3D Single Fiber Endoscope for Minimally Invasive Surgeries

用于微创手术的 3D 单纤维内窥镜

• 批准号: 8250980
• 负责人: Jason Geng
• 金额: $ 15.02万
• 依托单位: XIGEN, LLC
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-15 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8250980
• 关键词: Abdomen; Affect; Algorithms; Area; Balloon Angioplasty; Caliber; Cardiology; Client satisfaction; Clinical; Clinical Research; Collaborations; Color; Computational Science; Computer software; Confined Spaces; Data; Decision Making; Development; Devices; Diagnosis; Diagnostic; Economics; Endoscopes; Endoscopy; Engineering; Family suidae; Fiber; Goals; Health system; Hip Joint; Housing; Human; Image; In Vitro; Intervention; Knee; Labyrinth; Lasers; Lead; Light; Location; Lung; Magnetic Resonance Imaging; Malignant Neoplasms; Measurement; Mechanics; Medical; Methods; Nose; Operative Surgical Procedures; Ophthalmologic Surgical Procedures; Optic Nerve; Optics; Oral cavity; Otolaryngology; Patient Care; Pharmaceutical Preparations; Phase; Positioning Attribute; Postoperative Pain; Procedures; Process; Recording of previous events; Recovery; Rectum; Research; Research Personnel; Resolution; Risk; Scanning; Shoulder; Signal Transduction; Sinus; Site; Skin; Small Business Innovation Research Grant; Solutions; Spottings; Study Section; Surface; Surgical incisions; System; Technology; Testing; Three-Dimensional Image; Three-Dimensional Imaging; Time; Tissues; Tooth structure; United States National Institutes of Health; Universities; University Hospitals; Washington; Work; base; cost; design; experience; flexibility; image guided intervention; innovation; instrument; middle ear; minimally invasive; novel; prevent; prototype; repaired; research study; response; sensor; skull base; tool; two-dimensional; visual feedback

DESCRIPTION (provided by applicant): The primary objective of this SBIR effort is to develop a novel ultrathin (1~2 mm in diameter) scanning fiber endoscope (SFE) with simultaneous 2D/3D surface imaging capability. The proposed 3D-SFE will be able to provide, for the first time, dense 3D XYZ surface data that is co-registered with its 2D RGB counterpart, making 3D imaging an inherent part of SFE imaging capability without requiring users to perform any special manipulations or to take multiple images. The novel 3D imaging capability would greatly enhance the functionality of the existing SFE and enable it to perform, with its miniature probe size of 1~2 mm in diameter, a broad range of minimally invasive surgery procedures that were previously impossible to do. Unique features of the proposed novel 3D-SFE are: 7 High resolution full color 2D video image; 7 Unprecedented 3D imaging capability, with simultaneous and co-registered 2D and 3D image acquisition, possibly at video rate; 7 Single fiber scanner to generate stereo 3D images. 7 Dynamically adjustable field of view and image resolution; 7 Miniature size of the endoscope (~1 mm in diameter); 7 Extreme flexibility; and 7 Powerful 2D/3D image processing capability for minimally invasive surgeries. Xigen LLC proposes this comprehensive SBIR project, based on our strong collaborations and partnership with leading researchers/clinicians in multiple universities and hospitals. The Xigen team has long history and proven experience of attacking significant yet difficult 3D imaging problems in biomedical applications. Working closely with the research and clinical teams at the University of Washington who have developed multiple versions of working 2D scanning fiber endoscopes, we will develop full scale design, algorithms, hardware, software, and packaging for the 3D-SFE system, making it an integrated endoscopic image-guided system for minimally invasive surgeries that can access many sites that is currently impossible for existing endoscopes to do due to its ultra-thin diameter. This SBIR support will support thorough optical design, opto-electro-mechanical engineering