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用于血管封闭和分割的铁磁热疗:与超声和双极技术的效用及比较研究

Ferromagnetic Heating for Vessel Sealing and Division: Utility and Comparative Study to Ultrasonic and Bipolar Technologies.

作者信息

Chen Jenwood, Manwaring Preston K, Scott Robert R, Manwaring Kim H, Glasgow Robert E

机构信息

University of Utah, Salt Lake City, UT, USA.

Domain Surgical Inc, Salt Lake City, UT, USA.

出版信息

Surg Innov. 2015 Aug;22(4):329-37. doi: 10.1177/1553350615580648. Epub 2015 Apr 14.

Abstract

INTRODUCTION

Vessel sealing technologies have improved surgical efficiency and outcomes. Ferromagnetic technology has potential utility in this area. The aim of this study was to evaluate ferromagnetic heating in sealing and dividing vessels.

METHODS

A novel ferromagnetic (FM) sealer, FMsealer, was developed for sealing and dividing vessels. Using a swine in vivo model, the following endpoints were evaluated: (1) proof of concept, (2) 21-day survival surgery, and (3) comparison with ultrasonic (US) and/or bipolar (BP) devices for subjective outcomes. Seal burst strengths were measured in vitro. Mann-Whitney and Student's t test were used.

RESULTS

After showing proof of concept, 5 swine underwent survival splenectomy, nephrectomy, hysterectomy, and mesenteric vessel division (arteries ranging from 1 to 7 mm in diameter) with necropsy after day 21 showing no evidence of surgical site bleeding. FM was equivalent to BP in tissue retention and superior to BP in spread/tissue desiccation, sticking, and charring (P ≤ .01). The FM was superior to US and BP in speed of 10 cm mesentery division (mean ± SD seconds): FM (12.9 ± 1.0 seconds), US (23.3 ± 4.4 seconds), BP (46.1 ± 5.2 seconds) (P ≤ .01 FM vs US or BP). Seal burst strength and success of sealing a 5-mm carotid artery were as follows (mean ± SD mmHg, % success burst strength >240 mm Hg): FM (710 ± 206 mm Hg, 94% success), US (848 ± 565 mm Hg, 79%), and BP (619 ± 373 mm Hg, 83%).

CONCLUSION

Ferromagnetic heating is an effective and efficient technology for sealing and dividing of vessels. An initial prototype of the FMsealer compared favorably with commercially available products based on ultrasonic and bipolar technologies.

摘要

引言

血管封闭技术提高了手术效率和手术效果。铁磁技术在该领域具有潜在应用价值。本研究旨在评估铁磁加热在血管封闭和离断中的作用。

方法

研发了一种新型铁磁(FM)封闭器,即FMsealer,用于血管封闭和离断。采用猪体内模型,评估以下指标:(1)概念验证;(2)21天存活手术;(3)与超声(US)和/或双极(BP)设备比较主观结果。体外测量封闭破裂强度。采用曼-惠特尼检验和学生t检验。

结果

在完成概念验证后,5头猪接受了脾切除术、肾切除术、子宫切除术和肠系膜血管离断术(动脉直径为1至7毫米),术后21天尸检未发现手术部位出血迹象。FM在组织保留方面与BP相当,在扩散/组织干燥、粘连和炭化方面优于BP(P≤0.01)。在10厘米肠系膜离断速度方面,FM优于US和BP(平均±标准差秒):FM(12.9±1.0秒),US(23.3±4.4秒),BP(46.1±5.2秒)(FM与US或BP比较,P≤0.01)。5毫米颈动脉的封闭破裂强度和封闭成功率如下(平均±标准差毫米汞柱,破裂强度>240毫米汞柱的成功率%):FM(710±206毫米汞柱,成功率94%),US(848±565毫米汞柱,成功率79%),BP(619±373毫米汞柱,成功率83%)。

结论

铁磁加热是一种有效且高效的血管封闭和离断技术。FMsealer的初始原型与基于超声和双极技术的市售产品相比具有优势。

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