BleedClear System: Rapid and Safe Removal of Coagulated Blood, Uncleared Fundal Pools, and Adherent Clots from the Stomach Through a 2.8 mm Endoscope Channel to Improve Efficacy in UGI Bleed Treatment

BleedClear 系统：通过 2.8 毫米内窥镜通道快速安全地清除胃中的凝固血液、未清除的胃底池和粘附凝块，以提高上消化道出血治疗的效果

• 批准号: 8980245
• 负责人: Roger Brooks Bagwell
• 金额: $ 22.5万
• 依托单位: ACTUATED MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-01 至 2016-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8980245
• 关键词: Acute; Acute upper gastrointestinal hemorrhage; Anatomy; Area; Aspirate substance; Automobile Driving; Award; Blood; Blood coagulation; Blood specimen; Caliber; Caring; Cessation of life; Clinical Research; Coagulation Process; Complication; Cyclic GMP; Data; Development; Devices; Diagnosis; Diagnostic; Endoscopes; Endoscopy; Enteral Feeding; Excision; Face; Family suidae; Feedback; Gastric Lavage; Gastroenterologist; Gastrointestinal tract structure; Goals; Healthcare Industry; Hemorrhage; Hospitalization; Hospitals; Hour; Human body; Imagery; Inpatients; Interventional radiology; Irrigation; Knowledge; Lead; Length of Stay; Location; Manufacturer Name; Marketing; Medical; Medical Device; Modeling; Morbidity - disease rate; Motion; Operative Surgical Procedures; Outcome; Patients; Perforation; Performance; Phase; Procedures; Public Health; Puncture procedure; Resources; Risk; Rodent; Safety; Sales; Site; Small Business Innovation Research Grant; Stomach; Suction; System; Technology; Testing; Time; Treatment Cost; United States National Institutes of Health; Work; commercialization; cost; design; effective therapy; gastrointestinal; high risk; improved; innovation; manufacturing scale-up; minimally invasive; mortality; prevent; prototype; public health relevance; stem; success; tool; verification and validation

 DESCRIPTION (provided by applicant): This Phase I SBIR develops and tests feasibility of the BleedClear system to quickly clear coagulated blood that prevents effective visualization and treatment of upper gastrointestinal (UGI) bleeds. BleedClear is deployed through the 2.8 mm working channel of an endoscope, allowing the clinician to keep the endoscope in place while safely and quickly removing blood masses from the viewing area. Public Health Problem: Inpatient care for acute gastrointestinal (GI) bleeding costs the healthcare industry $2.5 billion per year. Upper GI bleeds alone result in 250,000 to 300,000 hospitalizations and 15,000 to 30,000 deaths per year in the US. UGI bleeds are generally treated with minimally invasive surgery using tools deployed through an endoscope. A well-known problem clinicians face is the presence of blood and clots that reduce endoscopic visibility and limit diagnosis and treatment of the bleeding site. Patients with uncleared fundal pools of blood, coagulated blood masses, or adherent clots suffer an increased risk of morbidity and mortality. Due to the size and quantity of the clots - often centimeters in scale - they typically clog the endoscope during attempts to aspirate them, requiring the scope to be pulled out and re-inserted multiple times in the course of a procedure. Tools employing improved suction and irrigation or graspers exist, but can still take hours of manipulation to clear clots. When visibility limits endoscopic diagnosis/treatment, i can impact length of stay, number of units of blood transfused, and lead to repeat endoscopy, interventional radiology procedures, or emergent surgery and thus straining hospital resources and driving up treatment costs. An accessory device for standard endoscopes is needed that can be deployed through the 2.8 mm working channel to quickly remove large clotted blood masses without having to remove or reposition the scope. Phase I Hypothesis: BleedClear Alpha II prototype quickly clears 3cm (diameter) x 6cm blood clots while deployed in 2.8mm working channel in UGI model, demonstrating basic feasibility of BleedClear for large clot clearance during diagnostic endoscopy for UGI bleed. Specific Aims: Aim 1: Develop BleedClear Alpha II handheld prototype and demonstrate clearing functionality while deployed in 2.8mm working channel in UGI model. Acceptance Criteria: BleedClear is successful in clearing clots when deployed through endoscope held in typical curvatures in anatomic UGI model. Feedback from clinicians (Gastroenterologists) supports overall feasibility and provide guidance to focus further development. Aim 2: Determine operating parameters for best device performance for ranging clot firmness. Acceptance Criteria: BleedClear with operating parameters demonstrating ability to completely clear porcine blood clots (6cm x 3cm in size) in <5 minutes 20/20 trials. Aim 3: Demonstrate safety of BleedClear by verifying momentary contact (<3 sec) does not puncture gastric wall. Acceptance Criteria: BleedClear prototype contacting porcine gastric wall in simulated use results in no perforations in 20/20 trials.

 描述（由申请方提供）：本I期SBIR开发并测试了BleedClear系统快速清除阻止有效可视化和治疗上消化道（UGI）出血的凝血的可行性。BleedClear通过内窥镜的2.8 mm工作通道展开，使临床医生能够将内窥镜保持在原位，同时安全快速地从观察区域清除血块。公共卫生问题：急性胃肠道（GI）出血的住院治疗每年花费医疗保健行业25亿美元。在美国，仅上消化道出血每年就导致250，000至300，000例住院治疗和15，000至30，000例死亡。上消化道出血通常采用微创手术治疗，使用通过内窥镜部署的工具。临床医生面临的一个众所周知的问题是血液和凝块的存在，这降低了内窥镜的可见性，并限制了出血部位的诊断和治疗。患有未清除的眼底血池、凝固的血块或粘附的血块的患者的发病率和死亡率风险增加。由于其规模和数量 这些凝块通常是厘米级的，它们通常在试图抽吸它们的过程中阻塞内窥镜，需要在手术过程中多次将内窥镜拉出和重新插入。存在采用改进的抽吸和冲洗或抓钳的工具，但仍可能需要数小时的操作来清除凝块。当可见性限制内窥镜诊断/治疗时，可能会影响住院时间、输血单位数，并导致重复内窥镜检查、介入放射学程序或紧急手术，从而使医院资源紧张并推高治疗成本。标准内窥镜需要一种辅助器械，可通过2.8 mm工作通道展开，以快速清除大的凝血团块，而无需取出或重新定位内窥镜。第一阶段假设：BleedClear Alpha II原型在UGI模型的2.8mm工作通道中展开时可快速清除3cm（直径）x 6cm的血凝块，证明了BleedClear在诊断性内镜检查UGI出血期间清除大凝块的基本可行性。具体目标：目标1：开发BleedClear Alpha II手持式原型，并在UGI模型中的2.8 mm工作通道中部署时演示清除功能。验收标准：当通过在解剖UGI模型中保持典型曲率的内窥镜展开时，BleedClear可成功清除凝块。临床医生（胃肠病学家）的反馈支持总体可行性，并为进一步开发提供指导。目的2：确定操作参数，以获得最佳器械性能，从而确定凝块硬度范围。验收标准：BleedClear的操作参数证明了在<5分钟20/20试验中完全清除猪血凝块（尺寸为6cm x 3cm）的能力。目的3：通过验证瞬时接触（<3秒）不会刺穿胃壁来证明BleedClear的安全性。验收标准：在模拟使用中接触猪胃壁的BleedClear原型在20/20次试验中没有穿孔。