Drug sustained release control system for intelligently monitoring vagina environment

Abstract

The invention discloses a drug sustained-release control system for intelligently monitoring a vagina environment, and the system comprises a data monitoring device which is disposed in a vagina region of a target user and is used for obtaining the sensing data of the vagina region; the data processing device is connected to the data monitoring device and used for determining a drug release instruction corresponding to the target user according to the sensing data; and the drug sustained release device stores treatment drugs, is arranged in the vagina area, is connected to the data processing device, and is used for releasing the treatment drugs to the vagina area according to the drug release instruction so as to treat the target user. Therefore, the vaginal environment of the user can be monitored accurately in real time based on the data monitoring device, accurate release of the medicine is controlled based on the monitoring result, vaginal bacteria of the user can be killed more timely and accurately, and more intelligent auxiliary service is provided for treatment of the user.

Description

Technical Field

[0001] The present invention relates to the technical field of drug sustained-release control, and in particular to a drug sustained-release control system for intelligently monitoring vaginal environment. Background Art

[0002] The health of the vaginal environment has an important impact on women's physical health. At present, with the development of medical technology, local vaginal drug administration has become an important means of treating gynecological diseases. Traditional vaginal drug administration methods mainly include suppositories, gels, etc. Although these drug administration methods are convenient to use, they have problems such as uneven drug administration, short duration of action, and the need for frequent drug administration, which seriously affects the treatment effect and patient compliance.

[0003] To solve the above problems, a variety of vaginal drug delivery devices have appeared on the market, but these devices still fail to meet clinical needs well. Most existing devices only use simple physical diffusion to release drugs, lacking precise control of the release process. These devices cannot monitor changes in the vaginal environment in real time. At the same time, due to the lack of data collection and transmission functions, doctors cannot understand the patient's medication status and treatment effects in real time, and it is difficult to adjust the treatment plan in time, which not only affects the evaluation and optimization of the treatment effect, but also increases the communication cost between doctors and patients. Therefore, the existing technology has defects and needs to be improved urgently. Summary of the invention

[0004] The technical problem to be solved by the present invention is to provide a drug sustained-release control system that intelligently monitors the vaginal environment, which can monitor the user's vaginal environment in real time and accurately based on a data monitoring device, and control the accurate release of drugs based on the monitoring results, thereby achieving more timely and accurate elimination of the user's vaginal pathogens and providing more intelligent auxiliary services for the user's treatment.

[0005] In order to solve the above technical problems, the first aspect of the present invention discloses a drug sustained-release control system for intelligently monitoring vaginal environment, the system comprising:

[0006] A data monitoring device, disposed in the vaginal area of ​​the target user, for acquiring sensor data of the vaginal area;

[0007] A data processing device, connected to the data monitoring device, for determining a drug release instruction corresponding to the target user based on the sensor data;

[0008] A drug sustained-release device stores therapeutic drugs, is disposed in the vaginal area, and is connected to the data processing device, and is used to release the therapeutic drugs into the vaginal area according to the drug release instruction to treat the target user.

[0009] As an optional embodiment, the data monitoring device includes a pH sensor, a temperature sensor, a humidity sensor and a data transmission module; the pH sensor, the temperature sensor and the humidity sensor are all connected to the data transmission module; the data transmission module transmits the sensor data acquired by the pH sensor, the temperature sensor and the humidity sensor to the data processing device based on Bluetooth technology.

[0010] As an optional implementation, the sensor data includes pH value data, temperature data and humidity data; the data processing device includes:

[0011] A data correction module, used for mutually correcting any two pieces of the sensing data according to a data verification rule to obtain corrected sensing data;

[0012] A flora prediction module, used for inputting the pH value data in the corrected sensor data into the trained flora prediction neural network to obtain an output flora abnormality degree value;

[0013] An inflammation prediction module, used for inputting the temperature data in the corrected sensor data into a trained inflammation prediction neural network to obtain an output abnormal degree value of inflammation;

[0014] A secretion prediction module, used for inputting the humidity data in the corrected sensor data into the trained secretion prediction neural network to obtain an output secretion abnormality degree value;

[0015] The comprehensive analysis module is used to determine the drug release instruction corresponding to the target user according to the abnormal flora degree value, the abnormal inflammation degree value and the abnormal secretion degree value.

[0016] As an optional implementation, the specific manner in which the comprehensive analysis module determines the drug release instruction corresponding to the target user includes:

[0017] Determine whether any one of the abnormal flora value, the abnormal inflammation value, and the abnormal secretion value is within a corresponding abnormal value interval to obtain a first determination result;

[0018] If the first judgment result is no, determining that the drug release instruction is an instruction that does not require release;

[0019] If the first judgment result is yes, the abnormal flora value, the abnormal inflammation value or the abnormal secretion value within the abnormal value interval is determined as current abnormal data;

[0020] Acquire historical abnormal data of the target user at at least one historical time point of the same data type as the current abnormal data;

[0021] The drug release instruction corresponding to the target user is determined according to the current abnormal data and the historical abnormal data.

[0022] As an optional implementation manner, the comprehensive analysis module determines the specific manner of the drug release instruction corresponding to the target user according to the current abnormal data and the historical abnormal data, including:

[0023] Calculating a data difference between the current abnormal data and the historical abnormal data;

[0024] Calculating the time difference between the data acquisition time point corresponding to the current abnormal data and the historical time point corresponding to the historical abnormal data;

[0025] Calculate the ratio of the data difference to the time difference to obtain an abnormal change parameter; the abnormal change parameter retains positive and negative values;

[0026] Determine whether the abnormal change parameters corresponding to the target user at multiple time points meet the preset abnormal mitigation data rules to obtain a second determination result;

[0027] If the second judgment result is yes, generating a drug release amount parameter inversely proportional to the absolute value of the abnormal change parameter;

[0028] If the second judgment result is no, generating a drug release amount parameter that is proportional to the absolute value of the abnormal change parameter;

[0029] A drug release instruction corresponding to the target user is generated according to the drug release amount parameter; the drug release instruction is used to instruct the drug release device to release the therapeutic drug with a measured value corresponding to the drug release amount parameter.

