JP2012516196A5 - - Google Patents

Description

Obesity treatment

  The present invention relates to devices, systems and methods for treating obesity.

  Obesity has been treated by strangulation of the stomach, ie by placing a band around the stomach, creating an artificial or restricted opening, and restricting the flow of food below the band . Attempts have also been made to use electrical stimulation to the stomach wall to make the patient feel full.

  As the stomach swells, the patient feels like the stomach is full.

  Another prior art method of treating obesity is to insert a balloon-like object into the patient's stomach. In this way, the patient feels full satisfactorily when eating, thereby preventing excessive food intake. However, these prior art balloon-like objects are exposed to gastric acid and will be destroyed after use within 2 months.

  An example of an inflatable gastric device for obesity treatment according to the prior art is disclosed in US Pat. This document discloses an abdominal method in which an inflatable balloon is surgically implanted in the abdominal cavity adjacent to the patient's stomach. An adjustment port is provided under the skin, followed by inflating the balloon by inserting a hypodermic needle through the patient's skin into the adjustment port and introducing fluid under pressure into the port and through the balloon, thereby Inflates the upper abdomen, compresses the stomach and creates a feeling of fullness.

U.S. Pat. No. 4,246,893

  It is an object of the present invention to provide an obesity treatment device, system and method with improved properties for long-term use.

  This and other objects are achieved by the apparatus described in the appended claims. In broad terms, the present invention relates to an apparatus for treating obesity in a human or animal mammalian patient, the apparatus preferably adapted to form an implantable volume filling device of controlled size. One or more volume filling device segments are provided. The volume filling device is adapted to be at least substantially invaginated by the stomach wall portion of the patient, wherein the volume filling device is adapted to allow the outer surface of the device to rest relative to the stomach wall. Thus, when the volume filling device is invaginated into the stomach wall, the size of the volume of the food cavity is reduced by a volume substantially exceeding the volume of the volume filling device. The volume filling device has been placed in the stomach, inadvertently piercing the stomach wall, away from its position relative to the stomach where the device is implanted and invaginated (the position in the stomach by piercing the stomach wall) The volume filling device segment, wherein the volume filling device segment separately passes through the gastrointestinal tract and is obstructed / obstructed in the intestine of the patient. Is adapted to reduce the risk of causing Preferably, the volume filling device has a maximum perimeter of at least 15 millimeters, more preferably at least 30 millimeters. Preferably, the volume filling device segment has at least partially an outer surface comprising a biocompatible material. By causing the volume filling device to be invaded by the stomach wall on the outside thereof, the device is protected from gastric acid and can therefore remain functional for a very long time.

  According to one alternative, the volume filling device is adapted to be placed in the stomach such that the outer surface of the volume filling device rests against the inside of the stomach wall, so that The volume of the food cavity volume is reduced by a volume that exceeds the volume. Preferably, the volume filling device is adapted to be placed in the stomach using a gastroscope.

  According to another alternative, the volume filling device is adapted to be placed outside the stomach such that the outer surface of the volume filling device rests against the outside of the stomach wall, thereby The volume of the food cavity volume is reduced by a volume that substantially exceeds the volume. Preferably, the volume filling device is adapted to be completely invaginated by the patient's stomach and to be placed outside the stomach wall by an endoscopic instrument.

  For this purpose, the volume filling device segment may comprise an attachment device adapted to cooperate with the gripping equipment. Suitably the volume filling device is adapted to be non-invasively adjustable after surgery.

  Preferably, the volume filling device is segmented when it has moved away from being placed on the outer surface of the device resting against the stomach wall, i.e. implanted in an at least partially indented position. Adapted to disassemble into. Preferably, the segments are individually adapted to pass through the gastrointestinal tract and reduce the risk of causing obstruction / intestinal obstruction in the patient's intestine. The volume filling device segment can be adapted to pass through the trocar for assembling and implanting the volume filling device in the abdominal cavity. The volume filling device segment can have a flexible profile adapted to pass through the trocar. The volume filling device segment can be adapted to have a shape that can be assembled or formed as a volume filling device upon implantation. In certain embodiments, at least one of the volume filling device segments has a flexible outer surface. In one embodiment, at least one of the volume filling device segments comprises a rigid outer surface. In one embodiment, at least one of the volume filling device segments has a flexible outer surface and is hollow. In one embodiment, at least one of the volume filling device segments comprises a sealing wall that defines a chamber. At least one of the volume filling device segments can be adapted to be filled with at least one of a fluid, foam, gel or fluid that hardens to a solid material. In one embodiment, the volume filling device segment comprises a homogeneous and / or solid material, such as a solid body. In one embodiment, at least one of the segments includes a flexible and inelastic material. In one embodiment, at least one of the segments comprises an inflatable chamber and at least one tube connected to the chamber for supplying fluid to the chamber. The volume filling device segment is preferably adapted to temporarily hold its assembly position, preferably by an invaginated stomach wall, or alternatively by an adhesive.

  For assembly, the volume filling device is provided with at least one assembly element that fits well with at least one assembly element of another segment, and the assembly of the assembly element allows the segment to be assembled and implanted Volume filling device. Preferably, the segment for this purpose comprises a core part and a plurality of external parts, preferably the at least one assembly element is selected from a well-fitting flange and slit. The core part is adapted to receive and assemble the external part into an implantable volume filling device, and preferably the core part receives a corresponding assembly flange of the external part when the volume filling device is assembled. Has an adapted assembly slit. In one embodiment, the slits are distributed in the outer peripheral region of the core part. The external component is provided with a flange that sufficiently engages the slit, thereby assembling the device. In another embodiment, the at least one assembly element secures each of the volume filling device segments to the core part along a first plane, wherein the volume filling device segment and the core part are further in a second assembly. The second assembly element secures each segment and core component along a second plane having an angle with respect to the first plane following assembly of the segment and core component. . For example, the first plane and the second plane can be substantially vertical. The second assembly element comprises a joining element, preferably the joining element engages a protrusion and a recess provided in the volume filling device segment and the core part, and the at least one assembly element is a protrusion and A recess is further provided. Preferably, the at least one assembly element comprises an assembly slit in the core part and an assembly flange in the segment, wherein the joining element comprises a protrusion for the slit and a recess for the flange; or alternatively, at least One assembly element comprises an assembly flange in the core part and an assembly slit in the segment, wherein the joining element comprises a protrusion for the slit and a recess for the flange.

  In one particular embodiment, preferably the apparatus further comprises a guide device operable to assemble the volume filling device segment into an implantable volume filling device. Preferably, the guide device is an operating wire operably connected to the segment.

  The manipulation wire can be made of a biodegradable material that contacts bodily fluids in the abdominal cavity and facilitates the volume filling device to break down into segments. To assist in the assembly procedure, each segment can be provided with at least one assembly element that fits well with at least one assembly element of another segment, thereby fitting the assembly element The segments can be assembled into an implantable volume filling device. In one embodiment, the segment comprises a core part and a plurality of external parts, and in one embodiment, the assembly element is selected from a well-fitting flange and slit. Preferably, the core part is adapted to receive and assemble an external part into an implantable volume filling device. In one embodiment, preferably the core part has an assembly slit adapted to receive a corresponding assembly flange of the external part when the volume filling device is assembled. Preferably, the slits are dispersed in the outer peripheral region of the core part. The slits and flanges may be designed to fit loosely, which keeps the segments together as a volume filling device when the volume filling device is implanted and placed, while the device does not It is also carefully adapted to help disassemble the device if it has left this position, for example if it has moved to the stomach cavity. In such cases, the destruction of the guide device also helps the volume filling device to be disassembled into segments, which are designed not to cause any obstruction or damage to the patient in any form.

  In order to assemble the segment, the operation wire is connected to the core part and the external part, and the external part is sequentially assembled to the core part to assemble the volume filling device. For this purpose, preferably an operating wire is connected to the assembly flange of the external part, preferably the core part is provided with at least one operating channel for receiving the operating wire. Preferably, each external component is connected to two operating channels using operating wires. In one embodiment, the first operating channel has a first orifice at the end face of the core part and a second orifice in the first slit of the core part, whereby the first operating channel. When the operation wire received by the channel is displaced in the direction from the end face, the first external component is assembled to the core component. The second operation channel has two orifices in the second slit of the core part, so that when the operation wire connected to the first operation channel is displaced in the direction from the end face, the second external channel A part is assembled to the core part. Preferably, the guide wire protrudes from the orifice of the first channel so that it can be manipulated by an instrument for displacing the guide wire and the first external part, thereby providing an assembly flange. Assembles an implantable volume filling device by mating with the first assembly slit of its intended core element and displacing the remaining external parts in a similar manner in a predetermined sequence Can do. The segment can comprise more than two external parts, which are slits of the target core part by a guide wire passing through an operating channel having an orifice in each slit of the target core part. Assembled to. In one embodiment, the volume filling device comprises one core part and four external parts. However, other methods of designing the segments within the scope of the inventive concept can be performed by those skilled in the art. The volume filling device thus assembled can generally retain a spherical shape, but as described below, other shapes and additional functional elements are made as part of the present invention.

  The apparatus may comprise a fixation device, suitably two or more fixation devices adapted to involve the fixation of the volume filling device to the stomach wall. A volume filling device comprising at least one segment may comprise a holding device, suitably two or more holding devices, adapted to be held with the instrument to simplify the implementation of the device.

  At least a portion of the volume filling device may be made of a material that is not destroyed by stomach acid. The volume filling device may be one that is broken with an acid such as hydrochloric acid.

  In certain embodiments, a volume filling device including at least one segment is inflatable to an inflated state and comprises a sealing wall defining a chamber, the volume filling device being inflated by a gel or fluid supplied to the chamber. It is done. At least one tube may be connected to a volume filling device to supply gel or fluid to the chamber. An injection port connectable to the tube may be provided. Alternatively, the volume filling member may be provided with an injection port for fluid or gel that is connectable to the endoscopic instrument, the injection port adapted to interconnect the expandable device and the endoscopic instrument Provided with a fluid connection.

  The volume filling device may comprise a homogeneous material such as a gel having a Shore hardness of less than 15. The device may also be a solid body.

  A volume filling device that includes at least one segment may include a rigid, elastic, or flexible outer surface. When the outer surface is rigid, the outer surface is sufficiently rigid that it does not deform when subjected to forces generated by stomach movements. The volume filling device may comprise a flexible and inelastic material.

  According to a first general design of a volume filling device, this device has a maximum circumference when viewed in a plane perpendicular to the axis through the device. The outer circumference of the device viewed in another plane perpendicular to the axis is equal to this maximum outer circumference or decreases when viewed in the direction from the maximum outer circumference along the axis. For example, the device may be substantially oval, spherical, or substantially shaped into an egg-like shape with a recessed center or a distorted egg-like shape.

  According to a second general design of the device, the outer circumference of the device, viewed in a plane perpendicular to the axis through the device, increases or decreases at least twice when this plane is displaced along said axis, or this plane Displacement along the axis decreases and increases at least 1 fold. For example, the device may be shaped into a substantially kidney-like shape.

  The volume filling device in yet another embodiment has an outer periphery viewed in a plane perpendicular to an axis through the body, the outer periphery being intermediate from the first end of the axis along the axis. When moving to a point, it constantly increases or remains constant up to the maximum value, and when moving this plane from the intermediate point to the second end of the axis, it decreases constantly or remains constant. is there.

  In yet another embodiment, the volume filling device has an outer periphery viewed in a plane perpendicular to an axis through the body, the outer periphery extending from the first end of the axis along the axis. When moving to one intermediate point, it increases or remains constant up to the first maximum value, and when moving this plane from the first intermediate point to the second intermediate point, the first Steadily decreasing to a minimum value or remaining constant and increasing to a second maximum value when moving this plane from the second intermediate point to the third intermediate point of the axis, or It remains constant and either decreases constantly or remains constant when moving this plane from the third intermediate point to the second end.

  Further embodiments are described below.

  One or more of the volume filling devices and / or volume filling device segments may have an elongated, rounded, bent and / or curved shape.

  The volume filling device has an outer circumference of at least 30, 50, 80, 120, 150, 180 or 220 mm.

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

  The volume filling device may comprise at least two interconnectable parts adapted to be placed in the stomach as separate parts.

  The volume filling device comprising at least one segment may comprise an elastic material, a biocompatible material and / or silicone.

  Suitably, the volume filling device is provided with at least one layer. For example, a metal layer, a parylene layer, a polytetrafluoroethylene layer, or a polyurethane layer. The layers may comprise a plurality of layers in any order. Suitably one of these layers is made of metal, silicon or PIFE. The volume filling device may comprise an outer layer of silicone, polyurethane, Teflon, or polytetrafluoroethylene, metal, parylene, PIFE, or combinations thereof. The volume filling device may comprise an inner surface layer made of silicone, polyurethane, Teflon, or polytetrafluoroethylene, metal, parylene, PIFE, or combinations thereof. Other combinations include an inner layer of polytetrafluoroethylene and an outer layer of silicone, an inner layer of polytetrafluoroethylene and an intermediate layer of silicone and an outer layer of parylene, an inner layer of polyurethane and an outer layer of silicone, and an inner layer of polyurethane Includes an interlayer of silicone and an outer layer of parylene.

  A volume filling device that includes at least one segment may include a fluid adapted to transform into a solid state or a fixed shape. Such fluid may be liquid polyurethane or isotonic liquid. The fluid may contain large molecules such as iodine molecules to prevent diffusion.

  The volume filling device may have a maximum circumference of at least 50 millimeters, preferably at least 80 millimeters. Suitably, the volume filling device is deformable 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 suturing or stapling the stomach wall and stomach wall to cause the device to be invaginated into the stomach wall. Advantageously, the volume filling device has a variable circumference so that it can be invaded into the stomach wall of the patient and better held in place. Stomach or stomach wall suturing or stapling presents a structure adapted to contact the stomach wall to promote the growth of human tissue so that a volume filling device attached to the stomach wall can be reliably positioned for an extended period of time. A fixed part may be provided. This structure may include a net-like structure.

  In certain embodiments of the invention, the apparatus comprises a traction device positioned outside the stomach wall and adapted to retract a portion of the stomach wall to affect the patient's appetite. If the volume filling device comprising at least one segment is inflatable, the apparatus may comprise a fluid connection that interconnects the traction device and the volume filling device.

  In certain embodiments, the apparatus is implantable in an obese patient and is adapted to pull a portion of the patient's stomach wall and implanting the traction device to retract the stomach wall. An operation device for operating the traction device when generating a feeling of fullness is provided.

  In certain embodiments, the apparatus comprises at least one steerable traction device that is implantable in an obese patient and adapted to pull a portion of the stomach wall of the patient, and an implantable control unit. The device automatically manipulates the traction device in relation to the patient's feeding when the operating device and control unit are implanted to pull the stomach wall to create a feeling of fullness.

  In certain embodiments, the apparatus comprises at least one operable traction device that is implantable in an obese patient and adapted to pull a portion of the patient's stomach wall, the traction device comprising an inflatable traction reservoir. And the apparatus comprises an operating device for manipulating the traction device when implanting the traction device to pull a portion of the stomach wall to create a feeling of fullness, wherein the volume filling device Is inflatable and in fluid connection with the traction reservoir, the operating device injects fluid between the main reservoir and the traction reservoir to pull a portion of the stomach wall and A pump for generating A control device may be provided to control the traction device including the pump. The control device may comprise a wireless remote control adapted to control the traction device from outside the patient's body, or an implantable control unit for controlling the traction device. Alternatively, the control device may comprise a subcutaneously placed switch or reservoir adapted to control the traction device from outside the patient's body. A sensor or sensing device may be provided that is implanted in the patient's body, and the implantable control unit utilizes information from the sensor or sensing device adapted to sense patient feeding directly or indirectly And adapted to control the traction device from within the patient's body.

  In certain embodiments, a volume filling device comprises a main volume filling reservoir and a traction device that includes an at least one operable traction device that is implantable in an obese patient and adapted to pull a portion of the stomach wall of the patient. The traction device comprises an inflatable reservoir adapted to invaginate the stomach wall at the top of the stomach, which is higher than the inflatable main volume filling device when the patient is standing; The filling device is inflatable and is in fluid communication with the traction reservoir so that fluid can be drawn from the invaginated main volume filling reservoir located at a low position on the stomach wall by normal contraction of the stomach wall by feeding. Outflow and adapted to cause the traction reservoir to retract the stomach wall portion to create a feeling of fullness. The fluid connection between the main volume filling device reservoir and the traction reservoir comprises a check valve. The fluid connection between the main volume filling device reservoir and the traction reservoir comprises a release function adapted to release the volume of the traction reservoir back to the main volume filling device reservoir. The release function may comprise a reverse fluid connection that is substantially smaller than the fluid connection, which slowly returns fluid from a traction reservoir to the main volume filling device reservoir to release the traction of the stomach wall portion. To do. A manual control device may be further provided with a reservoir placed subcutaneously and adapted to control the traction device from outside the patient's body, thereby further affecting the traction device for traction of the stomach wall portion.

  In certain embodiments, a primary volume filling device reservoir adapted to be inflatable may be provided, the volume filling device further comprising an inflatable structure adapted to expand when the device is invaginated into the stomach wall, The structure includes a bellows adapted to account for fibrosis surrounding the device during implantation, such that the movement of the bellows is substantially unaffected by the fibrosis.

  In certain embodiments, the apparatus comprises a traction device that is implantable into an obese patient and includes at least one operable traction device adapted to pull a portion of the patient's stomach wall, the traction device comprising: With an inflatable structure adapted to inflate and pull the stomach wall portion when invaginated into the stomach wall, the structure comprising a special bellows adapted to account for fibrosis surrounding the device during implantation The bellows movement is substantially unaffected by the fibrosis. An operating device for operating the traction device may be provided to pull the stomach wall portion to create a feeling of fullness. The apparatus includes an implantable control unit that automatically associates the traction device with the patient's feeding when the control unit and the traction device are implanted to pull the stomach wall to produce a feeling of fullness. Control.

  In certain embodiments, the apparatus comprises a traction device including at least one operable traction device that is implantable in an obese patient and adapted to pull a portion of the patient's stomach wall to create a feeling of fullness. The control device may comprise a wireless remote control adapted to control the traction device from outside the patient's body, or an implantable control unit for controlling the traction device. Alternatively, the control device may comprise a subcutaneously placed switch or reservoir adapted to control the traction device from outside the patient's body. A sensor or sensing device may be provided that is implanted in the patient's body, and the implantable control unit utilizes information from the sensor or sensing device adapted to sense patient feeding directly or indirectly And adapted to control the traction device from within the patient's body.

  In certain embodiments, the apparatus further comprises a traction device comprising three or more mechanical parts that engage one by one with different parts of the stomach wall, said engagement being sutured or stapled to the stomach wall or with the stomach wall. Three or more mechanical parts are adapted to move relative to each other and to pull three different parts of the stomach wall, including intruding the mechanical part into the gastric wall part by suturing between the gastric walls; The device is further adapted to pull the portions of the stomach wall independently of each other, taking into account the force used to pull the stomach wall portion, the duration of the traction, and when to pull.

  In certain embodiments, the device comprises two or more hydraulic components that engage one by one with different parts of the stomach wall, the engagement being sutured or stapled to the stomach wall or suture between the stomach wall and the stomach wall. The two or more hydraulic parts are adapted to move relative to each other and to pull three different parts of the stomach wall, the traction device further comprising a gastric wall part. The gastric wall portions are adapted to be pulled independently of each other, taking into account the force used to pull the tract, the duration of traction and when to traction.

  In certain embodiments, the apparatus further comprises a traction device that engages a portion of the stomach wall, and the traction device is folded into the stomach wall portion by suturing or stapling the traction device to the stomach wall or by suturing between the stomach wall and the stomach wall. The traction device is further adapted to retract the portion of the stomach wall while controlling the force used to retract the stomach wall portion, the duration of traction, and when traction is performed.

  In certain embodiments, the apparatus further comprises a traction device comprising two parts that engage one another with different parts of the stomach wall, the engagement being a suture or staple to the stomach wall or between the stomach wall and the stomach wall. Including pulling the mechanical part into the stomach wall by suturing, wherein the traction device further controls the force used to pull the stomach wall portion, the duration of the traction, and when the traction is performed. Are adapted to be pulled independently of each other.

  In certain embodiments, the device is further adapted to treat reflux disease. For this purpose, the apparatus further comprises an implantable volume filling device adapted to be at least partially invaginated by the stomach wall at the bottom of the patient's stomach and having an outer surface comprising a biocompatible material. Most of the outer surface of the filling device is placed against the stomach wall at a location between the patient's diaphragm and at least a portion of the lower stomach wall below the invaded stomach without damaging the stomach wall. This limits the movement of the cardinal notch of the patient's stomach in the direction of the patient's diaphragm when the volume filling device is invaded, and the cardia passes through the opening of the patient's diaphragm. Thus preventing the patient's abdomen from supporting sliding against the patient's cardia sphincter and the volume filling device is at least as small as 125 mm3. Even with the outer periphery of the 15mm.

