BRPI1007498A2 - obesity treatment - Google Patents

Abstract

TREATMENT OF OBESITY The present invention is related to an apparatus for treating obesity, which comprises a volume filling device formed of at least two segments that, after implantation, is placed leaning against the stomach wall of the patient, in order to in order to reduce the internal volume of the stomach, thereby affecting the patient's appetite.

Description

b 1/105 4 "OBESITY TREATMENT" m Technical Field]. The present invention relates to an apparatus, system and method for treating obesity.

Background of the Technique Obesity has been treated by means of gastric banding, that is, a band or band placed around the stomach to create a stoma, a restricted opening, to limit the flow of food that descends from the band. Also, it has been tried to use electrical stimulation of the stomach wall, in order to provoke in the

Patient with a feeling of satiety. R When the stomach is distended, the patient feels that the stomach is full. 15 Another way cited by the state of the art for treating obesity is to introduce a balloon-like object into the patient's stomach. In this way, the patient has a feeling of satiety much more quickly when eating, avoiding an excessive intake of food. However, these balloon-like objects mentioned by the state of the art are subject to stomach acids, which causes their destruction 20 in just two months of use. An example of an inflatable gastric device cited by the state of the art for treating obesity is disclosed in U.S. Patent No. 4,246,893, issued to Berson. In that document, an abdominal method is disclosed in which an inflatable balloon is surgically implanted in the patient's abdominal cavity, 25 adjacent to the stomach. An adjustment inlet is provided subcutaneously and the balloon is subsequently inflated by inserting a hypodermic needle through the patient's skin, at the adjustment inlet and with the introduction of a pressure fluid in the adjustment inlet, to pass into the balloon, in order to stretch the upper abdomen, compressing the stomach and thereby providing a feeling of satiety. 30

+ Summary of the Invention the objective of the present invention is to provide apparatus, system and methods for treating obesity, with improved long-term properties \

W duration. 5 This and other objectives are achieved using the apparatus described in the attached claims. In general terms, the present invention relates to an apparatus for treating obesity in a human or animal mammal patient, comprising two or more segments of a volume filling device, adapted to form an implantable volume filling device, preferably , of a controlled size. The volume filling device is adapted to be at least substantially sheathed by a wall portion

W of a patient's stomach, in which said volume filling device is adapted to be placed with its outer surface resting against the stomach wall, so that the volume of the food cavity is reduced in size, by 15 a volume that substantially exceeds the volume of the volume filling device when the volume filling device is sheathed in the stomach wall. The volume filling device is adapted for disassembly within its segments if the device leaves its sheathed and implanted position in the stomach and inadvertently penetrates the stomach wall, locating inside the stomach and including its penetration into the stomach wall , in order to maintain a position inside the stomach, in which said segments of the volume filling device are adapted to separately pass through the food, thereby reducing the risk of causing iliac obstruction in the intestines of the patients. Preferably, the volume filling device has a maximum circumference of at least 15 millimeters, more preferably, of at least 30 millimeters. Preferably, the segments of the volume filling device have at least a part of an external surface that includes a biocompatible material. When sheathing the volume filling device on the stomach wall, on the outside of the stomach, this device is protected from stomach acids and, therefore, will remain functioning for a long period of time. According to an alternative, the volume filling device is adapted to be placed inside the stomach, with its outer surface resting against the inside of the stomach wall, so that the volume of the cavity b 3/105 feeds already reduced in size by a volume that exceeds the volume of the volume filling device. The volume filling device is preferably adapted to be placed inside the stomach with a gastroscope.

According to another alternative, the volume filling device 5 is adapted to be placed outside the stomach wall, with its outer surface resting against the outside of the stomach wall, 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. Preferably, the volume filling device is adapted to be completely sheathed by the patient's stomach wall, and to be placed outside the stomach wall, by means of a gastroscopic instrument.

To this end, the segments of the volume filling device may comprise a fixing device, adapted to cooperate with a tightening instrument. Suitably, the volume filling device is adapted to be adjustable in a non-invasive manner, in the post-operative stage. Preferably, the volume filling device is adapted to disassemble within its segments, if it is allowed to be placed with its external surface resting against the stomach wall, that is, its implanted position, at least partially sheathed. The segments are preferably adapted to separately pass through the food passage path, thereby reducing the risk of causing iliac obstruction in the patient's intestine. The segments of the volume filling device can be adapted to pass through a trocar, for installation and implantation of said volume filling device within the abdominal cavity. The segments of the volume filling device may have a flexible external shape, adapted to pass through a trocar. The segments of the volume filling device can be adapted to have a shape that allows them to be installed inside the device or form said volume filling device, when implanted. In one embodiment, at least one of the segments of the volume filling device has a flexible outer surface. In one embodiment, at least one of the segments of the volume filling device comprises a rigid external surface. In one embodiment, at least one of the segments of the volume filling device is hollow, with a flexible outer surface. In

+ one embodiment, at least one of the segments of the volume filling device comprises a containment wall defining a chamber. So, at

W minus one of the segments of the volume filling device can be adapted

W to be filled with at least one of, a fluid, a foam, a gel or a fluid 5 that hardens to form a solid material. In one embodiment, the segments of the volume filling device comprise a homogeneous and / or solid material, for example, a solid body. In one embodiment, at least one of said segments comprises a flexible, non-elastic material. In one embodiment, at least one of said segments comprises an inflatable chamber and at least one tube 10 connected thereto, for supplementing fluid into the chamber. It is preferred that the segments of the volume filling device are adapted for

V are temporarily held in their installed position, preferably by the wall. sheathed stomach or, alternatively, by means of an adhesive. For its installation, the volume filling device is provided with at least one mounting element, which fits sufficiently with at least one mounting element from another segment, so that the segments by fitting the mounting elements installed inside the implantable volume filling device. Preferably, the segments for this purpose comprise a core part and a plurality of external parts 20 and, preferably, said at least one mounting element is selected from sufficiently engaging flanges and slots. The core part is adapted to receive and install the external elements within an implantable volume filling device and, preferably, the core part has mounting slots, adapted to receive corresponding mounting flanges from the external parts, 25 during installation of the volume filling device. In one embodiment, the slits are distributed around the outer perimeter of the core part. The external parts are then provided with flanges, which sufficiently adapt with the slots, for mounting the device. In another embodiment, said at least one mounting element immobilizes each of the segments of the volume filling device to a core part along a foreground when in motion, and in which the segments of the volume filling device and the core part further comprises a second mounting element, which after the assembly of said segments and the core part, immobilizes each segment and the core part along a second plane, making an angle with said first plane. Thus, for example, the first plane and the second plane can be substantially perpendicular. The second mounting element comprises leveling elements, preferably with leveling projections and recesses, provided in the segments of the volume filling device and in the core part, at the same time that said at least one mounting element comprises projections and recesses. Preferably, said at least one mounting element comprises a mounting slot in the core part and a mounting flange in a segment, and wherein a leveling element comprises a projection in said slot and a recess in said flange; or, alternatively, said at least one mounting element comprises a mounting flange in the core part and a mounting slot in a segment, and wherein a leveling element comprises a projection in said slot and a recess in said flange.

In a specific embodiment, the apparatus preferably further comprises a guide device, operable for mounting the segments of the volume filling device, so as to form a volume filling device. Preferably, the guiding device is an operating wire, operably connected to the segments. The operating wire can be made of a material that is biodegradable when in contact with the body fluid in the abdominal cavity, in order to facilitate the disassembly of the volume filling device in its segments. In order to assist the assembly procedure, each segment can be provided with at least one mounting element, which, sufficiently, fits at least with a mounting element of another segment, so that the segments by fitting of the mounting elements can be installed in the volume filling device or form the same. In one embodiment, the segments comprise a core part and a plurality of external parts and, in one embodiment, the mounting elements are selected from sufficiently fit flanges and slots. The core part is preferably adapted to receive and install the external elements within an implantable volume filling device. In one embodiment, the core part has mounting slots, adapted to receive corresponding mounting nanges from the external parts, when installing the volume filling device. Preferably, the slits are distributed around the outer peripheral area of the core part. The slots and flanges can be designed to have a loose fit, adapted to keep the segments together, when the volume filling device is in its implanted position, but it helps in disassembling the device if it inadvertently leaves that position, for example. example, to the stomach cavity. In such a case, the decomposition of the guiding device will also assist in disassembling the volume filling device in its segments, which are designed not to cause any obstruction or otherwise harm the patient.

In order to assemble the segments, the operating wire is connected to the core part and the external parts, so that the external parts can be sequentially mounted to the core part, to allow the assembly of the volume filling device. For this purpose, the operating wire is connected to the mounting flanges of the external part and, preferably, the core 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 orifice in an end surface of the core part and a second orifice in a first slot of the core part, so that when the operating wire received in said first operating channel is moved , in a direction of said end surface, a first outer part is mounted to said core part. A second operating channel has two holes in a second slot in the core part, so that when the operating wire connected to the first operating channel is moved, in the direction of said end surface, a second outer part is mounted to said part of core. Preferably, the guide wire projects from the first channel hole, so that it can be operated with an instrument to move the guide wire and a first external element, thus its mounting flange fits with its first projected mounting slot. in the core element, and in a predetermined sequence and in the same way, displacing the remaining external elements, in order to provide the assembly of the filling plant with an implantable volume. The segments may comprise three or more external parts assembled for the projected slits of the core part, with the guide wire through the operating channels having holes in each slot projected from said core part. In one embodiment, the volume filling device comprises a core part and four outer parts. However, other ways of projecting the segments within the present concept are feasible, as can be understood by experts skilled in the art. The volume filling device thus assembled can maintain a generally spherical shape, but, as will be described below, other shapes and additional operating elements will also form part of the present invention. The apparatus may comprise a fixing device, suitably two or more fixing devices, adapted to be involved in fixing the volume filling device to the stomach wall. The volume filling device, including at least one of its segments, may comprise a holding device, adapted to be supported by an instrument, suitably, two or more holding devices, in order to simplify the implantation of the device.

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

In one embodiment, the volume filling device including at least one of its segments is inflatable to an expanded state, comprising a confinement wall defining a chamber, in which the volume filling device is inflated with a gel or fluid, supplied inside the chamber. At least one tube can be connected to the volume filling device to supply gel or fluid to the chamber. An injection port that can be connected to the tube can be provided. Alternatively, the volume filling device or element can be provided with an inlet opening for a fluid or gel, which can be connected to a gastroscopic instrument, wherein the inlet opening comprises a fluid connection adapted to interconnect the inflatable device and the gastroscopic instrument.

The volume filling device may include a homogeneous material, such as a gel, having a Shore hardness value of less than 15. The device may also be a solid body. The volume filling device, including at least one of its segments, may comprise a rigid, elastic or flexible outer surface.

When the outer surface is rigid, it will be rigid enough to remain undeformed when subjected to forces created by stomach movements. The volume filling device may comprise a flexible non-elastic material.

According to a first general model of the volume filling device 5, the device has a maximum perimeter when viewed in a plane perpendicular to an axis of the device. The perimeter of the device when viewed in other planes perpendicular to said axis, is equal to the maximum perimeter or decreases when viewed along said axis, in the direction of the maximum perimeter. Thus, for example, the device may be substantially oval, spherical in shape or substantially egg shaped with a carved intermediate section, or curved egg type. According to a second general model of the device, the perimeter of the device, when viewed in a plane perpendicular to an axis of said device, increases and decreases at least twice, when the plane is displaced along said axis, or decreases and increases at least once, when the plane is moved along said axis. Thus, for example, the device can be substantially kidney shaped.

The volume filling device in yet another modality, presents a perimeter contour when seen in a plane perpendicular to an axis of the body, and in which the perimeter constantly increases or remains constant when it moves along said axis, from a first end point of said axis, to an intermediate point with a point of maximum, and the perimeter constantly decreases or remains constant when moving from said intermediate point to a second end point of said axis.

The volume filling device in yet another mode, has a perimeter, as seen in a plane perpendicular to an axis of the body, in which the perimeter constantly increases or remains constant when moving along said axis, from a first extreme point from said axis to a first intermediate point with a first maximum point, where the perimeter constantly decreases or remains constant when moving from said first intermediate point to a second intermediate point with a first minimum point, where the perimeter constantly increases or remains constant when moving along said axis, from said second intermediate point of said

Q 9/105 axis for a third intermediate point with a second point of maximum, and yet the perimeter constantly decreases or remains constant, when it moves from said third intermediate point to a second extreme point of said axis.

More embodiments of the invention will be described below. The volume filling device and / or one or more of the segments of the volume filling device may have an elongated, rounded and / or curved shape. The volume filling device has a perimeter of at least 30, 50, 80 120, 150, 180 or 220 mm. The volume filling device has a volume ranging from 0.0001 to 0.001 m ', or from 0.00001 to 0.001 m', or from 0.00001 to 0.0002 m '. The volume of the volume filling device volume, in yet another modality, presents a volume below 0.0002 m3.

The volume filling device may comprise at least two interconnectable portions, to be placed inside the stomach as separate portions. The volume filling device, including at least one of its segments, can comprise an electrical material, a biocompatible material and / or silicone. Suitably, the volume filling device is provided with at least one layer, such as, for example, a metal layer, a Parylene® layer, a polythetafluoroethylene layer or a polyurethane layer. The layers can 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 an outer surface layer of silicone, polyurethane, Teflon®, or polytetrafluoroethylene, metal, Parylene®, PTFE, or a combination thereof. The volume filling device may comprise an inner surface layer of silicone, polyurethane, Teflon®, or polytetrafluoroethylene, metal, Parylene®, PTFE, or a combination thereof. Other combinations include an internal surface layer of polytetrafluoroethylene and an external layer of silicone, an internal surface layer of polytetrafluoroethylene, an intermediate layer of silicone and an external layer of Parylene®, an internal surface layer of

% 10/105 0 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®. m The volume filling device, including at least one of its segments, can comprise a fluid, adapted to be transformed into the. 5 solid state or to a fixed form. This fluid can be liquid or isotonic polyurethane. The fluid can comprise large molecules, such as iodine molecules, to prevent eventual diffusion.

The volume filling device may have a maximum circumference of at least 50 mm, preferably at least 80 mm.

10 Suitably, the volume filling device can be deformed to a maximum diameter, so that it can be inserted into a laparoscopic trocar. »Preferably, the volume filling device is adapted for. be held in place by means of sutures or stomach-to-stomach connecting clips to sheath the device in the stomach wall. Advantageously, the volume filling device has a variable perimeter, so that it can be satisfactorily held in place, sheathed in the patient's stomach wall. Stomach-to-stomach sutures or staples can be provided with fixation portions that exhibit a structure adapted to be in contact with the stomach wall, to promote the growth of human tissue, to fix as a long-term placement, the volume filling device to the stomach wall. The structure may comprise a network type structure.

In an embodiment of the invention, the apparatus comprises a stretching device, placed 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, including at least one of its segments, is inflatable, the apparatus may comprise a fluid connection interconnecting the stretching device and the volume filling device.

In one embodiment, the apparatus comprises 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 to operate the stretching device when implanted, to stretch the portion of the stomach wall, so that a feeling of satiety is already created.

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 The control and the stretching device are implanted, to stretch the portion of the stomach wall, in connection with the patient's food, so that a feeling of satiety is created.

In one embodiment, the apparatus comprises at least one operable stretching device, implantable in an obese patient and adapted to stretch a portion of the patient's stomach wall, wherein said stretching device comprises an expandable stretching reservoir and a stretching device. operation to operate the implanted stretching device, to stretch the stomach wall portion, in which the volume filling device is inflatable and is in fluid connection with said stretching reservoir, wherein said operating device comprises a pump for pumping fluid between said main reservoir and said stretching reservoir, to stretch said stomach wall portion, so that a feeling of satiety is created. A control device can be provided to control said stretching device, including said pump. The control device may comprise a wireless remote control device, adapted to control the stretching device from outside the patient's body, or an implantable control unit to control said stretching device. Alternatively, the control device may comprise a switch placed subcutaneously, or a reservoir adapted to control the stretching device from outside the patient's body. A sensor or detection device to be implanted in the patient's body can be provided, wherein the implantable control unit is adapted to control the stretching device from inside the patient's body using information from said sensor or detection device, adapted for detect, directly or indirectly, the patient's food intake.

In one embodiment, the volume filling 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 stomach wall. of a patient, in which the stretching device comprises an expandable reservoir,

© 12/105 adapted to be sheathed in the stomach wall, in the upper part of the stomach, higher than the main inflatable volume filling device when the patient is standing, where the volume filling device is inflatable and it is in fluid connection with said stretching reservoir, in which 5 normal contractions of the stomach wall correlated to food intake cause the fluid to circulate from said sheathed main volume filling reservoir, placed in a lower position on the wall of the stomach, adapted to compel said stretching reservoir to stretch said portion of the stomach wall, so that a feeling of satiety is created. The fluid connection 10 between the main volume filling device reservoir and the stretching reservoir comprises a back pressure valve. The fluid connection between the main volume filling device reservoir and the stretching reservoir comprises a release function adapted to release the volume from the stretching reservoir back to the main volume filling device reservoir. Said release function may comprise a fluid return connection from an area substantially smaller than said fluid connection, to slowly return fluid to said reservoir of the main volume filling device, coming from said stretching reservoir, to release the said stretching of the stomach wall portion. An additional manual control device 20, comprising a reservoir placed subcutaneously, adapted to control the stretching device from outside the patient's body, can be provided to further affect the stretching device, to stretch the stomach wall portion.

In one embodiment, a reservoir of the main volume filling device, adapted to be inflatable, may be provided, wherein the volume filling device further comprises an expandable structure, adapted to expand when the device is sheathed in the stomach wall, wherein said structure comprises a bellows-like element, adapted to take into account the fibrosis surrounding the implanted device, so that the movement of the bellows is not substantially affected by said fibrosis. In one embodiment, the apparatus comprises a stretching device, which comprises at least one operable stretching device, implantable in an obese patient and adapted to stretch a portion of a patient's stomach wall, and wherein the stretching device comprises an expandable structure, adapted to expand and stretch the stomach wall portion when the device is sheathed in said stomach wall, wherein said structure comprises a special bellows-like element, adapted to take into account the fibrosis surrounding the device when implanted, so that the movement of the bellows-like element is not already substantially affected by said fibrosis. An operating device for operating the stretching device can be provided, to stretch the stomach wall portion, so that a feeling of satiety is created. The apparatus may comprise an implantable control unit, to automatically control the operable stretching device, when the control unit and the stretching device are implanted, to stretch the stomach wall portion in connection with the patient's food, so that a feeling of satiety is created.

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 a patient's stomach wall, so that a feeling of satiety is created . The control device may comprise a wireless remote control, adapted to control the stretching device from outside the patient's body, or an implantable control unit, to control said stretching device. Alternatively, said control device may comprise a switch placed subcutaneously, or a reservoir adapted to control the stretching device from outside the patient's body. A sensor or detection device, adapted to be implanted in the patient's body, can be provided, in which the implantable control unit is adapted to control q stretching device from inside the patient's body, using information from said sensor or detection device directly or indirectly, the patient's food intake.

In one embodiment, the apparatus further comprises a stretching device, comprising three or more mechanical parts individually connected to different parts of the stomach wall, wherein said engagement includes suturing or stapling to the stomach wall, or sheathing the mechanical parts in the stomach wall portion with stomach-to-stomach connecting sutures, where the three or more mechanical parts are adapted to move relatively with each other,

%

14/105 adapted to stretch three different wall portions, the stretching device being further adapted to have said wall portions stretched independently of each other, taking into account the force used to stretch the stomach wall portion, as well as, the periods of time when the stretch is applied, and when

5 stretching is applied.

In one embodiment, the apparatus further comprises a stretching device comprising two or more hydraulic parts, individually connected to different parts of the stomach wall, wherein said connection includes suturing or stapling of the hydraulic part to the stomach wall, or the

10 sheathing the hydraulic parts on the stomach wall portion with stomach-to-stomach connecting sutures, where the two or more hydraulic parts are adapted to move relatively to each other, adapted to stretch three different wall portions, the stretching device being still adapted to have said portions of wall stretched independently from each other, taking into account the

15 force used for stretching the portion of the stomach wall, as well as the time periods during which the stretching is applied and also when the stretching is applied.

In one embodiment, the device also comprises a stretching device, which is connected to a part of the stomach wall, including the

20 suturing or stapling the stretching device to the stomach wall, or sheathing the stretching device in the stomach wall portion with stomach-to-stomach sutures, wherein the stretching device is further adapted to stretch a portion of the stomach wall controlling the force used to stretch said portion of the stomach wall, as well as the time periods

25 stretch is applied and also when that stretch is applied.

In one embodiment, the apparatus further comprises a stretching device comprising two parts individually connected to different parts of the stomach wall, wherein said connection includes suturing or stapling the parts to the stomach wall, or sheathing the parts in the portion of wall of

Stomach with sutures connecting stomach to stomach, in which the stretching device is further adapted to have different portions of wall stretched independently of each other, controlling the force used to stretch said portion of stomach wall, as well as the periods of time when the stretch is applied and also when that stretch is applied. 6 In one embodiment, the device is also adapted for the treatment of reflux disease. For this purpose, the apparatus further comprises a device for filling

V 5 implantable volume, adapted to, at least partially, be sheathed by the wall of the patient's stomach, and having an external surface that includes a biocompatible material, in which a substantial part of the external surface of the volume filling device is adapted to lean against the stomach wall, without causing damage to it, in a position between the patient's diaphragm and at least a portion of the lower part of the sheathed stomach end wall, so that the movement of the cardiac incision is restricted. patient's stomach - towards his diahagma, when the volume filling device is sheathed, to thereby prevent the cardia from sliding through the patient's diahagma opening into his chest, in order to maintain pressure of support 15 against the sphincter muscle of the patient's cardia, exercised by the patient's abdomen, the volume filling device having a volume of at least 125 md and a perimeter at least 15 mrn.

In another modality, the device is also adapted for the treatment of reflux disease. For this purpose, the apparatus further comprises an implantable volume filling device, having an external surface that includes a biocompatible material, in which the movement restriction device is adapted to support with at least a part 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, so that the movement of the cardiac muscle of the patient's stomach 25 in the direction of his diaphragm is restricted when the movement restriction device it is implanted in the patient, in order to prevent the cardia from sliding through the opening of the patient's diaflagma into his chest, in order to maintain the support pressure against the patient's sphincter muscle in the patient's abdomen , the volume filling device having a volume of at least 125 md and a perimeter of at least 15 mm, and a fixing device adapted to hold the device positive volume filling in said position, when the volume filling device is implanted.

-)

%

10/165

In another modality, the device is also adapted to treat reflux disease.

For this purpose, the device further comprises an implantable movement restriction device, adapted to be at least partially sheathed by the patient's stomach wall, and having an external surface that includes a

5 biocompatible material, in which a substantial part of the external surface of the movement restriction device is adapted to rest against the stomach wall, without causing damage to it, in a position between the patient's diaphragm and at least a portion of the lower part of the sheathed stomach end wall, so that the movement of the cardiac incision of the patient's stomach is restricted

10 towards his diaphragm, when the movement restriction device is sheathed in the patient, to thereby prevent the cardia from sliding through the patient's diahagma opening into his chest, in order to maintain the supporting pressure against the sphincter muscle of the patient's cardia, exerted by the patient's abdomen, the movement restriction device having a volume of at least 125

15 md and a perimeter of at least 15 mm, further comprising 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, so that it is created a feeling of satiety.

In another modality, the device is also adapted to treat

Reflux.

For this purpose, the apparatus further comprises an implantable movement restriction device, having an external surface that includes a biocompatible material, in which the movement restriction device is adapted to support with at least a part of its external surface against the facing wall of the patient's stomach, in a position between the patient's diaphragm and the back wall,

25 so that the movement of the cardiac incision of the patient's stomach towards his diaphragm is restricted, when the movement restriction device is implanted in the patient, in order to prevent the cardia from sliding through the opening of the patient's diahagma into your chest, in order to maintain the pressure of support against the sphincter muscle of the patient’s cardia, exerted by the patient’s abdomen,

30 wherein the movement restriction device has a volume of at least 125 3 and a perimeter of at least 15 mm, and a fixture adapted to secure the movement restriction device in said position, when the movement restriction device The movement is implanted, further comprising a stretching device that comprises at least one operable stretching device, implantable in an obese patient and adapted to stretch a portion of the patient's wall.

F a patient's stomach, so that a feeling of satiety is already created. In one embodiment, the apparatus further comprises an external control unit * 5 to control the volume of the volume filling device from outside the patient's body. The external control unit may comprise a wireless remote control device, adapted to control the device from outside the patient's body. Alternatively, the external control unit may comprise a switch or reservoir placed subcutaneously, adapted to control the device from outside the patient's body. In one embodiment, the apparatus further comprises a sensor or - detection device, adapted to be implanted in the patient's body, when the implantable control unit is adapted to control the device from within the patient's body using information from said sensor or detection device, 15 adapted to detect, directly or indirectly, the patient's food intake.

According to another aspect of the present invention, there is provided an apparatus for treating obesity in an obese patient, having a stomach with a food cavity, the apparatus comprising at least one volume filling device, adapted to be at least partially sheathed by a portion of a patient's stomach wall, and having an outer surface that includes a biocompatible material, wherein the volume filling device is adapted to be placed inside the stomach, with the outer surface of the volume filling device leaning against the inside of the stomach wall, 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, the volume filling device having a maximum perimeter of at least minus 30 mm. In a preferred embodiment, the apparatus comprises at least one switch implantable in the patient to control the volume filling device manually and non-invasively. In another preferred embodiment, the apparatus comprises a wireless remote control device for non-invasively controlling the volume filling device.

% 18/105 0 In a preferred embodiment, the apparatus comprises a hydraulic operating device for operating the volume filling device.

W In one embodiment, the device comprises a motor or a pump to operate the volume filling device. . In one embodiment, the apparatus comprises an adjustment device to adjust the size and / or shape of the volume filling device, including at least one of its segments. The size of the volume filling device can be hydraulically adjustable, and the adjustment device comprises a reservoir of hydraulic fluid, which, when implanted in the patient, is connected to at least one of the segments of the volume filling device, and in that the size of the volume filling device is not non-intrusively regulated - by moving hydraulic fluid from the reservoir to at least one segment of the volume filling device, thereby adjusting the hair size. least one segment of the volume filling device. The apparatus may further comprise a hydraulic regulation device, which comprises at least one chamber, which when implanted in the patient is sheathed on the patient's stomach wall with the volume filling device, if available in connection with it, and wherein the amount of hydraulic fluid contained in at least one of the segments of the volume filling device is regulated non-invasively by the distribution fluid between the hydraulic reservoir and said at least one chamber. Preferably, said at least one chamber, when implanted in the patient, is filled with hydraulic fluid, using a pump in the reservoir, in order to stretch the wall of flow, to create a feeling of satiety in the patient. The adjustment device may further comprise a servomerse mechanism, 25 comprising three adjustable reservoirs with hydraulic fluid, in which a small volume of fluid in a first reservoir placed subcutaneously, forming part of a first closed system that includes a second reservoir, is compressed with a high force per unit area, to move a small volume of hydraulic fluid, and in which the second reservoir affects a greater volume of hydraulic fluid 30 in a third reservoir, the third reservoir being part of a second closed system, having a volume greater than that of the first reservoir, thus creating a movement of a greater total volume of hydraulic fluid, with less force intensity per unit area. The apparatus of the mode discussed can comprise a wireless remote control device, in which the volume filling device when implanted in the patient is regulated non-invasively by the wireless remote control device.