[0030] As an optional implementation, the data transmission module includes:

[0031] A power management unit, used to manage and monitor the capacity of the power supply of the drug sustained-release control system;

[0032] An encryption unit, used for encrypting the sensor data to obtain encrypted data;

[0033] A Bluetooth transmission unit is used to transmit the encrypted data to the data processing device based on Bluetooth technology.

[0034] As an optional implementation manner, the encryption unit encrypts the sensor data to obtain encrypted data in a specific manner including:

[0035] Generate a first key based on a true random number generator and generate a certificate corresponding to the first key;

[0036] Acquire sensor data of the target user at a previous historical time point, and generate a second key based on the sensor data at the previous historical time point and a preset data mapping rule;

[0037] Based on a preset data vector calculation rule, generating an encryption key according to the first key and the second key;

[0038] Encrypting the sensor data according to the encryption key to obtain encrypted data;

[0039] The Bluetooth transmission unit transmits the encrypted data and the certificate to the data processing device; the data processing device decrypts the encrypted data based on the certificate and the sensor data at the previous historical time point to obtain the sensor data.

[0040] As an optional embodiment, the drug sustained-release device comprises:

[0041] shell;

[0042] Three mutually independent drug storage areas are arranged in the shell, respectively storing antibacterial drugs, clotrimazole and nanosilver;

[0043] A drug controlled release layer is disposed between the drug storage area and the shell; the drug controlled release layer is used to receive the drug release command to release the therapeutic drug.

[0044] As an optional embodiment, the drug controlled release layer includes a first layer, a second layer and a third layer arranged from the drug storage area to the shell; the first layer is made of polyvinyl alcohol hydrogel material and is a response layer with a thickness of 200 microns. The first layer remains in a semi-expanded state under the normal human body temperature of 37°C to maintain the basic drug release rate. When the temperature of the local tissue rises to more than 38°C due to inflammation, the hydrogel network structure of the first layer will further expand to promote drug release; the first layer has a sensitive response characteristic to external electric field stimulation, and the hydrogel layer of the first layer can be induced to undergo controllable deformation by applying a weak electric field of 3-5V: The second layer is made of polyacrylate copolymer material with a thickness of 150 microns. The second layer has a unique pH response mechanism. When the pH value of the local environment rises above 4.5, the carboxyl groups in the second layer material will undergo ionization, causing the network structure to expand significantly, triggering the rapid release of clotrimazole. The built-in microelectrode array of the second layer receives the electrical signal of the drug release command from the data processing device, and realizes dynamic regulation of the second layer network structure to control the amount of drug released. The third layer is made of PDMS material with a thickness of 100 microns. pH sensitive groups are introduced through surface modification technology, and it has environmental responsiveness and selective permeability characteristics.

[0045] As an optional embodiment, the shell is made of medical grade silicone material; the outer wall of the drug storage area is provided with a drug diffusion channel with a micropore array structure, the micropore diameter is 100-200 microns, the pore spacing is 500 microns, and it is staggered at a 45-degree angle to control drug release.

[0046] Compared with the prior art, the present invention has the following beneficial effects:

[0047] The present invention can monitor the user's vaginal environment in real time and accurately based on the data monitoring device, and control the accurate release of the drug based on the monitoring results, which can achieve more timely and accurate elimination of the user's vaginal pathogens and provide more intelligent auxiliary services for the user's treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0049] Figure 1 It is a structural schematic diagram of a drug sustained-release control system for intelligently monitoring vaginal environment disclosed in an embodiment of the present invention.

[0050] Figure 2 It is a structural schematic diagram of a drug sustained-release control device disclosed in an embodiment of the present invention.

[0051] Figure 3 It is a schematic diagram of the sensor layout structure of a multi-parameter monitoring system disclosed in an embodiment of the present invention. DETAILED DESCRIPTION

[0052] In order to enable those skilled in the art to better understand the scheme of the present invention, the technical scheme in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0053] The terms "first", "second", etc. in the specification and claims of the present invention and the above-mentioned drawings are used to distinguish different objects, rather than to describe a specific order. In addition, the terms "including" and "having" and any variations thereof are intended to cover non-exclusive inclusions. For example, a process, method, device, product or end including a series of steps or modules is not limited to the listed steps or modules, but may optionally include steps or modules that are not listed, or may optionally include other steps or modules that are inherent to these processes, methods, products or ends.

[0054] Reference to "embodiments" herein means that a particular feature, structure, or characteristic described in conjunction with the embodiments may be included in at least one embodiment of the present invention. The appearance of the phrase in various places in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment that is mutually exclusive with other embodiments. It is explicitly and implicitly understood by those skilled in the art that the embodiments described herein may be combined with other embodiments.

[0055] The present invention aims to provide an innovative drug sustained-release control system for intelligently monitoring the vaginal environment, which can monitor the user's vaginal environment in real time and accurately based on a data monitoring device, and control the accurate release of drugs based on the monitoring results, thereby achieving more timely and accurate elimination of the user's vaginal pathogens and providing more intelligent auxiliary services for the user's treatment.

[0056] For details, please refer to Figure 1 , Figure 1 Schematic diagram of a drug sustained-release control system for intelligently monitoring vaginal environment disclosed in an embodiment of the present invention. Figure 1 As shown, the drug sustained-release control system for intelligently monitoring the vaginal environment includes at least:

[0057] A data monitoring device, disposed in the vaginal area of ​​the target user, for acquiring sensing data of the vaginal area;

[0058] A data processing device, connected to the data monitoring device, for determining a drug release instruction corresponding to a target user based on the sensor data;

[0059] The drug sustained-release device stores therapeutic drugs, is arranged in the vaginal area, and is connected to the data processing device, and is used to release the therapeutic drugs into the vaginal area according to the drug release instruction to treat the target user.

[0060] As an optional embodiment, the data monitoring device includes a pH sensor, a temperature sensor, a humidity sensor and a data transmission module; the pH sensor, the temperature sensor and the humidity sensor are all connected to the data transmission module.

[0061] Specifically, the data transmission module transmits the sensing data acquired by the pH sensor, the temperature sensor and the humidity sensor to the data processing device based on the Bluetooth technology.

