-27.

The system 28 shown in Figure 10 comprises an internal energy source in the form of an energy transforming device, implanted 30 adapted to supply energy consuming components of the reflux disease treatment apparatus with energy through an energy supply line 32. An external energy transmission device 34 includes a wireless remote control that transmits a wireless signal, which is received by a signal receiver that can be incorporated in the implanted power transformer device 30, or be separated. The implanted power transforming device 30 transforms the energy of the signal into the electrical energy that is delivered through the power supply line 32.

The system 28 of Figure 10 is shown in block diagram form more generalized in Figure 11, where the skin of the patient 36, generally shown by a vertical line, separates the inside of the patient 29 to the right of the line from the outside to the left of the line.

Figure 11 shows a simplified block diagram showing the motion restriction device 10, the energy transforming device 30 which drives the device 10 through the power supply line 32, and the external energy transmission device 34.

Figure 12 shows an embodiment of the invention identical to that of Figure 11, except that a reversing device in the form of an electrical switch 38 operable by the polarized energy is also implanted in the patient 29 for the reversal of the device 10. The wireless remote control of the external power transmission device 34 transmits a wireless signal that carries the polarized energy and the implanted power transformer device 30 transforms the polarized radio energy into a polarized current to operate the electrical switch 38. When the polarity of the the current is displaced by the implanted power transformer device 30 the electric switch 38 reverses the function carried out by the device 10.

Figure 13 shows an embodiment of the invention identical to that of Figure 11, except that an operation device 40 implanted in the patient to regulate the reflux disease treatment device 10 is provided between the implanted power transformer device 30 and the device 10. This operating device can be in the form of about 40 motor, like an electric servomotor. The motor 40 is driven with the energy of the implanted power transformer device 30, since the remote control of the device. external power transmission 34 transmits a wireless signal to the receiver of the implanted power transformer device 30.

Figure 14 shows an embodiment of the invention identical to that of Figure 11, except that it also comprises an operation device that is in the form of a unit 42 that includes a motor / pump unit 78 and a fluid reservoir 46 implanted in the patient. In this case the device 10 is hydraulically operated, i.e. hydraulic fluid is pumped by the motor / pump unit 44 of the fluid reservoir 46 through a conduit 48 to the device 10 to operate the device, and the hydraulic fluid is pumped by the motor / pump unit 44 again from the device 10 to the fluid reservoir 46 to return the device 10 to an initial position. The implanted power transforming device 30 transforms the wireless energy into a current, for example a polarized current, to drive the motor / pump unit 44 through an electric power supply line 50.

Instead of a hydraulically operated movement restriction device 10, it is also provided that the operating device comprises a pneumatic operating device. In this case, pressurized air can be used for regulation and the fluid reservoir is replaced by an air chamber and the fluid is replaced by air.

In all these embodiments the energy transforming device 30 may include a rechargeable accumulator such as an electric battery or a capacitor to be charged by the wireless energy and supplies the energy for any energy consuming part of the apparatus.

The external power transmission device 34 is preferably wireless and may include a remotely controlled control device for controlling the device 10 from outside the human body.

Such a control device may include a wireless remote control as well as a manual control of any implanted part to make contact with by patients give with the greatest indirect probability for example a button to press placed under the skin.

Figure 15 shows an embodiment of the invention comprising the external power transmission device 34 with its wireless remote control, the device 10, in this case hydraulically operated, and the implanted power transforming device 30, and additionally comprising a reservoir of hydraulic fluid 52, a motor / pump unit 44 and a device that reverses in the form of a valve changing device hydraulic 54, all implanted in the patient. Of course the hydraulic operation could be carried out easily by changing only the direction that you repeatedly step on and the hydraulic valve can therefore be omitted. The remote control can be a device separate from the external power transmission or included in it. The motor of the motor / pump unit 44 is an electric motor. In response to a control signal from the wireless remote control of the external power transmission device 34, the implanted power transformer device 30 drives the motor / pump unit 44 with the energy of the energy carried by the control signal, so which the motor / pump unit 44 distributes the hydraulic fluid between the hydraulic fluid reservoir 52. and the device 10. The remote control of the external power transmission device 34 controls the hydraulic valve changing device 54 to displace the hydraulic fluid the direction flows between an address where the fluid is pumped by the motor / pump unit 44 of the hydraulic fluid reservoir 52 to the device 10 to operate the device 10, and another direction where the fluid is pumped by the motor unit / pump 44 again from device 10 to hydraulic fluid reservoir 52 to return device 10 to an initial position .

Figure 16 shows an embodiment of the invention identical to that of Figure 15, except that an internal control unit 56 controlled by the wireless remote control of the external power transmission device 34, an accumulator 58 and a capacitor 60 is also implanted in the patient. The internal control unit 56 configures the storage of electric energy received from the implanted energy that transforms the device 30 into the accumulator 58, which supplies the power to the device 10. In response to a control signal of the wireless remote control of the transmission device of external power 34, the internal control unit 56 electrical energy releases the accumulator 58 and transforms the energy released through power lines 62 and 64, or directly transforms the electrical energy of the implanted power transformer device 30 through a line of power 66, the capacitor 60, which stabilizes the electric current, an energy line 68 and the power line 64, for the operation of the device 10.

The internal control unit is preferably programmable from outside the body of a patient. In a preferred embodiment, the internal control unit is programmed to regulate the device 10 to stretch the stomach according to a schedule of the period of pre-programmed time or input of any sensor that detects any possible physical parameter of the patient or any functional parameter of the device.

According to an alternative, the capacitor 60 in the embodiment of Figure 16 can be omitted. According to another alternative, the accumulator 58 in this mode can be omitted.

Figure 17 shows an embodiment of the invention identical to that of Figure 10, except that an electric battery 70 for supplying power for the operation of the device 10 and an electrical switch 72 for switching the operation of the device 10 is also implemented in the patient.' The electrical switch 72 is operated by the energy supplied by the implanted power transformer device 30 to the switch of a shutdown mode, where the electrical battery 70 is not in use, to an ignition mode, wherein the electrical battery 70 supplies power for the operation of the device 10.

Figure 18 shows an embodiment of the invention identical to that of Figure 16, except that an internal control unit 56 controllable by the wireless remote control of the external power transmission device 34 is also implanted in the patient. In this case, the electrical switch 72 is operated by the energy supplied by the implanted power transformer device 30 to the switch of a shutdown mode, wherein the wireless remote control is prevented from controlling the internal control unit 56 and the electrical battery is not in use, to a standby mode, in where the remote control is allowed to control the internal control unit 56 to release the electric power of the electric battery 70 for the operation of the device 10.

Figure 19 shows an embodiment of the invention identical to that of Figure 17, except that an accumulator 58 is replaced for the electric battery 70 and the implanted components are interconnected differently. In this case, the accumulator 58 stores the energy of the implanted power transformer device 30. In response to a control signal of the wireless remote control of the external power transmission device 34, the internal control unit 56 controls the electrical switch 72 for switching from off mode, where the accumulator 58 is not in use, to an ignition mode, wherein the accumulator 58 supplies the energy for the operation of the device 10.

Figure 20 shows an embodiment of the invention identical to that of Figure 18, except that an electric battery 70 is also implanted in the patient and the implanted components are interconnected differently. In In response to a control signal from the wireless remote control of the external power transmission device 34, the internal control unit 56 controls the accumulator 58 to administer power to operate the electrical switch 72 to change off mode, wherein the battery Electric 70 is not in use, to an ignition mode, wherein the electric battery 70 supplies electrical power for the operation of the device 10.

Alternatively, the electrical switch 72 can be operated by the energy supplied by the accumulator 58 to change from a shutdown mode, wherein the wireless remote control is prevented from controlling the electrical battery 70 to supply the electrical power and is not in use, to a standby mode, wherein the wireless remote control is allowed to control the electric battery 70 to supply the electrical power for the operation of the device 10.

It should be understood that the switch should be considered in its broadest form. These means an FPGA or a DA converter or any other electronic component or circuit can switch the power on and off preferably by controlling it from outside the body of a patient or by an internal control unit.

Figure 21 shows an embodiment of the invention identical to agüella of Figure 17, except that one motor 40, a mechanical reversing device in the form of a gearbox 74, and an internal control unit 56 for controlling the gearbox 74 are also implanted in the patient. The internal control unit 56 controls the gearbox 74 to reverse the function carried out by the device 10 (mechanically operated). Even simpler is to commute the motor direction electronically.

Figure 22 shows an embodiment of the invention identical to that of Figure 20 except that the implanted components are interconnected differently. Thus, in this case, the internal control unit 56 is operated by the electric battery 70 when the accumulator 58, suitably a condenser, activates the electrical switch 72 to change to an ignition mode. When the electrical switch 72 is in its ignition mode the internal control unit 56 is allowed to control the electric battery 70 to supply, or not supply, power for the operation of the device 10.

Figure 23 schematically shows conceivable combinations of implanted components of the apparatus to achieve various communication options. Basically, there is device 10, the internal control unit 56, motor or pump unit 44, and the external power transmission device 34 which includes the control External wireless remote. As already described above, the wireless remote transmits a control signal that is received by the internal control unit 56, which in turn controls various implanted components of the apparatus.

A feedback device, preferably in the form of a sensor 76, can be implanted in the patient to detect a physical parameter of the patient, such as a contraction wave in the esophagus that reports that the patient eats. The internal control unit 56, or alternatively the external wireless remote control of the external power transmission device 34, may the device 10 control response to signals from the sensor 76. A transceiver may be combined with the sensor 76 to send the information about the parameter perceived physical to the external wireless remote control. The wireless remote control may comprise a signal transmitter or transceiver and the internal control unit 56 may comprise a signal receiver or transceiver. Alternatively, the wireless remote control may comprise a signal receiver or transceiver and the internal control unit 56 may comprise a signal transmitter or transceiver. The above transceivers, transmitters and receivers can be used to send the information or data related to the device 10 from inside the patient's body to the outside thereof.

Alternatively, the sensor 76 may be configured to detect a functional parameter of the device 10.

Where the motor / pump unit 44 and electric battery 70 for driving the motor / pump unit 44 is implanted, the electric battery 70 can be equipped with a transceiver to send the information about the condition of the electric battery 70. To be more Accurate, when charging with an electric battery or accumulator with the energy feedback information related to charging that the process is sent and the power supply is changed accordingly.

Figure 24 shows an alternative embodiment where the device 10 is regulated from outside the body of a patient. The system 28 comprises a movement restriction device 10 connected to an electrical battery 70 through a subcutaneous switch 80. In this way, the regulation of the device 10 is carried out non-invasively by manually pressing the subcutaneous switch, whereby the operation of device 10 is activated and turned off. It will be appreciated that the embodiment shown is a simplification and that additional components, such as an internal control unit or any other part described in the present application can be added to the system.

Figure 25 shows an alternative modality, in wherein the system 28 comprises a motion restriction device fluid connection of 10 in fluid connection with a reservoir of hydraulic fluid 52. The non-invasive regulation is carried out by manually pressing the hydraulic reservoir connected to the device 10.

A further embodiment of a system for incorporation into the apparatus according to the invention comprises a feedback device for sending the information from inside a patient's body to the outside thereof to provide feedback information related to at least one functional parameter of the patient. device of restriction of movement or apparatus or a physical parameter of the patient, thus optimizing the performance of the device.

A preferred functional parameter of the device is correlated with the transfer of energy to charge the internal energy source.

In Figure 26, an array is schematically illustrated to deliver an exact amount of energy to a system 28 implanted in a patient, whose skin 36 is indicated by a vertical line. A motion restricting device 10 is connected to an implanted energy transforming device 30, also internally located the patient, preferably only under the skin of the patient 36. Generally speaking, the device Implanted energy transformer 30 can be placed in the abdomen, thorax, muscle fascia (for example in the abdominal wall), subcutaneously, or any other suitable location. The implanted power transformer device 30 is adapted to receive wireless energy E transmitted from an external power source 34a provided in the external energy transmission device 34 located outside the patient's skin 36 in the vicinity of the implanted power transformer device. .

As is well known in the art, the wireless energy E can be transferred in general by means of any suitable Transcutaneous Energy Transfer (TET) device, such as a device that includes a primary coil configured in the external power source 34a and a adjacent secondary coil configured in the implanted power transformer device 30. When an electric current is fed through the primary coil, the energy in the form of a voltage is induced in the secondary coil that can be used to operate a restriction device of movement, for example after storing the input energy in an energy storage device or accumulator, such as an electric battery or a capacitor. However, the present invention is not generally limited by any technique of particular energy transfer, TET devices or energy storage devices, and any kind of wireless power can be used.

The amount of internal energy received inside the body to the device can be compared to the energy used by the device. It is then understood that the term used by the device also includes the energy stored by the device. The amount of energy transferred can be regulated by means of an external control unit 34b control of the external power source 34a based on the determined energy balance, as described above. In order to transfer the correct amount of energy, the energy balance and the required amount of energy can be determined by means of an internal control unit 56 connected to the reflux disease treatment device 10. The internal control unit 56 can thus be configured to receive various measurements obtained by suitable sensors or the like, are not shown, quantifying certain characteristics of the rlO, in some way reflecting the required amount of energy necessary for the proper functioning of the device 10. Furthermore, the current state of the patient can also be detected by means of suitable measuring devices or sensors, in order to provide parameters that reflect the condition of patients Therefore, such features and / or parameters can be related to the current state of the device 10, such as power consumption, operational mode and temperature, as well as the condition of patients reflected by, for example, body temperature, blood pressure, heartbeats. of the heart and breathing.

Additionally, a power storage device or accumulator 58 may optionally be connected to the implanted power transformer device 30 for accumulation of the energy received for later use by device 10. Alternatively or in addition, the characteristics of such accumulator, also reflecting the amount required energy, can also be quantified. The accumulator can be replaced by an electric battery, and the quantized characteristics can be related to the current state of the electric battery, such as voltage, temperature, etc. In order to provide sufficient and current voltage to the device 10, and also to avoid excessive heating, it is clearly understood that the electric battery should be optimally charged by receiving a correct amount of energy from the implanted power transforming device 30, i.e., not too much. little or too much The accumulator can also be a capacitor with corresponding characteristics.

For example, the battery characteristics can be quantified regularly to determine the current state of the electrical battery, which can then be stored as state information in a suitable storage means in the internal control unit 56. In this way, whenever the new measurements are made, the information The status of stored electric battery can be updated accordingly. In this way, the status of the electric battery can be calibrated by transferring a correct amount of energy, to keep the electric battery in an optimal condition.

In this way, the internal control unit 56 is adapted to determine the energy balance and / or the currently required amount of energy, (energy per unit time or accumulated energy) based on measurements made by the aforementioned sensors or devices of measurement in the reflux disease treatment device 10, or the patient, or an energy storage device to be used, or any combination thereof. The internal control unit 56 is further connected to an internal signal transmitter 82, configured to transmit a control signal that reflects the determined required amount of energy, to an external signal receiver 34c connected to the external control unit 34b. The amount of energy transmitted from the external power source 34a can then be regulated in response to the received control signal.

Alternatively, the sensor measurements can be transmitted directly to the external control unit 34b where the energy balance and / or the currently required amount of the energy can be determined by the external control unit 34b, thus integrating the above-described function of the unit of internal control 56 in the external control unit 34b. In this case, the internal control unit 56 can be omitted and the sensor measurements are supplied directly to the internal signal transmitter 82 which sends the measurements to the external signal receiver 34c and the external control unit 34b. The energy balance and the currently required amount of energy can then be determined by the external control unit 34b based on those sensor measurements.

Therefore, the present solution employs the feedback of the information indicating the required energy, which is more efficient than previous solutions because this is based on the current use of the energy that is compared to the received energy, for example with respect to the amount of energy, the difference in energy, or the rate of energy reception compared to the rate of energy used by the device 10. The device 10 can use the energy received for the consummation or to store the energy in a storage device of energy or Similary. The different parameters proposed above would be used in this way if it is relevant and necessary and then as a tool to determine the current energy balance. However, such parameters may also be necessary per se for any action internally incorporated to specifically operate the device.

The internal signal transmitter 82 and the external signal receiver 34c can be implemented as separate units using the appropriate signal transfer media, such as radio, IR (Infrared) or ultrasonic signals. Alternatively, the internal signal transmitter 82 and the external signal receiver 34c can be integrated into the implanted power transformer device 30 and the external power source 34a, respectively, to communicate control signals in a reverse direction relative to the transfer of energy, basically using the same transmission method. The control signals can be modulated with respect to frequency, phase or amplitude.

To conclude, the power supply configuration illustrated in Figure 26 can basically function in the manner that follows. The energy balance is determined first by the internal control unit 56. A control signal that reflects the required amount of energy is also formed by the internal control unit 56, and the control signal is transmitted from the internal signal transmitter 82 to the external signal receiver 34c. Alternatively, the energy balance can be determined by the external control unit 34b instead depending on the implementation, as mentioned above. In that case, the control signal can carry results from the quantization of various sensors. The amount of energy emitted from the external power source 34a can then be regulated by the external control unit 34b, based on the determined energy balance, for example in response to the received control signal. This process may be repeated intermittently at certain intervals during the current energy transfer, or may be running on a more or less continuous basis during the energy transfer.

The amount of energy transferred can be regulated in general by adjusting various transmission parameters in the external power source 34a, such as voltage, current, amplitude, wave frequency and pulse characteristics.

A method for controlling the transmission of the wireless energy supplied to an electrically operable reflux disease treatment device implanted in a patient. The wireless energy E is transmitted from an external power source located outside the patient and is received by an internal energy receiver located inside the patient, the internal energy receiver that is connected to the device 10 to directly or indirectly supply the received energy to the patient. same. An energy balance is determined between the energy received by the internal energy receiver and the energy used for the device 10. The transmission of the wireless energy E from the external energy source is then controlled based on the determined energy balance.

A system is also provided to control the transmission of the wireless energy supplied to an electrically operable motion restriction device 10 implanted in a patient. The system is adapted to transmit the wireless energy E from an external power source located outside the patient that is received by an implanted power transformer device located within the patient, the implanted power transformer device is connected to the device 10 to supply direct or indirectly the energy received to it. The system is further adapted to determine an energy balance between the energy received by the implanted energy transforming device and the energy used for the device 10, and to control the transmission of energy. the wireless energy E of the external energy source, based on the determined energy balance.

The functional parameter of the device is correlated with the transfer of energy to charge the internal energy source.

In still an alternative embodiment, the external source of energy is controlled from outside the body of a patient to release the electromagnetic wireless energy, and released electromagnetic wireless energy is used to operate the device 10.

In another embodiment, the external source of energy is controlled from outside the body of a patient to release the non-magnetic wireless energy and the released non-magnetic wireless energy is used to operate the device 10.

Those skilled in the art will understand that various prior embodiments according to Figures 14-26 could be combined in many different ways. For example, the polarized energy operated electric switch 38 could be incorporated in any of the embodiments of Figures 12, 15-21, the hydraulic valve changing device 54 could be incorporated in the embodiment of Figure 24, and the gearbox 74 could be incorporated in the modality of Figure 33. It should be noted that the switch could simply mean any electronic circuit or component.

The wireless transfer of energy to operate the motion restriction device 10 to allow non-invasive operation has been described. It will be appreciated that the device 10 can be operated with the wire the energy attached as well. One such example is shown in Figure 26, wherein an external switch 84 is interconnected between the external power source 34a and an operating device, such as an electric motor that regulates the device 10, by means of power lines 86 and 88. An external control unit 34b controls the operation of the external switch to effect the good operation of the device 10.

Hydraulic or pneumatic drive Figures 28-31 show in more detail block diagrams of four different modes of hydraulically or pneumatically actuation a motion restriction device according to the invention.

Figure 28 shows a system for treating reflux disease as described above with. The system comprises a device 10 and additionally a separate regulating tank 46, a one way pump 44 and an alternating valve 54.

Figure 29 shows the device 10 and a fluid reservoir 46. When moving the wall of the regulating reservoir or change the size of it in any other way, the adjustment of the device can be carried out without any valve, only by the fluid free passage at any time when moving the wall of the tank.

Figure 30 shows the device 10, a two-way pump 44 and the regulating tank 46.

Figure 31 shows a block diagram of a reverse servomechanism system with a first closed system that controls a second closed system. The servomechanism system comprises a regulation tank 46 and a servomechanism tank 90. The servo tank 90 mechanically controls a movement restriction device 10 through a mechanical interconnection 94. The device 10 has an expandable / contactable cavity. This cavity is preferably expanded or contracted by supplying the hydraulic fluid of the larger adjustable reservoir 92 in fluid connection with the device 10. Alternatively, the cavity contains the compressible gas, which can be compressed and expanded under the control of the servo tank 90 The servomechanism reservoir 90 may also be part of the device itself.

In one embodiment, the regulation reservoir is placed subcutaneously under the patient's skin and is operated by pushing the external surface thereof through half a finger. This reflux disease treatment system is illustrated in Figures 32-c. In Figure 31, a flexible subcutaneous regulating reservoir 46 is shown connected with a bulging servo tank 90 by means of a conduit 48. This bellows-shaped servomechanism reservoir 90 is comprised of a flexible motion restriction device. 10. In the state shown in Figure 32a, the servomechanism tank 90 contains a minimum of fluid and most fluid is in the regulating tank 46. Due to the mechanical interconnection between the servomechanism tank 90 and the device 10, the external shape of the device 10 is concentrated, that is, it occupies less than its maximum volume. This maximum volume is shown with broken lines in Figure 32a.

Figures 32a-32c show a state where a user, such as the patient in whom the device is implanted, presses the regulating tank 46 so that the fluid contained therein is flowed through the conduit 48 and into the reservoir of servomechanism 90, which, thanks to its bellows shape, expands longitudinally. This expansion in turn expands the device 10 so that it occupies its maximum volume, thereby stretching the stomach wall (not shown), with which it makes contact.

The regulating tank 46 is preferably provided with a means 46a to maintain its shape after compression. This means, which is shown schematically in Figure 32c, will thus keep the device 10 in a stretched position also when the user releases the regulating tank. In this way, the regulation reservoir functions essentially as a switch for the reflux disease treatment system.

An alternative embodiment of the hydraulic or pneumatic operation will now be described with reference to Figures 33 and 34a-34c. The block diagram shown in Figure 33 comprises a first closed system that controls a second closed system. The first system comprises a regulating tank 46 and a servomechanism tank 90. The servo tank 90 mechanically controls a larger adjustable reservoir 92 through a mechanical interconnection 94. A motion restricting device 10 having an expandable cavity / contactable which in turn is controlled by the largest adjustable reservoir 92 by the hydraulic fluid supply of the largest adjustable reservoir 92 in fluid connection with the device 10.

An example of this embodiment will now be described with reference to Figure 34a-34c. As in the modality above, the regulation reservoir is placed subcutaneously under the patient's skin and is operated by pushing the external surface thereof by means of a finger. The regulating tank 46 is in fluid connection with a bellows the shaped servo tank 90 by means of a conduit 48. In the first closed system 46, 48, 90 shown in Figure 32a, the servomechanism tank 90 contains a minimum of fluid and most of the fluid is in the regulation tank 46.

The servomechanism tank 90 is mechanically connected to a larger adjustable reservoir 92, in this example it also has a bellows shape, but with a larger diameter than the servo tank 90. The larger adjustable reservoir 92 is in fluid connection with the device 10. This means that when a user pushes the regulating tank 46, thus displacing the fluid from the regulating tank 46 to the servo reservoir 90, the expansion of the servomechanism reservoir 90 will displace a larger volume of fluid from the larger adjustable reservoir 92 to the device 10. In other words, in this reverse servomechanism, a small volume in the regulation reservoir is compressed with a higher force and this forms a movement of a larger total area with less force per unit area.

As in the previous modality described in above with reference to Figures 32a-32c, the regulating tank 46 is preferably provided with means 46a to maintain its shape after compression. This means, which is shown schematically in the figure, will thus maintain the device 10 in a stretched position also when the user releases the regulating tank. In this way, the regulation reservoir functions essentially as a switch for the reflux disease treatment system.

In Figure 35, a flow diagram illustrating steps carried out when implanting a device according to the present invention. First in a step 102, an opening is cut in the abdominal wall. Then, in a step 104 an area around the stomach is dissected. With that, in a step 106 at least one movement restricting device according to the invention is placed in contact with the stomach wall, particularly the wall of the fundus. The stomach wall is then sutured in a stage 108.

Method for restoring the location of the cardia and fundus Figure 36 shows how an instrument 200 which has the at least one flexible part 201 is inserted into the esophagus 24 of a patient suffering from a hiatal hernia 202 where a part of the esophagus 24 and fundus 16 which is supposed to be located under the diaphragm 18 has moved through the opening of the hiatus 18a to a position above the diaphragm 18.

In Figure 37 it is shown how, in a subsequent step, a member 203 having a greater cross-sectional area than the instrument 200 is released from the instrument 200. The member 203 is adapted to have a transverse that is greater than the opening of the heart. This can be achieved by the radial expansion of the member 203. The instrument 200 is then pushed in a proximal direction so that the cardia 14 and the fundus 16, or part of the fundus 16, diaphragm incorrectly located above 18, slide through. from the hiatus opening 18a again to a correct position below the diaphragm 18.

Figure 38 shows an alternative method to that shown in Figure 37 which is an embodiment of the invention. In many aspects, this Figure 38 is similar to Figure 37. In Figure 38, the instrument 200 is adapted to free a balloon member 204 to the proximal end 205 of the instrument 200 in the lower part of the stomach 206, and using to the balloon member 204 for pushing the instrument 200 against the lower wall portion of the stomach 207 so that the cardia 14 and the fundus 16 or part of the fundus 16 slide through the hiatus opening 18a to a position below the diaphragm 18 Figure 39 shows still an alternative method which is one embodiment of the invention. Again, this Figure is in many ways similar to Figure 37. However, in the method of Figure 39 it involves joining member 203 to stomach wall 207 by a fixation 208. As described above the instrument is then pushed in a proximal direction tan cardia 14 and fundus 16 o, part of fundus 16, slides under diaphragm 18.

Figure 40 shows how the fundus 16 and cardia 14 are located in a position below the diaphragm 18 after it has been pushed through the hiatus opening 18a by the instrument 200.

Figure 41 shows a subsequent stage of the method. After the fundus 16 and cardia 14 has been pushed into its correct position under the diaphragm 18, the wall of the fundus 16a is fixed to the lower part of the esophagus 24. This is accomplished by using a member 209 in the proximal part 205 of the instrument 200 which is capable of providing sutures or staples 210. Fixation hinders movement of cardia 14 and fundus 16 to a position above diaphragm 18.

Other methods according to the invention are briefly described below.

A method for treating reflux disease of a patient comprises the step of implementing a system of reflux disease treatment according to the invention in the body of a patient.

A method for using the system for treating reflux disease according to the invention comprises the step of regulating the device postoperatively to prevent reflux.

A method for surgically placing a motion restricting device according to the invention in a patient comprises the steps of cutting an opening in the abdominal wall of the patient, dissecting the area around the stomach, placing a motion restriction device attached to the wall of the stomach, and suturing the wall of the stomach.

A method for using a reflux disease treatment system, postoperatively controlled from outside the body, by regulating the device, comprises the steps of filling a volume attached to a part of the stomach wall, and regulating the device from outside the body of a patient to affect reflux of the patient.

A method for using a movement restriction device comprises the steps of filling a volume in a first part of the stomach wall that places a first part of the device, filling a volume in a second part of the stomach wall that places a second part of the device, and regulates the devices from outside the body of a patient to affect reflux of the patient.

A method for treating reflux disease in a patient comprises the steps of inserting a needle or tube as the instrument into the abdomen of a patient's body, using the needle or tube as the instrument to fill the patient's abdomen with gas that thus the abdominal cavity is multiplied, placing at least two laparoscopic trocars in the body of a patient, inserting a camera through one of laparoscopic trocars in the abdomen of the patient, inserting at least one dissection tool through one s at least two laparoscopic trocars and dissection of an area of intentional placement of at least a portion of the patient's stomach, placement of a movement restriction device according to the invention in the wall of the fundus of the stomach, invaginate the device in the wall of the fundus of the stomach, suturing the wall of the stomach to keep the device in place, suturing the fundus Stomach towards the lower part of the esophagus, and prevent the cardia to slide through the diaphragm into the thorax. Using the method and device as described here will provide a treatment of Gastroesophageal Reflux Disease that is very effective and does not suffer from complications, such as the damage of tissue migration and unwanted nonwoven in the tissue.

The filler body of the device can be adapted to be pushed or removed through a trocar for laparoscopic use, wherein the trocar has a diameter that is smaller than the relaxed diameter of the body. The filler body may include an outer wall and a hollow gas filled internal part that allows the body to pass through the trocar. Alternatively, the filler body may include an outer wall and an inner part filled with hollow fluid that allow the body to pass through the trocar. In the latter case, the fluid can be a gel. The filler body can additionally include multiple parts that can be inserted into the trocar, and this can then be assembled into a unit product unit within the body of a patient, allowing the filler body to pass through the trocar. The filler body may include an outer wall and a hollow compressed internal part that is filled with a fluid or gel after insertion into the body of a patient. Power additionally includes an injection orifice that can be used to fill the filler body with a fluid after insertion into the body of a patient through the injection port.

