Device for curing gerd

Abstract

To provide an embeddable device for curing a backflow of a gastric acid or fatness which has a main body having an outer face constituted so as to abut on a stomach bottom wall of a patient, and fills a capacity in an abdominal part of the patient in a patient cardia region and above the cardia of the patient when the patient takes an erecting posture when the device is embedded into a body of the patient.SOLUTION: A main body prevents a cardia from intruding into a thoracic cavity through a diaphragm opening part, and thereby prevents a backflow by maintaining abdominal pressure for supporting a cardia sphincter. A device can be fixed to a gastric tissue. Also, the device can be infiltrated into a proper position, or indirectly fixed to a proper position by the other method. The device has a size of at least 125 mm3, and an external periphery of at least 15 mm.SELECTED DRAWING: Figure 1A

Description

[Technical field]

[0001] The present invention relates to a device for treating gastroesophageal reflux disease (GERD). [Background technology]

[0002] Gastroesophageal reflux disease (GERD), or acid reflux disease, is the result of the reflux of stomach acid into the esophagus. It is a chronic condition that repeatedly recurs and causes damage to the esophageal mucosa. This is due to temporary or permanent changes in the barrier between the esophagus and the stomach. is caused by insufficiency of the lower esophageal sphincter (LES), temporary relaxation of the LES, or impaired release of gastric juice from the esophagus. , or it may be due to a hiatal hernia.

[0003] GERD can be treated in many different ways. Treatments include, but are not limited to: However, both medical and surgical treatments are available. Standard treatments are sometimes preferred over the long-term use of drugs. The surgical treatment is a Nissen fundic plication procedure, which strengthens the sphincter muscle to prevent acid reflux. Then, the upper curve (fundus) of the stomach is wrapped around the LES to repair the hiatal hernia. The procedure is often performed laparoscopically.

[0004] Other surgical treatments that have been used include the insertion of a horseshoe-shaped device over the cardia. There is an Anglechik prosthesis that is placed around the esophagus of a patient. The intended effect is to prevent the cardia from The aim of the device is to prevent it from entering the thoracic cavity. This is associated with many complications, including esophageal cancer and damage to the esophagus.

[0005] Experience with medical device implantation has shown that sutures between the implanted device and human tissue are not known to last for long periods of time. For long-term implantation of the device, There are two possible solutions to hold it in place. The first solution is to suture human tissue to human tissue and then This holds the device in place. The second approach is to The device is then fitted with sutures to hold the device in place and allow human tissue to grow into it. The device was designed to hold the device in place for an extended period of time.

[0006] One challenge in creating an implantable device that is related to the esophagus is the external surface of the esophagus. The main reasons for this include that the esophageal mucosa is composed only of esophageal muscle tissue and is highly susceptible to injury or mobility. This is probably why many of the problems with the Anglechik prosthesis mentioned above, such as its resulting migration, occur. This is one reason that complications may occur.

[0007] On the other hand, the stomach has a serous membrane on its outside, which makes it quite resistant to sutures. Therefore, suturing the device directly to the stomach wall would prevent the implanted device from reaching the esophagus. This provides better results than suturing.

[0008] Today, it is more effective than conventional treatments and does not result in serious complications. There is a need for long-term treatment for GERD that does not cause GERD. Summary of the Invention [Problem to be solved by the invention]

[0009] One object of the present invention is to address some of the problems associated with existing surgical treatments for gastroesophageal reflux disease (GERD). The goal of the study is to overcome or at least mitigate some of the problems.

[0010] Another object of the present invention is to provide a device for treating gastroesophageal reflux disease.

[0011] These and other objects are achieved by the device as set forth in the appended claims. Thus, an implantable endothelial cell having an outer surface comprising a biocompatible material is provided. The present invention provides an apparatus for treating acid reflux disease, the apparatus comprising a restriction device, the apparatus comprising: and placing at least a portion of the outer surface against the patient's gastric fundus wall at a location between the gastric fundus wall and the patient's gastric fundus wall. The movement restriction device is configured to restrict movement of the cardiac notch of the patient's stomach toward the patient's diaphragm. By restricting the flow of blood to the blood vessels, a device for treating reflux disease is obtained. The device must be at least 125 mm 3 Size and circumference of at least 15 mm and restricts the cardiac notch of the patient's stomach from moving toward the patient's diaphragm, thereby preventing esophageal Prevents the gate from sliding through the patient's diaphragmatic opening into the patient's thoracic cavity The fixation device maintains supportive pressure exerted by the patient's abdomen against the cardiac sphincter of the anus. The movement restriction device is configured to fix the movement restriction device in the position.

[0012] Because the gastric fundus is more sensitive than the esophagus, the outer surface of the implanted mobility restriction device should be placed against the gastric fundus wall. By configuring the device to abut against the skin, the risk of complications such as transfer of damage to tissue is minimized. can be kept to a small limit. [Means for solving the problem]

[0013] In a first embodiment of the invention, the fixing device fixes the movement restriction device in said position. Sutures or stays are used to connect the portion of the fundus wall surrounding the migration restriction device to That is, the movement restriction device is designed to at least partially Thus, implantable movement restriction devices can be indirectly implanted in this manner. By fixing the movement restriction device to the tissue, suturing between the movement restriction device and the tissue is unnecessary, and thus , further reducing the risk of complications. As a result of holding the movement restriction device in place in this manner, , an elastic support with improved long-term properties was obtained.

[0014] A fixation device, such as a suture or stapler, attaches the migration restriction device to the inside of the patient's stomach wall. or joining portions of the fundus wall together so as to substantially or completely invaginate them from the outside. When the migration restriction device is placed on the outside of the patient's stomach wall, the migration restriction device such that the stomach cavity is substantially reduced in volume by substantially more than the volume of the migration restriction device. It is invaginated by the fundus wall.

[0015] In a second embodiment of the invention, the fixation device is adapted to fix the movement restriction device in said position to the stomach. A recessable first fixing device attached to the bottom wall, indirectly or directly, to restrict movement A second fixation device that fixes the limited device to the esophagus near the angle of His in the patient, and an indirect fixation device. and fastening the movement restriction device to the patient's diaphragm muscle or associated muscles, either directly or indirectly. and a third fixation device. Any of the first, second, and third fixation devices may be The first fixation device may be a movement limiting device. The device can be provided with a tissue growth promoting structure to keep the device attached to the stomach wall for a long period of time. The long promotion structure can be sutured to the stomach wall with a relatively large contact surface facing the stomach. A relatively large surface area of ​​netting or other structure can help keep mobility restriction devices in place for extended periods of time. The tissue growth promoting structure can be used to promote the growth of human tissue to hold the tissue in place. The catheter may include sutures or staples to attach the catheter-like structure to the fundus wall.

[0016] In addition to embedding a movement restriction device according to the first embodiment of the present invention, a second fixation The fixed device indirectly or directly inserts the mobility restriction device into the esophagus near the patient's angle of His. and a third fixation device may be used to fix the Generally, it is used to secure a movement restriction device to the patient's diaphragm muscle or related muscles. It is possible.

[0017] At least a portion of the mobility restriction device is destructible or destructible by stomach acid. It can be made from materials that are not

[0018] The movement restriction device is expandable and configured to expand with a gel or fluid. A fluid or gel reservoir for containing a fluid to inflate the movement restriction device. The material may be provided.

[0019] The movement restriction device may comprise a homogenous material and may be a solid body.

[0020] The movement restriction device may include an enclosure wall defining a chamber.

[0021] The movement restriction device can have a rigid, elastic, or flexible outer wall. If the outer wall is rigid, it will remain undeformed even when subjected to forces generated by stomach motility. The first embodiment described above has sufficient rigidity. The migration restriction device is preferably at least partially invaginated by the patient's fundus wall. The present invention relates to a method for treating a vascular endothelial cell, the method comprising: The target portion abuts against the stomach wall at the position between the patient's diaphragm and the lower portion of the invaginated stomach fundus wall. Optionally, the body is made of a material having a Shore hardness of 25 or softer than 15. can be done.

[0022] According to a first overall design of the body, the body has a diameter, when viewed in a plane perpendicular to an axis passing through the body, The circumference of the body as viewed in another plane perpendicular to said axis is the maximum circumference The circumference is equal to or decreases along said axis in a direction from the maximum circumference. For example, the body may be substantially ovoid, spherical, substantially egg-like in shape with an intended central portion, or may be shaped like a curved egg.

[0023] According to a second overall design of the body, the exterior of the body as viewed in a plane perpendicular to an axis passing through the body is the perimeter increases or decreases by at least a factor of two when the plane is displaced along said axis, or The thickness of the body decreases and increases by at least a factor of 1 when the plane is displaced along the axis. It may be shaped substantially like a kidney.

[0024] Preferably, the body is dimensioned to be larger than the intestinal outlet from the stomach. They can have a minimum outer diameter of 30 or 40 mm or more, and can also be 150, 110, 90, 7 It may have a minimum circumference of 0, 50, or 30 mm.

[0025] Optionally, the body has a rounded contour without sharp edges that could injure the patient's stomach wall, and It has a generally smooth outer surface for resting against the bottom wall.

[0026] The body can be implanted inside or outside the patient's stomach and surgically inserted into the patient's stomach. The body is configured to be attached to a wall. The body is configured to be attached to a trocar for use in laparoscopy. the diameter of the slit is smaller than that of the slit, so that the slit can be modified to assume a slender form having a diameter smaller than that of the slit. When the body is transformed into the slender configuration, it can be pushed or pulled through a trocar. The body may include a flexible outer wall defining a chamber that is filled with a fluid, such as a gel. , so that the body can be passed through such a trocar. The may be constructed of a resilient compressible material, which allows the body to be passed through a trocar. can.

[0027] The body may be hollow and may be adapted to be inserted into such a hollow body and At least two pieces that are joined together to form one integral piece inside the body A separate piece may be provided to connect the body to a trocar for use in laparoscopy. Alternatively, the body can be filled with a fluid or gel after insertion into the patient. It may have an outer wall and a hollow compressed interior for filling.

[0028] The body may include a chamber having an inlet through which the fluid is introduced into the chamber. It is filled.

[0029] The body is used to push or pull the body through a trocar for laparoscopy. The device may include at least one holding device configured to hold the device in place. The surgical instrument is configured to hold an extension of the body that is configured to be held by the surgical instrument. More specifically, the retention device may include a suture or thread inserted through the retention device. The retaining device is configured to retain the band. When the body includes an outer wall, the retaining device may include at least The catheter is at least partially disposed inside the outer wall of the body.

[0030] In one advantageous embodiment, the body is adjustable in size and is adapted to be invaginated within the patient's fundus wall. As a result, the body stretches the patient's fundus wall as it increases in size. This also makes patients who suffer from obesity feel full. at least two implantable adjustable enlargement devices for Obesity can be treated by effectively influencing the patient's appetite. The stretching device is appropriately adjusted from outside the patient's body, thereby forming a first stretching device. The vice is first adjusted to stretch a first portion of the patient's stomach wall and then adjusted to stretch a second portion of the stomach wall. The device is adjusted a second time to stretch a second portion of the patient's stomach wall.

[0031] The stretching device may also be hydraulically adjusted. In this case, a hydraulically adjusted stretching device is called and a subcutaneously implantable hydraulic reservoir connected to the device, thereby providing a hydraulically adjustable draw. The stretching device is non-invasively adjusted by manually applying pressure to the hydraulic reservoir. The movement restriction device optionally comprises an inflatable body and is in fluid contact with the pump and the body. The pump generates hydraulic pressure by pumping fluid or air from the body into the chamber. Adjust the tank.

[0032] The device delivers stimulation pulses to the cardiac muscle to stimulate the cardiac muscle, thereby further closing the cardiac muscle. The device may include an implantable stimulation device that provides additional protection against reflux disease. The device receives at least one conductor and a stimulation pulse and applies the same to the cardiac muscle; and at least one electrode by which the cardiac muscle is stimulated. The electrodes may also be held in place by gastroesophageal sutures or invaginations within the stomach wall. The signal can be sent as a train of pulses with time breaks between them. The stimulation is repeated with an increased break between each pulse in the train. The device is a device that includes an electronic circuit and an energy source, preferably integrated together. In one embodiment, the stimulation of the cardia by the stimulation device comprises: This is done using energy pulses to increase sphincter tone and completely close the cardia. A control device for controlling the stimulation device is operated by the patient to operate the stimulation device. In the operative state, the stimulation device is operable to stimulate the cardiac sphincter to receive said energy. The patient was able to switch between the operating mode, where the esophagus was stimulated by the gastric pulse, and the resting mode, where the esophagus was not stimulated. It operates alternately continuously when not lowering.

[0033] The stimulation device preferably detects the physical parameters of the patient or the functional parameters of the movement restriction device. at least one sensor for sensing a parameter, and a stimulation device for controlling the stimulation device; The internal control unit is

[0034] Typically, an internal control unit controls the stimulation device in response to information from the sensors.

[0035] A sensor that senses esophageal contraction waves, or any other parameter that correlates with food intake, The internal control unit then calculates such information from the sensors. The stimulation is stopped in response to the necessary information.

[0036] The stimulation device can be controlled by the patient at any time.

[0037] The present invention further relates to abdominal surgical procedures for treating reflux disease.

[0038] According to the first method, the reflux disease of the patient is ameliorated by the diaphragm muscle when implanted in the patient. The gastric notch is restricted from moving upwards and the cardia is prevented from sliding upwards through the diaphragmatic hiatus opening. This method involves inserting a needle or tubular instrument into the inserting a needle or tubular device into the abdominal portion of the patient's body; and placing at least two laparoscopic trocars in the patient's body. and inserting the camera through one of the laparoscopic trocars into the patient's abdomen; Passing at least one cutting tool through one of the at least two laparoscopic trocars. The method includes the steps of inserting the device into the abdominal cavity, incising an area of ​​the stomach, and introducing the device into the abdominal cavity. placing the device on the outside of the fundus wall; and creating a pouch within the fundus wall for the device. forming a stent in the stomach and applying sutures or staples to the fundus wall to form the device. This allows the cardia to slide out and enter the patient's thoracic cavity through the patient's diaphragmatic opening. and maintain pressure support from the patient's abdomen supporting the patient's cardiac sphincter. This includes the

[0039] The second abdominal treatment, which treats reflux disease for the same purpose as the first, involves the initial step of The procedure involves creating a hole in the fundus wall and introducing a migration restriction device into the abdominal cavity. and inserting the device through the hole into the stomach. The device is placed on the inside of the fundus wall. forming a pouch outside the gastric cavity for a device that is placed inside the fundus wall; The device is then invaginated into the pouch by applying sutures or staples to the fundus wall, and the device is then injected into the pouch. Prevents the gate from sliding through the patient's diaphragmatic opening into the patient's thoracic cavity and prevents the patient's cardiac sphincter and maintaining support pressure from the patient's abdomen supporting the patient.

[0040] A third abdominal method for treating reflux disease in a patient has the same objectives as the previously disclosed methods. The method includes implanting a movement restriction device to surgically open the patient's abdominal wall. forming an ostium, incising a region of the patient's stomach, and a movement restriction device through the abdominal incision; and attaching the device to the fundus wall, thereby Prevents the cardia from sliding through the patient's diaphragmatic opening into the patient's thoracic cavity and prevents the patient's cardiac sphincter and maintaining support pressure from the patient's abdomen supporting the muscle. According to the method, the device is placed outside the fundus wall of the stomach and a pouch is provided within the fundus wall for the device. and attaching the device to the fundus wall by applying sutures or staples. The pouch collapses, causing the cardia to slide out and enter the patient's thoracic cavity through the patient's diaphragmatic opening. and maintaining supportive pressure from the patient's abdomen supporting the patient's cardiac sphincter. According to a second alternative, the method includes forming a hole in the fundus wall and restricting migration. The device is inserted through the hole and introduced into the stomach, the device is placed inside the fundus wall, and the device is inserted into the stomach. forming a pouch in the fundus wall for the device and applying sutures or staples to the fundus wall; The device is then invaginated into the pouch, and the cardia slides out and enters the patient's chest through the patient's diaphragmatic opening. Maintaining supportive pressure from the patient's abdomen to prevent entry into the cavity and support the patient's cardiac sphincter This includes the following.

[0041] The method involves securing the device to the fundus wall by applying sutures or staples. and / or applying sutures or staples to secure the fundus wall to the patient's esophagus. Fixation to the lower portion and / or fixation of the fundus wall to the patient's diaphragm or associated muscles The method further includes adjusting the reflux treatment device from outside the patient's body. and further comprising: providing an apparatus and operating the apparatus to regulate a reflux treatment device. The adjustment of the reflux treatment device may include changing the volume of the filler when implanted. To this end, these methods include a jet-type syringe containing a fluid to be injected into the filling body; and injecting the device into the pouch. Preferably, these methods include sealing the device in a pouch. In one embodiment, the method includes leaving the bag at least partially open; This results in either a pouch showing only one opening or a pouch showing two openings and a non-circumferential opening around the stomach. Generally, it is preferred that the volume of the bag is greater than 15 milliliters. It is nice.

[0042] Other laparoscopic abdominal procedures to treat reflux disease involve inserting a needle or tubular instrument into the patient's body. A needle or tubular device is inserted into the abdomen of the body and used to fill the patient's abdomen with gas placing at least two laparoscopic trocars in the patient's body; inserting a smear into the patient's abdomen through one of the laparoscopic trocars; inserting a cutting tool through one of the at least two laparoscopic trocars; incising an area of ​​the stomach and forming a pouch from the fundus wall for the device; and suturing the pouch. Closing the bag by applying a suture and staples and filling the bag with the injectable filling material. and injecting a filling material into the bag, whereby when the patient is in an upright position, forming a filler body that fills a volume within the patient's abdomen adjacent and overlying the patient's cardia; Prevents the cardia from sliding through the patient's diaphragmatic opening into the patient's thoracic cavity and prevents the patient's cardiac sphincter and maintaining pressure within the patient's abdomen to support the muscles.

[0043] Other surgical abdominal procedures to treat reflux disease involve incisions into the patient's abdomen. forming an opening and incising a region of the stomach; and forming a pouch from the fundus wall for the device; and closing the bag by applying sutures and staples and applying an injectable fill material. and injecting a filling material into the bag, thereby allowing the patient to stand upright. forming a filler body that, when inserted, fills the volume within the patient's abdomen adjacent to and overlying the patient's cardia. and prevents the cardia from sliding through the patient's diaphragmatic opening and into the patient's thoracic cavity, and maintaining pressure within the patient's abdomen supporting the sphincter.

