Noninvasive oral glucometer

Abstract

The present invention is an oral glucometer comprising: a mounting part; the detection part is mounted in the mounting part and comprises a sensor coated with a glucose conversion layer, and the sensor is used for receiving saliva to be detected; the control part is electrically connected with the detection part and is used for detecting the glucose content value of the saliva received by the silicon-based sensor; the display part is used for displaying the glucose content value measured by the control part, the glucose conversion layer is used for converting glucose in the to-be-detected saliva into hydrogen ions, so that the hydrogen ions are captured by the sensor and converted into electric signals, the electric signals are input into the control part, and the display part is used for displaying the glucose content value measured by the control part. The control unit calculates a glucose content value on the basis of the electrical signal. The glucometer can detect the content of trace glucose in oral saliva so as to correspond to the blood glucose level of a testee, and is convenient to use and noninvasive.

Description

Technical Field

[0001] The invention relates to a blood sugar detection device, in particular to a non-invasive oral blood sugar meter for detecting glucose concentration based on saliva. Background Art

[0002] Early detection and management of diabetes are crucial for patients. Traditional methods of testing blood sugar require blood sampling, which takes a long time to test, causes trauma and pain to the human body, and easily increases infection and transmission routes. Some existing electronic blood sugar testers still belong to the category of invasive testing, and are complicated to operate and inconvenient to use. To this end, various non-invasive blood sugar testing methods and equipment have been developed.

[0003] Chinese invention patent 201910230348.2 discloses a non-invasive blood glucose detection method, which uses a model to design a simulation experiment and uses human metabolic heat measurement to calculate blood glucose values. However, this simulation calculation method is complicated and the detection results are inaccurate.

[0004] Chinese invention patent 202410680902.8 discloses a blood glucose detector and detection method based on Raman spectroscopy, which measures blood glucose by detecting the spectrum of the skin surface. However, the measurement error of this method is very different from the actual result, so it is rarely used in practice.

[0005] In addition, there is a saliva glucose test strip on the market. This product is a non-invasive blood sugar test strip based on colorimetry, with low detection sensitivity. It can only provide a certain warning effect for patients with severe excessive blood sugar, and its application is too narrow. In addition, this product is expensive. For people with high blood sugar, blood sugar needs to be measured multiple times a day, and the average cost per person is too high.

[0006] Saliva, as an oral fluid, contains a variety of substances, including inorganic ions, small organic molecules, lipids, proteins and various hormones. Saliva is easy to collect and non-invasive, and can be used as a biological sample for research and clinical practice. In both type 1 diabetes and type 2 diabetes, salivary glucose levels can reflect blood sugar levels. Therefore, diabetes can be monitored by detecting low concentrations of glucose in saliva. The normal glucose concentration in human blood is 2-30mmol / L, and the glucose concentration in saliva is 0.025-0.1mmol / L. The glucose content in the saliva of diabetic patients is significantly increased, generally greater than 0.4mmol / L.

[0007] By testing the patient's saliva glucose concentration, the patient's corresponding blood sugar value can be indirectly detected, and the blood sugar value can be measured in a non-invasive way. Therefore, it is feasible to use saliva to detect blood sugar.

[0008] However, compared with the glucose concentration in blood, the glucose concentration in saliva is very low, and it is difficult to directly detect the glucose content in saliva using existing technical means. Summary of the invention

[0009] The core technical problem to be solved by the present invention is to provide a non-invasive oral blood glucose meter capable of performing high-precision detection of extremely low concentrations of glucose in saliva.

[0010] To this end, the present invention proposes an oral blood glucose meter, which includes: a mounting portion; a detection portion installed in the mounting portion, the detection portion including a sensor coated with a glucose conversion layer, the sensor being used to receive saliva to be detected; a control portion electrically connected to the detection portion, the control portion being used to measure the glucose content value of the saliva received by the silicon-based sensor; and a display portion being used to display the glucose content value measured by the control portion, wherein the glucose conversion layer is used to convert the glucose in the saliva to be detected into hydrogen ions, so that the hydrogen ions are captured by the sensor and converted into electrical signals, the electrical signals are input into the control portion, and the control portion calculates the glucose content value based on the electrical signals.

[0011] Preferably, the sensor is a silicon-based sensor.

