An adjustable balloon system and method of adjustment

Abstract

The application discloses an adjustable balloon system and an adjusting method, which comprise a balloon, a connecting catheter and a filling catheter; the adjustable balloon system further comprises a sealing cover and a facilitator; two ends of the connecting catheter are respectively provided with a connecting end head and a pre-bent end head, one end of the connecting catheter close to the pre-bent end head is connected with the balloon, the pre-bent end head is located in the inner cavity of the balloon, and a self-closing sealing plug is sleeved on one end of the pre-bent end head; the filling catheter and the sealing cover can be movably disassembled with the connecting end head of the connecting catheter; two ends of the filling catheter are respectively connected with a luer joint and a three-way stop valve, and the facilitator is sleeved outside the balloon and the connecting catheter in the compressed state of the balloon. The application can adjust the stable placement of the balloon system and the volume adjustment after implantation according to the self needs of patients, so as to adjust the weight loss effect, realize the quantitative correction of diet, ensure the accurate control of weight loss, meet the different weight loss needs of different user groups and improve the applicability.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an adjustable balloon system and adjustment method. Background Technology

[0002] With the continuous development of society and the improvement of people's living standards, the obese population is also increasing. As people pay more attention to obesity, various weight loss methods have emerged. However, most of these methods are often not very effective. Therefore, people are increasingly hoping for a simple and effortless weight loss method that can help them lose weight quickly.

[0003] Scientific research shows that the root cause of obesity is energy intake exceeding energy expenditure. Calories primarily come from the energy-providing substances in ingested food. Therefore, scientific weight loss methods should directly or indirectly focus on reducing energy intake. Traditional weight loss methods such as medication, exercise, and surgery fail to achieve satisfactory results because they do not address the issue of reducing energy intake. Intragastric balloon placement is a novel weight loss method that increases satiety through balloon inflation, thereby reducing the user's energy intake. This method is gradually gaining attention. However, existing intragastric balloons often use a specific volume to ensure stability and safety, which imposes too many restrictions on users and makes them unsuitable for different patients, failing to meet the weight loss needs of diverse groups. Therefore, there is an urgent need for an adjustable balloon system and adjustment method to solve these problems. Summary of the Invention

[0004] The purpose of this invention is to provide an adjustable balloon system and adjustment method to solve the problems mentioned in the background art.

[0005] To achieve the above object, the solution of the present invention is: an adjustable balloon system, comprising a balloon, a connecting catheter and an infusion catheter; the adjustable balloon system further comprises a sealing cap and a promoter; the connecting catheter is a flexible catheter, and both ends of the connecting catheter are respectively provided with a connecting end and a pre-bent end, an auto-sealing sheet is provided at the connecting end, one end of the connecting catheter near the pre-bent end is connected to the balloon, the pre-bent end is located in the inner cavity of the balloon, and an auto-sealing plug is sleeved on one end of the pre-bent end; both the infusion catheter and the sealing cap can be detachably assembled with the connecting end of the connecting catheter; both ends of the infusion catheter are respectively connected with a Luer connector and a three-way stop valve, the infusion catheter is connected to the connecting end of the connecting catheter through the Luer connector, and the other two ports of the three-way stop valve are respectively connected with a syringe and a solution bag; the sealing cap is used for sealing the port of the connecting end of the connecting catheter after the infusion catheter is disassembled; the promoter is sleeved outside the balloon and the connecting catheter in the compressed state of the balloon, so that the balloon and the connecting catheter can be fixed at the end of the endoscope and sent into the stomach of the user through the promoter.

[0006] Further, the balloon is made of acid-resistant silicone elastomer, and the volume of the balloon is 400-700 ml.

[0007] Further, a sleeve is provided at the connecting end, a connecting hole is provided in the center of the sleeve, a joint end matching the connecting hole is provided on the Luer connector, and the auto-sealing sheet is arranged at the connecting hole for sealing the connecting hole; the auto-sealing sheet is made of elastic rubber or elastic silicone, an opening groove is provided in the center of the auto-sealing sheet, and the opening groove can be one of a "one" shape, a "cross" shape or a "rice" shape. The opening groove is in a sealed state under normal conditions and opens the opening groove after the joint end of the Luer connector is inserted, so that the connecting catheter and the infusion catheter are communicated with each other.

[0008] Furthermore, a connecting hole matching the bottom of the sleeve is provided at the top of the sealing cap, and a sealing gasket is provided in the connecting hole.

[0009] Further, the injection capacity of the syringe is 50-60 ml, and the injection end of the syringe is also connected with a Luer connector for connecting the three-way stop valve.

