Self-generating stomach residence electronic capsule and application thereof

Through the combination of self-generated gastric retention units and electrolyte propellants, the precise drug release and stable retention of gastric retention electronic capsules are achieved, solving the problems of uncontrollable drug release and external power supply risks in the prior art, and improving the safety and accuracy of drug delivery.

CN120267955AActive Publication Date: 2025-07-08ZHEJIANG UNIV

Patent Information

Application Number
CN202510750233.1
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-06-06
Publication Date
2025-07-08
Estimated Expiration
2045-06-06

AI Technical Summary

Technical Problem

The drug release process of existing gastric residency electronic capsules is uncontrollable, it is difficult to achieve accurate timing control, lacks on-demand drug release function, and external power supply systems increase system volume and circuit safety risks.

Method used

The self-generating gastric retention unit is adopted to generate electricity by using the anode and cathode to react primary battery reaction in the gastric juice. Combined with the electrochemical dissolution mechanism of electrolyte and propellant, the timed and quantitative release of drugs is achieved through the circuit system, and the stable retention and controllable separation of the capsule are ensured through the pH-responsive adhesive.

Benefits of technology

It realizes the accurate and controllable release of drugs, extends the working cycle, ensures stable stomach residency and avoids the risk of uncontrollable retention, reduces circuit safety risks, and improves the accuracy and safety of drug delivery.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention discloses a self-power-generation stomach residence electronic capsule and application thereof, and belongs to the technical field of medical capsules, the self-power-generation stomach residence electronic capsule structurally comprises a capsule shell, and a self-power-generation stomach residence unit, a drug release unit and a circuit system which are arranged in the capsule shell; the self-generating stomach residence unit structure comprises an anode, a plurality of elastic support arms, a cathode and a fastener, and the fastener fixes the plurality of elastic support arms between the anode and the cathode; the anode and the cathode are subjected to primary battery reaction in a gastric juice environment to generate power; the drug release unit is detachably connected with the self-generating gastric residence unit, the drug release unit comprises a drug cabin and a propelling module, the propelling module comprises an electrolyte, an isolating membrane and a propellant, the isolating membrane plays a role in isolating the electrolyte and the propellant and can be dissolved by the electrolyte under the condition that voltage is applied, and the drug cabin is connected with the drug cabin. After the electrolyte is in contact with the propellant, pushing force is generated to release the medicine in the medicine cabin.
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Description

Technical Field

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

[0002] Traditional drug delivery methods face severe challenges in medical emergencies due to complex operations and delayed responses. Medical electronic capsules, as swallowable micro-diagnostic and therapeutic devices, provide innovative solutions: their non-invasive characteristics not only revolutionize the diagnosis of gastrointestinal diseases (such as capsule endoscopy), but also achieve precise and rapid intervention in acute scenarios through targeted drug delivery and real-time physiological monitoring functions.

[0003] Medical electronic capsules can achieve non-invasive diagnosis and precise treatment, and are an important innovation direction in current medical research. On the one hand, the development of medical electronic capsules can revolutionize the diagnosis of gastrointestinal diseases and achieve targeted drug delivery and monitoring. On the other hand, they can also 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 medical costs and improving patients' quality of life.

[0004] The gastric resident electronic capsule can stay in the stomach for several days to several weeks or even longer, and it can continuously release drug ingredients to achieve therapeutic effects during the period of residence in the stomach. The capsule shell can generally be decomposed in the gastric acid environment, and the contents of the capsule stay in the stomach to play a therapeutic role, reduce the frequency of drug administration, improve patient compliance, and realize remote control drug release and health management functions. The gastric resident electronic capsule is not only an upgrade of the drug delivery system, but also has the potential to build an intelligent medical platform that connects diagnosis, treatment and prevention.

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

[0006] A Chinese patent document with the publication number CN113397486A discloses a health management system for ruminants, which includes 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 the physiological parameters of the ruminant. The communication unit transmits the collected physiological parameters to the storage unit, and the storage unit stores the physiological parameters. Thereby, the breeder can timely control the health status of the livestock, manage the diseased livestock in a timely manner, and avoid economic losses.

