A self-generating gastric-resident electronic capsule and its application

Abstract

The present invention discloses a self-generating gastric resident electronic capsule and its application, belonging to the technical field of medical capsules. The structure includes a capsule shell and a self-generating gastric resident unit, a drug release unit and a circuit system inside the capsule. The self-generating gastric resident unit structure includes an anode, multiple elastic support arms, a cathode and a fastener, and the multiple elastic support arms are fixed between the anode and the cathode by the fastener. The anode and the cathode generate electricity by a primary battery reaction in a gastric fluid environment. The drug release unit is detachably connected to the self-generating gastric resident unit. The drug release unit includes a medicine cabin and a propulsion module. The propulsion module includes an electrolyte, an isolation membrane and a propellant. The isolation membrane isolates the electrolyte and the propellant and can be dissolved by the electrolyte when a voltage is applied. After the electrolyte contacts the propellant, a driving force is generated to realize the release of the medicine in the medicine cabin.

Description

Technical Field

[0001] The present invention relates to the technical field of medical capsules, and in particular to a self-generating gastric-resident electronic capsule and applications thereof. Background Art

[0002] Traditional drug delivery methods face significant challenges during medical emergencies due to complex procedures and delayed responses. Medical electronic capsules, as swallowable miniature diagnostic and therapeutic devices, offer an innovative solution. Their non-invasive nature not only revolutionizes the diagnosis of gastrointestinal diseases (e.g., capsule endoscopy), but also enables precise and rapid intervention in acute situations through targeted drug delivery and real-time physiological monitoring.

[0003] Medical electronic capsules, enabling noninvasive diagnosis and precise treatment, are a key innovation in current medical research. On one hand, their development could revolutionize the diagnosis of gastrointestinal diseases, enabling targeted drug delivery and monitoring. Furthermore, they could integrate biosensors to monitor physiological signals and promote the development of personalized medicine. Electronic capsules are also expected to become a core tool for chronic disease management, significantly reducing healthcare costs and improving patients' quality of life.

[0004] Gastric-resident electronic capsules can remain in the stomach for days, weeks, or even longer, continuously releasing their drug components to achieve therapeutic effects. The capsule shell typically disintegrates in the acidic environment of the stomach, allowing the capsule contents to remain in the stomach and exert their therapeutic effects. This reduces dosing frequency, improves patient compliance, and enables remote drug release and health management. Gastric-resident electronic capsules are not only an upgrade to drug delivery systems but also hold the potential to build an intelligent medical platform connecting diagnosis, treatment, and prevention.

[0005] Chinese patent document CN221963586U discloses an electronic capsule, which includes: a shell, which has a shape similar to a medicine capsule so that it can be swallowed from the mouth into the abdomen; sensors, including a pressure sensor, for obtaining pressure; a storage unit; a transmission unit; a controller for collecting data from the sensors and controlling the transmission unit to transmit the data; and a battery for providing power to the transmission unit, sensors, storage unit, and controller. The electronic capsule can obtain a variety of human physiological data, such as intra-abdominal pressure (IAP), temperature, gastrointestinal surface conditions, etc., for use in assessing the health of multiple human systems and organs.

[0006] Chinese patent publication CN113397486A discloses a ruminant health management system comprising a capsule collection unit, a communication unit, a storage unit, a judgment unit, and a push unit. The capsule collection unit is placed in the rumen of the ruminant to collect physiological parameters. The communication unit transmits the collected physiological parameters to the storage unit, which then stores the parameters. This allows farmers to monitor the health of their livestock and manage any sick animals promptly, thus avoiding economic losses.

