Method and device for detection of bioavailable drug concentration in a fluid sample
Inventors
Chaum, Edward • Lindner, Erno • Guo, Jidong
Assignees
University of Memphis • University of Tennessee Research Foundation • United States Department of the Army
Publication Number
US-9700246-B2
Publication Date
2017-07-11
Expiration Date
2029-10-15
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Abstract
The invention relates to a method for the controlled delivery of a drug as a function of bioavailable drug concentration, a sensor device for detecting bioavailable drug concentration, and a delivery device that controls delivery of the drug based on the real-time detection of bioavailable drug concentration.
Core Innovation
The invention relates to a method for the controlled delivery of a drug as a function of bioavailable drug concentration, a sensor device for detecting bioavailable drug concentration, and a delivery device that controls delivery of the drug based on the real-time detection of bioavailable drug concentration. It provides an electrochemical sensor including two or more electrodes surrounded by a coating comprising a structural component, a water immiscible organic solvent, and a charge transfer component, allowing selective partitioning of an electrochemically active drug and measurement of oxidation/reduction current to determine bioavailable drug concentration.
The invention also covers an indwelling catheter incorporating such sensors to detect bioavailable drug concentration in blood vessels, a target-controlled infusion drug delivery device coupled with these sensors to modulate drug delivery in real time, and methods of electrochemical detection and drug delivery modulation using the sensor or sensor array, both ex vivo and in vivo.
The problem addressed arises from the limitations of prior art Target Controlled Infusion (TCI) devices that rely on pharmacokinetic models, which do not allow for consideration of individual patient responses and only approximate drug concentration and effect-time profiles. Known devices face deficiencies in accurately detecting bioavailable drug concentration and controlling drug delivery accordingly, necessitating a sensor device and delivery system that provide accurate real-time monitoring and direct feedback control to optimize drug dosing for various medical indications.
Claims Coverage
The patent includes multiple independent claims focusing on electrochemical sensor devices, catheters incorporating these sensors, and microfluidic devices incorporating the sensors. The claims describe key inventive features related to the sensor composition, construction, and function.
Electrochemical voltammetric sensor device with specific water-immiscible coating composition
An electrochemical voltammetric sensor device comprising two or more electrodes surrounded by a water-immiscible coating containing about 15 to about 67 wt percent polyvinylchloride (PVC), about 33 to about 85 wt percent 2-nitrophenyl octyl ether (o-NPOE), and about 0.001 to about 15 wt percent tetradecylammonium tetrakis(pentofluorophenyl)borate (TDATPFPB). The coating partitions a hydrophobic drug from a fluid sample, where the partitioned drug is oxidized within the coating and the electrodes measure an oxidation/reduction current indicating drug concentration.
Electrode composition and configuration in the sensor device
The electrodes in the sensor device comprise working, reference, and counter electrodes, with embodiments including a glassy carbon working electrode, a silver reference electrode, and a platinum counter electrode.
Catheter incorporating the electrochemical sensor with water-immiscible coating capable of direct drug partitioning
A catheter comprising a body and lumen and an electrochemical voltammetric sensor device as claimed, where the sensor is in communication with the lumen or external to the body and the coating is capable of partitioning a bioavailable drug directly from a body fluid.
Microfluidic device incorporating the electrochemical voltammetric sensor
A microfluidic device comprising a microfluidic channel and an electrochemical voltammetric sensor device in communication with the microfluidic channel, enabling detection of bioavailable drug concentration in fluid passing through the channel.
The independent claims collectively cover electrochemical sensor devices with specific coating compositions and electrode configurations designed for selective drug partitioning and detection, catheters embedding such sensors for in vivo detection, and microfluidic devices incorporating these sensors for ex vivo or in-line monitoring, providing comprehensive coverage of the invention's core sensor technology and its integration into drug delivery systems.
Stated Advantages
Accurate quantification of bioavailable drug concentration can be achieved rapidly, within about 30 seconds, suitable for real-time monitoring.
The coated electrodes prevent interference from chloride ions and other molecules such as acetaminophen and Vitamin C, enhancing sensor specificity.
Sensor arrays overcome biofouling by employing a plurality of working electrodes, each used once or twice, enabling repeated measurements without degradation of signal.
Integration into indwelling catheters and microfluidic devices allows continuous or periodic real-time monitoring in vivo or ex vivo.
Enables direct feedback control of drug delivery devices based on measured bioavailable drug concentration, rather than relying solely on pharmacokinetic models, potentially improving safety and efficacy of drug dosing.
Documented Applications
Control of intravenous sedation and anesthesia drug delivery during surgical procedures, with continuous monitoring and real-time feedback modulation of drug infusion rates.
Use in intensive care or post-operative care settings to regulate drug delivery based on bioavailable drug concentration in patient fluids.
Integration into indwelling catheters for in vivo blood monitoring of bioavailable drug concentration.
Use in ex vivo microfluidic sensor devices for rapid detection and quantification of drugs in patient fluid samples.
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