Abstract
Neural implants are developed with regard to the general aspects of active implant design, packaging philosophies, and decisions on manufacturing methods. The focus of this chapter “Implantable Device Fabrication and Packaging” is laid on reliability of assembly and packaging concepts rather than on the details of how different devices could be developed best. The basic concepts of packaging are introduced that go back to the 1970s but are still fundamental to modern neural implants. Packaging and encapsulation are complemented by connectors, cables, and electrode arrays to cover the main building blocks of neural implants. Manufacturing methods span the scales from precision mechanics to the micromachining level. They are introduced on a fundamental level to help the reader select and combine system components on the way to robust and reliable implants. Foundations are complemented by recent reviews to guide readers deeper into the different topics and mirror developments against transferability and applicability in clinical settings.
Abbreviations
- AIMD:
-
Active implantable medical device
- ALD:
-
Atomic layer deposition
- ASIC:
-
Application-specific integrated circuit
- CAD:
-
Computer-aided design
- CAM:
-
Computer-aided manufacturing
- CE:
-
Conformité Européenne
- CT:
-
Computed tomography scan
- DBS:
-
Deep brain stimulation
- ECoG:
-
Electrocorticography
- EDP:
-
Ethylene pyrocatechol
- FDA:
-
Food and Drug Administration
- FEP:
-
Fluorinated ethylene propylene
- FPGA:
-
Field-programmable gate array
- HTCC:
-
High temperature co-fired ceramics
- IC:
-
Integrated electronic circuit
- IDE:
-
Investigational device exemption
- IPG:
-
Implantable pulse generator
- IrOx:
-
Iridium oxide
- LCP:
-
Liquid-crystal polymer
- LTCC:
-
Low temperature co-fired ceramics
- MDR:
-
Medical Device Regulation
- MEMS:
-
Microelectromechanical systems
- MIL-STD:
-
Military standard
- MRI:
-
Magnetic resonance imaging
- OHCI:
-
Occult hepatitis C viral infection
- PDMS:
-
Polydimethylsiloxane
- PEI:
-
Polyesterimide
- PMA:
-
Premarket approval
- PtIr:
-
Platinum-iridium alloy
- RF:
-
Radio frequency
- RIE:
-
Reactive ion etching
- RTV:
-
Room temperature vulcanizing
- SIROF:
-
Sputtered iridium oxide
- SMD:
-
Surface mount devices
- SSED:
-
Summary of Safety and Effectiveness Data
- TRL:
-
Technology readiness level
- UEA:
-
Utah electrode array
- USP:
-
US Pharmacopeia
- WVTR:
-
Water vapor transmission rate
References
FDA Premarket Approval-PMA. https://www.fda.gov/medical-devices/premarket-submissions/premarket-approval-pma. Accessed 25 Aug 2020
EU-MDR. Medical Device Regulation (MDR): 2017/745/EC. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745 (2017). Accessed 25 Aug 2020
Chardack, W.M., Gage, A.A., Greatbatch, W.: A transistorized, self-contained, implantable pacemaker for the long-term correction of complete heart block. Surgery. 48, 643–654 (1960)
Larsson, B., Elmqvist, H., Rydén, L., et al.: Lessons from the first patient with an implanted pacemaker: 1958–2001. Pacing Clin. Electrophysiol. 26, 114–124 (2003). https://doi.org/10.1046/j.1460-9592.2003.00162.x
Stieglitz, T.: Integration of microfluidic capabilities into micromachined neural implants. Int. J. Micro-nano Scale Transp. 1, 139–158 (2010). https://doi.org/10.1260/1759-3093.1.2.139
Markewitz, A., Kronski, D., Kammeyer, A., et al.: Determinants of dual chamber pulse generators longevity. Pacing Clin. Electrophysiol. 18, 2116–2120 (1995). https://doi.org/10.1111/j.1540-8159.1995.tb04635.x
Stieglitz, T.: Of man and mice: translational research in Neurotechnology. Neuron. 105, 12–15 (2020). https://doi.org/10.1016/j.neuron.2019.11.030
Erhardt, J.B., Fuhrer, E., Gruschke, O.G., et al.: Should patients with brain implants undergo MRI? J. Neural Eng. 15, 41002 (2018). https://doi.org/10.1088/1741-2552/aab4e4
Eckmiller, R.: Learning retina implants with epiretinal contacts. Ophthalmic Res. 29, 281–289 (1997). https://doi.org/10.1159/000268026
