Bioptigen SBIR Phase I resubmittal: Pediatric OCT

Bioptigen SBIR I 期重新提交：儿科 OCT

• 批准号: 7669804
• 负责人: Bradley A. Bower
• 金额: $ 15.08万
• 依托单位: BIOPTIGEN, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-05-01 至 2010-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7669804
• 关键词: 3-Dimensional; Adult; Animals; Anterior; Arts; Businesses; Childhood; Clinical; Communities; Computer software; Development; Devices; Diagnostic; Disease Progression; Early Diagnosis; Elderly; Engineering; Exhibits; Eye; Eye Movements; Fundus; Hand; Housing; Human; Human Volunteers; Image; Imagery; Infant; Interferometry; Iris; Length; Life; Location; Manuals; Marketing; Mechanics; Modeling; Neonatal; Operative Surgical Procedures; Optical Coherence Tomography; Optics; Pathology; Patients; Performance; Phase; Principal Investigator; Research; Research Ethics Committees; Resolution; Retinal; Sampling; Scanning; Small Business Innovation Research Grant; Speed; System; Technology; Testing; Time; Tissues; Training; Universities; Upper arm; Weight; base; design; improved; innovation; instrumentation; new technology; patient population; phantom model; programs; prototype; public health relevance; tool

DESCRIPTION (provided by applicant): This Phase I Small Business Innovative Research application proposes to introduce for the first time to commercial availability a spectral domain optical coherence tomography (SDOCT) system specifically designed for pediatric patients. OCT is a well-established technology for ophthalmic imaging, using low-coherence interferometry to non-invasively obtain cross-sectional images in living tissues with micron-scale resolution.. Bioptigen, Inc., a startup company affiliated with Duke University, has developed a state- of-the-art retinal SDOCT system using chinrest-mounted delivery optics under prior SBIR Phase I/II support, and has brought this slit-lamp based system to market. Bioptigen has also prototyped rudimentary handheld probes for use with immobile human patients and animal subjects. There has been significant pull from the user community for improvements to these handheld probes for pediatric and infant/neonatal applications, particularly for improvements in alignment and focus. Bioptigen proposes to develop new technology for a practical handheld SDOCT interface and associated system functionality which will make the considerable benefits of ophthalmic SDOCT imaging available to pediatric and infant/neonatal patient populations for the first time. The specific aims of the proposal are as follows: Specific Aim 1: Develop and prototype a handheld SDOCT device for pediatric imaging, to include: a) High-speed OCT scanning optics (with expanded FOV and EasyDriveTM (akin to an `iris camera') performance for ease of use, suitable for 2 and 3-D retinal imaging, b) Calibrated manual twist focus control capable of +20 Diopter adjustment, c) All of the above in a size and weight suitable for hand-held operation. Specific Aim 2: Develop and prototype a design for a pediatric SDOCT system, to include: a) Design of the housing for the handheld probe to incorporate the new optical design b) Electro-mechanical control of the reference arm delay to match subject eye length, c) Construct a fully functioning engineering prototype incorporating these features. Specific Aim 3: To integrate and test the optical and electromechanical designs, including: a) Develop firmware and software control for the hardware improvements, b) Develop an OCT-specific adjustable eye model for testing and training, c) Test image quality on eye models and phantoms, and (under the aegis of Dr. Freedman's IRB) on adult human volunteers. PUBLIC HEALTH RELEVANCE: Spectral Domain Optical Coherence Tomography (SDOCT) dramatically improves the visualization of retinal pathologies through the real-time acquisition of densely sampled high resolution volumetric images. The pediatric patient population is not served by current OCT instrumentation. Other than Retcam", a handheld fundus camera, there are simply no diagnostic tools available today to support early diagnosis and prediction of pediatric ophthalmic disease progression. Bioptigen recognizes the need for a handheld SDOCT imaging system with variable eye-length adjustment and focus, and unsurpassed ease of use. In this project, we propose to develop a hand held multi-function SDOCT imaging system, offering high speed, high resolution contact and non-contact SDOCT imaging, new optics to improve field of view, alignment and registration, and automated control of reference arms length to match axial length in a wide range of pediatric and other patient groups. This development follows directly from successful implementation in an adult system, and will offer superior quality SDOCT imaging to the underserved pediatric clinical community. Bioptigen confidential

描述（由申请人提供）：本I期小型企业创新研究申请计划首次将专门为儿科患者设计的光谱域光学相干断层扫描（SDOCT）系统引入商业应用。OCT是一种成熟的眼科成像技术，使用低相干干涉法以微米级分辨率无创地获得活组织中的横截面图像。Bioptigen，Inc.，一家附属于杜克大学的创业公司已经开发了一种在现有SBIR阶段I/II支持下使用安装在颚托上的传输光学器件的最先进的视网膜SDOCT系统，并且已经将这种基于裂隙灯的系统推向市场。Bioptigen还开发了基本的手持探头原型，用于固定的人类患者和动物受试者。用户群体强烈要求改进这些用于儿科和婴儿/新生儿应用的手持式探头，特别是改进对准和聚焦。Bioptigen建议开发实用手持式SDOCT接口和相关系统功能的新技术，这将首次使儿科和婴儿/新生儿患者群体获得眼科SDOCT成像的巨大益处。该提案的具体目标如下：具体目标1：开发用于儿科成像的手持式SDOCT设备并制作原型，包括：a）高速OCT扫描光学器件（具有扩展的FOV和EasyDriveTM（类似于“虹膜照相机”）性能，易于使用，适用于2-D和3-D视网膜成像，B）校准的手动扭曲聚焦控制，能够进行+20屈光度调节，c）所有上述设备的尺寸和重量均适合于手持式操作。具体目标二：开发儿科SDOCT系统的设计并制作原型，包括：a）手持式探头的外壳设计，以纳入新的光学设计B）参考臂延迟的机电控制，以匹配受试者眼睛的长度，c）构建一个功能齐全的工程原型，纳入这些功能。具体目标3：集成和测试光学和机电设计，包括：a）开发硬件改进的固件和软件控制，B）开发OCT专用可调节眼模型用于测试和培训，c）在眼模型和体模上以及（在Freedman博士IRB的支持下）在成人志愿者上测试图像质量。公共卫生关系：谱域光学相干断层扫描（SDOCT）通过实时采集密集采样的高分辨率体积图像，显著改善了视网膜病变的可视化。当前OCT仪器不适用于儿科患者人群。除了Retcam”，一种手持式眼底照相机，今天根本没有可用的诊断工具来支持儿科眼科疾病进展的早期诊断和预测。Bioptigen认识到需要一个手持SDOCT成像系统，具有可变的眼睛长度调节和焦点，以及无与伦比的易用性。在本项目中，我们建议开发一种手持式多功能SDOCT成像系统，提供高速、高分辨率接触式和非接触式SDOCT成像，新的光学器件，以改善视野、对准和配准，以及自动控制参考臂长度，以匹配广泛的儿科和其他患者群体的轴向长度。这一发展直接来自于成人系统的成功实施，并将为服务不足的儿科临床社区提供上级质量的SDOCT成像。Bioptigen机密