Intelligent controllable intragastric weight-losing balloon system

Abstract

The invention relates to the technical field of medical instruments, and mainly discloses an intelligent controllable intragastric weight-losing balloon system which is structurally characterized in that a channel is formed in the wall of a balloon, and a blocking body is embedded in the channel. The plugging body is divided into a temperature-sensitive plugging body and a magnetic-sensitive plugging body, the temperature-sensitive plugging body is made of a non-degradable material with the melting point of 38-57 DEG C, and the magnetic-sensitive plugging body is formed by combining the non-degradable material with the melting point of 38-350 DEG C and a magnetic-sensitive material. When the balloon is in an implanted state, namely the blocking body is in a solid state, the channel can be tightly sealed by the blocking body. When the balloon is implanted into the stomach for a certain time and needs to be discharged, the hot drink is orally taken to increase the temperature in the stomach, or an alternating magnetic field is applied in vitro to melt the blocking body and lose the effect of blocking the channel, the liquid in the balloon is discharged, and the balloon can be discharged out of the body along the intestinal tract. The intelligent weight losing device is simple and reliable in structure, low in cost, intelligent and controllable, and can provide better weight losing experience and weight losing effect for patients.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an intelligent and controllable intragastric weight loss balloon system. Background Technology

[0002] With changing lifestyles (high-calorie diets, sedentary lifestyles, etc.), the global obese population is experiencing explosive growth. In my country, obesity has entered a high-incidence period, and the number of obese people is expected to exceed 200 million in the next few years. Obesity is not simply a matter of body shape, but a significant contributing factor to many chronic diseases: directly related diseases include type 2 diabetes, hypertension, hyperlipidemia, fatty liver, and obstructive sleep apnea syndrome; long-term risks include a significantly increased probability of cardiovascular and cerebrovascular diseases (such as coronary heart disease and stroke), certain tumors (such as breast cancer and colon cancer), and infertility. Obesity not only threatens individual health but also places a heavy burden on healthcare systems and the socio-economic system due to the need for chronic disease treatment, making it one of the "number one challenges" in global public health.

[0003] Currently, there are numerous weight loss methods. In order of effectiveness, the globally recognized medical weight loss methods are: diet combined with exercise, weight loss drugs, non-invasive weight loss devices such as gastric balloons, and bariatric surgery. Bariatric surgery has the best efficacy but the most side effects; diet combined with exercise has the fewest side effects and the lowest efficacy; gastric balloons are more effective than drugs but less effective than surgery, with fewer side effects than both drugs and surgery. Compared to weight loss drugs, gastric balloons are faster-acting and do not have long-term negative effects on the body (such as the potential risks of tumors and depression associated with drugs), and treatment is also more convenient. Due to its safety, simplicity, effectiveness, and reversibility, the gastric balloon system has enormous market potential and has therefore received widespread attention.

[0004] The principle behind intragastric balloon weight loss is that the balloon occupies part of the stomach's contents, delaying gastric emptying, stimulating central pressure receptors to create a feeling of fullness, reducing food cravings, and decreasing food intake, thus achieving the therapeutic goal of rapid weight loss. Generally, weight loss balloons placed in the stomach for 4-6 months can reduce body weight by 10%-20%. To date, weight loss balloons have evolved into the following generations: First Generation: Traditional balloons implanted via endoscopy. Representative products: Orebera, Obalon, and ReShapeDuo approved by the US FDA; Orebera, Obalon, ReShapeDuo, and Heliospherebag balloons approved in Europe (EU). Key features: Both implantation and removal of the balloon rely on endoscopy. During implantation, the balloon is inserted into the stomach and inflated using a gastroscope; during removal, the balloon fluid is first aspirated via endoscopy, and then the deflated balloon is removed through the esophagus. Advantages: The entire procedure is performed by a professional physician, and the implantation and removal times can be controlled. Disadvantages: Both implantation and removal require endoscopic anesthesia, making it an invasive procedure that may cause nausea, vomiting, throat injury, and other anesthesia and endoscopy-related side effects; patient tolerance for invasive procedures is low.

[0005] Second Generation: Adjustable-Volume Balloon. Representative Product: EU Spatz3 Balloon. Core Features: The balloon body has an adjustable-volume tubular section. Doctors can pull this tubular section out of the stomach through a gastroscope and inject or withdraw fluid into the balloon to flexibly adjust its volume. For example, if patients experience intolerance in the early stages of implantation, some fluid can be withdrawn to reduce the volume; if weight loss effects decrease, fluid can be injected to increase the volume and enhance satiety. Advantages: Solves the problem of fixed volume in first-generation balloons, improving patient adaptability (reducing initial intolerance); the volume can be dynamically adjusted according to weight loss results, resulting in better weight loss. Disadvantages: Balloon volume adjustment still requires anesthesia and is performed endoscopically, which is an invasive procedure, and patient compliance remains low.

[0006] Third Generation: Swallowable, Non-surgical Balloon. Representative Product: Allurion Balloon (USA). Key Features: The balloon is compressed into a capsule shape, which the patient can swallow directly into the stomach. Water (approximately 550ml) is then injected into the capsule via an external device to inflate the balloon. The balloon contains a pressure relief valve made of biodegradable material. Approximately 4 months after implantation, the material naturally degrades, the valve opens, the balloon deflates after the fluid flows out, and the contents are naturally expelled through the intestines. Advantages: No endoscopy or anesthesia is required throughout the procedure; it is a non-invasive procedure. The incidence of adverse events is reduced by 93%-95% compared to traditional balloon endoscopy, resulting in high patient acceptance. Clinical data shows that over 150,000 people have used it, resulting in a cumulative weight loss of nearly 2 million kg, validating its safety and basic weight loss effectiveness. Disadvantages: The decompression time is entirely preset by the biodegradable material (fixed at 4 months), and the removal time cannot be flexibly adjusted according to the patient's weight loss progress; the balloon volume cannot be adjusted during implantation, and the weight loss effect is weaker than the second generation (which can dynamically adjust the volume); the implanted balloon volume is large, and the patient's initial discomfort (nausea, vomiting, abdominal distension, abdominal pain) is strong; if the patient has severe intolerance or special complications, it still needs to be removed by gastroscopy under anesthesia, and the emergency needs of invasive operation cannot be completely eliminated.

