Journal article
Development and evaluation of the modiolar research array - multi-centre collaborative study in human temporal bones
Cochlear implants international, Vol.12(3), pp.129-139
08/01/2011
DOI: 10.1179/1754762811Y0000000007
PMCID: PMC3159433
PMID: 21917200
Abstract
Objective
Multi-centre collaborative study to develop and refine the design of a prototype thin perimodiolar cochlear implant electrode array and to assess feasibility for use in human subjects.
Study Design
Multi-centre temporal bone insertion studies.
Materials and Methods
The modiolar research array (MRA) is a thin pre-curved electrode that is held straight for initial insertion with an external sheath rather than an internal stylet. Between November 2006 and February 2009, six iterations of electrode design were studied in 21 separate insertion studies in which 140 electrode insertions were performed in 85 human temporal bones by 12 surgeons. These studies aimed at addressing four fundamental questions related to the electrode concept, being: (1) Could a sheath result in additional intra-cochlear trauma? (2) Could a sheath accommodate variations in cochlea size and anatomies? (3) Could a sheath be inserted via the round window? and (4) Could a sheath be safely removed once the electrode had been inserted? These questions were investigated within these studies using a number of evaluation techniques, including X-ray and microfluoroscopy, acrylic fixation and temporal bone histologic sectioning, temporal bone microdissection of cochlear structures with electrode visualization, rotational tomography, and insertion force analysis.
Results
Frequent examples of electrode rotation and tip fold-over were demonstrated with the initial designs. This was typically caused by excessive curvature of the electrode tip, and also difficulty in handling of the electrode and sheath. The degree of tip curvature was progressively relaxed in subsequent versions with a corresponding reduction in the frequency of tip fold-over. Modifications to the sheath facilitated electrode insertion and sheath removal. Insertion studies with the final MRA design demonstrated minimal trauma, excellent perimodiolar placement, and very small electrode dimensions within scala tympani. Force measurements in temporal bones demonstrated negligible force on cochlear structures with angular insertion depths of between 390 and 450°.
Conclusion
The MRA is a novel, very thin perimodiolar prototype electrode array that has been developed using a systematic collaborative approach. The different evaluation techniques employed by the investigators contributed to the early identification of issues and generation of solutions. Regarding the four fundamental questions related to the electrode concept, the studies demonstrated that (1) the sheath did not result in additional intra-cochlear trauma; (2) the sheath could accommodate variations in cochlea size and anatomies; (3) the sheath was more successfully inserted via a cochleostomy than via the round window; and (4) the sheath could be safely removed once the electrode had been inserted.
Details
- Title: Subtitle
- Development and evaluation of the modiolar research array - multi-centre collaborative study in human temporal bones
- Creators
- Robert J S Briggs - University of Melbourne and HEARing CRCMelbourneMichael Tykocinski - University of Melbourne and HEARing CRCMelbourneRoland Lazsig - Universität FreiburgAntje Aschendorff - Universität FreiburgThomas Lenarz - Medizinische Hochschule HannoverTimo Stöver - Medizinische Hochschule HannoverBernard Fraysse - Hôpital PurpanToulouseMathieu Marx - Hôpital PurpanToulouseJ Thomas Roland - New York UniversityPeter S Roland - University of TexasCharles G Wright - University of TexasBruce J Gantz - The University of Iowa Carver College of MedicineJames F Patrick - Cochlear LimitedSydneyFrank Risi - Cochlear LimitedSydney
- Resource Type
- Journal article
- Publication Details
- Cochlear implants international, Vol.12(3), pp.129-139
- Publisher
- Taylor & Francis
- DOI
- 10.1179/1754762811Y0000000007
- PMID
- 21917200
- PMCID
- PMC3159433
- ISSN
- 1467-0100
- eISSN
- 1754-7628
- Language
- English
- Date published
- 08/01/2011
- Academic Unit
- Neurosurgery; Otolaryngology
- Record Identifier
- 9984006460302771
Metrics
20 Record Views