TW200422608A - Integrated electrochemical biochemical sensor device and its sensing method - Google Patents

Abstract

The present invention provides an integrated electrochemical biochemical sensor device and its sensing method, which combines blood gathering design, continuous multiple times of inspection design, multi-channel sensing design and adjustable working voltage design, and is capable of detecting the inspected result of multiple physiology parameters in the same inspection. With such a design, it is able to provide convenience to the users and increase the utilization. This integrated electrochemical biochemical sensor device includes at least one sample gathering device utilizing a sample carrying space in the sample gathering device, wherein the internal of the sample carrying space is in a vacuum or negative pressure state, to make the to-be-tested organism body fluid sample with a relative high pressure rapidly enter the sample carrying space by external force together with pressure difference; plural electrode sets, each having a working electrode, a reference electrode and an auxiliary electrode, wherein when the to-be-tested organism body fluid sample enters the sample carrying space, the working electrode and chemical material thereon perform chemical and physical reaction with the to-be-tested organism; a multi-channel electrochemical sensing device capable of providing plural working voltages to the plural working electrodes; an operating logic and data capturing device for performing data capture and operation on the chemical and physical reaction result; and a signal display device for precisely displaying the physiology parameter value of the to-be-tested organism body fluid sample, and the concentration corresponding to the physiology parameter.

Description

200422608

V. Description of the invention (l) [Technical field to which the invention belongs] The present invention is an integrated electrochemical biochemical sensing method% L _lyt / see 丨 "Methods", especially using an integrated module for multiple times Biochemical sensing of organisms. [Previous technology] Xizhong sample mouth Bio-sensing systems and bio-electronic products use bio-molecular characteristic forces as a test tool. Bio-sensors use bio-molecules (such as: white matter, genes, enzymes, antibodies, (Nucleic acid, etc.) as identification: A piece of electronic product is placed on a traditional inorganic semiconductor material (such as a silicon wafer) with a specific biological material (such as a protein molecule), and is released after a specific biochemical reaction of other substances. Messages can be quantified in real time, combined with signal transmission, signal processing and calculation in one body, and are used in medical inspection, food testing, agricultural monitoring, environmental protection, health industry, pharmaceuticals and other applications. "Ϊ́ϊϊ: !! The development trend of the society, As a result, the Jujing care-type medical alpha material industry has become the mainstream of global medical device development, and the demand for home-type belt-type / personalized physiological and biochemical sensing systems has also increased. For example: glucose biochemical sensor for measuring physiological parameters of diabetes and biochemical sensor for glycosylation, uric acid biochemistry for measuring physiological parameters of gout disease, biochemical tests, biochemical tests for vascular disease related parameters, triglyceride and cholesterol ^ S biochemistry The development of sensors, blood oxygen concentration sensors for cardiopulmonary function, and electrocardiographs. Among them, diabetes-related tests are most important. Diabetes is a chronic disease, the number of patients is constantly increasing, and there is no cure for this disease,

Page 5 200422608 V. Description of the invention (2) 'A lot of people spend a lot of time and money on the diagnosis and treatment of this type of diabetes. More than US $ 100 million of the US health insurance system ’s annual expenditure is related to the diagnosis and treatment of diabetes, and the cost of unemployment associated with diabetes is even greater. The World Health Organization (The W〇rld HeaUh 〇rganizati〇n) and the U.S. Center for Disease Control (U.S. Center for Disease

Contro 1) has already signaled the rapid growth of diabetes worldwide. °

Sexually transmitted diseases must be measured regularly for a long period of time by measuring various physiological parameters in the blood, in order to understand the physical condition. This is currently the most accurate method for testing. This method of testing various physiological parameters on the market currently requires a needle to obtain a drop of blood for inspection. Although there are also non-intrusive watches, the development of intellectual intelligence = system, and it has passed the FDA certification. The non-feature watch-type sensing system measures the hyperparameters secreted in the skin's sweat, which is affected by the environmental weather and the patient's sweating, etc. The measurement # 生 ^ 理 理 值 is not accurate enough, so it is still needed It is often compared with each other after measurement using traditional sensing systems.

: I In addition, many complications of patients with chronic diseases cannot be judged simply by examining the concentration of a single physiological parameter in the blood. The multi-parameter physiological parameter detection system is very important for patients with chronic diseases. Example: Cardiovascular :: Physiological examination of risk factors], and the detection of uric acid in the blood is also a physiological parameter of 1 or missing; because social progress is related to dietary habits Disease also plagues many patients. But as of I ^ ^ only few home testing or personal testing equipment with many physiological parameters has been developed or introduced. Most home / portable / personalized physiological parameters

200422608 V. Description of the invention (3) --- The detector must be used in conjunction with the blood collection equipment, and different physiological parameters must be tested using different test strips or even the detection module, in order to know the different physiological parameters It is not convenient to use. The present invention provides a fully-equipped multi-channel electrochemical biochemical sensing system, which combines blood collection design, continuous multiple inspection design, multi-channel sensing design, and adjustable working voltage design, etc., and can learn multiple physiological parameters in the same test. The test results, through this design, provide users with convenience and value in use. [Summary of the invention] The purpose is to provide more convenience for detection when the technology is provided, so that the technology will use blood collection needles to obtain enough information, the device, carries a parameter flow, and the convenience is another integration into a continuous item of simple blood collection for physiological use In contrast to the user who pierced the skin with enough blood, if the replacement is insufficient, it is troublesome. The mechanism is different from that of the user, so the liquid sample is tested and the blood collection device is prepared. And from the parameters to the replacement of inspection equipment and test procedures, the inspection is integrated, and the inspection can be carried at the same time. The previous procedure must be clean. The above procedures can be used and the sensor test can only test the above test modules. The use and post-processing also use the biochemical test parameters for multiple tests, so that at the same time, the test program is divided into different skins. In order to obtain a blood sample, it must be inconvenient to test different raw test pieces at any time. At the same time, the parameters of this device are used only once during the blood collection and detection process, and the user is ready to analyze at the same time. The preparation and test strips must be re-tested in a single inspection. The discarding of the tablets is in view of this. The present invention provides an integrated electrochemical biochemical sensing system.

