Completely integrated miniature wireless wearable patch system

Abstract

The invention relates to the technical field of wearable medical equipment, in particular to a completely integrated miniature wireless wearable patch system which is composed of a wound detection and treatment circuit, a flexible multi-channel electrode array and an upper computer processing module and has wound in-situ detection and electrical stimulation treatment functions. The electrode array comprises a glucose sensing electrode, a lactic acid sensing electrode, a uric acid sensing electrode, a pH sensing electrode, a temperature sensing electrode and an electrical stimulation electrode. The wound detection and treatment circuit carries out instruction sending and data interaction through the Bluetooth module, carries out real-time in-situ measurement on wound exudate, processes received electrochemical signals and physical signals, obtains personalized electrical stimulation intensity in combination with the current state of the wound, and outputs the personalized electrical stimulation intensity to the electrical stimulation electrode to promote wound healing. According to the system, a remote monitoring platform is provided for wound management, the wound state can be detected in situ in real time, electrical stimulation parameters can be adjusted in time, and a personalized electrical stimulation treatment scheme is provided.

Description

Technical Field

[0001] The present invention relates to the field of wound monitoring and treatment devices, and particularly to a personalized wound electrochemical monitoring and electrical stimulation system. Background Art

[0002] The wound healing process is generally divided into a hemostasis phase, an inflammation phase, a proliferation phase, and a remodeling phase. Under various factors, the wound may heal slowly or even stagnate, thus forming a chronic wound. Therefore, timely and effective wound management during the wound healing process is of great significance for reducing infection and accelerating wound healing. During each stage of the healing process, the chemical composition of wound exudate changes greatly, thus indicating the healing stage and even the presence of infection. For example, an increase in temperature is related to bacterial infection, and temperature changes can provide information on various factors related to wound bed healing, inflammation, and oxygenation; acidity indicates the healing state, the balance of protease activity, and the degree of extracellular matrix remodeling. In addition, an increase in the pH value in the wound environment may be a sign of infection; lactic acid is an important marker for the diagnosis of soft tissue infection and angiogenesis in diabetic foot ulcers; the glucose in wound exudate has a strong correlation with blood glucose and bacterial activity, providing important treatment guidance for the treatment of diabetic wounds.

[0003] Current wound treatment methods usually require surgery or surgical intervention, and the currently reported electrical stimulation devices usually require bulky equipment and wire connections. As an alternative treatment method, electrical stimulation has been proven to have a significant impact on the wound healing process, including stimulating the proliferation and differentiation of fibroblasts into myofibroblasts and collagen formation, keratinocyte migration, angiogenesis, and attracting macrophages.

[0004] However, most of the existing intelligent dressing patches adjust electrical stimulation treatment according to the abnormal level of a single wound biomarker, and cannot accurately evaluate the overall state of the wound and perform precise feedback electrical stimulation adjustment based on this. Therefore, there is an urgent need for a device that can monitor the wound state in real time and evaluate the overall state, so as to implement an accurate closed-loop electrical stimulation treatment plan. Summary of the Invention

[0005] The present invention is proposed to solve the above problems. The purpose of the present invention is to provide a system for in-situ monitoring and feedback electrical stimulation treatment of diabetic wounds, which can detect electrochemical-physical parameters at the wound site and apply electrical stimulation in a feedback manner to accelerate wound recovery; the method of the present invention can make medical treatment remote, create a new model of out-of-hospital home treatment, accelerate the wound healing speed of patients, and has broad prospects for popularization and application. Brief Description of the Drawings

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

[0007] Figure 2 It is the system block diagram of the in-situ monitoring and feedback electrical stimulation treatment system for diabetic wounds provided by the present invention;

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

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

[0010] Figure 5 It is the schematic diagram of the functions of this smartphone software program; Figure 6 It is the schematic diagram of the host computer processing module of the present invention. Detailed implementation manners

[0011] The following will describe in detail the embodiments, features and aspects of the present disclosure with reference to the accompanying drawings, but it does not limit the present invention. Any embodiment extended based on the embodiments of the present invention, without creative efforts, for all other embodiments obtained by those of ordinary skill in the art, falls within the scope of protection of the present invention. The same reference numerals in the drawings represent the same or functionally similar elements. Although various aspects of the embodiments are shown in the drawings, unless otherwise specified, the drawings do not have to be drawn to scale.

