Cognitive state monitoring and intervention device and method

Abstract

The invention discloses a cognitive state monitoring and intervention device and method. The cognitive state monitoring and intervention device comprises a microelectrode drug delivery array module, a wireless transceiving and control circuit module and a power supply module, a microcontroller is embedded in the wireless transceiving and control circuit module; the microelectrode drug delivery array module comprises a hollow drug delivery microneedle, a sensing electrode and a controlled drug delivery electrode; the hollow drug delivery microneedle comprises a hollow microneedle array and a drug storage chamber; the sensing electrode is coupled and fixed on a substrate of the hollow microneedle array, and is attached to the body surface to monitor skin impedance signals when in use, liquid medicine is stored in the medicine storage chamber, and a controlled administration electrode is mounted in the medicine storage chamber; when the wireless transceiving and control circuit module applies current to the controlled dosing electrode, the controlled dosing electrode and the liquid medicine generate electrochemical reaction, and the liquid medicine is pumped into the body surface through the microneedle. According to the invention, the cognitive function state of the body can be continuously monitored, and accurate administration can be automatically realized.

Description

Technical Field

[0001] The present invention relates to the field of biomedical technology, and in particular to a cognitive state monitoring and intervention device and method. Background Art

[0002] When the body is faced with various external or internal stimuli, it will have a systemic nonspecific adaptive response, which is usually called cognitive abnormality. When encountering sudden or urgent dangerous situations, cognitive abnormality is manifested as highly tense and uneasy emotions. For example, excessive external stimulation or pressure may lead to anxiety and negative self-defense mechanisms. These reactions will greatly reduce the individual's cognitive ability, thereby affecting people's ability to make correct behaviors and situation judgments. In severe cases, they may even affect the patient's psychology and mental health, making it impossible for the patient to work and live normally.

[0003] Currently, wearable devices play an important role in monitoring these physiological and biochemical changes, and show great potential in monitoring abnormal cognitive reactions, but these devices still face some challenges in practical applications. First of all, these devices often need to be connected to large peripheral devices for signal reception and processing, which limits their portability and flexibility in extreme environments such as wild forests and plateaus. In addition, the current means of intervention for abnormal cognitive states are relatively limited. It is common practice for doctors to inject relevant recovery factors into patients when they detect abnormal mental cognition in patients. This method of alleviating abnormal cognitive states is no problem for patients who can receive timely treatment, but for patients in extremely harsh environments who cannot seek medical treatment in time and cannot continue to wear relevant devices to detect their status in real time, this treatment method has great limitations. Summary of the invention

[0004] In order to address the above-mentioned deficiencies and defects, the present application provides a cognitive status monitoring and intervention device and method.

[0005] The first aspect of the embodiment of the present invention discloses a cognitive state monitoring and intervention device, comprising: a microelectrode drug delivery array module, a wireless transceiver and control circuit module and a power supply module; the microelectrode drug delivery array module is connected to the wireless transceiver and control circuit module through a wristband to form a wearing space, which is convenient for fixing on the body surface of the detected object. The wireless transceiver and control circuit module is embedded with a microcontroller.

[0006] The microelectrode drug delivery array module includes a hollow drug delivery microneedle, a sensing electrode and a controlled drug delivery electrode; the hollow drug delivery microneedle includes a hollow microneedle array and a drug storage chamber; the hollow microneedle array includes N×M hollow microneedles; the value range of N and M is adjusted according to the drug delivery dose and the required application area.

[0007] The hollow microneedle body is hollow inside, and the hollow part of the hollow microneedle is connected to the drug storage chamber; a microhole is provided on the side of the hollow microneedle body near the needle tip; the microhole is connected to the hollow part of the hollow microneedle; the microhole has a conical aperture inside, and the use of a conical aperture can increase the hardness of the hollow microneedle. The drug storage chamber stores liquid medicine, and the controlled drug administration electrode is fixed in the drug storage chamber, and the controlled drug administration electrode is in contact with the liquid medicine stored in the drug storage chamber; the controlled drug administration electrode is electrically connected to the wireless transceiver and control circuit module.