The filler body of the device can be an elastic compressible material, allowing the body .refiner pass through the trocar. The filler body can be made of a material that is softer than 25 shore, or even 15 shore.

The filler body may also include an outer wall that substantially incorporates the shape of a ball. The filler body may also include at least one support device adapted to be used for pushing or removing the filler body through a trocar for laparoscopic use. The support device can be adapted to maintain an extension of the device that is adapted to be maintained by a surgical instrument. The holding device can also maintain a thread or band inserted through the holding device. The holding device can also be at least partially placed inside the external wall of the filler body. The filler body of the device can preferably have a size that is larger than the intestinal outlet of the stomach to prevent ileus if the ball, as a complication, should sign the stomach. Preferably, the body has the smallest outer diameter between 30 mm and 40 mm or greater. Preferably, the body has the smallest outer circumference between 30 mm and 150 mm.

Preferred embodiments of a device for treating reflux disease have been described, system that comprises. a device for treating reflux disease, and a method according to the invention. One skilled in the art understands that these could be varied within the scope of the appended claims. In this way, although the different characteristics have been described in specific modalities, it will be appreciated that these can be combined in different configurations when applicable. For example, although the hydraulic control has been described in conjunction with the configuration of the device of Figure 4A-4B, this can also be applied to the configurations of the device of Figures 2A-2B and 3A-3B.

It is important that the implanted reflux treatment device be firmly held in place in the wall of the stomach where it invaginates. For this purpose, the reflux treatment device can be provided with one or more through holes adapted to receive sutures or staples used for the fixation of the invagination. Such an embodiment is shown in Figure 42, wherein the reflux treatment device 10 is provided with a row of holes 10 provided in a protuberance similar to a protruding flange in the reflux treatment device. In this embodiment, the row of holes extends along the longitudinal axis of the reflux treatment device.

Figure 43 illustrates how the sutures 314 are provided so that they pass the stomach wall 12a and through the holes 10i. In this way, the reflux treatment device is fixed in place in the formed sachet of the stomach wall and thus prevented from slipping.

Although a plurality of holes is illustrated in Figure 42, it will be appreciated that an individual orifice is sufficient to obtain improved fixation of the reflux treatment device 10.

Figure 44 illustrates a reflux treatment device provided with an inlet port lOh. The reflux treatment device is invaginated in the wall of the stomach and the inlet port lOh is available for connection with a tube or the like of the abdominal area of the patient.

Figure 45 illustrates an invaginated reflux treatment device where, instead of an inlet orifice, a fixed tube 10O extends into the abdominal area of the patient.

Figure 46 is a figure similar to Figure 44 but also illustrates the tunneling of a connecting tube 10O in the wall of the stomach between the inlet port lOh and the reflux treatment device 10.

It has been shown that the shape of the device Reflux treatment can incorporate many different forms. It will be appreciated that also the material of the reflux treatment device may vary. It is preferred that the reflux treatment device be provided with a coating, such as Parylene, polytetrafluoroethylene (PTFE), or polyurethane coating, or a combination of such coatings, i.e., a multilayer coating. This multilayer coating or coating improves the properties of the reflux treatment device, such as its resistance to wear.

In one embodiment, the reflux treatment device comprises an inflatable device expandable to an expanded state. In this case, the inflatable device is provided with an inlet port for a fluid and adapted to be connected to a gastroscopic instrument. This mode will now be described in detail with reference to Figures 47a-47d.

An inflatable reflux treatment device in its unexpanded state is shown in Figure 47a. It is essentially a device similar to a deflated balloon 10 that has an inlet port lOh. In this state, the inflatable device has a diameter of a few millimeters at most, allowing it to be inserted into the stomach through the patient's esophagus by means of a gastroscope, the instrument 600 resembling a tube, represented in FIG.

Figure 47b. The instrument comprises an outer tubular part 600a and an internal tubular part 600b that can be displaced longitudinally relative to the outer tubular part. The internal tubular piece is provided with a cutter in the form of a cutting edge 615 to the distal end thereof. This cutting edge can be used to cut a hole in the wall of the stomach, as will be explained in detail in the following.

When the instrument reaches a wall of the stomach, see Figure 47c, the internal tubular part is presented from its position in the external tubular piece and in contact with the stomach wall 12a. The cutting edge 615 of the internal tubular part then cuts a hole in the wall of the stomach so as to allow the subsequent insertion of the reflux treatment device 10 into and through this orifice, see Figure 47d. In order to push the reflux treatment device through the hole, a piston 602 can be provided in the instrument. In this way, the instrument further comprises a piston 602 adapted to push a deflated reflux treatment device 10 from a position on the internal tubular part, this position shown in Figure 47b, to a position outside the internal tubular part. , which is shown in Figure 47d.

In order to protect the deflated reflux treatment device 10 from the cutting edge 615 of the internal tubular part, an additional protective tubular piece (not shown) can be provided around the reflux treatment device.

An intraluminal method to invaginate a reflux treatment device 10 on the exterior of the stomach wall 12a will now be described with reference to Figures 48a-48i. Initially, an instrument 600, preferably a gastroscopic instrument, is inserted into the patient's mouth, see Figure 48a. The instrument comprises an injection device 601, 602 for injecting the fluid or a device into the patient's stomach. The instrument 600 further comprises a control unit 606 adapted to control the operation of the instrument. To this end, the control unit 606 comprises one or more steering devices, in the embodiment shown in the Figure in the form of two control levers 603 and two control buttons 604. A display 605 is provided for the demonstration of the image provided by a camera (not shown) configured to the outer end of the elongated member 607, see Figures 48e-48i. A light source (not shown) can help the camera.

The instrument is inserted further into the esophagus and into the patient's stomach, see Figure 48b.

By means of the instrument 600, a hole 12b is formed in the wall of the stomach 12. To this end, the instrument is provided with one or more cutters 615 at the distal end thereof, for example in the manner described above with reference to the Figures 47a-47d. These cutters can of course be designed in different ways, such as a toothed drum cutter that rotates about the central axis of the pipe-like instrument. The instrument 600 is hollow providing a space for the reflux treatment device 10 in its deflated state.

After a hole is cut in the wall of the stomach, the distal end of the instrument 600 is inserted into and through the hole 12b so that it ends outside the stomach wall 12a. This is shown in Figure 48c, showing a side view of stomach 12, and Figure 48d, which is a sectional view through the stomach of Figure 48c incorporated along lines Vd-Vd. The deflated reflux treatment device 10 is then inserted into the abdominal area.

The instrument 600 is adapted to form a bag or pocket outside the stomach 12 around the hole 12b in the stomach wall. Such an instrument and the method for providing the sachet will now be described.

Figures 48e-48i show a laparoscopic or gastroscopic instrument to invaginate a device of reflux treatment 10 in the stomach wall 12a of the patient creating a sachet of stomach wall 12a material where the reflux treatment device is placed. The instrument, generally designated 600, which may comprise the features described above with reference to Figures 47a-47d, comprises an elongated member 607 having a proximal end and a distal end, elongated member 607 having a smaller diameter that of the patient's esophagus and be flexible such as to allow the flexible elongated member 607 to be introduced with its distal end first through the narrowing of patients, esophagus and in the stomach 12 to the stomach wall 12a.

The stomach penetration device or the cutter 615 is provided in the elongate member 607 at the distal end thereof to penetrate the stomach wall 12a to form a hole in the stomach wall 12a, to allow the elongated member 607 to be introduced through the stomach wall 12a. of the hole. The stomach penetration device 615 could be adapted to be operable to retract the stomach penetration device 615 after the fundus wall of the stomach 12a has been penetrated, so as not to further damage the tissue within the body. The instrument further comprises a special support device 609 provided in the elongated member 607 in the side next to the penetration device 615.

The elongated member further comprises an expandable member 611 that is adapted to expand after the elongated member has penetrated the stomach wall 12a and thus aids in the creation of a cavity or pocket adapted to maintain the reflux treatment device 610. Expandable member 611 may comprise an inflatable circular balloon provided circumferentially around the distal end portion of flexible elongate member 607.

The steps of the method when invaginating the reflux treatment device will now be described in detail. After the instrument 600 as inserted into the stomach 12, the stomach penetration device 615 is placed in contact with the wall of the stomach 12a, see Figure 48e. The stomach penetration device or the cutter 615 is then carried to form the hole 12b in the wall of the stomach, where after at least the expandable member 611 is brought through the hole 12b in the wall of the stomach. The special support device 609 in this step is brought to a support state where it expands radially to form an essentially circular stirrup surface to the stomach wall 12a, see Figure 48f. In this way, the insertion of the stomach penetration device 615 and the expandable member 611 through the hole 12a in the stomach wall is limited with the position shown in Figure 48f.

Expandable member 611 then expands. In the case the expandable member comprises a balloon or the like, air or other fluid is injected into it.

The portion of the elongated member 607 comprising the expandable member 611 is then retracted in the proximal direction, as indicated by the arrow in Figure 48g, removed from the stomach wall 612 in a basket-like structure by the support device. special 609 A suture or staple device 608 is additionally provided, such as a device connected to the elongated member 607 or as a separate instrument. The suture or staple member comprises an end of sutures or staples 613 that is adapted to close the cavity or pouch by means of sutures or staples from stomach to stomach 14.

In a further step, illustrated in Figure 48h, an inflatable reflux treatment device 10 is placed in its deflated state in the basket as a structure. The reflux treatment device 10 is then inflated to its inflated or expanded state, see Figure 48i. This inflation of the reflux treatment device 10 can be carried out by injecting a fluid or a gel in the reflux treatment device after inflation. This can also be done by injecting a material that is allowed to cure, thereby creating a solid device 10. In this way, the reflux treatment device 10 shown in Figures 48h and 48i can illustrate a balloon-like device that is subsequently filled with the fluid or gel or alternatively a material that is simply injected into the basket-shaped structure by the stomach wall 12a.

The fluid that is used to fill the reflux treatment device 10 could be any fluid suitable for filling the inflate device 10, such as a saline solution. In another embodiment, when this fluid is a fluid that is adapted to be transformed into a solid state, the fluid could be fluid polyurethane.

In order to minimize or completely eliminate the effusion, the fluid is isotonic, that is, it has the same osmolarity as the fluids of the human body. Another way to prevent diffusion is to provide a fluid comprising large molecules such as iodine molecules.

The sutures or staples from stomach to stomach are preferably provided with fixation portions that show a structure, such as a network-like structure, adapted to be in contact with the wall of the stomach. stomach to promote the growth of human tissue to ensure long-term placement of the reflux treatment device attached to the stomach wall.

After the inflatable device 10 has been inflated, partly or completely, the inlet 10b (not shown in Figures 48h and 48i) of the reflux treatment device 10, is sealed and the instrument 600 is retracted from the orifice 12b, which is subsequently closed in some suitable manner, such as by means of the instrument 600. The instrument is then removed from the stomach 600 and the inflatable device 10 in its inflated or expanded state is invaginated by a portion of the patient's stomach wall. outside of the stomach wall. During one or more of. In the steps described above, the stomach can be inflated with the gas, preferably by means of the gastroscopic instrument.

The reflux treatment device 10 described in the foregoing with reference to Figures 48a-48i has been described as an inflatable reflux treatment device. It will be appreciated what is also an elastic reflux treatment device with an elasticity permit compression for insertion into a gastroscopic instrument and which expands to an expanded state after leaving the instrument.

The apparatus for treating reflux may have the Additional functionality to treat obesity. In such an embodiment, the reflux treatment device may be a volume filling device that fills a volume of the stomach and thereby creates satiety.

The embodiment shown in Figure 49a shows that an elongated motion restricting device 310 having a proximal portion 310 'and a remote portion 310". The device 310 invaginates into the wall of the stomach with its proximal part 310 'close to and at least partially greater to the cardia of the patient 14 when the patient is in a permanent position and fixed to a position above the cardia area 14c by a fixation, such as sutures or staples 22. For example a direct or indirect fixation to the diaphragm muscle or other muscle tissue can be provided. As an alternative, a direct or indirect fixation to the esophagus may be provided above and close to the angle or His. In this embodiment, the proximal part of the device 310 'rests in a position against the wall of the fundus stomach when it is implanted and that also fills a volume above the area of the cardia 14c between the cardia and the diaphragm muscle so that the cardia it avoids slipping into the chest cavity, whereby reflux disease is avoided. The remote part 310"stabilizes and maintains the proximal part and is of sufficient length to exert the effect that is stabilizes. The remote part 310"also has a sufficient volume to reduce the volume of the food cavity and thus the device obtains an additional functionality to treat obesity.

In this preferred embodiment, the apparatus for treating reflux disease comprises two or more segments of the motion restriction device adapted to form the motion restricting device 310. In this embodiment, there are a plurality of segments of the motion restriction device. spherical in the form of small balls that are contained in a segment of movement restriction device in the form of an outer layer or cover, which is preferably elastic or flexible. In this way, the outer layer can be inserted into the stomach as a separate part which is subsequently filled with a plurality of small segments of the movement restriction device preferably spherical, or polyhedral. This method will be better explained with reference to Figures 117a-117c.

By providing a motion restricting device 310 with a plurality of segments of the movement restriction device, the motion restricting device 310 readily adapts to the movement of the stomach in which it invaginates.

In an alternative embodiment, the small segments of the movement restriction device are inserted or injected into a pre-formed pocket on the part of the patient's stomach wall without any outer layer or cover for collection. This embodiment is illustrated in Figure 49b and corresponds to the method described below with reference to Figure 117a-117c.

In order to provide a motion restriction device that is more stable at the next part 310 ', this part can be made from a different configuration of the remote part 310". Thus, in an embodiment shown in Figure 49c, the proximal part 310 ', which is fixed to a position above the area of the cardia 14c, comprises a larger shaped part or segment ball, while the distant portion 310" it comprises a plurality of small segments of the movement restriction device. This embodiment combines the advantages of a stable proximal part 310 'used to prevent reflux with a more adaptable remote part 310' used as a volume filler device for treating obesity. In general terms, the near and distant parts can have different configurations and contents, independent of each other. This content can be a mixture of solid and fluid content, such as fluid that increases or reduces friction.

Such a device 310 may be used to maintain electronic components and / or a power source and / or hydraulic fluid. The hydraulic fluid from that device can be distributed to several smaller inflatable device areas to vary the stretch area from time to time and avoid any possible more permanent stretch effect of the stomach wall. Even mechanically several stretch areas can be used.

In an alternative embodiment, which is shown in Figure 50, the volume of an inflatable reflux treatment device 310 may be in fluid connection with the one or more preferably smaller inflatable devices or chambers 10b. These cameras are adapted to communicate with fluid or air moving between the chambers.

Thus, the main chamber 310 is adapted to, with its main volume to be a reflux treatment device to reduce the size of the food cavity and to treat reflux disease and one or several small chambers are adapted to operate as the devices inflatable to treat obesity, where the main chamber is adapted to communicate with fluid or air to the small chambers that cause a stretching effect on the stomach wall also treating in consequence obesity.

Figure 51a shows an embodiment with a combination of an invaginated volume filling device in the central or lower portion of the stomach and an invaginated stretching device in the upper portion or the fundus of the patient's stomach. These two devices serve to treat obesity.

The volume filling device 399 fills a volume of the stomach creating satiety. The stretching device stretches the stomach wall. This stretches the tissue that adjusts an endogenous signaling that forms satiety. This mimics the stretch effect to fill the stomach with food. Thus, in Figure 51a there is shown an adjustable volume filling device 399, which is invaginated in the stomach wall of the stomach of a patient 312. Furthermore, an adjustable stretching device 350 with the function previously described is invaginated in the fundus wall of the patient's stomach. It is preferred that the volume filling device 399 be substantially larger than the stretching device 350.

The volume filling device 399 and the stretching device 350 can be adapted to treat reflux. In one embodiment, the volume filler device and the stretching device are placed for prevent the cardia 14 from slide up through the opening of the hernia 18a to a position above the diaphragm 18.

The volume filling device 399 and the stretching device 350 are in fluid communication with each other through a first fluid tube 352, where a pump 354 is provided. The pump 354 is under the control of an energy transforming device 330 , which is adapted to supply the pump 350 with power through a power supply line 356. The power transformer device 330 also connects to a sensor 319 provided in the patient's esophagus so that food intake can be detected The reflux treatment device 10 and the stretching device 350 are also in fluid communication with each other through a second fluid tube 358, which preferably has a smaller cross-sectional area than the first fluid tube 352.

The operation of this arrangement is as follows. The volume filling device 399 functions as in the above described embodiments, ie, it reduces the size of the food cavity of the patient's stomach 12. Furthermore, when the stretching device 350 is enlarged by pumping the fluid from the volume filling device 10 and to the stretching device 350 by means of the pump 354, the fundus wall of the stomach is stretched, creating a feeling of satiety for the patient. In this way, for example when the food intake is detected by means of the sensor 319, the fluid is automatically pumped into the stretching device 350 to increase the feeling of satiety and consequently limits the intake of food.

When the fluid has been injected into the stretching device 350, the internal pressure in that part is higher than the internal pressure in the reflux treatment device 399. This difference in pressure will form a fluid flow in the second, tube preferably narrower 358 of the stretching device 350 to the reflux treatment device 399. The flow rate will be determined by inter alia the difference in pressure and the cross-sectional area of the second tube 358. It is preferred that the second tube be in this dimensioned manner, that the pressures in the volume filling device 399 and the stretching device 350 will return to equilibrium after 3 hours after the fluid has been injected into the stretching device 350 to create the feeling of satiety.

In this embodiment, the function of the second tube 358 is to allow the fluid to return from the stretching device 350 to the volume filling device 399.

It will be appreciated that this function can also be performed by the pump 354 in the first tube 352 and that the second tube 358 can then be omitted.

Figure 51b illustrates a modality similar to that illustrated in Figure 51a. In this way, an adjustable volume filling device 310 is provided, which invaginates into the stomach wall of the stomach of a patient 312. In addition, an adjustable stretching device 350 with the function previously described is invaginated in the wall of the fundus of the patient. stomach of the patient. It is preferred that the volume filler device 310 be substantially larger than the stretching device 350.

The volume filler device 310 and the stretching device 350 are in fluid communication with each other through a first fluid tube 352, and a second fluid tube, which preferably has a smaller cross-sectional area than the first tube. However, instead of a pump, a check valve 360 is provided in the first fluid tube 352 in place of an activated pump. This check valve 360 allows the fluid to flow in the direction of the volume filling device 310 and the stretching device 10 but not vice versa. This means that this mode can not be fully energized. Instead, it works according to the following principles.

When the stomach food cavity 312 is essentially empty, there is a state of equilibrium between the internal pressure of the volume filling device 310 and the stretching device 350. In this state, the stretching device is in a non-expanding state, it is To say, this does not stretch a part of the fundus wall of the stomach and thus does not form a feeling of satiety.

When the patient begins to eat, the food will enter the stomach food cavity 312. This will form the increased pressure in the wall of the stomach where the volume filling device 310 invaginates and the internal pressure in that part will increase. Also, the muscles of the stomach wall will begin to process food in the alimentary cavity by contraction, which also contributes to an increased internal pressure in the volume filler device 310.

Since the internal pressure in the stretching device 350 will remain essentially unchanged, because this is located in the upper part of the stomach 312 where no food exerts a pressure on the stomach wall, a fluid flow will form through the first and second fluid tubes 352, 358 in the direction of the volume filling device 310 and to the device of stretching 350. This to your. the volume of the stretching device 350 will increase, which, by stretching the fundus wall of the stomach, will provide a feeling of satiety to the patient.

A fluid flow of the stretching device 350 to the volume filling device 310 through the second tube 358 will return the pressure of these devices to equilibrium as described above with reference to Figure 51a Similarly, Figure 51c illustrates a mode where the stretching device 350 can be actively regulated by manually pressing an adjustment reservoir that is provided subcutaneously under the skin of the patient. In this way, a regulation reservoir 317 for fluids is connected to the inflatable device by means of a conduit 318 in the form of a tube. The stretching device 350 is thus adapted to be regulated, non-invasively, by fluid in motion or air from the regulating tank 317 to the chamber formed by the inflatable device. The adjustment of the stretching device 350 preferably comprises a reverse servomechanism, ie a small volume is operated, for example, by the patient's finger and this small volume is connected to a larger volume.

The volume filling device 310 has of Preferably an essentially round shape does not damage the wall of the stomach. An example thereof is shown in Figure 51d, wherein the volume filling device is essentially ovoid. In another preferred embodiment, the volume filler device is slightly bent, as the embodiment shown in Figure 51e. However, since the stomach wall is powerful many different shapes, shapes, and dimensions can be used. In one embodiment, the volume filler device has a diameter of approximately 40 millimeters and a length of approximately 120 millimeters, resulting in a volume that is approximately one-half the volume of the patient's stomach. However, it is preferred that the maximum circumference of the volume filling device is at least 30 millimeters, more preferably at least 50 millimeters, and even more preferably at least 80 millimeters.

It is not necessary that the volume filling device be elongated. In the embodiment shown in Figure 51f, the volume filler device 310 is essentially spherical or ball-shaped. In order to fill the stomach, two or more volume filling devices can be combined to achieve the desired decrease in the food cavity of the patient's stomach.

It has been mentioned that the filler device of Volume is secured by sutures or staples from stomach to stomach. In order to further improve the fixation, the volume filler device can be provided with a wafer portion having the diameter smaller than the maximum diameter of the volume filler device. Such a volume filling device having a size portion 10a is shown in Figure 51g.

The volume filler device 10 may comprise at least two interconnectable portions so that each portion is easier to insert into the stomach and additionally through a hole in the wall of the stomach. In this way, Figure 51h shows a volume filling device comprising the two more or less spherical subparts 310b, 310c interconnected by a portion with which it preferably has the smallest diameter. The portion with the smallest diameter may comprise interconnection means with a reversible function that allows the subsequent disconnection of the two interconnected subparts 310b, 310c. Such means may comprise a bayonet plug, screw connection or the like, designated 310d in Figure 51h. Alternatively, the portion with the smallest diameter may comprise a fixed interconnection, such as resilient hooks that immobilize provided in one of the subparts 310b, 310c and engagement of the edge of an orifice. provided in the other of subparts 310b, 310c.

The configuration of the volume filling device 310 is not limited to a portion of size 310a. Thus, in Figure 51i there is shown a volume filling device with two size portions.

In order to facilitate the positioning of the volume filling device, a joining means in the form of a fastening means or the like can be provided on the external surface of the volume filling device. An example thereof is shown in Figure 51j, which also shows a detailed view of a fastening means Figure 51-10e. In a preferred embodiment, the attachment means is provided to a terminal portion of the volume filling device 310. In order to avoid the protruding portion on the surface of the volume filling device 310, the handle 310e is provided flush with the outer surface of the volume filling device 310 and a cavity 310f is configured to allow a tool or gripping instrument (not shown in Figures 51j) to achieve firm grip around the handle 310e.

The volume filling device may comprise a tube for filling or emptying the volume filling device of a fluid or gel. Injecting the fluid or gel into the volume filler device 310, The volume filling device is inflated to an inflated state, as will be described below. The size of the volume filler device can also be adjusted by moving fluid or gel from that to a different reservoir.

A volume filler device 310 adapted for this is shown in Figure 51k. A tube 310g is fixedly attached to the volume filling device. This tube can be fixed to a suitable instrument (not shown) or an injection hole, which will be explained in detail below.

Instead of having a tube firmly attached, the volume filling device 310 may comprise an inlet port 10 adapted to a separate pipe connection (not shown in this figure 51k).

It is important that the implanted volume filler device be firmly held in place in the wall of the stomach where it invaginates. To this end, the volume filler device can be provided with one or more through holes adapted to receive sutures or staples used for the fixation of the invagination. Such a mode is shown in Figure 51-3j, wherein the volume filling device 310 is provided with a row of holes lOi provided in a protuberance similar to a protruding flange in the filling device. of volume. In this embodiment, the row of holes extends along the longitudinal axis of the volume filling device.

Method for placing a reflux treatment device inside the stomach wall A method and an instrument for placing a reflux treatment device inside the stomach wall will now be described.

The invagination instrument described in Figures 52a-52h generally designated 630, comprises an elongated tube member 632 similar to elongate member 607 described above with reference to Figures 48a-48i. In this way, it can be connected to a control unit 606, see Figure 48a. The invagination instrument 630 further comprises a perforated suction portion 634, which is preferably elongated. The suction portion 634 shows a plurality of small holes 636, to where the air will be sucked providing suction in the tube member 632. This suction effect will be used to create a bag or sachet in a part of a stomach wall, in general designated 12a.

In other words, when the tip of the suction portion 634 is pressed against the stomach wall 12a, see Figure 52a, a small cavity will be formed in that part. When the suction portion 634 is pressed additionally against the stomach wall 12a, see Figure 52b, a larger cavity will be formed. The part of the stomach wall 12a that forms the cavity, due to the suction effect, will adhere to the suction portion 634 of the intussusception instrument 630. As the suction portion 634 is further pressed into the stomach wall 12a, see Figure 52c, a deeper cavity will be formed until the complete suction portion 634 is embedded in the cavity, see Figure 18.

The edge of the cavity in this step will be fixed by means of fasteners 638 and the suction portion removed from the instrument, see Figure 52e. A compressed elastic reflux treatment device 10 will subsequently be inserted into the cavity, see Figure 52f, for example in the manner described above with reference to Figure 47d. This compressed reflux treatment device then expands to its final shape, see Figure 52g, where after the sachet is sealed by suturing or stapling by means of the fasteners, see Figure 52h.

All the alternatives described above with reference to Figures 1A-511 are also applicable to the embodiment described with reference to Figures 52a-52h, that is, to the mode where the reflux treatment device invaginates inside the wall of the stomach.

Figures 53a-53c show an instrument for forming an invagination of the wall of the stomach that can be placed outside the stomach wall or inside the wall of the stomach depending on whether the reflux treatment device is the place in which the inside or outside of the wall. The instrument uses vacuum for such a portion of the stomach wall in the concave shape of the instrument.

It has been described how the reflux treatment device 10 invaginates into the stomach wall by means of a gastroscopic instrument. The gastroscopic instrument can be used to place a reflux treatment device outside the stomach wall as shown in Figure 1A or inside the stomach as shown in Figure 2A. In the latter case, the instruments will be used to make an incision in the stomach wall of the inside of the stomach.

It will be appreciated that abdominal methods of operation may also be used. Such methods will now be described with reference to Figures 54-55. In Figure 54 this is shown as the stomach is gained access by creating an incision 380 in the abdomen of the patient. In Figure 55 this is shown as an instrument 381 is inserted into the patient's abdomen. Any of the instruments and methods described can be selected a adapted for this purpose. Thus, for example, the reflux treatment device can be placed outside the stomach as shown in Figure 1A or inside as shown in Figure 2A. In the later case an incision is made in the wall of the stomach.

Stimulation - detailed description Figure 56 schematically shows a mode of the. heartburn and the reflux disease apparatus of the invention having some parts implanted in a patient and other parts located outside the body of a patient. In this way, in Figure 56 all the parts placed to the right of the patient's skin 2x are implanted and all the parts placed on the left side of the skin 2x are located outside the body of a patient. The apparatus of Figure 56 comprises an implanted electrical stimulation device 4, which meshes with the sphincter patient's heart to provide electrical connection thereto. A 6x implanted control unit controls the 4x stimulation device through an 8x control line. An external control unit lOx includes an external power source and a wireless remote control that transmits a control signal generated by the external power source. The control signal is received by a signal receiver included in the 6x implanted control unit, whereby the 6x control unit controls the stimulation device implanted 4x in response to the control signal. The 6x implanted control unit also uses the electrical energy extracted from the control signal to drive the 4x stimulation device through a 12x power supply line.

Figure 57 shows an embodiment of the invention identical to that of Figure 56, except that an internal power source implanted with energy in the form of an electric battery 42x is replaced for the external power source. In this way, an external 40x control unit without any power source is used in this mode. In response to a control signal from the external control unit 40x the implanted control unit 6x drives the stimulation device 4x with the energy of the electric battery 42x.

Figure 58 shows an embodiment of the invention comprising the 4x stimulation device, the external control unit lOx, and an implanted power source 236x and an implanted switch 238x. The 238x switch is operated by the wireless energy released from the external power source of the external 6x control unit to switch between a shutdown mode, where the implanted 236x power source is not in use, and an ignition mode , where the implanted source of 236x energy supplies the energy for the energy of the device 4x stimulation.

Figure 59 shows an embodiment of the invention identical to that of Figure 58, except that also the control unit 6x is implemented, in order to receive a control signal from the wireless remote control of the external control unit lOx. The 238x switch is operated by the wireless energy of the external power source lOx to switch between a shutdown mode, where the implanted power source 236x and the wireless remote control of the external control unit lOx is not in use, that is, the 6x control unit is not capable of receiving the control signal, and a standby mode, wherein the wireless remote control is allowed to control the internal power source 236x, through the 6x implanted control unit, supplying the energy for the energy of the 4x stimulation device.

