A self-sealing valve structure for an implantable balloon system

Abstract

The present application discloses a self-closing valve structure for implanting a balloon system. The balloon system includes a balloon, a catheter and a filler. The self-closing valve is located at any position on the balloon, is passed through by a catheter and is sealingly connected to the catheter, and the interior of the self-closing valve has at least one baffle. The self-closing valve baffle can form a Y-shape, an eight-shape, a straight or curved line segment and the like. The catheter passes through a small hole in the side wall of the self-closing valve or a distal hole of the self-closing valve, and the diameter of the small hole or the diameter of the distal hole of the self-closing valve is not greater than the outer diameter of the catheter. After swallowing a capsule containing a balloon and part of the catheter, the capsule dissolves rapidly in the gastric environment, and the filler is transported into the balloon through the extracorporeal end of the catheter. After the catheter is pulled out, the baffle makes the upper self-closing valve and the lower self-closing valve fit together, effectively blocking the leakage of the filler fluid and preventing the leakage of the filler in the balloon.

Description

Technical Field

[0001] The present application relates to a self-sealing valve structure of an implantable balloon system. Background Art

[0002] Over the past 20 years, the incidence of obesity has soared worldwide, including adult obesity, obesity in the elderly, and obesity in adolescents and children. 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 in 2014, there were nearly one billion obese adults in the world. What is not optimistic is that China's obese population has surpassed the United States. In 2016, there were 89.6 million obese people in China (the obese population in the United States was 87.8 million), of which 43.2 million were males and 46.4 million were females. Obesity is often accompanied by hypertension, type II diabetes, ischemic heart disease, dyslipidemia, joint degeneration, sleep apnea and certain tumors. Therefore, how to effectively control weight and prevent and control the occurrence of complications is a topic of great concern.

[0003] At present, the main treatments for obesity include: diet control, lifestyle intervention, drug therapy and surgical treatment. However, simple diet control, lifestyle intervention and drug therapy are difficult to achieve satisfactory weight loss results; although weight loss surgery is effective, it is difficult for patients to accept it due to cultural, 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 its safety, simplicity, effectiveness and recoverability, it has received widespread attention and will become the main effective means of weight loss in the future.

[0004] At present, several types of intragastric balloons have been launched in foreign countries, especially those that can be swallowed by oneself without gastroscopy, which is the direction of future weight loss methods. The swallowable intragastric balloon is wrapped in a capsule before use and is connected to a longer catheter. One end of the catheter is connected to the self-sealing valve on the intragastric balloon, and the other end remains outside the mouth. The balloon and part of the catheter wrapped in the capsule are delivered into the patient's stomach by swallowing. The capsule is rapidly degraded in the gastric acid environment, and the filler is delivered to the balloon from the external end of the catheter that remains outside the patient's mouth. The balloon expands from the initial compressed state to the expanded state. After the delivery of the filler, the catheter is pulled out of 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 out.

[0005] US Patent No. 8974483B2 discloses a connection and release structure between a catheter and a balloon, as shown in the attached Figure 1As shown. This catheter and balloon connection and release structure includes a catheter 1100 and two layers of self-sealing valves 1110 sealed along the edge. The self-sealing valve 1110 can be positioned in a hole on the surface of the material of the upper part 1014 or the lower part 1016 of the balloon or in the opening of the seam 1004 of the upper part 1014 and the lower part 1016. The catheter 1100 enters the balloon from the outside of the balloon through the channel 1020 between the two layers of self-sealing valves 1110. After the filling material is transported into the balloon, the catheter 1100 is pulled out, and the channel 1020 between the two layers of self-sealing valves 1110 is automatically closed to prevent the filling material in the balloon from leaking out.

[0006] The disadvantage of this structure is that after the catheter 1100 is pulled out, the channel 1020 may not be completely closed in time, and there is a risk of leakage of the filling material. Summary of the invention

[0007] In order to solve the above technical problems, the present application provides a novel self-sealing valve structure of an implantable balloon system, which has a good sealing effect after the catheter is pulled out from the balloon to prevent leakage of the filling material.

