Abstract: An integrated patient monitoring and control system is provided which includes a closed-loop control system for monitoring and adjusting the heparin infusion rate for a patient. The system includes a processor which uses a dynamic patient model that is continuously adjusted based on the patient's aPTT measurements to calculate an optimal heparin infusion rate to achieve an operator-input aPTT target range. The processor also includes a forecasting model to calculate the optimum sample time interval for measuring the patient's aPTT to calculate a new infusion rate. An automated sampling system, which includes a storage device for storing a series of assay devices, an advancement mechanism for moving the assay devices to a sample area, and a measurement device for analyzing a sample dispensed on the assay, is provided. The sampling system is used to repeatedly measure the patient's aPTT according to the sample time interval determined by the processor.

Abstract: A closed-loop drug delivery system uses patient response and rule based decision making methods to achieve operator specified responses for diagnostic purposes. In the preferred embodiment, cardiac diagnosis is performed by pharmacologically stressing the heart by administration of an exercise simulating agent drug. In the preferred method, a protocol is defined, which preferably includes a target for a physiologic variable, such as heart rate, and a plan to achieve that target value. Preferably, the plan includes a specification of the desired rate of increase in that variable, such as the rate of increase in the heart rate per minute. The plan comprises the desired changes in the physiologic variable as a function of time. While any desired function may be used, the more common modes include RAMP, HOLD, LEVEL and TARGET mode. In one aspect of this invention, the protocol may be varied by the operator after drug administration has begun.

Abstract: A feedback controlled drug delivery system includes automated blood sampling and analysis and dosing of the patient. Automated sampling is performed by direct analysis of patient blood, such as for measurement of its coagulation state. A novel manifold includes a fluid input port, a patient port adapted to output fluid and to receive a blood sample from the patient, and a fluid pathway connecting the fluid port and the patient port. A sample line is connected to the fluid pathway to provide the sample to an analyzer. In one aspect of this invention, the sample is forced through the sample line by isolating the patient port, such as by a valve, and non-drug fluid is forced into the manifold causing the blood to cross through the sample line. Alternately, a pump force may be utilized on the sample line. In another aspect of this invention, a positive interlock system is utilized between a drug source and the system.