Maynard, E.M.: Visual prostheses. Annu. Rev. Biomed. Eng. 3, 145–168 (2001). https://doi.org/10.1146/annurev.bioeng.3.1.145
Zrenner, E.: Will retinal implants restore vision? Science. 295, 1022–1025 (2002). https://doi.org/10.1126/science.1067996
Ayton, L.N., Barnes, N., Dagnelie, G., et al.: An update on retinal prostheses. Clin. Neurophysiol. 131, 1383–1398 (2020). https://doi.org/10.1016/j.clinph.2019.11.029
Nowik, K., Langwińska-Wośko, E., Skopiński, P., et al.: Bionic eye review – an update. J. Clin. Neurosci. (2020). https://doi.org/10.1016/j.jocn.2020.05.041
Roessler, G., Laube, T., Brockmann, C., et al.: Implantation and explantation of a wireless epiretinal retina implant device: observations during the EPIRET3 prospective clinical trial. Invest. Ophthalmol. Vis. Sci. 50, 3003–3008 (2009). https://doi.org/10.1167/iovs.08-2752
Stieglitz, T.: Development of a micromachined epiretinal vision prosthesis. J. Neural Eng. 6, 65005 (2009). https://doi.org/10.1088/1741-2560/6/6/065005
Stieglitz, T.: Manufacturing, assembling and packaging of miniaturized neural implants. Microsyst. Technol. 16, 723–734 (2010). https://doi.org/10.1007/s00542-009-0988-x
Stieglitz, T., Schuettler, M.: Implant interfaces. In: Inmann, A., Hodgins, D. (eds.) Implantable Sensor Systems for Medical Applications, pp. 39–67. Woodhead Publishing Limited, Cambridge, UK (2013)
Schuettler, M., Stieglitz, T.: Assembly and packaging. In: Inmann, A., Hodgins, D. (eds.) Implantable Sensor Systems for Medical Applications, pp. 108–149. Woodhead Publishing Limited, Cambridge, UK (2013)
Kim, S., Bhandari, R., Klein, M., et al.: Integrated wireless neural interface based on the Utah electrode array. Biomed. Microdevices. 11, 453–466 (2009). https://doi.org/10.1007/s10544-008-9251-y
Osenbach, F.W.: Water-induced corrosion of materials used for semiconductor passivation. J. Electrochem. Soc. 140, 3667–3675 (1993)
Thomas, R.W.: Moisture, myths, and microcircuits. IEEE Trans. Parts, Hybrids Packaging. PHP-12, 167–171 (1976)
Vogt, M., Hauptmann, R.: Plasma-deposited passivation layers for moisture and water protection. Surf. Coat. Technol. 74-75, 676–681 (1995). https://doi.org/10.1016/0257-8972(95)08268-9
Donaldson, P.E., Sayer, E.: Silicone-rubber adhesives as encapsulants for microelectronic implants; effect of high electric fields and of tensile stress. Med. Biol. Eng. Comput. 15, 712–715 (1977). https://doi.org/10.1007/bf02457937
Traeger, R.: Nonhermeticity of polymeric lid sealants. IEEE Trans. Parts, Hybrids Packaging. 13, 147–152 (1977)
Ripka, G., Harsanyi, G.: Electrochemical migration in thick-film IC-S. Electrocompon. Sci. Technol. 11, 281–290 (1985)
Lau, J.H. (ed.): Flip Chip Technologies Electronic packaging and interconnection series. McGraw Hill, New York (1996)
Edell, D.A.: Insulating biomaterials. In: Dhillon, G.S., Horch, K.W. (eds.) Neuroprosthetics: Theory and Practice. World Scientific Pub. Co, Singapore/Hackensack (2004)
Donaldson, P.E.K.: The essential role played by adhesion in the technology of neurological prostheses. Int. J. Adhes. Adhes. 16, 105–107 (1996). https://doi.org/10.1016/0143-7496(95)00031-3
Greenhouse, H. (ed.): Hermeticity of Electronic Packages. Noyes Publishers, Park Ridge (2000)
Licari, J.J., Enlow, L.R.: Hybrid Microcircuit Technology Handbook: Materials, Processes, Design, Testing and Production Materials Science and Process Technology Series, 2nd edn. Noyes Publications, Westwood (2010)
Ziaie, B., von Arx, J.A., Dokmeci, M.R., et al.: A hermetic glass-silicon micropackage with high-density on-chip feedthroughs for sensors and actuators. J. Microelectromech. Syst. 5, 166–179 (1996). https://doi.org/10.1109/84.536623
Zhou, D., Greenbaum, E.: Implantable Neural Prostheses 2: Techniques and Engineering Approaches. Biological and Medical Physics, Biomedical Engineering. Springer Science+Business Media LLC, New York (2010)
