A self - closing system

Abstract

The present application provides a self-sealing system for an in-vivo implanted balloon system. The balloon system includes a balloon, a catheter, and a filling material. The balloon includes a self-sealing valve through which the catheter passes and is sealingly connected to the catheter. At the distal end of the self-sealing valve, there is an inverted pocket and a sealing band. The catheter passes through a small hole in the self-sealing valve and enters the inverted pocket. The balloon is wrapped in a capsule before swallowing. One end of the catheter is connected to the self-sealing valve on the balloon, and the other end remains outside the capsule. The catheter has a certain length such that the outer end remains outside the oral cavity during use. After the filling material is fully filled and the catheter is withdrawn, the sealing band can tightly close the distal end of the inverted pocket to prevent leakage of the filling material.

Description

Technical Field

[0001] This application relates to an in-vivo implantable balloon system, and more particularly, to a self-sealing system for an in-vivo implantable balloon system. Background Art

[0002] In the past 20 years, the incidence of obesity worldwide, including adult obesity, senile obesity, and obesity in adolescents and children, has been soaring. According to statistics from the World Health Organization, in 2014, 15% of adult women and 11% of adult men were obese worldwide, which means that nearly one billion adults were obese worldwide in 2014. Optimistically, the obese population in China has surpassed that in the United States. In 2016, there were 89.6 million obese people in China (87.8 million obese people in the United States), including 43.2 million men and 46.4 million women. Obesity is usually accompanied by hypertension, type II diabetes, ischemic heart disease, dyslipidemia, joint degeneration, sleep apnea, and certain tumors. Therefore, how to effectively control body weight and prevent and control the occurrence of complications has become a topic of great concern.

[0003] Currently, the main treatment methods for obesity include: diet control, lifestyle intervention, drug treatment, and surgical treatment. However, simple diet control, lifestyle intervention, and drug treatment are difficult to achieve satisfactory weight loss effects; although weight loss surgery has obvious effects, it is difficult for patients to accept due to reasons such as culture, medical level, and surgical complications. Implantable medical devices for weight loss, which simulate the mechanism of surgical treatment of obesity, including intragastric balloons, have just emerged in recent years. Because of their safety, simplicity, effectiveness, and recoverability, they have received extensive attention and will become the main effective means of future weight loss.

[0004] Currently, several types of intragastric balloons have been marketed abroad. In particular, intragastric balloons that can be swallowed without passing through a gastroscope are the future direction of weight loss methods. The swallowable intragastric balloon is wrapped in a capsule before use and is connected to a long catheter. One end of the catheter is connected to a self-sealing valve on the intragastric balloon, and the other end remains outside the capsule and the oral cavity. The balloon and part of the catheter wrapped in the capsule are sent into the patient's stomach by swallowing. The capsule degrades rapidly in the acidic environment of the stomach, and the filler is delivered into the balloon from the external end of the catheter remaining outside the patient's oral cavity. The balloon expands from the initial compressed state to the expanded state. After the filler is delivered, the catheter is removed from the patient's body, and the self-sealing valve on the balloon that forms a fluid channel with the catheter automatically closes to prevent the filler from leaking. US Patent No. US8974483B2 discloses such a self-sealing valve for a catheter and a balloon, as specifically shown in the appendix Figure 1 as follows:

[0005] This catheter with a balloon self-sealing valve disclosed in US Patent US8974483B2 includes a catheter 1100 and a two-layer self-sealing valve 1110 sealed along the edge. The self-sealing valve 1110 can be positioned in a hole on the surface of the upper part 1014 or the lower part 1016 of the balloon, or in the opening of the seam 1004 between the upper part 1014 and the lower part 1016. The catheter 1100 passes through the channel 1020 between the two layers of the self-sealing valve 1110 from outside the balloon and enters the balloon. After delivering the filling material into the balloon, the catheter 1100 is withdrawn. The channel 1020 between the two layers of the self-sealing valve 1110 automatically closes to prevent the leakage of the filling material in the balloon.

[0006] The disadvantage of this structure is that the channel 1020 between the two layers of the self-sealing valve 1110 is completely self-sealed. After long-term storage, the catheter 1100 will cause deformation of the channel 1020. Therefore, after the catheter 1100 is withdrawn after the balloon is filled, the deformed channel 1020 cannot be completely closed, and the filling material in the balloon will leak. Summary of the Invention

[0007] This application provides a self-sealing system, which has a good sealing effect after the catheter is withdrawn from the balloon to prevent the leakage of the filling material.

