Design of Ceramic Packages for Ultrasonically Coupled Implantable Medical Devices

Objective: Ultrasonic acoustic power transfer is an efficient mechanism for coupling energy to millimeter and sub-millimeter implants in the body. To date, published ultrasonically powered implants have been encapsulated with thin film polymers that are susceptible to well-documented failure modes in vivo, including water penetration and attack by the body. As with all medical implants, packaging with ceramic or metallic materials can reduce water vapor transmission and improve biostability to provide decadal device lifetime. In this paper, we evaluate methods of coupling ultrasonic energy to the interior of ceramic packages. Methods: The classic wave approach and modal expansion are used to obtain analytical expressions for ultrasonic transmission through two different package designs and these approaches are validated experimentally. A candidate package design is demonstrated using alumina packages and titanium lids, designed to be acoustically transparent at ultrasonic frequencies. Results: Bulk modes are shown to be more effective at coupling ultrasonic energy to a piezoelectric receiver than flexural modes. Using bulk modes, packaged motes have an overall link efficiency of roughly 10%, compared to 25% for unpackaged motes. Packaging does not have a significant effect on translational misalignment penalties, but does increase angular misalignment penalties. Passive amplitude-modulated backscatter communication is demonstrated. Conclusion: Thin lids enable the use of ultrasonically coupled devices even with package materials of very different acoustic impedance. Significance: This work provides an analysis and method for designing packages that enable ultrasonic coupling with implantable medical devices, which could facilitate clinical translation.

[1]  G. Maidanik,et al.  Response of Ribbed Panels to Reverberant Acoustic Fields , 1962 .

[2]  J. Fawcett,et al.  A Microchannel Neuroprosthesis for Bladder Control After Spinal Cord Injury in Rat , 2013, Science Translational Medicine.

[3]  Elad Alon,et al.  Wireless Recording in the Peripheral Nervous System with Ultrasonic Neural Dust , 2016, Neuron.

[4]  Yan Li,et al.  [INVITED] Ultrafast laser micro-processing of transparent material , 2016 .

[5]  D. Kipke,et al.  Neural probe design for reduced tissue encapsulation in CNS. , 2007, Biomaterials.

[6]  Thomas Stieglitz,et al.  Manufacturing, assembling and packaging of miniaturized implants for neural prostheses and brain-machine interfaces , 2009, Microtechnologies.

[7]  Brian Litt,et al.  Drug discovery: A jump-start for electroceuticals , 2013, Nature.

[8]  Amir Barati Farimani,et al.  Ultrathin, transferred layers of thermally grown silicon dioxide as biofluid barriers for biointegrated flexible electronic systems , 2016, Proceedings of the National Academy of Sciences.

[9]  Kate Fox,et al.  Hermetic diamond capsules for biomedical implants enabled by gold active braze alloys. , 2015, Biomaterials.

[10]  Elad Alon,et al.  Neural Dust: An Ultrasonic, Low Power Solution for Chronic Brain-Machine Interfaces , 2013, 1307.2196.

[11]  Yeun-Ho Joung,et al.  Development of Implantable Medical Devices: From an Engineering Perspective , 2013, International neurourology journal.

[12]  Jun Chen,et al.  Temperature dependence of piezoelectric properties of high- TC Bi (Mg1/2Ti1/2) O3 - PbTiO3 , 2009 .

[13]  B. Arda Ozilgen,et al.  Ultrasonic thermal dust: A method to monitor deep tissue temperature profiles , 2017, 2017 39th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC).

[14]  Amin Arbabian,et al.  Design of Tunable Ultrasonic Receivers for Efficient Powering of Implantable Medical Devices with Reconfigurable Power Loads. , 2016, IEEE transactions on ultrasonics, ferroelectrics, and frequency control.

[15]  John K. Chapin,et al.  Ceramic-based multisite electrode arrays for chronic single-neuron recording , 2004, IEEE Transactions on Biomedical Engineering.

[16]  Adam Heller,et al.  Integrated medical feedback systems for drug delivery , 2005 .

[17]  R. Traeger,et al.  Nonhermeticity of Polymeric Lid Sealants , 1977 .

[18]  Benjamin C. Johnson,et al.  StimDust: A 6.5mm3, wireless ultrasonic peripheral nerve stimulator with 82% peak chip efficiency , 2018, 2018 IEEE Custom Integrated Circuits Conference (CICC).

[19]  G. Suaning,et al.  Hermetic Encapsulation of an Implantable Vision Prosthesis – Combining Implant Fabrication Philosophies , 2008 .

[20]  Patrick A Tresco,et al.  The brain tissue response to implanted silicon microelectrode arrays is increased when the device is tethered to the skull. , 2007, Journal of biomedical materials research. Part A.

[21]  D W Moran,et al.  A chronic generalized bi-directional brain–machine interface , 2011, Journal of neural engineering.

[22]  E. A. Amerasekera,et al.  Failure Mechanisms in Semiconductor Devices , 1987 .

