CN107126307B - Novel connection and release method and structure of intragastric balloon system - Google Patents

Abstract

The utility model provides a novel connection and release structure of sacculus system in swallow type stomach is provided with self-closing structure on the sacculus, the distal end of pipe with self-closing structure detachably links to each other, the pipe distal end is provided with the gasbag, the gasbag is inflated the back and is inflated, and the external diameter increases, makes pipe and sacculus relatively fixed, the gasbag is retracted after being deflated, then the gasbag external diameter reduces, pipe and self-closing structure separation. The novel connection and release mode of this application not only simple structure, the volume is less, and the patient of being convenient for swallows, and pipe and sacculus firm in connection before carrying the filler moreover, easy operation, but easy separation after carrying finishes.

Description

Novel connection and release method and structure of intragastric balloon system

Technical Field

The present application relates to intragastric balloon systems for the treatment of obesity, and in particular to a novel method and structure for connecting and releasing intragastric balloon systems.

Background

Worldwide, over the past 20 years, the incidence of obesity, including adult obesity, senile obesity, and juvenile obesity, has risen, and in individual countries, such as the middle east and mexico, more than 35% of people suffer from obesity, and if overweight people with BMI between 25-30 are added, up to 60% of these areas are overweight or obese. In China, the incidence of obesity is more than 10%, and is higher if the incidence is measured by the abdominal circumference of Asian people with the characteristic of central obesity. More recently, it has been reported that in the northwest and northeast provinces, the incidence of adult obesity has exceeded 30%, and that in addition to overweight people with a BMI of 24-28, there are over 50% of adult weight abnormalities. It is conservatively estimated that 35% of the Chinese population (about 5 hundred million people) is overweight or meets obesity diagnostic criteria, while more than 50% of the population worldwide (about 30 hundred million people) is either overweight or obese. Morbid obesity is accompanied by hypertension, type II diabetes, ischemic heart disease, dyslipidemia, joint degeneration, sleep apnea, some tumors, etc. Therefore, how to effectively control body weight, prevent and control the occurrence of complications is a topic of great concern.

The main current treatment modalities for obesity include: diet control, life intervention, drug treatment, and surgical treatment. However, the satisfactory weight-reducing effect is hardly achieved by simple diet control, living intervention and drug treatment; although the effect of the weight-reduction surgery is obvious, the weight-reduction surgery is hardly accepted by patients due to cultural, medical level, surgical complications and the like.

Implantable medical devices, including intragastric balloons, have been attracting considerable attention in recent years to simulate the mechanism of surgical treatment of obesity, due to their safety, simplicity, effectiveness, and restorability, and may become a major effective means of weight loss in the future.

There are several types of intragastric balloons that are currently marketed abroad, and particularly intragastric balloons that are self-swallowed without being delivered through a gastroscope, are the direction of future weight loss means. The swallowed intragastric balloon is wrapped in the capsule before action and is connected with a longer catheter, one end of the catheter is connected with a self-closing valve on the intragastric balloon, and the other end of the catheter is left outside the capsule and the oral cavity. The balloon and part of the catheter wrapped in the capsule are sent into the stomach of a patient in a swallowing way, the capsule is rapidly degraded in the gastric acid environment, the filler is conveyed into the balloon from the outer end of the catheter left outside the oral cavity of the patient, and the balloon is inflated from an initial compressed state to an expanded state. After the filler is delivered, the catheter is pulled out from the patient, and the self-closing valve on the balloon and forming a fluid channel with the catheter is closed to prevent the filler from leaking. The structural integrity of the balloon is destroyed after the balloon remains in the patient for 4-6 months, the filler is expelled from the balloon into the patient's stomach, and the balloon and filler are naturally expelled from the patient's body through the gastrointestinal tract under gastrointestinal motility. However, these intragastric balloon systems have drawbacks in the way of connecting the catheter to the self-sealing valve, firstly, the larger volume is caused by the complex structure, and the larger volume makes patients easily experience dysphagia; another drawback is the difficulty in extracting the catheter from the balloon due to the irrational nature of the connection.

Disclosure of Invention

In order to solve the technical problem, the application provides a novel connection and release method and structure of a swallow type intragastric balloon system, and provides the swallow type intragastric balloon system comprising the novel connection and release structure, which is simple in structure, small in size, convenient for a patient to swallow, firm in connection between a catheter and a balloon before the filler is conveyed, and easy to separate after the filler is conveyed.