200422608

'It is a combination of blood collection design, test strip design, and sensing instrument design. It completes the work of detecting multiple physiological parameters while collecting blood, providing users with more convenient and valuable services, and the present invention provides The window of multiple inspections eliminates the need to carry multiple devices at the same time, such as lancets and test strips, to increase the convenience of use. The value of biochemical sensors and the competitiveness of the biotechnology industry will increase.

The integrated electrochemical biochemical sensing system of the present invention combines a blood collection design, a test strip, a multi-parameter inspection and detection device, and does not require additional blood collection equipment and test strips, and can detect multiple physiological parameters at the same time. Another feature of the present invention is that it has the advantages of multiple inspections without the need to replace the test strips, because each detection area can work independently without affecting each other, and it is not necessary to carry other related equipment when using, increasing the convenience of use. And increase the value of use. Those familiar with this physiological and biochemical sensor industry know that the development of a variety of biochemical sensors with the same purpose is a fairly mature technology. Most of the products currently on the market are developed for blood glucose testing, including ··

All-In ONE BD developed by Becton Dickinson

LatitudeTM Diabetes Management System and New BD LogicTM Blood Glucose Monitor, Precision QID blood glucose meter developed by MediSense, Elite blood glucose meter series developed by Bayer, a series of blood glucose analysis products developed by Hypoguard, and designed by Lifescan Ultra meter and the Accu-Chek Compact meter developed by Roche, etc., but there are also uric acid molecule concentrations in blood and cardiovascular disease related factors, such as:

200422608 V. Description of the invention (5)

CardioCheck P · ATM series developed by Polymer Technology System Inc. However, most of these detection devices need to be equipped with blood collection equipment and dedicated test strips, and even when used, different test or calculation modules must be replaced in order to perform a single physiological parameter test.

All-ln-〇ne BD LatitudeTM Diabetes Management System developed by Becton Dickinson, this design is a combination of blood collection device, test strip and sensing system, but it must still be used separately, but this design makes the disease Patients are more convenient to carry. A small part is combined with a blood collection device, a test strip and a detection system, such as the Sof-TactTM blood glucose meter developed by G 1 ucerna. This blood glucose meter can put the blood collection needle and test strip in the detection device in advance, and can Count the time of day-to-day inspection, and in addition, 'This system uses a small vacuum pump to collect blood samples'. When the machine is close to the skin, the vacuum pump sucks up the skin. At this time, the blood collection needle pierces a small hole in the skin. Utilize the effect of vacuum pump to make the blood flow out quickly, and use the test market to collect the outflowed blood to directly test the physiological parameters. In addition, there is also a design that combines the PDA system as a patient medication and pathological monitoring to enable patients to record in detail Medication time and changes in personal physiological parameters, such as OneTouchRUltraSmartTM Blood Glucose Monitoring developed by Li fescan

System, this system can be used to input personal health status, onset experience, medication experience, current medication diet status, etc., and combine blood glucose test results to become a personalized diabetes management system; TheraSense company developed the Freestyle Tracker system Combining digitized functions of current test results, past test records, same-day test records, etc. with pda

Page 9 200422608

V. Description of the invention (6) A new generation of glucose detection equipment has been developed, and this system has been approved by the US Food and Drug Administration. In order to make those familiar with the art understand the purpose, characteristics and effects of this creation, hereby use the following specific embodiments and the accompanying drawings to explain this creation in detail. [The implementation of the present invention includes product processing such as blood collection parts, blood, and sensing. The electrochemical detection of the present invention does not require the vacuum or time of the hair detection, and the space is quickly removed. Please be electrochemical for the test solution Students and students with innovative invention test strips and users who are different or different are integrated into a simple, pressure-differentiated skin where the detection part will wear or negative pressure will stop, such as: In this case, the above-mentioned actions will be used to replace the above-mentioned sensing with the negative pressure-like area that is clearly specified. The first color is the detection of the internal and external pressure. The first color is that the signal-sensing blood collection device is missing. The independent system has the superior blood mode, when the blood device in the micro area is balanced in force. The diagram is an integrated output with technical settings, sense, and multi-object integrated operation points. It is based on the user's blood collection device, which is detected by the vacuum and continued detection. At present, the sensing system must be tested in a convenient way, so that it can be pressed through the detection state, ‘full of this system, the system does not need to replace the system with the traditional separation of the market to collect blood and take work. Therefore, this integrated type and continuously detectable skin in the detection area. Therefore, the blood detection area accurately reaches the three-dimensional image display of a preferred embodiment of the present invention.

