Development of Self-Expanding Foams for Percutaneous Damage Control of Retroperitoneal Pelvic Exsanguination

DESCRIPTIONprovided by applicantSignificanceTraumatic pelvic bleeding is a significant cause of morbidity and mortalityand many patients die from potentially survivable injuriesThese injuries claim up tolives every year in the United StatesThis fact highlights an emergent need for innovative technologies to control bleeding in the most severely injured patientsApproachThis FastTrack SBIR application will develop novelself expanding polyurethane foam systems for treatment of exsanguinating pelvic hemorrhageIn Phase I of the proposalArsenal Medical will collaborate with Massachusetts General HospitalMGHto create a novelclinically relevant animal model of pelvic hemorrhageA trimodal approach incorporating vascular injurysoft tissue injuryand tissue disruption will be utilizedTo estabish baseline performance and areas for optimizationexisting treatments will be testedincluding Arsenal Medical s ResQFoam technologydesigned for intraabdominal useIn Phase II of the proposala foam will be developed for efficacy and removal in the pelvic space by modulating open cell microstructure and improving foam mechanical propertiestensile strengthelasticityof the polyurethane strutsThe appropriate dose of this self expanding foam for effectiveness in pelvic bleeding will be determined through a dose ranging studyThe net result will be an effective biomaterial intervention for treatment of pelvic bleedingAfter optimizing the foama comprehensive physiological study of ischemia reperfusion dynamics will be conductedPhase II will culminate in the preparation of a preliminary regulatory submission to the FDAInnovationThe trauma community lacks a robust animal model for the assessment of therapeuticssurgical approachesand devices for the treatment of pelvic hemorrhageEstablishing this animal modelas well as critical research in ischemia reperfusion injurieswill provide substantial benefit to the trauma communitySelf expanding foam treatment will be effectively developed for clinical use in retroperitoneal pelvic bleeding based on the aims of this proposalresulting i a new life saving therapyAn establishedproductive interdisciplinary teamestablished regulatory pathwayand existing manufacturing infrastructure increase the probability of success and commercialization of self expanding foams for pelvic traumaThe proposed research will develop the first closed cavitylethal model of pelvic exsanguination and create a minimally invasive foam platform for pelvic hemostasis that will be superior to the existing standard of care