System for treating gerd

Abstract

To provide a device for treating gastroesophageal reflux disease.SOLUTION: An implantable medical device for treating reflux disease in human patients has a movement limiting device (10) with an outer layer containing a biocompatible material. The movement limiting device is configured to be fully recessed into the wall of the patient's gastric fundus (16), and has a body (13) configured to rest against the wall of the gastric fundus (16) at a position between the patient's diaphragm and the wall of the gastric fundus (16), such that the patient's gastric fundoplication scar is restricted from moving toward the patient's diaphragm, thereby preventing the cardia (14) from sliding through the patient's diaphragm, which is open into the patient's intrathoracic; the movement limiting device has a non-penetrating hole located in the outer wall of the movement limiting device to hold the device by the surgical instrument while the device is implanted.SELECTED DRAWING: Figure 1A

Description

Technical Field

[0001] The present invention relates to an apparatus for treating gastroesophageal reflux disease (GERD). It relates to an apparatus for treating GERD, which includes a transplantable elongated movement restriction device having a proximal portion for maintaining the cardia in the correct position and a distal portion for stabilizing the proximal portion and additionally applicable to obesity treatment. This apparatus may further include a transplantable stimulation device adapted to engage the patient's cardiac sphincter and a control device for controlling the stimulation device to stimulate the cardiac sphincter. The present invention may further be combined with various techniques for treating obesity, specifically techniques for creating a feeling of fullness by expanding the stomach wall or filling the volume of the stomach.

[0002] The present invention relates to an anti-reflux disease treatment apparatus including a transplantable elongated movement restriction device having a proximal portion for maintaining the cardia in the correct position and a distal portion for stabilizing the proximal portion and additionally applicable to obesity treatment. This apparatus may further include a transplantable stimulation device adapted to engage the patient's cardiac sphincter and a control device for controlling the stimulation device to stimulate the cardiac sphincter. The present invention may further be combined with various techniques for treating obesity, specifically techniques for creating a feeling of fullness by expanding the stomach wall or filling the volume of the stomach. It relates to an anti-reflux disease treatment apparatus including a transplantable elongated movement restriction device having a proximal portion for maintaining the cardia in the correct position and a distal portion for stabilizing the proximal portion and additionally applicable to obesity treatment. This apparatus may further include a transplantable stimulation device adapted to engage the patient's cardiac sphincter and a control device for controlling the stimulation device to stimulate the cardiac sphincter. The present invention may further be combined with various techniques for treating obesity, specifically techniques for creating a feeling of fullness by expanding the stomach wall or filling the volume of the stomach. This apparatus may further include a transplantable stimulation device adapted to engage the patient's cardiac sphincter and a control device for controlling the stimulation device to stimulate the cardiac sphincter. The present invention may further be combined with various techniques for treating obesity, specifically techniques for creating a feeling of fullness by expanding the stomach wall or filling the volume of the stomach. This apparatus may further include a transplantable stimulation device adapted to engage the patient's cardiac sphincter and a control device for controlling the stimulation device to stimulate the cardiac sphincter. The present invention may further be combined with various techniques for treating obesity, specifically techniques for creating a feeling of fullness by expanding the stomach wall or filling the volume of the stomach. This apparatus may further include a transplantable stimulation device adapted to engage the patient's cardiac sphincter and a control device for controlling the stimulation device to stimulate the cardiac sphincter. The present invention may further be combined with various techniques for treating obesity, specifically techniques for creating a feeling of fullness by expanding the stomach wall or filling the volume of the stomach. This apparatus may further include a transplantable stimulation device adapted to engage the patient's cardiac sphincter and a control device for controlling the stimulation device to stimulate the cardiac sphincter. The present invention may further be combined with various techniques for treating obesity, specifically techniques for creating a feeling of fullness by expanding the stomach wall or filling the volume of the stomach. This apparatus may further include a transplantable stimulation device adapted to engage the patient's cardiac sphincter and a control device for controlling the stimulation device to stimulate the cardiac sphincter. The present invention may further be combined with various techniques for treating obesity, specifically techniques for creating a feeling of fullness by expanding the stomach wall or filling the volume of the stomach.

Background Art

[0003] Gastroesophageal reflux disease (GERD), also known as acid reflux disease, is a chronic condition that causes mucosal damage in the esophagus due to repeated acid reflux in the esophagus. This is generally caused by 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 the LES, reduced ability to eliminate gastric juice reflux from the esophagus, or esophageal hiatus hernia. This is generally caused by 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 the LES, reduced ability to eliminate gastric juice reflux from the esophagus, or esophageal hiatus hernia. This is generally caused by 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 the LES, reduced ability to eliminate gastric juice reflux from the esophagus, or esophageal hiatus hernia. This is generally caused by 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 the LES, reduced ability to eliminate gastric juice reflux from the esophagus, or esophageal hiatus hernia. This is generally caused by 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 the LES, reduced ability to eliminate gastric juice reflux from the esophagus, or esophageal hiatus hernia. This is generally caused by 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 the LES, reduced ability to eliminate gastric juice reflux from the esophagus, or esophageal hiatus hernia.

[0004] Gastroesophageal reflux disease can be treated by various different methods. Treatment methods include, but are not limited to, medical Both treatment and surgery are included. Standard where long-term use of drugs may be preferred The typical surgery is Nissen fundoplication, where the upper curve (base) of the stomach is wrapped around the LES to strengthen the sphincter and prevent acid reflux and possibly to repair a hiatal hernia. This procedure is often performed laparoscopically. Another surgery that has been used is the Anglechik prosthesis, where a device shaped like a horseshoe is placed around the esophagus above the gastroesophageal junction. The intended result is to prevent the gastroesophageal junction from slipping upward into the chest cavity. However, this device has many complications, including moving through and damaging the esophagus.

[0005]

[0006] Experience with the implantation of medical devices has shown that sutures between the implanted device and human tissue do not last long. When implanting a device for a long time, two things can be considered to keep the device in place. The first solution is to suture human tissue to human tissue to thereby hold the device in place. Another approach is to perform sutures to hold the device in place for a short time and grow human tissue into the device to hold the device in place over a long period.

[0007] A problem in preparing implantable devices related to the esophagus is that the outer surface of the esophagus is composed only of esophageal muscle tissue that is very easily damaged or penetrated. This is probably one of the reasons for many complications such as the movement of the device in the above-mentioned Anglechik prosthesis. ​​​​​​​​​​​​​​

[0008] On the other hand, the stomach has a serous membrane on its outside, which provides a stronger membrane for suturing. Therefore, suturing the device directly to the stomach wall avoids suturing the implanted device to the esophagus. This gives better results than using a conventional method.

[0009] There are currently treatments for GERD that are more effective than traditional treatments and do not cause serious complications. Long-term treatment is needed. Summary of the Invention [Problem to be solved by the invention]

[0010] The object of the present invention is to address some of the problems associated with the current surgical treatment of gastroesophageal reflux disease (GERD). Another object of the present invention is to overcome or at least reduce the symptoms of gastroesophageal reflux disease. These and other objects are set forth in the accompanying patent claims. This is achieved by the device described in the claims.

[0011] The object of the present invention is to provide a method for the treatment of obesity, which can be additionally provided with a reverse inflammatory agent having improved long-term properties. The present invention provides a device for treating vascular disease. [Means for solving the problem]

[0012] This and other objects are achieved by the device described in the appended claims. Generally, the present invention is adapted to be at least partially invaginated by a portion of the stomach wall of a patient. The present invention relates to a method for treating a human or mammalian subject, comprising: The present invention relates to an apparatus for treating reflux disease in a dairy patient. The device has a proximal portion and a distal portion and is adapted to interface with the patient's diaphragm and the wall of the fundus of the stomach when implanted in the patient. at a position between, the outer surface of its proximal portion is at least partially against the wall of the patient's gastric fundus and is adapted to rest in a state facing, as a result, when this movement restriction device is implanted in the patient, the cardiac incisure of the patient's stomach is restricted from moving towards the patient's diaphragm and thereby, the cardiac orifice is prevented from sliding through the patient's diaphragm that is open into the patient's thoracic cavity and the support pressure on the cardiac sphincter muscle exerted from the patient's abdomen is maintained. This device is also adapted to stabilize and hold the proximal portion by a distal portion that is adapted to substantially sink into the gastric wall in order to prevent the cardiac orifice from sliding through the patient's diaphragm that is open into the patient's thoracic cavity. The terms "proximal" and "distal" have their normal anatomical meanings. Thus, anatomically proximal means closer to the center of the body or at the beginning of a structure. In the present context proximal and distal refer to the portions of the movement restriction device at the implantation site. The length of the distal portion of the elongate movement restriction device that sinks in is long enough to stabilize the proximal portion of the elongate movement restriction device, thereby preventing the cardiac orifice from sliding through the patient's diaphragm that is open into the patient's thoracic cavity . The periphery of the distal portion of the elongate movement restriction device that sinks in is adapted to stabilize the proximal portion of the elongate movement restriction device , thereby preventing the cardiac orifice from sliding through the diaphragm that is open into the patient's thoracic cavity. The proximal portion of the movement restriction device has a size of at least 125 mm and a periphery of at least 15 mm. 3

[0013] Preferably, the device fixes the proximal portion of the movement restriction device to a position that restricts the movement of the gastric cardia incisure towards the patient's diaphragm and includes a transplantable first fixing device, and the outer surface of the movement restriction device substantially contacts the wall of the patient's gastric fundus. This first fixing device may include sutures or staples that integrally connect a plurality of portions of the gastric wall at the base that surround the proximal portion of the movement restriction device. That is, the movement restriction device is at least partially disposed within the recessed space. Therefore, by indirectly attaching the proximal portion of the transplantable movement restriction device in this manner, suturing between the movement restriction device and the tissue is no longer necessary, and the risk of complications is reduced. By maintaining the proximal portion of the movement restriction device in a fixed position in this manner, it has become an elastic suspension with improved long-term characteristics. The first fixing device such as sutures or staples integrally connects a plurality of portions of the gastric wall at the base to insert the proximal portion of the movement restriction device from either the inside or the outside of the patient's gastric wall. As an alternative, a structure that promotes tissue growth can be sutured to the gastric wall with a relatively large contact surface facing the stomach. Due to the relatively large surface of this structure such as a net, it is possible to allow human tissue to grow internally to hold the proximal portion of the movement restriction device in a fixed position over a long period of time. This structure that promotes tissue growth may have sutures or staples that attach a net-like structure to the gastric wall at the base. device and tissue is eliminated, and the risk of complications is reduced. By maintaining the proximal portion of the movement restriction device in a fixed position in this manner, it has become an elastic suspension with improved long-term characteristics. device and tissue is eliminated, and the risk of complications

[0014] The first fixing device such as sutures or staples inserts the proximal portion of the movement restriction device from either the inside or the outside of the patient's gastric wall by integrally connecting a plurality of portions of the gastric wall at the base. patient's gastric wall.

[0015] Alternatively, a structure that promotes tissue growth can be sutured to the gastric wall with a relatively large contact surface facing the stomach. Since the surface of this structure such as a net is relatively large, it is possible to allow human tissue to grow internally to hold the proximal portion of the movement restriction device in a fixed position over a long period of time. This structure that promotes tissue growth may have sutures or staples that attach a net-like structure to the gastric wall at the base.

[0016] ​​In addition to attaching the proximal portion of the movement restricting device to the gastric wall, a second fixation device may be employed. The second fixation device can be used to attach the proximal portion of the movement restricting device to the cardia. For example, the proximal portion of the movement restricting device can be attached to a position above the cardia, between the cardia and the diaphragmatic muscle, by being secondarily attached directly or indirectly through the gastric wall at the base. The second fixation device can approach the patient's His angle either indirectly or directly and fix the proximal portion of the movement restricting device to the wall of the patient's esophagus. The second fixation device preferably includes a plurality of sutures or staples that tie the wall at the base to the wall of the patient's esophagus to hold the movement restricting device in the above position.

[0017] The device may also include a third fixation device that indirectly or directly fixes the proximal portion of the movement restricting device to the patient's diaphragmatic muscle or another muscle tissue. The third fixation device preferably includes a plurality of sutures or staples that tie the wall at the base to the diaphragmatic muscle or another muscle tissue to hold the movement restricting device in the above position.

[0018] The proximal portion of the movement restricting device may be further adapted to be disposed either inside or outside the wall of the gastric base so as to be substantially or completely recessed by the wall of the patient's gastric base.

[0019] The proximal portion of the movement restricting device may be adapted to be disposed outside the patient's gastric wall such that the gastric lumen is substantially reduced by a volume that substantially exceeds the volume of the movement restricting device.

[0020] ​​​​​​​​​​​​At least a portion of the proximal portion of the movement restriction device may be made of a material that can be destroyed by gastric acid or not destroyed by gastric acid.

[0021] In one embodiment, the proximal portion of the movement restriction device is inflatable and adapted to be inflated with a gel or fluid. A fluid or gel containment member for containing the fluid for inflating the movement restriction device may be provided. For containing the fluid for inflating the movement restriction device. A fluid or gel containment member for containing the fluid for inflating the movement restriction device may be provided.

[0022] The proximal portion of the movement restriction device may comprise a homogeneous material and may be a solid body.

[0023] The proximal portion of the movement restriction device may include a surrounding wall that defines a chamber.

[0024] 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 high enough rigidity to maintain its shape without deforming even when subjected to the forces generated by the movement of the stomach. When the outer wall is rigid, the outer wall has a high enough rigidity to maintain its shape without deforming even when subjected to the forces generated by the movement of the stomach. 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 high enough rigidity to maintain its shape without deforming even when subjected to the forces generated by the movement of the stomach.

[0025] According to a preferred embodiment of the device, the proximal portion of the movement restriction device is adapted to be at least partially indented by the wall of the patient's gastric fundus and has a body adapted to have an outer surface containing a biocompatible material. A substantial portion of the outer surface of the body is adapted to be stationary with respect to the gastric wall at the above position between the patient's diaphragm and the lower portion of the wall of the indented gastric fundus. Preferably, the body is made of a material that is softer than Shore hardness 25 or 15. According to a preferred embodiment of the device, the proximal portion of the movement restriction device is adapted to be at least partially indented by the wall of the patient's gastric fundus and has a body adapted to have an outer surface containing a biocompatible material. A substantial portion of the outer surface of the body is adapted to be stationary with respect to the gastric wall at the above position between the patient's diaphragm and the lower portion of the wall of the indented gastric fundus. Preferably, the body is made of a material that is softer than Shore hardness 25 or 15. According to a preferred embodiment of the device, the proximal portion of the movement restriction device is adapted to be at least partially indented by the wall of the patient's gastric fundus and has a body adapted to have an outer surface containing a biocompatible material. A substantial portion of the outer surface of the body is adapted to be stationary with respect to the gastric wall at the above position between the patient's diaphragm and the lower portion of the wall of the indented gastric fundus. Preferably, the body is made of a material that is softer than Shore hardness 25 or 15. According to a preferred embodiment of the device, the proximal portion of the movement restriction device is adapted to be at least partially indented by the wall of the patient's gastric fundus and has a body adapted to have an outer surface containing a biocompatible material. A substantial portion of the outer surface of the body is adapted to be stationary with respect to the gastric wall at the above position between the patient's diaphragm and the lower portion of the wall of the indented gastric fundus. Preferably, the body is made of a material that is softer than Shore hardness 25 or 15. According to a preferred embodiment of the device, the proximal portion of the movement restriction device is adapted to be at least partially indented by the wall of the patient's gastric fundus and has a body adapted to have an outer surface containing a biocompatible material. A substantial portion of the outer surface of the body is adapted to be stationary with respect to the gastric wall at the above position between the patient's diaphragm and the lower portion of the wall of the indented gastric fundus. Preferably, the body is made of a material that is softer than Shore hardness 25 or 15. According to a preferred embodiment of the device, the proximal portion of the movement restriction device is adapted to be at least partially indented by the wall of the patient's gastric fundus and has a body adapted to have an outer surface containing a biocompatible material. A substantial portion of the outer surface of the body is adapted to be stationary with respect to the gastric wall at the above position between the patient's diaphragm and the lower portion of the wall of the indented gastric fundus. Preferably, the body is made of a material that is softer than Shore hardness 25 or 15.

[0026] According to a first schematic design of the body, the body has a maximum perimeter as seen in a plane perpendicular to the axis passing through the body. The perimeter of the body as seen in another plane perpendicular to the above axis is the maximum. According to a first schematic design of the body, the body has a maximum perimeter as seen in a plane perpendicular to the axis passing through the body. The perimeter of the body as seen in another plane perpendicular to the above axis is the maximum. It is equal around or decreases in the direction starting from the maximum circumference along the axis. For example, The body may be substantially oval, spherical, or a substantially oval or curved oval with a depressed central section. It may be oval.

[0027] According to a second schematic design of the body, the circumference of the body as seen in a plane perpendicular to the axis passing through the body increases and decreases at least twice or decreases and increases at least once as the plane is displaced along the axis. For example, the body may be substantially kidney-shaped. increases as the plane is displaced along the axis. For example, the body may be substantially kidney-shaped. increases as the plane is displaced along the axis. For example, the body may be substantially kidney-shaped.

[0028] Preferably, the body is sized to be larger than the outlet of the intestinal tract from the stomach. The body may have a minimum outer diameter of 30 mm or 40 mm or more, and a minimum outer circumference of 150 mm 110 mm, 90 mm, 70 mm, 50 mm or 30 mm.

[0029] Preferably, the body has a rounded contour without overly sharp edges that would damage the patient's gastric wall and generally has a smooth outer surface that rests against the wall at the base. has a rounded contour without overly sharp edges that would damage the patient's gastric wall and generally has a smooth outer surface that rests against the wall at the base.

[0030] The body is implantable inside or outside the patient's stomach and is adapted to be attached to the patient's gastric wall surgically. The body may be deformable to take an elongated shape with a diameter smaller than the diameter of the trocar used in laparoscopy, whereby the body can be pushed or pulled through the trocar when deformed into the elongated shape as described above. the body can be pushed or pulled through the trocar when deformed into the elongated shape as described above. The body defines a flexible outer chamber filled with a fluid such as a gel. It may include a wall so that the body can pass through the trocar as described above. Alternatively, the body may include a compressible elastic material that enables the body to pass through the trocar.

[0031] The body may be hollow and adapted to be inserted into the hollow body and further adapted to be combined to form a single piece inside the body. It may include at least two separate pieces so that the body can pass through the trocar used in laparoscopy. Alternatively, the body may have an outer wall and a hollow inner compressive portion for being filled with fluid or gel after being inserted into the patient's body.

[0032] The body may have a chamber with an injection port, and the chamber of the body is filled with fluid through the injection port.

[0033] The body can have at least one holding device adapted to be used to push or pull the body through the trocar used in laparoscopy. This holding device is adapted to hold an additional portion of the body adapted to be held by a surgical instrument. More specifically, this holding device is adapted to hold a thread or band inserted through the holding device. When the body has an outer wall, the holding device is at least partially disposed inside the outer wall of the body.

[0034] In one embodiment, the device according to the present invention further has an adjustment device for adjusting at least the proximal portion of the movement restriction device. For this purpose, the movement restriction device is hydraulically ​​​​​​​​​​​​ It may have a body whose size can be adjusted, and the adjustment device may have a hydraulic fluid reservoir that is connected to the body when implanted into a patient. In this case, the size of the body is non-invasively adjusted by manually pressing the hydraulic fluid reservoir, whereby the amount of hydraulic fluid supplied to the body and further the size of the body are adjusted. The device may further have a hydraulic adjustment device including at least one chamber that is recessed into the patient's gastric wall and connected to the body when implanted into the patient. Here, the amount of hydraulic fluid accommodated in the body is non-invasively adjusted 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 into the patient, thereby expanding the more basal wall to give the patient a feeling of fullness. Also, the adjustment device can further have a reverse servo, wherein when a small amount of fluid in the reservoir is compressed with a strong force, the chamber moves a larger total amount with a smaller force per unit volume. In one embodiment, the body forms a first chamber and further has at least one additional body forming a second chamber smaller than the first chamber, and these first and second chambers are connected to each other and preferably in fluid communication with each other. The hydraulic reservoir is preferably adapted to be disposed subcutaneously in the patient and preferably adapted to be disposed on the patient's abdomen. The hydraulic reservoir may have a wall defining its volume, and the volume of the hydraulic reservoir is adjusted by moving a wall portion of the wall of the hydraulic reservoir. The device has a means for moving the wall portion for moving the wall portion. wherein when a small amount of fluid in the reservoir is compressed with a strong force, the chamber moves a larger total amount with a smaller force per unit volume. and the chamber moves a larger total amount with a smaller force per unit volume. In one embodiment the body forms a first chamber and further has at least one additional body forming a second chamber smaller than the first chamber, and these first and second chambers are connected to each other and preferably in fluid communication with each other. The hydraulic reservoir is preferably adapted to be disposed subcutaneously in the patient and preferably adapted to be disposed on the patient's abdomen. The hydraulic reservoir may have a wall defining its volume, and the volume of the hydraulic reservoir is adjusted by moving a wall portion of the wall of the hydraulic reservoir. The device has a means for moving the wall portion for moving the wall portion. reservoir may have a wall defining its volume, and the volume of the hydraulic reservoir is adjusted by moving a wall portion of the wall of the hydraulic reservoir. The device has a means for moving the wall portion for moving the wall portion. It can have a motor. The hydraulic adjustment device can have a pump, and the hydraulic reservoir is adjusted by the pump pushing fluid between the hydraulic reservoir and the at least one chamber. A mechanical device that is moved when the hydraulic adjustment device is actuated 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 have a motor for mechanically adjusting the movement restriction device. The hydraulic reservoir is adjusted by the pump pushing fluid between the hydraulic reservoir and the at least one chamber. A mechanical device that is moved when the hydraulic adjustment device is actuated 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 have a motor for mechanically adjusting the movement restriction device.

[0035] In one embodiment, the device according to the present invention further has a second body for filling the volumes of two different parts of the patient's stomach when implanted into the patient together with the main body, thereby affecting the patient's reflux. This reflux disease treatment device is adapted to be adjusted non-invasively after surgery, and is also adapted to be adjusted over time such that initially one filling body fills the volume of one part of the stomach and then the other filling body fills the volume of the other part of the stomach. The device according to the present invention further has a second body for filling the volumes of two different parts of the patient's stomach when implanted into the patient together with the main body, thereby affecting the patient's reflux. This reflux disease treatment device is adapted to be adjusted non-invasively after surgery, and is also adapted to be adjusted over time such that initially one filling body fills the volume of one part of the stomach and then the other filling body fills the volume of the other part of the stomach. This reflux disease treatment device is adapted to be adjusted non-invasively after surgery, and is also adapted to be adjusted over time such that initially one filling body fills the volume of one part of the stomach and then the other filling body fills the volume of the other part of the stomach.

[0036] In one embodiment, the device according to the present invention has an adjustment device for adjusting the size and / or 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. The size of the movement restriction device 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 regarded as the main body. The device includes at least one chamber that penetrates into the patient's stomach wall and is connected to the main body when implanted in the patient together with the main body. In one embodiment, the device according to the present invention has an adjustment device for adjusting the size and / or 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. 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. The size of the movement restriction device 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 regarded as the main body. The device includes at least one chamber that penetrates into the patient's stomach wall and is connected to the main body when implanted in the patient together with the main body. It may further have a hydraulic regulation device, where the amount of hydraulic fluid contained in the body is non-invasively regulated by distributing the fluid between a hydraulic reservoir and at least one chamber. 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 adjustment device can have a reverse servo including three adjustable reservoirs with hydraulic fluid, where a small amount of fluid in a first reservoir disposed subcutaneously, which is part of a first closed system including the second reservoir, is compressed with a strong force per unit area to move a small amount of hydraulic fluid, and the second reservoir acts on a large amount of hydraulic fluid in a third reservoir, which is part of a second closed system having a larger volume than the first reservoir described above, thereby being able to move a larger total amount of hydraulic fluid with a weak force per unit area.

