Portable medical diagnosis instrument
Inventors
Straume, Tore • Loftus, David J. • Li, Jing • Davis, Cristina E. • Singh, Anup K. • Coleman, Matthew A.
Assignees
Lawrence Livermore National Security LLC • National Aeronautics and Space Administration NASA
Publication Number
US-9824870-B1
Publication Date
2017-11-21
Expiration Date
2035-04-29
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Abstract
A system that integrates several technologies into a single, portable medical diagnostic apparatus for analyzing a sample body fluid (liquid and/or gas): (1) a mechanism to capture airborne microdroplets and to separate the body fluid into a first fluid component (primarily gas) and a second fluid component (primarily liquid); (2) a volatilizer to convert a portion of the second fluid component into a third fluid component that is primarily a gas; (3) a functionalized nanostructure (NS) array configured to receive, identify, and estimate concentration of at least one constituent in the first and/or third fluid components; (4) a miniaturized differential mobility spectrometer (DMS) module; and (5) a biomarker sensor, to detect volatile and non-volatile molecules in a sample fluid, which may contain one or more components of blood, breath, perspiration, saliva, and urine.
Core Innovation
The invention integrates several technologies into a single portable medical diagnostic apparatus that analyzes a sample body fluid, including liquid and/or gas components. This integrated system comprises mechanisms to capture airborne microdroplets, to separate the body fluid into primarily gas and primarily liquid components, a volatilizer that converts a portion of the liquid component into a gas, a functionalized nanostructure array that identifies and estimates concentration of constituents in the gas components, a miniaturized differential mobility spectrometer module, and a biomarker sensor to detect volatile and non-volatile molecules in various body fluids such as blood, breath, perspiration, saliva, and urine.
The problem addressed is the need for improved and autonomous medical diagnosis technologies especially for extended human exploration missions where distance from Earth, mission duration, and environmental risks necessitate self-sufficient diagnostic capabilities. Existing medical screening cannot eliminate the risk of serious health conditions arising during long-duration missions, and unpredictable environmental hazards like radiation or bone loss further complicate diagnosis. Therefore, the invention aims to provide a medical system capable of diagnosing substantially all serious medical conditions that may arise during missions, with flexibility for modification to handle unforeseen conditions.
The invention achieves these needs by combining multiple instruments that analyze different body fluids from a test subject to estimate medical conditions. These include a condenser to receive body fluid, an array of functionalized nanostructures that measure electrical parameter changes to estimate specified components in the gas-phase fluid, an optional volatilizer converting liquid components into gases and vapors, a differential mobility spectrometer that discriminates ions based on mobility differences, and optional biomarker analyzers such as capillary action and centrifuge-assisted bead sedimentation analyzers. Each instrument offers a different physical or chemical perspective to provide comprehensive diagnostics.
Claims Coverage
The patent contains one independent claim that defines a method involving multiple analysis devices integrated in a compact analyzer and processing multiple body fluids.
Method using integrated plurality of analysis devices for body fluid analysis
Collecting a set of body fluids from a subject and inserting into a compact integrated analyzer comprising a nanostructure (NS) array, a differential mobility spectrometer (DMS), and a biomarker analyzer (BA) which is either a Centrifuge Assisted Bead Sedimentation Biomarker Analyzer (CASBA) or a Capillary Action Biomarker Analyzer (CABA), to analyze and display results.
Nanostructure (NS) array functionalization for chemical concentration estimation
Each NS array comprises at least one unfunctionalized NS and at least three functionalized NSs, each producing changes in discrete electrical parameter values (EPVs), permitting estimation of at least one concentration value of a first chemical in the sample.
Differential mobility spectrometer (DMS) ion discrimination
Each DMS is configured to distinguish between relative amounts of a first ion associated with a second chemical and a second ion associated with a third chemical by ionizing portions of the fluid sample processed through the DMS.
Biomarker analyzer (BA) for blood cell count and biomarker estimation
Each biomarker analyzer (either CASBA or CABA) is configured to determine blood cell counts and/or estimate amounts of biomarkers in the fluid sample processed through the BA.
Output of relative amounts, counts, concentrations and derived conditions
The set of results comprises relative amounts, counts, and/or concentrations determined by each analysis device and/or calculated values or medical conditions derived from those determined values.
The claim covers a method for analyzing body fluids by use of an integrated portable device combining nanostructured sensors, a differential mobility spectrometer, and biomarker analyzers configured for detecting chemical concentrations, ion species, and biomarkers, enabling comprehensive diagnostic output of fluid constituents and associated medical conditions.
Stated Advantages
Robust and long-lasting sensors with at least three years lifetime that operate under high intensity vibrations and variable environmental conditions.
Rapid and sensitive detection capability with low detection limits for multiple specified components (e.g., gases at parts per billion concentration).
Ability to estimate concentrations of single or multiple components using nonlinear models and calibrated coefficients for improved accuracy.
Integrated multi-instrument approach providing multiple independent perspectives on body fluid analysis for improved medical diagnosis.
Capability to autonomously adapt to unanticipated medical conditions through flexible instrumentation and analysis methods.
Rapid sample-to-answer procedure achievable within 15 minutes using miniaturized assay systems.
Documented Applications
Medical diagnosis during extended human space exploration missions (e.g., Mars missions) requiring autonomous and self-sufficient health monitoring.
Analysis of various body fluids including blood, breath, perspiration, saliva, and urine for detecting medical conditions.
Monitoring volatile and non-volatile molecules to detect biomedical markers associated with a wide range of medical conditions.
Screening for environmental hazards and health effects such as radiation exposure and bone loss induced by microgravity.
Rapid detection and quantification of biomarkers including blood cell counts and specific analytes using microfluidic and sedimentation-based immunoassays.
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