Figure 60 shows an embodiment of the invention identical to that of Figure 59, except that an energy transforming device for transforming the wireless energy into the storable energy is incorporated in the 6x implanted control unit and that the implanted power source 236x It is of a type that is capable of storing storable energy. In this case, in response to a control signal from the external control unit lOx, the implanted control unit 6 controls the switch 238x for, switching off mode, where the implanted 236x power source is not in use, to an ignition mode, wherein the 36x power source supplies the energy for the power of the 59x stimulation device.

Figure 61 shows an embodiment of the invention identical to that of Figure 60, except that a 240x energy storage device is also implanted in the patient to store the storable energy transformed from the wireless energy by the transformer device of the power unit. 6x control In this case, the implanted control unit 6x controls the energy storage device 240 to operate the switch 238x to switch between a shutdown mode, where the implanted power source 236x is not in use, and an ignition mode , wherein the implanted source of 236x energy supplies the energy for the 4x stimulation device energy.

Figure 62 schematically shows conceivable combinations of implanted components of the apparatus to achieve various communication possibilities. Basically, there is 4x implanted stimulation device, the 6x implanted control unit and the external control unit lOx that includes the external power source and the wireless remote control. As previously described, the remote control transmits a generated control signal by the external source of energy,. and the control signal is received by a signal receiver included in the 6x implanted control unit, whereby the control unit 6x controls the implanted stimulation device 4x in response to the control signal.

A 54x sensor can be implanted in the patient to detect a physical parameter of the patient, such as pressure in the esophagus. The control unit 6x, or alternatively the external control unit lOx, can control the stimulation device 4x in response to signals from the sensor 54x. A transceiver may be combined with the sensor 54x to send the information about the perceived physical parameter to the external control unit lOx. The wireless remote control of the external control unit lOx may comprise a signal transmitter or transceiver and the implanted control unit 6x may comprise a signal receiver or transceiver. Alternatively, the wireless remote control of the external control unit lOx may comprise a signal receiver or transceiver and the implanted control unit 6x may comprise a signal transmitter or transceiver. The above transceivers, transmitters and receivers can be used to send the information or data related to the stimulation device from inside a patient's body to the outside thereof. For example, the battery 32x electric can be equipped with a transceiver to send information about the charging condition of the electric battery.

Those skilled in the art will understand that various prior embodiments according to Figures 56-61 could be combined in many different ways.

Figure 63 illustrates how any of the above-described modalities of heartburn and reflux disease treatment apparatus of the invention can be implanted in a patient. In this way, a device unit implanted in the patient comprises a stimulation device in the form of a 56x band, which is wrapped around the 58x heart. The 58x band is provided with conductors that electrically contact the cardia sphincter and a 60x operating device to operate the 56x stimulation device. A 60x implanted control unit is provided for the control of the supply of electricity to the 56x band. There is a 62x implanted power transformer device to transform wireless energy into electrical energy. The 62x transformer device also includes a signal receiver. An external control unit 64x includes a signal transmitter for transmitting a control signal to the signal receiver of the implanted transformer device 62x. The 62x transformer device is capable of transforming the signal energy of the control signal into electrical energy to drive the 60x stimulation device and to activate another energy consuming implanted components of the apparatus.

Figure 64 shows the basic parts of a wireless remote control of the apparatus of the invention that includes an electrical stimulation device implanted 4x. In this case, the remote control is based on the transmission of electromagnetic wave signals, often of high frequencies in the order of 10kHz - 1 gHz, through the skin 130x of the patient. In Figure 64, all the parts placed to the left of the skin 130x are located outside the body of a patient and all the parts placed to the right of the skin 130x are implanted. Any suitable remote control system can be used.

An external signal transmission antenna 132x should be placed near a 134x signal receiving antenna implanted near the skin 130x. As an alternative, the receiving antenna 134x can for example be placed inside the abdomen of the patient. The receiving antenna 134x comprises a coil, approximately 1 -100mm, preferably 25mm in diameter, wound with a very thin wire and tuned to a specific high-frequency capacitor. A small roll is selected if it should be implanted under the patient's skin and the larger coil Choose . if it should be implanted in the patient's abdomen. The transmission antenna 132x comprises a coil having about the same size as the coil of the receiving antenna 134x, but wound with a thick wire that can handle the larger currents that is necessary. The coil of the transmit antenna 132x is tuned to the same high frequency specified as the coil of the receiving antenna 134x.

An external control unit 136x comprises a microprocessor, a high frequency electromagnetic wave signal generator and a power amplifier. The microprocessor of the control unit 136x is adapted to change the on / off generator and modulate signals generated by the generator to send the digital information through the power amplifier and antennas 132x, 134x to a 138x implanted control unit. Prevent accidental random high-frequency field trigger control commands, digital signal codes being used. A conventional numeric keypad placed in the external control unit 136x is connected to the microprocessor thereof. The numeric keypad is used to order the microprocessor to send digital signals to the power or not to drive the stimulation device. The microprocessor starts a command by applying a high frequency signal on the 132x antenna. After a short period of time, when the signal has activated the. implanted parts of the control system, the commands are sent to activate the stimulation device. The commands are sent as digital transmission blocks in the form illustrated below.

Start the Command of the Count of the Sum of pattern, 8 8 bits 8 bits checking bits of 8 bits The commands can be sent continuously during a period of rather long time. When a new stage of energy or non-energy is desired, the Bit count is increased by one to allow the implanted control unit 138x to decode and decrypt that another stage is required by the external control unit 136x. If any part of the digital transmission block is wrong, its content is not simply ignored.

Via a 140x line, a 126x implanted trigger unit extracts the energy from the high frequency electromagnetic wave signals received by the receive antenna 134x. The activating unit 126 stores the energy in a power supply, as, the larger capacitor, drives the control unit 138x and drives the electrical stimulation device 4x through a line 142x.

The control unit 138x comprises a demodulator and a microprocessor. The demodulator demodulates digital signals sent from the external control unit 136x. The microprocessor of the control unit 138x receives the digital transmission block, deciphers it and, on condition that the power supply of the activating unit 126x stores sufficient energy, drives the stimulation device 4x through a 144x line .

Alternatively, the energy stored in the power supply of the activating unit can only be used to operate a switch, and the power to drive the 4x stimulation device can be obtained from another implanted power source of relatively high capacity, for example a battery electric In this case the switch is adapted to connect the electric battery with the 138x control unit in an ignition mode when the switch is powered by the power supply and keep the electric battery disconnected from the control unit in a standby mode when the switch is not driven.

Stretching - detailed description Here follows the detailed description of two embodiments of the invention where the reflux treatment is combined with the treatment of obesity. First, modalities showing a stretching device are shown.

Invaginated in the wall of the stomach is going to understand as an object that is placed inside a cavity made of the material of the stomach wall. Intussusception allows stitches or staples from stomach to stomach that allows the object to close by means of human tissue healing.

Figure 65 shows a first embodiment of an obesity treatment apparatus. The apparatus comprises an IO stretching device implanted in a human patient. In Figure 65 the stretching device 10O is invaginated in the wall 12y of the patient's stomach 12 and the body of the stretching device 10Y is shaped to bear against the wall 12y of the stomach 12 and additionally has an external surface suitable for leaning against this wall 12y. . This means that the stretch device 10 preferably has an essentially round shape, not to damage the stomach wall. However, the stomach wall 12y is powerful so many different shapes and forms can be used.

The stretching device 10 may be attached to the wall 12a of the stomach 12 and in a variety of different ways. In the embodiment shown in Figure 65, the stretching device 10O invaginates in the stomach wall 12a. After intussusception, several sutures or staples from stomach to stomach are applied to maintain intussusception in the short term. This allows growth of the tissue. human, maintaining long-term intussusception.

By enlarging the size of the stretching device, the wall of the stomach 12 and the surroundings of the stretching device 10y are stretched since the circumference of the stretching device 10y is increased. By this stretch, the receptors in the stomach wall indicate that the stomach is complete, thus creating a feeling of fullness to the patient. Proportionally, when the IOy stretching device is contracted, the receptors indicate that the stomach is not full, thus returning the feeling of hunger.

The expansion and contraction of the IO stretch device can be carried out under the direct control of the patient. Alternatively, the expansion and contraction can be carried out according to a pre-programmed program.

Returning to Figure 65, this Figure also shows a fluid operation device, i.e., an operation, hydraulic or pneumatic device suitable for operating the stretching device, which will be described in detail in the following.

The IOy stretching device forms a fluid chamber, where the fluid is left to flow. He IO stretch device thus forms an expandable chamber that can change the volume it occupies in the wall of the stomach, thereby creating a hydraulically or pneumatically regulated stretch device.

A regulating tank 16y for fluids is connected to the stretching device 10Y by means of a duct 18 and in the form of a tube. The stretching device 10 is thus adapted to be adjusted, preferably non-invasively, by fluid in motion or air from the regulating tank 16 and to the chamber formed by the stretching device.

The regulating tank 16y can be regulated in several ways. In the mode shown in Figure 65, the regulating tank 16y is regulated by manually pressing the regulating tank 16y. In other words, the regulating tank 16y is regulated by the movement of a tank wall. It is then prefd that the regulation reservoir 16y be placed subcutaneously and non-invasive regulation achieved accordingly.

When the regulating reservoir 16y is depressed, the volume thereof decreases and the hydraulic fluid moves from the reservoir to the chamber formed by the stretching device 10Y through the conduit 18, expanding or expanding the device. stretch 10y. To fill and calibrate the fluid level of the apparatus, an injection hole 10000 is additionally provided. The injection orifice preferably comprises a single sealing membrane, such as a silicone membrane.

It will be appreciated that instead of the hydraulic operation, the pneumatic operation can be used, wherein the air instead of the hydraulic fluid moves between the reservoir 16 and the chamber formed by the stretching device 10Y. Preferably the reservoir has a closed position to hold it in the desired position. If the patient compresses the reservoir 16 and preferably stays compressed and released after pressing it again.

Any kind of hydraulic solution can be used for the stretching device. The hydraulic solution can be operated both mechanically and driven by any motor or pump as well as manually.

Figure 65 further shows a reverse servo system comprising a regulating tank 16y and a servomechanism tank 90y. The servomechanism reservoir 90y hydraulically controls a stretch device 10Y through a conduit 18y. The reverse servomechanism function is described with greater detail in Figures 97-100c Figure 66a shows the apparatus according to another embodiment where a motor 40y is adapted to move a wall of the regulating tank 16y. The regulated regulation reservoir 16y is preferably placed in the abdomen of the patient. In this modality, a wireless external remote control unit 34by, c and an external power transmission device 34a can be provided to carry out the non-invasive regulation of the motor through a power transformer device 30y, which is adapted to supply an operating device. of energy consumption, in the present example it motor 40y, with energy.

The remote control may comprise a wireless power transmitter 34a and may also act as a regulatory device for non-invasively regulating the stretching device. When the regulation is carried out by means of a remote control 34 and an internal power supply 70y to operate the regulation device is provided. The internal power source 70y can be for example a chargeable implanted electric battery or a capacitor or a device for receiving the wireless energy transmitted from outside the patient's body. The different ways of regulating the stretch device 10 will be described below with reference to Figures 77-100c.

The apparatus as shown in Figure 66a further comprises a sensor 201 and sensing of a parameter of the patient or the apparatus preferably connected to the patient's food intake. The sensor is connected to a control unit 42 and by means of a sensor signal transferring member 202y. The sensor can be used to regulate the apparatus in a fully automatic manner, i.e. the apparatus responds to a sensor signal connected to the patient's food intake, thereby affecting the control unit to operate the stretch device 10 and to stretch the 12th stomach wall and consequently creating a feeling of fullness in the patient. The sensor could be adapted to quantify the patient's dietary intake through any of temperature, blood pressure, blood flow, heartbeat, respiration and pressure and can be placed in stomach 12y, esophagus 203y or in relation to cardia 204y. According to one embodiment, the sensor is a stretch indicator that measures the contraction and / or relaxation of cardia 204y.

The apparatus as shown in Figure 66a further comprises a second conduit 222y for the backflow of the hydraulic fluid. The retroflow is adapted to form the desired sensation of satiety during a period of predetermined time where after the hydraulic fluid has again flowed in a much larger amount for the stretching device so as not to stretch the stomach wall further and in this way the feeling of hunger returns to the patient. A suitable period of time for the process is between 1 and 6 hours. According to other embodiments, the backflow occurs in the main conduit 18 and by means of a valve system connected to the conduit 18y.

In order to fill and calibrate the fluid level of the device, an injection of 100% is also provided to the orifice. The injection hole 10000 preferably comprises a single sealing membrane, such as a silicone membrane.

Figure 66b shows the apparatus according to the embodiment of fig. 66a, in a second state where the stretch device 10O expands and thus stretches the stomach wall 12y.

Figure 67a shows one embodiment, wherein two stretch devices 10"and are provided. Both stretch devices 10 '' and operate in accordance with the principles described above with reference to Figure 65. These can be adapted to post-functionally and non-invasively regulated and adapted to regulate from time to time different stretching devices the first time a first part of the stomach wall and a Stretching a second part of the stomach wall second time.

Such a stretch device 10 may be used to maintain electronic components and / or a power source and / or hydraulic fluid. The hydraulic fluid of that device can be distributed to several smaller areas of the stretching device to vary the stretching area from time to time and avoids any possible more permanent stretching effect of the stomach wall. Even mechanically several stretch areas can be used. The modality according to fig. 67a further comprises a hydraulic valve changing device 54y, implanted in the patient, for moving between the operation of the first and second stretching device 10 '' y. Alternation forms a more sustainable device since the receptors in the stomach wall are stimulated and get a longer period of recovery time between the extensions.

In Figure 67a the system is a manual system controlled by the patient as described above with reference to Figure 65, while in Figure 67b the system is powered using wireless power as described above with reference to Figure 66a .

Figures 68a-68e show different embodiments of the adapted stretch device. to be implanted in a patient. The IOy stretching device comprises a surface adapted to be in contact with the wall of the stomach 12 and when the device invaginates into the wall of the stomach. Figure 68b shows an embodiment of the stretching device wherein the stretching device comprises a fixing member 206and for suturing or stapling the stretching device to the stomach wall. The fixation member 206y could comprise holes for receiving mentioned the sutures or staples 14y, or the fixation device 206and could be penetrable such that sutures or staples can penetrate the stomach wall and fixation device 206y. 68c shows the stretching device 10O according to a mode wherein the stretching device 10O comprises an inlet member 207 and for filling the device with a fluid. The inlet member is preferably connected with a hydraulic conduit 18 and adapted to be invaginated in the stomach wall 12y. Figure 68d shows the stretching device 10O according to a mode where the stretching device 10O comprises a holding member. 208 adapted to connect with an insertion device when stretching the device 10 and inserted into a sachet for invaginase in the stomach wall 12y. Figure 68e shows the stretch device lOy of according to a modality where the stretching device has a slightly oval or ovoid shape. Figure 68e further shows the hydraulic conduit 18 attached to the stretching device 10Y. Figure 68f shows the stretching device 10O according to a mode where the stretching device is inflatable by a fluid transported through the conduit 18y. According to a modality shown in Figure 68f the conduit comprises the two sections 18a, 18b and where the first section 18a is used, the stretch device 10 is withdrawn in place, and the device 10 is filled with a suitable fluid, while the second section 18b is used for the operation of the lOy device. Figure. 68g shows the stretching device 10O according to the embodiment of fig. 68f in a deflated state. The IO stretching device is inserted through a hole in the wall of the stomach 12 and in its deflated state where after the IOy device is filled with a fluid suitable for the operation. Figure 68h shows the stretching device 10O according to a mode where the stretching device 10O comprises two portion of the moving wall 223a, 223b, which are mobile by means of a bellows structure 209 and making a flexible material. Figure 68i shows the stretching device according to a mode where the The stretching device is expandable by means of four expandable sections 210 and symmetrically placed at four sites along the surface of the stretching device, as shown in the sectional image of fig. 68i. The expandable sections 210 and are made of a flexible material to allow the sections 210y to expand when pulling the device 10 and fill with a hydraulic fluid.

Surface structure of implants The general structure of any implanted device of the invention will now be described with reference to Figure 69a-69k. The present invention relates to an implant, adapted to be post-functionally adjustable and comprising at least one expandable section, wherein the implant is adapted to be adjustable between a first collapsed state and a second expanded state. In the first collapsed state the expandable section collapses, and in the second expanded state, the expandable section expands. The outer surface of the expandable section actually comprises at least in part a surface structure having raised areas alternating with low areas. The expandable section is adapted to have, in at least one of the first collapsed state and second expanded state a first distance between adjacent raised areas sufficiently extended to prevent that the growth of the fibrotic tissue directly interconnect adjacent raised areas to a degree that compromises the ability of adjustment between a first collapsed state and a second expanded state of the implant. The expandable section further comprising connecting areas between adjacent high and low areas, further adapted to have, in at least one of the first collapsed state and second expanded state, a second distance between adjacent connecting areas sufficiently extended to prevent the growth of the fibrotic tissue directly interconnecting in the adjacent connection areas to a degree that compromises the ability to fit between a first collapsed state and a second expanded state of the implant.

According to another embodiment, the implant is substantially completely hollow or comprises a hollow body extending along substantially the entire length and / or the entire volume of the implant.

The fibrotic tissue can often have an expansion or thickness of about 0.5 mm to about 1.5 mm and therefore the distances between relevant surfaces of the surface structure elements are suitably greater than about 3 mm, therefore greater than about 2 x 1.5 mm. But according to the circumstances also distances greater than about 1.0 mm to about 3 mm may be sufficient. In cases where the fibrotic tissue can be expected to have an expansion or thickness greater than about 1.5 mm, the distances between relevant surfaces of the surface structure elements are adapted in an appropriate manner.

The surface structure may comprise raised and diminished areas and it may be suitable that also a distance between the different planes of the raised and low areas be greater than a certain threshold to facilitate the collapsible and / or expandable functionality of the implant. If the distance is too small, the collapsible and / or expandable functionality of the implant may be limited. A suitable range for distance is approximately 0.5 to 10 mm, more suitable approximately 2-8 mm and approximately 3-7 mm more suitable The surface structure may comprise different geometrical elements or shapes and any combination of such elements or forms while the above conditions for distances can be fulfilled. The surface structure can comprise, for example, edges and grooves of different shapes. The edges and grooves may each have a cross section that is example in the shape of a wedge, polygonal, in the form of a square, in the shape of a pyramid, in the shape of a truncated pyramid. Additionally, the edges and grooves have cross sections of different shapes. The surface structure may also generally comprise a bellows-like structure or a surface structure where the geometrical objectives of the same or different class (s) are placed on a surface. The geometrical objectives can be practically randomly placed on the surface or according to some reaction scheme.

One type of implant where this type of surface structure may be appropriate, are implants where the implant should have the ability to change shape and / or size substantially. Therefore, this is a case where the presence of the fibrotic tissue could substantially impede or prevent the function of the implant. But the surface structure can be used by any implant where the characteristics of the surface structure would be advantageous for the implant.

A first distance 708a between two raised areas 701, see fig. 69a, is long enough to prevent the growth of fibrotic tissue that directly connects two adjacent raised areas 707. That is, it may be possible for the fibrotic tissue to grow in the surface of the high and low areas 701, 702 and the connector areas 704. However, thanks to the expansion of the first distance 708a, fibrotic tissue is prevented from growing directly from an elevated area 701 to another adjacent raised area 701.

With the expression growing directly from a raised area 701 to another raised area 701 '' is for example meant that the fibrotic tissue grows from a raised area 701 to the other while not or only to a small degree growing in a connecting area 704 As indicated at 704a in Figure 69i, the first distance 708a can be quantified within a range 704a of the level of an elevated area 701. The expression "growing directly from an elevated area 701 to another raised area 701" also includes the situation that the fibrotic tissue grows in adjacent areas, for example two adjacent connecting areas 704, with such a thickness that the fibrotic tissues of each adjacent area meet and connect with each other over the distance or space between two elevated areas 701. In such a situation the space between two raised areas 701 may be partially or completely filled with the fibrotic tissue.

It may be advantageous that also a second distance 708b corresponding to the expansion of a downward area 702 has a fairly large expansion to prevent the fibrotic tissue from growing directly from a bonding area 704 to another bonding area 704. With the expression "growing directly from a bonding area 704 to another bonding area 704" this assumes that the fibrotic tissue grows from one binding area 704 to the other while not or only to a small degree that grows in an area down 702.

In Figure 69i a surface structure comprising raised and diminished areas has been shown, but apart from high and low areas also many other geometric structures can be used where it is possible to make the mentioned prevention of fibrotic tissue growth. In particular terms, the aforementioned prevention of fibrotic tissue growth between elevated areas and between connecting areas.

Some examples of such other geometric structures are shown in Figures 69i-69k. In a surface structure comprising edges and grooves, the edges and grooves may also have different sections, some examples are shown in Figures 69b-69e.

Referring mainly to Figures 69a and 69b some expressions and aspects will now be explained. In this application the concept of a first distance 708a, 718a between adjacent elevated areas 701, 710 is used. With such a first distance 708a, 718a this is assumed to be a distance that is substantially quantized from the edge 706, 714 of an elevated area 701, 710 to edge 706, 714 of a adjacent elevated area 701, 710. Substantially quantifying the edge means that the quantization can be carried out within a first range 704a of the level of an elevated area 701, 710, the first range 704a extending from the level of a raised area 701, 710 towards the level of an adjacent downward area 702, 712.

In this application the concept of a second distance 708b, 718b between adjacent connection areas 704, 716 is also used. With such a second distance 708b, 718b this assumes a distance that is substantially quantized from the connection point between a connection area .704, 716 and a downward area 702, 712 to another connection point involving an adjacent junction area 704, 716. Substantially quantifying the connection point means that the quantization can be carried out within a second interval 704b of the level from a downward area 702, 712, the second interval 704b extending from the level of an area downwards 702, to the level of an adjacent elevated area 701, 710.

With raised and low areas this is proposed areas that extend in different planes 703, 705, 720, 722 where the planes are separated by a distance 707, 724, 728. The planes may be parallel or substantially parallel, but may also be not parallel. If the planes are parallel, defining a distance between them It is trivial. If the plans are. not parallel (as in Figure 2a) a distance between the planes can be defined by about 724 normal, 728 to one of the planes 720, 722 where the normals extend to a point in one area in 722 other planes, 726 and the distance between the planes is equal to the expansion of the normal 724, 728. As seen in Figure 2a the normal 724, 728 extends from about 720 planes, 722 to a point that is approximately equally distant from the edges of an area. There are two possible ways to define the normal or distance between planes. Incorporating normal 728 as the example, one can define normal as in 728a or 728b. It may be appropriate to define the distance between two planes as the expansion of the longer normal, the distance between the planes 720 and 722 would then be equal to the expansion of the normal 728a. This definition will be used below.

The high and low areas may have different shapes, these may be flat or substantially flat but these may also have a kind of curved shape.

Elevated areas 701, 710 are connected to adjacent low areas 702, 712 by connecting areas 704, 716. Connection between raised / downward areas and connector areas 704, 716 may comprise a radius of different sizes, larger radii or More smalls. When the radius is very small there will be substantially edge 706, 714 union of the areas.

The expandable section of the expression implies that the section is also collapsible.

Suitably the implantable device 10 at least in part comprises materials having a high degree of biocompatibility, such materials can be called physiologically inert, biologically inert or biocompatible.

The reference particularly to Figures 69a-69b, in the surface structure 700 may advantageously be a first specified distance 708a, 718a between adjacent raised areas 701, 710. The distance between adjacent elevated areas 701, 710 is selected so that the fibrotic tissue can not be connected together on the first distance 708a, 718a between adjacent elevated areas 701, 710. Therefore, the first distance 708a, 718a between adjacent elevated areas 701, 710 is advantageously large enough to prevent the formation of the fibrotic tissue that connects each other on adjacent raised areas 701, 710.

As mentioned in the above, there may advantageously be a second specified distance 708b, 718b between adjacent connection areas 704, 716. The second distance 708b, 718b between adjacent connection areas 704, 716 is selected so that the fibrotic tissue can not connecting each other over the second distance 708b, 718b between adjacent connecting areas 704, 716. Therefore, the second distance 708b, 718b between adjacent connecting areas 704, 716 is advantageously large enough to prevent the formation of the fibrotic tissue that connects each other on adjacent connecting areas 704, 716.

It may also be advantageous that a third distance 707, 724, 728a between the different planes 703, 705, 720, 722, 726 of the raised and low areas are larger than a certain threshold to facilitate the collapsible and / or expandable functionality of the implant . If the third distance 707, 724, 728a is too small, the collapsible and / or expandable functionality of the implant can be limited. A suitable range for the third distance 707, 724, 728a is 0.5 to 10 mm, more suitable 2-8 mm and 3-7 mm more suitable. Also considering the aspect that the fibrotic tissue should not avoid the collapsible / expandable functionality of the implantable device it is advantageous that the distance 707, 724, 728a is not too small, but suitably in the range as mentioned previously.

The surface structure 700 may include lenses or elements of different geometric shapes, for example the edges of the different shapes, inlays of different shapes and other objectives that allow a surface structure as described here. The area of the raised areas 701, 710 may be very small while still resulting in a surface structure having the desired functionality. The area of the raised areas 701, 710 can even be almost zero, as exemplified in Figure 2d. While Figures 1A-1C and 2A-2D show cross sections of examples of surface structures 700, Figures 69i-69k show examples of the different 700 perspective on surface structures. The targets or elements in the surface structure 700 can be placed in rows, arranged in some other way, or they can be more or less randomly distributed over the surface of the implant. Different types of lenses can also be used together in the surface structure 700, for example, a combination of shaped pyramid and cone shaped objectives conformed with edges in some way.

In Figures 69f-69h an embodiment of an implant 10 is shown where a surface structure 700 is used, the implant 10 is not shown in its entirety. Figure 69f shows a longitudinal section of the implant 10 where 740 indicates the surface structure on the upper side of the implant 10 and 742 indicates the surface structure at the bottom of the implant 10. As shown in Figure 69f the surface structure 742 at the bottom may have a greater expansion than the surface structure 740 on the upper side of the penile prosthesis. This provides the implant 10 in bent position when the implant 10 is enlarged. The surface structures 140 and 142 are an example of a bending portion. Figure 69g shows a cross-section of the implant 10 where the implant 10 includes a waisted portion 744, wherein the waisted portion comprises waisted surface structures 746 and 748. The waisted portion with the waisted surface structures 746 and 748 makes the implant 10 expandable also in the radial direction. The implant 10 may also have a cross section as shown in Figure 69g 'comprising a waist portion 744 having four waist surface structures 750, 752, 754, 756 further facilitating the ability of the implant 10 to also be expandable. in the radial direction. The cross sections in Figures 69g and 69h are obtained along the line A1-A2 in Figure 69f.

Other embodiments comprise a stretching device.

Additional embodiments of the inventions that disclose the treatment of obesity by stretching the stomach are now described.

Figure 70a illustrates a stretch device 10 equipped with an inlet 18b. He Stretching device 10 invaginates into stomach wall 12 and inlet port 18b and is available for connection with a tube or the like of the abdominal area of the patient. The tube or conduit 18y can preferably be connected to the control unit 42y or an injection orifice lOOly.

Figure 70b illustrates an invaginated stretch device 10O where, instead of an inlet orifice, a conduit 18y or electrical cable extends into the abdominal area of the patient.

Figure 70c shows a section of the stretching device 10 and the part of the stomach where the stretching device 10 is invaginated. The conduit 18y or electric cable invaginates into the wall of the stomach 12 and by means of sutures or staples from stomach to stomach 14 and forms a completely sealed pouch of the stomach. Stomach wall tissue where the stretch device is placed. The conduit 18y or electric cable is thus dug into the wall of the stomach 12 and between the inlet 18b and the volume filling device 10Y.

This has shown that the shape of the stretch device 10 may incorporate many different shapes. It will be appreciated that also the material of the stretch device 10 may vary. It is preferred that the stretch device 10 is provided with a coating, such as Parylene, polytetrafluoroethylene (PTFE), or polyurethane coating, or a combination of such coatings, i.e., a multilayer coating. This multilayer coating or coating improves the properties of the stretching device, such as its resistance to wear.