[23]  Paul P Breen,et al.  BION microstimulators: a case study in the engineering of an electronic implantable medical device. , 2011, Medical engineering & physics.

[24]  Gerald E. Loeb,et al.  Development of BION/spl trade/ technology for functional electrical stimulation: hermetic packaging , 2001, 2001 Conference Proceedings of the 23rd Annual International Conference of the IEEE Engineering in Medicine and Biology Society.

[25]  Benjamin C. Johnson,et al.  17.5 A 0.8mm3 Ultrasonic Implantable Wireless Neural Recording System With Linear AM Backscattering , 2019, 2019 IEEE International Solid- State Circuits Conference - (ISSCC).

[26]  Kaylene C. Stocking,et al.  Intracortical Neural Stimulation With Untethered, Ultrasmall Carbon Fiber Electrodes Mediated by the Photoelectric Effect , 2019, IEEE Transactions on Biomedical Engineering.

[27]  Ming Yin,et al.  A 100-Channel Hermetically Sealed Implantable Device for Chronic Wireless Neurosensing Applications , 2013, IEEE Transactions on Biomedical Circuits and Systems.

[28]  J. Donoghue,et al.  Failure mode analysis of silicon-based intracortical microelectrode arrays in non-human primates , 2013, Journal of neural engineering.

[29]  C.K. Wong,et al.  Silicon-to-silicon wafer bonding with gold as intermediate layer , 2003, Proceedings of the 5th Electronics Packaging Technology Conference (EPTC 2003).

[30]  David R. S. Cumming,et al.  Encapsulation of a liquid-sensing microchip using SU-8 photoresist , 2004 .

[31]  H. G. Davies.  Low frequency random excitation of water-loaded rectangular plates , 1971 .

[32]  Yogesh B Gianchandani,et al.  Micromachined bulk PZT tissue contrast sensor for fine needle aspiration biopsy. , 2007, Lab on a chip.

[33]  Bin Wang,et al.  Radiation efficiency of submerged rectangular plates , 2012 .

[34]  S. Roundy,et al.  Non-dimensional analysis of depth, orientation, and alignment in acoustic power transfer systems , 2018, Smart Materials and Structures.

[35]  A Vanhoestenberghe,et al.  Corrosion of silicon integrated circuits and lifetime predictions in implantable electronic devices , 2013, Journal of neural engineering.

[36]  T. Stieglitz,et al.  Polymers for neural implants , 2011 .

[37]  James D. Meindl,et al.  The Packaging of Implantable Integrated Sensors , 1986, IEEE Transactions on Biomedical Engineering.

[38]  You-Yin Chen,et al.  A Programmable Implantable Microstimulator SoC With Wireless Telemetry: Application in Closed-Loop Endocardial Stimulation for Cardiac Pacemaker , 2011, IEEE Transactions on Biomedical Circuits and Systems.

[39]  Robert J.M. Craik,et al.  Statistical Energy Analysis Of Structure-borne Sound Transmission By Finite Element Methods , 1994 .

[40]  Thomas Stieglitz,et al.  Fabrication and test of a hermetic miniature implant package with 360 electrical feedthroughs , 2010, 2010 Annual International Conference of the IEEE Engineering in Medicine and Biology.

[41]  Amin Arbabian,et al.  A mm-Sized Implantable Medical Device (IMD) With Ultrasonic Power Transfer and a Hybrid Bi-Directional Data Link , 2015, IEEE Journal of Solid-State Circuits.

[42]  Stuart F. Cogan,et al.  Chronic and low charge injection wireless intraneural stimulation in vivo , 2015, 2015 37th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC).

[43]  S. Hayek,et al.  Vibration and acoustic radiation of elastically supported rectangular plates , 1977 .

[44]  Eric M. Yeatman,et al.  Ultrasonic vs. Inductive Power Delivery for Miniature Biomedical Implants , 2010, 2010 International Conference on Body Sensor Networks.

[45]  Gregory W. Auner,et al.  Laser microjoining of dissimilar and biocompatible materials , 2004, SPIE LASE.

[46]  Polina Anikeeva,et al.  Neural Recording and Modulation Technologies. , 2017, Nature reviews. Materials.

[47]  Benjamin C. Johnson,et al.  A wireless and artefact-free 128-channel neuromodulation device for closed-loop stimulation and recording in non-human primates , 2018, Nature Biomedical Engineering.

[48]  F. Fahy.  Vibration of containing structures by sound in the contained fluid , 1969 .

[49]  C. Wallace.  Radiation Resistance of a Rectangular Panel , 1972 .

[50]  Robert J. Bernhard,et al.  Review of numerical solutions for low-frequency structural-acoustic problems , 1994 .

[51]  Victor Krauthamer,et al.  Rapid evaluation of the durability of cortical neural implants using accelerated aging with reactive oxygen species , 2015, Journal of neural engineering.

[52]  Bilong Liu,et al.  Sound transmission of a spherical sound wave through a finite plate , 2017 .