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）：微技术和Invengen Engineering将设计并展示微创动态眼刀片，该刀片将使用“减少力”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，另一个用于中央静脉导管的放置。 ROC'BTM共振驱动的眼刀片将减轻眼部组织创伤并提供一致的刀片清晰度，以帮助减少微创眼科手术期间的伤口泄漏，而RVE'NTM rve'NTM，共振驱动的血管入口针头将减少毒气部位的创伤部位，从而最大程度地减少感染风险。这两种医疗设备都将利用新的轻巧，低功率，低成本的压电传感器来利用创新的夏普运动控制技术，以减少力效应以减少组织创伤。当刺穿和/或切割装置以高频（以较小的位移）和受控运动振动时，力效应的降低会发生并呈现手术益处。施加到尖端或尖锐的尖端以穿透并切开组织的必要力显着降低。降低切割力会导致均匀的切口，没有泪水或标签，尤其是通过descemet的膜，可能会导致更好的伤口置术最小化或阻止眼表液的进入，这些液体怀疑是在白内障手术后引起感染的。力效应的减少也可以应用于导管插入。较低的切口力意味着减少脉管系统的滚动，并可能导致较高的血管接入成功率，从而最大程度地减少导管伤口创伤。原理I期研究的演示将通过对压电传感器和运动约束设备进行有限元来实现，然后制造和组装成原型，该原型将用于牛眼测试。将生成Roc'B初步设备设计，以促进II期制造和在临床评估期间对刀原型进行测试。 RVE'NTM导管介绍器的原理证明将在II阶段类似地处理。作为每家公司的居民专业知识（IVG＆MMECH）的一部分，开发了两项技术创新，并吸引了两个大型医疗设备OEM（Alcon Laboratories＆Arrow International）的兴趣，他们可能会选择以这些新产品的积极证明来投入市场。相关性 - 如果每天在美国进行的大约7,700次白内障手术，则有400例患者有内脑炎感染的风险，并且在白内障手术后可能会失去视力丧失。估计每年发生200,000个医院（医院获得）血液感染；这些感染大多数与使用血管内装置有关。低力外科刀和针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。