[0012] Preferably, the silicon-based sensor comprises a silicon-based substrate, an oxide layer formed on the silicon-based substrate, a semiconductor device formed on the oxide layer, and a modification layer formed on the semiconductor device, and the glucose conversion layer is coated on the modification layer.

[0013] Preferably, the semiconductor device is an ISFET field effect transistor, and the ISFET transistor includes a gate region, a drain region and a source region, wherein the gate region is formed on the oxide layer, and the drain region and the source region are formed at intervals along both sides of the gate region, and a sensitive layer is formed on the drain region and the source region.

[0014] Preferably, the drain region and the source region are formed on a silicon-based substrate.

[0015] Preferably, the oxide layer is a SiO2 layer.

[0016] Preferably, a trench is formed in the oxide layer, the gate region is arranged in the trench, and the drain region and the source region are arranged outside the oxide layer.

[0017] Preferably, the modified layer comprises a chemically modified polymer material having a selective permeability to hydrogen ions.

[0018] Preferably, the polymer material is a polyethyleneimine (PEI) derivative, polyacrylic acid (PAA), polymethacrylic acid (PMAA), polystyrene sulfonic acid (PSS) or polyparaphenylene vinylene (PPV) derivative.

[0019] Preferably, the sensitive layer comprises a metal oxide based semiconductor material.

[0020] Preferably, the metal oxide is zinc oxide (ZnO) nanoparticles.

[0021] Preferably, the sensitive layer may contain a doping element.

[0022] Preferably, the doping element is aluminum (Al).

[0023] Preferably, the glucose conversion layer is a nano-organic material encapsulating enzymes.

[0024] Preferably, the enzyme encapsulating nano-organic material is a metal organic framework (MOF) combining metal ions and organic ligands.

[0025] Preferably, the metal ion of the metal organic framework (MOF) is selected from one of alkali metals, alkaline earth metals, transition metals, group IIIA metals, group VIII metals, rare earth metals, and metal complexes.

[0026] Preferably, the enzyme is glucose oxidase.

[0027] Preferably, the control unit comprises: an MCU and a power supply, wherein the MCU controls the signal transmission of the silicon-based sensor and the calculation of the glucose content.

[0028] Preferably, the control unit also includes a wireless communication module for data communication with the outside world.

[0029] Preferably, the control unit also includes a power management module and a charging port.

[0030] Preferably, the silicon-based sensor is electrically connected to the control unit through a connector.

[0031] Preferably, a protective cover is provided outside the silicon-based sensor.

[0032] According to another aspect of the present invention, there is also provided an oral cleaning agent for use with a blood glucose meter, which is prepared from the following materials: 3-8 g of a nonionic surfactant, 2-6 g of menthol oil, 8-16 g of trimagnesium phosphate, 0.3-0.9 g of vanillin, and 0.6-2.2 g of a pH regulator.

[0033] Preferably, the oral cleaning agent further comprises 10-20 g of herbal enzyme and 0.05-0.1 g of Magnolia officinalis extract.

[0034] Preferably, the herbal enzyme consists of aloe enzyme, soapberry enzyme and papaya enzyme.

[0035] The advantages of the present invention are:

[0036] 1. The present invention uses a silicon-based sensor to detect the glucose content in the oral cavity. The silicon-based sensor is coated with a glucose conversion layer. When saliva contacts the silicon-based sensor, the glucose conversion layer decomposes the glucose in the saliva, directly generating hydrogen ions captured by the silicon-based sensor, generating an electrical signal, and then detecting the extremely small amount of glucose content in the oral saliva according to the electrical signal to correspond to the blood sugar level of the person being tested. The present invention uses saliva detection, which is easy to use and non-invasive.

[0037] 2. Based on the high-sensitivity glucose conversion layer combined with silicon-based sensor technology, the detection is efficient and the results are reliable.

[0038] 3. Fast and convenient saliva collection, suitable for daily monitoring, real-time monitoring, rapid response, and timely feedback of changes in blood sugar levels.

[0039] 4. Intelligent function: can be connected with smart devices for data recording and analysis.

[0040] 5. The present invention also provides an oral cleaning agent for use with a blood glucose meter to prevent food residues, microorganisms and bacteria in the oral cavity from affecting the detection accuracy. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Figure 1 Schematic diagram of the oral blood glucose meter of the present invention.

