Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 456.00K | Year: 2012
DESCRIPTION (provided by applicant): ISS Inc., in collaboration with Dr. Franceschini of the Massachusetts General Hospital and Dr. Yodh of the University of Pennsylvania, proposes to develop and construct the prototype of a novel instrument to monitor cerebral oxygen metabolism (CMRO2) that combines a frequency-domain near-infrared tissue oximeter (FDNIRS) and a diffusion correlation spectroscopy (DCS) device. Combining FDNIRS and DCS will enable us to measure cerebral hemoglobin oxygenation (SO2) and an index (BFi) of cerebral blood flow (CBF) to estimate CMRO2. Our clinical collaborators Dr. Ellen Grant of Children's Hospitals in Boston, and Dr. Daniel Licht of Children's Hospital of Philadelphia will advise us on optimizing the device for the neonatal ICU clinical setting. The ability to rapidly an accurately assess cerebral metabolism at bedside in neonates is critical to improving patient management in neonatology. Currently there is no bedside tool that can accurately screen for brain injury, monitor injury evolution or assess response to therapy. Head ultrasounds are notoriously insensitive and nonspecific, EEG serves a complementary role, and MRI is too expensive and time-consuming to be used for screening or monitoring, and involves unnecessary risksof destabilizing critically ill infants who must be transported to the MRI suite. Conventional NIRS oximetry has failed to become a routine clinical tool in neonatology due to the poor sensitivity of SO2 in detecting brain injury hours after the insult,when equilibrium between oxygen delivery and consumption is reestablished. The direct measure of cerebral oxygen utilization we propose to measure with this novel instrument will provide higher sensitivity to detect brain injury and the ability to monitornormal and abnormal brain development. If successful, this device will allow for real-time interventions and thus could improve clinical outcome. Our long-term plans encompass the commercialization of the first FDNIRS/DCS cerebral metabolism monitoring system. In phase I we will build the first commercial prototype, start to develop unified acquisition and data analysis software, and test this new system in phantoms and adult human subjects. We will then perform a pilot study in newborns and compare infantswith seizure activity confirmed by EEG with healthy controls, to validate the hypothesis that a measure of oxygen consumption is better able to diagnose brain damage than measure of hemoglobin oxygenation. While CMRO2 monitoring has been performed previously in a research setting, by combining ISS FDNIRS systems with lab-built DCS instrumentation, these measurements have required highly trained operators and data analysis by optical imaging experts. Our goal is to transform these cumbersome research systems into a more robust turnkey device that will enable medical staff to obtain clinically and relevant measurements at the bedside. After completion of the Phase I portion of the project, we will proceed with Phase II, during which we plan to refine the system and start demonstrating the clinical relevance of our CMRO2 measurements in three hospitals (Brigham and Women's and Children's Hospitals in Boston, and Children's Hospital of Philadelphia with Dr. Daniel Licht). If the plan is accepted in its entirety,we expect to complete development of the FDNIRS/DCS system, which we call MetaOx, within the projected four-year period. PUBLIC HEALTH RELEVANCE: Newborn brain injury causes significant morbidity. The lack of a bedside monitor for newborn brain health is hindering progress in care that could improve neurodevelopmental outcomes. The overall goal of this SBIR is to develop an instrument with which to quantify cerebral oxygen metabolism in at the bedside to be used in neonatal intensive care units. Such a device will have significant clinical utility for assessing cerebral tissue injuy and disease, and to follow response to treatment.
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 0.00 | Year: 2003
DESCRIPTION (provided by applicant): Our goals in Phase I have been completed and showed the feasibility of our approach. We applied Near-Infrared Spectroscopy (NIRS), a non-invasive method and an affordable, portable, bedside technique for the diagnosis of the degree of the hypoxic insult in the brain, in sleep apnea, during daytime napping. It has been suggested that chronic, recurrent hypoxia during sleep leads to brain injury, which causes neuropsychological deficits and decline of cognitive function. Cerebrovascular accidents, including fatal strokes are not uncommon. Conventional polysomnography, a relatively expensive test, detects sleep apnea at various sleep stages and determines arterial oxygen saturation. However, current clinical methods do not provide information on brain oxygenation, which is important especially in subjects with preexisting anatomical or functional vascular pathology. NIRS enables continuous real-time measurements of changes in the hemoglobin oxygenation and blood volume, thus providing information on tissue oxygenation and hemodynamics. In Phase II we propose the development of a tool and the application of NIRS to determine cerebral hemodynamics during sleep, in association to overnight polysomnographic sleep studies. Our goal is the development of reliable, cost efficient instrumentation for early detection of cerebral hemodynamic abnormalities in sleep apnea, for the prevention of hypoxic cerebral morbidity and mortality.
