BRPI1007498B1 - OBESITY TREATMENT - Google Patents

Abstract

treatment of obesity the present invention is related to an apparatus for the treatment of obesity, which comprises a volume filling device formed of at least two segments which, after implantation, is placed resting against the patient's stomach wall, so as to reduce the internal volume of the stomach, thereby affecting the patient's appetite.

Description

Technical Field

The present invention relates to an apparatus, system and method for treating obesity.

Background of the Technique

Obesity has been treated with 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 down the band. Also, it has been tried to use electrical stimulation of the stomach wall in order to make the patient feel full.

When the stomach is distended, the patient has the feeling that the stomach is full.

Another way mentioned by the state of the art to treat obesity is to introduce a balloon-like object into the patient's stomach. Thus, the patient feels full much more quickly when eating, avoiding excessive food intake. However, these balloon-like objects mentioned by the state of the art are subject to stomach acids, which causes their destruction in just two months of use.

An example of an inflatable gastric device cited in the prior 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, adjacent to the stomach. An adjustment port is provided subcutaneously and the balloon is subsequently inflated by inserting a hypodermic needle through the patient's skin at the adjustment port and with the introduction of a fluid under pressure at the adjustment port for passage into the balloon. so as to distend the upper abdomen, compressing the stomach and thus providing a feeling of fullness.

Invention Summary

The aim of the present invention is to provide apparatus, system and methods for treating obesity with improved long-lasting properties.

This and other objectives are achieved by means of the apparatus described in the appended claims. In general terms, the present invention relates to an apparatus for treating obesity in a human or animal mammalian 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 portion of a patient's stomach wall, wherein said volume filling device is adapted to be placed with its outer surface bearing against the wall of the patient. stomach, so that the volume of the food cavity is reduced in size by a volume that substantially exceeds the volume of the volume filling device when the volume filling device is sheathed in the wall of the stomach. The volume filling device is adapted for disassembly within its segments if the device leaves its sheathed position and implanted in the stomach and inadvertently penetrates the stomach wall, locating itself within the stomach and including its penetration into the stomach wall, so as to maintain a position within the stomach, wherein 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 patient's intestine. Preferably, the volume filling device has a maximum perimeter of at least 15 millimeters, more preferably at least 30 millimeters. Preferably, the segments of the volume filling device have at least a portion of an outer surface that includes a biocompatible material. By sheathing the volume filling device through the stomach wall on the outside of the stomach wall, this device is protected from stomach acids and thus will remain in operation for a long period of time.

According to an alternative, the volume filling device is adapted to be placed within the stomach, with its outer surface resting against the interior of the stomach wall, so that the volume of the food cavity is reduced in size, by a volume that exceeds the volume of the volume filling device. The volume filling device preferably is adapted to be placed inside the stomach with a gastroscope.

According to another alternative, the volume filling device is adapted to be placed on the outside of the stomach wall, with its outer surface abutting against the outside of the stomach wall, so that the volume of the food cavity is reduced in the 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 externally to the stomach wall by means of a gastroscopic instrument.

To that end, the segments of the volume filling device may comprise a clamping device adapted to cooperate with a clamping instrument. Suitably, the volume filling device is adapted to be non-invasively adjustable in the post-operative stage.

Preferably, the volume filling device is adapted to collapse into its segments if it allows it to be placed with its outer surface resting against the wall of the stomach, i.e. its implanted, at least partially sheathed position. The segments preferably are adapted to separately pass through the path of the food passage, thereby reducing the risk of causing iliac obstruction in the patient's bowel. The segments of the volume filling device may 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 within the device or to 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 outer 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 confinement wall defining a chamber. Thus, at least one of the segments of the volume filling device may be adapted to be filled with at least one of a fluid, a foam, a gel or a fluid which hardens into a solid material. In one embodiment, the segments of the volume filling device comprise a homogeneous and/or solid material, e.g., 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 connected thereto, for fluid supplementation to the chamber. It is preferred that the segments of the volume filling device are adapted to be temporarily held in their installed position, preferably by the sheathed stomach wall 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 of another segment, so that the segments through engagement of the mounting elements can be installed inside the implantable volume filling device. Preferably, the segments for that purpose comprise a core part and a plurality of external parts and preferably said at least one mounting element is selected between flanges and slits of sufficient engagement. 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 of the external parts, when installing the volume filling device. In one embodiment, the slits are distributed around the outer perimeter area of the core portion. The external parts are then provided with flanges, which sufficiently fit 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 portion along a first plane when in motion, and wherein the segments of the volume filling device and the core part further comprises a second mounting element, which after assembling said segments and the core part, immobilizes each segment and the core part along a second plane, making an angle with said first plane. So, for example, the foreground and the background 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, while said at least one mounting element further comprises projections and recesses. Preferably, said at least one mounting element comprises a mounting slot in the core portion and a mounting flange on 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 portion 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 assembling the segments of the volume filling device to form a volume filling device. Preferably, the guide device is an operating wire, operatively connected to the segments.

The operating wire can be made of a material that is biodegradable when in contact with body fluid in the abdominal cavity so as to facilitate disassembly of the volume filling device into its segments. In order to aid the assembly procedure, each segment can be provided with at least one mounting element, which, sufficiently, fits with at least one mounting element of another segment, so that the segments by snapping-in. of the mounting elements can be installed on the volume filling device or form the same. In one embodiment, the segments comprise a core portion and a plurality of outer portions, and in one embodiment, the mounting elements are selected between flanges and slits of sufficient fit. The core portion 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 flanges from the outer parts when installing the volume filling device. Preferably, the slits are distributed around the outer peripheral area of the core part. Slots and flanges can be designed to have a loose fit, adapted to hold the segments together when the volume filling device is in its deployed position, but it helps in disassembling the device if it inadvertently leaves that position, for example , to the stomach cavity. In such a case, the decomposition of the guide device will also aid in the disassembly of the volume filling device into 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 outer parts, so that the outer parts can be sequentially mounted to the core part, to enable mounting of the volume filling device. To this end, the operating wire is connected to the outer part mounting flanges and preferably the core part is provided with at least one operating channel for receiving the operating wire. Preferably, each outer part is connected to two operating channels by the operating wire. In one embodiment, a first operating channel has a first hole in an end surface of the core portion and a second hole in a first slot of the core portion, so that when moving the operating wire received in said first operating channel , 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 of the core part, so that when moving the operating wire connected to the first operating channel in a direction of said end surface, a second outer part is mounted to said part. of core. Preferably, the guidewire protrudes from the first channel hole, so that it can be operated with an instrument to displace the guidewire and a first outer element, thus its mounting flange fits with its first projecting mounting slot in the core element, and in a predetermined sequence and in the same way, displacing the remaining external elements so as to provide the assembly of the implantable volume filling device. The segments may comprise three or more outer parts fitted to the protruding slots of the core part, with the guide wire through the operating channels having holes in each protruding slot of said core part. In one embodiment, the volume filling device comprises a core part and four outer parts. However, other ways of designing the segments within the present concept are feasible, as can be understood by experts versed 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 fixation device, suitably two or more fixation devices, adapted to be involved in the fixation of the volume filling device to the wall of the stomach. The volume filling device, including at least one of its segments, may comprise a support device, adapted to be supported by an instrument, suitably two or more support devices, in order to simplify the implantation of the device.

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

In one embodiment, the volume filling device including at least one of its segments is inflatable to an expanded state, comprising a confining wall defining a chamber, wherein 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 for supplying 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 may 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 device inflatable and the gastroscopic instrument.

The volume filling device can include a homogeneous material, such as a gel, having a Shore hardness value of less than 15. The device can also be a solid body.

The volume filling device, including at least one of its segments, may comprise a rigid, elastic or flexible external surface. When the outer surface is rigid, it will be rigid enough to remain undeformed when subjected to the forces created by the movements of the stomach. The volume filling device may comprise a flexible inelastic material.

According to a first general model of the volume filling device, the device presents a maximum perimeter when viewed in a plane perpendicular to an axis of the device. The device's perimeter, 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 shaped, spherical shaped or substantially shaped like an egg with a notched intermediate section, or like a curved egg.

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 it increases at least once when the plane is moved along said axis. Thus, for example, the device may be substantially in the shape of a kidney.

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

The volume filling device, in yet another modality, 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 midpoint of said axis to a third midpoint with a second maximum point, and still where the perimeter constantly decreases or remains constant when moving the from said third intermediate point to a second extreme point of said axis.

Further 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 m3, or from 0.00001 to 0.001 m3, or from 0.00001 to 0.0002 m3. The volume of the volume filling device, in yet another modality, has a volume of less than 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, may 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 polytetafluoroethylene layer or a polyurethane layer. 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 inner surface layer of polytetrafluoroethylene and an outer layer of silicone, an inner surface layer of polytetrafluoroethylene, an inner surface layer of silicone and an outer layer of Parylene®, an inner surface layer of polyurethane and an outer layer of silicone, and an inner surface layer of polyurethane, an intermediate layer of silicone and an outer layer of Parylene®.

The volume filling device, including at least one of its segments, may comprise a fluid, adapted to be transformed into a solid state or into a fixed form. This fluid can be liquid polyurethane or isotonic. The fluid can comprise large molecules, such as iodine molecules, to prevent eventual diffusion.

The volume filling device can have a maximum perimeter of at least 50 millimeters, preferably at least 80 millimeters. 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 to be held in place by means of stomach-to-stomach connecting sutures or staples 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. The stomach-to-stomach connecting sutures or staples may be provided with attachment portions that exhibit a structure adapted to be disposed in contact with the stomach wall, to promote the growth of human tissue, to secure as a long-term placement, the volume filling device to the stomach wall. The structure may comprise a network-like structure.

In one embodiment of the invention, the apparatus comprises a stretching device, placed externally to 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 for operating the stretching device when implanted, to stretch the portion of the stomach wall, so that a feeling of fullness is 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 stretching device are implanted to stretch the wall portion of the stomach in connection with the patient's feeding so that a feeling of fullness 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, wherein 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 portion of stomach wall so that a feeling of fullness is created. A control device may 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 for controlling 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 sensing device to be implanted in the patient's body may be provided, wherein the implantable control unit is adapted to control the stretching device from within the patient's body using information from said sensor or sensing device, adapted to 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, wherein the stretching device comprises an expandable reservoir, adapted to be sheathed in the stomach wall, at the top of the stomach, higher than the main inflatable volume filling device when the patient is standing upright. that the volume filling device is inflatable and is in fluid connection with said stretching reservoir, wherein normal contractions of the stomach wall correlated with food intake cause fluid to circulate from said volume filling reservoir main sheathed, placed in a lower position on the stomach wall, adapted to oblige said res. stretching herb to stretch said portion of stomach wall so that a feeling of satiety is created. The fluid connection between the reservoir of the main volume filling device and the stretching reservoir comprises a back pressure valve. The fluid connection between the reservoir of the main volume filling device and the stretching reservoir comprises a release function adapted to release the volume from the stretching reservoir back to the reservoir of the main volume filling device. Said release function may comprise a fluid return connection of a substantially smaller area than said fluid connection to slowly return fluid to said main volume filling device reservoir from said stretching reservoir to release the said stretching the stomach wall portion. A further manual control device, comprising a subcutaneously placed reservoir, 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 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 stretching device operable, implantable in an obese patient and adapted to stretch a portion of the stomach wall of a patient, 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 substantially affected by said fibrosis. An operating device for operating the stretching device may be provided to stretch the stomach wall portion so that a feeling of fullness 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 feeding, so that a feeling of satiety is created.

In one embodiment, the apparatus comprises a stretching device, comprising at least one stretching device operable, implantable in an obese patient, and adapted to stretch a portion of the stomach wall of a patient so that a feeling of fullness 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 sensing device, adapted to be implanted in the patient's body may be provided, wherein the implantable control unit is adapted to control the stretching device from within the patient's body, using information from said sensor or sensing 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 connected individually with different parts of the stomach wall, wherein said engagement includes suturing or stapling the stomach wall, or sheathing the mechanical parts in the stomach wall portion with stomach-to-stomach connecting sutures, wherein the three or more mechanical parts are adapted to move relatively to each other, adapted to stretch three different wall portions, the stretching device being further adapted to have the said wall portions stretched independently of each other, taking into account the force used to stretch the stomach wall portion, as well as the time periods in which the stretch is applied, and when the stretch is applied.

In one embodiment, the apparatus further comprises a stretching device comprising two or more hydraulic parts, individually connected with different parts of the stomach wall, wherein said connection includes suturing or stapling the hydraulic part to the stomach wall, or sheathing of the hydraulic parts in the stomach wall portion with stomach-to-stomach connecting sutures, wherein 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 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 time periods in which the stretch is applied and also when the stretch is applied .

In one embodiment, the apparatus further comprises a stretching device, which is connected with a portion of the stomach wall, including suturing or stapling the stretching device to the stomach wall, or sheathing the stretching device in the wall portion. of the stomach with stomach-to-stomach ligation 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 periods of time in that the stretch is applied and also when that stretch is applied.

In one embodiment, the apparatus further comprises a stretching device comprising two parts connected individually with 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 stomach portion. stomach wall with stomach-to-stomach connecting sutures, wherein the stretching device is further adapted to have different wall portions stretched independently of each other, controlling the force used to stretch said stomach wall portion as well as the periods the time the stretch is applied and also when that stretch is applied.

In one embodiment, the device is further adapted for the treatment of reflux disease. To that end, the apparatus further comprises an implantable volume filling device, adapted to at least partially be sheathed by the fundus wall of the patient's stomach, and having an outer surface that includes a biocompatible material, of which a substantial portion of the external surface of the volume filling device is adapted to rest against the stomach wall, without causing damage thereto, in a position between the patient's diaphragm and at least a portion of the lower portion of the sheathed stomach back wall, of so that the movement of the cardiac incision from the patient's stomach towards his diaphragm is restricted when the volume filling device is sheathed, to thereby prevent the cardia from sliding through the opening of the patient's diaphragm into his chest, in order to maintain the support pressure against the patient's cardia sphincter muscle, exerted by the patient's abdomen, the filling device the volume one having a volume of at least 125 mm3 and a perimeter of at least 15 mm.

