Physiological index monitoring and drug delivery integrated system and wearable application thereof

Abstract

The invention discloses a physiological index monitoring and drug delivery integrated system and an application thereof in wearable equipment, through integration of a microneedle array, a fluid chamber area, a piezoelectric sensing module, a drug controlled release module and a signal processing module, real-time monitoring of physiological indexes and automatic drug delivery are realized by using a double-chamber structure. The fluid chamber area is composed of a first fluid chamber and a second fluid chamber, the first fluid chamber and the second fluid chamber guide the flowing direction of a body fluid sample and medicine in a one-way mode through a microfluid channel and a one-way valve, and the first chamber is used for receiving and guiding the body fluid sample to the piezoelectric sensing module for physiological detection. The second chamber guides the medicine to the microneedle array for accurate delivery to realize real-time monitoring of physiological indexes and automatic medicine delivery, the piezoelectric sensing module guides a body fluid sample to the sensing unit and detects physiological parameters based on the acoustic surface wave effect, and the signal processing module controls the dosage of the medicine according to the detection result. And precise drug release is realized through the drug controlled release module.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of biomedical micro-electro-mechanical system manufacturing technology, and particularly relates to a physiological index monitoring and drug delivery integrated system and a wearable application thereof. BACKGROUND

[0002] With the increasing number of chronic diseases worldwide, especially metabolic diseases, endocrine diseases and other acute diseases, biomolecular monitoring and intelligent drug delivery technology is becoming an indispensable research field in modern medicine. These technologies provide real-time feedback for disease management and treatment by detecting biomarkers (such as glucose, lactate, cytokines, hormones, etc.) in the body in real time. At the same time, systems that automatically adjust drug delivery based on these detection results are gradually becoming an important direction of precision medicine. Although significant progress has been made in this field, most current applications still face many challenges in miniaturization, monitoring accuracy, real-time feedback control, and user comfort.

[0003] Traditional biomolecular monitoring methods rely on invasive sampling, such as finger prick blood glucose testing. These methods not only cause pain and inconvenience, but also can only provide intermittent physiological indicator data, making it difficult to achieve real-time and continuous monitoring and meet the needs of chronic disease patients for precise management. For example, with the advent of continuous glucose monitoring (CGM) devices, users can achieve continuous blood glucose monitoring to some extent. However, the limitations of these devices are still evident, mainly in that they can only monitor blood glucose, lack automatic treatment functions, and often use bulky adhesive devices that are inconvenient to wear and can cause skin irritation. More importantly, most devices rely on interstitial fluid (ISF) measurements, which cause delays in monitoring results and cannot accurately reflect the dynamic changes in blood glucose, thereby affecting the real-time and accuracy of treatment.

[0004] In addition, drug delivery systems such as insulin pumps can provide continuous drug delivery, but they are usually separate from monitoring devices and cannot achieve true closed-loop control, which means that drug delivery relies on single monitoring data and lacks the ability to automatically adjust based on real-time monitoring results. Many drug delivery devices are generally large in size, have external tubing or patches, and are inconvenient for patients to wear, resulting in poor user comfort. Moreover, these devices cannot effectively integrate monitoring and drug delivery functions, still requiring manual adjustment by patients, increasing the complexity and likelihood of errors in treatment.

[0005] While some research prototypes and early products have attempted to integrate biomolecular monitoring with drug delivery systems to form closed-loop systems, such as artificial pancreas, these systems generally suffer from problems such as excessive size, lack of integration, and poor comfort. Some products on the market, while attempting to miniaturize these functions, have still failed to achieve seamless integration with daily life, and their level of intelligence is low, unable to dynamically adjust and provide precise treatment based on the patient's real-time physiological data. This means that existing systems have not fully met patients' needs for convenient, accurate, and automated treatment in practical applications.

[0006] In summary, current technologies still lag significantly behind in continuous biomolecular monitoring, automated drug delivery, and system integration. Most existing devices still rely on traditional distributed designs, making it difficult to achieve integrated biomolecular monitoring and drug delivery within a small, wearable device. With technological advancements, there is an urgent need for a new type of system that can integrate biomolecular monitoring, drug delivery, and intelligent control into a small, convenient, wearable device, meeting patients' needs for convenience, comfort, precision treatment, and intelligent monitoring. Summary of the Invention

[0007] Based on this, the present invention aims to propose an integrated system for physiological indicator monitoring and drug delivery and its wearable application, which integrates an independent fluid chamber and a piezoelectric biosensor module with microfluidic capabilities to achieve the integration and miniaturization of physiological indicator monitoring and drug delivery, and to achieve precise controlled release of drugs through microfluidics.

[0008] In a first aspect, the present invention provides an integrated system for monitoring physiological indicators and delivering drugs, including a microneedle array, a fluid chamber region, a piezoelectric sensing module, a drug controlled release module, a drug storage module, and a signal processing module;

[0009] The fluid chamber region includes a first fluid chamber and a second fluid chamber that are isolated from each other by fluid paths. The first fluid chamber is used to receive and unidirectionally guide the body fluid sample obtained by the microneedle array to the piezoelectric sensing module. The second fluid chamber is connected to the drug controlled release module and is used to unidirectionally guide the drug released from the drug storage module to the drug controlled release module to the microneedle array to complete the drug delivery.

[0010] The piezoelectric sensing module is connected to the first fluid chamber and includes a microfluidic channel and a piezoelectric detection unit. It is used to guide the body fluid sample in the microfluidic channel to the piezoelectric detection unit in the direction of the surface acoustic wave effect, and transmit the output signal to the signal processing module.

[0011] The signal processing module is communicatively connected to the piezoelectric sensing module and the drug storage module, respectively. It is used to calculate the physiological index monitoring results based on the output signal of the piezoelectric sensing module, calculate the drug delivery dose based on the physiological index monitoring results, and control the drug storage module to release the drug to the drug controlled release module based on the calculated drug delivery dose.

[0012] Furthermore, the first fluid chamber and the second fluid chamber are disposed on the same chamber layer surface, and an isolation component is provided at the junction of the first fluid chamber and the second fluid chamber for physical isolation of the two fluid chambers.

[0013] Furthermore, the piezoelectric detection unit includes a sensing layer and a biometric element fixed to the surface of the sensing layer. The biometric element is used to bind with target biomolecules in the body fluid sample to generate reaction products with electron donation and acceptance capabilities. The reaction products undergo charge transfer in the sensing layer, thereby causing a change in the output signal of the piezoelectric detection unit.

[0014] Furthermore, the piezoelectric detection unit includes a first acoustic transducer layer and a second acoustic transducer layer;

[0015] Both the first and second acoustic transducer layers utilize surface acoustic waves for fluid control. The first acoustic transducer layer controls the body fluid sample to flow directionally to the piezoelectric detection unit through a microfluidic channel. The second acoustic transducer layer controls the remaining portion of the body fluid sample that is not guided to the piezoelectric detection unit to flow directionally to the second fluid chamber through the microfluidic channel, so that it is unidirectionally guided to the microneedle array through the second fluid chamber.

