Development of a Novel Angioplasty Catheter for Treatment of Calcified Arteries

冠状动脉疾病非常常见，具有显著相关的发病率和死亡率，并且经常通过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，对血管成形术提出了重大挑战。2012年，美国进行了110万例血管成形术;其中38%涉及中度至重度钙化。冠状动脉钙化可阻止球囊血管成形术期间的有效冠状动脉扩张，导致冠状动脉支架不完全扩张;这是主要不良心血管事件（包括支架血栓形成和再狭窄）的公认风险因素。使用较高的球囊压力来破坏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经常妨碍血管成形术，导致冠状动脉旁路移植术;一个昂贵的替代方案。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，冠状动脉旁路移植术的风险可能是令人望而却步的。我们致力于满足这一未满足的需求。我们已经制作了一种新型设备的原型，能够向钙化部位提供可变频率和能量的冲击。这种冲击导致血管壁钙化中的微破裂，随后使传统的血管成形术球囊扩张和支架植入技术能够不受阻碍地进行。所提出的解决方案将使介入心脏病专家能够使钙化冠状动脉中的血管成形术更可预测，因此更安全。作为一种标准的整体交换技术，定位、展开、激活和回收器械所需的额外培训很少，手术时间也很短。然后，在血管壁钙内诱导微断裂将允许在标准球囊扩张和随后的支架植入期间安全、可预测的低压血管扩张。这种方法还可能允许将血管成形术的适应症扩展到目前认为钙化过于广泛而无法进行血管成形术的人群中，特别是在钙化疾病患病率高但合并症排除心脏直视手术的老年人群中。

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.