SBIR Phase I: Subcutaneous vascular access device that allows hydraulically controlled on demand access to blood flow for hemodialysis

这个小型企业创新研究(SBIR)第一阶段项目的更广泛影响/商业潜力是改善美国每年接受每周三次血液透析治疗的500,000多名终末期肾病患者的生活。血液透析需要将患者的血液取出并通过过滤器进行清洗，然后再将其返还给患者。由于传统的血液通路不能有效维持，患者往往得不到足够的透析治疗。这导致感染、住院率和死亡率增加。除了给患者带来不必要的痛苦外，维护这些血液通道的成本每年超过20亿美元。这种植入式装置将提高我们对血液透析缺点的技术和科学认识，并可能促进与动脉和静脉通路相关的医学领域的知识。这项创新将通过维持血液通路和降低感染率，为这一脆弱的患者群体提供增强的血液透析治疗。拟议的项目是创建一种血管通路设备，确保终末期肾病(ESRD)患者在不需要动脉化静脉系统的情况下拥有可靠的血管通路。房室瘘和房室移植物往往不成熟，长期通畅率较低，导致患者失去了透析的生命线--S。目的是创造一种完全皮下装置，它可以与动脉和单独的静脉吻合，使得动脉装置可以获得至少400ml/分钟的血流量，静脉装置可以至少400ml/分钟的速度返回透析后的血液。该装置必须仅在需要时才允许血液流过其管腔，并在每次使用后将天然血管系统恢复到其正常流动状态。技术困难在于如何配置该装置的机械结构及其与血管的吻合，以允许其按需打开和关闭，而不会导致在天然血管或装置内形成血栓。我们将使用计算流体动力学建模和迭代设计过程来实现我们的原型。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to improve the lives of over 500,000 patients with end stage renal disease receiving thrice-weekly hemodialysis treatments in the US each year. Hemodialysis requires the blood of a patient to be removed and passed through a filter for cleaning prior to returning it to the patient. Oftentimes patients receive insufficient dialysis treatments because the traditional blood pathways cannot be effectively sustained. This leads to increased infections, hospitalization rates and deaths. In addition to the unnecessary suffering of patients, the cost of maintaining these blood pathways is over $2B annually. This implantable device will improve our technical and scientific understanding of hemodialysis shortcomings and may lead to advancing the knowledge in medical fields related to arterial and venous access. This innovation will allow enhanced hemodialysis treatments for this vulnerable patient population by maintaining blood pathways and lowering infection rates.The proposed project is to create a vascular access device which ensures that end stage renal disease (ESRD) patients have reliable vascular access without the need for an arterialized venous system. AV fistulas and AV grafts often fail to mature and are associated with suboptimal long-term patency rates resulting in a loss of the patient?s life line to dialysis. The objective would be to create a completely subcutaneous device which can be anastomosed to an artery and a separate vein such that the arterial device can obtain a blood flow of at least 400ml/min and the venous device can return the dialyzed blood at a rate of at least 400 ml/min. The device must allow blood flow through its lumen only when needed and return the native vasculature to its normal flow state after each use. The technical difficulty is how to configure the mechanics of the device and its anastomosis to blood vessels in a manner which allows it to be opened and closed on demand without causing thromboses to form within the native vessels or device. We will be using computational fluid dynamic modeling and an iterative design process to achieve our prototype.