JP2020114509A - System for treating GERD - Google Patents

Abstract

To provide a regurgitation disease treatment apparatus having an implantable movement restriction device having elongated shape for keeping a cardia in a suitable position, and an implantable stimulus device adapted to be engaged with a patient's cardia sphincter.SOLUTION: A movement restriction device has a proximal end and a distal end. The distal end is adapted to stabilize and hold the distal end. A control device is provided for controlling a stimulus device to stimulate a cardia sphincter. The distal end can be further adapted for treating obesity, for example, by expanding a wall of a stomach, or filling the volume of a stomach.SELECTED DRAWING: Figure 49

Description

The present invention relates to a device for treating Gastroesophageal Reflux Disease (GERD).

SUMMARY OF THE INVENTION The present invention relates to a reflux disease treatment including an implantable elongated movement restriction device having a proximal portion that maintains the cardia in place and a distal portion that stabilizes the proximal portion and is additionally applicable to obesity treatment. Regarding the device. The apparatus may further include an implantable stimulation device adapted to be engaged with a patient's cardia sphincter, and a control device for controlling the stimulation device to stimulate the cardiac sphincter. The present invention may further be combined with various approaches to treating obesity, in particular by expanding the stomach wall to create a feeling of fullness or to fill the stomach volume.

Gastroesophageal reflux disease (GERD), or acid reflux disease, is a chronic condition that causes mucosal damage in the esophagus that is created by repeated acid reflux in the esophagus. This is generally due to a temporary or permanent change in the boundary between the esophagus and the stomach. This may be due to dysfunction of the lower esophageal sphincter (LES), temporary relaxation of LES, diminished function of eliminating gastric reflux from the esophagus, or hiatus hernia. There is.

Gastroesophageal reflux disease can be treated in a variety of different ways. Treatments include, but are not limited to, both medical and surgical treatments. The standard surgical treatment that may favor long-term use of the drug is Nissen fundoplication, where esophageal hiatus hernia is also used to strengthen the sphincter muscles to prevent acid reflux To cure, the upper curved portion (basal portion) of the stomach is wrapped around the LES. This procedure is often performed laparoscopically.

Another surgical treatment used is the Anglechik prosthesis, where a horseshoe-like device is placed over the esophagus above the cardia. The intended result here is to prevent the cardia from sliding upward into the chest cavity. However, this device has many complications, including traveling through and damage to the esophagus.

Experience with implanting medical devices has shown that sutures between the implanted device and human tissue do not last long. When implanting a device for an extended period of time, two things are possible to keep the device in place. The first solution is to suture human tissue to the human tissue, thereby keeping the device in place. Another approach is to perform suturing to hold the device in place for a short period of time, and ingrow human tissue into the device to hold the device in place for an extended period of time.

A problem with preparing implantable devices associated with the esophagus is that the outer surface of the esophagus is composed solely of esophageal muscle tissue that is very easily damaged and penetrated. This is probably one reason why many complications occur, such as device migration with the Anglechik prosthesis described above.

On the other hand, the stomach has a serosa on its outer side, thus forming a tougher membrane for suturing. Therefore, suturing the device directly to the stomach wall can provide better results than suturing the implantable device to the esophagus.

Currently, there is a need for a long-term treatment for GERD that is more effective than conventional treatments and does not cause serious complications.

It is an object of the present invention to overcome or at least reduce some of the problems associated with existing surgical treatment of gastroesophageal reflux disease (GERD). Another object of the invention is to provide a device for treating gastroesophageal reflux disease. These and other objects are met by the device as set forth in the appended claims.

It is an object of the present invention to provide a reflux disease treatment device with improved long-term properties, which may additionally be provided with an obesity treatment function.

This and other objects are achieved by the device as set forth in the appended claims. In general, the present invention relates to reflux disease in a human or mammalian patient that includes an implantable migration restriction device having an elongated shaped outer surface adapted to be at least partially invaginated by the gastric wall portion of the patient. A device for treating. The migration restriction device has a proximal portion and a distal portion when implanted in a patient, with the outer surface of the proximal portion at a location between the patient's diaphragm and the wall of the gastric fundus. It is adapted to rest at least partially against the wall of the patient's gastric fundus, so that the cardia notch of the patient's stomach may be affected by the patient if this movement restriction device is implanted in the patient. Of the cardia sphincter extending from the patient's abdomen, which prevents the cardia from sliding through the patient's diaphragm that is open into the patient's rib cage. Supportive pressure for cardia sphincter muscle) is maintained. The device also includes a distal portion adapted to be substantially invaginated in the stomach wall to prevent the cardia from sliding through the patient's diaphragm, which is open into the patient's rib cage. Is adapted to hold the proximal portion stable. The terms "proximal" and "distal" have their usual anatomical meanings. Therefore, the proximal position in the body structure means that it is close to the center of the body or at the beginning of the structure. In the present context, proximal and distal refer to the portions of the movement restriction device that are in the implantation position. The length of the invaginated distal portion of the elongate travel restriction device is long enough to stabilize the proximal portion of the elongate travel restriction device so that the cardia is open into the patient's rib cage. Sliding through the diaphragm is prevented. The circumference of the invaginated distal portion of the elongate travel restriction device is adapted to stabilize the proximal portion of the elongate travel restriction device, thereby allowing the cardia to open the diaphragm open into the patient's thorax. Sliding through is prevented. The proximal portion of the movement restriction device has a size of at least 125 mm ³ and at least 15
with a perimeter of mm.

Suitably, the apparatus comprises an implantable first fixation for fixing the proximal portion of the movement restriction device in a position that limits movement of the gastric cardia notch towards the patient's diaphragm. Including the device, the outer surface of the movement restriction device substantially contacts the wall of the gastric fundus of the patient. The first fixation device may include sutures or staples that tie together portions of the base gastric wall surrounding the proximal portion of the movement restriction device to secure the movement restriction device in the position described above. That is, the movement restriction device is at least partially disposed within the recessed space. Thus, indirectly attaching the proximal portion of the implantable migration restriction device in this manner eliminates the need for sutures between the migration restriction device and tissue, reducing the risk of complications. Maintaining the proximal portion of the movement restriction device in place in this manner provides a resilient suspension with improved long term properties.

A first fixation device, such as a suture or staple, ties together portions of the basal gastric wall to incise the proximal portion of the movement restriction device from either the inside or outside of the patient's stomach wall.

Alternatively, a tissue growth promoting structure may be sutured to the stomach wall with the relatively large contact surface facing the stomach. The relatively large surface of this structure, such as the net, allows in-growth of human tissue to hold the proximal portion of the movement restriction device in place for extended periods of time. The tissue growth promoting structure may include sutures or staples that attach the net-like structure to the underlying gastric wall.

In addition to attaching the proximal portion of the movement restriction device to the stomach wall, a second fixation device may be employed. The second fixation device may be used to attach the proximal portion of the movement restriction device to the cardia. For example, the proximal portion of the movement restriction device is secondarily attached, either directly or indirectly through the gastric wall at the base, to attach it at a location above the cardia, between the cardia and the diaphragm muscle. Can be done. The second fixation device may indirectly or directly approximate the His angle of the patient to secure the proximal portion of the movement restriction device to the wall of the patient's esophagus. The second fixation device preferably includes a plurality of sutures or staples that tie the base wall to the patient's esophageal wall to hold the movement restriction device in the position described above.

The apparatus may also include a third fixation device for indirectly or directly fixing the proximal portion of the movement restriction device to the patient's diaphragm muscle or another muscle tissue. The third fixation device preferably comprises a plurality of sutures or staples that tie the wall of the base to the diaphragm muscle or another muscle tissue to hold the movement restriction device in the position described above.

The proximal portion of the movement restriction device is substantially or completely invaginated by the wall of the gastric fundus of the patient, and is further positioned either inside or outside the wall of the gastric fundus. May be adapted.

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

At least a portion of the proximal portion of the movement restriction device may be made of a material that may or may not be destroyed by gastric acid.

In one embodiment, the proximal portion of the movement restriction device is inflatable and is adapted to be inflated with a gel or fluid. A fluid or gel containing member may be provided for containing a fluid for inflating the movement restriction device.

The proximal portion of the movement restriction device may include a homogeneous material and may be solid.

The proximal portion of the movement restriction device may include an enclosure defining a chamber.

The proximal portion of the movement restriction device may have a rigid, elastic or flexible outer wall. When the outer wall is rigid, the outer wall has a rigidity high enough to maintain a state in which it does not deform even when subjected to the force generated by the movement of the stomach.

According to a preferred embodiment of this device, the proximal portion of the movement restriction device has an outer surface adapted to be at least partially invaginated by the wall of the gastric fundus of the patient and which comprises a biocompatible material. Has a body adapted to. An essential portion of the outer surface of the body is adapted to rest against the gastric wall at the location between the patient's diaphragm and the lower portion of the invaginated gastric base wall. Suitably, the body is made of a material that is softer than shure hardness 25 or 15.

According to a first schematic design of the body, the body has a maximum perimeter found in a plane perpendicular to the axis passing through the body. The perimeter of the body seen in another plane perpendicular to the axis is equal to the maximum perimeter or decreases in the direction along the axis starting from the maximum perimeter. For example, the body may be substantially oval, spherical, or substantially ovoid with a depressed central section or bent oval.

According to a second schematic design of the body, the circumference of the body seen in a plane perpendicular to the axis passing through the body increases or decreases at least twice as the plane is displaced along said axis, or Alternatively, it decreases and increases at least once as the plane is displaced along the axis. For example, the body may be substantially kidney-like shaped.

Suitably, the body is sized to have a size greater than the exit of the intestinal tract from the stomach. The body may have a minimum outer diameter of 30 mm or 40 mm or greater and a minimum outer circumference of 150 mm, 110 mm, 90 mm, 70 mm, 50 mm or 30 mm.

Suitably, the body has a rounded profile without overly sharp edges that would damage the patient's stomach wall, and has a generally smooth outer surface to rest against the base wall.

The body is implantable inside or outside the patient's stomach and is adapted to be surgically attached to the patient's stomach wall. The body may be deformable so that it can assume an elongated shape having a diameter smaller than the diameter of the trocar used for laparoscopy, whereby the body is deformed into the elongated shape as described above. It can be pushed and pulled through the trocar while in motion. The body may include a flexible outer wall defining a chamber filled with a fluid such as a gel, which allows the body to pass through a trocar as described above. Alternatively, the body may include a compressible elastic material that allows the body to pass through the trocar.

The body may be hollow, at least adapted to be inserted into the hollow body and further adapted to be combined into one single piece (singularized piece) inside the body. It may include two separate pieces, which allow the body to pass through a trocar used for laparoscopy. Alternatively, the body may have an outer wall and a hollow compression inner portion for being filled with a fluid or gel after being inserted into the patient's body.

The body may have a chamber with an injection port, the chamber of the body being filled with fluid via the injection port.

The body can have at least one retention device adapted to be used to push and pull the body through a trocar used for laparoscopy. The retaining device is adapted to retain an additional portion of the body adapted to be retained by the surgical instrument. More specifically, the retaining device is adapted to retain a thread or band inserted through the retaining device. If the body has an outer wall, the retaining device is located at least partially inside the outer wall of the body.

In one embodiment, the device according to the invention further comprises an adjusting device for adjusting at least the proximal part of the movement restriction device. To this end, the movement restriction device may have a body that is hydraulically adjustable in size, the adjustment device including a hydraulic fluid reservoir connected to the body when implanted in a patient. The size of the body may be adjusted non-invasively by manually pressing the hydraulic fluid reservoir, thereby providing an amount of hydraulic fluid supplied to the body as well as a size of the body. Is adjusted. The apparatus may further include a hydraulic adjustment device including at least one chamber that is recessed into the patient's stomach wall and connected to the body with the body when implanted in the patient. The amount of hydraulic fluid contained is adjusted non-invasively by distributing the fluid between the hydraulic reservoir and the at least one chamber. Preferably, the at least one chamber is filled with hydraulic fluid using a pump in the reservoir when implanted in the patient, thereby expanding the base wall to give the patient a feeling of fullness. .. Also, the regulation device can further have a reverse servo, where the chamber moves a large amount with less force per unit volume when a small amount of fluid in the reservoir is squeezed with a strong force. .. In one embodiment, the body forms a first chamber and further comprises at least one additional body forming a second chamber that is smaller than the first chamber, the first and second chambers being separated from each other. They are connected and preferably in fluid communication with each other. The hydraulic reservoir is preferably adapted to be placed subcutaneously in the patient, preferably in the abdomen of the patient. The hydraulic reservoir may have a wall defining its volume, the volume of the hydraulic reservoir being adjusted by moving a wall portion of the wall of the hydraulic reservoir. The device can have a motor for moving the wall portion. The hydraulic adjustment device may have a pump, the hydraulic reservoir being adjusted by the pump forcing fluid between the hydraulic reservoir and the at least one chamber. A mechanical device that is moved when the hydraulic adjustment device is activated may be operably connected to the hydraulic adjustment device. In one embodiment, at least the proximal portion of the movement restriction device is mechanically adjusted. The device may further include a motor for mechanically adjusting the movement restriction device.

In one embodiment, the device according to the invention is for implanting with a body into a patient two volumes of each of two different sites of the patient's stomach, thereby affecting the patient's reflux. It further has a second body. The reflux disease treatment device is adapted to be adjusted non-invasively post-operatively, and one filling body first fills the volume of one site of the stomach and then the other filling body of the stomach. It is adapted to be adjusted over time to fill the volume of one site.

In one embodiment, the device according to the invention comprises an adjusting device for adjusting the size and/or the shape of the movement restriction device. The size of the movement restriction device is hydraulically adjustable, and the adjustment device can have a hydraulic fluid reservoir that is connected to the movement restriction device when implanted in the patient. Size can be adjusted non-invasively by moving hydraulic fluid between the hydraulic fluid reservoir and the movement restriction device. The movement restriction device may be considered as the main body. The apparatus may further include a hydraulic adjustment device including at least one chamber that is recessed into the patient's stomach wall and connected to the body with the body when implanted in the patient. The amount of hydraulic fluid contained is adjusted non-invasively by distributing the fluid between the hydraulic reservoir and the at least one chamber. At least one chamber is filled with hydraulic fluid using a pump in the reservoir when implanted in a patient, thereby expanding the wall of the base and providing the patient with a feeling of fullness. The conditioning device can also have a reverse servo that includes three adjustable reservoirs with hydraulic fluid, where the subcutaneous is part of a first closed system that includes a second reservoir. A small amount of fluid in the first reservoir, which is located at, is squeezed with a strong force per unit area to move a small amount of hydraulic fluid, and the second reservoir has a larger volume than the first reservoir. It acts on a large amount of hydraulic fluid in a third reservoir, which is part of the second closed system, thereby allowing a weaker force per unit area to move a larger total amount of hydraulic fluid. it can.

In certain embodiments, the migration repair device outlined above is adapted to be assembled to make a size-adjustable, implantable, assembled migration restriction device that includes at least a proximal portion of the migration restriction device. It has two or more movement restriction device segments, preferably three or more segments. The assembled movement restriction device is adapted to rest at least a portion of its outer surface facing the patient's gastric basal wall at a position between the patient's diaphragm and the basal wall, such that , Limiting the movement of the cardia notch in the patient's stomach toward the patient's diaphragm when the movement restriction device is implanted in the patient, thereby opening the cardia into the patient's thorax. It is prevented from sliding through the patient's diaphragm while maintaining a supportive pressure on the patient's cardiac sphincter extending from the patient's abdomen. The assembled movement restriction device is preferably disassembled into a plurality of segments away from the implantation position of the at least partially contracting gastric basal wall, which is located between the diaphragm and the basal wall. Is adapted as Preferably, the assembled movement restriction device is adapted to be invaginated in the stomach wall, and further away from the implantation position of the stomach, including the position of penetrating the stomach to hold the position inside the stomach. , Adapted to be decomposed into a plurality of segments. These segments are preferably adapted to individually pass through the food passages, thereby reducing the risk of obstruction/ileus in the patient's intestine. The movement restriction device segment may be adapted to pass through the trocar for assembly and for implanting the movement restriction device intraperitoneally. The movement restriction device segment can have a flexible profile adapted to pass through the trocar. The movement restriction device segment can be adapted to have a shape such that it can be assembled to make the movement restriction device when implanted. In one embodiment, the movement restriction device segment is hollow with a flexible outer surface. The movement restriction device segment may be adapted to be filled with at least one fluid, foam, gel, or fluid that hardens into a solid material. In one embodiment, the movement restriction device segment is solid. The movement limiting device segments are preferably adapted to temporarily hold their assembled position, preferably by the invaginated stomach wall or alternatively by an adhesive.

The movement restriction device comprises at least one assembly element that is fully fitted to at least one assembly element of another segment for assembly, wherein the plurality of segments are assembled by mating the assembly element. And thereby create an implantable movement restriction device. For this purpose the segment preferably comprises a core portion and a plurality of outer portions, preferably at least one assembly element is selected from a well-fitting flange and slit. The core portion is adapted to receive and assemble the outer element to create an implantable movement restriction device, preferably the core portion is a corresponding assembly flange of the outer portion during assembly of the movement restriction device. Having an assembly slit adapted to receive. In one embodiment, the slits are arranged around the outer peripheral region of the core portion. In that case, the outer part is provided with a flange that fits well into the slit for assembling the device. In another embodiment, at least one assembly element immobilizes each of the movement restriction devices relative to the core portion along a first plane, the movement restriction device and the core portion further comprising a second assembly element. , The second assembly element immobilizes each segment and core portion along a second plane angled with respect to the first plane when the segment and core portion are assembled. .. For example, the first plane and the second plane may be substantially vertical. The second assembly element has a mating element, which preferably comprises adapted protrusions and recesses provided on the movement-restricting device segment and the core part, at least one assembly element further having protrusions and recesses. Preferably, the at least one assembly element comprises an assembly slit in the core portion and an assembly flange in the segment, and the mating element comprises a protrusion in the slit and a recess in the flange. Alternatively, at least one assembly element includes an assembly flange in the core portion and an assembly slit in the segment, and the mating element includes a protrusion in the slit and a recess in the flange.

In one particular embodiment, the apparatus preferably further comprises a guiding device operable to assemble the movement restriction device segment to the implantable movement restriction device. Suitably, the inductive device is a steering wire operably connected to the segment.

The manipulation wire may be made of a biodegradable material that contacts fluid in the abdominal cavity to help break down the movement restriction device into multiple segments. To assist in the assembly procedure, each segment may be provided with at least one assembly element that is fully fitted to at least one assembly element of another segment, with the plurality of mating elements being fitted together. The segments can be assembled, thereby creating an implantable movement restriction device. In one embodiment, the segment includes a core portion and a plurality of outer portions, and in one embodiment the assembly element is selected from a well-fitting flange and slit.

The core portion is preferably adapted to receive and assemble the outer element to create an implantable movement restriction device. In one embodiment, the core portion has an assembly slit adapted to receive a corresponding assembly flange of the outer portion during assembly of the movement restriction device. Suitably, the slits are arranged around the outer peripheral region of the core part. These slits and flanges keep the segments together as a movement restriction device in its implantation position and also disassemble the movement restriction device if the movement restriction device accidentally leaves its position, for example, into the gastric cavity. It may be designed to form a clearance fit adapted to assist in fitting. In such cases, degradation of the guidance device and disassembly of the movement restriction device into multiple segments designed to not cause any atresia or otherwise injure the patient at all. Help you to do.

To assemble a plurality of segments, a manipulation wire can be connected to the core portion and the outer portion, then the outer portion can be assembled to the core portion, and the movement restriction device is assembled. For this purpose, the operating wire is preferably connected to the assembly flange of the outer part and the core part is preferably provided with at least one operating channel for receiving the operating wire. Suitably, each outer portion is connected to two operating channels by an operating wire. In one embodiment, the first operating channel has a first orifice in the end face of the core portion and further has a second orifice in the first slit of the core portion, and within the first operating channel. When displacing the received operation wire in the direction starting from the end surface, the first outer portion is assembled to the core portion. The second operation channel has two orifices in the second slit of the core portion, and when the operation wire connected to the first operation channel is displaced in the direction starting from the end face, The outer part of the core is assembled to the core part. Suitably, the guide wire projects from the orifice of the first channel and can therefore be manipulated by an instrument for displacing the guide wire and the first outer element, such that its assembly flange has a core element. The implantable movement restriction device is assembled by fitting in the designated first assembly slit above and displacing the remaining outer elements in a predetermined order in a similar manner. The segment may include three or more outer portions that assemble into designated slits in the core portion, with a guide wire passing through an operating channel having an orifice in each designated slit in the core portion. .. In one embodiment, the movement restriction device has one core portion and four outer portions. However, it is also possible for the person skilled in the art to design the segments in different ways within the scope of the present invention. The movement restriction device thus assembled can maintain a generally spherical shape, although other shapes and additional functional elements may be made as part of the present invention, as described below.

The following section description describes additional features of the proximal portion of the movement restriction device. These features may be combined with any of the following features associated with the distal portion of the movement restriction device.

In an advantageous embodiment of the device, which is further adapted here to treat obesity, the body is adjustable in size and is invaginated in the stomach wall at the base of the patient. As a result, the body widens the basal wall of the patient's stomach when its size is increased, thereby giving a patient who is also suffering from obesity a feeling of fullness. At least two implantable and adjustable expansion devices may be provided to widen another part of the patient's stomach wall, thereby treating obesity by effectively affecting the patient's appetite. .. These two dilation devices are preferably adjusted from outside the patient's body, whereby the first dilation device is first adjusted to open the first portion of the patient's stomach wall and then the second dilation device. The device is adjusted to open the second portion of the patient's stomach wall.

Since patients are commonly suffering from both obesity and reflux disease, the device of the present invention can be further adapted to be able to treat obesity with reflux disease in any of the forms outlined above. .. To this end, the distal portion of the movement restriction device is further adapted to treat obesity. The distal portion has the function of a volume filling device.

According to a first option, the distal portion of the movement restriction device is adapted to be placed inside the stomach with the outer surface of the distal portion stationary facing the inside of the stomach wall.

According to a second option, the distal portion of the movement restriction device is adapted to be positioned outside the stomach with the outer surface of the volume filling device stationary facing the outside of the stomach wall.

Preferably, the distal portion of the movement restriction device is adapted to be completely invaginated by the patient's stomach wall and to be placed inside or outside the stomach wall via a gastroscopic instrument. .. To this end, the distal portion of the movement restriction device may have an attachment device adapted to cooperate with the gripping instrument. Suitably, the distal portion of the movement restriction device is adapted to be non-invasively adjustable post-operatively.

The device may have one fixation device, preferably two or more fixation devices adapted to participate in fixing the distal portion of the movement restriction device to the stomach wall. The distal portion of the movement restriction device may have one retention device, preferably two or more retention devices, adapted to be retained by the instrument to facilitate implantation of the device.

At least a portion of the distal portion of the movement restriction device may be made of a material that is not degraded by gastric acid. The distal portion of the movement restriction device may be degradable by an acid such as hydrochloric acid.

In one embodiment, the distal portion of the movement restriction device is inflatable to an expanded state and has an enclosure defining a chamber, wherein the distal portion of the movement restriction device is a gel or fluid supplied within the chamber. Is inflated by. At least one tube may be connected to the distal portion of the movement restriction device to provide a gel or fluid to the chamber. An injection port connectable to the tubing may be provided. Alternatively, the distal portion of the movement restriction device may be provided with an inlet port for a fluid or gel connectable to the gastroscopy instrument, where the inlet port is the inflatable device and the gastroscopy instrument. Has a fluid connection adapted to interconnect.

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

At least one of the distal and proximal portions of the movement restriction device may at least partially have a rigid, elastic or flexible outer surface. When the outer surface is rigid, the outer surface has such a high rigidity that it remains undeformed when subjected to the force generated by the movement of the stomach. The distal portion of the movement restriction device may include a flexible inelastic material.

According to a first schematic design of the distal portion of the movement restriction device, the device has a maximum perimeter found in a plane perpendicular to the axis through the device. The perimeter of the device, as seen in another plane perpendicular to the axis, is equal to the maximum perimeter or decreases as seen in a direction starting from the maximum perimeter along the axis. For example, the device may be substantially oval, spherical, or substantially ovoid with a concave central section or curved oval.

According to a second schematic design of this device, does the perimeter of the device seen in a plane perpendicular to the axis through the device increase or decrease at least twice as the plane is displaced along said axis? , Decrease and increase at least once as the plane is displaced along said axis. For example, the device may be substantially kidney-like shaped.

The distal portion of the movement restriction device has an elongated shape, a circular shape, a bent shape and/or a curved shape.

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

The distal portion of the movement restriction device, 0.0001 m ³ from 0.001 m ^3, or, 0.001 m ³ from 0.00001M ^3, or have a volume in the range from 0.00001M ³ of 0.0002 m ^3. The volume of the volume filling device is less than 0.0002 m ³ .

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

The distal portion of the movement restriction device may include elastic material, biocompatible material and/or silicone. Suitably, at least one layer is provided on at least one of the distal and proximal portions of the movement restriction device. For example, a metal layer, a parylene layer, a polytetrafluoroethylene layer or a polyurethane layer. These layers may include multiple layers in any order. Suitably one of these layers may be made of metal, silicon or PTFE. The volume filling device may have an outer surface layer of silicone, polyurethane, Teflon® or polytetrafluoroethylene, metal, parylene, PTFE, or combinations thereof. The volume filling device may have an inner surface layer of silicone, polyurethane, Teflon® or polytetrafluoroethylene, metal, parylene, PTFE, or combinations thereof. Another combination of layers includes an inner surface layer of polytetrafluoroethylene and an outer layer of silicone, an inner layer of polytetrafluoroethylene and an intermediate layer of silicon and an outer layer of parylene, an inner layer of polyurethane and an outer layer of silicone, And an inner surface layer of polyurethane and an intermediate layer of silicone and an outer layer of parylene.

The distal portion of the movement restriction device may include a fluid adapted to be transformed into a solid phase or fixed form. The fluid may be liquid polyurethane, i.e. isotonic. The fluid may contain macromolecules such as iodine molecules to prevent diffusion.

The distal portion of the movement restriction device may have a maximum circumference of at least 50 millimeters, preferably at least 80 millimeters. Preferably, the distal portion of the movement restriction device is deformable to a maximum diameter so that it can be inserted into a laparoscopic trocar.

Preferably, the distal portion of the movement restriction device is adapted to be held in place by gastro-gastric sutures or staples for invagination of the device into the stomach wall. Advantageously, the distal portion of the movement restriction device has a perimeter that varies to better maintain it in place when invaginated in the patient's stomach wall. Stomach-A stomach-suture or staple is formed with a structure adapted to contact the stomach wall for promoting in-growth of human tissue and for long-term fixation of the position of a volume filling device attached to the stomach wall. A fixed part may be provided. The structure may include a net-like structure.

In an embodiment of the invention, the device comprises an expansion device arranged outside the stomach wall, adapted to widen a part of the stomach wall in order to influence the patient's appetite. If the volume filling device is inflatable, the apparatus may have a fluid connection that interconnects the expansion device and the volume filling device.

The expansion device can be hydraulically adjusted. In this case, a subcutaneously implantable hydraulic reservoir may be provided that is connected to the hydraulically controlled expansion device, whereby the hydraulically controlled expansion device is implanted in the patient. When adapted to be adapted to be adjusted non-invasively using the fluid from the hydraulic reservoir. In one embodiment, the hydraulically adjusted dilation device is non-invasively adjusted by manually depressing the hydraulic reservoir. Also, the movement restriction device preferably has an inflatable body, and is further provided with a pump and a chamber in fluid contact with the inflatable body, the pump pushing a fluid or air from the body into the chamber to create a hydraulic reservoir. Adjust.

The device has an implantable stimulation device that delivers stimulation pulses to the cardia muscle, particularly the cardia sphincter, to stimulate the cardia muscle, thereby further closing the cardia and additionally preventing reflux disease. You can The stimulation device comprises at least one electrical conductor and at least one electrode rod that receives stimulation pulses and applies those stimulation pulses to the cardiac sphincter to stimulate the cardiac sphincter. The at least one electrode rod is also maintained in place by a stomach-oesophageal suture or by invagination in the stomach wall. The stimulation pulses may be sent as a series of pulses, with the pulse train repeating with a time break extending the break between each pulse of the pulse train. Preferably, the stimulation device delivers multiple pulse trains in succession, after which a break longer than the break between pulse trains is placed to rest the muscles and keep the cardiac sphincter closed. The stimulation device may have an electronic circuit and an energy source, and is preferably adapted to incorporate the electronic circuit and the energy source.

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

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

A sensor for sensing an esophageal contraction wave or any other parameter related to the food taken in sends information to the internal control unit, which then stops stimulation in response to such information from the sensor. ..

The stimulation device can always be controlled by the patient.

This object is also achieved by providing an apparatus that includes an implantable movement restriction device having an elongated shape and having a proximal portion and a distal portion when implanted in a patient, where The proximal portion is adapted to be at least partially invaginated by the wall of the gastric fundus of the patient and has an outer surface that preferably comprises a biocompatible material, where the proximal portion of the movement restriction device is proximal. A substantial portion of the outer surface of the portion faces the stomach wall at a location between the patient's diaphragm and at least a portion of the lower portion of the invaginated basal wall so as not to damage the stomach wall. It is adapted to rest so that the cardia notch of the patient's stomach is restricted from moving towards the patient's diaphragm when the movement restriction device is invaginated, whereby the cardia is Sliding through the patient's diaphragm, which is open into the patient's thorax, is prevented and supportive pressure is maintained on the patient's cardia sphincter extending from the patient's abdomen. The distal portion of the movement restriction device stabilizes and holds the proximal portion and is adapted to be substantially invaginated in the stomach wall. The basal stomach wall can be moved more easily and is thus stabilized by the distal portion which is at least partially invaginated below the basal stomach wall. The proximal portion of the movement restriction device has a size of at least 125 mm ³ and a perimeter of at least 15 mm, and further comprises an implantable stimulation device adapted to engage the cardiac sphincter of the patient and stimulation of the cardiac sphincter. And a control device for controlling the stimulator device to provide, wherein stimulation to the cardia sphincter is created by an energy pulse to enhance the tonus of the sphincter muscle so that the cardia is closed, said control The device is operable by the patient and thus can be set to stop, wherein the control device is further operable by the patient to set the stimulating device in the operative state, in which the stimulating device is , When the patient is not swallowing, the cardiac sphincter continuously alternates between a mode of operation in which the energy pulse is stimulated and a resting mode in which the cardiac sphincter is not stimulated.

(Movement restriction device)
A device movement limitation device will be described. In this context, it should be understood that all features, functions or suitability described herein with the movement restriction device are related to the proximal portion even if not explicitly mentioned. However, all features, embodiments, or portions of embodiments described herein, as well as any method, are used for both the proximal or distal portions of the device, where applicable. obtain.

The device includes an implantable migration restriction device having an outer surface comprising a biocompatible material, wherein the migration restriction device is at least between its outer surface at a location between the patient's diaphragm and the base wall. A portion is adapted to rest with the patient's basal wall facing the wall, which limits the movement of the cardia notch of the patient's stomach toward the patient's diaphragm, which may cause gastroesophageal reflux disease. A device for treatment is obtained. The movement restriction device has a size of at least 125 mm ³ and a perimeter of at least 15 mm to limit movement of the cardia notch of the patient's stomach toward the patient's diaphragm, thereby causing the cardia into the patient's thorax. To prevent sliding through the patient's open diaphragm and maintain support pressure on the patient's cardia sphincter extending from the patient's abdomen. A locking device is adapted to lock the movement restriction device in the above position.

By adapting the outer surface of the implanted movement restriction device to rest against the wall of the base, the base is less fragile than the esophagus, thus risking complications such as increased tissue damage Is the smallest.

In a first embodiment of the invention, the fixation device includes sutures or staples that tie together portions of the surrounding base gastric wall of the movement restriction device to secure the movement restriction device in the position described above. That is, the movement restriction device is at least partially disposed within the recessed space. Thus, by indirectly attaching a movable movement restriction device in this manner, sutures are not required between the movement restriction device and tissue, further reducing the risk of complications. Maintaining the movement restriction device in place in this manner creates an elastic suspension with improved long term properties.

