Microneedle real-time imaging and drug delivery system

Abstract

A microneedle real-time imaging and drug delivery system comprises a microneedle array disc module used for releasing drugs into a living body and collecting real-time response electrical signals; an excitation power supply module, a signal processing module and a control module; the excitation power supply module is used for receiving an instruction sent by the control module and providing an excitation electric signal for the microneedle array disc module according to the instruction; the signal processing module is used for preprocessing the real-time response electrical signal; the control module is used for carrying out secondary processing on the preprocessing result; the data transmission module is used for transmitting the secondary processing result output by the control module to the upper computer module; and the upper computer module is used for receiving and deeply processing the secondary processing result. According to the invention, the monitored real-time response electrical signal is processed to generate an image, so that a user can observe related conditions of biological subcutaneous tissues in real time, and a better drug administration effect is achieved.

Description

Technical Field

[0001] The present invention relates to the technical field of subcutaneous drug administration in organisms, and in particular to a microneedle real-time imaging and drug administration system. Background Art

[0002] Microneedles are a new drug delivery technology that has attracted much attention in recent years. It refers to a method of administering drugs on the surface of the skin so that the drugs enter the systemic circulation through the skin to produce systemic or local therapeutic effects. It is used in vaccination, diabetes treatment, hair regeneration, skin cancer treatment, etc. in the clinical trial stage. Existing drug delivery microneedles are mainly divided into solid microneedles, coated microneedles, hollow microneedles, soluble microneedles and hydrogel microneedles according to the drug introduction method. The existing microneedle drug delivery system has the following problems: most microneedles have insufficient drug loading due to their structure and drug delivery method; solid microneedles have high mechanical strength during insertion, and the needle tip is easy to break, resulting in fragments remaining in the human body, causing safety hazards; existing soluble microneedles are mainly made of biodegradable materials, the material hardness is relatively low, and the mechanical strength of the needle tip is poor, which makes it difficult to penetrate the skin; drug delivery microneedles are interconnected with multiple holes, making it difficult to achieve real-time monitoring functions and provide accurate treatment feedback; most drug delivery microneedles are difficult to meet the technical requirements for personalized drug delivery in precision medicine.

[0003] It is not difficult to see that there are still many problems in the existing technology, and it is necessary to improve the existing subcutaneous drug administration technology in organisms to overcome the defects of the existing technology. Summary of the invention

[0004] Therefore, in order to solve the above problems in the prior art, the present invention proposes a microneedle real-time imaging and drug delivery system.

[0005] The present invention solves the above problems by the following technical means:

[0006] A microneedle real-time imaging and drug delivery system, comprising:

[0007] A microneedle array disk module is used to release drugs into a living body and receive an externally applied excitation electrical signal; and collect real-time response electrical signals generated by the impedance of the tissue in the living body due to the excitation of the excitation electrical signal; an excitation power supply module, a signal processing module, and a control module; the excitation power supply module is used to receive and provide the excitation electrical signal to the microneedle array disk module according to the instructions issued by the control module; the signal processing module is used to receive and pre-process the real-time response electrical signal collected by the microneedle array disk module, and output the pre-processing result; the control module is used to control and process the size of the excitation electrical signal provided by the excitation power supply module, and receive the pre-processing result output by the signal processing module, perform secondary processing on it, and output the secondary processing result; a data transmission module is used to transmit the secondary processing result output by the control module to the host computer module; the host computer module is used to receive and display the result transmitted by the data transmission module, and perform deep processing on the received result and output the deep processing result.

[0008] The present invention combines the microneedle array disk module, the excitation power module, the signal processing module, the control module, the data transmission module, the host computer module and the server module to monitor in real time the real-time response electrical signal under the skin of the organism during the microneedle drug delivery process in the organism, thereby processing the monitored real-time response electrical signal to generate an image, allowing the user to observe the relevant conditions of the subcutaneous tissue of the organism in real time to achieve a better drug delivery effect.

[0009] Furthermore, the microneedle array disc module comprises:

[0010] The excitation microneedle unit is used to receive the excitation electrical signal provided by the excitation power module; the collection microneedle unit is used to release the drug into the organism and collect the real-time response electrical signal.