[0044] Another method described is to form a pouch on the outside of the fundus wall and have the filling material contact the inside of the fundus wall. Alternatively, these methods may include placing a hole in the fundus wall. wherein the pouch is formed on the inside of the fundus wall and the filling body abuts on the outside of the fundus wall. Other methods described preferably use sutures or staples. and / or to fix the fundus wall to the lower part of the patient's esophagus by applying a The bag is generally designed to be fixed to the diaphragm or associated muscles of the patient. Preferably, the volume is greater than 5 milliliters. The fill material is preferably a semi-solid material, preferably a fluid material. or can undergo a hardening process into a solid material. Preferably, it is induced by a temperature increase from ambient temperature to body temperature. Preferred such materials undergo crosslinking reactions under the influence of heat (in the presence of a crosslinking agent and a catalyst). It is a thermosetting polysiloxane that can undergo reaction.

[0045] When implanted in a patient, it limits the movement of the gastric notch relative to the diaphragm muscle and allows the cardia to slide upward. By implanting a mobility restriction device that prevents the diaphragm from escaping through the diaphragmatic hiatus opening, Yet another laparoscopic abdominal procedure for treating reflux disease involves inserting a needle or tubular instrument into the patient. and inserting a needle or tubular device into the patient's abdomen. and placing at least two laparoscopic trocars in the patient. and inserting the camera through one of the laparoscopic trocars into the patient's abdomen. and at least one incision tool is inserted between at least two laparoscopic trocars. The method includes the steps of inserting the catheter through one of the catheters, incising an area of ​​the stomach, and forming a hole in the fundus wall. and introducing a movement restriction device into the abdominal cavity. and introducing the device into the stomach; placing the device on the outside of the fundus wall of the stomach; and fixing the device to the patient's side and preventing the cardia from sliding out and passing through the patient's diaphragmatic opening. Support pressure from the patient's abdomen that prevents the blood from entering the patient's thoracic cavity and supports the patient's cardiac sphincter and maintaining the wound by applying a suture or stapler. The step may further include anchoring the device to the fundus wall.

[0046] The present invention is suitable for use with any of the aforementioned laparoscopic methods to detect reflux disease. Abstract: A peritoneal cavity for providing a migration restriction device to be invaginated into the gastric fundus wall of a human patient to treat The term also refers to laparoscopic instruments, which generally refer to instruments introduced into the patient's abdomen during laparoscopic surgery. a proximal end and a distal end having a diameter smaller than the diameter of the laparoscopic trocar to be inserted; and a pushing device for pushing the fundus wall into the gastric cavity. and forming a tube-shaped portion protruding from the tube-shaped portion. and a pushing device including a movement restriction device to be invaginated into the stomach. The device includes a laparoscopic instrument that works together to form a tube-shaped portion of the fundus wall. The device also includes a vacuum suction device for suctioning the fundus of the stomach to assist in the suction of the abdominal cavity. a vacuum passageway extending from the proximal end to the distal end of the laparoscopic instrument at the end of the laparoscopic instrument; At its end is a pushing device. The vacuum passageway extends from the stomach wall portion to the pushing device. and dividing the gastric tissue into a plurality of small openings configured to further form a tubular stomach wall portion. The laparoscopic instrument is adapted to introduce the movement restriction device into the tubular shaped stomach portion. The laparoscopic instrument further comprises an insertion device configured to insert an intergastric clamp within the opening. at least one for holding the opening of the tubular portion substantially closed by The laparoscopic instrument may further include a fastening device for laterally closing the opening. At least one fastening device is placed at the opening in a manner that allows for suturing. The laparoscopic instrument is configured to inflate the movement restriction device before or after suturing. The laparoscopic instrument may further include an expansion device surrounding the movement restriction device. The tubular portion is opened with an intergastric suture to form an at least partially closed space. The laparoscope may further include a suturing device configured to suture the mouth. The device is adapted to be withdrawn leaving the migration restriction device at least partially invaginated within the fundus wall. The suturing device is configured to be attached to an elongated member that is positioned at its distal end within the stomach. The laparoscopic instrument may include first and second suture positioning members disposed on the suture holder. a first and second suture positioning member with the stomach wall on either side of the open end of the cup-shaped portion; and configured to adjust the first and second suturing members in a position in front of each other; The operation device is configured to suture the open end of the cup-shaped portion of the fundus wall with a row of intergastric sutures. The suturing device preferably further comprises a suture retractor for retracting the suture from outside the patient's body. and a suture for suturing the open end of the cup-shaped portion of the fundus wall with said row of intergastric sutures. a steerable, reloadable, multi-suturing device configured to: Suturing devices include two or more sutures or staplers that are sometimes stitched together. Multiple sutures may be provided for suturing two or more sutures simultaneously. .

[0047] The present invention, when implanted in a patient, limits the movement of the gastric notch relative to the diaphragm muscle and reduces the risk of cardia an implantable movement limiting device that prevents the diaphragm from sliding upward and through the diaphragmatic hiatus opening The present invention also relates to an intraluminal method of treating reflux disease in a patient by implanting a device. The method includes the steps of introducing a gastroscope into the patient's esophagus and into the stomach, and a gastroscope for inserting an instrument into the patient's esophagus and into the stomach, the instrument being either integrated into the gastroscope or separate from the gastroscope. and using the instrument to introduce the device into the fundus wall of the stomach to accommodate the device. forming a pouch and fastening the device within the pouch by applying sutures or staples to the fundus wall. This prevents the cardia from sliding out and entering the patient's thoracic cavity through the diaphragmatic opening. and maintaining supportive pressure against the patient's cardiac sphincter exerted from the patient's abdomen. In a first alternative, the method includes a step of introducing the device into the stomach using an instrument. and using said instrument to place a device inside the fundus wall. The device is placed against the inside of the fundus wall of the stomach, and the device is used to insert the device into a part of the fundus wall outside the gastric cavity. forming a pouch and applying sutures or staples to the fundus wall to secure the device within the pouch. In a second alternative, the method includes using the instrument to: forming a pouch in a portion of the fundus wall and introducing a device into the pouch using an instrument. and applying sutures or staples to the fundus wall to invaginate the device. According to this alternative, the method preferably includes injecting a fill fluid into the device. The device is expanded to its fill volume by allowing the fill volume to be obtained. Thus, the fill fluid may be any of the previously mentioned thermosetting polysiloxanes. According to a third alternative, the hardenable fluid may have the properties described in The method includes the steps of forming a hole in the fundus wall and introducing a device into the stomach with an instrument. and threading the device through the hole to place the device on the outside of the fundus wall. The device is placed against the outside of the gastric fundus wall, and the gastric cavity is then penetrated by the device. forming a pouch in a portion of the fundus wall; and applying sutures or staples to the fundus wall to form the pouch. and sealing the hole with a suture or stapler. According to a fourth alternative, the method includes the steps of forming a hole in the fundus wall; forming a pouch in a portion of the fundus wall inside the gastric cavity using the instrument; Introducing the device into the stomach and threading the device through the hole to attach the device to the fundus wall of the stomach. the steps of placing the device on the outside of the pouch, introducing the device into the pouch using an instrument, and attaching the suture. or applying a stapler to the fundus wall to invaginate the device; and applying a suture or staple to the fundus wall. and sealing the hole with a stapler. The method also preferably includes dispensing the filler fluid into the device. The device is then injected into the device to obtain a fill volume. The fill fluid may include expanding the fill fluid to a volume having all of the above characteristics. The method includes applying a suture or stapler to secure the device. by fixing to the fundus wall and / or by applying sutures or staples Fixing the fundus wall to the lower part of the patient's esophagus and / or fixing the fundus wall to the patient's diaphragm muscle or The method includes adjusting the reflux treatment device from outside the patient's body. and operating the apparatus to regulate the reflux treatment device. The regulation of the reflux treatment device preferably includes, when implanted, To this end, the method includes changing the volume of the embedded filler. a jet-type syringe containing a fluid to be injected into the filling body; The fill fluid may include a filler fluid having properties as described in the previous paragraph. The bag formed in this manner may be a hardenable fluid having a movement restriction device. It may be enclosed or at least partially open, in one example being open. In some cases, it has only one mouth, while in others, it has two openings and extends non-circumferentially around the stomach Preferably, the volume of the bag is greater than 15 milliliters. Preferably, the speculum and the instrument are integrated. This method involves distending the stomach with gas. In one particular embodiment of the method, a pouch is formed from the fundus wall. Sometimes the device creates a vacuum.

[0048] The present invention also relates to a method for restoring the alignment of the cardia and fundus in a patient suffering from reflux disease. This involves introducing an elongated instrument having at least one flexible portion into the patient's esophagus. and activating a holding device with an instrument, the activated holding device being held by the instrument. Having a larger cross-sectional area and retaining the distal esophagus or stomach with the retention device. By moving the instrument distally and pushing it, the cardia, which was incorrectly positioned above the diaphragm, was removed. and sliding a portion of the stomach wall or fundus to a suitable location below the diaphragm or associated muscles. In a first alternative, the method includes replacing the retention device in the esophagus. and radially expanding the cardia and the stomach wall or involves pushing a portion of the fundus under the diaphragm or its associated muscles. In one embodiment, the method includes releasing a balloon member at a proximal end of the device within the lower portion of the stomach. and using this member, the cardia and the fundus of the stomach or a part of the fundus of the stomach are connected to the diaphragm or its related parts. and pressing the device against a portion of the lower wall of the stomach so that it slides beneath the associated muscle. In an alternative embodiment, the method further comprises inserting a distal end of the instrument at the level of the diaphragm or associated muscles. and placing the member in a wall of the stomach. , the cardia and part of the stomach wall or fundus slide under the diaphragm or its associated muscles and pushing the instrument distally so as to The device uses sutures or staples or other invasive mechanisms to secure the esophageal and stomach walls to the device. The distal portion of the instrument may include a mechanical member. Preferably, the method includes using a catheter below the esophagus above the cardia. A distal portion of the device may include a suture or stapler for suturing the fundus wall to the distal portion. The method includes using a suture member in minutes.

[0049] The present invention is also directed to a surgical gastroscopic instrument for treating a patient suffering from a hiatal hernia. In this case, a portion of the patient's stomach is placed in the thoracic cavity above the diaphragm muscle. The device is an elongated member having (i) a proximal end and a distal end. The elongated member has a diameter smaller than the diameter of the patient's esophagus and is flexible, thereby This allows the flexible, elongated member to be introduced, with its distal end leading, through the throat and into the esophagus. (ii) a retention device secured to the elongated member and adapted to be inserted into the patient's esophagus. and a retention device configured to engage and retain the esophagus or stomach. and operable between an inactivated state, wherein the retention device is configured to be released from the stomach. and (iii) a holding device for switching between the activated and deactivated states from outside the patient's body. (iv) an operating device for operating the holding device to switch the elongated member; A proximal end of the ... elongated member is connected to the proximal end of the elongated member so that the proximal end can be manually held in place for distal movement. and a handle that is attached to the gripping device and that is operated by the operating device in its activated state. When moved, the elongated member, when manually moved, moves the cardia distally and back against the diaphragm. to engage and hold the esophagus or stomach with enough strength to allow reintroduction into the appropriate submuscular position The manipulable holding device of the instrument is preferably configured to hold the elongated member in a position substantially parallel to the longitudinal axis of the instrument. The retaining device extends radially from a non-activated state to the activated state, the retaining device extending radially When expanded, it is configured to engage and retain the stomach or esophagus through force and friction. Alternatively, the operable holding device may be configured to hold the food when the holding device is in its activated state. The device is adapted to be invasively introduced into the wall of the stomach or esophagus to secure the retention device in the esophagus or stomach. In both alternatives, the at least one introducing member is configured to be operable. The retaining device is adapted to engage and retain the esophagus proximal to or at the cardia, It engages and holds the stomach at or distal to the hiatus when the cardia is above the diaphragm muscle. According to another alternative, the retention device is adapted to retain the esophagus or stomach. a first suture positioning member that is disposed within the esophagus when in a neutrophilic state; and an elongated member and a second suture positioning member at the distal end of the suture positioning member. The flexible elongated member is bent around the stomach so that the fundus wall and the esophageal wall are in position with the first and second sutures. A first suture positioning member is located above the cardia and is moved together with the first and and the second suture positioning member are configured to be positioned in front of each other. The reloading procedure involves suturing the patient's esophagus proximal to the cardia together with the gastric fundus wall with a single row of sutures. The gastric fundus wall and the esophageal wall are sutured at first and second suture positions. The sutures are moved together by a positioning member and the row of sutures is simultaneously sewn together by a multiple suturing device. It includes two or more sutures sewn together.

[0050] The present invention relates to a surgical gastroscopic instrument for treating a human patient suffering from a hiatal hernia. Other embodiments include: (i) an elongate member having a proximal end and a distal end; the elongated member has a diameter smaller than a diameter of the patient's esophagus and is flexible; The flexible, elongated member is then introduced, with its distal end at the forefront, down the patient's throat and into the esophagus. and (ii) a distal end of the elongated member that is disposed within the stomach. on the elongated member so as to be positioned within the esophagus proximal to the cardia when the member is introduced into the esophagus. (iii) a first suture positioning member disposed on the elongate member at a distal end thereof; (iv) a second suture positioning member disposed around the gastric notch; and The suture positioning members are bent so that the fundus wall and the esophageal wall are moved together by the first and second suture positioning members. The suture positioning members are configured to be moved in a position such that the first and second suture positioning members are in front of each other. (v) isolating the patient's esophagus proximal to the cardia with a row of sutures to the stomach. and a reloadable multiple suturing device for suturing together the fundus wall and the esophageal wall. are moved together by the first and second suture positioning members, and the multiple suture device The sutures are reinserted from outside the body to place additional rows of sutures before and after the first row of sutures. The row of sutures may be inserted into two separate sutures that may be simultaneously sutured by a multiple suture device. The instrument further comprises a retention device secured to the elongated member. The retention device is configured to engage and retain the esophagus or stomach of a patient. The retention device is configured to be activated and released from the esophagus or stomach. The retention device is operable between an activated and inactivated state from outside the patient's body. a manipulation device for switching between an activated state and a deactivated state, and a manipulation device for moving the elongated member distally. and a handle connected at its proximal end to the elongated member so that it can be held by hand. and the holding device is actuated by the operating device in the activated state. When the elongated member is moved manually, it moves the cardia distally and back under the diaphragm muscle. The catheter is configured to engage and retain the esophagus or stomach with sufficient strength to allow the catheter to be reintroduced into the appropriate location in the esophagus or stomach. In one embodiment, the manipulable holding device is configured to hold the deactivating member relative to the elongated member. and a holding device configured to hold the holding device in a radially expanded state from the activated state to the radially expanded state. The device is configured to engage and retain the stomach or esophagus with force and friction when the device is in use. In this embodiment, the steerable retention device is configured to retain the esophagus or The device is configured to be invasively introduced into the wall of the stomach or esophagus to secure the retention device to the stomach. In both alternatives, the at least one introduction member is provided with an operable holding device. The vice is adapted to engage and hold the esophagus proximal to or at the cardia, or When the hilum is above the diaphragm muscle, it engages and holds the stomach at or distal to the hiatus. It is configured as follows.

[0051] The present invention provides a migration restriction device to be invaginated into the gastric fundus wall of a human patient to treat reflux disease. Further, yet another embodiment of a surgical gastroscopic instrument for providing a gastrointestinal tract is provided. i) an elongate member having a proximal end and a distal end, the elongate member being sized to fit a diameter of the patient's esophagus; The flexible elongated member has a smallest diameter and is flexible such that its distal end is The device can be adapted to pass through the patient's throat, esophagus, stomach, and into the fundus wall of the stomach. (ii) a hole extending through the fundus wall of the stomach so that the elongated member can be introduced therethrough; A steerable stomach piercing device is provided at its distal end for forming a hole in the fundus wall. and (iii) an elongated member that penetrates the stomach wall when the elongated member penetrates the stomach wall. A through hole extends through the bottom wall and holds the proximal end of the needle in a position that prevents the proximal end from advancing through the hole. a proximal elongate member of the communication device, the proximal elongate member being substantially perpendicular to the elongate member and at least The gastric fundus wall is radially expandable and has an expandable member that abuts the gastric fundus wall on its outer side. and (iv) a migration restriction device for invaginating the fundus wall. and an insertion device for inserting into and out of the hole in the wall. A forming device is provided on the proximal elongated member of the special holding device so as to abut on the side. The forming device, in conjunction with a special retention device, cups the fundus wall. The special holding device is configured to form the shaped shape of the forming device. and retractable to draw the stomach wall against the forming device to form the cup-shaped stomach. The device sutures the open ends of the cup-shaped portion of the fundus wall with intergastric sutures, and the fundus wall is a suture configured to form a space at least partially surrounded by a portion of the The suturing device may further comprise a suturing device. The suturing device preferably comprises two or more The suturing device includes a plurality of sutures for simultaneously suturing the sutures on the anterior portion of the anterior cruciate ligament. The cup-shaped portion of the fundus wall before the vise is inserted through the hole in the fundus wall by the insertion device. The instrument is adapted to be passed through a hole in the fundus wall by an insertion device. The migration restriction device may be inflated after the catheter is introduced or introduced through a hole in the fundus wall. and an inflation device for inflating the movement restriction device after being introduced by the movement restriction device. The suturing device may further comprise a suture retractor. The apparatus is configured to suture the open end of the cup-shaped portion of the fundus wall with a row of intergastric sutures. The device may include an operable reloadable multiple suturing device configured to suturing a row of stitches. A doubling involves two or more sutures or staples being sewn together at the same time. In one embodiment, the apparatus includes an inflatable migration restriction device and a penetration device for penetrating the fundus wall. and adapted to be introduced through and delivered at least to or passed through the abdominal wall. The wire is inserted through the hole in the fundus wall of the stomach by the insertion device. When the device is inserted into the inflatable movement restriction device, the device is connected to the inflatable movement restriction device. The device can be connected to a subcutaneous injection port to fill and regulate the amount of fluid in the device. The hydraulic tubing is supported by a pair of ribs 14 and 16. The ribs 14 and 16 act as guides for the hydraulic tubing.

