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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


19 August 2015

Blood, Sweat and Tears Workshop 2

Overview

• Exploration Medical Capability (ExMC)

• Vital Signs Monitoring

• Laboratory Analysis



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


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.


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:


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/


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


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


Medical Risk & ExMC Gap



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.


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


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


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


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.


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


EXPLORATION LABORATORY ANALYSIS (ELA)

Medical Capabilities for Exploration Spaceflight

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Medical Risk & ExMC Gap



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


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


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


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


ELA Reference Architecture


ELA Operational Concept

Sample Acquisition Data Process

Functional Flow Block Diagram

Context Diagram

“Patient”:Crew Member

Operator:Crew Member


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


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


Thank You

Michael Krihak [email protected]

Ronak Shah [email protected]

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mailto:[email protected]

mailto:[email protected]

Documents

Medical Capabilities for Exploration Spaceflight - · PDF file•Body Temperature ... • 12-lead ECG diagnostic system ... Medical Capabilities for Exploration Spaceflight 19. Blood,