Schuettler, M., Ordonez, J.S., Silva Santisteban, T., et al.: Fabrication and test of a hermetic miniature implant package with 360 electrical feedthroughs. Conf. Proc. IEEE Eng. Med. Biol. Soc. 2010, 1585–1588 (2010). https://doi.org/10.1109/IEMBS.2010.5626677
Kohler, F., Gkogkidis, C.A., Bentler, C., et al.: Closed-loop interaction with the cerebral cortex: a review of wireless implant technology. Brain-Computer Interfaces. 4, 146–154 (2017). https://doi.org/10.1080/2326263X.2017.1338011
Guenther, T., Dodds, C.W.D., Lovell, N.H., et al.: Chip-scale hermetic feedthroughs for implantable bionics. Conf. Proc. IEEE Eng. Med. Biol. Soc. 2011, 6717–6720 (2011). https://doi.org/10.1109/IEMBS.2011.6091656
Ordonez, J.S., Schuettler, M., Ortmanns, M., et al.: A 232-channel retinal vision prosthesis with a miniaturized hermetic package. Conf. Proc. IEEE Eng. Med. Biol. Soc. 2012, 2796–2799 (2012). https://doi.org/10.1109/EMBC.2012.6346545
Kohler, F., Stieglitz, T., Schuettler, M.: Mechanical reliability of ceramic packages for active implantable medical devices – the IEC hammer test. Int. Symp. Microelectron. 2014, 319–324 (2014). https://doi.org/10.4071/isom-TP52
Schuettler, M., Schatz, A., Ordonez, J.S., et al.: Ensuring minimal humidity levels in hermetic implant housings. Conf. Proc. IEEE Eng. Med. Biol. Soc. 2011, 2296–2299 (2011). https://doi.org/10.1109/IEMBS.2011.6090578
Loeb, G.E., Peck, R.A., Moore, W.H., et al.: BION™ system for distributed neural prosthetic interfaces. Med. Eng. Phys. 23, 9–18 (2001). https://doi.org/10.1016/s1350-4533(01)00011-x
Cameron, T., Loeb, G.E., Peck, R.A., et al.: Micromodular implants to provide electrical stimulation of paralyzed muscles and limbs. I.E.E.E. Trans. Biomed. Eng. 44, 781–790 (1997). https://doi.org/10.1109/10.623047
Rudmann, L., Langenmair, M., Hahn, B., et al.: Novel desiccant-based very low humidity indicator for condition monitoring in miniaturized hermetic packages of active implants. Sensors Actuators B Chem., 128555 (2020). https://doi.org/10.1016/j.snb.2020.128555
Mackay, R.S.: Implanted transmitters and body fluid permeability. I.E.E.E. Trans. Biomed. Eng. BME-12, 198–199 (1965). https://doi.org/10.1109/TBME.1965.4502381
Ramachandran, A., Junk, M., Koch, K.P., et al.: A study of Parylene C polymer deposition inside microscale gaps. IEEE Trans. Adv. Packag. 30, 712–724 (2007). https://doi.org/10.1109/TADVP.2007.901662
Lovely, D.F., Olive, M.B., Scott, R.N.: Epoxy moulding system for the encapsulation of microelectronic devices suitable for implantation. Med. Biol. Eng. Comput. 24, 206–208 (1986). https://doi.org/10.1007/bf02443939
Hassler, C., Boretius, T., Stieglitz, T.: Polymers for neural implants. J. Polym. Sci. B Polym. Phys. 49, 18–33 (2011). https://doi.org/10.1002/polb.22169
Takmakov, P., Ruda, K., Scott Phillips, K., et al.: Rapid evaluation of the durability of cortical neural implants using accelerated aging with reactive oxygen species. J. Neural Eng. 12, 26003 (2015). https://doi.org/10.1088/1741-2560/12/2/026003
Donaldson, P.E.K.: Hydrothermal stability of joints, using a silicone rubber adhesive, for a range of adherents of interest to makers of surgically-implanted microelectronic devices. Int. J. Adhes. Adhes. 14, 103–107 (1994)
Loeb, G.E., Bak, M.J., Salcman, M., et al.: Parylene as a chronically stable, reproducible microelectrode insulator. I.E.E.E. Trans. Biomed. Eng. 24, 121–128 (1977). https://doi.org/10.1109/TBME.1977.326115
Rusu, L.-C., Ardelean, L.C., Jitariu, A.-A., et al.: An insight into the structural diversity and clinical applicability of polyurethanes in biomedicine. Polymers (Basel). 12 (2020). https://doi.org/10.3390/polym12051197
Pacheco, K.A.: Allergy to surgical implants. Clin. Rev. Allergy Immunol. 56, 72–85 (2019). https://doi.org/10.1007/s12016-018-8707-y
Skoet, R., Tollund, C., Bloch-Thomsen, P.E.: Epoxy contact dermatitis due to pacemaker compounds. Cardiology. 99, 112 (2003). https://doi.org/10.1159/000069721