[0007] Allurion's swallowable, non-endoscopic balloon, as a third-generation intragastric weight-loss balloon, is designed to meet two core requirements: a sufficiently small pre-implantation size (compressible into a capsule for easy swallowing) and a reliable automatic decompression device after implantation (ensuring the balloon collapses and is naturally expelled through the intestines after the fluid is emptied). Because biodegradable materials lack stability in the harsh environment of the stomach (hydrochloric acid, pepsin, mechanical peristalsis, food, temperature fluctuations, etc.) (easily degrading or failing prematurely), the mainstream balloon materials are currently non-biodegradable (such as Spatz3's silicone rubber and Allurion's polyurethane). For non-biodegradable balloons, a specialized "emptying device" is required to empty the fluid, allowing the collapsed balloon to be expelled through the intestines.

[0008] To address this need, several patents have proposed different solutions, all centered around the design of the "trigger mechanism" and "environmental resistance of the device" for biodegradable materials, as detailed below: Chinese patent CN210330838U discloses a weight-loss balloon with an absorbable valve; Chinese patent CN116849892A discloses a balloon release valve and an intragastric balloon; Chinese patent CN118415803A discloses an integrated valve, an intragastric balloon, its preparation method, and a weight-loss balloon kit; Chinese patent CN108852578A discloses a biodegradable implant; Chinese patent CN116212124A discloses a biodegradable self-sealing valve for an intragastric balloon, its preparation method, and its application; Chinese patent CN223041681U discloses an intragastric balloon device; Chinese patent CN117547390A discloses a balloon system for releasing fluid in the stomach; Chinese patent CN116942389A discloses an intragastric balloon release valve, its preparation method, and an intragastric balloon; US patent US10238516B1 discloses a simplified implantable gastric balloon system with self-sealing valve. Flatingtimer (a simplified implantable gastric balloon system with a self-deflating timer). The above patents utilize biodegradable materials with different structures. Within a predetermined timeframe, the biodegradable materials degrade, losing their ability to block the passage, opening the valve or passage, and allowing liquid or gas to leak out of the balloon.

[0009] Chinese patent CN110448398B discloses a method and apparatus for unfolding and releasing a temporary implant in the body: allowing the device to unfold to a volume occupying the space of the stomach and, after a period of effective time, delivering substances or stimuli to initiate the decomposition of the expanding device so that it can be released from the body. As described in paragraphs

[0104] -

[0139] , an embodiment using biodegradable materials as release materials is disclosed, with the following key points: 1) Material and structure: The release channel (second fluid channel) and the balloon (first fluid container) are made of the same material and are integrated into one unit; 2) Overlapping design: The release channel adopts a "reverse folding and overlapping" structure, that is, it is folded back and inserted into the balloon, in order to avoid direct contact between the biodegradable suture and gastric juice, and to prevent the suture from degrading out of control due to the action of gastric juice; 3) Sealing mechanism: Papillary protrusions are formed inside the overlapping structure, and sutures made of biodegradable materials (such as PCL) are wrapped around it. The release channel is sealed by "winding and tightening" to achieve the sealing of the balloon; 4) Triggering liquid release principle: When the suture breaks naturally due to degradation, or when the suture is melted by external heat, the restriction of the release channel is released, the channel is opened, and the fluid in the balloon is depressurized. However, the aforementioned patents have the following drawbacks: 1) Material limitations: Only sutures (or films, filaments) made of biodegradable materials with mechanical strength can be used to achieve a seal around the release channel by "wrapping" it in a binding manner; 2) Temperature control challenges: The melting point of sutures made of biodegradable materials is relatively high, with PCL sutures having the lowest melting point, ranging from 59℃ to 64℃, and the melting point gradually decreases as the material degrades until it falls below 37℃. If external heat is used to activate the release channel, liquids above 60℃ must be introduced when the melting point is high, which will inevitably burn the stomach tissue. The suitable temperature for human consumption is 38-50℃; after the melting point decreases with degradation, it may be mistakenly triggered by the temperature of food or triggered automatically, making precise temperature control impossible; 3) Structural and process issues: The complex "nested" structure design of the release channel results in a large overall volume, which may affect the suitability of the capsule for implantation; 4) Biodegradable materials may degrade before implantation (during transportation and storage) and after implantation, requiring strict environmental control (such as avoiding high temperatures), which increases the storage and transportation costs of the product, and requires high process stability. Summary of the Invention

[0010] This invention addresses the technical problems of "fixed and unadjustable time" in third-generation balloons and "invasive operation" in second-generation balloons in existing technologies. It provides an intelligent and controllable intragastric weight loss balloon system. By setting a channel on the balloon and embedding an obstruction body in the channel, the obstruction body is made of a physicochemically stable and non-degradable material with a sensitive melting point range. This achieves a technological leap from "passive waiting" to "intelligent controllability" and provides a new solution for obesity treatment that combines "precise control" and "patient-friendly" characteristics.

