Nanotechnology Enabled Temporomandibular Joint (TMJ) Prosthesis

纳米技术支持的颞下颌关节 (TMJ) 假体

• 批准号: 7665281
• 负责人: Raymond G. Thompson
• 金额: $ 17.17万
• 依托单位: VISTA ENGINEERING, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2011-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7665281
• 关键词: Adhesions; Affect; Air; Alloys; Applications Grants; Architecture; Arts; Biological; Biomedical Engineering; Brain; Chemical Engineering; Chemicals; Clinical; Cobalt; Collaborations; Collection; Couples; Dental; Deposition; Deterioration; Development; Device Designs; Devices; Diamond; Dimensions; Disease; Ear; Elements; Engineering; Eye; Failure; Fossa; Friction; Grant; Implant; Industry; Joint Prosthesis; Joints; Lead; Legal patent; Licensing; Masticatory muscles; Mechanics; Medical; Metals; Methods; Miniature Swine; Modeling; NIH Program Announcements; Nanotechnology; Nerve; Operative Surgical Procedures; Orthopedics; Osseointegration; Osteolysis; Outcome Study; Pain; Particulate; Pathway interactions; Patients; Performance; Phase; Polyethylenes; Process; Property; Prosthesis; Rattus; Reaction; Recurrence; Replacement Arthroplasty; Research; Resistance; Route; Shapes; Structure; Surface; Symptoms; Technology; Temporomandibular Joint; Temporomandibular Joint Disorders; Testing; Tissues; Titanium; United States; Weight-Bearing state; base; commercial application; commercialization; design; implantable device; implantation; improved; in vivo; nano; nanostructured; novel; public health relevance; response; restoration; sample fixation; scale up; simulation; success; technological innovation; tool; vapor

DESCRIPTION (provided by applicant): Temporomandibular Disorders (TMD) usually represent a collection of medical and dental conditions affecting the temporomandibular joint (TMJ) and/or the muscles of mastication, as well as contiguous tissue structures. For some patients with severe TMJ degeneration, a prosthetic replacement may be required. However, long-term success and functioning of current implant designs remains a serious problem due, in large part, to the deterioration of the implant and surrounding tissue resulting from wear debris. In this project, the UAB and Vista Engineering team will develop novel multilayer nanostructured diamond coatings with enhanced adhesion and wear properties for articulation components in TMJ devices. We will also develop commercialization potential through scale-up and TMJ wear testing. UAB and Vista Engineering have a strong track record of collaboration culminating in the licensing (to Vista Engineering) of a UAB patent involving this technology: "Process for Ultra Smooth Diamond Coating on Metals and Uses Thereof", Patent # 6,183,818. Our specific aims are as follows: Specific Aim 1: Develop nanotechnology for reducing friction and wear on the articulating, load-bearing components of TMJ metallic implants (condyle and fossa) by chemical vapor deposition (CVD) of an ultra-smooth diamond coating having a multilayer structure with alternating nano- and micro-structural layered components. Biaxial flexural, indentation, and perimeter loading mechanical tests of the diamond coatings will be performed to determine forces that cause spallation. We will investigate the pin-on-disk wear-resistance of these ultra-smooth coatings (intended for diamond-on-diamond articulation) as compared to single-layer diamond-on-diamond articulation or to the metal-on-polyethylene or metal-on-metal couples currently used in commercial TMJ devices. In parallel to developing diamond coatings, we will utilize a finite element modeling and analysis (FEM/FEA) approach in order to evaluate shapes, sizes, critical dimensions and biodynamic stability of the final TMJ implant designs. Specific Aim 2: Demonstrate the capability for scale-up using the commercial 30 kW CVD reactor at Vista Engineering. We will design and fabricate TMJ implant devices that have a multilayer nanostructured diamond coating for both condyle and fossa components. In this Phase-I grant, the commercially produced TMJ implant will undergo extensive testing in a TMJ simulator to 1.125 million cycles (approximately the equivalent of 10 years clinical use). The successful outcome of this study will be an improved design for TMJ devices and coatings for hard-on-hard articulation. One benefit of the diamond-on-diamond components will be a reduction in overall device size that will ultimately allow for a clinically less-invasive route to joint restoration and longer implant lifetime in vivo. The TMJ device will result in less long-term wear at articulating surfaces. This project will lead to a phase-II application involving particulate reaction by implantation of articulating wear debris into a rat synovial-like air pouch, followed by implantation of the coated TMJ device into a minipig model. PUBLIC HEALTH RELEVANCE: We propose the use of nanotechnology approaches for controlling interfaces between Temporomandibular Joint (TMJ) implants and the surrounding tissues. It is estimated that more than 10 million people suffer from the TMJ-related disorder symptoms in the Unites States alone. The primary focus of this grant application is to improve the fixation, durability and osseointegration for long-term success of TMJ implants and lower the need for recurrent multiple surgical procedures. Also, development of new nanotechnology tools and methods will lead to a new class of functionalized nanostructured surfaces for titanium and cobalt chrome alloys for use in biomedical implant industry. One benefit of the diamond-diamond components will be reductions in overall device size that will ultimately allow for a clinically less-invasive route to joint restoration and longer implant lifetime in vivo. We also propose a clear pathway for commercialization of the nanotechnology enabled TMJ prosthesis.