[0037] In certain embodiments, the movement restoration device outlined above is assembled to create a sized-adjustable implantable modular movement restriction device that includes at least the proximal portion of a movement restriction device and has two or more movement restriction device segments adapted to be assembled, preferably having three or more segments. This modular movement restriction device is adapted to rest with at least a portion of its outer surface facing the base wall of the patient's stomach at a position between the patient's diaphragm and the base wall, such that when the movement restriction device is implanted in the patient, the cardiac incisure of the patient's and the cardia is prevented from sliding through the diaphragm of the patient whose cardia is open into the patient's chest cavity , and the support pressure on the patient's cardiac sphincter extending from the patient's abdomen is maintained. This assembled type movement restriction device is preferably located between the diaphragm and the wall of the base, at least It is adapted to disassemble into a plurality of segments when separated from the implantation position of the wall of the gastric fundus that is partially contracted. Preferably, the assembled type movement restriction device is adapted to be recessed into the gastric wall and further, when separated from the implantation position of the stomach, including the position passing through the stomach to hold the position inside the stomach It is adapted to disassemble into a plurality of segments. These segments are preferably adapted to pass individually through the food passage, thereby reducing the risk of closed-loop syndrome / intestinal obstruction occurring in the patient's intestine . The movement restriction device segment can be adapted to pass through a trocar for assembly and for implanting the movement restriction device into the abdominal cavity. The movement restriction device segment can have a flexible outer shape adapted to pass through a trocar . The movement restriction device segment can be adapted to have a shape such that it can be assembled to form 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 can be adapted to be filled with at least one fluid, foam, gel , or a fluid that hardens into a solid material. In one embodiment , the movement restriction device segment is solid. The movement restriction device segment is preferably adapted to temporarily hold their assembled positions by the indented gastric wall or alternatively by an adhesive .

[0038] The movement restriction device has at least one assembly element that fits well with at least one assembly element of another segment for assembly, and by fitting the assembly elements, more segments can be assembled, thereby creating a transplantable movement restriction device. For this purpose, the segment preferably includes one core part and a plurality of outer parts. Preferably, at least one assembly element is a flange and a slit selected. The core part is adapted to receive and assemble the outer elements to create a transplantable movement restriction device. Preferably, the core part has an assembly slit adapted to receive the corresponding assembly flange of the outer part during the assembly of the movement restriction device. In one embodiment, the slit is arranged around the outer peripheral region of the core part. 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 prevents each of the movement restriction devices from moving relative to the core part along a first plane, and the movement restriction device and the core part further have a second assembly element that prevents each segment and the core part from moving along a second plane angled with respect to the first plane when the segment and the core part are assembled. For example, the first plane and the second plane may be substantially perpendicular. The second assembly element preferably has mating elements with complementary protrusions and recesses provided on the movement restriction device segment and the core part, and at least one assembly element further has protrusions and recesses. Preferably, at least one assembly element... ... ... ... ... ... The element includes an assembly slit within the core portion and an assembly flange within the segment, and mates The element includes a protrusion within the slit and a recess within the flange. Alternatively , at least one assembly element includes an assembly flange within the core portion and an assembly slit within the segment, and the mating element includes a protrusion within the slit and a recess within the flange .

[0039] In a particular embodiment, the device preferably further has a guiding device operable to assemble the movement restriction device segment onto a transplantable movement restriction device. Preferably , this guiding device is an operating wire operably connected to the segment.

[0040] The operating wire may be made of a biodegradable material that contacts the body fluid within the abdominal cavity to facilitate disassembling the movement restriction device into a plurality of segments. To assist with the assembly procedure, each segment may be provided with at least one assembly element that fits well with at least one assembly element of another segment, and by fitting the assembly elements, a plurality of segments can be assembled, thereby creating a transplantable movement restriction device. In one embodiment, the segment includes one core portion and a plurality of outer portions, and in one embodiment , the assembly element is selected from a flange and a slit that fit well.

[0041] The core portion is preferably adapted to receive and assemble outer elements to create a transplantable movement restriction device. In one embodiment, the core portion has an assembly slit adapted to receive the corresponding assembly flange of the outer portion during assembly of the movement restriction device ​​This is done. Preferably, the slits are arranged around the outer peripheral region of the core portion. These slits and the flange integrally hold a plurality of segments in their implantation positions as a movement restriction device and further assist in disassembling the movement restriction device in case the movement restriction device accidentally moves away from its position and enters, for example, the gastric cavity. They can be designed to form a clearance fit adapted to assist in disassembling the movement restriction device in such a case. In such a case, deterioration of the guiding device or disassembling the movement restriction device into a plurality of segments designed so as not to cause any stricture or otherwise harm the patient in any way also helps. To assemble the plurality of segments, operating wires are connected to the core portion and the outer portion, and 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 portion, and it is preferable that at least one operating channel for receiving the operating wire is provided in the core portion. Preferably, each outer portion is connected to two operating channels by the 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. When the operating wire received in the first operating channel is displaced in a direction starting from the end face, the first outer portion is assembled to the core portion. The second operating channel has two orifices in the second slit of the core portion, and when the operating wire connected to the first operating channel is displaced in a direction starting from the end face, the second outer portion is assembled to the core portion.

[0042] To assemble the plurality of segments, operating wires are connected to the core portion and the outer portion, and 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 portion, and it is preferable that at least one operating channel for receiving the operating wire is provided in the core portion. Preferably, each outer portion is connected to two operating channels by the 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. When the operating wire received in the first operating channel is displaced in a direction starting from the end face, the first outer portion is assembled to the core portion. The second operating channel has two orifices in the second slit of the core portion, and when the operating wire connected to the first operating channel is displaced in a direction starting from the end face, the second outer portion is assembled to the core portion. it is preferable that at least one operating channel for receiving the operating wire is provided in the core portion. Preferably, each outer portion is connected to two operating channels by the 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. When the operating wire received in the first operating channel is displaced in a direction starting from the end face, the first outer portion is assembled to the core portion. The second operating channel has two orifices in the second slit of the core portion, and when the operating wire connected to the first operating channel is displaced in a direction starting from the end face, the second outer portion is assembled to the core portion. it is preferable that at least one operating channel for receiving the operating wire is provided in the core portion. Preferably, each outer portion is connected to two operating channels by the 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. When the operating wire received in the first operating channel is displaced in a direction starting from the end face, the first outer portion is assembled to the core portion. The second operating channel has two orifices in the second slit of the core portion, and when the operating wire connected to the first operating channel is displaced in a direction starting from the end face, the second outer portion is assembled to the core portion. 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. When the operating wire received in the first operating channel is displaced in a direction starting from the end face, the first outer portion is assembled to the core portion. The second operating channel has two orifices in the second slit of the core portion, and when the operating wire connected to the first operating channel is displaced in a direction starting from the end face, the second outer portion is assembled to the core portion. When the operating wire received in the first operating channel is displaced in a direction starting from the end face, the first outer portion is assembled to the core portion. The second operating channel has two orifices in the second slit of the core portion, and when the operating wire connected to the first operating channel is displaced in a direction starting from the end face, the second outer portion is assembled to the core portion. The second operating channel has two orifices in the second slit of the core portion, and when the operating wire connected to the first operating channel is displaced in a direction starting from the end face, the second outer portion is assembled to the core portion. When the operating wire connected to the first operating channel is displaced in a direction starting from the end face, the second outer portion is assembled to the core portion. . Preferably, the guide wire protrudes from the orifice of the first channel, and thus, can be operated by an instrument for displacing the guide wire and the first outer element, whereby , its assembly flange is fitted into a specified first assembly slit on the core element, and in a similar manner, the remaining outer elements are displaced in a predetermined order, and a transplantable movement restriction device is assembled. The segment may include three or more outer portions assembled to specified slits of the core portion, and the guide wire passes through an operating channel having an orifice in each of the specified slits of the core portion. In one embodiment, the movement restriction device has one core portion and four outer portions. However, those skilled in the art can also design the segment in other forms within the scope of the present invention. The movement restriction device assembled in this way can generally maintain a spherical shape, but as will be described later, other shapes and additional functional elements may be made as part of the present invention. In the following description of the subparts, another feature of the proximal part of this movement restriction device will be described. These features can be combined with any of the following features related to the distal part of the movement restriction device.

[0043] Here, in a further advantageous embodiment of a device adapted to treat obesity, the body is size-adjustable and is inserted into the gastric wall at the base of the patient. As a result, the body expands the wall of the patient's gastric base when its size is increased, thereby giving a feeling of fullness to patients suffering from obesity. At least two transplantable and adjustable expansion devices may be provided to expand another part of the patient's gastric wall, thereby efficiently affecting the patient's appetite.

[0044] ​ Obesity can be treated by providing these two expansion devices. These two expansion devices are preferably regulated from outside the patient's body, such that, initially, the first expansion device is regulated to expand the first portion of the patient's stomach wall, and then the second expansion device is regulated to expand the second portion of the patient's stomach wall.

[0045] Since patients commonly suffer from both obesity and reflux disease, the device of the present invention can be further adapted to treat obesity together with reflux disease in any of the forms outlined above. For this purpose, 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.

[0046] According to a first option, the distal portion of the movement restriction device is adapted to be arranged inside the stomach in a stationary state with the outer surface of the distal portion facing the inside of the stomach wall.

[0047] According to a second option, the distal portion of the movement restriction device is adapted to be arranged outside the stomach in a stationary state with the outer surface of the volume filling device facing the outside of the stomach wall.

[0048] Preferably, the distal portion of the movement restriction device is adapted to be completely indented by the patient's stomach wall and arranged inside or outside the stomach wall via a gastroscopic instrument. For this purpose, the distal portion of the movement restriction device may have a mounting device adapted to cooperate with a grasping instrument. Preferably, the distal portion of the movement restriction device is adapted to be adjusted non-invasively postoperatively.

[0049] The device is adapted to be involved in fixing the distal portion of the movement restriction device to the gastric wall and may have one fixing device, preferably two or more fixing devices. The distal portion of the movement restriction de vice may have one holding device, preferably two or more holding devices, adapted to be held by an instrument to facilitate the implantation of the device.

[0050] At least a part of the distal portion of the movement restriction device may be made of a material that is not decomposed by gastric acid. The distal portion of the movement restriction device may be decomposable by an acid such as hydrochloric acid.

[0051] In one embodiment, the distal portion of the movement restriction device is inflatable to an expanded state and has a surrounding wall defining a chamber, and the distal portion of the movement restriction device is inflated by a gel or fluid supplied into the chamber. To supply the gel or fluid to the chamber, at least one tube may be connected to the distal portion of the movement restriction device. An injection port connectable to the tube may be provided. Alternatively, an inlet port for a fluid or gel connectable to a gastroscopy instrument may be provided on the distal portion of the movement restriction device, where the inlet port has a fluidic connection portion adapted to interconnect the inflatable device and the gastroscopy instrument.

[0052] The distal portion of the movement restriction device may contain a homogeneous material such as a gel having a shure value of less than 15. This device may also be a solid body.

[0053] At least one of the distal portion and the proximal portion of the movement restriction device is at least partly Optionally, it may have an outer surface that is rigid, elastic or flexible. When the outer surface is rigid, the outer surface can maintain a state where it does not deform even when receiving the forces generated by the movement of the stomach and has a relatively high rigidity. The distal portion of the movement restriction device may include a flexible inelastic material. In this case, the outer surface can maintain a state where it does not deform even when receiving the forces generated by the movement of the stomach and has a relatively high rigidity. According to a first schematic design of the distal portion of the movement restriction device, this device has a maximum perimeter as seen in a plane perpendicular to the axis passing through the device. As seen in another plane perpendicular to the above axis, the perimeter of the device is equal to the maximum perimeter or decreases as seen in a direction starting from the maximum perimeter along the above axis. For example, the device may be substantially oval, spherical, or a substantially oval or curved oval with a depressed central section. Optionally, it may have an outer surface that is rigid, elastic or flexible. When the outer surface is rigid, the outer surface can maintain a state where it does not deform even when receiving the forces generated by the movement of the stomach and has a relatively high rigidity. The distal portion of the movement restriction device may include a flexible inelastic material.

[0054] According to a first schematic design of the distal portion of the movement restriction device, this device has a maximum perimeter as seen in a plane perpendicular to the axis passing through the device. As seen in another plane perpendicular to the above axis, the perimeter of the device is equal to the maximum perimeter or decreases as seen in a direction starting from the maximum perimeter along the above axis. For example, the device may be substantially oval, spherical, or a substantially oval or curved oval with a depressed central section. In this case, the outer surface can maintain a state where it does not deform even when receiving the forces generated by the movement of the stomach and has a relatively high rigidity. According to a first schematic design of the distal portion of the movement restriction device, this device has a maximum perimeter as seen in a plane perpendicular to the axis passing through the device. As seen in another plane perpendicular to the above axis, the perimeter of the device is equal to the maximum perimeter or decreases as seen in a direction starting from the maximum perimeter along the above axis. For example, the device may be substantially oval, spherical, or a substantially oval or curved oval with a depressed central section. For example, the device may be substantially oval, spherical, or a substantially oval or curved oval with a depressed central section. Optionally, it may have an outer surface that is rigid, elastic or flexible. When the outer surface is rigid, the outer surface can maintain a state where it does not deform even when receiving the forces generated by the movement of the stomach and has a relatively high rigidity. The distal portion of the movement restriction device may include a flexible inelastic material. Optionally, it may have an outer surface that is rigid, elastic or flexible. When the outer surface is rigid, the outer surface can maintain a state where it does not deform even when receiving the forces generated by the movement of the stomach and has a relatively high rigidity. The distal portion of the movement restriction device may include a flexible inelastic material.

[0055] According to a second schematic design of this device, the perimeter of the device as seen in a plane perpendicular to the axis passing through the device increases and then decreases at least twice or decreases and then increases at least once as the plane is displaced along the above axis. For example, the device may be substantially kidney-shaped. In this case, the outer surface can maintain a state where it does not deform even when receiving the forces generated by the movement of the stomach and has a relatively high rigidity. According to a second schematic design of this device, the perimeter of the device as seen in a plane perpendicular to the axis passing through the device increases and then decreases at least twice or decreases and then increases at least once as the plane is displaced along the above axis. For example, the device may be substantially kidney-shaped. For example, the device may be substantially kidney-shaped.

[0056] 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 an elongated shape, a circular shape, a bent shape and / or a curved shape.

[0057] 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 has a perimeter of at least 30 mm, 50 mm, 80 mm, 120 mm, 150 mm, 180 mm or 220 mm.

[0058] The distal portion of the movement restriction device is from 0.0001 m 3 to 0.001 m3 or 0.0 0001 m 3 to 0.001 m 3 or 0.00001 m 3 to 0.0002 m 3 in the range and has a volume. The volume of the volume filling device is less than 0.0002 m 3 .

[0059] The distal portion of the movement restriction device may have at least two interconnectable parts adapted to be placed inside or outside the stomach as a separated part .

[0060] The distal portion of the movement restriction device may contain an elastic material, a biocompatible material and / or silicon . Preferably, at least one layer is provided on at least one of the distal and proximal portions of the movement restriction device. For example, there is a metal layer, a parylene layer, a polytetra fluoroethylene layer or a polyurethane layer. These layers may include multiple layers in any order . Preferably, one of these layers may be made of metal, silicon or PTFE . The volume filling device may have an outer surface layer of silicon, polyurethane, Teflon® i.e. polytetrafluoroethylene, metal, parylene, PTFE, or a combination thereof . The volume filling device may have an inner surface layer of silicon, polyurethane, Tef lon® i.e. polytetrafluoroethylene, metal, parylene, PTFE , or a combination thereof. Another combination of layers includes an inner surface layer of polytetra fluoroethylene and an outer layer of silicon, an inner layer of polytetrafluoroethylene and an intermediate layer of silicon and an outer layer of parylene, an inner layer of polyurethane and si licon and an outer layer of parylene, an inner layer of polyurethane and si The outer layer of the recon, as well as the inner surface layer of polyurethane, the intermediate layer of silicon, and the outer layer of the relen are included.

[0061] The distal portion of the movement restriction device is adapted to transform into a solid phase, i.e., a fixed form, and may contain a fluid. This fluid may be a liquid polyurethane, i.e., may be isosmotic. This fluid may contain macromolecules such as iodine molecules to prevent diffusion.

[0062] The distal portion of the movement restriction device may have a maximum circumference of at least 50 millimeters, preferably at least 8 0 millimeters. Preferably, the distal portion of the movement restriction device is deformable to a maximum diameter, thereby enabling insertion into a laparoscopic trocar.

[0063] Preferably, the distal portion of the movement restriction device is adapted to be maintained in a fixed position by a gastric-gastric suture or staple for inserting the device into the gastric wall. Advantageously, the distal portion of the movement restriction device has a changing circumference so as to be better maintained in a fixed position when inserted into the patient's gastric wall. The gastric-gastric suture or staple is provided with a fixing portion that forms a structure adapted to contact the gastric wall to promote the internal growth of human tissue and fix the position of the volume filling device attached to the gastric wall for a long time. This structure may include a net-like structure.

[0064] In an embodiment of the present invention, the device has an expansion device disposed outside the gastric wall and adapted to expand a portion of the gastric wall to affect the patient's appetite. The volume filling device When it is inflatable, the device may have a fluid connection that interconnects the expansion device and the volume filling device. It may have a dynamic connection.

[0065] The expansion device can be hydraulically adjusted. In this case, a subcutaneously implantable hydraulic reservoir may be provided that is connected to the hydraulically adjustable expansion device, such that the hydraulically adjustable expansion device is adapted to be non-invasively adjusted using fluid from the hydraulic reservoir when implanted within a patient. In one embodiment, the hydraulically adjustable expansion device is non-invasively adjusted by manually pressing on the hydraulic reservoir. Further, the movement restriction device preferably has an inflatable body, and further includes a pump and a chamber in fluid contact with the inflatable body, and the pump adjusts the hydraulic reservoir by extruding fluid or air from the body into the chamber. It may be provided with a subcutaneously implantable hydraulic reservoir connected thereto, so that when the hydraulically adjustable expansion device is implanted in the patient, it is adapted to be non-invasively adjusted using the fluid from the hydraulic reservoir. It is adapted to be non-invasively adjusted using fluid from the hydraulic reservoir when the hydraulically adjustable expansion device is implanted in the patient. In one embodiment, the hydraulically adjustable expansion device is non-invasively adjusted by manually pressing on the hydraulic reservoir. The hydraulically adjustable expansion device is non-invasively adjusted by manually pressing on the hydraulic reservoir. The movement restriction device preferably has an inflatable body, and further includes a pump and a chamber in fluid contact with the inflatable body, and the pump adjusts the hydraulic reservoir by extruding fluid or air from the body into the chamber. The movement restriction device preferably has an inflatable body, and further includes a pump and a chamber in fluid contact with the inflatable body, and the pump adjusts the hydraulic reservoir by extruding fluid or air from the body into the chamber. The pump adjusts the hydraulic reservoir by extruding fluid or air from the body into the chamber.

[0066] The device may have an implantable stimulation device that sends stimulation pulses to the esophageal sphincter, particularly the gastroesophageal sphincter, to stimulate the esophageal sphincter and thereby further close the gastroesophageal junction and additionally prevent reflux disease. The device may have an implantable stimulation device that sends stimulation pulses to the esophageal sphincter, particularly the gastroesophageal sphincter, to stimulate the esophageal sphincter and thereby further close the gastroesophageal junction and additionally prevent reflux disease. This stimulation device is composed of at least one conductor and at least one electrode bar that receives the stimulation pulses and applies those stimulation pulses to the gastroesophageal sphincter to stimulate the gastroesophageal sphincter. This stimulation device is composed of at least one conductor and at least one electrode bar that receives the stimulation pulses and applies those stimulation pulses to the gastroesophageal sphincter to stimulate the gastroesophageal sphincter. This at least one electrode bar is also maintained in a fixed position by being sutured by a gastroesophageal suture or by being inserted into the gastric wall. This at least one electrode bar is also maintained in a fixed position by being sutured by a gastroesophageal suture or by being inserted into the gastric wall. The stimulation pulses may be sent as a series of pulses, with a pulse train being repeated across a time break, and this break is between each pulse train of the pulse train. The stimulation pulses may be sent as a series of pulses, with a pulse train being repeated across a time break, and this break is between each pulse train of the pulse train. Extend the break between pulses. Preferably, the stimulation device delivers a plurality of pulse trains consecutively, and then a break longer than the break between pulse trains is placed to keep the muscle at rest and maintain the state where the esophageal sphincter is 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 has at least one sensor for sensing the physical parameters of the patient or the functional parameters of the movement restriction device, and an internal control unit for controlling the stimulation device.

[0067] Normally, the internal control unit controls the stimulation device in response to the information from the sensor. A sensor for sensing the contraction wave of the esophagus or any other parameter related to the ingested food sends information to the internal control unit, and then the internal control unit stops the stimulation in response to such information from the sensor. The stimulation device can always be controlled by the patient.

[0068] This object is also achieved by providing an apparatus including a transplantable movement restriction device that is elongated and has a proximal portion and a distal portion when implanted in the patient,

[0069] where the proximal portion is adapted to be at least partially indented by the wall of the patient's gastric fundus, has an outer surface preferably including a biocompatible material, and here, a substantial portion of the outer surface of the proximal portion of the movement restriction device is between the patient's diaphragm and the wall of the indented gastric fundus and then the internal control unit stops the stimulation in response to such information from the sensor.

[0070] The stimulation device can always be controlled by the patient.

