SPHERA PRO

HYDROCEPHALUS PROGRAMMABLE SHUNT SYSTEM

 
      Precision Adjustment – 08 Pressure Range
      Security Against Deprogramming – MRI 3T
      Hyperdrainage Prevention – Sphera Grav
Hpbio-Icone-Acrobat

 

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.



 



COMPONENTS

 
HpBio-SpheraPro-Componentes-2
 
      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
Sphera-Pro-Posicoes-En

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 moves 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.

 

Sphera-Pro-Seguranca-01
 
Rotor unlocked by the
programming device
Sphera-Pro-Seguranca-02
 
Rotor locked even with
one lock unlocked by the
action of the magnetic fields
Sphera-Pro-Seguranca-03
 
Rotor double locked by
the action of the springs

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 less 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.
Sphera-Pro-Antigravitacional-2
 
Sphera Grav-20 functioning on the postural change with the Sphera Pro adjusted in 10 cmH2O

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 aligment system that confirms the right position.
Sphera-Pro-Programador-En
Sphera-Pro-Programacao-Passo01-A
 
Sphera-Pro-Programacao-Passo01-B Out centered pointer:
programming device on
the incorrect position Sphera-Pro-Programacao-Passo01-C Centered pointer:
programming device on
the correct position

STEP 01



With the compass placed on the positioner, locate the valve.
Align the positioner flow indication arrow with the peritoneal catheter path.
By moving the positioner around the valve, align the center of the pointer with the center of the compass.
While moving the compass, in both directions, the pointer must remain still.
Perform the reading.

STEP 02

Sphera-Pro-Programacao-Passo02 Keep the positioner on the same site and insert the programmer on the place of the compass. Turn counterclockwise to increase the pressure and clockwise to decrease the pressure.

STEP 03

Sphera-Pro-Programacao-Passo03 Replace the programmer for the compass. Perform the reading of the new pressure, keeping the pointer center aligned with the center of the compass.

 