The apparatus of the modality discussed may further comprise a power source that drives the adjustable volume filling device.

5 when implanted in a patient.

The energy source preferably comprises an internal energy source implantable in the patient.

The power source may also comprise an external power source that transmits energy wirelessly.

The internal source of energy, when implanted in the patient, can be charged by the wireless energy transmitted by the external source of energy.

The wireless remote control device may comprise at least one external signal transmitter and receiver, further comprising a receiver and internal signal transmitter implantable in the patient, for receiving signals transmitted by the external signal transmitter and sending feedback signals. back to the remote.

The wireless control signal can comprise an electric field or a magnetic field, or a combination of an electric and magnetic field.

In one embodiment, the device comprises a wireless energy transmitter, to energize non-invasively any part of the device in need of energy supplementation.

The power transmitter preferably transmits power through at least one wireless power signal.

Preferably, the wireless energy comprises a signal or a wave field or the wireless energy signal can comprise an electric or magnetic field, or a combination of an electric and magnetic field.

The wave signal is preferably selected from the group consisting of: a sound wave signal, an ultrasonic wave signal, an electromagnetic wave signal, an infrared light signal, a visible light signal, an ultraviolet light, a laser light signal, a microwave signal, a radio wave signal, an X-ray radiation signal, and a gamma radiation signal.

The apparatus of this modality may further comprise an implantable accumulator, and an energy transformation device, which transforms wireless energy into electrical energy, in which electrical energy is used to at least partially charge the accumulator or to process any part energy consumption of the device, directly from the energy transformation device.

In one mode, the device comprises a sensor that detects a parameter, said parameter, which can be a functional parameter or a physical parameter

.

20/105 0 of the patient. The functional parameter is correlated to a wireless energy transfer, to charge an internal implantable energy source in the patient. The + device can also comprise a feedback device, which when implanted in the patient, sends feedback information from inside the patient's body to the

H 5 outside of it, the feedback information being correlated to the functional parameter. The apparatus may also comprise an internal implantable control unit for controlling the volume filling device in response to detection of the hnational parameter sensor. The sensor for detecting the physical parameter is a pressure sensor or a motion sensor. An implantable internal control unit 10 can control the device's volume filling device in response to detection of the physical parameter sensor. e In one embodiment, the device comprises an operating device

W to operate the volume filling device in order to control its size and / or its shape. To that end, the operating device may comprise a motor or a pump. In a device embodiment, the volume filling device is adapted to receive wireless energy, in which wireless energy is used to drive the operating device, in order to create kinetic energy for the operation of the filling device. volume. Wireless energy can, for example, be used 20 to directly drive the operating device, so as to create cmetic energy for the operation of the volume filling device, as the wireless energy is transmitted by the transmission device. power. The volume filling device can also be adapted to receive energy from an energy transformation device directly during wireless energy transfer, or from an energy accumulator, being rechargeable by wireless energy and the energy transformation device. energy. Wireless energy preferably comprises a wave signal that is selected from the group consisting of: a sound wave signal, an ultrasonic wave signal, an electromagnetic wave signal, an infrared light signal, an visible light, an ultraviolet light signal, a laser light signal, a 30 microwave signal, a radio wave signal, an X-ray radiation signal, and a gamma radiation signal. The wireless energy signal can also comprise an electric or magnetic field or a combination of an electric and magnetic field.

«21/105 a In one type of device, it also includes implantable electrical components, including at least one voltage level protector, or at least one constant current protector.

In a device mode, at least one of the segments of the

The volume filling device has at least one flat surface. Preferably, the segments of the volume filling device have the shape of a polyhedron, preferably one of the following shapes: tetrahedron, hexahedron, octahedron, dodecahedron and icosahedron.

In one embodiment of the apparatus, a friction enhancing material is provided. This increases the friction between adjacent segments of the volume filling device, thereby stabilizing the volume device. volume filling. This friction-enhancing material is preferably a glue

F or a sticker. Alternatively, at least one of the segments of the volume filling device has a rough textured surface.

15 In one type of device, at least one segment of the volume filling device has a spherical shape. Alternatively, the segment has at least one flat surface. In an alternative embodiment, the apparatus comprises a fluid to reduce friction between adjacent segments of the volume filling device.

20 In this way, the volume filling device can easily adapt its shape to the patient's body movements.

In one embodiment, the apparatus comprises a friction-reducing material on the outer surface of the segments of the volume filling device.

Such friction-reducing material may be a fluid that reduces the attack between adjacent segments 25 of the volume filling device. The apparatus may comprise a second segment of the expandable volume filling device, for including two or more first segments of the volume filling device, different from the second segment of the volume filling device, wherein the second segment of the filling device volume and the first segments of the volume filling device together form a volume filling device. In an alternative, the second segment of the volume filling device comprises a friction reducing material on an internal surface thereof, in which the friction reducing material is arranged in contact with the first segments of the volume filling device, when deployed. The second segment of the volume filling device can be adapted to be filled with a fluid, to allow mutual movement between the first 5 segments of the volume filling device, so that the shape of the volume filling device is adapted to the movements of the stomach wall when said volume filling device is sheathed in a stomach wall. Therefore, it is preferred that at least a wall portion of the second segment of the volume filling device is flexible or stretchable. The fluid provided by the volume filling device can be isotonic or hypertonic.

The segments of the volume filling device can be adapted to be inserted into a pouch, which is formed by part of a patient's stomach wall. The segments of the volume filling device can be adapted for filling, directly or indirectly, into the pouch formed by a part of the patient's stomach wall through a tubular instrument. In one embodiment, the volume filling device comprises a liquid with solidifying property.

This liquid or fluid can be provided to the bag via a conduit. In one embodiment, the plurality of volume filling device segments is adapted to be interconnected to form the volume filling device after said plurality of volume filling device segments have been inserted into a human bag or artificial.

The apparatus is characterized by the fact that the segments of the volume filling device are adapted to be assembled, forming an implantable volume filling device.

The segments of the volume filling device are preferably adapted to form an implantable volume filling device, of a controlled size. In general terms, any applicable feature or modality or part of modality or method described herein are, when applicable, valid for the volume filling device, as well as for the segments of the volume filling device.

-)

The invention comprises an operational method, to be combined in any way, using any apparatus, part of apparatus or system, or part of system or any claimed modality, described elsewhere in this document.

The invention comprises a method or part of method, to be used in any combination and using any apparatus or part of apparatus, or any characteristic in any combination, where the following method steps are applicable, wherein said method may comprise a or more of the following operational steps: - insert an instrument into the throat; - descend the instrument through the esophagus; - place an anvil or a unit to release fixation elements in the esophagus, between the cardia and the level of the diaphragm, to connect with the fixation of the esophagus to the stomach tissue; - lower the instrument further into the esophagus and, later, further into the stomach; - fill the stomach with gas to expand it; - suck fluid from the stomach; - observe in a guide view when said instrument comprises a camera; - connect the instrument with the stomach; - create and suture at least one pouch from the stomach wall; - filling said at least one pocket with fluid and / or a volume filling device, or two or more volume filling devices; - releasing a plurality of volume filling devices within said pouch created in the stomach tissue, through a tubular element; - pass through the stomach wall with said instrument; - passing through the stomach wall with said instrument, for placing a volume filling device outside the stomach wall; - pass through the stomach wall with said instrument, for placement of a tube that allows the placement of a subcutaneous injection port; - place a subcutaneous injection port; - suture or staple the stomach wall, from the inside to the esophagus;

- suture or staple the stomach wall connection to the stomach wall, from the inside of the stomach;

- connect the instrument with the esophagus;

- suture or staple a layer of stomach tissue to a layer of esophageal tissue; - suture or staple 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;

- suture or staple four layers of stomach tissue to a layer of esophageal tissue;

- suture or staple one or more layers of the stomach tissue to two or more positions in the esophageal tissue, the esophagus having a central esophageal axis, the esophagus also having a substantially cylindrical internal and external surface that extends radially in relation to the axis of the esophagus, and where the stomach tissue is attached to the esophageal tissue at a first point along a first axis of extension of the esophageal surface, substantially parallel to said central axis of the esophagus, and at a second point along a second esophageal surface extension axis, substantially parallel to said central esophageal axis, at a distance from said first esophageal surface extension axis, radiating from said central esophageal axis;

- release the fastening elements by means of a unit placed on said instrument;

- penetrate at least one layer of the stomach tissue and one layer of the esophageal tissue with said fixing elements;

- placing said fixation elements above the gastroesophageal junction, to create an elongated passage between the esophagus and the stomach, above said junction;

- place a part of the esophagus in the esophagus and a part of the stomach in the stomach;

- placing the fixation element substantially between the stomach and the esophageal part;

- insert said instrument into the main cavity of the stomach through the cardia,

adapted to direct the instrument in the cranial direction, to reach a position of said unit above said junction;

- allow a substantially unrestricted contraction to the elongated passage and release it from the sphincter muscle that closes the cardia placed in said junction, when such an elongated passage has been created.

The invention comprises a method or part of method, to be used in any combination and using any apparatus or part of apparatus, or any characteristic in any combination, where the following method steps are applicable, wherein said method comprises one or more more of the following operational steps: - cutting a patient's skin; - create an opening in the patient's abdominal wall; - introducing said instrument into the abdominal cavity, through said opening in the abdominal wall; - connect the instrument with the stomach; - press the instrument down into the stomach wall, in order to create,

at least one pre-shaped stomach wall pouch; - staple the stomach wall in order to create at least one pre-shaped stomach wall pouch;

- suture or staple at least one pouch to the stomach wall; - filling said at least one pocket with fluid and / or a volume filling device, or two or more volume filling devices; - releasing a plurality of volume filling devices within said pouch created in the stomach tissue, through a tubular element;

- pass through the stomach wall, inside the stomach, with said instrument; - passing through the stomach wall with said instrument, for placing a volume filling device inside the stomach wall; - pass through the stomach wall with said instrument, to suture the stomach wall to the esophageal wall; - place a volume filling device outside the stomach wall; - sheathing said volume filling device against the stomach wall;

- place a subcutaneous injection port; - suture or staple the stomach wall with the stomach wall outside the stomach;

- suture or staple the stomach wall with the stomach wall outside the stomach, without penetrating the mucosa; 0 - suture or staple two layers of stomach wall to one or two layers of stomach wall;

W 5 - connect the instrument to the esophagus; - squeeze both sides of the esophagus, to attach a layer of esophageal wall to the stomach tissue; - tighten both sides of the esophagus and the stomach wall, to fix a layer of esophageal wall to one or two layers of stomach tissue; 10 - introducing a tube or gastroscopic instrument into the esophagus, comprising an anvil element or a fixation release element, which is involved in fixing the esophagus to the stomach; a - coordinate the position of the anvil element or of a fixation release element within the esophagus, in relation to said tightening instrument, around the esophagus; 15 - suture or staple a layer of stomach tissue to a layer of esophageal tissue; - suture or staple 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 20; - suture or staple four layers of stomach tissue to a layer of esophageal tissue; - promote stapling using stapling elements of different stapling depths, in different positions, in a row of 25 stapling elements; - staple the stomach to the esophagus with a first stapling depth and staple the stomach with a second stapling depth; - stapling a pouch with stomach-to-stomach connection sutures in a row of 30 stapling elements, also comprising stapling the esophagus with stapling elements of greater depth, included as part of said stapling line;

- suture or staple one or more layers of stomach tissue in two or more positions in the esophageal tissue, the esophagus having a central esophageal axis, the esophagus © still having a substantially cylindrical internal and external surface that extends radially in relation to the central axis of the esophagus, and where the stomach tissue is fixed to the esophageal tissue at a first point along a first axis of extension of the esophageal surface, substantially parallel to said central axis of the esophagus, and at a second point along a second esophageal surface extension axis, substantially parallel to said central esophageal axis, at a distance from said first esophageal surface extension axis, radiating from said central esophageal axis; - release the fastening elements by means of a unit placed on said instrument; + - penetrate at least one layer of stomach tissue and one layer of esophageal tissue with said fixation elements; «- placing said fixation elements above the gastroesophageal junction, to create an elongated passage between the esophagus and the stomach, above said junction; - allow the elongated passage to have a substantially unrestricted contraction and release it from the sphincter muscle that closes the cardia placed in said junction, when such an elongated passage has been created; - placing a part of the esophagus in the esophagus and a part of the stomach in the stomach, 20 through an introduction into the stomach cavity; - placing the fixation element substantially between the stomach and part of the esophagus; - inserting said instrument into the main cavity of the stomach, below said junction and being adapted to direct the instrument in the cranial direction, to reach a position of said unit above said junction; 25 - operate a joint comprised in said instrument, to enable said instrument to be inserted into the main cavity of the stomach, bending said joint in a certain direction, in order to reach a position of said part of the unit in the esophagus, above said junction .

The invention comprises a method or part of method, to be used in any combination and using any apparatus or part of apparatus, or any characteristic in any combination, where the following method steps are applicable, wherein said method comprises one or more more of the following operational laparoscopic steps:

- cut a patient's skin; - insert a tube through the abdominal wall;

O - fill the abdominal cavity with fluid or gas; - introduce two or more trocars into the abdominal cavity;

U 5 - insert a camera into the abdominal cavity through one of the trocars; - introducing said instrument into the abdominal cavity through one of the trocars; - connect the instrument with the stomach; - lowering the instrument into the stomach wall to create at least one precast stomach wall pouch 10; - tighten the stomach wall to create at least one pre-shaped wall and stomach pouch;

P - suture or staple at least one pouch to the stomach wall; - filling said at least one pocket with fluid and / or a volume filling device 15, or with two or more volume filling devices; - releasing a plurality of volume filling devices within said bag created in the stomach tissue, through a tubular element; - pass through the stomach wall, inside the stomach, with said instrument; - passing through the stomach wall with said instrument, for placing a volume filling device inside the stomach wall; - pass through the stomach wall with said instrument, to suture the stomach wall to the esophageal wall; - place a volume filling device outside the stomach wall; - sheathing said volume filling device on the stomach wall; 25 - place a subcutaneous injection port; - suture or staple the stomach wall with the stomach wall outside the stomach; - suture or staple two layers of stomach wall to one or two layers of stomach wall; 30 - suture or staple the stomach wall with the stomach wall outside the stomach, without penetrating the mucosa; - connect the instrument with the esophagus;

- squeeze both sides of the esophagus to attach a layer of esophageal wall to the stomach tissue; 0

- tighten both sides of the esophagus and the end wall of the stomach to attach a layer of esophageal wall to one or two layers of stomach tissue; 0

5 - introducing a tube or gastroscopic instrument into the esophagus, comprising an anvil element or a fixation release element, which is involved in fixing the esophagus to the stomach; - coordinate the position of the anvil element or a fixation release element within the esophagus, in relation to said tightening instrument, around the esophagus;

10 - suture or staple a layer of stomach tissue to a layer of esophageal tissue; Ur

- suture or staple 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 15;

- suture or staple four layers of stomach tissue to a layer of esophageal tissue;

- promote stapling using stapling elements of different stapling depths, in different positions, in a row of elements

20 staplers;

- staple the stomach to the esophagus with a first stapling depth and staple the stomach with a second stapling depth; - staple a pouch with stomach-to-stomach sutures in a row of

25 stapling elements, also comprising stapling the esophagus with stapling elements of greater depth, included as part of the said row of stapling elements;

- suture or staple one or more layers of stomach tissue in two or more positions in the esophageal tissue, the esophagus having a central esophageal axis, the esophagus

30 further having a substantially cylindrical internal and external surface that extends radially in relation to the central axis of the esophagus, and where the stomach tissue is attached to the esophageal tissue at a first point along a first axis of esophageal surface extension , substantially parallel to said central esophageal axis, and at a second point along a second esophageal surface extension axis, substantially parallel to said central esophageal axis, at a distance from the said first surface extension axis of esophagus, radially in relation to said central esophageal axis; © 5 - release the fastening elements by means of a unit placed on said instrument; - penetrate at least one layer of the stomach tissue and one layer of the esophageal tissue with said fixing elements; - placing said fixation elements above the gastroesophageal junction, to create an elongated passage between the esophagus and the stomach, above said junction; 10 - allow the elongated passage to make a substantially unrestricted contraction and release it from the sphincter muscle that closes the cardia placed in said junction, when such

V elongated passageway has been created - place a part of the esophagus in the esophagus and a part of the stomach in the stomach,. through an introduction into the stomach cavity; 15 - placing the fixation element substantially between the stomach and part of the esophagus; - inserting said instrument into the main cavity of the stomach, below said junction and being adapted to direct the instrument in the cranial direction, to reach a position of said unit above said junction; - operate a joint comprised in said instrument, to enable said instrument 20 to be inserted into the main cavity of the stomach, bending said joint in a certain direction, in order to reach a position of said part of the unit in the esophagus, above said junction .

It should be noted that any modality or part of modality, as well as any method or part of method, or any apparatus or part of apparatus, or any characteristic or part of characteristic, or any system or part of system, or any figure or part of figure, can be combined in any applicable mode. All examples presented here should be seen as part of the general description and, therefore, in general, possible to combine in any way.

It should be understood that a person skilled in the art is in a position to combine stages, change the order of stages, and combine the elements of different modalities of the invention without any inventive effort and without departing from the scope of the present invention, as defined in following description and appended claims.

Brief Description of the Drawings 5 The present invention will now be described in greater detail, by means of non-limiting examples and with reference to the accompanying drawings, in which: - figure 1 is an overall view of a patient, showing the contours of the patient. stomach; figure 2a is a view of a first modality of an apparatus for treating obesity, implanted in a human patient; figure 2b is a sectional view taken along the line Ilbjllb, as shown in figure 2a; figures 3a-3k, 3m, 3n and 3p show different shapes and characteristics of a volume filling device comprised in an apparatus according to the invention; figures 4a-4d show an inflatable volume filling device in the deflated state, comprised in an apparatus according to the invention and an instrument for placing the volume filling device; figures 5a-5i illustrate different stages of sheathing the inflatable device shown in figure 4a, outside a patient's stomach wall; figures 6a, 6b, 7 and 8 show alternative modalities, in which the volume filling device is adapted to be adjusted non-invasively in a post-operative stage; figures 9 and 10 show modalities in which the volume filling device is adapted to be sheathed in the region of the bottom of the patient's stomach; figure 11a shows an embodiment in which a reflux treatment apparatus is also adapted to treat obesity and comprises a plurality of movement restriction device segments; figure 11b shows an embodiment in which the plurality of segments of the movement restriction device is provided in a pouch created by a part of the stomach wall, without any external containment layer; figure 11c shows a modality similar to that shown in figure 49b, but in which the part closest to the combined reflux and obesity treatment apparatus has a different composition from the most distant part of the combined reflux and obesity treatment apparatus; - figure 12 shows a modality in which the volume filling device, also adapted for reflux treatment, is combined with

5 stretching to stretch part of the back wall of the stomach; figures 13-16 show alternative modalities, in which a combination of a volume filling device and a stretching device is used; figures 17a and 17b show an embodiment in which the volume filling device is provided inside the stomach wall;

figures 18a-18h illustrate different stages of sheathing the inflatable device shown in figure 4a, inside a patient's stomach wall; figures 19a-19j illustrate different stages of sheathing the inflatable device shown in figure 4a, inside a patient's stomach wall; figures 20a-20f illustrate different stages of sheathing the inflatable device shown in figure 4a, inside a patient's stomach wall; figures 21a and 21b show instruments for surgically applying the implantable device; figure 22 is an overall view of a patient, with an implanted device for treating obesity;

figures 23-41 show several ways to activate an obesity treatment device implanted in a human patient; - figures 42-45, 46a-46c, 47 and 48a-48c show several ways of arranging hydraulic or pneumatic actuation of an apparatus for treating obesity, implanted in a human patient;

figure 49 illustrates the sheathing of a plurality of volume filling devices; figure 50 shows an embodiment of the volume filling device in segments, before assembly; figure 51 shows an embodiment of the volume filling device when a first part and a second part are assembled; figure 52 shows the mode according to figure 51, when a third part and a fourth part are assembled;

B

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figure 53 shows the mode according to figure 52, when assembling the final part; figure 54 shows the mode according to figures 50-53, when the final assembly is provided;

5 - figure 55 shows the core part of the modality shown in figure 50, with the operating channels; - Figures 55b to 55f show views in cross sections of the core part shown in figure 55a, according to the planes I-I; II-II, III-III, IV-IV, respectively;

- figures 56 and 57 show different modalities of the segments of the control device

10 volume filling; figures 58a-58d illustrate the insertion of the segments of the volume filling device shown in figure 56 by means of an instrument;

figures 59a-59c illustrate a preferred method of sheathing a plurality of volume filling device segments within a wall

15 stomach, using an instrument; figure 60 illustrates an alternative instrument for sheathing a plurality of volume filling device segments;

figures 61a-61e illustrate different shapes of the volume filling device when using a plurality of filling device segments

20 volume to form a volume filling device; figure 62 is a sectional view of a volume filling device comprising fluid;

figure 63 is a sectional view of a volume filling device,

defining a plurality of volume filling device segments;

Figure 64 is a view of a volume filling device comprising a plurality of segments of volume filling device contained in a fluid; and

figure 65 is a sectional view of a volume filling device,

comprising a plurality of volume filling device segments

30 contained in a fluid.

Description of Modalities Preferred modalities of the invention will now be described in greater detail, with reference to the attached figures. As used herein, the term "segment" should be considered broadly, in order to define any of the parts into which something can be divided. Figure 1 shows a human patient (1), who is being treated for obesity. A volume filling device (10) is provided, in order to reduce the internal volume of the stomach (12) - the food cavity of the stomach - thereby affecting the patient's appetite. The function and operation of this volume filling device will be described and explained in more detail in the following description. Figures 2a and 2b show in detail, a first of an apparatus for treating obesity, according to the invention, in which figure 2a shows a side view of the stomach, while figure 2b is a sectional view taken along the line Ilb-llb shown in figure 2a. The apparatus comprises a volume filling device (10) implanted in a human patient. More specifically, in the embodiment of figure 2a, the volume filling device (10) is sheathed on the wall (12a) of the patient's stomach, outside the stomach wall. The body of the volume filling device (10) is elongated and shaped to support against the stomach wall (12a) (12) and also has an external surface suitable to support against that wall.

By sheathing the volume filling device (10) in a part of the stomach wall, the size of the food cavity, usually referred to as (12b) in figure 2b, will be reduced, resulting in a faster feeling of satiety after ingestion of food. The volume filling device (10) preferably comprises an elastic material, such as silicone. In this way, the volume filling device can adapt to stomach movements, the degree of food intake, etc. By providing the volume filling device of a biocompatible material, the risk of the patient's body rejecting c) implant is largely reduced.

V 35/105! The volume filling device (10) can be attached to the stomach wall (12a) in several ways. In the embodiment shown in figure 2b, the 'volume filling device (10) is sheathed in the stomach wall (12a). After sheathing, a certain number of stomach-to-stomach sutures or staples (5) are applied in order to maintain sheathing for a short period of time. This allows for the growth of human tissue, which will maintain the sheath for a long period of time.

The volume filling device (10) preferably has an essentially rounded shape, so as not to cause damage to the stomach wall. An example of this is shown in figure 3a, in which the volume filling device is substantially oval in shape. In another preferred embodiment, the volume filling device is slightly curved, as in the embodiment shown in figure 3b. However, once the wall of the. stomach is strong, several different shapes, models and 15 dimensions can be used. In one embodiment, the volume filling device has a diameter of approximately 40 mm, and an extension of about 120 mm, resulting in a volume that is about half the volume of the patient's stomach. However, it is preferred that the maximum perimeter of the volume filling device is at least 30 mm, more preferably, at least 50 mm, and even more preferably, 20 at least 80 mm.

It is not necessary for the volume filling device to be stretched. In the embodiment shown in figure 3c, the volume filling device (10) is substantially spherical or ball-shaped. In order to fill the stomach, two or more volume filling devices can be combined 25 to achieve the desired decrease in the patient's stomach food cavity. It has been mentioned that the volume filling device is fixed by means of sutures or stomach-to-stomach connecting clips. In order to further improve the fixation, the volume filling device may be provided with a waist portion, having a diameter smaller than the maximum diameter of the volume filling device. This volume filling device having a waist portion (10a) is shown in figure 3d.

The volume filling device (10) can consist of at least two interconnectable portions, so that each portion is easier to insert into the stomach and also through a hole in the stomach wall. Thus, figure 3e shows a volume filling device comprising two sub-parts and more or less spherical (10b, 10c), interconnected by a portion that preferably has a smaller diameter. The smaller diameter portion may comprise an interconnection device with a reversible function, which allows for a subsequent disconnection of the two interconnected sub-parts (10, 10). This device may comprise a bayonet-type socket, a paraffin connection or similar, referred to as (IOd) in the figure. Alternatively, the smaller diameter portion may comprise a fixed interconnection, such as, for example, resilient locking hooks, provided 10 in one of the sub-parts (10, 10) and connecting with the edge of a hole provided in the other sub-part. part of said sub-parts (10, 10). and This configuration of the volume filling device (10) is not limited to a waist portion (10a). Thus, in figure 3f, a volume filling device% showing two portions of length is shown.

In order to facilitate the positioning of the volume filling device, a fixation device in the form of a handle or the like can be provided on the external surface of the volume filling device. An example of this is shown in figure 3g, where a detailed view of a handle (10e) is also shown. In a preferred embodiment, the fixing device is provided in a 20-end portion of the volume filling device (10). In order to avoid the projection of the portion on the surface of the volume filling device (10), the handle (IOe) is provided flush with the external surface of the volume filling device (10), and a recess (10f) is provided. arranged to allow the manipulation of a tightening tool or instrument (not shown in figure 3g), in order to obtain a firm tightening around the handle (10e).

The volume filling device may comprise a tube for filling or emptying said volume filling device for a fluid or a gel. When injecting fluid or gel into the volume filling device (10), the volume filling device is inflated to reach an inflated state, 30 as will be described below. The volume size of the volume filling device can also be adjusted, by moving the fluid or gel thereof, to a different reservoir.

n 37/105

P A volume filling device (10) adapted for this purpose is shown in figure 3h. A tube (10g) is firmly attached to the filling and volume device. This tube can be attached to a suitable instrument (not shown) or to an injection port, which will be explained in more detail below.

