A Double Balloon Catheter for the Treatment of Intussusception in Children

Sealcath, Llc, Mount Pleasant SC

Investigators

Abstract

PROJECT SUMMARY/ABSTRACT During Phase I, SealCath, LLC will test the feasibility of its innovative Double Balloon Catheter (DBC), which the United States Utility Patent application was approved on August 31, 2017 and is in the process of issuing a patent. Licensed from the Medical University of South Carolina, this DBC will be commercialized in Phase III as the trademarked name ?Cephus Catheter? with targeted end users being pediatric radiologists, radiologists, pediatricians, pediatric gastroenterologists, and pediatric surgeons. The 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-consuming, often painful, and detrimental to patient outcomes. This work- around approach for existing catheters is not only wasteful in terms of time and various costs, it also exposes both patients and clinical staff to higher dosages of radiation in undergoing and performing intussusception reductions. While the proposed project and R&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 procedures (e.g., intussusception reduction) to treat intussusception, its utility will encompass any bowel-related problem using procedures, which require an airtight seal, such as meconium plug syndrome, colonic wash-outs for constipation, mucus fistula/sinus tract evaluations, and congenital imperforate anus or anorectal malformation interventions. Consequently, the proposed innovation has the potential to widely improve the delivery of various medical procedures among international pediatric populations with bowel- related problems. Scientifically, there is a void in the research literature to inform progress towards innovating an airtight catheter solution such as the proposed innovation. The Phase I project will advance knowledge in the radiology field by producing a unique data set and research findings, which may generate exploratory research by other scientists as well. Phase I project methodology will employ benchtop testing of the Cephus Catheter prototype followed by in vivo and ex vivo testing to finalize the design, establish the safety, and validate the feasibility of the innovation. The Phase I specific aims are: 1) To perform quality and safety benchtop testing on 300 prototypes of the Cephus Catheter, 2) To conduct in vivo laboratory testing of the Cephus Catheter utilizing six 6 weeks to 4 months-old Yorkshire swine weighing between 5-15 kg, 3) To conduct ex vivo laboratory testing of the Cephus Catheter utilizing 20 explanted porcine tissue from pigs entering the USDA food chain harvested with the rectal musculature intact.