Intragastric weight reduction method based on volume-adjustable balloon

Abstract

The invention relates to the technical field of medical treatment, in particular to an intragastric weight loss method based on a volume-adjustable balloon, which comprises the following steps: detecting indexes such as body weight index and stomach volume of a target patient before an operation, and screening adapters; implanting a weight reduction balloon through a gastroscope, filling according to a preset initial volume, and monitoring the filling pressure in real time; the weight change, diet tolerance and the like of the patient are dynamically monitored after the operation, and the balloon volume is adjusted based on data; when the body weight is reduced and the diet tolerance reaches the standard, a degradation medium is injected to realize step-by-step volume reduction; and after the balloon is lowered to the lowest adaptive value and the body weight reaches the standard and is stable, taking out the balloon through a gastroscope and establishing a long-term follow-up mechanism. According to the method, personalized adaptation is achieved through multi-parameter threshold regulation and control, the volume is dynamically adjustable, volume reduction is accurate and controllable, minimally invasive operation is achieved in the whole process, safety is high, the tolerance of a patient and the stability of the weight reduction effect are effectively improved, and the clinical personalized weight reduction requirement is met.

Description

TECHNICAL FIELD

[0001] The present application relates to the medical technical field, and in particular, to a gastric weight loss method based on an adjustable volume balloon. BACKGROUND

[0002] With the rising incidence of obesity year by year, weight loss treatment has become a clinical focus. The current mainstream weight loss methods include surgical gastric resection surgery, diet and exercise intervention, and traditional gastric balloon implantation, etc., but all have significant defects: surgical trauma is large, postoperative recovery period is long, and the physical condition of the patient is strict; diet and exercise intervention rely on strong patient self-discipline, most people are difficult to adhere to for a long time, and the weight loss effect is easy to rebound; the traditional gastric balloon is mostly designed with fixed volume, which cannot dynamically adjust the volume according to the patient's weight change and diet tolerance, which is easy to cause gastrointestinal discomfort, and lacks a precise step-by-step volume reduction mechanism, making it difficult to adapt to the patient's physiological adaptation period, and some products have problems such as insufficient sealing reliability, inconvenience to remove, etc. Therefore, a minimally invasive, volume-dynamically-adjustable, highly adaptable and safe gastric weight loss method is urgently needed to solve the problems of large trauma, poor controllability and low patient tolerance in the prior art, and to meet the actual needs of clinical individualized weight loss treatment. SUMMARY

[0003] In view of this, the present application proposes a gastric weight loss method based on an adjustable volume balloon to solve at least one of the problems in the above background art.

[0004] The present application provides a gastric weight loss method based on an adjustable volume balloon, comprising the following steps: Detect the body mass index, gastric volume, and gastrointestinal function indicators of the target patient, and select the target patient based on the detection results; prepare a sterile adjustable volume weight loss balloon and matching liquid injection consumables, implant the folded weight loss balloon into the designated position of the patient's stomach cavity through a gastroscope; inject sterile normal saline through the balloon liquid injection channel, fill the balloon to the preset initial volume, and monitor the filling pressure in real time during the injection process; Monitor the target patient's weight change rate, diet tolerance, and gastrointestinal reaction; regularly confirm the balloon position stability through imaging examination, detect the gastric mucosa state, and dynamically adjust the initial volume of the balloon based on the monitoring data; When the target patient's weight loss rate reaches the preset range and the diet tolerance meets the preset standard, inject a preset concentration of degradation medium through the balloon special channel, control the injection amount and action time; monitor the balloon sealing, intragastric pressure and patient tolerance again after volume reduction, and determine whether to enter the next volume reduction cycle based on the volume reduction effect; When the balloon volume is reduced to the minimum fitting value, and the target patient weight reaches the target range and is stable for a preset length of time, the weight loss balloon is removed through a gastroscope, a long-term follow-up mechanism is established, body weight, metabolic indicators and dietary behavior are regularly monitored, and the risk of weight loss rebound is evaluated based on the follow-up data, and the dietary and exercise intervention program is dynamically adjusted.

[0005] In some embodiments, the target patient's body mass index, gastric volume, and gastrointestinal function indicators are detected, including: The preoperative detection indicators need to meet the condition that the BMI is greater than or equal to a preset lower threshold; The gastric volume is within a preset interval threshold, the liver and kidney function indicators are within a normal reference value threshold range, and the coagulation function indicators meet a preset standard threshold.