[0012] A system for in-situ monitoring and feedback electrical stimulation treatment of diabetic wounds, the system includes:

[0013] A flexible multi-channel electrode array, attached to the target site of the user;

[0014] A wound detection and treatment circuit, connected to the flexible multi-channel electrode array, having functions of detecting the content of wound exudate biomarkers, outputting electrical stimulation and wireless communication;

[0015] A host computer processing module, judging the degree of wound damage through the concentrations of three metabolites, glucose, lactic acid, and uric acid, to obtain the comprehensive wound damage coefficient D; calculating the calibration coefficient M through the pH value and temperature; correcting the electrical stimulation value I s , and determining the personalized electrical stimulation intensity I according to the comprehensive wound damage coefficient D and the calibration coefficient M r ; issuing an electrical stimulation instruction to generate an electrical stimulation output;

[0016] 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;

[0017] 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.

[0018] The flexible multi-channel electrode array includes: a counter electrode 2-1, a first working electrode 2-2, a second working electrode 2-3, a third working electrode 2-4, a reference electrode 2-5, an electrostimulation positive electrode 2-6, an electrostimulation negative electrode 2-7, a pH sensing electrode 2-8, and a temperature sensing electrode 2-9.

[0019] Furthermore, the flexible multi-channel electrode array is attached to the surface of the user's wound, and the contents of electrochemical-physical markers at the wound are obtained through the modified electrodes thereon;

[0020] Among them, the first working electrode 2-2, the counter electrode 2-1, and the reference electrode 2-5 together form a glucose sensing electrode; the second working electrode 2-3, the counter electrode 2-1, and the reference electrode 2-5 together form a lactate sensing electrode; the third working electrode 2-4, the counter electrode 2-1, and the reference electrode 2-5 together form a 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; the electrostimulation positive electrode 2-6 and the electrostimulation negative electrode 2-7 are used for surface electrostimulation.

[0021] The enzyme-based working electrode is composed of glucose, lactate, and uric acid sensing electrodes, and its multi-layer composite structure is designed as follows (as Figure 3 shown):

[0022] 1. Substrate support layer: Polyimide flexible substrate (the first layer), providing mechanical flexibility and insulation properties;

[0023] 2. Conductive layer: Conductive copper layer (the second layer) and screen-printed carbon paste 2-4-1 (the third layer), forming a three-dimensional conductive network;

[0024] 3. Sensing functional layer: Construct a Prussian blue mediator modification layer 2-4-2 (the fourth layer) by electrodeposition method, and then fix the biorecognition element by layer-by-layer self-assembly technology - the fifth layer is respectively loaded with glucose oxidase (GOx), lactate oxidase (LOx), and uricase (UOx) to form an enzyme sensing layer 2-4-3, realizing the specific detection of corresponding metabolites;

[0025] 4. Protective layer: Glutaraldehyde cross-linking agent 2-4-4 (the sixth layer) and chitosan biocompatible coating 2-4-5 (the seventh layer), synergistically improving the enzyme activity stability and anti-biofouling ability.

[0026] In terms of the preparation process, the substrate structure (1 - 3 layers) is realized by the micro - processing of flexible printed circuit boards (FPCB) and the screen - printing carbon electrode process, while the functional modification layer (4 - 7 layers) is constructed layer by layer through biochemical modification techniques such as electrochemical deposition, enzyme immobilization, and biomolecule cross - linking.

[0027] A polyaniline - modified working electrode was prepared by cyclic voltammetry by performing 60 potential cycles on the working electrode at a scanning rate of 100 mV / s in an electrolyte containing 1 M HCl and 100 mM aniline, and it was applied to pH sensing research.

