Abstract
Small vasculature, venous obstruction, or congenital anomalies can preclude transvenous access to the heart, often resulting in open chest surgery to implant cardiac therapy leads for pacing, defibrillation, or cardiac resynchronization. A minimally invasive approach under direct visualization could reduce tissue damage, minimize pain, shorten recovery time, and obviate the need for fluoroscopy. Therefore, PeriPath was designed as a single-use, low-cost pericardial access tool based on clinical requirements. Its mechanical design aids in safe placement of conductive leads to the pericardium using a modified Seldinger technique. The crossed working channels provide an optimal view of the surgical field under direct visualization. Finite element analysis (FEA) confirms that the device is likely not to fail under clinical working conditions. Mechanical testing demonstrates that the tensile strength of its components is sufficient for use, with minimal risk of fracture. The PeriPath procedure is also compatible with common lead implantation tools and can be readily adopted by interventional cardiologists and electrophysiologists, allowing for widespread implementation. Prior animal work and a physician preliminary validation study suggest that PeriPath functions effectively for minimally invasive lead implantation procedures.
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