development, 3D algorithmic development, and extensive tests. In Phase 1, the feasibility of the novel 3D-SFE will be thoroughly investigated. In Phase 2, working closely with clinical experts on our team, we will develop two fully functional 3D-SFE systems. We have streamlined our clinical study plan and focused on using 3D surface imaging capability for minimally invasive surgeries, such as otolaryngology surgeries (access sinus, middle ear, inner ear and skull based surgeries), and eye surgeries and drug placement on optic nerves. Proprietary Information of XIGEN LLC. 0 NIH SBIR PAR-09-220 PUBLIC HEALTH RELEVANCE: Minimally invasive surgeries (MIS) are procedures in which devices are inserted into the body through natural openings or small skin incisions to diagnose and treat/repair a wide range of medical conditions as an alternative to traditional open surgeries. Minimally invasive surgery has achieved pre-eminence for many general surgery procedures over the last two decades and has lead to reduced risk of complications, faster recovery with enhanced patient satisfaction due to reduced postoperative pain and favorable health system economics. Examples of minimally invasive procedures include: otolaryngology surgeries (access sinus, middle ear, inner ear and skull based surgeries), eye surgeries and drug placement on optic nerves, interventional cardiology procedures of balloon angioplasty and stenting; arthroscopic procedures, including knee, shoulder, small joint and hips; and laparoscopic procedures to examine, diagnose and treat problems of the abdomen. However, traditional endoscopes have many shortcomings in performing MIS: 7 Large Diameter of conventional endoscopes (4-13 mm) limits access regions where they can be used; 7 Limited Flexibility of current devices also prevents them from use in confined spaces; 7 Inadequate image quality of conventional endoscopes with small diameter to perform diagnosis or surgical interventions. 7 High Costs of high-resolution fiber bundle endoscopes as well as video-chip endoscopes; 7 Lack of 3D imaging capability, which is especially useful for sizing, diagnosis, registration of pre- operative and intra-operative images, and agile manipulation of instruments in confined spaces when conducting surgeries. Simultaneous 2D and 3D imaging capability would be useful in minimally invasive procedures, which require precise manipulation of multiple instruments. In addition, a method for accurate, real-time registration of endoscopic images with 3D data from CT and MRI images would be a significant advance in endoscopic interventions. Conventional video endoscopes (including the existing SFEs) acquire 2D images without the depth information that is needed for accurate registration with 3D pre-operative data. The ideal solution would be to acquire 3D images directly with the endoscope itself in real-time. 3D images can also enhance the endoscopist's visual feedback for manipulating and positioning the endoscope. Precise and quantitative sizing and 3D measurements are also crucial for surgical interventions. Additionally, the 3D surface from endoscopy optionally registered with CT and/or MR data would provide the endoscopist with better accuracy and more information for making decisions and performing minimally invasive procedures. The primary objective of this SBIR, therefore, is to develop and demonstrate a novel 3D imaging approach, specifically designed for the ultrathin scanning fiber endoscope (SFE) that enables unprecedented simultaneous 2D and 3D surface imaging capability. With pressing needs for effective endoscopic tools for minimally invasive surgeries, and multi-billion dollars spent every year world-wide in the MIS technologies, a practical, ultrathin, and low-cost 3D endoscope with high resolution, larger field of view (FOV), and unprecedented 2D and 3D imaging capability has a great potential for widespread medical and industrial applications.

