Ex vivo sealing performance of a sutureless dual-component connector for coronary bypass

Abstract

Sutureless coronary connectors may enable minimally invasive bypass surgery, but consistent sealing in human vessels remains a key challenge. This ex vivo study evaluates the hydrostatic performance of a titanium connector that employs a novel sealing principle: tissue-to-metal coaptation enabling stepwise distal anastomosis construction. Thirteen anastomoses were created in porcine and human cadaveric vessels using a standardized three-step deployment protocol. Target sites included internal mammary arteries, saphenous veins, and coronary arteries, selected for suitability for hand-suturing. Sealing was assessed by hydrostatic pressure testing up to 300 mmHg. Key anatomical parameters and procedural outcomes were recorded. Twelve of 13 anastomoses were completed without leakage up to 300 mmHg; one case exhibited minor oozing at 260 mmHg. The connector accommodated vessels down to 1.3 mm in diameter and up to 0.8 mm wall thickness. One misdeployment due to an oversized incision was corrected intraoperatively without compromising the hydrostatic result. Visual inspection confirmed wide, unobstructed anastomotic orifices. This ex vivo evaluation demonstrates that the connector achieved consistent hydrostatic sealing through bare-metal vessel coaptation, even in small-diameter human coronary tissue. These findings support further in vivo validation towards minimally invasive coronary bypass applications.