ESD

开展新技术新项目申请表

编号： 2012-02

拟开展技术

名 称 黏膜切除和黏膜剥离术（EMR+ESD） 考核期内拟开展例（或项）数 120

开展科室或诊疗组 消化内科 协作科室或诊疗组 病理科

主 持 人 熊俊光 职 称 副主任医师

技术类别 诊断检查类 □ 治疗康复类 □ 综合类 □

技术来源 引进 □ 改进 □ 创造 □

技术等级 国家级 □ 省级 □ 市级 □ 院级 □

发展方向 常规应用 □ 申报课题 □ 常规应用+申报课题 □

一、项目基本情况：

内镜下黏膜切除术（Endoscopic mucosal resection, EMR）是针对黏膜病变，如早期胃癌、伴有重度不典型增生的黏膜病变、大肠侧向发育型腺瘤、黏膜的可疑病变等，利用高频电切技术而进行的，将病变所在黏膜剥离而达到治疗目的或作大块组织活检而协助诊断目的的内镜下操作技术。

二、可行性分析（包括目的、意义、先进性、实用性、可产生的经济效益及推广前景等）：

内镜下黏膜切除术（Endoscopic mucosal resection, EMR）是针对黏膜病变，如早期胃癌、伴有重度不典型增生的黏膜病变、大肠侧向发育型腺瘤、黏膜的可疑病变等，利用高频电切技术而进行的，将病变所在黏膜剥离而达到治疗目的或作大块组织活检而协助诊断目的的内镜下操作技术。

基本的治疗器材类似于高频电切除术，主要为高频电发生器及电切圈套器等手控系统。可酌情选用钢丝带齿的圈套、针状切开刀、前端带有绝缘体的切开刀等特殊器械。备内镜下注射套管及肾上腺素、高渗盐水或生理盐水，应用配制成1:10 000的溶液。部分病例可能会使用到专用的、可套合于内镜前端的透明帽，其前端内边带有小沟槽，用时圈套钢丝可屈曲于沟槽内，当病变组织被吸入透明帽后再收紧钢丝，套住病变组织，然后退离透明帽，确认圈套合适后进行电切。术前准备同高频电切除术，由于需要实施该项手术时的创面往往较大，因而术前更应清楚患者的出凝血状态，如有异常，应先行纠正。为确保病变部位的完整切除，术前可于病变周边黏膜下注射美蓝或对周边黏膜应用高频电凝作为标志，然后于病变黏膜下注射1:10 000的肾上腺素生理盐水或高渗盐水溶液，将病变部位完全隆起后用圈套器对病灶进行一次性或分次切除，或借助透明帽将病变组织吸引后圈套、电切。黏膜下注射，一方面可将黏膜层抬起而利于安全地将病变所在的黏膜完整剥离，另一方面也有利于减少术后出血的危险。注射位点以利于圈套电切为选择，多选择近镜头端或其左右方，靶组织的周边正常黏膜处注射而使靶组织完全隆起，必要时可选择在远离镜端的靶组织的远侧进行黏膜下注射。尽量于一处注射而将靶组织完全隆起，以减少注射液流失的速度，必要时方进行多点注射。注射时注意靶组织能否完全隆起，如无法完全隆起，提示黏膜病变组织已有恶变，且已侵及黏膜下层，甚至固有肌层。如此时强行进行黏膜剥离术，一方面可能无法将病变组织完全清除，另一方面易于出现消化道穿孔。故当黏膜下注射后靶组织无法完全隆起（抬举征阳性）时，禁忌作黏膜剥离术，只单纯作活检并建议患者接受手术治疗。切出的标本应全部取出。分多次切除者，将标本取出后应尽量将其按原貌排列复原，固定后再送检，以便病理检查时能了解标本边缘的情况，尤其当切出来的组织有恶变情况时，复原后的标本对于判断恶变组织是否完全切除，以及制订进一步的治疗措施极为重要。