[0011] Furthermore, there are two excitation microneedle units and one or more collection microneedle units; the two excitation microneedle units and the one or more collection microneedle units are staggeredly distributed on the front side of the microneedle array disk module.

[0012] It should be noted that the purpose of the present invention using two excitation microneedle units is to apply an excitation electrical signal (including but not limited to applying voltage or directly inputting current, etc.) to the excitation microneedle unit through the excitation power module. We can regard the two excitation microneedle units as two excitation electrodes. When the excitation electrical signal is injected into the imaging target, the two excitation electrodes are in relative positions. The advantages of using two excitation electrodes to input the excitation electrical signal (preferably using input current) are: ensuring that the current excitation is staggered in the object being measured, and the input current field is symmetrical, which helps to reduce the measurement error; when a single excitation electrode is used, the electrode may undergo a polarization effect, affecting the accuracy of the measurement result. Therefore, the present invention preferably adopts a solution of setting two excitation microneedle units.

[0013] Furthermore, the excitation microneedle unit includes: a first conductive base and a first base, the first conductive base is arranged on the first base; the first conductive base and the first base are formed by integral casting, and the surfaces of the first conductive base and the first base are covered with a metal layer. Further, the collection microneedle unit includes: a second conductive base, a second base, a drug feed hole, a soluble drug-loaded needle tip, and an electrical signal collection component, the second conductive base is arranged on the second base, the drug feed hole is arranged at the bottom of the second conductive base, and the soluble drug-loaded needle tip is arranged inside the second conductive base; the electrical signal collection component is arranged at the bottom of the second base, the second conductive base and the second base are formed by integral casting, and the surfaces of the second conductive base and the second base are covered with a metal layer. To make the explanation more detailed.

[0014] For convenience, in this paragraph, the first conductive base and the second conductive base are collectively referred to as conductive bases, and the first base and the second base are collectively referred to as bases. The preparation methods of the excitation microneedle unit and the collection microneedle unit described in the present invention are both formed into polymer solid microneedles by casting polymer materials, and the conductive base and the base are uniformly coated with a metal layer by dip coating, and the metal layer is preferably an inert metal layer.

[0015] Furthermore, the signal processing module uses an amplifier chip combined with a first-order high / low-pass passive filtering network to pre-process the received real-time response electrical signal, and transmits the pre-processing result to the control module; the signal processing module is one or more, and one signal processing module is connected to one acquisition microneedle unit. The present invention uses an amplifier chip and a first-order high / low-pass passive filtering network to pre-process the response electrical signal. First, the polarization voltage of the electrode is filtered out through a high-pass filtering network to prevent the amplifier from saturating. After chip amplification, it is passed through a low-pass filtering network to remove high-frequency noise and reduce common-mode interference.

[0016] Furthermore, the control module uses a primary subtractor, a post-stage voltage amplifier circuit and an analog-to-digital converter to process the preprocessing result transmitted from the signal processing module through the primary subtractor, the post-stage voltage amplifier circuit and the analog-to-digital converter in sequence, and transmits the secondary processing result to the data transmission module. Through the setting of the control module, the preprocessing result processed by the signal processing module is passed through a primary subtractor and amplified several times, and then enters the post-stage voltage amplifier circuit. The amplified analog signal is converted into a digital signal through the analog-to-digital converter, and finally the digital signal is transmitted to the data transmission module.

[0017] Furthermore, the data transmission module adopts a wireless transmission mode, and is mainly used to transmit data between the control module and the host computer.

[0018] Furthermore, the signal processing module, the excitation power module, the control module and the data transmission module are all integrated on the back side of the microneedle array disk module.

[0019] Furthermore, the microneedle real-time imaging and drug delivery system of the present invention further includes: a server module, which is used to receive and store the depth processing results output by the host computer module and is connected to the data transmission module.