Page 10 200422608 V. Description of the invention (7) Each part of the front operation panel of the sensing device 1 which is not one of the present invention includes: a group sample collection device 11 ′ a signal display device 19 and five buttons 丨 2. Each group of sample collection devices 11 has an electrode group 13 that is matched. When the sample collection device 11 is driven by pressing the f12 button, the collection of the biological fluid sample to be measured is started, and the electrode group 13 is used for inter-sample Chemical and physical reactions, the results are displayed in the news \ display device 1 through the role of a multi-channel electrochemical sensing device (not shown) and two operations = negative material capture device (not shown) . The plurality of buttons 丨 2 are provided with functions such as displaying the time, changing the previous measurement i, etc. after pressing for a few seconds without holding or pressing different buttons. At the same time, the physiological parameters detected by the plurality of detection areas can be adjusted according to different product designs, and it is not limited to detecting a single physiological parameter. Please refer to FIG. 2 and FIG. 3, which are preferred embodiments of the present invention; and FIG. Among them, the present invention "integration = chemical and biochemical sensing device" includes: a plurality of, using one of the sample collection device in the sample bearing space = installed and placed two '(pressure Λ difference way to form a vacuum inside the sample bearing space Or, C-shaped sadness (belonging to the well-known technology, not to discuss here), to facilitate the biological fluid sample 17 to be tested (Figure 2 shows that it comes from a finger 53) 4 ^ quickly and quickly enter the sample The inside of the load-bearing space is 113, and the sample collection needle ϊΐΠίί needle 115, and this-the needle 115 can break through the Π-is created by a small hole 119 'to facilitate the entry of the biological fluid sample 17 to be tested

200422608 V. Description of the invention (8) 132. Hard-several test groups 13, each electrode group 13 includes-working electrode liquid sample 17 into the drawing. 13 ^ An auxiliary electrode 131, when the organism to be tested and its physical characteristics: the space inside the space 11 3, the working electrode 1 32 responds, and the chemical reaction of the biological fluid sample to be tested will be physical and physical The first chemical reaction of the work is to use the working electrode 132-, which uses the oxygen C molecule to react with the biological fluid sample 17 to be tested as the electron transfer medium f for the electrodeposition reaction, and the first type of work is Γ electric ii; perenzyme The molecule is repaired together with a suitable cross-linking reagent. ^ In the eighth, the 5 enzymes are redox enzymes, including: chemical enzymes, glucose dehydrogenases, cholesterol oxidizing enzymes, chemical compounds f, and the Cross-linking reagents can be polyaldehyde-based polymer compounds: compounds, compounds containing bisaldehyde groups, high polyamine compounds, natural products of polyaldehyde groups, and compounds containing bisamine groups 2nd, molecular compounds, 2m-based polymer natural products, and chemical compounds with similar molecular morphology of the direne group, and the second chemical reaction between the chemical substance and the liquid sample 17 of the biological body to be tested uses this One of the working electrodes 132 contains a working surface The enzyme molecule reacts with the electron transfer medium and the biological fluid sample to be measured, and the second working electrode refers to the electrode modified by the enzyme molecule with a suitable cross-linking reagent and a suitable electron transfer medium. The electron transfer medium It includes an electron acceptor, an electron donor, and a catalytic reagent. On the other hand, the physical reaction is made of a working electrode 132 which is made of a highly conductive ink containing carbon ink or other metal ink, and then passed through appropriate and sufficient operations. Voltage to facilitate electron transfer in chemical reactions. The reference electrode 1 3 3 can be used as a relative indicator of the working voltage applied by the working electrode.

Page 12 200422608 V. Description of the invention (9) Including silver / silver chloride reference electrode or saturated calomel electrode or other materials that can be used as test electrode, the auxiliary electrode 131 can be made of carbon oil $ 墨 # or Other metallic inks are made of conductive inks or similar metals. A multi-channel electrochemical sensing device 14 is capable of providing a plurality of working voltages and passing a plurality of wires 141 to a plurality of jobs in the electrode group 13. Electrode 132, the multi-channel electrochemical sensing device 14 can be appropriately adjusted according to different species or electron transfer media; an arithmetic logic and data filling device 16 is used to pass chemical and physical reactions through a wire 142 The results are used for data manipulation and calculation; a signal display device 19 connects the different logic and data acquisition device through a wire 1 6 1 6 data is retrieved and calculated to display the biological fluid sample to be measured 丨The physiological parameter value of 7 or the concentration corresponding to the physiological parameter. However, in this embodiment, there are two kinds of working electrodes in the plurality of electrode groups, that is, the first type can achieve multiple life by modifying different enzyme molecules and cross-linking reagents, the test of parameters, and the second type It is possible to achieve the test of multiple physiological parameters by modifying different enzyme molecules, conjugated reagents, and electron transfer media. —Taking glucose sensing as an example ’200422608 V. Description of the invention (10)

Glucose Glucose Electron γ Oxidase ^ Aceptor Gluconic ^ V. Glucose y \ Electron Acid Electron • 〆 Oxidase Aceptor

Generally speaking, nature uses oxygen molecules as the electron acceptors required for enzyme biochemical reactions. The schematic diagram of electron transfer is as follows:

Glucose, / Glucose v Oxidase 'yH2〇2 f Gluconic〆, Glucose / X 〇2 Acid Electron Oxidase

Transfer Therefore, the glucose concentration can be quantified by measuring the consumption of oxygen gas molecules or the production of hydrogen dioxide molecules. The electron acceptor can also be other chemical substances, such as: Ferrocene, K3Fe (CN) 6, TTF-FCNQ, etc. Taking K3Fe (CN) 6 as an example, the schematic diagram of its electron transfer is as follows:

Page 14 200422608 V. Description of the invention (11)

Glucose

Gluconic Acid X Glucose Oxidase

Glucose

Electron Oxidase Transfer v yFe (CN) 64_ / VFe (CN) ^

By measuring the electron transfer of Fe (CN) 63- / Fe (CN) 64- to achieve the purpose of measuring the glucose concentration. In addition, it can also be used to detect the amount of generated hydrogen dioxide for quantitative purposes. For example, Prussian blue crystals are used as a catalyst for hydrogen dioxide. The schematic diagram of electron transfer is as follows: H2〇

Glucose \ / Glucose v Oxidase \ / H2〇2 Gluconic〆, Glucose / V 〇2 Δ. 1 Electron ACKl Transfer Oxidase

This mechanism quantifies the glucose concentration by the electron transfer obtained by the reduction reaction of hydrogen dioxide. Other electrode groups perform different detection tasks. The specificity of detection between different electrode groups is identified by enzymes or other biochemical molecules fixed on the working electrode.

Page 15 200422608 V. Description of the invention (12) Examination of the selectivity and specificity of the species and the specificity of the specific parameters. In order to achieve a variety of students, in addition, on the evening of the present invention, between the electrode groups, the electrochemical detection system can be adjusted for different electrical voltages with different voltages, and these operating parameters are adjusted, and 2 In order to distinguish the different concentrations in different physiological tests, and visits = different physiological detection parameters are not the same in the body, so the basic characteristics of the knife in the system and logical operation methods can be used between the same electrode group Different designs are then displayed through the electronic circuit to display the signal after analyzing the physiological test on the display 21 'Auxiliary' One electric, there are four working electrodes 132, four and reference electrodes, so, ^; four sets of working electrodes, auxiliary electrodes. _ So ―collection, analysis of four physiological parameters can be performed. The two [王 UiU: 2]; ”set device π, so you can apply different working pressure to different groups at the same time for different voltage sensing devices 'Or you can not apply different working electrical voltages at the same time according to f 2 5 5, which is applied by the working electrode. And the electron transmission medium is different, it can be adjusted by different meter: electric == physiological parameters For details, please refer to Chapter 4— 丄 Picture 2: Early—Physiological Parameters. 1 Picture is another example of the sample collection device of the present invention 200422608 V. Description of the invention (13) Application: Schematic. The sample collection device The sample Λ-j large output 215 of 21 can generate a tiny hole (such as a small blood through this tiny protruding small hole to expose σ, wife σ; at a sample collection point) The temple has 4 夂 guandi / 1 π mouth opening penetrated into the mouth opening bearing space 21 3. The second and fourth views are shown in Fig. 4 and Fig. 2, which are schematic diagrams of the sample taking examples of the present invention. The sample collection device 41bis Special design in the inside of the pin—protruding H The outer 415 of 4 ″ 3 can penetrate the casing 411 U. This dog produces a tiny hole in a certain fantasy (two f :: wooden points (such as the tiny hole on the finger and the relative negative or vacuum inside the casing 411 = Hours: =? Penetrate into the sample bearing space 413. The shape of the sample mouth is shown in Figure 5, which is a schematic diagram of the sample collection of the present invention. The sample collection device 31 of the sample collection device 31-the second one: The design produces a needle 31 two two 313: Bu = small hole 'and a small ball as an air-tight seal. There is-= vacuum or negative pressure in the bearing space #. The hole penetrates the sample into the sample carrier; the tiny protrusions can be transmitted through the space 313. Please refer to FIG. 6, which is an integrated electrochemical biochemical sensing method of the present invention: Department spoon = step. This Invention (1) A biological fluid sample is measured using one of a sample collection device, that is, the sample holder; a load space is used to collect a state of pressure, and an external force is used to match the pressure difference = ^ internal pressure is a vacuum or a relatively negative biological fluid to be measured Samples can be quickly entered: to facilitate the entry of relatively high pressure into the space where the sample port is planted Among them, page 17 200422608 V. Description of the invention (14) The following three examples can be used to obtain samples: two needles and two needles: this needle can break through the outer periphery and can generate a sample at a sample collection point. fThe war room uses the sample bearing space to pass through the = hole; or it can be, this-the protrusion can be slightly protruding from a sample; the product bearing space shell is specially set; = = large holes, A microsphere is used as an airtight seal in the vacuum or negative pressure state of the μ-holding sample bearing space; in dimension (2), at least one of the plurality of electrode groups is used to obliquely go to the heart body fluid sample for chemical and physical reactions. After each-,] ,, 彳 biological working electrode, -reference electrode and -auxiliary electro-hydraulic sample enter the sample carrying space, the chemistry-chemical substance: chemical reaction with the biological fluid sample to be tested === chemical reaction system uses The working electrode of the worker: reacts with the biological fluid sample to be tested. 1 oxygen; jj :: === 2 and the working electrode refers to the electrode modified by the fermentation of == Kota and the reagent. The pot is Redox enzyme * ' Including: glucose oxidase ;, glucose; sugar = j polyoxidase or similar chemical substances, the cross-linking test dicomplex, multi-base polymer natural products, double-basing: Huaren ί shang Molecular compounds, natural polyamine-based polymers, bisamines: chemical compounds of carboxyl groups, natural polymers of polyfluorene-based polymers, engineering:;, or similar chemical substances; the second chemical reaction system One of the electrodes contains an enzyme molecule and a suitable