A fixation device, such as a suture or staple, may tie together portions of the base gastric wall to substantially or completely invagin the movement restriction device from either the inside or outside of the patient's gastric wall. it can. When the movement restriction device is positioned outside the patient's stomach wall, the movement restriction device is invaginated by the base gastric wall and the gastric cavity is substantially reduced by a volume that substantially exceeds the volume of the movement restriction device. ..

In another embodiment of the invention, the fixation device comprises an implantable first fixation device that attaches the movement restriction device to the wall of the base in the above position and the movement restriction device closer to the His angle of the patient's esophagus. And a third fixation device for indirectly or directly fixing the movement restriction device to the patient's diaphragm muscle or related muscles. Any of the first, second and third fixation devices may be comprised of a plurality of sutures or staples. The first fixation device may have a tissue growth promoting structure for attaching the movement restriction device to the stomach wall over an extended period of time. The tissue growth promoting structure may be sutured to the stomach wall with the relatively large contact surface facing the stomach. The relatively large surface of this structure, such as a net, allows in-growth of human tissue to hold the movement restriction device in place for extended periods of time. The tissue growth promoting structure may include sutures or staples that attach the net-like structure to the underlying gastric wall.

In addition to invagination of the travel restriction device according to the first embodiment of the present invention, a second fixation device secures the travel restriction device indirectly or directly to the esophagus by approaching the His angle of the patient. A third fixation device may also be used to indirectly or directly fix the movement restriction device to the patient's diaphragm muscle or another muscle tissue.

At least a portion of the movement restriction device may be made of a material that may or may not be destroyed by gastric acid.

The movement restriction device is inflatable and is adapted to be inflated with a gel or fluid. A fluid or gel containing member may be provided for containing a fluid for inflating the movement restriction device.

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

The movement restriction device may include an enclosure defining a chamber.

The movement restriction device may have a rigid, elastic or flexible outer side. When the outer side is rigid, the outer wall has such a high rigidity that it can maintain a state in which it does not deform under the force generated by the movement of the stomach. If the movement restriction device is invaginated, according to the first embodiment described above, the movement restriction device is preferably adapted to be at least partially invaginated by the wall of the gastric fundus of the patient. And a body adapted to have an outer surface comprising a biocompatible material. A substantial portion of the outer surface of the body is adapted to rest against the stomach wall at the location between the patient's diaphragm and the lower portion of the invaginated gastric base wall. Suitably, the body is made of a material softer than 25 or 15 shure.

According to a first schematic design of the body, the body has a maximum perimeter found in a plane perpendicular to the axis passing through the body. The perimeter of the body is equal to the maximum perimeter, as seen in another plane that is perpendicular to the axis, or decreases, as seen in the direction of origin from the maximum perimeter along the axis. For example, the body may be substantially oval, spherical, or substantially ovoid with a depressed central section or bent oval.

According to a second schematic design of the body, the circumference of the body seen in a plane perpendicular to the axis passing through the body increases or decreases at least twice as the plane is displaced along said axis, or It decreases and increases at least once as the plane is displaced along the axis. For example, the body may be substantially kidney-like shaped.

Suitably, the body is sized to have a size greater than the exit of the intestinal tract from the stomach. The body may have a minimum outer diameter of 30 mm or 40 mm or greater and a minimum outer circumference of 150 mm, 110 mm, 90 mm, 70 mm, 50 mm or 30 mm.

Suitably, the body has a rounded profile without overly sharp edges that would damage the patient's stomach wall, and has a generally smooth outer surface to rest against the base wall.

The body is implantable inside or outside the patient's stomach and is adapted to be surgically attached to the patient's stomach wall. The body may be deformable so that it can assume an elongated shape having a diameter smaller than the diameter of the trocar used for laparoscopy, whereby the body is deformed into the elongated shape as described above. It can be pushed and pulled through the trocar while in motion. The body may include a flexible outer wall defining a chamber filled with a fluid such as a gel, which allows the body to pass through a trocar as described above. Alternatively, the body may include a compressible elastic material that allows the body to pass through the trocar.

The body may be hollow and comprises at least two separate pieces adapted to be inserted into the hollow body and adapted to be combined into one single piece inside the body. It may be, which allows the body to pass through the trocar used for laparoscopy. Alternatively, the body may have an outer wall and a hollow compression inner portion for being filled with a fluid or gel after being inserted into the patient's body.

The body may have a chamber with an injection port, the chamber of the body being filled with fluid via the injection port.

The body can have at least one retention device adapted to be used to push and pull the body through a trocar used for laparoscopy. The retaining device is adapted to retain an additional portion of the body adapted to be retained by the surgical instrument. More specifically, the retaining device is adapted to retain a thread or band inserted through the retaining device. If the body has an outer wall, the retaining device is located at least partially inside the outer wall of the body.

In an advantageous embodiment, the body is adjustable in size and is invaginated in the stomach wall at the base of the patient. As a result, the body can widen the walls of the patient's gastric fundus as its size is increased, thereby giving a patient who also suffers from obesity a feeling of fullness. At least two implantable and adjustable expansion devices may be provided to widen another part of the patient's stomach wall, thereby treating obesity by effectively affecting the patient's appetite. .. These two dilation devices are preferably adjusted from outside the patient's body, whereby the first dilation device is first adjusted to open the first portion of the patient's stomach wall and then the second dilation device. The device is adjusted to open the second portion of the patient's stomach wall.

The expansion device can be hydraulically adjusted. In this case, a subcutaneously implantable hydraulic reservoir may be provided which is connected to the hydraulically adjusted expansion device, whereby the hydraulically adjusted expansion device manually operates the hydraulic reservoir. It is adjusted non-invasively by pressing. Also, the movement restriction device preferably has an inflatable body and is further provided with a pump and a chamber in fluid contact with the body, the pump regulating the hydraulic reservoir by pushing fluid or air from the body into the chamber. ..

The device may include an implantable stimulation device that delivers stimulation pulses to the cardia muscle to stimulate the cardia muscle, thereby further closing the cardia and additionally preventing reflux disease. The stimulation device consists of at least one electrical conductor and at least one electrode rod that receives stimulation pulses and applies those stimulation pulses to the cardia muscle to stimulate the cardia muscle. The at least one electrode rod is also maintained in place by stochach-oesophagal sutures or by invagination into the stomach wall. The stimulation pulses may be sent as a series of pulses, with the pulse train repeating with a time break extending the break between each pulse of the pulse train. The stimulation device may have an electronic circuit and an energy source, and is preferably adapted to incorporate the electronic circuit and the energy source.

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

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

A sensor for sensing an esophageal contraction wave or any other parameter related to the food taken in sends information to the internal control unit, which then stops stimulation in response to such information from the sensor. ..

The stimulation device can always be controlled by the patient.

(Stimulation device)
Next, the stimulation device of the apparatus will be described.

The control device is operable by the patient to control the stimulation device to continuously alternate between a mode of operation in which the cardiac sphincter is stimulated by energy pulses and a rest mode in which the cardiac sphincter is not stimulated. is there. (The term "patient" includes an animal or a human.) The continuous alternation of operating and rest modes allows the cardia sphincter to "recover" while in rest mode, resulting in movement. It has the advantage of being more sensitive in mode. Another advantage is that the energy consumption of this new device can be significantly reduced compared to the conventional continuous stimulation system discussed above. In addition, the control device is operable by the patient so that the patient can select the time for operating the device. For example, it may be sufficient for some patients, such as at night when the patient is lying down, to temporarily keep the device “on” when the patient feels an anomaly in regurgitation, while another patient May need to turn the device "on" at all times except when eating.

According to a preferred embodiment of the present invention, the apparatus has a source of energy, wherein the control device, when the stimulation device is implanted, provides the energy for the power-related use of the stimulation device. Control the source of energy to release. As a result, the device of the present invention allows for simple and effective control of the energy delivered to the implanted components of the device, potentially over the remaining life of the patient or at least for extended years. The device can be maintained for a long time and the reliability of its function can be guaranteed.

In a preferred embodiment, the control device is controllable from outside the patient's body to control the stimulation device to change the stimulation intensity of the cardiac sphincter over time. More specifically, the control device is adapted to control the stimulation device to alter the stimulation intensity of the cardiac sphincter muscle to change the tonus of the cardiac sphincter muscle. Preferably, the source of energy comprises an energy source and the control device is adapted to control the energy source for delivering electrical pulses to the stimulation device. An implantable switch may be provided to switch the supply of electrical pulses from the energy source. The switch may be manually operable by the patient, or alternatively the control device may have a wireless remote control operable by the patient to control the switch.

When the stimulation device uses electrical pulses to stimulate the cardiac sphincter, there is the problem that a voltage strength that is sufficient to provide the desired electrical stimulation to the cardiac sphincter must be achieved. This problem is due to the fact that the strength of the electrical stimulus may diminish over time, which increases electrical resistance due to fibrosis that occurs when the conductor is engaged with the cardia sphincter. It depends. This problem is solved by the main embodiment of the invention. Here, the stimulation device has an electrical conductor engaged to the cardia sphincter, and the energy power source is adapted to send an electric current through this electrical conductor, such that the control device controls the energy power source to release electrical energy. Is adapted so that the strength of the current through this conductor reaches a predetermined value. As a result, it is possible to compensate for the reduction in current strength due to fibrosis that occurs when the conductor is engaged in the cardia sphincter. Therefore, even if the current through the conductor is weakened, the control device automatically controls the energy source to release more electrical energy to restore the desired current strength.

Advantageously, the control device is adapted to control the energy source to release energy in the form of alternating current. The inventor has found that electrolysis occurs in the cardia sphincter when direct current is used instead of alternating current. Such electrolysis can damage the cardia sphincter.

All of the above embodiments may be combined with at least one implantable sensor for sensing at least one physical parameter of a patient, where the control device is responsive to a signal from the sensor. Can be controlled. Specifically, this sensor can sense the contraction wave of the esophagus that occurs when the patient swallows food as a physical parameter. In this case, the stimulation device is adapted to stop stimulating the cardiac sphincter in response to the sensor sensing the contraction wave of the patient's esophagus.

Alternatively, the sensor may comprise a pressure sensor for directly or indirectly sensing the pressure in the esophagus. The expression "indirectly sensing the pressure in the esophagus" should be understood as including the case where the sensor senses the pressure on the stimulation device or the human tissue of the patient.

The control device may have an internal control unit, preferably including a macro processor, implanted in the patient to control the stimulation device. The internal control unit is preferably capable of directly controlling the stimulation device in response to the signal from the sensor. In response to a signal from the sensor, such as pressure, patient position, contraction wave in the patient's esophagus, or any other important physical parameter, the internal control unit provides information about it external to the patient's body. Can be sent to. The control unit can also automatically control the stimulation device in response to the signal from the sensor. For example, the control unit can control the stimulation device to efficiently stimulate the cardia sphincter, which ensures that the cardia is fully responsive in response to a sensor that senses that the patient is lying down. To be closed.

Alternatively, the control device may have an external control unit external to the patient's body, in which case the internal control unit is programmable by the external control unit, for example to control the stimulation device over time. is there. Alternatively, the internal control unit may control the stimulation device over time according to an operating schedule program that may be adapted to the patient's needs.

The extracorporeal control unit may also preferably directly control the stimulation device in response to the signal from the sensor. The extracorporeal control unit may store information regarding the physical parameter sensed by the sensor and may be manually operated to control the stimulation device based on the stored information. In addition, there may be at least one implantable transmitter for sending information regarding the physical parameter sensed by the sensor.

A great advantage is that the patient can use the control device to keep the cardia fully closed by the stimulation device at any time the patient desires. This advantage should not be underestimated. This is because when a patient needs to vomit, it becomes very difficult for the patient to vomit if the stimulation of the cardia cannot be immediately stopped.

Advantageously, the extracorporeal control unit can load data into the intracorporeal control unit according to a loading mode authorized only by the physician. When the stimulation device is specially controlled by power, electric pulse frequency, etc., the external control unit can control the internal control unit according to the doctor mode authorized only by the doctor. For simple control of the stimulation device, such as "on" and "off", the external control unit controls the internal control unit according to the patient mode allowed for the patient. Therefore, the use of an extracorporeal control unit according to multiple modes allows the patient to control certain functions of the stimulator device and other higher functions to be controlled by the doctor, thus treating the patient after surgery. Can be flexible.

The control device may be adapted to control the source of energy to release energy intermittently, for example in the form of a series of energy pulses, for direct usage in relation to the power of the stimulation device. According to a suitable embodiment of the invention, the control device controls the source of energy to release electrical energy, and the apparatus comprises an implantable capacitor for producing a series of energy pulses from the released energy. Further has. In this case, the term "direct" means, on the one hand, that the released energy is simultaneously used when released by the control device, while on the other hand the released energy is used to power the stimulation device. Means that it may be delayed some seconds, for example by an energy stabilizer, before it is used in conjunction.

In the following, further embodiments relating to the supply and control of energy will be described. All these embodiments may be used not only for the stimulation device, but for all other applicable embodiments herein.

According to one embodiment of the invention, the device comprises an implantable electrical component including at least one or a single voltage level guard, and a capacitor or accumulator, wherein the capacitor is a capacitor. Or the charging and discharging of the accumulator is controlled by using the voltage level guard.

In one embodiment, the energy source is external to the patient's body and the control device controls the energy source to release the wireless energy. An energy storage device, preferably an electric accumulator, may be implanted in the patient to store the wireless energy released from the energy source outside the body. The electric accumulator may have at least one capacitor or at least one rechargeable battery, or at least one capacitor and at least one rechargeable combination. Alternatively, in addition to providing wireless energy, batteries may be implanted in the patient to provide electrical energy to the implanted electrical energy consuming elements of the device. If the control device has an implantable control unit, its electronics and stimulation device are directly powered by the converted wireless energy or by energy from either the implanted energy storage device or the battery. Good.

In one embodiment, wireless energy is used directly to power the stimulation device. That is, the stimulation device is powered when the wireless energy is released from the extracorporeal energy source by the control device. In this case, the term "directly" means, on the one hand, that the stimulation device is instantly powered by using the released energy without storing it, while on the other hand the released energy is It means that it may be delayed somewhat by seconds, for example by an energy stabilizer, before it is used for powering a stimulation device. In either case, the wireless energy can either be delivered by the wireless field acting directly on the device, or directly when the wireless energy is transmitted or indirectly after the accumulator has been charged. It can be used to generate direct kinetic energy by using an energy conversion device to convert energy into electrical energy that can be used to power any energy consuming part of the device. As a result, the stimulation device can be controlled very easily, with only a few implanted components of the device. For example, there is no implanted energy source, such as a battery, nor is there any implanted complex signal control system. This has the advantage that the device is very reliable.

In one embodiment, the source of energy comprises an implantable internal energy source. In that case, the control device controls the internal energy source to release energy from outside the patient's body when the internal energy source is implanted in the patient. This solution is advantageous for sophisticated embodiments of relatively energy-consuming devices, which cannot be met by direct supply of wireless energy alone. The internal energy source preferably comprises an energy source such as an accumulator or a battery. Alternatively, the control device may be adapted to release wireless energy from the internal body energy source, and further the stimulation device may be used to stimulate the cardia sphincter of the patient with the released wireless energy. It may be adapted to control. Wireless energy may include radiant energy or acoustic energy such as ultrasonic energy.

In one embodiment of the invention, the apparatus comprises a switch implanted in the patient for directly or indirectly switching the power of the stimulation device and for supplying electrical energy for powering the stimulation device. , An internal energy source, such as a battery, that is implanted in the patient, where the switch directly or indirectly affects the supply of electrical energy from the internal energy source. This solution is advantageous for those embodiments of the device which consume a relatively large amount of energy, which cannot be met by the direct supply of wireless energy alone.

In one embodiment of the invention, the switch toggles between an "off" mode in which the internal energy source is not used and an "on" mode in which the internal energy source supplies electrical energy to power the stimulation device. In this case, this switch is conveniently operated by wireless energy released from an extracorporeal energy source to switch between "on" and "off" modes. A control device, preferably having a wireless remote control, can control an external energy source to release wireless energy. An advantage of this embodiment is that the source of the implanted energy does not provide energy when the switch is in the off mode, which can significantly extend the life of the implanted energy source, such as a battery.

In one embodiment, the control device comprises a wireless remote control device for controlling the internal energy source. In this case, the switch is in an "off" mode in which the internal energy source and the remote controller are not used, and the remote controller can control the internal energy source to provide electrical energy to power the stimulation device." It can be operated by wireless energy from an external energy source to switch between "standby" modes.

In one embodiment, an apparatus includes an energy conversion device implanted in a patient for converting wireless energy into storable energy and an implantable energy storage device for storing storable energy. In addition, here the switch is implanted to switch between an “off” mode in which the internal body power of energy is not used and an “on” mode in which the internal body power supply supplies electrical energy to power the stimulation device. It can be operated by energy from an energy storage device. In this case, the control device preferably comprises a wireless remote control device for controlling the energy storage device for operating the switch.

An extracorporeal data communicator may be provided external to the patient's body, and an internal data communicator implanted in the patient to communicate with the extracorporeal data communicator may be provided. The intracorporeal data communicator can send data associated with the patient or associated with the stimulation device back to the extracorporeal data communicator. Alternatively or in combination, the external data communicator can send data to the internal data communicator. The internal data communicator is preferably capable of sending data related to at least one physical signal of the patient.

Suitably, an implantable stabilizer such as a capacitor or rechargeable accumulator may be provided to stabilize the electrical energy released by the control device. Also, the control device may control the source of energy to release energy for a predetermined amount of time or a predetermined number of energy pulses.

All of the above embodiments are preferably remotely controlled. Thus, the control device advantageously comprises a wireless remote control device for transmitting at least one wireless control signal for controlling the stimulation device. The use of this remote control device allows the function of the device to be routinely adapted to the needs of the patient, which is beneficial for the treatment of the patient.

The wireless remote control may be able to obtain information about the state of the stimulation device and control the stimulation device in response to that information. The remote control may also be capable of sending information related to the stimulation device from inside the body of the patient to the outside.

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

The remote control device can transmit a carrier signal to carry the control signal, where the carrier signal is a frequency, amplitude, or modulated frequency and amplitude, digital, analog, or digital and It is analog. Also, the control signal used in the carrier signal may be frequency, amplitude, or modulated frequency and amplitude.

Examples of the control signal include a sound wave signal such as an ultrasonic wave signal, an infrared signal, a visible light signal, an ultraviolet light signal, a laser signal, a microwave signal, a radio wave signal, an electromagnetic wave signal such as an X-ray emission signal, or a gamma emission signal. Wave signals may be included. Where applicable, more than one of the above signals may be combined.

The control signal may be digital or analog and may have an electric or magnetic field. Suitably, the wireless remote control device is capable of transmitting an electromagnetic carrier signal for carrying digital or analog control signals. For example, secure communication is achieved by using an analog carrier signal that carries a digital control signal. The control signal may be transmitted in the form of pulses by the wireless remote control.

The control device may be operated manually or non-manually to control the source of energy to release the energy.

In the embodiment of the invention shown above, the energy released may include electrical energy, and the implantable capacitor having a capacitance of less than 0.1 μF to produce the series of energy pulses described above. You may be prepared.

Wireless energy typically includes a signal.

The device may further comprise an implantable energy conversion device for converting wireless energy, eg in the form of sound waves, directly or indirectly into electrical energy for the power of the stimulation device. More specifically, the energy conversion device can have a capacitor adapted to generate electrical pulses from the converted electrical energy.

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

The stimulation device may include a band applied around the cardia, the band having a conductor that contacts the cardia sphincter. The conductor can have a hook for fixing the conductor to the cardia. The invention also provides an implantable stimulation device adapted to stimulate the cardia sphincter of a patient to enhance sphincter tonus, and a mode of operation in which the cardia sphincter is stimulated by energy pulses and the cardia sphincter. A system for treating heartburn and reflux disease having a control device for controlling the stimulation device to continuously alternate between an unstimulated rest mode. The energy pulse may include an electrical pulse. The stimulation device may have an electrical conductor engaged with the cardiac sphincter and the energy source may be adapted to pass an electrical current through the electrical conductor to generate electrical pulses. Advantageously, the control device may control the energy source to release electrical energy so that the current through the conductor reaches a predetermined value.

All of the various components described above may be combined in alternative embodiments, where applicable. Also, the various features described in connection with the above-described embodiments of the present invention may be used in other applications, where applicable.

All of the various techniques for transmitting energy and controlling energy presented herein may be implemented using all of the various components and solutions described.

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

Therefore, according to the first alternative method,
Implanting the stimulation device in the patient to engage the stimulation device with the cardia,
To continually alternate between a mode of operation in which the cardiac sphincter is stimulated by an energy pulse to strengthen the sphincter's tonus and close the cardia completely, and a rest mode in which the cardiac sphincter is not stimulated, Controlling the stimulation device is provided for treating heartburn and reflux disease.

The first alternative method can also be performed laparoscopically. Therefore,
Implanting the stimulation device in the patient using the laparoscope to engage the stimulation device with the cardia,
To continually alternate between a mode of operation in which the cardiac sphincter is stimulated by an energy pulse to strengthen the sphincter's tonus and close the cardia completely, and a rest mode in which the cardiac sphincter is not stimulated, A laparoscopic method for treating heartburn and reflux disease can be provided, including controlling a stimulation device.

According to the second alternative method,
(A) surgically implanting an electrical stimulation device engaged to the cardia into the patient;
(B) providing a source of energy outside the patient's body,
(C) using the released wireless energy in connection with controlling the extracorporeal energy source from outside the patient's body to release the wireless energy; and (d) powering the stimulation device. A method for treating a patient suffering from heartburn and reflux disease is provided.

A second alternative method includes implanting an energy conversion device, controlling an extracorporeal energy source to release wireless energy, and energy for use in connection with the power of the stimulation device. Converting the wireless energy into an energy different from the wireless energy by the conversion device. The method may further include implanting a stabilizer into the patient to stabilize the energy converted by the energy conversion device.

further,
Implanting a stimulation device into the patient to engage the cardiac sphincter;
Providing a control device for controlling the stimulation device to stimulate the cardiac sphincter to strengthen the sphincter's tonus so that the cardia is completely closed;
Enabling the patient to manipulate the control device to change the intensity of the stimulus, a method for treating heartburn and reflux disease is provided.

In one embodiment, a pulse of energy creates a stimulus to the cardia sphincter to strengthen the sphincter's tonus to completely close the cardia, and further to cause the control device to be operable by the patient and thus stopped. An apparatus is provided, such that it can be configured, wherein the control device is further operable by the patient to set the stimulator device in an operative state, in which the stimulator device has the cardia sphincter above. The mode of operation stimulated by the energy pulse and the rest mode in which the cardia sphincter is not stimulated are continuously switched, wherein the device is at least for sensing at least one physical parameter of the patient. Further comprising one implantable sensor, wherein the control device is adapted to control the stimulation device to stop the continuous alternation between the operating mode and the dormant mode and further to the patient. It is adapted to set the stimulation device in a dormant mode in response to a sensor that senses a physical parameter.

In one embodiment, a pulse of energy creates a stimulus to the cardiac sphincter to strengthen the sphincter's tonus so that the cardia is completely closed, and further such that the control device is operable by the patient and thus stops. Apparatus is provided, wherein the control device is further operable by the patient to set the stimulator device in an operative state, wherein the stimulator device is configured such that the cardiac sphincter is Continuously alternate between modes of motion stimulated by the energy pulse of the heart and rest modes in which the cardia sphincter is not stimulated, where the device causes at least the contraction wave of the esophagus caused by the patient swallowing food Further comprising at least one implantable sensor for sensing as a physical parameter of the patient, wherein the control device stops continuous alternation between the operating mode and the dormant mode. The device is adapted to control the stimulation device and further to set the stimulation device in a dormant mode in response to a sensor sensing a contraction wave of the patient's esophagus.

(Surface structure)
Next, the surface structure of various implants of the present invention will be described.

The present invention relates to an implant adapted to be adjustable post-operatively and having at least one expandable section, the implant being adjustable between a first collapsed state and a second expanded state. Is adapted to. In the first folded state, the expandable section is folded, and in the second expanded state, the expandable section is expanded. The outer surface of the expandable section at least partially includes a surface structure having high areas alternating with low areas. The expandable section is configured such that, in at least one of the first folded state and the second expanded state, adjacent high regions are adjacent to each other in the first folded state and the second folded state of the implant due to growth of fibrous tissue. Adapted to have a first distance between adjacent high areas that is sufficiently expanded to prevent direct interconnection to the extent that adjustability to and from the expanded state of .. The expandable section further having a connection region between the adjacent high region and low region has an adjacent connection due to growth of fibrous tissue in at least one of the first folded state and the second expanded state. Adjacent, sufficiently expanded, to prevent regions from being directly interconnected to the extent that the adjustability between the first collapsed state and the second expanded state of the implant is compromised. It is further adapted to have a second distance between the connection areas.

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

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

Since fibrous tissue often has a stretch or thickness of about 0.5 mm to about 1.5 mm, the distance between the corresponding surfaces of the surface structure elements is preferably about 3 mm or about 2×1. Greater than 5 mm. However, depending on the surroundings, a distance of about 1.0 mm to more than about 3 mm may be sufficient. If the fibrous tissue is expected to have a stretch or thickness greater than about 1.5 mm, the distance between the corresponding surfaces of the surface structure elements is appropriately adapted.

The surface structure may have high and low areas, and the distance between the different planes of the high and low areas should also be above a certain threshold to assist the implant in its ability to fold and expand. May be appropriate. If the distance is too small, the implant's ability to collapse and expand may be limited. Suitable intervals for the above distances are about 0.5 mm to 10 mm, more preferably about 2 mm to 8 mm, most preferably about 3 mm to 7 mm. The surface structure may include a plurality of geometric elements or shapes and any combination of those elements or shapes, as long as the above distance conditions are met. The surface structure can include, for example, differently shaped ridges and grooves. The ridges and grooves can each have a cross-section, for example wedge-shaped, polygonal, square, pyramidal or truncated pyramidal. Further, the ridges and grooves may have different cross-sectional shapes. The surface structure may generally have a bellows-shaped configuration or a surface structure in which geometric objects of the same or different kind(s) are arranged on the surface. The geometrical objects may be arranged on the surface in a substantially random manner or according to some scheme.

One type of implant that may be considered suitable is an implant that has the ability to substantially change shape and/or size. Therefore, this is the case when the presence of fibrous tissue can substantially impede or inhibit the function of the implant. However, this surface structure may be used for any implant if the properties of the surface structure are beneficial to the implant.

(Combination with obesity treatment)
These various embodiments may be combined with various methods of treating obesity. In particular, two embodiments are described below, one containing an expansion device and the other containing a volume filling device.

(Expansion device for obesity treatment)
Note that where applicable, all embodiments or portions of embodiments or methods may be used for all of the different embodiments herein. Also, the various embodiments of the apparatus for treating reflux can be combined in a device for the treatment of obesity based on the fact that it can create a feeling of fullness by creating the action of spreading the stomach wall. Providing a device with an expansion device for expanding a portion of the stomach wall results in a simpler, safer, and long-acting device.

The expression "power supply" is to be understood as being energized by all but manual power, preferably by electrical energy. In other words, the adjusting device is operated non-manually. The expression "non-manual" does not mean that the adjusting device is actuated by manually touching the subcutaneously implanted component of the device and further by touching the patient's skin. Be understood to mean. Thus, unlike conventional approaches when treating anal incontinence, the conditioning device of the present invention operates by manual force, such as manually squeezing a fluid-containing balloon that is implanted in the scrotum or in the region of the labia majora. Not done. Of course, in addition to manually operating the start button under the skin to activate a powered operation device, manually operating the implanted reservoir or another mechanical or fluid Pressure solutions may also be used and everything is possible within the scope of the invention.

Alternatively or preferably, in combination with a powered operating device, eg a gear box for reducing speed to increase force or torque, eg a servo capable of rotating a motor at high speed with weak force Means may be used. The servo means may include hydraulic means, electric control means, magnetic means or mechanical means which may be actuated by a manual operating means and/or a remote control device. By using a servo system, the use of force can be reduced when adjusting the adjusting device, which can be important in many applications.

The term "servo means" includes the usual definition of a servomechanism, ie an automatic device that controls a large amount of power with a very small amount of power, but as an alternative or in addition, a long stroke operating element. It may include the definition of a booster mechanism that transmits a weak force acting on the moving element as a strong force acting on another operation element having a short stroke. The servo means may include a motor, preferably an electric motor that is reversible.

Alternatively or preferably in combination with manual operation, for example, the patient's hand may operate the hydraulic reservoir with high force, for example, to move a small amount of fluid with high force to control large movements of the fluid. Reverse burst servo means may be used, as may be possible. The reburst servo means may include hydraulic means, electrical control means, magnetic means or mechanical means, which may be actuated by manually operated means and/or by remote control. By using a reburst servo system, stroke usage can be reduced when adjusting the adjustment device, which can be important in many applications.

The term "reburst servo means" is a definition of a device that is controlled by a strong force and a small stroke, ie, moving a small amount of fluid with a large force and controlling the movement of a large amount of fluid with a very weak force. Alternatively, or additionally, includes the definition of a reverse boost mechanism that transmits a strong force acting on a short stroke motion element as a weak force acting on another long stroke motion element. You may. Reburst servo means are preferably used when manual device control is possible through intact skin.

In general, the two locations on the stomach wall must be moved relative to each other so that a small portion of the stomach wall can be expanded to provide a feeling of fullness. This can be done in many different ways. One approach is to expand the invagination device that is invaginated in the stomach wall. Another approach is to move two fixed positions on the stomach wall. Of course, the first and second positions may be sutured or secured to the stomach wall in many possible ways and the present invention allows the two parts of the stomach wall to be moved away from each other thereby causing at least two positions on the stomach wall. In, all possibilities of expanding the stomach wall by moving the first fixed position of the device relative to the second fixed position are included. However, it is preferred that the device is loosely suspendedly connected to the stomach wall by invagination of at least one adapted portion of the device, where the fibrotic stomach to stomach tissue. This promotes the acquisition of a stable position in the long term.

Any type of mechanical configuration may be used. Any mechanical configuration that is mechanically or hydraulically driven, or any pneumatic configuration may be used. To achieve the simple task of widening a part of the stomach wall by moving at least two parts of the stomach wall away from each other, any motor, any pump, or a movable material that changes its shape when powered May be used.

Any type of hydraulic operation may be employed. It should be appreciated that pneumatic operation may be used instead of hydraulic operation. In this case, instead of hydraulic fluid, air is moved between the reservoir and the chamber formed by the expansion device. Suitably, the reservoir has a fixed position for maintaining the reservoir in the desired position when operated by the patient. When squeezed, the reservoir preferably remains squeezed and is released by being pressed again.

Any type of hydraulic strategy for expansion devices may be used. The hydraulic solution may be mechanically or manually driven by being powered by any motor or pump.

Of course, simply expanding the invaginated portion of the stomach will cause the stomach wall to spread apart, again powered mechanically, hydraulically, pneumatically, or using a motor or pump. May be achieved by receiving or by manual force.

(Volume filling device for obesity treatment)
In addition, various embodiments of the apparatus for treating regurgitation additionally relieve obesity based on the ability of the distal portion of the elongated, movement-limiting device in the stomach to provide a feeling of satiety to fill the volume. Can be adapted to treat. In the present context, reference is made to the distal portion of the elongated movement restriction device when the volume filling device and its features, functions and suitability are considered. It should be noted that any of the features, embodiments, embodiments or methods described herein may be used for both the distal or proximal portions of the movement restriction device, where applicable. ..

The following embodiments show that the inflatable body is protected from gastric acid by invading the stomach wall of the patient with a volume filling device (shown here as the distal portion of the movement restriction device) and thus for a very long period of time. It is based on the fact that functions can be maintained.

According to one embodiment of the invention, there is provided a device for treating obesity and reflux in a patient having a stomach with a food cavity, the device being at least substantially recessed in a gastric wall portion of the patient. Having at least one volume filling device adapted to be placed therein, wherein the volume filling device is adapted to be located outside the stomach wall, whereby the size of the volume of the hood cavity is Reduced by a volume that substantially exceeds the volume of the volume-filling device, where the surface of the volume-filling device comprises a biocompatible material, where a substantial portion of the surface of the volume-filling device faces the exterior of the stomach wall. And is adapted to rest, wherein the volume filling device has a maximum perimeter of at least 30 mm.

