The design, development, and evaluation of a prototypic, prosthetic venous valve

<p>Abstract</p> <p>Background</p> <p>Chronic venous insufficiency is a serious disease for which there is no clearly successful surgical treatment. Availability of a proven prosthetic vein valve could provide such an option by reducing venous reflux while permitting normal antegrade flow.</p> <p>Methods</p> <p>A new prosthetic vein valve design has been developed which mimics the function of a natural valve by ensuring complete closure of the leaflets with minimal obstruction for antegrade flow. A 2:1 mock-up of the device was tested to evaluate its ability to prevent regurgitation and several key modifications were made. A subsequently re-designed 1:1 prototype was then built in 4 slightly different size configurations and then each tested under physiologic conditions of pulsatile flow in both supine and standing positions.</p> <p>Results</p> <p>Each of the configurations showed acceptable amounts of antegrade resistance and effective orifice area and showed low values of regurgitation and % reflux with two of the prototype configurations (flange lengths of 2.5 mm and 3.75 mm) having corresponding values of <2.5 mmHg-min/L, >97%, 11 mL, and 36%, respectively. These values are particularly striking when compared to the corresponding regurgitation and % reflux values of 60 mL and 205%, respectively, when no device is present.</p> <p>Conclusion</p> <p>The results of this study show that this prototype vein valve design is capable of providing significant relief of reflux under realistic conditions without inducing any increase in antegrade flow resistance and warrants further testing with <it>in vivo </it>models.</p

Physiologically-based testing system for the mechanical characterization of prosthetic vein valves

Due to the relatively limited amount of work done to date on developing prosthetic vein (as opposed to cardiac) valves, advances in this topic require progress in three distinct areas: 1) improved device design, 2) relevant device testing conditions, and, 3) appropriate parameters for evaluation of results. It is the purpose of this paper to address two of these issues (#2 and #3) by: 1) performing a study of normal volunteers to quantify the anatomy and hemodynamic features of healthy venous valves, 2) construction of a 2-step, in vitro testing procedure, which simulates both physiologic and postural conditions seen in the lower extremity venous system, and, 3) defining several modified and new parameters which quantify dynamic valve characteristics

Electrostatic endothelial cell transplantation within small-diameter (\u3c6 mm) vascular prostheses: A prototype apparatus and procedure

This article presents a novel, clinically relevant electrostatic endothelial cell transplantation (seeding/sodding) device (U.S. and Foreign Patent Protections Pending) for small-diameter (\u3c6 mm) vascular prostheses. The prototype apparatus was designed and built to tissue engineer 4.0 mm, I.D. GORE-TEX® (W.L. Gore and Associates, Inc.) standard wall graft segments varying in length from 4 to 12 cm. The prototype electrostatic endothelial cell transplantation apparatus is composed of an external and internal conductor, aluminum base, end supports, pillow blocks, filling apparatus, electric motor drive system, and a voltage source. The cylindrical capacitor arrangement of the device along with an electrical potential applied across the internal and external conductors creates the unique feature of this endothelial cell transplantation technique, an electric held within the cylindrical capacitor (within the graft lumen) which in turn induces a temporary positive surface charge on the graft (dielectric material) luminal surface. Multiple studies have shown that a positively charged substrate is more conducive to endothelial cell adhesion and morphological maturation (flattening) (1,2,7,8,10,13-15). This induced positive surface charge dissipates immediately upon removal from the electrostatic endothelial cell transplantation device. Thus, after endothelial cell adhesion the graft luminal surface reverts back to its natural (nonthrombogenic) negative surface charge

Electrostatic endothelial cell seeding technique for small-diameter (\u3c6 mm) vascular prostheses: Feasibility testing

Multiple studies have indicated the importance of surface charge in the adhesion of multiple cardiovascular cell lines including platelets and endothelial cells on the substrate materials (1,4,7-10,12-15). It is the purpose of this article to report a feasibility study conducted using an electrostatic endothelial cell seeding technique. The feasibility study was conducted using human umbilical vein endothelial cells (HUVEC), a static pool apparatus, a voltage source, and a parallel plate capacitor. The HUVEC concentration and seeding times were constant at 560,000 HUVEC/ml and 30 min, respectively. Scanning electron microscopy examination of the endothelial cell adhesion indicated that an induced temporary positive surface charge on e-PTFE graft material enhances the number and the maturation (flattening) of HUVECs adhered. The results indicated that the total number of endothelial cells adhered (70.9 mm2) was increased from 9198 ± 1194 HUVECs on the control (no induced Surface charge) e-PTFE to 22,482 ± 4814 HUVECs (2.4 x control) on the maximum induced positive surface charge. The total number of cells in the flattened phase of adhesion increased from 837 ± 275 to 6785 ± 1012 HUVECs (8.1x) under identical conditions. Thus, the results of the feasibility study support the premise that electrostatic interaction is an important factor in both the endothelial cell adhesion and spreading processes and suggest that the electrostatic seeding technique may lead to an increased patency of small diameter (\u3c6 mm) vascular prostheses