Page 18 V. Description of the invention (15) Cross-linking reagents and appropriate electronic reactions, and the working electrode refers to the agent and the appropriate electron transfer electrode and the biological fluid sample to be tested are properly and adequately operated by carbon-containing ink or other metals The electric electrode group may further include a working electrode applied to the electrode by multiple working voltages, and a saturated calomel electric electrode whose material is made of or similar metal (3), and the result is used for extraction and calculation. The operating voltage pole or the carbon-containing oil is used to calculate the logic of the transmission medium and the high-conductivity room of the physical ink jointly performed by the enzyme medium to facilitate the electrochemical sensor; the relative index of this parameter, he Can be used as reference ink or other gold molecules to be tested and modified reaction system for electrical oily reaction test device. Test electrode includes silver test electrode. It is an appropriate electrode for ink liquid. When the cross-linking generated from the high-conductivity sample of the / chlorinated material, the working electricity is used as the electrode system, and then passed through; the supply should be at least the working silver reference electricity; the auxiliary electrical ink series and the data are extracted from the chemical and physical materials. Take the device to capture the results of the physical reaction and calculate the data. (4) Use a signal display device to clearly display the physiological parameter values and the corresponding concentrations of the physiological parameters of the biological sample to be measured. Although, the present invention is disclosed above with a plurality of preferred embodiments, it is not intended to limit the present invention. #Every equivalent change and modification made in accordance with the scope of the patent claimed in the present invention shall still belong to the patent of the present invention. The scope of coverage shall be determined in accordance with the scope of application for patent coverage locked after the warranty period of this issue. 200422608 Brief description of the drawings [Simplified description of the drawings] Figure 1 is a perspective view of a preferred embodiment of the present invention; Figure 2 is a top side view of the preferred embodiment of the present invention; Figure 3 is a detailed diagram of an electrode group Figure 4-1 is a schematic diagram of another embodiment of the sample collection device of the present invention; Figure 4-2 is a schematic diagram of another embodiment of the sample collection device of the present invention; Figure 5 is another implementation of the sample collection device of the present invention Example diagram; Figure 6 is the steps of the sensing method of the present invention. [Illustration of drawing number] 1 Sensing device 11 Sample collection device 111 Housing 113 Sample carrying space 115 Needle 117 Sample collection point 119 is a small hole 12 Button 13 Electrode group 131 Auxiliary electrode 132 Working electrode 133 Reference electrode 14 Multi-channel electrification Learning sensing device 141 lead 142 lead

Page 20 200422608

Brief description of drawings on page 21 15 Fingers 16 Operation logic and data acquisition device 161 Lead 17 Biological fluid sample to be measured 19 Signal display device 21 Sample collection device 211 Housing 213 Sample carrying space 215 Projection 31 Sample collection device 311 Housing 313 Sample Carrying space 315 Projection 317 Small rubber ball 41. Sample collection device 411 Housing 413 Sample loading space 415 Projection

Claims (1)

