Technology Advances and Challenges in Hermetic Packaging for Implantable Medical Devices

  • Guangqiang Jiang
  • David D. Zhou
Part of the Biological and Medical Physics, Biomedical Engineering book series (BIOMEDICAL)


Many implantable medical devices contain sophisticated electronic circuits. Hermetic packaging is required to provide the implant’s electronic circuitry with protection from the harsh environment of the human body. This chapter provides a review of available hermetic sealing methods and their applications. General considerations of implantable medical device packaging are discussed. Various testing methods applicable to the packaging of implantable medical devices are also presented. Many issues associated with hermetic packaging are not yet completely understood, nor are any corresponding difficulties completely overcome. The continued miniaturization of future implantable medical devices provides both opportunities and challenges for packaging/materials engineers to improve the existing packaging methods, and to develop new methods. Reliable hermetic micropackaging technologies are the key to a wide utilization of microelectromechanical systems (MEMS) in miniaturized implantable medical devices.


Laser Welding Cochlear Implant Metal Package Accelerate Life Testing Implantable Medical Device 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



The authors would like to thank the Alfred Mann Foundation and Second Sight Medical Product Inc. for their support while they were working on this manuscript. They also thank Dr. Schnittgrund G, Dr. Duttaahmed S, and Grannis S for their detailed review of the manuscript.


  1. 1.
    FDA Consumer (2000) 34(2):7Google Scholar
  2. 2.
    Thwaites T (1995) Total recall for medical implants: New Scientist, p. 1212Google Scholar
  3. 3.
    Tummala R, Rymaszewski E (1989) Microelectronics packaging handbook, New York, Van Nostrand ReinholdGoogle Scholar
  4. 4.
    Ely K (2000) Manufacturing issues in hermetic sealing of medical products, Accessed 20 Jan 2008
  5. 5.
    Bhadra N, Kilgore KL and Peckham PH (2001) Implanted stimulators for restoration of function in spinal cord injury, Medical Engineering and Physics. 23:19–28CrossRefGoogle Scholar
  6. 6.
    Strojnik P, Peckham PH (2006) Implantable stimulators for neuromuscular control. In: Bronzino JD (ed) Medical devices and systems, The biomedical engineering handbook, 3rd edn. CRC Press, Taylor and Francis Group, Boca Raton, FLGoogle Scholar
  7. 7.
    Nichols M F (1994) The challenges for hermetic encapsulation of implanted devices- A review, Biomed. Eng. 22(1): 39–67MathSciNetGoogle Scholar
  8. 8.
    Lussignea RW (1997) Liquid crystal polymers: new barrier materials for packaging, Packaging Technology, October 1997Google Scholar
  9. 9.
    Farrell B, Jaynes P, Johnson W et al. (2003) The liquid crystal polymer packaging solution, Proc. IMAPS 2003 International Symposium, Boston, MA pp 18–23Google Scholar
  10. 10.
    Loeb GE, Byers CL, Rebscher SJ et al. (1983) Design and fabrication of an experimental cochlear prosthesis. Med & Biol Eng Comput, 21:241–254CrossRefGoogle Scholar
  11. 11.
    Forde M, Ridgely P (2006) Implantable cardiac pacemakers. In: Bronzino JD (ed) Medical Devices and Systems, The Biomed Eng handbook, 3rd edn. CRC Press, Taylor and Francis Group, Boca Raton, FLGoogle Scholar
  12. 12.
    Duffin EG (2006) Implantable defibrillator. In: Bronzino JD (ed) Medical Devices and Systems, The Biomed Eng handbook, 3rd edn. CRC Press, Taylor and Francis Group, Boca Raton, FLGoogle Scholar
  13. 13.
    McDermott H (1989) An advanced multiple channel cochlear implant. Biomedical Engineering, IEEE Transactions on. 36:789–797CrossRefGoogle Scholar
  14. 14.
    Loeb GE, Richmond FJR (2001) BION™ implants for therapeutic and functional electrical stimulation. In: Chapin JK, Moxon KA (ed) Neural prostheses for restoration of sensory and motor function. CRC Press, Boca Raton, FLGoogle Scholar
  15. 15.