  In another embodiment, the device is further adapted to treat reflux disease. For this purpose, the apparatus further comprises an implantable volume filling device having an outer surface comprising a biocompatible material, wherein the motion restriction device is in a position between the patient's diaphragm and the stomach wall below the stomach. Adapted to rest against the stomach wall of the patient, thereby limiting the movement of the cardinal notch of the patient's stomach in the direction of the patient's diaphragm when implanting the motion restriction device into the patient, Can be prevented from sliding into the patient's chest through the opening in the patient's diaphragm, thus maintaining the support pressure against the patient's cardia sphincter by the patient's abdomen, and the volume filling device is at least 125 mm 3 And an outer periphery of at least 15 mm, and the apparatus comprises a fixation device adapted to fix the volume filling device in said position when implanting the volume filling device .

  In another embodiment, the device is further adapted to treat reflux disease. For this purpose, the apparatus further comprises an implantable motion restriction device adapted to be at least partially invaginated by the stomach wall at the bottom of the patient's stomach and having an outer surface comprising a biocompatible material. Most of the outer surface of the restriction device rests against the stomach wall at a location between the patient's diaphragm and at least a portion of the lower stomach wall below the invaded stomach without damaging the stomach wall. Adapted to restrict movement of the cardinal notch of the patient's stomach in the direction of the patient's diaphragm when invading the motion restriction device, the cardia passing through the opening of the patient's diaphragm To support the patient's cardia sphincter by the patient's abdomen, and the motion restriction device has a size of at least 125 mm3 and at least 1 The apparatus further includes at least one operable traction device that is implantable in an obese patient and adapted to pull a portion of the patient's stomach wall to create a feeling of fullness. A traction device.

In another embodiment, the device is further adapted to treat reflux disease. For this purpose, the apparatus further comprises an implantable motion restriction device having an outer surface comprising a biocompatible material, wherein the motion restriction device is in a position between the patient's diaphragm and the stomach wall below the stomach. Adapted to rest against the stomach wall of the patient, thereby limiting the movement of the cardinal notch of the patient's stomach in the direction of the patient's diaphragm when implanting the motion restriction device into the patient, Can be prevented from sliding through the opening of the patient's diaphragm into the patient's chest, thus maintaining the support pressure against the patient's cardia sphincter by the patient's abdomen and the motion restriction device is at least 125 mm 3. And an outer periphery of at least 15 mm, and the apparatus comprises a fixation device adapted to fix the volume filling device in the position when implanting the motion restriction device In addition,
A traction device is provided that includes at least one operable traction device that is implantable in an obese patient and adapted to pull a portion of the stomach wall of the patient to create a feeling of fullness.

  In certain embodiments, the apparatus further comprises an external control unit for controlling the volume filling device from outside the patient's body. The external control unit may comprise a wireless remote control adapted to control the device from outside the patient's body. Alternatively, the external control unit may comprise a subcutaneously placed switch or reservoir adapted to control the device from outside the patient's body.

  In certain embodiments, the apparatus further comprises a sensor or sensing device adapted to be implanted in the patient's body, and the implantable control unit is adapted to sense patient intake directly or indirectly. Utilizing information from the sensor or sensing device, it is adapted to control the device from within the patient's body.

  According to another aspect of the invention, there is provided a device for treating obesity in an obese patient having a stomach with a food cavity, the device adapted to be at least substantially invaginated by a stomach wall portion of the patient. And comprising at least one volume filling device having an outer surface comprising a biocompatible material, the volume filling device being disposed inside the stomach with the outer surface of the volume filling device resting against the inside of the stomach wall. Adapted to reduce the volume of the food cavity by a volume substantially exceeding the volume of the volume filling device, and the volume filling device has a maximum circumference of at least 30 millimeters.

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

  In another preferred embodiment, the apparatus comprises a wireless remote control for non-invasive control of 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 pump for operating 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 comprising at least one segment. The size of the volume filling device is hydraulically adjustable, the adjustment device comprising a hydraulic fluid reservoir connected to at least one of the volume filling device segments when implanted in the patient, wherein the hydraulic fluid is at least from the reservoir. Non-invasively adjust the size of the volume filling device by moving to one volume filling device and adjusting the size of at least one segment of the volume filling device. The apparatus can further comprise a hydraulic adjustment device comprising at least one chamber that is invaginated into the patient's stomach wall in conjunction with the volume filling device when implanted in the patient. Distributing the hydraulic fluid between the hydraulic fluid reservoir and the at least one chamber non-invasively adjusts the amount of hydraulic fluid contained in at least one of the volume filling device segments. Preferably, when implanted in the patient, a pump in the reservoir is used to fill the at least one chamber with hydraulic fluid and pull the stomach wall below the stomach to create a feeling of fullness for the patient. The adjustment device further comprises a reverse servo comprising three reservoirs adjustable with hydraulic fluid, in a first reservoir located subcutaneously that is part of a first closed system comprising a second reservoir. A small volume of hydraulic fluid is compressed with a strong force per unit area to move a small volume of hydraulic fluid, and the second reservoir affects a larger volume of hydraulic fluid in the third reservoir. And this third reservoir is part of a second closed system having a larger volume than the first reservoir, so that a lower total force of hydraulic pressure with a smaller force per unit area. Generate liquid movement. The apparatus of the embodiments discussed herein can be equipped with wireless remote control, and the volume filling device is non-invasively adjusted with wireless remote control when implanted in a patient. The apparatus of the embodiments discussed herein can further comprise an energy source that powers the adjustable volume filling device when implanted in a patient. Preferably, the energy source comprises an internal energy source that is implantable into the patient. The energy source can also include an external energy source that transmits wireless energy. When implanted in a patient, the internal energy source can be rechargeable with wireless energy transmitted by the external energy source. The wireless remote control can comprise at least one external signal transmitter and receiver, and further can receive a signal transmitted by the external signal transmitter and send a feedback signal back to the remote control, which is an implantable internal signal to the patient. A receiver and transmitter may be provided. The wireless control signal can include an electric field or magnetic field or a combination of electric and magnetic fields.

  In one embodiment, the device comprises a wireless energy transmitter for non-invasively powering any part of the device when energy delivery is required. Preferably, the energy transmitter transmits energy by at least one wireless energy signal. Preferably, the wireless energy includes a waveform signal or wave field, or the wireless energy signal can include an electric field or magnetic field or a combination of electric and magnetic fields. Preferably, the waveform signal is a sound wave signal, an ultrasonic signal, an electromagnetic wave vibration, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal, a radio wave signal, an X-ray irradiation signal, and a gamma ray irradiation signal. Selected from the group consisting of The apparatus of this embodiment may further comprise an implantable accumulator and an energy conversion device that converts wireless energy into electrical energy, the electrical energy at least partially for charging the accumulator or energy. Used to direct directly from the energy conversion device to any part of the device that consumes.

  In one embodiment, the device comprises a sensor for sensing patient parameters, functional parameters or physical parameters. The functional parameters correlate with the wireless conversion of energy to charge an internal energy source that can be implanted in the patient. The apparatus can further comprise a feedback device that, when implanted in the patient, transmits feedback information related to the functional parameter from within the patient to outside the body. The apparatus can also include an implantable internal control unit for controlling the volume filling device according to a sensor that senses the functional parameter. The sensor for sensing the physical parameter is a pressure sensor or a motility sensor. The implantable internal control unit can control the volume filling device of the apparatus according to sensors that sense physical parameters.

  In one embodiment, the apparatus comprises an operating device for operating the volume filling device to control the size and / or shape of the volume filling device. For this purpose, the operating device can 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 powers the operating device to provide kinetic energy for operation of the volume filling device. Used to generate The wireless energy can be used, for example, to power the operating device directly and generate kinetic energy for operation of the volume filling device, where the wireless energy is transmitted at the energy transmission device. The volume filling device may also be adapted to receive energy from a direct energy conversion device during wireless energy conversion or from an energy accumulator rechargeable with wireless energy and energy conversion device. Preferably, the wireless energy is a sound wave signal, an ultrasonic signal, an electromagnetic wave vibration, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal, a radio wave signal, an X-ray irradiation signal, and a gamma ray irradiation signal. A waveform signal selected from the group consisting of: The wireless energy signal can also include an electric or magnetic field or a combination of electric and magnetic fields.

  In one embodiment of the device, the device further comprises an implantable electronic component that includes at least one voltage level guard or at least one low current guard.

  In one embodiment of the apparatus, at least one of the volume filling device segments has at least one flat surface. Preferably, the volume filling device segment has a polyhedral shape, preferably one of the following shapes: tetrahedron, hexahedron, octahedron, dodecahedron, and icosahedron.

  In one embodiment of the device, a friction enhancing material is provided. This increases the friction between adjacent volume filling device segments and stabilizes the volume filling device. Preferably, the friction enhancing material is an adhesive or a pressure sensitive adhesive. Alternatively, at least one of the volume filling device segments has a textured surface.

  In one embodiment of the apparatus, at least one of the volume filling device segments has a spherical shape. Alternatively, it has at least one flat surface.

  In certain alternative embodiments, the apparatus includes a fluid to reduce friction between adjacent volume filling device segments. This allows the volume filling device to more easily adapt its shape to the movement of the patient's body.

  In one embodiment, the apparatus includes a friction reducing material on the outer surface of the volume filling device segment. The friction reducing material may be a fluid that reduces friction between adjacent volume filling device segments.

  The apparatus may comprise an inflatable second volume filling device segment for sealing two or more first volume filling device segments different from the second volume filling device segment, The volume filling device segment and the first volume filling device segment together form a volume filling device. In one alternative, the second volume filling device segment includes friction reducing material on its inner surface, and the friction reducing material contacts the first volume filling device segment upon implantation.

  The second volume filling device segment may be adapted to be filled with a fluid that allows interaction between adjacent first volume filling device segments so that when the volume filling device is invaginated into the stomach wall. The shape of the volume filling device is adapted to the movement of the stomach wall. And at least the wall portion of the second volume filling device segment is preferably flexible or stretchable.

  The fluid supplied into the volume filling device may be isotonic or hypertonic.

  The volume filling device segment may be adapted to be inserted into a sac formed by a portion of the patient's stomach wall. The volume filling device segment may be adapted to be directly or indirectly filled into a sac formed by a portion of a patient's stomach wall via a tube-type device.

  In one embodiment, the volume filling device includes a liquid that solidifies.

  This liquid or fluid may be supplied to the sac using a conduit.

  In one embodiment, a plurality of volume filling device segments are adapted to be interconnected to form a volume filling device after inserting the plurality of volume filling device segments into a human or artificial sac. The

  In this apparatus, the volume filling device segments are adapted to be assembled into an implantable volume filling device.

  Preferably, the volume filling device segment is adapted to form an implantable volume filling device having a controlled size. In general, any applicable feature or embodiment or portion of an embodiment or method described herein is valid for both the volume filling device and the volume filling device segment when applied.

  The method of operation may use any device, part of a device or system or part of a system, or any claimed embodiment described anywhere in this specification, in any combination.

The following method steps can be applied to any method or part of a method that is used in any combination and that uses any device or part of a device or any combination of features, the method comprising: One or more of the following operational method steps may be included:
-Introducing the device into the throat,
-Going through the esophagus,
Placing a unit for delivering an anvil or fixation member at a position between the esophageal cardia and the diaphragm for engagement in fixation of the esophagus to gastric tissue;
-Going through the esophagus and further through the stomach,
-Filling the stomach with gas to expand the stomach,
-If the device is equipped with a camera, watch the guide video,
-Aspirating fluid from the stomach,
-Engaging the device with the stomach;
-Generating and suturing at least one sac in the stomach wall;
Filling the at least one sac with fluid and / or a volume filling device or two or more volume filling devices;
-Delivering a plurality of volume filling devices through the tube member to the sac created in the stomach tissue;
-Piercing the stomach wall with the above devices,
-Piercing the stomach wall with the instrument to position the volume filling device outside the stomach wall;
Piercing the stomach wall with the device for tube positioning that allows positioning of the subcutaneous injection port;
-Placing a subcutaneous injection port;
-Suturing or stapling the stomach wall from its inside to the esophagus;
-Suturing or stapling the stomach wall from the inside of the stomach to the stomach wall;
-Engaging the device with the esophagus;
-Suturing or stapling one layer of stomach tissue to one layer of esophageal tissue;
-Stitching or stapling two layers of stomach tissue to one layer of esophageal tissue;
-Stitching or stapling three layers of stomach tissue into one layer of esophageal tissue;
-Stitching or stapling four layers of stomach tissue into one layer of esophageal tissue;
-Stitching or stapling one or more layers of stomach tissue to two or more locations of esophageal tissue, the esophagus having a central axis of the esophagus, the esophagus being in relation to the central axis of the esophagus A first point along a first esophageal surface length axis substantially parallel to the central axis of the esophagus, further comprising a substantially cylindrical inner and outer surfaces extending radially; And a second along a second esophageal surface length axis substantially parallel to the esophageal central axis and spaced radially from the first esophageal surface length axis with respect to the esophageal central axis. To be attached to esophageal tissue both in terms of
-Delivery of the fixation member by a unit located in the device;
Piercing the fixation member into at least one layer of stomach tissue and one layer of esophageal tissue;
-Placing the fixation member above the gastroesophageal junction and creating a tunnel between the esophagus and the stomach above the junction;
-Positioning the esophagus part in the esophagus and the stomach part in the stomach;
-Placing the anchoring member substantially between the stomach part and the esophagus part;
-Inserting the device through the cardia into the main part of the gastric cavity and adapting the device to face the skull so that it reaches the position of the unit above the junction;
-When such a tunnel is created, this tunnel placed at the junction allows a virtually unlimited contraction and release of the sphincter closing the cardia.

The following method steps can be applied to any method or part of a method that is used in any combination and that uses any device or part of a device or any combination of features, the method comprising: One or more of the following operational method steps may be included:
-Cutting the patient's skin,
-Creating an opening in the patient's abdominal wall;
Introducing the device into the abdominal cavity through the opening in the abdominal wall;
-Engaging the device with the stomach;
-Withdrawing the device into the stomach wall to produce at least one preformed sac of the stomach wall;
-Clamping the stomach wall to produce at least one preformed sac of the stomach wall;
-Suturing or stapling at least one sac of the stomach wall;
Filling the at least one sac with fluid and / or a volume filling device or two or more volume filling devices;
-Delivering a plurality of volume filling devices through the tube member to the sac created in the stomach tissue;
-Penetrating the stomach wall into the stomach with the above equipment,
-Piercing the stomach wall with the instrument to position the volume filling device outside the stomach wall;
-Piercing the stomach wall with the above device to suture the stomach wall to the esophageal wall,
-Placing the volume filling device outside the stomach wall,
-Invagination of the volume filling device into the stomach wall,
-Placing a subcutaneous injection port;
-Suturing or stapling the stomach wall from the outside of the stomach to the stomach wall;
-Stitching or stapling the stomach wall from the outside of the stomach to the stomach wall without penetrating the mucosa,
-Stitching or stapling the two layers of the stomach wall to one or two layers of the stomach wall;
-Engaging the device with the esophagus;
-Clamping on both sides of the esophagus to secure one layer of the esophageal wall to one or two layers of stomach tissue;
-Clamping to the stomach walls on both sides of the esophagus and at the bottom of the stomach to secure one layer of the esophagus wall to one or two layers of stomach tissue;
Introducing into the esophagus a tube or endoscopic device comprising an anvil member or a fixed delivery member involved in the fixation of the esophagus to the stomach;
-Aligning the position of the anvil member or fixed delivery member in the esophagus with respect to the device clamping around the esophagus;
-Suturing or stapling one layer of stomach tissue to one layer of esophageal tissue;
-Stitching or stapling two layers of stomach tissue to one layer of esophageal tissue;
-Stitching or stapling three layers of stomach tissue into one layer of esophageal tissue;
-Stitching or stapling four layers of stomach tissue into one layer of esophageal tissue;
-Using staplers with different stapling depths, stapling at different positions in the stapler row;
-Stapling the stomach into the esophagus with one first stapling depth and stapling the stomach into the stomach with a second stapling depth less than the first depth;
-Stapling the stomach-to-stomach sac with a stapler row, further comprising stapling the esophagus with a greater depth stapler included as part of the stapler row; Stapling,
-Stitching or stapling one or more layers of stomach tissue to two or more locations of esophageal tissue, the esophagus having a central axis of the esophagus, the esophagus being in relation to the central axis of the esophagus A first point along a first esophageal surface length axis substantially parallel to the central axis of the esophagus, further comprising a substantially cylindrical inner and outer surfaces extending radially; And a second along a second esophageal surface length axis substantially parallel to the esophageal central axis and spaced radially from the first esophageal surface length axis with respect to the esophageal central axis. To be attached to esophageal tissue both in terms of
-Delivery of the fixation member by a unit located in the device;
Piercing the fixation member into at least one layer of stomach tissue and one layer of esophageal tissue;
-Placing the fixation member above the gastroesophageal junction and creating a tunnel between the esophagus and the stomach above the junction;
-When such a tunnel arranged at the junction is created, this tunnel allows a substantially unlimited contraction and release of the sphincter closing the cardia,
-Positioning the esophagus part in the esophagus and the stomach part in the stomach via introduction into the gastric cavity;
-Placing the anchoring member substantially between the stomach part and the esophagus part;
-Inserting the device through the cardia into the main part of the gastric cavity and adapting the device to face the skull so that it reaches the position of the unit above the junction;
In order to allow the device to be inserted into the main part of the gastric cavity, by operating the joint provided by the device to reach the position of the part of the unit of the esophagus above the joint; Bending the joint.

The following method steps can be applied to any method or part of a method that is used in any combination and that uses any device or part of a device or any combination of features, the method comprising: It may include one or more of the following laparoscopic operating method steps:
-Cutting the patient's skin,
-Introducing a tube through the abdominal wall,
Filling the abdominal cavity with fluid or gas,
-Introducing more than one trocar into the abdominal cavity,
Introducing the camera into the abdominal cavity through one of the trocars;
Introducing the device through the trocar into the abdominal cavity;
-Engaging the device with the stomach;
-Withdrawing the device into the stomach wall to produce at least one preformed sac of the stomach wall;
-Clamping the stomach wall to produce at least one preformed sac of the stomach wall;
-Suturing or stapling at least one sac of the stomach wall;
Filling the at least one sac with fluid and / or a volume filling device or two or more volume filling devices;
-Delivering a plurality of volume filling devices through the tube member to the sac created in the stomach tissue;
-Penetrating the stomach wall into the stomach with the above equipment,
-Piercing the stomach wall with the instrument to position the volume filling device outside the stomach wall;
-Piercing the stomach wall with the above device to suture the stomach wall to the esophagus,
-Placing the volume filling device outside the stomach wall,
-Invagination of the volume filling device into the stomach wall,
-Placing a subcutaneous injection port;
-Suturing or stapling the stomach wall from the outside of the stomach to the stomach wall;
-Stitching or stapling the two layers of the stomach wall to one or two layers of the stomach wall;
-Stitching or stapling the stomach wall from the outside of the stomach to the stomach wall without penetrating the mucosa,
-Engaging the device with the esophagus;
-Clamping on both sides of the esophagus to secure one layer of the esophageal wall to one or two layers of stomach tissue;
-Clamping to the stomach walls on both sides of the esophagus and at the bottom of the stomach to secure one layer of the esophagus wall to one or two layers of stomach tissue;
Introducing into the esophagus a tube or endoscopic device comprising an anvil member or a fixed delivery member involved in the fixation of the esophagus to the stomach;
-Aligning the position of the anvil member or fixed delivery member in the esophagus with respect to the device clamping around the esophagus;
-Suturing or stapling one layer of stomach tissue to one layer of esophageal tissue;
-Stitching or stapling two layers of stomach tissue to one layer of esophageal tissue;
-Stitching or stapling three layers of stomach tissue into one layer of esophageal tissue;
-Stitching or stapling four layers of stomach tissue into one layer of esophageal tissue;
-Using staplers with different stapling depths, stapling at different positions in the stapler row;
-Stapling the stomach into the esophagus with one first stapling depth and stapling the stomach into the stomach with a second stapling depth less than the first depth;
-Stapling the stomach-to-stomach sac with a stapler row, further comprising stapling the esophagus with a greater depth stapler included as part of the stapler row; Stapling,
-Stitching or stapling one or more layers of stomach tissue to two or more locations of esophageal tissue, the esophagus having a central axis of the esophagus, the esophagus being in relation to the central axis of the esophagus A first point along a first esophageal surface length axis substantially parallel to the central axis of the esophagus, further comprising a substantially cylindrical inner and outer surfaces extending radially; And a second along a second esophageal surface length axis substantially parallel to the esophageal central axis and spaced radially from the first esophageal surface length axis with respect to the esophageal central axis. To be attached to esophageal tissue both in terms of
-Delivery of the fixation member by a unit located in the device;
Piercing the fixation member into at least one layer of stomach tissue and one layer of esophageal tissue;
-Placing the fixation member above the gastroesophageal junction and creating a tunnel between the esophagus and the stomach above the junction;
-When such a tunnel arranged at the junction is created, this tunnel allows a substantially unlimited contraction and release of the sphincter closing the cardia,
-Positioning the esophagus part in the esophagus and the stomach part in the stomach via introduction into the gastric cavity;
-Placing the anchoring member substantially between the stomach part and the esophagus part;
-Insert the device through the cardia into the main part of the gastric cavity below the junction and adapt the device to face the skull so that the device reaches the position of the unit above the junction about,
In order to allow the device to be inserted into the main part of the gastric cavity, by operating the joint provided by the device to reach the position of the part of the unit of the esophagus above the joint; Bending the joint.

