Electrolysis: processes – compositions used therein – and methods – Electrolytic analysis or testing – Of biological material
Reexamination Certificate
2000-04-24
2003-11-11
Tung, T. (Department: 1743)
Electrolysis: processes, compositions used therein, and methods
Electrolytic analysis or testing
Of biological material
C205S777500, C204S403010, C204S401000, C422S082010
Reexamination Certificate
active
06645368
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to methods and apparatus for improving the accuracy of measurements made with instruments of the type described in, for example, U.S. Patents: U.S. Pat. Nos. 5,243,516; 5,288,636; 5,352,351; 5,385,846; and 5,508,171. The invention is disclosed in the context of such an instrument, but is believed to be useful in other instruments of this general type as well.
There are a number of instruments for the determination of the concentrations of biologically significant components of bodily fluids, such as, for example, the glucose concentration of blood. There are, for example, the instruments described in U.S. Patents: U.S. Pat. Nos. 3,770,607; 3,838,033; 3,902,970; 3,925,183; 3,937,615; 4,005,002; 4,040,908; 4,086,631; 4,123,701; 4,127,448; 4,214,968; 4,217,196; 4,224,125; 4,225,410; 4,230,537; 4,260,680; 4,263,343; 4,265,250; 4,273,134; 4,301,412; 4,303,887; 4,366,033; 4,407,959; 4,413,628; 4,420,564; 4,431,004; 4,436,094; 4,440,175; 4,477,314; 4,477,575; 4,499,423; 4,517,291; 4,654,197; 4,671,288; 4,679,562; 4,682,602; 4,703,756; 4,711,245; 4,734,184; 4,750,496; 4,759,828; 4,789,804; 4,795,542; 4,805,624; 4,816,224; 4,820,399; 4,897,162; 4,897,173; 4,919,770; 4,927,516; 4,935,106; 4,938,860; 4,940,945; 4,970,145; 4,975,647; 4,999,582; 4,999,632; 5,108,564; 5,128,015; 5,243,516; 5,269,891; 5,288,636; 5,312,762; 5,352,351; 5,385,846; 5,395,504; 5,469,846; 5,508,171; 5,508,203; and 5,509,410: German Patent Specification 3,228,542: European Patent Specifications: 206,218; 230,472; 241,309; 255,291; and, 471,986: and, Japanese Published Patent Applications JP 63-128,252 and 63-111,453. There are also the methods and apparatus described in: Talbott, et al, “A New Microchemical Approach to Amperometric Analysis,” Microchemical Journal, Vol. 37, pp. 5-12 (1988); Morris, et al, “An Electrochemical Capillary Fill Device for the Analysis of Glucose Incorporating Glucose Oxidase and Ruthenium (III) Hexamine as Mediator, Electroanalysis,” Vol. 4, pp. 1-9 (1992); Cass, et al, “Ferrocene-Mediated Enzyme Electrode for Amperometric Determination of Glucose,” Anal. Chem., Vol. 56, pp. 667-671 (1984); Zhao, “Contributions of Suspending Medium to Electrical Impedance of Blood,” Biochimica et Biophysica Acta, Vol. 1201, pp. 179-185 (1994); Zhao, “Electrical Impedance and Haematocrit of Human Blood with Various Anticoagulants,” Physiol. Meas., Vol. 14, pp. 299-307 (1993); Muller, et al., “Influence of Hematocrit and Platelet Count on Impedance and Reactivity of Whole Blood for Electrical Aggregometry,“Journal of Pharmacological and Toxicological Methods, Vol. 34, pp. 17-22 (1995); Preidel, et al, ” In Vitro Measurements with Electrocatalytic Glucose Sensor in Blood,” Biomed. Biochim. Acta, Vol. 48, pp. 897-903 (1989); Preidel, et al, “Glucose Measurements by Electrocatalytic Sensor in the Extracorporeal Blood Circulation of a Sheep,” Sensors and Actuators B, Vol. 2, pp.257-263 (1990); Saeger, et al, “Influence of Urea on the Glucose Measurement by Electrocatalytic Sensor in the Extracorporeal Blood Circulation of a Sheep,” Biomed. Biochim. Acta, Vol. 50, pp. 885-891 (1991); Kasapbasioglu, et al, “An Impedance Based Ultra-Thin Platinum Island Film Glucose Sensor,” Sensors and Actuators B, Vol. 13-14, pp. 749-751 (1993); Beyer, et al, “Development and Application of a New Enzyme Sensor Type Based on the EIS-Capacitance Structure for Bioprocess Control,” Biosensors & Bioelectronics, Vol. 9, pp. 17-21 (1994); Mohri, et al, “Characteristic Response of Electrochemical Nonlinearity to Taste Compounds with a Gold Electrode Modified with 4-Aminobenzenethiol,” Bull. Chem. Soc. Jpn., Vol. 66, pp. 1328-1332 (1993); Cardosi, et al, “The Realization of Electron Transfer from Biological Molecules to Electrodes,”
Biosensors Fundamentals and Applications,