[0052] The present invention relates to an inflatable transport catheter to be invaginated into the gastric fundus wall of a human patient to treat reflux disease. Further provided is yet another embodiment of a surgical gastroscopic instrument for including a restriction device. The instrument includes (i) an elongate member having a proximal end and a distal end, the elongate member being inserted into the patient's esophagus. the flexible elongated member has a diameter smaller than the diameter of the distal end of the flexible elongated member and is flexible such that the flexible elongated member can move The catheter is inserted into the patient's throat, esophagus, stomach, and into the gastric fundus wall. and (ii) a hole in the fundus wall that allows the elongated member to be introduced through the hole. An operation in which an elongated member is provided at its distal end for penetrating and forming a hole in the fundus wall. and a gastric penetration device adapted to be introduced through a hole in the fundus wall, the penetration device comprising at least The abdominal wall may also include a wire that is fed to or threaded through the abdominal wall, the wire being an expandable A device connected to the movement restriction device, filling the inflatable movement restriction device with a fluid and a quantity of the fluid. It can be connected to a subcutaneously placed injection port to adjust the pressure of the fluid. The wire and / or tube are pulled to displace the fluid-inflated The migration restriction device is moved toward the fundus wall and placed inside the fundus wall, where the migration restriction device The device can be inserted into the fundus wall. At least one of the two is pulled to move the inflated migration restriction device toward the fundus wall. During this time, a portion of the fundus wall displaces to form a cup-shaped portion of the stomach that protrudes from the normal stomach cavity. The device may include a handle having a cup-shaped configuration for forming a cup-shaped portion of the stomach. The apparatus may further comprise a fabrication device for fabricating a cup of the fundus wall with the intergastric sutures. The open ends of the tubular portion are sutured together to form a space that is at least partially surrounded by a portion of the fundus wall. The suturing device may further comprise a suturing device configured to form A plurality of sutures may be provided for suturing two or more sutures simultaneously. The suturing device is inserted through the hole in the fundus wall before the migration restriction device is inserted through the hole in the fundus wall. The movement restriction device may be configured to suture the open end of the cap-shaped portion. and a hole in the fundus wall through which the migration restriction device is expanded. The device further comprises an inflation device at its distal end on the elongate member placed in the stomach. and a first and second suture positioning member provided at the stomach wall at the cup-shaped portion. a first and second suture positioning members positioned in front of each other on either side of the open end; and a first and second suturing member configured to sew the gastric mucosa to the stomach with a row of inter-gastric sutures. The method further includes providing a manipulation device configured to sew an open end of the cup-shaped portion of the bottom wall. The suturing device can be reloaded with sutures from outside the patient's body, The method is configured to suture the open end of the cup-shaped portion of the fundus wall with the row of gastric sutures. A reloadable multiple suturing device may be provided, in which the rows of sutures are suturing simultaneously. The device includes two or more sutures or staples. The present invention provides a migration restriction device to be invaginated into the gastric fundus wall of a human patient to treat reflux disease. The present invention further includes yet another embodiment of a surgical gastroscopic instrument comprising: an elongated member having a proximal end and a distal end, the flexible elongated member being positioned at the distal end; The catheter is then inserted into the patient's throat, esophagus, stomach, and into the fundus wall of the stomach. the elongated member having a diameter smaller than the diameter of the patient's esophagus and being flexible; ) pushing the fundus wall to form a cup-shaped portion of the fundus wall that protrudes outward from the normal gastric cavity The present invention relates to a gastric fundus wall that is adapted to be invaginated into the cup-shaped portion of the gastric fundus wall. (iii) a gastric-to-stomach suture for sealing the cup-shaped portion of the gastric fundus wall; A suture device configured to suture the opening to at least partially encircle the movement restriction device. The instrument is adapted to push the proximal portion of the device to draw the fundus wall inward. The elongate member may further include a forming device disposed on the elongate member. The device is configured to form the fundus wall into an optimal cup-like shape, and the push device The device is then pushed to form the cup-shaped portion of the stomach. first and second suture positioning members disposed on the elongate member at a distal end thereof; and the first and second suture locations with the stomach wall on either side of the open end of the cup-shaped portion. The positioning member is configured to adjust the first and second suturing members in a position in front of each other. and configured to suture the open end of the cup-shaped portion of the fundus wall with a row of intergastric sutures. The suturing device may further include an operating device that is connected to the suturing device. The sutures are reloadable, and the open end of the cup-shaped portion of the fundus wall is sutured with the row of intergastric sutures. and a reloadable multi-suturing device configured to: The row of sutures may include two or more sutures or staples that are sewn together. The suturing device may be a multi-suture device for suturing two or more sutures simultaneously. The instrument may also include an inflation device for inflating the movement restriction device after suturing. The forming device may further include a vice. and aspirating the fundus to assist in forming a cup-shaped portion of the fundus wall. A vacuum suction device may be provided. The endoscopic instrument may include an optical device for examining the inside of the esophagus or stomach. For this purpose, the device may further comprise an electrical wire extending along the elongate member; The optical device also includes a camera disposed distally on the elongated member and connected to the wires. and these wires exit the patient's body for external exposure of the image from the camera. The instrument includes a light source disposed distally on the elongated member to illuminate the inside of the esophagus or stomach. The optical device may be disposed along the elongated member and may be positioned in the esophagus or stomach. Optionally, an optical fiber extending outside the patient's body may be provided to externally examine the inside of the can be done. The present invention further relates to a device for treating reflux disease and obesity. Movement restriction devices and immobilization devices, adjustment devices, wireless remote control functions, wireless energy a transmission device, and a device for treating reflux disease, as described above In addition, the device for the combined treatment of reflux disease is implanted in the patient's body. When swallowed, it stretches part of the patient's stomach wall, thereby affecting the patient's appetite. and at least one operable enlargement device that, when implanted, treats obesity by and an operating device for operating the stretching device to stretch the stomach wall portion to cause fullness. The stretching device is provided at a position where it can stretch the stomach wall. Sutures or staples can be used to keep the stretching device in contact with the stomach wall. In particular, the stretching device can be used to tighten the stomach wall using gastric sutures or staples. The stretching device can be configured to be placed in the gastric cavity. For this purpose, the stretching device is inserted into the gastric cavity via a gastroscope or intraluminal instrument. It may be adapted to be inserted and surgically attached to the stomach wall. Alternatively, the stretching device can be configured to be placed outside the stomach. In an embodiment, the stretching device includes a first catheter configured to engage a first portion of the stomach wall. and a second portion of the stomach wall adjacent to but spaced from the first stomach portion. The manipulation device includes a second engagement member configured to engage with the stomach. first and second engagement members for stretching a portion of the stomach wall between the first and second portions; At least one of the first and second engagement members is configured to be moved away from one another. The method is to fasten the engaging member to the stomach wall by means of an intergastric suture or stapler which holds the engaging member in place. In addition, the first and second engagement portions may be configured to be partially recessed. At least one of the engaging members is secured by a suture or stapler between the engaging member and the stomach wall. At least one of the first and second engagement members may be configured to be held in place. The stretching device is in contact with the stomach wall to ensure that it remains attached to the stomach wall for an extended period of time. The tissue growth promoting structure, preferably a net-like structure, is preferably provided. In another embodiment, the stretching device is invaginated by a portion of the patient's stomach wall. and the operating device is connected to a chamber of the body and The operating device includes a fluid tank in fluid communication with the chamber of the body. When the main body is invaginated, the main body is expanded so that the stomach wall portion is stretched. The fluid reservoir can be operated by hand pressure. The operating device may include a reversing servo, so that a small amount of fluid in the fluid tank can be rotated to a large amount. The chambers in the main body are compressed with a large force, resulting in a large total volume movement with a small force per unit volume. The fluid tank can be placed subcutaneously or intraperitoneally, for example, to connect the motor to the Therefore, it can be adjusted by moving the tank wall. Or, the tank can be moved to the main body. A pump may be provided for pumping fluid or air into the chamber. The term encompasses the definition of devices controlled by larger forces and includes smaller strokes. A stroke, i.e., a very small force can be generated by displacing a small amount of fluid with a large force. Alternatively, or in addition, short A strong force acts on a moving element with a short stroke, while a strong force acts on another moving element with a long stroke. This definition includes the mechanism that converts a small force acting on a large object into a small force acting on the small object. The steps are preferably used when manual control of the device through intact skin is possible. In another embodiment, the device for treating reflux disease and obesity comprises one or more of the following: The chambers have a larger chamber in contact with a smaller chamber. The chambers have a thickness of 100 μm or less distributed between the chambers. The valve is configured to communicate with a fluid or air. It can have a servo, which compresses a small amount of fluid in a large chamber with a large force. A smaller chamber reduces the force per unit volume and causes a larger total volume to be moved. The large chambers help prevent reflux disease by limiting the movement of the cardiac notch towards the patient's diaphragm muscle. The small chamber may be configured to be invaginated into the patient's fundus wall to treat obesity as well. It acts as a stretching device to treat fullness. The large chamber can be used to fill with fluid or air. It can be dispensed into the small chambers to enlarge them and stretch the fundus wall. In another embodiment, the stretching device comprises a mechanical stretching device, A motor may be provided for mechanically adjusting the stretching device. The stretching device is adapted to engage a first portion of the stomach wall and a second portion of the stomach. The mechanically adjusted stretching device may be configured by an operating device. Alternatively, the stretching device may include a joint mechanism configured to be moved. a first engagement member configured to engage a first portion of the stomach wall and a first engagement member configured to engage the first portion of the stomach wall and a second engagement portion configured to engage a second portion of the stomach wall that is spaced apart. The mechanical stretching device may include a first portion and a second portion of the stomach wall. Alternatively, such machines can be operated by hydraulic distribution of fluid or air. The hydraulic means described above can be used to adjust the tensioning device. The stretching device may be non-invasively adjustable after surgery. In its simplest form, the operating device for operating the vice is a stretching device. The device is configured to be operated non-invasively by manually pressing a switch to operate the chair. The device may include a subcutaneous switch for stretching at least two different portions of the stomach wall. The apparatus may include at least two operable enlargement devices configured to: The device is configured to be adjusted post-operatively and non-invasively. One of the stretching devices stretches one of the stomach wall sections, and the second stretches However, the other end of the device may be adjusted from time to time to stretch other portions of the stomach wall. In an embodiment, the stretching device is adapted to fill a volume defined by the stomach wall portion. The body is preferably configured to have no sharp edges that may damage the stomach wall of the patient. When the body is invaginated, it is conveniently held in place by the patient's stomach wall. The body may have a variable circumference so as to remain invaginated within the It may have a shape similar to an organ. In general, any type of mechanical structure may be used. Use any mechanical or pneumatic structure that is mechanically or hydraulically driven When any motor or pump or power is supplied, the form can be changed. The stomach is then inflated by moving at least two portions of the stomach wall away from each other using a moving material. It can achieve the simple goal of stretching a section of a wall. Instead of hydraulic actuation, pneumatic actuation may be used, and the hydraulic fluid Instead, air moves between the tank and the chamber formed by the stretching device. It will be appreciated that the reservoir is preferably held in a desired position when handled by the patient. To compress the tank, this preferably has a locking position. The device remains compressed and is released after compressing again. The hydraulic fluid can be mechanically driven by any motor or pump. It can be operated by using a robot or even manually. Of course, it can also be operated by simply expanding the stomach invagination. The stomach wall is stretched and this operation can be performed mechanically, hydraulically, pneumatically, and by motor or power. This can be done using pump power or by hand.

[0053] The present invention provides a system for the combined treatment of reflux disease and a method for treating obesity as described above. The present invention also provides an obesity treatment system comprising an apparatus for treating obesity. and a subcutaneous electrical switch configured to manually and non-invasively control the function of The system can include a hydraulic device having a hydraulic tank, The device for treating the pulmonary circulation is configured to be non-invasively adjusted by manually applying pressure to a hydraulic tank. The system is provided with a wireless remote control for controlling the functions of the device. The wireless remote control device has at least one external signal transmitter and an internal signal receiver. A wireless remote control device can be provided and implanted in the patient's body. The wireless control signal is configured to transmit at least one wireless control signal to Wavelength-, amplitude-, or phase-modulated signals, or combinations thereof; and analog or digital signals, or a combination of analog and digital signals Alternatively, the wireless control signal may include an electric or magnetic field, or a combined electromagnetic field. The remote control device is capable of transmitting a carrier signal for carrying wireless control signals. The transmitted signal can be digital, analog, or a combination of digital and analog signals. The remote control may include a digital or analog control signal. The system can transmit an electromagnetic carrier signal for the purpose of The device may include a wireless energy transmitter for non-invasively powering the device. The energy transmission device transmits energy by at least one wireless energy signal. Wireless energy signals include sound wave signals, ultrasonic signals, electromagnetic wave signals, infrared signals, and visible light signals. signals, ultraviolet light signals, laser light signals, microwave signals, radio signals, X-ray signals, and gamma The signal may include a wave signal selected from a line signal, or a wireless energy signal. The wireless energy transmission device is a wireless energy A carrier signal for carrying a digital signal can be transmitted. They can include digital signals, analog signals, or a combination of digital and analog signals. The system includes a first form of wireless energy for converting the first form of wireless energy into a second form of energy. The energy transforming device may include an energy transforming device for direct Additionally, upon energy transfer, the device can be operated with energy in the second form. Energy in the form of DC or pulsating DC, or a combination of DC and pulsating DC, The second form of energy includes alternating current or a combination of direct current and alternating current. An accumulator may be provided, and the energy in the second form may be At least a portion of the current is used to charge the accumulator. Energy includes magnetic energy, kinetic energy, acoustic energy, and chemical energy. , radiant energy, electromagnetic energy, light energy, nuclear energy, or thermal energy. One of the first form of energy and the second form of energy is Non-magnetic energy, non-kinetic energy, non-chemical energy, non-acoustic energy, non-nuclear energy The system may be a thermal energy source or a non-thermal energy source to power the device. The energy source may include an energy source configured to: An internal energy source configured to receive energy from an external energy source that transmits energy The internal energy source can include a power source. The charge will be credited.

[0054] The system includes a patient's internal body sensor for providing feedback information related to functional parameters. The system may include a feedback device for transmitting information from the system to outside the body. The system is related to the energy transfer to charge the internal energy source. A sensor may be provided to sense a parameter, such as a functional parameter. An internal control unit for controlling an operating device of the device in response to a sensor that senses the data. Alternatively, the sensor may include a unit for sensing a body parameter of the patient. The body parameter can be one of the following: temperature, blood pressure, blood flow, heart rate, and respiration. Body parameter sensors can include pressure or motility sensors or sensors that measure There are sensors that detect body parameters such as weight, stretching, or food intake. The control device can be controlled in response to a sensor that detects the data. An internal control unit may be provided to receive information from the operating device of the device. The operating device may comprise a motor or a pump. In particular, the operating device may comprise an electric motor. The operating device may be electrically powered or may be a hydraulic operating device. or a pneumatically operated device. The energy transferred affects the operating device, stretching the device during the energy transfer. The system can generate kinetic energy to operate a device. Transmitting information from inside the patient's body to outside the body to provide feedback information related to the parameters The system may be equipped with a feedback device to receive external data. The present invention provides an implantable internal data communication device for communicating with a communication device and an external data communication device. and the internal communication device can communicate data related to the device or the patient for treating obesity. It is configured to provide feedback to an external data communication device or The communication device supplies data to the internal data communication device. The system has at least one voltage level. Implantable electrical device with bell protection device and / or at least one constant current protection device It may include components.

[0055] The present invention also provides a method of treating a patient suffering from both reflux disease and obesity. These methods may be used in conjunction with the abdominal or intracavitary therapies described above to treat reflux disease. The present invention provides the following methods.

[0056] a) a method for surgically treating an obese patient, comprising: incising an opening in the patient's abdominal wall; making an incision in an area around the stomach; placing a device for treating obesity as described above and engaging a stomach wall of a patient; and suturing the stomach wall.

[0057] This method is After surgery, the stretching device is adjusted to remove part of the stomach wall, affecting the patient's appetite. The method may further include the additional step of stretching, and the step of adjusting the stretching device. The pump is controlled from outside the patient's body.

[0058] This method is An additional device for treating obesity is placed as described above, and an additional stage is placed to engage the patient's stomach wall. Top and the additional step of stretching a first portion of the stomach wall using a device for treating obesity; the additional step of stretching a second portion of the stomach wall with an additional device for treating obesity. It may further include:

[0059] b) Surgically inserting a device to treat a patient's obesity via a laparoscopic abdominal approach. A method for placing a A needle or tubular instrument is inserted into the abdominal portion of the patient's body and the needle or tubular instrument is used filling the patient's abdomen with gas, thereby expanding the patient's abdominal cavity; placing at least two laparoscopic trocars within the patient; inserting a camera through one of the laparoscopic trocars into the patient's abdomen; Pass at least one cutting tool through one of at least two laparoscopic trocars. and incising the intended placement area in the patient. and placing the device for treating obesity as described above and engaging the stomach wall. Law.

[0060] c) A method of using the system for treating obesity as described above, comprising the steps of: The device can be adjusted after surgery to stretch parts of the stomach wall in a way that affects the patient's appetite. wherein the step of adjusting the stretching device is performed non-invasively. The stretching device may comprise a mechanical or hydraulic stretching device. The hydraulic stretching device applies a gel or gas or fluid to the stretching device. Alternatively, a tank may be provided for transporting the tank from the stretching device. To manually transfer fluid to and from the stretching device, The stretching device can be placed subcutaneously within the patient's reach for the purpose of stretching. It can be powered by an internal energy source to stretch or release the A control device can be used to control power from an internal control unit or from outside the patient's body. A wireless energy transmission device for wireless energy transmission supplies power to the operation device. This allows the stretching device to directly contact the stomach during energy transfer. The wireless energy transmission device for wireless energy transmission is an internal energy It can be equipped with a reversing servo to provide a small amount of power in a closed hydraulic system. The fluid movement occurs within a second, larger closed hydraulic system. This results in a small amount of fluid being moved with a high force per unit area compared to a large volume. The stretching device invaginated within the fundus wall is configured to be adjustable, and The stretching device, which is placed in the stomach, is adjusted to stretch the fundus wall, thereby promoting satiety. The method is configured to:

[0061] The method includes administering a subject from within the body to provide feedback related to a functional parameter of the device. The method may further include transmitting feedback information to an outside of the body. The method uses a fluidic device to provide feedback related to the patient's physical parameters. The device may further include transmitting feedback information to the device. may be correlated with the transfer of energy to charge an internal energy source. The device is programmable from outside the patient's body.

