专利汇可以提供Apparatus and method for integral electrochemical biosensor专利检索,专利查询,专利分析的服务。并且The present invention relates to offer an apparatus and a method for an integral electrochemical biosensor combining designs of blood sampling, continuous and multiply testing, multi-channel detecting and adjustable working voltage; furthermore several physiologic parameters can be obtained simultaneously in an identical testing. The invention provides convenience for users and improves the practicability. Said integral electrochemical biosensor comprises: at least a sampling device configured to supply a sample carrying room, which is in vacuum or a state of relative negative pressure by an applied force with a pressure difference to make inactive humor at a relative high pressure injecting into said sample carrying room; a plurality of electrode sets comprising a compared electrode, an assisting electrode and an operating electrode, on which chemical and/or physical reactions between said inactive humor and chemicals bring out after said inactive humor injecting into said sample carrying room; a multi-channel electrochemical detector configured to provide several choices of operating voltage for said operating electrodes; a logic and data device configured to grab and calculate data of result from said physical or/and chemical reactions; a signal displaying device configured to explicitly show physiological parameter values of said inactive humor and corresponding concentration of said physiological parameters.,下面是Apparatus and method for integral electrochemical biosensor专利的具体信息内容。
1. Field of the Invention
The present invention is related to an apparatus and a method for an integral electrochemical biosensor, especially for an integral module related to multiply and various biochemical testing.
2. Description of the Prior Art
A biosensor or a bio-electronic is related to a device, which detects or tests by functions and characteristics of a bio-molecule; wherein said biosensor utilizes a bio-molecule, such as protein, gene, enzyme, antibody and nucleic acid, as a recognizing element and said bio-electronic, composed of a conventional inorganic semiconductor, such as a silicon chip, on which coated a specific biomaterial, such as protein, links up signal transmitting, processing and calculating with each other after a specific biochemical reaction of said biomaterial with other matters and is applied in several fields, such as testing in medical and comestibles, monitoring in the agricultural, the environmental, the industrial and the pharmaceutical.
With a worldwide trend of the society of senility, there is a rapid development in the in-house nursing medical device and an excess demand for an in-house, portable and private physiological biosensor, for instance, the development in glucose biosensors and glycoprotein biosensors to test physiological parameters for diabetics, uric acid biosensors to test physiological parameters for gouty arthritis, biosensors to test relative physiological parameters, such as the content of triglyceride and cholesterol for cardiovascular diseases and an oximeter to test the concentration of oxygen dissolved in blood and a portable cardiograph for the cardiopulmonary; wherein the development in relative testing for diabetics is paid the most attention. For an increasing amount of patients and no effective prescription for diabetes, which is a kind of chronic disease, it takes a lot of time and money for people to diagnose and give treatment. The health insurance system in America spends more than 100 billion dollars per year on diagnosing and remedy for diabetes and cost of unemployment relative to the disease is more considerable. Both of the World Health Organization and the U.S. Center for Disease Control have sent warnings of the rapidly increasing amount of diabetics in the world.
For knowing the health of patients suffering from chronic diseases, time and long-term traced measurements for concentration of said physiological parameter in blood are undoubtedly imperative, which is the most accurate way at the present day. A kind of non-intrusive watch-like sensor has developed and been identified by FDA, however, this kind of sensor is related to test the physiological parameter in perspiration and is easily affected by the environmental condition and the patient's irregular sweating; this may lead to an imprecise testing result, which needs a further comparison with the conventional sensor. Therefore, it is still a common means in the present market to receive an injection of blood for testing.
Besides, a variety of complications of patients, who are suffering from chronic diseases, is not derivable from testing single physiological parameter in blood. It is important for said chronic disease patients to have a multi-parameter sensor. For instance, accompanying with a physiological test of perilous factors for cardiovascular diseases, the uric acid content in blood is another indispensable physiological parameter; because of advancement in the society and a change in diet habit, diseases relative to said uric acid persecute a variety of patients. However, there are few in-house or private multi-parameter sensors developed. Most in-house, portable and private physiological parameter sensors have to be used combining with blood sampling device and various testing specimen is used for different physiological parameter testing; furthermore, testing modules have to be replaced to obtain different physiological parameters; it is really not convenient for use.
