Funded Projects 2014

Non-Invasive Intracranial Pressure (ICP) Meter Head Frame Modification for Children

PI: Remis Bistras, PhD, MBA
AFFILIATION Vittamed Corporation
Award: $50,000

Medical need exist for accurate non-invasive Intracranial Pressure measurement for multiple groups of pediatric patients, such as hydrocephalus, kids with traumatic brain injuries, Pseudotumor cerebri and others. They all could benefit from ICP measurements and management but currently only invasive methods are available, which require placing intraventricular catheter for Hydrocephalus or TBI patients or lumbar puncture for neurological patients.

Vittamed has developed non-invasive ICP meter which is using safe ultrasound technology and measures ICP by using blood flow parameters in two pieces of ophthalmic artery: intracranial and extracranial.

The non-invasive ICP meter has been validated in clinical studies for adult population (18 years and older) conducted at several European sites (Publication in Neurology, 2013 and others). Clinical studies have found that there is a high correlation between ICP measurements taken by our device and the current gold standard invasive techniques (standard deviation only 2.3 mmHg with a very high precision vs lumbar puncture or intraventricular catheter). This is clinically a totally acceptable standard deviation; typically invasive devices compare to one another with a SD >2-3 mmHg;

Clinical studies also found that ICP meter has a very good to excellent diagnostic value for patients with elevated ICP (> 15 mmHg); clinically tested: Specificity – up to 96%; Sensitivity – up to 84%; overall accuracy – up to 96%; (See publication in Neurology, 2013, Neurological Research 2014, and others). We would like to adopt this technology for pediatric patients (older than 8 years). For this we will need to redesign head frame used for ultrasonic measurement to fit comfortable children’s head; we also will design the head frame so that ultrasound transducers could insonate simultaneously two segments of ophthalmic artery (intracranial and extracranial) for children. The prototype will be produced and tested for comfort and functionality.

Development of Laser Speckle Contrast Imaging as a Non-Invasive Diagnostic for Retinopathy of Prematurity

PIs: Janet Alexander, MD and Jason Brooke, MSE, JD
AFFILIATIONS University of Maryland Baltimore and Vasoptic Medical, Inc.
Award: $50,000
One in nine children born in the US, or half a million babies per year, are born prematurely; worldwide, the number is estimated at 15 million. Babies born particularly early or at low birth weight are at high risk of blindness from a disease called Retinopathy of Prematurity, or ROP. ROP is one of the top three causes of childhood blindness in the world. Ophthalmologists diagnose and make decisions about the initial treatment of ROP based on the subjective appearance of the retinal blood vessels. Hence, there is a critical unmet need for a more accurate method of screening infants for ROP. An ideal system for diagnosis of ROP would have the ability to quantify the vascular abnormalities in a standardized, reproducible, and objective manner. Semi-automated methods are available to quantify the vascular morphologic changes seen in ROP; however, these technologies lack the ability to image and quantify with speed and reliability using a non-invasive tool. Vasoptic Medical Inc. has developed a handheld retinal imager and software algorithms for early detection of a variety of vision-threatening conditions. The device utilizes dual imaging techniques—fundus photography and laser speckle contrast imaging (LSCI)—to capture quantitative anatomical and physiological information from the microvasculature of the retina without the need for exogenous dyes. Funds from this award will be used to adapt this technology for imaging the retinae of infants to image and quantify ROP and to validate its feasibility in an animal model. The results of this work will facilitate clinical evaluation and marketing of a novel medical device for diagnosis of a condition that impacts all aspects of a child’s development and shapes the adult they become.

Imaging Through the Eardrum for Improved Diagnosis of Middle Ear Disease

PI: Ryan Shelton, PhD
AFFILIATION: PhotoniCare, Inc
Award: $50,000
Otolaryngologists and primary care physicians are responsible for diagnosing and treating the general population for ear disease, but they have limited tools with which to accomplish this. The current standard diagnostic tool for evaluating the middle ear, the otoscope, is a basic magnifier of tissue surfaces and has limited diagnostic ability and repeatability. The longterm goal of this work is to reduce healthcare costs and improve patient outcomes by giving physicians new imaging tools that, for the first time, allow them to see behind the eardrum in order to visualize an infection and take quantitative measurements of middle ear effusions and biofilms. Biofilms have been linked in literature to chronic ear infections that result in tube surgery. To date, the proposed technology is the only way by which biofilms in the middle ear can be identified and visualized non-invasively. This unprecedented view into the middle ear has the potential to fundamentally change the way middle ear disease is managed by providing quantitative indications for surgery and other advanced therapeutics. This project will focus on development of a commercial prototype and deployment of that prototype into Children’s National Medical Center for an exploratory study.

Magnetic System to Direct Therapy to Middle Ear Infections in Children

PIs: Benjamin Shapiro, PhD and Diego Preciado, MD, PhD
AFFILIATION Otomagnetics LLC and Children’s National Health System
Award: $50,000

Middle ear infections are the leading cause for pediatrician visits. In the US, there are an estimated 15 million cases/year of acute otitis media (AOM) in children ≤ 5 years old. Approximately 20% of these cases progress on to chronic otitis media with effusion (COME). COME is associated with hearing loss, delayed speech development, and increased incidence of permanent middle ear damage. Tube insertion through the ear drum (tympanostomy tube placement) for COME and recurrent AOM is the most common pediatric surgical procedure in the US, and requires general anesthesia with its attendant risks. There is no effective non-surgical treatment for COME or recurrent AOM.

At the University of Maryland, we have invented a system to magnetically deliver therapy to ear compartments. Our approach has the potential to improve both the treatment of AOM (by delivering drugs to just the middle ear instead of systemic administration) and COME (by eliminating/reducing the need for tubes).

Otomagnetics was formed in March 2012 to commercialize the technology. The company has already won non-dilutive grants from the State of Maryland (MIPS, TEDCO, BioMaryland), as well as a seed grant from Children’s/UMD. NCC-PDI funding is sought to move the technology from the laboratory towards FDA allowance and to clinical use.

Engineering Optimization of a Low-Cost Multifunctional Incubator

PI: Govind Rao, PhD
AFFILIATION University of Maryland Baltimore; Center for Advanced Sensor Technology
Award: $25,000
Every year, an unacceptably large number of infant deaths occur in developing nations, with premature birth and asphyxia being two of the leading causes. Compared to adults, newborns are particularly vulnerable to heat loss. Therefore, a well-regulated thermal environment is critical for neonatal survival. Advanced incubators currently exist, but they are far too expensive to meet the needs of developing nations. We are developing a thermodynamically advanced low-cost incubator suitable for operation in low-resource environment. Our design features 3 innovations: 1) a disposable baby chamber to reduce infant mortality due to nosocomial infections, 2) a passive cooling mechanism utilizing low cost heat pipes and evaporative cooling from locally found clay pots, and 3) insulated panels and a thermal bank consisting of water that effectively preserve and store heat, greatly reducing power. We developed a prototype incubator, visited, and presented our design to our partnership hospital site in Mysore, India. After obtaining feedback, we have determined realistic, non-trivial design requirements and constraints in order to develop a new prototype incubator for clinical trials in hospitals in India.