微创珠状电外科分离器、基础科学和试点研究。

Aesthetic surgery journal. Open forum Pub Date : 2024-05-06 eCollection Date: 2024-01-01 DOI:10.1093/asjof/ojae034
Taiyo C Weber, Mark Jewell, Carl I Schulman, Jefferson Morgan, Alison M Lee, Alicia K Olivier, Elizabeth A Swanson
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引用次数: 0

摘要

背景:微创珠状电外科解剖器("BEED装置")可同时进行锐性解剖、钝性解剖和电外科凝固,在0.8至3分钟内完成100平方厘米猪组织平面解剖,出血量极少,无穿孔:该研究旨在报告基础科学和潜在的临床应用,并通过视频记录体内和体外猪模型平面解剖的速度和质量,同时通过热损伤和组织病理学测量进行量化。此外,还对体内猪标本进行了为期 90 天的跟踪观察,以通过摄影、录像、体格检查和双超声波检查来显示是否在大体或宏观基础上发生了不良事件:使用 BEED 剖析器(已获得美国食品与药物管理局 510(k) 许可 (K233002))对猪体外模型进行 20、30 和 50 W 的单冲程穿刺,并使用多通道热电偶、3 秒延迟记录和匹配的苏木精和伊红 (H&E) 组织病理学检查。在安乐死前,对 H&E、胶原蛋白和弹性蛋白进行组织病理学检查,并进行标准和多普勒超声检查:在体外模型中,5 至 8 毫米宽的剥离器以 1 至 2 厘米/秒的速度通过(在体内模型中为 1 至 10 厘米/秒),在 50 瓦功率下平均温升为 5°C。根据超声波和组织病理学的记录,未穿衣服、无保护的伤口出现了临床上明显的血清肿,并在 90 天前消退:体内和体外模型显示的热值低于已知会损伤皮下脂肪组织或皮肤的水平。组织病理学证实了愈合参数,多普勒超声显示治疗后组织血流正常:
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Minimally Invasive Beaded Electrosurgical Dissectors, Basic Science, and Pilot Studies.

Background: Minimally invasive beaded electrosurgical dissectors ("BEED devices") provide simultaneous sharp dissection, blunt dissection, and electrosurgical coagulation while performing 100 cm2 porcine tissue plane dissections in 0.8 to 3 min with minimal bleeding and no perforations.

Objectives: The aim of the study was to report the basic science and potential clinical applications and to video document the speed and quality of planar dissections in in vivo and ex vivo porcine models with thermal damage quantified by thermal and histopathologic measurements. Additionally, in vivo porcine specimens were followed for 90 days to show whether adverse events occurred on a gross or macroscopic basis, as evidenced by photography, videography, physical examination, and dual ultrasonography.

Methods: Ex vivo porcine models were subjected to 20, 30, and 50 W in single-stroke passages with BEED dissectors (granted FDA 510(k) clearance (K233002)) with multichannel thermocouple, 3 s delay recordation combined with matching hematoxylin and eosin (H&E) histopathology. In vivo porcine models were subjected to eight 10 × 10 cm dissections in each of 2 subjects at 20, 30, and 50 W and evaluated periodically until 90 days, wherein histopathology for H&E, collagen, and elastin was taken plus standard and Doppler ultrasounds prior to euthanasia.

Results: Five to 8 mm width dissectors were passed at 1 to 2 cm/s in ex vivo models (1-10 cm/s in vivo models) with an average temperature rise of 5°C at 50 W. Clinically evidenced seromas occurred in the undressed, unprotected wounds, and resolved well prior to 90 days, as documented by ultrasounds and histopathology.

Conclusions: In vivo and ex vivo models demonstrated thermal values that were below levels known to damage subcutaneous adipose tissue or skin. Tissue histopathology confirmed healing parameters while Doppler ultrasound demonstrated normal blood flow in posttreatment tissues.

Level of evidence 4:

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