In another embodiment, the apparatus is further adapted for the treatment of reflux disease. To that end, the apparatus further comprises an implantable volume filling device, having an outer surface that includes a biocompatible material, wherein the movement restriction device is adapted to bear with at least a portion of its outer surface against the fundus wall of the patient's stomach, in a position between the patient's diaphragm and the fundus wall, so that movement of the patient's stomach cardiac incision towards his diaphragm is restricted when the movement restriction device is implanted in the patient, to thereby prevent the cardia from sliding through the opening of the patient's diaphragm into his chest, in order to maintain the supporting pressure against the patient's cardia sphincter muscle, exerted by the patient's abdomen, the volume filling device having a volume of at least 125 mm3 and a perimeter of at least 15 mm, and a clamping device adapted to secure the device volume filling device in said position when the volume filling device is implanted.

In another embodiment, the device is further adapted to treat reflux disease. To that end, the apparatus further comprises an implantable movement restriction device, adapted to be at least partially sheathed by the patient's bottom wall of the stomach, and having an outer surface that includes a biocompatible material, wherein a substantial portion of the surface. The external part of the movement restriction device is adapted to rest against the stomach wall, without causing damage thereto, in a position between the patient's diaphragm and at least a portion of the lower portion of the sheathed stomach wall, so that movement of the cardiac incision from the patient's stomach towards his diaphragm is restricted when the movement restriction device is sheathed in the patient, to thereby prevent the cardia from sliding through the opening of the patient's diaphragm into his chest, in order to maintain the support pressure against the patient's cardia sphincter muscle, exerted by the patient's abdomen, the device. A movement restriction device having a volume of at least 125 mm3 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 patient's stomach wall, so that a feeling of satiety is created.

In another embodiment, the device is further adapted to treat reflux disease. To that end, the apparatus further comprises an implantable movement restriction device, having an outer surface that includes a biocompatible material, wherein the movement restriction device is adapted to bear with at least a portion of its external surface against the fundus wall of the patient's stomach, in a position between the patient's diaphragm and the fundus wall, so that movement of the patient's stomach cardiac incision towards his diaphragm is restricted when the movement restriction device is implanted in the patient, to thereby prevent the cardia from sliding through the opening of the patient's diaphragm into his chest, in order to maintain the supporting pressure against the patient's cardia sphincter muscle, exerted by the patient's abdomen, in that the movement restriction device has a volume of at least 125 mm3 and a perimeter of at least 15 mm, and a securing device adapted to secure the movement restriction device in said position when the movement restriction device is implanted, 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 stomach wall of a patient so that a feeling of satiety is created.

In one embodiment, the apparatus further comprises an external control unit for controlling 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 a 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 device. detection, 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 of 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 the stomach wall of a patient, and having an outer surface that includes a biocompatible material, wherein the volume filling device is adapted to be placed within the stomach, with the outer surface of the volume filling device abutting against the interior 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 30 mm.

In a preferred embodiment, the apparatus comprises at least one switch implantable in the patient for manually and non-invasively controlling the volume filling device.

In another preferred embodiment, the apparatus comprises a wireless remote control device for non-invasively controlling the volume filling device.

In a preferred embodiment, the apparatus comprises a hydraulic operating device for operating the volume filling device.

In one embodiment, the apparatus comprises a motor or a pump to operate the volume filling device.

In one embodiment, the apparatus comprises an adjustment device for adjusting 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 wherein the size of the volume filling device is not non-invasively regulated by moving hydraulic fluid from the reservoir to at least one segment of the volume filling device, thereby adjusting the size of at least one segment of the filling device of volume. The apparatus may further comprise a hydraulic regulation 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, if arranged in connection thereto, and in that the amount of hydraulic fluid contained in at least one of the segments of the volume filling device is non-invasively regulated by the dispensing 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, so as to stretch the bottom wall, to create a feeling of satiety in the patient. The adjustment device may further comprise a reverse servo mechanism 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 including a second reservoir, is compressed with a high force per unit area, to move a small volume of hydraulic fluid, and where the second reservoir affects a greater volume of hydraulic fluid in a third reservoir, the third reservoir being part of a second closed system, having a volume greater than of said first reservoir, thereby creating a movement of a greater total volume of hydraulic fluid, with less intensity of force per unit area. The apparatus of the discussed embodiment may comprise a wireless remote control device, wherein the volume filling device when implanted in the patient is non-invasively regulated by the wireless remote control device. The apparatus of the discussed embodiment may further comprise an energy source that drives the adjustable volume filling device 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 power wirelessly. The internal energy source, when implanted in the patient, can be charged by wireless energy transmitted by the external energy source. The wireless remote control device may comprise at least one external signal transmitter and receiver, further comprising an internal signal receiver and 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 a magnetic field.

In one embodiment, the apparatus comprises a wireless power transmitter to non-invasively energize any part of the apparatus in need of supplemental power. The power transmitter preferably transmits power via at least one wireless power signal. Preferably, the wireless power comprises a signal or a wave field or the wireless power signal may comprise an electric or magnetic field, or a combination of 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 transforming device, which transforms wireless energy into electrical energy, wherein the electrical energy is used to, at least partially, charge the accumulator or to process any part consumer of the appliance, directly from the energy transformation device.

In one modality, the device comprises a sensor that detects a parameter, which parameter can be a functional parameter or a physical parameter of the patient. The functional parameter is correlated with a wireless energy transfer to charge an internal energy source implantable in the patient. The apparatus may further comprise a feedback device, which when implanted in the patient, sends feedback information from within the patient's body to the outside thereof, 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 the sensor's detection of the functional parameter. The sensor to detect the physical parameter is a pressure sensor or a motion sensor. An internal implantable control unit can control the device's volume filling device in response to the sensor's detection of the physical parameter.

In one embodiment, the apparatus comprises an operating device for operating the volume filling device in order to control its size and/or shape. To that end, the operating device may comprise a motor or a pump.

In one embodiment of the apparatus, the volume filling device is adapted to further receive wireless energy, wherein the wireless energy is used to drive the operating device so as to create kinetic energy for operation of the volume filling device. volume. Wireless energy can, for example, be used to directly drive the operating device so as to create kinetic energy for the operation of the volume filling device, as wireless energy is transmitted by the transmission device. energy. The volume filling device can also be adapted to receive energy from an energy transforming device directly during wireless energy transfer, or from an energy accumulator, being rechargeable by the wireless energy and the energy transforming device. . 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 microwave signal, a radio wave signal, an X-ray radiation signal, and a gamma radiation signal. The wireless power signal may also comprise an electric or magnetic field or a combination of electric and magnetic field.

In one embodiment of the apparatus, it further comprises implantable electrical components including at least one voltage level protector, or at least one constant current protector.

In one embodiment of the apparatus, at least one of the segments of the volume filling device has at least one flat surface. Preferably, the segments of the volume filling device are in 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 filling device. Such friction-increasing material preferably is a glue or an adhesive. Alternatively, at least one of the segments of the volume filling device has a rough textured surface.

In one embodiment of the apparatus, at least one of the segments of the volume filling device is spherical in 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. 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 friction between adjacent segments of the volume filling device.

The apparatus may comprise a second volume expandable filling device segment for including two or more first volume filling device segments different from the second volume filling device segment, wherein the second filling device segment of 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 inner surface thereof, wherein the friction-reducing material is disposed 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 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. Then, 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 portion of the patient's stomach wall via a tubular instrument.

In one embodiment, the volume filling device comprises a liquid having a solidifying property. Such liquid or fluid may be provided to the pouch via a conduit.

In one embodiment, the plurality of volume filling device segments are adapted to be interconnected to form the volume filling device after said plurality of volume filling device segments have been inserted into a human or human pouch. artificial.

The apparatus is characterized in 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. Generally speaking, any applicable feature or modality or part of the modality or method described herein are, where 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, apparatus part or system, or system part or any claimed embodiment, described elsewhere herein.

The invention comprises a method or method part, to be used in any combination and using any apparatus or apparatus part, or any feature in any combination, where the following method steps are applicable, wherein said method may comprise one or more of the following operational steps: - introduce an instrument into the throat; - lower the instrument through the esophagus; - place an anvil or a unit to release fasteners 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 visualization guide when said instrument comprises a camera; - connect the instrument with the stomach; - create and suture at least one stomach wall bag; - fill said at least one bag with a flu and/or one volume filling device, or two or more volume filling devices; - releasing a plurality of volume filling devices into said pouch created in the tissue of the stomach, through a tubular element; - passing through of the stomach wall with said instrument; - pass through the stomach wall with said instrument, for placement of a volume filling device outside the stomach wall; - pass through the stomach wall with said instrument, for placement a tube that allows placement of a subcutaneous injection port; - place a subcutaneous injection port; - suture or staple the stomach wall from its interior into the esophagus; - suture or staple the connection of the stomach wall to the stomach wall from the inside of the stomach; - connect the instrument to 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 esophageal tissue; - suture or staple three layers of stomach tissue to one layer of esophageal tissue; - suture or staple four layers of stomach tissue to one layer of esophageal tissue; esophagus; - suture or staple one or more layers of stomach tissue to two or more positions in the esophageal tissue, the esophagus having a central esophageal axis, the esophagus further having a substantially cylindrical inner and outer surface that extends radially relative to the central axis of the esophagus, and wherein 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 axis. the central esophageal axis, and at a second point along a second esophageal surface extension axis, substantially parallel to said esophageal central axis, at a distance from said first esophageal surface extension axis, radially relative to the said central axis of esophagus; - release the fixation elements by means of a unit placed on said instrument; - penetrate into at least one layer of stomach tissue and into a layer of esophageal tissue with said fixation elements; - place said fasteners above the gastroesophageal junction, to create an elongated passage between the esophagus and the stomach, above said junction; - place an esophageal part in the esophagus and a stomach part in the stomach; - place the fastening 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; - allowing the elongated passage to contract substantially unrestricted and releasing it from the sphincter muscle that closes the cardia placed at said junction, when such elongated passage has been created.

The invention comprises a method or method part, to be used in any combination and using any apparatus or apparatus part, or any feature in any combination, where the following method steps are applicable, wherein said method comprises one or more of the following operational steps: - cutting a patient's skin; - creating an opening in the patient's abdominal wall; - introducing said instrument into the abdominal cavity, through said opening in the abdominal wall; - connecting the instrument with the stomach; - press down the instrument into the stomach wall so as to create at least one pre-molded stomach wall pouch; - staple the stomach wall to create at least one pre-molded pouch of stomach wall; - suturing or stapling at least one pouch to the stomach wall; - filling said at least one pouch with a fluid and/or a volume filling device, or two or more fluid filling devices. volume; - release 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 placing a volume filling device within the stomach wall; - passing through the stomach wall with said instrument, to suture the stomach wall to the esophageal wall; - placing a device of volume filling outside the stomach wall; - sheathing said volume filling device in the stomach wall; - placing a subcutaneous injection port; - suturing or stapling 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; - suture or staple two layers of stomach wall to one or two layers of stomach wall; - connect the instrument to the esophagus; - pinch both sides of the esophagus to secure a layer of esophageal wall to the tissue of the stomach; - pinch both sides of the esophagus and the wall of the fundus of the stomach, to secure a layer of esophageal wall to one or two layers of tissue from the stomach. stomach; - inserting a gastroscopic tube or instrument into the esophagus, comprising an incus element or a fixation release element, which engages in fixation of the esophagus to the stomach; - coordinate the position of the incus element or a release element of attachment within the esophagus, in relation to said clamping instrument, around the esophagus; - suturing or stapling a layer of stomach tissue to a layer of esophageal tissue; - suturing or stapling two beds - suturing or stapling three layers of stomach tissue to one layer of esophageal tissue; - suturing or stapling four layers of stomach tissue to one layer of esophageal tissue; by using stapling elements of different stapling depths, in different positions, in a row of stapling elements; - stapling the stomach to the esophagus with a first stapling depth and stapling the stomach to stomach with a second smaller stapling depth; - stapling a pouch with stomach-to-stomach connecting sutures in a row of stapling elements, further comprising stapling the esophagus with stapling elements of greater depth included as a part of said row of stapling elements; - suturing or stapling one or more layers of stomach tissue at two or more positions in the esophageal tissue, the esophagus having a central esophageal axis, the esophagus further having a substantially cylindrical inner and outer surface that extends radially from the axis central esophagus, and wherein the stomach tissue is attached to the esophageal tissue at a first point along a first esophageal surface extension axis, substantially parallel to said esophageal central axis, and at a second point along a a second axis of esophageal surface extension, substantially parallel to said central axis of esophagus, at a distance from said first axis of esophageal surface extension, radially relative to said central axis of esophagus; - releasing the fastening elements by by means of a unit placed on said instrument; - penetrating at least one layer of stomach tissue and one layer of esophageal tissue with said securing elements o; - place said fastening elements above the gastroesophageal junction to create an elongated passage between the esophagus and stomach, above said junction; - allow the elongated passage to contract substantially unrestrictedly and release it from the sphincter muscle that closes the cardia placed at 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, through an introduction into the cavity of the stomach; - 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 the said instrument, to enable said instrument to be inserted into the main cavity of the stomach, bending said joint in a certain direction, so as to reach a position of said part of the unit in the esophagus, above said junction.

