Graeme Clark Collection

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    Cochlear pathology following reimplantation of a multichannel scala tympani electrode array in the macaque
    Shepherd, Robert K. ; Clark, Graeme M. ; Xu, Shi-Ang ; Pyman, Brian C. ( 1995)
    The histopathologic consequence of removing and reimplanting intracochlear electrode arrays on residual auditory nerve fibers is an important issue when evaluating the safety of cochlear prostheses. The authors have examined this issue by implanting multichannel intracochlear electrodes in macaque monkeys. Macaques were selected because of the similarity of the surgical technique used to insert electrodes into the cochlea compared to that in humans, in particular the ability to insert the arrays into the upper basal turn. Five macaques were bilaterally implanted with the Melbourne/Cochlear banded electrode array. Following a minimum implant period of 5 months, the electrode array on one side of each animal was removed and another immediately implanted. The animals were sacrificed a minimum of 5 months following the reinsertion procedure, and the cochleas prepared for histopathologic analysis. Long-term implantation of the electrode resulted in a relatively mild tissue response within the cochlea. Results also showed that inner and outer hair cell survival, although significantly reduced adjacent to the array, was normal in 8 of the 10 cochleas apicalward. Moreover, the electrode reinsertion procedure did not appear to adversely affect this apical hair cell population. Significant new bone formation was frequently observed in both control and reimplanted cochleas close to the electrode fenestration site and was associated with trauma to the endosteum and/or the introduction of bone chips into the cochlea at the time of surgery. Electrode insertion trauma, involving the osseous spiral lamina or basilar membrane, was more commonly observed in reimplanted cochleas. This damage was usually restricted to the lower basal turn and resulted in a more extensive ganglion cell loss. Finally, in a number of cochleas part of the electrode array was located within the scala media or scala vestibuli. These electrodes did not appear to evoke a more extensive tissue response or result in more extensive neural degeneration compared with electrodes located within the scala tympani. In conclusion, the present study has shown that the reimplantation of a multichannel scala tympani electrode array can be achieved with minimal damage to the majority of cochlear structures. Increased insertion trauma, resulting in new bone formation and spiral ganglion cell loss, can occur in the lower basal turn in cases where the electrode entry point is difficult to identify due to proliferation of granulation and fibrous tissue.
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    Surgery for the safe insertion and reinsertion of the banded electrode array
    Clark, Graeme M. ; Pyman, B. C. ; Webb, R. L. ; Franz, B. K-H. G. ; Redhead, T. J. ; Shepherd, R. K. ( 1987)
    Adhering to the surgical technique outlined in the protocol for the Nucleus implant has resulted in over 100 patients worldwide obtaining significant benefit from multichannel stimulation. A detailed analysis of the results in 40 patients shows that it improves their awareness of environmental sounds and their abilities in understanding running speech when combined with lipreading. In addition, one third to one half of the patients also understand significant amounts of running speech without lipreading and some can have interactive conversations over the telephone. It is clear that any insertion trauma is not significant, which is confirmed by the excellent clinical results.
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    Histopathology following electrode insertion and chronic electrical stimulation
    Shepherd, R. K. ; Clark, Graeme M. ; Pyman, B. C. ; Webb, R. L. ; Murray, M. T. ; Houghton, M. E. (Raven Press, 1985)
    We have examined a number of safety issues associated with cochlear implants. This work has been primarily designed to evaluate the histopathological effects of intracochlear electrode implantation and chronic electrical stimulation. The results of these studies may be summarized as follows: 1) The insertion of the banded free-fit scala tympani array into human cadaver temporal bones produces minimal damage, occurring primarily to a localized region of the spiral ligament. This damage would not result in significant neural degeneration and thus, would not compromise the efficacy of the multiple channel device; 2) chronic intracochlear electrical stimulation for continuous periods of 500 to 2000 hours, using charge balanced biphasic current pulses developing charge densities of 18-32 }?C/cm2. geom./phase, does not adversely affect the spiral ganglion cell population; 3) labyrinthine infection severely reduces the viable spiral ganglion cell population; 4) the formation of new bone present in approximately half of the animals we have implanted --is not associated with electrical stimulation per se; 5) scanning electron microscope studies of electrodes subjected to long periods of intracochlear electrical stimulation reveals minimal platinum dissolution when compared with unstimulated control electrodes, and electrodes that have been stimulated for similar periods in inorganic saline.