RU2285499C2 - Device for test reduction of space of stomach - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: device can be used for treatment of obesity. Device has holding envelope and working balloon disposed in the envelope. Balloon is made of elastic material to have back valve and connection member for making dismountable connection with pipeline. Pipeline is connected with excess pressure source. Working balloon has wall which is made to be destroyed by stomach medium, or part of wall to be destroyed by stomach medium either plug built in the wall to be destroyed by stomach medium. Thickness of plug exceeds thickness of wall at lest 1,2 times. Area of part of wall, which part is made for being destroyed by stomach medium, equals at least to 1/20 area of balloon's surface. Maximal size of back valve onto surface of balloon doesn't exceed 2/3 diameter of balloon.

EFFECT: preliminary reveal of reaction to treatment.

4 cl, 4 dwg

Description

The invention relates to medical equipment, in particular to surgical instruments, and can be used to treat obesity.

Devices for reducing the volume of the stomach are known.

For example, a device is known that contains a working cylinder of elastic material connected to a pipeline connected to an overpressure source (DE 3206118, 11/03/1983).

The known device has a complex structure and requires special skills when installing it, because the pipeline runs along the diameter of the cavity of the working cylinder.

Another example is a device for reducing the volume of the stomach, containing a retaining shell and a working balloon made of elastic material with a non-return valve and a connecting element for detachable connection with a pipeline connected to an overpressure source (see EP 0137878, 04.24.1985 )

The known device is installed in the stomach, where the working balloon is inflated until the retaining shell ruptures. The balloon is in the stomach for about six months, during which a person loses weight, usually by 5-25 kg.

The disadvantage of the device according to EP 0137878 is that some patients tolerate a working balloon installed in the stomach very poorly. They experience constant nausea and vomiting and cannot adapt to the balloon, which must be removed after 1-2 weeks (instead of the prescribed 6 months). In addition, despite the decrease in the volume of the stomach, some patients lose weight poorly, and some do not lose weight at all (they are about 25%). Therefore, before installing a working balloon in the stomach, it is necessary to know the patient’s response to the balloon.

Closer to this invention can be considered the design described in JP 63277063, 11/15/1988 and made in the form of a working balloon with an internal coating for the destruction of gastric juice.

The disadvantage of the device according to JP 63277063, 11/15/1988, is that for its extraction, a puncture of the working cylinder with a temperature probe is necessary.

The present invention is aimed at solving the problem of creating a test device to reduce the volume of the stomach, capable of having the simplest design possible to have the optimal interaction of the walls of the working balloon with adjacent tissues and to detect the reaction of the patient's body to the proposed treatment, including reducing the volume of the stomach with a drug having a similar effect on this patient.

Accordingly, the technical result of the invention is a technical effect, objectively manifested during its use and consisting in obtaining and implementing the listed properties.

The invention is expressed in the aggregate essential features, in which a device for test reduction of the volume of the stomach, containing a working balloon made of elastic material, differs from the closest analogue in that the working balloon is placed in a holding shell and is equipped with a check valve and a connecting element for detachable connection to the pipeline, associated with a source of excess pressure, while the working cylinder has a wall made for destruction by the gastric environment, or a section of the wall made for destruction by the gastric environment, or a plug built into the wall made for destruction by the gastric medium, wherein the thickness of the plug is not less than 1.2 than the wall thickness, the area of the wall portion made for destruction by the gastric medium is at least 1/20 of the surface area cylinder, and the maximum size of the check valve on the surface of the cylinder does not exceed 2/3 of the diameter of the cylinder.

The above set of essential features is sufficient to achieve the technical result of the invention in all cases to which the requested amount of legal protection applies.

In particular cases of its implementation or use, the device may contain a retaining shell made for destruction by pressure of the working balloon, and / or for destruction by the gastric environment; contain an elastic conductor made for insertion into the pipeline, as well as a working cylinder equipped with a radiopaque mark.

The causal relationship of these features with the technical result of the invention is that the holding shell and the working cylinder made of a flexible material made of elastic material with a non-return valve and with a connecting element for detachable connection with the pipeline connected to the source of overpressure, allow you to have a device when it is inserted into the stomach, the minimum dimensions and, therefore, facilitate both its introduction through the esophagus and the subsequent inflation of the working balloon, produced by the pressure of the liquid supplied from the source of excess pressure through the pipeline.

The presence in the working balloon of a wall made for destruction by the gastric medium, or of a wall section made for destruction by the gastric medium, or of a plug built into the wall of the plug made to destroy the gastric medium, allows the balloon to be installed in the stomach for a relatively short period of time, while the thickness of the plug does not less than 1.2 times the wall thickness of the working cylinder and the area of the discharge section of the wall of the working cylinder, at least 1/20 of its surface area, allow you to choose the right pair meters of the working cylinder and its duration.

The maximum size of the check valve, not exceeding 2/3 of its diameter on the surface of the balloon, virtually eliminates intestinal obstruction when the working balloon exits naturally.

The indicated ratio of the sizes of the elements of the device is obtained as a result of studies of working cylinders made of elastic materials allowed for use in medicine.

These studies have shown the sufficiency of the above ratios, not only to conclude that it is possible to achieve the technical result of the invention in the particular case, which is illustrated by the following examples, but also in other cases of the invention.

