Preterm birth is the leading cause of worldwide neonatal mortality. It follows a pathologically accelerated form of the normal processes that govern cervical softening and dilation. Softening and dilation occur due to changes in cervical collagen crosslinking, which can be measured non-invasively by changes in tissue fluorescence and impedance. We present a novel device designed specifically to take fluorescence and impedance measurements throughout pregnancy, with the end goal of fusing and trending these measurements to form an early diagnosis of preterm labor.

Preterm birth causes 1 million infant deaths worldwide every year, making it the leading cause of infant mortality. Existing diagnostic tests such as transvaginal ultrasound or fetal fibronectin either cannot determine if preterm birth will occur in the future or can only predict the occurrence once cervical shortening has begun, at which point it is too late to reverse the accelerated parturition process. Using iterative and rapid prototyping techniques, we have developed an intravaginal proof-of-concept device that measures both cervical bioimpedance and cervical fluorescence to characterize microstructural changes in a pregnant woman's cervix in hopes of detecting preterm birth before macroscopic changes manifest in the tissue. If successful, such an early alert during this "silent phase" of the preterm birth syndrome may open a new window of opportunity for interventions that may reverse and avoid preterm birth altogether.

We present a low power multi-modal patch designed for measuring activity, altitude (based on high-resolution barometric pressure), a single-lead electrocardiogram, and a tri-axial seismocardiogram (SCG). Enabled by a novel embedded systems design methodology, this patch offers a powerful means of monitoring the physiology for both patients with chronic cardiovascular diseases, and the general population interested in personal health and fitness measures. Specifically, to the best of our knowledge, this patch represents the first demonstration of combined activity, environmental context, and hemodynamics monitoring, all on the same hardware, capable of operating for longer than 48 hours at a time with continuous recording. The three-channels of SCG and one-lead ECG are all sampled at 500 Hz with high signal-to-noise ratio, the pressure sensor is sampled at 10 Hz, and all signals are stored to a microSD card with an average current consumption of less than 2 mA from a 3.7 V coin cell (LIR2450) battery. In addition to electronic characterization, proof-of-concept exercise recovery studies were performed with this patch, suggesting the ability to discriminate between hemodynamic and electrophysiology response to light, moderate, and heavy exercise.

Biologically inert elastomers such as silicone are favorable materials for medical device fabrication, but forming and curing these elastomers using traditional liquid injection molding processes can be an expensive process due to tooling and equipment costs. As a result, it has traditionally been impractical to use liquid injection molding for low-cost, rapid prototyping applications. We have devised a method for rapid and low-cost production of liquid elastomer injection molded devices that utilizes fused deposition modeling 3D printers for mold design and a modified desiccator as an injection system. Low costs and rapid turnaround time in this technique lower the barrier to iteratively designing and prototyping complex elastomer devices. Furthermore, CAD models developed in this process can be later adapted for metal mold tooling design, enabling an easy transition to a traditional injection molding process. We have used this technique to manufacture intravaginal probes involving complex geometries, as well as overmolding over metal parts, using tools commonly available within an academic research laboratory. However, this technique can be easily adapted to create liquid injection molded devices for many other applications.

Congenital pulmonary hypoplasia is a devastating condition affecting fetal and newborn pulmonary physiology, resulting in great morbidity and mortality. The fetal lung develops in a fluid-filled environment. In this work, we describe a novel, implantable pressure sensing and recording device which we use to study the pressures present in the fetal pulmonary tree throughout gestation. The system achieves 0.18 cm H2O resolution and can record for twenty one days continuously at 256 Hz. Sample tracings of in vivo fetal lamb recordings are shown.

Goal

Our objective is to provide a framework for extracting signals of interest from the wearable seismocardiogram (SCG) measured during walking at normal (subject's preferred pace) and moderately fast (1.34-1.45 m/s) speeds.

Methods

We demonstrate, using empirical mode decomposition (EMD) and feature tracking algorithms, that the pre-ejection period (PEP) can be accurately estimated from a wearable patch that simultaneously measures electrocardiogram and sternal acceleration signals. We also provide a method to determine the minimum number of heartbeats required for an accurate estimate to be obtained for the PEP from the accelerometer signals during walking.

Results

The EMD-based denoising approach provides a statistically significant increase in the signal-to-noise ratio of wearable SCG signals and also improves estimation of PEP during walking.

