OAK RIDGE NATIONAL ILABORATORY. Development of Thin-Film Battery Powered Transdermal Medical Devices C/O RN L/

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C/O RN L/94-0264, - CRADA Final Report for CRADA Number 0RNIJ94-0264 OAK RIDGE NATIONAL ILABORATORY LOCKHEED MA RTIM/ A Development of Thin-Film Battery Powered Transdermal Medical Devices J. E3.Bates (Principal Investigator) Oak Ridge Niational Laboratory T. Sein Teledyne Electronic Technologies Prepared by the Oak Ridge Ni~tional Laboratory Oak Ridge, Tennessee 37 831 managed by Lockheed Martin E&I:;:y Research Corp. U.S. Department of Energy under contract DE-AC05-960R22464, E! MANAGED AND OPERATED BY LOCKHEED MARTIN ENERGY RESEARCH CORPORATION FOR THE UtWED STATES DEPARTMENT OF ENERGY ORNL-27 (3-96)

DISCLAIMER This report was prepared as an account of work sponsored. byanagency of the United States Government. Neither the United States Government nor any agency thereof, nor any of their employees, make any warranty, express or implied, or assumes any legal liability or responsibility for the accuracy, completeness, or usefulness of any information, apparatus, product, or process disclosed, or represents that its use would not infringe privately owned rights. Reference herein to any specific commercial product, process, or service by trade name, trademark, manufacturer, or otherwise does not necessarily constitute or imply its endorsement, recommendation, or favoring by the United States Government or any agency thereof. The views and opinions of authors expressed herein do not necessarily state or reflect those of the United States Government or any agency thereof..

....... DISCLAIMER Portions of this document may be illegible in electronic image products. Images are pro duced from the best available original document.

C/ORNL/94-0264 CRADA Final Renort for ~ CRADA Number 94-0264 with Teledyne Microelectronics DEVELOPMENT OF THIN-FILM BATTERY PO WERED TRANSDERMAL MEDICAL DEVICES J. B. Bates Oak Ridge National Laboratory......---...... ---- --- - _..

JUL ~6 99 EIS:31fiPl TELEDYNE?.24? 7~6/99 IN REFLY REFER TO: 5153/PMO: 07-099-001., Dr. John Bates Solid!%te Division Oak Ridge National Laboratory P,O, ~C~X2008, MS-6030 Oak Ridge, Tennessee 37831-6030. q(~te~d~ne ELECTRONIC TECHNOLOGIES Medical Devices b.cj!qhr. W&mcmpe~ 1 J964?gna~os~eet k s Alrrdes, CA900(%6534?!ume 3i0.022.8229 F:x 3!G..W.WOS Subject: CRADA No. ORNL 94-0264 Dear John,. Teledyne has reviewed the CRADA number ORNL 94-0264 ( Development of Thin Film!3attery Powered Transdermal Medical Devices with Teledyne- Final Report) and mcertain that it does not contain protected information and can be released. Sincerely yours, TELEDYNE ELECTRONIC TECHNOLOGIES ~.&JJk& Tin Sein Program Manager Medical Devices SBU

CRADA No. ORNL 94-0264 with Teledyne Microelectronics for Development of Thin-Film Battery Powered Transdermal Medical Devices Final Report J. B. Bates Oak Ridge National Laboratory Abstract. Research carried out at ORNL has led to the development of solid state thin-film rechargeable lithium and lithium-ion batteries. These unique devices can be fabricated in a variety of shapes and to any required size, large or small, on virtually any type of substrate. Because they have high energies per unit of volume and mass and because they are rechargeable, thin-film lithium batteries have potentially many applications as small power supplies in consumer and medical electronic products. Initially, the objective of this project was to develop thin-film battery powered transdermal electrodes for recording electrocardiograms and electroencephalograms. These active electrodes would eliminate the effect of interference and improve the reliability in diagnosing heart or brain malfunctions. Work in the second phase of this project was directed at the development of thin-film battery powered implantable defibrillator. Objectives The objectives of this project were the development of transdermal and implantable medical devices that could be powered by the thin-film batteries developed at the Oak Ridge National Laboratory.