用　

ＥＳＤ技术沿着ｌＣ内核的小型化方向压缩Ｉ１０尺寸　

自０．５　ｍＣＭＯＳ工艺问世以来，Ｉ／　Ｏ的尺寸基本上没有发生什么变化。目　前，通过采用紧凑型的静电放电（ＥＳＤ）　设计技术，Ｉ／Ｏ可以与Ｉｃ内核一道被　压缩。　输人・输出晶体管是实现Ｉｃ内核内　部的小信号（以¨Ａ计）与电子子系统　周围的其他信号（以ｍＡ计）之间通信　所必需的元件：需要考虑对Ｉ／Ｏ晶体管　以减小Ｉｃ体积：这些晶体管　非常宽（达几百ｖｍ，而内核　中的晶体管仅宽１　ｇｕｎ左右）。　此外，可对Ｉｃ产量构成　威胁的静电放电也会形成高　达数安培的电流：因此，必　须在片上采取相应的ＥＳＤ保　护设计，从而导致芯片尺寸　变大。　要进行ＥＳＤ保护设计，　ＥＳＤ　Ｔｅｃｈｎｏｌｏｇｙ　Ｓｈｒｉｎｋｓ　Ｉ／Ｏｓ　在。稳流电阻的设置可通过硅片面积的　高教利用来完成。半导体公司从Ｉ／Ｏ尺　寸的缩小中获利：而Ｉ／０尺寸的缩小又　将导致Ｉｃ体积的缩小，从而使得每块　芯片能够生产出更多的ＩＣ（每块芯片，　因而能够增加１００美元甚至更多的收　人）。　这种新颖的设计解决方案采用了　运用分段器件设｝ｆ的后端稳流（ＢＥＢ）、　合并稳流电路布局（ＭＢＣ）和多触点　电路设计（ＭＦＴ）。　与传统技术相比，在典型的０．１　８　ｎｌＣＭＯＳ工艺中，ＢＥＢ、ＭＢＣ和ＭＦＴ　的组合能够产生以下结果：　●ＥＳＤ性能提高６０％　●电压钳位效率提高３０％　●接通电阻改进５０％　●面积性能提高１～２倍　硅芯片设计解决方案与ＣＭＯＳ工　艺完全兼容，无需进行工艺变更以及特　殊或额外的掩模＝这里，需要改变三种　传统的做法：　第一种改变就是要了解在提供片　上ＥＳＤ保护的时候并不需要有效面积　一的稳流或硅化物阻隔，而可以采用过程　后端元件（如触硅、触聚合物和硅化物　多晶硅）来形成一个稳流网络。这种方　法的关键是稳流电阻“分段　概念的引　就必须对大电流的静电放电日ｌ在ＤＥＢ器件的截面目中・通过插凡已建的电阻陛稳流网人：如图１和图２所示，采用多个并联　提供适当的稳流处理。传统　扩散具有抗Ｅｓ。性能＝‘顶视布局日。高电阻来形成一个通用的、具有低串联　的做法是在灵敏器件（多为　。　ＮＭＯＳ晶体管）中提供具有　有效硅问隙的稳流电阻。这　样做虽能解决问题，但却付　出了高昂的代价：稳流电阻　占用了很大的硅片面积，从　而增加了成本。　随着近期几种在硅芯片　上得到证实的设计创新方案　的出现，上述现象已不复存　电阻的抗ＥＳＤ器件。　

ESD 认证

ESD 认证即静电控制体系认证，类似于ISO的体系认证，第三方认证机构根据被认证方选用的标准进行审核，目前主要是ANSI/ESD S20.20体系（类似于ISO9001），审核时分两大部分，一是文件审核，还有就是现场审核，现场主要包括各种技术参数的实际测量确认，以确保整个控制体系符合标准要求。

一、 ESD认证的基础知识

1.什么是 ESD？

ESD是代表英文ElectroStatic Discharge 即"静电放电"的意思。ESD是本世纪中期以来形成的以研究静电的产生与衰减、静电放电模型、静电放电效应如电流热（火花）效应（如静电引起的着火与爆炸）及和电磁效应（如电磁干扰）等的学科。近年来随着科学技术的飞速发展、微电子技术的广泛应用及电磁环境越来越复杂，对静电放电的电磁场效应如电磁干扰（EMI）及电磁兼容性（EMC）问题越来越重视。

2.什么是 ESD20.20？

ESD20.20 标准的全称是ANSI/ESDS20.20，该标准是一个美国标准，但在北美、欧洲和亚洲都通行。 ESD20.20 标准是由ESDA（静电放电防护协会）全力推动的厂商认可标准，该协会是由电子元器件的制造、使用商组成的，主要有IBM，MOTOROLA 等公司，这些公司的OEM 工厂或供货商必须要通过ESDS20.20认证认可才能获取和保持OEM 和供应产品的资格。所以，可以认为ESD20.20 是一个买方认证标准，对于那些芯片、电子元器件、电源及转换器、显示屏的制造商而言，要成为知名品牌的供应商，ESD20.20近似于一个强制认证标准。

