The 2003 Annual Meeting of OASYS_NEW

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Dissolvable Intravascular Stents for Venous Microvascular Anastomosis

Drake DB1, Birchenough SA2, and Amiss LR1. (1) Plastic and Reconstructive Surgery, University of Virginia Health System, P.O. Box 800376, Charlottesville, VA, USA, (2) Plastic and Reconstructive Surgery (Medical Student), University of Virginia Health System, P.O. Box 800376, Charlottesville, VA, USA

Research into developing a dissolvable, intravascular stent for venous anastomoses with preliminary in-vivo results is discussed. The objective is to create a stent which will help facilitate suture anastomoses of venous microvessels. Intravascular venous stents are particularly useful in maintaining patency, proximity and orientation of the vessel ends as well as reducing the time to complete the anastomosis. These characteristics help avoid back-wall stitching, aid in avoiding torsion at the anastomosis site, and decrease overall clamp time. Three materials were assessed for feasibility as intravascular venous stents: polyethylene glycol (PEG), glycerol with stearic acid, and polyvinyl alcohol (PVA). Combinations of these materials were also assessed (PEG + glycerol and PVA + glycerol). Characteristics of the stents assessed include strength, structure, ease of formation, solubility in water and in-vivo, and ease of handling. In-vivo tests using a rat femoral vein model were performed to further assess the stents. Solubility of the stent is an important parameter and requires tight control. The stent must help maintain vessel patency long enough to complete a suture anastomosis over 10-15 minutes. However, the stent must be sufficiently dissolved by the end of the anastomosis to avoid thrombogenesis, particularly in the venous low-flow vessels. Properties of the stents which affect solubility include shape, molecular weight, amount and type of plasticizing agent, and solvent temperature. The hydrolysis percentage is an additional property which affects PVA solubility. Preliminary results from in-vitro and in-vivo tests indicate that PVA has the desired characteristics of strength and ease of formation. Five PVA formulations (varying hydrolysis percentages) were tested, allowing solubility to be optimized to match our requirements. Initial formulations of PEG (as described in previous research) and glycerol with stearic acid were highly soluble. These proved difficult to handle and ineffective at maintaining vessel patency long enough to complete the anastomosis. On-going work includes further in-vivo tests of suture anastomoses with and without the stents comparing anastomosis time, thrombogenicity, and ease of use.