5 Instead of having a tube firmly attached, the volume filling device (10) can comprise an inlet port (10h), adapted for connecting a separate tube (not shown in this figure). It is important that the implanted volume filling device is held firmly in place, on the stomach wall where it is sheathed.

10 For this purpose, the volume filling device may be provided with one or more hollow tubes, adapted to receive sutures or staples used for fixing the sheath. Such an embodiment is shown in figure 3j, where the volume filling device (10) is provided with a row of tubes (101), provided in one. flange-type projection, which projects over the volume filling device. In this embodiment, the row of tubes extends along the longitudinal axis of the volume filling device.

Figure 3k illustrates how the sutures (14) are provided, whereby they are arranged through the stomach wall (12a) and through the holes (10i). In this way, the volume filling device is fixed in place, in the pouch created from 20 of the stomach wall and, thus, will be prevented from sliding.

While a plurality of holes are illustrated in Figure 3j, it should be noted that a single hole is sufficient to obtain an improved fixation of the volume filling device (10).

Figure 3m illustrates a volume filling device provided with an inlet port (10h). The volume filling device is sheathed in the stomach wall and the inlet port (10h) is available for connection to a tube or similar element, coming from the patient's abdominal area.

Figure 3n illustrates a sheathed volume filling device, in which instead of a port of entry, a fixed tube (10g) extends into the abdominal area 30 of the patient.

Figure 3p is a figure similar to figure 3m, but also illustrating an elongated passage of a connecting tube (10g) in the stomach wall, between the inlet port (10h) and the volume filling device (10) .

It has been shown that the shape of the volume filling device can take many different forms.

It should be noted that the material of the volume filling device may also vary.

It is preferred that the volume filling device is provided with a coating, such as a coating of Parylene®, polytetrafluoroethylene (PTFE), polyurethane or a combination of such coatings, i.e., a multilayer coating.

This multilayer coating or coating improves the properties of the volume filling device, such as its wear resistance.

In one embodiment, the volume filling device comprises an inflatable device, which is expandable to an expanded state.

In this case, the inflatable device is provided with an entrance port for a fluid and adapted to be connected to a gastroscopic instrument.

This modality will now be described in greater detail with reference to figures 4a-4d.

An inflatable volume filling device, in its non-

expanded is shown in figure 4a.

In the present case, the deflated device (10) is essentially shaped like a balloon, having an entrance port (10h). In this state, the inflatable device has a maximum diameter of a few millimeters, allowing it to be inserted into the stomach through the patient's esophagus, using a tube-type gastroscopic instrument (600),

as shown in figure 4b.

The instrument comprises an outer sleeve (60Oa) and an inner sleeve (60Ob), which can be displaced longitudinally in relation to the outer sleeve.

The inner sleeve is provided with a cutting element in the form of a cutting edge (615), at the farthest end of it.

This cutting edge can be used to cut a hole in the stomach wall, as will be explained in more detail below.

When the instrument reaches the stomach wall, see figure 4c, the inner glove is brought up to its position in the outer glove, and in contact with the stomach wall (12a). The cutting edge (615) of the inner sleeve then cuts a hole in the stomach wall, in order to allow a subsequent insertion of the volume filling device (10) into that hole (see figure 4d). In order to drive the volume filling device through the tube, a piston (602) can be provided on the instrument. Thus, the instrument further comprises a piston (602), adapted to propel a deflated volume filling device (10) out of a position in the inner sleeve, that position being shown in figure 4b, to a position outside the inner sleeve, this being shown in figure 4d.

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

An intraluminal method of sheathing a volume filling device (10) outside the stomach wall (12a) will now be described with reference to figures 5a-5i.

Initially, an instrument (600), preferably a gastroscopic instrument, is inserted into a patient's mouth (see figure 5a). The instrument comprises an injection device (601, 602), for injecting any fluid or device into the patient's stomach.

The instrument (600) further comprises a control unit (606), adapted to control the operation of the instrument.

For this purpose, the control unit (606) comprises one or more steering devices, in the modality shown, in the form of two joysticks (603), and two control buttons (604). A monitor (605) is provided to display the image provided by an optical device for viewing inside the stomach, such as a camera (not shown), arranged on the outer end of the elongated element (607), see figures 5e-5i .

The camera, which can comprise electrical connection wires extending along the elongated element, can be aided by a light source (not shown) placed farther from the elongated element, to illuminate the interior of the stomach.

The optical device may also comprise optical fibers, placed along the elongated element, which leaves the patient's body for external viewing from inside the stomach.

The instrument is also inserted into the esophagus and into the patient's stomach (see figure 5b). Through the instrument (600), a hole (12b) is created in the stomach wall (12). For this purpose, the instrument is provided with one or more cutter elements (615) at the furthest end of it, for example, in the manner described above with reference to figures 4a-4d.

These cutter elements,

logically, they can be designed in different ways, such as, for example, a toothed drum-type cutter element, rotating around the central axis of the tube-like instrument.

After cutting a hole in the stomach wall, the farthest end of the instrument (600) is inserted into the hro (12b), in order to terminate outside the stomach wall (12a). This is shown in figure 5c, showing a side view of the stomach (12), and in figure 5d, where a sectional view of the stomach 5 shown in figure 5c, taken along the lines Vd - Vd, is shown. The instrument (600 ) is adapted to create a "pocket" or "pouch", outside the stomach (12), around the hiro (12b) on the stomach wall. Said instrument and the grant provision method will now be described. Figures 5e-5i show a gastroscopic or laparoscopic instrument for sheathing a volume filling device (10) on the patient's stomach wall (12a), creating a pouch of stomach wall material (12a), in which the volume filling device is placed. The instrument, generally referred to as (600) and which can comprise the features described above with reference to figures 4a-4d, comprises an elongated element (607), having a nearer end and a more distant end, the elongated element (607) having a diameter smaller than the patient's esophagus and being flexible, in order to allow the introduction of the flexible elongated element (607) with its first end more distant through the patient's throat, esophagus and into the stomach (12), reaching at the end the stomach wall (12a).

The stomach penetrating device or cutting element (615) is provided in the elongated element (607) at the farthest end of it, to penetrate the stomach wall (12a), in order to create a hole in the stomach wall (12a) , to allow the elongated element (607) to penetrate through the shaft. The stomach penetration device (615) can be adapted to be operable, to retract said stomach penetration device (615), after the bottom wall of the stomach (12a) has been penetrated, so as not to cause further damage to the tissue inside the body. The instrument further comprises a special support device (609), provided in the elongated element (607), on the side closest to the penetration device (615).

The elongated element further comprises an expandable element (611), which is adapted to be expanded after the elongated element has penetrated the stomach wall (12a), thereby helping to create a cavity or pocket, adapted to support the device. volume filling (610). The expandable element

(611) may comprise an inflatable circular balloon, provided circumferentially, around the farthest end portion of the flexible elongate member (607). The steps of the method when sheathing the volume filling device will now be described in greater detail. After the instrument (600) has been inserted into the stomach (12), the stomach penetrating device (615) is placed in contact with the stomach wall (12a), see figure 5e. The stomach penetrating device or cutting element (615) is then arranged to create the fixture (12b) in the stomach wall, after which, at least, the expandable element (611) is disposed through the fiit (12b) in the wall of the stomach. The special support device (609), in this stage, is arranged in a support state, where it expands radially, so as to form a substantially circular support surface with the stomach wall (12a), see figure 5f. Thus, the insertion of the stomach penetrating device (615) and the expandable element (611) through the hole (12b) in the stomach wall is limited to the position shown in figure 5f.

The expandable element (611) is then expanded. In the event that the expandable element comprises a balloon or similar element, air or other fluid is injected into it.

The portion of the elongated element (607) that comprises the expandable element (611) is then retracted in the closest direction, as indicated by the arrow in figure 5g, thereby pulling the stomach wall (612) into a basket-like structure or bowl, created by the special support device (609). A suture or stapling device (608) is further provided, in the form of a device connected to the elongated member (607) or in the form of a separate instrument. The suture or stapling element comprises a suture or stapling end (613), which is adapted to close the cavity or pouch by means of stomach-to-stomach sutures or staples (14).

In an additional step, illustrated in figure 5h, an inflatable volume filling device (10) is disposed in its deflated state in the cup-like structure. The volume filling device (10) is then inflated, providing an inflated or expanded state, as seen in figure 5i. Such inflation of the volume filling device (10) can be achieved by injecting a fluid or a gel into the deflated volume filling device. In addition, it can also be obtained by injecting a material that is allowed to cure, thus

forming a solid device (10). Thus, the volume filling device (10), as shown in figures 5h and 5i, can illustrate a balloon type device, which is then filled with fluid or gel or, alternatively, with a material that is simply injected into the type structure bowl, formed by the stomach wall (12a). The fluid that is used to fill the volume filling device (10) can be any fluid suitable for filling the inflatable device (10), such as a saline solution. In another embodiment, when that fluid is a fluid that is adapted to be transformed into a solid state, the fluid may be liquid polyurethane. In order to minimize or entirely eliminate leaks, the fluid is isotonic, that is, it has the same osmolarity as the fluids in the human body. Another method of preventing diffusion is to provide a fluid that comprises large molecules, such as, for example, iodine molecules.

Stomach-to-stomach sutures or staples are preferably provided with fixation portions that exhibit a structure, such as a mesh-like structure, adapted to be in contact with the stomach wall, in order to promote the growth of human tissue, to hold for a long time the placement of the volume filling device attached to the stomach wall.

After the inflatable device (10) has been partially or fully inflated, the inlet port (IOh) (not shown in figures 5h and 5i) of the volume filling device (10) is sealed and the instrument (600) is retracted the füro (12b), which is then closed in some suitable way, such as, for example, by means of an instrument (600). The instrument is then removed from the stomach (12) and the inflatable device (10) in its inflated or expanded state is sheathed by a portion of the patient's stomach wall, outside the stomach wall. This reduces the internal volume of the stomach, thereby affecting the patient's appetite. During one or more of the steps described above, the stomach can be inflated with gas, preferably by means of a gastroscopic instrument.

The volume filling device (10) described above with reference to figures 5a-5i, has been described as an inflatable volume filling device. It should be noted that such a device may also be in the form of an elastic volume filling device, with an elasticity that allows compression, so that it is inserted into a gastroscopic instrument, and that it expands to an expanded state after leaving the instrument. An alternative embodiment of an apparatus for treating obesity will now be described with reference to figures 6a and 6b, showing a cross-sectional view of a stomach, in which a volume filling device is sheathed on the stomach wall, outside it , together with a system for adjusting the size of the volume filling device. The volume filling device is an inflatable device, as described with reference to figures 5a-5h, and thus comprises an inflation fluid.

Thus, the inflatable device (10) forms a fluid chamber, in which Mido is allowed to circulate. The inflatable device thus forms an expandable chamber, which can change the volume it occupies on the stomach wall, thereby forming an inflatable device regulated in a hydraulic or pneumatic manner. In figure 6a, an injection port (16) for fluids is connected to the inflatable volume filling device (10) by means of a conduit (18) in the form of a tube. Thus, the inflatable device (10) is adapted to be regulated, preferably, in a non-invasive manner, by moving liquid or air from the injection port (16) to the chamber formed by the inflatable device. Using a hypodermic needle or similar, the amount of fluid in the inflatable device (10) can be adjusted, thereby adjusting the size of the adjustable device. The injection port (16) can also be used to simply refill the volume filling device (10). The regulating reservoir (17) can be regulated in several ways. In an alternative embodiment, the regulating reservoir (17) is regulated by manually pressing a regulating reservoir. In other words, the regulating reservoir is regulated by moving a wall of the reservoir. It is therefore preferred that the regulation reservoir is placed subcutaneously, whereby regulation is obtained in a non-invasive manner. A sirnilar modality is shown in figure 6b. However, in this modality, the injection port (16) was replaced by an adjustable regulating reservoir (17), in fluid connection with the volume filling device (10) through a tube (18). When the regulating reservoir (17) is pressed, its volume decreases, and hydraulic fluid is moved from the reservoir to the chamber formed by the inflatable device (10), through the duct or tube (18), expanding or expanding the inflatable device (10). In this way, the

Volume filling is non-invasively adjustable in a post-operative stage. 5 It should be noted that instead of hydraulic operation, a pneumatic operation can be used, in which air, instead of hydraulic fluid, is moved between the regulation reservoir and the chamber formed by the inflatable device (10). Preferably, the regulating reservoir has a locking position, in order to keep it in the desired position. If the patient compresses the reservoir, it is preferable that it remains compressed and is released after further pressing.

Any type of hydraulic solution can be used for the inflatable device. The hydraulic solution can be activated mechanically and activated by means of a motor or pump, as well as manually. 15 In another embodiment, as shown in figure 7, a motor (40) is adapted to move a wall of the regulating reservoir (17). The activated regulation reservoir (17) is then preferably placed on the patient's abdomen. In this modality, an external wireless remote control unit, which is part of the external energy transmission device (34), can be provided to perform a non-invasive regulation of the motor, through an energy transformation device. (30), which is adapted to supply energy to an energy-consuming operating device, in the present example, the motor (40), through an energy supply line (32). The remote control device may comprise a wireless energy transmitter, whereby regulation is non-invasive by the energy transmitter. When regulation is carried out by means of a remote control device, an internal source of energy is provided for activating the regulation device. The internal source of energy can be, for example, an implantable chargeable battery or a capacitor or device for receiving wireless energy, transmitted from outside the patient's body. Different modes of regulation of the inflatable device (10) will be described below, with reference to figures 22-41.

In an alternative embodiment, as shown in figure 8, the device for treating obesity comprises a pump (44), in which the reservoir is regulated by the pump (44), which promotes the pumping of fluid or air from the reservoir to the chamber formed by the inflatable device. Different configurations of this pump will be described below, with reference to figures 22-

41.

An alternative embodiment of an apparatus for treating obesity will now be described with reference to figure 9, which shows a stomach (12) of a patient who is treated for obesity. This embodiment is similar to that described above with reference to figure 7, and the apparatus comprises a volume filling device in the form of an inflatable device (10), which is sheathed in the wall (12a) of the patient's stomach (12). However, in this case, sheathing was performed at the bottom, that is, in the upper part of the stomach, where the number of receptors on the stomach wall is large, and the inflatable device works as a stretching device for the part of the hindoo wall. of the stomach.

A regulating reservoir (17) for fluids is connected to the inflatable device, by means of a conduit (18) in the form of a tube. The inflatable device (10) is thus adapted to be regulated, preferably, non-invasively, by moving liquid or air, from the regulating reservoir (17) to the chamber formed by the inflatable device (10). The regulation of the inflatable device (10) preferably comprises a servo-inverted mechanism, that is, a small volume is actuated, for example, by the patient's finger, this small volume being in connection with a larger volume, that is, the reservoir of regulation (17). Thus, the inflatable device (10) is placed outside the stomach wall, being adapted to stretch a part of the stomach end wall, thereby affecting the patient's appetite. By enlarging the size of the stretching device, the stomach wall (12a) surrounding the inflatable stretching device (10) is stretched, as the perimeter of the inflatable stretching device (10) is increased. Upon stretching, the receptors on the stomach wall indicate that the stomach is full, thereby creating a feeling of satiety for the patient. Correspondingly, when the stretching device (10) is contracted, the receptors indicate that the stomach is not full, thereby returning the feeling of hunger. It should be noted that this modality combines the effects of reducing the volume of the gastric cavity of the stomach and part of the stretching of the stomach wall, thereby increasing the effectiveness of the treatment.

P

46/105

The expansion and contraction of the stretching device (10) can be performed under direct control of the patient.

Alternatively, expansion and contraction can be performed according to a pre-programmed scheme.

In a preferred embodiment, as shown in figure 10, a sensor 5 (19) is provided in a suitable position, such as, in the esophagus.

The volume filling device (10), in the form of an inflatable stretching device, is similar to that shown in figure 9. By providing one or more sensors, the device for treating obesity can be automated, in which the size of the device volume filling (10) in the form of the inflatable stretching device is adjusted,

10 depending on the amount of food entering the food cavity of the stomach.

Thus, the fluid is moved between the inflatable volume filling device (10) and a fluid reservoir (15). The device for treating obesity may have the additional functionality of reflux treatment.

One embodiment having this function is shown in figure 11a, in which the volume filling device

15 (10) is sheathed in the stomach wall, near and at least partially above the patient's cardia (26), when the patient is in the standing position, being fixed in a position above the cardia area (26) by by means of a fixing element, such as sutures or staples (14a). Thus, for example, a direct or indirect fixation to the diahagma muscle or other muscle tissue can be provided.

Like

20 Alternatively, a direct or indirect fixation to the esophagus, tight and close to the angle of His, can be provided.

In this alternative modality, the volume filling device (10) rests in a position against the wall of the fündo's stomach, when implanted, and which also fills a thick volume of the cardia area (26), between the cardia and the diaphragm muscle. , so that the cardia is prevented from sliding into the

25 chest cavity, so reflux disease is prevented.

In this preferred embodiment, the apparatus for treating reflux disease and obesity comprises two or more segments of a movement restriction device, adapted to form the movement restriction device (310). In this modality, there is a plurality of segments of devices of restriction of

Spherical movement, in the form of small spheres, which are contained in a segment of movement restriction device in the form of an outer layer or shell, which is preferably elastic or flexible.

In this way, the outer layer can be inserted into the stomach as a separate part, which is then filled with a plurality of spherical or polyhedral segments of movement restriction devices.

This method will be explained below with reference to figures 59 to 59C.

By providing a movement restriction device (310) with a plurality of segments of movement restriction devices, said movement restriction device (310) will easily adapt to the movements of the stomach, within which it is sheathed .

In an alternative embodiment, the small segments of the movement restriction device are inserted or injected into a bag, previously

10 created by the patient's stomach wall, without any external collection layer or shell.

This modality is illustrated in figure 11b, and corresponds to the method described below, with reference to figures 59a-59c.

In order to provide a movement restriction device that is more stable in the nearest part (310 '), that part can be made in a different

15 configuration of the most distant part (310 "). Thus, in an embodiment shown in figure 11C, the nearest part (310 '), which is fixed in a position above the cardia area (14C), comprises a part or segment in the form of a larger sphere, while the most distant part (310 ") comprises a plurality of small segments of movement restriction devices.

This modality combines the

20 advantages of a closer stable part (310 '), used to prevent reflux, with a more distant more adaptable part (310 "), used as a volume filling device for treating obesity.

Generally, the closest and most distant parts can have different configurations and contents, independently of each other.

This content can be a mix of solid content and

25 fluid, such as increased friction or reduced fluid.

Such a volume filling device (10) can be used for the maintenance of the electronic elements and / or source of energy and / or hydraulic fluid.

The hydrogen fluid from this device can be distributed to several smaller areas of the inflatable device, to vary the stretch area from time to time,

30 avoiding any possible effect of more permanent stretching of the stomach wall.

Even by mechanical action, several stretching areas can be used.

+ 48/105 In an alternative embodiment, as shown in figure 12, the volume of an inflatable volume filling device (10) can be in fluid connection, preferably with one or more smaller inflatable devices or chambers (50). These chambers are adapted to communicate with fluid or air, moved between the 5 chambers. Thus, the larger chamber (10) is adapted to the disposition of its main volume, to constitute a volume filling device to reduce the size of the food cavity and to treat reflux disease, and one or several smaller chambers are adapted to function as inflatable devices, 10 for the treatment of obesity, in which the main chamber is adapted to communicate with fluid or air with the smaller chambers, causing a stretching effect on the stomach wall, thereby also treating obesity. In figures 13-16, different embodiments are shown incorporating a combination of a volume filling device sheathed in the central or lower portion of the stomach, and a stretching device sheathed in the upper or lower portion of the patient's stomach. Thus, an adjustable volume filling device (10) is shown in figure 13, which is sheathed in a patient's stomach wall (12). In addition, an adjustable stretching device (50), with the function described above, is sheathed in the bottom wall of the patient's stomach. It is preferred that the volume filling device (10) is substantially larger than the stretching device (50). The volume filling device (10) and the stretching device (50) are in fluid communication with each other, through a fluid communication device, comprising a first fluid tube (52), in which a pump ( 54). The pump (54) is under the control of an energy transforming device (30), which is adapted to supply the pump (54) with energy, through an energy supply line (56). The energy transformation device (30) is also connected to a sensor (19), provided in the patient's esophagus, so that food intake can be detected.

The volume filling device (10) and the stretching device (50) are also in fluid communication with each other, with a second fluid tube (58), which preferably has a smaller cross-sectional area than the first tube of tube (52).

B 49/105 The operation of this provision is as follows. The volume of the volume filling device (10) works as in the described modalities above, that is, it reduces the size of the food cavity of the patient's stomach (12). In addition, when the stretching device (50) is enlarged by the pumping fluid of the volume filling device (10) and to the stretching device (50) by means of the pump (54), the stomach wall is stretched, creating a feeling of satiety for the patient. Thus, for example, when food intake is detected by means of the sensor (19), the fluid is automatically pumped into the stretching device (50), to increase the feeling of satiety and, thus, limit the intake of foods. When the dye has been injected into the stretching device (50), the internal pressure in question is higher than the internal pressure in the volume filling device (10). This pressure difference will create a flow of fluid in the second tube (58), preferably narrower, of the stretching device (50), in the direction of the volume filling device (10). The flow / flow rate will be determined, among other things, by the pressure difference and the cross-sectional area of the second tube (58). It is preferred that the second tube is so dimensioned that the pressures in the volume filling device (10) and in the stretching device (50) return to equilibrium, after three hours of the fluid having been injected into the pressure device. stretching (50), to create the feeling of satiety.

In this embodiment, the function of the second tube (58) is to allow the fluid to return from the stretching device (50) to the volume filling device (10). It should be noted that this function can also be performed by the pump (54) on the first tube (52), and in which the second tube (58) can then be omitted. Figure 14 illustrates a modality similar to that shown in figure 13. Thus, an adjustable volume filling device (10) is provided, which is sheathed in the stomach wall of a patient's stomach (12). In addition, an adjustable stretching device (50), with the function previously described, is sheathed in the fundus wall of the patient's stomach. It is preferred that the volume filling device (10) is substantially larger than the stretching device (50).

The volume filling device (10) and the stretching device (50) are in fluid communication with each other through a first fluid tube (52) and a second fluid tube, which preferably has a section area smaller than that of the first fluid tube. However, instead of a pump, a back pressure valve (60) is provided in the first fluid tube (52), instead of an energized pump. This back pressure valve (60) allows the fluid to circulate in the direction of the volume filling device (10) and the stretching device (50), but not vice versa. This means that this modality can be entirely non-energized. Instead, it operates according to the following 10 principles. When the food cavity of the stomach (12) is substantially

When deflated, there is a state of balance between the internal pressure of the volume filling device (10) and the stretching device (50). In this state, the stretching device is in a non-stretched state, that is, it does not stretch «15 a part of the stomach wall and thus does not create a feeling of satiety. When the patient begins to eat, the food will enter the food cavity of the stomach (12). This will create an increase in pressure in the stomach wall, in which the volume filling device (10) is sheathed, and the internal pressure in question will be increased. Also, the muscles of the stomach wall will begin to process food in the food cavity through contraction, which also contributes to an increase in internal pressure in the volume filling device (10). Since the internal pressure in the stretching device (50) will remain essentially unmodified, due to the fact that it is located in the upper part of the stomach (12), where no food exerts pressure on the stomach wall, a flow of fluid will be created through the first and second fluid tubes (52), (58), in the direction of the volume filling device (10) and the stretching device (50). This, in turn, will increase the volume of the stretching device (50), which, by stretching the stomach wall of the stomach, will provide a feeling of satiety for the patient. A flow of fluid from the stretching device (50) to the volume filling device (10), through the second tube (58), will return to

The 51/105 pressure of these devices for balance, as described above with reference to figure 13. "Figure 15 illustrates a modality that is similar to that shown in figure 14, but, with the addition of an injection port (16), which is used to refill the fluid system, comprising the volume filling device (10) and the stretching device (50) or, alternatively, to actively adjust the size of said system. illustrates a modality in which the stretching device (50) can be actively adjusted, by manually pressing an adjustment reservoir, which is provided subcutaneously under the patient's skin, similar to the modality shown in figure 9. Thus, a reservoir of regulation for "fluids (17) is connected to the inflatable device, by means of a conduit (18) in the form of a tube. In this way, the stretching device (50) is adapted to be adjusted,

W non-invasively, by moving liquid or air from the

The regulation (17) for the chamber formed by the inflatable device. The adjustment of the stretching device (50) preferably comprises a servo-inverted mechanism, that is, a small volume is actuated, for example, by the patient's finger and that small volume is in connection with a larger volume. An alternative placement of the volume filling device (10) 20 is shown in figures 17a and 17b, in which figure 17b shows a sectional view of the stomach shown in figure 17a, along the line XVIlb - XVIlb. Thus, the volume filling device (10) is adapted to be placed inside the stomach wall (12), such as, through a gastroscopic or siniilar instrument the intraluminal instrument, and supporting itself inside the stomach wall ( 12a). The inflatable device can be kept sheathed by means of sutures or staples (14), as in the modalities of figures 2a and 2b. In this mode, no holes are required in the stomach wall. Instead, a method for providing the volume filling device (10) may comprise the following steps, which will be explained with reference to figures 18a-18i, showing a sheath instrument.

The sheath instrument, generally referred to as (630), comprises an elongated tube element (632), similar to the elongated element (607), which has been described above with reference to figures 5a-5i. Thus, the instrument can be connected to a control unit (606), see figure 5a. The sheath instrument (630) further comprises a suction portion (634), which is preferably elongated.

The suction portion (634) exhibits a plurality of small holes (636), within which air will be sucked by providing suction in the tube element (632). This suction effect will be used to create a "pocket" or a

"pouch" in a part of a stomach wall, usually referred to by (12a). In other words, when the tip of the suction portion (634) is pressed against the stomach wall (12a), see figure 18a, a larger recess will be formed.

The part of the stomach wall (12a) that forms the recess, due to the suction effect, will adhere to the suction portion (634) of the sheath instrument (630). As the suction portion (634) is pressed further into the stomach wall (12a), as seen in figure 18c, a deeper recess will be formed, until the entire suction portion (634) is embedded in the recess, as can be seen in figure 18d.

The edge of the recess at this stage will be fixed by means of fixing elements (638) and the suction portion will be removed from the instrument, as can be seen in figure 18e.

An elastic and compressed volume filling device (10) will subsequently be inserted into the recess, as seen in figure 18f, for example, in the manner described above with reference to figure 4d.

This compressed volume filling device is then expanded to its final shape, as seen in figure 18g, after which the bag is sealed by suturing or stapling by means of the said fixing elements, as can be seen in figure 18h.

All of the alternatives described above with reference to figures 2-16 are also applicable to the embodiment described with reference to figures 17 and 18, that is, to the embodiment in which the volume filling device is sheathed within the stomach wall.

Figures 19a-19j show an instrument for use in a method of connecting a volume filling device (10) to a patient's stomach wall (12).

