Refinement of non-invasive approach to the determination of intracranial pressure

Period of Performance: 09/30/2007 - 09/29/2009

$531K

Phase 2 STTR

Recipient Firm

Allez Physionix, LTD
Seattle, WA 98102
Principal Investigator

Abstract

DESCRIPTION (provided by applicant): Elevated intracranial pressure (ICP) is associated with a number of serious neurological conditions. Its successful management yields improved outcome for patients, yet ICP can only be measured by placing a device within the cranium through a hole in the skull (yielding invasive ICP, or ilCP), a procedure associated with significant risks and requiring a neurosurgeon for its implementation. A non-invasive and easy method of measuring ICP (nICP) could be extremely useful for rapidly diagnosing neurological problems associated with high ICP. In our preliminary studies, we have designed a methodology to determine nICP and assembled a pre-prototype device that allowed us to collect the data necessary to implement this methodology during post-hoc analysis. Among other variables, this approach uses arterial blood pressure (ABP) measured invasively. We have built a series of nICP algorithms and successfully tested them on up to 21 patients whose mean ilCP ranged between 5-50 mmHg. Also, we have built and tested a prototype device that both facilitates the real-time comparison of nICP with ilCP and allows the storage of patient data for further nICP algorithm refinement. Moreover, our preliminary analysis shows that this approach is amenable to implementation with non-invasive ABP. The purpose of the present proposal is to refine this approach to nICP to the point that it can be favorably compared to ilCP, whether using invasive or non-invasive ABP.