Development of a Novel Angioplasty Catheter for Treatment of Calcified Arteries

冠状动脉疾病非常常见，有显著的相关发病率和死亡率，经常采用球囊血管成形术治疗。冠状动脉钙化在冠状动脉疾病中非常普遍，给血管成形术带来了巨大的挑战。2012年，美国进行了110万例血管成形术；其中38%涉及中到重度钙化。冠状动脉钙化可阻止球囊血管成形术中有效的冠状动脉扩张，导致冠状动脉支架的不完全扩张；是主要不良心血管事件的公认危险因素，包括支架血栓形成和再狭窄。使用较高的球囊压力来破裂钙化会增加并发症和动脉损伤的风险。广泛的冠状动脉钙化常常阻止血管成形术导致冠状动脉旁路移植；这是一种更昂贵的选择。冠状动脉钙化的患病率随着年龄的增长而增加，在老年患者中冠状动脉搭桥术的风险可能高得令人望而却步。我们寻求解决这一未得到满足的需求。我们已经制作了一种新型设备的原型，能够将频率和能量可变的影响传递到钙化部位。这些影响导致血管壁钙化中的微骨折，随后使传统的血管成形术、球囊扩张和支架技术顺利进行。建议的解决方案将使介入心脏病专家能够使钙化冠状动脉的血管成形术更可预测，因此更安全。作为一种标准的无线技术，定位、部署、激活和取回设备几乎不需要额外的培训，只需要最短的程序时间。在血管壁钙内诱导微骨折，将允许在标准球囊扩张和随后的支架置入术期间安全、可预测的低压血管扩张。这种方法还可能将血管成形术的适应症扩展到目前被认为钙化过大而不适合血管成形术的人群，特别是在钙化疾病高发病率但合并疾病排除了心脏直视手术的老年人群。

Coronary artery disease is very common, has significant associated morbidity and mortality, and is frequently treated by balloon angioplasty. Coronary artery calcification is highly prevalent in coronary artery disease and poses a significant challenge to angioplasty procedures. In 2012, 1.1 million angioplasty procedures were performed in the US; 38% of which involved moderate to severe calcification. Coronary artery calcification can prevent effective coronary artery dilation during balloon angioplasty leading to incomplete expansion of coronary stents; a well-established risk factor for major adverse cardiovascular events, including stent thrombosis and restenosis. Use of higher balloon pressures to crack the calcification increases the risk of complications and damage to the artery. Extensive coronary artery calcification frequently precludes angioplasty leading to coronary artery bypass grafting; a costlier alternative. Coronary artery calcification increases in prevalence with age and in older patients in which the risks of coronary artery bypass grafting may be prohibitive. We seek to address this unmet need. We have prototyped a novel device capable of delivering impacts of variable frequency and energy to sites of calcification. Such impacts lead to micro-fractures in vascular mural calcification and subsequently enable traditional angioplasty balloon dilation and stenting techniques to proceed unhindered. The proposed solution would enable the interventional cardiologist to render angioplasty in calcified coronary arteries much more predictable and therefore safe. As a standard over-the-wire technology, little additional training would be needed and minimal procedural time required to site, deploy, activate and retreive the device. Induction of micro-fractures within the vascular mural calcium would then allow safe, predictable low-pressure vessel expansion during standard balloon dilation and subsequent stenting. This approach will also potentially allow extension of the indications for angioplasty procedures into populations where calcification is currently deemed too extensive for angioplasty, particularly in the older population where calcific disease has a high prevalence but co-morbidities preclude open heart surgery.