[0007] Existing gastric-resident electronic capsules have the following technical defects: (1) The drug release process is uncontrollable and mainly relies on the passive diffusion mechanism. The release rate is significantly affected by factors such as the pH value of the gastric environment and the peristaltic intensity, making it difficult to achieve precise time-controlled release; (2) There is a lack of on-demand drug release function, and it is impossible to actively regulate according to individual patient differences or treatment needs, especially for drug treatment plans that require fractionated or responsive administration; (3) Existing electrically controlled drug release devices mostly use complex external power supply systems, which not only increase the system volume and affect oral comfort, but also pose circuit safety risks, making it difficult to meet clinical application requirements. Summary of the Invention

[0008] In order to solve the above-mentioned deficiencies in the prior art, the present invention provides a self-generating gastric-resident electronic capsule.

[0009] The specific technical solutions adopted are as follows:

[0010] A self-generating gastric resident electronic capsule, comprising a capsule shell and a self-generating gastric resident unit, a drug releasing unit and a circuit system inside the capsule;

[0011] The self-generating gastric resident unit includes a folded structure and an unfolded structure, and completes the transition from the folded structure to the unfolded structure in a gastric fluid environment. The self-generating gastric resident unit structure includes an anode, multiple elastic support arms, a cathode, and a fastener, wherein the fastener fixes the multiple elastic support arms between the anode and the cathode; an insulating layer is provided between the anode and the elastic support arms, and / or an insulating layer is provided between the cathode and the elastic support arms; the anode and the cathode generate electricity through a galvanic cell reaction in the gastric fluid environment;

[0012] The drug release unit is detachably connected to the self-generating gastric retention unit. The drug release unit includes at least one drug capsule and at least one propulsion module. The propulsion module includes an electrolyte, an isolation membrane, and a propellant. The isolation membrane isolates the electrolyte and the propellant, and the isolation membrane can be dissolved by the electrolyte when a voltage is applied. When the electrolyte contacts the propellant, a driving force is generated to release the drug in the drug capsule.

[0013] The circuit system includes an energy collection circuit, an energy storage module, a main control module and electrodes. The energy collection circuit collects the electrical energy generated by the self-generating gastric resident unit and provides the electrical energy to the energy storage module; the energy storage module provides the electrical energy required for the drug release unit to release the drug through the electrodes under the control of the main control module; the main control module communicates with the outside world, obtains data or instructions and sends the status of the electronic capsule.

[0014] Preferably, the elastic support arm is a memory alloy with a protective layer or a polymer material with a protective layer, the yield stress of the elastic support arm is ≥500 MPa, and the elastic support arm provides elastic force to complete the transition from the folded structure to the unfolded structure.

[0015] More preferably, the memory alloy may be nickel-titanium alloy, and the polymer material may be elastic polyurethane or the like.

[0016] More preferably, the material of the protective layer is polyurethane, polydimethylsiloxane, silica gel, polyvinyl alcohol, etc., which can be prepared into a hydrogel to prevent the memory alloy from scratching the gastric mucosa.

[0017] Preferably, the number of the elastic support arms is ≥3, and in the expanded configuration of the self-generating gastric resident unit, the elastic support arms extend radially outward.

[0018] Preferably, the fastener is a nail-shaped structure (screws or rivets made of insulating materials such as nylon and polyetheretherketone can be used), and the fastener penetrates the anode, the multiple elastic support arms and the cathode to fix them.

[0019] Preferably, the components in the self-generating gastric retention unit are bonded with an adhesive, the adhesive consists of a first component and a second component, the first component is a pH sensitive substance, the second component is a plasticizer, and the mass ratio of the first component to the second component is 4-10:1.

[0020] When the pH of the environment surrounding the self-powered gastric resident unit is acidic, the adhesive has strong adhesion, and the elastic support arms are strong enough to support the self-powered gastric resident unit and prevent it from being expelled from the pylorus. When the pH of the environment surrounding the self-powered gastric resident unit is weakly acidic or alkaline, the adhesive's adhesion weakens, and the self-powered gastric resident unit is prone to disintegration and excretion. By controlling the environmental pH value, the self-powered gastric resident electronic capsule can be controlled to separate.

