胶囊内镜GIVEN产品说明

CONFIDENTIAL PillCam®胶囊内镜内镜平台 胶囊内镜的引领者 庄昱洲 Business Development Manager, China Presenter Presentation Notes OVERVIEW SW REVIEW HANDS ON Not released and therefore still changing and we are still learning SW must be learned by trial and error, hands on practice is critical!!! Focus on how you will change your presentations, evaluations, and training CONFIDENTIAL 胶囊内镜的历史  1991 “Tiny Missile” concept 小型导弹概念 Gavriel Iddan, Paul Swain  1994 CMOS imaging (patent) CMOS 成像专利  1996 “Live pig transmissions”动物测试  1998 Given Imaging 成立并做出第一粒胶囊内视鏡  1999 自愿人体测试  2000 在2000年DDW 上第一次现场演示  2001 PillCam SB 获得FDA成人准证  2003 PillCam SB 获得FDA小童准证  2004 PillCam ESO 获得FDA准证  2006 PillCam COLON 获得CE准证  2007 PillCam ESO 2 获得FDA准证  2007 PillCam SB 2 获得FDA准证  至今巳用於超过1,000,000病人 CONFIDENTIAL Iddan G, Nature 2000;405:417 Appleyard M, NEJM 2001 Presenter Presentation Notes 最早有关胶囊内镜的论文 CONFIDENTIAL Given Imaging • 总部设於以色列 Yoqneam市 • 研发中心於以色列. • 生产位於以色列及爱尔兰 • 分公司设於 : – 美国 Atlanta (北美州总部) – 日本东京市(日本总部) – 新加坡 Singapore (亚州总部) – 德国Hamburg, Germany (欧州总部) – 法国 Paris, France – 澳州 Sydney, Australia • 全球分销於超过60个国家 Given Imaging 是 在美国 NASDAQ 全球市场上市公司 (GIVN) 以及以色列 Tel Aviv 股票交易所上市公司 Presenter Presentation Notes Given Imaging 在以色列的总部大楼 CONFIDENTIAL GI V EN GastroIntestinal 食道及肠道 Video 视频 Endoscopy 内窥镜 Presenter Presentation Notes GIVEN 名称的由来 CONFIDENTIAL 1999 20082000 2003 硬件 软件 胶囊 胶囊内视鏡演变过程 CONFIDENTIAL • 技术 – Pillcam SB2 第二代小肠胶囊 – Pillcam ESO2第二代食道胶囊 – Pillcam Colon 第一代大肠胶囊 – RAPID 6 RAPID 第六代软件平台 • Potential New Clinical Applications 潜在的新的临床应用 – Esophageal 食道 – Small bowel 小肠 – Colonic 大肠 新发展 CONFIDENTIAL PillCam® Disposable Capsule PillCam®一次性胶囊 RAPID® Workstation RAPID® 工作站 Given® Diagnostic System 胶囊内镜的诊断系统 Given® DataRecorder™ Given® 数据仪 Presenter Presentation Notes Given诊断系统的组成 CONFIDENTIAL PillCam 平台 ESO 食道胶囊 Small Bowel 小肠胶囊 Colon 大肠胶囊 CONFIDENTIAL SB 传感器 ESO 传感器 传感器 与数据记录仪 2C 型 传感器与数 据记录仪的 连接 数据记录仪 与座式充电 CONFIDENTIAL 数据记录仪2C 胶囊通信 LED 传感器接口 开关 充电接口 及 USB接口 电池电量LED 数据记录仪状态 LED 电池板 Presenter Presentation Notes 记录仪在无活动状态后15分钟自动关闭。按住开关1秒后打开，按住5秒后关闭。当电池电量少于10%时每5秒会有蜂鸣，低于25%时LED会闪烁 Auto shut-off after 15 minutes of inactivity. To Power on hold SW for 1 sec / Power off hold for 5 sec. Audible beep every 5 mins when battery is below 10%; also 25% LED will blink CONFIDENTIAL USB 线 警示 LED 电池状态 LED 充电器 LED 数据记录仪 2C 充电座 Presenter Presentation Notes 当将记录仪插入充电底座时应听到三声蜂鸣 充电座可用于四型记录仪：成人DR2,DR1.5和儿童DR2 和DR1.5 不得使用跨接连接器连接充电座，使用将可能导致过流过载，损毁保险丝 电池应在阴凉处保存，否则可能导致损坏并缩短使用寿命 改进后的DR2和电池能支持长时间视频 CONFIDENTIAL 传感器贴片的使用指导图 CONFIDENTIAL DR2记录仪腰带的固定 让受检者站直后，将记录仪腰带绑在受检者腰间 CONFIDENTIAL PillCam 小肠镜 SB 2 CONFIDENTIAL 11.4 mm 原有 PillCam SB 胶囊 PillCam小肠镜SB 和 PillCam小肠镜SB 2 • 大小相同 • 改良的光学罩 • 改良的光学元件 26.3 mm 新 PillCam SB2 胶囊 26.3 mm 11.4 mm CONFIDENTIAL SB 第一代  11mm x 26mm  单摄像头  每秒两帧  单鏡片  标准亮度调节  140°视野角  0-30mm 景深 SB 2 第二代  11mm x 26mm  单摄像头  每秒两帧 或 每秒四帧(欧洲)  三鏡片  先进自动亮度调节  156°视野角  0-30mm 景深 PillCam SB小肠胶囊 CONFIDENTIAL PillCam小肠胶囊参数对比 PillCam 参考工作距离(mm) 视野角 (ISO 8600-3) 景深 (mm) 覆盖面积 [mm2] 覆盖范围 比例 % SB 1 第一代 4.5 