SynCath

The Need

Neurosurgical injuries in general, and traumatic head injuries particularly, usually happen surprisingly, at almost any age, as a result of a variety of events: from sports injuries, car or bicycle accidents, to stroke or violent events – all of which require urgent and effective medical care to lessen the possibility of irreversible damage to the brain and prevent loss of life. The brain damage caused by traumatic brain injury is irreversible and may damage the quality of life, creating a dependence on caregivers, at a heavy financial cost. Being given the right treatment, at the right moment, may prevent the loss of additional brain cells.

In traumatic head injury (TBI), subarachnoid hemorrhage (SAH) and bleeding due to hemorrhagic stroke and aneurysm (ICH), the result is a significant increase in intracranial pressure, as a result of edema in brain tissue. The increase in pressure causes blood vessels to partially collapse, leading to a significant decrease in blood flow to the brain, and the supply of oxygen to the brain tissue, accordingly.

The immediate form of treatment available today is limited in terms of how much and for how long it can actually help these patients. Current treatment includes Mannitol solution (polysaccharide) to extract fluids from the brain cells and so relieve some of the intracranial pressure, inserting intracerebral drainage into the brain for expelling fluids, and finally the removal of a large portion of the skull to allow brain tissue to expand and lower this pressure. Mannitol has a limited effect since along with the CSF fluid removal, other liquids are also drained from other body tissues, resulting in a decrease in general blood pressure, which leads to a decrease in the blood supply to the brain.

The catheter used currently may be useful, but it often gets blocked by blood clots or the collapse of the ventricles. Catheter insertion is a simple procedure performed by interns. But the removal of part of the skull, on the other hand, is a highly invasive and traumatic process, which is not always effective since the brain tissue has a limited ability to expand. The patient often remains this way for many months, until recovery and skull restoration. A possible indirect treatment is to raise systemic blood pressure to increase flow - but this method may cause injury to other organs such as the kidneys.

These treatments, use of catheter and the partial removal of the skull, are medical procedures which were invented more than a hundred years ago. The methods of treatment are still currently limited and so there is a great importance and a significant need for the development of new tools for treatment, in cases where significant impairment of brain functions or even death may occur.
 

The Solution

Monitoring intracranial pressure is a critical procedure in treating brain injuries, but the existing process does not allow the neurosurgeon to understand what is really going on inside the skull of the patient, as it's based only on general statistical data rather than on the individual patient. The problem is that for each patient the level of critical pressure, at which dramatic intervention is needed, is different. This is where SynCath's innovative Tulip™ device comes into play, providing neurosurgeons with an innovative and effective tool for assessing the exact condition of each and every patient.

The critical parameter which the device measures, which is not available to neurosurgeons yet, is the intracranial elasticity, and it estimates the amount of fluid that can still accumulate in the brain before high pressure breaks the brain tissue (herniation) and causes severe damage. Another result of the intracranial pressure is also a partial collapse of blood vessels - SynCath's tech addresses this issue as well, as it includes the ability to also assess the blood flow in the brain.

The same device, when operated in a different mode, acts as an ingenious pressure regulator, augmenting blood flow in the brain and increasing oxygen supply to brain cells, thereby reducing the death of brain cells.
 

How does it work?

A catheter with a balloon at its tip, integrated with the commonly used drain, is inserted into a brain cavity in the same manner as drains are inserted. It is momentarily inflated by 1-2 ml at a specific time in the cardiac cycle. For the monitoring application, this perturbation is performed once every ten minutes. When operated as a pressure regulator, it is inflated momentarily at each cardiac cycle.

The two monitored parameters are estimated based on active monitoring, as opposed to conventional passive monitoring using a sensor - such as in a Manometer. In active monitoring, on the other hand, a deliberate and specific perturbation is caused and the patient's response to it is measured - which allows for the intracranial elasticity and blood flow to the brain parameters to be calculated.

In the treatment mode of operation the balloon is inflated in optimal timing, relative to the cardiac cycle, once in each cycle. The action of rapid filling and emptying at the right timing produces the action of a pressure regulator, which increases the blood flow in the brain and also the supply of oxygen to brain cells, to keep them alive. The company intends to expand this technology through further development to allow the use of a balloon to modulate the intracranial pressure, in a way that will increase the outflow of fluid through the draining catheter.

The Tulip™ device, the revolutionary solution offered by SynCath, will include the current treatment option, in the form of intracranial catheter, with the critical addition of the pressure measurement sensor - providing doctors with a full toolset to finally allow access to all currently available monitoring and treatment capabilities, topped off with SynCath's innovative monitoring and treatment capabilities.

Following discussions and consultations the company has held so far with well-known opinion leaders in the neurosurgical field, experts from around the world have stated their interest in using the company's tech in treating their patients.

The company's tech is divided into advanced treatment and diagnostic products:
 

Diagnostic (first commercial stage)

• Intracranial elasticity monitoring to assess the severity of edema and predict upcoming pressure crisis (proven in pre-clinical trials and published in the leading scientific journal in this field)
• Brain blood flow monitoring (in advanced development)

Therapeutic (second commercial phase)

• Inflatable-balloon pressure regulator for increasing the blood flow and oxidation of tissues in the brain (proven in pre-clinical trials, published in the leading scientific journal in the field)
• Controlled active catheter (in development)

Treatment of ischemic stroke

• Insertion of a catheter through a large vein and operating it as a pressure regulator to increase collateral blood flow in an obstructive stroke (future development)