    Jiang G (2005) Development of ceramic-to-metal package for BION microstimulator, Ph.D. dissertation, University of Southern CaliforniaGoogle Scholar
  16. 16.
    Hochmair I, Nopp P, Jolly C et al. (2006) Trends in Amplification, 10 (4):201–220Google Scholar
  17. 17.
    Weiland JD, Liu W, Humayun MS (2005) Retinal Prosthesis, Annu. Rev. Biomed. Eng. 7:361–401CrossRefGoogle Scholar
  18. 18.
    McKinney JRV, Lemons J (1987) The dental implant, PSG Publ., Littleton, MAGoogle Scholar
  19. 19.
    Hulbert SF, Bokros JC, Hench LL et al. (1987) Ceramics in clinical applications: Past, present, and future, in High Tech Ceramics, Vincenzini P ed, Elsevier, Amsterdam, pp189–213Google Scholar
  20. 20.
    Christel P, Meunier A, Dorlot JM et al. (1988) Biomechanical compatibility and design of ceramic implants for orthopedic surgery, in Bioceramics: materials characteristics versus in-vivo behavior. Ducheyne P and Lemons J, eds. Ann New York Acad Sci 523:234Google Scholar
  21. 21.
    Hulbert S (1993) The use of alumina and zirconia in surgical implants. In: An introduction to bioceramics. Hench LL and Wilson J, eds. World Scientific, Singapore, P25–40Google Scholar
  22. 22.
    Miller JA, Talton JD, Bhatia S (1996) in Clinical performance of skeletal prostheses, Hench LL, Wilson J eds, Chapman and hall, London, p41–56Google Scholar
  23. 23.
    Piconi C, Maccauro G (1999) Review: zirconia as a ceramic biomaterial. Biomatls 20:1–25CrossRefGoogle Scholar
  24. 24.
    Tsukuma K, Shimada M (1985) Strength, fracture toughness and vickers hardness of CeO2-stabilized tetragonal ZrO2 polycrystals (Ce-TZP). J of Matls Sci 20:1178–1184CrossRefGoogle Scholar
  25. 25.
    Schneider SJ (ed) (1991) Ceramics and glasses In: Engineered Materials Handbook, Volume 4, ASM InternationalGoogle Scholar
  26. 26.
    Schwartz MM (1992) Handbook of structural ceramics, McGraw-Hill Publishers, USAGoogle Scholar
  27. 27.
    Guillou MO, Henshall JL, Hooper RM et al. (1992) Indentation fracture testing and analysis, and its application to zirconia, silicon carbide and silicon nitride ceramics. J of Hard Matls 3:421–434Google Scholar
  28. 28.
    Whitney ED (1994) Ceramic cutting tools – materials, development and performance, Noyes Publications, Park Ridge, NJGoogle Scholar
  29. 29.
    Griffin EA, Mumm DR, Marshall DB (1996) Rapid prototyping of functional ceramic composites. Amer Ceram Soc Bull 75:65–68Google Scholar
  30. 30.
    Jiang G, Mishler D, Davis R et al. (2005) Zirconia to Ti-6Al-4 V braze joint for implantable biomedical device. J of Biomed Mater Res: Part B – Applied Biomatls 72B:316–321CrossRefGoogle Scholar
  31. 31.
    Daulton J (2006) Self-centering braze assembly, US patent: 7,132,173 B2Google Scholar
  32. 32.
    Haller MI, He TX, Daulton J (2006) Electrode assembly for a microstimulator, US patent: 7,103,408 B2Google Scholar
  33. 33.
    Loeb GE, Richmond FJR, Baker LL (2006) The BION devices: injectable interfaces with peripheral nerves and muscles, Neurosurg Focus 20 (5):E2Google Scholar
  34. 34.
    Webster JG (1978) Medical instrumentation application and design, Houghton Mifflin, BostonGoogle Scholar
  35. 35.
    Williams DF (1981) Biocompatibility of clinical implant materials, Vols 1 and 2, CRC press, Boca Raton, FLGoogle Scholar
  36. 36.
    Thomas RW (1976) Moisture, myths, and microcircuits, in IEEE Trans. On Parts, Hybrids, and Packaging, p167–171Google Scholar
  37. 37.
