Epicardial PFA Isolator Clamp

The EPIC Clamp (Epicardial PFA Isolation Clamp) is a next-generation cardiac ablation device designed for minimally invasive surgery (MIS). Unlike traditional clamps that rely on radiofrequency (RF) or cryoablation and require open-heart access, EPIC delivers Pulsed Field Ablation (PFA) in a way that selectively targets cardiac cells while sparing surrounding tissues. The clamp’s swiveling jaw mechanism enables precise and stable pulmonary vein isolation, a critical step in treating Atrial Fibrillation (AFib).

Existing epicardial clamps on the market are not designed for MIS due to their rigid jaws and large profiles, requiring open-heart surgery for proper placement. This poses several challenges: • Limited Access: Conventional clamps cannot fit through small thoracoscopic ports, making MIS procedures impossible. • Inconsistent Contact: Fixed-jaw clamps do not conform to cardiac anatomy, leading to uneven energy delivery and incomplete pulmonary vein isolation. • Tissue Trauma: Without adaptive motion, clamps can cause excessive force on tissue, leading to potential damage and procedural inefficiencies. • Complex Procedures: Surgeons must work around the limitations of existing RF or cryo clamps, increasing operative time and reducing procedural confidence.

I am developing the EPIC Clamp to solve these challenges with a swiveling jaw design that allows the clamp to collapse into a slim “I” shape for easy insertion through an MIS introducer, then expand into a “C” shape for secure tissue engagement. The jaws independently swivel, adjusting to the anatomical curvature of the pulmonary veins, ensuring consistent and complete energy delivery. This design enables precise, controlled PFA energy application, reducing the risk of collateral damage to surrounding tissues while maintaining high procedural efficiency.

The EPIC Clamp is the first and only epicardial PFA clamp designed for MIS procedures, significantly expanding treatment options for AFib. Clinical feedback is already confirming: • Improved Procedural Confidence: Surgeons can perform PFA without concerns of collateral damage, unlike RF and cryo clamps. • Optimized Contact & Energy Delivery: The adaptive jaw motion ensures uniform pulmonary vein isolation, improving treatment effectiveness. • Reduced Trauma & Learning Curve: MIS-compatible design allows for a familiar yet safer approach for surgeons experienced with traditional RF clamps.

• Working as a lead design engineer, came up with the novel jaw swivel mechanism, enabling MIS access while ensuring stable contact for effective PFA energy delivery. • Engineering the mechanical architecture, including CAD (Creo), simulations, calculations, and tolerance stack-ups, while following GD&T, DFA, and DFM principles. • Leading iterative prototyping, refining the design based on surgeon feedback to optimize usability and safety. • Collaborating with cross-functional teams, including clinical, regulatory and manufacturing, to ensure design feasibility and compliance with regulatory framework . • Risk management by complying to ISO 14971, Failure modes and effects analysis (FMEA), Usability analysis • Creating test protocols and collaborating with test labs • Collaborating with manufacturing team for Process optimization and feedback • Contributing to patent filings, protecting the novel design features of the EPIC Clamp.

The design of handle has been inspired from Kerrison bone punches - a common tool used in spine surgeries. I first used a Kerrison as part of a Cadaver lab at Cork, Ireland in 2023.

CAD — Solid Works Simulation — SolidWorks Motion Calculations, Tolerance Stack-up — Microsoft Excel Manufacturing — 3D Printing, Manual Machining Material Selection and DFA Coding — Python (ODE solver), Google Colab

Disclaimer: The information presented in this page is based on published information in form of patents and articles, and does not disclose any commercially sensitive details.