[0008] The intragastric balloon system of this application includes a balloon, a catheter, and a filling material. The self-sealing valve can be positioned at any position of the balloon. The self-sealing valve can be penetrated by a catheter and is sealingly connected to the catheter. It is characterized in that there is an inverted pocket and a sealing band at the distal end of the self-sealing valve.

[0009] Preferably, the catheter passes through a small hole on the self-sealing valve and enters the inverted pocket.

[0010] Preferably, the sealing band is connected to the balloon.

[0011] Preferably, the balloon is wrapped in a capsule before swallowing. One end of the catheter is connected to the self-sealing valve on the balloon, and the other end remains outside the capsule. The catheter has a certain length so that the outer end remains outside the mouth during use.

[0012] Preferably, the balloon includes an upper main body and a lower main body, and the self-sealing valve includes an upper self-sealing valve and a lower self-sealing valve.

[0013] Preferably, a small hole is opened on the lower self-sealing valve, and the circumference of the small hole is not greater than the outer diameter of the catheter.

[0014] Preferably, the upper self-sealing valve and the upper main body are an integral body, or are connected together by different materials through bonding or welding. The lower self-sealing valve and the lower main body are an integral body, or are connected together by different materials through bonding or welding.

[0015] Preferably, the inverted pocket comprises an upper inverted pocket film and a lower inverted pocket film.

[0016] Preferably, the upper inverted pocket film is an extension of the lower self-sealing valve or is connected together by different materials through bonding or welding.

[0017] Preferably, the length of the lower inverted pocket film is greater than the length of the upper inverted pocket film.

[0018] Preferably, while the upper main body and the lower main body are combined together at the edge by bonding or welding, three sides of the upper self-sealing valve and the lower self-sealing valve are bonded or welded together by a connecting band to form a self-sealing valve.

[0019] Preferably, all or part of the lower self-sealing valve and the upper inverted pocket film are bonded or welded together with the lower inverted pocket film by a connecting band to form the inverted pocket, and the catheter penetrates through the unconnected ends of the upper self-sealing valve and the lower self-sealing valve and exits through the small hole and enters any position of the inverted pocket.

[0020] Preferably, the sealing band is on the outer side of the inverted pocket.

[0021] Preferably, the sealing band comprises an upper sealing strip and a lower sealing strip, wherein the upper sealing strip is on the outer side of the upper inverted pocket film and the lower sealing strip is on the outer side of the lower inverted pocket film.

[0022] Preferably, the length of the upper sealing strip is not less than the length of the lower sealing strip, and the length of the lower sealing strip is greater than the width of the lower inverted pocket film.

[0023] Preferably, both sides of the lower sealing strip are directly or indirectly connected together with the upper sealing strip by bonding or welding through the inverted pocket to form a sealing band.

[0024] Preferably, the sealing band is adhered to the balloon through both ends of the upper sealing strip.

[0025] Preferably, the length of the lower sealing strip is not less than the length of the upper sealing strip, and the length of the upper sealing strip is greater than the width of the upper inverted pocket film.

[0026] Preferably, both sides of the upper sealing strip are directly or indirectly connected together with the lower sealing strip by bonding or welding through the inverted pocket to form a sealing band.

[0027] Preferably, the sealing band is adhered to the balloon through both ends of the lower sealing strip.

[0028] Preferably, after the combination is completed, it is turned over through the hole on the upper main body. The upper main body and the lower main body form the balloon. The self-sealing valve, together with the inverted pocket and the sealing strip at its distal end, enters the interior of the balloon. One end of the catheter is outside the balloon and the other end is inside the inverted pocket. Finally, the hole on the upper main body is sealed with a patch.

[0029] Preferably, small holes are formed in the pocket film of the inverted pocket, and the perimeter of the small holes is not greater than the outer diameter of the catheter.

[0030] Preferably, the sealing strip is connected to the balloon main body.

[0031] Preferably, the balloon is wrapped in a capsule before swallowing. One end of the catheter is connected to the self-sealing valve on the balloon, and the other end remains outside the capsule. The catheter has a certain length such that the outer end remains outside the mouth during use.

