Wearable medical oncology drug detection system based on microneedle array

Abstract

The invention relates to the technical field of tumor drug monitoring, in particular to a wearable medical oncology drug detection system based on a microneedle array. The micro-needle array sampling module is used for minimally invasive extraction of tumor drug molecules in skin interstitial fluid, a micro-needle array is made of polylactic acid-glycolic acid copolymer (PLGA) and graphene composite nanomaterials, the tip of a micro-needle is of a porous structure, the aperture is 50-200 nm, and the length of the micro-needle is 300-800 [mu] m. The micro-needle array only penetrates through the skin cuticle, capillary injury is avoided, pain and infection risks caused by invasive blood sampling are avoided, the wearing comfort of a patient is improved through the wearable design, the micro-needle array is suitable for long-term repeated monitoring, and the compliance of the patient is remarkably improved; real-time and accurate detection: integration of sampling, detection, data transmission and analysis is realized, time consumed from sampling to data feedback is less than or equal to 5 min, and a drug concentration change curve can be captured in real time; and the specific recognition element is combined with a high-sensitivity electrochemical detection technology.

Description

Technical Field

[0001] This invention relates to the field of tumor drug monitoring technology, specifically to a wearable oncology drug detection system based on a microneedle array. Background Technology

[0002] In medical oncology, precise administration of chemotherapy drugs and targeted therapies relies on real-time blood drug concentration monitoring. Its core value lies in avoiding serious adverse reactions such as bone marrow suppression and liver and kidney damage caused by drug accumulation, while also preventing inadequate treatment outcomes due to insufficient dosage. Currently, the mainstream clinical detection methods are high-performance liquid chromatography (HPLC) and mass spectrometry (LC-MS / MS), which, while offering high detection accuracy, have significant limitations:

[0003] The testing process requires professional medical staff to collect venous blood samples, which then undergo multiple steps such as laboratory centrifugation, pretreatment, and instrument analysis. From sample collection to obtaining results, the process usually takes several hours to several days, making it impossible to achieve real-time dynamic monitoring of blood drug concentration and difficult to meet the need for immediate adjustment of individualized dosing regimens.

[0004] Invasive blood collection can easily cause pain and infection risks for patients, especially cancer patients who require long-term and repeated monitoring, resulting in generally low compliance.

[0005] Against the backdrop of iterative upgrades in medical technology, non-invasive or minimally invasive detection technologies are constantly emerging. However, in the field of oncology drug monitoring, there are still technical bottlenecks such as the difficulty in balancing detection sensitivity and specificity, insufficient real-time dynamic monitoring capabilities, and poor long-term stability of wearable devices. An integrated solution that meets the needs of precise clinical drug administration has not yet been formed. Specifically, most existing minimally invasive detection technologies, such as microneedle detection systems, are single-use and lack wearable continuous monitoring capabilities. They have limited extraction efficiency for tumor drugs and lack specific recognition mechanisms, making them susceptible to interference from impurities such as skin metabolites and body fluid proteins, resulting in large errors in the detection of low-concentration drugs. Most systems have not achieved seamless integration of sampling, detection, and data transmission, and the detection results lag behind changes in drug metabolism in the patient's body. The insufficient biocompatibility of microneedle materials can easily cause skin irritation, and the detection module is susceptible to performance degradation due to temperature and humidity during continuous wear, making it difficult to meet the clinical needs of long-term and repeated monitoring for cancer patients.

[0006] With the government's support for precision medicine technology policies, clinical practice has put forward the core requirements of "minimally invasive, real-time, intelligent, and personalized" tumor drug testing. Developing wearable testing systems with high sensitivity and high specificity has become a key direction for breaking through existing technological bottlenecks and improving the safety and effectiveness of medical oncology treatment.