DAVIES, J.G., SIDDONS, H.: Experience with implanted pacemakers: technical considerations. Thorax. 20, 128–134 (1965). https://doi.org/10.1136/thx.20.2.128
Fisher, J.D., Furman, S., Parker, B., et al.: Pacemaker failures characterized by continuous direct current leakage. Am. J. Cardiol. 37, 1019–1023 (1976). https://doi.org/10.1016/0002-9149(76)90418-5
Donaldson, P.E.K.: In search of the reliable microelectronic implant. Trends Neurosci. 1, 49–50 (1978). https://doi.org/10.1016/0166-2236(78)90019-X
Kenney, L.P.J., Hermens, H., Francis, D., et al.: Encapsulation materials for implantable FES systems – a case study. In: Sinkjær, T., Popović, D., Struijk, J.J. (eds.) Proceedings. Center for Sensory-Motor Interaction (SMI). Aalborg University, Aalborg (2000)
Love, C.J.: Cardiac Pacemakers and Defibrillators: Medical Handbook-Vademecum, 2nd edn. Landes Bioscience, Georgetown (2006)
Hassler, C., von Metzen, R.P., Ruther, P., et al.: Characterization of parylene C as an encapsulation material for implanted neural prostheses. J Biomed Mater Res Part B Appl Biomater. 93, 266–274 (2010). https://doi.org/10.1002/jbm.b.31584
Schanze, T., Hesse, L., Lau, C., et al.: An optically powered single-channel stimulation implant as test system for chronic biocompatibility and biostability of miniaturized retinal vision prostheses. I.E.E.E. Trans. Biomed. Eng. 54, 983–992 (2007). https://doi.org/10.1109/TBME.2007.895866
Finetech Medical Finetech-Brindley – Bladder Control System. https://finetech-medical.co.uk/products/finetech-brindley-bladder-control-system/. Accessed 10 Jul 2020
Donaldson, N., Baviskar, P., Cunningham, J., et al.: The permeability of silicone rubber to metal compounds: relevance to implanted devices. J. Biomed. Mater. Res. A. 100, 588–598 (2012). https://doi.org/10.1002/jbm.a.33257
Ardebili, H., Pecht, M.: Encapsulation Technologies for Electronic Applications. Materials and Processes for Electronic Applications Series. William Andrew, Oxford (2009)
Bouton, C.: Cracking the neural code, treating paralysis and the future of bioelectronic medicine. J. Intern. Med. 282, 37–45 (2017). https://doi.org/10.1111/joim.12610
Govaerts, J., Christiaens, W., Bosman, E., et al.: Fabrication processes for embedding thin chips in flat flexible substrates. IEEE Trans. Adv. Packag. 32, 77–83 (2009). https://doi.org/10.1109/TADVP.2008.2005838
Burghartz, J.: Ultra-Thin Chip Technology and Applications. Springer Science+Business Media LLC, New York (2011)
Abdulagatov, A.I., Yan, Y., Cooper, J.R., et al.: Al2O3 and TiO2 atomic layer deposition on copper for water corrosion resistance. ACS Appl. Mater. Interfaces. 3, 4593–4601 (2011). https://doi.org/10.1021/am2009579
Choi, H., Lee, S., Jung, H., et al.: Moisture barrier properties of Al 2 O 3 films deposited by remote plasma atomic layer deposition at low temperatures. Jpn. J. Appl. Phys. 52, 35502 (2013). https://doi.org/10.7567/JJAP.52.035502
Schaubroeck, D., Verplancke, R., Cauwe, M., et al.: Polyimide-ald-polyimide layers as hermetic encapsulant for implants. Presented at the XXXI international conference on surface modification technologies (SMT31), pp. 1–6 (2017)
Jeong, J., Laiwalla, F., Lee, J., et al.: Conformal hermetic sealing of wireless microelectronic implantable Chiplets by multilayered atomic layer deposition (ALD). Adv. Funct. Mater. 1806440 (2018). https://doi.org/10.1002/adfm.201806440
Lee, J., Laiwalla, F., Jeong, J., et al.: Wireless power and data link for ensembles of sub-mm scale implantable sensors near 1GHz. In: 2018 IEEE Biomedical Circuits and Systems Conference (BioCAS), pp 1–4. IEEE, Piscataway, NJ (USA) (2018). https://doi.org/10.1109/BIOCAS.2018.8584725
Neely, R.M., Piech, D.K., Santacruz, S.R., et al.: Recent advances in neural dust: towards a neural interface platform. Curr. Opin. Neurobiol. 50, 64–71 (2018). https://doi.org/10.1016/j.conb.2017.12.010