[0007] The existing gastric retention electronic capsules have the following technical defects: (1) The drug release process is uncontrollable, mainly relying on the passive diffusion mechanism, and the release rate is significantly affected by factors such as the pH value of the gastric environment and the peristalsis intensity, making it difficult to achieve precise sequential controlled release; (2) Lack of on-demand drug release function, unable to actively regulate according to individual patient differences or treatment needs, especially poor applicability for drug treatment regimens that require multiple-dose or responsive drug administration; (3) Most of the existing electronically controlled drug release devices use complex external power supply systems, which not only increase the system volume and affect oral comfort, but also pose circuit safety risks and are difficult to meet the requirements of clinical applications. Summary of the Invention

[0008] In order to solve the above-mentioned deficiencies in the existing technology, the present invention provides a self-powered gastric retention electronic capsule.

[0009] The specific technical solutions adopted are as follows: A self-powered gastric retention electronic capsule, comprising a capsule shell and a self-powered gastric retention unit, a drug release unit, and a circuit system inside it; The self-powered gastric retention unit includes a folded structure and an unfolded structure, which completes the transformation from the folded structure to the unfolded structure in the gastric juice environment. The structure of the self-powered gastric retention unit includes an anode, a plurality of elastic support arms, a cathode, and a fastener. The fastener fixes the plurality of 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 a primary battery reaction to generate electricity in the gastric juice environment; The drug release unit is detachably connected to the self-powered gastric retention unit. The drug release unit includes at least one medicine cabin and at least one propulsion module. The propulsion module includes an electrolyte, a separator membrane, and a propellant. The separator membrane isolates the electrolyte and the propellant, and the separator membrane can be dissolved by the electrolyte under the application of voltage. After the electrolyte contacts the propellant, a driving force is generated to realize the release of the drug in the medicine cabin; The circuit system includes an energy harvesting circuit, an energy storage module, a main control module, and electrodes. The energy harvesting circuit collects the electrical energy generated by the self-powered gastric retention unit and supplies the electrical energy to the energy storage module. The energy storage module supplies the electrical energy required for drug release of the drug release unit through the electrodes under the control of the main control module. The main control module communicates with the outside, obtains data or instructions, and sends the status of the electronic capsule.

[0010] Preferably, the elastic support arm is a shape 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 an elastic force to complete the transformation from the folded structure to the unfolded structure.

[0011] More preferably, the shape memory alloy can be a nickel-titanium alloy, and the polymer material can be an elastic polyurethane, etc.

[0012] More preferably, the material of the protective layer is polyurethane, polydimethylsiloxane, silica gel, polyvinyl alcohol, etc., and can be prepared in the form of a hydrogel to prevent the shape memory alloy, etc. from scratching the gastric mucosa.

[0013] Preferably, the number of elastic support arms is ≥3. In the unfolded structure of the self-powered gastric retention unit, the elastic support arms extend radially outward.

[0014] Preferably, the fastener is a nail-shaped structure (screws or rivets made of insulating materials such as nylon and polyetheretherketone can be selected), and the fastener penetrates through the anode, multiple elastic support arms, and the cathode to play a fixing role.

[0015] Preferably, the components in the self-powered gastric retention unit are bonded by an adhesive. The composition of 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 to the second component is 4-10:1.

[0016] When the pH of the environment where the self-powered gastric retention unit is located is acidic, the adhesive has strong adhesion, and the elastic support arms have sufficient strength to support the self-powered gastric retention unit to stay and not be discharged by the pylorus. When the pH of the environment where the self-powered gastric retention unit is located is weakly acidic or alkaline, the adhesion of the adhesive becomes weak, and the self-powered gastric retention unit is easily disassembled and discharged from the body. By controlling the environmental pH value, the controllable separation of the self-powered gastric retention electronic capsule can be achieved.

[0017] 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.

[0018] 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.

[0019] Preferably, the anode is a zinc sheet or a magnesium sheet, and the cathode is a copper sheet.

[0020] Optionally, the content drugs in each medicine cabin of the drug release unit are the same or different. Each medicine cabin is equipped with a propulsion module. Through the control of the circuit system, it can realize the fractional administration of the content drugs in different medicine cabins or the drug administration in response to physiological signals.