[0062] This method is Sensing a physical parameter of the patient or a functional parameter of the device; A sensor that transmits the sensing information to a control unit configured to adjust the stretching device. The method may further include a step.

[0063] This method is Sensing a physical parameter of the patient or a functional parameter of the device; Sending the sensing information to a control unit configured to regulate the charging of the internal energy source. and receiving the signal.

[0064] The method involves subcutaneous placement of a reversing servo with a small control tank and a The higher force displaces a small amount from the control tank and the smaller force per unit area is stretched. and generating a greater movement of the vice.

[0065] The method further includes performing the non-invasive adjustment by manually pressing a subcutaneous switch. It is possible to do so.

[0066] The method may further include performing the non-invasive adjustment by a wireless remote control device. Cut.

[0067] The method further includes performing the non-invasive conditioning by a wireless energy transmission device. This can be done.

[0068] The method includes powering a device for treating obesity with an internal energy source. It may further include:

[0069] The method includes providing a device for treating obesity with an external energy source that transmits wireless energy. The device may further include powering the device, the energy source transmitting wireless energy. The device is equipped with an external energy source that transmits

[0070] The method comprises transmitting wireless energy from an external energy source and a rechargeable internal energy source. The method may further include charging the

[0071] d) A method of using an apparatus as described above, the stretching device stretching the stomach wall. A large chamber in contact with one or more smaller tanks / chambers configured to The chambers are adapted to communicate with a fluid or air to be transferred between the chambers. How it is configured.

[0072] e) A method of using a device as described above, in which the large chamber, together with its main volume, is subjected to a suction The small chamber is designed to be the most important volume of the stretching device and is ideal for treating obesity. It acts as a stretching device to stretch the stomach wall, and the main chamber is diverted into a smaller chamber. A method for treating obesity by communicating with the body or gel and creating a stretching effect within the fundus wall of the stomach.

[0073] f) A method of using a device as described above, comprising the steps of: The device treats reflux disease by restricting the movement of the gastric notch toward the patient's diaphragm muscle. The small chamber is used to stretch the fundus wall and to transfer fluid from the large chamber to the small chamber. or air communication to induce a stretching effect in the fundus wall of the stomach to treat obesity. How to do it.

[0074] In another aspect, the present invention relates to a method for treating reflux disease and / or obesity in a patient having a stomach with a food cavity. The present invention relates to an apparatus for treating a gastric cancer, the apparatus generally comprising: at least one volume filling device configured to be substantially invaginated into the volume of the The filling device is configured to be placed on the outside of the stomach wall, thereby increasing the volume of the food cavity. The volume filling device is reduced in size by a volume substantially exceeding the volume of the volume filling device. The surface of the volume filling device comprises a biocompatible material, and a substantial portion of the surface of the volume filling device is adjacent to the outer surface of the stomach wall. and the volumetric filling device is configured to abut against a maximum outer diameter of at least 30 mm. The apparatus preferably includes an inflatable device that is expandable to an expanded state. The inflatable device preferably includes an inlet for a fluid or gel. The inlet preferably has a volume filling device and is configured to be connected to a gastroscopic instrument. and a fluid connection configured to interconnect the device and the gastroscope instrument. The filling device has an elongated shape. Alternatively, the volume filling device has a round shape, or The volumetric filling device preferably has a bent or curved shape. The volume filling device preferably comprises a biocompatible material. The filling device includes a silicone. The volumetric filling device includes a parylene coating, a poly 1. Tetrafluoroethylene coating, polyurethane coating, etc. The volumetric filling device may be coated with a coating of one or more layers. In one embodiment, the fluid comprises a fluid configured to be transformed into a state or fixed form. In another embodiment, the fluid is isotonic. The fluid contains macromolecules to prevent diffusion. In another embodiment, the fluid contains iodine molecules. The volumetric filling device includes a homogenous material. The volumetric filling device can be a solid. The housing may have an enclosure wall defining a chamber, may have a rigid outer surface, and may have a resilient outer surface. The volumetric filling device may preferably include: It has a maximum circumference of at least 50 mm, more preferably at least 80 mm. The volumetric filling device preferably has a circumference of 0.00001 to 0. 001m 3 up to 0.00001 to 0.0002 m 3 With a volume of Preferably, the volume filling device is adapted for insertion into a laparoscopic trocar, the volume filling device having a maximum The volume filling device can be easily attached to the stomach by means of intergastric sutures or staplers. The device is configured to be held in place and to invaginate the stomach wall. The LA has a structure adapted to contact the stomach wall to promote in-growth of human tissue. The device has a fixing portion to ensure long-term placement of the volume filling device attached to the stomach wall. The structure preferably comprises a net-like structure. The volume filling device is adapted to be non-invasively inserted after surgery. In one embodiment, the volume filling device is configured to be dynamically adjustable. It has a variable perimeter that is well-configured to remain invaginated in place within the stomach wall. The device is a stretching device configured to be placed on the outside of the stomach wall and stretch a portion of the stomach wall. The apparatus further comprises an appetite control device, which can affect the patient's appetite. There is further provided a fluid connection interconnecting the stretching device and the volume filling device. In one embodiment, the volume filling device is adapted to be placed externally on the stomach wall via a gastroscopic instrument. In one embodiment, the volume filling device is configured to include at least two interconnectable and the volume filling device is configured to be placed outside the stomach wall as separate sections. In one embodiment, the outer surface layer of the volume filling device is made of polyurethane, Teflon ( In one embodiment, the container comprises a container holder. The loading device is configured to be destroyed by acid, preferably hydrochloric acid. In the form, the volumetric filling device comprises a gel, preferably the gel has a Shore value of less than 15. In one embodiment, the volume filling device is configured to cooperate with the gripping instrument. In one embodiment, the volume filling device comprises an attachment device attached to the stomach wall of the patient. The apparatus is configured to be fully invaginated by the implanted volume filling device. Sometimes the food intake reduction device is secured to the stomach wall to hold the volume filling device in place The volumetric filling device may further include a fixing device configured to: 0002m 3 and preferably has a volume of 0.0001 to 0.001 m 3 With a volume of up to In one embodiment, the volumetric filling device is resistant to destruction by acid, preferably hydrochloric acid. Preferably, the volumetric filling device is configured to have a length of at least 120 mm, more preferably Preferably at least 150 mm, more preferably at least 180 mm, even more preferably Preferably it has a circumference of at least 220 mm. The volumetric filling device preferably comprises: The device preferably comprises a flexible, inelastic material that is adapted to aid in the fixation of the device to the stomach wall. In one embodiment, the volume filling device includes a fixing device configured to fix the volume of the filling material. The loading device may comprise two or more catheters configured to participate in the fixation of the device to the stomach wall. In one embodiment, the volume filling device is held by the instrument and A retention device is provided that is configured to allow simplified implantation of the device. In one embodiment, the volume filling device is held by an instrument to facilitate implantation of the device. The device includes two or more holding devices configured to allow the device to be simplified. In an embodiment, the volume filling device includes at least one tube connected to the device. In one embodiment, the volume filling device comprises an inlet for connection to said tubing. Prepare.

[0075] A reflux device and / or obesity in a patient with at least one volumetric filling device The devices thus described for treating include, but are not limited to, stretching cardia stimulation devices. At least one of the features disclosed in the previous section can be combined with the features disclosed in the previous section. Thus, for treating reflux disease and / or obesity in a patient with a volume filling device The described device is suitable for use in abdominal or intracavitary treatment as outlined in the previous sections of this specification. that it can be embedded generally by using the It is also contemplated that suitable features of the movement restriction device may be used in conjunction with the volumetric filling device. do.

[0076] Any embodiment or part of an embodiment or feature or method described herein or related systems or parts of systems may be combined in any combination Note that it is possible to

[0077] The invention will now be described in more detail by way of non-limiting examples and with reference to the accompanying drawings, in which: Explained. [Brief description of the drawings]

[0078] [Figure 1A] 1A-1D are schematic diagrams illustrating various embodiments of devices for treating gastroesophageal reflux disease implanted within a human patient. [Figure 1B] 1A-1D are schematic diagrams illustrating various embodiments of devices for treating gastroesophageal reflux disease implanted within a human patient. [Figure 1C] 1A-1D are schematic diagrams illustrating various embodiments of devices for treating gastroesophageal reflux disease implanted within a human patient. [Figure 2A] 1A-1D are schematic diagrams illustrating various embodiments of devices for treating gastroesophageal reflux disease implanted within a human patient. [Figure 2B] 1A-1D are schematic diagrams illustrating various embodiments of devices for treating gastroesophageal reflux disease implanted within a human patient. [Figure 3A] 1A-1D are schematic diagrams illustrating various embodiments of devices for treating gastroesophageal reflux disease implanted within a human patient. [Figure 3B] 1A-1D are schematic diagrams illustrating various embodiments of devices for treating gastroesophageal reflux disease implanted within a human patient. [Figure 4A] 1 is a schematic diagram illustrating an embodiment of a device for treating gastroesophageal reflux and obesity implanted within a human patient. [Figure 4B] 1 is a schematic diagram illustrating an embodiment of a device for treating gastroesophageal reflux and obesity implanted within a human patient. [Figure 4C] 1 is a schematic diagram illustrating an embodiment of a device for treating gastroesophageal reflux and obesity implanted within a human patient. [Figure 4D] 1 is a schematic diagram illustrating an embodiment of a device for treating gastroesophageal reflux and obesity implanted within a human patient. [Diagram 5] FIG. 1 is a schematic diagram illustrating one embodiment of a device for treating gastroesophageal reflux disease implanted within a human patient. [Figure 6A] 1A-1C show alternative configurations of a movement restriction device for treating gastroesophageal reflux disease configured to be implanted within a human patient. [Figure 6B] 1A-1C show alternative configurations of a movement restriction device for treating gastroesophageal reflux disease configured to be implanted within a human patient. [Figure 6C] 1A-1C show alternative configurations of a movement restriction device for treating gastroesophageal reflux disease configured to be implanted within a human patient. [Figure 6D] 1A-1C show alternative configurations of a movement restriction device for treating gastroesophageal reflux disease configured to be implanted within a human patient. [Figure 7] 1A-1C show alternative configurations of a movement restriction device for treating gastroesophageal reflux disease configured to be implanted within a human patient. [Figure 8] 1A-1C show alternative configurations of a movement restriction device for treating gastroesophageal reflux disease configured to be implanted within a human patient. [Figure 9] 1A-1C show alternative configurations of a movement restriction device for treating gastroesophageal reflux disease configured to be implanted within a human patient. [Figure 10] FIG. 1 is a general view showing a patient using an implanted movement restriction device for treating gastroesophageal reflux disease. [Figure 11] 1 is a schematic diagram showing various methods of powering a device for treating gastroesophageal reflux disease. [Figure 12]1 is a schematic diagram showing various methods of powering a device for treating gastroesophageal reflux disease. [Figure 13] 1 is a schematic diagram showing various methods of powering a device for treating gastroesophageal reflux disease. [Figure 14] 1 is a schematic diagram showing various methods of powering a device for treating gastroesophageal reflux disease. [Figure 15] 1 is a schematic diagram showing various methods of powering a device for treating gastroesophageal reflux disease. [Figure 16] 1 is a schematic diagram showing various methods of powering a device for treating gastroesophageal reflux disease. [Figure 17] 1 is a schematic diagram showing various methods of powering a device for treating gastroesophageal reflux disease. [Figure 18] 1 is a schematic diagram showing various methods of powering a device for treating gastroesophageal reflux disease. [Figure 19] 1 is a schematic diagram showing various methods of powering a device for treating gastroesophageal reflux disease. [Figure 20] 1 is a schematic diagram showing various methods of powering a device for treating gastroesophageal reflux disease. [Figure 21] 1 is a schematic diagram showing various methods of powering a device for treating gastroesophageal reflux disease. [Figure 22] 1 is a schematic diagram showing various methods of powering a device for treating gastroesophageal reflux disease. [Diagram 23] 1 is a schematic diagram showing various methods of powering a device for treating gastroesophageal reflux disease. [Figure 24] 1 is a schematic diagram showing various methods of powering a device for treating gastroesophageal reflux disease. [Diagram 25] 1 is a schematic diagram showing various methods of powering a device for treating gastroesophageal reflux disease. [Figure 26] 1 is a schematic diagram showing various methods of powering a device for treating gastroesophageal reflux disease. [Figure 27] 1 is a schematic diagram showing various methods of powering a device for treating gastroesophageal reflux disease. [Figure 28] 1A-1C are schematic diagrams illustrating various ways in which the device of the present invention for treating gastroesophageal reflux disease can be hydraulically or pneumatically powered. [Figure 29] 1A-1C are schematic diagrams illustrating various ways in which the device of the present invention for treating gastroesophageal reflux disease can be hydraulically or pneumatically powered. [Diagram 30] 1A-1C are schematic diagrams illustrating various ways in which the device of the present invention for treating gastroesophageal reflux disease can be hydraulically or pneumatically powered. [Diagram 31] 1A-1C are schematic diagrams illustrating various ways in which the device of the present invention for treating gastroesophageal reflux disease can be hydraulically or pneumatically powered. [Diagram 32] 1A-1C are schematic diagrams illustrating various ways in which the device of the present invention for treating gastroesophageal reflux disease can be hydraulically or pneumatically powered. [Diagram 33] 1A-1C are schematic diagrams illustrating various ways in which the device of the present invention for treating gastroesophageal reflux disease can be hydraulically or pneumatically powered. [Diagram 34] 1A-1C are schematic diagrams illustrating various ways in which the device of the present invention for treating gastroesophageal reflux disease can be hydraulically or pneumatically powered. [Diagram 35] 1 is a flow chart illustrating steps performed when implanting a movement restriction device for treating gastroesophageal reflux disease. [Diagram 36] 1 illustrates a method for restoring the alignment of the cardia and fundus in a patient suffering from reflux disease. [Figure 37] 1 illustrates a method for restoring the alignment of the cardia and fundus in a patient suffering from reflux disease. [Figure 38] 1 illustrates a method for restoring the alignment of the cardia and fundus in a patient suffering from reflux disease. [Figure 39] 1 illustrates a method for restoring the alignment of the cardia and fundus in a patient suffering from reflux disease. [Diagram 40] 1 illustrates a method for restoring the alignment of the cardia and fundus in a patient suffering from reflux disease. [Diagram 41] 1 illustrates a method for restoring the alignment of the cardia and fundus in a patient suffering from reflux disease. [Diagram 42] 1A-1C show different shapes and features of reflux treatment devices included in an apparatus according to the present invention. [Diagram 43] 1A-1C show different shapes and features of reflux treatment devices included in an apparatus according to the present invention. [Diagram 44] 1A-1C show different shapes and features of reflux treatment devices included in an apparatus according to the present invention. [Diagram 45] 1A-1C show different shapes and features of reflux treatment devices included in an apparatus according to the present invention. [Figure 46] 1A-1C show different shapes and features of reflux treatment devices included in an apparatus according to the present invention. [Figure 47a] FIG. 2 shows an inflatable reflux treatment device in a deflated state including an apparatus according to the present invention and an implement for placing the reflux treatment device on the outside of a patient's stomach wall. [Figure 47b] FIG. 2 shows an inflatable reflux treatment device in a deflated state including an apparatus according to the present invention and an implement for placing the reflux treatment device on the outside of a patient's stomach wall. [Figure 47c] FIG. 2 shows an inflatable reflux treatment device in a deflated state including an apparatus according to the present invention and an implement for placing the reflux treatment device on the outside of a patient's stomach wall. [Fig. 47d] FIG. 2 shows an inflatable reflux treatment device in a deflated state including an apparatus according to the present invention and an implement for placing the reflux treatment device on the outside of a patient's stomach wall. [Figure 48a] 47b-47c show different steps of invaginating the inflatable device of FIG. 47a into the outside of the stomach wall of a patient. [Figure 48b] 47b-47c show different steps of invaginating the inflatable device of FIG. 47a into the outside of the stomach wall of a patient. [Fig. 48c] 47b-47c show different steps of invaginating the inflatable device of FIG. 47a into the outside of the stomach wall of a patient. [Fig.48d]47b-47c show different steps of invaginating the inflatable device of FIG. 47a into the outside of the stomach wall of a patient. [Figure 48e] 47b-47c show different steps of invaginating the inflatable device of FIG. 47a into the outside of the stomach wall of a patient. [Fig.48f] 47b-47c show different steps of invaginating the inflatable device of FIG. 47a into the outside of the stomach wall of a patient. [Figure 48g] 47b-47c show different steps of invaginating the inflatable device of FIG. 47a into the outside of the stomach wall of a patient. [Fig. 48h] 47b-47c show different steps of invaginating the inflatable device of FIG. 47a into the outside of the stomach wall of a patient. [Figure 48i] 47b-47c show different steps of invaginating the inflatable device of FIG. 47a into the outside of the stomach wall of a patient. [Figure 49] FIG. 1 illustrates an embodiment in which the reflux treatment device is also configured to treat obesity. [Figure 50] FIG. 1 illustrates an embodiment in which the reflux treatment device is also configured to treat obesity. [Figure 51] FIG. 1 illustrates an embodiment in which the reflux treatment device is also configured to treat obesity. [Figure 52a] 47b-47c show different steps of invaginating the inflatable device of FIG. 47a inside the stomach wall of a patient. [Fig. 52b] 47b-47c show different steps of invaginating the inflatable device of FIG. 47a inside the stomach wall of a patient. [Fig. 52c] 47b-47c show different steps of invaginating the inflatable device of FIG. 47a inside the stomach wall of a patient. [Fig. 52d] 47b-47c show different steps of invaginating the inflatable device of FIG. 47a inside the stomach wall of a patient. [Figure 52e] 47b-47c show different steps of invaginating the inflatable device of FIG. 47a inside the stomach wall of a patient. [Fig. 52f] 47b-47c show different steps of invaginating the inflatable device of FIG. 47a inside the stomach wall of a patient. [Fig. 52g] 47b-47c show different steps of invaginating the inflatable device of FIG. 47a inside the stomach wall of a patient. [Fig. 52h] 47b-47c show different steps of invaginating the inflatable device of FIG. 47a inside the stomach wall of a patient. [Figure 53a] FIG. 1 shows an instrument for forming an invagination of the stomach wall. [Figure 53b] FIG. 1 shows an instrument for forming an invagination of the stomach wall. [Fig. 53c] FIG. 1 shows an instrument for forming an invagination of the stomach wall. [Figure 54] FIG. 1 illustrates an abdominal therapy for treating reflux disease. [Figure 55] FIG. 1 illustrates an abdominal therapy for treating reflux disease. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0079] FIG. 1A shows a catheter for treating reflux disease according to the present invention implanted in a human patient. 1A is a schematic diagram showing an apparatus 11 including a movement restriction device 10 made of a biocompatible material. In FIG. 1, the device 10 is invaginated into the fundus of the stomach. The device 10 is attached to the patient's diaphragm 1 8 and at least a portion of the lower portion of the invaginated fundus wall 16, 6a. When device 10 is invaginated in this manner, the cardiac notch of the patient's stomach toward the patient's diaphragm is invaginated. The movement is restricted, which allows the cardia to slide through the patient's diaphragmatic opening and into the patient's thoracic cavity 20. and the supportive pressure exerted by the patient's abdomen against the patient's cardiac sphincter is Will be maintained.

