TECH OFFER

Noninvasive Intracranial Pressure (ICP) Monitor

KEY INFORMATION

TECHNOLOGY CATEGORY:
Electronics - Sensors & Instrumentation
Healthcare - Diagnostics
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TECHNOLOGY READINESS LEVEL (TRL):
LOCATION:
United Kingdom
ID NUMBER:
TO100313

TECHNOLOGY OVERVIEW

Head injuries are a significant cause of injury and death, with approximately 50,000 cases of severe traumatic brain injury per year in the UK, the majority leading to death or severe disability. Cerebral damage sustained at the time of impact is referred to as primary injury and is irreversible and best treated by prevention (seatbelts, cycle helmets etc). Secondary brain injury occurs after the initial injury and is defined as damage arising from the body’s physiologic response to the primary injury. As the skull is a closed cavity containing water and other largely incompressible material, even minor swelling can cause significant increases in ICP (intracranial pressure). Various strategies exist to arrest or reverse the pressure in the brain due to head trauma, so monitoring the ICP is a vital tool in the management of severe head injuries.

A new non-invasive system for continuous monitoring of ICP via a forehead-mounted probe has been developed. Although the cranium is a closed rigid structure, interrogation using infrared light provides a potential ‘window’ for monitoring cerebral haemodynamics. The probe contains infrared light sources that can illuminate the deep brain tissue of the frontal lobe, while photodetectors in the probe detect the backscattered light, which is modulated by pulsation of the cerebral arteries. Changes in the pressure surrounding the cerebral arteries affect the morphology of the recorded optical pulse, so analysis of the acquired signal using an appropriate algorithm will enable calculation of non-invasive ICP (nICP) that can be displayed continuously to clinicians.

TECHNOLOGY FEATURES & SPECIFICATIONS

The 'gold standard' technique for ICP monitoring is a catheter inserted into the frontal horn lateral ventricle via a right frontal burr hole, connected to a pressure transducer via a fluid-filled catheter. It has the advantage of allowing therapeutic drainage of cerebrospinal fluid (CSF) and administration of drugs. However, insertion may be difficult if the ventricles are small and even if performed in a sterile environment, infections and bleeding are significant potential risks.

There has been much research in recent years to find a method for measuring intracranial pressure noninvasively (nICP) but none of these methods have found their way into clinical use as they all require considerable user interventions and are non-continuous or suffer from performance issues.

This is a new non-invasive approach for ICP monitoring that will reduce the the side effects of current invasive techniques and will allow rapid response and monitoring of ICP in a compact instrument that has hitherto not been possible.

The prototype is currently undergoing trials with a major London hospital under the supervision of a consultant neurosurgeon.  Over 20 patients have been included in the trial to date and more will be included in the current trial to bring the numbers up to 40+.  A poster of the recent work that has been undertaken is provided in the attached documentation along with data on performance.

Further developments are currently underway to improve performance of the instrument although discussions with clinical consultants indicates that the current performance is suitable for clinical use.

POTENTIAL APPLICATIONS

The technology allows rapid assessment of the patient’s condition noninvasively and this reduces the significant risk of side effects whilst reducing the cost of monitoring. This makes the technology advantageous in situations where conventional assessment of intracranial pressure may not be considered because of the invasive nature of the procedure. Therefore, this approach could become a standard procedure in all situations where concussion has occurred.  The device would be suitable for use in the pre-hospital environment, emergency departments and intensive care units.

In addition to the monitoring of Traumatic Brain Injuries in a conventional clinical setting, this device could also facilitate research and clinical monitoring in non-head injury medicine, such as liver failure, migraine, diabetes, anaesthesia, intensive care, renal medicine etc.

Aside from trauma, management of other conditions associated with intracranial hypertension such as hydrocephalus, severe migraine and meningitis, could benefit from nICP monitoring. In many cases, especially borderline cases or those in early stages, the risk of invasive ICP monitoring is not justifiable. Nevertheless, intracranial monitoring could provide invaluable clinical information. A non-invasive ICP monitor would also be an invaluable research tool both for investigation of pathophysiology and for assessment of the effectiveness of treatments for intracranial hypertension. There may also be opportunities for research into ICP responses at high altitudes or for space medicine applications. 

Market Trends & Opportunities

Currently there are no competitive nICP products in the market place that provide user friendly and gold standard performance in real time, the current invasive approach is the prime technique used for ICP monitoring. Given the ease of use of this new approach to nICP, it is estimated that the market opportunity is far larger than the use of current methods which are limited by the nature of an invasive procedure.  Discussions with consultants in a number of Brain Trauma units have indicated a strong market pull for an instrument that will obviate the need for an invasive ICP measurment in real time.

Indicators of market potential are provided in the attached poster.

Benefits

Lower costs, easier to use and applicable in almost all head trauma applications.

The reported nICP could provide invaluable screening at the triage stage, indicating intracranial hypertension which require imaging or interventions (such as CSF drainage). It could also provide effective guidance for head injury management, notably ICP-targeted treatment regimes. Ultimately this could lead to significant improvements in secondary injury-related mortality, length of hospital stay and reduced post-trauma disability. It could also be applied in causes of non-trauma related intracranial hypertension including meningitis, hepatic encephalopathy, hydrocephalus and severe migraine.

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