SELF-REGULATING NONOBSTRUCTIVE HYDROCEPHALIC VALVE

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(Investigator's Abstract): Hydrocephalus is a neurological disease related to excessive rise of cerebrospinal fluid (CSF) in the ventricles of the brain thus requiring immediate surgical implant. In U.S., an estimated 60,000 infants and adults suffer from this devastating disease (Marlin, 1990). Presently each hydrocephalic patient requires shunt revisions about 3 to 4 times in their lives due to serious problems (Sainte-Rose, 1993). A new patented design (US Patent nos: 5,071,408 & 5,411,473) using a self-adjusting non-obstructive valve system has been achieved (Ahmed, 1970). This unique venturi system regulates ventricular pressure from 40-50mm Hg with a relative flow rate of 0.3ml/mt. A special telescopic attachment helps to expand the tube to accommodate growth in infants. This design is ready and prototype soft molds are underway. For in-vitro testing, a human hydrocephalus model (Hakim 1973) will be used. Animal studies and human trials are planned for phase II. According to a 1990 B.B.I. market research, the US market for Hydrocephalus shunts is about $100 million and about $200 million worldwide requiring about 300,000 implants. |The Ahmed Glaucoma Valve (FDA approved:1993), implanted in over 5000 patients, is the basis of the hydrocephalus valve thus assuring its safety, effectiveness and marketability.