[0008] The present application provides a self-closing valve structure for a balloon system, wherein the balloon system comprises a balloon, a catheter and a filler, wherein the self-closing valve is located at any position on the balloon, is passed through by a catheter and is sealingly connected to the catheter, and is characterized in that: there is at least one baffle plate inside the self-closing valve.

[0009] Preferably, the baffle forms a Y-shape, an eight-shape, a straight line segment or a curved line segment.

[0010] Preferably, the balloon includes an upper balloon and a lower balloon, the self-closing valve includes an upper self-closing valve, a lower self-closing valve and the baffle, a small hole is opened on the side wall of the lower self-closing valve, the diameter of the small hole is not larger than the outer diameter of the catheter, and the catheter passes through the small hole on the side wall of the self-closing valve.

[0011] Preferably, the upper balloon and the upper self-sealing valve are combined with the lower balloon and the lower self-sealing valve at the edge by bonding or welding. After the balloons are assembled, they are flipped through the hole on the upper balloon, and the self-sealing valve enters the interior of the balloon by flipping. The catheter is inserted from the outside of the balloon into the channel cavity between the upper self-sealing valve and the lower self-sealing valve, and passes out from the small hole on the lower self-sealing valve to enter the interior of the balloon. Finally, the hole on the upper balloon is closed with a patch.

[0012] Preferably, the balloon includes an upper balloon and a lower balloon, the self-closing valve includes an upper self-closing valve, a lower self-closing valve, a patch and the baffle, a small hole is opened on the lower self-closing valve, the diameter of the small hole on the lower self-closing valve is not larger than the outer diameter of the catheter, and the catheter passes through the small hole on the side wall of the self-closing valve.

[0013] Preferably, a small hole is formed on the patch, the diameter of the small hole on the patch is not larger than the outer diameter of the catheter, and the position of the small hole on the patch is staggered with the position of the small hole on the lower self-sealing valve.

[0014] Preferably, the upper balloon and the upper self-sealing valve are combined with the lower balloon and the lower self-sealing valve at the edge by bonding or welding. After the balloons are assembled, they are flipped over through the hole on the upper balloon, and the self-sealing valve enters the interior of the balloon by flipping over. The catheter passes through the channel of the patch and the upper self-sealing valve, passes out from the small hole of the patch and the small hole of the lower self-sealing valve, enters the interior of the balloon, and finally the hole on the upper balloon is closed with a patch.

[0015] Preferably, the patch is an impermeable polymer material.

[0016] Preferably, the balloon comprises an upper balloon and a lower balloon, the self-closing valve comprises an upper self-closing valve, a lower self-closing valve and the baffle, a small hole is opened at the distal end of the lower self-closing valve, the diameter of the small hole is not larger than the outer diameter of the catheter, and the catheter passes through the small hole at the distal end of the self-closing valve.

[0017] Preferably, the upper balloon and the upper self-sealing valve are combined with the lower balloon and the lower self-sealing valve at the edge by bonding or welding. When assembling the self-sealing valve, a small hole is retained at the distal end, and the diameter of the small hole is no larger than the outer diameter of the catheter. After the balloon assembly is completed, the balloon is flipped through the hole on the upper balloon, and the self-sealing valve enters the interior of the balloon by flipping. The catheter is inserted from the outside of the balloon into the channel cavity between the upper self-sealing valve and the lower self-sealing valve, and passes out from the small hole at the distal end of the self-sealing valve to enter the interior of the balloon. Finally, the hole on the upper balloon is closed with a patch.

[0018] Preferably, the baffle may be formed by gluing, welding, heat sealing or other methods.

[0019] Preferably, the self-closing valve is composed of two or more layers of impermeable materials.

[0020] The present application provides a method for manufacturing a self-sealing valve structure for a balloon system, comprising the following steps: providing an upper balloon and a lower balloon, combining the upper balloon and the upper self-sealing valve with the lower balloon and the lower self-sealing valve at their edges by bonding or welding, the upper balloon and the lower balloon forming a balloon, a baffle, the lower self-sealing valve and the upper self-sealing valve forming a self-sealing valve, flipping the balloon through a hole on the upper balloon after the balloon is assembled, the self-sealing valve entering the interior of the balloon through the flipping, inserting a catheter from the outside of the balloon into a channel cavity between the upper self-sealing valve and the lower self-sealing valve, and passing through a small hole on the lower self-sealing valve to enter the interior of the balloon, and finally sealing the hole on the upper balloon with a patch.