[0011] To achieve the above objectives, the present invention adopts the following technical solution: an intelligent and controllable intragastric weight loss balloon system, comprising at least one channel on the balloon wall and a plug embedded in the channel. The plug is made of a non-degradable material with a melting point of 38℃-350℃, and the channel is opened by utilizing only the phase change of the material from solid to liquid. The plug has a sensitive melting point and can easily trigger the balloon to release pressure. The non-degradable material in this patent is defined as follows: during the service life of the product of the present invention, the plug material does not degrade and does not affect the performance of the product due to degradation factors, including not affecting the performance of the blocked channel and not affecting the temperature-sensitive characteristics of the material.

[0012] System stability verification: The system reliability was verified through experiments simulating the human stomach environment.

[0013] Stability under normal physiological conditions: After injecting 600ml of physiological saline into the balloon system prepared in this patent, it was placed in a hydrochloric acid water bath at 37℃-38℃ and pH=2 for 6 months. The test results were as follows: 1) Implantation reliability: The balloon did not depressurize; 2) Thermosensitive stability: For occluders with a temperature of 38℃-57℃, the balloon did not depressurize after being placed in a water bath at 2.0℃ below the melting point of the non-degradable material for 1 hour; 3) Thermosensitive depressurization: For occluders with a temperature of 38℃-57℃, the occluder melted within 10 minutes and the liquid in the balloon flowed out. The balloon depressurized within 3 hours. For magnetically sensitive occluders with a temperature of 58℃-350℃, an alternating magnetic field was applied externally, and the magnetically sensitive body heated up. When the temperature of the occluder exceeded the melting point of the magnetically sensitive body, the liquid in the balloon flowed out. The balloon depressurized within 3 hours.

[0014] The specific design of the blocking body (core implementation method): As a key execution component of the system, the blocking body is the core of achieving "intelligent controllability". Its design details and triggering mechanism are as follows: One technical solution for implementing this invention is as follows: the blockage body is a temperature-sensitive blockage body, and its mechanism is to directly absorb heat from the external environment, causing the blockage body to melt. This includes the patient drinking a fluid with a temperature higher than its melting point, raising the temperature inside the stomach, causing the blockage body to melt, and triggering balloon decompression.

[0015] The melting point of the non-degradable material in the blockage is 38℃-57℃ (basic range). The melting point of the non-degradable material needs to be higher than the normal human body temperature of 37℃ to avoid accidental triggering. Preferably, the melting point of the non-degradable material is 45℃-55℃. More preferably, the melting point of the non-degradable material is 48℃-52℃. Avoiding excessively low melting points (such as below 45℃) can prevent the blockage from melting prematurely due to the consumption of warm food (such as room temperature food or warm soup), reducing the strict restriction on the temperature of food consumed by the patient. Avoiding excessively high melting points (such as above 57℃) can trigger pressure relief without drinking excessively hot liquids, reducing the risk of hot liquids scalding the esophagus and gastric mucosa.

[0016] Furthermore, in this technical solution, the non-degradable material is selected from at least one of the following: Organic hydrocarbon compounds: n-dodecane (43℃-46℃), n-tetracosane (49℃-52℃), n-hexadecane (56-58℃), paraffin (48℃-50℃), paraffin (50℃-52℃), paraffin (52℃-54℃), paraffin (54-56℃); Organic alcohol compounds: pentadecyl alcohol (43℃), hexadecyl alcohol (49.6℃); n-hexanol (57℃); Organic acid compounds: lauric acid (44℃-46℃), oleic acid (44℃-45℃); Polymer: PEG with molecular weights of 1500 and 2000 corresponds to melting points of (44℃-48℃) and (53℃-57℃), respectively.

[0017] Furthermore, the plug is preferably installed on the surface of the balloon or in a channel outside the balloon, which is beneficial for absorbing heat from the stomach and melting it.

[0018] Furthermore, a heat conductor is embedded in the channel leading to the outside of the balloon at the downstream end of the blockage body. The heat conductor plays a role in heat transfer, which is more conducive to the blockage body absorbing heat from the stomach. A heat insulator is embedded in the channel leading to the inside of the balloon at the upstream end of the blockage body. The heat insulator plays a role in heat insulation, which prevents the liquid inside the balloon from contacting the blockage body and facilitates the melting of the blockage body.

[0019] Furthermore, the channel is embedded with a heat conductor and a heat insulator, which can protect the blockage from environmental factors.

[0020] Furthermore, the heat conductor includes thermally conductive grease or thermally conductive silicone, and the heat insulation material includes one of plastic, rubber, and sponge.

[0021] Another technical solution to achieve the present invention is: the plug is a magnetically sensitive plug, and the material of the plug also includes a magnetically sensitive material. The mechanism is that the magnetically sensitive material converts electromagnetic energy into heat energy in an alternating magnetic field, causing the local temperature of the plug to rise to the phase transition critical point of the non-degradable material, causing the plug to melt and triggering the balloon to depressurize.

[0022] The non-degradable material has a melting point of 38℃-350℃ (basic range). The plug is installed inside the balloon, and because the plug is very small and has a low heat content, even if the plug reaches a high temperature of 350℃, after melting, it cools down quickly upon contact with gastric fluid and balloon discharge, preventing damage to the stomach wall. Preferably, the melting point of the non-degradable material is 50℃-150℃; more preferably, the melting point of the non-degradable material is 60℃-98℃. Temperatures above 60℃ are unaffected by food temperature, and temperatures below 95℃ are below the boiling point of water, ensuring good safety.