  Any embodiment or part of an embodiment, and any method or part of a method, or any device or part of a device, or any feature or part of a feature, or any system or part of a system Note that, or any drawing or part of a drawing can be combined in any applicable manner. All examples presented here are to be considered part of the general description and can therefore be combined in any way in a general sense.

  Those skilled in the art will be able to combine the steps, change the order of the steps, and the invention without any inventive effort and without departing from the scope of the invention as defined in the description and the claims. It should be understood that elements of different embodiments can be combined.

  The invention will now be described in more detail using non-limiting examples and with reference to the accompanying drawings.

FIG. 1 is a general view of a patient showing the general shape of the stomach. FIG. 2a shows a first embodiment of an apparatus for treating obesity implanted in a human patient. 2b is a cross-sectional view taken along line IIb-IIb of FIG. 2a. Fig. 3a is a diagram showing certain shapes and features of a volume filling device provided in an apparatus according to the present invention. FIG. 3b shows the specific shape and features of the volume filling device provided by the apparatus according to the invention. Fig. 3c shows the specific shape and features of the volume filling device provided by the apparatus according to the invention. FIG. 3d shows the specific shape and features of the volume filling device that the apparatus according to the invention comprises. FIG. 3e shows the specific shape and features of the volume filling device provided by the apparatus according to the invention. FIG. 3f shows the specific shape and features of the volume filling device that the apparatus according to the invention comprises. FIG. 3g shows the specific shape and features of the volume filling device provided by the apparatus according to the invention. FIG. 3h shows the specific shape and features of the volume filling device that the apparatus according to the invention comprises. Fig. 3i is a diagram showing certain shapes and features of the volume filling device provided by the apparatus according to the invention. Fig. 3j is a diagram showing certain shapes and features of the volume filling device provided by the apparatus according to the invention. FIG. 3k shows the specific shape and features of the volume filling device provided by the apparatus according to the invention. FIG. 3m shows the specific shape and features of the volume filling device provided by the apparatus according to the invention. FIG. 3 n shows the specific shape and characteristics of the volume filling device provided by the apparatus according to the invention. FIG. 3p shows the specific shape and features of the volume filling device provided by the apparatus according to the invention. FIG. 4a shows a deflated, inflatable volume filling device with an apparatus according to the invention. Fig. 4b shows an inflatable volume filling device and an apparatus for placing the volume filling device in a deflated state with an apparatus according to the invention. Fig. 4c shows an apparatus for placing a volume filling device provided in an apparatus according to the invention. FIG. 4d shows an inflatable volume filling device and an apparatus for placing the volume filling device in a deflated state with an apparatus according to the invention. FIG. 5a illustrates one of the steps of invading the expandable device of FIG. 4a outside the stomach wall of the patient. FIG. 5b illustrates one of the steps of invading the expandable device of FIG. 4a outside the stomach wall of the patient. FIG. 5c illustrates one of the steps of invading the inflatable device of FIG. 4a outside the stomach wall of the patient. FIG. 5d illustrates one of the steps of invading the expandable device of FIG. 4a outside the stomach wall of the patient. FIG. 5e illustrates one of the steps of invading the expandable device of FIG. 4a outside the patient's stomach wall. FIG. 5f illustrates one of the steps of invading the inflatable device of FIG. 4a outside the stomach wall of the patient. FIG. 5g shows one of the steps of invading the expandable device of FIG. 4a outside the stomach wall of the patient. FIG. 5h illustrates one of the steps of invading the inflatable device of FIG. 4a outside the stomach wall of the patient. FIG. 5i illustrates one of the steps of invading the expandable device of FIG. 4a outside the stomach wall of the patient. FIG. 6a shows an alternative embodiment in which the volume filling device is adapted to be non-invasively adjustable post-operatively. FIG. 6b shows an alternative embodiment in which the volume filling device is adapted to be non-invasively adjustable after surgery. FIG. 7 illustrates an alternative embodiment in which the volume filling device is adapted to be non-invasively adjustable post-operatively. FIG. 8 shows an alternative embodiment in which the volume filling device is adapted to be non-invasively adjustable post-operatively. FIG. 9 illustrates an embodiment in which the volume filling device is adapted to invaginate in the lower region of the patient's stomach. FIG. 10 illustrates an embodiment in which the volume filling device is adapted to invaginate in the lower region of the patient's stomach. FIG. 11 a is a diagram showing an embodiment in which the reflux disease treatment apparatus is applicable to obesity treatment and includes a plurality of motion restriction device segments. FIG. 11 b shows an embodiment in which a motion restriction device segment that does not include any outer layers is provided in a sac-like portion created in a portion of the stomach wall. FIG. 11 c is similar to the embodiment shown in FIG. 11 b, but the proximal portion of the combined reflux and obesity treatment device has a different configuration than the distal portion of the combined reflux and obesity treatment device. FIG. FIG. 12 shows an embodiment where a volume filling device also adapted for the treatment of reflux disease is combined with a traction device for traction of a portion of the stomach wall in the lower part of the stomach. FIG. 13 illustrates an alternative embodiment using a combination of volume filling device and traction device. FIG. 14 illustrates an alternative embodiment using a combination of volume filling device and traction device. FIG. 15 illustrates an alternative embodiment using a combination of volume filling device and traction device. FIG. 16 illustrates an alternative embodiment using a combination of volume filling device and traction device. FIG. 17a shows an embodiment in which a volume filling device is provided inside the stomach wall. FIG. 17b shows an embodiment in which a volume filling device is provided inside the stomach wall. FIG. 18a illustrates one of the steps of invading the inflatable device of FIG. 4a inside the stomach wall of a patient. FIG. 18b shows one of the steps of invading the inflatable device of FIG. 4a inside the stomach wall of the patient. FIG. 18c illustrates one of the steps of invading the expandable device of FIG. 4a inside the patient's stomach wall. FIG. 18d shows one of the steps of invading the inflatable device of FIG. 4a inside the stomach wall of the patient. FIG. 18e illustrates one of the steps of invading the inflatable device of FIG. 4a inside the patient's stomach wall. FIG. 18f illustrates one of the steps of invading the inflatable device of FIG. 4a inside the stomach wall of a patient. FIG. 18g shows one of the steps of invading the inflatable device of FIG. 4a inside the stomach wall of the patient. FIG. 18h shows one of the steps of invading the expandable device of FIG. 4a inside the stomach wall of the patient. FIG. 19a illustrates one of the steps of invading the inflatable device of FIG. 4a inside the stomach wall of a patient. FIG. 19b shows one of the steps of invading the inflatable device of FIG. 4a inside the stomach wall of a patient. FIG. 19c illustrates one of the steps of invading the inflatable device of FIG. 4a inside the patient's stomach wall. FIG. 19d shows one of the steps of invading the inflatable device of FIG. 4a inside the stomach wall of the patient. FIG. 19e illustrates one of the steps of invading the inflatable device of FIG. 4a inside the stomach wall of a patient. FIG. 19f shows one of the steps of invading the inflatable device of FIG. 4a inside the stomach wall of the patient. FIG. 19g shows one of the steps of invading the inflatable device of FIG. 4a inside the stomach wall of the patient. FIG. 19h illustrates one of the steps of invading the inflatable device of FIG. 4a inside the stomach wall of a patient. FIG. 19i illustrates one of the steps of invading the inflatable device of FIG. 4a inside the stomach wall of a patient. FIG. 19j shows one of the steps of invading the inflatable device of FIG. 4a inside the stomach wall of the patient. FIG. 20a illustrates one of the steps of invading the inflatable device of FIG. 4a inside the patient's stomach wall. FIG. 20b illustrates one of the steps of invading the expandable device of FIG. 4a inside the patient's stomach wall. FIG. 20c illustrates one of the steps of invading the inflatable device of FIG. 4a inside the stomach wall of a patient. FIG. 20d shows one of the steps of invading the inflatable device of FIG. 4a inside the stomach wall of the patient. FIG. 20e illustrates one of the steps of invading the expandable device of FIG. 4a inside the patient's stomach wall. FIG. 20f illustrates one of the steps of invading the inflatable device of FIG. 4a inside the stomach wall of a patient. FIG. 21a shows an instrument for surgically applying an implantable device. FIG. 21b shows an instrument for surgically applying an implantable device. FIG. 22 is an overall view of a patient implanted with a device for treating obesity. FIG. 23 illustrates a particular mode of powering a device for treating obesity implanted in a human patient. FIG. 24 illustrates a particular mode of powering a device for treating obesity implanted in a human patient. FIG. 25 is a diagram illustrating a particular mode of powering a device for treating obesity implanted in a human patient. FIG. 26 illustrates a particular mode of powering a device for treating obesity implanted in a human patient. FIG. 27 illustrates a particular mode of powering a device for treating obesity implanted in a human patient. FIG. 28 illustrates a particular mode of powering a device for treating obesity implanted in a human patient. FIG. 29 illustrates a particular mode of powering a device for treating obesity implanted in a human patient. FIG. 30 illustrates a particular mode of powering a device for treating obesity implanted in a human patient. FIG. 31 illustrates a particular mode of powering a device for treating obesity implanted in a human patient. FIG. 32 illustrates a particular mode of powering a device for treating obesity implanted in a human patient. FIG. 33 illustrates a particular mode of powering a device for treating obesity implanted in a human patient. FIG. 34 illustrates a particular mode of powering a device for treating obesity implanted in a human patient. FIG. 35 illustrates a particular mode of powering a device for treating obesity implanted in a human patient. FIG. 36 illustrates a particular mode of powering a device for treating obesity implanted in a human patient. FIG. 37 illustrates a particular mode of powering a device for treating obesity implanted in a human patient. FIG. 38 illustrates a particular mode of powering a device for treating obesity implanted in a human patient. FIG. 39 illustrates a particular mode of powering a device for treating obesity implanted in a human patient. FIG. 40 illustrates a particular mode of powering a device for treating obesity implanted in a human patient. FIG. 41 illustrates a particular manner of powering a device for treating obesity implanted in a human patient. FIG. 42 illustrates a particular mode of powering a device for treating obesity implanted in a human patient, either hydraulically or pneumatically. FIG. 43 is a diagram illustrating a particular manner of powering a device for treating obesity implanted in a human patient, either hydraulically or pneumatically. FIG. 44 illustrates a particular manner of hydraulically or pneumatically powering a device for treating obesity implanted in a human patient. FIG. 45 illustrates a particular manner of hydraulically or pneumatically powering a device for treating obesity implanted in a human patient. FIG. 46a illustrates a particular manner of powering a device for treating obesity implanted in a human patient, either hydraulically or pneumatically. FIG. 46b illustrates a particular manner of hydraulically or pneumatically powering a device for treating obesity implanted in a human patient. FIG. 46c illustrates a particular manner of powering a device for treating obesity implanted in a human patient, either hydraulically or pneumatically. FIG. 47 illustrates a particular manner of hydraulically or pneumatically powering a device for treating obesity implanted in a human patient. FIG. 48a illustrates a particular manner of powering a device for treating obesity implanted in a human patient, either hydraulically or pneumatically. FIG. 48b shows a particular manner of hydraulically or pneumatically powering a device for treating obesity implanted in a human patient. FIG. 48c illustrates a particular manner of hydraulically or pneumatically powering a device for treating obesity implanted in a human patient. FIG. 49 is a diagram showing invagination of a plurality of volume filling devices. FIG. 50 is a diagram showing an embodiment of the volume filling device in a state of segments before assembly. FIG. 51 is a view of assembling the first part and the second part of the embodiment of the volume filling device. FIG. 52 is a view when the third part and the fourth part are assembled in the embodiment of FIG. FIG. 53 is a view when the last part of the embodiment of FIG. 52 is assembled. FIG. 54 is a view of the embodiment of FIGS. 50-53 when it is finally assembled. FIG. 55a shows the core component of the embodiment of FIG. 50 with an operating channel. 55b is a cross-sectional view of the core component of FIG. 55a in the plane II. FIG. 55c is a cross-sectional view of the core part of FIG. 55a in the plane II-II. 55d is a cross-sectional view of the core part of FIG. 55a in the plane III-III. FIG. 55e is a cross-sectional view of the core part of FIG. 55a in the plane IV-IV. FIG. 55f is a cross-sectional view of the core part of FIG. 55a in the plane VV. FIG. 56 illustrates a particular embodiment of a volume filling device segment. FIG. 57 illustrates a specific embodiment of a volume filling device segment. FIG. 58a shows the insertion of the volume filling device segment of FIG. 56 with an instrument. FIG. 58b shows the insertion of the volume filling device segment of FIG. 56 with an instrument. FIG. 58c shows the insertion of the volume filling device segment of FIG. 56 with an instrument. 58d shows the insertion of the volume filling device segment of FIG. 56 with an instrument. FIG. 59a illustrates a preferred method of indenting a plurality of volume filling device segments into the stomach wall using an instrument. FIG. 59b illustrates a preferred method of indenting a plurality of volume filling device segments into the stomach wall using an instrument. FIG. 59c illustrates a preferred method of indenting a plurality of volume filling device segments into the stomach wall using an instrument. FIG. 60 is an illustration of an alternative device that indents multiple volume filling device segments. FIG. 61a shows a particular shape of a volume filling device when a volume filling device is formed using a plurality of volume filling device segments. FIG. 61b shows a specific shape of the volume filling device when a volume filling device is formed using a plurality of volume filling device segments. FIG. 61c shows a particular shape of the volume filling device when a volume filling device is formed using multiple volume filling device segments. FIG. 61d shows a specific shape of the volume filling device when a volume filling device is formed using multiple volume filling device segments. FIG. 61e shows a specific shape of the volume filling device when a plurality of volume filling device segments are used to form the volume filling device. FIG. 62 is a cross-sectional view of a volume filling device containing fluid. FIG. 63 is a cross-sectional view of a volume filling device that defines a plurality of volume filling device segments. FIG. 64 illustrates a volume filling device including a plurality of volume filling device segments included in a fluid. FIG. 65 is a cross-sectional view of a volume filling device that defines a plurality of volume filling device segments included in a fluid.

  Preferred embodiments of the present invention will now be described in detail with reference to the drawings.

  The term “segment” as used herein should be construed broadly to define any part into which an object can be divided.

  FIG. 1 shows a human patient 1 being treated for obesity. A volume filling device 10 is provided to reduce the internal volume of the stomach 12, i.e., the food cavity of the stomach, to affect the patient's appetite. The function and operation of this volume filling device will be described and explained in detail in the following description.

  2a and 2b show a first embodiment of a device for treating obesity according to the present invention, FIG. 2a shows a side view of the stomach, and FIG. 2b shows a cross-sectional view along line IIb-IIb of FIG. 2a. It is. The apparatus comprises a volume filling device 10 that is implanted in a human patient. More specifically, in the embodiment of FIG. 2a, the volume filling device 10 is invaginated into the stomach wall 12a of the patient's stomach 12, outside the stomach wall. The body of the volume filling device 10 is elongated and shaped to rest against the stomach wall 12a of the stomach 12, and further has an outer surface suitable for resting against the stomach wall.

  By invading the volume filling device 10 into a portion of the stomach wall, the size of the food cavity, generally indicated at 12b in FIG. 2b, is reduced, resulting in a feeling of fullness sooner after eating.

  Preferably, the volume filling device 10 comprises an elastic material such as silicone. This allows the volume filling device to adapt to stomach movements, the degree of eating, etc.

  By manufacturing the volume filling device from a biocompatible material, the risk of the patient's body refusing to transplant is greatly reduced.

  The volume filling device 10 can be secured to the stomach wall 12a of the stomach 12 in a number of different ways. In the embodiment shown in FIG. 2b, the volume filling device 10 is invaginated in the stomach wall 12a. After invagination, numerous sutures or stapling 14 between the stomachs are applied to maintain the invagination for a short period of time. This helps the growth of human tissues that maintain the invagination for a long time.

  Preferably, the volume filling device 10 has an essentially rounded shape so as not to damage the stomach wall. An example is shown in FIG. 3a, where the volume filling device is essentially oval. In another preferred embodiment, the volume filling device is slightly bent, as in the embodiment shown in FIG. 3b. However, because the stomach wall is tough, a great many different shapes, forms, and dimensions may be used. In one embodiment, the volume filling device has a diameter of about 40 millimeters and a length of about 120 millimeters, resulting in a volume that is about half the volume of the patient's stomach. However, the maximum perimeter of the volume filling device is preferably at least 30 millimeters, more preferably at least 50 millimeters, and even more preferably at least 80 millimeters.

  The volume filling device need not be elongated. In the embodiment shown in FIG. 3c, the volume filling device 10 is essentially spherical or ball-shaped. Two or more such volume filling devices can be combined to fill the stomach to achieve the desired reduction in the food cavity of the patient's stomach.

  Reference was made to securing the volume filling device by stitching or stapling between the stomachs. To further improve the fixation, the volume filling device may be provided with a waist having a diameter that is smaller than the re-large diameter of the volume filling device. Such a volume filling device having a waist 10a is shown in FIG. 3d.

  The volume filling device 10 may consist of at least two interconnectable parts, whereby each part can be more easily inserted into the stomach and even through the hole in the stomach wall. FIG. 3e thus comprises two generally spherical child parts 10b, 10c, which are preferably interconnected by portions having a smaller diameter. This smaller diameter part may be provided with interconnecting means having a reversible function, whereby the two interconnected child parts 10b, 10c can subsequently be disconnected. Such means may comprise a bayonet socket, a screw connection, etc., shown in FIG. Instead, the part with the smaller diameter is fixed on one of the child parts 10b, 10c, such as a resilient locking hook that engages the edge of the hole provided on the other of the child parts 10b, 10c. Interconnects may be provided.

  The configuration of the volume filling device 10 is not limited to one waist portion 10a. Thus, in FIG. 3f, a volume filling device having two waists is shown.

  In order to facilitate the positioning of the volume filling device, attachment means in the form of a handle or the like may be provided on the outer surface of the volume filling device. An example is shown in FIG. 3g, where a detailed view of the handle 10e is also shown. In a preferred embodiment, the attachment means is provided at the end of the volume filling device 10. In order to avoid a protruding portion on the surface of the volume filling device 10, the handle 10e is provided in the same plane as the outer surface of the volume filling device 10, and a recess 10f is provided, thereby achieving a firm grip of the handle 10e. A gripping tool or gripping device (not shown in FIG. 3g) can be provided.

  The volume filling device may comprise a tube for filling the volume filling device with a fluid or gel, or emptying the volume filling device. By injecting a fluid or gel into the volume filling device 10, the volume filling device is expanded to the expanded state described below. Also, the size of the volume filling device can be adjusted by moving fluid or gel from there to different reservoirs.

  A volume filling device 10 adapted for this is shown in FIG. 3h. A tube 10g is fixedly attached to the volume filling device. This tube can be attached to a suitable instrument (not shown) or injection port described in detail below.

  Instead of having a tube that is fixedly attached, the volume filling device 10 may include an injection port 10h adapted to connect with a separate tube (not shown in this view).

  It is important that the volume filling device to be implanted is firmly held in place in the stomach wall where it is invaginated. For this purpose, the volume filling device can be provided with one or more through-holes adapted to receive sutures or stapling used to secure the invagination. Such an embodiment is shown in FIG. 3j, where the volume filling device 10 is provided with a row of holes 10i provided in the protruding flange-like portion of the volume filling device. In this embodiment, the row of holes extends along the longitudinal axis of the volume filling device.

  FIG. 3k shows how the suture 14 is provided to allow it to pass through the stomach wall 12a and the through-hole 10i. In this way, the volume filling device is fixed in place in the sac produced in the stomach wall, thereby preventing sliding.

  Although multiple holes are illustrated in FIG. 3j, it should be understood that an improved fixation of the volume filling device 10 can be obtained with one single hole.

  FIG. 3m shows a volume filling device with an injection port 10h. The volume filling device is invaginated in the stomach wall and the injection port 10h is available for connection with a tube or the like from the patient's abdominal region.

  FIG. 3n shows an invaginated volume filling device, where instead of an injection port, a fixed tube 10g extends into the abdominal region of the patient.

  FIG. 3p is a view similar to FIG. 3m but also showing the tunneling of the connecting tube 10g in the stomach wall between the injection port 10h and the volume filling device 10. FIG.

  It has been shown that the shape of the volume filling device can take many different shapes. It should be understood that the material of the volume filling device can also vary. The volume filling device comprises a coating such as a parylene, polytetrafluoroethylene (PIFE) or polyurethane coating, or a combination of these coatings, ie a multilayer coating. This coating or multilayer coating improves the properties of the volume filling device, such as abrasion resistance.

  In one embodiment, the volume filling device comprises an inflatable device that is inflatable to an inflated state. In this case, the inflatable device comprises a fluid injection port and is adapted to be connected to an endoscopic instrument. This embodiment is described in detail below with reference to FIGS.

  An inflatable volume filling device in an unexpanded state is shown in FIG. 4a. This is a substantially balloon-like, deflated device 10 with an injection port 10h. In this state, the inflatable device has a diameter of up to a few millimeters so that it can be inserted into the stomach through the patient's esophagus using the tube-like endoscopic instrument 600 shown in FIG. 4b. The device includes an outer sleeve 600a and an inner sleeve 600b that can be displaced longitudinally relative to the outer sleeve. The inner sleeve is provided with a cutter in the shape of a cutting blade 615 at its edge end. This cutting blade can be used to cut the stomach wall and open a hole, as will be described in detail below.