[0010] Furthermore, the self-closing sealing plug includes a shell, a spring, and a plug body; the shell is fitted onto the pre-bent end, and the shell has a flow guiding cavity inside, with at least one through hole on the outer side wall of the shell communicating with the flow guiding cavity; the plug body is slidably disposed inside the flow guiding cavity, and the spring is fixed to the top of the plug body and connected to the inner wall of the top of the flow guiding cavity, so that the plug body blocks the flow guiding cavity and the through hole under the action of the spring; the bottom of the plug body has a first flow guiding hole, and the outer side wall of the plug body has at least one second flow guiding hole corresponding to the position of the through hole, which communicates with the first flow guiding hole. When the spring is compressed or stretched, the through hole can communicate with the flow guiding cavity through the first and second flow guiding holes on the plug body.

[0011] Furthermore, the promoter has a cavity in the center for accommodating the balloon, and one end of the promoter is a pointed tip for connecting to an endoscope.

[0012] The present invention also provides an adjustment method for an adjustable balloon system, applied to the adjustable balloon system described above, comprising the following steps:

[0013] S1. Perform preparations for the endoscopy examination according to hospital procedures and take conscious sedation measures on the patient;

[0014] S2. Perform an endoscopic examination on the patient to assess whether there are any contraindications or other medical conditions;

[0015] S3. Remove the endoscope and clean it thoroughly according to hospital procedures. Then remove the adjustable balloon system from the packaging, disassemble each component in turn, and place them one by one on the operating platform.

[0016] S4. Secure the facilitator to the distal end of the endoscope and place the uninflated balloon and connecting catheter inside the facilitator, with the end of the balloon protruding 3mm beyond the facilitator tip. Position the connecting catheter at the proximal end port of the facilitator. Then, connect the inflation catheter to the connecting catheter tip via a Luer connector, ensuring the Luer connector is firmly inserted into the connecting tip. Next, apply medical lubricating gel or other lubricant to the entire outer side of the facilitator. Insert the endoscope and the facilitator containing the balloon and connecting catheter as a whole into the patient's throat and advance it into the esophagus and stomach using the standard endoscope insertion method.

[0017] S5. After the endoscope reaches the stomach, connect the other two ports of the three-way shut-off valve on the filling catheter to the syringe and the solution bag respectively, and then inject 500ml of gas or liquid into the balloon. Then pull the endoscope proximally to confirm whether the balloon has been released from the promoter.

[0018] S6. Place the endoscope tip on one side of the connecting catheter in the middle of the esophagus, then pull out the filling catheter to separate the filling catheter from the connecting catheter. Then fix the sealing cap to the connecting end of the connecting catheter to seal it. After sealing, push the balloon and the connecting catheter with the sealing cap into the stomach through the endoscope tip, remove the endoscope, and complete the intragastric implantation of the adjustable balloon system.

[0019] S7. After ensuring that the adjustable balloon system is fully implanted, check with an endoscope to confirm whether the balloon and connecting catheter are leaking. If everything is normal, use the endoscope to capture the connecting end of the connecting catheter and pull the connecting end to the endoscope tip. Pull the connecting end up by moving the endoscope, then remove the sealing cap, reinsert the inflation catheter, and connect the inflation catheter to the connecting end of the connecting catheter through the Luer connector. Then release the inflation catheter and let it slowly slide into the larynx.

[0020] S8. Observe the position of the balloon in the stomach through the endoscope to confirm that the balloon, connecting catheter, and filling catheter are not twisted or folded. If twisting or folding occurs, use the tip of the endoscope to pull the filling catheter to untwist it. Then connect the other two ports of the three-way shut-off valve on the filling catheter to the syringe and solution bag respectively to replenish or release the gas or liquid injected into the balloon until the gas or liquid in the balloon reaches the appropriate volume. Then repeat step S6 to separate the filling catheter from the connecting catheter and connect the sealing cap to the connecting catheter. Finally, remove the endoscope.

[0021] Furthermore, in step S5, if the balloon encounters any resistance during inflation or inflation, the endoscope needs to be repositioned until the gas or liquid can flow easily and then the process stops.

[0022] Furthermore, when the adjustable balloon system needs to be removed, the status of the balloon and connecting catheter can be checked by endoscopy. In step S7, the sealing cap is replaced with an inflatable catheter. Then, in step S8, the gas or liquid inside the balloon is emptied. Finally, the balloon is grasped with grasping forceps or clamps so that it is pressed against the tip of the endoscope, and the balloon is removed from the patient's esophagus through the endoscope.