[0028] Furthermore, the process of correcting the electrical stimulation intensity is as follows: for the wound area, electrical stimulation is applied to the electrical stimulation positive electrode 2 - 6 and the electrical stimulation negative electrode 2 - 7. The intensity starts from 0 and gradually increases in steps of 0.1 mA, and the electrical stimulation value that the user can feel is recorded as the electrical stimulation correction value I. s 。

[0029] Furthermore, I s is a weak pulsed current, which is used to activate the directional arrangement of cells, accelerate the proliferation and differentiation ability of fibroblasts to accelerate wound healing.

[0030] Furthermore, for detecting the content of wound exudate biomarkers, the concentrations of three biomarkers, glucose, lactate, and uric acid, are obtained by electrochemical detection chronoamperometry. The degree of wound damage is judged according to the concentrations of the three biomarkers. When one index is higher than the normal value, it is marked as mild damage; when two indexes are higher than the normal value, it is marked as moderate damage; when three indexes are higher than the normal value, it is marked as severe damage. According to the degree of damage, the comprehensive damage coefficient U is determined. The comprehensive damage coefficient U is determined by the following formula:

[0031]

[0032] The specific value of the comprehensive damage coefficient is selected according to the doctor's advice and combined with the wound healing stage.

[0033] Furthermore, the specific calculation formula for the calibration coefficient M is:.

[0034]

[0035] Among them, AC pH is the average pH value at the wound, AC T is the average temperature value at the wound, AC pH＝6 = 6, AC pH＝9 = 9; AC T＝40 = 40, AC T＝28 = 28; M pH and M TThey respectively represent the deviations between the pH value and temperature at the user's wound and the normal values, and there are differences in wound injuries among different individuals.

[0036] Furthermore, temperature, pH value and wound bed healing are positively correlated, reflecting the progress of wound bed healing. The calculation formula is:

[0037]

[0038] C pH ' is the effective pH value collected, and C T ' is the effective temperature value collected, and N is the number of data points per unit time.

[0039] Furthermore, the personalized electrical stimulation intensity I combined with the wound injury status r The formula is:

[0040] I r =I s ·(1 + U)·(1 + M pH )·(1 + M T )#(1 - 6)

[0041] Among them, I r represents the personalized electrical stimulation intensity, that is, the output electrical stimulation; when the wound gradually repairs and the indicators of wound exudate gradually return to normal, I r gradually approaches I s , the electrical stimulation gradually decreases, and the change of electrical stimulation is consistent with the change trend of the treatment strategy in the wound healing stage.

[0042] For the wireless communication function, that is, the host computer processing module 3, as Figure 6 shown, it adopts a modular architecture design and includes the following core functional units:

[0043] 1. Patient file management unit 3 - 1: Stores structured data such as patient age, gender, medical history, etc.;

[0044] 2. Wound surface dynamic monitoring unit 3 - 2: Based on multi - sensor fusion technology, it collects wound micro - environment parameters (temperature, pH value, glucose / lactic acid / uric acid content) in real - time;

[0045] 3. Electrical stimulation regulation unit 3 - 3: Provides a visual parameter configuration interface for pulse width, current intensity, and frequency, and the instructions are transmitted to the flexible electrode array through the SPI bus;

[0046] 4. Intelligent communication unit 3 - 4: Can send information to the mobile phones or computer terminals of the patient's family members and doctors.

[0047] The embodiments described above are only descriptions of the preferred embodiments of the present invention, and do not limit the scope of the present invention. Without departing from the design spirit of the present invention, various deformations, variations, modifications, and substitutions made by those of ordinary skill in the art to the technical solutions of the present invention shall fall within the protection scope determined by the claims of the present invention.

Claims

1. A system for in-situ monitoring and feedback electrical stimulation treatment of diabetic wounds, characterized in that: The system includes: A flexible multi-channel electrode array that is attached to the user’s target area; The wound detection and treatment circuit is connected to the flexible multi-channel electrode array and has the functions of detecting the biomarker content of wound exudate, outputting electrical stimulation and wireless communication; The host computer processing module determines the degree of wound damage by the concentration of three metabolites: glucose, lactic acid, and uric acid, and obtains the comprehensive coefficient of wound damage D; calculates the calibration coefficient M by pH value and temperature; and corrects the value I by electrical stimulation. s , according to the wound damage comprehensive coefficient D and calibration coefficient M, determine the personalized electrical stimulation intensity I r ; Issue electrical stimulation instructions to generate electrical stimulation output; The wound detection and treatment circuit comprises: 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 comprises: a counter electrode (2-1), a first working electrode (2-2), a second working electrode (2-3), a third working electrode (2-4), a reference electrode (2-5), an electrical stimulation positive electrode (2-6), an electrical stimulation negative electrode (2-7), a pH sensing electrode (2-8), and a temperature sensing electrode (2-9).

