Saving patients from invasive colectomies via trans-endoscopic steerable instrument sheaths

项目总结/摘要 该提案的目的是创建灵巧的可操纵器械鞘管，使患者能够 目前都要接受侵入性手术以接受微创内窥镜介入。 临床意义来自（1）结肠病变的高发病率-有630万次结肠镜检查 每年50%的发现病变，和（2）去除这些子集的困难（那些具有挑战性的 尺寸、形状或位置）。这导致超过60，000 在美国，每年有1000例结肠病变患者，最好的内窥镜医生已经证明可以安全地 通过门诊内窥镜手术移除，而不是进行侵入性手术以移除 结肠的一部分（即结肠切除术）。这是因为最好的之间的灵巧差距 内窥镜医师和典型内窥镜医师。我们的目标是用本提案中描述的新设备来缩小这一差距。 我们工作中的创新是一种新的可操纵鞘管概念，该概念利用弹性不对称性提供 结肠镜尖端的灵巧这种灵活性降低了去除具有挑战性的病变的难度， 用肉眼观察。我们的可控可偏转、薄壁、管状装置将小到足以通过 传统内窥镜的端口，同时提供用于手术器械穿过的大的开放腔。 其创新的机械设计通过免除传统的拉线，铰链和其他 大体积的力传递元件有利于两个薄壁管的推拉相互作用，这两个薄壁管弯曲， 可通过在其尖端处的刚度不对称的相互作用区域来控制。 我们的方法包括三个具体目标。目标1涉及可控鞘管的构造， 他们的驱动系统。目标2侧重于通过医生界面控制台实现灵巧的医生控制， 和优化装置灵活性。目的3包括离体和体内猪实验，以证明 该器械使初次进行内镜解剖的医生能够以类似于 精英内窥镜医生已经证明可以有效、安全地治疗上述60，000名患者。的 该项目的终点将是一种已在动物模型中验证的设备，为快速 成功完成本R 01后的临床翻译。

Project Summary/Abstract The objective of this proposal is to create dexterous steerable instrument sheaths that enable patients who currently are subject to invasive surgeries to receive minimally invasive endoscopic interventions. Clinical significance comes from (1) the high incidence of colon lesions – there are 6.3 million colonoscopies per year with 50% finding lesions, and (2) the difficulty of removing a subset of these (those with challenging sizes, shapes, or locations) due to the limited dexterity of conventional endoscopes. This results in over 60,000 patients per year in the USA with colon lesions that the very best endoscopists have demonstrated can be safely removed with an outpatient endoscopic procedure, who are instead subjected to invasive surgery to remove a section of their colon (i.e. colectomy surgery). This occurs because of the dexterity gap between the best endoscopists and typical endoscopists. We aim to close this gap with the new device described in this proposal. The innovation in our work is a new steerable sheath concept that harnesses elastic asymmetry to provide dexterity at the tip of a colonoscope. This dexterity reduces the difficulty of removing challenging lesions endo- scopically. Our controllably deflectable, thin-walled, tube-like device will be small enough to pass through the port of a conventional endoscope, while providing a large open lumen for surgical instruments to pass through. Its innovative mechanical design accomplishes this by dispensing with conventional pull-wires, hinges, and other bulky force transmission elements in favor of the push-pull interaction of two thin-walled tubes, which bend con- trollably via interacting regions of stiffness asymmetry at their tips. Our approach consists of three Specific Aims. Aim 1 addresses the construction of the steerable sheaths and their actuation systems. Aim 2 focuses on enabling dexterous physician control via a physician interface console, and optimization of device dexterity. Aim 3 consists of ex vivo and in vivo porcine experiments to demonstrate that the device enables physicians new to endoscopic dissection to perform with accuracy and efficiency similar to what elite endoscopists have shown can effectively and safely treat the 60,000 patients mentioned above. The endpoint of this project will be a device that has been validated in an animal model, setting the stage for rapid clinical translation after successful completion of this R01.