[0023] The advantages of this invention compared to the prior art are:

[0024] (1) The present invention expands by inserting a balloon, which can occupy the stomach space in the human stomach, thereby making the user feel full, thereby reducing food intake and achieving the effect of weight loss.

[0025] (2) After the filling catheter is connected to the connecting catheter through the Luer connector, the balloon can adjust its own volume through the syringe and solution bag connected to the other two ports of the three-way shut-off valve after it is placed in the stomach. This allows users to adjust the weight loss effect according to their own needs, realize quantitative correction of diet, ensure precise control of weight loss, meet the different weight loss needs of different users, and improve applicability.

[0026] (3) By setting a sealing cap, the present invention can ensure that the gas or liquid injected into the balloon will not leak from the connecting tube end after the filling catheter is disassembled, thereby ensuring the stable use of the balloon.

[0027] (4) By using self-closing sealing plugs and self-closing sealing sheets at the connecting end and pre-bent end of the connecting catheter, the present invention can enable the connecting catheter to have a certain degree of sealing before the sealing cap is used, reducing the possibility of gas or liquid leakage in the balloon and further improving the stability of the balloon during use.

[0028] (5) The present invention, through the setting of the promoter, can make the balloon wrap around the balloon and the connecting catheter in a compressed state, so that after the promoter is connected to the endoscope, the balloon can be placed as the endoscope moves, which is conducive to the insertion of the balloon into the stomach, reduces the implantation risk, and reduces the pain of the patient during implantation.

[0029] (6) The adjustment method of the present invention is applied to the adjustable balloon system, which can realize the stable placement of the adjustable balloon system and the volume adjustment after placement, and can meet the different weight loss needs of different users, and has a wider range of applications. Attached Figure Description

[0030] Figure 1 This is a front view of the adjustable balloon system of the present invention after the balloon is connected to the inflation catheter in the compressed state.

[0031] Figure 2 This is a frontal cross-sectional view of the adjustable balloon system of the present invention after the balloon is connected to the inflation catheter in the balloon inflation state;

[0032] Figure 3 This is a front cross-sectional view of the adjustable balloon system of the present invention after the balloon is connected to the sealing cap in the inflated state.

[0033] Figure 4 For the present invention Figure 2 Enlarged structural diagram at point A in the middle;

[0034] Figure 5 For the present invention Figure 3 Enlarged structural diagram at point B;

[0035] Figure 6This is a partial cross-sectional structural diagram of the connection between the pre-bent end and the self-closing sealing plug of the present invention.

[0036] Figure 7 This is a bottom view of the connection between the sleeve and the self-closing sealing sheet of the present invention.

[0037] Figure 8 This is a three-dimensional structural diagram of the accelerator of the present invention.

[0038] The attached diagram lists the components represented by each number as follows:

[0039] 1. Balloon; 2. Connecting tubing; 21. Connecting end; 211. Sleeve; 212. Connecting hole; 22. Pre-bent end; 3. Luer connector; 31. Connector end; 4. Injection tubing; 5. Three-way shut-off valve; 6. Self-closing sealing plug; 61. Outer shell; 611. Through hole; 62. Spring; 63. Plug body; 631. Guide hole one; 632. Guide hole two; 7. Sealing cap; 71. Sealing gasket; 8. Promoter; 9. Self-closing sealing plate; 91. Opening groove. Detailed Implementation

[0040] Embodiments of the present invention are described in detail below, examples of which are illustrated in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain the present invention, and should not be construed as limiting the present invention.

[0041] Example 1:

[0042] like Figure 1-8As shown, an adjustable balloon system includes a balloon 1, a connecting catheter 2, and an inflation catheter 4; the adjustable balloon system also includes a sealing cap 7 and an facilitator 8; the connecting catheter 2 is a flexible catheter, with a connecting end 21 and a pre-bent end 22 at both ends, respectively. A self-closing sealing piece 9 is provided at the connecting end 21. The end of the connecting catheter 2 near the pre-bent end 22 is connected to the balloon 1, and the pre-bent end 22 is located within the cavity of the balloon 1. A self-closing sealing plug 6 is fitted onto one end of the pre-bent end 22; both the inflation catheter 4 and the sealing cap 7 can be detached from the connecting end 21 of the connecting catheter 2; the inflation catheter 4... The two ends of the balloon 1 are connected to a Luer connector 3 and a three-way shut-off valve 5, respectively. The filling catheter 4 is connected to the connecting end 21 of the connecting catheter 2 via the Luer connector 3. The other two ports of the three-way shut-off valve 5 are connected to a syringe and a solution bag, respectively. The sealing cap 7 is used to seal the connecting end 21 of the connecting catheter 2 after the filling catheter 4 is disassembled. The promoter 8 is fitted on the outside of the balloon 1 and the connecting catheter 2 when the balloon 1 is compressed, so that the balloon 1 and the connecting catheter 2 can be fixed to the end of the endoscope and inserted into the user's stomach through the promoter 8. The balloon 1 can be inflated by its own inflation or fluid filling (the injected fluid is physiological saline). When the balloon 1 is placed... After being inserted into the stomach, the balloon 1 can move freely and expand to occupy stomach space, thus creating a feeling of fullness and reducing food intake to achieve weight loss. The filling catheter 4, connected to the connecting catheter 2 via the Luer connector 3, allows the balloon 1 to adjust its volume after insertion into the stomach via the syringe and solution bag connected to the other two ports of the three-way shut-off valve 5. This allows users to adjust the weight loss effect according to their needs, achieving quantitative correction of diet and ensuring precise weight control, meeting the different weight loss needs of different users and improving applicability. The sealing cap 7 ensures that the balloon 1 remains intact after disassembly. The gas or liquid injected into balloon 1 will not leak from the connecting catheter 2, thus ensuring the stable use of balloon 1; the self-closing sealing plug 6 and self-closing sealing sheet 9 allow the connecting catheter 2 to have a certain degree of sealing even before the sealing cap 7 is used, reducing the possibility of gas or liquid leakage from balloon 1 and further improving the stability of balloon 1 during use; the facilitator 8 allows balloon 1 to wrap around balloon 1 and connecting catheter 2 in a compressed state, so that after the facilitator 8 is connected to the endoscope, it can move with the endoscope to place balloon 1, which is conducive to the gastric insertion of balloon 1, reduces the implantation risk, and reduces the pain of patients during implantation;

[0043] In a specific implementation manner of this embodiment, the balloon 1 is prepared from acid-resistant silicone elastomer, and the volume of the balloon 1 is 400 - 700 ml; among them, the balloon 1 prepared from acid-resistant silicone elastomer has good elasticity and acid resistance, enabling it to expand stably in the stomach and reducing the corrosion of gastric acid to the balloon 1, thereby prolonging the service life of the balloon 1; and the volume of the balloon 1 is the volume of gas or liquid that can be filled into the balloon 1, not exceeding 700 ml at most, preventing side effects (such as gastric perforation, rupture) caused by overfilling of the balloon 1 and reducing harm to the human body.

[0044] In a specific implementation manner of this embodiment, a sleeve 211 is provided at the connection end 21, a connection hole 212 is provided in the center of the sleeve 211, a joint end 31 matching the connection hole 212 is provided on the Luer connector 3, and the self-closing sealing piece 9 is arranged at the connection hole 212 for sealing the connection hole 212; the self-closing sealing piece 9 is prepared from elastic rubber or elastic silica gel, an opening groove 91 is provided in the center of the self-closing sealing piece 9, and the opening groove 91 can be one of a "one" shape, a "cross" shape or a "rice" shape, preferably a "cross" shape structure (as shown in the figure), the opening groove 91 is in a sealed state under normal conditions, and the opening groove 91 is opened after the joint end 31 of the Luer connector 3 is inserted, so that the connection conduit 2 and the filling conduit 4 are interconnected; among them, the self-closing sealing piece 9 at the connection hole 212 can be in a sealed state under normal conditions and the opening groove 91 is opened after the joint end 31 of the Luer connector 3 is inserted, so that even when no pipeline is connected to the connection end 21 of the connection conduit 2, sealing can be achieved through the self-closing sealing piece 9. At the same time, the self-closing sealing piece 9 prepared from elastic rubber or elastic silica gel has good elasticity and resilience effect. After the joint end 31 of the Luer connector 3 is inserted into the opening groove 91 of the self-closing sealing piece 9, the self-closing sealing piece 9 can be squeezed open to realize the connection and interconnection of the connection conduit 2 and the filling conduit 4, ensuring that liquid or gas can be sent into or out of the balloon 1 through the filling conduit 4 and the connection conduit 2 to realize the adjustment of the volume of the balloon 1. And when the filling conduit 4 is removed from the connection end 21 of the connection conduit 2, the self-closing sealing piece 9 can automatically rebound and close to realize the sealing of the connection conduit 2.

[0045] In a specific implementation manner of this embodiment, a connection hole matching the bottom of the sleeve 211 is provided at the top of the sealing cover 7, and a sealing gasket 71 is provided in the connection hole; among them, the sealing cover 7 can be fixed by screwing or snap-fitting at the sleeve 211, and the connection hole can be used to accommodate the end of the sleeve 211 to increase the connection tightness between the sealing cover 7 and the connection end 21; and the sealing gasket 71 can be prepared from rubber or silica gel materials, so that the sealing cover 7 can increase the sealing performance at the connection with the sleeve 211 through the sealing gasket 71 and further improve the sealing effect of the sealing cover 7.