200422608 VI. Scope of patent application1. An integrated electrochemical biochemical sensing device, which is at least one sample collection device, uses such a sample bearing space and uses external force to press the inside of the sample bearing space to form a vacuum or negative pressure. A biological fluid sample to be tested can quickly enter at least one auxiliary room. The internal liquid is physically connected. 2 · If you apply for a sensing device, explicitly count the value 3 · If you apply for a sensing device, and the brigade is available at 4 · If you apply for a sensing device The electrode group produced at the point of production includes an electrode. After that, the working sample is subjected to calculation logic and corresponding results. The patent range is set, which shows the following and physiological parameters. The range of this needle-shaped sample is patented. One of the micro-bursts and one of the micro-beams to be tested is used as the electrode and its chemical and physical data retrieval equipment is described in item 1 of the item "The device is more of any one: the item to be counted corresponds to the item 1" The sample collection can break through the set point to produce the sample collection, the hole described in item 1. The working electrode is a chemical reaction on a body fluid sample; it is a system that will capture and operate a whole body including a signal to measure the concentration of the organism. In a whole set of devices, a sample carrying a micro-hole outside of the full load space may include: The difference in force in the product collection device makes the state 'to facilitate the inside of a relatively high quality load space, a reference electrode and access to the sample Carrying empty matter will be chemically calculated with the test students. ^ Synthetic type electrochemical biochemical number shows clothes, and the physiological dissonance type electrochemical biochemistry of liquid sample has a shell with a needle-like space, and the hole 0 type electrochemical biochemical shell passes special M to- 4 episodes: Page 22 200422608 5 · If the sensing device is applied for a patent, it is planned to produce a micro-sealing function. In one of the items described in item 1, the sample bearing space protrudes from the small hole, and a micro is used to maintain the sample bearing space. A special small ball is set on the chemical shell as the working surface of the closed-type electro-organism in vacuum or negative pressure. It should be used as an electrode and modified electro-reductive enzyme. The oxygen molecules contained refer to the electrodes passing through. Chemical biochemicals, including alcohol oxidizing enzymes6. An integrated measuring device as described in item 1 of the scope of patent application, wherein the chemical reaction between the chemical substance and the test substance uses an enzyme molecule of the working electrode and the test substance A biological fluid sample produces an electron transfer medium that acts as a biochemical reaction, and the enzyme molecule and an appropriate cross-linking reagent are combined. 7 A whole sensing device as described in item 6 of the patent application scope, wherein the enzyme molecule For oxidation: glucose oxidase, glucose dehydrogenase, and similar chemicals. 8 · An integrated electrochemical biochemical sensing device as described in item 6 of the scope of the patent application, wherein the cross-linking reagent may be any one of the following: polyjune polymer compounds, polyaldehyde-based polymer natural products, Dialdehyde-based compound, polyamine-based polymer compound, polyamine-based polymer natural product, bisamine-based compound, polycarboxyl polymer compound, poly-based polymer natural product, dicarboxyl compound, or similar chemical substances. 9 · An integrated electrochemical biochemical sensing device as described in item 1 of the scope of the patent application, wherein the chemical reaction between the chemical substance and the biological fluid sample to be measured is performed by using the 200422608 Enzyme molecules and electricity, and working electrical reagents and appropriate sensing devices such as patent applications, which include glucose oxidants, and similar sensing devices such as patent applications, which are based on high molecular compounds, polyamines and high amines. For compounds, natural substances, and dicarboxyl groups, such as patent application sensing devices, the body, electron donor transfer medium, and biological fluid sample to be tested generate antipolar means that the enzyme molecule and an appropriate crosslinked electron transfer medium Jointly modified electrodes. In the integrated electrochemical biochemistry described in item 9, the enzyme molecule is a redox enzyme, including enzymes, glucose dehydrogenase, and cholesterol-oxidizing chemicals. 12. 13. 14. In an integrated electrochemical biochemistry as described in item 9 above, the cross-linking reagent may be any of the following: polyaldehyde, multi-path polymer natural substance, bis-aldehyde compound molecular compound, polyamine-based polymer natural Substances, bis-polycarboxyl polymer compounds, poly-carboxyl polymer compounds, or similar chemical substances. In the integrated electrochemical biochemistry described in item 9, the electron transfer medium includes: an electron acceptor and a catalytic reagent. As described in item 1 of the scope of the patent application, an integrated variable electrochemical biochemical sensing polymer is used, in which the physical reaction between the working electrode and the biological fluid sample to be measured is made of carbon-containing ink or other conductivity using the working electrode system. Metal inks are made of highly conductive inks, and then passed with an appropriate and sufficient operating voltage to facilitate the electron transfer of chemical reactions. The integrated crack electrochemical biochemical sensing device described in item 1 of the scope of patent application, wherein the electrode group may further include a multi-channel electrochemical sensing device, which can provide at least one working voltage to the working electrode. Page 24 200422608 6. Scope of patent application 1 5 · If apply for sensing device to apply industrial chemical silver ginseng material 1 6. If apply for sensing device other guide patent range No. 1, among which, the relative voltage test electrode, saturation patent range , Its electrical gold, carbon, gold, platinum 1 7 · — an integrated type of electricity at least one sample sample is to be pressurized to be a sample carrying no-load space to measure the biological circle No. 1, which belongs to the ink, similar student collection room The internal fluid samples are described as follows: an integrated electrochemical biochemical electrode system can be used as the working electrode, including any of the following: silver / chlorine electrode, others can be used as reference electrodes One of the above-mentioned | electrochemical biochemical f electrodes is made of carbon-containing ink or gate ink, including: similar metals. The chemical sensing device includes: The spear J uses the two forces in the sample acquisition device to cooperate with the pressure difference to make it into a vacuum or negative pressure state, so that relatively high-quality products can be quickly caught into the sample carrying space. Each electrode group includes a working electrode, a reference electrode, and an auxiliary electrode. When the biological fluid sample to be tested enters the sample buckle carrying space, the working electrode and the chemical substances on the working electrode and the biological substance to be measured Bodily fluid samples undergo chemical and physical reactions; a multi-channel electrochemical sensing device that provides a plurality of working voltages to the plurality of working electrodes; an arithmetic logic and data acquisition device, which has been subjected to chemical and physical reactions The result is data acquisition and calculation. 