Lumbo-venous CSF Shunt for Treatment of Communicating Hydrocephalus.

PROJECT SUMMARY/ABSTRACT This proposal’s long-term goal is to improve the care of patients with communicating hydrocephalus, normal pressure hydrocephalus and idiopathic intracranial hypertension. Use of CSF diversion systems such as lumboperitoneal shunts, ventriculoperitoneal shunts and ventriculoatrial shunts is well established, however, substantial limitations remain. Current shunt systems have been in existence for decades, however they do suffer from many limitations. Shunt revision rates due to shunt failure are extremely high with up to one-third of patients undergoing revision surgery within one year. Infection rates are high at 20%. Other common complications include hemorrhage and obstruction. A few groups have proposed the development of novel minimally invasive and even endovascularly delivered CSF diversion systems. One such system involves the delivery of a puncture needle to the inferior petrosal sinus at the skull base followed by the delivery of a shunt catheter which allows for CSF diversion from the cerebellopontine angle to the internal jugular vein. Early studies with this device have been promising, but there are concerns with this anatomical approach given the proximity of the puncture needle to critical structures including the basilar artery and brainstem. Through our experience in the treatment of a rare form of spinal CSF leaks called CSF-venous fistulas, our group has developed a very large experience in the transcatheter navigation of the spinal venous space, particularly the epidural and foraminal veins and have realized the potential feasibility of transvenous transcatheter delivery of catheters from the spinal venous space to the CSF space for treatment of CSF accumulation disorders. We have demonstrated the anatomic and technical feasibility in cadaver models. In this Phase I STTR program, we are proposing the development of a novel Lumbo-venous CSF Shunt for Treatment of Communicating Hydrocephalus. This novel catheter system includes a novel 6.5Fr steerable sheath, transvenous dural puncture needle and an innovative shunt catheter implant design that allows for equilibration of CSF pressures with the common iliac vein and easy retrievability. If successful, our Lumbo-venous CSF Shunt system will enhance care of patients requiring CSF diversion treatments.