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Project Title:  Spaceflight Injectable Delivery System Reduce
Fiscal Year: FY 2012 
Division: Human Research 
Research Discipline/Element:
HRP ExMC:Exploration Medical Capabilities
Start Date: 10/01/2008  
End Date: 12/30/2011  
Task Last Updated: 09/20/2012 
Download report in PDF pdf
Principal Investigator/Affiliation:   Weaver, Aaron  Ph.D. / NASA Glenn Research Center  
Address:  21000 Brookpark Road 
Mail Stop 110-3 
Cleveland , OH 44135 
Email: Aaron.S.Weaver@nasa.gov 
Phone: (216) 433-3757  
Congressional District: 10 
Web:  
Organization Type: NASA CENTER 
Organization Name: NASA Glenn Research Center  
Joint Agency:  
Comments:  
Project Information: Grant/Contract No. Directed Research 
Responsible Center: NASA JSC 
Grant Monitor: Watkins, Sharmi1a  
Center Contact: 281.483.0395 
sharmila.watkins@nasa.gov 
Solicitation / Funding Source: Directed Research 
Grant/Contract No.: Directed Research 
Project Type: GROUND 
Flight Program:  
TechPort: Yes 
No. of Post Docs:
No. of PhD Candidates:
No. of Master's Candidates:
No. of Bachelor's Candidates:
No. of PhD Degrees:
No. of Master's Degrees:
No. of Bachelor's Degrees:
Human Research Program Elements: (1) ExMC:Exploration Medical Capabilities
Human Research Program Risks: (1) ExMC:Risk of Unacceptable Health and Mission Outcomes Due to Limitations of In-flight Medical Capabilities (IRP Rev E)
Human Research Program Gaps: (1) ExMC 4.25:We do not have the capability to deliver injectable medication to a suited crewmember during exploration missions (IRP Rev E)
Flight Assignment/Project Notes: NOTE: Per the Human Research Roadmap and HRP Master Task List, the project is currently in an archived state. End date changed to 12/30/2011; original end date was 9/30/2014 (Ed., 9/20/2012)

Task Description: In the event of an emergency during spaceflight, it may be necessary for the crew to find extended safety in their Extra-Vehicular Activity (EVA) spacesuits. During this EVA contingency, NASA requires the capability to deliver liquid medications via intramuscular injection to ill or injured crewmembers. The delivery of liquid medication in a damaged vehicle unable to maintain a habitable environment poses unique challenges. Some of these challenges include the behavior of the fluid in a low-pressure and off-nominal-temperature environment, the formation of bubbles in microgravity, and the ability to physically use the medical delivery device at the desired anatomical location while the astronaut is suited. Under the auspices of NASA’s Human Research Program, the In-Suit Injection System project at the Glenn Research Center (GRC) aims to develop an injection device capable of delivering necessary medications during an EVA contingency.

Research Impact/Earth Benefits: This technology development project aims to design a medical injection device for the harsh environment of space. This technology could translate to harsh Earth environments such as during underwater diving or during a hazardous materials/chemicals scenarios requiring the user to be in a containment suit.

Task Progress & Bibliography Information FY2012 
Task Progress: [Editor's Note September 2012: the following from the Human Research Roadmap http://humanresearchroadmap.nasa.gov/tasks/?i=893 ; Per the Human Research Roadmap and HRP Master Task List, the project is currently in an archived state. End date changed to 12/30/2011; original end date was 9/30/2014 ]

The Injectables task successfully completed PDR (preliminary design review) in September of 2011. At that time, it was felt that the forward need for an injection device was too undefined to further proceed with the project. With uncertainty in the needs of the suit developers (Injectables was conceived under Constellation Program and was working under those mission scenarios), new and uncertain Design Reference Missions (DRMs), and uncertainty from the medical community on what needed to be provided because of the changing DRMs, the Injectables task was put on hold. The project is currently in an archived state that will allow for continued development if the need arises.

Bibliography Type: Description: (Last Updated: ) 