The invention comprises a method or method part, to be used in any combination and using any apparatus or apparatus part, or any feature in any combination, where the following method steps are applicable, wherein said method comprises one or more of the following operational laparoscopic steps: - cutting a patient's skin; - introducing a tube through the abdominal wall; - filling the abdominal cavity with fluid or gas; - introducing two or more trocars into the abdominal cavity; - introducing a camera into the abdominal cavity through one of the trocars; - introduce said instrument into the abdominal cavity through one of the trocars; - connect the instrument with the stomach; - lower the instrument into the stomach wall to create at least one pre-molded pouch of stomach wall;- pinch the stomach wall to create at least one pre-molded stomach wall pouch;- suture or staple at least one pouch to the wall of stomach; - filling said at least one bag with a fluid and/or one volume filling device, or with two or more volume filling devices; - releasing a plurality of volume filling devices into said bag created in the stomach tissue, through a tubular element; - pass through the stomach wall, into the stomach, with said instrument; - pass through the stomach wall with said instrument, for placement of a volume filling device inside the stomach wall; - pass through the stomach wall with said instrument, to suture the stomach wall to the esophagus wall; - place a volume filling device outside the stomach wall; - sheath said device volume filling in the stomach wall; - 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; - suture or staple the stomach wall with the stomach wall outside the stomach, without penetrating the mucosa; - connect the instrument to the esophagus; - pinch both sides of the esophagus to secure an esophageal wall layer to the stomach tissue; - pinch both sides of the esophagus and the bottom wall of the stomach to secure an esophageal wall layer to one or two layers of stomach tissue; - introduce a gastroscopic tube or instrument into the esophagus, comprising an incus element or a fixation release element, which engages in fixation of the esophagus to the stomach; - coordinate the position of the incus element or a fixation release element within the esophagus, in relation to said clamping instrument, around the esophagus; - suturing or stapling a layer of stomach tissue to a layer of esophageal tissue; - suturing or stapling two layers of stomach tissue to a layer of tissue esophageal;- suturing or stapling three layers of stomach tissue to one layer of esophageal tissue;- suturing or stapling four layers of stomach tissue to one layer of esophageal tissue;- promoting a m stapling using stapling elements of different stapling depths, in different positions, in a row of stapling elements; - stapling the stomach to the esophagus with a first stapling depth and stapling the stomach to stomach with a second smaller stapling depth; - stapling a pouch with stomach-to-stomach connecting sutures in a row of stapling elements, further comprising stapling the esophagus with stapling elements of greater depth, included as a part of said row of stapling elements; - suturing or stapling one or more layers of stomach tissue at two or more positions in the esophageal tissue, the esophagus having a central axis of the esophagus, the esophagus further having a substantially cylindrical inner and outer surface that extends radially relative to the central axis of the esophagus, and in which the tissue of the stomach is attached to the esophageal tissue at a first point along a first axis. of esophageal surface extension, substantially parallel to said esophageal central axis, and at a second point along a second esophageal surface extension axis, substantially parallel to said esophagus central axis, at a distance from said first axis of esophageal surface extension, radially relative to said central axis of esophagus; - release the fastening elements by means of a unit placed on said instrument; - penetrate into at least one layer of stomach tissue and one layer of tissue esophagus with said fasteners; - place said fasteners above the gastroesophageal junction to create an elongated passage between the esophagus and stomach above said junction; - allow the elongated passage to contract substantially unrestrictedly and release it of 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 stomach into 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 stomach cavity, below said junction and being adapted to direct the instrument in the cranial direction, to reach a position of said unit above said joint; - 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, so as 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 a modality, as well as any method or part of a method, or any apparatus or part of an apparatus, or any feature or part of a feature, or any system or part of a 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 generally possible to combine in any way.

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

Brief Description of Drawings

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 stomach; - the figure 2a is a view of a first embodiment of an obesity treatment apparatus implanted in a human patient; figure 2b is a sectional view taken along line IIb-IIIb as shown in figure 2a; -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 steps of sheathing the inflatable device shown in figure 4a, outside a wall of a patient's stomach;- figures 6a, 6b, 7 and 8 show alternative modalities, in which the volume filling device is adapted to be non-invasively adjusted in a post-operative stage;- figures 9 and 10 show embodiments in which the volume filling device is adapted to be sheathed in the fundus region 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 movement restriction device segments are provided in a pocket created by a part of the stomach wall, without any outer containment layer; Figure 11c shows an embodiment similar to that shown in Figure 49b, but where the closest part of the combined reflux and obesity treatment apparatus has a different composition. the farthest part of the combined reflux and obesity treatment apparatus; figure 12 shows an embodiment in which the volume filling device, also adapted for reflux treatment, is combined with stretching devices to stretch part of the bottom wall Figures 13-16 show alternative embodiments 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 steps of hemming the inflatable device shown in Figure 4a within a patient's stomach wall; Figures 19a-19j illustrate different steps of hemming the Inflatable device shown in Figure 4a, inside a patient's stomach wall; Figures 20a-20f illustrate different steps of sheathing the device. The inflatable valve shown in Figure 4a, within 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 to obesity treatment; 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 various ways of disposing of 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 embodiment according to with figure 51, when a third part and a fourth part are assembled; - 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; - figure 55 shows the core part of the embodiment shown in figure 50, with the operating channels; figures 55b to 55f show cross-sectional views of the core part shown in figure 55a, according to planes II; II-II, III-III, IV-IV, respectively; - figures 56 and 57 show different modalities of the segments of the volume filling device; - figures 58a-58d illustrate the insertion of the segments of the volume filling device shown 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 stomach wall using an instrument; Figure 60 illustrates an instrument alternative 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 volume filling device segments 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 filling device Figure 64 is a view of a volume filling device comprising a plurality of volume filling device segments contained in a fluid; and Fig. 65 is a sectional view of a volume filling device comprising a plurality of volume filling device segments contained in a fluid.

Description of Modalities

Preferred embodiments of the invention will now be described in greater detail with reference to the accompanying figures.

As used herein, the term “segment” should be considered broadly 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 so as 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 greater 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 IIb-IIb 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 in 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 rest against the wall (12a) of the stomach (12) and further has an external surface suitable for resting against that wall.

By sheathing the volume filling device (10) in a part of the stomach wall, the size of the food cavity generally designated (12b) in Figure 2b will be reduced, resulting in a faster feeling of fullness after ingestion. of food.

The volume filling device (10) preferably comprises an elastic material such as silicone. Thereby, the volume filling device can adapt to the movements of the stomach, the degree of food intake, etc.

By providing the volume filling device of a biocompatible material, the risk of the patient's body rejecting the implant is largely reduced.

The volume filling device (10) can be attached to the wall (12a) of the stomach (12) in a variety of ways. In the embodiment shown in Figure 2b, the volume filling device (10) is sheathed in the stomach wall (12a). After sheathing, a number of stomach-to-stomach connecting sutures or staples (14) are applied in order to maintain sheathing for a short period of time. This allows for human tissue to grow, 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 damage the stomach wall. An example thereof is shown in Figure 3a, in which the volume filling device is substantially oval-shaped. In another preferred embodiment, the volume filling device is slightly curved, such as in the embodiment shown in Figure 3b. However, since the stomach wall is strong, many different shapes, designs and dimensions can be used. In one embodiment, the volume filling device has a diameter of approximately 40 mm, and an extension of approximately 120 mm, resulting in a volume that is approximately 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 at least 80 mm.

It is not necessary for the volume filling device to be elongated. In the embodiment shown in Figure 3c, the volume filling device (10) is substantially spherical or in the shape of a ball. In order to fill the stomach, two or more volume filling devices can be combined to obtain the desired decrease in the food cavity of the patient's stomach.

It has been mentioned that the volume filling device is fixed by means of sutures or staples connecting stomach to stomach. 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. Such a 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 further through a hole in the stomach wall. Thus, figure 3e shows a volume filling device comprising two more or less spherical sub-parts (10b, 10c), interconnected by a portion which preferably has a smaller diameter. The portion with smaller diameter may comprise an interconnecting device with a reversible function, which allows a subsequent disconnection of the two interconnected sub-parts (10b, 10c). This device may comprise a bayonet-type socket, a screw connection or the like, designated by (10d) in the figure. Alternatively, the portion with smaller diameter may comprise a fixed interconnection, such as, for example, resilient locking hooks, provided in one of the sub-parts (10b, 10c) and connecting with the edge of a hole provided in the other sub-part. of said sub-parts (10b, 10c).

This configuration of the volume filling device (10) is not limited to a waist portion (10a). Thus, in Figure 3f, a volume filling device is shown which has two waist portions.

In order to facilitate the positioning of the volume filling device, a fixing device in the form of a loop or the like can be provided on the outer 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 fixation device is provided at an end portion of the volume filling device (10). In order to avoid projecting the portion on the surface of the volume filling device (10), the loop (10e) is provided flush with the outer surface of the volume filling device (10), and a recess (10f) is arranged to allow manipulation of a tool or clamping instrument (not shown in figure 3g) so as to obtain a firm grip around the handle (10e).

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

A volume filling device (10) adapted for this is shown in figure 3h. A tube (10g) is securely attached to the volume filling 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.

Rather than having a tube firmly attached, the volume filling device (10) may 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 wall of the stomach in which it is sheathed. To that end, the volume filling device may be provided with one or more hollow holes adapted to receive sutures or staples used for securing the hem. Such an arrangement is shown in figure 3j, where the volume filling device (10) is provided with a row of holes (10i), provided in a flange-like projection, which projects over the volume filling device. In this embodiment, the row of holes extends along the longitudinal axis of the volume filling device.

Figure 3k illustrates how sutures (14) are provided whereby they are disposed through the stomach wall (12a) and through the holes (10i). Thereby, the volume filling device is fixed in place in the pouch created from the stomach wall and thus will be prevented from slipping.

While a plurality of holes is illustrated in Figure 3j, it should be noted that a single hole is sufficient to obtain an improved attachment 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 an inlet port, a fixed tube (10g) extends into the patient's abdominal area.

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 shapes. 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 multi-layer 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 that case, the inflatable device is provided with an inlet port for a fluid and adapted to be connected to a gastroscopic instrument. This modality will now be described in more detail with reference to figures 4a-4d.

An inflatable volume filling device, in its unexpanded state is shown in Figure 4a. In the present case, the deflated device (10) is essentially in the shape of a balloon, having an inlet port (10h). In this state, the inflatable device has a diameter of at most a few millimeters, allowing it to be inserted into the stomach through the patient's esophagus, by means of a tube-type gastroscopic instrument (600), as shown in Figure 4b. The instrument comprises an outer sleeve (600a) and an inner sleeve (600b), which can be displaced longitudinally with respect to the outer sleeve. The inner sleeve is provided with a cutting element in the form of a cutting edge (615) at the far end thereof. 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 forward from its position in the outer glove, and into contact with the stomach wall (12a). The cutting edge (615) of the inner glove then cuts a hole in the stomach wall so as 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 hole, a piston (602) may be provided in the instrument. Thus, the instrument further comprises a piston (602) adapted to drive 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. To that end, the control unit (606) comprises one or more steering devices, in the embodiment 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 within the stomach, such as a camera (not shown) disposed at the outer end of the elongate element (607), see Figures 5e-5i . The camera, which may comprise electrical connection wires extending along the elongate element, can be aided by a light source (not shown) placed farther away from the elongate 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 of the interior of the stomach. The instrument is further inserted into the esophagus and into the patient's stomach (see figure 5b) .

By means of the instrument (600), a hole (12b) is created in the wall of the stomach (12). To that end, the instrument is provided with one or more cutter elements (615) at the far end thereof, for example, in the manner described above with reference to figures 4a-4d. These cutter elements, of course, 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 far end of the instrument (600) is inserted into the hole (12b) so as 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 cross-sectional view of the stomach shown in Figure 5c is shown, taken along the lines Vd - Vd.

The instrument (600) is adapted to create a “pocket” or “pouch” outside the stomach (12) around the hole (12b) in the stomach wall. Said instrument and the method of providing the grant will now be described.

Figures 5e-5i show a gastroscopic or laparoscopic instrument for sheathing a volume filling device (10) in 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 designated (600) and which may comprise the features described above with reference to Figures 4a-4d, comprises an elongate element (607) having a nearer end and a far end, the elongate element (607) having a diameter smaller than that of the patient's esophagus and being flexible so as to allow the introduction of the flexible elongate element (607) with its farthest first end through the patient's throat, esophagus and into the stomach (12), reaching at the end the stomach wall (12a).

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

The elongate element further comprises an expandable element (611), which is adapted to be expanded after the elongate element has penetrated the stomach wall (12a), thereby aiding in the creation of a cavity or pouch adapted to support the device. volume filler (610). The expandable element (611) may comprise an inflatable circular balloon provided circumferentially around the distal end portion of the flexible elongate element (607).

The method steps 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 penetration device (615) is placed in contact with the stomach wall (12a), see figure 5e. The penetration device or stomach cutter element (615) is then arranged to create the hole (12b) in the stomach wall, after which at least the expandable element (611) is disposed through the hole (12b) in the wall. of the stomach. The special support device (609), at this stage, is arranged in a support state, where it expands radially, so as to form a support surface substantially circular with the stomach wall (12a), see figure 5f. Thereby, 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 case the expandable element comprises a balloon or similar element, air or other fluid is injected into it.

The portion of the elongated element (607) comprising 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 cup, created by the special support device (609).

A suturing or stapling device (608) is further provided, in the form of a device connected to the elongate element (607) or in the form of a separate instrument. The suturing or stapling element comprises a suturing or stapling end (613), which is adapted to close the cavity or pouch by means of stomach-to-stomach connecting sutures or staples (14).

In a further step, illustrated in figure 5h, an inflatable volume filling device (10) is arranged in its deflated state on 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. Furthermore, it can also be obtained by injecting a material that is allowed to cure, thereby forming a solid device (10). Thus, the volume filling device (10), as shown in Figures 5h and 5i, can illustrate a balloon-like device, which is then filled with fluid or gel or, alternatively, with a material that is simply injected into the type structure. cup, 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 to 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 iodine molecules.

The stomach-to-stomach connecting sutures or staples preferably are provided with attachment portions which exhibit a structure, such as a mesh-like structure, adapted to be disposed in contact with the stomach wall so as to promote the growth of human tissue, to fasten for a long time the placement of the volume filling device fixed to the stomach wall.

After the inflatable device (10) has been inflated, partially or fully, the inlet port (10h) (not shown in figures 5h and 5i) of the volume filling device (10) is sealed and the instrument (600) is retracted of the hole (12b), which is then closed in some suitable way, such as 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, external to 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 may 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 obesity treatment apparatus 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 in the stomach wall, externally therefrom. , together with a system for regulating 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 a fluid for inflation. Thus, the inflatable device (10) forms a fluid chamber in which fluid is allowed to circulate. The inflatable device thereby forms an expandable chamber, which can change the volume it occupies in the stomach wall, thus forming a hydraulically or pneumatically regulated inflatable device.

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 non-invasively, by moving liquid or air from the injection port (16) to the chamber formed by the inflatable device. By using a hypodermic needle or the like, 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 regulation reservoir (17) can be regulated in different ways. In an alternative embodiment, the regulating tank (17) is regulated by manually pressing a regulating tank. In other words, the regulation vessel is regulated by moving a vessel wall. It is then preferred that the regulation reservoir is placed subcutaneously, whereby regulation is obtained non-invasively.

A similar modality is shown in figure 6b. However, in this mode, the injection port (16) has been replaced by an adjustable regulation reservoir (17), in fluid connection with the volume filling device (10) through a tube (18). When the regulation 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 conduit or tube (18), expanding or expanding the inflatable device (10). In this way, the volume filling device is non-invasively adjustable in a post-operative stage.

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 regulation reservoir has a locking position so as to keep it in the desired position. If the patient compresses the reservoir, it is preferable that it remains compressed and is released after pressing again.