[0062] As an optional embodiment, the sensing data includes pH value data, temperature data and humidity data; and the data processing device includes:

[0063] A data correction module is used to perform mutual correction on any two pieces of sensor data according to a data verification rule to obtain corrected sensor data;

[0064] A flora prediction module is used to input the pH value data in the corrected sensor data into the trained flora prediction neural network to obtain an output flora abnormality degree value;

[0065] The inflammation prediction module is used to input the temperature data in the corrected sensor data into the trained inflammation prediction neural network to obtain the output value of the abnormal degree of inflammation;

[0066] A secretion prediction module is used to input the humidity data in the corrected sensor data into the trained secretion prediction neural network to obtain an output secretion abnormality degree value;

[0067] The comprehensive analysis module is used to determine the drug release instructions corresponding to the target user based on the abnormal flora degree value, the abnormal inflammation degree value and the abnormal secretion degree value.

[0068] As an optional embodiment, the specific manner in which the comprehensive analysis module determines the drug release instruction corresponding to the target user includes:

[0069] Determine whether any one of the abnormal flora degree value, the abnormal inflammation degree value, and the abnormal secretion degree value is within a corresponding abnormal value interval to obtain a first determination result;

[0070] If the first judgment result is no, determining that the drug release instruction is a release-free instruction;

[0071] If the first judgment result is yes, the abnormal flora degree value, the abnormal inflammation degree value or the abnormal secretion degree value within the abnormal value range is determined as the current abnormal data;

[0072] Obtain historical abnormal data of the target user at least one historical time point of the same data type as the current abnormal data;

[0073] According to the current abnormal data and historical abnormal data, the drug release instructions corresponding to the target user are determined.

[0074] As an optional embodiment, the comprehensive analysis module determines the specific manner of the drug release instruction corresponding to the target user according to the current abnormal data and the historical abnormal data, including:

[0075] Calculate the data difference between current abnormal data and historical abnormal data;

[0076] Calculate the time difference between the data acquisition time point corresponding to the current abnormal data and the historical time point corresponding to the historical abnormal data;

[0077] Calculate the ratio of the data difference and the time difference to obtain the abnormal change parameter; the abnormal change parameter retains positive and negative values;

[0078] Determine whether the abnormal change parameters corresponding to the target user at multiple time points meet the preset abnormal mitigation data rules to obtain a second determination result;

[0079] If the second judgment result is yes, generating a drug release amount parameter that is inversely proportional to the absolute value of the abnormal change parameter;

[0080] If the second judgment result is no, generating a drug release amount parameter that is proportional to the absolute value of the abnormal change parameter;

[0081] A drug release instruction corresponding to the target user is generated according to the drug release amount parameter; the drug release instruction is used to instruct the drug release device to release the therapeutic drug with a measured value corresponding to the drug release amount parameter.

[0082] As an optional embodiment, the data transmission module includes:

[0083] A power management unit, used to manage and monitor the capacity of the power supply of the drug sustained-release control system;

[0084] An encryption unit, used for encrypting the sensor data to obtain encrypted data;

[0085] The Bluetooth transmission unit is used to transmit the encrypted data to the data processing device based on the Bluetooth technology.

[0086] As an optional embodiment, the encryption unit encrypts the sensor data to obtain encrypted data in a specific manner including:

[0087] generating a first key based on a true random number generator and generating a certificate corresponding to the first key;

[0088] Acquire sensor data of the target user at a previous historical time point, and generate a second key based on the sensor data at the previous historical time point and a preset data mapping rule;

[0089] Generate an encryption key based on a preset data vector calculation rule and the first key and the second key;

[0090] Encrypting the sensor data according to the encryption key to obtain encrypted data;

[0091] The Bluetooth transmission unit transmits the encrypted data and the certificate to the data processing device; the data processing device decrypts the encrypted data based on the certificate and the sensor data at the previous historical time point to obtain the sensor data.

[0092] As an optional embodiment, the drug sustained-release device comprises:

[0093] shell;

[0094] Three independent drug storage areas are arranged in the shell, respectively storing antibacterial drugs, clotrimazole and nanosilver;

[0095] A drug controlled release layer is arranged between the drug storage area and the shell; the drug controlled release layer is used to receive a drug release command to release the therapeutic drug.

[0096] As an optional embodiment, the drug controlled release layer includes a first layer, a second layer and a third layer arranged from the drug storage area to the shell; the first layer is made of polyvinyl alcohol hydrogel material, which is a response layer with a thickness of 200 microns. The first layer remains in a semi-expanded state under the normal human body temperature of 37°C to maintain the basic drug release rate. When the temperature of the local tissue rises to more than 38°C due to inflammation, the hydrogel network structure of the first layer will further expand to promote drug release; the first layer has sensitive response characteristics to external electric field stimulation, and the application of a weak electric field of 3-5V can induce the hydrogel layer of the first layer to undergo controllable deformation: the second layer is made of polyacrylate copolymer material, with a thickness of 150 microns, and the second layer has a unique pH response mechanism. When the local environment pH value rises above 4.5, the carboxyl groups in the second layer of material will undergo ionization, causing the network structure to expand significantly, triggering the rapid release of clotrimazole; the built-in microelectrode array in the second layer receives the electrical signal of the drug release command from the data processing device, realizing dynamic regulation of the second layer network structure to control the amount of drug released; the third layer uses PDMS material with a thickness of 100 microns, and pH sensitive groups are introduced through surface modification technology, which has environmental responsiveness and selective permeability characteristics.

[0097] As an optional embodiment, the shell is made of medical grade silicone material; the outer wall of the drug storage area is provided with a drug diffusion channel with a micropore array structure, the micropore diameter is 100-200 microns, the pore spacing is 500 microns, and it is staggered at a 45-degree angle to control drug release.

[0098] In a specific embodiment, Figure 2 As shown, the drug sustained-release system, multi-parameter monitoring system and data transmission system are integrated to form a complete intelligent drug sustained-release control device, realizing the synergistic function of drug sustained-release and environmental monitoring. The overall ring structure is adopted, and the multi-layer sealing design of medical-grade silicone shell, double O-ring seal and 316L stainless steel battery compartment ensures that the system reaches IP68 waterproof level and meets the requirements of long-term use. Specifically, the multi-layer sealing design includes the shell sealing system, the battery compartment sealing system and the waterproof test system;

[0099] The shell sealing system includes: a medical-grade silicone shell, which is made of liquid silicone injection molding, with a Shore hardness of 50A and a tensile strength greater than 6MPa; the shell wall thickness is 2mm, and the surface roughness Ra is less than 0.8μm; a positioning boss is provided inside the shell, with a height of 1.5mm, for fixing the circuit board assembly; the shell joint surface adopts a maze-type groove design, with a groove depth of 0.8mm and a groove width of 1mm.

