CN111345927A

CN111345927A - Sacculus, sacculus connection structure and sacculus device

Info

Publication number: CN111345927A
Application number: CN201811567285.1A
Authority: CN
Inventors: 贾婧玮; 岳斌
Original assignee: Shanghai Microport Medical Group Co Ltd
Current assignee: Shanghai Microport Medical Group Co Ltd
Priority date: 2018-12-20
Filing date: 2018-12-20
Publication date: 2020-06-30
Also published as: WO2020125542A1

Abstract

The invention provides a balloon, a balloon connecting structure and a balloon device, wherein the balloon connecting structure is used for detachably connecting a balloon, the balloon connecting structure comprises an outer catheter and an inner catheter, one end of the outer catheter is used for being fixed with the outside of a self-closing structure, and when the outer catheter is acted by a first external force, the outer catheter is separated from the self-closing structure; one end of the inner tube is used for being fixed with the interior of the self-sealing structure, and when the outer tube is acted by a second external force, the inner tube is separated from the self-sealing structure; through the action of the first external force and the second external force, the balloon connecting structure can be conveniently separated from the balloon after the balloon reaches the stomach; when the outer catheter and the inner catheter are in a state of being separated from the self-sealing structure, the inner catheter can movably penetrate through the outer catheter. Preferably, after the balloon-connecting structure is separated from the balloon, the balloon-connecting structure and the balloon can be connected again when needed, so as to adjust the volume of the balloon.

Description

Sacculus, sacculus connection structure and sacculus device

Technical Field

The invention relates to the field of medical instruments, in particular to a balloon, a balloon connecting structure and a balloon device.

Background

Obesity refers to an excessive or abnormal distribution of fat in the human body. The international standard for determining the degree of obesity and health of a human body is the BMI index, i.e. height to weight squared, and BMI between 25 and 29 is evaluated as overweight, and over 30 is considered as obese. As a metabolic disease, the harm of obesity is not only reflected in fat accumulation, appearance influence and daily life, but also causes a series of related physical and psychological complications, threatening human health, wherein the most important and common complications comprise type 2 diabetes, cardiovascular diseases and the like. Obesity and its complications have become one of the biggest threats to human health. A study published in 2017 in the new england journal of medicine showed that one third of the world's population, about 22 billion, is overweight, and 10% of the population, about 7.12 billion, is obese. In the statistics of adult obesity and obese children, China ranks the first and the second respectively, the total obesity population is over 7000 thousands, and more than 20% of the population is children, so that a very large clinical need still exists for a safe and effective obesity treatment mode.

The basic principle of obesity treatment is to reduce food intake and increase energy expenditure to achieve a negative balance of energy and thus promote the consumption of accumulated fat in the body. At present, the main ways for treating obesity are the following three, the improvement of life style depends on the willpower of patients, the effect is common in people with multiple complications, the treatment is easy to repeat, and the treatment is often used as an auxiliary means in the treatment stage, so that the obesity is difficult to be cured. In the aspect of drug treatment, only orlistat is a currently approved drug for treating obesity in China, so that the drug has more contraindications, is easy to cause complications such as diarrhea and the like, and has a relatively common treatment effect. Surgical treatment is a well-known method for effectively treating obesity for a long time, and at present, the clinical application is mature, and the main four operation methods which are widely applied are as follows: gastric bypass, gastric sleeve resection, gastric band folding and biliopancreatic shunt and duodenal switch, however, no matter what kind of operation, the operation has a certain degree of damage to the organism and leads to the change of the post-operation physiological structure, a series of recent and long-term complications inevitably exist, and the application of the surgical operation is greatly limited.