[0080] The body 13 is expandable and configured to expand with a gel or fluid. A fluid or gel containing member for containing a fluid to inflate the movement restriction device. Alternatively, the body 13 may comprise a homogenous material and be a solid body. Alternatively, the body 13 may have an outer wall in the form of an enclosure wall defining a chamber. If the outer wall is rigid, it will not move in response to stomach motility. Therefore, it has sufficient rigidity to remain undeformed even when subjected to the resulting force.

[0081] The body 13 of the movement restriction device 10 can be secured to the wall 16a of the fundus 16 in a number of different ways. In the embodiment shown in FIG. 1A, the device 10 is inserted from outside the stomach. After invagination, a first set of multiple intergastric sutures or staples 22a is inserted into the fundus wall. The fixation device is used to keep the invagination intact for a short period of time, allowing the human tissue to be inserted. This allows the invagination to remain intact for extended periods of time.

[0082] Optionally, the device 10 is attached to the patient's diaphragm 18 and at least a portion of the lower portion of the invaginated fundus wall 16a. between the wall 16a of the fundus 16 and the wall 24a of the esophagus 24 to hold the portion in position There is a second fixation device consisting of multiple sutures or staples 22b provided at the The device 10 may thus be held in this position by this second fixing device. The device 10 is secured directly or indirectly to the diaphragm muscle 18 or associated muscles. Alternatively, the device 10 can be fixed directly or intermittently to the esophagus. Alternatively, or in addition, device 10 may be fixed in position. Sutures or staples are placed between the wall 16a of the fundus 16 and the diaphragm 18 to hold the stomach in place. There may be a third fixation device in the form of a puller 22c.

[0083] FIG. 1B illustrates an embodiment substantially similar to that shown in FIG. 1A. In B, the main body 13 and the invagination are connected to the reflux main body 13 and the diaphragm 18 in addition to the fixing part 22. The device is secured to the cardia 14 using sutures and / or staples 22c between the is held in position.

[0084] FIG. 1C illustrates another embodiment substantially similar to that shown in FIG. 1A. In FIG. 1C, the reflux treatment device is shown in FIG. 1C, which illustrates a gastric wall 16a connecting the wall 16a of the gastric fundus 16 to the wall 16a of the gastric fundus 16. The reflux treatment device is held in place by an interstitial suture or stapler 22a. The vise 10 is adapted to attach a suture 22b or staple 22b from the wall 16a of the stomach fundus to the wall of the esophagus 24a. The gastric fundus 16a is held in place by a suture or stapler from the wall of the fundus 16a to the diaphragm. is held in place by

[0085] An alternative embodiment of a device 17 for the treatment of reflux disease according to the present invention is shown in FIG. 2A. This embodiment has in many respects the same structure as described above with reference to Figures 1A-C. Accordingly, the movement restriction device 10 may be implanted in a human patient and However, in the embodiment shown in FIG. The stomach is invaginated from the inside of the stomach, not from the outside, as in Figures 1A-C. The motion restriction device 10 is adapted to contact at least one of the patient's diaphragm 18 and the lower portion of the invaginated gastric fundus wall 16. The body 13 is configured to abut against a portion of the inner wall of the fundus wall 16 at a position between the In this embodiment, the body 13 is adapted to receive the cardiac region of a human or mammalian patient in an upright position. The body 13 of the device 10 is placed over the fundus 16 wall 16a. and further has an outer surface 15 adapted to abut against the fundus wall. When device 10 is invaginated in this manner as described above with respect to FIG. The movement of the cardiac notch of the patient's stomach towards the patient's diaphragm is restricted, which causes the cardiac ) and is prevented from entering the patient's thoracic cavity 20 through the patient's diaphragmatic opening, Supportive pressure exerted by the patient's abdomen against the cardiac sphincter is maintained.

[0086] After invagination, multiple intergastric sutures or staples 33a including the first fixation device are inserted in a short time. The procedure is performed from the inside of the stomach 16 to keep the invagination intact during the procedure. This allows the human tissue to be The device 10 can be placed in the position such that the invagination remains intact for an extended period of time. To hold the ligament in place, an additional suture or stapler 22b may be used that includes a second fixation device. , a wall portion 16b of the fundus 16 and a wall 24a of the esophagus 24 that form part of the invagination of the device 10. Similarly, sutures may be provided between the device 10 and the A third fixation device in the form of a thread or stapler 22c is attached to a portion of the invagination of the device 10. It may be provided between the diaphragm 18 and another wall portion 16c of the fundus 16 forming the gastric wall.

[0087] An alternative embodiment is shown in FIG. 2B. This embodiment may, in many respects, be similar to that shown in FIG. A. However, here the sutures and The staplers 22b and 33a are all connected to the fixture of the reflux treatment device 10. The embodiment is devoid of gastro-diaphragmatic sutures or staples.

[0088] An alternative embodiment of a device 19 for the treatment of reflux disease is shown in FIG. In many embodiments, those described above with reference to Figures 1A-C and 2A-B. Thus, the movement restriction device 10 may be implanted in a human patient. The device 10 is shown inserted into the stomach at a location between the patient's diaphragm 18 and the fundus wall 16. The base 16 includes a body 13 configured to abut a portion of the base wall 16. However, this alternative In this embodiment, device 10 is not invaginated within stomach 16. Instead, fixation of device 10 is performed. The section is configured to attach the reflux treatment device to the stomach wall to ensure long-term placement of the device. an attachment structure configured to contact the bottom wall 16a and promote the growth of human tissue; The attachment structure 10a preferably comprises a net-like structure. To achieve this, a first fixation device in the form of a suture or stapler 44a is applied for a short period of time. A gap may be provided between the attachment structure 10a and the fundus wall 16a.

[0089] The attachment structure 10a secures the device 10 between the patient's diaphragm 18 and the fundus wall 16. A wall 24a of the esophagus 24 is provided between the wall 16a of the fundus 16 and the wall 24a of the esophagus 24 to hold the gastric The device may be configured for a second fixation device in the form of a suture or stapler 44b. Similarly, the attachment structure 10a again holds the device 10 in said position. To hold the stomach in place, a suture or stay is provided between the wall 16a of the fundus 16 and the diaphragm 18. It may be configured with a third fastening device in the form of a plug 44c.

[0090] An alternative embodiment is shown in FIG. 3B. This embodiment may, in many respects, be similar to that shown in FIG. In this embodiment, the reflux treatment device is similar to that described with reference to A. The attachment structure 10a is inserted into the stomach from the inside as shown in FIG. , the wall 16 of the fundus 16 over and around the invagination formed by the reflux treatment device 10 It is positioned on a.

[0091] An alternative embodiment of a device 21 for the treatment of reflux disease according to the present invention is shown in FIG. 4A. This embodiment has in many respects the same structure as described above with reference to Figures 1A-C. In FIG. 4A, a diagram of a device 10 for the treatment of reflux disease according to the present invention is shown. The surface is shown as it would be implanted in a human patient. In FIG. 4A, the movement restriction device The device 10 is again invaginated within the gastric fundus 16. The device 10 is in contact with the patient's diaphragm 18. At least a portion of the lower portion of the invaginated fundus wall 16 is located between the outer wall 16a of the fundus wall 16 and the The body 13 has an outer surface 15 adapted to abut a portion of the fundus 1. 6. Thus, the device 10 is shaped to abut the outer wall 16a of the When the patient is invaginated, the cardiac notch of the patient's stomach is restricted from moving toward the patient's diaphragm, which This prevents the cardia from sliding through the patient's diaphragmatic opening and into the patient's thoracic cavity 20. Supportive pressure exerted by the patient's abdomen against the patient's cardiac sphincter is maintained.

[0092] In the embodiment of FIG. 4A, similar to the embodiment of FIG. 1A, the device 10 is invaginated within the fundus 16. Then, a first fixation device consisting of multiple stomach-to-stomach sutures or staples 22a is used. , keeping the invagination intact for a short period of time. A number of stitches are provided between at least a portion of the device 10 to hold the device 10 in position. A second fastening device consisting of a doubling suture or stapler 22b is provided. Again, the wall 16a of the fundus 16 and the diaphragm 16 are interposed between the device 10 and the stomach 10 to hold the device 10 in position. 8, a third fastening device in the form of a suture or stapler 22c may be provided between the can.

[0093] In the embodiment shown in FIG. 4A, the size of the movement restriction device 10 is The device 10 is connected to the device 10 by leads 52b. 5. The device is coupled to a hydraulic tank 52 which is connected to the device, thereby allowing non-invasive operation by manually pressing the tank 52. The device 10 can then be moved to one or more smaller chambers 10b. Connected.

[0094] Additionally, the above embodiments may alternatively be used to treat obesity. In this embodiment, the volume of the movement limiting body 13 is used to store the fluid, and further, when the fluid is filled One or more smaller chambers 10b connected to the body 13 with a pump to be filled The present invention is configured to treat obesity by stretching the fundus wall of the stomach to induce satiety using The small chamber 10b is also adapted to be invaginated into the fundus wall and filled with fluid. Sometimes, enlargement occurs, resulting in feedback from human sensors that leads to satiety. By placing a small hydraulic tank / pump under the patient's skin, the patient can operate the device on demand. Liquid can be pumped into the small chambers to fill them and make you feel full.

[0095] An alternative embodiment is shown in Figure 4B. This embodiment is an alternative to that shown in Figure 4A. The reflux treatment device 10 and the chamber 10b are controlled in a different manner. Here, chamber 10b is not controlled by a subcutaneous pump, but by an internal control unit 56 which is powered by the The internal control unit 56 controls the digital inputs for the treatment of reflux and / or obesity. The device includes a means for the patient to control how the device 10 is used. A means for providing power may also be provided.

[0096] The internal control unit 56 controls the battery 70, the electrical switch 72, the motor / pump 44, the tank, 52, and an inlet 1001. An energy transmission device with a remote control The sensor 34 is configured to control and power the device. depending on the situation, e.g., the device is electrical, hydraulic, pneumatic, or mechanical. is selected depending on whether

[0097] The control unit may receive input from sensors 76, in particular pressure sensors. The internal control unit 56 may also include sensors of the following types: A or MCU or ASIC or any other form of circuit, component or memory (For a more detailed explanation, see the "System" section below.) (Reflecting light.)

[0098] FIG. 4C shows that instead of two small chambers as in 4A, there is one small chamber 10b. It is essentially the same as Figure 4A, with some differences. Figure 4C shows the small chamber 10b in an empty state. 4D shows the small chamber 10b when it is filled and expanded to full capacity. is doing.

[0099] Yet another alternative embodiment of a device 23 for the treatment of reflux disease according to the present invention is shown in FIG. This embodiment, again in many aspects, is shown in FIG. Thus, in the embodiment of FIG. 1A, The movement restriction device 10 is invaginated into the fundus of the stomach so that it is in contact with the patient's diaphragm 18 and the invaginated portion. abutting against a portion of the outer wall 16a of the fundus wall 16 at a position between the fundus wall 16 and at least a portion of the lower portion of the fundus wall 16; The device 10 comprises a body 13 having an outer surface 15 adapted to be inserted into the stomach. The endoscopic catheter has a shape that contacts the outer wall 16a of the fundus 16 and has a generally smooth shape that is suitable for contacting the fundus wall. The device 10 has a smooth outer surface 15. After the device 10 is invaginated into the fundus 16, multiple intergastric A first fixation device consisting of a suture or stapler 22a is used to briefly fix the invagination. To hold the device 10 in place, the wall 16a of the fundus 16 and the esophagus are kept intact. A second fastening member 22b is provided between the wall 24a of the suturing member 22 and the wall 24a of the suturing member 22. A determination device is provided.

[0100] In an alternative embodiment shown in FIG. 5A, device 23 stimulates the cardiac muscle to further expand the cardiac cavity. A stimulation device for delivering stimulation pulses configured to close to further prevent reflux disease. The device 23 further comprises a device 26. The device 23 comprises at least one conductor 26a and a device for receiving a stimulation pulse. and at least one electrode 26b configured to receive the

[0101] The stimulation device 26 preferably includes electronic circuitry and a power source, which is preferably In a preferred embodiment, it is provided within the device 10.

[0102] The stimulation device 26 preferably delivers the stimulation pulses as a pulse train, is repeated with a time break between them, where the break is the time for each pulse in the pulse train. It is constructed to extend the break between

[0103] FIG. 5B shows essentially the same embodiment as that of FIG. 5A, except that the internal control unit A unit 56, a remote control 28, and an external energy transmission device 34 are added. The internal control unit 56 is connected to the stimulation device by a power lead 56b. The control unit 57 controls the battery 70, the electrical switch 72, and the It may include other components as described in.

[0104] A reflux disease treatment device 10, according to one embodiment of the present invention, is shown in FIG. Alternatively, the reflux disease treatment device 10 may be formed as a generally oval shaped body. According to the embodiment, as shown in FIG. 6B, an egg-shaped or spherical shape with a depression in the middle is formed. The reflux disease treatment device 10 may also be formed as a body. In some embodiments, the periphery may be further configured as a slightly curved oval body, as shown in FIG. 6C. can be formed.

[0105] A reflux disease treatment device 10 according to another embodiment of the present invention may be provided as shown in FIG. 6D. The body may be formed as a generally spherical body, such as

[0106] As described above, the reflux treatment device 10 is secured in position above the esophagus of an upright patient. To achieve this, one embodiment of a reflux treatment, shown in FIG. The device includes a fixture 10d that is used as an attachment point for a doubling suture or stapler. The reflux treatment device 10 may be fixed to the loop or ridges with or without holes. The present invention may have other shapes that make it suitable for fixing.

[0107] FIG. 8 illustrates one embodiment of a reflux treatment device 10 that is adjustable by hydraulic means. 10e is an inlet through which hydraulic fluid can be injected to expand the device. Alternatively, in one embodiment, the reflux treatment device 10 may be configured such that the device is inserted into the esophagus, e.g., laparoscopically. Whereas a small size is advantageous at the beginning of the examination, a small size is advantageous at the time of surgery. In one such embodiment, the solid, liquid, or injects gas filling material into the inlet 10e, and the reflux treatment device 10 takes its final shape. It is possible to do so.

[0108] FIG. 9 illustrates a reflux treatment device 10 having recessed ridges 100 configured to be held by a surgical tool. 0f, which may be used, for example, when a reflux treatment device is implanted. It is sometimes used during surgery.

[0109] When the reflux disease treatment device 10 is generally spherical, it can penetrate the esophagus as a whole. The reflux disease treatment device 10 may be formed to include or partially include a The diameter D is preferably such that the device does not directly abut the esophageal wall when implanted. It is an internal diameter that encompasses at least a portion of the meatus and fundus.

[0110] The movement restriction device 10 restricts movement of the cardiac notch of the patient's stomach toward the patient's diaphragm. This prevents the cardia from sliding through the patient's diaphragmatic opening and into the patient's thoracic cavity. The device is positioned to maintain supportive pressure exerted by the patient's abdomen against the patient's cardiac sphincter. The vise 10 may be configured to be able to be placed in the holder 14.

[0111] Next, an engine, generally designated 28, which is incorporated in the device according to the invention will be described. The energy and operation system will be described with reference to FIGS.

[0112] The system 28 shown in FIG. 10 is an energy consuming component of a reflux disease treatment device. The embedded device is configured to supply energy to the embedded device via a power supply line 32. The device includes an internal energy source in the form of an energy transforming device 30. The transmission device 34 can be incorporated into the implanted energy-transforming device 30. A radio signal is transmitted to a receiver, which may be a single unit or a separate unit. The implanted energy-transforming device 30 is equipped with a wireless remote control device that transmits signals. The energy from the power supply is converted into electrical energy and provided via the power supply line 32. Provide.

[0113] System 28 of FIG. 10 is shown in more generalized block diagram form in FIG. 11, Therein, the patient's skin 36, generally indicated by a vertical line, is to the right of the line. It separates the interior of 29 from the exterior to the left of the line.

[0114] FIG. 11 illustrates a movement restriction device 10, a power supply line 32 connected to the device 10, and An energy conversion device 30 for providing power, and an external energy transmission device 34 FIG. 1 shows a simplified block diagram of a system for implementing the present invention.

[0115] FIG. 12 shows an electrical switch 3 which can also be operated by polarized energy. A reversal device in the form of 8 is implanted in the patient 29 to reverse the device 10. 12 shows an embodiment of the present invention similar to that of FIG. 11, except that an external energy The wireless remote control of the transmission device 34 transmits a wireless signal that transmits the polarization energy; The implanted energy transforming device 30 converts the wireless polarization energy into an electrical switch 38. The polarity of the current is determined by the embedded energy conversion device. When switched by device 30, electrical switch 38 operates in a manner implemented by device 10. Reverses the function performed.

[0116] FIG. 13 shows a reflux disease treatment device 10 implanted in a patient's body for regulating the reflux disease treatment device 10. The operating device 40 is disposed between the implanted energy transforming device 30 and the device 10. 11, except that the operation is performed in the same manner as in FIG. The actuating device may be in the form of a motor 40, such as an electric servo motor. The power supply to the power source 40 is provided by the embedded energy conversion device 30. At this time, a remote control device of the external energy transmission device 34 transmits a wireless signal to the embedded The received signal is transmitted to a receiver of the energy transforming device 30.