[0020] The present invention adopts the structural arrangement of the first conductive base, the first base, the second conductive base, the second base, the drug feed hole and the soluble drug-loaded needle tip. When exposed to body fluids in a living body, the soluble drug-loaded needle tip dissolves to form charged ions, which move in a directed manner under the action of an external electric field, thereby forming an electric current (i.e., an electric signal). Due to the existence of the structure of the first conductive base, the first base, the second conductive base, the second base, the drug feed hole and the soluble microneedle, the propagation path of the electric signal is shorter, interference and attenuation are reduced, and the measurement accuracy and sensitivity are greatly improved.

[0021] The soluble drug-loaded needle tip cooperates with the second conductive base to prevent the microneedle tip from breaking and remaining in the skin during insertion into the body. At the same time, the second conductive base plays a supporting role, ensuring that the soluble drug-loaded needle tip can successfully complete the insertion action.

[0022] Each collection microneedle unit in the microneedle array disk module is connected to a signal processing module. When the excitation power module excites the excitation microneedle unit, the microneedle array disk module can collect the real-time response electrical signal during the treatment process in real time. After being processed and transmitted by the signal processing module, control module and data transmission module, an electrical signal image is formed in the host computer module to assist doctors in evaluating the treatment effect. The second conductive base of the present invention has a drug inlet hole at the bottom, which can effectively solve the problem of small drug delivery and inability to continuously deliver drugs through existing microneedles. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0024] Figure 1 A structural block diagram of the microneedle real-time imaging and drug delivery system provided by the present invention;

[0025] Figure 2 A schematic diagram of a microneedle array disk module provided in an embodiment of the present invention;

[0026] Figure 3 A schematic diagram of a collection microneedle unit provided in an embodiment of the present invention;

[0027] Description of reference numerals:

[0028] Collecting microneedle unit-11, exciting microneedle unit 12,

[0029] The second conductive base-111, the second base-112,

[0030] Drug inlet hole-113, soluble drug-loaded needle tip-114. DETAILED DESCRIPTION

[0031] In order to make the above-mentioned purposes, features and advantages of the present invention more obvious and easy to understand, the technical solution of the present invention will be described in detail below with reference to the accompanying drawings and specific embodiments. It should be pointed out that the described implementation examples 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.

[0032] Example

[0033] The present invention is described in more detail below:

[0034] like Figure 1 and Figure 2 As shown, a microneedle real-time imaging and drug delivery system comprises:

[0035] The microneedle array disc module is used to release drugs into the body and receive an external excitation electrical signal; and collect real-time response electrical signals generated by the impedance of the tissue in the body due to the excitation of the excitation electrical signal. It should be noted that the shape of the microneedle array disc module includes but is not limited to: rectangular, circular, square, triangular, diamond, elliptical and other planar structures.

[0036] Preferably, the microneedle array disc module comprises:

[0037] The excitation microneedle unit 12 is used to receive the excitation electrical signal provided by the excitation power module. Preferably, the excitation microneedle unit 12 includes: a first conductive base (not shown) and a first base (not shown), wherein the first conductive base is arranged on the first base. Preferably, the first conductive base and the first base are integrally cast, and the surfaces of the first conductive base and the first base are both covered with a metal layer. Preferably, the metal layer is an inert metal layer.

[0038] It should be noted that the role of the excitation microneedle unit 12 in the system described in the present invention is to provide an excitation electrical signal to the subepidermis of the organism, and through pre-set parameters, an external module (i.e., the excitation power supply module described below in this embodiment) applies an excitation electrical signal to the excitation microneedle unit 12 (the excitation electrical signal can be selected according to actual needs, including but not limited to: voltage, current, etc.), thereby stimulating the subepidermal tissue of the organism to generate impedance, and a corresponding real-time response electrical signal can be generated in the subepidermal tissue of the organism.

