Non-invasive Fetal Heart Signature Monitor

Reference#: P01231

Regardless of the monitoring technique, critical difficulties frequently arise when there is an emergent need to transfer the monitored patient from the labor area to the operating room. The monitors are usually detached during this critical interval with the mother and her fetus unmonitored during the transfer. Reattachment to monitors in the operating room (if at all) requires additional, possibly precious time and attention. Doppler transducers, if used, are inevitably in the operative field for an emergency cesarean section. Likewise, scalp electrodes must be removed or cut and withdrawn with the baby through the abdominal incision, again increasing the risk of infection.

The present invention non-invasively and passively measures fetal and maternal electrocardiographic and maternal electromyographic waveforms by using traditional surface electrode electrocardiographic and electromyographic techniques combined with adaptive signal processing methods. The invention provides patient information (e.g., fetal heart rate/variability, taking into account noise artifacts attributable to uterine contractions) that at least duplicates current clinical standards.

In particular, the invention uses, for example, suitable skin contact electrodes connected to amplifiers to acquire biopotential waveforms and form signals, preferably differential signals, indicative of the mother's heart beat from sensors, e.g., electrodes, placed on her chest, and indicative of the combined maternal and fetal heart beats from sensors placed on the mother's abdomen, lower back, or both, as well as electromyographic signatures indicative of noise artifacts attributable to changes in uterine tone. Maternal heart rate, heart rate variability, and respiration rate are derived from the chest signals; standard maternal EKG is derived from planar leads. Instead of differential signals, more vectors may be formed by collecting single-ended signals and creating "differential pairs" therefrom.

The sensors placed on the mother's abdomen, lower back, or both, are preferably placed to form pairs of sensors wherein each sensor of the pair is spaced from the other and each pair is positioned in a substantially criss-crossed pattern with respect to other sensor pairs. Substantial spacing between the sensors of each sensor pair and between pairs of sensors is preferred so as to achieve a three-dimensional processing of the fetal biopotential waveform. By sensing the combined fetal and maternal waveforms with a multiplicity of sensors, the uniqueness of the vectors can be used to establish the vector orientation of the fetus. Preferably, the number of vectors used is sufficient to achieve a clear signal indicative of the combined fetal and maternal waveforms. If a clear enough combined signal is obtained from a single sensor, the present invention can operate using a single sensor to obtain the combined waveform.

Signals from the abdominal electrodes are divided into a plurality of channels. After data validation, an adaptive signal processing filter (ASPF) algorithm or other suitable algorithm is used to cancel the estimated maternal waveform from each channel in the abdominal electrodes, using chest signals as references. The system then selects from at least one of the resulting waveforms to serve as the reference fetal waveform. Using another ASPF or other suitable algorithm, the reference waveform is then processed against the other abdominal waveforms with the maternal waveforms canceled to form an enhanced fetal signal that is a representation of the EKG.sub.f.. Surface electromyogram (EMG) signals allow for concurrent monitoring of uterine contractions and afford improved cancellation of motion artifacts.

This invention is totally non-invasive, passive and will supplant the fetal scalp electrode and, therefore, eliminate those risks of infection. The placement of the electrodes maintains a clear surgical field, thereby facilitating operative procedures such as cesarean section deliveries, and will not interfere with resuscitation of the mother, should either become necessary. There is no need to tend to the device and reposition electrodes as the fetus moves, thereby allowing health professional time and attention to be directed toward more productive patient care activities. This invention is capable of determining the instantaneous orientation of the fetal heart vector, thereby indicating the orientation of the fetus and permitting prediction of delivery complications associated with atypical presentation. It also provides a means to monitor multiple gestations with no additional sensors being required.

Patent Status: U.S. patent(s) 6751498 issued.

*Available for licensing.

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