描述（由申请人提供）：SBIR工作的主要目的是开发具有同时2D/3D表面成像能力的新型超薄（直径为1〜2 mm）扫描纤维内窥镜（SFE）。拟议的3D-SFE将能够首次提供与其2D RGB对应物共同注册的密集的3D XYZ表面数据，这使得3D成像成为SFE成像能力的固有部分，而无需用户执行任何特殊的操作或拍摄多个图像。新颖的3D成像能力将大大提高现有SFE的功能，并使其直径为1〜2 mm的微型探针大小，这是一系列以前无法执行的微创手术程序。 拟议的小说3D-SFE的独特功能是：7个高分辨率全彩2D视频图像； 7前所未有的3D成像能力，具有同时且共同注册的2D和3D图像采集，可能会以视频速率； 7单光纤扫描仪生成立体声3D图像。 7动态可调节的视野和图像分辨率； 7内窥镜的微型尺寸（直径约1毫米）； 7极度灵活性；和7强功能的2D/3D图像处理能力，可用于微创手术。 Xigen LLC根据我们与多个大学和医院的主要研究人员/临床医生的合作以及与领先的研究人员/临床医生的合作，提出了这个全面的SBIR项目。 Xigen团队在生物医学应用中攻击重大而困难的3D成像问题的历史和经验丰富的经验。与华盛顿大学的研究和临床团队紧密合作，这些研究和临床团队已经开发了多个版本的2D扫描光纤内窥镜，我们将为3D-SFE系统开发全尺度设计，算法，硬件，软件和包装，使其成为一种用于微创手术的集成内窥镜图像引导系统，这些系统可以访问许多由于其超薄直径而无法实现现有内窥镜的许多站点。 这种SBIR支持将支持彻底的光学设计，光电机械工程开发，3D算法开发和广泛的测试。在第1阶段，将彻底研究新颖的3D-SFE的可行性。在第二阶段，与团队的临床专家紧密合作，我们将开发两个功能齐全的3D-SFE系统。我们已经简化了临床研究计划，并着重于使用3D表面成像能力进行微创手术，例如耳鼻喉科手术（访问窦，中耳，内耳和基于颅骨的手术），以及眼部手术和眼睛手术和药物对光学神经。 Xigen LLC的专有信息。 0 NIH SBIR PAR-09-220 公共卫生相关性：微创手术（MIS）是通过自然开口或小小的皮肤切口将设备插入体内的程序，以诊断和治疗/修复广泛的医疗状况，以替代传统的开放手术。在过去的二十年中，微创手术在许多一般手术程序中都达到了预先的效果，并导致并发症的风险降低，由于术后疼痛减轻和良好的卫生系统经济学而导致患者的满意度提高，并提高了患者满意度。微创手术的例子包括：耳鼻喉科手术（鼻窦，中耳，内耳和基于颅骨的手术），视神经上的眼科手术和药物放置，气球血管成形术和支架的干预心脏病学程序；关节镜手术，包括膝盖，肩膀，小关节和臀部；以及腹腔镜检查，检查，诊断和治疗腹部问题。 但是，传统的内窥镜在执行错误方面存在许多缺点：7个常规内窥镜（4-13毫米）的大直径限制了可以使用的访问区域； 7当前设备的有限灵活性也使它们无法在狭窄的空间中使用； 7传统内窥镜的图像质量不足，直径较小，无法执行诊断或手术干预措施。 7高分辨率纤维束内窥镜以及视频芯片内窥镜的高成本； 7缺乏3D成像能力，这对于进行手术时的尺寸，诊断，诊断和术中图像的注册以及对工具的敏捷操作特别有用。 同时2D和3D成像能力将在微创过程中有用，这需要精确操纵多种仪器。此外，在内窥镜干预措施中，使用来自CT和MRI图像的3D数据对内窥镜图像进行准确，实时注册的方法将是一个重大进步。传统的视频内窥镜（包括现有的SFE）获取2D图像，而无需使用3D术前数据进行准确注册所需的深度信息。 理想的解决方案是实时使用内窥镜本身直接获取3D图像。 3D图像还可以增强内镜医生的视觉反馈，以操纵和定位内窥镜。精确和定量尺寸和3D测量对于手术干预也至关重要。此外，内窥镜检查中的3D表面和/或MR数据可选注册，将为内镜医生提供更好的准确性和更多信息，以做出决策和执行最低侵入性的程序。 因此，该SBIR的主要目的是开发和演示一种新型的3D成像方法，该方法专为超薄扫描纤维内窥镜（SFE）而设计，该方法可以实现前所未有的同时2D和3D表面成像能力。迫切需要有效的内窥镜工具，用于微创手术，以及每年在全球范围内花费数十亿美元的MIS技术，一种实用，超薄和低成本的3D内窥镜，具有高分辨率，更大的视野（FOV）（FOV） ，并且前所未有的2D和3D成像能力具有广泛的医疗和工业应用的巨大潜力。