Resonance-driven Ocular Blade Reduces Ocular Tissue Trauma and Provides Consisten

描述（由申请人提供）：Micromechatronics和Invengen Engineering将设计并证明一种微创动态眼部刀片，该刀片将使用“力的减少”效应来减少组织创伤。这项工作的长期目标是将两种外科手术产品商业化;一种用于白内障手术，另一种用于放置中心静脉导管。ROC的BTM共振驱动眼科刀片将减少眼组织创伤，并提供一致的刀片共享，以帮助减少微创眼科手术中的伤口渗漏，RVE的NTM，共振驱动血管穿刺针将减少静脉穿刺部位创伤，最大限度地降低感染风险。这两种医疗器械都将利用创新的锐器运动控制技术，采用新型轻质、低功耗、低成本压电换能器，以减少力效应，从而减少组织创伤。当穿刺和/或切割装置以高频振动（具有小位移）和受控运动时，力效应的减小发生并呈现手术益处。施加到切割刃或锋利点以穿透和切割组织所需的力显著减小。较低的切割力导致切口均匀，无撕裂或标签，特别是通过后弹力膜，并可能导致更好的伤口贴壁，最大限度地减少或防止怀疑引起白内障手术后感染的眼表面液体进入。力效应的减小也可以应用于导管插入。较低的切口力意味着血管滚动较少，可能会提高血管入路成功率，从而最大限度地减少导管伤口部位创伤。第一阶段的研究演示的原则将完成有限元建模的压电换能器和运动约束装置，然后制造和组装成一个原型，将用于测试牛眼。将生成ROC 'B初步器械设计，以便于在临床评价期间进行II期制造和刀片原型测试。RVE'NTM导管导引器的原理证明将在第II阶段进行类似处理。作为两家公司（IVG和MMECH）的常驻专业知识的一部分，开发了两项技术创新，并吸引了两家大型医疗器械OEM（Alcon Laboratories和Arrow International）的兴趣，他们可能会选择将这些新产品推向市场，等待这项工作提供的积极证明。相关性-如果在美国每天进行约7，700例白内障手术，则每400例患者中就有1例存在眼内炎感染风险，并可能在白内障手术后丧失视力。据估计，每年发生200，000例医院（医院获得性）血流感染;这些感染中的大多数与血管内器械的使用有关。低力手术刀和针的开发将为临床医生提供新的手术技术选择，以减少切口创伤。

DESCRIPTION (provided by applicant): 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.