[0021] Specifically, the pH sensitive substance is Eudragit L100 or Eudragit S100, and the plasticizer is methyl methacrylate-butyl methacrylate copolymer, diethyl phthalate, polyethylene glycol 400 or triethyl citrate.

[0022] Specifically, the anode is zinc, magnesium or aluminum, and the cathode is copper, platinum, platinum carbon, palladium, gold, carbon nanotubes, magnesium oxide, lead oxide, nickel oxide, manganese dioxide, silver oxide, silver chloride or copper sulfide.

[0023] Preferably, the anode is a zinc sheet or a magnesium sheet, and the cathode is a copper sheet.

[0024] Optionally, the contents of each drug compartment in the drug release unit are the same or different, and one drug compartment is equipped with a propulsion module, which, through the control of the circuit system, can achieve fractionated administration of the contents of drugs in different drug compartments or administration in response to physiological signals.

[0025] Preferably, the electrolyte is an aqueous solution containing chloride ions, the isolation membrane is a gold nanomembrane, and the propellant generates gas after contacting the electrolyte to promote the release of the drug in the medicine capsule. The propellant is preferably a mixed powder column of citric acid (C6H8O7) and sodium bicarbonate (NaHCO3).

[0026] Preferably, the energy collection circuit includes a boost regulator, and the energy collection circuit optimizes the power of the collected electric energy generated by the self-generating gastric resident unit and provides it to the energy storage module; the energy storage module includes a capacitor or a rechargeable battery.

[0027] The present invention also provides a health management product, including the self-generating gastric-resident electronic capsule.

[0028] Compared with the prior art, the present invention has the following beneficial effects:

[0029] 1. The self-generating gastric-residing electronic capsule of the present invention can achieve non-invasive, ultra-long-term safe gastric residence. The deployed structure of elastic stent arms (particularly superelastic memory nickel-titanium alloy stent arms) with a yield stress ≥ 500 MPa ensures stable residence, achieving longer-term, safer, and more stable gastric residence than existing technologies, solving the problem of implantation. At the same time, the galvanic cell reaction of the anode and cathode in gastric fluid is used to directly power the capsule, eliminating the need for external batteries or frequent power supply changes.

[0030] 2. The self-generating gastric-resident electronic capsule of the present invention can extend the working cycle - the primary battery reaction continuously supplies power, combined with a low-power circuit system, to ensure that the electronic capsule can operate for a long time in a gastric acid environment, and can be used for multiple drug administration and real-time monitoring.

[0031] 3. The self-generating gastric-resident electronic capsule of the present invention can achieve safe and reliable on-demand drug release. It uses a voltage-triggered isolation membrane dissolution mechanism to release drugs, accurately controls the reaction between electrolyte and propellant, and achieves timely and quantitative rapid release of drugs, avoiding the uncontrollability of traditional mechanical or osmotic pressure-driven methods.

[0032] 4. The self-generating gastric-resident electronic capsule of the present invention can achieve precise and controllable separation. Through the synergistic effect of the pH-responsive adhesive and the elastic stent arm, it ensures that the stent is stably retained in the gastric acid environment and quickly disintegrated and discharged in the alkaline environment of the intestine, avoiding the risk of uncontrollable retention of traditional stents. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 Actual pictures of the self-generating gastric-resident electronic capsule in compressed and expanded states.

[0034] Figure 2 This is a schematic diagram of the structure of the self-generating gastric resident unit, drug release unit and circuit system in the self-generating gastric resident electronic capsule.

[0035] Figure 3 This is a statistical chart of the charging rate of lithium batteries generated by Zn / Cu electrode pairs and Mg / Cu electrode pairs using gastric acid to generate electricity.

[0036] Figure 4 This is a cross-sectional view of the structure of the drug release unit.

[0037] Figure 5 Diagram of the electrochemical dissolution process of gold nanofilm at different times.

[0038] Figure 6 is the drug release rate graph of the drug release unit.

[0039] Figure 7 Schematic diagram of the chemical composition of pH-responsive composite adhesive.