[0071] This object is also achieved by providing an apparatus including a transplantable movement restriction device that is elongated and has a proximal portion and a distal portion when implanted in the patient, where the proximal portion is adapted to be at least partially indented by the wall of the patient's gastric fundus, has an outer surface preferably including a biocompatible material, and here, a substantial portion of the outer surface of the proximal portion of the movement restriction device is between the patient's diaphragm and the wall of the indented gastric fundus and has an outer surface preferably including a biocompatible material, and here, a substantial portion of the outer surface of the proximal portion of the movement restriction device is between the patient's diaphragm and the wall of the indented gastric fundus so as not to damage the gastric wall at a position between at least a part of the lower part thereof is adapted to rest facing the gastric wall, so that when the movement restriction device is indented the cardiac incisure of the patient's stomach is restricted from moving towards the patient's diaphragm, and thereby preventing the cardiac orifice from sliding through the patient's diaphragm that is open into the patient's thoracic cavity, and maintaining the support pressure on the patient's cardiac sphincter extending from the patient's abdomen. The distal portion of the movement restriction device stabilizes and holds the proximal portion and is also adapted to be substantially indented into the gastric wall. The gastric wall at the base can move more easily and is thus stabilized by the distal portion that is at least partially indented into the gastric wall below the base of the gastric wall. The proximal portion of the movement restriction device has a size of at least 125 mm and a perimeter of at least 15 mm, and further has a transplantable stimulation device adapted to engage the patient's cardiac sphincter and a control device for controlling the stimulation device to stimulate the cardiac sphincter. Here, the stimulation of the cardiac sphincter is created by an energy pulse for strengthening the tone of the sphincter so that the cardiac orifice is closed, and the control device is operable by the patient and can thus be set to stop. Here, the control device is further operable by the patient to set the stimulation device to an operating state, and in this operating state, the stimulation device continuously alternates between an operating mode in which the cardiac sphincter is stimulated by the above energy pulse and a rest mode in which the cardiac sphincter is not stimulated when the patient is not swallowing. (Movement restriction device) and is adapted to be indented into the gastric wall The distal portion, which is at least partially indented into the gastric wall below the base of the gastric wall stabilizes the gastric wall at the base, which can move more easily 3 The proximal portion of the movement restriction device has a size of at least 125 mm and a perimeter of at least 15 mm, and is further adapted to engage the patient's cardiac sphincter and has a transplantable stimulation device for stimulating the cardiac sphincter and a control device for controlling the stimulation device Here, the stimulation of the cardiac sphincter is created by an energy pulse for strengthening the tone of the sphincter so that the cardiac orifice is closed and the control device is operable by the patient and can thus be set to stop Here, the control device is further operable by the patient to set the stimulation device to an operating state In this operating state, the stimulation device continuously alternates between an operating mode in which the cardiac sphincter is stimulated by the above energy pulse when the patient is not swallowing and a rest mode in which the cardiac sphincter is not stimulated The control device is further operable by the patient to set the stimulation device to an operating state In this operating state, the stimulation device continuously alternates between an operating mode in which the cardiac sphincter is stimulated by the above energy pulse and a rest mode in which the cardiac sphincter is not stimulated when the patient is not swallowing.

[0072] (Movement restriction device) A movement limiting device for the device is described. In this context, the movement limiting device is described here together with All features, functions or conformities described herein relate to the proximal portion even if not expressly stated. However, it should be understood that all of the features, embodiments, and aspects described herein are intended to be included in the present invention. The aspects or parts of the embodiments, as well as any methods, may be implemented in a device, if applicable. It may be used on both the proximal or distal portions of the

[0073] The apparatus includes an implantable movement limiting device having an outer surface comprising a biocompatible material; Here, the movement restriction device is positioned between the patient's diaphragm and fundus wall. At least a portion of the outer surface is adapted to rest against the wall of the patient's stomach fundus. This limits the cardiac notch of the patient's stomach from moving toward the patient's diaphragm. The resulting apparatus is for treating gastroesophageal reflux disease. 5mm 3 and a circumference of at least 15 mm, and It restricts the movement of the esophagus toward the diaphragm, thereby preventing the cardia from opening into the patient's thorax. The catheter is prevented from sliding through the patient's diaphragm, which extends from the patient's abdomen, and the patient's cardia, which extends from the patient's abdomen. Supportive pressure against the sphincter is maintained. The fixation device holds the movement restriction device in place. The device is adapted to be fixed to the

[0074] The outer surface of the implanted movement restriction device is adapted to rest against the fundus wall. As a result, the fundus is less fragile than the esophagus, and complications such as widespread tissue damage may occur. The risk of

[0075] In the first embodiment of the present invention, the fixation device fixes the movement restriction device in the above position by integrally connecting a plurality of portions of the gastric wall at the base surrounding the movement restriction device with sutures or staples. That is, the movement restriction device is at least partially disposed within the recessed space . Thus, by indirectly attaching the movable movement restriction device in this manner, suturing between the movement restriction device and the tissue is eliminated, and the risk of complications is further reduced. By maintaining the movement restriction device in a fixed position in this manner, an elastic suspension with improved long-term characteristics is formed .

[0076] Fixation devices such as sutures or staples can integrally connect a plurality of portions of the gastric wall at the base to substantially or completely insert the movement restriction device from either the inside or the outside of the patient's gastric wall . When the movement restriction device is disposed outside the patient's gastric wall , the movement restriction device is indented by the gastric wall at the base, and the gastric lumen is substantially reduced by a volume substantially exceeding the volume of the movement restriction device .

[0077] In another embodiment of the present invention, the fixation device includes a first implantable fixation device that attaches the movement restriction device in the above position to the wall at the base , a second fixation device that brings the movement restriction device close to the angle of His of the patient and indirectly or directly fixes it to the esophagus , and a third fixation device that indirectly or directly fixes the movement restriction device to the patient's diaphragmatic muscle or related muscles . Any of the first, second, and third fixation devices may be composed of a plurality of sutures or staples. The first fixation device keeps the movement restriction device in a long-term ​​It may have a structure that promotes tissue growth for attachment to the gastric wall over a period of time. Tissue The structure that promotes tissue growth may be sutured to the gastric wall with a relatively large contact surface facing the stomach Since the surface of this structure such as a net is relatively large, it becomes possible to cause human tissue to grow internally in order to hold the movement restriction device in a fixed position over a long period of time. The structure that promotes tissue growth may have sutures or staples for attaching the net-like structure to the gastric wall at the base. In addition to inserting the movement restriction device according to the first embodiment of the present invention, a second fixing device may be used to indirectly or directly fix the movement restriction device to the esophagus by bringing it closer to the His angle of the patient, and a third fixing device may be used to indirectly or directly fix the movement restriction device to the diaphragmatic muscle or another muscle tissue of the patient.

[0078] At least a part of the movement restriction device may be made of a material that can be destroyed by gastric acid or that is not destroyed by gastric acid. The movement restriction device is expandable and adapted to be expanded using a gel or fluid. A fluid or gel containing portion for containing the fluid for expanding the movement restriction device may be provided. The movement restriction device may include a homogeneous material and may be a solid body. The movement restriction device may include an enclosing wall that defines a chamber.

[0079] The movement restriction device may have a rigid, elastic or flexible outer side. When the outer side is rigid

[0080] The movement restriction device is expandable and adapted to be expanded using a gel or fluid. A fluid or gel containing portion for containing the fluid for expanding the movement restriction device may be provided. The movement restriction device may include a homogeneous material and may be a solid body. The movement restriction device may include an enclosing wall that defines a chamber.

[0081] The movement restriction device may include a homogeneous material and may be a solid body.

[0082] The movement restriction device may include an enclosing wall that defines a chamber.

[0083] The movement restriction device may have a rigid, elastic or flexible outer side. When the outer side is rigid​ In some cases, the outer wall maintains a state of not deforming even when receiving the force generated by the movement of the stomach. It has a relatively high rigidity so as to be able to do so. When the movement restriction device is indented, according to the first embodiment described above, the movement restriction device is preferably at least partially indented by the wall of the gastric fundus of the patient and has an outer surface containing a biocompatible material. It has a body adapted to be like this. A fairly large part of the outer surface of the body faces and is adapted to rest against the gastric wall at the above position between the patient's diaphragm and the lower part of the wall of the indented gastric fundus. Preferably, the body is made of a material softer than 25shure or 15shure.

[0084] According to the first schematic design of the body, the body has a maximum circumference as seen in a plane perpendicular to the axis passing through the body. The circumference of the body as seen in another plane perpendicular to the above axis is equal to the maximum circumference or decreases as seen in the direction starting from the maximum circumference along the above axis. For example, the body may be substantially oval, spherical, or a substantially oval or curved oval with a concave central section.

[0085] According to the second schematic design of the body, the circumference of the body as seen in a plane perpendicular to the axis passing through the body increases and then decreases at least twice or decreases and then increases at least once as the plane is displaced along the above axis. For example, the body may be substantially kidney-shaped.

[0086] Preferably, the body is sized to be larger 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 more, and a minimum outer circumference of 150 mm , 110 mm, 90 mm, 70 mm, 50 mm or 30 mm.

[0087] Preferably, the body has a rounded contour without overly sharp edges that could damage the patient's gastric wall and generally has a smooth outer surface that rests against the wall of the base.

[0088] The body is implantable inside or outside the patient's stomach and is adapted to be attached to the patient's gastric wall by surgery. The body may be deformable to have an elongated shape with a diameter smaller than the diameter of the trocar used in laparoscopy, such that the body can be pushed or pulled through the trocar when in the elongated shape as described above. The body may include a flexible outer wall that defines a chamber filled with a fluid such as a gel, such that the body can pass through the trocar as described above. Alternatively, the body may include a compressible elastic material that allows the body to pass through the trocar.

[0089] The body may be hollow and may be adapted to be inserted into the hollow body and further adapted to be combined into at least two separate pieces that become a single unitary piece inside the body, such that the body can pass through the trocar used in laparoscopy. Alternatively, the body may have an outer wall and a hollow compressible inner portion for being filled with a fluid or gel after being inserted into the patient's body.

[0090] The body may have a chamber with an injection port, and the chamber of the body has the injection port It is filled with fluid through.

[0091] The body can have at least one holding device adapted to be pushed or pulled through a trocar used in laparoscopy. This holding device can be adapted to hold an additional part of the body adapted to be held by a surgical instrument. It is adapted to hold. More specifically, this holding device is adapted to hold a thread or band inserted through the holding device. If the body has an outer wall, the holding device is at least partially disposed inside the outer wall of the body. It is adapted to hold. More specifically, this holding device is adapted to hold a thread or band inserted through the holding device. If the body has an outer wall, the holding device is at least partially disposed inside the outer wall of the body. It is adapted to hold. More specifically, this holding device is adapted to hold a thread or band inserted through the holding device. If the body has an outer wall, the holding device is at least partially disposed inside the outer wall of the body. It is at least partially disposed inside the outer wall of the body.

[0092] In an advantageous embodiment, the body is adjustable in size and can be indented into the gastric wall at the base of the patient. As a result, when its size is increased, the body can expand the wall of the patient's gastric base, thereby giving a feeling of fullness to patients who also suffer from obesity. At least two implantable and adjustable expansion devices may be provided to expand another part of the patient's gastric wall, and thereby obesity can be treated by efficiently affecting the patient's appetite. These two expansion devices are preferably adjusted from outside the patient's body, so that first the first expansion device is adjusted to expand the first part of the patient's gastric wall, and then the second expansion device is adjusted to expand the second part of the patient's gastric wall. In an advantageous embodiment, the body is adjustable in size and can be indented into the gastric wall at the base of the patient. As a result, when its size is increased, the body can expand the wall of the patient's gastric base, thereby giving a feeling of fullness to patients who also suffer from obesity. At least two implantable and adjustable expansion devices may be provided to expand another part of the patient's gastric wall, and thereby obesity can be treated by efficiently affecting the patient's appetite. These two expansion devices are preferably adjusted from outside the patient's body, so that first the first expansion device is adjusted to expand the first part of the patient's gastric wall, and then the second expansion device is adjusted to expand the second part of the patient's gastric wall. In an advantageous embodiment, the body is adjustable in size and can be indented into the gastric wall at the base of the patient. As a result, when its size is increased, the body can expand the wall of the patient's gastric base, thereby giving a feeling of fullness to patients who also suffer from obesity. At least two implantable and adjustable expansion devices may be provided to expand another part of the patient's gastric wall, and thereby obesity can be treated by efficiently affecting the patient's appetite. These two expansion devices are preferably adjusted from outside the patient's body, so that first the first expansion device is adjusted to expand the first part of the patient's gastric wall, and then the second expansion device is adjusted to expand the second part of the patient's gastric wall. In an advantageous embodiment, the body is adjustable in size and can be indented into the gastric wall at the base of the patient. As a result, when its size is increased, the body can expand the wall of the patient's gastric base, thereby giving a feeling of fullness to patients who also suffer from obesity. At least two implantable and adjustable expansion devices may be provided to expand another part of the patient's gastric wall, and thereby obesity can be treated by efficiently affecting the patient's appetite. These two expansion devices are preferably adjusted from outside the patient's body, so that first the first expansion device is adjusted to expand the first part of the patient's gastric wall, and then the second expansion device is adjusted to expand the second part of the patient's gastric wall. In an advantageous embodiment, the body is adjustable in size and can be indented into the gastric wall at the base of the patient. As a result, when its size is increased, the body can expand the wall of the patient's gastric base, thereby giving a feeling of fullness to patients who also suffer from obesity. At least two implantable and adjustable expansion devices may be provided to expand another part of the patient's gastric wall, and thereby obesity can be treated by efficiently affecting the patient's appetite. These two expansion devices are preferably adjusted from outside the patient's body, so that first the first expansion device is adjusted to expand the first part of the patient's gastric wall, and then the second expansion device is adjusted to expand the second part of the patient's gastric wall. In an advantageous embodiment, the body is adjustable in size and can be indented into the gastric wall at the base of the patient. As a result, when its size is increased, the body can expand the wall of the patient's gastric base, thereby giving a feeling of fullness to patients who also suffer from obesity. At least two implantable and adjustable expansion devices may be provided to expand another part of the patient's gastric wall, and thereby obesity can be treated by efficiently affecting the patient's appetite. These two expansion devices are preferably adjusted from outside the patient's body, so that first the first expansion device is adjusted to expand the first part of the patient's gastric wall, and then the second expansion device is adjusted to expand the second part of the patient's gastric wall. In an advantageous embodiment, the body is adjustable in size and can be indented into the gastric wall at the base of the patient. As a result, when its size is increased, the body can expand the wall of the patient's gastric base, thereby giving a feeling of fullness to patients who also suffer from obesity. At least two implantable and adjustable expansion devices may be provided to expand another part of the patient's gastric wall, and thereby obesity can be treated by efficiently affecting the patient's appetite. These two expansion devices are preferably adjusted from outside the patient's body, so that first the first expansion device is adjusted to expand the first part of the patient's gastric wall, and then the second expansion device is adjusted to expand the second part of the patient's gastric wall. In an advantageous embodiment, the body is adjustable in size and can be indented into the gastric wall at the base of the patient. As a result, when its size is increased, the body can expand the wall of the patient's gastric base, thereby giving a feeling of fullness to patients who also suffer from obesity. At least two implantable and adjustable expansion devices may be provided to expand another part of the patient's gastric wall, and thereby obesity can be treated by efficiently affecting the patient's appetite. These two expansion devices are preferably adjusted from outside the patient's body, so that first the first expansion device is adjusted to expand the first part of the patient's gastric wall, and then the second expansion device is adjusted to expand the second part of the patient's gastric wall.

[0093] The expansion device can be hydraulically adjusted. In this case, a subcutaneously implantable hydraulic reservoir connected to the hydraulically adjustable expansion device may be provided, so that the hydraulically adjustable expansion device is non-invasively adjusted by manually pressing the hydraulic reservoir. The expansion device can be hydraulically adjusted. In this case, a subcutaneously implantable hydraulic reservoir connected to the hydraulically adjustable expansion device may be provided, so that the hydraulically adjustable expansion device is non-invasively adjusted by manually pressing the hydraulic reservoir. The expansion device can be hydraulically adjusted. In this case, a subcutaneously implantable hydraulic reservoir connected to the hydraulically adjustable expansion device may be provided, so that the hydraulically adjustable expansion device is non-invasively adjusted by manually pressing the hydraulic reservoir. It also preferably has an expandable body, and further has a pump and a chamber in contact with the fluid, and the pump regulates the hydraulic reservoir by pushing fluid or air from the body into the chamber. The device may have an implantable stimulation device that sends stimulation pulses to the esophageal sphincter in order to stimulate the esophageal sphincter and thereby close the esophageal sphincter more tightly to additionally prevent reflux disease. This stimulation device is composed of at least one conductor and at least one electrode bar that applies these stimulation pulses to the esophageal sphincter to stimulate the esophageal sphincter.

[0094] The device may have an implantable stimulation device that sends stimulation pulses to the esophageal sphincter in order to stimulate the esophageal sphincter and thereby close the esophageal sphincter more tightly to additionally prevent reflux disease. This stimulation device is composed of at least one conductor and at least one electrode bar that applies these stimulation pulses to the esophageal sphincter to stimulate the esophageal sphincter. This at least one electrode bar is also maintained in a fixed position by being trapped by stomach - oesophageal suture thread or by being inserted into the stomach wall. The stimulation pulses may be sent as a series of pulses, and the pulse train is repeated with a time break in between, and this break extends the break between each pulse of the pulse train. The stimulation device may preferably have at least one sensor for sensing the patient's physical parameters or the functional parameters of the movement - restricting device, and an in - body control unit for controlling the stimulation device. This at least one electrode bar is also maintained in a fixed position by being trapped by stomach - oesophageal suture thread or by being inserted into the stomach wall. The stimulation pulses may be sent as a series of pulses, and the pulse train is repeated with a time break in between, and this break extends the break between each pulse of the pulse train. The stimulation device may preferably have at least one sensor for sensing the patient's physical parameters or the functional parameters of the movement - restricting device, and an in - body control unit for controlling the stimulation device. The stimulation device may preferably have at least one sensor for sensing the patient's physical parameters or the functional parameters of the movement - restricting device, and an in - body control unit for controlling the stimulation device. Preferably, it is adapted to incorporate an electronic circuit and an energy source.

[0095] The stimulation device preferably has at least one sensor for sensing the patient's physical parameters or the functional parameters of the movement - restricting device, and an in - body control unit for controlling the stimulation device. The stimulation device preferably has at least one sensor for sensing the patient's physical parameters or the functional parameters of the movement - restricting device, and an in - body control unit for controlling the stimulation device. The in - body control unit usually controls the stimulation device in response to information from the sensor.

[0096] The in - body control unit usually controls the stimulation device in response to information from the sensor.

[0097] For sensing contraction waves in the esophagus or any other parameters related to the ingested food. The sensor sends information to the in-body control unit, and then the in-body control unit stops the stimulation in response to such information from the sensor. to stop the stimulation in response to such information from the sensor.

[0098] The stimulation device can always be controlled by the patient.

[0099] (Stimulation device) Next, the stimulation device of the device will be described.

[0100] The control device is operable by the patient to continuously alternate between an operating mode in which the lower esophageal sphincter is stimulated by an energy pulse and a rest mode in which the lower esophageal sphincter is not stimulated. (The term "patient" includes animals or humans.) Continuously alternating between the operating mode and the rest mode has the advantage that the lower esophageal sphincter can "recover" during the rest mode and as a result be more sensitive in the operating mode. Another advantage is that the energy consumption of this new device can be significantly reduced compared to the conventional continuous stimulation systems discussed above. Further, since the control device is operable by the patient, the patient can select the time to operate the device. For example, for some patients, it may be sufficient to temporarily maintain the device "on" when the patient feels abnormal reflux, such as at night when the patient is lying down, and for other patients, it may be necessary to keep the device "on" all the time except during meal times. ice to continuously alternate between an operating mode in which the lower esophageal sphincter is stimulated by an energy pulse and a rest mode in which the lower esophageal sphincter is not stimulated. ice to continuously alternate between an operating mode in which the lower esophageal sphincter is stimulated by an energy pulse and a rest mode in which the lower esophageal sphincter is not stimulated. (The term "patient" includes animals or humans.) Continuously alternating between the operating mode and the rest mode has the advantage that the lower esophageal sphincter can "recover" during the rest mode and as a result be more sensitive in the operating mode. Another advantage is that the energy consumption of this new device can be significantly reduced compared to the conventional continuous stimulation systems discussed above. Further, since the control device is operable by the patient, the patient can select the time to operate the device. For example, for some patients, it may be sufficient to temporarily maintain the device "on" when the patient feels abnormal reflux, such as at night when the patient is lying down, and for other patients, it may be necessary to keep the device "on" all the time except during meal times. For example, for some patients, it may be sufficient to temporarily maintain the device "on" when the patient feels abnormal reflux, such as at night when the patient is lying down, and for other patients, it may be necessary to keep the device "on" all the time except during meal times. For example, for some patients, it may be sufficient to temporarily maintain the device "on" when the patient feels abnormal reflux, such as at night when the patient is lying down, and for other patients, it may be necessary to keep the device "on" all the time except during meal times. For example, for some patients, it may be sufficient to temporarily maintain the device "on" when the patient feels abnormal reflux, such as at night when the patient is lying down, and for other patients, it may be necessary to keep the device "on" all the time except during meal times. For example, for some patients, it may be sufficient to temporarily maintain the device "on" when the patient feels abnormal reflux, such as at night when the patient is lying down, and for other patients, it may be necessary to keep the device "on" all the time except during meal times. For example, for some patients, it may be sufficient to temporarily maintain the device "on" when the patient feels abnormal reflux, such as at night when the patient is lying down, and for other patients, it may be necessary to keep the device "on" all the time except during meal times.

[0101] According to a preferred embodiment of the present invention, the device has an energy source, and here, when the stimulation device is implanted, the control device is related to the use of power for the stimulation device. to the use of power for the stimulation device. Control the energy source to release energy for this purpose. As a result, the device of the present invention can easily and effectively control the energy supplied to the implanted components of the device, thereby potentially enabling the device to be sustained over the patient's remaining lifespan or at least over a long period of years and ensuring the reliability of its function.

[0102] In a preferred embodiment, the control device is controllable from outside the patient's body to control the stimulation device so as to vary the stimulation intensity of the esophageal sphincter over time. More specifically, the control device is adapted to control the stimulation device to change the stimulation intensity of the esophageal sphincter to vary the tone of the esophageal sphincter. Preferably, the energy source has an energy power supply, and the control device is adapted to control the energy power supply to send electrical pulses to the stimulation device. A implantable switch may be provided for switching the supply of electrical pulses from the energy power supply. This switch may be manually operable by the patient, or alternatively, the control device may have a wireless remote control device that is operable by the patient to control the switch.

[0103] When the stimulation device applies stimulation to the esophageal sphincter using electrical pulses, there is a problem that a voltage intensity of sufficient strength must be achieved to apply the desired electrical stimulation to the esophageal sphincter. This problem is caused by the fact that the strength of the electrical stimulation may weaken over time, which is due to an increase in electrical resistance caused by fibrosis occurring when the conductor engages the esophageal sphincter. This problem is solved by the main embodiment of the present invention. Here, the stimulation ​​​​​​​The device has a conductor that engages the lower esophageal sphincter, and an energy source is adapted to send a current through this conductor, and a control device is adapted to control the energy source to release electrical energy, so that the strength of the current passing through this conductor reaches a predetermined value. Consequently, it is possible to compensate for the decrease in the strength of the current caused by fibrosis that occurs when the conductor is engaged with the lower esophageal sphincter. Therefore, even if the current passing through the conductor weakens, the control device automatically controls the energy source to release more electrical energy to restore the current strength to the desired value. Advantageously, the control device is adapted to control the energy source to release energy in the form of alternating current. The inventors have found that an electrolytic action occurs within the lower esophageal sphincter in the case of direct current rather than alternating current. Such an electrolytic action may damage the lower esophageal sphincter. All of the above embodiments can be combined with at least one implantable sensor for sensing at least one physical parameter of the patient, where the control device can control the stimulation device in response to a signal from the sensor. 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 applying stimulation to the lower esophageal sphincter in response to the sensor sensing the contraction wave of the patient's esophagus. Alternatively, the sensor is a pressure sensor for directly or indirectly sensing the pressure within the esophagus.

[0104]

[0105]

[0106] ​​​​​​​​​​​​​​It may have. The expression "indirectly sense the pressure in the esophagus" should be understood to include cases where the sensor senses the pressure on the stimulator device or the patient's body tissue. It should be.

