W-Z Biotech LLC

Integration of Compliance Chambers Into Diaphragm Displacement Pump to Double the Pumping Flow of Pediatric Paracorporeal Pulsatile Ventricular Assist Device - the Paracorporeal Berlin Heart Excor Is the Only Fda-approved Ventricular Assist Device (VAD) for Pediatric Patients. This Pulsatile Diaphragm Displacement Pump (DDP) Is Small/light Weight to Facilitate Pediatric Patient Ambulation. However, Excor Efficiency Is Only 50% Since It Withdraws and Pumps Blood at Different Times (interrupted Pulsatile Flow). This Generates a High Peak Blood Flow Rate, Which May Cause Blood Damage. a Paracorporeal Continuous Flow Pedimag Vad Has Also Been Used in Smaller Children. This Centrifugal Pump Is Highly Efficient Due to the Constant Flow Through the Drainage/infusion Cannulas, But the Pedimag Pump Head Must Be Attached to a Bulky/heavy Motor, Which Hinders Ambulation. We Previously Developed a Transapical to Aorta (TAA) Double Lumen Cannula (DLC) for a Minimally Invasive Ambulatory Lvad, Which Showed Excellent 96 HR Performance/hemocompatibility in Neonate Lambs. Our Ultimate Goal Is to Develop an Efficient, Minimally Invasive, Paracorporeal Lvad System for Pediatric Patients, Which Combines the Small Size/weight (ambulation Potential) of Current Interrupted Pulsatile Flow Pump (e.g Excor) and the Current High Efficiency of a Continuous Flow Pump (e.g Pedimag). the Enabling Technology Is a Compliant Diaphragm Displacement Pump (CDDP), Which Has Compliance Chambers Integrated Into the Drainage and Infusion Outlets to Double Blood Flow. the CDDP Will Be High Performing Due to: 1) Noninterrupted/continuous Blood Flow; 2) Infusion/drainage Compliance Chambers That Decrease CDDP Afterload/increase CDDP Preload. the Lower Peak Drainage/infusion Flow of the CDDP Will Also Reduce Blood Trauma. Preliminary Data Showed That Adding Compliance Chambers Increased Pumping Flow From 1.1 to 2.6 L/min and Decreased Peak Flow Rate. the Phase I Sbir Objective Is to Design and Fabricate a CDDP Working Prototype With Optimal Compliance Chambers Size. This CDDP Will Be Tested in Lambs With Our Previously Developed Taa DLC. Specific Aim 1: to Design, Fabricate, and Bench Test a CDDP. Compliance Chambers Will Be Integrated Into the CDDP Drainage and Infusion Outlets. the CDDP Will Be Made of Polycarbonate Housing With a Polyurethane Diaphragm in the Middle. a Tricuspid Valve Will Connect the CDDP Housing to the Two Small Silicone Compliance Chambers. the Final Prototype Will Be Tested for 1 Week in a 37% Glycerin Mock Loop for Performance/reliability/durability. Specific Aim 2: to Test the CDDP Working Prototype in Lambs. the CDDP Will Be Combined With the Taa DLC to Form a Less Invasive, Ambulatory Lvad, Which Will Be Tested in 10-15 KG Lambs (N=9) to Evaluate 6 HR Performance/reliability and Initial Biocompatibility. Prototype Design/fabrication/bench Testing Will Be Done at W-Z Biotech, and the Lamb Studies Will Be Done at the University of Kentucky. Rather Than Fine-tuning Existing Technology, Our CDDP Is a Novel Invention, Which Will Enable a Pulsatile Paracorporeal Vad With Doubled Efficiency. This Technology Can Also Be Used in Adults and May Significantly Impact Cardiogenic Shock/bridge to Heart Transplant Management.