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

项目摘要/摘要 这项提议的目标是创造灵活的可操纵的器械护套，使患者能够 目前正在接受侵入性手术，以接受微创内窥镜干预。 临床意义来自(1)结肠病变的高发--630万次结肠镜检查(fi 每年50%的fi病变，以及(2)移除其中一部分的困难(那些具有挑战性的 尺寸、形状或位置)，这是由于传统内窥镜的灵巧性有限。这导致超过60,000 在美国，每年有最好的内窥镜医生证明的结肠病变的患者可以安全地 用门诊内窥镜手术切除，而不是接受侵入性手术切除 他们的一段结肠(即结肠切除术)。这种情况的发生是因为最好的 内窥镜医生和典型的内窥镜医生。我们的目标是用这项提案中描述的新设备缩小这一差距。 我们工作中的创新是一种新的可控护套概念，它利用弹性不对称来提供 结肠镜顶端的灵巧。这种灵巧性降低了去除具有挑战性的病变内膜的难度。 从宏观上讲。我们的可控Defl可拆卸、薄壁、管状设备将足够小，可以通过 传统内窥镜的端口，同时为手术器械提供一个大的开放腔来通过。 其创新的机械设计通过省去传统的拉线、铰链和其他 体积较大的力传递元件有利于两个薄壁管的推拉相互作用，这两个薄壁管弯曲的圆柱体是相互作用的。 通过其顶端不对称的僵硬相互作用区域可移动。 我们的方法包括三个特定的fic目标。目标1涉及可转向护套的构造和 它们的驱动系统。目标2侧重于通过医生界面控制台实现灵活的医生控制， 和设备灵活性的优化。目标3由体外和体内猪实验组成，以证明 该设备使新接触内窥镜解剖的医生能够以类似的准确性和效率进行手术 精英内窥镜医生已经证明，可以有效和安全地治疗上述60,000名患者。这个 该项目的终点将是一个已经在动物模型中得到验证的设备，为快速 成功完成本R01版后的临床翻译。

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.