PROJECT SUMMARY
Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Devices (CRT-D) are
exclusively powered by non-rechargeable lithium primary batteries, and will eventually need to be replaced
because of energy depletion, even if all the other components last indefinitely. Device replacement can result
in infection and electrical lead failure, which are probably the most serious among all possible complications
because of their frequency (up to 7.9%), delayed onset (weeks to months post procedure), clinical
consequences (loss of appropriate or introducing inappropriate device therapy, local abscesses, and systemic
sepsis), rectification (lead extraction and replacement; prolonged antimicrobial therapy), and excess mortality
(up to 25.3% at 1 year, which may linger for up to 3 years even after apparently successful treatment). Device
replacement immediately incurs the costs of a device unit and a surgical procedure, but the costs of treating
the related complications can be many times higher. In addition, the batteries may suffer premature battery
depletion due to lithium cluster formation causing shorting of cells. In October 2016, the FDA initiated a recall
of 398,740 St. Jude ICD and CRT-D devices due to premature battery depletion. There have been 2 deaths
associated with the loss of defibrillation therapy as a result of premature battery failure. At this time 349,852
affected devices are still in service worldwide and, therefore, potentially at risk. In the past decade, lithium-
manganese dioxide, and hybrid lithium-silver vanadium oxide/carbon mono-fluoride chemistries have been
developed to prolong the longevity of batteries. Modifications to the battery architecture, cathode construction,
and electrolyte composition have been explored to help protect against lithium cluster formation. Despite these
efforts, the ICD and CRT-D devices still need to be replaced every 3-7 years and premature battery depletion
continues to be an issue. The overall objective of this research effort is to develop a long-lasting and reliable
battery for ICD and CRT-D devices, which can save lives, minimize excessive medical intervention, and reduce
costs. Lynntech proposes to develop a next-generation all solid-state (NASS) lithium batteries by using the
combination of high conductivity solid electrolyte and advanced nanostructured cathode. The proposed NASS
lithium batteries will not only prolong the longevity of batteries by increasing the cathode energy density, but
also eliminate the issue of premature battery depletion by preventing lithium cluster formation. Our specific
aims are as follows: (i) demonstrate high capacity of nanostructured cathode, (ii) demonstrate the capability of
solid electrolyte to protect against lithium cluster formation, and (iii) demonstrate the projected longevity and
reliability of NASS lithium batteries exceeding commercial counterparts. In the Phase II effort, Lynntech, in
collaboration with a medical battery manufacturer, will develop and evaluate the prototype packaged batteries.
The final product is expected to be a long-lasting and highly reliable all solid-state lithium-manganese dioxide
battery for implantable medical device applications.