[0016] Furthermore, the drug controlled-release module includes an acoustic transducer layer, a measurement area, and a controlled-release area;

[0017] The acoustic transducer layer uses surface acoustic waves to control the directional flow of the drug to the measurement zone for dosage determination, and controls the directional flow of the drug after dosage determination in the measurement zone to the controlled release zone, so that the drug enters the second fluid chamber through the controlled release zone.

[0018] Furthermore, the acoustic transducer layer of the drug controlled release module includes a third acoustic transducer layer and a fourth acoustic transducer layer;

[0019] The third acoustic transducer layer is used to control the directional flow of the drug to the measurement area for dose determination, and the fourth acoustic transducer layer is used to control the directional flow of the drug after dose determination in the measurement area to the controlled release area.

[0020] Furthermore, the piezoelectric sensing module and the drug controlled release module are disposed on the same piezoelectric layer surface and are not stacked on each other in a plane.

[0021] Furthermore, microfluidic channels are formed on the surface of the piezoelectric layer by etching.

[0022] Furthermore, the microfluidic channel of the piezoelectric sensing module is equipped with a first flow direction control unit for directional guidance of the body fluid sample.

[0023] Furthermore, the drug controlled release module is equipped with a second flow control unit for directional guidance of the drug.

[0024] Furthermore, the microneedles on the microneedle array are provided with side holes.

[0025] Furthermore, an isolation layer is provided on the surface of the microneedle array that comes into contact with the external biological environment to provide physical isolation between the microneedle array and the external biological environment.

[0026] Furthermore, the sensing layer of the piezoelectric detection unit includes graphene material or two-dimensional semiconductor material.

[0027] Furthermore, the drug storage module includes a drug storage unit and a temperature control unit;

[0028] The drug storage unit is connected to the second fluid chamber and is used to release the drug into the drug controlled release module. The temperature control unit is used to control the drug temperature in the drug storage unit within a preset temperature range.

[0029] Furthermore, the temperature control unit includes a phase change material or a Peltier element.

[0030] Furthermore, the system also includes a product absorption element for absorbing byproducts generated when the biorecognition element binds to target biomolecules in a body fluid sample.

[0031] Secondly, the present invention provides a wearable application of the above-mentioned integrated system for monitoring physiological indicators and delivering drugs.

[0032] Furthermore, the wearable application mentioned above includes a wearable component, on which a flexible pressure sensing module is provided. The flexible pressure sensing module is communicatively connected to the signal processing module in the above system and is used to monitor physiological indicators including at least one of blood pressure, pulse, and heart rate.

[0033] As can be seen from the above technical solution, the present invention has the following beneficial effects:

[0034] This invention provides an integrated system for physiological indicator monitoring and drug delivery, and its wearable application. It innovatively combines physiological indicator monitoring and drug delivery functions through a dual-fluid chamber structure and microfluidics. The first and second fluid chambers of the system are effectively separated by physical isolation, ensuring independent flow of body fluid samples and drug fluids, thereby avoiding cross-contamination and mutual interference. This design not only solves the contradiction between monitoring and drug delivery in traditional devices but also ensures the parallel operation of both functions. The first fluid chamber is specifically used to guide body fluid samples into the piezoelectric sensing module for biomolecular detection, while the second fluid chamber is used to guide drugs to the microneedle array for precise drug delivery, ensuring that the monitoring and drug delivery processes are undisturbed, independent, and efficient. The integrated design of this invention achieves closed-loop control, organically combining real-time monitoring of physiological indicators with precise regulation of drug delivery. When the piezoelectric sensing module outputs a signal based on the detection results of the body fluid sample, the signal processing module analyzes the data, calculates the precise drug delivery dose, and then controls the drug storage based on the calculation results. The drug release from the storage module achieves precise drug delivery. This closed-loop control mechanism dynamically adjusts the drug dosage based on real-time physiological status, avoiding overdose or underdose problems in traditional drug delivery methods, thereby maximizing therapeutic effect and reducing side effects. This invention employs a piezoelectric sensing module based on the surface acoustic wave (SAW) effect. A microfluidic channel precisely guides the body fluid sample to the piezoelectric detection unit. Furthermore, the biometric element of the detection unit binds to target biomolecules in the body fluid sample, causing charge transfer and generating significant signal changes, achieving high-sensitivity detection. Due to the application of SAW technology, the system can accurately measure even small body fluid samples, improving its application value in small-volume and high-sensitivity environments. In a further embodiment, during drug release, an acoustic transducer layer controls the drug flow to the measurement area for dosage determination, and guides the drug through the measurement area to the controlled-release area, achieving effective drug release. Surface acoustic waves control fluid flow, ensuring precise drug guidance and dosage control, further improving the accuracy of drug delivery.This technology solves common problems in traditional drug delivery systems, such as drug waste and dosage instability, making the drug release process more efficient and reliable. A further embodiment includes a temperature control unit to ensure the drug remains within an ideal temperature range during storage and release, preventing drug failure at high or low temperatures. This function can be achieved using phase change materials or Peltier elements to achieve precise temperature control, ensuring drug efficacy and therapeutic stability. The system also includes a product absorption element to absorb byproducts generated when the biorecognition element binds to the target biomolecule, further extending the lifespan of the biosensor and improving the long-term stability and reliability of the system. In wearable applications, this invention integrates key components (such as microneedle arrays, piezoelectric sensing modules, and drug controlled-release modules) into a compact wearable device, ensuring that the device is both convenient and comfortable in daily use. The device adopts a flexible design, which can easily adapt to different user activity scenarios and is suitable for long-term wear. A further embodiment integrates a force-sensitive sensing module into the wearable application to achieve integrated monitoring of multiple physiological indicators. The system and its application provided by this invention enable users to understand their own health status without complicated operations and to adjust medication based on real-time monitoring results, greatly enhancing the application value of wearable medical devices in health monitoring and personalized drug delivery. Attached Figure Description

[0035] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0036] Figure 1 This is a schematic diagram of the fluid chamber region structure provided in an embodiment of the present invention;

[0037] Figure 2 This is a schematic diagram of the structure of the piezoelectric sensing module and the drug controlled release module provided in the embodiments of the present invention;

[0038] Figure 3 This is a schematic diagram of the microneedle array structure provided in an embodiment of the present invention;

[0039] Figure 4 This is a schematic diagram of the structure of the drug storage module and signal processing module provided in an embodiment of the present invention;

[0040] Figure 5 A schematic diagram illustrating the wearable application of the integrated physiological indicator monitoring and drug delivery system provided in this embodiment of the invention;

[0041] Figure 6This is a schematic diagram of a microneedle array used in a wearable application as shown in Figure 5.