140 0-30 500 n/a SB 2 第二代 4.5 156 0-30 1,100 >100 CONFIDENTIAL 4.5mm 140° PillCam SB2 增加组织覆盖范围 156° PillCam SB 第一代 PillCam SB 2 第二代SB 1 CONFIDENTIAL >超过2倍的可视粘膜组织 PillCam SB PillCam SB 2 在RAPID5以上版本的读图软件中增加可视覆盖范围 CONFIDENTIAL PillCam SB 2 with RAPID 5 156º视野角及ALC 功能 PillCam SB and PillCam SB2 增大的视野角 AOV PillCam SB1 in USA (没有ALC) 140º视野角 CONFIDENTIAL PillCam SB and PillCam SB 2 增大的视野角 PillCam SB2 with RAPID 5 156o视野角 PillCam SB1i with 有 ALC 140o视野角 AOV CONFIDENTIAL 先进的图像质量 同一患者 Presenter Presentation Notes SB2 明显增加可视范围，景深加强，更具立体感 CONFIDENTIAL 先进的图像质量 同一患者 Presenter Presentation Notes SB2 明显增加可视范围，景深加强，更具立体感 CONFIDENTIAL SB 1 SB2 先进的图像质量 同一患者 CONFIDENTIAL 新一代食道胶囊 ESO  双摄像头  14帧/秒  单镜片  标准亮度控制  标准视野角140°  景深0-30 mm ESO 2  双摄像头  18帧/秒  三镜片  先进自动亮度调节  169°超宽视场角  景深 0-30 mm CONFIDENTIAL PillCam ESO 1 Vs ESO 2 CONFIDENTIAL PillCam ESO 2 食管炎 静脉曲张 CONFIDENTIAL  双摄像头  四帧/秒  规格: • 直径：与PillCam小肠胶囊相同 • 长度：比PillCam小肠胶囊长5mm Ø 11 m m 31 mm PillCam结肠胶囊  约9小时工作时间 CONFIDENTIAL 透明穹顶 光学镜头 摄像头 电池组 LEDs 大腸膠囊內鏡 Pillcam Colon 11mm x 31mm 每侧摄像头2 帧/秒 超宽视场角 156° 景深 0-30mm 电池工作时间 9h + 1h 睡眠模式 CONFIDENTIAL 31  胶囊在初次激活后将自动进入休眠3分钟以保 存电池电量  1小时后胶囊自动再次打开  检查前需要进行严格的肠道准备，检查中需按 指导服用促动力药物促进胶囊通过全结肠 PillCam 结肠胶囊休眠模式 CONFIDENTIAL 32 DataRecorder and RAPID®  阵列传感器(8片)  10GB 数据记录仪 (DR2C)  RAPID5分析软件  Given工作站  RAPID实时监视器 CONFIDENTIAL33 PillCam 结肠胶囊传感器贴片位置 CONFIDENTIAL 34  可直接检看结肠粘膜  无需镇静  无需插管  无需注气  无放射性  可进行家庭检查 (白天, 晚上, 周末)  可改善患者对结肠疾病筛检的顺应性 PillCam 大肠胶囊的优点 CONFIDENTIAL 回盲瓣 阑尾打开 痔疮 正常结肠胶囊图像 CONFIDENTIAL 结直肠肿瘤 CONFIDENTIAL PillCam 结肠胶囊与普通结肠镜 Courtesy Blair Lewis 结肠镜 PillCam结肠胶囊 CONFIDENTIAL 其他结肠胶囊发现 憩室 痔疮溃疡性结肠炎 CONFIDENTIAL 39 PillCam结肠胶囊的发现 CONFIDENTIAL RAPID®软件 •Report •And 与 •Processing处理、分析 •Imaging 图像 •Data 数据 CONFIDENTIAL41 Presenter Presentation Notes New Splash with new image for the PillCam Platform to be used on all software and as branding for some elements such as covers and cd sleeves/faces CONFIDENTIAL42 RAPID® 5 新功能  支持新一代 PillCam 胶囊  读片更快,  增加医生诊断信心  改良工作流程 Presenter Presentation Notes Bill starts RAPID 5 software strengthens Given Imaging’s record of innovation by further improving reading efficiency, diagnostic confidence, and workflow, thereby facilitating the integration of capsule endoscopy into daily clinical practice. This RAPID version supports PillCam COLON and the next generation of PillCam video capsules. CONFIDENTIAL43 •使用新PillCam 胶囊时显示更 佳效果 •使用RAPID5 的显示效果更佳. 配及新参数, 新形状 CONFIDENTIAL 支持 PillCam® COLON 大肠胶囊 双镜头 CONFIDENTIAL 支持 PillCam® COLON 大肠胶囊 DualView Presenter Presentation Notes More details on colon track later. Localization track colors are updated to synch with the new 3-color product line branding CONFIDENTIAL 支持 PillCam® COLON 大肠胶囊 四像视图 CONFIDENTIAL47 改善读片效率 Improved Reading Efficiency 标准读片模式 快速预览 v5 QuickView v5 图像调校功能 Image Adjustment 线上查询Help Center Presenter Presentation Notes RAPID 5 software enhancements facilitate reading and interpretation of PillCam capsule endoscopy videos. Standard Viewing Mode smoothes diagnostic review. QuickView allows fast preview of a small bowel or COLON video. Joystick provides comfortable video play control. Image Adjustment allows customization of image appearance to enhance visualization CONFIDENTIAL 改良的标准读片方式 RAPID5 使用 A-Mode 读片模式为标准. 