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.

In another embodiment, as shown in figure 7, a motor (40) is adapted to move a wall of the regulation reservoir (17). The actuated regulating reservoir (17) is then preferably placed in the patient's abdomen. In this modality, an external wireless remote control unit, which is part of the external power transmission device (34), can be provided to perform a non-invasive regulation of the motor, through an energy transforming device ( 30), which is adapted to supply power to an energy-consuming operating device, in the present example, the motor (40), via a power supply line (32).

The remote control device can comprise a wireless power transmitter, whereby regulation is non-invasively performed by the power transmitter. When regulation is carried out by means of a remote control device, an internal source of energy for activating the regulation device is provided. The internal source of energy can be, for example, an implanted 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 obesity treatment apparatus comprises a pump (44), wherein the reservoir is regulated by the pump (44), which pumps 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 obesity treatment apparatus will now be described with reference to Figure 9, which shows a stomach (12) of a patient who is being 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 stomach of the patient (12). However, in this case, the sheathing was performed in the bottom, that is, in the upper portion of the stomach, where the number of receptors in the stomach wall is large, and the inflatable device works as a stretching device for the bottom wall part. of the stomach.

A regulation 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 regulation reservoir (17) to the chamber formed by the inflatable device (10). The regulation of the inflatable device (10) preferably comprises an inverse servo mechanism, i.e. a small volume is actuated, for example, by the patient's finger, this small volume being in connection with a larger volume, i.e. the reservoir of regulation (17).

Thus, the inflatable device (10) is placed externally to the stomach wall, being adapted to stretch a part of the bottom wall of the stomach, thereby affecting the patient's appetite. By enlarging the size of the stretching device, the bottom wall of the stomach (12a) surrounding the inflatable stretching device (10) is stretched, as the perimeter of the inflatable stretching device (10) is increased. Through this stretching, receptors in the stomach wall indicate that the stomach is full, thereby creating a feeling of fullness 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 food cavity of the stomach and part of the stretching of the stomach wall, thus increasing the effectiveness of the treatment.

The expansion and contraction of the stretching device (10) can be carried out under the direct control of the patient. Alternatively, expansion and contraction can be performed according to a pre-programmed schedule.

In a preferred embodiment, as shown in figure 10, a sensor (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 obesity treatment apparatus can be automated, wherein the size of the device volume filling (10) in the form of the inflatable stretching device is adjusted depending on the amount of food entering the food cavity of the stomach. Thus, fluid is moved between the inflatable volume filling device (10) and a fluid reservoir (15). The obesity treatment device may have the added functionality of reflux treatment. An embodiment having this function is shown in Figure 11a, in which the volume filling device (10) is sheathed in the stomach wall, close to and at least partially above the patient's cardia (26) when the patient is standing. in the standing position, being secured in a position above the area of the cardia (26) by means of a fastening element, such as sutures or staples (14a). Thus, for example, a direct or indirect fixation to the diaphragm muscle or other muscle tissue can be provided. Alternatively, a direct or indirect fixation to the esophagus, above and close to the angle of His, can be provided. In this alternative embodiment, the volume filling device (10) rests in a position against the fundus stomach wall, when implanted, and which also fills a volume above the area of the cardia (26), between the cardia and the diaphragm muscle. , so that the cardia is prevented from slipping into the chest cavity, whereby reflux disease is prevented.

In this preferred embodiment, the reflux disease and obesity treatment apparatus comprises two or more segments of a movement restriction device adapted to form the movement restriction device (310). In this embodiment, there are a plurality of spherical motion restriction device segments, in the form of small spheres, which are contained in a motion restriction device segment in the form of an outer layer or shell, which is preferably elastic or flexible . Thereby, 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 59a-59c.

By providing a movement restriction device (310) with a plurality of movement restriction device segments, 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 pouch, previously created by part of the patient's stomach wall, without any external collection layer or shell. This mode 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 nearer part (310'), that part can be made of a different configuration from the farthest part (310”). Thus, in an embodiment shown in Fig. 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 more distant (310”) comprises a plurality of small segments of motion restriction devices. This modality combines the advantages of a stable closer part (310’), used to prevent backflow, with a more adaptable farther part (310”), used as a volume filling device for obesity treatment. Generally, the parts closer and farther can have different configurations and contents, independently of each other. Such content can be a mixture of solid and fluid content, such as friction increase or fluid reduction.

Such volume filling device (10) can be used for maintenance of electronic elements and/or power source and/or hydraulic fluid. The hydrogen fluid from this device can be distributed to several smaller areas of the inflatable device to vary the stretching area from time to time, avoiding any possible more permanent stretching effect on the stomach wall. Even by mechanical action, several stretching areas can be used.

In an alternative embodiment, as shown in Figure 12, the volume of an inflatable volume filling device (10) may 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 moving between the chambers.

Thus, the larger chamber (10) is adapted to, with the disposition of its main volume, constitute a volume filling device for reducing the size of the food cavity and for treating reflux disease, and one or several smaller chambers are adapted for function as inflatable devices for treating 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 still 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 stomach of the patient. Thus, an adjustable volume filling device (10) is shown in Figure 13, which is sheathed in the stomach wall (12) of a patient. 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 via a power supply line (56). The energy transforming 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 fluid tube (52).

The operation of this arrangement is as set out below. The volume of the volume filling device (10) works as in the modalities described above, i.e. it reduces the size of the food cavity of the patient's stomach (12). Furthermore, when the stretching device (50) is amplified by the pumping fluid of the volume filling device (10) and to the stretching device (50) by means of the pump (54), the bottom wall of the stomach is stretched, creating a feeling of satiety for the patient. Thus, for example, when food intake is detected via the sensor (19), fluid is automatically pumped into the stretching device (50) to increase the feeling of satiety and thereby limit food intake .

When fluid 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 fluid flow in the second tube (58), preferably narrower, of the stretching device (50) towards the volume filling device (10). The flow/flow velocity 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 the stretching device (50) return to equilibrium after three hours of the fluid having been injected into the stretching device (50), to create the feeling of satiety.

In this embodiment, the function of the second tube (58) is to allow 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) in the first tube (52), and that the second tube (58) can then be omitted.

Figure 14 illustrates an embodiment 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 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 first fluid tube (52) and a second fluid tube, which preferably has a cross-sectional 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 flow 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 unenergized. Instead, it operates according to the following principles.

When the food cavity of the stomach (12) is substantially emptied, there is a state of equilibrium between the internal pressure of the volume filling device (10) and the stretching device (50). In this state, the stretching device is in an unstretched state, that is, it does not stretch a part of the bottom wall of the stomach and thus does not create a feeling of fullness.

When the patient starts eating, the food will enter the food cavity of the stomach (12). This will create a pressure increase in the stomach wall in which the volume filling device (10) is sheathed, and the internal pressure in question will be increased. Also, the stomach wall muscles will begin to process the 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, in that it is located in the upper part of the stomach (12), where no food exerts pressure on the stomach wall, a Fluid flow will be created through the first and second fluid tubes (52), (58), towards the volume filling device (10) and the stretching device (50). This, in turn, will increase the volume of the stretching device (50), which, upon stretching the bottom wall of the stomach, will provide a feeling of fullness to the patient.

A flow of fluid from the stretching device (50) to the volume filling device (10), through the second tube (58), will return the pressure of these devices to equilibrium, as described above with reference to Figure 13.

Figure 15 illustrates an embodiment which is similar to that shown in figure 14, but with the addition of an injection port (16) which is used for refilling the fluid system comprising the volume filling device (10) and the stretching device (50) or, alternatively, to actively adjust the size of said system.

Similarly, Figure 16 illustrates an 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 Fig. 9 Thus, a regulating reservoir for fluid (17) is connected to the inflatable device by means of a conduit (18) in the form of a tube. Thereby, the stretching device (50) is adapted to be regulated, non-invasively, by moving liquid or air from the regulation reservoir (17) to the chamber formed by the inflatable device. The regulation of the stretching device (50) preferably comprises an inverse servo mechanism, i.e. 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) is shown in figures 17a and 17b, in which figure 17b shows a cross-sectional view of the stomach shown in figure 17a, along the line XVIIb - XVIIb. Thus, the volume filling device (10) is adapted to be placed within the stomach wall (12), such as through a gastroscopic instrument or similar intraluminal instrument, and bearing within the stomach wall (12a ). The inflatable device can be kept sheathed by means of sutures or staples (14), as in the embodiments of figures 2a and 2b. In this modality, no holes are required in the stomach wall. Rather, 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 hemming instrument.

The hemming instrument, generally designated (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 hemming instrument (630) further comprises a perforated suction portion (634), which preferably is elongated. The suction portion (634) exhibits a plurality of small holes (636), into which air will be sucked by providing suction in the tube element (632). This suction effect will be used to create a “pocket” or “pocket” in a part of a stomach wall, usually referenced 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) which forms the recess, due to the suction effect, will adhere to the suction portion (634) of the hemming 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 seen in figure 18d. The edge of the recess at this stage will be fixed by means of fasteners (638) and the suction portion will be removed from the instrument, as 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 said fixing elements, as seen in figure 18h.

All of the alternatives described above with reference to Figures 2-16 are also applicable to the modality described with reference to Figs. 17 and 18, i.e. the modality 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 shaped like 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 elongate element (650) which is adapted to be flexible by means of a construction comprising multiple elements in the form of a ring, however, it is also conceivable that said elongate element (650) is adapted to be flexible, wherein said elongate element (650) is made of a flexible or adjustable material. The elongated element (650) is inserted into the body and placed in proximity to the patient's stomach wall (12), from outside or inside said body. The elongated element (650) has a special support device (651) adapted to support the stomach by means of mechanical grasping or vacuum elements. The special support device (651) comprises a first gasket (652) and a second gasket (653), which enables the special support device (651) to be operable relative to the elongated element (650), thereby placing the part of the support device (651), which comprises the mechanical gripping elements or vacuum means, in contact with the stomach wall (12) of the patient. 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 when the step of advancing the push rod (654) from the elongated element (650) is performed. The push rod (654) pushes the stomach wall (12) to create a cavity or pouch therefrom. Figure 19d shows the instrument rotated 90° in relation to figures 19a-19c. This view shows the special support elements (651a, 651b) operatively fixed to both sides of the elongated element (650), and in contact with the stomach wall (12), supporting said stomach wall (12), when the rod booster (654) promotes pushing to create a cavity or pocket. When the push rod (654) has pushed the stomach wall (12) into a desired position, the special support devices (651a, 651b) move towards the push rod (654) and thereby close the 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 suturing or stapling device (655) from the elongated element (650). The suturing or stapling device (655) is positioned in connection with the stomach wall, after which the suturing or stapling device starts the procedure of suturing or stapling the stomach wall (12), creating a seal for the sutures. or stomach-to-stomach connecting staples (14). The instrument is moved along the patient's stomach wall (12) and thereby a cavity or pouch 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 insert (656) is advanced from the elongate element (650). Insertion element (656) is adapted to insert an inflatable volume filling device (10) as previously described herein. After the insert (656) has been positioned in the cavity or pouch, the volume filling device (10) is inserted through the insert (656) into the cavity or pouch, by means of a pressurized fluid or gas, or by means of a mechanical advancing element, pushing said inflatable volume filling device (10) into the cavity or pocket. The inserter then inflates the inflatable volume filling device with a fluid or gas, and seals the end section of the pouch using stomach-to-stomach connecting sutures or staples (14). The described embodiment explains the insertion process of an inflatable volume filling device, however, it is also conceivable that the volume filling device (10) can be expanded by means of the volume filling device (10) made of a material elastic.

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 shaped like 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 elongate element (660) which is adapted to be flexible by means of a construction comprising multiple elements in the form of a ring, however, it is also conceivable that said elongate element (660) is adapted to be flexible, wherein said elongate element (660) is made of a flexible or adjustable material. The elongated element (660) is inserted into the body and placed in proximity to the patient's stomach wall (12), from either outside or inside said body. The elongated element (660) has multiple special support devices (661) adapted to support the stomach by means of mechanical grasping 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 from one end of flexible material and pre-folded to expand into a funnel-shaped device when said locking ring (662) is removed. The special support device in its expandable funnel-shaped state is shown in figure 20b. Figure 20b further shows the special support device (661) when placed in contact with the stomach wall (12) of a 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) from the elongate element (660) is performed. The push rod (664) pushes the stomach wall (12) to create a cavity or pouch therefrom. When the push rod (664) has pushed the stomach wall (12) into a desired position, the special support devices (661) move towards the push rod (664) and thereby close said cavity. or said scholarship.

After the cavity or pouch has been created, they need to be sealed. Figure 20d shows the advancement of a suturing or stapling device (665) from the elongated element (660). The suturing or stapling device (665) is positioned in connection with the stomach wall, after which the suturing or stapling device (665) starts the procedure of suturing or stapling the stomach wall (12), creating a seal for the stomach-to-stomach connecting sutures or staples (14). After that, an insert element (666) is advanced from the elongated element (660), and the special support devices (661) are retracted. Insertion element (666) is adapted to insert an inflatable volume filling device (10) as previously described herein. After the insert (666) has been positioned in the cavity or pouch, the volume filling device (10) is inserted through the insert (666) into the cavity or pouch, by means of a pressurized fluid or gas, or by means of a mechanical advancing element, pushing said inflatable volume filling device (10) into the cavity or pocket. The insert (666) then inflates the inflatable volume filling device with a fluid or gas, and seals the end section of the pouch using stomach-to-stomach connecting sutures or staples (14). The described embodiment explains the insertion process of an inflatable volume filling device (10), however, 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 in the stomach wall (12), in a cavity or pouch sealed with sutures or staples connecting the 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 to a stomach wall (12). The instrument comprises an elongate element (670), which is adapted to be flexible by means of a construction comprising multiple elements in the form of a ring, however, it is also conceivable that said elongate element (670) is adapted to be flexible, wherein said elongate element (670) is made of a flexible or adjustable material. The elongated element (670) is inserted into the body and placed in proximity to the patient's stomach wall (12) from within said body. A stomach penetrating element (672) is placed at the distal end of the elongated element (670), retractably attached to a protective sleeve (673) adapted to protect the body tissue from the sharp penetrating element or cutter element ( 672), after the cutting operation has been performed.

