Georgetown University

Cambridge Medical Technologies LLC

Other

Science Applications International Corporation

Clinitech, LLC

Flexible Medical Systems, LLC

Leidos, Inc.

Touchtek Labs, LLC

Cuneiform Technologies, Inc.

John Frederick Currie

Makarand Paranjape

Joseph A Marcanio

Joseph J Vidalis

Robert Courtney White

Thomas Wayne Schneider

Carl C Peck

Helena Woodvine Snyder

Vikas Bhatia

Robert C White

Noureddine Melikechi

Sundar Nadarajan

Steven Michael Lacey

Gregory Pine

Emil F Jachmann

Howard Rosen

Abetif Essalik

Helena Woodvine

Abdel Essalik

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.

Methods of manufacture to optimize performance of transdermal sampling and analysis device

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.

Non-invasive transdermal sampling and analysis device incorporating redox cofactors

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.

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

A system and methods are provided for reducing electrochemical interference in a transdermal sampling and analysis device. A one-step transdermal glucose biosensor may calculate glucose concentrations that are artificially high compared to traditional home blood glucose sensors due to interference, which may be mitigated by forming an anti-interferent barrier layer over a sensing element. The anti-interferent barrier layer may be formed over a sensing layer and may possess a charge type which repels interferent molecules having the same charge type from interacting with the sensing layer disposed below the anti-interferent barrier layer.

Anti-interferent barrier layers for non-invasive transdermal sampling and analysis device

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.

Transdermal sampling and analysis device

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.

An apparatus, method, and computer readable medium for writing data on a highly indestructible material is disclosed. A laser may write data on a first side of a highly indestructible material. The data may then be marked as non-rewriteable. The data may also be written on a second side of the highly indestructible material, with the second side being opposite the first side. The highly indestructible material may comprise a stainless steel storage medium.

System and method for using stainless steel as a data archiving medium

The present invention pertains to a system and method for transdermal sampling, comprising: at least one sampler for retrieving and transferring at least one analyte obtained transdermally from the skin of a subject; at least one detector system for identifying and quantifying said at least one analyte; and at least one logic module for (i) receiving and storing input data from said at least one detector, (ii) relating the input data to other data obtained from the subject, (iii) displaying output information, (iv) transmitting the output information to another system, and (v) controlling the operation of said at least one sampler and at least one detector.

Systems and methods for monitoring health and delivering drugs transdermally

A system and method for transdermal sampling wherein at least one pair of sample electrodes is adapted to provide voltage pulses capable of creating capillary openings in a subject's stratum corneum. Methods for using a transdermal sampling system by creating capillary openings in a subject's stratum corneum via the application of a series of voltage pulses to the stratum corneum and contacting at least a portion of at least one of the sample electrodes with interstitial fluid from the capillary openings are also presented.

Appartus and method for continuous real-time trace biomolecular sampling, analysis, and delivery

The present invention generally relates to a system and method that co-locates in a small flexible, configurable system and multi-level substrate sampling, rapid analysis, bio-sample storage and delivery functions to be performed on living tissues or matter obtained from living organisms. The types of the sampling may include chemical, biochemical, biological, thermal, mechanical, electrical, magnetic and optical sampling. In general, the analysis performed at the point of sampling measures the sample taken and records its value. The bio-sample storage function encapsulates a small sample of analyte and preserves it for subsequent examination or analysis, either on the organism by the system or at a remote location by an independent analysis system. Once stored, the sample can provide a record of a biological state at the precise time of sampling. The delivery at the point of sampling can include chemical, biochemical, biological, thermal, mechanical, electrical, magnetic and optical stimuli.

Flexible apparatus and method for monitoring and delivery

The present invention is a gas component sensor comprising novel electrolyte compositions. The electrolyte compositions in bulk, sintered or thin film embodiments are capable of forming with different-metal sensing and reference electrodes a highly stable gas oxide sensors. The novel electrolyte composition changes electrochemical reactions at the sensing and reference electrodes and the overall reaction of the electrodes and electrolyte. The novel electrolyte compositions have: (1) excellent chemical stability and thermal compatibility as to the electrodes and a preferred ceramic substrate, (2) excellent chemical stability with the environment as to the reference and sensing electrodes, which need not be sealed against the atmosphere to be sensed, (3) effective adherence to the substrate and electrode metals.

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Bethesda, MD, United States of America

John Frederick Currie