Nanotechnology Enabled Temporomandibular Joint (TMJ) Prosthesis

描述(申请人提供)：颞下颌关节紊乱病(TMD)通常是一组影响颞下颌关节(TMJ)和/或咀嚼肌肉以及邻近组织结构的医学和牙科疾病。对于一些严重的TMJ退行性变的患者，可能需要假体置换。然而，目前的植入物设计的长期成功和功能仍然是一个严重的问题，这在很大程度上是由于磨屑导致植入物和周围组织的恶化。在该项目中，UAB和Vista Engineering团队将为TMJ设备中的关节部件开发具有增强附着力和耐磨性的新型多层纳米结构金刚石涂层。我们还将通过扩大规模和TMJ磨损测试来开发商业化潜力。UAB和Vista Engineering有着良好的合作记录，最终获得了UAB的一项专利许可(授予Vista Engineering)，该专利涉及这项技术：“金属上超光滑钻石涂层及其用途的工艺”，专利#6,183,818。我们的具体目标如下：具体目标1：开发纳米技术，通过化学气相沉积(CVD)具有多层结构的超光滑金刚石涂层来减少TMJ金属植入物(髁突和颅窝)关节承重组件的摩擦和磨损。将对金刚石涂层进行双向弯曲、压痕和周向加载力学测试，以确定导致剥落的力。我们将研究这些超光滑涂层(用于钻石对钻石铰接)的销盘耐磨性，并与目前商用TMJ设备中使用的单层钻石对钻石铰接或金属对聚乙烯或金属对金属偶件进行比较。在开发金刚石涂层的同时，我们将利用有限元建模和分析(FEM/FEA)方法来评估最终TMJ植入物设计的形状、尺寸、关键尺寸和生物动力学稳定性。具体目标2：展示在Vista Engineering使用商用30千瓦CVD反应堆进行放大的能力。我们将设计和制造具有多层纳米结构金刚石涂层的TMJ植入设备，用于髁突和颅窝组件。在这项第一阶段赠款中，商业化生产的TMJ植入物将在TMJ模拟器中接受广泛的测试，测试周期为112.5万个周期(大约相当于10年的临床使用)。这项研究的成功结果将是TMJ设备和涂层的改进设计，以实现硬对硬连接。钻石对钻石组件的一个好处是减少了设备的总体尺寸，最终将允许临床上较少侵入性的关节修复途径和更长的体内植入寿命。TMJ装置将减少关节表面的长期磨损。该项目将导致第二阶段的应用，包括通过将关节磨损碎片植入大鼠滑膜状气囊中进行颗粒反应，然后将涂覆的TMJ装置植入小型猪模型。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)植入物和周围组织之间的界面。据估计，仅在美国就有1000多万人患有与TMJ相关的障碍症状。这项赠款申请的主要重点是改善TMJ种植体的固定、耐用性和骨整合，以获得长期的成功，并降低反复进行多次手术的需要。此外，新的纳米技术工具和方法的开发将导致用于生物医学植入行业的钛和钴铬合金的新型功能化纳米结构表面。钻石-钻石组件的一个好处是减少了整体装置的尺寸，最终将允许临床上较少侵入性的关节修复途径和更长的体内植入寿命。我们还为纳米技术支持的TMJ假体的商业化提供了一条明确的途径。

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.