[0023] Furthermore, in this technical solution, the non-degradable material of the plug is selected from at least one of the following: Organic hydrocarbon compounds: paraffin (57℃-74℃), n-hexadecane (56℃-58℃), n-triane (65.8℃), naphthalene (80.1℃), anthracene (215℃), phenanthrene (98℃-100℃), n-tetracosane; Organic acid compounds: stearic acid (67℃-72℃), triacontamic acid (93℃), benzoic acid (122.13℃), terephthalic acid (261.9℃), phthalic acid (210℃-211℃), gallic acid; Amide compounds: Urea (132℃-135℃); Organic alcohol compounds: pentadecyl alcohol, hexadecyl alcohol, n-hexanol, octadecanol, pentaerythritol, sorbitol, xylitol; Organic aldehydes: glucose; High molecular polymers: PE (85℃-136℃), PP (164℃-176℃), PVC (212℃), PS (240℃), PC (250℃-260℃), PA (220℃-280℃), PTFE (327℃), PEEK (343℃), PI (334℃), PHA (40℃-190℃), PU (170℃-190℃), and modified high molecular polymers.

[0024] The magnetic sensitive material is selected from at least one of the following: Magnetic materials: manganese-zinc ferrite, nickel-zinc ferrite; pure iron, nickel, neodymium iron boron; iron(II,III) oxide, gamma iron(II,III) oxide; Non-magnetic materials: graphite, carbon fiber composites; Preferably, the magnetic material in this technical solution is iron(III) oxide or gamma-iron(III) oxide; preferably, the non-magnetic material is graphite.

[0025] Furthermore, in this technical solution, the plugging body is preferably installed inside the balloon because the plugging body absorbs the energy of the external magnetic field and generates heat, rather than absorbing external heat, making it safer to install it inside the balloon.

[0026] Furthermore, in this technical solution, heat insulation materials are provided in the channels at both the upstream and downstream ends of the blockage body, which facilitates the heating and melting of the blockage body and at the same time protects the blockage body from environmental influences. The heat insulation materials are made of one of plastic, rubber, or sponge.

[0027] Furthermore, the channel is equipped with heat insulation materials upstream and downstream of the embedded blockage body, which can protect the blockage body from environmental factors.

[0028] Some non-degradable materials are water-soluble. When using these water-soluble non-degradable materials, two methods can be used to prevent the gastric fluid or balloon fluid from affecting the plug. First, the water-soluble non-degradable material is coated with another non-water-soluble non-degradable material. Second, heat conductors and insulators can prevent the balloon fluid from contacting the plug, protecting the plug made of water-soluble non-degradable material from the influence of environmental factors.

[0029] A further technical solution to achieve the present invention is that: the channel is an internal cavity formed by a tubular body made of metal or non-metal materials. Metal materials include copper, aluminum, and stainless steel; non-metal materials include plastics and rubber. Plastic materials include PE, PP, PVC, PS, PC, PA, POM, PBT, PTFE, PEEK, PI, PHA, PBAT, PMMA, PU, ​​PET, ABS, EP, PF, and UP; rubber materials include silicone rubber, polyurethane, natural rubber, EVA, and silicone-modified polyurethane rubber, etc. Preferably, the same elastomer material as the balloon is used.

[0030] Furthermore, the cross-section of the channel is one of the following: circular, square, trapezoidal, elliptical, or polygonal. Preferably, the cross-section of the channel is circular with a diameter of 0.1mm-20mm, more preferably 0.3mm-5.0mm, and even more preferably 0.5mm-2.0mm.

[0031] Furthermore, the upstream end of the channel is connected to a drainage tube extending into the balloon. Drainage holes are evenly distributed on the side wall of the drainage tube. Even if the balloon is folded, the drainage tube can completely drain the liquid, ensuring that the balloon completely drains the liquid and is naturally discharged with the intestines without causing intestinal obstruction.

[0032] Compared with the prior art, the beneficial effects of the present invention are: 1) Autonomous control of discharge timing: With the cooperation of the channel and the blockage body, when drinking liquids at a specific temperature or applying an alternating magnetic field, the blockage body is caused to melt rapidly due to the increase in temperature, breaking the seal and allowing the balloon to be discharged as needed, no longer passively relying on degradation time.

[0033] 2) Characteristics and material advantages of the plugging body: The plugging body can be a tiny solid used to block the passage. Its non-degradable materials are widely available, and it is easy to select materials with a sensitive melting point. The melting range is only 0.5℃-2℃, which can reliably and predictably trigger the response at a specific temperature, improving accuracy and controllability. At the same time, the plugging body melts into a liquid, which can flow out from the passage completely, keeping the passage open and ensuring complete drainage of the balloon, avoiding balloon retention and intestinal obstruction.

[0034] 3) The structure is simple, reliable, controllable, and low-cost, laying an economic foundation for multiple balloon replacements.

[0035] 4) Advantages of the microstructure: The microstructure formed by the channel and the blockage can keep the millimeter-level channel open, ensuring complete drainage of the fluid in the balloon and reducing the risk of intestinal obstruction; it can also make the balloon smaller, making it easier to swallow.

[0036] 5) Innovative medical solution: Stepped volume adjustment, through progressive implantation of "small volume starting → large volume enhancement", reduces initial discomfort while ensuring long-term weight loss effect; reduces safety risks, the balloon is expelled, and high-risk patients can be targeted for screening through gastroscopy, which can detect hidden complications such as gastritis and gastric ulcers at an early stage, and avoid disease progression (long-term pressure from the balloon may aggravate mucosal damage). It realizes "expulsion-examination-assessment-adjustment" to ensure safety and effectiveness. Attached Figure Description

[0037] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0038] Figure 1 This is a schematic diagram of the intelligent controllable intragastric weight loss balloon system in Embodiment 1 of the present invention; Figure 2 This is a schematic diagram of the intelligent controllable intragastric weight loss balloon system in Embodiment 2 of the present invention; Figure 3 This is a schematic diagram of the intelligent controllable intragastric weight loss balloon system in Embodiment 3 of the present invention; Figure 4 This is a schematic diagram of the intelligent controllable intragastric weight loss balloon system in Embodiment 4 of the present invention.

