Manufacturing process of wearable oxygen free radical real-time dynamic monitor

Abstract

The invention relates to the technical field of oxygen free radical detection, in particular to a wearable oxygen free radical monitor and a manufacturing process thereof. The wearable oxygen free radical monitor is characterized by comprising a shell, an oxygen free radical monitoring device and an oxygen free radical monitoring device, the monitoring probe comprises a substrate layer, a first electrode, a second electrode, a first reagent layer and a second reagent layer, the first reagent layer is made of lauric acid modified superoxide dismutase; the second reagent layer is made of a perfluorosulfonic acid polymer, the interface part of the first electrode is connected with the circuit module, and the interface part of the second electrode is connected with the circuit module; the pilot needle is detachably connected to the connecting hole, the pilot needle comprises a holding part and a needle body connected to the holding part, and a groove is formed in the lower portion of the needle body. By means of the structural improvement, the manufactured monitor can dynamically monitor the oxygen free radical change condition of the human body in real time under the condition that blood sampling is not needed.

Description

Technical Field

[0001] The present invention relates to the technical field of oxygen free radical detection, and in particular to a manufacturing process of a wearable oxygen free radical monitor. Background Art

[0002] During oxygen metabolism in the human body, harmful oxygen or free radicals called reactive oxygen species are produced as byproducts. These oxygen free radicals have various adverse effects on the human body. For example, they produce lipid peroxides inside human tissues. Lipid peroxidation is a physiological process that occurs continuously in cell membranes, which leads to oxidative damage to unsaturated lipids.

[0003] In the existing technology, malondialdehyde is one of the measurement methods that can determine the degree of lipid peroxidation. The methods mainly use the HLPC method and the TBARS method. The HLPC method requires the use of expensive equipment to implement, and the TBARS method requires relatively complex sample pretreatment. Moreover, in the above detection methods, blood sampling is required for each test, which has low detection efficiency. The process of transferring the blood sample to the instrument is easily affected by the accuracy of the test. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide a wearable oxygen free radical real-time dynamic monitor and its manufacturing process, so that the monitor can monitor the changes of oxygen free radicals in the human body in real time without blood sampling.

[0005] In order to solve the above technical problems, the technical solution adopted by the present invention is: Wearable oxygen free radical monitor, including: A housing, wherein a circuit module is disposed in the housing, the housing is provided with a through connection hole, and a lower portion of the housing is provided with an adhesive material layer for adhering to the skin; A monitoring probe, comprising a base layer, a first electrode, a second electrode, a first reagent layer and a second reagent layer; the base layer comprises an elongated needle implant portion and an interface portion connected to one end of the needle implant portion, the width of the interface portion being greater than the needle implant portion; the first electrode is connected to a first side of the base layer, the first electrode covers a partial area of the needle implant portion and the interface portion, the second electrode is connected to a second side of the base layer, the second electrode covers a partial area of the needle implant portion and the interface portion; the first reagent layer is arranged on a first side of the needle implant portion area of the first electrode, and the second reagent layer is arranged on a second side of the needle implant portion area of the second electrode; the material of the first reagent layer is lauric acid-modified superoxide dismutase; the material of the second reagent layer is perfluorosulfonic acid polymer, the interface portion of the first electrode is connected to the circuit module, and the interface portion of the second electrode is connected to the circuit module; The guide needle is detachably connected to the connecting hole. The guide needle includes a gripping portion and a needle body connected to the gripping portion. A groove is provided at the lower portion of the needle body. In the first state, the monitoring probe is connected to the groove. In the second state, the guide needle cooperates with the implanted needle portion of the monitoring probe to insert into the skin tissue. The guide needle is pulled out from the connecting hole in reverse, so that the implanted needle portion of the monitoring probe remains in the skin tissue.

[0006] Furthermore, in the above-mentioned wearable oxygen free radical monitor structure, the base layer is made of polyethylene terephthalate.

[0007] Furthermore, in the above-mentioned wearable oxygen free radical monitor structure, the first electrode is made of gold.