By invading the volume filling device into the stomach wall portion of the patient outside the stomach wall, the volume filling device becomes protected from gastric acid, resulting in a long lasting device.

The volume filling device is adapted to be placed with its outer surface stationary facing the stomach wall, whereby the volume size of the hood cavity is reduced by a volume substantially exceeding the volume of the volume filling device. To be done. The volume filling device has a maximum perimeter of at least 30 millimeters. Thus, the device of the present invention is well suited to treat obesity in patients with reflux disease as well as obesity. This is advantageous as reflux disease is a very common condition among people suffering from obesity.

According to a first option, the volume filling device is adapted to be placed inside the stomach with the outer surface of the volume filling device stationary facing the inside of the stomach wall.

According to a second option, the volume filling device is adapted to be placed outside the stomach with the outer surface of the volume filling device stationary facing the outside of the stomach wall.

Suitably, the volume filling device is adapted to be completely invaginated by the patient's stomach wall and to be positioned inside or outside the stomach wall via a gastroscopy instrument. For this purpose, the volume filling device may have a fitting device adapted to cooperate with the gripping device. Suitably, the volume filling device is adapted such that it can be adjusted non-invasively after surgery.

The device may have one fixation device adapted to participate in fixing the volume filling device to the stomach wall, preferably two or more fixation devices. The volume filling device may have one holding device, preferably two or more holding devices adapted to be held by the instrument, in order to simplify implantation of the device.

At least a portion of the volume filling device may be made of a material that is not degraded by gastric acid. The volume filling device may be decomposable by an acid such as hydrochloric acid.

In one embodiment, the volume filling device is expandable to an expanded state and has an enclosure defining a chamber, the volume filling device being expanded by a gel or fluid provided within the chamber. At least one tube may be connected to the volume filling device for supplying gel or fluid to the chamber. An injection port connectable to the tubing may be provided. Alternatively, the volume filling member may be provided with an inlet port for a fluid or gel connectable to the gastroscopy instrument, wherein the inlet port interconnects the expandable device and the gastroscopy instrument. With a fluid connection adapted to.

The volume filling device may include a homogeneous material such as a gel having a shure value of less than 15. This device may also be a solid body.

The volume filling device may have a rigid, elastic or flexible outer surface. When the outer surface is rigid, the outer surface has such a high rigidity that it remains undeformed when subjected to the force generated by the movement of the stomach. The volume filling device may include a flexible inelastic material.

According to a first schematic design of a volume filling device, this device has a maximum perimeter found in a plane perpendicular to the axis through the device. The perimeter of the device is equal to the maximum perimeter, as seen in another plane that is perpendicular to the axis, or decreases, as seen in a direction starting from the maximum perimeter along the axis. For example, the device may be substantially oval, spherical, or substantially ovoid with a concave central section or curved oval.

According to a second schematic design of this device, does the perimeter of the device seen in a plane perpendicular to the axis through the device increase or decrease at least twice as the plane is displaced along said axis? , Decrease and increase at least once as the plane is displaced along said axis. For example, the device may be substantially kidney-like shaped.

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

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

Volume filling device, 0.0001 m ³ from 0.001 m ^3, or, 0.001 m ³ from 0.00001M ^3, or have a volume in the range from 0.00001M ³ of 0.0002 m ^3. The volume of the volume filling device is less than 0.0002 m ³ .

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

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

Suitably, the volume filling device comprises a coating. For example, parylene coating, polytetrafluoroethylene coating or polyurethane coating. These coatings may be multilayer coatings. The volume filling device may have an outer surface layer of polyurethane, Teflon® or PTFE, or a combination thereof.

The volume filling device may include a fluid adapted to be transformed into a solid or fixed form. The fluid may be liquid polyurethane, i.e. isotonic. The fluid may contain macromolecules such as iodine molecules to prevent diffusion.

The volume filling device may have a maximum perimeter of at least 50 millimeters, preferably at least 80 millimeters. Preferably, the volume filling device is deformable to a maximum diameter so that it can be inserted into a laparoscopic trocar.

Suitably, the volume filling device is adapted to be held in place by a gastro-gastric suture or staple for invagination of the device into the stomach wall. Advantageously, the volume-filling device has a perimeter that varies to better maintain it in place when it is invaginated in the stomach wall of a patient. Stomach-A stomach-suture or staple is formed with a structure adapted to contact the stomach wall for promoting in-growth of human tissue and for long-term fixation of the position of a volume filling device attached to the stomach wall. A fixed part may be provided. The structure may include a net-like structure.

In an embodiment of the invention, the apparatus further comprises an expansion device located outside the stomach wall, adapted to widen a portion of the stomach wall to affect the patient's appetite. If the volume filling device is inflatable, the apparatus may have a fluid connection that interconnects the expansion device and the volume filling device.

(Overview)
In one embodiment, an apparatus includes an expansion device including at least one steerable expansion device implantable in an obese patient adapted to spread a portion of the stomach wall of the patient, and the gastric wall when implanted. And an operating device for operating the expansion device so as to widen the portion and thereby give a feeling of fullness.

In one embodiment, the apparatus includes at least one steerable expansion device implantable in the patient adapted to spread a portion of the patient's stomach wall and a patient's patient when implanted with the expansion device. And an implantable control unit for automatically controlling the steerable expansion device to open the gastric wall portion associated with eating to provide a feeling of fullness.

In one embodiment, the apparatus has an expansion device including at least one operable expansion device implantable in an obese patient adapted to widen a portion of a patient's stomach wall, wherein said expansion is performed. The device has an expandable expansion reservoir and a manipulating device for manipulating the expansion device to open the stomach wall portion when implanted, wherein at least the distal portion of the movement restriction device is inflatable. And is fluidly connected to the dilation reservoir, wherein the manipulating device for squeezing fluid between the main reservoir and the dilation reservoir expands the gastric wall portion to provide satisfaction. Have a pump. A control device may be provided to control the expansion device, including the pump. The control device may have a wireless remote control adapted to control the expansion device from outside the patient's body or an implantable control unit for controlling the expansion device. Alternatively, the control device may have a switch placed subcutaneously or a reservoir adapted to control the expansion device from outside the patient's body. A sensor or sensing device may be provided that is implanted within the patient's body, wherein the implantable control unit is adapted to directly or indirectly sense that the patient has taken in food. Adapted to control the expansion device from within the patient's body using information from the device.

In one embodiment, the distal portion of the movement restriction device comprises a main volume filling reservoir and at least one manipulable expansion device implantable in an obese patient adapted to spread a portion of the patient's stomach wall. And an expansion device that includes an expansion device, wherein the expansion device is adapted to be invaginated in the stomach wall at an upper portion of the stomach that is higher than the inflatable main volume filling device when the patient is standing. Having an adapted inflatable reservoir, wherein the volume filling device is inflatable and is fluidly connected to the expansion reservoir, wherein the gastric wall is normally associated with food intake. The contraction causes fluid to flow out of the invaginated main volume filling reservoir located at the bottom of the stomach wall adapted to cause the expansion reservoir to widen the stomach wall portion to provide a feeling of fullness. The fluidic connection between the main volume filling reservoir and the expansion reservoir has a check valve. The fluid connection between the main volume filling reservoir and the expansion reservoir has a release function adapted to release the volume of the expansion reservoir for return to the main volume filling reservoir. The release function allows the fluid to be released slowly from an expansion reservoir back to the main volume filling device reservoir to release the gastric wall portion being expanded as described above. The fluid return connection may have a substantially smaller area than the connection. There is provided another manual control device having a subcutaneously located reservoir adapted to control the dilator device from outside the patient's body to additionally act upon the dilator device to spread the gastric wall portion. You can

In one embodiment, a main volume filling reservoir adapted to be expandable may be provided, wherein the distal portion of the movement restriction device is expanded when the device is invaginated in the stomach wall. Further has an expandable structure adapted to have a bellows adapted to allow for fibrosis to occur around the device when implanted. However, the movement of the bellows makes it virtually insensitive to fibrosis.

In one embodiment, the apparatus has an expansion device including at least one steerable expansion device implantable in an obese patient adapted to spread a portion of a patient's stomach wall, where the expansion device. Has an expandable structure adapted to expand and unfold a gastric wall portion when the device is invaginated in the stomach wall, wherein the structure is the device when implanted. It has a special bellows adapted to take into account the fact that fibrosis occurs around the, and the movement of this bellow makes it substantially unaffected by said fibrosis. A manipulation device for manipulating the expansion device may be provided to spread the stomach wall portion and provide a feeling of fullness. The apparatus has an implantable control unit that automatically controls the operable dilatation device to expand the gastric wall portion associated with the patient's feeding and provide a feeling of satiety when implanted with the dilation device. You can

In one embodiment, the apparatus has an expansion device including at least one operable expansion device implantable in an obese patient, adapted to open a portion of the patient's stomach wall to provide a feeling of satiety. The control device may have a wireless remote control adapted to control the expansion device from outside the patient's body or an implantable control unit for controlling the expansion device. Alternatively, the control device may have a switch placed subcutaneously or a reservoir adapted to control the expansion device from outside the patient's body. A sensor or sensing device adapted to be implanted within the patient's body may be provided, and an implantable control unit adapted to directly or indirectly sense that the patient has taken in food. And adapted to control the dilation device from within the patient's body using information from the sensor or sensing device.

In one embodiment, the device is adapted to treat reflux disease. For this purpose, the apparatus further comprises an implantable movement restriction device having an elongated shape having a proximal portion and a distal portion, the proximal portion being at least partially invaginated by the wall of the gastric fundus of the patient. And having an outer surface that comprises a biocompatible material. A substantial portion of the outer surface of the proximal portion of the movement restriction device does not injure the stomach wall at some location between the patient's diaphragm and at least a portion of the lower portion of the invaginated basal wall. Is adapted to rest against the gastric wall so that the cardia notch of the patient's stomach moves toward the patient's diaphragm when the proximal portion of the movement restriction device is invaginated. To prevent the cardia from sliding through the patient's diaphragm, which is open into the patient's thorax, and to maintain support pressure on the patient's cardia sphincter extending from the patient's abdomen. It The proximal portion of the movement restriction device has a size of at least 125 mm ³ and a perimeter of at least 15 mm. The distal portion stabilizes and holds the proximal portion and is adapted to be substantially invaginated in the stomach wall.

In another embodiment, the device is adapted to treat reflux disease. To this end, the apparatus further comprises an elongated shaped implantable movement restriction device having a proximal portion and a distal portion and further having an outer surface comprising a biocompatible material. The proximal portion of the movement restriction device is adapted to rest with at least a portion of its outer surface facing the gastric basal wall at a location between the patient's diaphragm and the gastric basal wall. As a result, the movement restriction device limits the movement of the cardia notch in the patient's stomach toward the patient's diaphragm when implanted in the patient, which causes the cardia to enter the patient's thorax. It is prevented from sliding through the diaphragm of an open patient and a bearing pressure is maintained on the patient's cardia sphincter extending from the patient's abdomen, wherein the proximal portion of the movement restriction device is at least 125 mm ³ . It has a size and a perimeter of at least 15 mm. The attachment device is adapted to secure the proximal portion of the movement restriction device in the position when the movement restriction device is implanted. The distal portion stabilizes and holds the proximal portion and is adapted to be substantially invaginated in the stomach wall.

In another embodiment, the device is adapted to treat reflux disease. To this end, the apparatus further comprises an elongated shaped implantable movement restriction device having an outer surface comprising a proximal portion and a distal portion and further comprising a biocompatible material, the proximal portion comprising: It is adapted to be at least partially invaginated in the wall of the gastric fundus. A substantial portion of the outer surface of the proximal portion of the movement restriction device does not injure the stomach wall at some location between the patient's diaphragm and at least a portion of the lower portion of the invaginated basal wall. Is adapted to rest against the stomach wall, such that the cardia notch of the patient's stomach is restricted from moving toward the patient's diaphragm when the movement restriction device is invaginated, This prevents the cardia from sliding through the patient's diaphragm, which is open into the patient's thorax, maintains the supportive pressure on the patient's cardia sphincter extending from the patient's abdomen, and restricts movement. Is at least 1
At least one operable expansion device implantable in an obese patient, having a size of 25 mm ³ and a perimeter of at least 15 mm, and further adapted to open a portion of a patient's stomach wall to provide a feeling of satiety. Having an expansion device including. The distal portion stabilizes and holds the proximal portion and is adapted to be substantially invaginated within the stomach wall.

In another embodiment, the device is adapted to treat reflux disease. To this end, the apparatus further comprises an elongated shaped implantable movement restriction device having a proximal portion and a distal portion and further having an outer surface comprising a biocompatible material. The proximal portion of the movement restriction device is adapted to rest with at least a portion of its outer surface facing the gastric basal wall at a location between the patient's diaphragm and the gastric basal wall. As a result, the cardia notch of the patient's stomach is restricted from migrating toward the patient's diaphragm when the movement restriction device is implanted in the patient, which causes the cardia to enter the patient's thorax. To prevent sliding through the patient's diaphragm, which is open, and to maintain supporting pressure on the patient's cardia sphincter extending from the patient's abdomen, wherein the movement restriction device has a size of at least 125 mm ³ and It has a perimeter of at least 15 mm and further has a fixation device adapted to fix the movement restriction device in the position when the movement restriction device is implanted. The distal portion stabilizes and holds the proximal portion and is adapted to be substantially invaginated within the stomach wall. The apparatus further comprises an expansion device including at least one operable expansion device implantable in an obese patient adapted to open a portion of a patient's stomach wall to provide a feeling of satiety.

In one embodiment, the apparatus further comprises an expansion device that includes three or more mechanical portions that are each engaged to a different portion of the stomach wall, wherein the engagement includes suturing or stapling the stomach wall. Alternatively, it involves invading a mechanical portion into the stomach wall with a stomach-gastric suture, wherein three or more mechanical portions are adapted to be moved relative to each other and further three different walls. Adapted to expand the segment, the expansion device is also independent of each other, taking into account all the forces used to expand the gastric wall segment, the time at which the expansion is made, and the timing at which the expansion is made. Adapted to widen the plurality of wall portions.

In one embodiment, the apparatus further comprises an expansion device that includes two or more hydraulic portions, each of which is engaged with a different portion of the stomach wall, wherein the engagement includes placing the hydraulic portion on the stomach wall. This includes suturing or stapling or invading the hydraulic portion into the stomach wall portion with a stomach-gastric suture, wherein two or more hydraulic portions are moved relative to each other. Adapted and further adapted to unfold three different wall portions, the dilation device further comprises the force used to unfold the gastric wall portion, the time at which the dilation occurs, and the timing at which the dilation occurs. Considering all, it is adapted to spread the wall parts independently of each other.

In one embodiment, the apparatus further comprises an expansion device engaged to a portion of the stomach wall, including suturing or stapling the expansion device to the stomach wall or a gastro-gastric suture to secure the expansion device to the stomach wall portion. In which the dilation device further dilates the gastric wall portion while controlling the force used to dilate the gastric wall portion, the time at which the dilation occurs, and the timing at which the dilation occurs. Is adapted as

In one embodiment, the apparatus further comprises an expansion device including two portions, each of which is engaged with a different portion of the stomach wall, wherein the engagement involves suturing or stapling those portions to the stomach wall. Or gastro-stomach-suture to incise these parts into the wall of the stomach, where the expansion device further includes the force used to expand the wall of the stomach and the time at which the expansion occurs. , Are adapted to spread different wall parts independently of each other while controlling when expansion is performed.

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

In one embodiment, the apparatus further comprises a sensor or sensing device adapted to be implanted within the patient's body, wherein the implantable control unit directly indicates that the patient has taken food. Or adapted to control the device from within the patient's body using information from said sensor or sensing device adapted to sense indirectly.

According to another aspect of the invention, there is provided a device for treating reflux disease and obesity in an obese patient having a stomach having a hood cavity, the device comprising an implantable portion including a proximal portion and a distal portion. A movement restriction device, wherein the distal portion has an outer surface adapted to be at least substantially invaginated in the gastric wall portion of the patient and further has an outer surface comprising a biocompatible material, wherein The distal portion of the device is adapted to be placed inside the stomach with the outer surface of the volume-filling device stationary facing the inside of the stomach wall so that the volume size of the hood cavity is volume-filled. The volume is reduced by substantially more than the volume of the device. The distal portion of the movement restriction device has a maximum circumference of at least 30 millimeters.

It should be noted that any embodiment or part of the embodiment, feature or method or associated system, or part of the system described herein may be combined in any combination.

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

FIG. 3 is a schematic diagram illustrating various embodiments of a device for treating gastroesophageal reflux disease implanted in a human patient. FIG. 3 is a schematic diagram illustrating various embodiments of a device for treating gastroesophageal reflux disease implanted in a human patient. FIG. 3 is a schematic diagram illustrating various embodiments of a device for treating gastroesophageal reflux disease implanted in a human patient. FIG. 3 is a schematic diagram illustrating various embodiments of a device for treating gastroesophageal reflux disease implanted in a human patient. FIG. 3 is a schematic diagram illustrating various embodiments of a device for treating gastroesophageal reflux disease implanted in a human patient. FIG. 3 is a schematic diagram illustrating various embodiments of a device for treating gastroesophageal reflux disease implanted in a human patient. FIG. 3 is a schematic diagram illustrating various embodiments of a device for treating gastroesophageal reflux disease implanted in a human patient. 1 is a schematic diagram showing an embodiment of an apparatus for treating gastroesophageal reflux disease and obesity implanted in a human patient. 1 is a schematic diagram showing an embodiment of an apparatus for treating gastroesophageal reflux disease and obesity implanted in a human patient. 1 is a schematic diagram showing an embodiment of an apparatus for treating gastroesophageal reflux disease and obesity implanted in a human patient. 1 is a schematic diagram showing an embodiment of an apparatus for treating gastroesophageal reflux disease and obesity implanted in a human patient. 1 is a schematic diagram showing one embodiment of a device for treating gastroesophageal reflux disease implanted in a human patient. 1 is a schematic diagram showing one embodiment of a device for treating gastroesophageal reflux disease implanted in a human patient. FIG. 9 shows an alternative configuration of a migration restriction device for treating gastroesophageal reflux disease, adapted to be implanted in a human patient. FIG. 9 shows an alternative configuration of a migration restriction device for treating gastroesophageal reflux disease, adapted to be implanted in a human patient. FIG. 9 shows an alternative configuration of a migration restriction device for treating gastroesophageal reflux disease, adapted to be implanted in a human patient. FIG. 9 shows an alternative configuration of a migration restriction device for treating gastroesophageal reflux disease, adapted to be implanted in a human patient. FIG. 9 shows an alternative configuration of a migration restriction device for treating gastroesophageal reflux disease, adapted to be implanted in a human patient. FIG. 9 shows an alternative configuration of a migration restriction device for treating gastroesophageal reflux disease, adapted to be implanted in a human patient. FIG. 9 shows an alternative configuration of a migration restriction device for treating gastroesophageal reflux disease, adapted to be implanted in a human patient. 1 is a general view showing a patient having an implanted migration restriction device for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various techniques for powering a device for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various techniques for powering a device for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various techniques for powering a device for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various techniques for powering a device for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various techniques for powering a device for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various techniques for powering a device for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various techniques for powering a device for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various techniques for powering a device for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various techniques for powering a device for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various techniques for powering a device for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various techniques for powering a device for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various techniques for powering a device for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various techniques for powering a device for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various techniques for powering a device for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various techniques for powering a device for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various techniques for powering a device for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various techniques for powering a device for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various approaches to constructing hydraulic or pneumatic power supply to the device of the present invention for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various approaches to constructing hydraulic or pneumatic power supply to the device of the present invention for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various approaches to constructing hydraulic or pneumatic power supply to the device of the present invention for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various approaches to constructing hydraulic or pneumatic power supply to the device of the present invention for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various approaches to constructing hydraulic or pneumatic power supply to the device of the present invention for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various approaches to constructing hydraulic or pneumatic power supply to the device of the present invention for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various approaches to constructing hydraulic or pneumatic power supply to the device of the present invention for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various approaches to constructing hydraulic or pneumatic power supply to the device of the present invention for treating gastroesophageal reflux disease. FIG. 4 is a schematic diagram showing various approaches to constructing hydraulic or pneumatic power supply to the device of the present invention for treating gastroesophageal reflux disease. FIG. 4 is a schematic diagram showing various approaches to constructing hydraulic or pneumatic power supply to the device of the present invention for treating gastroesophageal reflux disease. FIG. 6 is a schematic diagram showing various approaches to constructing hydraulic or pneumatic power supply to the device of the present invention for treating gastroesophageal reflux disease. 7 is a flow chart showing steps performed when implanting a migration restriction device for treating gastroesophageal reflux disease. FIG. 6 shows a method for repairing the cardia and basal position of a patient with gastroesophageal reflux disease. FIG. 6 shows a method for repairing the cardia and basal position of a patient with gastroesophageal reflux disease. FIG. 6 shows a method for repairing the cardia and basal position of a patient with gastroesophageal reflux disease. FIG. 6 shows a method for repairing the cardia and basal position of a patient with gastroesophageal reflux disease. FIG. 6 shows a method for repairing the cardia and basal position of a patient with gastroesophageal reflux disease. FIG. 6 shows a method for repairing the cardia and basal position of a patient with gastroesophageal reflux disease. FIG. 6 shows a plurality of shapes and features of a reflux treatment device included in the device according to the invention. FIG. 6 shows a plurality of shapes and features of a reflux treatment device included in the device according to the invention. FIG. 6 shows a plurality of shapes and features of a reflux treatment device included in the device according to the invention. FIG. 6 shows a plurality of shapes and features of a reflux treatment device included in the device according to the invention. FIG. 6 shows a plurality of shapes and features of a reflux treatment device included in the device according to the invention. FIG. 5 shows a retractable implantable reflux treatment device included in the device according to the invention and an instrument for positioning the reflux treatment device outside the stomach wall of a patient. FIG. 5 shows a retractable implantable reflux treatment device included in the device according to the invention and an instrument for positioning the reflux treatment device outside the stomach wall of a patient. FIG. 5 shows a retractable implantable reflux treatment device included in the device according to the invention and an instrument for positioning the reflux treatment device outside the stomach wall of a patient. FIG. 5 shows a retractable implantable reflux treatment device included in the device according to the invention and an instrument for positioning the reflux treatment device outside the stomach wall of a patient. FIG. 48 shows different steps of invagination of the expandable device of FIG. 47a outside the stomach wall of a patient. FIG. 48 shows different steps of invagination of the expandable device of FIG. 47a outside the stomach wall of a patient. FIG. 48 shows different steps of invagination of the expandable device of FIG. 47a outside the stomach wall of a patient. FIG. 48 shows different steps of invagination of the expandable device of FIG. 47a outside the stomach wall of a patient. FIG. 48 shows different steps of invagination of the expandable device of FIG. 47a outside the stomach wall of a patient. FIG. 48 shows different steps of invagination of the expandable device of FIG. 47a outside the stomach wall of a patient. FIG. 48 shows different steps of invagination of the expandable device of FIG. 47a outside the stomach wall of a patient. FIG. 48 shows different steps of invagination of the expandable device of FIG. 47a outside the stomach wall of a patient. FIG. 48 shows different steps of invagination of the expandable device of FIG. 47a outside the stomach wall of a patient. FIG. 3 is a diagram showing an embodiment in which a reflux treatment device is applicable to treatment of obesity. FIG. 3 is a diagram showing an embodiment in which a reflux treatment device is applicable to treatment of obesity. FIG. 3 is a diagram showing an embodiment in which a reflux treatment device is applicable to treatment of obesity. FIG. 3 is a diagram showing an embodiment in which a reflux treatment device is applicable to treatment of obesity. FIG. 3 is a diagram showing an embodiment in which a reflux treatment device is applicable to treatment of obesity. FIG. 3 is a diagram showing an embodiment in which a reflux treatment device is applicable to treatment of obesity. FIG. 3 is a diagram showing an embodiment in which a reflux treatment device is applicable to treatment of obesity. FIG. 3 is a diagram showing an embodiment in which a reflux treatment device is applicable to treatment of obesity. FIG. 3 is a diagram showing an embodiment in which a reflux treatment device is applicable to treatment of obesity. FIG. 3 is a diagram showing an embodiment in which a reflux treatment device is applicable to treatment of obesity. FIG. 3 is a diagram showing an embodiment in which a reflux treatment device is applicable to treatment of obesity. FIG. 3 is a diagram showing an embodiment in which a reflux treatment device is applicable to treatment of obesity. FIG. 3 is a diagram showing an embodiment in which a reflux treatment device is applicable to treatment of obesity. FIG. 3 is a diagram showing an embodiment in which a reflux treatment device is applicable to treatment of obesity. FIG. 48 shows the different steps of invading the expandable device of FIG. 47a inside the stomach wall of a patient. FIG. 48 shows the different steps of invading the expandable device of FIG. 47a inside the stomach wall of a patient. FIG. 48 shows the different steps of invading the expandable device of FIG. 47a inside the stomach wall of a patient. FIG. 48 shows the different steps of invading the expandable device of FIG. 47a inside the stomach wall of a patient. FIG. 48 shows the different steps of invading the expandable device of FIG. 47a inside the stomach wall of a patient. FIG. 48 shows the different steps of invading the expandable device of FIG. 47a inside the stomach wall of a patient. FIG. 48 shows the different steps of invading the expandable device of FIG. 47a inside the stomach wall of a patient. FIG. 48 shows the different steps of invading the expandable device of FIG. 47a inside the stomach wall of a patient. It is a figure which shows the apparatus for implement|achieving invagination to the wall of the stomach. It is a figure which shows the apparatus for implement|achieving invagination to the wall of the stomach. It is a figure which shows the apparatus for implement|achieving invagination to the wall of the stomach. It is a figure which shows the laparotomy technique for treating reflux disease. It is a figure which shows the laparotomy technique for treating reflux disease. 1 is a schematic block diagram illustrating one embodiment of the reflux disease apparatus of the present invention, where the wireless energy used to power the stimulation device is released from an extracorporeal energy source. FIG. 6 is a schematic block diagram illustrating another embodiment of the present invention, where wireless energy is released from an internal energy source. FIG. 6 is a schematic block diagram illustrating each of four embodiments of the present invention, wherein a switch for directly or indirectly switching the power of a stimulation device is implanted in a patient. FIG. 6 is a schematic block diagram of each of four embodiments of the present invention, wherein a switch for directly or indirectly switching the power of the stimulation device is implanted in the patient. FIG. 6 is a schematic block diagram of each of four embodiments of the present invention, wherein a switch for directly or indirectly switching the power of the stimulation device is implanted in the patient. FIG. 6 is a schematic block diagram illustrating each of four embodiments of the present invention, wherein a switch for directly or indirectly switching the power of a stimulation device is implanted in a patient. FIG. 3 is a schematic block diagram showing possible combinations of implantable components for implementing various communication options. FIG. 5 shows a device according to the invention implanted in a patient. FIG. 3 is a block diagram illustrating remote control device elements of one embodiment of the present invention. FIG. 6 illustrates an embodiment of a device for treating obesity by expanding the wall of the stomach that may be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates an embodiment of a device for treating obesity by expanding the wall of the stomach that may be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates an embodiment of a device for treating obesity by expanding the wall of the stomach that may be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates an embodiment of a device for treating obesity by expanding the wall of the stomach that may be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates an embodiment of a device for treating obesity by expanding the wall of the stomach that may be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates an embodiment of a device for treating obesity by expanding the wall of the stomach that may be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates an embodiment of a device for treating obesity by expanding the wall of the stomach that may be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates an embodiment of a device for treating obesity by expanding the wall of the stomach that may be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates an embodiment of a device for treating obesity by expanding the wall of the stomach that may be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates an embodiment of a device for treating obesity by expanding the wall of the stomach that may be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates an embodiment of a device for treating obesity by expanding the wall of the stomach that may be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates an embodiment of a device for treating obesity by expanding the wall of the stomach that may be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates an embodiment of a device for treating obesity by expanding the wall of the stomach that may be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates an embodiment of a device for treating obesity by expanding the wall of the stomach that may be combined with a reflux treatment device implanted in a human patient. FIG. 6 is a schematic illustration of the surface structure of any implantable device of the present invention. FIG. 6 is a schematic illustration of the surface structure of any implantable device of the present invention. FIG. 6 is a schematic illustration of the surface structure of any implantable device of the present invention. FIG. 6 is a schematic illustration of the surface structure of any implantable device of the present invention. FIG. 6 is a schematic illustration of the surface structure of any implantable device of the present invention. FIG. 6 is a schematic illustration of the surface structure of any implantable device of the present invention. FIG. 6 is a schematic illustration of the surface structure of any implantable device of the present invention. FIG. 6 is a schematic illustration of the surface structure of any implantable device of the present invention. FIG. 6 is a schematic illustration of the surface structure of any implantable device of the present invention. FIG. 6 is a schematic illustration of the surface structure of any implantable device of the present invention. FIG. 6 is a schematic illustration of the surface structure of any implantable device of the present invention. FIG. 6 illustrates various embodiments of a device for treating obesity that can be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates various embodiments of a device for treating obesity that can be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates various embodiments of a device for treating obesity that can be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates various embodiments of a device for treating obesity that can be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates various embodiments of a device for treating obesity that can be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates various embodiments of a device for treating obesity that can be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates various embodiments of a device for treating obesity that can be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates various embodiments of a device for treating obesity that can be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates various embodiments of a device for treating obesity that can be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates various embodiments of a device for treating obesity that can be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates various embodiments of a device for treating obesity that can be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates various embodiments of a device for treating obesity that can be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates various embodiments of a device for treating obesity that can be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates various embodiments of a device for treating obesity that can be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates various embodiments of a device for treating obesity that can be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates various embodiments of a device for treating obesity that can be combined with a reflux treatment device implanted in a human patient. FIG. 6 illustrates various approaches for powering a device for treating obesity that may be combined with a device for treating reflux that is implanted in a human patient. FIG. 6 illustrates various approaches for powering a device for treating obesity that may be combined with a device for treating reflux that is implanted in a human patient. FIG. 7 illustrates various approaches for powering a device for treating obesity that may be combined with a device for treating reflux that is implanted in a human patient. FIG. 6 illustrates various approaches for powering a device for treating obesity that may be combined with a device for treating reflux that is implanted in a human patient. FIG. 6 illustrates various approaches for powering a device for treating obesity that may be combined with a device for treating reflux that is implanted in a human patient. FIG. 6 illustrates various approaches for powering a device for treating obesity that may be combined with a device for treating reflux that is implanted in a human patient. FIG. 6 illustrates various approaches for powering a device for treating obesity that may be combined with a device for treating reflux that is implanted in a human patient. FIG. 6 illustrates various approaches for powering a device for treating obesity that may be combined with a device for treating reflux that is implanted in a human patient. FIG. 6 illustrates various approaches for powering a device for treating obesity that may be combined with a device for treating reflux that is implanted in a human patient. FIG. 6 illustrates various approaches for powering a device for treating obesity that may be combined with a device for treating reflux that is implanted in a human patient. FIG. 6 illustrates various approaches for powering a device for treating obesity that may be combined with a device for treating reflux that is implanted in a human patient. FIG. 6 illustrates various approaches for powering a device for treating obesity that may be combined with a device for treating reflux that is implanted in a human patient. FIG. 6 illustrates various approaches for powering a device for treating obesity that may be combined with a device for treating reflux that is implanted in a human patient. FIG. 6 illustrates various approaches for powering a device for treating obesity that may be combined with a device for treating reflux that is implanted in a human patient. FIG. 7 illustrates various approaches for powering a device for treating obesity that may be combined with a device for treating reflux that is implanted in a human patient. FIG. 6 illustrates various approaches for powering a device for treating obesity that may be combined with a device for treating reflux that is implanted in a human patient. FIG. 6 illustrates various approaches for powering a device for treating obesity that may be combined with a device for treating reflux that is implanted in a human patient. FIG. 3 illustrates various approaches for establishing hydraulic or pneumatic power supply to a device for treating obesity implanted in a human patient. FIG. 3 illustrates various approaches for establishing hydraulic or pneumatic power supply to a device for treating obesity implanted in a human patient. FIG. 3 illustrates various approaches for establishing hydraulic or pneumatic power supply to a device for treating obesity implanted in a human patient. FIG. 3 illustrates various approaches for establishing hydraulic or pneumatic power supply to a device for treating obesity implanted in a human patient. FIG. 3 illustrates various approaches for establishing hydraulic or pneumatic power supply to a device for treating obesity implanted in a human patient. FIG. 3 illustrates various approaches for establishing hydraulic or pneumatic power supply to a device for treating obesity implanted in a human patient. FIG. 3 illustrates various approaches for establishing hydraulic or pneumatic power supply to a device for treating obesity implanted in a human patient. FIG. 3 illustrates various approaches for establishing hydraulic or pneumatic power supply to a device for treating obesity implanted in a human patient. FIG. 3 illustrates various approaches for establishing hydraulic or pneumatic power supply to a device for treating obesity implanted in a human patient. FIG. 3 illustrates various approaches for establishing hydraulic or pneumatic power supply to a device for treating obesity implanted in a human patient. FIG. 3 illustrates various approaches for establishing hydraulic or pneumatic power supply to a device for treating obesity implanted in a human patient. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates various devices for treating reflux and obesity. FIG. 6 illustrates a method of surgery to treat reflux and obesity. FIG. 6 illustrates a method of surgery to treat reflux and obesity. FIG. 6 shows an embodiment of the movement restriction device in a state of a plurality of segments before assembling. FIG. 6 shows an embodiment of the movement restriction device when the first part and the second part are assembled. FIG. 109 shows the embodiment of FIG. 109 when the third and fourth parts are assembled. FIG. 112 shows the embodiment of FIG. 110 when assembling the last part. FIG. 112 shows the embodiment of FIGS. 108-111 when finally assembled. 108 is a diagram illustrating a core portion of the embodiment of FIG. 108 that includes a manipulation channel. FIG. 113 is a cross-sectional view of the core portion of FIG. 113a taken along planes I-I; II-II, III-III, IV-IV, respectively. FIG. 113 is a cross-sectional view of the core portion of FIG. 113a taken along planes I-I; II-II, III-III, IV-IV, respectively. FIG. 113 is a cross-sectional view of the core portion of FIG. 113a taken along planes I-I; II-II, III-III, IV-IV, respectively. FIG. 113 is a cross-sectional view of the core portion of FIG. 113a taken along planes I-I; II-II, III-III, IV-IV, respectively. FIG. 113 is a cross-sectional view of the core portion of FIG. 113a taken along planes I-I; II-II, III-III, IV-IV, respectively. FIG. 110 shows an alternative embodiment of the device shown in FIG. 108. FIG. 110 shows an alternative embodiment of the device shown in FIG. 108.