[0042] Figure 7 This is a schematic diagram illustrating the inflow and outflow of interstitial fluid samples through a microneedle array in the fluid chamber region, as provided in an embodiment of the present invention. Detailed Implementation

[0043] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0044] The embodiments provided below will describe in detail the implementation and application of the integrated physiological indicator monitoring and drug delivery system provided by the present invention, in conjunction with specific technical solutions and structural designs. This includes the independent structure of the fluid chamber, the high-sensitivity detection of the piezoelectric sensing module, the precise control of the drug controlled release module, and the implementation of the closed-loop control mechanism. The embodiments will also demonstrate how to integrate real-time physiological monitoring and automatic drug delivery in wearable applications.

[0045] One embodiment of the present invention provides an integrated system for monitoring physiological indicators and delivering drugs, including a microneedle array, a fluid chamber region, a piezoelectric sensing module, a drug controlled release module, a drug storage module, and a signal processing module.

[0046] The fluid chamber region includes a first fluid chamber and a second fluid chamber that are isolated from each other by fluid paths. The first fluid chamber is used to receive and unidirectionally guide the body fluid sample obtained by the microneedle array to the piezoelectric sensing module. The second fluid chamber is connected to the drug controlled release module and is used to unidirectionally guide the drug released from the drug storage module to the drug controlled release module to the microneedle array to complete the drug delivery.

[0047] The piezoelectric sensing module is connected to the first fluid chamber and includes a microfluidic channel and a piezoelectric detection unit. It is used to guide the body fluid sample in the microfluidic channel to the piezoelectric detection unit in a directional manner using the surface acoustic wave effect, and transmit the output signal to the signal processing module.

[0048] The signal processing module is communicatively connected to the piezoelectric sensing module and the drug storage module, respectively. It is used to calculate the physiological index monitoring results based on the output signal of the piezoelectric sensing module, calculate the drug delivery dose based on the physiological index monitoring results, and control the drug storage module to release the drug to the drug controlled release module based on the calculated drug delivery dose.

[0049] (1) Fluid chamber region

[0050] The fluid chamber region provided in this embodiment of the invention is responsible for receiving and guiding body fluid samples and unidirectional delivery of drugs. Specifically, it includes independent fluid chambers, namely a first fluid chamber and a second fluid chamber, which are used to guide the independent flow of body fluid samples and drugs, avoiding cross-contamination or unnecessary mutual interference.

[0051] Specifically, the fluid chamber region includes at least two independent chambers, each used for different functions of fluid guidance and processing. The first fluid chamber receives bodily fluid samples (such as blood, interstitial fluid, etc.) collected from the skin or other biological tissues by the microneedle array. The samples are guided sequentially to the piezoelectric sensing module for physiological indicator analysis. The design of the first fluid chamber ensures unidirectional fluid flow, preventing leakage or contamination of the samples. The second chamber guides drugs (such as insulin) to the microneedle array, ensuring a completely closed and independent drug delivery path from the drug storage module to the drug controlled-release module. After being released from the drug storage module to the drug controlled-release module, the drug is further guided into the second fluid chamber and ultimately precisely delivered to the external biological tissue via the microneedle array. The disconnected fluid paths of the two chambers ensure precise control of the drug delivery process, preventing drug leakage or dosage control errors.

[0052] In a further embodiment, two fluid chambers are disposed on the same chamber layer surface, and an isolation component is provided at the junction of the chambers to ensure the independence of their respective fluid paths and avoid cross-contamination or misdirection. The isolation component can be designed using methods such as micro-isolation walls or adhesive materials to ensure that the fluids in the chambers do not cross-contaminate and that the fluid paths in each chamber are completely independent.

[0053] The fluid in the first fluid chamber is guided from the external biological environment into the system and further to the piezoelectric sensing module. The fluid in the second fluid chamber is guided from inside the device to deliver the drug to the microneedle array.

[0054] It is worth mentioning that, in order to ensure the smooth flow of body fluid samples and prevent body fluids (especially blood) from clotting in the system, the remaining portion of unused body fluid samples will be returned to the biological tissue through the second fluid chamber. This design not only ensures the continuous flow of body fluid samples, but also effectively avoids the blood clotting or blockage problems that may be caused by body fluid samples stagnating in the system.

[0055] Specifically, after a body fluid sample enters the first fluid chamber and is monitored by the piezoelectric sensing module, the portion of body fluid not yet collected by the sensor will be guided into the biological tissue through the reflux path of the second fluid chamber. To ensure smooth flow of body fluid, the second fluid chamber can promote the reflux process by designing a reasonable fluid path and a precise flow direction control unit, utilizing appropriate pressure differences or fluid dynamics principles.

[0056] In one specific embodiment, the material for the fluid chamber region can be biocompatible PDMS (polydimethylsiloxane). This material has good transparency, allowing for easy observation of the fluid flow process, while also possessing strong flexibility and processability, making it suitable for matching the design requirements of microfluidic channels and microfluidic components. Furthermore, to improve the system's sealing performance, the fluid chamber region can also employ advanced processes such as thermoforming or laser welding to ensure complete sealing of the fluid path, thereby avoiding the risk of leakage or contamination.

[0057] Furthermore, in this embodiment of the invention, the fluid chamber region can integrate multiple functional modules into the same microstructure using advanced micromachining technology (MEMS), thereby achieving a high degree of system integration. This not only saves device size but also improves the overall system stability and reliability. In terms of packaging design, adjustable pressure microsensors can be used to monitor pressure changes within the fluid chamber, thereby further ensuring smooth fluid flow and preventing system failures caused by excessive or insufficient pressure.

[0058] For example, Figure 1 This illustrates one implementation of the fluid chamber region. Figure 1 The fluid chamber region 100 shown in the diagram is a chamber layer made of PDMS material, which encloses two adjacent but non-connected fluid chambers, including a first fluid chamber 101 and a second fluid chamber 102. The junction of the two fluid chambers is a micro-isolation wall 103 formed of PDMS material, which ensures the high degree of independence of the fluids during the flow process, so that the two fluids do not cross each other during the flow process and each flows along a predetermined path.

[0059] The first fluid chamber 101 is provided with a first communication hole 104 that communicates with the piezoelectric sensing module, for guiding the body fluid sample entering the first fluid chamber to the piezoelectric sensing module; the second fluid chamber 102 is provided with a second communication hole 105 that communicates with the drug controlled release module, for guiding the drug or unused body fluid sample to flow through the microneedle array to the biological tissue.

[0060] In a more preferred embodiment, the surface of the chamber layer may also undergo special treatment, such as an anti-coagulation coating or hydrophilic modification, to further enhance biocompatibility and prevent contamination by bodily fluid samples and drugs. Through these surface treatments, it is ensured that no adverse reaction occurs at the interface between the fluid and the chamber layer, thereby improving the long-term stability of the system.

