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一种带有传感器的手术手套,用于改善产科肛门括约肌损伤的培训和检测:猪模型的临床前研究。

A sensorised surgical glove to improve training and detection of obstetric anal sphincter injury: A preclinical study on a pig model.

机构信息

Wellcome/EPSRC Centre for Interventional and Surgical Sciences, University College London, London, UK.

Elizabeth Garrett Anderson Institute for Women's Health, University College London, London, UK.

出版信息

BJOG. 2024 Jul;131(8):1129-1135. doi: 10.1111/1471-0528.17762. Epub 2024 Jan 22.

Abstract

OBJECTIVE

To create a sensorised surgical glove that can accurately identify obstetric anal sphincter injury to facilitate timely repair, reduce complications and aid training.

DESIGN

Proof-of-concept.

SETTING

Laboratory.

SAMPLE

Pig models.

METHODS

Flexible triboelectric pressure/force sensors were mounted onto the fingertips of a routine surgical glove. The sensors produce a current when rubbed on materials of different characteristics which can be analysed. A per rectum examination was performed on the intact sphincter of pig cadavers, analogous to routine examination for obstetric anal sphincter injuries postpartum. An anal sphincter defect was created by cutting through the vaginal mucosa and into the external anal sphincter using a scalpel. The sphincter was then re-examined. Data and signals were interpreted.

MAIN OUTCOME MEASURES

Sensitivity and specificity of the glove in detecting anal sphincter injury.

RESULTS

In all, 200 examinations were performed. The sensors detected anal sphincter injuries in a pig model with sensitivities between 98% and 100% and a specificity of 100%. The current produced when examining an intact sphincter and sphincter with a defect was significantly different (p < 0.001).

CONCLUSION

In this preliminary study, the sensorised glove accurately detected anal sphincter injury in a pig model. Future plans include its clinical translation, starting with an in-human study on postpartum women, to determine whether it can accurately detect different types of obstetric anal sphincter injury in vivo.

摘要

目的

研发一种可准确识别产科肛门括约肌损伤的感测手术手套,以实现及时修复,减少并发症并辅助培训。

设计

概念验证。

地点

实验室。

样本

猪模型。

方法

在常规手术手套的指尖上安装灵活的摩擦电压力/力传感器。当摩擦具有不同特性的材料时,传感器会产生电流,这些电流可以进行分析。对猪尸体的完整肛门括约肌进行经直肠检查,类似于产后常规检查产科肛门括约肌损伤。使用手术刀穿过阴道黏膜并切入外部肛门括约肌来创建肛门括约肌缺陷。然后再次检查括约肌。解释数据和信号。

主要观察指标

手套检测肛门括约肌损伤的灵敏度和特异性。

结果

共进行了 200 次检查。传感器以 98%至 100%的灵敏度和 100%的特异性检测到猪模型中的肛门括约肌损伤。检查完整括约肌和有缺陷的括约肌时产生的电流明显不同(p < 0.001)。

结论

在这项初步研究中,感测手套在猪模型中准确地检测到肛门括约肌损伤。未来的计划包括将其临床转化,首先在产后妇女中进行人体研究,以确定它是否可以准确地检测体内不同类型的产科肛门括约肌损伤。

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