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

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

Abstract
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

Abstract
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.

Development of a Novel Catheter-Deployed Cavopulmonary Support Device for Management of Single Ventricle Physiologies Associated with the Fontan Procedure

PIs: Omar Benavides, PhD and Jason Heuring, PhD
AFFILIATION Procyrion, Inc.
Award: $50,000

Abstract
Each year, approximately 4,000 infants are born in the United States with congenital heart defects that result in a single ventricle physiology. The Fontan repair is a palliative procedure that provides a reliable source of neonatal pulmonary blood flow at the expense of a sub-pulmonary ventricle. This results in chronic elevation in systemic venous pressure, reduction in ventricular pre-load, and subnormal cardiac output for the duration of life. In the more severe “Fontan failure” cases, patients exhibit classic features of congestive heart failure and eventually require a heart transplant. Recent literature suggested modest augmentation of cavopulmonary flow would reduce systemic venous pressure and increase ventricular filling, substantially improving cardiac output; however, current ventricular assist devices are primarily meant for systemic support and cannot address the issues specific to Fontan physiology. To overcome these limitations, Procyrion is developing a long-term, catheter-deployed mechanical circulatory support system that is implanted in the cavopulmonary connection to act as a primer for the single ventricle system. Procyrion’s current pre-clinical ventricular assist device, designated Aortix, addresses adult heart failure and has been successfully tested in a mock circulatory flow loop and in porcine, bovine, and ovine acute and chronic heart failure models (n=12) demonstrating proof of cardiovascular support and end-organ perfusion. The Aortix device decreases cardiac afterload and aortic root pressure and increases downstream (renal) perfusion and pressure. The objective of this proposal is to complete production and perform acute animal testing of a modified Aortix prototype that is tailored to specifically address the failing Fontan physiology. Consideration will be taken to address the unique geometry of the cavopulmonary junction, modify the mock circulatory flow loop to mimic the appropriate Fontan physiology, and validate the hemodynamic effects of the redesigned pump both in vitro and in an ovine model in vivo. With our Aortix-Fontan device positioned in the super and inferior vena cava, we expect to correct both venous congestion and pulmonary hypoperfusion, which should lead to a significant reduction in end-organ dysfunction and the need for cardiac transplant. Our long-term goal is to place Aortix-Fontan into clinical practice for treatment of failing Fontan physiology, decreasing patient dependence on hospital care and restoring their quality of life. This proposal combines the strengths of Procyrion – engineering and innovative product development – with those of the Texas Heart Institute Cardiovascular Research Labs – a GLP facility with internationally-recognized clinical and biomedical engineering investigators.

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

Abstract
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

Abstract
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.