[0039] like Figure 3 As shown, the collection microneedle unit 11 is used to release drugs into the body and collect the real-time response electrical signal; preferably, the collection microneedle unit 11 includes: a second conductive base 111, a second base 112, a drug feed hole 113, a soluble drug-loaded needle tip 114, and an electrical signal collection component (not shown), the second conductive base 111 is arranged on the second base 112, the drug feed hole 113 is arranged at the bottom of the second conductive base 111, and the soluble drug-loaded needle tip 114 is arranged inside the second conductive base 111. Preferably, the electrical signal collection component is arranged at the bottom of the second base 112. Preferably, the second conductive base 111 and the second base 112 are formed by integral casting, and the surfaces of the second conductive base 111 and the second base 112 are covered with a metal layer. Preferably, the metal layer is an inert metal layer.

[0040] It should be noted that there are many preparation methods of the collection microneedle unit 11 and the excitation microneedle unit 12 of the present invention in the prior art. The special feature of the present invention is that according to the structure of human skin and the material of microneedles, and taking into account factors such as the risk of microneedle breakage, the pain of soluble microneedles piercing the skin, and the efficiency of drugs entering the human body, the present invention makes the following recommendations on the specifications of related components: the length of the collection microneedle unit 11 and the excitation microneedle unit 12 is about 300μm to 1000μm, the diameter of the first conductive base and the second conductive base 111 is about 300μm, the taper of the soluble drug-loaded needle tip 114 is about less than 5°, and the center distance of the needles is about 300μm to 2000μm. The first conductive base and the first base, the second conductive base 111 and the second base 112 can all be made of an integrated biodegradable polymer material, and the polymer material includes but is not limited to: one or more of polylactic acid, poly(L-lactic acid) and poly(glycolic acid); the soluble drug-loaded needle tip 114 includes but is not limited to: one or more materials with drug-loading capacity such as polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP) and hyaluronic acid (HA) (the material dissolves when in contact with the interstitial fluid of the skin, and the loaded drug molecules are locally released, which solves the problem of broken needles remaining in the skin that is difficult to handle).

[0041] In the preparation process of the collection microneedle unit 11 and the excitation microneedle unit 12, the present invention preferably performs electrochemical polymerization on the first conductive base and the first base, the second conductive base 111 and the second base 112, using, but not limited to: poly (3, 4 ethylenedioxythiophene) polystyrene sulfonate, polythiophene, polyaniline, polypyrrole, etc. as ion-electron transducers deposited on the first conductive base and the second conductive base 111, preferably using cyclic voltammetry, constant potential method, constant current method, dynamic potential scanning method or pulse method to perform electrochemical polymerization for 20 to 1000 minutes.

[0042] It should be noted that the function of the collection microneedle unit 11 in the system of the present invention is:

[0043] First, release the drug under the epidermis of the organism, and deliver the drug under the epidermis of the organism through the action of the soluble drug-loaded needle tip 114 in the collection microneedle unit 11. The microneedle array disk module is attached to the body surface of the organism, and the soluble drug-loaded needle tip 114 penetrates the stratum corneum and pierces the epidermis of the skin. The soluble drug-loaded needle tip 114 releases the drug it carries, thereby achieving the purpose of drug delivery. The bottom of the second conductive base 111 in the collection microneedle unit 11 is provided with the drug feed hole 113. The purpose of setting the drug feed hole 113 is to facilitate the addition of the drug dosage at any time according to actual needs, which solves the problem that the microneedles currently on the market cannot continuously deliver drugs for multiple times, so it is conducive to personalized and diversified drug delivery.

[0044] Second, collect the real-time response electrical signal. Due to the interaction between the excitation microneedle unit 12 and the excitation power module, the body is stimulated by the excitation electrical signal, and the tissue in the body generates impedance, thereby generating a real-time response electrical signal, which is collected by the collection microneedle unit 11. There are many methods in the prior art that can realize the collection of real-time response electrical signals of tissues in the body. The electrical signal collection component in this embodiment is preferably a single-chip microcomputer.

[0045] Preferably, there are two excitation microneedle units 12 and one or more collection microneedle units 11.

[0046] The two excitation microneedle units 12 and one or more collection microneedle units 11 are staggeredly distributed on the front side of the microneedle array disk module.

