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NASA NTRSDate not supplied

rHealth One Demonstration Aboard ISS: A Microfluidic Bioanalyzer Based on Sheath/Hydrodynamic Focusing Flow Cytometry

The Exploration Medical Capability (ExMC) element aims to provide astronauts with the means for their own health monitoring, diagnosis, and treatment during exploration missions. As space flight ventures further from earth, the need for autonomous medical care increases under greater constraints on size, mass, and resources. One pillar for diagnosis that crew would be separated from is laboratory analysis. Even now on ISS, blood samples must be collected and returned to earth for testing. In response, ExMC is assessing how assays for hematology, bone health, radiation exposure etc. could be addressed through commercial-off-the-shelf (COTS) and Small Business Innovation Research (SBIR) funded bioanalyzers that are miniaturizing lab technology. Since missions will reach distances where there are no timely replacements, validation on the International Space Station (ISS) is a necessary part of that assessment. In partnership with NASA Johnson Space Center (JSC) Immunology Lab and the Research Operations and Integration (ROI) element, ExMC conducted a technology demonstration on ISS of the rHEALTH ONE, a flow cytometry based bioanalyzer, to assess future devices based on this design. In flow cytometry, there are predominantly three ways to focus the cells (or particles) into a single file stream: hydrodynamic focusing, microcapillary, and acoustic focusing. The rHEALTH ONE utilizes the commercial standard, sheath-based hydrodynamic focusing. rHEALTH itself represents both a company and a suite of medical tools NASA has funded through SBIR grants towards the development of a promising diagnosis instrument for exploration missions. rHEALTH ONE is the interim version of the technology, functional as a benchtop analyzer and test bed for the next generation of rHEALTH in development. Several modifications were made to the rHEALTH ONE analyzer for operation in microgravity. For function, fluid management was key. A sheath-based analyzer uses sheath fluid to flow the sample, cleaning fluid to prevent biological contamination, and a reservoir to collect the liquid waste. The rHEALTH ONE analyzer uses bottles dependent on gravity to separate the air and liquid pathways and keep the liquids contained. It uses only 1 psig of air pressure to directly push the liquid through the device, requiring little-to-no resistance at inlet and outlet. A microtubing assembly with self-sealing luer connectors was designed – featuring 0.014 mm thick durable medical balloons to hold water inside the supply bottles – to create safe containment and easy access for the crew while maintaining the analyzer’s function. For safety, copper tape was added to the interior of the plastic housing to reduce electromagnetic interference, fluid and electrical connections were secured against vibration and leaks, and gaps were further sealed to ensure containment of the optical block and lasers. Water as the sheath and cleaning fluid and TOX 0 samples were used to reduce the biohazard risk to the crew. In May 2022, European Space Agency astronaut Samantha Cristoforetti demonstrated the rHEALTH ONE aboard ISS for its sample loading, flow cytometry, and data collection capability in microgravity. The JSC Immunology Lab provided flow cytometry expertise, designed the sample test protocol, and manufactured and benchmarked the flight samples on a ‘gold-standard’ flow cytometer. The analyzer was primed with water, purged of air, and four calibration solutions of polystyrene microparticles were tested to characterize its performance. Tightly controlled procedures and excellent execution prevented air bubble interference during air/water separation, fluid transfer, sample mixing and loading. Data showed a slight increase in signal noise on 3 of 5 channels and an anomaly of fluorophores migrating in one sample (confirmed by JSC post-flight). Flight results correctly detected the change in sample, matched the analyzer’s ground performance, and were consistent with the gold-standard’s ground results. Although areas were noted for improvement, these outcomes signified complete mission success.

R. S. Miller↗
NASA NTRS2015

The Reusable Handheld Electrolyte and Lab Technology for Humans (rHEALTH) Sensor

The DNA Medicine Institute has produced a reusable microfluidic device that performs rapid, low-cost cell counts and measurements of electrolytes, proteins, and other biomarkers. The rHEALTH sensor is compact and portable, and it employs cutting-edge fluorescence detection optics, innovative microfluidics, and nanostrip reagents to perform a suite of hematology, chemistry, and biomarker assays from a single drop of blood. A handful of current portable POC devices provide generalized blood analysis, but they perform only a few tests at a time. These devices also rely on disposable components and depend on diverse detection technologies to complete routine tests-all ill-suited for space travelers on extended missions. In contrast, the rHEALTH sensor integrates sample introduction, processing, and detection with a compact, resource-conscious, and efficient design. Developed to monitor astronaut health on the International Space Station and during long-term space flight, this microscale lab analysis tool also has terrestrial applications that include POC diagnostics conducted at a patient's bedside, in a doctor's office, and in a hospital.

