The long term objective of this research is to commercialize a completely implantable LVAD system that is less expensive, more reliable and more biocompatible than existing percutaneous LVAD systems. Left ventricular assist devices (LVADs) have significantly improved survival in patients bridged to transplant and in destination therapy for end stage heart failure. However, for LVADs to have a significant epidemiological impact on chronic heart failure, device improvements are needed to reduce infection, prevent non-surgical gastrointestinal bleeding, provide automatic speed control, and reduce cost. We propose to continue development of a unique Tesla rotary pump, and to integrate automatic speed control and complete implantability using wireless energy transmission.
The specific aims are: 1. Refine the Phase I design for implantability, integration of pressure sensor, and further size reduction. The pump will be redesigned using thinner sections and a welded construction, with a pressure sensor in the inlet cannula body. Both of these modifications will reduce the pump size. 2. Test the final pump design with integrated pressure-based control through in vitro performance testing and in vivo studies. The redesigned pump will first use an external controller and hardwire for validation and verification of the system software and blood pump performance. After achieving satisfactory in vitro performance and dynamic response, the hardwired pump will be implanted in calves for acute studies. 3. Develop implantable electronics, implantable battery pack, TETS and external components. We will redesign and improve existing selected components such as the TETS primary and secondary coils, the patient external electronics, hermetic connectors, battery packs and enclosures. The same design knowledge applied to previous implanted systems will be applied. 4. Test the fully integrated, wireless system in vitro and in vivo. In vitro testing and limited pre-IDE testing willbe carried out on the integrated system. Complete systems will be evaluated in the bovine model with both acute and chronic studies. Acute studies will be performed to assess the system response to varying physiologic conditions. Chronic 30 day in vivo studies will be conducted to assess the biocompatibility of the system using careful examination of explanted components as well as necropsy and histology findings. 5. Develop design, manufacturing, and test documentation for pre-IDE submission. Throughout the project design documentation and design controls, as described in the FDA Quality System Regulation (QSR) will be utilized to provide a comprehensive design documentation file to the FDA. These techniques are a very effective tool in assuring a successful design and are a requirement of the FDA.
The Tesla pump Left Ventricular Assist System is a completely implantable wireless system intended to be a more reliable, less expensive alternative to current LVAD technologies. Such a device has the potential to greatly expand the use of LVAD therapy in patients requiring long term mechanical circulatory support.
