A totally implantable drug delivery system for local therapy of the middle and inner ear.

Local therapy of middle and inner ear diseases is being used, but is restricted to cases of ear drum perforation or to repeated invasive intratympanic drug application by the physician. In accordance with the Medical Device Directive (class III), a bone-anchored, totally implantable drug delivery system (TI-DDS) has been developed. It includes a micropump for subcutaneous, patient-controlled activation, a drug reservoir and a septum port. A thin guide-wired catheter leads from the pump outlet to the point of application in the mastoid or middle ear cavities. Local inner ear therapy with suitable drugs is possible by positioning the catheter's end near the round window membrane. The system requires no battery and will offer a wide range of patient-controlled bolus applications (25 microliters per activation). We first analyzed the three-dimensional implantation geometry of the mastoid cavity. Basic micromechanical problems have been solved in order to create several prototypes. The TI-DDS has already undergone extensive in vitro testing. Recent results of pump rate precision and digital pressure force testing are promising. Local drug treatment for conditions such as lidocaine-sensitive tinnitus, secretory otitis media, Meniere's disease, localized pain and intralesional cancer is under discussion. Furthermore, local application of future biotechnological trophic factors for inner ear treatment is anticipated. The basic engineering is completed and initial animal tests are in preparation.