1. Stability of flexible thin-film metallization stimulation electrodes: analysis of explants after first-in-human study and improvement of in vivo performance
- Author
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Pawel Maciejasz, David Andreu, Ken Yoshida, Xavier Navarro, Silvestro Micera, Stanisa Raspopovic, Paul Čvančara, Tim Boretius, Victor Lopezalvarez, Eduardo Fernandez, Giuseppe Granata, Thomas Stieglitz, Paolo Maria Rossini, David Guiraud, Jean-Louis Divoux, Winnie Jensen, Francesco Maria Petrini, Bernstein Center Freiburg (BCF), Albert-Ludwigs-Universität Freiburg, Department of Microsystems Engineering [Freiburg] (IMTEK), University of Freiburg [Freiburg], Universitat Autònoma de Barcelona (UAB), Otto Bock Healthcare GmbH, Contrôle Artificiel de Mouvements et de Neuroprothèses Intuitives (CAMIN), Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria), Eidgenössische Technische Hochschule - Swiss Federal Institute of Technology [Zürich] (ETH Zürich), Fondation Bertarelli Chair inTranslational Neuroscience and Neuroengineering [Lausanne], Ecole Polytechnique Fédérale de Lausanne (EPFL)-Fondation Bertarelli, Scuela Santa Anna (SSSA), Scuola Universitaria Superiore Sant'Anna [Pisa] (SSSUP), Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università cattolica del Sacro Cuore [Piacenza e Cremona] (Unicatt), Perdue University, Center for Sensory-Motor Interaction (SMI), Aalborg University [Denmark] (AAU), AXONIC - OBELIA dept, MXM-Laboratoires de Techologies Médicales, Center for Neuroprosthetics and Institute of Bioengineering, EPFL.-Fondation Bertarelli, and Fondazione 'Policlinico Universitario A. Gemelli' [Rome]
- Subjects
Thin-film ,Materials science ,Electrode ,[SDV.NEU.NB]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Neurobiology ,0206 medical engineering ,Biomedical Engineering ,02 engineering and technology ,polyimide ,[SPI.AUTO]Engineering Sciences [physics]/Automatic ,03 medical and health sciences ,Cellular and Molecular Neuroscience ,chemistry.chemical_compound ,0302 clinical medicine ,Amputees ,Electric Impedance ,[SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO] ,Silicon carbide ,Animals ,Humans ,neural interfaces ,Thin film ,Electrodes ,Delamination ,electrode ,stability ,thin-film ,Prostheses and Implants ,020601 biomedical engineering ,Electric Stimulation ,Electrodes, Implanted ,Microelectrode ,chemistry ,Implant ,Neural interfaces ,Polyimide ,Stability ,Microelectrodes ,Failure mode and effects analysis ,Layer (electronics) ,030217 neurology & neurosurgery ,Biomedical engineering - Abstract
Objective Micro-fabricated neural interfaces based on polyimide (PI) are achieving increasing importance in translational research. The ability to produce well-defined micro-structures with properties that include chemical inertness, mechanical flexibility and low water uptake are key advantages for these devices. Approach This paper reports the development of the transverse intrafascicular multichannel electrode (TIME) used to deliver intraneural sensory feedback to an upper-limb amputee in combination with a sensorized hand prosthesis. A failure mode analysis on the explanted devices was performed after a first-in-human study limited to 30 d. Main results About 90% of the stimulation contact sites of the TIMEs maintained electrical functionality and stability during the full implant period. However, optical analysis post-explantation revealed that 62.5% of the stimulation contacts showed signs of delamination at the metallization-PI interface. Such damage likely occurred due to handling during explantation and subsequent analysis, since a significant change in impedance was not observed in vivo. Nevertheless, whereas device integrity is mandatory for long-term functionality in chronic implantation, measures to increase the bonding strength of the metallization-PI interface deserve further investigation. We report here that silicon carbide (SiC) is an effective adhesion-promoting layer resisting heavy electrical stimulation conditions within a rodent animal trial. Optical analysis of the new electrodes revealed that the metallization remained unaltered after delivering over 14 million pulses in vivo without signs of delamination at the metallization-PI interface. Significance Failure mode analysis guided implant stability optimization. Reliable adhesion of thin-film metallization to substrate has been proven using SiC, improving the potential transfer of micro-fabricated neural electrodes for chronic clinical applications., Journal of Neural Engineering, 17 (4), ISSN:1741-2560, ISSN:1741-2552
- Published
- 2020