[0100] The battery compartment sealing system includes: a battery compartment body precision-machined from 316L stainless steel, with a wall thickness of 1mm and an electrolytically polished surface; a double O-ring sealing structure, with an inner ring diameter of 20mm, an outer ring diameter of 22mm, and a cross-sectional diameter of 1.5mm; the O-ring is made of fluororubber, with a Shore hardness of 70A and a compression deformation rate of 25%; the battery compartment cover adopts a threaded sealing structure, with a thread specification of M20×1.5 and a torque of 4N·m.

[0101] The waterproof test system meets the following requirements: static water pressure test: no leakage after immersion for 72 hours in a water depth of 2 meters; dynamic impact test: withstand the impact pressure of water flow at a height of 1.5 meters for no less than 30 minutes; temperature cycle test: under the temperature cycle conditions of 5-50℃, the sealing performance does not decrease after 10 cycles; vibration test: vibrate for 2 hours in the frequency range of 10-55Hz, with an acceleration of 1.5g, and the sealing performance remains intact.

[0102] The connection between the shell sealing system and the battery compartment sealing system adopts a double protection structure of a buckle and a sealing ring: the buckle is made of stainless steel spring sheet with a thickness of 0.3mm and an elastic force of not less than 20N; the sealing ring is made of silicone rubber with a compression rate of 30% and a cross-sectional diameter of 2mm; the connection adopts 8 fixed points distributed in a 360-degree ring, and each fixed point is 45 degrees apart.

[0103] like Figure 3 As shown, the three types of sensors of the multi-parameter monitoring system are evenly distributed at 120 degrees on the periphery of the ring structure. Among them, the pH sensor adopts ISFET technology, has a size of 3mm×3mm, and a monitoring range of 2-12pH; the temperature sensor adopts a medical-grade PT100 platinum resistor, has a size of 2mm×2mm, and a monitoring range of 30-45℃; the humidity sensor adopts a capacitive sensor, has a size of 4mm×4mm, and a monitoring range of 0-100%RH. The sensors are electrically connected through a flexible printed circuit board to ensure that stable electrical performance is maintained when the ring structure is bent and deformed. Specifically, the multi-parameter monitoring system includes an integrated sensor module and a signal conditioning circuit, wherein the integrated sensor module includes: a pH sensor unit, a temperature sensor unit, a humidity sensor unit, and a sensor layout structure:

[0104] The pH sensor unit includes: an ISFET device with fast response and calibration-free characteristics, wherein the sensitive film is made of hafnium oxide material with a thickness of 50 nm; a reference electrode with an Ag / AgCl structure is provided, and the electrode potential drift is less than 0.1 mV / h; the drain current sensitivity of the ISFET device is greater than 50 mV / pH;

[0105] The temperature sensor unit includes: a medical-grade PT100 platinum resistor using a four-wire measurement method; the temperature coefficient of the PT100 platinum resistor is 0.385Ω / ℃, and the self-heating effect is less than 0.1℃ / mW; the temperature measurement range is 30-45℃, and the accuracy is ±0.1℃;

[0106] The humidity sensor unit comprises: a capacitive sensor based on a polyimide substrate; the base capacitance value of the capacitive sensor is 180pF and the sensitivity is 0.3pF / %RH; a temperature compensation circuit is set, the compensation range is 30-45°C, and the humidity hysteresis is less than ±1%RH;

[0107] The sensor layout structure includes: a flexible printed circuit board with a thickness of 0.2mm; the printed circuit board adopts the gold immersion process, the line width is 0.1mm, and the line spacing is 0.1mm; the sensor is fixed with high-temperature medical-grade epoxy resin, and the shear strength is greater than 5MPa.

[0108] Among them, the signal conditioning circuit includes:

[0109] pH signal processing unit, temperature signal processing unit, humidity signal processing unit and anti-interference protection unit;

[0110] The pH signal processing unit includes: using AD8628 low-noise operational amplifier, input offset voltage is less than 5μV; setting a second-order Butterworth low-pass filter, cut-off frequency is 100Hz; integrating active temperature compensation circuit, temperature drift is less than 0.1pH / ℃;

[0111] The temperature signal processing unit includes: adopting a Wheatstone bridge circuit structure, an excitation voltage of 3.3V; setting an INA333 instrument amplifier, a common mode rejection ratio of 110dB; integrating a third-order Chebyshev filter, a cut-off frequency of 10Hz;

[0112] The humidity signal processing unit includes: a capacitance-to-digital conversion circuit based on the AD7747 chip; a sampling rate set to 100 Hz, a resolution of 16 bits; and output signals through an SPI interface with a clock frequency of 1 MHz;

[0113] The anti-interference protection unit includes: a multi-layer PCB design with separated signal layer and power layer; an independent LDO voltage regulator circuit with a ripple less than 1mVpp; and an electromagnetic shielding layer with a shielding effect greater than 60dB.

[0114] Among them, Figure 2As shown, the drug sustained-release system includes: an annular matrix, a drug storage cavity, a drug diffusion channel and a controlled release layer. The annular matrix is ​​made of medical-grade silicone material, with an outer diameter of 54 mm, an inner diameter of 45 mm, a circular cross-section and a diameter of 4.5 mm. The drug storage cavity is arranged inside the annular matrix, distributed in an annular shape, with an internal space volume of 2.5 ml, and is divided into three independent drug storage areas, which are used to store antibacterial drugs, clotrimazole and nanosilver, respectively. The antibacterial drug area is used to release broad-spectrum antibacterial drugs to establish the first line of defense against bacterial infections; the clotrimazole area is specifically for fungal infections, especially Candida, and forms a complementary treatment with antibacterial drugs; the nanosilver area prevents the generation of drug-resistant strains through its continuous bactericidal effect and biofilm inhibition effect, and enhances the therapeutic effects of antibacterial drugs and clotrimazole.