[0042] Figure 2 Schematic diagram of the silicon-based sensor in the oral blood glucose meter of the present invention.

[0043] Figure 3 It is a comparison chart of the detection effect of glucose with and without the MOF sensitization system of the present invention.

[0044] To facilitate understanding, identical reference numerals have been used, where possible, to designate identical elements that are common to the figures. It is contemplated that elements disclosed in one embodiment may be beneficially utilized on other embodiments without specific recitation. DETAILED DESCRIPTION

[0045] The present invention is an oral blood glucose meter. Figure 1 As shown, an oral blood glucose meter according to an embodiment of the present invention comprises a mounting portion 1. The mounting portion 1 is assembled from an upper housing 1a and a lower housing 1b, but is not limited thereto and may also be integrally formed.

[0046] The detection unit 2 is installed in the installation unit 1 and is electrically connected to the control unit 3. In this embodiment, the control unit 3 includes a substrate 30, on which various control elements (described in detail below) are arranged. A connector 36 is provided at one end of the substrate 30, and the detection unit 2 can be fixedly or detachably installed on the substrate 30 via the connector 36.

[0047] The detection part 2 is provided with a sensor 20 for receiving human saliva. The sensor 20 is coated with a glucose conversion layer 5 for converting the glucose contained in the saliva into electrical signal data, which is input to the control part 3, so that the control part 3 calculates the glucose content based on the electrical signal.

[0048] According to one embodiment of the present invention, the sensor 20 is a silicon-based sensor, such as Figure 2 The silicon-based sensor 20 includes a silicon-based substrate 21 , a SiO 2 layer (oxide layer) 22 formed on the silicon-based substrate 21 , a semiconductor device 23 formed on the SiO 2 layer, and a modification layer 24 formed on the semiconductor device 23 .

[0049] The glucose conversion layer 5 of the present invention can be coated on the modified layer 24. In this embodiment, the glucose conversion layer 5 contains glucose oxidase, especially a nano-organic material encapsulating the enzyme. The nano-organic material is a metal organic framework (MOF) (described in detail later) that combines metal ions and organic ligands.

[0050] In this embodiment, the semiconductor device 23 is an ISFET field effect transistor, wherein the gate G of the field effect transistor is formed on the SiO2 layer 22, and the drain D and the source S are respectively formed on the silicon-based substrate 21. More specifically, the drain region D and the source region S are formed at intervals along both sides of the gate region G. A sensitive layer 26 is also formed on the drain region D and the source region S. The modification layer 24 covers the gate region G, the drain region D and the source region S, and also covers the sensitive layer 26 thereon.

[0051] like Figure 2 As described above, a groove 22 a is formed on the oxide layer 22 , the gate region G is accommodated in the groove 22 a , and the drain region D and the source region S are arranged outside the groove 22 a of the oxide layer 22 to ensure that the two are isolated from each other.

[0052] The modified layer 24 includes a specially designed polymer material, such as a polyethyleneimine (PEI) derivative, which is chemically modified and has a specific functional group, and can selectively permeate hydrogen ions to ensure that the hydrogen ions generated by the glucose conversion layer 5 can pass smoothly and reach the sensitive layer 26. In other embodiments, the polymer material can also be: polyacrylic acid (PAA), polymethacrylic acid (PMAA), polystyrene sulfonic acid (PSS) or polyparaphenylene vinylene (PPV) derivatives. At the same time, the modified layer 24 may also contain small molecule additives, such as surfactants. These surfactants can improve the interface compatibility between the modified layer 24 and other layers, reduce interlayer defects and gaps, and improve the overall performance of the sensor.

[0053] The sensitive layer 26 includes a semiconductor material based on a metal oxide, such as zinc oxide (ZnO) nanoparticles, which can stably fix the relevant components to prevent them from falling off or inactivating during use. ZnO has good chemical stability and electronic conductivity, can effectively capture hydrogen ions that penetrate through the modified layer, and convert them into electrical signals. ZnO nanoparticles have a large specific surface area, can provide more active sites, and improve the sensitivity of the sensor to hydrogen ions. In addition, the sensitive layer can contain doping elements, such as aluminum (Al). The electrical properties of ZnO can be adjusted by doping Al, and its response characteristics to hydrogen ions can be further optimized. For example, an appropriate amount of Al doping can increase the carrier concentration of ZnO, accelerate the transmission speed of electrical signals, and thus improve the response speed of the sensor.