[0032] Preferably, the balloon includes an upper main body and a lower main body, and the self-sealing valve includes an upper self-sealing valve and a lower self-sealing valve.

[0033] Preferably, the length of the pocket film is not greater than the length of the upper self-sealing valve.

[0034] Preferably, the sealing strip includes a left sealing strip and a right sealing strip, which are respectively on both sides of the distal end of the upper self-sealing valve or the lower self-sealing valve.

[0035] Preferably, the left sealing strip and the right sealing strip are an integral part of the upper self-sealing valve or the lower self-sealing valve, or are connected together by different materials through bonding or welding.

[0036] Preferably, the pocket film is connected to the lower self-sealing valve along the connecting strip through bonding or welding to form the inverted pocket, and the small holes are on the inverted pocket.

[0037] Preferably, the upper main body and the lower main body are combined together at the edge through bonding or welding. At the same time, three sides of the upper self-sealing valve are connected to the lower self-sealing valve and the inverted pocket through connecting strips to form the self-sealing valve.

[0038] Preferably, the catheter penetrates through the unconnected ends of the upper self-sealing valve and the lower self-sealing valve, passes through the small holes, and enters any position of the inverted pocket.

[0039] Preferably, the left sealing strip and the right sealing strip are respectively adhered to the balloon.

[0040] Preferably, after the combination is completed, it is flipped through the hole on the upper body. The upper body and the lower body form the balloon. The self-sealing valve together with the inverted pocket and the sealing band at its distal end enter the interior of the balloon. One end of the catheter is outside the balloon and the other end is inside the inverted pocket. Finally, the hole on the upper body is sealed with a patch.

[0041] The present application provides a method for manufacturing a self-sealing system as claimed in the claims. The balloon body includes an upper body and a lower body. The self-sealing valve includes an upper self-sealing valve and a lower self-sealing valve. It is characterized in that: while the upper body and the lower body are combined together at the edge by bonding or welding, three sides of the upper self-sealing valve and the lower self-sealing valve are bonded or welded together by a connecting band to form the self-sealing valve. A small hole is opened on the lower self-sealing valve. All or part of the lower self-sealing valve and the upper inverted pocket film are bonded or welded together with the lower inverted pocket film by a connecting band to form the inverted pocket. The catheter penetrates through the unconnected ends of the upper self-sealing valve and the lower self-sealing valve and exits through the small hole and enters any position in the inverted pocket.

[0042] Preferably, the sealing band is on the outer side of the inverted pocket and includes an upper sealing strip and a lower sealing strip. Among them, the upper sealing strip is on the outer side of the upper inverted pocket film, and the lower sealing strip is on the outer side of the lower inverted pocket film. The sealing band is adhered to the balloon through both ends of the upper sealing strip.

[0043] Preferably, after the combination is completed, it is flipped through the hole on the upper body. The upper body and the lower body form the balloon body. The self-sealing valve together with the inverted pocket and the sealing band at its distal end enter the interior of the balloon body. One end of the catheter is outside the balloon and the other end is inside the inverted pocket. Finally, the hole on the upper body is sealed with a patch.

[0044] The present application provides another method for manufacturing a self-sealing system. The balloon body includes an upper body and a lower body. The self-sealing valve includes an upper self-sealing valve and a lower self-sealing valve. It is characterized in that: while the upper body and the lower body are combined together at the edge by bonding or welding, three sides of the upper self-sealing valve and the lower self-sealing valve are bonded or welded together by a connecting band to form the self-sealing valve. A small hole is opened on the lower self-sealing valve. All or part of the lower self-sealing valve and the upper inverted pocket film are bonded or welded together with the lower inverted pocket film by a connecting band to form the inverted pocket. The catheter penetrates through the unconnected ends of the upper self-sealing valve and the lower self-sealing valve and exits through the small hole and enters any position in the inverted pocket.

[0045] Preferably, the sealing band is on the outer side of the inverted pocket, including an upper sealing strip and a lower sealing strip. The upper sealing strip is on the outer side of the upper inverted pocket film, and the lower sealing strip is on the outer side of the lower inverted pocket film. The sealing band is adhered to the balloon through both ends of the lower sealing strip.

