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（由申请人提供）：这一I阶段SBIR开发并测试了Bleedclear系统的可行性，以快速清除凝结的帽子，可防止胃肠道（UGI）的有效治疗。从急性胃肠道（GI）出现的NAPERTAINT CARE，占用了250,000至300,000的住院费用。通过内窥镜部署的工具，临床医生面对的是血液和凝块的存在，可降低内窥镜的可见性，并限制了由于大小和死亡率而增加的诊断和治疗。数量 凝块通常在吸气过程中，需要在过程中多次插入，以改进的刺激和灌溉或抓地力。重复内窥镜检查，干预性手术或促进支架的辅助装置。在UGI内窥镜检查过程中，在UGI模型的2.8毫米工作渠道中部署了特定的目标：AIM 1：开发BleedClear Alpha II手持原型，并在UGI模型中表现出清除功能的工作通道。模型提供了进一步的开发目标2：在<5分钟20/20的试验中，确定凝块牢固的操作参数（6cm x 3cm）。接触（<3秒）不穿刺胃壁。