CN103330608A - A balloon device for weight loss and symptom relief - Google Patents

Abstract

The invention relates to an air bag comprising two chambers, which is placed in a hollow organ of the body, preferably in the stomach, for the purpose of reducing weight or symptoms. In a preferred embodiment, the chambers of the air bag can be controlled by mechanical feedback, which is achieved by a computer and a pump. The pumping between the chambers is controllable, which can pump fluid from one chamber to another, even against pressure gradients. The chambers of the air bag are adjustable, in a preferred embodiment, by controlling the flow of fluid between the chambers.

Description

A balloon device for weight loss and symptom relief

technical field

The invention belongs to the field of medical equipment, and in particular relates to a balloon device for weight loss and symptom relief.

Background technique

Over the years, obesity has become one of the major health problems plaguing Europe and America. In China, the incidence of obesity is also increasing. According to the report of the World Health Organization, the incidence of obesity in the whole country is less than 5%, but the incidence of obesity in some large cities is already higher than 20%. At present, China's obesity patients are mainly concentrated in big cities with fast food culture and internationalization. Due to China's large population base, one-fifth of the world's 1 billion obese patients come from China.

Statistics from the Chinese Ministry of Health show that compared with 30 years ago, the average Chinese boy of about 6 years old living in the city has grown by 2.5 inches in height and 6.6 pounds in weight. The most famous child health scholar in China, Professor Ji Chengye declared: China has entered the era of obesity, and the growth rate of the number of obese people is alarming. Many obese patients will die prematurely from diabetes and cardiovascular diseases caused by obesity. Hence, the market growth rate and potential for obesity treatment is high. Surgery and medication, while they can help treat obesity, are often not really successful. And there are a large number of obese patients who are unwilling to accept surgical treatment. If gastric emptying can be delayed by non-surgical methods, the goal of reducing weight in obese patients can be achieved. The devices and methods involved in the present invention are based on such a concept.

Contents of the invention

The present invention is concerned with two problems, obesity and symptoms due to delayed gastric emptying. Obesity is common, with more than 30 percent of the population in the United States being overweight. Obesity can lead to other diseases such as diabetes and heart failure. There are many treatments for obesity. From diet therapy to various medications, endoscopic placement of an air bag or balloon in the stomach, and surgery. The solution for placing an inflatable air bag in the stomach is based on the idea that due to the volume taken up by the air bag the patient feels full and therefore eats less. A commercially available product is the Spatz Adjustable Balloon (a US product, see www.spatzmedical.com for details). However, the disadvantage of the Spatz balloon is that it must be adjusted through a connecting tube to the balloon. In other words, it requires an extra measure to do so.

Other patients, obese or not, may suffer from various visceral symptoms. For example such symptoms may be associated with delayed gastric emptying caused by chronic diabetes or other diseases. Often the cause is unknown, in which case it is called functional dyspepsia. Therefore, it is of great interest to develop a device that can reduce this symptom.

Technical scheme of the present invention comprises:

A balloon device for weight loss, including an air bag placed in a hollow organ in the body, the air bag is composed of two chambers and a connecting tube, liquid or gas can flow between the two chambers; the air bag An outlet/inlet port is provided as an opening for liquid or gas to enter and exit the balloon device; the volume of the air bag is variable as the liquid or gas flows in and out of the air bag cavity through the port.

Preferably, the capacity of the air bag and its chamber can be controlled; the chamber is equipped with sensors, through which the relevant data can be measured from one or more parts of the hollow organs of the body; it also includes a valve arranged on the connecting pipe, which is received by the computer according to The data measured by the sensor controls the opening of the valve to control the flow of liquid or gas between the chambers of the air bag.

Preferably, a non-collapsible channel runs through the entire air bag, and a flap or pump is arranged in the channel, so that liquid or gas can be discharged from any direction.

Preferably, the chamber contains means to prevent sliding within the organ system.

Preferably, the device to prevent slippage within the organ system is a dilator or volume control device.

Preferably, the air bag is made of elastic material, and can also be made of hard material, in other words, it can not expand too much, so as to avoid damage to the stomach or small intestine.

Preferably, the sensors comprise sensors for measuring deformation and force, sensors for measuring electrical impedance in the fluid.

Preferably, the sensors for measuring deformation and force are selected from ultrasonic crystals, pressure sensors, and the sensors for measuring electrical impedance in the fluid are strain gauges.

Preferably, the electronic components therein are charged by a replaceable rechargeable battery or by wireless transmission.

Preferably, the chamber contains means to prevent sliding within the organ system.

The present invention involves placing a balloon or air bag (referred to as an air bag in the remainder of this article) in the stomach. However, it is not a bag in the normal sense, it can have various shapes, the air bag contains one or more chambers, and the volume of each chamber can be regulated by changing mechanical variables, such as pressure, tension ( force) or strain (deformation). Therefore, each chamber has variable and controllable volume and shape. The tension depends roughly on the pressure and radius of the air pocket. Positive strain occurs during tension and negative strain occurs during compression. Strain is usually calculated as (deformed length minus reference length) divided by reference length.