    DerMarderosian A (1978) Electrochemical migration of metals, Proc. Int’l Microelectronics Symp., pp134–141Google Scholar
  38. 38.
    Grunthaner FJ, Griswold TW, Clendening PJ (1975) Migratory gold resistive shorts: chemical aspects of a failure mechanism, Proc. 13th annual proceedings. International reliability physics symposium, pp 99–106Google Scholar
  39. 39.
    DerMarderosian A, Murphy C (1977) Humidity threshold variations for dendritic growth on hybrid substrate, Proc Int Reliability Phys Symp, Las Vegas, NVGoogle Scholar
  40. 40.
    Roswell AE, Clymer GK (1971) Thermal fatigue lead-soldered semiconductor device, US Patent 3,735,208Google Scholar
  41. 41.
    Greenhouse H (1999) Hermeticity of electronic packages, Noyes Publication / William Andrew Publishing LLC, Norwich, New York, USAGoogle Scholar
  42. 42.
    Wong CP (1998) Polymers for encapsulation: materials processes and reliability, Chip scale review, Vol. 2, No. 1, 30Google Scholar
  43. 43.
    Donaldson PEK (1983) The cooper cable: an implantable multiconductor cable for neurological prostheses. J of medical and biological engineering and computing 21:371–374CrossRefGoogle Scholar
  44. 44.
    Lovely DF, Olive MB, Scott RN (1986) Epoxy moulding system for the encapsulation of microelectronic devices suitable for implantation, J. of medical and biological engineering and computing, Vol24, No. 2:206–208CrossRefGoogle Scholar
  45. 45.
    Loeb GE, Bak MJ, Salcman M et al. (1977) Parylene as a chronically stable, reproducible microelectrode insulator, IEEE Trans. Biomed. Eng., 24 (2):121–128CrossRefGoogle Scholar
  46. 46.
    Yuen TG, Agnew WF, Bullara LA (1987) Tissue response to potential neuro-prosthetic material implanted subdurally. Biomaterials, 8 (2):138–141CrossRefGoogle Scholar
  47. 47.
    Stieglitz T (2005) Methods to determine the stability of polymer encapsulations. The 10th annual conference of the international functional electrical stimulation society, Montréal, CanadaGoogle Scholar
  48. 48.
    Donaldson PEK (1976) The encapsulation of microelectronic devices for long service life. IEEE trans. Biomed. Eng., 23:281–285CrossRefGoogle Scholar
  49. 49.
    Petersen ME, Sergent J (1979) Metal hermetic package selection, Electronic Packaging and Production, p. 150–156Google Scholar
  50. 50.
    Graeme C (2003) Cochlear implants, fundamentals and applications, AIP series in modern acoustics and signal processing by Beyer RT (editor in chief) Springer, New YorkGoogle Scholar
  51. 51.
    Bealka JD, Da Costa PH (2003) Feedthrough devices, US patent: 6,586,675 B1Google Scholar
  52. 52.
    Mastrogiacomo J (2007) New ceramic technology contributes to advances in medical implants, Accessed 20 Jan 2008
  53. 53.
    Peytour C, Berthet P, Barbier F et al. (1990) Interface microstructure and mechanical behavior of brazed Ti6Al4V/zirconia joints, J. Mater. Sci. Lett, 9:1129–31CrossRefGoogle Scholar
  54. 54.
    Santella ML, Pak JJ (1993) Brazing titanium-vapor-coated zirconia. Welding Res Supplement, 165–172Google Scholar
  55. 55.
    Agathopoulos S, Moretto P, Peteves SD et al. (1997) Brazing of zirconia to Ti and Ti6Al4V. In 1996 Amer Ceram. Soc. Meeting, Indianapolis, USA 1996, Ceram Joining, Ceram Trans. Indianapolis 77:75–82Google Scholar
  56. 56.
    Lasater BJ (2001) Methods for hermetically sealing ceramic to metallic surfaces and assemblies incorporating such seal, US Patent: 6,221,513 B1Google Scholar
  57. 57.
    Fey K and Jiang G (2003) Application and manufacturing method for a ceramic to metal seal; US Patent: 6,521,350 B2Google Scholar
  58. 58.
