With the exception of the lumbar puncture, existing methods of measuring Intracranial Pressure (ICP) are relatively invasive. They require surgery (drilling a hole through the skull) and local or general anesthesia, and in many cases, implantation of a measuring device in the brain or its ventricles. Vittamed Neurosciences, in contrast, has developed a unique non-invasive method of measuring ICP that utilizes the ophthalmic artery as a natural ICP sensor and, unlike other non-invasive systems under development, does not require calibration or an external zero point. Other non-invasive systems are only capable of tracking ICP once a baseline has been developed.
Disadvantages of Invasive ICP Measurement:
- Indwelling device entail risks of infection, mal-positioning, malfunction, migration and hemorrhage, among others.
- Almost all require monitoring in a critical care unit.
- Lumbar subarachnoid catheters can sometimes substitute for long term ICP monitoring and sampling can substitute for lumbar puncture, but entail the same risks as other forms of invasive monitoring when used in this manner.
- Most systems require calibration.
- Drift and fouling are be problematic, particularly in those sensors that are pre-calibrated from the factory.
- Invasive methods are very risky and usually not utilized when patients are anticoagulated, as the often are in stroke.
Vittamed uses the ophthalmic artery (OA) as a natural ICP sensor. The OA is uniquely suited to this purpose because of its anatomical course.
The OA originates from the internal carotid artery inside the cranium, then traverses the optic canal with the optic nerve to enter the orbit where it supplies the optic nerve and the eye. It is subject to the ICP inside the cranium, but not in the orbit where the ambient pressure is equal to atmospheric pressure under normal circumstances.
The diameter of the OA inside the cranium is smaller than the orbit because of the influence of ICP. As a result, the blood flow velocity is higher intracranially than in the orbit. As pressure is added to the orbit, the diameter of the intraorbital segment of the OA diminishes, thereby elevating the blood flow velocity. Blood flow velocities in the distal and proximal (intracranial and intra-orbital) segments equilibrate when the external pressure added to the orbit approximates the ICP.
This point at which the external pressure added to the orbit equilibrates blood velocities in the intracranial and extracranial segment of the OA is called the balance point or equilibration point. The ICP can be derived from the amount of pressure required to reach the balance or equilibration point.
Because the OA is used as the ICP sensor, no external zero reference point is required. The use of the OA renders this method of ICP measurement entirely self-calibrating.
Blood flow velocities and other aspect of pulse dynamics are measured by means of image-guided transcranial and orbital Doppler ultrasound. Pressure is applied through the automated, computer-controlled inflation of an air cushion over the closed eye.
In practice, the patient is fitted with a frame similar to a swimming mask to which the ultrasound Doppler probe is fitted. The mask also contains a disposable inflatable air cushion.
Blood flow velocities in the proximal and distal OA are measured and displayed on a touchscreen-equipped computer. The automated, computer-controlled inflation module gently increases pressure in the air cushion stepwise until the balance point is reached. At that point, the ICP measuring device calculates the ICP and displays it on the screen.
Most of the process is automated. A number of additional controls are available for advanced clinical and research purposes.
A schematic of the noninvasive ICP measurement instrument
A special mask is positioned on the patient’s face. The mask holds an ultrasound transducer in contact with an inflatable cushion which is connected both to a computer regulated source of pressurized air. The air pump is used to increase the pressure against the closed eye. Simultaneously the ultrasound transducer measures compares the velocity of blood flow in the proximal and distal segments of the OA. The ICP is derived from the level of pressure required to equalize the pressure in the two segments.
Over 450 patients have been examined in the course of inpatient and outpatient mulitcenter trials in the EU and in the USA. There have been no adverse events.
- Accuracy (Systematic Bias) has of 0.5 mmHg
- Precision or Standard Deviation less than 2.5 mmHg
- Correlation with commercially available implanted monitoring devices R > 0.8
- Results statistically significant and clinically significant
- Results comparable to standard parenchymally implanted devices
ICP is the abbreviation for intracranial pressure, the pressure within the skull.
ICP was first measured in the late 19th century by puncturing the reservoir of cerebrospinal fluid (CSF) in the lumbar spine. This was called a lumbar puncture or spinal tap.
The CSF is made in the ventricles (chambers) of the brain and circulates through the central nervous system (CNS) in the subarachnoid space. The CSF in the spine normally communicates with the CSF in the brain.
When the subarachnoid space in the lumbar spine is punctured, the pressure can be measured by means of a manometer, a transparent calibrated tube calibrated in millimeters of water. The pressure is expressed in terms of the height of the column of CSF in mm H2O.
Pressure can also be measured by cannulating the ventricles of the brain. This procedure is more invasive than a lumbar puncture, but also often produces more accurate measurements. It also allows for calibrated external drainage of CSF from the ventricle to reduce ICP.
Historically the ventricular cannula was attached to a manometer in the same way as the lumbar puncture needle. Ventricular pressure was similarly expressed in mm H2O.
More recently, pressure sensors were designed to be implanted intraparenchymally, within the substance of the brain, to simplify the surgical procedure. No column of CSF was involved. Following the convention in blood pressure measurement, these sensors were calibrated in millimeters of mercury (mm Hg) rather than in mm H2O,. One mm Hg is equal to 13.6 mm H2O.
Normal CSF pressure is generally cited as approximately 60–250 mm H20 (95% confidence intervals) with a population mean of 180mm in the usual clinical setting. There is considerable variability around this range, however, and a good deal of clinical judgement may be required to assess what value is acceptable for any individual patient. Pressure values must be interpreted in light of the clinical setting (Lee SC, Lueck CJ. Cerebrospinal Fluid Pressure in Adults. J Neuroophthalmology 2014. Sep; 34(3):278-83).
Abnormalities of ICP can result from many neurological and neurosurgical conditions, including trauma, tumors, hemorrhage, stroke, hydrocephalus, congenital abnormalities, infection, and other sources of altered CSF or intracranial blood flow dynamics. Elevated ICP (intracranial hypertension) may compromise cerebral perfusion or blood flow when the ICP exceeds mean arterial blood pressure. At that point, the brain may be starved of blood (ischaemia) and oxygen (hypoxia), resulting in neurological dysfunction which can progress to brain damage, visual loss and death. Elevated ICP requires careful monitoring and may require urgent intervention. Low ICP (intracranial hypotension) may also be abnormal and may also require treatment.