(Movement restriction device)
FIG. 1A is a schematic diagram showing an apparatus 11 for treating reflux disease according to the present invention, implanted in a human patient, that includes a biocompatible material migration restriction device 10. In FIG. 1A, the device 10 has been recessed into the base. The device 10 rests against a portion of the outer wall 16a of the gastric basal wall 16 at a position between the patient's diaphragm 18 and at least a portion of the lower portion of the invaginated gastric basal wall 16. A body 13 having an outer surface 15 suitable for Thus, such an invagination of the device 10 limits movement of the cardia notch of the patient's stomach toward the patient's diaphragm, thereby causing the cardia into the patient's rib cage 20. To prevent sliding through the patient's open diaphragm and maintain support pressure on the patient's cardia sphincter extending from the patient's abdomen.

The body 13 is expandable and is adapted to be expanded by a gel or fluid. A fluid or gel containing member may be provided for receiving a fluid for inflating the movement restriction device. Alternatively, the body 13 may comprise a homogeneous material and may be solid. Alternatively, the body 13 comprises an outer wall in the form of a wall defining a chamber. This outer wall may be rigid, elastic or flexible. When the outer wall is rigid, the outer wall has a rigidity high enough to maintain a state in which it does not deform even when subjected to the force generated by the movement of the stomach.

The body 13 of the movement restriction device 10 can be attached to the wall 16a of the base 16 in a variety of different ways. In the embodiment shown in FIG. 1A, device 10 is invaginated from outside the stomach into the stomach wall at the base. After invagination, a first fixation device composed of multiple gastro-gastric sutures or staples 22a is applied to keep the invagination intact for a short period of time. This allows human tissue to grow in order to maintain the invagination intact for an extended period of time.

Optionally, the wall 16a of the base 16 and the esophagus 24 to hold the device 10 in the position between the patient's diaphragm 18 and at least a portion of the lower portion of the invaginated gastric base wall 16. There may be a second fixation device composed of a plurality of sutures or staples 22b provided between itself and the wall 24a. In this case, the device 10 is attached in this position by this second fixing device. Attachment of device 10 to diaphragm muscle 18 or another muscle tissue may be performed directly or indirectly. Alternatively, the device 10 may be attached to the esophagus with His directly or indirectly. Alternatively or additionally, there is a third fixation device in the form of a suture or staple 22c provided between the wall 16a of the base 16 and the diaphragm 18 to hold the device 10 in the position described above. You may.

FIG. 1B shows an embodiment that is substantially similar to the embodiment shown in FIG. 1A. In FIG. 1B, the body 13 and invagination are secured using sutures and/or staples 22 c between the regurgitant body 13 and the diaphragm 18 in addition to the attachment 22, whereby the device is attached to the cardia 14. It will be held in the upper position.

FIG. 1C shows another embodiment that is substantially similar to the embodiment shown in FIG. 1A. In FIG. 1C, the reflux treatment device is held in place by a stomach-gastric suture or staple 22a connecting the wall 16a of the base 16 and the wall 16a of the base 16. In addition, the reflux treatment device 10 is held in place by sutures 22b or staples from the wall 16 of the base 16a to the wall of the esophagus 24a, and further by sutures or staples from the wall of the base 16a to the diaphragm. To be done.

An alternative embodiment of the device 17 for treating reflux disease according to the present invention is shown in FIG. 2A. This embodiment is in many respects similar to the embodiment described above with reference to FIGS. Accordingly, movement restriction device 10 is shown implanted in a human patient and invaginated in the base. However, in the embodiment shown in FIG. 2A, the device 10 is invaginated from the inside of the stomach, instead of being invaded from the outside of the stomach as in FIGS. The movement restriction device 10 rests against a portion of the inner wall of the gastric basal wall 16 at a position between the patient's diaphragm 18 and at least a portion of the lower portion of the invaginated gastric basal wall 16. Having a body 13 adapted to. In this embodiment, the body 13 is located above the cardia region 14 of a standing human or mammalian patient. The body 13 of the device 10 is shaped to rest against the wall 16a of the base 16 and further has an outer surface 15 suitable for resting against the wall of the base. Thus, such invagination of device 10 as described above in connection with FIG. 1A limits movement of the cardia notch of the patient's stomach toward the patient's diaphragm, This prevents the cardia from sliding through the patient's diaphragm, which is open into the patient's rib cage 20, and maintains bearing pressure on the cardia sphincter extending from the patient's abdomen.

After invagination, a plurality of gastro-gastric-sutures or staples 33a including a first fixation device are applied from inside the stomach 16 to keep the invagination intact for a short period of time. This makes it possible to grow human tissue in order to keep the invagination in perfect condition for a long period of time. Additional sutures or staples 22b, including a second fixation device, form the wall portion 16b of the base 16 and the esophagus 24 forming part of the invagination of the device 10 to hold the device 10 in the position described above. It may be provided between the wall 24a and the wall 24a. Similarly, a third anchoring device in the form of a suture or staple 22c forms another wall portion 16c of the base 16 which forms part of the invagination of the device 10 for holding the device 10 in the position described above. And the diaphragm 18 may be provided.

Another embodiment is shown in Figure 2B. This embodiment is in many ways similar to the embodiment described with reference to FIG. 2A. However, here, the suture and staples 22b and 33a are all connected to the fixation device of the reflux treatment device 10. There are no gastric-diaphragm sutures or staples in this embodiment.

As an alternative, a device 19 for treating reflux disease is shown in Figure 3A. This alternative is in many respects similar to the embodiment described above with reference to Figures 1A-C and 2A-B. Accordingly, the movement restriction device 10 is shown implanted in a human patient. The device 10 has a body 13 adapted to rest against a portion of the gastric fundus wall 16 at a location between the patient's diaphragm 18 and the gastric fundus wall 16. However, in this alternative, the device 10 is not invaginated in the stomach 16. Instead, the attachment portion of the device 10 contacts the gastric wall 16a at the base to promote the growth of human tissue to ensure that the reflux disease treatment device attached to the gastric wall is in place for an extended period of time. It has a fitting structure 10a which is a fitted, preferably net-like structure. That is, a first fixation device in the form of sutures or staples 44a may be provided between the fixture structure 10a and the base wall 16a to maintain the fixture structure 10a in place.

The attachment structure 10a is sutured between the wall 16a of the base 16 and the wall 24a of the esophagus 24 to hold the device 10 in the position between the diaphragm 18 of the patient and the wall 16 of the gastric base. It may be adapted for a second fastening device in the form of threads or staples 44b. Similarly, the attachment structure 10a also serves as a third anchoring device in the form of a suture or staple 44c that is also provided between the wall 16a of the base 16 and the diaphragm 18 to hold the device 10 in the above position. May be adapted.

An alternative embodiment is shown in Figure 3B. This embodiment is in many respects similar to the embodiment described with reference to FIG. 3A. In this embodiment, similar to FIGS. 2A-B, the reflux treatment device 10 is invaginated from the inside of the stomach. The attachment structure 10a is located on the wall 16a of the base 16 above and around the indentation formed by the reflux treatment device 10.

An alternative embodiment of the device 21 for treating reflux disease according to the present invention is shown in FIG. 4A. This embodiment is in many respects similar to the embodiment described above with reference to FIGS. In FIG. 4A, a picture of a device 10 for treating reflux disease according to the present invention is shown implanted in a human patient. In FIG. 4A, movement restriction device 10 is also recessed into base 16. The device 10 rests against a portion of the outer wall 16a of the gastric basal wall 16 at a position between the patient's diaphragm 18 and at least a portion of the lower portion of the invaginated gastric basal wall 16. A body 13 having an outer surface 15 suitable for The main body 13 has a shape that faces the outer wall 16 a of the base 16 and stands still. Thus, such an invagination of the device 10 limits movement of the cardia notch of the patient's stomach toward the patient's diaphragm, thereby causing the cardia into the patient's rib cage 20. To prevent sliding through the patient's open diaphragm and maintain support pressure on the patient's cardia sphincter extending from the patient's abdomen.

In the embodiment of FIG. 4A, similar to the embodiment of FIG. 1A, a first fixation device composed of a plurality of gastro-gastric-sutures or staples 22a after device 10 has been invaginated in base 16. Is applied to keep the invagination intact for a short period of time. A second fixation device composed of a plurality of sutures or staples 22b secures the device 10 at the position between the patient's diaphragm 18 and at least a portion of the inferior portion of the invaginated gastric base wall 16. Provided for holding. Additionally, a third fixation device in the form of sutures or staples 22c may be provided between the wall 16a of the base 16 and the diaphragm 18 also to hold the device 10 in the position.

In the embodiment shown in FIG. 4A, the size of movement restriction device 10 may be adjusted during implantation. The device 10 is tethered to a hydraulic reservoir 52 that is connected to the device 10 by leads 52b, and thus can be adjusted non-invasively by manually pressing the reservoir 52. The device 10 is further connected to one or more small chambers 10b.

Furthermore, the above embodiments may alternatively be used to treat obesity. In this embodiment, the device utilizes the volume of the movement-restricting body 13 to contain the fluid and is filled with the fluid to spread the walls of the base and provide a feeling of fullness. May be adapted to treat obesity utilizing one or more small chambers 10b connected to. The small chamber 10b is also adapted to be invaginated in the stomach wall at the base, and is filled with fluid and expanded so that human sensor feedback creates a feeling of fullness. By placing a small hydraulic reservoir/pump subcutaneously in the patient, the patient can expel hydraulic fluid to fill the small chamber to get a full stomach if desired.

An alternative embodiment is shown in Figure 4B. This embodiment is substantially similar to the embodiment shown in FIG. 4A, but the manner in which reflux treatment device 10 and chamber 10b are controlled is different. Here, the chamber 10b is controlled by a powered internal control unit 56, rather than a subcutaneous pump. The internal control unit 56 has means for the patient to control the device 10, which means is used in anticipation of treating reflux and/or obesity. The internal control unit 56 also has means for powering the device.

The body restriction unit 56 may include a battery 70, an electrical switch 72, a motor/pump 44, a reservoir 52 and an injection port 1001. An energy transfer device 34 with a remote control is adapted to control and power the device. These items are selected according to the environment in which the device is operated electrically, hydraulically, pneumatically or mechanically, for example.

The control unit can receive input from any sensor 76, in particular a pressure sensor. Any type of sensor may be provided. The internal control unit 56 is preferably an FPGA
Alternatively, it has the intelligence in the form of an MCU or ASIC, or any other circuit, component or memory (see the "System" section below for a more detailed description).

FIG. 4C shows essentially the same as FIG. 4A, except there is one small chamber 10b instead of the two small chambers of FIG. 4A. FIG. 4C shows the small chamber 10b in an empty state, and FIG. 4D shows the small chamber 10b filled and expanded to give a feeling of fullness.

Furthermore, an alternative embodiment of the device 23 for treating reflux disease according to the present invention is shown in FIG. 5A. This embodiment is again similar in many respects to the embodiment described above with reference to FIGS. Thus, similar to the embodiment of FIG. 1A, a movement restriction device 10 that is invaginated in the fundus is between the patient's diaphragm 18 and at least a portion of the lower portion of the invaginated gastric fundus wall 16. In position, it comprises a body 13 having an outer surface 15 suitable for resting facing a portion of the outer wall 16a of the gastric basal wall 16. The body 13 of the device 10 is shaped to rest against the outer wall 16a of the base 16 and has a generally smooth outer surface 15 suitable for resting against the wall of the base. After the device 10 is invaginated in the base 16, also a first fixation composed of a plurality of gastric-gastric-sutures or staples 22a to keep the invagination intact for a short time. Device is applied. To hold the device 10 in the above position, a second fixation device is provided that is composed of a plurality of sutures or staples 22b applied between the wall 16a of the base 16 and the wall 24a of the esophagus 24.

In an alternative embodiment shown in FIG. 5A, apparatus 23 is a stimulation device for delivering stimulation pulses adapted to stimulate the cardia muscle to further close the cardia to prevent further reflux disease. Further has 26. The device 23 has at least one electrical conductor 26a and at least one electrode rod 26b adapted to receive stimulation pulses.

Stimulation device 26 preferably has electronic circuitry and an energy source provided within device 10 in the preferred embodiment.

The stimulation device 26 preferably delivers the stimulation pulses as a series of pulses, where the pulse train is adapted to be repeated with a time break in between, which breaks of the pulse train. Extend the break between each pulse.

FIG. 5B shows essentially the same embodiment as FIG. 5A, but with the addition of an internal control unit 56, a remote control 28 and an external energy transfer device 34. The internal control unit 56 is connected to the stimulation device by a power lead 56b. The internal control unit 57 can have a battery 70 and an electrical switch 72, as well as other components described later in the “System” section.

The reflux disease treatment device 10 may be formed as a generally oval body, as shown in FIG. 6A, according to one embodiment of the invention. The reflux disease treatment device 10, according to another embodiment of the present invention, may be formed as an oval or spherical body with a depressed center as shown in FIG. 6B. The reflux disease treatment device 10 may be formed as a slightly curved oval body, as shown in FIG. 6C, according to yet another embodiment of the invention.

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

As discussed above, the reflux treatment device 10 is fixed in a position above the esophagus of a standing patient. To this end, one embodiment of the reflux treatment shown in FIG. 7 has a fixation device 10d that can, for example, function as a suture or staple attachment location. The fixation device may be a bend or ridge with or without holes, or may have any other shape that makes the fixation device suitable for fixing the reflux treatment device 10. You may have.

FIG. 8 illustrates one embodiment of a reflux treatment device 10, where the reflux treatment device 10 is adjustable by hydraulic means and 10e can receive hydraulic fluid to expand the device. It is an injection port. Alternatively, in one embodiment, reflux treatment device 10 changes from a smaller size to a larger size during a surgical procedure, for example, where the device is advantageously smaller initially in a laparoscopy procedure. It may be inflated. In this embodiment, any fill material, solid, liquid or gas may be injected through the injection port 10e to bring the reflux treatment device 10 to its final shape.

FIG. 9 illustrates an embodiment in which the reflux treatment device 10 has a recessed ridge 10f adapted to be held by a surgical tool. It is used, for example, during surgical procedures when a reflux treatment device is implanted.

If the reflux disease device 10 is generally spherical and thus allows the reflux disease device 10 to completely or partially surround the esophagus, the inside diameter D of the reflux disease treatment device 10 is preferably: It is sized to enclose the esophagus and at least a portion of the base, such that the device does not rest in direct contact with the walls of the esophagus when implanted.

The movement restriction device 10 can take the form of a contour that allows the device 10 to rest in a position such that the cardiac notch of the patient's stomach does not move towards the patient's diaphragm, thereby allowing the device 10 to rest. , The cardia is prevented from sliding through the patient's diaphragm, which is open into the patient's thorax, and the supporting pressure is maintained on the patient's cardia sphincter extending from the patient's abdomen.

(system)
Referring now to Figures 10-27, an energy and manipulation system, generally designated 28, incorporated into an apparatus according to the present invention will be described.

The system 28 shown in FIG. 10 has an internal energy source in the form of an implantable energy conversion device 30 adapted to supply energy to the energy consuming element of the reflux disease treatment device via a power supply line 32. Extracorporeal energy transfer device 34 has a wireless remote control that transmits a wireless signal received by a signal receiver, which may be incorporated into or separate from the implanted energy conversion device 30. The implanted energy transfer device 30 converts energy from the signal into electrical energy supplied via the power supply line 32.

The system 28 of FIG. 10 is shown in a more schematic block diagram form in FIG. 11 in which the patient's skin 36, shown in generally vertical lines, is in line with the interior of the patient 29 to the right of the line. Separated from the outside on the left side.

FIG. 11 shows a simplified block diagram showing the movement restriction device 10, an energy conversion device 30 powering the device 10 via a power supply line 32, and an extracorporeal energy transmission device 34.

12 illustrates the embodiment of FIG. 11 except that a reversing device in the form of an electrical switch 38 that is operable by polarized energy to reverse the device 10 is also implanted in the patient 29. 3 shows the same embodiment of the invention. A wireless remote control of the extracorporeal energy transfer device 34 transmits a wireless signal carrying polarization energy and the implanted energy conversion device 30 converts the polarization wireless energy into a polarization current for operating an electrical switch 38. .. When the polarity of the current is changed by the implanted energy conversion device 30, the electrical switch 38 reverses the function performed by the device 10.

FIG. 13 is similar to FIG. 11 except that an operating device 40, which is implanted in the patient for adjusting the reflux disease treatment device 10, is provided between the implanted energy conversion device 30 and the device 10. 2 illustrates the same embodiment of the invention as This operating device may be in the form of a motor 40, such as an electric servomotor. The motor 40 is powered by energy from the implanted energy conversion device 30 as the remote control of the extracorporeal energy transmission device 34 transmits a wireless signal to the receiver of the implanted energy conversion device 30.

FIG. 14 is similar to the embodiment of FIG. 11 of the present invention, except that FIG. 14 further includes an operating device in the form of an assembly 42 that includes a motor/pump unit 78 and a fluid reservoir 46 implanted in a patient. 1 illustrates an embodiment. In this case, the device 10 is hydraulically operated. That is, hydraulic fluid is urged by the motor/pump unit 44 from the fluid reservoir 46 via conduit 48 to the device 10 to operate the device, which in turn returns the device 10 to the starting position. To be pushed by the motor/pump unit 44 back from the device 10 to the fluid reservoir 46. Implanted energy conversion device 30 converts wireless energy into electrical current, eg, polarization current, for powering motor/pump unit 44 via power supply line 50.

Instead of the hydraulically operated movement limiting device 10, it may be envisaged that the operating device comprises a pneumatic operating device. In this case, pressurized air may be used for conditioning, the fluid reservoir is replaced by an air chamber and the fluid is replaced by air.

In all of these embodiments, the energy conversion device 30 may have a rechargeable accumulator, such as a battery or capacitor charged by wireless energy, to provide energy to any energy consuming part of the device. You can

The extracorporeal energy transmission device 34 is preferably wireless and may have a remotely controlled control device for controlling the device 10 from outside the human body.

Such control devices include wireless remote controls, as well as manual controls of the implanted part, most likely by the patient's hand, indirectly contacting, for example, a push button located under the skin. May be included.

FIG. 15 illustrates an embodiment of the invention having an extracorporeal energy transfer device 34 with a wireless remote control, a hydraulically operated device 10 here, and an implanted energy conversion device 30. This embodiment further comprises a hydraulic fluid reservoir 52, a motor/pump unit 44, and a reversing device in the form of a hydraulic valve shift device 54, all of which are implanted in the patient. .. Of course, the hydraulic control valve may be omitted, as the hydraulic operation can be easily carried out by simply changing the direction of the pump. The remote control may be a device separate from the extracorporeal energy transmission device or may be included in the extracorporeal energy transmission device. The motor of motor/pump unit 44 is an electric motor. In response to a control signal from the wireless remote control of the extracorporeal energy transfer device 34, the implanted energy conversion device 30 powers the motor/pump unit 44 with the energy carried by the control signal to drive the motor. /Pump unit 44 distributes hydraulic fluid between hydraulic fluid reservoir 52 and device 10. One direction in which the motor/pump unit 44 pushes fluid from the hydraulic fluid reservoir 52 to the device 10, thereby operating the device 10, and the motor/pump unit 44 fluid from the device 10 to the hydraulic fluid reservoir 52. The remote control of the extracorporeal energy transfer device 34 to switch the flow direction of the hydraulic fluid to and from the opposite direction in which the device 10 is pushed back, thereby returning the device 10 to the starting position. 54 is controlled.

16 illustrates the embodiment of FIG. 15 except that an internal control unit 56 controlled by the wireless remote control of the extracorporeal energy transfer device 34, an accumulator 58, and a capacitor 60 are also implanted in the patient. 2 illustrates an embodiment of the present invention that is the same as that of FIG. The internal control unit 56 is configured to store electrical energy received from the implanted energy conversion device 30 in the accumulator 58, which supplies energy to the device 10. In response to a control signal from the wireless remote control of the extracorporeal energy transfer device 34, the internal control unit 56 releases electrical energy from the accumulator 58 to operate the device 10 and powers the released energy to the power line. 62 or 64, or alternatively, electrical energy from the implanted energy conversion device 30 is passed through power line 66, current stabilizing capacitor 60, power line 68, and power line 64. Convert directly.

The internal control unit is preferably programmable from outside the patient's body. In a preferred embodiment, the internal control unit adjusts the device 10 to open the stomach according to a pre-programmed time schedule, or any possible physical parameter of the patient or any function of the device. It is programmed to come from any sensor that senses the parameter.

According to one alternative, the capacitor 60 of the embodiment of Figure 16 may be omitted. According to another alternative, the accumulator 58 of this embodiment may be omitted.

17 is the same as the embodiment of FIG. 10 except that a battery 70 that provides energy to operate the device 10 and an electrical switch 72 to switch the operation of the device 10 are further implanted in the patient. 1 illustrates one embodiment of the present invention. An electrical switch 72 is provided by the energy provided by the implanted energy conversion device 30 to switch from an off mode in which the battery 70 is not used to an on mode in which the battery 70 supplies energy to operate the device 10. Operated.

18 is an embodiment of the invention that is the same as the embodiment of FIG. 16 except that an internal control unit 56, which is controllable by the wireless remote control of the external energy transfer device 34, is also implanted in the patient. Is shown. In this case, the remote control is operated so as to release electrical energy from the battery 70 to operate the device 10 from an off mode in which the wireless remote control is prevented from controlling the internal control unit 56 and the battery is not used. The electrical switch 72 is operated by the energy provided by the implanted energy conversion device 30 in order to switch the internal control unit 56 into a standby mode in which it can be controlled.

FIG. 19 shows an embodiment of the invention that is the same as the embodiment of FIG. 17, except that an accumulator 58 is used in place of the battery 70 and the implanted components are individually interconnected. In this case, the accumulator 58 stores energy from the implanted energy conversion device 30. In response to a control signal from the wireless remote control of the extracorporeal energy transfer device 34, the internal control unit 56 controls the electronic switch 72, thereby operating the device 10 from an off mode in which the accumulator 58 is not used. The accumulator 58 is switched to the on mode to supply energy.

FIG. 20 shows an embodiment of the invention that is the same as the embodiment of FIG. 18, except that the battery 70 is further implanted in the patient and the further implanted components are individually interconnected. In response to a control signal from the wireless remote control of the extracorporeal energy transfer device 34, the internal control unit 56 controls the accumulator 58 to provide energy to actuate the electrical switch 72, thereby causing the battery 70. Is switched off from an unused mode in which the battery 70 supplies electrical energy to operate the device 10.

Alternatively, the wireless remote controller may operate the device 10 from an off mode that is prevented and not used to control the battery 70 to supply the electrical energy. The electrical switch 72 may be operated by the energy supplied by the accumulator 58 to switch to a standby mode that allows the battery 70 to be controlled to supply.

It should be appreciated that the switch should be construed in its broadest embodiment. This means that the FPGA or DA converter or any other electronics or electronics can be switched off and on, preferably while being controlled from outside the patient's body or by an internal control unit. ..

21 shows the motor 40, a mechanical reversing device in the form of a gear box 74, and an internal control unit 56 for controlling the gear box 74, which is additionally implanted in the patient. 1 illustrates the same embodiment of the invention as the embodiment. The internal control unit 56 controls the gear box 74 (mechanically operated) to reverse the function performed by the device 10. A simpler form is to electronically switch the direction of the motor.

22 illustrates one embodiment of the invention that is the same as the embodiment of FIG. 20, except that the components to be implanted are individually interconnected. Thus, in this case, the internal control unit 56 is powered by the battery 70 when the accumulator 58, preferably the capacitor, activates the electrical switch 72 to switch to the on mode. When the electrical switch 72 is in the on mode, the internal control unit 56 will be able to control the battery 70 to provide or not provide energy to operate the device 10.

FIG. 23 schematically illustrates possible combinations of implanted components of the device for implementing various communication options. Basically, there is a device 10, an internal control unit 56, a motor or pump unit 44, and an external energy transfer device 34 that includes an external wireless remote control device. As previously described above, the wireless remote control device transmits control signals received by the internal control unit 56 to control various implanted components of the device.

A feedback device, preferably in the form of a sensor 76, may be implanted in the patient to sense a physical parameter of the patient, such as an esophageal contraction wave that signals that the patient is eating. An internal control unit 56, or alternatively an external wireless remote control of the external energy transmission device 34, can control the device 10 in response to a signal from the sensor 76. A transceiver may be associated with the sensor 76 to send information regarding the sensed physical parameter to the extracorporeal wireless remote control. The wireless remote control may have a signal transmitter or transceiver and the in-body control unit 56 may have a signal receiver or transceiver. Alternatively, the wireless remote controller may have a signal receiver or transceiver and the internal control unit 56 may have a signal transmitter or transceiver. The transceivers, transmitters and receivers described above may be used to send information or data related to the device 10 from inside to outside the patient's body.

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

When the motor/pump unit 44 and the battery 70 for powering the motor/pump unit 44 are implanted, the battery 70 may include a transceiver for sending information regarding the status of the battery 70. More precisely, when the energy is used to charge the battery or accumulator, feedback information relating to the charging process is sent and the energy supply is changed accordingly.

FIG. 24 illustrates an alternative embodiment in which the device 10 is adjusted from outside the patient's body. The system 28 has a movement restriction device 10 connected to a battery 70 via a subcutaneous switch 80. Therefore, the adjustment of the device 10 is performed non-invasively by manually pressing the subcutaneous switch, which switches the operation of the device 10 on and off. It is to be understood that the illustrated embodiments are simplified and that additional components such as an internal control unit or any other portion disclosed herein may be added to the system. ..

FIG. 25 illustrates an alternative embodiment in which the system 28 has a movement restriction device 10 fluidly connected to a hydraulic fluid reservoir 52. Non-invasive adjustment is performed by manually pressing the hydraulic reservoir connected to the device 10.

Another embodiment of a system incorporated into a device according to the invention is for providing feedback information regarding at least one functional parameter of the movement restriction device or device or a physical parameter of the patient, thereby optimizing the operation of the device. , Having a feedback device that sends information from inside the patient's body to the outside.

One suitable functional parameter of the device corresponds to the transfer of energy to charge the internal energy source.

In FIG. 26, one configuration is schematically shown for delivering the correct amount of energy to a system 28 implanted in a patient whose skin 36 is shown in vertical lines. The movement restriction device 10 is connected to an implanted energy conversion device 30 which is also located inside the patient and is preferably located just below the patient's skin 36. Generally speaking, the implanted energy conversion device 30 may be placed in the abdomen, thorax, fascia (eg, within the abdominal wall), subcutaneously, or any other suitable location. The implanted energy conversion device 30 is wireless energy transmitted from an extracorporeal energy source 34a provided within an extracorporeal energy transmission device 34 located outside the patient's skin 36 proximate to the implanted energy conversion device 30. Adapted to receive E.

As is well known in the art, wireless energy E is generally associated with a primary coil located within the extracorporeal energy source 34a and an adjacent secondary coil located within the implanted energy conversion device 30. Can be delivered using any suitable Transcutaneous Energy Transfer (TET) device, such as a device including When a current is supplied through the primary coil, energy in the form of a voltage is induced in the secondary coil, which energy is stored, for example, by an energy storage device, such as a battery or a capacitor, or an accumulator, after storing the incoming energy. It can be used to activate a movement restriction device. However, the invention is not generally limited to any particular energy transfer technology, TET device or energy storage device, and any type of wireless energy may be used.

The amount of energy received by the device inside the body can be compared to the amount of energy used in the device. It should be understood that the term "used in the device" also includes the energy stored by the device. The amount of energy transferred may be adjusted by the extracorporeal control unit 34b, which controls the extracorporeal energy source 34a based on a predetermined energy balance, as described above. To deliver the correct amount of energy, the energy balance and the amount of energy required can be determined by the internal control unit 56 connected to the reflux disease treatment device 10. Thus, the internal control unit 56 measures in some way the amount of energy obtained by a suitable sensor, that is, not shown, to measure certain characteristics of r10 and to operate the device 10 properly. It may be configured to receive various measurements obtained thereby. Further, the current condition of the patient may also be sensed by a suitable measuring device or sensor to provide parameters indicative of the patient's condition. Thus, these characteristics and/or parameters are related to the current state of the device 10, such as power consumption, operating mode and temperature, as well as the patient's state as indicated by, for example, temperature, blood pressure, heartbeat and respiration. You can

Further, an energy storage device or accumulator 58 may optionally be connected to the implanted energy conversion device 30 to store the received energy for later use by the device 10. Alternatively or additionally, the properties of such accumulators, which also indicate the amount of energy required, may be measured. The accumulator may be replaced by a battery and the characteristic being measured may be related to the current state of the battery such as voltage, temperature and the like. In order to provide sufficient voltage and current to the device 10, as well as to prevent excessive heating, the battery receives a reasonable amount of energy from the implanted energy conversion device 30, not too little or too much. It should be appreciated that by means of which it must be optimally charged. The accumulator may be a capacitor with corresponding characteristics.

For example, the characteristics of the battery may be periodically measured to determine the current state of the battery, which may be stored in a suitable storage means within the internal control unit 56 as information regarding the state. Thus, as new measurements are obtained, the stored information about battery status may be updated accordingly. In this way, the state of the battery can be "calibrated" by delivering the right amount of energy, thereby maintaining the battery in optimal condition.

Therefore, the internal control unit 56 is based on the measurements obtained by the sensors or measuring devices mentioned above of the reflux disease treatment device 10 or the patient or the energy storage device if used or any combination thereof, It is adapted to determine the energy balance and/or the amount of energy currently required (energy per unit time or energy stored). The intracorporeal control unit 56 is further connected to an intracorporeal signal transmitter 82 configured to transmit a control signal indicative of the determined required amount of energy to an extracorporeal signal receiver 34c connected to the extracorporeal control unit 34b. To be done. In this case, the amount of energy transmitted from the extracorporeal energy source 34a can be adjusted in response to the received control signal.