Minnikanti, S., Diao, G., Pancrazio, J.J., et al.: Lifetime assessment of atomic-layer-deposited Al2O3-Parylene C bilayer coating for neural interfaces using accelerated age testing and electrochemical characterization. Acta Biomater. 10, 960–967 (2014). https://doi.org/10.1016/j.actbio.2013.10.031
Donaldson, P.E.: Aspects of silicone rubber as an encapsulant for neurological prostheses. Part 1. Osmosis. Med. Biol. Eng. Comput. 29, 34–39 (1991). https://doi.org/10.1007/BF02446293
Mackay, R.S.: Bio-Medical Telemetry: Sensing and Transmitting Biological Information from Animals and Man, 2nd edn. IEEE Press, New York (1993)
Ko, W.H., Spear, T.M.: Packaging materials and techniques for implantable instruments. IEEE Eng. Med. Biol. Mag. 2, 24–38 (1983). https://doi.org/10.1109/EMB-M.1983.5005879
Donaldson, P.E., Sayer, E.: A vacuum centrifuge for void-free potting of implantable hybrid microcircuits in silicone. Med. Biol. Eng. 13, 595–596 (1975). https://doi.org/10.1007/BF02477144
Koch, J., Schuettler, M., Pasluosta, C., et al.: Electrical connectors for neural implants: design, state of the art and future challenges of an underestimated component. J. Neural Eng. 16, 61002 (2019). https://doi.org/10.1088/1741-2552/ab36df
Mills, J.O., Jalil, A., Stanga, P.E.: Electronic retinal implants and artificial vision: journey and present. Eye (Lond.). 31, 1383–1398 (2017). https://doi.org/10.1038/eye.2017.65
Daly, J.J., Wolpaw, J.R.: Brain–computer interfaces in neurological rehabilitation. Lancet Neurol. 7, 1032–1043 (2008). https://doi.org/10.1016/S1474-4422(08)70223-0
Raspopovic, S., Capogrosso, M., Petrini, F.M., et al.: Restoring natural sensory feedback in real-time bidirectional hand prostheses. Sci. Transl. Med. 6, 222ra19 (2014). https://doi.org/10.1126/scitranslmed.3006820
Petrini, F.M., Bumbasirevic, M., Valle, G., et al.: Sensory feedback restoration in leg amputees improves walking speed, metabolic cost and phantom pain. Nat. Med. 25, 1356–1363 (2019). https://doi.org/10.1038/s41591-019-0567-3
Petrini, F.M., Valle, G., Bumbasirevic, M., et al.: Enhancing functional abilities and cognitive integration of the lower limb prosthesis. Sci. Transl. Med. 11 (2019). https://doi.org/10.1126/scitranslmed.aav8939
Tan, D.W., Schiefer, M.A., Keith, M.W., et al.: A neural interface provides long-term stable natural touch perception. Sci. Transl. Med. 6, 257ra138 (2014). https://doi.org/10.1126/scitranslmed.3008669
Hochberg, L.R., Serruya, M.D., Friehs, G.M., et al.: Neuronal ensemble control of prosthetic devices by a human with tetraplegia. Nature. 442, 164–171 (2006). https://doi.org/10.1038/nature04970
Donaldson, P.E.: The Cooper cable: an implantable multiconductor cable for neurological prostheses. Med. Biol. Eng. Comput. 21, 371–374 (1983). https://doi.org/10.1007/BF02478508
Stieglitz, T., Schuettler, M., Rubehn, B., et al.: Evaluation of polyimide as substrate material for electrodes to interface the peripheral nervous system. In: 2011 5th International IEEE/EMBS Conference on Neural Engineering, pp. 529–533. IEEE (2011). https://doi.org/10.1109/NER.2011.5910602
Petrini, F.M., Valle, G., Strauss, I., et al.: Six-month assessment of a hand prosthesis with intraneural tactile feedback. Ann. Neurol. 85, 137–154 (2019). https://doi.org/10.1002/ana.25384
Robinson, J.T., Pohlmeyer, E., Gather, M.C., et al.: Developing next-generation brain sensing technologies – a review. IEEE Sensors J. 19 (2019). https://doi.org/10.1109/jsen.2019.2931159
US FDA CDRH. Summary of safety and probable benefit: medtronic Reclaim™ DBS therapy for OCD (H050003). https://www.accessdata.fda.gov/cdrh_docs/pdf5/H050003b.pdf (2009). Accessed 24 Aug 2020
US FDA CDRH. Summary of safety and effectiveness data: brio neurostimulation system (P140009). https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140009b.pdf (2015). Accessed 24 Aug 2020
NeuroPace I. 2017 RNS® system user manual: DN 1017337