[0007] Therefore, there is a need for a wearable oncology drug detection system based on microneedle arrays to solve the above-mentioned technical problems. Summary of the Invention

[0008] The technical problem solved by this invention:

[0009] Existing detection technologies lack real-time capability: Laboratory detection methods have long time lags and cannot capture the in vivo concentration change curve of tumor drugs in real time, resulting in delayed dosing adjustments, increasing the risk of adverse reactions or the probability of poor treatment effects;

[0010] The contradiction between poor compliance with invasive sampling and low efficiency of minimally invasive techniques: The invasiveness of venous blood collection reduces patient compliance, while traditional minimally invasive sampling techniques are limited by the skin barrier, resulting in low efficiency of drug molecule extraction and difficulty in meeting the needs of accurate detection of low-concentration tumor drugs;

[0011] The detection system has weak specificity and anti-interference ability: the existing microneedle detection system has not been optimized to identify targets based on the molecular structure of tumor drugs, and is easily interfered with by impurities such as skin stratum corneum metabolites and proteins in body fluids, resulting in large deviations in the detection results;

[0012] Lack of integrated wearable monitoring solutions: The integration of "sampling-detection-data transmission-analysis" has not been achieved. Detection data requires manual follow-up processing and cannot be fed back to medical terminals in a timely manner, making it difficult to support rapid decision-making for individualized clinical dosing.

[0013] To address the aforementioned technical problems, this invention provides a wearable oncology drug detection system based on a microneedle array, characterized in that it comprises:

[0014] A microneedle array sampling module is used for minimally invasive extraction of tumor drug molecules from interstitial fluid of the skin. The microneedle array is made of polylactic acid-glycolic acid copolymer (PLGA) and graphene composite nanomaterial. The microneedle tip is provided with a porous structure with a pore size of 50-200 nm and a microneedle length of 300-800 μm.

[0015] A specific biosensor detection module, connected to the microneedle array sampling module, is used to identify and detect tumor drug molecules in interstitial fluid. The module includes an aptamer or monoclonal antibody recognition element for specific tumor drugs, as well as an electrochemical signal conversion unit, with a detection limit of up to 0.1 ng / mL.

[0016] The intelligent data processing and transmission module, electrically connected to the specific biosensor detection module, includes a signal amplification circuit, a data acquisition unit, a Bluetooth / Wi-Fi communication unit, and an edge computing chip, used to convert the detected electrochemical signal into drug concentration data and transmit it to the medical terminal or patient mobile terminal in real time.

[0017] The wearable carrier, made of medical-grade silicone, conforms to the skin surface and is used to fix the microneedle array sampling module, the specific biosensor detection module, and the intelligent data processing and transmission module. The carrier surface is provided with breathable pores, with a breathability rate of ≥30%.

[0018] The power supply module supplies power to the entire system. It uses a flexible thin-film lithium battery with a capacity of 50-200mAh and supports wireless charging.

[0019] As a further aspect of the present invention, the porous structure of the microneedle array sampling module is prepared by a template method, and the mass ratio of graphene in the composite nanomaterial is 5-15% to improve the conductivity and drug molecule adsorption capacity of the material.

[0020] As a further aspect of the present invention, the identification element of the specific biosensing detection module is covalently modified on the electrode surface, and the electrode is a flexible carbon electrode modified with gold nanoparticles, which effectively improves the fixation amount of the identification element and the signal response speed.

[0021] As a further aspect of the present invention, the edge computing chip of the intelligent data processing and transmission module has a built-in drug concentration-time curve fitting algorithm, which can calculate key pharmacokinetic parameters such as drug half-life and peak concentration in real time, and trigger an alert when the drug concentration exceeds the safe range through an early warning algorithm.

[0022] As a further aspect of the present invention, the wearable carrier adopts an ergonomic design to fit the upper arm, abdomen and other parts of the human body. The surface of the carrier in contact with the skin is coated with medical-grade hydrogel to reduce skin irritation and improve wearing comfort.

[0023] As a further aspect of the present invention, the power supply module also includes a low-power management unit, which automatically reduces power consumption to ≤5μW when the system is in standby mode, thereby extending battery life.

[0024] The method for detecting oncology drugs in the system is characterized by comprising the following steps:

[0025] S1: The wearable carrier is attached to the designated site of the patient, and the microneedles of the microneedle array sampling module are inserted into the epidermal layer of the skin to extract interstitial fluid.

[0026] S2: Tumor drug molecules in the interstitial fluid bind to the recognition element of the specific biosensor detection module, generating an electrochemical signal. The signal is amplified by the amplification circuit and then transmitted to the data acquisition unit.