[0046] In one specific embodiment of this example, the syringe has an injection capacity of 50-60 ml, and the syringe tip is also connected to a Luer connector 3 (not shown in the figure) for connecting to a three-way shut-off valve 5; wherein, after the syringe is connected to the three-way shut-off valve 5 through the Luer connector 3, the tightness of the connection between the syringe and the three-way shut-off valve 5 can be ensured, reducing leakage of injection liquid or gas.

[0047] In one specific embodiment of this invention, the self-closing sealing plug 6 includes a housing 61, a spring 62, and a plug body 63. The housing 61 is fitted onto the pre-bent end 22. The housing 61 has an internal guiding cavity, and its outer side wall has at least one through hole 611 communicating with the guiding cavity; preferably, there are two through holes 611. The plug body 63 is slidably disposed inside the guiding cavity. The spring 62 is fixed to the top of the plug body 63 and connected to the inner wall of the top of the guiding cavity, so that the plug body 63, under the action of the spring 62, blocks the flow in the guiding cavity. Between the flow cavity and the through hole 611; the bottom of the plug body 63 is provided with a first flow guide hole 631, and the outer side wall of the plug body 63 is provided with at least one second flow guide hole 632 corresponding to the position of the through hole 611. Preferably, there are two second flow guide holes 632, which are connected to the first flow guide hole 631. When the spring 62 is compressed or stretched, the through hole 611 can be connected to the flow guide cavity through the first flow guide hole 631 and the second flow guide hole 632 on the plug body 63; the bottom of the outer shell 61 is also provided with an assembly hole for connecting the pre-bent end 22 to ensure The self-closing sealing plug 6 can be snapped or threaded onto the pre-bent end 22; after the plug body 63 is movably set in the guide cavity by the spring 62, when the balloon 1 is inflated with air or liquid, the air pressure or hydraulic pressure will directly act on the plug body 63 and compress the spring 62, causing the plug body 63 to move upward in the guide cavity and connect the through hole 611 with the guide cavity, so as to ensure that the injected gas or liquid can be sent into the balloon 1 through the through hole 611, thereby adjusting the volume of the balloon 1; and when the gas or liquid inside the balloon 1 needs to be extracted, the air or liquid is extracted. The negative pressure generated by the liquid will pull the spring 62 to stretch and push the plug 63 down along the guide cavity. The through hole 611 can be connected to the guide cavity through the first guide hole 631 and the second guide hole 632 to ensure that the gas or liquid inside the balloon 1 can be extracted. When the balloon 1 does not need to be injected or discharged with gas or liquid, the plug 63 will block the communication gap between the through hole 611 and the guide cavity under the action of the spring 62 to ensure that the connecting tube 2 can also have a sufficient sealing effect at the pre-bent end 22, further reducing the leakage of gas or liquid.

[0048] In one specific embodiment of this example, the center of the promoter 8 is provided with a cavity for accommodating the balloon 1, and one end of the promoter 8 is a pointed tip for connecting to an endoscope.

[0049] The present invention also provides an adjustment method for an adjustable balloon system, applied to the adjustable balloon system described above, comprising the following steps:

[0050] S1. Perform preparations for the endoscopy examination according to hospital procedures and take conscious sedation measures on the patient;

[0051] S2. Perform an endoscopic examination on the patient to assess for any contraindications or other conditions. Contraindications include, but are not limited to, patients under 18 years of age, pregnant patients, patients with a history of gastrointestinal inflammation (including ulcers, any erosive gastritis, grade 3-4 esophagitis, Barrett's esophagus, or specific inflammations such as Crohn's disease or ulcerative colitis), severe coagulation disorders (upper gastrointestinal bleeding, such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia), congenital or acquired gastrointestinal abnormalities (such as atresia or stenosis), emotional / eating disorders, drug misuse, etc. Systemic lupus erythematosus, scleroderma or other diagnosed or symptomatic autoimmune connective tissue diseases, medical conditions (cardiopulmonary diseases), any other medical conditions that may increase the risk of endoscopy or weight loss, previous gastric, esophageal-gastric weight loss or duodenal surgery, clinically obvious esophageal hernia, esophageal diverticulum, stricture, annular or reticular esophageal stenosis, gastrointestinal motility disorders (severe esophageal motility disorders, gastric spasms or intractable constipation), need for known ulcer medications (such as aspirin, nonsteroidal anti-inflammatory drugs), silicone allergy, users who cannot or are not compatible with medically supervised diet and behavior modification programs, etc.