[0047] It should be noted that the purpose of the present invention using two excitation microneedle units 12 is to apply an excitation electrical signal (including but not limited to applying voltage or directly inputting current, etc.) to the excitation microneedle unit 12 through the excitation power module. We can regard the two excitation microneedle units 12 as two excitation electrodes. When the excitation electrical signal is injected into the imaging target, the two excitation electrodes are in relative positions. The advantage of using two excitation electrodes to input the excitation electrical signal (preferably using input current) is that it ensures that the current excitation is staggered in the object being measured, and the input current field is symmetrical, which helps to reduce the measurement error; when a single excitation electrode is used, the electrode may have a polarization effect, affecting the accuracy of the measurement result. Therefore, the present invention preferably adopts a solution of setting two excitation microneedle units 12.

[0048] like Figure 2As shown, the two excitation microneedle units 12 and one or more collection microneedle units 11 are staggeredly distributed on the front of the microneedle array plate. It should be noted that there is no special requirement for the arrangement of the excitation microneedle units 12 and the collection microneedle units 11. In addition, the shapes of the excitation microneedle units 12 and the collection microneedle units 11 are both needle-tip or needle-tip-like structures, which can pierce the epidermis of the organism.

[0049] An excitation power supply module, a signal processing module, and a control module; the excitation power supply module is used to receive and provide an excitation electrical signal to the microneedle array disk module according to the instructions issued by the control module; the signal processing module is used to receive and preprocess the real-time response electrical signal collected by the microneedle array disk module, and output the preprocessing result; the control module is used to control and process the size of the excitation electrical signal provided by the excitation power supply module, and receive the preprocessing result output by the signal processing module, perform secondary processing on it, and output the secondary processing result; and transmit the secondary processing result output by the control module to the host computer module; the host computer module is used to receive and display the result transmitted by the data transmission module, and perform deep processing on the received result and output the deep processing result.

[0050] It should be noted that the components of the excitation power supply module include but are not limited to: a micro battery, a switch, a resistor and a wire, which is connected to the control module and provides power for it, and provides a current or voltage signal to the excitation microneedle unit 12 during the drug administration process. Preferably, in this embodiment: the excitation current range is about 10μA~60μA, and the current frequency is in the low frequency range of 1~10kHz; the battery capacity is 100-2000mAh, the resistance value is 0-10KΩ, the battery diameter is about 4mm to 12mm, and the thickness is about 1mm to 5mm.

[0051] Preferably, the signal processing module uses an amplifier chip combined with a first-order high / low-pass passive filtering network to pre-process the received real-time response electrical signal, and transmits the pre-processing result to the control module. The present invention uses an amplifier chip and a first-order high / low-pass passive filtering network to pre-process the response electrical signal. First, the real-time response electrical signal passes through a high-pass filtering network to filter out the polarization voltage of the electrode to prevent the amplifier from saturating. After chip amplification, it passes through a low-pass filtering network to remove high-frequency noise and reduce common-mode interference. It should be noted that in this embodiment, each of the acquisition microneedle units 11 corresponds to a signal processing module, and all signal processing modules are connected to the control module to transmit the pre-processing results to the control module.

[0052] It should be noted that the control module is used to control and process the size of the excitation electrical signal provided by the excitation power module, and receive the preprocessing result output by the signal processing module, perform secondary processing on it, and output the secondary processing result. The control module is responsible for controlling the parameter adjustment of the excitation power module, and controlling the excitation power module to inject the excitation electrical signal into the excitation microneedle unit 12, etc., and also controls the real-time response electrical signal collected by the collection microneedle unit 11, and measures and processes it, etc., that is, receives the preprocessing result output by the signal processing module, performs secondary processing on it, and outputs the secondary processing result. To ensure the accuracy and stability of the real-time response electrical signal (high precision and fast response to achieve real-time imaging). The specific forms implemented by the control module include but are not limited to: microcontroller, analog circuit, etc.

[0053] In this embodiment, as a preference, the control module uses a primary subtractor, a post-stage voltage amplifier circuit and an analog-to-digital converter, and the pre-processing result transmitted from the signal processing module is processed by the primary subtractor, the post-stage voltage amplifier circuit and the analog-to-digital converter in sequence for secondary processing, and the secondary processing result is transmitted to the data transmission module. Through the setting of the control module, the pre-processing result processed by the signal processing module is amplified by the primary subtractor and enters the post-stage voltage amplifier circuit, and the amplified analog signal is converted into a digital signal by the analog-to-digital converter, and finally the digital signal is transmitted to the data transmission module.