[0027] S3: The intelligent data processing and transmission module converts electrochemical signals into drug concentration data, calculates pharmacokinetic parameters through algorithms, and transmits the data to the medical terminal in real time.

[0028] S4: After receiving the data, the medical terminal adjusts the dosing regimen according to the changes in drug concentration. If the drug concentration exceeds the safe range, the system triggers an early warning.

[0029] The beneficial effects of this invention are:

[0030] Minimally invasive and highly compliant: The microneedle array penetrates only the stratum corneum of the skin, without damaging capillaries, avoiding the pain and infection risks of invasive blood collection. The wearable design improves patient comfort and is suitable for long-term repeated monitoring, significantly improving patient compliance.

[0031] Real-time and accurate detection: It achieves integrated "sampling-detection-data transmission-analysis", with a time of ≤5min from sampling to data feedback, and can capture drug concentration change curves in real time; the combination of specific recognition elements and high-sensitivity electrochemical detection technology has a detection limit as low as 0.1ng / mL, strong anti-interference ability, and ensures accurate and reliable detection results;

[0032] Intelligence and convenience: The edge computing chip processes data and calculates pharmacokinetic parameters in real time, automatically warns of abnormal concentrations, and transmits data to medical terminals and patient mobile devices in real time without the need for manual follow-up processing. This supports doctors in quickly adjusting dosing regimens and improves the efficiency of individualized clinical treatment.

[0033] Excellent stability and compatibility: The microneedle material has excellent biocompatibility, the wearable carrier is breathable and comfortable, and the power supply module has strong battery life to meet the needs of long-term use; the specific recognition element can be replaced according to different tumor drugs, and it is compatible with the detection of a variety of chemotherapy drugs and targeted drugs, with high compatibility.

[0034] Obviously, based on the above description of the present invention, and according to common technical knowledge and conventional methods in the field, various other modifications, substitutions or alterations can be made without departing from the basic technical concept of the present invention.

[0035] The following detailed embodiments further illustrate the above-described content of the present invention. However, this should not be construed as limiting the scope of the present invention to the following examples. All technologies implemented based on the above-described content of the present invention fall within the scope of the present invention. Detailed Implementation

[0036] The present invention is illustrated below with specific embodiments, which are not intended to limit the scope of the invention.

[0037] A wearable oncology drug detection system based on microneedle array includes a microneedle array sampling module, a specific biosensor detection module, an intelligent data processing and transmission module, a wearable carrier and a power supply module. The modules work together to achieve minimally invasive, real-time, and accurate detection and data feedback of oncology drugs.

[0038] Microneedle array sampling module: Made of polylactic acid-glycolic acid copolymer (PLGA) and graphene composite nanomaterials. PLGA has good biocompatibility and biodegradability, while graphene can improve the material's conductivity and drug molecule adsorption capacity. The graphene content in the composite nanomaterial is 5-15% by mass. The microneedles are designed with a length of 300-800μm, which can penetrate the stratum corneum of the skin but do not reach the capillaries of the dermis, realizing minimally invasive sampling. The microneedle tips are prepared with a porous structure of 50-200nm using a template method to increase the contact area with interstitial fluid and improve the drug molecule extraction efficiency, which is especially suitable for the collection of low-concentration macromolecular targeted drugs and hydrophobic chemotherapy drugs.

[0039] Specific biosensor detection module: Directly connected to the microneedle array sampling module, it receives collected interstitial fluid samples. The core of the module includes a recognition element and an electrochemical signal conversion unit. The recognition element selects the corresponding aptamer or monoclonal antibody based on the molecular structure of the target tumor drug, such as paclitaxel or trastuzumab, and covalently modifies the electrode surface to ensure recognition specificity. The electrode is a flexible carbon electrode modified with gold nanoparticles. The gold nanoparticles increase the immobilization of the recognition element, and the flexible carbon electrode adapts to the bending characteristics of wearable carriers while enhancing signal response speed. When drug molecules bind to the recognition element, they cause changes in the electrochemical properties of the electrode surface, generating corresponding current or voltage signals. The detection limit can reach 0.1 ng / mL, meeting the clinical needs for low-concentration drug detection and effectively resisting interference from impurities such as skin metabolites and body fluid proteins.

