This Small Business Innovation Research (SBIR) Phase I project proposes to develop a noninvasive intracranial pressure (ICP) monitor based on a pilot clinical study correlating ocular blood pressure and blood flow parameters to ICP. The proposed novel device will combine several standard medical techniques used by ophthalmologists to gather data. The ultimate goal for this project is to develop a portable, easy-to-use unit that will be used by medical personnel on patients in the hospital and prior to their arrival.
The broader impacts/commercial potential of this project are improving the diagnosis of elevated ICP and reducing the complications associated with unnecessary invasive procedures on patients with head injury. ICP monitoring is a common tool for physicians treating patients with acute intracranial hypertension caused by neurological disorders, trauma, and stroke. Knowledge of a patient's ICP progression aids the physician in determining the optimal medical and/or surgical treatment. Every year, these surgical procedures expose patients to significant complications. Commercialization of a noninvasive ICP monitor would significantly decrease the burden on patients and to the healthcare system in the diagnosis and treatment of head injury by determining ICP more cheaply and safely than current technologies. A non-invasive method would also address the need for additional long term ICP monitoring data and expand the knowledge of how mild or moderate traumatic brain injury relates to ICP.
This Small Business Innovation Research Phase I project involved the development of a noninvasive intracranial pressure monitor. This project demonstrated the feasibility of the device design. Using the device developed in this Phase I project, noninvasive ICP data will be collected in a Phase II human clinical trial that will demonstrate efficacy by comparing the non-invasive measurements to gold standard invasive ICP monitoring. The ultimate goal for this project is to develop a portable, easy-to-use unit that will be used by medical personnel on patients in the hospital and prior to their arrival. ICP monitoring is a common tool for physicians treating patients with acute intracranial hypertension caused by neurological disorders, trauma, and stroke. Knowledge of a patient’s ICP progression aids the physician in determining the optimal medical and/or surgical treatment. Every year, these surgical procedures expose patients to significant complications. Commercialization of a noninvasive ICP monitor would significantly decrease the burden on patients and to the healthcare system in the diagnosis and treatment of head injury by determining ICP more cheaply and safely than current technologies. A non-invasive method would also address the need for additional long term ICP monitoring data and expand the knowledge of how mild or moderate traumatic brain injury relates to ICP. There is currently no commercially available device that can accurately measure intracranial pressure noninvasively. A recent market analysis based on a reasonable unit price of $20,000 estimates the total potential United States market for a non-invasive device to be $1.3 billion, which includes intensive care units, emergency rooms, ambulances, air medical transport aircraft, general practice physicians, and internists.