[0008] The sensing electrode is a gold strip electrode, which is coupled and fixed on the substrate of the hollow microneedle array; the sensing electrode is used to monitor the skin impedance signal, which reflects the influence of the changes in the psychological state of the monitored object on the electrophysiological parameters of the body surface; the sensing electrode is electrically connected to the wireless transceiver and control circuit module through a soft flat cable, and the soft flat cable is embedded in the wristband to send the monitored skin impedance signal to the wireless transceiver and control circuit module; the wireless transceiver and control circuit module converts and integrates the skin impedance signal to obtain an impedance value; when the impedance value is greater than a preset impedance threshold, the wireless transceiver and control circuit module sends a constant microcurrent to the controlled drug administration electrode, and the controlled drug administration electrode produces an electrochemical reaction with the drug solution, generating bubbles, causing the pressure of the drug storage chamber to increase, forcing the drug solution to be pumped out through the hollow part of the hollow microneedle and the micropores and released into the skin.

[0009] The wireless transceiver and control circuit module includes a wireless transceiver unit and a microcontroller, wherein the wireless transceiver unit is electrically connected to the microcontroller; the wireless transceiver unit is wirelessly connected to the control end, and sends information such as monitoring results, liquid medicine usage and power supply to the control end, and can receive command information from the control end; the control end represents a control terminal used by the operator; The power supply module is integrated on the wireless transceiver and control circuit module to provide power for the device.

[0010] As an optional implementation, in the first aspect of the embodiment of the present invention, the hollow microneedle array and the drug storage chamber are integrally prepared from a biocompatible resin using 3D printing technology.

[0011] As an optional implementation, in the first aspect of the embodiment of the present invention, the controlled drug delivery electrode is an interdigitated electrode; the width of the interdigitated electrode is 200 to 220 microns, preferably, the width of the interdigitated electrode is 200 microns; the use of interdigitated electrodes in controlled drug delivery electrodes can effectively reduce operating power consumption.

[0012] As an optional embodiment, in the first aspect of the embodiment of the present invention, the microneedle height of the hollow microneedle is 900-1000 microns; the needle width is 500-1000 microns; the microneedle height is set to be no more than 1000 microns, ensuring that the microneedle pierces the stratum corneum under the condition of minimal skin damage and delivers the drug solution into the skin. The microneedle aspect ratio is 2-2.5, so that the microneedle has sufficient mechanical strength to pierce the stratum corneum.

[0013] As an optional implementation, in the first aspect of the embodiment of the present invention, the wireless transceiver unit uses a 433 MHz frequency band and has a power consumption of no more than 12 mW.

[0014] As an optional implementation, in the first aspect of the embodiment of the present invention, the microcontroller uses a low-power control chip with an impedance measurement function to realize the processing of skin impedance signals.

[0015] As an optional implementation, in the first aspect of the embodiment of the present invention, the power module uses a lithium battery with a voltage of 3.3V and a capacity of not less than 150mAh to meet the requirements of long-term use.

[0016] A second aspect of an embodiment of the present invention discloses a cognitive state monitoring and intervention method, using a cognitive state monitoring and intervention device disclosed in the first aspect of an embodiment of the present invention, the method comprising: S11, fixing the cognitive status monitoring and intervention device on the wrist or other flat skin of the subject to be tested, so that the sensing electrode is attached to the skin, and pressing the device to make the microneedle array penetrate the skin; S12, the sensing electrode monitors the skin impedance in real time and sends the impedance signal to the wireless transceiver and control circuit module; S13, the wireless transceiver and control circuit module converts and integrates the received impedance signal to obtain an impedance value; S14, the wireless transceiver and control circuit module compares the impedance value with a preset impedance threshold; When the impedance value is not greater than the preset impedance threshold, the patient is determined to be cognitively normal, and steps S12 to S14 are executed in a loop; When the impedance value is greater than the preset impedance threshold, the patient is determined to have cognitive abnormalities, and the wireless transceiver and control circuit module sends a constant microcurrent to the controlled drug administration electrode. The controlled drug administration electrode produces an electrochemical reaction with the drug solution and generates bubbles. The generated bubbles cause the pressure in the drug storage chamber to increase, forcing the drug solution to be pumped out through the hollow part of the hollow microneedle and the micropores, and the drug solution is pumped out and released into the skin, completing an automated treatment process.

[0017] S15, during the monitoring process, the device uses the wireless transceiver and control circuit module to send the monitoring results, the use of the liquid medicine and the power supply information to the control end, and can receive the command information from the control end.

[0018] Compared with the prior art, the embodiments of the present invention have the following beneficial effects: 1. The technical solution provided by the present invention can continuously monitor the cognitive function status of the tested body, and automatically adjust the release of the drug solution when specific physiological or psychological state changes are detected to achieve precise drug delivery; the operation process is simple and time-saving, which increases the portability of the equipment.