[0040] Intelligent data processing and transmission module: Electrically connected to the specific biosensor detection module, it includes a signal amplification circuit, a data acquisition unit, a Bluetooth / Wi-Fi communication unit, and an edge computing chip. The signal amplification circuit amplifies the weak electrochemical signal output from the biosensor module by 1000-10000 times, ensuring data acquisition accuracy. The data acquisition unit acquires the amplified signal at a frequency of 1-5Hz and converts it into a digital signal. The edge computing chip has a built-in drug concentration-time curve fitting algorithm, which can convert the digital signal into drug concentration data in real time and calculate key pharmacokinetic parameters such as drug half-life, peak concentration, and trough concentration. Simultaneously, the chip has a built-in early warning algorithm that automatically triggers an alert function when the drug concentration exceeds a preset safety range. The Bluetooth / Wi-Fi communication unit can transmit drug concentration data, pharmacokinetic parameters, and early warning information to the patient's mobile device and medical terminal in real time, enabling instant data sharing.

[0041] Wearable Carrier: Made of medical-grade silicone, offering excellent flexibility and biocompatibility. The carrier surface features breathable pores with a breathability rate of ≥30%, preventing skin stuffiness from prolonged wear. Ergonomically designed, the carrier's shape and size can be adjusted to fit the skin. The skin-contact surface is coated with medical-grade hydrogel to further reduce microneedle irritation, enhance wearing comfort, and meet the needs of patients for long-term, repeated monitoring. Internal grooves and fixing structures stabilize the microneedle array sampling module, specific biosensor detection module, and intelligent data processing and transmission module, preventing module displacement that could affect detection accuracy.

[0042] Power supply module: Employs a flexible thin-film lithium battery with a capacity of 50-200mAh and a thickness of ≤1mm, adaptable to the slim design of wearable devices; supports wireless charging with a charging efficiency of ≥80%, and can meet the system's continuous operation for 24-72 hours on a full charge. The module also integrates a low-power management unit, which automatically reduces power consumption to ≤5μW when the system detects no change in drug concentration or is in standby mode, extending battery life and reducing the frequency of charging for patients.

[0043] Furthermore, the present invention also provides a method for detecting oncology drugs based on the above system, comprising the following steps:

[0044] System wearing and sampling start-up: Medical staff select the upper arm or abdomen as the sampling site according to the patient's condition. After cleaning the skin, the wearable carrier is attached and fixed. The microneedles of the microneedle array sampling module are inserted into the epidermal layer of the skin. The system is started and the porous structure of the microneedle tip begins to absorb the interstitial fluid of the skin.

[0045] Drug detection and signal conversion: Tumor drug molecules in the interstitial fluid enter the specific biosensor detection module through adsorption, bind to the recognition element, and cause changes in the electrochemical signal on the electrode surface. The signal is amplified by the signal amplification circuit and then collected and converted into a digital signal by the data acquisition unit.

[0046] Data processing and transmission: The edge computing chip receives digital signals, converts them into drug concentration data through built-in algorithms, calculates pharmacokinetic parameters, and determines whether the drug concentration is within a safe range. If the concentration is abnormal, an early warning is triggered, and the Bluetooth / Wi-Fi communication unit transmits the drug concentration data, parameters, and warning information to the patient's mobile device and medical terminal in real time.

[0047] Dosing regimen adjustment: After receiving data, the medical terminal allows doctors to adjust the dosage or dosing interval in a timely manner based on the drug concentration trend and pharmacokinetic parameters; patients can view their own drug concentration and receive early warning reminders through mobile devices, thus improving treatment adherence.

[0048] Example 1: A detection system for paclitaxel chemotherapy drugs.

[0049] In this embodiment, the target drug is paclitaxel, and the modules of the system based on this invention are designed as follows:

[0050] Microneedle array sampling module: It adopts PLGA and graphene composite nanomaterials, with graphene accounting for 10% by mass; the microneedles are 500μm in length and have a porous structure with a pore size of 100nm at the tip. It is prepared by template method. The porous structure can effectively adsorb paclitaxel molecules in interstitial fluid, solving the extraction problem caused by its hydrophobicity.