[0115] The release of the three drugs adopts a synergistic mechanism: the antibacterial drug is first released quickly to control the infection, clotrimazole is targeted and released under pH response conditions, and nanosilver is continuously and slowly released to maintain the therapeutic effect. The three storage areas are strictly separated by partitions to avoid drug interactions affecting the therapeutic effect, and the timed release amount and synergistic enhancement of the drugs are achieved by controlling the release layer. Specifically, the drug diffusion channel is set on the outer wall of the drug storage cavity, adopting a micropore array structure with a micropore diameter of 100-200 microns and a pore spacing of 500 microns, staggered at a 45-degree angle; the controlled release layer includes: the inner layer is a polyvinyl alcohol hydrogel layer with a thickness of 200 microns, which is used to control the initial release rate of the drug; the middle layer is a polyacrylate copolymer layer with a thickness of 150 microns, which is used to achieve pH responsive release; the outer layer is a medical-grade PDMS protective layer with a thickness of 100 microns, which is used to provide biocompatibility protection; the three layers are concentrically coated on the outer wall of the drug storage cavity, and the plasma surface treatment technology is used to achieve close bonding between the layers, and the bonding strength is not less than 2MPa. The controlled release layer of the drug sustained-release system adopts an innovative three-layer intelligent response structure design, which realizes precise control of drug release by combining material property changes and electric field regulation. The innermost layer uses polyvinyl alcohol hydrogel material to construct a response layer with a thickness of 200 microns. This layer remains in a semi-expanded state under normal human body temperature of 37°C to maintain the basic drug release rate. When the temperature of the local tissue rises to more than 38°C due to inflammation, the hydrogel network structure will further expand to promote drug release. At the same time, this layer also has sensitive response characteristics to external electric field stimulation. By applying a weak electric field of 3-5V, the hydrogel layer can be induced to undergo controllable deformation, thereby actively adjusting the release kinetics of the drug and realizing intelligent control of on-demand drug delivery.

[0116] The middle layer is made of polyacrylate copolymer material, and its thickness is precisely controlled to be 150 microns. This layer has a unique pH response mechanism. Under normal vaginal pH environment (3.8-4.5), the molecular chains are tightly coiled to form a dense network structure to achieve slow release of drugs. When the local environmental pH value rises above 4.5 (usually indicating pathological changes), the carboxyl groups in the material will undergo ionization, causing the network structure to expand significantly, thereby triggering the rapid release of drugs such as clotrimazole. This layer can also receive electrical signals from the control system through the built-in microelectrode array to achieve dynamic regulation of the network structure, thereby synergistically controlling the release behavior of multiple drugs.

[0117] The outermost layer uses specially modified medical-grade PDMS material with a precisely controlled thickness of 100 microns, creating a protective layer with intelligent barrier function. This layer introduces pH-sensitive groups through surface modification technology, making it environmentally responsive and selectively permeable, which can effectively block the invasion of harmful substances such as bacteria, while allowing therapeutic drug molecules to penetrate in a directional manner. The outer layer and the middle layer form a unique composite response area at the interface, which further optimizes the control accuracy of drug release through synergy.

[0118] These three layers of functional materials are tightly bonded with a strength of no less than 2MPa through a precisely controlled plasma surface treatment process. The system arranges microelectrode arrays between the layers, forming a complete intelligent control loop with the microcontroller. The microcontroller collects environmental parameters in real time and communicates with the server or terminal device based on the communication module to output precise control signals in combination with the preset drug delivery strategy. Doctors can remotely adjust drug delivery parameters through the Bluetooth interface to achieve real-time optimization of treatment plans, thereby ensuring the accuracy and individualization of the treatment process. The entire system achieves precise control of drug release throughout the entire process through the organic combination of the intelligent response characteristics of the material and the electric field control method, providing patients with a more optimized treatment experience.

[0119] Specifically, the microcontroller unit includes a core processing system, a data acquisition system, a data processing system and a system management module. The core processing system includes: a 32-bit ARMCortex-M4 processor with a main frequency of 80MHz; 128KB SRAM and 512KB Flash memory; an integrated hardware floating point unit FPU, supporting DSP instruction set; the data acquisition system includes: a built-in 12-bit ADC converter with a sampling rate of 1kHz; 8 signal acquisition channels are set, and the sampling and holding time is 2.5μs; a DMA controller is configured to support automatic data transmission; the data processing system includes: implementing a digital filtering algorithm, and the signal-to-noise ratio is improved by 20dB; integrating abnormal value detection and data smoothing processing functions; supporting data compression storage, and can record 30 days of monitoring data; the system management module includes: supporting multi-level low-power management functions, dynamically adjusting the system working state; setting watchdog protection, and the system self-recovery time is less than 100ms; integrating a real-time clock, and the time error is less than 1 minute / month.

[0120] Specifically, the medical-grade PDMS coating layer includes: a base treatment layer, a functional coating layer and a surface protection layer.

[0121] The preparation process of the basic treatment layer includes: using plasma surface treatment technology, with the power set to 50W, the treatment time to 60 seconds, the treatment gas to be oxygen, and the gas pressure to be 50Pa, so that a hydroxyl activation layer is formed on the sensor surface; spin coating the silane coupling agent KH-550 on the activation layer, with a rotation speed of 3000rpm, a time of 30 seconds, a curing temperature of 80°C, and a time of 2 hours, to form a coupling layer with a thickness of 50 nanometers.

[0122] The preparation process of the functional coating layer includes: using medical-grade PDMS prepolymer, in which the mass ratio of the matrix to the cross-linking agent is 10:1; using a reduced pressure stirring process with a rotation speed of 500 rpm, a time of 10 minutes, a vacuum degree of -0.1 MPa, and removing bubbles; using precision dispensing equipment for coating, with a dispensing pressure of 0.3 MPa and a dispensing speed of 2 mm / s to form a uniform coating layer with a thickness of 150 microns; curing at 80°C for 2 hours to form a cross-linked network structure.

[0123] The preparation process of the surface protection layer includes: using modified PDMS material containing 2% hydrophilic groups; using plasma treatment technology for surface modification, with a power of 30W and a time of 30 seconds; using a spraying process to form a protective layer with a thickness of 50 microns, a spraying pressure of 0.2MPa, a distance of 10cm, and a spraying angle of 45 degrees.

