Conformal, Portable External Fetal Heart Monitor

DESCRIPTION (provided by applicant): External fetal heart monitors (FHM) allow for intermittent or continuous monitoring of fetal status both before and during labor, and reduce medical costs by allowing fewer nurses or midwives to manage larger number patients. However, current external FHMs are cumbersome in design, leading a significant negative impact on patient comfort and mobility. External FHMs are rigid, require straps to maintain their position on the abdomen, and are typically tethered to a largefetal monitoring system. During continuous monitoring, the patient's movements and positions are considerably restricted, so as not to perturb the position of the FHM and compromise the fidelity of the fetal heart rate signal. Loss of the fetal heartrate signal leads to false alarms and unnecessary patient anxiety. In addition, the false alarms result in increased medical costs, due to the need for nurses or midwives to frequently reposition the transducer on the abdomen. Farus, in collaboration with Tenacore Holdings, proposes to assess the feasibility of a vastly improved FHM that will improve patient care, eliminate the need for repositioning, and in turn reduce medical costs. The improved FHM will be soft and conformal, improving patient comfort comparedto rigid probes. More importantly, a conformal FHM will better maintain positioning on the abdomen even during movement of the patient, therefore allowing the patient improved freedom of movement and reducing the shifting of the transducer positioning andloss of the fetal heartbeat. Further, the improved FHM will incorporate wireless telemetry, including a lightweight battery-operated system, eliminating the need for cabling to the fetal monitor. The light weight and flexibility of the conformal FHM willalso enable the use of adhesion methods that can eliminate the use of adjustable straps. Together, we believe these innovations will significantly improve patient comfort, acceptance, mobility, and satisfaction, and reduce alarm rates and labor costs associated with patient monitoring. Discussions with clinicians, patients, and customers have indicated that the conformal, wireless technology would address a long-ignored need in the 65M+ external fetal heart monitoring market. Farus has extensive development experience with flexible ultrasound devices and systems, and Tenacore is a leading manufacturer and supplier of rigid FHMs to over 1200 hospitals in both the U.S. and Europe. We believe the combined experience will lead to the successful design and development and a relatively straightforward path to market. The objective of this Phase I SBIR effort is to demonstrate the feasibility of the conformal, wireless FHM approach. Three Specific Aims will be conducted to meet the objective: (1) fabrication a conformal FHM; (2) implementation of a wireless telemetry and adhesion system; and (3) acoustic testing of the conformal FHM to ensure predicted and consistent performance and compliance with FDA safety regulations. PUBLIC HEALTH RELEVANCE: Current external fetal heart monitors (FHM) are rigid, require straps to maintain their position on the abdomen, and are typically tethered to a cart-based fetal monitoring system. The cumbersome design of existing external FHMs has a significant negative impact on patient comfort and mobility and causes shifting of the FHM on the abdomen and frequent loss of the fetal heartrate signal. This Phase I SBIR proposes to assess the feasibility of a conformal, wireless FHM that may improve freedom of movement, reduce falsealarms and patient anxiety, and reduce labor costs associated with patient monitoring.