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表皮下水分扫描仪:技术解析

The subepidermal moisture scanner: the technology explained.

作者信息

Gefen Amit, Ross Graham

机构信息

Professor of Biomedical Engineering, The Herbert J. Berman Chair in Vascular Bioengineering; Department of Biomedical Engineering, Faculty of Engineering, Tel Aviv University, Tel Aviv 6997801 Israel.

Vice President of Research and Development and Intellectual Property, Bruin Biometrics Inc., 10877 Wilshire Blvd., Suite 1600, Los Angeles, CA 90024 US.

出版信息

J Wound Care. 2020 Feb 1;29(Sup2c):S10-S16. doi: 10.12968/jowc.2020.29.Sup2c.S10.

Abstract

The objective of this article is to explain the biophysical principles underlying the design of the subepidermal moisture (SEM) scanner, commercially known as the 'SEM scanner'. We also describe the mode of operation of the SEM scanner in monitoring tissue health and detecting subtle abnormal changes in tissue physiology in patients and anatomical sites at a risk of a pressure ulcer (PU: also known as a pressure injury). The technology of the SEM scanner was approved last year for sales in the US by the Food and Drug Administration (FDA). The SEM scanner detects changes in fluid contents of human skin and subdermal tissues, to a tissue depth of several millimetres, by measuring 'capacitance', an electrical property of the locally examined tissue site to store electric charge. The capacitance of tissues, called 'biocapacitance', is strongly affected by the amount of fluid (water) in the tissue. When the first cells die in a forming PU, inflammatory signalling causes the permeability of blood vessel walls to increase and oedema to develop. Simply, the scanner detects the early appearance of oedema, which is called 'micro-oedema.' Calculation of a 'SEM-delta' value, which compares biocapacitance measurements, acquired across several tissue sites, some of which are healthy and others where the PU may evolve, eliminates potential effects of systemic changes in tissue fluid contents and provides a consistent quantitative measure of the tissue health conditions at the monitored anatomical site. Here, we describe SEM scanner technology, how it operates and has been laboratory tested (in computer simulations, ) before commercial launch. We explain why targeting the physical biomarker of oedema leads to the documented success of the SEM scanner in the multiple published clinical trials, proving its ability to early detect PUs that form under intact skin.

摘要

本文的目的是解释皮下水分(SEM)扫描仪(商业上称为“SEM扫描仪”)设计背后的生物物理原理。我们还描述了SEM扫描仪在监测组织健康以及检测有发生压疮(PU:也称为压力性损伤)风险的患者和解剖部位的组织生理细微异常变化时的操作模式。SEM扫描仪技术去年获得美国食品药品监督管理局(FDA)批准在美国销售。SEM扫描仪通过测量“电容”来检测人体皮肤和皮下组织中液体含量的变化,检测深度可达几毫米,电容是局部检查的组织部位存储电荷的一种电学特性。组织的电容,即“生物电容”,受组织中液体(水)含量的强烈影响。当形成压疮时最初的细胞死亡,炎症信号会导致血管壁通透性增加并出现水肿。简单来说,该扫描仪检测到水肿的早期出现,即“微水肿”。通过计算“SEM差值”值,比较在多个组织部位采集的生物电容测量值,其中一些部位是健康的,另一些部位可能会发展为压疮,这样可以消除组织液含量系统性变化的潜在影响,并为监测的解剖部位的组织健康状况提供一致的定量测量。在此,我们描述SEM扫描仪技术、其工作方式以及在商业推出之前如何在实验室进行测试(在计算机模拟中)。我们解释了为何针对水肿的物理生物标志物能使SEM扫描仪在多项已发表的临床试验中取得成功,证明其能够早期检测出在完整皮肤下形成的压疮。

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