Active Disposable Cap for Endoscope Tip Stabilization and Complete Visualization and Dissection of Serrated Sessile Polyps

该SBIR CRP项目开展活动，以增加医院的访问，采用和销售的'主动 内窥镜系统用一次性帽（ACE）。ACE是压在内窥镜远端上的帽， 其具有连接到近端控制器的集成指状物。它允许临床医生在复杂的手术过程中操纵组织， 息肉切除术而不占用内窥镜的工作通道。其设计使医生能够 保持程序的人体工程学。该项目的目标是：1）优化材料和工业生产 降低总体成本的方法，2）生产与大多数内窥镜集成的优化模型 用于不同人体解剖结构的尺寸，以及3）进行验证和确认以及临床前研究 旨在确认510（k）申报的器械等同性。此外，项目团队将开发一个 投资者包，医院参与和价值分析委员会战略，与业务专家。 公共卫生问题：在美国，结肠直肠癌是最致命和最昂贵的癌症形式之一。 目前的内窥镜检查工具不足以持续地完全切除结肠息肉。大（>2 cm）， 复杂的息肉（例如，扁平无蒂病变）特别容易复发和恶性， 患者护理和医疗保健费用。标准分段切除术的复发率显著高于标准分段切除术， 与残留息肉相关，如果是恶性的，则有重新种植病变的风险，从<2 cm息肉的3%增加 息肉> 2cm者为85%。在日本的一项研究中，内镜粘膜下剥离术（ESD） 在84-95%的病例中切除了> 2cm的息肉，并且显示出低的0-2%的肿瘤复发率。在 美国，在结肠中整体ESD的使用远低于50%的频率。ESD程序可能需要100多个 与更常见的碎片切除术的20-50分钟相比， 程序的有限使用。在ESD中，可用于辅助牵引和反牵引的少数系统是 昂贵、复杂、仅适合有限数量的内窥镜，并且难以单手使用。ACE将 能够在更大范围内快速进行安全有效的整体ESD和完全切除病变， 设施。，目标是提供一种ESD器件以增加该技术在美国的使用和采用， 提高疗效、患者安全性和结果，同时降低成本。 假设：通过适应成人解剖学的广度，优化生产和扩大规模 和技术援助，AMI生产了4种型号的ESD一次性内窥镜配件系列， 实现更大的市场准入、采用和销售。 目标1. ACE型号扩展了电外科和内窥镜设备的兼容性（Mos.（第1-7段） 目标二。降低物料清单和装配成本（Mos.（第6至9段） 目标3。验证与确认（V&V）和临床前等效性研究（Mos.（第7至18段） 目标4。业务发展和价值主张验证（Mos。1-18）。

This SBIR CRP project conducts activities to increase hospital access, adoption, and sales of the ‘Active Disposable Cap for Endoscope system (ACE).’ ACE is a cap pressed onto the distal end of the endoscope, with integrated fingers connected to proximal controls. It allows a clinician to manipulate tissue during complex polypectomies without occupying the endoscope’s working channel. Its design enables the physician to maintain procedure ergonomics. The project goals are to: 1) optimize materials and industrial production methods to reduce overall costs, 2) produce optimized models that integrate with the majority of endoscope sizes used with differing human anatomies, and 3) conduct Verification and Validation and preclinical studies designed to confirm device equivalence for 510(k) submission. Additionally, the project team will develop an investor package, and a hospital engagement and Value Analysis Committee strategy, with business experts. Public Health Problem: In the U.S., colorectal cancer is one of the most deadly and costly forms of cancer. Current endoscopy tools are inadequate to consistently enable full resection of colon polyps. Large (>2 cm), complicated polyps (e.g., flat sessile lesions) are particularly prone to recurrence and malignancy, impacting patient care and healthcare costs. Recurrence rates of standard piecemeal resection, which are significantly associated with residual polyp and risk of reseeding of lesions if malignant, increase from 3% for <2 cm polyps to 85% for polyps >2 cm. In one Japanese study, endoscopic submucosal dissection (ESD) enabled en bloc removal of >2 cm polyps in 84-95% of cases, and demonstrated a low 0-2% tumor recurrence rate. In the U.S., the use of en bloc ESD in the colon is well below 50% frequency. ESD procedures can take over 100 minutes compared to 20-50 minutes for more commonly performed piecemeal resections, contributing to limited use of the procedure. The few systems that are available to aid traction and countertraction in ESD are expensive, complex, only fit a limited number of endoscopes, and are difficult to use one-handed. ACE will enable safe and effective en bloc ESD with full lesion removal to be performed rapidly at a wider range of facilities., the goal is to provide an ESD device to increase access and adoption of the technique in the U.S., improving efficacy, patient safety and outcomes while reducing cost. Hypothesis: By accommodating the breadth of adult human anatomies, optimization of production and scale-up and technical assistance, AMI produces a 4-model family of disposable endoscopic accessories for ESD that enable greater market access, adoption, and sales. Aim 1. ACE Models Expand Electrosurgical and Endoscope Equipment Compatibility (Mos. 1-7) Aim 2. Reduce Bill of Materials and Assembly Costs (Mos. 6-9) Aim 3. Verification and Validation (V&V) and Preclinical Study for Equivalence (Mos. 7-18) Aim 4. Business Development and Value Proposition Validation (Mos. 1-18).