SPHERA PRO

HYDROCEPHALUS PROGRAMMABLE SHUNT SYSTEM

Precision Adjustment – 08 Pressure Range

Security Against Deprogramming – MRI 3T

Hyperdrainage Prevention – Sphera Grav

Sphera Pro is a cerebral shunt system for intraventricular pressure control with a programmable valve. This product has been developed to provide ACCURACY on pressure control, SECURITY against deprogramming and EASY ADJUSTMENT procedure.

The valve has 08 different pressure settings, and pressure adjustment can be performed whenever necessary by a non-invasive device and painless to patients. Safety against magnetic fields deprogramming is provided by an exclusive double locking system, which holds the valve at the chosen pressure even when the patient undergoes MR examinations of up to 3 teslas.

The Sphera Pro system can be supplied along with the Sphera Grav antigravity device which acts in intraventricular pressure control when the patient changes from the horizontal to the vertical position, preventing overdrainage especially for patients with Normal Pressure Hydrocephalus (NPH).

The valve and reservoir are made of polysulfone with a silicone coating and titanium connectors. The system’s ventricular and peritoneal catheter are made of transparent silicone with a radiopaque fillet which enables the visualization in imaging tests and minimizes the occurrence of calcification in its path.

Especification

COMPONENTS

1. – Connectors, titanium

2. – Reservoir for puncture with rigid base

3. – Adjusting rotor with variable radius

4. – Antigravity device with tungsten balls

5. – Sphera pressure control mechanism (conical seat, spring and ruby ball)

6. – Double locking system with neodymium magnets and springs

7. – Silicone valve cover

ACCURACY WITH THE ADJUSTMENT MECHANISM

During the adjustment, the rotor movement changes the distance between the rotor axis and the Sphera mechanism (spring, sphera and conical ruby seat), increasing or decreasing the valve pressure. The precise rotor radius dimensional control allows the accurate definition of the 08 different levels of opening and closing pressures, providing a real intracranial pressure control when the pressure adjustment is performed.

SECURITY AGAINST DEPROGRAMMING

With a unique design, the valve rotor has two mechanical safety locks that move in opposite directions and may have double or single locking against non-intentional deprogramming. Each lock is located on a magnet and is pushed against a pressure position by the action of a spring.

When the magnetic fields from the environment, or an unilateral one (generated by MRI), are able to move one of the magnets and release one of the latches, the other is forced by the same fields to remain in the locking position, avoiding deprogramming of the valve.

ANTIGRAVITY DEVICE

Hiperdrainage control

The antigravity device Sphera Grav provides overdrainage control by performing automatic compensation for the system’s opening pressure as the patient postural changes.

When the patient is in the supine position, no resistance will be built by Sphera Grav, only the Sphera Pro valve will be active.

However, when the patient is in the orthostatic position, the maximum resistance of Sphera Grav will act along with the Sphera Pro adjustment pressure, making the shunt system more physiological and maintaining the intraventricular pressure more constant and with fewer risks of overdrainage.

Sphera Grav has 06 resistance options (10, 15, 20, 25, 30 or 35 cmH2O) to meet the different needs of pressure control for each patient. The device consists of tungsten and ruby spheres, polysulphone body, titanium connectors, and silicone coating.

EASY PRESSURE ADJUSTMENT

The programming device allows an easy pressure adjustment as it provides easy valve location, painless to the patient and immediate confirmation of the adjusted pressure, eliminating the necessity of image exams.

Since the correct programming device centralization upon the valve is essential to the unlocking and pressure adjustment, the reader has an indication alignment system that confirms the right position.

STEP 01

Set whether to reduce or increase the pressure by turning the top of the programmer counterclockwise or clockwise, until the indicator pin is in the “-” or “+” position.

