Electrolysis: processes – compositions used therein – and methods – Electrolytic analysis or testing – Involving enzyme or micro-organism
Patent
1995-02-02
1996-04-09
Bell, Bruce F.
Electrolysis: processes, compositions used therein, and methods
Electrolytic analysis or testing
Involving enzyme or micro-organism
204403, 204409, 204412, 204416, 204419, 204433, 128635, 128760, 205779, 2057815, 205782, 2057875, G01N 2726
Patent
active
055058280
DESCRIPTION:
BRIEF SUMMARY
This invention relates to the diagnostic testing of body fluids, typically in conjunction with the infusion of fluids. In a particular aspect, the invention relates to calibration solutions useful with low-cost, disposable, sensor assemblies used in automated bedside monitors.
BACKGROUND OF THE INVENTION
Low-cost, disposable, electrochemical electrode assemblies have special utility as part of infusion fluid delivery systems commonly used in hospital patient care. Such systems infuse nutrients, medications, and the like directly into the patient at a controlled rate and in precise quantities for maximum effectiveness. Infusion fluid delivery systems are connected to a patient at an intravenous (IV) port, in which a hollow needle/catheter combination is inserted into a blood vessel of the patient and thereafter an infusion fluid is introduced into the vessel at a controlled rate, typically using a peristaltic pump. Blood chemistry monitoring systems that are combined with infusion delivery systems of this kind use the IV port to periodically withdraw a blood sample, perform measurements of blood ion concentrations and the like, and then discard the blood or reinfuse it into the patient. The system then resumes delivery of the infusion fluid.
Such combined infusion fluid delivery and blood chemistry monitoring systems include an infusion line and catheter through which the infusion fluid is provided to the patient and blood samples are withdrawn. The infusion line incorporates an electrode assembly having electrochemical sensors that are periodically exposed to the blood samples and thereby provide electrical signals to an analyzer for conversion into corresponding blood chemistry data. A control unit periodically halts delivery of the infusion fluid for a brief interval, during which time a blood sample is withdrawn from the patient into the infusion line and routed to the electrode assembly, which then generates the electrical signals. After the electrical signals have been received by the analyzer, the control unit disposes of the blood or reinfuses the blood sample into the patient, and the flow of infusion fluid is resumed.
The electrode assembly typically, among other types of electrochemical sensors, includes a reference electrode and a plurality of sensing electrodes (sensors) that are each sensitive to a particular ion or species of interest. All of the electrodes are typically embedded in the base of the electrode assembly. For example, ion-sensitive electrodes (ISE) generate electrical signals only in response to contact with the particular ion to which they are sensitive, and therefore provide selective measurement of the amount of that ion in the blood. This type of sensing electrode can be provided to measure, for example, blood calcium, hydrogen ion, chloride, potassium, and sodium. In a differential measurement system, the reference electrode might be another ion-selective electrode (e.g., a chloride or sodium electrode) that is continuously exposed to a calibration or reference fluid. Alternatively, in a non-differential measurement system, a conventional reference electrode (which maintains a fixed potential when exposed either to reference fluid or to analyte) is required.
In a differential measurement system, during the delivery of calibration fluid, the calibration fluid flows past both the reference electrode and the sensing electrodes, and the electrical potential between the reference electrode and each sensing electrode is measured. This provides a calibration measurement of the electrode assembly. During a subsequent blood chemistry measurement, a blood sample is drawn into the electrode assembly, where it comes into contact with the sensing electrodes, but not the reference electrode. The electrical potential between the reference electrode and each sensing electrode is measured again and compared with the earlier calibration measurement to provide an indication of the ion concentration in the blood of the particular ion to which the sensing electrode is sensitive. After measure
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Curry Kenneth M.
Wong David K.
Bell Bruce F.
Reiter Stephen E.
Via Medical Corporation
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