The instrument is adapted to be inserted through an object modeled as a narrow tube, such as a gastroscope, used in an intraluminal procedure, or a laparoscopic trocar, used in a laparoscopic procedure.

The instrument comprises an elongated element (650), which is adapted to be flexible by means of a construction comprising multiple ring-shaped elements, however, it is also conceivable that said elongated element (650) is adapted to be flexible, wherein said elongated member (650) is made of a flexible or adjustable material.

The elongated element (650) is inserted into the body and placed in the vicinity of the patient's stomach wall (12), from outside or inside said body.

The elongated element (650) has a special support device

5 (651), adapted to support the stomach by means of mechanical apprehension or vacuum elements.

The special support device (651) comprises a first joint (652) and a second joint (653), which makes it possible for the special support device (651) to be operable in relation to the elongated element (650), thereby placing the part of the support device (651), which comprises the elements

10 apprehension mechanics or vacuum means, in contact with the patient's stomach wall (12).

Figure 19b shows the special support device (651) when placed in contact with the stomach wall (12) of a human patient, after which, the special support device (651) connects with the stomach wall (12 ), in order to support the stomach wall (12). Figure 19C shows the instrument

15 when the advance step of the driving rod (654) is carried out, starting from the elongated element (650). The thrust rod (654) pushes the stomach wall (12) to create a cavity or pocket therefrom.

Figure 19d shows the instrument rotated 90 ° with respect to figures 19a-19c.

This view shows the special support elements (651a, 651b) operationally attached to the two

20 sides of the elongated element (650), and in contact with the stomach wall (12), supporting said stomach wall (12), when the push rod (654) promotes the push, to create a cavity or pocket.

When the thrust rod (654) has propelled the stomach wall (12) to a desired position, the special support devices (651a, 651b) move

25 direction of the thrust rod (654) and thereby close said cavity or said pocket.

After the cavity or pouch has been created, they need to be sealed.

Figure 19f shows the advancement of a suture or stapling device (655), from the elongated element (650). The suture or stapling device (655) is

30 positioned in connection with the stomach wall, after which the suture or stapling device initiates the suture or stapling procedure of the stomach wall (12), creating a seal for the stomach-to-stomach sutures or staples (14 ). The instrument is moved along the stomach wall (12) of the

V patient and, thus, a cavity or bag is created and sealed using the instrument, as shown in figures 19g and 19h. When a cavity or pocket or a desired space has been created and sealed, an insertion element (656) is advanced from the elongated element (650). The insertion element (656) is adapted to insert an innable volume filling device (10), as previously described herein. After the insertion element (656) has been positioned in the cavity or bag, the volume filling device (10) is inserted through the insertion element (656) into the cavity or bag, using a pressurized fluid or gas, or by means of a mechanical advance element, pushing said inflatable volume filling device (10) into the cavity or bag. The insert then inflates the inflatable volume filling device with a fluid

W or gas, and seal the final section of the pouch using sutures or staples connecting stomach to stomach (14). The described mode explains the process of inserting a device

U

Inflatable volume filling N, however, it is equally conceivable that the volume filling device 15 (10) can be expanded by means of the volume filling device (10) made of an elastic material. Figures 20a-20f show an instrument for use in a method of connecting a volume filling device (10) to a patient's stomach wall (12). The instrument is adapted to be inserted through an object 20 modeled as a narrow tube, such as a gastroscope, used in an intraluminal procedure, or a laparoscopic trocar, used in a laparoscopic procedure. The instrument comprises an elongated element (660), which is adapted to be flexible by means of a construction comprising multiple ring-shaped elements, however, it is also conceivable that said elongated element 25 (660) is adapted to be flexible , wherein said elongated member (660) is made of a flexible or adjustable material. The elongated element (660) is inserted into the body and placed in the vicinity of the patient's stomach wall (12), from outside or within said body. The elongated element (660) has multiple special support devices (661), adapted to support the stomach by means of mechanical gripping or vacuum elements. The special support devices (661) are locked in position along the elongated element (660) by means of a locking ring (662). The special support devices are made of one end of flexible material and previously folded to expand

B

55/105 ¢ inside a funnel-style device, when said locking ring (662) is removed.

The special support device in its expandable state in the form of a "funnel is shown in figure 20b.

Figure 20b also shows the special support device (661) when placed in contact with the stomach wall (12) of a

5 human patient, after which, the special support element (661) connects to the stomach wall (12), to support the stomach wall (12). Figure 20c shows the instrument when the step of advancing a push rod (664) is carried out, starting from the elongated element (660). The push rod (664) pushes the stomach wall (12) to create a cavity or

10 bag from it.

When the thrust rod (664) has propelled the stomach wall (12) to a desired position, the special "holding devices (661) move in the direction of the thrust rod (664) and thereby close the said cavity or said pocket.%

After the cavity or pouch has been created, they need to be sealed. - 15 Figure 20d shows the advance of a suture or stapling device (665), from the elongated element (660). The suture or stapling device (665) is positioned in connection with the stomach wall, after which the suture or stapling device (665) initiates the suture or stapling procedure of the stomach wall (12), creating a seal for the stomach connecting sutures or staples to

Stomach (14). After that, a weighting element (666) is advanced from the elongated element (660), and the special support devices (661) are retracted.

The wicking element (666) is adapted to insert an inflatable volume filling device (10), as previously described here.

After the insertion element (666) has been positioned in the cavity or pouch, the filling device

25 volume (10) is inserted through the insertion element (666) into the cavity or bag, by means of a pressurized fluid or gas, or by means of a mechanical advancing element, driving said inflatable volume filling device (10) into the cavity or pouch.

The insertion element (666) then inflates the inflatable volume filling device with a fluid or gas, and seals the final section of the bag

30 using stomach-to-stomach sutures or staples (14). The described mode explains the process of inserting an inflatable volume filling device (10),

meanwhile, it is also conceivable that the volume filling device (10)

can be expanded by means of the volume filling device (10) made of an elastic material. Figure 20f shows the volume filling device (10) when sheathed on the stomach wall (12), in a cavity or pouch sealed with

The sutures or staples connecting stomach to stomach (14). Figure 21a shows an instrument used in a method of connecting a volume filling device according to any of the present embodiments with a stomach wall (12). The instrument comprises an elongated element (670), which is adapted to be flexible by means of a construction comprising multiple ring-shaped elements, however, it is also conceivable that said elongated element (670) is adapted to be flexible , wherein said elongated member (670) is made of a flexible or adjustable material. The elongated member (670) is inserted into the body and placed in the vicinity of the patient's stomach wall (12), from within said body. A stomach penetrating element (672) is placed at the far end 0 of the elongated element (670), retractably attached to a protective sleeve (673), h 15 adapted to protect the body tissue from the sharp penetrating element or cutter element (672), after the cutting operation has been carried out.

Figure 21b shows the instrument comprising the elongated element (670), after the cutting operation has been carried out, and the penetrating element or stomach cutting element (672) has retracted into the protective sleeve (673). A guide wire (671) is driven through the elongated element (670), through the hole made in the stomach wall (12), outside the abdomen, and placed inside the patient's skin, which is penetrated from the outside , to allow the guide wire (671) to exit the abdomen. The guide wire (671) can then be used to direct a conduit (18) or a wire attached to the volume filling device (10), placed in the stomach from 25 inside it. The volume filling device (10) with the conduit (18) or with the electric wire, constitutes a volume filling device (10) according to any of the present modalities. The direction of the conduit (18) or the electrical wire makes it possible to fix the conduit (18) or the electrical wire to a control unit (42), placed subcutaneously on the patient, from the outside of the abdomen.

Figure 22 illustrates a system for treating a disease, comprising an apparatus (10), which comprises a volume filling device according to the invention, placed on the abdomen of a patient. An implanted energy transformation device (1002) is adapted to supply

V 57/105 energy for energy-consuming components of the device, through a power supply line (1003). An external energy transmission device (1004) for non-invasively energizing the apparatus (10) transmits energy by means of at least one wireless energy signal. The implanted energy transformation device 5 (1002) transforms energy from the wireless energy signal into electrical energy, which is supplied through the power supply line (1003).

The implanted energy transformation device (1002) may also comprise other components, such as: a coil for receiving and / or transmitting signals and energy, an antenna for receiving and / or transmitting signals, a microcontroller, a control unit charge control optionally comprising an energy storage device, such as a capacitor, one or more sensors, such as, for example, temperature sensor, pressure sensor, positioning sensor, motion sensor, etc., a transceiver, a motor, optionally including a motor controller, a pump and other parts to control the operation of a medical implant. The wireless power signal can include a wave signal selected from the following: a sound wave signal, an ultrasonic wave signal, an electromagnetic wave signal, an infrared light signal, a visible light signal, a ultraviolet light signal, a laser light signal, a microwave signal, a radio wave signal, an X-ray radiation signal, and a gamma radiation signal. Alternatively, the wireless energy signal can include an electric or magnetic field or a combination of electric and magnetic fields.

The wireless power transmission device (1004) can transmit a carrier signal to carry the wireless power signal. That carrier signal may include a digital signal, an analog signal or a combination of digital and analog signals. In that case, the wireless power signal includes an analog signal or a digital signal, or a combination of analog signal and digital signal.

In general, the energy transformation device (1002) is provided to transform the wireless energy from a first form of energy, 30 transmitted by the energy transmission device (1004), into a second form of energy, which, it is typically different from the first form of energy. The implanted device (10) is operable in response to the second form of energy. The energy transformation device (1002) can directly drive the device with the second

Q

58/105 energy form, when the energy transformation device (1002) transforms the first energy form, transmitted by the energy transmission device (1004), into the second energy form.

The system can also include an implantable accumulator, where the second form of energy is used, at least partially, to

5 charge the battery.

Alternatively, the wireless energy transmitted by the power transmission device (1004) can be used to directly power the device, when wireless energy is being transmitted by the power transmission device (1004). When the system comprises an operating device to operate

10 the apparatus, as will be described below, the wireless energy transmitted by the energy transmitting device (1004) may be used to directly drive the operating device, to create kinetic energy, in order to promote the operation of the apparatus.

The wireless energy of the first energy form may comprise sound waves and the energy transforming device (1002) may include an element

15 piezoelectric, to transform sound waves into electrical energy.

The energy of the second form of energy may comprise electrical energy, in the form of a direct current or pulsating direct current, or a combination of direct current and pulsating direct current, or an alternating current, or a combination of direct current and alternating current.

Typically, the device comprises electrical components that are energized with electrical energy.

Other implantable electrical components of the system may include at least one voltage level protector or at least one constant current protector, connected to the electrical components of the device.

Optionally, one of the energy of the first form of energy and energy of the second form of energy may comprise magnetic energy, kinetic energy, sound energy, chemical energy, radiant energy, electromagnetic energy, photoelectric energy, nuclear energy, or thermal energy.

Preferably, one of the energy of the first energy form and energy of the second energy form may comprise non-magnetic energy, non-kinetic energy, non-chemical energy, non-sonic energy, non-nuclear energy or non-thermal energy.

The energy transmission device can be controlled from outside the patient's body to release wireless electromagnetic energy, and the wireless electromagnetic energy released is used to operate the device.

Alternatively, the

W 59/105 The energy transmission device is controlled from outside the patient's body to release wireless non-magnetic energy, and the released wireless non-magnetic energy is used to operate the device. The external power transmission device (1004) also includes a wireless remote control device, having an external signal transmitter to transmit a wireless control signal, to non-invasively control the apparatus. The control signal is received by an implanted signal receiver, which can be incorporated into the implanted energy transformation device (1002), or be separated from it.

10 The wireless control signal may include a frequency, amplitude, or modulated phase signal, or a combination thereof. Alternatively, the wireless control signal includes an analog signal or a digital signal, or a combination of an analog signal and a digital signal. Alternatively, the wireless control signal comprises an electric or magnetic field, or a combination of magnetic field and electric field. The wireless remote control device can transmit a carrier signal to carry the wireless control signal. This carrier signal can include a digital, analog signal or a combination of digital and analog signals. When the control signal includes an analog signal or a digital signal, or a combination of an analog and digital signal, the wireless remote control device preferably transmits an electromagnetic carrier wave signal to carry the digital control signals or analog.

Figure 23 illustrates the system shown in Figure 22, in the form of a more generalized block diagram, showing the apparatus (10), the energy transformation device (1002) driving the apparatus (10) through the supply line ( 1003), and the external power transmission device (1004). The patient's skin (1005), usually shown by means of a vertical line, separates the patient's interior, to the right of the line, from the patient's exterior, to the left of the line.

Fig. 24 shows a modality of the invention, identical to modality 30 shown in Fig. 23, except that an inversion device, in the form of an electrical switch (1006), operable, for example, by means of polarized energy, is also implanted in the patient to invert the device (10). When the switch is operated by polarized energy, the wireless remote control of the external

U

60/105 power transmission (1004) transmits a wireless signal that conducts polarized energy, and the implanted energy transformation device (1002) transforms the polarized wireless energy into a polarized current to operate the electrical switch (1006). When the polarity of the current is changed by the energy transforming device

5 implanted (1002), the electrical switch (1006) inverts the function performed by the device (10). Figure 25 shows an embodiment of the invention identical to that shown in figure 23, except that an operating device (1007) implanted in the patient to operate the device (10) is provided between the implanted energy transformation device (1002) and the apparatus (10). This operating device can take the form of a motor (1007), for example, an electric servo motor.

The motor (1007) is activated with the power of the implanted power transforming device (1002), when the remote control of the external power transmitting device (1004) transmits a wireless power signal to the receiver of the power transforming device. implanted energy (1002). Figure 26 shows an embodiment of the invention identical to that shown in figure 23, except that an operating device, in the form of an installation (1008), including a motor / pump unit (1009) and a fluid reservoir (1010 ), is also implanted in the patient.

In that case, the apparatus (10) is hydraulically operated, that is, hydraulic fluid is pumped by the motor / pump unit (1009), from the fluid reservoir (1010), through a conduit (1011) to the apparatus ( 10), to operate said apparatus, and hydraulic fluid is pumped by the motor / pump unit (1009), back from the apparatus (10) to the fluid reservoir (1010), to return the apparatus to a starting position.

The implanted power transformation device (1002) transforms the wireless energy into a current, for example, a polarized current, to drive the motor / pump unit (1009) through an electrical power supply line (1012). Instead of having a hydraulically operated apparatus (10), it is also conceivable that the operating device comprises a pneumatic operating device.

In this case, the hydraulic fluid can be pressurized air, to be used in a regulation procedure, and the fluid reservoir is replaced by an air chamber.

Q In all of these modalities, the energy transformation device (1002) can include a rechargeable accumulator, such as a battery or capacitor, 0 to be charged by wireless energy, to supply energy to any energy consuming part of the system. system.

5 Alternatively, the wireless remote control device described above can be replaced by a manual control of any implanted part, when making contact with the patient's hand, most likely, indirect contact, for example, pressing a button placed under the skin.

Figure 27 shows an embodiment of the invention comprising the external energy transmission device (1004), with its wireless remote control device, the apparatus (10), in this case, hydraulically operated, and the energy transformation device. implanted (1002), also comprising a reservoir of

K hydraulic fluid (1013), a motor / pump unit (1009) and an inverting device * in the form of a hydraulic valve bypass device (1014), all b 15 implanted in the patient. Logically, the hydraulic operation can be easily performed, just by changing the direction of the pumping, so the hydraulic valve can then be omitted. The remote control can be a device separate from or included in the external power transmission device. The motor of the motor / pump unit (1009) is an electric motor. In response to a control signal 20 from the wireless remote control of the external power transmission device (1004), the implanted power transformation device (1002) activates the motor / pump unit (1009) with power from the power carried by the control signal, whereby the motor / pump unit (1009) distributes hydraulic fluid between the hydraulic fluid reservoir (1013) and the apparatus (10). The remote control of the external power transmission device (1004) controls the hydraulic valve bypass device (1014), to deflect the flow direction of the hydraulic fluid, between a direction in which the fluid is pumped by the motor unit / pump (1009) from the hydraulic fluid reservoir (1013) to the device (10), in order to operate the device, and in the opposite direction, in which the fluid is pumped by the motor / pump unit (1009) back from the device (10) to the hydraulic fluid reservoir (1013), in order to return the device to a starting position.

Figure 28 shows an embodiment of the invention, comprising the external power transmission device (1004) with its wireless remote control,

the apparatus (10), the implanted energy transformation device (1002), an implanted internal control unit (1015), controlled by the wireless remote control of the external energy transmission device (1004), an implanted accumulator (1016) and an implanted capacitor (1017). The internal control unit (1015) has 5 electrical energy storage received from its energy transformation device (1002) in the accumulator (1016), which supplies energy to the device (10). In response to a control signal from the wireless remote control of the external power transmission device (1004), the internal control unit (1015) releases electrical energy from the accumulator (1016) and transfers the energy released through the power supply lines. (1018) and 1019), or directly transfers electrical energy from the implanted energy transformation device (1002), through an energy supply line (1020), capacitor (1017) (which stabilizes the electric current), power line power supply (1021) and power supply line (1019), for operating the device (10). The internal control unit is preferably programmable from outside the patient's body.

In a preferred mode, the internal control unit is programmed to regulate the device (10), according to a previously defined time schedule or according to the information input of any sensor that detects any possible physical parameter of the patient, or any functional parameter of the system.

According to an alternative, the capacitor (1017) in the modality shown in figure 28, can be omitted.

According to another alternative, the accumulator (1016) in this mode can be omitted.

Fig. 29 shows a modality of the invention identical to the modality shown in Fig. 23, except that a battery (1022), for power supply for the operation of the device (10), and an electrical switch (1023), for switching the operation device (10), are also implanted in the patient.

The electrical switch (1023) can be controlled by the remote control and can also be operated by the energy supplied by the implanted energy transformation device (1002), to switch off in a mode, in which the battery (1022) is not in use, to a connected mode, in which the battery (1022) supplies power for the operation of the device (10). Fig. 30 shows a modality of the invention identical to the modality shown in Fig. 29, except that an internal control unit (1015),

controllable by the wireless remote control of the external power transmission device (1004) is also implanted in the patient. In this case, the electrical switch "(1023) is operated by the energy supplied by the implanted energy transformation device (1002), to switch off, in which the wireless remote control is prevented from operating the internal control unit. (1015) and the battery is not in use, for a standby mode, in which the remote control is allowed to command the internal control unit (1015), to release electrical energy from the battery (1022), for the operation of the device (10).

Fig. 31 shows a modality of the invention identical to modality 10 shown in Fig. 30, except that an accumulator (1016) is replaced by a battery (1022) and the implanted components are interconnected differently. That. In this case, the accumulator (1016) stores energy from the implanted energy transformation device (1002). In response to a control signal from the wireless remote control of the external power transmission device (1004), ah 15 internal control unit (1015) controls the electrical switch (1023) to switch off, in which the accumulator (1016) is not in use, for a connected mode, in which the accumulator (1016) supplies power for the operation of the apparatus (10). The accumulator can be combined with, or replaced with, a capacitor. Fig. 32 shows a modality of the invention identical to modality 20 shown in Fig. 31, except that a battery (1022) 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 (1004), the internal control unit (1015) commands the accumulator (1016) to release energy to operate the electrical switch (1023), to switch from an off mode 25, in which the battery (1022) is not in use, to an on mode, in which the battery (1022) supplies electrical energy for the operation of the device (10). Alternatively, the electrical switch (1023) can be operated by the energy supplied by the accumulator (1016), to switch off, in which the wireless remote control is prevented from controlling the battery (1022) to supply electrical energy and the it is not in use, for a standby mode, in which the wireless remote control is allowed to control the battery (1022), to supply electrical energy for the operation of said device (10).

% 64/105 »It should be understood that the switch (1023) and all other switches in the present patent application must be interpreted in its broadest mode 4. This means a transistor, MCU, MCPU, ASIC, FPGA or a D / A signal converter (digital / analog), or any other component or electronic circuit 5 that can switch the power on and off. Preferably, the switch is controlled from outside the patient's body, or alternatively, by an implanted internal control unit.

Fig. 33 shows a modality of the invention identical to the modality shown in Fig. 29, except that a motor (1007), a mechanical inversion device 10, in the form of a gearbox (1024), and an internal control unit ( 1015) to control the gearbox (1024) are also implanted in the patient. The internal control unit (1015) controls the gearbox. (1024) to reverse the operation performed by the device (10) (mechanically

W

V operated). An even simpler procedure is to electronically change the direction of the engine. The gearbox interpreted in its broadest modality can mean an arrangement of a servo mechanism, saving strength for the operating device, in favor of a longer stroke performance.

Fig. 34 shows a modality of the invention identical to the modality shown in Fig. 40, except that the implanted components are interconnected differently. Thus, in this case, the control unit (1015) is activated by the battery (1022) when the accumulator (1016), suitably a capacitor, activates the electrical switch (1023) to switch to an on mode. When the electric switch (1023) is in its on mode, the internal control unit (1015) is allowed to command the battery (1022) to supply or not supply energy for the operation of the device (10). Figure 35 shows, in a schematic way, conceivable combinations of implanted components of the device, to obtain several communication options. Basically, the device (10), the control unit (1015), the motor or pump unit (1009) and the external power transmission device (1004), including the external wireless remote control, are shown. As already described above, the wireless remote control transmits a control signal that is received by the internal control unit (1015), which, in turn, controls the various implanted components of the device.

A feedback device, preferably comprising a sensor or a measuring device (1025), can be implanted in the patient to detect a physical parameter of the same.

The physical parameter can be at least one parameter selected from the group consisting of pressure, volume,

5 diameter, stretching, stretching, extension, movement, bending, elasticity, muscle contraction, nervous impulse, body temperature, blood pressure, blood flow, heartbeat and breathing.

The sensor can detect any of the above physical parameters.

For example, the sensor can be a pressure sensor or a motion sensor.

Alternatively, the sensor (1025) can be arranged to detect a functional parameter.

The functional parameter can be correlated to the transfer of energy for charging an implanted energy source, and can also include at least one parameter, selected from the group of parameters consisting of: electricity, any electrical parameter, pressure, volume, diameter, stretching, stretching, extension, movement, bending, elasticity, temperature and flow.

Feedback can be sent to the internal control unit or out, to an external control unit, preferably via the internal control unit.

The feedback can be sent from outside the body, through the energy transfer system, or through a separate communication system, with receivers and transmitters.

The internal control unit (1015) or, alternatively, the external wireless remote control of the external power transmission device (1004), can command / control the device (10) in response to signals from the sensor (1025). A transceiver can be combined with the sensor (1025), to send information about the detected physical parameter to the external wireless remote control.

The wireless remote control may comprise a signal transmitter or transceiver and the internal control unit (1015) may comprise a signal receiver or transceiver.

Alternatively, the wireless remote control may comprise a signal transceiver or receiver and the internal control unit (1015) may comprise a signal transmitter or transceiver.

The aforementioned transceivers, transmitters and receivers can be used to send information or correlated data to the device (10), from inside the patient's body out of it.

'B 66/105 b When the motor / pump unit (1009) and the battery (1022) for driving the motor / pump unit (1009) are implanted, the information 6 related to the battery charge (1022) can be fed back . To be more precise, when charging a battery or accumulator with energy, the feedback information related to said charging process is sent and the power supply is changed accordingly.

Fig. 36 shows an alternative embodiment in which the device (10) is adjusted from outside the patient's body. The system (1000) comprises a battery (1022) connected to the apparatus (10), via a subcutaneous electrical switch (1026). Thus, the regulation of the device (10) is carried out in a non-invasive way, by manually pressing the subcutaneous switch, so that the operation of the device (10) - is switched in the on and off modes. It should be noted that the modality shown m is simplified and that additional components, such as an internal control unit «or any other part disclosed here, can be added to the system. Two

V 15 subcutaneous switches can also be used. In the preferred embodiment, an implanted switch sends information to the internal control unit to perform a predetermined performance, and when the patient presses the switch again, performance is reversed.

Fig. 37 shows an alternative embodiment, in which the system (1000) 20 comprises a reservoir of hydraulic fluid (1013), hydraulically connected to the apparatus. A non-invasive regulation is carried out by manually pressing the hydraulic reservoir connected to the device. Alternatively, the hydraulic fluid reservoir (1013) is adapted to function as a hydraulic fluid injection port, preferably for calibrating the hydraulic fluid.

The system can include an external data communicator and an implantable internal data communicator, which communicates with the external data communicator. The internal communicator feeds data correlated to the device or the patient to the external data communicator, and / or the external data communicator feeds data to the internal data communicator.

30 Figure 38 schematically illustrates a system layout that is capable of sending information from inside the patient's body out of it, providing feedback information correlated to at least one functional parameter of the device or system, or information correlated to a

For the patient's physical parameter, in order to supply a precise amount of energy to an internal implanted energy receiver (1002), connected to the components + energy consumers implanted in the device (10). Such an energy receiver (1002) may include an energy source and / or an energy transforming device.

In

5 In summary, wireless energy is transmitted from an external energy source (1004a), located outside the patient's body and is received by the internal energy receiver (1002), located inside the patient.

The internal energy receiver is adapted to directly or indirectly supply the energy received to the energy-consuming components of the device (10), through a switch (1026). An energy balance is

10 determined between the energy received by the internal energy receiver (1002) and the energy used by the apparatus (10), and the wireless energy transmission is then controlled based on the determined energy balance.

Thus, the energy balance provides a precise indication of the correct amount of energy needed, which is sufficient for. operate the device (10) properly, without causing undue temperature rise 0

15 of the same.

In figure 38, the patient's skin is indicated by a vertical line (1005). Here, the energy receiver comprises an energy transformation device

(1002), located inside the patient, preferably just below the patient's skin (1015). In general, the energy transformation device implanted

20 (1002) can be placed in the abdomen, chest, muscle fascia (for example, in the abdominal wall), subcutaneously, or in any other suitable location.

The implanted energy transformation device (1002) is adapted to receive wireless energy

(E), transmitted from an external energy source (1004a), provided in the external energy transmission device (1004), located outside the patient's skin

25 (1005), in the vicinity of the implanted energy transformation device (1002). As is well known in the art segment, wireless energy (E) can generally be transferred via any suitable device

Transcutaneous Energy Transfer Device (TET), such as a device including a primary coil disposed on the external energy source (1004a) and a secondary coil

30 adjacent, arranged in the iniplated energy transformation device (1002). When an electric current is fed through the primary coil, energy in the form of a voltage is induced in the secondary coil, which can be used to activate the energy consuming components implanted in the device, for example,

after storing incoming energy in an implanted energy source, such as a rechargeable battery or capacitor. However, the present invention is generally not limited to any specific energy transfer technique, nor to any TET devices or energy sources, so any type of wireless energy can be used. The amount of energy received by the implanted energy receiver can be compared with the energy used by the components implanted in the device. The term "energy used" is then understood to also include the energy stored by the implanted components of the device. A control device includes an external control unit (1004b), which controls the external energy source (1004a), based on the energy balance determined to regulate the amount of energy transferred. The purpose of transferring the correct amount of energy, the energy balance and the required amount of energy are determined by means of a determination device, including an implanted internal control unit (1015), connected between the switch (1026) and the apparatus (10). The internal control unit (1015) can then be arranged to receive various measurements obtained by means of suitable sensors or similar devices (not shown), measuring certain characteristics of the device (10), somehow reflecting the required amount of energy necessary for proper operation of the device (10). In addition, the patient's present condition can also be detected by means of suitable measuring devices or sensors in order to provide parameters that reflect the patient's condition. Consequently, these characteristics and / or parameters can be correlated to the current state of the device (10), such as energy consumption, mode of operation and temperature, as well as, the patient's condition reflected by parameters, such as body temperature. , blood pressure, heartbeat and breathing. Other types of physical parameters of the patient and functional parameters of the device are described elsewhere.