[0107] The control device may have an in - body control unit implanted into the patient to control the stimulator device, preferably including a micro processor. The in - body control unit can preferably directly control the stimulator device in response to a signal from the sensor. For example, in response to a signal from a sensor of pressure, the patient's position, the contraction wave in the patient's esophagus, or any other important physical parameter whatsoever, the in - body control unit can send information regarding it outside the patient's body. The control unit can also automatically control the stimulator device in response to a signal from the sensor. For example, the control unit can control the stimulator device to efficiently stimulate the lower esophageal sphincter, so that in response to a sensor that senses that the patient is lying on the side, the lower esophageal sphincter is surely and completely closed. Or alternatively, the control device may have an out - of - body control unit outside the patient's body. In this case, the in - body control unit can be programmable by the out - of - body control unit, for example, to control the stimulator device over time. Alternatively, the in - body control unit can control the stimulator device over time according to an operation schedule program that can be adapted to the patient's requirements.

[0108] Or alternatively, the control device may have an out - of - body control unit outside the patient's body. In this case, the in - body control unit can be programmable by the out - of - body control unit, for example, to control the stimulator device over time. Alternatively, the in - body control unit can control the stimulator device over time according to an operation schedule program that can be adapted to the patient's requirements. The in - body control unit can control the stimulator device over time according to an operation schedule program that can be adapted to the patient's requirements.

[0109] Also, the out - of - body control unit can preferably directly control the stimulator device in response to a signal from the sensor. The out - of - body control unit can, based on the physical parameters sensed by the sensor, It can store information about parameters and be manually operated to control a stimulation device based on the stored information. Additionally, there may be at least one implantable transmitter for sending information about physical parameters sensed by a sensor.

[0110] A major advantage is that the patient can use the control device to keep the cardia completely closed by the stimulation device whenever the patient desires during the day. This advantage should not be underestimated. This is because it becomes very difficult for the patient to vomit if the stimulation of the cardia cannot be immediately stopped when the patient needs to vomit.

[0111] Conveniently, the external control unit can load data into the internal control unit according to a loading mode that is only authorized for doctors. When specifically controlling the stimulation device with power, electrical pulse frequency, etc., the external control unit can control the internal control unit according to a doctor mode that is only authorized for doctors. When simply controlling the stimulation device with "on" and "off", etc., the external control unit controls the internal control unit according to a patient mode that is permitted for the patient. Therefore, by using the external control unit according to multiple modes, it becomes possible to allow the patient to control specific functions of the stimulation device and allow doctors to control other more advanced functions, bringing flexibility to the treatment of postoperative patients.

[0112] In the case of the direct usage related to the power of the stimulation device, for example, a series of The energy source may be adapted to control the release of energy intermittently in the form of energy pulses. According to a suitable embodiment of the present invention, a control device controls the energy source to release electrical energy, and the device further has a transplantable capacitor for generating a series of energy pulses from the released energy. In this case, the term "direct" means, on the one hand, that the released energy is used simultaneously when it is released by the control device, and on the other hand, that the released energy may be delayed somewhat in seconds, for example, by an energy stabilizer, before it is used in relation to the power of the stimulation device. It can be adapted to control. According to a suitable embodiment of the present invention, a control device controls the energy source to release electrical energy, and the device further has a transplantable capacitor for generating a series of energy pulses from the released energy. In this case, the term "direct" means, on the one hand, that the released energy is used simultaneously when it is released by the control device, and on the other hand, that the released energy may be delayed somewhat in seconds, for example, by an energy stabilizer, before it is used in relation to the power of the stimulation device. from the released energy. In this case, the term "direct" means, on the one hand, that the released energy is used simultaneously when it is released by the control device, and on the other hand, that the released energy may be delayed somewhat in seconds, for example, by an energy stabilizer, before it is used in relation to the power of the stimulation device. is used simultaneously when it is released by the control device, and on the other hand, that the released energy may be delayed somewhat in seconds, for example, by an energy stabilizer, before it is used in relation to the power of the stimulation device. is used in relation to the power of the stimulation device. before it is used in relation to the power of the stimulation device.

[0113] Hereinafter, further embodiments related to the supply and control of energy will be described. All of these embodiments can be used not only for the stimulation device but also for all other applicable embodiments in this specification. All of these embodiments can be used not only for the stimulation device but also for all other applicable embodiments in this specification. applicable embodiments.

[0114] According to an embodiment of the present invention, the device has a transplantable electrical component including at least one or a single voltage level guard, and a capacitor or an accumulator, where the charging and discharging of the capacitor or the accumulator are controlled by using the voltage level guard. including at least one or a single voltage level guard, and a capacitor or an accumulator, where the charging and discharging of the capacitor or the accumulator are controlled by using the voltage level guard. In one embodiment, the energy source is outside the patient's body, and the control device controls the energy source to release wireless energy. The energy storage device, preferably an electrical accumulator, stores the wireless energy released from the external energy source outside the body. by using the voltage level guard.

[0115] In one embodiment, the energy source is outside the patient's body, and the control device controls the energy source to release wireless energy. The energy storage device, preferably an electrical accumulator, stores the wireless energy released from the external energy source outside the body. to release wireless energy. The energy storage device, preferably an electrical accumulator, stores the wireless energy released from the external energy source outside the body. from the external energy source outside the body. The device may be implanted in the patient to store wireless energy. The power supply consists of at least one capacitor or at least one rechargeable battery, or The combination may include at least one capacitor and at least one rechargeable battery. Alternatively, in addition to wireless energy delivery, electrical energy can be delivered to the implanted device. A battery may be implanted within the patient to supply the electrical energy consuming elements that are being used. If the control device has an implantable control unit, the electronic circuitry and the stimulation device , by converted wireless energy or by implanted energy storage devices. The device may be powered directly by energy from either a gas or a battery.

[0116] In one embodiment, the wireless energy is used directly to power a stimulation device. That is, the stimulation device is a device that transmits wireless energy to an external device via a control device. It is powered when it is released from an energy source. In this case, the word "directly" is used. The term, on the other hand, refers to the fact that the stimulation device uses the released energy without storing it. This means that the energy released is instantly powered by the stimulus data. for example by an energy stabilizer within seconds before being used to power the vice. In either case, wireless energy The wireless field acts directly on the device or When wireless energy is transmitted or indirectly after the accumulator is charged Use wireless energy to power any energy consuming part of the device By using an energy conversion device for converting into electrical energy that can be obtained, it can be used to generate direct kinetic energy. As a result, the stimulation device can be controlled very easily all the time, and only a few components to be implanted in the device are required. For example, there is no implanted energy source such as a battery, and there is also no implanted complex signal control system. This brings the advantage that the

[0117] reliability of the device becomes very high. In one embodiment, the energy source includes an implantable energy internal supply source. In that case, when the energy internal supply source is implanted in the patient, the control device controls the energy internal supply source to release energy from outside the patient's body. This solution is advantageous for sophisticated embodiments of devices with relatively high energy consumption that cannot be satisfied only by direct supply of wireless energy. The energy internal supply source preferably includes an energy power source such as an accumulator or a battery. Alternatively, the control device may be adapted to release wireless energy from the energy internal supply source, and further may be adapted to control the stimulation device to apply stimulation to the patient's esophageal sphincter using the released

[0118] wireless energy. The wireless energy may include radiant energy or acoustic energy such as ultrasonic energy. and has an in - body energy power source, such as a battery, implanted in the patient for supplying energy Here, the switch directly or indirectly affects the supply of electrical energy from the in - body energy power source. This solution is advantageous for embodiments of devices with a relatively large energy consumption that cannot be satisfied by only the direct supply of wireless energy .

[0119] In one embodiment of the present invention, the switch switches between an "off" mode in which the in - body energy power source is not used and an " on" mode in which the in - body energy power source supplies electrical energy for the power of the stimulation device. In this case, this switch is conveniently operated by wireless energy released from an external energy supply source to switch between the "on" mode and the "off" mode. Preferably, a control device having a wireless remote control device can control the external energy supply source to release wireless energy . The advantage of this embodiment is that when the switch is in the off - mode, the implanted energy supply source does not supply energy, so that the life of the implanted energy power source, such as a battery, can be significantly extended . .

[0120] In one embodiment, the control device has a wireless remote control device for controlling the in - body energy power source. In this case, the switch switches between an "off" mode in which the in - body energy power source and the remote control device are not used and a "standby" mode in which the remote control device can control the in - body energy power source to supply electrical energy for the power of the stimulation device, by wireless energy from an external energy supply source ​​​​​​​​is operable.

[0121] In one embodiment, the device further includes an energy conversion device implanted in a patient for converting wireless energy into storable energy, and a transplantable energy storage device for storing the storable energy. Here, the switch is operable by energy from the implanted energy storage device to switch between an "off" mode in which the in-body power source of energy is not used and an "on" mode in which the in-body power source of energy supplies electrical energy for powering the stimulation device. In this case, the control device preferably has a wireless remote control device for controlling the energy storage device to operate the switch. In one embodiment, the device further includes an energy conversion device implanted in a patient for converting wireless energy into storable energy, and a transplantable energy storage device for storing the storable energy. Here, the switch is operable by energy from the implanted energy storage device to switch between an "off" mode in which the in-body power source of energy is not used and an "on" mode in which the in-body power source of energy supplies electrical energy for powering the stimulation device. In this case, the control device preferably has a wireless remote control device for controlling the energy storage device to operate the switch. In one embodiment, the device further includes an energy conversion device implanted in a patient for converting wireless energy into storable energy, and a transplantable energy storage device for storing the storable energy. Here, the switch is operable by energy from the implanted energy storage device to switch between an "off" mode in which the in-body power source of energy is not used and an "on" mode in which the in-body power source of energy supplies electrical energy for powering the stimulation device. In this case, the control device preferably has a wireless remote control device for controlling the energy storage device to operate the switch. In one embodiment, the device further includes an energy conversion device implanted in a patient for converting wireless energy into storable energy, and a transplantable energy storage device for storing the storable energy. Here, the switch is operable by energy from the implanted energy storage device to switch between an "off" mode in which the in-body power source of energy is not used and an "on" mode in which the in-body power source of energy supplies electrical energy for powering the stimulation device. In this case, the control device preferably has a wireless remote control device for controlling the energy storage device to operate the switch. In one embodiment, the device further includes an energy conversion device implanted in a patient for converting wireless energy into storable energy, and a transplantable energy storage device for storing the storable energy. Here, the switch is operable by energy from the implanted energy storage device to switch between an "off" mode in which the in-body power source of energy is not used and an "on" mode in which the in-body power source of energy supplies electrical energy for powering the stimulation device. In this case, the control device preferably has a wireless remote control device for controlling the energy storage device to operate the switch. In one embodiment, the device further includes an energy conversion device implanted in a patient for converting wireless energy into storable energy, and a transplantable energy storage device for storing the storable energy. Here, the switch is operable by energy from the implanted energy storage device to switch between an "off" mode in which the in-body power source of energy is not used and an "on" mode in which the in-body power source of energy supplies electrical energy for powering the stimulation device. In this case, the control device preferably has a wireless remote control device for controlling the energy storage device to operate the switch. In one embodiment, the device further includes an energy conversion device implanted in a patient for converting wireless energy into storable energy, and a transplantable energy storage device for storing the storable energy. Here, the switch is operable by energy from the implanted energy storage device to switch between an "off" mode in which the in-body power source of energy is not used and an "on" mode in which the in-body power source of energy supplies electrical energy for powering the stimulation device. In this case, the control device preferably has a wireless remote control device for controlling the energy storage device to operate the switch. In one embodiment, the device further includes an energy conversion device implanted in a patient for converting wireless energy into storable energy, and a transplantable energy storage device for storing the storable energy. Here, the switch is operable by energy from the implanted energy storage device to switch between an "off" mode in which the in-body power source of energy is not used and an "on" mode in which the in-body power source of energy supplies electrical energy for powering the stimulation device. In this case, the control device preferably has a wireless remote control device for controlling the energy storage device to operate the switch.

[0122] An external data communicator may be provided outside the patient's body, and an in-body data communicator implanted in the patient may be provided for communicating with the external data communicator. The in-body data communicator can send back data related to the patient or related to the stimulation device to the external data communicator. Alternatively or in combination, the external data communicator can send data to the in-body data communicator. The in-body data communicator can preferably send data related to at least one physical signal of the patient. An external data communicator may be provided outside the patient's body, and an in-body data communicator implanted in the patient may be provided for communicating with the external data communicator. The in-body data communicator can send back data related to the patient or related to the stimulation device to the external data communicator. Alternatively or in combination, the external data communicator can send data to the in-body data communicator. The in-body data communicator can preferably send data related to at least one physical signal of the patient. An external data communicator may be provided outside the patient's body, and an in-body data communicator implanted in the patient may be provided for communicating with the external data communicator. The in-body data communicator can send back data related to the patient or related to the stimulation device to the external data communicator. Alternatively or in combination, the external data communicator can send data to the in-body data communicator. The in-body data communicator can preferably send data related to at least one physical signal of the patient. An external data communicator may be provided outside the patient's body, and an in-body data communicator implanted in the patient may be provided for communicating with the external data communicator. The in-body data communicator can send back data related to the patient or related to the stimulation device to the external data communicator. Alternatively or in combination, the external data communicator can send data to the in-body data communicator. The in-body data communicator can preferably send data related to at least one physical signal of the patient. An external data communicator may be provided outside the patient's body, and an in-body data communicator implanted in the patient may be provided for communicating with the external data communicator. The in-body data communicator can send back data related to the patient or related to the stimulation device to the external data communicator. Alternatively or in combination, the external data communicator can send data to the in-body data communicator. The in-body data communicator can preferably send data related to at least one physical signal of the patient. An external data communicator may be provided outside the patient's body, and an in-body data communicator implanted in the patient may be provided for communicating with the external data communicator. The in-body data communicator can send back data related to the patient or related to the stimulation device to the external data communicator. Alternatively or in combination, the external data communicator can send data to the in-body data communicator. The in-body data communicator can preferably send data related to at least one physical signal of the patient.

[0123] Preferably, a transplantable stabilizer such as a capacitor or a rechargeable accumulator may be provided to stabilize the electrical energy released by the control device. Also, the control device can control the energy source to release energy for a predetermined time or for a predetermined number of energy pulses. Preferably, a transplantable stabilizer such as a capacitor or a rechargeable accumulator may be provided to stabilize the electrical energy released by the control device. Also, the control device can control the energy source to release energy for a predetermined time or for a predetermined number of energy pulses. Preferably, a transplantable stabilizer such as a capacitor or a rechargeable accumulator may be provided to stabilize the electrical energy released by the control device. Also, the control device can control the energy source to release energy for a predetermined time or for a predetermined number of energy pulses. Preferably, a transplantable stabilizer such as a capacitor or a rechargeable accumulator may be provided to stabilize the electrical energy released by the control device. Also, the control device can control the energy source to release energy for a predetermined time or for a predetermined number of energy pulses.

[0124] All of the above embodiments are preferably remotely controlled. Thus, the control device advantageously has a wireless remote control device for transmitting at least one wireless control signal for controlling the stimulation device. By using this remote control device, it becomes possible to routinely adapt the function of the device to the patient's requirements, which is beneficial for the patient's treatment. The wireless remote control device may be able to obtain information regarding the state of the stimulation device and may be able to control the stimulation device in response to that information. Further, this remote control device may be able to send information related to the stimulation device from inside the patient's body to the outside.

[0125]

[0126] In a particular embodiment of the present invention, the wireless remote control device has at least one extracorporeal signal transmitter or transceiver and at least one intracorporeal signal receiver or transceiver that can be implanted in the patient. In another particular embodiment of the present invention, the wireless remote control device has at least one extracorporeal signal receiver or transceiver and at least one intracorporeal signal transmitter or transceiver that can be implanted in the patient.

[0127] The remote control device can transmit a carrier wave signal to carry the control signal, where the carrier wave signal is a frequency, amplitude, or a modulated frequency and amplitude, and is digital, analog, or digital and analog. Also, the control signal used with the carrier wave signal may be a frequency, amplitude, or a modulated frequency and amplitude.

[0128] ​​​​​​​​​​​​​​The control signal may include wave signals such as acoustic signals, such as ultrasonic signals, infrared signals, visible light signals, ultraviolet ray signals, laser signals, microwave signals, radio signals, X-ray radiation signals or gamma radiation signals, etc., any electromagnetic wave signal such as that. When applicable, two or more of the above signals may be combined.

[0129] The control signal may be digital or analog and may have an electric field or a magnetic field. Preferably, the wireless remote control device can transmit an electromagnetic carrier wave signal for carrying a digital or analog control signal. For example, safe communication is achieved by using an analog carrier wave signal that carries a digital control signal. The control signal can be transmitted in the form of pulses by the wireless remote control device.

[0130] The control device can be operated manually or non-manually to control the energy source so as to release energy.

[0131] In the embodiments of the present invention shown above, the released energy may include electrical energy, and a transplantable capacitor having a capacitance of less than 0.1 μF may be provided to generate the above series of energy pulses.

[0132] Generally, wireless energy includes signals.

[0133] The device may further include a transplantable energy conversion device for directly or indirectly converting wireless energy in the form of, for example, sound waves into electrical energy for the power of the stimulation device. More specifically, this energy conversion device performs the conversion ​​​​​​​​​​having a capacitor adapted to generate electrical pulses from the supplied electrical energy It is possible.

[0134] Generally, the stimulation device is advantageously embedded in a soft material or a gel-like material such as silicon having a hardness of less than 20 Shore material.

[0135] The stimulation device may include a band applied around the sphincter, the band having a conductor that contacts the sphincter muscle. The conductor can have a hook for fixing the conductor to the sphincter. The present invention also provides a transplantable stimulation device adapted to stimulate the patient's sphincter to strengthen the tone of the sphincter, and a control device for controlling the stimulation device so as to continuously alternate between an operating mode in which the sphincter is stimulated by an energy pulse and a rest mode in which the sphincter is not stimulated. To provide a system for treating heartburn and reflux disease. The energy pulse may include an electrical pulse. The stimulation device may have a conductor engaged with the sphincter, and the energy source may be adapted to pass an electric current through the conductor to generate an electric pulse. Advantageously, the control device can control the energy source to release electrical energy so that the current passing through the conductor reaches a predetermined value. muscle. to have. muscle, and an energy - Pulse-stimulated operating mode and rest in which the sphincter is not stimulated mode and a control device for controlling the stimulation device to continuously alternate between the two. to provide a system for treating heartburn and reflux disease. The energy pulse may include an electrical pulse. The stimulation device may have a conductor engaged with the sphincter, and the energy source may be adapted to pass an electric current through the conductor to generate an electric pulse. Advantageously, the control device can control the energy source to release electrical energy so that the current passing through the conductor reaches a predetermined value. and the energy source may be adapted to pass an electric current through the conductor to generate an electric pulse. Advantageously, the control device can control the energy source to release electrical energy so that the current passing through the conductor reaches a predetermined value. to do.

[0136] All of the various components described above can be combined into another embodiment if applicable. Also, the various functions described in connection with the above-described embodiments of the present invention can be used for other applications if applicable. In addition, the various functions described in connection with the above-described embodiments of the present invention can be used for other applications if applicable. If applicable, it can also be used for other purposes.

[0137] For transmitting energy and for controlling energy as presented in this specification All of the various techniques can be implemented using all of the various components and solutions described thereof.

[0138] The present invention also provides a method for treating heartburn and reflux disease.

[0139] Accordingly, according to a first alternative method implanting a stimulation device into a patient to engage the stimulation device with the cardia and and energizing the cardiac sphincter with energy pulses to strengthen the tone of the sphincter and fully close the cardia, and controlling the stimulation device to continuously alternate between an operating mode in which the cardiac sphincter is stimulated with energy pulses and a rest mode in which the cardiac sphincter is not stimulated is provided a method for treating heartburn and reflux disease.

[0140] The first alternative method can also be performed laparoscopically. Accordingly implanting a stimulation device into a patient using a laparoscope to engage the stimulation device with the cardia and and energizing the cardiac sphincter with energy pulses to strengthen the tone of the sphincter and fully close the cardia, and controlling the stimulation device to continuously alternate between an operating mode in which the cardiac sphincter is stimulated with energy pulses and a rest mode in which the cardiac sphincter is not stimulated is provided a laparoscopic method for treating heartburn and reflux disease. (laparoscopic method) can be provided.

[0141] According to a second alternative method (a) surgically implanting an electrical stimulation device engaged with the cardia into a patient and ​(b) providing an energy source outside the patient's body; (c) controlling an external energy source from outside the patient's body to release wireless energy; and (d) using the released wireless energy in relation to powering a stimulation device. A method for treating patients suffering from heartburn and reflux disease is provided.

[0142] A second alternative method may further include implanting an energy conversion device, controlling an external energy source from outside the patient's body to release wireless energy, and converting, by the energy conversion device, the wireless energy into an energy different from the wireless energy for use in relation to powering a stimulation device. This method may further include implanting a stabilizer into the patient to stabilize the energy converted by the energy conversion device.

[0143] Furthermore, implanting a stimulation device into the patient to engage the lower esophageal sphincter, providing a control device for controlling the stimulation device to apply stimulation to the lower esophageal sphincter to strengthen the tone of the sphincter so that the lower esophageal sphincter closes completely, and enabling the patient to operate the control device to vary the intensity of the stimulation. A method for treating heartburn and reflux disease is provided.

[0144] In one embodiment, an energy pulse creates stimulation to the lower esophageal sphincter to strengthen the tone of the sphincter so that the lower esophageal sphincter closes completely, and the control device is provided to the patient. ​ There is provided an apparatus that is operable and thus can be set to stop, wherein the control device is further operable by a patient to set the stimulation device to an operating state, and in this operating state, the stimulation device continuously alternates between an operating mode in which the esophageal sphincter is stimulated by the above energy pulses and a rest mode in which the esophageal sphincter is not stimulated, and here, the apparatus further has at least one implantable sensor for sensing at least one physical parameter of the patient, wherein the control device is adapted to control the stimulation device to stop the continuous alternation between the operating mode and the rest mode and is further adapted to set the stimulation device to the rest mode in response to the sensor sensing the physical parameter of the patient. In one embodiment, there is provided an apparatus that creates stimulation of the esophageal sphincter by energy pulses to strengthen the tone of the sphincter so that the esophagus is completely closed, and the above control device is operable by a patient and thus can be set to stop, wherein the control device is further operable by a patient to set the stimulation device to an operating state, and in this operating state, the stimulation device continuously alternates between an operating mode in which the esophageal sphincter is stimulated by the above energy pulses and a rest mode in which the esophageal sphincter is not stimulated, and here, the apparatus further has at least one implantable sensor for sensing at least one contraction wave of the esophagus caused by the patient swallowing food as a physical parameter of the patient,

[0145] wherein the control device is adapted to control the stimulation device to stop the continuous alternation between the operating mode and the rest mode and is further adapted to set the stimulation device to the rest mode in response to the sensor sensing the physical parameter of the patient. and here, the control device is adapted to control the stimulation device to stop the continuous alternation between the operating mode and the rest mode and is further adapted to set the stimulation device to the rest mode in response to the sensor sensing the physical parameter of the patient. and here, the apparatus further has at least one implantable sensor for sensing at least one contraction wave of the esophagus caused by the patient swallowing food as a physical parameter of the patient, wherein the control device is adapted to control the stimulation device to stop the continuous alternation between the operating mode and the rest mode and is further adapted to set the stimulation device to the rest mode in response to the sensor sensing the physical parameter of the patient. and in this operating state, the stimulation device continuously alternates between an operating mode in which the esophageal sphincter is stimulated by the above energy pulses and a rest mode in which the esophageal sphincter is not stimulated, Control the stimulation device to stop continuous alternation between the active mode and the rest mode Adapted to respond to a sensor that further senses the contraction wave of the patient's esophagus and further control the stimulation device Is adapted to be set to the rest mode.