6. Scope of patent application _ 1 8. If the scope of patent application is for chemical sensing devices, two of them are integrated electrochemical cells to clearly display any of the following: Two J include-signal display device, parameter value, A 4 shot , 'The snoring sound corresponding to the physiological resistance physiological parameter of the biological fluid sample. 19 · According to the scope of the patent application, an integrated electrochemical cell uu i ′, which is described by the chemical sensing through w #,, Jin, wherein the sample is: And this-the needle can break through the sample, and can be produced at a sample collection point: a wide range of peripheral equipment 20. = Please refer to the "scope of patents"-an integrated electrochemical device; 2 micro ^! 出: Passed on the outer shell of the sample-bearing space: This ... This—the protrusion can be used in the sample: 1: ΐ = an integrated electrochemical generator described in item 17 above: Set 'wherein' the outer shell of the sample-bearing space It has a special small hole on the top, and it uses-tiny energy. It is used to maintain the vacuum or negative pressure in the sample bearing space. 22 ·! In the device, the chemical reaction between the chemical substance and the biological fluid sample to be measured is to use a knife containing an enzyme on the working surface of the working electrode to react with the biological fluid sample to be tested. The oxygen content is used as the biochemical reaction for electron transfer. Medium, and the working electrode refers to the electrode modified by the peroxidase molecule and an appropriate cross-linking reagent. Page 26 6. Scope of patent application 23. If the scope of the patent application is No. 22, households, +, and chemistry sensors, in which the enzyme-integrated electrochemical auxin and the similar chemical = degassing Oxidation of enzymes and cholesterol? 4 As mentioned above, the scope of the application for patent No. 22 + 2 chemical sensing devices ..., the cross :: ;;;; integrated electrochemical bio-based polymer compounds, and more A ^, ::, 2. Any one of the following. Polymers, polyamine-based polymers 4 :: = compounds, bis-acrylated bisamine-based compounds, polycarboxyl polymers, natural products, bismuth compounds? ;: =, Multiple-based polymer y or similar chemical substances. 25. The electrochemical sensing device as described in item i 7 of the scope of the patent application, wherein the chemical compound is completely dried, ^ c „; " The chemical reaction is to use the electrons contained in the working surface of one of the working electrodes to react with the electrons and the biological fluid sample to be tested, and the working electrode refers to the enzyme molecule and -appropriate A M and appropriate The electrode modified by the electron transfer medium 26. One of the integrated electrochemical cells described in item umr5: glucose oxidase, grape vinegar = reductive enzyme, lysozyme, and similar chemistry = delicetic enzyme, cholesterol An integrated electrochemical biosynthetic polymer compound described in item 27. :: y 』范 u2! Page 27 200422608 VI. Application for Patent Compounds, Polyamine-Based High Tiller Compounds, Polyamine-Based Polymer Natural Products, Diamine-Based Compounds, Multi-Grafted Molecular Compounds, Multi-Cycle-Based South Molecular Natural Products, Di-Carboxyl Chemical substances, or similar chemicals. 2 8 · An integrated electrochemical biochemical sensing device as described in item 25 of the scope of patent application, wherein the electron transfer medium includes an electron acceptor, an electron donor, and a catalytic reagent. 2 9 · An integrated electrochemical biochemical sensing device as described in item 17 of the scope of patent application, wherein the physical reaction between the working electrode and the biological fluid sample to be measured is made of carbon-containing ink or other The conductive metal ink is made of highly conductive ink, and then passed with an appropriate and sufficient operating voltage to facilitate the electron transfer of the chemical reaction. 31 30. An integrated electrochemical biosensor device as described in item 17 of the patent scope of Shenyan, wherein the multi-channel electrochemical sensor device can be adjusted appropriately according to the species or electron transfer medium. An integrated electrochemical sensing device as described in item 17 of the scope of the patent application, wherein the reference electrode is a relative index of J, including the following:-Item C electrode material saturated calomel electrode, other As a reference electricity 32. As described in the patent application, the sensing device, in which an integrated electrochemical or other conductivity of a is a metal electrode, the material of which is carbon-containing ink: carbon, gold Made of conductive ink, including 33. Metals that resemble the scope of the patent application. The type of integrated electrochemical cells described in item 17 6. Application scope of the patented chemical sensing device, wherein the plurality of electrode groups are tested by modifying different enzyme molecules and physical parameters. # 齐 34 · As described in item 33 of the scope of application for patent application, wherein the enzyme molecules include: glucose oxidase, glucose dehydrogenase, and similar chemicals. ^ 35. One of the sensing devices as described in item 33 of the scope of the patent application, wherein 'the cross-linking test is a hydrazine molecular compound, a polyaldehyde-based polymer di autumn compound, a polyamine-based polymer compound, Polyamine formula: bis = compound, polymer compound with multiple amino groups ^ P, ^-〇, or a similar chemical In the plurality of electrode groups, the K molecule and the cross-linking reagent are used to detect multiple physiological parameters. 37. For example, the patent application scope No. 36 chemical sensing device, in which the whole type is: glucose oxidase U :: is a gasification enzyme, as described in phase 36, glucose and wind enzyme fermentation enzymes and similar chemicals 38 .: Π2 range item 36 described above-in which the crosslinking reagent can be the following Secret " sub-compounds, polyacid-based polymers, natural working electrodes, to achieve multi-synthetic electrochemical reduction enzymes, inclusions, cholesterol oxidation-type electrochemical generations: multiple substances, dialdehyde The work of β-electrochemical synthesis of molecular natural materials and polycarboxylic polymers Electrode and electrotransformation-type electrochemical bioreductive enzymes, encapsulation, cholesterol oxidation-type electrochemical biochemistry: any of the following: polyethers, dialdehydes 200422608 six 39 40. 41. 