    Messler RW (2004) Joining of materials and structures-–from pragmatic process to enabling technology, Elsevier Butterworth Heinemann, Burlington, MAGoogle Scholar
  59. 59.
    Correia RN, Emiliano JV, Moretto P (1998) Microstructure of diffusional zirconia-titanium and zirconia-Ti6Al4V alloy joints. J Matl Sci 33:215–221CrossRefGoogle Scholar
  60. 60.
    Agathopoulos S, Correia RN, Joanni E et al. (2002) Interactions at zirconia-Au-Ti interfaces at high temperatures, Key Eng Matls 206–213:487–90.CrossRefGoogle Scholar
  61. 61.
    Messler RW (1993) Joining of advanced materials, Elsevier Butterworth Heinemann Science, Burlington, MAGoogle Scholar
  62. 62.
    Agathopoulos S, Pina S, Correia RN (2002) A review of recent investigations on zirconia joining for biomedical applications. Ceram Trans 138:35–147Google Scholar
  63. 63.
    Falvo A, Furgiuele FM, Maletta C (2005) Laser welding of a NiTi alloy: Mechanical and shape memory behavior. Materials Science and Engineering: A. 412:235–240CrossRefGoogle Scholar
  64. 64.
    Wu MH (2001) Fabrication of Nitinol materials and components, Proceedings of the international conference on shape memory and super-elastic technologies, Kunming, China, 285–292Google Scholar
  65. 65.
    Schetky LM, Wu MH (2003) Issues in the further development of Nitinol properties and processing for medical device applications, Proceedings from the Materials & Processes for Medical Devices Conference, Anaheim, California, pp 271–276Google Scholar
  66. 66.
    Korinko PS, Malene SH (2001) Considerations for the weldability of types 304 L and 316 L stainless steel. J of failure analysis and prevention 1:61–68.Google Scholar
  67. 67.
    Greenberg RJ, Mann AE, Talbot N et al. (2007) Biocompatible bonding method and electronics package suitable for implantation, US Patent: 7,211,103Google Scholar
  68. 68.
    Loeb GE, Zamin CJ, Schulman JH et al. (1991) Injectable microstimulator for functional electrical stimulation, North Sea Conference on Biomedical Engineering, Antwerp, BelgiumGoogle Scholar
  69. 69.
    Singh J,  Peck RA, Loeb GE (2001) Development of BION Technology for functional electrical stimulation: Hermetic Packaging, Proc. IEEE-EMBS Istanbul, TurkeyGoogle Scholar
  70. 70.
    Dupont AC,  Bagg SD, Chun S et al. (2002) Clinical Trials of BION™ Microstimulators, Proc. IFESS, Ljubljana, SloveniaGoogle Scholar
  71. 71.
    Loeb GE, Peck RA, Singh J et al. (2006) Mechanical loading of rigid intramuscular implants, Biomed microdevices, Vol . 9, No. 6:901–910CrossRefGoogle Scholar
  72. 72.
    ASM International (1989) Electronic material handbook, Packaging Vol. 1, CRC pressGoogle Scholar
  73. 73.
    Ligtvoet KM, Wijcherson A, Bakker EJ (2005) Biocompatibility of medical devices, In: DI Sens symposium-bookGoogle Scholar
  74. 74.
    Mansfeld F (2003) The use of electrochemical techniques for the investigation and monitoring of microbiologically influenced corrosion and its inhibition – a review. Materials and Corrosion 54:489–502CrossRefGoogle Scholar
  75. 75.
    Chohayeb AA, Fraker AC, Eichmiller FC et al. (1996) Corrosion Behavior of Dental Casting Alloys Coupled with Titanium, in Medical Applications of Titanium and Its Alloys: The Material and Biological Issues, ASTM STP 1272, S. A. Brown and J. E. Lemons, eds., American Society for Testing and Materials, West Conshohocken, PAGoogle Scholar
  76. 76.
    Zhou D, Mech B, Greenberg R (2000) Accelerated corrosion tests on Silicon wafers for implantable medical devices. Proc., of 198th Electrochemical Society Meeting, p363Google Scholar
  77. 77.
    Goken M (1999) Atomic Force Microscopy of Metallic Surfaces. Adv Matls & Processes 155:35–37Google Scholar
  78. 78.