In another embodiment shown in Figure 71, the stretching device 11Oy operates in accordance with a different principle of this described above with reference to Figures 65-70c. The stretching device 11Oy here comprises a first fixation portion HOay adapted to have a first fixation to a first position in the wall of the stomach 12 and a second fixation portion HOby adapted to have a second fixation to a second position in the wall of the stomach 12y These fixing portions 11Oay, by which they preferably have an essentially round shape and are preferably adapted to be invaginated in the stomach wall 12y, are fixed to the distal end of a respective leg 211y, which in turn is they fix their respective proximal end to an operating device, such as a motor 40y. According to the embodiment shown in Figure 71, the engine is a hydraulic motor, comprising a hydraulic piston, which is connected to a manually operated device previously described with reference to fig. 65. The hydraulic piston affects the legs through its connection with a hinge 212 and placed at the extremity of the leg. The IlOy stretching device is contained in a housing 214 and protects the device from growing into the fibrotic tissue which could potentially damage the function of the IlOy device. However, it is equally possible that the motor is another hydraulic motor, a pneumatic motor or an electric motor.

The IlOy stretching device is adapted to increase the distance between the first position and the second position in the stomach wall 12y, thereby stretching the stomach wall 12y. The first and / or second fixation portions 11Oay, HOby are adapted at least to be partially invaginated in the wall of the stomach 12 and with sutures or staples from stomach to stomach 14 and holding the fixation portions 11Oay, in place in the suspension with relation to the stomach wall 12y.

Of course, the first and second positions can be sutured or fixed to the stomach wall in many possible ways and the invention covers all possibilities of inflating the stomach wall by moving two portions of the stomach wall away from each other and thus first fixing the stomach. device for at least two positions in the wall of the stomach. However, soft suspended connection with the wall of the stomach 12 and where is preferred the Stomach tissue to fibrotic stomach helps to provide a stable long-term position.

Of course, just expanding an invaginated part of the stomach also stretches away from the wall of the stomach 12 and can also be achieved both mechanically, hydraulically, pneumatically and both driven with a motor or stepped on repeatedly or by manual force.

Any kind of mechanical construction can be used and the mechanical modality described is an example. Any mechanical construction activated by mechanically or hydraulically or any pneumatic construction can be used. Any motor or any pump or moving material that changes when driven can be used to achieve the simple objective of stretching a part of the stomach wall by moving at least two portions of the stomach wall away from each other.

Figure 72 shows the stretching device 11Oy according to a mode where the stretching device is controlled from an implantable control unit 42 and to which the sensor input, as described earlier, in the received one. The stretching device is then regulated through the conduit 18y using a pump 44y, connected for at least one fluid reservoir 16y, 46y, and driven from an energy transforming member 30 and connected to a receiver of the 205y wireless energy, placed under skin 36y, or an implantable power source 70y, such as a rechargeable electric battery.

In a variant, shown in Figure 73a, the first and / or second attachment portions 210a, 210b and 2b, respectively, show a structure adapted to be in contact with the stomach wall 12 and to promote the growth of human tissue to ensure placement long-term of the stretching device llOy attached to the stomach wall 12y. This structure preferably comprises a structure similar to network 213y. The attachment portions 210a, 210b and can be adapted to hold the stretching device 11Oy in place by sutures or staples between the fixation portion and the stomach wall 12y and to ensure short-term positioning of the stretch device 11Oy. In turns of the mechanical operation the stretching device 11Oy according to the embodiment shown in Fig. 73a operates in accordance with the device described with reference to fig. 71. Figure 9b shows a fixation device 213y comprising a network-like structure adapted to propagate the growth-in of the fibrotic tissue to fix the two attachment portions to the stomach wall 12y.

Figure 73c shows the stretching device according to the embodiment of fig. 73a in a second state., wherein the two fixation portions have been separated from each other and the stomach 12 and has been stretched.

Figure 74a shows the stretching device according to an embodiment wherein the stretching device is an electrical mechanical stretching device connected to a control unit 42 and through an energy supply line 32 'and. The power supply line 32y is connected to a power transformer device 30 and in contact with a wireless power receiver 205y, such as a coil, which receives the power from a transmitter of the wireless power 34ay. The control unit may further comprise an electrical battery 70y for storing the energy received from the wireless power transmission device 34ay. The control unit receives the input of a sensor 201y, which according to this modality is a stretching meter that measures the contraction and / or relaxation of the cardia 204y.

Figure 74b shows the stretching device lOy in greater detail. The stretch device 10 comprises a housing having a bellows structure 20 and making it of a flexible material to allow portions of the wall to move. The power supply line 32y is connected to a stator 217 and an electric motor, the motor further comprising a rotor 218y comprising a thread that interacts with a displaceable member 219y and comprising a corresponding thread. The displacement member is rotatably fixed to a housing engaging member 220 and urging against the housing to affect the volume of the stretching device and thus stretch the stomach 12y.

Figure 74c shows the stretching device Figure 10B according to a second condition, wherein the stretching device expands and consequently stretches the stomach wall 12y.

Figure 75a shows a mode where a device adapted to treat the reflux disease is combined with the stretching device according to any of the above modalities. After the invagination of device 410 in fundus 416, a fixation comprising several sutures or staples from stomach to stomach 422a is applied to keep invagination intact in the short term. A second fastener comprising several sutures or staples 422b is provided to hold the device 410 in position above the cardia 414. The sutures or staples 422b are applied between the wall of the fundus 416 and the wall of the esophagus 424y. In addition, a third fixation in the form of sutures or staples 422cy can be provided between the wall of the fundus 416 and the diaphragm 418, again, to maintain the position of device 410 greater than cardia 414.

In this fourth embodiment shown in Figure 75a, the size of the reflux disease treatment device 410 can be regulated by being implanted. The reflux disease treatment device 410 is associated with a subcutaneous hydraulic reservoir 452 connected to the reflux disease treatment device 410, by a cable 452b whereby a non-invasive regulation can be carried out by manually pressing the reservoir 452. Pressing the reservoir 452 displaces the hydraulic fluid from the reservoir 452 to the smaller chambers 410b through the cable 452b. The reflux disease treatment device 410, in turn, is connected to one or more smaller chambers 410b. In this way, the patient can adjust the size of the reflux treatment device 410 adapted to the treatment.

Additionally, the above modality can alternatively be used to treat obesity. The device, in this embodiment, can be adapted to treat obesity by using the volume of the reflux disease body to contain a fluid, and additionally using one or more smaller chambers 410b connected to the device body with a pump to fill with the body. fluid to multiply and thus stretch the fundus wall to create satiety. The small chambers 410b are also adapted to be invaginated in the fundus wall of the stomach, and when filled with the fluid, an expansion of the stomach occurs which results in the feedback of the human sensor creating satiety. The reservoir / subcutaneous hydraulic pump allows the patient to conveniently pump the hydraulic fluid to fill the small chambers 410b to form a feeling of fullness as he or she wishes.

An alternative modality is shown in the Figure 75b. This embodiment is substantially similar to that shown in Figure 75a, but differs in how the reflux treatment device 410 and chambers 410b is controlled. Here, the cameras 410b are not controlled by a subcutaneous pump, but an internal control unit 456 operates. The internal control unit 456 comprises means for the patient to control the device 410 on how it will be used with reference to the reflux treatment and / or obesity. This may also comprise means for supplying energy with the device.

The internal control unit 456 may comprise an electric battery 470, an electrical switch 472, a motor / pump 444, a reservoir 452, and an injection port 1001. A power transmission device 34 with a remote control is adapted to control the drive of device. The items that are selected according to the circumstances, for example if the device is electrically, hydraulically, pneumatically or mechanically operated. The device 410 can be used to maintain electronic components and / or a power source and / or hydraulic fluid.

Figure 76a shows an adjustable volume filling device 810y, which invaginates in the stomach wall of a patient's stomach 12y. The volume filling device 810y adapts to ingest space in the stomach and thus reduce the volume where food can be placed. In addition, an adjustable stretch device 10O according to any of the modalities invaginates in the fundus wall of the patient's stomach. It is preferred that the volume filler device 810y be substantially larger than the stretch device 10Y.

The volume filling device 810 and the stretching device 10Y are in fluid communication with each other through a first fluid tube 52y, wherein a pump 54y is provided. The pump 54y is under the control of a power transformer device 30y, which is adapted to supply the pump 54and the power through a power supply line 56. The power transformer device 30 is also connected with a sensor 201y provided in the patient's esophagus so that food intake can be detected.

The volume filling device 810 and the stretching device 10y are also in fluid communication with each other through a second fluid tube 58y, which preferably has a smaller cross-sectional area than the first fluid tube 52y.

The operation of this arrangement is as follows. The volume filling device 810y functions as in the previously described embodiments, that is, it reduces the size of the food cavity of the patient's stomach 12y. Further, when the stretching device 10O is enlarged by pumping the fluid from the volume filling device 810y to the stretching device 10y by the pump means 54y, the fundus wall of the stomach is stretched, creating a feeling of satiety for the patient. In this way, for example when the food intake is detected by means of the sensor 201y, the fluid is automatically pumped into the stretching device 10 and that they increase the feeling of satiety and thus limit the intake of food.

When the fluid has been injected into the stretch device 10Y, the internal pressure in that part is higher than the internal pressure in the volume filling device 810y. This difference in pressure will form a fluid flow in the second, preferably narrower tube 58 and of the stretching device 10 to the volume filling device 810y. The flow rate will be determined by, among other things, the difference in pressure and the cross-sectional area of the second tube 58y. It is preferred that the second tube is thus dimensioned, that the pressures in the volume filling device 810 and the stretching device 10Y will be returned to equilibrium after 3 hours after the fluid has been injected into the stretching device 10Y to form the feeling of satiety.

In this embodiment, the function of the second tube 58y is to allow the fluid to return from the stretching device 10y to the volume filling device 810y. It will be appreciated that this function can also be performed by the pump 54 and in the first tube 52 and that the second tube 58 and then can be omitted.

Still an alternative embodiment of an apparatus for treating obesity will now be described with reference to Figure 76b, which shows a stomach 12 and a patient undergoing treatment for obesity. The apparatus comprises a volume filling device 810y in the form of an inflatable device 10O which invaginates in the wall 12a of the patient's stomach 12y. However, in this case the intussusception has taken place in the fundus, say, the upper portion of the stomach, where the number of receptors in the wall of the stomach is greatest, and the inflatable device functions as a stretching device for the part of the fundus wall of the stomach.

A regulation reservoir for fluids is connected to the inflatable device by means of a conduit 18 and in the form of a tube. The inflatable device 810y is thus adapted to be regulated, preferably non-invasively, by fluid in motion or air from the regulating tank to the chamber formed by the inflatable device 810y. The regulation of the inflatable device 810y preferably comprises a reverse servomechanism, that is, a small volume is actuated for example by the patient's finger and this small volume is in relation to a larger volume, that is to say, the regulating reservoir.

Thus, the inflatable device 810y is placed outside the stomach wall and is adapted to stretch a part of the fundus wall of the stomach, thereby affecting the patient's appetite. By enlarging the size of the stretching device, the fundus wall of the stomach surrounding the inflatable stretching device 810y is stretched since the circumference of the inflatable stretching device 810y is increased. By this stretch, the receptors in the wall of the stomach They indicate that the stomach is complete, thus creating a feeling of fullness to the patient. Proportionally, when the 810y stretching device contracts, the receptors indicate that the stomach is not full, thus returning the feeling of hunger. It will be appreciated that this embodiment combines the effects of both reducing the volume of the stomach food cavity and stretching the part of the stomach wall 12y, thereby increasing the treatment effect.

The expansion and contraction of the 810y stretching device can be carried out under the direct control of the patient. Alternatively, the expansion and contraction can be carried out according to a pre-programmed program.

In a preferred embodiment, shown in the Figure 76c, a sensor 201y is provided to a suitable position, such as to the esophagus. The volume filling device 810y in the form of the inflatable stretching device is similar to that shown in Figure 76b. By providing one or more sensors, the apparatus for treating obesity can be automated in that the size of the volume filling device 810y in the form of the inflatable stretching device is adjusted according to the amount of food entering the alimentary cavity of the stomach. The fluid is thus moved between the volume filling device 810 inflatable and a fluid reservoir.

System An obesity treatment system that can be combined with the system above to treat reflux, generally designated 28 and comprising a stretching device as described above will now be described with reference to Figures 77-93. System 28 may be combined with or be the same as system 28 for treating reflux in Figures 1A-64.

The system of Figure 77 comprises a stretch device 10 placed on the abdomen of the patient. An internal power source in the form of an implanted power transformer device 30 is adapted to supply energy consuming components of the obesity treatment system with energy through an energy supply line 32. A power transmission device External 34 includes a wireless remote control that transmits a wireless signal, which is received by a signal receiver, which may be incorporated into the implanted power transformer device 30 or separated therefrom. The implanted power transforming device 30 transforms the energy of the signal into the electrical energy that is supplied through the power supply line 32.

The system of Figure 77 is shown in the form of more generalized block diagram in Figure 79, where the patient's skin 36, generally shown by a vertical line, separates the inner part of the patient to the right of the line from the outside to the left of the line.

Figure 77 shows a simplified block diagram showing the stretch device 10O, the power transformer device 30 driving the stretching device through power supply line 32, and the external power transmission device 34.

Figure 78 shows an embodiment of the invention identical to that of Figure 81, except that a device that reverses in the form of an electrical switch 38 operable by the polarized energy is also implanted in the patient to reverse the stretch device. . The wireless remote control of the external power transmission device 34 transmits a wireless signal that transports the polarized energy and the implanted power transformer device 30 transforms the polarized radio energy into a polarized current to operate the electrical switch 38. When the polarity of the the current is displaced by the implanted power transformer device 30 the electric switch 38 reverses the function carried out by the stretch device 10Y.

Figure 79 shows an embodiment of the invention identical to that of Figure 78, except that an operating device 40 implanted in the patient for regulating the stretching device 10Y is provided between the implanted power transforming device 30 and the stretching device. lOy. This operating device can be in the form of about 40 motor, like an electric servomotor. The motor 40 is driven by the energy of the implanted power transformer device 30, since the remote control of the external power transmission device 34 transmits a wireless signal to the receiver of the implanted power transformer device 30.

Figure 80 shows an embodiment of the invention identical to that of Figure 81, except that this also comprises an operating device in the form of a unit 42 that includes a motor / pump unit 78 and a fluid reservoir 46 is implanted in the patient. In this case the stretching device 10Y is hydraulically operated, i.e. the hydraulic fluid is pumped by the motor / pump unit 44 of the fluid reservoir 46 through a conduit 48 to the stretching device 10O to operate the stretching device, and the hydraulic fluid is pumped by the motor / pump unit 44 again from the stretch device 10 to the tank of fluid 46 to return the stretching device to an initial position. The implanted power transforming device 30 transforms the wireless energy into a current, for example a polarized current, to drive the motor / pump unit 44 through an electric power supply line 50.

Instead of a hydraulically operated stretching device 10y, it is also envisioned that the operating device comprises a pneumatic operating device. In this case, the pressurized air can be used for regulation and the fluid reservoir is replaced by an air chamber and the fluid is replaced by air.

In all these embodiments, the power transformer device 30 may include a rechargeable accumulator such as an electrical battery or a capacitor to be charged by the wireless energy and supplies the power to any energy consuming part of the device.

The external power transmission device 34 is preferably the radio and may include a remotely controlled control device for controlling the device from outside the human body.

Such a control device may include a wireless remote control as well as manual control of any part implanted to make contact with patients gives with the greater indirect probability for example a button to press placed under the skin.

Figure 81 shows an embodiment of the invention comprising the external energy transmission device 34 with its wireless remote control, the stretching device 10Oy, in this case hydraulically operated, and the implanted power transforming device 30, and additionally comprising a hydraulic fluid reservoir 52, a motor / pump unit 44 and a reversing device in the form of a hydraulic valve changing device 54, all implanted in the patient. Of course the hydraulic operation could be easily carried out by changing only the direction that is stepped on repeatedly and the hydraulic valve can therefore be omitted. The remote control can be a device separate from the external power transmission or included in it. The engine of the motor / pump unit 44 is an electric motor. In response to a control signal from the wireless remote control of the external power transmission device 34, the implanted power transformer device 30 drives the motor / pump unit 44 with the energy of the energy carried by the control signal, so which the motor / pump unit 44 distributes the hydraulic fluid between the hydraulic fluid reservoir 52 and the Stretching device lOy. The remote control of the external power transmission device 34 controls the hydraulic valve changing device 54 to displace the hydraulic fluid flow direction between a direction where the fluid is pumped by the motor / pump unit 44 of the hydraulic fluid reservoir 52 to the stretching device 10 to operate the stretching device, and another opposite direction where the fluid is pumped by the motor / pump unit 44 again from the stretching device 10 to the hydraulic fluid reservoir 52 to return the stretching device to a initial position.

Figure 82 shows an embodiment of the invention identical to that of Figure 81, except that an internal control unit 56 controlled by the wireless remote control of the external power transmission device 34, an accumulator 58 and a capacitor 60 is also implanted in the patient. The internal control unit 56 configures the storage of the electric energy received from the implanted energy that transforms the device 30 into the accumulator 58, which supplies the power to the stretching device 10Y. In response to a control signal of the wireless remote control of the external energy transmission device 34, the internal control unit 56- electrical energy of releases of the accumulator 58 and transformations the energy released through power lines 62 and 64, or directly transforms the electrical energy of the implanted power transformer device 30 through a power line 66, the capacitor 60, which stabilizes the electric current, a power line 68 and the power line 64, for the operation of the stretch device 10Oy.

The internal control unit is preferably programmable from outside the body of a patient. In a preferred embodiment, the internal control unit is programmed to regulate the stretching device 10 to stretch the stomach according to a program of the pre-programmed time period or to introduce any sensor that detects any possible physical parameter of the patient or any functional parameter of the device.

According to an alternative, the capacitor 60 in the embodiment of Figure 18 can be omitted. According to another alternative, the accumulator 58 in this mode can be omitted.

Figure 83 shows an embodiment of the invention identical to that of Figure 77, except that an electric battery 70 for supplying the power for the operation of the stretching device 10 and an electrical switch 72 for switching the operation of the Stretch 10 and is also implanted in the patient. The electrical switch 72 is operated by the energy supplied by the implanted power transformer device 30 to the switch of a shutdown mode, where the electrical battery 70 is not in use, to an ignition mode, wherein the electrical battery 70 supplies power for the operation of the stretch device lOy.

Figure 84 shows an embodiment of the invention identical to that of Figure 83, except that an internal control unit 56 controllable by the wireless remote control of the external energy transmission device 34 is also implanted in the patient. In this case, the electrical switch 72 is operated by the power supplied by the implanted power transformer device 30 for switching from a shutdown mode, wherein the wireless remote control is prevented from controlling the internal control unit 56 and the Electric battery is not in use, to a standby mode, wherein the remote control is allowed to control the internal control unit 56 to release electrical power from the electric battery 70 for the operation of the stretch device 10Y.

Figure 85 shows an embodiment of the invention identical to that of Figure 84, except that an accumulator 58 is replaced for the electric battery 70 and the implanted components are interconnected differently. In this case, the accumulator 58 stores the energy of the implanted power transformer device 30. In response to a control signal of the wireless remote control of the external power transmission device 34, the internal control unit 56 controls the electrical switch 72 for switching from off mode, where the accumulator 58 is not in use, to an ignition mode, wherein the accumulator 58 supplies the energy for the operation of the stretch device 10Y.

Figure 86 shows an embodiment of the invention identical to aguella of Figure 85, except that an electric battery 70 is also implanted in the patient and the implanted components are interconnected differently. In response to a control signal from the wireless remote control of the external power transmission device 34, the internal control unit 56 controls the accumulator 58 to provide power to operate the electrical switch 72 to change the shutdown mode, wherein the electric battery 70 is not in use, to one in ignition mode, wherein electric battery 70 supplies electric power for the operation of the stretch device lOy.

Alternatively, the electrical switch 72 can be operated by the energy supplied by the accumulator 58 for switching from a power off mode, wherein the wireless remote control is prevented from controlling the electric battery 70 to supply the electrical power and is not in use, to a standby mode, wherein the wireless remote control is allowed to control the electric battery 70 for supplying electric power for the operation of the stretch device 10Oy.

It must be understood that the switch must be considered in its broadest form. These means an FPGA or a DA converter or any other electronic component or circuit can activate the power and shutdown preferably by controlling it from outside the body or by means of an internal control unit.

Figure 87 shows an embodiment of the invention identical to that of Figure 83, except that about 40 of the engine, a mechanical reversing device in the form of a gearbox 74, and an internal control unit 56 for controlling the gearbox. Changes 74 are also implanted in the patient. The internal control unit 56 controls the gearbox 74 to reverse the function carried out by the stretch device 10O (mechanically operated). Even simpler should change the direction of the motor electronically.

Figure 88 shows an embodiment of the invention identical to that of Figure 86 except that the implanted components are interconnected differently. In this way, in this case the internal control unit 56 is driven by the electric battery 70 when the accumulator 58, suitably a capacitor, activates the electrical switch 72 to change to an ignition mode. When the electrical switch 72 is in its in mode the internal control unit 56 is allowed to control the electric battery 70 to supply, or not to supply, energy for the operation of the stretching device 10Y.

Figure 89 schematically shows conceivable combinations of implanted components of the apparatus to achieve various communication options. Basically, there is a lyoy stretching device, the internal control unit 56, motor or pump unit 44, and the external power transmission device 34 that includes the external wireless remote control. As already described above, the wireless remote transmits a control signal that is received by the internal control unit 56, which in turn controls various implanted components of the apparatus.

A feedback device, preferably in the form of a sensor 76, can be implanted in the patient to detect a physical parameter of the patient, such as a contraction wave in the esophagus that 203 informs that the patient is eating. The internal control unit 56, or alternatively the external wireless remote control of the external power transmission device 34, can control the stretching device 10y in response to signals from the sensor 76. A transceiver can be combined with the sensor 76 to send the information about the perceived physical parameter to the external wireless remote control. The wireless remote control may comprise a signal transmitter or transceiver and the internal control unit 56 may comprise a signal receiver or transceiver. Alternatively, the wireless remote control may comprise a signal receiver or transceiver and the internal control unit 56 may comprise a signal transmitter or transceiver. The above transceivers, transmitters and receivers can be used to send the information or data related to the IO stretch device from inside the patient's body to the outside thereof.

Alternatively, the sensor 76 may be configured to detect a functional parameter of the stretch device 10Y.

Where the motor / pump unit 44 and electric battery 70 are implanted to drive the motor / pump unit 44, the electric battery 70 can be equipped with a transceiver to send the information about the condition of the electric battery 70. Be more precise, when charging with an electric battery or accumulator with the energy feedback information related to charging that the process is sent and the power supply is changed accordingly.

Figure 90 shows an alternative embodiment where the IOy stretching device is regulated from outside the body of a patient. The obesity treatment system 28 comprises an IO stretching device connected to an electric battery 70 via a subcutaneous switch 80. In this way, the regulation of the IO stretch device is carried out non-invasively by manually pressing the subcutaneous switch. , whereby the operation of the stretch device 10 turns on and off. It will be appreciated that the embodiment shown is a simplification and that additional components, such as an internal control unit or any other part described in the present application may be added to the obesity treatment system.

Figure 91 shows an alternative embodiment, wherein the obesity treatment system 28 comprises an IO stretching device in fluid connection with a hydraulic fluid reservoir 52. The non-invasive regulation is carried out by manually pressing the hydraulic reservoir connected to the Stretching device lOy.

Another embodiment of a system according to the invention comprises a backflush device for sending information from inside a patient's body to the outside thereof to provide feedback information related to at least one functional parameter of the stretching device or system or a physical parameter of the patient, thus optimizing the performance of the system.

In Figure 92, an arrangement for delivering an exact amount of energy to an obesity treatment system 28 implanted in a patient, whose skin 36 is indicated by a vertical line, is schematically illustrated. An IO stretching device is connected to an implanted energy transforming device 30, also located inside the patient, preferably only under the patient's skin 36. In general terms, the implanted power transforming device 30 can be placed in the abdomen, thorax, muscular fascia (for example in the abdominal wall), subcutaneously, or any other suitable location. The implanted power transformer device 30 is adapted to receive wireless E energy transmitted from an external power source | 34a provided in the external energy transmission device 34 located outside the patient's skin 36 in the vicinity of the implanted power transformer device 30.

As is known in the art, wireless energy E can be transferred in general by means of any suitable Subcutaneous Energy Transfer (TET) device, such as a device that includes a primary coil configured in external power source 34a and a secondary coil adjacent one configured in the implanted power transformer device 30. When an electric current is fed through the primary coil, the energy in the form of a voltage is induced in the secondary coil that can be used to operate a stretch device, by example after storing the input energy in an energy storage device or accumulator, such as an electric battery or a capacitor. However, the present invention is not generally limited to any particular energy transfer technique, TET devices or energy storage devices, and any kind of wireless energy can be used.

The amount of internal energy received within the body to the device can be compared to the energy used by the device. It is understood then that the term used by the device also includes the energy stored by the device. The amount of energy transferred can be regulated by means of an external control unit 34b control of the external power source 34a based on the determined energy balance, as described above. In order to transfer the correct amount of energy, the energy balance and the required amount of energy can be determined by means of an internal control unit 56 connected to the stretching device 10Y. The internal control unit 56 can thus be configured to receive various measurements obtained by suitable sensors or the like, not shown, quantifying certain characteristics of the stretch device 10, in some way reflecting the required amount of energy necessary for the proper functioning of the Stretching device lOy. Moreover, the current state of the patient can also be detected by means of suitable measuring devices or sensors, in order to provide parameters that reflect the condition of patients. Therefore, such characteristics and / or parameters can be related to the current state of the stretch device 10, such as power consumption, operational mode and temperature, as well as the condition of patients reflected by, for example, body temperature, blood pressure, heartbeat and breathing.

Additionally, an energy storage device or accumulator 58 may optionally be connected to the implanted power transformer device 30 to accumulate the energy received for later use by the stretch device 10Y. Alternatively or in addition, the characteristics of such an accumulator, also reflecting the required amount of energy, can also be quantified. The accumulator can be replaced by an electric battery, and the quantized characteristics can be related to the current state of the electric battery, such as voltage, temperature, etc. In order to provide sufficient and current voltage to the stretch device 10, and also to avoid excessive heating, it is clearly understood that the electric battery should be optimally charged by receiving a correct amount of energy from the implanted power transforming device 30, i.e. too little or too much. The accumulator can also be a capacitor with corresponding characteristics.

For example, the characteristics of the electric battery can be quantified regularly to determine the current state of the electric battery, which can then be stored as the state information in a suitable storage means in the internal control unit 56. In this way, provided that the new measurements are elaborate, the stored battery status information can be updated accordingly. In this way, the status of the electric battery can be calibrated by transferring a correct amount of energy, to keep the electric battery in an optimal condition.

Thus, the internal control unit 56 is adapted to determine the energy balance and / or the currently required amount of energy, (energy per unit time or accumulated energy) based on measurements made by the sensors previously or measurement devices in the stretch device 10, or the patient, or an energy storage device to be used, or any combination thereof. The internal control unit 56 is additionally connected with. an internal signal transmitter 82, configured to transmit a control signal that reflects the determined required amount of the energy, to an external signal receiver 34c connected to the external control unit 34b. The amount of energy transmitted from the external power source 34a can then be regulated in response to the received control signal.

Alternatively, the sensor measurements can be transmitted directly to the external control unit 34b where the energy balance 'and / or the currently required amount of the energy can be determined by the external control unit 34b, thus integrating the function previously described of the internal control unit 56 in the external control unit 34b. In this case, the internal control unit 56 can be omitted and the sensor measurements are supplied directly to the internal signal transmitter 82 which sends the measurements to the external signal receiver 34c and the external control unit 34b. The energy balance and the currently required amount of energy can then be determined by the external control unit 34b based on those sensor measurements.

Therefore, the present solution employs the feedback of the information indicating the required energy, which is more efficient than previous solutions because this is based on the current use of the energy that is compared to the received energy, for example with respect to the amount of energy, the difference in energy, or the rate of energy reception compared to the rate of energy used by the stretching device. The stretching device may use the energy received for the consummation or to store the energy in an energy storage device or the like. The different parameters analyzed above would be used if relevant and necessary and then as a tool to determine the current energy balance. However, such parameters may also be necessary per se for any action internally incorporated to operate specifically the stretching device.

The internal signal transmitter 82 and the external signal receiver 34c can be implemented since separate units using the appropriate signal transfer media, such as radio, IR (Infrared) or ultrasonic signals. Alternatively, the internal signal transmitter 82 and the external signal receiver 34c may be integrated into the implanted power transformer device 30 and the external power source 34a, respectively, to communicate control signals in a reverse direction relative to the transfer of energy, basically using the same transmission method. The control signals can be modulated with respect to frequency, phase or amplitude.

To conclude, the power supply configuration illustrated in Figure 28 can operate basically in the manner that follows. The energy balance is determined first by the internal control unit 56. A control signal that reflects the required amount of energy is also formed by the internal control unit 56, and the control signal is transmitted from the internal signal transmitter 82 to the external signal receiver 34c. Alternatively, the energy balance can be determined by the external control unit 34b instead in accordance with the embodiment, as above. In this case, the signal. Control can carry results from quantification of various sensors. The amount of energy emitted from the external power source 34a can then be regulated by the external control unit 34b, based on the determined energy balance, for example in response to the received control signal. This process may be repeated intermittently at certain intervals during the current energy transfer, or may be running on a more or less continuous basis during the energy transfer.