[0061] (2) Piezoelectric sensing module

[0062] The piezoelectric sensing module provided in this embodiment of the invention utilizes the properties of piezoelectric materials to generate surface acoustic waves, thereby guiding the body fluid sample in a direction through a microfluidic channel to the piezoelectric detection unit and transmitting the output signal to the signal processing module.

[0063] Specifically, the piezoelectric detection unit includes a sensing layer and a biometric element fixed on the surface of the sensing layer. The biometric element is used to bind with target biomolecules in the body fluid sample to generate reaction products with electron donation and acceptance capabilities. The reaction products undergo charge transfer in the sensing layer, thereby causing a change in the output signal of the piezoelectric detection unit.

[0064] After a biometric element binds to a target biomolecule, a specific reaction needs to occur to produce reaction products with electron donation and acceptance capabilities, such as hydrogen peroxide (H2O2), metal ions, charged metabolites, nitrogen oxides, etc. Utilizing the sensing layer's extreme sensitivity to electron injection and removal, changes in the sensing layer's field effect or conductivity are read as electrical signals, thereby reflecting the target biomolecule and its concentration changes through the output signal.

[0065] Microfluidic channels are used to guide body fluid samples to the piezoelectric detection unit and ensure smooth flow of body fluid within the channel. The size and shape of the microfluidic channel are precisely designed to adapt to the flow requirements of different body fluid samples and can effectively guide the sample through flow control elements (such as one-way valves).

[0066] In a further embodiment, the piezoelectric detection unit includes a first acoustic transducer layer and a second acoustic transducer layer. The first acoustic transducer layer controls the directional flow of the body fluid sample to the sensing layer through a microfluidic channel, while the second acoustic transducer layer is responsible for controlling the remaining part of the sample that is not guided to the piezoelectric detection unit, guiding it to the second fluid chamber through the microfluidic channel, and allowing it to flow back to the biological tissue through the fluid path of the second fluid chamber.

[0067] In some embodiments, the piezoelectric detection unit employs graphene as the sensing layer material. Graphene is widely used in the field of biosensors due to its excellent conductivity, high specific surface area, and biocompatibility. Specifically, the graphene layer is fixed to the surface of the piezoelectric layer. When the biorecognition element on the surface binds to the target biomolecule in the body fluid sample, the resulting charge transfer causes a change in the conductivity of the graphene layer, ultimately leading to a change in the output electrical signal. Because of graphene's excellent conductivity, it can effectively improve the sensitivity of the sensor, thereby achieving high-precision monitoring of low concentrations of biomolecules.

[0068] In another embodiment, the piezoelectric detection unit uses a two-dimensional semiconductor material, such as molybdenum disulfide (MoS2), as the sensing layer. Two-dimensional semiconductor materials have excellent electronic properties and can be combined with piezoelectric materials through simple processing technology to further improve the sensitivity and response speed of the sensing module.

[0069] To ensure accurate guidance of bodily fluid samples, a first flow direction control unit is installed within the microfluidic channel of the piezoelectric sensing module. This unit controls the sample flow direction based on fluid dynamics principles. Through microfluidic technology, bodily fluid samples can be accurately guided to the piezoelectric detection unit for analysis. Furthermore, the flow direction control within the microfluidic channel can dynamically adjust the fluid flow direction based on real-time changes in flow rate and pressure, ensuring that sample detection is unaffected by external disturbances.

[0070] (3) Drug controlled release module

[0071] The main function of the drug controlled-release module is to precisely control the amount of drug released based on the physiological data output by the piezoelectric sensing module and deliver the drug to the target site. Precise fluid control enables accurate control of drug flow and ensures strict control over drug release time and dosage, thereby achieving personalized and precise therapeutic effects.

[0072] Specifically, the drug controlled-release module includes an acoustic transducer layer, a measurement zone, and a controlled-release zone. The acoustic transducer layer uses surface acoustic waves to control the directional flow of the drug to the measurement zone for dosage determination, and controls the directional flow of the drug after dosage determination in the measurement zone to the controlled-release zone, so that the drug enters the second fluid chamber through the controlled-release zone.

[0073] The acoustic transducer layer is the core component of the drug controlled-release module. It regulates the flow path and velocity of the drug through the surface acoustic wave (SAW) effect, specifically by generating SAW waves in the drug channel to propel the drug flow. The SAW waves drive the drug fluid along a predetermined path. In the drug controlled-release module, the acoustic transducer layer controls the speed and direction of drug flow based on signals from the piezoelectric sensing module, ensuring that the drug is released at a precise dosage.

[0074] In one specific embodiment, the drug-controlled release module employs a dual-transducer layer design. One layer controls the drug flow to the measurement zone for dosage determination, while the other guides the dosage-determined drug to the controlled-release zone, thus completing the drug delivery process. Surface acoustic wave (SAW) technology precisely controls the drug flow into the measurement zone, where the drug flow rate, velocity, and concentration are measured. This measurement process ensures that the drug has undergone sufficient dosage confirmation before being delivered to the controlled-release zone. Simultaneously, SAW is used to directionally guide the drug to the controlled-release zone, where it is precisely controlled to ensure that it is injected into biological tissue at the correct dose and flow rate under the propulsion of the microneedle array. Through the dual-transducer layer design, this invention ensures precise drug control and delivery, avoiding the over- or under-dosage issues that may occur in traditional drug delivery systems.

[0075] In a further embodiment, the drug controlled release module also guides the flow of the drug more precisely through a microfluidic channel, and a second flow control unit, such as a micro pump or a one-way valve, is configured in the channel to further ensure precise control of the drug flow direction and dosage.

[0076] In a further embodiment, the piezoelectric sensing module and the drug controlled release module are integrated on the same piezoelectric layer surface, ensuring high integration and compactness of the system. By integrating the microfluidic channel, piezoelectric detection module, and drug controlled release module on the same piezoelectric layer surface, errors from multiple signal conversions are reduced, the overall response speed is improved, and the system manufacturing process is simplified.

[0077] For example, Figure 2 One implementation is illustrated, specifically showing that the piezoelectric sensing module 201 and the drug controlled release module 202 are integrated on the same piezoelectric layer 203 surface, and the two are not stacked on the plane to achieve a compact structural design.

[0078] The piezoelectric sensing module 201 includes acoustic transducer electrodes 2011-2012 and a first microfluidic channel 2013. The first microfluidic channel 2013 is equipped with a first one-way valve group 2014 and is connected to the first fluid chamber through the sample introduction area 2015. Figure 2 Specifically, a microfluidic channel with multiple branch structures is illustrated. At the end of each channel branch, a sensing unit 2016 is provided. The sensing unit 2016 includes a sensing layer and a biometric element fixed on the surface of the sensing layer, so that the body fluid sample enters each sensing unit through each channel branch and combines with the biometric element to generate a reaction product with electron donation and acceptance capabilities.