[0021] 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, and the catheter has a certain length so that the external end remains outside the oral cavity during use.

[0022] Preferably, the upper self-sealing valve and the upper balloon are integrally formed, or are made of different materials connected together by gluing or welding.

[0023] Preferably, the lower self-sealing valve and the lower balloon are integrally formed, or are made of different materials and connected together by bonding or welding.

[0024] The present application also provides a method for manufacturing a self-sealing valve structure for a balloon system, comprising the following steps: providing an upper balloon and a lower balloon, combining the upper balloon and the upper self-sealing valve with the lower balloon and the lower self-sealing valve at the edge by bonding or welding, the upper balloon and the lower balloon form a balloon, the baffle, the patch, the lower self-sealing valve and the upper self-sealing valve form a self-sealing valve, after the balloon is assembled, the balloon is flipped through the hole on the upper balloon, the self-sealing valve enters the interior of the balloon through the flipping, the catheter passes through the channel of the patch and the upper self-sealing valve, passes through the small hole of the patch and the small hole of the lower self-sealing valve, enters the interior of the balloon, and finally the hole on the upper balloon is closed with a patch.

[0025] 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, and the catheter has a certain length so that the external end remains outside the oral cavity during use.

[0026] Preferably, the upper self-sealing valve and the upper balloon are integrally formed, or are made of different materials connected together by gluing or welding.

[0027] Preferably, the lower self-sealing valve and the lower balloon are integrally formed, or are made of different materials and connected together by bonding or welding.

[0028] The present application also provides a method for manufacturing a self-sealing valve structure for a balloon system, comprising the following steps: providing an upper balloon and a lower balloon, combining the upper balloon and the upper self-sealing valve with the lower balloon and the lower self-sealing valve at the edge by bonding or welding, the upper balloon and the lower balloon form a balloon, the baffle, the lower self-sealing valve and the upper self-sealing valve form a self-sealing valve, a small hole is retained at the distal end when the self-sealing valve is assembled, the diameter of the small hole is not greater than the outer diameter of the catheter, after the balloon assembly is completed, the balloon is flipped through the hole on the upper balloon, the self-sealing valve enters the interior of the balloon through the flipping, the catheter is inserted from the outside of the balloon into the channel cavity between the upper self-sealing valve and the lower self-sealing valve, and passes out from the small hole at the distal end of the self-sealing valve to enter the interior of the balloon, and finally the hole on the upper balloon is closed with a patch.

[0029] 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, and the catheter has a certain length so that the external end remains outside the oral cavity during use.

[0030] Preferably, the upper self-sealing valve and the upper balloon are integrally formed, or are made of different materials connected together by gluing or welding.

[0031] Preferably, the lower self-sealing valve and the lower balloon are integrally formed, or are made of different materials and connected together by bonding or welding.

[0032] The self-sealing valve structure of the present application is not limited to use in intragastric balloon systems, but can also be used in other balloon implants, such as skin expansion balloons, etc.

[0033] The self-sealing valve structure of the present application has a baffle inside the valve that effectively blocks the leakage path of the filling fluid after the balloon is filled and the catheter is pulled out, forming a good self-sealing structure to prevent leakage of the filling material. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 It is a schematic diagram of the connection and release structure of the catheter and the balloon according to the prior art;

[0035] Figure 2 This is a schematic diagram of the balloon of the Y-type valve according to the first embodiment of the present application;

[0036] Figure 3 This is a schematic diagram of the exploded view of the Y-shaped valve balloon after flipping according to the first embodiment of the present application;

[0037] Figure 4 This is a schematic diagram of the balloon state after the catheter is removed according to the first embodiment of the present application;

[0038] Figure 5 This is a schematic diagram of an exploded view of an eight-shaped valve balloon according to a second embodiment of the present application;

[0039] Figure 6 This is a schematic diagram of an exploded view of a figure-eight valve balloon after flipping according to a second embodiment of the present application;

[0040] Figure 7 It is a schematic diagram of the state of the balloon after the catheter is removed according to the second embodiment of the present application;