[0021] Preferably, the electrolyte is an aqueous solution containing chloride ions, the isolation membrane is a gold nanomembrane, and the propellant generates gas to push the release of the drug in the medicine cabin after contacting the electrolyte. The propellant is preferably a mixed powder column of citric acid (C6H8O7) and sodium bicarbonate (NaHCO3).

[0022] Preferably, the energy harvesting circuit includes a boost voltage regulator. The energy harvesting circuit optimizes the power of the electric energy collected by the self-powered gastric retention unit and provides it to the energy storage module; the energy storage module includes a capacitor or a rechargeable battery.

[0023] The present invention also provides a health management product, including the self-powered gastric retention electronic capsule described above.

[0024] Compared with the prior art, the beneficial effects of the present invention are as follows: 1. The self-powered gastric retention electronic capsule of the present invention can achieve non-invasive and ultra-long-term safe gastric retention. The deployment structure of the elastic stent arm with a yield stress ≥ 500 MPa (especially the superelastic memory nickel-titanium alloy stent arm) is used to ensure stable retention, realizing longer-term, safer and more stable gastric retention than the prior art, solving the problem of implantation. At the same time, it directly supplies power by the galvanic cell reaction between the anode and the cathode in gastric juice, without an external battery or frequent power source replacement.

[0025] 2. The self-powered gastric retention electronic capsule of the present invention can extend the working cycle - the galvanic cell reaction continuously supplies power, combined with a low-power circuit system, ensuring that the electronic capsule operates in the gastric acid environment for a long time, and can be used for multiple drug administrations and real-time monitoring.

[0026] 3. The self-powered gastric retention electronic capsule of the present invention can achieve safe and reliable on-demand drug release. It uses a voltage-triggered isolation membrane dissolution mechanism for drug release, precisely controls the reaction between the electrolyte and the propellant, realizes the timed and quantitative rapid release of drugs, and avoids the uncontrollability of traditional mechanical or osmotic pressure-driven methods.

[0027] 4. The self-powered gastric retention electronic capsule of the present invention can achieve precise and controllable separation. Through the synergistic effect of the pH-responsive adhesive and the elastic support arm, it ensures that the stent remains stable in the gastric acid environment and quickly disintegrates and is discharged in the alkaline intestinal environment, avoiding the risk of uncontrollable retention of traditional stents. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 FIGURES are the physical diagrams of the self-powered gastric retention electronic capsule in the compressed state and the deployed state.

[0029] Figure 2 FIGURES are the schematic structural diagrams of the self-powered gastric retention unit, the drug release unit, and the circuit system in the self-powered gastric retention electronic capsule.

[0030] Figure 3 FIGURES are the statistical charts of the charging rate of the lithium battery powered by the Zn / Cu electrode pair and the Mg / Cu electrode pair using gastric acid.

[0031] Figure 4 FIGURES are the sectional views of the structure of the drug release unit.

[0032] Figure 5 FIGURES are the diagrams of the electrochemical dissolution process of the gold nanomembrane at different times.

[0033] Figure 6 FIGURES are the drug release rate diagrams of the drug release unit.

[0034] Figure 7 FIGURES are the schematic diagrams of the chemical composition of the pH-responsive composite adhesive.

[0035] Figure 8 FIGURES are the statistical charts of the mechanical test results of the 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 the copolymer of methyl methacrylate-butyl methacrylate.

[0036] Figure 9 FIGURES are the statistical charts of the mechanical test results of the 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 the copolymer of methyl methacrylate-butyl methacrylate.

[0037] Figure 10 FIGURES are the schematic diagrams of simulating the controllable disintegration of the self-powered gastric retention unit.

[0038] Figure 11 FIGURES are the plasma drug concentration diagrams of lamotrigine.

[0039] Figure 12 FIGURES are the heart rate monitoring results. When the heart rate exceeds 200 rpm, the drug delivery capsule can be triggered to release the drug.

[0040] Figure 13 It is the monitoring result of the acceleration sensor, where X, Y, and Z represent the three axes of the acceleration sensor. Specific embodiments

[0041] To make the objectives, features, and advantages of the present invention more apparent and understandable, the following provides a detailed description through specific embodiments. Many specific details are set forth in the following description in order to fully understand the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present invention. Therefore, the present invention is not limited by the specific embodiments disclosed below. The technical features in various embodiments of the present invention can be combined correspondingly without conflict.

