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

 描述(申请人提供)：这一阶段的SBIR开发和测试BleedClear系统的可行性，以快速清除凝结的血液，防止有效显示和治疗上消化道(UGI)出血。BleedClear通过内窥镜2.8毫米的工作通道展开，使临床医生能够将内窥镜保持在适当位置，同时安全、快速地将血块从观察区移除。公共卫生问题：急性胃肠道(GI)出血的住院护理每年花费医疗行业25亿美元。在美国，仅上消化道出血每年就导致250,000至300,000人住院，15,000至30,000人死亡。UGI出血一般使用通过内窥镜部署的工具进行微创手术治疗。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，这降低了内窥镜下的可见性，限制了出血部位的诊断和治疗。有未清除的眼底血池、凝结的血块或粘连性血块的患者的发病率和死亡率增加。由于其大小和数量 这些凝块-通常是厘米大小-在试图抽吸它们的过程中通常会堵塞内窥镜，需要在手术过程中多次取出内窥镜并重新插入。使用改进的吸管和冲洗或抓取的工具是存在的，但仍然需要几个小时的操纵来清除血块。当能见度限制内窥镜诊断/治疗时，我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。需要一种用于标准内窥镜的辅助设备，该设备可以通过2.8 mm的工作通道展开，以快速移除大的凝块血块，而不必移除或重新定位内窥镜。第一阶段假设：BleedClear Alpha II原型在UGI模型中部署在2.8 mm工作通道中时，可以快速清除3 cm(直径)x 6 cm的血块，证明了BleedClear在诊断UGI出血的内窥镜检查期间清除大块血块的基本可行性。具体目标：目标1：开发BleedClear Alpha II手持原型，并在UGI模型中演示部署在2.8 mm工作通道中的清除功能。验收标准：BleedClear在解剖UGI模型中通过内窥镜固定在典型弯曲处时，可成功清除血块。来自临床医生(胃肠病专家)的反馈支持总体可行性，并为重点进一步发展提供指导。目标2：确定最佳设备性能的操作参数，以获得最佳的凝块硬度范围。合格标准：BleedClear，操作参数显示有能力在&lt；5分钟20/20试验中完全清除猪血凝块(6厘米x 3厘米)。目的3：通过验证瞬时接触(&lt；3秒)没有刺穿胃壁来证明BleedClear的安全性。验收标准：BleedClear原型在模拟使用中接触猪胃壁，在20/20次试验中没有穿孔。

 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.