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，以增加医院访问、采用和销售Active 用于内窥镜系统(ACE)的一次性盖。ACE是压在内窥镜远端的盖子， 集成的手指连接到近端控制装置。它允许临床医生在复杂的过程中操纵组织 在不占用内窥镜工作通道的情况下进行息肉切除术。它的设计使医生能够 维护程序的人体工程学。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)提交的设备等价性。此外，项目团队将制定一项 投资者方案，以及医院参与和价值分析委员会战略，与商业专家一起。 公共卫生问题：在美国，结直肠癌是最致命、最昂贵的癌症之一。 目前的内窥镜检查工具不足以始终如一地完全切除结肠息肉。大(&gt；2厘米)， 复杂性息肉(如扁平无梗病变)特别容易复发和恶变，影响 病人护理和医疗保健成本。标准分段切除的复发率，显著 与残留息肉相关，如果是恶性的，则有再次种植病变的风险，高于2厘米息肉的3% 至85%的息肉&>2厘米。在日本的一项研究中，内窥镜黏膜下剥离术(ESD)实现了整块 84-95%的病例切除2厘米息肉，肿瘤复发率为0-2%。在 在美国，整体ESD在结肠中的使用频率远低于50%。ESD程序可以占用100多个 相比之下，更常见的零碎切除需要20-50分钟，这有助于 该程序的使用受到限制。在ESD中可用于辅助牵引和反牵引的少数系统包括 价格昂贵、复杂，只能安装有限数量的内窥镜，单手使用也很困难。王牌会 在更广泛的范围内实现安全、有效的整体ESD和完全病变清除 设施。目标是提供一种ESD设备，以增加该技术在美国的访问和采用， 在降低成本的同时提高疗效、患者安全性和预后。 假设：通过适应成人人体解剖的广度，优化生产和扩大规模 和技术支持，AMI为ESD生产一次性内窥镜配件的4种型号系列， 提高市场准入、采用率和销售量。 目的1.ACE型号扩展了电子外科和内窥镜设备的兼容性(MOS)。1-7) 目标2.降低物料清单和装配成本(MOS6-9) 目的3.验证和确认(V&V)和临床前等效性研究(MOS)。7-18) 目标4.业务开发和价值主张验证(MOS1-18)。

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).