Alternatively, the sensor readings may be transmitted directly to the extracorporeal control unit 34b, where the energy balance and/or the amount of energy currently required may be determined by the extracorporeal control unit 34b, thus The functions of the internal control unit 56 described above are incorporated in the external control unit 34b. In this case, the internal control unit 56 may be omitted, and the sensor measurements are fed directly to the internal signal transmitter 82, which transmits these measurements to the external signal receiver 34c and the external control unit 34b. Send to. Thereafter, based on these sensor measurements, the energy balance and the amount of energy currently needed can be determined by the extracorporeal control unit 34b.

Therefore, this solution employs feeding back information indicating the required energy, which is more efficient than the conventional solution. This is because of the energy that is compared to the energy received, for example, based on the amount of energy, the energy difference, or the energy rate received that is compared to the energy rate used by device 10. This is because it is based on the actual amount used. The device 10 may use the received energy, either for consuming energy or storing it in an energy storage device or the like. Therefore, the parameters discussed above are used as a tool to determine the actual energy balance when they are relevant and required. However, these parameters may also be required by nature, especially for any operation performed internally to activate the device.

The internal signal transmitter 82 and the external signal receiver 34c may be implemented as separate units using suitable signal transmission means such as radio, IR (infrared) or ultrasonic signals. Alternatively, the intracorporeal signal transmitter 82 and the extracorporeal signal receiver 34c may be integrated into the implanted energy conversion device 30 and extracorporeal energy source 34a, respectively, using essentially the same transmission techniques. Thus, control signals can be sent in the opposite direction when transmitting energy. The control signal may be modulated in frequency, phase or amplitude.

In summary, the energy supply arrangement shown in Figure 26 operates basically in the following manner. First, the energy balance is determined by the internal control unit 56. A control signal indicating the amount of energy required is further generated by the internal control unit 56, and the control signal is transmitted from the internal signal transmitter 82 to the external signal receiver 34c. Alternatively, the energy balance may be determined by the extracorporeal control unit 34b, instead of relying on the instrument described above. In this case, the control signal can carry measurement results from various sensors. The amount of energy emitted from the extracorporeal energy source 34a may then be adjusted by the extracorporeal control unit 34b based on the determined energy balance, eg, in response to the received control signal. This process may be repeated intermittently at specific intervals while continuing to transfer energy, or may be performed to some extent in transferring energy.

The amount of energy transferred can generally be adjusted by adjusting various transfer parameters of the extracorporeal energy source 34a, such as voltage, current, amplitude, wave frequency, and pulse characteristics.

In this way, a method of controlling the transmission of wireless energy delivered to an electrically operated reflux disease treatment device implanted in a patient is provided. The wireless energy E is transmitted from an extracorporeal energy source located outside the patient and is located inside the patient, which is connected to the device 10 to directly or indirectly supply the received energy to the device 10. Received by the internal energy receiver. energy·
The balance is determined between the energy received by the internal energy receiver and the energy used in the device 10. The transmission of wireless energy E from the extracorporeal energy source is then controlled based on the determined energy balance.

Also provided is a system for controlling the transmission of wireless energy delivered to an electrically operated movement restriction device 10 implanted in a patient. The system is adapted to transmit wireless energy E from an extracorporeal energy source located external to the patient, which wireless energy E supplies the received energy to device 10 directly or indirectly. Received by an implanted energy conversion device located inside the patient, which is connected to the device 10. The system further determines an energy balance between the energy received by the implanted energy conversion device and the energy used in the device 10, and wireless energy from an extracorporeal energy source based on the determined energy balance. It is adapted to control the transmission of energy E.

The functional parameters of the device correspond to the transfer of energy to charge the internal energy source.

In a further alternative embodiment, an extracorporeal energy source is controlled from outside the patient's body to release electromagnetic wireless energy, and the released electromagnetic wireless energy is used to operate device 10. ..

In another embodiment, an extracorporeal energy source is controlled from outside the patient's body to release non-magnetic wireless energy, and the released non-magnetic wireless energy is used to operate device 10. It

Those skilled in the art will appreciate that the various embodiments described above according to FIGS. 14 to 26 can be combined in many different ways. For example, an electric switch 38 operated by polarization energy may be incorporated into any of the embodiments of FIGS. 12, 15-21 and a hydraulic valve shift device 54 may be incorporated into the embodiment of FIG. , Gear box 74 may be incorporated into the embodiment of FIG. Note that switch simply means any electronic circuit or device.

The wireless transmission of energy to activate the movement restriction device 10 has been described for enabling non-invasive operation. It should be appreciated that the device 10 may also be operated by wire bound energy. One such example is shown in FIG. 26, where an extracorporeal switch 84 is coupled between extracorporeal energy source 34a and an operating device such as an electric motor that regulates device 10 by power lines 86 and 88. Interconnected. The extracorporeal control unit 34b controls the activation of extracorporeal switches so that the device 10 is properly activated.

(Hydraulic or pneumatic power supply)
28-31 show more detailed block diagrams of four different schemes of hydraulically or pneumatically powering a movement restriction device according to the present invention.

FIG. 28 shows a system for treating reflux disease, described above. The system includes the device 10 and further includes a separate regulated reservoir 46, a one-way pump 44, and a reciprocal valve 54.

FIG. 29 shows device 10 and fluid reservoir 46. By moving the wall of the regulating reservoir or by changing the size of the regulating reservoir in any other way, the adjustment of the device can be done without any valve and by moving the wall of the reservoir. The fluid is always free to move.

FIG. 30 shows the device 10, a two-way pump 44 and a regulated reservoir 46.

FIG. 31 shows a block diagram of a reburst servo system in which a first closed system controls a second closed system. The servo system has a conditioning reservoir 46 and a servo reservoir 90. The servo reservoir 90 mechanically controls the movement restriction device 10 via a mechanical interconnect 94. The device 10 has an expandable/contractible cavity. The cavity may be expanded or contracted, preferably by supplying hydraulic fluid from a large adjustable reservoir 92 fluidly connected to the device 10. Alternatively, the cavity contains a compressible gas, which may be compressed or expanded under the control of servo reservoir 90.

The servo reservoir 90 may be part of the device itself.

In one embodiment, the conditioning reservoir is placed subcutaneously under the patient's skin and manipulated by pushing its outer surface with a finger. This reflux disease treatment system is shown in Figure 32-c. In FIG. 31, a flexible adjustment reservoir 46 under the skin is shown connected by a conduit 48 to a raised servo reservoir 90. The bellows type servo reservoir 90 is included in the flexible travel limiting device 10. In the situation shown in FIG. 32, the servo reservoir 90 contains minimal fluid and most of the fluid is found in the regulated reservoir 46. Since the servo reservoir 90 and the device 10 are mechanically interconnected, the outer shape of the device 10 is in a contracted state. That is, the device 10 will occupy less than the maximum volume. This maximum volume is indicated by the dotted line in this figure.

FIG. 32 shows a user, such as a patient, having a device implanted therein, depressing the conditioned reservoir 46, thereby pumping the fluid contained therein to flow through the conduit 48. And is encased in the servo reservoir 90, which causes the servo reservoir 90 to expand longitudinally due to its bellows shape. This expansion then causes the device 10 to expand and occupy the maximum volume, thereby expanding the stomach wall (not shown) with which the device 10 is in contact.

The conditioning reservoir 46 preferably comprises means 46a for maintaining its shape after compression. Thus, by this means, which is schematically shown in the figure, the device 10 maintains its expanded position even when the user releases the regulating reservoir. In this way, the regulatory reservoir essentially acts as an on/off switch for the reflux disease treatment system.

An alternative embodiment of hydraulic or pneumatic operation will now be described with reference to Figures 33 and 34. The block diagram shown in FIG. 33 includes a first closed system that controls a second closed system. This first system has a conditioning reservoir 46 and a servo reservoir 90. The servo reservoir 90 mechanically controls a large adjustable reservoir 92 via a mechanical interconnect 94. A movement restriction device 10 having an inflatable/deflateable cavity is then provided with hydraulic fluid from a large adjustable reservoir 92 that is fluidly connected to the device 10 to allow the large adjustable reservoir 92 to Controlled.

Next, an example of this embodiment will be described with reference to FIG. As in the previous embodiment, the conditioned reservoir is placed subcutaneously under the patient's skin and manipulated by pushing its outer surface with a finger. The adjusting reservoir 46 is a bellows type servo reservoir 9 via a conduit 48.
Fluidly connected to 0. In the first closed system 46, 48, 90 shown in FIG. 32 a, the servo reservoir 90 contains a minimal amount of fluid, with most of the fluid found in the conditioning reservoir 46.

The servo reservoir 90, which again has a bellows shape in this embodiment, is mechanically connected to a larger adjustable reservoir 92 having a larger diameter than the servo reservoir 90. A large adjustable reservoir 92 is fluidly connected to the device 10. This is because the user pushes the adjustment reservoir 46 to displace the fluid from the adjustment reservoir 46 to the servo reservoir 90, which causes the servo reservoir 90 to expand, thereby allowing a large amount of fluid from the large adjustable reservoir 92 to the device. It means that it is displaced up to 10. That is, in this reburst servo, the adjustment reservoir having a small volume is squeezed with a strong force, thereby moving a larger total area with a weak force per unit area.

Similar to the previous embodiment described above with reference to Figures 32a-c, the conditioning reservoir 46 preferably comprises means 46a for maintaining its shape after compression. Thus, by this means, which is schematically shown in the figure, the device 10 maintains its extended position even when the user releases the regulating reservoir. In this way, the regulatory reservoir essentially acts as an on/off switch for the reflux disease treatment system.

In FIG. 35, a flow chart shows the steps performed when implementing a device according to the invention. First, in step 102, an opening is incised in the abdominal wall. Next, at step 104, the area around the stomach is dissected. Then, at step 106, at least one movement restriction device according to the invention is placed in contact with the stomach wall, in particular the wall of the fundus. Then, in step 108, the stomach wall is sutured.

(Method of repairing the cardia and base)
FIG. 36 illustrates an approach in which a device 200 having at least one flexible portion 201 is introduced into the esophagus 24 of a patient with an esophageal hiatus hernia 202, where a portion of the esophagus 24 and the diaphragm 18 are shown. The base 16, which should be below, has moved through the hiatus opening 18a to a position above the diaphragm 18.

FIG. 37 shows a method in which the member 203 having a larger cross-sectional area than the above-described device 200 is released from the device 200 in the next step. The member 203 is adapted to have a larger cross-sectional area than the opening of the cardia 14. This is accomplished by the member 203 being radially expanded. The instrument 200 is then pushed proximally, causing the improperly located cardia 14 and base 16, or a portion of the base 16, to slide through the lacunae 18a to cause the diaphragm. It is returned to the proper position below 18.

FIG. 38 illustrates an alternative method to the method shown in FIG. 37, which is an embodiment of the present invention. This figure is in many respects similar to FIG. In FIG. 38, the device 200 is adapted to release the balloon member 204 at the proximal end 205 of the device 200 in the lower portion 206 of the stomach, and further to the cardia 14 and the base 16, or base. 16 is adapted to push the device 200 against the inferior wall portion 207 of the stomach using a balloon 204 to allow a portion of 16 to slide through the lacunae 18a to a position below diaphragm 18. It

FIG. 39 illustrates a further alternative method that is an embodiment of the present invention. This figure also resembles FIG. 37 in many respects. However, in FIG. 39, the method includes attaching the member 203 to the wall of the stomach 207 by means of the anchor 208. The instrument is then pushed proximally and the cardia 14 and base 16, or a portion of base 16 is slid below diaphragm 18 as described above.

FIG. 40 illustrates an approach in which the base 16 and the cardia 14 are positioned below the diaphragm 18 after being pushed through the hiatus opening 18a by the device 200.

FIG. 41 shows the next step in the method. After the base 16 and the cardia 14 have been pushed into place below the diaphragm 18, the walls of the base 16a are attached to the lower portion of the esophagus 24. This is done using a member 209 on the proximal portion 205 of the instrument 200 that can form sutures or staples 210. This fixation prevents the cardia 14 and the base 16 from moving to a position above the diaphragm 18.

Another method according to the invention is briefly described below.

A method for treating reflux disease in a patient comprises implanting a reflux disease treatment system according to the present invention into the body of a patient.

The method of using the system for treating reflux disease according to the present invention comprises the step of adjusting the device for preventing reflux postoperatively.

A method of surgically placing a movement restriction device in a patient according to the invention comprises cutting an opening in the abdominal wall of the patient, incising an area around the stomach, and attaching the movement restriction device to the stomach wall. And sewing the stomach wall.

A method of using a postoperative externally controlled reflux disease treatment system to adjust the device includes the steps of filling a volume attached to a portion of the stomach wall and the patient to affect the patient's reflux. Adjusting the device from outside the body.

A method of using a movement restriction device includes the steps of filling a volume in a first portion of a gastric wall by arranging a first portion of the device and arranging a second portion of the device by arranging a second portion of the device. The steps include filling a volume in the second portion, and adjusting the device from outside the patient's body to affect patient reflux.

Methods for treating reflux disease in a patient include inserting a needle or tubular device into the abdomen of the patient's body and a needle or tubular device to fill the patient's abdomen with gas to expand the abdominal cavity. Of the at least two laparoscopic trocars, placing at least two laparoscopic trocars in the patient's body, inserting a camera into the patient's abdomen through one laparoscopic trocar; Inserting at least one dissector through one of the two to dissect the intended placement area of at least a portion of the patient's stomach; placing the movement restriction device according to the present invention in the wall of the gastric fundus; Invading the device into the wall of the fundus, suturing the stomach wall to the stomach wall itself to maintain the device in place, suturing the fundus of the stomach to the lower portion of the esophagus, Preventing the cardia from sliding upward through the diaphragm and into the thorax. By using the methods and devices described herein, gastroesophageal reflux is highly efficient and free of complications such as tissue damage and undesired entry of non-tissue into the tissue. A cure for the disease is established.

The filling body of the device can be adapted to be pushed and pulled through the trocar used for laparoscopy, where the trocar has a smaller diameter when the body is loose. The fill body may have an outer wall and a hollow gas filled inner portion to allow the body to pass through the trocar. Alternatively, the fill body may have an outer wall and a hollow, fluid-filled inner portion to allow the body to pass through the trocar. In the latter case, the fluid may be a gel. The filling body may further have a plurality of parts that can be inserted into the trocar and can be assembled together into one single piece inside the patient's body, whereby the filling body passes through the trocar. become able to. The filling body may have an outer wall and a hollow compression inner portion that is filled with a fluid or gel after being inserted into the patient's body. The fill body may further have an injection port, which after insertion may be used to fill the fill body with fluid via the injection port.

The filling body of the device may be a compressible elastic material, which allows the filling body to pass through the trocar. The filling body may be made of a material softer than 25 shure or even 15 shure.

The filling body can also have an outer wall that is substantially in the shape of a ball. The filling body can also have at least one holding device adapted to be used to push and pull the filling body through a trocar used for laparoscopy. The retaining device may be adapted to retain an additional portion of the device adapted to be retained by the surgical instrument. The holding device can also hold a tread or band inserted through the holding device. This retaining device may also be arranged at least partly inside the outer wall of the filling body. The filling body of the device may suitably have a larger size than the exit of the intestinal tract from the stomach, in order to prevent ileus in case the ball enters the stomach as a complication. Suitably, the body has a minimum outer diameter of between 30 mm and 40 mm or greater. Suitably, the body has a minimum outer circumference of between 30 mm and 150 mm.

A preferred embodiment of a device for treating reflux disease, a system including a device for treating reflux disease, and a method according to the invention has been described. Those skilled in the art will appreciate that these can be modified within the scope of the appended claims. Thus, although particular features have been described in particular embodiments, it is to be understood that they may be combined in other configurations where applicable. For example, although hydraulic control has been described in connection with the device configurations of FIGS. 4A-B, this may also apply to the device configurations of FIGS. 2A-B and 3A-B.

It is important that the implanted reflux treatment device be firmly maintained in place within the stomach wall where the reflux treatment device is invaginated. To this end, the reflux treatment device can include one or more through holes adapted to receive sutures or staples used to secure the invaginated portion. Such an embodiment is shown in FIG. 42, wherein the reflux treatment device 10 comprises a row of holes 10i provided on a protruding flange-like protrusion on the reflux treatment device. In this embodiment, the row of holes extends along the longitudinal axis of the reflux treatment device.

FIG. 43 shows how the suture 314 is provided to penetrate the stomach wall 12a and then the hole 10i. In this way, the reflux treatment device is locked in place in the bag made by the stomach wall and thus prevented from sliding.

Although multiple holes are shown in FIG. 42, it should be understood that a single hole is sufficient to improve securing the reflux treatment device 10.

FIG. 44 shows a reflux treatment device with an inlet port 10h. The reflux treatment device is invaginated in the stomach wall and the inlet port 10h may be used to connect to a tube or the like from the patient's abdominal region.

FIG. 45 illustrates an invaginated reflux treatment device where a fixed tube 10g extends into the patient's abdominal region instead of the inlet port.

46 is a view similar to FIG. 44, but further showing tunneling of the connecting tube 10g in the stomach wall between the inlet port 10h and the reflux treatment device 10.

It has been shown that the shape of a reflux treatment device can take many different forms. It should be appreciated that the materials of the reflux treatment device may also vary. Suitably, the reflux treatment device comprises a coating such as a parylene coating, a polytetrafluoroethylene (PTFE) coating or a polyurethane coating, or a combination or multilayer coating of these coatings. The coating or multilayer coating improves the properties of the reflux treatment device, such as water resistance.

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

The unexpanded inflatable reflux treatment device is shown in Figure 47a. This inflatable reflux treatment device is essentially a deflated balloon-like device 10 having an inlet port 10h. In this state, the inflatable device has a diameter of up to a few millimeters and can therefore be inserted through the patient's esophagus and into the stomach by the tubular gastroscopy instrument 600 shown in FIG. 47b. The device has an outer sleeve 600a and an inner sleeve 600b that can be displaced longitudinally with respect to the outer sleeve. The inner sleeve comprises a cutter in the form of a cutting edge 615 at the distal end. This cutting edge can be used to cut a hole in the stomach wall, as described in detail below.

When the device reaches the stomach wall, the inner sleeve is advanced forward from a position in the outer sleeve to contact the stomach wall 12a, as seen in Figure 47c. The inner sleeve cutting edge 615 then cuts a hole in the stomach wall, thereby allowing the reflux treatment device 10 to be inserted therethrough as seen in FIG. 47d. A piston 602 may be provided on the device to push the reflux treatment device through the hole. Accordingly, the instrument further comprises a piston 602 adapted to push the deflated reflux treatment device 10 from a position within the inner sleeve shown in FIG. 47b to a position outside the inner sleeve shown in FIG. 47d.

Another protective sleeve (not shown) may be provided around the reflux treatment device to protect the deflated reflux treatment device 10 from the inner sleeve cutting edge 615.

Next, an intraluminal technique for invading the reflux treatment device 10 to the outside of the stomach wall 12a will be described with reference to FIGS. First, as seen in FIG. 48a, an instrument 600, preferably a gastroscopy instrument, is inserted into the patient's mouth. The device has injection devices 601, 602 for injecting either a fluid or a device into the stomach of a patient. The instrument 600 further comprises a control unit 606 adapted to control the operation of the instrument. To this end, the control unit 606 has one or more steering devices in the form of two joysticks 603 and two control buttons 604 in the illustrated embodiment. As seen in FIGS. 48e-i, a display 605 is provided to display the image provided by a camera (not shown) located at the outer end of the elongated member 607. The camera may be assisted by a light source (not shown).

The device is further inserted into the esophagus and into the patient's stomach, as seen in Figure 48b. The device 600 creates a hole 12b in the wall of the stomach 12. For this purpose, the instrument comprises one or more cutters 615 at the distal end, for example in the form described above with reference to Figures 47a-d. Of course, these cutters may be variously designed, such as a toothed drum cutter that rotates around the central axis of the tubular instrument. The instrument 600 is hollow so as to form a space for the deflated reflux treatment device 10.

After the hole is made in the stomach wall, the distal end of the device 600 is inserted through the hole 12b to reach the outside of the stomach wall 12a. This is shown in FIG. 48c, which is a side view of stomach 12 and FIG. 48d, which is a cross-sectional view of the stomach of FIG. 48c taken along line Vd-Vd. The deflated reflux treatment device 10 is then inserted into this abdominal region.

The device 600 is adapted to create a "pocket" or "bag" on the outside of the stomach 12 around the hole 12b in the stomach wall. Next, the equipment and method for making this bag will be described.

48e-i show a gastroscopy or laparoscopy instrument for invading the reflux treatment device 10 into the patient's stomach wall 12a by making a bag of material in the stomach wall 12a for placement of the reflux treatment device. ing. This device, generally indicated at 600, which may have the features described above with reference to Figures 47a-d, has an elongated member 607 having a proximal end and a distal end, the elongated member 607 has a diameter that is smaller than the diameter of the patient's esophagus and is flexible; It can be introduced so that it can be passed through to reach the stomach wall 12a.

A gastric penetrating device or cutter 615 for penetrating the stomach wall 12a is provided at the distal end of the elongated member 607 to create a hole in the stomach wall 12a and allow the elongated member 607 to be introduced therethrough. The gastric penetrating device 615 may be adapted to operate to be retracted after the gastric basal wall 12a has been pierced so as not to further damage tissue within the body. The instrument further comprises a special retention device 609 provided on the elongate member 607 proximal of the penetrating device 615.

The elongate member further comprises an expandable member 611 adapted to be expanded after the elongate member has penetrated the stomach wall 12a, thereby creating a cavity or bag adapted to hold the reflux treatment device 610. Assist in. The inflatable member 611 may include an inflatable circular balloon provided on a circumference around the distal end portion of the flexible elongate member 607.

Next, the method steps in invading a reflux treatment device will be described in detail. After the device 600 is inserted into the stomach 12, a gastric penetrating device 615 is placed therein to contact the gastric wall 12a as seen in Figure 48e. The gastric penetrating device or cutter 615 is then extruded to create the hole 12b in the stomach wall, after which at least the inflatable member 611 is extruded through the hole 12b in the stomach wall. In this step, the special holding device 609 is pushed out into the holding state, where it presents an essentially circular abutment surface against the stomach wall 12a as seen in Fig. 48f. It expands radially to form. In this way, insertion of gastric penetrating device 615 and inflatable member 611 through hole 12a in the stomach wall is limited to the position shown in Figure 48f.

The expandable member 611 is then expanded. In this case, the inflatable member comprises a balloon or the like into which air or another fluid is infused.

The portion of the elongate member 607, including the inflatable member 611, is then retracted proximally as shown by the arrow in FIG. 48g, whereby the stomach wall 612 is a basket-like structure created by a special retention device 609. It is pulled inward.

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 has a suture or stapling end 613 adapted to close a cavity or bag with a gastro-gastric suture or staple 14.

The next step, shown in FIG. 48h, is to place the inflatable reflux treatment device 10 in its collapsed state within this basket-like structure. The reflux treatment device 10 is then expanded to the expanded or expanded state seen in FIG. 48i. This expansion of the reflux treatment device 10 may be accomplished by injecting a fluid or gel into the deflated reflux treatment device. This may be achieved by injecting a curable material, which forms a solid device 10. Thus, the reflux treatment device 10 shown in FIGS. 48h and 48i is a balloon-like device that is later filled with a fluid or gel, or, alternatively, simply injected into the basket-like structure formed by the stomach wall 12a. May be considered to represent any of the materials mentioned.

The fluid used to fill the reflux treatment device 10 may be any suitable fluid suitable for filling the expandable device 10, such as saline. In another embodiment, if the fluid is a fluid adapted to be transformed into a solid phase, the fluid may be liquid polyurethane.

The fluid is isotonic to minimize or completely prevent leakage. That is, the fluid has the same osmolarity as human body fluids. Another approach to prevent diffusion is to provide fluids containing macromolecules such as iodine molecules.

The stomach-stomach-suture or staple is preferably a net adapted to contact the stomach wall to promote in-growth of body tissue and fix the position of a reflux treatment device attached to the stomach wall for an extended period of time. And a fixed portion forming a structure such as a structure.

After a portion or all of the inflatable device 10 is inflated, the inlet port 10b (not shown in FIGS. 48h and 48i) of the reflux treatment device 10 is sealed, the device 600 is retracted from the hole 12b, and then the hole 12b is removed. It may be closed in any suitable manner, such as by instrument 600 or the like. The instrument is then removed from the stomach 600 and the inflatable device 10 in the inflated or expanded state is invaginated on the stomach wall portion of the patient, outside the stomach wall. In one or more of the steps described above, the stomach may be inflated with gas, preferably using a gastroscopy instrument.

The reflux treatment device 10 described above with reference to Figures 48a-i has been described as an inflatable reflux treatment device. The reflux treatment device 10 may be an elastic reflux treatment device having elasticity such that it can be compressed for insertion into a gastroscopy instrument and expanded to an expanded state after being removed from the instrument. I want you to understand.

A device for treating reflux may have the additional function of treating obesity. In such an embodiment, the reflux treatment device may be a volume filling device for occupying the volume of the stomach and thereby providing a feeling of fullness.

The embodiment shown in FIG. 49 shows an elongated movement restriction device 301 having a proximal portion 301′ and a distal portion 301″. The device 310 includes a proximal portion 301′ when the patient is standing. Close to and at least partially above the patient's cardia 14, it is invaginated in the stomach wall and secured in position above the cardia region 14c by a fastener such as suture or staple 22. For example, fixation to the diaphragm muscle or another muscle tissue may occur directly or indirectly, as an alternative, it may be directly or indirectly fixed to the esophagus close to and above the His angle. In this embodiment, the proximal portion 310' of the device rests in the position facing the stomach wall of the fundus when implanted and further occupies the volume above the cardia region 14c between the cardia and the diaphragm muscle. , Thereby preventing the cardia from sliding up into the thoracic cavity, thereby preventing reflux disease. The distal portion 301" stabilizes and holds the proximal portion and its stabilizing action. Long enough to last. The distal portion 301 ″ also has sufficient volume to reduce the volume of the hood cavity, thereby providing the device with additional functionality for treating obesity.

Such devices 310 may be used to maintain electronics and/or energy sources and/or hydraulic fluids. Hydraulic fluid from this device is distributed over the area of multiple smaller inflatable devices to change the expansion area over time to prevent any expansion effect on the stomach wall from becoming more permanent. Can be done. In addition, mechanical expansion areas may also be used.

In the alternative embodiment shown in FIG. 50, the volume of inflatable reflux treatment device 310 may be fluidly connected to one or more, preferably small, inflatable devices or chambers 10b. These chambers are adapted to be in communication by fluid or air moving between the chambers.

Thus, the large chamber 310 is adapted by its main volume to be a reflux treatment device for reducing the size of the hood cavity and for treating reflux disease as well as one or more small chambers. Is adapted to function as an inflatable device for treating obesity, wherein the main chamber is adapted to be communicated with a small chamber by fluid or air, thereby A dilation effect is provided, which further treats obesity.

FIG. 51 illustrates an embodiment with a combination of a volume filling device that is invaginated in the mid or lower portion of the stomach and an expansion device that is invaded in the upper or basal portion of the patient's stomach. These two devices work to treat obesity.

The volume filling device 399 occupies the volume of the stomach and gives a feeling of fullness. The expansion device widens the wall of the stomach. This dilation device widens the tissues that transmit signals that give a feeling of fullness to the endogenous. This expansion device mimics the expansion effect of filling the stomach with food. Thus, in FIG. 51, an adjustable volume filling device 399 is shown that is invaginated in the stomach wall of the patient's stomach 312. Additionally, an adjustable expansion device 350 with the functionality described above is invaginated in the wall of the patient's gastric fundus. The volume filling device 399 is preferably substantially larger than the expansion device 350.

Volume filling device 399 and expansion device 350 can be adapted to treat reflux. In one embodiment, the volume filling device and expansion device are positioned to prevent the cardia 14 from sliding upward through the opening in the hernia 18a to a position above the diaphragm 18.

The volume filling device 399 and the expansion device 350 are in fluid communication with each other via a first fluid line 352 having a pump 354 therein. The pump 354 has a power supply line 356.
Is under the control of an energy conversion device 330 adapted to supply energy to the pump 350 via. The energy conversion device 330 is also connected to a sensor 319 located in the patient's esophagus so that food intake can be sensed.

The reflux treatment device 10 and the dilation device 350 are further in fluid communication via a second fluid conduit 358, which preferably has a smaller cross-sectional area than the first fluid conduit 352.

The operation of this configuration is as follows. The volume filling device 399 functions as in the embodiments described above. That is, the volume filling device 399 reduces the size of the hood cavity of the patient's stomach 12. Additionally, when expansion device 350 is expanded by the fluid being pumped from volume filling device 10 to expansion device 350 by pump 354, the walls of the gastric fundus are expanded, giving the patient a feeling of fullness. Thus, for example, when food intake is sensed by sensor 319, fluid is automatically pushed into expansion device 350 to enhance satiety and thereby limit food intake.

When fluid is injected into expansion device 350, its internal pressure is higher than the internal pressure of fluid therapy device 399. This pressure differential causes fluid to flow in the second tube 358, which is preferably narrow, from the dilation device 350 to the reflux treatment device 399. The flow rate is determined, among other things, by the pressure differential and the cross-sectional area of the second tube 358. Suitably, the second tube is such that the pressure of the volume filling device 399 and the pressure of the expansion device 350 return to equilibrium 3 hours after the fluid has been injected into the expansion device 350 to provide a feeling of satiety. Dimensioned.

In this embodiment, the function of the second tube 358 is to return fluid from the expansion device 350 to the volume filling device 399. It should be appreciated that this function may also be performed by the pump 354 in the first tube 352, and in this case the second tube 358 may be omitted.

FIG. 51b shows an embodiment similar to that shown in FIG. 51a. Thus, an adjustable volume filling device 310 is provided that is recessed into the stomach wall of the patient's stomach 312. Additionally, an adjustable expansion device 350 with the functionality described above is invaginated in the wall of the patient's gastric fundus. The volume filling device 310 is preferably substantially larger than the expansion device 350.

The volume filling device 310 and the expansion device 350 are in fluid communication with each other via a first tube 352 and preferably a second tube having a smaller cross-sectional area than the first tube. However, as an alternative to the pump, a check valve 360 is provided in the first tube 352 instead of the energized pump. This check valve 360 allows fluid to flow in the direction from the volume filling device 310 to the expansion device 10 and not vice versa. This means that this embodiment is not activated at all. Instead, this embodiment operates according to the following principles.

When the hood cavity of stomach 312 is substantially empty, the internal pressure of volume filling device 310 and the internal pressure of expansion device 350 are in equilibrium. In this state, the expansion device is in the non-expansion state. That is, the dilation device does not dilate a portion of the wall of the gastric fundus and thus does not provide a feeling of fullness.

As the patient begins to eat, food enters the food cavity of stomach 312. This will increase the pressure on the stomach wall in which the volume filling device 310 is invaginated and increase the internal pressure therein. In addition, contraction of the stomach wall muscles initiates the processing of food in the food cavity, which further increases the internal pressure of the volume filling device 310.

Since the expansion device 350 is located in the upper portion of the stomach 312 where food does not affect the pressure on the stomach wall, the internal pressure of the expansion device 350 does not change substantially, so the first tube 352 and the second tube 358. Through which fluid flows in the direction from the volume filling device 310 to the expansion device 350. This increases the volume of the expansion device 350 and expands the wall of the fundus of the stomach to give the patient a feeling of fullness.

Fluid flow from the expansion device 350 to the volume filling device 310 through the second tube 358 causes the pressure in these devices to return to equilibrium as described above with reference to Figure 51a.

Similarly, FIG. 51c illustrates an embodiment in which the expansion device 350 may be actively adjusted by manually pressing a conditioning reservoir that is placed subcutaneously under the patient's skin. Therefore, a regulated reservoir 317 for fluid is connected to the inflatable device by a conduit 318 in the form of a tube. Accordingly, the expansion device 350 is adapted to be adjusted non-invasively by moving liquid or air from the adjustment reservoir 317 to the chamber formed by the inflatable device. The coordinator of expansion device 350 may preferably include a reburst servo. That is, a small volume is actuated, for example by the patient's finger, and this small volume is connected to the large volume.

