ECLIPSE ORTHOPAEDICS, LLC — Department of Health and Human Services SBIR Phase I: NIAMS

Description

Abstract Aboutleg and hip fractures each year are treated by implanting a stiff metal rod or intramedullaryIMnailthrough the center of the bone and fixing the ends of the nail to the bone with screwsBut placing the locking screws to fix the rod to the bone is difficultTo anchor the nail securelythe surgeon must accurately drill pilot holes through both the bone and locking holes in the nailwhile the nail is hidden from viewThis challenging taskcalled distal lockingis typically completed using C arm fluoroscopy for guidanceDifficulty completing distal locking affects patients by causing longer surgery timesadditional blood loss and radiation exposurepossible malrotation of the extremityand the risk of fracture in the area of the distal holes due to bone defects caused by re drillingSurgeons are affected primarily by the repeated radiation exposurewhile the challenges lead many general orthopedic surgeons to refer patients to specialiststhese surgeries are often only performed by specialists at Levelor Leveltrauma centersA more accurate and safer way to locate distal holes is needed to improve patient outcomesa method that is easy to perform could also reduce costs and increase access to careBased on patented technologyEclipse Orthopaedics is developing a fluoroscopic targeting devicethe Radiographic Targeting AttachmentRTAthat will put both targeting and drilling capabilities in the surgeonsandaposhandsThe RTA combines a small X ray source and a drill attachment thatwhen paired with the imager and drillwill become a fluoroscopically guided drill that locates and drills holes in one operationEclipse Orthopaedicsandaposoverall SBIR goal is to develop the RTA and license the technology to major trauma supplierswho will market the RTA as an integral part of their internal fixation product portfolioIn Phase IEclipse Orthopaedics willAimDesign and build a prototypeEclipse Orthopaedics and RoseHulman Ventures will make improvements to the current prototype and supporting software system in preparation for testingAimMeasure bench performance of prototypeEclipse Orthopaedics will evaluate performance in the lab in preparation for cadaver testing by actual surgeonsandAimEvaluate prototype in simulated surgical proceduresIn the simulated surgical proceduresorthopaedic surgeons of different experience and skill levels recruited from area hospitals will perform distal locking of IM nails in cadaveric specimenscomparing the standard technique to the RTA methodAt the conclusion of Phase IEclipse Orthopaedics will have the key system performance data and more importantly the evaluations of target users of the RTA systemWith this informationEclipse will plan a comprehensive product development schedule to be executed in Phase IIEclipse Orthopaedicsandaposobjective is to develop the RTA and license the technology to major trauma supplierswho will market the RTA as an integral part of their internal fixation product portfolio Narrative A common and successful treatment for long bone fractures is the implantation of a stiff metal rodor intramedullaryIMnailthrough the center of the bone and fix the ends of the nail to the bone with screwsTo anchor the nail securelythe surgeon must accurately drill pilot holes through both the bone and locking holes in the nailwhile the nail is hidden from viewThis challenging task and often results in longer surgery timeadditional blood loss and radiation exposure and a risk of malrotation of the extremityIn this SBIREclipse Orthopaedics will develop a device to significantly improve the freehand targeting of IM nails based on Eclipseandapos s patented technology