Benefits to DOE Missions The work carried out in this project was part of a larger program in the Solid State Division of ORNL aimed at developing new thin-film materiak for lithium and lithium-ion batteries. Therefore, this project suppo&d ORNL S core competencies in Advanced Materials, Synthesis and Processing, Energy Production, and End Use Technology. This project also significantly enhanced the prospects for commercialization of thin-film batteries. Work Performed Phase I Heart and brain activity are monitored by measuring microvolt signals developed on the surface battery side of. the skin. Existing electrocardiogram.:.-=w ed r (EKG) and electroencephalogram (ECG). :~! ~-ifi?.j~:.~f...., cathode,,\ ;.;;*<\\,,.~;;,):.:,~ z recording units measure these small signals using electrodes attached to the skin. The circuit side 1,2 1 long cables attached to the electrodes act as 2.1 an antennas, so the EKG or ECG signals often ~ 4.6an Fig. 1. Layoutof the thin-filmbatteryfabricatedonthe backsideof themultichipmodulepaclcage.connectionof the batteryto thecircuiton thefrontsidewasrnaclewith Au plated through holes which contacted the traces 1and 2 indicated by the arrows. I are corrupted from pickup from fluorescent lights and other sources of spurious AC signals. Through their work for NASA, Teledyne Electronic Technologies has developed specialized equipment for measuring the EKGs and ECGS of astronauts in space. The present CRADA originated from their idea to incorporate a thin-film battery powered preamplifier into the transdermal electrodes for commercial units so that the small EKG and ECG signals could be amplified before transmission to the recording unit. By incorporating thin-film batteries into the circuit to power the amplifiers, no 2

change to existing EKG or ECG recording equipment or increase in the size of the electrodes is required. The work carried out in Phase 1 was directed toward the fabrication of thin-film batteries on the reverse side of cer&nic packages for multichip modules which were prototypes of the transdermal amplifier. A schematic drawing of the front and backside of the device is shown in Fig. 1. At ORNL, research on laboratory-sized thin-film Li-LiMnzOq and Li-LiCo02 batteries was carried out to estabiish their performance characteristics under the conditions that simulated Teledyne s requirements. Details regarding the fabrication of the batteries have been given elsewhere [1,2]. In particular, the investigations included a determination of capacity decrease on cycling using the discharge and charge current densities appropriate to Teledyne s device. The data obtained from these investigations provided the basis for designing prototype batteries having the desired properties. To operate their device, Teledyne requested a battery that could supply 160 pah above 3.4 V for 500 cycles at a discharge current of 20 ua; The battery was to be charged at the short circuit rate. A Li- LiCo02 cell with a 0.6 ~m thick cathode fabricated on the backside of a mukichip module package could supply more than 190 pah at a current of 20 PA and a minimum potential of 3.8 V (Fig. 2). If the cathode 3.7F~/.I 1,,.. 4.1.... 20 PA discharge -. -... ---------100 pa discharge...- -...-----.... ------------......- 3.9... : cathode dimensions: ; 5.6 cm2x 0.6 pm : 35L--W11111111111 1: o 50 100 150 200 Capacity (pah) Fig.2. Charge and discharge curves of a Li-LiCoOz battery fabricated on the backside of a multichip module. thickness should be increased to 2.5 ~m as typical of our present Li-LlCo02 cells, the capacity of a battery with the same active area would be 840 pah. On cycling between 4.2 V and 3 V, the capacity loss was negligible, and so cell retained its capacity of 190 pah after 500 cycles. 3

