Graeme Clark Collection
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ItemBiological safety(Singular Publishing, 1997)Biological safety has been extensively studied at the Department of Otolaryngology, The University of Melbourne, for cochlear implantation in adults, and subsequently for specific issues in infants and young children. Many of the studies have general applicability to cochlear implantation, but some have specific relevance to the Nucleus (Cochlear Limited) multiple-channel cochlear implant systems, and have been fundamental to their approval by the U.S. Food and Drug Administration (FDA). The Nucleus system was first approved by the FDA as safe and effective for postlinguistically deaf adults in October 1985, and 5 years later, on 27 June 1990, was approved for use in children from 2 years of age and older. The general research questions studied for adults are directly relevant for children and infants, but there are also specific questions that need to be answered when operating on children under 2 years of age.
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ItemEvaluation of expandable leadwires for paediatric cochlear implants( 1993)The development of cochlear implants for use in very young children (1-2 years old) will require techniques designed to accommodate temporal bone growth. Previous anatomic studies have shown that the leadwire of a cochlear implant must be capable of expanding up to 20 mm between the round window and the implanted receiver-stimulator in response to skull growth. In the present study morphologic and biomechanical evaluation of five expandable leadwire designs was conducted following their implantation in young cats. Two helical shaped leadwire designs frequently exhibited extensive fibrous tissue adhesions and broke during long-term implantation. In contrast, thin, flexible Silastic envelopes were effective in minimizing tissue adhesions. Residual V- and Z-shaped leadwires, placed in these envelopes, showed little evidence of fibrous tissue adhesions following implantation periods of up to 2 years. Moreover, these leadwires readily expanded both during the growth of the animal and when biomechanical expansion studies performed at the completion of the implant period. These expandable leadwire designs appear to be appropriate candidates for use in pediatric cochlear implants.
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ItemPaediatric cochlear implantation: radiologic observations of skull growth( 1993)We investigated the effects of long-term implantation of auditory prostheses on skull growth in young animals. Four monkeys were implanted with dummy cochlear implants at 6 months of age. To simulate implantation in children, the bed for the receiver-stimulator or interconnecting plug was drilled across a calvarial suture down to the underlying dura. Plain skull oentgenograms were periodically taken to monitor head growth for up to 3 years after implantation. These longitudinal measurements revealed no significant asymmetric skull growth. Postmortem measurements using computed tomographic scans confirmed these results and showed no significant difference in the intracranial volumes between the implanted and control sides of each animal or between experimental and nonimplanted control monkeys. These results suggest that long-term cochlear implantation in very young children will not cause any significant deformity of the skull.
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ItemThe postnatal growth of the temporal bone and its implications for cochlear implantation in children( 1993)The postnatal growth of the human temporal bone was examined by direct anatomical measurements on 60 cadaver specimens of all ages. The bones were dissected as one would perform cochlear implant surgery using a posterior tympanotomy approach. Nineteen anatomical /surgical landmarks with implications for cochlear implant surgery were identified on each bone and the distance between these points measured. The temporal hone was found to be a complex structure, phylogenetically, anatomically and functionally consisting of four different parts with independent postnatal development. The inner and middle cars were adult size at birth. The external auditory canal and most parts of the temporal hone were subject to significant lateral growth. The size of the pneumatised mastoid increased in all directions. In the facial recess, however, no postnatal growth was observed. Between birth and adulthood an average of 12 mm (SD 5 mm) of growth was seen directly between the sino-dural angle and the round window, the landmarks approximating the Implantation site for the receiver-stimulator and the electrode entry point into the inner car. However, if an electrode leadwire is fixed at a cortical fixation site such as the posterosuperior point of Macewen's triangle, the leadwire would be subject to approximately 20 mm of growth. These results indicate that a paediatric cochlear implant design incorporating an expandable leadwire to accommodate this growth should allow up to 25 mm of leadwire lengthening. The fossa incudis showed no growth relative to the round window and was found to be a convenient fixation site for the electrode array close to the cochlea. From an anatomical and surgical point of view, cochlear implantation in very young children is feasible, provided the electrode array is secured and the design accommodates for controlled leadwire lengthening.
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ItemExpandable leadwires for a paediatric cochlear implant [Abstract]( 1993)Anatomic studies of skull growth have shown an increase (about 20 mm) in the distance between the round window and the asterion where the receiver-stimulator is usually located. In order to accommodate the skull growth of young patients, an expandable leadwire connecting the receiver-stimulator and the electrode array is necessary. Several expandable leadwires were evaluated in experimental animals, including helical leadwires protected by Silastic tubes and leadwires, with "V" or "W"-shaped levels in a single phase, and protected by thin Silastic or Teflon bags. The leadwires together with their controls were implanted on young animal's scapulae, temporal and parietal bones and in subcutaneous tissue. The in vivo expansion of the leadwire was monitored by periodic x-ray examination and the force to expand the leadwire was measured at the completion of implantation. The results showed that helical leadwires weresurrounded by fibrous tissue and a large force was required to expand them. The V or W-shaped leadwires were able to expand up to 20 mm in vivo and only a moderate force was required to expand them. For most of the cases, there was none or little fibrous tissue in Silastic or Teflon bags. The results indicated that for a paediatric cochlear implant, leadwires with V or W-shaped levels could, expand and biocompatible envelopes could effectively protect the leadwires from being bound by fibrous tissue.
