An intelligent device integrating physical and chemical multimodal diagnosis and treatment for chronic wounds

Abstract

The present invention discloses an intelligent device for integrated physical and chemical multimodal diagnosis and treatment of chronic wounds, which relates to the technical field of flexible intelligent bandage devices, including an intelligent detection system, a treatment system, a flexible spinning substrate and a flexible circuit board. The intelligent detection system and the treatment system are integrated on the flexible spinning substrate. The present invention takes multiple angles related to chronic wounds, including physical and chemical signals, and integrates impedance sensing, temperature sensing, pH sensing, uric acid sensing, glucose sensing and other detection means to obtain chronic wound healing information, comprehensively judge the inflammation of the wound, and adopt an electrical stimulation treatment method. Extremely low voltage and current can eliminate harm to the human body, and cell proliferation, migration and differentiation can be promoted by regulating the endogenous electric field to achieve rapid healing. This method based on the mechanism of human wound healing avoids drug resistance and other toxicity problems and is relatively safer.

Description

Technical Field

[0001] The present invention relates to the technical field of flexible intelligent bandage devices, and in particular to an intelligent device for physical and chemical multimodal diagnosis and treatment of chronic wounds. Background Art

[0002] Chronic wounds are wounds that have failed to restore their functional integrity through an orderly and timely repair process. They may last from 4 weeks to more than 3 months and may be caused by trauma, diabetes, vascular disease, infection, pressure or radiation. Chronic wounds have a serious impact on the quality of life of patients and bring a heavy economic burden. However, wound healing is an extremely complex process. Generally, acute wound healing includes four stages: hemostasis, inflammation, proliferation and remodeling. Different stages will release a variety of physical and chemical information. Therefore, it is crucial to find real-time and quantitative wound assessment methods; in wound treatment, wound bandages play a particularly important role. With the development of history, wound bandages have gradually developed from primitive simple and crude bandaging to today's integrated diagnosis and treatment, from passive to active treatment. Therefore, how to accurately determine the infection of chronic wounds, what effective treatment methods to take, and how to design an integrated diagnosis and treatment system are the problems we need to solve.

[0003] At present, most of the detection of chronic wounds in research adopts a single detection method, which may not be able to accurately detect the inflammation of chronic wounds, and may easily lead to insufficient treatment or overtreatment in subsequent wound treatment. In addition, among the current treatment methods, traditional mechanical methods can cause physical pain and even secondary infection, and drug treatment will more or less lead to bacterial resistance, which is not conducive to subsequent treatment. The emergence of nano-antibacterial particles has gotten rid of the problem of drug resistance caused by antibiotics and other drug delivery methods. However, this material may have certain toxicity, poor heat resistance, and even heavy metals that are not safe for the human body. Summary of the invention

[0004] The purpose of the present invention is to provide an intelligent device for physical and chemical multimodal diagnosis and treatment of chronic wounds to solve the problems existing in the prior art mentioned in the above background technology.

[0005] To achieve the above object, the present invention provides the following technical solutions:

[0006] A physical and chemical multimodal diagnosis and treatment integrated intelligent device for chronic wounds, comprising an intelligent detection system, a treatment system, a flexible spinning substrate and a flexible circuit board. The intelligent detection system and the treatment system are integrated on the flexible spinning substrate and connected to an MCU main control unit, a communication unit and a button battery on the flexible circuit board. The communication unit is connected to an intelligent device.

[0007] Preferably, the intelligent detection system includes an impedance detection unit, a temperature detection unit and a biosensor module; the impedance detection unit includes an AD5933 impedance detection chip and a gel electrode, the gel electrode is a low-impedance and high-adhesion hydrogel electrode, and the AD5933 impedance detection chip is connected to the MCU main control unit; the temperature detection unit uses metal electrode sensing; the biosensor module includes an enzyme sensor electrode and a small molecule sensor electrode, and both use Ag / AgCl as a reference electrode and a platinum electrode as an auxiliary electrode.

[0008] Preferably, the treatment system includes an electrical stimulation module and a low-impedance electrode; the electrical stimulation module is used for electrical diagnosis and treatment of wounds; the low-impedance electrode uses a flexible low-impedance hydrogel, and the low-impedance hydrogel is prepared by doping with dopamine to enhance the flexibility and adhesion properties of PEDOT:PSS hydrogel.

[0009] Preferably, the communication unit includes an RFID reader and an RFID tag, the RFID tag includes a semi-active tag chip and a tag antenna matching the system, the semi-active tag chip operates in the UHF frequency band, the tag antenna is integrated on a flexible circuit board, the RFID tag is connected to the MCU main control unit, and wireless communication is performed using the RFID reader.