chapt. 15 (Turner, et al, eds., Oxford University Press, 1987); Mell, et al, “Amperometric Response Enhancement of the Immobilized Glucose Oxidase Enzyme Electrode,” Analytical Chemistry, Vol. 48, pp. 1597-1601 (Sept. 1976); Mell, et al, “A Model for the Amperometric Enzyme Electrode Obtained Through Digital Simulation and Applied to the Immobilized Glucose Oxidase System,” Analytical Chemistry, Vol. 47, pp. 299-307 (Feb. 1975); Myland, et al, “Membrane-Covered Oxygen Sensors: An Exact Treatment of the Switch-on Transient,” Journal of the Electrochemical Society, Vol. 131, pp. 1815-1823 (Aug. 1984); Bradley, et al, “Kinetic Analysis of Enzyme Electrode Response,” Anal. Chem., Vol. 56, pp. 664-667 (1984); Koichi,“Measurements of Current-Potential Curves, 6, Cottrell Equation and its Analogs. What Can We Know from Chronoamperometry?” Denki Kagaku oyobi Kogyo Butsuri Kagaku, Vol. 54, no.6, pp. 471-5 (1986); Williams, et al, “Electrochemical-Enzymatic Analysis of Blood Glucose and Lactate,” Analytical Chemistry, Vol. 42, no. 1, pp. 118-121 (Jan. 1970); and, Gebhardt, et al, “Electrocatalytic Glucose Sensor,” Siemens Forsch.-u. Entwickl.-Ber. Bd., Vol. 12, pp.91-95 (1983). This listing is not intended as a representation that a complete search of all relevant prior art has been conducted, or that no better references than those listed exist. Nor should any such representation be inferred.
DISCLOSURE OF THE INVENTION
According to one aspect of the invention, an apparatus for determining the concentration of a medically significant component of a biological fluid comprises a cell for receiving a sample of the fluid. The cell supports a chemistry which reacts with the medically significant component and first and second terminals across which the reaction of the chemistry with the medically significant component can be assessed. The apparatus further comprises an instrument having first and second terminals complementary to the first and second terminals, respectively, of the cell. Placement of the first and second terminals of the cell in contact with the first and second terminals, respectively, of the instrument permits the instrument to assess the reaction. The instrument includes an assessment controller for applying across the first and second terminals of the instrument a first signal, determining a first response of the cell to the first signal, and determining based upon the first response whether to proceed with the determination of the concentration of the medically significant component of the biological fluid.
According to another aspect of the invention, an apparatus for determining the concentration of a medically significant component of a biological fluid comprises a cell for receiving a sample of the fluid. The cell supports a chemistry which reacts with the medically significant component and first and second terminals across which the reaction of the chemistry with the medically significant component can be assessed. The apparatus further comprises an instrument having first and second terminals complementary to the first and second terminals, respectively, of the cell. Placement of the first and second terminals of the cell in contact with the first and second terminals, respectively, of the instrument permits the instrument to assess the reaction. The instrument includes an assessment controller for applying across the first and second terminals of the instrument a first signal, determining a first correction value in response of the cell to the first signal, assessing the reaction of the medically significant component with the chemistry and combining the correction value with the result of the reaction assessment to produce an indication of the concentration of the medically significant component in the sample.
According to another aspect of the invention, an apparatus for determining the concentration of a medically significant component of a biological fluid comprises a cell for receiving a sample of the fluid. The cell supports a chemistry which reacts with the medically significant component and first and second terminals across which the reaction of the chemistry with the medically significant component can be assessed. The apparatus further comprises an instrument having first and seco
Beaty Terry Allen
Burke David W.
Kuhn Lance Scott
Svetnik Vladimir
Barnes & Thornburg
Noguerola Alex
Roche Diagnostics Corporation
Tung T.
LandOfFree
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