Figure 21b shows the instrument comprising the elongated element (670), after the cutting operation has been performed, and the penetration element or stomach cutter 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 guide a duct (18) or a wire attached to the volume filling device (10) placed in the stomach from within. 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 embodiments. Directing the conduit (18) or electrical wire makes it possible to attach the conduit (18) or 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 power transforming device (1002) is adapted to supply power to power-consuming components of the apparatus through a power supply line (1003). An external power transmission device (1004) for non-invasively energizing the apparatus (10) transmits power via at least one wireless power signal. The deployed energy transforming device (1002) transforms energy from the wireless power 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 load sensor 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 may 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, an ultraviolet light signal, laser light signal, microwave signal, radio wave signal, X-ray radiation signal, and gamma radiation signal. Alternatively, the wireless power signal can include an electric or magnetic field or a combination of an electric and magnetic field.

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

Generally speaking, the energy transforming device (1002) is provided to transform wireless energy from a first form of energy, transmitted by the energy transmission device (1004), into a second form of energy, which typically , is different from the first form of energy. The implanted device (10) is operable in response to the second form of energy. The energy transforming device (1002) can directly drive the apparatus with the second form of energy, when the energy transforming device (1002) transforms the first form of energy, transmitted by the energy transmitting device (1004), into the second form of energy. The system may further include an implantable accumulator, where the second form of energy is used, at least partially, to charge the accumulator.

Alternatively, wireless power transmitted by the power transmission device (1004) can be used to directly drive the apparatus when wireless power is being transmitted by the power transmission device (1004). When the system comprises an operating device to operate the apparatus, as will be described below, the wireless energy transmitted by the power transmission device (1004) may be used to directly drive the operating device to create kinetic energy, so to promote the operation of the device.

The wireless energy of the first form of energy may comprise sound waves and the energy transforming device (1002) may include a piezoelectric element to transform the 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 apparatus.

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 form of energy and energy of the second form of energy 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 energy transmission device is controlled from outside the patient's body to release wireless non-magnetic energy, and the wireless non-magnetic energy released is used to operate the device.

The external power transmission device (1004) also includes a wireless remote control device having an external signal transmitter for transmitting 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 transforming device (1002) or be separate from it.

The wireless control signal can include a frequency, amplitude, or phase modulated 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 a magnetic field and an 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 signal, an 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 analogs.

Figure 23 illustrates the system shown in Figure 22, in the form of a more generalized block diagram, showing the apparatus (10), the energy transforming 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 as 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.

Figure 24 shows an embodiment of the invention, identical to the embodiment shown in Figure 23, except that an inversion device in the form of an electrical switch (1006), operable, for example, by polarized energy, is also implanted in the patient to invert the device (10). When the switch is operated by polarized power, the wireless remote control of the external power transmission device (1004) transmits a wireless signal that conducts polarized energy, and the deployed energy transforming device (1002) transforms the polarized energy. wirelessly in a polarized current to operate the electrical switch (1006). When the polarity of the current is changed by the implanted energy transforming device (1002), the electrical switch (1006) reverses the function performed by the apparatus (10).

Figure 25 shows an embodiment of the invention identical to the embodiment shown in Figure 23, except that an operating device (1007) implanted in the patient to operate the apparatus (10) is provided between the implanted energy transforming device (1002) and the apparatus (10). This operating device can take the form of a motor (1007), such as an electric servo motor. The motor (1007) is activated with power from the implanted energy transforming device (1002) when the remote control of the external energy transmission device (1004) transmits a wireless energy signal to the receiver of the transforming device. power deployed (1002).

Figure 26 shows an embodiment of the invention identical to the embodiment 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, i.e., 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 deployed energy transforming device (1002) transforms the wireless energy into a current, eg 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.

In all of these embodiments, the energy transforming device (1002) may include a rechargeable accumulator, such as a battery or a capacitor, to be charged by wireless power, for supplying power to any energy-consuming part of the system.

Alternatively, the wireless remote control device described above can be replaced by a manual control of any implanted part by making contact with the patient's hand, most likely indirect contact, eg 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 implanted energy transforming device (1002), further comprising a hydraulic fluid reservoir (1013), a motor/pump unit (1009) and an inversion device in the form of a hydraulic valve bypass device (1014), all implanted in the patient. Logically, the hydraulic operation can be easily performed, just by changing the pumping direction, so the hydraulic valve can then be omitted. The remote control can be a separate device from the external power transmission device or included with it. The motor of the motor/pump unit (1009) is an electric motor. In response to a wireless remote control signal from the external power transmission device (1004), the deployed energy transforming device (1002) activates the motor/pump unit (1009) with energy from the transported energy. 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) commands the hydraulic valve bypass device (1014) to shift the hydraulic fluid flow direction between a direction in which the fluid is pumped by the motor/pump unit (1009) from the hydraulic fluid reservoir (1013) to the apparatus (10), in order to operate the apparatus, and in another opposite direction, in which the fluid is pumped by the motor/pump unit (1009) back from the apparatus (10) to the hydraulic fluid reservoir (1013) so as to return the apparatus to a starting position.

Figure 28 shows an embodiment of the invention, comprising the external energy transmission device (1004) with its wireless remote control, the apparatus (10), the implanted energy transformation device (1002), an internal control unit implanted (1015), controlled by the wireless remote control of the external power transmission device (1004), an implanted accumulator (1016) and an implanted capacitor (1017). The internal control unit (1015) has the storage of electrical energy received from its energy transformation device implanted (1002) in the accumulator (1016), which supplies energy to the apparatus (10). In response to a wireless remote control control signal from the external power transmission device (1004), the internal control unit (1015) releases electrical energy from the accumulator (1016) and transfers the released energy through the power supply lines. energy (1018) and 1019), or directly transfers electrical energy from the deployed energy transformation device (1002), through a power supply line (1020), capacitor (1017) (which stabilizes the electrical current), power line power supply (1021) and power supply line (1019) for operating the apparatus (10).

The internal control unit is preferably programmable from outside the patient's body. In a preferred embodiment, the internal control unit is programmed to regulate the device (10), according to a previously defined time schedule or according to the input of information from 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 mode shown in Fig. 28 can be omitted. According to another alternative, the accumulator (1016) in this mode can be omitted.

Figure 29 shows an embodiment of the invention identical to the embodiment shown in figure 23, except that a battery (1022) for supplying power for operating the apparatus (10) and an electrical switch (1023) for switching the operation of the device (10), are also implanted in the patient. The electrical switch (1023) can be controlled by remote control and can also be operated by the power supplied by the implanted energy transforming device (1002), to switch to an off mode, in which the battery (1022) is not in use, to an on mode, in which the battery (1022) supplies power for operating the apparatus (10).

Figure 30 shows an embodiment of the invention identical to the embodiment shown in Figure 29, except that an internal control unit (1015), controllable by wireless remote control of the external power transmission device (1004) is also implanted in the patient. In that case, the electrical switch (1023) is operated by the power supplied by the implanted energy transforming device (1002), to switch in an off mode, in which the wireless remote control is prevented from commanding 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 ).

Figure 31 shows an embodiment of the invention identical to the embodiment shown in Figure 30, except that an accumulator (1016) is replaced by a battery (1022) and the implanted components are interconnected differently. In that case, the accumulator (1016) stores energy from the implanted energy transforming device (1002). In response to a wireless remote control control signal from the external power transmission device (1004), the internal control unit (1015) commands the electrical switch (1023) to switch in an off mode, in which the accumulator ( 1016) is not in use, for an on 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.

Figure 32 shows an embodiment of the invention identical to the embodiment shown in Figure 31, except that a battery (1022) is also implanted in the patient and the implanted components are interconnected differently. In response to a wireless remote control control signal from the external power transmission device (1004), the internal control unit (1015) commands the accumulator (1016) to release power to operate the electrical switch (1023) to switching from an off mode, 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 apparatus (10).

Alternatively, the electrical switch (1023) may be operated by power supplied by the accumulator (1016) to switch off mode, in which the wireless remote control is prevented from commanding the battery (1022) to supply electrical power and it is not in use, for a standby mode, in which the wireless remote control is allowed to command the battery (1022), to supply electrical energy for the operation of said apparatus (10).

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

Figure 33 shows an embodiment of the invention identical to the embodiment shown in Figure 29, except that a motor (1007), a mechanical reversing device in the form of a gearbox (1024), and an internal control unit (1015 ) to drive the gearbox (1024) are also implanted in the patient. The internal control unit (1015) commands the gearbox (1024) to reverse the operation performed by the apparatus (10) (mechanically 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 power to the operating device, in favor of a longer stroke actuation.

Figure 34 shows an embodiment of the invention identical to the embodiment shown in Figure 40, except that the implanted components are interconnected differently. Thus, in that case, the internal 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, energy for the operation of the apparatus (10).

Figure 35 shows, in schematic form, conceivable combinations of components implanted in the device, to obtain different communication options. Basically, the apparatus (10), the internal control unit (1015), the motor or pump unit (1009) and the external power transmission device (1004) including the wireless external remote control are shown. As already described above, the wireless remote control transmits a control signal which is received by the internal control unit (1015), which, in turn, controls the various components deployed in the apparatus.

A feedback device, preferably comprising a sensor or measuring device (1025), can be implanted in the patient to detect a physical parameter therefrom. The physical parameter can be at least one parameter selected from the group consisting of parameters of pressure, volume, diameter, stretch, stretch, extension, movement, bending, elasticity, muscle contraction, nerve impulse, body temperature, blood pressure, flow blood, heart rate 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, 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 may also include at least one parameter, selected from the group of parameters that consists of: electricity, any electrical parameter, pressure, volume, diameter, stretch, elongation, extension, movement, bending, elasticity, temperature and flow.

Feedback can be sent to the indoor control unit or out to an outdoor control unit, preferably via the indoor control unit. 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 apparatus (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 wireless external remote control. The wireless remote control may comprise a signal transmitter or transceiver and the indoor control unit (1015) may comprise a signal receiver or transceiver. Alternatively, the wireless remote control may comprise a signal receiver or transceiver and the indoor 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 apparatus (10) from inside the patient's body to the outside thereof.

When the motor/pump unit (1009) and the battery (1022) for driving the motor/pump unit (1009) are deployed, the information correlated to the charging of the battery (1022) can be fed back. To be more precise, when charging a battery or accumulator with energy, feedback information correlated to said charging process is sent and the energy supply is changed accordingly.

Figure 36 shows an alternative embodiment in which the device (10) is set 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, whereby the operation of the device (10) is switched between on and off modes. It should be noted that the modality shown is simplified and that additional components, such as an internal control unit or any other part disclosed herein, can be added to the system. Two 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, the performance is reversed.

Figure 37 shows an alternative embodiment, wherein the system (1000) comprises a hydraulic fluid reservoir (1013) hydraulically connected to the apparatus. A non-invasive adjustment 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 hydraulic fluid calibration.

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

Figure 38 schematically illustrates an arrangement of the system that is capable of sending information from inside the patient's body to the outside, providing feedback information correlated to at least one functional parameter of the apparatus or system, or information correlated to a physical parameter of the patient in order to supply a precise amount of energy to an implanted internal energy receiver (1002) connected to the energy consuming components implanted in the device (10). Such energy receiver (1002) may include an energy source and/or an energy transforming device. 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 apparatus (10), through a switch (1026). An energy balance is determined between the energy received by the internal energy receiver (1002) and the energy used by the apparatus (10), and 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 to properly operate the device (10), without causing an undue increase in its temperature.

In Figure 38, the patient's skin is indicated by a vertical line (1005). Here, the energy receiver comprises an energy transforming device (1002) located inside the patient, preferably just below the patient's skin (1015). Generally speaking, the implanted energy transforming device (1002) can be placed in the abdomen, chest, muscle fascia (eg, abdominal wall), subcutaneously, or in any other suitable location. The implanted energy transforming 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 skin. of the patient (1005), in the vicinity of the implanted energy transforming device (1002).

As is well known in the art, wireless energy (E) can generally be transferred via any suitable Transcutaneous Energy Transfer (TET) device, such as a device including a primary coil disposed at the external source of energy (1004a) and an adjacent secondary coil disposed in the implanted energy transforming device (1002). When an electrical 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 the incoming energy in an implanted power source, such as a rechargeable battery or a capacitor. However, the present invention is generally not limited to any specific energy transfer technique, nor to any TET devices or power sources, so any type of wireless power can be used.

The amount of energy received by the implanted energy receiver can be compared to the energy used by the components implanted in the device. The term "used energy" 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. In order to transfer 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 apparatus (10), somehow reflecting the required amount of energy necessary for proper operation of the device (10). Furthermore, 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, operating mode and temperature, as well as the patient's condition reflected by parameters such as body temperature , blood pressure, heart rate and breathing. Other types of patient physical parameters and device functional parameters are described elsewhere.

Furthermore, 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 further use. by the device (10). Alternatively or additionally, the characteristics of such a type of accumulator which 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 current state of the battery as well as any electrical parameter, eg energy consumption, voltage, temperature, etc. In order to provide sufficient voltage and current for the apparatus (10), and further to avoid excessive heating, it is clearly understood that the battery must be optimally charged upon receipt of a correct amount of energy from the energy transforming device implanted (1002), that is, an amount of energy not too small nor too large. The accumulator can also be a capacitor with corresponding characteristics.

Thus, for example, the characteristics of the battery can be measured regularly to determine the momentary status 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, consequently, be updated. In this way, the state of the battery can be “calibrated” 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 determination device is adapted to determine the energy balance and/or the amount of energy momentarily required (such as energy per unit of 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 energy source is used, or any combination thereof. The internal control unit (1015) is further connected to an internal signal transmitter (1027), arranged to transmit a control signal that reflects a certain required amount of energy, to an external signal receiver (1004c), connected to the unit. external control (1004b). The amount of power transmitted from the external power source (1004a) can then be regulated in response to the received control signal.

Alternatively, the determining device may include the external control unit (1004b). In this alternative, the sensor measurements can be transmitted directly to the external control unit (1004b), whereby the energy balance and/or the amount of energy momentarily needed can be determined by the external control unit (1004b), in this way , integrating the above-described function of the internal control unit (1015) into the external control unit (1004b). In that case, the internal control unit (1015) can be omitted and the sensor measurements are provided 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 presently required can then be determined by the external control unit (1004b) based on said sensor measurements.

