Sphera Pro is a brain shunt system for the control of intraventricular pressure with programmable valve. The product is designed to provide PRECISION in pressure control, SAFETY against deprogramming and EASE of pressure adjustment. The valve has 08 different pressures, and pressure adjustment can be performed whenever necessary by a non-invasive and painless magnetic device to the patient. The safety against deprogramming by actuation of external magnetic fields is provided by an exclusive double-locking system, which keeps the valve at the chosen pressure even when the patient is submitted to MRI scans of up to 3 teslas. The Sphera Pro system can be supplied in conjunction with the Sphera Grav antigravitational device, which acts to control intraventricular pressure when the patient changes from horizontal to vertical position, preventing hyperdrainage mainly in patients with Normal Pressure Hydrocephalus (NPH). The valve and reservoir are made of polysulphone with silicone coating and titanium connectors. The ventricular and peritoneal catheter of the system are transparent silicone with radiopaque fillet, which allows visualization in imaging tests and minimizes the occurrence of calcification in its path.
ACCURACY IN THE ADJUSTMENT MECHANISM
During adjustment, rotor movement changes the distance between the rotor shaft and the Sphera mechanism (spring, ball, and ruby conical accent), increasing or decreasing valve pressure. The rigorous dimensional control of the rotor radius allows you to precisely define the 08 different opening and closing pressures of the system, providing real control of intracranial pressure when pressure adjustment is performed.
SAFETY AGAINST DISPROGRAMMING
With a unique design, the valve rotor has two mechanical safety locks that move in opposite directions, being able to lock the system twice or individually against unintentional deprogramming. Each latch is located on one of the magnets and is driven against a pressure position by the action of a spring.
EASE OF PROGRAMMING
The programming device provides easy pressure adjustment, as it allows easy valve location, does not generate pain to the patient and allows immediate confirmation of the adjusted pressure, without the need for imaging. Because the correct centering of the programming device on the valve is essential for unlocking and adjusting the pressure, the reader has an alignment indication system that confirms the correct position.
The Sphera Grav antigravitational device provides control of hyperdrainage,as it automaticallycompensates the opening pressure of the system with the postural change of the patient. When the patient is lying down, no resistance will be generated by the Sphera Grav device,acting only on the Sphera Pro valve. However, when the patient is in an orthostatic position, the maximum resistance of Sphera Grav will act in addition to the adjustment pressure of sphera pro, making the shunt system more physiological, maintaining more stable intraventricular pressure and with lower risk of hyperdrainage. Sphera Grav has 06 resistance options (10, 15, 20, 25, 30 or 35 cmH2O) to meet the different pressure control needs of each patient. The device consists of tungsten and ruby spheres, polysulphone body,titanium connectors and silicone coating.
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