[0054] The data transmission module is used to transmit the secondary processing results output by the control module to the host computer module; it should be noted that the specific forms of the data transmission module include but are not limited to: Bluetooth transmission, WiFi transmission, NFC transmission, etc., and Bluetooth transmission is preferably used in this embodiment.

[0055] The host computer module is used to receive and display the results transmitted by the data transmission module, and perform deep processing on the received results and output the deep processing results. As can be seen from the above, the system provided in this embodiment is continuously performing the "excitation-collection" cycle, so the collection microneedle unit 11 continuously and uninterruptedly collects real-time response electrical signals, and the corresponding host computer module will continue to have images in different states. After collecting a certain number of images, the host computer module will perform deep processing on them. This embodiment preferably uses the D-bar algorithm or the layer peeling method to solve the inverse problem of electrical impedance distribution and reconstruct the image. Finally, the electrical impedance distribution of each point on the fault is reflected in a grayscale image or an RGB color image, and the features of the image are extracted and uploaded to the server, that is, the deep processing results are transmitted to the server.

[0056] The server module is used to receive and store the deep processing results output by the host computer module, and is connected to the data transmission module. The server module is mainly used to receive and store the deep processing results. It should be noted that the server module includes but is not limited to: local servers, virtual servers, big data cloud platforms, etc. The deep processing results output by the host computer can be compared with the relevant result data already in the server module. When a closer situation is found after comparison, the server module will send the closer situation to the control module through the data transmission module. The control module then changes the excitation electrical signal of the excitation power module according to the closer situation output by the server module, and adds drugs as needed through the drug inlet 113, thereby helping people implement more accurate drug delivery and medication plans.

[0057] Preferably, the signal processing module, the excitation power module, the control module and the data transmission module are all integrated on the back side of the microneedle array disk module.

[0058] To make the present invention easier to understand, the working process of the microneedle real-time imaging and drug delivery system of the present invention is briefly described below:

[0059] First, a microneedle array disc module is attached to the body surface, and all the excitation microneedle units 12 and collection microneedle units 11 on the microneedle array disc module penetrate the stratum corneum and the epidermis of the skin, and then the soluble drug-loaded needle tip 114 on the collection microneedle unit 11 releases the internal drug. It should be noted that the drugs carried by the soluble drug-loaded needle tip 114 of the present invention include but are not limited to: anticancer drugs, analgesics, contraceptives, vaccines, proteins, peptides, polysaccharide genes, antibodies, local anesthetics, insulin, and one or more combinations thereof.

[0060] Then excitation and collection are performed. In one excitation-collection cycle, the excitation power supply module applies an excitation electrical signal to the excitation microneedle unit 12; at the same time, the collection microneedle unit 11 collects the real-time response electrical signal. At this time, the real-time response electrical signal is an analog signal, and the analog signal enters the signal processing module.

[0061] The real-time response electrical signal collected by each of the collection microneedle units 11 enters the corresponding signal processing module for preprocessing. The preprocessing process is: first, the polarization voltage of the electrode is filtered out through a high-pass filter network to prevent the amplifier from saturating. After chip amplification, the signal is passed through a low-pass filter network to remove high-frequency noise and reduce common-mode interference. The preferred chip in this embodiment is the AD620 amplifier chip.

