Sphera Duo Hydrocephalus Shunt System

The HPBIO Sphera Duo is a fixed-pressure (monopressure) hydrocephalus shunt valve manufactured by HPBIO in Brazil, available in Pakistan from National Enterprises. In referrals and requisitions this is usually just the shunt system or hydrocephalus shunt.

Sphera Duo uses a ball-in-cone pressure control mechanism made of ruby, with a transparent medical-grade silicone body and polysulfone base, compatible with both CT and MRI imaging. It is supplied in Adult, Infantile, Neonatal Plus, and Neonatal sizes, across four pressure ranges – high, medium, low, and extra-low – with radiopaque pressure and flow markings visible on post-implantation imaging.

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Description

The HP-BIO Sphera Pro Hydrocephalus Programmable Shunt System is a state-of-the-art neurosurgical solution designed for precise, non-invasive cerebral intraventricular pressure control. Engineered to overcome the challenges of traditional shunts, the Sphera Pro offers surgeons 8 distinct pressure settings (ranging from 1 cmH2O to 21 cmH2O) that can be adjusted painlessly and without surgical intervention using a dedicated external programming kit.

Security is a core focus of the Sphera Pro design. To prevent accidental deprogramming—a common issue when patients are exposed to magnetic fields in daily life or during diagnostic procedures—the valve features an exclusive double-locking rotor mechanism. Supported by dual spring-loaded mechanical latches moving in opposite directions, the valve maintains its selected pressure setting even when exposed to strong external magnetic fields, including Magnetic Resonance Imaging (MRI) scans of up to 3 Teslas. The system also features a new integrated flushing reservoir equipped with a protective needle guard base to facilitate safe CSF sampling and pressure readings without risk of bottom puncture.

Postural Overdrainage Control with Sphera Grav

For patients suffering from Normal Pressure Hydrocephalus (NPH) or those sensitive to postural changes, the Sphera Pro system can be supplied pre-assembled with the Sphera Grav Antigravity Device. The Sphera Grav automatically adjusts the drainage resistance as the patient transitions from a lying (supine) position to an upright (orthostatic) position. Using micro-spheres made of tungsten and ruby, the device adds physiological resistance in the vertical position, preventing hyper-drainage and maintaining a constant, safe intracranial pressure (ICP).

Key Features & Clinical Benefits

  • 8 Adjustable Pressure Levels: Non-invasive adjustment from 1.0 to 21.0 cmH2O to accommodate the patient’s changing clinical needs over time.
  • MRI Safety up to 3 Tesla: Exclusive spring-assisted double locking mechanism prevents accidental setting changes under diagnostic magnetic fields.
  • Integrated Puncture-Proof Reservoir: Puncture-resistant base plate protects the underlying chamber during needle insertions for CSF sampling.
  • Automatic Postural Compensation: Optional Sphera Grav device compensates for vertical posture, minimizing the risk of subdural hematomas.
  • Radiopaque Markings: Graphic indicator marks and directional arrows on the valve body are visible under X-ray, allowing easy verification of the current pressure level.
  • Kink-Resistant Catheters: Supplied with transparent silicone ventricular and peritoneal catheters featuring a radiopaque fillet for safe subcutaneous routing.

Technical Specifications

Specification Parameter Product Detail / Value
Pressure Settings 8 Levels (1.0, 3.0, 6.5, 10.0, 13.0, 16.5, 19.0, 21.0 cmH2O)
MRI Compatibility Safe up to 3.0 Teslas (Double-locking mechanism)
Valve Material Polysulfone body with medical-grade silicone coating & titanium connectors
Sphera Grav Options 6 Resistance options (10, 15, 20, 25, 30, or 35 cmH2O)
Sphera Grav Composition Tungsten & ruby spheres, titanium connectors, polysulfone body, silicone coating
Ventricular Catheter Length 15 cm or 23.5 cm (includes stainless steel stylet & 90° angle former)
Peritoneal Catheter Length 102 cm or 120 cm (with radiopaque filet)
Programming Kit (REG-PRO) Includes 1x Positioner, 1x Compass, and 1x Programmer

Available Order Configurations

Order Code System Configuration Details
PRO10215R Sphera Pro Valve with Reservoir, 15 cm Ventricular Catheter, 102 cm Peritoneal Catheter
PRO10223R Sphera Pro Valve with Reservoir, 23.5 cm Ventricular Catheter, 102 cm Peritoneal Catheter
UPRO10223-G10 Pre-assembled Sphera Pro with Reservoir + Sphera Grav-10 Device, 23.5 cm Ventricular Catheter, 102 cm Peritoneal Catheter
UPRO10223-G20 Pre-assembled Sphera Pro with Reservoir + Sphera Grav-20 Device, 23.5 cm Ventricular Catheter, 102 cm Peritoneal Catheter
REG-PRO External Programming Device Kit (Non-invasive Positioner, Compass, and Programmer tool)

Additional information

Manufacturer

HP-BIO

Origin

Brazil

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