[0041] Figure 8 This is a schematic diagram of an exploded view of a straight-valve balloon according to a third embodiment of the present application;

[0042] Fig. 9 This is a schematic diagram of an exploded view of a straight-valve balloon after flipping according to a third embodiment of the present application;

[0043] Fig.10 This is a schematic diagram of the state of the balloon after the catheter is removed according to the third embodiment of the present application;

[0044] Fig.11 This is an exploded schematic diagram of a Y-shaped three-layer valve balloon according to a fourth embodiment of the present application;

[0045] Fig.12 This is a schematic diagram of an exploded view of a Y-shaped three-layer valve balloon after flipping according to the fourth embodiment of the present application;

[0046] Fig.13 This is a schematic diagram of the state of the balloon after the catheter is removed according to the fourth embodiment of the present application. DETAILED DESCRIPTION

[0047] The technical solutions in the embodiments of the present application are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments of the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present application.

[0048] Attached Figure 2-4 It is a schematic diagram of the decomposition of the Y-type valve balloon of the first embodiment of the present application, wherein the balloon 100 includes an upper balloon 120 and a lower balloon 110, and the self-sealing valve 300 includes an upper self-sealing valve 320, a lower self-sealing valve 310 and a Y-type baffle 4, wherein the lower self-sealing valve 310 is provided with a small hole 311, and the diameter of the small hole 311 is not greater than the outer diameter of the catheter 200. The upper self-sealing valve 320 and the upper balloon 120 can be a whole, or they can be connected together by gluing or welding of different materials. Similarly, the lower self-sealing valve 310 and the lower balloon 110 can be a whole, or they can be connected together by gluing or welding of different materials. The baffle 4 between the lower self-sealing valve 310 and the upper self-sealing valve 320 is formed by gluing, heat sealing or welding. The upper layer balloon 120 and the upper layer self-sealing valve 320 are combined with the lower layer balloon 110 and the lower layer self-sealing valve 310 at the edge 3 by bonding or welding, and the upper layer balloon 120 and the lower layer balloon 110 form the balloon 100, and the Y-shaped baffle 4, the lower layer self-sealing valve 310 and the upper layer self-sealing valve 320 form the self-sealing valve 300. After the balloon is assembled, it is turned over through the hole 2 on the upper layer balloon 120, and the exploded diagram after turning over is as shown in FIG. Figure 3As shown, the self-sealing valve 300 is turned over to enter the interior of the balloon 100. The catheter 200 is passed from the outside of the balloon 100 into the channel cavity 130 between the upper self-sealing valve 320 and the lower self-sealing valve 310, and passes out from the small hole 311 on the lower self-sealing valve 310 to enter the interior of the balloon 100, and finally the hole 2 on the upper balloon 120 is sealed with a patch.

[0049] The balloon 100 is wrapped in a capsule before swallowing, one end of the catheter 200 (i.e., the in-vivo end) is connected to the self-sealing valve 300 on the balloon 100, and the other end (i.e., the in-vivo end) remains outside the capsule. The catheter 200 has a certain length so that the in-vivo end remains outside the oral cavity during use.

[0050] After the patient swallows the capsule containing the balloon 100 and part of the catheter 200, the capsule dissolves rapidly in the stomach environment, and the filling material is transported into the balloon 100 through the external end of the catheter 200. The diameter of the small hole 311 on the lower self-sealing valve 310 is not larger than the outer diameter of the catheter, which effectively prevents leakage during the process of transporting the filling material. After the catheter 200 is pulled out, the Y-shaped baffle 4 makes the upper self-sealing valve 320 and the lower self-sealing valve 310 fit together, and at the same time effectively blocks the filling material outflow channel 130, thereby preventing the leakage of the filling material in the balloon. Figure 4 The balloon state after the catheter is removed is shown. The balloon 100 occupies the volume in the stomach for a long time, thereby achieving the purpose of weight loss.