42. Application for patent scope compounds, polyamine groups Polymer compounds, polyamine-based polymer compounds, diamine-based compounds, polycarboxyl-based polymer compounds, poly-based polymers, natural products, dicarboxyl-based compounds, or similar chemical substances. An integrated electric studentized sensing device as described in the above item, wherein the electron transfer medium is a package: an electron acceptor, an electron donor, and a catalytic reagent. An integration as described in item 17 of the scope of patent application Type electro-chemical biochemical sensing device, in which the electrochemical biochemical sensing device is applied to a different working electrode group when a commercial company applies a different working voltage. An integrated electrical device as described in item 17 of the scope of patent application彳 b biochemical sensing device, wherein the electrochemical biochemical sensing device is set at different times when different working voltages are applied to different working electrode groups. For example, the scope of patent application No. 4 〇 Or one of the four items described above> Inflammatory electrochemical biochemical sensing device 'Zhongzhong' The working electrode is applied: Different: The pressure is adjusted according to different electron transfer media. '43. An integrated electrochemical biochemical sensing method includes: (1) collecting a biological fluid sample to be measured by using one of # inside a sample collecting device, that is, using external force to cooperate; ::: means to form a vacuum inside the sample bearing space; Or negative relative difference = the biological fluid sample to be tested can be quickly inserted into the product bearing Xuanjian (2) using a plurality of electrode groups of the liquid sample in the electrode to perform chemical disk electrodes, groups to be tested, and physical reactions, and each Electrode group system 20044226〇 6, 44 45 as a baggage / run-of-the-mill biological electrode and its attendance and physical reaction (3) use of post-pain work results should be used overnight Wo device, such as the physiological parameters of the patented sensing method device, a hole in the needle space, an outer hole 0 electrode, a reference electrode and an auxiliary electrode, that is, when the liquid sample enters the sample bearing space After that, the chemical substances in the work will react with the biological fluid samples to be measured; the operation logic and the already performed will be the first in the range of operations, among which the number range is clearly counted, among which the objects, shells, and 4 items Under the step display, there are 4 3 items of physiology 'in step' and this can be retrieved and calculated by a data acquisition device inverse to the results of chemical and physical reactions into one of the integrated electrochemical steps (3). Use a signal to display any item: the concentration corresponding to the fluid sample parameter of the organism to be measured. In one of the integrated electrochemical generation steps (1), the sample can be used to collect a needle to break through the sample bearing point of the sample carrying sample to generate a range of micropores, of which 4 6 A special object on the shell can be applied to a sample as described in the patented sensing method 47. The first one is a special microsphere to be used as an integrated electrochemical generator on the outer shell. 4 = In step (1), Using this sample special design to generate-micro protrusion A ,: A micro hole is generated at a load collection point. 4 One of the 3 items described above, inserting a person, Li Niu Bang⑴ + # 整 ° $ electrochemical special design produced-tiny highlights: sample. . The function of air-tight sealing is to use holes ’and to maintain the sample loading Page 31 200422608 VI. Scope of patent application 48 · Vacuum or negative pressure in space As described in the patent application method, the biological fluid sample is subjected to fermentation contained in the working surface, and oxygen molecules are used as the electrode to refer to the same modified electrode. status. 4 An integrated electrochemical reaction as described in item 3 In step (2), the chemical reaction between the chemical substance and the chemical substance to be measured is to use the working electrode to generate an electron transfer that is a biochemical reaction to the biological fluid sample to be measured. Medium, and the enzyme molecule and a suitable cross-linking reagent are a total of 4 9 · If applying for chemical sensing include: glucosamine, 50. If applying for chemical sensing aldehyde-based polymer, diamine-based natural products 5 1 · For example, the patented scope method of chemical sensing organisms, among which glucose oxidation enzyme and similar patented scope method, in which the molecular compound polyamine high-scoring compound, poly and dicarboxylization patented scope method, wherein the liquid sample is subjected to 4 8 items, the enzymes, Portuguese chemistry 4 8 items, the cross-linked polyaldehyde compounds, and 4 3 > the element molecules described in step chemistry are redox enzyme glucose dehydrogenase, Cholesterol oxygen. The integrated electrochemical reagent may be any one of the following: natural macromolecules based on natural polymers, stilbene compounds, natural polymers based on polyamines, molecular compounds, polycarboxylates, or similar chemical substances. In the integrated electrochemical step (2), the chemical substance and the reaction to be cleaned use the enzyme molecules contained on the working surface of the working electrode to react with the electrons and the biological fluid sample to be tested to transfer the medium and work The electrode refers to the place where the enzyme molecule and a suitable cross-linking reagent and a suitable electron transfer medium 200422608 Jointly modified electrodes. 5 2 · If the scope of the patent application No. 51 chemical sensing method, wherein the enzyme includes: glucose oxidase, glucosidase, and similar chemistry 5 3 · If the scope of the patent application No. 51 chemical detection method, Among them, the terminal molecular compound, multi-age compound, polyamine-based polymer compound diamine compound, polycarboxyl high-natural substance, dicarboxyl compound, 54. Such as the application of the 51st scope of the patent application method 'Among them, the integrated acceptor, electron donor, and one of the integrated electrochemical biochemical molecules described in the catalytic test are redox enzymes, glucose dehydrogenases, and cholesterol oxidizing substances. The integrated electrochemical bioreagent can be any one of the following: natural polymers based on polybasic polymers, double-layered compounds, natural materials based on polyamines, molecular compounds, polycarboxyl polymers, or similar chemical substances . The integrated electrochemical biotransmission medium includes: an electronic agent 0 5 5 · An integrated electrochemical biochemical sensing method as described in item 43 of the scope of the patent application, wherein the physical reaction between the working electrode and the biological fluid sample to be measured in step (2) is using a working electrode system Made of carbon-based ink or other conductive metal ink with high conductivity ink Then, an appropriate and sufficient operating voltage is applied to facilitate the electron transfer of the chemical reaction. 56. An integrated electrochemical biochemical sensing method as described in item 43 of the scope of patent application, wherein in step (2), the electrode group may further include a multi-channel electrochemical sensing device, which can provide at least A working voltage is applied to the working electrode. Page 33 200422608 6. Application for patent scope 5 7. An integrated electrochemical biochemical sensing method as described in item 43 of the scope of patent application, wherein the reference electrode system in step (2) can be used as the work The relative indicators of the working voltage applied by the electrode include any of the following: silver / vaporized silver reference electrode, saturated calomel electrode, and other materials that can be used as reference electrode. 5 8. An integrated electrochemical biochemical sensing method as described in item 43 of the scope of the patent application, wherein in step (2), the material of the auxiliary electrode is as high as that of carbon-containing ink or other conductive metal ink. Made of conductive ink, including: carbon, gold, platinum, similar metals. Page 34