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BIOENGINEERING FLUID FLOW ANALYSIS SOFTWARE

$99,977R43FY2000HLNIH

Applied Research Associates, Inc., Albuquerque NM

Investigators

Abstract

Development of a software product is proposed to improve the design process and product quality of biomedical devices by combining an innovative blood damage model with computational fluid dynamics (CFD) methods. The resultant product will be able to predict the flow performance of blood handling devices such as the pumps used in open- heart surgery as well as predict such important characteristics as blood hemolysis. The aim of Phase 1 is to demonstrate the feasibility of the software design tool. This will be accomplished in a three step program to: (1) develop a prototype type blood flow damage model that predicts hemolysis rate; (2) incorporate the blood damage model into a fluid flow analysis.; and (3) demonstrate the utility of the model by comparing the predicted hemolysis rate for a heart pump with data obtained by experiment. The proposed product will provide an improved design method for medical devices that is faster, cheaper, and more reliable. This product will be able to provide a quantitative measure of blood damage occurring in prototype blood handling devices and will lead to higher quality medical devices that are less damaging to the blood. PROPOSED COMMERCIAL APPLICATIONS: Objective: To develop bioactive, mechanically responsive scaffolds for bladder repair. Significance: Augmentation of bladder is an effective treatment modality for voiding disorders arising from a variety of etiologies. Materials are needed that would facilitate bladder reconstruction. Hypothesis: Grafting a collagen-derived cell binding peptide on a resorbable polymer scaffold will facilitate the adhesion, migration, and differentiation of cells. Background and Previous Work: Biomaterials are made to be inert towards cells in order to forestall adverse reaction yet many biologically inactive materials elicit local fibrosis and other sequelae of inflammatory response. Previous work based on our discovery of a potent non-RGD cell binding domain in type I collagen showed that the incorporation of its synthetic peptide analogue P-15 in a variety of substrates promotes cell adhesion, migration, and differentiation both in vitro and in vivo. Specific Aims: (I) To synthesize resorbable polyester matrices containing P-15, (2) Examine the adhesion, migration, and colonization of matrices by urothelium, smooth muscle cells, and fibroblasts, (3) Examine the expression of matrix macromolecules (4) Examine the effect of growth factors TGF-beta, EGF, PDGF, KGF on colony formation and matrix macromolecule expression. In Phase II, the performance of these matrices will be evaluated in vivo in experimental animal models in preparation for testing in humans. PROPOSED COMMERCIAL APPLICATIONS: Currently, bladder repair is carried out with autologous or allograft tissues derived from organs such as the gut wall. These studies will lead to the development of effective synthetic bioactive matrices for bladder repair. There is a major market opportunity for such products.

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