[0051] Attached Figure 5-7 It is a schematic diagram of the decomposition of the figure-eight valve balloon of the second embodiment of the present application, wherein the balloon 100 includes an upper balloon 120 and a lower balloon 110, and the self-sealing valve 300 includes an upper self-sealing valve 320, a lower self-sealing valve 310 and a figure-eight baffle 4, wherein the lower self-sealing valve 310 is provided with a small hole 311, and the diameter of the small hole 311 is not greater than the outer diameter of the catheter 200. The upper self-sealing valve 320 and the upper balloon 120 can be a whole, or they can be connected together by gluing or welding of different materials. Similarly, the lower self-sealing valve 310 and the lower balloon 110 can be a whole, or they can be connected together by gluing or welding of different materials. The baffle 4 between the lower self-sealing valve 310 and the upper self-sealing valve 320 is formed by gluing, heat sealing or welding. The upper layer balloon 120 and the upper layer self-sealing valve 320 are combined with the lower layer balloon 110 and the lower layer self-sealing valve 310 at the edge 3 by bonding or welding, and the upper layer balloon 120 and the lower layer balloon 110 form the balloon 100, and the eight-shaped baffle plate 4, the lower layer self-sealing valve 310 and the upper layer self-sealing valve 320 form the self-sealing valve 300. After the balloon is assembled, it is turned over through the hole 2 on the upper layer balloon 120, and the exploded diagram after turning over is as shown in FIG. Figure 6As shown, the self-sealing valve 300 is turned over to enter the interior of the balloon 100. The catheter 200 is passed from the outside of the balloon 100 into the channel cavity 130 between the upper self-sealing valve 320 and the lower self-sealing valve 310, and passes out from the small hole 311 on the lower self-sealing valve 310 to enter the interior of the balloon 100, and finally the hole 2 on the upper balloon 120 is sealed with a patch.

[0052] The balloon 100 is wrapped in a capsule before swallowing, one end of the catheter 200 (i.e., the in-vivo end) is connected to the self-sealing valve 300 on the balloon 100, and the other end (i.e., the in-vivo end) remains outside the capsule. The catheter 200 has a certain length so that the in-vivo end remains outside the oral cavity during use.

[0053] After the patient swallows the capsule containing the balloon 100 and part of the catheter 200, the capsule dissolves rapidly in the stomach environment, and the filling material is transported into the balloon 100 through the external end of the catheter 200. The diameter of the small hole 311 on the lower self-sealing valve 310 is not larger than the outer diameter of the catheter, which effectively prevents leakage during the process of transporting the filling material. After the catheter 200 is pulled out, the eight-shaped baffle plate 4 makes the upper self-sealing valve 320 and the lower self-sealing valve 310 fit together, and at the same time effectively blocks the filling material outflow channel 130, thereby preventing the leakage of the filling material in the balloon. Figure 7 The balloon state after the catheter is removed is shown. The balloon 100 occupies the volume in the stomach for a long time, thereby achieving the purpose of weight loss.

[0054] Attached Figure 8-10 It is a schematic diagram of the decomposition of the straight-valve balloon of the third embodiment of the present application, wherein the balloon 100 includes an upper balloon 120 and a lower balloon 110, and the self-sealing valve 300 includes an upper self-sealing valve 320, a lower self-sealing valve 310 and a straight-shaped baffle 4. The straight-shaped baffle can be a straight line segment or an arc segment. The upper self-sealing valve 320 and the upper balloon 120 can be a whole, or they can be connected together by gluing or welding of different materials. Similarly, the lower self-sealing valve 310 and the lower balloon 110 can be a whole, or they can be connected together by gluing or welding of different materials. The baffle 4 between the lower self-sealing valve 310 and the upper self-sealing valve 320 is formed by gluing, heat sealing or welding. The upper balloon 120 and the upper self-sealing valve 320 are combined with the lower balloon 110 and the lower self-sealing valve 310 at the edge 3 by bonding or welding. The upper balloon 120 and the lower balloon 110 form the balloon 100, and the I-shaped baffle 4, the lower self-sealing valve 310 and the upper self-sealing valve 320 form the self-sealing valve 300. When assembling the self-sealing valve 300, a small hole 341 is retained at the distal end, and the diameter of the small hole 341 is not greater than the outer diameter of the catheter. After the balloon is assembled, it is flipped through the hole 2 on the upper balloon 120. The exploded diagram after flipping is as shown in FIG. Fig. 9As shown, the self-sealing valve 300 is turned over to enter the interior of the balloon 100. The catheter 200 is passed from the outside of the balloon 100 into the channel cavity 130 between the upper self-sealing valve 320 and the lower self-sealing valve 310, and passes out from the small hole 341 at the distal end of the self-sealing valve to enter the interior of the balloon 100, and finally the hole 2 on the upper balloon 120 is closed with a patch.

