LYNNTECH INC. — Department of Health and Human Services SBIR Phase I: R

Description

PROJECT SUMMARY Implantable Cardioverter DefibrillatorsICDand Cardiac Resynchronization Therapy DevicesCRT Dare exclusively powered by non rechargeable lithium primary batteriesand will eventually need to be replaced because of energy depletioneven if all the other components last indefinitelyDevice replacement can result in infection and electrical lead failurewhich are probably the most serious among all possible complications because of their frequencyup todelayed onsetweeks to months post procedureclinical consequencesloss of appropriate or introducing inappropriate device therapylocal abscessesand systemic sepsisrectificationlead extraction and replacementprolonged antimicrobial therapyand excess mortalityup toatyearwhich may linger for up toyears even after apparently successful treatmentDevice replacement immediately incurs the costs of a device unit and a surgical procedurebut the costs of treating the related complications can be many times higherIn additionthe batteries may suffer premature battery depletion due to lithium cluster formation causing shorting of cellsIn Octoberthe FDA initiated a recall ofStJude ICD and CRT D devices due to premature battery depletionThere have beendeaths associated with the loss of defibrillation therapy as a result of premature battery failureAt this timeaffected devices are still in service worldwide andthereforepotentially at riskIn the past decadelithiummanganese dioxideand hybrid lithium silver vanadium oxide carbon mono fluoride chemistries have been developed to prolong the longevity of batteriesModifications to the battery architecturecathode constructionand electrolyte composition have been explored to help protect against lithium cluster formationDespite these effortsthe ICD and CRT D devices still need to be replaced everyyears and premature battery depletion continues to be an issueThe overall objective of this research effort is to develop a long lasting and reliable battery for ICD and CRT D deviceswhich can save livesminimize excessive medical interventionand reduce costsLynntech proposes to develop a next generation all solid stateNASSlithium batteries by using the combination of high conductivity solid electrolyte and advanced nanostructured cathodeThe proposed NASS lithium batteries will not only prolong the longevity of batteries by increasing the cathode energy densitybut also eliminate the issue of premature battery depletion by preventing lithium cluster formationOur specific aims are as followsidemonstrate high capacity of nanostructured cathodeiidemonstrate the capability of solid electrolyte to protect against lithium cluster formationandiiidemonstrate the projected longevity and reliability of NASS lithium batteries exceeding commercial counterpartsIn the Phase II effortLynntechin collaboration with a medical battery manufacturerwill develop and evaluate the prototype packaged batteriesThe final product is expected to be a long lasting and highly reliable all solid state lithium manganese dioxide battery for implantable medical device applications PROJECT NARRATIVE Implantable Cardioverter DefibrillatorsICDand Cardiac Resynchronization Therapy DevicesCRT Dare exclusively powered by non rechargeable primary batteries which lead to replacement surgeries that are complexexpensiveand result in increased patient mortalityThese batteries may also fail earlier than expected leading to patient deathThe overall objective of this research effort is to develop a long lasting and reliable battery for ICD and CRT D deviceswhich can save livesminimize sufferingand reduce costs