The gastric balloon is a pure physical therapy mode, related instruments are sequentially approved in countries such as Europe and America in recent years, and the gastric balloon is expected to become a new hope for treating obesity. Intragastric balloon surgery mimics the principle of restriction of gastric volume by reducing gastric volume with a balloon causing a reduction in food intake and inducing a feeling of satiety after food intake. Simultaneously stimulate the mechanical and chemical receptors of the stomach, change the gastric emptying and regulate the level of gastric hormone so as to achieve the purpose of weight loss. The stomach sacculus has the most outstanding advantages of no wound, no need of cutting any gastrointestinal tract, no change of the anatomical structure of the digestive tract of the human body and relatively simple and convenient operation. The literature reports that perioperative complications are much lower than other operations, the operative mortality rate is zero, and few serious complications occur except early nausea and vomiting symptoms. The stomach saccule does not influence the absorption of the nutrient from the gastrointestinal tract, so that postoperative diarrhea and malnutrition are avoided. If the situation that the nutrition requirement is increased, such as trauma, pregnancy, and the like, is met, the gastric balloon can be taken out at any time.

In the prior stomach balloon treatment, how to convey the stomach balloon into a human body and separate a conveying device from the stomach balloon still remains a problem to be solved, the conveying device in the prior art has a complex structure, great difficulty is brought to processing and manufacturing, and meanwhile, the operation of separating the conveying device from the stomach balloon is very inconvenient; on the other hand, after the stomach balloon is implanted into a human body, the volume of the stomach balloon may need to be adjusted again, and no technology capable of effectively performing the operation is found at present; on the other hand, the balloon part of the gastric balloon is mostly made of elastic materials such as silica gel, and the selection of the materials is favorable for realizing the volume expansion of the balloon in the stomach, so that the aim of limiting the stomach volume is achieved. However, most of these materials are not degradable, so that they cannot release volume spontaneously, and need endoscopic operation when taken out, increasing the risk of operation. In addition, most gastric balloons require endoscopic means such as gastroscopy for implantation, which increases the risk of complications associated with internal diameters such as esophageal perforation and intestinal infarction.

Based on the problems in the prior art, there is a need to develop a new gastric balloon to better meet the needs of clinical application.

Disclosure of Invention

The invention aims to provide a balloon, a balloon connecting structure and a balloon device, so as to solve one or more problems in the prior art.

On one hand, in order to solve the technical problems, the invention provides a balloon connecting structure which is used for detachably connecting a balloon, wherein the balloon is provided with a self-sealing structure;

one end of the outer tube is used for being fixed with the outside of the self-closing structure, and when the outer tube is under the action of first external force, the outer tube is separated from the self-closing structure;

one end of the inner tube is used for being fixed with the interior of the self-sealing structure, and when the inner tube is acted by a second external force, the inner tube is separated from the self-sealing structure; the inner catheter is used for selectively communicating with or disconnecting from the balloon;

when the outer catheter or the inner catheter is in a state of being separated from the self-sealing structure, the inner catheter can movably penetrate through the outer catheter.

Optionally, the outer tube is used for interference fit with the self-sealing structure; or the outer catheter is provided with a buckle which is used for being clamped with the periphery of the self-closing structure.

Optionally, the inner tube is used for interference fit with the inside of the self-sealing structure; or the inner catheter is provided with a buckle which is used for being clamped with the inner part of the self-closing structure.

Optionally, at least one through hole is formed in the side wall of one end of the inner tube, which is located in the self-sealing structure.

Optionally, one end of the inner tube located in the self-sealing structure is provided with a needle structure.

Optionally, when the outer tube is subjected to an acting force opposite to the first external force, the outer tube is used for being fixed with the self-closing structure; the inner tube is adapted to be secured to the interior of the self-sealing structure when the outer tube is subjected to a force opposing the second external force.

In another aspect, to solve the above technical problem, the present invention provides a balloon for matching with the balloon connecting structure, including:

the balloon body is provided with a contraction state and an filling state;

the self-sealing structure is connected with the balloon body and provided with a connecting body and a valve main body, the connecting body is provided with a connecting hole for the inner catheter to penetrate through, and the outside of the connecting body is used for being fixed with the outer catheter; the valve body is disposed within the connector body for selectively connecting and disconnecting the balloon with the inner catheter.

