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

基本信息

批准号：
10324810
负责人：
Maureen L. Mulvihill
金额：
$ 69.45万
依托单位：
ACTUATED MEDICAL, INC.
依托单位国家：
美国
项目类别：
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/10324810
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 Population 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

项目摘要

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，集成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。其设计使医生能够在不占用内窥镜工作通道的情况下进行息肉切除术。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一致地完全切除大（> 2 cm）的结肠息肉。复杂的息肉（例如扁平无蒂病变）特别容易复发和恶变，影响标准分段切除术的复发率非常高。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% 增加在一项日本研究中，内镜粘膜下剥离术 (ESD) 可以整体治疗息肉 >2 厘米。 84-95% 的病例切除了 >2 cm 息肉，肿瘤复发率低至 0-2%。在美国，结肠整体 ESD 的使用频率远低于 50%，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，可用于辅助 ESD 牵引和反牵引的系统如下。昂贵、复杂、仅适合有限数量的内窥镜，并且难以单手使用 ACE。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）。