Systems and methods for analyte detection
Inventors
YOSHIKAWA, Alexander • Sabnis, Vijit • Kapur, Pawan • KESLER, Vladimir • Ice, Donald A. • Mihalakis, George M.
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Assignees
Member
Adaptyx BiosciencesAdaptyx Biosciences is developing a wearable platform for continuous monitoring of multiple biomarkers in dermal interstitial fluid from a single device at the point of need. Built on programmable molecular switch technology that can be reprogrammed across hormones, drugs, electrolytes, peptides, and proteins, it is a single platform adaptable to needs spanning Military Operational Medicine, Combat Casualty Care, Military Infectious Diseases, Clinical and Rehabilitative Medicine, and Chemical, Biological, and Radiological Defense. The platform draws on more than 17 years of pioneering research from our team at Stanford. We have prototype sensors ready for R&D today, and have already demonstrated continuous measurement of multiple biomarkers in humans, including multi-day free cortisol monitoring that captures the diurnal rhythm conventional single-timepoint tests cannot see.
Adaptyx Biosciences is developing a wearable platform for continuous monitoring of multiple biomarkers in dermal interstitial fluid from a single device at the point of need. Built on programmable molecular switch technology that can be reprogrammed across hormones, drugs, electrolytes, peptides, and proteins, it is a single platform adaptable to needs spanning Military Operational Medicine, Combat Casualty Care, Military Infectious Diseases, Clinical and Rehabilitative Medicine, and Chemical, Biological, and Radiological Defense. The platform draws on more than 17 years of pioneering research from our team at Stanford. We have prototype sensors ready for R&D today, and have already demonstrated continuous measurement of multiple biomarkers in humans, including multi-day free cortisol monitoring that captures the diurnal rhythm conventional single-timepoint tests cannot see.
Publication Number
US-12109019-B2
Publication Date
2024-10-08
Expiration Date
Abstract
The present disclosure provides systems and methods to monitor analytes present in a biological sample of a subject using a piercing element coupled to a support configured to pierce a body surface of the subject, an analyte binding probe on or within the piercing to provide a change in an optical signal when contacting an analyte in the biological sample of the subject, and a detector configured to detect the optical signal.
Core Innovation
The invention relates to a device for sensing an analyte in a biological sample of a subject using a piercing element that pierces a body surface to bring an analyte binding probe into contact with the biological sample. The analyte binding probe is on or within the piercing element and provides a change in an optical signal when the analyte binding probe contacts the analyte.
The device includes a support, a light source, and a detector operatively coupled to the support to detect the optical signal. A waveguide includes an optical excitation path and an optical emission path, where the optical excitation path transmits light from the light source to the analyte binding probe and the optical emission path transmits light from the analyte binding probe toward the detector through apertures in a reflective cladding layer surrounding the waveguide.
The analyte binding probe can be embedded in a hydrogel matrix with one or more particles comprising the probe, and the probe can include a fluorophore-conjugated aptamer that changes conformation upon analyte binding to shift the optical signal. Additional refinements include optical emission path rejection based on a critical-angle range and optical conditioning that improves detector signal-to-noise ratio.
Claims Coverage
The claim coverage centers on an optical sensing device that combines a piercing-element analyte binding probe with a waveguide that manages excitation and emission light, including apertures in a reflective cladding layer. The inventive features include the piercing-element sensing architecture, the waveguide excitation and emission paths, hydrogel embedding, fluorophore-conjugated aptamer configurations, critical-angle rejection, and optical conditioning for detector signal-to-noise ratio.
Piercing-element analyte sensing device with optical probe readout
A support and a piercing element coupled to the support, wherein the piercing element is configured to pierce a body surface to bring the piercing element in contact with the biological sample; an analyte binding probe on or within the piercing element configured to provide a change in an optical signal when the analyte binding probe comes in contact with the analyte in the biological sample; a light source operatively coupled to the support; and a detector operatively coupled to the support configured to detect the optical signal.
Waveguide with excitation and emission paths and aperture-bearing reflective cladding
A waveguide comprising an optical excitation path and an optical emission path configured to transmit light from the light source to the analyte binding probe through the optical excitation path, and configured to transmit light through the optical emission path from the analyte binding probe towards the detector, wherein the optical emission path further comprises apertures in a reflective cladding layer surrounding the waveguide configured to transmit an emission light from the analyte binding probe to the detector.
Hydrogel sensing domain embedding particles comprising the probe
The analyte binding probe is located in a sensing domain and is embedded in a hydrogel matrix that contains one or more particles comprising the probe.
Fluorophore-conjugated aptamer that shifts optical signal via conformation change
An analyte-binding probe includes a fluorophore-conjugated aptamer that binds the analyte and changes conformation to cause an optical signal shift when the analyte is contacted.
Critical-angle rejection of emission light entering the waveguide
The optical emission path rejects emission light entering the waveguide at angles not within a critical-angle range of ±20 degrees from a normal to a base of the piercing element.
Optical conditioning to improve detector signal-to-noise ratio
Optical conditioning that can improve detector signal-to-noise ratio.
Overall, the claims cover a piercing-element optical sensing device with a waveguide that transmits excitation and emission light, apertures in a reflective cladding layer, and probe configurations including hydrogel embedding and fluorophore-conjugated aptamers. The additional claim language includes critical-angle rejection and optical conditioning to improve detector signal-to-noise ratio.
Stated Advantages
Improves detector signal-to-noise ratio.
Optical conditioning that can improve detector signal-to-noise ratio.
Documented Applications
Sensing an analyte in a biological sample of a subject.
Analytes present in biological fluids, including glucose, cortisol, electrolytes, metabolites, nucleic acids, proteins and biomarkers, lipoproteins, and drugs or contrast agents.
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