PerDeCT device (Pericardial Device for monitoring Cardiac output and the diagnosis of Tamponade)

在英国，每年有4.5万名患者接受心脏直视手术。大多数手术是冠状动脉搭桥术，其余的包括瓣膜手术、移植手术和先天性心脏病手术。手术时，通过正中切开胸腔，打开包含心脏(心包)的囊。当手术结束时，骨骼(胸骨)、肌肉和皮肤都关闭了。心包处于开放状态，但仍在心脏周围形成一个封闭的囊状结构。术后出血是不可避免的，因此心包内至少留有一根管子(引流管)来引流任何血液。患者可能需要输血，有时还必须回到医院止血。在高达3%的患者中，血液聚集在心包内的心脏周围，并开始凝结，可能会堵塞引流管道。少量不要紧，但如果凝块和血液的收集足够大，它就会开始压缩心脏，使其无法正常工作。这被称为心脏压塞，如果不进行治疗，心脏最终将完全停止泵血，发生心脏骤停。这是非常危险的，因为胸外按压(CPR)是不起作用的，因为心脏已经被完全压缩了。如果及早诊断，患者就会回到医院，重新打开胸腔，清除血块。然而，诊断往往非常困难，因为常规监测的生命体征可能会因其他原因而改变，而且看不到血液在心包内聚集。如果诊断延误，那么将不得不在重症监护病房重新打开胸腔。这远远不是理想的，并导致死亡率和发病率增加高达10倍。本研究项目旨在开发一种简单的、获得专利的球囊装置(PerDeCT)，该装置可在手术时插入心包间隙。一个小探头也被放置在肺动脉周围，以便准确测量心脏的血流量。轻轻地给气囊充气并测量流量，可以更早地检测到心脏压塞。气囊和探头可以与胸腔引流管同时取出，无需重新打开胸腔。我们的团队由资深心胸外科医生领导，汇集了医疗器械设计、测试和监管支持方面的专家。PerDeCT将对患者的安全和遗漏填塞的非常显著的成本产生重大影响。

45,000 patients a year have open heart surgery in the UK. Most surgery is coronary artery bypass, the rest includes valve surgery, transplantation and congenital heart surgery.At surgery the chest is opened through the midline and the sac containing the heart (pericardium) is opened. When the surgery is finished the bone (sternum), muscle and skin are closed. The pericardium is left open but still forms a closed sac around the heart. Some bleeding postoperatively is inevitable and so at least one tube (drain) is left inside the pericardium to drain any blood. Patients may require blood transfusion and occasionally must return to theatre to stop the bleeding.In up to 3% of patients, blood collects around the heart inside the pericardium and starts to clot which may block the drains. Small amounts do not matter but if the collection of clot and blood is large enough it will start to compress the heart and stop it working properly. This is called cardiac tamponade, left untreated the heart will eventually stop pumping completely and a cardiac arrest occurs. This is very dangerous as external chest compression (CPR) doesn't work as the heart is already fully compressed.If the diagnosis is made early, the patient is returned to theatre, the chest re-opened, and the clot removed. However, the diagnosis is often very difficult as the vital signs monitored routinely can change as the result of other causes and the blood cannot be seen collecting in the pericardium. If diagnosis is delayed, then the chest will have to be re-opened in the Intensive Care Unit. This is far from ideal and leads to up to a tenfold increase in mortality and morbidity.This research project is to develop a simple, patented, balloon device (PerDeCT) which is inserted into the pericardial space at surgery. A small probe is also placed around the pulmonary artery to allow accurate measurements of the flow of blood from the heart. Gently inflating the balloon and measuring the flow allows for the much earlier detection of cardiac tamponade. The balloon and probe can be removed at the same time as the chest drains without the need to re-open the chest.Our team is led by a senior cardiothoracic surgeon and brings together experts in medical device design, testing and regulatory support. PerDeCT will have a major impact on patient safety and the very significant costs of missed tamponade.