    Lausmaa J, Ask M, Rolander U et al. (1989) Preparation and analysis of Ti and alloyed Ti surfaces used in the evaluation of biological response. Mater. Res. Soc. Symp. Proc. 110:647–653Google Scholar
  79. 79.
    Meeker and Hahn (1985) How to plan an accelerated life test: some practical guidelines, The ASQC basic references in quality control, Vol. 10Google Scholar
  80. 80.
  81. 81.
    Nelson W (1990) Accelerated testing, statistical models, test plans, and data analysis, John Wiley & Sons, New YorkGoogle Scholar
  82. 82.
    Parker SP (editor-in-chief) (1994) McGraw-Hill Dictionary of Scientific and technical Terms, 5th edition, McGraw-HillGoogle Scholar
  83. 83.
    Jacobson DM, Humpston G (2005) Principles of brazing, ASM International, p165.Google Scholar
  84. 84.
    Osberger MJ (1997) Current issues in cochlear implants in children. The hearing review, Vol 4, p 29Google Scholar
  85. 85.
    Severens JL, Brokx JPL and van den Broek (1997) Cost analysis of cochlear implants in deaf children in the Netherlands. Amer J of Otology 18:714Google Scholar
  86. 86.
    Tsukuma K, Kubota Y, Tsukidate T (1984) Advances in ceramics, Vol. 12, Science and technology of zirconia II. Edited by N. Claussen, M. Ruhle, and A. H. Heuer. American Ceramic Society, Columbus, OH, p. 382Google Scholar
  87. 87.
    Sato T, Shimada M (1985) Transformation of Yttria-doped Tetragonal ZrO2 Polycrystals by Annealing in Water. J Am Cer Soc 68 (6): 356–369CrossRefGoogle Scholar
  88. 88.
    Somiya S, Yoshimura M (1987) Zirconia ceramics, Uchida Rokakuho Publishing Co., Ltd, TokyoGoogle Scholar
  89. 89.
    Li JF and Watanabe R (1999) Mechanical properties of PSZ-matrix ceramic composites containing Al2O3 particles with various sizes. Key Eng Matls 161–163:299–302Google Scholar
  90. 90.
    Begand S, Oberbach T, Glien W (2005) ATZ – a new material with a high potential in joint replacement. Key Eng Matls 284–286:983–986CrossRefGoogle Scholar
  91. 91.
    Begand S, Oberbach T, Glien W et al. (2008) Kinetic of the phase transformation of ATZ compared to biograde Y-TZP. Key Eng Matls 361–336:763–766CrossRefGoogle Scholar
  92. 92.
    Ikeda1 J, Pezzotti G, Nakanishi T (2006) Phase stability of zirconia toughened alumina composite for artificial joints. Key Eng Matls 309–311:1243–1246CrossRefGoogle Scholar
  93. 93.
    Begand S, Oberbach T, Glien W (2007) Corrosion behavior of ATZ and ZTA ceramics. Key Eng Matls 330–332:1227–1230CrossRefGoogle Scholar
  94. 94.
    Zhang B, Isobe T, Satani S et al. (1999), The effect of alumina addition on phase transformation and mechanical properties in partial stabilized zirconia. Key Eng Matls 161–163:307–310CrossRefGoogle Scholar
  95. 95.
    Hirano M, Inada H (1991) Hydrothermal stability of yttria- and ceria-doped tetragonal zirconia-alumina composites. J of Matls Sci 26:5047–5052CrossRefGoogle Scholar
  96. 96.
    Zhou D, Chu A, Agazaryan A et al. (2004) Towards an implantable micro pH electrode array for visual prostheses, in Nanoscale Devices, Materials, and Biological Systems: Fundamentals and Applications (Cahay M ed.) pp. 563–576. Electrochemical SocietyGoogle Scholar
  97. 97.
    Huang CQ, Carter PM, Shepherd RK (2001) Stimulus induced pH changes in cochlear implants: An in vitro and in vivo Study. Annals of Biomedical Engineering 29:791–802CrossRefGoogle Scholar
  98. 98.
    Sanders C, Nagler E, Zhou D et al. (2007) Dynamic Interactions of Retinal Prosthesis Electrodes with Neural Tissue and Materials Science in Electrode Design, in Artificial Sight, Basic Research, Biomedical Engineering, and Clinical Advances, Humayun MS et al. (Eds.) Ch 11:209–226, SpringerGoogle Scholar
  99. 99.
