Method and apparatus for closed loop drug delivery

A method for varying a patient physiological variable in a closed-loop drug delivery system wherein the system has a processor that controls the delivery of the drug to the patient, comprising the steps of:

• a) defining a protocol for implementation on the processor including a first target value of the patient physiological variable and a first set of rules to achieve the first target value of the patient physiological variable,
• b) defining an alternate set of rules to achieve a second target value of the patient physiological variable, where both the first and alternate sets of rules provide a non-zero amount of drug to the patient,
• c) defining an acceptable zone of deviation from the first set of rules,
• d) initiating drug delivery at a rate defined by the first set of rules,
• e) monitoring the patient physiological variable to generate a monitored value wherein the monitored value is received by the processor, and
• f) changing from the first set of rules to the alternate set of rules if the processor determines that the monitored value of the patient physiological variable is outside the acceptable zone of deviation from the first set of rules, thereby changing the rate of the drug delivery.

A method for using closed-loop drug delivery to vary a patient physiological variable, the method using a system wherein the system has a processor that controls the delivery of the drug to the patient, the method comprising the steps of:

• a) specifying a first desired rate of change in the patient physiological variable, a second desired rate of change in the patient physiological variable, and transition conditions to indicate when to switch from the first desired rate of change to the second desired rate of change, where both the first and second desired rates of change provide a non-zero amount of drug to the patient,
• b) administering the drug which causes variation in the patient's physiological variable,
• c) monitoring the patient physiological variable wherein the monitored value is received by the processor,
• d) determining a determined rate of change in the patient physiological variable, and
• e) controlling the drug delivery in the closed-loop system whereby the determined rate of change in the patient physiological variable is adjusted by the processor toward the first desired rate of change in the patient physiological variable, and when the monitored patient physiological variable satisfies the transition conditions, the determined rate of change is adjusted by the processor toward the second desired rate of change of the patient physiological variable.

A method for closed-loop drug delivery using an exercising simulating agent drug for adjusting a heart rate, the method using a system wherein the system has a processor that controls the delivery of the drug to the patient, the method comprising the steps of:

• a) specifying for implementation on the processor i) a first protocol that includes a first target heart rate, ii) an alternate protocol that includes a second target heart rate and, iii) transition conditions for indicating whether to switch from the first protocol to the second protocol,
• b) establishing a baseline heart rate approximately equal to the patient's average heart rate at the initial start of drug administration,
• c) determining the individual patient response to the drug, including, monitoring the heart rate to find a monitored heart rate, wherein the monitored heart rate is received by the processor,
• d) adjusting the ad ministration of the drug based upon:
• i) the first protocol, or the second protocol when transition conditions are met, ii) the baseline heart rate, iii) the monitored heart rate, and iv) the individual patient response,
• e) collecting patient specific data about the patient response to the drug, and
• f) outputting the patient specific data about the patient response to the drug.

A method for determining when a target heart rate has been achieved in a closed-loop drug delivery system wherein the system has a processor that controls the delivery of the drug to the patient, comprising the steps of:

• initiate drug delivery,
• monitor the patient heart rate wherein the monitored heart is received by the processor,
• determine the slope of the patient heart rate,
• generate a threshold to target value based in part on the heart rate slope, wherein the threshold to target value represents an acceptable deviation from the target heart rate, and
• terminate drug delivery when the processor determines that the patient heart rate exceeds the target heart rate minus the threshold to target value.