[0008] Furthermore, in the above-mentioned wearable oxygen free radical monitor structure, the second electrode is made of silver.

[0009] Furthermore, the wearable oxygen free radical monitor structure further includes a protective cover. In the first state, the protective cover covers the needle body of the pilot needle.

[0010] Furthermore, in the above-mentioned wearable oxygen free radical monitor structure, the circuit module includes a main power supply circuit module, a switch circuit module, a power supply circuit module, a main control circuit module, a voltage signal processing module and a wireless communication module; The main power supply circuit module is electrically connected to the power circuit module through the switch circuit module; The power circuit module is electrically connected to the first electrode, the second electrode, the voltage signal processing module, the main control circuit module and the wireless communication module, respectively, and is used to transform and supply power to the first electrode, the second electrode, the voltage signal processing module, the main control circuit module and the wireless communication module respectively; The voltage signal processing module includes a voltage transmission unit, a voltage comparison unit and a reference signal unit. The voltage transmission unit is electrically connected to the first electrode and the second electrode and is used to transmit the sensing voltage. The voltage comparison unit is used to compare the sensing voltage with the reference voltage pre-stored in the reference signal unit to obtain a voltage difference signal. The main control circuit module is electrically connected to the switch circuit module, the voltage signal processing module and the wireless communication module respectively. The main control circuit module is used to perform analog-to-digital conversion on the voltage difference signal and transmit the digital signal to the wireless communication module. The main control circuit module is also used to control the periodic switching of the switch circuit. The wireless communication module is used to send digital signals to the terminal.

[0011] Furthermore, in the above-mentioned wearable oxygen free radical monitor structure, the wireless communication module is a Bluetooth module.

[0012] Furthermore, in the above-mentioned wearable oxygen free radical monitor structure, the base layer is provided with a through hole, a third electrode is provided on a first side of the through hole of the base layer, and the third electrode is connected to the second electrode through the through hole.

[0013] The present invention also relates to a manufacturing process of the wearable oxygen free radical monitor, comprising the following steps: Making housing and circuit module; Prepare a monitoring probe, prepare a base layer, respectively dispose a first electrode on a first side of the base layer, dispose a second electrode on a second side of the base layer, connect a first reagent layer to the first side of the first electrode via an adhesive, and connect a second reagent layer to the second side of the second electrode via an adhesive; Connect the monitoring probe to the needle body groove of the guide needle, connect the guide needle to the shell, fix the interface part of the monitoring probe to the shell, and electrically connect the power circuit module and the voltage transmission unit in the circuit module to the first electrode and the second electrode respectively.

[0014] The beneficial effects of the present invention are: 1. It is the first time that lauric acid-modified superoxide dismutase (LA-SOD) is used as an enzyme detection reagent, which is acid-resistant, alkali-resistant, and high-temperature resistant; 2. It has long-term stability, and lauric acid-modified superoxide dismutase is acid-resistant, alkali-resistant, high-temperature resistant, and has a long shelf life; 3. It can dynamically monitor changes in oxygen free radicals in a wearable manner and provide real-time clinical monitoring; 4. The detector is portable, compact, and lightweight; 5. It can provide rapid and instant dynamic monitoring. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 This is an exploded schematic diagram of the structure of a wearable oxygen free radical monitor according to a specific embodiment of the present invention; Figure 2 for Figure 1 A magnified view of part A; Figure 3 This is an exploded view of the structure of a monitoring probe of a wearable oxygen free radical monitor according to a specific embodiment of the present invention; Figure 4 This is a schematic planar structural diagram of a monitoring probe of a wearable oxygen free radical monitor according to a specific embodiment of the present invention; Figure 5 This is a schematic diagram of a circuit module of a wearable oxygen free radical monitor according to a specific embodiment of the present invention; Description of labels: 1. Shell; 11. Connection hole; 2. Monitoring probe; 21. Base layer; 22. First electrode; 23. Third electrode; 24. Second electrode; 26. First reagent layer; 27. Second reagent layer; 281. Needle implant; 282. Interface; 3. Guide needle; 31. Grip; 32. Needle body; 321. Groove; 4. Circuit module. DETAILED DESCRIPTION

[0016] To illustrate the technical content, achieved objectives and effects of the present invention in detail, the following description is given in conjunction with the embodiments and accompanying drawings.