使读片更流畅 在胶囊拍摄的图像变化少时, RAPID软件将把所有重 复的图像组合在一起演示 当图象不相同时, 图象分开地被显示。以确保不会丢 失信息。 在1,800 个病理学图象的研究上确认, 效果相等於以 人工式读片。 Presenter Presentation Notes The standard viewing mode smoothes diagnostic review for increased reading efficiency. Support Level 1: The software regulates rate of change in small bowel and COLON videos in order to make reading more comfortable. Using advanced algorithms,,RAPID 5 combines similar images rather than showing each one in sequence. Support Level 2: The RAPID 5 standard viewing mode adopts the Automatic Viewing Mode, introduced as an optional feature in RAPID 4, as the standard for reading PillCam videos. CONFIDENTIAL 快速预览QuickView v5 QuickView 在特别读取大肠片时有显注的作用 一般性典型预览只需几分钟 QuickView在读取小肠或大肠片时, 快速的预览相对突 出的图象。给医生显示出这个案的重点. Presenter Presentation Notes Allows fast preview of the video while highlighting images that may be of interest in the video stream. Support: Suspected colon polyps and colon lesions are now included in the selection criteria of QuickView v5. The QuickView function scans each frame to select significant images that may be of interest and presents the selected images in a short video to provide an overview of the case prior to full review.  A typical preview takes just a few minutes. CONFIDENTIAL50 图像调较功能 用户可改变图象显示参数 调整对比度, 色彩, 亮度 此功能也可用於以前版本 的影片 Presenter Presentation Notes IMAGE IS NOT UPDATED Allows customization of image appearance to enhance visualization Support Color, Sharpness and Brightness can be adjusted during video review A Blue Image feature adjusts the display color contrast to render a bluish image that may assist in the diagnostic process. CONFIDENTIAL51 蓝模式显示 • 放大颜色对比度 • 可帮助诊断过程 Presenter Presentation Notes REPLACE WITH CONFIDENTIAL52 Presenter Presentation Notes The ESO images are ESO 2. CONFIDENTIAL53 增加医生诊断信心 Lewis Score 评分 RAPID 图谱 Colon Track 结肠踪迹 Circumference 周长估测 Presenter Presentation Notes New and updated features in RAPID 5 further increase the diagnostic value of the PillCam Platform. Lewis Score provides an approximate measure of mucosal damage. RAPID® Atlas enables comparison of case image to reference images. Colon Track displays location of PillCam COLON capsule in colon sections. Circumference Scale for assessing a finding’s circumferential involvement. CONFIDENTIAL Lewis 评分 基于直接观看到的小肠粘膜情况，Lewis评分可以 帮助提供一种近似的小肠粘膜损伤测量 • 可以为不同诊断提供一个粗略的阀值 • 用于评估疾病状态时，不同医院间的交流或标准化 数据 • 可用于监测治疗进展 Presenter Presentation Notes The Lewis Score is an aid to diagnosis that provides an estimate of mucosal damage based on direct visual imaging of the small intestine not provided by current methodologies. Combined with other clinical parameters (symptoms, patient and family history, previous diagnostic tests, lab values), the score could provide a threshold for differential diagnosis and be used to monitor