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

用于内窥镜尖端稳定以及锯齿状无蒂息肉的完整可视化和解剖的主动一次性帽

• 批准号: 10438928
• 负责人: Maureen L. Mulvihill
• 金额: $ 30.54万
• 依托单位: ACTUATED MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-07 至 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10438928
• 关键词: Adoption; Adult; Anatomy; Biological Models; Businesses; Caliber; Cancer Etiology; Cauterize; Cessation of life; Childhood; Colon; Colonic Polyps; Colonoscopy; Colorectal Cancer; Complex; Development; Devices; Diagnosis; Dissection; Distal; Economic Models; Effectiveness; Electrocoagulation; Endoscopes; Endoscopy; Equipment; Evaluation; Excision; Family; Family suidae; Fingers; Frequencies; Goals; Gold; Hand; Health Care Costs; Healthcare Systems; Hospitals; Human; Industrialization; Investments; Japanese; Legal patent; Length; Lesion; Letters; Licensing; Malignant - descriptor; Malignant Neoplasms; Manufacturer Name; Marketing; Medical; Medical Device; Medical center; Methods; Modeling; Motion; Outcome; Patient Care; Perforation; Physicians; Pilot Projects; Polypectomy; Polyps; Price; Procedures; Production; Public Health; Readiness; Recurrence; Regimen; Research Design; Residual state; Risk; Safety; Sales; Schedule; Sessile Lesion; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Sterilization; System; Techniques; Technology; Testing; Time; Tissues; Traction; Update; Validation; Visualization; base; biomaterial compatibility; cancer diagnosis; care costs; colorectal cancer prevention; colorectal cancer screening; commercialization; cost; design; ergonomics; flexibility; grasp; health economics; improved; innovation; operation; patient safety; preclinical study; programs; response; safety outcomes; scale up; screening; tool; tumor; usability; validation studies; verification and validation

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).

该 SBIR CRP 项目开展活动以增加医院使用、采用和销售“Active 一次性内窥镜系统帽 (ACE)。ACE 是压在内窥镜远端的帽， 带有连接到近端控制装置的集成手指。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。其设计使医生能够 保持程序的人体工程学。项目目标是：1）优化材料和工业生产 降低总体成本的方法，2) 生成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) 提交的设备等效性。此外，项目团队将开发一个 投资者一揽子计划，以及医院参与和价值分析委员会战略，以及商业专家。 公共卫生问题：在美国，结直肠癌是最致命和最昂贵的癌症之一。 目前的内窥镜工具不足以始终如一地完全切除结肠息肉。大（>2厘米）， 复杂的息肉（例如扁平无蒂病变）特别容易复发和恶变，影响 患者护理和医疗保健费用。标准分段切除术的复发率显着 与残留息肉和恶性病变重新种植的风险相关，<2 cm 息肉的风险从 3% 增加 对于 >2 厘米的息肉，高达 85%。在一项日本研究中，内镜粘膜下剥离术 (ESD) 能够整体实现 84-95% 的病例切除了 >2 cm 息肉，肿瘤复发率低至 0-2%。在 在美国，结肠整体 ESD 的使用频率远低于 50%。 ESD 程序可能需要 100 多次 分钟相比，更常见的分段切除需要 20-50 分钟，有助于 该程序的使用有限。可用于在 ESD 中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 能够在更广泛的范围内快速执行安全有效的整体 ESD 并完全切除病灶 设施。，目标是提供 ESD 设备，以增加该技术在美国的使用和采用， 提高疗效、患者安全和结果，同时降低成本。 假设：通过适应成人解剖结构的广度，优化生产和扩大规模 和技术援助，AMI 生产 4 个型号的 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（第 1-7 部分） 目标 2. 减少材料清单和装配成本（Mos. 6-9） 目标 3. 验证和确认 (V&V) 以及等效性临床前研究 (Mos. 7-18) 目标 4. 业务开发和价值主张验证（Mos. 1-18）。