[0019] 2. The present invention utilizes a wireless transceiver and control circuit module to automatically monitor and intervene in the cognitive state, realizes real-time perception of skin impedance, provides an accurate and real-time perception method, and provides a reliable way to obtain the cognitive state of the human body through biochemical information.

[0020] 3. The present invention adopts the method of controlled delivery of intervention factors by hollow microneedles to achieve safe drug administration in a trace and local release manner, avoiding the systemic toxicity caused by intravenous injection and the first-pass effect of the liver caused by oral administration.

[0021] 4. The present invention adopts a wireless transceiver unit to realize the remote wireless receiving function with the control end, which can realize remote monitoring and control of the control end.

[0022] In summary, the present invention realizes continuous monitoring of the cognitive state of living bodies, processes and feeds back the monitoring signals, and automatically controls the microneedle array to intervene and help restore cognitive functions. These functions greatly promote the application of real-time monitoring and intervention integrated technology in special environments and operations and related clinical disease fields. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 A schematic diagram of the structure of a cognitive state monitoring and intervention device disclosed in an embodiment of the present invention; Figure 2 A schematic diagram of a hollow drug delivery microneedle structure disclosed in an embodiment of the present invention; Figure 3 The present invention is a schematic diagram of a controlled drug delivery electrode structure disclosed in an embodiment of the present invention.

[0024] Reference numerals and descriptions: 1-microelectrode drug delivery array module; 2-sensing electrode; 3-controlled drug delivery electrode; 4-wireless transceiver and control circuit module; 5-power module; 6-hollow microneedle array; 7-drug storage chamber. DETAILED DESCRIPTION

[0025] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0026] Embodiment 1 See also Figure 1 . Figure 1 FIG. 1 is a schematic diagram of the structure of a cognitive state monitoring and intervention device disclosed in an embodiment of the present invention. Figure 1 As shown, the device includes: a microelectrode drug delivery array module 1, a wireless transceiver and control circuit module 4 and a power supply module 5.

[0027] The microelectrode drug delivery array module 1 is connected to the wireless transceiver and control circuit module 4 via a wristband to form a wearing space, which is convenient for fixing on the body surface of the detected object. The wireless transceiver and control circuit module 4 is embedded with a microcontroller.

[0028] The microelectrode drug delivery array module 1 includes a hollow drug delivery microneedle, a sensing electrode 2 and a controlled drug delivery electrode 3; Figure 2 As shown, the hollow drug-delivery microneedle includes a hollow microneedle array 6 and a drug storage chamber 7, and the hollow microneedle array 6 includes N×M hollow microneedles; the value range of N and M is adjusted according to the drug dosage and the required application area; in this embodiment, the hollow microneedle array 6 includes 9×9 hollow microneedles.

[0029] The hollow microneedle body is hollow inside, and the hollow part of the hollow microneedle is connected to the drug storage chamber 7; a microhole is provided on the side of the hollow microneedle body near the needle tip; the microhole is connected to the hollow part of the hollow microneedle; the inside of the microhole is a conical aperture, and the use of a conical aperture can increase the hardness of the hollow microneedle. In this embodiment, the microhole is provided at a position one-third of the distance near the needle tip.

[0030] The drug storage chamber 7 stores drug solution, and the controlled drug administration electrode 3 is fixed in the drug storage chamber 7, which can be fixed by adhesion; the controlled drug administration electrode 3 is in contact with the drug solution stored in the drug storage chamber 7; the controlled drug administration electrode 3 is electrically connected to the wireless transceiver and control circuit module 4.

[0031] The sensing electrode 2 is a gold strip electrode, and the sensing electrode 2 is coupled and fixed on the substrate of the hollow microneedle array 6; the sensing electrode 2 is used to monitor the skin impedance signal, and the skin impedance signal reflects the influence of the psychological state change of the monitored object on the electrophysiological parameters of the body surface; the sensing electrode 2 is electrically connected to the wireless transceiver and control circuit module 4 through a soft flat cable, and the soft flat cable is embedded in the wristband to send the monitored skin impedance signal to the wireless transceiver and control circuit module 4; the two ends of the soft flat cable are connected by a pluggable interface for easy replacement; the wireless transceiver and control circuit module 4 converts and integrates the skin impedance signal to obtain an impedance value; when the impedance value is greater than a preset impedance threshold, the wireless transceiver and control circuit module 4 sends a constant microcurrent to the controlled drug administration electrode 3, and the controlled drug administration electrode 3 produces an electrochemical reaction with the drug solution, generating bubbles, causing the pressure of the drug storage chamber 7 to increase, forcing the drug solution to be pumped out from the hollow part of the hollow microneedle and the micropores and released into the skin.