  As shown in FIG. 4c, when the device reaches the stomach wall, the inner sleeve is moved forward from its position in the outer sleeve to contact the stomach wall 12a. Next, the cutting blade 615 of the inner sleeve cuts the stomach wall and punctures it so that the volume filling device 10 can be subsequently inserted into and through the hole as shown in FIG. 4d. it can. The device may be provided with a piston 602 to push the volume filling device through the hole. Accordingly, the apparatus further comprises a piston 602 adapted to push the deflated volume filling device 10 from a position in the inner sleeve shown in FIG. 4b to a position outside the inner sleeve shown in FIG. 4d.

  To protect the deflated volume filling device 10 from the inner sleeve cutting blade 615, an additional protective sleeve (not shown) can be provided around the volume filling device.

  An intracavitary method for invading the volume filling device 10 outside the stomach wall 12 will be described with reference to FIGS. First, as shown in FIG. 5a, a device 600, preferably an endoscopic device, is inserted into the patient's mouth. The instrument includes ejection devices 601, 602 for ejecting fluids or devices into the patient's stomach. Furthermore, the device 600 comprises a control unit 606 adapted to control the operation of the device. For this purpose, the control unit 606 comprises one or more steering devices in the form of two joysticks 603 and two control buttons 604 in the illustrated embodiment. For example, to display an image provided by an optical device for viewing the interior of the stomach, such as a camera (not shown) disposed at the outer end of the elongate member 607, as shown in FIGS. A display 605 is provided. A camera, which may include an electrical connection wire extending along the elongate member, is assisted by a light source (not shown) placed distal to the elongate member to illuminate the interior of the stomach. The optical device may also include an optical fiber disposed along the elongate member and drawn from the patient's body to view the interior of the stomach from the outside.

  The device is further inserted into the patient's esophagus and stomach as shown in FIG. 5b. The device 600 creates a hole 12b in the stomach wall of the stomach 12. For this purpose, one or more cutters 615 are provided at the distal end of the instrument, for example in the manner described above with reference to FIGS. These cutters can of course be designed in various ways, such as a toothed drum cutter that rotates about the central axis of a tube-like device.

  After the stomach wall is cut and pierced, the distal end of the device 600 is inserted through the hole 12b and reaches the outside of the stomach wall 12a. This is shown in FIG. 5c, which shows a side view of the stomach 12, and in FIG. 5d, which is a cross-sectional view of the stomach in FIG.

  The device 600 is adapted to create a “pocket” or “sac” outside the stomach 12 and around the hole 12b in the stomach wall. Such a device and a method for providing a sac is described herein.

  5e-i show an endoscope or laparoscope for creating a sac for placing the volume filling device 10 in the gastric wall 12a, thereby causing the volume filling device 10 to be invaginated in the stomach wall 12a of the patient. Indicates equipment. This device, generally indicated at 600 and may comprise the features described above with reference to FIGS. 4a-d, comprises an elongate member 607 having a proximal end and a distal end, the elongate member 607 from the patient's esophagus. Having a small diameter and being flexible, the flexible elongate member 607 can be introduced from its distal end through the patient's throat, esophagus and into the stomach 12 to the stomach wall 12a.

  A gastric piercing device or cutter 615 for piercing the stomach wall 12a can be provided at the distal end of the elongate member 607 to create a hole in the gastric wall 12aa, thereby introducing the elongate member 607 through the hole. The gastric piercing device 615 may be adapted to be operable to withdraw the gastric piercing device 615 after piercing the lower stomach wall 12a of the stomach so as not to further damage tissue in the body. The instrument further comprises a special holding device 609 provided on the side of the elongated member 607 close to the piercing device 615.

  The elongate member further comprises an inflatable member 611 that expands after the elongate member has pierced the stomach wall 12a, thereby assisting in the creation of a cavity or sac adapted to hold the volume filling device 610. The inflatable member 611 may comprise an inflatable circular balloon that is provided around the distal end of the flexible elongate member 607.

  The method steps in invading the volume filling device will now be described in detail. After inserting the device 600 into the stomach, as shown in FIG. 5e, the gastric perforation device 615 is placed in contact with the stomach wall 12a. Next, the gastric perforation device or cutter 615 creates a hole 12b in the stomach wall and transfers at least the expandable member 611 through the hole 12b and into the stomach wall. In this step, the special holding device 609 is put in a holding state, where the special holding device 609 expands radially and has an essentially circular abutment against the stomach wall 12a as shown in FIG. 5f. Forming a surface. In this way, insertion of the gastric piercing device 615 and the expandable member 611 into the stomach wall through the aperture 12b is limited to the position shown in FIG. 5f.

  Next, the expandable member 611 is expanded. In this case, the inflatable member includes a balloon or the like and injects air or other fluid into it.

  The portion of the elongate member 607 with the inflatable member 611 is withdrawn proximally as indicated by the arrow in FIG. 5g and the stomach wall 612 is pulled into a basket or cup-like structure created by a special retention device 609.

  A suturing or stapling device 608 is further provided as a device connected to the elongated member 607 or as a separate instrument. The suturing or stapling member comprises a suturing or stapling end 613 adapted to close the cavity or sac with a suturing or stapling 14 between the stomach and stomach.

  In a further step shown in FIG. 5h, the inflatable volume filling device 10 is placed in a cup-like structure in a deflated state. Then, as shown in FIG. 5i, the volume filling device 10 is expanded to the expanded state. The expansion of the volume filling device 10 can be achieved by injecting a fluid or gel into the volume filling device in a deflated state. This expansion can also be achieved by injecting a material that can be cured, thereby forming a solid device 10. Thus, as a volume filling device 10 shown in FIGS. 5h and 5i, a balloon-like, which is subsequently filled with a fluid or gel, or alternatively filled with a material that is simply injected into a cup-like structure formed by the stomach wall 12a. A device can be illustrated.

  The fluid used to fill the volume filling device 10 may be any suitable fluid, such as saline, suitable for filling the inflatable device. In another embodiment, if the fluid is a fluid adapted to change to a solid state, the fluid may be a liquid polyurethane.

  In order to minimize or completely eliminate leakage, the fluid is isotonic, i.e., the fluid has the same osmolarity as the body fluid of the human body. Another way to prevent diffusion is to use a fluid containing large molecules such as iodine molecules.

  Preferably, the stomach-to-stomach suture or stapling has a net-like structure, promotes the growth of human tissue in contact with the stomach wall, and reliably positions the volume filling device attached to the stomach wall for a long period of time Provide a fixed part adapted to do.

  After partially or fully inflating the expandable device 10, the inflow port 10h (not shown in FIGS. 5h and 5i) of the volume filling device 10 is sealed, and the instrument 600 is pulled out of the hole 12b. 12b is then closed in any suitable manner, such as using the device 600. The instrument is then removed from the stomach 12 and the inflatable inflatable device 10 is invaginated outside the stomach wall by the patient's stomach wall portion. This reduces the internal volume of the stomach and affects the patient's appetite.

  During one or more of the steps described above, the stomach may be inflated with gas, preferably using an endoscopic instrument.

  The volume filling device 10 described above with reference to FIGS. 5a-i has been described as an inflatable volume filling device. It should be understood that an elastic volume filling device is also possible that has a retractable elasticity for insertion into an endoscopic instrument and expands into an expanded state after leaving the instrument.

  Treat obesity with reference to FIGS. 6a and 6b, showing a cross-sectional view of the stomach with the volume filling device indented into the stomach wall outside the stomach wall, along with a system for adjusting the size of the volume filling device An alternative embodiment of an apparatus for doing so will now be described. The volume filling device is the inflatable device described above with reference to FIGS. 5a-h and thus contains fluid. Thus, the inflatable device 10 forms a fluid chamber in which fluid can flow. This allows the inflatable device to form an inflatable chamber that can change the volume occupied within the stomach wall, thereby forming an inflatable device that is hydraulically or pneumatically regulated.

  In FIG. 6a, the fluid injection port 16 is connected to the inflatable volume filling device 10 using a tube-shaped conduit 18. Thereby, the inflatable device 10 is adapted to be adjusted preferably non-invasively by moving liquid or air from the injection port 16 to a chamber formed by the inflatable device. By using a hypodermic needle or the like, the amount of fluid in the volume filling device 10 can be adjusted, thereby adjusting the size of the adjustable device. The injection port 16 can also be used simply to refill the volume filling device 10.

  The conditioning reservoir 17 can be adjusted in several ways. In an alternative embodiment, adjustment reservoir 17 is adjusted by manually squeezing adjustment reservoir. That is, the adjustment reservoir is adjusted by moving the wall of the reservoir. And it is preferable to place the regulation reservoir subcutaneously, thereby achieving non-invasive regulation.

  A similar embodiment is shown in FIG. However, in this embodiment, the injection port 16 is replaced by an adjustable adjustment reservoir 17 that fluidly connects with the volume filling device 10 via a tube 18. As the adjustment reservoir 17 is compressed, its volume decreases and hydraulic fluid moves from the reservoir to the chamber formed by the expandable device 10 via a conduit or tube 18 to expand or expand the expandable device 10. Let In this way, the volume filling device can be adjusted non-invasively after surgery.

  It should be understood that pneumatic operation can be used instead of hydraulic operation, where air instead of hydraulic fluid moves between the conditioning reservoir and the chamber formed by the inflatable device 10. Preferably, the adjustment reservoir has a locked position for maintaining it in the desired position. When the patient compresses the reservoir, preferably the reservoir remains in the compressed state and is released after being squeezed again.

  Any type of hydraulic method may be used for the inflatable device. The hydraulic method is mechanically driven and powered using any motor or pump and manually.

  In another embodiment shown in FIG. 7, the motor 40 is adapted to move the wall of the conditioning reservoir 17. A powered reservoir 17 is then preferably placed in the patient's abdominal cavity. In this embodiment, a wireless remote control unit that forms part of the vise 34 with external energy transfer can be provided for non-invasive adjustment of the motor via the energy conversion device 30, An energy consuming operating device (motor 40 in this example) is adapted to supply energy via the power supply line 32.

  The remote control may comprise a wireless energy transfer device, thereby making non-invasive adjustments with this energy transfer device. When adjusting remotely, an internal power supply is provided to power the adjustment device. An internal power source is, for example, an implanted rechargeable battery or capacitor or a device that receives wireless energy transmitted from outside the patient's body. Various methods of adjusting the inflatable device 10 are described below with reference to FIGS. 22-41.

  In a further alternative embodiment shown in FIG. 8, the apparatus for treating obesity comprises a pump 44, which pumps fluid or air from the reservoir into a chamber formed of an inflatable device, thereby causing the reservoir to Adjust. Various configurations of this pump are described below with reference to FIGS. 22-41.

  A further alternative embodiment of a device for treating obesity will now be described with reference to FIG. 9, which shows the stomach 12 of a patient being treated for obesity. This embodiment is similar to that described above with reference to FIG. 7 and the apparatus comprises a volume filling device in the form of an inflatable device 10 that is invaginated into the stomach wall 12a of the patient's stomach 12. However, in this case, the invagination is performed in the fundus, i.e. in the upper part of the stomach, the number of receptors in the stomach wall is large and the inflatable device functions as a traction device for a part of the stomach wall in the fundus To do.

  The fluid conditioning reservoir 17 is connected to the inflatable device using a tube-shaped conduit 18. Thereby, the expandable device 10 is preferably adapted to be adjusted non-invasively by moving liquid or air from the conditioning reservoir 17 to the chamber formed by the expandable device 10. Preferably, the adjustment of the inflatable device 10 comprises a reverse servo, i.e. a small volume is actuated, e.g. by the patient's finger, which is connected to a large volume, i.e. the adjustment reservoir 17.

  Accordingly, the inflatable device 10 is positioned outside the stomach wall and is adapted to pull a portion of the stomach wall at the fundus to affect the patient's appetite. Increasing the size of the traction device increases the circumference of the inflatable traction device 10 so that the gastric wall 12a of the fundus surrounding the inflatable traction device 10 is withdrawn. By this traction, the stomach wall receptors indicate that the stomach is full and create a feeling of fullness for the patient. Thus, when the traction device 10 is contracted, the receptor indicates that the stomach is not full, thereby reverting to a feeling of hunger. It should be understood that this embodiment combines the effects of both reducing the volume of the gastric food cavity and pulling a portion of the stomach wall, thereby increasing the therapeutic effect.

  Inflation and deflation of the traction device 10 can be performed by direct control by the patient. Instead, inflation and deflation can be performed according to a pre-programmed schedule.

  In the preferred embodiment shown in FIG. 10, the sensor 19 is provided at an appropriate position such as the esophagus. The volume filling device 10 in the form of an inflatable traction device is similar to that shown in FIG. By providing one or more sensors, the apparatus for treating obesity adjusts the size of the volume filling device 10 in the form of an inflatable traction device in response to the amount of food entering the gastric food cavity. Can be automated. This causes fluid to move between the inflatable volume filling device 10 and the fluid reservoir 15.

  A device for treating obesity can have the added functionality of treating reflux disease. An embodiment having this function is shown in FIG. 11a, where the volume filling device 10 penetrates into the stomach wall near and more at least partially above the patient's cardia 26 when the patient is standing, and is sutured or stapled. It is fixed at a position above the cardia region 26 by fixing means such as a clasp 14a. For example, direct or indirect fixation to diaphragm muscle or other muscle tissue may be provided. Alternatively, direct or indirect fixation to the esophagus can be provided at and near the His angle. In this alternative embodiment, the volume filling device 10 is placed in place with respect to the gastric wall of the fundus when implanted to fill the volume above the cardia region 26 between the cardia and the diaphragm muscle. Prevents cardia from sliding up into the chest cavity and preventing reflux disease.

  In this preferred embodiment, an apparatus for treating both reflux and obesity comprises two or more motion restriction device segments adapted to form a motion restriction device 310. In this embodiment, there are a plurality of spherical motion limiting device segments in the form of small balls, which are included in the motion limiting device segments in the form of an outer layer or shell, preferably elastic or flexible. In this way, the outer layer can be inserted into the stomach as a separate part, which is later filled with a plurality of small, preferably spherical or polyhedral, motion limiting device segments. This method is described below with reference to FIGS. 59a-c.

  By providing a motion restriction device 310 having a plurality of motion restriction device segments, the motion restriction device 310 easily adapts to the stomach movements it invades.

  In an alternative embodiment, a small motion restriction device segment is inserted or infused into a sac that has already been created in a portion of the patient's stomach wall, and there is no collection outer layer or shell. This embodiment is illustrated in FIG. 11b and corresponds to the method described below with reference to FIGS. 59a-c.

  In order to provide a more stable motion restriction device at the proximal portion 310 ', this portion can be made in a different configuration than the distal portion 310 ". Thus, in the embodiment shown in FIG. 11e, the proximal portion 310 ′ fixed in the upper position of the cardia region 14c comprises a large ball-shaped portion or segment, and the distal portion 310 ″ has a plurality of small movements. With a restricted device segment. This embodiment includes a stable proximal portion 310 ′ used to prevent reflux disease and a more flexible distal portion 310 ″ used as a volume filling device to treat obesity. Combine the benefits of In general, the proximal and distal portions can have different configurations and contents, independent of each other. This content can be a solid content and a fluid content, for example a mixture of friction increasing or decreasing fluid.

  Such volume filling device 10 may be used to maintain electronics and / or energy sources and / or hydraulic fluid. The hydraulic fluid from this device may be distributed into several smaller inflatable device areas, thereby changing the traction area from time to time and creating a more permanent traction effect on the stomach wall that may occur. To avoid. Several traction areas may be used mechanically.

  In the alternative embodiment shown in FIG. 12, the volume of the inflatable volume filling device 10 may be fluidly connected to one or more, preferably smaller, inflatable devices or chambers 50. These chambers are adapted to move fluid or air moving between the chambers.

  Thus, the larger chamber 10 is adapted to become a volume filling device, depending on the major part of its volume, to reduce the size of the food cavity and to treat reflux disease, one or several The small chamber is adapted to function as an inflatable device for treating obesity, where the main chamber is adapted to move fluid or air into the small chamber, which is the traction effect of the stomach wall and thus Bring about the treatment of obesity.

  13-16 illustrate various embodiments that provide a combination of a volume filling device invaginated in the middle or lower part of the stomach with a traction device invaginated in the upper or lower stomach of the patient. . Accordingly, FIG. 13 shows the adjustable volume filling device 10 invaginated in the stomach wall of the patient's stomach 12. Moreover, an adjustable traction device 50 having the effects already described is invaginated in the stomach wall of the patient's stomach. The volume filling device 10 is preferably substantially larger than the traction device 50.

  The volume filling device 10 and the traction device 50 are in fluid communication with each other via a fluid communication device comprising a first fluid tube 52 provided with a pump 54. Pump 54 is under control from energy conversion device 30 adapted to supply energy to pump 54 via power supply line 56. The energy conversion device 30 is also connected to a sensor 19 provided in the patient's esophagus that can detect eating.

  Also, the volume filling device 10 and the traction device 50 are in fluid communication with each other via a second fluid tube 58 that preferably has a smaller cross-sectional area than the first fluid tube 52.

  The operation of this arrangement is as follows. The volume filling device 10 functions as in the above-described embodiment, i.e., reduces the size of the food cavity of the patient's stomach 12. In addition, the traction device 50 is expanded by pushing fluid from the volume filling device 10 to the traction device 50 using the pump 54, and the gastric wall of the fundus is pulled, creating a feeling of satiety for the patient. Thus, for example, if eating is detected using sensor 19, fluid is automatically pushed to traction device 50 to increase satiety and thereby limit eating.

  When fluid is injected into the traction device 50, the internal pressure of the traction device 50 is higher than the internal pressure of the volume filling device 10. This pressure difference creates a fluid flow from the traction device 50 to the volume filling device 10, preferably in the narrower second tube 58. The flow rate is determined, inter alia, by the pressure difference and the cross-sectional area of the second tube 58. The second tube is preferably sized so that the pressure in volume filling device 10 and traction device 50 returns to equilibrium three hours after fluid is injected into traction device 50 to create a feeling of fullness. .

  In this embodiment, the function of the second tube 58 is to allow fluid to return from the traction device 50 to the volume filling device 10. It should be understood that this yesterday can also be performed by the pump 54 in the first tube 52 and that the second tube 58 can be eliminated.

  FIG. 14 shows an embodiment similar to that shown in FIG. Accordingly, an adjustable volume filling device 10 is provided that is invaginated into the stomach wall of the patient's stomach 12. Moreover, an adjustable traction device 50 having the functions already described is invaginated into the stomach wall of the patient's stomach. The volume filling device 10 is preferably substantially larger than the traction device 50.

  The volume filling device 10 and the traction device 50 are in fluid communication with each other via a first fluid tube 52 and a second fluid tube, preferably having a smaller cross-sectional area than the first tube. However, the first tube 52 is provided with a backflow prevention valve 60 instead of the pump supplied with energy. With this backflow prevention valve, fluid flows from the volume filling device 10 to the traction device 50, but cannot flow in the reverse direction. This means that this embodiment may be completely energy-free. Instead, this embodiment operates on the following principle.

  When the food cavity of the stomach 12 is essentially empty, there is an equilibrium between the internal pressures of the volume filling device 10 and the traction device 50. In this state, the traction device is in a non-traction state, i.e., it does not generate a feeling of fullness by pulling part of the stomach wall at the fundus.

  As the patient begins to eat, food enters the food cavity of the stomach 12. Thereby, the pressure to the stomach wall in which the volume filling device 10 is invaded increases, and the internal pressure of the volume filling device 10 increases. Also, gastric wall muscles begin to process food in the food cavity by contraction, which also contributes to an increase in internal pressure of the volume filling device 10.

  Because the traction device 50 is located at the top of the stomach 12 where food does not apply pressure to the stomach wall, the internal pressure of the traction device 50 remains essentially unchanged, and thus from the volume filling device 10 to the traction device 50. A fluid flow is generated through the first and second fluid tubes 52, 58 in the direction toward. As a result, the volume of the traction device 50 increases, and the traction device 50 pulls the stomach wall at the bottom of the stomach to give the patient a feeling of fullness.

  The flow of fluid through the second tube 58 from the traction device 50 to the volume filling device 10 returns the pressure of these devices to equilibrium as described above with reference to FIG.

  FIG. 15 shows an embodiment similar to that shown in FIG. 14, but used to refill a fluid system comprising a volume filling device 10 and a traction device 50, or alternatively, the size of the fluid system. An inflow port 16 is added which is used to actively adjust the.

  Similarly, FIG. 16 shows an embodiment similar to that shown in FIG. 9 in which the traction device 50 can be actively adjusted by manually squeezing a conditioning reservoir placed under the patient's skin. Thus, the fluid conditioning reservoir 17 is connected to the inflatable device using a tube-shaped conduit 18. Thereby, the traction device is adapted to be adjusted non-invasively by moving liquid or air from the conditioning reservoir 17 to a chamber formed of an inflatable device. Preferably, the adjustment of the traction device 50 includes a reverse servo, i.e. a small volume is actuated, e.g. with the patient's finger, and this small volume is connected to a larger volume.