WO2007/081304A2 describes a gastric band device whose inner diameter can be expanded by connecting a pump. Both external and internal devices can be used to adjust this part of the strap. The main difference between the present invention and the invention of WO2007/081304A2 is that the present invention is used inside the stomach instead of outside the stomach, and the present invention uses an air bag system instead of an external band adjustment.

Description of drawings

Figure 1 shows a preferred embodiment of an air bag system.

Figure 2 shows another preferred embodiment of an air bag system.

Figure 3 shows a third preferred embodiment of the air bag system.

Figure 4 shows a fourth preferred embodiment of an airbag system.

Explanation of reference numerals: 1-chamber A, 2-chamber B, 3-connecting pipe, 4-pump, 5-electronic equipment, 6-pressure sensor, 7-channel through air bag, 8-outlet/inlet port , 9-channel pump control device, 10-wire.

Detailed ways

The device is intended for use in obese patients in order to allow them to lose weight. When a doctor decides to use an air bag in a patient, he usually uses an endoscope to send the air bag to the stomach. For example, when an endoscope is inserted through the mouth and esophagus, the air bag will somehow attach to the endoscope and will enter the stomach with the endoscope. The air bag inserted into the stomach is connected to a catheter connected to a syringe outside the body. The doctor will inject an appropriate amount of liquid into the balloon through the catheter, then separate the catheter from the air bag, and take out the endoscope. Now the air bag device remains in the stomach . If the doctor must change the volume of the air bag or remove it, the doctor must reinsert the endoscope to connect the extracorporeal catheter to the air bag in the patient's stomach.

Preferred embodiments of the present invention are described below, and it should be understood that the preferred embodiments described here are only used to illustrate and explain the present invention, and are not intended to limit the present invention.

Figures 1-4 show some preferred embodiments. The present invention consists of an adjustable air bag system containing one or more chambers, which can have various shapes.

Figure 1 shows a preferred embodiment of a balloon system comprising a large chamber A placed in the stomach and another chamber B placed in the antrum or small intestine. The two chambers are connected by a hollow connecting pipe 3, and the distribution of liquid or gas volume between the two chambers (A and B) is controlled by a valve or pump 4. The pump control system can be used to extract liquid or gas from one chamber to another chamber, so as to adjust the capacity of the air bag. The connecting tube 3 is preferably made of a plastic material to ensure that it is not crushed, but the connecting tube may also consist of other materials. A small electronic device 5 is connected to pressure sensors 6 in both chambers, pressure sensors 6 are shown in chambers A,B. This setup can measure pressure to control the valve or pump, or the measured pressure can be wirelessly transmitted to an external recorder.

In a preferred embodiment, the air bag can be adjusted according to pressure, volume, strain or tension level during or after insertion into the body hollow organ of interest, even across different parts of the hollow system, such as a part in the stomach The other part is in the duodenum, or in several parts of the stomach such as the fundus and antrum. The preferred target organ is the stomach, but it is applicable to any hollow organ. The size of the airbag system must be adjusted to the size of the organ in which it is placed. In a preferred embodiment, the airbag contains sensors, electronics, a small computer and associated programming for determining the desired variables and controlling the distribution of fluid between the various chambers within the airbag. In one embodiment, the various chambers contain pressure sensors that measure the pressure within the chambers. Other sensors can measure the volume of each chamber, which is used to calculate radius, tension and strain. The volume, radius and circumference of an air bag and its different chambers can be measured in several ways. For example: 1) based on AS mode ultrasound, measuring distance by ultrasonic crystals placed at different intervals, 2) measuring the electrical resistance of the liquid inside the air pocket and the conductivity of the air pocket surface by electronic means, and 3) strain gauges. Of course there are other ways.

Figures 2-4 show several other examples of the preferred embodiment. In the embodiment of Fig. 2, the liquid or gas is distributed on the basis of fluid flow principles, which depend, for example, on the pressure and size of the two chambers and the resistance in the connecting pipe. In an embodiment with a pump and sensor, a battery provides power to the pump and sensor. The battery can be recharged wirelessly outside the body or through a catheter temporarily placed inside. Data on stress, tension, strain and other parameters such as flexure status are continuously or intermittently transmitted wirelessly to an external recorder. The operator can also change the computer's settings before, during or after air bag placement. This will allow control over many parameters, such as averaging tension over a time span. In one embodiment, the patient can give some control to the airbag system using a feedback system, eg based on symptoms experienced by the patient.