US FDA CDRH. Summary of safety and effectiveness data: Algovita™ Spinal Cord Stimulation (SCS) system (P130028). https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130028b.pdf (2015). Accessed 24 Aug 2020
US FDA CDRH 2015. Summary of safety and effectiveness data: Senza Spinal Cord Stimulation (SCS) system (P130022). https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130022b.pdf (2020)
US FDA CDRH. Summary of safety and effectiveness data: RNS® system (P100026). https://www.accessdata.fda.gov/cdrh_docs/pdf10/p100026b.pdf (2013). Accessed 24 Aug 2020
IEC. IEC 62366–1 2015 medical devices – Part 1: application of usability engineering to medical devices. International Organization for Standardization, Geneva, Switzerland (2015)
US FDA and HHS. Code of federal regulations 21 – food and drugs. Part 820. Food and Drug Administration, Silver Spring, MD (USA) (2019)
U.S. HHS, FDA and CDRH. Applying human factors and usability engineering to medical devices-guidance. Food and Drug Administration, Silver Spring, MD (USA) (2016)
Schüttler, M.: Dreidimensionale Formgebung von planaren Mikroelektroden zur Optimierung der Signalableitung und Stimulation am peripheren Nerven. Dissertation, Zugl.: Saarbrücken, University. Fraunhofer-IRB-Verl., Stuttgart (2002)
Letechipia, J.E., Peckham, P.H., Gazdik, M., et al.: In-line lead connector for use with implanted neuroprosthesis. I.E.E.E. Trans. Biomed. Eng. 38, 707–709 (1991). https://doi.org/10.1109/10.83572
Mond, H.G., Helland, J.R., Fischer, A.: The evolution of the cardiac implantable electronic device connector. Pacing Clin. Electrophysiol. 36, 1434–1446 (2013). https://doi.org/10.1111/pace.12211
Le Pimpec-Barthes, F., Gonzalez-Bermejo, J., Hubsch, J.-P., et al.: Intrathoracic phrenic pacing: a 10-year experience in France. J. Thorac. Cardiovasc. Surg. 142, 378–383 (2011). https://doi.org/10.1016/j.jtcvs.2011.04.033
Bhadra, N., Kilgore, K.L., Peckham, P.H.: Implanted stimulators for restoration of function in spinal cord injury. Med. Eng. Phys. 23, 19–28 (2001). https://doi.org/10.1016/s1350-4533(01)00012-1
Schuettler, M., Stiess, S., King, B.V., et al.: Fabrication of implantable microelectrode arrays by laser cutting of silicone rubber and platinum foil. J. Neural Eng. 2, S121–S128 (2005). https://doi.org/10.1088/1741-2560/2/1/013
Green, R.A., Ordonez, J.S., Schuettler, M., et al.: Cytotoxicity of implantable microelectrode arrays produced by laser micromachining. Biomaterials. 31, 886–893 (2010). https://doi.org/10.1016/j.biomaterials.2009.09.099
Henle, C., Raab, M., Cordeiro, J.G., et al.: First long term in vivo study on subdurally implanted micro-ECoG electrodes, manufactured with a novel laser technology. Biomed. Microdevices. 13, 59–68 (2011). https://doi.org/10.1007/s10544-010-9471-9
Ordonez, J.S., Pikov, V., Wiggins, H., et al.: Cuff electrodes for very small diameter nerves – prototyping and first recordings in vivo. Conf. Proc. IEEE Eng. Med. Biol. Soc. 2014, 6846–6849 (2014). https://doi.org/10.1109/EMBC.2014.6945201
Henle, C., Hassler, C., Kohler, F., et al.: Mechanical characterization of neural electrodes based on PDMS-parylene C-PDMS sandwiched system. Conf. Proc. IEEE Eng. Med. Biol. Soc. 2011, 640–643 (2011). https://doi.org/10.1109/IEMBS.2011.6090142
FDA. AirRay subdural cortical electrodes. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183437 (2019). Accessed 25 Aug 2020
Navarro, X., Krueger, T.B., Lago, N., et al.: A critical review of interfaces with the peripheral nervous system for the control of neuroprostheses and hybrid bionic systems. J. Peripher. Nerv. Syst. 10, 229–258 (2005). https://doi.org/10.1111/j.1085-9489.2005.10303.x
Wise, K.D., Anderson, D.J., Hetke, J.F., et al.: Wireless implantable microsystems: high-density electronic interfaces to the nervous system. Proc. IEEE. 92, 76–97 (2004). https://doi.org/10.1109/JPROC.2003.820544
Ruther, P., Paul, O.: New approaches for CMOS-based devices for large-scale neural recording. Curr. Opin. Neurobiol. 32, 31–37 (2015). https://doi.org/10.1016/j.conb.2014.10.007
