The first reason of death of population under 45 years in developed countries is head trauma. Each year, over 3 million patients in Europe and North America have a traumatic brain injury (TBI) which places them at risk of brain damage and death from swelling of brain tissue. Monitoring intracranial pressure is vital to detect and control this swelling.
Currently ICP can only be measured using an invasive surgical procedure, in which a clinician drills a hole in the patient’s skull and inserts a probe into the brain. The cost, complexity and risks involved mean that ICP is measured only in the most critically ill patients and not in the millions of patients who are at mild to moderate risk. The procedure requires specialized neurosurgeon to place the catheter inside the patient’s skull that exposes the patients to the risk of infection, bleeding, and leak of fluids or loss of other body tissue, pain, and hyperthermia as well as risks related to anaesthetics. Relative to these risks and complexity of the procedure, only 20% of all TBI patients get access to the diagnostics of ICP, leaving out 1,280,000 TBI patients without proper examination of their brain injuries in Europe yearly. The lack of early diagnosis of increased ICP causes 100,000 new long-term disabilities and 400,000 deaths each year for these patients. Early diagnosis of mild and moderate TBI also requires non-invasive absolute ICP value measurement.
Innovative BrainSafe non-invasive ICP monitor addresses this need. It will offer a fast, safe, and easy-to-use method of regularly ICP measurement. The device based on ultrasound technology is being designed to measure ICP directly and non-invasively, using the same pressure balance principle as the standard blood pressure measurement.
Non-invasive technology will allow improvements in the current management of invasive ICP monitoring and the expansion of ICP measurements to a much wider group of patients, conditions and clinical settings.
The BrainSafe II concept is initiated by the SME Vittamed who has background knowledge and holds all background IPR of the proposed technological concept. The R&D will be completed by a consortium of experts within ultrasonic techniques, signal processing, microdrivers and ergonomic hardware design to ensure full safety and comfort to patients and ease of use and time saving for medical personnel. The RTOs are Kaunas University of Technology in Kaunas, Lithuania and Estonia Innovation Institute. The SME partners joining Vittamed form a coherent supply chain with the skills to manufacture and distribute the final product. The SMEs are Microplast, for high precision plastics moulding, Medelkom for its expertise with ultrasound transducers, Singer Instruments for electromechanical micro drivers and Vittamed for signal processing software.