Adaptable Fetal Heart Monitor Patient Interface

Reference#: P02260

Significant progress has been made in the science of electrocardiography since 1938. Heart rate and biophysical profiles are routinely derived from multi-lead electrocardiograms (ECGs) in animals and humans after birth. In contrast, only limited heart monitoring technologies exist for the fetus. Maximizing the health and well-being of the mother and fetus by appropriate medical intervention is the general goal of obstetrical care. Effective monitoring of a fetus may require continuous assessment, and is commonly performed using electronic technology. However, the escalation of the frequency of normal births by cesarean section has called into question the validity of present monitoring techniques with respect to specificity of identifying the fetus at risk. Reducing the number of unnecessary cesarean sections and, in general, reducing the number of babies that are seriously ill at birth has been raised as a national health care priority in an effort to reduce the cost of both short- and long-term health care.

Current technology fails to satisfy many existing needs in fetal ECG monitoring, both to support clinical assessment of fetal health and fundamental research on fetal development. The difficulties in monitoring fetal well-being have long been recognized by the medical profession. The variable position of the fetus within the womb, surrounded by the amnion and amniotic fluids makes direct examination of the fetus impossible or very difficult using most examination techniques. Present electronic fetal heart rate monitoring shows great sensitivity, but inadequate specificity, and poor positive predictive value in correlating fetal heart rate changes with subsequent adverse neonatal outcome. Such electronic fetal heart rate monitoring, despite these limitations, remains an integral part and standard of care in the assessment of fetal status.

The JHU Fetal Heart Rate Monitor (FHRM) monitors the fetal condition in an objective, quantitative, and non-invasive manner by enabling continuous and highly specific data collection during pre-natal development and the intra-partum period. This monitoring will aid in the fetal and maternal treatment planning regimen potentially earlier than presently feasible, thus facilitating or indicating interventions which may reduce maternal and fetal morbidity and mortality.

The FHRM is a reliable, accurate, and noninvasive technique to monitor the electrocardiogram of the fetus. It maintains a clear operative field, accommodates the movement of the mother and fetus, and is usable for a relevant portion of gestation. Moreover, it provides output to include the fetal electrocardiogram waveform in addition to the fetal heart rate and description of heart rate variability. Finally, the FHRM monitors maternal heart rate, the state of uterine contractions, and noise artifacts attributable to the uterus.

Patent Status: U.S. patent(s) 7869863 issued.

Mr. K. Chao
Phone: (443) 778-7927

Additional References:

Link to U.S. Patent and Trademark Office