[0006] In some embodiments, the initial volume of the balloon is set according to a preset proportion threshold of the target patient's gastric volume, the inflation pressure is maintained at a preset pressure threshold interval, and the liquid injection is automatically stopped when the pressure exceeds a preset upper threshold; The sealing test is detected by pressure maintenance method, and when the pressure maintenance time reaches a preset length threshold and there is no pressure drop, it is determined that the sealing is qualified.

[0007] In some embodiments, when the target patient's weekly weight loss rate reaches a preset interval threshold, and the dietary intake is stable within a preset proportion threshold range for a continuous preset number of weeks, and there is no persistent gastrointestinal discomfort, the volume reduction is started.

[0008] In some embodiments, during the volume reduction, the pH value and concentration of the degradation medium are within a preset interval threshold, and the single injection amount is calculated according to a preset multiple threshold of the target volume reduction value; The degradation medium action time is controlled within a preset length threshold, the volume reduction effect is determined by monitoring the pressure change in the balloon, and the volume reduction is determined to be up to standard when the pressure drops to a preset proportion threshold.

[0009] In some embodiments, the repeated use of the balloon liquid injection needs to meet: The number of connections is greater than or equal to a preset number threshold, the sealing test passes a preset percentage threshold after each connection, the elastic recovery rate of the channel self-sealing structure is greater than or equal to a preset proportion threshold, there is no liquid leakage or the leakage amount is less than or equal to a preset trace threshold.

[0010] In some embodiments, the dynamic adjustment of the balloon initial volume based on the monitoring data is advanced according to a preset stage, and the single intake amount and the number of meals per day in each stage meet the corresponding preset threshold.

[0011] In some embodiments, the balloon is gradually reduced in volume within a preset time length threshold range, each time the volume is reduced by a preset proportion threshold of the current volume of the balloon, the cumulative number of times of volume reduction does not exceed a preset number threshold, and the final minimum volume of the balloon is not less than a preset lower threshold; when the body weight rebounds by more than a preset proportion threshold after volume reduction, the volume reduction amplitude of the next time is adjusted.

[0012] In some embodiments, the balloon volume is reduced to a preset interval threshold, the target patient BMI is reduced to below a preset upper threshold or the weight loss amplitude is greater than or equal to a preset proportion threshold, and the weight state is stable for greater than or equal to a preset time length threshold, the gastric mucosa is normal and the gastrointestinal function is restored to more than a preset proportion threshold, and the balloon is removed.

[0013] In some embodiments, long-term follow-up is performed at a preset time node to monitor the body weight and diet state.

[0014] Compared with the prior art, the beneficial effects of the present application are that: the patient is screened by multiple index thresholds before the operation, the initial volume of the balloon is set in combination with the preset proportion of the stomach volume, and the volume can be dynamically adjusted based on the body weight change and diet tolerance, so as to accurately match the physiological state of different patients and greatly reduce the risk of gastrointestinal discomfort. The preset standards such as weight loss rate and diet stability are used as the volume reduction trigger condition, and the gradual volume reduction is realized by controlling the degradation medium parameters, which adapts to the physiological adaptation period of the patient, avoids weight loss rebound, and improves treatment compliance. The balloon implantation and removal are both minimally invasive operations through a gastroscope, without the need for surgical operation, and the repeated docking of the liquid injection channel is reliable in sealing and has very low risk of leakage. At the same time, the gastric mucosa state is monitored regularly to effectively protect the health of the gastrointestinal tract. The balloon liquid injection and volume reduction process is standardized, which supports multiple repeated docking and use, reduces the difficulty of clinical operation; the long-term follow-up mechanism can evaluate the rebound risk in real time, dynamically adjust the intervention scheme, and ensure the long-term stability of the weight loss effect. In summary, the present application solves the pain points of the existing weight loss methods, such as large trauma, poor adaptability and unsustainable effect, and takes into account minimally invasive, controllability and safety, and meets the clinical individualized weight loss needs.

[0015] The foregoing general description and the following detailed description are merely exemplary and explanatory, rather than limiting the present disclosure.

[0016] Other features and aspects of the present disclosure will become more apparent from the following detailed description of exemplary embodiments with reference to the attached drawings. BRIEF DESCRIPTION OF DRAWINGS

[0017] In order to more clearly illustrate the specific embodiments of the present application or the technical solutions in the prior art, the following will briefly introduce the drawings needed to be used in the specific embodiments or the prior art description. Obviously, the drawings in the following description are some embodiments of the present application, and those skilled in the art can also obtain other drawings according to these drawings without creating any inventive labor.

[0018] Figure 1 A flow chart of a gastric weight loss method based on an adjustable volume balloon is provided. DETAILED DESCRIPTION

[0019] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by a person of ordinary skill in the art without creative work fall within the scope of protection of the present application.