[0032] It should be noted that the combined structure of the hollow part of the hollow microneedle, the drug storage chamber 7 and the micropump electrode forms an electrochemical drug delivery micropump, and pumps the drug solution out through the micropores.

[0033] The wireless transceiver and control circuit module 4 includes a wireless transceiver unit, which is electrically connected to the microcontroller; the wireless transceiver unit is wirelessly connected to the control end, and sends information such as monitoring results, drug usage and power supply to the control end, and can receive command information from the control end; the control end represents the control terminal used by the operator, which can be a mobile phone or other smart terminal.

[0034] The power module 5 is integrated on the wireless transceiver and control circuit module 4 to provide power for the device.

[0035] It can be seen that the implementation of the cognitive state monitoring and intervention device described in this embodiment can integrate real-time monitoring and intervention of cognitive state, greatly increasing the efficiency of the method and the portability of the equipment, and can implement and continuously monitor the state of cognitive function, and automatically adjust drug release, so as to achieve safe drug delivery in a trace and local release manner and realize precise drug delivery.

[0036] In another optional embodiment, the hollow microneedle array 6 and the drug storage chamber 7 are integrated by 3D printing technology; optionally, the hollow drug delivery microneedle is prepared using biocompatible resin (BIO) resin and a high-precision 3D printing system with a printing accuracy of 25 microns.

[0037] The tissue fluid extraction detection module made of biocompatible resin has good biocompatibility and corrosion resistance, making the detection results more accurate; it has good compression and bending resistance, and is more suitable for the body of the object being collected. The various parts of the hollow drug delivery microneedle are printed as a whole, without gaps, and will not cause air or liquid leakage, making the operation of the device more accurate and the monitored object feel more comfortable.

[0038] In yet another optional embodiment, Figure 3 As shown, the controlled drug administration electrode 3 is an interdigital electrode; the width of the interdigital electrode is 200 to 220 microns, preferably, in this embodiment, the width of the interdigital electrode is 200 microns; the controlled drug administration electrode 3 uses an interdigital electrode to effectively reduce working power consumption.

[0039] In yet another optional embodiment, the controlled drug administration electrode 3 is prepared by screen printing technology.

[0040] In another optional embodiment, the microneedle height of the hollow microneedle is 900-1000 microns; the needle width is 500-1000 microns. When the needle width is greater than 1000 microns, the needle tip will be too thick to penetrate the skin. Preferably, the microneedle height of the hollow microneedle in this embodiment is 1000 microns, the needle width is 500 microns, and the microneedle height is set to 1000 microns, which ensures that the microneedle pierces the stratum corneum under the condition of minimal skin damage and delivers the drug solution to the skin. The aspect ratio of the microneedle is about 2-2.5 to ensure that the microneedle has sufficient mechanical strength to pierce the stratum corneum. If this value is too small / large, the microneedle acupuncture efficiency is reduced, so the needle width is set to 500 microns.

[0041] In another optional embodiment, the wireless transceiver unit adopts the 433MHz frequency band and has a power consumption of no more than 12mW; the microcontroller is a low-power control chip with an impedance measurement function; optionally, ADUCM355 is selected as the microcontroller in this example, which is an ultra-low-power mixed-signal microcontroller based on the Arm® Cortex™-M3 processor with current, voltage and impedance measurement functions.

[0042] It should be noted that the use of a low-power wireless transceiver unit and a microcontroller is conducive to the miniaturization of the device and prolonging the working time. The present application adopts a wireless transceiver unit to receive, process and output wireless signals, realizes the wireless transceiver function under the 433MHz frequency band, can realize long-distance control, and can realize real-time monitoring and intervention of cognitive status even when not close to the object being detected. The 433MHz frequency band is selected for communication, which has the characteristics of high reliability, high stability, strong anti-interference ability, strong penetration ability, and strong environmental adaptability.

[0043] In another optional embodiment, the power module 5 uses a lithium battery with a voltage of 3.3V and a capacity of not less than 150mAh. The lithium battery used in this embodiment can work continuously for 20 days when tested once every 3 hours in actual tests.