Consequently, the present solution according to the arrangement of figure 38 uses the feedback of information indicating the energy required, which is more efficient than the previous solutions, because it is based on the actual use of energy compared to the energy received, by example, with respect to the amount of energy, the energy difference, or the speed of receiving energy, compared to the speed of energy used by the energy-consuming components deployed in the device. The device can use the received energy, either to consume or to store the energy in an implanted energy source or similar device. The different parameters discussed above can then be used, if important and necessary, and also as a tool for determining the actual energy balance. However, these parameters may also be needed 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 signals, infrared (IR) or ultrasonic signals. Alternatively, the internal signal transmitter (1027) and the external signal receiver (1004c) can be integrated in the implanted energy transforming device (1002) and external energy source (1004a), respectively, so as to drive the signals of control in a reverse direction relative to the transfer of energy, basically using the same transmission technique. Control signals can be modulated with respect to frequency, phase or amplitude.

Thus, feedback information can be transferred by 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 power receiver for receiving power wirelessly, the power receiver having a first internal coil and a first electronic circuit connected to the first coil, and an external power transmitter for transmitting power wirelessly, the power 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 power wirelessly, which is received by the first coil of the power receiver. This system further comprises 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 correlated to the loading of the first coil is received by the external power transmitter in the form of an impedance variation in the load of the second outer coil, when the power switch switches the connection from the first inner coil to the first electronic circuit, in an on and off mode. In implementing such a system, in the arrangement shown in Fig. 38, the switch (1026) is separate and controlled by the indoor control unit (1015), or integrated into the indoor control unit (1015). It should be understood that switch (1026) is to be interpreted in its broadest form. This means a transistor, MCU, MCPU, ASIC FPGA or converter (D/A), or any other component or electronic circuit that can switch power in an on and off mode.

To conclude, the power supply arrangement illustrated in Fig. 38 can basically operate in the following manner. The energy balance is first determined by the internal control unit (1015) of the determination device. A control signal reflecting the required amount of energy is also created by the indoor control unit (1015) and the control signal is transmitted from the indoor signal transmitter (1027) to the external signal receiver (1004c). Alternatively, the energy balance can be determined by the external control unit (1004b), rather than depending on the implementation as mentioned above. In this case, the control signal can drive 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 energy balance determined, for example, in response to the received control signal. This process can be repeated intermittently at certain intervals during the energy transfer progress, 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 various transmission parameters in the external power source (1004a), such as voltage, current, amplitude, wave frequency and pulse characteristics.

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 outer coil in relation to the inner coil and to optimize energy transfer , simply comparing, in this case, the amount of energy transferred with the amount of energy received. So, for example, if the outer coil is moved, the coupling factor may vary and correctly displayed movements may cause the outer coil to find an optimal location to transfer energy. Preferably, the external coil is adapted to calibrate the amount of energy transferred to obtain feedback information in the determining device before the coupling factor is maximized.

This coupling factor information can also be used as a feedback during energy transfer. In that case, the power system of the present invention comprises an internal implantable power receiver for receiving wireless power, the power receiver having a first internal coil and a first electronic circuit connected to the first coil, and an external power transmitter to transmit power wirelessly, the power 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 further comprises a feedback device for communicating the amount of energy received in the first coil as feedback information, and wherein the second electronic circuit includes a determination device for receiving the 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 power transmitter can regulate the transmitted power in response to the obtained coupling factor.

With reference to Fig. 39, although the wireless transfer of power to operate the apparatus has been described above, enabling non-invasive operation, it should be noted that the apparatus can also be operated with wired power. Such an example is shown in Figure 39, where 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 (1004b) commands the operation of the external switch (1026) to carry out the proper operation of the apparatus (10).

Figure 40 illustrates different modalities of how the received energy can be supplied and used by the apparatus (10). Similar to the example shown in Fig. 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 power receiver (1002) may comprise a constant voltage circuit, indicated by a dotted box "Constant V" in the figure, for supplying power at constant voltage to the apparatus (10). The internal power receiver (1002) may further comprise a constant current circuit, indicated by a dotted frame "constant C" in said figure, for supplying power under constant current to the apparatus (10).

The apparatus (10) comprises an energy-consuming part (10a), which can be a motor, 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 energy supplied from the internal energy receiver (1002). Thus, the supplied energy can be directly consumed by the energy consuming part or stored by the energy storage device, or the supplied energy can be partially consumed and partially stored. The apparatus (10) may further comprise an energy stabilization unit for stabilizing the energy supplied to the internal energy receiver (1002). Thus, energy can be supplied in a fluctuating 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 (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 power stabilization unit (1028) may comprise a constant voltage circuit and/or a constant current circuit.

It should be noted that Figure 38 and Figure 40 illustrate some possible but non-limiting implementation options regarding how the various components and functional elements shown can be arranged and connected to each other. However, one skilled in the art will readily appreciate that various variations and modifications can be made within the scope of the present invention.

Figure 41 schematically shows an energy balance measurement circuit of one of the proposed models of the system to control the wireless energy transmission or energy balance control system. The circuit has an output signal centered on 2.5 V, proportionally correlated to power imbalance. The derivative of this signal shows which value fluctuates up or down, and how fast that change occurs. If the amount of energy received is less than the energy used by the device's implanted components, more energy will be transferred and thus charged to the energy source. The output signal from the circuit is typically fed from an analog/digital (A/D) converter and converted to a digital format. The digital information can then be sent to the external energy transmission device, allowing it to adjust the level of 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 power 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 concept of energy balance and the way in which information is transmitted to the external energy transmitter can logically be implemented in numerous and different ways. The schematic figure 41 and the above-described method of evaluating and transmitting information should only be considered as examples of how to implement the control system.

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 this 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 energy balance output signal is present at the test point (Yl).

Those skilled in the art will imagine that the various modalities presented above of the system could be combined in several different ways. For example, the electrical switch (1006) of Figure 24 could be incorporated in any of the embodiments shown in Figures 27-33, the hydraulic valve diverter device (1014) of Figure 27 could be incorporated into 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 embodiments described in connection with Figures 38, 40 and 41 identify a method and system for controlling the transmission of wireless energy to the deployed energy consuming components of an electrically operable apparatus. This method and system will be defined in general terms below.

Therefore, a method of controlling the transmission of wireless power supplied to deployed power-consuming components of an apparatus as described above is provided. 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 , to 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. Wireless power transmission (E) from the external power source is then controlled based on the given power balance.

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

By controlling power transmission, the amount of wireless power transmitted can be decreased if the detected power balance modification implies that the power balance is increasing or vice versa. Power transmission decrease/increase may further correspond to a detected modification rate.

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

As mentioned above, energy used for operating 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.

When electrical and/or physical parameters of the medical device and/or physical parameters of the patient are determined, energy can be transmitted for consumption and storage, according to a transmission speed per unit of time, which is determined based on said parameters. The total amount of transmitted energy can also be determined 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 detected difference is correlated to the time integral of at least one measured electrical parameter correlated to the In 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 against the time of a measured electrical parameter, 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.

Wireless power transmission from the external power source can be controlled, by applying electrical pulses to the external power source, from a first electrical circuit for wireless power transmission, the electrical pulses having leading edges and trailing edges , varying the lengths of the first time intervals between successive leading edges and trailing 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 generated wireless energy from electrical pulses with a varied power, the power variation depending on the lengths of the first and second time intervals.

In this case, the frequency of electrical pulses can be substantially constant when varying the first and/or second time intervals. When applying electrical pulses, electrical pulses can remain unchanged, except when varying the first and/or second time intervals. The amplitude of electrical pulses can be substantially constant when varying the first and/or second time intervals. Furthermore, the electrical pulses can be varied, only varying the lengths of the first time intervals, between successive leading edges and trailing edges of the electrical pulses.

A sequence of two or more electrical pulses can be supplied in a row, so when applying the pulse sequence, the type where 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 sequences may be provided in a row, in which the lengths of the second time intervals between successive trailing edges of the second electrical pulse in a first pulse sequence and the leading edge of the first electrical pulse of a second sequence of pulses.

When applying electrical pulses, the electrical pulses can have a substantially constant current and a substantially constant voltage. Electric pulses can also have a substantially constant current and a substantially constant voltage. Furthermore, electrical pulses can also have a substantially constant frequency. Electrical pulses within a pulse sequence may also have a substantially constant frequency.

The circuit formed by the first electrical circuit and external energy source may have a first characteristic time period or a constant first time and, when the transmitted energy is actually varied, this time period frequency may occur in the range of the first characteristic time period either of constant time, or of a shorter time.

A system comprising an apparatus as described above is then provided to control the transmission of wireless energy provided to the deployed energy consuming components of said apparatus. In its broadest aspect, the system comprises a control device for controlling wireless power transmission from a power transmission device and an implantable built-in power receiver for receiving transmitted wireless power, the built-in power receiver being connected to the device's implanted energy-consuming components, to, directly or indirectly, supply the energy received to them. The system further 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 deployed in the apparatus, wherein the control device controls the transmission of energy wirelessly, from the external energy 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 apparatus (10) through a supply line. In one mode, the battery is not rechargeable. In an alternative embodiment, the battery is rechargeable. The battery supply, of course, can be arranged remotely or incorporated into the device.

Furthermore, the system may comprise any of the following items:- a primary coil in the external power source, adapted to transmit the power wirelessly inductively to a secondary coil in the internal power receiver; - the determining device is adapted to detect a change in the energy balance, and the control device commands wireless energy transmission, based on the detected energy balance change; - the determining device is adapted to detect a difference between the energy received by the internal energy receiver and the energy used for the implantable energy consuming components of the apparatus and the control device controls wireless energy transmission based on the detected energy difference; - the control device controls the external power transmission device to decrease the amount of wireless power transmitted, if the detected power balance modification implies that the power balance is increasing or vice versa, whereby the decrease/increase of power transmission corresponds at a detected modification speed;- the control device controls the external transmission device of power to decrease the amount of wireless power transmitted, if the difference in power detected implies that the power received is greater than the power used, or vice versa, whereby the decrease/increase in power transmission corresponds to the magnitude of said energy difference detected; - the energy used for the device is consumed to operate the device and/or stored in at least one energy storage device of the device; - when the electrical and/or physical parameters of the device and/or the parameters The patient's physical characteristics are determined, the energy transmission device transmits the energy for consumption and storage, according to a transmission rate per unit of time, which is determined by the determining device, based on said parameters. The determination device also determines the total amount of 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 detected difference is correlated to the integral with respect to time of at least one measured electrical parameter correlated to the energy balance, the determination device 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 determining 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 external coil with electrical pulses so as to transmit power wirelessly. Electrical pulses have leading edges and trailing edges, and the electrical circuit is adapted to vary the first time intervals between successive leading and trailing edges, and/or second time intervals between successive leading or trailing edges of the electrical pulses, to vary the power of wireless power transmitted. As a result, the energy receiver that receives the transmitted wireless energy has a varied 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 transmitted power 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 leading edges and trailing edges of the electrical pulses; - the electrical circuit is adapted for provide a sequence of two or more electrical pulses in a row, said sequence having a first electrical pulse at the beginning of the sequence of pulses and a second electrical pulse at the end of the pulse sequence; and the lengths of the second time intervals between successive trailing edges of the second electrical pulse in a first pulse sequence, and the leading edge of the first electrical pulse in a second pulse sequence, are varied by the first electronic circuit;- the electrical circuit is adapted to provide electrical pulses as pulses having a substantially constant height, and/or amplitude, and/or intensity, and/or voltage, and/or current, and/or frequency; - the electrical circuit has a constant time, being adapted to vary the first and second time slots only in the range of the constant first time, so that when the lengths of the first and/or second time slot are varied, the power transmitted over the first coil is varied; - 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 first constant time, or that is located relatively close to the first constant time, compared to the magnitude of the first time constant.

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

Figure 42 shows a system as described above. The system comprises an implanted apparatus (10) and further a separate regulating reservoir (1013), a one-way pump (1009) and a reciprocating valve (1014).

Figure 43 shows the apparatus (10) and a fluid reservoir (1013). When moving the regulation reservoir wall or modifying its size to any different one, the adjustment of the device can be carried out without any valve, just by simply passing fluid, at any time, through the movement of the reservoir wall.

Figure 44 shows the apparatus (10), a two-way pump (1009) and the regulation reservoir (1013).

Fig. 45 shows a block diagram of an inverse servo system, with a first closed system driving a second closed system. The servo system comprises a regulation reservoir (1013) and a servo reservoir (1050). The servo-reservoir (1050) mechanically controls an implanted device (10) through a mechanical interconnection (1054). The appliance has an expandable/contractable cavity. This cavity is preferably expanded or contracted by supplying hydraulic fluid from the larger adjustable reservoir (1052) in 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 form part of the apparatus itself.

In one embodiment, the regulation reservoir is placed subcutaneously under the patient's skin and is operated by pushing the outer surface of the patient with a finger. This system is illustrated in figures 46a-46c. In Fig. 46a, a flexible subcutaneous regulation reservoir (1013) is shown, connected to a domed-shaped servo reservoir (1050) by means of a conduit (1011). This servo-reservoir in domed or bellows format (1050) is comprised of a flexible apparatus (10). In the state shown in Fig. 46a, the servo reservoir (1050) contains a minimal amount of fluid and the largest amount of fluid is found in the regulating reservoir (1013). Due to the mechanical interconnection between the servo reservoir (1050) and the apparatus (10), the external shape of the apparatus (10) is contracted, i.e. 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 patient on whom the device is implanted, presses the regulation 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 its bellows shape, expands longitudinally. This expansion, in turn, expands the apparatus (10) so as to occupy its maximum volume, thereby stretching the stomach wall (not shown) which is placed in contact.

The regulation reservoir (1013) preferably is provided with a device (1013a) to maintain its shape after compression. This device, which is schematically shown 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 regulation reservoir essentially functions as an on and off switch switch 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 Fig. 47 comprises a first closed system which controls a second closed system. The first system comprises a regulation reservoir (1013) and a servo reservoir (1050). The servo reservoir (1050) mechanically controls a larger adjustable reservoir (1052) through a mechanical interlock (1054). An implanted apparatus (10) having an expandable/contractable cavity, in turn, is commanded by the largest adjustable reservoir (1052), by supplying hydraulic fluid from the largest adjustable reservoir (1052), in fluid connection with the apparatus (10) .

An example of this embodiment will now be described with reference to figures 48a-48c. As in the previous modality, the regulation reservoir is placed subcutaneously, under the patient's skin, being operated by pushing the external surface of the same through a finger. The regulation reservoir (1013) is in fluid connection with a bellows-shaped servo reservoir (1050) by means of a conduit (1011). In the first closed system (1013, 1011, 1050) shown in Fig. 48a, the servo reservoir (1050) contains a minimum amount of fluid and the greatest amount of fluid is found in the regulation reservoir (1013).