According to one embodiment of the present application, there is provided a novel connection and release structure for a swallowed intragastric balloon system including a balloon, a catheter, a capsule and a filler; the balloon is wrapped in the capsule, a self-sealing structure is arranged on the balloon, the distal end of the catheter is detachably connected with the self-sealing structure, the proximal end of the catheter is left outside the capsule, and filler is conveyed into the balloon through the proximal end so that the balloon is changed from an initial compressed state to an expanded state; the catheter is characterized in that an air bag is arranged at the distal end of the catheter, the air bag is inflated and then expanded, the outer diameter of the air bag is increased, the catheter and the air bag are relatively fixed, the air bag is deflated and retracted to a compressed state, the outer diameter of the air bag is reduced, and the catheter is separated from the self-sealing structure.

Further, the catheter is of a double-cavity structure and comprises a filler conveying cavity and an air bag cavity, a filler conveying valve and an air bag expansion valve are arranged at the proximal end of the catheter, the filler conveying valve is communicated with the filler conveying cavity, and the air bag expansion valve is communicated with the air bag cavity.

Still further, the pipe is coaxial double-cavity structure, the pipe includes inlayer and skin, the inside of inlayer constitutes the filler carries the chamber, constitute between inlayer and the inlayer the gasbag chamber.

Further, the self-sealing structure on the balloon is formed by welding two sides of a single-cavity hose or two layers of films.

In a preferred embodiment, the self-sealing structure is a self-sealing valve. The catheter is withdrawn from the self-sealing valve, withdrawn from the patient, and the self-sealing valve is automatically closed.

Further, the outer layer of the distal end of the catheter locally contains the balloon, the balloon is inflated by the balloon inflation valve, the outer diameter is increased, the balloon is retracted after pressure relief, and the outer diameter is reduced. When the air bag is not inflated, the outer diameter of the air bag is smaller than the inner diameter of the self-closing valve, and the catheter can be freely drawn in the self-closing valve. After the air bag is inflated, the air bag expands after inflation, the outer diameter of the air bag is increased, the outer diameter of the air bag is equal to or larger than the inner diameter of the self-sealing valve, and the catheter and the air bag are relatively fixed.

Further, the air bag is fixed inside the self-sealing valve and is positioned at the proximal end, the middle part or the distal end of the self-sealing valve, the air bag is inflated and then expanded, the outer diameter is increased, the friction force between the air bag and the inner wall of the self-sealing valve is relatively large, so that the relative fixation of the catheter and the air bag is realized, the air bag is deflated and then retracted, the outer diameter of the air bag is reduced, and the catheter is separated from the self-sealing structure.

In one embodiment, the balloon is secured to the exterior of the self-sealing valve and the balloon extends from the distal end of the self-sealing valve into the balloon. The balloon is inflated and then expanded, the outer diameter is increased, the balloon is clamped at the far end of the self-sealing valve to realize the relative fixation of the catheter and the balloon, the balloon is deflated and then retracted, the outer diameter of the balloon is reduced, and the catheter is separated from the self-sealing structure.

In one embodiment, the filler is a gas, liquid or other fluid, and the balloon is gradually changed from a compressed state to an inflated state by the filler.

In another embodiment, a dry hydrogel powder is pre-installed in the balloon, and water is delivered into the balloon through a filler delivery valve, and the hydrogel powder swells the balloon after absorbing water.

Further, the outer diameter of the balloon is restored to the original state, i.e., the non-expanded state, by venting the gas in the balloon lumen through the balloon inflation valve.

Further, the outer diameter of the balloon is restored to the original state, i.e., the non-expanded state, by suction.

Further, the balloon in the expanded state is left in the patient for 4-6 months and then degraded by itself or foreign substances, the structural integrity is destroyed, the filler is discharged from the balloon into the stomach of the patient, and the balloon and the filler are naturally discharged from the patient through the gastrointestinal tract under gastrointestinal peristalsis.

In a preferred embodiment, the balloon is provided with an X-ray or ultrasound developable marker to facilitate viewing of the balloon's position within the patient.

This application adopts novel connection and release mode between pipe and self-closing valve, and this kind of novel connection and release mode not only simple structure, and the volume is less, and the patient of being convenient for swallows, and pipe and sacculus firm in connection before carrying the filler moreover, easy operation can easily separate after carrying.

Drawings

FIG. 1 is a schematic structural view of a catheter according to one embodiment of the present application;

FIG. 2 is a schematic illustration of the relative positions of a catheter and a balloon (in a compressed state) according to one embodiment of the present application;

FIG. 3 is an enlarged view of a portion of a catheter balloon before inflation and a self-sealing valve according to one embodiment of the present application;

FIG. 4 is an enlarged view of a portion of a catheter balloon after inflation and a self-sealing valve according to one embodiment of the present application;

FIG. 5 is an enlarged view of a portion of a catheter balloon after inflation and a self-sealing valve according to another embodiment of the present application;

FIG. 6 is a schematic view of the catheter balloon separated from the balloon after deflation and pressure relief of the balloon after delivery of the filler according to one embodiment of the present application.