Figure 3 shows a third preferred embodiment of an air bag system, which consists of two chambers (1 and 2) and a connecting tube 3, between which liquid or gas can move freely. The connecting tube 3 is preferably made of plastic material to ensure that it does not collapse, but the conduit may also consist of other materials. The illustrated reference numeral 8 serves as an opening for liquid or gas to enter and exit the airbag system. It is closed as standard, but it can also be connected to a conduit for pressurization or removal of excess liquid or gas.

The fluid in the air bag can be liquid or gas. Instead of using a pump, the airbag system may contain its devices for changing the force and shape of the airbag system. For example, it could be artificial muscles that contract when charged, or controllable springs or actuators placed inside or on the surface of an air bag chamber. The shape of the air bag system is determined by its function. For example, with a pouch system with one chamber in the stomach and another in the duodenum, there should be a way to keep it from slipping through the pylorus and preventing it from sliding further down into the small intestine. Such a method could be a control system that ensures a minimum volume of the air pocket of the stomach, or making a dilatometer into the air pocket. In a similar way, the air bag system of the duodenum can also have a dilator to keep it at a minimum volume, thus ensuring that it does not slide into the stomach. As an example, the air pocket in the duodenum may be one or several long cylindrical shaped pockets that extend down to the small intestine. This would allow for a lot of capacity to fit inside the twelve-finger chamber. This function is very important and is preferred because the stomach is much larger than the duodenum and therefore the distribution of volume between the two organs must be taken into account.

A preferred embodiment, as shown in Figure 4, does not contain a fixed volume in the air bag system, but can receive liquid or gas from the surrounding or discharge it to the surrounding. Channel 7 of the bag. In the preferred embodiment of Figure 4, it consists of two chambers (1 and 2). In this particular embodiment, a non-collapsible channel 7 runs through the entire air bag system. This setup allows liquid or gas to pass from the stomach to the small intestine inside the balloon rather than outside. Because the channel may be blocked by food or other substances, there may be valves or pumps in the channel to discharge liquid or gas from any direction; one end of the channel opens to the stomach, and the other end opens to the small intestine, so it can be discharged. In a preferred embodiment, a valve system or channel pumping device 9 is placed in a non-collapsible channel within the balloon of the gastric pylorus.

In a preferred embodiment, the air bag system has one or more channels spanning through the air bag or one of its chambers. Figure 4 shows a preferred example of a passage through the bag. A channel may facilitate passage of food and liquid contents from one part of a body hollow organ to another, preferably the stomach into the intestinal tract, to prevent delayed gastric emptying. In order for the channels to not clot with the food contents, the system should include a channel cleaning mechanism such as a pump, or allow movement around the tube walls to aid in emptying the channels. Channels may also contain a valve to ensure flow occurs in one direction only.

Finally, it should be noted that: the above is only a preferred embodiment of the present invention, and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, for those skilled in the art, it still The technical solutions recorded in the foregoing embodiments may be modified, or some technical features thereof may be equivalently replaced. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included within the protection scope of the present invention.

Claims (10)

1. balloon apparatus that is used for fat-reducing, it is characterized in that: comprise that places the airbag in the hollow organ in the body, airbag is made up of two chambers and a connection tube, and liquid or gas can flow between two chambers; Airbag is provided with outlet/ingress port, as the opening of liquid or gas turnover balloon apparatus; When liquid or gas flowed outside the airbag intracavity by port, the capacity of airbag was variable.

2. device according to claim 1 is characterized in that: the capacity controllable system in airbag and its chamber; Be provided with sensor in the chamber, measure relevant data by sensor from one or more positions of health hollow organ; Also comprise the valve that is arranged at connection tube, by the unlatching of computer according to the measurement data by-pass valve control of the sensor that receives, with liquid or gas flow between the chamber of control airbag.

3. device according to claim 1 and 2, it is characterized in that: the passage that can not be subsided runs through whole airbag, and lobe or pump are set in the passage, thereby liquid or gas can be discharged from any one direction.

4. device according to claim 1 and 2 is characterized in that: chamber comprises prevent the device that slides in tract.

5. device according to claim 4 is characterized in that: prevent that the device that slides from being expansion instrument or capacity control device in tract.

6. according to claim 1 or 2 or 5 described devices, it is characterized in that: airbag is to be made by elastomeric material, also can be made by the harder material of quality, and in other words it can within reasonly be expanded, thereby avoids damaging stomach or small intestinal.

7. according to claim 1 or 2 or 5 described devices, it is characterized in that: sensor comprises the sensor for the sensor of measuring distortion and power, measurement fluid electrical impedance.

8. according to the device of claim 7, it is characterized in that: the sensor that is used for measurement distortion and power is selected from ultrasonic crystal, pressure transducer, and the sensor of measuring electrical impedance in the fluid is strain gauge.

9. according to the device of claim 1 or 2 or 5 or 8, it is characterized in that: electronic building brick wherein charges by replaceable rechargeable battery charging or by Wireless transmission mode.

10. device according to claim 3 is characterized in that: chamber comprises prevent the device that slides in tract.

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