Abstract
Convection-enhanced delivery (CED) through an arborizing microneedle catheter system is an experimental drug delivery technique used to treat glioblastoma by providing a higher drug volume dispersed (Vd) of therapeutics directly to larger regions of brain tissue. A convection-enhanced thermo-chemotherapy catheter system (CETCS) can simultaneously deliver fluid and thermal energy to the infected area. The CETCS developed in our Medical Device Design lab comprises a bundle of 6 microneedles made from fiber optic capillary tubing, passed through a rigid cannula and individually arborized (branch-out). We are preparing CETCS for regulatory pathway application to advance it further toward clinical and human trials. In this paper, we performed three performance tests: infusion pressure, leakage, and constant pressure flow rate tests required by the FDA to file a traditional 510(K) based upon a potential predicate device. The high-pressure burst and leakage test showed that the CETCS can withstand an internal pressure of 100 psi with no leakage or failure in any connections and attachments, resulting in a substantial equivalency to the predicate devices. The constant pressure flow rate test showed a flow rate average of 0.64 ml/h under 0.7 psi and 1.69 ml/h under 2.1 psi of constant pressure using distilled water column, resulting in substantial equivalency to the predicate devices.