  An alternative positioning of the volume filling device 10 is shown in FIGS. 17a and 17b, where FIG. 17b shows a cross-sectional view of the stomach shown in FIG. 17a at line XVIIb-XVIIb. The volume filling device 10 is adapted to be placed inside the stomach wall of the stomach 12, such as through an endoscope or similar intraluminal device, and rests against the stomach wall 12a. The inflatable device can be maintained invaginated using stitching or stapling 14, as in the embodiment of FIGS. 2a and 2b. In this embodiment, no hole is required in the stomach wall. Instead, the method of providing the volume filling device 10 can include the following steps described with reference to FIGS. 18a-i showing the invagination device.

  The invagination device, generally designated 630, includes an elongated tube member 632 similar to the elongated member 607 described above with reference to FIGS. 5a-i. Thus, it can be connected to the control unit 606 as shown in FIG. The invagination device 630 further comprises a preferably elongated, perforated suction portion 634. The suction portion 634 has a plurality of small holes 636, and air is sucked into these small holes by performing suction on the tube member 632. Using this suction effect, a “pocket” or “sac-like portion” is generated in a portion of the stomach wall generally represented by 12a.

  In other words, as shown in FIG. 18a, when the tip of the suction portion 634 is pressed against the stomach wall 12a, a small recess is formed there. As shown in FIG. 18b, when the suction portion 634 is further pressed against the stomach wall 12a, a larger recess is formed. The portion of the stomach wall 12a that forms the recess adheres to the suction portion 634 of the invagination device 630 by the suction effect. As shown in FIG. 18c, when the suction portion 634 is further pressed against the stomach wall 12a, a deeper recess is formed until the entire suction portion 634 is embedded in the recess as shown in FIG. 18d.

  As shown in FIG. 18e, the edge of the recess is fixed with the fixing element 638 at this stage and the suction part is removed from the instrument. Subsequently, as shown in FIG. 18f, the compressed elastic volume filling device 10 is inserted into the recess, for example, in the manner described above with reference to FIG. 4d. Next, the compressed volume filling device is expanded to its final shape, as shown in FIG. 18g, and then the sac is sutured or stapled with a securing element as shown in FIG. 18h. Seal.

  All alternatives described above with reference to FIGS. 2-16 are also applicable to the embodiment described with reference to FIGS. 17 and 18, ie, the volume filling device is invaginated inside the stomach wall. It is.

  FIGS. 19 a-j show the instrument used in the method of engaging the volume filling device 10 with the stomach wall 12 of the patient. This instrument is adapted to be inserted through a thin tube shaped object, such as an endoscope used in an intracavitary procedure or a laparoscopic trocar used in a laparoscopic procedure. The device comprises an elongate member 650 adapted to be flexible using a structure comprising a plurality of ring-shaped members, wherein the elongate member 650 is flexible or adjustable. It is conceivable to make it flexible by making it from a material. The elongate member 650 is inserted into the body and placed from the outside or inside of the patient's stomach wall 12 in the vicinity thereof. The elongate member 650 has a special retention device 651 adapted to hold the stomach using a mechanical grasping member or vacuum. The special holding device 651 has a first joint 652 and a second joint 653 that allow the special holding device 651 to be manipulated relative to the elongated member 650, thereby providing a mechanical gripping means or vacuum. A portion of the holding device 651 comprising the element is placed in contact with the stomach wall 12 of the patient. FIG. 19b shows a special holding device 651 when placed in contact with the stomach wall 12 of a human patient, after which a special holding member 651 is connected to the stomach wall to hold the gastric wall 12. FIG. 19 c shows this instrument when performing the step of advancing the push rod 654 from the elongate member 650. The push rod 654 pushes the stomach wall 12 to create a cavity or sac. FIG. 19d shows the device in a state rotated 90 ° with respect to FIGS. 19a-c. This figure shows a special holding member that is operably attached to the two sides of the elongate member 650 and holds the gastric wall 12 when it is pushed against the gastric wall 12 and pushes the push rod 654 to create a cavity or sac. 651a and b are shown. When the push rod 654 pushes the stomach wall 12 to the desired position, the special holding device 651a, b moves toward the push rod 654 and closes the cavity or sac.

  Once the cavity or sac is created, it must be sealed. FIG. 19 f shows the suturing or stapling device 655 being advanced from the elongate member 650. A suturing or stapling device 655 is placed in connection with the stomach wall, after which the suturing or stapling device initiates suturing or stapling of the stomach wall 12 and sealing the suturing or stapling 14 between the stomach and stomach. Is generated. The device is moved along the stomach wall 12 of the patient, thereby creating a cavity or sac and sealing with the device, as shown in FIGS. 19g and 19h. Once the desired size cavity or sac is created and sealed, the insertion member 656 is advanced from the elongate member 650. The insertion member 656 is adapted to insert an inflatable volume filling device as previously described in this application. After the insertion member 656 is placed in the cavity or sac, the pressurized fluid or gas or a mechanical advancement member that pushes the expandable volume filling device 10 into the cavity or sac is used to Through the insertion member 656 and into the cavity or sac. The insertion member then inflates the expandable volume filling device with fluid or gas and seals the final portion of the sac using sutures or stapling 14 between the stomach and stomach. While the embodiments described herein describe a process for inserting an inflatable volume filling device, the volume filling device 10 may be made inflatable by making the volume filling device 10 from an elastic material. Equally considered.

  FIGS. 20a-f show the instrument used in the method of engaging the volume filling device 10 to the stomach wall 12 of a patient. This instrument is adapted to be inserted through a thin tube shaped object, such as an endoscope used in an intracavitary procedure or a laparoscopic trocar used in a laparoscopic procedure. The device comprises an elongate member 660 adapted to be flexible using a structure comprising a plurality of ring-shaped members, the elongate member 660 being flexible or adjustable. It is conceivable to make it flexible by making it from a material. The elongate member 660 is inserted into the body and placed from the outside or inside of the patient's stomach wall 12 in the vicinity thereof. The elongate member 660 has a special holding device 661 adapted to hold the stomach using a mechanical grasping member or vacuum. The special holding device 661 is locked in position with the elongated member 660 using a locking ring 662. A special holding device is made of an end of flexible material that is pre-bent to expand into a funnel-shaped device upon removal of the locking ring 662. FIG. 20b shows a special holding device inflated in a funnel shape. FIG. 20 b further shows a special holding device 661 when placed in contact with the stomach wall 12 of the human patient, after which the special holding device 661 connects to the gastric wall 12 to hold the gastric wall 12. FIG. 20 c shows this device when performing the step of advancing push rod 664 from elongate member 660. Push rod 664 pushes stomach wall 12 to create a cavity or sac. When the push rod 664 pushes the stomach wall 12 to the desired position, the special holding device 661a, b moves towards the push rod 664 and closes the cavity or sac.

  Once the cavity or sac is created, it must be sealed. FIG. 20 d shows the suturing or stapling device 665 being advanced from the elongate member 660. A suturing or stapling device 665 is positioned to connect with the stomach wall 12, after which the suturing or stapling device 665 initiates suturing or stapling of the stomach wall 12 and the suturing or stapling 14 between the stomach and stomach. Create a seal. Thereafter, the insertion member 666 is advanced from the elongate member 660 and the special holding device 661 is retracted. The insertion member 666 is adapted to insert the expandable volume filling device 10 as previously described in this application. After the insertion member 666 is placed in the cavity or sac, the pressurized fluid or gas or mechanical advancement member that pushes the expandable volume filling device 10 into the cavity or sac is used to Through the insertion member 666 and into the cavity or sac. The insertion member 666 then inflates the expandable volume filling device with fluid or gas and seals the final portion of the sac using sutures or stapling 14 between the stomach and stomach. While the embodiments described herein describe a process for inserting an inflatable volume filling device, the volume filling device 10 may be made inflatable by making the volume filling device 10 from an elastic material. Equally considered. FIG. 20f shows the volume filling device 10 with the volume filling device 10 invaginated in the stomach wall 12 and within a cavity or pouch sealed with a suture or stapling 14 between the stomach and stomach.

  FIG. 21 shows an instrument for use in a method of engaging a volume filling device according to any embodiment of the present application with the stomach wall 12. The device includes an elongate member 670 adapted to be flexible using a structure comprising a plurality of ring-shaped members, the elongate member 670 being flexible or adjustable. It is conceivable to make it flexible by making it from a simple material. The elongate member 670 is inserted into the body and placed from the inside of the patient's stomach wall 12 in the vicinity thereof. A gastric piercing member 672 is positioned at the distal end of the elongate member 670 and is retractable into a protective sleeve 673 adapted to protect human tissue from the sharp piercing member 670 or cutter 672 after performing a cutting operation. Fix it.

  FIG. 21 b shows the device with the elongated member 670 after performing the cutting operation and retracting the gastric piercing member or cutter 672 into the protective sleeve 673. The guide wire is pushed through the slot made in the elongate member 670, stomach wall 12 and out through the abdominal cavity and placed inside the patient's skin, the skin from the outside so that the guide wire 671 can exit the abdominal cavity. It is penetrated. The guide wire 671 can then be used to guide the conduit 18 or lead attached to the volume filling device 10 and place it from the inside into the stomach. The volume filling device 10 having a conduit 18 or electronic lead may be a volume filling device 10 according to any of the embodiments of the present application. By guiding the conduit 18 or electronic lead, the conduit 18 or electronic lead can be attached to the control unit 42 placed under the skin of the patient from outside the abdominal cavity.

  FIG. 22 shows a system for treating a disease comprising apparatus 10 comprising a volume filling device of the present invention placed in the abdominal cavity of a patient. The implanted energy conversion device 1002 is adapted to supply energy via the power supply line 1003 to the energy consuming components of the apparatus. An external energy transfer device 1004 for non-invasively supplying energy to the apparatus 10 transmits energy by at least one wireless energy signal. Implanted energy conversion device 1002 converts energy from wireless energy signals to electrical energy, which is supplied via power supply line 1003.

  The implanted energy conversion device 1002 may also include other components such as: a coil for receiving and / or transmitting signals and energy, and an antenna for receiving and / or transmitting signals. A charge control unit optionally comprising an energy storage device such as a microcontroller, a capacitor, one or more sensors such as a temperature sensor, a pressure sensor, a position sensor, a motion sensor, a transceiver, optionally a motor including a motor controller, a pump, and Other parts for controlling the operation of medical implants.

  The wireless energy signal may include a waveform signal selected from: a sound wave signal, an ultrasonic signal, an electromagnetic wave signal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal, a radio signal. X-ray irradiation signal and gamma-ray irradiation signal. Alternatively, the wireless energy signal may include an electric or magnetic field or a combination of electric and magnetic fields.

  The wireless energy transfer device 1004 may transmit a carrier signal that carries a wireless energy signal. Such a carrier signal may include a digital signal, an analog signal, or a combination of digital and analog signals. In this case, such carrier signals include analog signals or digital signals or a combination of analog and digital signals.

  Generally speaking, the energy conversion device 1002 converts the first form of wireless energy transmitted by the energy transfer device 1004 into a second form of energy, typically different from the first form of energy. To be provided. The implanted device 10 is operable in response to the second form of energy. When the energy conversion device 1002 converts the first form of energy transmitted by the energy transfer device 1004 to the second form of energy, the energy conversion device 1002 directly powers the apparatus with the second form of energy. Can do. The system may further comprise an implantable accumulator, and the second form of energy is used to charge the accumulator at least in part.

  Alternatively, the wireless energy transmitted by the energy transfer device 1004 may be used to power the apparatus directly while the energy transfer device 1004 is transmitting wireless energy. The system includes an operating device for operating the apparatus, as described below, for directly powering the operating device and operating the apparatus using the wireless energy transmitted by the energy transfer device 1004 Kinetic energy may be generated.

  The first form of wireless energy may include sound waves, and the energy conversion device 1002 may include a piezoelectric element for converting sound waves into electrical energy. The second form of energy may include electrical energy in the form of direct current or pulsating direct current or a combination of direct current and alternating current. Typically, the device comprises electronic components that are energized with electrical energy. Another implantable electronic component of the system is at least one voltage level guard or at least one constant current guard connected to the electronic component of the device.

  Optionally, one of the first form energy and the second form energy comprises magnetic energy, kinetic energy, acoustic energy, chemical energy, radiant energy, electromagnetic energy, optical energy, nuclear energy or thermal energy. May include. Preferably, one of the first form energy and the second form energy is not magnetic energy, kinetic energy, chemical energy, acoustic energy, nuclear energy or thermal energy.

  The energy transfer device may be operated from outside the patient's body to emit electromagnetic wireless energy, which is used for operation of the device. Alternatively, the energy transfer device is operated from outside the body to release non-magnetic wireless energy, and the released non-magnetic wireless energy is used to operate the apparatus.

  The external energy transfer device 1004 also includes a wireless remote control having an external signal transmitter that transmits a wireless control signal for non-invasive control of the apparatus. The control signal is received at the implanted signal receiver, which may be incorporated into the implanted energy conversion device 1002 or may be separate therefrom.

  The radio control signal may include a frequency, amplitude, or phase modulation signal, or a combination thereof. Alternatively, the wireless control signal includes an analog signal or a digital signal or a combination of analog and digital signals. Alternatively, the wireless control signal includes an electric or magnetic field or a combination of electric and magnetic fields.

  The wireless remote control may transmit a carrier signal that carries a wireless control signal. Such a carrier signal may include a digital signal, an analog signal, or a combination of digital and analog signals. Where the control signal includes an analog signal or a digital signal or a combination of analog and digital signals, the wireless control signal preferably carries an electromagnetic carrier signal that carries the digital control signal or analog control signal.

  FIG. 23 shows the system of FIG. 22 in the form of a more generalized block diagram showing the apparatus 10, an energy conversion device 1002 that powers the apparatus 10 via a power supply line 1003, and an external energy transfer device 1004. The patient's skin 1005, generally indicated by a vertical line, separates the patient's interior on the right side of this line and the patient's exterior on the left side.

  FIG. 24 shows the same book as the embodiment of FIG. 23 except that a reversing device, for example in the form of an electronic switch 1006 that can be operated with polarized energy, is also implanted in the patient to reverse the apparatus 10. 1 illustrates an embodiment of the invention. When operating this switch with polarized energy, the wireless remote control of the external energy transfer device 1004 transmits a radio signal carrying the polarized energy, and the implanted energy conversion device 1002 is polarized wireless energy. Into a polarized current for operating the electronic switch 1006. When the polarity of the current is changed in the implanted energy conversion device 1002, the electronic switch 1006 reverses the function performed by the device 10.

  FIG. 25 is the same as the embodiment of FIG. 23 except that an operating device 1007 that is implanted in the patient to operate the apparatus 10 is provided between the implanted energy conversion device 1002 and the apparatus 10. Embodiment of this invention is shown. This operating device can be in the form of a motor 1007 such as an electronic servo motor. The motor 1007 is powered with energy from the implanted energy conversion device 1002 because the remote control of the external energy transfer device 1004 transmits a wireless signal to the receiver of the implanted energy conversion device 1002.

  FIG. 26 shows an embodiment of the present invention that is identical to the embodiment of FIG. 23 except that the operating device is in the form of an assembly 1008 that includes a motor / pump unit 1009 and the fluid reservoir 1010 is implanted in the patient. Show. In this case, the device 10 is hydraulically operated, i.e., hydraulic fluid is pushed from the fluid reservoir 1010 through the conduit 1011 to the device 10 by the motor / pump unit 1009 to operate the device, and the device is returned to the starting position. For this purpose, hydraulic fluid is pushed from the device 10 to the fluid reservoir 1010 by the motor / pump unit 1009. Implanted energy conversion device 1002 converts wireless energy into a current, eg, a polarized current, for powering motor / pump unit 1009 via power supply line 1012.

  Instead of the hydraulically operated device 10, it can also be assumed that the operating device comprises a pneumatic operating device. In this case, the hydraulic fluid can be pressurized air used for regulation, replacing the fluid reservoir with an air chamber.

  In all of these embodiments, the energy conversion device 1002 may include a rechargeable accumulator, such as a battery or capacitor that can be charged with wireless energy, to supply energy to any energy consuming component of the system. .

  Alternatively, the above-described wireless remote control can be replaced with manual control of any implanted part so that it touches the push button placed in the patient's hand, most often indirectly, for example under the skin. It's okay.

  FIG. 27 comprises an external energy transfer device 1004 with wireless remote control, in this case a hydraulically operated device 10 and an implanted energy transfer device 1002, and a hydraulic fluid reservoir 1013, motor / pump unit 1009, And an embodiment of the present invention further comprising a reversing device in the form of a hydraulic valve shift device 1014, all of which are implanted in the patient. Of course, the hydraulic operation can be easily performed simply by changing the pumping direction, so the hydraulic valve may be eliminated. The remote control may be separate from or included in the external energy conversion device. The motor of the motor / pump unit 1009 is an electronic motor. In response to a control signal from the wireless remote control of the external energy transfer device 1004, the implanted energy conversion device 1002 powers the motor / pump unit 1009 with energy from the energy carried by the control signal, thereby The motor / pump unit 1009 disperses the hydraulic fluid between the hydraulic fluid reservoir 1013 and the device 10. Remote control of the external energy transfer device 1004 controls the hydraulic valve shift device 1014 to control the direction in which fluid is pushed from the hydraulic fluid reservoir 1013 to the device 10 by the motor / pump unit 1009 to operate the device. To return to the starting position, the direction of hydraulic fluid flow is shifted between the opposite direction in which fluid is pushed back from the device 10 to the hydraulic fluid reservoir 1013 by the motor / pump unit 1009.

  FIG. 28 shows an external energy transfer device 1004 with wireless remote control, and in this case a hydraulically operated device 10, implanted energy conversion device 1002, controlled by wireless remote control of external energy transfer device 1004. FIG. 6 shows an embodiment of the present invention comprising an internal control unit 1015 configured, an implanted accumulator 1016, and an implanted capacitor 1017. FIG. The internal control unit 1015 forms a storage device for electrical energy received from the implanted energy conversion device 1002 of the accumulator 1016 and supplies energy to the device 10. In response to a control signal from the wireless remote control of the external energy transfer device 1004, the internal control unit 1015 releases electrical energy from the accumulator or 1016 and transmits the released energy via power lines 1018 and 1019. In order to operate the apparatus 10, the electrical energy from the implanted energy conversion device 1002 is directly converted via the power line 1020, the current stabilizing capacitor 1017, the power line 1021 and the power line 1019.

  Preferably, the internal control unit is programmable from outside the patient's body. In a preferred embodiment, the internal control unit adjusts the device 10 according to a pre-programmed time schedule or according to input from any sensor that senses any possible physical parameter of the patient or any functional parameter of the system. In order to be programmed.

  According to an alternative embodiment, the capacitor 1017 of the embodiment of FIG. 28 may be omitted. According to another alternative embodiment, the accumulator 1016 of this embodiment may be deleted.

  FIG. 29 is the same as the embodiment of FIG. 23 except that a battery 1022 for supplying energy for operation of the device 10 and an electronic switch 1023 for switching operation of the device 10 are also implanted in the patient. The embodiment of this invention is shown. The electronic switch 1023 may be operated remotely and may be operated with the energy provided by the implanted energy conversion device 1002 so that the battery 1022 is in the device from an off mode that does not use the battery 1022. Switch to on mode to supply energy for 10 operations.

  FIG. 30 shows an embodiment of the invention that is identical to the embodiment of FIG. 29 except that an internal control unit 1015 that can be controlled by wireless remote control of the external energy transfer device 1004 is also implanted in the patient. In this case, the electronic switch 1023 is operated with the energy supplied by the implanted energy conversion device 1002, and the remote control is internally controlled from the off mode where the wireless remote control does not control the internal control unit 1015 and does not use the battery. Switch to standby mode, where unit 1015 is allowed to control and battery 1022 supplies energy for operation of device 10.

  FIG. 31 shows an embodiment of the present invention that is identical to the embodiment of FIG. 30 except that an accumulator 1016 is used instead of the battery 1022 and the implanted components are interconnected in a different manner. In this case, accumulator 1016 stores energy from implanted energy conversion device 1002. In response to a control signal from the wireless remote control of the external energy transfer device 1004, the internal control unit 1015 controls the electronic switch 1023, and from the off mode where the accumulator 1016 is not used, the accumulator 1016 is energized for operation of the device 10. Switch to on mode to supply. The accumulator may be combined with a capacitor or replaced with a capacitor.

  FIG. 32 shows an embodiment of the present invention that is identical to the embodiment of FIG. 31 except that the battery 1022 is also implanted in the patient and the implanted components are interconnected in different ways. In response to a control signal from a wireless remote control of external energy transfer device 1004, internal control unit 1015 controls accumulator 1016 to deliver energy for operating electronic switch 1023, and from an off mode that does not use battery 1022. The battery 1022 switches to an on mode that supplies energy for operation of the device 10.

  Alternatively, the electronic switch 1023 is operated with the energy supplied by the accumulator 1016, avoiding wireless remote control to control the battery 1022 to supply electrical energy, and from a battery-free off mode to wireless remote control. Control switches to standby mode, where the battery 1022 is controlled and allowed to supply electrical energy for operation of the device 10.

  It should be understood that switch 1023 and all other switches in this application are to be understood in their broadest embodiments. This means a transistor, MCU, MCPU, ASIC, FPGA or DA converter, or any other electronic component or circuit that can be turned on and off. Preferably, the switch is controlled from outside the body, or alternatively is controlled by an implanted internal control unit.