    Dursun A, Pugh DV, Corcoran SG (2003) A Steady-State Method for Determining the Dealloying Critical Potential. Electrochemical and Solid-State Letters, 6 (8) B32–B34CrossRefGoogle Scholar
  100. 100.
  101. 101.
    Utter RE (2005) Accelerated life test – your key to new product success., accessed 10 March, 2008
  102. 102.
    Edell DJ (2004) Insulating biomaterials in Neuroprosthetics, Theory and Practice, edited by Horch KW & Dhillon GS, pp. 517–579Google Scholar
  103. 103.
    Pernicka JC (2006) Pernicka unveils world’s first CHLD hermeticity test system for medical and space applications, available online at, Accessed 10 March, 2008
  104. 104.
    Bredendiek-Kämper S, Klewe-Nebenius H, Pfennig G et al. (1989) Surface analytical characterization of the hydrogen getter material ZrCo. Fresenius’ Journal of Analytical Chemistry 335:669–674CrossRefGoogle Scholar
  105. 105.
    Lee SM, Park YJ, Lee HY et al. (2000) Hydrogen absorption properties of a Zr–Al alloy ball-milled with Ni powder, Intermetallics 8:781–784CrossRefGoogle Scholar
  106. 106.
    Liu CZ, Shi LQ, Xu SL et al. (2004) Kinetics of hydrogen uptake for getter materials. Vacuum 75:71–78CrossRefGoogle Scholar
  107. 107.
    Ramesham R, Ghaffarian R (2000) Challenges in interconnection and packaging of micro-electromechanical systems (MEMS) Electronic Components and Technology Conference Proceedings. 50th Volume , Issue 2000:666–675Google Scholar
  108. 108.
    Roy S, Ferrara LA, Fleischman AJ et al. (2001) Micro-electromechanical systems and neurosurgery: a new era in millennium. Neurosurgery 49:779–797CrossRefGoogle Scholar
  109. 109.
    Roy S, Fleischman AJ (2003) Cytotoxicity evaluation for microsystems materials using human cells. Sens and Mat., 15:335–340Google Scholar
  110. 110.
    Roy S, Mehregany M (1999) Introduction to MEMS. In Helbajian H (ed.), Micro-engineering aerospace systems. The aerospace press, El Segundo, CA pp 1–28Google Scholar
  111. 111.
    Ferrara LA, Fleischman AJ, Togawa D et al. (2003) An in vivo biocompatibility assessment of MEMS materials for spinal fusion monitoring. Biomed Microdev 5:297–302CrossRefGoogle Scholar
  112. 112.
    Fleischman AJ (2003) Miniature high frequency focused ultrasonic transducers for minimally invasive imaging procedures. Sens Actu A: Phys 103:76–82CrossRefGoogle Scholar
  113. 113.
    McAllister DV, Allen MG, Prausnitz MR (2000) Micro-fabricated micro-needles for gene and drug delivery. Ann Rev Biomed Eng 2:289–313CrossRefGoogle Scholar
  114. 114.
    Polla DL, Erdman AG, Robbins WP et al. (2000) Microdevices in medicine. Ann Rev Biomed Eng, 2:551–576CrossRefGoogle Scholar
  115. 115.
    Kotzar G, Freas M, Abel P et al. (2002) Evaluation of MEMS materials of construction for implantable medical devices. Biomaterials 23:2737–2750CrossRefGoogle Scholar
  116. 116.
    Roy S, Ferrara LA, Fleischman AJ et al. (2007) MEMS and neurosurgery, In Ferrari M (editor in chief) BioMEMS and biomedical nanotechnology, Vol 3: Therapeutic Micro/nanotechnology (ed. Desai T and Bhatia S) pp 95–123, Springer US.Google Scholar

Copyright information

© Springer Science+Business Media, LLC 2009

Authors and Affiliations

  1. 1.Alfred E. Mann Foundation for Scientific ResearchSanta ClaritaUSA
  2. 2.Second Sight Medical Products, Inc.SylmarUSA

Personalised recommendations