[0010] Preferably, the flexible circuit board is an FPC flexible circuit board, the flexible circuit board is embedded above the flexible spinning substrate, and a UHF absorbing material is attached to the back of the flexible circuit board.

[0011] Preferably, the enzyme sensing electrodes include glucose sensing, uric acid sensing, and lactic acid sensing electrodes, and the enzyme sensing electrodes are embedded with dopamine and dripped onto the surface of a gold electrode; the small molecule sensing electrodes include pH sensing, ammonium ion sensing, sodium ion sensing, potassium ion sensing, and calcium ion sensing electrodes.

[0012] Preferably, the biosensor module and the flexible circuit board are patterned on the flexible spinning substrate by evaporating a gold source.

[0013] A method for preparing a low-impedance hydrogel comprises the following specific steps: weighing 0-0.28g of dopamine, prepolymerizing it in an alkaline aqueous solution for 10-30min, adding 5-20 parts of PEDOT:PSS conductive polymer, and stirring it for 0-15min; then adding 100 parts of acrylamide, 0-5 parts of N,N'-methylenebisacrylamide, 5-25 parts of ammonium persulfate, and 0-5 parts of tetramethylethylenediamine, stirring it in a nitrogen atmosphere ice bath for 5-30min; pouring it into a mold and heating it at 60-100°C for 10-30min to make it gel, so as to prepare the low-impedance hydrogel.

[0014] A method for preparing a biosensor module comprises the following specific steps: weighing 0-8 parts of dopamine, 5-20 parts of PEDOT:PSS conductive polymer, 5-20 parts of chloroplatinic acid, 400-500 parts of PBS aqueous solution, and 1-10 parts of peroxidase, mixing and stirring for 12 hours, and spot drying on an electrode surface to prepare a biosensor module.

[0015] Compared with the prior art, the present invention has the following beneficial effects:

[0016] 1. The present invention works from multiple angles related to chronic wounds, including physical and chemical signals, and integrates multiple detection methods such as impedance sensing, temperature sensing, pH sensing, uric acid sensing, glucose sensing, etc. to obtain chronic wound healing information, comprehensively judge the inflammation of the wound, and adopt electrical stimulation treatment methods. Extremely low voltage and current can eliminate harm to the human body, and by regulating the endogenous electric field, it can promote cell proliferation, migration, and differentiation to achieve rapid healing. This method based on the mechanism of human wound healing avoids drug resistance and other toxicity problems and is relatively safer.

[0017] 2. The present invention adopts a hydrogel strategy to improve material flexibility and compatibility. Different from the high Young's modulus and immune response of traditional electrodes, the electrode material is selected as the intrinsically stretchable ionic and electronic conductive polymer PEDOT:PSS, and a cross-linked polydopamine network is introduced to achieve the flexibility and adhesion of the electrode. It has good biocompatibility, provides a good moist environment for wounds, and promotes wound healing. At the same time, dopamine polymerization can realize enzyme embedding, avoiding the problem of shedding during detection in a moist wound environment.

[0018] 3. The present invention integrates sensor detection, electrical stimulation therapy, wireless transmission, and chip modules to realize an intelligent multi-modal diagnosis and treatment integrated flexible system. By continuously monitoring the impedance, temperature, pH, uric acid, and glucose of dynamic chronic wounds, the chronic wound condition is accurately fed back in real time. Then, through a given program for determining inflammation, the external electric field is autonomously regulated to achieve regulation of the endogenous electric field. The inflammation information can also be transmitted to the smart device terminal through Bluetooth wireless transmission. The external electric field is manually adjusted for electrical stimulation therapy to avoid bacterial aggregation and colonization, while promoting the proliferation, migration, and differentiation of cells at the wound to achieve rapid wound healing and restore skin integrity. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 It is a schematic diagram of the structure of the intelligent device in the present invention.

[0020] Figure 2 This is a stress-strain curve of the low-impedance hydrogel in the present invention.

[0021] Figure 3 Graph showing the adhesion performance of the low impedance electrode of the present invention to various materials.

[0022] Figure 4 This is an electrocardiogram signal detection diagram of the present invention.

[0023] Figure 5-7 This is a graph showing the detection results of glucose and uric acid of the present invention.

