Disposable analytical microprocessor device

Abstract

The present invention generally relates to the determination of an analyte concentration (quantitative determination) or whether an analyte threshold level has been passed (qualitative determination) in a biological sample through employment of a disposable analytical microprocessor device. The device can include a batch-specific, self-executable algorithm for the calculation of the analyte concentration.

1 . A disposable analytical microprocessor device capable of reversible engagement with a sensing meter such that said disposable analytical microprocessor device and said sensing meter are capable of bidirectional transfer of date, and said disposable analytical microprocessor device further comprises;
 a) at least one stored batch-specific disposable consumable parameter value;   b) a microprocessor; and   c) at least one self-executable algorithm able to calculate an analyte concentration value using date received from the sensing meter in combination with said stored batch-specific date, and transfer said value to said sensing meter.   
     
     
         2 . The device of  claim 1  wherein said device comprises a one-chip microcomputer which comprises said microprocessor. 
     
     
         3 . The device as recited in  claim 1  wherein said reversible engagement serial, parallel, or a combination thereof, bidirectional transfer of said data. 
     
     
         4 . The device as recited in  claim 1  wherein said reversible engagement provides electrical connectivity and further provides said microprocessor with a clock pulse from an oscillator in said sensing meter. 
     
     
         5 . The device as recited in  claim 1  wherein said reversible engagement is optical and enables serial, parallel, or a combination thereof, bidirectional transfer of said data. 
     
     
         6 . The device as recited in  claim 1  wherein said self-executable algorithm is based on a reference table conversion, or on a mathematical function approximation wherein said mathematical function is selected from the group comprised of: a linear function, a polynomial function, a logarithmic function, an exponential function, and a trigonometric function. 
     
     
         7 . The device as recited in  claim 1  wherein said stored batch specific parameter values or said self-executable algorithm are stored in an internal memory of said one-chip microcomputer or in a separate RAM, ROM, EPROM, or EEPROM-based memory chip in said disposable analytical microprocessor device. 
     
     
         8 . The device as recited in  claim 1  wherein said stored batch specific parameter values are comprised of information relating to at least one parameter chosen from the group comprised of: specific analyte calculation performance of a batch of disposable consumables, mathematical approximation formulas, encryption keys, analyte name in ASCI-code, the production batch number, the batch production date, the batch expiration date, number of measurements allowed, analyte identification data, the dates when each individual disposable consumable was used, the remaining number of disposable consumables in the end-user package, the individual identification number of said sensing meter used, the individual identification of the person operating said sensing mater, measuring/timing protocols, and high-low alarm level analyte concentration values. 
     
     
         9 . The device as recited in  claim 1  wherein said stored parameter values further include an encrypted key for secure data transfer between said microprocessor and said sensing meter. 
     
     
         10 . The device as recited in  claim 1  wherein said device further includes a battery powered electronic date chip containing a real-time clock and a calendar which provides internal time and date information to said self-executable algorithm. 
     
     
         11 . The device as recited in  claim 1  wherein said self-executable algorithm execution is disabled by changing from its active operating state to its non-active state operation state when a condition selected from the following group is reached; said stored parameter values or said data show that a predetermined number of used disposable consumables has been exceeded; the expiration date of the batch has been exceeded; the individual identification number of said sensing meter used has been changed; the said encrypted key does not corresponds to the encrypted key in the said sensing meter; and a measuring procedure error has been reported from said sensing meter. 
     
     
         12 . A system for quantitative and qualitative determination of analytes in a biological sample, comprised of the device of  claim 1  and a sensing meter. 
     
     
         13 . The system of  claim 12  wherein said sensing meter further includes means for measuring magnetic permeability changes in said disposable consumables when exposed to said analyte, and for outputting signals to said microprocessor indicative of manifestations of a chemical or physical reaction in said disposable reagent vials or strips. 
     
     
         14 . The system as recited in  claim 12  wherein the said sensing meter further includes means for measuring optical changes such as absorbance, polarization, fluorescence, electrochemi-luminescence, turbidity, nephelometric, or refractometric in disposable reagent vials or strips when exposed to said analyte, and for outputting signals to said microprocessor indicative of manifestations of a chemical or physical reaction in said disposable consumables. 
     
     
         15 . The system as recited in  claim 12  wherein said sensing meter further includes means for measuring electrochemical changes such as in amperometry, polarometry or conductometry in disposable reagent vials or strips when exposed to said analyte, and for outputting signals to said microprocessor indicative of manifestations or a chemical or physical reaction in said disposable consumables. 
     
     
         16 . The system as recited in  claim 12  wherein said sensing meter further includes means for measuring mass changes in disposable reagent vials or strips when exposed to said analyte, and for outputting signals to said microprocessor indicative of manifestations of a chemical or physical reaction in said disposable consumables. 
     
     
         17 . The system as recited in  claim 12  wherein said sensing meter further includes sense means for measuring piezoelectric changes or surface plasmon effects in disposable reagent vials or strips when exposed to said analyte, and for outputting signals to said microprocessor indicative of manifestations of a chemical or physical reaction in said disposable consumables. 
     
     
         18 . The system as recited in  claim 12  wherein said sensing meter further includes sense means for measuring any of the analytes glucose, albumin, hemoglobin (Hb and HbA1C), myoglobin, troponin (I and T), CK-MB, creatinine kinase (CK), d-dimer, β-type natriuretic peptide (BNP and pro BNP), n-terminal prohormone peptide (NT-proBNP), C-reactive protein (hsCRP and CRP), cystatin C, prothrombin, activated partial thromboplastin (APTT), HCG, LH, FSH, PSA, TSH, T3, T4, AFP, CEA, low density lipoprotein (LDL), High density lipoprotein (HDL), triglycerides, cholesterol, antibodies,  Streptococcus A, Helicobactor Pylori, Salmonella, Chlamydia, Giardia , chlorea, hepatitis (A, B and C), adenovirus, rotavirus or any combination thereof with said disposable consumables when exposed to said analyte, and for outputting signals to said processor chip indicative of manifestations of a chemical or physical reaction in said disposable consumables. 
     
     
         19 . The system as recited in  claim 12  wherein the said sensing meter further includes an electronic date chip containing a real-time clock and a calendar which provides time and date information to the said self-executable algorithm. 
     
     
         20 . A method for determining an analyte concentration in a biological sample, such method comprising;
 (a) Applying a biological sample to a disposable consumable; and   (b) Introducing said disposable consumable to the device as recited in  claim 1 .