Non-invasive transdermal sampling and analysis device incorporating an electrochemical bioassay

Inventors

Snyder, Helena Woodvine • Bhatia, Vikas • Currie, John Frederick • Jachmann, Emil F.

Assignees

Cambridge Medical Technologies LLC

Abstract

Systems and methods are provided for determining levels of a target analyte in a biological sample. A transdermal sampling and analysis device may include a substrate, at least one disruptor mounted on the substrate, a reservoir configured to collect and contain a biological sample, at least two electrodes, and an electrochemical bioassay configured to determine levels of a target analyte in the biological sample. The at least one disruptor of the transdermal sampling and analysis device may be configured to generate a localized heat capable of altering permeability characteristics of a stratum corneum layer of skin of an organism.

Core Innovation

Embodiment transdermal sampling and analysis devices may include a substrate, at least one disruptor mounted on the substrate in which the at least one disruptor is configured to generate a localized heat capable of altering permeability characteristics of a stratum corneum layer of skin of an organism, a reservoir configured to collect and contain a biological sample, at least two electrodes, and an electrochemical bioassay configured to determine levels of a target analyte in the biological sample. The electrochemical bioassay may include a first small molecule binding element bound to a surface of at least one of the electrodes, at least one barrier layer covering a remainder of the surface such that the entire surface is either occupied by a bound first small molecule binding element or covered by the barrier layer, and a second small molecule binding element linked to an enzyme, wherein the second small molecule binding element, the linked enzyme, and at least one substrate of the linked enzyme are suspended in a hydrogel on top of the at least one of the electrodes. The summary expressly lists target analytes including cardiac troponin I (cTnI), melatonin, procalcitonin (PCT), heparin-binding protein (HBP), and interleukin-6 (IL-6).

The background identifies that conventional ELISA techniques must be performed through a series soak and wash steps where each component is introduced separately and are generally incompatible with real-time sampling and analysis. The background further states that biosensors using blood droplets are typically painful and inconvenient and require relatively large blood samples, and that conventional biosensors require several steps that are time consuming and may cause contamination or loss of the biological sample. The disclosure describes a one-step transdermal biosensor that enables in situ measurement by disrupting the stratum corneum to collect interstitial fluid and performing an electrochemical bioassay in the device to reduce sample size, reduce potential for contamination, and reduce time required for analysis.

Claims Coverage

There are two independent claims: one device claim and one method claim. The inventive features below extract the principal elements recited in those independent claims.

The independent device and method claims recite a transdermal sampling and analysis system that combines a substrate-mounted localized heat disruptor, a reservoir for collecting a biological sample (notably interstitial fluid), electrodes, and an electrochemical bioassay in which a first small molecule binding element and an alginate-containing barrier layer occupy the electrode surface while a second small molecule binding element linked to an enzyme with its substrate (and optionally a mediator) are suspended in a hydrogel above the electrode, and the method claim recites providing localized heat, collecting the sample, and determining analyte levels with that bioassay.

Stated Advantages

Documented Applications