[0020] In the description of the present application, it should be understood that the terms "center", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer" and the like indicate the orientation or positional relationship shown in the drawings based on the orientation or positional relationship shown in the drawings, and are only for the purpose of facilitating the description of the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application.

[0021] The terms "first", "second" are only for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the technical features indicated. Therefore, the features defined with "first", "second" can explicitly or implicitly include one or more of the features. In the description of the present application, unless otherwise specified, the meaning of "a plurality of" is two or more.

[0022] In the description of the present application, it should be noted that unless otherwise specified and limited, the terms "mounting", "connection", "connection" should be understood broadly, for example, it can be fixed connection, or detachable connection, or integral connection; it can be mechanical connection, or electrical connection; it can be directly connected, or indirectly connected through an intermediate medium, or the communication between the two elements inside. For a person of ordinary skill in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0023] Referring to Figure 1 As shown, according to the gastric weight loss method based on the adjustable volume balloon, the method comprises the following steps: S100, detecting the body mass index, stomach capacity, and gastrointestinal function index of a target patient, and selecting a suitable patient based on the detection results; preparing a sterile adjustable volume weight loss balloon and matching liquid injection consumables, implanting the folded weight loss balloon into a designated position in the stomach cavity of the patient through a gastroscope; injecting sterile normal saline through the balloon liquid injection channel to inflate the balloon to a preset initial volume, and monitoring the inflation pressure in real time during the injection process; S200, monitoring the weight change rate, diet tolerance, and gastrointestinal reaction of the target patient; regularly checking the balloon position stability through imaging examination, detecting the stomach mucosa state, and dynamically adjusting the initial volume of the balloon based on the monitoring data; S300, when the weight loss rate of the target patient reaches a preset range and the diet tolerance meets a preset standard, injecting a degradation medium with a preset concentration through a balloon special channel, controlling the injection amount and action time; after volume reduction, the balloon sealing property, intragastric pressure, and patient tolerance are monitored again, and whether to enter the next volume reduction cycle is determined based on the volume reduction effect; S400, when the balloon volume is reduced to the minimum adaptive value and the weight of the target patient reaches the target range and is stable for a preset period of time, the weight loss balloon is removed through a gastroscope, a long-term follow-up mechanism is established, the weight, metabolic indicators, and diet behavior are regularly monitored, the weight loss rebound risk is evaluated based on the follow-up data, and the diet and exercise intervention scheme is dynamically adjusted.

[0024] It should be understood that the necessary features include a preoperative multi-index detection screening mechanism, a minimally invasive implantation and liquid injection technology, a postoperative dynamic monitoring and volume adjustment logic, a volume reduction triggering and precise control based on preset standards, a minimally invasive removal by gastroscope, and a long-term follow-up intervention system. Among them, the preoperative detection completes the index collection through the clinical routine physical examination equipment, and the suitable patients are selected to exclude the surgical risk; the balloon implantation is achieved by minimally invasive delivery through the working channel of the gastroscope, the liquid injection uses sterile normal saline as the filling medium, and the inflation safety is ensured through pressure monitoring; the postoperative monitoring collects data relying on the body weight scale, imaging equipment (ultrasound / gastroscope), and patient diet feedback, and the dynamic volume adjustment is achieved by liquid injection / liquid extraction or degradation medium injection, and the physiological state of the adaptive patient; the volume reduction is achieved by the chemical reaction between the degradation medium and the balloon material to destroy the outer structure and reduce the volume, the removal process reuses the minimally invasive operation of the gastroscope, and the follow-up collects data through regular reexamination and adjusts the diet and exercise scheme. Illustrative example: select BMI≥28 kg / m 2, a patient with a stomach volume of 1000ml, normal liver and kidney function, and coagulation function before surgery, implantation of a balloon with a folded diameter of ≤12mm, injection of 250ml of normal saline (filling pressure 0.08MPa); postoperative monitoring of the patient showed a weekly weight loss of 0.8kg, good dietary tolerance, and dynamic volume stability; when the continuous 2-week weight loss rate was up to standard, 7ml of pH 7.5 alkaline degradation solution was injected, and the effect lasted for 60 minutes to achieve a 50ml volume reduction; the volume reduction was repeated 3 times with an interval of 1 month to reach a volume of 80ml; the patient's BMI decreased to 23kg / m 2 After 4 weeks of stabilization, the balloon was removed through gastroscopy, and the patient was followed up for 12 months without weight rebound. Technical effect: The technology realizes minimally invasive and personalized weight loss treatment, with no surgical trauma throughout the process, dynamic volume adjustment to reduce gastrointestinal discomfort, step-by-step volume reduction to avoid weight loss rebound, long-term follow-up to ensure stable results, and solving the pain points of poor adaptability and unsustainable results of existing methods.