Patil, A.C., Thakor, N.V.: Implantable neurotechnologies: a review of micro- and nanoelectrodes for neural recording. Med. Biol. Eng. Comput. 54, 23–44 (2016). https://doi.org/10.1007/s11517-015-1430-4
Tang, L.-J., Wang, M.-H., Tian, H.-C., et al.: Progress in research of flexible MEMS microelectrodes for neural Interface. Micromachines (Basel). 8 (2017). https://doi.org/10.3390/mi8090281
Won, S.M., Song, E., Zhao, J., et al.: Recent advances in materials, devices, and systems for neural interfaces. Adv. Mater. Weinheim. 30, e1800534 (2018). https://doi.org/10.1002/adma.201800534
Wise, K.D., Angell, J.B., Starr, A.: An integrated-circuit approach to extracellular microelectrodes. I.E.E.E. Trans. Biomed. Eng. 17, 238–247 (1970). https://doi.org/10.1109/tbme.1970.4502738
Bai, Q., Wise, K.D., Anderson, D.J.: A high-yield microassembly structure for three-dimensional microelectrode arrays. I.E.E.E. Trans. Biomed. Eng. 47, 281–289 (2000). https://doi.org/10.1109/10.827288
Najafi, K., Wise, K.D.: An implantable multielectrode array with on-chip signal processing. IEEE J. Solid State Circuits. 21, 1035–1044 (1986). https://doi.org/10.1109/JSSC.1986.1052646
Kisban, S., Herwik, S., Seidl, K., et al.: Microprobe array with low impedance electrodes and highly flexible polyimide cables for acute neural recording. Conf. Proc. IEEE Eng. Med. Biol. Soc. 2007, 175–178 (2007). https://doi.org/10.1109/IEMBS.2007.4352251
Torfs, T., Aarts, A.A.A., Erismis, M.A., et al.: Two-dimensional multi-channel neural probes with electronic depth control. IEEE Trans. Biomed. Circuits Syst. 5, 403–412 (2011). https://doi.org/10.1109/TBCAS.2011.2162840
Campbell, P.K., Jones, K.E., Huber, R.J., et al.: A silicon-based, three-dimensional neural interface: manufacturing processes for an intracortical electrode array. I.E.E.E. Trans. Biomed. Eng. 38, 758–768 (1991). https://doi.org/10.1109/10.83588
Brandman, D.M., Cash, S.S., Hochberg, L.R.: Review: human intracortical recording and neural decoding for brain-computer interfaces. IEEE Trans. Neural Syst. Rehabil. Eng. 25, 1687–1696 (2017). https://doi.org/10.1109/TNSRE.2017.2677443
Hochberg, L.R., Bacher, D., Jarosiewicz, B., et al.: Reach and grasp by people with tetraplegia using a neurally controlled robotic arm. Nature. 485, 372–375 (2012). https://doi.org/10.1038/nature11076
Barrese, J.C., Aceros, J., Donoghue, J.P.: Scanning electron microscopy of chronically implanted intracortical microelectrode arrays in non-human primates. J. Neural Eng. 13, 26003 (2016). https://doi.org/10.1088/1741-2560/13/2/026003
Barrese, J.C., Rao, N., Paroo, K., et al.: Failure mode analysis of silicon-based intracortical microelectrode arrays in non-human primates. J. Neural Eng. 10, 66014 (2013). https://doi.org/10.1088/1741-2560/10/6/066014
Ordonez, J., Schuettler, M., Boehler, C., et al.: Thin films and microelectrode arrays for neuroprosthetics. MRS Bull. 37, 590–598 (2012). https://doi.org/10.1557/mrs.2012.117
Rubehn, B., Bosman, C., Oostenveld, R., et al.: A MEMS-based flexible multichannel ECoG-electrode array. J. Neural Eng. 6, 36003 (2009). https://doi.org/10.1088/1741-2560/6/3/036003
Čvančara, P., Boretius, T., López-Álvarez, V.M., et al.: Stability of flexible thin-film metallization stimulation electrodes: analysis of explants after first-in-human study and improvement of in vivo performance. J. Neural Eng. 17, 46006 (2020). https://doi.org/10.1088/1741-2552/ab9a9a
Stieglitz, T., Beutel, H., Schuettler, M., et al.: Micromachined, polyimide-based devices for flexible nueral interfaces. Biomed. Microdevices. 2, 283–294 (2000). https://doi.org/10.1023/A:1009955222114
Cheung, K.C., Renaud, P., Tanila, H., et al.: Flexible polyimide microelectrode array for in vivo recordings and current source density analysis. Biosens. Bioelectron. 22, 1783–1790 (2007). https://doi.org/10.1016/j.bios.2006.08.035
