PinMed, Inc. — Department of Defense SBIR Phase I: N212-125

Description

To help maintain the health and fitness of Navy dolphins, PinMed will adapt and extend its wearable, wireless, programmable, FDA-cleared ECG device (the Personal Electrocardiographic Expert, or PELEX) for continuous monitoring of cardiac rate, rhythm, and ECG waveforms in free-swimming and resting dolphins in the marine environment. The resulting PELEX-OCEAN system will also record the swimming depth of the animals (in sync with ECG). In addition to satisfying all contract specifications, the system will continuously record high-fidelity ECG waveforms, which are essential for the accurate, timely diagnosis and management of ischemia. Because the electronic design of the PELEX wireless ECG system (FDA cleared for wireless ECG transmission and long-term monitoring) fully meets the project requirements, in Phase I we will focus on the following tasks: 1) selection of elastic materials and design and manufacturing of a wearable jacket for holding ECG electrodes and device; 2) selection of the optimal locations for ECG electrodes; 3) ECG electrode design optimization with respect to the dolphin’s motion artifacts and long-term seawater exposure; and 4) selection and testing of a depth-measurement sensor, which will be integrated with the system in Phase II. In Phase I, the prototype design will be tested in a realistic model of a dolphin body in a seawater tank and evaluated by dolphin experts from the National Marine Mammal Foundation (NMMF). The main innovations (outcomes) of of Phase I include: a prototype wearable jacket, which will be integrated with the PELEX ECG system for long-term ECG monitoring in free-swimming dolphins, and optimal ECG electrode location for continuous, reliable data collection and more accurate diagnosis of arrhythmias and ischemia in free-swimming dolphins.