[0146] (Surface structure) Next, the surface structures of various implants of the present invention will be described.

[0147] The present invention relates to an implant adapted to be adjustable after surgery and having at least one expandable section This implant is adapted to be adjustable between a first folded state and a second expanded state. In the first folded state, the expandable section is folded And in the second expanded state, the expandable section is expanded. 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 above expandable section At least partially includes a surface structure having high regions alternating with low regions. The expandable section In at least one of the above first folded state and the second expanded state, due to the growth of fibrous tissue, adjacent high regions To prevent the adjustability between the first folded state and the second expanded state of the above implant from being impaired To such an extent that they are directly interconnected, it is adapted to have a first distance between adjacent high regions that is fully expanded The expandable section having a connection region between adjacent high regions and low regions In at least one of the above first folded state and the second expanded state, due to the growth of fibrous tissue, adjacent connection regions To prevent the adjustability between the first folded state and the second expanded state of the above implant from being impaired To such an extent that they are directly interconnected, it is adapted to have a second distance between adjacent connection regions that is fully expanded The expandable section having a connection region between adjacent high regions and low regions To prevent the adjustability between the first folded state and the second expanded state of the above implant from being impaired is further adapted to have a gap.

[0148] According to one embodiment, the expandable section is hollow or includes a hollow body.

[0149] According to another embodiment, the implant is substantially completely hollow or has a hollow body that extends substantially along the entire length and / or entire volume of the implant. The fibrous tissue often has an extension amount or thickness of about 0.5 mm to about 1.5 mm.

[0150] Thus, the distance between the corresponding surfaces of the elements of the surface structure is preferably about 3 mm, that is, approximately 2 × 1.5 mm or more. However, depending on the surroundings, a distance of about 1.0 mm to more than about 3 mm may be sufficient. When the fibrous tissue is expected to have an extension amount or thickness exceeding about 1.5 mm, the distance between the corresponding surfaces of the elements of the surface structure is appropriately adapted.

[0151] The surface structure may have high regions and low regions, and the distance between the different planes of the high regions and the low regions may also be greater than a specific threshold to assist the function of folding or expanding the implant. If the above distance is too small, the function of folding or expanding the implant may be restricted. The appropriate interval of the above distance is about 0.5 mm to 10 mm, more preferably about 2 mm to 8 mm, and 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 satisfied. The surface structure can include, for example, protrusions and grooves of different shapes. ​​​​​​​​​​​The draw grooves each can have, for example, a cross-section in the shape of a wedge, polygon, square, pyramid or truncated pyramid. Furthermore, the raised portions and grooves may have different cross-sectional shapes. The surface structure generally may have a bellows-shaped configuration or a surface structure such that geometric objects of the same or different types (plural possible) are arranged on the surface. The geometric objects may be arranged on the surface substantially randomly or according to a certain pattern. Among the types of implants that may be considered suitable are implants having the ability to substantially change shape and / or size. Thus, this applies when there is a possibility that the function of the implant is substantially obstructed or inhibited by the presence of fibrous tissue. However, this surface structure can be used for any implant if the characteristics of the surface structure are advantageous for the implant.

[0152] These various embodiments can be combined with various treatment methods for obesity. In particular, two embodiments will be described below, one including an expansion device and the other including a volume filling device. (Combination with obesity treatment) It should be noted that for all different embodiments herein, the entire embodiment or part of the embodiment or method can be used when applicable. Also, various embodiments of the device for treating reflux can be combined with a device for treating obesity based on the fact that it can create a feeling of fullness by creating an action of expanding the gastric wall. One side of the gastric wall (For an expansion device for obesity treatment)

[0153] These various embodiments can be combined with various treatment methods for obesity. In particular, two embodiments will be described below, one including an expansion device and the other including a volume filling device. It should be noted that for all different embodiments herein, the entire embodiment or part of the embodiment or method can be used when applicable. Also, various embodiments of the device for treating reflux can be combined with a device for treating obesity based on the fact that it can create a feeling of fullness by creating an action of expanding the gastric wall. One side of the gastric wall

[0154] When applicable, it should be noted that for all different embodiments herein, the entire embodiment or part of the embodiment or method can be used. Also, various embodiments of the device for treating reflux can be combined with a device for treating obesity based on the fact that it can create a feeling of fullness by creating an action of expanding the gastric wall. One side of the gastric wall (For an expansion device for obesity treatment) Based on the fact that various embodiments of the device for treating reflux can create a feeling of fullness by creating an action of expanding the gastric wall, they can be combined with a device for treating obesity. One ​​By providing a device with an expansion device for expanding the part, a device that is simpler, safer, and acts for a longer period of time can be obtained.

[0155] The expression "power supply" should be understood to mean anything other than manual power, preferably energized by electrical energy. In other words, the adjustment device is operated non - manually. The expression "non - manually" means that the adjustment device is not operated by manually contacting a component implanted subcutaneously in the device, nor is it operated by further contacting the patient's skin. Thus, unlike the conventional techniques when treating anal incontinence, the adjustment device of the present invention is not operated by manual power such as manually compressing a fluid - containing balloon implanted in the scrotum or in the region of the labia majora. Of course, in addition to manually operating a start - button subcutaneously to activate a powered operation device, manually operating an implanted reservoir or using another mechanical or hydraulic solution may also be used and anything within the scope of the present invention is possible.

[0156] Alternatively or preferably, in combination with a powered operation device, servo means such as a gear - box may be used to reduce speed and increase force or torque, for example to rotate a motor at high speed with a weak force. The servo means may include hydraulic means, electrical control means, magnetic means or mechanical means that can be operated by manual operating means and / or a remote control device. By using a servo - system, the The use of force can be reduced when adjusting, which is important in many applications. There is a possibility.

[0157] The term "servo means" includes the normal definition of a servo mechanism, i.e., an automatic device that controls a large amount of power with a very small amount of power but, as an alternative or additionally, it may also include the definition of a force multiplier mechanism that transmits a weak force acting on a long-stroke operating element as a strong force acting on another operating element with a short stroke. The servo means may include a motor, preferably an electric motor which is reversible.

[0158] As an alternative or preferably in combination with manual operation, for example, a patient's strong hand operates, for example, a hydraulic reservoir to move a small amount of fluid with a strong force to control a large movement of the fluid, reversed servo means such as can be used. The reversed servo means may include hydraulic means, electric control means, magnetic means or mechanical means that can be actuated by manual operation means and / or by remote control . By using a reversed servo system, the use of stroke can be reduced when adjusting the adjustment device, which may be important in many applications. There is a possibility that this is important in many applications.

[0159] The term "reversed servo means" includes the definition of a device controlled by a strong force and a slight stroke, i.e., for example, moving a small amount of fluid with a large force to control the movement of a large amount of fluid with a very weak force but, as an alternative or additionally, transmitting a strong force acting on a short-stroke operating element as a strong force acting on another operating element with a long stroke. It may also include the definition of a reverse multiplier mechanism that transmits as a weak force. The reverse servo means is preferably used when manual device control through intact skin is possible.

[0160] Generally, two positions on the stomach wall must be relatively moved away from each other, whereby a small portion of the stomach wall can be expanded to give a feeling of fullness. This can be achieved in many different ways. One way is to expand an implant device that is implanted into the stomach wall Another way is to move two fixed positions on the stomach wall. Of course the first and second positions can be sutured or fixed to the stomach wall in many conceivable ways, and the present invention includes all possibilities of moving two portions of the stomach wall away from each other, thereby moving the first fixed position of the device relative to the second fixed position at at least two positions on the stomach wall to expand the stomach wall. However, it is preferred that at least one fitted portion of the device is implanted to be gently and pendulously connected to the stomach wall, where long-term stable positioning is facilitated by fibrotic stomach to stomach tissue.

[0161] 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 expanding a portion of the stomach wall by moving at least two portions of the stomach wall away from each other any motor, any pump, or any movable material that changes shape when powered may be used.

[0162] Any kind of hydraulic operation may be employed. It should be understood 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 expander device. Preferably, the reservoir has a fixed position for maintaining the reservoir in a desired position when the patient operates it . When compressed, the reservoir preferably maintains the compressed state and is released by being pressed again .

[0163] Any kind of hydraulic solution may be used for the expander device. The hydraulic solution may be mechanically or manually driven by being powered by any motor or pump .

[0164] Of course, simply expanding the sunken part of the stomach also causes the stomach wall to expand in a direction away from it , which may also be achieved mechanically, hydraulically, pneumatically, or by being powered by a motor or pump , or manually

[0165] (Volume filling device for treating obesity) Furthermore, various embodiments of the device for treating reflux are additionally adaptable to treat obesity based on the ability of the distal portion of the elongated movement restricting device in the stomach to fill a volume . In this context, when considering the volume filling device and its characteristics , functions and adaptability, reference is made to the distal portion of the elongated movement restricting device . Any feature, embodiment, embodiment or part of the method described here may be used for both the distal and proximal portions of the movement restricting device where applicable . ​​ Please note that

[0166] The following embodiments are based on the fact that by inserting a volume filling device (herein shown as the distal portion of the movement restricting device) into the patient's gastric wall, this inflatable object can be protected from gastric acid and therefore can maintain its function over a very long period of time.

[0167] According to one embodiment of the present invention, there is provided an apparatus for treating obesity and reflux in a patient having a stomach with a food cavity, the apparatus comprising at least one volume filling device adapted to be at least substantially inserted into a portion of the patient's gastric wall, wherein the volume filling device is adapted to be disposed outside the gastric wall, whereby the volume of the food cavity is reduced by a volume substantially exceeding the volume of the volume filling device, wherein the surface of the volume filling device comprises a biocompatible material, wherein a substantial portion of the surface of the volume filling device is adapted to face and rest outside the gastric wall, and wherein the volume filling device has a maximum perimeter of at least 30 mm.

[0168] Outside the gastric wall, by inserting the volume filling device into a portion of the patient's gastric wall, the volume filling device is protected from gastric acid, thereby obtaining a device that can last for a long time.

[0169] The volume filling device is adapted to be disposed such that its outer surface faces and rests against the gastric wall, whereby the volume size of the food cavity is reduced by a volume substantially exceeding the volume of the volume filling device. The volume filling device has a maximum perimeter of at least 30 millimeters.​​​​​​​​​ It has a large circumference. Therefore, the device of the present invention, in addition to the reflux disease of obese patients, is very suitable for treating the obesity of that patient. Reflux disease is very common among people suffering from obesity, so this is advantageous.

[0170] According to the first option, the volume filling device is adapted to be placed inside the stomach in a state where the outer surface of the volume filling device faces the inside of the stomach wall and is stationary.

[0171] According to the second option, the volume filling device is adapted to be placed outside the stomach in a state where the outer surface of the volume filling device faces the outside of the stomach wall and is stationary.

[0172] Preferably, the volume filling device is adapted to be completely indented by the patient's stomach wall and to be placed inside or outside the stomach wall via a gastroscope examination instrument. For this purpose, the volume filling device may have a mounting device adapted to cooperate with a grasping instrument. Preferably, the volume filling device is adapted to be non-invasively adjusted after surgery.

[0173] The device may have one fixing device, preferably two or more fixing devices, adapted to be involved in fixing the volume filling device to the stomach wall. The volume filling device may have one holding device, preferably two or more holding devices, adapted to be held by an instrument to simplify the implantation of the device.

[0174] At least a part of the volume filling device may be made of a material that is not decomposed by gastric acid. The volume filling device may be decomposable by an acid such as hydrochloric acid. ​

[0175] In one embodiment, the volume filling device is expandable to an expanded state and defines a chamber. The volume filling device has an enclosure wall that is filled with a gel or fluid that is dispensed into the chamber. At least one tube is expanded to supply gel or fluid to the chamber. It may be connected to a filling device. An injection port may be provided which is connectable to tubing. and a volume filling member having an inlet port for fluid or gel that is connectable to a gastroscopy instrument. may be provided, where the inlet port interfaces with the inflatable device and the gastroscopy instrument. The fluid connections are adapted to interconnect the fluid connectors.

[0176] The volumetric filling device contains a homogenous material, such as a gel, having a Shure value of less than 15. The device may also be a solid body.

[0177] The volume filling device may have a rigid, elastic or flexible outer surface. If is rigid, the outer surface will not deform under the forces generated by stomach movement. The volumetric filling device is made of a flexible, inelastic material and has a high degree of rigidity to maintain the shape of the volumetric filling device. It may contain.

[0178] According to a first schematic design of the volume filling device, the device has an axis passing through the device. The maximum circumference is seen in a plane perpendicular to the axis. As seen, the perimeter of the device is equal to the maximum perimeter or starts from the maximum perimeter along the above axis. For example, the device may be substantially oval, spherical, or , or may be substantially oval or curved oval with a concave central section.

[0179] According to a second schematic design of the device, the perimeter of the device as seen in a plane perpendicular to the axis passing through the device increases and decreases at least twice as the plane is displaced along the axis, or increases at least once with a slight decrease as the plane is displaced along the axis. For example, the device may be substantially kidney-shaped.

[0180] The volume filling device has an elongated shape, a circular shape, a bent shape and / or a curved shape.

[0181] The volume filling device has a perimeter of at least 120 mm, 150 mm, 180 mm or 220 mm .

[0182] The volume filling device has a volume in the range from 0.0001 m 3 to 0.001 m 3 , or from 0.00001 m 3 to 0.001 m 3 , or from 0.00001 m 3 to 0.0002 m 3 . The volume of the volume filling device is less than 0.0002 m . 3

[0183] The volume filling device may have at least two interconnectable parts adapted to be placed inside or outside the stomach as separate parts.

[0184] The volume filling device may contain an elastic material, a biocompatible material and / or silicon.

[0185] Preferably, the volume filling device has a coating. For example, there is a parylene coating, a polytetrafluoroethylene coating or a polyurethane coating. ​​​​​​ These coatings may be multi-layer coatings. The volume filling device may have an outer surface layer of polyurethane, Teflon® (PTFE), or a combination thereof. These coatings may be multi-layer coatings. The volume filling device may have an outer surface layer of polyurethane, Teflon® (PTFE), or a combination thereof. These coatings may be multi-layer coatings. The volume filling device may have an outer surface layer of polyurethane, Teflon® (PTFE), or a combination thereof.

[0186] The volume filling device may contain a fluid adapted to transform into a solid phase, i.e., a fixed form. This fluid may be liquid polyurethane, i.e., isosmotic. This fluid may contain macromolecules such as iodine molecules to prevent diffusion. The volume filling device may contain a fluid adapted to transform into a solid phase, i.e., a fixed form. This fluid may be liquid polyurethane, i.e., isosmotic. This fluid may contain macromolecules such as iodine molecules to prevent diffusion. The volume filling device may contain a fluid adapted to transform into a solid phase, i.e., a fixed form. This fluid may be liquid polyurethane, i.e., isosmotic. This fluid may contain macromolecules such as iodine molecules to prevent diffusion.

[0187] 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 its maximum diameter, thereby allowing it to be inserted into a laparoscopic trocar. 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 its maximum diameter, thereby allowing it to be inserted into a laparoscopic trocar. 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 its maximum diameter, thereby allowing it to be inserted into a laparoscopic trocar.

[0188] Preferably, the volume filling device is adapted to be maintained in a fixed position by a gastro-gastric suture or staple for inserting the device into the gastric wall. Advantageously, the volume filling device has a perimeter that changes to be better maintained in a fixed position when it is inserted into the patient's gastric wall. The gastro-gastric suture or staple may be provided with a fixing portion adapted to form a structure that contacts the gastric wall to promote the internal growth of human tissue and fix the position of the volume filling device attached to the gastric wall for a long time. This structure may include a net-like structure. Preferably, the volume filling device is adapted to be maintained in a fixed position by a gastro-gastric suture or staple for inserting the device into the gastric wall. Advantageously, the volume filling device has a perimeter that changes to be better maintained in a fixed position when it is inserted into the patient's gastric wall. The gastro-gastric suture or staple may be provided with a fixing portion adapted to form a structure that contacts the gastric wall to promote the internal growth of human tissue and fix the position of the volume filling device attached to the gastric wall for a long time. This structure may include a net-like structure. Preferably, the volume filling device is adapted to be maintained in a fixed position by a gastro-gastric suture or staple for inserting the device into the gastric wall. Advantageously, the volume filling device has a perimeter that changes to be better maintained in a fixed position when it is inserted into the patient's gastric wall. The gastro-gastric suture or staple may be provided with a fixing portion adapted to form a structure that contacts the gastric wall to promote the internal growth of human tissue and fix the position of the volume filling device attached to the gastric wall for a long time. This structure may include a net-like structure. Preferably, the volume filling device is adapted to be maintained in a fixed position by a gastro-gastric suture or staple for inserting the device into the gastric wall. Advantageously, the volume filling device has a perimeter that changes to be better maintained in a fixed position when it is inserted into the patient's gastric wall. The gastro-gastric suture or staple may be provided with a fixing portion adapted to form a structure that contacts the gastric wall to promote the internal growth of human tissue and fix the position of the volume filling device attached to the gastric wall for a long time. This structure may include a net-like structure. Preferably, the volume filling device is adapted to be maintained in a fixed position by a gastro-gastric suture or staple for inserting the device into the gastric wall. Advantageously, the volume filling device has a perimeter that changes to be better maintained in a fixed position when it is inserted into the patient's gastric wall. The gastro-gastric suture or staple may be provided with a fixing portion adapted to form a structure that contacts the gastric wall to promote the internal growth of human tissue and fix the position of the volume filling device attached to the gastric wall for a long time. This structure may include a net-like structure. Preferably, the volume filling device is adapted to be maintained in a fixed position by a gastro-gastric suture or staple for inserting the device into the gastric wall. Advantageously, the volume filling device has a perimeter that changes to be better maintained in a fixed position when it is inserted into the patient's gastric wall. The gastro-gastric suture or staple may be provided with a fixing portion adapted to form a structure that contacts the gastric wall to promote the internal growth of human tissue and fix the position of the volume filling device attached to the gastric wall for a long time. This structure may include a net-like structure. Preferably, the volume filling device is adapted to be maintained in a fixed position by a gastro-gastric suture or staple for inserting the device into the gastric wall. Advantageously, the volume filling device has a perimeter that changes to be better maintained in a fixed position when it is inserted into the patient's gastric wall. The gastro-gastric suture or staple may be provided with a fixing portion adapted to form a structure that contacts the gastric wall to promote the internal growth of human tissue and fix the position of the volume filling device attached to the gastric wall for a long time. This structure may include a net-like structure.

[0189] In an embodiment of the present invention, the device further has an expansion device disposed outside the gastric wall and adapted to expand a portion of the gastric wall to affect the patient's appetite. The volume filling de In an embodiment of the present invention, the device further has an expansion device disposed outside the gastric wall and adapted to expand a portion of the gastric wall to affect the patient's appetite. The volume filling de When the vice is inflatable, the device may have a fluid connection that interconnects the expansion device and the volume filling device.

[0190] (Summary) In one embodiment, the device includes an expansion device that includes at least one operable expansion device adapted to expand a portion of the patient's gastric wall and implantable within an obese patient, and an operating device for operating the expansion device to expand the gastric wall portion and thereby provide a feeling of fullness when implanted.

[0191] In one embodiment, the device includes at least one operable expansion device adapted to expand a portion of the patient's gastric wall and implantable within the patient, and a implantable control unit for automatically controlling the operable expansion device to expand the gastric wall portion related to the patient's eating and provide a feeling of fullness when implanted together with the expansion device.

[0192] In one embodiment, the device has an expansion device that includes at least one operable expansion device adapted to expand a portion of the patient's gastric wall and implantable within an obese patient, wherein the expansion device has an expandable expansion reservoir and an operating device for operating the expansion device to expand the gastric wall portion when implanted, wherein at least the distal portion of the movement restriction device is inflatable and fluidly connected to the expansion reservoir, wherein the operating device has a pump for pumping fluid between the main reservoir and the expansion reservoir to expand the gastric wall portion and provide a sense of satisfaction. A control device for controlling the expansion device including the pump may be provided. ​​​​​​​​​​The control device is adapted to control the expansion device from outside the patient's body with a wire harness remote control device or a implantable control unit for controlling the expansion device can have. Alternatively, the control device may have a subcutaneous switch or a reservoir adapted to control the expansion device from outside the patient's body. A sensor or sensing device implanted within the patient's body may be provided, and the implantable control unit is adapted to control the expansion device from inside the patient's body using information from the sensor or sensing device adapted to directly or indirectly sense that the patient has ingested food. In one embodiment, the distal portion of the movement restriction device has a main volume filling reservoir and an expansion device including at least one operable expansion device implantable within an obese patient adapted to expand a portion of the patient's gastric wall, where the expansion device has an inflatable reservoir adapted to be recessed into the gastric wall at a location in the upper portion of the stomach that is higher than the main volume filling device that is inflatable when the patient is standing, where the volume filling device is inflatable and is fluidly connected to the expansion reservoir, where fluid flows out of the recessed main volume filling reservoir disposed in the lower portion of the gastric wall adapted to expand the gastric wall portion to the expansion reservoir to provide a feeling of fullness in relation to the normal contraction of the gastric wall as food is ingested. The fluid 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 is for returning to the main volume filling reservoir the volume of the expansion reservoir

[0193] ​​​​​​​​​​​​​ It has a release function adapted to release. The release function is such that the gastric wall portion is as described above In order to release the expansion of the gastric wall portion, the fluid is slowly returned from the expansion reservoir to the main volume filling device reservoir It may have a fluid return connection portion with a substantially smaller area than the fluid connection portion, so that it is released. In order to additionally act on the expander for expanding the gastric wall portion Another manually controlled device having a reservoir disposed subcutaneously and adapted to control the expander from outside the patient's body may be provided. In one embodiment, a main volume filling reservoir adapted to be expandable may be provided Here, the distal portion of the movement restricting device further has an expandable structure adapted to expand when the device is indented into the gastric wall

[0194] Here, the structure has a bellows adapted to take into account the occurrence of fibrosis around the device when implanted so that the bellows movement is substantially unaffected by fibrosis.

[0195]

[0195] In one embodiment, the device has an expander including at least one operable expander adapted to expand a portion of the patient's gastric wall and implantable in an obese patient Here, the expander has an expandable structure adapted to expand the gastric wall portion when the device is indented into the gastric wall Here, the structure has a special bellows adapted to take into account the occurrence of fibrosis around the device when implanted so that the bellows movement is substantially unaffected by the fibrosis. In order to expand the gastric wall portion to give a feeling of fullness An operation device for operating the expander is provided. A vice may be provided. When the device is implanted together with the expansion device, it automatically controls an operable expansion device to expand the gastric wall portion related to the patient's eating to give a feeling of fullness. It can have an implantable control unit that controls the expansion device automatically.

[0196] In one embodiment, the device includes an expansion device including at least one operable expansion device that is adapted to expand a portion of the patient's gastric wall to give a feeling of fullness and is implantable among obese patients. This control device can have a wireless remote control device adapted to control the expansion device from outside the patient's body or an implantable control unit for controlling the above expansion device. Alternatively, the control device may have a switch disposed 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 in the patient's body may be provided, and the implantable control unit is adapted to control the expansion device from inside the patient's body using information from the sensor or sensing device adapted to directly or indirectly sense that the patient has taken in food.