In addition, an energy source in the form of an accumulator (1016) can optionally be connected to the implanted energy transformation device (1002), through the control unit (1015), to accumulate the received energy, for later use by the device (10). Alternatively or additionally, the characteristics of such an accumulator that also reflect the required amount of energy can also be measured. The accumulator can be replaced by a rechargeable battery and the measured characteristics can be correlated to the state

B 69/105 0 battery current, as well as any electrical parameter, for example, power consumption, voltage, temperature, etc. In order to provide sufficient voltage and current for the device (10), and to avoid overheating, it is clearly understood that the battery must be charged in an optimal way, upon receipt of a correct amount of energy from the implanted energy (1002), that is, an amount of energy that is not too small or too large. The accumulator can also be a capacitor with corresponding characteristics.

Thus, for example, the characteristics of the battery can be measured 10 regularly, to determine the momentary state of the battery, which can then be stored as status information in a suitable storage device, in the internal control unit (1015). Thus, whenever new measurements are made, the stored battery status information can, and consequently, be updated. In this way, the battery status can be "calibrated"

V 15 by transferring the correct amount of energy, in order to keep the battery in an Optimal condition.

Therefore, the internal control unit (1015) of the determining device is adapted to determine the energy balance and / or the amount of energy momentarily required (such as energy per unit time or accumulated energy), based on the measurements made by the aforementioned sensors or measuring devices of the apparatus (10), or of the patient or, if an implanted source of energy is used, or any combination thereof. The internal control unit (1015) is also connected to an internal signal transmitter (1027), arranged to transmit a control signal that reflects the required amount of energy, to an external signal receiver (1004C), connected to the external control unit (1004b). The amount of energy transmitted from the external energy source (1004a) can then be regulated in response to the received control signal.

Alternatively, the determination device may include the external control unit (1004b). In this alternative, the sensor measurements can be transmitted directly to the external control unit (1004b), so that the energy balance and / or the amount of energy momentarily needed can be determined by the external control unit (1004b), of this form, integrating the above described fixation of the internal control unit (1015) in the external control unit

(1004b). In this case, the internal control unit (1015) can be omitted and the sensor measurements are supplied directly to the internal signal transmitter (1027), which sends the measurements to the external signal receiver (1004C) and external control unit (1004b). The energy balance and the amount of energy currently required 5 can then be determined by the external control unit (1004b), based on said sensor measurements.

Consequently, the present solution according to the provision of figure 38 uses the feedback of the information indicating the required energy, which is more efficient than the previous solutions, because it is based on the actual use of energy 10 compared to the received energy, for example, with respect to the amount of energy, the difference in energy, or the speed of receiving energy, compared to the speed of energy used by the energy consuming components implanted in the device. The device can use the energy received, both to consume and to store the energy in an implanted source of energy or similar device. The different parameters discussed above can then be used, if it is of importance and need, and also as a tool for determining the real energy balance. However, these parameters may also be required per se, for any actions taken internally, to specifically operate the device.

The internal signal transmitter (1027) and the external signal receiver (1004C) can be implemented as separate units, using suitable signal transfer devices such as radio, infrared (IR) or ultrasonic signals. Alternatively, the internal signal transmitter (1027) and the external signal receiver (1004c) can be integrated into the implanted energy transformation device (1002) and external energy source (1004a), respectively, in order to conduct the signal signals. control in a reverse direction in relation to energy transfer, basically using the same transmission technique. Control signals can be modulated with respect to frequency, phase or amplitude.

Thus, feedback information can be transferred via a separate communication system, including receivers and transmitters, or it can be integrated into the power system. According to the present invention, such information feedback and integrated power system, comprises an internal implantable energy receiver, to receive wireless energy, the energy receiver having a first internal coil and a first electronic circuit connected to the first coil, and an external power transmitter to transmit wireless energy, the power transmitter

P energy having a second external coil and a second electronic circuit connected to the second coil. The second external coil of the energy transmitter transmits energy 5 wirelessly, which is received by the first coil of the energy receiver. This system also includes a power switch, to switch the connection of the first internal coil to the first electronic circuit in an on and off mode, so that the feedback information related to the loading of the first coil is received by the external energy transmitter in the form of an impedance variation 10 in the load of the second external coil, when the power switch switches the connection of the first internal coil to the first electronic circuit, in an on and off mode. In implementing this system, in the arrangement shown in figure 38, the switch (1026) is separated and controlled by the internal control unit (1015), or m integrated in the internal control unit (1015). It should be understood that the switch ¥ 15 (1026) must be interpreted in its broadest mode. This means a transistor, MCU, MCPU, ASIC FPGA or converter (D / A), or any other component or electronic circuit that can switch the power in an on and off mode.

To conclude, the power supply arrangement illustrated in figure 38 can basically operate as follows. The energy balance is first determined by the internal control unit (1015) of the determining device. A control signal that reflects the required amount of energy is also created by the internal control unit (1015) and the control signal is transmitted from the internal signal transmitter (1027) to the external signal receiver (1004C). Alternatively, the energy balance can be determined by the external control unit (1004b), instead of depending on the implementation, as mentioned above. In this case, the control signal can conduct measurement results from several sensors. The amount of energy emitted from the external energy source (1004a) can then be regulated by the external control unit (1004b), based on the determined energy balance, for example, in response to the received control signal. This process can be repeated intermittently at certain intervals during the progress of the energy transfer, or it can be performed on a more or less continuous basis, during the energy transfer step.

»The amount of energy transferred can generally be regulated by adjusting several transmission parameters on the external energy source.

(1004a), such as voltage, current, amplitude, wave frequency and pulse characteristics. 5 This system can also be used to obtain information about the coupling factors between the coils in a TET system, both to calibrate the system, as well as to find an optimal location for the external coil in relation to the internal coil and to optimize the transfer of energy simply by comparing, in this case, the amount of energy transferred with the amount of energy received. Thus, for example, if the external coil is moved, the coupling factor may vary and movements correctly displayed may cause the external coil to find an optimal location for transferring energy. Preferably, the external coil is adapted to calibrate the amount of energy transferred, to obtain feedback information on the determination device, before the coupling factor is maximized. . 15 This coupling factor information can also be used with feedback during energy transfer. In that case, the power system of the present invention comprises an internal implantable energy receiver for receiving wireless energy, the energy receiver having a first internal coil and a first electronic circuit connected to the first coil, and an external transmitter 20 of energy to transmit wireless energy, the energy transmitter having a second external coil and a second electronic circuit connected to the second coil. The second external coil of the power transmitter transmits wireless energy that is received by the first coil of the power receiver. This system also comprises a feedback device, for communicating the amount of energy received in the first coil as feedback information, and in which the second electronic circuit includes a determination device for receiving feedback information, and for comparing the amount of energy transferred by the second coil with the feedback information correlated to the amount of energy received in the first coil, to obtain the coupling factor between the first coil and the second coil. The energy transmitter can regulate the energy transmitted in response to the obtained coupling factor. Referring to figure 39, although the wireless transfer of power to operate the device has been described above, allowing for non-

B 73/105 b invasive, it must be noted that the device can also be operated with power connected to wires. Such an example is shown in figure 39, in which an external switch "(1026) is interconnected between the external power source (1004a) and an operating device, such as an electric motor (1007) that operates the apparatus (10) An external control unit 5 (1004b) controls the operation of the external switch (1026), to perform the proper operation of the device (10).

Figure 40 illustrates different modalities of how the energy received can be supplied and used by the device (10). Similar to the example shown in figure 38, an internal power receiver (1002) receives wireless power (E) from an external power source (1004a), which is controlled by a transmission control unit (1004b) . The internal energy receiver (1002) can comprise a constant voltage circuit, indicated by a dotted frame "Constant V" na. figure, for power supply at constant voltage to the device (10). The receiver

The internal power supply (1002) may also comprise a constant current circuit, 4 15 indicated by a dotted frame "constant C" in said figure, for supplying energy under constant current to the apparatus (10).

The apparatus (10) comprises an energy consuming part (10a), which can be an engine, pump, restriction device or any other medical accessory that requires energy for its electrical operation. The apparatus (10) may further comprise an energy storage device for storing the energy supplied from the internal energy receiver (1002). Thus, the energy supplied can be directly consumed by the energy consuming part or stored by the energy storage device, or the energy supplied can be partially consumed and partially stored. The apparatus (10) may further comprise an energy stabilization unit for stabilizing the energy supplied from the internal energy receiver (1002). Thus, the energy can be supplied in a floating manner, so that it may be necessary to stabilize the energy, before it is consumed or stored.

The energy supplied from the internal energy receiver (1002) can be further accumulated and / or stabilized by means of a separate energy stabilization unit 30 (1028), located outside the apparatus (10), before it is consumed and / or stored by the device (10). Alternatively, the energy stabilization unit (1028) can be integrated with the internal energy receiver (1002). In each case, the energy stabilization unit (1028) may comprise a constant voltage circuit and / or a constant current circuit.

W It should be noted that figure 38 and figure 40 illustrate some possible, but non-limiting, implementation options, with respect to how the 5 different components and functional elements shown can be arranged and connected together. However, a person skilled in the art will easily observe that several variations and modifications can be made within the scope of the present invention.

Figure 41, schematically, shows a 10 energy balance measurement circuit, from one of the proposed models of the system, for controlling wireless energy transmission or the energy balance control system. The circuit has an output signal centralized at 2.5 V, proportionally correlated to the energy imbalance. The derivative of this signal shows that the value oscillates upwards or downwards, and how fast this change occurs. If the amount of energy received is less than the energy used by the implanted components of the device, more energy will be transferred and, thus, charged to the energy source. The circuit's output signal is typically fed from an analog / digital converter (A / D) and converted to a digital format. The digital shape can then be sent to the external power transmission device, allowing the 20 to even adjust the level of the transmitted energy. Another possibility is to have a completely analog system that uses comparators, which compare the energy balance level with certain maximum and minimum limits, sending information to the external energy transmission device, if the balance exceeds the range of maximum or minimum values.

Figure 41, schematically, shows a circuit implementation for a system that transfers energy to the implanted energy components of the apparatus of the present invention, from outside the patient's body, using inductive energy transfer. An inductive energy transfer system typically uses an external transmitting coil and an internal receiving coil. The receiving coil (Ll) is included in schematic figure 24; the transmission parts of the system are excluded.

The implementation of the general energy balance concept and the way in which information is transmitted to the external energy transmitter can,

logically, be implemented in numerous and different ways. Schematic figure 41 and the method described above for assessing and transmitting information should only be considered as examples of how to implement the control system.

5 Circuit Details In figure 41, the symbols (Yl), (Y2), (Y3), etc., symbolize test points within the circuit. The components shown in the diagram and their respective values are values that are applied in that specific implementation and that, logically, represent only one, of an infinite number of possible design solutions.

The energy to activate the circuit is received by the energy receiving coil (Ll). The energy for the implanted components is transmitted, in this specific case, at a frequency of 25 KHz. The output signal of the energy balance is present at the test point (Yl).

Those skilled in the art will imagine that the various modalities presented above the system can be combined in different and different ways. For example, the electrical switch (1006) of figure 24 could be incorporated in any of the modalities shown in figures 27-33, the hydraulic valve bypass device (1014) of figure 27, could be incorporated in the embodiment shown in figure 26 and the gearbox (1024) could be incorporated in the modality shown in figure 25. It should be noted that the switch can simply mean any circuit or electronic component.

The modalities described in connection with figures 38, 40 and 41 identify a method and a system for controlling wireless energy transmission to the energy consuming components implanted in an electrically operable device. This method and system will be defined, in general terms, below.

Therefore, a method is provided to control the wireless energy transmission delivered to implanted energy consuming components, from an apparatus as described above. Wireless energy (E) is transmitted from an external energy source located outside the patient and received by an internal energy receiver located inside the patient, the internal energy receiver being connected to the implanted energy consuming components of the device , for

¢ 76/105 directly or indirectly supply the energy received to them. An energy balance is determined between the energy received by the internal energy receiver and the energy used to operate the device. The wireless energy transmission (E) from the external energy source is then controlled based on the given energy balance.

Wireless power can be transmitted inductively, from a primary coil in the external power source, to a secondary coil in the internal energy receiver. A change in the energy balance can be detected to control wireless energy transmission, based on the detected energy balance change 10. A difference can also be detected between the energy received by the internal energy receiver and the energy used for the medical device, to control the

B wireless power transmission, based on the detected power difference. - When controlling the transmission of energy, the amount of wireless energy. transmitted energy can be reduced if the detected energy balance modification + 15 implies that the energy balance is already increasing or vice versa. The decrease / increase in energy transmission can still correspond to a detected modification rate.

The amount of wireless energy transmitted can be further reduced, if the difference in energy detected implies that the energy received is greater than the energy used or vice versa. The decrease / increase in energy transmission can then correspond to the magnitude of the detected energy difference.

As mentioned above, the energy used to operate the medical device can be consumed to operate said medical device, and / or stored in at least one energy storage device of the medical device 25.

When electrical and / or physical parameters of the medical device and / or physical parameters of the patient are determined, the energy can be transmitted for consumption and storage, according to a transmission speed per unit of time, which is determined based on the said parameters. The total amount of energy transmitted can also be determined based on said parameters.

When a difference is detected between the total amount of energy r received by the internal energy receiver and the total amount of energy consumed and / or stored, and the difference detected is correlated to the integral over time

Ò 77/105 of at least one measured electrical parameter correlated to said energy balance, the integral can be determined for a monitored voltage and / or current, correlated to the energy balance. When the derivative is determined in relation to the time of a measured electrical parameter 5, correlated to the amount of energy consumed and / or stored, the derivative can be determined for a monitored voltage and / or current, correlated to the energy balance. The wireless energy transmission from the external energy source can be controlled by applying electrical pulses to the external energy source, starting from a first electrical circuit for wireless energy transmission, the electrical pulses having guide edges and edges of leakage, varying the lengths of the first time intervals between successive leading edges and fungus edges of the electrical pulses, and / or the lengths of the second time intervals between successive leading edges and trailing edges of the electrical pulses, and transmitting the energy wirelessly generated from the electrical pulses 15 with a varied power, the power variation depending on the lengths of the first and second time intervals. In this case, the frequency of the electrical pulses can be substantially constant when the first and / or second time intervals vary. When applying electrical pulses, the electrical pulses can remain unchanged, except when the first and / or second time intervals vary. The amplitude of the electrical pulses can be substantially constant when the first and / or second time intervals vary. In addition, the electrical pulses can be varied, only varying the lengths of the first time intervals, between successive guiding edges and furrow edges of the electrical pulses.

25 A sequence of two or more electrical pulses can be supplied in a row, so when applying the pulse sequence, the type in which the sequence has a first electrical pulse at the beginning of the sequence and a second electrical pulse at the end of the sequence , two or more pulse strings can be provided in a row, in which the lengths of the second time intervals are varied between successive 30 edges of the second electrical pulse in a first pulse sequence, and the leading edge of the first electrical pulse of a second pulse sequence. When applying electrical pulses, electrical pulses can have a substantially constant current and a voltage substantially

& 78/105 constant. Electric pulses can also have a substantially constant current and a substantially constant voltage. In addition, electrical pulses can also exhibit substantially constant frequency. The electrical pulses within a pulse sequence can also have a substantially constant 5 sequence. The circuit formed by the first electrical circuit and external energy source may have a characteristic first time period or constant first time, and when the transmitted energy is effectively varied, this time period frequency can occur in the range of the first characteristic time period or constant time, or a shorter time. A system comprising an apparatus as described above is then provided to control the wireless energy transmission provided to the energy consuming components implanted in said apparatus. In its broadest aspect, the system comprises a control device for controlling the wireless transmission of energy from a power transmission device and an internal implantable energy receiver, to receive the transmitted wireless energy, the internal energy receiver being connected to the energy consuming components implanted in the device, to directly or indirectly supply the energy received to them. The system also comprises a determination device, adapted to determine an energy balance between the energy received by the internal energy receiver and the energy used for the energy consuming components implanted in the device, in which the control device controls the energy transmission. wirelessly, from the external power transmission device, based on the energy balance determined by the determining device.

In one embodiment, at least one battery can be part or replacement of the energy transforming device (1002), to supply power to the device (10) through a supply line. In one embodiment, the battery is not rechargeable. In an alternative embodiment, the battery is rechargeable. The battery supply, of course, can be arranged remotely or built into the device.

In addition, the system can comprise any of the following items: - a primary coil in the external power source, adapted to transmit wireless energy inductively to a secondary coil in the internal energy receiver;

- the determination device is adapted to detect a change in the energy balance, and the control device controls the wireless energy transmission, based on the detected energy balance change; - the determination device is adapted to detect a difference between the energy 5 received by the internal energy receiver and the energy used for the implantable energy consumption components of the device and the control device controls the wireless energy transmission, based the difference in energy detected; - the control device controls the external power transmission device to decrease the amount of wireless energy transmitted, if the detected energy balance modification implies that the energy balance is increasing or vice versa, so the decrease / increased power transmission corresponds to a "detected modification speed;. - the control device controls the external power transmission device to. decrease the amount of wireless energy transmitted, if the difference in energy detected m

15 imply that the energy received is greater than the energy used, or vice versa, so the decrease / increase in energy transmission corresponds to the magnitude of said difference in energy detected;

- the energy used for the device is consumed to operate the device and / or stored in at least one device for energy storage of the device;

20 - when the electrical and / or physical parameters of the device and / or the physical parameters of the patient are determined, the energy transmission device transmits the energy for consumption and storage, according to a transmission speed per unit of time, which is determined by the determining device, based on said parameters.

The determination device also determines the total amount of

25 energy transmitted based on said parameters; - when a difference is detected between the total amount of energy received by the internal energy receiver and the total amount of energy consumed and / or stored, and the difference detected is correlated to the integral with respect to the time of at least one correlated measured electrical parameter to the energy balance, the

30 determination determines the integral for a monitored voltage and / or current, correlated to the energy balance; - when the derivative is determined in relation to the time of a measured electrical parameter correlated to the amount of energy consumed and / or stored, the determination device determines the derivative for a monitored voltage and / or current, correlated to the energy balance; - the energy transmission device comprises a coil placed externally to the human body, and an electrical circuit is provided to drive the coil

5 external with electrical pulses, so as to transmit energy wirelessly.

The electrical pulses have guide edges and flange edges, and the electrical circuit is adapted to vary the first time intervals between successive guide and flange edges, and / or second time intervals between successive guide or flange edges of the electrical pulses, to vary the power of the wireless energy transmitted.

As a result, the energy receiver that receives the transmitted wireless energy is of varying power; - the electrical circuit is adapted to release the electrical pulses so that they remain unchanged, except with the variation of the first and / or second time intervals; - the electrical circuit has a constant time, being adapted to vary the first and second time intervals only in the range of the first constant time,

so that when the lengths of the first and / or second time intervals are varied, the power transmitted over the coil is varied;

- the electrical circuit is adapted to release the electrical pulses for variation, only by varying the lengths of the first time intervals, between successive guide edges and furrow edges of the electrical pulses;

- the electrical circuit is adapted to provide a sequence of two or more electrical pulses in a row, said sequence presenting a first electrical pulse at the beginning of the pulse sequence and a second electrical pulse at the end of the pulse sequence; and the lengths of the second time intervals between successive flange edges of the second electrical pulse in a first sequence of pulses, and the leading edge of the first electrical pulse of a second sequence of pulses, are varied by the first electronic circuit;

- the electrical circuit is adapted to provide electrical pulses as pulses having a height, and / or amplitude, and / or intensity, and / or voltage, and / or current, and / or frequency,

substantially constant;

- the electrical circuit has a constant time, being adapted to vary the first and second time intervals only in the range of the first constant time,

so that when the lengths of the first and / or second time intervals are varied, the power transmitted over the first coil is varied;

and 81/105 b - the electrical circuit is adapted to provide electrical pulses, varying the lengths of the first and / or second time intervals only within a range that includes the

P first constant time, or that is located relatively close to the first constant time, compared to the magnitude of the first constant time.

5 Figures 42-45 show, in greater detail, block diagrams of four different hydraulic or pneumatic actuation modes, activating an implanted device according to the invention.

Figure 42 shows a system as described above. The system comprises an implanted apparatus (10) and a separate regulating reservoir 10 (1013), a one-way pump (1009) and a reciprocal valve (1014). Figure 43 shows the apparatus (10) and a fluid reservoir (1013). When 'moving the regulating tank wall or changing its size. for any other different, the adjustment of the device can be carried out without any

N valve, just by the simple passage of fluid, at any time, through the movement of the reservoir wall. Figure 44 shows the apparatus (10), a two-way pump (1009) and the regulating reservoir (1013). Figure 45 shows a block diagram of a servo inverted system, with a first closed system controlling a second closed system. The servosystem comprises a regulating reservoir (1013) and a servo reservoir (1050). The servo-reservoir (1050) mechanically controls an implanted device (10), through a mechanical interconnection (1054). The device has an expandable / contractable cavity. This cavity is preferably expanded or contracted through the supply of hydraulic fluid from the largest adjustable reservoir (1052), in a fluid connection with the apparatus (10). Alternatively, the cavity contains compressible gas, which can be compressed and expanded under the command of the servo reservoir (1050). The servo reservoir (1050) can also be part of the device itself.

30 In one embodiment, the regulation reservoir is placed subcutaneously under the patient's skin, being operated by pushing the external surface of the patient, using a finger. This system is illustrated in figures 46a-46c. In figure 46a, a flexible subcutaneous regulation reservoir is shown

O

82/105

(1013), connected to a domed-shaped servo-reservoir (1050), through a conduit (1011). This bowl-shaped or bellows-shaped servo-reservoir (1050) is comprised of a flexible device (10). In the state shown in figure 46a, the servo reservoir (1050) contains a minimum amount of fluid and the largest amount of

5 nuido is found in the regulating reservoir (1013). Due to the mechanical interconnection between the servo-reservoir (1050) and the device (10), the external shape of the device (10) is contracted, that is, it occupies less than its maximum volume.

This maximum volume is shown with dashed lines in the figure.

Figure 46b shows a state in which a user, such as the

10 patient in which the device is implanted, presses the regulating reservoir (1013), so that the fluid contained therein is brought to circulate through the conduit (1011) and inside the servo-reservoir (1050), which, thanks to the its bellows shape, expands longitudinally.

This expansion, in turn, expands the device (10), in order to occupy its maximum volume, thus, stretching the stomach wall (not

15 shown) that are available in contact.

The regulating reservoir (1013) is preferably provided with a device (1013a) to maintain its shape after compression.

This device, which is shown schematically in the figure, will then keep the device (10) in a stretched position, too, when the user releases the regulation reservoir.

Of that

In this way, the regulating reservoir essentially functions as a toggle switch, on and off type, for the system.

An alternative mode of hydraulic or pneumatic operation will now be described with reference to figures 47 and 48a-c.

The block diagram shown in figure 47 comprises a first closed system, which controls a second system

25 closed.

The first system comprises a regulating reservoir (1013) and a servo reservoir (1050). The servo-reservoir (1050) mechanically controls a larger adjustable reservoir (1052), through a mechanical interconnection (1054). An implanted device (10) having an expandable / contractible cavity, in turn, is controlled by the largest adjustable reservoir (1052), by means of fluid supply

30 hydraulic of the largest adjustable reservoir (1052), in fluid connection with the device

(10). An example of such an embodiment will now be described with reference to figures 48a-48c.

As in the previous modality, the regulation reservoir is placed

The 83/105

D subcutaneously, under the patient's skin, being operated by pushing the external surface of the patient through a finger. The regulating reservoir (1013) is in fluid connection with a bellows-shaped servo-reservoir (1050) via a conduit (1011). In the first closed system (1013, 1011, 1050) shown 5 in figure 48a, the servo reservoir (1050) contains a minimum amount of fluid and the largest amount of fluid is found in the regulating reservoir (1013).

The servo-reservoir (1050) is mechanically connected to a larger adjustable reservoir (1052), in the present example, also having a bellows shape, but with a larger diameter than the servo-reservoir (1050). The largest 10 adjustable reservoir (1052) is in fluid connection with the device (10). This means that when a user pushes the regulating reservoir (1013), in this way, displacing fluid from the regulating reservoir (1013) to the servo-reservoir. (1050), the expansion of the servo-reservoir (1050) will displace a larger volume of fluid

P for the largest adjustable reservoir (1052) for the device (10). In other words, in this servo-inverted mechanism, a small volume in the regulation reservoir is compressed with a greater force and this creates a movement of a larger total area, with less force per unit area. As in the previous embodiment described above with reference to figures 46a-46c, the regulating reservoir (1013) is preferably provided with a device (1013a) for maintaining its shape after compression. This device, which is shown schematically in the figure, will then keep the device (10) in a stretched position, too, when the user releases the regulation reservoir. In this way, the regulating reservoir essentially functions as an on / off toggle switch for the system. 25 A single volume filling device has been described as sheathed in the stomach wall. Alternatively, two or more volume filling devices (10) can be sheathed to obtain the desired reduction of the food cavity. An example of this is illustrated in figure 49, where three ball-shaped volume filling devices (10) are sheathed on a patient's stomach wall 30 (12). Thus, it has been described how the volume filling device (10) is sheathed in the stomach wall by means of a gastroscopic instrument. It should be noted that abdominal operating methods may also be used. These methods will now be described in greater detail, with reference to figures 50a and 50b. Figure 50 shows an embodiment of an apparatus according to the invention.

Figure 50 shows the segments of a volume filling device

5 to be assembled before implantation in a patient, in need of obesity treatment.

The segments of the volume filling device include a core part (560) and four outer parts (561a-561d). The generally cylindrical core part is provided with an upper part (560 ') and provided with four slits (562a-562d), which are symmetrically distributed and extend along the outer perimeter of the part

10 from the core.

The outer parts (561a-561d) are shown, generally, as part of a sphere having an inner surface and an outer surface, and each part

- being provided with a projecting flange (563a-563d), which extends along the. internal surface.

The flanges (563a-563d) flush with the slots (562a-562d) in the. illustrated mode, however, can be arranged with fixed inserts between the flanges

15 and the slits, so that the assembled volume filling device is sufficiently installed in its target implantation position, above the cardia.

