SBIR-STTR Award

Vivonics is proposing a novel approach to address the needs of a non-invasive and real-time system to measure intracranial pressure (ICP) to support development of medical countermeasures. The proposed Intracranial Pressure Assessment and Screening System for Viral or Bacterial Infections (IPASS-VBI) leverages Vivonics expertise in non-invasively assessing ICP in humans due to traumatic brain injuries (TBI) by means of non-invasive optical-based technologies. The proposed system is based on our ongoing development of an ICP monitor (IPASS), which uses non-invasive estimates of ICP ranges, for medics and clinicians to screen and monitor ICP changes and fluctuations in time. The proposed IPASS-VBI is based on non-invasive near-infrared (NIR) measurements, which allows for a fast and easy assessment of ICP changes. Unique among the various approaches to non-invasive ICP measurement currently under development, the IPASS-VBI requires only two body-surface mounted sensors (typically located on the ear lobe and forehead) to provide continuous readings from a portable device. The IPASS-VBI system will be designed and engineered to be easy to use and provide reliable and real-time readings of ICP changes.

Pathogens reach the subarachnoid space (SAS) through the blood-stream, or from contiguous sites, and penetrate the blood-brain barrier though complex molecular and cellular mechanisms [1, 2]. For example, meningitis causes an imbalance between the water content of the brain parenchyma, CSF volume and cerebral blood flow thus resulting in a net increase of ICP [3]. Cerebral edema caused by inflammation and arterial dilation due to loss of autoregulation and CSF outflow impairment in the SAS are all integral factors in meningitis associated with intracranial hypertension. Because of the established association between infections involving the CNS (central nervous system) and increased ICP, it is crucial to monitor ICP when managing and treating infections of CNS [4]. Vivonics is proposing a novel approach to address the needs of a non-invasive and real-time system to measure ICP to support development of medical countermeasures. Our approach is based on the implementation of a proven technique [5], as demonstrated by Dr. Pierro (PI of this effort). The proposed Intracranial Pressure Assessment and Screening System for Viral or Bacterial Infections (IPASS-VorBI) leverages Vivonics expertise in non-invasively assessing ICP in humans due to traumatic brain injuries (TBI) by means of non-invasive optical-based technologies. Specifically, the IPASS-VorBI system is based on non-invasive near-infrared (NIR) measurements, which allows for a continuous, fast and easy assessment of ICP changes. This system meets an unmet military and civilian need for a portable and easy to use non-invasive device capable of measuring ICP changes, resulting from infections of the CNS (Central Nervous System), to support development of medical countermeasures and to diagnose TBI (Traumatic Brain Injury). The system’s potential to promptly and continuously assess ICP changes in real-time will provide actionable objective information to manage the patient, and potentially avoid secondary brain damage thus reducing mortality and improving patients’ long term outcomes.