[0039] In the diagram: 101, balloon; 102, plug; 103, channel; 104, heat conductor; 105, insulation; 106, drain hole; 107, drainage tube. Detailed Implementation

[0040] To better understand the above technical solutions, the following will provide a detailed explanation of the technical solutions in conjunction with the accompanying drawings and specific implementation methods.

[0041] Example 1 like Figure 1 As shown, this embodiment is an intelligent and controllable intragastric weight loss balloon system, including a balloon made of polyurethane elastomer material. The balloon has a channel, and a plug made of a non-degradable material at 38℃-57℃ is embedded in the channel to form a pressure relief valve.

[0042] In this embodiment, the channel is a cylindrical inner cavity formed by a tubular body made of polyurethane material, and the tubular body is located outside the balloon. In this embodiment, the occluder is embedded in the channel outside the balloon.

[0043] In this embodiment, the diameter of the tubular body is 1.0 mm. The plug is cylindrical with a diameter of 1.5 mm. The size of the plug is larger than the size of the channel to increase the friction between the plug and the channel, preventing the plug from falling out of the channel.

[0044] When the balloon system in this embodiment is used, the following steps are included: 1) Channel preparation: Select the same elastomer material as the balloon (e.g., polyurethane material), extrude the tubular body with an extruder, cut it into segments, and use the internal cavity of the tubular body as the channel; 2) Block preparation: Different non-degradable materials are melted, injected into the corresponding molds, cooled, removed, and finally cut into segments as block materials; 3) Preparation of the channel-embedded plug: The plug is pushed into the channel of the tubular body by external force; 4) Tubular body bonded to balloon: A round hole (1.5 mm in diameter) is drilled through the balloon, and the tubular body is passed through the balloon and bonded with adhesive; 5) The balloon system is compressed into capsules, sterilized, packaged, and stored for later use; 6) Clinical Application: The balloon system prepared above is swallowed into the stomach. 400ml-700ml of liquid is injected through the catheter and the one-way valve of the balloon system. After removing the catheter, the balloon system remains in the stomach, occupying gastric volume and reducing stomach size. When the patient drinks liquid with a temperature 0.5℃-2℃ higher than the melting point of the non-degradable material, the non-degradable material will melt, and the balloon will expel the liquid from the body. The patient's diet is controlled to be 0.5°C - 2°C below the melting point of the non-degradable material, and the balloon system is safe. 7) Balloon adjustment: Based on the comprehensive judgment of the patient's physical sensations and effects after implantation, determine the implantation time of the balloon. For those with severe discomfort, the implantation can be terminated in advance, or a balloon with a smaller volume can be implanted again; for those with a deteriorating weight loss effect after implantation for a period of time, a balloon with a larger volume can be replaced.

[0045] For the balloon system prepared in Example 1, different non-degradable materials are used to prepare the blocking body, and the gastric environment is simulated: 600 ml of normal saline is injected into the balloon, and it is placed in a hydrochloric acid water bath at 37°C - 38°C (body temperature) and pH = 2 for 6 months for experimental testing.

[0046] The following items are tested: 1) Implantation reliability: It is qualified if the balloon does not deflate, proving that the blocking body does not degrade, decompose, acidolyze, or dissolve, and still maintains the blocking function. 2) Thermosensitive stability: After the balloon is kept at a constant temperature of 37°C, it is placed in a water bath 2.0°C below the melting temperature of the non-degradable material of the blocking body for 1 hour, and still remains in a non-deflated state, proving that the blocking body is sensitive and stable to temperature, and avoiding accidental deflation due to temperature fluctuations (mainly diet temperature). 3) Thermosensitive deflation: After the balloon is kept at a constant temperature of 37°C, it is placed in a water bath 2.0°C above the melting temperature of the non-degradable material of the blocking body. Within 10 minutes, the blocking body melts, and the normal saline in the balloon flows out. Then the balloon is placed in a plastic funnel with the channel facing downwards, and it is qualified if the liquid in the balloon drains out within 3 hours. The test data is shown in Table 1.

[0047]

[0048] Table 1. Test data of the balloon in Example 1 Partial sources of the materials in Table 1: 1) Paraffin: Sectioning paraffin (48°C - 50°C), paraffin (50°C - 52°C), paraffin (52°C - 54°C), paraffin (54°C - 56°C): Sinopharm Chemical Reagent Co., Ltd.; 2) PEG2000, 4000, 6000, 8000, 10000: Shanghai Macklin Biochemical Co., Ltd.; 3) Cetyl alcohol (50°C): Sinopharm Chemical Reagent Co., Ltd.; 4) Lauric acid (44°C - 46°C): Shanghai Macklin Biochemical Co., Ltd.; 5) n-Tetracosane; Guangdong Xingfu Chemical Reagent Co., Ltd.

[0049] Example 2 As Figure 2As shown, this embodiment is an intelligent and controllable intragastric weight loss balloon system, including a balloon made of polyurethane elastomer material. The balloon has a channel, and a temperature-sensitive plug made of non-degradable material is embedded in the channel to form a pressure relief valve.

[0050] In this embodiment, the channel is a cylindrical cavity formed within a tubular body made of medical-grade PVC material. The tubular body is located outside the balloon, and the temperature-sensitive occluder is embedded within the channel outside the balloon. The diameter of the tubular body is 2.0 mm.

[0051] In this embodiment, a heat conductor is embedded in the channel at the downstream end of the blockage body, and a heat insulator is embedded in the channel at the upstream end of the blockage body. The heat conductor is made of thermally conductive silicone grease, and the heat insulator is made of heat-insulating sponge. Their shapes are not limited. The heat conductor and the heat insulator ensure the channel is sealed after being embedded in the channel.