[0042] For the operating methods of the following embodiments without specifying specific conditions, they are generally in accordance with conventional conditions or those recommended by the manufacturer. The content not described in detail in this specification belongs to the prior art well-known to those skilled in the art. The experimental materials used in the following embodiments can be obtained from conventional biochemical reagent companies without special instructions.

[0043] Example 1 As Figure 1 shown, this embodiment provides a self-powered gastric-retention electronic capsule, which includes a capsule shell (size 9×27 mm) and its internal self-powered gastric-retention unit (in a compressed state), drug release unit, and circuit system. The structural schematic diagrams of the self-powered gastric-retention unit, drug release unit, and circuit system in the self-powered gastric-retention electronic capsule are as Figure 2 shown.

[0044] The self-powered gastric-retention unit includes a folded structure and an unfolded structure, and it completes the transformation from the folded structure to the unfolded structure in the gastric juice environment; the structure of the self-powered gastric-retention unit includes an anode, 3 elastic support arms, a cathode, and a fastener. 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-powered gastric-retention unit, the 3 elastic support arms extend radially outward; an insulating gasket is provided between the anode and the elastic support arms; the anode and the cathode undergo a galvanic cell reaction to generate electricity in the gastric juice environment.

[0045] Specifically, a zinc sheet is selected as the anode, a copper sheet as the cathode, and the elastic support arm is a superelastic nickel-titanium alloy (NiTi) with a polyurethane protective layer (yield stress ≥ 500 MPa, providing elastic force to complete the transformation from the folded structure to the unfolded structure). In the freely unfolded state, the radial structure formed by the elastic support arm can reach a diameter of 50 mm, significantly exceeding the diameter of the human pylorus (about 1 - 2 cm), thus effectively realizing the function of gastric retention; when the capsule shell dissolves in the stomach, the elastic support arm restores the unfolded structure by virtue of its superelasticity and resists gastric peristalsis through mechanical interaction with the gastric wall (anti-peristaltic force > 1.5 N), ensuring long-term retention in the stomach.

[0046] The principle of power generation of the self-powered gastric retention unit is as follows: Gastric acid, as a natural electrolyte, activates the oxidation reaction of the anode (Zn → Zn 2+ + 2e - ), and the reduction reaction of the cathode (such as 2H + + 2e - → H2↑), continuously generating electrical energy. Figure 3 The results of charging a rechargeable lithium battery with Zn / Cu and Mg / Cu electrode pairs in simulated gastric juice are shown. The results show that the charging speed of the Mg / Cu electrode pair is much faster than that of the Zn / Cu electrode pair.

[0047] The drug release unit is detachably connected to the self-powered gastric retention unit. The drug release unit includes four medicine cabins and four propulsion modules. The propulsion module and the medicine cabin are connected by a piston. Each medicine cabin is equipped with a corresponding propulsion module. The propulsion module includes electrolyte solution, a separator membrane, and a propellant. The separator membrane isolates the electrolyte solution and the propellant, and the separator membrane can be dissolved by the electrolyte solution under the application of voltage. When the electrolyte solution contacts the propellant, a driving force is generated to realize the release of the drug in the medicine cabin (the other end of the medicine cabin is a plug, which can fall off under the action of the driving force). The structural cross-sectional view of the drug release unit is as shown in Figure 4 shown.

[0048] Specifically, a gold nanomembrane with a thickness of 300 nm is used as the separator membrane, and the electrolyte solution is an aqueous hydrochloric acid solution. Among them, Cl - is a necessary reactant for the electrochemical dissolution of the gold nanomembrane. The gold nanomembrane can undergo electrochemical dissolution under the action of a 3V DC voltage. Its dissolution reaction follows the anodic Au + 4Cl - → AuCl4 - + 3e - , E 0 = 1.04 V. Therefore, it can be quickly dissolved in the electrolyte solution containing chloride ions ( Figure 5). The propellant is composed of citric acid and sodium bicarbonate powder mixed in a stoichiometric ratio. When the two come into contact 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 to achieve 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.