Chan, Eugene↗
NASA NTRSDate not supplied

rHEALTH Laboratory Analyzer - ISS Increment 66 Tech Demo

A multilateral, web-based symposium, featuring ISS Increment 66 investigations will be held on December 14, 15 and 16, 2021 beginning at 0600 CST each day. The purpose of this event is for Principal Investigators to present their science objectives, testing approach, and measurement methods to agency scientists, managers, and other investigators. Participation is encouraged to gather a global picture of the science planned to be performed on ISS during Increment 66. Please note that only Increment 66 new investigations and those that have not been covered by previous science symposia will be included. We will be in touch with the investigations’ POCs to confirm the presentations and identify the speakers as we develop the preliminary agenda for the Symposium. The agenda and additional details will be distributed prior to the symposium. Presentations will be organized by discipline and will be allotted 15 minutes to highlight the main contributions of their experiment. There will be a short question and answer period after each discipline group session is complete. Please include back-up material as needed. The presentations may be made available to ISS crew members as review material for on-orbit science preparation and/or public outreach activities. Therefore, please ensure a comprehensive presentation (additional back-up material may be provided). The presentations should briefly cover the following: - Science background and hypothesis - Investigation goals and objectives - Measurement approach - Importance and reason for ISS - Expected results and how they will advance the field - Earth benefits/spin-off applications Please note that all presentations and discussions should be limited to content approved for export and information that can be shared with participants and the general public.

Laboratory Analysis↗
NASA NTRS2012

Handheld Universal Diagnostic Sensor

The rHEALTH technology is designed to shrink an entire hospital testing laboratory onto a handheld device. A physician or healthcare provider performs the test by collecting a fingerstick of blood from a patient. The tiny volume of blood is inserted into the rHEALTH device. Inside the device is a microfluidic chip that contains small channels about the width of a human hair. These channels help move the blood and analyze the blood sample. The rHEALTH sensor uses proprietary reagents called nanostrips, which are nanoscale test strips that enable the clinical assays. The readout is performed by laser-induced fluorescence. Overall, the time from blood collection through analysis is less than a minute.

