SEALCATH LLC — Department of Health and Human Services SBIR Phase I: NICHD

Description

PROJECT SUMMARY ABSTRACT During Phase ISealCathLLC will test the feasibility of its innovative Double Balloon CatheterDBCwhich the United States Utility Patent application was approved on Augustand is in the process of issuing a patentLicensed from the Medical University of South Carolinathis DBC will be commercialized in Phase III as the trademarked nameCephus Catheterwith targeted end users being pediatric radiologistsradiologistspediatricianspediatric gastroenterologistsand pediatric surgeonsThe proposed project seeks to shift current clinical practice for pediatric intussusception reduction by eliminating the need for catheter work arounds due to anorectal air leakage that are time consumingoften painfuland detrimental to patient outcomesThis workaround approach for existing catheters is not only wasteful in terms of time and various costsit also exposes both patients and clinical staff to higher dosages of radiation in undergoing and performing intussusception reductionsWhile the proposed project and Randamp D to be conducted within Phases I and II will focus on the technical and commercial feasibility effectiveness of utilizing the Cephus Catheter with pediatric populations in non surgical procedurese gintussusception reductionto treat intussusceptionits utility will encompass any bowel related problem using procedureswhich require an airtight sealsuch as meconium plug syndromecolonic wash outs for constipationmucus fistula sinus tract evaluationsand congenital imperforate anus or anorectal malformation interventionsConsequentlythe proposed innovation has the potential to widely improve the delivery of various medical procedures among international pediatric populations with bowelrelated problemsScientificallythere is a void in the research literature to inform progress towards innovating an airtight catheter solution such as the proposed innovationThe Phase I project will advance knowledge in the radiology field by producing a unique data set and research findingswhich may generate exploratory research by other scientists as wellPhase I project methodology will employ benchtop testing of the Cephus Catheter prototype followed by in vivo and ex vivo testing to finalize the designestablish the safetyand validate the feasibility of the innovationThe Phase I specific aims areTo perform quality and safety benchtop testing onprototypes of the Cephus CatheterTo conduct in vivo laboratory testing of the Cephus Catheter utilizing sixweeks tomonths old Yorkshire swine weighing betweenkgTo conduct ex vivo laboratory testing of the Cephus Catheter utilizingexplanted porcine tissue from pigs entering the USDA food chain harvested with the rectal musculature intact PROJECT NARRATIVE Intussusception is the most common cause of intestinal obstruction for infants children and occurs when the bowel telescopes into itselfThe Cephus Catheter will make the non surgical procedurecalled intussusception reductionto remedy this problem less painful for the infants children undergoing itIn additionit will decrease the amount of the radiation dose during the procedure for infants children and those treating themwhile also making it less likely that surgery will be needed due to the procedure failing