[0051] Specific biosensor detection module: The recognition element is selected as the paclitaxel aptamer, which is covalently modified on the surface of a flexible carbon electrode modified with gold nanoparticles via thiol-gold bonds; the electrochemical signal conversion unit uses differential pulse voltammetry for detection. When paclitaxel binds to the aptamer, the electron transfer resistance on the electrode surface increases, and the current signal decreases. The paclitaxel concentration is calculated based on the change in current. The detection limit is 0.08 ng / mL, which can resist interference from skin stratum corneum metabolites such as cholesterol, ceramides and albumin in body fluids.

[0052] Intelligent data processing and transmission module: The signal amplification circuit amplifies the volt-ampere signal by 5000 times, and the data acquisition unit acquires the signal at a frequency of 3Hz; the edge computing chip has a built-in paclitaxel concentration-time curve fitting algorithm to calculate the paclitaxel half-life and peak concentration in real time; the Bluetooth communication unit adopts the Bluetooth 5.0 protocol to transmit data to the patient's mobile APP and the hospital's oncology department medical terminal. When the concentration is >20μg / mL or <10μg / mL, the APP and the medical terminal simultaneously trigger an audible and visual warning.

[0053] Wearable carrier: Designed as an upper arm ring-shaped silicone carrier with an inner diameter of 15-20cm, a thickness of 2mm, a surface vent diameter of 0.5mm, a vent spacing of 2mm, and a breathability of 40%; the surface in contact with the skin is coated with medical-grade hyaluronic acid hydrogel to reduce discomfort during microneedle insertion.

[0054] Power supply module: It adopts a 100mAh flexible thin-film lithium battery with a thickness of 0.8mm, supports Qi wireless charging protocol, has a charging efficiency of 85%, can work continuously for 48 hours when fully charged, and has a standby power consumption of 3μW.

[0055] Detection method steps:

[0056] After the patient received chemotherapy, the medical staff cleaned the patient's upper arm skin, fixed the ring-shaped wearable carrier to the outside of the upper arm, inserted microneedles into the epidermal layer of the skin, and activated the system.

[0057] The porous structure at the tip of the microneedle adsorbs interstitial fluid, and paclitaxel molecules enter the biosensing module, bind to the aptamer, and generate an electric current signal. The signal is amplified and captured by the data acquisition unit.

[0058] The edge computing chip converts the current signal into paclitaxel concentration data, calculates the half-life and peak concentration, and immediately triggers an alarm if the concentration is 22 μg / mL.

[0059] The medical terminal receives early warning information and concentration curves. If the doctor determines that there is a risk of drug accumulation, the dosage of paclitaxel in the next cycle will be adjusted from 175 mg / m² to 150 mg / m², and the patient will be notified via the APP. The patient can check the concentration changes in real time through the APP and confirm the dosage adjustment information.

[0060] Example 2 is a detection system for trastuzumab targeted drug.

[0061] In this embodiment, the target drug is trastuzumab, and the system module design is as follows:

[0062] Microneedle array sampling module: The graphene content in the PLGA and graphene composite nanomaterial is 15%, which enhances the adsorption capacity of macromolecular drugs; the microneedles are 600μm long and have a porous structure at the tip with a pore size of 150nm, which increases the entry channel of trastuzumab molecules.

[0063] Specific biosensor detection module: The recognition element is an anti-trastuzumab monoclonal antibody, which is modified onto the surface of a flexible carbon electrode made of gold nanoparticles by glutaraldehyde cross-linking. Detection is performed using chronoamperometry. After trastuzumab binds to the antibody, an immune reaction occurs on the electrode surface, generating a continuous current signal. The current intensity is linearly related to the drug concentration, with a detection limit of 0.05 ng / mL, which can effectively exclude interference from other immunoglobulins in body fluids.

[0064] Intelligent data processing and transmission module: The signal amplification circuit has a magnification factor of 10,000 and a data acquisition frequency of 5Hz; the edge computing chip has a built-in trastuzumab pharmacokinetic algorithm to calculate the steady-state trough concentration in real time; the Wi-Fi communication unit transmits data to the medical terminal and also supports connection with the patient's family's mobile terminal for convenient family members to assist in monitoring; when the concentration is <10μg / mL, the system judges it as a risk of insufficient treatment and triggers an early warning.