The servo reservoir (1050) is mechanically connected to a larger adjustable reservoir (1052), in this example also having a bellows shape, but with a larger diameter than the servo reservoir (1050). The largest adjustable reservoir (1052) is in fluid connection with the apparatus (10). This means that when a user pushes the regulation reservoir (1013), thereby displacing fluid from the regulation reservoir (1013) to the servo reservoir (1050), the expansion of the servo reservoir (1050) will displace a greater volume of fluid from the largest adjustable reservoir (1052) to the apparatus (10). In other words, in this inverse servo mechanism, a small volume in the regulation reservoir is compressed with a greater force and this creates a movement of a greater total area, with less force per unit area.

As in the previous embodiment described above with reference to Figs. 46a-46c, the regulating reservoir (1013) is preferably provided with a device (1013a) to maintain its shape after compression. This device, which is schematically shown 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 regulation reservoir essentially functions as an on and off type changeover switch for the system.

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 achieve the desired reduction in the food cavity. An example of this is illustrated in Fig. 49, where three ball-shaped volume filling devices (10) are sheathed in the stomach wall (12) of a patient.

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.

Fig. 50 shows an embodiment of an apparatus according to the invention. Figure 50 shows the segments of a volume filling device to be assembled prior to implantation into a patient in need of obesity treatment. The volume filling device segments include a core portion (560) and four outer portions (561a-561d). The generally cylindrical core portion is provided with an upper portion (560') and provided with four slots (562a-562d), which are symmetrically distributed and extend along the outer perimeter of the core portion. The outer parts (561a-561d) are shown generally as being 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 surface. internal. The flanges (563a-563d) are flush with the slits (562a-562d) in the illustrated embodiment, however, they may be arranged with loose fits between the flanges and the slits so that the mounted volume filling device is sufficiently installed in the its target implant position, above the cardia. If the volume filling device is inadvertently moved from its position into the stomach cavity, a loose fitting arrangement contributes to faster disassembly of its segments. The core part is connected to a guide wire (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 ), on the first outer 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 displaced towards the core part and the flange (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 outer part, now through the guide wire (564) through the second channel (566), connected to a corresponding channel in the flange (563b) of the second outer part (561b) . Figure 52 shows this performance again for mounting the third outside (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. Fig. 55 is a more detailed view of the core part, showing the channel system for the guide wire. Figures 55b to 55d represent cross-sectional views of 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 if the volume filling device accidentally becomes 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 easily pass through the gastrointestinal system if 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 portion and the segments is identical to that shown in figure 50, but the flanges (563a-563d) of the segments are provided with recesses (563'a-563'd), which are flush with the projection elements ( 562'a-562'd) of the slots (562a-562d) of the core part, thus, the movement restriction device becomes locked along different planes. In the present embodiment, these planes are arranged perpendicular to each other. Fig. 57 shows another embodiment of the volume filling device, according to Fig. 56, without the presence of any guide wire and without any features for the guide wire in the segments. This modality requires that locking elements of the leveling element be adapted to aid 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 portion 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 glove (600a ) having a diameter and cross-sectional shape to allow the passage of the core portion (560) and the four outer portions (561a-561d). A piston (602) is provided to move the volume filling device segments through the sleeve (600a) and into a certain space, where the volume filling device segments are to be mounted within the volume filling device or provide for the formation of such a device. As shown in Fig. 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 portion of the stomach wall (12) of a patient.

As shown in Fig. 58b, the guidewire (564) forces the outer parts (561a-561d) into 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 portion (560) are installed within a substantially spherical volume filling device (10). By 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 fully sheathed, as seen in Fig. 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 guidewire (564) has been decomposed. However, in case the volume filling device (10) becomes loose, due to any disruption of the sutures or staples (14), said volume filling device will collapse, so that the different segments, each of them being smaller than the assembled 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 plurality of relatively small 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 pouch is similar to that described with reference to figures 4a-4d, after a pouch has been created in the stomach wall. Thus, Figure 59 illustrates a portion of the stomach wall (12a), after sutures or staples (14) have been applied to create a pouch in the stomach wall. The pouch 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 pouch by means of a gastroscopic or laparoscopic tube-shaped instrument (600) such as the instrument illustrated in Figure 4b. The instrument comprises an outer glove and an inner glove (see figure 4b), which can be moved longitudinally in relation to the outer glove. The inner sleeve is provided with a cutting element in the form of a cutting edge (615) at the far end thereof. This cutting edge can be used to cut a hole in the stomach wall, as explained in more detail below.

When the instrument reaches a stomach wall, the inner glove is brought forward from its position in the outer glove, and contacts the stomach wall (12a). The cutting edge (615) of the inner sleeve then cuts a hole in the stomach wall so as to allow subsequent insertion of the volume filling devices (10) into that hole, as seen in Figure 59b. In order to push the volume filling device through the hole, a piston (602) can be provided in the instrument. Thus, the instrument further comprises a piston (602) adapted to drive 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 inner sleeve. , 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 phase-out process of the tube-shaped instrument (600), as seen in Fig. 59b, the pouch can be filled with the volume filling device segments (10) in a controlled manner.

After the pouch has been filled with segments of volume filling devices to a desired degree, as seen in Fig. 59c, the hole (12b) cut in the stomach wall (12a) by means of the tube-shaped instrument (600) is 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 displace the segments of volume filling devices (10) along the sleeve (600b). Alternatively, as shown in Fig. 59, the pressure exerted by the fluid can be used to propel or displace the segments of volume filling devices (10).

The volume filling device segments (10) can take many different shapes. In the embodiments shown in Figures 58a-58c and 59, they are substantially spherical. However, in alternative embodiments, 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, hexahedra, octahedra, dodecahedron or icosahedron, i.e. regular polyhedra with four, six, eight, twelve and twenty flat surfaces, respectively. These examples of segments of volume filling devices are shown in figures 61a-61e.

Volume filling devices can furthermore be maintained in a mutual relationship through additional measures. Thus, for example, the surfaces of the segments of volume filling devices may be provided with a friction-increasing agent or a material to minimize slippage of the segments of volume filling devices. The friction-increasing agent can be some type of glue or the like. Alternatively, or additionally, the surface or surfaces of the segments of volume filling devices may be provided with a rough texture, to increase friction between adjacent segments of volume filling devices.

As mentioned above, the volume filling device (10) can be inflated with a gel or fluid, supplied within a chamber, defined by the volume filling device (10), as seen in Figure 62. The insertion or injection of a plurality of volume filling device segments (10) within a natural pouch provided by a stomach wall portion (12), have been described above with reference to Figures 59a-59d. However, in an alternative embodiment of an obesity treatment apparatus, the volume filling device segments may also comprise a volume filling device segment for collecting two or more other volume filling device segments, which are of a different kind. Thus, the apparatus comprises a second expandable volume filling device segment (10) for collecting two or more first volume filling device segments (10) different from the second volume filling device segment, wherein , the second volume filling device segment and the first volume filling device segments when together form said volume filling device. It is preferred that the second segment of volume filling device is flexible or stretchable.

In an alternative embodiment, to allow remodeling of the volume filling device, a friction-reducing fluid may be provided to decrease friction between segments of adjacent volume filling devices. In Figure 64, it is shown how a plurality of segments of volume filling devices (10) are 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 volume filling device is sheathed in a stomach wall .

The embodiments of Figures 63 and 64 can be combined so that an outer segment of the volume filling device (10') includes a plurality of different segments of the volume filling device (10), in this case spherical, as well as, a fluid that reduces friction between different segments of volume filling devices.

The fluid described above may, instead of reducing friction between segments of adjacent volume filling devices, intensify friction between segments of adjacent volume filling devices, thereby making the "volume filling device more stable. The material The friction enhancer can also be a glue or an adhesive, i.e. a solidifying agent.

Segments of volume filling devices, adapted to be used as a plurality arrangement so as 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 volume filling device is implanted using a laparoscopic method, rather than the intraluminal method described above. According to this embodiment, 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 dissecting instrument is inserted, through one of said at least two laparoscopic trocars, and an area of the stomach is dissected. The volume filling device is then introduced into the abdominal cavity and placed outside the stomach wall. Then, a pouch is created in the stomach wall for the device, and the device is sheathed in said pouch by providing sutures or staples in 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 securing the device to the wall of the stomach, by provision of sutures or staples.

The above embodiment preferably further comprises providing an apparatus for setting the obesity treatment device from outside a patient's body; and operating said apparatus to set the obesity treatment device. Furthermore, 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 into said filling body.

According to one embodiment, the device is included or partially included in the pouch, whereby the pouch is left at least partially open. Additionally, the bag can be designed to display only one opening. Alternatively, the pouch is designed to display two openings and extend non-perimetrically around the stomach. Preferably, the pouch has a volume extension 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 described in the first alternative, but after dissection of the stomach, a hole is created in the stomach wall and a filling device. of volume is introduced into the abdominal cavity, through said hole, into the stomach. The device is placed within the stomach wall, and a pouch is created outside the stomach cavity to arrange the device placed within the stomach wall, and the device is sheathed in the pouch by providing sutures or staples in the wall of the stomach. 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 modality preferably further comprises attaching the device to the stomach wall by provision of sutures or staples. According to one modality, the stomach wall is fixed to the lower part of the patient's esophagus, through the provision of sutures or staples.

The second alternative presented above, preferably, further comprises the provision of an apparatus for setting the obesity treatment device from outside the patient's body; and operating said apparatus for regulating the obesity treatment device. Furthermore, 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 an injection volume of fluid within said filling body.

According to one embodiment, the device is included or partially included in the pouch, whereby the pouch is left at least partially open. Additionally, the bag can be designed to display only one opening. Alternatively, the pouch is designed to display two openings and extend non-perimetrically around the stomach. Preferably, the pouch has a volume extension of more than 15 mm.

A third alternative involves a surgical incision, rather than the intraluminal or laparoscopic method. Here, an opening is made in the patient's abdominal wall through a surgical incision, and an area of the patient's stomach is dissected. The volume filling device is introduced through 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 exceeds the volume of the volume filling device.

In an alternative modality to the above, namely the third alternative, the initial steps are the same, including the dissection of an area of the stomach. Thereafter, a pouch for the device is created in the stomach wall, whereby the device is sheathed in the pouch by providing sutures or staples in 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, the initial steps are the same, including 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 hole into the stomach. The device is then placed inside the stomach wall, and a pouch for the device is created in the stomach wall. The device is then sheathed in the pouch by providing sutures or staples in the stomach wall, thereby providing for 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 above-described modalities of the third alternative further comprise attaching the device to the stomach wall by providing sutures or staples.

The embodiment set forth above preferably further comprises providing an apparatus for setting the obesity treatment device from outside the patient's body; and operating said apparatus for regulating the obesity treatment device. Furthermore, 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 an injection volume of fluid within said filling body.

According to one embodiment, the device is included or partially included in the pouch, whereby the pouch is left at least partially open. Additionally, the bag can be designed to display only one opening. Alternatively, the pouch is designed to display two openings and extend non-perimetrically around the stomach. Preferably, the pouch has a volume extension of more than 15 mm.

A fourth alternative embodiment comprises a method including the steps of inserting an instrument in tube or needle form into the abdomen of a patient's body, using said tube or needle type instrument to fill the patient's abdomen with gas; place at least two laparoscopic trocars in the patient's body; inserting a camera through one of said at least two laparoscopic trocars into the patient's abdomen; inserting at least one dissecting instrument through one of said at least two laparoscopic trocars; dissect an area of the stomach; create a pouch from the stomach wall for the device; close the pouch by providing sutures or staples; introducing an injection element comprising an injectable filling material; and injecting the filling material into the pouch, thereby creating a filling body that fills a volume in the patient's stomach, reducing the cavity in size by a volume that substantially exceeds the volume of the volume filling device.

Instead of the laparoscopic method disclosed above, an incision or surgical opening is cut in the skin to enter the patient's abdomen; an area of the stomach is dissected; a pouch is created from the stomach wall for the device, and said pouch being closed by the provision of 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 food cavity in size by a volume that substantially exceeds the volume of the device. of volume filling.

In accordance with an alternative embodiment of the above, the pouch is created externally to the stomach wall, with the filling body being placed against the interior of the stomach wall.

The method according to either of the above two embodiments comprises creating a hole in the stomach wall, wherein a pouch is created inside the stomach wall, with the filling body being placed against the outside of the stomach wall.

The method according to either of the two previous modalities, may further comprise the fixation of the stomach wall in the lower part of the patient's esophagus, through the provision of sutures or staples, or the fixation of the stomach wall to the patient's diaphragm muscle or the other muscle tissue. Preferably, the bag has a volume extension of more than 15 mm.

In a method according to either of the above two embodiments, the filler material preferably is capable of undergoing a curing process, passing from a fluid state to a semi-solid or solid state. Preferably, said healing process is triggered by an increase in temperature from room temperature to body temperature.

The invention also makes available a method of treating obesity in a patient by implanting a volume filling device, which when implanted in the patient reduces the food cavity in size by a volume that substantially exceeds the volume of the filling device. volume, 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; place at least two laparoscopic trocars in the patient's body; place at least two laparoscopic trocars in the patient's body; inserting a camera through one of said at least two laparoscopic trocars into the patient's abdomen; inserting at least one dissecting instrument through one of said at least two laparoscopic trocars; dissect an area of the stomach; create a hole in the stomach wall; inserting a device into the abdominal cavity; insert the device through the hole into the stomach; placing the device externally to the stomach wall; affixing the externally placed device to the stomach wall, thereby creating a filling body which reduces the food cavity in size by a size that substantially exceeds the volume of the volume filling device.

In the method set out above, the device is preferably fixed 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 closer end and a distal end, the elongated element having a diameter smaller than that of the laparoscopic trocar, to be introduced into the patient's abdomen during a laparoscopic operation; a stomach booster device for pushing the stomach wall so as to create a tube-like shaped portion of the stomach wall which projects into the normal cavity of the stomach, said booster device comprising the volume filling device to be sheathed by the stomach wall in the tube-like shaped portion thereof; wherein the booster device comprises a vacuum device for sucking the bottom of the stomach to assist the instrument in forming the tube-like shaped portion of the stomach wall together with the booster device, and wherein the vacuum device comprises a vacuum passage going from the closest end to the far end of the instrument and at the terminal portion of the instrument, including the booster device, said vacuum passage being divided into multiple small openings, adapted to suck the stomach wall portion, to become adherent to the thrusting device, to further form the stomach tube-like wall portion; and further wherein the instrument comprises an inserter adapted to introduce the volume filling device into the tube-shaped shaped stomach portion.