[0025] In some embodiments, the target patient is subjected to body mass index, stomach volume, and gastrointestinal function index detection, which includes: The preoperative detection index needs to meet the condition that the BMI is greater than or equal to a preset lower threshold; The stomach volume is within a preset interval threshold, the liver and kidney function index is within a normal reference value threshold range, and the coagulation function index meets a preset standard threshold.

[0026] It should be understood that the necessary features are a threshold screening mechanism for the four key indicators before surgery, in which the BMI threshold is used to define the scope of obese patients to ensure the treatment targeting; the stomach volume threshold provides a basis for the initial volume setting of the balloon to avoid mismatch between the balloon and the stomach cavity; the liver and kidney function index threshold ensures that the patient can tolerate the physiological load after surgery and balloon implantation, and the coagulation function index threshold reduces the risk of bleeding during and after surgery; each index is detected by a clinical routine detection device (BMI scale, stomach volume measuring instrument, biochemical analyzer, and coagulation function detector), and the operating principle is to set a safety threshold based on medical clinical standards and exclude patients who are not suitable. Illustrative example: the preset lower threshold of BMI is 28kg / m 2 , the stomach volume preset interval threshold is 800-1500ml, the normal reference value threshold of liver and kidney function index is the clinical standard range (such as glutamic-pyruvic transaminase 5-40U / L, blood creatinine 53-106μmol / L), and the coagulation function preset standard threshold is prothrombin time 11-13.7 seconds; a patient with a BMI of 29kg / m 2 , a stomach volume of 1100ml, liver and kidney function indexes within the normal range, a prothrombin time of 12.5 seconds, and no contraindications is determined to meet the implantation conditions. Technical effect: Through precise index threshold screening, it is ensured that the implanted patient has good treatment adaptability, the risk of surgery and postoperative complications is reduced from the source, and the safety and targeting of weight loss treatment are improved.

[0027] In some embodiments, the initial volume of the balloon is set according to a preset proportion threshold of the target patient's stomach volume, the inflation pressure is maintained at a preset pressure threshold interval, and the injection is automatically stopped when the pressure exceeds a preset upper threshold. The sealing test is detected by pressure maintenance method, and when the pressure maintenance time reaches a preset time threshold and there is no pressure drop, it is determined that the sealing is qualified.

[0028] It should be understood that the necessary features are the initial volume proportion setting mechanism, the inflation pressure control mechanism and the sealing test mechanism; the principle of setting the initial volume according to the proportion of the stomach volume is to adapt to the size of the stomach cavity of different patients and avoid local compression or insufficient volume; the inflation pressure control is monitored by a pressure sensor in real time, and the operation mode of automatic stop injection when the pressure exceeds the upper limit is to trigger the sensor to power off or close the valve of the injection device, preventing the balloon from being overfilled and broken; the sealing test uses the pressure maintenance method, which verifies the sealing of the balloon and the injection channel by maintaining a fixed pressure for a period of time, avoiding liquid leakage. Exemplary explanation: the preset proportion threshold of the patient's stomach volume is 35%, the preset interval threshold of the inflation pressure is 0.06-0.1 MPa, the preset upper threshold of the pressure is 0.15 MPa, and the preset time threshold of the sealing test is 30 seconds; the patient's stomach volume is 1000ml, the initial volume is calculated as 350ml, the pressure sensor monitors in real time during the injection process, and when the pressure reaches 0.1MPa, the injection is maintained to 350ml, then 5ml of normal saline is injected to make the pressure rise to 0.3MPa, and maintained for 30 seconds without pressure drop, it is determined that the sealing is qualified. Technical effect: the initial volume proportion setting ensures the accurate adaptation of the balloon to the stomach cavity, the inflation pressure control avoids the risk of balloon rupture, the sealing test ensures no leakage after injection, and the three work together to improve the stability and safety of the balloon after implantation, laying a foundation for subsequent weight loss treatment.

[0029] In some embodiments, when the target patient's weekly weight loss rate reaches a preset interval threshold, and the dietary intake has been stable within a preset proportion threshold range for a continuous preset number of weeks, and there is no persistent gastrointestinal discomfort, the volume reduction is started.