[0052] When the balloon system in this embodiment is used, the following steps are included: 1) Channel preparation: Medical PVC granules are selected, and tubular bodies are extruded using an extruder and cut into the required length; 2) Block preparation: Different non-degradable materials are melted into liquid, injected into the channel of the tubular body with a syringe, cooled to form a block, and finally cut into segments as block. 3) Add thermally conductive silicone grease and insulating sponge to the channel: Inject thermally conductive silicone grease into the downstream end of the plug in the channel of the tubular body, and embed sponge plug into the upstream end of the plug in the channel of the tubular body; 4) Tubular channel bonded to balloon: A round hole (2.5 mm in diameter) is drilled through the balloon, and the tubular channel is bonded to it with adhesive after passing through the balloon; 5) The tubular body and the balloon are compressed together to prepare capsules, which are then packaged, sterilized, inspected, and stored for later use; 6) Clinical application: The doctor instructs the patient to swallow the balloon into the stomach, then injects liquid, causing the balloon to inflate into a water balloon that occupies the stomach contents. 7) Balloon removal: When the balloon needs to be removed after being implanted in the stomach for a certain period of time, hot water at a temperature 2°C higher than the melting point of the non-degradable material can be drunk to melt the blockage, turning it from a solid to a liquid state and losing its ability to block the passage. Under the pressure of the liquid inside the balloon, the melted blockage, sponge plug, and thermally conductive silicone grease flow out of the passage together, and the liquid inside the balloon leaks out and is expelled from the body through the intestines.

[0053] The balloon system prepared in Example 2 was modified by using different non-degradable materials to prepare the plug, simulating the gastric environment: 600 ml of physiological saline was injected into the balloon and placed in a hydrochloric acid water bath at 37℃-38℃ (body temperature) and pH=2 for 6 months.

[0054] The test will examine the following items: 1) Implant reliability: The balloon not deflating is considered qualified, proving that the thermosensitive plugging body does not degrade, decompose, acidolyze, or dissolve, and still maintains the plugging function; 2) Thermosensitive stability: After the balloon is kept at a constant temperature of 37°C, it is placed in a water bath at 2.0°C below the melting temperature of the non-degradable material for 1 hour. The balloon not deflating is considered qualified; 3) Thermosensitive pressure relief: After the balloon is kept at a constant temperature of 37°C, it is placed in a water bath at 2.0°C above the melting temperature of the non-degradable material. Within 10 minutes, the plugging body melts, and the liquid inside the balloon leaks out. Then the balloon is placed in a plastic funnel with the channel facing downwards. The liquid in the balloon finishes leaking within 3 hours is considered qualified. The test data is shown in Table 2.

[0055]

[0056] Table 2. Test data of the balloon in Example 2 Sources of some materials in Table 2: 1) Paraffin: Sectioning paraffin (52°C - 54°C), paraffin (54°C - 56°C): Sinopharm Chemical Reagent Co., Ltd.; 2) PEG2000, 4000, 6000, 8000, 10000: Shanghai Macklin Biochemical Co., Ltd.; 3) Cetyl alcohol (46°C): Sinopharm Chemical Reagent Co., Ltd.; 4) Lauric acid (44°C - 46°C): Shanghai Macklin Biochemical Co., Ltd.; 5) n-Hexacosane: Guangdong Xingfu Chemical Reagent Co., Ltd.; 6) Thermal conductive silicone grease: Dow Corning, USA, TC-502.

[0057] Example 3 As Figure 3 shown, this example is an intelligent controllable gastric weight loss balloon system, including a balloon made of polyurethane elastomer material. There are 2 channels provided on the balloon, and a plugging body made of non-degradable material and magnetic sensitive material is embedded in the channel to form a pressure relief valve.

[0058] In this example, the plugging body is composed of a mixture of non-degradable material and magnetic sensitive material. The shape of the plugging body is spherical or ellipsoidal.

[0059] The channel in this example is a cylindrical channel formed inside a tubular body made of polyurethane material. The diameter of the tubular body is 0.5 mm. The tubular body is located inside the balloon. The plugging body in this example is embedded in the channel inside the balloon.

[0060] The size of the cross-section of the plugging body is larger than the diameter of the channel.

[0061] When the balloon system in this embodiment is used, the following steps are included: 1) Channel preparation: Polyurethane material is selected, and a tubular body is extruded using an extruder. The body is then cut into segments, and the hollow cavity inside the tubular body serves as the channel. 2) Preparation of the plug: Select different non-degradable materials and mix them evenly with magnetic sensitive materials (Fe3O4 magnetic powder in this example) at a mass ratio of 1:1. Inject the mixture into a mold and cool it rapidly to prepare a plug with an ellipsoidal shape and a diameter larger than that of the tubular body. 3) Tubular bodies are bonded to the balloon: Two tubular bodies are bonded inside the balloon to form a channel; 4) The tubular body and the balloon are compressed together to prepare capsules, which are then packaged, sterilized, inspected, and stored for later use; 5) Clinical application: When the balloon needs to be removed after being implanted in the stomach for a certain period of time, an alternating strong magnetic field is applied outside the body. The magnetic sensitive material heats up and transfers the heat to the non-degradable material. When the melting temperature is reached, the non-degradable material changes from solid to liquid. Under the pressure of the liquid inside the balloon, the molten non-degradable material and the magnetic sensitive material flow out of the channel together. The pressure of the balloon decreases and it is expelled from the body through the intestine.

[0062] Magnetic materials generate eddy currents and hysteresis losses in alternating magnetic fields, thus producing heat. Temperature control in induction heating technology is crucial for safety and reliability. This invention allows for temperature regulation by adjusting the power supply frequency, current magnitude, and usage time, as well as the type, content, and distribution of the magnetically sensitive material. Experience can be accumulated through repeated experiments, and the depressurization of the balloon channel can be monitored in real-time using ultrasound or X-ray machines. Heating is immediately stopped upon depressurization, achieving more precise control over depressurization and meeting clinical requirements.