[0049] The circuit system includes an energy collection circuit, an energy storage module, a main control module and electrodes. The energy collection circuit collects the electric energy generated by the self-generating gastric retention unit and provides the electric energy to the energy storage module. Under the control of the main control module, the energy storage module provides the electric energy required for the drug release unit to release the drug through the electrode. The main control module communicates with the outside to obtain data instructions and send 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 electric energy required for the drug release unit to release the drug. After applying voltage 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.

[0050] The circuit system adopts flexible circuit manufacturing technology and is a PI circuit with a thickness of about 0.12mm. The energy collection circuit is mainly based on ultra-low power boost and voltage regulator chips, the energy storage module is a rechargeable battery or supercapacitor, and the main control module is a single-chip microcomputer with a Bluetooth module, which receives external or local sensor data and decides whether to increase the electrode voltage to start drug release after closed-loop algorithm analysis.

[0051] Example 2 Furthermore, an adhesive is used to bond the components in the self-generating gastric retention unit to give 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 to the second component is 4-10:1.

[0052] Specifically, the pH sensitive substance is Eudragit L100 or Eudragit S100, and the plasticizer is methyl methacrylate-butyl methacrylate copolymer.

[0053] For the controllable separation mechanism, the present invention adopts a pH-responsive composite adhesive module, which is composed of a pH-sensitive substance (Eudragit L100 or Eudragit S100) and a plasticizer (methyl methacrylate-butyl methacrylate copolymer) ( Figure 7 ). The addition of the plasticizer significantly improves the flexibility and adhesion strength of the adhesive, ensuring the stable fixation of the gastric retention system. By orally administering alkaline substances such as sodium carbonate to neutralize gastric acid (pH rises to 6-8), the dissolution of the adhesive can be precisely triggered, thereby realizing the controllable degradation and separation of the gastric retention system.

[0054] By adjusting the mass ratio of the pH-sensitive substance to the plasticizer (10:0, 9:1, 8:2), the mechanical properties of the adhesive were tested, and the results are as Figure 8 、 Figure 9 shown. The experiments show that when the mass ratio is 9:1, the adhesive exhibits the optimal adhesion force, which can not only resist the mechanical force generated by gastric peristalsis (>1.5 N), but also rapidly degrade after pH triggering.

[0055] As Figure 10 shown, the gastric retention system fixed with the pH-sensitive adhesive was placed in simulated gastric juice (pH 1.2), and the gastric peristalsis impact was simulated by a mechanical small block. Subsequently, sodium bicarbonate was added to neutralize the pH value to the target range, and the system was completely degraded within 180 minutes, verifying the reliability of its separation on demand.

[0056] Example 3 Remotely triggered active drug delivery mode: This mode uses a smartphone to remotely activate the drug injection function with one key, which is suitable for scenarios where patients can cooperate autonomously. This self-powered gastric retention electronic capsule is internally equipped with lamotrigine as a model drug for simulating the treatment of epileptic seizures. The self-powered gastric retention electronic capsule was orally administered to healthy and active beagle dogs, and the drug release was randomly triggered during their daily activities. Through pharmacokinetic analysis, the plasma drug concentration reached the therapeutic level within 30 minutes after triggering ( Figure 11 ), verifying the reliability of the rapid response.

[0057] Closed-loop automatic drug delivery mode based on external sensors: This mode uses a wearable device to continuously monitor vital signs (such as heart rate and blood oxygen saturation) and automatically trigger drug release in case of emergency. This self-powered gastric retention electronic capsule is further integrated with infrared / red light LEDs and photodetectors, paired with an NRF52840 microcontroller, to continuously collect heart rate and blood oxygen data and transmit them to a smartphone for analysis via Bluetooth. It is set to trigger the capsule to release metoprolol for intervention when the heart rate exceeds 200 bpm for 5 seconds. As Figure 12 can be seen, the heart rate began to decline 15 minutes after the drug release, and the vital signs returned to normal within 30 minutes.