The present invention relates to offer an all-in-one multi-channel electrochemical biosensor, combining designs of blood sampling, continuous and multiply testing, multi-channel detecting and adjustable working voltage; several physiological parameters can be obtained simultaneously in an identical test. The invention provides convenience for users and improves the practicability.
The present invention, integrating a blood sampling device and testing programs in a bio-test, relates to provide a mechanism for continuous and multiply testing; furthermore, several physiological parameters can be tested simultaneously in a single testing and this offers the convenience and simplicity in use. In the known technique, blood sampling device and testing programs are always separate from each other; therefore, users have to expose skin by a sampling needle to gather blood and prepare a clean specimen to get enough amounts of blood sample for testing and analysis. Knowing form the foregoing description, said users have to prepare a blood-sampling device, specimens and sensors momently and it is obviously portably inconvenient. Additionally, because only one parameter can be obtained from a single testing, the above testing process have to be repeated when needing to test different physiological parameters; this leads to be short of the convenience in use. Furthermore, it is one another besetment for discard and post-treatment for used blood sampling devices and specimens.
Based on the foregoing reasons, the present invention provides an integral electrochemical biosensor, which relates to combine designs of a blood sampling device, specimens and sensors. Various testing for different physiological parameters can be finished at the moment of blood sampling by this invention, which offers users a more convenient and ponderable service. The invention also offers an operating interface of continuous multiply testing and thus said users do not have to carry a variety of apparatus, such as blood sampling needles and testing papers, at one time; it increases the convenience in use, broadens the application of biosensors and promotes the competitiveness of the biotechnology industry.
The present invention related to an integral electrochemical biosensor, which combines designs of a blood sampling device, specimens and sensors, needs no additional blood sampling means and testing specimens and can furthermore test several physiological parameters simultaneously. One another distinguishing feature of the invention is multiply testing without replacing said specimen for that each testing region can work independently and does not affect each other. Moreover, users do not have to take along other relative apparatus while using said biosensor of the invention, which increases the convenience in use and improve the practicability.
People skilled in physiological biosensor industry know that a variety of biosensors for the same purpose have been ripely developed. The products in the present market are most related to a blood glucose testing, including All-In-One BD Latitude™ Diabetes Management System developed by the Becton Diskinson, Precision QID blood sugar meter developed by the New BD Logic™ Blood Glucose Monitor and Medisense and Elite blood glucose meter developed by the Bayer, series of products for blood glucose analysis developed by the Hypoguard, Ultra meter developed by the Lifescan and Accu-Chek Compact meter developed by the Roche etc., and related to testing for uric acid concentration in blood and relative factors for cardiovascular diseases, such as CardioCheck P. A™ series products developed by the Polymer Technology System Inc. However, most of these testing apparatus need collocating an additional blood sampling device and specific testing paper and moreover, different testing or calculating modules have to be exchanged for a specific physiological parameter test.
All-In-One BD Latitude™ Diabetes Management System, developed by the Becton Diskinson, relates to combine and encase components of blood sampling devices, testing specimens and sensors. This design makes it convenient to use for the patients, however, said components still have to be used separately. Another small part relates to combine blood sampling devices, testing papers and sensors, such as Sof-Tact™ blood glucose meter configured to put a sampling needle and a testing specimen in said meter and enabled to plan an advance schedule for testing. Besides, a small-scale vacuum pump is applied for blood sampling in this system. When said meter is pressed close to and contacts skin, the skin will be sucked by said vacuum pump and exposed by said sampling needle at the moment. By functioning of said vacuum pump, blood will flow out rapidly, be gathered by said testing specimen and then tested for a physiological parameter directly. In addition, a combination of PDA is also considered for a patient to take medicine and monitor pathology; this makes said patient to record medicine taking hours and to know variation of the personal physiological parameters well, for instance, OneTouch®UltraSmar™ Blood Glucose Monitoring System developed by the Lifescan, a personal diabetes management system, which relates to combined input means for the personal health, morbidity, dosage, diet and result of blood glucose testing, FreeStyle Tracker system developed by the TheraSense, a new glucose testing instrument related to combine digital functions of the present testing result, results in the past and results on that day with PDA and be identified by FDA.