[0046] Preferably, after the combination is completed, it is turned over through the hole on the upper main body. The upper main body and the lower main body form the balloon main body. The self-sealing valve together with the inverted pocket at its distal end and the sealing band enter the interior of the balloon main body. One end of the catheter is outside the balloon and the other end is inside the inverted pocket. Finally, the hole on the upper main body is sealed with a patch.

[0047] The present application also provides a method for manufacturing a self-sealing system. The balloon includes an upper main body and a lower main body, and the self-sealing valve includes an upper self-sealing valve and a lower self-sealing valve. It is characterized in that: small holes are opened on the pocket film for making the inverted pocket, the perimeter of the small holes is not greater than the outer diameter of the catheter, the length of the pocket film is not greater than the length of the upper self-sealing valve, and the sealing band includes a left sealing strip and a right sealing strip, which are respectively on both sides of the lower self-sealing valve or the distal end of the lower self-sealing valve.

[0048] Preferably, first connect the pocket film with the lower self-sealing valve together along the connecting band by bonding or welding to form the inverted pocket, and the small holes are on the inverted pocket. Then combine the upper main body and the lower main body together at the edge by bonding or welding. At the same time, three sides of the upper self-sealing valve are also connected with the lower self-sealing valve and the inverted pocket through the connecting band to form the self-sealing valve. The catheter passes through the unconnected ends of the upper self-sealing valve and the lower self-sealing valve, passes out through the small holes, and enters any position of the inverted pocket. The left sealing strip and the right sealing strip are respectively adhered to the balloon.

[0049] Preferably, after the combination is completed, it is turned over through the hole on the upper main body. The upper main body and the lower main body form the balloon. The self-sealing valve together with the inverted pocket at its distal end and the sealing band enter the interior of the balloon. One end of the catheter is outside the balloon and the other end is inside the inverted pocket. Finally, the hole on the upper main body is sealed with a patch.

[0050] The self-sealing system of this solution is not only limited to the intragastric balloon system, but can also be used for other balloon implants, such as skin expansion balloons, etc.

[0051] In the self-sealing system of the present application, after the filling material is filled and the catheter is withdrawn, the sealing band can tightly close the distal end of the inverted pocket to prevent the filling material from leaking. Description of the Drawings

[0052] Figure 1 Schematic diagram of a self-sealing valve of a catheter and a balloon according to the prior art;

[0053] Figure 2 Schematic diagram of the connection between a balloon and a catheter according to an embodiment of the present application;

[0054] Figure 3 Schematic diagram of the disassembly of a balloon body and a valve according to an embodiment of the present application;

[0055] Figure 4 Schematic diagram of the disassembly of a balloon body, a valve and an inverted pocket according to an embodiment of the present application;

[0056] Figure 5 Schematic diagram of a valve, a pocket and a catheter according to an embodiment of the present application;

[0057] Figure 6 Schematic diagram of a valve, a pocket, a catheter and a sealing tape according to an embodiment of the present application;

[0058] Figure 7 Schematic diagram of a self-sealing system according to an embodiment of the present application;

[0059] Figure 8 Schematic diagram of a balloon, a self-sealing valve, an inverted pocket, a sealing tape and its disassembly according to another embodiment of the present application;

[0060] Figure 9 Schematic diagram of a catheter, a self-sealing valve, an inverted pocket, a sealing tape and its assembly according to another embodiment of the present application. Detailed implementation manners

[0061] See Figure 2 , which shows a schematic structural diagram of an intragastric balloon system according to an embodiment of the present application. The intragastric balloon system includes: a balloon 100, a catheter 200, a capsule and a filler (not shown in the figure). The balloon 100 contains a self-sealing valve 300, an inverted pocket 400 and a sealing tape 500. The balloon 100 is wrapped in the capsule before swallowing. One end (i.e., the in-vivo end) of the catheter 200 is connected to the self-sealing valve 300 on the balloon 100, and the other end (i.e., the ex-vivo end) remains outside the capsule. The catheter 200 has a certain length such that the ex-vivo end remains outside the oral cavity during use.