SPHERA PRO
Code
    PRO10215
Content
    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
Content
    Hpbio SpheraPro
Code
    PRO12015
Content
    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
Conteúdo
    Hpbio SpheraPro
Code
    PRO10223
Content
    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
Content
    Hpbio SpheraPro
Code
    PRO12023
Content
    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
Conteúdo
    Hpbio SpheraPro
SPHERA PRO UNISHUNT
Code
    UPRO10215
Content
    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
Conteúdo
    Hpbio SpheraPro Unishunt
Code
    UPRO12015
Content
    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
Conteúdo
    Hpbio SpheraPro Unishunt
Code
    UPRO10223
Content
    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
Conteúdo
    Hpbio SpheraPro Unishunt
Code
    UPRO12023
Content
    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
Conteúdo
    Hpbio SpheraPro Unishunt
SPHERA PRO UNITIZED
Code
    UNPRO10215
Content
    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
Conteúdo
    SpheraPro-Unitized
Code
    UNPRO12015
Content
    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
Conteúdo
    SpheraPro-Unitized
Code
    UNPRO10223
Content
    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
Conteúdo
    SpheraPro-Unitized
Code
    UNPRO12023
Content
    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
Conteúdo
    SpheraPro-Unitized
SPHERA GRAV
Code
    SPHERAGRAV-10
Content
    01 Antigravity device with equivalent resistance to pressure of 10cmH2O
Conteúdo
    Hpbio SpheraGrav
Code
    SPHERAGRAV-15
Content
    01 Antigravity device with equivalent resistance to pressure of 15cmH2O
Conteúdo
    Hpbio SpheraGrav
Code
    SPHERAGRAV-20
Content
    01 Antigravity device with equivalent resistance to pressure of 20cmH2O
Content
    Hpbio SpheraGrav
Code
    SPHERAGRAV-25
Content
    01 Antigravity device with equivalent resistance to pressure of 25 cmH2O
Conteúdo
    Hpbio SpheraGrav
Code
    SPHERAGRAV-30
Content
    01 Antigravity device with equivalent resistance to pressure of 30 cmH2O
Conteúdo
    Hpbio SpheraGrav
Code
    SPHERAGRAV-35
Content
    01 Antigravity device with equivalent resistance to pressure of 35 cmH2O
Conteúdo
    Hpbio SpheraGrav
SPHERA PRO + SPHERA GRAV
Code
    UPRO10215-G10
Content
    01 Hydrocephalus valve Sphera Pro pre-attached to:
    01 Sphera Grav-10 device; 01 Peritonial catheter of 102 cm; 01 RHH-2 reservoir;
    01 Cerebral ventricular straight catheter of 15cm with stainless steel stylet and angular.
Conteúdo
    SpheraPro-SpheraGrav-Reservatorio
Code
    UPRO10215-G15
Content
    01 Hydrocephalus valve Sphera Pro pre-attached to:
    01 Sphera Grav-15 device; 01 Peritonial catheter of 102 cm; 01 RHH-2 reservoir;
    01 Cerebral ventricular straight catheter of 15cm with stainless steel stylet and angular.
Conteúdo
    SpheraPro-SpheraGrav-Reservatorio
Code
    UPRO10215-G20
Content
    01 Hydrocephalus valve Sphera Pro pre-attached to:
    01 Sphera Grav-20 device; 01 Peritonial catheter of 102 cm; 01 RHH-2 reservoir;
    01 Cerebral ventricular straight catheter of 15cm with stainless steel stylet and angular.
Conteúdo
    SpheraPro-SpheraGrav-Reservatorio
Code
    UPRO10215-G25
Content
    01 Hydrocephalus valve Sphera Pro pre-attached to:
    01 Sphera Grav-25 device; 01 Peritonial catheter of 102 cm; 01 RHH-2 reservoir;
    01 Cerebral ventricular straight catheter of 15cm with stainless steel stylet and angular.
Conteúdo
    SpheraPro-SpheraGrav-Reservatorio
Code
    UPRO10215-G30
Content
    01 Hydrocephalus valve Sphera Pro pre-attached to:
    01 Sphera Grav-30 device; 01 Peritonial catheter of 102 cm; 01 RHH-2 reservoir;
    01 Cerebral ventricular straight catheter of 15cm with stainless steel stylet and angular.
Conteúdo
    SpheraPro-SpheraGrav-Reservatorio
Code
    UPRO10215-G35
Content
    01 Hydrocephalus valve Sphera Pro pre-attached to:
    01 Sphera Grav-35 device; 01 Peritonial catheter of 102 cm; 01 RHH-2 reservoir;
    01 Cerebral ventricular straight catheter of 15cm with stainless steel stylet and angular.
Conteúdo
    SpheraPro-SpheraGrav-Reservatorio
Code
    UPRO10223-G10
Content
    01 Hydrocephalus valve Sphera Pro pre-attached to:
    01 Sphera Grav-10 device; 01 Peritonial catheter of 102 cm; 01 RHH-2 reservoir;
    01 Cerebral ventricular straight catheter of 23.5cm with stainless steel stylet and angular.
Conteúdo
    SpheraPro-SpheraGrav-Reservatorio
Code
    UPRO10223-G15
Content
    01 Hydrocephalus valve Sphera Pro pre-attached to:
    01 Sphera Grav-15 device; 01 Peritonial catheter of 102 cm; 01 RHH-2 reservoir;
    01 Cerebral ventricular straight catheter of 23.5cm with stainless steel stylet and angular.
Conteúdo
    SpheraPro-SpheraGrav-Reservatorio
Code
    UPRO10223-G20
Content
    01 Hydrocephalus valve Sphera Pro pre-attached to:
    01 Sphera Grav-20 device; 01 Peritonial catheter of 102 cm; 01 RHH-2 reservoir;
    01 Cerebral ventricular straight catheter of 23.5cm with stainless steel stylet and angular.
Conteúdo
    SpheraPro-SpheraGrav-Reservatorio
Code
    UPRO10223-G25
Content
    01 Hydrocephalus valve Sphera Pro pre-attached to:
    01 Sphera Grav-25 device; 01 Peritonial catheter of 102 cm; 01 RHH-2 reservoir;
    01 Cerebral ventricular straight catheter of 23.5cm with stainless steel stylet and angular.
Conteúdo
    SpheraPro-SpheraGrav-Reservatorio
Code
    UPRO10223-G30
Content
    01 Hydrocephalus valve Sphera Pro pre-attached to:
    01 Sphera Grav-30 device; 01 Peritonial catheter of 102 cm; 01 RHH-2 reservoir;
    01 Cerebral ventricular straight catheter of 23.5cm with stainless steel stylet and angular.
Conteúdo
    SpheraPro-SpheraGrav-Reservatorio
Code
    UPRO10223-G35
Content
    01 Hydrocephalus valve Sphera Pro pre-attached to:
    01 Sphera Grav-35 device; 01 Peritonial catheter of 102 cm; 01 RHH-2 reservoir;
    01 Cerebral ventricular straight catheter of 23.5cm with stainless steel stylet and angular.
Conteúdo
    SpheraPro-SpheraGrav-Reservatorio
PROGRAMMING DEVICE
Code
    REG-PRO
Content
    01 Positioner
    01 Reader
    01 Programmer
Content
    RegPro-Squema2

Radiopacity

Identification of the implanted valve

Sphera-Pro-Raio-XAE
Sphera-Pro-Raio-XBE
Sphera-Pro-Raio-XCE
Sphera-Pro-Raio-XDE
X-ray image of Sphera Pro for the 08 pressure settings, showing the inlet and outlet connectors, both magnets, the direction arrow, and the indicative mark for the valve laterality.

Note: The technical information for these products is not limited to the characteristics presented in this catalog. For complete information, request the Instructions for use at info@hpbio.com.br.