[0030] It should be understood that the necessary features are three joint indicators of volume reduction initiation, in which the weight loss rate threshold reflects the weight loss effect, the stable diet intake threshold reflects the patient's adaptation state, and the non-persistent gastrointestinal discomfort threshold ensures treatment safety; the weight loss rate is calculated by weighing at a fixed time per week, the diet intake is calculated by combining the patient's diet diary with the actual intake record, and the gastrointestinal discomfort is determined by patient feedback and clinical symptom observation; the operating principle is to set a trigger threshold based on the patient's physiological adaptation state to ensure that the volume reduction opportunity matches the patient's physical state. Illustrative example: the preset weekly weight loss rate threshold is 0.5-1.2 kg, the continuous preset number of weeks is 2 weeks, and the diet intake preset proportion threshold is 60%-80% of the current balloon volume; a patient's balloon current volume is 300 ml, the weight loss is 0.9 kg per week for 2 consecutive weeks, the diet intake is stable at 210-240 ml (70%-80% of the balloon volume), and there is no persistent gastrointestinal discomfort such as nausea and vomiting, and it is determined that the volume reduction initiation condition is met. Technical effect: through multi-dimensional threshold joint determination, the volume reduction opportunity is accurately grasped, premature volume reduction is avoided, which leads to poor weight loss effect or late volume reduction, which causes gastrointestinal discomfort, improves patient treatment tolerance, and ensures the stability of the weight loss process.

[0031] In some embodiments, when the volume is reduced, the pH and concentration of the degradation medium are within the preset interval threshold, and the single injection amount is calculated according to the preset multiple threshold of the target volume reduction value. The degradation medium action time is controlled within the preset time threshold, the volume reduction effect is determined by monitoring the change of the balloon internal pressure, and the pressure is reduced to the preset proportion threshold.

[0032] It should be understood that the necessary features are degradation medium parameter regulation mechanism, injection amount calculation mechanism, action time control mechanism and volume reduction standard judgment mechanism; the degradation medium pH value and concentration threshold are designed based on the balloon outer layer membrane material (such as PLGA50:50), which ensures that only the outer layer membrane is degraded without damaging the inner layer membrane; the principle of setting the injection amount according to the target volume reduction value multiple is to ensure sufficient action of the degradation medium and avoid incomplete volume reduction; the action time control is realized through a timing device to prevent damage to the inner layer membrane due to long-term action of the medium; the volume reduction standard judgment is based on the positive correlation between pressure and volume, and the pressure sensor is used to monitor the pressure change to reflect the volume decrease. Illustrative description: the preset pH value interval threshold of the degradation medium is 7.2-7.8, the concentration interval threshold is 4%-6%, the preset multiple threshold of the target volume reduction value is 1.5 times, the preset time threshold of the action time is 30-90 minutes, and the preset proportion threshold of the pressure drop is 40%; the target volume reduction value is 50ml, the calculated single injection amount is 75ml, the pH value of the alkaline degradation liquid is 7.5, the concentration is 5%, the injection is maintained for 60 minutes, the pressure in the balloon is monitored from 0.08MPa to 0.032MPa (decreased by 40%), and it is determined that the volume reduction is up to standard. Technical effect: precise and controllable volume reduction process, degradation medium parameters adapted to balloon material, reasonable matching of injection amount and action time, pressure monitoring to ensure that the volume reduction effect meets the standard, which avoids insufficient volume reduction affecting the treatment progress and prevents excessive degradation damage to the balloon, improving the safety and accuracy of volume reduction operation.

[0033] In some embodiments, the balloon liquid injection repeated use needs to meet: The number of docking is greater than or equal to the preset number threshold, the sealing test qualified rate after each docking reaches the preset percentage threshold, the elastic recovery rate of the channel self-sealing structure is greater than or equal to the preset proportion threshold, there is no liquid leakage or the leakage amount is less than or equal to the preset trace threshold.

[0034] It should be understood that the necessary features are four performance threshold standards for the reuse of the liquid injection channel, wherein the threshold value of the number of docking times guarantees the durability of the channel, the threshold value of the sealing test pass rate guarantees the sealing performance, the threshold value of the elastic recovery rate guarantees the sealing effect of the self-sealing structure after repeated use, and the threshold value of the leakage amount directly controls the leakage risk; the channel adopts double-sealing joints (the male joint is provided with a double-layer silica gel self-sealing pad, and the female joint is provided with two sealing grooves), and after each docking during reuse, a pressure maintenance method is performed for sealing test, the elastic recovery rate is measured by a mechanical detection device, and the leakage amount is measured by a precision measuring cup, and the operation principle is to ensure that the channel can still maintain sealing reliability after repeated use through multi-dimensional performance threshold constraints. Illustrative description: the preset threshold value of the number of docking times is 20 times, the preset percentage threshold value of the sealing test pass rate is 100%, the preset proportion threshold value of the elastic recovery rate is 95%, and the preset trace threshold value of the leakage amount is 0.1 ml / min; a certain liquid injection channel is repeatedly docked for 20 times, the sealing test is qualified after each docking, the elastic recovery rate of the self-sealing structure is 96%, and the leakage amount during the liquid injection process is 0.03 ml / min, and it is determined that the reuse requirement is met. Technical effect: the liquid injection channel can be reused to reduce the cost of consumables, the multi-dimensional performance threshold guarantees the sealing reliability after repeated use, avoids the leakage from causing gastric infection or capacity loss, and improves the convenience and safety of clinical operation.