[0062] See Figure 3, which shows the balloon 100, the self-sealing valve 300 and their exploded views. The balloon 100 includes an upper main body 110 and a lower main body 120. The self-sealing valve 300 includes an upper self-sealing valve 310 and a lower self-sealing valve 320. A small hole 311 is provided on the lower self-sealing valve 320, and the perimeter of the small hole 311 is not greater than the outer diameter of the catheter 200. The upper self-sealing valve 310 and the upper main body 110 may be an integral body, or may be connected together by different materials through bonding or welding. Similarly, the lower self-sealing valve 320 and the lower main body 120 may be an integral body, or may be connected together by different materials through bonding or welding.

[0063] See Figure 4 , which shows the balloon 100, the self-sealing valve 300, the inverted pocket 400 and their exploded views. The inverted pocket 400 includes an upper inverted pocket film 410 and a lower inverted pocket film 420. The upper inverted pocket film 410 may be an extension of the lower self-sealing valve 320, or may be connected together by different materials through bonding or welding. The length of the lower inverted pocket film 420 is greater than the length of the upper inverted pocket film 410.

[0064] See Figure 5 , which shows the catheter 200, the self-sealing valve 300, the inverted pocket 400 and their exploded views. While the upper main body 110 and the lower main body 120 are combined together at the edges through bonding or welding, three sides of the upper self-sealing valve 310 and the lower self-sealing valve 320 are bonded or welded together by a connecting band 312 to form the self-sealing valve 300. All or part of the lower self-sealing valve 320 and the upper inverted pocket film 410 are bonded or welded together with the lower inverted pocket film 420 by a connecting band 421 to form the inverted pocket 400. The catheter 200 penetrates through the unconnected ends of the upper self-sealing valve 310 and the lower self-sealing valve 320, passes through the small hole 311, and enters any position of the inverted pocket 400.

[0065] See Figure 6 , which shows the catheter 200, the self-sealing valve 300, the inverted pocket 400, the sealing band 500 and their exploded views. The sealing band 500 is on the outside of the inverted pocket 400 and includes an upper sealing strip 510 and a lower sealing strip 520. The upper sealing strip 510 is on the outside of the upper inverted pocket film 410, and the lower sealing strip 520 is on the outside of the lower inverted pocket film 420. The length of the upper sealing strip 510 is not less than the length of the lower sealing strip 520, and the length of the lower sealing strip 520 is greater than the width of the lower inverted pocket film 420. Both sides of the lower sealing strip 520 are directly or indirectly connected to the upper sealing strip 510 through the inverted pocket 400 by bonding or welding to form the sealing band 500.

[0066] The sealing band 500 is adhered to the balloon 100 through both ends of the upper sealing strip 510.

[0067] Of course, those skilled in the art can also understand that, alternatively, the length of the lower sealing strip 520 is not less than the length of the upper sealing strip 510, and the length of the upper sealing strip 510 is greater than the width of the upper inverted pocket film 410. The two sides of the upper sealing strip 510 and the lower sealing strip 520 are directly or indirectly connected together through the inverted pocket 400 in a bonding or welding manner to form a sealing band. The sealing band 500 is adhered to the balloon through both ends of the lower sealing strip 520.

[0068] See Figure 7 , after the combination is completed, it is flipped through the hole 2 on the upper main body 110. The upper main body 110 and the lower main body 120 form the balloon 100, and the self-sealing valve 300 together with the inverted pocket 400 and the sealing band 500 at its distal end enter the interior of the balloon 100. One end of the catheter 200 is outside the balloon 100, and the other end is inside the inverted pocket 400. Finally, the hole 2 on the upper main body 110 is sealed with a patch.

[0069] The usage of the intragastric balloon according to this embodiment is as follows: After the patient swallows the capsule containing the balloon 100 and part of the catheter 200, the capsule dissolves rapidly in the gastric environment, and the filler is delivered into the balloon 100 through the external end of the catheter 200. The balloon 100 changes from the initial compressed state to the inflated state. Since the diameter of the small hole 311 is not greater than the outer diameter of the catheter 200, there is a gapless and tight fit between the catheter 200 and the small hole 311, ensuring the overall sealing performance of the balloon 100 and the self-sealing valve when delivering the filler, and the filler will not leak. After filling, the catheter 200 is withdrawn, and the sealing band 500 tightens the distal end of the inverted pocket 400, making the upper inverted pocket film 410 and the lower inverted pocket film 420 fit tightly together to prevent the leakage of the filler in the balloon 100. The balloon 100 occupies the gastric volume for a long time to achieve the purpose of weight loss.

