N8 MEDICAL INC — Department of Health and Human Services STTR Phase I: NHLBI

Description

ABSTRACT Infection is a serious and potentially fatal complication of surgery to deliver cardiovascular implantable electronic devicesCIEDsi epacemakers and implantable cardioverter defibrillatorsUntreated device related infection is associated with mortality rates as high asCurrentlyonly one antibiotic impregnated mesh has been FDA approved for placement in surgical incisions to reduce infections associated with the implantation of CIEDsHoweverstaphylococci bacteriawhich are commonly found in CIED infectionshave well documented resistance to the combination antibiotics used in the meshMoreoverthe antibacterials can promote the growth of fungiia source of rarebut highly fatal CIED infectionsThe use of the currentbulky implantable mesh envelops increase surgical pocket sizewhich can restrict a patientandapos s physical activities and increase the chance of infectionAnd the meshitselfcontributes to the space constraints of the surgical pocketwhich reduces the size of the CEIDs that can be accommodatedyet the vast majority of patients would prefer larger devices that last longerIncreasing the length of time between device retrievals and reimplantations would improve the quality of life for patients while decreasing the risk of infections associated with surgeryThe objective of this Phase I SBIR proposal is to useD printing to fabricate a biodegradable polycaprolactonePCLbased antimicrobial envelopeto be fitted outside of cardiac rhythm deviceswhich will prevent infections after surgical implantationThe hypothesis is that a slow degradationhydrolysisof the PCL envelope will gradually release a novel antimicrobial compoundCSAa cerageninfor antimicrobial and anti fungal activityCSAis a synthetic non peptide compoundwith no pre existing pool of resistancethat mimics the activity of the bodyandapos s endogenous antimicrobial peptidesThe proposed device will be the first to prevent fungal colonization of cardiac deviceswhile still providing superior and longer lasting inhibition of bacterial growthMoreoverthe customization allowed byD printing will also minimize surgical pocket space constraintsTo advance this antibiotic mesh technologya PCL filament forD printing applications will be developed that is loaded with the antimicrobialCSAThe elution profiles of the filament will be evaluated and the in vitro efficacy of CSAwill be testedNextenvelopes composed of antibiotic loaded filament will be fabricatedD printingfollowing a design that accommodates a pacemakerAndfinallythe antimicrobial and anti fungal properties of the PCL envelope will be demonstrated and its cytotoxicity evaluatedIt is expected that incorporation of CSAinto aD printed biodegradable mesh will either prevent or significantly reduce biofilm formation on CIEDs when exposed to daily inocula of Staphylococcus aureusMRSAfor at leastdaysThis project will pioneer the melding of a novel antimicrobial with aD printingPCL filamentthereby enabling the production of custom fit envelops for pacemakers and facilitating trouble free surgical implantationNarrative Through the development of an antimicrobial envelope for cardiovascular implantable electronic devicesCIEDsi epacemakers and implantable cardioverter defibrillatorsSaranas will greatly reduce the incidence of infections associated with the implantsReducing the number of CIED related infections will also greatly reduce the cost of care for these patientswhich increase by $per patient when an infection is acquired