[0044] Embodiment 2: The present embodiment discloses a method for monitoring and intervening in cognitive status, using a device disclosed in the first embodiment. The method includes: S11, fixing the cognitive status monitoring and intervention device on the wrist or other flat skin of the subject to be tested, so that the sensing electrode 2 is attached to the skin, and pressing the device to make the microneedle array penetrate the skin; It should be noted that when the device as a whole does not take the form of a wristwatch, a gel dressing may be used to fix the device to the body surface; S12, the sensing electrode 2 monitors the skin impedance in real time and sends the impedance signal to the wireless transceiver and control circuit module 4; S13, the wireless transceiver and control circuit module 4 converts and integrates the received impedance signal to obtain an impedance value; S14, the wireless transceiver and control circuit module 4 compares the impedance value with a preset impedance threshold; When the impedance value is not greater than the preset impedance threshold, the patient is determined to be cognitively normal, and steps S12 to S14 are executed in a loop; When the impedance value is greater than the preset impedance threshold, the patient is determined to have cognitive abnormality, and the wireless transceiver and control circuit module 4 sends a constant microcurrent to the controlled drug administration electrode 3. The controlled drug administration electrode 3 produces an electrochemical reaction with the drug solution and generates bubbles. The generated bubbles cause the pressure in the drug storage chamber 7 to increase, forcing the drug solution to be pumped out through the hollow part of the hollow microneedle and the micropores, and the drug solution is pumped out and released into the skin; completing an automated treatment process; completing an automated treatment process.

[0045] S15, using the wireless transceiver and control circuit module 4 to send the monitoring results, the use of the liquid medicine and the power supply information to the control end, and can receive the command information from the control end.

[0046] Embodiment 3 This embodiment is used to describe the preparation process of the cognitive status monitoring and intervention device described in Embodiment 1, including: S21, create a hollow drug delivery microneedle model using 3D design software; S22, according to the hollow drug delivery microneedle model, using BIO resin and Mofang nanoArchS140 high-precision 3D printing system, printing with a printing accuracy of 25 microns to prepare a primary hollow drug delivery microneedle; S23, washing the primary hollow drug delivery microneedle in 99.9% pure isopropanol for 5 minutes, and curing it with ultraviolet light of 405 nm wavelength at 50 degrees Celsius for 2 hours to obtain a hollow drug delivery microneedle; S24, installing a pair of strip-shaped gold sheets as sensing electrodes 2 on the substrate of the hollow drug delivery microneedle; S25, printing gold ink onto the pre-prepared controlled drug administration electrode 3 mask on the glass substrate by screen printing, and peeling off the glass substrate after the gold ink is solidified to obtain the controlled drug administration electrode 3; S26, assembling the controlled drug delivery electrode 3 and the pre-prepared drug solution into the hollow drug delivery microneedle to obtain a microelectrode drug delivery array module 1; S27, assembling the pre-prepared battery and the wireless transceiver and control circuit module 4 to the microelectrode drug delivery array module 1, and connecting the wireless transceiver and control circuit module 4 to the controlled drug delivery electrode 3 through a flexible printed circuit cable to obtain a cognitive state monitoring and intervention device; It should be noted that the above process ensures the intelligence and controllability of the microneedle electrode drug delivery array device, so that it can release drug solution as needed.

[0047] As an optional implementation, after the cognitive status monitoring and intervention device is prepared, it also includes the following detection process: Characterization examination: The morphology of each module was characterized and examined using a variety of microscopes (optical microscope, scanning electron microscope).

[0048] Biological effect evaluation: Mice were used as experimental models to simulate severe environmental changes and create an experimental animal model of abnormal cognitive state at the mouse level. The prepared cognitive state monitoring and intervention device was attached to the back of the mouse to monitor the impedance changes of the mouse back skin. Signal detection was performed at a frequency of 20KHz, and each detection lasted for 5 to 10 seconds. The wireless transceiver and control circuit module 4 of the device is responsible for receiving and decoding monitoring signals. When the skin impedance value exceeds the preset threshold, the wireless transceiver and control circuit module 4 triggers a constant current, which acts on the electrochemical micropump drug release electrode, thereby pushing the drug solution in the drug storage chamber to be released through the pinhole of the hollow microneedle. The cognitive state of the mouse was detected by behavioral indicators. In addition, high-performance liquid chromatography (HPLC) technology was used to determine the changes in cortisol content in mice over time to evaluate the effect of cognitive recovery.

