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Blood, Sweat and Tears Workshop
Medical Capabilities for Exploration
Spaceflight
Michael Krihak, PhD1 and Ronak Shah, DO, MBA, MPH2
1University of California Santa Cruz, NASA Ames Research Center, Moffett Field, CA2University of Texas Medical Branch, NASA Johnson Space Center, Houston, TX
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19 August 2015
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Overview
• Exploration Medical Capability (ExMC)
• Vital Signs Monitoring
• Laboratory Analysis
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Human Research Program
Behavioral Health &
Performance
Human Health & Countermeasures
Space Human Factors
Habitability
Space Radiation
Exploration Medical
Capability
ISS Medical Project
• Program goals
– Improve human health and performance
– Develop medical and human performance standards
– Identify and validate technologies that reduce risks
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Medical Risk
Risk of Adverse Health Outcomes & Decrements in
Performance due to Inflight Medical Conditions.
Given that medical conditions will occur during
human spaceflight missions, there is a possibility of
adverse health outcomes and decrements in
performance during these missions and for long
term health.
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Exploration Medical Care
Level of Care Mission Capability
I LEO < 8 days
Space Motion Sickness, Basic Life Support, FirstAid, Private Audio, Anaphylaxis Response
II LEO < 30 days
Level I + Clinical Diagnostics, Ambulatory Care,Private Video, Private Telemedicine
III Beyond LEO < 30
days
Level II + Limited Advanced Life Support, TraumaCare, Limited Dental Care
IV Lunar > 30 days
Level III + Medical Imaging, SustainableAdvanced Life Support, Limited Surgical, Dental Care
V Mars Expedition
Level IV Autonomous Advanced Life Support andAmbulatory Care, Basic Surgical Care
TABLE 3.5.5.3.5-1 MEDICAL CARE CAPABILITIES
LEO – Low-Earth OrbitRef: NASA CxP 70024 – Constellation Program Human-Systems Integration Requirements (Revision B), March 3, 2008.Ref: NASA-STD-3001, Volume 1, NASA SPACE FLIGHT HUMAN SYSTEM STANDARD VOLUME 1: CREW HEALTH, Approved: 03-05-2007.
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Exploration Missions: - Limited (if any) resupply
- Delayed or absent communications
- Harsh environment
- Limited mass, volume, power
- Limited resources
- Isolation
- Do not increase the complexity of
the system more than you have to
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If we also have to bring this, we are doing it wrong.
We will already have this:
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Areas of Interest
Areas of focus
• Biosensors
• Lab Analysis
• Imaging
• Medical Training
• Clinical Decision
Support
• Integrated Medical
Systems
Source: NASA, Retrieved from: http://www.wired.com/wiredscience/2012/08/is-a-privately-funded-manned-mission-to-mars-possible/
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Biosensors
• Non-invasive
• Wireless
• Integrated sensor suites
• Minimal skin
preparation
• Easy to don/doff
• Robust hardware
• Integration with vehicle
subsystems
Source: http://www.connectedhealthworld.com/products/218
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Lab Analysis
• Point-of-care
• Handheld
• Minimal sample prep
• Reagent shelf life > 3 yrs
• Minimal consumables
• Reusable components
• Integration with vehicle
subsystems
Source: https://technology.grc.nasa.gov/SS-rHealth.shtm
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Medical Risk & ExMC Gap
Risk of Adverse Health Outcomes & Decrements in
Performance due to Inflight Medical Conditions.
Derived ExMC Gap 4.19:
We do not have the capability to monitor physiological
parameters in a minimally invasive manner during
exploration missions.
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VITAL SIGNS MONITORINGMedical Capabilities for Exploration Spaceflight
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Background
• Applications of vital signs monitoring during space flight include:
– Planned health evaluations and pre-EVA check-outs
– Nominal exercise and periodic aerobic fitness tests
– Exercise countermeasures activities
– Evaluation of an ill or injured crewmember
– During contingency return scenarios
• Current monitoring drawbacks for exploration– The current system for donning biomedical sensors is time consuming and inconvenient
(skin preparation, application of electrodes, and signal checks)
– Mass, volume and system integration
• Ideal solution:– A more efficient system, achieved through the integration of small, easy-to-use
biomedical sensors, will save crew time and reduce the overhead of stowing additional supplies.
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Device Considerations
• Accuracy
• Requires low amount of consumables
• Non-invasive
• Compact, low mass
• Multifunctional (includes all key parameters)
• Mobile, wireless
• Donned and operated by single user
• Measure, store and transmit data
• Fully interoperable with an integrated medical data
management system
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Key Parameters of Interest
• Electrocardiogram
• Heart Rate
• Blood Pressure
• Pulse Oximetry
• Respiration Rate
• Body Temperature
• Cardiac Output
• Accelerometry (activity)
Note : Parameters currently measured on ISS with four separate devices
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Technology Status - ECG
ECG parameter - purpose/focus
• Monitor cardiac health and activity of crewmembers
ECG background – concerns, challenges
• Principal technical challenge is in establishing stable electrical
contact with the skin
• Resistive contact electrodes are the most widely used and
traditionally are gel-containing ‘paste-on’ (or wet) electrodes
which can cause
• issues with skin preparation
• irritation with long term wear
• Traditional wet electrode signals are subject to noise,
corruption, and loss
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Technology Status – ECG (continued)
Current ISS means of measurement
• Traditional wet gel ECG electrodes have been and continue to be used in space flight
• The current method of measuring ECG data on the ISS is via the BP/ECG Kit
• 5-lead electrode system
• RS-232 communication with the Medical Equipment Computer (MEC)
• Ops LAN for file transfer to the ground
Pros / Cons
• Pros: Includes capabilities to measure ECG, HR, and blood pressure
• Con: Uses traditional wet electrodes
• Con: Requires resupply kits
• Con: The BP/ECG and resupply kits are bulky and heavy according to modern
standards and do not fit the constraints envisioned for exploration-class mission
hardware.