[0017] Please refer to Figures 1 to 5 , a specific embodiment of the present invention relates to a wearable oxygen free radical monitor, comprising: A housing 1, wherein a circuit module 4 is disposed in the housing 1, the housing 1 is provided with a through-hole 11, and a layer of adhesive material for adhering to the skin is provided at the lower portion of the housing 1; The monitoring probe 2 includes a base layer 21, a first electrode 22, a second electrode 24, a first reagent layer 26 and a second reagent layer 27; the base layer 21 includes a long strip of implanted needle portion 281 and an interface portion 282 connected to one end of the implanted needle portion 281, and the width of the interface portion 282 is greater than that of the implanted needle portion 281; the first electrode 22 is connected to the first side of the base layer 21, and the first electrode 22 covers a portion of the implanted needle portion 281 and the interface portion 282; the second electrode 24 is connected to the second side of the base layer 21, The second electrode 24 covers a portion of the needle implant portion 281 and the interface portion 282; the first reagent layer 26 is provided on a first side of the needle implant portion 281 of the first electrode 22, and the second reagent layer 27 is provided on a second side of the needle implant portion 281 of the second electrode 24; the material of the first reagent layer 26 is lauric acid-modified superoxide dismutase; the material of the second reagent layer 27 is perfluorosulfonic acid polymer; the interface portion 282 of the first electrode 22 is connected to the circuit module 4, and the interface portion 282 of the second electrode 24 is connected to the circuit module 4; The guide needle 3 is detachably connected to the connecting hole 11. The guide needle 3 includes a gripping portion 31 and a needle body 32 connected to the gripping portion 31. A groove 321 is provided at the lower portion of the needle body 32. In the first state, the monitoring probe 2 is connected to the groove 321. In the second state, the guide needle 3 cooperates with the implanting needle portion 281 of the monitoring probe 2 to be inserted into the skin tissue. The guide needle 3 is pulled out from the connecting hole 11 in reverse, so that the implanting needle portion 281 of the monitoring probe 2 remains in the skin tissue.

[0018] In the above embodiment, referring to Figure 1 The connecting hole 11 is a stepped countersunk hole, and the gripping portion 31 of the guide needle 3 is provided with a stepped mortise and tenon structure that cooperates with the countersunk hole, so that the guide needle 3 can only be pulled out from the side away from the needle body 32.

[0019] In the above embodiment, the method of using the wearable oxygen free radical monitor is as follows. Before use, the guide needle 3 and the monitoring probe 2 are in a first state connection relationship, and the guide needle 3 is connected to the connection hole 11 of the shell 1 to form a whole. When in use, the lower part of the shell 1 is pressed to adhere to the skin surface, so that the guide needle 3 cooperates with the needle implantation part 281 of the monitoring probe 2 to insert into the skin tissue. In order to ensure continuous and stable wearing, medical tape can be applied to the shell 1 to fix the shell 1 on the skin to prevent it from falling off. Then the guide needle 3 is pulled out in reverse, and the needle implantation part 281 of the monitoring probe 2 remains in the skin tissue, that is, the second state. At this time, the first reagent layer 26 and the second reagent layer 27 can be used to generate voltage changes in the first electrode 22 and the second electrode 24 according to the electrochemical action of oxygen free radicals. The voltage change signal can be obtained in real time through the circuit module 4, thereby achieving the purpose of real-time monitoring of oxygen free radicals.