[0070] Figures 8-9 Fig. shows a schematic structural diagram of an intragastric balloon system according to another embodiment of the present application.

[0071] See Figure 8, which shows the balloon 100, the self-sealing valve 300, the inverted pocket 400, the sealing strip 500 and their exploded views. The balloon 100 includes an upper main body 110 and a lower main body 120. The self-sealing valve 300 includes an upper self-sealing valve 330 and a lower self-sealing valve 340. The upper self-sealing valve 330 and the upper main body 110 can be an integral body or can be connected together by different materials through bonding or welding. Similarly, the lower self-sealing valve 340 and the lower main body 120 can be an integral body or can be connected together by different materials through bonding or welding. Small holes 311 are opened on the pocket film 430 for making the inverted pocket 400, and the perimeter of the small holes 311 is not greater than the outer diameter of the catheter 200. The length of the pocket film 430 is not greater than the length of the upper self-sealing valve 330. The sealing strip 500 includes a left sealing strip 530 and a right sealing strip 540, which are respectively on both sides of the distal end of the lower self-sealing valve 340. The left sealing strip 530 and the right sealing strip 540 and the lower self-sealing valve 340 can be an integral body or can be connected together by different materials through bonding or welding.

[0072] See Figure 9 , which shows the catheter 200, the self-sealing valve 300, the inverted pocket 400, the sealing strip 500 and their assembly drawing. First, the pocket film 430 is connected to the lower self-sealing valve 340 along the connecting strip 341 through bonding or welding to form the inverted pocket 400, and the small holes 311 are inside the inverted pocket. Then, the upper main body 110 and the lower main body 120 are combined together at the edge through bonding or welding. At the same time, three sides of the upper self-sealing valve 330 are also connected to the lower self-sealing valve 340 and the inverted pocket 400 through the connecting strip 331 to form the self-sealing valve 300. The catheter 200 penetrates into the self-sealing valve 300 from the unconnected ends of the upper self-sealing valve 330 and the lower self-sealing valve 340, passes through the small holes 311, and enters any position in the inverted pocket 400.

[0073] The left sealing strip 530 and the right sealing strip 540 of the sealing strip 500 are respectively adhered to the balloon 100.

[0074] See Figure 7 , after the combination is completed, it is turned over through the hole 2 on the upper main body 110. The upper main body 110 and the lower main body 120 form the balloon 100, and the self-sealing valve 300 together with the inverted pocket 400 and the sealing strip 500 at its distal end enter the inside of the balloon 100. One end of the catheter 200 is outside the balloon 100, and the other end is inside the inverted pocket. Finally, the hole 2 on the upper main body 110 is closed with a patch.

[0075] The usage of the intragastric balloon according to this embodiment is as follows: After the patient swallows the capsule containing the balloon 100 and a part of the catheter 200, the capsule dissolves rapidly in the gastric environment. Fillers are delivered into the balloon 100 through the external end of the catheter 200. The balloon 100 changes from the initial compressed state to the inflated state. Since the diameter of the small hole 311 is not greater than the outer diameter of the catheter 200, there is a gapless and tight fit between the catheter 200 and the small hole 311, ensuring the overall sealing performance of the balloon 100 and the self-sealing valve when delivering fillers, and the fillers will not leak out. After filling, the catheter 200 is pulled out, and the sealing band 500 tightens the distal end of the inverted pocket 400, making the upper inverted pocket film 410 and the lower inverted pocket film 420 fit tightly together to prevent the leakage of the fillers in the balloon 100. The balloon 100 occupies the gastric volume for a long time to achieve the purpose of weight loss.

[0076] The above-disclosed are only several preferred embodiments of the present application. Of course, the scope of rights of the present application cannot be limited thereby. Therefore, equivalent changes made according to the claims of the present application still fall within the scope covered by the present application.