[0035] In some embodiments, the balloon initial volume is dynamically adjusted based on the monitoring data and pushed according to preset stages, and the single intake amount and the number of meals per day in each stage meet the corresponding preset threshold value.

[0036] It should be understood that the necessary features are a stepwise diet transition mechanism and a volume dynamic adjustment linkage mechanism; the diet transition is pushed according to preset stages of “fasting → liquid → semi-liquid → soft food”, the intake amount and the number of meals threshold value in each stage is set based on the balloon volume and the gastrointestinal adaptation rule, the operation principle is to first adapt the balloon occupied volume through diet adjustment, and when the diet adjustment cannot meet the tolerance requirement, the balloon volume is dynamically adjusted to avoid discomfort caused by improper volume; the volume adjustment is realized by liquid injection channel liquid extraction or small amount of liquid supplement, and is synchronized with the diet transition. Illustrative description: the preset diet transition stages are postoperative fasting for 24 hours, liquid diet for 2-7 days (single intake amount of 50-100 ml, 7 times a day), semi-liquid diet for 8-14 days (single intake amount of 100-150 ml, 5 times a day), and soft food after 15 days (single intake amount ≤ 1 / 3 of the balloon volume); a patient is in the liquid diet stage 3 days after the operation, and still feels that the satiety is not enough with a single intake of 80 ml, which is first increased to 92 ml by 15% proportion, and after the adjustment, it still cannot meet the requirement, the balloon volume is adjusted from 250 ml to 220 ml through the liquid injection channel liquid extraction, and the patient's tolerance is significantly improved. Technical effect: the diet transition and volume adjustment are cooperatively adapted, which helps the patient to gradually adapt to the state of eating less, and dynamically adjusts the volume to meet the tolerance requirement.

[0037] In some embodiments, the balloon volume is reduced by a preset proportion threshold of the current balloon volume at a preset time interval, and the cumulative number of volume reductions does not exceed a preset number threshold, and the final balloon minimum volume is not less than a preset lower threshold; when the body weight rebounds by more than a preset proportion threshold after volume reduction, the next volume reduction amplitude is adjusted.

[0038] It should be understood that the necessary features include volume reduction interval threshold control, volume reduction amplitude proportion threshold control, cumulative volume reduction number threshold limit, minimum volume threshold bottoming, and amplitude adjustment mechanism after weight rebound; the setting principle of the volume reduction interval threshold is to reserve a physiological adaptation period for the patient to avoid discomfort caused by sudden volume change; the volume reduction amplitude is set in proportion to the current volume, which can adapt to the balloon volume at different stages and ensure smooth volume reduction; the cumulative number and minimum volume threshold limit are to prevent excessive volume reduction from causing weight loss failure or unstable balloon structure; weight rebound monitoring is achieved by regular weighing after volume reduction, and the amplitude adjustment dynamically reduces the volume reduction amplitude according to the rebound proportion, and the operation mode is a closed-loop control of "volume reduction-monitoring-evaluation-adjustment". Exemplary explanation: the preset volume reduction interval time threshold is 1-2 months, the preset proportion threshold of the volume reduction amplitude is 25%, the preset threshold of the cumulative number of volume reductions is 4 times, the preset lower threshold of the balloon minimum volume is 50ml, and the preset proportion threshold of the weight rebound is 3%; the initial balloon volume of the patient is 320ml, the volume is reduced to 240ml after the first volume reduction, the second volume reduction is performed after an interval of 1.5 months, and it is intended to reduce to 180ml by 25% amplitude, it is found that the weight rebounds by 4% (exceeding the preset threshold) after 1 week of volume reduction, so the second volume reduction amplitude is adjusted to 15%, and finally reduced to 204ml; the subsequent 4 volume reductions are completed according to the adjusted logic, and the final volume is maintained at 68ml (not less than 50ml). Technical effect: By multi-dimensional threshold quantitative control of volume reduction process, gastrointestinal discomfort caused by sudden volume change is avoided, cumulative number and minimum volume limit ensure the continuity of weight loss effect, and the amplitude adjustment mechanism after weight rebound can timely correct the volume reduction pace to ensure smooth and sustainable weight loss process.