[0079] Its working process is as follows:

[0080] Body fluid samples enter the first microfluidic channel 2013 through the sample introduction area 2015. During flow, the first one-way valve group 2014 configured in the first microfluidic channel 2013 ensures that the body fluid sample can only flow in a predetermined direction, preventing backflow and thus avoiding cross-contamination or incorrect flow direction during the flow process, ensuring that the flow direction of the sample meets the detection requirements. During the flow of body fluid samples in the first microfluidic channel 2013, the first acoustic transducer 2011 and the second acoustic transducer 2012 work together. The first acoustic transducer 2011 uses the surface acoustic wave effect to guide the sample directionally through the microfluidic channel to each sensing unit 2016, while the second acoustic transducer 2012 coordinates the flow of the sample in the channel, ensuring that the remaining sample that is not guided to the sensing unit can flow smoothly through the microfluidic channel to the second flow chamber, avoiding sample retention in the system and ensuring the high efficiency of fluid flow.

[0081] The drug controlled release module 202 includes acoustic transducer electrodes 2021-2023, a drug introduction area 2024, a drug measurement area 2025, and a drug controlled release area 2026. The drug to be delivered is received by the drug storage module through the drug introduction area 2024. In order to guide the flow direction of the drug, a second microfluidic channel 2027 is also provided.

[0082] Its working process is as follows:

[0083] The drug storage module delivers the drug to the drug introduction area 2024, which serves as the starting point for drug flow, ensuring the drug can smoothly enter the drug controlled-release module and proceed to the control area of ​​the next step. The drug is then guided by the second microfluidic channel 2027 into the drug measurement area 2025, where its flow rate, concentration, and dosage are accurately measured. Specifically, the acoustic transducer electrode 2021 guides the drug to the first measurement area, the acoustic transducer electrode 2022 guides the drug to the second measurement area, and the acoustic transducer electrode 2023 guides the drug into the drug controlled-release area 2026. The drug is then guided to the microneedle array for delivery via the communication pathway between the drug controlled-release area 2026 and the second fluid chamber.

[0084] In a further embodiment, in order to improve the accuracy of drug dosage measurement, the number of measurement areas and acoustic transducers can be increased accordingly. By combining multiple acoustic transducers with multiple measurement areas, precise fluid control and dosage detection can be achieved during drug delivery. At each stage of drug flow, the acoustic transducers and measurement areas can work together precisely to adjust the drug flow rate, concentration and total dosage in real time, ensuring high accuracy and high reliability of the drug delivery process.

[0085] The first microfluidic channel 2013 and the second microfluidic channel 2027 are both formed on the surface of the piezoelectric layer 203 by etching. This design ensures the high precision and stability of the microfluidic channels through microfabrication technology. However, in a further embodiment, to further improve the system performance and the functionality of the microfluidic channels, more complex microfluidic structure design and manufacturing methods can be adopted.

[0086] In a further embodiment, the microfluidic channel can also employ a multi-layered structural design, forming multiple parallel or series-connected microfluidic channels at different levels. This design enables the integration of more functional areas, such as simultaneously processing different types of body fluid samples or drugs.

[0087] In a further embodiment, the width and shape of the microfluidic channels can be adjusted as needed. The geometry and size of each microfluidic channel can be precisely controlled by methods such as laser cutting or electrochemical etching to adapt to different fluid flow requirements.

[0088] Further optimization of microfluidic channels can be achieved by integrating temperature control elements or fluid resistance regulation elements, such as fluid regulating valves or adjustable channels, to realize more efficient fluid management. In this way, the flow characteristics of the microfluidic channel can be dynamically adjusted according to the different characteristics of the drug or body fluid sample, such as viscosity and flow rate, to ensure the stability and accuracy of fluid flow.

[0089] In a further embodiment, the microfluidic channel is not limited to the traditional two-dimensional planar design, but can also employ a three-dimensional structural design. Combined with MEMS (Micro-Electro-Mechanical Systems) technology, more complex fluid paths can be achieved through the three-dimensional structure. Three-dimensional microfluidic channels can utilize space more efficiently, provide more complex fluid manipulation and control, and further improve the system's integration and performance.

[0090] In a further embodiment of the invention, the system further includes a product absorption element designed to effectively absorb and process byproducts generated by the binding of the biorecognition element to target biomolecules in the body fluid sample. This design not only improves the stability and long-term feasibility of the system but also effectively avoids interference from byproducts to the sensing module, ensuring the long-term accuracy and performance of the biosensor.

[0091] To effectively absorb byproducts, the product absorption element typically employs materials with high adsorption properties, such as porous materials, polymer-based materials, and activated carbon. These materials can adsorb byproducts upon contact with bodily fluid samples and prevent them from flowing back into the sensing module or drug delivery module. In a further embodiment, the absorption material can also be selected with functionalized surfaces possessing specific affinities, tailored to the specific application requirements, to selectively adsorb specific types of byproduct molecules.

[0092] By regularly cleaning or replacing the adsorbent material in the product absorber, the accumulation of byproducts can be effectively prevented, ensuring the long-term stability and accuracy of the system. In some embodiments, the product absorber can also integrate monitoring functions to detect the adsorption capacity and efficiency of the adsorbent material in real time, ensuring that the absorption and treatment of byproducts are unrestricted and that timely maintenance measures are taken.

[0093] For example, by Figure 2 This diagram illustrates the implementation of byproduct recovery. Specifically, byproducts generated from the binding of the biometric element with the target biomolecule in the body fluid sample flow through the second microfluidic channel 2017 to the product absorption area 204. The product absorption area is equipped with a product absorbent, and the second microfluidic channel 2017 is equipped with a second one-way valve assembly 2018 to ensure that the byproducts can only flow in a predetermined direction and to prevent backflow or mixing with other fluids. Through this design, the byproducts are effectively guided to the product absorption area 204 without interfering with other parts of the system (such as the piezoelectric sensing module, drug controlled release module, etc.).

[0094] (4) Microneedle array

[0095] A microneedle array consists of multiple microneedles evenly arranged on an array surface at specific intervals and angles. The size of the microneedles typically ranges from several hundred micrometers to one millimeter to ensure penetration of skin or other biological tissues without causing excessive pain or damage. Each microneedle can be conical, cylindrical, needle-like, or other shapes, depending on the application requirements and the characteristics of the target tissue. The surface of the microneedles usually has high surface energy to increase the contact area with biological tissue, thereby facilitating sample collection and drug delivery.

