Design and Functionality of a Multilumen Thoracic Access Port for Pericardial Access Under Direct Visualization

Area of Science:

• Cardiovascular Medicine
• Biomedical Engineering
• Surgical Innovation

Background:

• Transvenous cardiac lead implantation is often hindered by vascular anomalies, necessitating invasive open-chest procedures.
• Minimally invasive techniques promise reduced patient trauma, pain, and recovery times, while eliminating fluoroscopy use.

Purpose of the Study:

• To introduce PeriPath, a novel, single-use, low-cost pericardial access tool designed for minimally invasive cardiac lead implantation.
• To evaluate the safety, efficacy, and feasibility of the PeriPath device and procedure.

Main Methods:

• The PeriPath device utilizes a modified Seldinger technique for safe pericardial access and lead placement.
• Mechanical design was validated using finite element analysis (FEA) and tensile strength testing.
• Procedure compatibility with existing cardiac lead implantation tools was assessed.

Main Results:

• FEA confirmed the device's structural integrity under clinical conditions.
• Mechanical testing demonstrated sufficient tensile strength and low fracture risk.
• Preliminary animal and physician studies indicated effective function for minimally invasive lead implantation.

Conclusions:

• PeriPath provides a safe and effective solution for minimally invasive cardiac lead implantation, potentially reducing the need for open-chest surgery.
• The device's design, cost-effectiveness, and compatibility suggest widespread adoption by electrophysiologists and interventional cardiologists.