前言导读
医用内窥镜是一种医疗器械，由可弯曲部分、光源及一组镜头组成，用于在内窥镜诊疗过程中提供通道、照明，并可以对体腔、中空器官和身体管道进行观察或操作，其经人体的天然孔道，或者是经手术做的小切口进入人体内。使用时将内窥镜导入预检查的器官，可直接窥视有关部位的变化，亦可用于手术或协助植入治疗性人工产品。
相较于传统医学，微创和无创的医学提高了诊治效率，减轻了患者痛苦，是医学技术发展的革命性进步，也预示着未来医学的发展方向。内窥镜设备常搭配内镜诊疗手术耗材使用，在内窥镜检查或手术中起到活检、止血、扩张、切除等作用。
医用内窥镜拥有一个庞大的产品体系，品类众多，按照镜体的软硬程度和应用场景，可以分为软性内窥镜和硬管内窥镜，按照应用领域划分，可以分为消化内镜、呼吸内镜、普通外科内镜、关节镜、脊柱内镜、泌尿外科内镜、胸外科内镜、妇科内镜、鼻咽喉科内镜等。其中，消化内镜主要包括胃镜、肠镜等。
医用内窥镜广泛应用于众多临床科室和应用场景，作诊疗用途。伴随着技术的进步，内窥镜的应用持续扩大至多个诊疗过程中，预期将推动全球对内窥镜的需求。
以内窥镜诊疗为代表的微创诊疗技术的出现，有效缓解了外科领域出血、疼痛和感染问题，现已成为我国医疗机构众多临床专业日常诊疗工作中不可或缺的重要技术手段。成为了当今疾病领域的一大亮点，其未来发展引人瞩目，也为合格并致力于改变现状的医疗器械从业者带来了可观的商业机遇。
市场概览
全球医用内窥镜市场是全球医疗器械市场增长最快的板块之一。根据弗若斯特沙利文相关报告，于2020年，全球医用内窥镜市场的价值为203亿美元，并估计于2030年将增至396亿美元。下图说明全球医用内窥镜市场的历史和估计市场规模：
根据弗若斯特沙利文相关报告，我国的医用内窥镜市场与全球医用内窥镜市场相比以较高的增长率增长，并预期维持较高的增长率。于2020年，中国的医用内窥镜市场价值为人民币231亿元，并估计于2030年增至人民币624亿元。下图说明中国医用内窥镜市场的历史及估计市场规模：
技术解读
医用内窥镜是一种集光学、人体工程学、精密仪器、现代电子、数学、软件等技术于一体的多学科系统。医用内窥镜通常由可进入人体的软管或硬管、捕获和传输患者内部组织器官图像的透镜成像系统、对捕获的图像进行数字化处理的图像处理系统、将数字化图像呈现给操作者或观察者的显示系统，以及传输光线以提高被检查区域的可见度的光源系统组成，在某些情况下，还包括一个额外的工作通道，为手术过程中使用的器械提供通路。
医用内窥镜主要包括供电模块、采集模块、光源模块以及处理模块等部分，其组成部分和工作原理如下附图所示：
然而现行的手术仍然需要通过光纤电缆连接到手术塔上，又是会绊倒使用者从而带来操作不便，更为严重的是这些电缆与患者烧伤和医疗相关感染(HAIs)有关，这会造成极大的医疗成本负担，严重甚至会造成病人死亡的隐患。
近日，FDA批准[敏感词]且[敏感词]无线内窥镜----ArthroFree，为内镜技术带来新的发展方向，ArthroFree通过消除手术塔组件（和连接电缆），在整个医疗保健系统中增加大量价值，通过提高手术室的安全性和效率来降低成本，引起了巨大反响。
另外，知名内窥镜厂商Endoluxe，同样推出一款无线内窥镜----Endoluxe eVS，其[敏感词]采用 TowerTech技术的高清无线内窥镜， TowerTech具有内置于摄像机的所有必要可视化功能，也引起了市场广泛关注。
对于本文，笔者以ArthroFree和Endoluxe eVS为典型代表，对无线内窥镜展开系统分析。
认识ArthroFree
ArthroFree系统来自于Lazurite公司，将其专有的低热、高强度Meridiem光引擎技术与先进的摄像头、电池和无线传输技术相结合，并与患者数据控制台、手术显示器和内窥镜相兼容。该系统旨在通过节省成本、提高能源效率和缩短设置/故障时间来提高手术室的生产率、患者安全性和经济价值。模块化系统还设计为与当前的手术室技术完全兼容。
ArthroFree无线系统旨在简化灭菌，减少设置和击穿时间，并消除手术塔上对光源和电源的需求。ArthroFree无线系统将消除光纤电缆的危险，以及外科助理对相机电缆管理的需求。
ArthroFree无线手术系统需要新的信号传输、电源和照明功能，因此，创建了Meridiem照明技术平台，Meridiem是一种固态、低热量、高效的照明系统，并且需要的能量只是同类有线摄像机系统的一小部分。
ArthroFree系统中使用的Meridem照明技术只需传统手术摄像机1%的功率即可获得可比的照明量，而且该平台和设计易于扩展，并且有望在医疗保健和其他行业建立新的节能照明标准。
专利分析
Lazurite对ArthroFree系统中和Meridem照明技术均进行了全方位的专利布局，笔者分别从ArthroFree系统中和Meridem照明技术涉及的相关专利中择机选择了2组专利进行了解析，相关结果如下，ArthroFree系统中和Meridem照明技术的完整专利清单笔者也汇总完成，如若获取完整专利清单和相关专利分析可以与笔者取得联系，共同交流学习：
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Wireless imaging system comprising a head unit and a light cable that comprises an integrated light source