Chan, Eugene↗
NASA NTRS2024

ISS Technology Demonstrations for Future Spaceflight Medical Systems

Throughout the history of human spaceflight, crewmembers have experienced various in-flight medical conditions including illness and injury. Planned missions to the Moon and Mars will require capabilities to maintain the health of future space travelers. Mass, power, and volume available in the vehicles and habitats for these missions will be severely constrained; resupply of resources will be limited or non-existent, as will opportunities for evacuation to Earth. Furthermore, ground-based support will be hampered by communication latencies and blackouts. These vehicle and mission constraints will necessitate a medical system that has been efficiently planned, providing on-board procedural guidance in addition to a variety of medical devices and consumable resources. Medical capabilities required for the diagnosis and treatment of potential medical conditions during future spaceflight missions may include real-time health monitoring, medical imaging, and biomarker analyses ( e.g., blood or urine). Terrestrial medicine shares these needs, thus many of these medical capabilities could likely be satisfied by Commercial-Off-The-Shelf (COTS) devices and methodologies; however, in some cases the unique space environment and increased mission duration will drive the need to modify technologies and the way care is provided. NASA’s Human Research Program (HRP) Exploration Medical Capability (ExMC) Element and Mars Campaign Office’s Exploration Medical Integrated Product Team (XMIPT) are working together to decrease medical risk during exploration missions. Flight-tested medical diagnostic and treatment technologies are necessary to effectively manage medical conditions relevant to exploration missions while meeting vehicle constraints, integrating with medical decision-support tools, and enabling increasingly Earth-independent operations. Several projects have leveraged the ISS as a testbed for exploration, including 1) i n- situ blood analysis, 2) medical inventory, 3) intravenous fluid generation, and 4) autonomous medical procedure guidance. Management of several in-flight medical conditions, such as bacterial and viral infections and acute radiation syndrome, is dramatically improved with ability to assess blood cell populations, electrolytes, and metabolites. I n December 2020 and January 2021 ExMC performed an ISS technology demonstration (Tech Demo) of the HemoCue® WBC DIFF analyzer (HemoCue, Brea, CA), a COTS device that was modified to enable functionality in a spaceflight environment. This Tech Demo marked the first time that hematology measurements were successfully performed real-time in microgravity. Also modified and demonstrated was the reusable Handheld Electrolytes and Lab Technology for Humans (rHEALTH) ONE analyzer (rHEALTH, Bedford, MA), which uses flow cytometry and sheath-based hydrodynamic focusing methodologies. The rHEALTH ONE ISS Tech Demo in May 2022 demonstrated test results obtained in-flight matched those on the ground. NASA currently relies on crew self-reporting to manage and maintain medical inventory on ISS.The ability to maintain an accurate inventory becomes more critical during long duration missions since the crew will need to be increasingly autonomous in finding and utilizing medical items, including those scenarios when alternative treatments need to be considered due to limited or no resupply. HRP’s Medical Consumables Tracking (MCT) project was developed by ZIN Technologies, Inc. (Cleveland, OH), and demonstrated real-time tracking of medical supplies aboard the ISS between December 2016 and July 2018. The MCT system design utilized Radio Frequency Identification Device (RFID) technology to perform automated inventory and was installed in the Crew Health Care System (CHeCS) Resupply Stowage Rack (RSR). The challenge of limited shelf life, exacerbated by the lack of resupply opportunities, affects a plethora of medical system components including consumables, pharmaceuticals, and intravenous (IV) fluid. In 2010, ExMC funded ZIN Technologies, Inc. (Cleveland, OH), to develop the Intravenous Fluid Generation (IVGEN) system. IV fluids were successfully generated with IVGEN using the potable water supply on ISS during ISS Expedition 23. The XMIPT is in the process of developing a miniaturized version of the original IVGEN hardware for a future Tech Demo aboard the ISS. Current ISS medical operations rely heavily on preflight training and real-time remote guidance, both of which become impractical or impossible for exploration missions. The primary goal of the Autonomous Medical Officer Support (AMOS) Software Tech Demos on ISS was to confirm telemedical proof-of-concept for autonomous medical imaging in an operational setting. This novel software tool shifts emphasis from preflight training and real-time remote guidance to in-flight just-in-time instruction, a new and necessary paradigm for crew medical autonomy. AMOS introduces a novel, streamlined skill management concept for exploration missions featuring comprehensive training and guidance modules for ultrasound examinations using the ISS Ultrasound 2 (a modified GE Vivid-q™; General Electric HealthCare, Chicago, IL). With no prior crew training or remote guidance, two Tech Demos on the ISS (April 2020 and June 2022) resulted in high quality, clinically useful image sets. We will provide a review of historical, current, and planned medical devices and technologies considered for inclusion within future spaceflight medical systems and summarize hardware development activities and medical device tech demos conducted on the ISS.

Astronaut health and performance↗
NASA NTRS2009

Microfluidic Mixing Technology for a Universal Health Sensor

A highly efficient means of microfluidic mixing has been created for use with the rHEALTH sensor an elliptical mixer and passive curvilinear mixing patterns. The rHEALTH sensor provides rapid, handheld, complete blood count, cell differential counts, electrolyte measurements, and other lab tests based on a reusable, flow-based microfluidic platform. These geometries allow for cleaning in a reusable manner, and also allow for complete mixing of fluid streams. The microfluidic mixing is performed by flowing two streams of fluid into an elliptical or curvilinear design that allows the combination of the flows into one channel. The mixing is accomplished by either chaotic advection around micro - fluidic loops. All components of the microfluidic chip are flow-through, meaning that cleaning solution can be introduced into the chip to flush out cells, plasma proteins, and dye. Tests were performed on multiple chip geometries to show that cleaning is efficient in any flowthrough design. The conclusion from these experiments is that the chip can indeed be flushed out with microliter volumes of solution and biological samples are cleaned readily from the chip with minimal effort. The technology can be applied in real-time health monitoring at patient s bedside or in a doctor s office, and real-time clinical intervention in acute situations. It also can be used for daily measurement of hematocrit for patients on anticoagulant drugs, or to detect acute myocardial damage outside a hospital.

