Miniaturized Distal Vibration System for Penetration of Vascular Occlusions

描述（由申请人提供）：慢性全闭塞（CTOs），定义为血管完全闭塞3个月，是一种常见的血管疾病，约三分之一的冠状动脉造影患者和30-50%的外周手术患者均有发现。cto的血运重建术为患者提供了重要的益处，包括减少心绞痛症状，改善左心室功能，减少冠状动脉旁路移植术（CABG）的需要，降低死亡或心肌梗死（MI）的发生率，但成功率仍然相当低。到目前为止，无法使用导针穿过CTO是导致CTO血运重建失败的主要原因（在一些研究中占89%），因此医疗设备制造商专注于通过两种策略提高交叉率：专门的CTO导线和专用的CTO设备。然而，这些新设备要么增加了血管穿孔和夹层的风险，要么在CTO穿透方面收效甚微。因此，对于主动CTO设备的需求仍然没有得到满足，这种设备需要安全、高效地穿过CTO隧道，并增加传统导丝（干预列表的主要设备）的使用。Frantz Medical Development （FMD）已经确定了一种解决方案来满足这一未满足的需求：将微型电磁发动机集成到血管导丝和导管组合的远端。发动机的结构是将一系列间隔磁珠固定在导丝上，并为导管配备相应的线圈段。用交流电驱动线圈产生交变磁场，磁场作用于磁体使导丝振动。导丝尖端的振动为主动穿透cto提供了额外的穿透力。用户可以在任何需要额外穿透力的时候激活振动，然后关闭系统，恢复到无源导丝，保持与传统导丝相同的感觉和处理特性。基于令人鼓舞的可行性结果，FMD准备了这个提案，描述了第一阶段，概念发展的目标和策略。在第一阶段完成后，FMD将建立第三代VTG系统原型，并将其用于验证穿越难熔cto技术的安全性、有效性和可用性。第三代设计将按比例缩小到最终尺寸，并将纳入各种其他性能改进。然后，最终的规模原型将用于微调操作参数，并确认该设备的安全性、有效性和可用性，无论是在实验台上还是在体内动物研究中。此外，口蹄疫将为下一阶段的开发和商业化建立一条明确的道路。

DESCRIPTION (provided by applicant): Chronic total occlusions (CTOs), defined as vessels that have been completely occluded for 3 months, are a prevalent vascular disease found in about one-third of patients undergoing a coronary angiogram and in 30-50% of peripheral procedures. Revascularization of CTOs offers important benefits to the patient including reduced angina symptoms, improved left ventricular function, reduced need for Coronary Artery Bypass Graft (CABG), and a lower incidence of death or Myocardial Infarction (MI), but success rates are still considerably low. Inability to cross a CTO with a guide wire is by far the leading cause of failed CTO revascularization attempts (89% of cases in some studies), thus medical device makers have focused on improving cross rates via two strategies: specialized CTO wires and dedicated CTO devices. However, these new devices have either resulted in increased risk of perforation and dissection of the vessel or have had marginal improvements in CTO penetration. Therefore, there is still an unmet need for an active CTO device that is safe, highly effective at tunneling through CTOs, and augments the use of a conventional guide wire - the workhorse device of intervention lists. Frantz Medical Development (FMD) has identified a solution to this unmet need: a miniaturized electromagnetic engine incorporated into the distal end of a vascular guide wire and catheter combination. The engine is constructed by fixing a series of spaced magnetic beads to a guide wire and outfitting the catheter with a corresponding set of coil segments. Driving the coils with alternating current produces an alternating magnetic field, which acts on the magnets to vibrate the guide wire. The vibrations at the guide wire tip provide additional penetrating force for active penetration through CTOs. Users can activate the vibrations anytime additional penetrating power is desired, and then switch off the system to return to a passive guide wire that retains the same feel and handling characteristics of a traditional wire. Based on encouraging feasibility results, FMD has prepared this proposal describing the goals and strategy of Phase I, Concept Development. By the completion of Phase I, FMD will have built 3rd Generation prototypes of the VTG System and used them for validating the safety, efficacy, and usability of the technology for crossing refractory CTOs. The 3rd Generation design will be scaled down to final size and will incorporate various other performance improvements. The final scale prototypes will then be used for fine tuning the operating parameters and for confirming the safety, efficacy, and usability of the device, both on the bench and in an in vivo animal study. In addition, FMD will have established a clear path through the next phases of development and commercialization. PUBLIC HEALTH RELEVANCE: Angioplasty, a minimally invasive catheterization procedure that opens a blocked coronary or peripheral vessel with a balloon and commonly a stent, has improved the outcome of patients with vascular disease. Our vibration guide wire platform technology will improve angioplasty of chronic blockages ("Chronic Total Occlusions") while maintaining the safety of these procedures, ultimately increasing the number of patients with chronic occlusions that can be safely treated with angioplasty.