[0054] A control unit 3 is also installed in the housing 1. The control unit 3 is electrically connected to the silicon-based sensor 20 for receiving an electrical signal and measuring the glucose content through an algorithm based on the electrical signal. The control unit 3 includes a substrate 30 on which a microprocessor (MCU) 31 is installed to control the signal data transmission of the silicon-based sensor and the calculation of the glucose content. The control unit 3 also includes a power supply 32 for providing power to each component. The power supply 32 can be a battery or can obtain power by connecting to the mains. When the power supply 32 is a battery, the control unit 3 also includes a power management module 34 and a charging port 35.

[0055] The control unit 3 also includes a communication module 33, in particular a wireless communication module, for receiving external instructions and / or sending the detection results to external devices, such as mobile phones, tablets and other smart devices, for data recording and analysis.

[0056] The control unit 3 further comprises a connector 36 for connecting the silicon-based sensor 20. A switch key 37 is also provided on the substrate 30 for turning the device on and off. The display unit 4 is connected to the control unit 3 and is used to display the measured glucose value.

[0057] A protective cover 10 is disposed outside the silicon-based sensor 20 , and the protective cover 10 is used to protect the silicon-based sensor 20 .

[0058] The glucose conversion layer 5 of the present invention can be coated on the modified layer 24. In this embodiment, the glucose conversion layer 5 contains glucose oxidase, especially nano-organic materials encapsulating the enzyme.

[0059] Since the metal organic framework (MOF) is combined together by the interaction of metal ions and organic ligands, it plays an important role in the biomedical field due to its large specific surface area, excellent thermal stability, variable functional groups and uniform and adjustable pore size. In one embodiment of the present invention, the glucose conversion layer 5 adopts a MOF sensitization glucose detection system, which uses a zeolitic imidazolate framework (ZIF) as a metal organic framework, and glucose oxidase (GOx) is loaded in the ZIF to form a Gox-MOF material.

[0060] In one embodiment, the method for preparing the Gox-MOF material comprises the following steps:

[0061] S1: Add water to the reaction bottle in advance, then add metal ions, enzymes, and organic ligands in a molar ratio of 100-1500:1-10:1-150, and 0.1%-0.5% (weight ratio) of ammonia water to the reaction bottle in sequence,

[0062] S2: Mixing reaction at room temperature for more than 6 hours,

[0063] S3: After centrifugation in a centrifuge, the supernatant is removed to obtain a solid precipitate of GOx-MOF material loaded with glucose oxidase.

[0064] S4: Use water to make up to volume, and store the obtained GOx-MOF material loaded with glucose oxidase at 2-8°C for later use.

[0065] The metal ions are selected from at least one of the following metals:

[0066] 1) Alkali metals:

[0067] Lithium (Li + ): lithium chloride, lithium fluoride, lithium carbonate, lithium sulfate, lithium nitrate, lithium phosphate, lithium bromide, lithium iodide, lithium acetate and their hydrates, etc.

[0068] Sodium (Na + ): sodium chloride, sodium fluoride, sodium carbonate, sodium sulfate, sodium nitrate, sodium phosphate, sodium bromide, sodium iodide, sodium acetate and its hydrate, etc.

[0069] Potassium (K +): potassium chloride, potassium fluoride, potassium carbonate, potassium sulfate, potassium nitrate, potassium phosphate, potassium bromide, potassium iodide, potassium acetate and its hydrates, etc.

[0070] Rubidium (Rb + ): rubidium chloride, rubidium fluoride, rubidium carbonate, rubidium sulfate, rubidium nitrate, rubidium bromide, rubidium iodide and their hydrates, etc.

[0071] Cesium (Cs + ): cesium chloride, cesium fluoride, cesium carbonate, cesium sulfate, cesium nitrate, cesium bromide, cesium iodide and their hydrates, etc.

[0072] 2) Alkaline earth metals:

[0073] Calcium (Ca 2+ ): calcium chloride, calcium bromide, calcium oxide, calcium iodide, calcium sulfate, calcium acetate, calcium carbonate, calcium nitrate and its hydrate, etc.