[0024] Figure 8 This is a pH value detection diagram of the wound of the present invention. DETAILED DESCRIPTION

[0025] In order to make the technical means, creative features, objectives and effects achieved by the present invention easy to understand, the present invention is further explained below in conjunction with specific implementation methods.

[0026] See also Figure 1-8 , the present invention provides a technical solution:

[0027] A physical and chemical multimodal diagnosis and treatment integrated intelligent device for chronic wounds, comprising an intelligent detection system, a treatment system, a flexible spinning substrate and a flexible circuit board. The intelligent detection system and the treatment system are integrated on the flexible spinning substrate and connected to an MCU main control unit, a communication unit and a button battery on the flexible circuit board. The communication unit is connected to an intelligent device.

[0028] The intelligent detection system includes an impedance detection unit, a temperature detection unit and a biosensor module; the biosensor module and the flexible circuit board are patterned on a flexible spinning substrate by evaporating a gold source; the impedance detection unit includes an AD5933 impedance detection chip and a gel electrode, the gel electrode is a low-impedance and high-adhesion hydrogel electrode, the AD5933 impedance detection chip is connected to the MCU main control unit, the wound impedance is detected through the gel electrode, and the data is transmitted to the MCU main control unit; the temperature detection unit uses metal electrode sensing, such as gold, copper and other metal materials.

[0029] The biosensor module includes enzyme sensing electrodes and small molecule sensing electrodes, and both use Ag / AgCl as reference electrodes and platinum electrodes as auxiliary electrodes; the enzyme sensing electrodes include glucose sensing, uric acid sensing, and lactic acid sensing electrodes, and the enzyme sensing electrodes are embedded with dopamine and dripped onto the surface of the gold electrode; the small molecule sensing electrodes include pH sensing, ammonium ion sensing, sodium ion sensing, potassium ion sensing, and calcium ion sensing electrodes. The biosensor module relies on a flexible spinning substrate to enable the smart device to have good air permeability and flexibility; the biosensor module monitors chronic wounds in real time and transmits data to an MCU main control unit, which controls an impedance detection unit and a temperature detection unit to perform physical signal detection on the wound. The monitoring data is written into an RFID reader / writer by the MCU main control unit and transmitted to the smart device via the RFID reader / writer. After the smart device completes the analysis of the wound data, it can autonomously or manually start an electrical stimulation module to implement electrical diagnosis and treatment.

[0030] The treatment system includes an electrical stimulation module and a low-impedance electrode; the electrical stimulation module is used for electrical diagnosis and treatment of wounds; the low-impedance electrode adopts a flexible low-impedance hydrogel, and the low-impedance hydrogel adopts dopamine doping to improve the flexibility and adhesion properties of PEDOT:PSS hydrogel to prepare a low-impedance adhesion hydrogel. The flexible low-impedance hydrogel has good adhesion properties and good contact with the skin, which is conducive to the electrical stimulation device to regulate the endogenous electric field at the wound; when the continuous detection data of the wound is within the normal range, the treatment system can slowly release a low current to promote wound healing; when the wound monitoring data is abnormal, the treatment system will rate it according to the degree of abnormality of different detection indicators, and adjust the current and power supply time of the electrical stimulation module according to different ratings to inhibit bacterial colonization and accelerate the healing speed of the wound; in addition to autonomously adjusting the electrical stimulation treatment parameters based on the detection rating, the detection data can be synchronized to the smart device, and the doctor can manually intervene in the treatment according to the detection data, adjust the treatment plan to accelerate the healing speed of the wound.

[0031] The communication unit includes an RFID reader and an RFID tag. The RFID tag includes a semi-active tag chip and a tag antenna matched with the system. The semi-active tag chip works in the UHF frequency band. The tag antenna is integrated on a flexible circuit board. The RFID tag is connected to the MCU main control unit, and wireless communication is performed using the RFID reader. The flexible circuit board is an FPC flexible circuit board, which is embedded above the flexible spinning substrate, and a UHF absorbing material is attached to the back of the flexible circuit board. The UHF absorbing material can reduce the interference of the human body to the RFID signal. The RFID reader is fixed indoors, and when the RFID tag enters the effective area, it completes the automatic data exchange with the smart dressing. The RFID reader is connected to the smart device via Bluetooth, WIFI or a serial port. The smart device includes a smart phone, a tablet or a computer, etc. The smart device includes a data visualization function, and the continuously monitored wound parameters are plotted into a curve chart and displayed on the page.