The volume filling device 310 is preferably essentially round in shape so as not to damage the stomach wall. One example of this is shown in Figure 51-3a, where the volume filling device is substantially oval. In another preferred embodiment, the volume filling device is slightly bent, such as the embodiment shown in Figures 51-3b. However, because the stomach wall is rigid, many other shapes, forms and dimensions can be adopted. In one embodiment, the volume filling device has a diameter of about 40 millimeters and a length of about 120 millimeters, and thus has a volume of about half the volume of the patient's stomach. However, the maximum perimeter of the volume filling device is preferably at least 30 millimeters, preferably at least 50 millimeters, more preferably at least 80 millimeters.

It is not essential that the volume filling device be elongated in shape. In the embodiment shown in FIGS. 51-3c, the volume filling device 310 is essentially spherical or ball-shaped. Two or more such volume filling devices may be combined to fill the stomach, thereby reducing the hood cavity of the patient's stomach by as much as desired.

It is mentioned that the volume filling device is anchored by a gastro-gastric suture or staples. To further improve this anchorage, the volume filling device may be provided with a waist portion having a diameter smaller than the maximum diameter of the volume filling device. Such a volume filling device having a waist portion 10a is shown in Figures 51-3d.

The volume filling device 10 may be composed of at least two interconnectable parts, which allows each part to be more easily inserted into the stomach and to pass through a hole in the stomach wall. Thus, Figures 51-3e show a volume filling device including two semi-spherical sub-portions 310b, 310c, preferably interconnected by a small diameter portion. The small diameter portion may have interconnection means with a reversible function to allow later separation of the two interconnected sub-portions 310b, 310c. These means, shown in the figure at 310d, may include plug-in sockets or screw-type connections and the like. Alternatively, the smaller diameter portion may have sub-portions 310b, 310c.
May have a fixed interconnect, such as a resilient locking hook, that engages the rim of a hole in one of the sub-portions 310b, 310c. ..

The configuration of the volume filling device 10 is not limited to one waist portion 310a. Thus, in Figures 51-3f, a volume fill portion is shown with two waist portions.

Attachment means, in the form of a handle or the like, may be provided on the outer surface of the volume filling device to facilitate positioning of the volume filling device. One such example is shown in Figures 51-3g, where a detailed view of the handle 51-10e is also shown. In the preferred embodiment, the attachment means are provided at the end portion of the volume filling device 310. To prevent a portion of the surface of the volume filling device 310 from protruding, a handle 310e is provided flush with the outer surface of the volume filling device 310, and a gripping tool or device (not shown in FIGS. 51-3g). A recess 310f is arranged to allow the )to be gripped tightly around the handle 310e.

The volume filling device may have a tube for filling the volume filling device with a fluid or gel or for emptying the volume filling device. Injecting a fluid or gel into the volume filling device 310 causes the volume filling device to expand to an expanded state, as described below. Also, the size of the volume filling device can be adjusted by moving the fluid or gel from it to another reservoir.

A volume filling device 310 thus adapted is shown in Figures 51-3h. A tube 310g is fixedly attached to the volume filling device. The tube may be attached to a suitable instrument (not shown) or injection port, which will be described in detail below.

Instead of having a fixed mounted tube, the volume filling device 310 can have an inlet port 10h adapted to connect a separate tube (not shown in this figure).

It is important that the implanted volume filling device be firmly maintained in place within the invaginated gastric wall. To this end, the volume filling device may be provided with one or more through holes adapted to receive sutures or staples used to secure the invagination. Such an embodiment is shown in Figures 51-3a to 3i, where the volume filling device 310 comprises a row of holes 10i provided on a protruding flange-like protrusion on the volume filling device. In this embodiment, this row of holes extends along the longitudinal axis of the volume filling device.

(Method of placing the reflux treatment device inside the stomach wall)
The following describes methods and devices for placing a reflux treatment device inside the stomach wall.

The invagination device shown in Figures 52a-l, generally designated 630, has an elongated tubular member 632 similar to the elongated member 607 described above with reference to Figures 48a-i. Accordingly, the invagination device may be connected to the control unit 606 as seen in Figure 48a. The lancing device 630 further comprises a suction portion 634, preferably elongate in shape, provided with a through hole. The suction portion 634 has a plurality of small holes 636 in which air is sucked into the holes by creating a suction action within the tube member 632. This suction action is used to create a "pocket" or "bag" in the portion of the stomach wall generally designated 12a.

In other words, as seen in FIG. 52a, when the tip of the suction portion 634 is pressed against the stomach wall 12a, a small recess is formed in the stomach wall. As the suction portion 634 is further pressed against the stomach wall 12a, as seen in Figure 52b, a larger recess is formed. The portion of the stomach wall 12a forming this recess is brought into close contact with the suction portion 634 of the invagination device 630 by the suction action. As seen in FIG. 52c, deeper depressions are formed when the suction portion 634 is pressed further into the stomach wall 12a, and eventually the entire suction portion 634 is embedded in the depression as seen in FIG. 18d.

At this stage, the rim of the recess has been secured by the securing element 638 and the suction portion has been removed from the instrument, as seen in Figure 52e. 52f, the compressed elastic reflux treatment device 10 is then inserted into this recess, for example in the manner described above with reference to FIG. 47d. The compressed reflux treatment device is then expanded to its final shape, as seen in Figure 52h, and the bag is closed by suturing or stapling with a securing element, as seen in Figure 52i.

All the alternatives described above with reference to Figures 1 to 51 also apply to the embodiment described with reference to Figures 52a-l, i.e. where the reflux treatment device is invaginated inside the stomach wall. Applicable.

53a-c show an instrument for making an invaginated portion of the wall of the stomach, which instrument, depending on whether the reflux treatment device is placed either inside or outside the wall. It may be placed either outside the wall or inside the wall of the stomach. This device uses a vacuum to draw a portion of the wall of the stomach into the cup of the device.

A method has been described in which the reflux treatment device 10 is invaginated in the stomach wall by a gastroscopy instrument. The gastroscopy instrument can be used to place the reflux treatment device either outside the stomach wall as shown in FIG. 1A or inside the stomach as shown in FIG. 2A. In the latter case, the device is used to make an incision in the stomach wall from inside the stomach.

It should be appreciated that open surgical techniques may be used. Next, this method will be described with reference to FIGS. In FIG. 54, a method of reaching the stomach by making an incision 380 in the abdomen of the patient is shown. In FIG. 55, a method in which the device 381 is inserted into the abdomen of the patient is shown. Any of the described instruments and methods can be selected to suit this purpose. Thus, for example, the reflux treatment device may be located outside the stomach as shown in FIG. 1A or inside as shown in FIG. 2A. In the latter case, an incision is made in the wall of the stomach.

(Detailed explanation of stimulation)
FIG. 56 schematically illustrates one embodiment of a device for heartburn and reflux disease according to the present invention, some of which are implanted in the patient and the rest of which is external to the patient's body. ing. Thus, in FIG. 56, all parts located to the right of the patient's skin 2x are implanted into the patient and all parts located to the left of the skin 2x are located outside the patient's body. The apparatus of Figure 56 has an implanted electrostimulation device 4 that is engaged with the cardia sphincter of a patient to form an electrical connection. The implanted control unit 6x controls the stimulation device 4x via the control line 8x. The extracorporeal control unit 10x has an extracorporeal energy source and a wireless remote control device for transmitting control signals produced by the extracorporeal energy source. The control signal is received by a signal receiver incorporated in the implanted control unit 6x, whereby the control unit 6x controls the implanted stimulation device 4x in response to the control signal. The implanted control unit 6x also uses the electrical energy derived from the control signal to power the stimulation device 4x via the power supply line 12x.

57 shows an embodiment of the invention that is the same as the embodiment of FIG. 56, except that instead of an extracorporeal energy source, an implanted energy internal power source in the form of a battery 42x is used. .. Therefore, in this embodiment, an extracorporeal control unit 40x without any energy source is used. In response to the control signal from the extracorporeal control unit 40x, the implanted control unit 6x uses energy from the battery 42x to power the stimulation device 4x.

FIG. 58 illustrates one embodiment of the present invention having a stimulation device 4x, an extracorporeal control unit 10x, an implanted energy source 236x and an implanted switch 238x. The switch 238x is an extracorporeal control unit for switching between an off mode in which the implanted energy source 236x is not used and an on mode in which the implanted energy source 236x provides energy for powering the stimulation device 4x. It is powered by wireless energy released from a 6x extracorporeal energy source.

FIG. 59 shows an embodiment of the invention that is the same as the embodiment of FIG. 58, except that the control unit 6x is further implanted to receive control signals from the wireless remote control of the extracorporeal control unit 10x. .. The switch 238x is an off mode in which the wireless remote control of the implanted energy source 236x and the extracorporeal control unit 10x is not used, ie the control unit 6x cannot receive control signals, and the wireless remote control causes the stimulation device 4x. Wireless energy from an extracorporeal energy source 10x to switch to and from a standby mode, which allows the internal energy source 236x to be controlled to provide energy for powering through the implanted control unit 6x. Operated by.

FIG. 60 shows that an energy conversion device for converting wireless energy into storable energy can be incorporated into the implanted control unit 6x and the implanted energy source 236x can store the storable energy. 59 illustrates an embodiment of the present invention that is the same as the embodiment of FIG. 59 except for the type. In this case, in response to the control signal from the extracorporeal control unit 10x, the implanted control unit 6 will move the energy source 36x to the power of the stimulation device 59x from an off mode in which the implanted energy source 236x is not used. Switch 238x is controlled to switch to an on mode that provides energy for

61 is the embodiment of FIG. 60 except that an energy storage device 240x is further implanted in the patient to store storable energy converted from wireless energy by the conversion device of the control unit 6x. 2 illustrates the same embodiment of the invention as In this case, the implanted control unit 6x has an off mode in which the implanted energy source 236x is not used and an on mode in which the implanted energy source 236x provides energy for powering the stimulation device 4x. The energy storage device 240 is controlled to actuate the switch 238x to switch the energy storage device 240.

FIG. 62 schematically illustrates possible combinations of implanted components of the device for implementing various communication means. Basically, there is an implanted stimulation device 4x, an implanted control unit 6x, and an extracorporeal control unit 10x that includes an extracorporeal energy source and a wireless remote controller. As already explained above, the remote control device transmits a control signal produced by a source of energy outside the body, which control signal is received by a signal receiver incorporated in the implanted control unit 6x, which Thereby, the control unit 6x controls the implanted stimulation device 4x in response to the control signal.

A sensor 54x for sensing a physical parameter of the patient, such as pressure in the esophagus, may be implanted in the patient. The control unit 6x or, alternatively, the extracorporeal control unit 10x can control the stimulation device 4x in response to a signal from the sensor 54x. A transceiver may be associated with the sensor 54x to send information regarding the sensed physical parameter to the extracorporeal control unit 10x. The wireless remote controller of the extracorporeal control unit 10x may have a signal transmitter or transceiver and the implanted control unit 6x may have a signal receiver or transceiver. Alternatively, the wireless remote control of the extracorporeal control unit 10x may have a signal receiver or transceiver and the implanted control unit 6x may have a signal transmitter or transceiver. The transceivers, transmitters and receivers described above may be used to send information or data related to the stimulation device from inside the patient's body to the outside. For example, the battery 32x may be equipped with a transceiver to send information regarding the filling status of the battery.

Those skilled in the art will appreciate that the various embodiments described above according to FIGS. 56-61 can be combined in many different ways.

FIG. 63 illustrates how any of the above-described embodiments of the present invention apparatus for treating heartburn and reflux disease can be implanted in a patient. Thus, the assembly of the device implanted in the patient has a stimulation device in the form of a band 56x wrapped around the cardia 58x. Band 58x comprises a conductor electrically contacting the cardiac sphincter and an operating device 60x for operating stimulation device 56x. An implanted control unit 60x is provided to control the supply of electricity to the band 56x. There is an implanted energy conversion device 62x for converting wireless energy into electrical energy. The conversion device 62x further comprises a signal receiver. The extracorporeal control unit 64x has a signal transmitter for transmitting control signals to the signal receiver of the implanted conversion device 62x. The conversion device 62x can convert signal energy from the control signal into electrical energy for powering the stimulation device 60x and for energizing another implanted energy consuming element of the device.

FIG. 64 shows the basic part of the wireless remote control of the device of the present invention including the implanted electrical stimulation device 4x. In this case, the remote control is based on transmitting an electromagnetic wave signal, often at high frequencies on the order of 100 kHz to 1 GHz, through the skin 130x of the patient. In FIG. 64, all parts located on the left side of skin 130x are located outside the patient and all parts located on the right side of skin 130x are implanted. Any suitable remote control system may be used.

The extracorporeal signal conversion antenna 132x is located close to the signal receiving antenna 134x that is implanted close to the skin 130x. Alternatively, the receive antenna 134x may be located, for example, inside the patient's abdomen. The receiving antenna 134x has a coil of about 1 mm to 100 mm in diameter, preferably 25 mm, wound with very fine wire, which is tuned to a specific high frequency by a capacitor. The smaller coil is selected when implanted under the patient's skin and the larger coil is selected when implanted in the patient's abdomen. The transmit antenna 132x has a coil that is about the same size as the coil of the receive antenna 134x, but is wrapped with a thick wire that can handle the larger current required. The coil of the transmitting antenna 132x is adjusted to the same specific high frequency as the coil of the receiving antenna 134x.

The extracorporeal control unit 136x includes a microprocessor, a high frequency electromagnetic wave signal generator, and a power amplifier. The microprocessor of the control unit 136x turns on/off the generator to modulate the signal produced by the generator to send digital information to the implanted control unit 138x via the power amplifier and antennas 132x, 134x. Adapted to switch off. A digital signal code is used to prevent accidental irregular high frequency fields from inducing control commands. A conventional keypad located on the extracorporeal control unit 136x is connected to the microprocessor of the extracorporeal control unit 136x. The keypad is used to instruct the microprocessor to send a digital signal that either powers or does not power the stimulation device. The microprocessor initiates the command by applying a high frequency signal to antenna 132x. When the signal activates the implanted part of the control system for a short time, a command is sent to power the stimulation device. The command is sent as a digital packet in the form shown below.

The command may be sent continuously for a reasonably long time. When a new powered or unpowered step is desired, the count byte is incremented by 1 and the implanted control unit 138x is able to perform decoding, which is then controlled by the extracorporeal control unit 136x. You will be able to recognize that the steps are required. If any part of the digital packet is abnormal, its content is simply ignored.

The implanted biasing unit 126x extracts energy from the high frequency electromagnetic wave signal received by the receiving antenna 134x via line 140x. The biasing unit 126 stores energy in a power supply, such as a large capacitor, powers the control unit 138x, and further powers the electrostimulation device 4x via line 142x.

The control unit 138x has a demodulator and a microprocessor. The demodulator demodulates the digital signal sent from the extracorporeal control unit 136x. The microprocessor of the control unit 138x receives the digital packet, decodes it, and powers the stimulation device 4x via line 144x if the power supply of the activation unit 126x has stored sufficient energy.

Alternatively, the energy stored in the power supply of the activation unit may only be used to power the switch, and the energy for powering the stimulation device 4x may be of a relatively high capacity, for example a battery. May be obtained from a separate, larger source of power. In this case, the switch is adapted to connect the battery to the control unit 138x in an on mode in which the switch is powered by a power supply and further controls the battery in a standby mode in which the switch is unpowered. Adapted to keep disconnected from the unit.

(Detailed description of expansion)
In the following, two embodiments of the present invention will be described in detail as treatment of reflux can be combined with treatment of obesity. First, an embodiment is shown in which an expansion device is found.

Invagination of the stomach wall is to be understood as the object being placed inside the cavity created by the substance of the stomach wall. The invagination allows for gastro-gastric suturing or stapling, which allows the body tissue to heal and enclose the object.

FIG. 65 shows a first embodiment of the obesity treatment device. The device has an expansion device 10y that is implanted in a patient. In FIG. 65, the expansion device 10y is invaded in the wall 12y of the patient's stomach 12y, and the main body of the expansion device 10y is shaped so as to be stationary facing the wall 12y of the stomach 12y. It has an outer surface suitable for resting facing 12y. This means that the expansion device 10y is preferably essentially round in shape so as not to damage the stomach wall. However, since the stomach wall 12y is strong, many other shapes and forms may be adopted.

The expansion device 10y can be secured to the wall 12ay of the stomach 12y in many different ways. In the embodiment shown in FIG. 65, the expansion device 10y is invaginated in the stomach wall 12ay. After invagination, multiple stomach-gastric-sutures or staples 14y are applied to maintain the invagination for a short period of time. This allows human tissue to grow to maintain the invagination for an extended period of time.

By increasing the size of the expansion device, the circumference of the expansion device 10y is increased and the stomach wall 12y surrounding the expansion device 10y is expanded. This expansion of the stomach wall indicates that the stomach is filled with receptors within the stomach wall, which gives the patient a feeling of fullness. Thus, when the expansion device 10y is contracted, the receptor indicates that the stomach is not full, which restores the feeling of hunger.

Expansion and contraction of expansion device 10y may be performed under direct patient control. Alternatively, expansion and contraction may occur according to a pre-programmed schedule.

Referring again to FIG. 65, this figure further illustrates a fluid manipulation device, ie, a hydraulic or pneumatic manipulation device, suitable for manipulating the expansion device, which is described in detail below.

The expansion device 10y forms a fluid chamber in which fluid can flow. The expansion device 10y thus forms an expandable chamber in which the volume it occupies in the stomach wall can be varied, thereby resulting in a hydraulically or pneumatically controlled expansion device 10y. ..

A regulated reservoir 16y for fluid is connected to the dilation device 10y by a conduit 18y in the form of a tube. Accordingly, the expansion device 10y is preferably adapted to be adjusted non-invasively by moving liquid or air from the conditioning reservoir 16y to the chamber formed by the expansion device.

The regulation reservoir 16y can be regulated in several ways. In the embodiment shown in FIG. 65, the adjustment reservoir 16y is adjusted by manually pressing on the adjustment reservoir 16y. That is, the regulation reservoir 16y is regulated by moving the walls of the reservoir. In this case, the regulation reservoir 16y is preferably placed subcutaneously, which allows non-invasive regulation.

When the conditioned reservoir 16y is pressed, its volume is reduced and hydraulic fluid is transferred from the reservoir via conduit 18 to the chamber formed by the dilation device 10y, expanding or dilating the dilation device 10y. An injection port 1001y may further be provided for filling and for calibrating the fluid level of the device. The injection port preferably comprises a self-sealing member such as a silicone membrane.

Instead of hydraulic operation, pneumatic operation may be employed, in which air instead of hydraulic fluid is moved between the reservoir 16y and the chamber formed by the expansion device 10y. I want you to understand. Suitably, the reservoir has a fixed position for maintaining the reservoir in the desired position. When the patient compresses reservoir 16y, reservoir 16y preferably remains compressed and is released by being pressed again.

Any type of hydraulic solution may be employed for the expansion device. The hydraulic solution may be mechanically driven or powered by any motor or pump or even manually.

FIG. 65 further illustrates a reburst servo system including a conditioning reservoir 16y and a servo reservoir 90y. Servo reservoir 90y hydraulically controls expansion device 10y via conduit 18y. The reverse servo function is described in more detail in Figures 97-100.

FIG. 66a shows a device according to another embodiment in which the motor 40y is adapted to move the wall of the regulation reservoir 16y. Here, the powered regulation reservoir 16y is preferably located in the abdomen of the patient. In this embodiment, a wireless extracorporeal remote control unit 34by, cy and an extracorporeal energy transfer device 34ay may be provided for non-invasively adjusting the motor via the energy conversion device 30y, the energy conversion device 30y comprising: In this embodiment, the motor 40y is adapted to supply energy to an energy-consuming operating device.

The remote control may include a wireless energy transmitter 34ay that may also function as a conditioning device for non-invasively adjusting the expansion device. An internal power source 70y is provided for powering the adjustment device when the adjustment is made by the remote controller 34y. The internal energy source 70y may be, for example, an implantable rechargeable battery or capacitor, or it may be a device for receiving wireless energy transmitted from outside the patient's body. In the following, several techniques for adjusting the expansion device 10y will be described with reference to FIGS.

The device shown in FIG. 66a further comprises a sensor 201y for sensing a patient or, preferably, a device parameter associated with feeding the patient's food. The sensor is connected to the control assembly 42y by a sensor signal transmitting member 202y. This sensor can be used to control the device fully automatically. That is, the device acts on the control assembly to actuate the dilation device 10y to open the stomach wall 12y in response to a sensor signal related to the patient eating, thereby providing the patient with a feeling of fullness. The sensor is adapted to measure contact of the patient with food via any of body temperature, blood pressure, blood flow, heartbeat, respiration and pressure and is connected to the stomach 12y, the esophagus 203y or the cardia 204y. May be arranged. According to one embodiment, the sensor is a strain gauge that measures contraction and/or relaxation of the cardia 204y.

The device shown in FIG. 66a further comprises a second conduit 222y for backflowing hydraulic fluid. The regurgitation is adapted to create the desired feeling of satiety at a given time, and then when the dilatation device flows back a sufficient amount of hydraulic fluid to prevent the gastric wall from expanding further. , The patient recovers hunger. A suitable time for this process is between 1 and 6 hours. According to another embodiment, the reverse flow is performed in the main conduit 18y by a valve system connected to said conduit 18y.

An injection port 1001y is further provided for filling and for fluid level calibration of the device. The injection port 1001y preferably comprises a self-sealing membrane such as a silicone membrane.

FIG. 66b shows the device according to the embodiment of FIG. 66a in a second state in which the expansion device 10y has been expanded, thereby expanding the stomach wall 12y.

67a shows an embodiment in which two expansion devices 10"y are provided. Both expansion devices 10"y operate according to the principles described above with reference to FIG. They may be adapted to be non-invasively adjusted post-operatively, and further have a first portion of the stomach wall widened at a first time and a second portion of the stomach wall widened at a second time, and so on. Sometimes it may be adapted to adjust multiple expansion devices.

Such expansion device 10y may be used to maintain electronics and/or energy sources and/or hydraulic fluids. Hydraulic fluid from this device is distributed over the area of multiple smaller dilation devices to change the dilation area over time to prevent any possibility of more permanent dilation of the stomach wall. You can Multiple mechanical expansion areas may be used. The embodiment according to Fig. 67a further comprises a hydraulic valve shift device 54y implanted in the patient for switching the operation of the first and second dilation devices 10"y. Within the gastric wall to be stimulated. This switching results in a more sustainable device, as the receptors take a long time to recover each time they are expanded.

In Figure 67a, the system is a patient controlled manual system as described above with reference to Figure 65, while in Figure 67b the system is wireless as described above with reference to Figure 66a. -Being energized using energy.

68a-e show multiple embodiments of a dilation device 10y adapted to be implanted in a patient. The expansion device 10y has a surface adapted to contact the stomach wall 12y when the device is invaginated into the stomach wall. FIG. 68b illustrates one embodiment of an expansion device such that the expansion device has a fixation member 206y for suturing or stapling the expansion device to the stomach wall. The fixation member 206y may have a hole for receiving the suture or staple 14y, or the fixation member 206y may be pierceable to allow the suture or staple to penetrate the stomach wall and the fixation member 206y. May be. FIG. 68c shows expansion device 10y according to an embodiment such that expansion device 10y has an inlet member 207y for filling the device with fluid. The inlet member is preferably connected to a hydraulic conduit 18y adapted to be recessed in the stomach wall 12y. FIG. 68d shows an expansion device 10y according to an embodiment such that the expansion device 10y has a retaining member 208 adapted to be connected to the insertion device when the expansion device 10y is inserted into the invagination bag of the gastric wall 12y. 10y is shown. FIG. 68e illustrates an expansion device 10y according to an embodiment in which the expansion device is slightly oval or oval. Figure 68e further shows the hydraulic conduit 18 attached to the expansion device 10y. FIG. 68f illustrates expansion device 10y, according to an embodiment such that the expansion device is expandable by the fluid being transported through conduit 18y. According to one embodiment shown in FIG. 68f, the conduit has two sections 18ay, by, the first section 18ay being adapted to pull the expansion device 10y into place with a fluid that is also suitable for pulling the device 10y. The second section 18by is used to fill, while the second section 18by is used to activate the device 10y. Figure 68g shows the expansion device 10y according to the embodiment of Figure 68f in a deflated state.
Is shown. The expansion device 10y is inserted deflated through a hole in the stomach wall 12y, after which the device 10y is filled with a suitable fluid to be actuated. FIG. 68h illustrates an expansion device 10y according to one embodiment, where the expansion device 10y has two movable wall portions 223ay, by that can be moved by a bellows structure 209y made of a flexible material. Have. 68i illustrates an expansion device according to one embodiment, where the expansion device has four expansions symmetrically arranged at four positions along the surface of the expansion device as shown in the cross-sectional image of FIG. 68i. It can be expanded by the possible section 210y. These sections 210y are made of a flexible material that allows the sections 210y to expand when the expansion device 10y is filled with hydraulic fluid.

(Surface structure of implant)
69a-k, a schematic structure of an optional implanted device of the present invention will now be described. The present invention relates to an implant adapted to be adjustable post-operatively and having at least one expandable section, wherein the implant is adjustable between a first collapsed state and a second expanded state. Adapted to be. The expandable section is folded in the first folded state, and the expandable section is expanded in the second extended state. The outer surface of the expandable section has, at least in part, a surface structure having high areas alternating with low areas. In the expandable section, in at least one of the first folded state and the second expanded state, adjacent high regions due to the growth of fibrous tissue are adjacent to each other in the first folded state and the second folded state of the plant. It is adapted to have a first distance between adjacent high regions that is sufficiently expanded to prevent direct interconnection to the extent that adjustability to and from the expanded state is compromised. The expandable section further having a connection region between the adjacent high region and low region has an adjacent connection due to growth of fibrous tissue in at least one of the first folded state and the second expanded state. Adjacent connection regions sufficiently expanded to prevent the regions from being directly interconnected to the extent that the adjustability of the implant between the first collapsed state and the second expanded state is compromised. Further adapted to have a second distance between.

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

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

Since fibrous tissue often has a stretch or thickness of about 0.5 mm to about 1.5 mm, the distance between the corresponding surfaces of the surface structure elements is preferably about 3 mm or about 2×1. Greater than 5 mm. However, in some circumstances, a distance of about 1.0 mm to more than about 3 mm may be sufficient. If the fibrous tissue is expected to have a stretch or thickness greater than about 1.5 mm, the distance between the corresponding surfaces of the surface structure elements is appropriately adapted.

The surface structure may have high and low regions, and the distance between the different planes of the high and low regions is also above a certain threshold to assist the implant in its ability to fold and expand. May be appropriate. If the distance is too small, the ability of the implant to collapse and/or expand may be limited. Suitable intervals for the above distances are about 0.5 mm to 10 mm, more preferably about 2 mm to 8 mm, most preferably about 3 mm to 7 mm. The surface structure may include a plurality of geometric elements or shapes and any combination of those elements or shapes, as long as the above distance conditions are met. The surface structure can include, for example, differently shaped ridges and grooves. The ridges and grooves can each have a cross-section, for example wedge-shaped, polygonal, square, pyramidal or truncated pyramidal. Further, the ridges and grooves may have different cross-sectional shapes. The surface structure may generally have a bellows-shaped configuration, or a surface structure in which geometric objects of the same or different kind are arranged on the surface. The geometric objects are arranged on the surface in a substantially random manner or according to some scheme.

One type of implant for which this type of surface structure may be suitable is an implant that has the ability to substantially change shape and/or size. Therefore, this is the case when the presence of fibrous tissue can substantially impede or inhibit the function of the implant. However, the surface structure may be used for any implant if the properties of the surface structure are beneficial to the implant.

The first distance 708a between the two elevated regions 701 seen in FIG. 69a is long enough to prevent the two adjacent elevated regions 707 from being directly connected by the growth of fibrous tissue. That's it. That is, it is conceivable that fibrous tissue may grow on the surfaces of the high region 701, the low region 702 and the connection region 704. However, the expansion of the first distance 708a prevents the fibrous tissue from growing directly from the high region 701 to another adjacent high region 701.

The expression "directly grows from a high region 701 to another high region 701" means, for example, that the fibrous tissue does not grow on the connecting region 704 or grows to a small extent, so that the high region 701 is different from the high region 701. It means growing to the region 701. The first distance 708a may be measured within a distance 704a from the height of the elevated area 701, as shown at 704a in FIG. 69i. The expression "growing directly from a tall region 701 to another adjacent tall region 701" means that the fibrous tissue from each neighboring region fills the distance or space between the two tall regions 701. It also includes the situation of growing on adjacent regions, for example on two adjacent connection regions 704, with a thickness such that they connect. In such a situation, the space between the two raised areas 701 is partially or wholly filled with fibrous tissue.

Advantageously, the second distance 708b corresponding to the expansion of the lower region 702 is sufficiently long to prevent fibrous tissue from growing directly from one connecting region 704 to another connecting region 704. There are cases. The expression "directly grows from the connecting region 704 to another connecting region 704" means that the fibrous tissue grows on the lower region 702 without growing or only to a small extent so that the connecting region 704 makes another connection. It means growing to the region 704.

In FIG. 69i, a surface structure including high and low regions is shown, but different from the high and low regions if it is possible to prevent the growth of fibrous tissue as described above, Many other geometric structures may also be employed. Specifically, as described above, the fibrous tissue is prevented from growing between the high regions and the connecting regions.

Some examples of such alternative geometries are shown in Figures 69i-k. For surface structures with ridges and grooves, the ridges and grooves may have different cross-sections, some examples being shown in Figures 69b-69e.

Next, some surfaces and appearances will be described mainly with reference to FIGS. 69a and 69b. The concept of a first distance 708a, 718a between adjacent high areas 701, 710 is used herein. These first distances 708a, 718a substantially mean the distances measured from the edges 706, 714 of one tall area 701, 710 to the edges 706, 714 of the adjacent tall area 701, 710. To do. Substantially from the edge means that measurements may be made within the first spacing 704a from the height of the high areas 701, 710, which first spacing 704a is high. Adjacent lower area 7 from the height of areas 701 and 710
It extends toward the height of 02, 712.

Also, the concept of second distances 708b, 718b between adjacent connection areas 704, 716 is used herein. These second distances 708b, 718b are measured substantially from the point of connection between the connection areas 704, 716 and the lower areas 702, 712 to another connection point contained in an adjacent connection area 704, 716. Means the distance that is taken. Substantially from the point of connection means that the measurement may be made within the second spacing 704b from the height of the lower areas 702, 712, which second spacing 704b is lower. It extends from the height of 702 towards the height of adjacent high areas 701, 710.

High and low regions mean that these regions lie in different planes 703, 705, 720, 722, which are separated by a distance 707, 724, 728. These planes may be parallel or substantially parallel, but they may also be non-parallel. If the planes are parallel, it is easy to define the distance between them. If the planes are non-parallel (as seen in Figure 2a), the distance between the planes may be defined by perpendiculars 724,728 to one of the planes 720,722, where the perpendiculars are It extends to a point on an area of another plane 722, 726, the distance between these planes being equal to the extension of this perpendicular 724, 728. As can be seen in Figure 2a, the normals 724, 728 extend from the planes 720, 722 to points at approximately equal distances from the edges of the region. There are two possible ways to define the perpendicular or distance between the planes. For example, for perpendicular 728, the perpendicular can be defined as 728a or 728b. It may be appropriate to define the distance between the two planes as the amount of extension of the longest perpendicular, in which case the distance between planes 720 and 722 will be equal to the amount of extension of perpendicular 728a. This definition is adopted below.

The high and low regions may differ in shape, which may be flat or substantially flat, but may also be somewhat curved in shape.

The high areas 701, 710 are connected to the adjacent low areas 702, 712 by connection areas 704, 716. The connection points between the high/low areas and the connection areas 704, 716 may include radii of various sizes, such as large or small radii. If the radius is very small, there are substantially edges 706, 714 connecting the regions.