[0055] The balloon 100 is wrapped in a capsule before swallowing, one end of the catheter 200 (i.e., the in-vivo end) is connected to the self-sealing valve 300 on the balloon 100, and the other end (i.e., the in-vivo end) remains outside the capsule. The catheter 200 has a certain length so that the in-vivo end remains outside the oral cavity during use.

[0056] After the patient swallows the capsule containing the balloon 100 and part of the catheter 200, the capsule dissolves rapidly in the stomach environment, and the filling material is transported into the balloon 100 through the external end of the catheter 200. The diameter of the small hole 341 at the distal end of the self-sealing valve 300 is not larger than the outer diameter of the catheter, which effectively prevents leakage during the process of transporting the filling material. After the catheter 200 is pulled out, the straight-line baffle 4 makes the upper self-sealing valve 320 and the lower self-sealing valve 310 fit together, and at the same time effectively blocks the filling material outflow channel 130, thereby preventing the leakage of the filling material in the balloon. Fig.10 The balloon state after the catheter is removed is shown. The balloon 100 occupies the volume in the stomach for a long time, thereby achieving the purpose of weight loss.

[0057] Attached Figure 11-13It is a schematic diagram of the decomposition of the Y-type three-layer valve balloon of the fourth embodiment of the present application, wherein the balloon 100 includes an upper balloon 120 and a lower balloon 110, and the self-sealing valve 300 includes an upper self-sealing valve 320, a lower self-sealing valve 310, a patch 330 and a Y-type baffle 4. A small hole 311 is provided on the lower self-sealing valve 310, and the diameter of the small hole 311 is not greater than the outer diameter of the catheter. The patch 330 can be an impermeable polymer material or other material. A small hole 331 is provided on the patch 330, and the diameter of the small hole 331 is not greater than the outer diameter of the catheter, and the position of the small hole 331 is staggered with the position of the small hole 311 on the lower self-sealing valve 310. The upper self-sealing valve 320 and the upper balloon 120 can be a whole, or they can be connected together by gluing or welding of different materials. Similarly, the lower self-sealing valve 310 and the lower balloon 110 can be a whole, or they can be made of different materials connected together by bonding or welding. The Y-shaped baffle 4 between the patch 330 and the upper self-sealing valve 320 is formed by gluing, heat sealing or welding. The upper balloon 120 and the upper self-sealing valve 320 are combined with the lower balloon 110 and the lower self-sealing valve 310 at the edge 3 by bonding or welding, and the upper balloon 120 and the lower balloon 110 form the balloon 100, and the Y-shaped baffle 4, the patch 330, the lower self-sealing valve 310 and the upper self-sealing valve 320 form the self-sealing valve 300. After the balloon is assembled, it is flipped through the hole 2 on the upper balloon 120, and the decomposition diagram after flipping is shown as follows. Fig.12 As shown, the self-sealing valve 300 enters the interior of the balloon 100 by turning over. The catheter passes through the patch 330 and the channel 130 of the upper self-sealing valve 320, passes through the patch hole 331 and the lower self-sealing valve hole 311, enters the interior of the balloon 100, and finally closes the hole 2 on the upper balloon 120 with a patch.

[0058] The balloon 100 is wrapped in a capsule before swallowing, one end of the catheter 200 (i.e., the in-vivo end) is connected to the self-sealing valve 300 on the balloon 100, and the other end (i.e., the in-vivo end) remains outside the capsule. The catheter 200 has a certain length so that the in-vivo end remains outside the oral cavity during use.