[0074] Magnesium (Mg 2+ ): magnesium chloride, magnesium bromide, magnesium oxide, magnesium iodide, magnesium sulfate, magnesium acetate, magnesium carbonate, magnesium nitrate and their hydrates, etc.

[0075] Strontium (Sr 2+ ): strontium chloride, strontium bromide, strontium oxide, strontium iodide, strontium carbonate, strontium nitrate and their hydrates, etc.

[0076] Barium (Ba 2+ ): barium chloride, barium bromide, barium oxide, barium iodide, barium carbonate, barium nitrate and its hydrate, etc.

[0077] 3) Transition metals:

[0078] Manganese (Mn 2+ ): manganese sulfide, manganese chloride, manganese bromide, manganese fluoride, manganese iodide, manganese oxide, manganese acetate, manganese carbonate and its hydrate, etc.

[0079] Copper (Cu + / Cu 2+ ): copper sulfide, copper chloride, copper bromide, copper fluoride, copper iodide, copper oxide, copper acetate, copper carbonate and its hydrate, etc.

[0080] Zinc (Zn 2+ ): zinc sulfide, zinc chloride, zinc bromide, zinc oxide, zinc iodide, zinc sulfate, zinc acetate, zinc carbonate, zinc nitrate and its hydrate, etc.

[0081] Iron (Fe 2+ / Fe 3+ ): ferric chloride, ferric oxide, ferric sulfate, ferric sulfide, ferric citrate, ferric nitrate and their hydrates, etc.

[0082] Indium 3+): indium chloride, indium acetate, indium sulfate, indium nitrate, indium phosphide, indium bromide, indium oxide, indium iodide, indium fluoride and hydrates thereof, etc.

[0083] Thallium (Tl + ): thallium chloride, thallium acetate, thallium sulfate, thallium nitrate, thallium bromide, thallium oxide, thallium iodide and their hydrates, etc.

[0084] Palladium (Pd + ): palladium chloride, palladium acetate, palladium sulfate, palladium nitrate, palladium bromide, palladium oxide, palladium iodide and their hydrates, etc.

[0085] Silver (Ag + ): silver chloride, silver acetate, silver sulfate, silver nitrate, silver bromide, silver oxide, silver iodide, silver fluoride and its hydrate, etc.

[0086] Gold + ): Gold chloride, gold bromide, gold iodide and their hydrates, etc.

[0087] Zirconium (Zr 2+ / Zr 4+ ): zirconium oxide, zirconium chloride, zirconium fluoride, zirconium sulfate, zirconium acetate, zirconium hydrogen phosphate, zirconium dihydroxy carbonate, zirconium oxychloride and hydrates thereof, etc.

[0088] 4) Group IIIA metals:

[0089] Aluminum 3+ ): aluminum oxide, aluminum chloride, aluminum fluoride, aluminum carbonate, aluminum sulfate, aluminum nitrate, aluminum phosphate, aluminum bromide, aluminum iodide, aluminum acetate and its hydrate, etc.

[0090] Gallium (Ga 3+ ): Gallium oxide, gallium sulfate, gallium nitrate, gallium bromide, gallium iodide and their hydrates, etc.

[0091] 5) Group VIII metals: Cobalt (Co 2+ ), cobalt sulfide, cobalt oxide, cobalt carbide, cobalt bromide, zinc chloride, cobalt acetate, cobalt carbonate, cobalt nitrate and their hydrates, etc.

[0092] 6) Rare earth metals: compounds of rare earth metals such as lanthanum (La), cerium (Ce), praseodymium (Pr), neodymium (Nd), promethium (Pm), samarium (Sm), terbium (Tb), dysprosium (Dy), holmium (Ho), erbium (Er), thulium (Tm), ytterbium (Yb), and lutetium (Lu).

[0093] 7) Metal complexes: lithium cobalt oxide, lithium cobalt phosphate, potassium cobalt cyanide, strontium titanate, potassium chloroaurate, etc.

[0094] 8) Metal clusters: Zr6O4(OH)4, Zr6O4(OH)4(H2O)4, Fe3O(OH)3, etc.

[0095] Preferably, the metal ion is zinc (Zn 2+ ), for example, zinc sulfide, zinc chloride, zinc bromide, zinc oxide, zinc iodide, zinc sulfate, zinc acetate, zinc carbonate, zinc nitrate or a hydrate thereof can be used.