Other and further features, advantages and benefits of the invention will become apparent in the following description taken in conjunction with the following drawings. It is to be understood that the foregoing general description and following detailed description are exemplary and explanatory but are not to be restrictive of the invention. The accompanying drawings are incorporated in and constitute a part of this application and, together with the description, serve to explain the principles of the invention in general terms. Like numerals refer to like parts throughout the disclosure.
The objects, spirits and advantages of the preferred embodiments of the present invention will be readily understood by the accompanying drawings and detailed descriptions, wherein:
The present invention is characterized by an integral electrochemical biosensor, which has advantages of blood sampling, testing, signal output and continuous testing needing no fitting exchanging. This is an innovation for the testing technique. Products in the present market are all configured to work said blood sampling, said testing specimen and said testing separately, that each cannot be lacking while using. Users have to repeat steps of sampling, blood gathering and testing for multiple or various tests. Therefore, the present invention integrates the above separate elements to make said integral electrochemical biosensor to have advantages of easy to operate, convenient to carry and continuous testing without fitting exchanging.
Blood sampling of the present invention relates to work by means of pressure difference. The testing area of said sensor is in vacuum or a state of negative pressure. When a user puts his testing region onto/into the testing area, a micro sampling device in said testing area will poke in skin of the testing region; because of the vacuum or negative pressure state in said testing area, space of said testing area is quickly filled with blood flowing through skin poked by said sampling device and blood will stop filling until an equilibrium of internal and external pressure is reached. Therefore, amount of said blood for testing can be quantitatively determined in this way.
With reference to
With reference to
In the embodiment, however, two kinds of operating electrodes are involved in said plurality of electrode sets. One is related to work testing for multiple physiological parameters by decoration of various enzymes and cross-linking reagents and the other is by decoration of various enzymes, cross-linking reagents and electron transferring mediums.
Taking glucose testing for example, reaction between bio-molecules and transference of electron are show in the following:
Generally speaking, oxygen molecule is taken to be an electron accepter in an enzyme bio-reaction and the transference of electron is described in the following:
Therefore, concentration of glucose can be quantitatively determined by measuring amounts of oxygen consumed or hydrogen peroxide produced. Said electron acceptor can be other chemicals, such as Ferrocene, K3Fe(CN)6 and TTF-FCNQ.
Taking K3Fe(CN)6 for example, the transference of electron is described in the following:
Wherein, concentration of glucose can be quantitatively determined by detecting the transference of electron between Fe(CN)63− and Fe(CN)64−.
In addition, concentration of glucose can be quantitatively determined by measuring amounts of hydrogen peroxide produced. For instance, Prussian Blue is used to be a catalyst for decomposing said hydrogen peroxide and the transference of electron is described in the following:
This mechanism relates to quantitatively determine glucose concentration by detecting the electron transferring in reduction of said hydrogen peroxide. Other electrode sets work for one another testing and testing specificity of said various electrode sets is identified by enzymes or bio-molecules on said operating electrode. Goal for specific testing of various physiological parameters is attained by means of natural selectivity and specificity to an inactive sample by said bio-molecules.
In addition, a multi-channel electrochemical detector of the present invention can separately offer different operating voltage to various electrode sets and said operating voltage is adapted to different electron transferring medium or to tell different physiological parameters from each other; furthermore, concentration of various parameters in a body is different and basic characteristics of a corresponding bio-molecule is not the same, and therefore, various logic calculating method, which can calculate separately, is designed for said different electrode sets and signals of result analyzed can be shown on a displayer by electric lines.
Taking
Taking
With reference to
With reference to
With reference to
Although this invention has been disclosed and illustrated with reference to particular embodiments, the principles involved are susceptible for use in numerous other embodiments that will be apparent to persons skilled in the art. This invention is, therefore, to be limited only as indicated by the scope of the appended claims.
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