[0063] Example 3 prepared a balloon and a pressure relief valve. Different non-degradable materials and magnetite powder were used to create the plug, resulting in various designs. The gastric environment was simulated: the balloon was injected with 600ml of physiological saline and placed in a hydrochloric acid water bath at 37℃-38℃ (body temperature) and pH=2 for 6 months. The following tests were conducted: 1) Implantation reliability: The balloon does not depressurize, which proves that the magnetic occluder does not degrade, decompose, acidify, or dissolve, and still maintains its occlusive function; 2) Temperature-sensitive stability: This test is only performed on plugs made of non-degradable materials with a melting point below 64℃. After being kept at a constant temperature of 37℃, the balloon is placed in a water bath at 4.0℃ below the melting temperature of the non-degradable material for 1 hour. If the balloon does not depressurize, it is considered qualified. 3) Temperature-sensitive pressure relief property: Select an external magnetic field generator with a high-frequency alternating magnetic field frequency of 150 kHz, a distance of 50 cm between the two magnetic poles, and an adjustable current; place the balloon in a 37°C glass container water bath for constant temperature, and then place it in the middle of the magnetic field together. Adjust the current. Within 5 minutes, the magnetic-sensitive plug melts, and the physiological saline in the balloon flows out. Then place the balloon in a plastic funnel with the channel facing downwards. It is qualified if the liquid in the balloon drains completely within 3 hours. The test data is shown in Table 3.

[0064]

[0065] Table 3. Test data of the balloon in Example 3 Table 3 Material source: 1) Paraffin: Sinopharm Chemical Reagent Co., Ltd.: Sectioning paraffin (54 - 56°C); 2) PEG2000, 4000, 6000, 8000, 10000: Shanghai Macklin Biochemical Co., Ltd.; 3) Cetyl alcohol (46°C): Sinopharm Chemical Reagent Co., Ltd.,; 4) Lauric acid, n-Triacontane: Shanghai Macklin Biochemical Co., Ltd.; 5) Urea: Sinopharm Chemical Reagent Co., Ltd.; 6) Glucose: Fuchen (Tianjin) Chemical Reagent Co., Ltd.; 7) PET: DuPont Company, USA; 8) PU: BASF, Germany; 9) Ferroferric oxide nano micropowder: Beijing Zhongke Keyou Nanotechnology Co., Ltd.

[0066] Example 4 As Figure 4 shown, this example is an intelligent controllable gastric weight loss balloon system, including a balloon made of polyurethane elastomer material. A channel is provided on the balloon, and a plug made of non-degradable material and magnetic-sensitive material is embedded in the channel to form a pressure relief valve. The upstream end of the channel is connected to a drainage tube extending to the bottom of the other end of the balloon, and drainage holes are evenly distributed on the side wall of the drainage tube.

[0067] In this example, the channel is a cylindrical channel formed inside a tubular body made of polyurethane material, and the drainage tube is made of polyurethane material. The diameter of the tubular body is 1.5 mm, and the diameter of the drainage tube is 1.0 mm.

[0068] In this example, the plug is a cylinder.

[0069] ​​​In this embodiment, heat insulation materials are provided at both the upstream and downstream ends of the blockage body in the channel to isolate the fluid in the balloon and the fluid in the stomach from affecting the magnetically sensitive blockage body.

[0071] When the balloon system in this embodiment is used, the following steps are included: 1) Channel preparation: Polyurethane material is selected, and an inner drainage tube and a tubular body are extruded using an extruder. The drainage tube is cut into segments, and a channel is formed inside the tubular body. The drainage tube and the tubular body are bonded together, and drainage holes are evenly distributed on the side wall of the drainage tube. 2) Preparation of the plug: Select different non-degradable materials, melt them, and mix them evenly with magnetic sensitive materials (graphite powder is selected in this embodiment) at a mass ratio of 2:1. Inject the plastic strip (with an outer diameter of 1.7 mm) using an injection molding machine, and cut it into segments (with a length of 2 mm). Alternatively, the magnetic sensitive material can be a block made of graphite, with the block being circular in shape, and the above plastic strip is embedded inside to form a magnetic sensitive plug. 3) The blockage is pushed into the channel of the tubular body by external force; 4) One end of the tubular body is attached to the inside of the balloon, and the drainage tube extends all the way to the bottom of the other end inside the balloon; 5) Insulating sponge cylinders are embedded in the channels at the upstream and downstream ends of the plug. The outer diameter of the sponge plug is 1.5 mm and the length is 2.0 mm. 6) The tubular channel and the balloon are compressed together to prepare a capsule, which is then packaged, sterilized, inspected, and stored for later use; 7) Clinical application: When the balloon needs to be removed after being implanted in the stomach for a certain period of time, an alternating strong magnetic field is applied outside the body. The graphite powder heats up and is transferred to the non-degradable material. When the non-degradable material heats up to the melting temperature, it changes from solid to liquid. Under the pressure of the liquid inside the balloon, it rushes out of the channel along with the graphite powder or graphite block. The liquid inside the balloon is completely drained and discharged from the body through the intestine.

[0072] Example 4 describes the preparation of a balloon system. Various magnetically sensitive occluders were fabricated by modifying different non-degradable materials and graphite to simulate the gastric environment: the balloon was injected with 600 ml of physiological saline and placed in a hydrochloric acid bath at 37℃-38℃ (body temperature) and pH=2 for 6 months. The following tests were conducted: 1) Implantation reliability: The balloon does not depressurize, which proves that the magnetic occluder does not degrade, decompose, acidify, or dissolve, and still maintains its occlusive function; 2) Temperature-sensitive pressure relief property: Select an external magnetic field generator with a high-frequency alternating magnetic field frequency of 150 kHz, a distance of 50 cm between the two magnetic poles, and an adjustable current; place the balloon in a 37°C glass container water bath for constant temperature, then place it together in the middle of the magnetic field, adjust the current, and within 5 minutes, the magnetically sensitive plug melts, and the physiological saline in the balloon flows out. Then place the balloon in a plastic funnel with the channel facing downwards, and it is considered qualified if the liquid in the balloon drains out within 3 hours. The test data is shown in Table 4.