[0052] S3. Remove the endoscope and clean it thoroughly according to hospital procedures. Then remove the adjustable balloon system from the packaging, disassemble each component in turn, and place them one by one on the operating platform.

[0053] S4. Fix the promoter 8 to the distal end of the endoscope, and roll the uninflated balloon 1 and connecting catheter 2 into the promoter 8, so that the end of the balloon 1 protrudes 3 mm from the end of the promoter 8. The connecting catheter 2 is located at the proximal end hole of the promoter 8. Then connect the inflation catheter 4 to the connecting end 21 of the connecting catheter 2 through the Luer connector 3, ensuring that the Luer connector 3 is tightly inserted into the connecting end 21. Next, apply medical lubricating gel or other lubricant to the entire outside of the promoter 8. Insert the endoscope and the promoter 8 containing the balloon 1 and connecting catheter 2 as a whole into the patient's throat, and advance it into the esophagus and stomach according to the conventional insertion method of the endoscope.

[0054] S5. After the endoscope reaches the stomach, connect the other two ports of the three-way shut-off valve 5 on the filling catheter 4 to the syringe and the solution bag respectively, and then inject 500ml of gas or liquid into the balloon 1. If any resistance is encountered during the inflation or liquid filling process of the balloon 1, the endoscope needs to be repositioned until the gas or liquid flows easily and then stop. After that, pull the endoscope proximally to confirm whether the balloon 1 has been released from the promoter 8.

[0055] S6. Place the endoscope tip on one side of the connecting catheter 2 in the middle of the esophagus, then pull out the filling catheter 4 to separate the filling catheter 4 from the connecting catheter 2. Then fix the sealing cap 7 to the connecting end 21 of the connecting catheter 2 to seal it. After sealing, push the balloon 1 and the connecting catheter 2 with the sealing cap 7 into the stomach through the endoscope tip, remove the endoscope, and complete the intragastric implantation of the adjustable balloon system.

[0056] S7. After ensuring that the adjustable balloon system is fully implanted, check with an endoscope to confirm whether the balloon 1 and the connecting catheter 2 are leaking. If everything is normal, use the endoscope to capture the connecting end 21 of the connecting catheter 2 and pull the connecting end 21 to the tip of the endoscope to prevent the connecting end 21 from getting stuck at the connection. Pull the connecting end 21 up by moving the endoscope, then remove the sealing cap 7 (keep it), reinsert the filling catheter 4, and connect the filling catheter 4 to the connecting end 21 of the connecting catheter 2 through the Luer connector 3. Then release the filling catheter 4 and let it slowly slide into the larynx.

[0057] S8. Observe the position of balloon 1 in the stomach through the endoscope to confirm that balloon 1, connecting catheter 2 and filling catheter 4 are not twisted or folded. If twisting or folding occurs, use the tip of the endoscope to pull the filling catheter 4 to loosen the twist or fold. Then connect the other two ports of the three-way shut-off valve 5 on the filling catheter 4 to the syringe and solution bag respectively to replenish or release the gas or liquid injected into balloon 1 until the gas or liquid in balloon 1 reaches the appropriate volume. Then repeat step S6 to separate the filling catheter 4 from the connecting catheter 2 and connect the sealing cap 7 to the connecting catheter 2. Then remove the endoscope.

[0058] In one specific embodiment of this example, when the adjustable balloon system needs to be removed, the status of the balloon 1 and the connecting catheter 2 can be checked by endoscopy. Step S7 is used to replace the sealing cap 7 with the inflation catheter 4. Then, step S8 is used to empty the gas or liquid inside the balloon 1. Finally, the balloon 1 is grasped by grasping forceps or clamps so that the balloon 1 is pressed against the endoscope tip, and the balloon 1 is removed from the patient's esophagus by endoscopy.

[0059] It should be noted that the adjustable balloon system provided by this invention has a maximum service life of 12 months. It can be temporarily used for weight loss in morbidly obese patients (BMI 40 and above or BMI 35 and comorbid diseases) before bariatric surgery or other surgeries to reduce surgical sutures. It can also be temporarily used for weight loss in overweight or obese patients (BMI > 27).