[0124] Furthermore, the sensor was coated with a PDMS coating layer. The preparation process of the PDMS coating layer included three key steps: first, the sensor surface was plasma treated to form a hydroxyl activation layer under the conditions of 50W power, 60 seconds treatment time, and 50Pa oxygen pressure, followed by spin coating of silane coupling agent KH-550 (3000rpm, 30 seconds) and curing at 80°C for 2 hours to form a 50nm thick coupling layer; second, medical-grade PDMS prepolymer (matrix and cross-linking The functional coating was carried out by stirring at reduced pressure (500 rpm, 10 minutes, -0.1 MPa) to remove bubbles, and a 150-micron-thick uniform coating layer was formed using precision dispensing equipment (pressure 0.3 MPa, speed 2 mm / s), which was cured at 80°C for 2 hours. Finally, a modified PDMS material containing 2% hydrophilic groups was used, and after plasma treatment at 30 W power and 30 seconds, a 50-micron-thick protective layer was formed by spraying at a 45-degree angle under a pressure of 0.2 MPa.

[0125] Furthermore, the data transmission system consists of a Bluetooth communication module, a data encryption processing unit and a power management system. The Bluetooth communication module adopts the Bluetooth 5.2 low-power protocol, supports the 2.4GHz frequency band, and has an adjustable transmission power range of -20dBm to +4dBm; it adopts a PCB onboard antenna design with an antenna gain of 3dBi and a standing wave ratio of less than 1.5; the data transmission rate can reach 2Mbps, and the communication distance is not less than 10 meters in an open environment; the RF circuit adopts an impedance matching design with a characteristic impedance of 50 ohms and a return loss of less than -15dB.

[0126] The data encryption processing unit includes: a hardware accelerator based on the AES-128 encryption algorithm, with a clock frequency of 80MHz; a true random number generator is used to generate keys, the entropy source comes from thermal noise, and it has passed the NISTSP800-22 test; the data encryption packet size is 128 bits, the encryption delay is less than 1ms, and the throughput is greater than 1Mbps; CBC encryption mode and CMAC authentication are implemented, and the key is regularly updated every 24 hours;

[0127] The power management system includes: powered by CR2032 lithium battery, nominal voltage 3V, capacity 220mAh; power management chip supports low voltage dropout regulated output, output voltage 3.3V±1%; sleep current is less than 1μA, working current peak is less than 20mA; with battery power monitoring function, low power alarm threshold is 2.2V;

[0128] The Bluetooth communication module is connected to the data encryption processing unit through the SPI bus, with a clock frequency of 4MHz and a 4-wire interface. A star power supply topology is adopted between the power management system and each functional unit, with a power supply trace width of 0.5mm, and a 45-degree wiring design is used between devices to reduce electromagnetic interference.

[0129] An example of a working process of the smart medical device is as follows:

[0130] 1. The doctor injects the medicine into the three drug storage chambers respectively and places the device into the patient's vagina using a special tool.

[0131] 2. After the device starts working, the drug sustained-release system achieves sustained release of drugs through the microporous array structure and three-layer controlled release layer.

[0132] 3. The multi-parameter monitoring system collects pH, temperature and humidity data of the vaginal environment in real time.

[0133] 4. The data transmission system encrypts the collected data and transmits it to the patient’s mobile device and remote server via low-power Bluetooth technology.

[0134] 5. Doctors can view monitoring data in real time through dedicated software, and the remote server can evaluate the vaginal environment based on algorithms and give drug sustained-release control instructions to control drug release.

[0135] It can be seen that this specific implementation plan integrates a drug sustained-release system, a multi-parameter monitoring system and a data transmission system, which can achieve long-term sustained-release of drugs, real-time monitoring of the vaginal environment and safe transmission of data, significantly improving the treatment effect and patient experience.

[0136] The above describes specific embodiments of the present specification, and other embodiments are within the scope of the appended claims. In some cases, the actions or steps recorded in the claims can be performed in an order different from that in the embodiments and still achieve the desired results. In addition, the processes depicted in the accompanying drawings do not necessarily have to be performed in the specific order or sequential order shown to achieve the desired results. In some embodiments, multitasking and parallel processing are also possible or may be advantageous.

[0137] Each embodiment in this specification is described in a progressive manner, and the same or similar parts between the embodiments can be referred to each other, and each embodiment focuses on the differences from other embodiments. In particular, for the device, equipment, and non-volatile computer-readable storage medium embodiments, since they are basically similar to the method embodiments, the description is relatively simple, and the relevant parts can be referred to the partial description of the method embodiments.

[0138] The apparatus, device, non-volatile computer-readable storage medium and method provided in the embodiments of this specification correspond to each other, and therefore, the apparatus, device, and non-volatile computer storage medium also have similar beneficial technical effects as the corresponding methods. Since the beneficial technical effects of the methods have been described in detail above, the beneficial technical effects of the corresponding apparatus, device, and non-volatile computer storage medium will not be repeated here.

[0139] In the 1990s, improvements to a technology could be clearly distinguished as hardware improvements (for example, improvements to the circuit structure of diodes, transistors, switches, etc.) or software improvements (improvements to the method flow). However, with the development of technology, many improvements to the method flow today can be regarded as direct improvements to the hardware circuit structure. Designers almost always obtain the corresponding hardware circuit structure by programming the improved method flow into the hardware circuit. Therefore, it cannot be said that an improvement in a method flow cannot be implemented using a hardware entity module. For example, a programmable logic device (PLD) (such as a field programmable gate array (FPGA)) is such an integrated circuit whose logical function is determined by the user's programming of the device. Designers can "integrate" a digital system on a PLD by programming it themselves, without having to ask a chip manufacturer to design and produce a dedicated integrated circuit chip. Moreover, nowadays, instead of manually making integrated circuit chips, this kind of programming is mostly implemented by "logic compiler" software, which is similar to the software compiler used when developing and writing programs, and the original code before compilation must also be written in a specific programming language, which is called hardware description language (HDL). There is not only one HDL, but many kinds, such as ABEL (Advanced Boolean Expression Language), AHDL (Altera Hardware Description Language), Confluence, CUPL (Cornell University Programming Language), HDCal, JHDL (Java Hardware Description Language), Lava, Lola, MyHDL, PALASM, RHDL (Ruby Hardware Description Language), etc. The most commonly used ones are VHDL (Very-High-Speed ​​Integrated Circuit Hardware Description Language) and Verilog. Those skilled in the art should also know that it is only necessary to program the method flow slightly in the above-mentioned hardware description languages ​​and program it into the integrated circuit, and then it is easy to obtain the hardware circuit that implements the logic method flow.