STEP 02

STEP 03

Models

SPHERA PRO

Code	Content	Image
PRO10215	01 Hydrocephalus valve Sphera Pro 01 Cerebral ventricular straight catheter of 15 cm with stainless steel stylet and angular 01 Peritoneal catheter of 102 cm
PRO12015	01 Hydrocephalus valve Sphera Pro 01 Cerebral ventricular straight catheter of 15 cm with stainless steel stylet and angular 01 Peritoneal catheter of 120 cm
PRO10223	01 Hydrocephalus valve Sphera Pro 01 Cerebral ventricular straight catheter of 23.5 cm with stainless steel stylet and angular 01 Peritoneal catheter of 102 cm
PRO12023	01 Hydrocephalus valve Sphera Pro 01 Cerebral ventricular straight catheter of 23.5 cm with stainless steel stylet and angular 01 Peritoneal catheter of 120 cm
PRO10215R*	01 Hydrocephalus valve Sphera Pro with reservoir 01 Cerebral ventricular straight catheter of 15 cm with stainless steel stylet and angular 01 Peritoneal catheter of 102 cm 01 Test tube with adapter
PRO12015R*	01 Hydrocephalus valve Sphera Pro with reservoir 01 Cerebral ventricular straight catheter of 15 cm with stainless steel stylet and angular 01 Peritoneal catheter of 120 cm 01 Test tube with adapter

SPHERA PRO UNISHUNT

Code	Content	Conteúdo
UPRO10215	01 Hydrocephalus valve Sphera Pro 01 Cerebral ventricular straight catheter of 15 cm with stainless steel stylet and angular 01 Peritoneal catheter pre-attached to the valve with catheter of 102 cm
UPRO12015	01 Hydrocephalus valve Sphera Pro 01 Cerebral ventricular straight catheter of 15 cm with stainless steel stylet and angular 01 Peritoneal catheter pre-attached to the valve with catheter of 120 cm
UPRO10223	01 Hydrocephalus valve Sphera Pro 01 Cerebral ventricular straight catheter of 23.5 cm with stainless steel stylet and angular 01 Peritoneal catheter pre-attached to the valve with catheter of 102 cm
UPRO12023	01 Hydrocephalus valve Sphera Pro 01 Cerebral ventricular straight catheter of 23.5 cm with stainless steel stylet and angular 01 Peritoneal catheter pre-attached to the valve with catheter of 120 cm
UPRO10215R*	01 Hydrocephalus valve Sphera Pro pre-assembled to the valve; 01 Cerebral ventricular straight catheter of 15 cm with stainless steel stylet and angular 01 Peritoneal catheter pre-attached to the valve with catheter of 102 cm
UPRO12015R*	01 Hydrocephalus valve Sphera Pro pre-assembled to the valve; 01 Cerebral ventricular straight catheter of 23.5 cm with stainless steel stylet and angular 01 Peritoneal catheter pre-attached to the valve with catheter of 102 cm
UPRO10223R*	01 Hydrocephalus valve Sphera Pro pre-assembled to the valve; 01 Cerebral ventricular straight catheter of 23.5 cm with stainless steel stylet and angular 01 Peritoneal catheter pre-attached to the valve with catheter of 102 cm

 

 

SPHERA GRAV

SPHERA GRAV
Code	SPHERAGRAV-10
Content	01 Antigravity device with equivalent resistance to pressure of 10cmH2O
Code	SPHERAGRAV-15
Content	01 Antigravity device with equivalent resistance to pressure of 15cmH2O
Code	SPHERAGRAV-20
Content	01 Antigravity device with equivalent resistance to pressure of 20cmH2O
Code	SPHERAGRAV-25
Content	01 Antigravity device with equivalent resistance to pressure of 25cmH2O
Code	SPHERAGRAV-30
Content	01 Antigravity device with equivalent resistance to pressure of 30cmH2O
Code	SPHERAGRAV-35
Content	01 Antigravity device with equivalent resistance to pressure of 35cmH2O

Peritoneal Catheter

 

Catalog No.	Length (mm)	Ø Internal (mm)	Ø External (mm)	Functional Length (mm)
PA90	900	1.2	2.6	–
PA102	1020	1.2	2.6	–
PA120	1200	1.2	2.6	–

Ventricular Cerebral Catheter

Catalog No.	Length (mm)	Ø Internal (mm)	Ø External (mm)	Functional Length (mm)
VA15	150	1.4	2.7	23.5 mm ± 0.5 mm
VA23.5	235	1.4	2.7	23.5 mm ± 0.5 mm