Huang Zhifan F, Vandewalle James A, Clymer Jeffrey W, Ricketts Crystal D, Petraiuolo William J
Ethicon, Inc, Cincinnati, OH, USA.
Med Devices (Auckl). 2022 Sep 2;15:329-339. doi: 10.2147/MDER.S379717. eCollection 2022.
Modern surgical staplers should provide precise placement and transection, especially in tight spaces and on thick tissue. Ideally, a stapler would move to accommodate variations in the tissue and anatomy instead of having to move the tissue around to fit the stapler. This study was undertaken to evaluate the performance characteristics of the new Echelon 3000 Stapler (ECH3). Use of the ECH3 was compared to another marketed stapler, including tests for access, seal strength, staple formation in thick tissue, and end effector stability.
Pelvic anatomy measurements were used to construct a virtual model of a Low Anterior Resection (LAR). Monte Carlo simulations were performed on the staplers to compare the probability of completing a transection with one or two firings. Using water infusion of stapled porcine ileum, pressure at first leak and percentage of leaks at critical pressures were measured. Rate of malformed staples was measured in thick tissue. End effector stability while firing and under moderate pressure were compared between staplers. After use, surgeons were surveyed on the functionality of the device.
ECH3 had a markedly higher probability of completing an LAR transection in one or two firings than the comparator stapler. Median initial leak pressure of stapled ileum was significantly higher, and rate of leaks was lower at 40 and 50 mmHg. ECH3 had fewer malformed staples for both 3.3- and 4.0-mm thick tissue. The end effector exhibited less angular movement during firing, and less deflection under a moderate load. Surgeons agreed the ECH3 provided precise placement and easy one-handed operation.
The Echelon 3000 Stapler demonstrated improved access capability, tighter seals, fewer malformed staples, and greater end effector stability. These advantages were recognized by surgeons who evaluated the use of the device preclinically.
现代手术吻合器应能实现精确放置和切断，尤其是在狭小空间和厚实组织上。理想情况下，吻合器应能移动以适应组织和解剖结构的变化，而非让组织移动来适配吻合器。本研究旨在评估新型Echelon 3000吻合器（ECH3）的性能特点。将ECH3的使用情况与另一款市售吻合器进行比较，包括接入测试、密封强度测试、厚实组织中的钉合形成测试以及端部执行器稳定性测试。
利用盆腔解剖测量数据构建低位前切除术（LAR）的虚拟模型。对吻合器进行蒙特卡洛模拟，以比较一次或两次击发完成切断的概率。通过向猪回肠吻合处注水，测量首次渗漏时的压力以及临界压力下的渗漏百分比。测量厚实组织中畸形钉的发生率。比较吻合器在击发时和中等压力下的端部执行器稳定性。使用后，对外科医生进行该设备功能的调查。
与对照吻合器相比，ECH3在一次或两次击发完成LAR切断的概率明显更高。吻合回肠的初始渗漏压力中位数显著更高，在40和50 mmHg时的渗漏率更低。对于3.3毫米和4.0毫米厚的组织，ECH3产生的畸形钉更少。端部执行器在击发时的角向运动更小，在中等负载下的偏转也更小。外科医生一致认为ECH3提供了精确的放置和简便的单手操作。
Echelon 3000吻合器展现出了更好的接入能力、更紧密的密封、更少的畸形钉以及更高的端部执行器稳定性。这些优势得到了在临床前评估该设备使用情况的外科医生的认可。