[0096] The organic ligand is selected from at least one of the organic ligands listed below:

[0097] 1) Nitrogen-containing organic ligands:

[0098] ① Pyrimidines: pyrimidine, 4-amino-2-hydroxypyrimidine, 2,4-dihydroxy-5-methylpyrimidine, 2,4-dihydroxypyrimidine, etc.

[0099] ②Porphyrins: porphyrin and its derivatives.

[0100] ③Phthalocyanines: phthalocyanine and its derivatives.

[0101] ④ Polyazoles: imidazoles (such as imidazole, 2-methylimidazole, 2-imidazolecarboxaldehyde, imidazole-2-carboxylic acid, benzimidazole, 2-methylbenzimidazole, 1,2,4-triazole, 3-methyl-1H-1,2,4-triazole, 1,2,4-triazole-3-carboxylic acid, etc.), polyazoles and their derivatives.

[0102] 2) Carboxylate ligands:

[0103] ① Aliphatic carboxylic acids: acetic acid, propionic acid, etc.

[0104] ② Aromatic carboxylic acids: including monocyclic and polycyclic aromatic carboxylic acids, such as benzoic acid, cinnamic acid, terephthalic acid, phthalic acid, pyromellitic acid, biphenyl-4,4'-dicarboxylic acid, biphenyl-3,3'-dicarboxylic acid, 2,6-naphthalene dicarboxylic acid, [1,1':4',1"-terphenyl]-4,4"-dicarboxylic acid, 2',5'-dimethyl-[1,1':4',1"-terphenyl]-4,4"-dicarboxylic acid, [1,1':4',1":4" ,1"'-tetraphenyl]-4,4"'-dicarboxylic acid, [1,1':4',1":4" ,1 ”'-tetraphenyl]-3,3”',5,5”'-tetracarboxylic acid, 1,3,5-tri(4-carboxyphenyl)benzene, 1,2,4,5-tetra(4-carboxyphenyl)benzene, 5'-(3,5-dicarboxyphenyl)-[1,1':3',1"-terphenyl]-3,3",5,5"-tetracarboxylic acid, 4,4-(anthracene-9,10-diyl)dibenzoic acid, 4,4',4",4"'-(pyrene-1,3,6,8-tetrayl)tetrabenzoic acid, 6,6',6",6"'-(pyrene-1,3,6,8-tetrayl)tetra(2-naphthoic acid), etc.

[0105] ③ Aromatic carboxylic acids containing additional functional groups: carboxylic acids containing nitrogen, oxygen, sulfur, bromine and other heteroatoms, such as 2-aminoterephthalic acid, 2,5-diaminobenzene-1,4-dicarboxylic acid, 2-bromoterephthalic acid, 4,4',4"-(benzene-1,3,5-triyltri(oxy))tribenzoic acid, 4,4'-(benzo[c][1,2,5]thiadiazole-4,7-diyl)dibenzoic acid, etc.; carboxylic acids containing unsaturated bonds, such as 4,4'-[1,4-phenylenebis(acetylene-2,1-diyl)]dibenzoic acid, 4,4',4",4'-(ethylene-1,1,2,2-tetrayl)tetrabenzoic acid, 4,4',4"-(benzene-1,3,5-triyltri(acetylene-2,1-diyl))tribenzoic acid, etc.

[0106] ④Mixed carboxylic acid ligands: combines multiple different types of carboxylate ligands.

[0107] 3) Other organic ligands: ligands modified with amino groups, ligands modified with photosensitizer complexes, electron-rich conjugated ligands, etc.

[0108] Preferably, the organic ligand is a polyazole: imidazole (such as imidazole, 2-methylimidazole, 2-imidazolecarboxaldehyde, imidazole-2-carboxylic acid, benzimidazole, 2-methylbenzimidazole, 1,2,4-triazole, 3-methyl-1H-1,2,4-triazole, 1,2,4-triazole-3-carboxylic acid, etc.), polyazole or its derivatives.

[0109] In this embodiment, the enzyme can be selected from natural glucose oxidase (GOx) or directed-evolved glucose oxidase (GOx).