The components represented by the reference numerals in the drawings are as follows:

1: a balloon; 2: a conduit; 11: a self-closing valve; 22: an air bag expansion valve; 23: an air bag cavity; 24: a filler delivery chamber; 25: an air bag; 26: an outer layer of the catheter; 27: inner layer of catheter

Detailed Description

The following description of the embodiments of the present invention will be made clearly and fully, and it is apparent that the embodiments described are only some, but not all, of the embodiments of the present application. All other embodiments, which can be made by one of ordinary skill in the art based on the embodiments of the present application without making any inventive effort, are intended to be within the scope of the present application.

Referring to fig. 1-6, an intragastric balloon system according to the present application includes aballoon 1, acatheter 2, a capsule and a filler. Theballoon 1 is enclosed in a capsule (not shown) prior to swallowing, and thecatheter 2 is connected at one end (i.e., distal or in-vivo end) to a self-sealing structure on theballoon 1, while the other end (i.e., proximal or in-vitro end) remains outside the capsule and the patient's mouth. After the patient swallows thecapsule containing balloon 1, a filler (not shown) is delivered intoballoon 1 through the outer end ofcatheter 2, andballoon 1 changes from the initial compressed state to the inflated state, occupying the stomach volume of the patient and remaining for a predetermined period of time, for example 4-6 months. A portion of thematerial comprising balloon 1 degrades by itself or by foreign substances after 4-6 months in the patient's stomach.

The self-sealing structure on theballoon 1 is formed by welding two sides of a single-cavity hose or two layers of films. Specifically, the self-sealing structure is a self-sealingvalve 11.

Referring to fig. 1, fig. 1 is a schematic structural view of a catheter according to an embodiment of the present application. Thecatheter 2 is of a coaxial double-cavity structure and comprises anouter layer 26 and aninner layer 27, theinner layer 27 forms afiller conveying cavity 24, and aballoon cavity 23 is arranged between theouter layer 26 and theinner layer 27. The proximal end (i.e. the outer end) of thecatheter 2 is provided with afiller delivery valve 21 and aballoon expansion valve 22, saidfiller delivery valve 21 being in communication with saidfiller delivery lumen 24 and saidballoon expansion valve 22 being in communication with saidballoon lumen 23.

Referring to fig. 4 and 5, theouter layer 26 at the distal end (i.e., the inner end) of thecatheter 2 contains aballoon 25 locally, and theballoon 25 is inflated by theballoon inflation valve 22 to expand the balloon, thereby increasing the outer diameter, and theballoon 25 is deflated after the pressure is released. The inflation of theballoon 25 increases the outer diameter and the frictional force between thecatheter 2 and the self-sealingvalve 11 is large, thereby ensuring that thecatheter 2 does not separate from theballoon 1 before and during the delivery of the filler into theballoon 1 through thecatheter 2. After the filling is delivered, the air bag cavity is deflated or sucked to a negative pressure state, theair bag 25 is retracted, the outer diameter is reduced, and thecatheter 2 and the self-closing valve 11 can be easily separated.

As shown in fig. 2-4, the portion of the distal end ofcatheter 2 containingballoon 25 is inserted into self-sealingvalve 11 ofballoon 1 prior to oral administration to a patient, andballoon 25 is in a non-expanded state, andcatheter 2 is free to be withdrawn within self-sealing valve 11. After theballoon 25 has partially reached the predetermined position in the self-sealingvalve 11, theballoon chamber 23 is inflated by theballoon expansion valve 22, theballoon 25 is inflated to the state of fig. 4, and theballoon 25 is in sufficient contact with the inner wall of the self-sealingvalve 11, and the frictional force between thecatheter 2 and the self-sealingvalve 11 is relatively large at this time, so that it is ensured that thecatheter 2 and theballoon 1 are firmly fixed and not separated from each other before and during the delivery of the filler into theballoon 1 through thecatheter 2.

Theballoon 25 may be secured to the proximal end, mid-section, distal end of the self-sealingvalve 11, or beyond the distal end of the self-sealingvalve 11 into the balloon, as shown in fig. 5.

While maintaining the inflated state of theballoon 25, a certain amount of filler, which may be a gas, a liquid or other fluid, is delivered into theballoon 1 through thefiller delivery valve 21. Under the effect of the filler, theballoon 1 is gradually changed from the compressed state to the inflated state. In another embodiment, the hydrogel powder in a dry state is pre-installed in the balloon, water is delivered into theballoon 1 through thefiller delivery valve 21, and theballoon 1 is inflated after the hydrogel absorbs water. After the filling is delivered, the gas in theballoon chamber 23 is discharged through theballoon expansion valve 22, and further, the outer diameter of theballoon 25 is returned to the initial state, i.e., the non-expanded state, by suction. At this time, thecatheter 2 is withdrawn from the self-sealingvalve 11 and withdrawn from the patient. The self-closingvalve 11 automatically closes, preventing the internal filling of theballoon 1 from leaking out, as shown in fig. 6.

