ACTUATED MEDICAL, INC. — Department of Health and Human Services SBIR Phase I: 300

Description

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 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 $ billion per year Upper GI bleeds alone result in to hospitalizations and to 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 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 cm diameter x cm blood clots while deployed in mm working channel in UGI model demonstrating basic feasibility of BleedClear for large clot clearance during diagnostic endoscopy for UGI bleed Specific Aims Aim Develop BleedClear Alpha II handheld prototype and demonstrate clearing functionality while deployed in mm 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 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 cm x cm in size in andlt minutes trials Aim Demonstrate safety of BleedClear by verifying momentary contact andlt sec does not puncture gastric wall Acceptance Criteria BleedClear prototype contacting porcine gastric wall in simulated use results in no perforations in trials PUBLIC HEALTH RELEVANCE Relevance Inpatient care for acute gastrointestinal GI bleeding costs the healthcare industry $ billion per year Upper GI bleeds results in to hospitalizations and to deaths per year in the US annually GI bleeds are generally treated with minimally invasive surgery using tools deployed through an endoscope Masses of clotted blood in the stomach can increase complication rates by due to lack of options to clear clots from the field of view with current devices An accessory device for standard endoscopes is needed that can be deployed through the mm working channel to quickly remove large clotted blood masses without having to remove or reposition the scope