  FIG. 33 is identical to the embodiment of FIG. 29 except that a motor 1007, a mechanical reversing device in the form of a gear box 1024, and an internal control unit 1015 for controlling the gear box 1024 are also implanted in the patient. 1 illustrates an embodiment of the present invention. The internal control unit 1015 controls the gearbox 1024 and reverses the function performed by the device 10 (mechanically operated). A simple method is to electrically reverse the direction of the motor. The gearbox, interpreted in the broadest embodiment, means a servo configuration that saves power for the operating device, as it is advantageous to operate with longer strokes.

  FIG. 34 shows an embodiment of the present invention that is identical to the embodiment of FIG. 40 except that the implanted components are interconnected in a different manner. Thus, in this case, the internal control unit 1015 is powered by the battery 1022 when the accumulator 1016, suitably a capacitor, activates the electronic switch 1023 to switch to the on mode. When the electronic switch 1023 is in the on mode, the internal control unit 1015 is allowed to control the battery 1022 to supply or not supply energy for operation of the device 10.

  FIG. 35 schematically illustrates possible combinations of implanted device components to achieve various connection options. Basically, there is an external energy transfer device 1004 that includes apparatus 10, internal control unit 1015, motor or pump unit 1009, and external wireless remote control. As already mentioned above, the wireless remote control communicates control signals received by the internal control unit 1015 and controls the various implanted components of the device.

A feedback device, preferably comprising a sensor or measurement device 1025, may be implanted in the patient to sense the patient's physical parameters. The physical parameter is at least one parameter selected from the group consisting of pressure, volume, diameter, traction, stretching, stretching, movement, flexion, elasticity, muscle contraction, nerve shock, body temperature, blood pressure, blood flow, heart rate and respiration. It may be. The sensor may sense any of the physical parameters described above. For example, the sensor may be a pressure sensor or a motility sensor. Alternatively, sensor 1025 may be arranged to sense a functional parameter. The functional parameters may correlate with the conversion of energy to charge the implanted energy source and may further include at least one parameter selected from the group of parameters consisting of: power, any Electronic parameters, pressure, volume, diameter, traction, stretching, stretching, moving, bending, elasticity, temperature, and flow.

  The feedback may be sent to the internal control unit or may be sent to the external control unit, preferably via the internal control unit. The feedback may be sent out of the body via an energy conversion system or a separate communication system having a receiver and a transmitter.

  Internal control unit 1015, or alternatively, external wireless remote control of external energy transfer device 1004 may control apparatus 10 in response to a signal from sensor 1025. The transceiver may be combined with the sensor 1025 to send information about the sensed physical parameter to an external wireless remote control. The wireless remote control may comprise a signal transmitter or transceiver and the internal control unit 1015 may comprise a signal receiver or transceiver. Alternatively, the wireless remote control may comprise a signal receiver or transceiver and the internal control unit 1015 may comprise a signal transmitter or transceiver. Using the transceivers, transmitters and receivers described above, information or data regarding the device 10 may be transmitted from the patient's body to the body.

  When the motor / pump unit 1009 and the battery 1022 for supplying power to the motor / pump unit 1009 are transplanted, information regarding charging of the battery 1022 may be fed back. More precisely, when charging a battery or accumulator with energy, feedback information about the charging process is transmitted and the energy supply is changed accordingly.

  FIG. 36 shows an alternative embodiment for adjusting the device 10 from outside the patient's body. System 1000 includes a battery 1022 connected to device 10 via a subcutaneous electronic switch 1026. Therefore, by manually pressing the subcutaneous switch, the adjustment of the device 10 is performed non-invasively, thereby switching the operation of the device 10 on and off. It should be understood that the illustrated embodiment is simplified and that additional components such as an internal control unit or any other component disclosed in this application can be added to the system. Two subcutaneous switches may be used. In a preferred embodiment, one implanted switch sends information to the internal control unit to perform some predetermined function, which is reversed when the patient presses the switch again.

  FIG. 37 illustrates an alternative embodiment in which the system 1000 includes a hydraulic fluid reservoir 1013 that is hydraulically connected to the device. Non-invasive adjustment is performed by manually squeezing a hydraulic fluid reservoir connected to the device. Alternatively, the hydraulic fluid reservoir 1013 is preferably adapted to serve for injecting hydraulic fluid with the injection port for hydraulic fluid calibration.

  The system may include an external data communication device and a portable internal data communication device in communication with the external data communication device. The internal data communication device provides data regarding the device or patient to the external data communication device and / or the external data communication device provides data to the internal data communication device.

  FIG. 38 is an implant that transmits information from within the patient's body to outside the body to provide feedback information regarding at least one functional parameter of the device or system, or regarding the physical parameters of the patient, thereby consuming energy of the device 10. 1 schematically illustrates the configuration of a system capable of supplying an accurate amount of energy to an implanted internal energy receiver connected to a particular component. Such an energy receiver 1002 may include an energy source and / or an energy conversion device. Briefly, wireless energy is transmitted from an external energy source 1004a located outside the patient's body and received by an internal energy receiver 1002 located inside the patient's body. The internal energy receiver is adapted to supply received energy, directly or indirectly, via switch 1026 to the energy consuming component of device 10. The energy balance is determined between the energy received by the internal energy receiver 1002 and the energy used by the device 10, and the transmission of wireless energy is controlled based on the determined energy balance. Thus, the energy balance provides an accurate indication of the correct amount of energy required, which is sufficient to operate the device 10 properly but causes excessive temperature rise. There is no such thing.

  In FIG. 38, the patient's skin is indicated by a vertical line 1005. Here, the energy receiver comprises an energy conversion device 1002 located in the patient's body, preferably just below the patient's skin 1005. Generally speaking, the implanted energy conversion device 1002 may be placed in the abdominal cavity, throat, muscle bundle (eg, in the abdominal wall), subcutaneous, or any other suitable location. The implanted energy conversion device 1002 is a wireless energy E transmitted from an external energy source 1004a located in an external energy transmission device 1004 outside the patient's skin 1005 located in the vicinity of the implanted energy conversion device 1002. Adapted to receive

As is known in the art, wireless energy E generally includes a main coil disposed in external energy source 1004a and a secondary coil disposed adjacent to the main coil disposed in implanted energy conversion device 1002. The conversion may be performed using any suitable transdermal energy conversion (TET) device, such as a containing device. Supplying current through the main coil induces energy in the form of a voltage in the secondary coil, for example after storing the incoming energy in an implanted energy source such as a rechargeable battery or capacitor, It can be used to power implanted components that consume the energy of the device. However, the present invention is generally not limited to any particular energy conversion technology. A TET device or energy source and any type of wireless energy may be used.

  The amount of energy received by the implanted energy receiver may be compared to the energy used by the implanted components of the device. Here, the term “energy used” is understood to also include the energy stored by the implanted components of the device. The control device includes an external control unit 1004b that controls the external energy source 1004a based on the determined energy balance and adjusts the amount of energy converted. To convert the correct amount of energy, the energy balance and energy requirements are determined using a decision device that includes an implanted internal control unit 1015 connected between the switch 1026 and the apparatus 10. The internal control unit 1015 measures various measurements obtained by appropriate sensors (not shown), which measure certain features of the device 10, which in some way reflect the amount of energy required for proper operation of the device 10. It may be arranged for receiving. In addition, an appropriate measurement device or sensor may be used to sense the patient's current condition to provide parameters that reflect the patient's condition. Thus, such and / or parameters are related to the current state of the device 10, such as power consumption, operating mode and temperature, and the patient's condition reflecting parameters such as body temperature, blood pressure, heart rate and respiration. You can do it. Other types of patient physical parameters and device functional parameters are described elsewhere.

Further, an energy source in the form of an accumulator 1016 may optionally be connected to the implanted energy conversion device 1002 via the control unit 1015 to store received energy for later use by the apparatus 10. it can. Alternatively or additionally, the characteristics of such an accumulator may be measured as well, which also reflects the amount of energy required. The accumulator may be replaced with a rechargeable battery, and the measured characteristic may be any electrical parameter, such as energy consumption voltage, temperature, etc., related to the current state of the battery. In order to provide sufficient voltage and current to the apparatus 10 and to avoid excessive temperature rise, the correct amount of energy, i.e., neither too much nor too little, is transferred from the implanted energy conversion device 1002. It is clearly understood that the battery should be optimally charged by receiving the energy. The accumulator may also be a capacitor with corresponding characteristics.

  For example, the characteristics of the battery may be measured based on normal criteria for determining the current state of the battery, which is then stored in the appropriate storage means of the internal control unit 1015 as information about the state. It's okay. Thus, whenever a new measurement is made, the stored battery status information can be updated accordingly. In this way, battery information can be “calibrated” by converting the correct amount of energy to maintain the optimal state of the battery.

  Thus, the internal control unit 1015 of the decision device is controlled by the sensor or measurement device of the apparatus 10, or of the patient, or of this energy source, if used, or any combination thereof. Based on the measurements made, it is adapted to determine the energy balance and / or the current need for energy (energy per unit time or stored energy). The internal control unit 1015 is further connected to an internal signal transmitter 1027 which is arranged to transmit a control signal reflecting the determined energy requirement to an external signal receiver 1004c connected to the external control unit 1004b. Thus, the amount of energy transmitted from the external energy source 1004a may be adjusted according to the received control signal.

  Alternatively, the determination device may include an external control unit 1004b. In this alternative embodiment, sensor measurements can be communicated directly to the external control unit 1004b, where the energy balance and / or current energy requirements can be determined at the external control unit 1004b, and The above-described functions of the internal control unit 1015 are integrated into the external control unit 1004b. In this case, the internal control unit 1015 can be eliminated and the measurement by the sensor is fed directly to the internal signal transmitter 1027 that transmits this measurement to the external signal receiver 1004c and the external control unit 1004b. The energy balance and the current energy requirement can then be determined by the external control unit 1004b based on measurements by these sensors.

  For this reason, the present solution according to the configuration of FIG. 38 utilizes feedback of information indicating the required energy, which may be due, for example, to an energy component, energy difference, or implanted component that consumes device energy. It is more efficient than previous solutions because it is based on the actual use of energy compared to the received energy with respect to the energy reception rate compared to the energy usage rate. The device may be used to consume received energy or store it in an implanted energy source or the like. Thus, the various parameters discussed above are used as a tool to determine the actual energy balance when it is appropriate and necessary. However, such parameters may also be required by themselves for any action that occurs internally for a specific operation of the device.

  The internal signal transmitter 1027 and the external signal receiver 1004c may be implemented as separate units using appropriate signal conversion means such as radio signals, IR (infrared) signals or ultrasonic signals. Alternatively, the internal signal transmitter 1027 and the external signal receiver 1004c may be respectively implanted with an implanted energy conversion device 1002 and a carrier to carry the control signal in the opposite direction of energy transfer using essentially the same transfer technique. It may be integrated into the external energy source 1004a. The control signal may be modulated with respect to frequency, phase or amplitude.

  Thus, the feedback information may be converted in a separate communication system that includes the receiver and transmitter, and the receiver and transmitter may be integrated into the energy system. According to the present invention, such an integrated information feedback and energy system includes an implantable internal energy receiver for receiving wireless energy, a first internal coil, and a first electronic connected to the first coil. An energy receiver having a circuit, and an external energy transmitter for transmitting wireless energy, a second external coil and an energy transmitter having a second electronic circuit connected to the second coil. The second external coil of the energy transmitter transmits radio energy received by the first coil of the energy receiver. The system further comprises a power switch for switching on and off the connection between the first internal coil and the first electronic circuit, the feedback information relating to the charging of the first coil is provided by the power switch. Received by the external energy transmitter in the form of an impedance variation of the load of the second external coil when switching the connection of the first electronic circuit to and from the first electronic circuit. In implementing this system having the configuration shown in FIG. 38, the switch 1026 is controlled by the internal control unit 1015 as a separate unit or integrated into the internal control unit 1015. It should be understood that the switch 1026 is to be interpreted in its broadest embodiment. This means a transistor, MCU, MCPU, ASIC, FPGA or DA converter or any other electronic component or circuit that can be turned on and off.

  In conclusion, the energy supply configuration shown in FIG. 38 may operate in the following manner basically. First, the energy balance is determined by the internal control unit 1015 of the determination device. The internal control unit 1015 also generates a control signal reflecting the required amount of energy, and transmits the control signal from the internal signal transmitter 1027 to the external signal receiver 1004c. Alternatively, the energy balance can be determined by the external control unit 1004b, depending on the implementation described above. In this case, the control signal may carry measurement results from various sensors. The amount of energy emitted by the external energy source 1004a can then be adjusted by the external control unit 1004b based on the determined energy balance, ie, in response to the received control signal. This process may be repeated intermittently at specific intervals while energy conversion is taking place, or may be performed on a somewhat continuous basis during energy conversion.

  In general, the amount of energy transferred can be adjusted by adjusting various transfer parameters of the external energy source 1004a, such as voltage, current, amplitude, frequency and pulse characteristics.

  The system also finds the optimal position of the external coil relative to the internal coil and obtains information about the coupling coefficient between the coils of the TET system to calibrate the system to optimize energy conversion. May be used. In this case, the amount of energy converted is simply compared with the amount of energy received. For example, as the external coil moves, the coupling coefficient can change, and an accurately displayed action can find the optimal position of the external coil for energy conversion. Preferably, the external coil is adapted to calibrate the amount of energy to be converted to obtain feedback information at the decision device before the coupling coefficient is maximized.

  This coupling coefficient information may also be used as feedback during energy conversion. In such a case, the energy system of the present invention includes an energy having an implantable internal energy receiver for receiving wireless energy, a first internal coil, and a first electronic circuit connected to the first coil. An energy transmitter having a receiver and an external energy transmitter for transmitting wireless energy, a second external coil and a second electronic circuit connected to the second coil. The second external coil of the energy transmitter transmits radio energy received by the first coil of the energy receiver. The system further comprises a feedback device for communicating the amount of energy received by the first coil to the outside as feedback information, wherein the second electronic circuit is for receiving the feedback information and for the second A determination device is included for comparing the amount of energy converted by the two coils with the amount of energy received by the first coil to obtain a coupling coefficient between the first coil and the second coil. The energy transmitter can adjust the energy transmitted according to the obtained coupling coefficient.

  Referring to FIG. 39, it has been described above that wireless conversion of energy to operate the device to allow non-invasive operation, but the device can also be operated with wireline energy. Such an embodiment is shown in FIG. 39, where the external switch 1026 is interconnected between an external energy source 1004a and an operating device such as an electronic motor 1007 that operates the apparatus 10. The external control unit 1004b controls the operation of the external switch 1026 to bring about proper operation of the device 10.

  FIG. 40 shows various embodiments regarding how received energy is supplied to and used by the device 10. As in the embodiment of FIG. 38, the internal energy receiver 1002 receives wireless energy E from an external energy source 1004a controlled by the transmission control unit 1004b. The internal energy receiver 1002 may comprise a constant voltage circuit, represented in the figure as a dashed box “voltage V”, for supplying energy to the device 10 at a constant voltage. The internal energy receiver 1002 may further comprise a constant current circuit, represented in the figure as a dashed box “current C”, for supplying energy to the device 10 at a constant current.

  The apparatus 10 comprises an energy consuming component, which may be a motor, pump, restriction device, or any other medical instrument that requires energy for electronic 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 may be consumed directly by an energy consuming component, or may be stored by an energy storage device, or the supplied energy may be partially consumed and partially stored. Good. The apparatus 10 may further comprise an energy stabilization unit for stabilizing the energy supplied from the internal energy receiver 1002. Thus, the energy may be supplied in a fluctuating state so that it may need to be stabilized before being consumed or stored.

  The energy supplied from the internal energy receiver 1002 may be further accumulated and / or stabilized in a separate energy stabilization unit 1028 located outside the device 10 before being consumed and / or stored in the device 10. Alternatively, the energy stabilization unit 1028 may be integrated into the internal energy receiver 1002. In any case, the energy stabilization unit 1028 may comprise a constant voltage circuit and / or a constant current circuit.

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

  FIG. 41 schematically shows an energy balance measurement circuit of one of the proposed designs of a system for controlling the transmission of wireless energy or an energy balance control system. The circuit is centered at 2.5V and has an output signal proportionally related to the energy imbalance. The derivative of this signal indicates whether this value rises or falls and how quickly such a change occurs. If the amount of energy received is less than the energy used by the implanted components of the device, more energy is converted and the energy source is charged. The output signal from the circuit is typically supplied to an A / D converter and converted to a digital format. This digital information is then transmitted to an external energy transfer device so that the level of energy transferred can be adjusted. Another possibility is to have a completely analog system that uses a comparator that compares the energy balance level with specific maximum and minimum thresholds, where the balance varies outside the maximum / minimum window. Send information to an external energy transfer device.

  FIG. 41 shows an implementation of a circuit for a system that converts energy from outside the patient's body to the energy consuming implanted component of the device of the present invention using inductive energy conversion. Inductive energy conversion systems typically use an external transfer coil and an internal receive coil. The internal receiving coil L1 is included in the schematic diagram 24 and does not include the transmission components of the system.

  Implementation of the general concept of energy balance and implementation of the method of communicating information to an external energy transmitter can of course be done in a number of different ways. The schematic 41 and the above-described method of evaluating and communicating information should be understood as merely examples of how to implement a control system.

Circuit Details In FIG. 41, test points in a circuit are represented by symbols Y1, Y2, Y3, and the like. The components in the figure and their respective values are the values that will work in this particular implementation, and this implementation is, of course, just one of infinitely possible design methods.

  The energy that powers the circuit is received by the energy receiving coil L1. The energy to the implanted component is transmitted at a frequency of 25 kHz in this particular example. The energy balance output signal is present at test point Y1.

  One skilled in the art will appreciate that the various embodiments described above of the system can be combined in many different ways. For example, the electronic switch 1006 of FIG. 24 can be incorporated into any of the embodiments of FIGS. 27-33, the hydraulic valve shift device 1014 of FIG. 27 can be incorporated into the embodiment of FIG. Can be incorporated into the embodiment of FIG. “Switch” can simply mean any electronic circuit or component.

  The embodiments described in connection with FIGS. 38, 40 and 41 identify a method and system for controlling the transmission of wireless energy to an implanted component that consumes the energy of an electronically operable device. Such methods and systems are defined below in a general sense.

  Thus, as described above, a method is provided for controlling the transmission of wireless energy supplied to an implanted component that consumes the energy of the device. Wireless energy E is transmitted from an external energy source located outside the patient's body, which is received by an internal energy receiver located within the patient's body, which consumes the received energy from the device's energy. Connected to the implanted component for direct or indirect supply. An energy balance is determined between the energy received by the internal energy receiver and the energy used by the device. And transmission of the wireless energy E from an external energy source is controlled based on the determined energy balance.

  Wireless energy may be inductively transferred from a primary coil of an external energy source to a secondary coil of the internal energy receiver. Changes in the energy balance may be detected, and wireless energy transmission may be controlled based on the detected energy balance. A difference between the energy received by the internal energy receiver and the energy used by the medical device may be detected, and the transmission of wireless energy may be controlled based on the detected energy difference.

  In controlling energy transfer, if the detected change in energy balance implies that the energy balance is increasing, the amount of wireless energy transmitted may be reduced, and conversely, the energy balance is increasing. If implied, the amount of wireless energy transmitted may be increased. The reduction / increase in energy transfer may further correspond to the detected rate of change.

  If the detected energy difference implies that the received energy is greater than the used energy, the amount of radio energy transmitted may be further reduced, and conversely, the received energy is less than the used energy. If implied, the amount of wireless energy transmitted may be further increased. And the decrease / increase in energy transfer may further correspond to the magnitude of the detected energy difference.

  As described above, energy used in the medical device may be consumed to operate the medical device and / or stored in at least one energy storage device of the medical device.

  When determining electrical and / or physical parameters of a medical device and / or physical parameters of a patient, energy is transmitted for consumption or storage according to a transmission rate per unit time determined based on the parameters. Good. The total amount of energy transmitted may also be determined based on the above parameters.

  If 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 at least one measured for the energy balance When related to the integration of electrical parameters with respect to time, this integration may be determined for the monitored voltage and / or current with respect to the energy balance.

  If the derivative is determined in terms of time for a measured electrical parameter with respect to the amount of energy consumed and / or stored, this derivative may be determined for the monitored voltage and / or current with respect to the energy balance. .

  The transmission of wireless energy from an external energy source may be controlled by applying an electrical pulse from the first electronic circuit to the external energy source to transmit the wireless energy, the electrical pulse being transmitted at the leading and trailing edges. And / or a first time length between successive leading and trailing edges of the electrical pulse and / or a second length of time between successive trailing and leading edges of the electrical pulse. Fluctuating and transmitting wireless energy, which is generated from electrical pulses having varying power, the power variation depending on the length of the first and / or second time.

  In this case, the frequency of the electrical pulse may be substantially constant as the length of the first and / or second time varies. When applying the electrical pulse, the electrical pulse may remain unchanged except that the length of the first and / or second time varies. The amplitude of the electrical pulse may be substantially constant as the length of the first and / or second time varies. Furthermore, the electrical pulse may only vary due to a variation in the length of the first time between successive leading and trailing edges of the electrical pulse.

