Transdermal sampling and analysis device
Inventors
Currie, John F. • Marcanio, Joseph A. • Vidalis, Joseph J.
Assignees
Cambridge Medical Technologies LLC
Publication Number
US-9451913-B2
Publication Date
2016-09-27
Expiration Date
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Abstract
Transdermal sampling and analysis device, method and system are provided for non-invasively and transdermally obtaining biological samples from a subject and determining levels of analytes of the obtained biological samples. The transdermal sampling and analysis device, method and system may cause disruption to the skin cells to create capillary-like channels from which biological samples may flow to the transdermal sampling and analysis device. The transdermal sampling and analysis device, method and system may collect the biological samples in a reservoir and transport the biological samples to a sensing chamber. The sensing chamber may contain at least two sensing electrodes coated with a biologically reactive element which reacts with the transported biological sample. The sensing chamber may be configured to mitigate the formation of air bubbles which may impede the transport and distribution of the biological sample across the entirety of the sensing chamber.
Core Innovation
Transdermal sampling and analysis device, method and system are provided for non-invasively and transdermally obtaining biological samples from a subject and determining levels of analytes of the obtained biological samples. The transdermal sampling and analysis device, method and system may cause disruption to the skin cells to create capillary-like channels from which biological samples may flow to the transdermal sampling and analysis device, collect the biological samples in a reservoir and transport the biological samples to a sensing chamber containing at least two sensing electrodes coated with a biologically reactive element which reacts with the transported biological sample. The sensing chamber may be configured to mitigate the formation of air bubbles which may impede the transport and distribution of the biological sample across the entirety of the sensing chamber.
The various embodiment methods and apparatus allow for a safe and non-invasive transdermal extraction of biological samples using a disruptor unit to generate a localized heat that alters the permeability of the stratum corneum without damaging the stratum corneum so that interstitial fluid may flow and be collected for analysis. The various embodiment methods and apparatus implement channel and reservoir configurations which assist in the delivery of the collected samples to biologically reactive elements for sensing of certain properties of the collected samples.
Claims Coverage
Independent claims identified: 1, 15, and 22. The following extracts the main inventive features recited in those independent claims.
Disruptor configured to generate a localized heat
At least one disruptor mounted on the first side of the substrate, wherein the at least one disruptor is configured to generate a localized heat capable of altering the permeability characteristics of a stratum corneum layer of skin of an organism, wherein the localized heat causes capillary-like channels between disrupted cells in the stratum corneum.
Substantially circular reservoir configured to collect biological sample
A reservoir configured to collect and contain a biological sample that is obtained through the capillary-like channels, wherein the reservoir is substantially circular.
Sensing chamber intersecting reservoir with tapered smooth surface and channel array
A sensing chamber connected to the reservoir, wherein an outer edge of the sensing chamber intersects the reservoir at an intersection point comprising a tapered smooth surface, and wherein the sensing chamber comprises a plurality of channel supports and a plurality of channels formed between the channel supports, wherein an aspect ratio of a height to a width of each of the plurality of channels is approximately 10:1.
Biological sensing element with at least two sensing electrodes
A biological sensing element comprising at least two sensing electrodes mounted on the first side of the substrate, wherein the biological sensing element is configured to determine the levels of an analyte in the biological sample, wherein the sensing chamber is configured to contain the biological sample around the at least two sensing electrodes.
Circular sensing chamber surrounding reservoir periphery
A circular sensing chamber surrounding a periphery of the reservoir, the sensing chamber comprising a plurality of channel supports and a plurality of channels formed between the channel supports, wherein an aspect ratio of a height to a width of each of the plurality of channels is approximately 3:1, and a biological sensing element comprising at least two sensing electrodes mounted on the first side of the substrate configured to determine levels of an analyte in the biological sample.
Sensing chamber intersecting reservoir at a sharp cornered surface
A sensing chamber connected to the reservoir, wherein an outer edge of the sensing chamber intersects the reservoir at an intersection point comprising a sharp cornered surface, and wherein the sensing chamber comprises a plurality of channel supports and a plurality of channels formed between the channel supports, wherein an aspect ratio of a height to a width of each of the plurality of channels is approximately 10:1, together with a biological sensing element comprising at least two sensing electrodes mounted on the first side of the substrate.
The independent claims center on three core device concepts: a disruptor that generates localized heat to create capillary-like channels in the stratum corneum; a substantially circular collection reservoir coupled to a sensing chamber; and sensing chambers with defined channel-support arrays (including tapered or circular configurations and specified channel aspect ratios) that contain biologically coated electrodes for analyte determination.
Stated Advantages
Provides safe and non-invasive transdermal extraction of biological samples.
Obtains and analyzes transdermally extracted biological samples with minimal injury or sensation to the subject.
Enables the entire process—disrupting skin cells, collecting biological samples, reacting with a biologically reactive element, and sensing—in a singular device, reducing contamination risk and time.
Permits accurate real-time analysis of very small amounts of biological samples, requiring a smaller biological sample volume.
Reduces risks associated with invasive sampling, such as pain, infection, and hemorrhage (as compared to conventional invasive tissue extraction techniques).
Documented Applications
Monitoring for viability and functionality of organs and tissues prepared and stored for surgical implantations.
Monitoring entire chemical panels for individuals, patients, or populations at risk.
Monitoring for critical care, shock, trauma and resuscitation.
Monitoring for chronic critical diseases.
Monitoring for early detection of diseases.
Monitoring for response to therapeutic treatments.
Use in gene therapy.
Analyzing biological samples already collected from food, water, air, whole blood, urine, saliva, chemical reactions or cultures.
Monitoring glucose levels for diabetics (glucose sensing described throughout the document).
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