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.
Implantable Cardioverter-Defibrillators (ICD) and Cardiac Resynchronization Therapy Devices (CRT-D) are exclusively powered by non-rechargeable primary batteries which lead to replacement surgeries that are complex, expensive, and result in increased patient mortality. These batteries may also fail earlier than expected leading to patient death. 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 suffering, and reduce costs.
