Existing vital sign monitoring systems in the neonatal intensive care unit (NICU) require multiple wires connected to rigid sensors with strongly adherent interfaces to the skin. We introduce a pair of ultrathin, soft, skin-like electronic devices whose coordinated, wireless operation reproduces the functionality of these traditional technologies but bypasses their intrinsic limitations. The enabling advances in engineering science include designs that support wireless, battery-free operation; real-time, in-sensor data analytics; time-synchronized, continuous data streaming; soft mechanics and gentle adhesive interfaces to the skin; and compatibility with visual inspection and with medical imaging techniques used in the NICU. Preliminary studies on neonates admitted to operating NICUs demonstrate performance comparable to the most advanced clinical-standard monitoring systems.
Summary Paragraph The fast-growing field of bioelectronic medicine aims to develop engineered systems that relieve clinical conditions through stimulation of the peripheral nervous system (PNS) 1 – 5 . Technologies of this type rely largely on electrical stimulation to provide neuromodulation of organ function or pain. One example is sacral nerve stimulation to treat overactive bladder, urinary incontinence and interstitial cystitis/bladder pain syndrome 4 , 6 , 7 . Conventional, continuous stimulation protocols, however, cause discomfort and pain, particularly when treating symptoms that can be intermittent in nature (e.g. sudden urinary urgency) 8 . Direct physical coupling of electrodes to the nerve can lead to injury and inflammation 9 – 11 . Furthermore, typical therapeutic stimulators target large nerve bundles that innervate multiple structures, resulting in a lack of organ specificity. This paper introduces a miniaturized bio-optoelectronic implant that avoids these limitations, via the use of (1) an optical stimulation interface that exploits microscale inorganic light emitting diodes (μ-ILEDs) to activate opsins, (2) a soft, precision biophysical sensor system that allows continuous measurements of organ function, and (3) a control module and data analytics approach that allows coordinated, closed-loop operation of the system to eliminate pathological behaviors as they occur in real-time. In an example reported here, a soft strain gauge yields real-time information on bladder function. Data analytics algorithms identify pathological behavior, and automated, closed-loop optogenetic neuromodulation of bladder sensory afferents normalize bladder function in the context of acute cystitis. This all-optical scheme for neuromodulation offers chronic stability and the potential for cell-type-specific stimulation.
Low modulus, compliant systems of sensors, circuits and radios designed to intimately interface with the soft tissues of the human body are of growing interest, due to their emerging applications in continuous, clinical-quality health monitors and advanced, bioelectronic therapeutics. Although recent research establishes various materials and mechanics concepts for such technologies, all existing approaches involve simple, two-dimensional (2D) layouts in the constituent micro-components and interconnects. Here we introduce concepts in three-dimensional (3D) architectures that bypass important engineering constraints and performance limitations set by traditional, 2D designs. Specifically, open-mesh, 3D interconnect networks of helical microcoils formed by deterministic compressive buckling establish the basis for systems that can offer exceptional low modulus, elastic mechanics, in compact geometries, with active components and sophisticated levels of functionality. Coupled mechanical and electrical design approaches enable layout optimization, assembly processes and encapsulation schemes to yield 3D configurations that satisfy requirements in demanding, complex systems, such as wireless, skin-compatible electronic sensors.
Standard of care management in neonatal and pediatric intensive care units (NICUs and PICUs) involve continuous monitoring of vital signs with hard-wired devices that adhere to the skin and, in certain instances, include catheter-loaded pressure sensors that insert into the arteries. These protocols involve risks for complications and impediments to clinical care and skin-to-skin contact between parent and child. Here we present a wireless, non-invasive technology that not only offers measurement equivalency to these management standards but also supports a range of important additional features (without limitations or shortcomings of existing approaches), supported by data from pilot clinical studies in the neonatal intensive care unit (NICU) and pediatric ICU (PICU). The combined capabilities of these platforms extend beyond clinical quality measurements of vital signs (heart rate, respiration rate, temperature and blood oxygenation) to include novel modalities for (1) tracking movements and changes in body orientation, (2) quantifying the physiological benefits of skin-to-skin care (e.g. Kangaroo care) for neonates, (3) capturing acoustic signatures of cardiac activity by directly measuring mechanical vibrations generated through the skin on the chest, (4) recording vocal biomarkers associated with tonality and temporal characteristics of crying impervious to confounding ambient noise, and (5) monitoring a reliable surrogate for systolic blood pressure. The results have potential to significantly enhance the quality of neonatal and pediatric critical care.In the United States, over 480,000 critically-ill infants and children enter intensive care units (ICUs) each year. Those less than one year of age suffer from the highest morbidity and mortality rates and therefore require the most intensive care 1,2 . These fragile patients include
Skin-mounted soft electronics incorporating high-bandwidth triaxial accelerometers can provide broad classes of physiologically relevant information, such as mechanoacoustic signatures of underlying body processes (such as those captured by a stethoscope) and precision kinematics of core body motions. Here, we describe a wireless device designed to be conformally placed on the suprasternal notch for the continuous measurement of mechanoacoustic signals, from subtle vibrations of the skin at accelerations of ~10 −3 m•s −2 to large motions of the entire body at ~10 m•s −2 , and at frequencies up to ~800 Hz. Because th measurements are a complex superposition of signals that arise from locomotion, body orientation, swallowing, respiration, cardiac activity, vocal-fold vibrations and other sources, we used frequency-domain analysis and machine learning to obtain, from human subjects during natural daily activities and exercise, real-time recordings of heart rate, respiration rate, energy intensity and other essential vital signs, as well as talking time and cadence, swallow counts and patterns, and other unconventional biomarkers. We also used the device in sleep laboratories, and validated the measurements via polysomnography. Natural processes of the human body yield a multitude of mechano-acoustic (MA) signals, many of which strongly attenuate at the skin-air interface 1-5. Motions with amplitudes and Lee et al.
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