[0117] FIG. 14 shows an assembly 4 with a motor / pump unit 78, which also includes an operating device. 11, except that the fluid reservoir 46 is implanted within the patient's body. 1 shows an embodiment of the same invention as in FIG. 1, in which the device 10 is hydraulically operated. That is, hydraulic fluid is pumped from a fluid tank 46 through a conduit 44 by a motor / pump unit 44. 8 to the device 10 to operate the device, and the motor / pump unit 44 The hydraulic fluid is pumped from the device 10 to the fluid tank 46 so that the device 10 is returned to the starting position. Back. The implanted energy transforming device 30 converts the wireless energy into an electric current, e.g. The power is converted into a polar current and sent to the motor / pump unit 44 via the power supply line 50. Supplying power.

[0118] Instead of a hydraulically operated movement restriction device 10, the operating device is a pneumatic operating device. In this case, compressed air is available for regulation and the flow is controlled. The body tank is replaced with an air chamber and the fluid is replaced with air.

[0119] In all of these embodiments, the energy-transforming device 30 is a A rechargeable accumulator, such as a battery or capacitor, that is charged by to provide energy for the energy consuming parts of the device.

[0120] The external energy transmission device 34 is preferably a wireless device and is connected to the outside of the human body. A remote control device for controlling the device 10 may be provided.

[0121] Such control devices could be implemented not only by wireless remote control devices, but also by the patient's hands, perhaps Indirectly, for example, any implanted part of the hand that comes into contact with a button placed under the skin A dynamic control device may be provided.

[0122] FIG. 15 shows an external energy transmission device 34, in this case a liquid crystal display, with a wireless remote control. The device comprises a pneumatically operated device 10 and an embedded energy conversion device 30, Also shown are a hydraulic tank 52, a motor / pump unit 44, and a hydraulic valve switching device. The present invention further includes 54 forms of reversal devices, all of which are implanted within the patient's body. This shows one embodiment of the invention. Of course, hydraulic operation can be achieved by simply changing the pump operation direction. The remote control can be easily implemented by means of an external air valve, and thus hydraulic valves can be omitted. It may be a device separate from or integrated into the energy transmission. The motor of the motor / pump unit 44 is an electric motor. In response to a control signal from the wireless remote control of the energy transmission device 34, the embedded The energy transforming device 30 converts energy from the energy carried by the control signal. The motor / pump unit 44 is driven by the energy of the The pump unit 44 distributes hydraulic fluid between the hydraulic fluid tank 52 and the device 10. The remote control of the external energy transmission device 34 controls the hydraulic valve switching device 54. The fluid is then pumped by a motor / pump unit 44 to operate the device 10. The fluid is pumped from the tank 52 into the device 10 in one direction and the fluid moves to the starting position. from the device 10 to the hydraulic fluid tank 52 by the motor / pump unit 44 to return the The flow direction of the hydraulic fluid is switched between the opposite direction and the return direction.

[0123] FIG. 16 illustrates an external energy delivery device 34, an accumulator 58, and a capacitor An internal control unit 56 controlled by a wireless remote control device 60 is also implanted within the patient. 16 shows an embodiment of the present invention similar to that of FIG. 15, except that an internal control unit is included. The unit 56 is embedded in an accumulator 58 that supplies energy to the device 10. The external energy conversion device 30 receives electrical energy from the storage. In response to a control signal from a wireless remote control of the energy transmission device 34, The internal control unit 56 releases electrical energy from the accumulator 58 and supplies the power line The energy released through the power lines 62 and 64 is converted into 6, a capacitor 60 for stabilizing the current, a power line 68, and a power line 64 The electric energy from the implanted energy conversion device 30 is directly converted via the , operate device 10.

[0124] The internal control unit is preferably programmable from outside the patient's body. In an embodiment, the patient is provided with a pre-programmed time schedule or possible physical parameters. The device may be configured to adjust the stomach according to input from a computer or any sensor that senses a functional parameter of the device. The programming for adjusting the device 10 to stretch is done in an internal control unit. .

[0125] According to an alternative, the capacitor 60 may be omitted from the embodiment of FIG. Alternatively, accumulator 58 may be omitted in this embodiment.

[0126] FIG. 17 illustrates a battery 70 for providing energy for the operation of device 10 and a An electrical switch 72 for switching the operation of the device 10 is also implanted within the patient. 10, except that an electric switch 7 is shown. 2 is powered by the energy provided by the embedded energy conversion device 30. For operation of the device 10 from an off mode, when the battery 70 is not in use, The battery 70 supplies energy and is switched to the on mode.

[0127] FIG. 18 shows an internal configuration controllable by a wireless remote control device of the external energy transmission device 34. 16, except that the external control unit 56 is also implanted in the patient's body. In this embodiment, an electrical switch 72 is provided to switch on the embedded energy The wireless remote control device is operated by the energy provided by the conversion device 30. Prevented from controlling the internal control unit 56, battery not in use, off From the mode, the remote control device controls the internal control unit 56 to operate the device 10. The battery 70 is allowed to discharge electrical energy in order to switch to standby mode. Can be replaced.

[0128] FIG. 19 shows an embodiment in which an accumulator 58 is used in place of a battery 70 and is connected to an embedded 17, except that the components are interconnected in a different way. In this embodiment, the accumulator 58 is an embedded energy conversion The energy from the device 30 is stored. In response to a control signal from the control device, the internal control unit 56 activates the electrical switch 7 2 to switch the accumulator 58 from the off mode when it is not in use to the accumulator 58 supplies energy for operation of device 10, switching it to the on mode.

[0129] FIG. 20 shows that a battery 70 is also implanted in the patient's body, and the implanted components are 18, except that the two are interconnected in a manner similar to that of FIG. The response of the external energy transmission device 34 to a control signal from a wireless remote control device In response, the internal control unit 56 sends energy to operate the electrical switch 72. The accumulator 58 is controlled to transition from an off mode, in which the battery 70 is not in use, to a The power supply 70 is switched to an on mode, which provides electrical energy for the operation of the device 10. can.

[0130] Alternatively, the electrical switch 72 may be adapted to receive the energy provided by the accumulator 58. The wireless remote control controls the battery 70 that supplies the electrical energy. The wireless remote control device is prevented from being in use and is in off mode. 10 is allowed to control the battery 70 that supplies electrical energy for the operation of the It can be switched to standby mode.

[0131] It is understood that the switch should be interpreted in its broadest embodiment. This may be due to the fact that the FPGA or DA converter or other electronic components Alternatively, the circuitry can be powered on and off, preferably from outside the patient's body, or or an internal control unit.

[0132] FIG. 21 shows a motor 40, a mechanical reversing device in the form of a gear box 74, and a gear An internal control unit 56 for controlling the box 74 is also implanted in the patient's body. 17, except that the internal control unit 5 6 controls the gear box 74 to reverse the functions performed by the device 10 (Mechanically operated). It is even easier to switch the motor's direction electronically.

[0133] FIG. 22 shows a schematic diagram of a 3D printer, except that the embedded components are interconnected in a different way. 20 shows an embodiment of the present invention. Thus, in this case, the internal control The unit 56 includes an accumulator 58, optionally a capacitor, which operates an electrical switch 72. When the electric switch 7 is switched to the ON mode, the electric power is supplied from the battery 70. When the internal control unit 56 is in the on mode, the internal control unit 56 controls the operation of the device 10. It is permitted to control the battery 70 to supply or not supply energy. do.

[0134] Figure 23 shows the embedded components of the device to achieve various communication options. The figure shows an outline of possible combinations of devices that may be contemplated. Basically, the device 10, the internal control unit 56, a motor or pump unit 44, and an external wireless remote control device. As already explained above, there is an external energy transmission device 34 that includes a wireless remote control. The control device sends control signals which are received by the internal control unit 56 to control various aspects of the device. Control various embedded components.

[0135] Sensing a patient's physical parameters, such as contraction waves in the esophagus that indicate when the patient is eating A feedback device, preferably in the form of a sensor 76, is provided to the patient's body to inform the patient of the The internal control unit 56 or an external energy transmission device The external wireless remote control of the sensor 34 may be configured to receive the signal from the device 1 in response to the signal from the sensor 76. By combining the transceiver with the sensor 76, the sensed The information about the body parameters acquired can be transmitted to an external wireless remote control device. The remote control device may include a signal transmitter or transceiver, and the internal control unit 5 6 may comprise a signal receiver or transceiver. Alternatively, it may comprise a wireless remote control device. The device may include a signal receiver or transceiver, and the internal control unit 56 may receive the signal. The above-mentioned transceiver, transmitter and The device 10 includes a sensor 12 and a receiver 14 for transmitting information or data related to the device 10 from inside the patient's body to outside the patient's body. It can be used to believe.

[0136] Alternatively, a sensor 76 may be positioned to sense a functional parameter of the device 10. It is also possible.

[0137] A motor / pump unit 44 and a power supply for the motor / pump unit 44 When the battery 70 for the battery 70 is implanted, the battery 70 may include a It can be equipped with a transceiver to transmit information to the When energy is charged into the battery or accumulator, Corresponding feedback information is transmitted and the energy supply is switched accordingly.

[0138] FIG. 24 illustrates an alternative embodiment in which the device 10 is regulated from outside the patient's body. The stem 28 is connected to a movement restriction device 1 connected to a battery 70 via a subcutaneous switch 80. 0. Thus, adjustment of the device 10 is accomplished by manually pressing a subcutaneous switch. This is performed non-invasively, thereby turning the operation of the device 10 on and off. The embodiments shown are simplified and may be implemented using the internal control unit or the control circuitry disclosed in this application. Additional components can be added to the system, such as other parts that are It will be understood that.

[0139] FIG. 25 illustrates a system 28 including a movement restriction device 10 in fluid communication with a hydraulic fluid tank 52. 1 shows an alternative embodiment comprising a hydraulic transducer connected to the device 10. This is done by manually crimping the ink.

[0140] Another embodiment of a system incorporated in a device according to the present invention is a system for transmitting information from inside a patient's body. and transmitting to the outside of the subject at least one functional parameter or parameters of the mobility restriction device or apparatus. or provides feedback information related to a patient's physical parameters, thereby improving the performance of the device. Equipped with a feedback device to optimize performance.

[0141] One favorable functional parameter of the device is the ability to charge an internal energy source. It is correlated with energy transfer.

[0142] FIG. 26 shows how precise amounts of energy are delivered to the patient's body, with the skin 36 shown as a vertical line. 1 shows a schematic of an arrangement for feeding the system 28 embedded in the The restriction device 10 is similarly positioned within the patient's body, preferably just beneath the patient's skin 36. In general, the implanted energy transforming device 30 is connected to the The implanted energy transforming device 30 may be placed in the abdominal cavity, the thoracic cavity, or in the fascia (e.g., the abdominal wall). The implant may be placed intradermally, subcutaneously, or in any other suitable location. The energy transforming device 30 is implanted in the patient's body near the implanted energy transforming device 30. The external energy transmission device 34 is disposed on the outside of the skin 36. The external energy source 34a is configured to receive wireless energy E transmitted from the external energy source 34a. .

[0143] As is well known in the art, the wireless energy E is generally an external energy A primary coil disposed in the energy source 34a and an embedded energy conversion device 30 Any suitable transcutaneous energy device, such as a device comprising an adjacent secondary coil disposed When a current is sent to the primary coil, e.g. For example, an energy storage device or accumulator such as a battery or a capacitor. After storing the incoming energy in the capacitor, the energy is transferred in the form of a voltage to the travel limiting device. The secondary coil may be used to manipulate the power supply. However, the present invention is not limited to the general The present invention is not limited to any particular energy transfer technology, but includes any TET device or energy storage device. Storage devices, and any type of wireless energy may be used.

[0144] The amount of energy received inside the body of the device is used by the device. Therefore, the terminology used for the device is The amount of energy transferred is understood to include the energy stored by the As described above, the external energy source 34a is controlled based on the determined energy balance. The reverse can be adjusted using the local control unit 34b to deliver the correct amount of energy. An internal control unit 56 connected to the blood flow treatment device 10 is used to perform energy balance. and the amount of energy required. Thus, the internal control unit 56 measures some characteristic of r10 that is in any way required for proper operation of device 10 A suitable sensor or similar, not shown, reflects the amount of energy required to be The patient's temperature may be adjusted to receive various measurements obtained by the following: The current state can also be sensed using suitable measuring devices or sensors, so that Thus, parameters reflecting the patient's condition are obtained. The parameters may be the current state of the device 10, such as power consumption, operating mode, and temperature. , and also related to the patient's condition as reflected, for example, by temperature, blood pressure, heart rate, and respiration. It can be said that.

[0145] Additionally, an energy storage device or accumulator 58 stores the received energy The embedded energy converter stores the energy for later use in the device 10. Alternatively or additionally, any required Properties of such accumulators that reflect the amount of energy they contain can also be measured. The accumulator can be replaced by a battery and the measured characteristics are voltage, temperature, The battery status may be related to the current state of the battery, such as temperature, etc. To provide the device 10 with sufficient power and to avoid overheating, the embedded energy By receiving the right amount of energy from the conversion device 30, all That is, the charge amount should not be too small or too large. It is clearly understood that the accumulator may be a capacitor having the corresponding characteristics. .

[0146] For example, the battery characteristics may be periodically measured to determine the current state of the battery and then the result may be The results may be stored as status information in suitable storage means within the internal control unit 56. Therefore, whenever a new measurement is made, the stored battery status is updated accordingly. In this way, the battery status can be updated to reflect the correct amount of energy. By transmitting the keep.

[0147] Thus, the internal control unit 56 controls the above-mentioned sensors or the measuring device, or the patient, or the energy storage device, if used; or any combination of these measurements to determine the energy balance and and / or the amount of energy currently required (energy per unit time or energy storage) The internal control unit 56 is configured to determine an internal signal A control signal reflecting the determined amount of energy required is also coupled to the transmitter 82 to an external The control unit 34b is configured to transmit an external signal to a receiver 34c. The amount of energy transmitted from the external energy source 34a is then determined based on the received control. The control signal can be adjusted in response to the control signal.

[0148] Alternatively, the sensor measurements can be sent directly to an external control unit 34b, which In this case, the energy balance and / or the amount of energy currently required is calculated using an external control unit. unit 34b, and thus the above-mentioned The function is integrated in the external control unit 34b. In that case, the internal control unit 56 , and the sensor measurement results are sent to an external signal receiver 34c and an external control It is then fed directly to an internal signal transmitter 82 which transmits it to unit 34b. The amount of energy currently needed and supported is calculated based on the results of these sensor measurements. This can be determined by the control unit 34b.

[0149] Therefore, the solution of the present invention can be used to measure, for example, the amount of energy, the energy difference, or the device. Regarding the rate of energy received compared to the rate of energy used by the It is based on actual energy usage compared to the energy received, so it is much easier to use than previous solutions. It employs feedback of information indicating the energy required, which is more efficient than conventional methods. The device 10 may use the received energy for consumption or as an energy storage device. It can be used to store energy in a chair or similar. Different parameters are used where relevant and necessary, and then the actual energy It is used as a tool to determine the energy balance.

[0150] However, such parameters may be implemented internally to specifically operate the device. Sometimes it is intrinsically necessary for an action.

[0151] The internal signal transmitter 82 and the external signal receiver 34c receive radio signals, IR (infrared) signals, or implemented as a separate unit using suitable signaling means such as ultrasonic signals. Alternatively, the internal signal transmitter 82 and the external signal receiver 34c may have essentially the same transmission using transmission techniques to transmit control signals in the opposite direction relative to the energy transfer. 3, the energy conversion device 30 and the external energy source 34a are integrated into the The control signal may be modulated in frequency, phase, or amplitude.

[0152] In conclusion, the energy supply arrangement shown in FIG. 26 basically consists of the following: The energy balance is first determined by the internal control unit 56. A control signal reflecting the amount of energy required is also generated by the internal control unit 56. The control signal is then transmitted from the internal signal transmitter 82 to the external signal receiver 34c. , the energy balance may instead be controlled by an external control unit 34b depending on the implementation, as described above. In this case, the control signals may carry the measurements from the various sensors. The amount of energy emitted from the external energy source 34a can then be calculated, e.g. For example, in response to a received control signal, based on a determined energy balance, This process can be regulated by an external control unit 34b. This may be repeated intermittently at specific intervals during the energy transfer, or may be performed more or less continuously during the energy transfer. This can be done.

[0153] The amount of energy transferred is generally determined by the voltage, current, amplitude, wave frequency, and power. By adjusting various transmission parameters of the external energy source 34a, such as the pulse characteristics, It can be adjusted by.

[0154] The electrical current is then supplied to an electrically operable reflux disease treatment device implanted in the patient's body. A method is provided for controlling the transmission of wireless energy E to a patient. The energy is transmitted from an external energy source located outside the patient's body and then placed inside the patient's body. The internal energy receiver receives the energy, while the external energy receiver receives the energy The device 10 is connected to the device 10 to directly or indirectly supply internal energy. between the energy received by the receiver and the energy used by the device 10 The energy balance is determined. Then, the transmission of wireless energy E from an external energy source is is controlled based on the determined energy balance.

[0155] Wireless communication is provided to an electrically operable movement restriction device 10 implanted within a patient's body. A system for controlling the delivery of energy is provided. The system is disposed external to the patient. The energy is delivered from an external energy source located inside the patient's body to an implanted energy The wireless energy E received by the wireless conversion device is transmitted to the embedded Energy conversion devices convert the energy they receive into energy that can be used directly or indirectly. The system is connected to a device 10. The system is connected to a device 10. Determine the energy balance between the energy taken in and the energy used by the device 10. Based on the determined energy balance, the transmission of wireless energy E from an external energy source is The device is further configured to control the transmission.

[0156] The functional parameters of the device are the energy transfer to charge the internal energy source. Correlated with.

[0157] In yet another alternative embodiment, the external energy source is controlled from outside the patient's body and is electromagnetically The emitted electromagnetic wireless energy is used to operate the device 10. can be.

[0158] In other embodiments, the external energy source is controlled from outside the patient's body and is a non-magnetic energy and the emitted non-magnetic wireless energy is used to operate the device 10.