[0060] In summary, the adjustable balloon system and adjustment method provided by this invention allow the balloon 1 to expand and occupy space in the stomach, thus creating a feeling of fullness and reducing food intake to achieve weight loss. The filling catheter 4, connected to the connecting catheter 2 via the Luer connector 3, allows the balloon 1 to adjust its volume after insertion into the stomach via syringes and solution bags connected to the other two ports of the three-way shut-off valve 5. This allows users to adjust the weight loss effect according to their needs, achieving quantitative correction of diet, ensuring precise weight loss control, meeting the different weight loss needs of different users, and improving applicability. The sealing cap 7 allows for... After disassembly, the infusion catheter 4 ensures that the gas or liquid injected into the balloon 1 will not leak from the connecting catheter 2, thus ensuring the stable use of the balloon 1. The self-closing sealing plug 6 and the self-closing sealing sheet 9 allow the connecting catheter 2 to maintain a certain degree of sealing even before the sealing cap 7 is used, reducing the possibility of gas or liquid leakage from the balloon 1 and further improving the stability of the balloon 1 during use. The facilitator 8 allows the balloon 1 to wrap around the connecting catheter 2 in a compressed state, so that after the facilitator 8 is connected to the endoscope, it can move with the endoscope to place the balloon 1, which is conducive to the insertion of the balloon 1 into the stomach, reduces the implantation risk, and reduces the pain of the patient during implantation.

[0061] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. The illustrative expressions of the above terms in this specification should not be construed as necessarily referring to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. In addition, those skilled in the art can combine and integrate the different embodiments or examples described in this specification.

[0062] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of the present invention.

Claims

1. An adjustable balloon system, comprising a balloon (1), a connecting catheter (2), and an inflation catheter (4); characterized in that: It also includes a sealing cap (7) and an accelerator (8); the connecting catheter (2) is a flexible catheter, with a connecting end (21) and a pre-bent end (22) at each end of the connecting catheter (2), a self-closing sealing piece (9) at the connecting end (21), the end of the connecting catheter (2) near the pre-bent end (22) being connected to the balloon (1), the pre-bent end (22) being located in the inner cavity of the balloon (1), and a self-closing sealing plug (6) being fitted at one end of the pre-bent end (22); the filling catheter (4) and the sealing cap (7) can be detached from the connecting end (21) of the connecting catheter (2); the filling catheter ( 4) is connected to Luer connector (3) and three-way shut-off valve (5) at both ends respectively. The filling catheter (4) is connected to the connecting end (21) of the connecting catheter (2) through Luer connector (3). The other two ports of the three-way shut-off valve (5) are connected to the syringe and the solution bag respectively. The sealing cap (7) is used to seal the connecting end (21) port of the connecting catheter (2) after the filling catheter (4) is disassembled. The promoter (8) is fitted on the outside of the balloon (1) and the connecting catheter (2) in the compressed state of the balloon (1), so that the balloon (1) and the connecting catheter (2) can be fixed to the end of the endoscope and sent into the user's stomach through the promoter (8). The self-closing sealing plug (6) includes a shell (61), a spring (62), and a plug body (63); the shell (61) is fitted onto the pre-bent end (22), and the shell (61) has a flow guiding cavity inside, and at least one through hole (611) communicating with the flow guiding cavity is provided on the outer side wall of the shell (61); the plug body (63) is slidably disposed inside the flow guiding cavity, and the spring (62) is fixed to the top of the plug body (63) and connected to the inner wall of the top of the flow guiding cavity, so that the plug body (63) is in contact with the spring (62). Under the action of the flow, it is blocked between the flow guide cavity and the through hole (611); the bottom of the plug body (63) is provided with a flow guide hole one (631), and the outer side wall of the plug body (63) is provided with at least one flow guide hole two (632) corresponding to the position of the through hole (611). The flow guide hole two (632) is connected to the flow guide hole one (631). When the spring (62) is compressed or stretched, the through hole (611) can be connected to the flow guide cavity through the flow guide hole one (631) and the flow guide hole two (632) on the plug body (63).

2. The adjustable balloon system as described in claim 1, characterized in that: The balloon (1) is made of acid-resistant silicone elastomer and has a volume of 400-700 ml.

3. The adjustable balloon system as described in claim 1, characterized in that: The connecting end (21) is provided with a sleeve (211), and the sleeve (211) has a connecting hole (212) in the center. The Luer connector (3) is provided with a connector end (31) that matches the connecting hole (212). The self-closing sealing plate (9) is provided at the connecting hole (212) to seal the connecting hole (212). The self-closing sealing plate (9) is made of elastic rubber or elastic silicone. The self-closing sealing plate (9) has an opening groove (91) in the center. The opening groove (91) can be one of the following: "I", "+" or "M". The opening groove (91) is in a sealed state under normal conditions. After the connector end (31) of the Luer connector (3) is inserted, the opening groove (91) is opened to make the connecting conduit (2) and the filling conduit (4) communicate with each other.

