Method and apparatus for controlled infusion via pulses having predefined discrete bolus volume to achieve a controlled infusion response pharmacokinetic

Abstract

A fluid delivery device with low mechanical compliance delivers a controlled amount of fluid via discrete fluid pulses that achieves a target drug blood concentration profile or pharmacokinetic (PK), without needing delivery to be dampened and therefore in contrast with conventional fluid delivery devices with high mechanical compliance requirements that dampen delivery to achieve a continuous delivery. The fluid delivery device operates, for example, in accordance with a pulsatile profile using an algorithm implementing a pulsatile delivery method. A pulsatile profile building method is also provided that defines the fixed interval or variable intervals in a pulsatile profile based on the PK of the drug measured (e.g., on an individual, representative model, or extracted from the PK of a population) with a single injection, and its PK is modelled using any of plural example simulation methods.

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