[0020] The working principle of oxygen free radical detection by the first reagent layer and the second reagent layer is as follows: During enzymatic electron transfer, redox reactions, or under the influence of light and heat, covalent bonds in compound molecules undergo homolytic cleavage, forming atoms or groups with unpaired electrons, which become free radicals. Superoxide dismutase (SOD) has the ability to scavenge oxygen free radicals (O2-·). It catalyzes the dismutation reaction of oxygen free radicals (O2-·) to produce oxygen and hydrogen peroxide. Hydrogen peroxide undergoes an electrochemical reaction at the working electrode, causing electron transfer and generating a current signal. The current is proportional to the concentration of oxygen free radicals. By detecting the current, the concentration of oxygen free radicals can be obtained. The specific reaction equation is as follows: Specifically, the material of the first reagent layer 26 is lauric acid-modified superoxide dismutase (LA-SOD) combined with a certain amount of adhesive. The activity of lauric acid-modified superoxide dismutase is ≥40,000 U / mg and the purity is ≥98%. The material of the second reagent layer 27 is Nafion membrane (perfluorosulfonic acid polymer). This membrane can repel negatively charged interferences (such as ascorbic acid and uric acid) to ensure that the signal collected by the electrode is generated by the dismutation reaction. The function of this layer is to limit the penetration of interferences (such as ascorbic acid and uric acid) and improve specificity.

[0021] Specifically, since the probe needs to be inserted into the human subcutaneous tissue, to reduce discomfort after insertion while ensuring sufficient strength, the width of the needle portion 281 is 0.3 mm. To ensure that the probe can contact the body's interstitial fluid after insertion, the length of the probe needle portion 281 is 7 mm. Electrons generated by the electrochemical reaction need to be transferred to the circuit module 4 through the first electrode 22 and the second electrode 24. To ensure the stability of the printed circuit board connection, the width of the interface portion 282 is 2 mm and the length is 6 mm.

[0022] As a preferred embodiment, the base layer 21 is made of polyethylene terephthalate, which has good mechanical properties, chemical stability, and dimensional stability, and can provide stable support for the electrode layer and the reagent layer. In addition, the material is soft and has little foreign body sensation when inserted into human tissue.

[0023] In a preferred embodiment, the first electrode 22 is made of gold. It is attached to the base layer 21 via electroplating and has a thickness of 0.05 mm. Compared to other materials, gold is physically and chemically stable and will not dissolve due to prolonged contact with human tissue fluid, thereby posing a risk to the human body.

[0024] In a preferred embodiment, the second electrode 24 is made of silver. This electrode, serving as the sensor's reference electrode, is made of metallic silver (Ag) and is deposited beneath the base layer 21 via electroplating. It has a thickness of 0.05 mm. The two electrodes, located on the upper and lower surfaces of the base layer 21, reduce the cross-sectional area of the sensor implanted in the skin, minimizing the size of the wound.

[0025] As a preferred embodiment, a protective cover is further included. In the first state, the protective cover covers the needle body 32 of the guide needle 3 .

[0026] As a preferred embodiment, the circuit module 4 includes a main power supply circuit module 4, a switch circuit module 4, a power circuit module 4, a main control circuit module 4, a voltage signal processing module and a wireless communication module; The main power supply circuit module 4 is electrically connected to the power supply circuit module 4 through the switch circuit module 4; the function of the main power supply circuit module 4 is to control the battery to power the circuit board. When the guide needle 3 is pulled out, the battery is connected, and the first electrode 22 and the second electrode 24 are in working state.

[0027] The power supply circuit module 4 is electrically connected to the first electrode 22, the second electrode 24, the voltage signal processing module, the main control circuit module 4 and the wireless communication module, respectively, and is used to transform and supply power to the first electrode 22, the second electrode 24, the voltage signal processing module, the main control circuit module 4 and the wireless communication module respectively; the power supply circuit also includes modules such as voltage reduction, current limiting, and voltage stabilization, which are convenient for providing stable and required voltage to each module unit.