[0062] The analog signal formed after pre-treatment, then enters the control module, and the memory secondary treatment is recorded in the control module. The process of secondary treatment is: sequentially passing through a first-level subtractor, a rear-stage voltage amplifier circuit and a high-precision analog-to-digital converter. In the present embodiment, preferably, the analog signal formed after pre-treatment enters the rear-stage voltage amplifier circuit after amplifying about 48 times through a first-level subtractor, and the analog signal after amplifying 10 times is converted into a digital signal through a high-precision analog-to-digital converter, and the digital signal is transmitted to the host computer module by the data transmission module, and a high-resolution relationship image is generated in real time in the host computer module, so as to realize the detection and continuous monitoring of the real-time response electrical number in the drug administration process. Preferably, after repeating 1000 times of excitation-collection cycles, the host computer module solves the inverse problem of electrical impedance distribution with D-bar algorithm or layer peeling method, and reconstructs the image, and finally reflects the electrical impedance distribution of each point on the fault with grayscale or RGB color map, extracts the features of the image and uploads it to the server module.

[0063] The present invention combines the microneedle array disk module, the excitation power module, the signal processing module, the control module, the data transmission module, the host computer module and the server module to monitor in real time the real-time response electrical signal under the skin of the organism during the microneedle drug delivery process in the organism, thereby processing the monitored real-time response electrical signal to generate an image, allowing the user to observe the relevant conditions of the subcutaneous tissue of the organism in real time to achieve a better drug delivery effect.

[0064] In the present invention, the microstructure of the first conductive base, the first base, the second conductive base 111, the second base 112, the drug inlet 113 and the soluble drug-carrying needle tip 114 undergoes electrochemical polymerization with the conductive polymer material. When exposed to the body fluid in the organism, the electrolyte in the body dissolves to form charged ions (as can be seen from the above, the first conductive base, the first base, the second conductive base 111, the second base 112, the drug inlet 113 and the soluble drug-carrying needle tip 114 are all integrally cast from the conductive polymer material, and the first conductive base and the second conductive base 111 are subjected to electrochemical polymerization, so when the first conductive base, the first base, the second conductive base 111, the second base 112, the drug inlet 113 and the soluble drug-carrying needle tip 114 are exposed to the body fluid in the organism, the electrolyte in the body dissolves to form charged ions (as can be seen from the above, the first conductive base, the first base, the second conductive base 111, the second base 112, the drug inlet 113 and the soluble drug-carrying needle tip 114 are integrally cast from the conductive polymer material, and the first conductive base and the second conductive base 111 are subjected to electrochemical polymerization, so when the first conductive base, the first base When the base, the second conductive base 111, the second base 112, the drug inlet 113 and the soluble drug-loaded needle tip 114 are exposed to body fluids, the electrolytes in the body dissolve into charged ions) and move in a directed manner under the action of an external electric field (the external electric field is the excitation electric signal applied to the excitation microneedle unit by the excitation power module), thereby forming an electric current (that is, an electric signal). Due to the presence of the microstructure of the first conductive base, the first base, the second conductive base 111, the second base 112, the drug inlet 113 and the soluble microneedle, the propagation path of the electric signal is shorter, interference and attenuation are reduced, and the measurement accuracy and sensitivity are greatly improved.

[0065] The soluble drug-loaded needle tip 114 cooperates with the second conductive base 111 to prevent the microneedle tip from breaking and remaining in the skin during insertion into the body. At the same time, the second conductive base 111 plays a supporting role, ensuring that the soluble drug-loaded needle tip 114 can successfully complete the insertion action.

[0066] Each collection microneedle unit 11 in the microneedle array disk module is connected to a signal processing module. When the excitation power module excites the excitation microneedle unit 12, the microneedle array disk module can collect electrical signals in real time during the treatment process. After the signal processing and transmission, an electrical signal image is formed in the host computer module to assist doctors in evaluating the treatment effect. In addition, the second conductive base 111 of the present invention has a drug inlet hole 113 at the bottom, which can effectively solve the problem of small microneedle drug delivery and inability to continuously deliver drugs.

[0067] References to "one embodiment", "another embodiment", "embodiment", "preferred embodiment", etc. in this specification refer to specific features, structures or characteristics described in conjunction with the example included in at least one embodiment generally described in this application. The appearance of the same expression in multiple places in the specification does not necessarily refer to the same embodiment. Further, when a specific feature, structure or characteristic is described in conjunction with any embodiment, it is claimed that the realization of such feature, structure or characteristic in conjunction with other embodiments also falls within the present invention. Although the present invention is described herein with reference to a number of illustrative examples of the present invention, it should be understood that those skilled in the art can design many other modifications and implementations that fall within the scope and spirit of the principles disclosed in this application. More specifically, within the scope of the present application disclosure, drawings and claims, in addition to the deformation and improvement that can be made to the components and / or layout of the subject combination layout, other uses will also be obvious to those skilled in the art.

