A Biodegradable Vascular Coupling Device for End-to-End Anastomosis

Project Summary The objective of Microsurgical InnovationsMSIin this proposal is to develop a biodegradable vascular coupling deviceVCDwhich would replace the hand suturing technique currently used to connect arteries and veins in microvascular and macrovascular end to end vascular repair surgeriesOur device works for both arteries and veins and can rapidly connect the two vessel ends together in a watertight seal without leaving any foreign material in the lumen to come in contact with flowing bloodWe have manufactured prototype devices using biodegradable poly lactic acid co caprolactonePLACLPLA andcaprolactonewith no moving parts in multiple sizes to accommodate varying vessel size in a range of vascular repair scenariosThis device has similarities to the already available Synovis vein coupling devicenow part of Baxterin that it will be made of biocompatible materialsbut significantly differs from the Synovis device in that it does not have any metallic partsis completely biodegradablecan be used easily for both arteries and veins and the anastomosis can be performed much more rapidlyThis approach would reduce the time required in the surgery suitereduce costs associated with surgeryand reduce the likelihood of failure of the anastomosisby minimizing human error and stenting open the anastomosisThe biodegradable device will be useful in cases of chronic need of increased blood flow requirement e ghypoxia or growing childOur product will contain a sizing toolinner ring betweenmm tomm atmm intervals and a gap between the inner ring and outer ring ranging frommmmm andmmand installation toolsThe technology at the center of this proposal has been developed at the University of Utah and has been licensed to MSIa recent spin out company from the UniversityWe have produced a series of prototypes betweenmm size range that are applicable to microsurgery and have tested our device successfully in multiple animals fortomonth long studiesMultiple papers by our team have been published in the last few yearsFor successful commercialization of this device we need toidevelop and characterize devices for small caliber vesselscustomer need identified by interviewing oversurgeonsiilong term studydevice degradationintima to intima healingpatencyiiimold and tool development with manufacturing in GMP certified facilitiesiVbiocompatibility testingandVK applicationSpecific aims are geared towards moving MSI s VCD through product commercialization pipeline as reflected by our research strategyAs part of state and university funded lean canvas cohortswe conducted more thaninterviewsandgtsurgeons includingat the Mountain West Plastic Surgery Society meeting in Marchhosted by Jay AgarwalWe learned that the readiness of the device for market acceptance required that the overall size of the VCD be reduced by aboutthat demonstration oftomm devices was neededand comparison data with gold standards was desiredOur Aims for Phase II reflect this learning in addition to doing work necessary to obtain regulatory approvalHypothesisThe biodegradable vascular coupling device can provide the necessary coupling strength in physiological conditions formm tomm blood vesselsSpecific AimTo evaluate the functionality of vascular coupling devicesmm tomm diameter ex vivo HypothesisVascular anastomosis can be performed with the biodegradable vascular coupling device in vivo for small caliber vesselsmm tomm diameterThe implantation will not affect blood vessel patency and no severe foreign body response will occurSpecific AimTo evaluate the effectiveness and performance of small diameter biodegradable coupling devices in vivoHypothesisVascular anastomosis time with the biodegradable vascular coupling device will be lower than gold standard methodsSpecific AimTo evaluate the effectiveness and compare performance of the biodegradable coupling device in vivo with gold standards for larger diameter artery and veintommHypothesisAThe PLA based vascular coupling device can be manufactured using GMP certified facilitiesBThe PLACL based vascular coupling device is biocompatibleSpecific AimATo manufacture vascular coupling device molds and partsBTo conduct comprehensive biocompatibility testing with a third partyNelson laboratoriesfor MSI s vascular coupling device Project Narrative The objective of Microsurgical InnovationsMSIin this proposal is to develop a biodegradable vascular coupling deviceVCDwhich would replace the hand suturing technique currently used to connect arteries and veins in microvascular and macrovascular end to end vascular repair surgeries