描述（由申请人提供）：颞下颌疾病（TMD）通常代表影响颞下颌关节（TMJ）和/或咀嚼肌肉以及连续组织结构的医疗和牙科疾病的集合。对于某些严重TMJ变性的患者，可能需要修复假体。但是，由于磨损碎屑导致的植入物和周围组织的恶化，当前植入物设计的长期成功和当前植入物设计的功能仍然是一个严重的问题。在这个项目中，UAB和Vista工程团队将开发新颖的多层纳米结构钻石涂料，具有增强的粘附和磨损特性，可用于TMJ设备中的发音组件。我们还将通过扩展和TMJ磨损测试来开发商业化潜力。 UAB和VISTA工程具有很强的协作记录，最终是UAB专利的许可（Vista Engineering），涉及这项技术：“用于金属上的超光滑钻石涂层的过程”，专利＃6,183,818。我们的具体目的如下：具体目的1：开发纳米技术，以减少TMJ金属植入物（Condyle and Fossa）的发音，承载成分（通过化学蒸气沉积（CVD））的超高钻石涂层的多层层层结构具有多层层层结构和MICKOROREDRESTRESTROSERISTRORTARTIST的超水平钻石结构的摩擦和磨损。将对钻石涂层的双轴弯曲，凹痕和周长装载机械测试，以确定引起散布的力。我们将研究这些超平滑涂层（用于钻石钻石在钻石上的钻石表达）的二型二烟磨损，与单层钻石钻石表达相比，或当前在商业TMJ设备中使用的金属乙烯或金属对金属夫妇。与开发钻石涂料并行，我们将利用有限的元素建模和分析（FEM/FEA）方法来评估最终TMJ植入物设计的形状，大小，临界维度和生物动力学稳定性。特定目标2：使用Vista Engineering的商业30 kW CVD反应堆进行扩展的能力。我们将设计和制造TMJ植入设备，该设备具有多层纳米结构的钻石涂层，用于Condyle和Fossa组件。在此阶段I赠款中，商业生产的TMJ植入物将在TMJ模拟器中进行广泛的测试至11.25亿个周期（大约相当于10年的临床使用）。 这项研究的成功结果将是针对TMJ设备和涂料的改进设计。钻石上钻石组件的一个好处将减少整体设备尺寸，这最终将允许在临床上进行关节恢复和较长的植入寿命在体内的侵入性途径。 TMJ设备将在铰接表面上导致长期磨损较少。该项目将导致II期应用，涉及颗粒反应，通过将磨损碎屑植入大鼠滑膜样气袋中，然后将涂层的TMJ设备植入Minipig模型。 公共卫生相关性：我们建议使用纳米技术方法来控制颞下颌关节（TMJ）植入物与周围组织之间的接口。据估计，仅在Unites州，超过1000万人患有与TMJ相关的疾病症状。该赠款应用的主要重点是改善TMJ植入物长期成功的固定性，耐用性和骨整合性，并降低对多次手术程序的复发需求。此外，新的纳米技术工具和方法的开发将导致一类新的功能化纳米结构化表面，用于钛和钴铬合金，用于生物医学植入物行业。 Diamond-Diamond组件的一个好处将减少整体设备尺寸，这最终将允许在临床上进行关节恢复和较长的植入寿命在体内的侵入性途径。我们还提出了纳米技术的商业化启用TMJ假体的明确途径。