[0159] Those skilled in the art will appreciate that the above various embodiments according to FIGS. 14 to 26 can be implemented in many different ways. For example, you can manipulate the polarization energy. The electrical switch 38 constructed as described above may be incorporated into any of the embodiments of FIGS. It is possible, and a hydraulic valve switching device 54 can be incorporated into the embodiment of FIG. A gear box 74 may be incorporated into the embodiment of FIG. Note that can simply mean an electronic circuit or component. .

[0160] Wireless energy transmission for operating a movement restriction device 10, enabling non-invasive surgery It is understood that the device 10 can also be operated by wireless binding energy. It will be understood that such an example is shown in FIG. 26, where an external switch 84 Power lines 86 and 88 are used to regulate the external energy source 34a and the device 10. The external control unit 34 is interconnected with an operating device such as an electric motor for operating the actuator. b controls the operation of the external switch to effect appropriate operation of the device 10.

[0161] 28-31 show a hydraulic or pneumatic powered movement restriction device according to the present invention. 1 shows a more detailed block diagram of four different methods of providing pneumatic power.

[0162] FIG. 28 shows a system for treating reflux disease as described above. The system includes the device 10, an independent regulating tank 46, a one-way pump 44, and a substitute A replacement valve 54 is further provided.

[0163] FIG. 29 shows the device 10 and the fluid reservoir 46. The walls of the regulation reservoir are moved or or by changing the size of the regulating tank in other different ways, a device without a valve The tank wall can be moved to allow the fluid to pass freely at any time. do.

[0164] FIG. 30 shows the device 10, a bidirectional pump 44, and an adjustment tank 46.

[0165] FIG. 31 shows a reversing servo system with a first closing system controlling a second closing system. The servo system includes a regulation tank 46 and a servo The servo tank 90 is connected to a travel limit device via a mechanical interconnection 94. The device 10 has an expandable / accessible cavity. The cavity of the device 10 preferably includes a larger adjustable reservoir 92 in fluid communication with the device 10. The servomotor expands or contracts by supplying hydraulic fluid from the cavity. The tank 90 is filled with a compressible gas that can be compressed and expanded under the control of the tank 90.

[0166] The servo tank 90 may be part of the device itself.

[0167] In one embodiment, the regulation reservoir is placed under the patient's skin and its outer surface is exposed using a finger. This reflux disease treatment system is shown in FIG. In FIG. 31, a flexible subcutaneous regulation reservoir 46 has an inflated shape with a conduit 48. The servo tank is shown connected to the servo tank 90. The link 90 is contained within the flexible movement restriction device 10. In the state shown in FIG. The servo tank 90 contains a minimum amount of fluid, with most of the fluid going into the adjustment tank 46. The mechanical interconnection between the servo tank 90 and the device 10 allows the device The outer surface of 10 shrinks, i.e., occupies a volume less than its maximum volume. This maximum volume is In the figure, this is indicated by a dashed line.

[0168] FIG. 32 shows a state in which a user, such as a patient having a device implanted, applies pressure to the adjustment tank 46. The fluid contained therein is forced through conduit 48 into servo tank 90, where it is 90 shows the state in which the bellows shape expands in the longitudinal direction. This allows the device 10 to occupy a maximum volume, thereby reducing the area of ​​the stomach wall (as shown) that the device contacts. The image is enlarged so that the part (not shown) is stretched.

[0169] The conditioning tank 46 preferably includes means 46a for retaining its shape after compression. This means, which is diagrammatically shown in the figure, thus ensures that the adjustment tank is kept in a constant state even when the user releases the adjustment tank. This will hold the device 10 in the extended position. It essentially acts as an on / off switch for the reflux disease treatment system.

[0170] Next, referring to Figs. 33 and 34, alternative embodiments for hydraulic or pneumatic operation are described. The block diagram shown in FIG. 33 is a block diagram of the second closing system. The first system includes a regulation tank 46 and a servo The servo tank 90 is connected to a larger The tank 92 is mechanically controlled and has an expandable / contractable cavity. The motion restriction device 10 includes a larger adjustable reservoir 92 in fluid communication with the device 10. The hydraulic fluid is controlled by a larger adjustable tank 92 supplied from

[0171] An example of this embodiment will now be described with reference to FIG. In the embodiment, the regulation tank is placed under the skin of the patient and its outer surface is pressed with a finger. The adjustment tank 46 has an inflated shape using a conduit 48. The first closed system shown in FIG. In systems 46, 48, and 90, the servo tank 90 contains the minimum amount of fluid and provides the majority of the flow. The body is in conditioning tank 46.

[0172] The servo tank 90 has a bellows shape in this example, but the diameter is 10 mm larger than that of the servo tank 9 0. The tank is mechanically connected to a larger adjustable tank 92, which is larger than the tank size 90. A larger adjustable reservoir 92 is in fluid communication with the device 10. presses the regulation tank 46, which causes fluid to flow from the regulation tank 46 to the servo tank 90 The expansion of the servo tank 90 allows a larger volume of fluid to flow through it when it is pushed out. This means that the liquid is delivered to the device 10 from a larger adjustable reservoir 92. In this reverse servo, a small amount of the adjustment tank is compressed with a larger force, and the unit volume Reduces impact force and creates a larger total area of ​​movement.

[0173] As in the previous embodiment described above with reference to Figures 32a-c, the adjustment tank The block 46 preferably includes means 46a for retaining its shape after compression. The means shown thus extends even when the user releases the adjustment tank. This will hold the device 10 in a fixed position. In this way, the adjustment tank is essentially Additionally, it acts as an on / off switch for the reflux disease treatment system.

[0174] FIG. 35 is a flow chart of the steps performed when implanting a device according to the present invention. First, in step 102, an opening is formed in the abdominal wall. At 104, an area around the stomach is incised. Then, at step 106, a small At least one migration restriction device is placed in contact with the stomach wall, particularly the fundus wall. Then, in step 108, the stomach wall is sutured.

[0175] FIG. 36 illustrates a method for restoring the arrangement of the cardia and fundus of a stomach, comprising: The device 200 having a hiatal hernia 202 is inserted into the esophagus 24 of a patient suffering from a hiatal hernia. In this case, it is assumed that the catheter is placed below the diaphragm 18. A portion of the esophagus 24 and the fundus 16 passes through the hiatus 18a to a location above the diaphragm 18. It's moving.

[0176] FIG. 37 shows that in a subsequent step, a member having a larger cross-sectional area than the device 200 is 203 is shown being released from the device 200. The member 203 is attached to the cardia 1. 4. This is because the member 203 is configured to have a cross-sectional area larger than that of the opening of the The instrument 200 can then be pushed distally to expand laterally. The cardia 14 and fundus 16, or a portion of the fundus 16, that is not properly positioned over the septum 18 18. The catheter 18 then slides back into place beneath the diaphragm 18 through the hiatus 18a.

[0177] FIG. 38 illustrates an alternative method to that shown in FIG. 37, which is one embodiment of the present invention. In many aspects, this view is similar to FIG. 37. In FIG. 38, the device 200 is 2, release the balloon member 204 at the end 205 of the device 200 located at the lower portion of the stomach 206. The balloon member 204 is used to press the device 200 against the lower wall portion of the stomach 207. The cardia 14 and the fundus 16 or a part of the fundus 16 slide through the hiatus 18a and reach the diaphragm 18. It is configured to be in a certain position below.

[0178] FIG. 39 illustrates yet another alternative method according to an embodiment of the present invention. Again, this The figure is in many respects similar to Figure 37. However, in Figure 39, the method is This involves attaching the member 203 to the wall of the stomach 207 by means of fasteners 208. As shown in FIG. 1, the cardia 14 and a part of the stomach wall 16 or the fundus 16 slide under the diaphragm 18. Push the instrument distally into the

[0179] FIG. 40 shows the fundus 16 and cardia 14 being pushed through the hiatus 18a by the instrument 200. It is later shown how it is placed in a position below the diaphragm 18.

[0180] Figure 41 shows a further step in the method. The fundus 16 and cardia 14 are then inserted into the diaphragm. After being pushed into the correct position under the membrane 18, the wall of the fundus 16a is secured to the lower part of the esophagus 24. This is the proximal portion of the instrument 200 that may include a suture or stapler 210. This is accomplished by using member 209 at 205. The fastener is positioned above the diaphragm 18. The gastric catheter 14 prevents the cardia 14 and fundus 16 from moving toward the gastric cavity.

[0181] Other methods of the present invention are briefly described below.

[0182] A method for treating reflux disease in a patient includes providing a reflux disease treatment system according to the present invention in the patient's body. The method includes the step of embedding.

[0183] The method of using the system for treating reflux disease according to the present invention is to prevent reflux after surgery. The method includes adjusting the device to stop the

[0184] A method for surgically placing a movement restriction device in a patient according to the present invention includes: The method includes the steps of: incising the abdominal wall to form an opening; incising an area around the stomach; placing a wall-mounted movement restriction device; and suturing the stomach wall. Includes.

[0185] Methods for adjusting devices using an externally controlled reflux disease treatment system after surgery The method includes filling a volume attached to a portion of the stomach wall and administering the device from outside the patient's body. and adjusting the flow rate to affect reflux in the patient.

[0186] The method of using the migration restriction device includes placing a first portion of the device in the stomach. Filling the volume of the first portion of the wall and placing the second portion of the device. and adjusting the device from outside the patient's body to fill a volume of the second portion of the stomach wall. and affecting reflux in the patient.

[0187] A method of treating reflux disease in a patient includes inserting a needle or tubular device into the abdominal portion of the patient's body. and filling the patient's abdomen with gas using a needle or tubular device, thereby The step of enlarging the abdominal cavity and inserting at least two laparoscopic trocars into the patient's body. and inserting the camera through one of the laparoscopic trocars into the patient's abdomen. and inserting at least one incision tool into the at least two laparoscopic trocars. and inserting the catheter through one of the catheters and incising at least a portion of the patient's stomach in the intended placement area. and placing a migration restriction device according to the present invention on the fundus wall. into the fundus wall of the stomach and suturing the stomach wall to itself to hold the device in place. A step of suturing the fundus of the stomach toward the lower part of the esophagus, and a step of sliding the cardia to the diaphragm. and preventing the passage of the catheter through the membrane into the thoracic cavity. The use of such methods and devices is highly effective and reduces tissue damage and disorganization. A method for treating reflux esophagitis that does not cause complications such as unwanted migration of tissue into the tissue is realized.

[0188] The filling body of the device is configured to be pushed or pulled through a trocar for laparoscopic applications. The trocar may have a diameter smaller than the relaxed diameter of the body. The filling body may have an outer wall and a hollow gas-filled interior that allows the body to pass through a trocar. Alternatively, the filling body may have an outer wall and a hollow, fluid-filled interior that allows the body to pass through a trocar. In this latter case, the fluid may be a gel. It can be inserted into the local area and assembled into one integral piece inside the patient's body. The filling body may further include a plurality of portions that can be inserted into the trocar to allow the filling body to pass through the trocar. The filling body consists of an outer wall and a hollow cavity that is filled with a fluid or gel after insertion into the patient's body. The device may include a compressed internal portion, which is adapted to compress the fluid after insertion into the patient's body through the inlet. The packing may further include an inlet that can be used to fill the packing body with

[0189] The filler body of the device comprises a resilient compressible material that allows the filler body to be passed through the trocar. The filling material has a Shore hardness of less than 25, and even less than 15. It can be made from materials.

[0190] The filling body may also have an outer wall that is substantially ball-shaped. Constructed to be used to push or pull a filler through a trocar for endoscopic examination. The surgical instrument may also include at least one holding device configured to hold a surgical instrument. The device may be configured to hold an extension of the device that is configured to be held by the tool. The retention device may also retain a suture or band inserted through the retention device. The retention device may also be arranged at least partially inside the outer wall of the packing body. The filling body of the device is preferably designed to prevent intestinal obstruction in the event that the balls enter the stomach as a complication. Preferably, the catheter may have a size larger than the intestinal outlet from the stomach to avoid The body has a minimum outer diameter of between 30 mm and 40 mm or more. The minimum circumference is between 1.5 mm and 150 mm.

[0191] Device for treating reflux disease, system including device for treating reflux disease The present invention relates to a method for detecting a cellular component comprising: It is realized that these may be varied within the scope of the appended claims. Although different features are described in specific embodiments, these may be used in different configurations as appropriate. It will be appreciated that combinations of hydraulic controls are possible. 4A-B, which is described in conjunction with the device configurations of FIGS. This can also be applied to the device configuration of B.

[0192] The implanted reflux treatment device is held securely in place within the stomach wall into which it is invaginated. For this purpose, reflux treatment devices are used to fix the invagination. One or more through-holes configured to accept a suture or stapler One such embodiment is shown in FIG. The reflux treatment device 10 is mounted on a protruding flange-like projection on the reflux treatment device. In this embodiment, the row of holes is the length of the reflux treatment device. It extends along the hand axis.

[0193] FIG. 43 shows how sutures 314 are provided to pass through the stomach wall 12a and through the holes 10i. In this manner, the reflux treatment device is appropriately positioned within a pouch formed by the stomach wall. The rod is fixed in place and therefore will not slip off.

[0194] In FIG. 42, multiple holes are shown, which may be used to improve fixation of the reflux treatment device 10. It will be appreciated that one hole is sufficient.

[0195] FIG. 44 shows a reflux treatment device with an inlet 10h. The reflux treatment device includes: It is invaginated into the stomach wall and the inlet 10h is connected to a tube or the like from the patient's abdomen. are available for

[0196] FIG. 45 shows an invaginated reflux treatment device, where instead of an inlet, a fixed A fixed tube 10g extends into the patient's abdomen.

[0197] FIG. 46 is similar to FIG. 44, but shows the stomach wall between the inlet 10h and the reflux treatment device 10. It also shows that a connecting tube 10g is formed in a tunnel shape inside.

[0198] It has been shown that the shape of the reflux treatment device can take a variety of forms. It will be appreciated that a variety of device materials may also be used. The reflux treatment device is a Parylene-coated, polytetrafluoroethylene (PTFE ) coating, polyurethane coating, or combination of such coatings It is preferable to provide a coating such as a multi-layer coating. The layered or multi-layered coating improves the properties of the reflux treatment device, such as wear resistance.

[0199] In one embodiment, the reflux treatment device comprises an inflatable device expandable to an expanded state. In this case, the inflatable device includes an inlet for fluid and is connected to a gastroscopic instrument. Next, this embodiment will be described in detail with reference to Figures 47a to 47d. explain.

[0200] The inflatable reflux treatment device in its unexpanded state is shown in Figure 47a. This is essentially A balloon-like, deflated device 10 with an inlet 10h. In this state, the inflatable The functional device has a diameter of at most a few millimeters, and therefore the device is 1B, a gastroscope tubular device 600 is used to pass the patient's esophagus into the stomach. The instrument can be inserted into the outer sleeve 600a and into the outer sleeve 600b. The inner sleeve 600b has a distal end that is movable in the direction of the distal end of the inner sleeve. A cutter in the form of a cutting edge 615 is provided, as will be described in more detail below. In addition, it can be used to cut open a hole in the stomach wall.

[0201] When the device reaches the stomach wall (see FIG. 47c), the inner sleeve is inserted into the outer sleeve. The inner sleeve is then moved forward from the position to contact the stomach wall 12a. a hole is made in the stomach wall, and then the reflux treatment device 10 is inserted through the hole. (See Figure 47d). To push the reflux treatment device through this hole, insert a piston into the instrument. The device can thus be equipped with an inner slot 602 as shown in FIG. Reverse contraction from the reeve position to the outer position of the inner sleeve as shown in Figure 47d. It further comprises a piston 602 configured to push the fluid treatment device 10 .

[0202] To protect the reflux treatment device 10 in the contracted state from the cutting edge 615 of the inner sleeve A protective sleeve (not shown) may be further provided around the reflux treatment device. Cut.

[0203] Next, regarding the intraluminal method of indenting the reflux treatment device 10 on the outside of the stomach wall 12a, FIG. First, an instrument 600, preferably a gastroscopic instrument, is inserted into the patient's mouth. (See Figure 48a) The instrument delivers either fluid or a device into the patient's stomach. The instrument 600 includes injection devices 601, 602 for injecting into the instrument. The control unit 606 is further configured to control. The unit 606 includes one or more steering devices, and in the embodiment shown in the figure takes the form of two joysticks 603 and two control buttons 604. An image taken by a camera (not shown) located at the outer end of member 607 A display 605 is provided for displaying the image (see Fig. 48e-i). It may be assisted by a source (not shown).

[0204] The instrument is further inserted into the patient's esophagus and into the patient's stomach (see FIG. 48b). An instrument 600 is used to make a hole 12b in the wall of the stomach 12. For this purpose, the instrument may be, for example For example, one may attach a stent at its distal end by the method described above with reference to Figs. 47a-d. The cutter includes a number of cutters 615. These cutters may, of course, be tubular. They are designed in various ways, such as a toothed drum cutter that rotates around the central axis of the tool. The instrument 600 is hollow to provide space for the reflux treatment device 10 in a deflated state. vinegar.

[0205] After the stomach wall is cut and punctured, the distal end of the instrument 600 is inserted so that it terminates outside the stomach wall 12a. 48c, which shows a side view of the stomach 12. Also shown in FIG. 48d is a cross-sectional view through the stomach of FIG. 48c taken along the line Vd-Vd. The deflated reflux treatment device 10 is then inserted into the abdomen.

[0206] The device 600 creates a "pocket" or "pouch" on the outside of the stomach 12 around the hole 12b in the stomach wall. Such an apparatus and method for forming a pouch will now be described. do.

[0207] 48e-i show the formation of a pouch of material in the stomach wall 12a in which the reflux treatment device is placed. A gastroscope or laparoscope is used to insert the reflux treatment device 10 into the stomach wall 12a of a patient. 6 shows a laparoscopic instrument, generally designated 600, as described above with reference to FIGS. The device may have the features described herein, and may include an elongated member 607 having a proximal end and a distal end. The elongated member 607 has a diameter smaller than the diameter of the patient's esophagus and is flexible. This allows the flexible elongated member 607 to move from its distal end to the patient's throat and esophagus. 1, into the stomach 12 and into the stomach wall 12a.