Claims

1. A self-sealing system for an in-vivo implanted balloon system, the balloon system comprising a balloon, a catheter, and a filler, the balloon including a self-sealing valve through which the catheter passes and is sealingly connected thereto, characterized in that: There is an inverted pocket and a sealing band at the distal end of the self-sealing valve; The catheter passes through a small hole in the self-sealing valve and enters the inverted pocket, and the sealing band is connected to the balloon; The balloon includes an upper body and a lower body, and the self-sealing valve includes an upper self-sealing valve and a lower self-sealing valve; A small hole is formed in the lower self-sealing valve, and the circumference of the small hole is not greater than the outer diameter of the catheter; While the upper body and the lower body are combined together at the edge by bonding or welding, three sides of the upper self-sealing valve and the lower self-sealing valve are bonded or welded together by a connecting band to form a self-sealing valve; All or part of the lower self-sealing valve and the upper inverted pocket film are bonded or welded together with the lower inverted pocket film by a connecting band to form the inverted pocket, and the catheter penetrates through the unconnected ends of the upper self-sealing valve and the lower self-sealing valve and exits through the small hole and enters any position in the inverted pocket.

2. The self-sealing system according to claim 1, characterized in that: The balloon is wrapped in a capsule before swallowing, one end of the catheter is connected to the self-sealing valve on the balloon, and the other end remains outside the capsule, and the catheter has a certain length such that the outer end remains outside the mouth during use.

3. The self-sealing system according to claim 2, characterized in that: The upper self-sealing valve and the upper body are an integral body, or are connected together by different materials through bonding or welding.

4. The self-sealing system according to claim 3, characterized in that: The lower self-sealing valve and the lower body are an integral body, or are connected together by different materials through bonding or welding.

5. The self-sealing system according to claim 4, characterized in that: The sealing band is on the outside of the inverted pocket.

6. The self-sealing system according to claim 5, characterized in that: The sealing band includes an upper sealing strip and a lower sealing strip, wherein the upper sealing strip is on the outside of the upper inverted pocket film, and the lower sealing strip is on the outside of the lower inverted pocket film.

7. The self-sealing system according to claim 6, characterized in that: The length of the upper sealing strip is not less than the length of the lower sealing strip, and the length of the lower sealing strip is greater than the width of the lower inverted pocket film.

8. The self-sealing system according to claim 7, characterized in that: Both sides of the lower sealing strip are directly or indirectly connected to the upper sealing strip through the inverted pocket by bonding or welding to form a sealing band.

9. The self-sealing system according to claim 8, characterized in that: The sealing band is adhered to the balloon through both ends of the upper sealing strip.

10. The self-sealing system according to claim 6, characterized in that: The length of the lower sealing strip is not less than the length of the upper sealing strip, and the length of the upper sealing strip is greater than the width of the upper inverted pocket film.

11. The self - closing system according to claim 10, wherein: Both sides of the upper sealing strip are directly or indirectly connected to the lower sealing strip through an inverted pocket by bonding or welding to form a sealing band.

12. The self - closing system according to claim 11, wherein: The sealing band is adhered to the balloon through both ends of the lower sealing strip.

13. The self - closing system according to claim 9 or 12, wherein: After assembly, it is flipped through the hole on the upper main body. The upper main body and the lower main body form the balloon. The self - closing valve together with the inverted pocket and the sealing band at its distal end enter the interior of the balloon. One end of the catheter is outside the balloon and the other end is inside the inverted pocket. Finally, the hole on the upper main body is closed with a patch.

14. A self - closing system for an in - vivo implantable balloon system, the balloon system comprising a balloon, a catheter, and a filler, the balloon including a self - closing valve through which the catheter passes and is sealingly connected thereto, wherein: There is an inverted pocket and a sealing band at the distal end of the self - closing valve; Small holes are opened on the pocket film of the inverted pocket, the perimeter of the small holes is not greater than the outer diameter of the catheter, and the sealing band is connected to the balloon; The balloon includes an upper main body and a lower main body, and the self - closing valve includes an upper self - closing valve and a lower self - closing valve; The pocket film is connected to the lower self - closing valve along the connecting band by bonding or welding to form the inverted pocket, and the small holes are on the inverted pocket; The upper main body and the lower main body are combined at the edges by bonding or welding. At the same time, three sides of the upper self - closing valve are connected to the lower self - closing valve and the inverted pocket through the connecting band to form the self - closing valve; The catheter penetrates through the unconnected ends of the upper self - closing valve and the lower self - closing valve, passes through the small holes, and enters any position in the inverted pocket.

15. The self - closing system according to claim 14, wherein: Before swallowing, the balloon is wrapped in a capsule. One end of the catheter is connected to the self - closing valve on the balloon, and the other end remains outside the capsule. The catheter has a certain length such that the external end remains outside the mouth during use.

