Improving Performance and Access to Difficult-to-Reach Anatomy with a Powered Articulating Stapler.

Area of Science:

• Surgical Technology
• Biomedical Engineering
• Surgical Oncology

Background:

• Modern surgical staplers require precise placement and transection, especially in challenging anatomical spaces and with thick tissues.
• The Echelon 3000 Stapler (ECH3) was developed to accommodate tissue and anatomical variations, improving surgical workflow.
• This study evaluated the ECH3 against a comparator stapler for access, seal strength, staple formation, and end effector stability.

Purpose of the Study:

• To evaluate the performance characteristics of the new Echelon 3000 Stapler (ECH3).
• To compare the ECH3's ability to complete a Low Anterior Resection (LAR) transection in one or two firings against a marketed stapler.
• To assess seal strength, staple formation in thick tissue, and end effector stability of the ECH3.

Main Methods:

• Virtual modeling of pelvic anatomy for Low Anterior Resection (LAR) and Monte Carlo simulations to assess stapler firing probability.
• Ex vivo testing using stapled porcine ileum to measure leak pressure and leak rates under critical pressures.
• Assessment of malformed staple rates in thick tissues (3.3- and 4.0-mm) and comparison of end effector stability during firing and under load.
• Surgeon surveys on device functionality and ease of use post-preclinical evaluation.

Main Results:

• The ECH3 demonstrated a significantly higher probability of completing an LAR transection in one or two firings compared to the comparator stapler.
• Stapled porcine ileum with the ECH3 showed a higher median initial leak pressure and a lower rate of leaks at critical pressures (40 and 50 mmHg).
• The ECH3 produced fewer malformed staples in thick tissues and exhibited less end effector angular movement and deflection during firing and under load.
• Surgeons reported precise placement and easy one-handed operation with the ECH3.

Conclusions:

• The Echelon 3000 Stapler offers improved access, tighter seals, reduced malformed staples, and enhanced end effector stability.
• These performance advantages were recognized by surgeons during preclinical evaluations.
• The ECH3 represents a significant advancement in surgical stapler technology for complex procedures.