[0040] Figure 8 This is a statistical chart of the mechanical test results of Eudragit L100 composite adhesive immersed in different pH solutions for 3 hours and 7 days, where a:c represents the mass ratio of Eudragit L100 to methyl methacrylate-butyl methacrylate copolymer.

[0041] Figure 9 This is a statistical chart of the mechanical test results of Eudragit S100 composite adhesive immersed in different pH solutions for 3 hours and 7 days, where b:c represents the mass ratio of Eudragit S100 to methyl methacrylate-butyl methacrylate copolymer.

[0042] Figure 10 Schematic diagram simulating the controlled disintegration of a self-generating gastric resident unit.

[0043] Figure 11 Figure 4 is a graph of lamotrigine plasma drug concentration.

[0044] Figure 12 The heart rate monitoring result is that when the heart rate exceeds 200 rpm, the drug delivery capsule will be triggered to deliver the drug.

[0045] Figure 13 is the monitoring result of the acceleration sensor, where X, Y, and Z represent the three axes of the acceleration sensor. DETAILED DESCRIPTION

[0046] In order to make the objects, features and advantages of the present invention more clearly understood, a detailed description is given below using specific embodiments. In the following description, many specific details are set forth to fully understand the present invention. However, the present invention can be implemented in many other ways than those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below. The technical features in the various embodiments of the present invention can be combined accordingly without conflicting with each other.

[0047] The procedures for the following examples, in which specific conditions are not specified, generally follow conventional conditions or those recommended by the manufacturer. Any material not described in detail in this specification belongs to the prior art known to those skilled in the art. The experimental materials used in the following examples, unless otherwise specified, can be purchased from conventional biochemical reagent companies.

[0048] Example 1

[0049] like Figure 1 As shown, this embodiment provides a self-generating gastric resident electronic capsule, which includes a capsule shell (size 9×27 mm) and a self-generating gastric resident unit (compressed state), a drug release unit and a circuit system inside. The structural schematic diagram of the self-generating gastric resident unit, the drug release unit and the circuit system in the self-generating gastric resident electronic capsule is shown in FIG. Figure 2 shown.

[0050] The self-generating gastric resident unit includes a folding structure and an unfolding structure, which completes the transition from the folding structure to the unfolding structure in a gastric fluid environment; the self-generating gastric resident unit structure includes an anode, three elastic support arms, a cathode and a fastener, and the nail-shaped fastener penetrates and fixes the anode, multiple elastic support arms and the cathode, fixing the elastic support arms between the anode and the cathode. In the unfolded structure of the self-generating gastric resident unit, the three elastic support arms extend radially outward; an insulating gasket is provided between the anode and the elastic support arm; the anode and the cathode generate electricity through a galvanic cell reaction in the gastric fluid environment.

[0051] Specifically, the anode is a zinc sheet, the cathode is a copper sheet, and the elastic stent arms are made of a superelastic nickel-titanium alloy (NiTi, yield stress ≥500 MPa) with a polyurethane protective layer, providing the elastic force to complete the transition from the folded structure to the unfolded structure. In the freely unfolded state, the radial structure formed by the elastic stent arms can reach a diameter of 50 mm, significantly exceeding the diameter of the human pylorus (approximately 1-2 cm), effectively achieving gastric retention. Once the capsule shell enters the stomach and dissolves, the elastic stent arms utilize their superelasticity to restore the unfolded structure and mechanically interact with the stomach wall to resist gastric peristalsis (anti-peristalsis force >1.5 N), ensuring long-term retention in the stomach.

[0052] The principle of self-generated gastric resident unit power generation is: gastric acid as a natural electrolyte activates the oxidation reaction of the anode (Zn → Zn 2+ + 2e - ) and cathode reduction reactions (such as 2H + + 2e - → H2↑), continuously generating electrical energy. Figure 3 The results of charging rechargeable lithium batteries in simulated gastric fluid using Zn / Cu and Mg / Cu electrode pairs are presented. The results show that the charging speed of the Mg / Cu electrode pair is much faster than that of the Zn / Cu electrode pair.

