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

描述(申请人提供)：微电子机械公司和英文吉工程公司将设计并展示一种微创动态眼刀片，该刀片将利用“减力”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‘BTM共振驱动眼刀将减少眼组织创伤，并提供一致的刀片锐度，以帮助减少微创眼科手术中的伤口渗漏，以及RVE’NTM，共振驱动血管进入针将减少静脉穿刺点创伤，将感染风险降至最低。这两种医疗设备都将利用创新的Sharps运动控制技术和新的轻便、低功率、低成本的压电换能器来减少力效应，以减少组织创伤。当穿孔和/或切割设备以高频(具有小的位移)和可控的运动进行振动时，力效应的减小发生并且表现出手术益处。显著降低了施加在刀刃或尖端以穿透和切割组织的必要的力。较低的切削力可以产生均匀的伤口，没有撕裂或标签，特别是穿过Descemet膜，并可能导致更好的伤口对位，最大限度地减少或防止怀疑会导致白内障手术后感染的眼表液体进入。力效应的减弱也可应用于导管插入。较低的切割力意味着较少的血管滚动和潜在的较高的血管进入成功率，从而将导管伤口部位的创伤降至最低。第一阶段的原理研究演示将通过对压电换能器和运动约束装置进行有限元建模，然后制造和组装成将用于牛眼测试的原型来完成。在临床评估期间，将生成ROC‘B初步设备设计，以促进刀原型的第二阶段制造和测试。RVE‘NTM导管引入器的原理演示将在第二阶段进行类似的处理。作为每家公司(IVG和MMECH)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设备OEM(爱尔康实验室和Arrow International)的兴趣，他们可能会选择将这些新产品推向市场，直到这项工作提供的原理得到积极演示。相关性-如果美国每天进行大约7700例白内障手术，每400名患者中就有一名患者面临眼内炎感染的风险，并可能在白内障手术后失去视力。据估计，每年发生200,000例医院内(医院获得性)血流感染；这些感染大多与血管内装置的使用有关。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.