A fully integrated miniature wireless wearable patch system

Abstract

This invention relates to the field of wearable medical device technology, specifically to a fully integrated miniature wireless wearable patch system, comprising a wound detection and treatment circuit, a flexible multi-channel electrode array, and a host computer processing module, including in-situ wound detection and electrostimulation therapy functions. The electrode array includes glucose sensing electrodes, lactic acid sensing electrodes, uric acid sensing electrodes, pH sensing electrodes, temperature sensing electrodes, and electrostimulation electrodes. The wound detection and treatment circuit transmits commands and interacts with data via a Bluetooth module, performing real-time in-situ measurement of wound exudate. After processing the received electrochemical and physical signals and combining them with the current wound state, it obtains a personalized electrostimulation intensity, which is output to the electrostimulation electrodes to promote wound healing. This system provides a remote monitoring platform for wound management, enabling real-time in-situ detection of wound status and timely adjustment of electrostimulation parameters, providing personalized electrostimulation treatment plans.

Description

Technical Field

[0001] This invention relates to the field of wound monitoring and treatment equipment, specifically to a personalized wound electrochemical monitoring and electrical stimulation system. Background Technology

[0002] The wound healing process can be broadly divided into four phases: hemostasis, inflammation, proliferation, and remodeling. Under various conditions, wound healing can slow down or even stall, leading to chronic wounds. Therefore, timely and effective wound management during the healing process is crucial for reducing infection and accelerating healing. At each stage of the healing process, the chemical composition of wound exudate changes significantly, indicating the healing stage and even the presence of infection. For example, elevated temperature is associated with bacterial infection, and temperature changes can provide information on various factors related to wound bed healing, inflammation, and oxygenation; acidity indicates the healing status, protease activity balance, and the degree of extracellular matrix remodeling; furthermore, an elevated pH in the wound environment may be a sign of infection; lactic acid is an important marker for the diagnosis of soft tissue infections and angiogenesis in diabetic foot ulcers; and glucose in wound exudate is strongly correlated with blood glucose and bacterial activity, providing important treatment guidance for diabetic wounds.

[0003] Current wound treatments typically require surgical intervention, and the electrical stimulation devices reported so far often require bulky equipment and wiring. As an alternative treatment, electrical stimulation has been shown to have a significant impact on the wound healing process, including stimulating fibroblast proliferation and differentiation into myofibroblasts and collagen formation, keratinocyte migration, angiogenesis, and macrophage attraction.

[0004] However, most existing smart dressing patches adjust electrical stimulation based on abnormal levels of a single wound biomarker, failing to accurately assess the overall wound condition and thus hinder precise feedback-based electrical stimulation adjustments. Therefore, there is an urgent need for a treatment protocol capable of real-time monitoring and overall wound condition assessment, enabling precise closed-loop electrical stimulation therapy. Summary of the Invention

[0005] This invention is proposed to solve the above-mentioned problems. The purpose of this invention is to provide a system for in-situ monitoring and feedback electrostimulation therapy of diabetic wounds. By detecting the electrochemical-physical parameters of the wound and applying feedback electrostimulation, the system accelerates wound healing. This invention enables remote medical care, creates a new model of outpatient home treatment, and speeds up the wound recovery of patients, with broad prospects for promotion and application. Attached Figure Description

[0006] Figure 1 This is a schematic diagram of the structure of the in-situ monitoring and feedback electrical stimulation therapy system for diabetic wounds provided by the present invention;

[0007] Figure 2 This is a system block diagram of the in-situ monitoring and feedback electrical stimulation therapy system for diabetic wounds provided by the present invention.

[0008] Figure 3 This is a schematic diagram of the in-situ monitoring and feedback electrical stimulation treatment method provided by the present invention;

[0009] Figure 4 This is a diagram of the smartphone application software interface provided by the present invention;

[0010] Figure 5 This is a schematic diagram of the functions of the smartphone software program;

[0011] Figure 6 This is a schematic diagram of the host computer processing module of the present invention. Detailed Implementation

[0012] The embodiments, features, and aspects of this disclosure will be described in detail below with reference to the accompanying drawings, but this is not intended to limit the invention. Based on any embodiment extended from the embodiments of this invention, all other embodiments obtained by those skilled in the art without inventive effort are within the scope of protection of this invention. The same reference numerals in the drawings denote the same or functionally similar elements. Although various aspects of the embodiments are shown in the drawings, they are not necessarily drawn to scale unless specifically indicated otherwise.