Optionally, an annular protruding portion is formed on the outer periphery of the connecting body and used for being clamped with a buckle at one end of the outer conduit.

Optionally, the balloon body is of a double-layer structure, the outer layer of the balloon body is made of a degradable material, and the inner layer of the balloon body is made of an acid-soluble material.

Optionally, the outer layer of the balloon body is made of a material in which at least two or more degradable materials are mixed.

Optionally, the valve main body is a one-way valve and comprises a spring and a valve, one end of the spring is connected with the distal end of the connecting body, the other end of the spring is connected with the valve, and the spring is used for controlling the opening and closing of the valve through elastic force; the connecting body is also provided with at least one channel for communicating the balloon and the inner catheter when the valve is opened.

Optionally, the valve has a snap-fit structure thereon for connecting the inner conduit.

Optionally, the valve body is a self-sealing valve, and includes a valve, and the valve has a self-sealing structure.

In another aspect, to solve the above technical problems, the present invention provides a balloon apparatus, including the balloon connecting structure as described above, and the balloon as described above, wherein one end of the outer catheter is used to be fixed to the outside of the connecting body, and one end of the inner catheter is used to be connected to the valve main body or the connecting hole; and the inner catheter is in communication with the balloon when the inner catheter is in a first position relative to the connector body and is disconnected from the balloon when the inner catheter is in a second position relative to the connector body.

In the balloon, the balloon connecting structure and the balloon device provided by the invention, the balloon connecting structure is used for detachably connecting a balloon, the balloon connecting structure comprises an outer catheter and an inner catheter movably arranged in the outer catheter in a penetrating way, one end of the outer catheter is used for being fixed with the outside of the self-closing structure, and when the outer catheter is acted by a first external force, the outer catheter is separated from the self-closing structure; one end of the inner tube is used for being fixed with the interior of the self-sealing structure, and when the outer tube is acted by a second external force, the inner tube is separated from the self-sealing structure; the inner catheter is used for selectively communicating with or disconnecting from the balloon; through the action of the first external force and the second external force, the balloon connecting structure can be conveniently separated from the balloon after the balloon reaches the stomach; preferably, after the balloon connecting structure is separated from the balloon, the balloon connecting structure and the balloon can be connected again when needed so as to adjust the volume of the balloon; furthermore, the balloon body of the balloon is of a double-layer structure, the outer layer of the balloon body is made of degradable materials, the inner layer of the balloon body is made of acid-soluble materials, the balloon body can be automatically degraded after a certain time and is normally discharged out of the body along with in vivo metabolism, the use of an endoscope is avoided, and the use risk is reduced.

Drawings

It will be appreciated by those skilled in the art that the drawings are provided for a better understanding of the invention and do not constitute any limitation to the scope of the invention. Wherein:

FIG. 1 is a schematic illustration of a balloon apparatus provided in accordance with an embodiment of the present invention;

FIG. 2 is a schematic view of the overall structure of a balloon apparatus according to a preferred embodiment of the present invention, wherein the self-sealing structure is a one-way valve;

FIG. 3 is an enlarged partial view of the balloon apparatus provided in FIG. 2;

FIG. 4 is a schematic diagram of the overall structure of a balloon apparatus according to a preferred embodiment of the present invention, wherein the self-sealing structure is a self-sealing valve;

fig. 5 is an enlarged partial view of the balloon apparatus provided in fig. 4.

In the drawings:

100-balloon; 110-self-sealing structure; 111-a one-way valve; 112-a connection body; 113-self-sealing valve; 114-a boss; 120-balloon body; 200-balloon connection structure; 210-an inner catheter; 220-an outer catheter; 230-luer fitting.

Detailed Description

To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is to be noted that the drawings are in greatly simplified form and are not to scale, but are merely intended to facilitate and clarify the explanation of the embodiments of the present invention. Further, the structures illustrated in the drawings are often part of actual structures. In particular, the drawings may have different emphasis points and may sometimes be scaled differently.