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Modern endoscopic surgical procedures, which are generally considered quick and simple, actually require a lengthy preoperative period to set up the necessary equipment and require the use of a number of wires and cables that are often draped over patients and can hinder surgeons and their staff. Moreover, although state-of-the-art LED-based systems are more efficient than the older xenon lighting systems, which may use over 1000 watts of power, these newer light source units are still very power intensive, requiring 300 watts or more, most of which is wasted as heat or lost through light leaking from the external light cable. In addition, the wasted heat has been repeatedly cited as the source of operating room fires in cases where the cables were draped over a patient incorrectly or when the heated endoscope met a combustible material.
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A wireless imaging system comprising a head unit and a light cable is provided. The head unit comprises a head unit case, a head unit electrical connector, an image sensor, a wireless transceiver, a central processing unit, and a user-input component. The light cable comprises a light cable electrical connector, a power cable, and an integrated light source. The integrated light source comprises an emissive radiation source having a first spectrum, an optical element located to direct emissions from the emissive radiation source, a volumetric spectrum converter, and an optical reflector located about the converter. The converter converts emissions directed from the emissive radiation source to emissions having a second spectrum different from the first spectrum. The reflector reflects the converter emissions towards the output filter.
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For these reasons, the overall efficiency of the extant designs remains comparatively low, even when LD-based devices (the most efficient design) are analyzed. Furthermore, prior designs that use an LD to provide the primary light input completely saturate the remote phosphor elements. This over saturation can lead to the inadvertent emission of coherent laser light, which can cause damage to sensitive electronics, materials, eyes, and skin.
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An integrated light source includes: an emissive radiation source having a first spectrum; an optical element located to direct emissions from the emissive radiation source; a volumetric spectrum converter located to convert emissions directed from the emissive radiation source to emissions having a second spectrum different from the first spectrum; an optical reflector located about the converter; an output filter, the reflector being located to reflect the converter emissions towards the output filter; and a package body having an internal cavity containing the emissive radiation source, optical element, converter, reflector, and filter, wherein desired light radiates from the cavity through the filter.
