Sensimmer Virtual Phaco Trainer for Cataract Surgery

描述（由申请人提供）：SENSIMMER“白内障手术虚拟超声训练器”是针对全球眼科住院医师项目市场（包括美国的118个项目）的硬件和软件解决方案。它是由美国小型企业公司ImmersiveTouch-Sensimmer Inc. （Westmont， IL）与伊利诺伊大学芝加哥分校（UIC）的手术模拟团队合作开发的，该团队由PI教授Pat Banerjee （ImmersiveTouch-Sensimmer总裁）领导。该虚拟培训师支持白内障超声乳化手术（“phaco”）的教学。第一阶段生产了一个撕囊训练机的原型，现在正在NEI-ARRA补充下进行完善。第二阶段建议创建一个超声乳化训练器，并对两个训练器进行验证。任务1。验证arra后I期撕囊模拟器。验证未在第一阶段获得资助。验证旨在显示撕囊术的外观、结构和并发效度。撕囊模拟器的评分系统包括撕囊过程中单独的钳子抓取晶状体囊膜的次数、钳子命中晶状体的次数以及总的撕囊时间。定性因素，如最佳大小和形状的荚膜撕裂和避免错误，如径向撕裂，角膜切口应力，角膜接触最近被添加。一个实时操作性能评分系统，并将其与模拟器性能相关联，仍然需要设计和验证。任务2。开发二期撕囊模拟器。第一阶段模拟器的目的是模拟一个标准的撕囊症进行验证。商业化将需要针对个体患者变化的II期撕囊模拟器。患者的差异会影响前囊和晶状体边缘的可见性或可及性（角膜混浊、玻璃体混浊、深置眼、前房深度、皮质性白内障），以及眼睛和晶状体囊的机械稳定性或材料特性（眼球不自主运动、后粘连=虹膜附着在晶状体上、弱小带、玻璃体高压、年轻人与老年人的囊膜厚度和易碎性、前囊钙化斑块）。任务3。研制超声乳化模拟器。受训者双手双脚并用：右手= phaco话筒；左手=核操纵器；右脚= phaco踏板；左脚=显微镜调整。将使用真实的脚踏板（例如爱尔康），phaco脚踏板将控制虚拟phaco头的三种模式：(1)灌溉；(2)灌溉+抽吸；(3)冲洗+抽吸+超声电源。SENSIMMER将在虚拟现实中模拟phaco尖端，并通过SensAble Phantom Omni触觉机器人的手柄模拟仪器手柄。培训师将能够模拟标准的外科手术技术（例如，phaaco chop; divide and conquer）和不寻常的临床病例（例如，弱带状瘤）。受训者将学习控制流体流量和超声波功率的速度。任务4。验证超声乳化模拟器。验证将再次以展示前面定义的面效、构念效和并发效度为目标。这就需要开发模拟和活体超声乳化术的评分系统。模拟超声乳化的评分系统将包括手术总时间、仪器尖端处理效率（以尖端总路径长度衡量）以及适当使用超声功率设置以避免角膜热损伤等因素。

DESCRIPTION (provided by applicant): The SENSIMMER" Virtual Phaco Trainer for Cataract Surgery is a hardware and software solution aimed at a worldwide market of ophthalmology residency programs (including 118 programs in the US). It is developed by the US small business concern ImmersiveTouch-Sensimmer Inc. (Westmont, IL), in collaboration with the surgery simulation team at the University of Illinois at Chicago (UIC) under PI Prof. Pat Banerjee, president of ImmersiveTouch-Sensimmer. The virtual trainer supports the teaching of cataract surgery by phacoemulsification ("phaco"). Phase I produced a prototype capsulorhexis trainer, now being perfected under an NEI-ARRA supplement. Phase II proposes to create a phacoemulsification trainer and to validate both trainers. Task 1. Validate post-ARRA Phase I capsulorhexis simulator. Validation was not funded in Phase I. Validation aims at showing face, construct, and concurrent validity of capsulorhexis. The scoring system of the capsulorhexis simulator includes the number of separate forceps grabs of the lens capsule membrane during capsulorhexis, the number of hits of the lens with the forceps, and the total time for the capsulorhexis. Qualitative factors such as optimal size and shape of the capsular tear and avoidance of errors such as radial tear, corneal incision stress, and corneal touches have recently been added. A system for scoring live operative performance and relating this to simulator performance still needs to be devised and validated. Task 2. Develop a Phase II capsulorhexis simulator. The Phase I simulator aims to simulate only a single standard case of capsulorhexis for verification. Commercialization will require a Phase II capsulorhexis simulator for individual patient variations. Patient variations can affect the visibility or accessibility of the anterior capsule and the rhexis edge (corneal opacity, vitreous opacity, deep set eye, anterior chamber depth, cortical cataract) as well as the mechanical stability or material properties of the eye and lens capsule (involuntary eye movement, posterior synechia = iris attached to lens, weak zonules, high vitreous pressure, capsular thickness and fragility in young vs. old, calcified plaque on anterior capsule). Task 3. Develop a phacoemulsification simulator. The trainee uses both hands and both feet: right hand = phaco handpiece; left hand = nucleus manipulator; right foot = phaco pedal; left foot = microscope adjustment. Real foot pedals (e.g., Alcon) will be used, and the phaco foot pedal will control three modes of the virtual phaco tip: (1) irrigation; (2) irrigation + aspiration; (3) irrigation + aspiration + ultrasound power. The SENSIMMER will simulate the phaco tip in virtual reality and model the instrument handle by the handle of the SensAble Phantom Omni haptic robot. The trainer will be capable of simulating standard surgical techniques (e.g., phaco chop; divide and conquer) and unusual clinical cases (e.g., weak zonules). The trainee will learn to control the rate of both fluid flow and ultrasonic power. Task 4. Validate the phacoemulsification simulator. Validation will again aim at demonstrating face, construct, and concurrent validity, as defined above. This will require developing scoring systems for both simulated and live phacoemulsification. The scoring system for simulated phacoemulsification will include factors such as total time for the operation, efficiency of instrument tip handling as measured by total tip path length, and appropriate use of phaco power settings to avoid thermal damage to the cornea. PUBLIC HEALTH RELEVANCE: ImmersiveTouch-Sensimmer, Inc. develops innovative augmented virtual reality software SENSIMMER" for surgical training of residents in such fields as neurosurgery and ophthalmology. In collaboration with the University of Illinois at Chicago, the Partnership proposes to develop and commercialize its training modules for cataract surgery. Following STTR Phases I and II, the SENSIMMER Virtual Phaco Trainer will include well developed modules for the two most difficult part-tasks of cataract surgery: capsulorrhexis and phacoemulsification.