[0032] The present invention also provides a method for preparing a low-impedance hydrogel, which comprises the following specific steps: weighing 0-0.28 g of dopamine, prepolymerizing it in an alkaline aqueous solution for 10-30 minutes, adding 5-20 parts of PEDOT:PSS conductive polymer, and stirring for 0-15 minutes; then adding 100 parts of acrylamide, 0-5 parts of N,N'-methylenebisacrylamide, 5-25 parts of ammonium persulfate, and 0-5 parts of tetramethylethylenediamine, stirring for 5-30 minutes in a nitrogen atmosphere ice bath; pouring the mixture into a mold and heating it at 60-100°C for 10-30 minutes to gel it, thereby obtaining a low-impedance hydrogel.

[0033] With other conditions unchanged, 0 g, 0.12 g, 0.16 g and 0.28 g of dopamine raw material were weighed respectively to prepare low impedance hydrogels, such as Figure 2 As shown, the stress-strain curves indicate that the appropriate addition of dopamine can significantly improve the flexibility of the hydrogel, have a lower Young's modulus, and reduce the mechanical mismatch problem with the skin.

[0034] A method for preparing a biosensor module comprises the following specific steps: weighing 0-8 parts of dopamine, 5-20 parts of PEDOT:PSS conductive polymer, 5-20 parts of chloroplatinic acid, 400-500 parts of PBS aqueous solution, and 1-10 parts of peroxidase, mixing and stirring for 12 hours, and spot drying on an electrode surface to prepare a biosensor module.

[0035] Through the preparation of biosensor modules and electrochemical experiments, the intelligent device can detect the patient's electrocardiogram signals, glucose and uric acid, and pH value of the wound, realizing multiple detection functions and providing a basis for the operation of the treatment system.

[0036] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. An intelligent device for physical and chemical multimodal diagnosis and treatment of chronic wounds, characterized in that: It includes an intelligent detection system, a treatment system, a flexible spinning substrate and a flexible circuit board. The intelligent detection system and the treatment system are integrated on the flexible spinning substrate and connected to the MCU main control unit, the communication unit and the button battery on the flexible circuit board. The communication unit is connected to the intelligent device. The intelligent detection system includes an impedance detection unit, a temperature detection unit and a biosensor module; The impedance detection unit includes an AD5933 impedance detection chip and a gel electrode, wherein the gel electrode is a low-impedance and high-adhesion hydrogel electrode, and the AD5933 impedance detection chip is connected to the MCU main control unit; The temperature detection unit adopts metal electrode sensing; The biosensor module includes an enzyme sensing electrode and a small molecule sensing electrode, and both use Ag / AgCl as a reference electrode and a platinum electrode as an auxiliary electrode; The enzyme sensing electrodes include glucose sensing, uric acid sensing, and lactic acid sensing electrodes, and the enzyme sensing electrodes are embedded with dopamine and dripped onto the surface of a gold electrode; The small molecule sensing electrodes include pH sensing, ammonium ion sensing, sodium ion sensing, potassium ion sensing, and calcium ion sensing electrodes; The treatment system includes an electrical stimulation module and a low impedance electrode; The electrical stimulation module is used to perform electrical diagnosis and treatment on the wound; The low-impedance electrode adopts a flexible low-impedance hydrogel, and the low-impedance hydrogel is doped with dopamine to improve the flexibility and adhesion properties of PEDOT:PSS hydrogel to prepare a low-impedance adhesion hydrogel; The flexible circuit board is an FPC flexible circuit board, which is embedded above the flexible spinning substrate, and a UHF absorbing material is attached to the back of the flexible circuit board; The specific steps of preparing the biosensor module are as follows: Weigh 0-8 parts of dopamine, 5-20 parts of PEDOT:PSS conductive polymer, 5-20 parts of chloroplatinic acid, 400-500 parts of PBS aqueous solution, and 1-10 parts of peroxidase, mix and stir for 12 hours, and spot dry on the electrode surface to prepare a biosensor module.

2. According to claim 1, a physical and chemical multimodal diagnosis and treatment integrated intelligent device for chronic wounds is characterized in that: The communication unit includes an RFID reader and an RFID tag. The RFID tag includes a semi-active tag chip and a tag antenna matching the system. The semi-active tag chip operates in the UHF frequency band. The tag antenna is integrated on a flexible circuit board. The RFID tag is connected to the MCU main control unit and uses the RFID reader for wireless communication.

3. The physical and chemical multimodal diagnosis and treatment integrated intelligent device for chronic wounds according to claim 1, characterized in that: The biosensor module and the flexible circuit board are patterned on a flexible spinning substrate by evaporating a gold source.

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