Conclusion

The algorithms described in this paper can be used to provide hemodynamic assessment from wearable SCG during walking.

Significance

A major limitation in the use of the SCG, a measure of local chest vibrations caused by cardiac ejection of blood in the vasculature, is that a user must remain completely still for high-quality measurements. The motion can create artifacts and practically render the signal unreadable. Addressing this limitation could allow, for the first time, SCG measurements to be obtained reliably during movement-aside from increasing the coverage throughout the day of cardiovascular monitoring, analyzing SCG signals during movement would quantify the cardiovascular system's response to stress (exercise), and thus provide a more holistic assessment of overall health.

BACKGROUND:Remote monitoring of patients with heart failure (HF) using wearable devices can allow patient-specific adjustments to treatments and thereby potentially reduce hospitalizations. We aimed to assess HF state using wearable measurements of electrical and mechanical aspects of cardiac function in the context of exercise. METHODS AND RESULTS:Patients with compensated (outpatient) and decompensated (hospitalized) HF were fitted with a wearable ECG and seismocardiogram sensing patch. Patients stood at rest for an initial recording, performed a 6-minute walk test, and then stood at rest for 5 minutes of recovery. The protocol was performed at the time of outpatient visit or at 2 time points (admission and discharge) during an HF hospitalization. To assess patient state, we devised a method based on comparing the similarity of the structure of seismocardiogram signals after exercise compared with rest using graph mining (graph similarity score). We found that graph similarity score can assess HF patient state and correlates to clinical improvement in 45 patients (13 decompensated, 32 compensated). A significant difference was found between the groups in the graph similarity score metric (44.4±4.9 [decompensated HF] versus 35.2±10.5 [compensated HF]; P<0.001). In the 6 decompensated patients with longitudinal data, we found a significant change in graph similarity score from admission (decompensated) to discharge (compensated; 44±4.1 [admitted] versus 35±3.9 [discharged]; P<0.05). CONCLUSIONS:Wearable technologies recording cardiac function and machine learning algorithms can assess compensated and decompensated HF states by analyzing cardiac response to submaximal exercise. These techniques can be tested in the future to track the clinical status of outpatients with HF and their response to pharmacological interventions.

Background

To estimate oxygen uptake (VO₂) from cardiopulmonary exercise testing (CPX) using simultaneously recorded seismocardiogram (SCG) and electrocardiogram (ECG) signals captured with a small wearable patch. CPX is an important risk stratification tool for patients with heart failure (HF) owing to the prognostic value of the features derived from the gas exchange variables such as VO₂. However, CPX requires specialized equipment, as well as trained professionals to conduct the study.

Methods and results

We have conducted a total of 68 CPX tests on 59 patients with HF with reduced ejection fraction (31% women, mean age 55 ± 13 years, ejection fraction 0.27 ± 0.11, 79% stage C). The patients were fitted with a wearable sensing patch and underwent treadmill CPX. We divided the dataset into a training-testing set (n = 44) and a separate validation set (n = 24). We developed globalized (population) regression models to estimate VO₂ from the SCG and ECG signals measured continuously with the patch. We further classified the patients as stage D or C using the SCG and ECG features to assess the ability to detect clinical state from the wearable patch measurements alone. We developed the regression and classification model with cross-validation on the training-testing set and validated the models on the validation set. The regression model to estimate VO₂ from the wearable features yielded a moderate correlation (R² of 0.64) with a root mean square error of 2.51 ± 1.12 mL · kg^-1 · min^-1 on the training-testing set, whereas R² and root mean square error on the validation set were 0.76 and 2.28 ± 0.93 mL · kg^-1 · min^-1, respectively. Furthermore, the classification of clinical state yielded accuracy, sensitivity, specificity, and an area under the receiver operating characteristic curve values of 0.84, 0.91, 0.64, and 0.74, respectively, for the training-testing set, and 0.83, 0.86, 0.67, and 0.92, respectively, for the validation set.

Conclusions

Wearable SCG and ECG can assess CPX VO₂ and thereby classify clinical status for patients with HF. These methods may provide value in the risk stratification of patients with HF by tracking cardiopulmonary parameters and clinical status outside of specialized settings, potentially allowing for more frequent assessments to be performed during longitudinal monitoring and treatment.