[0065] Wearable carrier: Designed as an abdominal patch carrier, measuring 5cm×8cm, with a thickness of 1.5mm and a breathability of 35%; medical pressure-sensitive adhesive is applied to the edges of the carrier to enhance fit and prevent displacement during activity.

[0066] Power supply module: It adopts a 150mAh flexible thin-film lithium battery, supports wireless charging, has a full charge life of 72 hours, and a standby power consumption of 4μW.

[0067] Detection method steps:

[0068] During trastuzumab treatment, breast cancer patients apply an abdominal patch to the skin around the navel every morning, and microneedles are inserted into the epidermis to initiate detection.

[0069] Trastuzumab in the interstitial fluid binds to the monoclonal antibody of the biosensing module, generating an electric current signal. The signal is amplified, acquired, and then transmitted to the edge computing chip.

[0070] The chip calculates that the steady-state trough concentration of trastuzumab is 8 μg / mL, triggering a treatment insufficiency warning. The data is then synchronously transmitted to the medical terminal and the patient's family's mobile device.

[0071] After reviewing the concentration change curve, the doctor determined that the patient's drug clearance rate was too fast and adjusted the dosing interval from once every 3 weeks to once every 2 weeks, while increasing the dose by 50mg. The patient's family received the alert and adjustment plan via mobile device, reminding the patient to have timely follow-up visits.

[0072] Example 3: A detection system for oxaliplatin chemotherapy drugs.

[0073] In this embodiment, the target drug is oxaliplatin, and the system module design is as follows:

[0074] Microneedle array sampling module: The graphene content in the PLGA and graphene composite nanomaterial is 5%, which reduces material costs while ensuring sampling efficiency; the microneedles are 300μm long and have a porous tip with a pore size of 50nm, which is suitable for the rapid adsorption of water-soluble drugs.

[0075] Specific biosensor detection module: The recognition element is an oxaliplatin aptamer, which is modified on the surface of a flexible carbon electrode made of gold nanoparticles through amino-carboxyl covalent bonds; cyclic voltammetry is used for detection. After oxaliplatin binds to the aptamer, the redox peak potential of the electrode shifts. The drug concentration is calculated based on the potential shift. The detection limit is 0.1 ng / mL, which can resist interference from electrolytes such as chloride ions and sodium ions in body fluids.

[0076] Intelligent data processing and transmission module: The signal amplification circuit has a magnification factor of 1000 times and a data acquisition frequency of 1Hz; the edge computing chip has a built-in oxaliplatin concentration warning algorithm, and the safe concentration range is set to 2-8μg / mL; the Bluetooth communication unit transmits data to the patient's mobile APP, which supports linkage with the hospital's chemotherapy department's medical order system to automatically associate with the patient's medication plan; when the concentration is >8μg / mL, a neurotoxicity risk warning is triggered.

[0077] Wearable carrier: Designed as a wristband carrier, with a width of 2cm and a diameter of 5-7cm to fit different wrist sizes; the carrier is made of breathable silicone and fabric composite material to improve breathability and aesthetics.

[0078] Power supply module: It adopts a 50mAh flexible thin-film lithium battery, supports wireless charging, has a full charge life of 24 hours, and a standby power consumption of 5μW, which is suitable for high-frequency monitoring during short chemotherapy cycles.

[0079] Detection method steps:

[0080] On the day a colorectal cancer patient receives oxaliplatin chemotherapy, they wear a wristband-type carrier, and microneedles are inserted into the epidermal layer of the wrist to initiate real-time monitoring.

[0081] After the drug enters the body, oxaliplatin in the interstitial fluid binds to the aptamer of the biosensor module, causing a shift in the redox peak potential of the electrode. The signal is then processed and converted into concentration data.

[0082] When the concentration of oxaliplatin reaches 9 μg / mL, the system triggers a neurotoxicity risk warning, and the APP immediately pushes the warning information to the patient and doctor, while displaying the historical concentration curve.