As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, the term "proximal" generally being the end that is closer to the operator and the term "distal" generally being the end that is closer to the site of the patient's lesion.

Referring to fig. 2 and 3, an embodiment of the present invention provides a balloon device that can be swallowed or the like into the stomach. The balloon device comprises a balloon 100 and a balloon connecting structure 200, wherein the balloon 100 comprises a balloon body 120 and a self-sealing structure 110. The balloon connection structure 200 includes an inner catheter 210 and an outer catheter 220, the inner catheter 210 being movably disposed through the outer catheter 220, preferably coaxially disposed. The balloon body 120 has a contracted state and an inflated state, and the volume of the balloon body can be changed according to the amount of the accommodated contents, and the balloon body occupies a part of the stomach volume by the volume of the balloon body, so that the purpose of reducing the amount of food is achieved. The self-sealing structure 110 is connected to the balloon body 120, specifically to the proximal end of the balloon body 120, the self-sealing structure 110 includes a connecting body 112 and a valve main body (a one-way valve 111 in fig. 3), the valve main body is a device capable of automatically closing, that is, when no external force or no external member acts on the valve main body, the valve main body is in a closed state, and can seal the inner cavity of the balloon body 120, so that the inner cavity of the balloon body 120 is not communicated with the outside; a valve body is disposed within the connector body 112 for selectively placing the balloon 100 in and out of communication with the inner catheter 210. And when the valve main body is subjected to an external force or an external member acts thereon, it can communicate the inner cavity of the balloon body 120 with the outside. Wherein, the connecting body 112 preferably has a connecting hole for the inner conduit 210 to pass through; and the exterior of the connector body 112 is adapted to be secured to the outer catheter 220. During actual assembly, one end of the outer tube 220 is fixed to the exterior of the self-sealing structure 110, and when the outer tube 220 is subjected to a first external force, the outer tube 220 is separated from the self-sealing structure 110; one end of the inner tube 210 is fixed to the interior (valve body or attachment hole) of the self-sealing structure 110, and when the inner tube 210 is subjected to a second external force, the inner tube 210 is separated from the self-sealing structure 110.

The inner catheter 210 is used to selectively communicate with or disconnect from the balloon 100: when the inner tube 210 is fixed to the self-sealing structure 110, the valve body can be conducted under the action of the inner tube 210, so that the inner tube 210 is communicated with the balloon 100; when the inner catheter 210 is separated from the self-sealing structure 110, the valve body is closed, disconnecting the inner catheter 210 from the balloon 100. When one end of the inner tube 210 is connected to the valve body of the self-sealing structure 110 (at this time, the valve body may be in a closed state), after entering the stomach of a human body, an operator may operate the inner tube 210 to apply an external force to the valve body, so that the valve body is opened, and then liquid is injected into the balloon 100 through the inner tube 210 and the valve body; in other embodiments, when one end of the inner catheter 210 is fixed to the connection hole of the connection body 112, an external force is applied to the valve body by the inner catheter 210 before entering the human body, so that the valve body is opened, i.e., the valve body is kept open before and after the balloon connection structure 200 enters the human body, until the inner catheter 210 is removed and the valve body is closed.