[0110] In some more preferred embodiments, the metal is a zinc derivative or an iron derivative; the organic ligand is an imidazole: 2-methylimidazole, 2-imidazolecarboxaldehyde, 3-methyl-1H-1,2,4-triazole, 2-imidazolecarboxylic acid, 2-aminoimidazole sulfate, 3-bromo-1,2,4-triazole, etc., or an aromatic carboxylic acid: 2-aminoterephthalic acid.

[0111] In addition, Bis-PEGn-Acid chains can be added as auxiliary agents, and Bis-PEG2-Acid, Bis-PEG4-Acid, and Bis-PEG8-Acid can be selected to effectively improve the water solubility of MOF materials.

[0112] like Figure 3 As shown, according to experiments, the MOF-sensitized glucose detection system is used to effectively increase the sensitivity of glucose detection by about 5 times. After combining the MOF-sensitized glucose detection system, the oral blood glucose meter of the present invention can efficiently and reliably obtain detection results even for extremely low saliva glucose content.

[0113] In actual use, saliva contacts the silicon-based sensor 20, and the glucose oxidase in the MOF-sensitized glucose detection system catalyzes the oxidation reaction of glucose to generate hydrogen ions, which can be captured by the modified layer 24 and converted into electrical signals through the sensitive layer 26. The electrical signal is received by the semiconductor device 23 and transmitted to the control unit 3. The MCU 31 of the control unit 3 receives the electrical signal, calculates the corresponding glucose content value according to the algorithm, and displays it on the display unit 4. The calculation result can also be sent to an external device through the communication module 33 for further recording or analysis.

[0114] Although the glucose conversion layer 5 of the present embodiment adopts a glucose detection system with a MOF structure, other glucose conversion methods that can achieve the same effect may also be adopted, such as a photosensitive system or the like.

[0115] In order to avoid interference, before the test, it is preferred to use an oral cleaner to clean the oral cavity to decompose and remove food residues, microorganisms and bacteria in the oral cavity, while maintaining a neutral or appropriate pH value in the oral environment to avoid affecting the detection accuracy. The oral cleaner may contain antibacterial agents, enzyme preparations, etc. to improve the cleaning effect.

[0116] A preferred oral cleaning agent is prepared from the following materials: 3-8g of nonionic surfactant, 2-6g of menthol oil, 8-16g of trimagnesium phosphate, 0.3-0.9g of vanillin, and 0.6-2.2g of pH regulator. The above cleaning agent can also include 10-20g of herbal enzyme and a small amount (e.g., 0.05-01g) of Magnolia officinalis extract. The herbal enzyme is composed of aloe enzyme, soapberry enzyme, and papaya enzyme. However, other oral cleaning agents can also be used.

[0117] Those skilled in the art will appreciate that the foregoing examples are illustrative and not restrictive. It will be apparent to those skilled in the art upon reading the specification and studying the drawings that all permutations, enhancements, equivalents, and improvements are included within the true spirit and scope of the present invention. Therefore, the appended claims are intended to include all such modifications, permutations, and equivalents that fall within the true spirit and scope of these teachings.

[0118] Description of Reference Numerals

[0119] 1 Installation

[0120] 1a upper case

[0121] 1b Lower housing

[0122] 10 Protective cover

[0123] 2. Detection Department

[0124] 20 Silicon-based sensors

[0125] 21 Silicon-based substrate

[0126] 22 SiO2 layer

[0127] 23 Semiconductor devices

[0128] 24 Retouching Layer

[0129] 3. Control Unit

[0130] 30 substrate

[0131] 31 MCU

[0132] 32 Power Supply

[0133] 33 Communication module

[0134] 34 Power Management Module

[0135] 35 Charging port

[0136] 36 Connectors

[0137] 37 Power button

[0138] 4 Display

[0139] 5 Glucose conversion layer

[0140] D Drain

[0141] G Gate

[0142] S Source

Claims

1. An oral blood glucose meter, characterized in that: include: A mounting portion (1); A detection part (2) installed in the installation part (1), the detection part (2) comprising a sensor (20) coated with a glucose conversion layer (5), the sensor (20) being used to receive saliva to be detected; a control unit (3) electrically connected to the detection unit (2), the control unit (3) being used to measure the glucose content value of the saliva received by the silicon-based sensor (20); A display unit (4) is used to display the glucose content value measured by the control unit (3), The glucose conversion layer (5) is used to convert the glucose in the saliva to be detected into hydrogen ions, so that the hydrogen ions are captured by the sensor (20) and converted into electrical signals, and the electrical signals are input into the control unit (3), and the control unit (3) calculates the glucose content value based on the electrical signals.