[0140] The controller can be implemented in any appropriate manner, for example, the controller can take the form of a microprocessor or processor and a computer-readable medium storing a computer-readable program code (such as software or firmware) that can be executed by the (micro)processor, a logic gate, a switch, an application-specific integrated circuit (ASIC), a programmable logic controller, and an embedded microcontroller. Examples of controllers include, but are not limited to, the following microcontrollers: ARC 625D, Atmel AT91SAM, Microchip PIC18F26K20, and Silicone Labs C8051F320. The memory controller can also be implemented as part of the control logic of the memory. Those skilled in the art also know that in addition to implementing the controller in a purely computer-readable program code manner, the controller can be implemented in the form of a logic gate, a switch, an application-specific integrated circuit, a programmable logic controller, and an embedded microcontroller by logically programming the method steps. Therefore, this controller can be considered as a hardware component, and the devices included therein for implementing various functions can also be regarded as structures within the hardware component. Or even, the devices for implementing various functions can be regarded as both software modules for implementing the method and structures within the hardware component.

[0141] The systems, devices, modules or units described in the above embodiments may be implemented by computer chips or entities, or by products with certain functions. A typical implementation device is a computer. Specifically, the computer may be, for example, a personal computer, a laptop computer, a cellular phone, a camera phone, a smart phone, a personal digital assistant, a media player, a navigation device, an email device, a game console, a tablet computer, a wearable device, or a combination of any of these devices.

[0142] For the convenience of description, the above device is described in various units according to their functions. Of course, when implementing this specification, the functions of each unit can be implemented in the same or multiple software and / or hardware.

[0143] Those skilled in the art will appreciate that the embodiments of this specification may be provided as methods, systems, or computer program products. Therefore, the embodiments of this specification may be in the form of complete hardware embodiments, complete software embodiments, or embodiments in combination with software and hardware. Moreover, the embodiments of this specification may be in the form of a computer program product implemented in one or more computer-usable storage media (including but not limited to disk storage, CD-ROM, optical storage, etc.) that contain computer-usable program code.

[0144] This specification is described with reference to the flowcharts and / or block diagrams of the methods, devices (systems), and computer program products according to the embodiments of this specification. It should be understood that each process and / or box in the flowchart and / or block diagram, as well as the combination of the processes and / or boxes in the flowchart and / or block diagram, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer, an embedded processor, or other programmable data processing device to produce a machine, so that the instructions executed by the processor of the computer or other programmable data processing device generate instructions for implementing the processes in the flowchart and / or block diagram. Figure 1 A process or multiple processes and / or boxes Figure 1 A device that provides the functions specified in a block or multiple blocks.

[0145] These computer program instructions may also be stored in a computer-readable memory capable of directing a computer or other programmable data processing device to operate in a specific manner, so that the instructions stored in the computer-readable memory produce an article of manufacture comprising an instruction device, which implements the process Figure 1 A process or multiple processes and / or boxes Figure 1 A function specified in one or more boxes.

[0146] These computer program instructions can also be loaded onto a computer or other programmable data processing device so that a series of operating steps are executed on the computer or other programmable device to produce a computer-implemented process, thereby providing instructions for implementing the process. Figure 1 A process or multiple processes and / or boxes Figure 1 The steps for the functions specified in one or more boxes.

[0147] In a typical configuration, a computing device includes one or more processors (CPU), input / output interfaces, network interfaces, and memory.

[0148] The memory may include non-permanent storage in a computer-readable medium, random access memory (RAM) and / or non-volatile memory in the form of read-only memory (ROM) or flash RAM. The memory is an example of a computer-readable medium.

[0149] Computer readable media include permanent and non-permanent, removable and non-removable media that can be implemented by any method or technology to store information. Information can be computer readable instructions, data structures, program modules or other data. Examples of computer storage media include, but are not limited to, phase change memory (PRAM), static random access memory (SRAM), dynamic random access memory (DRAM), other types of random access memory (RAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), flash memory or other memory technology, compact disk read-only memory (CD-ROM), digital versatile disk (DVD) or other optical storage, magnetic cassettes, magnetic disk storage or other magnetic storage devices or any other non-transmission media that can be used to store information that can be accessed by a computing device. As defined herein, computer readable media does not include temporary computer readable media (transitory media), such as modulated data signals and carrier waves.

[0150] It should also be noted that the terms "include", "comprises" or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, commodity or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, commodity or device. In the absence of more restrictions, the elements defined by the sentence "comprises a ..." do not exclude the existence of other identical elements in the process, method, commodity or device including the elements.

[0151] This specification may be described in the general context of computer-executable instructions executed by a computer, such as program modules. Generally, program modules include routines, programs, objects, components, data structures, etc. that perform specific tasks or implement specific abstract data types. This specification may also be practiced in distributed computing environments where tasks are performed by remote processing devices connected through a communication network. In a distributed computing environment, program modules may be located in local and remote computer storage media, including storage devices.

[0152] Each embodiment in this specification is described in a progressive manner, and the same or similar parts between the embodiments can be referred to each other, and each embodiment focuses on the differences from other embodiments. In particular, for the system embodiment, since it is basically similar to the method embodiment, the description is relatively simple, and the relevant parts can be referred to the partial description of the method embodiment.

[0153] Finally, it should be noted that the intelligent drug sustained-release control system for monitoring the vaginal environment disclosed in the embodiment of the present invention only discloses a preferred embodiment of the present invention, which is only used to illustrate the technical solution of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, a person of ordinary skill in the art should understand that the technical solutions described in the aforementioned embodiments can still be modified, or some of the technical features therein can be replaced by equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the various embodiments of the present invention.

Claims

1. A drug sustained-release control system for intelligently monitoring vaginal environment, characterized in that: The system comprises: A data monitoring device, disposed in the vaginal area of ​​the target user, for acquiring sensor data of the vaginal area; A data processing device, connected to the data monitoring device, for determining a drug release instruction corresponding to the target user based on the sensor data; A drug sustained-release device stores therapeutic drugs, is disposed in the vaginal area, and is connected to the data processing device, and is used to release the therapeutic drugs into the vaginal area according to the drug release instruction to treat the target user.

