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 dolphins 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.
Benefit: Although short-term ECG recordings provide important insights into the dolphins cardiac electrophysiology, the true incidence of cardiac events during various types of physical activity in free-swimming dolphins is largely unknown due to the absence of ECG monitors that can work reliably in the marine environment. PELEX-OCEAN will provide an accurate assessment of the dolphins cardiac health and fitness and will more accurately capture cardiac (arrhythmic and ischemic) events, which are usually provoked by physical activity (e.g., fast swimming or diving). Because PELEX-OCEAN will be the first system to provide continuous, multi-lead monitoring of ECG and physical activity in a natural aquatic environment, it will have a number of applications and prospective users. In addition to dolphin monitoring, the PELEX-OCEAN system could be adapted for monitoring ECG in other aquatic animals by modifying the jacket size and shape. Through scientific presentations, meetings, and publications, we will share the results of testing PELEX-OCEAN in free-swimming dolphins by NMMF, a recognized leader in marine mammal health, with the scientific community, including thought leaders from veterinary-medicine academic departments, clinics, conservation and research institutions, and the marine mammal health-management industry for zoos, aquariums, parks, and managed-care facilities specializing in aquatic animals. In Phase III, we will extend PELEX-OCEAN to human subjects (by modifying the shape/size of the jacket), including Navy divers and other commercial/recreational divers. Because the background ECG technology (PELEX) has been cleared by the FDA for multiple ECG tests in non-aquatic settings, we anticipate that regulatory testing of PELEX-OCEAN and subsequent preparation of a 510(k) submission will be completed within a year. We will reach out to Navy diving units (e.g., Navy Underwater Construction Teams) and to the professional and recreational diving industry. In addition, we will explore potential markets such as aquatic rehabilitation, fitness, and professional athletes.
Keywords: electrocardiographic monitoring, electrocardiographic monitoring, ECG Monitoring, wearable ECG, cardiac monitoring, Electrocardiogram
