A novel device to improve renal blood flow in cardiorenal syndrome

该项目的目的是协助开发一种新的设备，以治疗心脏肌肉无力（慢性心力衰竭，CHF）等疾病中肾脏血液输送不良。具体来说，我们的目标是建立一个原型，并在CHF的相关动物模型中测试该设备。慢性心力衰竭是一个主要的公共卫生问题，影响10%的60岁以上的成年人口。它与高发病率、死亡率、频繁住院和公共卫生系统的重大费用负担有关。心脏肌肉虚弱导致血液输送到肾脏的能力差。输送到肾脏的激素不足会激活循环中的激素，而循环中的激素又会对心脏产生不利影响，从而进一步损害心脏功能。我们开发了一种新型的基于导管的系统，并获得专利，该系统通过专用设备改善肾功能。概念验证研究表明，该器械应改善CHF患者的肾血流量。考虑到心力衰竭的巨大公共卫生问题和肾脏在这种情况下的重要性，可以通过基于导管的方法定位、永久植入的简单装置的商业潜力很大。该设备目前正在建造的莫纳什大学工程系的专业知识存在方面的生物医学设备和材料工程。然后将在绵羊中进行一系列概念验证研究，因为绵羊的血管系统大致接近人类的尺寸。患有CHF的绵羊将将器械经皮插入主动脉。将在基线（展开前）和展开后测量肾动脉血流、相关循环激素和心脏超声。我们认为上述研究（如果成功）将足以构成明确的概念验证，从而允许器械商业化，最有可能通过与器械公司的许可安排。

The aim of this project is to assist in the development of a novel device to treat poor delivery of blood to the kidneys in conditions such as heart muscle weakness (chronic heart failure, CHF). Specifically we aim to build a prototype and test the device in a relevant animal model of CHF. Chronic heart failure is a major public health problem affecting >10% of the adult population over the age of 60 years. It is associated with high morbidity, mortality, frequent hospitalisation and major cost burden on the public health system. Weak heart muscle results in poor delivery of blood to the kidneys. Poor delivery to the kidneys activates circulating hormones which in turn further impair cardiac function by adverse effects on the heart. We have developed and patented a novel catheter based system for improvement of renal function via a purpose built device. Proof-of-concept studies have shown that the device should improve kidney blood flow in the setting of CHF. Given the huge public health problem of heart failure and the importance of the kidney in this setting, the commercial potential for a simple device that can be positioned via a catheter-based approach, permanently implanted is large. The device is currently being constructed by the Monash University Department of Engineering where expertise exists with regard to biomedical devices and materials engineering. A series of proof-of-concept studies will then be performed in sheep, as the vasculature of the sheep roughly approximates the dimensions of man. Sheep with CHF will have the device inserted percutaneously into the aorta. Measurements will be made of renal artery flow, relevant circulatory hormones and ultrasound of the heart at baseline (pre-deployment) and following deployment. We believe the above studies (should they be successful) will be sufficient to constitute definitive proof-of-concept and thus allow the device to be commercialised, most likely by a licensing arrangement with a device company.