[0039] In some embodiments, the balloon volume is reduced to a preset interval threshold, the target patient BMI is reduced to below a preset upper threshold or the weight loss amplitude is greater than or equal to a preset proportion threshold, and the weight state is stable for greater than or equal to a preset time threshold, the gastric mucosa is normal and the gastrointestinal function is restored to more than a preset proportion threshold, and the balloon is removed.

[0040] It should be understood that the necessary features are the four core indicators for balloon removal, among which the balloon volume threshold is to ensure that the balloon can be folded and contracted for removal through the gastroscope channel; the BMI and weight loss amplitude threshold is the core basis for achieving the weight loss treatment goal; the body weight stabilization duration threshold is to exclude short-term weight fluctuations and ensure the solidification of weight loss effect; the gastric mucosa and gastrointestinal function threshold is the key to ensure the safety of the removal process and avoid postoperative complications; each indicator is determined through imaging examination (ultrasound / gastroscope), body weight monitoring, and gastrointestinal function evaluation, and the operation principle is multi-condition joint verification, which not only ensures that the treatment effect meets the standard, but also ensures that the patient's physical state is suitable for removal operation. Exemplary explanation: the preset balloon volume removal interval threshold is 50-100 ml, the preset upper limit threshold of BMI is 24 kg / m 2 , the preset proportion threshold of weight loss amplitude is 15%, the preset duration threshold of weight stabilization is 4 weeks, and the preset proportion threshold of gastrointestinal function recovery is 80%; after multiple volume reductions, the balloon volume of the patient is reduced to 75 ml, the BMI is reduced from the initial 29 kg / m 2 to 23.5 kg / m 2 (lower than the preset upper limit), the weight loss amplitude reaches 18.9% (≥15%), the weight state is stable for 5 weeks, the gastroscope examination shows that the gastric mucosa is not inflamed or eroded, and the gastrointestinal peristalsis function is recovered to 85% (≥80%) of the preoperative function, and it is determined that the removal condition is met. Technical effect: through multi-dimensional joint determination of the removal time, the weight loss treatment goal is successfully achieved, and the patient's physical state is also ensured to meet the removal condition, avoiding rebound caused by premature removal or gastrointestinal damage caused by late removal, and improving the safety and stability of the balloon removal.

[0041] In some embodiments, long-term follow-up is performed at preset time nodes to monitor body weight and dietary status.

[0042] It should be understood that the necessary features are preset follow-up time nodes and core monitoring indicators, wherein the preset time nodes are set according to the high incidence period of weight rebound after weight loss, to ensure timely capture of weight change trend; weight monitoring is a direct indicator for evaluating the risk of rebound, and diet status monitoring can trace the cause of weight change; follow-up is achieved through regular reexamination of patients, and monitoring data is recorded and analyzed by medical staff, and the operation principle is "regular monitoring-data collection-risk assessment", which provides basis for subsequent intervention scheme adjustment. Exemplary explanation: the preset follow-up time nodes are 1 week, 1 month, 3 months, 6 months and 12 months after the balloon is taken out; after the patient takes out the balloon, regular reexamination is carried out according to the nodes, and medical staff measure weight, record food intake and diet structure every time follow-up; it is found that the patient's weight increases by 2% compared with the stable value after the balloon is taken out, and the proportion of high-calorie food in the diet increases at 1 month follow-up, so timely adjustment of the diet structure is reminded; the weight fluctuation is controlled within 1% at 6 months follow-up, and the diet status is good. Technical effect: the long-term follow-up mechanism can track the weight and diet status of the patient in real time, find the risk of weight loss rebound in time and intervene, avoid treatment effect loss, ensure the long-term stability of the weight loss effect, and make up for the short board of the existing weight loss method that lacks postoperative long-term management.

[0043] Obviously, those skilled in the art can make various modifications and variations to the present application without departing from the spirit and scope of the present application. Thus, if these modifications and variations of the present application belong to the scope of the claims of the present application and their equivalent technologies, the present application also intends to include these modifications and variations.