  A sequence of two or more electrical pulses may be supplied in a row, where when applying a sequence of pulses, the sequence is the first electrical pulse that is the head of the sequence of pulses, and the pulse Having a second electrical pulse that is the end of the sequence, and providing two or more sequences of pulses in a row, wherein the trailing edge of the second electrical pulse in the first sequence of pulses; The length of the second time between successive leading edges of the first electrical pulse in the second series of pulses varies.

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

  The circuit formed by the first electronic circuit and the external energy source may have a first characteristic time period or a first time constant, and this frequency time period when effectively changing the transmitted energy. Is within or shorter than the first characteristic time period or the first time constant.

  Thus, a system comprising a device as described above is also provided for controlling the transmission of wireless energy supplied to an implanted component that consumes the energy of the device. In its broadest sense, the system comprises a control device for controlling the transmission of wireless energy from the energy conversion device, and an implantable internal energy receiver for receiving the transmitted wireless energy. The energy receiver is connected to it to directly or indirectly supply the received energy to an implantable component that consumes the energy of the device. 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 implantable component that consumes the energy of the device, wherein Thus, the control device controls the transmission of wireless energy from the external energy transfer device based on the energy balance determined by the determination device.

  In one embodiment, at least one battery may be part of the energy conversion device 1002 or may replace the energy conversion device 1002 to supply energy to the apparatus 10 via the power supply line. . In one embodiment, the battery is not rechargeable. In an alternative embodiment, the battery is rechargeable. Of course, the battery supply may be remote from the device and incorporated into the device.

  In addition, the system may include any of the following features.

  An external energy source main coil adapted to inductively transmit wireless energy to the internal energy receiver secondary coil;

  The decision device is adapted to detect changes in the energy balance, and the control device controls the transmission of wireless energy based on the detected changes in energy balance;

  The decision device is adapted to sense the difference between the energy received by the internal energy receiver and the energy used for the implantable component that consumes the energy of the device; The transmission of wireless energy is controlled based on the difference in energy.

  The control device controls the external energy transfer device to reduce the amount of wireless energy transferred if the sensed change in energy balance implies that the energy balance is increasing, conversely When implying that the balance is increasing, the amount of radio energy transferred is increased, where the decrease / increase in energy transfer corresponds to the rate of change detected.

  -The control device controls the external energy transfer device to further reduce the amount of transmitted radio energy if the detected energy difference implies that the received energy is greater than the energy used, and vice versa If the received energy is less than the used energy, the amount of transmitted radio energy is further increased, where the decrease / increase in energy transfer corresponds to the magnitude of the detected energy difference. To do.

  The energy used in the apparatus is consumed to operate the apparatus and / or stored in at least one energy storage device of the apparatus.

  When determining the electrical and / or physical parameters of the device and / or the physical parameters of the patient, the energy transfer device determines the energy according to the transmission rate per unit time determined by the vise in the determination based on the parameters Communicate for consumption or storage. The determining device also determines the total amount of energy transmitted based on the parameters.

  -If 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 at least one measured for the energy balance; The determination device determines this integral for the monitored voltage and / or current with respect to the energy balance.

  If the derivative is determined in terms of time for a measured electrical parameter with respect to the amount of energy consumed and / or stored, the determining device determines this derivative with respect to the voltage and / or current monitored with respect to the energy balance Decide on.

  The energy transfer device comprises a coil arranged outside the human body and provides an electronic circuit for powering the external coil by means of electrical pulses to transmit wireless energy; The electrical pulse has a leading edge and a trailing edge, and the electronic circuit has a first length of time between successive leading and trailing edges of the electrical pulse and / or a continuous trailing and leading edge of the electrical pulse. It is adapted to vary the length of the second time between the edges to vary the power of the transmitted radio energy. As a result, the energy receiver that receives the transmitted wireless energy has varying power.

  The electronic circuit is adapted to deliver the electrical pulse such that the electrical pulse remains unchanged except that the length of the first and / or second time varies.

  The electronic circuit has a time constant and is adapted to vary the first and second times only within the range of the first time constant, whereby the length of the first and / or second time is When it fluctuates, the power transmitted across the coil fluctuates.

  The electronic circuit is adapted to deliver an electrical pulse such that the electrical pulse varies only by a first time length variation between successive leading and trailing edges of the electrical pulse;

  The electronic circuit is adapted to supply a sequence of two or more electrical pulses in a row, the sequence being the first electrical pulse that is the beginning of the sequence of pulses and the end of the sequence of pulses Having a second electrical pulse.

  Between the trailing edge of the second electrical pulse in the first series of pulses by the first electronic circuit and the leading edge of the first electrical pulse in the second series of pulses in succession with the first electronic circuit; The length of the second time is varied.

  The electronic circuit is adapted to supply an electrical pulse, such as a pulse having a substantially constant height and / or amplitude and / or strength and / or voltage and / or current and / or frequency.

  The electronic circuit has a time constant and is adapted to vary the first and second times only within the range of the first time constant, whereby the length of the first and / or second time is When fluctuating, the power transmitted across the first coil fluctuates.

  The electronic circuit compares the length of the first and / or second time within a range including the first time constant or the magnitude of the first time constant, and compares the first time constant It is adapted to supply electrical pulses that vary only within a range located in the vicinity of the target.

  FIGS. 42-45 show in more detail block diagrams of four different methods of powering an implanted device according to the present invention using hydraulic or pneumatic pressure.

  FIG. 42 shows a system as described above. The system includes an implanted device 10 and further includes a separate regulating reservoir 1013, a one-way pump 1009 and a replacement valve 1014.

  FIG. 43 shows the device 10 and fluid reservoir 1013. By moving the reservoir wall by any other different method, or by changing the size of the regulator reservoir, no valve is required, just moving the fluid freely at any time by moving the reservoir wall Thus, the apparatus can be adjusted.

  FIG. 44 shows the device 10, bi-directional pump 1009 and regulating reservoir 1013.

  FIG. 45 shows a block diagram of a reverse servo system having a first closed system that controls a second closed system. The servo system includes an adjustment reservoir 1013 and a servo reservoir 1050. Servo reservoir 1050 mechanically controls implanted device 10 via mechanical interconnect 1054. The device 10 has an inflatable / contactable cavity. Preferably, the cavity expands or contracts by supplying hydraulic fluid from a larger adjustable reservoir 1052 that is in fluid communication with the device. Alternatively, the cavity can contain a compressible gas that can be compressed and expanded under the control of the servo reservoir 1050.

  Servo reservoir 1050 can also be part of the device itself.

  In one embodiment, the conditioning reservoir is placed under the patient's skin and is operated by pushing the outer surface with a finger. Figures 46a-c illustrate this system. In FIG. 46a, a flexible subcutaneous adjustment reservoir 1013 is shown, which is connected to an inflated servo reservoir 1050 using a conduit 1011. FIG. This bellow-shaped servo reservoir 1050 is included in the flexible device 10. In the state shown in FIG. 46 a, it can be seen that the servo reservoir 1050 contains a small amount of fluid and most of the fluid is in the conditioning reservoir 1013. Due to the mechanical interconnection between the servo reservoir 1050 and the device 10, the outer shape of the device 10 contracts, ie occupies a volume less than its re-large volume. This maximum volume is indicated by a broken line in the figure.

  FIG. 46b shows that a user, such as a patient implanted with the device, pushes the adjustment reservoir 1013 to allow fluid contained therein to flow through the conduit to the servo reservoir 1015, which causes the servo reservoir 1015 to move longitudinally due to its bellows shape. Shows the expanded state. This expansion in turn expands the device 10, which occupies its maximum volume, thereby pulling the stomach wall (not shown) with which it is in contact.

  Preferably, the adjustment reservoir 1013 is provided with means 1013a for maintaining its shape after compression. Thus, this means, shown schematically in the figure, keeps the device 10 in the traction position when the user releases the adjustment reservoir. In this way, the regulation reservoir essentially acts as an on / off switch for the system.

  Alternative embodiments of hydraulic or pneumatic operation are described herein with reference to FIGS. 47 and 48a-c. The block diagram shown in FIG. 47 includes a first closed system that controls the second closed system. The first closed system includes an adjustment reservoir 1013 and a servo reservoir 1050. Servo reservoir 1050 mechanically controls a larger adjustable reservoir 1052 via mechanical interconnect 1054. The implanted device 10 having an inflatable / contactable cavity is then controlled by a larger adjustable reservoir 1052 by supplying hydraulic fluid from a larger adjustable reservoir 1052 fluidly connected to the device 10. The

  An example of this embodiment will now be described with reference to FIGS. 48a-c. As in the previous embodiment, the adjustment reservoir is placed under the skin of the patient and is operated by pushing the outer surface with a finger. The conditioning reservoir 1013 is fluidly connected to a bellows shaped servo reservoir 1050 using a conduit 1011. In the first closed system 1013, 1011, 1050 shown in FIG. 48a, it can be seen that the servo reservoir 1050 contains a small amount of fluid and most of the fluid is in the regulation reservoir 1013.

  The servo reservoir 1050 is mechanically connected to a larger adjustable reservoir 1052, and in this example, the larger adjustable reservoir 1052 also has a bellows shape, but has a larger diameter than the servo reservoir 1050. A larger adjustable reservoir 1052 is fluidly connected to the device 10. This is because when the user presses the adjustment reservoir 1013, fluid moves from the adjustment reservoir 1013 to the servo reservoir 1050, and expansion of the servo reservoir 1050 causes a larger volume of fluid from the larger adjustable reservoir 1052. , Means moving to the device 10. In other words, with this reverse servo, the small volume of the adjustment reservoir is compressed with a stronger force, which produces a larger total area movement with a smaller force per unit area.

  Similar to the previous embodiment described above with reference to FIGS. 46a-c, the conditioning reservoir 1013 is preferably provided with means 1013a for maintaining its shape after compression. Thus, this means, shown schematically in the figure, keeps the device 10 in the traction position when the user releases the adjustment reservoir. In this way, the regulation reservoir essentially acts as an on / off switch for the system.

  The case where one identical volume filling device is invaginated in the stomach wall has already been described. Alternatively, two or more volume filling devices 10 may be indented to obtain the desired reduction in food cavities. One such example is shown in FIG. 49, where three ball-shaped volume filling devices 10 are invaginated in the stomach wall of the patient's stomach 12.

  A method for invading the volume filling device 10 into the stomach wall using an endoscopic instrument has already been described. It will be understood that the method by open surgery can be used as well. Such a method will now be described in detail with reference to FIGS. 50a and 50b.

  FIG. 50 shows an embodiment of an apparatus according to the present invention. FIG. 50 shows a segment of a volume filling device that is assembled prior to implantation into a patient in need of obesity treatment. The volume filling device segment includes a core part 560 and four external parts 561a-561d. A generally cylindrical core component includes an upper portion 560 'and four slits 562a-562d that are symmetrically distributed and extended along the outer peripheral surface of the core component. External components 561a-561d are generally shown as part of a sphere having an inner surface and an outer surface, and each component includes a protruding flange 563a-563d that extends along the inner surface. In the illustrated embodiment, the flanges 563a-563d engage the slits 562a-562d, but can also be designed to fit loosely between the flanges and slits, thus the assembled volume filling device is It is fully assembled at the transplant target location at the top of the cardia. If the volume filling device inadvertently leaves this position and moves to the gastric cavity, the loosely fitting configuration contributes to rapid disassembly of the segments. The core part connects to a guide wire 564 that extends through the first channel 565 of the core part and through a corresponding channel 565a between the two adjacent orifices of the protrusion 563a of the first outer part 561a. Is done. When the guide wire 564 is manipulated by moving it away from the top surface 560 'of the core part, the first external part 561a moves toward the core part, the flange 563a meets the slit 562a, and the first External parts are assembled to the core part 560. As illustrated in FIG. 51, this operation is now performed by a second external component by means of a guide wire 564 that passes through a second channel 566 connected to a corresponding channel of the flange 563b of the second external component 561b. Repeat about. FIG. 52 again illustrates this operation with respect to the assembly of the third external component 561c and the third channel 567 connecting the guidewire 564 to the flange 563c. FIG. 53 shows the fourth and final outer part 561d assembled via flange 563d and channel 568. FIG. FIG. 55a is a more detailed view of the core part showing a system of channels for the guide wire. Figures 55b-55e are cross-sectional views in planes II, II-II, III-III, IV-IV, and VV, each at a height for four channels.

  The guidewire is made of a biodegradable material that is broken down if the volume filling device has accidentally moved from the implantation position, and the segments are easily separated. The segments shown here are made of a biocompatible solid material and are each sized and shaped to allow easy passage through the gastrointestinal system when the volume filling device is disassembled. Any of the methods previously described are suitable for implanting a volume filling device assembled in this manner.

  FIG. 56 is an illustration of an embodiment of assembling a volume filling device. The outer shape of the core part and the segment is the same as that shown in FIG. 50 except that the flange 563a-d of the segment is engaged with the protrusion 562′a-d of the slit 562a-d of the core part. a-d are provided and the assembled device is locked along two different planes. In this embodiment, these planes are arranged vertically. FIG. 57 shows another embodiment of the volume filling device according to FIG. 56 without a guide wire and without any features for the guide wire in the segment. In this embodiment, the engagement and locking elements need to be adapted to assist disassembly if the volume filling device has been inadvertently moved from the implantation position.

  A method of injecting or inserting a plurality of volume filling device segments into a sac formed by a portion of the stomach wall will now be described with reference to FIGS. 58a-d. In this example, the volume filling device described above with reference to FIG. 50 is used. A tube-like device, generally represented by 600 and illustrated by way of example in FIG. 4b, comprises a sleeve 600a, which has a cross-sectional diameter through which a core part 560 and four external parts 561a-561d can pass. And having a shape. A piston 602 is provided to move the volume filling device segment through the sleeve 600a to the space where the volume filling device segment is assembled to form the volume filling device. In this example, the device 600 is used to insert or inject a volume filling device segment through the hole 12a in the patient's stomach wall portion 12, as shown in FIG. 58a.

  As shown in FIG. 58b, the guide wire 564 places the outer parts 561a-d in a petal-like arrangement and assembles the outer parts 561a-d and the core part 560 into an essentially spherical volume filling device 10. So that the core part 560 can take such a position. By pulling on the guide wire 564, the external parts 561a-d move and engage the core part 560, as shown in FIG. 58c, and maintain a predetermined position using the connecting flanges 563a-d.

  After complete assembly as shown in FIG. 58d, the essentially spherical volume filling device 10 is invaginated into a portion of the stomach wall 12 using sutures or stapling 14. The limited space of the sac formed by the stomach wall prevents the volume filling device 10 from falling apart even after the biodegradable guidewire 564 is disassembled. However, if the volume filling device 10 loosens, such as by stitching or stapling 14 coming off, the volume filling device 10 will break apart, allowing different segments, each smaller than the volume filling device 10, to pass through the digestive tract system.

  It will be apparent from the overall description and the appended claims that many other ways of designing a volume filling device are possible without departing from the inventive concept. One such method is to form a volume filling device with a plurality of relatively small volume filling device segments, which are described herein with reference to FIGS. 59a-c.

  This method of injecting or inserting the volume filling device segment into the sac is similar to that described above with reference to FIGS. 4a-d after the sac is created in the stomach wall. Accordingly, FIG. 59a shows the stomach wall portion 12a after suturing or stapling 14 to create a sac in the stomach wall. The sac can be provided using the method described above with reference to FIGS. 5a-i.

  The volume filling device 10 is inserted or infused into the sac using an endoscopic or laparoscopic tube-like device 600 as shown in FIG. 4b. As shown in FIG. 4b, the device comprises an outer sleeve and an inner sleeve that can be displaced longitudinally relative to the outer sleeve. The inner sleeve is provided with a cutter in the form of a cutting blade 615 at its distal end. Using this cutting blade, the stomach wall can be cut and perforated as described in detail below.

  Upon reaching the device outer wall, the inner sleeve advances from its position in the outer sleeve and contacts the stomach wall 12a. An internal sleeve cutting blade 615 can then cut the stomach wall to open a hole, and then the volume filling device 10 can be inserted into and through the hole as shown in FIG. 59b. . A piston 602 may be provided in the instrument to push the volume filling device through this hole. Thus, the apparatus further comprises a piston 602 adapted to push a plurality of volume filling devices 10 from a position in the inner sleeve shown in FIG. 59a to a position outside the inner sleeve shown in FIG. 59b.

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

  In the illustrated embodiment, the tube-like device 600 is provided with a cup-shaped extension that maintains the sac in place while the volume filling device segment 10 is inserted into the sac. During this process, by gradually pulling out the tube-like device 600, the sac can be filled with the volume filling device segment 10 in a controlled manner, as shown in FIG.

  After filling the sac with the volume filling device segment to the desired degree, as shown in FIG. 59c, the tube 12 is cut through the stomach wall 12a using the tube-like device 600 to open the hole 12b, for example, by suturing or stapling. Use and permanently close.

  In the embodiment shown in FIGS. 59a-c, the tube-like device 600 comprises a piston 602 adapted to push and displace the volume filling device segment 10 along the sleeve 600b. Alternatively, as shown in FIG. 59, fluid pressure can be used to push or displace the volume filling device segment 10.

  The volume filling device segment 10 can take many different shapes. In the embodiment shown in FIGS. 58a-c and 59, the volume filling device segment is essentially spherical. However, in alternative embodiments, they exhibit one or more flat or essentially flat surfaces. And preferably, they take the shape of a polyhedron, such as a tetrahedron, hexahedron, octahedron, dodecahedron, icosahedron, ie, a polyhedron having flat surfaces of 4, 6, 8, 12, and 20, respectively. . These examples of volume filling device segments are shown in FIGS. 61a-e.

  Further, the volume filling device can maintain its interrelationship using additional means. For example, the surface of the volume filling device segment can be provided with a friction enhancer or friction enhancing material to minimize slippage of the volume filling device segment. The friction enhancer can be any type of adhesive or the like. Alternatively or additionally, one or more surfaces of the volume filling device segment can be imparted with an uneven texture to increase friction between adjacent volume filling device segments.

  As described above, the volume filling device 10 can be inflated by a gel or fluid supplied to a chamber defined by the volume filling device 10, as shown in FIG.

  Inserting or injecting multiple volume filling device segments 10 into a natural sac provided in the stomach wall portion 12 has been described above with reference to FIGS. 59a-d. However, in an alternative embodiment of an apparatus for treating obesity, the volume filling device segment may also comprise a volume filling device segment for bringing together two or more volume filling device segments of different types. Accordingly, the apparatus comprises an inflatable second volume filling device segment 10 ′ for bringing together two or more first volume filling device segments different from the second volume filling device segment, wherein The second volume filling device segment and the first volume filling device segment together form a volume filling device. The second volume filling device segment is preferably flexible or stretchable.

  In an alternative embodiment, a friction reducing fluid may be present to reduce friction between adjacent volume filling device segments to allow reshaping of the volume filling device. FIG. 64 shows a method of providing a plurality of volume filling device segments 10 in a sac formed in a portion of the stomach wall 12, and fluid is injected into the sac, thereby causing the adjacent first The volume filling device segments can interact with each other so that when the volume filling device described above is invaginated into the stomach wall, the shape of the volume filling device conforms to the movement of the stomach wall.

  Combining the embodiments of FIGS. 63 and 64, different volume filling device segments 10, in this case spherical, by the outer volume filling device 10 ′ and fluids that reduce friction between the different volume filling device segments May be sealed.

  The fluids described above can increase the friction between adjacent volume filling device segments to make the volume filling device device more stable, instead of reducing the friction between adjacent volume filling device segments. The friction enhancing material may be an adhesive or a pressure sensitive adhesive, i.e. a solidifying liquid.

  Volume filling device segments adapted for multiple use to form a volume filling device have been described above with reference to FIGS. 59a-c and 59a-e. It will be appreciated that these volume filling device segments can have similar properties with respect to materials, properties, etc. as previously described volume filling devices.

  In a first alternative embodiment, the volume filling device is implanted using a laparoscopic method instead of the intraluminal method described above. According to this embodiment, a needle or tube-like device is inserted into the abdomen of the patient's body, and then the patient's abdomen is filled with gas using the needle or tube-like device. Subsequently, at least two laparoscopic trocars are inserted into the patient's body and a camera is inserted through one of the at least two laparoscopic trocars. At least one dissecting instrument is then inserted through one of the at least two laparoscopic trocars to dissect the region of the stomach. A volume filling device is then introduced into the abdominal cavity and placed outside the stomach wall. A sac for the device is created in the stomach wall and the stomach wall is sutured or stapled to cause the device to intrude into the sac, thereby allowing the size of the volume of the food cavity to be Position the volume filling device so that it is reduced by a volume that substantially exceeds the volume of the device.

  Preferably, the first alternative embodiment described above further comprises attaching the device to the stomach wall by suturing or stapling.

  Preferably, the alternative embodiment described above further comprises providing an apparatus for adjusting the obesity treatment device from outside the patient's body; and operating the apparatus to adjust the obesity treatment device. Further, adjusting the obesity treatment device includes changing the volume of the filling body of the volume filling device during implantation.

  Preferably, the above-described embodiments further comprise providing an injection type syringe containing fluid for injection into the implanted filling body; and injecting a volume of fluid into the filling body.