The expression "extendable section" also means that this section is foldable.

Suitably, implantable device 10 comprises, at least in part, a highly biocompatible material that is physiologically inert, biologically inert, or bioactive. May be considered compatible.

With particular reference to Figures 69a-b, the surface structure 700 may advantageously have a designated first distance 708a, 718a between adjacent elevated regions 701, 710. The distance between adjacent tall regions 701, 710 is selected so that fibrous tissue does not span the first distance 708a, 718a between adjacent tall regions 701, 710. Therefore, the first distances 708a, 718a between adjacent tall regions 701, 710 are advantageously sufficient to prevent formation of fibrous tissue joining the adjacent tall regions 701, 710. Is the length.

As mentioned above, advantageously, there may be a designated second distance 708b, 718b between adjacent connection regions 704, 716. The second distances 708b, 718b between adjacent connecting regions 704, 716 are selected so that fibrous tissue does not bridge the second distance 708b, 718b between adjacent connecting regions 704, 716. Therefore, the second distances 708b, 718b between adjacent connecting regions 704, 716 are advantageously sufficient to prevent the formation of fibrous tissue connecting the adjacent connecting regions 704, 716. Is the length.

Furthermore, a third distance 707, 724, 728a between different planes 703, 705, 720, 722, 726 of the high and low regions is above a certain threshold to assist the folding and/or expanding function of the implant. Larger is advantageous. If the third distance 707, 724, 728a is too small, the folding and/or expanding function of the implant may be limited. A suitable spacing for the third distances 707, 724, 728a is 0.5 mm to 10 mm, more suitably 2 mm to 8 mm, most suitably 3 mm to 7 mm. Further, the distances 707, 724, 728a are not too small, suitably the spacing(s) described above, considering that the fibrous tissue should not interfere with the folding/expanding function of the implantable device. Is advantageous.

The surface structure 700 may have different geometrically shaped objects or elements, such as, for example, differently shaped ridges, differently shaped embossments, and other objects that can provide the surface structure described herein. it can. The areas of the elevated regions 701, 710 may be very small and still provide the surface structure with the desired functionality. The area of the elevated regions 701, 710 may be near zero as illustrated in Figure 2d. 1 and 2a-2d show cross-sectional views of an embodiment of surface structure 700, while FIGS. 69i-k show perspective views of an embodiment of a plurality of surface structures 700. The objects or elements within the surface structure 700 may be organized in some way and arranged in a row, or may be distributed somewhat irregularly over the surface of the implant. Different types of objects may be used together in the surface structure 700, for example, pyramidal and conical objects with some shaped ridge may be combined.

69f-h, one embodiment of the implant 10 is shown, where the surface structure 700 is used, and the implant 10 is not fully shown. FIG. 69f shows a longitudinal cross section of implant 10, where 740 refers to the upper surface structure of implant 10 and 742 refers to the lower surface structure of implant 10. As shown in FIG. 69f, the lower surface structure 742 can have a greater extension than the upper surface structure 740 of the artificial penis. This allows the implant 10 to have a curved upper portion when expanded. Surface structures 140 and 142 are an example of a bend. FIG. 69g shows a cross-sectional view of implant 10, where implant 10 has waist portion 744, which has waist surface structures 746 and 748. The waist portion with waist surface structures 746 and 748 also allows implant 10 to be radially expanded. The implant 10 can also have a cross-section as shown in FIG. 69g, including a waist portion 744 having four waist surface structures 750, 752, 754, 756, which allows the implant 10 to be radially expandable. Is further promoted. The cross-sectional views of Figures 69g and h are taken along line A1-A2 of Figure 69f.

(Another embodiment including an expansion device)
Next, another embodiment of the present invention will be described which discloses a method for treating obesity by opening the stomach.

Figure 70a shows an expansion device 10y with an inlet port 18by. The expansion device 10 is invaginated in the stomach wall 12y and the inlet port 18by may be used to connect a tube or the like from the patient's abdominal region. The tube or conduit 18y may suitably be connected to the control unit 42y or the injection port 1001y.

FIG. 70b shows an invaginated dilation device 10y, where instead of an inlet port, a conduit 18y or electrical lead extends into the patient's abdominal region.

FIG. 70c shows a section of the expansion device 10y and the part of the stomach in which the expansion device 10 is invaginated. The conduit 18y or electrical lead is invaginated by the stomach-gastric suture or staple 14y into the gastric wall 12y, thereby forming a completely sealed bag of gastric wall tissue in which the expansion device 10y is placed. It is arranged. Thus, the conduit 18y or electrical lead has passed through the stomach wall 12y between the inlet port 18by and the volume filling device 10y.

It has been shown that the expansion device 10y can take many different shapes. It should be appreciated that the material of expansion device 10y may also vary. Suitably, expansion device 10y comprises a coating such as a parylene coating, a polytetrafluoroethylene (PTFE) coating or a polyurethane coating, or a combination of these coatings or a multi-layer coating. This coating or multilayer coating improves properties of the expansion device, such as wear resistance.

In another embodiment, shown in FIG. 71, the expansion device 110y operates according to principles that differ from those described above with reference to FIGS. Here, the expansion device 110y includes a first fixation portion 110ay adapted to have a first fixation at a first position on the stomach wall 12y and a second position on the stomach wall 12y. A second fixing portion 110by adapted to have a second fixing portion. These fixation parts 110ay, by, which are preferably essentially round in shape and are preferably adapted to be invaginated in the stomach wall 12y, are attached to the distal end of their respective legs 211y, and Attached to an operating device such as motor 40y at each proximal end. According to the embodiment shown in FIG. 71, the motor is a hydraulic motor including a hydraulic piston, which is connected to the manually operated device described above with reference to FIG. The hydraulic piston acts on the leg via a connection with a joint 212y located at the tip of the leg. The expansion device 110y is surrounded by a housing 214y to protect the device from ingrowth of fibrous tissue that can impair the function of the device 110y. However, it is likewise conceivable that the motor is another hydraulic, pneumatic or electric motor.

The expansion device 110y is adapted to increase the distance between the first position and the second position on the gastric wall 12y, thereby expanding the gastric wall 12y. The first fixation portion 110ay and/or the second fixation portion 110by may be attached to the stomach wall 12y by a stomach-stomach/suture or staple 14y that holds the fixation portion 110ay, by in place in a suspended manner relative to the stomach wall 12. It is adapted to be at least partially invaginated.

Of course, the first and second positions may be sutured or secured to the gastric wall in many possible ways and the present invention allows the two positions of the gastric wall to be moved away from each other thereby first moving the device to the gastric wall. Includes all possibilities for expanding the stomach wall by fixing it in at least two positions. However, it is preferable that the stomach-gastric/fibrous tissue is connected to the stomach wall 12y in such a manner as to be gently suspended so as to facilitate securing a stable position for a long period of time.

Of course, only by expanding the invaginated portion of the stomach wall will the stomach wall 12 be spread apart, which may be achieved mechanically, hydraulically or pneumatically and even powered by a motor or pump. Can be achieved either by being done or by manual force.

Any type of mechanical configuration may be used, and the disclosed mechanical embodiments are examples. Any mechanical configuration that is mechanically or hydraulically driven, or any pneumatic configuration may be used. To achieve the simple task of widening a part of the stomach wall by moving at least two parts of the stomach wall away from each other, any motor, any pump, or a movable material that changes its shape when powered May be used.

72 illustrates an expansion device 110y according to an embodiment in which the expansion device is controlled from an implantable control assembly 42y that receives input from a sensor as described above. In this case, the expansion device is conditioned via conduit 18y using pump 44y connected to at least one fluid reservoir 16y, 46y and is positioned under skin 36y to receive wireless energy receiver 205y or recharge. Powered by an energy conversion member 30y connected to an implantable energy source 70y such as a battery.

In one variation shown in Figure 73a, each of the first fixation portion 210ay and/or the second fixation portion 210by is for long-term fixation in the position where the expansion device 110y attached to the stomach wall 12y is located. It forms a structure adapted to contact the stomach wall 12y to promote ingrowth of human body tissue. This structure preferably includes a net-shaped structure 213y. The fixation portions 210ay, 210by are configured to maintain the expansion device 110y in place by sutures or staples between the fixation portions and the stomach wall 12y, and also to fix the position in which the expansion device 110y is placed for a short period of time. May be adapted. In terms of mechanical operation, the expansion device 110y according to the embodiment shown in Figure 73a functions according to the device described with reference to Figure 71. FIG. 9by shows a fixation device 213y that includes a net-like structure adapted to propagate fibrous tissue ingrowth to secure the two fixation portions to the stomach wall 12y.

73c shows the expansion device according to the embodiment of FIG. 73a in a second state with the two fixation parts separated from each other and the stomach 12y expanded.

Figure 74a illustrates an expansion device, according to one embodiment, such that the expansion device is an electromechanical expansion device connected to the control assembly 42y via a power supply line 32'y. The power supply line 32y is connected to a power conversion device 30y that is in contact with a wireless energy receiver 205y, such as a coil that receives energy from the wireless energy transmitter 34ay. The control assembly may further include a battery 70y for storing the energy received from the wireless energy transfer device 34ay. The control assembly receives input from a sensor 201y, which in this embodiment is a strain gauge that measures contraction and/or relaxation of the cardia 204y.

FIG. 74b shows the expansion device 10y in more detail. The expansion device 10y has a housing with a bellows structure 209y made of a flexible material to allow the wall portion to move. A power supply line 32y is connected to the stator 217y of the electric motor, said motor further having a rotor 218y containing yarns that interact with the displaceable member 219y containing the corresponding yarn. The displacement member is rotatably secured to the housing contact member 220y, which acts on the volume of the dilation device and thereby pushes the housing to open the stomach 12y.

FIG. 74c shows the expansion device according to FIG. 10by in the second state, wherein the expansion device is inflated and thus widens the stomach wall 12y.

Figure 75a illustrates one embodiment in which a device adapted to treat reflux disease is combined with an expansion device according to any of the above embodiments. After the device 410 is invaginated in the base 416, a fixation part consisting of a plurality of stomach-gastric-sutures or staples 422a is applied to maintain the invagination for a short time. A second securement composed of a plurality of sutures or staples 422b is provided to hold the device 410 in place over the cardia 414. Suture or staple 422b is applied between the wall of base 416 and the wall of esophagus 424y. Additionally, a third anchor in the form of a suture or staple 422cy is also provided between the wall of the base 416 and the diaphragm 418 to also hold the device 410 in place above the cardia 414. Good.

In this fourth embodiment, shown in Figure 75a, the size of the reflux disease treatment device 410 may be adjusted when implanted. The reflux disease treatment device 410 is associated with a subcutaneous hydraulic reservoir 452 that is connected to the reflux disease treatment device 410 by a lead 452b, so that manually pushing the reservoir 452 provides non-invasive adjustment. obtain. By pushing the reservoir 452, the hydraulic fluid is displaced from the reservoir 452 to the small chamber 410b via the lead 452b. The reflux disease treatment device 410 is further connected to one or more small chambers 410b. In this way, the patient can adjust the size of the reflux treatment device 410 in a therapeutically compatible manner.

In addition, the above embodiments may alternatively be used to treat obesity. In this embodiment, the device uses the volume of the reflux disease body to contain the fluid, as well as to fill and expand with the fluid, thereby expanding the base wall and providing a feeling of satiety, It is adapted to treat obesity using one or more small chambers 410b connected to the device body by a pump. The small chamber 410b is also adapted to be invaginated in the stomach wall at the base when filled with fluid, and the stomach is inflated to provide fullness due to human sensor feedback. The subcutaneous hydraulic reservoir/pump advantageously allows the patient to expel hydraulic fluid, which fills the small chamber 410b to give the patient a feeling of fullness when desired.

An alternative embodiment is shown in Figure 75b. This embodiment is substantially similar to the embodiment shown in FIG. 75a, but differs in the manner in which reflux treatment device 410 and chamber 410b are controlled. Here, the chamber 410b is controlled by a powered internal control unit 456 rather than a subcutaneous pump. The internal control unit 456 comprises means for the patient to control the device 410 in the manner in which the device 410 is used in treating reflux and/or obesity. The internal control unit 456 also has means for powering the device.

The internal control unit 456 can include a battery 470, an electrical switch 472, a motor/pump 444, a reservoir 452, and an injection port 1001. An energy transfer device 34 with a remote control is adapted to control the device and also to power the device. The item is selected depending on the circumstances such as whether the device is operated electrically, hydraulically, pneumatically or mechanically. The device 410 may be used to maintain electronics and/or energy sources and/or hydraulic fluids.

FIG. 76a shows an adjustable volume filling device 810y that is invaginated in the stomach wall of a patient's stomach 12y. The volume filling device 810y is adapted to occupy space in the stomach and thereby reduce the volume in which food can be placed. Additionally, the adjustable expansion device 10y according to any of the embodiments is invaginated in the wall of the gastric fundus of the patient. Preferably, the volume filling device 810y is substantially larger than the expansion device 10y.

The volume filling device 810y and the expansion device 10y are in fluid communication with each other via a first fluid line 52y in which a pump 54y is provided. Pump 54y is controlled by an energy conversion device 30y adapted to provide energy to pump 54y via power supply line 56. The energy conversion device 30 is further connected to a sensor 201y provided in the esophagus so that it can detect intake of food.

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

The operation of this configuration is as follows. Volume filling device 810y serves as the embodiment described above. That is, the volume filling device 810y reduces the size of the hood cavity of the patient's stomach 12y. Additionally, when expansion device 10y is expanded by the fluid being pumped from volume filling device 810y to expansion device 10y by pump 54y, the walls of the gastric fundus are expanded, giving the patient a feeling of fullness. Thus, for example, when food is sensed by sensor 201y, fluid is automatically pushed into dilation device 10y to enhance satiety and thereby limit food intake.

When the fluid is injected into the expansion device 10y, its internal pressure becomes higher than the internal pressure of the volume filling device 810y. This pressure differential causes fluid to flow in the preferably narrow second tube 58y from the expansion device 10y to the volume filling device 810y. The flow rate is determined, among other things, by the pressure differential and the cross-sectional area of the second tube 58y. Suitably, the second tube is such that the pressure of the volume filling device 810y and the pressure of the expansion device 10y return to an equilibrium state 3 hours after the fluid is injected into the expansion device 10y to give a feeling of satiety. Dimensioned.

In this embodiment, the function of the second tube 58y is to return fluid from the expansion device 10y to the volume filling device 810y. It should be understood that this function may also be performed by the pump 54y in the first tube 52y, and in this case the second tube 58y may be omitted.

Another embodiment of an apparatus for treating obesity will now be described with reference to Figure 76b showing the stomach 12y of a patient being treated for obesity. The device has a volume filling device 810y in the form of an inflatable device 10y that is recessed into the wall 12ay of the patient's stomach 12y. However, in this case, the invagination occurs in the fundus, the upper part of the stomach, where there are many receptors in the stomach wall, and the inflatable device functions as an expansion device for a part of the wall of the stomach fundus. To do.

A regulated reservoir for fluid is connected to the inflatable device by a conduit 18y in the form of a tube. Accordingly, the inflatable device 810y is preferably adapted to be non-invasively conditioned by moving liquid or air from the conditioning reservoir to the chamber formed by the inflatable device 810y. Adjustment of the inflatable device 810y preferably includes a reburst servo, ie, a small volume is actuated, for example by the patient's finger, which is connected to a large volume or adjustment reservoir.

Thus, the inflatable device 810y is located outside the stomach wall and is adapted to widen a portion of the gastric fundus to affect the patient's appetite. Increasing the size of the expansion device increases the circumference of the inflatable expansion device 810y and widens the wall of the gastric fundus surrounding the inflatable expansion device 810y. This unfolding indicates that the receptors in the stomach wall are filling the stomach, which gives the patient a feeling of fullness. Thus, when the expansion device 810y is contracted, the receptor indicates that the stomach is not full, which restores the feeling of hunger. It is to be understood that this embodiment has both the effect of reducing the volume of the hood cavity of the stomach and widening a part of the stomach wall 12y, which improves the therapeutic effect.

Expansion and contraction of expansion device 810y may be performed under direct patient control. Alternatively, expansion and contraction may occur according to a pre-programmed schedule.

In the preferred embodiment shown in Figure 76c, the sensor 210y is provided at a suitable location, such as the esophagus. Volume filling device 810y in the form of an inflatable expansion device is similar to the volume filling device shown in Figure 76b. By providing one or more sensors, the device for treating obesity can be automated and the size of the volume filling device 810y in the form of an inflatable expansion device enters the gastric hood cavity. It is adjusted according to the amount of food. Thereby, fluid is moved between the inflatable volume filling device 810y and the fluid reservoir.

(system)
77-93, an obesity treatment system, shown generally at 28, that may be combined with the above-mentioned system for treating reflux, including the expansion device described above, will now be described. This system 28 may be combined with or may be identical to the system 28 for treating reflux of FIGS.

The system of FIG. 77 has an expansion device 10y that is placed on the patient's abdomen. The internal energy source in the form of an implanted energy conversion device 30 is adapted to supply energy to the energy consuming element of the bariatric treatment system via power supply line 32. The extracorporeal energy transfer device 34 has a wireless remote control device for transmitting wireless signals, which may be incorporated into the implanted energy conversion device 30 or separated by a signal receiver. Be received. The implanted energy conversion device 30 converts energy from a signal into electrical energy supplied via a power supply line 32.

The system of FIG. 77 is shown in a more schematic block diagram form in FIG. 79 where the patient's skin 36, shown in generally vertical lines, is in line with the patient's interior to the right of the line. Separated from the outside on the left side.

FIG. 77 shows a simplified block diagram showing the expansion device 10y, the energy conversion device 30 powering the expansion device via the power supply line 32, and the extracorporeal energy transmission device 34.

78 is the same invention as the embodiment of FIG. 81, except that a reversing device in the form of an electrical switch 38 that can be actuated by polarization energy to reverse the expansion device 10y is also implanted in the patient. 2 shows an embodiment of the present invention. A wireless remote control of the extracorporeal energy transfer device 34 transmits a wireless signal carrying polarized energy and the implanted energy conversion device 30 converts the polarized wireless energy into a polarized current for operating an electrical switch 38. .. When the polarity of the current is changed by the implanted energy conversion device 30, the electrical switch 38 reverses the function performed by the expansion device 10y.

79 is similar to FIG. 78 except that a manipulation device 40 for implanting the expansion device 10y, which is implanted in the patient, is provided between the implanted energy conversion device 30 and the expansion device 10y. 3 shows the same embodiment of the invention. This operating device may be in the form of a motor 40, such as an electric servomotor. The motor 40 is powered by energy from the implanted energy conversion device 30 as the remote control of the extracorporeal energy transmission device 34 transmits a wireless signal to the receiver of the implanted energy conversion device 30.

80 is similar to the embodiment of FIG. 81 except that it further includes a manipulation device in the form of an assembly 42 that includes a motor/pump unit 78 and a fluid reservoir 46 that is implanted in a patient. The embodiment is shown. In this case, the expansion device 10y is hydraulically operated. That is, hydraulic fluid is urged by the motor/pump unit 44 from the fluid reservoir 46 via conduit 48 to the expansion device 10y to operate the expansion device, and the hydraulic fluid also causes the expansion device to start at the starting position. Motor/pump unit 44 to push back from expansion device 10y back to fluid reservoir 46. Implanted energy conversion device 30 converts wireless energy into electrical current, eg, polarization current, for powering motor/pump unit 44 via power supply line 50.

Instead of the hydraulically operated expansion device 10y, it may be envisaged that the operating device comprises a pneumatic operating device. In this case, pressurized air may be used for conditioning, the fluid reservoir is replaced by an air chamber and the fluid is replaced by air.

In all of these embodiments, the energy conversion device 30 may have a rechargeable accumulator in the form of a battery or capacitor that is charged by wireless energy to provide energy to any energy consuming part of the device. be able to.

The extracorporeal energy transmission device 34 is preferably wireless and may have a remotely controlled control device for controlling the device from outside the human body.

Such control devices include wireless remote controls as well as manual control of the part to be implanted which is most likely indirectly contacted by the patient's hand, for example with a push button located under the skin. A device may be included.

FIG. 81 illustrates one embodiment of the invention having an extracorporeal energy transmission device 34 with a wireless remote control, a hydraulically operated expansion device 10y, and an energy conversion device 30 to be implanted. However, this embodiment further comprises a hydraulic fluid reservoir 52, a motor/pump unit 44, and a reversing device in the form of a hydraulic valve shift device 54, all of which are implanted in the patient. It Of course, the hydraulic valve may be omitted since hydraulic operation can be easily performed by simply changing the direction of the pump. The remote control may be a device separate from the extracorporeal energy transmission device or may be included in the extracorporeal energy transmission device. The motor of motor/pump unit 44 is an electric motor. In response to a control signal from the wireless remote control of the extracorporeal energy transfer device 34, the implanted energy conversion device 30 powers the motor/pump unit 44 with the energy carried by the control signal to drive the motor. /Pump unit 44 distributes hydraulic fluid between hydraulic fluid reservoir 52 and expansion device 10y. One direction in which the motor/pump unit 44 pushes fluid from the hydraulic fluid reservoir 52 to the expansion device 10y, thereby operating the expansion device, and the motor/pump unit 44 from the expansion device 10y to the hydraulic fluid reservoir 52. The remote control of the extracorporeal energy transfer device 34 to switch the flow direction of the hydraulic fluid to and from the opposite direction in which the fluid is pushed back to and thereby the expansion device is returned to the starting position. Control the shift device 54.

82 is the embodiment of FIG. 81 except that an internal control unit 56 controlled by the wireless remote control of the extracorporeal energy transmission device 34, an accumulator 58, and a capacitor 60 are also implanted in the patient. 2 illustrates an embodiment of the present invention that is the same as The internal control unit 56 is configured to store electrical energy received from the implanted energy conversion device 30 within the accumulator 58, which provides energy to the expansion device 10y. In response to a control signal from the wireless remote control of the extracorporeal energy transfer device 34, the internal control unit 56 releases electrical energy from the accumulator 58 to power the extended energy to operate the expansion device 10y. Electric energy from the energy conversion device 30 that is either converted via lines 62 and 64 or is implanted is transferred via power line 66, current stabilizing capacitor 60, and power line 68 and power line 64. Convert directly.

The internal control unit is preferably programmable from outside the patient's body. In a preferred embodiment, the internal control unit adjusts the dilation device 10y to open the stomach according to a pre-programmed time schedule, or any possible physical parameter or device of the patient. It is programmed to come from any sensor that senses a functional parameter.

According to one alternative, the capacitor 60 of the embodiment of Figure 18 may be omitted. According to another alternative, the accumulator 58 of this embodiment may be omitted.

83 is the embodiment of FIG. 77 except that a battery 70 that provides energy to operate the expansion device 10y and an electrical switch 72 to switch the operation of the expansion device 10y are further implanted in the patient. 2 illustrates the same embodiment of the invention as The energy provided by the implanted energy conversion device 30 is an electrical switch 72 for switching from an off mode in which the battery 70 is not used to an on mode in which the battery 70 supplies energy to operate the expansion device 10y. Operated by.

84 illustrates an embodiment of the invention that is the same as the embodiment of FIG. 83 except that an internal control unit 56, which is controllable by the wireless remote control of the extracorporeal energy transfer device 34, is also implanted in the patient. Showing. In this case, the wireless remote controller is prevented from controlling the internal control unit 56 and the remote controller is operated from the off mode where the battery is not used to release electrical energy from the battery 70 to operate the expansion device 10y. The electrical switch 72 is operated by the energy provided by the implanted energy conversion device 30 to switch to a standby mode that allows the internal control unit 56 to be controlled.

FIG. 85 shows an embodiment of the invention that is the same as the embodiment of FIG. 84, except that the accumulator 58 is used in place of the battery 70 and the implanted components are individually interconnected. In this case, the accumulator 58 stores energy from the implanted energy conversion device 30. In response to a control signal from the wireless remote control of the extracorporeal energy transfer device 34, the internal control unit 56 controls the electrical switch 72, thereby actuating the expansion device 10y from the off mode where the accumulator 58 is not used. For this purpose, the accumulator 58 is switched to the on mode in which it supplies energy.

86 illustrates an embodiment of the invention that is the same as the embodiment of FIG. 85, except that the battery 70 is further implanted in the patient and the further implanted components are individually interconnected. In response to a control signal from the wireless remote control of the extracorporeal energy transfer device 34, the internal control unit 56 controls the accumulator 58 to provide energy to actuate the electrical switch 72, thereby causing the battery 70. Is switched off from an off mode where it is not used to an on mode in which the battery 70 supplies electrical energy to operate the expansion device 10y.

Alternatively, the wireless remote controller may be activated by the wireless remote controller to operate the expansion device 10y from an off mode that is prevented and not used to control the battery 70 to supply electrical energy. The electrical switch 72 may be operated by the energy provided by the accumulator 58 to switch to a standby mode that allows the battery 70 to be controlled to provide energy.

It should be appreciated that the switch should be construed in its broadest embodiment. This means that the FPGA or DA converter or any other electronics or electronics can be switched off or on, preferably while being controlled from outside the patient's body or by an internal control unit. ..

87 of FIG. 83, except that the motor 40, a mechanical reversing device in the form of a gear box 74, and an internal control unit 56 for controlling the gear box 74 are further implanted in the patient. 3 illustrates an embodiment of the invention that is the same as the embodiment. The internal control unit 56 controls the gear box 74 (mechanically operated) to reverse the function performed by the expansion device 10y. A simpler form is to electronically switch the direction of the motor.

88 illustrates an embodiment of the invention that is the same as the embodiment of FIG. 86, except that the components to be implanted are individually interconnected. Thus, in this case, the internal control unit 56 is powered by the battery 70 when the accumulator 58, preferably the capacitor, activates the electrical switch 72 to switch to the on mode. When the electrical switch 72 is in the on mode, the internal control unit 56 will be able to control the battery 70 to provide or not provide energy to operate the expansion device 10y.

FIG. 89 schematically illustrates possible combinations of implanted components of the device for implementing various communication options. Basically, there is an expansion device 10yy, an internal control unit 56, a motor or pump unit 44, and an external energy transfer device 34 that includes an external wireless remote control device. As previously described above, the wireless remote control device transmits control signals received by the internal control unit 56 to control various implanted components of the device.

A feedback device, preferably in the form of a sensor 76, may be implanted in the patient to sense a physical parameter of the patient, such as a contraction wave in the esophagus 203 that signals that the patient is eating. .. An internal control unit 56, or alternatively an external wireless remote control of the external energy transmission device 34, can control the expansion device 10y in response to a signal from the sensor 76. A transceiver may be associated with the sensor 76 to send information regarding the sensed physical parameter to the extracorporeal wireless remote control. The wireless remote control may have a signal transmitter or transceiver and the in-body control unit 56 may have a signal receiver or transceiver. Alternatively, the wireless remote controller may have a signal receiver or transceiver and the internal control unit 56 may have a signal transmitter or transceiver. The transceivers, transmitters and receivers described above can be used to send information or data related to the expansion device 10y from inside to outside the patient's body.

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

When the motor/pump unit 44 and the battery 70 for powering the motor/pump unit 44 are implanted, the battery 70 may include a transceiver for sending information regarding the status of the battery 70. More precisely, when charging the battery or accumulator with energy, feedback information relating to the charging process is sent and the energy supply is modified accordingly.

FIG. 90 illustrates an alternative embodiment in which the expansion device 10y is adjusted from outside the patient's body. The bariatric treatment system 28 has an expansion device 10y connected to a battery 70 via a subcutaneous switch 80. Therefore, the adjustment of the expansion device 10y is performed non-invasively by manually pressing the subcutaneous switch, which switches the operation of the expansion device 10y on and off. It is understood that the illustrated embodiments are simplified and that additional components such as an internal control unit or any other part disclosed herein may be added to this obesity treatment system. I want to.

FIG. 91 illustrates an alternative embodiment in which the bariatric treatment system 28 has an expansion device 10y fluidly connected to a hydraulic fluid reservoir 52. The non-invasive adjustment is performed by manually pressing the hydraulic reservoir connected to the expansion device 10y.

Another embodiment of a system according to the present invention provides feedback information regarding at least one functional parameter of the dilation device or system or a physical parameter of the patient, thereby optimizing the operation of the device to optimize the operation of the patient's body. It has a feedback device that sends information from inside to outside.

One suitable functional parameter of the device corresponds to the transfer of energy to charge the internal energy source.

In FIG. 92, one configuration is schematically shown for delivering the correct amount of energy to the bariatric treatment system 28 implanted in a patient whose skin 36 is shown in vertical lines. The expansion device 10y is connected to an implanted energy conversion device 30 which is also located inside the patient and is preferably located just below the patient's skin 36. Generally speaking, the implanted energy conversion device 30 may be placed in the abdomen, thorax, muscle fascia (eg, in the abdominal wall), subcutaneously, or any other suitable location. The implanted energy conversion device 30 is wireless energy transmitted from an extracorporeal energy source 34a provided within an extracorporeal energy transmission device 34 located outside the patient's skin 36 proximate to the implanted energy conversion device 30. Adapted to receive E.

As is well known in the art, wireless energy E is generally associated with a primary coil located within the extracorporeal energy source 34a and an adjacent secondary coil located within the implanted energy conversion device 30. Can be delivered using any suitable transdermal energy transfer (TET) device, such as a device including When a current is supplied through the primary coil, energy in the form of a voltage is induced in the secondary coil, which energy is stored, for example, by an energy storage device, such as a battery or a capacitor, or an accumulator, after storing the incoming energy. It can be used to activate an expansion device. However, the invention is not generally limited to any particular energy transfer technology, TET device or energy storage device, and any type of wireless energy may be used.

The amount of energy received by the device inside the body can be compared to the amount of energy used in the device. It should be understood that the term "used in the device" also includes the energy stored by the device. The amount of energy transferred may be adjusted by the extracorporeal control unit 34b, which controls the extracorporeal energy source 34a based on a predetermined energy balance, as described above. To deliver the correct amount of energy, the energy balance and the amount of energy required is determined by the internal control unit 56 connected to the expansion device 10y. Therefore, the internal control unit 56 measures the amount of energy needed to properly operate the expansion device 10y, such as by measuring appropriate properties of the expansion device 10y, which is not shown, but which is obtained by a suitable sensor or the like. It may be configured to receive various measurements obtained by indicating in some manner. Further, the current condition of the patient may also be sensed by a suitable measuring device or sensor to provide parameters indicative of the patient's condition. Therefore, these characteristics and/or parameters are related to the current state of the expansion device 10y, such as power consumption, mode of operation and temperature, as well as the state of the patient as indicated by, for example, temperature, blood pressure, heartbeat and respiration. You can

Further, an energy storage device or accumulator 58 may optionally be connected to the implanted energy conversion device 30 to store the received energy for later use by the expansion device 10y. Alternatively or additionally, the characteristics of this cumulator, which also indicate the amount of energy required, may be measured. The accumulator may be replaced by a battery and the characteristic being measured may be related to the current state of the battery such as voltage, temperature and the like. In order to provide sufficient voltage and current to the expansion device 10y, as well as to prevent excessive heating, the battery provides a reasonable amount of energy from the implanted energy conversion device 30, not too little or too much. It should be clearly understood that by receiving it must be optimally charged. The accumulator may be a capacitor with corresponding characteristics.

For example, the characteristics of the battery may be periodically measured to determine the current state of the battery, which may be stored in a suitable storage means within the internal control unit 56 as information regarding the state. Thus, as new measurements are obtained, the stored information about battery status may be updated accordingly. In this way, the state of the battery can be "calibrated" by delivering the right amount of energy, thereby maintaining the battery in optimal condition.

Therefore, the internal control unit 56 determines the energy distribution based on the measurements taken by the sensors or measuring devices mentioned above of the expansion device 10y or the patient or the energy storage device if used or any combination thereof. It is adapted to determine the balance and/or the amount of energy currently required (energy per unit time or energy stored). The intracorporeal control unit 56 is further connected to an intracorporeal signal transmitter 82 configured to transmit a control signal indicative of the determined required amount of energy to an extracorporeal signal receiver 34c connected to the extracorporeal control unit 34b. To be done. In this case, the amount of energy transmitted from the external energy source 34a can be adjusted in response to the received control signal.