The amount of the transferred energy can be regulated in general by adjusting various transmission parameters in the external power source 34a, such as voltage, current, amplitude, wave frequency and pulse characteristics.

One method is thus provided to control the transmission of the wireless energy supplied to an electrically operable stretching device implanted in a patient. The wireless energy E is transmitted from an external power source located outside the patient and is received by an internal energy receiver located inside the patient, the internal energy receiver that is connected to the stretching device to directly or indirectly supply the received energy the same. An energy balance is determined between the energy received by the internal energy receiver and the energy used for the stretching device. The transmission of the wireless energy E from the external power source is then controlled based on the determined energy balance.

A system for controlling the transmission of the wireless energy supplied to an electrically operable stretching device implanted in a patient is also provided. The system is adapted to transmit the wireless energy E from an external power source located outside the patient that is received by an implanted power transformer device located within the patient, the implanted power transformer device which is connected to the stretching device to supply directly or indirectly the energy received to it. The system is further adapted to determine an energy balance between the energy received by the implanted power transformer device and the energy used for the stretching device, and to control the transmission of the wireless energy E from the external power source, based on the energy balance determined.

In yet an alternative mode, the external source of energy is controlled from outside a patient's body to release the electromagnetic wireless energy, and released electromagnetic wireless energy is used to operate the stretching device.

In another embodiment, the external power source controls from outside the body of a patient to release the non-magnetic wireless energy, and the non-magnetic wireless energy released is used to operate the stretching device.

Those skilled in the art will understand that various prior embodiments according to Figures 17-29 could be combined in many different ways. For example, the polarized energy operated electric switch 38 could be incorporated in any of the embodiments of Figures 11, 18-24, the hydraulic valve changing device 54 could be incorporated in the embodiment of Figure 16, and the gearbox 74 it could be incorporated in the modality of Figure 15. It should be noted that the switch could simply mean any electronic circuit or component.

The wireless transfer of energy to operate the stretching device has been described to allow non-invasive operation. It will be appreciated that the Stretching device can be operated with the wire the energy attached too. One such example is shown in Figure 93, where an external switch 84 is interconnected between the external power source 34a and an operating device, such as an electric motor that regulates the stretch device 10Y, by means of power lines 86. and 88. An external control unit 34b controls the operation of the external switch to effect proper operation of the stretch device 10Y.

Hydraulic or pneumatic drive Figures 94-97 show in more detail block diagrams of four different modes of hydraulically or pneumatically actuation an apparatus for treating obesity according to the invention.

Figure 94 shows an apparatus for treating obesity as described above with reference to any of Figures 65-70c. The apparatus comprises a stretching device 10 and additionally a separate regulating tank 16, a one way pump 44 and an alternating valve 54.

Figure 95 shows the stretching device 10 and a fluid reservoir 16. By moving the wall of the regulating reservoir or changing the size thereof in any other different mode, the adjustment of the stretching device can be carried out without no valve, through only free of fluid any period of time by movement the tank wall.

Figure 96 shows the stretching device 10, a two-way pump 44 and the regulating tank 16.

Figure 97 shows a block diagram of a reverse servomechanism system with a first closed system that controls a second closed system. The servomechanism system comprises a regulating tank 16 and a servomechanism tank 90. The servo-tank 90 mechanically controls a stretching device 10 through a mechanical interconnection 94, the stretching device having an expandable / contactable cavity. This cavity is preferably multiplied or contracted by supplying the hydraulic fluid of the largest adjustable reservoir 92 in fluid connection with the stretching device 10Y. Alternatively, the cavity contains the compressible gas, which can be compressed and expanded under the control of the servomechanism tank 90.

The servomechanism reservoir 90 can also be part of the stretching device itself.

In one embodiment, the regulating reservoir is placed subcutaneously under the patient's skin 36 and is operated by pushing the external surface thereof by means of a finger. This obesity treatment system is illustrated in Figures 98a-98c. In Figure 98a, a flexible subcutaneous regulating reservoir 16 is shown connected with a bulging servo tank 90 by means of a conduit 18. This bellows-shaped servomechanism reservoir 90 is comprised in a flexible stretch device 10Y. In the state shown in Figure 98a, the servomechanism tank 90 contains minimal fluid and most fluid is in the regulating tank 16. Due to the mechanical interconnection between the servomechanism tank 90 and the stretch device 10 , the external shape of the stretching device 10 is contracted, that is, it occupies less than its maximum volume. This maximum volume is shown with dashed lines in Figure 98a.

Figure 98b shows a state where a user, as the patient in with the stretching device is implanted, presses the regulation reservoir 16 so that the fluid contained in that part is set to flow through the conduit 18 and into the reservoir of servomechanism 90, which, thanks to its bellows shape, is extended longitudinally. This expansion in turn multiplies the stretching device 10 so that this occupies its maximum volume, thereby stretching the stomach wall (not shown) with which it is brought into contact.

The regulating tank 16 is provided preferably with means to maintain its shape after compression. These means, which are schematically shown as 16a in Fig. 98c, will thus keep the stretching device 10 in a stretched position also when the user releases the regulating tank. In this way, the regulation reservoir functions essentially as a switch for the obesity treatment system.

An alternative embodiment of the hydraulic or pneumatic operation will now be described with reference to Figures 99 and 100a-100c. The block diagram shown in Figure 99 comprises a first closed system controlling a second closed system. The first system comprises a regulating tank 16 and a servomechanism tank 90. The servo tank 90 mechanically controls a larger adjustable tank 92 through a mechanical interconnection 9. An IO stretching device having an expandable / contactable cavity is in turn controlled by the larger adjustable reservoir 92 by the hydraulic fluid supply from the larger adjustable reservoir 92 in fluid connection with the stretch device 10Y.

An example of this embodiment will now be described with reference to Figure 100a-100c. As in the previous modality, the regulation reservoir is placed subcutaneously under the skin of the patient and is operated by pushing the external surface of the same by means of a finger. The regulating tank 16 is in fluid connection with a bellows the shaped servomechanism tank 90 by means of a conduit 18. In the first closed system 16, 18, 90 shown in Figure 34a, the servomechanism tank 90 contains a minimum of fluid and most of the fluid is in the regulating tank 16.

The servomechanism tank 90 is mechanically connected to a larger adjustable reservoir 92, in this example also having a bellows shape, but with a larger diameter than the servo tank 90. The larger adjustable reservoir 92 is in fluid connection with the stretching device lOy. This means that when a user pushes the regulating tank 16, thus displacing the fluid from the regulating tank 16 to the servo tank 90, the expansion of the servo tank 90 will displace a larger volume of fluid from the larger adjustable reservoir 92 to the control device. IO stretch. In other words, in this reverse servomechanism, a small volume in the regulation reservoir is compressed with a higher force and this forms a movement of a larger total area with less force per unit area.

As in the above embodiment described above with reference to Figures 98a-98c, the adjustment tank 16 is preferably provided with means for maintaining its shape after compression. These means, which are schematically shown as 16a in the figure, will thus keep the stretching device 10 in a stretched position also when the user releases the regulating tank. In this way, the regulation reservoir functions essentially as a switch for the obesity treatment system.

Method for the surgical treatment of a patient suffering from reflux and obesity A method for surgically treating an obese patient also suffering from reflux, the method comprising the steps of cutting an opening in the patient's abdominal wall, dissecting an area around the stomach, placing an apparatus to treat a part of the patient's wall. stomach of the patient, and suture the wall of the stomach.

The apparatus for treating obesity and reflux is preferably placed in a patient through a laparoscopic abdominal procedure, comprising the steps of inserting a needle or tube as the instrument into the abdomen of a patient's body, using the needle or a tube like the instrument to fill the abdomen of patient with the gas that thus multiplies the patients abdominal cavity, placing at least two laparoscopic trocars in the body of a patient, inserting a camera through one of laparoscopic trocars in the abdomen of the patient, inserting at least one tool dissection through one of s at least two laparoscopic trocars and dissect an area of intended placement of the patient, and placement of an apparatus to treat obesity in relation to the wall of the "stomach.

The methods could further comprise the step of post-functionally regulating the at least one stretching device for: stretching a portion of the stomach wall and regulating the stretching device from outside the body of a patient to affect the patient's appetite.

Instruments An intraluminal method to invaginate a stretching device 10 outside the stomach wall 12 will now be described with reference to Figures 101a-101i. Initially, an instrument 600, preferably a gastroscopic instrument, is inserted into the patient's mouth, see Figure 101a. The instrument comprises an injection device 601, 602 for injecting the fluid or a device into the patient's stomach. He instrument 600 further comprises a control unit 606 adapted to control the operation of the instrument. To this end, the control unit 606 comprises one or more steering devices, in the embodiment shown in Fig. 101a in the form of two control levers 603 and two control buttons 604. A display 605 is provided for the demonstration of the image provided by an optical device for observing inside the stomach, as a camera (not shown) configured to the outer end of the elongate member 607, see Figures 101e-101i. The chamber, which may comprise electrical wires connecting and extending along the elongated member, may be helped by a light source (not shown) positioned distally on the elongated member to illuminate the interior of the stomach. The optical device may also comprise optical fibers positioned along the elongated member and leading to the body of a patient for external inspection of the interior of the stomach.

The instrument is additionally inserted into the esophagus and into the patient's stomach, see Figure 101b. By means of the instrument 600, a hole 12b is formed in the stomach wall 12y. To this end, the instrument is provided with one or more cutters 615 at the distal end thereof. These cutters can of course be designed in different ways, like a drum cutter Toothed that rotates on the central axis of the instrument similar to a tube.

After a hole is cut in the wall of the stomach, the distal end of the instrument 600 is inserted into and through the hole 2by so that it ends outside the stomach wall 12a. This is shown in Figure 101c, showing a side view of stomach 12y, and Figure lOld, which is a sectional view through the stomach of Figure 101c incorporated along lines Vd Vd.

The instrument 600 is adapted to form a cavity or sachet outside the stomach around the hole 12b and in the stomach wall 12y. Such an instrument and the method for providing the sachet will now be described.

Figures 101e-101i show a gastroscopic or laparoscopic instrument to invaginate a stretching device 10 in the wall of the patient's stomach 12 creating a sachet in the stomach wall 12 where the stretching device 10 is placed. The instrument, in general designated 600, comprises an elongate member 607 having a proximal end and a distal end, the elongated member 607 having a smaller diameter than that of the patient's esophagus and being flexible such as to allow introduction of the elongate flexible member 607 with its distant end first through the narrowing of patients, esophagus and in the stomach 12 to the stomach wall 12a.

The stomach penetration device or the cutter 615 is provided in the elongated member 607 at a distance thereto to penetrate the stomach wall 12a to form a hole in the stomach wall 12a, to allow the elongate member 607 to be introduced through the stomach. orifice. The stomach penetration device 615 could be adapted to be operable to retract the stomach penetration device 615 after the fundus wall of the stomach 12a has been penetrated, for additionally non-woven damage within the body. The instrument further comprises a special holding device 609 provided on the elongate member 607 on the side near the penetrating device 615.

The elongated member further comprises an expandable member 611 that is adapted to expand after the elongated member has penetrated the stomach wall 12a and thus aids in the creation of a cavity or pocket adapted to maintain the volume filler device 610. Expandable member 611 may comprise an inflatable circular balloon provided circumferentially around the distal end portion of flexible elongate member 607.

The steps of the method when invagining the volume filling device will now be described in detail. After the instrument 600 has been inserted into the stomach 12, the stomach penetration device 615 is placed in contact with the wall of the stomach 12, see FIG. lOle. The stomach penetration device or the cutter 615 is then placed to form the hole 12b in the wall of the stomach, where after at least the expandable member 611 is put through the hole 12b in the stomach wall. The special support device 609 is brought into this state of maintenance where it is radially extended to form an essentially circular stirrup surface to the stomach wall 12, see Figure 10Olf. In this way, the insertion of the stomach penetration device 615 and the expandable member 611 through the hole 12 in the stomach wall is limited with the position shown in Figure 10Olf.

Expandable member 611 then expands. In the case the expandable member comprises a balloon or the like, the air or other fluid is injected therein.

The portion of the elongate member 607 comprising the expandable member 611 is then retracted in the proximal direction, as indicated by the arrow in Figure 10lg, thereby removing the stomach wall 612 in a basket or concave shape as the structure formed by the special support device 609.

A device of sutures or staples 608 are provided, additionally, as a device connected to the elongated member 607 or as a separate instrument. The suture or staple member comprises an end of sutures or staples 613 that is adapted to close the cavity or pouch by means of sutures or staples from stomach to stomach 14.

In a further step, illustrated in Figure 10, an inflatable stretching device 10 is placed in its deflated state in the concave shape as a structure. The stretching device 10 is then inflated to its inflated or expanded state, see Figure 10Oli. This inflation of the stretching device 10 can be carried out by injecting a fluid or a gel into the deflated stretching device. This can also be done by injecting a material that is allowed to cure, thereby creating a solid device 10. In this way, the stretching device 10 shown in Figures 101? and lOli can illustrate a balloon-like device that is subsequently filled with the fluid or gel or alternatively a material that is simply injected into the concave shape as the structure formed by the wall of the stomach 12.

The fluid that is used to fill the stretching device 10 could be any fluid suitable for filling the stretching device 10, such as a saline solution. In another embodiment, when this fluid is a fluid that is adapted to be transformed into the solid state, the fluid could be the fluid polyurethane.

In order to minimize or completely eliminate the effusion, the fluid is isotonic, that is, it has the same osmolarity as fluids of the human body. Another way to prevent diffusion is to provide a fluid that comprises large molecules, such as iodine molecules.

Stitches or stomach-to-stomach staples 14 are preferably provided with attachment portions that show a structure, such as a network-like structure, adapted to be in contact with the stomach wall 12 to promote human tissue growth to ensure the long-term placement of the stretching device attached to the stomach wall.

Thus, the inflatable stretching device 10 will be in its inflated or expanded state invaginated by a portion of the patient's stomach wall outside the stomach wall 12.

During one or more of the steps described above, the stomach can be inflated with the gas, preferably by means of the gastroscopic instrument.

The stretching device 10 described in the foregoing with reference to Figures 101a-101i has been described as an inflatable stretching device. It will be appreciated that it may also be an elastic stretch device with a spring allowance compression for insertion into a gastroscopic instrument and that it expands to an expanded state after leaving the instrument.

In one embodiment, the stretching device 10 comprises an inflatable stretching device 10 expandable to an expanded state. In this case, the inflatable stretching device 10 is provided with an inlet hole 18b for a fluid and is adapted to be connected to a gastroscopic instrument. This mode will now be described in detail with reference to Figures 102a-102d.

An inflatable stretching device in its unexpanded state is shown in Figure 102a. It is essentially a deflated, balloon-like device 10 which has an inlet hole 18b. In this state, the inflatable stretching device 10 has a diameter of a few millimeters at most, allowing it to insert into the stomach through the patient's esophagus by means of a gastroscope, the instrument 600 resembling a tube, or through laparoscopic trocar in a method laparoscopic abdominal using a tube as the instrument 600 depicted in Figure 102b. The instrument comprises an outer tubular part 600a and an internal tubular part 600b that can be displaced longitudinally relative to the outer tubular part. The internal tubular piece is provided with a cutter in the form of a cutting edge 615 to the distal end thereof. This cutting edge can be used to cut a hole in the wall of the stomach, as will be explained in detail in the following.

When the instrument reaches a wall of the stomach, inside and outside thereof, see Figure 102c, the internal tubular piece is presented from its position in the outer tubular piece and in contact with the stomach wall 12a. The cutting edge 615 of the internal tubular piece then cuts a hole in the wall of the stomach so as to allow the subsequent insertion of the volume filling device 10 into and through this orifice, see Figure 102d. In order to push the stretching device through the hole, a piston 602 can be provided in the instrument. In this way, the instrument further comprises a piston 602 adapted to push a deflated stretching device 10 from a position on the internal tubular part, this position shown in Figure 102b, to a position outside the part internal tubular, this is shown in Figure 102d.

In order to protect the deflated stretching device 10 from the cutting edge 615 of the inner tubular piece, an additional protective tubular piece (not shown) can be provided around the stretching device.

Figure 102a-102d shows an instrument for use in a method of engaging a stretching device 10 to the stomach wall 12 of a patient. The instrument is adapted to be inserted through a narrow shaped objective tube, such as a gastroscope, used in an intraluminal procedure, or laparoscopic trocar used in a laparoscopic procedure. The instrument comprises an elongated member 650 which is adapted to be flexible by means of a construction comprising a ring of multiple shaped members, however it is also possible to mention lengthened member 650 is adapted to be flexible by means of elongated member 650 which is made of a flexible or adjustable material. The elongated member 650 is inserted into the body and placed in proximity to the stomach wall 12 of the patient, exterior or interior thereof. The elongate member 650 has a special support device 651 adapted to maintain the stomach by means of mechanical grip members or vacuum. The special support device 651 comprises some first 652 sets and a second 653 sets, which allows the special holding device 651 to be operable relative to the elongated member 650 and thus place the part of the holding device 651 comprising the mechanical grip members or vacuum elements in contact with the stomach wall 12 of the patient. Figure 102b shows the special support device 651 when placed in contact with the stomach wall 12 of the human patient, after which the special possession member 651 connects with the stomach wall 12, to maintain the stomach wall 12. Figure 102c shows the instrument when the step of advancing a push bar 654 of the elongated member 650 is carried out. The push bar 654 pushes the wall of the stomach 12 to form a cavity or sachet thereof. Figure 102d shows the instrument 90 ° converted in relation to figures 102a-102c. This view shows the special holding members 651a, b operably linked to two sides of the elongate member 650 and being in contact with the wall of the stomach 12, keeping the stomach wall 12 as the push bar 654 pushes to form a cavity or sachet. When the push bar 654 has pushed the wall of the stomach 12 into a desired position the special maintenance devices 651a, b moves towards the push bar 654 and thus the cavity or sachet is closed.

After the cavity or sachet has formed it has to be sealed. Figure 103f shows the progress of suturing or staple device 655 of elongate member 650. A device of sutures or staples 655 is provided relative to the wall of the stomach after which a device of sutures or staples is provided. suture or stapling of the wall of the stomach 12, creating a suture or stitches seal from stomach to stomach 14. The instrument moves along the wall of the patient's stomach 12 and thus a cavity or sachet is created and sealed using the instrument, as shown in figure 103g and 103h. When a cavity or the sachet or the desired size has been formed and sealed- a inserting member 656 is advanced from the elongate member 650. The inserting member 656 is adapted to insert a stretching device 10 which is inflatable, as shown in FIG. describe earlier in this application. After the inserting member 656 has been placed in the cavity or sachet the stretching device 10 is inserted through the inserting member 656 and into the cavity or sachet by means of a pressurized fluid or gas, or a progressing member. Mechanical pushing the inflatable stretching device 10 into the cavity or sachet. The insertion member then inflates the inflatable stretching device with a fluid or gas and seals the final section of the sachet using the stomach to hold sutures or staples 14. The described embodiment explains the process of inserting an inflatable stretching device, however it is equally possible that the stretching device 10 is expandable by means of the stretching device 10 which is made of a material elastic.

Figures 104a-104f show an instrument for use in a method of engaging a stretching device 10 to the stomach wall 12 of a patient. The instrument is adapted to be inserted through a narrow shaped objective tube, such as a gastroscope, used in an intraluminal procedure, or laparoscopic trocar used in a laparoscopic procedure. The instrument comprises an elongate member 660 which is adapted to be flexible by means of a construction comprising a ring of multiple shaped members, however it is equally possible that said elongate member 660 is adapted to be flexible by means of the elongated member 660 is made of a flexible or adjustable material. The elongate member 660 is inserted into the body and placed in proximity to the stomach wall 12 of the patient, exterior or interior thereof. The elongated member 660 has multiple special holding devices 661 adapted to maintain the stomach by means of mechanical or vacuum grip members. The devices of special maintenance 661 are immobilized in a position adjacent the elongated member 660 by means of a locking ring 662. Special maintenance devices are made of a flexible material to expand in a chimney-like device when the sealing ring is removed 662 The special holding device in its expandable funnel-shaped state is shown in Fig. 104b. Figure 104b further shows the special support device 661 when placed in contact with the stomach wall 12 of the human patient, after which the special possession member 661 connects with the stomach wall 12, to maintain the stomach wall 12. Figure 104c shows the instrument when the step of advancing a push rod 664 of the elongated member 660 is carried out. The push rod 664 pushes the wall of the stomach 12 to form a cavity or sachet thereof. When the push rod 664 has pushed the stomach wall 12 to a desired position the special maintenance devices 661 advance the push bar 664 and consequently close the cavity or sachet.

After the cavity or sachet has formed it has to be sealed. Figure 104d shows the progress of suturing or staple device 665 of elongated member 660. A suture or staple device 665 is provided.

HE. place in relation to the wall of the stomach 12 after a device of sutures or staples 665 is provided they begin with suturing or stapling of the stomach wall 12, creating a seal of sutures or staples from stomach to stomach 14. Thereafter a member that inserts 666 is advanced from the elongated member 660 and the special maintenance devices 661 are retracted. The inserting member 666 is adapted to insert a stretching device 10 that is inflatable, as described earlier in this application. After the inserting member 666 has been placed in the cavity or sachet the stretching device 10 is inserted through the inserting member 666 and into the cavity or pocket by means of a pressurized fluid or gas, or a progressing member. Mechanical pushing the inflatable stretching device 10 into the cavity or sachet. The insertion member 656 then inflates the inflatable stretching device with fluid og "s and seals of the final section of the sachet using the stomach to hold sutures or staples 14. The described mode explains the process of inserting an inflatable stretch device 10, however it is equally possible that the stretching device 10 is expandable by means of the stretching device 10 which is made of an elastic material.Figure 40 shows the stretching device 10 the stretching device 10.

Stretch 10 is invaginated. in the wall of the stomach 12, in a cavity or sachet sealed with sutures or staples from stomach to stomach 14.

Figure 105a shows an instrument used in a method of engaging the stretching device according to any of the application modalities to the stomach wall 12. The instrument comprises an elongate member 670 that is adapted to be flexible by means of a construction comprising a ring of multiple shaped members, however it is equally possible that said elongate member 670 is adapted to be flexible by means of the elongate member 670 is made of a flexible or adjustable material. The elongate member 670 is inserted into the body and placed in proximity to the stomach wall 12 of the patient, from the interior thereof. A stomach penetrating member 672 is positioned at the distal end of elongate member 670, retractably attached to a tubular protective piece 673 adapted to protect tissue from the body of the sharp penetrating member 672 or cutter 672 after the cutting operation is performed. It has taken place.

Figure 105b shows the instrument comprising the elongated member 670 after the cutting operation has been carried out and the stomach penetration member or the cutter 672 has been retracted in the piece protective tubing 673. A guidewire 671 is pushed through the elongate member 670, through the hole made in the stomach wall 12 and through the abdomen and placed inside the patient's skin, which is penetrated from the outside to allow guide wire 671 out of the abdomen. The guide wire 671 can then be used to guide a conduit 18 or a cable attached to the stretching device 10 which is placed in the stomach from the inside thereof. The stretching device 10 with the conduit 18 or electric cable which is a stretching device 10 according to any of the modalities of this application. The direction of the conduit 180 or electric cable allows the connection of the conduit 18 or electric cable to a control unit 42 placed subcutaneously in the patient from the exterior of the abdomen.

Figure 106 shows a flow chart describing the steps necessary in an intraluminal method of inserting an apparatus for stretching a portion of the stomach wall, the method comprising the steps of inserting an instrument into the patient's esophagus 203, stage a, inserting an apparatus into the stomach of the patient through the esophagus 203 using the instrument, step 2a, placing the contact of 10 in the apparatus with the wall of the stomach 12, step 3a, fixing the apparatus to the wall of the stomach 12 such that the device can stretch a part of the wall of the stomach 12. The method described could further comprise the step of non-invasively regulating the device after the placement of an appliance has been completed.

Figure 107 shows a flow chart describing the steps necessary in an abdominal method of inserting an apparatus for stretching a portion of the stomach wall, the method comprising the steps of cutting a hole in the abdominal wall of the patient, stage Ib, dissecting an area around the stomach, stage 2b, placing the apparatus in contact with the stomach, stage 3b and fixing direct or indirect through invagination of the stomach wall the apparatus to the stomach wall such that the apparatus can stretch a portion of the stomach wall, step 4b. The described method could further comprise the steps of closing the hole in the abdomen using sutures or staples 14 and non-invasively regulating the device after the placement of the apparatus has been completed.

Figure 108 shows an embodiment of an apparatus according to the invention. Figure 108 shows the segments of a movement restriction device to be assembled prior to implantation in a patient in need of treatment against a reflux disease. The segments of the movement restriction device include a central part 560 and four parts external 561a-561d. The main part in general cylindrical is provided with an upper portion 560 'and is provided with four slots 562a-562d which are symmetrically distributed the end extends along the peripheral outside the main part. The outer portions 561a-561s are shown as being generally a part of the sphere having an inner and outer surface and each part is provided with a protruding flange 563a-563d extending along the inner surface. The tabs 563a-563d equal the slots 562a-562d as in the embodiment shown, but can be configured with free adjustments between tabs and slots as the assembled motion restriction device is sufficiently assembled to its position with implanted target specificity greater than the cardia. If the movement restriction device is accidentally moved from this position to the cavity of the stomach, a free-adjusting arrangement contributes to a faster disassembly of its segments. The main part is connected to a guide wire 564 which extends through the first channel 565 in the main part through a corresponding channel 565a between two surrounding holes in the protrusion 563a in the first external portion 561a. By acting on the guide wire 564 by moving it away from the upper surface of main part 560 'the first part 561a external will be displaced towards the main part and the flange 563a fulfills the slot 562a then the first external part is assembled to the main part 560. As shown in Figure 109, this performance is repeated with the second external part, now by the guide wire 564 through the second channel 566 connected with a corresponding channel in the tab 563b of the second external part 561b. Figure 110 shows this performance again for assembling the third part 561c external and third channel 567 joining the guide wire 564 to flange 563c. Figure 111 shows the fourth and last external part 561d assembled through the tab 563d and channel 568. Figure 112 shows the motion-restricted device finally assembled. Figure 113a is a more detailed view of the main part showing the channel system for the guide wire. Figure 113b through 113d are cross-sectional views of the planes I-I, II-II, III-III and IV-IV, respectively each at the level for four channels.

The guidewire is made of a biodegradable material that is degraded so that the segments are easily disassembled if the movement restriction device accidentally moves from its implanted position. The segments depicted are made of a solid biocompatible material and are each of the size and shape so that they easily pass through the gastrointestinal system if the restriction device of the movement is disassembled. By implanting the motion restriction device in this assembled manner, any of the methods previously described will be adequate.

Figure 114 shows an embodiment of the movement restriction device to be assembled. The outline of the main part and the segments is identical as shown in Figure 108, but the tabs of the segments 563a-d are provided with cavities 563 'ad that the mating protuberances 562' ad of the slots 562a- d of the main part so the assembled movement device becomes immobilized along two different planes. In this mode, these planes are perpendicularly configured. Figure 115 shows another embodiment of the motion restriction device according to Figure 114 without any guide wire and without any feature of the guide wire in the segments. This embodiment requires that the matching element fastening elements be adapted to assist with disassembly if the movement restriction device is accidentally displaced from its implanted position.

A method of injecting or inserting a plurality of segments of the movement restriction device into a sachet formed by a part of a stomach wall will now be described with reference to Figures 116a-116d. In this example, a motion restriction device as described above will be used with reference to Figures 50. A tube-like instrument, generally designated 600, as also shown in Figure 4b, comprises a tubular piece 600a having a diameter and transverse shape to allow passage of the main part 560 and the four external parts 561a-561d. A piston 602 is provided to move the segments of the movement restriction device through the tubular part 600a and into a space, wherein the segments of the movement restriction device must be assembled into or create a movement restriction device. As shown in Figure 116a, in this example the instrument 600 is used to insert or inject the segments of the movement restriction device through a hole 12a in a portion of the stomach wall 12 of a patient.

As shown in Figure 116b, the guidewire 564 forces the outer portions 561a-d ingest a respective position as petals to allow the main portion 560 to adopt an attitude allowing the outer portions 561a-d and the main portion 560 to meet in an essentially spherical movement restriction device 10. When removing guide wire 564, see Figure 116c ,. the external parts 561a-d move in the coupling with the main part 560, which is held in place by the interlaced tabs 563a-d.

Being completely assembled, see the Figure 116d, the essentially spherical motion restricting device 10 is invaginated in the part of the wall of the stomach 12 by means of sutures or staples 14. The limited space of the sachet formed by the stomach wall prevents the movement restriction device 10 collapses, even after the biodegradable guide wire 564 has been degraded. However, in case the movement restricting device 10 is released, such as by breaking the sutures or staples 14, the movement restricting device 10 is separated so that the different segments, each being smaller than the assembled movement restriction device 10, _ can pass through the gastrointestinal system. evident from the general description and appended claims that many other modes of designing the motion restriction device are possible without departing from the inventive concept. One such way is to leave a plurality of relatively small segments of the movement restriction device to form a motion restriction device, which will be described now with reference to Figures 117a-117c.