Claims

1. A method for intragastric weight loss based on an adjustable-volume balloon, characterized in that, Includes the following steps: Body mass index, gastric capacity, and gastrointestinal function indicators were measured in the target patients, and suitable target patients were selected based on the test results. Prepare a sterile adjustable-volume weight-reduction balloon and related infusion consumables. Insert the folded weight-reduction balloon into the designated location in the patient's stomach cavity using a gastroscopy. Inject sterile saline through the balloon's infusion channel to inflate the balloon to the preset initial volume, and monitor the inflation pressure in real time during the injection process. Monitor the rate of weight change, diet tolerance, and gastrointestinal response of the target patients; Regular imaging examinations are used to confirm the stability of the balloon position and to monitor the condition of the gastric mucosa. The initial volume of the balloon is then dynamically adjusted based on the monitoring data. When the target patient's weight loss rate reaches a preset range and the diet tolerance meets a preset standard, a preset concentration of degradation medium is injected through a dedicated balloon channel to control the injection volume and duration of action. After volume reduction, the balloon seal, intragastric pressure, and patient tolerance are monitored again, and the decision to proceed to the next volume reduction cycle is made based on the volume reduction effect. Once the balloon volume is reduced to the minimum suitable value and the target patient's weight reaches the target range and remains stable for the preset duration, the weight loss balloon is removed via gastroscopy. A long-term follow-up mechanism is established to regularly monitor weight, metabolic indicators, and dietary behavior. Based on the follow-up data, the risk of weight rebound is assessed, and the diet and exercise intervention plan is dynamically adjusted.

2. The method for intragastric weight loss based on an adjustable-volume balloon according to claim 1, characterized in that, The testing of body mass index, gastric capacity, and gastrointestinal function indicators in the target patient includes: Preoperative testing indicators must meet the requirement that BMI is greater than or equal to a preset lower threshold. Stomach capacity is within the preset threshold range, liver and kidney function indicators are within the normal reference threshold range, and coagulation function indicators meet the preset standard threshold.

3. The method for intragastric weight loss based on an adjustable-volume balloon according to claim 2, characterized in that, The initial volume of the balloon is set according to a preset proportional threshold of the target patient's gastric capacity, and the filling pressure is maintained within a preset pressure threshold range. Injection is automatically stopped when the pressure exceeds a preset upper limit threshold. The sealing test uses the pressure maintenance method. When the pressure maintenance time reaches the preset time threshold and there is no pressure drop, the seal is deemed qualified.

4. The method for intragastric weight loss based on an adjustable-volume balloon according to claim 3, characterized in that, Volume reduction is initiated when the target patient's weekly weight loss rate reaches a preset threshold range, and the patient's dietary intake remains stable within a preset percentage threshold range for a preset number of consecutive weeks, and there is no persistent gastrointestinal discomfort.

5. The method for intragastric weight loss based on an adjustable-volume balloon according to claim 4, characterized in that, During volume reduction, the pH value and concentration of the degradation medium are both within a preset threshold range, and the single injection volume is calculated according to a preset multiple threshold of the target volume reduction value. The action time of the degradation medium is controlled within a preset time threshold. The volume reduction effect is determined by monitoring the pressure change inside the balloon. The volume reduction is considered to have met the standard when the pressure drops to a preset ratio threshold.

6. The method for intragastric weight loss based on an adjustable-volume balloon according to claim 5, characterized in that, The balloon infusion solution must be reused to meet the following requirements: The number of docking attempts is greater than or equal to a preset threshold, the pass rate of the sealing test after each docking attempt reaches a preset percentage threshold, the elastic recovery rate of the channel self-sealing structure is greater than or equal to a preset percentage threshold, and there is no liquid leakage or the leakage amount is less than or equal to a preset trace threshold.

7. The method for intragastric weight loss based on an adjustable-volume balloon according to claim 6, characterized in that, The initial volume of the balloon is dynamically adjusted based on monitoring data and proceeds in preset stages. The single intake and the number of meals per day in each stage meet the corresponding preset thresholds.

8. The method for intragastric weight loss based on an adjustable-volume balloon according to claim 7, characterized in that, The balloon is reduced in volume at intervals within a preset time threshold. Each reduction is a preset percentage threshold of the current balloon volume. The cumulative number of reductions does not exceed a preset number threshold, and the final minimum balloon volume is not lower than a preset lower limit threshold. If the weight rebounds after reduction and exceeds the preset percentage threshold, the reduction amount is adjusted for the next reduction.

9. A method for intragastric weight loss based on an adjustable-volume balloon according to claim 8, characterized in that, The balloon is removed when its volume drops to a preset threshold range, the target patient's BMI drops below a preset upper threshold or the weight loss is greater than or equal to a preset percentage threshold, the patient's weight is stable for a duration greater than or equal to a preset duration threshold, the gastric mucosa is normal, and the gastrointestinal function recovers to a level above a preset percentage threshold.

10. A method for intragastric weight loss based on an adjustable-volume balloon according to claim 9, characterized in that, Long-term follow-up will be conducted at preset time points to monitor weight and dietary status.

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