Non-invasive transdermal sampling and analysis device incorporating redox cofactors
Inventors
Snyder, Helena Woodvine • Bhatia, Vikas • Currie, John Frederick • Jachmann, Emil F.
Assignees
Cambridge Medical Technologies LLC
Publication Number
US-11633129-B2
Publication Date
2023-04-25
Expiration Date
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Abstract
Systems and methods are provided for determining levels of an analyte in a biological fluid 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 fluid sample; a sensing element comprising at least two sensing electrodes, and at least one layer of a cofactor covering the sensing element in which the cofactor catalyzes a reaction to determine levels of an analyte in the biological fluid sample. The at least one disruptor of the transdermal sampling and analysis device may generate a localized heat capable of altering permeability characteristics of a stratum corneum layer of skin of an organism. The surface of at least one of the sensing electrodes of the transdermal sampling and analysis device may be coated with a sensing layer in which an enzyme immobilized within a hydrogel.
Core Innovation
Embodiment transdermal sampling and analysis devices may include a substrate, at least one disruptor mounted on the substrate, a reservoir configured to collect and contain a biological fluid sample, a sensing element comprising at least two sensing electrodes, and at least one layer of a cofactor covering the sensing element. In some embodiment transdermal sampling and analysis devices, the at least one disruptor may be configured to generate a localized heat capable of altering permeability characteristics of a stratum corneum layer of skin of an organism. In some embodiment transdermal sampling and analysis devices, the surface of at least one of the sensing electrodes may be coated with a sensing layer comprising an enzyme immobilized within a hydrogel, and the cofactor may catalyze a reaction to determine levels of an analyte in the biological fluid sample.
The background describes problems with conventional biosensors, including that they require painful and invasive procedures, require a relatively large fluid sample, and require multiple steps before analysis, which is time consuming and may cause contamination or loss of the biological sample during collection and/or delivery. There is a stated need to develop biosensors that exhibit high sensitivity and low detection limits and to enable in situ measurement from small quantities of interstitial fluid to reduce sample volume, reduce contamination risk, and shorten the time required to obtain and analyze a sample.
Claims Coverage
This coverage addresses inventive features from two independent claims and ten extracted inventive features in total, corresponding to a device claim and a method claim.
Substrate
a substrate;
Disruptor generating localized heat
at least one disruptor mounted on the substrate, wherein 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;
Reservoir for biological fluid
a reservoir configured to collect and contain a biological fluid sample;
Sensing element with enzyme immobilized within hydrogel
a sensing element comprising at least two sensing electrodes, wherein a surface of at least one of the sensing electrodes is coated with a sensing layer comprising an enzyme immobilized within a hydrogel;
Non-bound cofactor layer that becomes free-floating and catalyzes reaction
at least one non-bound layer of a cofactor covering the sensing layer, wherein: the cofactor is configured to become free-floating upon introduction of the biological fluid sample to the sensing element; and the cofactor catalyzes a reaction to determine levels of an analyte in the biological fluid sample.
Method: providing a disruptor configured to generate localized heat
providing at least one disruptor mounted on a substrate, wherein 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;
Method: providing a reservoir
providing a reservoir configured to collect and contain the biological fluid sample;
Method: providing a sensing element with immobilized enzyme
providing a sensing element, comprising: at least two sensing electrodes, wherein a surface of at least one of the sensing electrodes is coated with a sensing layer comprising an enzyme immobilized within a hydrogel;
Method: applying a non-bound cofactor layer atop sensing layer
applying at least one non-bound layer of a cofactor atop the sensing layer, wherein the cofactor is configured to become free-floating upon introduction of the biological fluid sample to the sensing element and catalyzes a reaction to determine levels of an analyte in the biological fluid sample;
Method: providing the biological fluid to the sensing element and cofactor
providing the biological fluid sample to the sensing element and the at least one non-bound layer of the cofactor.
The independent device and method claims center on a transdermal sampling and analysis system combining a substrate-mounted heat-generating disruptor, a reservoir for collected biological fluid, a sensing element with an enzyme immobilized within a hydrogel on sensing electrodes, and at least one non-bound cofactor layer that becomes free-floating upon sample introduction to catalyze analyte-determining reactions.
Stated Advantages
Simplicity, portability, rapid response, high specificity, and simple operation.
High sensitivity and low detection limits for detecting small quantities of target analyte in small volumes.
Utilization of smaller biological sample volumes through in situ sampling from interstitial fluid.
Reduced potential for contamination or loss of the biological sample and reduced time required to obtain and analyze a sample.
Effective alternative to competing technologies for analyzing alcohol with strong correlation to blood alcohol concentration.
Documented Applications
Determining levels of an analyte in a biological fluid sample via a transdermal sampling and analysis device.
Alcohol (ethanol) detection using an alcohol dehydrogenase-based transdermal biosensor and comparison to blood alcohol concentration and breathalyzer results.
Lactate analysis using a lactate dehydrogenase-based transdermal biosensor for measuring lactate concentrations.
Glucose monitoring as an analyte detectable by enzyme-based amperometric biosensors.
Patient home monitoring of analytes using biosensors that measure electric current produced by enzyme-catalyzed redox reactions.
Detection of particular antibodies in a biological fluid sample using electrochemical impedance analysis techniques incorporated into the transdermal sampling and analysis device.
Continuous glucose and lactate assays for casualty and combat readiness assessment as referenced in incorporated publications.
Monitoring small molecule concentrations using amperometric biosensors that measure electrical current generated by enzyme-catalyzed reactions.
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