If the volume filling device is inadvertently moved from its position to the stomach cavity, a loose fitting arrangement contributes to a faster disassembly of its segments.

The core part is connected to a wire

20 guide (564), which extends through a first channel (565) in the core part, through a corresponding channel (565a), between two neighboring holes in the projection element (563a), in the first external part (561a ). When operating the guide wire (564) by moving it away from the upper surface of the core part (560 '), the first outer part (561a) will be moved towards the core part and the flange

25 (563a) will meet with the slot (562a), so that the first outer part is mounted on the core part (560). As shown in figure 51, this performance is repeated with the second external part, now, through the guide wire (564)

through the second channel (566), connected to a corresponding channel on the flange (563b) of the second external part (561b). Figure 52 shows this performance again for

30 mounting the third outer part (561c), with the third channel (567) connecting the guide wire (564) to the flange (563c). Figure 53 shows the fourth and last outer part (561d) being mounted through the flange (563d) and channel (568). Figure 54 shows the volume filling device finally assembled.

Figure 55 is a more detailed view

G 85/105 of the core part, showing the channel system for the guide wire. Figures 55b to 55d represent cross-sectional views of the planes I-I, II-II, III-III and IV-IV, respectively, each plane at the level of the four channels. The guide wire is made of a biodegradable material, which is decomposed, so that the segments become easily disassembled, should the volume filling device, accidentally, become displaced from its implanted position. The illustrated segments are made of a solid biocompatible material, each of a certain size and shape, so that they pass easily through the gastrointestinal system, in case the volume filling device is disassembled.

When implanting said assembled volume filling device, any of the methods described above will be suitable.

Fig. 56 shows an embodiment of the volume filling device to be assembled. The contour of the core part and the segments is identical to that shown in figure 50, but the flanges (563a-563d) of the segments are provided with 15 recesses (563'a-563'd), which are flush with the projection elements (562'a-562'd) of the slits (562a-562d) of the core part, thus, the movement restriction device becomes locked along different planes. In the present modality, these plans are arranged perpendicular to each other. Fig. 57 shows another modality of the volume filling device, according to Fig. 56, without the presence of any guide wire and without any characteristics for the guide wire in the segments. This modality requires that leveling element locking elements be adapted to assist disassembly, should the volume filling device inadvertently become displaced from its implanted position.

A method of injecting or inserting a plurality of segments of volume filling devices into a pouch formed by a part of a stomach wall will now be described with reference to figures 58a-58d. In this example, a volume filling device will be used, as described above, with reference to figure 50. A tube-shaped instrument, generally referenced by (600), such as that illustrated in figure 4b, comprises a sleeve (60Oa ), having a diameter and shape of cross section, in order to allow the passage of the core part (560) and the four external parts (561a-561d). A piston (602) is provided to move the segments of the volume filling device through the sleeve (60Oa) and within a certain space, in which the segments of the filling device

The volume 86/105 must be mounted inside the volume filling device or provide the formation of such a device. As shown in figure 58a, in this example, the instrument (600) is used to insert or inject the segments of the volume filling device through a hole (12a) in a stomach wall portion 5 (12) of a patient. As shown in figure 58b, the guide wire (564) forces the outer parts (561a-561d) to take a respective petal-like position, to allow the core part (560) to take a position that allows the outer parts (561a-561d ) and the core part (560) are installed within a substantially spherical volume filling device 10 (10). When pulling the guide wire (564) (as seen in figure 58c), the outer parts (561a-561d) are moved together with the core part (560), being held in position by means of interlocking flanges (563a- 563d).

After being completely sheathed, as seen in figure 58d, the substantially spherical volume filling device (10) is sheathed in part of the stomach wall (12) by means of sutures or staples (14). The limited space of the pouch formed by the stomach wall prevents the volume filling device (10) from collapsing, even after the biodegradable guide wire (564) has been decomposed. However, in the event that the volume filling device (10) becomes 20 hax, due to the possible rupture of the sutures or staples (14), said volume filling device will collapse, so that the different segments, each of them being smaller than the mounted volume filling device (10), they can pass through the gastrointestinal system. It is evident that according to the general description presented here and also according to the appended claims, many other ways of designing the volume filling device are possible, without departing from the present concept. One such way is to let a relatively small plurality of volume filling device segments form a volume filling device, which will now be described with reference to figures 59a-59c.

The present method of injecting or inserting segments of volume filling devices into a bag is similar to that described with reference to figures 4a-4d, after a bag has been created in the stomach wall. Thus, figure 59 illustrates a stomach wall portion (12a), after sutures or staples (14) have been applied, to create a pouch in the stomach wall. The bag can be provided using the method described above, with reference to figures 5a-5i. © Thus, segments of volume filling devices (10) are inserted or injected into the bag by means of a gastroscopic or 5 tube-shaped laparoscopic instrument (600), such as the instrument illustrated in figure 4b. The instrument comprises an outer sleeve and an inner sleeve (see figure 4b), which can be moved longitudinally in relation to the outer sleeve. The inner sleeve is provided with a cutting element in the form of a cutting edge (615), at the furthest end of it. This cutting edge can be used to cut a hole in the stomach wall, as will be explained in more detail below. When the instrument reaches a stomach wall, the inner sleeve is brought up from its position in the outer sleeve, and comes into contact with the stomach wall (12a). The cutting edge (615) of the inner sleeve then cuts a hole in the wall. stomach, in order to allow subsequent insertion of the filling devices - 15 of volume (10) into that tube, as seen in figure 59b. In order to push the volume filling device through the tube, a piston (602) can be provided in the instrument. Thus, the instrument further comprises a piston (602), adapted to propel a plurality of volume filling devices (10) out of a position in the inner sleeve, that position being shown in figure 59a, to a position outside the uva internal, as shown in figure 59b. In order to protect the deflated volume filling device (10) from the cutting edge (615) of the inner sleeve, an additional protective sleeve (not shown) can be provided around the volume filling device. The tube-shaped instrument (600) in the embodiment shown is provided with a cup-shaped extension, holding the pouch in place, during insertion of the volume filling device segments (10) into the pouch. During the process of gradually withdrawing the tube-shaped instrument (600), as seen in figure 59b, the bag can be filled with the volume filling device segments (10) in a controlled manner.

30 After the pouch has been filled with segments of volume filling devices to a desired degree, as seen in figure 59C, the furrow (12b) cut into the stomach wall (12a) by means of the tube-shaped instrument (600) in

¢ 88/105 permanently closed, for example, through suturing or stapling procedures. In the embodiment shown in figures 59a-59c, the tube-shaped instrument (600) comprises a piston (602), adapted to push or move the 5 segments of volume filling devices (10) along the sleeve (60Ob). Alternatively, as shown in figure 59, the pressure exerted by the noise can be used to boost or displace the segments of volume filling devices (10).

The volume filling device segments (10) can take several different shapes. In the embodiments shown in figures 58a-58c and 59, they are substantially spherical. However, in alternative modalities, they exhibit one or a plurality of flat or substantially flat surfaces.

Preferably, these segments can take the form of polyhedra, such as, for example, tetrahedrons, hexahedrons, octahedrons, dodecahedrons or icosahedrons, i.e., regular polyhedra 15 with four, six, eight, twelve and twenty flat surfaces, respectively. These examples of volume filling device segments are shown in figures 61a-61e.

The volume filling devices can, in addition, be kept in a mutual relationship by means of additional measures. Thus, for example, the surfaces of the volume filling device segments may be provided with a friction-enhancing agent or a material to minimize slippage of the volume filling device segments. The friction enhancing agent can be some type of glue or the like. Alternatively, or in addition, the surface or surfaces of the volume filling device segments 25 may receive a rough texture, to increase friction between adjacent volume filling device segments.

As mentioned above, the volume filling device (10) can be inflated with a gel or fluid, supplied inside a chamber, defined by the volume filling device (10), as seen in figure 62. Insertion 30 or injection of a plurality of volume filling device segments (10) within a natural pouch provided by a stomach wall portion (12), has been described above with reference to figures 59a-59d. However, in an alternative modality of an obesity treatment device, the device segments

± · 'Z: volume filling devices may also comprise a volume filling device segment for collecting two or more other volume filling devices segments, which are of a different type. Thus, the apparatus comprises a second "expandable volume filling device segment (10 '), for collecting 5 of two or more first volume filling device segments (10), different from the second filling device segment volume, wherein the second segment of the volume filling device and the first segments of the volume filling device when together form said volume filling device. It is preferred that the second segment of the volume filling device be flexible or stretchable In an alternative embodiment, to allow the remodeling of the volume filling device, a friction reducing fluid may be available to reduce friction between adjacent segments of volume filling devices.

? K In figure 64, it is shown how a plurality of segments of volume filling devices (10) is provided in a pouch created by part of a stomach wall (12), with a fluid having been injected into that pouch, which allows a mutual movement between the first segments of adjacent volume filling devices, so that the shape of the volume filling device is adapted to the movements of the stomach wall, when said and the volume filling device is sheathed on a stomach wall. a The modalities of figures 63 and 64 can be combined, so that an external segment of the volume filling device (10 ') includes a plurality of different segments of volume filling device (10), in this case, spherical as well as a fluid that reduces friction between the 25 different volume filling device segments. The nuance described above can, instead of reducing the friction between segments of adjacent volume filling devices, intensify the friction between segments of adjacent volume filling devices, thereby making the volume filling device more stable. The friction enhancing material can also be a glue or an adhesive, i.e., a solidifying agent. The segments of volume filling devices, adapted to be used as a plurality arrangement, to form a volume filling device, have been described above with reference to figures 59a-59c and 59a-

59e. It should be noted that these segments of volume filling devices may receive the same properties as the volume filling devices "described above, with respect to materials, properties, etc.

In a first alternative embodiment, the 5-volume filling device is implanted using a laparoscopic method, using the intraluminal method described above. According to this modality, an instrument in the form of a tube or needle is inserted into the abdomen of a patient's body, and said instrument in the form of a tube or needle is then used to fill the patient's abdomen with gas.

Then, at least two laparoscopic trocars are inserted into the patient's body; and a chamber is inserted through one of said at least two laparoscopic trocars. Then, at least one dissection instrument is inserted, through one of the said at least two laparoscopic trocars, and an area of the stomach is dissected. The volume filling device is then inserted into the abdominal cavity and placed outside the stomach wall. So, b ..

15 a pouch on the stomach wall for the device, and the device is sheathed in said pouch by providing sutures or staples on the stomach wall, thereby positioning the volume filling device, so that the volume of the food cavity is reduced in size by a volume that substantially exceeds the volume of said volume filling device. The first alternative described above, preferably, further comprises fixing the device to the stomach wall, by providing sutures or staples. The above embodiment preferably further comprises the provision of an apparatus for regulating the obesity treatment device from outside a patient's body; and operating said apparatus to regulate the obesity treatment device. In addition, regulation of the obesity treatment device includes changing the volume of a filling body of the volume filling device, when implanted.

The above embodiment, preferably, further comprises the provision of an injector-type syringe, comprising a fluid for injection into an implanted filling body, with the injection of the volume of fluid within said filling body.

y 91/105 According to one embodiment, the device is included or partially included in the bag, so the bag is left at least partially open. In addition, the bag can be designed to display only one opening. Alternatively, the pouch is designed to exhibit two openings and extend non-perimetrically around the stomach. Preferably, the pouch has a volume span of more than 15 mm.

In a second alternative, also using a laparoscopic method instead of an intraluminal method, the initial steps are the same as those described in the first alternative, but, after dissecting the stomach, a hole is created in the stomach wall and a volume filling is introduced into the abdominal cavity, through said furo, into the stomach. The device is placed inside the stomach wall, and a pouch is created outside the stomach cavity, to arrange the device placed inside the stomach wall, and the device is sheathed in the pouch by providing sutures or staples on the wall. of the stomach, thereby, positioning said volume filling device, 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.

The above-described embodiment, preferably, further comprises fixing the device to the stomach wall, by providing sutures or staples. According to one embodiment, the stomach wall is attached to the lower part of the patient's esophagus, by providing sutures or staples.

The second alternative presented above, preferably, further comprises the provision of an apparatus for regulating the obesity treatment device, 25 outside the patient's body; and operating said apparatus for regulating the obesity treatment device. In addition, regulation of the obesity treatment device includes changing the volume of a filling body of the volume filling device when implanted.

The above embodiment preferably further comprises the provision of an injector-type syringe, comprising a fluid for injection into an implanted filling body, with a fluid injection volume within said filling body.

D According to an embodiment, the device is included or partially included in the bag, whereby the bag is left at least partially open. Beyond

In addition, the bag can be designed to display only one opening. Alternatively, the pouch is designed to show two openings and extend non-perimetrically around the stomach. Preferably, the pouch has a volume span of more than 15 mm. A third alternative involves a surgical incision, instead of the intraluminal or laparoscopic method. Here, an opening is made in the patient's abdominal wall 10 through a surgical incision, and an area of the patient's stomach is dissected. The volume filling device is introduced through the said "abdominal incision and fixed to the stomach wall, thereby providing the # # positioning of the volume filling device, so that the volume of the food cavity is reduced in size, by a volume that substantially m 15 exceeds the volume of the volume filling device.In an alternative embodiment to the above, that is, the third alternative, the initial steps are the same, including the dissection of an area of the stomach. a pouch for the device is created on the stomach wall, whereby the device is sheathed in the pouch by providing sutures or staples on the stomach wall, thereby providing the positioning of the volume filling device, 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.

In another alternative embodiment of the above, the third alternative, 25 the initial steps are the same, including the dissection of an area of the stomach. Following this, a hole is created in the stomach wall and the volume filling device is introduced through the head into the stomach. The device is then placed inside the stomach wall, and a pouch for the device is created on the stomach wall. The device is then sheathed in the pouch by providing 30 sutures or staples on the stomach wall, thereby providing the positioning of the volume filling device, 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.

The modalities described above of the third alternative also include fixing the device to the stomach wall, by providing sutures or staples. The embodiment presented above, preferably, further comprises the provision of an apparatus for regulating the obesity treatment device, from outside the patient's body; and operating said apparatus for regulating the obesity treatment device. In addition, regulation of the obesity treatment device includes changing the volume of a filling body of the volume filling device when implanted.

The above embodiment, preferably, further comprises the provision of an injector-type syringe, comprising a fluid for injection into an implanted filling body, with a fluid injection volume within said filling body.

According to an embodiment, the device is included or partially included in the bag, whereby the bag is left at least partially open. In addition, the bag can be designed to display only one opening. Alternatively, the pouch is designed to exhibit two openings and extend non-perimetrically around the stomach.

Preferably, the pouch has a volume span of more than 15 mm. A fourth alternative embodiment comprises a method that includes the steps of inserting an instrument in the form of a tube or needle into the abdomen of a patient's body, using said tube or needle-like instrument to fill the patient's abdomen with gas; placing at least two laparoscopic trocars on the patient's body; insert a camera through one of the said at least two laparoscopic trocars into the patient's abdomen; insert at least one dissection instrument through one of the said at least two laparoscopic trocars; dissect an area of the stomach; create a pouch from the stomach wall for the device; close the bag by providing sutures or staples; introducing an injection element comprising an injectable filling material; and inject the

J filling material inside the bag, thereby creating a filling body that fills a volume in the patient's stomach, reducing the size cavity,

»

94/105 for a volume that substantially exceeds the volume of the volume filling device.

Instead of the laparoscopic method disclosed above, a surgical incision or opening is cut into the skin to enter the patient's abdomen; an area of

5 stomach is dissected; a pouch is created from the stomach wall for the device, and said pouch is closed by providing sutures and staples.

An injection element comprising an injectable filling material is then introduced, the filling material being injected into the pouch, thereby creating a filling body that reduces the size of the food cavity by one

10 volume that substantially exceeds the volume of the volume filling device.

According to an alternative embodiment of the above, the pouch is created outside the stomach wall, with the filling body being placed against the inside of the stomach wall.

The method according to any of the two previous modalities

15 comprises the creation of a hole in the stomach wall, in which a pocket is created inside the stomach wall, with the filling body being placed against the outside of the stomach wall.

The method according to any of the two previous modalities, can also include the fixation of the stomach wall in the lower esophagus

20 of the patient, through the provision of sutures or staples, or the fixation of the stomach wall to the patient's diahagma muscle or other muscle tissue.

Preferably, the pouch has a volume span of more than 15 mm.

In a method according to either of the two modalities

25, the filling material is preferably capable of undergoing a curing process, going from a fluid state to a semi-solid or solid state.

Preferably, said curing process is triggered by an increase in temperature, from room temperature to body temperature.

The invention also makes available a method of treating

30 obesity in a patient, through the implantation of a volume filling device, which when implanted in the patient reduces the size of the food cavity, by a volume that substantially exceeds the volume of the volume filling device, the method comprising the steps of: inserting an instrument in the form of a tube or needle into the abdomen of a patient's body; using said tube or needle type instrument to fill the patient's abdomen with gas; placing at least two laparoscopic trocars on the patient's body; placing at least two laparoscopic trocars on the patient's body; insert a camera through one of the said at least two laparoscopic trocars into the patient's abdomen; insert at least one dissection instrument through one of the said at least two laparoscopic trocars; dissect an area of the stomach; create a line in the stomach wall; insert a device into the abdominal cavity; insert the device through the hole inside the stomach; placing the device outside the stomach wall; securing the device placed externally to the stomach wall, thereby creating a filling body that reduces the size of the food cavity by a size that substantially exceeds the volume of the volume filling device. In the method set out above, the device is preferably attached to the stomach wall by providing sutures or staples.

The invention also comprises a laparoscopic instrument for providing a volume filling device to be sheathed in the stomach wall of a human patient, for treating obesity, suitable for use with any of the laparoscopic methods described above, the instrument comprising: an elongated element having a nearer and a farther end, the elongated element having a smaller diameter than the laparoscopic trocar, to be introduced into the patient's abdomen during a laparoscopic operation; a stomach boosting device for pushing the stomach wall to create a tube-shaped shaped portion of the stomach wall, which protrudes into the normal stomach cavity, said boosting device comprising the volume filling device to be sheathed by the stomach wall in the tube-shaped portion thereof; wherein the boosting device comprises a vacuum device to suck the stomach fluid out, to assist the instrument in forming the tube-shaped patterned portion of the stomach wall, together with the boosting device, and where the vacuum device comprises a vacuum passage from the nearest end to the farthest end of the instrument and the terminal portion of the instrument, including the boost device, said vacuum passage being divided into multiple small openings, adapted to suck the stomach wall portion, to become adherent to the boosting device, to later form the tube-like portion of the stomach; and further in that the instrument comprises an insertion device, adapted to introduce the volume filling device into the tube shaped portion of the stomach. Such an instrument preferably comprises at least one clamping device to support the opening of the substantially closed tube-shaped portion by the joint stomach-to-stomach clamping in said opening, wherein the instrument is adapted to place said at least one device tightening in the opening, so that it allows a posterior suture of the opening In addition, the instrument preferably comprises an insufflation device to inflate the volume filling device before or after the suture procedure. In addition, preferably, the instrument comprises a suture device, adapted to suture the opening of the tube-shaped portion with stomach-to-stomach connection sutures, to create, at least partially, an enclosed space including the volume filling device , in which the instrument is adapted to be removed, leaving the volume filling device at least partially sheathed in the stomach wall. Said suturing device preferably comprises a first and second suture positioning element, provided in the elongated element located in the stomach, at the farthest end of the same, and in which the instrument further comprises an operating device, adapted to adjust the first and second suture elements, in a position where the positioning elements of the first and second sutures meet the stomach wall, on both sides of the open end of the cup-like portion, and adapted to suture the end opening of the bowl-like portion of the wall with a row of stomach-to-stomach sutures.

Preferably, the suture device comprises a multi-suture device operable in a rechargeable manner, being refillable with sutures outside the patient's body, and which is adapted to suture the open end of the cup-like portion of the wall with said row of sutures of stomach-to-stomach connection, wherein said row of sutures comprises two or more sutures or staples, to be sutured simultaneously.

More preferably, said suture device comprises multiple sutures, to suture two or more sutures simultaneously.

Thus, the invention comprises a method or part of method, to be used in any combination and using any apparatus or part of apparatus, or any characteristic in any combination, where the following method steps are applicable, said method may comprise a or more of the following operational steps: - introducing said instrument into the throat; - pass the instrument through the esophagus; - place an anvil or a unit to release fixation elements in the esophagus, between the cardia and the level of the diaphygm, to connect with the fixation of the esophagus to the stomach tissue; - lower the instrument further into the esophagus and, later, further into the stomach; - fill the stomach with gas to expand it; - suck fluid from the stomach; - observe in a guide view when said instrument comprises a camera; - connect the instrument with the stomach; - create and suture at least one pouch from the stomach wall; - filling said at least one pocket with fluid and / or a volume filling device, or two or more volume filling devices; - releasing a plurality of volume filling devices within said pouch created in the stomach tissue, through a tubular element;

- pass through the stomach wall with said instrument; - passing through the stomach wall with said instrument, for placing a volume filling device outside the stomach wall; - pass through the stomach wall with said instrument, for placement of a tube that allows the placement of a subcutaneous injection port;

- place a subcutaneous injection port; - suture or staple the stomach wall, from the inside to the esophagus; - suture or staple the stomach wall connection to the stomach wall, from the inside of the stomach;

- connect the instrument with the esophagus; - suture or staple a layer of stomach tissue to a layer of esophageal tissue; - suture or staple two layers of stomach tissue to one layer of the stomach tissue

Esophagus; - suture or staple three layers of stomach tissue to a layer of esophageal tissue;

- suture or staple four layers of stomach tissue to a layer of esophageal tissue;

- suture or staple one or more layers of the stomach tissue to two or more positions in the esophageal tissue, the esophagus having a central esophageal axis, the esophagus also having a substantially cylindrical internal and external surface that extends radially in relation to the axis esophageal tissue, and where the stomach tissue is attached to the esophageal tissue at a first point along a first axis of esophageal surface extension, substantially parallel to said central esophageal axis, and at a second point along a second esophageal surface extension axis, substantially parallel to said central esophageal axis, at a distance from said first esophageal surface extension axis, radially in relation to said central esophageal axis;

- release the fastening elements by means of a unit placed on said instrument; - penetrate at least one layer of the stomach tissue and one layer of the esophageal tissue with said fixing elements; - placing said fixation elements above the gastroesophageal junction, to create an elongated passage between the esophagus and the stomach, above said junction;

- place a part of the esophagus in the esophagus and a part of the stomach in the stomach; - placing the fixation element substantially between the stomach and the esophageal part; - inserting said instrument into the main cavity of the stomach through the cardia, adapted to direct the instrument in the cranial direction, to reach a position of said unit above said junction;

- allow a substantially unrestricted contraction to the elongated passage and release it from the sphincter muscle that closes the cardia placed in said junction, when such an elongated passage has been created.

The invention comprises a method or part of method, to be used in any combination and using any apparatus or part of apparatus, or any characteristic in any combination, where the following method steps are applicable, wherein said method comprises one or more following steps

5 operational: - cut a patient's skin; - create an opening in the patient's abdominal wall; - introducing said instrument into the abdominal cavity, through said opening in the abdominal wall;

10 - connect the instrument with the stomach; - press the instrument down into the stomach wall, in order to create at least one pre-shaped stomach wall pouch; - staple the stomach wall in order to create at least one pre-shaped stomach wall pouch;

15 - suture or staple at least one pouch to the stomach wall; - filling said at least one pocket with fluid and / or a volume filling device, or two or more volume filling devices; - releasing a plurality of volume filling devices within said pouch created in the stomach tissue, through a tubular element;

20 - pass through the stomach wall, inside the stomach, with said instrument; - passing through the stomach wall with said instrument, for placing a volume filling device inside the stomach wall;

- pass through the stomach wall with said instrument, to suture the stomach wall to the esophageal wall;

25 - placing a volume filling device outside the stomach wall; - sheathing said volume filling device against the stomach wall;

- place a subcutaneous injection port; - suture or staple the stomach wall with the stomach wall outside the stomach; 30 - suture or staple the stomach wall with the stomach wall outside the stomach, without penetrating the mucosa; - suture or staple two layers of the stomach wall to one or two layers of the stomach wall;

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- connect the instrument with the esophagus; - squeeze both sides of the esophagus, to attach a layer of esophageal wall to the stomach tissue; - tighten both sides of the esophagus and the back wall of the stomach to create a

5 layer of esophageal wall to one or two layers of stomach tissue; - introducing a tube or gastroscopic instrument into the esophagus, comprising an anvil element or a fixation release element, which is involved in fixing the esophagus to the stomach;

- coordinate the position of the anvil element or a fixing release element

10 inside the esophagus, in relation to said tightening instrument, around the esophagus; - suture or staple a layer of stomach tissue to a layer of esophageal tissue;

- suture or staple two layers of stomach tissue to a layer of esophageal tissue;

15 - suture or staple three layers of stomach tissue to a layer of esophageal tissue;

- suture or staple four layers of stomach tissue to a layer of esophageal tissue;

- promote stapling using stapling elements of different sizes

20 stapling properties, in different positions, in a row of stapling elements;

- staple the stomach to the esophagus with a first stapling depth and staple the stomach with a second stapling depth; 25 - stapling a pouch with sutures connecting stomach to stomach in a row of stapling elements, also comprising stapling the esophagus with stapling elements of greater depth, included as part of the said stapling line;

- suture or staple one or more layers of stomach tissue into two or more

30 positions in the esophageal tissue, the esophagus having a central esophageal axis, the esophagus also having a substantially cylindrical internal and external surface that extends radially in relation to the central axis of the esophagus, and in which the stomach tissue is attached to the tissue esophageal at a first point along a first axis of esophageal surface extension, substantially parallel to said central axis of the esophagus, and at a second point along a second axis of esophageal surface extension, substantially parallel to said axis central esophagus, at a distance from said first esophageal surface extension axis, radially in relation to said central esophageal axis; - release the fastening elements by means of a unit placed on said instrument; - penetrate at least one layer of the stomach tissue and one layer of the esophageal tissue with said fixing elements; - placing said fixation elements above the gastroesophageal junction, to create an elongated passage between the esophagus and the stomach, above said junction; - allow the elongated passage to have a substantially unrestricted contraction and release it from the sphincter muscle that closes the cardia placed in said junction, when such an elongated passage has been created; - place a part of the esophagus in the esophagus and a part of the stomach in the stomach, through an introduction into the stomach cavity; - placing the fixation element substantially between the stomach and part of the esophagus; - inserting said instrument into the main cavity of the stomach, below said junction and being adapted to direct the instrument in the cranial direction, to reach a position of said unit above said junction; - operating a joint comprised in said instrument, to enable said instrument to be inserted into the main cavity of the stomach, bending said joint in a certain direction, in order to reach a position of said part of the unit in the esophagus, above said joint.