2. The in-situ monitoring and feedback electrical stimulation treatment system for diabetic wounds according to claim 1, characterized in that: The flexible multi-channel electrode array is attached to the wound surface of the user, and the content of electrochemical-physical markers at the wound is obtained through the modified electrodes thereon; The first working electrode (2-2), the counter electrode (2-1) and the reference electrode (2-5) together constitute a glucose sensing electrode; The second working electrode (2-3), the counter electrode (2-1) and the reference electrode (2-5) together constitute a lactic acid sensing electrode; The third working electrode (2-4), the counter electrode (2-1) and the reference electrode (2-5) together constitute a 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; the electrical stimulation positive electrode (2-6) and the electrical stimulation negative electrode (2-7) are used for surface electrical stimulation.

3. The in-situ monitoring and feedback electrical stimulation treatment system for diabetic wounds according to claim 2, characterized in that: The process of correcting the intensity of electrical stimulation is as follows: applying electrical stimulation to the wound affected area, the electrical stimulation positive electrode (2-6) and the electrical stimulation negative electrode (2-7), and gradually increasing the intensity from 0 to 0.1 mA step value, and recording the electrical stimulation value that the user can feel as the electrical stimulation correction value I s .

4. The in-situ monitoring and feedback electrical stimulation treatment system for diabetic wounds according to claim 3, characterized in that: I s It is a weak pulse current used to activate cell directional alignment, accelerate the proliferation and differentiation of fibroblasts to speed up wound recovery.

5. The in-situ monitoring and feedback electrical stimulation treatment system for diabetic wounds according to claim 1, characterized in that: The concentrations of three markers, glucose, lactic acid, and uric acid, were obtained by electrochemical detection chronoamperometry. The degree of wound injury was determined based on the concentrations of the three markers. When one indicator was higher than the normal value, it was marked as mild injury; when two indicators were higher than the normal value, it was marked as moderate injury; when three indicators were higher than the normal value, it was marked as severe injury. The comprehensive injury coefficient U was determined based on the degree of injury. The comprehensive injury coefficient U was determined by the following formula: The specific value of the comprehensive injury coefficient is selected based on the doctor's advice and the wound healing stage.

6. The in-situ monitoring and feedback electrical stimulation treatment system for diabetic wounds according to claim 1, characterized in that: The specific calculation formula of the calibration coefficient M is: Among them, AC pH is the average pH value of the wound, AC T is the average temperature of the wound, AC pH＝6 =6, AC pH＝9 =9;AC T＝40 =40, AC T＝28 =28;M pH and M T They represent the deviation between the pH value and temperature at the user's wound and the normal values, respectively. The wound damage varies between different individuals.

7. The in-situ monitoring and feedback electrical stimulation treatment system for diabetic wounds according to claim 4, characterized in that: Temperature and pH value are positively correlated with wound bed healing, reflecting the progress of wound bed healing. The calculation formula is: C pH ' is the effective pH value collected, G T ' is the effective temperature value collected, and N is the number of data points per unit time.

8. The in-situ monitoring and feedback electrical stimulation treatment system for diabetic wounds according to claim 5, characterized in that: Personalized electrical stimulation intensity based on wound damage status r The formula is: I r =I s ·(1+U)·(1+M pH )·(1+M T )#(1-6) Among them, I r Indicates the personalized electrical stimulation intensity. When the wound is gradually repaired, the various indicators of wound exudate gradually return to normal. r Gradually towards I s As the wound approaches, the electrical stimulation gradually decreases, and the change in electrical stimulation is consistent with the changing trend of the treatment strategy during the wound healing stage.

9. The in-situ monitoring and feedback electrical stimulation treatment system for 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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