[0013] A system for in-situ monitoring and feedback electrical stimulation therapy of diabetic wounds, the system comprising:

[0014] A flexible multi-channel electrode array is attached to the user's target area.

[0015] The wound detection and treatment circuit, connected to a flexible multi-channel electrode array, has the functions of detecting the content of biomarkers in wound exudate, outputting electrical stimulation, and wireless communication.

[0016] The host computer processing module determines the degree of wound damage by analyzing the concentrations of three metabolites: glucose, lactic acid, and uric acid, thus obtaining a comprehensive wound damage coefficient D; it calculates a calibration coefficient M based on pH and temperature; and it uses an electrical stimulation correction value I. s Based on the comprehensive wound injury coefficient D and the calibration coefficient M, the personalized electrical stimulation intensity I is determined. r ; issue a power stimulation command to generate electrical stimulation output;

[0017] The wound detection and treatment circuit includes: circuit substrate 1-1, microcontroller 1-2, power supply module 1-3, Bluetooth module 1-4, electrochemical detection module 1-5, electrostimulation output module 1-6, and physical detection module 1-7;

[0018] The electrochemical detection module 1-5 includes a first potentiostat module 1-5-1, a second potentiostat module 1-5-2, and a third potentiostat module 1-5-3; the physical detection module 1-7 includes a temperature detection module 1-7-1 and a pH detection module 1-7-2.

[0019] The flexible multi-channel electrode array includes: counter electrode 2-1, first working electrode 2-2, second working electrode 2-3, third working electrode 2-4, reference electrode 2-5, positive electrical stimulation electrode 2-6, negative electrical stimulation electrode 2-7, pH sensing electrode 2-8, and temperature sensing electrode 2-9.

[0020] Furthermore, the flexible multichannel electrode array is attached to the surface of the user's wound, and the content of electrochemical-physical markers at the wound site is obtained by modifying the electrodes thereon.

[0021] The first working electrode 2-2, the counter electrode 2-1, and the reference electrode 2-5 together form the glucose sensing electrode; the second working electrode 2-3, the counter electrode 2-1, and the reference electrode 2-5 together form the lactic acid sensing electrode; the third working electrode 2-4, the counter electrode 2-1, and the reference electrode 2-5 together form the uric acid sensing electrode; the pH sensing electrode 2-8 is used for pH sensing; the temperature sensing electrode 2-9 is used for temperature sensing; and the positive electrical stimulation electrode 2-6 and the negative electrical stimulation electrode 2-7 are used for surface electrical stimulation.

[0022] The enzyme-based working electrode consists of glucose, lactate, and uric acid sensing electrodes, and its multilayer composite structure is designed as follows (e.g.) Figure 3 As shown):

[0023] 1. Substrate support layer: Polyimide flexible substrate (first layer), providing mechanical flexibility and insulation properties;

[0024] 2. Conductive layer: The conductive copper layer (second layer) and the screen-printed carbon paste 2-4-1 (third layer) form a three-dimensional conductive network;

[0025] 3. Sensing functional layer: Prussian blue mediator modified layer 2-4-2 (fourth layer) was constructed by electrodeposition. Then, biorecognition elements were fixed by layer-by-layer self-assembly technology. The fifth layer was loaded with glucose oxidase (GOx), lactate oxidase (LOx) and uricase (UOx) to form enzyme sensing layer 2-4-3, so as to realize the specific detection of corresponding metabolites.

[0026] 4. Protective layer: Glutaraldehyde crosslinking agent 2-4-4 (sixth layer) and chitosan biocompatible coating 2-4-5 (seventh layer) synergistically enhance enzyme activity stability and resistance to biofouling.

[0027] In terms of fabrication process, the substrate structure (1-3 layers) is realized by flexible printed circuit board (FPCB) micromachining and screen printing carbon electrode process, while the functional modification layers (4-7 layers) are constructed layer by layer through biochemical modification techniques such as electrochemical deposition, enzyme immobilization and biomolecular cross-linking.

