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: 10653251
• 负责人: Daniel Caleb Rucker
• 金额: $ 60.14万
• 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/10653251
• 关键词: Address; Animal Model; Animals; Clinical; Colectomy; Colon; Colonoscopes; Colonoscopy; Complex; Computer software; Custom; Databases; Devices; Diameter; Dissection; Elasticity; 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; Shapes; Surgeon; Surgical Instruments; System; Testing; Thinness; Tube; Validation; Work; clinical imaging; clinical translation; clinically significant; cost; design; design verification; dexterity; experimental study; improved; 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.

项目摘要/摘要 该提案的目的是创建灵活的可训式仪器鞘，使患者能够 目前，要接受侵入性手术，以接受微创内窥镜干预措施。 临床意义来自（1）结肠病变的高事件 - 有630万个结肠镜检查 每年有50％发现病变，（2）消除这些子集的困难（有挑战的人 由于常规内窥镜的灵巧性有限，尺寸，形状或位置）。这导致超过60,000 最好的内窥镜检查员表明的最佳内窥镜病变每年患有结肠病变的患者可以安全地证明 使用门诊内窥镜手术拆除，而他们接受了侵入性手术 其结肠的一部分（即收集手术）。这是由于最佳之间的敏捷差距而发生的 内窥镜医生和典型的内窥镜医生。我们的目标是用本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个新的可进入的鞘概念，可利用弹性不对称提供 结肠镜尖端的敏捷性。这种敏捷减少了消除挑战的困难 巨大的。我们受控的偏光，薄壁，类似管子的设备将足够小，可以通过 传统内窥镜端口，同时为手术仪器提供了大型开放式腔。 它的创新机械设计通过使用传统的拉力系，铰链和其他来实现这一目标 笨重的力传输元件有利于两个薄壁管的推力相互作用，它们弯曲 通过在其尖端处的刚度不对称区域的相互作用区域进行奖励。 我们的方法包括三个特定目标。 AIM 1解决了可通道的护套的构建 他们的致动系统。 AIM 2重点是通过物理接口控制台实现灵巧的物理控制， 和设备敏捷的优化。 AIM 3由体内和体内猪实验组成 该设备使新的内窥镜解剖的医生能够准确和效率相似 精英内窥镜检查员所表明的可以有效，安全地治疗上面提到的60,000名患者。这 该项目的终点将是在动物模型中已验证的设备，为快速奠定了阶段 成功完成此R01后的临床翻译。