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ECG Solution
ECG / Dry Electrode Project goals are the following:
• Certify a single ECG system that can perform both 12 lead diagnostic and 2 lead monitoring measurements
• Identify dry electrode technology to replace traditional wet electrodes
Space Station Hardware
Exploration Needs:
• 12-lead ECG diagnostic system
• Maximize the comfort, ease of use, reliability, and accuracy
• Minimize the equipment's mass, volume, power, and time for set-up and use
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EXPLORATION LABORATORY ANALYSIS (ELA)
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Medical Risk & ExMC Gap
Risk of Adverse Health Outcomes & Decrements in
Performance due to Inflight Medical Conditions.
Derived ExMC Gap 4.05:
We do not have the capability to measure laboratory
analytes in a minimally invasive manner during
exploration missions
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Technology Status - Current Spaceflight Capability
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• International Space Station (ISS) medical diagnostics capability
maintains very limited capability for in-flight analysis of bodily fluids
(urine, blood, saliva).
• Upmass availability for re-supply
• Two diagnostic instruments are onboard the ISS
– Portable Clinical Blood Analyzer (PCBA) or i-STAT (Abbott) provided by United
States
– Reflotron (Roche) provided by Russians
• Though some in-situ diagnostic capability demonstrated, several
drawbacks for space exploration persist
– Refrigerated disposables; limited shelf-life
– Unable to provide blood cell analysis
– Waste/consumables ISS i-STAT PCBARef:
http://www.nasa.gov/mission_pages/station/research/experiments/373.html#images
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Point-of-Care (POC) Devices
• Over the past decade, POC devices have emerged for:
– Bedside care; doctor’s office
– Care in remote locations (e.g. 3rd World, developing nations)
– Military operations in forward combat locations
• POC technologies are generally compact instruments
– However, often limited in the breadth of measurements
– Typically offer a subset of the ExMC operational analyte
• Clinically validated, commercial-off-the-shelf (COTS) instruments
are emerging that can provide all measurements.
– Mass, volume, power and space readiness do not align with exploration
mission restrictions.
Technology Status - Global
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Exploration Laboratory Analysis (ELA)
To address this gap, an exploration lab analysis platform
technology for long-duration, exploration missions should:
- Be minimally invasive
- Be easy to use
- Promote crew autonomy
- Exhibit expanded assay capability
- Have extended shelf-life of consumables (e.g.
reagents, cartridges)
- Minimize mass, volume, power, and consumables
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Performance Consideration Value Comment
Shelf life, durables and consumables 36 months Storage under the exploration vehicle’s ambient environment conditions; no refrigeration
Operational life in space 36 months Survive possible high-energy and background radiation exposure
Reliable usage time 144 hours Battery power operability
Gravitational/residual acceleration 1, 0.38, 0.17, 10-5 g
Must operate on Earth, moon, near-Earth asteroid, Mars, and in low-Earth orbit
Consumables volume (includes reagents and disposables)
TBD (cm3) Depends on medical kit dimensions
Mass TBD (kg) Depends on medical kit dimensions
Power consumption TBD (W) Battery operation; vehicle back-up
Volume TBD (cm3) Depends on medical kit dimensions
ELA Performance Considerations
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ELA Operational Measurements
BasicMetabolic Panel
BloodGases Panel
Hematology Cardiac Panel
Liver Panel Urinalysis
GlucoseCalciumSodiumPotassiumCO2, TotalChlorideBUNCreatinine
PaO2
PaCO2
SaO2
HCO3
pH
WBC CountRBC CountHCTHgbNeutrophilsAbs.NeutrophilsCountLymphocytesMonocytesEosinophilsPLT
Troponin I AlbuminALPASTALT
Specific GravitypHLeukocytesNitritesProteinsGlucoseKetonesUrobilirubinBilirubinBlood
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ELA Reference Architecture
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ELA Operational Concept
Sample Acquisition Data Process
Functional Flow Block Diagram
Context Diagram
“Patient”:Crew Member
Operator:Crew Member
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ExMC Gap 4.05 Path to Risk Reduction
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Exploration DRMTech InsertionTech Insertion
Technology Assess
SRR (FY15)SDR
(FY17)Flt Demo
(FY 20)Grd Demo
(FY18)Down
Select (FY16)
Gap Closure
ELA Tech
Tech Watch
Tech Insertion Tech Insertion
Advancement to TRL 7 • Perform analysis with Blood/Urine
Samples (possible in-situ)• Usability and operations validation• Repeatability• Compare ELA system on ground
simultaneously with ELA system in microgravity environment
Advancement to TRL 6• Validation - optimize and benchmark
against a commercial, clinical instrument (gold standard in a laboratory environment)
• Blind Study verification
Analysis/Recommendation
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Summary• Space environment and missions present unique challenges for
biomedical instrumentation
– Microgravity (control of bubbles in microfluidics)
– Minimizing consumables and waste
– Accommodation by the exploration medical kit (mass, volume)
– Extended instrument performance throughout lengthy
deployments
– Extended shelf life
• Possible technological solutions are under investigation
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Thank You
Michael Krihak michael.k.krihak@nasa.gov
Ronak Shah ronak.v.shah@nasa.gov
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