So, when the wall thickness of the silicone working balloon was 0.5 mm and the plug made on the basis of latex was 0.6 mm thick, the residence time of the working balloon in the stomach was 3.5 weeks, after which the balloon successfully emerged naturally. At the exit of the balloon, a non-return valve with a maximum size of 3.8 mm and a diameter of 10 mm did not create the prerequisites for the occurrence of intestinal obstruction.

The invention is illustrated by drawings, where Fig. 1 shows a general view of a device for test reduction of the volume of the stomach, which is prepared for surgery and has a collapsed working balloon connected to a source of overpressure placed in a retaining shell, Fig. 2 - a working balloon placed in the stomach having a wall made for destruction by the gastric environment, Fig. 3 shows a working balloon with a wall section made for destruction by the gastric medium, and Fig. 4 shows a working balloon with a plug integrated in the wall, venous for destruction by the gastric environment.

The device for test reduction of the volume of the stomach contains a holding shell 1 and placed in the holding shell 1 working cylinder 2 of elastic material with a check valve 3 and with a connecting element 4 for detachable connection with the pipeline 5. The pipe 5 is connected to a source of overpressure 6. Working balloon 2 has a wall made for destruction by the gastric environment, or a section 7 of the wall made for destruction by the gastric medium, or a plug 8 built into the wall, made to destroy the gastric medium food. The thickness of the plug 8 is not less than 1.2 greater than the wall thickness of the balloon 2. The area of the portion 7 of the wall of the balloon 2, made for destruction by the gastric environment, is at least 1/20 of the surface area of the balloon 2, and the maximum size of the check valve 3 on the surface of the balloon 2 does not exceed 2/3 of the diameter of the cylinder 2.

In special cases of its implementation or use, the device may contain a holding shell 1, made for pressure destruction of the working balloon 2, and / or for destruction by the gastric environment, an elastic conductor made for insertion into the pipeline 5, as well as a working balloon 2, equipped with a radiopaque mark.

A device for test reduction of the volume of the stomach is installed under endoscopic control and under complete anesthesia. Depending on the preferences of the doctor, the patient may lie on his back or on his left side. The holding shell 1 is lubricated with a special gel. A medical dye, methylene blue, which is needed for timely recognition of leaks, is introduced into the container of water intended for inflating the working balloon 2, if the working balloon 2 is depressurized for any reason. After a preliminary gastroscopy, i.e. examination of the esophagus and stomach for the presence of diseases that may be a contraindication for the installation of the device, it is introduced into the lumen 9 of the stomach 10 through the esophagus 11. To the pipe 5 installed in the connecting element 4 (which can be made in the form of a tube drawn into the check valve 3 or in the form of an inlet of the check valve 3), a source of overpressure 12, for example a syringe, is connected, after which, under the control of vision, the working balloon 2 begins to inflate by supplying fluid through the check valve 3. erzhivayuschaya shell 1 is located in the working cylinder 2 is broken, and the balloon 2 is released. When the working cylinder 2 is filled to the required volume (500 ml), the pipeline 5 is pulled out of the connecting element 4, and the check valve 3 closes. The working balloon 2 becomes a free ball in the lumen 9 of the stomach 10. The pipeline 5 and the gastroscope are removed from the esophagus 11 of the patient and the installation procedure for the device ends.

The working balloon 2 fills a significant part of the volume of the stomach 10 and, therefore, the amount of food that a person can eat is reduced. In addition, the working balloon 2 stretches the stomach walls, which leads to irritation of satiety receptors and the early appearance of a feeling of satiety.

The working balloon 2 should be in the stomach for about 1 month. During this period, the gastric environment acts on its wall, made for destruction by the gastric medium, or on the wall section 7, made to be destroyed by the gastric medium, or on the plug 8 built into the wall, made to destroy the gastric medium. Since the thickness of the plug 8 is not less than 1.2 greater than the wall thickness of the cylinder 2, and the area of the portion 7 of the wall of the cylinder 2 is not less than 1/20 of the surface area of the cylinder 2, this destruction does not occur immediately and may have a mode specified by the corresponding wall design or by performing the discharge section 7 of the wall, or by performing a plug 8 integrated in the wall.

As a result of the influence of the gastric environment on the listed elements, the working balloon 2 or its elements are destroyed. The remnants of the working cylinder 2 independently come out naturally, while the implementation of the check valve 3 with a maximum size on the surface of the cylinder 2, not exceeding 2/3 of the diameter of the cylinder 2, eliminates the occurrence of obstruction.

Claims (4)

1. A device for test reduction of the volume of the stomach, containing a working balloon made of elastic material, characterized in that the working balloon is placed in a holding shell and is equipped with a check valve and a connecting element for detachable connection with the pipeline associated with the source of overpressure, while the working balloon has a wall made for destruction by the gastric environment, or a portion of the wall made for destruction by the gastric medium, or a plug built into the wall made to destroy the stomach full-time medium, and the stub thickness is not less than 1.2 times the wall thickness, the area of the wall section made for destruction by the gastric medium is not less than 1/20 of the cylinder surface area, and the maximum size of the check valve on the cylinder surface does not exceed 2/3 diameter of the cylinder. 2. The device according to claim 1, characterized in that the retaining shell is made for destruction by the pressure of the working balloon and / or for destruction by the gastric environment. 3. The device according to claim 1, characterized in that it contains an elastic conductor made for insertion into the pipeline. 4. The device according to claim 1, characterized in that the working cylinder is equipped with a radiopaque mark.

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