Cannula System for "Bridge to Recovery" Cardiac Assist

描述(由申请人提供)：心力衰竭是当今美国最大的死亡原因。随着长期心脏辅助装置的使用增加，也需要短期的“通向康复的桥梁”应用。该应用程序旨在为心脏能够恢复的患者提供低成本的临时支持。这项“病人筛查”可为一群病人提供保留天然心脏的可能性，并可减少初期使用较昂贵的长期支援服务，从而减轻整体医疗系统的经济负担。 这项拟议研究的最终目标是开发一种新的插管系统，用于“桥接恢复”应用。Abied目前正在使用AB5000和BVS 5000两种脑室辅助系统的常规插管系统。虽然这种插管系统坚固而有效，但它很容易偶尔出血，不能通过微创程序取出。止血和引入微创清扫术都有望显著改善患者的预后，并是患者生活质量的关键问题。以目前的Abied插管为基础，第一阶段的详细研究将开发和测试(在体内)我们的新型插管系统，该系统将消除出血并允许微创取出。第二阶段的研究包括将该系统商业化的开发计划，并将包括更详细的动物研究，以检查原位插管的长期特征。 在我们的部门，对侵入性较小的插管系统的需求非常明显，随着该部门准备满足更多人口的需求，这一需求将变得越来越重要。对于这些患者来说，一个强大的、无并发症的插管系统将在挽救他们的生命方面发挥关键作用。

DESCRIPTION (provided by applicant): Cardiac failure is the, largest single cause of mortality in the United States today. With an increase in the use of long-term cardiac assist devices, there is also a need for the short-term "bridge to recovery" application. This application is intended to provide a low-cost temporary support for patients whose heart is capable of recovering. This "patient screen" can provide a group of patients the possibility of retaining their natural hearts, as well as lower the overall financial burden on the health care system by reducing the initial use of the more expensive long-term support. The ultimate objective of this proposed research is to develop a novel cannula system for "bridge to recovery" application. Abiomed is currently using a conventional cannulation system for this application, with both AB5000 and BVS 5000 ventricular assist systems. Although robust and effective, this cannula system is prone to occasional bleeding and can not be removed by a minimally invasive procedure. Both the elimination of bleeding and introduction of minimal invasive removal are expected to significantly improve the patient outcome and are critical quality of life issues for patients. Starting with the current Abiomed cannulae as a base, detailed studies in phase I will develop and test (in vivo) our novel cannulation system that will eliminate bleeding and allow for a minimally invasive removal. Phase II studies comprise a development program to commercialize the system and will include more detailed animal studies to examine the long-term characteristics of the cannula in situ. The need for a less invasive cannula system is very visible in our sector, and will become increasingly important as the sector poises to address larger populations. For these patients a robust, complication-free cannulation system will play a critical role in saving their lives.