Agency: Department of Defense | Branch: Army | Program: SBIR | Phase: Phase I | Award Amount: 70.00K | Year: 2008
The early recognition of severe hemorrhage is a key factor towards reducing mortality and morbidity from battlefield insults. Although near-infrared (NIR) instruments have shown promise in recognizing hemorrhage, specific confounding factors must be solved to be reliable in early hemorrhage. Our hypothesis is that these confounding factors can be eliminated by proper light-tissue interaction modeling (frequency-domain photon migration), and by increasing spectral (1000 wavelengths) and temporal (200 ms) bandwidth. The objective of this proposal is to provide a compact point-of-care NIR instrument that is capable of quantitatively detecting early hemorrhage and monitoring therapeutic interventions. Our proposal features collaboration between (1) a leading biomedical technology company (ISS, Inc., Champaign, IL) that produces state-of-the-art NIR tissue oximeters, operates production facilities and has FDA submission experience, and (2) a university research team (Beckman Laser Institute, UC Irvine), with tissue optics experts who have experience in the assessment of traumatic injury via NIR optical methods. The existing ISS oximeter will be modified to increase information content that will solve the confounding factors. At the conclusion of Phase I, we will provide a unique NIR instrument that will be available for comprehensive validation and optimization studies (Phase II) and subsequent commercial miniaturization (Phase III).
Agency: Department of Defense | Branch: Army | Program: SBIR | Phase: Phase II | Award Amount: 779.72K | Year: 2009
The early recognition of severe hemorrhage is a key factor towards reducing mortality and morbidity from battlefield insults. Although near-infrared (NIR) instruments have shown promise in recognizing hemorrhage, specific confounding factors must be solved to be reliable in early hemorrhage shock detection. Our hypothesis is that confounding factors can be reduced or eliminated by i) using increased spectral and temporal information, ii) using a real-time statistical algorithm to measure the hemodynamic/cardiac behavior. The objective of this proposal is to provide a compact point-of-care NIR instrument that is capable of quantitatively detecting early hemorrhage and monitoring therapeutic interventions. Our proposal features collaboration between (1) a leading biomedical technology company (ISS, Inc., Champaign, IL) that produces state-of-the-art NIR tissue oximeters, and (2) a university research teams at UC Irvine, with tissue optics experts who have experience in the assessment of traumatic injury via NIR optical methods. The existing ISS oximeter will be modified to increase information content that will solve the confounding factors. At the conclusion of Phase I, we will provide a unique NIR instrument that will be available for comprehensive clinical validation and subsequent commercialization (Phase III).
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 179.98K | Year: 2009
DESCRIPTION (provided by applicant): Abstract ISS Inc. proposes to develop a novel non invasive instrument for quantitative monitoring of infant brain development. The instrument will be based on Frequency Domain Near-Infrared Spectroscopy technique and will feature eight (8) laser sources modulated simultaneously using the OFDM technology. The laser sources will emit at different wavelength. The new instrument will be portable, safe, inexpensive and accurate; it will measure absolute, quantitative, region specific values of hemodynamic parameters such as Cerebral Blood Volume and Oxygen Consumption. This instrument can be used with conscious infants during first year of life, giving a tool to monitor the assessment of infant brain development. The Phase I portion of the project will have two parts: During the first part we will design and construct ten (10) new arbitrary RF synthesizers for simultaneous multiplexing the laser sources using OFDM technology; each module will include a Digital-To- Analog Converter (DAC) and a Field Programmable Gate Array (FPGA) chip, in addition to associated clocking circuitry; we will develop the software to demultiplex the signal and analysis tool to recover absolute hemodynamic values. Finally, we will integrate the new electronics into the existing instrument. During the second part we will validate the prototype measuring on phantoms. PUBLIC HEALTH RELEVANCE: Project narrative We propose to build a bedside oximeter to measure brain oxygenation in conscious infants and neonates. The instrument will be non-invasive and will use non ionizing radiation. It will be a particularly useful tool for clinicians for monitoring cerebral oxygenation to better understand the rate of cerebral growth and the development in the first year of life. The new instrument will be faster and more accurate than the existing instruments. The instrument will be portable and affordable and it will open the doors for the investigation and relevant medical applications in neonatology and pediatrics.