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认识Endoluxe eVS
典型的传统内窥镜平台需要笨重的轮式底座塔、摄像头、摄像头处理器、光源、笨重的光缆、记录器、监视器以及从摄像头到监视器的易发生危险的电缆。借助 Endoluxe TowerTech™，所有必要的可视化特性和功能都方便地内置到该摄像头中。
Endoluxe eVS 的目标是消除昂贵、复杂和陈旧的传统内窥镜视频平台，以适应技术创新，提高程序采用、患者安全和临床结果。Endoluxe eVS 视觉系统提供了一种经济高效的解决方案，它将传统的基于推车的系统的所有功能整合到一个无线、便携式、手持设备中。
Endoluxe eVS 是适用于所有内窥镜手术的完美相机系统，这些手术利用行业标准的刚性和柔性模拟范围，如泌尿科、妇科、耳鼻喉科、普通外科和骨科。
Endoluxe eVS平台由Endoluxe Orb、Endoluxe 接收器和 Endoluxe 充电站组成。endoluxe orb 是一款便携式智能设备，集成了磁性光源、1080p 高清摄像头、全触摸显示屏以及用于连接领先的刚性或柔性模拟内窥镜的可靠连接方法。orb 与 Endoluxe 接收器无线通信以捕获图像和视频，同时流式传输到任何支持 HDMI 的远程显示器或云应用程序。除了这些功能之外，还有一个软件平台，它提供 QR 码集成工作列表、符合 HIPAA 标准的基于云的媒体存储、共享和流式传输，用于文档、患者教育、转诊和咨询。
专利分析
Endoluxe对该技术均进行了全方位的专利布局，笔者将涉及的相关专利中择机选择了2组专利进行了解析，相关结果如下，Endoluxe eVS技术的完整专利清单笔者也汇总完成，如若获取完整专利清单和相关专利分析可以与笔者取得联系，共同交流学习：
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System and methods for endoscopic imaging
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Accordingly, there exists a need for an inexpensive, lightweight, mobile platform that is both accurate and reliable, and does not require an excessive amount of time to assemble or to establish external connections or cables.
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A portable endoscopic inspection system comprises an endoscope having a proximal end with a flanged eyepiece for observation and a distal end with a lens assembly for insertion into a region of interest. A light port transports incident light to the region of interest along an lighting pathway, and reflected light is transported along an imaging pathway from the lens assembly to the eyepiece. A wireless imaging unit comprises a light source which detachably couples to the light port for generating the incident light, and an imaging sensor for recording images of the reflected light from the eyepiece. The wireless imaging unit comprises a variable coupling system which mechanically couples the imaging sensor to the flanged eyepiece independent of the shape and/or size of the flange of the eyepiece.
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System and methods for endoscopic imaging
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Accordingly, there exists a need for an inexpensive, lightweight, mobile platform that is both accurate and reliable, and does not require an excessive amount of time to assemble or to establish external connections or cables.
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A portable endoscopic inspection system comprises an endoscope having a proximal end with a flanged eyepiece for observation and a distal end with a lens assembly for insertion into a region of interest. A light port transports incident light to the region of interest along an lighting pathway, and reflected light is transported along an imaging pathway from the lens assembly to the eyepiece. A wireless imaging unit comprises a light source which detachably couples to the light port for generating the incident light, and an imaging sensor for recording images of the reflected light from the eyepiece. The wireless imaging unit comprises a variable coupling system which mechanically couples the imaging sensor to the flanged eyepiece independent of the shape and/or size of the flange of the eyepiece.
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结 语
目前，对于医用内窥镜设备而言，依然以国外企业为主，上述企业在一次性、4K、3D、特殊光医、超细等多个领域占据国内市场大部分份额，不过随着国内重视程度不断提高的情况下，中国公司蓄势待发，在一片被普遍看好的市场中开始暗流涌动，随着各个“卡脖子”技术不断攻克，国产医用内窥镜一定会在近几年实现重大突破和问世。
目前，国内各大医用内窥镜领域医疗厂商还会将奥林巴斯、卡尔史托斯、美敦力等重要竞品作为标杆和对照，但是随着各大国内厂商联动产学研医生多方力量，不断创新，必将推动中国医用内窥镜业更智能化、精准化、无线化的发展，也会逐步摆脱国外竞品带来的压力和技术障碍，不过，国外巨头公司和国内新兴企业在知识产权方面布局更加紧密，医用内窥镜赛道上的各个国内厂商之间的竞争也会更加激烈，届时相关知识产权问题也必将会成为各大医用内窥镜厂商的研究重点课题，后续相关产品的的研发和专利事务更加值得持续关注。
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