[0053] The drug release unit is detachably connected to the self-generating gastric retention unit. The drug release unit includes four medicine chambers and four propulsion modules. The propulsion modules and the medicine chambers are connected by pistons. Each medicine chamber is equipped with a corresponding propulsion module. The propulsion module includes an electrolyte, an isolation membrane and a propellant. The isolation membrane isolates the electrolyte and the propellant, and the isolation membrane can be dissolved by the electrolyte when a voltage is applied. When the electrolyte contacts the propellant, a driving force is generated to release the drug in the medicine chamber (the other end of the medicine chamber is a plug that can fall off under the action of the driving force). The structural cross-section of the drug release unit is shown in the figure below. Figure 4 shown.

[0054] Specifically, a gold nanofilm with a thickness of 300 nm is used as the isolation membrane, and the electrolyte is a hydrochloric acid aqueous solution, wherein Cl - As a necessary reactant for the electrochemical dissolution of gold nanofilm, the gold nanofilm can undergo electrochemical dissolution under the action of 3V DC voltage, and its dissolution reaction follows the anode Au + 4Cl - → AuCl4 - + 3e - , E 0 = 1.04 V, so it can dissolve quickly in electrolytes containing chloride ions ( Figure 5The propellant is composed of citric acid and sodium bicarbonate powder mixed in a stoichiometric ratio. When the two react with water, a chemical reaction occurs: 3NaHCO3 + C6H8O7 → C6H6O7Na3 + 3H2O + 3CO2↑, which can produce a large amount of carbon dioxide gas. The whole process is as follows: When a 3V DC voltage is applied, the gold nanofilm is - Electrochemical dissolution occurs in the electrolyte, removing the isolation effect on the electrolyte and propellant; then the electrolyte contacts the propellant and triggers a chemical reaction, generating high-pressure gas to drive the piston movement, achieving rapid release of the drug. This design achieves remote triggering and timing control of drug release by precisely controlling the electrochemical dissolution process of the gold nanofilm. Figure 6 The results showed that the drug release unit could release the drug in about 30 s-40 s.

[0055] The circuit system includes an energy collection circuit, an energy storage module, a main control module and electrodes. The energy collection circuit collects the electrical energy generated by the self-generating gastric retention unit and provides the electrical energy to the energy storage module. Under the control of the main control module, the energy storage module provides the electrical energy required for the drug release unit to release the drug through the electrode. The main control module communicates with the outside, obtains data instructions and sends the status of the electronic capsule. The main control module controls the electrode voltage. The electrodes are divided into a first electrode and a second electrode (positive electrode and negative electrode). The first electrode is in contact with the isolation membrane and the electrolyte, and the second electrode is in contact with the electrolyte. The first electrode and the second electrode are physically isolated, and the first electrode, the second electrode and the isolation membrane form a loop. The first electrode and the second electrode provide the electrical energy required for the drug release unit to release the drug. After voltage is applied to the first electrode and the second electrode, the part of the isolation membrane in contact with the electrolyte is electrolyzed, and the electrolyte is mixed with the propellant to generate a large amount of gas, which pushes the piston, and the piston further pushes the drug out.

[0056] The circuit system utilizes a flexible circuit manufacturing process, resulting in a PI circuit approximately 0.12mm thick. The energy harvesting circuit primarily utilizes an ultra-low-power boost and voltage regulator chip, while the energy storage module utilizes a rechargeable battery or supercapacitor. The main control module is a single-chip microcomputer with a Bluetooth module. This receives data from external or local sensors and, after analyzing it using a closed-loop algorithm, determines whether to increase the electrode voltage to initiate drug release.

[0057] Example 2

[0058] Furthermore, an adhesive is used to bond the components in the self-generating gastric retention unit, giving the self-generating gastric retention unit a controllable separation effect. The adhesive consists of a first component and a second component. The first component is a pH-sensitive substance, and the second component is a plasticizer. The mass ratio of the first component and the second component is 4-10:1.