[0058] Autonomous decision-making drug delivery mode integrated with sensors: In this mode, motion sensors (such as accelerometers) are directly integrated inside the self-powered gastric retention electronic capsule, without relying on external devices, and are suitable for extreme environments or scenarios with limited wireless communication. The motion state of beagle dogs (rest, normal activity, manic episode) is monitored through the accelerometer, and the standard deviation (STD) of a 10-second window is calculated as an index of motion intensity. When the STD exceeds 0.5g for 5 minutes, it is determined as a manic episode and drug release is triggered. Drug administration is completed within 5 minutes after the symptom appears, and the symptom improves within 1 hour ( Figure 13 ).

[0059] The reliability of the present invention has been verified in the above three modes, which can meet the rapid and accurate drug delivery needs of different acute medical scenarios.

[0060] The above-described embodiments have elaborated on 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 used to limit the present invention. Any modifications, supplements, or substitutions in a similar manner within the scope of the principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A self-powered gastric retention electronic capsule, characterized in that, It includes a capsule shell and an internally self-powered gastric retention unit, a drug release unit, and a circuit system therein; The self-powered gastric retention unit includes a folded structure and an unfolded structure, and it completes the transformation from the folded structure to the unfolded structure in the gastric juice environment; the structure of the self-powered gastric retention unit includes an anode, a plurality of elastic support arms, a cathode, and a fastener, and the fastener fixes the plurality of 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 undergo a galvanic cell reaction to generate electricity in the gastric juice environment; The drug release unit is detachably connected to the self-powered gastric retention unit. The drug release unit includes at least one medicine cabin and at least one propulsion module. The propulsion module includes an electrolyte, a separator membrane, and a propellant. The separator membrane isolates the electrolyte and the propellant, and the separator membrane 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 drug in the medicine cabin; The circuit system includes an energy harvesting circuit, an energy storage module, a main control module, and electrodes. The energy harvesting circuit harvests the electrical energy generated by the self-powered gastric retention unit and supplies the electrical energy to the energy storage module; The energy storage module supplies 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, obtains data or instructions and sends the status of the electronic capsule.

2. The self-powered gastric-retention electronic capsule according to claim 1, wherein The elastic support arms are shape memory alloys with protective layers or polymer materials with protective layers. The yield stress of the elastic support arms ≥500 MPa, and the elastic support arms provide elastic force to complete the transformation from the folded structure to the unfolded structure.

3. The self-powered gastric-retention electronic capsule according to claim 1, wherein The number of elastic support arms ≥3. In the unfolded structure of the self-powered gastric retention unit, the elastic support arms extend radially outward.

4. The self-powered gastric-retention electronic capsule according to claim 1, wherein The fastener is a nail-like structure, and the fastener penetrates through the anode, the plurality of elastic support arms, and the cathode to play a fixing role.

5. The self-powered gastric-retention electronic capsule according to claim 1, characterized in that, The components in the self-powered gastric retention unit are bonded using an adhesive. The composition of 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 to the second component is 4-10:

1.

6. The self-powered gastric retention electronic capsule according to claim 1, wherein 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.

7. The self-powered gastric-retention electronic capsule according to claim 1, wherein One medicine cabin is equipped with one propulsion module. Through the control of the circuit system, sequential administration of the drugs in different medicine cabins can be achieved.

8. The self-powered gastric-retention electronic capsule according to claim 1, wherein The electrolyte selected is an aqueous solution containing chloride ions, the separator membrane selected is a gold nanomembrane, and the propellant generates gas after contacting the electrolyte to push the release of the drug in the medicine cabin.

9. The self-powered gastric retention electronic capsule according to claim 1, characterized in that The energy harvesting circuit includes a boost voltage regulator. The energy harvesting circuit optimizes the power of the electrical energy generated by the self-powered gastric retention unit collected and supplies it to the energy storage module; the energy storage module includes a capacitor or a rechargeable battery.

10. A health management product, characterized in that, It includes the self-powered gastric retention electronic capsule according to any one of claims 1-9.

Citation Information

Patent Citations

  • Ruminant health management system and management method

    CN113397486A

  • Electronic capsule, in-vitro controller and noninvasive detection system

    CN221963586U

  • Materials architecture for gastric residence systems

    CN109310639A

  • A capsule and a system thereof

    CN110573062A

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    CN114945355A

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