[0083] Based on the warning information, the doctor decided to suspend the remaining chemotherapy drugs infusion, administer vitamin B12 for neurotrophic therapy, and adjust the oxaliplatin dose for the next cycle from 85mg / m² to 65mg / m². The patient can view the warning reason and treatment plan through the APP and cooperate with the doctor to complete the treatment adjustment.

[0084] 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 process, method, article, or apparatus.

[0085] The above description is merely a preferred embodiment of the present invention and does not limit the patent scope of the present invention. Any equivalent structural transformations made using the contents of the present invention under the inventive concept of the present invention, or direct / indirect applications in other related technical fields, are included within the patent protection scope of the present invention.

[0086] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A wearable oncology drug detection system based on a microneedle array, characterized in that, include: A microneedle array sampling module is used for minimally invasive extraction of tumor drug molecules from interstitial fluid of the skin. The microneedle array is made of polylactic acid-glycolic acid copolymer (PLGA) and graphene composite nanomaterial. The microneedle tip is provided with a porous structure with a pore size of 50-200 nm and a microneedle length of 300-800 μm. A specific biosensor detection module, connected to the microneedle array sampling module, is used to identify and detect tumor drug molecules in interstitial fluid. The module includes an aptamer or monoclonal antibody recognition element for specific tumor drugs, as well as an electrochemical signal conversion unit, with a detection limit of up to 0.1 ng / mL. The intelligent data processing and transmission module, electrically connected to the specific biosensor detection module, includes a signal amplification circuit, a data acquisition unit, a Bluetooth / Wi-Fi communication unit, and an edge computing chip, used to convert the detected electrochemical signal into drug concentration data and transmit it to the medical terminal or patient mobile terminal in real time. The wearable carrier, made of medical-grade silicone, conforms to the skin surface and is used to fix the microneedle array sampling module, the specific biosensor detection module, and the intelligent data processing and transmission module. The carrier surface is provided with breathable pores, with a breathability rate of ≥30%. The power supply module supplies power to the entire system. It uses a flexible thin-film lithium battery with a capacity of 50-200mAh and supports wireless charging.

2. The system according to claim 1, characterized in that, The porous structure of the microneedle array sampling module is prepared by template method. The mass ratio of graphene in the composite nanomaterial is 5-15% to improve the conductivity and drug molecule adsorption capacity of the material.

3. The system according to claim 1, characterized in that, The identification element of the specific biosensing detection module is covalently modified on the electrode surface. The electrode is a flexible carbon electrode modified with gold nanoparticles, which effectively improves the fixation of the identification element and the signal response speed.

4. The system according to claim 1, characterized in that, The edge computing chip of the intelligent data processing and transmission module has a built-in drug concentration-time curve fitting algorithm, which can calculate key pharmacokinetic parameters such as drug half-life and peak concentration in real time, and trigger an alert when the drug concentration exceeds the safe range through an early warning algorithm.

5. The system according to claim 1, characterized in that, The wearable carrier is ergonomically designed to fit the upper arm, abdomen, and other parts of the body. The surface of the carrier that comes into contact with the skin is coated with medical-grade hydrogel to reduce skin irritation and improve wearing comfort.

6. The system according to claim 1, characterized in that, The power supply module also includes a low-power management unit, which automatically reduces power consumption to ≤5μW when the system is in standby mode, thereby extending battery life.

7. A method for detecting oncology drugs based on the system described in any one of claims 1-6, characterized in that, Includes the following steps: S1: The wearable carrier is attached to the designated site of the patient, and the microneedles of the microneedle array sampling module are inserted into the epidermal layer of the skin to extract interstitial fluid. S2: Tumor drug molecules in the interstitial fluid bind to the recognition element of the specific biosensor detection module, generating an electrochemical signal. The signal is amplified by the amplification circuit and then transmitted to the data acquisition unit. S3: The intelligent data processing and transmission module converts electrochemical signals into drug concentration data, calculates pharmacokinetic parameters through algorithms, and transmits the data to the medical terminal in real time. S4: After receiving the data, the medical terminal adjusts the dosing regimen according to the changes in drug concentration. If the drug concentration exceeds the safe range, the system triggers an early warning.