This method of injecting or inserting the segments of the movement restriction device into a sachet is similar to that described above with reference to Figures 47a-47d, after a sachet has been formed in the stomach wall. In this manner, Figure 117a illustrates a portion of the stomach wall 12a after sutures or the staples 14 have been applied to form a sachet in the stomach wall. The sachet can be provided using the method described above with reference to Figures 48a-48i.

The segments of the movement restriction device 10 are inserted or injected into the sachet by means of a gastroscopic or laparoscopic instrument 600, similar to a tube, as also shown in Figure 47b. The instrument comprises an external tubular piece and an internal tubular piece, see Figure 47b, which can be displaced longitudinally relative to the outer tubular piece. The internal tubular piece is provided with a cutter in the form of a cutting edge 615 to the distal end thereof. This cutting edge can be used to cut a hole in the wall of the stomach, as will be explained in detail in the following.

When the instrument reaches a wall of the stomach, the internal tubular piece is brought into position in the outer tubular piece and in contact with the. stomach wall 12a. The cutting edge 615 of the internal tubular piece then cuts a hole in the wall of the stomach so as to allow the subsequent insertion of the movement restricting devices 10 into and through this hole, see Figure 117b. In order to push the movement restriction device through the hole, a piston 602 can be provided in the instrument. In this way, the instrument further comprises a piston 602 adapted to push a plurality of movement restricting devices 10 from a position on the internal tubular part, this position shown in Figure 117a, to a position outside the tubular part. internal, this is shown in Figure 117b.

In order to protect the deflated motion restricting device 10 from the cutting edge 615 of the inner tubular piece, an additional protective tubular piece (not shown) can be provided around the movement restriction device.

The instrument 600 is similar to a tube in the shown embodiment provided with a cup-shaped expansion that holds the sachet in place during the insertion of the segments of the movement restriction device 10 into the sachet. By gradually removing the instrument similar to tube 600 during this process, see the Figure 117b, the sachet can be filled with segments of the movement restriction device 10 in a controlled mode.

After the sachet has been filled with segments of the movement restriction device to a desired degree, see Figure 117c, the hole 12b fraction in the stomach wall 12a by means of the instrument 600 is permanently closed by means of sutures or stapling , for example.

In the embodiment shown in Figures 117a-117c, the instrument 600 comprises a tube a piston 602 adapted to push or move the segments of the movement restriction device 10 along the tubular part 600b. Alternatively, as shown in Figure 118, the pressure exerted by the fluid can be used to push or move the segments of the motion restriction device 10.

The segments of the movement restriction device 10 can incorporate many different forms. In the embodiments shown in Figures 117a-117c and 118, these are essentially spherical. However, in alternative embodiments, they show one or a plurality of essentially planar or flat surfaces. Preferably, these are then incorporated in the form of polyhedra, such as tetrahedra, hexahedra, octahedra, dodecahedrons or icosahedron, that is, regular polyhedra with four, six, eight, twelve, and twenty flat surfaces, respectively. These examples of segments of the motion restriction device are shown in Figures 119a-119e.

The movement restriction devices can also be maintained in their mutual relationship by means of additional measures. For example, the surfaces of the segments of the movement restriction device may be provided with friction enhancing agent or material to minimize slippage of the segments of the movement restriction device. The friction enhancing agent may be a kind of glue or the like. Alternatively or in addition, the surface or the surfaces of the segments of the movement restriction device can be administered a rough texture that increase friction between segments of the adjacent movement restriction device.

As mentioned above, the movement restriction device 10 can be inflated with a gel or fluid supplied in a chamber defined by the movement restriction device 10, see Figure 120.

The insertion or injection of a plurality of segments of the movement restriction device 10 into Natural sachet provided by a portion of the stomach wall 12 has been described above with reference to Figures 117a-117d. However, in an alternative embodiment of an apparatus for treating obesity shown in Figure 121, the segments of the movement restriction device may also comprise a segment of motion restriction device to collect two or more other segments of the restriction device. of movement, which are of a different kind. In this way, the apparatus comprises a second segment of expander movement restriction device 10 'to collect two or more first segments of the movement restriction device 10 different from the second segment of motion restriction device, wherein the second segment of motion restriction device and the first segments of the movement restriction device together create the motion restriction device. It is preferred that the second segment of the movement restriction device is flexible or stretchable.

In an alternative embodiment, to permit reformation of the movement restriction device, there may be a friction reducing fluid to reduce friction between segments of the adjacent movement restriction device. In Figure 122, this is shown as a plurality of segments of the device, movement restriction 10 are provided in a sachet formed by the part of a stomach wall 12 and a fluid has been injected into this sachet, which allows mutual movement between the first segments of the device. adjacent movement restriction so that the shape of the movement restriction device adapts to the movements of the stomach wall, when the movement restriction device invaginates into a wall of the stomach.

The embodiments of Figure 121 and Figure 122 can be combined, so that a segment of external movement restricting device 10 'encloses both a plurality of the different, in this case spherical, segments of the movement restriction device 10 as well as a fluid. , which reduces friction between the different segments of the movement restriction device.

The fluid described above can, instead of reducing the friction between segments of the adjacent movement restriction device, enhance the friction between segments of the adjacent movement restriction device, thus making the movement restriction device more stable. The friction enhancing material can also be a glue or an adhesive, i.e. a fluid that solidifies.

Segments of the motion restriction device adapted to be used in a plurality to form a motion restriction device have been described above with reference to Figures 116a-116c and 119a-119e. It will be appreciated that these segments of the motion restriction device can be administered the same properties as the motion restriction devices described earlier with reference to materials, properties etc.

It is evident from the general description and appended claims that many other ways of designing the motion restriction device are possible without departing from this concept.

It should be noted that all modalities or characteristics of a modality as well as any method or stage of a method could be combined in any way if such a combination is not clearly contradictory. Please also note that the description in general should be observed as describing both an apparatus and a device adapted to carry out a method as well as this method itself.

A method or part of the method that is used in any combination and when using any apparatus or part of the apparatus or any feature in any combination where the steps of the method are applicable. follow, - wherein the method may comprise one or more of the following operational steps of the method: introduce the instrument in the narrowing, pass through the esophagus, placing an anvil or unit for administration of fixator members in the esophagus between the cardia and the level of the diaphragm, to engage in the fixation of the esophagus to the stomach tissue, to pass through the esophagus and further additionally down into the stomach, fill the stomach with gas to expand the stomach, suck the stomach fluid, observe in guiding vision when the instrument comprising a camera, attach the instrument to the stomach, create and drain at least one sachet from the stomach wall, filling at least one sachet with a fluid and / or volume filling device or two or more volume filling devices, administering a plurality of volume filling devices in the sachet formed in the stomach tissue through a tubular member, make it through the wall of the stomach with the instrument, pass through the wall of the stomach with the instrument to place a volume filling device outside the stomach wall, pass through the stomach wall with the instrument to place a tube permission placement from a subcutaneous injection hole, place a subcutaneous injection hole, suture or staple the wall of the stomach from the inside of it to the esophagus, Suture or staple the wall of the stomach to the stomach wall from inside the stomach, couple the instrument with the esophagus, suturing or stapling a layer of stomach tissue to a layer of esophageal tissue, suturing or stapling two layers of stomach tissue to a layer of esophageal tissue, Suture or staple three layers of stomach tissue to a layer of esophageal tissue, suturing or stapling four layers of stomach tissue to a layer of esophageal tissue, suturing or stapling one or more layers of the stomach tissue to two or more positions in the esophageal tissue, the esophagus that has a central axis of the esophagus, the esophagus that additionally has an internal and external surface substantially cylindrical extending radially relative to the central axis of the esophagus and where the stomach tissue is fixed to the esophageal tissue both at a first point along a first longitudinal axis of the esophageal surface, substantially parallel to the central axis of the esophagus and to a second point along a second longitudinal axis of the esophageal surface, substantially parallel to the central axis of the esophagus, at a distance from the first longitudinal axis of the esophageal surface, radially relative to the central axis of the esophagus, supply fixation members by means of a unit placed on the instrument, penetrate at least one layer of stomach tissue and a layer of tissue of the esophagus with fixation members s, place the fixation members above the gastroesophageal junction to form a tunnel between the esophagus and stomach above the junction, place a part of the esophagus in the esophagus and a part of stomach in the stomach, placing a fixation member substantially between the stomach and part of the esophagus, insert the instrument into the main stomach cavity through the cardia and adapt it to direct the instrument in the cranial direction to reach a position of the unit above the union, allowing in the tunnel a substantially unrestricted contraction and release of the closing sphincter muscle of the cardia placed at the junction, when the tunnel has been formed.

A method or part of the method that is used in any combination and when using any apparatus or part of the apparatus or any feature in any combination where the steps of the method that follow are applicable, wherein the method one or more of the following steps of the method operational: cut the skin of a patient create a hole in the patient's abdominal wall introduce the instrument into the abdominal cavity opening through in the abdominal wall, coupling the instrument with the stomach, removing the stomach wall to form at least one pre-shaped sachet of the stomach wall, holding the stomach wall to form at least one pre-shaped sachet of the stomach wall, suturing or stapling at least one pouch in the wall of the stomach, fill at least one sachet with a fluid and / or volume filler device or two or more devices volume filling, administering a plurality of volume filling devices in the sachet formed in the stomach tissue through a tubular member, pass through the stomach wall in the stomach with instrument, pass through the wall of the stomach with the instrument to place a volume filling device inside the stomach wall, pass through the wall of the stomach with the instrument to suture the wall of the stomach to the wall of the esophagus, place the volume filler device outside the stomach wall, invaginate the volume filler device in the wall of the stomach place a subcutaneous injection hole, suture or staple the wall of the stomach to the stomach wall from the outside of the stomach, suturing or stapling the wall of the stomach to the stomach wall from the outside of the stomach without penetrating the mucosa, Suture or staple two layers of stomach wall to one or two layers of stomach wall, couple the instrument with the esophagus, hold both sides of the esophagus to attach an esophageal wall layer to the stomach tissue, hold both sides of the esophagus and the fundus wall of the stomach to attach an esophageal wall layer to one or two layers of stomach tissue, introducing a tube or a gastroscopic instrument into the esophagus comprising an anvil member or a fixation delivery member that involves in the attachment of the esophagus to the stomach, coordinating the position of the anvil member or a fixation supply member within the esophagus to hold the instrument around the esophagus, suturing or stapling a layer of stomach tissue to a layer of esophageal tissue, suturing or stapling two layers of stomach tissue to a layer of esophageal tissue, Suture or staple three layers of stomach tissue to a layer of esophageal tissue, suturing or stapling four layers of stomach tissue to a layer of esophageal tissue, stapling using staples of different stapling depths in different positions in a row of staples, staple from stomach to esophagus with a first depth of staple and staple from stomach to stomach with a second smaller staple depth, stapling a pouch with sutures from stomach to stomach in a row of staples, which further comprises stapling the esophagus with staples of a greater depth included as a part of the staple row, suturing or stapling one or more layers of the stomach tissue to two or more positions in the esophageal tissue, the esophagus having a central axis of the esophagus, the esophagus having additionally an internal and external substantially cylindrical surface extending radially relative to the central axis of the esophagus and where the stomach tissue is fixed to the esophageal tissue both at a first point along a first longitudinal axis of the esophageal surface, substantially parallel to the central axis of the esophagus and to a second point along a second longitudinal axis of the surface of the esophagus, substantially parallel to the central axis of the esophagus, at a distance from the first longitudinal axis of the esophageal surface, radially relative to the central axis of the esophagus, supply fixation members by means of a unit placed on the instrument, penetrate at least one layer of stomach tissue and a layer of tissue of the esophagus with fixation members s, place the fixation members above the gastroesophageal junction to form a tunnel between the esophagus and stomach above the junction, allow in the tunnel a substantially unrestricted contraction and release of the closing sphincter muscle of the cardia placed at the junction, when the tunnel has been formed, place a part of the esophagus in the esophagus and a part of stomach in the stomach through an introduction into the stomach cavity, placing a fixation member substantially between the stomach and part of the esophagus, inserting the instrument into the main stomach cavity below the union and adapted to direct the instrument in the cranial direction to reach an assembly position above the joint, operating a joint comprised in the instrument, to allow the instrument to be inserted into the main stomach cavity by bending the joint in one direction to reach a position of the part of the unit in the esophagus above the joint.

A method or part of the method that is used in any combination and when using any apparatus or part of the apparatus or any feature in any combination where the steps of the method are applicable. follow, wherein the method comprises operational method steps one or more of the following steps of the laparoscopic operational method: cut the skin of a patient introduce a tube through the abdominal wall, fill with a fluid or gas the abdominal cavity, introduce two or more trocars in the abdominal cavity, introduce a camera in the abdominal cavity through one of the trocars, introduce the instrument into the abdominal cavity through a trocar, attach the instrument to the stomach, remove the stomach wall to form at least one pre-shaped sachet of the stomach wall, hold the stomach wall to form at least one pre-shaped sachet of the stomach wall, suture or staple at least one pouch on the wall of the stomach, filling at least one sachet with a fluid and / or a volume filling device or two or more volume filling devices, administering a plurality of volume filling devices in the sachet formed in the stomach tissue through a tubular member, pass through the stomach wall in the stomach with instrument, pass through the wall of the stomach with the instrument to place a volume filling device inside the stomach wall, pass through the wall of the stomach with the instrument to suture the wall of the stomach to the wall of the esophagus, place the volume filler device outside the stomach wall, invaginate the volume filler device in the wall of the stomach place a subcutaneous injection hole, suture or staple the wall of the stomach to the stomach wall from the outside of the stomach, Suture or staple two layers of stomach wall to one or two layers of stomach wall, suturing or stapling the wall of the stomach to the stomach wall from the outside of the stomach without penetrating the mucosa, couple the instrument with the esophagus, hold both sides of the esophagus to attach an esophageal wall layer to the stomach tissue, hold both sides of the esophagus and the fundus wall of the stomach to fix a layer of esophageal wall to one or two layers of stomach tissue, introducing a tube or a gastroscopic instrument into the esophagus comprising an anvil member or a fixation delivery member that involves in the attachment of the esophagus to the stomach, coordinating the position of the anvil member or a fixation supply member within the esophagus to hold the instrument around the esophagus, suturing or stapling a layer of stomach tissue to a layer of esophageal tissue, suturing or stapling two layers of stomach tissue to a layer of esophageal tissue, Suture or staple three layers of stomach tissue to a layer of esophageal tissue, suturing or stapling four layers of stomach tissue to a layer of esophageal tissue, stapling using staples of different stapling depths in different positions in a row of staples, staple from stomach to esophagus with a first depth of staple and staple from stomach to stomach with a second depth of staple smaller, stapling a pouch with sutures from stomach to stomach in a row of staples, which additionally comprises stapling the esophagus with staples of a greater depth included as a part of the staple row, suturing or stapling one or more layers of the stomach tissue to two or more positions in the esophageal tissue, the esophagus having a central axis of the esophagus, the esophagus having additionally an internal and external substantially cylindrical surface extending radially relative to the central axis of the esophagus and where the stomach tissue is fixed to the esophageal tissue both at a first point along a first longitudinal axis of the esophageal surface, substantially parallel to the central axis of the esophagus and to a second point along a second longitudinal axis of the surface of the esophagus, substantially parallel to the central axis of the esophagus, at a distance from the first longitudinal axis of the esophageal surface, radially relative to the central axis of the esophagus, supply fixation members by means of a unit placed on the instrument, penetrate at least one layer of stomach tissue and a layer of tissue of the esophagus with fixation members s, place the fixation members above the gastroesophageal junction to form a tunnel between the esophagus and stomach above the junction, allow a shrinkage in the tunnel substantially unrestricted and release of the closing sphincter muscle of the cardia placed at the junction, when the tunnel has been formed, place a part of the esophagus in the esophagus and a part of stomach in the stomach through an introduction into the stomach cavity, placing a fixation member substantially between the stomach and part of the esophagus, inserting the instrument into the main stomach cavity below the union and adapted to direct the instrument in the cranial direction to reach an assembly position above the joint, operating a joint comprised in the instrument, to allow the instrument to be inserted into the main stomach cavity by bending the joint in one direction to reach a position of the part of the unit in the esophagus above the joint.

It should be noted that any modality or part of. the mode as well as any method or part of the method or any apparatus or part of the apparatus or any characteristic or part of the feature or any system or part of the system could be combined in any applicable way. All the examples here should be observed as parts of the general description and therefore are possible to be combined in any way in terms general.

While the specific embodiments of the invention have been illustrated and described in this document, various other embodiments can be implemented and the various additional advantages, modifications and changes will readily occur to those skilled in the art without departing from the spirit. and the scope of the invention. Therefore, the invention in its broader aspects is not limited to the specific details, representative devices and illustrated examples shown and described herein. Accordingly, various modifications may be made without departing from the spirit or scope of the general inventive concept as defined by the appended claims and their equivalents. It is to be understood therefore that the appended claims are intended to cover all such modifications and changes as are included within a true spirit and scope of the invention. Various other modalities can be provided without departing from the spirit and scope of the invention.

Claims

1. An apparatus for treating reflux disease in a human or animal mammalian patient, the apparatus comprising two or more segments of the movement restraint device adapted to form an implantable movement restriction device having an external surface with an adapted elongated shape to be invaginated at least in part by a portion of the wall of a patient's stomach, the movement restriction device having, when implanted in a patient, a proximal part and a distant part; wherein the motion restricting device is adapted to be supported at least partially on the outer surface of its proximal part against the fundus wall of the patient's stomach, in a position between the diaphragm of the patient and the wall of the fundus, such that the movement of the cardiac notch of the patient's stomach towards the diaphragm of the patient is restricted, when the motion restriction device is implanted in the patient, to prevent the heart from slipping through the opening of the patient's diaphragm in the thorax of the patient, to maintain support pressure against the cardiac sphincter muscle exerted from the patient's abdomen; and wherein the distant part of the motion restriction device stabilizes and maintains the proximal part, the part distant that adapts to be substantially invaginated in the wall of the stomach.

2. The apparatus according to claim 1, wherein the invaginated part distant from the elongated motion restriction device is of sufficient length to stabilize the proximal portion of the elongated motion restriction device to prevent the heart from slipping through the aperture of the diaphragm. of the patient in the patient's chest.

3. The apparatus according to claim 1, wherein the circumference of the invaginated part remote from the elongated motion restriction device is sufficient to stabilize the proximal portion of the elongated motion restricting device to prevent the heart from slipping through the opening of the diaphragm of the patient in the patient's chest.

4. The apparatus according to claim 1, wherein the proximal part of the movement restriction device has a size of at least 125 mm3 and a circumference of at least 15 mm.

5. The apparatus according to claim 1, comprising a fastening device adapted to secure the proximal portion of the movement restriction device in its position, when the motion restriction device is implanted.

6. . The apparatus in accordance with the claim 5, wherein the fixation device comprises a first implantable fixation device which, when implanted in the patient, attaches the proximal part of the movement restriction device to the wall of the fundus to maintain the movement restriction device in its place. position.

7. The apparatus according to claim 1, wherein the proximal portion of the movement restriction device is non-adjustable from outside the body of a patient when implanted in the patient.

8. The apparatus in accordance with the claim 6, wherein the first fixation device comprises a tissue growth promoting structure for the long-term attachment of the proximal portion of the movement restriction device to the stomach wall without intussusception.

9. The apparatus according to claim 8, wherein the tissue growth promoting structure comprises a network-like structure.

10. The apparatus according to claim 9, wherein the tissue growth promoting structure further comprises sutures or staples which, when implanted in the patient, attach the network-like structure to the wall of the fundus of the stomach.

11. The apparatus according to claim 5, wherein the fixation device comprises sutures or staples which, when implanted in the patient, join together portions of the fundus wall of the stomach that enclose the motion restriction device to secure the device of restriction of movement in its position.

12. The apparatus according to claim 11, wherein the sutures or staples, when implanted in the patient to join together portions of the fundus wall of the stomach, invaginate the motion restriction device in the fundus wall of the stomach to maintain so the motion restriction device in place.

13. The apparatus according to claim 11, wherein the sutures or staples, when implanted in a patient with the movement restriction device, jointly portions of the fundus wall of the stomach so as to invaginate the restriction device of the stomach. movement from inside the patient's stomach wall.

14. The apparatus according to claim 11, wherein the sutures or staples, when implanted in a patient with the proximal part of the movement restriction device, join together portions of the fundus wall of the stomach tan a to invaginate the restriction device of classification movement from outside the patient's stomach wall.

15. The apparatus according to claim 6, wherein the fixation device comprises a second fixation device that, when implanted in the patient with the proximal part of the movement restriction device, secures, indirectly or directly, the restriction device. of movement to the esophagus near the angle of the patient's His.

16. The apparatus according to claim 15, wherein the second fixation device comprises a plurality of sutures or staples that, when implanted in the patient with the motion restriction device, join the wall of the fundus and a wall of the esophagus of the patient to keep the movement restriction device in its position.

17. The apparatus according to claim 15, wherein the fixation device comprises a third fixation device which, when implanted in the patient with the proximal part of the movement restriction device, secures, indirectly or directly, the restriction device. of movement to the patient's diaphragm muscle or other muscle tissue.

18. The apparatus according to claim 17, wherein the third fixation device comprises a plurality of sutures or staples which, when implanted in the patient with the motion restriction device, join the wall of the fundus and the diaphragm muscle or Another muscle tissue to keep the movement restriction device in its position.

19. The apparatus according to claim 1, wherein the proximal portion of the movement restriction device comprises a body adapted to be at least partially invaginated by the fundus wall of the patient's stomach and having an outer surface that includes a biocompatible material, a considerable part of the external surface of the body that is adapted to lean against the wall of the stomach in its position between the diaphragm of the patient and the portion of the lower part of the wall of the fundus of the invaginated stomach.

20. The apparatus according to claim 19, wherein the body is substantially the shaped egg.

21. The apparatus according to claim 19, wherein the body is substantially shaped as an egg with a toothed intermediate section.

22. The apparatus in accordance with vindication 19, wherein the body is substantially shaped as a folded egg.

23. The apparatus according to claim 19, wherein the body has rounded contours without too sharp edges that would be detrimental to the patient's stomach wall.

24. The apparatus according to claim 19, further comprising means adapted to regulate the size of the body being implanted in the patient.

25. The apparatus according to claim 19, wherein the body forms a chamber containing the fluid, the amount of which is controllable to adjust the size of the body, when the body is implanted in the patient.

26. The apparatus according to claim 19, wherein the size of the body is non-invasively adjustable by being implanted in the patient.

27. The apparatus according to claim 19, wherein the body is adapted to be placed within the wall of the patient's stomach by means of a gastroscope or intraluminal instrument.

28. The apparatus according to claim 19, wherein the implantable body has a generally smooth external surface to be supported against the wall of the fundus.

29. The apparatus according to claim 19, wherein the body is implantable within the patient's stomach.

30. The apparatus according to claim 19, wherein the body is adapted to be fixed to the patient's stomach wall by surgery.

31. The apparatus according to claim 19, wherein the body is adapted to be placed outside the patient's stomach.

32. The apparatus according to claim 19, wherein the body is changeable to assume a thin shape having a smaller diameter than that of a trocar for laparoscopic use, whereby the body when changed to the thin form can be pushed or removed through the trocar.

33. The apparatus according to claim 19, wherein the body comprises a flexible outer wall defining a fluid filled chamber, allowing the body to pass through a trocar for laparoscopic use.

3 . The apparatus according to claim 25, wherein the fluid comprises a gel.

35. The apparatus according to claim 19, wherein the body is hollow and comprises at least two separate product units adapted to be inserted into the hollow body, and further adapted to be assembled into a unitary piece within the body, thereby allowing the body to pass through a trocar for laparoscopic use.

36. The apparatus according to claim 19, wherein the body comprises an external wall and a hollow compressed internal part, to be filled with a fluid or gel after insertion into the body of a patient.

37. The apparatus according to claim 19, wherein the body comprises a chamber with an injection orifice, and the chamber of the body is filled with a fluid through the injection orifice.

38. The apparatus according to claim 19, wherein the body comprises an elastic compressible material, allowing the body to pass through a trocar for laparoscopic use.

39. The apparatus according to claim 19, wherein the body is made of a material softer than 25 Shore.

40. The apparatus according to claim 19, wherein the body is made of a material softer than 15 Shore.

41. The apparatus in accordance with Claim 19, wherein the body comprises an outer wall that substantially takes the form of a ball.

42. The apparatus according to claim 19, wherein the body comprises at least one support device adapted to be used to push or withdraw the body through a trocar for laparoscopic use.

43. The apparatus according to claim 42, wherein the support device is adapted to maintain an extension of the device that is adapted to be maintained by a surgical instrument.

44. The apparatus according to claim 42, wherein the holding device is adapted to maintain a thread or band inserted through the holding device.

45. The apparatus according to claim 42, wherein the body comprises an external wall and the support device is at least partly placed inside the external wall of the body.

46. The apparatus according to claim 19, wherein the body is dimensioned with a larger size than the intestinal outlet of the stomach.

47. The apparatus according to claim 19, wherein the body has the outer diameter smaller than 30 m or greater.

48. . The apparatus according to claim 19, wherein the body has the smallest outer diameter of 40 mm or greater.

49. The apparatus according to claim 19, wherein the body has the outer circumference smaller than 90 mm.

50. The apparatus according to claim 19, wherein the body has the outer circumference smaller than 70 mm.

51. The apparatus according to claim 19, wherein the body has the outer circumference smaller than 50 mm.

52. The apparatus according to claim 19, wherein the body has the outer circumference smaller than 30 mm.

53. The apparatus according to claim 19, wherein the body has the smallest outer circumference of 110 mm.

54. The apparatus according to claim 19, wherein the body has the smallest outer circumference of 130 mm.

55. The apparatus according to claim 19, wherein the body has the smallest outer circumference of 150 mm.

56. The apparatus in accordance with Claim 1, comprising. additionally an adjustment device for adjusting at least the proximal part of the movement restriction device.

57. The apparatus according to claim 56, wherein the size of the movement restriction device is hydraulically adjustable, and the adjustment device comprises a reservoir of hydraulic fluid which, when implanted in the patient, is connected to the restriction device of movement, and where the size of motion restriction devices is non-invasively regulated by the movement of the hydraulic fluid between the hydraulic fluid reservoir and the movement restriction device.

58. The apparatus according to claim 57 further comprising a hydraulic regulating device comprising at least one chamber which, when implanted in the patient, invaginates into the wall of the patient's stomach with the body and connected to the body, and wherein the amount of hydraulic fluid contained in the body is non-invasively regulated by distributing the fluid between the hydraulic reservoir and the at least one chamber.

59. The apparatus according to claim 58, wherein the at least one chamber is, when implanted in the patient, filled with the fluid Hydraulic using a pump in the reservoir to stretch the fundus wall to create satiety in the patient.

60. The apparatus according to claim 56, comprising three reservoirs adjustable with the hydraulic fluid, wherein a small volume of fluid in a first reservoir placed subcutaneously, being the part of a first closed system including a second reservoir, is compressed with a high power per unit area to move a small volume of hydraulic fluid, and where the second tank affects a larger volume of hydraulic fluid in a third tank, the third tank which is the part of a second closed system that has the largest volume that the first deposit, consequently creating a movement of a larger total volume of the hydraulic fluid with less force per unit area.

61. The apparatus according to claim 19, wherein the body forms a first chamber, further comprising at least one additional body forming a second chamber smaller than the first chamber, the first and second chambers being in contact with each other. .

62. The apparatus according to claim 61, wherein the first and second chambers are in fluid communication with each other.

63. The apparatus in accordance with claim 57, wherein the hydraulic reservoir is adapted to be placed subcutaneously in the patient.

64. The apparatus according to claim 57, wherein the hydraulic reservoir is adapted to be placed on the patient's abdomen.

65. The apparatus according to claim 57, wherein the hydraulic reservoir has a wall defining the volume thereof, and the volume of the hydraulic reservoir is regulated by the movement of a portion of the wall of the wall of the hydraulic reservoir.

66. The apparatus according to claim 65, further comprising a motor for moving the portion of the wall.

67. The apparatus according to claim 58, wherein the hydraulic regulating device comprises a pump, and the hydraulic reservoir is regulated by the pump pumping fluid between the hydraulic reservoir and at least one chamber.

68. The apparatus according to claim 58, further comprising a mechanical device operatively connected to the hydraulic regulating device to move as the hydraulic regulating device is operated.

69. The apparatus according to claim 1, wherein at least the next part of the device. Movement restriction is regulated mechanically.

70. The apparatus according to claim 69, further comprising a motor for mechanically regulating the motion restriction device.

