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

通过经内窥镜可操纵器械鞘拯救患者免遭侵入性结肠切除术

• 批准号: 10522707
• 负责人: Daniel Caleb Rucker
• 金额: $ 62.54万
• 依托单位: UNIVERSITY OF TENNESSEE KNOXVILLE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10522707
• 关键词: Address; Animal Model; Animals; Caliber; Clinical; Colectomy; Colon; Colonoscopes; Colonoscopy; Complex; Computer software; Custom; Databases; Devices; Dissection; Elements; Endoscopes; Excision; Family suidae; Future; Geometry; Goals; Incidence; Intervention; Intestines; Intuition; Lesion; Literature; Location; Malignant Neoplasms; Mechanics; Modeling; Motion; Operative Surgical Procedures; Outpatients; Patients; Physicians; Polyps; Procedures; Property; Public Health; Robotics; Savings; Shapes; Surgeon; Surgical Instruments; System; Testing; Thinness; Tube; Validation; Work; base; clinical imaging; clinical translation; clinically significant; cost; design; dexterity; experimental study; in vivo; innovation; instrument; minimally invasive; nitinol; porcine model; prototype; safety and feasibility; standard of care; tool; transmission process

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.

项目概要/摘要 该提案的目标是创造灵巧的可操纵器械鞘，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。 临床意义来自于 (1) 结肠病变发生率高——有 630 万例结肠镜检查 每年有 50% 的人发现病变，以及 (2) 去除其中一部分的困难（那些具有挑战性的病变） 由于传统内窥镜的灵巧性有限，无法识别尺寸、形状或位置）。这导致超过 60,000 在美国，每年有数名患有结肠病变的患者，最好的内窥镜医生已经证明可以安全地进行治疗 通过门诊内窥镜手术切除，而是进行侵入性手术以切除 结肠的一部分（即结肠切除手术）。发生这种情况是因为最好的人之间的灵巧性差距 内窥镜医师和典型内窥镜医师。我们的目标是通过本提案中描述的新设备来缩小这一差距。 我们工作的创新是一种新的可操纵护套概念，它利用弹性不对称性来提供 结肠镜尖端的灵巧性。这种灵巧性降低了去除具有挑战性的内皮病变的难度 目视地。我们的可控偏转、薄壁、管状装置将小到足以穿过 传统内窥镜的端口，同时提供一个大的开放管腔供手术器械通过。 其创新的机械设计通过放弃传统的拉线、铰链和其他部件来实现这一点 庞大的力传输元件有利于两个薄壁管的推拉相互作用，这些薄壁管弯曲 通过其尖端处刚度不对称的相互作用区域可操纵。 我们的方法包括三个具体目标。目标 1 解决可操纵护套的构造和 他们的驱动系统。目标 2 侧重于通过医生界面控制台实现医生的灵巧控制， 以及设备灵活性的优化。目标 3 由离体和体内猪实验组成，以证明 该设备使刚接触内窥镜解剖的医生能够以与内窥镜解剖类似的准确性和效率进行操作 精英内窥镜专家已经证明可以有效、安全地治疗上述 60,000 名患者。这 该项目的终点将是一种已在动物模型中得到验证的设备，为快速 成功完成 R01 后的临床转化。