[0049] Finally, it should be noted that the cognitive state monitoring and intervention device and method disclosed in the embodiments of the present invention disclose only the preferred embodiments of the present invention, which are only used to illustrate the technical solution of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that the technical solutions described in the aforementioned embodiments can still be modified, or some of the technical features therein can be replaced by equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A cognitive status monitoring and intervention device, characterized in that: include: A microelectrode drug delivery array module, a wireless transceiver and control circuit module and a power supply module; the microelectrode drug delivery array module is connected to the wireless transceiver and control circuit module via a wristband to form a wearing space; the wireless transceiver and control circuit module is embedded with a microcontroller; The microelectrode drug delivery array module includes a hollow drug delivery microneedle, a sensing electrode and a controlled drug delivery electrode; the hollow drug delivery microneedle includes a hollow microneedle array and a drug storage chamber; the hollow microneedle array includes N×M hollow microneedles; the value range of N and M is adjusted according to the drug delivery dose and the required application area; The hollow microneedle body is hollow inside, and the hollow part of the hollow microneedle is connected to the drug storage chamber; a microhole is opened on the side of the hollow microneedle body near the needle tip; the microhole is connected to the hollow part of the hollow microneedle; the microhole has a conical aperture; the drug storage chamber stores liquid medicine, the controlled drug administration electrode is fixed in the drug storage chamber, and the controlled drug administration electrode is in contact with the liquid medicine stored in the drug storage chamber; the controlled drug administration electrode is electrically connected to the wireless transceiver and control circuit module; The sensing electrode is a gold strip electrode, and the sensing electrode is coupled and fixed on the substrate of the hollow microneedle array; the sensing electrode is used to monitor the skin impedance signal; the sensing electrode is electrically connected to the wireless transceiver and control circuit module through a flexible flat cable, and the flexible flat cable is embedded in the wristband to send the monitored skin impedance signal to the wireless transceiver and control circuit module; The wireless transceiver and control circuit module includes a wireless transceiver unit, which is electrically connected to the microcontroller; the wireless transceiver unit is wirelessly connected to the control end, and sends the monitoring results, the use of the liquid medicine and the power supply information to the control end, and can receive command information from the control end; the control end represents the control terminal used by the operator; The power supply module is integrated on the wireless transceiver and control circuit module to provide power for the device.

2. The cognitive status monitoring and intervention device according to claim 1, characterized in that: The hollow microneedle array and the drug storage chamber are integrally prepared from biocompatible resin using 3D printing technology.

3. The cognitive status monitoring and intervention device according to claim 1, characterized in that: The controlled drug administration electrode is an interdigital electrode; the width of the interdigital electrode is 200 to 220 microns.

4. The cognitive status monitoring and intervention device according to claim 1, characterized in that: The microneedle height of the hollow microneedle is 900-1000 microns, the needle width is 500-1000 microns, and the aspect ratio of the microneedle is 2-2.

5.

5. The cognitive status monitoring and intervention device according to claim 1, characterized in that: The wireless transceiver unit uses a 433MHz frequency band and has a power consumption of no more than 12mW.

6. The cognitive status monitoring and intervention device according to claim 1, characterized in that: The microcontroller adopts a low-power control chip with an impedance measurement function, and can realize the processing of skin impedance signals.

7. The cognitive status monitoring and intervention device according to claim 1, characterized in that: The power module uses a lithium battery with a voltage of 3.3V and a capacity of not less than 150mAh.

8. A cognitive status monitoring and intervention method, characterized in that: Using the cognitive status monitoring and intervention device according to any one of claims 1 to 7, the method comprises: S11, fixing the cognitive status monitoring and intervention device on the wrist or other flat skin of the subject to be tested, so that the sensing electrode is attached to the skin, and pressing the device to make the microneedle array penetrate the skin; S12, the sensing electrode monitors the skin impedance in real time and sends the impedance signal to the wireless transceiver and control circuit module; S13, the wireless transceiver and control circuit module converts and integrates the received impedance signal to obtain an impedance value; S14, the wireless transceiver and control circuit module compares the impedance value with a preset impedance threshold; When the impedance value is not greater than the preset impedance threshold, the patient is determined to be cognitively normal, and steps S12 to S14 are executed in a loop; When the impedance value is greater than a preset impedance threshold, the patient is judged to have cognitive abnormality, the wireless transceiver and control circuit module sends a constant microcurrent to the controlled drug delivery electrode, the controlled drug delivery electrode and the drug solution produce an electrochemical reaction and generate bubbles, the generated bubbles cause the pressure of the drug storage chamber to increase, forcing the drug solution to be pumped out through the hollow part of the hollow microneedle and the micropores and released into the skin; S15, during the monitoring process, the device uses the wireless transceiver and control circuit module to send the monitoring results, the use of the liquid medicine and the power supply information to the control end, and can receive command information from the control end.

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