Micromechatronics and Invengen Engineering will design and demonstrate a minimally invasive dynamic ocular blade that will use the 'reduction of force' effect to reduce tissue trauma. The long-term objective of this work is to commercialize two surgical procedure products; one used in cataract surgery, the other in the placement of central venous catheters. The ROC'BTM Resonance-driven OCular Blade will Reduce Ocular Tissue Trauma and Provide Consistent Blade Sharpness to Help Reduce Wound Leakage during Minimally Invasive Eye Surgery and the RVE'NTM, Resonance-driven Vascular Entry Needle which will Reduce Venipuncture Site Trauma Minimizing the Risk of Infection. Both medical devices will leverage an innovative sharps motion control technology with new lightweight, low power, low cost piezoelectric transducers to create the reduction of force effect to reduce tissue trauma. The reduction of force effect occurs and presents surgical benefit when the piercing and/or cutting device is vibrated at high frequency (with small displacements) and controlled motion. The necessary force applied to the cutting edge or sharp point to penetrate and incise tissue is significantly reduced. Lower cutting forces result in uniform incisions, without tears or tags, especially through Descemet's membrane and may result in better wound apposition minimizing or preventing ingress of eye surface fluids which are suspected of causing infections following cataract surgery. The reduction of force effect can also be applied to catheter insertion. Lower incision forces mean less rolling of vasculature and potentially a higher vessel access success rate which minimizes catheter wound site trauma. The Phase I research demonstration of principle will be accomplished by finite element modeling the piezoelectric transducers and motion constraining devices then fabricating and assembling into a prototype that will be used in testing on a bovine eye. A ROC'B preliminary device design will be generated to facilitate Phase II fabrication and testing of knife prototypes during clinical evaluation. Demonstration of principle for the RVE'NTM Catheter Introducer will be handled similarly in Phase II. Two technology innovations were developed as part of the resident expertise of each company (IVG & MMECH) and have attracted the interest of two large medical device OEM's (Alcon Laboratories & Arrow International) who may elect to go to the market with these new products pending a positive demonstration of principle furnished by this work. Relevance - Out if the approximately 7,700 cataract procedures conducted in the US daily, one patient in 400 is at risk for endophthalmitis infection and potentially loss of vision following cataract surgery. An estimated 200,000 nosocomial (hospital-acquired) bloodstream infections occur each year; most of these infections are related to the use of an intravascular device. Development of low force surgical knives and needles will provide clinicians with new surgical technique options to reduce incision trauma. ? ? ?
