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Development and evaluation of the modiolar research array – multi-centre collaborative study in human temporal bones

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...

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Autores principales: Briggs, Robert J S, Tykocinski, Michael, Lazsig, Roland, Aschendorff, Antje, Lenarz, Thomas, Stöver, Timo, Fraysse, Bernard, Marx, Mathieu, Roland, J Thomas, Roland, Peter S, Wright, Charles G, Gantz, Bruce J, Patrick, James F, Risi, Frank
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Maney Publishing 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3159433/
https://www.ncbi.nlm.nih.gov/pubmed/21917200
http://dx.doi.org/10.1179/1754762811Y0000000007
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author Briggs, Robert J S
Tykocinski, Michael
Lazsig, Roland
Aschendorff, Antje
Lenarz, Thomas
Stöver, Timo
Fraysse, Bernard
Marx, Mathieu
Roland, J Thomas
Roland, Peter S
Wright, Charles G
Gantz, Bruce J
Patrick, James F
Risi, Frank
author_facet Briggs, Robert J S
Tykocinski, Michael
Lazsig, Roland
Aschendorff, Antje
Lenarz, Thomas
Stöver, Timo
Fraysse, Bernard
Marx, Mathieu
Roland, J Thomas
Roland, Peter S
Wright, Charles G
Gantz, Bruce J
Patrick, James F
Risi, Frank
author_sort Briggs, Robert J S
collection PubMed
description 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.
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spelling pubmed-31594332011-08-22 Development and evaluation of the modiolar research array – multi-centre collaborative study in human temporal bones Briggs, Robert J S Tykocinski, Michael Lazsig, Roland Aschendorff, Antje Lenarz, Thomas Stöver, Timo Fraysse, Bernard Marx, Mathieu Roland, J Thomas Roland, Peter S Wright, Charles G Gantz, Bruce J Patrick, James F Risi, Frank Cochlear Implants Int Articles 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. Maney Publishing 2011-08 /pmc/articles/PMC3159433/ /pubmed/21917200 http://dx.doi.org/10.1179/1754762811Y0000000007 Text en © W.S. Maney & Son Ltd 2011 http://creativecommons.org/licenses/by/2.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Articles
Briggs, Robert J S
Tykocinski, Michael
Lazsig, Roland
Aschendorff, Antje
Lenarz, Thomas
Stöver, Timo
Fraysse, Bernard
Marx, Mathieu
Roland, J Thomas
Roland, Peter S
Wright, Charles G
Gantz, Bruce J
Patrick, James F
Risi, Frank
Development and evaluation of the modiolar research array – multi-centre collaborative study in human temporal bones
title Development and evaluation of the modiolar research array – multi-centre collaborative study in human temporal bones
title_full Development and evaluation of the modiolar research array – multi-centre collaborative study in human temporal bones
title_fullStr Development and evaluation of the modiolar research array – multi-centre collaborative study in human temporal bones
title_full_unstemmed Development and evaluation of the modiolar research array – multi-centre collaborative study in human temporal bones
title_short Development and evaluation of the modiolar research array – multi-centre collaborative study in human temporal bones
title_sort development and evaluation of the modiolar research array – multi-centre collaborative study in human temporal bones
topic Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3159433/
https://www.ncbi.nlm.nih.gov/pubmed/21917200
http://dx.doi.org/10.1179/1754762811Y0000000007
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