Show Cumulative Bibliography Listing
 
 None in FY 2012
Project Title:  Spaceflight Injectable Delivery System Reduce
Fiscal Year: FY 2011 
Division: Human Research 
Research Discipline/Element:
HRP ExMC:Exploration Medical Capabilities
Start Date: 10/01/2008  
End Date: 12/30/2011  
Task Last Updated: 12/13/2011 
Download report in PDF pdf
Principal Investigator/Affiliation:   Weaver, Aaron  Ph.D. / NASA Glenn Research Center  
Address:  21000 Brookpark Road 
Mail Stop 110-3 
Cleveland , OH 44135 
Email: Aaron.S.Weaver@nasa.gov 
Phone: (216) 433-3757  
Congressional District: 10 
Web:  
Organization Type: NASA CENTER 
Organization Name: NASA Glenn Research Center  
Joint Agency:  
Comments:  
Project Information: Grant/Contract No. Directed Research 
Responsible Center: NASA JSC 
Grant Monitor: Watkins, Sharmi1a  
Center Contact: 281.483.0395 
sharmila.watkins@nasa.gov 
Solicitation / Funding Source: Directed Research 
Grant/Contract No.: Directed Research 
Project Type: GROUND 
Flight Program:  
TechPort: Yes 
No. of Post Docs:
No. of PhD Candidates:
No. of Master's Candidates:
No. of Bachelor's Candidates:
No. of PhD Degrees:
No. of Master's Degrees:
No. of Bachelor's Degrees:
Human Research Program Elements: (1) ExMC:Exploration Medical Capabilities
Human Research Program Risks: (1) ExMC:Risk of Unacceptable Health and Mission Outcomes Due to Limitations of In-flight Medical Capabilities (IRP Rev E)
Human Research Program Gaps: (1) ExMC 4.25:We do not have the capability to deliver injectable medication to a suited crewmember during exploration missions (IRP Rev E)
Flight Assignment/Project Notes: NOTE: Per the Human Research Roadmap and HRP Master Task List, the project is currently in an archived state. End date changed to 12/30/2011; original end date was 9/30/2014 (Ed., 9/20/2012)

Task Description: In the event of an emergency during spaceflight, it may be necessary for the crew to find extended safety in their Extra-Vehicular Activity (EVA) spacesuits. During this EVA contingency, NASA requires the capability to deliver liquid medications via intramuscular injection to ill or injured crewmembers. The delivery of liquid medication in a damaged vehicle unable to maintain a habitable environment poses unique challenges. Some of these challenges include the behavior of the fluid in a low-pressure and off-nominal-temperature environment, the formation of bubbles in microgravity, and the ability to physically use the medical delivery device at the desired anatomical location while the astronaut is suited. Under the auspices of NASA’s Human Research Program, the In-Suit Injection System project (ISIS) at the Glenn Research Center (GRC) aims to develop an injection device capable of delivering necessary medications during an EVA contingency.

Research Impact/Earth Benefits: This technology development project aims to design a medical injection device for the harsh environment of space. This technology could translate to harsh Earth environments such as during underwater diving or during a hazardous materials/chemicals scenarios requiring the user to be in a containment suit.

Task Progress & Bibliography Information FY2011 
Task Progress: In the event of an emergency during spaceflight, it may be necessary for the crew to find extended safety in their Extra-Vehicular Activity (EVA) spacesuits. During this EVA contingency, NASA requires the capability to deliver liquid medications via intramuscular injection to ill or injured crewmembers. The delivery of liquid medication in a damaged vehicle unable to maintain a habitable environment poses unique challenges. Some of these challenges include the behavior of the fluid in a low-pressure and off-nominal-temperature environment, the formation of bubbles in microgravity, and the ability to physically use the medical delivery device at the desired anatomical location while the astronaut is suited. Under the auspices of NASA’s Human Research Program, the In-Suit Injection System project (ISIS) at the Glenn Research Center (GRC) aims to develop an injection device capable of delivering necessary medications during an EVA contingency.

During this task book reporting period, preliminary testing was performed to determine appropriate components for a device. After this testing, a prototype device was designed, fabricated, and tested.

In order to design and build a prototype injection device, preliminary testing was completed to determine key components. This testing included human factors elements, computational modeling, and vacuum chamber testing.

To determine the best geometry for ease of device use, many different sized and shaped commercially available syringes were taken to the Johnson Space Center (JSC) for testing. There, they were placed in a glovebox, which creates a pressure differential equal to what astronauts would experience in while in their EVA suits. To interface with the syringes, the operator donned standard EVA gloves. While in the glovebox, the operator then unpacked, assembled, and mock injected the syringes into a ballistic gel to simulate the use of the syringe from start to finish. From this testing, it was determined that any commercial style syringe would be too difficult to use in a gloved situation. This testing also helped determine the appropriate diameter for the injection device.

Another challenge for the injection device will be the thermal environment to which it will be subjected. To examine how long it will take liquid medication to reach a temperature point outside of acceptable limits, computational fluids models were developed using COMSOL Multiphysics Software (Burlington, MA). From the developed models, it was determined that some of the medication will reach its viability limit within 25 seconds of being exposed to the environment, and that it would take 7-7.5 hours for it to reach 99% steady state without thermal conditioning.

Finally, to determine how best to interface a needled injection device with an EVA suit, testing was performed on rubber septa. Medicinal vials, sealed by differing combinations of septa material were punctured by a needle. Using either force gauges or a vacuum chamber, the septa were tested in an ambient environment, a low-temperature environment, and a low-pressure environment. From this testing, it was determined that an 1/8-inch-thick septa with two possible coatings would be most effective for the device interface.

Informed by the preliminary testing and by consultation with Johnson Space Center (JSC) flight medical staff, a prototype injection system was designed and fabricated. The main goal of the prototype was to demonstrate the capability to deliver liquid medication while emphasizing crew safety and protecting the medication from the outside environment. Key components of the device include:

• Spring-loaded design to allow for push-button operation

• Simple operation to allow crew to inject themselves or crewmates

• External housing to enclose an internal syringe and needle

• Two-layer safety mechanism to prevent inadvertent deployment

• Mechanical design to ensure medication is not delivered until needle has penetrated the muscle

• Optional adapter to allow for operation outside of the EVA suit.

