SBIR-STTR Award

The proposed research is intended to investigate, test, analyze, and demonstrate the feasibility and potential advantages of a new methodology for continuous flow circulatory support. This methodology combines an innovative blood pumping system with a new, unique control concept for achieving, maintaining and measuring a selected steady blood flow rate. Functional prototypes have been developed, fabricated and tested. The major advantages of this system are expected to include: substantially lower blood damage, longer life, reduced flow sensitivity to downstream pressure, no potential backflow and lower costs compared to centrifugal systems. The specific aims of this proposed research are the blood damage, endurance, functional optimizations and safety testing of this new system in a direct comparison with a current centrifugal system in order to evaluate system safety, efficacy, advantages and disadvantages. The potential advantages of this system are expected to make it acceptable for a large number of clinical uses and commercial applications for circulatory support.Proposed commercial application:The potential commercial applications include all clinical short and medium-term uses of external circulatory support including acute cardiac insufficiency, pediatric ECMO, cardio- pulmonary bypass in surgery, and other current uses of centrifugal pulps.National Institute of Heart, Lung, and Blood Institute (NHLBI)

DESCRIPTION (Adapted from applicant's abstract): The long-term objectives of this research are the development and widespread use of an automated, safer, and more effective pumping system for patient circulatory support. The benefits in health care include: substantially lower blood damage; reduced thrombus accumulation; longer pump life; inherent and accurate blood flow rate control; elimination of backflow; limited, safe blood pressure levels; and lower costs compared to centrifugal blood pumping systems. This system also provided significant control an safety advantages compared to peristaltic pumps. The specific aims of this proposed research are functional optimizations, further improvements in blood compatibility, and development and fabrication of a complete practical system. A technologically innovative pumping control algorithm will be refined and optimized to maximize flow accuracy and speed of response and increase the flow control range for blood pumps covering the entire pediatric and adult ranges of operation. This system will be extensively tested in vitro with bovine blood and subsequently with human blood.PROPOSED COMMERCIAL APPLICATION: Not available.

Thesaurus Terms:
biomedical equipment development, circulatory assist, clinical biomedical equipment, evaluation /testing biomaterial compatibility, biomedical automation, blood circulation, blood flow measurement, computer program /software, extracorporeal circulation, hemolysis animal tissue, human tissueNATIONAL HEART, LUNG, AND BLOOD INSTITUTE