2. The oral blood glucose meter according to claim 1, characterized in that: The sensor (20) is a silicon-based sensor.

3. The oral blood glucose meter according to claim 2, characterized in that: The silicon-based sensor (20) comprises a silicon-based substrate (21), an oxide layer (22) formed on the silicon-based substrate (21), a semiconductor device (23) formed on the oxide layer, and a modification layer (24) formed on the semiconductor device (23), wherein the glucose conversion layer (5) is coated on the modification layer (24).

4. The oral blood glucose meter according to claim 3, characterized in that: The semiconductor device is an ISFET field effect transistor, and the ISFET transistor comprises a gate region (G), a drain region (D) and a source region (S), wherein the gate region (G) is formed on the oxide layer (22), the drain region (D) and the source region (S) are formed at intervals along both sides of the gate region (G), and a sensitive layer (26) is formed on the drain region (D) and the source region (S).

5. The oral blood glucose meter according to claim 4, characterized in that: The drain region (D) and the source region (S) are formed on a silicon-based substrate (21).

6. The oral blood glucose meter according to any one of claims 3 to 5, characterized in that: The oxide layer (22) is a SiO2 layer.

7. The oral blood glucose meter according to any one of claims 3 to 5, characterized in that: The oxide layer (22) is formed with a groove (22a), the gate region (G) is arranged in the groove (12a), and the drain region (D) and the source region (S) are arranged outside the oxide layer (22).

8. The oral blood glucose meter according to claim 1, characterized in that: The modified layer (24) comprises a chemically modified polymer material having a selective permeability to hydrogen ions.

9. The oral blood glucose meter according to claim 8, characterized in that: The polymer material is a polyethyleneimine (PEI) derivative, polyacrylic acid (PAA), polymethacrylic acid (PMAA), polystyrene sulfonic acid (PSS) or polyparaphenylene vinylene (PPV) derivative.

10. The oral blood glucose meter according to claim 1, characterized in that: The sensitive layer (16) comprises a metal oxide based semiconductor material.

11. The oral blood glucose meter according to claim 10, characterized in that: The metal oxide is zinc oxide (ZnO) nanoparticles.

12. The oral blood glucose meter according to claim 10 or 11, characterized in that: The sensitive layer may contain doping elements.

13. The oral blood glucose meter according to claim 12, characterized in that: The doping element is aluminum (Al).

14. The oral blood glucose meter according to claim 1, characterized in that: The glucose conversion layer is a nano organic material encapsulating enzymes.

15. The oral blood glucose meter according to claim 14, characterized in that: The enzyme encapsulating nano organic material is a metal organic framework (MOF) combining metal ions and organic ligands.

16. The oral blood glucose meter according to claim 15, characterized in that: The metal ions of the metal organic framework (MOF) are selected from alkali metals, alkaline earth metals, transition metals, group IIIA metals, group VIII metals, rare earth metals, and metal complexes.

17. The oral blood glucose meter according to claim 5, characterized in that: The organic ligand of the metal organic framework (MOF) is selected from one of nitrogen-containing organic ligands, carboxylate ligands, amino group-modified ligands, photosensitizer-composite-modified ligands, and electron-rich conjugated ligands.

18. The oral blood glucose meter according to claim 4, characterized in that: The enzyme is glucose oxidase.

19. The oral blood glucose meter according to claim 1, characterized in that: The control unit (3) comprises: an MCU (31) and a power supply (32), wherein the MCU controls the signal transmission of the silicon-based sensor and the calculation of the glucose content.

20. The oral blood glucose meter according to claim 19, characterized in that: The control unit (3) also includes a wireless communication module (33) for data communication with the outside world.

21. The oral blood glucose meter according to claim 19, characterized in that: The control unit (3) also includes a power management module (34) and a charging port (35).

22. The oral blood glucose meter according to claim 1, characterized in that: The silicon-based sensor (20) is electrically connected to the control unit (3) via a connector (36).

23. The oral blood glucose meter according to claim 1, characterized in that: A protective cover (10) is arranged outside the silicon-based sensor (20).

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