Specifically, when the balloon 100 abuts against the stomach wall, when a force (a first external force) axially away from the self-sealing structure 110 is applied to the outer catheter 220, the outer catheter 220 is separated from the self-sealing structure 110, and then a force (a second external force) axially away from the self-sealing structure 110 is further applied to the inner catheter 210, so that the inner catheter 210 can be separated from the self-sealing structure 110, and the whole balloon connection structure 200 is withdrawn. Therefore, after the balloon 100 reaches the stomach, the balloon connecting structure 200 can be conveniently separated from the balloon 100, and the self-closing structure 110 can be automatically closed; after the balloon connection structure 200 is separated from the balloon 100, the balloon connection structure 200 and the balloon 100 may be connected again as needed, so that the volume of the balloon 100 may be adjusted again through the balloon connection structure 200, specifically, the position of the balloon 100 may be limited with the help of a gastroscope, then a force (i.e., an acting force opposite to the second external force) axially facing the self-sealing structure 110 is applied to the inner catheter 210, the inner catheter 210 and the self-sealing structure 110 are aligned and inserted into the connecting hole, the inner catheter 210 and the self-sealing structure 110 may be fixedly connected again, and then a force (i.e., an acting force opposite to the first external force) axially facing the self-sealing structure 110 is applied to the outer catheter 220, so that the outer catheter 220 and the self-sealing structure 110 are fixed, and the balloon connection structure 200 and the balloon 100 may be connected again. Of course, another balloon connection structure 200 may be used to connect to the balloon 100, and the invention is not limited in this regard.

Compared with the existing balloon device, the balloon device is large in size due to complex structure, so that the patient has difficulty in swallowing the balloon device into the stomach. The balloon device provided by the embodiment has a simple structure, is convenient to use, and can separate and reconnect the balloon connecting structure 200 and the balloon 100 in a simple manner.

Preferably, the outer tube 220 is used for interference fit with the self-sealing structure 110; or the outer tube 220 has a snap 221 for snapping onto the outer circumference of the self-sealing structure 110. Referring to fig. 3, the outer tube 220 may have a buckle 221 (preferably L-shaped), and an annular protrusion 114 is formed on the outer circumference of the connecting body 112 of the self-sealing structure 110, and the buckle 221 may be buckled with the protrusion 114. Here, the buckle 221 may be disposed at the end of the outer catheter 220 or at a position close to the end, and the protrusion 114 is disposed to match the position of the buckle 221, preferably, the buckle 221 is clamped between the balloon body 120 and the protrusion 114. Specifically, the distal end of the latch 221 may be a slope, and the normal direction of the slope faces the axial direction of the outer tube 220, i.e. the slope is gradually expanded from the proximal end to the distal end, so that the latch 221 forms an inverted triangle, and when a force is applied to the outer tube 220 in the axial direction toward the self-sealing structure 110, the latch 221 can be easily latched with the protrusion 114. Of course, in other embodiments, the outer conduit 220 may also be connected to the outer circumference of the connector body 112 by an interference fit, i.e., the inner diameter of the outer conduit 220 is slightly smaller than the outer diameter of the connector body 112.

Further, the inner tube 210 can be coupled with the connection body 112 (connection hole) of the self-sealing structure 110 by interference fit, i.e. the outer diameter of the inner tube 210 is slightly larger than the inner diameter of the connection hole. Certainly, in other embodiments, a raised buckle may be further disposed on the periphery of the inner conduit 210, and a groove matched with the buckle is disposed on the inner wall of the connection hole, so that the inner conduit 210 and the connection hole are connected by clamping; or the outer tube 220 and the inner tube 210 are connected to the self-sealing structure 110 by clamping, or the outer tube 220 and the inner tube 210 are connected to the self-sealing structure 110 by interference fit, and the like, which is not limited in the present invention.

Preferably, as shown in fig. 3, the valve body is a one-way valve 111, and includes a spring and a valve, one end of the spring is connected to the distal end of the connecting body 112, and the other end of the spring is connected to the valve, and the spring is used for controlling the opening and closing of the valve by elastic force; the connecting body 112 also has at least one passage for communicating the balloon 100 with the inner catheter 210 when the valve is open. When the balloon 100 and the balloon connecting structure 200 are matched to form a balloon device, one end of the inner catheter 210 abuts against the valve of the one-way valve 111 (i.e. the inner catheter 210 is located at the first position relative to the connecting body 112), and applies pressure to the spring, so that the one-way valve 111 is in a conducting state, and the interior of the balloon body 120 is communicated with the inner catheter 210. Further, referring to fig. 2, a standard luer 230 is connected to the other end of the inner catheter 210, and a liquid, such as saline, can be injected into the inner catheter 210 through the luer 230, the liquid can enter the balloon body 120 through the conducted one-way valve 111 to make the balloon body 120 in an inflated state, or the liquid can be pumped out through the luer 230 to make the volume of the balloon body 120 shrink. When the inner catheter 210 is removed (i.e. the inner catheter 210 is in the second position relative to the connecting body 112), the valve of the one-way valve 111 is closed under the action of the spring, and the liquid in the balloon body 120 is enclosed.

