Registered Ultrasound-Endoscope

注册超声内窥镜

• 批准号: 7993881
• 负责人: Sharif Razzaque
• 金额: $ 37.99万
• 依托单位: INNEROPTIC TECHNOLOGY, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-07-15 至 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7993881
• 关键词: Abdomen; Ablation; Address; Anatomy; Anesthesia procedures; Animals; Caliber; Clinical; Clinical Trials; Clinical effectiveness; Cognitive; Communities; Data; Devices; Doctor of Philosophy; Effectiveness; Endoscopes; Equipment; Evaluation; Eye; Family suidae; Feedback; Figs - dietary; Fluoroscopy; Future; Goals; Grant; Hand; Hepatobiliary; Human; Image; Imagery; Injury; Intervention; Life; Liver; Magnetism; Medical center; Mind; Monitor; Movement; Nature; Needles; Operating Rooms; Operative Surgical Procedures; Outcome; Participant; Patients; Performance; Phase; Physicians; Positioning Attribute; Procedures; Quantitative Evaluations; Relative (related person); Research; Research Ethics Committees; Risk; Safety; Slice; Space Perception; Structure; Surgeon; Surgical incisions; System; Technology; Testing; Time; Tissues; Training; Ultrasonic Transducer; Ultrasonography; Weight-Bearing state; efficacy testing; ergonomics; expectation; experience; flexibility; human subject; imaging modality; improved; instrument; meetings; minimally invasive; novel; phase 1 study; prototype; public health relevance; research and development; skills training; spatial relationship; stereoscopic; success; usability

DESCRIPTION (provided by applicant): The proposed project aims to facilitate the use of flexible laparoscopic ultrasound transducers during minimally invasive surgery (MIS) in order to reduce injury rates. During a standard laparoscopic procedure, the surgeon operates through small incisions in the abdomen while viewing the internal anatomy on a remote video monitor, creating an eye-hand-instrument spatial coordination problem. Because of this, many injuries occur during MIS procedures. Laparoscopic ultrasound provides a more thorough understanding of the anatomy, offering complementary anatomical information to the laparoscopic camera image and thereby decreasing the risk of injury. However, its use aggravates the inherent spatial coordination problem of conventional MIS, since the same anatomical features appear very differently between the two imaging modalities. Precisely placing interventional instruments such as needles becomes particularly difficult without extensive experience.This problem is addressed with the guidance system of this project, which shows the surgeon how his instruments are positioned with respect to features in the ultrasound scan. The dynamic stereoscopic imagery of the Phase I system shows the current position and orientation of the needle as well as its future trajectory, integrated with the live ultrasound image. Both needle and ultrasound scan are presented to the user in their actual spatial orientations. In Phase I, a prototype system was developed and its efficacy tested. The results were stunning: two expert users increased their placement accuracy from 60% without our guidance to 100% with it; while two novice users (who had never before held an ultrasound probe) improved from 5% accuracy without our guidance to 100% with it. In other words, the novice users were not able to place the needle into a feature in the LUT video without our system, and with it they could not miss. In this Phase II project, we propose to (1) investigate new capabilities that will increase the usefulness of the system; and (2) to continue refinement of the prototype so that, at the project's conclusion, it will be ready for clinical trials with human subjects. It will be tested both quantitatively and qualitatively in multiple animal studies. We will also test its usability in a clinical setting, as well as experimentally evaluate the usefulness of the novel features developed throughout Phase II. PUBLIC HEALTH RELEVANCE: We propose to develop an advanced stereoscopic visualization system for minimally-invasive surgery that facilitates the use of laparoscopic ultrasound during MIS interventions, in order to reduce patient injury rates. The system offers three-dimensional guidance for accurate placement of needles or other interventional instruments into structures seen in the laparoscopic ultrasound image, so that the surgeon can conduct the procedure more easily and more safely.

描述（由申请人提供）：拟议的项目旨在促进在微创手术（MIS）期间使用柔性腹腔镜超声传感器的使用，以降低伤害率。在标准的腹腔镜手术过程中，外科医生通过腹部的小切口进行操作，同时在远程视频监视器上查看内部解剖结构，从而造成了眼神吸引人的空间协调问题。因此，在MIS手术过程中发生了许多伤害。腹腔镜超声提供对解剖结构的更透彻的了解，为腹腔镜摄像头图像提供了互补的解剖信息，从而降低了受伤的风险。然而，它的使用加剧了常规错误的固有空间协调问题，因为两种成像方式之间相同的解剖特征看起来非常不同。没有丰富的经验，该项目的指导系统解决了这一问题，这表明外科医生如何将其工具定位在超声扫描中的功能中，这表明了外科医生如何定位外科医生。 I期系统的动态立体图像显示了针头的当前位置和方向以及其未来轨迹，并与实时超声图像集成在一起。针和超声扫描都以实际的空间取向呈现给用户。在第一阶段，开发了原型系统并测试了其功效。结果令人惊叹：两名专家用户将其放置精度从60％提高到我们的指导，而不是100％。尽管有两个新手用户（从未进行过超声探测器）在没有我们的指导下提高了5％的准确性，从而提高了100％。换句话说，没有我们的系统，新手用户无法将针头放入LUT视频中的功能，因此他们不会错过。在此II阶段项目中，我们建议（1）研究将增加系统实用性的新功能； （2）继续完善原型，以便在项目的结论中，它将准备好与人类受试者进行临床试验。它将在多个动物研究中进行定量和质量测试。我们还将在临床环境中测试其可用性，并通过实验评估整个II期的新型特征的实用性。 公共卫生相关性：我们建议开发一种先进的立体可视化系统，以减少侵入性手术，以促进在MIS干预过程中使用腹腔镜超声检查，以降低患者的损伤率。该系统提供了三维指南，可将针或其他介入仪器准确地放置在腹腔镜超声图像中看到的结构中，以便外科医生可以更轻松，更安全地进行过程。