Novel Dissipative Total Disc Replacement for Restoration of Natural Motion for Treatment of Degenerative Disc Disease

项目摘要 退行性腰椎间盘疾病是一种椎间盘完整性丧失的情况，被认为几乎发生在 60岁以上的人。在许多情况下，下腰痛与腰椎间盘高度作为神经的特征塌陷有关。 变得狭窄，脊柱的生物力学改变。当疾病进展到引起显著疼痛时，患者 医生可能会选择手术治疗--最常见的是脊柱融合术，也就是塑料或金属垫片(即椎间融合器)。 植入受影响的椎骨之间，以恢复适当的椎间盘高度。然后，骨骼就可以在椎骨之间有序生长 以永久固定那部分脊椎。与脊柱融合相关的挑战数不胜数， 包括生物力学的改变、融合器的下沉和迁移。为了克服这些挑战，外科医生们 正在转向一种新型的植入物：全盘置换(TDR)。不是刚性的笼子，而是一种装置，它保留了一些 使用了盘空间中的运动范围，然而，当前的解决方案不能完全复制自然运动，并且已经证明 在解决腰椎DDD问题上面临重大挑战。建议的解决方案将恢复 通过将液晶弹性体(LCE)的独特耗散特性结合到设备的核心中来实现本机盘 而多孔3D打印钛终板与下、上椎体连接，促进骨长入。我们 假设骨传导3D打印钛晶格和耗散LCE在 单成分TDR可以恢复椎间盘的固有功能。液晶弹性体是一种独特的 一种类似于天然软骨的材料，它将长程分子有序与网络弹性结合在一起，可以 恢复生物力学，同时提供出色的减震效果。这些材料已经被研究了几十年，但 直到最近才发现了一种合适的合成技术，使其能够大规模生产和商业化。这 这项技术涉及硫醇/丙烯酸酯点击反应，该反应以前已应用于其他生物材料，如牙科 粘合剂。然而，LCEs与3D打印钛的粘接性能还没有得到很好的研究。因此，第一个 本研究的目的是研究LCEs在多孔3D打印钛上的粘附性，以满足FDA的要求 关于粘接强度的建议。这项研究的第二个目标是创建一个具有临床应用的原型装置 ASTM 2346人工脊柱静态和动态特性的标准试验方法的合作者和测试 光盘。提出的装置通过使用先进的材料和制造来改进现有的TDR技术来恢复 永久的，自然的脊椎运动。该团队将由罗斯·沃尔普(Pi)组成，他带来了生物医学方面的经验 使用LCE和3D打印钛的器件制造和表征；Nathan Evans，他领导了 Restor3d Inc.各种3D打印钛植入物的开发和商业化 Impressio的科学家，拥有近十年为生物医学设备优化LCE的经验；以及Vikas Patel博士 和菲利普·霍恩医学博士，他们都是在治疗DDD方面有经验和成就的脊柱外科医生。

Project Summary Degenerative disc disease is a condition of loss of integrity of the intervertebral disc, and is thought to occur in nearly every person over 60 years old. In many cases, low back pain is associated with the characteristic collapse of disc height as nerves become constricted and biomechanics of the spine change. When the disease progresses to cause significant pain, patients and doctors may choose surgical intervention – most commonly spinal fusion where a plastic or metal spacer (i.e. cage) is implanted between the affected vertebrae to restore proper disc height. Bone can then grow between the vertebrae in order to permanently immobilize that section of the spine. There are a myriad of challenges associated with the spinal fusion, including altered biomechanics, subsidence and migration of the fusion cage. To overcome these challenges, surgeons have been turning to a new type of implant: a total disc replacement (TDR). Instead of a rigid cage, a device which retains some range of motion in the disc space is used, however, current solutions fail to fully replicate natural motion and have proven to have significant challenge addressing DDD in the lumbar spine. The proposed solution will restore the functionality of native disc by incorporating the unique dissipative properties of liquid crystal elastomers (LCEs) in the core of the device while porous 3D printed titanium endplates interface the inferior and superior vertebrae to facilitate boney ingrowth. We hypothesize that the cooperative functionality of an osteoconductive 3D printed titanium lattice and dissipative LCE in a single-component TDR can restore native functionality of the intervertebral disc. Liquid crystal elastomers are a unique class of materials which, similar to natural cartilage, combine long range molecular order with network elasticity and can restore biomechanics while providing excellent shock absorption. These materials have been investigated for decades, yet only recently has a suitable synthetic technique been discovered to enable bulk manufacturing and commercialization. This technique involves a thiol/acrylate click reaction, which has previously been applied in other biomaterials such as dental adhesives. However, the adhesive properties of LCEs to 3D printed titanium has not been well studied. As such, the first aim of this study is to investigate the adhesive properties of LCEs to porous 3D printed titanium, with the goal to meet FDA recommendations for adhesive strength. The second aim of this study is to create a prototype device with clinical collaborators and test to ASTM 2346, Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs. The proposed device improves on current TDR technology by using advanced materials and manufacturing to restore permanent, natural motion to the spine. The team will consist of Ross Volpe (PI), who brings experience in biomedical device fabrication and characterization using both LCEs and 3D printed titanium; Nathan Evans, who has led the development and commercialization of a variety of 3D printed titanium implants at Restor3d Inc.; Amir Torbati, Principal Scientist at Impressio with almost a decade of experience optimizing LCEs for biomedical devices; and Dr. Vikas Patel MD and Dr. Philip Horne MD who are experienced and accomplished spine surgeons with expertise in treating DDD.