In this embodiment, a through hole is provided at the distal end of the inner catheter 210, so that when one end of the inner catheter 210 abuts against the valve of the one-way valve 111, the interior of the balloon body 120 communicates with the inner catheter 210 through the through hole and the passage of the connecting body 112.

In another embodiment, as shown in fig. 5, the valve body is a self-sealing valve 113, and no channel is required on the connecting body 112 for communicating the balloon 100 and the inner catheter 210. In this embodiment, a self-sealing valve 113 is disposed at the distal end of the connecting body 112, and seals the balloon 100 together with the connecting body 112. The self-sealing valve 113 is a structure made of a silicon sheet or a rubber sheet and has self-sealing characteristics, wherein the self-sealing characteristics refer to that the self-sealing valve has needling resistance and tearing resistance, can form sealing around a needle hole after being needled, and can automatically recover the original sealing structure after the needle is pulled out. An end of the inner tube 210 for connecting with the self-sealing structure 110 is provided with a needle structure, and when the balloon 100 and the balloon connecting structure 200 are matched to form a balloon device, the needle structure is inserted into and passes through the self-sealing valve 113 (i.e. the inner tube 210 is located at a first position relative to the connecting body 112). At this time, the inside of the balloon body 120 and the inner catheter 210 communicate through the needle structure. Similarly, a standard luer 230 is connected to the other end of the inner catheter 210, as shown in fig. 4, and the volume of the balloon body 120 can be changed by injecting or extracting liquid into or from the balloon body 120 through the luer 230. When the inner catheter 210 is removed (i.e., the inner catheter 210 is in the second position relative to the connecting body 112), the self-sealing valve 113 closes the hole left by the needle structure by deforming itself to seal the liquid in the balloon body 120.

Further, the balloon body 120 is of a double-layer structure, the outer layer of the balloon body 120 is made of degradable materials, so that the balloon is guaranteed to be degraded after a certain period of time (for example, 6 months or 12 months), and the inner layer of the balloon body 120 is made of acid-soluble materials, so that the inner layer of the balloon body 120 is also guaranteed to be dissolved after the outer layer of the balloon body 120 is degraded, and the purpose of quickly releasing the filling liquid is achieved. The balloon body 120 with the double-layer structure can avoid the rupture of the balloon body 120 in the filling process, and after a certain time, the liquid in the balloon body 120 can be discharged quickly. Preferably, the balloon body 120 is formed by separately molding an inner layer and an outer layer, and then assembling the two layers. Of course, in some embodiments, the two-layer structure of the balloon body 120 may be formed by co-extrusion, surface grafting, interfacial polymerization, or the like, or by adding one or more layers of degradable materials to the outer surface of the inner layer of the balloon body 120, wherein the additional means may include surface spraying, electrostatic spinning, filter deposition, self-assembly, or the like, which is not limited in the present invention.

