Advancing the Pulmonary Assist System for Military Transport
Abstract
The purpose of this proposal is to further develop a commercial Pulmonary Assist System (PAS). The PAS is designed to provide compact lightweight life support for wounded soldiers during military transport. Wounded Soldiers can develop a condition known as acute lung injury, or ALI, in which their lungs are not able to properly add oxygen to and remove carbon dioxide from their blood. The most advanced form of life support, extracorporeal life support or ECLS, can function to perform the work of the lungs, but it is currently difficult to deploy near the battlefield primarily due to the large size and weight of the equipment and the rapid blood clotting that occurs in system components. The clotting causes the devices to clog and fail, which necessitates the use of drugs known as anticoagulants to prevent clotting. However, these drugs cause patient bleeding. This results in a need to constantly monitor patients to balance clotting and bleeding risk. Due to these problems, ECLS is currently only used on a limited basis for transportation of wounded Soldiers. Currently, the military relies on a specialized team located in the United States to travel to the location of a wounded Soldier with ALI to start ECLS treatment. This results in 1-2 days passing before a wounded Soldier can be treated with ECLS. The PAS ECLS system that we are developing would enable the most advanced form of life support to be deployed closer to the battlefield, immediately after injury, rather than waiting for a transport team to reach the patient from the United States. The PAS would then be used to support wounded Soldiers as they are moved through progressively more advanced field hospitals until they are ultimately transported back to the United States or Europe. The PAS weighs only 2.3 kg, is highly mobile, has greater durability to avoid component failure and replacement, can be used without employing anticoagulant drugs until the patient is transported to more advanced care, and can be run on battery power to allow simpler transport of the injured Warfighter from remote combat operations to higher levels of care in the United States. Thus, this project addresses the Trauma Topic Area and the Develop improved fieldable devices to treat traumatic/acute lung injury in far forward settings, including toolsets to enable correct airway placement, oxygenation in austere settings, or miniature and/or semi-automated ventilator Focus Area. We have demonstrated the PAS performance using prototype systems, and we are now ready to work toward approval from the Food and Drug Administration (FDA) to enable support of injured Soldiers. The first objective of this proposal is to generate the procedures and documentation that are required by the FDA to gain approval for the PAS gas exchanger (PAS-GE). The PAS-GE is the component necessary to support the patient s lung function. The second objective of this proposal is to generate a final commercial design of the PAS-GE that not only satisfies FDA requirements, but that is also durable and simple to manufacture in large quantities without manufacturing defects. A significant portion of the work will be designing the plastic parts so that they can be manufactured successfully. Part of ensuring this outcome will be performing computer simulations of the molding process to identify areas of the plastic parts that may result in defects and then adjusting the design to eliminate the defects. The last objective of this proposal is to build and fine-tune a pilot manufacturing line to make the textile component of the PAS-GE. The PAS-GE uses a custom-coated fabric composed of hollow tube-like fibers that perform its oxygen and carbon dioxide transfer function. The previous supplier of this custom-coated fiber was bought by a larger corporation, 3M, who then stopped performing the final processing steps for this fiber. We will purchase two pieces of custom machinery that will knit the f
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252310508
Entities
People
- David Skoog
Organizations
- United States Army