The invention comprises a method or part of method, to be used in any combination and using any apparatus or part of apparatus, or any characteristic in any combination, where the following method steps are applicable, wherein said method comprises one or more of the following laparoscopic operational steps: - cutting a patient's skin; - insert a tube through the abdominal wall; - fill the abdominal cavity with fluid or gas; - introduce two or more trocars into the abdominal cavity; - insert a camera into the abdominal cavity through one of the trocars;

q - introducing said instrument into the abdominal cavity through one of the trocars; ~ - connect the instrument with the stomach; - lowering the instrument into the stomach wall to create at least one precast stomach wall pouch 5; - tightening the stomach wall to create at least one pre-shaped stomach wall pouch; - suture or staple at least one pouch to the stomach wall; - filling said at least one bag with fluid and / or a volume filling device 10, or with two or more volume filling devices; - releasing a plurality of volume filling devices within said pocket. created in the stomach tissue, through a tubular element; - pass through the stomach wall, inside the stomach, with said instrument; . - pass through the stomach wall with said instrument, for placing a + 15 volume filling device inside the stomach wall; - passing through the stomach wall with said instrument, to suture the stomach wall to the esophageal wall; - place a volume filling device outside the stomach wall; - sheathing said volume filling device on the stomach wall; 20 - place a subcutaneous injection port; - suture or staple the stomach wall with the stomach wall outside the stomach; - suture or staple two layers of stomach wall to one or two layers of stomach wall; 25 - suture or staple the stomach wall with the stomach wall outside the stomach, without penetrating the mucosa; - connect the instrument with the esophagus; - squeeze both sides of the esophagus to attach a layer of esophageal wall to the stomach tissue; 30 - tighten both sides of the esophagus and the back wall of the stomach to attach a layer of esophageal wall to one or two layers of stomach tissue;

J

- introducing a tube or gastroscopic instrument into the esophagus, comprising an anvil element or a fixation release element, which is involved in fixing the esophagus to the stomach;

W - coordinate the position of the anvil element or of a fixing release element 5 inside the esophagus, in relation to said tightening instrument, around the esophagus; - suture or staple a layer of stomach tissue to a layer of esophageal tissue; - suture or staple two layers of stomach tissue to a layer of esophageal tissue; 10 - suture or staple three layers of stomach tissue to a layer of esophageal tissue; . - suture or staple four layers of stomach tissue to a layer of esophageal tissue; r - promote stapling using different stapling elements. 15 stapling depths, in different positions, in a row of stapling elements; - staple the stomach to the esophagus with a first stapling depth and staple the stomach with a second lower stapling depth; 20 - stapling a pouch with sutures connecting stomach to stomach in a row of stapling elements, also comprising stapling the esophagus with stapling elements of greater depth, included as part of said stapling line; - suture or staple one or more layers of stomach tissue in two or more 25 positions in the esophageal tissue, the esophagus having a central esophageal axis, the esophagus also having a substantially cylindrical internal and external surface that extends radially in relation to the axis esophageal tissue, and in which the stomach tissue is attached to the esophageal tissue at a first point along the first esophagus surface extension axis, substantially parallel to said central esophageal axis, and at a second point along a second esophageal surface extension axis, substantially parallel to said central esophageal axis, at a distance from said first esophageal surface extension axis, radially in relation to said central esophageal axis;

P 104/105 - release the fastening elements by means of a unit placed on said instrument; - penetrate at least one layer of the stomach tissue and one layer of the esophageal tissue with said fixing elements; - placing said fastening elements above the gastroesophageal junction, to create an elongated passage between the esophagus and the stomach, above said junction; - allow a substantially unrestricted contraction to the elongated passage and release it from the sphincter muscle that closes the cardia placed at said junction, when such an elongated passage has been created - place a part of the esophagus in the esophagus and a part of the stomach in the stomach, 10 through of an introduction into the stomach cavity; - placing the fixation element substantially between the stomach and part of the esophagus; - inserting said instrument into the main cavity of the stomach, below said junction and being adapted to direct the instrument in the cranial direction, to reach a position of said unit above said junction; - operating a joint comprised in said instrument, to enable said instrument to be inserted into the main cavity of the stomach, bending said joint in a certain direction, in order to reach a position of said part of the unit in the esophagus, above said joint.

It should be noted that any modality or part of modality, as well as any method or part of method, or any apparatus or part of apparatus, or any characteristic or part of characteristic, or any system or part of system, may be combined in one applicable manner. All examples presented here should be seen as part of the general description and, therefore, possible to combine in any of the general terms.

It should be understood that a person skilled in the art is able to combine stages, change the order of stages and combine elements of different modalities of the invention, without any inventive effort and without departing from the scope of the invention, as defined in the present description and claims attached.

It should also be noted that all the modalities or characteristics of a modality, as well as any method or stage of a method can be combined in any way, if such a combination is not clearly contradictory. Also, it should be noted that in general, the description should be seen as d describing an apparatus and a device adapted to perform a method, as well as, that method itself. 0 Although specific modalities of the invention have been described and illustrated here, it can be imagined that numerous other modalities can be desired 5 and that numerous additional advantages, modifications and changes could easily occur for those skilled in the art, without removing the spirit and scope of the invention. Therefore, the invention in its broadest aspects is not limited to specific details, representative devices and illustrated examples, as shown and described herein. Consequently, several modifications may be made without departing from the spirit and scope of the general inventive concept, as defined by the attached claims and their equivalent concepts. Therefore, and it should be understood that the attached claims are idealized to cover all these »modifications and changes, as long as they fit within the true spirit and

The scope of the invention. Numerous other modalities can be envisaged without departing from the scope and scope of the present invention.

i

Claims (206)