[0028] The voltage signal processing module includes a voltage transmission unit, a voltage comparison unit, and a reference signal unit. The voltage transmission unit is electrically connected to the first electrode 22 and the second electrode 24 and is used to transmit the sensing voltage. The voltage comparison unit is used to compare the sensing voltage with the reference voltage pre-stored in the reference signal unit to obtain a voltage difference signal. The main control circuit module 4 is electrically connected to the switch circuit module 4, the voltage signal processing module and the wireless communication module respectively. The main control circuit module 4 is used to perform analog-to-digital conversion on the voltage difference signal and transmit the digital signal to the wireless communication module. The main control circuit module 4 is also used to control the periodic switching of the switch circuit. For example, the main control circuit module 4 controls the switch circuit module 4 to supply power to the power circuit module 4 every 5 minutes according to the sampling period. At this time, the monitoring probe 2 undergoes an electrochemical reaction, and the generated signal is amplified by the voltage transmission unit, filtered by the voltage comparison unit, and processed to obtain a signal that is transmitted to the main control circuit module 4; The wireless communication module is used to send digital signals to the terminal.

[0029] As a preferred embodiment, the wireless communication module is a Bluetooth module.

[0030] In the above embodiment, taking the mobile phone as an example, after the instrument is worn, the battery of the main power supply circuit module 4 supplies power to the circuit module 4. At this time, the mobile phone is used to open the APP and pair with the instrument using Bluetooth. In this way, the current signal collected by the instrument can be transmitted to the mobile phone, and then the mobile phone performs the corresponding calculations and finally displays it through the APP. For example, the Bluetooth module connects to the mobile phone and transmits data to the mobile phone at a time period of 5 minutes. When disconnected from the mobile phone, it can notify the main control circuit module 4 to temporarily store the data, and when the connection is restored next time, the data will be packaged and transmitted as a whole.

[0031] As a preferred embodiment, the base layer 21 is provided with a through hole, and a third electrode 23 is provided on a first side of the through hole of the base layer 21 . The third electrode 23 is connected to the second electrode 24 through the through hole.

[0032] In the above embodiment, the second electrode 24 is connected to the third electrode 23 through a through hole, so that the reference electrode is located on the same surface of the base layer 21, which is convenient for connection with the circuit board to achieve data analysis.

[0033] After receiving the data, the mobile phone port can display the concentration of oxygen free radicals in real time, perform data statistics and storage, and establish an oxygen free radical concentration curve.

[0034] The present invention also relates to a manufacturing process of the wearable oxygen free radical monitor, comprising the following steps: Manufacturing the housing 1 and the circuit module 4; A monitoring probe 2 is prepared by preparing a base layer 21, and a first electrode 22 is disposed on a first side of the base layer 21, and a second electrode 24 is disposed on a second side of the base layer 21, and a first reagent layer 26 is connected to the first side of the first electrode 22 by an adhesive, and a second reagent layer 27 is connected to the second side of the second electrode 24 by an adhesive; Connect the monitoring probe 2 to the groove 321 of the needle body 32 of the guide needle 3, connect the guide needle 3 to the shell 1, fix the interface part 282 of the monitoring probe 2 to the shell 1, and electrically connect the power circuit module 4 and the voltage transmission unit in the circuit module 4 to the first electrode 22 and the second electrode 24 respectively.

[0035] Application scenarios of the wearable oxygen free radical monitor involved in the present invention may include: 1. Scientific research Mitochondrial function research and antioxidant drug screening.

[0036] 2. Clinical Ischemia-reperfusion injury monitoring, inflammatory response monitoring, and oxidative stress research and monitoring. Through interdisciplinary collaboration (materials science, microelectronics, and biomedical engineering), oxygen free radical monitors can achieve dynamic and highly sensitive detection of reactive oxygen species, providing a key tool for oxidative stress research.

[0037] 3. Industry Assessment of oxidative stability of foods.

[0038] The above descriptions are merely embodiments of the present invention and are not intended to limit the patent scope of the present invention. Any equivalent transformations made using the contents of the present invention's description and drawings, or directly or indirectly applied in related technical fields, are also included in the patent protection scope of the present invention.