Theballoon 1 in the expanded state is left in the patient for 4-6 months and then is degraded by itself or foreign substances, the structural integrity of the balloon is destroyed, the filler is discharged into the stomach of the patient, and the balloon and the filler are naturally discharged out of the patient through the gastrointestinal tract under gastrointestinal peristalsis.

In a preferred embodiment, theballoon 1 is further provided with X-ray or ultrasound developable markers to facilitate viewing of the balloon's position within the patient.

This application adopts novel connection and release mode between pipe and self-closing valve, according to the pipe of this application, self-closing valve structure and novel connection and release simple structure between the two, and is small, and the patient of being convenient for swallows, both can guarantee simultaneously that the filler is full of the connection firmness of pipe and sacculus before the sacculus, enables the filler again and is full of the light separation of pipe and sacculus after the sacculus.

The foregoing disclosure is only illustrative of the preferred embodiments of the present application and is not intended to limit the scope of the claims herein, as the equivalent of the claims herein shall be construed to fall within the scope of the claims herein.

Claims (9)

1. A novel connection and release structure for a swallowable intragastric balloon system comprising a balloon, a catheter, a capsule and a filler;

the balloon is wrapped in the capsule, a self-sealing structure is arranged on the balloon, the distal end of the catheter is detachably connected with the self-sealing structure, the proximal end of the catheter is left outside the capsule, and filler is conveyed into the balloon through the proximal end so that the balloon is changed from an initial compressed state to an expanded state; the catheter is characterized in that an air bag is arranged at the distal end of the catheter, the air bag is inflated and then expanded, the outer diameter is increased, the catheter and the air bag are relatively fixed, the air bag is deflated and retracted, the outer diameter of the air bag is reduced, and the catheter is separated from the self-sealing structure;

the catheter is of a double-cavity structure and comprises a filler conveying cavity and an air bag cavity, a filler conveying valve and an air bag expansion valve are arranged at the proximal end of the catheter, the filler conveying valve is communicated with the filler conveying cavity, and the air bag expansion valve is communicated with the air bag cavity;

the catheter is of a coaxial double-cavity structure, the catheter comprises an inner layer and an outer layer, the filler conveying cavity is formed in the inner layer, and the air bag cavity is formed between the outer layer and the inner layer;

the air bag is fixed inside the self-sealing valve and is positioned at the proximal end, the middle part or the distal end of the self-sealing valve, the air bag is inflated and then expanded, the outer diameter is increased, the friction force between the air bag and the inner wall of the self-sealing valve is relatively large, so that the relative fixation of the catheter and the air bag is realized, the air bag is deflated and retracted, the outer diameter of the air bag is reduced, and the catheter is separated from the self-sealing structure.

2. The novel attachment and release structure of a swallowable intragastric balloon system according to claim 1 wherein the self-sealing structure on the balloon is welded on both sides of a single lumen hose or two films.

3. The novel connection and release structure of a swallowable intragastric balloon system according to claim 2 wherein the self-sealing structure is a self-sealing valve which automatically closes upon withdrawal of the catheter from the self-sealing valve.

4. A novel connection and release structure of a swallowable intragastric balloon system according to any of claims 1-3, the filling being a gas, liquid or other fluid, under the effect of which the balloon is gradually changed from a compressed state to an inflated state.

5. A novel connection and release structure of a swallowable intragastric balloon system according to any of claims 1-3 wherein a dry hydrogel powder is pre-installed in the balloon, water being delivered into the balloon through a filler delivery valve, said hydrogel powder expanding the balloon upon absorption of water.

6. A novel connection and release structure of a swallowable intragastric balloon system according to any of claims 1-3, the outer diameter of the balloon being restored to a non-expanded state by venting gas in the lumen of the balloon through the balloon expansion valve.

7. A novel connection and release structure of a swallowable intragastric balloon system according to any of claims 1-3, the outer diameter of the balloon being returned to the non-expanded state by aspiration.

8. A novel attachment and release structure for a intragastric balloon system as claimed in any one of claims 1 to 3 wherein the balloon in its expanded state is self-degrading or foreign material degrading after 4 to 6 months in the patient's body, the structural integrity is destroyed, the filler is expelled from the balloon into the patient's stomach, and the balloon and filler are naturally expelled from the patient's body through the gastrointestinal tract under gastrointestinal motility.

9. A novel attachment and release structure for a swallowable intragastric balloon system according to any of claims 1-3, said balloon being provided with X-ray or ultrasound developable indicia thereon for facilitating viewing of the balloon's position within the patient.

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