Such an instrument preferably comprises at least one clamping device for holding the opening of the tube-shaped portion substantially closed by the joint stomach-to-stomach clamping in said opening, wherein the instrument is adapted to place said at least one device. of tightening in the opening, in a way that allows a posterior suturing of the opening.

Furthermore, preferably, the instrument comprises an inflation device, for inflating the volume filling device before or after the suturing procedure. Furthermore, preferably, the instrument comprises a suturing device, adapted to suture the opening of the tube-shaped portion with stomach-to-stomach connecting sutures, to create, at least partially, an enclosed space that includes the volume filling device. , wherein the instrument is adapted to be withdrawn, leaving the volume filling device at least partially sheathed in the stomach wall.

Said suture device preferably comprises a first and second suture positioning element, provided on the elongated element situated in the stomach, at the far end thereof, and wherein the instrument further comprises an operating device, adapted to adjust the first and second suture element, in a position where the positioning elements of the first and second suture element face the stomach wall, on both sides of the open end of the cup-like portion, and adapted to suture the end. open the cup-like portion of the wall with a row of stomach-to-stomach connecting sutures.

Preferably, the suturing device comprises a refillable operable multiple suture device, being refillable with sutures from 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. 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, for suturing two or more sutures simultaneously.

Thus, the invention comprises a method or method part, to be used in any combination and using any apparatus or apparatus part, or any feature in any combination, where the following method steps are applicable, said method may comprise one or more of the following operational steps: - introduce said instrument into the throat; - pass the instrument through the esophagus; - place an anvil or a unit to release fasteners 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 visualization when said instrument comprises a camera; - connect the instrument with the stomach; - create and suture at least one stomach wall bag; - fill said at least one bag 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 tissue of the stomach, through a tubular element; - passing through the stomach wall with said instrument; - pass through the stomach wall with said instrument, for placement of a volume filling device outside the stomach wall; - pass through the stomach wall with said instrument, to placement of a tube that allows placement of a subcutaneous injection port; - place a subcutaneous injection port; - suture or staple the stomach wall from its interior to the esophagus; - suture or staple the wall connection of stomach to the stomach wall, from the inside of the stomach; - connect the instrument to the esophagus; - suture or staple one layer of stomach tissue to one layer of esophagus tissue; - suture or staple two layers of stomach tissue to one layer of esophagus tissue; - suture or staple three layers from stomach tissue to one layer of esophageal tissue; - suture or staple four layers of stomach tissue to one layer of esophageal tissue; - suture or staple one or more layers of stomach tissue to two or more positions in stomach tissue; esophagus, the esophagus having a central axis of the esophagus, the esophagus further having a substantially cylindrical inner and outer surface that extends radially from the central axis of the esophagus, and wherein the stomach tissue is attached to the esophageal tissue at a first point along a first esophageal surface extension axis, substantially parallel to said esophageal central axis, and at a second point along a second esophageal surface extension axis, substantially parallel to said central axis of esophagus, at a distance from said first axis of esophageal surface extension, radially with respect to said central axis of esophagus;- 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 fasteners; - place said fasteners above the gastroesophageal junction to create an elongated passageway between the esophagus and the stomach, above of said junction; - place an esophageal part in the esophagus and a stomach part in the stomach; - place the fastening element substantially between the stomach and the esophagus 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 joint; - allow the elongated passage to contract substantially and unrestricted and freeing it from the sphincter muscle that closes the cardia placed at said junction, when such an elongated passage has been created.

The invention comprises a method or method part, to be used in any combination and using any apparatus or apparatus part, or any feature in any combination, where the following method steps are applicable, wherein said method comprises one or more of the following operational steps: - cutting a patient's skin; - creating an opening in the patient's abdominal wall; - introducing said instrument into the abdominal cavity, through said opening in the abdominal wall; - connecting the instrument with the stomach; - press down the instrument into the stomach wall so as to create at least one pre-molded stomach wall pouch; - staple the stomach wall to create at least one pre-molded pouch of stomach wall; - suturing or stapling at least one pouch to the stomach wall; - filling said at least one pouch with a fluid and/or a volume filling device, or two or more fluid filling devices. volume; - release 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 placing a volume filling device within the stomach wall; - passing through the stomach wall with said instrument, to suture the stomach wall to the esophageal wall; - placing a device - volume filling device outside the stomach wall; - sheathing said volume filling device in the stomach wall; - placing a subcutaneous injection port; - suturing or stapling 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;- suture or staple two layers of stomach wall to one or two layers of pair. stomach ede; - connect the instrument with the esophagus; - squeeze both sides of the esophagus, to secure a layer of esophageal wall to the stomach tissue; - squeeze both sides of the esophagus and the wall of the fundus of the stomach, to secure a layer of esophageal wall to one or two layers of stomach tissue; - introduce a tube or gastroscopic instrument into the esophagus, comprising an anvil element or a fixation release element, which engages in fixing the esophagus to the stomach; - coordinate the position of the element of an anvil or an attachment release element within the esophagus, in relation to said clamping instrument, around the esophagus; - suturing or stapling a layer of stomach tissue to one layer of esophageal tissue; - suturing or stapling two layers of stomach tissue to one layer of esophageal tissue; - suture or staple three layers of stomach tissue to one layer of esophageal tissue; - suture or staple four layers of stomach tissue to one the esophageal tissue layer; - promote stapling by using stapler elements of different stapling depths, in different positions, in a row of stapler elements; - staple the stomach to the esophagus with a first stapling depth and staple the stomach with stomach with a second smaller depth of stapling; - stapling a pouch with stomach-to-stomach connecting sutures in a row of stapling elements, further comprising stapling the esophagus with stapling elements of a greater depth, included as a part of said row of stapling elements; - suturing or stapling one or more layers of stomach tissue at two or more positions in the esophageal tissue, the esophagus having a central esophageal axis, the esophagus further having a substantially cylindrical inner and outer surface that extends radially from the axis central part of the esophagus, and in which the stomach tissue is attached to the esophageal tissue in a first point along a first esophageal surface extension axis, substantially parallel to said esophageal central axis, and at a second point along a second esophageal surface extension axis, substantially parallel to said esophagus central axis , at a distance from said first axis of esophageal surface extension, radially with respect to said central axis of esophagus; - release the fastening elements by means of a unit placed on said instrument; - penetrate into at least one layer of tissue of stomach and a layer of esophageal tissue with said fasteners; - place said fasteners above the gastroesophageal junction to create an elongated passage between the esophagus and stomach above said junction; - allow for elongated passage a substantially unrestricted contraction and releasing it from the sphincter muscle that closes the cardia placed at said junction, when such an elongated passage has been created; 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 fastening 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 to be inserted into the main cavity of the stomach , bending said joint in a certain direction, so as to reach a position of said part of the unit in the esophagus, above said joint.

The invention comprises a method or method part, to be used in any combination and using any apparatus or apparatus part, or any feature in any combination, where the following method steps are applicable, wherein said method comprises one or more of the following operational laparoscopic steps: - cutting a patient's skin; - introducing a tube through the abdominal wall; - filling the abdominal cavity with fluid or gas; - introducing two or more trocars into the abdominal cavity; - introducing a camera into the abdominal cavity through one of the trocars; - introduce said instrument into the abdominal cavity through one of the trocars; - connect the instrument with the stomach; - lower the instrument into the stomach wall to create at least one pre-molded stomach wall pouch; - squeeze the wall of stomach to create at least one pre-molded stomach wall pouch; - suturing or stapling at least one pouch to 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; - releasing a plurality of volume filling devices within said pouch created in the stomach tissue, through a tubular element; - passing through the stomach wall, into the stomach, with said instrument; - passing through the stomach wall with said instrument, for placing a volume filling device within the stomach wall; - passing through the stomach wall with said instrument. instrument, for suturing the stomach wall to the esophagus wall; - placing a volume filling device externally to the stomach wall; - sheathing said volume filling device in the stomach wall; - placing a subcutaneous injection port; - suturing or stapling the stomach wall with the stomach wall outside the stomach; - suturing or stapling two layers of the stomach wall to one or two layers of the stomach wall; - suturing or stapling the stomach wall with the stomach wall outside to the stomach, without penetrating the mucosa; - connect the instrument to the esophagus; - squeeze both sides of the esophagus to attach a layer of esophageal wall to the stomach tissue; - squeeze both sides of the esophagus and the bottom wall of the stomach to attach a layer of esophageal wall to one or two layers of stomach tissue; - introduce a gastroscopic tube or instrument into the esophagus, comprising an incus element or a fixation release element, which engages in fixation of the esophagus to the stomach; - coordinate the position of the incus element or a fixation release element within the esophagus, in relation to said clamping instrument, around the esophagus; - suturing or stapling a layer of stomach tissue to a layer of esophageal tissue; - suturing or stapling two layers of stomach tissue to a layer of tissue esophageal; - suturing or stapling three layers of stomach tissue to a layer of esophageal tissue; - suturing or stapling four layers of stomach tissue to a layer of esophageal tissue; - stapling by using stapler elements of different 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 stapl stomach with stomach with a second smaller depth of stapling; - stapling a pouch with stomach-to-stomach connecting sutures in a row of stapling elements, further comprising stapling the esophagus with stapling elements of greater depth, included as a part of said row of stapling elements; - suturing or stapling one or more layers of stomach tissue at two or more positions in the esophageal tissue, the esophagus having a central esophageal axis, the esophagus further having a substantially cylindrical inner and outer surface that extends radially relative to the central axis of the esophagus, and wherein 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 axis of the esophagus, and at a second point to the along a second axis of esophageal surface extension, substantially parallel to said central axis of esophagus, at a distance. taking said first axis of esophageal surface extension radially relative to said central axis of esophagus; - release the fasteners 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 fasteners; - place said fasteners above the gastroesophageal junction, to create an elongated passage between the esophagus and the stomach, above said junction; - allow the elongated passage to contract substantially unrestricted and release it from the sphincter muscle that closes the cardia placed at said junction, when such 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; - place the fastening 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 said unit above. of said joint; - 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 of said junction.

It should be noted that any modality or part of a modality, as well as any method or part of a method, or any apparatus or part of an apparatus, or any feature or part of a feature, or any system or part of a system, may be combined in a applicable way. 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 steps, change the order of steps and combine elements of different embodiments 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 modalities or features of a modality, as well as any method or step of a method can be combined in any mode, if such a combination is not clearly contradictory. Also, it should be noted that generally speaking, the description is to be seen as describing an apparatus and a device adapted to carry out a method, as well as that method itself.

Although specific embodiments of the invention have been described and illustrated herein, it can be imagined that numerous other embodiments may be sought and that numerous additional advantages, modifications and changes could easily occur to those skilled in the art, without departing from 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, various modifications may be made without departing from the spirit and scope of the general inventive concept as defined by the appended claims and their equivalent concepts. Therefore, it should be understood that the appended claims are intended to cover all such modifications and changes provided they fall within the true spirit and scope of the invention. Numerous other embodiments can be envisaged without departing from the spirit and scope of the present invention.

Claims (15)

1. Apparatus for treating obesity in a human or animal mammalian patient characterized in that it comprises:- two or more segments of a volume filling device, adapted to form an implantable volume filling device, wherein the 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 external surface of the device bearing against 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, when said volume filling device is sheathed in the stomach wall, and wherein said volume filling device volume filling is adapted to be disassembled into its volume filling device segments if the filling device of volume leaves its implanted and sheathed position in the stomach and inadvertently penetrates the stomach wall to become localized within the stomach, including penetration into the stomach wall to maintain a position within it. 2. Apparatus according to claim 1, characterized in that the segments of the volume filling device comprise first and second segments of the volume filling device, said second segment of the volume filling device being a second segment expandable of the volume filling device to include two or more first segments of the volume filling device, wherein the second segment of the volume filling device and the first segments of the volume filling device together form said device. of volume filling. 3. Apparatus according to claim 2, characterized in that at least one of: - said expandable segment of the volume filling device comprises a friction-reducing material on its inner surface, the friction-reducing material if available in contact with the first segments of the volume filling device, when it is implanted, and said second segment of the volume filling device is adapted to be filled with a fluid, to allow a mutual movement between the first segments of the volume filling device placed in the expandable segment 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 wall of stomach. 4. Apparatus according to claim 2 or 3, characterized in that:- at least a wall portion of said second segment of the volume filling device is flexible; - at least a wall portion of said second segment of the volume filling device is stretchable. 5. Apparatus according to any one of claims 2 to 4, characterized in that the volume filling device further comprises an expandable structure, wherein said structure comprises a bellows-like element adapted to take into account fibrosis that wraps the device when implanted. 6. Apparatus according to any one of claims 1 to 5, characterized in that at least one of the segments of the volume filling device has at least one flat surface or the shape of a polyhedron. 7. Apparatus according to any one of claims 1 to 6, characterized in that the volume filling device has a maximum perimeter of at least 30 millimeters. 8. Apparatus according to any one of claims 1 to 7, characterized in that it further comprises a support device, adapted to be held by an instrument and to simplify the implantation of the device. 9. Apparatus according to any one of claims 1 to 7, characterized in that it comprises a fixation device, adapted to fix the volume filling device or its segments to the stomach wall, in order to maintain the device volume filling device in place when said volume filling device is implanted. 10. Apparatus according to any one of claims 1 to 9, characterized in that the volume filling device or at least one of its segments is inflatable. 11. Apparatus according to any one of claims 1 to 9, characterized in that the volume filling device or at least one of its segments is expandable. 12. Apparatus according to claim 9, characterized in that the volume filling device or at least one of its segments comprises an inflatable chamber, further comprising at least one tube connected to the device, for supplying fluid to the chamber . 13. Apparatus according to claim 12, characterized in that it further comprises an injection port that can be connected to the tube. 14. Apparatus according to any one of claims 9, 12 or 13, characterized in that the volume filling device and/or at least one of its segments is adapted to be non-invasively adjustable after the operation. 15. Apparatus according to any one of claims 9 and 12 to 14, characterized in that the volume filling device further comprises an external control unit to control the volume filling device from outside the patient's body .

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