SBIR Phase I: Development and Characterization of Bio-inert UNCD films for Implantable Devices to Eliminate Blood Clotting

这个小型企业创新研究第一阶段项目将研究UNCD®，一种由光滑、薄的钻石制成的纳米晶，作为植入式医疗设备的抗血栓涂层。植入式循环辅助装置(如人工心脏和血管辅助装置(VAD))的最大问题之一是需要使用抗凝剂治疗患者，以避免装置内的血栓，并避免在抗凝剂量不当时可能发生的心脏病发作、中风和死亡。以前关于钻石和类钻石碳(DLC)的研究表明，涂层和人体凝血因子之间的相互作用减少。然而，UNCD的使用具有整体的生物化学和电化学惰性、极高的耐磨性和非常低的表面粗糙度，将扩大以前使用其他碳材料所展示的优势。这项研究的更广泛影响是，可能会减少或消除植入医疗设备的患者的抗凝剂，使更多的患者有资格使用先进的设备，如心脏泵，并使这些设备能够用于新的应用。这些设备和类似设备的血液接触表面上的UNCD涂层有可能消除抗凝需要，或将其减少到极低的剂量，从而消除致命出血的风险。仅处方药成本的降低就可以支付这笔投资的数倍以上。基础工作还将阐明动态血流、表面化学和形态变化对血栓/凝块形成的影响。该奖项由2009年美国复苏和再投资法案(公共法律111-5)资助。

This Small Business Innovation Research Phase I project will investigate UNCD®, a nanocrystalline from of smooth, thin diamond, as an anti-thrombotic coating for implantable medical devices. One of the largest problem with implantable circulatory assist devices such as artificial hearts and vascular assist devices (VADs) is the need to treat patients with anticoagulants to avoid blood clots within the devices and to avoid heart attack, stroke, and death that may occur if the anticoagulation dosage is not right. Previous work on diamond and diamond-like carbon (DLC) has demonstrated reduced interactivity between the coating and human blood clotting factors. The use of UNCD however, with its overall biochemical and electrochemical inertness, extreme durability to wear, and very low surface roughness, will extend the advantages previously demonstrated with other carbon materials. The broader impacts of this research are the potential reduction or elimination of anticoagulants for patients with implanted medical devices, making a much larger patient population eligible for advanced devices such as heart pumps, and enabling the use of these devices for new applications. UNCD coatings on the blood contacting surfaces of these and similar devices has the potential to eliminate the need for anticoagulation or to reduce it to so low a dose that the risk of fatal bleeding can be eliminated. The reduction in prescription costs alone could pay for this investment many times over. Fundamental work will also shed light on the effects of dynamic blood flow, variations in surface chemistry and morphology on the thrombus/clot formation.This award is funded under the American Recovery and Reinvestment Act of 2009 (Public Law 111-5).