One end of the balloon body 120 is connected to the self-sealing structure 110 and enclosed in a swallowable capsule shell that can be rapidly dissolved in gastric acid. Referring to fig. 1, in use, the capsule shell covering the balloon 100 and the distal end of the double-layered catheter (i.e. the inner catheter 210 and the outer catheter 220) of the balloon connection structure 200 are swallowed to the stomach through the esophagus, the capsule shell is rapidly dissolved in gastric acid to release the balloon, a volume of saline is injected into the balloon body 120 through the proximal luer 230, and after the balloon body 120 reaches a desired volume, a force is applied to move the outer catheter 220, the balloon body 120 is closed by withdrawing the double-layer catheter from the closed structure 110 and sealing the balloon body 120, so that the balloon body 120 can keep the volume, occupy the volume of the stomach and achieve the purpose of limiting the volume of the stomach. After a certain period of time (generally 6-12 months), the outer layer of the balloon body 120 is degraded, so that the inner layer of the balloon body 120 is exposed to gastric acid and then dissolved, liquid (normal saline) inside the balloon body 120 is rapidly released, and then the residual materials of the balloon 100 are normally discharged out of the body along with in vivo metabolism. If the patient is pregnant or has a wound, the balloon body 120 can be punctured by operating under a gastroscope, and the residual material of the balloon 100 can be taken out after the liquid is released, so that the volume of the stomach is restored to increase the food quantity. In addition, after the balloon 100 is implanted into the stomach, if the doctor judges that the volume of the balloon body 120 needs to be adjusted (released or increased) according to the condition of the patient, the doctor can be connected with the balloon 100 again through a balloon connecting structure 200 and can extract or inject liquid into the balloon body 120 under the assistance of gastroscope so as to adjust the volume of the balloon body 120.

Preferably, the outer layer material of the balloon body 120 can be a medical degradable material. Generally, one of polylactic acid, polycaprolactone, polyglycolide, lactic acid/glycolic acid copolymer, chitosan, collagen, fibroin and the like can be selected, or a mixture or composite material of two or more of these materials can be selected. The selection and combination of materials determines the degradation time of the outer layer of the balloon body 120, and the physician can freely select the degradation time according to the patient's condition. The inner layer of the balloon body 120 can be made of medical acid-soluble material. Generally, one of chitosan, acid-soluble protein and the like, or a mixture or composite of chitosan and acid-soluble protein and the like can be selected. The shell of the capsule is made of medical water-soluble/acid-soluble high polymer material. In general, materials such as gelatin and polyvinyl alcohol, or a mixture or composite of shell gelatin and polyvinyl alcohol, and the like can be selected. The double-layer catheter can be made of medical high polymer materials or medical silica gel materials. Generally, one of materials such as nylon, Pebax, polyurethane, polyethylene, polypropylene, etc., or a mixture or composite material of two or more of these materials, etc. may be selected.

In one embodiment, the outer layer of the balloon body 120 is made of a mixed material of polylactic acid/polycaprolactone 4/6, and the inner layer of the balloon body 120 is made of acid-soluble chitosan. The double-layer structure of the balloon body 120 is connected to a self-sealing structure 110, connected with the double-layer catheter through the self-sealing structure 110, and enclosed in the gelatin capsule shell. In an in vitro simulation test, the capsule shell can smoothly enter the stomach through the esophagus and dissolve in gastric acid, releasing the balloon 100. After confirming the position of the balloon 100 by X-ray, 500 to 700mL of physiological saline is injected into the luer 230 connected to the distal end of the inner catheter 210 using a syringe, and the balloon body 120 is inflated. After the balloon body 120 reaches the required volume, the outer catheter 220 is moved to expose the joint of the inner catheter 210 and the self-sealing structure 110, and the inner catheter 210 is separated from the self-sealing structure 110 by applying a force to the distal end of the inner catheter 210, so that the double-layer catheter is withdrawn. Under simulated gastric acid environment, the outer layer of the balloon body 120 is degraded in 6 months, the inner layer of the balloon body 120 is exposed in gastric acid and then dissolved, liquid in the balloon body 120 is released, and the residual part of the balloon 100 is discharged out of the body along with normal excretion.