Solid models of the device before it has been triggered (“Ready” state), when the needle has been deployed (“Injected” state), and when the medication has been delivered (“Delivered” state) have been demonstrated. From the “Ready” state, a push button is depressed releasing the first set of springs. These springs translate the syringe through the external housing until the needle has penetrated the muscle. After hitting a mechanical stop, a second spring depresses the plunger of the syringe, delivering the medication. The external housing protects the medication from the external environment.

After fabrication of the prototype, testing was performed to validate design characteristics. The injector, filled with liquid, was placed in a vacuum (0.04 psia) and showed no evidence of leakage. The device was also tested in a chamber to simulate the pressure of the EVA suit. From this testing it was shown that the needle will be able to penetrate the injection interface, and that the medication does not prematurely deploy before the needle has entered the muscle. Finally, operation using a gloved hand was tested to explore ease of operation.

Bibliography Type: Description: (Last Updated: ) 

Show Cumulative Bibliography Listing
 
 None in FY 2011
Project Title:  Spaceflight Injectable Delivery System Reduce
Fiscal Year: FY 2009 
Division: Human Research 
Research Discipline/Element:
HRP ExMC:Exploration Medical Capabilities
Start Date: 10/01/2008  
End Date: 12/30/2011  
Task Last Updated: 11/06/2009 
Download report in PDF pdf
Principal Investigator/Affiliation:   Weaver, Aaron  Ph.D. / NASA Glenn Research Center  
Address:  21000 Brookpark Road 
Mail Stop 110-3 
Cleveland , OH 44135 
Email: Aaron.S.Weaver@nasa.gov 
Phone: (216) 433-3757  
Congressional District: 10 
Web:  
Organization Type: NASA CENTER 
Organization Name: NASA Glenn Research Center  
Joint Agency:  
Comments:  
Co-Investigator(s)
Affiliation: 
McQuillen, John  NASA Glenn Research Center 
Project Information: Grant/Contract No. Directed Research 
Responsible Center: NASA JSC 
Grant Monitor: Watkins, Sharmi1a  
Center Contact: 281.483.0395 
sharmila.watkins@nasa.gov 
Solicitation / Funding Source: Directed Research 
Grant/Contract No.: Directed Research 
Project Type: GROUND 
Flight Program:  
TechPort: Yes 
No. of Post Docs:  
No. of PhD Candidates:  
No. of Master's Candidates:  
No. of Bachelor's Candidates:  
No. of PhD Degrees:  
No. of Master's Degrees:  
No. of Bachelor's Degrees:  
Human Research Program Elements: (1) ExMC:Exploration Medical Capabilities
Human Research Program Risks: (1) ExMC:Risk of Unacceptable Health and Mission Outcomes Due to Limitations of In-flight Medical Capabilities (IRP Rev E)
Human Research Program Gaps: (1) ExMC 4.25:We do not have the capability to deliver injectable medication to a suited crewmember during exploration missions (IRP Rev E)
Flight Assignment/Project Notes: NOTE: Per the Human Research Roadmap and HRP Master Task List, the project is currently in an archived state. End date changed to 12/30/2011; original end date was 9/30/2014 (Ed., 9/20/2012)

Task Description: The goal of this task is to provide a means of injecting potentially lifesaving medications to a crewmember during the 144-hour contingency that requires the astronauts to wear their EVA suits. The task assumes that the crewmember is in a low pressure, low temperature environment. The challenge of this task is to develop a device to deliver medication to the crewmember inside the suit under these harsh conditions.

Under this effort, system components will be evaluated to determine physical properties. This includes how fluids behave in a low-temperature, low-pressure environment, how to exclude bubbles, and concepts for storage and filling of medications in a low-temperature, low-pressure environment.

Specific Key Performance Parameters (KPPs) are defined below.

An 18-gauge needle will be used, if a needle is chosen as the delivery vehicle through the skin.

The system will not increase the transient vehicle-dependant leak rate by more than TBD sccm for EVA suit pressure

The system will need to be simple enough to use to be operated by a pressurized, gloved hand at EVA pressure.

The system will have a minimum lifetime of 40 injections.

This technology development (TD) task will be considered successful if,

Technology and processes are developed to interface an injection device with the EVA suit.

Technology and processes are developed to provide injections in a low-temperature environment.

Technology and processes are developed to provide injections in a low-pressure environment.

Technology and processes are developed to fill the proper medications into an injection device in a low-temperature, low-pressure environment.

Technology and processes are developed to store the proper medications in a low-temperature, low-pressure environment.

Research Impact/Earth Benefits: 0

Task Progress & Bibliography Information FY2009 
Task Progress: New project for FY2009.

Bibliography Type: Description: (Last Updated: ) 

Show Cumulative Bibliography Listing
 
 None in FY 2009