Advanced Cannula Development for Coronary Sinus Access

DESCRIPTION provided by applicant This Phase STTR will develop novel techniques for coronary sinus access The coronary sinus provides unique anatomic and physiologic proximity to all four cardiac chambers and the coronary circulation For example the coronary sinus is used for left ventricular lead insertion for biventricular pacing or cardiac resynchronization Mor than such implants are estimated annually in the United States and the procedure is Food and Drug Administration approved treatment for congestive heart failure However transvenous coronary sinus lead insertion fails in of attempts because of angulation valves unstable locations bad thresholds and anomalous anatomy Alternatives include surgical insertion of epicardial leads by thoracotomy or completely deferring this therapy Epicardial lead insertion via thoracotomy is painful with prolonged recovery in heart failure patients and is particularly hazardous when adhesions encase the heart after prior surgery or myocardial infarction Right parasternal mediastinotomy developed for biopsy of intrathoracic tumors is a minimally invasive thoracotomy that has been used for endocardial pacing and could allow unique access to the coronary sinus inside the right atrium However introducers optimized for this purpose are lacking The present STTR would develop three dimensional image configured introducers Specific Aim will use magnetic resonance and X ray computerized tomography imaging in patients to define geometry for coronary sinus cannulation Cost effective techniques for customized patient specific cannula design and manufacturing will be developed Specific Aim will test prototypes to refine designs and methods in six anesthetized pigs Utility of steerable catheters and intracardiac echocardiography will be examined Introducer technology will be derived and prototypes will be available for compassionate use and further development in Phase II Milestones will be assessed at all stages of development Preliminary experience of the research team suggests that this STTR will produce technical advances that will lead to successful commercial development Improved coronary sinus access would facilitate diagnostic and therapeutic interventions including arrhythmia mapping and ablation minimal access cardiac surgery minimally invasive mitral valve surgery mechanical circulatory assistance and reduction of myocardial infarction size Further development of percutaneous access techniques using imaging and tissue sealants could ultimately expand the market for these customized introducers to more than ooo procedures annually

PUBLIC HEALTH RELEVANCE The coronary sinus CS provides unique anatomic and physiologic links to four cardiac chambers and the coronary circulation Many interventions benefit from these close associations but faster and more reliable CS access would facilitate diagnostic and therapeutic advances in as many as procedures annually This STTR employs three dimensional modeling intracardiac echo and advanced technologies to fabricate prototype introducers designed to access the CS from a minimal access right parasternal mediastinotomy