In summary, in the balloon, the balloon connecting structure and the balloon apparatus provided by the present invention, the balloon connecting structure includes an outer tube and an inner tube movably inserted into the outer tube, one end of the outer tube is used for being fixed to the outside of the self-sealing structure, and when the outer tube is acted by a first external force, the outer tube is separated from the self-sealing structure; one end of the inner tube is used for being fixed with the interior of the self-sealing structure, and when the outer tube is acted by a second external force, the inner tube is separated from the self-sealing structure; the inner catheter is used for selectively communicating with or disconnecting from the balloon; through the action of the first external force and the second external force, the balloon connecting structure can be conveniently separated from the balloon after the balloon reaches the stomach; preferably, after the balloon connecting structure is separated from the balloon, the balloon connecting structure and the balloon can be connected again when needed so as to adjust the volume of the balloon; furthermore, the balloon body of the balloon is of a double-layer structure, the outer layer of the balloon body is made of degradable materials, the inner layer of the balloon body is made of acid-soluble materials, the balloon body can be automatically degraded after a certain time and is normally discharged out of the body along with in vivo metabolism, the use of an endoscope is avoided, and the use risk is reduced.

The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the appended claims.

Claims

1. A balloon connecting structure is used for detachably connecting a balloon, and the balloon is provided with a self-sealing structure;

one end of the inner tube is used for being fixed with the interior of the self-sealing structure, and when the inner tube is acted by a second external force, the inner tube is separated from the self-sealing structure;

2. A balloon connection structure according to claim 1, wherein the outer tube is adapted to be an interference fit with the self-sealing structure; or the outer catheter is provided with a buckle which is used for being clamped with the periphery of the self-closing structure.

3. A balloon connection structure according to claim 1, wherein the inner conduit is adapted for an interference fit with the interior of the self-sealing structure; or the inner catheter is provided with a buckle which is used for being clamped with the inner part of the self-closing structure.

4. A balloon connection structure according to claim 1, wherein at least one through hole is provided on a side wall of an end of the inner tube located inside the self-sealing structure.

5. A balloon apparatus according to claim 1, wherein a needle structure is provided at an end of the inner catheter located within the self-sealing structure.

6. A balloon device according to claim 1, wherein the outer catheter is adapted to be secured to the self-closing structure when the outer catheter is subjected to a force opposing the first external force; the inner tube is adapted to be secured to the interior of the self-sealing structure when the outer tube is subjected to a force opposing the second external force.

7. A balloon for mating with a balloon attachment structure according to any of claims 1-6, comprising:

the balloon body is provided with a contraction state and an filling state;

8. A balloon according to claim 7, wherein the connecting body is formed with an annular projection at its outer periphery for snap-fitting engagement with a catch at one end of the outer catheter.

9. A balloon according to claim 7 or 8, wherein the balloon body is of a double-layer structure, the outer layer of the balloon body being made of a degradable material and the inner layer of the balloon body being made of an acid-soluble material.

10. The balloon of claim 9, wherein the outer layer of the balloon body is made of a material in which at least two or more degradable materials are mixed.

11. The balloon of claim 7 or 8, wherein the valve body is a one-way valve comprising a spring and a valve, one end of the spring is connected to the distal end of the connecting body, and the other end of the spring is connected to the valve, and the spring is used for controlling the opening and closing of the valve through elastic force; the connecting body is also provided with at least one channel for communicating the balloon and the inner catheter when the valve is opened.

12. A balloon according to claim 11, wherein the valve has snap-fit formations thereon for connection to the inner catheter.

13. A balloon according to claim 7 or 8, wherein the valve body is a self-sealing valve, comprising a valve of a construction having self-sealing properties.

14. A balloon apparatus, comprising a balloon connection structure according to any one of claims 1-6, and a balloon according to claims 7-13, wherein one end of the outer catheter is adapted to be fixed to the outside of the connection body, and one end of the inner catheter is adapted to be connected to the valve main body or the connection hole; and the inner catheter is in communication with the balloon when the inner catheter is in a first position relative to the connector body and is disconnected from the balloon when the inner catheter is in a second position relative to the connector body.