Sensimmer Virtual Phaco Trainer for Cataract Surgery

描述(申请人提供)：SENSIMMER“用于白内障手术的虚拟Phaco培训器是一种硬件和软件解决方案，目标是全球眼科住院医师项目(包括美国的118个项目)市场。它是由美国小型企业ImmersiveTouch-Sensimmer Inc.(伊利诺伊州韦斯特蒙特)与伊利诺伊大学芝加哥分校(UIC)的手术模拟团队在ImmersiveTouch-Sensimmer总裁派教授Pat Banerjee的领导下开发的。该虚拟教练员支持白内障超声乳化手术的教学。第一阶段生产了撕囊训练器的原型，现在正在NEI-ARRA的补充下完善。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后第一阶段撕囊模拟器。验证不是在第一阶段资助的，验证的目的是显示面孔、结构和撕囊的同时有效性。撕囊模拟器的评分系统包括撕囊过程中晶状体囊膜的分离钳子抓取次数、钳子击中晶状体的次数和撕囊的总时间。最近增加了一些定性因素，如最佳的囊膜撕裂大小和形状以及避免放射状撕裂、角膜切开应力和角膜接触等错误。仍然需要设计和验证一种用于对现场手术性能进行评分并将其与模拟器性能相关联的系统。任务2.开发第二阶段撕囊模拟器。第一阶段模拟器的目标是只模拟单个标准的撕囊病例进行验证。商业化将需要针对个别患者的第二阶段撕囊模拟器。患者的差异可能会影响前囊和睫状体边缘的可见性或可及性(角膜混浊、玻璃体混浊、深陷眼、前房深度、皮质性白内障)，以及眼和晶状体囊的机械稳定性或材料特性(非自愿眼球运动、虹膜后粘连=虹膜附着在晶状体上、弱透明带、高玻璃体压力、囊袋厚度和脆性，年轻人和老年人的前囊有钙化斑块)。任务3.研制超声乳化手术模拟器。学员使用双手和双脚：右手=超声乳化手柄；左手=核操纵器；右脚=超声乳化踏板；左脚=显微镜调整。将使用真实的脚踏板(例如，Alcon)，而超声乳化脚踏板将控制虚拟超声乳化尖端的三种模式：(1)冲洗；(2)冲洗+抽吸；(3)冲洗+抽吸+超声波功率。SENSIMMER将在虚拟现实中模拟超声乳化尖端，并通过可感知的Phantom Omni触觉机器人的手柄来模拟仪器手柄。该训练员将能够模拟标准的手术技术(例如，超声乳化；分而治之)和不寻常的临床病例(例如，弱透明带)。学员将学会控制流体流动和超声波功率的速度。任务4.对超声乳化模拟器进行验证。验证将再次以展示面子、结构和同时有效性为目标，如上所述。这将需要开发模拟和现场超声乳化手术的评分系统。模拟超声乳化术的评分系统将包括以下因素：手术总时间、以总针尖路径长度衡量的器械针尖处理效率，以及适当使用超声乳化功率设置以避免对角膜的热损伤。 与公共卫生相关：ImmersiveTouch-Sensimmer，Inc.为神经外科和眼科等领域的住院医师的手术培训开发创新的增强虚拟现实软件SENSIMMER。该合作伙伴计划与芝加哥的伊利诺伊大学合作，开发其白内障手术培训模块并将其商业化。在STTR第一阶段和第二阶段之后，SENSIMMER虚拟人工晶状体训练器将包括针对白内障手术中最困难的两个任务：晶状体撕裂和超声乳化手术的精心开发的模块。

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.