Alternatively, the sensor readings may be transmitted directly to the extracorporeal control unit 34b, where the energy balance and/or the amount of energy currently required may be determined by the extracorporeal control unit 34b, thus The functions of the internal control unit 56 described above are incorporated in the external control unit 34b. In this case, the internal control unit 56 may be omitted, and the sensor measurements are fed directly to the internal signal transmitter 82, which transmits these measurements to the external signal receiver 34c and the external control unit 34b. Send to. Thereafter, based on these sensor measurements, the energy balance and the amount of energy currently needed can be determined by the extracorporeal control unit 34b.

Therefore, this solution employs feeding back information indicating the required energy, which is more efficient than the conventional solution. This is because the energy that is compared to the energy received is based on, for example, the amount of energy, the energy difference, or the energy rate received that is compared to the energy rate used by the expansion device. This is because it is based on the actual amount used. The expansion device may use the received energy, either for consumption or for storage in an energy storage device or the like. Therefore, the parameters discussed above are used as a tool to determine the actual energy balance when they are relevant and required. However, these parameters may also be required by nature, especially for any action taken internally to activate the expansion device.

The internal signal transmitter 82 and the external signal receiver 34c may be implemented as separate units using appropriate signal transmission means such as radio wave, IR (infrared) or ultrasonic signals. Alternatively, the intracorporeal signal transmitter 82 and the extracorporeal signal receiver 34c may be integrated into the implanted energy conversion device 30 and extracorporeal energy source 34a, respectively, using essentially the same transmission techniques. Thus, control signals can be sent in the opposite direction when transmitting energy. The control signal may be modulated in frequency, phase or amplitude.

In summary, the energy supply arrangement shown in FIG. 28 basically operates in the following manner. First, the energy balance is determined by the internal control unit 56. A control signal indicating the amount of energy required is further generated by the internal control unit 56, and the control signal is transmitted from the internal signal transmitter 82 to the external signal receiver 34c. Alternatively, the energy balance may be determined by the extracorporeal control unit 34b, instead of relying on the instrument described above. Here, the control signal may carry measurement results from various sensors. The amount of energy emitted from the extracorporeal energy source 34a may then be controlled by the extracorporeal control unit 34b based on the determined energy balance, eg, in response to the received control signal. This process may be repeated intermittently at specific intervals while continuing to transfer energy, or it may be performed to some extent in transferring energy.

The amount of energy transferred can generally be adjusted by adjusting various transfer parameters of the extracorporeal energy source 34a, such as voltage, current, amplitude, wave frequency, and pulse characteristics.

Thus, a method of controlling the transmission of wireless energy delivered to an electrically actuated expansion device implanted in a patient is provided. The wireless energy E is located inside the patient, transmitted from an extracorporeal energy source located outside the patient, and connected to an expansion device to directly or indirectly supply the received energy to the expansion device. Received by the internal energy receiver. The energy balance is determined between the energy received by the internal energy receiver and the energy used in the expansion device. The transmission of wireless energy E from the extracorporeal energy source is then controlled based on the determined energy balance.

Also provided is a system for controlling the transmission of wireless energy delivered to an electrically actuated expansion device implanted in a patient. The system is adapted to transmit wireless energy E from an extracorporeal energy source located outside the patient, which wireless energy E supplies the received energy directly or indirectly to the expansion device. Received by an implanted energy conversion device located inside the patient, which is connected to the expansion device. The system further determines an energy balance between the energy received by the implanted energy conversion device and the energy used by the expansion device, and wireless energy from the extracorporeal energy source is based on the determined energy balance. It is adapted to control the transmission of energy E.

The functional parameters of the device correspond to the transfer of energy to charge the internal energy source.

In yet an alternative embodiment, the extracorporeal energy source is controlled from outside the patient's body to release electromagnetic wireless energy, and the released electromagnetic wireless energy is used to activate the expansion device. ..

In another embodiment, the extracorporeal energy source is controlled from outside the patient's body to release non-magnetic wireless energy, and the released non-magnetic wireless energy is used to activate the expansion device. It

Those skilled in the art will appreciate that the various embodiments described above according to FIGS. 17-29 can be combined in many different ways. For example, the electrical switch 38 operated by polarization energy may be incorporated into any of the embodiments of FIGS. 11, 18-24 and the hydraulic valve shift device 54 may be incorporated into the embodiment of FIG. , The gear box 74 may be incorporated into the embodiment of FIG. It should be noted that a switch simply means any electronic circuit or electronic device.

We have described wireless transmission of energy to actuate an expansion device to enable non-invasive manipulation. It should be appreciated that the expansion device may also be actuated by wire bound energy. One such example is shown in FIG. 93, where an extracorporeal switch 84 is provided between the extracorporeal energy source 34a and an operating device such as an electric motor that regulates the expansion device 10y by power lines 86 and 88. Are interconnected by. The extracorporeal control unit 34b controls the activation of the extracorporeal switch so that the expansion device 10y is activated properly.

(Hydraulic or pneumatic power supply)
94-97 show in more detail block diagrams of four different modes of hydraulic or pneumatic powering of a device for treating obesity according to the present invention.

FIG. 94 shows an apparatus for treating obesity as described above with reference to any of FIGS. The apparatus includes an expansion device 10y and further includes a separate conditioned reservoir 16, a one-way pump 44, and a reciprocal valve 54.

FIG. 95 shows expansion device 10y and fluid reservoir 16. Adjustment of the dilation device can be done without any valve by moving the wall of the regulating reservoir or by changing the size of the regulating reservoir in any other way, and moving the wall of the reservoir. Can always move the fluid freely.

FIG. 96 shows device 10y, two-way pump 44 and conditioned reservoir 16.

FIG. 97 shows a block diagram of a reburst servo system in which a first closed system controls a second closed system. The servo system has a conditioning reservoir 16 and a servo reservoir 90. The servo reservoir 90 mechanically controls the expansion device 10y via a mechanical interconnect 94, the expansion device having an expandable/contractible cavity. The cavity may be expanded or contracted, preferably by supplying hydraulic fluid from a large adjustable reservoir 92 fluidly connected to the expansion device 10y. Alternatively, the cavity contains a compressible gas, which may be compressed or expanded under the control of servo reservoir 90.

The servo reservoir 90 may be part of the expansion device itself.

In one embodiment, the conditioned reservoir is placed subcutaneously under the patient's skin 36 and is manipulated by pushing its outer surface with a finger. This obesity treatment system is shown in Figures 98a-c. In FIG. 98a, the flexible adjustment reservoir 16 under the skin is shown connected by a conduit 18 to a raised servo reservoir 90. The bellows type servo reservoir 90 is included in the flexible expansion device 10y. In the situation shown in FIG. 98 a, the servo reservoir 90 contains a minimum amount of fluid, with most of the fluid found in the conditioned reservoir 16. Since the servo reservoir 90 and the expansion device 10y are mechanically interconnected, the outer shape of the expansion device 10y is in a contracted state. That is, the expansion device 10y occupies a volume less than the maximum volume. This maximum volume is indicated by the dotted line in this figure.

FIG. 98b shows a user, such as a patient, having a device implanted therein, depressing the conditioned reservoir 16, thereby pumping the fluid contained therein through the conduit 18. And is encased in the servo reservoir 90, which causes the servo reservoir 90 to expand longitudinally due to its bellows shape. This expansion then causes the expansion device 10y to expand and occupy the maximum volume, thereby expanding the stomach wall (not shown) with which the expansion device 10y is in contact.

The adjusting device 16 preferably comprises means for maintaining its shape after compression. Thus, by this means, which is shown schematically as 16a in the figure, the expansion device 10y maintains the expanded position even when the user releases the adjustment reservoir. In this way, the regulatory reservoir essentially acts as an on/off switch for the bariatric treatment system.

An alternative embodiment of hydraulic or pneumatic operation will now be described with reference to Figures 99 and 100a-c. The block diagram shown in FIG. 99 includes a first closed system that controls a second closed system. This first system has a conditioning reservoir 16 and a servo reservoir 90. The servo reservoir 90 mechanically controls a large adjustable reservoir 92 via a mechanical interconnect 94. The expansion device 10y having an inflatable/deflateable cavity is then supplied with hydraulic fluid from a large adjustable reservoir 92 fluidly connected to the expansion device 10y, thereby allowing the large adjustable reservoir 92 to Controlled.

An example of this embodiment will now be described with reference to Figures 100a-c. As in the previous embodiment, the conditioned reservoir is placed subcutaneously under the patient's skin and manipulated by pushing its outer surface with a finger. The conditioning reservoir 16 is fluidly connected by a conduit 18 to a bellows type servo reservoir 90. In the first closed system 16, 18, 90 shown in FIG. 34 a, the servo reservoir 90 contains a minimal amount of fluid and most of the fluid is found in the conditioning reservoir 16.

Servo reservoir 90 is mechanically connected to a larger adjustable reservoir 92, which again has a bellows shape but a larger diameter than servo reservoir 90 in this embodiment. The large adjustable reservoir 92 is fluidly connected to the expansion device 10y. This is because the user pushes the adjustment reservoir 16 to displace the fluid from the adjustment reservoir 16 to the servo reservoir 90, which causes the servo reservoir 90 to expand, thereby expanding a large amount of fluid from the large adjustable reservoir 92. This means that the device 10y is displaced. That is, in this reburst servo, the adjustment reservoir having a small volume is squeezed with a strong force, thereby moving a larger total area with a weak force per unit area.

Similar to the previous embodiment described above with reference to Figures 98a-c, the conditioning reservoir 16 preferably comprises means for maintaining its post-compression shape. Thus, by this means, which is shown schematically as 16a in the figure, the expansion device 10y remains in the unfolded position when the user releases the adjustment reservoir. In this way, the regulatory reservoir essentially acts as an on/off switch for the bariatric treatment system.
(Surgical treatment method for patients suffering from reflux and obesity) METHOD

A method for surgically treating an obese patient who also suffers from reflux comprises the steps of incising an opening in the patient's abdominal wall, incising an area around the stomach, and providing a device for treating a portion of the patient's stomach wall. And sewing the stomach wall.

The device for treating obesity and reflux preferably comprises the steps of inserting a needle or tubular device into the abdomen of the patient's body, and filling the patient's abdomen with gas to expand the patient's abdominal cavity. Or using a tubular instrument, placing at least two laparoscopic trocars in the patient's body, inserting a camera into the patient's abdomen through one laparoscopic trocar, and said at least two abdominal cavity Inserting at least one dissecting instrument through one of the spectroscopic trocars to dissect the intended placement area of the patient, and placing the device for treating obesity connected to the stomach wall. It is placed in the patient by a laparoscopic laparotomy approach.

The method may further include the step of expanding at least a portion of the stomach wall and adjusting at least one expansion device post-operatively to adjust the expansion device from outside the patient's body to affect the patient's appetite. ..

(Apparatus)
Next, with reference to FIGS. 101a to 101i, an intraluminal method for invading the expansion device 10 to the outside of the stomach wall 12 will be described. First, as seen in FIG. 101a, the instrument 600, which is preferably a gastroscopy instrument, is inserted into the patient's mouth. The device has injection devices 601, 602 for injecting either a fluid or a device into the stomach of a patient. The instrument 600 further comprises a control unit 606 adapted to control the operation of the instrument. To this end, the control unit 606 has one or more steering devices in the form of two joysticks 603 and two control buttons 604 in the illustrated embodiment. To display the image provided by the optical device for looking inside the stomach, such as a camera (not shown) positioned at the outer end of the elongated member 607, as seen in FIGS. 101e-i. In addition, a display 605 is provided. This camera, which may have electrical wires for connection extending along the elongated member, is assisted by a light source (not shown) located distally on the elongated member to illuminate the interior of the stomach. Can be done. The optical device may further include an optical fiber disposed along the elongate member and extending out of the patient's body for external viewing of the interior of the stomach.

The device is further inserted into the esophagus and into the patient's stomach, as seen in Figure 101b. The device 600 creates a hole 12by in the wall of the stomach 12y. For this purpose, the instrument comprises one or more cutters 615 at the distal end. Of course, these cutters may be variously designed, such as a toothed drum cutter that rotates around the central axis of the tubular instrument.

After the hole is made in the stomach wall, the distal end of the device 600 is inserted through the hole 12by to reach the outside of the stomach wall 12ay. This is shown in FIG. 101c, which is a side view of stomach 12y and FIG. 101d, which is a cross-sectional view of the stomach of FIG. 101c taken along line Vd-Vd.

Device 600 is adapted to create a "cavity" or "bag" outside the stomach around hole 12by in stomach wall 12y. Next, the equipment and method for making this bag will be described.

101e-i show a gastroscopy or laparoscopy instrument for invading the dilation device 10 into the gastric wall 12 of a patient by making a bag of material of the gastric wall 12 for placement of the dilation device 10. There is. The instrument, generally indicated at 600, has an elongate member 607 including a proximal portion and a distal portion, the elongate member 607 having a diameter that is less than the diameter of the patient's esophagus and is flexible. The flexible elongate member 607 can be introduced so that its distal end is first passed through the patient's throat and into the esophagus and further into the stomach 12 to reach the stomach wall 12a.

A gastric penetrating device or cutter 615 for penetrating the stomach wall 12a is provided at the distal end of the elongated member 607 to create a hole in the stomach wall 12a and allow the elongated member 607 to be introduced therethrough. The gastric penetrating device 615 may be adapted to operate to be retracted after the gastric basal wall 12a has been pierced so as not to further damage tissue within the body. The instrument further comprises a special retention device 609 provided on the elongate member 607 proximal of the penetrating device 615.

The elongate member further comprises an inflatable member 611 adapted to be expanded after the elongate member has penetrated the stomach wall 12a, thereby providing a cavity or bag adapted to hold the volume filling device 610. Assist in making. The inflatable member 611 may comprise an inflatable circular balloon provided around the distal end portion of the flexible elongate member 607.

The method steps in the invagination of the volume filling device will now be described in detail. After the device 600 is inserted into the stomach 12, a gastric penetrating device 615 is placed therein to contact the gastric wall 12 as seen in FIG. 101e. The gastric penetrating device or cutter 615 is then extruded to create the hole 12b in the stomach wall, after which at least the inflatable member 611 is extruded through the hole 12b in the stomach wall. In this step, the special holding device 609 is pushed out into the holding state, where it presents an essentially circular abutment surface against the stomach wall 12 as seen in Fig. 101f. It extends radially to form. In this way, insertion of gastric penetrating device 615 and inflatable member 611 through hole 12 in the stomach wall is limited to the position shown in FIG. 101f.

The expandable member 611 is then expanded. In this case, the inflatable member comprises a balloon or the like into which air or another fluid is infused.

The portion of the elongate member 607, including the inflatable member 611, is then retracted proximally as shown by the arrow in FIG. 101g, whereby the stomach wall 612 is basket-shaped or cup-shaped created by the special retention device 609. Is pulled into the structure.

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 has a suture or stapling end 613 adapted to close a cavity or bag with a stomach-gastric suture or staple 14.

In the next step shown in FIG. 101h, the inflatable expansion device 10 is placed in the cup-shaped structure in a collapsed state. The expansion device 10 is then expanded to the expanded or expanded state seen in FIG. 101i. This expansion of expansion device 10 may be accomplished by injecting a fluid or gel into the deflated expansion device. This may be achieved by injecting a curable material, which forms a solid device 10. Thus, the dilation device 10 shown in FIGS. 101h and 101i is simply a balloon-like device that is later filled with a fluid or gel, or alternatively, simply injected into the cup-like structure formed by the stomach wall 12. Indicates any of the materials that are used.

The fluid used to fill the expansion device 10 may be any suitable fluid suitable for filling the expansion device 10, such as saline. In another embodiment, where the fluid is a fluid adapted to be transformed into a solid phase, the fluid may be liquid polyurethane.

The fluid is isotonic to minimize or prevent leakage altogether. That is, the fluid has the same osmolarity as human body fluids. Another approach to prevent diffusion is to provide fluids containing macromolecules such as iodine molecules.

The stomach-gastric-suture or staple 14 is preferably adapted to contact the gastric wall 12 to promote in-growth of body tissue and long-term fixation of the position of an expansion device attached to the gastric wall. It comprises a fixed part forming a structure such as a net-like structure.

Thereby, the inflatable expansion device 10 is invaded into the portion of the patient's stomach wall outside the stomach wall 12 in its expanded or expanded state.

In one or more of the steps described above, the stomach may be inflated with gas, preferably using a gastroscopy instrument.

The expansion device 10 described above with reference to Figures 101a-i has been described as an inflatable expansion device. It is to be understood that the expansion device may be a resilient expansion device that has elasticity such that it can be compressed for insertion into a gastroscopy instrument and expanded into an expanded state after being removed from the instrument. ..

In one embodiment, the expansion device 10 includes an inflatable expansion device 10 that can be expanded to an expanded state. In this case, the inflatable device 10 comprises an inlet port 18b for fluid and is adapted to be connected to a gastroscopy instrument. This embodiment will now be described in detail with reference to Figures 102a-102d.

The inflatable expansion device in its unexpanded state is shown in Figure 102a. This inflatable expansion device is essentially a deflated balloon-like expansion device 10 having an inlet port 18b. In this state, the inflatable device 10 has a diameter of up to a few millimeters, and thus may be used with a tubular gastroscopy instrument 600 or with a laparoscopic laparotomy procedure using the tubular instrument 600 shown in FIG. 102b. It can be inserted into the stomach through the patient's esophagus via a laparoscopic trocar by means of an (abdominal laparascopic method). The device has an outer sleeve 600a and an inner sleeve 600b that can be displaced longitudinally with respect to the outer sleeve. The inner sleeve comprises a cutter in the form of a cutting edge 615 at the distal end. This cutting edge, as explained in detail later,
It can be used to make a hole in the stomach wall.

When the device reaches the stomach wall from inside or outside the stomach wall, the inner sleeve is advanced forward from a position in the outer sleeve to contact stomach wall 12a, as seen in Figure 102c. The inner sleeve cutting edge 615 then cuts a hole in the stomach wall whereby the volume filling device 10 is then inserted therethrough as seen in FIG. 102d. A piston 602 may be provided on the device to push the expansion device through the hole. Accordingly, the instrument further comprises a piston 602 adapted to push the deflated expansion device 10 from a position within the inner sleeve shown in FIG. 102b to a position outside the inner sleeve shown in FIG. 102d.

Another protective sleeve (not shown) may be provided around the expansion device to protect the deflated expansion device 10 from the inner sleeve cutting edge 615.

102a-j show an instrument used in the procedure of engaging the dilation device 10 with the stomach wall 12 of a patient. The instrument is adapted to be inserted through a narrow tubular shaped object, such as a gastroscope used in intraluminal procedures, or a laparoscopic trocar used in laparoscopy procedures. The device has an elongated member 650 adapted to be flexible by a structure having a plurality of ring-shaped members, the elongated member 650 being made of a flexible or adjustable material. It may be envisioned that it is adapted to be flexible as well. The elongate member 650 is inserted into the body and positioned from outside or inside the stomach wall 12 of the patient, near the stomach wall 12 of the patient. The elongate member 650 has a special retention device 651 adapted to retain the stomach by a mechanical gripping member or by vacuum. The special retention device 651 allows the special retention device 651 to move relative to the elongate member 650 such that a portion of the retention device 651 having a mechanical gripping member or vacuum element is placed on the patient's stomach wall 12. It has a first joint 652 and a second joint 653 for being placed in contact. FIG. 102b shows a special retaining device 651 placed in contact with the stomach wall 12 of a human patient, after which the special retaining member 651 is connected to the stomach wall 12 to retain it. FIG. 102c shows the instrument as the step of advancing the pushing rod 654 out of the elongated member 650 is performed. The pushing rod 654 pushes against the stomach wall 12 to create a cavity or bag of the stomach wall 12. 102d shows the instrument rotated 90° relative to FIGS. 102a-c. This figure is operatively attached to two sides of elongate member 650 and is in contact with stomach wall 12 while retaining stomach wall 12 when pushing rod 654 is pushed to create a cavity or bag. The holding members 651a and 651b are shown. When the pushing rod 654 pushes the stomach wall 12 to the desired position, the special retention device 651a,b moves towards the pushing rod 654, thereby closing the cavity or bag.

The cavity or bag needs to be sealed after formation. FIG. 103f shows the suturing or stapling device 655 advanced from the elongate member 650. The suturing or stapling device 655 is positioned to contact the stomach wall and then initiates suturing or stapling the stomach wall 12 to form a gastric-gastric suture or staple 14 seal. As shown in FIGS. 103g and 103h, the device is moved along the stomach wall 12 of the patient, thereby using the device to form and seal a cavity or bag. Once the desired size cavity or bag is formed and sealed, the insertion member 656 is advanced from the elongate member 650. The insert member 656 is adapted to insert the inflatable expansion device 10 described herein above. After the insertion member 656 is positioned in the cavity or bag, the expansion device 10 is activated by a pressurized fluid or gas or by a mechanical advancement member for pushing the expandable expansion device 10 into the cavity or bag. It is inserted through the insert member 656 into the cavity or bag. The insert then inflates the inflatable expansion device with a fluid or gas and uses a gastro-gastric suture or staple 14 to seal the last section of the bag. Although the described embodiments describe the insertion process of an inflatable expansion device, it can be envisioned as well that expansion device 10 is made expandable by being made of an elastic material.

104a-f show an instrument used in the procedure of engaging the expansion device 10 with the stomach wall 12 of a patient. The instrument is adapted to be inserted through a narrow tubular shaped object, such as a gastroscope used in intraluminal procedures, or a laparoscopic trocar used in laparoscopy procedures. The device has an elongated member 660 adapted to be flexible by a structure having a plurality of ring-shaped members, the elongated member 660 being made of a flexible or adjustable material. It may be envisioned that it is adapted to be flexible as well. The elongate member 660 is inserted into the body and is positioned proximate to the patient's stomach wall 12 from outside or from the patient's stomach wall 12. The elongate member 660 has a plurality of special retention devices 661 adapted to retain the stomach by mechanical gripping members or by vacuum. The particular retention device 661 is locked in position along the elongated member 660 by the locking ring 662. The special retention device is made of a flexible material and is pre-bent so that it expands into a funnel-shaped device when the locking ring 662 is removed. A special holding device in a funnel-shaped inflated state is shown in Figure 104b. FIG. 104b further shows that the special retention device 661 is positioned in contact with the stomach wall 12 of a human patient, after which the special retention member 661 is connected to the stomach wall 12 to retain the stomach wall 12. To be done. FIG. 104c shows the instrument as the step of advancing the pushing rod 664 out of the elongated member 660 is performed. The pushing rod 664 pushes against the stomach wall 12 to create a cavity or bag of the stomach wall 12. When the pushing rod 664 pushes the stomach wall 12 to the desired position, the special retention device 661 moves towards the pushing rod 664, thereby closing the cavity or bag.

The cavity or bag needs to be sealed after formation. FIG. 104d shows the suturing or stapling device 665 advanced from the elongated member 660. The suturing or stapling device 665 is positioned to contact the gastric wall 12 and then initiates suturing or stapling the gastric wall 12 to form a gastric-gastric suture or staple 14 seal. The insertion member 666 is then advanced from the elongated member 660 and the special retention device 661 is retracted. The insert member 666 is adapted to insert the inflatable expansion device 10 described herein above. After the insertion member 666 is positioned in the cavity or bag, the expansion device 10 is moved by pressurized fluid or air or by a mechanical advancement member for pushing the expandable expansion device 10 into the cavity or bag. It is inserted through the insert member 666 into the cavity or bag. The insert member 666 then inflates the inflatable expansion device with the fluid or gas and uses the gastro-gastric suture or staple 14 to seal the last section of the bag. Although the described embodiments describe the insertion process of the inflatable expansion device 10, it can likewise be envisaged that the expansion device 10 will be inflatable by being made of an elastic material. FIG. 40f shows the expansion device 10 invaginated in the gastric wall 12 within a cavity or bag sealed by a gastro-gastric suture or staple 14.

FIG. 105a illustrates an instrument used in a method of engaging an expansion device with gastric wall 12 according to any of the embodiments herein. The device has an elongated member 670 adapted to be flexible by a structure having a plurality of ring-shaped members, the elongated member 670 being made of a flexible or adjustable material. It may be envisioned that it is adapted to be flexible as well. The elongate member 670 is inserted into the body and positioned from the inside of the patient's stomach wall 12 near the patient's stomach wall 12. The gastric penetrating member 672 is retractably secured to a protective sleeve 673 adapted to protect human tissue from the sharp penetrating member 672 or cutter 672 after the incision process has been performed, and the distal portion of the elongated member 670 is retracted. It is placed at the end.

Figure 105b shows the device including the elongate member 670 after the dissection process has been performed and the gastric penetrating member or cutter 672 has been retracted into the protective sleeve 673. A guide wire 671 is pushed through the elongate member 670 and through a hole made in the stomach wall 12 and out through the abdomen and placed inside the patient's skin, where the patient's skin is guided. Is pierced externally to allow it to exit the abdomen. A guide wire 671 can then be used from the inside of the stomach to guide the conduit 18 or lead attached to the expansion device 10 placed in the stomach. Expansion device 10 with conduit 18 or electrical leads is expansion device 10 according to any embodiment herein. Guiding the conduit 18 or electrical leads allows the conduit 18 or electrical leads to be attached from outside the abdomen to the control unit 42 that is placed subcutaneously on the patient.

FIG. 106 shows a flowchart illustrating the steps required in an intraluminal procedure for inserting a device for expanding a portion of the stomach wall, which involves inserting the device into the patient's esophagus 203 (step 1a). ), using an instrument, to insert the device through the esophagus 203 into the patient's stomach (step 2a), placing the device 10 in contact with the stomach wall 12 (step 3a), and placing the device on the stomach wall 12. Securing the device to the stomach wall 12 to allow the portion to be unrolled. The described method can further include the step of non-invasively adjusting the device after placement of the apparatus is complete.

FIG. 107 shows a flow chart illustrating the steps required in an laparotomy procedure for inserting a device for expanding a portion of the stomach wall, which procedure comprises incising a hole in the patient's abdominal wall (step 1b). ), incising a region around the stomach (step 2b), placing the device in contact with the stomach (step 3b), and allowing the device to expand a portion of the stomach wall Fixing the device to the stomach wall directly or indirectly via the invagination of the stomach wall (step 4b). The method described may further include the steps of using sutures or staples 14 to close the hole in the abdomen and non-invasively adjusting the device after placement of the device is complete.

FIG. 108 shows an embodiment of the device according to the invention. FIG. 108 shows a segment of a movement restriction device being assembled prior to implantation in a patient in need of treatment for reflux disease. A segment of the movement restriction device includes a core portion 560 and four outer portions 561a-561d. The generally cylindrical core portion is provided with an upper portion 560′ and is further provided with four slits 562a-562d that are symmetrically distributed and extend along the outer surface around the core portion. The outer portions 561a-561s are generally shown as portions of a sphere having an inner surface and an outer surface, each portion provided with a protruding flange 563a-563d extending along the inner surface. In the illustrated embodiment, the flanges 563a-563d are adapted to the slits 562a-562d, but may be configured to form a clearance fit between the flanges and the slits, whereby the movement restriction device to be assembled is It will be firmly assembled at the implantation target position above the cardia. If the movement restriction device is accidentally displaced from this position into the gastric cavity, the clearance fit configuration allows the segment to be disassembled more quickly. The core portion extends through a first channel 565 in the core portion and further through a corresponding channel 565a between two adjacent orifices at a protrusion 563a in the first outer portion 561a. It is connected to the wire 564. When the guide wire 564 is actuated by being displaced away from the upper surface 560' of the core portion, the first outer portion 561a is displaced toward the core portion and the flange 563a abuts the slit 562a. , The first outer portion is assembled to the core portion 560. As illustrated in FIG. 109, this action is then followed by a second outer portion by a guide wire 564 connected through the second channel 566 to a corresponding channel in the flange 563b of the second outer portion 561b. But it is repeated. FIG. 110 illustrates this action, again for assembling the third outer portion 561c, and the third channel 567, for connecting the guide wire 564 to the flange 563c. FIG. 111 shows the final fourth outer portion 561d assembled via flange 563d and channel 568. FIG. 112 shows the final assembled movement restriction device. FIG. 113a shows a more detailed view of the core portion illustrating the system of channels for the guide wire. 113b to 113d are cross-sectional views of planes I-I, II-II, III-III and IV-IV at respective heights of each of the four channels.

The guide wire is made of a biodegradable material that degrades so that the segments can be easily disassembled when the movement restriction device is accidentally displaced from its implantation position. The segments shown are made from a solid biocompatible material, each sized and shaped so that they can easily pass through the gastrointestinal system when the movement restriction device is degraded. When implanting a movement restriction device assembled in this way, any of the methods described above are suitable.

FIG. 114 illustrates one embodiment of the movement restriction device being assembled. The outer shapes of the core portion and the segments are the same as those shown in FIG. 108, but the flanges of the segments 563a-d have recesses 563'a that fit into the protrusions 562'a-d of the slits 562a-d of the core portion. ~d are provided and the assembled movement restriction device will be locked in two different planes. In this embodiment, these planes are arranged vertically. 115 shows another embodiment of the movement restriction device according to FIG. 114, without any guide wire and with no features for the guide wire in the segment. In this embodiment, the element for locking the conforming element needs to be adapted to assist in disassembling when the displacement limiting device is accidentally displaced from the implantation position.

It is apparent from the overall description and the appended claims that many other ways of designing a movement restriction device are possible without departing from this concept.

It should be noted that all embodiments, or the features of one embodiment, as well as any method or step of one method, may be combined in any way, unless the combination is clearly inconsistent. .. It should be noted that the entire description is considered as describing both the apparatus or device adapted to implement a method and the method itself.

While particular embodiments of the present invention have been shown and described herein, many other alternatives are envisioned and many additional advantages, modifications and changes are within the spirit and scope of the invention. It should be understood that one of ordinary skill in the art would readily come up with no deviations. Accordingly, the invention in its broader aspects is not limited to the specific details, representative devices, and illustrated examples shown and described herein. Therefore, various modifications may be made without departing from the spirit and scope of the general inventive concept as defined by the appended claims and their equivalents. Therefore, it is to be understood that the appended claims cover all modifications and variations that come within the true spirit and scope of the invention. Many other embodiments can be envisioned without departing from the spirit and scope of the invention.

14 cardia; 14c cardia region; 22 sutures or staples 22;
310 migration restriction device; 310' proximal portion; 320' distal portion.

Claims (14)

An implantable medical device for treating reflux disease in a human patient, comprising:
The implantable medical device comprises a movement restriction device (10) having an outer layer comprising a biocompatible material,
The movement restriction device is adapted to be at least partially invaginated in the gastric fundus (16) of the patient,
As a result, the cardia notch of the patient's stomach is restricted from moving toward the patient's diaphragm, which causes the cardia (14) to slide through the patient's diaphragm, which is open into the patient's rib cage. Is prevented from
The implantable medical device comprises a retention device, the retention device being at least partially disposed inside an outer wall of the implantable medical device,
Implantable medical device. The implantable medical device of claim 1, wherein the retention device comprises at least one recess in a surface of the implantable medical device. The implantable medical device of claim 2, wherein the recess is a circular recess. The implantable medical device according to claim 2, wherein the recess is a raised ridge. The implantable medical device of claim 1, wherein the retention device comprises at least one hole in a surface of the implantable medical device. 6. The implantable medical device according to any one of claims 1-5, wherein the retaining device is adapted to be retained by a surgical instrument during implantation of the implantable medical device. 7. The implantable medical device of any of claims 1-6, wherein the implantable medical device is adapted to pass through a trocar. 8. The implantable medical device of any one of claims 1-7, wherein the implantable medical device is made of a homogeneous material. 8. The implantable medical device according to any one of claims 1-7, wherein the implantable medical device is filled with a fluid. 10. The implantable medical device according to claim 9, wherein the fluid is a gel. 11. The implantable medical device of any one of claims 1-10, further comprising a fixation device that indirectly or directly secures the movement restriction device to a patient's esophagus. The implantable medical device according to claim 11, wherein the second fixation device comprises at least one suture. 13. The implantable medical device of any of claims 1-12, wherein the movement restriction device comprises a core portion and at least one outer portion. 14. The implantable medical device according to claim 13, wherein the core portion comprises at least one hole.

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