Developing Physics-Based Virtual Simulation Technology for Natural Orifice Transl

描述(由申请人提供)：为自然口腔内窥镜手术(NOTES)开发基于物理的虚拟仿真技术NOTES是一种新兴的革命性外科手术范式，被视为腹腔镜手术的自然继承者，通过插入自然开口(如口腔、肛门或阴道)的灵活内窥镜，通过穿孔内脏(胃、结肠或阴道)进入内脏，无需在身体表面切开任何伤口。这样的“无疤痕”手术不仅会带来更好的美容效果，还会增加减少伤口感染和切口疝气的前景，以及手术压力、术后固定和疼痛的可能性。然而，动物研究显示了严重的手术困难和术后并发症。因此，目前对笔记的热情不应超过对实施这项新技术的谨慎态度。在美国，在将钞票安全地引入人类之前，必须克服几个发展的基本障碍，包括：(1)找到进入腹部器官的最佳技术；(2)确保腹部内的压力不会上升到危险水平，或者在通过内窥镜将气体(空气或二氧化碳)泵入体腔(这被称为气腹，通过充气过程实现)以增加工作量时，不会泄漏到胃肠道；(3)保持体腔内的空间定向；(4)实现胃壁穿刺点的近乎完美的关闭(胃切开术)；(5)预防感染；(6)控制腹膜内出血；(7)开发新的器械；(8)新的训练方案。目前的模式是基于测试猪模型，这是耗时、资源密集型的，并且严重限制了可以测试的可能替代方案的数量。为了极大地加快笔记程序和设备的开发，我们提议开发第一个基于虚拟现实(VR)的笔记模拟器，具有视觉和触觉(触觉)反馈。虽然基于VR的模拟器既可以用于腹腔镜手术，也可以用于胃肠道内窥镜检查，但没有用于NOTES的模拟器。现有的技术不足以进行笔记模拟，必须克服胃肠道内窥镜检查或腹腔镜手术中未遇到的主要技术障碍。这些障碍中最重要的包括(1)基于物理实验的多层中空器官(如食道、胃、肠、直肠和阴道)的逼真建模；(2)灵活手术工具与软组织相互作用的模拟；(3)确保气腹的有效性和胃切开闭合的完整性的基于物理学的技术；以及(4)开发逼真的界面。本方案的目的是克服这些初步挑战，开发第一个VR-NOTES模拟器，它牢固地基于物理实验和手术经验，并对手术并发症的生理后果做出反应。模拟器必须经过广泛的验证才能在临床环境中使用。在一个为期4年的R01研究项目中，一个拥有基于物理的医学模拟、生物力学器官建模、人体因素工程学、介入胃肠病学、腹腔镜和妇科外科的集体专业知识的多学科团队已经组建起来，以实现以下具体目标：SA1)将最新的3D解剖模型与基于物理的组织变形模型相结合，以模拟灵活的手术工具与在NOTES手术中发生的详细的可变形器官模型的相互作用；SA2)整合SA1中产生的计算模型和实验数据，并开发虚拟笔记阑尾切除(阑尾切除)模拟器的原型，该模拟器结合了手术并发症的生理后果，并允许比较不同的手术程序和装置；和SA3)建立计算模型和在SA2中开发的VR-NOTES模拟器的有效性。 与公共卫生相关：这项研究的目标是开发基于计算机的技术，使外科医生能够开发一种革命性的“无疤痕”外科技术，在这种技术中，可以在体内器官上进行手术，而不需要在身体表面切开任何伤口，从而显著减少感染、术后疼痛和恢复时间。手术程序和技术在应用于患者之前以这种无风险的方式开发和完善，将转化为更少的手术室错误、减少患者发病率和改善患者结果，从而更快地愈合、更短的住院时间以及减少手术后并发症和治疗成本。

DESCRIPTION (provided by applicant): Developing Physics-Based Virtual Simulation Technology for Natural Orifice Translumenal Endoscopic Surgery (NOTES) NOTES is an emerging revolutionary surgical paradigm, being viewed as a natural successor of laparoscopic surgery, where internal organs are accessed by perforating the viscera (stomach, colon or vagina) using a flexible endoscope inserted through natural orifices such as the mouth, anus or vagina; without making any incisions on the surface of the body. Such "scarless" procedures would not only lead to better cosmetic results but also enhance the prospects of decreased wound infections and incisional hernia, as well as operative stress, postoperative immobility and pain. However, animal studies have shown serious interoperative difficulties as well as post operative complications. Hence, the current enthusiasm regarding NOTES should not overtake a cautioned approach to the implementation of this new technique. Before NOTES can be safely introduced to humans in the United States several fundamental barriers to its development must be overcome including (1) discovering optimal techniques for accessing the intra-abdominal organs; (2) ensuring that the pressure inside the abdomen does not rise to dangerous levels or there is no leakage into the GI tract when gas (air or CO2) is pumped into the body cavity (this is known as pneumoperitoneum and is achieved through a process known as insufflation) through the endoscope to increase work volume; (3) maintaining spatial orientation inside the body cavity; (4) achieving near perfect closure of the puncture site in the gastric wall (gastrotomy closure); (5) prevention of infection; (6) control of intra-peritoneal hemorrhage; (7) developing novel instrumentation and (8) novel training regimens. The current paradigm is based on testing porcine models which is time consuming, resource intensive and severely delimits the number of possible alternatives that can be tested. To vastly accelerate the development of NOTES procedures and devices, we propose to develop the first virtual reality (VR)-based NOTES simulator with both visual and haptic (touch) feedback. While VR-based simulators exist for both laparoscopic surgery and gastrointestinal endoscopy, none exists for NOTES. Existing technology is inadequate for NOTES simulation and major technological hurdles - not encountered in GI endoscopy or laparoscopic surgery - must be overcome. The most significant of these hurdles include (1) realistic modeling of multilayered hollow organs (e.g., esophagus, stomach, intestines, rectum and vagina) based on physical experiments; (2) simulation of the interaction of flexible surgical tools with soft tissues; (3) physics-based techniques of ensuring the effectiveness of pneumoperitoneum and the integrity of gastrotomy closure and (4) developing realistic interfaces. The aim of the present proposal is to overcome these preliminary challenges and develop the first VR-NOTES simulator which is firmly based on physical experiments and surgical experience and is responsive to physiological consequence of surgical complications. The simulator must undergo extensive validation before it can be used in a clinical setting. A multidisciplinary team with collective expertise in physics-based medical simulation, biomechanical organ modeling, human factors engineering, interventional gastroenterology, laparoscopic and gynecologic surgery has been assembled to achieve the following specific aims in a 4-year R01 research project: SA1) To combine the latest 3D anatomical models with physics-based tissue deformation models to simulate the interaction of flexible surgical tools with detailed deformable organ models that occur in NOTES procedures; SA2) To integrate the computational models and experimental data generated in SA1 and develop the prototype of a virtual NOTES appendectomy (appendix removal) simulator which incorporates physiological consequence of surgical complications and allows comparison of alternate surgical procedures and devices; and SA3) To establish the validity of the computational models and the VR-NOTES simulator developed in SA2. PUBLIC HEALTH RELEVANCE: The goal of this research is to develop computer-based technology that will allow surgeons to develop a revolutionary "scarless" surgical technique where operations on internal organs may be performed without making any incisions on the surface of the body leading to significantly reduced infections, post- operative pain and recovery time. Surgical procedures and techniques, developed and perfected in this risk- free manner before application to patients, will translate to fewer operating room errors, reduced patient morbidity and improved patient outcomes resulting in faster healing, shorter hospital stay and reduced post surgical complications and treatment costs.