16. The self - closing system according to claim 15, wherein: The length of the pocket film is not greater than the length of the upper self - closing valve.

17. The self - closing system according to claim 16, wherein: The sealing band includes a left sealing strip and a right sealing strip, which are respectively on both sides of the distal end of the upper self - closing valve or the lower self - closing valve.

18. The self - closing system according to claim 17, wherein: The left sealing strip and the right sealing strip are integral with the upper self - closing valve or the lower self - closing valve, or are connected together by bonding or welding with different materials.

19. The self - closing system according to claim 18, wherein: The left sealing strip and the right sealing strip are respectively adhered to the balloon.

20. The self - closing system according to claim 19, wherein: After combination, it is flipped through the hole on the upper main body. The upper main body and the lower main body form the balloon. The self - closing valve together with the inverted pocket and the sealing band at its distal end enter the interior of the balloon. One end of the catheter is outside the balloon and the other end is inside the inverted pocket. Finally, the hole on the upper main body is sealed with a patch.

21. A method for manufacturing the self - closing system according to claim 1, wherein the balloon body comprises an upper main body and a lower main body, and the self - closing valve comprises an upper self - closing valve and a lower self - closing valve, wherein: While the upper main body and the lower main body are combined together at the edge by bonding or welding, three sides of the upper self - closing valve and the lower self - closing valve are bonded or welded together by a connecting band to form the self - closing valve. A small hole is opened on the lower self - closing valve. All or part of the lower self - closing valve and the upper inverted pocket film are bonded or welded together with the lower inverted pocket film by a connecting band to form the inverted pocket. The catheter penetrates through the unconnected ends of the upper self - closing valve and the lower self - closing valve and exits through the small hole and enters any position in the inverted pocket.

22. According to the method of claim 21, wherein: The sealing band is on the outer side of the inverted pocket and comprises an upper sealing strip and a lower sealing strip. The upper sealing strip is on the outer side of the upper inverted pocket film, and the lower sealing strip is on the outer side of the lower inverted pocket film. The sealing band is adhered to the balloon through the two ends of the upper sealing strip.

23. According to the method of claim 22, wherein: After combination, it is flipped through the hole on the upper main body. The upper main body and the lower main body form the balloon body. The self - closing valve together with the inverted pocket and the sealing band at its distal end enter the interior of the balloon body. One end of the catheter is outside the balloon and the other end is inside the inverted pocket. Finally, the hole on the upper main body is sealed with a patch.

24. According to the method of claim 21, wherein: The sealing band is on the outer side of the inverted pocket and comprises an upper sealing strip and a lower sealing strip. The upper sealing strip is on the outer side of the upper inverted pocket film, and the lower sealing strip is on the outer side of the lower inverted pocket film. The sealing band is adhered to the balloon through the two ends of the lower sealing strip.

25. According to the method of claim 24, wherein: After combination, it is flipped through the hole on the upper main body. The upper main body and the lower main body form the balloon body. The self - closing valve together with the inverted pocket and the sealing band at its distal end enter the interior of the balloon body. One end of the catheter is outside the balloon and the other end is inside the inverted pocket. Finally, the hole on the upper main body is sealed with a patch.

26. A method for manufacturing the self - closing system according to any one of claims 14 - 20, wherein the balloon comprises an upper main body and a lower main body, and the self - closing valve comprises an upper self - closing valve and a lower self - closing valve, It is characterized in that: Small holes are formed in the pocket film for making the inverted pocket, the perimeter of the small holes is not greater than the outer diameter of the catheter, the length of the pocket film is not greater than the length of the upper self-sealing valve, and the sealing strip includes a left sealing strip and a right sealing strip, which are respectively on both sides of the distal end of the upper self-sealing valve or the lower self-sealing valve.

27. A balloon system, comprising the self-sealing system according to any one of claims 1-13, or the self-sealing system according to any one of claims 14-20, or the self-sealing system obtained by the method according to any one of claims 21-25, or the self-sealing system obtained by the method according to claim 26.

28. The balloon system according to claim 27, It is characterized in that: The balloon system is an intragastric balloon system.

29. The balloon system according to claim 28, It is characterized in that: The balloon system is a skin expansion balloon system.

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