Design and benchmark testing of a bicorporal pump for the treatment of normal-pressure hydrocephalus and idiopathic intracranial hypertension

Abstract

Object Addressing overdrainage and its associated complications is still one of the greatest challenges for future shunt designs for normal-pressure hydrocephalus and idiopathic intracranial hypertension. Nevertheless, as evidenced by tap test procedures, a small amount of CSF drainage seems to be enough to relieve patients' symptoms in most cases and, therefore, in opposition to other types of hydrocephalus, continuous CSF drainage may not be absolutely warranted. In such a clinical scenario, intermittent controlled drainage of a small amount of CSF during specific periods of the day through a 2-system pump may provide several advantages over continuous drainage of current single-system shunts. The goal in this study was to design and test an innovative concept of a bicorporal pump composed of a 2-part system. The first component was designed to be implanted in the patient and act as a pump connected to standard catheter tubing. The second component was designed to be used as an external device outside of the body and function as a power supply and control system. Ultimately, flow will only occur when the system is powered by the external device. Methods Testing and comparisons were performed to evaluate free fluid flow and the maximal flow after pumping in the standing and supine positions. After this, the authors compared the hydrodynamic effects of 2 different housing systems (2- and 3-in systems). An attenuation test was performed to show the effects of electromagnetic forces at progressively increasing distances. Finally, a biocompatibility report of the raw material used in the pilot design was completed. Results In the supine position, the effect of pumping was observed to increase the volumetric flow at a rate similar to or higher than that yielded in the free-flow tests. In relation to the attenuation test, it was observed that the volume drops off fairly quickly as the air gap distance was increased until ultimately reaching zero, with approximately 15 mm between the 2 components. In relation to the testing force, the 2-in housing model showed a considerable increase in the required electromagnetic force over the 3-in housing. Conclusions The authors successfully designed and tested a new intermittent drainage system through a bicorporal shunt, which provides several advantages over current single-system continuous drainage pumps. According to the authors' benchmark results, the 3-in housing model seems to be a better choice as it requires less force from the external electromagnet control. Moreover, attenuation tests demonstrated that, for proper functioning, the gap distance between the external and implanted devices should not be greater than 15 mm. Such initial benchmark results confirm the feasibility of such innovative design and provide support for future testing of the system in in vivo animal models and in future clinical series.