Methods of manufacture to optimize performance of transdermal sampling and analysis device
Inventors
Vidalis, Joseph J • Marcanio, Joseph A • Currie, John Frederick • Snyder, Helena Woodvine • Bhatia, Vikas
Assignees
Cambridge Medical Technologies LLC
Publication Number
US-10898116-B2
Publication Date
2021-01-26
Expiration Date
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Abstract
Methods and systems for manufacturing a transdermal sampling and analysis device for non-invasively and transdermally obtaining biological samples from a subject and determining levels of analytes of the obtained biological samples are provided. A method of manufacturing the device may improve performance and includes forming channel structures on the lid of the device, thereby making the spacer/channel support structures physically independent and separable from the sensing electrode. Other methods of manufacturing the device may improve performance and include forming at least one of the electrodes on each of the base and the lid, and forming a recessed second spacer layer over the channel support structures, thereby separating the channel support structures and the electrode on the lid to allow a larger area of the electrode to be exposed to the biological sample.
Core Innovation
The invention provides methods and systems for manufacturing a transdermal sampling and analysis device for non-invasively and transdermally obtaining biological samples from a subject and determining levels of analytes of the obtained biological samples. The manufacturing methods include forming channel structures on the lid of the device to make the spacer/channel support structures physically independent and separable from the sensing electrode, forming at least one of the electrodes on each of the base and the lid, and forming a recessed second spacer layer over the channel support structures to separate the channel support structures and the electrode on the lid and thereby allow a larger area of the electrode to be exposed to the biological sample.
The background problem being solved is that conventional methods for obtaining biological samples are invasive, painful, multi-step, and require relatively large sample volumes, which can cause discomfort, increased risk of infection or bleeding, contamination during collection and delivery, and longer time to obtain analyte measurements. The invention addresses these problems by producing a transdermal sampling and analysis device with increased accuracy of sensing through improved manufacturing processes that yield a more uniform analyte sensing layer and reservoir/channel configurations that prevent the analyte sensing reagent from blocking flow through channels, enabling non-invasive, single-step collection and in-situ analysis of small biological samples.
Claims Coverage
This section identifies inventive features extracted from the single independent claim presented in the patent (one independent claim).
Substrate having a first side
A substrate having a first side on which device components are mounted.
Disruptor configured to generate localized heat
At least one disruptor mounted on the first side of the substrate, configured to generate a localized heat capable of altering permeability characteristics of barrier cells to become permeable when a voltage is applied across the disruptor.
Reservoir with circular collection portion
A reservoir on the first side of the substrate comprising a circular collection portion configured to collect a biological sample obtained through permeable barrier cells, the circular collection portion substantially parallel to a plane of the skin.
Sensing chamber concentric with the collection portion
A sensing chamber portion configured to receive the biological sample from the circular collection portion, wherein the sensing chamber surrounds a periphery of the circular collection portion such that the sensing chamber is concentric with the circular collection portion and substantially parallel to the plane of the skin.
Lid structure configured to enclose the reservoir
A lid structure configured to enclose the reservoir.
Biological sensing element with at least two electrodes
A biological sensing element comprising at least a first electrode and at least a second electrode, configured to determine a level of an analyte in the biological sample.
First and second spacer layers
A first spacer layer disposed on the first side of the substrate and a second spacer layer disposed over the first spacer layer, wherein the sensing chamber portion is configured to contain the biological sample between the at least first and at least second electrodes.
The independent claim defines a transdermal sampling and analysis device combining a substrate-mounted disruptor that produces localized permeability, a concentric circular reservoir and surrounding sensing chamber, a lid to enclose the reservoir, a biological sensing element with at least two electrodes, and a stacked spacer arrangement (first and second spacer layers) that together enable collection and sensing of a biological sample between electrodes.
Stated Advantages
Increased accuracy of glucose sensing resulting from manufacturing processes that produce a more uniform analyte sensing reagent layer.
Reservoir and channel configurations that prevent the analyte sensing reagent from blocking flow through channels, preserving sample movement to sensors.
Separation of channel support structures from sensing electrode (e.g., by forming channel structures on the lid and recessed spacer) to allow a larger area of an electrode to be exposed to the biological sample.
Safe, non-invasive transdermal sampling with minimal injury or sensation compared to invasive tissue extraction techniques.
Single-step obtaining and in-situ analysis of biological samples to minimize contamination and reduce time between sample collection and analysis.
Accurate real-time analysis from very small quantities of interstitial fluid, reducing required sample volume.
Documented Applications
Non-invasive glucose monitoring (transdermal glucose biosensor) for determining glucose concentration from interstitial fluid.
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, early detection of diseases, and monitoring response to therapeutic treatments.
Gene therapy (monitoring context explicitly described).
Analyzing biological samples already collected from food, water, air, whole blood, urine, saliva, chemical reactions or cultures.
Delivery of substances transdermally into capillary-like channels of the skin (device used to deliver substances).
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