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ItemPaediatric cochlear implantation: radiological and histopathological studies of skull growth in the monkey( 1993)The human skull undergoes significant growth within the first two years of life (Dahm et aI, 1992). Therefore, before children under two can be considered candidates for cochlear implantation, the effects of the surgical procedure on subsequent skull growth must be well understood. To evaluate the effects of implantation on skull growth four macaque monkeys were implanted with dummy cochlear implants at six months of age. To model the procedure in the very young child, the bed for the receiver-stimulator was drilled across a calvarial suture down to the underlying dura and an electrode array inserted into the scala tympani via a mastoidectomy and posterior,tympanotomy. Plain skull radiographs were perioqical1y taken to monitor skull growth for periods of up to three years following implantation. Their longitudinal measurements revealed no evidence of asymmetrical skull growth when compared with unimplanted control animals. Computer tomographic scans taken at post-mortem confirmed these findings. Finally, subsequent histopathological evaluation of the receiver-stimulator package bed indicated that it becomes obliterated by hard tissue, resulting in a localized flattening of the vault under the receiver-stimulator. However, this tissue exhibited histological evidence of sutures, indicating that the surgical procedure should not lead to premature sutural closure. In conclusion, the present experimental results suggest that long-term cochlear implantation in very young children will not lead to any significant skull deformity.
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ItemThe effect of inflammation on blood vessel area as a cause of variation in ganglion cell density measurements in the cat cochlea [Abstract]( 1992)The success of a cochlear implant depends on an adequate number of surviving spiral ganglion cells. Further loss of ganglion cells may arise from the biology of cochlear implantation itself. The quantitative analysis of ganglion cells is, therefore, an important consideration when assessing the biological safety of a cochlear implant.
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ItemThe postnatal growth of the temporal bone and its implications for cochlear implantation in children( 1993)The growth of the human temporal bone is of practical concern if young children are implanted. It is feared that the normal development of the temporal bone after implantation may displace the electrode array and jeopardize the success of the device. To evaluate the extent of growth 60 cadaver specimens of all ages were examined by direct anatomical measurements. The bones were dissected by imitating the cochlear implantation surgical procedure in the temporal bone laboratory. 19 anatomical/surgical landmarks with implications for cochlear implant surgery were identified and the distance between them measured. The inner ear and middle ear are adult size at birth. The external auditory canal and most parts of the temporal bone are subject to significant lateral growth. The size of the pneumatised mastoid was found to increase in all directions. In the facial recess however, no postnatal growth could be noted. Between birth and adulthood a considerable amount of growth is to be expected between the sino-dural angle and the round window, the landmarks representing the implantation site for the receiver/stimulator and the electrode entry site respectively. From an anatomical and surgical point of view, cochlear implantation in very young children proved to be feasible, provided the electrode array is secured close to the cochlea and the design accommodates for controlled leadwire lengthening.
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ItemThe postnatal growth of the temporal bone and its implications for cochlear implants in children( 1993)An understanding of the postnatal growth of the temporal bone is an important prerequisite for the development of cochlear implantation in very young children. Such information will have an important bearing on both the design of the implant and the surgical procedure. We have measured the postnatal growth of the temporal bone by direct anatomical measurements on 60 cadaver specimens with ages ranging from 2 months to 84 years. Nineteen anatomical landmarks with implications for cochlear implant surgery were identified on each bone and the distance between these points measured. The inner and middle ears were adult size at birth. The external auditory canal and most parts of the temporal bone were subject to significant lateral growth. The size of the pneumatized mastoid increased with age in all directions. Significantly, no postnatal growth was observed in the facial recess. The fossa incudis showed no growth relative to the round window and was found to be a convenient fixation site for the electrode array close to the cochlea. However, with the electrode leadwire fixed at a cortical site such as the osterosuperior point of McEwan's triangle, the leadwire would be subject to approximately 20 mm of growth between this point and the cochlea. These anatomical results indicate that a paediatric cochlear implant would require an expandable leadwire to accommodate these growth changes.
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ItemMultichannel cochlear implants in children: an overview of experimental and clinical results at the University of Melbourne [Opening Lecture]( 1992)During the last decade there has been great progress in the clinical management of profound, postlinguistically deafened adults through the use of multichannel cochlear implants. The device developed by The University of Melbourne in association with Cochlear Pty Ltd, electrically stimulates selective regions of the auditory nerve using an array of 22 platinum (Pt) electrodes located in the scala tympani. Its development followed basic experimental studies and the development and evaluation of a prototype device in the 1970's. Following safety studies and a successful clinical trial, the Melbourne/Cochlear multichannel implant was approved for use in adults by the United States Food and Drug Administration (FDA) in 1985. More than 3000 patients throughout the world have since been implanted with this device, many being able to understand a significant amount of unfamiliar, connected speech without lipreading Following miniaturization of the implant, it became suitable for use with children. In 1990, after additional biological safety and clinical investigations, the FDA approved the use of the Melbourne/Cochlear multichannel implant for profoundly deaf children above the age of two years. And in 1991, the device received the medical device implantation approval certificate from the Japanese Government. The present paper presents an overview of our recent biological safety studies and clinical experience in children, and discusses the likely future development of these devices.