[0059] After the patient swallows the capsule containing the balloon 100 and part of the catheter 200, the capsule dissolves rapidly in the stomach environment, and the filling material is transported into the balloon 100 through the external end of the catheter 200. The diameter of the small hole 311 on the lower self-sealing valve 310 is not larger than the outer diameter of the catheter, which effectively prevents leakage during the process of transporting the filling material. After the catheter 200 is pulled out, the small hole 331 of the patch 330 and the small hole 311 of the lower self-sealing valve 310 are misaligned and fitted, effectively preventing the filling material from entering the valve channel 130 from the small hole 311 of the lower valve. The Y-shaped baffle 4 fits the patch 330 and the upper self-sealing valve 320 together, and at the same time effectively blocks the filling material outflow channel 130, preventing the leakage of the filling material in the balloon. Fig.13 The balloon state after the catheter is removed is shown. The balloon 100 occupies the volume in the stomach for a long time, thereby achieving the purpose of weight loss.

[0060] Those skilled in the art can understand that the three self-sealing valve structures, including the valve side wall with a small hole, the valve distal end with a small hole, and the patch, are all suitable for Y-shaped, eight-shaped, and a line segment baffle. The above disclosures are only several preferred embodiments of the present application, and certainly cannot be used to limit the scope of the present application. Therefore, equivalent changes made according to the claims of the present application are still within the scope of the present application.

Claims

1. A self-sealing valve structure for a balloon system, the balloon system comprising a balloon, a catheter and a filler, the self-sealing valve being located at any position on the balloon, being passed through by a catheter and being sealingly connected to the catheter, characterized in that: The self-sealing valve has at least one baffle inside; the balloon includes an upper balloon and a lower balloon, the self-sealing valve includes an upper self-sealing valve, a lower self-sealing valve and the baffle, and a small hole is opened on the side wall or at the distal end of the lower self-sealing valve; The diameter of the small hole is not greater than the outer diameter of the catheter, and the catheter passes through the small hole on the side wall or the distal end of the self-sealing valve; The upper balloon and the upper self-sealing valve are combined with the lower balloon and the lower self-sealing valve at the edge by bonding or welding. After the balloons are assembled, they are turned over through the hole on the upper balloon, and the self-sealing valve enters the interior of the balloon by turning over. The catheter is inserted from the outside of the balloon into the channel cavity between the upper self-sealing valve and the lower self-sealing valve, and passes out from the small hole on the lower self-sealing valve to enter the balloon. Finally, the hole on the upper balloon is closed with a patch.

2. According to the self-closing valve structure of claim 1, the baffle forms a Y-shape, an eight-shape, a straight line segment or a curved line segment.

3. According to the self-closing valve structure of claim 2, the balloon comprises an upper balloon and a lower balloon, the self-closing valve comprises an upper self-closing valve, a lower self-closing valve, a patch and the baffle, a small hole is opened on the lower self-closing valve, the diameter of the small hole on the lower self-closing valve is not larger than the outer diameter of the catheter, and the catheter passes through the small hole on the side wall of the self-closing valve.

4. According to the self-closing valve structure of claim 3, a small hole is opened on the patch, the diameter of the small hole on the patch is not larger than the outer diameter of the catheter, and the position of the small hole on the patch is staggered with the position of the small hole on the lower self-closing valve.

5. According to the self-closing valve structure of claim 4, the upper balloon and the upper self-closing valve are combined with the lower balloon and the lower self-closing valve at the edge by bonding or welding. After the balloons are assembled, they are flipped through the hole on the upper balloon, and the self-closing valve enters the interior of the balloon by flipping. The catheter passes through the channel of the patch and the upper self-closing valve, passes through the small hole of the patch and the small hole of the lower self-closing valve, enters the interior of the balloon, and finally the hole on the upper balloon is closed with a patch. The self-closing valve structure according to claim 5 , wherein the patch is made of an impermeable polymer material.

7. According to the self-closing valve structure of claim 2, the upper balloon and the upper self-closing valve are combined with the lower balloon and the lower self-closing valve at the edge by bonding or welding, and a small hole is retained at the distal end when the self-closing valve is assembled, and the diameter of the small hole is not larger than the outer diameter of the catheter. After the balloon assembly is completed, the balloon is flipped through the hole on the upper balloon, and the self-closing valve enters the interior of the balloon by flipping. The catheter is inserted from the outside of the balloon into the channel cavity between the upper self-closing valve and the lower self-closing valve, and passes through the small hole at the distal end of the self-closing valve to enter the interior of the balloon, and finally the hole on the upper balloon is closed with a patch.