[0208] A stomach penetration device or cutter 615 may be introduced through the hole in elongated member 607. 3, a distal end of the elongated member 607 is inserted into the stomach wall 12a to form a hole in the stomach wall 12a. The stomach penetration device 615 is located at the end of the stomach in order to prevent further tissue damage inside the body. In addition, the stomach penetration device 615 can be retracted after the fundus wall 12a has been penetrated. The instrument can be configured to be a thin piece proximal to the penetrating device 615. It further comprises a special holding device 609 provided on the elongate member 607 .

[0209] The elongated member is configured to expand after the elongated member penetrates the stomach wall 12a. The reflux treatment device 610 may further include a movable member 611 configured to hold the reflux treatment device 610. The expandable member 611 aids in the formation of a cavity or pouch formed therein. 07 may include an inflatable circular balloon disposed about the periphery of the distal end portion thereof.

[0210] The method steps involved in invaginating a reflux treatment device are now described in detail. After the device 600 is inserted into the stomach 12, the stomach penetration device 615 is brought into contact with the stomach wall 12a (FIG. 48). A stomach penetration device or cutter 615 is then brought in to create a hole 1 in the stomach wall. 2b, and then at least the expandable member 611 is passed through the hole 12b in the stomach wall. The holding device 609 is in a holding state in this step, where it expands radially to It forms an essentially circular abutment surface against the stomach wall 12a (see FIG. 48f). Thus, inserting the stomach penetration device 615 and the expandable member 611 into the hole 12a in the stomach wall , is limited to the position shown in FIG. 48f.

[0211] The expandable member 611 is then expanded. In this case, the expandable member may be a balloon or includes a similar structure into which air, or other fluid, is injected.

[0212] Then, as shown by the arrow in FIG. 48g, a thin film with an expandable member 611 is inserted. When a portion of the elongate member 607 is retracted proximally, a special retention device 609 The stomach wall 612 is drawn into the basket-like structure that is formed.

[0213] A suturing or stapling device 608 is connected to the elongated member 607. The suturing or stapling member may be provided as a separate device. , a suture configured to close the cavity or pouch using an intergastric suture or stapler 14 Or it has a stapler end 613 .

[0214] In another step, shown in FIG. 48h, the inflatable reflux treatment device 10 is The reflux treatment device 10 is then placed in a deflated state within the bucket-like structure. or to an expanded state (see FIG. 48i). Such expansion of the reflux treatment device 10 This can be done by injecting a fluid or gel into the deflated reflux treatment device. This can be done by injecting a material that can be hardened, thereby forming a rigid device 10. Therefore, the reflux treatment device shown in Figures 48h and 48i can be The chair 10 is a basket-like structure formed by a fluid or gel or stomach wall 12a. It may refer to a balloon-like device which is then filled with a material that is simply injected into the

[0215] The fluid used to fill the reflux treatment device 10 may be an inflatable disposable fluid, such as saline. The fluid may be any suitable fluid suitable for filling the vice 10. Now, if this fluid is one that is being converted to a solid state, the fluid is It is also possible to use polyurethane.

[0216] To minimize or eliminate leakage, the fluid is isotonic, i.e. It has the same osmolality as human body fluids. Other methods to prevent diffusion include the use of iodine molecules. The first step is to provide a fluid containing macromolecules.

[0217] The gastric suture or stapler is preferably inserted between the stomach and the stomach to promote in-growth of human tissue. The device is configured to contact the wall and has a fixed portion having a structure such as a net-like structure, and is applied to the wall of the stomach. Ensures long-term placement of the attached reflux treatment device.

[0218] After the inflatable device 10 is partially or completely inflated, the reflux treatment device 10 48h and 48i) and insert the device 600 into the hole 12b. The hole is then closed in a suitable manner, such as with instrument 600. The device is removed from 600 and is in an inflated or expanded state by a portion of the patient's stomach wall outside the stomach wall. In one or more of the above steps, the expandable device 10 is preferably can use a gastroscopic instrument to inflate the stomach with gas.

[0219] The reflux treatment device 10 described above with reference to Figs. 48a-i includes an inflatable reflux treatment device. It is described as a therapeutic device that compresses and can be inserted into a gastroscopic instrument. The elastic reflux treatment device has elasticity that can be expanded to an expanded state after being released from the device. It will be appreciated that this may also be possible.

[0220] A device for treating reflux may have the additional function of treating obesity. In one such embodiment, the reflux treatment device provides a volumetric capacity to fill the stomach, thereby providing satiety. One embodiment that has this function is shown in FIG. , in which a combined reflux treatment device and bariatric treatment device is administered while the patient is in an upright position. A chair 310 is positioned adjacent to and at least partially above the cardia 14 of the patient. The wall is invaginated and secured to the cardia region 14c by a fastener such as a suture or stapler 22. For example, directly or indirectly attached to the diaphragm or associated muscles. Alternatively, the esophagus may be fixed directly above and near the angle of His or directly into the esophagus. In this alternative embodiment, the combined device 310 However, when it was implanted, it was placed in a position that hit the stomach wall at the fundus, and the cardia slid into the thoracic cavity. 2. Fill the volume above the cardiac region 14c between the cardiac and diaphragm muscles so as not to allow ingress of This prevents reflux disease.

[0221] Such a combination device 310 may include electronic circuits and / or an energy source and It can be used to hold and / or store hydraulic fluid. The smaller expandable device area is distributed, which sometimes results in stretched areas. This allows for a change in the area of ​​the stomach wall, avoiding the possibility of a more permanent stretching effect on the stomach wall. Even mechanical stretching can be used in several areas.

[0222] Combination reflux treatment device-stretching device. An alternative embodiment is shown in Figure 50. In an embodiment, the volume of the inflatable reflux treatment device 310 is preferably one or more These chambers can be in fluid communication with the smaller inflatable device or chamber 10b. is configured to communicate with fluid or air moving between the chambers.

[0223] Thus, the large chamber 310, with its main volume being the reflux treatment device, is adapted to accommodate food The one or more small chambers are configured to reduce the size of the cavity and treat reflux disease. , configured to function as an inflatable device for treating obesity, the main chamber including a small This allows fluid or air to enter the small chambers, causing a stretching effect on the stomach wall, which can lead to obesity. The present invention is configured to further treat

[0224] FIG. 51 illustrates a volume filling device being invaginated into the middle or lower part of the stomach and the upper part of the patient's stomach. or in one embodiment using a combination with a stretching device that is invaginated into the fundus. These two devices work to treat obesity.

[0225] The volume filling device 399 fills the stomach volume to produce satiety. This stretches the stomach wall, which stimulates endogenous signaling that stretches tissue and produces satiety. This mimics the stretching effect of filling the stomach with food. 51 shows an adjustable volume filling device invaginated within the stomach wall of a patient's stomach 312. In addition, an adjustable enlarger device with the above-mentioned features is shown. The vise 350 is invaginated into the patient's fundus wall. It is preferably substantially larger than device 350 .

[0226] The volume filling device 399 and the stretching device 350 are configured to treat reflux. In one embodiment, the volume filling device and the stretching device are The cardia 14 slides upward through the opening of the hiatus 18a and comes into a position above the diaphragm 18. The device is positioned to prevent this.

[0227] The volume filling device 399 and the stretching device 350 are provided with a pump 354. The pumps 354 are in fluid communication with each other via a first fluid tube 352, which is connected to the The power supply line 356 is configured to supply energy to the pump 350. The energy transforming device 330 is under control of the 0 is also connected to a sensor 319 located in the patient's esophagus so that food intake can be detected. is.

[0228] The reflux treatment device 10 and the stretching device 350 are also preferably connected to a first fluid channel. The fluids communicate with each other via a second fluid tube 358, which has a smaller cross-sectional area than the tube 352. It communicates with.

[0229] The operation of this arrangement is as follows: A volumetric filling device 399 is The endoscopic device functions like a prosthesis, that is, it reduces the size of the food cavity of the stomach 12 of the patient. The stretching device 350 then pumps the fluid from the volume filling device 10 using a pump 354. to the stretching device 350, the fundus wall is stretched, This creates a feeling of fullness in the patient. For example, if food intake is detected using sensor 319, In this case, fluid is automatically pumped into the enlargement device 350 to increase satiety, This limits food intake.

[0230] When fluid is injected into the stretching device 350, the internal pressure therein is increased to provide reflux treatment. This pressure difference causes the stretching device 350 to Fluid flow in a second, preferably smaller tube 358 to a reflux treatment device 399 The flow rate is determined, among other things, by the pressure difference and the cross-sectional area of ​​the second tube 358. The dimensions of the second tube are determined by the volume filling device 399 and the stretching device 35. The pressure in the device 350 stretches the fluid and returns to equilibrium 3 hours after injection into the device 350. It is preferable that the amount of food consumed is determined so as to produce a feeling of satiety.

[0231] In this embodiment, the function of the second tube 358 is to extract the volume from the stretching device 350. The function of this is to return the fluid to the load filling device 399. It is possible to implement this with pump 354 as well, and then omit second tube 358. It will be understood that

[0232] Method for placing a reflux treatment device inside the stomach wall: Methods and devices for placement inside the stomach wall are described.

[0233] The invagination device illustrated in Figs. 52a-l, generally designated 630, is similar to that of Fig. 48a. An elongated tubular portion similar to elongated member 607 described above with reference to This can then be connected to the control unit 606 (FIG. 4). 8a). The invagination device 630 preferably further comprises an elongated, perforated suction portion 634. The suction portion 634 is provided with a number of small holes 636 through which the tube member 6 Air is drawn in by applying suction to the inside of the 32. This suction effect is generally It is used to form a "pocket" or "pouch" in a portion of the stomach wall, as shown do.

[0234] In other words, when the tip of the suction portion 634 is pressed against the stomach wall 12a (see FIG. 52a), A small recess is formed therein. When the suction portion 634 is further pressed against the stomach wall 12a ( 52b), a larger depression is formed. Due to the suction effect, the suction portion 634 of the invagination device 630 is attached to the suction portion 634. Further pressure on the stomach wall 12a (see FIG. 52c) creates a deeper recess, and finally The entire suction portion 634 is embedded within the recess (see FIG. 18d).

[0235] The rim of the recess is now fixed using the fixing element 638 and the suction part is removed from the instrument. (See FIG. 52e). The compressed elastic reflux treatment device 10 is then For example, the electrode 14 is inserted into the recess 12 by the method described above with reference to FIG. 47d (FIG. 5 2f). This compressed reflux treatment device is then expanded to its final shape. (See Figure 52g), and the pouch is then secured by suturing or stapling using the fixation elements. It is sealed (see Figure 52h).

[0236] All alternatives described above with reference to Figures 1 to 51 may be combined with Figures 52a to 52l. The embodiment described above, in which the reflux treatment device is invaginated inside the stomach wall, This is also applicable to the embodiment.

[0237] 53a-c show the reflux treatment device according to whether it is placed inside or outside the stomach wall. Depending on the circumstances, the stomach wall may be placed on the outside or inside of the stomach wall to form an invagination in the stomach wall. The device uses a vacuum to draw a portion of the stomach wall into the cup of the device. do.

[0238] Illustrates how the reflux treatment device 10 is invaginated into the stomach wall using a gastroscopic instrument. Using a gastroscopic instrument, the reflux treatment device was inserted into the esophagus as shown in Figure 1A. It can be placed on the outside of the stomach wall or inside the stomach as shown in FIG. 2A. In the latter case, an instrument is used to cut the stomach wall from the inside of the stomach.

[0239] It will be appreciated that abdominal surgery techniques may also be used. Next, with reference to Figs. Such a method is described below. In FIG. 54, an incision 380 is made in the abdomen of a patient. FIG. 55 shows how the stomach can be accessed by the device 3 in the patient's abdomen. 81. All of the described instruments and methods Thus, for example, a reflux treatment device may be selected and configured for this purpose. The chair can be placed on the outside of the stomach as shown in Figure 1A or inside the stomach as shown in Figure 2A. In the latter case, an incision is made in the stomach wall. [Explanation of symbols]

[0240] 10. Movement Restriction Devices 13 Main unit 15 Exterior 16 Fundus wall 16a Exterior wall 18 Diaphragm 20 Thoracic cavity 22a, 22b, 22c Sutures or staplers.

Claims

1. Gastroscope for providing invagination of a medical device within the gastric fundus wall of a human patient to treat reflux disease An apparatus, the apparatus comprising: (i) an elongate member (607) having a proximal end and a distal end, said elongate member being adapted to be attached to a patient; The flexible elongated portion has a diameter smaller than the diameter of the esophagus and is flexible, whereby The distal end of the flexible elongated member is then introduced through the patient's throat and esophagus into the stomach, and the distal end of the flexible elongated member is then introduced through the patient's throat and esophagus into the stomach, an elongate member (607) that allows the (ii) penetrating the fundus wall to create a hole in the fundus wall and directing the elongated member through the hole; a blade disposed at a distal end on a retractable sleeve disposed within the elongated member for allowing insertion of the blade into the distal end of the elongated member; A steerable stomach penetration device having a tip (615); (iii) moving the elongated member proximally through the hole after introduction of the elongated member through the hole; a penetrating device provided on the elongated member proximal to the penetrating device for preventing the penetrating device from an expandable specialized holding device, the specialized holding device comprising: a balloon extendable at least radially from the elongated member to abut the outer side of the balloon against the fundus wall; an expandable special retention device including a loop-shaped expandable member (611); (iv) a support member on the elongate member proximal to the expandable special retention device; A forming device comprising a basket-like structure, the inside of the forming device being placed against the fundus wall. a forming device; and (v) inserting the medical device through the hole into the fundus wall to the outside of the fundus wall; Insertion device for invagination into the bottom wall A gastroscopic instrument comprising:

2. The forming device, together with the special retaining device, forms the fundus wall into a cup-like shape. the special holding device is retractable relative to the forming device, 2. The method of claim 1, wherein the stomach wall is pulled against a forming device to form the cup-shaped portion of the stomach. The device described in.

3. The apparatus further includes a suturing device (613), the suturing device (613) being adapted to suturing the stomach. The open end of the cup-shaped portion of the fundus wall is sutured so that at least a portion of the fundus wall is sewn.

3. An apparatus according to claim 1 or 2 adapted to create an enclosed space.

4. The suturing device according to claim 3, further comprising a plurality of sutures for simultaneously suturing two or more stitches. Mounted equipment.

5. The suturing device is adapted to sew the medical device into the hole in the fundus wall by the insertion device.

4. The method of claim 3, further comprising the steps of:

3. The apparatus according to claim 3.

6. 1. A system for use in a surgical procedure to limit movement of a cardiac notch in a patient, comprising: The system provides for invagination of a medical device within the fundus wall of a human patient to treat reflux disease. a gastroscopic instrument, the instrument comprising: (i) an elongate member (607) having a proximal end and a distal end, said elongate member being adapted to be attached to a patient; The flexible elongated portion has a diameter smaller than the diameter of the esophagus and is flexible, whereby The distal end of the flexible elongated member is then introduced through the patient's throat and esophagus into the stomach, and the distal end of the flexible elongated member is then introduced through the patient's throat and esophagus into the stomach, an elongate member (607) that allows the (ii) penetrating the fundus wall to create a hole in the fundus wall and directing the elongated member through the hole; a blade disposed at a distal end on a retractable sleeve disposed within the elongated member for allowing insertion of the blade into the distal end of the elongated member; A steerable stomach penetration device having a tip (615); (iii) moving the elongated member proximally through the hole after introduction of the elongated member through the hole; a penetrating device provided on the elongated member proximal to the penetrating device for preventing the penetrating device from an expandable specialized holding device, the specialized holding device comprising: a balloon extendable at least radially from the elongated member to abut the outer side of the balloon against the fundus wall; an expandable special retention device including a loop-shaped expandable member (611); (iv) a support member on the elongate member proximal to the expandable special retention device; A forming device comprising a basket-like structure, the inside of the forming device being placed against the fundus wall. a forming device; and (v) inserting the medical device through the hole into the fundus wall to the outside of the fundus wall; Insertion device for invagination into the bottom wall The system comprises: The medical device is inserted by the insertion device and invaginated into the patient's stomach fundus wall from outside the patient's body. Vice The medical device further comprises a biocompatible body that is placed against the fundus wall of the stomach, The medical device, when implanted and functional, has a circumference of at least 15 mm, and The device has a volume small enough that the chair can be completely penetrated by the fundus wall from the outside, thereby A system that limits movement of the patient's cardiac notch.

7. The forming device, together with the special retaining device, forms the fundus wall into a cup-like shape. the special holding device is retractable relative to the forming device, 7. The method of claim 6, further comprising: pulling the stomach wall against a forming device to form the cup-shaped portion of the stomach. The system described in

8. The apparatus further includes a suturing device (613), the suturing device (613) being adapted to suturing the stomach. The open end of the cup-shaped portion of the fundus wall is sutured so that at least a portion of the fundus wall is sewn.

8. A system according to claim 6 or 7 adapted to generate an enclosed space.

9. The suturing device according to claim 8, further comprising a plurality of sutures for simultaneously suturing two or more stitches. The system described.

10. The suturing device is adapted to sew the medical device into the hole in the fundus wall by the insertion device.

4. The method of claim 3, further comprising the steps of:

9. The system described in claim 8.

11. The medical device rests against the exterior of the stomach wall without restricting food passage through the esophagus. A system according to any one of claims 6 to 10 adapted to:

12. The medical device is adapted to rest against the exterior of the stomach wall without encircling the esophagus. The system according to any one of claims 6 to 11.

13. 1. A medical device for use in a surgical procedure to limit migration of a patient's cardiac notch, comprising: The medical device comprises: The instrument is inserted into the patient's body by an insertion device; penetrated by the patient's fundus wall; When implanted and functioning, it is primarily positioned on the left side of the esophagus and the medical device is adapted to a biocompatible body placed against the fundus wall of the stomach; When implanted and functioning, it has a circumference of at least 15 mm; has a volume of at least 125 mm3; The medical device is adapted to be indirectly or directly attached to the esophagus, thereby The cardiac notch is restricted in its movement, allowing the cardiac cavity to slide through the patient's diaphragmatic opening and into the patient's thoracic cavity. and maintaining supportive pressure on the patient's cardiac sphincter exerted from the patient's abdomen, A medical device that treats reflux disease.

14. The medical device rests against the exterior of the stomach wall without restricting food passage through the esophagus. The medical device of claim 13 adapted to

15. The medical device is adapted to rest against the exterior of the stomach wall without encircling the esophagus. The medical device of claim 13 or 14.

Images