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

共振驱动的眼片可减少眼组织损伤并提供一致的治疗效果

• 批准号: 7272251
• 负责人: ALFREDO VAZQUEZ CARAZO
• 金额: $ 9.97万
• 依托单位: MICROMECHATRONICS, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-02-01 至 2009-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7272251
• 关键词: 3-Dimensional; Accounting; Address; Angiography; Angioplasty; Anterior; Area; Arts; Asians; Bacteria; Bite; Blindness; Blood Vessels; Body Surface; Bone marrow biopsy; Bos taurus; Boston; Cannulas; Cardiac; Cardiology; Caring; Cataract; Cataract Extraction; Catheterization; Catheters; Cattle; Clinical Trials; Condition; Cornea; Corneal Stroma; Coronary; Coronary Atherectomy; Critical Care; Culicidae; Daily; Descemet' s membrane; Development; Device Designs; Devices; Dialysis procedure; Diamond; Drainage procedure; Electrophysiology (science); Elements; Endophthalmitis; Engineering; Enzymes; European; Extravasation; Eye; Far East; Fertilization in Vitro; Frequencies; Germany; Goals; Growth; Hand; Heating; Hospitals; Industry; Infection; International; Intravenous infusion procedures; Invasive; Kidney; Laboratories; Left; Liquid substance; Local Anesthetics; Magnetism; Manufacturer Name; Marketing; Measures; Mechanics; Medical Device; Metals; Methods; Microsurgery; Modeling; Motion; Names; Needles; Neonatal; Neurology; Numbers; Operative Surgical Procedures; Ophthalmologic Surgical Procedures; Ophthalmology; Organ; Outcome; Participant; Pathway interactions; Patients; Pattern; Penetration; Phacoemulsification; Phase; Physical Dialysis; Placement; Plastic Surgical Procedures; Positioning Attribute; Price; Procedures; Program Development; Prosthesis; Puncture procedure; Rate; Recovery; Research; Risk; Sales; Saline; Scandinavia; Scientist; Sclera; Sepsis; Side; Simulate; Site; Skin; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Source; Standards of Weights and Measures; Structure of subclavian vein; Surface; Surgeon; Surgical Instruments; Surgical incisions; Syringes; Techniques; Technology; Temperature; Test Result; Testing; Tissues; Toothbrushing; Transducers; Trauma; Ultrasonic Transducer; Ultrasonics; Ultrasonography; United Kingdom; Urology; Veins; Venipunctures; Venous; Work; Wound Healing; anterior chamber; base; commercialization; conjunctiva; cost; design; desire; improved; innovation; interest; lens; new technology; prevent; programs; prototype; research clinical testing; research study; seal; skills; success; tissue trauma; tool; toothbrush; vibration; wound

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.

描述（由申请人提供）：微机电和Invengen工程公司将设计和演示一种微创动态眼刀片，该刀片将使用“减力”效应来减少组织创伤。这项工作的长期目标是使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，并提供一致的刀片锋利度，以帮助减少微创眼科手术中的伤口渗漏；RVE'NTM共振驱动血管进入针将减少静脉穿刺部位的创伤，最大限度地降低感染的风险。这两种医疗设备将利用创新的锋利运动控制技术和新型轻质、低功耗、低成本的压电传感器来减少力的影响，以减少组织创伤。当穿刺和/或切割装置以高频振动（小位移）和控制运动时，力效应的减少发生并呈现手术效益。应用于切削刃或锋利点以穿透和切割组织的必要力量显着减少。较低的切割力导致切口均匀，没有撕裂或标签，特别是通过Descemet膜，可能导致更好的伤口放置，最大限度地减少或防止被怀疑引起白内障手术后感染的眼表面液体的进入。减力效应也可应用于导管插入。较低的切口力意味着更少的血管滚动和潜在的更高的血管进入成功率，从而最大限度地减少导管伤口部位的创伤。第一阶段的研究原理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。ROC'B初步装置设计将生成，以促进临床评估期间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II期进行类似的处理。作为每家公司（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设备OEM（爱尔康实验室和阿罗国际）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示范原则。相关性-如果美国每天进行大约7700例白内障手术，400例患者中就有1例面临白内障手术后眼内炎感染和潜在视力丧失的风险。据估计，每年发生20万例医院获得性血液感染；这些感染大多与使用血管内装置有关。低力手术刀和针头的发展将为临床医生提供新的手术技术选择，以减少切口创伤。