[0096] In some embodiments, the needle is designed with side holes or micro-openings for collecting fluid samples (such as blood, interstitial fluid, etc.) that have seeped from biological tissues and for delivering drugs into the biological tissues. These micro-pores guide fluid into or out of the array through surface tension and capillary action.

[0097] In some designs, when the piezoelectric sensing module and the drug controlled-release module are integrated on the same piezoelectric layer surface, the system design of this invention can have the fluid chamber region covered above the piezoelectric layer, while the microneedle array is disposed above the fluid chamber region. In this case, the side holes on the microneedles can be designed to have different orientations. Specifically, the microneedle array is regarded as two sub-arrays. The one located directly above the first fluid chamber is denoted as the first sub-array, and the one located directly above the second fluid chamber is denoted as the second sub-array. The microneedle side holes of the first sub-array and the second sub-array have different orientations to further optimize the fluid path for sample collection and drug delivery, and to maximize the independence of the two, so that the two fluid paths do not interfere with each other as much as possible.

[0098] In a further embodiment, a special isolation layer is provided on the surface of the microneedle array on the side that contacts the biological tissue. This layer ensures that when the microneedles penetrate biological tissue (such as skin, subcutaneous tissue, etc.), the sample will not leak or become contaminated within the microneedle system. The isolation layer material can be a polymer film, silicone layer, hydrogel, flexible polymer, etc., possessing flexibility and elasticity, and capable of adapting to different deformations of skin or other biological tissues.

[0099] For example, Figure 3 The illustration shows one implementation of a microneedle array 300, which includes a plurality of uniformly distributed microneedles 301 and a hydrogel layer 302 covering its surface. When the microneedle array penetrates the surface of biological tissue to sample body fluids, it is isolated by the hydrogel layer 302.

[0100] Specifically, microneedles 301 are uniformly distributed on the array surface and spaced appropriately according to design requirements. The shape, size, and arrangement of the microneedles are adjusted according to actual application needs to ensure that they can penetrate biological tissues (such as skin or subcutaneous tissue) without causing excessive pain or damage. The hydrogel layer 302 provides appropriate cushioning during microneedle penetration, reducing irritation to the surface of biological tissues and preventing fluid leakage during sample collection or drug delivery. Furthermore, the hydrogel layer 302 can also form a closed, isolated environment between the microneedle array and the skin or biological tissue, ensuring the accuracy of sample collection and the independence of drug delivery.

[0101] (5) Drug storage module

[0102] The drug storage module may specifically include a drug storage unit and a temperature control unit, wherein the drug storage unit is used to release the drug into the drug controlled release module, and the temperature control unit is used to control the drug temperature in the drug storage unit within a preset temperature range.

[0103] Specifically, the drug storage unit is used to store drugs to be delivered. In this embodiment, the drug storage unit may be made of a material with good sealing properties to ensure that the drug is not affected by external factors (such as temperature, humidity, light, etc.) during storage, thereby maintaining the stability of the drug. The drug storage unit can prevent drug leakage through a sealing mechanism and has an easily controllable release port to facilitate the guidance and release of the drug.

[0104] The temperature control unit is in contact with or connected to the drug storage unit to regulate and control the storage temperature of the drug, so as to ensure that the drug is within a suitable temperature range during storage and prevent the drug from becoming ineffective due to high or low temperature environments. The role of the temperature control unit is particularly important for some heat-sensitive drugs.

[0105] In a preferred embodiment, the temperature control unit may employ technologies such as phase change materials and Peltier elements to effectively control the temperature of the drug based on the principle of heat conduction.

[0106] When drug delivery is required, the drug storage module releases the drug through the communication area with the drug controlled release module. The drug controlled release module then uses the surface acoustic wave effect or other control mechanisms to precisely guide the drug through the second fluid chamber to the microneedle array for delivery.

[0107] Furthermore, the drug storage unit is designed as a detachable structure, which facilitates quick removal when drug replacement or maintenance is required. Specifically, it can be connected to the main body of the drug storage module through snap-fit, spiral interface or sliding interface, which facilitates quick installation or replacement.

[0108] For example, Figure 4This illustration depicts an implementation of a compact structural design. The drug storage module 401 and signal processing module 402 are designed on the same material layer, which also integrates a product absorber 403. These three components are not stacked on a plane. The drug storage module 401 includes a drug cartridge 4011, a Peltier temperature control element 4012, and a drug release area 4013. Combined with... Figure 2 Looking at it, drug release zone 4013 is... Figure 2 The drug introduction area 2024 is connected. After the drug is released from the drug box 4011, it enters the drug introduction area 2024 through the drug release area 4013, and then enters the drug controlled release module 202. The product absorber 403 is placed in a position corresponding to the product absorption area 204, so that byproducts are absorbed by the product absorber 403 through the product absorption area 204.

[0109] The integrated design of the drug storage module 401, signal processing module 402 and product absorption device 403 effectively reduces the system size and weight by sharing material layers or the same manufacturing process, improving the portability of the equipment. By arranging each module in a planar manner, the space waste caused by module stacking is avoided, making the whole system more compact.

[0110] The integrated systems described in the above embodiments can be automated and mass-produced using existing MEMS processing platforms, possessing excellent process stability and yield control capabilities. They are easy to integrate into existing health management infrastructures such as medical testing or wearable device applications. At the same time, this manufacturing path has good adaptability to the existing industrial chain, which helps to achieve low-cost, large-scale mass production of devices in medical, diagnostic, and biological monitoring scenarios.

[0111] Another embodiment of the present invention provides an application of the integrated system described in the above embodiments in a wearable device. Such a wearable application can be implemented in various forms depending on specific needs and implementation environments. Specifically, these wearable devices can be watches, wristbands, armbands, chest straps, belts, or other wearable items, and the device can be worn on any suitable part of the human body, such as the wrist, arm, chest, abdomen, ankle, or head. Furthermore, wearable devices can be designed with adjustable structures to adapt to different life scenarios and individual needs, such as adjustable-size wristbands, elastically adjustable patches, or embedded devices.

[0112] Such wearable applications can be designed with flexible, lightweight, and breathable materials to ensure user comfort and long-term convenience. The various functional modules within the device can be integrated into a compact modular system according to design requirements, or combined through detachable modules to improve flexibility and adaptability.

[0113] Furthermore, the wearable device applications mentioned in the embodiments of this invention can interact with mobile terminals, cloud platforms, or medical devices via wireless communication technologies (such as Bluetooth, Wi-Fi, etc.), supporting real-time monitoring, remote diagnosis, and the development of personalized treatment plans. Wearable applications can, according to specific needs, combine multiple physiological parameters such as pressure sensing, temperature sensing, motion monitoring, blood glucose monitoring, heart rate monitoring, and oxygen saturation monitoring to provide comprehensive health data support, and can automatically adjust drug dosages or deliver necessary medications to achieve personalized health management and treatment.

