I-Corps: A steerable microcatheter that utilizes a miniaturized actuator to achieve a maximum range of motion

这个i-Corps项目的更广泛的影响/商业潜力是改善美国每年接受机械血栓切除术的4.5万名缺血性中风患者的预后。机械血栓切除术是通过解除阻塞的血管来重建脑血流的行为，是符合条件的患者的主要治疗方法。在到达梗阻时，曲折的解剖可能会导致手术失败和不良结局。可导向的微导管已经被开发出来，以增加成功结果的机会。目前可用的可引导导管拉动其转向机构的钢丝，这些钢丝贯穿导管的整个长度。对于长而曲折的解剖结构，钢丝和导管护套之间的摩擦力会急剧增加，从而减少尖端的运动范围。随着导管直径缩小以接近更窄的血管(直径小于2 mm)，与相对面积成正比的摩擦力急剧增加，使导管无法操作。此外，由于精度要求，这种规模的传统制造变得具有挑战性或昂贵得令人望而却步。这项拟议的技术是一种微导管，可以绕过这一限制，并保持其可操纵性，而不受导管路线的影响。这个i-Corps项目基于开发一种可操控的微导管，它利用一个微型致动器来实现最大的运动范围(在3D空间中360度)。它既使用了驱动机制，也使用了一种新颖的制造方法。驱动机构完全避免了摩擦，允许其运动范围与路径曲折无关。此外，该制造方法基于激光微加工层的叠层组装，从而实现了亚毫米精度的高通量制造。其结果是提供了一个技术平台，用于以前所未有的规模开发精确、可操控的微型导管。这种360度定向导管也可以由遥控机器人系统操控。随着5G传输能力变得容易获得，未来中风血栓摘除术可能会在移动设备中进行，而拟议的导管是由医生远程操作的。这一奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this I-Corps project is to improve outcomes for the 45,000 yearly ischemic stroke patients undergoing mechanical thrombectomy in the US. Mechanical thrombectomy, the act of reestablishing cerebral blood flow by relieving an obstructed blood vessel, is the primary treatment for qualifying patients. In reaching the obstruction, tortuous anatomy could lead to procedure failure and poor outcomes. Steerable microcatheters have been developed to increase the chances of a successful outcome. Currently available steerable catheters pull wires for their steering mechanism, these wires travel the entire length of the catheter. For long, tortuous anatomies, the friction between the wire and the catheter sheath increases drastically reducing the tip's range of motion. As the catheter diameter is scaled down to access narrower blood vessels (below 2 mm in diameter), friction, which is proportional to relative area, increases dramatically, making the catheter inoperable. Moreover, conventional fabrication at this scale becomes challenging or prohibitively expensive due to precision requirements. The proposed technology is a microcatheter to bypass this limitation and retain its steerability independent of the catheters course.This I-Corps project is based on the development of a steerable microcatheter that utilizes a miniaturized actuator to achieve a maximum range of motion (360 degrees in 3D space). It uses both a actuation mechanism as well as a novel fabrication approach. The actuation mechanism avoids friction altogether, allowing for its range of motion to be independent of path tortuosity. In addition, the fabrication method is based on laminate assembly of laser micro-machined layers, which results in high-throughput manufacturing of devices with sub-millimeter precision. The result is a technology platform for developing accurate, steerable, miniature catheters at an unprecedented scale. This 360 degree directional catheter also may be piloted by a remote-controlled robotic system. With 5G transmission capabilities becoming readily available, in the future, stroke thrombectomies may be carried out in mobile units, while the proposed catheter is piloted by a physician remotely.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.