Phase 2 Two of the important featires of thin-film lithium batteries are their very high energy and power densities. In a joint project with Angieon Corporation and Teledyne, research in the second phase of,,,.......... mls project sought to utihze these properties in the development of an implantable defibrillator powered by a thin-film rechargeable lithium battery. Based on laboratory experiments with 1 cm2 cells, it was apparent that the size of implantable defibrillators could be reduced significantly if the existing primary battery could be replaced with a multicell thin-film battery. In addition, the thin-film battery could be recharged by inductive coupling Fig. 3. Thin-film Li- LiCo02 D cell. through the skin and thus should never need to be replaced. The battery was required to produce on a single charge a minimum of five pulses every two seconds each with a minimum energy of 27 J. For the Li-LiCoOz battery, this translates to 1.5 A pulses of 8.5 s duration having a minimum potential of 2.7 V. Experiments showed that 1 cm2 thin-film lithium batteries with crystalline LiCoOz cathodes could deliver oh a single charge up to 20 pulses of the required duty cycle and potential with an amplitude of 2.5 ma. For a defibrillator, a thin-film battery therefore would need a total active area of about 600 cmz. D -shaped cells (Fig. 3) with - -Im 6.0 5.0 4.0 3.0 2.0 [ 4 1.0-20 0 20 40 60 80 100 120 Time (s) F@.4. Pulse testing of a Li-LiCoOz battery consisting of a parallel connection often, 7.5 cmz D cells. The solid points are the energies at the delivered by each pulse. active areas of 7.5 cm 2 suitable for an implantable defibrillator were fabricated at Teledyne and ORNL. The current collectors, cathode, 4

and electrolyte were deposited at Teledyne, and the lithium anode and protective coating were deposited at ORNL. Tests were conducted on single cells and on batteries consisting of up to ten I cells connected in parallel. A test result for a ten-cell battery with a total active area of 75 cmz is shown in Fig. 4. To meet the device specifications scaled to an active area of 75 cm2, the battery was required to deliver 187.5 rna pulses of the required shape with a minimum energy of 3.4 J per pulse. The results in Fig. 4 show that the battery could deliver twelve of the required pulses before recharge. As expected, these experiments demonstrated that the properties observed for 1 cm2 cells scaled with increasing area. More importantly, the resuits of this study showed that thin film batteries could be used in implantable defibrillator resulting in a significant reduction in device size and an improvement in reliability. Inventions earlier. No inventions originated from this project. The core thin-film battery technology was patented Commercialization Possibilities The work performed in this project demonstrated the applicability of thin-film rechargeable lithium batteries to medical devices. As of this writing, three licenses have been issued, and an additional three are expected to be signed shortly. Pilot production lines are nearing completion at two of the licensees facilities, and it is anticipated that thin film batteries will be commercially available in 2000. The broad commercial interest in ORNL S thin-film battery technology for application in consumer and medical electronics is partly due to the success in this project. Plans for Future Collaboration There are no plans for future collaboration with Teledyne Electronic Technologies.

References 1. J. B. Bates and N. J. Dudney, Thin-FilmR echargeabie Lithium Batteries for ImpIantable Devices; J. ASAIO 43j M644 (1997). 2. J. B. Bates, N. J. Dudney, B. J. Neudecker, and B. Wang, Thin-Film Lithium Batteries: in New Trends in Electrochemical Technology: Energy Storage Systems in Electronics, ed. by T. Osaka and M. Data, Gordon and Breach (in press).

C/ORNL/94-0264 DISTRIBUTION 1. J. B. Bates, Excellatron Corporation, Suite J, 1640 Roswell Street, Smyrn& GA 30080 2. T. Sein, Teledyne Electronic Technologies, 12964 Panama Street, Los Angeles, CA 90066-6534 :: 5, 7-:: 1:: 110 N. J. Dudney, Bldg. 3025, MS 6030 P. L. German, Bldg. 4500N, MS 6269 ~ A. J. Luffman, Office of Science and Technology Partnerships, Bldg. 5002, MS 6416 B. Neudecker, Bldg. 3025, MS 6030 L. S. Thomason, Bldg. 3025, MS 6030 C. A. Valentine, Office of Technology Transfer, 701SCA, MS 8242 Office of Scientific and Technical Information Laboratory Records RC, Bldg, 4500N, MS 6285