71. The apparatus according to claim 19, further comprising a second body that, when implanted in the patient with the body, fills two volumes, respectively, to two different parts of the patient's stomach, thereby affecting the reflux of the patient. .

72. The apparatus according to claim 71, wherein the reflux disease treatment device is adapted to be post-functionally and non-invasively regulated, and adapted to be regulated from time to time such that a first time one of the bodies of filling fills the volume to one part of the stomach and to a second time that the others of the filling bodies fill the volume to the other part of the stomach.

73. The apparatus according to claim 1, further comprising at least one adjustable stretching device that, when implanted in the patient, stretches a part of the patient's stomach wall, to treat accordingly the obesity affecting the patient's appetite.

74. The apparatus according to claim 1, wherein at least the proximal part of the movement restriction device comprises a stretching device which, when implanted in the patient, stretches a part of the patient's stomach wall, to treat consequently obesity affecting the patient's appetite.

75. The apparatus according to claim 74, wherein the motion restricting device comprises a body having a chamber, and further comprising a second chamber in fluid contact with the body chamber.

76. The apparatus according to claim 75, wherein the second chamber is smaller than the body.

77. The apparatus according to claim 75, wherein the body and the second chamber are, when implanted in the patient, in communication with each other, whereby the fluid or air moves between the body and the second chamber.

78. The apparatus according to claim 75, wherein the body chamber is a main chamber, and the second chamber, when implanted in the patient, functions as a stretching device to treat obesity, the main chamber and the second chamber, when implanted in the patient, who is in communication with each other, whereby fluid or air move between the main chamber and the second chamber, causing consequently a stretching effect on the fundus wall of the patient's stomach to treat obesity accordingly.

79. The apparatus according to claim 74, wherein the proximal portion of the motion restriction device comprises a body that, when implanted in the patient, is adjustable in size and invaginated in the fundus wall of the patient's stomach, by which the body stretches the fundus wall of the stomach of the patient when the size of the same is increased, creating in consequence the satiety in the patient.

80. The apparatus according to claim 1 further comprising at least two implantable adjustable stretching devices which, when implanted in the patient, stretch different parts of the stomach wall of the patient, to thereby treat obesity by affecting the patient's appetite. patient.

81. The apparatus according to claim 80, wherein the two stretching devices, when implanted in the patient, are regulated from outside the body of a patient, whereby a first of the stretching devices is regulated a first time to stretch a first part of the patient's stomach wall and a second of the stretching devices is adjusted a second time to stretch a second part of the patient's stomach wall .

82. The apparatus according to claim 74 or 80, wherein the stretching device is hydraulically regulated, further comprising a hydraulic reservoir connected to the regulated hydraulic stretch device, whereby the regulated hydraulic stretch of the device, when implanted in the patient is adapted to be non-invasively regulated using the hydraulic reservoir fluid.

83. The apparatus according to claim 82, wherein the hydraulic reservoir, when implanted in the patient, is implanted subcutaneously and non-invasively regulated by manually pressing the reservoir.

84. The apparatus according to claim 82, wherein the motion restricting device comprises an inflatable body, further comprising a pump and a chamber in fluid contact with the body, and wherein the pump, when implanted in the patient, regulates the hydraulic reservoir by pumping fluid or body air into the chamber.

85. The apparatus according to claim 74 or 80, further comprising a wireless remote control, wherein the stretching device, when implanted in the patient, is non-invasively regulated by the wireless remote control.

86. The apparatus according to claim 80, further comprising a source of energy that drives the adjustable stretching device, when implanted in the patient.

87. The apparatus according to claim 86, wherein the energy source comprises an internal energy source implantable in the patient.

88. The apparatus according to claim 86, wherein the energy source comprises an external energy source that transmits the wireless energy.

89. The apparatus according to claim 88, further comprising an internal energy source implantable in the patient ie when implanted in the patient, chargeable by the wireless energy transmitted by the external energy source.

90. The apparatus according to claim 1, further comprising a first implantable fixation device which, when implanted in the patient, secures the proximal portion of the device restriction of movement in its position with the external surface of the movement restriction device that substantially puts in contact with the fundus wall of the patient's stomach, a second implantable fixation device which, when implanted in the patient, secures the proximal of the direct or indirect movement restriction device to the esophagus, and a third implantable fixation device that, when implanted in the patient, secures the proximal portion of the movement restriction device to the diaphragm muscle of the patient or other muscle tissue.

91. The apparatus according to claim 90, wherein each of the fixation devices comprises a plurality of sutures or staples.

92. The apparatus according to claim 19, wherein the body has a maximum circumference as seen in. a plane perpendicular to an axis through the body, and when comparing two consecutive joined planes that circulate the axis, the circumference decreases or is constant since the planes are displaced along the axis, starting from the maximum circumference and moving in one or two directions away from the maximum circumference, as the planes are displaced along the axis.

93. The apparatus in accordance with claim 19, wherein the body circumference, wherein the body has a circumference as observed in a plane perpendicular to at least one axis through the body, and by comparing two such consecutive joined planes that circulate the axis, that the axis that has two endpoints, increases in circumference at least twice or decreases at least twice or that has a greater circumference than the endpoints compared to the smallest circumference between the endpoints, since planes are displaced along the axis.

94. The apparatus according to claim 1, wherein the proximal portion of the motion restricting device is adapted to be substantially invaginated by the fundus wall of the patient's stomach.

95. The apparatus according to claim 1, further comprising a fastening device adapted to attach the proximal portion of the motion restriction device to the wall of the fundus to maintain the motion restriction device in place, when the device is implanted. of restriction of movement.

96. The apparatus according to claim 1, wherein the proximal part of the device Motion restriction is inflatable and adapted to be inflated with a gel or fluid.

97. The apparatus according to claim 96, further comprising a fluid or gel receiving member for receiving the fluid to inflate the motion restriction device.

98. The apparatus according to claim 1, wherein the proximal part of the movement restriction device includes a homogeneous material.

99. The apparatus according to claim 98, wherein the proximal portion of the movement restriction device comprises at least a part of a solid body.

100. The apparatus according to claim 1, wherein the proximal portion of the movement restriction device comprises an enclosing wall defining a chamber.

101. The apparatus according to claim 1, wherein the proximal part of the movement restriction device has at least a part with a rigid external wall.

102. The apparatus according to any claim according to claim 1, wherein the proximal part of the movement restriction device has at least a part with a wall external elastic.

103. The apparatus according to any one of claim 1, wherein the proximal portion of the movement restriction device has at least one part with a flexible outer wall.

104. The apparatus according to claim 101, wherein the rigid outer wall is quite rigid where it remains non-deformed when subjected to forces formed by movements of the stomach.

105. The apparatus according to claim 1, wherein the motion restriction device is adapted to pass through a laparoscopic trocar or a gastroscopic trocar or instrument.

106. The apparatus according to claim 1, wherein the motion restriction device is capable of changing shape to be capable of passing laparoscopic trocar or a gastroscopic trocar or instrument.

107. The apparatus according to claim 1, wherein the motion restricting device has a rounded shape without too sharp edges such that the stomwall is not impaired by the movement restriction device when implanted.

108. The apparatus in accordance with Claim 1, wherein the volume of the motion restriction device is non-invasively adjustable.

109. The apparatus according to claim 1, wherein the motion restricting device is adapted to be completely invaginated by the fundus wall of the patient's stom

110. The apparatus according to claim 1 wherein the movement restriction device is adapted to be invaginated with the motion restriction device placed therein within the wall of the fundus of the stom

111. The apparatus according to claim 1, further comprising an injection orifice adapted to be connected to an inflatable chamber of the movement restriction device to adjust the volume of the inflatable chamber.

112. The apparatus according to claim 1, further comprising a holding device for maintaining the movement restriction device during the implant thereof.

113. The apparatus according to claim 1, wherein at least a portion of the movement restriction device is made of a material that is destructible by stomacid.

114. The apparatus in accordance with claim 1, wherein at least a portion of the movement restriction device is made of a material that is not destructible by stomacid.

115. The apparatus according to claim 19, wherein the body has a circumference as observed in a plane perpendicular to an axis through the body, and where the circumference constantly increases or remains constant as the axis of a first endpoint circulates from the axis to an intermediate point with a maximum, and the circumference constantly decreases or remains constant when in motion from the intermediate point to a second endpoint of the axis.

116. The apparatus according to claim 19, wherein the body has a circumference as observed in a plane perpendicular to an axis through the body, and where the circumference constantly increases or remains constant as the axis of a first endpoint circulates from the axis to a first intermediate point with a first maximum, the circumference constantly decreases or remains constant when in movement from the first intermediate point to a second intermediate point with the first minimum, the circumference constantly increases or remains constant as the axis of the second point moves intermediate of the axis to a third intermediate point with a second maximum, and the circumference constantly decreases or remains constant when in motion from the third intermediate point to a second endpoint of the axis.

117. The apparatus according to claim 1, wherein the distal portion of the elongated motion restriction device invaginates into the stomwall such that the volume of the alimentary cavity is reduced in size by a volume that substantially exceeds the volume of the distant part of the elongated movement restriction device.

118. The apparatus according to claim 117, further adapted to also threat obesity by reducing the volume of the food cavity by volume that substantially exceeds the volume of the elongated motion restriction device.

119. The apparatus according to claim 118, wherein the distal portion of the movement restriction device has a maximum circumference of at least 3 millimeters.

120. The apparatus according to claim 1, wherein the distal portion of the movement restriction device comprises an inflatable device expandable to an expanded state.

121. The apparatus according to claim 120, wherein the inflatable device has an inlet port for a fluid or a gel and is adapted to be connected to a gastroscopic or laparoscopic instrument.

122. The apparatus according to claim 121, wherein the inlet orifice comprises a fluid connection adapted to interconnect the inflatable device and the gastroscopic or laparoscopic instrument.

123. The apparatus according to claim 117, wherein the distal portion of the movement restriction device has a rounded shape.

124. The apparatus according to claim 117, wherein the distal portion of the movement restriction device has a curved ease or shape.

125. The apparatus according to claim 117, wherein at least a portion of the distal portion of the movement restriction device comprises an elastic material.

126. The apparatus according to claim 117, wherein at least a part of the remote part of the movement restriction device It includes silicone.

127. The apparatus according to claim 1, wherein at least one of the proximal portion and the distal portion of the movement restriction device is provided with at least one layer.

128. The apparatus according to claim 127, wherein the at least one layer comprises a Parylene layer.

129. The apparatus according to claim 127, wherein the at least one layer comprises a layer of polytetrafluoroethylene.

130. The apparatus according to claim 127, wherein the at least one layer comprises a layer of polyurethane.

131. The apparatus according to claim 117, wherein the distal portion of the motion restriction device comprises a fluid.

132. The apparatus according to claim 131, wherein the fluid is adapted to be transformed into a solid or fixed state.

133. The apparatus according to claim 131, wherein the fluid is the fluid polyurethane.

134. The apparatus in accordance with Claim 131, wherein the fluid is isotonic.

135. The apparatus according to claim 131, wherein the fluid comprises large molecules to prevent diffusion.

136. The apparatus according to claim 131, wherein the fluid comprises iodine molecules.

137. The apparatus according to claim 117, wherein at least a part of the distal portion of the movement restriction device a homogeneous material.

138. The apparatus according to claim 117, wherein at least a portion of the distal portion of the movement restriction device is a solid body.

139. The apparatus according to claim 117, wherein at least a portion of the distal portion of the movement restriction device comprises an enclosing wall defining a chamber.

140. The apparatus according to claim 117, wherein at least a portion of the distal portion of the movement restriction device comprises a rigid external surface.

141. The apparatus according to claim 117, wherein at least a part of the Distant part of the movement restriction device comprises an elastic outer surface.

142. The apparatus according to claim 117, wherein at least a portion of the distal portion of the movement restriction device comprises a flexible outer surface.

143. The apparatus according to claim 117, wherein the distal portion of the movement restriction device as a maximum circumference of at least 5 millimeters.

144. The apparatus according to claim 117, wherein the distal portion of the motion restriction device has a circumference of at least 8 millimeters.

145. The apparatus according to claim 117, wherein the remote part of the movement restriction device has a volume between 0.00001 and 0.001 m3.

146. The apparatus according to claim 145, wherein the remote part of the movement restriction device has a volume between 0.00001 and 0.0002 m3.

147. The apparatus according to claim 117, wherein the distal portion of the motion restriction device is deformable to a maximum diameter, to be inserted into a laparoscopic trocar.

148. The apparatus according to claim 117, wherein the distal portion of the movement restriction device is adapted to be held in place by sutures or staples from stomach to stomach to invaginate the device in the stomach wall.

149. The apparatus according to claim 148, wherein stomach-to-stomach sutures or clips are provided with fixation portions that show a structure adapted to be in contact with the stomach wall to promote human tissue growth to ensure placement of the distant part of the movement restriction device attached to the stomach wall.

150. The apparatus according to claim 149, wherein the structure comprises a network-like structure.

151. The apparatus according to claim 117, wherein the distal portion of the movement restriction device is adapted to be non-invasively post-functionally adjustable.

152. The apparatus according to claim 117, wherein the distal portion of the motion restriction device has a variant circumference to be better adapted to stay in place invaginated in the wall of the patient's stomach.

153. The apparatus according to claim 117, comprising a stretching device positioned outside the wall of the stomach and adapted to stretch a part of the stomach wall, thereby affecting the appetite of the patient, the apparatus further comprising fluid connection that interconnects the stretching device and the distant part of the movement restriction device.

154. The apparatus according to claim 117, wherein the distal portion of the movement restriction device is adapted to be placed within the stomach wall through a gastroscopic instrument.

155. The apparatus according to claim 117, wherein the distal portion of the movement restriction device comprises at least two interconnectable portions adapted to be placed within the stomach wall as separate portions.

156. The apparatus according to claim 117, wherein the distal portion of the motion restriction device comprises a layer of external surface of at least one of polyurethane, Teflon, or PTFE, Parylene, gold, silver, titanium or other metal.

157. The apparatus according to claim 117, wherein at least the distal portion of the movement restriction device is non-destructible by the acid, preferably hydrochloric acid.

158. The apparatus according to claim 117, wherein the distal portion of the motion restriction device comprises a gel.

159. The apparatus according to claim 158, wherein the gel has a Shore value less than 15.

160. The apparatus according to claim 117, wherein the. Distant part of the movement restriction device comprises a joining device adapted to cooperate with a grasping instrument.

161. The apparatus according to claim 117, wherein the distal portion of the motion restriction device is adapted to be completely invaginated by the wall of the patient's stomach.

162. The apparatus according to claim 161 comprising a fixing device adapted to the distal portion to fix the movement restriction device to the stomach wall to maintain the distal portion of the movement restriction device, when the proximal portion of the movement restriction device is implanted.

163. The apparatus according to claim 117, wherein the remote part · of the movement restriction device has a volume of less than 0.0002 m3.

164. The apparatus according to claim 117, wherein the remote part of the movement restriction device has a volume between 0.0001 and 0.001 m3.

165. The apparatus according to claim 117, wherein the distal portion of the movement restriction device has a circumference of at least 120 mm.

166. The apparatus according to claim 117, wherein the distal portion of the movement restriction device has a circumference of at least 150 mm.

167. The apparatus according to claim 117, wherein the distal portion of the movement restriction device has a circumference of at least 180 mm.

168. The apparatus according to claim 117, wherein the distal portion of the movement restriction device has a circumference of at least 220 mm.

169. The apparatus according to claim 117, wherein at least a portion of the distal portion of the movement restriction device comprises a flexible, non-elastic material.

170. The apparatus according to claim 117, further comprising a fixation device adapted to be involved in securing the distal portion of the movement restriction device to the stomach wall.

171. The apparatus according to claim 117, further comprising two or more fixation devices adapted to be involved in securing the distal portion of the movement restriction device to the stomach wall.

172. The apparatus according to claim 117, wherein the distal portion of the motion restriction device comprises a holding device adapted to be held by an instrument and simplify the implantation of the device.

173. The apparatus according to claim 117, wherein the remote part of the movement restriction device comprises two or more maintenance devices adapted to be maintained by an instrument and simplify the implantation of the device.

174. The apparatus according to claim 117, wherein the distal portion of the movement restriction device comprises an inflatable chamber, further comprising at least one tube connected to the device for supplying the fluid to the chamber.

175. The apparatus according to claim 174, further comprising an injection orifice connectable with the tube.

176. The apparatus according to claim 117, wherein the distal portion of the motion restriction device has a maximum circumference as observed in a plane perpendicular to an axis through the device, and where the circumferences of the device as observed in another planes perpendicular to the axis are equal to the maximum circumference or decrease as observed along the axis in the direction of the maximum circumference.

177. The apparatus according to claim 117, wherein the circumference of the distal portion of the motion restriction device as observed in a plane perpendicular to an axis through the device increases and decreases at least twice as the plane moves along the axis, or decreases and increases at least once as the plane moves along the axis.

178. The apparatus according to claim 127, wherein the at least one layer comprises a layer of silicon.

179. The apparatus according to claim 127, wherein the at least one layer comprises a metal layer.

180. The apparatus according to claim 179, wherein the metallic layer comprises any of gold, silver, and titanium, or a combination thereof.

181. The apparatus according to claim 127, wherein the at least one layer comprises a layer of Teflon.

182. The apparatus for treating a reflux disease and obesity according to claim 1, wherein the movement restriction device comprises a stretching device comprising at least one operable stretching device implantable in an obese patient and adapted to stretch a portion of the stomach wall of the patient and an operating device for operating the stretching device when it is implanted to stretch the portion of the stomach wall such that satiety is formed.

183. The apparatus according to claim 182, at least one of the distant and proximal part of the movement restriction device comprises in the least part of an operable stretching device implantable in the patient and adapted to stretch a portion of the wall of the patient. stomach of the patient, and an implantable control unit for automatically controlling the operable stretching device, when the control unit and the stretching device are implanted, to stretch the portion of the stomach wall in relation to the patient eating such that satiety is formed.

184. The apparatus for treating a reflux disease and obesity according to claim 117, wherein at least one of the remote and proximal part of the movement restriction device comprises a stretching device comprising at least one operable stretching device. implantable in an obese patient and adapted to stretch a portion of the patient's stomach wall, wherein the stretching device comprising an expandable stretching reservoir; and an operating device for operating the stretching device when implanted to stretch the portion of the stomach wall, wherein the distal portion of the movement restriction device is inflatable and in fluid connection with the stretch reservoir, wherein the operating device comprises a pump for pumping the fluid between the main reservoir and the stretching reservoir for stretching the portion of the stomach wall such that satiety is formed.

185. The apparatus according to claim 184, comprising a control device for controlling the stretching of the device that includes the pump.

186. The apparatus according to claim 185, wherein the control device comprises a wireless remote control adapted to control the stretching device from the exterior of a patient's body.

187. The apparatus according to claim 186, wherein the control device comprises a subcutaneously placed switch or reservoir adapted to control the stretching device from the exterior of a patient's body.

188. The apparatus according to claim 186, wherein the control device comprising an implantable control unit for controlling the stretching device.

189. The apparatus according to claim 188, comprising a sensor or sensing device adapted to be implanted in the patient's body, wherein the implantable control unit is adapted to control the stretching device of the interior of a patient's body using the information of a sensor or the sensing device, adapted to the sense, direct or indirect, the food intake of the patient.

190. The apparatus according to claim 117, wherein the distal portion of the movement restriction device comprises a main volume filling reservoir, and a stretching device comprising at least one operable stretch device implantable in an obese patient and adapted to stretch a portion of the wall of the patient's stomach, wherein the stretching device comprising an expandable reservoir, adapted to be invaginate in the wall of the stomach to the upper part of the stomach, greater than principal the distal part of the device restriction of movement when the patient is standing, where the distant part of the movement restriction device is inflatable and in fluid connection with the deposit of stretch, contractions where normal of the stomach wall, food intake Related to, causing the fluid to flow from the inferior invaginated primary volume filling reservoir positioned in the wall of the stomach adapted to cause the stretching reservoir to stretch the portion of the stomach wall such that satiety is formed.

191. The apparatus according to claim 190, wherein fluid connection between the main volume filling reservoir and the stretch reservoir comprises a check valve.

192. The apparatus according to claim 191, wherein fluid connection. between the main volume filling tank and the stretching tank comprises a release function adapted to release the volume in the stretching tank back to the main volume filling tank.

193. The apparatus according to claim 192, wherein the release function comprises fluid return connection of a substantially smaller area than fluid connection, to slowly release the back fluid to the main volume reservoir of the reservoir of stretch to release the stretch of the stomach wall portion.

194. The apparatus according to claim 190, comprising a control device Additional manual comprising a subcutaneously positioned reservoir adapted to control the stretching device from the exterior of a patient's body to further affect the stretching device to stretch the portion of the stomach wall.

195. The apparatus according to claim 117, comprising a main volume filling reservoir adapted to be inflatable, the distal portion of the movement restriction device further comprising an expandable structure, adapted to expand, when the distal portion of the device Restriction of movement is invaginated in the wall of the stomach, where the structure comprising an adapted bellows takes into account the fibrosis surrounding the device following the implant, such that the movement of the. bellows is substantially unaffected by fibrosis.

196. An apparatus according to claim 117, wherein the distal portion of the movement restriction device comprises a stretching device comprising at least one operable stretching device implantable in an obese patient and adapted to stretch a portion of the wall of the patient. stomach of the patient, and where the stretching device comprising an expandable structure, adapted to multiply and stretch the portion of the stomach wall when the device is invaginated in the wall of the stomach, and where the structure comprises a special bellows adapted to take into account the fibrosis surrounding the device following the implant, such that the movement of the bellows is substantially unaffected by fibrosis.

197. The apparatus according to claim 196, further comprising an operating device for operating the stretching device when implanted to stretch the portion of the stomach wall such that satiety is formed.

198. The apparatus according to claim 196, wherein the distal portion of the movement restriction device comprises an implantable control unit for automatically controlling the operable stretching device, stretching the portion of the stomach wall relative to the patient eating such that satiety is formed.

199. The apparatus according to claim 198 further comprising a wireless remote control adapted to be controlled by the control unit from the outside of a patient's body.

200. The apparatus according to claim 198, wherein the control unit comprising a subcutaneously placed switch or reservoir adapted to control the device for stretching the outside of a patient's body.

201. The apparatus according to claim 198 wherein the control unit comprises an implantable control unit for controlling the stretching device.

202. The apparatus according to any one of claim 201, comprising a sensor or sensing device adapted to be implanted in the patient's body, wherein the implantable control unit is adapted to control the stretching device of the interior of the body of the patient. a patient using information from a sensor or sensing device, adapted to the direct or indirect sense of the patient's food intake.

203. The apparatus according to any one of claim 117, wherein at least one of the remote and proximal part of the motion restricting device further comprises a stretching device comprising three or more mechanical parts coupled with different parts of the wall of the stomach, one part each, where the coupling includes suturing or stapling to the stomach wall or invaginating the mechanical parts in the part of the stomach wall with sutures from stomach to stomach, where the three or more mechanical parts they adapt to move in relation to each other adapted to stretch three different portions of the wall, the additionally adapted stretching device has portions of the wall s drawn indistinctly from each other regardless of the force used to stretch the portion of the wall of the stomach as well as periods of time applied to the wall. stretch, and when the stretch is applied.

204. The apparatus according to claim 117, wherein at least one of the remote and proximal part of the movement restriction device further comprises a stretching device comprising two or more hydraulic parts coupled with different parts of the stomach wall, one part each, wherein the coupling includes suturing or stapling the hydraulic part to the wall of the stomach or invaginating the hydraulic parts in the part of the wall of the stomach, with sutures from stomach to stomach, wherein the two or more parts hydraulic are adapted to move relative to each other adapted to stretch three different portions of the wall, the additionally adapted stretching device has portions of the wall s drawn indistinctly from each other with reference to; force used to stretch the portion of the stomach wall as well as stretch periods, and when stretching is applied.

205. The apparatus to treat according to any according to claim 117, wherein at least one of the remote and proximal part of the movement restriction device further comprises a stretching device engaged with a part of the stomach wall, which includes suturing or stapling the device Stretching to the wall of the stomach or invaginating the stretching device in the part of the stomach wall, with sutures from stomach to stomach, wherein the stretching device is further adapted to stretch a portion control of the stomach wall; force used to stretch the portion of the stomach wall as well as stretch periods, and when stretching is applied.

206. The apparatus according to claim 117, wherein at least one of the remote and proximal part of the movement restriction device further comprises a stretching device comprising two parts coupled with different parts of the stomach wall, one part each one, wherein the coupling includes suturing or stapling the parts to the stomach wall or invaginating the parts in the part of the stomach wall, with sutures from stomach to stomach, wherein the stretching device additionally adapted to stretch different portions of the wall indistinctly between themselves control; force used to stretch the portion of the stomach wall as well as stretch periods, and when stretching is applied.

207. The apparatus according to claim 117, wherein at least one of the remote and proximal part of the movement restriction device further comprises a control device comprising an external control unit for controlling the remote part of the restriction device of movement from the outside of a patient's body.

208. The device according to claim 207, wherein the external control unit comprises a wireless remote control adapted to control the device from the exterior of a patient's body.

209. The device according to claim 208, wherein the control device comprises a subcutaneously placed switch or reservoir adapted to control the distal portion of the movement restriction device outside of a patient's body.

210. The apparatus according to claim 207 further comprises a sensor or sensing device adapted to be implanted in the body of the patient, wherein the control device is adapted to control the device inside a patient's body using information from a sensor or sensing device, adapted to the direct or indirect sense of the patient's food intake.

211. The apparatus according to claim 1, wherein the external surface of the movement restriction device includes a biocompatible material.

212. The apparatus according to claim 1 or 117, wherein both the distal and proximal part of the movement restriction device is adapted to be placed within the stomach through a gastroscopic instrument.

213. The apparatus according to claim 117, wherein the portions of the stomach wall are fixed together so as to invaginate the inner movement restriction device 1 placed from the wall of the patient's stomach.

214. The apparatus according to claim 117, wherein the portions of the stomach wall are set together tan a to invaginate at least the distal portion of the movement restriction device positioned outside the wall of the patient's stomach.

215. The apparatus according to claim 117, wherein at least the distal portion of the movement restriction device is adapted to be placed through the interior of the stomach and invaginated by the wall of the stomach outside the stomach wall.

216. The apparatus according to claim 117, wherein at least the distal portion of the movement restriction device is adapted to be placed across the outside of the stomach and invaginated by the stomach wall outside the stomach wall.

217. The apparatus according to claim 117, wherein the distal portion of the movement restriction device comprises at least two interconnectable portions adapted to be placed through the interior of the stomach and invaginated by the wall of the stomach outside the stomach wall. , as separate portions.

218. The apparatus according to claim 117, wherein the distal portion of the movement restriction device comprises at least two interconnectable portions adapted to be placed across the outside of the stomach and invaginated by the stomach wall outside of the stomach wall. , as separate portions.

219. The apparatus in accordance with claim 117, wherein at least the distal portion of the movement restriction device is adapted to be placed through the interior of the stomach and invaginated by the stomach wall inside the stomach wall.

220. The apparatus according to claim 117, wherein at least the distal portion of the movement restriction device is adapted to be placed across the outside of the stomach and invaginated by the stomach wall inside the stomach wall.

221. The apparatus according to claim 117, wherein the distal portion of the movement restriction device comprises at least two interconnectable portions adapted to be placed through the interior of the stomach and invaginated by the wall of the stomach inside the wall. of the stomach, as separate portions.

222. The apparatus according to claim 117, wherein the distal portion of the movement restriction device comprises at least two interconnectable portions adapted to be placed across the outside of the stomach and invaginated by the stomach wall inside the wall of the stomach. stomach, as separate portions.

223. The apparatus according to claim 1 or 117 comprising: two or more segments of the motion restriction device adapted to be assembled to an implantable assembled motion restriction device of a controlled size involving at least the proximal portion of the device of motion restriction, wherein the assembled motion restricting device is adapted to be supported with at least a portion of its outer surface against the fundus wall of the patient's stomach, in a position between the patient's diaphragm and the patient's wall. fundus, such that the movement of the cardiac notch of the patient's stomach towards the diaphragm of the patient is restricted, when the motion restriction device is implanted in the patient, to prevent the heart from sliding through the opening of the patient's diaphragm in the thorax of the patient, to maintain the support pressure against the muscle. Cardiac sphincter · exerted on the patient's abdomen.

224. An apparatus according to claim 223, wherein the assembled motion restricting device is adapted to disassemble in its segments if it maintains its implanted position of at least partially contacting the fundus wall of the stomach in a position between the diaphragm and the wall of the fundus.

225. An apparatus according to claim 223, wherein the assembled motion restriction device is adapted to be invaginated in the stomach wall, and wherein the assembled motion restriction device is adapted to disassemble in its segments if this maintains Your stomach position implanted penetration that includes the stomach wall to maintain a position within the stomach.

