Next Generation Robotic System for Supervised-Autonomous Bowel Anastomosis

用于监督自主肠吻合术的下一代机器人系统

• 批准号: 10910494
• 负责人: Michael Harrison Hsieh
• 金额: $ 74.83万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10910494
• 关键词: 3-Dimensional; Address; Adoption; Anastomosis - action; Animals; Artificial Intelligence; Cardiac; Cardiac Surgery procedures; Cardiovascular system; Childhood; Clinical; Clinical Trials; Colectomy; Colon; Colorectal; Colorectal Cancer; Complex; Complication; Data; Endoscopes; Endoscopy; Ensure; Environment; Excision; Extravasation; Family suidae; Feasibility Studies; Goals; Gynecologic; Health; Hour; Human; Incidence; Intelligence; Intervention; Intestines; Laparoscopic Surgical Procedures; Malignant Neoplasms; Medical; Methods; Morbidity - disease rate; Operative Surgical Procedures; Optical Coherence Tomography; Outcome; Patients; Pediatric Surgical Procedures; Peripheral; Pilot Projects; Procedures; Quality of life; Reconstructive Surgical Procedures; Research; Robot; Robotics; Rupture; Safety; Scheme; Stenosis; Structure; Surgeon; Surgical sutures; System; Techniques; Technology; Telerobotics; Testing; Three-Dimensional Imaging; Time; Tissues; Training; Transplantation; Urologic Surgical Procedures; Visceral; Vision; Visual Fields; adjudication; curative treatments; ergonomics; experience; experimental study; first-in-human; functional improvement; gastrointestinal; imaging system; improved; in vivo; miniaturize; minimally invasive; mortality; next generation; novel; patient safety; preclinical study; prospective; robot assistance; robot control; robotic system; skills; soft tissue; success; technology development; teleoperation; tissue injury; tissue phantom; tool; urologic

Project Summary: The goal of this project is to establish a new medical robot and surgical paradigm to perform clinical colonic anastomosis with shared control. We will develop and evaluate novel miniaturized functional 3D imaging, artificial intelligence (AI) based real time soft tissue tracking, and fail-safe autonomous control strategies that enable first in human autonomous robotic soft tissue surgery. The long-term goal of this proposal is to reduce the complication rates and improve functional outcomes of bowel anastomoses and other soft tissue surgeries independent of surgeon’s experience. Anastomoses are critical and challenging procedures performed over a million times per year in the US. However, up to 19% of gastrointestinal anastomoses are complicated by leakage, strictures, and stenosis, and anastomotic complications significantly increase patient mortality up to ten times. Recent key advances in surgery such as progressively more minimally invasive surgery (MIS) and robot- assisted surgery (RAS) using a tele-operated da Vinci robot have not addressed the critical factors influencing anastomotic outcome, and the overall anastomotic complication rates remain unchanged. Autonomous robotic surgery systems have the potential to significantly improve efficiency, safety, and consistency over current tele- operated RAS. Autonomous robotic soft tissue surgery is yet to be demonstrated in humans due to a lack of (a) accurate 3D endoscopic vision, (b) robust markerless soft tissue tracking, and (c) fail safe autonomous control. To address the clinical need for autonomous robotic suturing platforms, we developed a supervised autonomous robotic system for guiding reconstructive bowel anastomosis. We propose to conduct first-in-human pilot studies of an autonomous robotic suturing platform. Because complications from bowel anastomoses can be catastrophic, we implement a stepwise gradual increase of complexity starting with open overstitching of the closure of a common enterotomy and building up to laparoscopic colectomy to ensure patient safety. We hypothesize that autonomous robotic soft tissue surgery is feasible in humans and will perform the task of laparoscopic colectomy with better accuracy and efficiency over current tele-robotic RAS technology. The following four specific aims will enable the development of this technology and demonstrate clinical feasibility. We will develop miniaturized functional 3D imaging and tissue health sensing (Aim 1), AI based markerless tissue tracking (Aim 2), fail-safe autonomous control strategies (Aim 3), and demonstrate first in human autonomous soft tissue surgery in the form of common enterotomy closures (Aim 4). Beyond intestinal anastomosis, adoption of this approach could be beneficial in all soft tissue MIS and RAS tasks requiring precision and maneuverability, including complex pediatric, urological, and cardiac surgery.

项目概要： 该项目的目标是建立一种新的医疗机器人和手术范例来执行临床结肠手术 我们将开发和评估新型微型功能性 3D 成像、人工吻合术。 基于智能（AI）的实时软组织跟踪和故障安全自主控制策略，使第一个 该提案的长期目标是减少人类自主机器人软组织手术的成本。 并发症发生率并改善肠吻合术和其他软组织手术的功能结果 吻合术是一项关键且具有挑战性的手术，与外科医生的经验无关。 在美国每年有 19% 的胃肠道吻合术发生复杂化。 渗漏、狭窄和狭窄以及吻合口并发症显着增加患者死亡率高达 10 手术方面最近取得的重大进展，例如微创手术 (MIS) 和机器人手术。 使用遥控达芬奇机器人的辅助手术（RAS）尚未解决关键影响因素 吻合结果和总体吻合并发症率保持不变。 与当前的远程手术系统相比，手术系统有可能显着提高效率、安全性和一致性。 由于缺乏 (a)，自主机器人软组织手术尚未在人类身上得到证实。 准确的 3D 内窥镜视觉，(b) 强大的无标记软组织跟踪，以及 (c) 故障安全自主控制。 为了满足自主机器人缝合平台的临床需求，我们开发了一种有监督的自主机器人缝合平台 用于重建肠吻合术的机器人引导系统我们建议进行首次人体试点研究。 因为肠吻合可能会引起并发症。 灾难性的，我们从开放的过度缝合开始逐步增加复杂性 关闭普通肠切开术并进行腹腔镜结肠切除术，以确保患者安全。 自主机器人软组织手术在人类中是可行的，并将执行以下任务 腹腔镜结肠切除术比当前的远程机器人 RAS 技术具有更高的准确性和效率。 以下四个具体目标将促进该技术的发展并证明临床有效性。 我们将开发小型化功能性 3D 成像和组织健康传感（目标 1）、基于人工智能的无标记技术 组织跟踪（目标 2）、故障安全自主控制策略（目标 3），并首次在人体中进行演示 以常见肠切开术闭合形式进行自主软组织手术（目标 4）。 吻合术，采用这种方法可能有益于所有需要的软组织 MIS 和 RAS 任务 精确性和可操作性，包括复杂的儿科、泌尿外科和心脏手术。