2. The drug sustained-release control system for intelligently monitoring vaginal environment according to claim 1, characterized in that: The data monitoring device includes a pH sensor, a temperature sensor, a humidity sensor and a data transmission module; the pH sensor, the temperature sensor and the humidity sensor are all connected to the data transmission module; the data transmission module transmits the sensing data acquired by the pH sensor, the temperature sensor and the humidity sensor to the data processing device based on Bluetooth technology.

3. The drug sustained-release control system for intelligently monitoring vaginal environment according to claim 2, characterized in that: The sensor data includes pH value data, temperature data and humidity data; the data processing device includes: A data correction module, used for mutually correcting any two pieces of the sensing data according to a data verification rule to obtain corrected sensing data; A flora prediction module, used for inputting the pH value data in the corrected sensor data into the trained flora prediction neural network to obtain an output flora abnormality degree value; An inflammation prediction module, used for inputting the temperature data in the corrected sensor data into a trained inflammation prediction neural network to obtain an output abnormal degree value of inflammation; A secretion prediction module, used for inputting the humidity data in the corrected sensor data into the trained secretion prediction neural network to obtain an output secretion abnormality degree value; The comprehensive analysis module is used to determine the drug release instruction corresponding to the target user according to the abnormal flora degree value, the abnormal inflammation degree value and the abnormal secretion degree value.

4. The drug sustained-release control system for intelligently monitoring vaginal environment according to claim 3, characterized in that: The specific method in which the comprehensive analysis module determines the drug release instruction corresponding to the target user includes: Determine whether any one of the abnormal flora value, the abnormal inflammation value, and the abnormal secretion value is within a corresponding abnormal value interval to obtain a first determination result; If the first judgment result is no, determining that the drug release instruction is an instruction that does not require release; If the first judgment result is yes, the abnormal flora value, the abnormal inflammation value or the abnormal secretion value within the abnormal value interval is determined as current abnormal data; Acquire historical abnormal data of the target user at at least one historical time point of the same data type as the current abnormal data; The drug release instruction corresponding to the target user is determined according to the current abnormal data and the historical abnormal data.

5. The drug sustained-release control system for intelligently monitoring vaginal environment according to claim 4, characterized in that: The specific manner in which the comprehensive analysis module determines the drug release instruction corresponding to the target user according to the current abnormal data and the historical abnormal data includes: Calculating a data difference between the current abnormal data and the historical abnormal data; Calculating the time difference between the data acquisition time point corresponding to the current abnormal data and the historical time point corresponding to the historical abnormal data; Calculate the ratio of the data difference to the time difference to obtain an abnormal change parameter; the abnormal change parameter retains positive and negative values; Determine whether the abnormal change parameters corresponding to the target user at multiple time points meet the preset abnormal mitigation data rules to obtain a second determination result; If the second judgment result is yes, generating a drug release amount parameter inversely proportional to the absolute value of the abnormal change parameter; If the second judgment result is no, generating a drug release amount parameter that is proportional to the absolute value of the abnormal change parameter; A drug release instruction corresponding to the target user is generated according to the drug release amount parameter; the drug release instruction is used to instruct the drug release device to release the therapeutic drug with a measured value corresponding to the drug release amount parameter.

6. The drug sustained-release control system for intelligently monitoring vaginal environment according to claim 2, characterized in that: The data transmission module comprises: A power management unit, used to manage and monitor the capacity of the power supply of the drug sustained-release control system; An encryption unit, used for encrypting the sensor data to obtain encrypted data; A Bluetooth transmission unit is used to transmit the encrypted data to the data processing device based on Bluetooth technology.

7. The drug sustained-release control system for intelligently monitoring vaginal environment according to claim 6, characterized in that: The specific method in which the encryption unit encrypts the sensor data to obtain encrypted data includes: Generate a first key based on a true random number generator and generate a certificate corresponding to the first key; Acquire sensor data of the target user at a previous historical time point, and generate a second key based on the sensor data at the previous historical time point and a preset data mapping rule; Based on a preset data vector calculation rule, generating an encryption key according to the first key and the second key; Encrypting the sensor data according to the encryption key to obtain encrypted data; The Bluetooth transmission unit transmits the encrypted data and the certificate to the data processing device; the data processing device decrypts the encrypted data based on the certificate and the sensor data at the previous historical time point to obtain the sensor data.

8. The drug sustained-release control system for intelligently monitoring vaginal environment according to claim 1, characterized in that: The drug sustained-release device comprises: shell; Three mutually independent drug storage areas are arranged in the shell, respectively storing antibacterial drugs, clotrimazole and nanosilver; A drug controlled release layer is disposed between the drug storage area and the shell; the drug controlled release layer is used to receive the drug release command to release the therapeutic drug.

9. The drug sustained-release control system for intelligently monitoring vaginal environment according to claim 8, characterized in that: The drug controlled release layer includes a first layer, a second layer and a third layer arranged from the drug storage area to the shell; the first layer is made of polyvinyl alcohol hydrogel material and is a response layer with a thickness of 200 microns. The first layer maintains a semi-expanded state under the normal human body temperature of 37°C to maintain the basic drug release rate. When the temperature of the local tissue rises to more than 38°C due to inflammation, the hydrogel network structure of the first layer will further expand to promote drug release; the first layer has a sensitive response characteristic to external electric field stimulation, and the hydrogel layer of the first layer can be induced to undergo controllable deformation by applying a weak electric field of 3-5V: the second layer is made of The polyacrylate copolymer material has a thickness of 150 microns, and the second layer has a unique pH response mechanism; when the local environmental pH value rises above 4.5, the carboxyl groups in the second layer material will undergo ionization, causing the network structure to expand significantly, triggering the rapid release of clotrimazole; the built-in microelectrode array of the second layer receives the electrical signal of the drug release command from the data processing device, and realizes dynamic regulation of the second layer network structure to control the amount of drug released; the third layer uses PDMS material with a thickness of 100 microns, and pH sensitive groups are introduced through surface modification technology, which has environmental responsiveness and selective permeability characteristics.

10. The drug sustained-release control system for intelligently monitoring vaginal environment according to claim 8, characterized in that: The shell is made of medical grade silicone material; the outer wall of the drug storage area is provided with a drug diffusion channel with a micropore array structure, the micropore diameter is 100-200 microns, the pore spacing is 500 microns, and it is staggered at a 45-degree angle for controlling drug release.

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