[0197] In one embodiment, the device is adapted to treat reflux disease. For this purpose, the device further has an implantable movement restriction device having an elongated shape with a proximal portion and a distal portion. The proximal portion is adapted to be at least partially recessed by the wall of the patient's gastric fundus and has an outer surface including a biocompatible material. A substantial portion of the outer surface of the proximal portion of the movement restriction device is in contact with at least the patient's diaphragm and the lower portion of the wall of the recessed gastric fundus. Stationary facing the gastric wall at a certain position between it and a part so as not to damage the gastric wall is adapted such that when the proximal portion of the movement restricting device is indented the cardiac incisure of the patient's stomach is restricted from moving towards the patient's diaphragm, whereby the cardiac orifice is prevented from sliding through the patient's diaphragm which is open into the patient's thoracic cavity, and the support pressure on the patient's cardiac sphincter extending from the patient's abdomen is maintained. The proximal portion of the movement restricting device is at least 125 mm in size and has a perimeter of at least 15 mm The distal portion stabilizes and holds the proximal portion and is adapted to be substantially indented within the gastric wall 3

[0198] In another embodiment, the device is adapted to treat reflux disease. For this purpose, the device further comprises an elongated shaped implantable movement restricting device having a proximal portion and a distal portion and an outer surface including a biocompatible material. The proximal portion of the movement restricting device is adapted to be stationary facing the wall of the gastric fundus at a certain position between the patient's diaphragm and the wall of the gastric fundus such that at least a portion of its outer surface when the movement restricting device is implanted in the patient, the cardiac incisure of the patient's stomach is restricted from moving towards the patient's diaphragm, whereby the cardiac orifice is prevented from sliding through the patient's diaphragm which is open into the patient's thoracic cavity, and the support pressure on the patient's cardiac sphincter extending from the patient's abdomen is maintained. Here, the proximal portion of the movement restricting device is at least 125 mm in size and has a perimeter of at least 15 mm. An attachment device is provided such that the movement restricting device moves 3 ize and has a perimeter of at least 15 mm. An attachment device causes the movement restricting device to move ​​​​adapted to fix the proximal portion of the movement restriction device in the above position when implanted . The distal portion stabilizes and holds the proximal portion and is also adapted to substantially sink into the stomach wall .

[0199] In another embodiment, the device is adapted to treat reflux disease. For this purpose, the device further comprises a proximal portion and a distal portion and has an elongated shaped implantable movement restriction device having an outer surface including a biocompatible material, the proximal portion being adapted to be at least partially sunk into the wall of the patient's gastric fundus. A substantial portion of the outer surface of the proximal portion of the movement restriction device faces and is adapted to rest against the stomach wall at a position between at least a portion of the patient's diaphragm and at least a portion of the lower side of the wall of the sunken gastric fundus without damaging the stomach wall, so that when the movement restriction device is implanted, the cardiac notch of the patient's stomach is restricted from moving towards the patient's diaphragm, thereby preventing the cardiac sphincter from sliding through the patient's diaphragm which is open into the patient's thoracic cavity, maintaining the support pressure on the patient's cardiac sphincter extending from the patient's abdomen, and the movement restriction device has a size of at least 1 25 mm and a perimeter of at least 15 mm, and further comprises at least one operable expansion device adapted to expand a portion of the patient's stomach wall to provide a feeling of fullness and be implantable in an obese patient . The distal portion stabilizes and holds the proximal portion and is adapted to substantially sink into the stomach wall . . 25mm 3 and has a perimeter of at least 15 mm, and is further adapted to expand a portion of the patient's stomach wall to provide a feeling of fullness and be implantable in an obese patient including at least one operable expansion device. The distal portion stabilizes and holds the proximal portion and is adapted to substantially sink into the stomach wall . .

[0200] In another embodiment, the device is adapted to treat reflux disease. For this purpose, the device The device further has an elongated, transplantable movement restriction device having a proximal portion and a distal portion and an outer surface containing a biocompatible material. The proximal portion of the movement restriction device is adapted such that at least a portion of its outer surface rests facing the wall of the gastric fundus at a location between the patient's diaphragm and the wall of the gastric fundus, such that when the movement restriction device is implanted in the patient, the cardiac incisure of the patient's stomach is restricted from moving towards the patient's diaphragm, thereby preventing the cardiac orifice from sliding through the patient's diaphragm that is open into the patient's thoracic cavity, and maintaining a support pressure on the patient's cardiac sphincter extending from the patient's abdomen, where the movement restriction device has a size of at least 125 mm and a perimeter of at least 15 mm, and further has a fixation device adapted to fix the movement restriction device in the above position when the movement restriction device is implanted. The distal portion stabilizes and holds the proximal portion and is adapted to be substantially recessed within the gastric wall. The device further has an expansion device including at least one operable expansion device adapted to expand a portion of the patient's gastric wall to give a feeling of fullness and being implantable in an obese patient. In one embodiment, the device further has an expansion device including three or more mechanical parts each engaged to a different portion of the gastric wall, where the engagement includes suturing or stapling to the gastric wall or inserting the mechanical parts into the gastric wall with gastro-gastric sutures, where the three or more mechanical parts are adapted to move relative to each other and further adapted to expand three different wall portions, and the expansion device further has a gastric wall portion at least a portion of whose outer surface is adapted to rest facing the wall of the gastric fundus at a position between the patient's diaphragm and the wall of the gastric fundus such that when the movement restriction device is implanted in the patient, the cardiac incisure of the patient's stomach is restricted from moving towards the patient's diaphragm thereby preventing the cardiac orifice from sliding through the patient's diaphragm that is open into the patient's thoracic cavity and maintaining a support pressure on the patient's cardiac sphincter extending from the patient's abdomen where the movement restriction device has a size of at least 125 mm and a perimeter of at least 15 mm 3 and further has a fixation device adapted to fix the movement restriction device in the above position when the movement restriction device is implanted. The distal portion stabilizes and holds the proximal portion and is adapted to be substantially recessed within the gastric wall. The device further has an expansion device including at least one operable expansion device adapted to expand a portion of the patient's gastric wall to give a feeling of fullness and being implantable in an obese patient. In one embodiment, the device further has an expansion device including three or more mechanical parts each engaged to a different portion of the gastric wall, where the engagement includes suturing or stapling to the gastric wall or inserting the mechanical parts into the gastric wall with gastro-gastric sutures, where the three or more mechanical parts are adapted to move relative to each other and further adapted to expand three different wall portions, and the expansion device further has a gastric wall portion at least a portion of whose outer surface is adapted to rest facing the wall of the gastric fundus at a position between the patient's diaphragm and the wall of the gastric fundus such that when the movement restriction device is implanted in the patient, the cardiac incisure of the patient's stomach is restricted from moving towards the patient's diaphragm thereby preventing the cardiac orifice from sliding through the patient's diaphragm that is open into the patient's thoracic cavity and maintaining a support pressure on the patient's cardiac sphincter extending from the patient's abdomen where the movement restriction device has a size of at least 125 mm

[0201] In one embodiment, the device further has an expansion device including three or more mechanical parts each engaged to a different portion of the gastric wall, where the engagement includes suturing or stapling to the gastric wall or inserting the mechanical parts into the gastric wall with gastro-gastric sutures, where the three or more mechanical parts are adapted to move relative to each other and further adapted to expand three different wall portions, and the expansion device further has a gastric wall portion at least a portion of whose outer surface is adapted to rest facing the wall of the gastric fundus at a position between the patient's diaphragm and the wall of the gastric fundus such that when the movement restriction device is implanted in the patient, the cardiac incisure of the patient's stomach is restricted from moving towards the patient's diaphragm thereby preventing the cardiac orifice from sliding through the patient's diaphragm that is open into the patient's thoracic cavity and maintaining a support pressure on the patient's cardiac sphincter extending from the patient's abdomen The forces used to expand, the time during which the expansion is carried out, and all of the timing at which the expansion is carried out are considered, and the plurality of wall portions are adapted to expand independently of each other.

[0202] In one embodiment, the device further has an expansion device including two or more hydraulic parts each engaged with a different part of the stomach wall, where the engagement may include suturing or stapling the hydraulic part to the stomach wall or inserting the hydraulic part into the stomach wall part by a gastro-gastric suture, and where the two or more hydraulic parts are adapted to move relative to each other and are further adapted to expand three different wall portions, and the expansion device is further adapted to expand the plurality of wall portions independently of each other considering all of the forces used to expand the stomach wall part, the time during which the expansion is carried out, and the timing at which the expansion is carried out. The forces used to expand the stomach wall part, the time during which the expansion is carried out, and all of the timing at which the expansion is carried out are considered, and the plurality of wall portions are adapted to expand independently of each other.

[0203] In one embodiment, the device further has an expansion device engaged with a part of the stomach wall, which includes suturing or stapling the expansion device to the stomach wall or inserting the expansion device into the stomach wall part by a gastro-gastric suture, and where the expansion device is further adapted to expand the stomach wall part while controlling the force used to expand the stomach wall part, the time during which the expansion is carried out, and the timing at which the expansion is carried out. The forces used to expand the stomach wall part, the time during which the expansion is carried out, and all of the timing at which the expansion is carried out are considered, and the plurality of wall portions are adapted to expand independently of each other.

[0204] In one embodiment, the device further has an expansion device including two parts each engaged with a different part of the stomach wall, where the engagement may include suturing or stapling these parts to the stomach wall or inserting these parts into the stomach wall part by a gastro-gastric suture. including causing, wherein the expansion device is further used to expand the gastric wall portion while controlling the force, the time during which the expansion is performed, and the timing at which the expansion is performed, different wall portions are adapted to be expanded independently of each other.

[0205] In one embodiment, the device further has 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 device adapted to control the device from outside the patient's body. Alternatively, the extracorporeal control unit may have a subcutaneous switch or a reservoir adapted to control the device from outside the patient's body. from outside the patient's body. The extracorporeal control unit may have a wireless remote control device adapted to control the device from outside the patient's body. Alternatively, the extracorporeal control unit may have a subcutaneous switch or a reservoir adapted to control the device from outside the patient's body. Alternatively, the extracorporeal control unit may have a subcutaneous switch or a reservoir adapted to control the device from outside the patient's body. The extracorporeal control unit may have a subcutaneous switch or a reservoir adapted to control the device from outside the patient's body.

[0206] In one embodiment, the device further has a sensor or sensing device adapted to be implanted in the patient's body, wherein the implantable control unit is adapted to control the device from inside the patient's body using information from the sensor or sensing device adapted to directly or indirectly sense that the patient has ingested food. wherein the implantable control unit is adapted to control the device from inside the patient's body using information from the sensor or sensing device adapted to directly or indirectly sense that the patient has ingested food. from the sensor or sensing device adapted to directly or indirectly sense that the patient has ingested food. from the sensor or sensing device adapted to directly or indirectly sense that the patient has ingested food.

[0207] According to another aspect of the present invention, there is provided a device for treating reflux disease and obesity in an obese patient having a stomach with a hood cavity, the device having an implantable movement restriction device including a proximal portion and a distal portion, wherein the distal portion is adapted to be at least substantially recessed into the patient's gastric wall portion and further has an outer surface including a biocompatible material, wherein the distal portion of the movement restriction device is adapted to be disposed inside the stomach in a stationary state with the outer surface of the volume filling device facing the inside of the gastric wall, such that the hood cavity has an implantable movement restriction device including a proximal portion and a distal portion. wherein the distal portion is adapted to be at least substantially recessed into the patient's gastric wall portion and further has an outer surface including a biocompatible material. wherein the distal portion is adapted to be at least substantially recessed into the patient's gastric wall portion and further has an outer surface including a biocompatible material. wherein the distal portion of the movement restriction device is adapted to be disposed inside the stomach in a stationary state with the outer surface of the volume filling device facing the inside of the gastric wall. wherein the distal portion of the movement restriction device is adapted to be disposed inside the stomach in a stationary state with the outer surface of the volume filling device facing the inside of the gastric wall. The volume size of The distal portion of the movement limiting device has a maximum perimeter of at least 30 millimeters.

[0208] Note that any embodiment or part of an embodiment, feature or method or related system described herein, or part of a system, can be combined in any combination. It should be noted.

[0209] Next, the present invention will be described in more detail using non-limiting examples with reference to the accompanying drawings. It will be described.

Brief Description of the Drawings

[0210]

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DETAILED DESCRIPTION OF THE INVENTION

[0211] (Movement restriction device) FIG. 1A is a schematic view showing an apparatus 11 for treating retrograde diseases according to the present invention, including a movement restriction device 10 of a biocompatible material, implanted in a human patient. In FIG. 1A, the device 10 is recessed at the base. The device 10 has a body 13 with an outer surface 15 suitable for resting facing a portion of the outer wall 16a of the wall 16 of the gastric fundus at a position between at least a portion of the lower part of the wall of the gastric fundus and the patient's diaphragm 18. Thus, when the device 10 is recessed in such a manner, the cardiac notch of the patient's stomach is restricted from moving towards the patient's diaphragm, thereby preventing the cardiac orifice from sliding through the patient's diaphragm that is open into the patient's thoracic cavity 20, and maintaining the support pressure on the patient's cardiac sphincter extending from the patient's abdomen. , FIG. 1A is a schematic view showing an apparatus 11 for treating retrograde diseases according to the present invention, including a movement restriction device 10 of a biocompatible material, implanted in a human patient. In FIG. 1A, the device 10 is recessed at the base. The device 10 has a body 13 with an outer surface 15 suitable for resting facing a portion of the outer wall 16a of the wall 16 of the gastric fundus at a position between at least a portion of the lower part of the wall of the gastric fundus and the patient's diaphragm 18. Thus, when the device 10 is recessed in such a manner, the cardiac notch of the patient's stomach is restricted from moving towards the patient's diaphragm, thereby preventing the cardiac orifice from sliding through the patient's diaphragm that is open into the patient's thoracic cavity 20, and maintaining the support pressure on the patient's cardiac sphincter extending from the patient's abdomen. The device 10 is recessed at the base. The device 10 has a body 13 with an outer surface 15 suitable for resting facing a portion of the outer wall 16a of the wall 16 of the gastric fundus at a position between at least a portion of the lower part of the wall of the gastric fundus and the patient's diaphragm 18. Thus, when the device 10 is recessed in such a manner, the cardiac notch of the patient's stomach is restricted from moving towards the patient's diaphragm, thereby preventing the cardiac orifice from sliding through the patient's diaphragm that is open into the patient's thoracic cavity 20, and maintaining the support pressure on the patient's cardiac sphincter extending from the patient's abdomen. The device 10 is recessed at the base. The device 10 has a body 13 with an outer surface 15 suitable for resting facing a portion of the outer wall 16a of the wall 16 of the gastric fundus at a position between at least a portion of the lower part of the wall of the gastric fundus and the patient's diaphragm 18. Thus, when the device 10 is recessed in such a manner, the cardiac notch of the patient's stomach is restricted from moving towards the patient's diaphragm, thereby preventing the cardiac orifice from sliding through the patient's diaphragm that is open into the patient's thoracic cavity 20, and maintaining the support pressure on the patient's cardiac sphincter extending from the patient's abdomen. The device 10 has a body 13 with an outer surface 15 suitable for resting facing a portion of the outer wall 16a of the wall 16 of the gastric fundus at a position between at least a portion of the lower part of the wall of the gastric fundus and the patient's diaphragm 18. Thus, when the device 10 is recessed in such a manner, the cardiac notch of the patient's stomach is restricted from moving towards the patient's diaphragm, thereby preventing the cardiac orifice from sliding through the patient's diaphragm that is open into the patient's thoracic cavity 20, and maintaining the support pressure on the patient's cardiac sphincter extending from the patient's abdomen. The device 10 has a body 13 with an outer surface 15 suitable for resting facing a portion of the outer wall 16a of the wall 16 of the gastric fundus at a position between at least a portion of the lower part of the wall of the gastric fundus and the patient's diaphragm 18. Thus, when the device 10 is recessed in such a manner, the cardiac notch of the patient's stomach is restricted from moving towards the patient's diaphragm, thereby preventing the cardiac orifice from sliding through the patient's diaphragm that is open into the patient's thoracic cavity 20, and maintaining the support pressure on the patient's cardiac sphincter extending from the patient's abdomen. Thus, when the device 10 is recessed in such a manner, the cardiac notch of the patient's stomach is restricted from moving towards the patient's diaphragm, thereby preventing the cardiac orifice from sliding through the patient's diaphragm that is open into the patient's thoracic cavity 20, and maintaining the support pressure on the patient's cardiac sphincter extending from the patient's abdomen. Thus, when the device 10 is recessed in such a manner, the cardiac notch of the patient's stomach is restricted from moving towards the patient's diaphragm, thereby preventing the cardiac orifice from sliding through the patient's diaphragm that is open into the patient's thoracic cavity 20, and maintaining the support pressure on the patient's cardiac sphincter extending from the patient's abdomen. Thus, when the device 10 is recessed in such a manner, the cardiac notch of the patient's stomach is restricted from moving towards the patient's diaphragm, thereby preventing the cardiac orifice from sliding through the patient's diaphragm that is open into the patient's thoracic cavity 20, and maintaining the support pressure on the patient's cardiac sphincter extending from the patient's abdomen.

[0212] The body 13 is inflatable and adapted to be inflated by a gel or a fluid. A fluid or gel containing member for receiving the fluid for inflating the above-described movement restriction device may be provided. Alternatively, the body 13 may include a homogeneous material and may be a solid body. Alternatively, the body 13 includes an outer wall in the form of an enclosure wall defining a chamber. This outer wall may be rigid, elastic or flexible. When the outer wall is rigid, the outer wall is such that the stomach moves The body 13 is inflatable and adapted to be inflated by a gel or a fluid. A fluid or gel containing member for receiving the fluid for inflating the above-described movement restriction device may be provided. Alternatively, the body 13 may include a homogeneous material and may be a solid body. Alternatively, the body 13 includes an outer wall in the form of an enclosure wall defining a chamber. This outer wall may be rigid, elastic or flexible. When the outer wall is rigid, the outer wall is such that the stomach moves The body 13 is inflatable and adapted to be inflated by a gel or a fluid. A fluid or gel containing member for receiving the fluid for inflating the above-described movement restriction device may be provided. Alternatively, the body 13 may include a homogeneous material and may be a solid body. Alternatively, the body 13 includes an outer wall in the form of an enclosure wall defining a chamber. This outer wall may be rigid, elastic or flexible. When the outer wall is rigid, the outer wall is such that the stomach moves The body 13 is inflatable and adapted to be inflated by a gel or a fluid. A fluid or gel containing member for receiving the fluid for inflating the above-described movement restriction device may be provided. Alternatively, the body 13 may include a homogeneous material and may be a solid body. Alternatively, the body 13 includes an outer wall in the form of an enclosure wall defining a chamber. This outer wall may be rigid, elastic or flexible. When the outer wall is rigid, the outer wall is such that the stomach moves The body 13 is inflatable and adapted to be inflated by a gel or a fluid. A fluid or gel containing member for receiving the fluid for inflating the above-described movement restriction device may be provided. Alternatively, the body 13 may include a homogeneous material and may be a solid body. Alternatively, the body 13 includes an outer wall in the form of an enclosure wall defining a chamber. This outer wall may be rigid, elastic or flexible. When the outer wall is rigid, the outer wall is such that the stomach moves It has a high rigidity such that it can maintain a state of not deforming even when receiving the generated force.

[0213] The main body 13 of the movement restriction device 10 can be attached to the wall 16a of the base portion 16 by various different methods. In the embodiment shown in FIG. 1A, the device 10 is inserted from the outside of the stomach into the stomach wall of the base portion. After insertion, a first fixing device composed of a plurality of stomach-stomach sutures or staples 22a is applied to maintain the insertion in a complete state for a short time. This enables the growth of human tissue to maintain the insertion in a complete state over a long period.

[0214] Optionally, to hold the device 10 at the above position between the patient's diaphragm 18 and at least a part of the lower portion of the wall 16 of the inserted stomach base, a second fixing device composed of a plurality of sutures or staples 22b provided between the wall 16a of the base portion 16 and the wall 24a of the esophagus 24 may be present. In this case, the device 10 is attached to this position by this second fixing device. The device 10 may be directly or indirectly attached to the diaphragm muscle 18 or another muscle tissue. As an alternative, the device 10 may be directly or indirectly attached to the esophagus at His. Alternatively or additionally, a third fixing device in the form of sutures or staples 22c provided between the wall 16a of the base portion 16 and the diaphragm 18 may be present to hold the device 10 at the above position.

[0215] FIG. 1B shows an embodiment substantially similar to the embodiment shown in FIG. 1A. In B, the main body 13 and the recessed portion are fixed using sutures and / or staples 22c between the reflux main body 13 and the diaphragm 18 in addition to the adhesion portion 22, whereby the device is held at a position above the cardia 14.

[0216] Figure 1C shows another embodiment that is substantially similar to the embodiment shown in Figure 1A. Figure 1 In C, the anti-reflux treatment device is held in place by a gastro-gastric suture or staple 22a that connects the wall 16a of the base portion 16 to the wall 16a of the base portion 16. In addition, the anti-reflux treatment device 10 is further held in place by a suture 22b or staple from the wall 16 of the base portion 16a to the wall of the esophagus 24a, and furthermore, by a suture or staple from the wall of the base portion 16a to the diaphragm.

[0217] An alternative embodiment of the device 17 for treating reflux disease according to the present invention is shown in Figure 2A. This embodiment is similar in many respects to the embodiments described above with reference to Figures 1A - C. Thus, the movement restriction device 10 is shown implanted into a human patient and recessed within the base portion. However, in the embodiment shown in Figure 2A, the device 10 is recessed from the inside of the stomach instead of being recessed from the outside of the stomach as in the case of Figures 1A - C. The movement restriction device 10 has a main body 13 that is adapted to rest facing a portion of the inner wall of the wall 16 of the gastric base at a position between at least a portion of the diaphragm 18 of the patient and the lower portion of the wall 16 of the recessed gastric base. In this embodiment, the main body 13 is positioned above the cardia region 14 of a standing human or mammalian patient. The main body 13 of the device 10 is based ​​​​​​It is shaped to rest facing the wall 16a of the base 16, and further, it has an outer surface 15 suitable for resting facing the wall of this base portion. Thus, when the device 10 is recessed in such a form as described above in relation to FIG. 1A, the cardiac incisure of the patient's stomach is restricted from moving towards the patient's diaphragm, whereby the cardiac orifice is prevented from sliding through the patient's diaphragm that is open into the patient's thoracic cavity 20, and the support pressure on the cardiac sphincter extending from the patient's abdomen is maintained. And has an outer surface 15 suitable for resting facing this wall of the base portion. Thus, when the device 10 is recessed in such a form as described above in relation to FIG. 1A, the cardiac incisure of the patient's stomach is restricted from moving towards the patient's diaphragm, whereby the cardiac orifice is prevented from sliding through the patient's diaphragm that is open into the patient's thoracic cavity 20, and the support pressure on the cardiac sphincter extending from the patient's abdomen is maintained. the cardiac incisure of the patient's stomach is restricted from moving towards the patient's diaphragm, whereby the cardiac orifice is prevented from sliding through the patient's diaphragm that is open into the patient's thoracic cavity 20, and the support pressure on the cardiac sphincter extending from the patient's abdomen is maintained. the cardiac incisure of the patient's stomach is restricted from moving towards the patient's diaphragm, whereby the cardiac orifice is prevented from sliding through the patient's diaphragm that is open into the patient's thoracic cavity 20, and the support pressure on the cardiac sphincter extending from the patient's abdomen is maintained. the cardiac incisure of the patient's stomach is restricted from moving towards the patient's diaphragm, whereby the cardiac orifice is prevented from sliding through the patient's diaphragm that is open into the patient's thoracic cavity 20, and the support pressure on the cardiac sphincter extending from the patient's abdomen is maintained.