[0059] Specifically, the pH sensitive substance is Eudragit L100 or Eudragit S100, and the plasticizer is methyl methacrylate-butyl methacrylate copolymer.

[0060] For the controllable separation mechanism, the present invention adopts a pH-responsive composite adhesive module, which is composed of a pH-sensitive substance (Eudrat® L100 or Eudrat® S100) and a plasticizer (methyl methacrylate-butyl methacrylate copolymer). Figure 7 The addition of a plasticizer significantly enhances the adhesive's flexibility and adhesion strength, ensuring stable fixation of the gastric retention system. Oral administration of alkaline substances such as sodium carbonate neutralizes gastric acid (raising the pH to 6-8), precisely triggering the adhesive's dissolution and enabling controlled degradation and separation of the gastric retention system.

[0061] The mechanical properties of the adhesive were tested by adjusting the mass ratio of pH sensitive substance to plasticizer (10:0, 9:1, 8:2). Figure 8 、 Figure 9 As shown, experiments show that when the mass ratio is 9:1, the adhesive exhibits optimal adhesion, which can both resist the mechanical force generated by gastric peristalsis (>1.5 N) and degrade rapidly after pH triggering.

[0062] like Figure 10 As shown, the pH-sensitive adhesive-immobilized gastric retention system was placed in simulated gastric fluid (pH 1.2) and subjected to mechanical stimulation to simulate gastric peristalsis. Sodium bicarbonate was then added to neutralize the pH to the target range, and the system completely degraded within 180 minutes, demonstrating the reliability of its on-demand separation.

[0063] Example 3

[0064] Remotely triggered active drug delivery mode: This mode uses a smartphone to remotely activate the drug delivery function with one click, suitable for scenarios where patients can cooperate autonomously. This self-generating gastric resident electronic capsule contains lamotrigine as a model drug for the treatment of simulated epileptic seizures. The self-generating gastric resident electronic capsule was orally administered to healthy, active beagle dogs, and drug release was randomly triggered during their daily activities. Pharmacokinetic analysis showed that plasma drug concentrations reached therapeutic levels within 30 minutes after triggering ( Figure 11 ), confirming the reliability of the rapid response.

[0065] Closed-loop automatic drug delivery mode based on external sensors: This mode monitors vital signs (such as heart rate and blood oxygen saturation) in real time through wearable devices and automatically triggers drug release in emergency situations. The self-powered gastric-resident electronic capsule further integrates infrared / red LEDs and photodetectors, and is paired with an NRF52840 microcontroller to collect heart rate and blood oxygen data in real time and transmit them to a smartphone via Bluetooth for analysis. When the heart rate exceeds 200 bpm for 5 seconds, the capsule is triggered to release metoprolol for intervention. Figure 12 It can be seen that the heart rate began to decrease 15 minutes after the drug was released, and vital signs returned to normal within 30 minutes.

[0066] Autonomous drug delivery mode with integrated sensors: This mode integrates motion sensors (such as accelerometers) directly into the self-generating gastric resident electronic capsule, without relying on external devices. It is suitable for extreme environments or scenarios where wireless communication is limited. The accelerometer is used to monitor the beagle's movement status (resting, normal activity, manic episode), and the standard deviation (STD) of the 10-second window is calculated as an indicator of exercise intensity. When the STD exceeds 0.5g for 5 minutes, it is determined to be a manic episode and triggers drug release. The drug is administered within 5 minutes of the onset of symptoms, and the symptoms are improved within 1 hour ( Figure 13 ).

[0067] The above three modes all verify the reliability of the present invention and can meet the needs of rapid and accurate drug delivery in different acute medical scenarios.

