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

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.