  According to certain embodiments, the device is sealed within the sac, or the sac is left at least partially open and partially sealed. Furthermore, the sac can be designed to have only one opening. Alternatively, the sac is designed to have two openings and extend so as not to surround the stomach.

  Preferably, the sac has a volume greater than 15 milliliters.

  In the second alternative embodiment, the laparoscopic method is again used instead of the intraluminal method, and the initial steps are similar to those described in the first alternative embodiment, but with subsequent gastric anatomy, A hole is created and a volume filling device is introduced into the abdominal cavity and through the hole into the stomach. The device is placed inside the stomach wall and a sac is created outside the stomach cavity for the device placed inside the stomach wall, and the device is sunk into the sac by suturing and stapling the stomach wall. And thereby positioning the volume filling device such that the size of the volume of the food cavity is reduced by a volume that substantially exceeds the volume of the volume filling device.

  Preferably, the above-described embodiments further comprise attaching the device to the stomach wall by applying sutures or stapling. According to one embodiment, the stomach wall is attached to the lower part of the patient's esophagus by suturing or stapling.

  Preferably, the second alternative embodiment described above further comprises providing an apparatus for adjusting the obesity treatment device from outside the patient's body; and operating the apparatus to adjust the obesity treatment device. Further, adjusting the obesity treatment device includes changing the volume of the filling body of the volume filling device during implantation.

  Preferably, the above-described embodiments further comprise providing an injection type syringe containing fluid for injection into the implanted filling body; and injecting a volume of fluid into the filling body.

  According to certain embodiments, the device is sealed within the sac, or the sac is left at least partially open and partially sealed. Furthermore, the sac can be designed to have only one opening. Alternatively, the sac is designed to have two openings and extend so as not to surround the stomach.

  Preferably, the sac has a volume greater than 15 milliliters.

  A third alternative embodiment involves a surgical incision instead of intraluminal or laparoscopic methods. Here, an opening in the patient's abdominal wall is created by a surgical incision to dissect the patient's stomach area. Volume filling device is introduced through the abdominal incision and attached to the stomach wall, thereby reducing the size of the volume of the food cavity by a volume substantially exceeding the volume of the volume filling device Position the device.

  In an alternative embodiment of the third alternative embodiment described above, the initial steps are similar, including the dissection of the stomach region. Following this, a sac of the stomach wall for the device is created and the device is invaginated into the sac by suturing and stapling the stomach wall, thereby reducing the size of the volume of the food cavity. Position the volume filling device so that it is reduced by a volume that substantially exceeds the volume of the volume filling device.

  In yet another alternative embodiment of the third alternative embodiment described above, the initial steps are similar, including dissection of the stomach region. Following this, a hole is created in the stomach wall and a volume filling device is introduced into the stomach through the hole. The device is then placed inside the stomach wall to produce a stomach wall sac for the device. The device is then invaginated by suturing and stapling the stomach wall so that the size of the volume of the food cavity is reduced by a volume that substantially exceeds the volume of the volume filling device. Position the volume filling device.

  Preferably, the third alternative embodiment described above further comprises attaching the device to the stomach wall by applying sutures or stapling.

  Preferably, the alternative embodiment described above further comprises providing an apparatus for adjusting the obesity treatment device from outside the patient's body; and operating the apparatus to adjust the obesity treatment device. Further, adjusting the obesity treatment device includes changing the volume of the filling body of the volume filling device during implantation.

  Preferably, the above-described embodiments further comprise providing an injection type syringe containing fluid for injection into the implanted filling body; and injecting a volume of fluid into the filling body.

  According to certain embodiments, the device is sealed within the sac, or the sac is left at least partially open and partially sealed. Furthermore, the sac can be designed to have only one opening. Alternatively, the sac is designed to have two openings and extend so as not to surround the stomach.

  Preferably, the sac has a volume greater than 15 milliliters.

  A fourth alternative embodiment includes inserting a needle or tube-like device into the abdomen of the patient's body; filling the patient's abdomen with gas using the needle or tube-like device; at least two abdominal cavity Inserting a mirror trocar into the patient's body; inserting a camera into the patient's abdomen through one of the at least two laparoscopic trocars; inserting at least one dissecting instrument through one of the at least two laparoscopic trocars Dissecting the region of the stomach; creating a sac for the device in the stomach wall; closing the sac by applying sutures or stapling; injection comprising an injectable filling material Introducing a member; and filling the sac with filling material to fill the stomach volume of the patient Form, comprising the step of reducing the size of the food for cavity, the volume of the volume filling device only volume substantially greater than.

  As an alternative to the laparoscopic method described above, a surgical incision or opening is made in the skin to enter the patient's abdomen; a region of the stomach is dissected; a sac for the device is created in the stomach wall; suturing and stapling To close the sac-like portion. Next, an injection member containing an injectable filling material is introduced; filling material is injected into the sac to reduce the size of the food cavity by a volume substantially exceeding the volume of the volume filling device Generate the body.

  According to an alternative embodiment of the alternative embodiment described above, the sac is created outside the stomach wall and the filling body is placed against the inside of the stomach wall.

  The method according to the above two embodiments includes creating a hole in the stomach wall, wherein the sac is created inside the stomach wall and the filling body is placed against the outside of the stomach wall.

  The method according to the above two embodiments further comprises attaching the stomach wall to the lower part of the patient's esophagus by applying sutures or stapling, or attaching the stomach wall to the patient's diaphragm muscle or other muscle tissue. May include.

  Preferably, the sac has a volume greater than 15 milliliters.

  In the method according to the above two embodiments, preferably the filling material can undergo a curing process from a liquid state to a semi-solid or solid state. Preferably, the curing process is initiated by a temperature increase from ambient temperature to body temperature.

  The present invention also allows a method of treating patient obesity by implanting a volume filling device that, when implanted in a patient, substantially reduces the size of the food cavity and the volume of the volume filling device. The method includes inserting a needle or tube-like device into the abdomen of the patient's body; filling the patient's abdomen with gas using the needle or tube-like device; Inserting two laparoscopic trocars into a patient's body; inserting a camera into the patient's abdomen through one of the at least two laparoscopic trocars; and inserting at least one dissecting instrument into the at least two laparoscopic trocars Inserting through one; dissecting the region of the stomach; creating a hole in the stomach wall; Introducing the device into the stomach through the hole; placing the device outside the stomach wall; securing the device located outside the stomach wall, thereby filling the size of the food cavity Generating a filling body that reduces the volume of the device substantially beyond the volume.

  In the method described above, the device is preferably attached to the stomach wall by suturing or stapling.

  The present invention also includes a laparoscopic instrument for providing a volume filling device that is invaginated into the stomach wall of a human patient to treat obesity, the instrument being used for any of the laparoscopic methods described above. The device comprises an elongated member having a proximal end and a distal end, the elongated member having a smaller diameter than a laparoscopic trocar introduced into a patient's abdomen during laparoscopic operation; A gastric pressing device that generates a tube-shaped part on the stomach wall that protrudes into the normal gastric cavity and is inserted into the gastric wall in the tube-shaped part of the gastric wall Wherein the pressing device comprises a vacuum device that aspirates the fundus and assists the instrument with the pressing device to form a tube-like part of the stomach wall, and ,true The device comprises a vacuum path leading from the proximal end to the distal end of the instrument, said vacuum path being divided into a plurality of small openings at the end of the instrument containing the pressing device, which sucks the stomach wall portion Attaching to the pressing device and forming a tube-like part of the stomach wall; the instrument comprises an insertion device adapted to introduce a volume filling device into the tube-like part of the stomach wall.

  Preferably, the device comprises at least one clamping device for holding the opening of the tube-like part in a substantially closed state by clamping between the stomach in the opening. Here, the instrument is adapted to arrange at least one clamping device on the opening in such a way that it can be subsequently sutured.

  Furthermore, preferably the instrument comprises an inflation device for inflating the volume filling device before or after suturing. Still further preferably, the instrument is adapted to suture an opening in a tube-like portion having a suture between the stomach to create an at least partially closed space that seals the volume filling device. The suturing device, wherein the instrument is adapted to be withdrawn with the volume filling device at least partially invaginated into the stomach wall.

  Preferably, the suturing device comprises first and second suturing positioning members provided at the distal end on an elongate member disposed in the stomach, wherein the instrument further comprises an operating device, The operating device adjusts the first and second suture positioning members so that the first and second suture positioning members are in front of each other with respect to the stomach wall on both sides of the open end of the cup-like portion. And is adapted to suture the open end of the cup-like portion of the wall by a series of sutures between the stomach and stomach.

  Preferably, the suturing device comprises an operable and reloadable multi-suture device, which can re-load the suture from outside the patient's body, and has an open end in the cup-like portion of the wall. , Adapted to suture by a plurality of suture sequences between the stomach and the stomach, the plurality of suture sequences including two or more sutures or staples that are stitched simultaneously.

  More preferably, the suturing device includes a plurality of sutures for simultaneously suturing two or more sutures.

The following method steps can be applied to any method or part of a method that is used in any combination and that uses any device or part of a device or any combination of features, the method comprising: One or more of the following operational method steps may be included:
-Introducing the device into the throat,
-Going through the esophagus,
-Filling the stomach with gas to expand the stomach,
-If the device is equipped with a camera, aspirate the fluid from the stomach while watching the guide video,
-Engaging the device with the stomach;
-Generating and suturing at least one sac in the stomach wall;
Filling the at least one sac with fluid and / or a volume filling device or two or more volume filling devices;
-Delivering a plurality of volume filling devices through the tube member to the sac created in the stomach tissue;
-Piercing the stomach wall with the above devices,
-Piercing the stomach wall with the instrument to position the volume filling device outside the stomach wall;
Piercing the stomach wall with the device for tube positioning that allows positioning of the subcutaneous injection port;
-Placing a subcutaneous injection port;
-Suturing or stapling the stomach wall from its inside to the esophagus;
-Suturing or stapling the stomach wall from the inside of the stomach to the stomach wall;
-Engaging the device with the esophagus;
-Suturing or stapling one layer of stomach tissue to one layer of esophageal tissue;
-Stitching or stapling two layers of stomach tissue to one layer of esophageal tissue;
-Stitching or stapling three layers of stomach tissue into one layer of esophageal tissue;
-Stitching or stapling four layers of stomach tissue into one layer of esophageal tissue;
-Stitching or stapling one or more layers of stomach tissue to two or more locations of esophageal tissue, the esophagus having a central axis of the esophagus, the esophagus being in relation to the central axis of the esophagus A first point along a first esophageal surface length axis substantially parallel to the central axis of the esophagus, further comprising a substantially cylindrical inner and outer surfaces extending radially; And a second along a second esophageal surface length axis substantially parallel to the esophageal central axis and spaced radially from the first esophageal surface length axis with respect to the esophageal central axis. To be attached to esophageal tissue both in terms of
-Delivery of the fixation member by a unit located in the device;
Piercing the fixation member into at least one layer of stomach tissue and one layer of esophageal tissue;
-Placing the fixation member above the gastroesophageal junction and creating a tunnel between the esophagus and the stomach above the junction;
-Positioning the esophagus part in the esophagus and the stomach part in the stomach;
-Placing the anchoring member substantially between the stomach part and the esophagus part;
-Inserting the device through the cardia into the main part of the gastric cavity and adapting the device to face the skull so that it reaches the position of the unit above the junction;
-When such a tunnel is created, it allows a virtually unlimited contraction and release of the sphincter closing the cardia.

The following method steps can be applied to any method or part of a method that is used in any combination and that uses any device or part of a device or any combination of features, the method comprising: One or more of the following operational method steps may be included:
-Cutting the patient's skin,
-Creating an opening in the patient's abdominal wall;
Introducing the device into the abdominal cavity through the opening in the abdominal wall;
-Engaging the device with the stomach;
-Withdrawing the device into the stomach wall to produce at least one preformed sac of the stomach wall;
-Clamping the stomach wall to produce at least one preformed sac of the stomach wall;
-Suturing or stapling at least one sac of the stomach wall;
Filling the at least one sac with fluid and / or a volume filling device or two or more volume filling devices;
-Delivering a plurality of volume filling devices through the tube member to the sac created in the stomach tissue;
-Penetrating the stomach wall into the stomach with the above equipment,
-Piercing the stomach wall with the instrument to position the volume filling device outside the stomach wall;
-Piercing the stomach wall with the above device to suture the stomach wall to the esophageal wall,
-Invagination of the volume filling device into the stomach wall,
-Placing a subcutaneous injection port;
-Suturing or stapling the stomach wall from the outside of the stomach to the stomach wall;
-Stitching or stapling the stomach wall from the outside of the stomach to the stomach wall without penetrating the mucosa,
-Stitching or stapling the two layers of the stomach wall to one or two layers of the stomach wall;
-Engaging the device with the esophagus;
-Clamping on both sides of the esophagus to secure one layer of the esophageal wall to one or two layers of stomach tissue;
-Clamping to both sides of the esophagus and the stomach wall at the bottom of the stomach to secure one layer of the esophagus wall to one or two layers of stomach tissue;
Introducing into the esophagus a tube or endoscopic device comprising an anvil member or a fixed delivery member involved in the fixation of the esophagus to the stomach;
-Aligning the position of the anvil member or fixed delivery member in the esophagus with respect to the device clamping around the esophagus;
-Suturing or stapling one layer of stomach tissue to one layer of esophageal tissue;
-Stitching or stapling two layers of stomach tissue to one layer of esophageal tissue;
-Stitching or stapling three layers of stomach tissue into one layer of esophageal tissue;
-Stitching or stapling four layers of stomach tissue into one layer of esophageal tissue;
-Using staplers with different stapling depths, stapling at different positions in the stapler row;
-Stapling the stomach into the esophagus with one first stapling depth and stapling the stomach into the stomach with a second stapling depth less than the first depth;
-Stapling the stomach-to-stomach sac with a stapler row, further comprising stapling the esophagus with a greater depth stapler included as part of the stapler row; Stapling,
-Stitching or stapling one or more layers of stomach tissue to two or more locations of esophageal tissue, the esophagus having a central axis of the esophagus, the esophagus being in relation to the central axis of the esophagus A first point along a first esophageal surface length axis substantially parallel to the central axis of the esophagus, further comprising a substantially cylindrical inner and outer surfaces extending radially; And a second along a second esophageal surface length axis substantially parallel to the esophageal central axis and spaced radially from the first esophageal surface length axis with respect to the esophageal central axis. To be attached to esophageal tissue both in terms of
-Delivery of the fixation member by a unit located in the device;
Piercing the fixation member into at least one layer of stomach tissue and one layer of esophageal tissue;
-Placing the fixation member above the gastroesophageal junction and creating a tunnel between the esophagus and the stomach above the junction;
-When such a tunnel is created, it allows a virtually unlimited contraction and release of the sphincter closing the cardia,
-Positioning the esophagus part in the esophagus and the stomach part in the stomach via introduction into the gastric cavity;
-Placing the anchoring member substantially between the stomach part and the esophagus part;
-Inserting the device through the cardia into the main part of the gastric cavity and adapting the device to face the skull so that it reaches the position of the unit above the junction;
In order to allow the device to be inserted into the main part of the gastric cavity, by operating the joint provided by the device to reach the position of the part of the unit of the esophagus above the joint; Bending the joint.

The following method steps can be applied to any method or part of a method that is used in any combination and that uses any device or part of a device or any combination of features, the method comprising: One or more of the following operational method steps may be included:
-Cutting the patient's skin,
-Introducing a tube through the abdominal wall,
Filling the abdominal cavity with fluid or gas,
-Introducing more than one trocar into the abdominal cavity,
Introducing the camera into the abdominal cavity through one of the trocars;
Introducing the device through the trocar into the abdominal cavity;
-Engaging the device with the stomach;
-Withdrawing the device into the stomach wall to produce at least one preformed sac of the stomach wall;
-Clamping the stomach wall to produce at least one preformed sac of the stomach wall;
-Suturing or stapling at least one sac of the stomach wall;
Filling the at least one sac with fluid and / or a volume filling device or two or more volume filling devices;
-Delivering a plurality of volume filling devices through the tube member to the sac created in the stomach tissue;
-Penetrating the stomach wall into the stomach with the above equipment,
-Piercing the stomach wall with the instrument to position the volume filling device outside the stomach wall;
-Piercing the stomach wall with the above device to suture the stomach wall to the esophagus,
-Placing the volume filling device outside the stomach wall,
-Invagination of the volume filling device into the stomach wall,
-Placing a subcutaneous injection port;
-Suturing or stapling the stomach wall from the outside of the stomach to the stomach wall;
-Stitching or stapling the two layers of the stomach wall to one or two layers of the stomach wall;
-Stitching or stapling the stomach wall from the outside of the stomach to the stomach wall without penetrating the mucosa,
-Engaging the device with the esophagus;
-Clamping on both sides of the esophagus to secure one layer of the esophageal wall to one or two layers of stomach tissue;
-Clamping to both sides of the esophagus and the stomach wall at the bottom of the stomach to secure one layer of the esophagus wall to one or two layers of stomach tissue;
Introducing into the esophagus a tube or endoscopic device comprising an anvil member or a fixed delivery member involved in the fixation of the esophagus to the stomach;
-Aligning the position of the anvil member or fixed delivery member in the esophagus with respect to the device clamping around the esophagus;
-Suturing or stapling one layer of stomach tissue to one layer of esophageal tissue;
-Stitching or stapling two layers of stomach tissue to one layer of esophageal tissue;
-Stitching or stapling three layers of stomach tissue into one layer of esophageal tissue;
-Stitching or stapling four layers of stomach tissue into one layer of esophageal tissue;
-Using staplers with different stapling depths, stapling at different positions in the stapler row;
-Stapling the stomach into the esophagus with one first stapling depth and stapling the stomach into the stomach with a second stapling depth less than the first depth;
-Stapling the stomach-to-stomach sac with a stapler row, further comprising stapling the esophagus with a greater depth stapler included as part of the stapler row; Stapling,
-Stitching or stapling one or more layers of stomach tissue to two or more locations of esophageal tissue, the esophagus having a central axis of the esophagus, the esophagus being in relation to the central axis of the esophagus A first point along a first esophageal surface length axis substantially parallel to the central axis of the esophagus, further comprising a substantially cylindrical inner and outer surfaces extending radially; And a second along a second esophageal surface length axis substantially parallel to the esophageal central axis and spaced radially from the first esophageal surface length axis with respect to the esophageal central axis. To be attached to esophageal tissue both in terms of
-Delivery of the fixation member by a unit located in the device;
Piercing the fixation member into at least one layer of stomach tissue and one layer of esophageal tissue;
-Placing the fixation member above the gastroesophageal junction and creating a tunnel between the esophagus and the stomach above the junction;
-When such a tunnel is created, it allows a virtually unlimited contraction and release of the sphincter closing the cardia.
-Positioning the esophagus part in the esophagus and the stomach part in the stomach via introduction into the gastric cavity;
-Placing the anchoring member substantially between the stomach part and the esophagus part;
-Inserting the device through the cardia into the main part of the gastric cavity and adapting the device to face the skull so that it reaches the position of the unit above the junction;
In order to allow the device to be inserted into the main part of the gastric cavity, by operating the joint provided by the device to reach the position of the part of the unit of the esophagus above the joint; Bending the joint.

  Any embodiment or part of an embodiment, and any method or part of a method, or any device or part of a device, or any feature or part of a feature, or any system or part of a system Note that can be combined in any applicable manner. All examples presented here are to be considered part of the general description and can therefore be combined in any way in a general sense.

  Those skilled in the art will be able to combine the steps, change the order of the steps, and the invention without any inventive effort and without departing from the scope of the invention as defined in the description and the claims. It should be understood that elements of different embodiments can be combined.

  It should be noted that all embodiments or features of embodiments, and any method or method step, can be combined in any manner, unless the combination is clearly incompatible. It should also be noted that the general description should be considered as describing both the apparatus and devices adapted to carry out the method and the method itself.

  Although particular embodiments of the present invention have been illustrated and described herein, many other embodiments can be envisaged and numerous additional advantages, modifications, without departing from the spirit and scope of the present invention. Obviously, and modifications will be readily made by those skilled in the art. Accordingly, the broader aspects of the present invention are not limited to the specific details, representative devices, and illustrated embodiments illustrated and described herein. Accordingly, various modifications can be made without departing from the spirit or scope of the general inventive concept as defined by the appended claims and their equivalents. Accordingly, it is to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit and scope of this invention. Numerous other embodiments can be envisioned without departing from the spirit and scope of the invention.

Claims (1)

A device for treating obesity in humans or mammals, said device comprising:
Comprising two or more volume filling devices forming an implantable volume filling device, wherein the v volume filling device is configured to be at least substantially invaginated into a stomach wall portion of a patient, and of the volume filling device The outer surface is positioned to rest against the stomach wall so that when the volume filling device is invaginated into the stomach wall, the volume of the food cavity is substantially greater than the volume of the volume filling device. The size of the
Furthermore, the device has moved away from the position where the volume filling device has been implanted and invaginated, and has been inadvertently stuck into the stomach wall and placed in the stomach (sticking into the stomach wall to hold the position in the stomach) The volume filling device is configured to be disassembled into the volume filling device segment, the volume filling device segment separately passing through the gastrointestinal tract, causing obstruction / intestinal obstruction in the patient's intestine A device for treating obesity, characterized in that it is configured to reduce risk