[0028] A polyaniline-modified working electrode was prepared by performing 60 potential cycles at a scan rate of 100 mV / s on the working electrode in an electrolyte containing 1 M HCl and 100 mM aniline using cyclic voltammetry. The electrode was then applied to pH sensing research.

[0029] Furthermore, the electrical stimulation intensity correction process is as follows: electrical stimulation is applied to the wound site using the positive stimulation electrodes 2-6 and the negative stimulation electrodes 2-7, with the intensity starting from 0 and gradually increasing in increments of 0.1 mA. The electrical stimulation value perceived by the user is recorded as the electrical stimulation correction value I. s .

[0030] Furthermore, I s It is a weak pulsed current used to activate the directional alignment of cells and accelerate the proliferation and differentiation of fibroblasts to speed up wound healing.

[0031] Furthermore, for detecting the content of biomarkers in wound exudate, the concentrations of three biomarkers—glucose, lactic acid, and uric acid—are obtained using an electrochemical chronoamperometry method. The degree of wound damage is determined based on the concentrations of these three biomarkers. When one biomarker is above the normal value, it is classified as mild damage; when two biomarkers are above the normal value, it is classified as moderate damage; and when all three biomarkers are above the normal value, it is classified as severe damage. The comprehensive damage coefficient U is determined based on the degree of damage, and U is determined by the following formula:

[0032]

[0033] The specific value of the damage comprehensive coefficient should be selected based on the doctor's advice and the stage of wound healing.

[0034] Furthermore, the specific formula for calculating the calibration coefficient M is as follows:

[0035]

[0036] Among them, AC pH AC represents the average pH value at the wound site. T AC represents the average temperature at the wound site. pH＝6 =6, AC pH＝9 =9; AC T＝40 =40, AC T＝28 =28; M pH and M TThese represent the deviations of the pH and temperature values ​​at the user's wound site from normal values, indicating that wound damage varies between individuals.

[0037] Furthermore, temperature and pH are positively correlated with wound bed healing, reflecting the progress of wound bed healing. The calculation formula is as follows:

[0038]

[0039] C pH 'The effective pH value collected, C' T ' represents the effective temperature value collected, and N represents the number of data points per unit time.

[0040] Furthermore, the personalized electrical stimulation intensity I is combined with the wound injury status. r The formula is:

[0041] I r =I s ·(1+U)·(1+M pH )·(1+M T )#(1-6)

[0042] Among them, I r This indicates the personalized electrical stimulation intensity, i.e., the output electrical stimulation; as the wound gradually heals, the various indicators of the wound exudate gradually return to normal, I r Gradually towards I s As the patient gets closer, the electrical stimulation gradually decreases, and the changes in electrical stimulation are consistent with the changing trends in treatment strategies during the wound healing stage.

[0043] For the wireless communication function, i.e., the host computer processing module 3, such as Figure 6 As shown, a modular architecture design is adopted, which includes the following core functional units:

[0044] 1. Patient record management unit 3-1: Stores structured data such as patient age, gender, and medical history;

[0045] 2. Wound dynamic monitoring unit 3-2: Based on multi-sensor fusion technology, it collects wound microenvironment parameters (temperature, pH value, glucose / lactic acid / uric acid content) in real time;

[0046] 3. Electrical stimulation control unit 3-3: Provides a visual parameter configuration interface for pulse width, current intensity, and frequency. Commands are transmitted to the flexible electrode array via the SPI bus.

[0047] 4. Intelligent communication unit 3-4: can send information to the mobile phones or computer terminals of patients' family members and doctors.

[0048] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Any modifications, alterations, substitutions, or variations made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention shall fall within the protection scope defined by the claims of the present invention.