Claims

1. Wearable oxygen free radical monitor, characterized in that: include: A housing, wherein a circuit module is disposed in the housing, the housing is provided with a through connection hole, and a lower portion of the housing is provided with an adhesive material layer for adhering to the skin; A monitoring probe, comprising a base layer, a first electrode, a second electrode, a first reagent layer and a second reagent layer; the base layer comprises an elongated needle implant portion and an interface portion connected to one end of the needle implant portion, the width of the interface portion being greater than the needle implant portion; the first electrode is connected to a first side of the base layer, the first electrode covers a partial area of the needle implant portion and the interface portion, the second electrode is connected to a second side of the base layer, the second electrode covers a partial area of the needle implant portion and the interface portion; the first reagent layer is arranged on a first side of the needle implant portion area of the first electrode, and the second reagent layer is arranged on a second side of the needle implant portion area of the second electrode; the material of the first reagent layer is lauric acid-modified superoxide dismutase; the material of the second reagent layer is perfluorosulfonic acid polymer, the interface portion of the first electrode is connected to the circuit module, and the interface portion of the second electrode is connected to the circuit module; The guide needle is detachably connected to the connecting hole. The guide needle includes a gripping portion and a needle body connected to the gripping portion. A groove is provided at the lower portion of the needle body. In the first state, the monitoring probe is connected to the groove. In the second state, the guide needle cooperates with the implanted needle portion of the monitoring probe to insert into the skin tissue. The guide needle is pulled out from the connecting hole in reverse, so that the implanted needle portion of the monitoring probe remains in the skin tissue.

2. The wearable oxygen free radical monitor according to claim 1, characterized in that: The material of the base layer is polyethylene terephthalate.

3. The wearable oxygen free radical monitor according to claim 1, characterized in that: The material of the first electrode is gold.

4. The wearable oxygen free radical monitor according to claim 1, characterized in that: The second electrode is made of silver.

5. The wearable oxygen free radical monitor according to claim 1, characterized in that: It also includes a protective cover, which covers the needle body of the guide needle in a first state.

6. The wearable oxygen free radical monitor according to claim 1, characterized in that: The circuit module includes a main power supply circuit module, a switch circuit module, a power circuit module, a main control circuit module, a voltage signal processing module and a wireless communication module; The main power supply circuit module is electrically connected to the power circuit module through the switch circuit module; The power circuit module is electrically connected to the first electrode, the second electrode, the voltage signal processing module, the main control circuit module and the wireless communication module, respectively, and is used to transform and supply power to the first electrode, the second electrode, the voltage signal processing module, the main control circuit module and the wireless communication module respectively; The voltage signal processing module includes a voltage transmission unit, a voltage comparison unit and a reference signal unit. The voltage transmission unit is electrically connected to the first electrode and the second electrode and is used to transmit the sensing voltage. The voltage comparison unit is used to compare the sensing voltage with the reference voltage pre-stored in the reference signal unit to obtain a voltage difference signal. The main control circuit module is electrically connected to the switch circuit module, the voltage signal processing module and the wireless communication module respectively. The main control circuit module is used to perform analog-to-digital conversion on the voltage difference signal and transmit the digital signal to the wireless communication module. The main control circuit module is also used to control the periodic switching of the switch circuit. The wireless communication module is used to send digital signals to the terminal.

7. The wearable oxygen free radical monitor according to claim 6, characterized in that: The wireless communication module is a Bluetooth module.

8. The wearable oxygen free radical monitor according to claim 1, characterized in that: The base layer is provided with a through hole, a third electrode is provided on a first side of the through hole of the base layer, and the third electrode is connected to the second electrode through the through hole.

9. The manufacturing process of the wearable oxygen free radical monitor according to any one of claims 1 to 8, characterized in that: The following steps are involved: Making housing and circuit module; Prepare a monitoring probe, prepare a base layer, respectively dispose a first electrode on a first side of the base layer, dispose a second electrode on a second side of the base layer, connect a first reagent layer to the first side of the first electrode via an adhesive, and connect a second reagent layer to the second side of the second electrode via an adhesive; Connect the monitoring probe to the needle body groove of the guide needle, connect the guide needle to the shell, fix the interface part of the monitoring probe to the shell, and electrically connect the power circuit module and the voltage transmission unit in the circuit module to the first electrode and the second electrode respectively.

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