[0114] In some preferred applications, the wearable device's casing incorporates a flexible pressure sensing module for real-time measurement of the wearer's physiological parameters, such as blood pressure, pulse, and heart rate. This pressure sensing module utilizes a pressure sensor array, which can sensitively detect pressure changes on the skin surface or blood vessel walls, accurately acquiring physiological signals. The pressure sensor array operates based on force-sensitive sensing (FSR) technology. When the wearable device comes into contact with the skin surface, the sensor array senses minute pressure changes and converts them into electrical signals, providing vital physiological information such as blood pressure, pulse, and heart rate.

[0115] To further illustrate the technical content of the present invention, the integrated system and its wearable application provided by the present invention will be described in detail below, taking blood glucose monitoring and insulin administration as examples.

[0116] like Figure 5 As shown, the wearable application of this invention takes a smart watch as an example. The watch's interactive interface is defined as the top, and the side of the watch that contacts the skin is defined as the bottom. From bottom to top, the device is arranged with a microneedle array 501, a fluid chamber region 502, a piezoelectric sensing layer 503, and a chip body layer 504. The fluid chamber region 502 has two chambers with mutually isolated fluid paths. The piezoelectric sensing layer integrates a piezoelectric sensing module and a drug controlled-release module that are not stacked on a plane. The chip body layer 504, in addition to housing a signal processing chip, also integrates a drug storage module and a byproduct absorption sponge. The microneedle array 501 is used to collect interstitial fluid through the skin surface for blood glucose level monitoring and to inject drugs into biological tissues.

[0117] Specifically, the piezoelectric sensing module uses a graphene-based piezoelectric sensor as the sensing unit. Glucose oxidase is immobilized on the surface of the graphene layer of the piezoelectric sensor. After the interstitial fluid sample is guided to the piezoelectric sensing module, it flows through a microfluidic channel to the piezoelectric sensor and binds to the glucose oxidase. A certain bias voltage (e.g., 0.1~0.5V) is applied to the sensor to detect the electrical signal. Glucose oxidase catalyzes glucose, converting it into gluconic acid, accompanied by the generation of hydrogen peroxide (H2O2). Each H2O2 molecule injects two electrons into the graphene layer, thereby increasing the Fermi level of the graphene. The increased conductivity of the graphene leads to an increase in the output current. Therefore, the output current of the sensor changes before and after the interstitial fluid sample is added. The byproducts generated by the reaction between the interstitial fluid sample and glucose oxidase are absorbed and processed by a byproduct absorption sponge.

[0118] The specific implementation of the microneedle array is as follows: Figure 6 As shown, it can be punctured through a perforated back cover to collect interstitial fluid or inject insulin. When the watch is worn on the user's wrist, the microneedle array penetrates the skin surface, extracting interstitial fluid into the first fluid chamber. The fluid then flows through the microfluidic channel to the sensor via an acoustic transducer electrode located in the piezoelectric sensing module. The signal processing module processes the electrical signal output by the sensor and calculates the insulin dose accordingly. This drives the insulin from the drug storage module through the drug controlled-release module into the second fluid chamber, thereby guiding it to the microneedle array for injection. Figure 7 As shown, unused interstitial fluid flows back into the user's body through the second fluid chamber. The user can view real-time blood glucose levels, insulin units, battery level, Bluetooth connection status, and other information on the watch's interface.

[0119] Furthermore, the watch strap 505 integrates a force-sensitive resistor to monitor changes in the wearer's physiological stress in real time, particularly detecting physiological parameters such as blood pressure, pulse, and heart rate at the wrist. When the wearer's wrist experiences external pressure, the force-sensitive resistor generates a corresponding resistance signal based on the applied pressure. This signal is processed by the signal processing module and converted into real-time data of physiological parameters such as blood pressure, pulse, or heart rate. The integration of the force-sensitive resistor not only enhances the comfort and convenience of the device but also strengthens the watch's functionality, enabling it to perform multiple health monitoring functions for various physiological indicators. This further supports the precise adjustment of the closed-loop control system in automated drug delivery.

[0120] In terms of compact structural design, for example, microneedle arrays can be achieved by electroplating 316L stainless steel microneedles in a patterned SU-8 mold. For instance, the array size can be designed to be 30*30mm, with microneedle dimensions of 600 µm in length, 250 µm in bottom diameter, and 50 µm in wall thickness. The hydrogel layer on the surface of the microneedle array has a thickness of 200 µm. Another example is the formation of microfluidic channels on the surface of the piezoelectric sensing layer through etching. For example, the channel width can be designed to be 10~100 μm, and the height 50~500 μm. Yet another example is an insulin cartridge with a capacity of 2 ml, encased in a phase change material sheath to stabilize the insulin temperature at 20~25℃.

[0121] All embodiments provided in this invention can be fabricated using standard microelectromechanical systems (MEMS) processes. The selected device structure materials, such as piezoelectric materials (e.g., lithium lithium tantalate, zinc oxide, aluminum nitride, etc.), conductive electrode materials (e.g., gold, platinum, chromium, ITO, etc.), and functional film materials (e.g., graphene oxide, reduced graphene oxide, PDMS, etc.), are all commonly used material systems supported by current MEMS manufacturing platforms, exhibiting good process compatibility and structural repeatability. The structure of each device layer can be achieved through standard micro / nano fabrication processes such as thin film deposition, photolithography, etching, spin coating, surface modification, and bonding encapsulation.

[0122] Therefore, the sensor device described in this invention can be automated and mass-produced using existing MEMS processing platforms, possessing excellent process stability and yield control capabilities. It is easy to integrate into existing health management infrastructures such as medical testing or wearable devices. At the same time, this manufacturing path has good adaptability to the existing industrial chain, which helps to achieve low-cost, large-scale mass production of the device in medical, diagnostic, and biological monitoring scenarios.

[0123] The invention has been described in particular detail above with respect to possible scenarios, and those skilled in the art will recognize that the invention can be practiced through other embodiments. Specific naming of components, capitalization of terms, attributes, data structures, or any other programming or structural aspects are not mandatory or important, and the mechanisms or features of implementing the invention may have different names, forms, or procedures. The system can be implemented through a combination of hardware and software (as described), entirely through hardware elements, or entirely through software elements. The specific division of functions among the various system components described herein is merely exemplary and not mandatory; rather, the functions performed by a single system component can be performed by multiple components, or the functions performed by multiple components can be performed by a single component.

[0124] Those skilled in the art should understand that the various steps of the disclosed methods can be implemented using general-purpose computing devices. They can be centralized on a single computing device or distributed across a network of multiple computing devices. Optionally, they can be implemented using device-executable program code, which can then be stored in a storage device for execution by the computing device. Alternatively, they can be fabricated as separate integrated circuit modules, or multiple modules or steps can be fabricated as a single integrated circuit module. Therefore, the embodiments disclosed in this invention are not limited to any specific hardware and software combination.