4. An adjustable balloon system as described in claim 3, characterized in that: The top of the sealing cap (7) is provided with a connection hole that matches the bottom of the sleeve (211), and a sealing gasket (71) is provided in the connection hole.

5. An adjustable balloon system as described in claim 1, characterized in that: The syringe has an injection capacity of 50-60 ml, and the syringe tip is also connected to a Luer connector (3) for connecting a three-way shut-off valve (5).

6. An adjustable balloon system as described in claim 1, characterized in that: The promoter (8) has a cavity in the center for accommodating the balloon (1), and one end of the promoter (8) is a tip for connecting to an endoscope.

7. An adjustable balloon system as described in claim 6, characterized in that, The usage steps include the following: S1. Perform preparations for the endoscopy examination according to hospital procedures and take conscious sedation measures on the patient; S2. Perform an endoscopic examination on the patient to assess whether there are any contraindications or other medical conditions; S3. Remove the endoscope and clean it thoroughly according to hospital procedures. Then remove the adjustable balloon system from the packaging, disassemble each component in turn, and place them one by one on the operating platform. S4. Fix the facilitator (8) at the distal end of the endoscope, and roll the uninflated balloon (1) and connecting catheter (2) into the facilitator (8), so that the end of the balloon (1) protrudes 3 mm from the end of the facilitator (8), and the connecting catheter (2) is located at the proximal end hole of the facilitator (8). Then connect the inflation catheter (4) to the connecting end (21) of the connecting catheter (2) through the Luer connector (3), ensuring that the Luer connector (3) is tightly inserted into the connecting end (21). Next, apply medical lubricating gel or other lubricant to the entire outside of the facilitator (8), and insert the endoscope and the facilitator (8) containing the balloon (1) and connecting catheter (2) as a whole into the patient's throat, and advance it into the esophagus and stomach according to the conventional insertion method of the endoscope. S5. After the endoscope reaches the stomach, connect the other two ports of the three-way shut-off valve (5) on the filling catheter (4) to the syringe and the solution bag respectively, and then inject 500ml of gas or liquid into the balloon (1). Then pull the endoscope proximally to confirm whether the balloon (1) is released from the promoter (8). S6. Place the endoscope tip on one side of the connecting catheter (2) in the middle of the esophagus, then pull out the filling catheter (4) to separate the filling catheter (4) from the connecting catheter (2), and then fix the sealing cap (7) at the connecting end (21) of the connecting catheter (2) to seal it. After sealing, push the balloon (1) and the connecting catheter (2) with the sealing cap (7) into the stomach through the endoscope tip, remove the endoscope, and complete the intragastric implantation of the adjustable balloon system. S7. After ensuring that the adjustable balloon system is fully implanted, check with an endoscope to confirm whether the balloon (1) and the connecting catheter (2) are leaking. If everything is normal, use an endoscope to capture the connecting end (21) of the connecting catheter (2) and pull the connecting end (21) to the tip of the endoscope. Move the endoscope to pull the connecting end (21) up, then remove the sealing cap (7), reinsert the filling catheter (4), and connect the filling catheter (4) to the connecting end (21) of the connecting catheter (2) through the Luer connector (3). Then release the filling catheter (4) and let it slowly slide into the larynx. S8. Observe the position of the balloon (1) in the stomach through the endoscope to confirm that the balloon (1), connecting catheter (2) and filling catheter (4) are not twisted or folded. If twisting or folding occurs, use the tip of the endoscope to pull the filling catheter (4) to loosen the twist or fold. Then connect the other two ports of the three-way shut-off valve (5) on the filling catheter (4) to the syringe and solution bag respectively to replenish or release the gas or liquid injected into the balloon (1) until the gas or liquid in the balloon (1) reaches the appropriate volume. Then repeat step S6 to separate the filling catheter (4) from the connecting catheter (2) and connect the sealing cap (7) to the connecting catheter (2). Then remove the endoscope.

8. An adjustable balloon system as described in claim 7, characterized in that: In step S5, if the balloon (1) encounters any resistance during inflation or inflation, the endoscope needs to be repositioned until the gas or liquid can flow easily.

9. An adjustable balloon system as described in claim 7, characterized in that: When the adjustable balloon system needs to be removed, the status of the balloon (1) and connecting catheter (2) can be checked by endoscopy. In step S7, the sealing cap (7) is replaced with the filling catheter (4). Then, in step S8, the gas or liquid inside the balloon (1) is emptied. Finally, the balloon (1) is grasped by grasping forceps or clamps so that the balloon (1) is pressed against the endoscope tip. The balloon (1) is then removed from the patient's esophagus by endoscopy.

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