Transdermal sampling and analysis device
Inventors
Currie, John F. • Marcanio, Joseph A. • Vidalis, Joseph J. • Nadarajan, Sundar B.
Assignees
Cambridge Medical Technologies LLC
Publication Number
US-9877673-B2
Publication Date
2018-01-30
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 where the biological sample may chemically react with a biologically reactive element. A sensor may convert the produced electrons (ions) into measured electrical signals. The converted signals may be measured and the levels of an analyte may be determined based on the measured signals.
Core Innovation
Conventional methods for obtaining biological samples are invasive, uncomfortable, and painful and require breaching the skin, collecting biological samples, and delivering the obtained samples to an analyzing device. The patent states that these invasive procedures expose patients to pain, infection, bleeding, and require relatively large sample volumes which are undesirable. Based on the available documentation, information is insufficient.
The invention provides a transdermal sampling and analysis device, method and system for non-invasively and transdermally obtaining biological samples and determining levels of analytes of the obtained biological samples. The device uses a disruptor to generate a localized heat that alters the permeability of the stratum corneum without damaging the stratum corneum so that interstitial fluid flows through capillary-like channels into a reservoir where it may chemically react with a biologically reactive element and be sensed electrochemically.
The invention further provides channel and reservoir configurations and sensing elements on a substrate, and an applicator unit that can supply voltage to the disruptor, display sensed property values, and load disposable transdermal sampling and analysis device units. The integrated package allows disrupting the skin cells, collecting biological samples, reacting the samples with a biologically reactive element, and sensing the signals in a singular device to reduce sample volume, reduce contamination risk, and reduce time to obtain and analyze samples.
Claims Coverage
Independent claims: claim 1 and claim 58. The following inventive features (8) are extracted from the independent claims of the patent.
Disruptor mounted on substrate
A disruptor mounted on the first side of the substrate configured to generate a localized heat capable of altering the permeability characteristics of barrier cells to become permeable when a voltage is applied; the disruptor is recited with a specified resistance range [procedural detail omitted for safety]. (from claim 1)
Reservoir with collection portion and sensing chamber
A reservoir on the first side comprising a collection portion configured to collect and contain a biological sample obtained through the permeable barrier cells and a sensing chamber configured with a plurality of channels formed between a plurality of channel supports. (from claim 1)
Biological sensing element with sensing electrodes
A biological sensing element comprising at least two sensing electrodes mounted on the first side of the substrate, the biological sensing element being configured to determine levels of an analyte in the biological sample. (from claim 1)
Lid enclosing reservoir and electrodes
A lid configured to enclose the reservoir and the at least two sensing electrodes within a volume formed in the reservoir, together with a spacer disposed on top of the substrate. (from claim 1)
Hydrophilic lid adhesive layer
A lid adhesive layer adhering the lid to the spacer, wherein the lid adhesive layer is recited to have a hydrophilic wetting angle below a specified value [procedural detail omitted for safety]. (from claim 1)
Sensing chamber sample routing by channels
A sensing chamber configured to contain the biological sample around the at least two sensing electrodes, wherein the biological sample is directed over the surface of the at least two sensing electrodes by the plurality of channels. (from claim 1)
System including applicator device
A system comprising the transdermal sampling and analysis device and an applicator device comprising a housing to engage the device, a processor coupled to the sensing electrodes when engaged, a display, a memory, and a voltage source coupled to the processor. (from claim 58)
Processor-modified voltage application and sensing
The processor is configured to modify the voltage signal provided by the voltage source and apply the modified voltage signal to the disruptor, and the processor is configured to receive electrical signals from the at least two sensing electrodes and determine levels of analyte present in the biological sample. (from claim 58)
The independent claims recite a transdermal sampling and analysis device with a substrate-mounted disruptor, a reservoir with collection and sensing portions including channel supports, at least two sensing electrodes, a lid with hydrophilic adhesive and spacer, and a system including an applicator whose processor modifies and applies voltage to the disruptor and receives sensing signals.
Stated Advantages
Provides a safe and non-invasive transdermal extraction of biological samples.
Obtains and analyzes transdermally extracted biological samples with minimal injury or sensation.
Allows obtaining biological samples and delivering the samples to a biological sensor in a single step, minimizing potential risk of contamination.
Enables accurate real-time analysis of very small amounts of biological samples, reducing required sample volume.
Reduces the time required to obtain a sample and perform an analysis.
Applicator and disposable device units enable convenient replacement and potential remote analysis and monitoring.
Documented Applications
Monitoring glucose levels for diabetics and detecting analyte levels such as glucose.
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 and early detection of diseases.
Monitoring for response to therapeutic treatments and gene therapy.
Analyzing biological samples already collected from food, water, air, whole blood, urine, saliva, chemical reactions or cultures.
Delivering substances transdermally into capillary-like channels created by the disruptor.
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