Crainio non-invasive intracranial pressure monitor for traumatic brain injury: product development

Crainio是一家总部位于伦敦的中小企业，正在开发一种革命性的医疗设备，用于无创测量颅内压（ICP）。目前临床监测颅内压的方法是由神经外科医生通过颅骨上钻的小孔将一个电子传感器直接插入脑组织，并在那里放置约72小时。这对医疗保健提供者来说是有风险的，昂贵的，并且在后勤上非常具有挑战性。Crainio完全克服了这些问题，创造了一种从根本上改变创伤性脑损伤患者的护理和结果的方法，创伤性脑损伤是英国和全世界40岁以下人群中最常见的死亡和残疾原因。这项革命性的技术包括一个小探针，用粘合剂暂时粘在病人的额头上，然后发出无害的近红外光穿过头骨进入大脑。探头通过提取、处理和分析光容积脉搏波信号中的关键信息来测量颅内压，光容积脉搏波信号通过尖端的人工智能返回到前额。这项正在申请专利的技术的概念验证已经在一项关于脑幻影的研究和一项针对ICU中40名严重创伤性脑损伤患者的基础科学研究中得到证实。这项研究在下议院举行的2020年英国STEM活动中获得了金奖，并使Crainio的首席技术官获得了2022年工程师麦西亚奖。这个BMC项目旨在开发Crainio机器学习算法，使其能够以足够的灵敏度和特异性检测颅内压升高，从而使该设备可以用于临床使用。这将通过收集Barts Health NHS Trust ICU中54例外伤性脑损伤患者的光容积描记图数据和并发侵入性探针数据来完成。这项临床研究将由著名的神经外科医生Chris Uff博士领导，将采用Crainio的新型改进探针，用于收集高质量的光容积脉搏波信号。Crainio是从伦敦城市大学（City University of London）分拆出来的。这项研究是由Kyriacou教授的实验室进行的，该实验室以研究和开发非侵入性光学传感器的应用来促进疾病的预后、诊断和治疗而闻名于世。该项目得到了国家健康与护理研究所脑损伤医学技术和体外诊断合作的支持，包括Marek Czosnyka教授和Peter Smielewski博士（MIC的颅内压监测主题负责人），他们都在剑桥大学。

Crainio is a London-based SME developing a revolutionary medical device for non-invasively measuring intracranial pressure (ICP).The current clinical method for monitoring ICP involves a neurosurgeon inserting an electrical sensor directly into the brain tissue through a small hole drilled in the skull and leaving it there for ~72 hours. This is risky, expensive and logistically very challenging for healthcare providers.Crainio completely overcomes these problems, creating a way to radically transform the care and outcomes of people with traumatic brain injury, which is the commonest cause of death and disability in people <40 in the UK and worldwide. The revolutionary technology comprises a small probe that is temporarily stuck to the patient's forehead using adhesive and shines harmless near-infrared light through the skull and into the brain. The probe measures intracranial pressure by extracting, processing and analysing key information from the photoplethysmography signal that returns to the forehead using cutting-edge artificial intelligence.Proof-of-concept of this patent-pending technology has been established in a study on a brain phantom and a basic science study on 40 patients with severe traumatic brain injury in the ICU. This study received the Gold Award Prize at the STEM for Britain 2020 event held at the House of Commons and led to Crainio's Chief Technology Officer winning the Engineers Mercia Award 2022\.This BMC project aims to develop the Crainio machine learning algorithms to the point that they can detect raised intracranial pressure with sufficient sensitivity and specificity that the device can be regulated for clinical use. This will be done by collecting photoplethysmogram data and concurrent invasive probe data from 54 patients with traumatic brain injury in Barts Health NHS Trust ICU. This clinical study, which will be led by distinguished neurosurgeon Dr Chris Uff, will feature Crainio's new, improved probe for the purpose of collecting the high-quality photoplethysmography signals.Crainio is a spin-out from City, University of London. The research was developed by Professor Kyriacou's lab, which is world-renowned for research in understanding and developing applications of non-invasive optical sensors to facilitate prognosis, diagnosis and treatment of disease.The project is supported by the National Institute of Health and Care Research Brain Injury Medtech and In vitro Diagnostics Co-operative, including Professor Marek Czosnyka and Dr Peter Smielewski (the MIC's intracranial pressure monitoring theme leads), who are both based at University of Cambridge.