Chan, Eugene Y.↗
NASA NTRS2016

Exploration Laboratory Analysis

The Exploration Laboratory Analysis (ELA) project supports the Exploration Medical Capability (ExMC) risk to minimize or reduce the risk of adverse health outcomes and decrements in performance due to in-flight medical capabilities on human exploration missions. To mitigate this risk, the availability of inflight laboratory analysis instrumentation has been identified as an essential capability for manned exploration missions. Since a single, compact space-ready laboratory analysis capability to perform all exploration clinical measurements is not commercially available, the ELA project objective is to demonstrate the feasibility of emerging operational and analytical capability as a biomedical diagnostics precursor to long duration manned exploration missions. The initial step towards ground and flight demonstrations in fiscal year (FY) 2015 was the downselection of platform technologies for demonstrations in the space environment. The technologies selected included two Small Business Innovation Research (SBIR) performers: DNA Medicine Institute's rHEALTH X and Intelligent Optical System's lateral flow assays combined with Holomic's smartphone analyzer. The selection of these technologies were based on their compact size, breadth of analytical capability and favorable ability to process fluids in a space environment, among several factors. These two technologies will be advanced to meet ground and flight demonstration success criteria and requirements. The technology demonstrations and metrics for success will be finalized in FY16. Also, the downselected performers will continue the technology development phase towards meeting prototype deliverables in either late 2016 or 2017.

In-Flight laboratory↗
NASA NTRS2016

Exploration Laboratory Analysis

The Exploration Laboratory Analysis (ELA) project supports the Exploration Medical Capability (ExMC) risk to minimize or reduce the risk of adverse health outcomes and decrements in performance due to in-flight medical capabilities on human exploration missions. To mitigate this risk, the availability of inflight laboratory analysis instrumentation has been identified as an essential capability for manned exploration missions. Since a single, compact space-ready laboratory analysis capability to perform all exploration clinical measurements is not commercially available, the ELA project objective is to demonstrate the feasibility of emerging operational and analytical capability as a biomedical diagnostics precursor to long duration manned exploration missions. The initial step towards ground and flight demonstrations in fiscal year (FY) 2015 was the down selection of platform technologies for demonstrations in the space environment. The technologies selected included two Small Business Innovation Research (SBIR) performers: DNA Medicine Institutes rHEALTH X and Intelligent Optical Systems later flow assays combined with Holomics smartphone analyzer. The selection of these technologies were based on their compact size, breadth of analytical capability and favorable ability to process fluids in a space environment, among several factors. These two technologies will be advanced to meet ground and flight demonstration success criteria and requirements that will be finalized in FY16. Also, the down selected performers will continue the technology development phase towards meeting prototype deliverables in either late 2016 or 2017.

Laboratory analysis↗
NASA NTRS2015

Nanoscale Test Strips for Multiplexed Blood Analysis

A critical component of the DNA Medicine Institute's Reusable Handheld Electrolyte and Lab Technology for Humans (rHEALTH) sensor are nanoscale test strips, or nanostrips, that enable multiplexed blood analysis. Nanostrips are conceptually similar to the standard urinalysis test strip, but the strips are shrunk down a billionfold to the microscale. Each nanostrip can have several sensor pads that fluoresce in response to different targets in a sample. The strips carry identification tags that permit differentiation of a specific panel from hundreds of other nanostrip panels during a single measurement session. In Phase I of the project, the company fabricated, tested, and demonstrated functional parathyroid hormone and vitamin D nanostrips for bone metabolism, and thrombin aptamer and immunoglobulin G antibody nanostrips. In Phase II, numerous nanostrips were developed to address key space flight-based medical needs: assessment of bone metabolism, immune response, cardiac status, liver metabolism, and lipid profiles. This unique approach holds genuine promise for space-based portable biodiagnostics and for point-of-care (POC) health monitoring and diagnostics here on Earth.

Chan, Eugene↗
NASA NTRS2024

Single Drop Cytometry Onboard the International Space Station

Real-time lab analysis is needed to support clinical decision making and research on human missions to the Moon and Mars. Powerful laboratory instruments, such as flow cytometers, are generally too cumbersome for spaceflight. Here, we show that scant test samples can be measured in microgravity, by a trained astronaut, using a miniature cytometry-based analyzer, the rHEALTH ONE, modified specifically for spaceflight. The base device addresses critical spaceflight requirements including minimal resource utilization and alignment-free optics for surviving rocket launch. To fully enable reduced gravity operation onboard the space station, we incorporated bubble-free fluidics, electromagnetic shielding, and gravity-independent sample introduction. We show microvolume flow cytometry from 10 μL sample drops, with data from five simultaneous channels using 10 μs bin intervals during each sample run, yielding an average of 72 million raw data points in approximately 2 minutes. We demonstrate the device measures each test sample repeatably, including correct identification of a sample that degraded in transit to the International Space Station. This approach can be utilized to further our understanding of spaceflight biology and provide immediate, actionable diagnostic information for management of astronaut health without the need for Earth-dependent analysis.

Daniel J. Rea↗