[0125] The programs (also referred to as programs, software, software applications, or code) executable by these computing devices include machine instructions of a programmable processor and can be implemented using high-level procedural and / or object-oriented programming languages, and / or assembly / machine languages. As used herein, the terms “machine-readable medium” and “computer-readable medium” refer to any computer program product, device, and / or apparatus (e.g., disk, optical disk, memory, programmable logic device (PLD)) used to provide machine instructions and / or data to a programmable processor, including machine-readable media that receive machine instructions as machine-readable signals. The term “machine-readable signal” refers to any signal used to provide machine instructions and / or data to a programmable processor.

[0126] Those skilled in the art will understand that the structures shown in the figures are merely block diagrams of some structures related to the present application and do not constitute a limitation on the terminal device to which the present application is applied. Specific terminal devices may include more or fewer components than those shown in the figures, or combine certain components, or have different component arrangements.

[0127] In the description of this specification, the use of terms such as "one embodiment," "some embodiments," "example," "specific example," or "possible design," etc., refers to a specific feature, structure, material, or characteristic described in connection with that embodiment or example, which is included in at least one embodiment or example of this application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in a suitable manner in any one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0128] When using expressions such as "at least one of A, B, and C", they should generally be interpreted in accordance with the meaning that is commonly understood by a person skilled in the art (e.g., "a system having at least one of A, B, and C" should include, but is not limited to, a system having A alone, a system having B alone, a system having C alone, a system having A and B, a system having A and C, a system having B and C, and / or a system having A, B, and C, etc.).

[0129] Finally, it should be noted that in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0130] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. An integrated system for monitoring physiological indicators and delivering drugs, characterized in that, It includes a microneedle array, a fluid chamber region, a piezoelectric sensing module, a drug controlled release module, a drug storage module, and a signal processing module; The fluid chamber region includes a first fluid chamber and a second fluid chamber that are isolated from each other by fluid paths. The first fluid chamber is used to receive and unidirectionally guide the body fluid sample obtained by the microneedle array to the piezoelectric sensing module. The second fluid chamber is connected to the drug controlled release module and is used to unidirectionally guide the drug released from the drug storage module to the drug controlled release module to the microneedle array to complete the drug delivery. The piezoelectric sensing module is connected to the first fluid chamber and includes a microfluidic channel and a piezoelectric detection unit. It is used to guide the body fluid sample in the microfluidic channel to the piezoelectric detection unit in the direction of the surface acoustic wave effect, and transmit the output signal to the signal processing module. The signal processing module is communicatively connected to the piezoelectric sensing module and the drug storage module, respectively. It is used to calculate the physiological index monitoring results based on the output signal of the piezoelectric sensing module, calculate the drug delivery dose based on the physiological index monitoring results, and control the drug storage module to release the drug to the drug controlled release module based on the calculated drug delivery dose.

2. The system according to claim 1, characterized in that, The first fluid chamber and the second fluid chamber are disposed on the same chamber layer surface, and an isolation component is provided at the junction of the first fluid chamber and the second fluid chamber for physical isolation of the two fluid chambers.

3. The system according to claim 1, characterized in that, The piezoelectric detection unit includes a sensing layer and a biometric element fixed on the surface of the sensing layer. The biometric element is used to bind with target biomolecules in the body fluid sample to generate reaction products with electron donation and acceptance capabilities. The reaction products undergo charge transfer in the sensing layer, thereby causing a change in the output signal of the piezoelectric detection unit.

4. The system according to claim 1, characterized in that, The piezoelectric detection unit includes a first acoustic transducer layer and a second acoustic transducer layer; Both the first and second acoustic transducer layers utilize surface acoustic waves for fluid control. The first acoustic transducer layer controls the body fluid sample to flow directionally to the piezoelectric detection unit through a microfluidic channel. The second acoustic transducer layer controls the remaining portion of the body fluid sample that is not guided to the piezoelectric detection unit to flow directionally to the second fluid chamber through the microfluidic channel, so that it is unidirectionally guided to the microneedle array through the second fluid chamber.

5. The system according to claim 1, characterized in that, The drug controlled-release module includes an acoustic transducer layer, a measurement area, and a controlled-release area; The acoustic transducer layer uses surface acoustic waves to control the directional flow of the drug to the measurement zone for dosage determination, and controls the directional flow of the drug after dosage determination in the measurement zone to the controlled release zone, so that the drug enters the second fluid chamber through the controlled release zone.

6. The system according to claim 5, characterized in that, The acoustic transducer layer of the drug controlled release module includes a third acoustic transducer layer and a fourth acoustic transducer layer. The third acoustic transducer layer is used to control the directional flow of the drug to the measurement area for dose determination, and the fourth acoustic transducer layer is used to control the directional flow of the drug after dose determination in the measurement area to the controlled release area.

7. The system according to claim 1, characterized in that, The piezoelectric sensing module and the drug controlled release module are disposed on the same piezoelectric layer surface and do not stack on each other on the plane.

8. The system according to claim 1, characterized in that, The microfluidic channels are formed on the surface of the piezoelectric layer by etching.

9. The system according to claim 1, characterized in that, The microfluidic channel of the piezoelectric sensing module is equipped with a first flow direction control unit for directional guidance of body fluid samples.

10. The system according to claim 1, characterized in that, The drug controlled release module is equipped with a second flow control unit for directional guidance of the drug.

11. The system according to claim 1, characterized in that, The microneedles on the microneedle array are provided with side holes.

12. The system according to claim 1 or 11, characterized in that, An isolation layer is provided on the side of the microneedle array that comes into contact with the external biological environment to provide physical isolation between the microneedle array and the external biological environment.

13. The system according to claim 3, characterized in that, The sensing layer of the piezoelectric detection unit includes graphene material or two-dimensional semiconductor material.

14. The system according to claim 1, characterized in that, The drug storage module includes a drug storage unit and a temperature control unit; The drug storage unit is connected to the second fluid chamber and is used to release the drug into the drug controlled release module. The temperature control unit is used to control the drug temperature in the drug storage unit within a preset temperature range.

15. The system according to claim 14, characterized in that, The temperature control unit includes a phase change material or a Peltier element.

16. The system according to claim 1, characterized in that, The system also includes a product absorption element for absorbing byproducts generated when the biorecognition element binds to target biomolecules in a body fluid sample.

17. A wearable application of the integrated physiological indicator monitoring and drug delivery system as described in any one of claims 1 to 17.

18. The wearable application according to claim 17, characterized in that, The wearable application includes a wearable component, on which a flexible pressure sensing module is provided. The flexible pressure sensing module is communicatively connected to the signal processing module in the system and is used to monitor physiological indicators including at least one of blood pressure, pulse, and heart rate.

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