SBIR-STTR Award

One problem facing cardiac surgeons is lack of suitable devices to provide temporary cardiac support to neonates and pediatric aged patients. Existing devices used clinically (ECMO and centrifugal pumps) are too large relative to the size of the patient. The specific aims of this program focus on demonstration of a new rotary pump intended solelv for these special young patients. Our latest creation is a very small, inexpensive centrifugal blood pump for adurt cardiopulmonary bypass procedures. Extensive in vitro testing verifies that this pump is equivalent in flow performance and hemolysis generation to existing centrifugal devices. Preliminary studies show that the Nimbus pump adapts readily to a neonatal/pediatric version. The key innovation is that the resulting pump size (15 cc priming volume) is 1/5 to 1/3 that of existing centrifugal pumps. This study will evaluate this pump concept through in vitro testing of flow performance, hemorysis generation, and shaft seal integrity. In vivo tests, to be performed at the University of Pittsburgh, are intended to demonstrate the hemodynamic performance, biocompatibility and general suitability of this pump for neonatal/pediatric applications. A Phase II study would involve longer in vivo trials and development of the pump and its control as a clinical product.Awardee's statement of the potential commercial applications of the research:The ultimate result of this research has potential commercial application as a product marketed to hospitals in the U.S. and abroad that provide neonatal/pediatric cardiac surgery services.National Heart, Lung, and Blood Institute (NHLBI)

The subject of this work is development of a mechanical circulatory support system (MCSS) intended specifically for use in pediatric care, covering the needs of patients ranging from neonates to small children. A common opinion regarding devices currently approved for this class of patients is that they are disproportionately large, and in general, lack technical innovation associated with MCSSs used in adult care. The underpinnings for the present application are a series of successful in vitro and in vivo experiments conducted during the past 12 months by Nimbus and its development partner the University of Pittsburgh (UOP), which demonstrated the soundness of their pediatric blood pump concept. Now, in Phase II we intend to complete the basic design and validation of the product, and to accomplish a major portion of its device readiness testing in anticipation of clinical trials. Meeting these aims would verify that the pediatric blood pump concept is safe to be evaluated in IDE clinical trial. Such a trial would be the subject Of a Phase III program, wherein we would seek funding to complete the full regulatory requirements governing an IDE device, fabricate fully qualified hardware, determine component reliability levels, and conduct the clinical trial itself. PROPOSED COMMERCIAL APPLICATION: The new Nimbus product has potential commercial application in all hospitals, both in the U.S. and abroad, that perform neonatal-pediatric cardiac surgery.

Thesaurus Terms:
biomedical equipment development, circulatory assist, clinical biomedical equipment extracorporeal circulation, hemodynamics, hemolysis, nonhuman therapy evaluation, pediatrics infant animal, postmortem, sheep