8. The self-closing valve structure according to any one of claims 1 to 7, wherein the baffle is formed by gluing, welding or heat sealing.

9. The self-closing valve structure according to any one of claims 1 to 7, wherein the self-closing valve is composed of two or more layers of impermeable materials.

10. A method for making a self-closing valve structure for a balloon system as described in any one of claims 1-2, comprising the following steps: providing an upper balloon and a lower balloon, combining the upper balloon and the upper self-closing valve with the lower balloon and the lower self-closing valve at the edge by bonding or welding, the upper balloon and the lower balloon form a balloon, the baffle, the lower self-closing valve and the upper self-closing valve form a self-closing valve, after the balloon is assembled, flipping the balloon through the hole on the upper balloon, the self-closing valve enters the interior of the balloon through the flipping, inserting a catheter from the outside of the balloon into the channel cavity between the upper self-closing valve and the lower self-closing valve, and passing through the small hole on the lower self-closing valve to enter the interior of the balloon, and finally sealing the hole on the upper balloon with a patch.

11. The method according to claim 10, wherein 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 so that the external end remains outside the oral cavity during use.

12. The method according to claim 10, wherein the upper self-sealing valve and the upper balloon are an integral unit, or are made of different materials and connected together by gluing or welding.

13. The method according to claim 10, wherein the lower self-sealing valve and the lower balloon are an integral unit, or are made of different materials and connected together by bonding or welding.

14. A method for making a self-closing valve structure for a balloon system as described in any one of claims 4 to 6, comprising the following steps: providing an upper balloon and a lower balloon, combining the upper balloon and the upper self-closing valve with the lower balloon and the lower self-closing valve at the edge by bonding or welding, the upper balloon and the lower balloon form a balloon, the baffle, the patch, the lower self-closing valve and the upper self-closing valve form a self-closing valve, after the balloon is assembled, it is flipped through the hole on the upper balloon, the self-closing valve enters the interior of the balloon by flipping, the catheter passes through the channel of the patch and the upper self-closing valve, passes through the small hole of the patch and the small hole of the lower self-closing valve, enters the interior of the balloon, and finally the hole on the upper balloon is closed with a patch.

15. The method according to claim 14, wherein 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 so that the external end remains outside the oral cavity during use.

16. The method according to claim 14, wherein the upper self-sealing valve and the upper balloon are integrally formed, or are made of different materials and connected together by gluing or welding.

17. The method according to claim 14, wherein the lower self-sealing valve and the lower balloon are integrally formed, or are made of different materials and connected together by bonding or welding.

18. A method for making the self-closing valve structure for a balloon system as described in claim 7, comprising the following steps: providing an upper balloon and a lower balloon, combining the upper balloon and the upper self-closing valve with the lower balloon and the lower self-closing valve at the edge by bonding or welding, the upper balloon and the lower balloon form a balloon, the baffle, the lower self-closing valve and the upper self-closing valve form a self-closing valve, a small hole is retained at the distal end when assembling the self-closing valve, the diameter of the small hole is not larger than the outer diameter of the catheter, after the balloon assembly is completed, the balloon is flipped through the hole on the upper balloon, the self-closing valve enters the interior of the balloon by flipping, the catheter is inserted from the outside of the balloon into the channel cavity between the upper self-closing valve and the lower self-closing valve, and passes through the small hole at the distal end of the self-closing valve to enter the interior of the balloon, and finally the hole on the upper balloon is sealed with a patch.

19. The method according to claim 18, wherein 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 so that the external end remains outside the oral cavity during use.

20. The method according to claim 18, wherein the upper self-sealing valve and the upper balloon are integrally formed, or are made of different materials and connected together by gluing or welding.

21. The method according to claim 18, wherein the lower self-sealing valve and the lower balloon are integrally formed, or are made of different materials and connected together by bonding or welding.

22. A balloon system, comprising the self-closing valve structure according to any one of claims 1 to 9 or the self-closing valve structure manufactured by the method according to any one of claims 10 to 21.

23. The balloon system of claim 22, which is an intragastric balloon system.

24. The balloon system of claim 22, wherein the balloon system is a skin dilation balloon system.

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