SIMETRI, INC. — Department of Defense SBIR Phase I: The U.S. Army has a requirement to develop a simulation-based training system to assist te

Description

The U.S. Army has a requirement to develop a simulation-based training system to assist teaching and training the use of intraosseous (IO) devices in the humeral head to administer fluid to patients at point of injury. Through this Phase I SBIR effort, SIMETRI proposes to produce a prototype, proof-of-concept device, training aids, and training analysis that will demonstrate means to meet the Army"s expectations for a part-task trainer (PTT) that teaches students to find the correct anatomical landmarks; to insert the needle at the correct location and at the proper angle; to verify proper insertion; and to insert the catheter in the proper way to introduce fluids. SIMETRI"s strategy for Phase I consists of the following steps. 1. Conduct research into appropriate materials and training methods. 2. Construct and demonstrate a prototype, proof-of-concept training device (single arm). 3. Produce a training video / animation which demonstrates to students how to perform an insertion. 4. Analyze the costs and benefits of an expanded training device (full torso) which would incorporate the technologies developed for the proof-of-concept device. The Phase I proof-of-concept device will represent a single arm, and will consist of the following major components: Bones (replaceable) and joints with realistic feel; Fat, muscle, and skin with realistic feel and appropriate anatomical landmarks; and Attachment points, for possible future attachment to a full torso. In order to make effective use of IO devices in training, the Phase I device will be constructed to satisfy the following requirements: Ability to incorrectly/correctly palpate a realistic-feeling humerus underneath the skin/muscle tissue layers Ability to incorrectly/correctly position the needle and puncture through simulated skin/muscle tissue at the correct/incorrect angle Ability to incorrectly/correctly insert the needle through the simulated skin/muscle tissue and simulated bone using the EZ IO drill Ability to anchor the catheter into the simulated arm Ability to attach a syringe and apply negative pressure for confirmation of correct needle location (through visual indication of red fluid being pulled into the tubing) Ability to introduce fluids through the EZ IO catheter which will be consumed by the device, with a swelling effect if the insertion has missed the bone completely The Phase I device will feature reusable and replaceable simulated skin, muscle, and bone. This modular approach minimizes the expendable items that must be replaced throughout the life of the device. The Phase I device will also maximize the use of COTS items to reduce cost and to improve maintainability; for example, injectable simulated bones will be sourced from Sawbones, instead of manufacturing custom components in-house. A training video / animation will be produced to accompany the Phase I device. This video will present a simple demonstration of the use of the EZ IO kit to students before they attempt to perform procedures on the training device. Phase I will conclude with a demonstration of the prototype device and submittal of a report on the costs (including total lifecycle cost), benefits, and effectiveness of the PTT for IO training as an adjunct to the Program of Instruction (POI) at the US Army Center for Pre-Deployment Medicine (CPDM) at Fort Sam Houston, Texas. If awarded, Phase II will continue the PTT development by expanding the device to represent the entire torso supporting both left and right insertions on the same training device. The Phase II device will refine the technologies and methods used in producing the Phase I device, and will address the following additional training requirements: Ability to incorrectly/correctly position arms over the umbilicus, with realistic arm range of motion Ability to perform insertions in either left or right arm A usability and training effectiveness study will be conducted in Phase II with Army medical trainees, under established human study protocols (including review by an IRB). The study will be streamlined through the use of TESTER, a training effectiveness evaluation tool already delivered to U.S. Army Research Laboratory under a previous effort led by SIMETRI.