Claims

1. A system for in-situ monitoring and feedback electrical stimulation therapy of diabetic wounds, characterized in that, The system includes: A flexible multi-channel electrode array is attached to the user's target area. The wound detection and treatment circuit, connected to a flexible multi-channel electrode array, has the functions of detecting the content of biomarkers in wound exudate, outputting electrical stimulation, and wireless communication. The host computer processing module determines the degree of wound damage by analyzing the concentrations of three metabolites: glucose, lactic acid, and uric acid, and obtains the comprehensive wound damage coefficient U; it calculates the calibration coefficient M based on pH and temperature; and it uses the electrical stimulation correction value I. s Based on the comprehensive wound injury coefficient U and the calibration coefficient M, the personalized electrical stimulation intensity I is determined. r ; issue a power stimulation command to generate electrical stimulation output; The wound detection and treatment circuit includes: a circuit substrate (1-1), a microcontroller (1-2), a power supply module (1-3), a Bluetooth module (1-4), an electrochemical detection module (1-5), an electrical stimulation output module (1-6), and a physical detection module (1-7); The flexible multi-channel electrode array includes: counter electrode (2-1), first working electrode (2-2), second working electrode (2-3), third working electrode (2-4), reference electrode (2-5), positive electrical stimulation electrode (2-6), negative electrical stimulation electrode (2-7), pH sensing electrode (2-8), and temperature sensing electrode (2-9). The electrical stimulation intensity correction process is as follows: Electrical stimulation is applied to the wound site using the positive electrode (2-6) and the negative electrode (2-7). The intensity starts from 0 and gradually increases in increments of 0.1 mA. The lowest electrical stimulation value that the user can perceive is recorded as the electrical stimulation correction value I. s ; The concentrations of three markers—glucose, lactic acid, and uric acid—were obtained using an electrochemical chronoamperometry method. The severity of wound damage was assessed based on these concentrations. A mild injury was indicated by one marker being above the normal value; a moderate injury by two markers; and a severe injury by all three. A comprehensive damage coefficient U was determined based on the severity of the injury, and U was calculated using the following formula: The specific value of the damage assessment factor should be selected based on the doctor's advice and the stage of wound healing; The specific formula for calculating the calibration coefficient M is as follows: Among them, AC pH AC represents the average pH value at the wound site. T AC represents the average temperature at the wound site. pH＝6 =6, AC pH＝9 =9; AC T＝40 =40, AC T＝28 =28; M pH and M T These represent the deviations of the pH and temperature values ​​at the user's wound site from normal values, and the differences in wound damage between different individuals; Temperature and pH are positively correlated with wound bed healing, reflecting the progress of wound bed healing. The calculation formula is as follows: C pH 'The effective pH value collected, C' T ' represents the effective temperature value collected, and N represents the number of data points per unit time. Personalized electrical stimulation intensity I based on wound injury status r The formula is: I r =I s ·(1+U)·(1+M pH )·(1+M T ) (1-6) Among them, I r This indicates the intensity of personalized electrical stimulation. As the wound gradually heals and the various indicators of the wound exudate gradually return to normal, I... r Gradually towards I s As the patient gets closer, the electrical stimulation gradually decreases, and the changes in electrical stimulation are consistent with the changing trends in treatment strategies during the wound healing stage.

2. The system for in-situ monitoring and feedback electrical stimulation therapy of diabetic wounds according to claim 1, characterized in that, The flexible multichannel electrode array is attached to the surface of the user's wound, and the content of electrochemical-physical markers at the wound site is obtained by modifying electrodes on it. The first working electrode (2-2), the counter electrode (2-1), and the reference electrode (2-5) together constitute the glucose sensing electrode; The second working electrode (2-3), the counter electrode (2-1), and the reference electrode (2-5) together constitute the lactic acid sensing electrode; The third working electrode (2-4), the counter electrode (2-1), and the reference electrode (2-5) together constitute the uric acid sensing electrode; pH sensing electrode (2-8) is used for pH sensing; temperature sensing electrode (2-9) is used for temperature sensing; positive electrical stimulation electrode (2-6) and negative electrical stimulation electrode (2-7) are used for surface electrical stimulation.

3. The system for in-situ monitoring and feedback electrical stimulation therapy of diabetic wounds according to claim 1, characterized in that, I s It is a weak pulsed current used to activate the directional alignment of cells and accelerate the proliferation and differentiation of fibroblasts to speed up wound healing.

4. The system for in-situ monitoring and feedback electrical stimulation therapy of diabetic wounds according to claim 1, characterized in that, The host computer processing module displays various parameter data and electrical stimulation output intensity in real time.

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