Developing Physics-Based Virtual Simulation Technology for Natural Orifice Transl

描述（申请人提供）：开发基于物理的自然孔经腔内窥镜手术（NOTES）虚拟仿真技术NOTES是一种新兴的革命性外科手术模式，被视为腹腔镜手术的自然继承者，其中通过穿透内脏进入内脏（胃、结肠或阴道）使用柔性内窥镜通过自然孔道（如口腔、肛门或阴道）插入;而不在身体表面上做任何切口。这种“无疤痕”手术不仅会带来更好的美容效果，而且会增加减少伤口感染和切口疝以及手术压力、术后不动和疼痛的前景。然而，动物研究显示了严重的手术困难以及术后并发症。因此，目前对NOTES的热情不应超过谨慎的方法来实现这一新技术。在NOTES可以安全地引入美国人类之前，必须克服其发展的几个基本障碍，包括（1）发现进入腹腔内器官的最佳技术;（2）确保腹部内的压力不会上升到危险水平，或者当气体进入胃肠道时，（空气或CO2）被泵入体腔（这被称为气腹，并且通过被称为吹入的过程来实现）通过内窥镜以增加工作量;（3）保持体腔内的空间定向;（4）实现胃壁穿刺部位的近乎完美闭合（胃切开术闭合）;（5）预防感染;（6）控制腹膜内出血;（7）开发新型器械;（8）新型培训方案。 目前的范例是基于测试猪模型，这是耗时的，资源密集型的，并严格限制了可以测试的可能的替代品的数量。为了大大加快NOTES程序和设备的开发，我们建议开发第一个基于虚拟现实（VR）的NOTES模拟器，同时具有视觉和触觉（触摸）反馈。虽然腹腔镜手术和胃肠道内窥镜检查都有基于VR的模拟器，但NOTES却没有。现有技术不足以进行NOTES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）多层中空器官（例如，（2）模拟柔性手术工具与软组织的相互作用;（3）确保气腹有效性和胃切开术闭合完整性的基于物理的技术;（4）开发逼真的界面。本提案的目的是克服这些初步的挑战，并开发第一个VR-NOTES模拟器，这是牢固的物理实验和手术经验的基础上，并响应手术并发症的生理后果。模拟器在用于临床之前必须经过广泛的验证。 在基于物理学的医学模拟，生物力学器官建模，人因工程，介入胃肠病学，腹腔镜和妇科手术方面具有集体专业知识的多学科团队已经组建，以在4年的R 01研究项目中实现以下具体目标：SA 1）将最新的3D解剖模型与物理相结合-基于组织变形模型，以模拟柔性手术工具与发生在NOTES程序中的详细可变形器官模型的相互作用; SA 2）整合SA 1中产生的计算模型和实验数据，开发虚拟NOTES阑尾切除术的原型（阑尾切除）模拟器，其包含手术并发症的生理后果，并允许比较替代手术程序和器械;和SA 3）建立计算模型和在SA 2中开发的VR-NOTES模拟器的有效性。

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.