Background 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 to deliver pacing leads to the pericardium could reduce tissue damage, minimize pain, shorten recovery time, and obviate the need for fluoroscopy.

Methods A single-use, low-cost pericardial access port was designed based on clinical requirements. The device includes collapsible flange for atraumatic insertion and crossed working channels to provide an optimal view of the surgical field under direct visualization.

Results Finite element analysis and mechanical testing demonstrates that the tensile strength of its components is sufficient for use under clinical working conditions, with minimal risk of fracture. Prior animal work and a physician preliminary validation study suggest that PeriPath functions effectively for minimally invasive lead implantation procedures.

Conclusion The mechanical design of the thoracic access port aids in safe placement of conductive leads to the pericardium. This device may obviate the need for open chest surgery, which may result in decreased incision length, associated pain, risk of infection, and length of hospital stay. The access port is also compatible with common lead implantation tools and may be readily adopted by interventional cardiologists and electrophysiologists, allowing for widespread implementation.