[0068] The embodiments described above provide a detailed description of the technical solutions of the present invention. It should be understood that the above are only specific embodiments of the present invention and are not intended to limit the present invention. Any modifications, supplements or similar substitutions made within the scope of the principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A self-generating gastric resident electronic capsule, characterized in that: It includes a capsule shell and a self-generating gastric residence unit, a drug release unit and a circuit system inside the capsule; The self-generating gastric resident unit includes a folding structure and an unfolding structure, and completes the transformation from the folding structure to the unfolding structure in a gastric fluid environment; the self-generating gastric resident unit structure includes an anode, multiple elastic support arms, a cathode, and a fastener, and the fastener fixes the multiple elastic support arms between the anode and the cathode; an insulating layer is provided between the anode and the elastic support arms, and / or an insulating layer is provided between the cathode and the elastic support arms; the anode and the cathode generate electricity by a galvanic cell reaction in the gastric fluid environment; the components of the self-generating gastric resident unit are bonded by an adhesive, and the adhesive is composed of a first component and a second component, the first component is a pH-sensitive substance, the second component is a plasticizer, and the mass ratio of the first component to the second component is 4-10:1; The pH sensitive substance is Eudragit L100 or Eudragit S100, and the plasticizer is methyl methacrylate-butyl methacrylate copolymer, diethyl phthalate, polyethylene glycol 400 or triethyl citrate; The drug release unit is detachably connected to the self-generating gastric retention unit and includes at least one drug capsule and at least one propulsion module. The propulsion module includes an electrolyte, an isolation membrane, and a propellant. The isolation membrane isolates the electrolyte and the propellant and can be dissolved by the electrolyte when a voltage is applied. When the electrolyte and the propellant come into contact, a driving force is generated to release the drug from the drug capsule. The electrolyte is a hydrochloric acid aqueous solution, the isolation membrane is a 300nm thick gold nanofilm, and the propellant is a mixed powder column of citric acid (C6H8O7) and sodium bicarbonate (NaHCO3). The circuit system includes an energy collection circuit, an energy storage module, a main control module and electrodes. The energy collection circuit collects the electrical energy generated by the self-generating gastric resident unit and provides the electrical energy to the energy storage module. Under the control of the main control module, the energy storage module provides the electrical energy required for the drug release unit to release the drug through electrodes; the main control module communicates with the outside, obtains data or instructions and sends the status of the electronic capsule.

2. The self-generating gastric-resident electronic capsule according to claim 1, characterized in that: The elastic support arm is a memory alloy with a protective layer or a polymer material with a protective layer. The yield stress of the elastic support arm is ≥500 MPa. The elastic support arm provides elastic force to complete the transition from the folded structure to the unfolded structure.

3. The self-generating gastric-resident electronic capsule according to claim 1, characterized in that: The number of the elastic support arms is ≥3, and in the expanded configuration of the self-generating gastric resident unit, the elastic support arms extend radially outward.

4. The self-generating gastric resident electronic capsule according to claim 1, characterized in that: The fastener is a nail-shaped structure, and the fastener penetrates the anode, the multiple elastic support arms and the cathode to play a fixing role.

5. The self-generating gastric resident electronic capsule according to claim 1, characterized in that: The anode is zinc, magnesium or aluminum, and the cathode is copper, platinum, platinum carbon, palladium, gold, carbon nanotubes, magnesium oxide, lead oxide, nickel oxide, manganese dioxide, silver oxide, silver chloride or copper sulfide.

6. The self-generating gastric resident electronic capsule according to claim 1, characterized in that: A medicine chamber is equipped with a propulsion module, which can realize the fractionated administration of medicines in different medicine chambers through the control of the circuit system.

7. The self-generating gastric-resident electronic capsule according to claim 1, characterized in that: The energy collection circuit includes a boost regulator, which optimizes the power of the collected electric energy generated by the self-generating gastric resident unit and then provides it to the energy storage module; the energy storage module includes a capacitor or a rechargeable battery.

8. A health management product, characterized in that: The invention comprises the self-generating gastric-resident electronic capsule according to any one of claims 1 to 7.

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