[0218] After the recession, a plurality of gastric-gastric sutures or staples 33a including the first fixing device are applied from the inside of the stomach 16 to maintain the recessed portion in a complete state for a short time. Thereby, it becomes possible to grow human tissue in order to maintain the recessed portion in a complete state over a long period of time. Additional sutures or staples 22b including the second fixing device may be provided between the wall portion 16b of the base 16 forming a part of the recessed portion of the device 10 and the wall 24a of the esophagus 24 in order to hold the device 10 in the above position. Similarly, a third fixing device in the form of a suture or staple 22c may be provided between another wall portion 16c of the base 16 forming a part of the recessed portion of the device 10 and the diaphragm 18 in order to hold the device 10 in the above position. After the recession, a plurality of gastric-gastric sutures or staples 33a including the first fixing device are applied from the inside of the stomach 16 to maintain the recessed portion in a complete state for a short time. Thereby, it becomes possible to grow human tissue in order to maintain the recessed portion in a complete state over a long period of time. After the recession, a plurality of gastric-gastric sutures or staples 33a including the first fixing device are applied from the inside of the stomach 16 to maintain the recessed portion in a complete state for a short time. Thereby, it becomes possible to grow human tissue in order to maintain the recessed portion in a complete state over a long period of time. Additional sutures or staples 22b including the second fixing device may be provided between the wall portion 16b of the base 16 forming a part of the recessed portion of the device 10 and the wall 24a of the esophagus 24 in order to hold the device 10 in the above position. Similarly, a third fixing device in the form of a suture or staple 22c may be provided between another wall portion 16c of the base 16 forming a part of the recessed portion of the device 10 and the diaphragm 18 in order to hold the device 10 in the above position. Additional sutures or staples 22b including the second fixing device may be provided between the wall portion 16b of the base 16 forming a part of the recessed portion of the device 10 and the wall 24a of the esophagus 24 in order to hold the device 10 in the above position. Similarly, a third fixing device in the form of a suture or staple 22c may be provided between another wall portion 16c of the base 16 forming a part of the recessed portion of the device 10 and the diaphragm 18 in order to hold the device 10 in the above position. Additional sutures or staples 22b including the second fixing device may be provided between the wall portion 16b of the base 16 forming a part of the recessed portion of the device 10 and the wall 24a of the esophagus 24 in order to hold the device 10 in the above position. Similarly, a third fixing device in the form of a suture or staple 22c may be provided between another wall portion 16c of the base 16 forming a part of the recessed portion of the device 10 and the diaphragm 18 in order to hold the device 10 in the above position. Additional sutures or staples 22b including the second fixing device may be provided between the wall portion 16b of the base 16 forming a part of the recessed portion of the device 10 and the wall 24a of the esophagus 24 in order to hold the device 10 in the above position. Similarly, a third fixing device in the form of a suture or staple 22c may be provided between another wall portion 16c of the base 16 forming a part of the recessed portion of the device 10 and the diaphragm 18 in order to hold the device 10 in the above position. Additional sutures or staples 22b including the second fixing device may be provided between the wall portion 16b of the base 16 forming a part of the recessed portion of the device 10 and the wall 24a of the esophagus 24 in order to hold the device 10 in the above position. Similarly, a third fixing device in the form of a suture or staple 22c may be provided between another wall portion 16c of the base 16 forming a part of the recessed portion of the device 10 and the diaphragm 18 in order to hold the device 10 in the above position. Additional sutures or staples 22b including the second fixing device may be provided between the wall portion 16b of the base 16 forming a part of the recessed portion of the device 10 and the wall 24a of the esophagus 24 in order to hold the device 10 in the above position. Similarly, a third fixing device in the form of a suture or staple 22c may be provided between another wall portion 16c of the base 16 forming a part of the recessed portion of the device 10 and the diaphragm 18 in order to hold the device 10 in the above position.

[0219] Another embodiment is shown in FIG. 2B. This embodiment is very similar in many respects to the embodiment described with reference to FIG. 2A. However, here, all of the sutures and staples 22b and 33a are connected to the fixing device of the anti-reflux treatment device 10. In this embodiment, there are no gastric-diaphragm sutures or staples. Another embodiment is shown in FIG. 2B. This embodiment is very similar in many respects to the embodiment described with reference to FIG. 2A. However, here, all of the sutures and staples 22b and 33a are connected to the fixing device of the anti-reflux treatment device 10. In this embodiment, there are no gastric-diaphragm sutures or staples. Another embodiment is shown in FIG. 2B. This embodiment is very similar in many respects to the embodiment described with reference to FIG. 2A. However, here, all of the sutures and staples 22b and 33a are connected to the fixing device of the anti-reflux treatment device 10. In this embodiment, there are no gastric-diaphragm sutures or staples. Another embodiment is shown in FIG. 2B. This embodiment is very similar in many respects to the embodiment described with reference to FIG. 2A. However, here, all of the sutures and staples 22b and 33a are connected to the fixing device of the anti-reflux treatment device 10. In this embodiment, there are no gastric-diaphragm sutures or staples.

[0220] As an alternative form, an apparatus 19 for treating reflux disease is shown in FIG. 3A. This alternative form is similar in many respects to the embodiments described above with reference to FIGS. 1A - C and 2A - B. Accordingly, the movement - restricting device 10 is shown implanted within a human patient. The device 10 has a body 13 adapted to rest facing a portion of the wall 16 of the gastric fundus at a position between the patient's diaphragm 18 and the wall 16 of the gastric fundus. However, in this alternative form, the device 10 does not protrude into the stomach 16. Instead, the attachment portion of the device 10 is adapted to contact the basal gastric wall 16a so as to promote the growth of human tissue such that a reflux - disease - treating device attached to the gastric wall is securely positioned over a long period. Preferably, it has an attachment structure 10a which is a net - like structure. That is, a first fixing device in the form of sutures or staples 44a may be provided between the attachment structure 10a and the basal wall 16a to hold the attachment structure 10a in place.

[0221] The attachment structure 10a may be adapted to a second fixing device in the form of sutures or staples 44b provided between the wall 16a of the base 16 and the wall 24a of the esophagus 24 to hold the device 10 at the above - mentioned position between the diaphragm 18 and the gastric fundus. Similarly, the attachment structure 10a may also be adapted to a third fixing device in the form of sutures or staples 44c provided between the wall 16a of the base 16 and the diaphragm 18 to hold the device 10 at the above - mentioned position.

[0222] An alternative embodiment is shown in FIG. 3B. This embodiment is described with reference to FIG. 3A. It is similar in many respects to the embodiment. In this embodiment, as in FIGS. 2A - B, the anti-reflux treatment device 10 is inserted from the inside of the stomach. The attachment structure 10a is located on the wall 16a of the base 16, above and around the insertion part formed by the anti-reflux treatment device 10 and is positioned thereon. .

[0223] An alternative embodiment of the device 21 for treating reflux disease according to the present invention is shown in FIG. 4A. This embodiment is similar in many respects to the embodiment described above with reference to FIGS. 1A - C. In FIG. 4A, a drawing of the device 10 for treating reflux disease according to the present invention is shown implanted within a human patient. In FIG. 4A, the movement restriction device 10 is also implanted in the base 16. The device 10 has a body 13 with an outer surface 15 suitable for resting at a position between the patient's diaphragm 18 and at least a part of the lower side of the wall 16 of the implanted gastric base, facing a part of the outer wall 16a of the wall 16 of the gastric base. The body 13 is shaped to rest facing the outer wall 16a of the base 16. Thus, when the device 10 is implanted in this way, the cardiac incisure of the patient's stomach is restricted from moving towards the patient's diaphragm, thereby preventing the cardiac orifice from sliding through the patient's diaphragm that is open into the patient's thoracic cavity 20, and maintaining the support pressure on the patient's cardiac sphincter extending from the patient's abdomen. and is shaped to rest facing the outer wall 16a of the base 16. Thus, when the device 10 is implanted in this way, the cardiac incisure of the patient's stomach is restricted from moving towards the patient's diaphragm, thereby preventing the cardiac orifice from sliding through the patient's diaphragm that is open into the patient's thoracic cavity 20, and maintaining the support pressure on the patient's cardiac sphincter extending from the patient's abdomen. Therefore, by being implanted in such a form, the device 10 restricts the movement of the cardiac incisure of the patient's stomach towards the patient's diaphragm, thereby preventing the cardiac orifice from sliding through the patient's diaphragm that is open into the patient's thoracic cavity 20, and maintaining the support pressure on the patient's cardiac sphincter extending from the patient's abdomen. In the embodiment of FIG. 4A, as in the embodiment of FIG. 1A, after the device 10 is implanted into the base 16, a first fixing device composed of a plurality of gastric-gastric sutures or staples 22a is applied to maintain the insertion part in a complete state for a short time. A plurality of sutures or staples 22a is applied to maintain the insertion part in a complete state for a short time.

[0224] In the embodiment of FIG. 4A, as in the embodiment of FIG. 1A, after the device 10 is implanted into the base 16, a first fixing device composed of a plurality of gastric-gastric sutures or staples 22a is applied to maintain the insertion part in a complete state for a short time. or staples 22a is applied to maintain the insertion part in a complete state for a short time. ​Or a second securing device composed of staples 22b secures the device 10 at the position between at least a portion of the lower part of the wall 16 of the sunken gastric fundus and the patient's diaphragm 18. Additionally, a third securing device in the form of a suture or staple 22c may also be provided between the wall 16a of the base 16 and the diaphragm 18 to secure the device 10 at the position as well. In the embodiment shown in FIG. 4A, the size of the movement restriction device 10 can be adjusted during transplantation. The device 10 is connected to a hydraulic reservoir 52 connected to the device 10 by a lead 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.

[0225]

[0226] Furthermore, the above embodiment may also be used as an alternative method for treating obesity. In this embodiment, the device utilizes the volume of the movement restriction body 13 for containing fluid, and further one or more small chambers 10b that are filled with fluid by a pump and connected to the body 13 to expand the wall of the base to give a feeling of fullness, so as to be adapted to treat obesity. The small chambers 10b are also adapted to be recessed into the gastric wall of the base, and by being filled and expanded with fluid, human sensor feedback creates a feeling of fullness. By subcutaneously placing a small hydraulic reservoir / pump into the patient, the patient can extrude the hydraulic fluid to fill the small chambers to obtain a feeling of fullness as needed. ​​​​​​​​​​​​​​​​

[0227] An alternative embodiment is shown in FIG. 4B. This embodiment is substantially similar to the embodiment shown in FIG. 4A, but differs in the manner in which the countercurrent treatment device 10 and the chamber 10b are controlled. Here, the chamber 10b is controlled by a powered in-body control unit 56 rather than a subcutaneous pump. The in-body control unit 56 has means for the patient to control the device 10, which are used in view of treating countercurrent and / or obesity. The in-body control unit 56 also has means for powering the device. The in-body control unit 56 may have a battery 70, an electrical switch 72, a motor / pump 44, a reservoir

[0228] 52 and an infusion port 1001. An energy transmission device 34 with a remote control is adapted to control and power the device. These items are selected according to the environment, such as, for example, whether the device is electrically, hydraulically, pneumatically or mechanically actuated. The control unit can receive inputs from any sensor 76, particularly a pressure sensor. Any type of sensor may be provided. The in-body control unit 56 preferably has intelligence in the form of an FPGA or an MCU or an ASIC, or any other circuit, component or memory (see the later section "System" for a more detailed description).

[0229] or an MCU or an ASIC, or any other circuit, component or memory (see the later section "System" for a more detailed description).

[0230] FIG. 4C shows essentially the same as FIG. 4A, but differs in that there is one small chamber 10b instead of the two small chambers of FIG. 4A. FIG. 4C shows the small chamber in an empty state. shows the small chamber 10b filled and expanded to provide a feeling of fullness, and FIG. 4D shows the small chamber 10b filled and expanded to provide a feeling of fullness. shows the small chamber 10b filled and expanded to provide a feeling of fullness.

[0231] Furthermore, an alternative embodiment of the apparatus 23 for treating retrograde diseases according to the present invention is shown in FIG. 5A. This embodiment is also similar in many respects to the embodiment described above with reference to FIGS. 1A - C. Thus, similar to the embodiment of FIG. 1A, the movement restriction device 10 that is recessed into the base is at least between the patient's diaphragm 18 and at least a portion of the lower side of the wall 16 of the recessed gastric base. It is composed of a main body 13 having an outer surface 15 suitable for resting facing a portion of the outer wall 16a of the wall 16 of the gastric base. The main body 13 of the device 10 is shaped to rest facing the outer wall 16a of the base 16 and has a generally smooth outer surface 15 suitable for resting facing the wall of this base. After the device 10 is recessed into the base 16, again, in order to maintain the recessed portion in a complete state for a short time, a first fixing device composed of a plurality of gastric - gastric sutures or staples 22a is applied. A second fixing device is provided, which 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 to hold the device 10 in the above - mentioned position. In the alternative embodiment shown in FIG. 5A, the apparatus 23 further has a stimulation device 26 adapted to send out stimulation pulses to further close the cardiac sphincter to prevent retrograde diseases additionally. The apparatus 23 has at least one conductor 26a and at least one electrode bar 26b adapted to receive the stimulation pulses. After the device 10 is recessed into the base 16, again, in order to maintain the recessed portion in a complete state for a short time, a first fixing device composed of a plurality of gastric - gastric sutures or staples 22a is applied. A second fixing device is provided, which 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 to hold the device 10 in the above - mentioned position. In the alternative embodiment shown in FIG. 5A, the apparatus 23 further has a stimulation device 26 adapted to send out stimulation pulses to further close the cardiac sphincter to prevent retrograde diseases additionally. The apparatus 23 has at least one conductor 26a and at least one electrode bar 26b adapted to receive the stimulation pulses.

[0232] In the alternative embodiment shown in FIG. 5A, the apparatus 23 further has a stimulation device 26 adapted to send out stimulation pulses to further close the cardiac sphincter to prevent retrograde diseases additionally. The apparatus 23 has at least one conductor 26a and at least one electrode bar 26b adapted to receive the stimulation pulses. In the alternative embodiment shown in FIG. 5A, the apparatus 23 further has a stimulation device 26 adapted to send out stimulation pulses to further close the cardiac sphincter to prevent retrograde diseases additionally. The apparatus 23 has at least one conductor 26a and at least one electrode bar 26b adapted to receive the stimulation pulses.

[0233] The stimulation device 26 preferably has an electronic circuit and, in a preferred embodiment, an energy source provided within the device 10. with.

[0234] The stimulation device 26 preferably sends stimulation pulses as a series of pulses, where the pulse train is adapted to be repeated with a time break in between, and this break extends the break between each pulse of the pulse train.

[0235] Figure 5B shows an embodiment essentially the same as that of Figure 5A, but with the addition of an in-body control unit 56, a remote control device 28, and an extracorporeal energy transmission device 34. The in-body control unit 56 is connected to the stimulation device by a power lead 56b. The in-body control unit 57 can have a battery 70, an electrical switch 72, and other components to be described later in the "System" section. with.

[0236] According to one embodiment of the present invention, the retrograde disease treatment device 10 may be formed as a generally oval body as shown in Figure 6A. The retrograde disease treatment device 10, according to another embodiment of the present invention, may be formed as an oval or spherical body with a concave center as shown in Figure 6B. The retrograde disease treatment device 10, according to yet another embodiment of the present invention, may be formed as a slightly curved oval body as shown in Figure 6 C. C.

[0237] According to another embodiment of the present invention, the retrograde disease treatment device 10 may be formed as a generally spherical body as shown in Figure 6D. with.

[0238] As discussed above, the anti-reflux treatment device 10 is fixed at a position above the esophagus of a standing patient. For this purpose, an embodiment of the anti-reflux treatment shown in FIG. 7 has a fixing device 10d that can function, for example, as an attachment position for a suture or a staple. This fixing device may be a curved portion or a raised portion with or without holes, or may have any other arbitrary shape that makes this fixing device suitable for fixing the anti-reflux treatment device 10.

[0239] FIG. 8 shows an embodiment of the anti-reflux treatment device 10, where the anti-reflux treatment device 10 is adjustable by hydraulic means, and 10e is an injection port that can receive a hydraulic fluid to expand the device. Alternatively, in one embodiment, the anti-reflux treatment device 10 may be inflated from a small size to a large size during a surgical procedure, for example, when it is advantageous for the device to be initially small in a laparoscopic procedure. In this embodiment, any filling material, solid, liquid or gas, may be injected through the injection port 10e to bring the anti-reflux treatment device 10 to its final shape.

[0240] FIG. 9 shows an embodiment where the anti-reflux treatment device 10 has a raised portion 10f with a depression adapted to be held by a surgical instrument. This is used, for example, when the anti-reflux treatment device is implanted during a surgical procedure.

[0241] If the anti-reflux disease device 10 is generally spherical and thus the anti-reflux treatment device 10 can completely or partially surround the esophagus, the anti-reflux disease treatment device 1 ​​​​​​​​​​​The inner diameter D of 0 is preferably sized such that it can surround at least a portion of the esophagus and the base, such that when the device is implanted, it comes into direct contact with the wall of the esophagus and does not remain stationary.

[0242] The movement restriction device 10 can take any conforming shape that allows the device 10 to rest in a position where the cardial incisure of the patient's stomach does not move towards the patient's diaphragm, such that the cardia is prevented from sliding through the patient's diaphragm that is open into the patient's thoracic cavity and the support pressure on the patient's cardiac sphincter extending from the patient's abdomen is maintained.

[0243] (System) Next, referring to FIGS. 10 - 27, an energy and operation system generally designated 28 incorporated in the device according to the present invention will be described.

[0244] The system 28 shown in FIG. 10 has an implantable energy conversion device 30 in the form of a body energy source adapted to supply energy to the energy consuming elements of the anti-reflux disease treatment device via a power supply line 32. An external energy transmission device 34 has a wireless remote control device that transmits a wireless signal received by a signal receiver that may be incorporated into or separate from the implantable energy transmission device 30. The implantable energy transmission device 30 converts the energy from the signal into electrical energy supplied via the power supply line 32.

[0245] The system 28 of FIG. 10 is shown in a more schematic block diagram form in FIG. 11, where the patient's skin 36, generally shown by a vertical line, is the interior of the patient 29 to the right of the line and the ​​​​​​​​​​It separates from the outside on the left side.

[0246] FIG. 11 shows a simplified block diagram showing the movement restriction device 10, the energy conversion device 30 that supplies power to the device 10 via the power supply line 32, and the extracorporeal energy transmission device 34. It shows a simplified block diagram showing the movement restriction device 10, the energy conversion device 30 that supplies power to the device 10 via the power supply line 32, and the extracorporeal energy transmission device 34.

[0247] FIG. 12 shows an embodiment of the present invention that is the same as the embodiment of FIG. 11, except that a reversing device in the form of an electric switch 38 that can be operated by polarized energy is further implanted into the patient 29 to reverse the device 10. The wireless remote control device of the extracorporeal energy transmission device 34 transmits a wireless signal that carries polarized energy, and the implanted energy conversion device 30 converts the polarized wireless energy into a polarized current for operating the electric switch 38. When the polarity of the current is changed by the implanted energy conversion device 30, the electric switch 38 reverses the function performed by the device 10. The wireless remote control device of the extracorporeal energy transmission device 34 transmits a wireless signal that carries polarized energy, and the implanted energy conversion device 30 converts the polarized wireless energy into a polarized current for operating the electric switch 38. The wireless remote control device of the extracorporeal energy transmission device 34 transmits a wireless signal that carries polarized energy, and the implanted energy conversion device 30 converts the polarized wireless energy into a polarized current for operating the electric switch 38. When the polarity of the current is changed by the implanted energy conversion device 30, the electric switch 38 reverses the function performed by the device 10. When the polarity of the current is changed by the implanted energy conversion device 30, the electric switch 38 reverses the function performed by the device 10.

[0248] FIG. 13 shows an embodiment of the present invention that is the same as FIG. 11, except that an operating device 40 implanted into the patient to adjust the reverse flow disease treatment device 10 is provided between the implanted energy conversion device 30 and the device 10. This operating device may be in the form of a motor 40 such as an electric servo motor. The motor 40 is powered by the energy from the implanted energy conversion device 30 when the remote control device of the extracorporeal energy transmission device 34 transmits a wireless signal to the receiver of the implanted energy conversion device 30. FIG. 13 shows an embodiment of the present invention that is the same as FIG. 11, except that an operating device 40 implanted into the patient to adjust the reverse flow disease treatment device 10 is provided between the implanted energy conversion device 30 and the device 10. This operating device may be in the form of a motor 40 such as an electric servo motor. The motor 40 is powered by the energy from the implanted energy conversion device 30 when the remote control device of the extracorporeal energy transmission device 34 transmits a wireless signal to the receiver of the implanted energy conversion device 30. The motor 40 is powered by the energy from the implanted energy conversion device 30 when the remote control device of the extracorporeal energy transmission device 34 transmits a wireless signal to the receiver of the implanted energy conversion device 30.

[0249] ​​​​​​​FIG. 14 illustrates a motor / pump unit 78 and fluid reservoir 46 that are implanted in a patient. The embodiment of FIG. 11, except that it further includes an operating device in the form of an assembly 42 including 1 shows the same embodiment of the invention as in FIG. 1, where device 10 is hydraulically operated. That is, hydraulic fluid is pumped by a motor / pump unit 44 to operate the device. The fluid is forced from the fluid reservoir 46 through the conduit 48 to the device 10 by the hydraulic Fluid is pumped by the motor / pump unit 44 to return the device 10 to the starting position. , is forced out of the device 10 and back into the fluid reservoir 46. The converter device 30 supplies power to the motor / pump unit 44 via a power supply line 50. To achieve this, the wireless energy is converted into an electric current, for example a polarized current.

[0250] Instead of a hydraulically operated movement restriction device 10, the operating device is a pneumatically operated device. In this case, pressurized air may be used for regulation. Instead, the fluid reservoir is replaced by an air chamber and the fluid is replaced by air.

[0251] In all these embodiments, the energy-transforming device 30 is a wireless energy A rechargeable accumulator, such as a battery or capacitor, is charged by the The device may be configured to supply energy to any energy consuming part of the device.

[0252] The external energy transmission device 34 is preferably wireless and is connected from outside the human body. To control the device 10, it may have a remotely controlled control device.

[0253] Such control devices may include wireless remote control devices, and most preferably, manually operated devices that are indirectly contacted by a patient's hand, for example, by pressing a button placed under the skin. For example, a manually operated device of the implanted portion that is indirectly contacted by the hand of the patient with a button placed under the skin may be included.