Claims

1. A microneedle real-time imaging and drug delivery system, characterized in that: include: The microneedle array disk module is used to release drugs into the body, receive externally applied excitation electrical signals, and collect real-time response electrical signals generated by the impedance of the tissue in the body due to the excitation of the excitation electrical signals; An excitation power supply module, a signal processing module, and a control module; the excitation power supply module is used to receive and provide an excitation electrical signal to the microneedle array disk module according to the instruction issued by the control module; the signal processing module is used to receive and preprocess the real-time response electrical signal collected by the microneedle array disk module, and output the preprocessing result; the control module is used to control and process the size of the excitation electrical signal provided by the excitation power supply module, and receive and perform secondary processing on the preprocessing result output by the signal processing module, and output the secondary processing result; A data transmission module, used for transmitting the secondary processing result output by the control module to the host computer module; The host computer module is used to receive and display the results transmitted by the data transmission module, perform deep processing on the received results and output the deep processing results.

2. The microneedle real-time imaging and drug delivery system according to claim 1, characterized in that: The microneedle array disc module comprises: An excitation microneedle unit, used to receive an excitation electrical signal provided by the excitation power supply module; The collection microneedle unit is used to release the drug into the organism and collect the real-time response electrical signal.

3. The microneedle real-time imaging and drug delivery system according to claim 2, characterized in that: There are two excitation microneedle units and one or more collection microneedle units; The two excitation microneedle units and one or more collection microneedle units are staggeredly distributed on the front side of the microneedle array disk module.

4. The microneedle real-time imaging and drug delivery system according to claim 2, characterized in that: The excitation microneedle unit comprises: A first conductive base and a first base, wherein the first conductive base is arranged on the first base; the first conductive base and the first base are formed by integral casting, and surfaces of the first conductive base and the first base are both covered with a metal layer.

5. The microneedle real-time imaging and drug delivery system according to claim 2, characterized in that: The collection microneedle unit comprises: A second conductive base, a second base, a drug feed hole, a soluble drug-loaded needle tip, and an electrical signal collection component, wherein the second conductive base is arranged on the second base, the drug feed hole is arranged at the bottom of the second conductive base, and the soluble drug-loaded needle tip is arranged inside the second conductive base; the electrical signal collection component is arranged at the bottom of the second base, the second conductive base and the second base are formed by integral casting, and the surfaces of the second conductive base and the second base are covered with a metal layer.

6. The microneedle real-time imaging and drug delivery system according to claim 3, characterized in that: The signal processing module uses a combined processing of an amplifier chip and a first-order high / low pass passive filter network to pre-process the received real-time response electrical signal, and transmits the pre-processing result to the control module; There are one or more signal processing modules, and one signal processing module is connected to one collection microneedle unit.

7. The microneedle real-time imaging and drug delivery system according to claim 6, characterized in that: The control module adopts the joint processing of a first-stage subtractor, a post-stage voltage amplifier circuit and an analog-to-digital converter, and performs secondary processing on the preprocessing result transmitted from the signal processing module through the first-stage subtractor, the post-stage voltage amplifier circuit and the analog-to-digital converter in sequence, and transmits the secondary processing result to the data transmission module.

8. The microneedle real-time imaging and drug delivery system according to claim 1, characterized in that: The data transmission module adopts a wireless transmission mode.

9. The microneedle real-time imaging and drug delivery system according to claim 1, characterized in that: The signal processing module, the excitation power module, the control module and the data transmission module are all integrated on the back of the microneedle array disk module.

10. The microneedle real-time imaging and drug delivery system according to claim 1, characterized in that: Also includes: The server module is used to receive and store the deep processing results output by the host computer module and is connected to the data transmission module.

Images