3.为什么需要 ANSI/ESDS20.20 认证？

ANSI/ESDS20.20 标准是由ESDA 编制的用于电子、电气、通讯业静电防护体系实施规范与指南。可以看作是企业潜在客户的特定要求。实施ANSI/ESDS20.20 标准的认证，可使有志于成为知名跨国企业供应商的本地企业，早于竞争对手满足顾客的要求，使自己立于主动位置。由知名公正的第三方认证机构实施现场的体系认证，可以公正、客观地证明企业在静电防护与控制体系建立与实施的适宜性、充分性和有效性；可以适当减少第二方认证所需的成本。

September, 2007 page 1 of 14 ESD Protection while Handling LEDs Application Note Introduction As LED’s become more efficient and more compact their sensitivity to ESD events is also increasing in the majority of cases. Despite a great deal of effort in the semiconductor industry in the past decade, ESD still affects production yields, manufacturing costs, product quality, product reliability, and profitability of all semiconductor devices, including LED’s. Industry experts have estimated average product losses due to static damage to range from 8-33 %1. The cost of the damaged device itself is often negligible, but if associated costs like repair and rework, shipping, labour and overhead are included, clearly there is a need to understand how to handle and process devices which are sensitive to ESD. This is what this application note is about. Fundamentals of ESD Controlling electrostatic discharge begins with understanding how electrostatic charge occurs in the first place. Electrostatic charge is most commonly created by the contact and separation of two materials, which is known as "tribo-electric charging." Figure 1: Principle of Triboelectric charge It involves the transfer of electrons between materials. When two materials are placed in contact and then separated, negatively charged electrons are transferred from the surface of one material to the surface of the other material. Which material loses electrons and which gains electrons will depend on the nature of the two materials. The material that loses electrons becomes positively charged, while the material that gains electrons is negatively charged. For example, a person walking across the floor generates static electricity as shoe soles contact and then separate from the floor surface. An electronic device sliding into or out of a bag, magazine or tube generates an electrostatic charge as the device's housing and metal leads make multiple contacts and separations with the surface of the container. While the magni-tude of electrostatic charge may be different in these examples, static electricity is indeed generated. September, 2007 page 2 of 14 MEANS OF GENERATION 10-25 % REL. HUMIDITY 65-99 % RH Walking across carpet 35000V 1500V Walking across vinyl tile 12000V 250V Worker at bench 6000V 100V Poly bag picked up from bench 20000V 1200V Chair with urethane foam 18000V 1500V Table 1: Typical voltage spike levels by different means of generation This process of material contact, electron transfer and separation is in reality a more complex mechanism than described here. The amount of charge created by tribo-electric generation is affected by the area of contact, the speed of separation, relative humidity, and other factors. Once the charge is created on a material, it becomes an "electrostatic" charge. This charge may be transferred away from the material, creating an electrostatic discharge, or ESD event (Voltage spike). Additional factors such as the resistance of the actual discharge circuit and the contact resistance at the interface between con-tacting surfaces also affect the actual charge that can cause damage. Table 1 shows typical voltage spike levels by different means of generation and relative humidity levels. ESD damage is usually caused by one of three events: direct electrostatic discharge to the device, electrostatic discharge from the device or field-induced discharges. Damage to an ESDS (electrostatic discharge sensitive) device by the ESD event is determined by the device's ability to dissipate the energy of the discharge or withstand the voltage levels involved. This is known as the device’s "ESD sensitivity”. Discharge to the Device An ESD event can occur when any charged conductor (including the human body) discharges to an ESDS device. The most common cause of electrostatic damage is the direct transfer of electrostatic charge from the human body or a charged material to the electrostatic discharge sensitive (ESDS) device. The model used to simulate this event is the Human Body Model (HBM). A similar discharge can occur from a charged conductive object, such as a metallic tool or fixture. The model used to characterize this event is known as the Machine Model (MM) HBM Model The Human Body Model is the most commonly used model for classifying device sensitivity to ESD and used by OSRAM-OS to classify their devices, acc. to JESD22-A114-E. The HBM testing model represents the discharge from the fingertip of a standing individual delivered to the device. It is modelled by a 100 pF capacitor discharged through a switching component and a 1.5 kΩ series resistor into the component. A typical Human Body Model circuit, as described in JESD22-A114-E, is shown in Figure 1. September, 2007 page 3 of 14