Bockhorst, T., Pieper, F., Engler, G., et al.: Synchrony surfacing: epicortical recording of correlated action potentials. Eur. J. Neurosci. 48, 3583–3596 (2018). https://doi.org/10.1111/ejn.14167
Bosman, C.A., Schoffelen, J.-M., Brunet, N., et al.: Attentional stimulus selection through selective synchronization between monkey visual areas. Neuron. 75, 875–888 (2012). https://doi.org/10.1016/j.neuron.2012.06.037
Badia, J., Boretius, T., Pascual-Font, A., et al.: Biocompatibility of chronically implanted transverse intrafascicular multichannel electrode (TIME) in the rat sciatic nerve. I.E.E.E. Trans. Biomed. Eng. 58 (2011). https://doi.org/10.1109/TBME.2011.2153850
La Oliva N de, Navarro, X., Del Valle, J.: Time course study of long-term biocompatibility and foreign body reaction to intraneural polyimide-based implants. J. Biomed. Mater. Res. A. 106, 746–757 (2018). https://doi.org/10.1002/jbm.a.36274
Vomero, M., Porto Cruz, M.F., Zucchini, E., et al.: Conformable polyimide-based μECoGs: bringing the electrodes closer to the signal source. Biomaterials. 255, 120178 (2020). https://doi.org/10.1016/j.biomaterials.2020.120178
Nature: Method of the year 2010. Nat. Methods. 8, 1 (2011). https://doi.org/10.1038/nmeth.f.321
Alt, M.T., Fiedler, E., Rudmann, L., et al.: Let there be light – Optoprobes for neural implants. Proc. IEEE. 105, 101–138 (2017). https://doi.org/10.1109/JPROC.2016.2577518
Rudmann, L., Alt, M.T., Ashouri Vajari, D., et al.: Integrated optoelectronic microprobes. Curr. Opin. Neurobiol. 50, 72–82 (2018). https://doi.org/10.1016/j.conb.2018.01.010
Son, Y., Lee, H.J., Kim, J., et al.: In vivo optical modulation of neural signals using monolithically integrated two-dimensional neural probe arrays. Sci. Rep. 5, 15466 (2015). https://doi.org/10.1038/srep15466
Wu, F., Stark, E., Ku, P.-C., et al.: Monolithically integrated μLEDs on silicon neural probes for high-resolution Optogenetic studies in behaving animals. Neuron. 88, 1136–1148 (2015). https://doi.org/10.1016/j.neuron.2015.10.032
Seo, D., Neely, R.M., Shen, K., et al.: Wireless recording in the peripheral nervous system with ultrasonic neural dust. Neuron. 91, 529–539 (2016). https://doi.org/10.1016/j.neuron.2016.06.034
Luan, L., Wei, X., Zhao, Z., et al.: Ultraflexible nanoelectronic probes form reliable, glial scar-free neural integration. Sci. Adv. 3, e1601966 (2017). https://doi.org/10.1126/sciadv.1601966
Goding, J., Vallejo-Giraldo, C., Syed, O., et al.: Considerations for hydrogel applications to neural bioelectronics. J. Mater. Chem. B. 7, 1625–1636 (2019). https://doi.org/10.1039/c8tb02763c
Kang, S.-K., Murphy, R.K.J., Hwang, S.-W., et al.: Bioresorbable silicon electronic sensors for the brain. Nature. 530, 71–76 (2016). https://doi.org/10.1038/nature16492
EU. Technology readiness levels (TRL); Extract from Part 19 – Commission Decision C (2014)4995. https://ec.europa.eu/research/participants/data/ref/h2020/wp/2014_2015/annexes/h2020-wp1415-annex-g-trl_en.pdf (2014). Accessed 27 Mar 2020
Osawa, Y., Miyazaki, K.: An empirical analysis of the valley of death: large-scale R&D project performance in a Japanese diversified company. Asian J. Technol. Innov. 14, 93–116 (2006). https://doi.org/10.1080/19761597.2006.9668620
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Section Editor information
Rights and permissions
Copyright information
© 2021 Springer Nature Singapore Pte Ltd.
About this entry
Cite this entry
Stieglitz, T. (2021). Implantable Device Fabrication and Packaging. In: Thakor, N.V. (eds) Handbook of Neuroengineering. Springer, Singapore. https://doi.org/10.1007/978-981-15-2848-4_102-1
Download citation
DOI: https://doi.org/10.1007/978-981-15-2848-4_102-1
Received:
Accepted:
Published:
Publisher Name: Springer, Singapore
Print ISBN: 978-981-15-2848-4
Online ISBN: 978-981-15-2848-4
eBook Packages: Springer Reference EngineeringReference Module Computer Science and Engineering