226. An apparatus according to claim 225, wherein the segments are adapted to pass through separately through the food passage, thus reducing the risk of causing obstruction / ileus in the patient's intestine.

227. An apparatus according to claim 223, wherein the segments of the movement restriction device are adapted to pass through a trocar, for the assembly and implantation of the movement restriction device in the abdominal cavity.

228. An apparatus according to claim 227, the segments of the movement restriction device have a flexible external shape adapted to pass through a trocar.

229. An apparatus in accordance with claim 223, wherein the segments of the movement restriction device are adapted to have a shape that allows them to be assembled in the movement restriction device, when implanted.

230. An apparatus according to claim 223, wherein the segments of the motion restriction device are hollow with a flexible external surface.

231. An apparatus according to claim 230, wherein the segments of the movement restriction device are adapted to be filled with at least one of a fluid a foam, a gel or a fluid that hardens to a solid material.

232. An apparatus according to claim 223, wherein the segments of the movement restriction device are solid.

233. An apparatus according to claim 223, wherein the segments of the movement restriction device are adapted to the temporal to maintain their assembled position.

2. 34. An apparatus according to claim 233, wherein the segments of the movement restriction device are adapted to permanently maintain their assembled position by the invaginated stomach wall.

235. An apparatus according to claim 233, wherein the segments of the movement restriction device are adapted to the temporal to maintain their assembled position by an adhesive.

236. An apparatus according to claim 223, wherein the segments are of the size allowed by the free through the gastrointestinal system.

237. An apparatus according to claim 223, wherein each segment is provided with at least one assembly element that sufficiently fits with at least one assembly element of another segment, then the segments fitting assembly elements can be assembled in the implantable movement restriction device.

238. An apparatus according to claim 237, wherein the segments comprise a main part and a plurality of external parts.

239. An apparatus according to claim 237 wherein the assembly element is selected from tabs that fit sufficiently and grooves.

240. An apparatus according to claim 238, wherein the main part is adapted to receive and assemble the external elements in a Implantable movement restriction device.

241. An apparatus according to claim 239, wherein the main part makes to adapt assembly slots to receive corresponding assembly tabs of the external parts when assembling the motion restriction device.

242. An apparatus according to claim 241 wherein the slots are distributed around the outer peripheral area of the main part.

243. An apparatus according to any of claims 223 to 242, wherein the apparatus further comprises a guiding device operable to assemble the segments of the movement restriction device to an implantable movement restriction device.

244. An apparatus according to claim 243, wherein the guide device is an operating wire functionally connected to the segments.

245. An apparatus according to claim 244, wherein the operating wire is made of a material that is biodegradable in contact with the body fluid in the abdominal cavity to support the dismounting of the movement restriction device in its segments.

246. An apparatus in accordance with Claim 243, wherein an operation wire is connected to the main part and to the external parts then the external parts can be sequentially assembled to the main part to assemble the motion restriction device.

247. An apparatus according to claim 246, wherein the operating wire is connected to the assembly flanges of the external part.

248. An apparatus according to claim 246, wherein the main part is provided with at least one operating channel for receiving the operating wire.

249. An apparatus according to claim 248, wherein the each external part is connected to two operating channels by the operating wire.

250. An apparatus according to claim 249, wherein a first operating channel has a first hole in a terminal surface of the main part and a second hole in a first slot of the main part, then when displacing the operating wire received in the first part. first operating channel in a direction of the terminal surface, a first external part is assembled to the main part.

251. An apparatus in accordance with claim 250, wherein a second operating channel has two holes in a second slot of the main part, then when displacing the operating wire connected with the first cannel operation in a directed terminal surface, a second external part is assembled to the main part

252. An apparatus according to claim 251, having three or more external parts assembled to slots designated from the main part with the operating wire through the operating channels having holes in each designated slot of the main part.

253. An apparatus according to claim 251, wherein the operating wire protrudes from the first channel hole then this can be operated with an instrument to move the operating wire and a first external element so its adjustments of the assembly flange with its first assembly slot designated on the main element, and in a predetermined sequence in the same manner as it displaces the remaining external elements to assemble the implantable movement restriction device.

254. An apparatus according to claim 223, comprising more than three segments of the movement restriction device.

255. The apparatus according to claim 1 or 223, further comprising an implantable stimulation device which, when implanted in the patient, sends the stimulation pulses to the cardiac sphincter muscle to stimulate the cardia sphincter muscle and thus further Cardiac sphincter to prevent further reflux disease.

256. The apparatus according to claim 255, wherein the stimulation device comprises at least one conductor and at least one electrode which, when implanted in the patient, receives stimulation pulses and applies to the cardiac sphincter muscle to thereby stimulate the Cardiac sphincter muscle.

257. The apparatus according to claim 256, wherein the stimulation device sends the stimulation pulses as the train of pulses, and where the train of pulses repeats with a time of rest between each pulse the train.

258. The apparatus according to claim 257, wherein the stimulation device sends several pulse trains in a row followed by a longer rest time than this between the pulse trains to leave the remaining muscle that still keeps the cardia sphincter closed.

259. The apparatus in accordance with claim 257, wherein, the stimulation device sends the stimulation pulses as a train of pulses, and where the train of pulses repeats with a rest time between them, the rest time that extends the rest between each pulse in the train of pulses.

260. The apparatus according to claim 256, wherein the stimulation device comprises an electronic circuit and an energy source.

261. The apparatus according to claim 223, wherein the segments of the movement restriction device are changeable to assume a thin shape having a diameter smaller than that of a trocar for laparoscopic use, whereby the body segment when Changes to the thin form can be pushed or removed through the trocar.

262. The apparatus according to claim 223, wherein the body comprises a flexible outer wall defining a fluid or gel filled chamber, allowing the body to pass through a trocar for laparoscopic use.

263. The apparatus according to claim 223, wherein at least one segment is hollow, comprises at least one chamber with an injection orifice, and the chamber of the body is filled with a fluid through the injection orifice.

264. The apparatus according to claim 223, wherein the segments comprise an elastic compressible material, allowing the body to pass through a trocar for laparoscopic use.

265. The apparatus according to claim 223, wherein the segments are made of a material softer than 25 Shore.

266. The apparatus according to claim 223, wherein the segments are made of a softer material than 15 Shore.

267. The apparatus according to claim 223, wherein the segments when assembled comprise an external wall that substantially takes the form of a ball.

268. The apparatus according to claim 223, wherein at least one of the segments comprises at least one support device adapted to be used to push or withdraw the segments through a trocar for laparoscopic use.

269. The apparatus according to claim 268, wherein the holding device is adapted to maintain an extension of at least one of the segments that is adapted to be maintained by a surgical instrument.

270. The apparatus in accordance with claim 268, wherein the holding device is adapted to maintain a thread or band inserted through the holding device.

271. The apparatus according to claim 268, wherein the assembled movement restriction device comprises an external wall and the support device is at least partly placed inside the external wall of the body.

272. The apparatus according to claim 1 or 117 or 223, further comprising an adjustment device for adjusting the size and / or shape of the movement restriction device.

273. The apparatus according to claim 272, wherein the size of the movement restriction device is hydraulically adjustable, and wherein the adjustment device comprises a reservoir of hydraulic fluid which, when implanted in the patient, is connected to the body, and where the body size is non-invasively regulated by the mobile hydraulic fluid reservoir to adjust the amount of hydraulic fluid supplied to the body, thus adjusting the body size.

274. The apparatus according to claim 273 further comprising a hydraulic regulating device comprising at least one chamber which, when implanted in the patient, is invaginates in the wall of the patient's stomach with the body and connected to the body, and where the amount of hydraulic fluid contained in the body is non-invasively regulated by distributing the fluid between the hydraulic reservoir and the at least one chamber.

275. The apparatus according to claim 274, wherein the at least one chamber is, when implanted in the patient, filled with the hydraulic fluid using a pump in the reservoir to stretch the fundus wall to create satiety in the patient.

276. The apparatus according to claim 272, wherein the adjusting device further comprises an inverse servomechanism comprising three reservoirs adjustable with the hydraulic fluid, wherein a small volume of fluid in a first reservoir placed subcutaneously, the part of a first closed system that includes a second tank, is compressed with a high power per unit area to move a small volume of hydraulic fluid, and where the second tank affects a larger volume of hydraulic fluid in a third tank, the third tank that is the part of a second closed system having the volume greater than the first reservoir, thereby creating a movement of a larger total volume of the hydraulic fluid with less force per unit area.

277. The device according to claim 272, further comprising a wireless remote control, wherein the motion restriction device, when implanted in the patient, is non-invasively regulated by the wireless remote control.

278. The apparatus in accordance with the indication 272, further comprising a power source that drives the motion restricting device to be usable, when implanted in the patient.

279. The apparatus according to claim 278, wherein the energy source comprises an internal energy source implantable in the patient.

280. The apparatus according to claim 278, wherein the energy source comprises an external energy source that transmits the wireless energy.

281. The apparatus according to claim 280, further comprising an internal energy source implantable in the patient ie when implanted in the patient, chargeable by the wireless energy transmitted by the external energy source.

282. The apparatus according to claim 277, wherein the wireless remote control comprises at least one external signal transmitter and receiver, further comprising a signal receiver internal and transmitter implantable in the patient to receive signals transmitted by the external signal transmitter and send feedback signals back to the remote control.

283. The apparatus according to claim 277, wherein the wireless control signal comprises a magnetic or electric field, or a magnetic and electric field in combination.

284. The apparatus according to claim 1 or 272, further comprising a wireless energy transmitter for non-invasively activating any part of the apparatus in need of energy supplementation.

285. The apparatus according to claim 284, wherein the energy transmitter transmits the energy at least one wireless energy signal.

286. The apparatus according to claim 284, wherein the wireless energy comprises a wave signal or a field.

287. The apparatus according to claim 286, wherein the wave signal is selected from the group comprising a sound wave signal, an ultrasound wave signal, an electromagnetic wave signal, an infrared light signal, a signal visible light, a light ultraviolet signal, a laser light signal, a microwave signal, a radio wave signal, an x-ray radiation signal and a gamma-ray signal.

288. The apparatus according to claim 286, wherein the wireless energy signal comprises a magnetic or electric field, or a magnetic and electric field in combination.

289. The apparatus according to claim 286, further comprising an implantable accumulator and an energy transforming device that transforms wireless energy into electrical energy, wherein electric power is used at least in part to charge the accumulator.

290. The apparatus according to claim 1 or 272, further comprising a sensor that detects a parameter.

291. The apparatus according to claim 290, wherein the parameter is a functional parameter.

292. The apparatus according to claim 291, wherein the functional parameter is correlated with a wireless transfer of energy to charge an internal energy source implantable in the patient.

293. The apparatus according to claim 291 or 292, further comprising a feedback device which, when implanted in the patient, sends the feedback information from inside a patient's body to the outside thereof, the feedback information that is relates to the functional parameter.

294. The apparatus according to claim 291, further comprising an implantable internal control unit for controlling the motion restriction device in response to the sensor sensing the functional parameter.

295. The apparatus according to claim 290, wherein the parameter is a physical parameter of the patient.

296. The apparatus according to claim 295, wherein the sensor for detecting the physical parameter is a pressure sensor.

297. The apparatus according to claim 295, wherein the sensor for detecting the physical parameter is a motility sensor.

298. The apparatus according to claim 295, further comprising an implantable internal control unit for controlling the motion restriction device in response to the sensor that detects the physical parameter.

299. The apparatus according to claim 1 or 272, further comprising an operating device for operating the motion restriction device in order to control its size and / or shape.

300. The apparatus according to claim 299, wherein the operating device comprises a motor or a pump.

301. The apparatus according to claim 1 or 272, wherein the motion restriction device is further adapted to receive the wireless energy, wherein the wireless energy energy is used the operating device to form the kinetic energy for the operation of the motion restriction device.

302. The apparatus according to claim 301, wherein the wireless energy is directly used, drives the operating device to form the kinetic energy for the operation of the motion restriction device, since the wireless energy is transmitted by the transmission device of the device. energy.

303. The apparatus according to claim 301, wherein the wireless energy, comprises a wave signal is selected from the group comprising a sound wave signal, an ultrasound wave signal, an electromagnetic wave signal, an infrared light signal, a visible light signal, a light ultraviolet signal, a signal of laser light, a microwave signal, a radio wave signal, an x-ray radiation signal and a gamma-ray signal.

304. The apparatus according to claim 301, wherein the wireless energy signal comprises a magnetic or electric field, or a magnetic and electric field in combination.

305. The apparatus according to claim 1 or 272, further comprising implantable electrical components that include at least one voltage level guard.

306. The apparatus according to claim 1 or 272, further comprising implantable electrical components that include at least one constant current guard.

307. The apparatus according to claim 301, further comprising an energy transforming device for transforming the wireless energy to electrical energy, wherein the electrical energy is used directly drive the operating device to form the kinetic energy for the operation of the volume filler device, since the wireless energy is transmitted by the energy transmission device.

308. The apparatus according to claim 1, wherein the motion restriction device has a circumference as observed in a plane perpendicular to an axis through the body, and where the circumference constantly increases or remains constant as the axis of a first valuation criterion of the axis to an intermediate point with a maximum, and the circumference constantly decreases or remains constant when in motion from the intermediate point to a second endpoint of the axis.

309. The apparatus according to claim 1, wherein the motion restriction device has a circumference as observed in a plane perpendicular to an axis through the body, and where the circumference constantly increases or remains constant as the axis of a first evaluation criterion of the axis to a first intermediate point with a first maximum, the circumference constantly decreases or remains constant when in movement from the first intermediate point to a second intermediate point with first minimum, the circumference constantly increases or remains constant as the axis of the second intermediate point of the axis to a third intermediate point with a second maximum, and the circumference constantly decreases or remains constant when in motion from the third intermediate point to a second endpoint of the axis.

310. An apparatus according to any of claims 237 to 254, wherein the at least one assembly element immobilizes each of the segments of the movement restriction device to a main part along a first plane, and where the segments of the movement restriction device and the main part further comprise second assembly elements, which following the segment unit s and main part, immobilize each segment and main part along a second plane at an angle to the first plane.

311. An apparatus according to 310, wherein the first plane and the second plane is substantially perpendicular.

312. An apparatus according to claim 310, wherein the second assembly elements are coupling elements with coupling protuberances and cavities provided in the segments of the movement restriction device and the main part.

313. An apparatus according to claim 312, wherein the at least one element of The assembly also includes protuberances and cavities.

314. An apparatus according to claim 313, wherein the at least one assembly element comprises an assembly groove in the main part and an assembly flange in a segment, and wherein a coupling element comprises a protrusion in the groove and a cavity in the flange; or wherein the at least one assembly element comprises an assembly flange in the main part and an assembly groove in a segment, and wherein a coupling element comprises a protrusion in the groove and a cavity in the flange.

315. The apparatus according to claim 127, wherein at least one of the near and distant portions of the motion restricting device is provided with a plurality of layers.

316. The apparatus according to claim 315, comprising an outer surface layer of polyurethane, Teflon, or polytetrafluoroethylene, Parylene, silicone, metal, or a combination thereof.

317. The apparatus according to claim 315, comprising an inner surface layer of polyurethane, Teflon, or polytetrafluoroethylene, Parylene, silicone, metal, or a combination thereof.

318. The apparatus according to claim 315, comprising a surface layer of polytetrafluoroethylene and an outer layer of. the silicone

319. The apparatus according to claim 315 comprising an inner surface layer of polytetrafluoroethylene, an intermediate layer of the silicone, and an outer layer of Parile.no.

320. The apparatus according to claim 315, comprising an inner surface layer of the polyurethane and an outer layer of the silicone.

321. The apparatus according to claim 315, comprising an inner surface layer of the polyurethane, an intermediate layer of the silicone, and an outer layer of Parylene.

322. The apparatus according to claim 127, wherein at least one of the proximal and distal portions of the movement restriction device comprises an outer layer that includes a biocompatible material.

323. The apparatus according to claim 1, wherein at least one of the segments of the movement restriction device has the shape of a polyhedron.

324. The apparatus according to claim 323, wherein at least one of the segments of the motion restriction device has one of the following forms, tetrahedron, hexahedron, octahedron, dodecahedron and icosahedron.

325. The apparatus according to claim 1, comprising a friction enhancing material.

326. The apparatus according to claim 325, wherein the friction enhancing material is any of the following an adhesive and an adhesive.

327. The apparatus according to claim 1, wherein at least one of the segments of the movement restriction device has a surface with a rough texture.

328. The apparatus according to claim 1, comprising a friction reducing material of the external surface of the volume having device segments.

329. The apparatus according to claim 328, wherein the friction reducing material is a fluid that reduces friction between segments of the adjacent movement restriction device.

330. The apparatus according to claim 1, comprising a second segment of expandable motion restriction device for enclosing two or more first segments of the device movement restriction different from the second movement restriction device segment, wherein the second movement restriction device segment and the first segments of the movement restriction device together form the motion restriction device.

331. The apparatus according to claim 330, wherein the second movement restriction device segment comprises a friction reducing material of an internal surface thereof, the friction reducing material which is in contact with the first segments of the device restriction of movement, when it is implanted.

332. The apparatus according to claim 330, wherein the second segment of motion restriction device is adapted to be filled with a fluid to allow mutual movement between the first segments of the adjacent motion restriction device so that the shape of the movement restriction device adapts to the movements of the stomach wall, when the movement restriction device invaginates into a wall of the stomach.

333. The apparatus according to claim 330, wherein at least a portion of the wall of the second segment of motion restriction device is flexible.

334. The apparatus according to claim 330, wherein at least a portion of the wall the second segment wall of movement restriction device is stretchable.

335. The apparatus according to claim 332, wherein the fluid is isotonic or hypertonic.

336. The apparatus according to any of claims 1-335, wherein the segments of the movement restriction device are adapted to be inserted into a sachet formed by the part of a wall of the patient's stomach.

337. The apparatus according to claim 1, wherein the segments of the movement restriction device are adapted to be filled, directly or indirectly, in the sachet formed by the part of a wall of the patient's stomach through a tubular instrument.

338. The apparatus according to claim 336 or 337, wherein the motion restricting device comprises a fluid that solidifies.

339. The apparatus in accordance with Claim 338, wherein the apparatus comprises a conduit adapted to deliver the fluid that solidifies in the conduit pocket through.

340. The apparatus according to claim 1, wherein the plurality of segments of the motion restriction device is adapted to be interconnected to form the motion restriction device, after which the plurality of segments of the restriction device have been inserted. of movement in a human or artificial bag.

341. The apparatus according to claim 1, wherein at least one of the segments of the movement restriction device has the spherical shape.

342. The apparatus according to claim 1, wherein at least one of the segments of the motion restriction device has. at least one flat surface.

343. The apparatus according to claim 1, wherein the segments of the movement restriction device adapted to be assembled to an implantable movement restriction device.

344. The apparatus according to claim 1, wherein the segments of the movement restriction device are adapted to form a implantable motion restriction device of a controlled size.

3. 4. 5. A method for using an apparatus according to any of claims 1-344, wherein the method one or more of the following steps of the operational method: introduce an instrument in the narrowing, pass through the esophagus, placing an anvil or unit for administration of fixator members in the esophagus between the cardia and the level of the diaphragm, to engage in the fixation of the esophagus to the stomach tissue, to pass through his esophagus and also additionally down in the stomach, fill the stomach with gas to expand the stomach, suck the stomach fluid, observe in guiding vision when the instrument comprising a camera, attach the instrument to the stomach, create and suture at least one sachet of the stomach wall, filling at least one sachet with a fluid and / or volume filling device or two or more volume filling devices, administering a plurality of volume filling devices in the sachet formed in the stomach tissue through a tubular member, pass through the wall of the stomach with the instrument, pass through the wall of the stomach with the instrument to place a volume filling device outside the stomach wall, pass through the wall of the stomach with the instrument to place a permitting tube placement from a subcutaneous injection hole, place a subcutaneous injection hole, suture or staple the wall of the stomach from the inside of it to the esophagus, Suture or staple the wall of the stomach to the stomach wall from inside the stomach, couple the instrument with the esophagus, suturing or stapling a layer of stomach tissue to a layer of esophageal tissue, suturing or stapling two layers of stomach tissue to a layer of esophageal tissue, Suture or staple three layers of stomach tissue to a layer of esophageal tissue, suturing or stapling four layers of stomach tissue to a layer of esophageal tissue, suture or staple one or more layers of the stomach tissue at two or more positions in the esophageal tissue, the esophagus having a central axis of the esophagus, the esophagus which additionally has a substantially cylindrical internal and external surface extending radially. in relation to the central axis of the esophagus and where the stomach tissue is fixed to the esophageal tissue both at a first point along a first longitudinal axis of the esophageal surface, substantially parallel to the central axis of the esophagus and to a second point a along a second longitudinal axis of the surface of the esophagus, substantially parallel to the central axis of the esophagus, at a distance from the first longitudinal axis of the esophageal surface, radially relative to the central axis of the esophagus, supply fixation members by means of a unit placed on the instrument, penetrate at least one layer of stomach tissue and a layer of tissue of the esophagus with fixation members s, place the fixation members above the gastroesophageal junction to form a tunnel between the esophagus and stomach above the junction, place a part of the esophagus in the esophagus and a part of the stomach in the esophagus, place a fixing member substantially between the stomach and part of the esophagus, Insert the instrument into the main stomach cavity through the cardia and adapt it to direct the instrument in the cranial direction to reach a position of the unit above the joint, allowing in the tunnel a substantially unrestricted contraction and release of the closing sphincter muscle of the cardia placed at the junction, when the tunnel has been formed.

346. A method for using an apparatus according to any of claims 1-344, wherein the method one or more of the following steps of the operational method: cut the skin of a patient create a hole in the patient's abdominal wall introduce the instrument into the abdominal cavity opening through in the abdominal wall, attach the instrument to the stomach, remove the stomach wall to form at least one pre-shaped sachet of the stomach wall, hold the stomach wall to form at least one pre-shaped sachet of the stomach wall, suture or staple at least one pouch on the wall of the stomach, filling at least one sachet with a fluid and / or volume filling device or two or more volume filling devices, administering a plurality of volume filling devices in the sachet formed in the stomach tissue through a tubular member, pass through the stomach wall in the stomach with instrument, pass through the wall of the stomach with the instrument to place a volume filling device inside the stomach wall, pass through the wall of the stomach with the instrument to suture the wall of the stomach to the wall of the esophagus, place the volume filler device outside the stomach wall, invaginate the volume filler device in the wall of the stomach place a subcutaneous injection hole, suture or staple the wall of the stomach to the stomach wall from the outside of the stomach, suturing or stapling the wall of the stomach to the stomach wall from the outside of the stomach without penetrating the mucosa, Suture or staple two layers of stomach wall to one or two layers of stomach wall, dock, the instrument with the esophagus, hold both sides of the esophagus to attach an esophageal wall layer to the stomach tissue, hold both sides of the esophagus and the fundus wall of the stomach to attach an esophageal wall layer to one or two layers of stomach tissue, introducing a tube or a gastroscopic instrument into the esophagus comprising an anvil member or a fixation delivery member that involves in the attachment of the esophagus to the stomach, coordinating the position of the anvil member or a fixation supply member within the esophagus to hold the instrument around the esophagus, suturing or stapling a layer of stomach tissue to a layer of esophageal tissue, suturing or stapling two layers of stomach tissue to a layer of esophageal tissue, Suture or staple three layers of stomach tissue to a layer of esophageal tissue, suturing or stapling four layers of stomach tissue to a layer of esophageal tissue, stapling using staples of different stapling depths in different positions in a row of staples, staple from stomach to esophagus with a first depth of staple and staple from stomach to stomach with a second depth of staple smaller, stapling a pouch with sutures from stomach to stomach in a row of staples, which further comprises stapling the esophagus with staples of a greater depth included as a part of the staple row, suturing or stapling one or more layers of the stomach tissue to two or more positions in the esophageal tissue, the esophagus having a central axis of the esophagus, the esophagus having additionally an internal and external substantially cylindrical surface extending radially relative to the central axis of the esophagus and where the stomach tissue is fixed to the esophageal tissue both at a first point along a first longitudinal axis of the esophageal surface, substantially parallel to the central axis of the esophagus and to a second point along the a second longitudinal axis of the surface of the esophagus, substantially parallel to the central axis of the esophagus, at a distance from the first longitudinal axis of the esophageal surface, radially relative to the central axis of the esophagus, supply fixation members by means of a unit placed on the instrument, penetrate at least one layer of tissue from stomach and a tissue layer of the esophagus with fixation members, place the fixation members above the gastroesophageal junction to form a tunnel between the esophagus and stomach above the junction, allow in the tunnel a substantially unrestricted contraction and release of the closing sphincter muscle of the cardia placed at the junction, when the tunnel has been formed, place a part of the esophagus in the esophagus and a part of stomach in the stomach through an introduction into the stomach cavity, placing a fixation member substantially between the stomach and part of the esophagus, inserting the instrument into the main stomach cavity below the union and adapted to direct the instrument in the cranial direction to reach an assembly position above the joint, operating a joint comprised in the instrument, to allow the instrument to be inserted into the main stomach cavity by bending the joint in one direction to reach a position of the part of the unit in the esophagus above the joint.

347. A method for using an apparatus according to any of claims 1-344, wherein the The method comprises steps of the operational method one or more of the following steps of the laparoscopic operational method: cut the skin of a patient introduce a tube through the abdominal wall, fill with a fluid or gas the abdominal cavity, introduce two or more trocars in the abdominal cavity, introduce a camera in the abdominal cavity through one of the trocars, introduce the instrument into the abdominal cavity through a trocar, attach the instrument to the stomach, remove the stomach wall to form at least one pre-shaped sachet of the stomach wall, hold the stomach wall to form at least one pre-shaped sachet of the stomach wall, suture or staple at least one pouch on the wall of the stomach, filling at least one sachet with a fluid and / or a volume filling device or two or more volume filling devices, administering a plurality of volume filling devices in the sachet formed in the stomach tissue through a tubular member, pass through the stomach wall in the stomach with instrument, pass through the wall of the stomach with the instrument to place a volume filling device inside the stomach wall, pass through the wall of the stomach with the instrument to suture the wall of the stomach to the wall of the esophagus, place the volume filler device outside the stomach wall, invaginate the volume filler device in the wall of the stomach place a subcutaneous injection hole, suture or staple the wall of the stomach to the stomach wall from the outside of the stomach, Suture or staple two layers of stomach wall to one or two layers of stomach wall, suturing or stapling the wall of the stomach to the stomach wall from the outside of the stomach without penetrating the mucosa, couple the instrument with the esophagus, hold both sides of the esophagus to attach an esophageal wall layer to the stomach tissue, hold both sides of the esophagus and the fundus wall of the stomach to fix a layer of esophageal wall to one or two layers of stomach tissue, introducing a tube or a gastroscopic instrument into the esophagus comprising an anvil member or a fixation delivery member that involves in the attachment of the esophagus to the stomach, coordinating the position of the anvil member or a fixation supply member within the esophagus to hold the instrument around the esophagus, suturing or stapling a layer of stomach tissue to a layer of esophageal tissue, suturing or stapling two layers of stomach tissue to a layer of esophageal tissue, Suture or staple three layers of stomach tissue to a layer of esophageal tissue, suturing or stapling four layers of stomach tissue to a layer of esophageal tissue, stapling using staples of different stapling depths in different positions in a row of staples, staple from stomach to esophagus with a first depth of staple and staple from stomach to stomach with a second depth of staple smaller, stapling a pouch with sutures from stomach to stomach in a row of staples, which additionally comprises stapling the esophagus with staples of a greater depth included as a part of the staple row, suturing or stapling one or more layers of the stomach tissue to two or more positions in the esophageal tissue, the esophagus having a central axis of the esophagus, the esophagus having additionally an internal and external substantially cylindrical surface extending radially relative to the central axis of the esophagus and where the stomach tissue is fixed to the esophageal tissue both at a first point along a first longitudinal axis of the esophageal surface, substantially parallel to the central axis of the esophagus and to a second point along a second longitudinal axis of the surface of the esophagus, substantially parallel to the central axis of the esophagus, at a distance from the first longitudinal axis of the esophageal surface, radially relative to the central axis of the esophagus, fixing members that they administer by means of a unit placed in the instrument, penetrate at least one layer of stomach tissue and a layer of tissue of the esophagus with fixation members s, place the fixation members above the gastroesophageal junction to form a tunnel between the esophagus and stomach above the junction, allow a shrinkage in the tunnel substantially unrestricted and release of the closing sphincter muscle of the cardia placed at the junction, when the tunnel has been formed, place a part of the esophagus in the esophagus and a part of stomach in the stomach through an introduction into the stomach cavity, placing a fixation member substantially between the stomach and part of the esophagus, inserting the instrument into the main stomach cavity below the union and adapted to direct the instrument in the cranial direction to reach an assembly position above the joint, operating a joint comprised in the instrument, to allow the instrument to be inserted into the main stomach cavity by bending the joint in one direction to reach a position of the part of the unit in the esophagus above the joint.