the progress of treatment. Support •An automated scoring system provides greater standardization of disease activity assessment. •Provides one more point of evaluation to assist in determining appropriate patient management. •The Lewis Score facilitates communication and standardization for assessing disease states before, during, and after treatment. •Monitoring therapy effectiveness with a standardized score has clinical value. Existing endoscopic scoring methods are hampered by only viewing certain sections of the small intestine and a lack of data evaluating prognostic significance with enough scientific integrity to be used as a primary study endpoint. Using images obtained from CE exams, The Lewis Index Score is designed to be disease neutral (can be used to assess extent of Crohn's, NSAIDs, Vasculitis and radiation enteritis). Studies are underway to assess extent of disease activity in patients with known Crohn's disease using the Lewis scoring method. The Lewis Index Score is planned to be exclusively incorporated as an integral part of the next version of Given's RAPID 5 CONFIDENTIAL Active after small bowel landmarks are selected Small bowel automatically divided into equal thirds: “Tertiles” Villi and ulcer data entered for worst findings per Tertile Stenosis data entered for whole small bowel CONFIDENTIAL RAPID Atlas Gross Bleeding Celiac disease Ulcers Arteriovenous malformation Tumor Bleeding CONFIDENTIAL57 自带RAPID®图谱 内容包括: 食道、小肠、 结肠病变 按不同类型 分类，方便 查找 超过300张 精选图片供 医师比对 Presenter Presentation Notes Provides side-by-side comparison of case image to atlas reference images. RAPID Atlas v5 adds colon pathologies, Lewis Score reference images and additional small bowel and esophageal images. Reference images are searchable by findings, anatomy, diagnosis, or Capsule Endoscopy Structured Terminology (CEST). Support: The RAPID Atlas is a peer-reviewed image library that is available in real time and is updated periodically. It enables side by side image comparison of a case image to atlas images, allowing users to compare their current findings to a selection of labeled, peer-reviewed reference images. CONFIDENTIAL 周长评估标尺 • 用于估算有关发现的周长 • 可以用于估算食管静脉曲张和小肠溃疡大小 CONFIDENTIAL 周长评估标尺 Circumference Scale 估测屈张静脉大小 用于Lewis评分时估 测溃疡的大小 CONFIDENTIAL60 大肠模型显示 “大肠模型提供显示盲肠,肝曲,脾曲” Presenter Presentation Notes This colon schematic provides an indication of the PillCam COLON capsule location based on flexure landmarks. Graphic may not be final. CONFIDENTIAL61 改良工作流程  快速DR2 解除处理  帮助中心  简化 DVD 刻录功能  多案例资料管理 Presenter Presentation Notes RECONSIDER REMOVING RAPID 5.2 FEATURES FOLLOWING MARKETING STAFF MEETING May 1 RAPID 5 simplifies and expedites procedure management and documentation of PillCam studies. Quick DataRecorder release allows faster re-use of the DataRecorder. Multi-study data transfer to and from USB devices simplifies study handling. Single-click DVD burning and zip functionality eases handling of RAPID studies. CONFIDENTIAL RAPID6 部分新功能简介 CONFIDENTIAL FICE: Flexible Intelligent Color Enhancement 富士专利合作技术 以软件光学染色方式帮助读片者观察组织面特征 ，增强血管分布结构 CONFIDENTIAL FICE- Flexible Intelligent Color Enhancement •帮助强化显示溃疡中心位点， 用以与食物残片区别 •帮助增加脉管系统和病变对比 度 CONFIDENTIAL PillCam 进度指示条 胶囊行进轨迹二维 定位图 PillCam 进度指示条 • 通过估测胶囊行进速度， 提供近似的病变距离，可 以帮助医生制定干涉治疗 的入口 • 提供胶囊通过小肠时间的 进度比例 CONFIDENTIAL 多图显示模式 马赛克视图 CONFIDENTIAL 马赛克视图 • 适用于所有类型胶囊 • 可作为视频连续播放，或滚动式播放 • 通过组图式显示，让读图者能在短时内察看出组织改 变 • 可作标记和获取缩略图 CONFIDENTIAL 病例管理 •用户自定义栏 •栏目选择和定制 •病例数据显示 CONFIDENTIAL Quick DR 2 Release Quick DataRecorder Release allows faster re-use of the DataRecorder Video Creation Options •OPTION A: Direct from DataRecorder (Download) •OPTION B: First copy data from DR (Quick DR 2 Release), then create video (Compilation) Presenter Presentation Notes Performing the raw data copy first does not reduce the compilation time. In Workstation models with long download times for COLON and SB videos, the DataRecorder can be freed without having to wait until the video is created. A default setting can be adjusted so that the raw data will first be copied to the Workstation and then compiled into a RAPID video. The DR can be removed for use after the raw data is copied; a process which takes about 15 minutes with the current DR 2 software and RAPID 6. CONFIDENTIAL 选购件 CONFIDENTIAL71 挎包式记录仪袋 便捷腰带式传感器 CONFIDENTIAL72 RAPID®实时显示与数据处理器 • 手持设备，实时显示高清 图像，帮助医生了解 PillCam胶囊检查情况 • 内含完整片RAPID Reader 阅读器，医生可 以直接使用它进行读片和 报告 • 医生可直接使用该设备进 行床边患者资料登记而无 需依赖工作站 CONFIDENTIAL (All capsules, even second generation, show round images.) RAPID Real-Time CONFIDENTIAL Given Imaging 对医学市埸的诚诺, 不断研发, 帮助病人 CONFIDENTIAL Agile 探路胶囊 CONFIDENTIAL CONFIDENTIAL 国际胶囊内镜年会 ICCE. Consensus Building Miami, March 2006 Paris, June 2006 国际胶囊内镜年会纲站 www.icce.info CONFIDENTIAL 临床资料 超过1000篇同侪评审文献 CONFIDENTIAL 专业教育, 支持及资讯纲站 CONFIDENTIAL 谢谢! Thank You! Slide Number 1 胶囊内镜的历史 Slide Number 3 Given Imaging Slide Number 5 胶囊内视鏡演变过程 新发展 Given® Diagnostic System�胶囊内镜的诊断系统 PillCam 平台 传感器 与 数据记录仪 2C 型 数据记录仪2C Slide Number 12 传感器贴片的使用指导图 DR2记录仪腰带的固定 Slide Number 15 PillCam小肠镜SB 和 PillCam小肠镜SB 2 PillCam SB小肠胶囊� PillCam小肠胶囊参数对比 Slide Number 19 Slide Number 20 Slide Number 21 Slide Number 22 Slide Number 23 Slide Number 24 � Slide Number 26 PillCam ESO 1 Vs ESO 2 PillCam ESO 2 PillCam结肠胶囊 大腸膠囊內鏡 Pillcam Colon PillCam 结肠胶囊休眠模式 DataRecorder and RAPID® PillCam 结肠胶囊传感器贴片位置 Slide Number 34 Slide Number 35 结直肠肿瘤 PillCam 结肠胶囊与普通结肠镜 其他结肠胶囊发现 Slide Number 39 RAPID®软件 Slide Number 41 RAPID® 5 新 功 能 配及新参数, 新形状 支持 PillCam® COLON 大肠胶囊 支持 PillCam® COLON 大肠胶囊 支持 PillCam® COLON 大肠胶囊 改善读片效率�Improved Reading Efficiency 改良的标准读片方式 快速预览 QuickView v5 图像调较功能 蓝模式显示 Slide Number 52 增加医生诊断信心 Lewis 评分 Slide Number 55 Slide Number 56 自带RAPID® 图谱 周长评估标尺 Slide Number 59 大肠模型显示 改良工作流程 RAPID6 部分新功能简介 FICE: Flexible Intelligent Color Enhancement Slide Number 64 PillCam 进度指示条 多图显示模式 马赛克视图 病例管理 Quick DR 2 Release 选购件 Slide Number 71 Slide Number 72 RAPID Real-Time Slide Number 74 Slide Number 75 Slide Number 76 国际胶囊内镜年会 �ICCE. Consensus Building 临床资料 专业教育, 支持及资讯纲站 Slide Number 80