1. Apparatus for the treatment of obesity in a human or animal renal patient, characterized by the fact .. 5 comprise: - two or more segments of a volurne filling device, adapted to provide an implantable volume filling device, in which the volume filling device is adapted to be at least substantially sheathed by a portion of a patient's stomach wall, wherein said volume filling device is adapted to be placed with the outer surface of the device leaning against the estonian wall, 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, when the right volume filling device is sheathed on the wall of the stomach, in which said volume filling device is adapted to be disassembled in its segments of volume filling device, if the volume filling device leave its implanted and sheathed position in the stomach and inadvertently penetrate the wall of the stomach to become located inside the stomach, including penetration into the stomach wall 25 to maintain a position inside it, and it is said that said segments of the volume filling device are adapted to pass separately through the alimentary passage, of this method, reducing the risk of causing obstruction of the ileum in the patient's intestine. 30 2. Apparatus, according to claim] -, characterized by the fact that the volume filling device has a minimum perimeter of at least 15 millimeters. Apparatus according to claim 1, characterized in that the segments of the volumetric filling device have at least a part of an external surface including a biocompatible material. 5 4. Apparatus according to claim 1, characterized by the fact that the segments of the volume filling device are adapted to pass through a trocar, to install and implant said volume filling device within the abdominal cavity. 5. Apparatus according to claim 4, characterized in that the segments of the volume filling device have a flexible external shape, adapted to pass through a trocar. 6. Apparatus, according to claim 1, characterized by the fact that the segments of the volume filling device are adapted to have a shape that allows them to be installed inside said volume filling device, when it is implanted . 7. Apparatus according to claim 1, which is characterized by the fact that the segments of the volume filling device are hollow with a flexible outer surface. 8. Apparatus according to claim 7, characterized in that the segments of the volunie filling device are adapted to be filled with at least one fluid, a foam, a gel or a fluid that hardens into a solid material . 9. Apparatus according to claim 1, characterized by the fact that the segments of the volume filling device are solid. 10. Apparatus, according to claim 1, characterized by the fact that the segments of the volume filling device are adapted to provisionally maintain their installed position. Apparatus according to claim 10, characterized by the fact that the segments of the volume filling device 5 are adapted to permanently maintain their installed position, by means of the sheathed stomach wall. Apparatus according to claim 11, characterized in that the secrets of the volume filling device are adapted to be maintained in their installed position by means of an adhesive. 13. Apparatus, according to claim 1, characterized by the fact that the segments are of a certain size, which allows a free passage through the gastrointestinal system. 14. Apparatus according to claim 1, characterized by the fact that each segment is provided with at least one radio element, which sufficiently fits with at least one assembly element of another segment, thus the segments by means of fitting of mounting elements can be installed inside the inflatable volume filling device. 15. Apparatus, according to claim 14, characterized by the fact that the segments comprise a core part and a plurality of external parts. 16. Apparatus according to claim 14, characterized by the fact that the mounting element is selected from a sufficient number of flanges and slots. 17. Apparatus according to claim 15, characterized by the fact that the core part is adapted to receive and assemble the external elements within an inflatable volume filling device. '^ 18. Apparatus, according to claim 17, characterized by the fact that the core part has mounting slots adapted to receive corresponding mounting flanges from the external parts, when installing the volume filling device. 19. Apparatus, according to claim 18, characterized by the fact that the slits are distributed around the outer peripheral area of the core part. 20. Apparatus, according to any of the 10 claims 14 to 19, characterized by the fact that said at least one assembly element immobilizes each of the segments of the volume filling device to a core part along a period. first plane, and in which the segments of the volurne filling device and the core part still comprise second elements of assembly, which after the assembly of said segments and part of core will immobilize each segment and part of the core along üIR second plane, with a certain angle in relation to said foreground. 21. Apparatus according to any of claims 1 to 20, characterized by the fact that the apparatus further comprises a guide device, operable for mounting the segments of the volume filling device in an infinitely variable volume filling device. 22. Apparatus, according to claim 20, characterized by the fact that c) guide device is an operating wire, operably connected to the segments. 23. Apparatus, according to claim 21, 30, is cared for by the fact that the operating wire is made of a material that is biodegradable when in contact with the body fluid in the abdominal cavity, in order to allow the disassembly of the device filling of volume ltlt its seconds. 24. Apparatus according to claim 23, characterized by the fact that an operating wire is connected to a part of the core and to the external parts, so that the external parts can be sequentially mounted on the part of the core, from this mode, providing "volume filling device assembly. 25. Apparatus according to claim 24, characterized by the fact that the operating wire is connected to the external mounting flanges. 10 26. Apparatus according to claim 25, characterized by the fact that the core part is provided with at least one operating channel for receiving the operating wire. 27. Apa.relho, according to claim 26, 15 characterized by the fact that each external part is connected to two operating channels by said "operation wire. 28. Apparatus according to claim 27, characterized by the fact that a first operating channel has a first hole in the end surface of the core part and a second hole in a first slot of the core part, so that when if the operating wire received in said first operating channel is moved in a direction of said end surface, a first outer part is mounted to said core part. 29. Apparatus according to claim 28, characterized in that a second operating channel has two holes in a second slot in the core part, so that when the operating wire 30 connected to the first operating channel is moved , in a direction of said end surface, a second outer part is mounted to said core part. 30. Apparatus, according to claim 29, characterized by the fact that it has three or more external parts mounted in projected slots of the núcj-eo part, with c) operation wire through operating channels having holes in each projected slot of the said core part. 31. Apparatus according to claim 29, characterized by the fact that the operating wire projects from the first channel hole, so that it can be operated with an instrument to displace said operating wire and a first element external, so that its mounting flange fits with its first projected mounting slot in the core element, and in a predetermined sequence, in the same groove, displacing the remaining external elements, in order to provide the assembly of the filling device. intactable volurne. 32. Apparatus according to claim 1, characterized in that it comprises ends of three segments of volume filling device. 33. Apparatus according to claim 1, characterized in that the volume filling device has a maximum circumference of at least 30 meters. 34. Apparatus according to claim 1, characterized by the fact that at least part of the volume filling device is inflatable or expandable to an expanded state, and in which one or more of the segments of the volume filling device are inflatable or expandable to an expanded state. 35. Apparatus according to claim 34, characterized by the fact that at least one of the segments of the volume filling device has a port for a fluid or gel, being adapted to be connected to a gastroscopic instrument. 36. Apparatus according to claim 35, characterized by the fact that the entrance door comprises a fluid connection, adapted to interconnect the inflatable device and the gastroscopic instrument. 37. Apparatus according to claim 1, characterized in that the volume filling device 5 and / or one or more of the two hundred volume filling devices have an elongated shape. 38. Apparatus according to claim 37, characterized in that the volume filling device and / or one or more of the segments of the volume filling device have a rounded format. 39. Apparatus according to claim 38, characterized by the fact that the volume filling device has a folded or curved shape. 40. Apparatus according to claim 1, characterized by the fact that one or more of the segments of the volume filling device comprise an elastic material. 41. Apparatus according to claim 1, characterized in that at least a part of the volume filling device comprises a bioccumpatible material. 42. Apparatus according to claim 1, characterized in that at least a part of the volume filling device and one or more of the segments of the volume filling device comprise silicone. 43. Apparatus according to claim 1, characterized by the fact that at least a part of the volume filling device and one or more of the segments of the volume filling device are provided with at least one layer. 44. Apparatus according to claim 43, characterized by the fact that said at least one layer is a Parylene® layer. 45. Apparatus according to claim 43, characterized by the fact that said at least one layer is a high layer of polytetrafluoroethylene. 46. Apparatus, according to claim 43, 5 is expensive due to the fact that said at least one layer is a polyurethane layer. 47. Apparatus, according to claim 43, characterized by the fact that said at least one layer comprises a silicon strip. 48. The apparatus according to claim 43 is retained by the fact that said at least one layer comprises a layer of metal. 49. Apparatus according to claim 1, characterized in that at least one of the segments of the volume filling device comprises a fluid. 50. Apparatus according to claim 49, characterized by the fact that the fluid is adapted to be transformed into a solid state or in a fixed form. 51. Apparatus according to claim 49, characterized in that the fluid is liquid polyurethane. 52. Apparatus, according to claim 49, characterized by the fact that the fluid is isotonic. 53. Apparatus according to claim 49, characterized by the fact that the fluid comprises large molecules to prevent diffusion. 54. Apparatus according to claim 49, characterized in that q fluid comprises iodine molecules. 55. Apparatus, according to claim 1, is fixed by the fact that at least 1 aiii of the segments of the volurne filling device comprise a homogeneous material. 56. Apparatus according to claim 1, characterized by the fact that at least one of the segments of the volume filling device is a solid body. 57. Apparatus according to claim 1, 5 characterized by the fact that at least one of the segments of the volume filling device comprises a containment wall defining a chamber .. 58. Apparatus according to claim 1, characterized by the fact that at least one of the secrets of the volume filling device comprises a rigid external surface. 59. Apparatus, according to claim 1, characterized by the fact that at least one of the segments of the volume filling device comprises an external, elastic surface. 60. Apparatus according to claim 1, characterized by the fact that at least one of the segments of the volume filling device comprises a flexible external surface. 61. Apparatus according to claim 33, characterized by the fact that the volume filling device has a minimum circumference of at least 30 millimeters. 62. Apparatus according to claim 61, characterized in that the volume filling device has a circumference of at least 80 millimeters. 63. Apparatus according to claim 1, characterized by the fact that the volume filling device has a volume between 0.00001 and 0.001 m3. 64. Apparatus according to claim 63, characterized by the fact that the volume filling device has a volume between 0.00001 and 0.0002 ui3. 65. Apparatus, according to claim 33, characterized by the fact that the segments of the volume filling device are deformable in a maximum diameter, so as to be inserted into a laparoscopic trocar. 66. Apparatus according to claim 33, characterized in that the segments of the volume filling device are adapted to be held in place by means of sutures with stomach-to-stomach connection clamps, to sheathe the device on the wall of the stomach, when implanted and installed. 67. Apparatus according to claim 66, characterized by the fact that the sutures or staples connecting the sternum to the sternum are provided with fixation portions that exhibit a structure adapted to be in contact with the stomach wall, from inode to proniover the growth of a human tissue, to hold for long term the placement of the volume filling device fixed to the stomach wall. 68. Apparatus according to claim 67, characterized by the fact that the structure comprises a network-like structure. 69. Apparatus according to claim 1, characterized by the fact that the volumetric filling device is adapted to be adjustable in a non-invasive manner after operation. 70. Apparatus, according to claim 33, characterized by the fact that the volume filling device has a variable perimeter, in order to be better adapted to be kept in place, sheathed in the patient's stomach wall. 71. Apparatus, according to claim 1, characterized by the fact that it comprises a stretching device placed outside the stomach wall and adapted to stretch a part of said stomach wall, thereby affecting the patient's appetite, the apparatus comprising yet a fluid connection that connects the stretching device and the 5 volume filling device. 72. Apparatus according to claim 71, characterized by the fact that the volume filling device is adapted to be placed outside the stomach wall by means of a gastroscopic instrument. 73. Apparatus according to claim 71, characterized by the fact that the volurne filling device and the stretching device, as at least two interconnectable portions of the apparatus, are adapted to be placed outside the stomach wall, as portions separate. 74. Apparatus, according to claim 1, is fixed by the fact that at least one part of the volume filling device comprises one. outer surface layer of polyurethane, Teflon®, or PTFE, or a combination of the layers. 75. Apparatus, according to claim 1, aeroeterized by the fact that the segments of the volume filling device can be destroyed by acid, preferably by hydrochloric acid. 76. Apparatus according to claim 1, characterized in that at least a part of the volume filling device comprises a gel. 77. Apparatus, according to claim 76, characterized by the fact that the gel has a Shore hardness value of less than 15. 78. Apparatus according to claim 1, characterized by the fact that the segments of the volumetric filling device comprise a fixing device to cooperate with a tightening tool. 79. Apparatus according to claim 1, characterized by the fact that the volume filling device is adapted to be completely sheathed by the patient's stomach wall. 5 80. Apparatus according to claim 1, characterized in that it comprises a fixing device, adapted to fix the volume filling device or segments of the rhythm to the stomach wall, in order to maintain the volume filling device in place, when said volurne filling device is implanted. 81. Apparatus, according to claim 63, characterized by the fact that the volume filling device has a volume uri less than 0.0002 ni3. 82. Apparatus, according to claim 63, made more expensive by the fact that the volume filling device has a volume between 0.0001 and 0.001 in3. 83. Apparatus according to claim 1, characterized in that at least a part of the volume filling device is made of a material that is not acid-destructible. 84. Apparatus according to claim 61, characterized by the fact that the volume filling device has a perimeter of at least 70 µm. 85. Apparatus according to claim 61, characterized by the fact that the volume filling device has a perimeter of at least 1110 μm. 86. Apparatus according to claim 61, characterized by the fact that the volume filling device has a perimeter of at least 160 mm. 87. Apparatus according to claim 61, characterized by the fact that the volume filling device has a perimeter of at least 220 mm. 88. Apparatus according to claim 1, e = altered by the fact that at least one of the segments of the volume filling device comprises a flexible non-elastic material. 5 89. Apparatus, according to claim 1, characterized by the fact that it also comprises a fixation device, adapted to participate in fixing the volume filling device to the stomach wall. 90. Apparatus according to claim 1, characterized by the fact that it also comprises two or more fixation devices, adapted to participate in fixing the volume filling device to the stomach wall. 91. Apparatus according to claim 1, characterized by the fact that the volume filling device including at least one of the volume filling device segments comprises a holding device, adapted to be maintained by an instrument and to simplify device deployment. 92. Apparatus according to claim 91, characterized by the fact that the volume filling device comprises two or more holding devices, adapted to be maintained by an instrument and to simplify the implantation of the device. 93. Apparatus, according to claim 1, characterized by the fact that at least one of the segments of the volume filling device comprises an inflatable chamber, also comprising at least one tube connected to the device, for supplying fluid to the chamber. 94. Apparatus, according to claim 93, characterized by the fact that it also includes an injection port that can be connected to the tube. 95. Apparatus according to claim 1, 5 characterized by the fact that the volume filling device has a maximum perimeter, when viewed in a plane perpendicular to an axis of the device, and in which the perimeters of the device, when viewed on other planes perpendicular to said axis, they are equal to the maximum perimeter or smaller, when viewed along said axis, in the direction of the maximum perimeter. 96. Apparatus according to claim 1, characterized in that the perimeter of the volume filling device, when viewed in a plane perpendicular to an axis of the device, increases and decreases' at least twice, when the plane is displaced along said axis, or decreases and at the same time at least once, when the plane is displaced along said axis. 97. Apparatus according to claim 48, made more expensive by the fact that the metal layer comprises a metal selected from gold, silver and titanium, or a co-combination thereof. 98. Apparatus, according to claim 43, characterized by the fact that at least a layer comprises a layer of Teflon®. 99. Apparatus according to claim 43, characterized in that the volume filling device is provided with a plurality of layers. 100. Apparatus according to claim 99, characterized by the fact that the volume filling device comprises an outer surface layer of polyurethane, Teflon®, polytetrafluoroethylene, Farylene®, silicone, inetal, or a combination thereof. 101. Apparatus for the treatment of obesity, according to claim 1, characterized by the fact that the volume filling device comprises at least one operable stretching device, implantable 5 in an obese patient and adapted to stretch a portion of the patient's wall. patient's stomach; and an operating device for operating the stretching device when implanted, to stretch the stomach wall portion, so that a feeling of satiety is created. 102. Apparatus for treating obesity according to claim 101, characterized by the fact that the volume filling device comprises an implantable control unit, to automatically control the operable stretching device when the control unit and the stretches are implanted to stretch the portion of the stomach wall, correlated with the patient's diet, so that a feeling of satiety is created. 103. Apparatus for treating obesity, according to claim 101, characterized by the fact that said stretching device comprises an expandable stretching reservoir, in which the volume filling device is inflatable and is in fluid communication with the patient. said stretching reservoir, wherein said operating device comprises a pump for pumping fluid between said main reservoir and said stretching reservoir, to stretch said stomach wall portion. 104. Apparatus for treating obesity, according to claim 103, characterized in that it comprises a control device, for controlling said stretching device, including said pump. 105. Apparatus for treating obesity according to claim 104, characterized by the fact that said control device comprises a wireless remote control device, adapted to control the stretching device from outside the patient's body. 106. Apparatus for treating obesity, according to claim 104, characterized in that said control device comprises a switch or reservoir placed subcutaneously, adapted to control c) stretching device outside the patient's body. 107. Apparatus for treating obesity, according to claim 104, characterized by the fact that said control device comprises an implantable control unit to control said stretching device. 108. Device according to claim 107, comprising a sensor or detection device, adapted to be implanted in the body of a patient, characterized by the fact that the implantable control-e unit is adapted to control the stretching device. inside the patient's body using information from said sensor or detection device, adapted to detect, directly or indirectly, the patient's food intake. 109. Apparatus for treating obesity, according to claim 1, characterized in that the volume filling device comprises a main volume filling reservoir and, at least, an operable stretching device, implantable in a obese patient and adapted to stretch a portion of the patient's stomach wall, wherein said stretching device comprises an expandable reservoir, adapted to be sheathed in the stomach wall, in the upper part of the stomach, above the inflatable main volume filling device, when the patient is standing, in which the volume 5 filling device is inflatable and co-communicating fluid with said stretching reservoir, since normal contractions of the stomach wall correlated with food intake require the fluid to circulate from said sheathed main volume filling reservoir, placed lower in the stomach wall, adapted to compel the said stretching reservoir to stretch said portion of the stomach wall, so that a feeling of satiety is created. 110. Apparatus for treating obesity, according to claim 109, characterized by the fact that the fluid connection between the main volume filling device reservoir and the stretching reservoir comprises a back pressure valve. 111. Apparatus for treating obesity, according to claim 109, characterized by the fact that the fluid connection between the main volume filling device reservoir and the stretching reservoir comprises a release function adapted to liberate the volume of the reservoir of stretch stretch to the reservoir of the main volume filling device. 112. Apparatus for treating obesity according to claim 109, characterized in that said release function comprises a fluid return connection of a substantially smaller area than said fluid connection, to slowly return fluid to said reservoir of the main volurne filling device, coming from said stretching reservoir, to release c) said stretching of the stomach wall portion. 113. Apparatus for treating obesity, according to claim 109, characterized by the fact that it comprises a manual control device, which comprises a reservoir placed subcutaneously, adapted to control the stretching device from outside the patient's body, to affect furthermore the stretching device, to stretch the stomach wall portion. 114. Apparatus according to claim 1, characterized by the fact that the volume filling device comprises a main volume filling device reservoir, adapted to be inflatable, the apparatus further comprising an expandable structure, adapted to expand when the device is sheathed in the stomach wall, in which said structure comprises a bellows-like element, adapted to take into account the fibrosis that surrounds the device when implanted, so that the movement of the bellows-like element is not substantially affected by said fibrosis. 115. Obesity treatment apparatus according to claim 1, characterized in that the volume filling device comprises at least one operable stretch device, implantable in an obese patient and adapted to stretch a portion of the wall stomach of a patient, and in which the stretching device comprises an expandable structure, adapted to expand and stretch the stomach wall portion, when the volume filling device is being sheathed in the stomach wall, in which said structure comprises a special fol-like element, adapted to take into account the fibrosis that surrounds the device when implanted, so that the movement of the bellows-like element is not substantially affected by said fibrosis. 116. Apparatus for treating obesity according to claim 115, characterized by the fact that it comprises an operating device to operate the stretching device when implanted, to stretch the wall portion of the stomach, so that a sensation of satiety. 117. Obesity treatment apparatus according to claim 115, characterized by the fact that the volume filling device comprises an implantable control unit to autonomously control the operable stretching device when the control unit and the stretching device is implanted, to stretch the portion of the stomach wall, in correlation with the patient's food, so that a feeling of satiety is created. 118. Apparatus for treating obesity, according to claim 1, characterized by the fact that the voluine filling device comprises a stretching device, which comprises at least one operable stretching device, implantable in an obese patient , and adapted to stretch a portion of the wall of a patient's stomach, so that a feeling of satiety is created. 119. Apparatus for treating obesity according to claim 118, characterized in that said control device comprises a wireless remote control device, adapted to control the stretching device from outside the patient's body. 120. Apparatus for treating obesity according to claim 118, characterized in that said control device comprises a switch or reservoir placed subcutaneously, adapted to control the stretching device from outside the patient's body. 121. Apparatus for treating obesity according to claim 118, characterized by the fact that said control device comprises an implantable control unit, to control said stretching device. 122. Device according to claim 121, comprising ükl sensor or detection device, adapted to be implanted in a patient's body, and fixed by the fact that the implantable control unit is adapted to control the stretching device from within the patient's body using information from said sensor or detection device, adapted to detect, directly or indirectly, the ingestion of the patient's food. 123. Apparatus for treating obesity according to claim 1, characterized in that the volume filling device further comprises a stretching device, which comprises three or more mechanical parts connected with different parts of the stomach wall, wherein each connected part includes suturing or stapling with the stomach wall, or sheathing the mechanical parts in the stomach wall part with stomach-to-stomach connecting sutures, where the three or more mechanical parts are adapted to move relatively to each other and adapted to stretch three different wall portions, the stretching device being further adapted to have said wall portions stretched independently of each other, in relation to the force used to stretch the stomach wall portion, as well as the periods of time when the stretch is applied and when the stretch is applied. 124. Apparatus for treating obesity, according to claim 1, characterized by the fact that the volume filling device further comprises a stretching device, c) which comprises two or more hydraulic parts connected with different parts of the stomach wall , êHL that each. said connected part includes suturing or stapling of the hydraulic part to the stomach wall, or the elnbairing of the hydraulic parts in the stomach portion of the stomach with stomach-to-stomach sutures. relatively to each other, and adapted to stretch three different wall portions, the stretching device being further adapted to have said wall portions stretched independently of each other, in relation to the force used to stretch the stomach wall portion, as well as, the time periods when the stretch is applied and when the stretch is applied. 125. Apparatus for treating obesity, according to claim 1, characterized in that the volume filling device further comprises a stretching device, which is connected with a part of the stomach wall, including suturing or stapling the stretching device to the stomach wall, or the hemming of the stretching device to the stomach wall portion with stomach-to-stomach connecting sutures, whereas the stretching device is further adapted to stretch a portion of the stomach wall, controlling the force used to stretch the wall portion of the stomach, as well as the periods of time when the stretch is applied and when the stretch is applied. 126. Apparatus for treating obesity, according to claim 1, expensive due to the fact that - that the volume filling device comprises a stretching device, which comprises two parts connected with different parts of the stomach wall, each said connected part including suturing or stapling of the parts with the stomach wall , or sheathing the parts in the stomach wall portion with sternal to sternal connection sutures, in which the stretching device is further adapted to have different portions of wall stretched independently of each other, controlling the force used to stretch the portion of stomach wall, as well as the periods of time when the stretch is applied and when the stretch is applied. 127. Apparatus for treating obesity, according to claim 1, characterized by the fact that the volume filling device also includes an external control unit, to control the volume filling device from outside the patient's body. 20 128. Device, according to. claim 127, characterized by the fact that the external control unit comprises a wireless remote control device, adapted to control the device from outside the patient's body. 129. Device according to claim 127, characterized in that the external control unit comprises a switch or reservoir placed subcutaneously, adapted to control the device from outside the patient's body. 130. Apparatus for treating obesity according to claim 1, characterized by the fact that the volume filling device comprises a sensor or detection device, adapted to be implanted in a patient's body, even though the The implantable control is adapted to control the device from within the patient's body using information from said sensor or detection device, adapted to detect, directly or indirectly, the patient's food intake. 131. Apparatus for treating obesity according to claim 1, characterized in that the voluine filling device is adapted to be at least substantially sheathed by a portion 10 of a patient's stomach wall, having an external surface including a biocompatible material, and where the volume filling device is adapted to be placed inside the stomach, with the outer surface of the volume filling device leaning against the inside of the stomach wall, so that the volume of the aluminum cavity is reduced in size by a volume that exceeds the volume of the volume filling device, which has a maximum circumference of at least 30 millimeters. 20 132. Apparatus according to claim 131, characterized by the fact that the volurne filling device is adapted to be placed inside the stomach, using a gastroscopic instrument. 133. Obesity treatment apparatus according to claim 1, characterized by the fact that the volume filling device is adapted to be at least substantially sheathed by "a portion of a patient's stomach wall, having a surface outer layer of a biocoinpatible material, and the volume filling device is adapted to be placed outside the stomach wall, with the outer surface of the volume filling device resting against the outside of the stomach wall, so that the volume of the feed cavity is reduced in size by a volume that substantially exceeds the volume of the volume filling device, the volume filling device having a maximum perimeter of at least 30 millimeters. 134. Apparatus according to claim 1, characterized by the fact that it comprises an adjustment device for adjusting the size and / or shape of the volume filling device and at least one of its segments. 135. Apparatus according to claim 134, characterized by the fact that the size of the volume filling device is hydraulically adjustable and the adjustment device comprises a reservoir of hydraulic fluid, which when implanted in a patient is connected to at least one of the segments of the volume filling device, and eni that the size of the volume filling device is regulated in a non-invasive way by moving the hydraulic fluid from the reservoir to said at least one of the segments of the volume filling device. volume filling, thereby adjusting the size of said at least one segment of the volume filling device. 136. Apparatus according to claim 135, characterized in that it also comprises a hydraulic adjustment device, which comprises at least one chamber which, when implanted in the patient, is sheathed in the patient's stomach wall with the volume filling device and connected to said volume filling device, and in which the amount of hydraulic fluid contained in at least one of the segments of the volume filling device is regulated in a non-invasive manner, with a fluid distribution between the hydraulic reservoir and said at least one camera. 137. Apparatus according to claim 136, characterized by the fact that said at least one chamber when implanted in the patient is filled with hydraulic fluid, using a pump in the reservoir, in order to stretch the bottom wall of the stomach and create a feeling of satiety in the patient. 138. Apparatus, according to claim 134, expensive due to the fact that the adjustment device further comprises a servo-reverse mechanism, which comprises three adjustable reservoirs with hydraulic fluid, in which a small volume of fluid in a first reservoir placed subcutaneously, which is part of a first closed system that includes a second reservoir, is compressed with a high force- per unit area, to move a small volume of hydraulic fluid, and in which the second reservoir affects a greater volume of hydraulic fluid in a third reservoir, the third reservoir forming part of a second closed system having a greater volume than said first reservoir, thereby creating a movement of a greater total volume of hydraulic fluid, with less force per unit area. 139. Apparatus according to claim 134, characterized by the fact that it also comprises a wireless remote control device, in which the volume filling device when implanted in a patient is regulated by a non-invasive device by the control device renioto without wire. 140. Apparatus, according to claim 134, characterized by the fact that it also comprises an energy source, which activates the adjustable volume filling device, when implanted in the patient. 141. Apparatus according to claim 140, characterized by the fact that the energy source comprises an internal source of energy implantable in the patient. 142. Apparatus, according to claim 140, characterized by the fact that the source of energy comprises an external source of energy that transmits energy wirelessly. 143. Apparatus, according to claim 142, characterized by the fact that it also comprises an internal irrigable energy source in the patient, which when implanted in the patient can be charged by the wireless energy transmitted by the external energy source. 144. Apparatus according to claim 139, characterized by the fact that the wireless remote control device comprises at least one external signal transmitter and receiver, further comprising an internal implantable signal transmitter and receiver in the patient, for receiving the signals transmitted by the external signal transducer and sending the feedback signals back to the remote control device. 145. Apparatus according to claim 139, characterized by the fact that the wireless control signal comprises an electric or wagnetic field, or a combination of electric and magnetic fields. 146. Apparatus, according to claims 1 or 134, characterized by the fact that it also includes a wireless energy transmitter, for energizing in a non-invasive way, any part of the apparatus that is in need of supplementation. 147. Apparatus according to claim 146, characterized by the fact that the energy transmitter transmits energy by means of at least one wireless energy signal. 148. Apparatus according to claim 147, made more expensive by the fact that the wireless energy comprises a signal or a wave field. 149. Apparatus according to claim 148, 5 characterized by the fact that the wave signal is selected from the group consisting of: a sound wave signal, an ultrasonic wave signal, an electromagnetic wave signal, uin . infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal, a radio wave signal, an X-ray radiation signal, and a gamma radiation signal. 150. Apparatus according to claim 148, characterized in that the wireless energy signal comprises an electric field or a magnetic field, or a combination of an electric and magnetic field. 151. Apparatus, according to claim 148, characterized by the fact that it also comprises an implantable accumulator and an energy transformation device, which transforms wireless energy into electrical energy, in which electrical energy is used, by partially rhyenes, to charge the accumulator. 152. Apparatus according to claim 1 or 134, characterized by the fact that it further comprises a sensor that detects a parameter. 153. Apparatus according to claim 152, characterized by the fact that the parameter is a functional parameter. 154. Apparatus according to claim 153, characterized by the fact that the functional parameter is correlated to a wireless energy transfer, for charging an internal implantable energy source in the patient. 155. Apparatus, according to claims 153 or 154, characterized by the fact that it still comprises a feedback device, which, when implanted in the patient, sends feedback information from inside the patient's body out of the unknown, the information of realirnentation being correlated to the functional parameter. 156. Apparatus according to claim 153, characterized in that it also comprises an internal implantable control unit for controlling a volume filling device in response to the sensor that detects the functional parameter. 157. Apparatus according to claim 152, characterized by the fact that the parameter is a physical parameter of the patient. 158. Apparatus according to claim 157, characterized by the fact that the sensor for detecting the physical parameter is a pressure sensor. 159. Apparatus according to claim 157, characterized by the fact that the sensor for detecting the physical parameter is a motion sensor, 160. Apparatus according to claim 157, characterized by the fact that it also comprises an internal implantable control unit, for controlling the volume filling device in response to the sensor that detects the physical parameter. 161. Apparatus, according to claims 1 or 134, characterized by the fact that it also comprises an operating device for operating the volume filling device, in order to control its size and / or shape. 162. Apparatus according to claim 161, characterized by the fact that the operating device comprises a motor or a pump. 163. Apparatus according to claim 1 or 134, characterized by the fact that the volume filling device is further adapted to receive wireless energy, in which the wireless energy is used to drive the operating device, to generate kinetic energy for the operation of the volume filling device. 164. Apparatus, according to claim 163, characterized by the fact that senile wire is used to directly drive the operating device, so as to create kinetic energy for the operation of the volume filling device, when the energy without wire is being transmitted by the energy transfer device. 165. Apparatus according to claim 163, characterized in that the wireless energy comprises a wave signal selected from the group consisting of: a sound wave signal, an ultrasonic wave signal, a wave signal electrornagnetic, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal, a radio wave signal, an X-ray radiation signal, and a radio signal. gamma radiation. 166. Apparatus, d, and according to claim 163, characterized in that the wireless energy signal comprises an electric field or üIIL magnetic field, or a combination of electric and magnetic field. 167. Apparatus, according to claims 1 or 134, characterized by the fact that it also includes irnplantable electrical components, including at least one voltage level protector. 168. Apparatus according to claim 1 or 134, characterized in that it also comprises implantable electrical components, including at least a constant current protector. 169. The device, according to claim 164, is more expensive due to the fact that it also includes an energy transformation device, for transforming energy without Ilium into ejectric energy, in which electrical energy is used to directly activate the operating device, so as to create kinetic energy for the operation of the volume filling device, when wireless energy is being transmitted by the energy transmission device. 170. Apparatus, according to claim 1, characterized by the fact that the volume filling device has a perimeter, as seen in a plane perpendicular to an axis of the body, and eni that the perimeter constantly increases or remains constant when it moves along said axis, from a first extreme point of the axis to an intermediate point with a point of maximum, and in which the perimeter constantly decreases or remains constant, when it moves from said intermediate point to a second extreme point of said axis. 171. Apparatus, according to claim 1, characterized by the fact that the volume filling device has a perimeter, as seen in a plane perpendicular to an axis of the body, whereby the constant perimeter increases or remains constant when moving along said axis, from a first outer point of said axis to a first intermediate point with a first maximum point, and the perimeter constantly decreases or remains constant when moving from said first intermediate point to a second intermediate point with a first minimum point, and then the constant perimeter increases or remains constant when moving along said axis, from said second intermediate point of said axis to a third intermediate point with a second max point, and still in that the perimeter constantly decreases or remains constant, when moving from said third intermediate point building for a second extruded point of said axis. 172. Apparatus according to claim 20, characterized by the fact that the first plane and the second plane are substantially perpendicular. 173. Apparatus according to claim 172, characterized by the fact that the second mounting elements are leveling elements, with corresponding projections and recesses, provided in the segments of the volume filling device and in the core part. 174. Apparatus, according to claim 173, characterized by the fact that at least one mounting element further comprises projections and recesses. 175. Apparatus according to claim 174, characterized by the fact that at least one mounting element comprises a mounting slot in the core part and a mounting flange in a segment, and in which a mounting element leveling comprises a projection in said slot and a recess in said flange; or wherein said at least one mounting element comprises a mounting flange on the core part and a mounting slot in a segment, and wherein said leveling element comprises a projection in said slot and a recess on said flange. 176. Apparatus according to claim 99 characterized by the fact that the volume filling device comprises an inner surface layer of polyurethane, Teflon®, polytetrafluoroethylene, Parylene®, silicone, metal, or a combination thereof. 177. Apparatus according to claim 99, characterized in that the volume filling device comprises an inner surface layer of polytetrafluoroethylene and an external silicon layer. 178. Apparatus according to claim 99, which is characterized by the fact that the volume filling device comprises an inner surface layer of polytetrafluoroethylene, an intermediate silicone layer and an outer layer of Parylene®. 179. Apparatus according to claim 99, characterized by the fact that the volume filling device comprises an inner surface layer of polyurethane and an outer layer of silicone. 180. Apparatus according to claim 99, characterized in that the volume filling device comprises an inner surface layer of polyurethane, an intermediate silicone layer and an outer layer of Parylene®. 181. Apparatus, according to claim 43, characterized by the fact that the volume filling device comprises an outer layer that includes a biocompatible material. 182. Apparatus according to claim 1, which is characterized by the fact that at least one of the segments of the volume filling device has the shape of a polyhedron. 183. Apparatus, according to claim 182, characterized by the fact that at least üIIl of the segments of the volume filling device presents LlIll of the following formats: tetrahedron, hexahedron, octahedron, dodecahedron, and icosahedron. 184. Apparatus according to claim 1, characterized by the fact that it comprises a friction-increasing material. 185. Apparatus, according to claim 184, is characterized by the fact that the friction increase material is any of the following materials: a glue and an adhesive. 186. Apparatus according to claim 1, characterized in that at least one of the segments of the volume filling device has a surface with a rough texture. 187. Apparatus according to claim 1, characterized by the fact that it comprises a friction-reducing material on the external surface of the volume filling device segments. 188. Apparatus according to claim 187, characterized by the fact that the friction reduction material is a fluid that reduces friction between adjacent segments of the volume filling device. 189. Apparatus according to claim 1, characterized in that it comprises a second expandable segment of the volume filling device, to include two or more first segments of the volume filling device, different from the second segment of the volume filling device. volurne, wherein the second segment of the volume filling device and the first segments of the volume filling device together form said volume filling device. 190. Apparatus according to claim 189, characterized in that said second segment of the volume filling device comprises a friction reducing material on its internal surface, the friction reducing material being available in contact with the first segments of the volume filling device, when it is implanted. 191. Apparatus according to claim 189, characterized in that said second segment of the volume filling device is adapted to be filled with a fluid, to allow a mutual movement between the first adjacent secrets of the volume filling device. volume, so that the shape of the volume filling device is adapted to the movements of the stomach wall when the right volume filling device is sheathed in a stomach wall. 192. Apparatus according to claim 189, characterized in that at least a wall portion of said second segment of the volume filling device is flexible. 193. Apparatus according to claim 189, characterized in that at least a wall portion of said second segment of the volume filling device is stretchable. 194. Apparatus, according to claim 191, characterized by the fact that said fluid is isotonic or hypertonic. 195. Apparatus according to any of claims 1-194, characterized by the fact that the segments of the volume filling device are adapted for insertion into a pouch, formed by a part of the patient's stomach wall. 196. Apparatus, according to claim 1, characterized by the fact that said segments of the volume filling device are adapted for filling, directly or indirectly, inside the bag formed by a part of the patient's stomach wall, through a tubular instrument. 197. Apparatus according to claims 195 or 196, which has been cured by the fact that the volume filling device comprises a solidifying liquid. 198. Apparatus according to claim 197, characterized by the fact that said apparatus comprises a conduit adapted to release said fluid which solidifies within said pouch, through said conduit. 199. Apparatus, according to claim 1, characterized by the fact that said plurality of volume filling device features are adapted to be interconnected, so as to form the volume filling device, after said plurality of segments of the volume filling device be inserted into a human or artificial bag. 200. Apparatus according to claim 1, characterized by the fact that at least one of the segments of the volume filling device has a spherical shape. 201. Apparatus according to claim I, characterized by the fact that at least one of the segments of the volume filling device has a flat surface. 202. Apparatus, according to claim 1, characterized by the fact that the segments of the volume filling device are adapted to be mounted in an implantable volume filling device. 203. Apparatus according to claim 1, characterized by the fact that the segments of the volume filling device are adapted to form an implantable volume filling device of a controlled size. 204. Method, using an apparatus according to any of claims 1-203, characterized in that said method comprises one or more of the following operational steps: - introducing an instrument into the throat; - descend the instrument into the esophagus; - place an anvil or a unit to release fixation elements in the esophagus, between the cardia and the level of the diaphragm, to connect with the fixation of the esophagus to the stomach tissue; - lower the instrument further in the esophagus and later still more inside the stomach; - fill the stomach with gas to expand the mesinum; - suck fluid from the stomach; - observe an urgent guide-visualization when said instrumentalist catches a camera; - connect the instrument with the stomach; - create and suture at least one pouch from the stomach wall; - fill said container with a fluid ülü bag and / or a volume filling device, or two or more volume filling devices; - releasing a plurality of volume filling devices within said pouch created in the stomach tissue, through a tubular element; - pass through the stomach wall, into the stomach, with said instrument; - pass through the wall of the stomach with said instrument, for placement of a volume filling device outside the stomach wall; - pass through the stomach wall with said instrument, for placement of a tube that allows the placement of a subcutaneous injection port; - place a subcutaneous injection port; - suture or staple the stomach wall, from the inside to the esophagus; - suture or staple the stomach wall connection to the stomach wall, from the inside of the stomach; - connect the instrument with the esophagus; - suture or staple a layer of stomach tissue to a layer of esophageal tissue; - suture or staple 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; - suture or staple four layers of stomach tissue to a layer of esophageal tissue; - suture or staple one or more cainates of the stomach tissue to two or more positions in the esophageal tissue, the esophagus having a central esophageal axis, the esophagus also having a substantially cylindrical internal and external surface that extends radially in relation to the axis esophageal tissue, and in which the stomach tissue is attached to the esophageal tissue at a first point along a first axis of esophageal surface extension, substantially parallel to said central esophageal axis, and a second point along a second axis of esophageal surface tension, substantially parallel to said central esophageal axis, at a distance from said first esophageal surface extension axis, radially in relation to said central axis of the esophagus; - release the fastening elements by means of a unit placed on said instrument; - penetrate at least one layer of the stomach tissue and one layer of the esophageal tissue with the fixation elements; - placing said fastening elements of the gastroesophageal junction, to create an elongated passage between the esophagus and the stomach, above said junction; - place a part of the esophagus in the esophagus and a part of the stomach in the stomach; - placing the fixation element substantially between the stomach and the esophageal part; - insert said instrument into the main cavity of the stomach through the cardia, adapted to direct the instrument in the cranial direction, to reach a position of said unit above said junction; - allow a substantially unrestricted contraction to the elongated passage and release it from the sphincter muscle that closes the cardia placed in said junction, when such an elongated passage has been created. 205. Method of using an apparatus according to any of claims 1-203, characterized by the fact that said method comprises one or more of the following operational steps: - cutting a patient's skin; - create an opening in the patient's abdominal wall; - introducing said instrument into the abdominal cavity, through said opening in the abdominal wall; - connect the instrument with c) stomach; - press down on the instrument inside the stomach wall, in order to create at least one pre-molded bag for the wall of the stomach; - grainpear the stomach wall, in order to create, at least, a pre-molded stomach wall pouch; - suture or staple at least a pouch on the stomach wall; - filling said fluid into the COK1 pouch with a fluid and / or a volume filling device, or two or more volume filling devices; - releasing a plurality of volume filling devices into said pouch created in the stomach tissue, through a tubular element; - pass through the stomach wall, inside the stomach, with said instrument; - - pass through the stomach wall with said instrument, for placement of a filling device 5 volume inside the stomach wall; - pass through the stomach wall with the right instrument, to suture the stomach wall to the esophageal wall; - placing a volume filling device 10 outside the wall of the estuary; - sheathing said volume filling device against the stomach wall; - place a subcutaneous injection port; - suture or staple the stomach wall with the stomach wall outside the stomach; - suture or grainpear the stomach wall with the stomach wall outside the stomach without penetrating the mucosa; - suture or group two layers of the stomach wall to one or two layers of the stomach wall; 20 - connect the instrument to the esophagus; - squeeze both sides of the esophagus to fix a layer of esophageal wall to the stomach tissue; - tighten both sides of the esophagus and the back wall of the stomach, to attach a layer of esophageal wall to 25 or two layers of tissue in the stomach; - inserting a gastroscopic tube or instrument into the esophagus, comprising an anvil element or a fixation release element, which involves the fixation of the esophagus to the stomach; 30 - coordinate the position of the anvil element or a fixation release element within the esophagus in relation to said tightening instrument, around the esophagus; - suturing or stapling a piece of stomach tissue to a layer of esophageal tissue; - suture or staple two layers of stomach tissue to a layer of esophageal tissue; © * "suture or staple three layers of stomach tissue to a line of esophageal tissue; 5 - suture or staple four layers of stomach tissue to a layer of esophageal tissue; - promote stapling using stapling elements of different stapling depths, in different positions, in a row of elements 10 staplers; - staple the stomach to the esophagus with a first grouping depth and staple the stomach with a second lesser stapling depth; 15 - stapling a pouch with stomach-to-stomach connection sutures in a row of elinent grainpeador, including graw.pear the esophagus with grantpeador elements of greater depth, included as a part of the said row of granulator elements; 20 - suture or staple one or more fleshy ends of stomach tissue in two or more positions in the esophageal tissue, the esophagus having a central esophageal axis, the esophagus still having a substantially cylindrical internal and external surface that extends radially in relation to the central axis 25 of the esophagus, and where the stomach tissue is attached to the esophageal tissue at a first point along a first axis of esophageal surface extension, substantially parallel to said central esophageal axis, and at a second point to the long side of a second axis of esophageal surface extension, substantially parallel to said central esophageal axis, at a distance from said first esophageal surface extension axis, radially errt relative to said central axis of esophagus. esophagus; - release the fastening elements by means of a unit such as 1, located in said instrument; - penetrating at least one layer of the stomach tissue and one layer of the esophageal tissue with said fixing elements; - placing said fixation elements above the gastroesophageal junction, to create an elongated passage between the esophagus and c) stomach, above said junction; - allow the unsteady passage of a substantially unrestricted contraction and release the sperm from the sphincter muscle that closes the cardia at the junction, when such an elongated passage has been created - place a part of the esophagus in the esophagus and a part of the stomach in the stomach through an introduction into the stomach cavity; - placing the fixation element substantially between the stomach and part of the esophagus; - insert said instrument into the main cavity of the stomach, below said junction and being adapted to direct the instrument in the cranial direction, to reach a position of the right unit above said junction; - to operate a joint comprised in said instrument, to enable said instrument to be inserted into the main cavity of the stomach, bending said joint in a certain direction, in order to reach a position of said part of the unit in the esophagus, ending of said junction. 206. Method of using an apparatus, according to any of claims 1-203, characterized by the fact that said method comprises one or more of the following laparoscopic operational steps: - cutting a patient's skin; - insert a tube through the abdominal wall; - fill the abdominal cavity with fluid or gas; 42, / 45 - introduce two or more trocars into the abdominal cavity; - insert a camera into the abdominal cavity through one of the trocars; 5 - introducing said instrument into the abdominal cavity through a trocar; - connect the instrument to the stomach; - lower the instrument into the stomach wall to create at least one pre-molded stomach wall pouch; - tightening the stomach wall to create at least one pre-shaped stomach wall pouch; - suture or staple at least a pouch on the stomach wall; - filling said at least one pouch with a fluid and / or a volume filling device, or with two or more volume filling devices; - Release a plurality of volume filling devices within said pouch created in the stomach tissue, through a tubular element; - pass through the stomach wall, inside the stomach, with said instrument; - passing through the stomach wall I ran said instrument, for placing a volume filling device inside the stomach wall; - pass through the stomach wall with the right instrument, to suture the stomach wall to the esophageal wall; - place a volume filling device outside the stomach wall; - sheathing said volume filling device against the stomach wall; - place a subcutaneous injection port; - suture or staple the stomach wall with the stomach wall outside the stomach; - suture or sew two layers of stomach wall to one or two falls of the stomach wall; - suture or staple the stomach wall with the stomach wall outside the stomach, without penetrating the mucosa; - connect the instrument with the esophagus; - squeeze both sides of the esophagus to attach a layer of esophageal wall to the stomach tissue; - tighten clamps on the sides of the esophagus and the back wall of the stomach to fix a layer of esophageal wall to one or two layers of tissue in the stomach; - introducing a tube or gastroscopic instrument into the esophagus, comprising an anvil element or a fixation release element, which is involved in fixing the esophagus to the stomach; - coordinating the position of the anvil element or a fixing release element within the esophagus in relation to said tightening instrument, around the esophagus; - suturing or stapling a layer of stomach tissue to a layer of esophageal tissue; - suture or staple two layers of stomach tissue to a layer of esophageal tissue; - suture or staple three cartons of tissue from the stomach to a layer of esophageal tissue; - suture or staple four layers of stomach tissue to a layer of esophageal tissue; - to provide stapling using stapling elements of different stapling depths, in different positions, in a row of staple staple; - grant the stomach to the esophagus with a first stapling depth and staple the stomach with a second lower stapling depth; - grawpear a pouch with sutures connecting the stomach to the stomach in a row of stapling elements, further comprising stapling the esophagus with stapling elements of greater depth, included as part of said row of stapling elements; - suture or staple one or more layers of stomach tissue in two or more positions in the esophageal tissue, the esophagus having a central esophageal axis, the esophagus also having a substantially cylindrical internal and external surface that extends radially in relation to the central axis of the esophagus, and then the tissue of the sternum is attached to the esophageal tissue at a first point along a first axis of extension of the esophageal surface, substantially parallel to said central axis of the esophagus, and at a second point along a second esophageal surface extension axis, substantially parallel to said central esophageal axis, the distance from said first esophageal surface extension axis, radially in relation to said central esophageal axis ; - release the fastening elements by means of a unit placed on said instrument; - penetrate at least one layer of the stomach tissue and one layer of the esophageal tissue with said fastening elements; - placing said fixation elements above the gastroesophageal junction, to create an elongated passage between the esophagus and the stomach, above said junction; - allow the elongated passage to make a substantially unrestricted contraction and release the meswa from the sphincter muscle that closes the cardia placed in said junction, when such an elongated passageway has been created - place a part of the esophagus in the esophagus and a part of the stomach in the stomach, through an introduction into the stomach cavity; - attaching the fixing element substantially between the stomach and part of the esophagus; - insert said instrument into the main cavity of the stomach, below the right junction and being adapted to direct the instrument in the cranial direction, to reach a position of said unit above said junction; - operate a joint comprised in said instrument, to enable said instrument to be inserted into the main cavity of the stomach, bending said joint in a certain direction, in order to reach a position of said part of the unit in the esophagus, above that joint. +,. ;; ., m 1/51 Á ¶ Fig.l '\) "") ~ ->, L - ^ "\} C À t J t L b 7 ¶ t L y 1% I ¶ L B ¶ {i L T '. 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