[0254] Figure 15 shows an embodiment of the present invention having an extracorporeal energy transmission device 34 with a wireless remote control device, a device 10 hydraulically operated herein, and an implanted energy conversion device 30. This embodiment further includes 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 within the patient. Of course, since hydraulic operation can be easily performed by simply changing the direction of the pump, the hydraulic control valve may be omitted. The remote control device may be a device separated from the extracorporeal energy transmission device or may be included within the extracorporeal energy transmission device. The motor of the motor / pump unit 44 is an electric motor. In response to a control signal from the wireless remote control device of the extracorporeal energy transmission device 34, the implanted energy conversion device 30 powers the motor / pump unit 44 using the energy conveyed by the control signal, and the motor / pump unit 44 distributes hydraulic fluid between the hydraulic fluid reservoir 52 and the device 10. There is a one-way direction in which fluid is pushed out from the hydraulic fluid reservoir 52 to the device 10 by the motor / pump unit 44 to thereby operate the device 10, and another reverse direction in which fluid is pushed back from the device 10 to the hydraulic fluid reservoir 52 by the motor / pump unit 44 to thereby return the device 10 to the starting position. Between these two directions, the hydraulic fluid The motor of the motor / pump unit 44 is an electric motor. In response to a control signal from the wireless remote control device of the extracorporeal energy transmission device 34, the implanted energy conversion device 30 powers the motor / pump unit 44 using the energy conveyed by the control signal, and the motor / pump unit 44 distributes hydraulic fluid between the hydraulic fluid reservoir 52 and the device 10. distribution occurs.​​​​​​​​​​​ To switch the flow direction, the remote control device of the extracorporeal energy transmission device 34 controls the hydraulic valve · shift · device 54.

[0255] FIG. 16 shows an embodiment of the present invention that is the same as the embodiment of FIG. 15, except that the in - body control unit 56, the accumulator 58, and the capacitor 60 controlled by the wireless remote control device of the extracorporeal energy transmission device 34 are further implanted into the patient. The in - body control unit 56 is configured to accumulate the electrical energy received from the implanted energy conversion device 30 in the accumulator 58, and the accumulator 58 supplies energy to the device 10. In response to a control signal from the wireless remote control device of the extracorporeal energy transmission device 34, the in - body control unit 56 releases electrical energy from the accumulator 58 to operate the device 10 and converts the released energy through the power lines 62 and 64, or directly converts the electrical energy from the implanted energy conversion device 30 through the power line 66, the capacitor 60 for stabilizing the current, the power line 68, and the power line 64. The in - body control unit is preferably programmable from outside the patient's body. In a preferred embodiment, the in - body control unit is programmed to adjust the device 10 to expand the stomach according to a pre - programmed time schedule, or to be input from any sensor that senses any physical parameter of the patient or any functional parameter of the device. The in - body control unit 56 is configured to accumulate the electrical energy received from the implanted energy conversion device 30 in the accumulator 58, and the accumulator 58 supplies energy to the device 10. In response to a control signal from the wireless remote control device of the extracorporeal energy transmission device 34, the in - body control unit 56 releases electrical energy from the accumulator 58 to operate the device 10 and converts the released energy through the power lines 62 and 64, or directly converts the electrical energy from the implanted energy conversion device 30 through the power line 66, the capacitor 60 for stabilizing the current, the power line 68, and the power line 64. The in - body control unit 56 is configured to accumulate the electrical energy received from the implanted energy conversion device 30 in the accumulator 58, and the accumulator 58 supplies energy to the device 10. In response to a control signal from the wireless remote control device of the extracorporeal energy transmission device 34, the in - body control unit 56 releases electrical energy from the accumulator 58 to operate the device 10 and converts the released energy through the power lines 62 and 64, or directly converts the electrical energy from the implanted energy conversion device 30 through the power line 66, the capacitor 60 for stabilizing the current, the power line 68, and the power line 64. The in - body control unit 56 is configured to accumulate the electrical energy received from the implanted energy conversion device 30 in the accumulator 58, and the accumulator 58 supplies energy to the device 10. In response to a control signal from the wireless remote control device of the extracorporeal energy transmission device 34, the in - body control unit 56 releases electrical energy from the accumulator 58 to operate the device 10 and converts the released energy through the power lines 62 and 64, or directly converts the electrical energy from the implanted energy conversion device 30 through the power line 66, the capacitor 60 for stabilizing the current, the power line 68, and the power line 64.

[0256] The in - body control unit is preferably programmable from outside the patient's body. In a preferred embodiment, the in - body control unit is programmed to adjust the device 10 to expand the stomach according to a pre - programmed time schedule, or to be input from any sensor that senses any physical parameter of the patient or any functional parameter of the device. The in - body control unit is preferably programmable from outside the patient's body. In a preferred embodiment, the in - body control unit is programmed to adjust the device 10 to expand the stomach according to a pre - programmed time schedule, or to be input from any sensor that senses any physical parameter of the patient or any functional parameter of the device. The in - body control unit is preferably programmable from outside the patient's body. In a preferred embodiment, the in - body control unit is programmed to adjust the device 10 to expand the stomach according to a pre - programmed time schedule, or to be input from any sensor that senses any physical

[0257] According to one alternative form, the capacitor 60 of the embodiment of FIG. 16 may be omitted. According to another alternative form, the accumulator 58 of this embodiment may be omitted.

[0258] FIG. 17 shows an embodiment of the present invention that is the same as the embodiment of FIG. 10, except that a battery 70 for supplying energy to operate the device 10 and an electrical switch 72 for switching the operation of the device 10 are further implanted in the patient. To switch the device 10 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, the electrical switch 72 is operated by the energy supplied by the implanted energy conversion device 30.

[0259] FIG. 18 shows an embodiment of the present invention that is the same as the embodiment of FIG. 16, except that an in-body control unit 56 that can be controlled by a wireless remote control device of the extracorporeal energy transmission device 34 is further implanted in the patient. In this case, the wireless remote control device is prevented from controlling the in-body control unit 56 and, to switch from an off-mode in which the battery is not used to a standby mode in which the remote control device can control the in-body control unit 56 so as to release electrical energy from the battery 70 to operate the device 10, the electrical switch 72 is operated by the energy supplied by the implanted energy conversion device 30.

[0260] FIG. 19 shows an embodiment of the present invention that is the same as the embodiment of FIG. 17, except that an accumulator 58 is used instead of the battery 70 and the implanted components are individually interconnected. ​​​​​​​​​​is shown. In this case, the accumulator 58 accumulates energy from the energy conversion device 30 in which it is implanted or from other sources. In response to a control signal from the wireless remote control device of the extracorporeal energy transmission device 34, the in-body control unit 56 controls the electronic switch 72, whereby the device 10 is switched from an off-mode in which the accumulator 58 is not used to an on-mode in which the accumulator 58 supplies energy to operate the device 10.

[0261] FIG. 20 shows an embodiment of the present invention that is the same as the embodiment of FIG. 18, except that a 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 device of the extracorporeal energy transmission device 34, the in-body control unit 56 controls the accumulator 58 to supply energy to operate the electrical switch 72, whereby the device 10 is switched from an off-mode in which the battery 70 is not used to an on-mode in which the battery 70 supplies electrical energy to operate the device 10. As an alternative, the wireless remote control device is prevented from controlling the battery 70 to supply electrical energy and, from an off-mode in which it is not used, the wireless remote control device is switched to a standby mode in which it can control the battery 70 to supply electrical energy to operate the device 10, whereby the electrical switch 72 may be operated by the energy supplied by the accumulator 58.

[0262] It should be understood that the switch should be interpreted in its broadest embodiment. This

[0263] ​​​​​​​, an FPGA, a DA converter, or any other electronic device or electronic circuit is preferably is controlled from outside the patient's body or by the in-body control unit while the power can be switched off and on.

[0264] Figure 21 shows an embodiment of the present invention that is the same as the embodiment of FIG. 17 except that a mechanical reverse device in the form of a motor 40 and a gear box 74, and an in-body control unit 56 for controlling the gear box 74 are further implanted into the patient. To reverse the functions performed by the device 10, the in-body control unit 56 controls (mechanically operates) the gear box 74. A simpler form is to electronically switch the direction of the motor.

[0265] Figure 22 shows an embodiment of the present invention that is the same as the embodiment of FIG. 20 except that the implanted components are individually interconnected. Thus, in this case, when the accumulator 58, preferably a capacitor, activates the electrical switch 72 to switch to the on-mode, the in-body control unit 56 is powered by the battery 70. When the electrical switch 72 is in the on-mode, the in-body control unit 56 can control the battery 70 to supply or not supply energy for operating the device 10.

[0266] Figure 23 schematically shows possible combinations of the implanted components of the device for realizing various communication options. Basically, it includes the device 10, the in-body control unit 5 6, a motor or a pump unit 44, and an external unit including an external wireless remote control device. ​​​​​​​​​There exists a wireless remote control device 34. As already explained above, the wireless remote control device transmits the control signal received by the in-body control unit 56 to control the various components implanted in the device.

[0267] A feedback device, preferably in the form of a sensor 76, may be implanted in the patient to sense the patient's physical parameters, such as the contraction wave of the esophagus indicating that the patient is eating. The in-body control unit 56, or alternatively the external energy transmission device 34 of the external wireless remote control device, can control the device 10 in response to the signal from the sensor 76. A transceiver may be combined with the sensor 76 to send information about the sensed physical parameters to the external wireless remote control device. The wireless remote control device can have a signal transmitter or transceiver, and the in-body control unit 56 can have a signal receiver or transceiver. Alternatively, the wireless remote control device can have a signal receiver or transceiver, and the in-body control unit 56 can have a signal transmitter or transceiver. The above-mentioned transceivers, transmitters, and receivers can be used to send information or data related to the device 10 from inside the patient's body to the outside.

[0268] Alternatively, the sensor 76 may be configured to sense the functional parameters of the device 10.

[0269] When the motor / pump unit 44 and the battery 70 for powering the motor / pump unit 44 are implanted, the battery 70 sends information about the state of the battery 70 for It may include a transceiver. More precisely, when charging a battery or an actuator using energy, feedback information related to the charging process is sent, and accordingly, the supply of energy is changed. When charging a battery or an actuator using energy, feedback information related to the charging process is sent and accordingly, the supply of energy is changed.

[0270] FIG. 24 shows an alternative embodiment in which the device 10 is adjusted from outside the patient's body. The system 28 has a movement-restricted device 10 connected to a battery 70 via a subcutaneous switch 80. Thus, the adjustment of the device 10 is performed non-invasively by manually pressing the subcutaneous switch, whereby the on and off of the operation of the device 10 is switched. It should be understood that the illustrated embodiment is simplified and that additional components such as an in-body control unit or any other part disclosed in the specification of the present invention may be added to this system. FIG. 24 shows an alternative embodiment in which the device 10 is adjusted from outside the patient's body. The system 28 has a movement-restricted device 10 connected to a battery 70 via a subcutaneous switch 80. Thus, the adjustment of the device 10 is performed non-invasively by manually pressing the subcutaneous switch, whereby the on and off of the operation of the device 10 is switched. It should be understood that the illustrated embodiment is simplified and that additional components such as an in-body control unit or any other part disclosed in the specification of the present invention may be added to this system. and accordingly, the supply of energy is changed. and accordingly, the supply of energy is changed. and accordingly, the supply of energy is changed. and accordingly, the supply of energy is changed. and accordingly, the supply of energy is changed.

[0271] FIG. 25 shows an alternative embodiment in which the system 28 has a movement-restricted device 10 fluidly connected to a hydraulic fluid reservoir 52. Non-invasive adjustment is performed by manually pressing a hydraulic reservoir connected to the device 10. FIG. 25 shows an alternative embodiment in which the system 28 has a movement-restricted device 10 fluidly connected to a hydraulic fluid reservoir 52. Non-invasive adjustment is performed by manually pressing a hydraulic reservoir connected to the device 10. Non-invasive adjustment is performed by manually pressing a hydraulic reservoir connected to the device 10.

[0272] Another embodiment of the system incorporated into the device according to the present invention has a feedback device that sends information from inside or outside the patient's body in order to provide feedback information regarding at least one functional parameter of the movement-restricted device or device or a physical parameter of the patient and thereby optimize the operation of the device. Another embodiment of the system incorporated into the device according to the present invention has a feedback device that sends information from inside or outside the patient's body in order to provide feedback information regarding at least one functional parameter of the movement-restricted device or device or a physical parameter of the patient and thereby optimize the operation of the device. Another embodiment of the system incorporated into the device according to the present invention has a feedback device that sends information from inside or outside the patient's body in order to provide feedback information regarding at least one functional parameter of the movement-restricted device or device or a physical parameter of the patient and thereby optimize the operation of the device. Another embodiment of the system incorporated into the device according to the present invention has a feedback device that sends information from inside or outside the patient's body in order to provide feedback information regarding at least one functional parameter of the movement-restricted device or device or a physical parameter of the patient and thereby optimize the operation of the device.

[0273] One suitable functional parameter of the device corresponds to the transfer of energy for charging an in-body energy source. One suitable functional parameter of the device corresponds to the transfer of energy for charging an in-body energy source.

[0274] In FIG. 26, the system 2 implanted in a patient in which the skin 36 thereof is shown by a vertical line A configuration for supplying an accurate amount of energy to 8 is schematically shown. The movement restriction de vice 10 is similarly located inside the patient and preferably located just below the skin 36 of the patient and is connected to the implanted energy conversion device 30. Generally speaking, the implanted energy conversion device 30 may be placed in the abdomen, chest wall, fascia (e.g., within the abdominal wall), subcutaneous, or any other suitable location. The implanted energy conversion device 30 is adapted to receive the wire less energy E transmitted from the extracorporeal energy source 34a provided within the extracorporeal energy transmission device 34 located outside the skin 36 of the patient in the vicinity of the implanted energy conversion device 30 received. As is well known in the art, the wireless energy E is generally transmitted by any suitable transcutaneous energy transfer (TET) device, such as a device including a primary coil disposed within the extracorporeal energy source 34a and an adjacent secondary coil disposed within the implanted energy conversion device 30

[0275] When a current is supplied through the primary coil, energy in the form of a voltage is induced within the secondary coil, and this energy can be used to operate the movement restriction device after accumulating the energy that enters an energy storage device or accumulator, such as a battery or capacitor However, the present invention is generally not limited to any particular energy transfer technology, TET device, or energy storage device ice and can be transmitted using. ​​​​Any type of wireless energy may be used.

[0276] The amount of energy received by the device inside the body can be compared with the amount of energy used by the device. It should be understood that the term "used by the device" includes the energy stored by the device. As described above, the amount of energy transmitted can be adjusted by an external control unit 34b that controls the external energy source 34a based on a predetermined energy balance. To transmit an exact amount of energy, the energy balance and the amount of energy required can be determined by an internal control unit 56 connected to the retrograde disease treatment device 10. Therefore, the internal control unit 56 may be configured to receive various measurement values obtained by appropriate sensors, that is, although not shown, by measuring certain characteristics of r10 and indicating in some way the amount of energy required to operate the device 10 properly. Further, the current state of the patient can also be sensed by an appropriate measuring device or sensor to provide parameters indicating the state of the patient. Therefore, these characteristics and / or parameters may relate to the current state of the device 10, such as power consumption, operating mode and temperature, and furthermore to the state of the patient indicated, for example, by body temperature, blood pressure, pulse and respiration. It should be understood that the term "used by the device" includes the energy stored by the device. As described above, the amount of energy transmitted can be adjusted by an external control unit 34b that controls the external energy source 34a based on a predetermined energy balance. To transmit an exact amount of energy, the energy balance and the amount of energy required can be determined by an internal control unit 56 connected to the retrograde disease treatment device 10. Therefore, the internal control unit 56 may be configured to receive various measurement values obtained by appropriate sensors, that is, although not shown, by measuring certain characteristics of r10 and indicating in some way the amount of energy required to operate the device 10 properly. To transmit an exact amount of energy, the energy balance and the amount of energy required can be determined by an internal control unit 56 connected to the retrograde disease treatment device 10. Therefore, the internal control unit 56 may be configured to receive various measurement values obtained by appropriate sensors, that is, although not shown, by measuring certain characteristics of r10 and indicating in some way the amount of energy required to operate the device 10 properly. Therefore, the internal control unit 56 may be configured to receive various measurement values obtained by appropriate sensors, that is, although not shown, by measuring certain characteristics of r10 and indicating in some way the amount of energy required to operate the device 10 properly. To transmit an exact amount of energy, the energy balance and the amount of energy required can be determined by an internal control unit 56 connected to the retrograde disease treatment device 10. Therefore, the internal control unit 56 may be configured to receive various measurement values obtained by appropriate sensors, that is, although not shown, by measuring certain characteristics of r10 and indicating in some way the amount of energy required to operate the device 10 properly. Furthermore, to provide parameters indicating the state of the patient, the current state of the patient can also be sensed by an appropriate measuring device or sensor. Therefore, the internal control unit 56 may be configured to receive various measurement values obtained by appropriate sensors, that is, although not shown, by measuring certain characteristics of r10 and indicating in some way the amount of energy required to operate the device 10 properly. Therefore, these characteristics and / or parameters may relate to the current state of the device 10, such as power consumption, operating mode and temperature, and furthermore to the state of the patient indicated, for example, by body temperature, blood pressure, pulse and respiration. Therefore, these characteristics and / or parameters may relate to the current state of the device 10, such as power consumption, operating mode and temperature, and furthermore to the state of the patient indicated, for example, by body temperature, blood pressure, pulse and respiration. Therefore, these characteristics and / or parameters may relate to the current state of the device 10, such as power consumption, operating mode and temperature, and furthermore to the state of the patient indicated, for example, by body temperature, blood pressure, pulse and respiration.

[0277] Furthermore, 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, again as required, Furthermore, 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. Furthermore, 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, again as required, The characteristics of such an accumulator indicating the amount of energy may also be measured. The accum ulator may be replaced by a battery, and the characteristics to be measured may be related to the current state of the battery, such as voltage and temperature. In order to provide sufficient voltage and current to the device 10 and further to prevent excessive heating, the battery should receive an appropriate amount of energy, neither too little nor too much, from the implanted energy conversion device 30 and be optimally charged. It should be understood that the accumulator may be a capacitor having corresponding characteristics.

[0278] For example, the characteristics of the battery may be measured periodically to determine the current state of the battery, and these may be stored in appropriate storage means within the internal control unit 56 as information regarding the state. Thus, when new measurement values are obtained, the stored information regarding the state of the battery may be updated accordingly. In this way, the state of the battery may be "calibrated" by transmitting an appropriate amount of energy, thereby

[0279] maintaining the battery in an optimal state. Therefore, the internal control unit 56 is adapted to determine the energy balance and / or the amount of energy currently required (energy per unit time or stored energy) based on the measurements obtained by the sensors or measurement devices mentioned above of the reverse flow disease treatment device 10 or the patient or the energy storage device or any combination thereof when used. The internal control unit 56 further connects a control signal indicating the It is connected to an in - vivo signal transmitter 82 configured to transmit to an in - vitro signal receiver 34c. In this case, in response to the received control signal, the amount of energy transmitted from the in - vitro energy source 34a can be adjusted.

[0280] Alternatively, the measured values of the sensors may be directly transmitted to the in - vitro control unit 34b. In this case, the energy balance and / or the amount of energy currently required may be determined by the in - vitro control unit 34b. Thus, the functions of the in - vivo control unit 56 described above are incorporated into the in - vitro control unit 34b. In this case, the in - vivo control unit 56 may be omitted, and the measured values of the sensors are directly supplied to the in - vivo signal transmitter 82, and the in - vivo signal transmitter 82 sends these measured values to the in - vitro signal receiver 34c and the in - vitro control unit 34b. Subsequently, based on these sensor measured values, the energy balance and the amount of energy currently required can be determined by the in - vitro control unit 34b.

[0281] Therefore, in this solution, it is adopted to feedback information indicating the required energy, which is more efficient than the conventional solutions. This is because it is based on, for example, the amount of energy, the difference in energy, or the received energy rate compared with the energy rate used by the device 10, etc., and is based on the actual usage amount of the received energy compared with the received energy. The device 10 may use the received energy for either consuming energy or accumulating it in an energy storage device or the like. Thus, the multiple parameters discussed above ​​​​​​​​​Meters are used as tools for determining the actual energy balance when they are relevant and required. However, these parameters are not necessarily required, especially for any internal operations performed internally to operate the device.

[0282] The in-body signal transmitter 82 and the out-of-body signal receiver 34c may be implemented as separate units using suitable signal transmission means such as radio waves, IR (infrared) or ultrasonic signals. Alternatively, the in-body signal transmitter 82 and the out-of-body signal receiver 34c may be integrated into the implanted energy conversion device 30 and the out-of-body energy source 34a, respectively.

[0283] In summary, the energy supply configuration shown in FIG. 26 operates basically in the following manner. First, the energy balance is determined by the in-body control unit 56. A control signal indicating the amount of energy required is further generated by the in-body control unit 56, and the control signal is transmitted from the in-body signal transmitter 82 to the out-of-body signal receiver 34c. Alternatively, the energy balance may be determined by the out-of-body control unit 34b instead of depending on the above-described instrument. In this case, the control It can be adjusted by unit 34b. This process can be intermittently repeated at specific intervals while continuing the energy transmission, or can be continuously executed to some extent when transmitting energy. It may be intermittently repeated at specific intervals while continuing the energy transmission, or may be continuously executed to some extent when transmitting energy. It can be adjusted by unit 34b. This process can be intermittently repeated at specific intervals while continuing the energy transmission, or can be continuously executed to some extent when transmitting energy.

[0284] The amount of energy transmitted can generally be adjusted by adjusting various transmission parameters of the external energy source 34a, such as voltage, current, amplitude, wave frequency, and pulse characteristics. The amount of energy transmitted can generally be adjusted by adjusting various transmission parameters of the external energy source 34a, such as voltage, current, amplitude, wave frequency, and pulse characteristics. It can be adjusted by unit 34b. T...

Claims

1. A transplantable medical device for treating retrograde diseases in a human patient, wherein the transplantable medical device comprises a movement restriction device ( 10) having an outer layer containing a biocompatible material, the movement restriction device is configured to be fully recessed into the wall of the fundus (16) of the patient's stomach, the movement restriction device comprises a body (13) configured to be stationary with respect to the wall of the fundus (16) of the patient at a position between the patient's diaphragm and the wall of the fundus (16) of the stomach, as a result, the cardiac incisure of the patient's stomach is configured to be restricted from moving towards the patient's diaphragm, whereby the cardiac orifice (14) is prevented from sliding through the patient's diaphragm that is open into the patient's thoracic cavity, the movement restriction device comprises non-penetrating holes disposed on the outer wall of the movement restriction device for holding the movement restriction device by a surgical instrument during transplantation of the movement restriction device, A transplantable medical device.

2. The transplantable medical device according to claim 1, wherein the non-penetrating holes comprise raised portions with depressions.

3. The transplantable medical device according to claim 1, wherein the transplantable medical device is adapted to pass through a trocar.

4. The transplantable medical device according to any one of claims 1 to 3, wherein the transplantable medical device is made of a uniform material.

5. The transplantable medical device according to any one of claims 1 to 4, wherein the transplantable medical device is filled with a fluid.

6. The transplantable medical device according to claim 5, wherein the fluid is a gel.

7. The transplantable medical device according to any one of claims 1 to 6, further comprising a fixing device for fixing the movement restriction device to the esophagus of the patient.

8. The transplantable medical device according to claim 7, wherein the fixing device comprises at least one suture.

9. The transplantable medical device according to any one of claims 1 to 4, 7, 8, wherein the movement restriction device comprises one core portion and at least one outer portion.

10. The transplantable medical device according to claim 9, wherein the core portion comprises at least one hole. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​

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