[0073]

[0074] Table 4. Test data of the balloon in Example 4 Sources of some materials in Table 4: 1) Xylitol, sorbitol: Tianjin Huasheng Reagent Co., Ltd.; 2) PE: China Petroleum & Chemical Corporation; 3) TPU: BASF SE (Germany); 4) PC: Covestro AG (Germany); 5) PTFE: DuPont de Nemours and Company (USA); 6) PEEK: Victrex plc (UK); 7) PS: Jiangsu Zhongxin Guoan New Materials Co., Ltd.; 8) PP: China Petroleum & Chemical Corporation; 9) Graphite: Tianjin Kemiou Chemical Reagent Co., Ltd..

[0075] For those skilled in the art, it is obvious that the present invention is not limited to the details of the above exemplary embodiments, and the present invention can be implemented in other specific forms without departing from the spirit or basic characteristics of the present invention. Therefore, from any point of view, the embodiments should be regarded as exemplary and non-restrictive. The scope of the present invention is defined by the appended claims rather than the above description. Therefore, all changes falling within the meaning and scope of the equivalent elements of the claims are intended to be embraced within the present invention. Any reference signs in the claims should not be regarded as limiting the claimed rights.

Claims

1. A smart and controllable intragastric weight loss balloon system, characterized in that: The invention includes a balloon made of elastomer and at least one channel disposed on the balloon wall, and a plug embedded in the channel, wherein the plug is made of a non-degradable material with a melting point of 38°C-350°C.

2. The intelligent controllable intragastric weight loss balloon system according to claim 1, characterized in that: The melting point of the non-degradable material in the plug is 38℃-57℃; preferably, the melting point of the non-degradable material is 45℃-55℃; preferably, the melting point of the non-degradable material is 48℃-52℃.

3. The intelligent controllable intragastric weight loss balloon system according to claim 2, characterized in that: The non-degradable material of the plug is selected from at least one of the following: Organic hydrocarbon compounds: n-docosane, n-tetracosane, n-hexacosane, paraffin; Organic alcohol compounds: pentadecyl alcohol, hexadecyl alcohol, n-hexanol; Organic acid compounds: lauric acid, oleic acid; Polymers: PEG with molecular weights of 1500 and 2000 respectively.

4. The intelligent controllable intragastric weight loss balloon system according to claim 2, characterized in that: A heat conductor is embedded in the channel at the downstream end of the blockage body, and a heat insulator is embedded in the channel at the upstream end of the blockage body; the material of the heat conductor is selected from thermal grease and thermal adhesive, and the material of the heat insulator is selected from plastic, rubber and sponge.

5. The intelligent controllable intragastric weight loss balloon system according to claim 2, characterized in that: The plug is installed on the surface of the balloon or in a channel outside the balloon.

6. The intelligent controllable intragastric weight loss balloon system according to claim 1, characterized in that: The material of the blockage body also includes a magnetic sensitive material. The melting point of the non-degradable material is 58℃-350℃. The magnetic sensitive material converts electromagnetic energy into heat energy in an alternating magnetic field, causing the local temperature of the blockage body to rise to the phase transition critical point of the non-degradable material. Preferably, the melting point of the non-degradable material is 59℃-150℃. More preferably, the melting point of the non-degradable material is 60℃-95℃.

7. The intelligent controllable intragastric weight loss balloon system according to claim 6, characterized in that: The non-degradable material is selected from at least one of the following: Organic hydrocarbon compounds: paraffin, n-tetracosane, n-hexadecane, n-triane, naphthalene, anthracene, phenanthrene; Modified hydrocarbon compounds: oxidized polyethylene wax; Organic acid compounds: stearic acid, triacontaminant, benzoic acid, terephthalic acid, phthalic acid, gallic acid; Glyceryl ester: 1,3-dilaurate glyceryl ester; Organic alcohol compounds: pentadecyl alcohol, hexadecyl alcohol, n-hexanol, octadecanol, pentaerythritol, sorbitol, xylitol; Organic aldehydes: glucose; Amide compounds: urea; High molecular weight polymers: PE, PP, PVC, PS, PC, PA, PBT, PTFE, PEEK, PI, PHA, PU, ​​PET, ABS, PEG (molecular weight 2000-20000), and modified high molecular weight polymers; The magnetic sensitive material is selected from at least one of the following: Magnetic materials: manganese-zinc ferrite, nickel-zinc ferrite; pure iron, nickel, neodymium iron boron; iron(II,III) oxide, gamma iron(II,III) oxide; Non-magnetic materials: graphite, carbon fiber composite materials; Preferably, the magnetic material is iron(III) oxide or gamma-iron(III) oxide; preferably, the non-magnetic material is graphite.

8. The intelligent controllable intragastric weight loss balloon system according to claim 6, characterized in that: The channel is equipped with heat insulation materials at the upstream and downstream ends of the magnetically sensitive blocking body. The heat insulation materials are selected from plastic, rubber, and sponge.

9. The intelligent controllable intragastric weight loss balloon system according to claim 6, characterized in that: The channel extends into the balloon, and the plug is installed inside the channel within the balloon.

10. The intelligent controllable intragastric weight loss balloon system according to claim 1, characterized in that: The channel is provided with a drainage tube extending into the balloon at the upstream end of the blockage body, and drainage holes are evenly distributed on the side wall of the drainage tube.

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