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新型双极电外科血管闭合装置性能更优,操作效率更高。

New Bipolar Electrosurgical Vessel Sealing Device Provides Improved Performance and Procedural Efficiency.

作者信息

Chambers Rheagan, Sarno Danielle, Roweton Susan

机构信息

Surgical Research and Development, Surgical Operating Unit, Medtronic, Lafayette, CO, USA.

出版信息

Med Devices (Auckl). 2025 Jan 25;18:75-86. doi: 10.2147/MDER.S498873. eCollection 2025.

Abstract

PURPOSE

This study compared the performance of the new LigaSure™ XP Maryland Jaw Sealer/Divider (XP Maryland) to that of LigaSure Atlas™ (Atlas) and LigaSure™ Dolphin Tip (Dolphin Tip), two early LigaSure™ (LigaSure) devices characterized by consistent and reliable clinical performance.

METHODS

Ex vivo bench testing on porcine renal arteries compared burst pressures, seal times, and rates of sticking, incomplete cuts, and charring between XP Maryland and Atlas and between XP Maryland and Dolphin Tip. In vivo acute testing on a porcine model compared thermal spread, seal times, and rates of hemostasis, sticking, and incomplete cuts between XP Maryland and the two early LigaSure devices.

RESULTS

Ex vivo, XP Maryland showed a significantly faster mean seal time compared to Dolphin Tip (P < 0.0001) and Atlas (P < 0.0001). XP Maryland had fewer incomplete cuts than Dolphin Tip (P < 0.0001) and fewer sticking incidents than Atlas (P = 0.0019). Atlas had a statistically higher average burst pressure compared to XP Maryland (P < 0.0001). As with ex vivo results, XP Maryland had a significantly faster mean seal time in vivo compared to Dolphin Tip (P = 0.0168) and Atlas (P < 0.0001). Other in vivo results showed XP Maryland had fewer incomplete cuts compared to Dolphin Tip (P < 0.0001) and statistically less lateral thermal spread than Atlas (P = 0.0010). For all other ex vivo and in vivo performance characteristics, no statistically significant differences were found between XP Maryland and the other devices.

CONCLUSION

The study demonstrated the consistent and reliable performance of XP Maryland and the two early LigaSure devices. In addition, the studies showed XP Maryland has some improved performance characteristics when compared to Atlas and Dolphin Tip that may result in improved procedural efficiency and may reduce potential surgical risks.

摘要

目的

本研究将新型LigaSure™ XP马里兰颚部密封器/分离器(XP马里兰)与LigaSure Atlas™(Atlas)和LigaSure™海豚头(海豚头)的性能进行了比较,后两者是两款早期的LigaSure™(LigaSure)设备,具有一致且可靠的临床性能。

方法

在猪肾动脉上进行的体外台架测试比较了XP马里兰与Atlas以及XP马里兰与海豚头之间的破裂压力、密封时间以及粘连、切割不完全和烧焦的发生率。在猪模型上进行的体内急性测试比较了XP马里兰与两款早期LigaSure设备之间的热扩散、密封时间以及止血、粘连和切割不完全的发生率。

结果

在体外,与海豚头(P < 0.0001)和Atlas(P < 0.0001)相比,XP马里兰的平均密封时间明显更快。XP马里兰的切割不完全情况比海豚头少(P < 0.0001),粘连事件比Atlas少(P = 0.0019)。与XP马里兰相比,Atlas的平均破裂压力在统计学上更高(P < 0.0001)。与体外结果一样,在体内,与海豚头(P = 0.0168)和Atlas(P < 0.0001)相比,XP马里兰的平均密封时间明显更快。其他体内结果显示,与海豚头相比,XP马里兰的切割不完全情况更少(P < 0.0001),并且在统计学上比Atlas的侧向热扩散更小(P = 0.0010)。对于所有其他体外和体内性能特征,在XP马里兰与其他设备之间未发现统计学上的显著差异。

结论

该研究证明了XP马里兰和两款早期LigaSure设备性能的一致性和可靠性。此外,研究表明,与Atlas和海豚头相比,XP马里兰具有一些改进的性能特征,这可能会提高手术效率并降低潜在的手术风险。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbdb/11776930/35c5c13f8bbd/MDER-18-75-g0001.jpg

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